Covidien PB980 Operator's Manual

Covidien PB980 is a highly advanced ventilator designed to provide a wide range of ventilation therapies for both invasive and non-invasive patients. It features an intuitive graphical user interface, comprehensive monitoring capabilities, and advanced safety features. Other important features of the PB980 are listed below:

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Puritan Bennett™

980 Series Ventilator

Operator's Manual

0123

COVIDIEN, COVIDIEN with logo and Covidien logo are trademarks of Covidien. Third-party trademarks (“TM*”) belong to their respective owners.

The following list includes trademarks or registered trademarks of a Covidien entity in the United States and/or in other countries.

Argyle™, DAR™, F&P™, IE Sync™, PAV+™, Puritan Bennett™, Shiley™

Copyright Information

U.S. Patents: www.covidien.com/patents.

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company.

The information contained in this manual is the sole property of Covidien and may not be duplicated without permission. This manual may be revised or replaced by Covidien at any time and without notice. Ensure this manual is the most current applicable version. If in doubt, contact

Covidien’s technical support department.

While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment.

The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated in the limited warranty provided.

Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.

Covidien is a Medtronic company. The names Covidien and Medtronic are used interchangeably throughout this manual.

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.2 Global Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

1.6 Manufacture Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

1.7 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

1.8 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

2.2 Ventilator Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

2.3 Indications For Use/Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

2.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

2.5 Components List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

2.6 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

2.7 Mounting Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.8 Battery Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.9 Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

2.10 GUI Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

2.11 Breath Delivery Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

2.12 Additional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

2.13 Special Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

2.14 Color Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

2.15 Pneumatic Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

3.3 Product Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

3.4 Product Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

3.5 Product Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

3.6 Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

3.7 Ventilator Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

3.8 Product Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

3.9 Installation Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

3.10 Operation Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

4.2 Ventilator Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

4.3 Ventilator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

4.4 User Interface Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

4.5 Ventilator Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

4.6 Predicted Body Weight (PBW) Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

4.7 Non-invasive Ventilation (NIV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

4.8 Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

4.9 Respiratory Mechanics Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

4.10 Oxygen Sensor Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

4.11 Ventilator Protection Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

4.12 Ventilator Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

5 Product Data Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

5.2 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

5.3 Data Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

5.4 Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

5.5 Communication Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

5.6 Retrieving Stored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

5.7 Display Configurability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

5.8 Printing Data or Screen Captures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

5.9 Connectivity to External Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

6 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

6.2 System Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

6.3 Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

6.4 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

6.5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

6.6 Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

7 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

7.2 Ventilator Operational Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

7.3 Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

7.4 Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

7.5 Component Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

7.6 Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

7.7 Service Personnel Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

7.8 Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

7.9 Inspection and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

7.10 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

7.11 Storage for Extended Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

8 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

8.2 Problem Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

8.3 How to Obtain Ventilator Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

8.4 Used Part Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

8.5 Ventilator Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

8.6 Diagnostic Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

9 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

9.2 General Accessory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

10 Theory of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

10.2 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

10.3 Applicable Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

10.4 Inspiration — Detection and Initiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

10.5 Exhalation — Detection and Initiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

10.6 Compliance and BTPS Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

10.7 Mandatory Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

10.8 Spontaneous Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

10.9 A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

10.10 SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

10.11 Spontaneous (SPONT) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

10.12 Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

10.13 Detecting Occlusion and Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

10.14 Respiratory Mechanics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

10.15 Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

10.16 Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

10.17 Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241

10.18 Short Self Test (SST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242

10.19 Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242

11 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

11.2 Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

11.3 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

11.4 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

11.5 Interface Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

11.6 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

11.7 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

11.8 Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

11.9 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264

11.10 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

11.11 Essential Performance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

12 Appendix BiLevel 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

12.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

12.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

12.3 Setting Up BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

12.4 Using Pressure Support with BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

12.5 Manual Inspirations in BiLevel Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273

12.6 Respiratory Mechanics Maneuvers in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273

12.7 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273

12.8 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274

12.9 Mode Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276

13 Appendix Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

13.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

13.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

13.3 Safety Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

13.4 Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

13.5 Setting Up Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

13.6 When Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

13.7 Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280

14 Appendix PAV™+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

14.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

14.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

14.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

14.4 PAV+™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

14.5 Ventilator Settings and Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287

15 Appendix NeoMode 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

15.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

15.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

15.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

15.4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

15.5 Neonatal Door and Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295

15.6 How to Empty the Condensate Vial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296

15.7 How to Connect the Breathing Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

15.8 Ventilation Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298

16 Appendix Proximal Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

16.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

16.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

16.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

16.4 Proximal Flow Option Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304

16.5 Software and Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305

16.6 On-screen symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305

16.7 Sensor Calibration and Sensor Line Purging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307

16.8 SST Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307

16.9 Disabling and Enabling the Proximal Flow Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309

16.10 Using the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310

16.11 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312

16.12 Ranges, Resolutions, and Accuracies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

16.13 Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

17.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

17.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

17.3 Safety Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

17.5 Setting Up Trending . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

17.6 Trend Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316

17.7 Viewing Trended Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319

17.9 Data Gaps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331

Figures

Figure 1.

GUI Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Figure 2.

GUI Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Figure 3.

BDU Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Figure 4.

BDU Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Figure 5.

Installed Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Figure 6.

Ventilator Right Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Figure 7.

Ventilator Left Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Figure 8.

Ventilator Power Switch and AC Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Figure 9.

Service Mode Button (TEST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Figure 10.

Sample Status Display During Normal Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Figure 11.

Pneumatic Diagram (Compressor Shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Figure 12.

Pneumatic Diagram — Compressor and Prox Flow Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Figure 13.

Example of Freestanding Ventilator Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 14.

Example of Pendant-mounted Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 15.

Power Cord Retainer on BDU (without spacers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 16.

Power Cord Retainer on BDU (with spacers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 17.

Connecting the Ventilator to the Gas Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Figure 18.

Adult/Pediatric Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Figure 19.

Installing the Neonatal Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Figure 20.

Drain Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Figure 21.

Flex Arm Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Figure 22.

Bracket Installation on Rail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Figure 23.

Humidifier Installation to Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Figure 24.

Connecting the Adult or Pediatric Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Figure 25.

Connecting the Neonatal Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Figure 26.

Ventilator Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Figure 27.

Proper Battery Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Figure 28.

Battery Compartment Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Figure 29.

Battery Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Figure 30.

Battery Charge Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Figure 31.

Service Mode Button (TEST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Figure 32.

Areas of the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Figure 33.

Pushpin Icon – unpinned state . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Figure 34.

Pushpin Icon – pinned state . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Figure 35.

New Patient Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Figure 36.

Open Menu Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Figure 37.

New Patient Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Figure 38.

Apnea Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Figure 39.

Alarms Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Figure 40.

Alarm Screen during Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Figure 41.

Vent Setup Button “NIV” Indicating NIV Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Figure 42.

⤒ T

I SPONT

Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Figure 43.

Default NIV Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Figure 44.

RM in Menu Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Figure 45.

Respiratory Maneuver Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Figure 46.

More Settings Screen with O

Sensor Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Figure 47.

Incompatible USB Device Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Figure 48.

Comm Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Figure 49.

Port Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Figure 50.

Alarm Message Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Figure 51.

Static Compliance (C

STAT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 52.

Static Resistance (R

STAT

) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 53.

EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Figure 54.

EVQ Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Figure 55.

EVQ Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Figure 56.

Exhalation Valve Diaphragm Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Figure 57.

Exhalation Filter Seal Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Figure 58.

Pressure Sensor Filter Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Figure 59.

Immersion Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Figure 60.

EVQ Reprocessing Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

Figure 61.

Installing the Pressure Sensor Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Figure 62.

Installing the Pressure Sensor Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Figure 63.

Installing the Exhalation Filter Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Figure 64.

Installing the Diaphragm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Figure 65.

Installing the Diaphragm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

Figure 66.

Installing the EVQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Figure 67.

Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Figure 68.

Ventilator with Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Figure 69.

Additional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Figure 70.

General Feedback Control System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Figure 71.

Inspiration Using Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

Figure 72.

Inspiration Using Flow Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Figure 73.

Breath Activity During Time-triggered Inspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Figure 74.

Exhalation via the Airway Pressure Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

Figure 75.

Typical flow-cycled breath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Figure 76.

Square Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

Figure 77.

Descending Ramp Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

Figure 78.

Ideal Waveform Using Square Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Figure 79.

Ideal Waveform Using Descending Ramp Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Figure 80.

Ideal Waveform Using Pressure Control Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

Figure 81.

ET Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Figure 82.

Tracheostomy Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Figure 83.

No Patient Inspiratory Effort Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

Figure 84.

Patient Inspiratory Effort Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

Figure 85.

Combined VIM and PIM Breaths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Figure 86.

Mandatory and Spontaneous Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Figure 87.

PIM Delivered Within Mandatory Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Figure 88.

PIM Not Delivered Within the Mandatory Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Figure 89.

Apnea Interval Equals Breath Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Figure 90.

Apnea Interval Greater Than Breath Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Figure 91.

Apnea Interval Less Than Breath Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Figure 92.

Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

Figure 93.

Illustrated Modes and Breath Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

Figure 94.

Spontaneous Breathing at P

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

Figure 95.

BiLevel Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

Figure 96.

BiLevel Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

Figure 97.

BiLevel with Pressure Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273

Figure 98.

Spontaneous and Synchronous Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

Figure 99.

APRV With Spontaneous Breathing at P

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276

Figure 100.

Enabling Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

Figure 101.

GUI Screen when Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

Figure 102.

Leak Sync Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280

Figure 103.

Circuit Disconnect During VC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

Figure 104.

Ventilator Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

Figure 105.

Work [J/L] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288

Figure 106.

Graphics displays in PAV+™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289

Figure 107.

EQUATION 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290

Figure 108.

EQUATION 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290

Figure 109.

EQUATION 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290

Figure 110.

EQUATION 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291

Figure 111.

EQUATION 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

Figure 112.

Lung Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

Figure 113.

Use of Default Lung Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294

Figure 114.

Installing the Neonatal Filter and Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296

Figure 115.

How to Connect the Breathing Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

Figure 116.

CPAP Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300

Figure 117.

Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305

Figure 118.

Sample GUI screen Showing Proximal Flow Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306

Figure 119.

Message During Autozero and Purge Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307

Figure 120.

Attaching the Proximal Flow Sensor to the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309

Figure 121.

Enabling or Disabling Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310

Figure 122.

Attaching Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311

Figure 123.

Manual Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312

Figure 124.

Alarm Message — Prox Inoperative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

Figure 125.

Tables

Table 1.

Shipping Carton Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Table 2.

Safety Term Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Table 3.

Covidien US and International Service Centers, by Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Table 4.

Typical Packing List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Table 5.

BDU Front Label Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Table 6.

BDU Rear Label or Panel Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Table 7.

Common Symbols Found on GUI or BDU Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Table 8.

GUI Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Table 9.

GUI Visual Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Table 10.

Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Table 11.

GUI Audible Indicator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Table 12.

Status Display Indicators and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Table 13.

BDU Audible Indicator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Table 14.

Color Legend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Table 15.

Patient Types and PBW Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Table 16.

Example of Battery End of Service Life Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Table 17.

Ventilator Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Table 18.

SST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Table 19.

Humidifier Volumes for Adult and Pediatric Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Table 20.

Humidifier Volumes for Neonatal Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Table 21.

Individual SST Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Table 22.

Overall SST Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Table 23.

EST Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Table 24.

EST Test Step Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Table 25.

Overall EST Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Table 26.

Gestures and Their Meanings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Table 27.

Allowable Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Table 28.

Setting Up a Patient for NIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Table 29.

Invasive to NIV on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Table 30.

NIV to Invasive on Same Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Table 31.

MISCA Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Table 32.

MISCF Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Table 33.

Alarm Descriptions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Table 34.

Alarm Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Table 35.

Technical Alarm Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Table 36.

Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Table 37.

Non-technical Alarm Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Table 38.

Non-Technical Alarms and Suggested Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Table 39.

Operator Preventive Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Table 40.

Surface Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Table 41.

Component Cleaning Agents and Disinfection Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Table 42.

Sterilization Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Table 43.

Component Sterilization Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Table 44.

Service Preventive Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Table 45.

Accessories and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

Table 46.

Compliance Volume Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

Table 47.

Pressure Adjustment Limits According to Patient Body Weight (PBW) . . . . . . . . . . . . . . . . . . . . . . . . . 209

Table 48.

Spontaneous Breath Delivery Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Table 49.

Pressure Adjustment Limits According to Patient Body Weight (PBW) . . . . . . . . . . . . . . . . . . . . . . . . . 212

Table 50.

Inspiratory and Expiratory Pause Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Table 51.

Values for V

Based on Circuit Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

Table 52.

Peak Flow and Circuit Type (Leak Sync Disabled) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

Table 53.

Modes and Breath Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

Table 54.

Safety PCV Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

Table 55.

Inspiratory Backup Ventilation Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241

Table 56.

Performance Verification Equipment Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

Table 57.

Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

Table 58.

Pneumatic Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

Table 59.

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

Table 60.

Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

Table 61.

Interface Pin Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

Table 62.

Nurse Call Pin Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

Table 63.

Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

Table 64.

Ventilator Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

Table 65.

Alarm Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

Table 66.

Patient Data Range and Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

Table 67.

Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

Table 68.

Monitoring (Patient Data) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

Table 69.

Computed Value Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

Table 70.

Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264

Table 71.

Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264

Table 72.

Immunity to Proximity Fields RF Wireless Communications Equipment . . . . . . . . . . . . . . . . . . . . . . . . 267

Table 73.

AIM Standard Test Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268

Table 74.

Table 75.

Table 76.

Maximum Leak Compensation Flow Based on Patient Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

Table 77.

SENS

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

Table 78.

Absolute limits for PAV+™ Monitored Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287

Table 79.

PAV+™ Work of Breathing Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289

Table 80.

Default PBW-based Resistance Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294

Table 81.

Table 82.

Allowable NeoMode Ventilator Settings and Ventilation Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298

Table 83.

Humidifier Volumes - Neonatal Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299

Table 84.

Delivered Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301

Table 85.

Monitored Inspired Volume (VTI) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301

Table 86.

Monitored Exhaled Tidal Volume (V

) Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301

Table 87.

Proximal Flow Option Data Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306

Table 88.

Proximal Flow Option SST test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308

Table 89.

Proximal Flow Sensor Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

Table 90.

Proximal Flow Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

Table 91.

Proximal Flow Option and Component Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

Table 92.

Trended Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316

Table 93.

Trended Patient Data Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317

Table 94.

Sampling Periods for Selected Time Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319

Table 95.

Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

1 Introduction

1.1 Overview

This manual contains information for operating the Puritan Bennett 980 Series Ventilators. Before operating the ventilator system, thoroughly read this manual.

To obtain an additional copy of this manual, contact Covidien Customer Service or your local representative.

1.1.1 Related Documents

Covidien makes available all appropriate information relevant to use and service of the ventilator. For further assistance, contact your local Covidien representative.

• The Puritan Bennett 980 Series Ventilator Operator’s Manual —Provides basic information on operating the ventilator and troubleshooting errors or malfunctions. Before using the ventilator, thoroughly read this manual.

• The Puritan Bennett 980 Series Ventilator Service Manual —Provides information to Covidien-trained service technicians for use when testing, troubleshooting, repairing, and upgrading the ventilator.

This chapter contains the following:

• Symbol definitions

• Safety Information, including warnings, cautions, and notes

• Technical assistance information

• How to access on-screen help

• How to access warranty information

• Serial number interpretation

• Information regarding electromagnetic susceptibility

1.2 Global Symbol Definitions

Table 1

describes the symbols shown on the ventilator shipping cartons. Other symbols appearing on various labels are shown in

Chapter 2

Table 1.

Shipping Carton Symbols and Descriptions

Symbol Description

CE Mark 0123: Signifies compliance with Medical Device Directive 93/42/EEC

Serial number

Part number

Authorized representative

Manufacturer

This side up

Fragile

Table 1.

Shipping Carton Symbols and Descriptions (continued)

Symbol Description

Humidity limitations: 10% to 95% relative humidity, non-condensing (operation and storage)

Temperature limitations: 10°C to 40°C (50°F to 104°F) (operation) –20°C to 70°C (–4°F to

158°F) (storage)

Atmospheric pressure limitations: 70 kPa to 106 kPa (10.2 psi to 15.4 psi)

Keep dry

CSA certification mark that signifies the product has been evaluated to the applicable

ANSI/Underwriters Laboratories Inc. (UL) and CSA standards for use in the US and Canada.

This device is for sale by or on the order of a physician.

Refer to instruction manual.

1.3 Safety Information

Please pay close attention to warnings and their associated consequences, which could result in adverse events.

Adverse Events (Residual Risks):

Adverse events associated with the use of the PB980 ventilator in order of least to most clinically severe are: anxiety, delay of treatment, cross patient exposure to body fluids, oxygen saturation high, oxygen toxicity, bronchospasm, tissue damage/tissue trauma, hyperventilation, hypoventilation, thermal injury, electric shock, lung overinflation, infection, oxygen saturation low, hypoxia, barotrauma, respiratory failure, extubate (unplanned), cardiac arrest, asphyxia. Any serious incident that occurs in relation to the device (or its accessories where applicable) should be reported to Medtronic and to the national competent authority. The most frequent events are delay of treatment due to transfer to another ventilator (without harm), anxiety, and oxygen saturation low (recoverable without harm). The remaining harms are infrequent or rare.

1.3.1 Safety Term Definitions

This section contains safety information for users, who should always exercise appropriate caution while using the ventilator.

Table 2.

Safety Term Definitions

Term

WARNING

Caution

Note

Definition

WARNING

Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment.

Caution

Cautions alert users to exercise appropriate care for safe and effective use of the product.

Note

Notes provide additional guidelines or information.

1.3.2 Warnings Regarding Fire Hazards

Warning: Explosion hazard—Do not use in the presence of flammable gases. An oxygen-rich environment accelerates combustibility.

Warning: To avoid a fire hazard, keep all components of the system away from all sources of ignition (such as matches, lighted cigarettes, flammable medical gases, or heaters). Oxygen-rich environments accelerate combustibility.

Warning: In case of fire or a burning smell, immediately take these actions if it is safe to do so: disconnect the patient from the ventilator and disconnect the ventilator from the oxygen supply, facility power, and all batteries.

Provide alternate method of ventilatory support to the patient, if required.

Warning: Replacement of ventilator batteries by inadequately trained personnel could result in an unacceptable risk, such as excessive temperatures, fire, or explosion.

Warning: To minimize fire hazard, inspect and clean or replace, as necessary, any damaged ventilator parts that come into contact with oxygen.

Warning: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system.

1.3.3 General Warnings

Warning: To ensure proper operation and avoid the possibility of physical injury, only qualified medical personnel should attempt to set up the ventilator and administer treatment with the ventilator.

Warning: In case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death. An alternative source of ventilation, such as a self-inflating, manually-powered resuscitator (as specified in ISO 10651-4 with mask) should always be available when using the ventilator.

Warning: Patients on mechanical ventilation should be monitored by clinicians for proper patient ventilation.

Warning: The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of conditions. For a detailed understanding of ventilator operations, be sure to thoroughly read this manual before attempting to use the ventilator system.

Warning: To prevent patient injury, do not use the ventilator if it has a known malfunction. Never attempt to override serious malfunctions. Replace the ventilator and have the faulty unit repaired by trained service personnel.

Warning: To prevent patient injury, do not make unauthorized modifications to the ventilator.

Warning: To prevent injury and avoid interfering with ventilator operation, do not insert tools or any other objects into any ventilator openings.

Warning: The audio alarm volume level is adjustable. The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels. See

Section 3.8.2.6, Alarm Volume, page 81

for instructions on alarm volume adjustment.

Warning: Do not silence, disable, or decrease the volume of the ventilator’s audible alarm if patient safety could be compromised.

Warning: If increased pressures are observed during ventilation, it may indicate a problem with the ventilator.

Check for blocked airway, circuit occlusion, and run SST.

Warning: The LCD panel contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances.

Warning: If the graphical user interface (GUI) display/LCD panel is blank or experiences interference and cannot be read, check the patient, then verify via the status display that ventilation is continuing as set. Because breath delivery is controlled independently from the GUI, problems with the display will not, by themselves, affect

ventilation. The ventilator, however, should be replaced as soon as possible and repaired by Covidien-trained service technicians.

Warning: The Puritan Bennett 980 Series Ventilator contains phthalates. When used as indicated, very limited exposure to trace amounts of phthalates may occur. There is no clear clinical evidence that this degree of exposure increases clinical risk. However, to minimize risk of phthalate exposure in children and nursing or pregnant women, this product should only be used as directed.

Warning:

Even though the 980 Series Ventilator meets the standards listed in Chapter 11

, the internal lithium-ion battery of the device is considered to be Dangerous Goods (DG) Class 9 - Miscellaneous, when transported in commerce. The 980 Series Ventilator and the associated lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA: International Air Transport Association),

International Maritime Dangerous Goods code for sea and the European Agreement concerning the International

Carriage of Dangerous Goods by Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements may apply.

1.3.4 Warnings Regarding Environment of Use

Warning: Do not position the ventilator next to anything that blocks or restricts the gas inlet or cooling air circulation openings, gas exhaust port, fan intake, or alarm speaker, as this may:

• limit the air circulation around the ventilator, potentially causing overheating

• limit the ventilator’s ability to exhaust patient exhaled gas leading to potential harm

• limit the clinician’s ability to hear ventilator alarms

Warning: To avoid injury, do not position the ventilator in a way that makes it difficult to disconnect the patient.

Warning: To ensure proper operation, do not position the ventilator in a way that makes it difficult to access the

AC power cord.

Warning: Do not use the ventilator in a hyperbaric chamber. It has not been validated for use in this environment.

Warning: Do not use the ventilator in the presence of strong magnetic fields. Doing so could cause a ventilator malfunction.

Warning: Do not use the ventilator during radiotherapy (i.e. cancer treatment using ionizing radiation), as doing so could cause a ventilator malfunction.

Warning: To avoid the risk of ventilator malfunction, operate the ventilator in an environment that meets

specifications. See Table 63, page 247

Warning: Do not use the ventilator as an EMS transport ventilator. It has not been approved or validated for this use.

1.3.5 Warnings Before Using Equipment

Warning: Before activating any part of the ventilator, be sure to check the equipment for proper operation and,

if appropriate, run SST as described in this manual. See Section 3.9.1.2, SST Test Sequence, page 85

Warning: Check for leaks in the ventilator breathing system by running SST prior to ventilating a patient.

Warning: Lock the ventilator’s casters during use to avoid the possibility of extubation due to inadvertent ventilator movement.

Warning:

The ventilator accuracies listed in Table 64 ,

Table 65 , and

Table 66

are applicable under specified

operating conditions. See Table 63, page 247

. If the ventilator is operated outside specified ranges, the ventilator may supply incorrect information and the accuracies listed in the aforementioned tables do not apply. A hospital biomedical technician must verify the ventilator is operated in the environmental conditions specified.

1.3.6 Warnings Regarding Electrical Power

Warning: To avoid the risk of electrical shock:

• Use only Covidien batteries, adapters, and cables.

• Do not use batteries, adapters or cables with visible signs of damage.

• Do not touch internal components.

1.3.7 Warnings Regarding Ventilator Settings

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient, based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

Warning: Avoid nuisance alarms by applying appropriate alarm settings.

Warning: To prevent inappropriate ventilation, select the correct tube type (ET or tracheostomy) and tube inner diameter (ID) for the patient’s ventilatory needs. Inappropriate ventilatory support leading to over-or under-ventilation could result if an ET tube or trach tube setting larger or smaller than the actual value is entered.

Warning: Setting expiratory volume alarms to OFF increases the risk of not detecting a low returned volume.

Warning: Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not to activate during ventilation, which reduces its efficacy for monitoring the patient and alerting the clinician to situations that may require intervention.

1.3.8 Warnings Regarding Hoses, Tubing, and Accessories

Warning: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system.

Warning: Adding accessories to or removing accessories from the ventilator breathing system (VBS) can change the pressure gradient and affect ventilator performance. Ensure that any changes to the ventilator circuit configurations do not exceed the specified values for circuit compliance and for inspiratory or expiratory limb total

resistance. See Table 59, page 244

. If adding accessories to or removing accessories from the VBS, always run SST to establish circuit compliance and resistance prior to ventilating the patient.

Warning: Use of a nebulizer or humidifier can lead to an increase in the resistance of inspiratory and exhalation filters. Monitor the filters frequently for increased resistance or blockage.

Warning: During transport, the use of breathing tubing without the appropriate cuffed connectors may result in the circuit becoming detached from the ventilator.

Warning: The added gas from an external pneumatic nebulizer can adversely affect spirometry, delivered O lead to an increase in exhalation filter resistance.

%, delivered tidal volumes, and breath triggering. Additionally, aerosolized particulates in the ventilator circuit can

Warning: Carefully route patient tubing and cabling to reduce the possibility of patient entanglement or strangulation.

Warning: Always use filters designed for use with the Puritan Bennett 980 Series Ventilator. Do not use filters designed for use with other ventilators. See

Table 45 for relevant filter part numbers.

Warning: To avoid liquid entering the ventilator, empty the expiratory condensate vial before fluid reaches the maximum fill line.

Warning: Accessory equipment connected to the analog and digital interfaces must be certified according to IEC

60601-1. Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input part or signal output part of the ventilator system configures a

medical system, and is therefore responsible for ensuring the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult Medtronic Technical Services at 1 800.255 6774 or your local representative.

Warning: Do not use HMEs (heat and moisture exchangers) and heated humidifiers together. This may result in the HME absorbing water and becoming obstructed, resulting in high airway pressures.

1.3.9 Warnings Regarding Gas Sources

Warning: Do not use nitric oxide, helium or mixtures containing helium as high-pressure inlet gas sources with the ventilator. They have not been validated for use as primary gas sources and could result in compromised ventilation and monitoring.

Warning: To avoid the risk of ventilator malfunction, do not use the ventilator with anesthetic gases.

Warning: For proper ventilator operation, use only clean, dry, medical grade gases when ventilating a patient.

Warning: Use of only one gas source could lead to loss of ventilation or hypoxemia if that one gas source fails and is not available. Therefore, always connect at least two gas sources to the ventilator to ensure a constant gas supply is available to the patient in case one of the gas sources fails. The ventilator has two connections for gas sources: air inlet and oxygen inlet.

Warning: Use of the ventilator in altitudes higher or barometric pressures lower than those specified could compromise ventilator operation. See

Table 63, page 247

for a complete list of environmental specifications.

Warning: The ventilator should be connected to a gas pipeline system compliant to ISO 7396-1:2007 because:

• Installation of the ventilator on a non-ISO 7396-1:2007 compliant gas pipeline system may exceed the pipeline design flow capacity.

• The ventilator is a high-flow device and can interfere with the operation of other equipment using the same gas source if the gas pipeline system is not compliant to ISO 7396-1:2007 .

1.3.10 Warnings Regarding Infection Control

Warning: Patients receiving mechanical ventilation may experience increased vulnerability to the risk of infection. Dirty or contaminated equipment is a potential source of infection. It is recognized that cleaning, sterilization, sanitation, and disinfection practices vary widely among health care institutions. Always follow your hospital infection control guidelines for handling infectious material. Follow the instructions in this manual and your institution’s protocol for cleaning and sterilizing the ventilator and its components. Use all cleaning solutions and products with caution. Follow manufacturer’s instructions for individual cleaning solutions. See

Chapter 7 .

Warning: To prevent infection and contamination, always ensure inspiratory and exhalation bacteria filters are installed before ventilating the patient.

Warning: Never attempt to re-use single patient use components or accessories. Doing so increases risk of cross-contamination and reprocessing of single patient use components or accessories may compromise functionality leading to possible loss of ventilation.

1.3.11 Warnings Regarding Ventilator Maintenance

Warning: To ensure proper operation and avoid the possibility of physical injury, this ventilator should only be serviced by qualified technicians who have received appropriate Medtronic-provided training for the maintenance of this ventilator.

Warning: Follow preventive maintenance according to specified intervals. See

Table 39 and

Table 44

1.3.12 Cautions

Caution: To prevent possible equipment damage, ensure the casters are locked to prevent inadvertent movement of the ventilator during routine maintenance, or when the ventilator is on an incline.

Caution: Do not use sharp objects to make selections on the display or keyboard.

Caution: To ensure optimal performance, keep the GUI touch screen and keyboard clean and free from foreign

substances. See Table 40, page 172 .

Caution: To avoid moisture entering the ventilator and possibly causing a malfunction, Covidien recommends using a wall air water trap when using piped medical air from a facility-based air compressor.

Caution: Use only the cleaning agents specified. See

Table 40, page 172

for approved cleaning agents.

Caution:

Clean compressor inlet filter according to the interval listed in Chapter 7 . See Table 39 .

Caution: Do not block cooling vents.

Caution: Ensure proper connection and engagement of exhalation and inspiratory filters.

Caution: Follow instructions for proper GUI and BDU (breath delivery unit) mounting as described in the

Puritan Bennett 980 Series Ventilator Installation Instructions .

Caution: Follow proper battery installation instructions as described in this manual.

Caution: When transferring the ventilator from storage conditions, allow its temperature to stabilize at ambient conditions prior to use.

Caution: Remove extended and primary batteries from ventilator prior to transporting in a vehicle. Failure to do so could result in damage to the ventilator.

1.3.13 Notes

Note: When using Non-Invasive Ventilation (NIV), the patient’s actual exhaled volume may differ from the exhaled volume reported by the ventilator due to leaks around the noninvasive interface.

Note: When utilizing a closed-suction catheter system, the suctioning procedure can be executed using existing mode, breath type, and settings. To reduce potential for hypoxemia during the procedure, elevated delivered oxygen can be enabled using the Elevate O

control. See

Section 3.8.2.5, Elevate O

, page 80 .

1.4 Obtaining Technical Assistance

1.4.1 Technical Services

For technical information and assistance, to order parts, or to order an operator’s manual or service manual,

contact Covidien Technical Services at 1 800 255 6774 or a local Covidien representative. See Table 3 for service

centers in the USA and other countries. The Puritan Bennett 980 Series Ventilator Service Manual includes information necessary to service or repair the ventilator when used by Covidien-trained service technicians.

If unable to correct a problem while using the ventilator, contact Covidien Technical Services at 1 800 255 6774 or a local Covidien representative. The Service manual, used by Covidien-trained service technicians, provides additional troubleshooting information.

When calling Covidien Technical Services, or a local Covidien representative, have the BDU and GUI serial numbers available, as well as the firmware version number of the ventilator system.

The ventilator’s configuration is available by touching the wrench icon on the GUI screen. Have this information available whenever requesting technical assistance.

See

Table 3

for service centers in the USA and other countries.

Table 3.

Covidien US and International Service Centers, by Region

Covidien Argentina

Aguero 351 Capital Fed‐ eral - 1171 ABC, Argentina

Covidien Asia Covidien Australia

Covidien Austria GmbH

Campus21

Table 3.

Covidien US and International Service Centers, by Region (continued)

Tel: (5411) 4863-5300

Fax: (5411) 4863-4142

Covidien Belgium

BVBA/SPRL.

Generaal De Wittelaan 9/5

2800 Mechelen Belgium

Tel +32 15 29 44 50

Fax +32 15 29 44 55

Covidien China

2F, Tyco Plaza 99 Tian Zhou

Rd Shang Hai 200233 P.R.

China

Tel: (+86) 4008 1886 86

Fax: (+86) 2154 4511 18

Covidien Danmark A/S

Langebrogade 6E, 4. th

DK-1411 København K

Danmark

Tel +45 4368 2171

Fax:+45 4368 4511 18

Covidien France SAS

2 Rue Denis Diderot 78990

Elancourt France

Tel +33 (0) 13079 8000

Fax +33 (0) 130 79 8030

Covidien Ireland

Block G, Ground Floor,

Cherrywood Business

Park, Loughlinstown

County Dublin, Ireland

Tel +353 (0) 1.4073173

Fax +353(0) 1.4073174

Covidien Korea

5F, Hibrand Living Gwan,

#215, Yangjae-Dong, Seo‐ cho-Gu Seoul, Korea

Tel: +822 570 5459

Fax: +822 570 5499

Singapore Regional Serv‐ ice Centre 15 Pioneer Hub,

#06-04 Singapore 627753

Tel (65) 6578 5288

Fax (65) 6515 5260

Covidien Brazil

Av. Das Nações Undias

12995 Andar 23 - Brooklin

São Paulo, SP Brasil

04578-000

Tel: (5511) 2187-6200

Fax: (5511) 2187-6380

Covidien Colombia

Edificio Prados de la Morea

Carretera Central Del

Norte (Cra 7a)Kilometro

18, Chia-Cundinamarca

Bogota, Colombia

Tel: (571) 619-5469

Fax: (571) 619-5425

Covidien Deutschland

GmbH

Gewerbepark 1r D-93333

Neustadt/Donau Ger‐ many

Tel + 49 (0) 9445 95 9 0

Fax + 49 (0) 9445 95 9 155

Covidien Hong Kong

Unit 12 - 16, 18/F BEA

Tower Millennium City

54187 Kwun Tong Road

Kwum Tong, Kowloon,

Hong Kong

Tel + 852 3157 7299

Fax + 852 2838 0749

Covidien Israel

5, Shasham St. North

Industrial Park POB3069

Caesarea, 38900

Tel +972 4.627 73 88

Fax+972 4.627 76 88

Covidien Mexico

Insurgentes Sur # 863, Piso

16 Col. Nápoles Del. Benito

Juarez Mexico, D.F. 03810

Mexico

Tel: (5255) 5804-1524

Fax: (5255) 5536-1326

52A Huntingwood Drive

Huntingwood, NSW 2148

Australia

Tel: (+61) 1800 - 350702

Fax: (+61) 2967 - 18118

Covidien Canada

19600 Clark Graham Baie d’Urfe, QC, H9X 3R8 Can‐ ada

Tel:1-514-695-1220, Select

Option 2

Fax: 1-514-695-4965

Covidien Costa Rica

Global Park, Parkway 50 La

Auroa de Heredia Costa

Rica

Tel: (506) 2239 - 5386

Fax: (506) 2239 - 5319

Covidien ECE

Galvahiho 7 / A 832104

Bratislava Slovakia

Tel +420 2 41 095 735

Fax +420 2 39 000 437

Covidien India

10th Floor Building No 9B

DLF Cyber City Phase III

Gurgaon Haryana -

122002 India

Tel + 91 1244 709800

Fax + 91 1244 206850

Covidien Italia S.p.A

Via Rivoltana 2/D I-20090

Segrate (Mi) Italy

Tel +39 02 703 173 1

Fax +39 02 71740584

Covidien Nederland BV

Hogeweg 105 NL5301 LL

ZaltbommelNederland

Tel: 0418 57 66 00

Fax 0418 57 67 91

Europaring F09402 Brunn am Gebrige A-2345 Öster‐ reich

Tel: (+43) 2236 - 3788 39

Fax: (+43) 2236 - 3788 3940

Covidien Chile

Camino lo Boza (Ex 8395)

Pudehuel Santiago Chile

Tel: (562) 739 - 3000

Fax: (562) 783 - 3149

Covidien ECE

Prosecká 851/64 190 00

Prague Czech Republic

Tel +42 024 109 57 35

Fax + 42 02 3900 0437

Covidien Finland Oy

Pursimiehenkatu 26-39C

PL407 FIN-00151 Helsinki

Finland

Te. +358 9725 192 88

Fax +358 9725 192 89

Covidien ECE

Mariássy u.7. 1095 Buda‐ pest Hungary

Tel + 36 1880 7975

Fax + 36 1777 4932

Covidien Japan Inc.

Technical Support Center

83-1, Takashimadaira

1-Chome Itabashi-ku,

Tokyo 175-0082 Japan

Tel: +81 (0) 3 6859 0120

Fax: +81 (0) 3 6859 0142

Covidien New Zealand

Cnr Manu Tapu Dr &

Joseph Hammond Pl.

Auckland Airport New

Zealand

Phone: + 64 508 489 264

Table 3.

Covidien US and International Service Centers, by Region (continued)

Covidien Norge AS

Bankveinen 1, Postboks

343 N-1372 Askerr Norway

Tel +47 2415 98 87

Fax +47 2415 15 98 88

Covidien Puerto Rico

Palmas Industrial Park

Road 869 km 2.0 Bdlg. #1

Cataño, PR 00962

Tel. 787-993-7250 Ext.

7222 & 7221

Fax 787-993-7234

Covidien Spain S.L.

c/Fructuós Gelabert 6, 8

Planta 08970 Sant Joan‐

Despí Barcelona, Spain

Tel +34 93475 86 10

Fax +34 93 477 10 17 a

Covidien Panama

Parque Industrial Costa del

Esta Calle Primera, Edifio #

109 Panama City, Panama

Tel: (507) 264-7337

Fax: (507) 236-7408

Covidien Russia

53 bld. 5 Dubininskaya

StreetMoscow RUSSIA.

119054

Tel +70 495 933 64 69

Fax +70 495 933 64 68

Covidien Sverige AB

Hemvärnsgatan 9, Box 54

SE-171 74 Solna Sweden

Tel +46(0)8517 615 73

Fax + 46 (0)8 517 615 79

Covidien Polska

Al. Jerozolimskie 162

02-342 Warszawa. Polska

Tel +48 22 312 20 00

Fax +48 22 312 20 20

Covidien Saglik A.S.

Maslak Mahallesi Bilim

Sokak No: 5, Sun Plaza Kat:

2-3 Sisli, Istanbul 34398

Turkey

Tel +90 212 366 20 00

Fax +90 212 276 35 25

Covidien Switzerland

Roosstrasse 53 Ch-8832

Wollerau Switzerland

Tel +41(0)44 786 50 50

Fax +41 (0) 44 78650 10

Covidien Portugal Lda.

Produtos De Saúde Ida.

Est: Outeiro Polima, Lote

10-1° Piso Abóboda

P-2785-521 S. Domingos de Rana Portugal

Tel +351 21 448 10 00

Fax +351 21 445 05 88

Covidien South Africa

Corporate Park North 379

Roan Crescent Randjes‐ parkMidrand, South Africa

Tel +27 115 429 500

Fax +27 115 429 624

Covidien Thailand

319 Chamchuri Square

17th Floor, Unit 1-8, Phaya‐ thai Road Pathumwan,

Bangkok 10330, Thailand

Tel +66-2 207-3 100

Fax +66-2 207 - 3101

Covidien UK

4500 Parkway Whiteley,

Fareham Hampshire

PO157NY, United King‐ dom

Tel +44 (0) 1329 2240002

Fax +44 (0) 1329 220213

Covidien USA

2101 Faraday Ave Carls‐ bad, CA 92008

Phone: 1-800-255-6774

(option 4

Email:

[email protected]

For online Technical support, visit the SolvIT SM Center Knowledge Base at www.covidien.com.

The SolvIT Center provides answers to frequently asked questions about the ventilator system and other Puritan Bennett products 24 hours a day, 7 days a week.

1.4.2 On-Screen Help

The ventilator is equipped with an on-screen help system that enables users to select an item on the screen and display a description of that item. Follow the procedure to access and use on-screen help.

1.4.2.1 Accessing On-screen Help Topics

Help topics on the ventilator are called tooltips. If a tooltip is available, a glowing blue outline appears around the item in question.

To access tooltips

1. Touch the item in question for a period of at least 0.5 seconds, or drag the help icon (the question mark icon appearing at the lower right of the GUI screen) to the item in question.

A tooltip appears with a short description of the item. Most screen items have tooltips associated with them, providing the operator with access to a multitude of help topics.

2. Touch “more” on the dialog to display an expanded description.

3. Touch “close” to close the dialog, or let it fade away after 5 seconds

Notes:

• Dragging the help icon causes the tooltip to display in its unexpanded state.

• Dragging the help icon and pausing causes a tooltip to display. Continue dragging to another item to dismiss the last tooltip and display another tooltip.

1.4.2.2 Other Resources

Additional resources for information about the ventilator can be found in the Puritan Bennett 980 Series

Ventilator Service Manual and appendices in this manual for BiLevel 2.0, Leak Sync, PAV+™, NeoMode 2.0, and

Proximal Flow and Trending functions.

1.5 Warranty Information

To obtain warranty information, for a covered product, contact Medtronic Technical Services at 1 800 255 6774 or call a local Medtronic representative.

1.6 Manufacture Date

The graphical user interface (GUI) and breath delivery unit (BDU) each possess a specific year of manufacture applicable only for that assembly. These dates are contained in the serial numbers for each assembly or option. Serial numbers for the 980 Ventilator final units consist of ten digits, in the following format:

35ZYYXXXXX where

• 35 signifies the unit was manufactured in Galway, Ireland

• Z represents the product code (B= breath delivery unit, G= GUI, C = Compressor, P= Proximal Flow monitoring option. The product codes shown here are typically the most common. There may be other product codes shown in the serial number depending upon the particular options purchased.

• YY is a two-digit year code that changes with each year

• XXXXX is a sequential number that resets at the beginning of each new year

Serial numbers are located on labels on the back panels of the GUI and BDU, and in various locations on product options.

1.7 Manufacturer

Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.

Covidien Ireland Limited, IDA Business &Technology Park, Tullamore, Ireland.

1.8 Electromagnetic Compatibility

The ventilator system complies with the requirements of IEC 60601-1-2:2007, IEC 60601-1-2: 2014 (EMC Collateral

Standard), and AIM Standard 7351731 Rev 2.00.2017. Certain transmitting devices (cellular phones, walkie-talkies, cordless phones, paging transmitters, RFID devices, etc.) emit radio frequencies that could interrupt ventilator

1 operation if operated in a range too close to the ventilator. Practitioners should be aware of possible radio frequency interference if portable devices are operated in close proximity to the ventilator.

The Puritan Bennett 980 Series ventilator requires special precautions to be taken regarding electromagnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in

Chapter 11 .

2 Product Overview

2.1 Overview

This chapter contains introductory information for the Puritan Bennett 980 Series Ventilator.

Notes:

• Items shown in bold font are contained as entries in the glossary

• Items shown in bold font are physical hardware features (e.g., to patient port, exhaust port)

• Alarms are shown in ALL CAPITAL letters

Communication between the ventilator’s graphical user interface (GUI and the breath delivery unit (BDU) occurs continuously via independent central processing units (CPUs) .

See

Figure 12, page 54 and its associated reference designators when reading the following paragraphs.

Gas delivery starts with the ventilator connected to wall (or bottled) air and oxygen. Gas travels to the mix module where gas pressures are regulated by their respective proportional solenoid valves (PSOLs) . The PSOLs meter the gases according to the ventilator settings entered, then the gases flow through individual air and oxygen flow sensors into the mix manifold and accumulator for mixing. The individual gas pressures are continuously monitored both before and after they are mixed in the mix manifold and accumulator assemblies. The mixed gas then flows to the inspiratory pneumatic system where it flows through the breath delivery flow sensor and then the inspiratory PSOL for delivery to the patient.

Before the gas reaches the patient, it passes through an internal inspiratory bacteria filter, then through an external inspiratory bacteria filter attached to the ventilator’s gas outlet (the to patient port) where the breathing circuit is attached. When the gas returns from the patient, it flows through the expiratory limb of the breathing circuit, to the from patient port on the exhalation bacteria filter (which includes a condensate vial) before flowing through the exhalation flow sensor and exhalation valve (EV) . A gas exhaust port allows exhaled gas to exit the ventilator and flow to the room.

The ventilator recognizes the patient’s breathing effort using pressure triggering (P-Trig) or flow triggering

( ⩒ -Trig) . During pressure triggering, as the patient inhales, the airway pressure decreases and the inspiratory pressure transducer (PI) monitors this pressure decrease. When the pressure drops to at least the value of the pressure sensitivity (P

SENS

) setting, the ventilator delivers a breath. During flow triggering, the difference between inspiratory and expiratory flows is monitored. As the patient inhales, the exhalation flow sensor measures less flow, while the delivery flow sensor measurement remains constant. When the difference between the two measurements is at least the value of the operator-set flow sensitivity ( ⩒

SENS

) , the ventilator delivers a breath. If the patient is not inhaling, any difference between delivered flow and expiratory flow is due to flow sensor inaccuracy or leaks in the ventilator breathing circuit. To compensate for leaks, which can cause autotriggering, the clinician can increase the ⩒

SENS

setting or enable Leak Sync, if available.

Note: Leak Sync is a software function that is enabled by the clinician. Details on its operation are provided in

Chapter 13 .

A backup pressure triggering threshold of 2 cmH

O is also in effect. This provides enough pressure sensitivity to avoid autotriggering, but will still allow the ventilator to trigger with acceptable patient effort.

The exhalation valve controls positive end expiratory pressure (PEEP) using feedback from the expiratory pressure transducer (PE) . the valve controller also cycles the ventilator into the expiratory phase if the PE measurement equals or exceeds the operator-set high circuit pressure limit. The PE measurement also controls when the safety valve (SV) opens. If PE measures 110 cmH

O or more in the ventilator breathing circuit, the safety valve opens, allowing the patient to breathe room air through the valve.

2.2 Ventilator Description

The ventilator system is available in three models. All ventilators provide continuous ventilation to patients requiring respiratory support.

• Puritan Bennett 980 Pediatric–Adult Ventilator - The Pediatric–Adult model ventilates pediatric or adult patients with predicted body weights from 3.5 kg to 150 kg, and with tidal volumes from 25 mL to 2500 mL.

• Puritan Bennett 980 Neonatal Ventilator - The Neonatal model ventilates neonatal patients with predicted body weights from 0.3 kg to 7.0 kg, and with tidal volumes for mandatory volume-controlled breaths from 2 mL to 315 mL.

• Puritan Bennett 980 Universal Ventilator - The Universal model ventilates neonatal, pediatric, and adult patients with predicted body weights from 0.3 kg to 150 kg, and with tidal volumes for mandatory volume-controlled breaths from 2 mL to 2500 mL.

To ventilate neonatal patients on the Pediatric–Adult or Universal models, the NeoMode 2.0 software option is required. For details regarding the NeoMode 2.0 software option, see

Chapter 15 .

The ventilator should have a service life of approximately 10 years, provided the preventive maintenance schedule stated in the Puritan Bennett 980 Series Ventilator Service Manual is followed.

The ventilator’s IEC 60601-1/EN 60601-1 classification is:

• Protection class I

• Type BF

• Mobile

• Internally powered

• IP 21 equipment

• Continuous operation

• Not suitable for use with flammable medical gases (not AP or APG)

See

Table 5, page 30

for a description of the meaning of the IP classification.

The ventilator system uses a graphical user interface (GUI) and breath delivery unit (BDU) for entering patient settings and delivering breaths to the patient. The GUI contains electronics capable of transferring the clinician’s input (by touching the screen) to the BDU where pneumatic and electronic systems generate the breathing parameters.

2.3 Indications For Use/Intended Purpose

The Puritan Bennett 980 Ventilator System is designed for use on patient population sizes from neonatal (NICU) through adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).

It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or noninvasively, to patients who require the following types of ventilator support:

• Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs)

• Assist/ Control, SIMV or Spontaneous modes of ventilation

Note: Intended typical usage may be defined to include the following usage for the ventilator system

Hospital Use – Typically covers areas such as operating rooms, special procedure areas, intensive and critical care areas within the hospital. Hospital-type facilities include skilled nursing facilities, surgicenters, and sub-acute centers.

Intra-hospital transport – Includes transport of a patient within the hospital or hospital-type facility. All external hospital transportation (i.e. ambulance or aircraft) is excluded.

2.4 Contraindications

Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.

2.5 Components List

Note: The ventilator has no components made of natural rubber latex.

Note: The components in the gas pathway that can become contaminated with bodily fluids or expired gases during both normal and single fault conditions are:

• External inspiratory filter

• Internal inspiratory filter

• Exhalation filter and condensate vial

• Exhalation valve assembly

The typical ventilator system ships with the following packing list. Depending upon the ventilator system purchased, your list may vary.

Quantity

Table 4.

Typical Packing List

Item

Graphical user interface

Breath delivery unit

Inspiratory filter

Exhalation filter

Condensate vial

Gas hoses (air and oxygen)

Standard caster base

Power cord

Operator’s manual CD

Puritan Bennett 980 Series Ventilator Installation Instructions

Flex arm

Drain bag

Gold standard circuit (for running EST)

2.6 Product Views

2.6.1 GUI Front View

Figure 1.

GUI Front View

1 Display brightness key

2 Display lock key

3 Alarm volume key

4 Manual Inspiration key

5 Rotary encoder (knob)

6 Inspiratory pause key

7 Expiratory pause key

8 Alarm reset key

9 Audio paused key

10 Omni-directional LED

2.6.2 GUI Rear View

Figure 2.

GUI Rear View

See

Table 7, page 33

for symbols found on the GUI or BDU. The “Do Not Push” symbol found on the GUI, only, is shown in this table.

2.6.3 BDU Front View

Figure 3.

BDU Front View

1 Condensate vial

2 Exhalation filter

3 Exhalation filter latch

4 AC power indicator

5 Power switch

6 Status display

7 Internal inspiratory filter

8 Option connector panel door

Table 5.

BDU Front Label Symbols and Descriptions

Symbol

To patient port

From patient port

Description

Exhalation filter latch locked (down)/unlocked (up)

2.6.4 BDU Rear View

Figure 4.

BDU Rear View

1 Standard base

2 Air inlet

3 Oxygen inlet

4 Labels indicating installed software options

5 Service mode button

6 Remote alarm port

7 Cylinder mount (optional)

Software option labels are applied to the grid located on the back of the ventilator, as shown in Figure 5 and in

Figure 4

, (item 4).

Figure 5.

Installed Software Options

Table 6

lists the symbols and descriptions found on BDU or base labels.

Table 6.

BDU Rear Label or Panel Symbols and Descriptions

Symbol Description

This device is for sale by or on the order of a physician.

User must consult instructions for use. Symbol is also found on “Do not obstruct” labels on both left and right sides of the ventilator, and on label indication supply gas connec‐ tions.

Keep away from fire or flame. Oxygen rich environments accelerate combustibility.

Atmospheric pressure limitations—The operational atmospheric pressure range 70 kPa to 106 kPa (10.2 psi to 15.4 psi).

Humidity limitations—The operational humidity limit range 10% to 95%.

Temperature limitations—The operational temperature limit range 50°F to 104°F (10°C to

40°C).

Type BF applied part.

IEC Ingress protection classification—Protected against ingress of fingers or similar objects and protected from condensation.

Explosive hazard. Do not use in the presence of flammable gases.

Table 6.

BDU Rear Label or Panel Symbols and Descriptions (continued)

Symbol Description

Authorized to bear the CSA certification mark signifying the product has been evaluated to the applicable ANSI/Underwriters Laboratories Inc. (UL) and CSA standards for use in the US and Canada.

The ventilator contains components manufactured with phthalates.

CB1

CB2

Potential equalization point (ground) (on AC panel).

BDU circuit breaker (on AC panel).

Compressor circuit breaker (on AC panel).

USB port (at rear of ventilator).

HDMI port (at rear of ventilator).

Service port (at rear of ventilator).

Service mode button (at rear of ventilator).

Remote alarm port (at rear of ventilator).

Ethernet connector (at rear of ventilator).

Serial port (at rear of ventilator).

Table 7.

Common Symbols Found on GUI or BDU Labels

Symbol Description

CE Mark—Signifies compliance with Medical Device Directive 93/42/EEC.

Do Not Push—Do not push on the GUI

Manufacturer—Name of the ventilator manufacturer.

Authorized representative.

Serial number.

Manufacture date—The manufacture date is contained in the serial number. See

Sec‐ tion 1.6, Manufacture Date, page 22 for details regarding interpretation of the serial num‐

ber.

WEEE—Proper waste disposal. Follow local governing ordinances regarding disposing of waste labeled with the WEEE symbol.

2.6.5 Ventilator Side Views

Figure 6.

Ventilator Right Side View

VEN_10308_B

Figure 7.

Ventilator Left Side View

VEN_10331_A

2.7 Mounting Configurations

The ventilator system can be mounted as a free-standing unit standing at the patient’s bedside; the BDU with the

GUI is mounted on a base with casters and includes a handle for ease of movement.

2.8 Battery Backup

The ventilator system uses a battery to provide backup power in case AC power is lost. When operating on battery

power, the status display shows the “On Battery Power” image. See Table 12, page 45 for a description of the status

display images and messages. An optional, extended battery is available to lengthen the amount of time the ventilator can operate on battery power. See

Section 3.3.2.2, Using Battery Power, page 55 .

2.9 Graphical User Interface

There are two displays on the ventilator — the primary display (GUI) and the status display.

2.9.1 Primary Display

The GUI incorporates a 15 inch display that rotates 170° about a vertical axis in either direction. The GUI can also be tilted up to 45° from vertical.

The clinician enters ventilation parameters via the GUI’s touch screen, also known as the ventilator’s primary display. The GUI’s keys activate other ventilator functions including screen brightness, display lock, alarm volume, manual inspiration, inspiratory pause, expiratory pause, alarm reset, and audio paused.

The GUI displays the following information depending on the state of the ventilator:

• Ventilator, apnea, and alarm settings

• Patient data

• Waveforms

• Current alarm banners

2.10 GUI Controls and Indicators

2.10.1 Control Keys

The GUI bezel has eight off-screen control keys as shown in

Table 8

Table 8.

GUI Control Keys

Key symbol Description

Brightness control key—Adjusts the GUI screen brightness. Press the key and turn the knob to adjust the brightness.

Display lock key—Actuates a lock to prevent inadvertent settings changes to the venti‐ lator (including the knob function) while the display is locked. The display lock is useful when cleaning the touch screen. Press the key again to unlock the display. Also use the

display lock key to reset the GUI touch screen as described in Section 2.10.2

Alarm volume key—Adjusts the alarm volume. The alarm volume cannot be turned off.

Manual inspiration key—In A/C, SIMV, and SPONT modes, delivers one manual breath to the patient in accordance with the current mandatory breath parameters. In BiLevel mode, transitions from low pressure (P

) to high pressure P

) (or vice versa). To avoid breath stacking, a manual inspiration is not delivered during inspiration or during the

restricted phase of exhalation. See Section 10.7.5, Manual Inspiration, page 209 for infor‐

mation on the restricted phase of exhalation. The manual inspiration key can be used to deliver mandatory breaths to the patient or to run an inspiratory pause maneuver in

SPONT mode. The manual inspiration key cannot be used to run an expiratory pause maneuver in SPONT mode.

Inspiratory pause key—Initiates an inspiratory pause which closes the inspiratory and exhalation valves and extends the inspiratory phase of a mandatory breath for the pur‐ poses of measuring end inspiratory pressure (P

I END

), static compliance (C

STAT

) for calculation of plateau pressure

), and static resistance (R

STAT

Expiratory pause key—Initiates an expiratory pause which extends the expiratory phase of the current breath into measure total PEEP (PEEP

Alarm reset key—Clears active alarms or resets high-priority alarms and cancels an active audio paused condition. An alarm reset is recorded in the alarm log if there is an active alarm. DEVICE ALERT alarms cannot be reset.

Audio paused key—Pauses alarms for 2 minutes. Cancel the audio paused function by touching the on-screen Cancel button.

2.10.2 GUI Touch Screen Reset

On rare occasions, the GUI touch screen may become unresponsive. If you observe an unresponsive GUI, inaccurate GUI responses, or unintended GUI responses, reset the touch screen to restore proper touch screen functionality.

To reset the touch screen:

1. Touch the display lock key on the GUI bezel to lock the screen. The locked padlock icon appears on the screen and the display lock key illuminates.

2. Touch the display lock key again. Doing so displays a progress bar below the locked padlock icon, after which time the locked icon will “unlock,” indicating a successful GUI touch screen reset.

Alternatively, ensure that a patient is not connected to the ventilator and power cycle the ventilator.

Note: Do not touch the screen during the unlock period.

Note: The manual GUI touch screen reset described in this section is different than the automatic 30-second

transient reset of the GUI described in Table 12

2.10.3 Visual Indicators

Table 9

shows the GUI’s visual indicators. See

Figure 32, page 94 for area names.

The audio paused function has two visual indicators — the audio paused key on the GUI bezel glows yellow during an audio paused interval, and a visual countdown timer appears, showing the amount of time the audio paused interval has remaining.

Table 9.

GUI Visual Indicators

Symbol Description

Ventilator setup (vent setup) button. Located at the lower left corner of the GUI.

Touch this button to open the ventilator setup screen.

Manual Event

Adult patient circuit indicator. Indicates adult circuit type tested during SST, and in use. Appears above the vent setup button.

Pediatric patient circuit indicator. Indicates pediatric circuit type tested during SST, and in use. Appears above the vent setup button.

Neonatal patient circuit indicator. Indicates neonatal circuit type tested during SST, and in use. Appears above the vent setup button.

Home icon. A constant access icon. See Figure 32, page 94

. Touch this icon to dismiss all open dialogs on the GUI screen. The display resumes showing the ven‐ tilator waveforms.

Touching this text causes the manual event screen to appear, where a variety of

events can be recorded for viewing in the Trending layout. See Chapter 17 for more

information about events

Alarms icon. A constant access icon. See Figure 32, page 94

.Touch this icon to display the alarm settings screen, which allows alarm limits to be changed.

Logs icon. A constant access icon. See

Figure 32, page 94 . Touch this icon to display

the logs screen, which contains tabs for Alarms, Settings, Patient Data, Diagnostics,

EST/ SST status, General Event, and Service logs.

Elevate O

control. A constant access icon. See

Figure 32, page 94 . Touch this icon

to temporarily increase the delivered oxygen concentration by the percent dis‐ played in the Elevate O

dialog. The ventilator will deliver the elevated O

2 tration for 2 minutes and then return the O

concentration to the set O

concen‐

% value.

Table 9.

GUI Visual Indicators (continued)

Symbol Description

For the 2-minute period, the Elevate O value between 22% and 100% O interval. The Elevate O

concentration can be set to result in any

delivery. Touching "Extend" restarts the 2-minute

function can be terminated prior to completion of the

2-minute interval by touching Stop. Any time the Elevate O entry is made to the patient data log.

control is activated, an

Screen capture icon. A constant access icon. See

Figure 32, page 94

. Touch this icon to capture the image displayed on the GUI screen. See

Section 5.4.1, GUI Screen

Capture, page 119

to read the complete procedure for capturing screen images.

Help icon. A constant access icon. See Figure 32, page 94

. Drag this icon to the item in question and release. A tooltip will appear describing the item’s function.

Unread items icon. When this icon appears overlaid on another icon or tab (the logs icon, for example) it indicates there are unread items at this location.

Configure icon. A constant access icon. See Figure 32, page 94

. Touch this icon to display the configure screen. From this screen, perform all the SST tests or a single

SST test. If performing a single test, all SST tests must subsequently be performed and passed to ventilate a patient.

Pause icon. Located above the constant access icons. Touch this icon to pause the waveform graph.

Waveform layout icon. Located above the constant access icons area. Touch this icon to open the waveform layout dialog.

Grid lines icon. Located above the constant access icons area. Touch this icon to turn waveform grid lines on or off.

Maximize waveform icon. Located at the upper right portion of each waveform.

Touch this icon to enlarge the waveform to its maximum size.

Restore waveform icon. Restores waveform to its original size. Located at the upper right of the maximized waveform.

Pushpin icon—pinned state. When in the pinned state, prevents a dialog from closing (under certain conditions). Located in the upper right corner of the GUI on

the vent setup screen. See Figure 33, page 95

Pushpin icon—unpinned state. When the unpinned icon is touched, the pinned state becomes active. Located in the upper right corner of the GUI on the vent setup

screen. See Figure 33, page 95 .

Low priority alarm icon (appears on alarm banner).

Medium priority alarm icon (appears on alarm banner).

High priority alarm icon (appears on alarm banner).

Audio paused symbol. The audio paused symbol appears together with a 2-minute countdown timer in the constant access area when the audio paused key is pressed.

See Figure 32, page 94 .

2.10.4 On-screen Symbols and Abbreviations

Touch an on-screen symbol briefly (0.5 second) to display a tooltip on the GUI screen. The tooltip contains a definition of the symbol and other descriptive text, available with either short or long descriptions. The short description expands to show more information by touching “more” on the tooltip dialog or collapses by touching ”less”. The tooltip closes by touching ”close” or fades in 5 seconds if left alone. Expanding the tooltip dialog prevents the tooltip from timing out. Touching outside the tooltip causes the dialog to close.

Table 10 summarizes the ventilator’s symbols and abbreviations.

Table 10.

Symbols and Abbreviations

Symbol or abbreviation

SENS

DYN

EEF

I END

LEAK

CIRC

LEAK

⩒

TE MAND

⩒

E SPONT

TE SPONT

E TOT

SENS

Definition

Apnea interval

Disconnect sensitivity

Dynamic compliance

Dynamic resistance

End expiratory flow

End inspiratory pressure

Exhalation leak

Monitored total circuit pressure

Exhalation leak at PEEP (Leak Sync enabled) as measured by the proximal flow sensor

Exhaled mandatory tidal volume

Exhaled minute volume

Exhaled spontaneous minute volume

Exhaled spontaneous tidal volume

Exhaled tidal volume

Expiratory sensitivity

Expiratory time

Flow pattern (ramp)

⩒

CIRC

SENS

-Trig

⩒

I:E

LEAK

Flow pattern (square)

Monitored total inspiratory and expiratory flow

Flow sensitivity

Flow triggering

Monitored inspiratory and expiratory flow measured at the proximal airway

High pressure setting (in BiLevel)

Monitored circuit pressure throughout the breath cycle measured at the proximal airway

High pressure time (in BiLevel)

High pressure time to Low pressure time ratio (in BiLevel)

Inspiratory time to expiratory time (I:E)

Inspiration compliance ratio

Inspiratory leak

Inspiratory time

Table 10.

Symbols and Abbreviations (continued)

Symbol or abbreviation

3Tau

DRIVE

PEEP

I PAV

MEAN

NIF

% (prints O2%)

0.1

PAV

% Supp

PAV

TOT

WOB

TOT

PEAK

PEF

⩒

MAX

PSF

PEEP

%Leak

COMP

SENS

SUPP

P-Trig

TIY

TEY

TI MANDY

TI SPONTY

TLY f

Definition

Inspiratory time constant

Inspiratory pressure

Inspired tidal volume

Inspired tidal volume (when Leak Sync is enabled)

Driving Pressure

Intrinsic PEEP (auto PEEP)

PAV-based intrinsic PEEP

Low pressure setting (in BiLevel)

Low pressure time (in BiLevel)

Mean circuit pressure

Negative inspiratory force

Oxygen percentage

Airway occlusion pressure at 100 ms

PAV-based lung compliance

PAV-based lung elastance

Percent support setting for Tube Compensation and PAV+™

PAV-based patient resistance

PAV-based total airway resistance

PAV-based work of breathing of patient and ventilator during inspiration

Peak circuit pressure

Peak expiratory flow

Peak inspiratory flow

Peak spontaneous flow

Set or monitored positive end expiratory pressure

Percent leak

Plateau pressure

Plateau time

Compensation pressure

Pressure sensitivity

Pressure support level

Pressure triggering

Proximal inspired tidal volume

Proximal exhaled tidal volume

Proximal mandatory inspired tidal volume

Proximal spontaneous inspired tidal volume

Proximal inspired tidal volume with Leak Sync enabled

Respiratory rate or apnea respiratory rate

Rise time percent f/V

SPONT

Spontaneous rapid/shallow breathing index

Spontaneous inspiratory time

Table 10.

Symbols and Abbreviations (continued)

Symbol or abbreviation

TOT

STAT

T CIRC

T Y

PEEP f

TOT

Definition

Spontaneous inspiratory time ratio

Static compliance

Static Resistance

Tidal Volume

Monitored total inspiratory and expiratory volumes

Monitored inspiratory and expiratory patient volumes measured throughout the breath cycle at the proximal airway

Total PEEP

Total respiratory rate (monitored)

Vital capacity

Volume support

2.10.5 Audible Indicators

A tone sounds when a button on the GUI is touched, and also when settings are accepted. Audible indicators include pitched tones, beeps, and key clicks. Key clicks sound whenever a key on the GUI is pressed. Various tones annunciate patient alarms.

Note: Pressing the audio paused key mutes alarms for the 2-minute audio paused period.

Caregivers may choose to mute alarms by pressing the audio paused key. A 2-minute countdown timer appears on the GUI during the audio paused interval. Cancel the audio paused function by touching Cancel.

Table 11.

GUI Audible Indicator Functions

Function Description

Low priority alarm tone A series of two tones. Sounds when a low priority alarm occurs.

Medium priority alarm tone

A repeating series of three tones. Sounds when a medium priority alarm occurs.

High priority alarm tone A repeating series of five tones. Sounds when a high priority alarm occurs.

Soft bound tone One tone. Sounds when a soft bound is reached when making changes to ventilator settings. A soft bound is a selected value that exceeds or goes below its limit and requires acknowledgment to continue.

Hard bound tone (inva‐ lid entry)

The invalid entry sound occurs when a hard bound is reached when making changes to ventilator settings. A hard bound defines the upper or lower limit of the setting, where the setting cannot be adjusted higher or lower.

The clinician enters ventilation parameters via the GUI’s touch screen. See Figure 1, page 28 . The keys activate other

ventilator functions. See

Table 8, page 36 .

2.11 Breath Delivery Unit

The breath delivery unit contains the hardware and software to enable the ventilator to provide patient support.

2.11.1 BDU Controls and Indicators

2.11.1.1 BDU Controls

• On/Off switch—Lift the switch cover and turn the ventilator on or off.

Figure 8.

Ventilator Power Switch and AC Indicator

1 AC power indicator

2 ON/OFF switch

• Service mode button—Press and release this button when the Covidien splash screen appears on the status display after powering on the ventilator to enter Service mode.

Figure 9.

Service Mode Button (TEST)

1 E

VEN_11246_D

1 Service mode button

Note: The Covidien splash screen shows the Covidien logo and appears momentarily as a banner on the status display.

2.11.1.2 BDU AC Indicator

The status display and the AC power indicator are the only visual indicators on the BDU. The AC indicator illuminates green whenever the ventilator is connected to AC power. All other visual indicators on the ventilator

are on the GUI. See Section 2.11.1.4, Typical Status Display Indicators and Messages, page 44

for a description of the status display indicators and symbols. See the next section for a summary of the information appearing on the status display.

2.11.1.3 Status Display

The status display is a separate display located on the BDU. See Figure 3, page 30

. The status display provides the following information according to the state of the ventilator:

During normal ventilation the status display shows

• Current power source (AC or DC)

• Safe state status: (safety valve open (SVO) or vent inop

• Presence of primary and extended batteries and their charging status

• Relative available battery charge level

• Circuit pressure graph displaying pressure units, ⤒ P

PEAK

alarm setting and current P

PEAK

and PEEP values

• Connection of air and oxygen

• Ventilator operational hours

• Visual indication of current alarm volume setting

Note: The status display provides a redundant check of ventilator operation. If the GUI stops operating for any reason, ventilation continues as set.

Figure 10 shows a sample of the status display during normal ventilation (compressor option not installed).

Figure 10.

Sample Status Display During Normal Ventilation

1 Primary and extended battery status (presence or absence).

2 Alarm volume setting

3 Gas connection status

4 Power status

5 Measured peak circuit pressure (updated at the end of the current breath)

6 P

PEAK

alarm setting

7 Measured inspiratory pressure (changes as pressure changes)

8 Selected pressure units

9 Measured PEEP

During Service mode the status display supplies

• Ventilator serial number

• Ventilator operational time

• EST and SST history

• Power on self test (POST) status

• Hours until next preventive maintenance is due

• Gas pressure at the manifold inlets

See

Table 12 for status display possibilities.

2.11.1.4 Typical Status Display Indicators and Messages

Table 12 lists indicators and messages that appear on the status display.

Note: Status display messages are shown without the optional DC compressor installed.

Table 12.

Status Display Indicators and Descriptions

Status Display Indicator or Message Meaning

Splash screen. Appears when the ventilator’s power switch is turned on. When this image appears, press and release the TEST button at the back of the ventila‐ tor to enter Service mode.

POST failure. This image appears if a POST error occurs at ventilator startup, along with the error code (in this case a missing primary battery).

Failure of the exhalation flow sensor assembly (EVQ) during power on self test. Confirm proper installation of the exhalation flow sensor assembly and power cycle the ventilator. See

Section 7.5.3, EVQ Replacement, page 182 for proper EVQ installation instructions.

Failure of the EVQ during power on self test. Reinstall or replace the EVQ and run flow sensor calibration. See

Section 7.5.3, EVQ Replacement, page 182

for proper EVQ installation instructions.

Table 12.

Status Display Indicators and Descriptions (continued)

Status Display Indicator or Message Meaning

Prior to patient connection. The status display appears as shown when the patient has not been connected to the ventilator. Note the absence of P

PEAK ues.

and PEEP val‐

Stand-By state. The status display appears as shown when the ventilator is in stand-By state.

Battery charged. The ventilator’s primary battery (in the right-most receptacle) is shown fully charged. The per‐ centage indicator shows 100%.

Battery charging or discharging. Identifies that the ven‐ tilator’s primary battery is charging or discharging and provides its relative capacity. If an extended battery is installed, the image shows a similar representation in the extended battery location (left-most receptacle).

Battery icon. Denotes the ventilator is operating on battery power when this image appears on any status display indicator. Alerts the operator there is insuffi‐

Table 12.

Status Display Indicators and Descriptions (continued)

Status Display Indicator or Message Meaning cient AC power to operate the ventilator. The indicator is replaced by the “on AC power” indicator when ade‐ quate AC power is restored.

On battery power. Alerts the operator there is insuffi‐ cient AC power to operate the ventilator. Ventilator is operating on battery power with greater than 10 minutes of capacity remaining. Note the appearance of the battery icon.

Low battery. Identifies that the ventilator’s primary bat‐ tery (right-most receptacle) is discharging and there are 10 minutes or less of battery capacity remaining. A percentage indicator shows the remaining battery capacity. If an extended battery is installed, the image would show a similar representation in the extended battery location (left most receptacle).

Critically low battery. Identifies that the ventilator’s pri‐ mary battery has less than 5 minutes of battery capacity remaining. A percentage indicator shows the remaining battery capacity. If an extended battery is installed, the image would show a similar representa‐ tion in the extended battery location.

Power failure. Alerts the user that the ventilator’s bat‐ tery is depleted or depletion is imminent. Replace pri‐ mary or extended battery with a fully charged battery or connect the ventilator to AC power.

Table 12.

Status Display Indicators and Descriptions (continued)

Status Display Indicator or Message Meaning

Battery Inoperative. This image appears on the status display when a battery fault renders the battery inop‐ erative.

Battery not installed. This image appears when there is no primary battery installed, and renders the ventilator inoperative.

GUI Transient Reset. Indicates there is a transient loss of communication between the BDU and the GUI. It occurs in the ventilator by design to maintain full GUI display functionality. During the GUI transient reset, ventilation continues as currently set, audible and vis‐ ual alarms are NOT annunciated, and the status display shows a count-down timer until the completion of the

GUI transient reset. The count-down lasts for approxi‐ mately 30 s.

GUI Failure. Indicates a loss of communication between the BDU and the GUI that cannot be recov‐ ered by the ventilator system. During the GUI failure, ventilation continues as currently set, audible and vis‐ ual alarms ARE annunciated, and the status display shows “Display Failed.” Replace the ventilator as soon as it is appropriate to do so. Service the ventilator prior to returning it for use on patients. Recommended actions for GUI failure condition:

• Verify the patient’s respiratory and physiological stability.

• Confirm that the patient is receiving ventilatory support by observing expansion and contraction of the patient’s chest.

Table 12.

Status Display Indicators and Descriptions (continued)

Status Display Indicator or Message Meaning

• Assess patient status by reviewing other monitor‐ ing indicators (for example, oxygen saturation, heart rate, blood pressure, etc.).

• Transfer the patient to an alternate source of ven‐ tilation consistent with your institution’s protocol.

Ventilator inoperative (Vent Inop). Indicates the venti‐ lator is no longer capable of ventilating a patient and requires service. The alarm reset key cannot be used to restore function to the ventilator during a ventilator inoperative condition. Provide alternate means of ven‐ tilation immediately Note the display of the safety valve open indicator.

Safety valve open (SVO) indicator. During SVO, the patient can breathe room air through the safety valve, to the extent the patient is able to breathe unaided. See

Section 4.11.6, Safety Valve Open (SVO), page 117 .

Backup ventilation (BUV) indicator. Indicates the ven‐ tilator has entered the backup ventilation state. See

Section 10.16.4, Background Diagnostic System, page 240

on page for a description of BUV.

AC power indicator. When this image appears on any status display indicator, indicates the ventilator is oper‐ ating on AC power.

Table 12.

Status Display Indicators and Descriptions (continued)

Status Display Indicator or Message Meaning

Status display appearance when ventilator is breathing in Normal mode. Note the appearance of the AC power icon.

Air available indicator. When this image appears on any status display indicator, indicates the ventilator is con‐ nected to a pressurized air source.

available indicator. Indicates ventilator is connected to a pressurized O

source.

2.11.1.5 BDU Audible Indicators

The continuous tone alarm is the only audible indicator in the BDU, and is described in

Table 13 .

Table 13.

BDU Audible Indicator Functions

Indicator

Continuous tone alarm (Imme‐ diate priority)

Description

A continuous tone annunciated when there is a Ventilator Inoperative (vent inop) condition. This alarm lasts for a minimum of 2 minutes.

2.11.2 Connectors

The ventilator incorporates the following connectors:

• Ventilator outlet port (to patient) — A coaxial 15 mm (ID) / 22 mm (OD) conical connection to which the external inspiratory bacteria filter attaches.

• Exhalation port (from patient) — The expiratory limb of the patient circuit attaches to the inlet of the exhalation bacteria filter. This port is compatible with a standard 22 mm (OD) conical connection.

• Proximal flow sensor — A keyed pneumatic connector for the proximal flow sensor is provided with a locking feature to prevent inadvertent disconnection. The proximal flow sensor measures flow and pressure at the patient wye. The proximal flow sensor is an optional sensor. Details on operation are provided in the appendix in this manual. See

Chapter 16 .

• Standard interface connectors — USB, HDMI, and Ethernet connectors are provided. The USB connector allows screens to be captured on an external USB storage device and allows communication with an external patient monitor via serial over USB protocol, and the HDMI connector allow the GUI image to be displayed on an external video display device. The Ethernet connector is used by service personnel to upload new

software and options. See Section 5.5.1, Port Use, page 131

for more information. See Section 5.4.3, Comm Port

Configuration, page 121 for information on serial over USB data transfer when configuring Comm ports for

external devices.

2.12 Additional Equipment

An optional DC compressor is available to provide compressed air in the event the wall or bottled air supply is lost or is unavailable. The compressor receives DC power from its own power supply if AC power is present. If there is no AC power available, the compressor is powered by its internal battery. The compressor interface printed circuit board assembly (PCBA) communicates with the BDU CPU PCBA. See the Compressor Operator’s Manual

Addendum for details regarding compressor operation.

Warning: Use of the compressor in altitudes higher or barometric pressures lower than those specified could

compromise ventilator or compressor operation. See Table 63, page 247

2.13 Special Features

A Proximal Flow option is available. The proximal flow sensor is used to measure low flows and pressures associated with neonatal ventilation. If the ventilator is configured with this option. See

Chapter 16 for more

information.

2.14 Color Definitions

Reference the figures in

Table 14 to view the ventilator’s pneumatic diagram during inspiration with various colors

representing the gases.

Table 14.

Color Legend

Color or Symbol Description

High-pressure oxygen (NFPA 99 designation)

High-pressure air (NFPA 99 designation)

Mixed gases, including air

Atmosphere

Vacuum

Water

2.15 Pneumatic Diagrams

Note: Both the compressor and the Proximal Flow option are hardware options.

Figure 11 and

Figure 12

illustrate the ventilator’s pneumatics with and without the optional Proximal Flow option.

The Proximal Flow option is only for use with neonatal patients.

Figure 11.

Pneumatic Diagram (Compressor Shown)

1 Pressure switch, mix accumulator (PS1)

2 Solenoid Valve, options supply (SOL2)

3 Pressure sensor, mix accumulator (P

)

4 Accumulator, mix (ACC

)

5 Tube, mix (T

)

6 Proportional solenoid valve, patient gas delivery (PSOL

)

7 Solenoid valve, BUV (SOL 3)

8 Safety valve (SV)

9 Pressure sensor, safety valve (P

)

10 Solenoid valve, inspiratory pressure sensor autozero (SOL4)

11 Pressure sensor, inspiratory (P

)

12 Pressure sensor, barometric (PA)

13 Vial, exhalation condensate

14 Filter, exhalation (F4)

15 Flow sensor assembly, exhalation valve

16 Exhalation valve (EV)

17 Filter, exhalation pressure line (F5)

18 Solenoid Valve, exhalation pressure autozero (SOL 5)

19 Pressure sensor, exhalation (PE)

20 Humidifier

21 Filter, External bacteria (F

)

22 Filter, Internal bacteria (F

)

23 Check valve, patient gas delivery (CV

)

24 Sensor, Oxygen (OS)

25 Restrictor, breath delivery bypass (R2)

26 Flow sensor, patient gas delivery (FS

)

27 Accumulator, compressor (ACC

)

28 Relief valve, compressor accumulator (RV

)

29 Solenoid valve, compressor unload (SOL7)

30 Motor Compressor (MC)

31 Heat exchanger, compressor (HE)

32 Filter, compressor air (F7)

33 Dryer, compressor

34 Filter, muffler (F6)

35 Check valve, compressor accumulator (CV

)

36 Pressure sensor, compressor accumulator (PC)

37 Check valve, Oxygen (CVO

)

38 Check valve, Air (CV

Air

)

39 Proportional solenoid valve, Oxygen (PSOLO

)

40 Flow sensor, Air (FS

Air

)

41 Proportional solenoid valve, Air (PSOL

Air

)

42 Pressure sensor, air gas inlet (P

Air

)

43 Restrictor, wall air bleed outlet (R1)

44 Check valve, compressor air inlet (CV

CAir

)

45 Filter bowl assembly, Air (WT2)

46 Filter element, Air (F2)

47 Check valve, wall Air inlet (CV

WAir

)

48 Filter, Oxygen Impact (F1)

49 Filter element, Oxygen (F3)

50 Pressure sensor, Oxygen gas inlet (PO

)

51 Flow sensor, Oxygen (FSO

)

52 Restrictor, Prox Flow (R4)

53 Relief Valve, mix accumulator (RVMA)

54 Solenoid Valve, mix accumulator purge (SOL 1)

Figure 12.

Pneumatic Diagram — Compressor and Prox Flow Systems

1 Restrictor, Prox Flow (R4)

2 Solenoid Valve, Prox Flow (SOL 6)

3 Module, Proximal Flow System

4 Pressure Sensor, Prox Flow Accumulator (P

PROX

)

5 Humidifier

6 Wye, patient circuit

7 Sensor, Proximal Flow

8 Filter, neonatal exhalation

9 Condensate vial, neonatal expiratory

Items enclosed by dotted line represent components internal to the ventilator.

3 Installation

3.1 Overview

This chapter contains information for the installation and set up of the Puritan Bennett 980 Series Ventilator. Before operating the ventilator system, thoroughly read this operator’s manual.

Topics include:

• Safety reminders

• Ventilator setup

• Battery information

• Ventilator operating modes

• Preparing the ventilator for use

• Tests to perform prior to ventilating a patient

3.2 Safety Reminders

Warning: Explosion hazard—Do not use in the presence of flammable gases. An oxygen-rich environment accelerates combustibility.

Warning: To prevent electrostatic discharge (ESD) and potential fire hazard, do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system.

Warning: Use only gas supply hoses approved by Covidien. Other hoses may be restrictive and may cause improper ventilator operation.

Warning: To avoid possible injury, lock the ventilator’s casters prior to installing or removing ventilator components.

Caution: To ensure optimum performance, Covidien recommends preventive maintenance be performed by a

Covidien-trained service technician per the schedule specified. See Table 44

3.3 Product Assembly

3.3.1 How to Assemble Ventilator Components

Ventilator setup should have already been completed by a Covidien-trained service technician including successfully passing EST. This manual does not include ventilator assembly instructions.

3.3.2 Product Power Sources

3.3.2.1 Using AC Power

The ventilator is normally AC-powered. See

Section 3.5.1, Connecting the Ventilator to AC Power, page 57 to connect

the ventilator to AC power.

3.3.2.2 Using Battery Power

Warning: Use only Covidien batteries. Using other manufacturer’s brands could result in the batteries operating the ventilator for less than the specified amount of time or could cause a fire hazard.

Warning: One primary battery must be installed at all times in the BDU’s primary battery slot for proper ventilator operation. The ventilator will not complete the startup process without the primary battery installed. See

Figure 28, page 71

for identification of battery slots.

The ventilator’s primary battery must be installed by a Covidien-trained service technician (as it is shipped separately) before patient use. The ventilator will not complete Power on Self Test (POST) if the battery is not present, and ventilation is prohibited. Ensure the battery is fully charged before placing the ventilator into service.

The ventilator employs a battery backup system if AC power becomes unavailable or drops below approximately

90 volts. A new, fully charged battery provides at least 1 hour of power to the ventilator assuming ambient temperature of 20°C (68°F) to 25°C (77°F), PBW=70 kg, and at factory default ventilator settings.

The battery backup systems for the ventilator and compressor contain one primary battery each. Backup power is supplied to the ventilator in the event of an AC power loss.

One extended battery receptacle is available for the ventilator and one extended battery receptacle is available for the compressor. If both primary and extended ventilator and compressor batteries are present, these batteries can power the ventilator and compressor for 2 hours (1 hour for the primary battery and 1 hour for the extended battery) under the environmental conditions described above. When using battery power, the ventilator and compressor operate from their extended batteries, if present, first and then switch to the primary batteries. The ventilator and compressor primary and extended batteries are charged whenever the ventilator is plugged into

AC power (the ventilator does not have to be powered up). If the ventilator or compressor is operating on battery power, the status display shows which battery is in use and its charge level, and the remaining time the battery will operate before charging is required again.

3.3.2.3 Battery Charging

Batteries requiring charging are charged whenever the ventilator is connected to AC power, whether operating or not.

The ventilator and compressor charge their primary batteries first, then their extended batteries. The time required to charge a single battery (either primary or extended) is approximately 6 hours at room temperature whether the ventilator is turned off (but connected to AC power) or operating, but charging time can vary based on temperature or depletion state of the battery. The status display provides the batteries’ capacities.

The compressor’s battery charging system (if a compressor is present) operates independently from the ventilator’s charging system and batteries are charged in parallel.

If a battery fault occurs, the fault is annunciated, charging of the faulty battery discontinues, but charging of any other non-faulty battery continues. A faulty battery will cause annunciation of the error and battery power will not be available for the ventilator.

The ventilator status display indicates the charge level of the installed batteries, the presence of one or more battery faults, and which battery is being charged.

The ventilator operates no differently when its batteries are charging than it does when the batteries are fully charged.

The ventilator continues operating as set when the ventilator switches from AC power to battery power and illuminates an indicator on the status display alerting the operator that the ventilator is now operating on battery power and the AC POWER LOSS alarm annunciates. A medium priority alarm annunciates when the remaining run-time for the ventilator drops to 10 minutes and a high priority alarm annunciates when the remaining time drops to 5 minutes.

3.4 Product Placement

The ventilator is positioned standing on its casters next to the patient’s bedside, as shown in Figure 13 or if using a pendant-mounted configuration, Figure 14

Move the ventilator using the handle encircling the BDU and roll the ventilator to the desired location.

Figure 13.

Example of Freestanding Ventilator Placement

Figure 14.

Example of Pendant-mounted Ventilator

3.5 Product Connectivity

3.5.1 Connecting the Ventilator to AC Power

Note: Power outlet access and power cord position — Ensure that the power outlet used for the ventilator is easily accessible; disconnection from the outlet is the only way to completely remove power from the ventilator.

To connect the power cord to AC power

1. Plug the ventilator into a properly grounded power outlet rated for at least 15 A.

2. Verify the connection by checking the AC indicator below the power switch on the front of the BDU. See

Figure 8, page 42

for the power switch and AC indicator locations.

To connect the power cord to the ventilator

1. Remove the power cord retainer and connect the female end of the power cord to the ventilator’s power cord receptacle. See

Figure 15, page 58 or

Figure 16, page 59

2. Set hex nuts and spacers, if present, aside for reassembly.

3. Replace the power cord retainer using the hex nuts and spacers removed during disassembly. See

Figure 15, page 58

or Figure 16, page 59

Note: Your ventilator may have either combination of power cord and retainer.

Use the power cord hook located at the back of the ventilator for power cord storage.

Warning: For proper ventilator operation, and to avoid the risk of electric shock, connect the ventilator to a grounded, hospital-grade, AC electrical outlet.

Figure 15.

Power Cord Retainer on BDU (without spacers)

1 1/4 in. hex nuts

2 Power cord retainer

3 AC power cord

Figure 16.

Power Cord Retainer on BDU (with spacers)

1 1/4 in. hex nuts

2 Power cord retainer

3 AC power cord

4 Spacers

3.5.2 Connecting the Gas Supplies

The ventilator can be connected to hospital grade wall or bottled air and oxygen. See Figure 17, page 60 . Both air

and O

supply pressure ranges must be between 241.3 kPa and 599.8 kPa (35 psig and 87 psig) and the average flow requirement for both gases is 60 L/min at 40.61 psi. The transient will not exceed 200 L/min for ≥3 seconds.

Warning: Due to excessive restriction of the Air Liquide™*, SIS, and Dräger™* hose assemblies, reduced ventilator performance levels may result when oxygen or air supply pressures <345 kPa (50 psi) are employed.

Gas cross flow from one high pressure input port of one type of gas to another high pressure input port of a different gas will not exceed 100 mL/h under normal or single fault conditions. If, during a single fault condition, cross flow exceeds 100 mL/h, an audible alarm annunciates.

wall air inlet and oxygen inlet. See Table 37

for alarms that occur due to a loss of gas supplies.

To connect the gas sources

1. Connect the oxygen hose to the oxygen inlet fitting (item 1) as shown in

Figure 17, page 60

. Ensure use of a medical grade oxygen source.

2. Connect the air hose to the air inlet fitting (item 2) as shown.

Figure 17.

Connecting the Ventilator to the Gas Supplies

1 O

gas connection

2 Air gas connection

Warning: To prevent a potential fire hazard and possible damage to the ventilator, ensure the connections to the gas supplies are clean and unlubricated, and there is no water in the supply gas. If water is suspected, use an external wall air water trap to prevent damage to the ventilator or its components.

The ventilator system can be purchased with the following gas inlet fittings for both air and O

2 female, NIST, Air Liquide™*, SIS, and Dräger™*.

: BOC, DISS, DISS

See

Table 45 for part numbers of gas hoses. For countries outside the USA, contact your local Covidien

representative for the proper gas hoses.

3.5.3 Filter Installation

The ventilator is shipped with internal and external inspiratory filters. See Table 45 . To prevent infection and

contamination, both inspiratory and exhalation filters must be used with the ventilator.

Warning: To reduce the risk of infection, always use the ventilator with inspiratory and exhalation bacteria filters.

Warning: Do not attempt to use inspiratory or exhalation filters designed for use with ventilators other than the

Puritan Bennett 980 Series Ventilator. See Table 45

for relevant part numbers.

Warning: Refer to the filter’s IFU for details such as cleaning and sterilization requirements, filtration efficiency, proper filter usage, and maximum filter resistance, particularly when using aerosolized medications.

Warning: Refer to the exhalation filter IFU for information on reusable filter cleaning and sterilization and filter efficiency.

Warning: Do not reuse disposable inspiratory or exhalation filters, and dispose according to your institution’s policy for discarding contaminated waste.

Caution: Ensure both inspiratory and exhalation filters are properly attached to the ventilator.

To install the inspiratory filter

1. Attach the inspiratory filter to the To patient port.

2. Ensure the direction of flow arrow is pointing outward, toward the patient circuit’s inspiratory limb.

Note: Refer to the inspiratory filter instructions for use (IFU) for information on proper use and handling of the filter.

Note: Refer to the exhalation filter IFU for information on proper use and handling of the filter and for emptying

the condensate vial for adult and pediatric patients. See Chapter 15

for information on emptying the condensate vial when using neonatal exhalation filters.

The condensate vial must be assembled to the reusable exhalation filter prior to installing the assembly to the ventilator.

To assemble the Adult/Pediatric reusable exhalation filter and condensate vial

1. Seat the filter to the condensate vial, ensuring alignment of the condensate vial’s seal with the mating edge of the exhalation filter.

2. Twist the condensate vial in a counterclockwise direction until the stops on the vial and exhalation filter meet.

Warning: Do not operate the exhalation filter latch during patient ventilation. Opening the latch during ventilation will result in a patient disconnect condition and corresponding alarm.

To install the adult/pediatric exhalation filter

1. If necessary, remove expiratory limb of patient circuit from exhalation filter.

2. Raise the exhalation filter latch to unlock (item 6). This raises the exhalation valve assembly and allows the

filter door to swing away from the ventilator. See Figure 18, page 62

3. Open the exhalation filter door.

4. Remove the existing filter.

5. Insert the new filter by sliding the filter along the tracks in the door. Ensure the from patient port aligns with the cutout in the door and points away from the ventilator.

6. Close the exhalation filter door.

7. Lower the exhalation filter latch to secure the filter.

Note: To prevent EVQ misalignment and potential damage, ensure there is an exhalation filter in place any time the ventilator is transported from one location to another.

Figure 18.

Adult/Pediatric Filter Installation

1 Condensate drain port

2 Condensate vial

3 Exhalation filter

4 Condensate vial gasket

5 Condensate drain port cap

6 Exhalation filter latch

7 Exhalation filter door

To install the neonatal exhalation filter adapter door

1. If necessary, remove expiratory limb of patient circuit from exhalation filter.

2. Lift exhalation filter latch. See

Figure 19, page 62 (item 3).

3. Remove the existing exhalation filter door by lifting it off of the pivot pins.

4. Fit the neonatal adapter door onto the pivot pins.

Figure 19.

Installing the Neonatal Filter

1 Neonatal exhalation filter

2 Neonatal adapter door

3 Exhalation filter latch

4 Filter door pivot pin

To install the neonatal exhalation filter assembly

1. With the door still open, push the neonatal filter assembly straight up into the adapter.

2. Close the door.

3. Lower the exhalation filter latch.

4. Reattach the expiratory limb of the patient circuit to the filter.

To use the drain bag

1. Remove the drain port cap from the exhalation filter condensate vial drain port.

2. Attach the drain bag tube to the condensate vial’s drain port.

3. Hang the drain bag on the holder located on the ventilator’s accessory rail, as shown in

Figure 20

. See Table 45

for the part number of the drain bag holder.

Figure 20.

Drain Bag

3.5.4 Flex Arm

Use the flex arm to support the patient circuit between the patient and the ventilator. See

Figure 21, page 64 ,

which illustrates flex arm installation into the sockets provided.

Figure 21.

Flex Arm Installation

VEN_10330_A

To attach or remove the flex arm

1. Locate the threaded inserts in the ventilator’s handle.

2. Fasten the flex arm into one of the inserts.

3. Hang the patient circuit using the circuit management supports included with the flex arm.

4. Remove the flex arm by first removing the patient circuit, then unfastening the flex arm from the threaded fastener in the handle.

3.5.5 Humidifier

Use the humidifier to add heat and moisture to the inhaled gas. Connect the humidifier to a hospital grade electrical outlet. Choose the humidifier (type and volume appropriate for the patient). The humidifier may be

mounted with the humidifier bracket as shown in Figure 22, page 65

. See

Table 45 for the part number of the

humidifier bracket.

Warning: Selection of the incorrect humidifier type or volume during SST or during patient ventilation can affect the accuracy of delivered volume to the patient by allowing the ventilator to incorrectly calculate the compliance correction factor used during breath delivery. This can be a problem, as the additional volume required for circuit compressibility compensation could be incorrectly calculated, resulting in over- or under-delivery of the desired volume.

Warning: To ensure proper compliance and resistance calculations, perform SST with the humidifier and all accessories used for patient ventilation installed in the ventilator breathing system.

Warning: Follow the humidifier manufacturer’s IFU when using a humidifier with patient ventilation.

Caution: Follow the humidifier manufacturer’s IFU for proper humidifier operation.

To install the humidifier bracket

Attach the humidifier bracket to the ventilator’s accessory rail by placing the bracket behind the railing and fastening the bracket clamp to the bracket with four 5/32 inch hex screws, capturing the railing between the bracket and the clamp. Ensure the humidifier mounting slots are facing outward from the ventilator.

Figure 22.

Bracket Installation on Rail

To install the humidifier

1. Slide the rear of the humidifier into the corresponding slot on the humidifier bracket, until it is fully seated.

See

Figure 23, page 66 . Some humidifiers slide into the narrow slot in the humidifier bracket, and some

humidifiers use the wide slot.

Figure 23.

Humidifier Installation to Ventilator

2. Fill the humidification system with water to the desired fill volume.

3. Install the chamber to the humidifier, connect the patient circuit, then run SST.

4. Plug the humidifier into a grounded, hospital grade electrical outlet.

5. Turn the humidifier on.

Note: Complete instructions for the humidifier bracket and humidifier installation are given in the

Puritan Bennett 980 Series Ventilator Humidifier Bracket Installation Instructions , which includes humidifier bracket part numbers and descriptions.

3.5.6 Connecting the Patient Circuit

Warning: Use patient circuits of the lowest compliance possible with the ventilator system to ensure optimal compliance compensation and to avoid reaching the compliance compensation limit. See

Table 15 for circuit

types corresponding with predicted body weight (PBW).

Table 15.

Patient Types and PBW Values

Circuit Type

Neonatal

Pediatric

PBW in kg (lb)

0.3 kg to 7.0 kg (0.66 lb to 15 lb)

7.0 kg to 24 kg (16 lb to 53 lb)

Adult 25 kg to 150 kg (55 lb to 331 lb)

Allowed but not recommended

Not applicable

3.5 kg to 6.9 kg and 25 kg to 35 kg

(7.7 lb to 15 lb and (55 lb to 77 lb)

7.0 kg to 24 kg

(16 lb to 53 lb)

Note: Refer to the patient circuit’s IFU for information on proper use and handling and care and maintenance of the circuit.

A list of breathing system components and accessories is provided in Table 45

. Use only Covidien components and accessories in the patient circuit.

Follow your institution’s protocol for safe disposal of the patient circuit.

Follow the patient circuit’s IFU for cleaning and disinfection information for reusable circuits.

Orient the patient circuit by hanging the patient circuit on the circuit management supports provided with the flex arm.

Figure 24.

Connecting the Adult or Pediatric Patient Circuit

1 Humidifier

2 Inspiratory limb

3 Circuit wye

4 Expiratory limb

5 Condensate vial

6 From Patient port

7 Exhalation filter

8 To patient port

9 Inspiratory filter

Figure 25.

Connecting the Neonatal Patient Circuit

1 Humidifier

2 Patient circuit inspiratory limb

3 Circuit wye

4 Patient circuit expiratory limb

5 Condensate vial

6 From patient port

7 Neonatal exhalation filter (installed in adapter door)

8 To patient port

9 Inspiratory filter

Warning: Do not attempt to sterilize single-patient use circuits.

3.6 Batteries

Warning: Use only Covidien-branded batteries. Using other manufacturer’s brands or remanufactured batteries could result in the batteries operating the ventilator for less than the specified amount of time or could cause a fire hazard.

Warning: To reduce the risk of infection due to cross-contamination, using a damp cloth, disinfect the batteries with one of the solutions listed before installation and whenever transferring to or from another ventilator. During

use, clean external surfaces of batteries as necessary. Table 40, page 172 . Do not spray disinfectant directly onto the

battery or its connector.

Warning: Even though the Puritan Bennett 980 Ventilator meets the standards listed in

Chapter 11 , the internal

lithium-ion battery of the device is considered to be Dangerous Goods (DG) Class 9 - Miscellaneous, when transported in commerce. As such, the Puritan Bennett 980 Ventilator and the associated lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA: International

Air Transport Association), International Maritime Dangerous Goods code for sea and the European Agreement

concerning the International Carriage of Dangerous Goods by Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements may apply.

Warning: To avoid the risk of fire, explosion, electric shock, or burns, do not short circuit, puncture, crush, heat above 60°C, incinerate, disassemble the battery, or immerse the battery in water.

Caution:

Ensure the batteries are oriented properly. See Figure 27

Figure 26.

Ventilator Battery

1 Battery connector

3.6.1 Primary Batteries

The ventilator’s primary battery is located in the rearward battery receptacle on the right side of the BDU. The compressor’s primary battery is located in the rearward battery receptacle in the compressor base. See

Figure 28, page 71

. The primary battery may be “hot swapped,” that is it can be replaced while the ventilator is operating.

To install or replace the primary battery in the BDU or compressor

1. Check the charge level by pressing the charge level button on the battery and verifying the charge level

LEDs illuminate. See

Figure 27 for the location of the charge level button. Five green LED segments

illuminate, indicating ≥ 90% battery capacity. From bottom to top, the first LED indicates ≥10% capacity, the second LED indicates ≥25% capacity, the third LED indicates ≥50% capacity, and the fourth LED indicates

≥75% capacity. An illuminated red LED at the top of the battery indicates a battery fault. If no LEDs illuminate it means there is <10% battery capacity remaining.

2. If the charge level is sufficient, orient the battery as shown, face the front of the ventilator and locate the battery compartments on the right side of the appropriate module. See

Figure 28, page 71

. The receptacle

towards the rear of the ventilator houses the primary battery while the receptacle towards the front of the ventilator houses the extended battery.

3. The primary battery is fastened in place with a thumbscrew (item 3). Loosen the thumbscrew approximately four to five turns to allow battery installation.

4. Insert the battery and push into its receptacle all the way until it clicks, indicating it is latched. The battery will only fit into the slot one way.

Figure 27.

Proper Battery Orientation

VEN_10327_A

1 Charge status LEDs

2 Charge level button

5. Tighten the thumbscrew to secure the battery and prevent the primary battery from being removed.

Note: Remove the primary battery by reversing the steps. After loosening the thumbscrew, slide the battery ejector to the left to eject the battery.

Figure 28.

Battery Compartment Locations

1 2

6 VEN_10278_B

1 BDU extended battery receptacle and ejector

2 BDU primary battery receptacle and ejector

3 Compressor extended battery receptacle and ejector

4 BDU and compressor primary battery thumbscrews

5 Compressor primary battery receptacle and ejector

6 BDU primary battery (positioned for installation)

Note: Remove either primary battery by sliding the battery ejector to the left. The battery ejects itself from its receptacle.

3.6.2 Extended batteries

The extended battery receptacle is located forward of the primary battery. Like the primary battery, the extended battery may be hot swapped.

To install or remove an extended battery in either the BDU or compressor

1. Properly orient the battery as shown in

Figure 27

2. Push the battery into the forward receptacle of the appropriate module of the ventilator all the way until it clicks, indicating the battery is latched (

Figure 28 ).

Note: Remove the battery by sliding the battery ejector to the left. The battery ejects itself from its receptacle.

There is no thumbscrew for extended batteries.

3.6.3 Battery Testing

To test the batteries

With the battery installed in the ventilator, push the battery charge level button located on the battery. A series of LEDs illuminates, indicating the charge level of the battery. When the bottom LED is illuminated, there is ≥10%

of full battery capacity. The next LED illuminates when there is ≥25% capacity. the third lamp illuminates when there is ≥50% capacity available. The fourth LED illuminates when there is ≥75% capacity, and when the top LED

is illuminated it represents ≥ 90% capacity. See Figure 27 to view the battery test button and LEDs.

3.6.4 Battery Life

Battery life for both primary and extended batteries is approximately 3 years from the date of manufacture. Actual battery life depends on the history of use and ambient conditions. As the batteries age with use, the time the ventilator will operate on battery power from a fully charged battery will decrease. Replace the battery every 3 years or sooner if battery operation time is insufficient for your usage or if indicated in the GUI prompt area. The user is informed on the GUI prompt area that the battery is nearing the end of service life. The prompt occurs a minimum of 90 days ahead of end of life for nominal use conditions. The battery requiring replacement is identified in the System Communication Log.

Determine which battery is nearing the end of its service life by accessing the ventilator logs.

1. Touch the Logs icon in the constant access area of the GUI.

2. Touch Diagnostics.

3. Touch System Comm Log. For each impacted battery, there will be an entry like the example shown in

Table 16 , including the location of the battery and its serial number.

Table 16.

Example of Battery End of Service Life Log

Time/Date

HH:MM:SS

DD-Month-YYYY

HH:MM:SS

DD-Month-YYYY

HH:MM:SS

DD-Month-YYYY

HH:MM:SS

DD-Month-YYYY

Test/Event

Ventilator Primary battery is nearing end of service life

Ventilator Extended bat‐ tery is nearing end of serv‐ ice life

Compressor Primary bat‐ tery is nearing end of serv‐ ice life

Compressor Extended battery is nearing end of service life

Code

E00041

E00042

E00043

E00044

Notes

SN XXxxXXXXXX

3.6.5 Battery Manufacturing Date

The date of manufacture of the battery is contained in the serial number. The serial number is listed on the side of the battery near the connection point. The serial number consists of 10 alphanumeric characters and provides the following information: 2 character year, 2 character week, 2 character text character, and 4 character sequence.

Figure 29.

Battery Serial Number

1 Year

2 Week number (XX of 52)

3 Text

4 Build sequence number

3.6.6 Battery Disposal

The battery is considered electronic waste and must be disposed of according to local regulations.

Follow local governing ordinances and recycling plans regarding disposal or recycling of the battery.

3.6.7 Li-ion Battery Pack Handling, Storage and Replacement

3.6.7.1 Handling, Storage and Maintenance

Lithium-ion (Li-ion) battery packs (P/N 10086042) handling, storage and maintenance is recommended as follows:

• Battery packs should be installed in the ventilator or compressor (if the option is installed) while connected to AC Power to maintain charge, whether the ventilator is operating, in standby, or off.

• Battery packs not installed in a ventilator should have the charge level checked prior to use. This can be done

by pressing the charge level button. See Section 3.6

and

Figure 30

. It is recommended that battery packs displaying a charge level equivalent to one LED or fewer be fully charged prior to patient use.

• Battery pack life will be reduced if the battery pack is repeatedly allowed to fully deplete.

• Battery packs that display a red fault LED (noted in Section 3.6.7.2

) should not be used.

• Battery packs that are not installed in a ventilator should be stored in the orientation illustrated in Figure 30

and in Section 3.6

3.6.7.2 Replacement and Disposal

Li-ion battery pack (P/N 10086042) replacement and disposal:

Section 3.6.5

, users are reminded to replace the battery pack every 3 years from date of manufacture and dispose

of the battery packs according to local regulations. The date of manufacture is reflected within the serial number

sequence found on the battery pack. See Figure 29

for guidance on how to determine this date or follow the use-by date indicated on the battery pack labeling.

If a battery fault occurs, it will be indicated by an illuminated red fault LED or on the ventilator status display. If this occurs within 3 years from date of manufacture, contact our service experience group

([email protected]) to arrange for return and replacement of the battery pack.

Figure 30.

Battery Charge Level

1 White battery in use LED

2 Red battery fault indicator

3 Green charge status LEDs

4 Charge level button

3.7 Ventilator Operating Modes

3.7.1 Normal Mode

Normal mode is the default mode used for patient ventilation. The ventilator enters Normal mode after it has been turned on and POST completes, the ventilator is set up, and breath delivery parameters have been entered. The clinician can select Quick Start, which uses default values or institutionally configured breath delivery settings after PBW has been entered. Entry into Normal mode is not allowed if a primary battery is not detected in the ventilator BDU, a major POST fault occurs, or there is an uncorrected major system fault, or uncorrected Short Self

Test (SST) or Extended Self Test (EST) failures or non-overridden alerts.

During Normal mode, the omni-directional LED on the top of the GUI appears green in color, in a steadily lit state.

If an alarm occurs, the LED flashes in a color corresponding to the priority of the alarm. See Table 34, page 144

for details regarding alarm priority. If another alarm occurs concurrently with an existing alarm, the LED displays the color corresponding to the highest priority level. If the alarm deescalates, the latched area (located on either side of the alarm LED indicator) of the alarm LED displays the color of the highest priority alarm while the center of the

LED displays the color of the current alarm’s priority. For more information on specific alarms, touch the logs icon in the constant access icons area of the GUI.

3.7.2 Quick Start

Quick Start is an extension of Normal mode, where institutionally configured default settings are applied after the patient’s PBW or gender and height are entered and Quick Start is touched to begin ventilation.

3.7.3 Stand-By State

Stand-By state can be used when the clinician needs to disconnect the patient for any reason (prior to a suction procedure, for example). The ventilator enters Stand-By state if a request is made by the clinician, a patient is disconnected within a fixed time period determined by the ventilator software, and the clinician confirms the

3 patient has been disconnected intentionally. If a patient becomes disconnected from the patient circuit after the time period elapses, an alarm sounds and the patient-disconnect sequence is initiated. In Stand-By state, gas output is reduced to ten L/min to limit gas consumption and to allow for detection of patient reconnection.

Stand-By state is available in all ventilation modes except during inspiratory and expiratory BUV , Occlusion

Status Cycling (OSC) , Safety Valve Open (SVO) , or Ventilator Inoperative (Vent Inop) conditions.

Note: Do not block patient circuit wye while in Stand-By state. If the wye is blocked, the ventilator detects a patient connection and will attempt to resume normal ventilation.

To enter Stand-By state

1. Touch the Menu tab on the left side of the GUI. The menu appears.

2. Touch Stand-By. A Stand-By state pending dialog appears instructing the clinician to disconnect the patient circuit. A timer starts which allows 30 s to disconnect the patient.

3. Disconnect the patient circuit and confirm the disconnection by touching Confirm. A timer starts which allows 30 s for confirmation of disconnect.

To exit Stand-By state

Reconnect the patient circuit. The ventilator resumes ventilation at the settings in use before the disconnection.

The following ventilator setting becomes active during Stand-By state:

• Base flow is set to ten L/min

During Stand-By state

• The exhalation valve is open.

• Current ventilator settings are retained in memory.

• Flow sensors are monitored to detect patient reconnection.

• Patient-related alarms are temporarily suppressed, as described.

• Ventilator settings can be changed, if desired, and will be applied upon patient reconnection.

• The ventilator displays an indicator that it is in Stand-By state, and a timer indicating the elapsed time the ventilator has been in Stand-By state.

• Ventilator background checks continue to be made.

The ventilator automatically exits Stand-By state when patient reconnection is detected, the clinician completes patient setup (if ventilation was mistakenly started before setup was complete), or the ventilator power is cycled.

Prior to entering Stand-By state, the ventilator measures pressure and flow in the patient circuit to determine if a patient is attached. If a patient is detected, the ventilator continues ventilation as set prior to the request, alerts the operator that Stand-By state is pending, and requests the patient be disconnected. A countdown timer appears alerting the operator of the time remaining to disconnect the patient. After the patient is disconnected, the ventilator requests confirmation of the disconnection. When the ventilator enters Stand-By state, a message appears on the GUI, any active alarms are muted and reset and the associated alarm reset entries are logged in the

Alarm Event Log. Alarm detection is suspended, and breath delivery is suspended while a bias flow is maintained for patient detection. During Stand-By state, the ventilator displays the elapsed time the patient has been without ventilation. Since the ventilator maintains a bias flow for patient detection, it resumes ventilation at the previous settings when the patient is reconnected. There is no need to touch Exit Stand-By. Reconnecting the patient returns the ventilator to normal operation. During Stand-By state, patient data values are not displayed and the

LED located at the top of the GUI cycles between yellow and green. Entry into and exit from Stand-By state is recorded in the General Event log.

3.7.4 Service Mode

Warning: Before entering Service mode, ensure a patient is not connected to the ventilator. Ventilatory support is not available in Service mode.

Service mode is used for extended self test (EST), ventilator calibration, configuration, software upgrades, option installation (all of which must be performed by a Covidien -trained service technician), and for making adjustments to institutional settings. All information stored in the individual logs is available in Service mode.

Service mode logs include:

• System diagnostic

• System Comm.

• EST/SST Diagnostic

• Settings

• Alarms

• General Event

• Service

• Patient data

See the Puritan Bennett 980 Series Ventilator Service Manual for details about Service mode logs.

A patient must not be attached to the ventilator when entering Service mode. Specific actions must be performed to enter this mode, prior to POST completion.

To access Service mode

1. Remove the ventilator from patient usage.

2. Turn the ventilator’s power switch on.

3. Press and release the Service mode button (TEST) at the back of the ventilator, when the Covidien splash screen appears on the status display after powering on the ventilator. See

Figure 31, page 77

. See Table 12, page 45

for an image of the splash screen. The ventilator prompts to confirm no patient is attached.

Figure 31.

Service Mode Button (TEST)

1 Service mode button

4. Wait to enter Service mode.

5. Confirm a patient is not connected to the ventilator by touching the corresponding button. The message

SERVICE MODE VENTILATION SUPPORT IS NOT AVAILABLE appears on the graphical user interface.

6. Perform the required service.

7. Turn off the ventilator to exit Service mode.

Note: The Covidien splash screen shows the Covidien logo and appears momentarily as a banner on the status display.

See the Puritan Bennett 980 Series Ventilator Service Manual for information on which keys are disabled during EST.

In addition to allowing SST to be run, Service mode also allows configuration of various items. See

Table 17, page 78

for a list of institutionally- and operator-configurable items.

3.8 Product Configuration

Warning: If the ventilator fleet in your institution uses multiple institutionally configured presets or defaults, there can be risks of inappropriate alarm settings.

The ventilator is shipped configured with factory defaults for new patient parameters can be configured to suit institutional preferences. The operator may configure any desired parameter as long as this option has not been locked out and rendered unavailable. When configuring the ventilator, it displays the parameters associated with the operator’s last configuration.

Table 17 lists the factory-configured settings, the institutionally-configurable

settings, and the operator-configurable settings.

Table 17.

Ventilator Configuration

Feature Factory-config‐ ured

X Vital patient data banner

Large font patient data panel

Waveform layout

Display bright‐ ness (Light set‐ tings)

Alarm volume

Elevate O

2 trol

con‐

Date/time for‐ mat

Default mL/kg ratio

New patient startup defaults

(including PBW, ventilation type, mode, manda‐ tory type, trigger type, O

2 vate O

)

%, ele‐

Opacity

Institutionally configurable

Operator-con‐ figurable

Configured by circuit type

User lockable

Can’t be changed in Nor‐ mal Mode

X X

3.8.1 Preparing the Ventilator for Use

Caution: Do not lean on the GUI or use it to move the ventilator. Doing so could break the GUI, its locking mechanism, or tip the ventilator over.

Prior to ventilating a patient, configure the GUI so it is capable of displaying all the desired parameters, information, and patient data. This eliminates the necessity for taking the patient off the ventilator, as configuration of many of the items requires the unit to be in Service mode.

To perform institutional configuration

1. Enter Service mode, and confirm no patient is attached by touching Configuration. See Section 3.7.4

for instructions on entering Service mode.

2. Touch Configuration at the top of the screen in Service mode. A list of buttons appears allowing configuration of the corresponding parameters.

3. See the next sections for specific instructions on institutional configuration of each parameter.

To return to factory default configuration

1. Enter Service mode, and confirm no patient is attached by touching Confirm. See Section 3.7.4, Service Mode, page 75

, for instructions on entering Service mode.

2. Touch Configuration at the top of the screen in Service mode. A list of buttons appears allowing configuration of the corresponding parameters.

3. Select the desired modified setting from the left-hand menu options.

4. Touch Default.

3.8.2 Configuring the GUI

The display can be configured in various ways. See Table 17, page 78

for the parameters which are factory configured, institutionally-configurable and operator-configurable. Once the factory or institutionally configurable items have been configured, they remain the default values. Factory configured values cannot be changed, however, if the parameters listed in the referenced table are institutionally configured, then those values remain in memory as default settings. If changes are made to operator-configurable parameters, they remain in memory during a ventilator power cycle as long as the same patient is set up when returned to ventilation. If a new patient is set up, the factory configured values or institutionally-configured values (if the parameter has been configured) are used. No alarm settings are institutionally configurable, which prevents changes to factory default alarm settings. However, the default mL/kg ratio is institutionally configurable, which can affect the default alarm setting values. Always review the alarm defaults prior to beginning ventilation, and set appropriately.

3.8.2.1 Date and Time Format

The date and time may be configured to the institution’s preference. The time can be specified as 12-hour or

24-hour time in HH:MM:SS format with 1-hour and 1-minute resolutions, respectively. The date formats are:

• DD-MMM-YYYY where DD is a two-digit day format, MMM is a three-letter abbreviation for the month, and

YYYY is a four-digit representation of the year

• MM-DD-YYYY where MM is a two digit month format, DD is a two-digit day format, and YYYY is a four-digit representation of the year

The settable date corresponds to the number of days in the set month and accounts for leap years.

To institutionally configure the ventilator’s date and time settings

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch Date and Time.

3. Touch the button corresponding to 12-hour or 24-hour time.

4. Touch Hour and turn the knob to enter the correct hour.

5. Repeat for the minutes, and am or pm.

6. Touch the button corresponding to the date format desired (DD-MMM-YYYY or MM-DD-YYYY).

7. Touch Accept to confirm the date and time.

8. If done configuring parameters, exit Service mode.

3.8.2.2 Pressure Units

The ventilator’s pressure units can be configured for hPa or cmH

To institutionally configure pressure units

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch the vent setup button.

3. Touch the button corresponding to the desired pressure units.

4. If done configuring parameters, exit Service mode by touching Exit .

3.8.2.3 Screen Brightness and Keyboard Backlight (Light Settings)

To institutionally configure screen brightness and keyboard backlight

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch Light Settings. Sliders appear to adjust the screen brightness and keyboard backlight.

3. Move the sliders to increase or decrease the brightness and backlight levels. Alternatively, turn the knob to increase or decrease the brightness and backlight levels.

4. Touch Accept to apply the changes, or Cancel to revert to original settings.

5. If done configuring parameters, exit Service mode.

To adjust display brightness

1. Press the display brightness key.

2. Slide the brightness slider or turn the knob to adjust the brightness level.

3. Dismiss the slider by touching anywhere on the GUI screen or allow to time out in 5 seconds.

Note: Keyboard backlight (bezel key brightness) can only be adjusted in Service mode.

3.8.2.4 New Patient Setup Defaults

To institutionally configure new patient default settings

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch the button corresponding to adult, pediatric, or neonatal new patient defaults.

3. Touch the Ventilation Type, Mode, Mandatory Type, and Trigger Type buttons corresponding to the desired parameters.

4. Configure the default PBW and mL/kg ratio, Elevate O

2 knob.

and O

% by touching its button and turning the

5. Repeat for each patient type by selecting the corresponding button.

6. Touch Accept or Accept ALL when the default configuration is complete.

7. If done configuring parameters, exit Service mode.

3.8.2.5 Elevate O

Note: The Elevate O

control adds a percentage of O in any value between 22% and 100% O

delivery.

to the breathing mixture for 2 minutes. The additional percentage is shown on the icon in the constant access icon area. The Elevate O

concentration can be set to result

To adjust the amount of elevated O

delivered for 2 minutes

1. In the vent setup dialog in Normal mode, touch the Elevate O

GUI screen.

icon in the constant access icons area of the

The icon glows and a dialog appears with a countdown timer, Elev O

2 changes, and Extend, Stop, and Close buttons.

button highlighted and ready for

2. Turn the knob to increase or decrease the amount of oxygen by the amount shown on the button. The allowable range can result in any value between 22% and 100% O

delivery.

3. Touch Extend to extend the 2-minute interval. Touching Extend restarts the 2-minute countdown timer.

4. Touch Stop to stop additional oxygen from being delivered and dismiss the countdown timer.

The Elevate O

function follows these rules:

• If apnea ventilation occurs during the 2-minute interval, the apnea % O

2 configured amount.

delivery also increases by the

• During LOSS OF AIR SUPPLY or LOSS OF O

SUPPLY alarm conditions, the Elevate O progress, and is temporarily disabled until the alarm condition no longer exists.

function is canceled if in

• During Safety PCV, the Elevate O

control has no effect. During circuit disconnect and Stand-By states (when the ventilator is turned on but not ventilating) the Elevate O concentration, not the set oxygen concentration.

function affects the currently delivered oxygen

3.8.2.6 Alarm Volume

Warning: The audio alarm volume level is adjustable. The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels.

To institutionally configure the alarm volume

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch Alarm Volume Defaults. A screen appears allowing configuration of the alarm volume by circuit type.

3. Slide the alarm slider for each circuit type (adult, pediatric, or neonatal) or turn the knob to configure the alarm volume. The volume settings range from 1 (minimum) to 10 (maximum).

4. If done configuring the alarm volume, exit Service mode.

To adjust alarm volume

1. Set the alarm volume by pressing the alarm volume key, then sliding the alarm volume slider or turning the knob.

The alarm values range from 1 (minimum) to 10 (maximum).

2. Dismiss the slider by touching anywhere on the GUI screen or allow to time out in 5 seconds.

Note: A sample alarm tone sounds for verification at each volume level change. If necessary, readjust the alarm volume by moving the alarm volume slider to increase or decrease the volume.

Note: The alarm volume reverts to the institutionally configured default alarm volume or factory default if the ventilator’s power is cycled.

3.8.2.7 Vital Patient Data

Patient data are displayed in the Vital Patient Data banner. The operator can configure the banner for displaying

the desired patient data. See Figure 32, page 94

. A total of 14 values may be configured at one time, with eight values visible, and six more visible by scrolling the values using the left- and right- pointing arrows in the patient data area.

Two pages of additional patient data may be viewed by touching or swiping down on the patient data tab at the top of the GUI. Choose the respective buttons to view page one or page two. Additional patient data values may not be changed.

To institutionally configure patient data displayed on the GUI

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch Patient Data Defaults. Five layout preset buttons appear along with a list of parameters and descriptions.

3. Touch a preset button and individually select a parameter from the scrollable list below to appear in that preset’s vital patient data banner. Use the right- and left- pointing arrows to configure default values for all available parameters. Additionally, touch the padlock icon above each patient data parameter on the data banner to allow (unlocked) or restrict (locked) operator configurablity of that parameter during normal ventilation.

4. When done configuring the selected preset, touch Accept and select another preset to configure, if desired.

5. Touch Defaults to return configuration to factory settings.

6. If done configuring parameters, exit Service mode by touching Exit.

To configure the patient data displayed on the GUI

1. Double-tap a patient data parameter at the top of the GUI screen. A menu of buttons appears identified with patient data parameters. The parameter at the location touched will be replaced with the new parameter of choice. To view more parameters, touch the left- or right- pointing arrows to reveal more parameters.

2. Touch the button corresponding to the replacement parameter. The existing parameter is replaced with the new parameter.

3. Repeat steps 1 and 2 for as many parameters as desired.

3.8.2.8 Displaying Patient Data With a Larger Font

To improve visibility of patient data, a screen is available that appears with a larger font. Up to 14 data values may be displayed which include:

• Institutional default patient data values (if configured)

• Remaining user selected patient data values (up to 14, including waveforms and loops)

To institutionally configure the large font patient data defaults

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch Large Font Patient Data Defaults. Five layout presets appear along with a list of parameters and descriptions.

3. Touch a preset button and individually select a parameter for each of the desired patient data values.

4. Choose the desired scalar and loop waveforms for the large font patient data display. Waveform thumbnails only appear in the three right-most cells of the large font data panel.

5. Touch any of the padlock icons along the right-most edge of the selected layout to prevent operator configurability of the selected row.

6. Touch Accept or Accept ALL when finished.

7. If factory defaults are desired for a preset, touch Defaults.

8. If done configuring parameters, exit Service mode by touching Exit.

To display the large font patient data panel

1. Swipe the vital patient data banner tab downward or touch the vital patient data tab. The additional patient data panel appears.

2. Swipe the additional patient data banner’s tab downward or touch the additional patient data banner’s tab.

Patient data appear in a larger font.

3. Swipe the large font patient data panel tab upward or touch the tab to return to the banner to its normal font size.

The large font patient data parameters are configured in the same way as described in the patient data configuration section.

3.8.2.9 Waveforms

Green waveforms denote a mandatory inspiration, yellow waveforms denote exhalation, and orange waveforms denote a spontaneous inspiration.

The GUI can be configured to display up to three waveforms and two loops simultaneously in the waveform area.

See

Figure 32, page 94 . The allowable waveforms include flow vs. time, pressure vs. time, and volume vs. time.

Allowable loops include pressure vs. volume and flow vs. volume. The waveforms display 60 seconds of information and can be shown in a redrawing format, or paused with the ability to enable a cursor to trace the waveform by turning the knob.

To institutionally configure waveforms and loops

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch Graph Defaults. Five layout presets appear along with a list of parameters and descriptions.

3. Touch a layout preset button. The parameter button outline glows, signifying that it can be changed. If more than one parameter can be changed, touch that parameter to make its outline glow.

4. Select the parameter from the list whose waveform is desired to appear on the waveforms screen.

5. Configure each of the graphic display layouts as described.

6. Touch the padlock icon above each graphic layout to prevent operator configuration of the selected layout.

7. If factory defaults are desired for a preset, touch Defaults.

8. If done configuring parameters, exit Service mode by touching Exit.

To configure waveforms and loops

1. Touch the waveform layout icon, located below the displayed waveforms or the vent setup screen.

The icon glows and a menu of various waveform layouts appears.

2. Touch the desired waveform icons to display. The selected waveforms appear on the GUI screen and the dialog closes.

To change the axis scaling

1. Touch the desired waveform axis.

2. Turn the knob to change the value. For each axis, turn the knob to the right to decrease the values, and turn to the left to increase the values.

To pause waveforms

1. Touch the pause icon, located below the waveforms area. The icon glows yellow and allows the breath to complete.

A cursor appears and travels along the waveform while turning the knob, displaying the x- and y-axis values.

2. Touch the pause icon again to re-activate the waveform.

See

Section 5.4.1, GUI Screen Capture, page 119

for information on storing waveforms.

3.8.2.10 Opacity

To institutionally configure screen opacity

1. Perform steps 1 and 2 in To perform institutional configuration of the

Section 3.8.1, Preparing the

Ventilator for Use, page 78

2. Touch the Opacity icon.

3. Turn the knob to increase or decrease the opacity.

4. Touch the padlock icon at the right side of the screen to allow or prevent operator adjustment of the screen opacity.

5. Touch Accept to close the dialog.

To adjust the screen opacity

1. Touch the opacity icon. The icon glows when the opacity can be changed.

2. Turn the knob to increase or decrease the opacity.

Note: The opacity icon can be found on the vent setup screen and on any of the respiratory mechanics maneuvers screens.

3.9 Installation Testing

Fully charge the batteries before placing the ventilator into clinical use. See

Section 3.3.2.3, Battery Charging, page 56

for information on battery charging. See Section 3.6.1, Primary Batteries, page 69 for the meaning of battery charge

status LEDs and Figure 27

for the location of battery test switch and status LEDs.

Prior to connecting a patient to the ventilator for the first time, a Covidien-trained service technician must have calibrated the ventilator’s exhalation valve, flow sensors, and atmospheric pressure transducer and performed and successfully passed EST. See the Puritan Bennett 980 Series Ventilator Service Manual for instructions.

In addition, the clinician must also perform SST.

3.9.1 SST (Short Self Test)

Warning: Always disconnect the patient from the ventilator prior to running SST or EST. If SST or EST is performed while a patient is connected, patient injury may occur.

Warning: Check for circuit occlusion or run SST if increased pressures are observed during ventilation.

Warning: When changing any accessories in the patient circuit or changing the patient circuit itself, run SST to check for leaks and to ensure the correct circuit compliance and resistance values are used in ventilator calculations.

Note: When extending ventilator circuits for neonatal patients, the resulting VBS compliance may trigger a

COMPLIANCE LIMITED V support (PS).

alarm such that the VC+ or VS software will not continue to update the pressure target during breath delivery. In this case the user can change the breath type to pressure control (PC) or pressure

When a patient is not attached to the ventilator, run SST to check the patient circuit for:

• Gas leaks

• Circuit compliance and resistance calculations

SST is a 5-minute test and must be run under any of the following conditions:

• Prior to ventilating a new patient

• When replacing the patient circuit and exhalation filter

• When connecting a different patient circuit to the ventilator

• When changing the patient circuit type

• When installing a new or sterilized exhalation filter

• When changing the humidification device type

• When adding accessories to or removing accessories from the breathing system (such as a humidifier or water trap)

No external test equipment is required, and SST requires minimal operator participation.

Humidification type and volume can be adjusted after running SST, however the ventilator makes assumptions when calculating resistance and compliance if these changes are made without re-running SST. For optimal breath delivery, run SST after changing humidification type and humidifier volume.

SST results are recorded in the SST results log, viewable in Service mode and in Normal mode using the configuration (wrench) icon.

3.9.1.1 Required Equipment

• Proposed patient circuit for patient ventilation

• Accessories (water traps, etc.)

• Exhalation filter and condensate vial

• Humidifier, if applicable

Other necessary items include:

• A no. 1 stopper to block the patient airway at the patient wye

• Two gas sources (air and oxygen) connected to the ventilator) at a pressure between 35 psi and 87 psi

(241.3 kPa and 599.8 kPa)

3.9.1.2 SST Test Sequence

To run SST

1. Ensure a patient is NOT connected to the ventilator.

2. So that the ventilator does not detect a patient connection, ensure that the breathing circuit wye is not attached to a test lung or covered in any way that would cause an increase in pressure at the wye.

3. Turn the ventilator on using the power switch located at the front of the BDU, below the status display. The ventilator runs POST when the power switch is turned on. Ensure the ventilator is operating on full AC power. Otherwise, SST test failures may result.

4. Wait at least 15 minutes to allow the ventilator to warm up and stabilize to ensure accurate results.

5. At the ventilator startup screen, touch SST or the Configure icon (wrench) displayed in the lower right area of the GUI.

The SST history log appears along with Patient Setup, Run leak Test, and Run ALL SST buttons.

6. Connect the patient circuit, filters, condensate vial, and all accessories to be used in patient ventilation.

Ensure the patient wye is not blocked.

7. Touch Run All SST to perform all SST tests or touch Run Leak Test to perform the SST Leak test of the ventilator breathing circuit.

8. Touch Accept to continue or Cancel to go back to the previous screen.

9. After accepting, touch the Circuit Type button corresponding to the patient circuit type used to perform

SST and to ventilate the patient (adult, pediatric, or neonatal).

10. Touch the Humidification Type button corresponding to the humidification type used for patient ventilation. If no humidifier is used, touch HME. If a humidifier is used, touch Humidification Volume and turn the knob to enter the volume. See

Table 19, page 86

for adult and pediatric patients or Table 20, page 87

for neonatal patients to determine the correct volume to enter.

11. Touch Accept to start SST.

12. Follow the prompts. Certain SST tests require operator intervention, and will pause indefinitely for a response. See

Table 21, page 87 for a summary of the SST test sequence and results.

13. After each test, the ventilator displays the results. If a particular test fails, the test result appears on the screen and a choice to repeat the test or perform the next test is given. When all of the SST tests are complete, the

SST status screen displays the individual test results.

14. To proceed to patient set up, (if SST did not detect an Alert or failure) touch Exit SST, then touch Accept or cycle the ventilator’s power.

Table 18 lists the tests performed during SST.

Table 18.

SST Test Sequence

Test step

SST Flow Sensor Cross Check

Test

SST Exhalation Valve Perform‐ ance

SST Circuit Pressure Test

Tests O

and Air Flow Sensors

Function

Calibrates the exhalation valve and creates a table for use during calculations

SST Leak Test

SST Exhalation Filter Test

SST circuit Resistance Test

SST circuit Compliance Test

SST Prox (if Proximal Flow option is installed)

Exercises delivery PSOL. Checks inspiratory and expiratory autozero solenoids.

Cross-checks inspiratory and expiratory pressure transducers at various pres‐ sures.

Tests ventilator breathing system for leaks

Checks for exhalation filter occlusion and exhalation compartment occlusion.

Checks for inspiratory and expiratory limb occlusions, and calculates and stores the inspiratory and expiratory limb resistance parameters.

Calculates the attached patient circuit compliance.

Verifies functionality of the proximal flow subsystem

Note: If you are running SST for a neonatal circuit with a humidifier, enter the volume listed in the shaded column

in Table 20

Table 19.

Humidifier Volumes for Adult and Pediatric Patients

Manufacturer

Fisher & Paykel

Model

MR225

MR290

MR250

Description

Ped, disposable, manual feed

Ped/adult disposable, autofeed

Adult, disposable, manual feed

SST humidifier volume

Setting (mL)

300

380

480

Table 19.

Humidifier Volumes for Adult and Pediatric Patients (continued)

Manufacturer

Fisher & Paykel

Teleflex (Concha)™*

AirLife™*

Model

MR210

MR370

382-10

AH290

Description

Adult, disposable, manual feed

Adult, reusable, manual feed

ConchaSmart

Disposable, autofeed

SST humidifier volume

Setting (mL)

480

725

300

380

Table 20.

Humidifier Volumes for Neonatal Patients

Manufacturer

Fisher & Paykel

Teleflex (Concha)™*

AirLife™*

Model

MR290

382-10

AH290

Description

Neo/adult disposable, autofeed

ConchaSmart

Disposable, autofeed

SST humidifier volume setting (mL)

550

390

520

a If the following neonatal patient circuits are used with a Fisher & Paykel MR850 humidifier, enter 500 mL as the humidifier volume: DAR neonatal patient circuit with single heated wire (DAR 307S9910)–for incubator use, DAR Neonatal patient circuit with single heated wire (DAR 307/8682)–not for incubator use.

Note:

For adult and pediatric patients, enter the humidifier volume shown in Table 19 . For neonatal patients, enter

the humidifier volume shown in

Table 20 .

3.9.1.3 SST Results

SST reports results for each individual test. Three status indicators identify the SST results and actions to take for each.

• Pass - The individual SST test has met its requirements.

• Alert - Alerts occur when the ventilator detects one or more non-critical faults.

• Fail - The individual SST test did not meet its requirements.

Table 21.

Individual SST Results

Pass

Alert

Test status

Failed

Meaning

Individual SST test passed

The test result is not ideal, but is not critical.

If SST is in progress, it halts further testing and prompts for decision.

The ventilator has detected a critical prob‐ lem and SST cannot complete until the ven‐ tilator passes the failed test.

Response

No need to do anything, unless prompted by the ventilator.

When the system prompts, touch one of these buttons:

• Repeat Test

• Next Test a

• Exit SST

Eliminate leaks in the ventilator breathing system and re-run SST. Otherwise, service the ventilator and re-run SST.

a WARNING—Completing SST with an Alert status for an individual test produces an Override SST button. Overriding an

Alert in SST may result in ventilator performance outside of the stated specification for accuracy. Choose to override the

Alert status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards. To override the alert, touch Override SST, then touch Accept.

3.9.1.4 SST Outcomes

When SST completes all of the tests, analyze the results.

Table 22.

Overall SST Outcomes

Final Outcome

PASS

OVERRIDDEN

FAIL

Meaning

All SST tests passed.

The ventilator detected one or more faults.

Choose to override the ALERT status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards.

One or more critical faults were detected.

The ventilator enters the SVO state and can‐ not be used for normal ventilation until SST passes.

Response

Touch Patient Setup to set up the patient for ventilation.

Check the patient circuit to determine the problem or restart SST with a different patient circuit.

If touching Override SST, observe the following warning:

Warning: Overriding an Alert in SST may result in ventilator performance outside of the stated specification for accuracy. Choose to override the ALERT status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards.

A single circuit leak test can be run without changing the SST outcome.

If a complete SST is interrupted and ventilation was allowed before starting SST, normal ventilation is allowed if all of the following conditions are met:

• SST did not detect any failures or alerts before the interruption.

• No other errors that would prevent ventilation occurred.

• There were no changes to the circuit type at the start of the interrupted SST.

During SST, the ventilator displays the current SST status, including the test currently in progress, results of completed tests. Test data are available in Service mode where applicable or are displayed on the screen. The ventilator logs SST results, and that information is available following a power failure. The audio paused and alarm reset keys are disabled during SST, as well as the manual inspiration, inspiratory pause, and expiratory pause keys.

3.9.2 Extended Self Test (EST)

The ventilator’s extended self test (EST) function is designed to verify the ventilator’s operational subsystem integrity.

All required software support to perform EST is resident on the ventilator. EST requires approximately 10 minutes to complete.

Note: SST is not part of the EST test suite. To determine patient circuit resistance and compliance, run SST.

3.9.2.1 EST Prerequisites

Follow all identified guidelines when performing the EST self test. Inspect all equipment required for any self test to ensure it is not damaged in any way.

1. Collect all required equipment prior to performing any self test of the ventilator. Successful self test is not possible without the use of the listed equipment.

2. Disconnect the ventilator from the patient.

3. Fully charge the primary ventilator battery.

4. Connect the ventilator to AC power using the hospital-grade power cord until completion of any self test.

5. Ensure the ventilator is powered down.

6. Ensure both air and oxygen sources register pressure between 241 kPa and 599 kPa (35 psi and 87 psi).

To perform EST or to access additional service functions, the ventilator must be in Service mode. See

Section 3.7.4,

Service Mode, page 75 .

Note: While in the Service mode, normal ventilation is not allowed.

Warning: Always disconnect the ventilator from the patient before running EST. Running EST while the ventilator is connected to the patient can injure the patient.

Warning: A fault identified during this test indicates the ventilator or an associated component is defective.

Rectify the fault and perform any required repairs prior to releasing the ventilator for patient use, unless it can be determined with certainty that the defect cannot create a hazard for the patient, or add to the risks which may arise from other hazards.

Perform EST during any of the listed conditions.

• Prior to initial installation and first time usage of the ventilator

• Every 12 months

• Before any preventive maintenance

• Following ventilator service or repair

• As part of the ventilator’s routine performance verification

During EST, the ventilator displays the current EST status, including the test currently in progress, results of completed tests, and measured data (where applicable). The ventilator logs EST results, and that information is available following a power failure. The ventilator disables several offscreen keys located on the bezel of the GUI during EST.

• Audio paused

• Alarm reset

• Manual inspiration

• Inspiratory pause

• Expiratory pause

Run tests either as a group or as single tests for troubleshooting purposes.

3.9.2.2 Equipment for EST

1. Covidien gold standard test circuit.

2. Number 1 stopper.

3. Air and oxygen sources, both at 35 to 87 psi (241 to 599 kPa).

4. An adult-sized exhalation filter.

Note: Attempts to run EST with a Neonatal filter can cause some EST tests to fail.

Note: If using Air Liquide™, Dräger™, and SIS air and oxygen hose assemblies, certain EST tests may fail when using supply pressures less than 50 psi (345 kPa) based on excessive hose restriction.

3.9.3 EST Test Sequence

Note: If the ventilator has not reached normal operating temperature from recent usage, allow it to warm up for at least 15 minutes in Service mode prior to running EST to ensure accurate testing.

To perform EST

1. Review and perform all self test prerequisites. See

Section 3.9.2.1, EST Prerequisites, page 88

2. Collect the appropriate equipment. See

Section 3.9.2.2, Equipment for EST, page 89

3. Access Service mode. See Section 3.7.4, Service Mode, page 75 .

4. Verify all calibration tests under the Calibration tab have passed.

5. Touch the Self Test tab from the horizontal banner at the top of the monitoring screen.

6. Touch the EST tab from the left-hand menu options.

7. Touch Run All to run all tests in sequence or select the desired individual test.

8. Choose one of the available options: touch Accept to continue; touch Cancel to go back to the previous screen; or touch Stop to cancel EST.

9. Follow the prompt to remove the inspiratory filter and connect the gold standard circuit.

10. Touch Accept.

11. Follow prompts to complete EST. The EST tests require operator intervention, and will pause indefinitely for a response. See

Section 3.9.3, EST Test Sequence, page 89

12. At the Disconnect O

prompt, disconnect the high pressure oxygen source.

13. At the Disconnect air prompt, disconnect the high pressure air source.

14. At the Connect air and O

prompt, connect both high pressure air and oxygen sources.

15. Touch Run All or select the desired individual test. After each test, the ventilator displays the results.

16. If a particular test fails, either repeat the test or perform the next test.

17. When all of the EST tests complete, review test results by pressing each individual test listed on the left side of the GUI.

18. At the top of the GUI, touch Exit.

19. Touch Confirm at the prompt to return to normal ventilation mode. The ventilator reruns POST and then displays the ventilator startup screen.

Table 23.

EST Test Sequence

EST Test Step

Zero Offset

Function Required User

Interaction

Follow prompts

Leak Test

Mix Leak

Mix PSOL

Mix Accumulator

Circuit Pressure

Tests inspiratory and expiratory pressure transducers and flow sensors at ambient pressure.

Determines ability of system to hold pressure.

Verifies integrity of the mix system.

Verifies mix PSOL function.

Verifies mix accumulator pressure sensor and overpressure switch function.

• Checks inspiratory and expiratory autozero solenoids

• Cross-checks safety valve, inspiratory and expiratory pressure transducers at various pressures

• Verify the autozero solenoid’s function

Verifies all flow sensors and PSOLs at specified flow volumes.

Follow prompts

None

None Flow Sensor Cross

Check Test

Delivery PSOL

Exhalation Valve (EV)

Loopback

Exhalation Valve (EV)

Pressure Accuracy

Exhalation Valve (EV)

Performance

Exhalation Valve (EV)

Velocity Transducer

Safety System

Verifies delivery PSOL current function.

Verifies exhalation valve current and loopback current are within range.

Verifies current versus pressure values in flash memory correspond with actual installed exhalation valve.

Verifies the exhalation valve operates within specifications of the last exhalation valve calibration.

Verifies the velocity transducer is sending a signal and the control circuit recognizes it. It does not verify the quality of the signal.

Tests safety valve operation.

None

Table 23.

EST Test Sequence (continued)

EST Test Step Function

Backup Ventilation Verifies backup ventilation systems: mix, inspiratory, and exhala‐ tion.

Communication Verifies GUI communication ports function, both serial and ether‐ net.

Internal Storage

LCD Backlight

Status Display

Verifies internal storage device function.

Verifies GUI LCD backlight intensity function.

• Verifies status display function

• Verifies LCD function

• Communicates with BDU CPU

• Communicates with compressor, if installed

GUI Alarms

BD Alarms

Tests GUI alarm indicators, cycling through each alarm status indi‐ cation.

Verifies BD audible alarm is functional. Also verifies power fail capacitor can operate the LOSS OF POWER alarm.

Rotary Knob Test Verifies knob rotation function.

Offscreen Key Test Verifies GUI bezel key function.

Ventilatory Battery Tests ventilator battery and power distribution.

Run only if compressor installed

Compressor Battery Tests compressor battery function, as well as compressor power system and fan function.

Compressor Tests overall compressor operation: pressure transducer, fan, motor, and pressure relief valve.

Compressor Leak Checks compressor system for leaks.

Compressor Per‐ formance

Tests compressor operational performance under load.

Required User

Interaction

None

Follow prompts

None

3.9.4 EST Test Results

Table 24.

EST Test Step Results

Pass

Test Status

ALERT

Failed

Meaning

Individual EST test passed

The test result is not ideal, but is not critical.

If EST is in progress, it halts further testing and prompts for decision.

EST not successfully passed.

Response

No need to do anything unless prompted by the ventilator

When the system prompts, select:

Repeat Test,

Next Test

a ,

Stop then touch Accept.

Select:

Repeat Test,

Next Test, or

Stop,

Table 24.

EST Test Step Results (continued)

Test Status Meaning Response then touch Accept.

Run all EST tests.

NEVER RUN Test still requires successful PASS.

a WARNING—Completing EST with an ALERT status for an individual test produces an Override EST button. Choose to override the ALERT status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards. To override the alert, touch Override EST, then touch Accept.

When EST completes all of the tests, analyze the results.

Table 25.

Overall EST Outcomes

Final Outcome

PASSED

OVERRIDDEN

FAIL

Meaning

All EST tests passed

ALERT status overridden by user.

One or more critical faults were detected.

The ventilator enters the SVO state and can‐ not be used for normal ventilation until SST passes. Service is required.

Response

EST successfully completed. Select other

Service mode functions or prepare for SST tests prior to returning the ventilator for patient usage.

Repair the ventilator and rerun EST.

Touching Override EST results in the following warning:

Warning: Choose to override the ALERT status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards.

3.10 Operation Verification

Before ventilating a patient, you must perform SST and alarms tests with passing results . See

Section 3.9.1.2,

SST Test Sequence, page 85 . See

Section 6.5.5, Alarm Testing, page 140 as well.

4 Operation

4.1 Overview

This chapter describes Puritan Bennett 980 Series Ventilator operation and includes the following sections:

• Setting up the ventilator

• How to use the ventilator

• How to use the ventilator’s graphical user interface (GUI)

• How to set or change main, alarm, or apnea settings

• How to test alarms

• How to calibrate, enable, or disable the O

sensor

• How to perform inspiratory and expiratory pause maneuvers.

• How to use non-invasive ventilation (NIV)

4.2 Ventilator Function

Air and oxygen from wall sources, cylinders, or the optional compressor enter the ventilator and flow through individual oxygen and air flow sensors. The gases are then mixed in the mix module’s accumulator. A pressure-relief valve in the mix module’s accumulator prevents over-pressurization. The mix module also contains an oxygen sensor which monitors the air-oxygen mixture according to the operator-set O

% setting.

After the gas mixes, it flows to the inspiratory pneumatic system, where the breath delivery flow sensor measures the gas flow and controls a PSOL valve for proper breath delivery tidal volumes and pressures. The inspiratory pneumatic system contains a safety valve to avoid over-pressure conditions before flowing through bacteria filters to the patient through the inspiratory limb of the patient circuit. Upon exhalation, gas flows out the patient circuit expiratory limb, through the exhalation bacteria filter, through the exhalation valve, which includes the exhalation flow sensor, and through the exhalation port.

4.3 Ventilator Setup

Warning: To avoid interrupted ventilator operation or possible damage to the ventilator, always use the ventilator on a level surface in its proper orientation.

To set up the ventilator

1. Connect the ventilator to the electrical and gas supplies. See Figure 15

, Figure 16 and

Figure 17

2. Connect the patient circuit to the ventilator. See Figure 24, page 67

and

Figure 25, page 68 to connect the

adult/pediatric or neonatal patient circuits, respectively.

3. Turn the ventilator on using the power switch.

4. Before ventilating a patient, run SST to calculate the compliance and resistance with all items included in the patient circuit. See

Section 3.9.1.2, SST Test Sequence, page 85 .

4.4 User Interface Management

The user interface is structured with a GUI and a status display. The GUI provides access to ventilator controls and patient data. The status display is a small LCD panel which acts as a back up to the GUI in the event of a GUI failure.

See

Section 2.11.1.3, Status Display, page 43

for more information about the status display.

The status display is not interactive.

During normal ventilator operation, the following information appears on the status display:

• Current power state (AC or DC)

• Batteries installed / charge status (BDU and compressor, if present)

• Visual indication of audible alarm volume

• Circuit pressure graph displaying P

PEAK

, PEEP, and pressure-related alarm settings

4.4.1 Using the GUI

The GUI is used to interact with the ventilator while it is ventilating a patient or in any of its operating modes.

Caution: Do not lean on the GUI or use it to move the ventilator. Doing so could break the GUI, its locking mechanism, or tip the ventilator over.

The GUI is divided into several areas.

Figure 32.

Areas of the GUI

Prompt area - Located beneath the waveforms. Any prompts or messages related to soft or hard bounds display here. A soft bound is a selected value that exceeds its recommended limit and requires acknowledgment to continue. Hard bounds have minimum and maximum limits beyond which values cannot be selected, but if the desired value is equal to a settings hard bound, then it is allowable.

Menu tab - Located on the left side of the GUI screen. Swiping the tab to the right and touching Setup causes the Vent, Apnea, and Alarm tabs to appear. Touching those tabs opens screens so that changes to ventilator settings, apnea settings and alarm settings can be made.

Waveform area - Located in the center of the GUI screen. Shows various breath waveforms. See

Section 3.8.2.9, Waveforms, page 83

for information on how to configure graphics.

Breath phase indicator - During normal ventilation, the GUI displays a breath indicator in the upper left corner which shows the type of breath [Assist (A), Control (C), or Spontaneous (S)] currently being delivered to the patient, and whether it is in the inspiratory or expiratory phase. The breath indicator is updated at the beginning of every inspiration, and persists until the next breath type update. During inspiration, assist (A) and control (C) breath indicators glow green and spontaneous (S) breath indicators glow orange, each appearing in inverse video where the indicator appears black surrounded by the colored glow. See

Figure 32, page 94

. During the expiratory phase the breath indicators appear as solid colors (green during assist or control breaths and orange during spontaneous breaths).

Vital patient data banner - Located across the top of the GUI screen. The patient data banner displays monitored patient data and can be configured to show desired patient data. See

Section 3.8.2.7, Vital Patient

Data, page 81 for information on configuring patient data for display.

Alarm banners - Located on the right side of the GUI screen. Indicates to the operator which alarms are active, and shown in a color corresponding to priority (high is red and flashing, medium is yellow and flashing, low is yellow and steady).

Constant access icons - Located at the lower right of the GUI screen. This area allows access to home

(house), configure (wrench), logs (clipboard), elevate oxygen percentage (O

), and help (question mark) icon. These icons are always visible regardless of the function selected on the GUI.

Constant access area - Consists of the current settings area and the constant access icons. This area allows access to any of the patient setup variables shown in these areas. Touching an icon causes the particular menu for that variable to appear.

Current settings area - Located at the lower center of the GUI screen. The ventilator’s current active settings display here. Touching any of the current settings buttons causes a dialog to appear, allowing changes using the knob.

10.

Vent setup button - Located at the lower left of the GUI screen. Touching this button allows access to the ventilator setup screen.

4.4.2 Adjusting GUI Viewing Properties

4.4.2.1 Screen Opacity

The opacity control enables the operator to adjust the opacity of the displayed information between

50% and 100%. At 50%, the displayed image is semi-transparent, and at 100%, the displayed image is opaque. The opacity value remains as set if power is cycled. See

Section 3.8.2.10, Opacity, page 84 for

instructions on adjusting this feature.

4.4.2.2 Pushpin Feature

The pushpin feature prevents a dialog from closing under certain conditions. Like the opacity control, the pushpin appears on the settings screen after a new patient starts ventilation.

Figure 33.

Pushpin Icon – unpinned state

Figure 34.

Pushpin Icon – pinned state

To use the pushpin

1. When a dialog is open, for example, if Accept or Accept ALL buttons are available, touch the unpinned pushpin icon to pin the dialog and hold it open.

2. Touch Close to close the dialog.

4.4.2.3 Display Brightness

Display brightness can be controlled manually. This feature is institutionally configurable. See

Section 3.8.2.3,

Screen Brightness and Keyboard Backlight (Light Settings), page 80 . The brightness range is from 1% to 100% with 1%

resolution. The default value is 80%.

To manually adjust display brightness

1. Press the display brightness key.

2. Slide the brightness slider to the right to increase the brightness level or to the left to decrease the brightness level. Alternatively, turn the knob to increase or decrease the brightness level. The control disappears from the screen in approximately 5 seconds.

4.4.2.4 Display Lock

The primary display provides a display lock key to prevent inadvertent changes to settings. When active, the display lock disables the touch screen, knob, and off-screen keys and illuminates an LED on the display bezel. An image of the display lock icon appears transparently over anything displayed on the GUI, should the operator attempt to use the GUI. Any new alarm condition disables the display lock and enables normal use of the GUI.

To lock and unlock the display

1. Press the display lock key on the GUI.

The keyboard LED illuminates and a transparent icon appears on the screen, indicating display lock. The icon shortly disappears, but if the operator tries to activate any of the touch screen controls, the icon re-appears.

2. To unlock the display, press the display lock key again. The display lock LED turns off.

4.4.3 Using Gestures When Operating the GUI

The GUI incorporates a gesture-based interface where features can be actuated with the fingers using different

motions. Table 26

explains gestures used with the GUI.

Table 26.

Gestures and Their Meanings

Gesture

Swipe

Description

Quickly brush the screen surface with the fingertip.

Used for

Opening or closing dia‐ logs or panels that slide in and out from the screen sides or top, moving wave‐ form data, expanding or collapsing tooltips, scroll‐ ing lists, or alarm banners, maximizing or minimizing waveforms.

Double-tap

Rapidly touch the screen surface twice with one finger.

Maximizing or minimizing the viewable area of a dia‐ log, control, or waveform,

How to use

Swipe toward the center of the screen to open dialogs or panels. Swipe toward the side of the screen (or upward if viewing the additional patient data or large font patient data panels) to close. To move a paused waveform, swipe in the desired direction.

Swipe upward anywhere on a waveform to maximize it, and swipe downward on the maximized waveform to minimize it. Swipe a tooltip upward to expand to a long description and downward to collapse to a short description. A downward swipe any‐ where in the patient data area opens the additional patient data panel, and another swipe on the additional patient data tab displays the large font patient data panel.

Double-tapping maximizes the viewable waveform area or shows the long descrip‐ tion of a tooltip. Double-tapping again min‐ imizes the viewable waveform area or

Table 26.

Gestures and Their Meanings (continued)

Gesture

Drag

Touch and hold

Drag and drop

Description

Move the fingertip over the screen sur‐ face without losing contact.

Used for expanding or collapsing tooltips

Changing x- and y- axis scales, moving the wave‐ form cursor, moving scroll‐ bars, scrolling lists. Scroll‐ ing speed varies depend‐ ing upon how far outside the list boundary the fin‐ ger is positioned.

Touch an item and hold for at least 0.5

second.

Touch and drag an item to another loca‐ tion and lift finger to drop.

Displaying a tooltip dialog on whatever item is touched. The tooltip appears to glow indicat‐ ing the touch and hold action.

Dragging help icon to describe an onscreen item.

How to use shows the short description of a tooltip. If the control is configurable, double tapping produces the configuration pop-up menu.

Touch the axis and drag to the right to increase the waveform x-axis scale, and to the left to decrease. Touch the axis and drag upward to increase the y-axis scale and downward to decrease. To move the cursor

(when the waveform is paused), touch the cursor and drag it right or left. The graph responds similarly. Scroll a list by dragging the scrollbar right or left or up or down. The list scrolls according to the direction of the finger movement. An automatic scrolling feature starts if the finger is dragged from the inside of a list to outside its boundary.

The farther outside the boundary the finger is dragged, the faster the list scrolls.

N/A

Drag the help icon, located at the lower right of the GUI screen, to the item in ques‐ tion and drop. If a blue glow appears, a tool‐ tip is available and appears with informa‐ tion about that item (for example, a control or symbol).

4.5 Ventilator Operation

Warning: Prior to patient ventilation, select the proper tube type and tube ID.

Caution: Do not set containers filled with liquids on the ventilator, as spilling may occur.

After turning on the ventilator it will display a “splash screen,” and run power on self test (POST). After the splash screen appears, the ventilator gives a choice to ventilate the same patient or a new patient, or run SST.

Ventilation parameters are entered via the GUI using the following general steps:

1. Touch the setting displayed on the GUI.

2. Turn the knob to the right to increase or to the left to decrease the value.

3. Touch Accept to apply the setting or Accept ALL to apply several settings at once.

Note: Quick Start allows for rapid setup and initiation of mechanical ventilation. Review Quick Start parameters and ensure they are consistent with institutional practice before using this feature.

To use Quick Start

1. Touch New Patient.

2. Touch the highlighted PBW button or Gender/Height.

3. Turn the knob to adjust the patient’s PBW or gender and height (if gender is selected, the height selection becomes available).

4. Touch Quick Start.

5. Connect the circuit wye adapter to the patient’s airway or interface connection. The patient is ventilated with the institutionally configured Quick Start defaults according to the PBW or gender and height entered, and circuit type used during SST. There is no prompt to review the settings and the waveforms display appears.

Note: Connecting the circuit wye adapter to the patient’s airway or interface connection prior to making the ventilation settings causes the ventilator to begin ventilation using safety Pressure Control Ventilation (Safety PCV) and annunciate a PROCEDURE ERROR alarm. As soon as the ventilator receives confirmation of its settings (by touching Accept or Accept ALL ), it transitions out of safety PCV, resets the alarm, and delivers the chosen settings.

See

Table 54, page 239 for a listing of these settings.

To resume ventilating the same patient

1. Touch Same Patient on the GUI screen. The previous ventilator settings are displayed on the screen for review prior to applying the settings to the patient.

2. If the settings are acceptable, touch Accept to confirm. To change any settings, touch the setting, turn the knob clockwise to increase the value of the setting or counter-clockwise to decrease the value of the setting, and touch Accept to confirm. To make several settings changes at once, make the desired changes, then touch Accept ALL to confirm. The appearance of the settings changes from white, non-italic font showing the current setting to yellow italics (noting the pending setting). After the settings are accepted, the appearance changes back to white non-italic font.

3. Connect the circuit to the patient’s airway to initiate ventilation.

To ventilate a new patient

1. Touch New Patient on the GUI screen. The New Patient settings screen appears to enter the ventilation

control parameters. See Table 64 for default ventilator parameter settings.

Figure 35.

New Patient Settings

2. Enter the patient’s PBW or gender and height (if gender is selected, the height selection becomes available).

3. If the default ventilator settings are appropriate for the patient, touch START to confirm the settings, otherwise, touch a ventilator setting and turn the knob to adjust the parameter. Continue this process for all parameters needing adjustment.

4. Touch Accept or Accept ALL to confirm the changes.

5. Connect the circuit to the patient’s airway to start ventilation.

4.5.1 Ventilator Settings

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

The following ventilator settings appear at the new patient setup screen:

• Predicted Body Weight (PBW) — Adjust the patient’s PBW, or select the patient’s gender and height. See

Section 4.6, Predicted Body Weight (PBW) Calculation, page 106 .

• Ventilation type — Determines the type of ventilation to be delivered [Invasive or Non-invasive (NIV)]

– Invasive — Conventional ventilation using endotracheal (ET) or tracheostomy (trach) tubes.

– Non-invasive (NIV ) — Ventilation using non-vented full-face masks, nasal masks, infant nasal prongs, or

uncuffed ET tubes. See Section 4.7, Non-invasive Ventilation (NIV), page 107

• Mode — Specify the breathing mode (A/C (assist/control), SIMV (synchronous intermittent mandatory ventilation), SPONT (spontaneous ventilation), BiLevel, or CPAP

• Mandatory type — Select PC (pressure control), VC (volume control), or VC+ (volume control plus)

• Spontaneous type — If SIMV or BiLevel was selected as the mode, specify PS (pressure support) or TC (tube compensation). If SPONT was selected as the mode, specify PS (pressure support), TC (tube compensation), or VS (volume support), or PAV+™ (proportional assist ventilation).

Note: VS, PAV+™, and TC are only available during Invasive ventilation.

• Trigger type — Select pressure- triggering (P-Trig) or flow-triggering ( ⩒ -Trig). Pressure-triggering is not available when ventilation type is NIV. If ventilating a neonatal patient, only flow-triggering is available

Other ways to access the vent setup screen:

• Touch the vent setup button at the bottom left of the GUI display

• Swipe the menu tab on the left side of the GUI and touch Setup

Figure 36.

Open Menu Tab

1 Setup button

Figure 37.

New Patient Setup Screen

To enter settings into the ventilator

1. Select Ventilation Type, Mode, Mandatory type, Spontaneous type and Trigger type by touching the corresponding button.

2. Touch the ventilator setting button needing changes.

3. Adjust the setting value.

4. Continue in this manner until all changes are made, then touch Accept or Accept ALL .

100

5. Touch START. Ventilation does not begin until the breathing circuit is connected to the patient’s airway. After

ventilation begins, waveforms begin plotting on the displayed waveforms axes. See Section 3.8.2.9,

Waveforms, page 83

for information on setting up the graphics display.

If changes to any settings are required, return to the vent setup screen as described.

Note: A yellow triangle icon appears on tabs and buttons displayed on the GUI containing unread or unviewed items. When the item containing the icon is touched, the icon disappears.

Note: To make any settings changes after completing patient setup, touch the Vent tab on the left side of the

Setup dialog and make settings changes as described. The current setting appears in white font and changes to yellow italics to note the new value is pending. Touch Accept or Accept ALL to confirm a single change or a batch of changes. Once the settings are accepted, their appearance changes to white font.

Note: Selecting Quick Start, Accept , Accept ALL or Start from the setup dialog implements all settings in ALL four setup tabs (Vent Setup, Apnea, Alarms, and More Settings) and dismisses the setup dialog.

4.5.1.1 Tube Compensation

Tube compensation (TC) is a spontaneous type selected during ventilator setup. It allows the ventilator to deliver

additional positive pressure to overcome the resistance imposed by the patient’s artificial airway. See Figure 37, page 100 for more information on setting up the ventilator. See

Section 4.5.1

for details of specific tube

compensation settings.

To enable TC

1. Touch the Vent tab on the GUI screen. See

Figure 37 .

2. Touch SPONT for the Mode selection.

3. Touch TC for Spontaneous Type.

4. Finish setting up the ventilator as described see

Figure 37, page 100 for information on entering ventilator

settings.

5. Ensure to select the tube type (either endotracheal or tracheostomy) and set the tube ID to correspond to patient settings.

6. After making the changes, touch Accept to apply the new settings, or Cancel to cancel all changes and dismiss the dialog.

4.5.1.2 Adjust Tube Type, Tube ID, and Humidification

Warning: To prevent inappropriate ventilation with TC, select the correct tube type (ET or tracheostomy) and tube inner diameter (ID) for the patient’s ventilatory needs. Inappropriate ventilatory support leading to over-or under-ventilation could result if an ET tube or trach tube setting larger or smaller than the actual value is entered.

To select new settings for the tube, follow these steps

1. Touch Vent Setup on the GUI screen to display the ventilator setup screen.

2. Touch Tube Type or Tube ID for the value to be changed.

3. Turn the knob to change the setting.

4. Make other tube settings, as necessary.

5. Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel all changes and dismiss the dialog.

Note: The tube type and tube ID indicators flash if TC is a new selection, indicating the need for entry of the correct tube type and tube ID.

101

To select new settings for the humidifier, follow these steps

1. From the ventilator setup screen, touch the More Settings tab. A dialog appears containing selections for humidifier type and volume.

Note: A Humidification Volume button appears below the selection only if Non-heated Expiratory Tube or

Heated Expiratory Tube is selected as the humidifier type.

2. Turn the knob to enter a value equal to the dry volume of the humidifier chamber being used.

3. Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel all changes and dismiss the dialog.

Table 27 lists the allowable ventilator settings according to patient type and ventilation type.

Table 27.

Allowable Ventilator Settings

Patient type

Ventilation type

Mode

Mandatory type

Invasive

A/C, SIMV,

SPONT, BiLe‐ vel

PC, VC, VC+

Adult

A/C, SIMV,

SPONT

PC, VC

Spontane‐ ous type

PS, TC, VS,

PAV+™

(≥25 kg)

Trigger type ⩒ -Trig, P-Trig ⩒ -Trig

NIV

Pediatric

Invasive

A/C, SIMV,

SPONT, BiLe‐ vel

PS, TC,

(≥7.0 kg), VS

NIV

A/C, SIMV,

SPONT

PC, VC, VC+ PC, VC

Neonatal

Invasive

A/C, SIMV,

SPONT, BiLe‐ vel

A/C, SIMV,

SPONT, CPAP

PC, VC, VC+ PC, VC

PS, VS PS

NIV

⩒ -Trig, P-Trig ⩒ -Trig ⩒ -Trig ⩒ -Trig

Note: To use neonatal ventilator settings, the NeoMode 2.0 software option must be installed on the ventilator, or a Puritan Bennett 980 Neonatal Ventilator must be in use.

4.5.2 Apnea Settings

After making the necessary changes to the ventilator settings touch the Apnea tab on the left side of the setup dialog. Although changing the apnea settings is not required, confirm the default settings are appropriate for the patient. Apnea ventilation allows pressure control or volume control breath types. Parameters in pressure-controlled apnea breaths include f, P f, V

, ⩒

MAX,

Flow pattern, O

%, and T

, T

%, and T

. Volume-controlled apnea breath parameters are

Note: If Quick Start is chosen, and the apnea tab on the vent setup screen shows a yellow triangle, indicating the apnea settings have not been reviewed.

102

Figure 38.

Apnea Setup Screen

To set apnea parameters

1. Select the desired apnea breath type (PC or VC).

2. Enter the desired apnea settings in the same manner as for the ventilator settings.

3. Touch Accept or Accept ALL to confirm apnea settings.

During apnea pressure ventilation, apnea rise time% is fixed at 50%, and the constant parameter during a respiratory rate change is T .

4.5.3 Alarm Settings

After accepting the apnea settings, the display returns once more to show the waveforms. Return to the Vent

Setup dialog and touch the Alarms tab on the left side of the GUI screen. The alarms screen appears with the default alarm settings. See

Figure 39, page 104 . Review and adjust the alarm settings appropriately for the patient.

Note: If Quick Start is chosen, the alarms tab on the dialog shows a yellow triangle, indicating the alarm settings have not been reviewed.

Note: The default alarm settings cannot be changed. The clinician can adjust alarm settings by following the

procedure described in the task below Figure 39, page 104 . The alarm settings are retained in memory when the

ventilator’s power is cycled and same patient is selected. Otherwise, current settings revert to new patient defaults when a new patient is selected.

103

Figure 39.

Alarms Settings Screen

To adjust the alarm settings

1. Touch each alarm setting slider of the alarms to change. Alarm settings are available for P

PEAK

, f

TOT

MAND

, V

TE SPONT

, and V

parameters.

, ⩒

E TOT

, V

2. Turn the knob clockwise to increase the value, or counter-clockwise to decrease the value.

3. Continue until all desired alarms are set as necessary.

4. Touch Accept ALL to confirm the alarm settings.

Note: There is an additional alarm setting for TC, PAV+™, VS, and VC+ breath types: high inspired tidal volume

( ⤒ V

). This alarm condition occurs when the inspired tidal volume is larger than the setting value. A ↑ V

alarm will also cause breath delivery to transition to the expiratory phase to avoid delivery of excessive inspiratory volumes.

Warning: Prior to initiating ventilation and whenever ventilator settings are changed, ensure the alarm settings are appropriate for the patient.

Warning: Setting any alarm limits to OFF or extreme high or low values, can cause the associated alarm not to activate during ventilation, which reduces its efficacy for monitoring the patient and alerting the clinician to situations that may require intervention.

See

Section 3.8.2.6, Alarm Volume, page 81

to ensure alarm volume is adjusted properly.

Note: A sample alarm tone sounds for verification at each volume level change. Readjust the alarm volume by moving the alarm volume slider to increase or decrease the alarm volume.

Note: Do not block the patient wye while the ventilator is waiting for a patient connection. Otherwise the blockage could imitate a patient connection.

4.5.4 Alarm Screen During Operation

During ventilator operation, the alarm screen appears with indicators to let the operator know the current patient

data value for each parameter Figure 40 (item 1), the parameter alarm settings Figure 40 (items 2 and 3), recent range of patient data values for the last 200 breaths Figure 40 (item 4). If an alarm occurs, the slider and

corresponding limit button show a color matching the alarm’s priority.

104

Figure 40.

Alarm Screen during Operation

1 Pointers show current value of patient data corresponding to the alarm parameter

2 High alarm setting (in this case ⤒ V

TE SPONT

)

3 Low alarm setting (in this case ⤓ V

TE SPONT

)

4 Range of patient data values for the particular parameter during the last 200 breaths

4.5.5 Making Ventilator Settings Changes

If, during ventilation, settings changes are necessary that don’t involve changes to PBW, mode, breath types, or trigger types, the current settings area located at the lower portion of the GUI screen can be used. See

Figure 32, page 94

for the location of the current settings area.

To change a ventilator setting using the “current settings” area

1. In the current settings area, touch the parameter whose value needs to be changed. A dialog appears containing buttons for all ventilator settings, with the selected setting highlighted.

2. Touch and turn the knob for any other settings that need to be changed.

3. Touch Accept or Accept ALL .

To change a setting using the vent setup button

1. Touch the vent setup button.

2. Change the settings as described.

3. Touch Accept or Accept ALL to confirm the changes

The ventilator settings and the alarm settings chosen remain in memory after a power cycle, as long as the same patient is chosen when the ventilator is set up again. If a new patient is being ventilated, the ventilator and alarm settings revert to their default values. If all power is lost (both AC and battery), the ventilator and alarm settings in effect prior to the power loss are automatically restored if the power loss duration is 5 minutes or less. If the power loss lasts longer than 5 minutes, ventilation resumes in safety PCV. Ventilator and alarm settings must be reset for

the patient being ventilated. See Table 54, page 239 for a list of these settings.

To use the Previous Setup button

105

1. To return to the previous setup, touch the vent setup button then touch Previous Setup on the GUI screen.

The ventilator restores the main control and breath settings previously used, as well as the alarm and apnea settings, and prompts a review by highlighting the previous values in yellow. The ventilator, alarm, and apnea settings tab text is also shown in yellow and the tabs show a yellow triangle, indicating there are previous settings that have not been reviewed.

2. If the settings are acceptable, touch Accept or Accept ALL .

The Previous Setup button disappears when the previous settings are confirmed and reappears when ventilating with new settings.

4.5.6 Constant Timing Variable During Rate Changes

A breath timing graph appears at the bottom of the setup screen which illustrates the relationship between inspiratory time, expiratory time, I:E ratio, respiratory rate, and the effects on breath timing due to flow pattern, tidal volume, and ⩒

MAX

during mandatory PC, VC, BiLevel, or VC+ breaths. With BiLevel, PC and VC+ breaths, three padlock icons are located underneath the breath timing graph allowing the operator to select, from left to right, T

I:E ratio, or T

as the constant variable during rate changes (or T

, T

ratio, or T

in BiLevel). If the ventilation mode is SPONT, the padlock icons do not appear, and the breath timing graph only displays T

for a manual inspiration.

If the mandatory type is VC, the icons do not appear, but the breath timing graph displays T

, I:E ratio, and T

To choose a constant timing variable for rate changes

1. Touch a padlock icon corresponding to the parameter to make constant during rate changes (this changes the padlock’s appearance from unlocked to locked). The locked parameter glows in the settings area.

2. Turn the knob to adjust the parameter’s value.

3. Touch Accept .

4.6 Predicted Body Weight (PBW) Calculation

Many default ventilator and alarm settings are based on patient PBW. Either through the entry of height and gender or directly via setting PBW, the PBW range spans at least 3.5 kg (7.7 lb) through at least the 155 kg (342 lb) male and the 150 kg (331 lb) female. Understanding how the ventilator operates at the very low end of the range of PBW requires awareness that an entry or prediction for PBW drives the value of a delivered volume, which has a lower limit of 2.0 mL (if using the NeoMode 2.0 option). Data for adult male and female PBW as a function of height were calculated by applying the equations presented on www.ards.net.

Assume the ventilator (via direct height or PBW entry) registered a PBW of 0.3 kg. If a delivered volume of 4 mL/kg

(PBW) was specified, the required volume would equal only 1.2 mL, which is less than the ventilator minimum of

2.0 mL. At a desired 4 mL/kg, the infants’ PBW would need to be at least 0.5 kg or the desired volume must be reset to greater than 4 mL/kg (PBW). Once the PBW of the premature infant approaches 1.0 kg (2.2 lb), this restriction disappears.

After entering PBW, review and change all settings as needed.

The correlation function PBW = height was derived from the sources referenced. For subjects whose body weight/height data define the range of PBWs that include the 20- to 23-week gestational-age neonates and the young male and female adolescent adults at the foot of the ARDS tables, their PBW values were taken as the 50th percentile numbers in the Fenton tables and the CDC and NCHS charts and tables, respectively. Note that the

106

Fenton tables provided the exclusive information for premature and infant data between 20 weeks and 50 weeks

of fetal and gestational growth.

123

Note: Any repeated values noted in the tables are the result of decimal rounding.

4.7 Non-invasive Ventilation (NIV)

Warning: Use only non-vented patient interfaces with NIV. Leaks associated with vented interfaces could result in the ventilator’s inability to compensate for those leaks, even if Leak Sync is employed.

Warning: Full-face masks used for non-invasive ventilation should provide visibility of the patient’s nose and mouth to reduce the risk of emesis aspiration.

Warning: When using NIV, the patient’s exhaled tidal volume (V patient data V

) could differ from the ventilator’s monitored

reading due to leaks around the mask. To avoid this, ensure Leak Sync is installed. When NIV is selected, Leak Sync is automatically enabled. See

Figure 100, page 278

Non-invasive ventilation (NIV) is used when the clinician determines a mask or other non-invasive patient interface rather than an endotracheal tube would result in the desired patient outcome.

4.7.1 NIV Intended Use

NIV is intended for use by neonatal, pediatric, and adult patients possessing adequate neural-ventilatory coupling and stable, sustainable, respiratory drive.

4.7.2 NIV Breathing Interfaces

The following non-vented interfaces are compatible with the use of NIV/CPAP on the Puritan Bennett 980 ventilator:

Full-face mask – ResMed Mirage™* non-vented full face mask

Nasal mask – ResMed Ultra Mirage™* non-vented mask

Infant nasal prongs – Argyle nasal prongs, Hudson RCI™* Infant Nasal prongs, Fisher & Paykel nasal prongs,

Medin™* nasal prongs, and Ram cannula

Uncuffed neonatal ET tube – Shiley Uncuffed tracheal tube, Murphy (3.0 mm)

4.7.3 NIV Setup

NIV can be initiated from either the new patient setup screen during v start-up or while the patient is being

ventilated invasively. See Table 28

for NIV patient setup information.

Table 28.

Setting Up a Patient for NIV

To set up a new patient

1. Turn the ventilator on.

2. Select New Patient.

3. Enter patient’s PBW or gender and height.

4. Touch NIV ventilation type.

To set up a patient currently being ventilated

1. Touch or swipe the menu tab on the left side of the

GUI.

2. Touch Vent Setup.

1 Fenton TR, BMC Pediatrics 2003, 3:13. http://www.biomedcentral.com/1471-2431/3/13.

Hamill, PV V. 1977 NCHS growth curves for children birth to 18 years for the United States: National Center for Health Stat

(Vital and Health Statistics: Series 11, Data from the National Health Survey; no. 165) (DHEW publication; (PHS) 78 - 1650).

1977

Kuczmarski RJ, Ogden CL, Guo SS, et al. 2000 CDC growth charts for the United States: Methods and development.

National Center for Health Statistics. Vital Health Stat 11(246). 2002.

107

Table 28.

Setting Up a Patient for NIV (continued)

To set up a new patient

5. Select mode.

6. Select mandatory type.

7. Complete ventilator settings, including apnea and alarm settings.

To set up a patient currently being ventilated

3. Perform steps 4 through 7 as if setting the ventilator up for a new patient.

4. Review the settings, including apnea and alarm set‐ tings and change if necessary.

To function as intended, D patient.

SENS

needs to be set between the LEAK data value displayed while the patient is connected, and the LEAK data value displayed when the interface is open to ambient and not connected to the

To set D

SENS

with NIV interfaces when Leak Sync is enabled

1. After adjusting the patient settings, start ventilation.

2. Ensure that Leak Sync is enabled and set D

SENS

to the highest setting.

3. Select LEAK (L/min) to be displayed in the patient data banner.

4. With the NIV interface connected to the breathing circuit and open to ambient, use the patient data value called LEAK to quantify the leak in L/min.

5. Set the D

SENS

(in L/min) below the leak rate (in L/min) to ensure that the disconnect alarm is violated during a disconnect. Note that this will cause a CIRCUIT DISCONNECT alarm.

6. Connect the patient interface to the patient and ensure that the CIRCUIT DISCONNECT alarm is resolved.

7. D

SENS

needs to be set higher than the LEAK data value displayed while the patient is connected and lower than the LEAK data value displayed when the interface is open to ambient and not connected to the patient.

8. Periodically assess the leak rate, especially with PEEP changes, and adjust the D is connected to the patient.

SENS

setting as needed to ensure the presence of an alarm during disconnect and the absence of nuisance alarms while the interface

9. Always use alternative methods of monitoring during NIV.

4.7.4 Conversion from Invasive to NIV Ventilation Type

Note: Before switching to non-invasive ventilation from invasive ventilation when the EtCO

2 ensure the EtCO

option is disabled.

sensor was used,

Warning: For proper ventilation when changing the ventilation type on the same patient, review the automatic settings changes described. Adjust appropriately based on the relevant tables.

Some ventilator settings available during Invasive ventilation are not available during NIV. See Table 29

for automatic settings changes when changing ventilation type from Invasive to NIV.

Table 29.

Invasive to NIV on Same Patient

Current Invasive setting

Breath mode: BiLevel

Breath Mode: SIMV or SPONT

Mandatory type: VC+

Spontaneous type: Any type except PS

Trigger type: Pressure (P-Trig)

New NIV setting

Breath mode: A/C

High T

I SPONT

( ⤒ T

I SPONT

) limit setting available

Mandatory type:

Neonatal: PC

Adult/Pediatric: VC

Spontaneous type: PS

Trigger type: Flow ( ⩒ -Trig)

(Flow-triggering is the only allowable trigger type dur‐ ing NIV)

108

Table 29.

Invasive to NIV on Same Patient (continued)

Current Invasive setting

Alarm settings: ⤓ P

⤓ V

TE SPONT

PEAK

(if applicable), ⤓⩒

E TOT

, ⤓ V

TE MAND

INSPIRATION TOO LONG (not user-settable)

SENS

New NIV setting

Alarm settings: ⤓ P

PEAK

, ⤓⩒

E TOT

⤓ V

TE MAND

, ⤓ V

TE SPONT default to NIV new patient values. See

Table 65 . INSPI‐

RATION TOO LONG alarm not available.

SENS

setting defaults to OFF if Leak Sync is disabled.

Note: In any delivered spontaneous breath, either Invasive or NIV, if pressure support is set to 0 cmH

2 always a target inspiratory pressure of 1.5 cmH

O applied.

O, there is

When in NIV, the vent setup button’s appearance changes, letting the operator know the ventilation type is NIV.

Figure 41.

Vent Setup Button “NIV” Indicating NIV Ventilation Type

4.7.5 Conversion from NIV to Invasive Ventilation Type

Table 30 shows automatic settings changes made when changing ventilation type from NIV to Invasive.

Table 30.

NIV to Invasive on Same Patient

Current NIV setting

Ventilator settings: ⤒ T

I SPONT

Alarm settings:

⤓ P

PEAK

, ⤓⩒

E TOT

, ⤓ V

TE MAND

, ⤓ V

TE SPONT

SENS

N/A

New Invasive setting

Alarm settings: Default to new patient values depend‐ ent upon selected Invasive ventilator settings.

INSPIRATION TOO LONG alarm becomes available.

SENS

setting defaults to OFF if Leak Sync is enabled.

4.7.6 High Spontaneous Inspiratory Time Limit Setting

NIV includes a setting in SIMV or SPONT modes for high spontaneous inspiratory time limit ( ⤒ T

I SPONT

). When a patient’s inspiratory time reaches or exceeds the set limit, the ventilator transitions from inspiration to exhalation, and the ↑ T

I SPONT

symbol appears at the lower left on the GUI screen, indicating the ventilator has truncated the breath (

Figure 42

). The ⤒ T

I SPONT

setting does not restrict changes to PBW; if the PBW is decreased, ⤒ T decrease automatically to remain within its allowable limits.

I SPONT

may

109

Figure 42.

⤒ T

I SPONT

Indicator

Warning: No audible alarm sounds in conjunction with the visual ⤒ T

I SPONT appear in any alarm log or alarm message.

indicator, nor does the indicator

It is possible the target inspiratory pressure may not be reached if the ⤒ T system leaks are so large as to cause the ventilator to truncate the breath at the maximum allowable ⤒ T setting.

I SPONT

setting is not long enough, or if

I SPONT

Note: To reduce the potential for not reaching the target pressure, minimize the leaks in the system and increase the rise time% and/or decrease the E

SENS

setting, if appropriate.

4.7.7 NIV Apnea Setup

Set the patient’s apnea parameters as described. See

Section 4.5.2, Apnea Settings, page 102

. NIV does not change the way apnea parameters are set.

4.7.8 NIV Alarm Settings

The system initially sets most alarm settings based on the patient’s PBW. Review all alarm settings, and change as necessary, but startup does not require confirmation of the settings. Alarm settings are made in exactly the same way in NIV as for Invasive ventilation.

110

Figure 43.

Default NIV Alarm Settings

Touch the Alarms tab at any time during ventilation to show the current limits and the monitored patient value shown in white on the indicating arrows for each alarm

Figure 43 . If an alarm is occurring, the indicator LED color

changes based on alarm priority. See Table 34, page 144

for colors and meanings of alarms and their priorities.

Note: The upper and lower limits of an alarm cannot conflict with each other.

Note: The upper limits for the spontaneous exhaled tidal volume and mandatory exhaled tidal volume alarms are always the same value. Changing the upper limit of one alarm automatically changes the upper limit of the other.

4.8 Manual Inspiration

A manual inspiration is an operator-initiated mandatory (OIM) inspiration. When the operator presses the manual inspiration key while the ventilator is in a mode that includes mandatory breaths (includ‐ ing mixed modes BiLevel and SIMV), the ventilator delivers the manual inspiration using the currently set mandatory breath parameters. A manual inspiration performed while the ventilator is in the SPONT mode uses the currently set apnea breath parameters. A volume-based manual inspiration is com‐ pliance-compensated. Pressing the manual inspiration key while in BiLevel mode will transition from

to T

or T

to T

depending on when in the breath cycle the key was pressed.

4.9 Respiratory Mechanics Maneuvers

To access respiratory mechanics maneuvers

1. Touch or swipe the Menu tab on the left side if the GUI.

2. Touch RM.

111

Figure 44.

RM in Menu Tab

3. Touch the particular tab for the desired maneuver.

Figure 45.

Respiratory Maneuver Tabs

4. Follow the prompts on the GUI screen.

5. Accept or reject the maneuver results. If the result is accepted, its value is saved.

4.9.1 Inspiratory Pause Maneuver

An inspiratory pause maneuver closes the inspiration and exhalation valves and extends the inspiratory phase of a single, mandatory breath for the purpose of measuring end inspiratory circuit pressure to calculate inspiratory plateau pressure (P

), lung static compliance (C

STAT

), and static resistance (R

STAT

) of the respiratory system.

Pressures on either side of the artificial airway are allowed to equilibrate, which determines the pressure during a

112

4 no-flow state. A request for an inspiratory pause is ignored during apnea ventilation, safety PCV, OSC, BUV, and in

Stand-By state. Inspiratory pauses are allowed in A/C, SIMV, BiLevel and SPONT modes. If an inspiratory pause maneuver has already occurred during the breath, a second inspiratory pause maneuver is not allowed.

Inspiratory pauses can be classified as automatic or manual . The automatic inspiratory pause lasts at least 0.5

second but no longer than three seconds. A manual inspiratory pause starts by pressing and holding inspiratory pause key. The pause lasts for the duration of the key-press (up to 7 seconds).

To perform an automatic inspiratory pause

1. Press and release the inspiratory pause key on the GUI bezel or touch and release Start if performing an

inspiratory pause from the GUI screen as shown in Figure 45 . The ventilator performs the inspiratory pause

maneuver and displays P

, C

STAT

, and R

STAT

along with the date and time.

2. Touch the Accept or Reject button to save or dismiss results. If the Accept is touched, the results are displayed.

Cancel an automatic inspiratory pause maneuver by touching Cancel on the GUI screen.

To perform a manual inspiratory pause

1. Press and hold the inspiratory pause key on the GUI bezel or touch and hold Start on the GUI screen if performing an inspiratory pause from the GUI screen as shown above. The ventilator prompts that the maneuver has started, and to release to end the maneuver. The ventilator performs the inspiratory pause maneuver and displays P

, C

STAT

, and R

STAT

, along with the date and time.

2. Touch Accept or Reject to save or dismiss results. If Accept is touched, the results are displayed.

Cancel a manual inspiratory pause maneuver by releasing the inspiratory pause key.

4.9.2 Expiratory Pause Maneuver

An expiratory pause extends the expiratory phase of the current breath for the purpose of measuring end expiratory lung pressure (PEEP

) or total PEEP. It has no effect on the inspiratory phase of a breath, and only one expiratory pause per breath is allowed. For I:E ratio calculation purposes, the expiratory pause maneuver is considered part of the expiratory phase.

During an expiratory pause, both inspiratory and exhalation valves are closed, allowing the pressures on both sides of the artificial airway to equilibrate. This allows intrinsic PEEP (PEEP

) to be calculated. PEEP

is PEEP

minus the set PEEP level. An expiratory pause can be either automatically or manually administered, and is executed at the next mandatory breath in A/C, SIMV, or BiLevel modes. In SIMV, the breath cycle in which the pause becomes active (when the next scheduled ventilator initiated mandatory (VIM) breath occurs) will be extended by the amount of time the pause is active. For A/C and SIMV, the expiratory pause maneuver is scheduled for the next end-of-exhalation prior to a mandatory breath. In BiLevel the expiratory pause maneuver is scheduled for the next end-of-exhalation prior to a transition from P

to P

. During the expiratory pause maneuver, PEEP

and PEEP

L equilibration time values are displayed and regularly updated because stabilization of one of these values can indicate the pause can be ended. During the expiratory pause, the Apnea Interval T

is extended by the amount of time the pause is active. Expiratory pause maneuver requests are ignored if the ventilator is in apnea ventilation, safety PCV, OSC, BUV, and Stand-By state. Additionally, SEVERE OCCLUSION alarms are suspended during expiratory pause maneuvers. If flow triggering is active, backup pressure sensitivity (P

SENS

) detects patient breathing effort.

Maximum duration for a manual expiratory pause is 15 seconds and 3 seconds for an automatic expiratory pause.

During a manual or automatic expiratory pause, PEEP

and PEEP

appear on the GUI with the next VIM to allow the clinician to view when these values are stabilized, indicating the maneuver can be ended.

To perform an automatic expiratory pause

113

Press and release the expiratory pause key on the GUI or touch and release Start if performing the expiratory pause from the GUI screen. The ventilator performs the expiratory pause maneuver and displays a circuit pressure graph,

PEEP

, and PEEP

, along with the date and time.

To perform a manual expiratory pause

1. Press and hold the expiratory pause key on the GUI bezel or touch and hold the Start if performing the expiratory pause from the GUI screen. The ventilator prompts that the maneuver has started, and to release the button to end the maneuver. The ventilator performs the expiratory pause maneuver and displays a circuit pressure graph, PEEP

, and PEEP

, along with the date and time.

2. Accept or reject the pause results.

To cancel an expiratory pause maneuver

• Touch Cancel on the GUI screen.

4.9.3 Other Respiratory Maneuvers

To perform other respiratory maneuvers, touch the corresponding tab on the desired maneuver, and follow the prompts on the GUI screen.

4.10 Oxygen Sensor Function

The ventilator’s oxygen sensor monitors O

%. This cell is mounted in the mix module in the BDU and monitors the percentage of oxygen in the mixed gas delivered to the breathing circuit (it may not reflect the actual oxygen concentration in the gas the patient inspires).

See the Puritan Bennett 980 Series Ventilator Service Manual for instructions on replacing the O

sensor.

New patient default O

% settings are as follows:

• O

sensor enabled

• Neonatal: 40% O

• Pediatric/adult: 100% O

Note: The oxygen sensor can possess three states: enabled, disabled, and calibrate. The oxygen sensor is enabled at ventilator startup regardless if New Patient or Same Patient setup is selected.

To enable, or disable the O

sensor

1. Touch the vent setup button.

2. Touch the More Settings tab. The more settings screen appears.

114

Figure 46.

More Settings Screen with O

Sensor Enabled

3. Touch the button corresponding to the desired O

sensor function (Enabled or Disabled).

4. Touch Accept .

4.10.1 Oxygen Sensor Life

The O

% setting can range from room air (21% O

) up to a maximum of 100% oxygen. The sensor reacts with oxygen to produce a voltage proportional to the partial pressure of the mixed gas. Since ambient atmosphere contains approximately 21% oxygen, the sensor constantly reacts with oxygen and always produces a voltage.

The useful life of the cell can also be shortened by exposure to elevated temperatures and pressures. During normal use in the ICU, the oxygen sensor lasts for approximately one year — the interval for routine preventive maintenance.

Because the oxygen sensor constantly reacts with oxygen, it requires periodic calibration to prevent inaccurate

% alarm annunciation. Once a calibrated oxygen sensor and the ventilator reach a steady-state operating temperature, the monitored O

% will be within three percentage points of the actual value for at least 24 hours.

To ensure the oxygen sensor remains calibrated, recalibrate the oxygen sensor at least once every 24 hours.

Typically, the clinician uses an O

analyzer in conjunction with the information given by the ventilator. If a NO O

SUPPLY alarm occurs, compare the O

analyzer reading with the ventilator’s O

reading for troubleshooting purposes. The ventilator automatically switches to 100% air delivery.

4.10.2 Oxygen Sensor Calibration

The oxygen sensor should be calibrated every 24 hours and before use. The calibration function provides a single-point O

sensor calibration.

To calibrate the O

sensor

1. Touch the vent setup button.

2. Touch the More Settings tab.

115

3. Touch Calibrate for the O

sensor. The calibration procedure results in 100% O

being delivered through the breathing circuit for the 2-minute calibration period. See

Figure 46, page 115 .

4.10.3 Oxygen Sensor Calibration Testing

To test the O

sensor calibration

1. Connect the ventilator’s oxygen hose to a known 100% O

2 cylinder).

source (for example, a medical-grade oxygen

2. Calibrate the oxygen sensor as described.

3. Connect the ventilator oxygen hose to another known 100% O

2 medical-grade oxygen cylinder).

source (for example, a second

4. Set O

% to each of the following values, and allow 1 minute after each for the monitored value to stabilize:

21%, 40%, 90%

5. Watch the GUI screen to ensure the value for O

2 minute of selecting each setting.

(delivered O

%) is within 3% of each setting within one

4.11 Ventilator Protection Strategies

The ventilator incorporates a number of strategies to support patient safety. These include power on self-test

(POST), SST and a strategy called Ventilation Assurance which provides alternate means of ventilation in the case of certain serious faults in the breath delivery system. The next descriptions detail the system response to potential failures.

4.11.1 Power on Self Test (POST)

The first strategy is to detect potential problems before the ventilator is placed on a patient. POST checks the integrity of the ventilator’s electronics and prevents ventilation if a critical fault is found. See the Puritan Bennett

980 Series Ventilator Service Manual for a complete description of POST. POST may detect major or minor

system faults which manifest themselves as Device Alerts. See Section 6.5.13, DEVICE ALERT Alarm, page 159 for

more information.

4.11.2 Technical Fault

A technical fault occurs if a POST or background test has failed. See Section 10.17, Power On Self Test (POST), page 241 . Based on the test that failed, the ventilator will either ventilate with current settings, ventilate with

modified settings, or enter the vent inop state. A technical fault cannot be cleared by pressing the alarm reset key.

It can only be cleared by correcting the fault that caused it or if alarm reset criteria have been met.

4.11.3 SST

In addition to characterizing the ventilator breathing circuit, SST performs basic checks on the ventilator’s pneumatic system including the breath delivery PSOL, the flow sensors and the exhalation valve. Faults detected during SST must be corrected before ventilation can be started.

4.11.4 Procedure Error

A procedure error occurs when the ventilator senses a patient connection before ventilator setup is complete. The ventilator provides ventilatory support using default safety pressure controlled ventilation (Safety PCV) settings.

See

Table 54, page 239 .

116

4.11.5 Ventilation Assurance

During ventilation, the ventilator performs frequent background checks of its breath delivery subsystem (See

Section 10.16, Safety Net, page 238 ). In the event that certain critical components in the pneumatics fail, Ventilation

Assurance provides for continued ventilatory support using one of three backup ventilation (BUV) strategies, bypassing the fault to maintain the highest degree of ventilation that can be safely delivered (see

Section 10.16.4,

Background Diagnostic System, page 240

for a full description of the backup ventilation strategies).

Note: Do not confuse BUV with Safety PCV, which occurs when a patient is connected before ventilator setup is complete, or with apnea ventilation, which occurs in response to patient apnea.

4.11.6 Safety Valve Open (SVO)

In the event of a serious fault occurring that cannot be safely bypassed, the ventilator, as a last resort, reverts to a safe state. In Safe State, the ventilator opens the safety valve and the exhalation valve, allowing the patient to breathe room air (if able to do so), provided the patient circuit is not occluded. During SVO, the patient (if connected) can breathe room air through the safety valve after it releases pressure in the patient circuit. The patient exhales through the exhalation valve with minimal resistance and the exhalation valve also acts like a check valve, limiting gas from being drawn in through the exhalation filter or expiratory limb of the circuit. SVO conditions are logged into the event and alarm logs as are the events leading to the SVO condition. If the condition causing SVO clears, the ventilator clears the SVO state. Patient data do not display on the GUI, but graphics are still plotted. During SVO, the ventilator ignores circuit occlusions and disconnects. If the condition causing SVO can only be corrected by servicing the ventilator, the SVO alarm cannot be reset by pressing the alarm reset key.

4.11.7 Ventilator Inoperative (Vent Inop)

Vent Inop occurs when the ventilator detects a catastrophic error which prevents all other safety states from operating. Vent Inop limits pressure to the patient as the ventilator enters the SVO state, disables (closes) the inspiratory valves (PSOLs), and purges the gas mixing system accumulator. The safety valve is opened, a vent inop indicator illuminates, a high priority alarm annunciates from the primary alarm, and the secondary alarm

(continuous tone) is activated. The ventilator can only exit the vent inop state by power cycling and successfully passing EST. The vent inop alarm cannot be reset with the alarm reset key. All detection and annunciation of patient data alarm conditions is suspended.

4.12 Ventilator Shutdown

When the ventilator power switch is turned off, the ventilator executes an orderly shutdown routine, saving patient data before removing power. If the ventilator detects a patient connected when the power switch is turned off, a high priority alarm is annunciated and a banner on the display requires the operator to confirm that a power down was requested. Only after the operator confirms will the ventilator execute the shutdown command.

All logs are retained in the ventilator’s memory upon ventilator shutdown. When the logs reach the maximum

number of entries, the oldest values are overwritten with new values. See Section 8.5, Ventilator Logs, page 187 for

information on ventilator logs.

117

118

5 Product Data Output

5.1 Overview

This chapter describes the features of the Puritan Bennett 980 Series Ventilator designed to provide output to the clinician. This includes language, methods of displaying and transferring data, types of displayed data, and types of external device ports. Connectivity to an external patient monitoring system is also included.

5.2 Language

The language used on the ventilator is configured at the factory.

5.3 Data Display

Displayed data are updated in real-time. The practitioner can display up to 60 seconds of waveform data and pause and capture up to two loops using the screen capture function. The operator can pause the displays and when the displays are paused, a cursor appears with the relevant numeric values for the intersecting points of the cursor and waveform or loop. The scalar waveform contains a single value, but loops contain both x- and y-axis data. The operator can move the cursor along the waveform or loop using the knob, and read the corresponding

data. See Section 3.8.2.9, Waveforms, page 83 for details regarding configuring and displaying waveforms.

5.4 Data Transfer

Data from the ventilator can be accessed via USB or RS-232 connectors. The following data are available for downloading via connection to a remote device or flash drive:

• Waveform images (screen capture function): USB port

• Waveform data: RS-232 port, USB port with USB to serial conversion capability (per Comm port configuration)

• Results from DCI commands: RS-232 port, USB port with USB to serial conversion capability (per Comm port configuration)

5.4.1 GUI Screen Capture

Caution: The USB interface should be used for saving screen captures and interfacing with an external patient monitor. It should not provide power to other types of devices containing a USB interface.

Caution: Only compatible USB devices should be used, otherwise GUI performance may be impacted.

A 128 MB flash drive storage device formatted in the 32-bit file format is required for downloading images from the USB ports. The USB device listed in

Table 45

is the ONLY compatible USB device currently available for use on the PB980. To order a compatible USB device, contact Medtronic Technical Services at 800 255 6774 or contact a local Medtronic representative.

To capture GUI screens

1. Navigate to the desired screen from which you wish to capture an image (for example, the waveforms screen). There is no need to pause the waveform before performing the screen capture.

2. Touch the screen capture icon in the constant access icons area of the GUI screen.

If desired, navigate to another screen and repeat steps 1 and 2 for up to ten images. If another image is captured, increasing the queue to eleven images, the newest image overwrites the oldest image so there are always only ten images available.

119

Note: If the camera icon appears dim, it means that the screen capture function is currently processing images, and is unavailable. When processing is finished, the camera icon is no longer dim and the screen capture function is available.

To transfer captured images to a USB storage device

1. Swipe the Menu on the left side of the GUI.

See

Figure 36, page 100 .

2. Touch Screen Capture. A list of screen captures appears, identified by time and date. A slider also appears indicating more images than shown are present.

3. Insert a passive USB storage device (flash drive) into one of the USB ports at the rear of the ventilator. The proper orientation of the USB device is with metal contacts facing the test button. See

Section 5.5.1, Port Use, page 131 . If more than one USB storage device is installed in the ventilator, touch the button of the

destination USB device where the image will be copied. If an incompatible device is inserted, the port will be disabled until the device is removed and removal is confirmed by touching the confirm button. The

message shown in Figure 47 appears.

Figure 47.

Incompatible USB Device Message

Note: Removal of the external USB storage device while screenshot files are being written to it may result in incomplete file transfer and unusable files.

4. In the list of images, touch the image name.

5. Touch Copy. The image is stored on the destination USB storage device.

6. Alternatively, touch Select All, and all images in the list are stored on the USB device and which can then be viewed and printed from a personal computer.

Note: The file format of screen captures is .PNG.

5.4.2 Communication Setup

To specify the communication configuration for the ventilator

1. Touch the configure icon in the constant access icons area of the GUI.

120

A menu appears with several tabs.

2. Touch the Comm Setup tab. The Comm Setup screen appears allowing three ports to be configured. These ports can be designated as DCI, DCI 2.0, DCI 3.0, Philips, Spacelabs, or Waveforms.

Figure 48.

Comm Setup Screen

Note: Waveforms can be selected on any port, but only on one port at a time.

5.4.3 Comm Port Configuration

Configuring the Comm port allows the ventilator to communicate with devices listed in the Comm Setup screen, or to capture waveform data (in ASCII format) from the ventilator.

To configure Comm ports

1. Touch COM1, COM2, or COM3.

2. Turn the knob indicating the desired device configuration.

3. Select the desired baud rate. If waveforms was selected, the baud rate automatically becomes configured to 38400.

4. Select 7 or 8 data bits.

5. Select parity of even, odd, or none if data bits = 8.

Connect the device to the previously configured port. See

Figure 49, page 131 for a description and the locations

of the Comm ports.

Note: When a USB port is configured as a Comm port, it is necessary to use a USB-to-serial adapter cable. This adapter must be based on the chipset manufactured by Prolific. For further information, contact your Medtronic representative.

Selecting waveforms when configuring a Comm port allows the ventilator to continuously transmit pressure, flow, and sequence numbers in ASCII format from the selected serial port, at a baud rate of 38400 bits/s, and the operator- selected stop bits, and parity. A sample of pressure and flow readings is taken every 20 ms. This sample of readings is transmitted on the selected serial port at the end of each breath at breath rates of 10/min and higher.

121

For longer duration breaths, at least the first 8 seconds of the breath is transmitted. The format of the data is as follows: The beginning of inspiration is indicated by “BS, S:nnn,<LF>“ where ’BS’ identifies the Breath Start, ‘S:nnn’ is a sequence number incremented at every breath, and <LF> is a line feed character. The fff, and ppp fields show the breath flow and pressure data. The end of exhalation is indicated by: “BE<LF>“ where ‘BE’ indicates Breath End, and <LF> is a line feed character.

5.4.4 Serial Commands

The ventilator system offers commands that allow communication to and from the ventilator using a Comm port.

Commands to the ventilator from a remote device include:

• RSET: See Section 5.4.5, RSET Command, page 122

• SNDA: See

Section 5.4.6, SNDA Command, page 122

• SNDF:

Section 5.4.7, SNDF Command, page 125 .

Note: The ventilator responds only if it receives a carriage return <CR> after the command string.

5.4.5 RSET Command

The RSET command clears data from the ventilator receive buffer. The ventilator does not send a response to the host system. Enter the RSET command exactly as shown:

RSET<CR>

5.4.6 SNDA Command

The SNDA command instructs the ventilator to send information on ventilator settings and monitored patient data to the host system. Enter the SNDA command exactly as shown:

SNDA<CR>

When the ventilator receives the command SNDA<CR>, it responds with the code MISCA, followed by ventilator settings and monitored patient data information.

The MISCA response follows this format:

MISCA

706

<STX>

FIELD 5, … FIELD 101,

<ETX>

<CR>

1 Response code to SNDA command

2 Number of bytes between <STX> and <CR>

3 Number of data fields between <STX> and

<ETX>

4 Start of transmission (02 hex)

5 Data field, left-justified and padded with spaces

6 End of transmission (03 hex)

7 Terminating carriage return

Fields not available are marked as “Not used.” Underscores represent one or more spaces that pad each character string.

Table 31 lists MISCA responses to SNDA commands.

Table 31.

MISCA Response

Component

MISCA

706

<STX>

Field 5

Description

Response to SNDA command (5 characters)

The number of bytes between <STX> and <CR> (3 characters)

The number of fields between <STX> and <ETX> (2 characters)

Start of transmission character (02 hex)

Ventilator time (HH:MM_) (6 characters)

122

Field 27

Field 28-29

Field 30

Field 31-33

Field 34

Field 35

Field 36

Field 37

Field 38

Field 39

Field 40

Field 41

Field 7

Field 8

Field 9

Field 10

Field 11

Field 12

Field 13

Field 14

Field 15

Field 16

Field 17-20

Field 21

Field 22

Field 23

Field 24

Field 25

Field 26

Table 31.

MISCA Response (continued)

Component

Field 6

Field 42

Field 43-44

Field 45

Field 46

Field 47

Field 48

Field 49-50

Field 51

Ventilator ID to allow external hosts to uniquely identify each Puritan Bennett 980 Series

Ventilator (18 characters)

Description

Room number (6 characters)

Date (MMM_DD_YYYY_) (12 characters)

Mode (CMV___, SIMV__, CPAP__ or BILEVL) (CMV = A/C) setting (6 characters)

Respiratory rate setting in breaths per minute (6 characters)

Tidal volume setting in liters (6 characters)

Peak flow setting in liters per minute (6 characters)

% setting (6 characters)

Pressure sensitivity setting in cmH

O (6 characters)

PEEP or P

(in BiLevel) setting in cmH

O (6 characters)

Plateau time in seconds (6 characters)

Not used (6 characters)

Apnea interval in seconds (6 characters)

Apnea tidal volume setting in liters (6 characters)

Apnea respiratory rate setting in breaths per minute (6 characters)

Apnea peak flow setting in liters per minute (6 characters)

Apnea O

% setting (6 characters)

Pressure support setting in cmH

O (6 characters)

Flow pattern setting (SQUARE or RAMP__) (6 characters)

Not used (6 characters)

Elevate O

state (ON____ or OFF___) (6 characters)

Not used (6 characters)

Total respiratory rate in breaths per minute (6 characters)

Exhaled tidal volume in liters (6 characters)

Exhaled minute volume in liters (6 characters)

Spontaneous minute volume in liters (6 characters)

Maximum circuit pressure in cmH

O (6 characters)

Mean airway pressure in cmH

O (6 characters)

End inspiratory pressure in cmH

O (6 characters)

Expiratory component of monitored value of I:E ratio, assuming inspiratory component of 1 (6 characters)

High circuit pressure limit in cmH

O (6 characters)

Not used (6 characters)

Low exhaled tidal volume limit in liters (6 characters)

Low exhaled minute volume limit in liters (6 characters)

High respiratory rate limit in breaths per minute (6 characters)

High circuit pressure alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Not used (6 characters)

Low exhaled tidal volume (mandatory or spontaneous) alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

123

Field 71

Field 72-83

Field 84

Field 85

Field 86

Field 87

Field 88

Field 89

Field 90

Field 91

Field 92

Field 93

Field 94

Field 95

Field 96

Table 31.

MISCA Response (continued)

Component

Field 52

Field 53

Field 54

Field 55

Field 56

Field 57

Field 58-59

Field 60

Field 61

Field 62

Field 63

Field 64

Field 65

Field 66

Field 67

Field 68

Field 69

Field 70

Field 97

Field 98

Field 99

Field 100

Field 101

Description

Low exhaled minute volume alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

High respiratory rate alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

No O

supply alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

No air supply alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Not used (6 characters)

Apnea alarm status (NORMAL, ALARM_, or RESET_) (6 characters)

Not used (6 characters)

Ventilator time (HH:MM_) (6 characters)

Not used (6 characters)

Date (MMM_DD_YYYY_) (12 characters)

Static compliance (C

STAT

) from inspiratory pause maneuver in mL/cmH

O (6 characters)

Static resistance (R

STAT

) from inspiratory pause maneuver in cmH

O/L/s (6 characters)

Dynamic compliance (C

DYN

) in mL/cmH

O (6 characters)

Dynamic resistance (R

DYN

) in cmH

O/L/s (6 characters)

Negative inspiratory force (NIF) in cmH

O (6 characters)

Vital capacity (VC) in L (6 characters)

Peak spontaneous flow (PSF) in L/min (6 characters)

Ventilator-set base flow in liters per minute

(6 characters)

Flow sensitivity setting in L/min (6 characters)

Not used (6 characters)

End inspiratory pressure in cmH

O (6 characters)

Inspiratory pressure or P

setting in cmH

O (6 characters)

Inspiratory time or T

setting in seconds (6 characters)

Apnea interval setting in seconds (6 characters)

Apnea inspiratory pressure setting in cmH

O (6 characters)

Apnea respiratory rate setting in breaths per minute (6 characters)

Apnea inspiratory time setting in seconds (6 characters)

Apnea O

% setting (6 characters)

Apnea high circuit pressure limit in cmH

O (6 characters)

Audio paused state (ON____ or OFF___) (6 characters)

Apnea alarm status (NORMAL, ALARM_ or RESET_) (6 characters)

Severe Occlusion/Disconnect alarm status (NORMAL, ALARM_ or RESET_) (6 characters)

Inspiratory component of I:E ratio or High component of H:L (BiLevel) setting

(6 characters)

Expiratory component of I:E ratio setting or Low component of H:L (BiLevel)

(6 characters)

Inspiratory component of apnea I:E ratio setting (6 characters)

Expiratory component of apnea I:E ratio setting (6 characters)

Constant during rate setting change for pressure control mandatory breaths (I-TIME or

I/E___ or______) (6 characters) (where ______ represents T

or PCV not active)

Monitored value of I:E ratio (6 characters)

124

Table 31.

MISCA Response (continued)

Component

<ETX>

<CR>

Description

End of transmission character (03 hex)

Terminating carriage return

5.4.7 SNDF Command

SNDF is a command sent from an external host device to the ventilator system instructing it to transmit all ventilator settings data, monitored patient data, and alarm settings and occurrences. Enter the SNDF command exactly as shown:

SNDF<CR>

When the ventilator receives the command SNDF<CR>, it responds with the code MISCF, followed by ventilator settings, monitored patient data, and alarm information

The MISCF response follows this format:

MISCF

1225*

169

<STX>

FIELD 5, … FIELD

173,

<ETX>

<CR>

1 Response code to SNDF command 5 Data field, left-justified and padded with spaces

6 End of transmission (03 hex) 2 Number of bytes between <STX> and

<CR>

3 Number of data fields between <STX> and

<ETX>

4 Start of transmission (02 hex)

7 Terminating carriage return

* 1229 if Philips is selected for serial port in communication setup

Table 32 lists MISCF responses to SNDF commands

Note: Non-applicable fields will either contain zero or be blank.

Note: Ensure your external devices are compatible with the latest DCI software to prevent incompatibilities as data fields may have been modified.

Table 32.

MISCF Response

Component

MISCF

1225*

169

<STX>

Field 5

Field 6

Field 7

Field 8

Field 9

Field 10

Response to SNDF command (5 characters)

Number of bytes between <STX> and <CR> (4 characters) *1229 if Phillips is selected for the

Comm port in Communication Setup

Description

Number of fields between <STX> and <ETX> (3 characters)

Start of transmission character (02 hex)

Ventilator time (HH:MM_) (6 characters)

Ventilator ID to allow external hosts to uniquely identify each Puritan Bennett 980 Series Ven‐ tilator (18 characters)

Date (MMM_DD_YYYY_) (12 characters)

Ventilation Type (NIV______ or Invasive_ or HFO

T____) (9 characters)

Mode (A/C___, SIMV__, SPONT_ or CPAP__) (6 characters)

Mandatory Type (PC____, VC____, VC+___) (6 characters)

125

Field 36

Field 37

Field 38

Field 39

Field 40

Field 41

Field 42

Field 43

Field 44

Field 45

Field 46

Field 47

Field 48

Field 49

Field 50

Field 51

Component

Field 11

Field 12

Field 13

Field 14

Field 15

Field 24

Field 25

Field 26

Field 27

Field 28

Field 29

Field 30

Field 31

Field 16

Field 17

Field 18

Field 19

Field 20

Field 21

Field 22

Field 23

Field 32

Field 33

Field 34

Field 35

Table 32.

MISCF Response (continued)

Description

Spontaneous Type (PS____, TC____, VS____, PA____) (6 characters)

Trigger Type setting ( ⩒ -Trig, P-Trig, IE

SYNC

) (6 characters)

Respiratory rate setting in breaths/min (6 characters)

Tidal volume (V

Peak flow ( ⩒

MAX

) setting in L (6 characters)

) setting in L/min (6 characters)

% setting (6 characters)

Pressure sensitivity setting in cmH

O (6 characters)

PEEP/CPAP setting in cmH

O (6 characters)

Plateau setting in seconds (6 characters)

Apnea interval setting in seconds (6 characters)

Apnea tidal volume setting in L (6 characters)

Apnea respiratory rate setting in breaths/min (6 characters)

Apnea peak flow setting in L/min (6 characters)

Apnea O

% setting (6 characters)

PCV apnea inspiratory pressure setting in cmH

O (6 characters)

PCV Apnea Inspiratory Time setting in seconds (6 characters)

Apnea flow pattern setting (SQUARE or RAMP) (6 characters)

Apnea mandatory type setting (PC or VC) (6 characters)

Inspiratory component of Apnea I:E ratio (if apnea mandatory type is PC) (6 characters)

Expiratory component of Apnea I:E ratio (if apnea mandatory type is PC) (6 characters)

Support pressure setting (cmH

Flow pattern setting (SQUARE or RAMP) (6 characters)

Elevate O

state (ON or OFF) (6 characters)

High inspiratory pressure alarm setting ( ⤒ P

PEAK

) in cmH

O (6 characters)

Low inspiratory pressure alarm setting ( ⤓ P

PEAK

) in cmH

O or OFF (6 characters)

High exhaled minute volume ( ⤒⩒

Low exhaled minute volume ( ⤓⩒

E TOT

) alarm setting in L/min or OFF (6 characters)

E TOT

) alarm setting in L/min or OFF (6 characters)

High exhaled mandatory tidal volume ( ⤒ V

TE MAND

) alarm setting in mL or OFF (6 characters)

Low exhaled mandatory tidal volume ( ⤓ V

TE MAND

) alarm setting in mL or OFF (6 characters)

High exhaled spontaneous tidal volume ( ⤒ V

TE SPONT

) alarm setting in mL or OFF (6 characters)

Low exhaled spontaneous tidal volume ( ⤓ V

TE SPONT

) alarm setting in mL or OFF (6 characters)

High respiratory rate ( ⤒ f

TOT

) alarm setting in breaths/min or OFF (6 characters)

High inspired tidal volume ( ⤒ V

) alarm setting in mL (6 characters)

Base flow setting in L/min (6 characters)

Flow sensitivity ( ⩒

SENS

) setting in L/min (6 characters)

PCV inspiratory pressure (P

) setting in cmH

O (6 characters)

PCV inspiratory time (T

) setting in seconds (6 characters)

Inspiratory component of I:E ratio setting or High component of H:L ratio setting (6 characters)

Expiratory component of I:E ratio setting or Low component of H:L ratio setting (6 characters)

Constant during rate change setting (I-time, I/E, or E-time) (6 characters)

Tube ID setting in mm (6 characters)

126

Field 79

Field 80

Field 81

Field 82

Field 83

Field 84

Field 85

Field 86

Field 87

Field 88

Field 89

Field 90

Field 64

Field 65

Field 66

Field 67

Field 68

Field 69

Field 70

Field 71

Field 72

Component

Field 52

Field 53

Field 54

Field 55

Field 56

Field 57

Field 58

Field 59

Field 60

Field 61

Field 62

Field 63

Field 73

Field 74

Field 75

Table 32.

MISCF Response (continued)

Field 76

Field 77

Field 78

Description

Tube Type setting (ET or TRACH) (6 characters)

Humidification type setting (Non-heated exp tube, Heated exp tube, or HME) (18 characters)

Humidifier volume setting in L (6 characters)

sensor setting (Enabled or Disabled) (9 characters)

Disconnect sensitivity (D

SENS

) setting in %, L/min or OFF (6 characters)

Rise time% setting (6 characters)

PAV+™ percent support setting (6 characters)

Expiratory sensitivity (E

SENS

) setting in % or L/min for PAV+™ breath type (6 characters)

PBW setting in kg (6 characters)

Target support volume (V

T SUPP

) setting in L (6 characters)

High pressure (P

) setting (in BiLevel) in cmH

O (6 characters)

Low pressure (P

) setting (in BiLevel) in cmH

O (6 characters)

High pressure time (T

) setting (in BiLevel) in seconds (6 characters)

High spontaneous inspiratory time limit ( ⤒ T

I SPONT

) setting in seconds (6 characters)

Circuit type setting (ADULT or PEDIATRIC) (9 characters)

Low pressure time (T

) setting (in BiLevel) in seconds (6 characters)

Expiratory time (T

) setting in seconds (6 characters)

End inspiratory pressure (P

I END

) in cmH

O (6 characters)

Respiratory rate (f

TOT

) in breaths/min (6 characters)

Exhaled tidal volume (V

) in L (6 characters)

Patient exhaled minute volume ( ⩒

E TOT

) in L/min (6 characters)

Peak airway pressure (P

PEAK

) in cmH

O (6 characters)

Mean airway pressure (P

MEAN

) in cmH

O (6 characters)

Expiratory component of monitored value of I:E ratio, assuming inspiratory component of 1 (6 characters)

I:E ratio (6 characters)

Delivered O

% (6 characters)

Monitored inspired tidal volume (V

) in L # (6 characters)

# VTL (L), If Leak Sync ON.

Intrinsic PEEP (PEEP

) in cmH

O (6 characters)

Estimated total resistance (R

TOT

) in cmH

O/L/s (6 characters)

Estimated patient resistance (R

PAV

) in cmH

O/L/s (6 characters)

Estimated patient elastance (E

PAV

) in cmH

O/L (6 characters)

Estimated patient compliance (C

PAV

) in mL/cmH

O (6 characters)

Not used

Rapid shallow breathing index ( f /V

) (6 characters)

Spontaneous percent inspiratory time (T

TOT

) (6 characters)

Monitored Positive end expiratory pressure (PEEP) in cmH

O (6 characters)

Spontaneous inspiratory time (T

I SPONT

) in seconds (6 characters)

Exhaled spontaneous minute volume ( ⩒

E SPONT

) in L/min (6 characters)

Intrinsic PEEP (PEEP

) from expiratory pause maneuver in cmH

O (6 characters)

127

Field 119

Field 120

Field 121

Field 122

Field 123

Field 124

Field 125

Field 126

Field 127

Field 128

Field 129

Field 130

Table 32.

MISCF Response (continued)

Component

Field 91

Field 92

Field 93

Field 94

Field 95

Field 96

Field 97

Field 98

Field 99

Field 100

Field 101

Field 102

Field 103

Field 104

Field 105

Field 106

Field 107

Field 108

Field 109

Field 110

Field 111

Field 112

Field 113

Field 114

Field 115

Field 116

Field 117

Field 118

Total PEEP (PEEP

TOT

) from expiratory pause maneuver in cmH

O (6 characters)

Static compliance (C

STAT

) from inspiratory pause maneuver in mL/cmH

O (6 characters)

Static resistance (R

STAT

) from inspiratory pause maneuver in cmH

O/L/s (6 characters)

Plateau pressure (P

) from inspiratory pause maneuver in cmH

O (6 characters)

High spontaneous inspiratory time (ALERT_ or blank) (6 characters)

Dynamic compliance (C

DYN

) in mL/cmH

Audio paused (ON or OFF) (6 characters)

Apnea ventilation alarm* (6 characters)

Description

O (6 characters)

Dynamic resistance (R

DYN

) in cmH

O/L/s (6 characters)

Peak spontaneous flow (PSF) in L/min (6 characters)

Peak expiratory flow (PEF) in L/min (6 characters)

End expiratory flow (EEF) in L/min (6 characters)

Proximal Flow Sensor state (ON or OFF) (6 characters)

Negative inspiratory force (NIF) in cmH

O (6 characters)

0.1

pressure change in cmH

O (6 characters)

Vital capacity (VC) in L (6 characters)

High exhaled minute volume alarm* ( ↑ ⩒

E TOT

) (6 characters)

High exhaled tidal volume alarm* ( ↑ V

) (6 characters)

High O

% alarm* (6 characters)

High inspiratory pressure alarm* ( ↑ P

PEAK

) (6 characters)

High ventilator pressure alarm* ( ↑ P

VENT

) (6 characters)

High respiratory rate alarm* ( ↑ f

TOT

) (6 characters)

AC power loss alarm* (6 characters)

Inoperative battery alarm* (6 characters)

Low battery alarm* (6 characters)

Inadvertent Power Off alarm* (6 characters)

Low exhaled mandatory tidal volume alarm* ( ↓ V

TE MAND

) (6 characters)

Low exhaled minute volume alarm* ( ↓ ⩒

E TOT

) (6 characters)

Low exhaled spontaneous tidal volume ( ↓ V

TE SPONT

) alarm* (6 characters)

Low O

% alarm* (6 characters)

Low air supply pressure alarm* (6 characters)

Low O

supply pressure alarm* (6 characters)

Compressor inoperative alarm* (6 characters)

Disconnect alarm* (6 characters)

Severe occlusion alarm* (6 characters)

Inspiration too long alarm* (6 characters)

Procedure error alarm* (6 characters)

Compliance limited tidal volume (V

) alarm* (6 characters)

High inspired spontaneous tidal volume* ( ↓ T

I SPONT

) alarm (6 characters)

Reserved

128

Field 137

Field 138

Field 139

Field 140

Field 141

Field 142

Field 143

Field 144

Field 145

Field 146

Field 147

Field 148

Field 149

Field 150

Field 151

Field 152

Field 153

Field 154

Field 155

Field 156

Field 157

Field 158

Field 159

Field 160

Field 161

Field 162

Field 163

Field 164

Table 32.

MISCF Response (continued)

Component

Field 131

Field 132

Field 133

Field 134

Field 135

Field 136

Field 165

Field 166

Field 167

Field 168

Field 169

Field 170

e e e e e e

High compensation limit ( ↑ P

COMP

Description

) alarm* (6 characters)

PAV+™ startup too long alarm* (6 characters)

PAV+™ R and C not assessed alarm* (6 characters)

Volume not delivered (VC+ alarm* (6 characters)

Volume not delivered (VS) alarm* (6 characters)

Low inspiratory pressure ( ↓ P

PEAK

) alarm* (6 characters)

Technical malfunction A5* (6 characters)

Technical malfunction A10* (6 characters)

Technical malfunction A15* (6 characters)

Technical malfunction A20* (6 characters)

Technical malfunction A25* (6 characters)

Technical malfunction A30* (6 characters)

Technical malfunction A35* (6 characters)

Technical malfunction A40* (6 characters)

Technical malfunction A45* (6 characters)

Technical malfunction A50* (6 characters)

Technical malfunction A55* (6 characters)

Technical malfunction A60* (6 characters)

Technical malfunction A65* (6 characters)

Technical malfunction A70* (6 characters)

Technical malfunction A75* (6 characters)

Technical malfunction A80* (6 characters)

High ETCO

Alarm* (6 characters)

Spontaneous tidal volume (V

TE SPONT

) in liters (6 characters)

Total work of breathing (WOB

TOT

) in Joules/L (6 characters)

Leak Sync state (9 characters) (ON, or OFF)

%LEAK (6 characters)

LEAK in L/min (6 characters)

LEAK

in mL(6 characters)

Prox Inop alarm* (ALARM or NORMAL)

ETCO

(mmHg) when COM port is set to DCI 2.0 or DCI 3.0 (6 characters). Otherwise Blank

Inspiratory Compliance ratio (C20/C) (6 characters)

Three times Inspiratory Time Constant (3Tau

) in seconds (6 characters)

Delivered mL/kg Volume (V

# V

I/PBW) # .

/PBW (mL/kg), If Leak Sync ON. (6 characters)

Monitored Driving Pressure (P

DRIVE

) in cmH

O (6 characters)

Monitored Positive End Expiratory Pressure at Patient Interface (PEEP

) in cmH

O (6 characters)

Monitored End Inspiratory Pressure at Patient Interface (P

I END IF

) in cmH

Monitored Constant Flow ( ⩒

CONST

) in L/min (6 characters)

O (6 characters)

IE Sync Trigger Sensitivity (I

SYNC

) setting (6 characters)

IE Sync Cycle Sensitivity (E

SYNC

) setting (6 characters)

129

Table 32.

MISCF Response (continued)

Component

Field 171

Field 172

Field 173

<ETX>

<CR>

Constant flow ( ⩒

CONST

) setting in L/min (6 characters)

Ventilator State f (6 characters)

Nebulizer State

(6 characters)

End of transmission character (03 hex)

Terminating carriage return

Description

* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.

a Fields 146 to 149 are blank for DCI 3.0.

b Nebulizer Inoperative Alarm*, when COM port is set to DCI 3.0.

c e

CO2 Monitor Inoperaive Alarm* when COM port is set to DCI 3.0.

d Low EtCO2 Alarm*, when COM port is set to DCI 3.0.

Fields 162 to 173 are configured for DCI 3.0, otherwise Blank.

f Possible Ventilator State responses are: STNDBY (Stand-By Mode), SAFPCV (Safety PCV), BREATH (Normal Breathing Mode),

DISCON (Circuit Disconnect), OCCLUD (Occlusion), SVOPEN (Safety Valve Open), BUV (Backup Ventilation), MIX-BUV (Mixer

Backup Ventilation), HFO2T, APNEA.

g Possible Nebulizer State responses are: ON, OFF, SUSPND (Suspended).

5.5 Communication Ports

Warning: The ventilator does not confirm the receipt of the signal to distributed remote devices, including those with alarms. Therefore, ensure alarm volume is appropriately set to avoid missed alarms.

Warning: To avoid possible injury, only connect devices that comply with IEC 60601-1 standard to any of the ports at the rear of the ventilator, with the exception of passive memory storage devices (“flash drives”) and serial-to-USB adapter cables. If a serial-to-USB adapter cable is used, it must be connected to an IEC 60601-1-compliant device.

Warning: To avoid possible injury, do not connect a device that is attached to the patient to any of the non-clinical ports listed in

Figure 49 when the ventilator is ventilating a patient.

130

Figure 49.

Port Locations

1 RS-232 Port (COM 1)

2 Ethernet Port (non-clinical use)

3 Nurse call Port (remote alarm port)

4 USB Port (USB 1) (COM 2) (non-clinical use)

VEN_11244_D

5 USB Port (USB 2) (COM 3) (non-clinical use)

6 HDMI Port (non-clinical use)

7 Service Port (non-clinical use)

5.5.1 Port Use

See

Section 5.4, Data Transfer, page 119

for information on data transfer details.

5.5.1.1 RS-232 Port

To use the RS-232 port

1. Obtain a cable with a male DB-9 connector to connect to the RS-232 port on the ventilator.

2. Make the appropriate connection to a monitoring device. A gender changer, null modem cable or socket saver may be required. Consult with the institution’s Information Technology professional as required.

3. Ensure to specify the baud rate, parity, and data bits in the ventilator communication setup to correctly match the parameters of the monitoring device.

4. A monitor designed to use this port is required for obtaining data from the ventilator. Set up the monitoring device to receive ventilator data. These data can include waveform data.

5. Program the remote device to send the appropriate RS-232 commands as described in the next section.

See

Table 31, page 122 and

Table 32

for MISCA and MISCF responses to SNDA and SNDF commands.

131

5.5.1.2 Ethernet Port

The Ethernet port is used by Covidien-trained service technicians for accessing various logs and updating ventilator software.

5.5.1.3 Nurse Call Port

A remote alarm or nurse call interface is available on the ventilator system which can be used to remotely annunciate the alarm status of the ventilator. Medium and high priority alarms are remotely annunciated. The

nurse call connector is located at the back of the ventilator, as shown. See Figure 49, page 131 .

See the remote alarm manufacturer’s IFU for information regarding proper nurse call connection.

5.5.1.4 USB Ports

The USB ports are used for screen captures, or receiving serial data when a USB port has been configured as a serial port. This is also known as transferring data via a serial over USB protocol. See

Section 5.4.2, Communication Setup, page 120

for Comm setup configuration. Screen captures require an external USB memory storage device (“flash drive”) for screen captures. Instructions for using this port for screen captures are given. See

Section 5.4.1, GUI Screen

Capture, page 119 .

5.5.1.5 HDMI Port

An external display can be used via connection with the HDMI port.

To use the HDMI port with an external display

1. Connect one end of an HDMI cable to the HDMI port at the back of the ventilator ( Figure 49 , item 6).

2. Connect the other end of the cable to the external display. An HDMI to DVI adapter may be used.

3. Turn the device on. The appearance of the GUI now displays on the external display device.

5.5.1.6 Service Port

The service port is used by Covidien-trained service technicians only.

5.6 Retrieving Stored Data

Ventilator data are stored in various logs, accessible using the logs icon.

Some logs may be accessed during normal ventilation, and some are only available to Medtronic personnel when the ventilator is in Service mode. See

Section 8.5, Ventilator Logs, page 187

for more information on data stored in various logs.

5.7 Display Configurability

The operator can configure some ventilator parameters according to personal preference. See Table 17, page 78 for

a table showing which parameters are configurable and by whom.

See

Section 3.8.1, Preparing the Ventilator for Use, page 78

for information on configuring each display item.

5.8 Printing Data or Screen Captures

The ventilator cannot be connected directly to a printer.

Save screen captures to an external storage device, such as a USB flash drive, then print from a PC. See Section 5.4.1,

GUI Screen Capture, page 119

for instructions on using the screen-capture feature.

132

5.9 Connectivity to External Systems

The ventilator is compatible with the Philips Medical IntelliVue MP50 and Spacelabs Ultraview patient monitoring systems.

Note: Not all patient monitors are compatible with the Puritan Bennett 980 Series Ventilator.

133

134

6 Performance

6.1 Overview

This chapter contains detailed information about Puritan Bennett 980 Series Ventilator performance including:

• Ventilator settings

• Alarm interpretation and alarm testing

• A detailed description of selected alarms

• Monitored patient data

6.2 System Options

Various software functions and options are available for the ventilator. Details for each of these functions and options are described in the appendices included in this manual. Information regarding the compressor hardware option is included in the included Compressor Operator’s Manual Addendum.

6.3 Environmental Considerations

Warning: Use of the ventilator/compressor in altitudes higher or barometric pressures lower than those specified

could compromise ventilator/compressor operation. See Section 11.6, Environmental Specifications, page 247

for a complete list of environmental specifications.

6.4 Ventilator Settings

Default ventilator settings are based on the circuit type selected during SST. A neonatal, pediatric or adult patient circuit can be used, and all accessories needed to ventilate the patient should be attached when SST is performed.

6.4.1 Ventilation Type

The clinician enters the ventilation type, specifying how the patient will be ventilated; invasively or non-invasively

(NIV). The ventilation type optimizes the alarm limits for NIV patients, and disables some settings for NIV ventilation.

6.4.2 Mode

Available ventilation modes are mandatory (A/C) or spontaneous (SPONT) modes, as well as two “mixed” modes:

SIMV and BiLevel.

• A/C (Assist-Control) — A/C mode guarantees delivery of a minimum number of mandatory breaths based on the frequency (f ) set by the clinician. Breaths in A/C can be patient-initiated (PIM) or ventilator-initiated

(VIM).

• SPONT (Spontaneous) — SPONT mode delivers only spontaneous breaths which are all patient-initiated.

• SIMV (Synchronized Intermittent Mandatory Ventilation) — SIMV is a mixed mode allowing both mandatory and spontaneous breaths. SIMV guarantees at least one mandatory breath per set breath cycle, which is either patient-initiated or ventilator-initiated. The mandatory type of an SIMV breath can be PC, VC, or VC+.

• BiLevel — BiLevel is also a mixed mode which overlays the patient’s spontaneous breaths onto the breath structure for PC mandatory breaths. Two levels of pressure, P

and P

are employed. The breath cycle interval for both SIMV and BiLevel modes is 60/ f where f is the respiratory rate set by the operator.

• CPAP — CPAP is available only when circuit type is neonatal and ventilation type is NIV. CPAP mode allows spontaneous breathing with a desired PEEP level. To limit inadvertent alarms associated with the absence of returned volumes in nasal CPAP breathing, CPAP does not make available exhaled minute volume and exhaled tidal volume alarm settings.

135

6.4.3 Breath Type

Mandatory breath types for A/C and SIMV modes include volume controlled (VC), pressure controlled (PC), or volume control plus (VC+) breath types, also called mandatory type.

• VC (Volume Control) — The ventilator delivers an operator-set tidal volume.

• PC (Pressure Control) — The ventilator delivers an operator-set pressure.

• VC+ (Volume Control Plus) —Volume control plus (a mandatory, pressure controlled breath type that does not restrict flow during the inspiratory phase, and automatically adjusts the inspiratory pressure target from

breath to breath to achieve the desired tidal volume despite changing lung conditions. See Section 10.7,

Mandatory Breath Delivery, page 206 for more information on VC+.

Mandatory inspirations are triggered in the following ways:

• Pressure Trigger (P-Trig) — Changes in circuit pressure cause the ventilator to deliver a breath. These pressure changes relate to the pressure sensitivity (P

SENS

) set by the operator. If the patient makes an effort to inspire, the airway pressure drops. If the pressure drops by at least the value of P

SENS a breath.

, the ventilator delivers

• Flow Trigger ( ⩒ -Trig) — Changes in flow in the circuit cause the ventilator to deliver a breath. The breath delivery and exhalation flow sensors measure gas flow in the ventilator breathing system. As the patient

( inspires, the delivered flow remains constant, and the exhalation flow sensor measures decreased flow. When the difference between the two flow measurements is at least the operator-set value for flow sensitivity

⩒

SENS

), the ventilator delivers a breath.

• Time Trigger — The ventilator delivers a breath after a specific amount of time elapses.

• Operator Trigger (OIM) — The operator presses the Manual inspiration key. An operator initiated mandatory breath is also called an OIM breath. During an OIM breath, the breath delivered is based on the current settings for a mandatory breath.

Spontaneous breathing modes such as SIMV, BiLevel, and SPONT include the following breath types (called

Spontaneous Types):

• PS (Pressure Support) — The ventilator delivers an operator-set positive pressure above PEEP (or PL in

BiLevel) during a spontaneous breath. If SIMV is selected as the mode, PS is automatically selected for spontaneous type.

• VS (Volume Support) — The ventilator delivers an operator-set positive pressure above PEEP during a spontaneous breath and automatically adjusts the pressure level from breath to breath to consistently deliver the set tidal volume.

• TC (Tube Compensation) — Additional positive pressure delivered to the patient during spontaneous breaths to overcome resistance of the artificial airway.

• PAV+™ (Proportional Assist Ventilation) — A software function that allows the ventilator to reduce the work of breathing (WOB) by assisting the patient’s inspiration by an operator-set amount proportional to the

pressure generated by the patient. See Chapter 14 for more information on PAV+™.

The inspiratory trigger methods for spontaneous breaths are

• Pressure Trigger (P-Trig) — Same as described for mandatory inspiration triggers.

• Flow Trigger ( ⩒ -Trig) — Same as described for mandatory inspiration triggers.

• Operator Trigger (OIM) — Since the operator can only initiate a mandatory breath by pressing the Manual inspiration key, spontaneous mode allows OIMs, but the breath delivered is based on the current settings for an apnea breath.

See

Section 10.4, Inspiration — Detection and Initiation, page 199 for details on the different trigger methods.

136

6.5 Alarms

This manual uses the following conventions when discussing alarms:

A description or name of an alarm without specifying the alarm setting is denoted with an upward or downward pointing arrow ( ↑ or ↓ ) preceding the specific alarm name. An alarm setting is denoted as an upward or downward pointing arrow with an additional horizontal limit symbol ( ⤒ or ⤓ ) preceding the specific alarm. Some alarm conditions actually limit breath delivery such as ↑ P

PEAK

and ↑ V

by truncating inspiration and transitioning to the expiratory phase. These alarm conditions are denoted as alarm limits

. See Table 33, page 139 .

6.5.1 Alarm Messages

Alarms are visually annunciated using an indicator on the top of the GUI for an operator to view from 360 degrees around the ventilator with a radius of four meters (13.1 feet) centered on the visual alarm indicator. If an alarm occurs, this indicator flashes at a frequency and color matching the alarm priority. The alarms also appear as colored banners on the right side of the GUI screen, which can be viewed by the operator from a distance of four meters and at any point within the base of a cone subtended by an angle of 30° to the axis normal to the center of the plane of the monitoring display or visual indication. If an alarm occurs, this indicator appears in the color matching the alarm priority (yellow for low (!) and medium (!!) priority; red for high (!!!) priority). Specific alarm detail

(shown in the alarm message area) is designed for the operator to read from up to one meter from the screen. For

technical alarm and non-technical alarm details, see the respective tables Table 36, page 146 and

Table 38

An alarm is defined as a primary alarm if it is the initial alarm. A dependent alarm arises as a result of conditions that led to the primary alarm. This is also referred to as an augmentation. An augmentation strategy is built into the ventilator software to handle occurrences where the initial cause of the alarm has the potential to precipitate one or more additional alarms. When an alarm occurs, any subsequent alarm related to the cause of this initial alarm augments the initial alarm instead of appearing on the GUI as a new alarm. The initial alarm’s displayed analysis message is updated with the related alarm’s information, and the Alarm Log Event column shows the initial alarm as Augmented .

A primary alarm consists of a base message , analysis message , and a remedy message . The base message describes the primary alarm. The analysis message describes the likely cause of the alarm and may include alarm augmentations. The remedy message provides information on what to do to correct the alarm condition.

Alarm banners, when dragged leftward from the right side of the GUI, display messages for the indicated active alarms.

Figure 50

shows the alarm message format.

137

Figure 50.

Alarm Message Format

1 Base message

2 Analysis message

3 Remedy message

A latched alarm is one whose visual alarm indicator remains illuminated even if the alarm condition has autoreset.

Latched alarm indicators are located on the sides of the omni-directional LED. A latched alarm can be manually reset by pressing the alarm reset key. If no alarms are active, the highest priority latched alarm appears on the omni-directional LED on the GUI. A lockablealarm is one that does not terminate an active audio paused function

(it does not sound an audible alert during an active audio paused function), while a non-lockable alarm cancels the audio paused period and sounds an audible alert. All patient data alarms and the CIRCUIT DISCONNECT alarm are lockable alarms.

Note: When a new lockable alarm occurs, the alarm will not start to sound audibly if the previous lockable alarm was muted.

The following rules define how alarm messages are displayed:

• Primary alarms precede any dependent alarms.

• The system adds dependent alarms to the analysis messages of each active primary alarm with which they are associated. If a dependent alarm resets, the system removes it from the analysis message of the primary alarm.

• The priority level of a primary alarm is equal to or greater than the priority level of any of its active dependent alarms.

• An alarm cannot be a dependent alarm of any alarm that occurs subsequently.

• If a primary alarm resets, any active dependent alarms become primary unless they are also dependent alarms of another active primary alarm. This is due to different reset criteria for primary and dependent alarms.

• The system applies the new alarm limit to alarm calculations from the moment a change to an alarm limit is accepted.

• The priority level of a dependent alarm is based solely on its detection conditions (not the priority of any associated alarms.

• When an alarm causes the ventilator to enter OSC, or safety valve open (SVO), the patient data display

(including waveforms) is blanked. The elapsed time without ventilatory support (that is, since OSC, or SVO

138

6 began) appears on the GUI screen. If the alarm causing OSC, or SVO is autoreset, the ventilator resets all patient data alarm detection algorithms.

Table 33.

Alarm Descriptions and Symbols

Alarm description

High compensation pressure

High delivered oxygen percentage

High exhaled minute volume

High exhaled minute volume setting

High exhaled tidal volume

High exhaled tidal volume setting

High inspired tidal volume limit

High internal ventilator pressure

High respiratory rate

High respiratory rate setting

High spontaneous inspiratory time

High spontaneous inspiratory time limit

High circuit pressure

High circuit pressure limit

Low circuit pressure

Low circuit pressure setting

Low exhaled mandatory tidal volume

Low exhaled mandatory tidal volume setting

Low exhaled minute volume

Low exhaled minute volume setting

Low exhaled spontaneous tidal volume

Low exhaled spontaneous tidal volume setting

Low delivered oxygen percentage

Symbol

↑ P

COMP

↑ O

↑ ⩒

E TOT

⤒⩒

E TOT

↑ V

⤒ V

↑ P

VENT

↑ f

TOT

⤒ f

TOT

↑ T

I SPONT

⤒ T

I SPONT

↑ P

PEAK

⤒ P

PEAK

↓ P

PEAK

⤓ P

PEAK

↓ V

TE MAND

⤓ V

TE MAND

↓ ⩒

E TOT

⤓⩒

E TOT

↓ V

TE SPONT

⤓ V

TE SPONT

↓ O

6.5.2 Alarm Reset Key

The alarm reset function can be used for any non-technical alarm.

See

Section 6.5.8, Alarm Handling, page 144 for an explanation of

technical vs. non-technical alarms . Alarm reset reinitializes the algorithm the ventilator uses to initially detect the alarm except for A/C POWER LOSS,

COMPRESSOR INOPERATIVE, LOW BATTERY, NO AIR SUPPLY, NO O again. The ventilator logs all actuations of the alarm reset key.

SUPPLY, PROCEDURE ERROR alarms and active battery alarms. If the cause of the alarm still exists after the Alarm Reset key is pressed, the alarm becomes active

6.5.3 Audio Paused Key

Warning: Do not pause, disable, or decrease the volume of the ventilator’s audible alarm if patient safety could be compromised.

The audio paused feature temporarily mutes the audible portion of an alarm for 2 minutes.

139

After the 2-minute period, if the alarm condition still exists, the alarm sounds again. Pressing the audio paused key again re-starts the 2 minute interval during which an alarm is muted. An LED within the key illuminates and a count-down timer appears on the GUI next to an audio paused indicator symbol, indicating an active audio paused function. The audio paused feature does not allow the audible alarm to be turned off; the audible portion of the alarm is temporarily muted for 2 minutes. The GUI’s omni-directional LED flashes during an active alarm state, and during an audio paused period and its appearance changes with the priority if the alarm escalates.

Pressing the alarm reset key cancels an audio paused condition. If the condition that caused the alarm still exists, the alarm activates again.

6.5.4 Alarm Volume Key

An alarm volume key is available for setting the desired alarm volume.

The alarm volume is automatically set to the factory default setting of 10 (maximum) or to the institutional default setting based on circuit type if it has been so configured. When setting the alarm volume, a sample tone is generated, allowing the practitioner to decide the appropriate alarm volume for the surrounding ambient conditions. If a high priority alarm occurs, the alarm volume increases one increment from its current volume level if it is not acknowledged within 30 s. If a high priority alarm is not acknowledged within 60 s, the audible alarm volume escalates to its maximum volume.

See

Section 3.8.2.6, Alarm Volume, page 81

for instructions on adjusting the alarm volume.

Warning: The audio alarm volume level is adjustable. The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels. See

Section 3.8.2.6, Alarm Volume, page 81

6.5.5 Alarm Testing

Testing the alarms requires oxygen and air sources and stable AC power. To verify the alarm system the operator needs to be standing in front of the ventilator. Test the alarms at least every 12 months, using the procedures described.

Required Equipment

• Test lung (P/N 4-000612-00)

• Adult patient circuit

If the alarm does not annunciate as indicated, verify the ventilator settings and repeat the test. The alarm tests check the operation of the following alarms:

• CIRCUIT DISCONNECT

• LOW EXHALED MANDATORY TIDAL VOLUME ( ↓ V

TE MAND

)

• LOW EXHALED TOTAL MINUTE VOLUME ( ↓ ⩒

E TOT

)

• HIGH CIRCUIT PRESSURE ( ↑ P

PEAK

)

• SEVERE OCCLUSION

• AC POWER LOSS

• APNEA

• LOW EXHALED SPONTANEOUS TIDAL VOLUME ( ↓ V

TE SPONT

)

• NO O

SUPPLY

• LOW DELIVERED O

% ( ↓ O

• HIGH DELIVERED O

% ( ↑ O

140

Ventilator setup for alarms tests

1. Disconnect the patient circuit from the ventilator and turn the ventilator off for at least 5 minutes.

2. Turn the ventilator or on. The ventilator runs POST.

3. On the GUI, select New Patient.

4. Set up new patient using the following settings.

PBW : 70 kg

Ventilation type : Invasive

Mode : A/C

Mandatory type : VC

Trigger type : ⩒ -Trig

5. Set the following new patient settings f : 6.0 1/min

: 500 mL

⩒

MAX

: 30 L/min

: 0 s

Flow pattern : SQUARE

⩒

SENS

: 3 L/min

% : 21%

PEEP : 5 cmH

6. Set the following apnea settings

: 10 s f : 6.0 1/min

% : 21%

: 500 mL

7. Set the following alarm settings

⤒ P

PEAK

: 70 cmH

O f

TOT

: OFF

⤓⩒

⤒⩒

E TOT

: 1 L/min

: 3.5 L/min

⤓ V

TE MAND

: 300 mL

⤒ V

TE MAND

: OFF

⤓ V

TE SPONT

: OFF

⤒ V

TE SPONT

: OFF

8. Set the graphics display to a volume-time plot (for use in the APNEA alarm test).

9. Connect an Adult patient circuit to the ventilator and attach a test lung to the patient wye.

Note: To ensure proper test results, do not touch the test lung or patient circuit during the CIRCUIT DISCONNECT alarm test.

CIRCUIT DISCONNECT alarm test

1. Allow the ventilator to deliver at least four breaths. During the inspiratory phase of a breath, disconnect the inspiratory filter from the to patient port. The ventilator annunciates a CIRCUIT DISCONNECT alarm after the inspiratory filter is disconnected.

2. Connect the inspiratory filter to the to patient port to autoreset the alarm.

141

LOW EXHALED MANDATORY TIDAL VOLUME ( ↓ V

TE MAND

) alarm test

Set V

to 225 mL. The ventilator annunciates a LOW EXHALED MANDATORY TIDAL VOLUME ( the third consecutive breath after Accept is touched.

↓ V

TE MAND

) alarm on

LOW EXHALED TOTAL MINUTE VOLUME ( ↓ ⩒

E TOT

) alarm test

Set ⤓⩒

E TOT

alarm limit to 3.45 L/min. The ventilator annunciates a LOW EXHALED TOTAL MINUTE VOLUME ( ↓ ⩒

E TOT alarm on the next breath after Accept is touched.

HIGH CIRCUIT PRESSURE ( ↑ P

PEAK

) alarm test

1. Make the following patient and alarm settings changes.

: 500 mL

⩒

MAX

: 30 L/min

⤒ P

PEAK

: 20 cmH

2. After one breath, the ventilator annunciates a HIGH CIRCUIT PRESSURE ( ↑ P

PEAK sound, check the patient circuit for leaks.

) alarm. If the alarm does not

SEVERE OCCLUSION alarm test

1. Make the following alarm settings change:

⤒ P

PEAK

: 50 cmH

2. Press the alarm reset key to reset all alarms.

3. Adjust D

SENS

to the ⩒

MAX

setting.

4. Disconnect the ventilator breathing circuit from the FROM PATIENT port and block the gas flow.

5. While maintaining the occlusion, ensure the safety valve open indicator appears on the status display, the

GUI shows the elapsed time without normal ventilation support, and the test lung inflates and deflates rapidly with small pulses as the ventilator delivers trial pressure-based breaths.

6. Press the alarm reset key to reset all the alarms.

AC POWER LOSS alarm test

1. Allow the ventilator to deliver at least four breaths, then disconnect the power cord from AC facility power.

If any battery is charged, the GUI annunciates an AC POWER LOSS alarm. If less than 10 minutes of battery backup are available, the GUI annunciates a LOW BATTERY alarm. If no battery power is available, the BDU annunciates a LOSS OF POWER alarm.

2. Connect the power cord to AC facility power. The AC POWER LOSS or LOW BATTERY alarm autoresets.

APNEA alarm test

1. Make the following alarm settings changes:

⤒ P

PEAK

: 70 cmH

Mode : SPONT

Spontaneous type : PS

2. The GUI annunciates an APNEA alarm within 10 s after touching Accept .

3. Squeeze the test lung twice to simulate two subsequent patient-initiated breaths. The APNEA alarm autoresets.

4. Let the ventilator return to apnea ventilation.

Note: To avoid triggering a breath during the apnea interval, do not touch the test lung or patient circuit.

Note: For the apnea alarm test, the exhaled tidal volume (V

) displayed in the patient data area must be greater than half the delivered volume shown on the volume-time plot in the graphics display for apnea to autoreset. See

Section 10.12, Apnea Ventilation, page 220

for a technical description of apnea ventilation.

142

LOW EXHALED SPONTANEOUS TIDAL VOLUME alarm test

1. Make the following patient and alarm settings changes

Trigger type : P-Trig

SENS

: 4 cmH

⤓ V

TE SPONT

: 2500 mL

2. Press the alarm reset key to reset the apnea alarm.

3. Slowly squeeze the test lung to simulate spontaneous breaths. The ventilator annunciates a LOW EXHALED

SPONTANEOUS TIDAL VOLUME ( ↓ V inspiration.

TE SPONT

) alarm at the start of the fourth consecutive spontaneous

4. Make the following patient settings changes:

Mode : A/C

⤓ V

TE SPONT

: OFF

5. Press the alarm reset key to reset the ⤓ V

TE SPONT

alarm.

NO O

SUPPLY alarm test

1. Disconnect the oxygen inlet supply. The ventilator annunciates a NO O

SUPPLY alarm within one breath.

2. Connect the oxygen inlet supply. The NO O

2 reconnected.

SUPPLY alarm autoresets within two breaths after oxygen is

LOW DELIVERED O

% and HIGH DELIVERED O

% alarms tests

1. Make the following patient and alarm settings changes:

SENS

: 2 cmH

% : 100%

2. Make the following apnea settings changes:

: 60 s

3. Attach the ventilator’s oxygen gas hose to a known air supply (for example, a medical grade air cylinder) or a wall air outlet.

4. Attach the ventilator’s air gas hose to a known medical oxygen supply.

5. Observe the GUI screen. The delivered O a medium priority ↓ O

% display should decrease, and the ventilator should annunciate

% alarm within 60 s and a high priority ↓ O

% alarm within 2 minutes.

6. Set the O

% to 21%.

7. Observe the GUI screen. The delivered O a a medium priority ↑ O

% display should increase, and the ventilator should annunciate

% alarm within 60 s and a high priority ↑ O

% alarm within 2 minutes.

8. Remove the air gas hose from the oxygen supply and reconnect the hose to a known medical air supply.

9. Remove the oxygen gas hose from the air supply and reconnect the hose to a known oxygen supply.

10. Press the alarm reset key to clear all alarms.

Warning: Before returning the ventilator to service, review all settings and set appropriately for the patient to be ventilated.

6.5.6 Viewing Alarms

When an alarm occurs, the omni-directional LED at the top of the GUI flashes in a color corresponding to the alarm

priority, an audible series of tones sounds, and an alarm banner displays on the GUI. See Figure 32, page 94

. When the alarm banner appears, it displays its base message. Touching the individual alarm causes an expanded explanation to appear, containing analysis and remedy messages, and may contain a link to the alarm log or the alarms settings screen. Touch the link to display requested information. The omni-directional LED remains steadily

143

lit and may appear multicolored, meaning that multiple alarms with varying priority levels have occurred. During an event that causes multiple alarms, the ventilator simultaneously displays the two highest priority active alarms.

6.5.7 Alarm Delay

6.5.7.1 Determination of an Alarm Condition

The delay time from the moment the alarm condition first occurs until the alarm is annunciated is imperceptible.

6.5.7.2 Delay To or From a Distributed Alarm System

For alarm conditions relayed via the serial port, the overall delay is dependent upon the polling rate of the external device. The delay from the time the serial port is polled by the external device, until the alarm message leaves the serial port does not exceed 3 seconds. An example of an external device is a patient monitor.

6.5.8 Alarm Handling

Current alarm settings are saved in the ventilator’s non-volatile memory (NVRAM) . If the alarm settings are changed by another clinician, those settings become applicable. For example, there are no operator-selectable default alarm settings.

The ventilator system’s alarm handling strategy is intended to

• Detect and call attention to legitimate causes for caregiver concern as quickly as possible, while minimizing nuisance alarms.

• Identify the potential cause and suggest corrective action for certain types of alarms. However, the clinician must make the final decision regarding any clinical action.

• Make it easy to discern an alarm’s priority level.

• Allow quick and easy alarm setup.

Ventilator alarms are categorized as high priority, medium priority, or low priority, and are classified as technical or non-technical.

The ventilator is equipped with two alarms — the primary alarm secondary alarms. The primary alarm annunciates high, medium, and low priority alarms when they occur. The secondary alarm (also named “immediate” priority in

Table 34 ) is a continuous tone alarm and annunciates during vent inop conditions or complete loss of power. This

alarm is powered by a capacitor and lasts for at least 120 seconds.

Table 34

lists alarm priority levels and their visual, audible, and autoreset characteristics. An alarm autoresets when the condition causing the alarm no longer exists.

Table 34.

Alarm Priority

Priority Level

Immediate

High: Immediate atten‐ tion required to ensure patient safety.

Visual indicator

Specific to alarm condi‐ tion or component failure.

Flashing red LED located on the top of the GUI, red alarm banner on GUI screen, red bar next to alarm setting icon on

Alarms screen.

Audible indicator

Continuous tone alarm sounding for at least 120 s .

High-priority audible alarm (a sequence of five tones that repeats twice, pauses, then repeats again).

Autoreset characteris‐ tics

N/A

Visual alarm does not auto reset. Visual alarm indica‐ tors remain steadily illumi‐ nated following an autor‐ eset. The alarm reset key must be pressed to extin‐ guish visual indicator.

144

Table 34.

Alarm Priority (continued)

Priority Level

Medium: Prompt atten‐ tion necessary.

Visual indicator Audible indicator

Flashing yellow LED loca‐ ted on the top of the GUI, yellow alarm banner on

GUI screen, and yellow bar next to alarm setting icon on Alarms screen.

Medium-priority audible alarm (a repeating sequence of three tones).

Autoreset characteris‐ tics

LED indicator turns off and autoreset is entered into the alarm log.

Low: A change in the patient-ventilator system has occurred.

Steadily illuminated yel‐ low LED located on the top of the GUI, yellow alarm banner on GUI screen, and yellow bar next to alarm setting icon on Alarms screen.

Low-priority audible alarm

(two tone, non-repeating).

LED indicator turns off and autoreset is entered into the alarm log.

Normal: Normal ventilator operation

Immediate

Steadily illuminated green

LED located on the top of

GUI, no alarm banner, and white values next to alarm setting icon on Alarms screen.

Status display shows the

GUI has failed.

None.

None

The secondary alarm annunciates a repeating sequence of single tones, since the primary alarm

(part of the GUI) has failed.

None

A technical alarm is one that is caused by a violation of any of the ventilator’s self monitoring conditions, such as failure of POST or a fault detected by the ventilator’s background diagnostic system. This includes faults detected by the ventilator’s background diagnostic system. Technical alarms cannot be reset by pressing the

Alarm Reset key. (See

Section 10.16.4, Background Diagnostic System, page 240 . Technical alarms fall into eight

categories, shown in

Table 35 .

Table 35.

Technical Alarm Categories

Category

Name

Vent-Inop

Priority

High

Exh BUV

Insp BUV

Mix BUV

SVO

Caution

High

System Response

Ventilator goes to safe state. See Section 4.11, Ven‐ tilator Protection Strategies, page 116

Backup ventilation

Ventilator goes to safe state. See Section 4.11, Ven‐ tilator Protection Strategies, page 116

Ventilation continues as set

145

Table 35.

Technical Alarm Categories (continued)

Category

Name

Warning

Notification

Priority

Medium

N/A

System Response

Ventilation continues as set

See

Table 36, page 146 for a list of ventilator technical alarms, their meaning, and what to do if they occur.

See

Table 65 for the settings, ranges, and resolutions of all the ventilator alarms.

Table 36.

Technical Alarms

Alarm message

SENSOR

DEVICE ALERT

2 failed.

Meaning

sensor is out of calibration or has

Various. Technical alarm category is described.

See

Table 35, page 145

. More infor‐ mation for the particular technical alarm can be found in the System diagnostic log, a link to which is pro‐ vided on the expanded alarm ban‐ ner.

What to do

Recalibrate or replace O

sensor.

Follow remedy message displayed on GUI.

A non-technical alarm is an alarm caused due to a fault in the patient-ventilator interaction or a fault in the electrical or gas supplies that the practitioner may be able to alleviate.

Table 37.

Non-technical Alarm Summary

Base message

AC POWER LOSS

Priority Analysis message

Low Operating on vent main battery. N/A

Low Operating on vent main and compressor battery.

Remedy mes‐ sage

N/A

APNEA (patient data alarm)

Medium Apnea ventilation. Breath inter‐

High val > apnea interval.

Extended apnea duration or multiple apnea events.

Check patient

& settings.

Comments

Ventilator automatically switches to battery power.

Power switch ON. AC power not available. Bat‐ tery operating indicator on status display turns on.

Resets when AC power is restored.

The set apnea interval has elapsed without the ven‐ tilator, patient, or operator triggering a breath. Resets after patient initiates a third consecutive breath.

Possible dependent alarm: ↓ ⩒

E TOT

146

Table 37.

Non-technical Alarm Summary (continued)

Base message

CIRCUIT DISCON‐

NECT

COMPLIANCE LIMI‐

TED V

(alarm is not adjustable) (patient data alarm)

Priority

High

Low

Analysis message

No ventilation.

Compliance compensation limit reached.

COMPRESSOR INOP‐

ERATIVE

↑ P

PEAK alarm)

(patient data

Low No compressor air.

Low Last breath ≥ set limit.

Medium Last 3 breaths ≥ set limit.

High Last 4 or more breaths ≥ set limit.

Remedy mes‐ sage

Check patient

Reconnect cir‐ cuit.

Check patient.

Reconnect cir‐ cuit.

Comments

Ventilator has recovered from unintended power loss lasting more than 5 minutes, detects circuit disconnect. The GUI screen displays elapsed time without ventilator support. Resets when ven‐ tilator senses reconnec‐ tion.

Ventilator detects circuit disconnect and switches to Stand-By state; the GUI screen displays elapsed time without ventilator support. Resets when ven‐ tilator senses reconnec‐ tion.

Compliance volume required to compensate delivery of a VC, VC+ or VS breath exceeds the maxi‐ mum allowed for three consecutive breaths.

Check patient and circuit type. Inspired volume may be < set. Check patient and cir‐ cuit type.

Replace com‐ pressor

Check patient, circuit & ET tube.

No compressor ready indi‐ cator on status display.

Measured airway pressure

≥ set limit. Ventilator trun‐ cates current breath unless already in exhala‐ tion. Possible dependent alarms: ↓ V

TE MAND

, ↓ ⩒

↑ f

TOT

E TOT

. Corrective action:

Check patient. Check for leaks, tube type and tube

ID setting. Consider reduc‐ ing % Supp setting or increasing ⤒ P

PEAK

147

Table 37.

Non-technical Alarm Summary (continued)

↑

↓

Base message

COMP alarm)

PEAK alarm)

(patient data

Priority

Low Last spont breath ≥ set P

PEAK

Medium Last 3 spont breaths ≥ set P

PEAK

High

Low

High

Last 4 or more spont breaths

≥ set P

Analysis message limit–5 cmH limit–5 cmH

PEAK

limit–5 cmH

Last 2 breaths, pressure ≤ set limit.

Medium Last 4 breaths, pressure ≤ set limit.

Last 10 or more breaths, pres‐ sure ≤ set limit.

Remedy mes‐ sage

Comments

In TC and

PAV+™: Check for leaks, tube type, and tube

ID setting.

Pressure of spontaneous breaths ≥ set limit. Possi‐ ble dependent alarms:

↓ V

TOT

TE SPONT

, ↓ ⩒

E TOT

, ↑ f

↓ V

TE SPONT

Corrective action:

Check for leaks.

Check for the correct tube type.

Check that the tube inside diameter corresponds to the patient PBW.

Check the ⤒ P

PEAK

setting.

Check for leaks. Peak inspiratory pressure

≤ alarm setting. (Available only when mandatory type is VC+* or when ven‐ tilation type is NIV. Target pressure = the low limit:

PEEP +3 cmH

O. Ventilator cannot deliver target vol‐ ume. Possible dependent alarms:

↑ f

TOT

Corrective action:

Check patient and set‐ tings.

* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall below

PEEP +3 cmH

O, attempting to set the ⤓ P

PEAK

alarm limit at or below this level will turn the alarm off.

↑ O

% (patient data alarm)

Medium Measured O

2 but <2 min.

% > set for ≥30 s

High Measured O

% > set for ≥2 min.

Check patient, gas sources, O tilator.

2 analyzer & ven‐

The O

% measured during any phase of a breath cycle is 7% (12% during the first hour of operation) or more above the O

% setting for at least 30 seconds. (These percentages increase by

5% for 4 minutes following a decrease in the O ting.)

% set‐

↓ O

% (patient data alarm)

High Measured O

% < set O

Check patient, gas sources, O tilator.

2 analyzer & ven‐

The O

% measured during any phase of a breath cycle is 7% (12% during the first hour of operation) or more below the O

% setting for at least 30 seconds, or below 18%. (These per‐ centages increase by 5%

148

Table 37.

Non-technical Alarm Summary (continued)

Base message Priority

High ⩒

E TOT

Analysis message

↑ V

TE alarm

(patient data Low Last 2 breaths ≥ set limit.

Medium Last 4 breath s ≥ set limit.

High Last 10 or more breaths ≥ set limit.

↑ alarm)

↑ f

⩒

E TOT

TOT

(patient data

(patient data alarm)

Low ⩒

E TOT

≥ set limit for ≤30 s .

Medium ⩒

E TOT

≥ set limit for >30 s .

≥ set limit for >120 s .

Low f

TOT

≥ set limit for ≤30 s .

Medium f

TOT

High f

TOT

≥ set limit for >30 s .

≥ set limit for >120 s .

Remedy mes‐ sage

Comments

Check settings, changes in patient’s R&C.

Check patient and settings.

Check patient

& settings.

for 4 minutes following an increase in the O ting.)

% set‐

Exhaled tidal volume ≥ set limit. Alarm updated whenever exhaled tidal volume is recalculated.

Possible dependent alarm: ↑ ⩒

E TOT

Expiratory minute volume

≥ set limit. Alarm updated whenever an exhaled minute volume is recalcu‐ lated. Possible dependent alarm: ↑ V

Total respiratory rate ≥ set limit. Alarm updated at the beginning of each inspira‐ tion. Reset when meas‐ ured respiratory rate falls below the alarm limit. Pos‐ sible dependent alarms:

↓ V

TE MAND

↓ ⩒

E TOT

, ↓ V

TE SPONT

149

Table 37.

Non-technical Alarm Summary (continued)

↑ P

Base message

VENT alarm)

(patient data

INOPERATIVE BAT‐

TERY

INOPERATIVE BAT‐

TERY

INOPERATIVE BAT‐

TERY

Priority

Low

High

Analysis message

1 breath ≥ limit.

Medium 2 breaths ≥ limit.

3 or more breaths ≥ limit.

Low Inadequate charge or non-func‐ tional ventilator battery system.

Low Inadequate charge or non-func‐ tional compressor battery sys‐ tem.

Low Inadequate charge or nonfunc‐ tional ventilator battery system.

Inadequate charge or nonfunc‐ tional compressor battery sys‐ tem.

Serv‐ ice/replace ventilator bat‐ tery.

Serv‐ ice/replace compressor battery sys‐ tem.

Serv‐ ice/replace ventilator bat‐ tery.

Serv‐ ice/replace compressor battery.

Remedy mes‐ sage

Check patient, circuit & ET tube.

Comments

Inspiratory pressure

>110 cmH

O and manda‐ tory type is VC or sponta‐ neous type is TC or PAV+™.

Ventilator truncates cur‐ rent breath unless already in exhalation. Possible dependent alarms: ↓ V

MAND

, ↓ ⩒

E TOT

, ↑ f

TOT

Corrective action:

• Check the patient for agitation. Agitated breathing, combined with high % Supp set‐ ting in PAV+™ can cause over-assis‐ tance. Consider reducing % Supp set‐ ting.

• Provide alternate ven‐ tilation. Remove ven‐ tilator from use and contact Service.

Battery installed but not functioning or charging for ≥6 hours. Resets when battery is functional.

150

Table 37.

Non-technical Alarm Summary (continued)

Base message

INOPERATIVE BAT‐

TERY

INOPERATIVE BAT‐

TERY

INOPERATIVE BAT‐

TERY

INSPIRATION TOO

LONG (patient data alarm)

PAV STARTUP TOO

LONG (patient data alarm) (occurs only if

PAV+™ is in use)

Priority Analysis message

Medium Inadequate charge or nonfunc‐

Low Last 2 spont breaths = PBW based T

limit.

Medium Last 4 spont breaths = PBW based T

limit.

High Last 10 or more spont breaths =

PBW based T

limit.

Low

High tional ventilator battery system.

tional compressor battery sys‐ tem.

tional ventilator battery system.

Inadequate charge or nonfunc‐ tional compressor battery sys‐ tem.

PAV startup not complete for

≥45

≥90 s s

Medium PAV startup not complete for

PAV startup not complete for

≥120 s .

Remedy mes‐ sage

Serv‐ ice/replace ventilator bat‐ tery.

Serv‐ ice/replace compressor battery sys‐ tem.

Serv‐ ice/replace ventilator bat‐ tery.

Serv‐ ice/replace compressor battery.

Check patient.

Check for leaks.

Check for leaks, shallow breathing, & settings for

↑ V

↑ P

and

PEAK

Comments

Defective battery detec‐ ted. Corrective action replace battery as soon as possible.

Inspiratory time for spon‐ taneous breath

≥ PBW-based limit. Venti‐ lator transitions to exhala‐ tion. Resets when T

falls below PBW-based limit.

Active only when ventila‐ tion type is Invasive.

Unable to assess patient’s resistance and compli‐ ance during PAV startup.

Possible dependent alarms ↓ V

TE SPONT

, ↓ ⩒

E TOT

↑ f

TOT

. Corrective action:

Check patient. (Patient’s inspiratory times may be too short to evaluate resistance and compli‐ ance.) Check that selected humidification type and empty humidifier volume are correct.

151

Table 37.

Non-technical Alarm Summary (continued)

Base message

PAV R & C NOT

ASSESSED (patient data alarm) (occurs only if PAV+™ is in use)

Priority Analysis message Remedy mes‐ sage

Low R and/or C over 15 minutes old. Check for leaks,

Medium R and/or C over 30 minutes old.

shallow breathing, & settings for tube ID, ↑ V and ↑ P

PEAK

LOSS OF POWER

LOW BATTERY

Immedi‐ ate

N/A N/A

Comments

Unable to assess resist‐ ance and/or compliance during PAV+™ steadystate. Startup was success‐ ful, but later assessments were unsuccessful. Cor‐ rective action: Check patient. (Patient’s inspira‐ tory times may be too short to evaluate resist‐ ance and compliance.)

Check that selected humidification type and empty humidifier volume are correct.

The ventilator power switch is on and there is insufficient power from

AC and the battery. There may not be a visual indi‐ cator for this alarm, but an independent audio alarm sounds for at least 120 sec‐ onds. Alarm annunciation can be reset by turning power switch to the off position.

Resets when battery has

≥10 minutes of opera‐ tional time remaining.

LOW BATTERY

Medium Vent main battery operational time <10 minutes.

Medium Compressor battery operational time <10 minutes.

Medium Vent main battery operational time <10 minutes and compres‐ sor battery operational time <10 minutes.

Replace or allow recharge vent main bat‐ tery.

Replace or allow recharge compressor battery.

Replace or allow recharge vent main bat‐ tery and com‐ pressor bat‐ tery.

Resets when main battery or compressor battery has

≥10 minutes of opera‐ tional time remaining or when AC power is restored.

152

Table 37.

Non-technical Alarm Summary (continued)

LOW BATTERY

↓ V

Base message

TE MAND data alarm)

(patient

Priority

High

Analysis message

Vent main battery operational time <5 minutes.

Compressor battery operational time <5 minutes.

Vent main battery operational time <5 minutes and compres‐ sor battery operational time <5 minutes.

Remedy mes‐ sage

Replace or allow recharge vent main bat‐ tery.

Replace or allow recharge compressor battery.

Replace or allow recharge vent main bat‐ tery and com‐ pressor bat‐ tery.

Low Last 2 mand breaths ≤ set limit. Check for leaks,

Medium Last 4 mand breaths ≤ set limit.

changes in patient’s R & C.

High Last 10 or more mand breaths ≤ set limit.

↓

↑

TE SPONT data alarm)

TI alarm)

(patient

(patient data

Low Last 4 spont breaths ≤ set. limit Check patient

Medium Last 7 spont breaths ≤ set limit.

High Last 10 or more spont breaths ≤ set limit.

& settings.

Low Last spont breath ≥ set limit.

In TC, VS, or

Medium Last 3 spont breaths ≥ set limit.

High Last 4 or more spont breaths

≥ set limit.

PAV+™:

Check patient and settings.

Comments

Resets when battery has

≥5 minutes of operational time remaining or when

AC power is restored.

Resets when battery has

≥5 minutes of operational time remaining or when

AC power is restored.

Exhaled mandatory tidal volume.≤ set limit. Alarm updated whenever exhaled mandatory tidal volume is recalculated.

Possible dependent alarms: ↓ ⩒

E TOT

, ↑ f

TOT

Exhaled spontaneous tidal volume ≤ set limit. Alarm updated whenever exhaled spontaneous tidal volume is recalculated.

Possible dependent alarms: ↓ ⩒

E TOT

, ↑ f

TOT

Delivered inspiratory vol‐ ume ≥ inspiratory limit.

Ventilator transitions to exhalation. Possible dependent alarms: ↓ V

SPONT

, ↓ ⩒

E TOT

, ↑ f

Corrective action:

TOT

Check for leaks.

Check for the correct tube type.

Check the V

PAV

or V

setting.

In PAV+™, check for patient agitation, which can cause miscalculation of R

PAV

and

. Consider reducing %

Supp setting. Check ⤒ V

153

Table 37.

Non-technical Alarm Summary (continued)

↓ ⩒

Base message

E TOT alarm) alarm)

(patient data

VOLUME NOT DELIV‐

ERED (not adjusta‐ ble) (patient data

Priority

Low ⩒

Medium ⩒

High

Low

⩒

E TOT

Analysis message

≤ set limit for ≤30

≤ set limit for >30 s s

≤ set limit for >120

s .

Last 2 spont (or mand) breaths pressure > max allowable level.

Medium Last 10 or more spont (or mand) breaths, pressure > max allowa‐ ble level.

Remedy mes‐ sage

Check patient

& settings.

Check patient and setting for

↑ P

PEAK

Comments

Total minute volume ≤ set limit. Alarm updated whenever exhaled minute volume is recalculated.

Possible dependent alarms ↓ V

TE MAND

, ↓ V

SPONT

, ↑ f

TOT

Insp target pressure >

PEAK

– PEEP–3 cmH

O), when spontaneous type is

VS or mandatory type is

VC+, the ventilator cannot deliver target volume. Pos‐ sible dependent alarms:

For VC+ breaths: ↓ V

MAND

, ↓ ⩒

E TOT

, ↑ f breaths: ↓ V

TE SPONT

↓ ⩒

E TOT

, settings.

↑ f

TOT

. For VS

Corrective action: Check patient and

Ventilator delivers 100%

. Air supply pressure

≤ 17 psig. Resets if air sup‐ ply pressure ≥35 psig is connected.

NO AIR SUPPLY

Low Compressor inoperative. Venti‐ lation continues as set. Only O available.

High Compressor inoperative. Venti‐ lation continues as set, except

% = 100.

Low Ventilation continues as set.

Only air available.

Check air source.

Check patient air source.

NO O

SUPPLY

High Ventilation continues as set, except O

% =21.

Check O source.

Check patient

& O

source.

PROCEDURE ERROR High Patient connected before setup complete.

SEVERE OCCLUSION High Little/no ventilation.

Provide alter‐ nate ventila‐ tion. Complete setup process.

Check patient.

Provide alter‐ nate ventila‐ tion. Clear occlusions; drain circuit.

Operator-set O

21%. Resets if O

2 connected.

% equals

supply

Ventilator delivers 21% O instead of set O

%. Resets

2 if oxygen supply connec‐ ted.

Ventilator begins safety ventilation. Resets when ventilator startup proce‐ dure is complete.

Ventilator enters occlu‐ sion status cycling (OSC).

Patient data displays are blanked and GUI screen displays elapsed time without ventilator sup‐ port.

154

Table 37.

Non-technical Alarm Summary (continued)

Base message

INADVERTENT

POWER OFF

PROX INOPERATIVE

Priority

High

Low

Analysis message

Ventilator switched OFF with patient connected to breathing circuit.

Data from proximal flow sensor is not being used.

Remedy mes‐ sage

Return power switch to ON position and disconnect patient before turning power off.

Check proxi‐ mal flow sen‐ sor connec‐ tions and tubes for occlusions or leaks.

Comments

User must acknowledge turning the power off by touching Power Off on the

GUI.

Data for real time wave‐ forms and monitored vol‐ umes are obtained from internal sensors.

Table 38.

Non-Technical Alarms and Suggested Responses

Alarm message

AC POWER LOSS

Meaning

The ventilator/and or compressor is running on battery power.

What to do

Monitor the battery charge level to ensure there is enough power remaining to operate the ventila‐ tor/compressor.

Check patient and settings.

APNEA (patient data alarm)

CIRCUIT DISCONNECT

Compliance limited V

T alarm)

(patient data

COMPRESSOR INOPERATIVE

↑ P

PEAK

(patient data alarm)

The time between patient breaths exceeds the set apnea interval.

The patient circuit has become dis‐ connected or there is a large leak in the patient circuit.

Compliance volume required to compensate delivery of a VC, VC+, or VS breath exceeds the maximum allowed for three consecutive breaths.

Air pressure not detected in the compressor’s accumulator. Status display indicates the compressor is inoperative

The measured airway pressure is

≥ set limit. Reduced tidal volume likely.

↓ P

PEAK

(patient data alarm)

Reconnect the patient circuit, or eliminate the leak.

Check patient and circuit type.

Inspired volume may be less than set.

Service or replace compressor.

The peak inspiratory pressure in the patient circuit ≤ alarm setting. This alarm is only available when NIV is the selected ventilation type or when VC+ is the selected manda‐ tory type during Invasive ventila‐ tion.*

• Check the patient

• Check the patient circuit

• Check the endotracheal tube

Check for leaks in the patient circuit and VBS.

155

Table 38.

Non-Technical Alarms and Suggested Responses (continued)

Alarm message Meaning What to do

* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall below

PEEP +3 cmH

O, attempting to set the ⤓ P

PEAK

alarm setting at or below this level will turn the alarm off.

↑ O

% (patient data alarm) The O

% measured during any phase of a breath cycle is 7% (12% during the first hour of operation) or more above the O

% parameter for at least 30 seconds. The percentage window increases by 5% for 4 minutes after increasing the set

% value.

Check the patient, the air and oxy‐ gen supplies, the oxygen analyzer, and the ventilator.

↓ O

% (patient data alarm) The O

% measured during any phase of a breath cycle is 7% (12% during the first hour of operation) or more below the O

% parameter for at least 30 seconds. The percentage window increases by 5% for 4 minutes after increasing the set

% value.

• Check the patient, the air and oxygen supplies, the oxygen analyzer, and the ventilator.

• Calibrate the oxygen sensor.

See

Section 4.10.2, Oxygen Sen‐ sor Calibration, page 115

for details regarding calibrating the oxygen sensor.

↑ V

(patient data alarm) Exhaled tidal volume ≥ alarm set‐ ting for the last two breaths.

• Use an external O

2 disable the O

monitor and

sensor.

• Check patient settings.

↑ ⩒

E TOT

(patient data alarm)

↑ f

TOT

(patient data alarm)

Minute volume ≥ alarm setting.

• Check for changes in the patient’s resistance and com‐ pliance.

Check patient settings.

↑ P

VENT

(patient data alarm)

The breath rate from all breaths is ≥ alarm setting.

The inspiratory pressure transducer has measured a pressure

>110 cmH

O in VC, TC, or PAV+™.

The ventilator transitions to exhala‐ tion. A reduced tidal volume is likely.

Check the patient and the ventilator settings.

• Check the patient, the patient circuit (including filters), and the endotracheal tube. Ensure the ET tube ID is the correct size.

Check the ventilator flow and volume settings.

INOPERATIVE BATTERY

• Rerun SST.

• Obtain an alternate ventilation source.

• Remove the ventilator from clinical use and obtain service.

Replace inoperative battery.

INSPIRATION TOO LONG (patient data alarm)

Alarm indicates unable to charge battery or the battery system is non‐ functional.

The PBW-based inspiratory time for the last two spontaneous breath exceeds the ventilator-set limit.

Active only when ventilation type is

Invasive.

• Check the patient.

• Check the patient circuit for leaks.

• Check the rise time% and E settings.

SENS

156

Table 38.

Non-Technical Alarms and Suggested Responses (continued)

Alarm message

LOSS OF POWER

LOW BATTERY

↓

↑

⩒

TE MAND

TE SPONT

E TOT

(patient data alarm)

NO AIR SUPPLY

NO O

(patient data alarm)

SUPPLY

COMP

Meaning

The ventilator power switch is ON, but there is insufficient power from the mains AC and the battery. There may not be a visual indicator for this alarm, but an independent audio alarm (immediate priority) sounds for at least 120 seconds.

Medium priority alarm indicating

<10 minutes of battery power remaining to operate the ventilator or compressor. High priority alarm indicating <5 minutes of battery power remain to operate the venti‐ lator or compressor.

The patient’s exhaled mandatory tidal volume is ≤ alarm setting for the last two mandatory breaths.

What to do

• Check the integrity of the AC power and battery connec‐ tions. Obtain alternate ventila‐ tion, if necessary.

• Install an extended battery.

• Turn the power switch off to reset the alarm.

Recharge the battery, by plugging the ventilator into AC power or replace the battery, or install an extended battery.

• Check the patient.

• Check for leaks in the patient circuit.

• Check for changes in the patient’s resistance or compli‐ ance.

The patient’s exhaled spontaneous tidal volume is ≤ alarm setting for the last two spontaneous breaths.

The minute volume for all breaths is

≤ alarm setting.

• Check the patient.

• Check the ventilator settings.

• Check the patient.

The air supply pressure is less than the minimum pressure required for correct ventilator operation. The ventilator delivers 100% O

if avail‐ able. If an oxygen supply is not avail‐ able, the safety valve opens. The ventilator displays the elapsed time without ventilator support. This alarm cannot be set or disabled.

• Check the ventilator settings.

• Check the patient.

• Check the air and oxygen sour‐ ces.

• Obtain alternate ventilation if necessary.

The oxygen supply pressure is less than the minimum pressure required for correct ventilator oper‐ ation. The ventilator delivers 100% air if available. If an air supply is not available, the safety valve opens.

The ventilator displays the elapsed time without ventilatory support.

This alarm cannot be set or disabled.

• Check the patient.

• Check the air and oxygen sour‐ ces.

• Obtain alternate ventilation, if necessary.

Target pressure ≥ ( ⤒ P

PEAK

–5 cmH

O) In TC

Check for leaks, tube type, and tube

ID setting.

In PAV+™

157

Table 38.

Non-Technical Alarms and Suggested Responses (continued)

PROCEDURE ERROR

SEVERE OCCLUSION

↑ V

Alarm message

(patient data alarm)

VOLUME NOT DELIVERED (patient data alarm)

Meaning

The patient is attached before ven‐ tilator startup is complete. Safety ventilation is active.

The patient circuit is severely occlu‐ ded. The ventilator enters occlusion status cycling. The elapsed time without ventilatory support appears.

Delivered inspiratory volume ≥ high inspiratory volume limit.

What to do

Limit target pressure to

⤒ P

PEAK

–5 cmH

• Provide alternate ventilation, if necessary.

• Complete ventilator startup procedure.

• Check the patient.

• Obtain alternate ventilation, if necessary.

• Check the patient circuit for bulk liquid, crimps, blocked fil‐ ter.

• If problem persists, remove the ventilator from use and obtain service.

Ventilator transitions to exhalation.

• Check for leaks, tube type, and tube ID setting, % Supp setting, and patient agitation

• Check the patient and ventila‐ tor settings.

Check patient and ↑ P

PEAK

setting.

PAV STARTUP TOO LONG (occurs only if PAV+™ is in use)

PAV R & C NOT ASSESSED (occurs only if PAV+™ is in use)

PROX INOPERATIVE

Insp target pressure >

PEAK

–PEEP–3 cmH

O), when spontaneous type is VS or when mandatory type is VC+.

Unable to assess resistance or com‐ pliance during PAV+™ startup.

Unable to assess resistance or com‐ pliance during PAV+™ steady-state.

A malfunction occurred with the proximal flow sensor or the pneu‐ matic lines are occluded.

Check for leaks, shallow breathing, and settings for

↑ P

PEAK

↑ V

and ↑ P

PEAK

Check for leaks, shallow breathing, and settings for tube ID, ↑ V

and

Replace the proximal flow sensor or purge its pneumatic lines. Does not affect data from the ventilator’s delivery or exhalation flow sensors.

The next sections provide detailed descriptions of selected alarms.

6.5.9 AC POWER LOSS Alarm

The AC POWER LOSS alarm indicates the ventilator power switch is on and the ventilator is being powered by the battery and an alternate power source may soon be required to sustain normal ventilator operation. The ventilator annunciates a medium-priority LOW BATTERY alarm when the ventilator has less than 10 minutes of battery power remaining. The ventilator annunciates a high-priority LOW BATTERY alarm when less than 5 minutes of battery power are estimated available.

The compressor is a DC device, in which AC power is converted to DC power, and it has its own primary and extended batteries (if the extended battery was purchased). If AC power is lost, there is no conversion to DC power

158

6 for the compressor as in normal operation, but the compressor supplies air, providing the charge level of its batteries is sufficient.

6.5.10 APNEA Alarm

The APNEA alarm indicates neither the ventilator nor the patient has triggered a breath for the operator-selected apnea interval (T

). T

is measured from the start of an inspiration to the start of the next inspiration and is based on the ventilator’s inspiratory detection criteria. T

can only be set via the apnea ventilation settings.

The APNEA alarm autoresets after the patient initiates two successive breaths, and is intended to establish the patient’s inspiratory drive is reliable enough to resume normal ventilation. To ensure the breaths are patient-initiated (and not due to autotriggering), exhaled volumes must be at least half the V

T returning to normal ventilation if there is a disconnect).

(this avoids

6.5.11 CIRCUIT DISCONNECT Alarm

The CIRCUIT DISCONNECT alarm indicates the patient circuit is disconnected at the ventilator or the patient side of the patient wye, or a large leak is present. The methods by which circuit disconnects are detected vary depending on breath type. Time, pressure, flow, delivered volume, exhaled volume, and the D discussion of the CIRCUIT DISCONNECT detection methods.

SENS

setting may be

used in the circuit disconnect detection algorithms. See Section 10.13.2, Disconnect, page 224 for a complete

The CIRCUIT DISCONNECT alarm sensitivity is adjusted via the D

SENS

setting. During a CIRCUIT DISCONNECT condition, the ventilator enters an idle state and delivers a base flow of oxygen to detect a reconnection.

When the ventilator determines the patient circuit is reconnected, the CIRCUIT DISCONNECT alarm autoresets and normal ventilation resumes without having to manually reset the alarm (for example, following suctioning).

A disconnected patient circuit interrupts gas delivery and patient monitoring. Notification of a patient circuit disconnect is crucial, particularly when the patient cannot breathe spontaneously. The ventilator does not enter apnea ventilation when a disconnect is detected to avoid changing modes during a routine suctioning procedure.

Note: When utilizing a closed-suction catheter system, the suctioning procedure can be executed using existing mode, breath type and settings. To reduce potential for hypoxemia during the procedure, elevate the oxygen concentration using the Elevate O

control. See Section 3.8.2.5, Elevate O

, page 80

6.5.12 LOSS OF POWER Alarm

This alarm alerts the operator that there is insufficient battery power and no AC power to support ventilator or compressor operation. The alarm annunciates as long as the ventilator’s power switch is in the ON position, and lasts for at least 120 seconds.

6.5.13 DEVICE ALERT Alarm

A DEVICE ALERT alarm indicates a background test or power on self test (POST) has failed. Depending on which test failed, the ventilator either declares an alarm and continues to ventilate according to current settings, or ventilates with modified settings, or enters the ventilator inoperative state. The DEVICE ALERT alarm relies on the

ventilator’s self-testing and notifies the clinician of an abnormal condition requiring service. See Section 10.16.4,

Background Diagnostic System, page 240

6.5.14 HIGH CIRCUIT PRESSURE Alarm

The ↑ P

PEAK

⤒ P

PEAK

alarm indicates the currently measured airway pressure is equal to or greater than the set limit. The

limit is active during all breath types and phases to provide redundant patient protection (for example, to detect air flow restrictions downstream of the pressure-sensing device). The ↑ P ventilation modes. The ⤒ P and adult patients. The ⤒ P

PEAK

limit is not active during a SEVERE OCCLUSION alarm.

limit is active in all normal

alarm new patient default values are separately configurable for neonatal, pediatric,

159

The ↑ P

PEAK

alarm truncates inspiration and transitions the ventilator into the expiratory phase and the limit cannot be set less than

• PEEP +7 cmH

• PEEP + P

+2 cmH

• PEEP + P

SUPP

+2 cmH

• ≤ ⤓ P

PEAK

The ⤒ P

PEAK

limit cannot be disabled. The ventilator phases in changes to the ⤒ P

PEAK

limit immediately to allow prompt notification of a high circuit pressure condition.

The minimum ⤒ P

PEAK

limit (7 cmH

O) corresponds to the lowest peak pressures not due to autotriggering anticipated during a mandatory breath. The maximum ⤒ P

PEAK

limit (100 cmH maximum pressure required to inflate very low-compliance lungs.

O) was selected because it is the

The ventilator allows circuit pressure to rise according to a computed triggering profile for the initial phase of PC and PS breaths without activating the ⤒ P

PEAK

alarm. This triggering profile helps avoid nuisance alarms due to possible transient pressure overshoot in the airway when aggressive values of rise time% are selected. A brief pressure overshoot measured in the patient circuit is unlikely to be present at the carina.

6.5.15 HIGH DELIVERED O

% Alarm

The ↑ O

% alarm indicates the measured O

30 seconds to eliminate transient O

% is at or above the error percentage above the O

% delivery variation nuisance alarms. The ↑ O

2 in ventilator gas delivery or oxygen monitor. The ventilator declares a ventilator automatically sets the ↑ O

↑ O

% setting for at least

% alarm detects malfunctions

% alarm after 30 seconds. Although the

% alarm limits, the oxygen sensor can be disabled. (The error percentage is

12% above setting for the first hour of ventilator operation, 7% above the setting after the first hour of operation, and an additional 5% above the setting for the first 4 minutes following a decrease in the setting.)

The ventilator automatically adjusts the ↑ O

% alarm limit when O

2 occlusion, circuit disconnect, or a NO AIR/O

2 measured oxygen percentage at 1-second intervals.

% changes due to 100% O

SUPPLY alarm. The ventilator checks the ↑ O

, apnea ventilation,

% alarm limit against the

6.5.16 HIGH EXHALED MINUTE VOLUME Alarm

The ↑ ⩒

E TOT

alarm indicates the measured exhaled total minute volume for spontaneous and mandatory breaths is equal to or greater than the alarm setting. The ↑ ⩒

E TOT

alarm is effective immediately upon changing the setting, to ensure prompt notification of prolonged high tidal volumes.

The ↑ ⩒

E TOT

alarm can be used to detect a change in a patient’s breathing pattern, or a change in compliance or resistance. The ↑ ⩒

E TOT hypocarbia.

alarm can also detect too-large tidal volumes, which could lead to hyperventilation and

6.5.17 HIGH EXHALED TIDAL VOLUME Alarm

The ↑ V

alarm indicates the measured exhaled tidal volume for spontaneous and mandatory breaths is equal to or greater than the set ↑ V

alarm. The ↑ V

alarm is updated whenever a new measured value is available.

The ↑ V

alarm can detect increased exhaled tidal volume (due to greater compliance and lower resistance) and prevent hyperventilation during pressure control ventilation or pressure support. Turn the ↑ V avoid nuisance alarms. (Hyperventilation due to increased compliance is not a concern during volume-based ventilation, because the tidal volume is fixed by the clinician’s choice and the ventilator’s compliance-compensation algorithm.)

alarm OFF to

160

6.5.18 HIGH INSPIRED TIDAL VOLUME Alarm

The high inspired tidal volume alarm indicates the patient’s inspired volume exceeds the set limit. When this condition occurs, the breath terminates and the alarm sounds. The ventilator displays monitored inspired tidal volume values in the patient data area on the GUI screen. When ventilation type is NIV, there is no high inspired tidal volume alarm or setting available, but the monitored inspired tidal volume (V data area on the GUI screen.

) may appear in the patient

6.5.19 HIGH RESPIRATORY RATE Alarm

The ↑ f

TOT

alarm indicates the measured breath rate is greater than or equal to the ⤒ f alarm is updated whenever a new total measured respiratory rate is available. The ↑ f

TOT

alarm setting. The ↑ f

TOT

alarm can detect tachypnea, which could indicate the tidal volume is too low or the patient’s work of breathing has increased. The ventilator phases in changes to the ⤒ f

TOT condition.

limit immediately to ensure prompt notification of a high respiratory rate

6.5.20 INSPIRATION TOO LONG Alarm

The INSPIRATION TOO LONG alarm, active only when ventilation type is Invasive, indicates the inspiratory time of a spontaneous breath exceeds the following time limit:

(1.99+0.02 × PBW) seconds (adult and pediatric circuits)

(1.00+0.10 × PBW) seconds (neonatal circuits) where PBW is the current setting for predicted body weight in kg.

When the ventilator declares an INSPIRATION TOO LONG alarm, the ventilator terminates inspiration and transitions to exhalation. The INSPIRATION TOO LONG alarm applies only to spontaneous breaths and cannot be set or disabled.

Because leaks (in the patient circuit, around the endotracheal tube cuff, or through chest tubes) and patient-ventilator mismatch can affect accurate exhalation detection, the INSPIRATION TOO LONG alarm can act as a backup method of safely terminating inspiration. If the INSPIRATION TOO LONG alarm occurs frequently, check for leaks and ensure E

SENS

and rise time% are properly set.

6.5.21 LOW CIRCUIT PRESSURE Alarm

Warning: Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall below

PEEP +3 cmH

O, attempting to set the ⤓ P

PEAK

alarm limit at or below this level will turn the alarm off.

The ↓ P

PEAK

alarm indicates the measured maximum airway pressure during the current breath is less than or equal to the set alarm level during a non-invasive inspiration or during a VC+ inspiration.

The ↓ P

PEAK

alarm is active for mandatory and spontaneous breaths, and is present only when ventilation type is

NIV or mandatory type is VC+. During VC+, the ↓ P turned OFF during NIV. The limit.

⤓ P

PEAK

alarm can be turned OFF. The ↓ P

PEAK

alarm can always be

alarm limit cannot be set to a value greater than or equal to the ⤒ P

PEAK

alarm

In VC+, whenever PEEP is changed, ↓ P

PEAK

≥16 cmH

O, or PEEP +3.5 cmH

is set automatically to its New Patient value, PEEP +4 cmH

O when PEEP <16 cmH

O when PEEP

There are no alarms dependent upon ↓ P

PEAK

, and the ↓ P

PEAK

alarm does not depend on other alarms.

6.5.22 LOW DELIVERED O

% Alarm

The ↓ O

% alarm indicates the measured O

2 below the O

2 sets the ↓ O

% during any phase of a breath is at or below the error percentage

% setting, or less than or equal to 18%, for at least 30 seconds. Although the ventilator automatically

% alarm, replace (if necessary) or disable the oxygen sensor to avoid nuisance alarms. The error

161

percentage is 12% below setting for the first hour of ventilator operation following a reset, 7% below setting after the first hour of operation, and an additional 5% below setting for the first 4 minutes following an increase in the setting.

The ventilator automatically adjusts the ↓ O disconnect, or a NO O

The ventilator checks the ↓ O

% alarm limit when O

/AIR SUPPLY alarm. The ↓ O

% changes due to apnea ventilation, circuit

% alarm is disabled during a safety valve open (SVO) condition.

% alarm against the measured oxygen percentage at 1-second intervals.

The ↓ O

% alarm can detect malfunctions in ventilator gas delivery or the oxygen monitor, and can ensure the patient is adequately oxygenated. The ventilator declares a alarms from transient O

% delivery variations. The O

↓ O

% alarm after 30 seconds to eliminate nuisance

% measured by the oxygen sensor is shown in the patient data area. See

Section 3.8.2.7, Vital Patient Data, page 81

to include O

% if it is not displayed.

6.5.23 LOW EXHALED MANDATORY TIDAL VOLUME Alarm

The alarm indicates the measured exhaled mandatory tidal volume is less than or equal to the ↓ V

TE MAND setting. The ↓ V

TE MAND

alarm

alarm updates when a new measured value of exhaled mandatory tidal volume is available.

The ↓ V

TE MAND

alarm can detect an obstruction, a leak during volume ventilation, or a change in compliance or resistance during pressure-based ventilation (that is, when the same pressure is achieved but tidal volume decreases). There are separate alarms for mandatory and spontaneous exhaled tidal volumes for use during SIMV,

SPONT, and BiLevel. The ventilator phases in a change to the ↓ V notification of a low exhaled tidal volume condition.

TE MAND

alarm immediately to ensure prompt

6.5.24 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm

The ↓

SPONT

TE SPONT available.

alarm indicates the measured exhaled spontaneous tidal volume is less than or equal to the ↓ V

alarm setting. The alarm updates when a new measured value of exhaled spontaneous tidal volume is

The ↓ V

TE SPONT

alarm can detect a leak in the patient circuit or a change in the patient’s respiratory drive during a single breath. The ↓ V

TE SPONT

alarm is based on the current breath rather than on an average to detect changes as quickly as possible. There are separate alarms for mandatory and spontaneous exhaled tidal volumes for use during SIMV and BiLevel. The ventilator phases in a change to the ⤓ V prompt notification of a low exhaled tidal volume condition.

TE SPONT

alarm limit immediately to ensure

6.5.25 LOW EXHALED TOTAL MINUTE VOLUME Alarm

The ↓ ⩒ or equal to the ↓ ⩒ volume.

E TOT

alarm indicates the measured minute volume (for mandatory and spontaneous breaths) is less than

E TOT

alarm setting. The ↓ ⩒

E TOT

alarm updates with each new calculation for exhaled minute

The ↓ ⩒

E TOT

alarm can detect a leak or obstruction in the patient circuit, a change in compliance or resistance, or a change in the patient’s breathing pattern. The ↓ ⩒

E TOT

alarm can also detect too-small tidal volumes, which could lead to hypoventilation and hypoxia (oxygen desaturation).

The ventilator phases in changes to the ↓ ⩒

E TOT prolonged low tidal volumes.

alarm limit immediately to ensure prompt notification of

6.5.26 PROCEDURE ERROR Alarm

The ventilator declares a PROCEDURE ERROR alarm if it is powered up (either by turning on the power switch or if power is regained following a power loss of at least 5 minutes) and the ventilator detects a patient attached before ventilator startup is complete. Until confirmation of the ventilator settings, the ventilator annunciates a

high-priority alarm and enters Safety PCV. See Table 54, page 239

162

The PROCEDURE ERROR alarm requires confirmation of ventilator settings after restoration of ventilator power, in case a new patient is attached to the ventilator. Safety PCV is an emergency mode of ventilation providing ventilation according to displayed settings until settings confirmation, and is not intended for long-term patient ventilation.

6.5.27 SEVERE OCCLUSION Alarm

A severe occlusion alarm occurs when gas flow in the ventilator breathing system is severely restricted. The ventilator enters occlusion status cycling (OSC) where the ventilator periodically attempts to deliver a pressure-based breath while monitoring inspiration and exhalation breath phases for a severe occlusion. If an occlusion is not detected, the ventilator considers the occlusion condition reset, clears the occlusion alarm, and continues ventilation with the settings in use before the occlusion occurred. The ventilator indicates an occlusion was detected.

6.6 Monitored Patient Data

Monitored patient data appear in the Patient Data Banner at the top of the GUI screen above the waveforms

display. See Figure 32, page 94

. Where applicable, factory defaults are indicated.

See

Section 3.8.2.7, Vital Patient Data, page 81

to change the displayed patient data parameters or the order in which they are displayed.

If any patient data values are displayed continuously blinking, it means their values are shown clipped to what has been defined as their absolute limits. If the values are displayed in parentheses “()”, it means they are clipped to their variable limits. Variable limits are based on various patient and ventilator settings. Each of these data points should be viewed as suspect.

Dashes (--) are displayed if the patient data value is not applicable based on mode/breath type combinations.

Note: A blinking patient data value means that the displayed value is greater-than or less-than either of its absolute limits and has been “clipped” to its limit. A data value that appears in parentheses means it has questionable accuracy. If no value is displayed, then the ventilator is in a state where the value cannot be measured.

The following sections contain descriptions of all patient data parameters shown in the patient data displays.

Note: All displayed patient volume data represent lung volumes expressed under BTPS conditions.

6.6.1 Total Exhaled Minute Volume

Total exhaled minute volume ( ⩒

E TOT

) is the BTPS and compliance compensated sum of exhaled gas volumes from both mandatory and spontaneous breaths for the previous 1-minute interval.

6.6.2 Exhaled Spontaneous Minute Volume

Exhaled spontaneous minute volume ( ⩒

E SPONT spontaneous volumes for the previous minute.

) is the BTPS- and compliance-compensated sum of exhaled

6.6.3 Exhaled Tidal Volume

Exhaled tidal volume (V

TE breath. Displayed V

) is the volume of the patient’s exhaled gas for the previous mandatory or spontaneous

is both compliance-and BTPS compensated, and updates at the next inspiration.

6.6.4 Proximal Exhaled Minute Volume

Proximal exhaled minute volume ( ⩒

E TOTY

) is the BTPS- and compliance-compensated sum of exhaled spontaneous volumes for the previous minute.

163

6.6.5 Proximal Exhaled Tidal Volume

Proximal exhaled tidal volume (V

TEY

) is the exhaled tidal volume for the previous breath measured by the Proximal

Flow Sensor (for neonatal patients, only). V

TEY

is updated at the beginning of the next inspiration.

6.6.6 Exhaled Spontaneous Tidal Volume

Exhaled spontaneous tidal volume (V

TE SPONT

) is the exhaled volume of the last spontaneous breath, updated at the beginning of the next inspiration following a spontaneous breath.

6.6.7 Exhaled Mandatory Tidal Volume

Exhaled mandatory tidal volume (V

TE MAND

) is the exhaled volume of the last mandatory breath, updated at the beginning of the next inspiration following a mandatory breath. If the mode is SPONT and the ventilator has not delivered mandatory breaths in a time period of greater than 2 minutes (for example via a manual inspiration), the

TE MAND

patient data indicator becomes hidden. The indicator reappears when the value updates.

6.6.8 Exhaled mL/kg Volume

The patient’s exhaled volume displayed in mL/kg PBW.

6.6.9 Inspired Tidal Volume

Inspired tidal volume (V pressure-based or NIV breaths, updated at the beginning of the following expiratory phase. V data are available.

) is the BTPS- and compliance-compensated volume of inspired gas for all

is displayed when

6.6.10 Proximal Inspired Tidal Volume

Proximal inspired tidal volume (V

TIY

) is the inspired tidal volume for a mandatory or spontaneous breath measured by the Proximal Flow Sensor (for neonatal patients, only). V expiratory phase and is displayed when data are available.

TIY

is updated at the beginning of the following

6.6.11 Delivered mL/kg Volume

The delivered gas volume in mL/kg PBW.

6.6.12 I:E Ratio

The ratio of inspiratory time to expiratory time for the previous breath, regardless of breath type. Updated at the beginning of the next inspiration. When I:E ratio is ≥ 1:1, it is displayed as XX:1. Otherwise it is displayed as 1:XX.

Note: Due to limitations in setting the I:E ratio in PC ventilation, the monitored data display may not exactly match the I:E ratio setting.

6.6.13 Mean Circuit Pressure

Mean circuit pressure (P or negative.

MEAN

) is the average circuit pressure for a complete breath period, including both inspiratory and expiratory phases whether mandatory or spontaneous. The displayed value can be either positive

6.6.14 Peak Circuit Pressure

Peak circuit pressure (P

PEAK

) is the maximum circuit pressure at the patient wye during the previous breath, including both inspiratory and expiratory phases.

6.6.15 End Inspiratory Pressure

End inspiratory pressure (P

I END

) is the pressure at the end of the inspiratory phase of the current breath.

164

6.6.16 End Expiratory Pressure

End expiratory pressure (PEEP) is the pressure at the end of the expiratory phase of the previous breath, updated at the beginning of the next inspiration. During an expiratory pause, the displayed value includes any active lung

PEEP.

6.6.17 Intrinsic PEEP

Intrinsic PEEP (PEEP

) is an estimate of the pressure above the PEEP level at the end of an exhalation. PEEP

is determined during an expiratory pause maneuver.

6.6.18 PAV-based Intrinsic PEEP

PAV-based intrinsic PEEP (PEEP

I PAV breath.

) is an estimate of intrinsic PEEP, updated at the end of a spontaneous PAV+™

6.6.19 Total PEEP

Total PEEP (PEEP

) is the estimated pressure at the circuit wye during the expiratory pause maneuver.

6.6.20 Plateau Pressure

Plateau pressure (P

) is the pressure measured and displayed during an inspiratory pause maneuver.

6.6.21 Driving Pressure (P

DRIVE

)

While ventilating with PAV+™, Driving Pressure (P

PEEP

TOT be calculated by dividing V

by C

PAV

DRIVE

and represents the amount of pressure required to overcome the elastic recoil of the lungs. P

PAV

) is the difference between Plateau pressure and estimated

DRIVE

can also

PAV+™ software automatically performs a 300 ms end-inspiratory hold in a random pattern every four to ten

PAV+™ breaths. Each time the end-inspiratory hold is conducted this pressure change is measured from the end expiratory lung pressure at the beginning of the breath to the pressure at the end of the plateau maneuver.

6.6.22 Total Respiratory Rate

Total respiratory rate (f

TOT patient.

) is the total number of mandatory and spontaneous breaths per minute delivered to the

6.6.23 PAV-based Lung Compliance

For a PAV+™ breath, PAV-based lung compliance (C each calculation. C

PAV

) is the change in pulmonary volume for an applied change in patient airway pressure, measured under zero-flow conditions and updated upon successful completion of

is displayed on the waveform screen.

6.6.24 PAV-based Patient Resistance

For a PAV+™ breath, PAV-based patient resistance (R in patient lung flow and updated upon successful completion of each calculation. R waveform screen.

PAV

) is the change in pulmonary pressure for an applied change

PAV

is displayed on the

6.6.25 PAV-based Lung Elastance

For a PAV+™ breath, PAV-based lung elastance (E

PAV completion of each calculation.

) is the inverse of C

PAV

and is updated upon successful

165

6.6.26 Spontaneous Rapid Shallow Breathing Index

Spontaneous rapid shallow breathing index (f/V indicate the inverse.

) is an indication of the patient’s ability to breathe spontaneously.

High values generally mean the patient is breathing rapidly, but with low tidal volumes. Low values generally

6.6.27 Spontaneous Inspiratory Time Ratio

In SPONT mode, spontaneous inspiratory time ratio (T

TOT

) is the percentage of a spontaneous breath consumed by the inspiratory phase. Updated at the successful completion of a spontaneous breath.

6.6.28 Spontaneous Inspiratory Time

Spontaneous inspiratory time (T

I SPONT

) is the duration of the inspiratory phase of a spontaneous breath and updated at the end of each spontaneous breath. T

I SPONT

is only calculated when the breathing mode allows spontaneous breaths and the breaths are patient-initiated.

6.6.29 PAV-based Total Airway Resistance

For a PAV+™ breath, PAV-based total airway resistance (R

TOT

) is the change in pulmonary pressure for an applied change in total airway flow and updated upon the successful completion of each calculation. If the R appears in parentheses as described at the beginning of this section, the R

TOT

PAV

value

value also appears in parentheses.

6.6.30 Static Compliance and Static Resistance

Static compliance (C

STAT

) is an estimate of the elasticity of the patient’s lungs, expressed in mL/cmH

O. It is computed during a mandatory breath.

Static resistance (R

STAT

) is the total inspiratory resistance across the artificial airway and respiratory system, displayed at the start of the next inspiration after the inspiratory pause maneuver. It is an estimate of how restrictive the patient’s airway is, based on the pressure drop at a given flow, expressed in cmH computed during a VC mandatory breath with a square flow waveform.

O/L/s. R

STAT

is calculated using this equation:

Figure 51.

Static Compliance (C

STAT

)

1 C

STAT

Static compliance

2 V pt

Total expiratory volume (patient and breathing circuit)

3 C ckt

Compliance of the breathing circuit during the pause maneuver (derived from SST)

4 P ckt

The pressure in the patient circuit measured at the end of the 100 ms interval defining the pause-mechanics plateau

5 PEEP The pressure in the patient circuit measured at the end of expiration

STAT

is calculated using this equation after C

STAT

is computed and assuming a VC breath type with a SQUARE waveform:

Figure 52.

Static Resistance (R

STAT

)

166

1 R

STAT

Static resistance

2 C ckt

Compliance of the breathing circuit during the pause maneuver (derived from SST)

3 ⩒ pt

Flow into the patient during the last 100 ms of the waveform

4 C

STAT

Static compliance

5 P

Mean pressure in the patient circuit over the 100 ms interval defining the pause-mechanics plateau

6 P

PEAK

Peak circuit pressure

During the pause, the most recently selected graphics are displayed and frozen, to determine when inspiratory pressure stabilizes. C and take this format:

STAT

and R

STAT

are displayed at the start of the next inspiration following the inspiratory pause

STAT xxx or

STAT

yyy

Special formatting is applied if the software determines variables in the equations or the resulting C

STAT values are out of bounds:

or R

STAT

• Parentheses ( ) signify questionable C

STAT

or R

STAT

values, derived from questionable variables.

• Flashing C

STAT

or R

STAT

values are out of bounds.

• R

STAT

------ means resistance could not be computed, because the breath was not of a mandatory, VC type with square flow waveform.

6.6.31 Dynamic Compliance

Dynamic compliance (C

DYN

) is a dynamic estimate of static compliance for each mandatory breath delivered.

6.6.32 Dynamic Resistance

Dynamic resistance (R

DYN

) is a dynamic estimate of static resistance for each mandatory breath delivered.

6.6.33 C

/C is the ratio of compliance of the last 20% of inspiration to the compliance of the entire inspiration.

6.6.34 End Expiratory Flow

End expiratory flow (EEF) is a measurement of the end expiratory flow for an applicable breath.

6.6.35 Peak Spontaneous Flow

Peak spontaneous flow (PSF) is a measurement of the maximum inspiratory spontaneous flow for an applicable spontaneous breath

6.6.36 Displayed O

Displayed O

% is the percentage of oxygen in the gas delivered to the patient, measured at the ventilator’s outlet, upstream of the inspiratory filter. It is intended to provide a check against the set O not as a measurement of oxygen delivered to the patient. O

% for alarm determination, and

% data can be displayed as long as the O

2 is enabled. If the monitor is disabled, dashes (--) are displayed. If a device alert occurs related to the O

2 a blinking 0 is displayed.

monitor

monitor,

6.6.37 Inspiratory Time Constant (3Tau

)

The 3Tau

parameter is three times the product of the patient’s resistance and compliance, and is used to determine the adequacy of the set inspiratory time (pressure ventilation), or the inspiratory time determined by the flow pattern, tidal volume, (V

), peak flow ( ⩒

MAX

), and plateau time (T

) settings (volume ventilation).

167

168

7 Preventive Maintenance

7.1 Overview

This chapter contains information on maintenance of the Puritan Bennett 980 Series Ventilator. It includes:

• How to perform routine preventive maintenance procedures, including frequency

• How to clean, disinfect, or sterilize the ventilator and its main components

• How to store the ventilator for extended periods

• How to dispose of used parts

7.2 Ventilator Operational Time

The ventilator contains an hour meter that records the number of operational hours since the ventilator was manufactured. An additional timer tracks the number of hours since the last preventive maintenance activity was performed. Both the GUI and the status display show the number of hours before the next preventive maintenance is due.

7.3 Preventive Maintenance Intervals

Warning: To ensure proper ventilator operation, perform preventive maintenance intervals as specified in the following tables. See

Table 39, page 169

and

Table 44

Table 39.

Operator Preventive Maintenance Frequency

Part

Patient circuit: inspiratory and expiratory limbs

Frequency

Several times a day or as required by the institution’s policy.

Condensate vial, water traps, and drain bag

Oxygen sensor calibration

Maintenance

• Check both limbs for water accumulation.

• Empty and clean.

Check and empty as needed.

Inlet air filter bowl

Reusable inspiratory filter • Before every use.

• After 15 days of continuous use in the inspiratory limb

(replace).

• Yearly or after 50 autoclave cycles (replace).

• Whenever excess resistance is suspected.

From the ventilator setup screen, touch the More Settings tab. To cal‐ ibrate the oxygen sensor, touch Cal‐ ibrate in the oxygen sensor area of the screen. See

Section 4.10.3, Oxygen

Sensor Calibration Testing, page 116 ,

for information on testing the oxy‐ gen sensor calibration.

• Replace bowl if it is cracked.

• If any sign of moisture is visible, remove ventilator from use and contact service personnel.

• Inspect and replace if cracked, crazed, or damaged. Sterilize between patients and circuit changes, or according to the institution’s policy. Sterilize before non-destructive dis‐ posal, or dispose of filter accord‐ ing to the institution’s policy.

169

Table 39.

Operator Preventive Maintenance Frequency (continued)

Reusable exhalation filter

Disposable inspiratory Filter

Disposable exhalation Filter

Battery

Exhalation flow sensor assembly

(EVQ)

Part

Compressor inlet air filter

Frequency

• Before every use.

• After 15 days of continuous use in the exhalation limb

(replace).

• Yearly or after 50 autoclave cycles (replace).

• Whenever excess resistance is suspected.

After 15 days of continuous use (dis‐ card).

When transferring battery to or from another ventilator.

Every 3 years, or as prompted.

Per institutional guidelines, or if SST flow sensor cross check fails. DO

NOT STERILIZE the exhalation flow sensor assembly.

Every 100 disinfection cycles. A dis‐ infection cycle is defined as one dis‐

infection event as described in Sec‐ tion 7.5.1, Exhalation Flow Sensor

Assembly (EVQ) Disinfection, page 174

Every 250 hours.

Maintenance

Run SST to check resistance of the inspiratory limb.

• Use care when changing inspir‐ atory filter to avoid filter damage and minimize the potential for introduction of particles.

• Run SST to check resistance of the expiratory limb and exhala‐ tion filter.

• Use care when changing exha‐ lation filter to avoid filter dam‐ age and minimize the potential for introduction of particles.

Discard according to the institution’s protocol.

Disinfect by wiping with a damp cloth using one of the solutions lis‐ ted. See

Table 40, page 172

, for approved cleaning agents.

Replace.

Disinfect. See Section 7.5, Component

Cleaning and Disinfection, page 172

and

Section 7.5.1, Exhalation Flow

Sensor Assembly (EVQ) Disinfection, page 174

Replace. Discard used flow sensor according to the institution’s proto‐ col. Run exhalation flow sensor cali‐ bration and SST.

Wash in mild soapy water and rinse thoroughly. Let air dry.

170

Table 39.

Operator Preventive Maintenance Frequency (continued)

Part

Neonatal door/adapter

Frequency

When gas pathway surfaces are visi‐ bly soiled or per institutional guide‐ lines.

When exterior surfaces of door are soiled.

Maintenance

Disinfect per

Table 41 .

Surface clean per

Section 7.4

Caution: Use specified cleaning, disinfection, and sterilization agents and procedures for the appropriate part as

instructed. Follow cleaning procedures outlined in Section 7.4, Surface Cleaning of Exterior Surfaces, page 171 .

7.4 Surface Cleaning of Exterior Surfaces

External surfaces of the GUI, BDU, and compressor base may become soiled and should be cleaned periodically.

To clean the GUI, BDU, or compressor base

1. Moisten a soft cloth with one of the disinfectants listed or use Sani Cloths (PDI™*.). See

Table 40 .

2. Wipe the GUI, BDU, and compressor base, removing any dirt or foreign substances.

3. Dry all components thoroughly.

4. If necessary, vacuum any cooling vents on the GUI and BDU with an electrostatic discharge (ESD)-safe vacuum to remove any dust.

171

Table 40.

Surface Cleaning Agents

Part

Ventilator exterior (including touch screen and flex arm)

Ventilator cooling vents

Procedure

Wipe clean with a cloth dampened with one of the cleaning agents lis‐ ted in

Table 40 or equivalent. Use a

damp cloth and water to rinse off chemical residue as necessary.

Mild dish washing detergent solu‐ tion

Isopropyl alcohol (70% solution)

Bleach (10% solution)

Window cleaning solution (iso‐ propyl alcohol and ammonia)

Ammonia (15% solution)

Hydrogen peroxide (3% solution)

Formula 409 pany)

® cleaner (Clorox Com‐

CaviCide ® surface disinfectant

(Metrex Research Corporation

Control III ® ucts, Inc.)

germicide (Maril Prod‐

Mr. Muscle Window & Glass (SC

Johnson

Sani Cloths (PDI, Inc.)

[Propan-2-ol, Isopropanol, Iso‐

propyl Alcohol] a

Vacuum the vents at the back of the

GUI and BDU to remove dust.

a Chemicals stated are the generic equivalents of Mr. Muscle Window & Glass

Comments/Cautions

Do not allow liquid or sprays to pen‐ etrate the ventilator openings or cable connections.

Do not attempt to sterilize the ven‐ tilator by exposure to ethylene oxide

(ETO) gas.

Do not use pressurized air to clean or dry the ventilator, including the GUI cooling vents.

Do not submerge the ventilator or pour cleaning solutions over or into the ventilator.

N/A

7.5 Component Cleaning and Disinfection

Warning: To avoid microbial contamination and potential performance problems, do not clean, disinfect, or reuse single-patient use (SPU) or disposable components. Discard per local or institutional regulations.

Risks associated with reuse of single-patient use items include but are not limited to microbial cross-contamination, leaks, loss of part integrity, and increased pressure drop. When cleaning reusable components, do not use hard brushes or implements that could damage surfaces.

Table 41.

Component Cleaning Agents and Disinfection Procedures

EVQ

Part Cleaning agents and procedure

Before disinfection, pre-soak in

EMpower Dual Enzymatic Solution

(Metrex Inc.).

Perform high level disinfection using liquid chemical disinfectant using any of the following agents:

Comments and cautions

Do not drop the EVQ or handle roughly during disinfection or storage.

172

Table 41.

Component Cleaning Agents and Disinfection Procedures (continued)

Part

Neonatal door/adapter

Reusable patient circuit tubing

Cleaning agents and procedure

• Cidex (2.5%)

• Metricide 28 (2.5%)

• Metricide OPA Plus (0.6%)

Sporox™*II (Sultan) Follow the man‐ ufacturer’s instructions

See Section 7.5.1, Exhalation Flow

Sensor Assembly (EVQ) Disinfection, page 174

for specific instructions.

Before disinfection, pre-soak in

EMpower Dual Enzymatic Solution

(Metrex Inc.).

Perform high level disinfection using liquid chemical disinfectant using any of the following agents:

• Cidex (2.5%)

• Metricide 28 (2.5%)

• Metricide OPA Plus (0.6%)

Follow the manufacturer’s instruc‐ tions.

Disinfect per manufacturer’s instructions-for-use.

N/A

Comments and cautions

Disposable patient circuit tubing

Breathing circuit in-line water traps Disinfect per manufacturer’s

Breathing circuit components

Disposable drain bag and tubing

(single unit)

Inlet air filter bowl

Discard instructions-for-use.

Disinfect per manufacturer’s instructions-for-use.

Discard when filled to capacity or when changing patient circuit.

Wash the bowl with mild soap sol‐ ution, if needed.

• Inspect for nicks and cuts, and replace if damaged.

• Run SST to check for leaks when reinstalling the circuit or when installing a new circuit.

Discard per the institution’s protocol.

• Inspect water traps for cracks and replace if damaged.

• Run SST to check for leaks when reinstalling the circuit or when installing new components.

• Inspect components for nicks and cuts, and replace if dam‐ aged.

• Run SST to check for leaks when reinstalling the circuit or when installing a new components.

N/A

Battery Wipe with a damp cloth using one of the cleaning agents listed. See

Table 40

• Avoid exposing the inlet air filter bowl to aromatic solvents, espe‐ cially ketones.

• Replace if cracks or crazing are visible.

Do not immerse the battery or get the contacts wet.

173

Table 41.

Component Cleaning Agents and Disinfection Procedures (continued)

Part

Cooling fan filter

Other accessories

Cleaning agents and procedure

Clean every 250 hours or as neces‐ sary. Wash in mild soap solution, rinse, and air dry.

Follow manufacturer’s instructionsfor-use.

N/A

Comments and cautions

To clean and disinfect parts

1. Wash parts in warm water using a mild soap solution.

2. Thoroughly rinse parts in clean, warm water (tap water is acceptable) and wipe dry.

3. Clean or disinfect parts per the procedures listed for each component. See Table 41, page 172 , for a list of

cleaning and disinfection agents.

4. After the components are cleaned or disinfected, inspect them for cracks or other damage.

5. Dispose of damaged parts according to the institution’s policy.

Note: Steps 1 through 3 above do not apply to the EVQ. See

Section 7.5.1, Exhalation Flow Sensor Assembly

(EVQ) Disinfection, page 174

, for disinfection instructions.

Whenever replacing or reinstalling a component, run SST before ventilating a patient.

7.5.1 Exhalation Flow Sensor Assembly (EVQ) Disinfection

Note: EVQ disinfection is not required on a routine basis but it should be disinfected if SST flow sensor cross check fails. See

Table 41, page 172

, for a list of appropriate disinfectants.

Note: Follow the institution’s infection control protocol for handling, storage, and disposal of potentially bio-contaminated waste.

Caution: To avoid damaging the hot film wire, do not insert fingers or objects into the center port when disinfecting the EVQ.

The EVQ contains the exhalation flow sensor electronics, exhalation valve diaphragm, exhalation filter seal, and pressure sensor filter. The exhalation flow sensor electronics consist of the hot film wire and the thermistor. Since it is protected by the exhalation filter, it does not require or need replacement or disinfection on a regular basis.

It is, however, removable and should be disinfected if SST flow sensor cross check fails. Expected service life is 100 disinfection cycles.

Caution: To avoid damage to the exhalation flow sensor element

• Do not touch the hot film wire or thermistor in the center port

• Do not vigorously agitate fluid through the center port while immersed.

• Do not forcefully blow compressed air or any fluid into the center cavity.

• Do not drop or handle roughly during disinfection or storage.

Warning: Damaging the flow sensor’s hot film wire or thermistor in the center port can cause the ventilator’s spirometry system to malfunction.

174

Figure 53.

EVQ

1 Top View

2 Bottom View

Figure 54.

EVQ Components

1 Hot film wire and thermistor

2 Diaphragm sealing surface

3 Electrical contacts

4 Filter grommet

7.5.1.1 Removal

Warning: Prior to cleaning and disinfection, remove and dispose of the disposable components of the exhalation flow sensor assembly.

To remove the EVQ

1. Lift up on the exhalation filter latch and open the exhalation filter door.

2. With thumb inserted into the plastic exhalation port and four fingers under the EVQ, pull it down until it snaps out. To avoid damaging the flow sensor element, do not insert fingers into the center port.

175

Figure 55.

EVQ Removal

To remove disposable components of the EVQ

1. Remove and discard the exhalation valve diaphragm, the exhalation valve filter seal, and the pressure sensor filter. Lift the exhalation filter seal out of the exhalation flow sensor to remove it.

Figure 56.

Exhalation Valve Diaphragm Removal

176

Figure 57.

Exhalation Filter Seal Removal

Figure 58.

Pressure Sensor Filter Removal

2. Dispose of the removed items according to the institution’s protocol. Follow local governing ordinances regarding disposal of potentially bio-contaminated waste.

7.5.1.2 Disinfection

Warning: Do not steam autoclave the EVQ or sterilize with ethylene oxide gas. Either process could cause the ventilator’s spirometry system to malfunction when reinstalled in the ventilator.

Warning:

Use only the disinfectants described. See Table 41, page 172 . Using disinfectants not recommended by

Covidien may damage the plastic enclosure or electronic sensor components, resulting in malfunction of the ventilator’s spirometry system.

Warning: Follow disinfectant manufacturer’s recommendations for personal protection (such as gloves, fume hood, etc.) to avoid potential injury.

177

1. Pre-soak the EVQ in the enzymatic solution. See

Table 39

. The purpose for this pre-soak is to break down any bio-film that may be present. Follow manufacturer’s instructions regarding duration of soak process.

Caution: Do not use any type of brush to scrub the EVQ, as damage to the flow sensing element could occur.

2. Rinse in clean, de-ionized water.

3. Prepare the chemical disinfectant according to the manufacturer’s instructions or as noted in the institution’s protocol. See

Table 41, page 172

, for the proper disinfecting agents.

4. Immerse in the disinfectant solution, oriented as shown, and rotate to remove trapped air bubbles in its cavities. Keep immersed for the minimum time period by the manufacturer or as noted in the institution’s protocol.

Figure 59.

Immersion Method

5. At the end of the disinfecting immersion period, remove and drain all disinfectant. Ensure all cavities are completely drained.

7.5.1.3 Rinsing

Warning: Rinse according to manufacturer’s instructions. Avoid skin contact with disinfecting agents to prevent possible injury.

1. Rinse the EVQ using clean, de-ionized water in the same manner used for the disinfection step.

2. Drain and repeat rinsing three times with clean, de-ionized water.

3. After rinsing in de-ionized water, immerse in a clean isopropyl alcohol bath for approximately 15 seconds.

Slowly agitate and rotate to empty air pockets.

7.5.1.4 Drying

• Dry in a low temperature warm air cabinet designed for this purpose. Covidien recommends a convective drying oven for this process, with temperature not exceeding 60°C (140°F).

178

Caution: Exercise care in placement and handling in a dryer to prevent damage to the assembly’s flow sensor element.

7.5.1.5 Inspection

See

Figure 54, page 175 , while inspecting the EVQ.

1. Inspect the plastic body, diaphragm sealing surface, filter grommet and the seal groove on the bottom side for any visible damage, degradation, or contamination.

2. Inspect electrical contacts for contaminating film or material. Wipe clean with a soft cloth if necessary.

3. Inspect the hot film wire and thermistor in the center port for damage and for contamination. DO NOT

ATTEMPT TO CLEAN EITHER OF THESE . If contamination exists, rinse again with de-ionized water. If rinsing is unsuccessful or hot film wire or thermistor is damaged, replace the EVQ.

7.5.2 EVQ Reassembly

The following illustration shows the reprocessing kit:

Figure 60.

EVQ Reprocessing Kit

1 Diaphragm

2 Pressure sensor filter

3 Exhalation filter seal

To reassemble the EVQ components

1. After drying the EVQ, remove the pressure sensor filter from the reprocessing kit and install its large diameter into the filter grommet with a twisting motion until flush with the plastic valve body, as shown. The narrow end faces out.

179

Figure 61.

Installing the Pressure Sensor Filter

Figure 62.

Installing the Pressure Sensor Filter

2. Remove the exhalation filter seal from the kit and turn the assembly so its bottom is facing up.

3. Install the seal into the exhalation flow sensor as shown in Figure 63

. Ensure that the seal fits completely within the recess and sits flat.

180

Figure 63.

Installing the Exhalation Filter Seal

1 Exhalation filter seal

4. Remove the diaphragm from the kit and install it. See Figure 64 .

Figure 64.

Installing the Diaphragm

181

Figure 65.

Installing the Diaphragm

1 Diaphragm bead located in the EVQ’s groove.

5. Carefully inspect component placement and the complete assembly.

7.5.3 EVQ Replacement

1. Replace the EVQ any time if cracked or damaged in use, or if a malfunction occurs during SST or EST.

2. Replace assembly if damage is noted to the hot film wire and thermistor in the center port.

3. Perform required calibrations. See

Table 39 .

To install the EVQ into the ventilator

1. With the exhalation filter door open, insert the assembly directly under the exhalation valve and push

straight up until it snaps into place. See Figure 66, page 183

. To avoid damaging the hot film wire, do not insert fingers into any opening.

2. Install the exhalation filter by sliding it onto the tracks in the door, and orienting the filter’s from patient port through the hole in the door.

3. Close exhalation filter door and lower exhalation filter latch.

182

Figure 66.

Installing the EVQ

4. Calibrate the flow sensor.

7.5.4 Storage

1. Pre-test the EVQ before storage by installing it into the ventilator and running SST to test the integrity of the

breathing system. See Section 3.9.1.2, SST Test Sequence, page 85

2. After performing SST, remove the assembly and place it into a protective bag or similar covered container.

7.6 Component Sterilization

To sterilize parts

1. Sterilize per the component’s instructions-for use or the steam sterilization procedure described. See

Table 42, page 183

and

Table 43, page 184

2. After the components are sterilized, visually inspect them for cracks or other damage.

3. Dispose of damaged parts according to the institution’s policy.

Table 42.

Sterilization Parameters

Autoclave sterilization

Effective sterilization occurs by steam autoclaving at 132°C (270°F) for 15 minutes for gravity displacement cycles. Pre-vac sterilization of wrapped goods (132°C for 4 minutes) may also be used. Refer to pre-vac system manufacturer’s program parameters or follow the steam sterilizer manufacturer’s instructions.

1. Disassemble the component.

2. Clean the component, then steam autoclave*.

3. Wrap each component in muslin or equivalent paper for autoclaving.

4. Place the wrapped parts in the steam autoclave and sterilize.

5. Inspect the sterilized parts for damage, and discard if damaged.

6. Reassemble the component.

7. Install the component on the ventilator.

8. Run SST.

*If performing pre-vac sterilization, follow system manufacturer’s instructions for use (IFU).

183

Table 43.

Component Sterilization Procedures

Part

Reusable exhalation and inspiratory filters

Exhalation filter condensate vial

Procedure

Steam autoclave per manufactur‐ er’s instructions-for-use

Comments/Cautions

• Do not chemically disinfect or expose to ETO gas.

• Check filter resistance using ventilator SST or other means before reuse.

• Follow manufacturer’s recom‐ mendations for reuse.

• Inspect the condensate vial for cracks after processing.

• Replace condensate vial if dam‐ aged.

N/A Reusable drain bag tubing (short piece of tubing attached to drain bag) and clamp

Clean and autoclave the reusable tubing; clean the clamp. See

Table 40, page 172

, for approved cleaning agents.

Whenever replacing or reinstalling a component, run SST before ventilating a patient.

7.7 Service Personnel Preventive Maintenance

Covidien recommends only qualified service personnel perform preventive maintenance activities summarized

in Table 44

. Complete details are described in the Puritan Bennett 980 Series Ventilator Service Manual .

At ventilator startup, and in Service mode, the GUI and status display indicate when there are 500 hours or less before preventive maintenance is due.

Table 44.

Service Preventive Maintenance Frequency

Frequency

Every 12 months

When ventilator location changes by 1000 feet of altitude

Entire ventilator

Part Maintenance

• Run extended self test (EST).

Test alarm system. See

Sec‐ tion 6.5.5, Alarm Testing, page 140 .

Primary and extended batteries

• Run performance verification.

This includes running an elec‐ trical safety test and inspecting ventilator for mechanical dam‐ age and for label illegibility.

Perform battery test (as part of EST and perform stand-alone battery test in Service mode).

Atmospheric pressure transducer Perform atmospheric pressure transducer calibration.

184

Table 44.

Service Preventive Maintenance Frequency (continued)

Frequency

Every 10 000 operational hours

Part

Internal inspiratory filter

Every year or as needed

BDU 10K hour kit

Compressor 10K hour kit

Oxygen sensor

Maintenance

Replace. Do not attempt to auto‐ clave or reuse.

Install. See the Puritan Bennett

980 Series Ventilator Service

Manual for information on tests required after installation of 10K PM

Kit.

Install. See the Puritan Bennett

980 Series Ventilator Service

Manual for information on tests required after installation of 10K PM

Kit.

• Replace the oxygen sensor as needed.

Actual sensor life depends on oper‐ ating environment. Operation at higher temperature or O

% levels will result in shorter sensor life.

7.8 Safety Checks

A Covidien-trained service technician should perform extended self test (EST) on the ventilator after servicing it at the intervals specified in

Table 44

. See the Puritan Bennett 980 Series Ventilator Service Manual for details on performing EST.

7.9 Inspection and Calibration

Ventilator inspection and calibration should be performed by a Covidien-trained service technician at the intervals specified in

Table 44 .

7.10 Documentation

A Medtronic-trained service technician should manually enter the service date, time, and nature of repair or preventive maintenance performed into the log using a keyboard on the GUI.

To manually document a service or preventive maintenance activity

1. Enter Service mode.

2. Select the Logs tab.

3. Select the Service Log tab.

4. Select Add Entry, and using the buttons to the right of each line, complete the entry.

5. Touch Accept when complete.

7.11 Storage for Extended Periods

To store the ventilator

1. Clean the unit thoroughly.

2. Remove any batteries and accessories.

To return the ventilator to service

185

1. Replace batteries.

2. Recharge batteries prior to patient ventilation. If batteries are older than three (3) years, use new batteries.

3. Perform EST and SST prior to patient ventilation.

186

8 Troubleshooting

8.1 Overview

This chapter contains information regarding ventilator logs on the Puritan Bennett 980 Series Ventilator.

Warning: To avoid a potential electrical shock, do not attempt to correct any electrical problem with the ventilator while it is connected to AC power.

8.2 Problem Categories

For the Puritan Bennett 980 Series Ventilator Operator’s Manual , troubleshooting is limited to responding to ventilator alarms and reviewing various ventilator logs. For detailed alarm information, including how to respond to alarms, see

Chapter 6

to address individual alarms that may occur during ventilator use. Qualified service personnel who have attended the Medtronic training class for Puritan Bennett 980 Series Ventilators should consult the Puritan Bennett 980 Series Ventilator Service Manual for detailed repair information and ventilator diagnostic codes.

8.3 How to Obtain Ventilator Service

To obtain service for the ventilator, call Medtronic Customer Service at 1800 255 6774 and follow the prompts.

8.4 Used Part Disposal

Follow local governing ordinances and recycling plans regarding disposal or recycling of device components.

Discard all damaged parts removed from the ventilator during the maintenance procedures according to your institution’s protocol. Sterilize contaminated parts before non-destructive disposal.

8.5 Ventilator Logs

The ventilator uses various logs to store event information for later retrieval when managing a patient’s treatment. Some of the logs are accessible during ventilation and some logs are only available to

Medtronic personnel when the ventilator is in Service mode. The Puritan Bennett 980 Series Ven‐ tilator Service Manual gives more details regarding logs available to qualified service personnel technicians.

When New Patient is selected during ventilator setup, patient data, ventilator settings, and alarm logs are cleared, but this information is available for service personnel to review following New Patient selection when the ventilator is set up.

• Alarms Log — The alarm log records up to 1000 alarms that have occurred, whether they have been reset or autoreset, the priority level, and their analysis messages.

The alarm log is accessible during normal ventilation and in Service mode. A date- and time-stamped entry is made in the log whenever an alarm is detected, escalated, reset or auto-reset. An entry is also made when an audio paused interval begins, ends, or is canceled. If one or more alarms have occurred since the last time the alarm log was viewed, a triangular icon appears on the GUI indicating there are unread items. The alarm log is stored in non-volatile memory (NVRAM) and may be re-displayed after the ventilator’s power is cycled.

If the ventilator enters BUV for any reason, this is also entered into the alarm log. The alarm log is cleared by setting the ventilator up for a new patient.

• Settings Log — The settings log records changes to ventilator settings for retrospective analysis of ventilator-patient management. The time and date, old and new settings. and alarm resets are recorded. A

187

maximum of 500 settings changes can be stored in the log. The settings log is cleared when the ventilator is set up for a new patient. The settings log is accessible in normal ventilation mode and Service mode.

• Patient Data Log —This log records every minute (up to 4320 patient data entries) consisting of date and time of the entry, patient data name, and the patient data value during ventilator operation. It is cleared when the ventilator is set up for a new patient. Three tabs are contained in the patient data log:

– Vital Patient data —The log contains the same information that the clinician has configured in the patient data banner at the top of the GUI. If the patient data parameters in the banner are changed, these changes are reflected the next time the patient data log is viewed.

– Additional Patient Data – 1 —This log corresponds to the patient data parameters set on page 1 of the additional patient data banner. A total of 15 parameters are stored here, consisting of date and time of the entry (recorded every minute), patient data name, and the patient data value during ventilator operation.

– Additional Patient Data – 2 —This log corresponds to the patient data parameters set on page 2 of the additional patient data banner. A total of ten parameters are stored here, consisting of date and time of the entry (recorded every minute), patient data name, and the patient data value during ventilator operation.

• Diagnostic Log — The Diagnostic Log is accessible during normal ventilation and Service modes and contains tabs for the System Diagnostic Log (default), the System Communication Log, and the EST/SST

Diagnostic Log. The diagnostic log contains tabs for the following logs:

– System Diagnostic Log — The System Diagnostic Log contains the date and time when an event occurred, the type of event, the diagnostic code(s) associated with each fault or error that occurred, the type of error that occurred, and any notes. See the Puritan Bennett 980 Series Ventilator Service Manual

(10078090) for specific information contained in the System Diagnostic Log. The diagnostic log is not cleared when the ventilator is set up for a new patient.

– System Communication Log — This log contains information generated by the ventilator’s communication software. See the Puritan Bennett 980 Series Ventilator Service Manual (10078090) for specific information contained in the System Communication Log.

– EST/SST Diagnostic Log — The EST/SST diagnostic log displays the time, date, test/event, system code

(see the Puritan Bennett 980 Series Ventilator Service Manual), type, and notes.

• EST/SST status log — The EST and SST status log displays the time, date, test/event, test status (passed or failed).

• General Event log — The general event log contains ventilator-related information not found in any other logs. It includes date and time of compressor on and off, changes in alarm volume, when the ventilator entered and exited Stand-By, GUI key presses, respiratory mechanics maneuvers, O

2 connection, elevate O

2 is not cleared upon new patient setup.

calibration, patient

, and warning notifications. The General event log can display up to 256 entries and

• Service Log — The service log is accessible during normal ventilation and Service modes and contains the nature and type of the service, reference numbers specific to the service event (for example, sensor and actuator ID numbers), manual and automatic serial number input, and the time and date when the service event occurred. It is not cleared upon new patient setup.

To view ventilator logs

1. Touch the clipboard icon in the constant access icon area of the GUI.

The log screen appears with tabs for the various logs.

2. Touch the tab of the log desired.

3. View the information for each parameter desired.

188

Figure 67.

Log Screen

1 Individual logs tabs

2 Pages contained in the log being viewed

Ventilator logs can be saved by entering Service mode, and downloading them via the ethernet port. See the

Puritan Bennett 980 Series Ventilator Service Manual for instructions on downloading ventilator logs.

8.6 Diagnostic Codes

Refer to the diagnostic log for the codes generated during patient ventilation. For more information on the diagnostic codes, contact Medtronic Technical Support.

189

190

9 Accessories

9.1 Overview

This chapter includes accessories that can be used with the Puritan Bennett 980 Series Ventilator. See

Table 45 , for

part numbers of any items available through Covidien.

The following commonly available accessories from the listed manufacturers can be used with the ventilator system:

• Filters — DAR/Covidien, Puritan Bennett

• Heated Humidification Systems — Hudson RCI/Teleflex™*, Fisher & Paykel

• Patient Circuits — commonly available breathing circuits with standard ISO 15 mm/ 22 mm connection for neonatal, pediatric, and adult patients. Manufacturers include Fisher & Paykel, DAR, and Hudson

RCI/Teleflex™*

• Masks — ResMed™*, Respironics™*, Fisher & Paykel

• Patient Monitoring Systems

— See Section 5.9, Connectivity to External Systems, page 133

, for information on which systems can be used with the ventilator

• Nasal Interfaces — Hudson RCI/Teleflex™*, Fisher & Paykel, Argyle

• Compressed air filter and water trap — Covidien

9.2 General Accessory Information

The patient circuit support arm (flex arm) can be fastened to the ventilator handle on either the right or left side.

Flex arms used on the Puritan Bennett™ 840 Ventilator System can also be used on the Puritan Bennett 980 Series

Ventilator System.

191

Figure 68.

Ventilator with Accessories

Figure 69.

Additional Accessories

See

Figure 68, page 192 and Figure 68

and

Figure 69

for the parts listed in Table 45

Note: Occasionally, part numbers change. If in doubt about a part number, contact your local Covidien representative.

Note: The ventilator is designed with a semi-automated short self test (SST) procedure that, in addition to other tests, measures compliance, resistance, and leak for the ventilator breathing circuit assembly (inspiratory filter, breathing circuit, humidifier chamber [as applicable], exhalation filter, and exhalation flow sensor). See

Section 3.9.1, SST (Short Self Test), page 84 . When SST is performed according to the instructions provided in

Section 3.9.1

, a ventilator breathing circuit assembly that passes SST for a particular patient type (adult, pediatric,

192

9 or neonatal) will allow the ventilator to operate within specification for that same patient type. Refer to

Table 59

for acceptable compliance and resistance ranges.

Table 45.

Accessories and Options

Item number

Accessory or option description

Test lung

Drain Bag Tubing (package of 10)

Drain Bag (package of 25)

Drain Bag Tubing Clamp, reusable (package of 5)

Pediatric-Adult exhalation Filter

Pediatric-Adult exhalation filtration system (carton of 12)

980 FRU, Exhalation flow sensor

Wall air water trap

Power cord, 10A, RA, UK

Power cord, 10A, RA, EU

Power cord, 10A, RA, Japan

Power cord, 10A, RA, British

Power cord, 10A, RA, Switzerland

Power cord, 10A, RA, USA

Power cord, 10A, RA, Israel

Power cord, 10A, RA, Brazil

Power cord, 10A, RA, China

Part number

10005490

4-048493-00

4-048491-00

4-048492-00

10063033

10043551

10097468

10086051

10087159

10087155

10087157

10087152

10087154

10081056

10087156

10087160

10087153

193

Table 45.

Accessories and Options (continued)

Item number

Accessory or option description

Air hose assembly; Norway, Sweden, Finland, Denmark, Greece,

France

Air hose assembly; Canada 4-074709-00

Air hose assembly; Italy, Switzerland, Spain, Belarus, Kazakhstan 4-074706-00

Air hose assembly; Japan, Israel

Air hose assembly; Poland, Portugal, South Africa

Air hose assembly; Switzerland

Air hose assembly; United States, Latin America

Air hose assembly; Germany, Luxembourg, Austria, Netherlands,

Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria, Roma‐ nia

Air hose assembly; United Kingdom, Ireland, Switzerland, Hungary,

Slovakia, Czech

Oxygen hose assembly; Norway, Sweden, Finland, Denmark,

Greece, France

Oxygen hose assembly; Canada

Oxygen hose assembly, Italy, Switzerland, Spain, Belarus, Kazakh‐ stan

Oxygen hose assembly; Japan, Israel

Oxygen hose assembly; Poland, Portugal, South Africa

Oxygen hose assembly; Switzerland

Oxygen hose assembly; United States, Latin America

Oxygen hose assembly; Germany, Luxembourg, Austria, Nether‐ lands, Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria,

Romania

Part number

4-074696-00

10001777

4-074703-00

4-074707-00

4-006541-00

4-074714-00

4-074713-00

4-074697-00

4-074710-00

4-074705-00

10001766

4-074705-00

4-074708-00

4-001474-00

4-074715-00

Oxygen hose assembly; United Kingdom, Ireland, Switzerland,

Hungary, Slovakia, Czech

4-074698-00

For countries not identified, contact your local Covidien representative for the proper air and oxygen hose part numbers.

Cylinder mount for compressed Air and O

gas

Flex arm assembly

FRU, caster base assembly

Rechargeable Lithium Ion battery

10086050

4-032006-00

980CASBAS

10086042

Humidifier bracket

Drain Bag Clip

Inspiratory bacteria filter, reusable (Re/Flex)

Inspiratory bacteria filter, disposable (carton of 50) (DAR)

Condensate vial, reusable

Condensate vial drain cap

10086049

10087137

4-074600-00

351U5856

10063031

4-074613-00

194

Table 45.

Accessories and Options (continued)

Item number

Not shown

Accessory or option description

Assy, patient circuit, adult dual heated wire, disposable, for F&P

MR850 (Medtronic / DAR) Adapter cable: 111/1149

Assy, patient circuit, single heated wire, adult, disposable, for F&P

MR850 (Medtronic / DAR) Adapter cable: 111/1146

Ventilator breathing circuit, adult, dual heated system, disposable

(Fisher & Paykel) b

Ventilator breathing circuit, adult, dual heated, no water traps, dis‐ posable (Hudson RCI / Teleflex™*)

Assy, patient circuit, with single water trap, heated insp. limb, pediatric, disposable for F&P MR850 (Medtronic / DAR) Adapter cable: 111/1146

Assy, patient circuit, dual heated wire, pediatric, disposable, F&P

MR850 (Intersurgical™*) b

Ventilator breathing circuit, pediatric, dual heated, disposable

(Hudson RCI / Teleflex™*)

Assy, patient circuit, neonatal, single heated wire, disposable, incu‐ bator use, for F&P MR850 (Medtronic / DAR) Adapter cable:

111/1146

Assy, patient circuit, neonatal, single heated wire, disposable, not for incubator use, for F&P MR850 (Medtronic / DAR) Adapter cable:

111/1146

Ventilator breathing circuit, neonatal, heated insp tube, disposable

(Hudson RCI / Teleflex™*)

Ventilator breathing circuit, neonatal, dual heated system, dispos‐ able, (Fisher & Paykel)

O-ring seal, condensate vial, reusable

Neonatal exhalation filtration system, disposable, with conden‐ sate vial

Proximal Flow monitoring sensor (disposable, 10/box)

Exhalation valve module reprocessing kit (6/ carton)

Gold standard test circuit, 21 inch (for performing EST)

End tidal CO

monitoring option

Integrated Nebulizer Upgrade Option

PB980 Exhaust Port Adapter

Hardware options

Proximal Flow monitoring option

980, USB flash drive

Software options

NeoMode 2.0 Software Upgrade

High Flow O

Therapy Upgrade Option

Part number

304S14300

304S14402Z

RT280

870-35 KIT

306S8987

5505850

780-24

307S9910

307/8682

780-06

RT265

10085527

4-076900-00

10047078

10086048

4-018506-00

10084332

980NEB

980EVQADAPT-30

10084331

PT00011076

10096526

980HFO2T

195

Table 45.

Accessories and Options (continued)

Item number

Not shown

Accessory or option description

IE Sync Trigger Upgrade Option

NIV plus Software Upgrade Option

Part number

980IESYNC

980NIVPLUS a Reusable filtration system does not include condensate vial. Reusable condensate vial must be ordered separately.

b The part numbers listed reflect the breathing circuit manufacturer part numbers and are subject to change. Refer to the breathing circuit manufacturer for exact circuit details regarding ordering information.

196

10 Theory of Operations

10.1 Overview

This chapter provides specific details on breath delivery functions of the Puritan Bennett 980 Series Ventilator. The chapter is organized as shown in the next table.

Section number

10.1

10.2

10.3

10.4

10.5

10.6

10.7

10.8

10.9

10.10

10.11

10.12

10.13

10.14

10.15

10.16

10.17

10.18

10.19

Title and Page

Section 10.1, Overview, page 197

Section 10.2, Theoretical Principles, page 198

Section 10.3, Applicable Technology, page 198

Section 10.4, Inspiration — Detection and Initiation, page 199

Section 10.5, Exhalation — Detection and Initiation, page 202

Section 10.6, Compliance and BTPS Compensation, page 203

Section 10.7, Mandatory Breath Delivery, page 206

Section 10.8, Spontaneous Breath Delivery, page 209

Section 10.9, A/C Mode, page 215

Section 10.10, SIMV Mode, page 216

Section 10.11, Spontaneous (SPONT) Mode, page 220

Section 10.12, Apnea Ventilation, page 220

Section 10.13, Detecting Occlusion and Disconnect, page 223

Section 10.14, Respiratory Mechanics, page 225

Section 6.4, Ventilator Settings, page 135

Section 10.16, Safety Net, page 238

Section 10.17, Power On Self Test (POST), page 241

Section 10.18, Short Self Test (SST), page 242

Section 10.19, Extended Self Test (EST), page 242

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

The gas supplies to which the ventilator are connected must be capable of delivering 200 L/min flow with the proper supply pressure between 241.8 kPa to 599.8 kPa (35 psig and 87 psig). These supplies may be compressed air from an external source (wall or bottled) air or oxygen. (An optional compressor is available to be used as an external air source.)

Air and oxygen hoses connect directly to the rear of the breath delivery unit (BDU). The flow of each gas is metered by a proportional solenoid (PSOL) valve to achieve the desired mix in the mix module. The flow through each PSOL is monitored by separate flow sensors to ensure the accuracy of the mix. The mixed gases then flow to the inspiratory module.

The blended gas in the inspiratory module is metered by the breath delivery PSOL and monitored by the breath delivery flow sensor to ensure that the gas is delivered to the patient according to the settings specified by the operator. Delivered tidal volumes are corrected to standard respiratory conditions (BTPS) to ensure consistent interpretation by the clinician. The inspiratory module also incorporates the safety valve, which opens to vent excess pressure and allows the patient to breathe room air (if able to do so) in the event of a serous malfunction.

197

An optional compressor, capable of delivering flows of 140 L/min (BTPS) and minute volumes of up to 40 L/min

(BTPS), can be connected to the ventilator. Gas mixing occurs in the accumulator, protected by a relief valve. A one-way valve allows a maximum reverse flow into the gas supply system up to 100 mL/min under normal conditions.

Air and O

gases travel through proportional solenoid valves (PSOLs), flow sensors, and one-way valves, and are mixed in the mix module (according to the operator-set O

concentration), which also has a pressure-relief valve.

From here, the gas flows through another PSOL, to the inspiratory pneumatic system, where it passes by a safety valve, then through a one-way valve, an internal bacteria filter, an external bacteria filter, through the humidifier, if used, and then to the patient via the connected breathing circuit.

During exhalation, the gas flows through the expiratory limb of the breathing circuit, through a condensate vial, a bacteria filter, through the exhalation flow sensor, through the exhalation valve, and out the exhaust port. The exhalation valve actively controls PEEP while minimizing pressure overshoots and relieving excess pressures.

Pressure transducers in the inspiratory pneumatic system (PI) and exhalation compartment (PE) monitor pressures for accurately controlling breath delivery.

10.2 Theoretical Principles

This theory of operations is described mainly from a clinical standpoint, discussing how the ventilator responds to various patient inputs, but also including a general description of the ventilator’s components and how they work together to manage breath delivery.

10.3 Applicable Technology

The ventilator’s control is provided by breath delivery (BD) and graphical user interface (GUI) central processing units (CPUs). The BD CPU manages all breath delivery functions and provides background checks on the subsystems required for breath delivery. The GUI CPU controls the primary display, operator input devices, and the alarm system. The status display, a small, non-interactive LCD display located on the breath delivery unit (BDU) is controlled by its own processor. See

Section 2.11.1.3, Status Display, page 43

for more information.

USB, Ethernet, and HDMI interfaces are provided on the ventilator. The USB interface supports items such as transferring data to an external monitor via a serial over USB protocol and saving screen captures to a memory

storage device or flash drive. See Section 5.4.3, Comm Port Configuration, page 121 for information on

serial-over-USB data transfer. The Ethernet interface is used by qualified service personnel for accessing ventilator logs and performing software options installation, and the HDMI interface provides the ability to display the GUI screen on an external video display device.

Pressure and flow sensors in the inspiratory and expiratory modules manage breath delivery processes. Sensor signals are used as feedback to the breath delivery PSOL and exhalation valve controllers. Additional flow and pressure sensors are used in the mix module to control the breathing gas composition. In addition, gas temperature is measured for temperature compensation of flow readings. Atmospheric pressure is measured in the inspiratory module and used for BTPS compensation. The sensor signals are filtered using anti-aliasing filters and sampled with A/D converters. Additional low-pass filters precondition the signals, the signals are then used for controls and display purposes.

Closed-loop control is used to maintain consistent pressure and flow waveforms in the face of changing patient and system conditions. This is accomplished by using the output as a feedback signal that is compared to the operator-set input. The difference between the two is used to drive the system toward the desired output. For example, pressure-control modes use airway pressure as the feedback signal to control gas flow from the ventilator. See the next figure. This diagram shows a schematic drawing of a general feedback control system. The input is a reference value (e.g., operator preset inspiratory pressure) that is compared to the actual output value

(e.g., instantaneous value of airway pressure). The difference between those two values is the error signal. The error signal is passed to the controller (e.g., the software control algorithm). The controller converts the error signal into a signal that can drive the actuator (e.g., the hardware drivers and valves) to cause a change in the manipulated variable (e.g., inspiratory flow).

198

Figure 70.

General Feedback Control System

Note: In the diagram shown, the “plant” is the patient and the connected breathing circuit.

10.4 Inspiration — Detection and Initiation

When ventilator inspiration occurs, it is called triggering. Breaths are delivered to the patient based on ventilator settings the practitioner has entered and are determined by pressure, flow, or time measurements, or operator action. The ventilator uses the following methods to trigger an inspiration:

• Pressure triggering (P-Trig)

• Flow triggering ( ⩒ -Trig)

• Time-triggered

• Operator-initiated

If the ventilator detects a drop in pressure at the circuit wye or when there is a decrease in base flow measured at the exhalation valve, the patient is said to trigger the breath. Mandatory breaths triggered by the patient are referred to as PIM or patient-initiated mandatory breaths.

All spontaneous breaths are patient-initiated, and are also triggered by a decrease in circuit pressure or measured base flow indicating the patient is initiating an inspiration.

Another term, autotriggering , is used to describe a condition where the ventilator triggers a breath in the absence of the patient’s breathing effort. Autotriggering can be caused by inappropriate ventilator sensitivity settings, water in the patient circuit, or gas leaks in the patient circuit.

10.4.1 Pressure Triggering

If pressure triggering (P-Trig) is selected, the ventilator transitions into inspiration when the pressure at the patient circuit wye drops below positive end expiratory pressure (PEEP) minus the operator-set sensitivity level (P

SENS

). See

Figure 71 . As the patient begins the inspiratory effort and breathes gas from the circuit (event 5, the A-B interval in

Figure 71 ), pressure decreases below PEEP. When the pressure drops below PEEP minus P

SENS

(event 6), the ventilator delivers a PIM breath. The pressure-decline time interval between events A and B determines how aggressive the patient’s inspiratory effort is. A short time interval signifies an aggressive breathing effort. The A-B interval is also affected by P

SENS probability of autotriggering.)

. A smaller P

SENS

setting means a shorter A-B time interval. (The minimum P setting is limited by autotriggering, and the triggering criteria include filtering algorithms that minimize the

SENS

199

Figure 71.

Inspiration Using Pressure Sensitivity

1 Exhalation

2 Inspiration

3 Event A: (patient inspires)

4 Event B: Patient-triggered inspiration begins

5 A-B interval

6 Operator-set pressure sensitivity

10.4.2 Flow Triggering

If flow triggering ( ⩒ -Trig) is selected the BDU provides a constant gas flow through the ventilator breathing circuit

(called base flow) during exhalation. The base flow is 1.5 L/m greater than the value selected for flow sensitivity

( ⩒

SENS

). See

Figure 72

inspiratory flow.]

, where the top graphic represents expiratory flow and the bottom graphic represents

The ventilator’s breath delivery flow sensor measures the base flow delivered to the circuit and the exhalation flow sensor measures the flow entering the exhalation valve. The ventilator monitors patient flow by measuring the difference between the inspiratory and exhaled flow measurements. If the patient is not inspiring, any difference in measured flows is due to leaks in the breathing system or flow sensor inaccuracy. The clinician can compensate for leaks in the breathing system by increasing ⩒

SENS

to a value equal to desired ⩒

SENS

+ leak flow.

As the patient begins the inspiratory effort and inspires from the base flow, less exhaled flow is measured, while the delivered flow remains constant. See

Figure 72 (event A). As the patient continues to inspire, the difference

between the delivery and exhalation flow sensor measurements increases. The ventilator initiates an inspiration when the difference between the two flow measurements is greater than or equal to the operator-set flow

sensitivity value. See Figure 72

(event B).

As with pressure triggering, the time delay between onset of the patient’s effort and actual gas delivery depends on:

• how quickly the exhaled flow declines (that is, the aggressiveness of the inspiratory effort). The more aggressive the inspiratory effort, the shorter the interval

• the flow sensitivity value. The smaller the value, the shorter the delay.

During flow triggering, a backup pressure sensitivity of 2 cmH

2 that the flow trigger fails.

O is present to detect a breath trigger in the event

200

Figure 72.

Inspiration Using Flow Sensitivity

1 Software-set base flow (L/min)

2 Start of patient effort

3 Event A: flow is decreasing

4 Event B: gas delivery begins

5 Operator-set flow sensitivity

6 1.5 L/min

7 Flow delivered to patient

10.4.3 Time Triggers

The ventilator measures the time interval for each breath and breath phase. If the ventilator is in Assist/Control

(A/C) mode (where the ventilator delivers breaths based on the breath rate setting), a VIM or ventilator initiated mandatory breath is delivered after the appropriate time interval. The duration of the breath in seconds ( T b

) is 60/f.

Figure 73.

Breath Activity During Time-triggered Inspiration

1 2 1

3 3

VEN_10759_B

1 Breath activity (VIM)

2 Breath activity (PIM)

3 Time period (Tb)–(60/f )

10.4.4 Operator-initiated Triggers

If the operator presses the manual inspiration key, an OIM (operator-initiated mandatory) breath is delivered. The ventilator will not deliver an OIM under the following conditions:

• During an active inspiration, whether mandatory or spontaneous

• During the restricted phase of exhalation

• During circuit disconnect and occlusion status cycling (OSC) conditions

See

Section 10.7.5, Manual Inspiration, page 209

later in this chapter for information on the restricted phase of exhalation.

201

10.5 Exhalation — Detection and Initiation

When exhalation occurs, it is called cycling. Mandatory breaths can be volume-cycled or time-cycled by the ventilator or pressure cycled by the patient. Spontaneous breaths can be flow-cycled or pressure-cycled by the patient or time-cycled by the ventilator. A patient-cycled exhalation relies on measurements such as inspiratory flow rate or airway pressure. The ventilator uses the three methods listed to detect exhalation:

• Airway pressure method (spontaneous breaths)

• Percent peak flow method (spontaneous breaths)

• Time-cycling method (mandatory breaths)

10.5.1 Airway Pressure Method

If expiratory sensitivity (E

SENS

) is set to a value too low for the patient-ventilator combination, a forceful expiratory effort could cause circuit pressure (P

PEAK

) to rise to its limit. The ventilator monitors circuit pressure throughout the inspiratory phase, and initiates an exhalation when the pressure equals the inspiratory pressure (P

I volume support (VS).

) target value + an incremental value. This transition to exhalation occurs during spontaneous pressure-based ventilation and in

Note: The allowable incremental value above the target pressure is 1.5 cmH

O once a portion of inspiration time

( Tn ) has elapsed. Before Tn , the incremental value is higher to allow for transient pressure overshoots. For the first

200 ms of inspiration, the incremental pressure is 10% of the target pressure, up or 8 cmH

O, whichever is greater.

From 200 ms to Tn , the incremental pressure decreases in a linear fashion from the initial value to 1.5 cmH

Figure 74.

Exhalation via the Airway Pressure Method

1 Pressure target

2 Pressure target +incremental value (n)

3 Start breath

4 200 ms

5 Tn

10.5.2 Percent Peak Flow Method

For spontaneous breath types including PS (pressure supported), TC (tube compensated), and VS (volume supported), the ventilator captures the value of the delivered peak inspiratory flow, then monitors the inspiratory flow decline until the ratio of current flow to peak flow (expressed as a percentage) is less than or equal to the set

SENS

value. The ventilator then cycles from inspiration into exhalation.

See

Figure 75

for an example of exhalation using the percent peak flow method.

202

Figure 75.

Typical flow-cycled breath

1 Flow (y-axis)

2 Peak flow

3 E

SENS

=a % of peak flow

4 Inspiration

5 Exhalation

6 Time (x-axis)

Note: PAV+™ uses a flow-based cycling method, also called E

SENS

⩒

MAX

but it is expressed in L/min rather than in % of

10.5.3 Time-cycling Method

In pressure ventilation, the set inspiratory time (T ventilation, T

depends on the tidal volume (V

) defines the duration of the inspiratory phase. In volume

) setting, peak flow ( ⩒

MAX

), flow pattern, and plateau time (T

). The ventilator cycles into exhalation when the set T

(pressure ventilation) or computed T

(volume ventilation) lapses.

10.5.4 Backup Methods

There are four backup methods for preventing excessive duration or pressure during inspiration

• Time limit — For adult and pediatric patients, the time limit method ends inspiration and begins exhalation when the duration of a spontaneous inspiration is greater than or equal to [1.99 s+ 0.02 × PBW (kg)] seconds.

• High circuit pressure limit — During any type of inspiration, inspiration ends and exhalation begins when the monitored airway pressure (P

CIRC

) is greater than or equal to the set high circuit pressure limit.

• High ventilator pressure limit — The ventilator transitions from inspiration to exhalation if the high ventilator pressure ( ⤒ P

VENT

) limit of 110 cmH

O is reached.

• High inspired tidal volume limit — The high inspired tidal volume limit terminates inspiration and commences exhalation during VC+, VS, tube compensated (TC), or proportionally assisted (PAV+™) breaths if the delivered volume is greater than or equal to ⤒ V

Note: The ventilator does not generate subatmospheric airway pressures during exhalation.

10.6 Compliance and BTPS Compensation

10.6.1 Compliance Compensation in Volume-based Breaths

Compliance compensation accounts for the gas volume not actually delivered to the patient during inspiration.

This gas is known as the compliance volume, VC. VC is the gas lost to pressurizing the breathing circuit and includes the volumes of the patient circuit, any accessories such as a humidifier and water traps, and internal ventilator gas passages.

203

Figure 76.

Square Flow Pattern

1 Flow (y-axis)

2 Actual ⩒

MAX

3 Set ⩒

MAX

Figure 77.

Descending Ramp Flow Pattern

4 Compliance volume (VC)

5 Set V

6 T

1 Flow (y-axis)

2 Actual ⩒

MAX

3 Set ⩒

MAX

4 Compliance volume (VC)

5 Set V

6 T

7 Minimum ⩒

MAX

In the ventilator, an iterative algorithm automatically computes the compliance volume. There is a maximum tubing-to- patient compliance ratio to reduce the potential for over-inflation due to an erroneous patient compliance estimation. The maximum ratio is determined by the selected patient circuit type and predicted body weight (PBW):

204

Factor Compliance volume factor

C pt ckt

Compliance of the patient circuit

The compliance volume is calculated as

C pt

Compliance of the patient

C pt ckt

Compliance volume

Compliance of the patient circuit

P wye

Pressure at the patient wye at the end of the current inspiration

Pressure at the end of the current exhalation

Without automated compliance compensation, practitioners would have to compute volume in the patient circuit, then increase the V

C increment to compensate for compliance volume provides only partial compensation, and requires extra effort and understanding by the practitioner. Additionally, P wye

and P can change with time.

to estimate the loss of

setting by that amount. Increasing the tidal volume by a single

An iterative algorithm in the ventilator automatically computes the compliance volume and compensates for it.

Compliance compensation does not change inspiratory time (T amplitude of the selected flow pattern). Keeping T

). It is achieved by increasing flow (increasing the

constant maintains the original I:E ratio.

There is a maximum compliance volume to reduce the potential for overinflation due to an erroneous compliance volume calculation. The maximum compliance volume is determined by the selected patient circuit type and predicted body weight (PBW), and is summarized by this equation:

V comp,max

= Factor x Tidal volume where:

V comp,max

= maximum compliance volume

Factor = linear interpolation of the values in Table 46

for adult, pediatric, and neonatal circuit types. Factor is calculated as:

MIN (10, MAX (2.5, 1.0+(2.0/0.3× kg PBW)))

Table 46.

Compliance Volume Factors

Adult patient circuit type

PBW (kg) Factor

≤10 5

4.6

3.4

≥150

2.75

2.5

Pediatric patient circuit type

PBW (kg) Factor

≤10 5

12.5

3.5

2.9

2.7

2.5

Neonatal patient circuit type

PBW (kg) Factor

≤0.7

≥4.5

7.67

4.33

3.22

2.5

Note: Compliance compensation calculations are also in effect during exhalation to ensure spirometry accuracy.

If the patient’s compliance decreases beyond the limits of compliance compensation, the ventilator relies on the

⤒ P

PEAK

alarm setting to truncate the breath and switch to exhalation.

205

10.6.2 BTPS Compensation in Volume-based Breaths

Volumes and flows are BTPS compensated, that is, they are reported by the ventilator at existing barometric pressure, 37°C (98.6°F), and fully saturated with water vapor.

10.7 Mandatory Breath Delivery

Three mandatory breath types are offered in the ventilator — volume control (VC) which bases breath delivery on the delivered inspiratory tidal volume, pressure control (PC), which bases breath delivery on achieving and sustaining a pressure target for a set period of time, and volume control plus (VC+) which is a pressure-controlled breath based on a target tidal volume. VC+ can be used in situations where a patient’s lungs become more compliant due to treatment as it reduces the target pressure (lessening the forces on the alveoli) to achieve the target tidal volume.

Mandatory breaths are delivered by the ventilator, are either assisted (if patient initiated or PIM), or controlled (if ventilator initiated or VIM), or initiated by the operator (OIM). In A/C mode, the breath period ( T using the breath rate (f ) according to the equation b

) is calculated

If, during T b

, patient effort is detected, a PIM breath is initiated and a new breath period starts. If no patient effort is detected before T b

lapses, the next breath delivered is a VIM, and a new breath period starts.

See

Table 64 for details on the following VC+ settings:

• Expiratory time (T

• I:E ratio

)

• Inspiratory time (T

)

• Rise time%

• Target or tidal volume (V

)

VC and PC breath types require no initialization. A VC breath is based on meeting a delivered volume target and a PC breath is based on meeting a specific pressure target. VC+ breaths, however, go through a startup routine.

10.7.1 Volume Control (VC)

Volume Control is the control scheme that controls the flow with for the purpose of supplying a predetermined volume (set by the practitioner) to the patient. There are two basic flow wave forms to administer this volume: the

“square” that guarantees a constant flow during the inspiration time, or the “descending ramp” whose slope and

initial value are determined to provide the required volume target. See Figure 78 and Figure 79

. The inspiration time is determined indirectly by the characteristics of the selected flow wave.

206

Figure 78.

Ideal Waveform Using Square Flow Pattern

1 Pressure (cmH

2 Flow (L/min)

3 Volume (mL)

4 Inspiratory phase

5 Expiratory phase

6 Constant flow

Figure 79.

Ideal Waveform Using Descending Ramp Flow Pattern

1 Pressure (cmH

2 Flow (L/min)

3 Volume (mL)

207

4 Inspiratory phase

5 Expiratory phase

6 Descending ramp

10.7.2 Pressure Control (PC)

Pressure Control is the control scheme by which the pressure is controlled at the circuit wye to reach a constant

level (set by the practitioner) during inspiration, and a PEEP level during exhalation. See Figure 80, page 208 . This

level is maintained for a time given by the set inspiration time, followed by an exhalation regulated by the exhalation valve until the PEEP level is reached. As flow is not predetermined, the supplied volume varies depending on the patient’s pulmonary response.

Figure 80.

Ideal Waveform Using Pressure Control Ventilation

1 Pressure (cmH

2 Flow (L/min)

3 Volume (mL)

4 Target pressure

5 PEEP

6 Inspiratory phase

7 Expiratory phase

10.7.3 VC+

VC+ breaths require initialization and must go through a startup routine.

10.7.3.1 VC+ Startup

Up to three test breaths are delivered prior to ventilating the patient with VC+ breaths. The delivered VC+ test breaths are volume control (VC) breaths (if Leak Sync is disabled) using the VC+ settings for V

and inspiratory time and a ramp flow pattern. Delivered peak flows are calculated based on SST tubing compliance, assuming an end-inspiratory pressure of 15 cmH

O above PEEP for adult and pediatric patient types, and 10 cmH

O above PEEP for neonatal patient type. After each test breath, the measured delivered volume and the end-inspiratory pressure and end expiratory pressure are used to estimate the patient’s lung compliance to determine the VC+ pressure target to achieve the set V a PC breath is delivered with P using the T

. In VC+, if pressure and volume measurements from the test breaths are not valid, then

of 15 cmH

and rise time% settings in VC+.

O for pediatric and adult patients or 10 cmH

O for neonatal patients

Note: To allow for optimal function of startup and operation of VC+ in the ventilator it is important not to block the tubing while the patient is undergoing suctioning or other treatment that requires disconnection from the ventilator. The ventilator has a disconnect detection algorithm that suspends ventilation while the patient is disconnected.

After VC+ Startup, the ventilator will make adjustments to the target pressure to deliver the set volume (V summarized in

Table 47 .

). To reach the desired volume promptly, the maximum allowed pressure adjustments for all patient circuit types are

208

Table 47.

Pressure Adjustment Limits According to Patient Body Weight (PBW)

Condition

Maximum pressure adjustment (up), cmH

Minimum pressure adjust‐ ment (down), cmH

-6

+4.5

-6

7 ≤ PBW <

15 kg

-6

15 ≤ PBW <

20 kg

-8

20 ≤ PBW kg

See

Table 37 for details on the following VC+ alarms:

• VOLUME NOT DELIVERED

• HIGH INSPIRED TIDAL VOLUME ( ↑ V

)

• LOW CIRCUIT PRESSURE ( ↓ P

PEAK

)

• COMPLIANCE LIMITED V

During VC+, inspiratory target pressure cannot be lower than PEEP +3 cmH

⤒ P

PEAK

–3 cmH

O and cannot exceed

+10

-10

10.7.4 Rise time%

If PC or VC+ is selected as the mandatory type, adjust rise time% for optimum flow delivery into lungs. Patients with high impedance (low compliance, and high resistance) may benefit from a lower rise time% whereas patients with low impedance may better tolerate a more aggressive rise time setting. The rise time% setting specifies the speed at which the inspiratory pressure reaches 95% of the target pressure. The rise time setting applies to PS (including a setting of 0 cmH

O), PC, or VC+ breaths. To match the flow demand of an actively breathing patient, observe simultaneous pressure-time and flow-time curves, and adjust the rise time% to maintain a smooth rise of pressure to the target value. A rise time% setting reaching the target value well before the end of inspiration can cause the ventilator to supply excess flow to the patient. Whether this oversupply is clinically beneficial must be evaluated for each patient. Generally, the optimum rise time% for gently breathing patients is less than or equal to the default

(50%), while optimum rise time% for more aggressively breathing patients can be 50% or higher.

Warning: Under certain clinical circumstances (such as stiff lungs, or a small patient with a weak inspiratory drive), a rise time% setting above 50% could cause a transient pressure overshoot and premature transition to exhalation, or pressure oscillations during inspiration. Carefully evaluate the patient’s condition before setting the rise time

% above the default setting of 50%.

10.7.5 Manual Inspiration

When pressed, the Manual Inspiration key delivers one OIM breath to the patient, using set breath delivery parameters.

The ventilator will not allow a manual inspiration during the restricted phase of exhalation or when the ventilator is in the process of delivering a breath whether mandatory or spontaneous). All manual inspiration attempts are logged in the General Event log.

The restricted phase of exhalation is the time period during the expiratory phase where an inspiration trigger is not allowed. The restricted phase of exhalation is defined as the first 200 of exhalation or the time it takes for expiratory flow to drop to ≤50% of the peak expiratory flow, or the time it takes for the expiratory flow to drop to

≤0.5 L/min (whichever is longest). The restricted phase of exhalation will end after 5 seconds of exhalation have elapsed regardless of the measured expiratory flow rate.

10.8 Spontaneous Breath Delivery

The modes allowing spontaneous breaths are SIMV, SPONT, and BiLevel.

209

The spontaneous breath type setting determines which type of pressure-assist will be applied to the patient’s spontaneous breaths (PS, TC, VS, or PAV+™).

After selecting the spontaneous breath type, choose the level of pressure support (P

T SUPP

) for VS or percent support for TC and PAV+™ and specify the rise time% and E

SENS

) for PS, Support volume

, where available. Changes to the spontaneous breath type setting phase in at the start the next inspiration.

SUPP

Note: In any delivered spontaneous breath, either Invasive or NIV, there is always a target inspiratory pressure of at least 1.5 cmH

O applied.

During spontaneous breathing, the patient’s respiratory control center rhythmically activates the inspiratory muscles. The support type setting allows selection of pressure-assist to supplement the patient’s pressure-generating capability.

Table 48.

Spontaneous Breath Delivery Characteristics

Characteristic

Inspiratory detection

Pressure or flow during inspiration

Spontaneous type = PS and P

SUPP

<5 cmH

Implementation

SENS or ⩒ SENS depending on the trigger type selected.

Pressure rises according to the selected rise time% and PBW setting, with target pressure equal to the effective pressure + PEEP:

SUPP

0 1.5

1 2.2

2 2.9

3 3.6

4 4.3

Effective pressure (cmH

Pressure or flow during inspiration

Spontaneous type = PS and P

SUPP

≥ 5 cmH

Pressure or flow during inspiration

Spontaneous type = VS

Pressure rises according to the selected rise time% and PBW setting, and target pressure equals P

SUPP

+ PEEP.

Pressure rises according to the selected rise time% and PBW setting, and target pressure equals the pressure determined during the test breath or pressure target determined from assessment of delivered volume from the previous breath. For more information on VS, see

Section 10.8.2, Volume Support (VS), page 211

Tube compensation (TC) Tube compensation provides programmable, inspiratory pressure assistance dur‐ ing otherwise unsupported spontaneous breaths. This assists the patient in over‐ coming the flow resistance of the artificial airway. Pressure is programmed to help the patient overcome part or all of the resistance of the artificial airway. The venti‐ lator continuously calculates the pressure differential and adjusts the compensa‐

tion pressure accordingly. For more information regarding TC, see Section 10.8.3,

Tube Compensation, page 212 .

Inspiratory flow profile The inspiratory flow profile is determined by patient demand and the rise time% setting. As the rise time% setting is increased from minimum to maximum, the time to achieve the pressure target decreases. The maximum available flow is up to

30 L/min for neonatal circuit types, 80 L/min for pediatric circuit types, and up to

200 L/min for adult circuit types without Leak Sync.

Adjusts to minimize pressure overshoot and maintain the target pressure.

Exhalation valve during inspiration

Inspiratory valve during inspiration

Adjust to maintain target pressure.

Because the exhalation valve acts as a relief valve venting any excess flow, inspir‐ atory flow can be delivered aggressively and allows reduced work of breathing.

Expiratory detection The end-inspiratory flow or airway pressure method, whichever detects exhalation first. Time backup and the ↑ P

PEAK

alarm are also available as backup strategies.

210

Table 48.

Spontaneous Breath Delivery Characteristics (continued)

Characteristic

Pressure or flow during exhalation

Inspiratory valves during exhalation

Exhalation valve during exhalation

Implementation

Pressure is controlled to PEEP.

For pressure triggering: set to deliver a bias flow of 1 L/min

For flow triggering: set to deliver base flow.

For pressure triggering: set to deliver a bias flow of 1 L/min near the end of expiratory flow.

For flow triggering: set to deliver base flow near the end of expiratory flow.

Adjusts to maintain the operator-selected value for PEEP.

10.8.1 Pressure Support (PS)

Pressure Support is a type of spontaneous breath, similar to PC, by which the pressure is controlled to reach a constant value, preset by the practitioner, once an inspiratory effort is detected. This target value is held until the detection of end of inspiration. Subsequently, the exhalation valve control initiates the exhalation, driving the pressure to the PEEP level.

10.8.2 Volume Support (VS)

Volume support is a pressure-supported spontaneous breath type available when SPONT is selected as the mode.

The target support volume (V

T SUPP

) is the target volume for pressure supported breaths.

See

Table 64 for details regarding the following VS settings:

• Expiratory sensitivity (E

SENS

)

• Rise time%

• Target support volume (V

T SUPP

)

10.8.2.1 Technical Description

Volume Support (VS) breaths are patient-triggered, pressure-supported spontaneous breaths. The VS algorithm varies the inspiratory pressure of each breath to deliver the operator-set target tidal volume (V

T SUPP

). If the delivered volume for a breath is above or below the set target volume, VS adjusts the target pressure for the next breath up or down, as necessary, to deliver more or less volume. As the patient’s condition improves allowing more patient control over spontaneous ventilation, the VS algorithm decreases the amount of inspiratory pressure necessary to deliver the target volume. Conversely, VS increases inspiratory pressure if the patient’s respiratory drive becomes compromised.

In the absence of leaks or changes in patient resistance or compliance, Volume Support achieves and maintains a steady, breath-to-breath tidal volume within five breaths of VS initiation or startup.

During VS, the inspiratory pressure target cannot be lower than PEEP +1.5 cmH

⤒ P

PEAK

–3 cmH

O, and cannot exceed

10.8.2.2 VS Startup

Test breaths are delivered prior to ventilating the patient with VS breaths. The delivered VS test breaths are pressure support breaths using a P

SUPP

value of 15 cmH

O for pediatric and adult patients or 10 cmH

O for neonatal patients. The test breaths use the E

SENS

and rise time% settings in VS. After each test breath, the measured delivered volume and the end-inspiratory pressure and end-expiratory pressure are used to estimate the patient’s lung compliance to determine the VS pressure target to achieve the set V volume measurements are valid.

. In VS, if pressure and volume measurements from test breaths are not valid, VS startup continues delivering test breaths until the pressure and

211

Note: To allow for optimal function of startup and operation of VS in the ventilator it is important not to block the tubing while the patient is undergoing suctioning or other treatment that requires disconnection from the ventilator. The ventilator has a disconnect detection algorithm that suspends ventilation while the patient is disconnected.

After VS Startup, the ventilator makes adjustments to the target pressure to deliver the set volume (V are summarized in

Table 47 .

T SUPP

). To reach the desired volume promptly, the maximum allowed pressure adjustments for all patient circuit types

Table 49.

Pressure Adjustment Limits According to Patient Body Weight (PBW)

Condition

Maximum pressure adjustment (up), cmH

Minimum pressure adjust‐ ment (down), cmH

-6

+4.5

-6

7 ≤ PBW <

15 kg

-6

15 ≤ PBW <

20 kg

-8

20 ≤ PBW kg

+10

-10

See

Table 38 for details on the following VS alarms:

• VOLUME NOT DELIVERED

• COMPLIANCE LIMITED V

• HIGH INSPIRED TIDAL VOLUME ( ↑ V

)

10.8.2.3 Monitored Patient Data

See

Table 64 for details on the spontaneous inspired tidal volume patient data parameter available during VS

breaths.

10.8.3 Tube Compensation

Tube compensation (TC) is a pressure-supported spontaneous breath type available in SIMV, SPONT and BiLevel modes. When TC is enabled, the patient’s respiratory muscles are not required to work as hard to draw gases into the lungs as they would in the absence of the pressure assistance provided by the TC feature. This is particularly important for patients whose respiratory systems are already functioning poorly, and would have to exert even greater muscular effort to overcome the increased resistance to flow through the artificial airway.

Tube compensation provides programmable, inspiratory pressure assistance during otherwise unsupported spontaneous breaths. This assists the patient in overcoming the flow resistance of the artificial airway. Pressure is programmed to vary in accordance with the resistance to flow through the artificial airway. The ventilator continuously calculates the pressure differential and adjusts the compensation pressure accordingly.

Tube compensation also includes safety protection, safety checks, and logic checks which prevent the operator from entering certain incompatible settings, such as a large airway size paired with a small predicted body weight.

If the type of humidifier has been changed after running SST with TC, the volume can be adjusted at the same time to avoid a reduction in compensation compliance accuracy.

10.8.3.1 Technical Description

Tube compensation is a spontaneous mode enhancement which assists patients’ spontaneous breaths not already supported by specific pressure-based breath types (such as PS, VS, and PAV+™) by delivering positive pressure proportional to the flow-based, resistive pressure developed across the artificial airway. TC causes the sensation of breathing through an artificial airway to diminish because the TC algorithm instructs the ventilator to develop just the correct amount of forward pressure to offset (cancel) the back pressure developed across the artificial airway during the inspiratory phase. The degree of cancellation can be set by the clinician and is adjustable between 10% an 100% in increments of 5%.

212

Tube compensation can support all unsupported spontaneous breaths for patients with predicted body weights

≥7.0 kg (15.4 lb), and for endotracheal/tracheostomy tubes with an inside diameter (ID) of ≥4.5 mm. TC can be used within SPONT, BiLevel or SIMV, all of which permit unsupported spontaneous breaths. With BiLevel selected,

TC supports spontaneous breaths at both pressure levels.

Tube compensation checks the flow rate every 5, using an internal lookup table which contains the flow-to-pressure relationship of the selected artificial airway, and is used to calculate the amount of pressure needed to overcome all or part of the resistance of the artificial airway. Based the TC setting and the instantaneous flow measurement, the ventilator’s PSOL valves are continually adjusted, adjusting the circuit pressure to match the changing tube-pressure compensation requirements.

10.8.3.2 Tube Compensation Alarms

See

Table 37 for details of the

↑ P

COMP

, ↑ P

VENT

, and ↑ V

alarms associated with TC.

10.8.3.3 Monitored Patient Data

See Table 64 for details of the inspired tidal volume (V

) monitored patient data parameter a associated with TC.

10.8.3.4 Tube Inside Diameter (ID)

The ventilator uses “soft bound” values for estimated tube inside diameter (ID) based on PBW. Soft bounds are ventilator settings that have reached their recommended high or low limits. When adjusting the tube size, if the inside diameter does not align with a valid predicted body weight, a Continue button appears. Setting the ventilator beyond these soft bounds requires the operator to acknowledge the prompt by touching Continue before continuing to adjust the tube size. The limit beyond which the tube ID cannot be adjusted is called a hard bound, and the ventilator emits an invalid entry tone when a hard bound is reached.

Warning: Greater than expected ventilatory support, leading to unknown harm, can result if the specified tube type or tube ID is smaller than the actual tube type or tube ID.

10.8.3.5 Ventilator Settings and Guidelines

The estimation of settings to use with TC is aided by an understanding of the ventilator settings, the data used for determination of the compensation values, and the specified performance or accuracy of the TC function.

The setting for ⤒ P

PEAK

must take the estimated tube compensation into consideration. The target pressure

(compensation) at the patient wye is derived from the knowledge of the approximate airway resistance of the ET or tracheostomy tube being used. The compensation pressure in cmH of PEEP for calculation and setting of ⤒ P

PEAK

O for available tube sizes and gas flows is shown. See

Figure 81, page 214 and Figure 82, page 214

. The estimated compensation must be added to the value

10.8.3.6 Specified Performance

Performance using TC is specified to be ± (0.5 +10% of actual) joules/liter (residual work during inspiration at the

100% support (% Supp) level). Work is computed over the entire inspiratory interval. In terms of ventilation, resistive work is given by the equation:

E END

Work [J/L]

End expiratory pressure

P k

Tracheal pressure

Conversion constant (0.098)[J/c cmH

O x L]

Figure 81 and Figure 82

indicate pressures at steady-state flows for ET tubes and tracheostomy tubes, respectively, at 100% support at the wye for sizes between 4.5 mm and 10 mm.

213

Figure 81.

ET Tube Target Pressure vs. Flow

1 Pressure (cmH

2 Flow (L/min)

Figure 82.

Tracheostomy Tube Target Pressure vs. Flow

1 Pressure (cmH

2 Flow (L/min)

214

10.8.4 Proportional Assist Ventilation (PAV+™)

PAV+™ is another type of spontaneous breath. For detailed description of the operating theory, see

Chapter 14 .

10.9 A/C Mode

When the ventilator is in assist-control (A/C) mode, only mandatory breaths are delivered. These mandatory breaths can be PC, VC, or VC+ breaths. See

Section 10.7, Mandatory Breath Delivery, page 206 for a more detailed

explanation of VC+ breaths. As for any mandatory breath, the triggering methods can be P-Trig, ⩒ -Trig, time-triggered, or operator initiated. If the ventilator senses the patient initiating the breath, a PIM or assist breath is delivered. Otherwise, VIM breaths (control breaths) are delivered based on the set respiratory rate. The length of the breath period is defined as: where:

T b

= breath period (seconds) f = set respiratory rate (breaths per minute)

The inspiratory phase length is determined by the current breath delivery settings. At the end of the inspiratory phase, the ventilator enters the expiratory phase as determined by the following equation: where:

= length of the expiratory phase (seconds)

= length of inspiratory phase including plateau time, T

(seconds)

Figure 83 illustrates A/C breath delivery when there is no patient inspiratory effort detected (all inspirations are

VIMs).

Figure 83.

No Patient Inspiratory Effort Detected

1 VIM

2 T b

Figure 84 shows A/C breath delivery when patient inspiratory effort is detected. The ventilator allows PIM breaths

to be delivered at a rate greater than or equal to the set respiratory rate.

Figure 84.

Patient Inspiratory Effort Detected

1 PIM

2 T b set

215

Figure 85 illustrates A/C breath delivery when there are both PIM and VIM breaths delivered.

Figure 85.

Combined VIM and PIM Breaths

1 VIM

2 PIM

3 T b set

If changes to the respiratory rate are made, they are phased in during exhalation only. The new breath period depends on the new respiratory rate, is based on the start of the current breath, and follows these rules:

• The current breath’s inspiratory time is not changed.

• A new inspiration is not delivered until at least 200 ms of exhalation have elapsed.

• The maximum time t until the first VIM for the new respiratory rate is delivered is 3.5 times the current inspiratory time or the length of the new breath period (whichever is longer), but t is no longer than the old breath period.

• If the patient generates a PIM after the ventilator recognizes the rate change and before time t , the new rate begins with the PIM.

10.9.1 Changing to A/C Mode

Switching to A/C mode from any other mode causes the ventilator to phase in a VIM and set the start time for the beginning of the next A/C breath period. Following this VIM, and before the next A/C period begins, the ventilator responds to the patient’s inspiratory efforts by delivering mandatory breaths.

The first A/C breath (VIM breath) is phased in while following these rules:

• The breath is not delivered during an inspiration.

• The breath is not delivered during the restricted phase of exhalation.

• The ventilator ensures the apnea interval elapses at least 5 seconds after the beginning of exhalation.

• Any other specially scheduled event (for example, a respiratory mechanics maneuver or any pause maneuver) is canceled and rescheduled at the next interval.

When the first VIM of the new A/C mode is delivered depends on the mode and breath type active when the mode change is requested.

10.10 SIMV Mode

Synchronous Intermittent Mandatory Ventilation (SIMV) mode is a mixed ventilation mode allowing both mandatory and spontaneous breaths using pressure- or flow-triggering. The mandatory breaths can be PC, VC, or VC+, and the spontaneous breaths are pressure-assisted with either PS or TC. SIMV guarantees one mandatory breath per SIMV breath period, which is either a PIM or VIM. OIM breaths are allowed in SIMV and are delivered at the setting selected for Mandatory Type.

Figure 86

shows the two parts of the SIMV breath period.

216

Figure 86.

Mandatory and Spontaneous Intervals

1 T b

= SIMV breath period (includes T m

and T s

)

2 T m

= Mandatory interval (reserved for a PIM breath)

3 T s

= Spontaneous interval (VIM delivered if no PIM delivered during T m

)

The first part of the period is the mandatory interval ( T m

) which is reserved for a PIM. If a PIM is delivered, the T interval ends and the ventilator switches to the second part of the period, the spontaneous interval ( T s m

), which is reserved for spontaneous breathing for the remainder of the breath period. At the end of an SIMV breath period, the cycle repeats. If a PIM is not delivered during the mandatory interval, the ventilator delivers a VIM at the end

of the mandatory interval, then switches to the spontaneous interval. Figure 87 shows an SIMV breath period

where a PIM is delivered within the mandatory interval. Any subsequent trigger efforts during Its yield spontaneous breaths. As shown, T m

transitions to T s

when a PIM is delivered.

Figure 87.

PIM Delivered Within Mandatory Interval

2 3

1 PIM

2 T m

(T m

transitions to T s

when a PIM is delivered)

VEN_10766_B

3 T s

(subsequent trigger efforts during T s

yield spontaneous breaths)

4 T b

Figure 88 shows an SIMV breath period where a PIM is not delivered within the mandatory interval.

Figure 88.

PIM Not Delivered Within the Mandatory Interval

2 3

VEN_10767_B

1 VIM

2 T m

(VIM delivered at end of T m

if no PIM delivered during T m

3 T s

4 T b

In SIMV, mandatory breaths are identical to those in A/C mode if the ventilator’s respiratory rate setting is greater than the patient’s natural respiratory rate. Spontaneous breaths are identical to those in SPONT mode if the ventilator setting for respiratory rate is significantly below the patient’s natural respiratory rate. Patient triggering must meet the requirements for pressure and flow sensitivity.

The procedure for setting the respiratory rate in SIMV is the same as in A/C mode. Once the respiratory rate f is set, the SIMV interval period T b

in seconds is:

Tb = 60/f

217

During the mandatory interval, if the patient triggers a breath according to the current setting for pressure or flow sensitivity, the ventilator delivers a PIM. Once a mandatory breath is triggered, T m

ends, T trigger efforts yield spontaneous breaths. During the spontaneous interval, the patient can take as many spontaneous breaths as allowed. If no PIM or OIM is delivered by the end of the mandatory interval, the ventilator delivers a VIM and transitions to the spontaneous interval at the beginning of the VIM.

begins, and any further

The SIMV breathing algorithm delivers one mandatory breath each period interval, regardless of the patient’s ability to breathe spontaneously. Once a PIM or VIM is delivered, all successful patient efforts yield spontaneous breaths until the cycle interval ends. The ventilator delivers one mandatory breath during the mandatory interval, regardless of the number of successful patient efforts detected during the spontaneous interval. (An OIM delivered during the mandatory interval satisfies the mandatory breath requirement, and causes to T s

T m

to transition

The maximum mandatory interval for any valid respiratory rate setting in SIMV is defined as the lesser of:

• 0.6 × the SIMV interval period ( T b

)

• 10 seconds

There is no minimum value for T m

In SIMV, the interval from mandatory breath to mandatory breath can be as long as 1.6 × the SIMV period interval

(but no longer than the period interval +10 seconds). At high respiratory rates and too-large tidal volumes, breath stacking (the delivery of a second inspiration before the first exhalation is complete) is likely. In volume ventilation, breath stacking during inspiration and early exhalation leads to hyperinflation and increased airway and lung pressures, which can be detected by a high pressure limit alarm. In pressure control ventilation (with inspiratory pressure remaining constant), breath stacking leads to reduced tidal volumes, which can be detected by the low tidal volume and minute ventilation alarms.

In SIMV mode it is possible for the respiratory rate to drop temporarily below the f setting (unlike A/C mode, in which f

TOT

is always greater than or equal to the f setting). If the patient triggers a breath at the beginning of a breath period, then does not trigger another breath until the maximum mandatory interval for the following breath has elapsed, a monitored respiratory rate less than the respiratory rate setting can result.

If a spontaneous breath occurs toward the end of the spontaneous interval, inspiration or exhalation can still be in progress when the SIMV interval ends. No VIM, PIM, or OIM is allowed during the restricted phase of exhalation.

In the extreme, one or more expected mandatory breaths could be omitted. When the expiratory phase of the spontaneous breath ends, the ventilator reverts to its normal criteria for delivering mandatory breaths.

If an OIM is detected during the mandatory interval, the ventilator delivers the currently specified mandatory breath then closes delivered during T s

T m

and transitions to T s

. If an OIM is detected during the spontaneous interval, the ventilator delivers the currently specified mandatory breath, but the SIMV cycle timing does not restart if OIM breaths are

10.10.1 Changing to SIMV Mode

Switching the ventilator to SIMV from any other mode, causes the ventilator to phase in a VIM and set the start time for the next SIMV period. Following this VIM, but before the next SIMV period begins, the ventilator responds to successful patient inspiratory efforts by delivering spontaneous breaths. The first SIMV VIM breath is phased in according to the following rules:

• The VIM breath is not delivered during an inspiration or during the restricted phase of exhalation.

• If the current mode is A/C, the first SIMV VIM is delivered after the restricted phase of exhalation plus the shortest of the following intervals, referenced to the beginning of the last or current inspiration: 3.5 T

, or the length of the current breath period.

, current

• If the current mode is SPONT, and the current or last breath type was spontaneous or OIM, the first SIMV VIM is delivered after the restricted phase of exhalation plus the shortest of the following intervals, referenced to the beginning of the last or current inspiration: 3.5x T

or current T

218

• If the current mode is BiLevel in the P

H reduced to P

state and the current breath is mandatory, the PEEP level will be

once the expiratory phase is detected

• The time t until the first VIM of the new A/C mode is the lesser of:

– PEEP transition time +2.5 × duration of the active gas delivery phase

– the length of the apnea interval (T

)

– the length of the current breath cycle

• If the current mode is BiLevel in the P

state and the current breath is spontaneous, the PEEP level will be reduced once the expiratory phase is detected.

• The time t until the first VIM of the new A/C mode is the lesser of:

– PEEP transition time +2.5× duration of the spontaneous inspiration

– the start time of the spontaneous breath + the length of the apnea interval (T

• If the current mode is BiLevel in the P

L of the new A/C mode is the lesser of:

state and the current breath is mandatory, the time t until the first VIM

– PEEP transition time +2.5 × duration of the active gas delivery phase

– the length of the apnea interval (T

)

– the length of the current breath cycle

• If the current mode is BiLevel in the P

L time has occurred during P

state and the current breath is spontaneous and the spontaneous start

, the time t until the first VIM of the new A/C mode is the lesser of:

– 3.5 × duration of the spontaneous inspiration

– the length of the apnea interval (T

)

– the length of the current breath cycle

• If the current mode is BiLevel in the P

L time has occurred during P

state and the current breath is spontaneous and the spontaneous start

, the time t until the first VIM of the new A/C mode is the lesser of:

– PEEP transition time +2.5 × duration of the spontaneous inspiration

– the start time of the spontaneous breath + the length of the apnea interval (T

)

If the command to change to SIMV occurs after the restricted phase of exhalation has ended, and before a next breath or the apnea interval has elapsed, the ventilator delivers the first SIMV VIM at the moment the command is recognized.

The point at which the new rate is phased in depends on the current phase of the SIMV interval and when the rate change command is accepted. If the rate change occurs during the mandatory interval, the maximum mandatory interval is that for the new or old rate, whichever is less. If the patient generates a successful inspiratory effort during the spontaneous interval, the ventilator responds by delivering a spontaneous breath.

Respiratory rate changes are phased in during exhalation only. The new SIMV interval is determined by the new respiratory rate and is referenced to the start of the current SIMV period interval, following these rules:

• Inspiratory time (T

) of current breath is neither truncated nor extended.

• The new inspiration is not delivered until 200 ms of exhalation have elapsed.

The time until the new SIMV interval begins is:

• whichever is greater: the new SIMV period interval or 3.5 × the last or current T

• but not greater than the current SIMV period interval.

219

10.11 Spontaneous (SPONT) Mode

In SPONT mode, the patient initiates inspiration according to the trigger type in effect, but OIM breaths are allowed which are delivered with the currently specified mandatory breath parameters. The following spontaneous breath types are available in SPONT mode:

• PS

• VS

• TC

• PAV+™

The inspiratory phase begins when the ventilator detects patient effort during the ventilator’s expiratory phase.

Breath delivery during the inspiratory phase is determined by the settings for pressure support, PEEP, rise time%, and expiratory sensitivity, unless the breath is an OIM breath.

If tube compensation (TC), or proportional assist ventilation (PAV+™) is selected as the spontaneous type, breath delivery during the inspiratory phase is determined by the settings for % support (% Supp), expiratory sensitivity, tube ID, and tube type.

Note: Given the current ventilator settings, if PAV+™ would be an allowable spontaneous type (except that tube

ID <6 mm) then PAV+™ becomes selectable. If selected, tube ID is set to its New Patient default value based on the

PBW entered. An attention icon for tube ID appears.

If Volume Support (VS) is selected as the spontaneous type, breath delivery during the inspiratory phase is determined by rise time%, volume support level (V

T SUPP

), expiratory sensitivity, and PEEP.

Inspiratory pauses are only possible during OIM breaths, and expiratory pauses are not allowed during SPONT.

Expiratory trigger methods include:

• E

SENS

(% flow deceleration from peak inspiratory flow)

• PBW based time limit (T

too long)

• ↑ P

PEAK

• Inspiratory tidal volume limit (for VS only)

• Airway Pressure Cycling method

10.11.1 Changing to SPONT Mode

If the operator changes to SPONT mode during an A/C or SIMV inspiration (mandatory or spontaneous), the inspiration is completed, unaffected by the mode change. Because SPONT mode has no special breath timing requirements, the ventilator then enters the expiratory phase and waits for the detection of patient inspiratory effort, a manual inspiration, or apnea detection.

10.12 Apnea Ventilation

When a patient stops breathing or is no longer being ventilated, it is called apnea. When apnea is detected by the ventilator the ventilator alarms and delivers apnea ventilation according to the current apnea ventilation settings.

10.12.1 Apnea Detection

The ventilator declares apnea when no breath has been delivered by the time the operator-selected apnea interval elapses, plus a small increment of time (350 ms). This increment allows time for a patient who has begun to initiate a breath to trigger inspiration and prevent the ventilator from declaring apnea when the apnea interval is equal to the breath period.

The apnea timer resets whenever an inspiration begins, regardless of whether the inspiration is patient-triggered, ventilator-triggered, or operator-initiated. The ventilator then sets a new apnea interval beginning from the start of the current inspiration. To hold off apnea ventilation, another inspiration must be delivered before (the current

220

10 apnea interval +350 ms) elapses. Apnea detection is suspended during a disconnect, occlusion, or safety valve open (SVO) state.

Apnea is not declared when the apnea interval setting equals or exceeds the breath period. For example, if the respiratory rate setting is 4/min, an apnea interval of 15 seconds or more means apnea cannot be detected. The ventilator bases apnea detection on inspiratory (not expiratory) flow, and allows detection of a disconnect or occlusion during apnea ventilation. Apnea detection is designed to accommodate interruptions to the typical breathing pattern due to other ventilator features that temporarily extend the inspiratory or expiratory intervals

(rate changes, for example), but still detect a true apnea event.

Figure 89 shows an apnea breath where T

equals the breath period.

Figure 89.

Apnea Interval Equals Breath Period

1 2

3 3

1 T b0

2 T b1

3 PIM

4 T

(apnea interval)

Figure 90 shows an apnea breath with T

greater than the breath period.

Figure 90.

Apnea Interval Greater Than Breath Period

3 4

VEN_10769_B

1 T b0

2 T b1

3 PIM

4 VIM

5 T

(apnea interval)

Figure 91 shows an apnea breath with T

less than the breath period.

Figure 91.

Apnea Interval Less Than Breath Period

1 2

VEN_10770_B

3 4 5 5

7 8

VEN_10771_B

221

1 T b0

2 T b1

3 PIM

4 Dashed line indicates a PIM to avoid apnea

5 Apnea VIM

6 Apnea interval

7 Apnea T b0

8 Apnea ventilation

9 T b

< T b

)

10.12.2 Transition to Apnea Ventilation

When apnea is declared, the ventilator delivers apnea ventilation according to the current apnea ventilation settings and displays the apnea settings on the graphical user interface (GUI). Regardless of the apnea interval setting, apnea ventilation cannot begin until inspiration of the current breath is complete and the restricted phase of exhalation has elapsed.

10.12.3 Settings Changes During Apnea Ventilation

All apnea and non-apnea settings remain active on the GUI during apnea ventilation. Both non-apnea and apnea settings changes are phased in according to the applicable rules. If apnea ventilation is active, new settings are accepted but not implemented until non-apnea ventilation begins. Allowing key entries after apnea detection allows adjustment of the apnea interval at setup, regardless of whether apnea has been detected. During apnea ventilation, the Manual Inspiration key is active, but expiratory pause and inspiratory pause keys are not active. The increase O

control is active during apnea ventilation, because apnea detection is likely during suctioning.

The apnea respiratory rate must be ≥60/T

Additionally, apnea settings cannot result in an I:E ratio> 1.00:1.

10.12.4 Resetting Apnea Ventilation

Apnea ventilation is intended as an auxiliary mode of ventilation when there is insufficient breath delivery to the patient over a specified period of time. Apnea ventilation can be reset to normal ventilation by the operator (by pressing the Alarm Reset key) or the patient (autoreset). It is also reset when a rate change is made that renders apnea ventilation inapplicable.

If the patient regains inspiratory control, the ventilator returns to the operator-selected mode of non-apnea ventilation. The ventilator determines whether the patient has regained respiratory control by monitoring triggered inspirations and exhaled volume. With exception of PAV+ and TC breath types, if the patient triggers two consecutive inspirations, and the exhaled volume is equal to or greater than 50% of the delivered volume

(including any compliance volume), the ventilator resets to non-apnea ventilation. Exhaled volume is monitored to avoid resetting due to autotriggering caused by large leaks in the patient circuit. During PAV+ and TC, on the first patient triggered breath, the ventilator returns to PAV+ or TC. PAV+ reenters its Startup phase to estimate the patient’s respiratory mechanics values. TC begins immediately at the set percent support.

10.12.5 Apnea Ventilation in SIMV

The following strategy is designed to allow SIMV to avoid triggering apnea ventilation if a VIM breath can be delivered instead:

• If the apnea interval (T

) elapses at any time during the mandatory interval, the ventilator delivers a VIM rather than beginning apnea ventilation.

• If T

elapses during the spontaneous interval, apnea ventilation begins.

Figure 92

shows an illustration of how SIMV is designed to deliver a VIM rather than trigger apnea ventilation, when possible.

222

Figure 92.

Apnea Ventilation in SIMV

1 1 1

2 3

1 T b

2 Last breath (PIM)

3 VIM

4 T m max

6 7

VEN_10768_B

5 T

6 T m

(If T

elapses during T m

, ventilator delivers a VIM rather than beginning apnea ventilation

7 T s

10.12.6 Phasing in New Apnea Intervals

How a new apnea interval is phased in depends on whether or not apnea ventilation is active. If apnea ventilation is active, the ventilator accepts and implements the new setting immediately. During normal ventilation (that is, apnea ventilation is not active), these rules apply:

• If the new apnea interval setting is shorter than the current (or temporarily extended) apnea interval, the new value is implemented at the next inspiration.

• If the new apnea interval setting is longer than the current (or temporarily extended) apnea interval, the old interval is extended to match the new interval immediately.

10.13 Detecting Occlusion and Disconnect

10.13.1 Occlusion

The ventilator detects severe patient circuit occlusions to protect the patient from excessive airway pressures, or from receiving little or no gas. Occlusions require immediate attention to remedy.

The ventilator detects a severe occlusion if:

• The inspiratory or expiratory limb of the breathing circuit is partially or completely occluded (condensate or secretions collected in a gravity-dependent loop, kinked or crimped tubing, etc.).

• The ventilator exhaust port is blocked or resistance through the port is too high.

The ventilator checks the patient circuit for occlusions during all modes of breathing (except Stand-By state and

Safety Valve Open) at delivery of every breath. Once the circuit check begins, the ventilator detects a severe occlusion of the patient circuit within 200 ms. The ventilator checks the exhaust port for occlusions during the expiratory phase of every breath (except during disconnect and safety valve open). Once the exhaust port check begins, the ventilator detects a severe occlusion within 100 ms following the first 200 ms of exhalation. All occlusion checking is disabled during pressure sensor autozeroing.

When an occlusion is detected, an alarm sounds, the ventilator enters the OSC (Occlusion Status Cycling) state and displays a message indicating the length of time the patient has gone without ventilation (how long the ventilator has been in OSC). This alarm has the capability to autoreset, since occlusions such as those due to patient activity

(for example, crimped, or kinked tubing) can correct themselves.

Once a severe occlusion is detected, the ventilator acts to minimize airway pressure. Because any severe occlusion places the patient at risk, the ventilator minimizes the risk while displaying the length of time the patient has been without ventilatory support. Severe occlusion is detected regardless of what mode or triggering strategy is in effect. When a severe occlusion is detected, the ventilator terminates normal ventilation, terminates any active

223

audio paused interval, annunciates an occlusion alarm, and enters the safe state (exhalation and inspiratory valve de-energized and safety valve open) for 15 seconds or until inspiratory pressure drops to 5 cmH whichever comes first.

O or less,

During a severe occlusion, the ventilator enters OSC, in which it periodically attempts to deliver a pressure-based breath while monitoring the inspiration and expiratory phases for the existence of a severe occlusion. If the severe occlusion is corrected, the ventilator detects the corrected condition after two complete OSC breath periods during which no occlusion is detected. When the ventilator delivers an OSC breath, it closes the safety valve and waits 500 ms for the safety valve to close completely, delivers a breath with a target pressure of 15 cmH

O for

2000 ms, then cycles to exhalation. This breath is followed by a mandatory breath according to the current settings, but with PEEP =0 and O

% equal to 100% for adult/pediatric circuit types or 40% for neonatal circuits.

During OSC (and only during OSC), the ⤒ P interfere with the ability of the ventilator to detect a corrected occlusion. When the ventilator does not detect a severe occlusion, it resets the occlusion alarm, re-establishes PEEP, and reinstates breath delivery according to current settings.

PEAK

(high circuit pressure) alarm limit is disabled to ensure it does not

Inspiratory and expiratory pause, and manual inspirations are suspended during a severe occlusion. Pause maneuvers are canceled by a severe occlusion. During a severe occlusion, ventilator settings changes are possible.

Severe occlusions are not detected when the ventilator is in the safety valve open (SVO) state.

A corrected occlusion is detected within 15 seconds.

10.13.2 Disconnect

A circuit disconnect condition is detected when the ventilator cannot ensure that a patient is receiving sufficient tidal volume (due to a large leak or disconnected patient circuit). This discussion applies when Leak Sync is disabled.

When a disconnect is detected, an alarm sounds, the ventilator indicates that a disconnect has been detected, and displays a message indicating the length of time the patient has gone without ventilation.

Patient data are not displayed during a circuit disconnect condition.

The ventilator monitors the expiratory pressure and flow, delivered volume, and exhaled volume to declare a disconnect using any of these methods:

• The ventilator detects a disconnect when the expiratory pressure transducer measures no circuit pressure and no exhaled flow during the first 200 ms of exhalation. The ventilator postpones declaring a disconnect for another 100 ms to allow an occlusion (if detected) to be declared first, because it is possible for an occlusion to match the disconnect detection criteria.

• Despite many possible variations of circuit disconnections and large leaks, it is possible for a patient to generate some exhaled flow and pressure. The ventilator then uses the disconnect sensitivity (D setting to detect a disconnect.

SENS

, the percentage of delivered volume lost during the expiratory phase of the same breath to declare a disconnect)

• If the disconnect occurs during a spontaneous breath, a disconnect is declared when the inspiration is terminated by maximum inspiratory time (or the ⤒ T

I SPONT

limit setting when ventilation type is non-invasive

[NIV]) and the ventilator detects inspiratory flow rising to the maximum allowable.

• If the disconnect occurs at the endotracheal tube, the exhaled volume will be much less than the delivered volume for the previous inspiration. The ventilator declares a disconnect if the exhaled volume is lower than the D

SENS

setting for three consecutive breaths. The D

SENS

setting helps avoid false detections due to leaks in the circuit or the patient’s lungs, and the three-consecutive-breaths requirement helps avoid false detections due to a patient out-drawing the ventilator during volume control (VC) breaths.

• Flow less than a value determined using the D

SENS consecutive seconds during exhalation.

setting and pressure less than 0.5 cmH

O detected for 10

224

Warning: When ventilation type is NIV, and D

SENS leaks and some disconnect conditions.

setting is turned OFF, the system may not sound an alarm for

Once the ventilator detects a patient circuit disconnect, the ventilator declares a high-priority alarm and discontinues breath delivery, regardless of what mode (including apnea) was active when the disconnect was detected. If there is an active alarm audio paused interval when the disconnect occurs, the audio paused interval is not canceled. The ventilator displays the length of time the patient has been without ventilatory support. During the disconnect, the exhalation valve closes, idle flow (10 L/min flow with Leak Sync disabled and 20 L/min with

Leak Sync enabled) begins, and breath triggering is disabled. A message appears identifying how long the patient has gone without ventilatory support.

The ventilator monitors both expiratory flow and circuit pressures to detect reconnection. The ventilator declares a reconnect if any of the following criteria are met for the applicable time interval:

• Exhaled idle flow within the reconnect threshold is detected

• Inspiratory and expiratory pressures are both above or both below reconnect threshold levels

• Inspiratory pressure rises to a reconnect level

If the disconnect condition is corrected, the ventilator detects the corrected condition within one second.

Ventilator triggering, apnea detection, expiratory and inspiratory pause, manual inspirations, and programmed maneuvers or one-time events are suspended during a patient circuit disconnect condition. Spirometry is not monitored during a disconnect, and all alarms based on spirometry values are disabled. During a disconnect condition, ventilator settings changes are possible.

If the disconnect alarm is autoreset or manually reset, the ventilator re-establishes PEEP. Once PEEP is reestablished, the ventilator reinstates breath delivery according to settings in effect before the disconnect was detected.

10.13.3 Annunciating Occlusion and Disconnect Alarms

Occlusion and disconnection cannot be declared at the same time. Therefore, the ventilator annunciates only the first event to be declared.

Circuit disconnect detection is not active during OSC, SVO, or prior to patient connection.

10.14 Respiratory Mechanics

See Section 4.9, Respiratory Mechanics Maneuvers, page 111

for instructions on how to perform these maneuvers.

In addition to inspiratory pause and expiratory pause maneuvers, the ventilator can provide other respiratory maneuvers, including negative inspiratory force (NIF), occlusion pressure (P

0.1

) and vital capacity (VC), as well as automatic calculations of lung function and performance, such as dynamic compliance (C

DYN resistance (R

DYN

), peak expiratory flow (PEF), end expiratory flow (EEF), C

) and dynamic

/C, and peak spontaneous flow (PSF).

Respiratory maneuvers can be performed in all breathing modes (except as noted) but are not available during the following conditions:

• Apnea ventilation

• Safety PCV

• Occlusion Status Cycling (OSC)

• Non-invasive ventilation (NIV)

• When the circuit type is neonatal

• SVO

• Ventilator is in Stand-By state

• When any other respiratory maneuver has already taken place during the same breath

225

The GUI also displays any maneuver request, distinguishing between requests that are accepted or rejected, and any maneuver that has begun, ended, or has been canceled.

When a maneuver is selected, a GUI information panel is opened, displaying the maneuver name, user prompts and controls, and recent calculated results.

Any maneuver is canceled automatically upon declaration of any of the following alarms:

• ↑ P

PEAK

alarm

• ↑ P

VENT

alarm

• ↑ V

The following respiratory mechanics maneuvers are not available in BiLevel ventilation:

• P

0.1

– occlusion pressure

• NIF – negative inspiratory force

• VC – vital capacity

10.14.1 Inspiratory Pause

Note: Inspiratory pause and expiratory pause maneuvers can be performed directly by pressing the respective keys on the GUI or by swiping the Menu tab on the left side of the GUI. For more information on how to perform

respiratory mechanics maneuvers from the Menu tab, See Section 4.9, Respiratory Mechanics Maneuvers, page 111

An inspiratory pause extends the inspiratory phase of a single mandatory breath for the purpose of measuring end inspiratory circuit pressure which is used to calculate static compliance of the patient’s lungs and thorax (C

STAT

), static resistance of the respiratory system (R

STAT

), and inspiratory plateau pressure (P

PL to equalize, revealing the actual lung inflation pressure during a no-flow condition. An inspiratory pause can be either automatically or manually administered, and is only available during the next mandatory breath in A/C,

SIMV, BiLevel or SPONT modes. In BiLevel, an inspiratory pause maneuver is scheduled for the next inspiration prior to a transition from P

to P

. Only one inspiratory pause is allowed per breath. An inspiratory pause cannot occur during apnea ventilation, safety PCV, Stand-By state, Occlusion, and SVO.

). To calculate these pressures, the inspiratory and exhalation valves are closed, allowing pressures on both sides of the artificial airway

An automatic inspiratory pause begins when the inspiratory pause key is pressed momentarily or the maneuver is started from the GUI screen. See

Section 4.9, Respiratory Mechanics Maneuvers, page 111

for more information on performing respiratory mechanics maneuvers from the Menu tab on the GUI rather than using the keys on the

GUI. The pause lasts at least 0.5 second but no longer than 3 seconds. A manual inspiratory pause starts by pressing and holding the inspiratory pause key. The pause lasts for the duration of the keypress (up to 7 seconds).

An active manual inspiratory pause is considered complete if any of the following occur:

• The inspiratory pause key is released and at least 2 seconds of inspiratory pause have elapsed or pressure stability conditions have been detected for not less than 0.5 second.

• Pause duration reaches seven 7 seconds.

A manual inspiratory pause maneuver request (if the maneuver is not yet active) will be canceled if any of events

1–10 occur. See

Table 50 .

Table 50.

Inspiratory and Expiratory Pause Events

Event Identifier

Event

There is a loss of communications with the GUI

High ventilator pressure limit ( ⤒ P

VENT

) is reached

High circuit pressure limit ( ⤒ P

PEAK

) is reached

A disconnect is detected

Occlusion is detected

226

Table 50.

Inspiratory and Expiratory Pause Events (continued)

Event Identifier

Apnea is detected

Event

72 seconds have elapsed without an inspiratory pause after one has been requested

INSPIRATION TOO LONG alarm is detected

High inspired tidal volume ( ↑ V

) alarm is detected

High compensation pressure ( ↑ P

COMP

) alarm is detected

Cancel is touched if maneuver is initiated from the GUI screen.

Safety Valve Open (SVO) is detected

Patient trigger effort causes circuit pressure to go below sensitivity. The sensitivity level is the setting value for pressure trigger or the backup pressure value for flow trigger.

BUV is entered

Expiratory pause key is pressed (Inspiratory pause key if maneuver is an expiratory pause)

During a manual inspiratory pause, the maneuver is terminated if any of events 1, 3, 5, 6, 12, or 13 occur. See

Table 50 .

An inspiratory pause maneuver is ignored if the ventilator is in Apnea ventilation, safety PCV, OSC, SVO, BUV, or

Stand-By state.

An active automatic inspiratory pause maneuver is terminated and exhalation begun if any of events 1–12, or 14

occur. See Table 50

The active automatic inspiratory pause maneuver is considered complete if the pause duration reaches 3 seconds or pressure stability conditions have been detected for not less than 0.5 second.

An automatic inspiratory pause maneuver request (if the maneuver is not yet active) will be canceled if events

1–9, 11,12,14, or 15 occur. See Table 50

Other characteristics of inspiratory pause include:

• During an inspiratory pause, the apnea interval (T

) is extended by the duration of the inspiratory pause.

• If the ventilator is in SIMV, the breath period during which the next scheduled VIM occurs will also be extended by the amount of time the inspiratory pause is active.

• All activations of the inspiratory pause control are logged in the Patient Data Log.

• Severe occlusion detection is suspended

• When calculating I:E ratio, inspiratory pause is considered part of the inspiratory phase.

• The expiratory time remains unchanged, and will result in a change in the I:E ratio for the breath that includes the inspiratory phase.

Once the inspiratory pause maneuver is completed the operator can review the quality of the maneuver waveform and accept or reject the maneuver data.

10.14.2 Expiratory Pause

An expiratory pause extends the expiratory phase of a single breath to measure end expiratory lung pressure

(PEEP

) and allows intrinsic PEEP (PEEP

) to be calculated as PEEP

minus set PEEP. The pressures on either side of the artificial airway are allowed to equalize by closing the inspiratory and exhalation valves. Expiratory pause is available in A/C, SIMV, and BiLevel modes. For A/C and SIMV, the expiratory pause maneuver is scheduled for the next end-of-exhalation prior to a mandatory breath. In BiLevel, the expiratory pause occurs at the next

227

end-of-exhalation prior to a transition from P

to P

. Only one expiratory pause per breath is allowed, and the expiratory pause request is rejected if an inspiratory pause has already taken place during the same breath.

A request for an expiratory pause maneuver is ignored in apnea ventilation, safety PCV, SPONT, OSC, BUV, and

Stand-By. See Section 4.9, Respiratory Mechanics Maneuvers, page 111

, for more information on performing these maneuvers from the GUI screen rather than using the keys on the GUI.

Either manual or automatic expiratory pause maneuvers can occur. A momentary press of the expiratory pause key begins an automatic expiratory pause which lasts at least 0.5 second, but no longer than 3.0 seconds. A manual expiratory pause starts by pressing and holding the expiratory pause key and lasts for the duration of the key-press (up to 15 seconds).

An active manual

expiratory pause is terminated if any of events 1–12 occur. See Table 50, page 226 .

An active manual expiratory pause is complete if the expiratory pause key is released and at least 3 seconds of expiratory pause have elapsed, pressure stability conditions have been detected for ≥0.5 second, or pause duration lasts 15 seconds.

An active automatic expiratory pause is terminated if any of events 1, 3, or 11–13 occur. See

Table 50, page 226

An active automatic expiratory pause is complete if pause duration reaches 3 seconds or pressure stability conditions have been detected for ≥0.5 second, or pause duration lasts 15 seconds.

The automatic expiratory pause maneuver request (the maneuver is not yet active) is canceled if events 1–9, 11,

12, or 15 occur:

The automatic expiratory pause maneuver is terminated and inspiration begun if any of events 1, 3, or 11–13

occur. See Table 50, page 226 .

Other characteristics of expiratory pause include:

• During an active manual expiratory pause, severe occlusion detection is suspended.

• When calculating I:E ratio, the expiratory pause is considered part of the expiratory phase.

• During the expiratory pause, the inspiratory time remains unchanged, so the I:E ratio is changed for the breath that includes the expiratory pause.

• All activations of the expiratory pause control are logged in the Patient Data log.

Once the expiratory pause maneuver is completed the operator can review the quality of the maneuver waveform and accept or reject the maneuver data.

10.14.3 Negative Inspiratory Force (NIF) Maneuver

The Negative Inspiratory Force (NIF) maneuver is a coached maneuver where the patient is prompted to draw a maximum inspiration against an occluded airway (the inspiratory and exhalation valves are fully closed).

A NIF maneuver is canceled if:

• Disconnect is detected

• Occlusion is detected

• SVO is detected

• ↑ P

PEAK

alarm is declared

• ↑ P

VENT

alarm is declared

• ↑ V

alarm is declared

• Communications with the GUI is lost

• The maneuver has been active for 30 seconds and an inspiration is not detected

• INSPIRATION TOO LONG alarm is declared

• A manual inspiration is requested

228

When a NIF maneuver is activated, a single pressure-time waveform grid is automatically displayed. During a NIF maneuver, the circuit pressure displays on the waveforms screen and is regularly updated, producing a real-time display.

When an active NIF maneuver ends successfully, the calculated NIF result appears on the waveforms screen and on the maneuver panel. The NIF value displayed represents the maximum negative pressure from PEEP.

When a NIF maneuver ends, a PEEP restoration breath is delivered to the patient, then normal breath delivery resumes.

10.14.4 P

0.1

Maneuver (Occlusion Pressure)

0.1

is the negative airway pressure (delta pressure change) generated during the first 100 of an occluded inspiration. It is an estimate of the neuromuscular drive to breathe.

When a P

0.1

maneuver ends successfully, the calculated airway pressure displays on the waveforms screen and on the maneuver panel. A P activate the maneuver.

0.1

maneuver is terminated if 7 seconds elapse and a trigger has not been detected to

A P

0.1

maneuver is canceled if:

• Disconnect is detected

• Occlusion is detected

• SVO is detected

• ↑ P

PEAK

alarm is declared

• ↑ P

VENT

alarm is declared

• ↑ V

alarm is declared

• INSPIRATION TOO LONG alarm is declared

• Communications with the GUI is lost

• A manual inspiration is requested

10.14.5 Vital Capacity (VC) Maneuver

The Vital Capacity (VC) maneuver is a coached maneuver where the patient is prompted to draw a maximum inspiration (regardless of the current settings) and then to slowly and fully exhale.

When the Vital Capacity maneuver becomes active, the ventilator delivers a spontaneous inspiration in response to patient effort (with P

SUPP

= 0, Rise time% = 50, and E

SENS

= 0), and then allows for a full exhalation effort.

When a Vital Capacity maneuver is requested, a single Volume-Time waveform grid is automatically displayed. A

Vital Capacity maneuver is canceled if:

• Disconnect is detected

• Occlusion is detected

• SVO is detected

• ↑ P

PEAK

alarm is declared

• ↑ P

VENT

alarm is declared

• ↑ V

alarm is declared

• INSPIRATION TOO LONG alarm is declared

• Communications with the GUI is lost

• A manual inspiration is requested

• The maneuver as been active for 15 seconds and inspiration is not detected

• Cancel is touched

229

When an active VC maneuver ends successfully, the calculated expiratory volume displays on the waveforms screen and on the maneuver panel and a PEEP restoration breath is delivered.

10.15 Ventilator Settings

10.15.1 Apnea Ventilation

Apnea ventilation is a backup mode and starts if the patient fails to breathe within the apnea interval (T the operator. T

) set by

defines the maximum allowable length of time between the start of inspiration and the start of the next inspiration. Available settings include mandatory type (PC or VC). For PC breaths the allowable settings are

• Apnea interval (T

)

• Inspiratory pressure (P

)

• Inspiratory time (T

)

• Respiratory rate (f )

For VC breaths, the allowable settings are:

• Apnea interval (T

)

• Flow pattern

• O

• Peak inspiratory flow ( ⩒

MAX

)

• Respiratory rate (f )

• Tidal volume (V

)

During apnea ventilation with PC selected as the mandatory type, rise time% is fixed at 50%, and the constant parameter during a rate change is inspiratory time (T

If apnea is possible (that is, if (60/f ) > T ventilation O

) increasing the non-apnea O

% setting automatically changes apnea

% if it is not already set higher than the new non-apnea O

%. Apnea ventilation O

% does not automatically change by decreasing the non-apnea O

%. Whenever there is an automatic change to an apnea setting, a message appears on the GUI, and the apnea settings screen appears.

During apnea ventilation, changes to all non-apnea ventilation settings are allowed, but the new settings do not take effect until the ventilator resumes normal ventilation. Being able to change T

during apnea ventilation can avoid immediately re-entering apnea ventilation once normal ventilation resumes.

Because the minimum value for T

is 3 seconds, apnea ventilation cannot take place when non-apnea f is greater than or equal to 18/min. The ventilator does not enter apnea ventilation if T

Set T

is equal to the breath period interval.

to a value less than the expected or current breath period interval as a way of allowing the patient to initiate breaths while protecting the patient from the consequences of apnea.

10.15.2 Circuit Type and Predicted Body Weight (PBW)

Together, circuit type and PBW (displayed in lb or kg) provide the basis for new patient values and absolute limits on various ventilator settings such as tidal volume (V

) and Peak flow ( ⩒

MAX

). Run SST to change the circuit type.

Table 51 gives the minimum, maximum, and new patient default values for V

based on circuit type.

Table 51.

Values for V

Based on Circuit Type

Circuit Type

Neonatal

New Patient Default

When mandatory type is

VC+, MAX {2 mL, (mL/kg

Ratio × PBW)} mL; When mandatory type is VC,

Minimum V

2 mL if NeoMode 2.0 soft‐ ware option is installed

Maximum V

315 mL

230

Table 51.

Values for V

Based on Circuit Type (continued)

Circuit Type New Patient Default

MAX {3 mL, (mL/kg Ratio ×

PBW)} mL

Pediatric

Adult mL/kg ratio × PBW mL mL/kg ratio × PBW mL

25 mL

Minimum V

Maximum V

1590 mL

2500 mL

See

Table 64 , V

setting, for more information on V

calculations based on PBW and circuit type.

Table 52.

Peak Flow and Circuit Type (Leak Sync Disabled)

Circuit Type

Neonatal

Maximum peak flow ( ⩒

MAX

) setting

30 L/min

Pediatric

Adult

60 L/min

150 L/min

PBW determines constants for breath delivery algorithms, some user-settable alarms, the high spontaneous inspiratory time limit setting ( ⤒ T

I SPONT

) in NIV, and the non-settable INSPIRATION TOO LONG alarm.

10.15.3 Ventilation Type

There are two ventilation type choices: Invasive and NIV (non-invasive). Invasive ventilation is conventional ventilation used with endotracheal or tracheostomy tubes. All installed software options, breathing modes, breath types, and trigger types are available during Invasive ventilation.

NIV interfaces include non-vented full-faced or nasal masks or nasal prongs. See Section 4.7.2, NIV Breathing

Interfaces, page 107

for a list of interfaces that have been successfully tested with NIV).

NIV enables the ventilator to handle large system leaks associated with these interfaces by providing pressure-based disconnect alarms, minimizing false disconnect alarms, and replacing the INSPIRATION TOO

LONG alarm with a high spontaneous inspiratory time limit ( ⤒ T

I SPONT

) setting and visual indicator.

The following list shows the subset of Invasive settings active during NIV:

• Mode — A/C, SIMV, SPONT. (BiLevel is not available during NIV.)

• Mandatory Type — PC or VC. (VC+ is not available during NIV.)

• Spontaneous Type — PS (TC and VS are not available during NIV.)

During NIV alarm setup, the clinician may set alarms to OFF and must determine if doing so is appropriate for the patient’s condition.

10.15.4 Mode and Breath Type

Specifying the mode defines the types and sequences of breaths allowed for both Invasive and NIV ventilation types.

Table 53.

Modes and Breath Types

Mode

A/C

Mandatory Breath Type

Invasive: VC, VC+ or PC NIV:

VC or PC

Spontaneous Breath Type

Not allowed

SIMV Invasive: PC, VC, or VC+

NIV: VC or PC

Pressure supported (PS) or TC

Sequence

All mandatory (patient-, ventilator-, or operator-ini‐ tiated).

Each new breath begins with a mandatory interval, during which a patient effort yields a synchron‐

231

Table 53.

Modes and Breath Types (continued)

Mode

SPONT

BiLevel (Inva‐ sive ventilation type only)

CPAP

Mandatory Breath Type

Not allowed (PC or VC allowed only for manual inspirations).

VC or PC (allowed only for

OIM breaths)

Spontaneous Breath Type Sequence ized mandatory breath. If no patient effort is detec‐ ted during the mandatory interval, the ventilator delivers a mandatory breath. Subsequent patient efforts before the end of the breath yield spontaneous breaths.

All spontaneous (except for manual inspirations).

Invasive: Pressure supported (PS),

Tube compensated (TC), Volume sup‐ ported (VS), Proportionally assisted

(PAV+™)

NIV: PS

PS, TC

N/A

Combines mandatory and spontaneous breathing modes. See

Chapter 12 for

more information on BiLe‐ vel ventilation.

All spontaneous (except for manual Inspirations).

See Chapter 15

for more information on CPAP.

Breath types must be defined before settings can be specified. There are only two categories of breath type: mandatory and spontaneous. Mandatory breaths are volume controlled (VC) or pressure controlled (PC or VC+).

The ventilator currently offers spontaneous breaths that are pressure supported (PS) volume supported (VS), tube

compensated (TC), or proportionally assisted (PAV+™). Figure 93

shows the modes and breath types available on the ventilator.

Figure 93.

Illustrated Modes and Breath Types

The mode setting defines the interaction between the ventilator and the patient.

• Assist/control (A/C) mode allows the ventilator to control ventilation within boundaries specified by the practitioner. All breaths are mandatory, and can be PC, VC, or VC+.

• Spontaneous (SPONT) mode allows the patient to control ventilation. The patient must be able to breathe independently, and exert the effort to trigger ventilator support.

• Synchronous Intermittent Mandatory Ventilation (SIMV) is a mixed mode that allows a combination of mandatory and spontaneous interactions. In SIMV, the breaths can be spontaneous or mandatory, mandatory breaths are synchronized with the patient’s inspiratory efforts, and breath delivery is determined by the f setting.

232

• BiLevel is a mixed mode that combines both mandatory and spontaneous breath types. Breaths are delivered in a manner similar to SIMV mode with PC selected, but providing two levels of pressure. The patient is free to initiate spontaneous breaths at either pressure level during BiLevel.

Changes to the mode are phased in at the start of inspiration. Mandatory and spontaneous breaths can be flowor pressure-triggered.

The ventilator automatically links the mandatory type setting to the mode setting. During A/C or SIMV modes, once the operator has specified volume or pressure, the ventilator displays the appropriate breath parameters.

Changes in the mandatory type are phased in at the start of inspiration.

10.15.5 Respiratory Rate (f)

The f setting determines the minimum number of mandatory breaths per minute for ventilator-initiated mandatory breaths in A/C, SIMV, and BiLevel modes.If the mode is A/C or SIMV and VC is the breath type, specifying

⩒

MAX

and flow pattern determines T

, T

, and I:E. In PC breaths, specifying T

automatically determines the other timing variables. See

Section 10.15.13, Inspiratory Time, page 235 for an explanation of the interdependencies of f,

, T

and I:E. Changes to the f setting are phased in at the start of inspiration.

The ventilator does not accept a proposed f setting if it would cause the new T the T

or T

to be less than 0.2 second,

to be greater than 8 seconds, or I:E ratio greater than 4.00:1. (The ventilator also applies these restrictions to a proposed change to the apnea respiratory rate, except that apnea I:E cannot exceed 1.00:1. An exception to this rule occurs in BiLevel ventilation where the proposed f setting will allow the I:E ratio to be greater than 4.00:1 only until the minimum T

is reached.

10.15.6 Tidal Volume

The tidal volume (V

The delivered V

) setting determines the volume of gas delivered to the patient during a VC mandatory breath.

is compensated for BTPS and patient circuit compliance. Changes to the V in at the start of inspiration. The V

setting only affects the delivery of mandatory breaths.

setting are phased

When proposing a change to the V

setting, the ventilator compares the new value with the settings for f, ⩒

MAX flow pattern, and T

. If the proposed setting would result in an I:E ratio that exceeds 4.00:1 or a T

I seconds or less than 0.2 second, or a T

less than 0.2 second, the ventilator disallows the change.

greater than 8

10.15.7 Peak Inspiratory Flow

The peak inspiratory flow ( ⩒

MAX

) setting determines the maximum rate of delivery of tidal volume to the patient during mandatory VC breaths, only. Changes to ⩒

MAX

are phased in at the start of inspiration. Mandatory breaths are compliance compensated, even at the maximum ⩒

MAX

setting. Circuit compliance compensation does not cause the ventilator to exceed the ventilator’s maximum flow capability.

When proposing a change to the ⩒

MAX

setting, the ventilator compares the new value with the settings for ⩒

, f, flow pattern, and T

. It is impossible to set a new ⩒

MAX

that would result in an I:E ratio that exceeds 4.00:1, or a T greater than 8.0 seconds or less than 0.2 second, or a T

less than 0.2 second.

10.15.8 Plateau Time

The plateau time (T

) setting determines the amount of time inspiration is held in the patient’s airway after inspiratory flow has ceased. T

is available only during VC mandatory breaths (for A/C and SIMV mode, and operator-initiated mandatory breaths). T are phased in at the start of inspiration.

is not available for PC mandatory breaths. Changes to the T

setting

When proposing a change to the T settings for V

4.00:1, or a T

, f, ⩒

MAX

setting, the ventilator computes the new I:E ratio and TI, given the current

, and flow pattern. It is impossible to set a new T

greater than 8 seconds or less than 0.2 second, or a T

is considered part of the inspiratory phase.

that would result in an I:E ratio that exceeds

less than 0.2 second. For the I:E ratio calculation,

233

10.15.9 Flow Pattern

The flow pattern setting defines the gas flow pattern of volume-controlled (VC) mandatory breaths only. The selected values for V are held constant, T

and ⩒

MAX

apply to both the square or descending ramp flow patterns. If V

and ⩒

MAX

and

approximately halves when the flow pattern changes from descending ramp to square (and approximately doubles when flow pattern changes from square to descending ramp), and corresponding changes to the I:E ratio also occur. Changes in flow pattern are phased in at the start of inspiration.

The settings for flow pattern, V

,f, T

, and ⩒

MAX

are interrelated. If any setting change would cause any of the following, the ventilator does not allow that change

• I:E ratio >4:1

• T

>8.0 seconds or T

<0.2 second

• T

<0.2 second

10.15.10 Flow Sensitivity

The flow sensitivity ( ⩒

SENS

) setting defines the rate of flow inspired by a patient that triggers the ventilator to deliver a mandatory or spontaneous breath. When ⩒ -Trig is selected, a base flow of gas (1.5 L/min) travels through the patient circuit during the ventilator’s expiratory phase. Once a value for flow sensitivity is selected, the ventilator delivers a base flow equal to ⩒

SENS

+1.5 L/min (base flow is not user- selectable). When the patient inhales and their inspiratory flow exceeds the

Reductions to ⩒

SENS

⩒

SENS

setting, a trigger occurs and the ventilator delivers a breath.

are phased in immediately, while increases are phased in at the start of exhalation.

When ⩒

SENS

is active, it replaces pressure sensitivity (P

SENS

⩒

SENS controlled, and apnea ventilation). When ⩒

SENS

). The ⩒

SENS

is active, a backup P

setting has no effect on the P

SENS

setting of 2 cmH the patient’s inspiratory effort, even if the flow sensors do not detect flow.

SENS

can be active in any ventilation mode (including pressure supported, volume controlled, pressure

setting.

O is in effect to detect

Although the minimum ⩒

SENS

setting of 0.2 L/min (adult/pediatric circuit types) or 0.1 L/min (neonatal circuit type) can result in autotriggering, it can be appropriate for very weak patients. The maximum setting of 20 L/min

(adult/pediatric circuit types) or 10 L/min (neonatal circuit type) is intended to avoid autotriggering when there are significant leaks in the patient circuit.

10.15.11 Pressure Sensitivity

The pressure sensitivity (P patient-initiated breath (either mandatory or spontaneous). Changes to P

SENS

) setting selects the pressure drop below baseline (PEEP) required to begin a

setting has no effect on the ⩒

SENS

are phased in immediately. The

setting and is active only if the trigger type is P-Trig.

Lower P

SENS

settings provide greater patient comfort and require less patient effort to initiate a breath. However, fluctuations in system pressure can cause autotriggering at very low settings. The maximum P autotriggering under worst-case conditions if patient circuit leakage is within specified limits.

SENS

setting avoids

10.15.12 Inspiratory Pressure

The inspiratory pressure (P

) setting determines the pressure at which the ventilator delivers gas to the patient during a PC mandatory breath. The P

setting only affects the delivery of PC mandatory breaths. The selected P

is the pressure above PEEP. (For example, if PEEP is set to five cmH to the patient at 25 cmH

O.) Changes to the P

O, and P

is 20 cmH

O, the ventilator delivers gas

setting are phased in at the start of inspiration.

The sum of PEEP + P

+2 cmH

O cannot exceed the high circuit pressure ( ⤒ P

PEAK

) limit. To increase this sum of pressures, first raise the ⤒ P

PEAK

5 cmH

limit before increasing the settings for PEEP or P

O and the maximum value is 90 cmH

. The minimum value for P

234

10.15.13 Inspiratory Time

The inspiratory time (T mandatory breaths. The ventilator accepts a setting as long as the resulting I:E ratio and T

Changes to T

setting) determines the time during which an inspiration is delivered to the patient for PC

phase in at the start of inspiration. Directly setting T

settings are valid.

in VC mandatory breaths is not allowed.

The ventilator rejects settings that result in an I:E ratio greater than 4.00:1, a T

0.2 second, or a T

greater than 8 seconds or less than

less than 0.2 second to ensure the patient has adequate time for exhalation.

Setting f and T

automatically determines the value for I:E and T

This equation summarizes the relationship between T

, I:E, T

, and breath period time:

If the f setting remains constant, any one of the three variables (T

, I:E, or T

) can define the inspiratory and expiratory intervals. If the f setting is low (and additional spontaneous patient efforts are expected), T

can be a more useful variable to set than I:E. As the f setting increases (and the fewer patient-triggered breaths are expected), the I:E setting becomes more relevant. Regardless of which variable is chosen, a breath timing bar always shows the interrelationship between T

, I:E, T

and f.

10.15.14 Expiratory Time

The expiratory time (T

Changes to the T

E value for I:E ratio and T

I of f, T

, T

, and I:E.

) setting defines the duration of exhalation for PC and VC+ mandatory breaths, only.

setting are phased in at the start of exhalation. Setting f and T

automatically determines the

. See Section 10.15.13, Inspiratory Time, page 235

for an explanation of the interdependencies

10.15.15 I:E Ratio

The I:E ratio setting is available when I:E is selected as the constant during rate change. The I:E setting determines the ratio of inspiratory time to expiratory time for mandatory PC breaths. The ventilator accepts the specified range of direct I:E ratio settings as long as the resulting T

and T

settings are within the ranges established for mandatory breaths. Changes to the I:E ratio phase in at the start of inspiration. Directly setting the I:E ratio in VC

mandatory breaths is not allowed. See Section 10.15.13, Inspiratory Time, page 235

for an explanation of the interdependencies of f, T

, T

, and I:E.

Setting f and I:E automatically determine the values for T

and T

. The maximum I:E ratio setting of 4.00:1 is the maximum that allows adequate time for exhalation and is intended for inverse ratio pressure control ventilation.

10.15.16 High Pressure in BiLevel

The high pressure level (P

) setting is the pressure level entered by the operator for the inspiratory phase of the mandatory breath in BiLevel ventilation.

10.15.17 Low Pressure in BiLevel

The low pressure level (P

) setting is the pressure level entered by the operator for the expiratory phase of the mandatory breath in BiLevel ventilation.

10.15.18 High Time in BiLevel

The high time (T

) setting is the duration of time (in seconds) the ventilator maintains the set high pressure level in BiLevel ventilation.

235

10.15.19 Low Time in BiLevel

The low time (T

) setting is the duration of time (in seconds) the ventilator maintains the set low pressure level in

BiLevel ventilation.

10.15.20 T

Ratio in BiLevel

The ratio of T

to T

in BiLevel ventilation, similar to I:E ratio when ventilating a patient without BiLevel.

10.15.21 PEEP

This setting defines the positive end-expiratory pressure (PEEP), also called baseline airway pressure. PEEP is the positive pressure maintained in the patient circuit during exhalation. Changes to the PEEP setting are phased in at the start of exhalation.

The sum of:

• PEEP +7 cmH

• PEEP + P

+2 cmH

O (if PC is active)

• PEEP + P

SUPP

+2 cmH

O (if PS is in use) cannot exceed the ⤒ P

PEAK the settings for PEEP, P

limit. To increase the sum of pressures, first raise the ⤒ P

PEAK

, or P

SUPP

limit before increasing

If there is a loss of PEEP from occlusion, disconnect, Safety Valve Open, or loss of power conditions, PEEP is re-established (when the condition is corrected) by the ventilator delivering a PEEP restoration breath. The PEEP restoration breath is a 1.5 cmH

O pressure-supported breath with exhalation sensitivity of 25%, and rise time% of

50%. A PEEP restoration breath is also delivered at the conclusion of Vent Startup. After PEEP is restored, the ventilator resumes breath delivery at the current settings.

Note: PEEP restoration breath parameters are not user adjustable.

10.15.22 Pressure Support

The pressure support (P

SUPP

) setting determines the level of positive pressure above PEEP applied to the patient’s airway during a spontaneous breath. P breaths are allowed. The P

SUPP

is only available in SIMV, SPONT, and BiLevel, in which spontaneous

setting is maintained as long as the patient inspires, and patient demand determines the flow rate. Changes to the ⤒ P

SUPP

setting are phased in at the start of inspiration. The pressure support setting affects only spontaneous breaths.

The sum of PEEP + P

SUPP

⤒ P

PEAK

+2 cmH

O cannot exceed the ⤒ P

limit before increasing the settings for PEEP or P considered safe for the patient, a P maximum safe circuit pressure.

SUPP

PEAK

SUPP

limit. To increase the sum of pressures, first raise the

. Since the ⤒ P

setting that would cause a ↑ P

PEAK

limit is the highest pressure

alarm requires re-evaluating the

10.15.23 Volume Support

Volume support (V

T SUPP

Changes to the to the V

) is defined as the volume of gas delivered to the patient during spontaneous VS breaths.

T SUPP

setting are phased in at the start of inspiration.

10.15.24 % Supp in TC

In TC, the% Supp setting represents the amount of the imposed resistance of the artificial airway the TC breath type will eliminate by applying added pressure at the patient circuit wye. For example, if the % Supp setting is

100%, TC eliminates 100% of the extra work imposed the by the airway. At 50%, TC eliminates 50% of the added work from the airway. TC is also used with BiLevel, and is available during both P

and P

phases.

236

10.15.25 % Supp in PAV+™

In PAV+™, the % Supp setting represents the percentage of the total work of breathing provided (WOB) by the ventilator. Higher inspiratory demand yields greater support from the ventilator. The patient performs the remaining work. If the total WOB changes (resulting from a change to resistance or compliance) the percent support remains constant.

10.15.26 Rise Time%

The rise time% setting allows adjustment of the speed at which the inspiratory pressure reaches 95% of the target pressure. Rise time settings apply to PS (including a setting of 0 cmH

O), VS, PC, or VC+ breaths. The higher the value of rise time%, the more aggressive (and hence, the more rapid) the rise of inspiratory pressure to the target

(which equals PEEP + P

(or P

SUPP

)). The rise time% setting only appears when pressure-based breaths are available.

The range of rise time% is 1% to 100%. A setting of 50% takes approximately half the time to reach 95% of the target pressure as a setting of 1.

• For mandatory PC, VC+, or BiLevel breaths, a rise time setting of 1 produces a pressure trajectory reaching 95% of the inspiratory target pressure (PEEP + P

in 2 seconds or 2/3 of the T

, whichever is shortest.

• For spontaneous breaths (VS, or PS), a rise time setting of 1 produces a pressure trajectory reaching 95% of the inspiratory target (PEEP + P

SUPP

) in (0.4 × PBW-based T

TOO LONG × 2/3) seconds.

• When both PC and PS breaths are active, the slopes and thus the pressure trajectories can appear to be different. Changes to T

and P

cause PC pressure trajectories to change. Changes in rise time% are phased in at the start of inspiration.

• When P

SUPP

=0, the rise time% setting determines how quickly the ventilator drives circuit pressure to

PEEP +1.5 cmH

10.15.27 Expiratory Sensitivity

The expiratory sensitivity (E

SENS

) setting defines the percentage of the measured peak inspiratory flow at which the ventilator cycles from inspiration to exhalation in all spontaneous breath types. When inspiratory flow falls to the level defined by E

SENS

Changes to E

SENS

, exhalation begins. E

SENS

is a primary setting and is accessible from the GUI screen.

are phased in at the next patient-initiated spontaneous inspiration.

SENS

complements rise time%. Rise time% should be adjusted first to match the patient’s inspiratory drive, and then the E

SENS

setting should cause ventilator exhalation to occur at a point most appropriate for the patient. The higher the E

SENS

setting, the shorter the inspiratory time. Generally, the most appropriate E

SENS

is compatible with the patient’s condition, neither extending nor shortening the patient’s intrinsic inspiratory phase.

SENS

in a PAV+™ breath is expressed in L/min instead of percent.

10.15.28 Disconnect Sensitivity

Leak Sync disabled: Disconnect sensitivity (D

SENS

) is defined as the percentage of returned volume lost due to a leak, above which the ventilator declares a CIRCUIT DISCONNECT alarm. When D

SENS

is set to its lowest value

(20%) it has the highest sensitivity for detecting a leak or disconnect. Conversely, when D

SENS

is set to its highest value (95%), the ventilator is least sensitive to declaring a leak or disconnect, because greater than 95% of the returned volume must be lost before the alarm annunciates. During NIV, the D

SENS

value is automatically set to OFF, which means that returned volume loss is not considered and the alarm will not sound.

Leak Sync enabled: and vice versa.

SENS

is defined as the leak at PEEP value in L/min, above which the ventilator declares a

CIRCUIT DISCONNECT alarm. The lowest setting is most sensitive to detecting and declaring a circuit disconnect

To set D

SENS

with NIV interfaces when Leak Sync is enabled

1. After adjusting the patient settings, start ventilation.

2. Ensure that Leak Sync is Enabled.

237

3. With the NIV interface open to ambient (not connected to the patient), use the patient data leak value to quantify the leak in L/min.

4. Set the D

SENS

(in L/min) below the leak rate (in L/min).

5. Periodically assess the leak rate, especially with PEEP changes, and adjust the D

SENS

setting as needed.

6. Always use alternative methods of monitoring during NIV.

Note: If D

SENS

is set to OFF during NIV, the ventilator is still capable of declaring a CIRCUIT DISCONNECT alarm.

Note: D

SENS

cannot be turned OFF if Leak Sync is enabled.

Changes to D

SENS

are phased in at the start of inspiration.

See

Table 59 for acceptable compliance and resistance ranges.

10.15.29 High Spontaneous Inspiratory Time Limit

The high spontaneous inspiratory time limit setting ( transitions to exhalation. The default ⤒ T

I SPONT

⤒ T

I SPONT

) is available only in SIMV or SPONT modes during

NIV, and provides a means for setting a maximum inspiratory time after which the ventilator automatically

setting is based upon circuit type and PBW.

For pediatric/adult circuit types, the new patient default value is (1.99+ (0.02× PBW)) seconds

For neonatal circuit types, the new patient default value is ((1.00+ (0.10× PBW) seconds

The ↑ T

I SPONT

indicator appears on the primary display at the beginning of a ventilator-initiated exhalation and remains visible for as long as the ventilator truncates breaths in response to the ⤒ T indicator disappears when the patient’s inspiratory time returns to less than the phased in at the start of inspiration.

⤒ T

I SPONT

setting. The ↑ T

I SPONT

setting, or after 15 seconds has elapsed after the beginning of exhalation of the last truncated breath. Changes to ⤒ T

I SPONT

are

10.15.30 Humidification Type

The humidification type setting sets the type of humidification system (heated expiratory tube, non-heated expiratory tube, or heat-moisture exchanger (HME) used on the ventilator and can be changed during normal ventilation or short self test (SST). Changes in humidification type phase in at the start of inspiration.

SST calibrates spirometry partly based on the humidification type. Changing the humidification type without rerunning SST can affect the accuracy of spirometry and delivery.

The accuracy of the exhalation flow sensor varies depending on the water vapor content of the expiratory gas, which depends on the type of humidification system in use. Because the temperature and humidity of gas entering the exhalation filter differ based on the humidification type being used, spirometry calculations also differ according to humidification type. For optimum accuracy, rerun SST to change the humidification type.

10.15.31 Humidifier Volume

The dry, compressible volume in mL of the humidification chamber for the humidification type entered during

SST. Only applies if a humidifier is used.

10.16 Safety Net

While the ventilator is designed to be as safe and as reliable as possible, Covidien recognizes the potential for problems to arise during mechanical ventilation, either due to user error, patient-ventilator interactions, or because of problems with the ventilator itself. Safety Net is a broad term that includes strategies for handling problems that arise in the “patient-ventilator“ system (patient problems) as well as strategies to minimize the impact of system faults on patient safety. In these scenarios, The ventilator is designed to alarm and to provide the highest level of ventilation support possible. in case of ventilator malfunction. If the ventilator is not capable of ventilatory support, it opens the patient circuit and allows the patient to breathe from room air if able to do so (this emergency state is called safety valve open (SVO) . Safety mechanisms are designed to be verified periodically

238

10 or to have redundancy. The ventilator is designed to ensure that a single-point failure does not cause a safety hazard or affect its ability to annunciate a high-priority audible alarm.

10.16.1 User Error

The ventilator is designed to prevent the operator from implementing settings that are clearly inappropriate for the patient’s predicted body weight (PBW). Each setting has either soft bounds (can be overridden) or hard bounds (no override allowed) that alert the operator to the fact that the settings may be inappropriate for the patient. In the event that the patient is connected without any parameters being specified, the ventilator enters

Safety PCV, a safe mode of ventilation regardless of the circuit type in use (neonatal, pediatric, or adult) or patient’s

PBW. Safety PCV is entered after POST, if a patient connection is made prior to settings confirmation. Safety PCV uses new patient default settings with exceptions shown in

Table 54, page 239

Table 54.

Safety PCV Settings

Parameter

PBW mode

Mandatory type

PEEP

Trigger type

Neonatal: 3 kg

Pediatric: 15 kg

Adult: 50 kg

A/C

PC f

TOT

(total respiratory rate) Neonatal: 25 1/min

Pediatric: 16 1/min

Adult: 16 1/min

Neonatal: 0.3 second

Pediatric: 0.7 second

Adult: 1 second

15 cmH

Neonatal: 40%

Pediatric: 100%

Adult: 100%

3 cmH

Neonatal: ⩒ -Trig

Pediatric: P-Trig

Adult: P-Trig

Safety PCV Value

SENS

⩒

SENS

↑ P

PEAK

↑ ⩒

E TOT

alarm

↓ ⩒

E TOT

alarm

↑ V

alarm

↓ V

TE MAND

alarm

↓ V

TE SPONT

alarm

Circuit type

2 cmH

1.0 L/min

20 cmH

OFF

0.05 L/min

OFF

Last set value, or adult if none available

Humidification type Set value, or Non-heated Exp Tube if none available

Humidifier volume Last set value, or 480 mL if none available

Note: In Safety PCV, expiratory pauses are not allowed.

239

10.16.2 Patient Related Problems

In case of patient problems, the ventilator remains fully operative and annunciates the appropriate alarm. The detection, response, and priority of each patient-related alarm is determined by the actual patient problem. See

Section 6.5, Alarms, page 137

for a comprehensive description of the patient alarm system.

10.16.3 System Related Problems

The ventilator is designed to prevent system faults. Its modular design allows the breath delivery unit (BDU) to operate independently of the graphical user interface (GUI) and several modules of the breath delivery sub-system have redundancy that, if certain faults occur, provides for ventilatory support using settings that do not depend on the suspect hardware. System faults include the following:

• Hardware faults (those that originate inside the ventilator and affect its performance)

• Soft faults (faults momentarily introduced into the ventilator that interfere with normal operation

• Inadequate supply (AC power or external gas pressure)

• Patient circuit integrity (occluded or disconnected circuit)

10.16.4 Background Diagnostic System

The ventilator has an extensive system of continuous testing processes. If an error is detected in the background diagnostic system, the ventilator notifies the operator by posting an entry in the diagnostic log. If the ventilator experiences an anomaly which causes an unintended reset, the ventilator will recover from that reset and deliver a breath within 3 seconds without any operator intervention. After recovering from a reset, the ventilator uses the same settings that were in effect before the reset occurred.

The background test process compares monitored values of ventilator functions with expected values of ventilator sensors under normal conditions regardless of whether the ventilator is in Stand-By or is ventilating a patient. The ventilator will continue to ventilate the patient with the highest level of support possible, and may revert to one of the states described. See

Section 4.11, Ventilator Protection Strategies, page 116 .

Background tests include:

• Periodically initiated tests performed at intervals of a specific number of machine cycles. These tests check hardware components directly affecting breath delivery, safety mechanisms, and the GUI, and detect and correct corruption of control variable data.

• Boundary checks performed at every analog measurement. These checks verify measurement circuitry, including sensors.

Ventilation Assurance is a safety net feature invoked if the Background Diagnostics detect a problem with certain components in either the gas mix subsystem, the inspiratory subsystem, or the expiratory subsystem. Each subsystem has a Backup Ventilation strategy that allows ventilation to continue by bypassing the suspect components giving the operator time to replace the ventilator.

Mix BUV is invoked if the measured gas mix is significantly different from the set mix, if the accumulator pressure is out of range or if a fault is indicated in the mix PSOLs or flow sensors. During MIX BUV, the normal mix controller is bypassed and ventilation continues as set, except that the gas mix reverts to 100% Oxygen or Air, depending on where the fault indication was detected. Backup circuits then control the pressure in the accumulator to keep it in the proper range for the Inspiratory Module.

Inspiratory BUV is invoked if background diagnostics detect a problem in the inspiratory module (PSOL or flow

sensor signal out of range). In inspiratory BUV, ventilation continues with the settings listed in Table 55

240

Table 55.

Inspiratory Backup Ventilation Settings

Backup Ventilation parameter

PBW

Mode

Mandatory type f

PEEP

Trigger type

Gas flow

Previously used setting during vent startup

A/C

Setting

Neonatal: 25 1/min

Pediatric: 16 1/min

Adult: 16 1/min

Neonatal: 0.3 s

Pediatric: 0.7 s

Adult: 1 s

15 cmH

100% (21% if O

not available)

3 cmH

⩒ -Trig; 2 L/min (adult/pediatric), 1.5 L/min

Controlled by pressure in the mix accumulator

During inspiratory BUV, the delivery PSOL is disabled, but gas delivery is achieved via an inspiratory BUV solenoid valve, the gas flow being created by pressure in the mix accumulator.

Exhalation BUV is invoked if problems with the Exhalation Valve driver are detected. A backup analog circuit is enabled to control the exhalation valve though the more advanced control features (active exhalation valve control) are not functional.

Note: During Mix and Inspiratory BUV, gas supply to installed options is disabled.

Entry into BUV is logged in the alarm log and system diagnostic log, and the status display provides an indicator that the ventilator is in BUV and which subsystem is affected.

When in BUV, a high priority alarm is annunciated, and the GUI displays an alarm banner indicating BUV, blanks patient data, and a displays a pressure waveform.

If the ventilator cannot provide any degree of reliable ventilatory support and fault monitoring, then the ventilator alarms and enters the safety valve open (SVO) emergency state. During SVO, the ventilator de-energizes the safety, expiratory, and inspiratory valves, annunciates a high-priority alarm, and turns on the SVO indicator. During SVO, a patient can spontaneously inspire room air (if able to do so) and exhale. Check valves on the inspiratory and expiratory sides minimize rebreathing of exhaled gas during SVO. During SVO the ventilator:

• Displays the elapsed time without ventilatory support

• Does not display patient data (including waveforms)

• Does not detect patient circuit occlusion or disconnect conditions

Visible indicators on the ventilator’s GUI and status display illuminate when the ventilator is in the SVO state. Other safeguards built into the ventilator include a one-way valve (check valve) in the inspiratory pneumatic circuit allowing the patient to inhale through the safety valve (if able to do so) with limited resistance. This check valve also limits exhaled flow from entering the inspiratory limb to reduce the possibility of re-breathing exhaled CO gas.

10.17 Power On Self Test (POST)

Every time the ventilator is powered on or resets and at the beginning of Short Self Test (SST) and Extended Self

Test (EST) it performs Power On Self Test (POST). POST checks the integrity of the GUI and Breath Delivery

241

subsystems and communication channels without operator intervention and takes approximately 12 seconds to complete.

If POST detects a major fault, qualified service personnel must correct the problem and successfully pass EST. See the Puritan Bennett 980 Series Ventilator Service Manual for more details on POST.

10.18 Short Self Test (SST)

SST is a short (about 5 minutes) and simple sequence of tests that verifies proper operation of breath delivery hardware (including pressure and flow sensors, checks the patient circuit (including tubing, humidification device, and filters) for leaks, and measures the circuit compliance and resistance. SST also checks the resistance of the exhalation filter. SST, in normal mode, can only be performed at start up, prior to initiation of ventilation.

Covidien recommends running SST every 15 days, between patients, and when changing the patient circuit or its configuration (including changing circuit type, adding or removing in-line water traps, or using a different type

or style of patient circuit). See Section 3.9.1.2, SST Test Sequence, page 85

. The ventilator does not allow access to SST if it senses a patient is connected.

10.19 Extended Self Test (EST)

EST verifies the integrity of the ventilator’s subsystems using operator participation. EST requires a “gold standard” test circuit and a stopper to block the patient wye. All test resources, including the software code to run EST, exist in the ventilator. EST testing, excluding tests of optional equipment such as the compressor and extended battery) takes about 10 minutes. If the compressor is used as the air source for EST and optional equipment is tested, then

EST takes approximately 15 minutes. See Section 3.9.2, Extended Self Test (EST), page 88 .

Warning: Do not enter Service mode with a patient attached to the ventilator. Serious injury could result.

242

11 Specifications

11.1 Overview

This chapter contains the following specifications for the Puritan Bennett 980 Series Ventilator:

• Physical

• Electrical

• Interface

• Environmental

• Performance (Ranges, resolution, and accuracies for ventilator settings, alarm settings, and patient data)

• Regulatory Compliance

11.2 Measurement Uncertainty

Measurement uncertainties and the manner in which they are applied are listed in

Table 56 unless otherwise

noted:

Table 56.

Performance Verification Equipment Uncertainty

Flow

Measured Parameter

Pressure

Oxygen Concentration

Temperature

Atmospheric Pressure

Offset

0.1001 SLPM

0.121594 cmH

0.0168 %O

0.886041°C

1.76 cmH

Gain

2.7642 % reading

0.195756 % reading

0.0973 % reading

0.128726 % reading

During breath delivery performance verification for flow and pressure based measurements, the equipment inaccuracy is subtracted from the acceptance specification as follows:

• Net Acceptance Gain = Requirement Specification Gain – Measurement Uncertainty Gain

• Net Acceptance Offset = Requirement Specification Offset – Measurement Uncertainty Offset

• Acceptance Limit = ± [(Net Acceptance Offset) + (Net Acceptance Gain) × (Setting)]

• (Setting – Acceptance Limit) ≤ Measurement ≤ (Setting + Acceptance Limit)

For derived parameters, such as volume, compliance, etc., the individual sensor uncertainties are combined and applied as applicable to determine the acceptance limits.

11.3 Physical Characteristics

Table 57.

Physical Characteristics

Weight

Dimensions

Ventilator: 113 lb (51.26 kg) including BDU, GUI, standard base, and pri‐ mary battery

BDU only: 69 lb (31.3 kg)

Ventilator and compressor: 71.2 kg1 (57 lb) including BDU, GUI, ventilator and compressor primary batteries, base assembly, and compressor

Compressor: 40.4 kg (89 lb) including base assembly

BDU only: 31.3 kg (69 lb)

Ventilator: 12.5 in. width by 11.5 in. depth by 43.5 in. height (32 cm by

30 cm by 111 cm) (not including GUI screen)

243

Table 57.

Physical Characteristics (continued)

Ventilator: 12.5 in. width by 11.5 in. depth by 58 in. height (32 cm by 30 cm by 148 cm) (including GUI screen)

Standard base: 22.5in.width by 26in. depth (58 cm by 66 cm)

At a distance of 1 meter does not exceed 48 dBA at 5 L/min A-weighted sound pressure level, ventilator (average)

A-weighted sound pressure level, ventilator and compressor

At a distance of 1 meter does not exceed 54 dBA at 5 L/min

A-weighted sound power level, ventilator

A-weighted sound power level, ventilator and compressor

Connectors

Does not exceed 58 dBA below 500 mL/min

Does not exceed 63 dBA below 500 mL/min

Inspiratory/ exhalation filters

Inspiratory and expiratory limb connectors are 22 mm OD conical fittings compliant with ISO 5356-1

Refer to filter IFU for complete specifications

Pressure units (chosen by operator) Hectopascal (hPa) centimeters of water (cmH

Displayed weight units Kilograms (kg) Pounds (lb)

Displayed length units Centimeters (cm) Inches (in)

Table 58.

Pneumatic Specifications

Oxygen and air inlet sup‐ plies

Oxygen sensor life

Gas mixing system

Pressure: 241 kPa to 600 kPa (35 psi to 87 psi)

Flow: Maximum of 200 L/min

Up to 1 year. Operating life varies depending on oxygen usage and ambient tem‐ perature.

Range of flow from the mixing system:

Up to 150 L/min for Adult patients. Additional flow is available (peak flow to

200 L/min) for compliance compensation

Up to 80 L/min for pediatric circuit type

Up to 30 L/min for neonatal circuit type

Leakage from one gas system to another: Meets IEC 80601-2-12 standard

Operating pressure range: 35 psi to 87 psi (241 to 600 kPa)

Table 59.

Technical Specifications

Maximum limited pressure (PLIM max)

Maximum working pressure (P)

W max

Response time to change in FiO

2 to 90% O

setting from 21% O

(measured at the patient wye)

Measuring and display devices

A fixed pressure limit to the safety valve limits circuit pressure to <123 hPa (125 cmH

O) at the patient wye.

W max

is ensured by the high pressure limit ( ⤒ P

PEAK when PI is <100 cmH

O (98.07 hPa)

)

<18 s for volumes >150 mL

<19 s for volumes ≥30 mL but ≤150 mL

<50 s for volumes ≥2 mL but <30 mL

Pressure measurements:

Type: Solid state differential pressure transducer

Sensing position: Inspiratory module; expiratory mod‐ ule

Mean circuit pressure (P

MEAN

–20 cmH

O (–20 hPa) to 100 cmH

O (98 hPa)

244

Table 59.

Technical Specifications (continued)

Peak circuit pressure (P

PEAK

: –20 cmH

O (–20 hPa) to

130 cmH

O (127 hPa)

Volume measurements:

Type: Hot film anemometer

Sensing position: Inspiratory module; expiratory mod‐ ule

Oxygen measurement:

Type: Galvanic cell

Sensing position: Inspiratory module

Minute volume ( ⩒

E TOT

) capability, ventilator

) capability, compressor

Up to 75 L/min

Up to 40 L/min BTPS, including compliance compen‐ sation

Results of ventilator testing using circuits identified for use with the ventilator system

Internal Inspiratory filter bacterial/viral filtration effi‐ ciency

>99.999%

Internal Inspiratory filter particle filtration efficiency >99.97% retention of particles 0.3 µm nominal at

100 L/min flow

Internal Inspiratory filter resistance

Combined inspiratory limb resistance

0.2 cmH

O < resistance < 2.2 cmH

0.2 cmH

O < resistance < 1.7 cmH

O at 30 L/min flow

O at 15 L/min flow

0.2 cmH

O < resistance < 5.5 cmH

0.2 cmH

O < resistance < 1.7 cmH

O at 30 LL/min flow

O at 15 L/min flow

Exhalation filter particle filtration efficiency, reusable > 99.97% retention of particles 0.3 mm nominal at

100 L/min flow

Exhalation filter bacterial/viral filtration efficiency, reus‐ able

Exhalation filter resistance (pediatric/adult, reusable and disposable)

Exhalation filter bacterial/viral filtration efficiency, dis‐ posable

> 99.999%

< 2.0 cmH

< 1.7 cmH

O at 30 L/min when new

O at 15 L/min when new

> 99.999%

Exhalation filter particle filtration efficiency, disposable >99.97% retention of particles 0.3 mm nominal at

100 L/min flow

Exhalation filter resistance, disposable

Exhalation filter particle filtration efficiency

<2.5 cmH

> 99.999%

O at 100 L/min when new

>99.97% retention of particles 0.3 µm nominal at

100 L/min flow

Exhalation filter bacterial/viral filtration efficiency,

(neonatal, disposable)

Exhalation filter particle filtration efficiency (neonatal, disposable)

Exhalation filter resistance (neonatal, disposable)

Circuit compliance (acceptable ranges of VBS compli‐ ance for each patient type)

Inspiratory limb circuit resistance (acceptable ranges of

VBS inspiratory limb circuit resistance for each patient type)

> 99.70% retention of particles 0.3 µm nominal at

30 L/min flow

<0.58 cmH

O at 2.5 L/min

ADULT: 1.3 mL/cmH

O to 4.2 mL/cmH

PEDIATRIC: 0.9 mL/cmH

O to 3.0 mL/cmH

NEONATAL: 0.4 mL/cmH

O to 1.5 mL/cmH

ADULT (at 60 L/min): 1.15 cmH

O to 11.0 cmH

PEDIATRIC (at 30 L/min): 0.46 cmH

NEONATAL (at 10 L/min): 0.37 cmH

(6.0 cmH

O for Prox)

O to 4.5 cmH

245

Table 59.

Technical Specifications (continued)

Expiratory limb circuit resistance (acceptable ranges of

VBS expiratory limb circuit resistance for each patient type)

Audio alarm volume (primary) Measurement uncer‐ tainty: ±3 dBA

Audio alarm volume (secondary) Measurement uncer‐ tainty: ±3 dBA

ADULT (at 60 L/min): 1.15 cmH

O to 11.0 cmH

PEDIATRIC (at 30 L/min): 0.46 cmH

NEONATAL (at 10 L/min): 0.37 cmH

(6.0 cmH

O for Prox)

O to 4.5 cmH

Range: High priority alarm volume range (dBA): 58 (vol‐ ume setting 1) to 86 (volume setting 10)

Medium priority alarm volume range (dBA): 52 (volume setting 1) to 78 (volume setting 10)

Low priority alarm volume range (dBA): 50 (volume setting 1) to 76 (volume setting 10)

Measured 1 m from front, rear, and sides of ventilator

See

Section 6.5.4, Alarm Volume Key, page 140

for alarm volume behavior during an alarm condition.

Resolution: 1

Minimum 64 dBA measured 1 m from front, rear, and sides of ventilator.

11.4 Electrical Specifications

Table 60.

Electrical Specifications

Electrical ratings, ventilator

Electrical ratings, ventilator and compressor

Mains overcurrent release

Earth leakage current

Touch current

Patient Leakage current

100 V ~, 50–60 Hz, 2.25 A

120 V ~, 50–60 Hz, 1.5 A

220–240 V~, 50–60 Hz, 0.75 A

100V~, 50-60 Hz, 8.25 A

120V~, 50-60 Hz, 6.0 A

220-240V~, 50-60 Hz, 3.0 A

Ventilator: 4 A

Compressor: 6 A

Meets requirements of IEC 60601-1, type BF applied part

Meets requirements of IEC 60601- 1, type BF applied part

11.5 Interface Requirements

The pin-out for the RS-232 interface is as follows:

Table 61.

Interface Pin Designations

Pin

Signal

N/C

RxD

TxD

N/C

GND

N/C

RTS

246

Not connected

Name

Receive data

Transmit data

Not connected

Ground

Not connected

Request to send

Table 61.

Interface Pin Designations (continued)

Pin

Signal

CTS

N/C

Clear to send

Not connected

Name

The pin-out for the nurse call interface is as listed in

Table 62, page 247

Table 62.

Nurse Call Pin Designations

Pin

Normally closed (NC)

Relay common

Normally open (NO)

Not connected

Configuration

11.6 Environmental Specifications

Table 63 provides the environmental conditions appropriate for using the ventilator. Use the ventilator only in

these specified conditions:

Table 63.

Environmental Specifications

Specification

Temperature

Operation

10°C to 40°C (50°F to 104°F) Ventilator

10°C to 35°C (50°F to 95°F) Internal Battery

Charger

Storage

–20°C to 70°C (–4°F to 158°F)

70 kPa to 106 kPa (10.15 psi to (15.37 psi) 50 kPa to 106 kPa (7.25 psi to 15.37 psi) Atmospheric pres‐ sure

Altitude –411.5 m to 3048 m (–1350 ft to 10 000 ft) 6096 m max (20 000 ft max)

Relative humidity 10% to 95% non-condensing 10% to 95% non-condensing

Note: When using the compressor, reduced dryer performance may be expected if relative humidity exceeds 50% when temperature is 40°C.

When using the compressor, reduced dryer performance may be expected if temperature exceeds 32.8°C when relative humidity is 95%.

Note: The limits marked on the device label represent out-of-box storage conditions as follows:

• Temperature: (10°C to 40°C (50°F to 104°F)

• Pressure: 70 kPa to 106 kPa (10.15 psi to 15.37 psi)

• Relative Humidity: 10% to 95% non-condensing

11.7 Performance Specifications

11.7.1 Ranges and Resolutions

See

Table 64 for ranges and resolutions for ventilator settings,

Table 65

for alarm settings, and Table 66, page 256 for

displayed patient data parameters.

Table 64.

Ventilator Settings Range and Resolution

Setting

Apnea ventilation

Description

A safety mode of ventilation that starts if the patient does not receive

Range and resolution

See individual apnea settings.

247

Table 64.

Ventilator Settings Range and Resolution (continued)

Setting

Apnea expiratory time (T

Apnea I:E ratio

)

Description a breath for an elapsed time exceed‐ ing the apnea interval.

For mandatory PC apnea breaths, the time interval between the end of inspiration and the beginning of the next inspiration.

In PC breath types, specifies the ratio of apnea inspiratory time to apnea expiratory time.

Range and resolution

Range: 0.20 s to 59.8 s

Resolution: 0.01 s

Sets the number of volume- or pres‐ sure-based breaths per minute for ventilator initiated mandatory (VIM) apnea breaths.

Sets the volume of gas delivered to the patient’s lungs during a manda‐ tory, volume-controlled apnea breath. Apnea tidal volume is com‐ pensated for body temperature and pressure, saturated (BTPS) and the compliance of the patient circuit.

Range: I:E ≤ 1.00:1

Resolution:

0.01 for values >1:10.0;

0.1 for values ≤1:10 and >1:100;

1 for values ≤1:100

Range: SQUARE, descending ramp Apnea flow pattern

Apnea inspiratory pressure (P

Apnea inspiratory time (T

)

Apnea interval (T

Apnea O

) The time after which the ventilator transitions to apnea ventilation

≥60/f

Determines the oxygen concentra‐ tion in a standard mixture of air and oxygen.

Apnea peak inspiratory flow ( ⩒

MAX

) The maximum rate of tidal volume delivery during mandatory volumebased apnea breaths.

Range: 0.20 s to 8 s

Resolution:

0.01 s in PC or VC+, 0.02 s in VC

Range: 3 s to 60 s or OFF in CPAP

Resolution: 1 s

Range: 21% O

Resolution: 1%

to 100% O2

Apnea respiratory rate (f

Apnea tidal volume (V

)

The flow shape of the delivered mandatory volume-based (VC) apnea breath.

The pressure above PEEP at which gas is delivered to the patient dur‐ ing mandatory PC apnea breaths.

Same as inspiratory time for nonap‐ nea ventilation.

Range: 5 cmH

O to 90–PEEP cmH

Resolution: 1 cmH

Range: When mandatory type is VC:

NEONATAL: 1 L/min to 30 L/min

PEDIATRIC: 3.0 L/min to 60 L/min

ADULT: 3.0 L/min to 150 L/min

Resolution:

0.1 L/min for flows

<20 L/min (BTPS);

1 L/min for flows ≥20 L/min (BTPS)

Range: 2.0 1/min to 40 1/min

Resolution:

0.1 1/min for 2.0 1/min to 9.9 1/min;

1 1/min for 10 1/min to 40 1/min

Range:

NEONATAL: 3 mL to 315 mL

PEDIATRIC/ADULT:

≥25 mL to 2500 mL

Resolution: 0.1 mL for values

<20 mL;

0.5 mL for values ≥20 mL and

<25 mL;

248

Table 64.

Ventilator Settings Range and Resolution (continued)

Setting Description

Apnea constant during rate change Specifies which of the three opera‐ tor- adjustable breath timing varia‐ bles remains constant when respi‐ ratory rate is changed during apnea ventilation.

Apnea mandatory type The type of mandatory breath deliv‐ ered during apnea ventilation.

Circuit type

Constant during rate change

Specifies the circuit for which com‐ pliance and resistance values dur‐ ing SST have been calculated.

Specifies which of the three opera‐ tor- adjustable breath timing varia‐ bles remains constant when respi‐ ratory rate is changed.

Disconnect sensitivity

SENS

)

Leak Sync disabled: The percent‐ age of returned volume lost, above which the ventilator declares a cir‐ cuit disconnect alarm.

Leak Sync enabled: The leak at

PEEP value in L/min, above which the ventilator declares a CIRCUIT

DISCONNECT alarm.

Range and resolution

1 mL for values ≥25 mL and

<100 mL; 5

mL for values ≥100 mL and

<400 mL;

10 mL for values ≥400 mL

Range: T

Range: PC, VC

Range: NEONATAL, PEDIATRIC,

ADULT

Range: I:E ratio, T

I breaths; T

, T

ratio, T

for PC or VC+

in BiLevel

Expiratory sensitivity

SENS

)

Expiratory time (T

)

The percentage of ⩒

MAX

that, when reached, causes the ventilator to cycle from inspiration to exhalation during spontaneous, pressurebased breaths.

For PC or VC+ breaths, the time interval between the end of inspi‐ ration and the beginning of the next inspiration. The end of the expira‐

Range (Leak Sync disabled): 20% to

95% or OFF

Range (Leak Sync enabled):

NEONATAL:

Invasive: 1 L/min to 15 L/min

NIV: 1 L/min to 30 L/min

PEDIATRIC: 1 L/min to 40 L/min

ADULT: 1 L/min to 65 L/min

Resolution (Leak Sync disabled): 1%

Resolution (Leak Sync enabled):

0.5 L/min for values <10 L/min;

1 L/min for values ≥10 L/min

Range: 1% to 80% when Spontane‐ ous Type is PS, or VS

1 L/min to 10 L/min when Sponta‐ neous Type is PAV+™.

Resolution:1% when spontaneous type is PS, TC, or VS; 1 L/min when spontaneous type is PAV+™.

Note: Default value is not expected to need adjustment. Only adjust after becoming experienced with

PAV+™ and only if it is suspected that the ventilator is not cycling at the patient’s end-of-inspiration.

Range: ≥0.20 s

Resolution: 0.01 s

249

Table 64.

Ventilator Settings Range and Resolution (continued)

Flow pattern

Gender

Height

Setting

Flow sensitivity ( ⩒

SENS

)

Description tory phase is considered to be when the flow rate at the patient wye remains less than 0.5 L/min above the base flow.

The flow shape of the delivered mandatory or VC breath

For flow triggered breaths, deter‐ mines the volume of flow (below the base flow) required to begin a mandatory or spontaneous patient initiated breath.

The patient’s gender

The patient’s height

High spontaneous inspiratory time limit ( ⤒

Humidification type

Humidifier volume

Elevate O

I:E ratio

I SPONT

)

Inspiratory pressure (P

)

Active in NIV only, allows the oper‐ ator to select the maximum spon‐ taneous inspiratory time.

The type of humidification system used on the ventilator

The empty fluid volume of the cur‐ rently installed humidifier.

The percentage of O to the current air/O minutes

to be added

mixture for 2

In PC and VC+ breath types, speci‐ fies the ratio of inspiratory time to expiratory time.

The pressure above PEEP at which gas is delivered to the patient dur‐ ing mandatory PC breaths.

Range and resolution

Range: SQUARE, descending ramp

Range:

NEONATAL: 0.1 L/min to 10 L/min

PEDIATRIC/ADULT: 0.2 L/min to

20.0 L/min

Resolution: 0.1 L/min

Range: Male or Female

Range:

19.5 cm to 280 cm; 7.5 in. to 110 in.

Resolution:

0.5 cm for heights <35 cm;

1 cm for heights <254 cm;

2 cm for heights ≥254 cm;

0.25 in. for heights <14 in.; 0.5 in. for heights <100 in.;

1 in. for heights ≥100 in.

See Section 4.6, Predicted Body

Weight (PBW) Calculation, page 106 .

Range:

NEONATAL: 0.2 s to 1.7 s

PEDIATRIC/ADULT: 0.4 s to 5 s

Resolution: 0.1 s

Range: HME, non-heated expiratory tube, heated expiratory tube

Range: 100 mL to 1000 mL

Resolution: 10 mL

Range: 1% to 100%

Resolution: 1% between 1% and

10%; 5% between 5% and 75%; jumps to 100% when increased above 75%

Range: 1:299 to 149:1

Resolution: 0.01 for values >1:10; 0.1

for values ≤1:10.0 and >1:100.0;

1 for values ≤1:100

Displayed as XX:1 when I:E ≥1; dis‐ played as 1:XX when I:E <1

Range: 5 cmH

O to 90 cmH

Resolution: 1 cmH

250

Table 64.

Ventilator Settings Range and Resolution (continued)

Setting

Inspiratory time (T

)

Leak Sync (leak compensation)

Mandatory type mL/kg ratio

Mode

% (delivered)

Peak inspiratory flow ( ⩒

MAX

)

Description

The time during which an inspira‐ tion is delivered to the patient dur‐ ing mandatory PC or VC+ breaths.

Compensates for leaks during inva‐ sive or non-invasive (NIV) ventila‐ tion.

The type of mandatory breath deliv‐ ered in A/C, SPONT or SIMV modes.

SPONT mode allows mandatory type selection for operator initiated mandatory (OIM) breaths.

The default tidal volume/PBW ratio

(only adjustable in Service Mode)

The ventilation mode. The mode determines the allowable breath types:

A/C—assist/control—a mandatory mode allowing volume controlled

(VC), pressure controlled (PC), or

VC+ breath types.

SPONT—allows the patient to ini‐ tiate the breath. Applicable SPONT breath types are pressure support

(PS), volume support (VS), tube compensated (TC) or PAV+.

SIMV—Synchronized Intermittent

Mandatory Ventilation—a mixed ventilatory mode providing manda‐ tory breaths and allowing a patient spontaneous breaths during the breath cycle. BiLevel—a mixed ven‐ tilatory mode combining the attrib‐ utes of both mandatory and spon‐ taneous breaths incorporating two pressure levels, P

and P

Percentage of delivered oxygen in the gas mixture

The maximum rate of tidal volume delivery during mandatory volumebased breaths.

Range and resolution

Range: 0.2 s to 8 s for mandatory PC, and VC+ breaths

+0.2 s to 8 s in VC

Resolution: 0.01 s for PC or VC+ breaths; 0.02 s for VC breaths

Range: Enabled or Disabled

Range: PC, VC, VC+

Range: 4.0 mL/kg to 10 mL/kg

Resolution: 0.5 mL/kg

Range: A/C, SPONT, SIMV, BiLevel but not available when ventilation type is NIV; CPAP (only available when circuit type is NEONATAL and ventilation type is NIV)

Range: 21% to 100%

Resolution: 1%

Range: When mandatory type is VC:

NEONATAL: 1 L/min to 30 L/min

PEDIATRIC: 3.0 L/min to 60 L/min

ADULT: 3.0 L/min to 150 L/min

Resolution:

0.1 L/min for values <20 L/min

(BTPS);

1 L/min for values ≥20 L/min (BTPS)

251

Table 64.

Ventilator Settings Range and Resolution (continued)

PEEP

Setting Description

Sets the positive end-expiratory pressure, defined as the pressure targeted in the patient circuit dur‐ ing exhalation.

The positive pressure during the insufflation phase in BiLevel venti‐ lation.

The positive pressure in the patient circuit during the expiratory phase of BiLevel ventilation.

Plateau time (T

Predicted Body Weight (PBW)

Pressure sensitivity (P

Pressure support (P

Respiratory rate (f )

Rise time%

)

SENS

SUPP

)

) or PS

For pressure triggered breaths, determines the amount of pressure below PEEP required to begin a mandatory or spontaneous patient initiated breath.

The positive pressure above PEEP

(or P

in BiLevel) during a spontane‐ ous breath.

Sets the number of volume- or pres‐ sure-based breaths per minute for ventilator initiated mandatory (VIM) breaths in A/C, SIMV, and BiLevel modes

Sets the speed at which inspiratory gas delivered to the patient reaches the pressure target in BiLevel, PC,

VC+, VS, or PS. Higher percentages of rise time produce inspiratory

Range and resolution

Range: 0 cmH

O to 45 cmH

Resolution: 0.5 cmH

0.0 cmH

O from

O to 19.5 cmH

O; 1 cmH from 20 cmH

O to 45 cmH

Range: 5 cmH

O to 90 cmH

Resolution: 1 cmH

The amount of time inspiration is held in the patient’s lungs after inspiratory flow ceases for manda‐ tory volume-based breaths. Consid‐ ered part of the inspiratory phase for

I:E ratio calculations.

Indicates an approximation of the patient’s body weight based upon their gender and height (or length for neonatal patients). PBW deter‐ mines default limits and limits for breath delivery parameters.

Range: 0 cmH

O to 45 cmH

Resolution:

0.5 cmH

O from 0.0 cmH

19.5 cmH

O; 1 cmH

20 cmH

2 2

O to

O from

O to 45 cmH

Range: 0 s to 2 s

Resolution: 0.1 s

Range:

NEONATAL: 0.3 kg (0.66 lb) to 7.0 kg

(15 lb) when NeoMode 2.0 option is installed;

PEDIATRIC: 3.5 kg (7.7 lb) to 35 kg (77 lb)

ADULT: ≥25 kg (55.12 lb)

Resolution: 0.01 kg for weights

<1 kg, 0.1 kg for weights ≥1 kg and

<10 kg, 1 kg for weights ≥10 kg

Range: 0.1 cmH

O to 20.0 cmH

Resolution: 0.1 cmH

Range: 0 cmH

Resolution: 1 cmH

Range:

O to 70 cmH

NEONATAL: 1.0 1/min to 150 1/min

PEDIATRIC/ADULT: 1.0 1/min to 100

1/min

Resolution: 0.1 1/min from 1.0

1/min to 9.9 1/min; 1 1/min from 10

1/min to 150 1/min

Range: 1% to 100%

Resolution: 1%

252

Table 64.

Ventilator Settings Range and Resolution (continued)

% Supp

(time high)

(time low)

ratio

Setting

Spontaneous type

Description pressure trajectories with shorter time to the target value.

The breath type for patient initiated spontaneous breaths in SIMV,

SPONT, and BiLevel modes.

In tube compensation, specifies the additional positive pressure desired to overcome resistance of the artifi‐ cial airway.

In PAV+, specifies the percentage of total inspiratory work of breathing

(WOB) performed by the ventilator.

The duration of the insufflation phase during BiLevel ventilation.

The duration of the expiratory phase during BiLevel ventilation.

In BiLevel, specifies the ratio of insuf‐ flation time to expiratory time

Tidal volume (V

)

Volume support (V

Trigger type

Tube ID

T SUPP

) or VS

Range and resolution

Range: PS, TC, PAV+, or VS

Range: 10% to 100%

Resolution: 5%

Range: 5% to 95%

Resolution: 5%

The volume of gas delivered to the patient during a mandatory vol‐ ume-based breath. V

T saturated (BTPS) and circuit compli‐ ance. Applicable for volume-based breaths.

compensates for body temperature and pressure,

The volume of gas delivered to the patient during spontaneous, vol‐ ume supported breaths

Determines whether flow changes

( ⩒ -Trig, or pressure changes (P-Trig) trigger patient breaths

The internal diameter of the artificial airway used to ventilate the patient.

Range: 0.2 s to 30 s

Resolution: 0.01 s

Range: ≥0.20 s

Resolution: 0.01 s

Range: 1:299 to 4:1; in BiLevel T

Resolution: 0.01 for <10.00:1 and

>1:10.00; 0.1 for [<100.0:1 and

≥10.0:1] or[≤1:10.0 and >1:100.0]; 1 for <1:100.0 or ≥100:1

Range:

NEONATAL: 2 mL to 315 mL in VC+

NEONATAL: 3 mL to 315 mL in VC

PEDIATRIC: 25 mL to 1590 mL

ADULT: 25 mL to 2500 mL

Resolution: 0.1 mL for values

<20 mL; 0.5 mL for values ≥20 mL and <25 mL; 1 mL for values ≥25 mL and <100 mL; 5 mL for values

≥100 mL and <400 mL; 10 mL for values ≥400 mL

Range:

NEONATAL: 2 mL to 310 mL

PEDIATRIC: 25 mL to 1590 mL

ADULT: 25 mL to 2500 mL

Resolution: 0.1 mL for values

<20 mL; 0.5 mL for values ≥20 mL and <25 mL; 1 mL for values ≥25 mL and <100 mL; 5 mL for values

≥100 mL and <400 mL; 10 mL for values ≥400 mL

Range:

NEONATAL: ⩒ -Trig

PEDIATRIC/ADULT: ⩒ -Trig or P-Trig

Range: 4.5 mm to 10 mm when spontaneous type is TC

253

Table 64.

Ventilator Settings Range and Resolution (continued)

Tube type

Setting

Ventilation type

Description

The type of artificial airway used to ventilate the patient.

Invasive or non-invasive (NIV) ven‐ tilation type based upon the type of breathing interface used. Invasive:

ET or Trach tubes NIV: masks, infant nasal prongs, or uncuffed ET tubes

Range and resolution

Range: 6 mm to 10 mm when spon‐ taneous type is PAV+

Resolution: 0.5 mm

Range: Endotracheal (ET), tracheal

(Trach)

Range: Invasive, NIV

Table 65.

Alarm Settings Range and Resolution

Alarm volume setting ( ⤒ V

)

Setting

Apnea interval (T

) The apnea alarm condition indi‐ cates that neither the ventilator nor the patient has triggered a breath for the operator-selected apnea interval (T

). When the apnea alarm condition is true, the ventilator invokes mandatory ventilation as specified by the operator.

(

High circuit pressure setting

⤒ P

PEAK

)

The ↑ P

PEAK alarm level.

alarm indicates the patient’s airway pressure ≥ the set

Low circuit pressure setting ( ⤓ P

PEAK

) The ↓ P

PEAK

alarm indicates the measured airway pressure ≤ the set alarm limit during an NIV or VC+ inspiration.

High exhaled minute volume alarm setting ( ⤒⩒

E TOT

)

High exhaled tidal volume alarm

Controls the volume of alarm annunciations

The ↑ ⩒

E TOT

Description

alarm indicates the measured total minute volume

≥ the set alarm limit.

The ↑ V

alarm indicates that the measured exhaled tidal volume

Range and resolution

Range: 1 (minimum) to 10 (maxi‐ mum)

Resolution: 1

Range: 3 s to 60 s or OFF in CPAP

Resolution: 1 s

Range: 7 cmH

O to 100 cmH

Resolution: 1 cmH

Range:

NIV: OFF or ≥0.5 cmH

<100 cmH

Resolution:

0.5 cmH

O to

O for values < 20.0 cmH

1 cmH

O for values ≥20 cmH

Range: OFF and

NEONATAL: 0.1 L/min to 10 L/min

PEDIATRIC:

0.1 L/min to 30 L/min

ADULT:

0.1 L/min to 100 L/min

Resolution:

0.005 L/min for values <0.50 L/min;

0.05 L/min for values ≥ 0.5 L/min to

<5.0 L/min;

0.5 L/min for values ≥5.0 L/min

Range: OFF and

NEONATAL: 5 mL to 500 mL PEDIA‐

TRIC: 25 mL to 1500 mL ADULT: 25 mL to 3000 mL

254

(

Table 65.

Alarm Settings Range and Resolution (continued)

Setting

High inspired tidal volume alarm limit ( ⤒ V

)

High respiratory rate alarm setting

⤒ f

TOT

)

High spontaneous inspiratory time limit ( ⤒ T

I SPONT

)

Low exhaled mandatory tidal vol‐ ume alarm setting ( ⤓ V

TE MAND

)

The ↑ V

TI alarm limit.

Description

≥ the set alarm limit for spontane‐ ous and mandatory breaths.

alarm indicates the deliv‐ ered volume of any breath ≥ the set

The limit.

↑ f

TOT

alarm indicates the meas‐ ured breath rate ≥ the set alarm

The ↑ T

I SPONT

indicator allows the operator to select the maximum spontaneous inspiratory time of an

NIV breath. No alarm is annunci‐ ated; only the symbol ⤒ T

I SPONT appears on the screen near the NIV indicator when inspiration time exceeds the setting. If ⤒ T

I SPONT

is exceeded, the ventilator transitions from inspiration to exhalation.

The ↓ V

TE MAND

alarm indicates the measured mandatory tidal volume

≤ the set alarm limit.

Range and resolution

Resolution:

1 mL for values < 100 mL; 5 mL for values ≥ 100 mL and < 400 mL;

10 mL for values ≥ 400 mL

Range: 6 mL to 6000 mL

Resolution: 1 mL for values < 100 mL;

5 mL for values ≥ 100 mL to < 400 mL;

10 mL for values ≥ 400 mL

Range: OFF or

NEONATAL: 10 1/min to 170 1/ min

PEDIATRIC/ADULT: 10 1/min to 110

1/min Resolution: 1 1/min

Range:

NEONATAL: 0.2 to ≤ the value of the

NIV inspiratory time limit trigger for the patient’s PBW and circuit type s

PEDIATRIC/ADULT: 0.4 s to ≤ the value of the NIV inspiratory time limit trigger for the patient’s PBW and cir‐ cuit type s

Resolution: 0.1 s

Low exhaled minute volume alarm setting ( ⤓⩒ )

E TOT

Low exhaled spontaneous tidal vol‐ ume alarm setting ( ⤓ V

TE SPONT

)

The ↓ V

E TOT

alarm indicates the measured exhaled minute volume

≤ the set alarm limit for mandatory and spontaneous breaths.

The ↓ V

TE SPONT

alarm indicates the measured spontaneous tidal vol‐ ume ≤ the set alarm limit.

Range: OFF and

NEONATAL: 1 mL to 300 mL PEDIA‐

TRIC: 1 mL to 1000 mL ADULT: 1 mL to

2500 mL

Resolution: 1.0 mL for values <

100 mL;

5 mL for values ≥ 100 mL and <

400 mL;

10 mL for values ≥ 400 mL

Range: OFF when ventilation type =

NIV and

NEONATAL: OFF, 0.01 L/min to

10 L/min

PEDIATRIC:

0.05 L/min to 30 L/min

ADULT:

0.05 L/min to 60 L/min

Resolution: 0.005 L/min for values <

0.50 L/min;

0.05 L/min for values ≥ 0.50 L/min and <5.0 L/min; 0.5 L/min for values

>5.0 L/min

Range: OFF and

NEONATAL: 1 mL to 300 mL PEDIA‐

TRIC: 1 to 1000 mL ADULT: 1 to

2500 mL

255

Table 65.

Alarm Settings Range and Resolution (continued)

Setting Description Range and resolution

Resolution: 1 mL for values < 100 mL;

5 mL from 100 mL to <400 mL; 10 mL for values ≥400 mL

Table 66.

Patient Data Range and Resolution

Data value

Breath phase

Inspired tidal volume (V

)

Description

The breath phase indicator displays the breath delivery phase (inspira‐ tion or exhalation) currently being delivered to the patient.

The volume inspired for a pressurebased breath.

Range and resolution

Range: Control (C), Assist (A), Sponta‐ neous (S)

Driving Pressure (P

DRIVE

Inspired tidal volume (V ing Leak Sync

Dynamic compliance (C

Dynamic resistance (R

)

DYN

End expiratory flow (EEF)

)

) dur‐

DYN

)

During PAV+™, P

DRIVE

is computed as the pressure difference between Pla‐ teau Pressure and the estimated

PEEP

TOT

The volume inspired for each breath when Leak Sync is enabled.

The result of dividing the delivered tidal volume by the peak airway pressure.

The change in pressure per unit change in flow.

The rate of expiratory flow occurring at the end of exhalation.

End expiratory pressure (PEEP) The pressure at the end of the expir‐ atory phase of the previous breath

(also applies in BiLevel).

Range: 0 mL to 6000 mL

Resolution:

0.1 mL for 0 mL to 9.9 mL; 1 mL for val‐ ues 10 mL to 6000 mL

Range: 0 cmH

O to 90 cmH

Resolution: 0.1 cmH

O for 0 cmH

O to

9.9 cmH

1.0 cmH

90 cmH

O for values 10 cmH

O to

Range: 0 mL to 6000 mL

Resolution:

1 mL for values <10 mL;

1 mL for values 10 mL to 6000 mL

Range: 0 mL/cmH

O to 200 mL/cmH

Resolution: 0.1 mL/cmH

10 mL/cmH

1 mL/cmH mL/cmH

O for values <

O for values ≥10

Range: 0.0 cmH

O/L/s to 100 cmH

O/L/s

Resolution:

0.1 cmH cmH

1 cmH cmH

O/L/s;

O/L/ for values < 10

O/L/s for values ≥ 10

O/L/s

Range: 0 to 150 L/min

Resolution:

0.1 L/min for values < 20 L/min 1 L/min for values ≥ 20 L/min

Range: -20.0 cmH

O to 130 cmH

Resolution:

0.5 cmH

O between -10.0 cmH and +10.0 cmH

≤–10 cmH

O; 1 cmH

O for values

O and ≥10 cmH

256

Table 66.

Patient Data Range and Resolution (continued)

)

Data value

End inspiratory pressure (P

I END

Description

) The pressure at the end of the inspir‐ atory phase of the current breath

(also applies in BiLevel).

Exhaled mandatory tidal vol‐ ume (V

TE MAND

)

The exhaled volume of the last man‐ datory breath. When the mode is

SPONT, and no mandatory breaths have occurred for a time period ≥ 2 minutes, the V

TE MAND

indicator is hidden. Mandatory breaths can occurs during SPONT mode via man‐ ual inspiration.

Exhaled minute volume ( ⩒

E TOT

) A calculated sum of the volumes exhaled by the patient for manda‐ tory and spontaneous breaths for the previous one-minute interval

(also applies in BiLevel).

Exhaled spontaneous minute volume (V

CO2

E SPONT

)

The sum of exhaled spontaneous volumes per minute (also applies in

BiLevel).

Exhaled spontaneous tidal vol‐ ume (V

TE SPONT

)

Exhaled tidal volume (V

)

Leak Sync exhaled tidal volume

The exhaled volume of the last spon‐ taneous breath.

The volume exhaled by the patient for the previous mandatory or spon‐ taneous breath (also applies in BiLe‐ vel).

The volume exhaled by the patient for the previous mandatory or spon‐ taneous breath during Leak Sync

(also applies in BiLevel).

I:E ratio

Intrinsic PEEP (PEEP

)

The ratio of the inspiratory time to expiratory time for the previous breath.

Inspiratory compliance (C

/C) the ratio of compliance of the last

20% of inspiration to the compliance of the entire inspiration.

A calculated estimate of the pressure above PEEP at the end of exhalation.

Range and resolution

Range: –20.0 cmH

Resolution:

0.1 cmH

O to 130 cmH

O for –20.0 cmH

O to

9.9 cmH

1.0 cmH

130 cmH

O for values 10 cmH

O to

Range: 0 mL to 6000 mL

Resolution:

0.1 mL for 0 mL to 9.9 mL;

1 mL for 10 mL to 6000 mL

Range: 0.00 L/min to 99.9 L/min Reso‐ lution: 0.01 L/min for 0.00 to 9.99 L/min;

0.1 L/min for 10.0 to 99.9 L/min

Range: 0 L/min to 99.9 L/min

Resolution:

0.01 L/min for 0.00 to 9.99 L/min;

0.1 L/min for 10.0 to 99.9 L/min

Range: 0 mL to 6000 mL Resolution:

0.1 mL for 0 mL to 9.9 mL; 1 mL for

10 mL to 6000 mL

Range: 0 mL to 6000 mL

Resolution:

0.1 mL for 0 mL to 9.9 mL;

1 mL for 10 mL to 6000 mL

Range: 0 mL to 6000 mL

Resolution:

0.1 mL for 0 mL to 9.9 mL;

1 mL for 10 mL to 6000 mL

Range: 1:599 to 149:1 Resolution: 0.1 for

9.9:1 to 1:9.9; 1 for 149:1 to 10:1 and 1:10 to 1:599

Range: 0 to 1.00

Resolution: 0.01

Range: -20.0 cmH

Resolution:

0.1 cmH

O to +130 cmH

O between -9.9

and +9.9 cmH

1 cmH

O ≤–10 cmH

≥ 10 cmH

O and

257

Table 66.

Patient Data Range and Resolution (continued)

Data value Description

Mean circuit pressure (P

MEAN

) The calculated average circuit pres‐ sure for an entire breath cycle includ‐ ing both inspiratory and expiratory phases (whether the breath is man‐ datory or spontaneous).

Negative inspiratory force (NIF) The negative pressure generated during a maximally forced inspira‐ tory effort against an obstruction to flow.

% (monitored) The monitored percentage of oxy‐ gen in the gas delivered to the patient, measured at the ventilator outlet upstream of the inspiratory filter.

0.1

The inspiratory depression of airway pressure after 100 of occlusion. P

0.1

measures respiratory drive.

PAV based intrinsic PEEP (PEEP

PAV

)

PAV-based lung compliance

PAV-based lung elastance (E

PAV-based patient resistance

PAV

)

a a

PAV

)

Range and resolution

Range: –20.0 cmH

Resolution:

0.1 cmH

1 cmH

Range: ≤0 cmH

O to ≥–50 cmH

Resolution: 1 cmH

≤ –10 cmH

> –10 cmH

O; 0.1 cmH

Range: 0% to 103%

Resolution: 1%

O to 100 cmH

O for 10 to 100 cmH

O for values

O for –20.0 to 9.9 cmH

O for values

The estimated intrinsic PEEP during a

PAV+™ breath. Intrinsic PEEP is an estimate of the pressure above PEEP at the end of every pause exhalation.

The calculated change in pulmonary volume for an applied change in patient airway pressure when meas‐ ured under conditions of zero flow during a PAV+™ plateau maneuver.

When PAV+™ is selected, the venti‐ lator displays the current filtered value for patient compliance, and updates the display at the successful completion of each estimation. C

PAV can be displayed in the vital patient data banner. See

Section 3.8.2.7, Vital

Patient Data, page 81

For a PAV+™ breath, E as the inverse of C

PAV

is calculated

(see above).

can be displayed in the vital

patient data banner. See Sec‐ tion 3.8.2.7, Vital Patient Data, page 81 .

The difference between estimated total resistance R

TOT

and the simul‐ taneously estimated resistance of the artificial airway. When PAV+™ is selected, the ventilator displays the current filtered value for patient resistance, and updates the display at the successful completion of each

Range: ≥–20 cmH

Resolution:

1 cmH

O when <–10 cmH

0.1 cmH

O to 0 cmH

O when ≥–10 cmH

Range: 0 cmH

O to 130 cmH

Resolution: 0.1 cmH

O for values

<10 cmH

1 cmH

O for values ≥10 cmH

Range: 2.5 mL/cmH

O to 200 mL/cmH

Resolution: 0.1 mL/cmH

O for values

<10 mL/cmH

1 cmH

O for values ≥10 mL/cmH

Range: 5.0 cmH

O/L to 400 cmH

Resolution: 0.1 cmH cmH

O/L;

O/L

O/L for values < 10

1 cmH

O/L ≥10 cmH

O/L

Range: 0.0 cmH

O/L/s to 60 cmH

O/L/s

Resolution: 0.1 cmH

O/L/s for values

<10 cmH

1cmH

O/L/s;

O/L/s for values ≥10 cmH

O/L/s

258

Table 66.

Patient Data Range and Resolution (continued) ance (R

TOT

Data value

PAV-based total airway resist‐

)

Description estimation. R

PAV

can be displayed in the vital patient data banner. See

Section 3.8.2.7, Vital Patient Data, page 81

TOT

is an estimated value captured just past peak expiratory flow and is equal to the pressure loss across the patient plus respiratory system

(patient + ET tube + expiratory limb of the VBS)/expiratory flow. This pressure loss is divided by the expir‐ atory flow estimated at the same moment, yielding the estimate for

TOT

.The complete operation is orch‐ estrated and monitored by a soft‐ ware algorithm. When PAV+™ is selected, the ventilator displays the current filtered value for total resist‐ ance, and updates the display at the successful completion of each cal‐ culation. R

TOT

can be displayed in the vital patient data banner. See

Sec‐ tion 3.8.2.7, Vital Patient Data, page 81 .

Range and resolution

Range: 1.0 cmH

2 cmH

O/L/s

Resolution: 0.1 cmH

<10 cmH

2 ues ≥10 cmH

O/L/s to 80

O/L/s

O/L/s for values

O/L/s; 1 cmH

O/L/s for val‐

PAV-based work of breathing

(WOB

TEY

)

TOT

Proximal exhaled tidal volume volume (

)

Peak expiratory flow (PEF)

The estimated effort needed for patient inspiration including both patient and ventilator.

Range: 1.0 J/L to10.0 J/L

Resolution: 0.1 J/L

The maximum speed of exhalation. Range:0 to 150 L/min

Resolution: 0.1 L/min for PEF

<20 L/min; 1 L/min for PEF ≥20 L/min

Peak circuit pressure (P

PEAK

) The maximum pressure during the previous breath, relative to the patient wye, including inspiratory and expiratory phases.

Peak spontaneous flow (PSF) The maximum flow rate sampled during a spontaneous inspiration.

Plateau pressure (P

)

Proximal exhaled total minute

⩒

E TOTY

)

The pressure measured during an inspiratory pause maneuver.

For neonatal patients, the exhaled volume of the previous breath meas‐ ured by the Proximal Flow Sensor (if installed).

For neonatal patients, the exhaled minute volume measured by the

Proximal Flow Sensor.

Range: –20.0 cmH

Resolution: 0.1 cmH to 9.9 cmH

10 cmH

Range: 0.00 to 99.9 L/min

Resolution: 0.01 L/min for 0.00 to

9.99 L/min; 0.1 L/min for 10.0 L/min to

99.9 L/min

O to 130 cmH for values ≥20 L/min

O for values –20.0

O; 1.0 cmH

O to 130 cmH

O for values

Range: 0 to 200 L/min Resolution:

0.1 L/min for values <20 L/min; 1 L/min

Range: –20.0 cmH

Resolution: 0.1 cmH

O to 130 cmH to 9.9 cmH

≥10 cmH

O; 1.0 cmH

O for values –20.0

O for values

Range: 0 mL to 500 mL Resolution:

0.1 mL for values 0 mL to 9.9 mL; 1 mL for values 10 mL to 500 mL

259

Table 66.

Patient Data Range and Resolution (continued)

Data value

Proximal inspired tidal volume

TIY

)

Spontaneous inspiratory time

I SPONT

)

Spontaneous inspiratory time ratio (T

TOT

)

Spontaneous rapid shallow breathing index (f/V

Static compliance (C

)

STAT

)

Description

For neonatal patients, the exhaled volume of the previous breath meas‐ ured by the Proximal Flow Sensor (if installed).

The duration of the inspiratory phase of a spontaneous breath.

The fraction of the total spontaneous breath time used by inspiration.

A calculated value using exhaled spontaneous tidal volume. High val‐ ues indicate the patient is breathing rapidly, but with little vol‐ ume/breath. Low values indicate the inverse scenario.

An estimate of the patient’s lungthorax static compliance or elasticity.

Resistance (R

STAT

Total PEEP (PEEP

)

Total respiratory rate (f

Vital capacity (VC)

LEAK

%LEAK

LEAK

TOT

)

Range: 0 s to 10 s

Resolution: 0.01 s

Range: 0 to 1

Resolution: 0.01

Range: 0.1 1/min-L to 600 1/min-L

Resolution: 0.1 1/min-L for values < 10

1/min-L; 1 1/min-L; for values ≥10

1/min-L

Range and resolution

Range: 0 mL to 500 mL

Resolution: 1 mL

An estimate of the restrictiveness of the patient’s lungs and the artificial airway.

The estimated pressure at the circuit wye during an expiratory pause maneuver.

The number of mandatory or spon‐ taneous breaths/min delivered to the patient.

The maximum amount of air that can be exhaled after a maximum inhala‐ tion.

Range: 0 mL/cmH

O to 500 mL/cmH

Resolution: 0.1 mL/cmH

<10 mL/; 1 mL/cmH mL/cmH

O for values

O for values ≥ 10

Range: 0 cmH

O/L/s to 500 cmH

Resolution: 0.1 cmH

O /L/s

O/L/s for values

<10 cmH

1 cmH

O/L/s;

O/L/s for values ≥10 cmH

O/L/s

Range: –20.0 cmH

Resolution: 0.1 cmH

<10 cmH

≤ –10 cmH

O to +130 cmH

O for values

O; 1 cmH

O for values

O and ≥ 10 cmH

Range: 1 1/min to 200 1/min

Resolution: 0.1 1/min for values <10

1/min; 1 1/min for 10 1/min to 200

1/min

Range: 0 mL to 6000 mL

Resolution:

0.1 mL for values <10 mL; 1 mL for val‐ ues ≥10 mL

Range: 0 mL to 9000 mL

Resolution: 1 mL

Inspiratory leak volume. The total volume delivered during inspiration to compensate for the leak.

Percent leak. The percentage of total delivered volume during inspiration attributed to the leak calculated as

(leak volume during inspiration / total delivered inspiratory volume) ×

100.

Exhalation leak. The leak rate at PEEP during exhalation.

Range: 0% to 100%

Resolution: 1%

Range: 0 L/min to 200 L/min

260

Table 66.

Patient Data Range and Resolution (continued)

Data value

LEAK

Description

Exhalation Leak at PEEP during Leak

Sync measured by the proximal flow sensor.

Range and resolution

Resolution: 0.1 L/min

Range: 0 L/min to 200 L/min

Resolution: 0.1 L/min a If the estimated value of C

PAV

, E

PAV

, R

PAV

, or R

TOT

violates expected (PBW-based) limits, parentheses around the value indicate the value is questionable. If the estimated value exceeds its absolute limit, the limit value flashes in parentheses.

Table 67.

Delivery Accuracy

Parameter

Inspiratory pressure (P

)

End expiratory pressure (PEEP)

Pressure support (P

SUPP

)

Tidal volume (V

)

% (delivered)

Accuracy

± (3.0+2.5% of setting) cmH

± (2.0+4% of setting) cmH

± (3.0+2.5% of setting) cmH

For adult and pediatric circuit type settings:

For T

<600 ms: ± (10 + 10% of set‐ ting × 600 ms/T

ms) mL

For T ≥600 ms ± (10 +10% of set‐ ting) mL

For neonatal circuit type settings:

For setting of 2 mL (VC+ only): ±

(1 +10% of setting) mL

For setting of 3 mL to 4 mL: ± (2 +

10% of setting) mL (delivered vol‐ ume shall be ≥1 mL

For setting of 5 mL to 20 mL ±

(3 +15% of setting)

For setting of ≥20 mL: ± (4+10% of setting) mL

±3%

± (2.0+4% of setting) cmH

5 cmH

O to 90 cmH

0 cmH

O to 45 cmH

0 cmH

O to 70 cmH

For adult and pediatric circuit type settings:

25 mL to 2500 mL

For neonatal circuit type settings:

2 mL to 310 mL

21% to 100%

Range

5 cmH

O to 90 cmH

0 cmH

O to 45 cmH

Table 68.

Monitoring (Patient Data) Accuracy

Parameter

Peak circuit pressure (P

PEAK

)

Mean circuit pressure (P

MEAN

)

End expiratory pressure (PEEP)

End inspiratory pressure (P

I END

)

Inspired tidal volume (V

)

Exhaled tidal volume (V

)

Inspired tidal volume during Leak

Sync

Accuracy

± (2+4% of reading) cmH

± (4 mL+15% of actual) mL

± (4 mL+10% of actual) mL

For adult and pediatric circuit type settings:

For T

≤600 ms: ± (10+20% ×600/T ms of reading) mL

Range

5 cmH

O to 90 cmH

3 cmH

O to 70 cmH

0 cmH

O to 45 cmH

5 cmH

O to 90 cmH

2 mL to 2500 mL

For adult and pediatric circuit type settings:

25 mL to 2500 mL

For neonatal circuit type settings:

2 mL to 310 mL

261

Table 68.

Monitoring (Patient Data) Accuracy (continued)

Parameter Accuracy

For T

>600 ms: (10+20% of read‐ ing) mL For neonatal circuit type setting: ± (10+20% of reading) mL

For readings <100 mL, the accuracy shall apply when the percentage of inspiratory leak volume is less than

80%

Exhaled tidal volume (V

Leak Sync

) during For adult and pediatric circuit type settings:

For T

600/T

≤ 600 ms: ± (10+20% ×

E ms of reading) mL

For T

>600 ms: ± (10 + 20% of read‐ ing) mL

For neonatal circuit type settings: ±

(10+20% of reading) mL For read‐ ings <100 mL, the accuracy shall apply when the percentage of inspiratory leak volume is less than

80%

Proximal exhaled tidal volume (V

TEY

) ± (1+10% of reading) mL

Proximal inspired tidal volume (V

TIY

) ± (1+10% of reading) mL

% (monitored) ±3%

Respiratory Rate ( f ) ±0.8 1/min

Range

For adult and pediatric circuit type settings:

25 mL to 2500 mL

For neonatal circuit type settings:

2 mL to 310 mL

15% to 100%

1 1/min to 150 1/min

Table 69.

Computed Value Accuracy

Parameter Accuracy Range

PAV-based lung compliance (C

PAV

) ± (1+20% of measured value) mL/cmH

PAV based total airway resistance

TOT

)

PAV based work of breathing

(WOB

TOT

)

± (0.5 + 10% of measured work) J/L with a percent support setting of

75%

10 to 100 mL/cmH

0.7 J/L to 4 J/L

± (3 + 20% of measured) cmH

O/L/s 5.0 to 50 cmH

O/L/s

Warning: The ventilator accuracies listed in this chapter are applicable under the operating conditions identified

in Table 63, page 247 .

Operation outside specified ranges cannot guarantee the accuracies listed in Table 67

through

Table 69

, and may supply incorrect information.

11.8 Regulatory Compliance

The ventilator complies with the following standards:

• IEC 60601-1:2005 Medical Electrical Equipment, Part 1: General Requirements for Basic safety and essential performance

• EN 60601-1:2006, Medical Electrical Equipment, Part 1: General Requirements for Basic safety and essential performance

262

• ANSI-AAMI ES 60601-1:2005, Medical Electrical Equipment, Part 1: General Requirements for Basic safety and essential performance

• CSA C22.2 No. 60601-1:2008 Medical Electrical Equipment, Part 1: General Requirements for Basic safety and essential performance

• IEC 60601-1-8:2006, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance

• EN 60601-1-8:2007, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance

• IEC 60601-2-12:2001, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance

• EN 60601-2-12:2005, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance

• ISO/EN 80601-2-12:2011, Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

• EN 1041:2008, Information supplied by the manufacturer of medical devices

• EN 980:2008, Symbols for use in the labeling of medical devices

• ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: symbol development, selection and validation

• ISO 7000:2004, Graphical symbols for use on equipment- Registered symbols - Fourth edition

• ISO 80601-2-55:2011 and EN ISO 80601-2-55: 2012, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - First Edition

• ISO 5356-1:2004, Anesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets

• EN 5356-1:2004, Anesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets

• ISO 10993-1:07-15-2010, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process TECHNICAL CORRIGENDUM 1 - Fourth Edition

• IEC 60601-1:1988, Medical Electrical Equipment, Part 1: General Requirements for Safety

• EN 60601-1:1990, Medical Electrical Equipment, Part 1: General Requirements for Safety

• IEC 60601-1-4:2000, Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral

Standard: Programmable Electrical Medical Systems

• IEC 62304:2006, Medical device software - Software life cycle processes

• IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

• IEC 62366:2007, Medical devices - Application of usability engineering to medical devices

• IEC/EN 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

• EU 2002/96/EC, Directive of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE)

• ISO 14971:2007/EN ISO 14971:2012, Medical devices - Application of risk management to medical devices

• IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests

• AIM Standard 7351731 Rev 2.00.2017: Medical Electrical Equipment and System Electromagnetic Immunity

Test for Exposure to Radio Frequency Identification Readers

263

11.9 Manufacturer’s Declaration

The following tables contain the manufacturer’s declarations for the ventilator system electromagnetic emissions, electromagnetic immunity, separation distances between ventilator and portable and mobile RF communications equipment and a list of compliant cables.

Warning: Portable and mobile RF communications equipment can affect the performance of the ventilator system. Install and use this device according to the information contained in this manual.

Warning: The ventilator system should not be used adjacent to or stacked with other equipment, except as may be specified elsewhere in this manual. If adjacent or stacked used is necessary, the ventilator system should be observed to verify normal operation in the configurations in which it will be used.

Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the ventilator, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Caution: This equipment is not intended for use in residential environments and may not provide adequate protection to radio communication services in such environments.

Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals

(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Table 70.

Electromagnetic Emissions

The ventilator is intended for use in the electromagnetic environment specified in Table 70

. The cus‐ tomer or the operator of the ventilator should assure that it is used in such an environment.

Emissions Test Compliance

Electromagnetic environment – guidance

Radiated RF emissions

CISPR 11

Conducted emissions

CISPR 11

Group 1

Class A

Harmonic emissions IEC 61000-3-2 Class A

Voltage fluctuations/flicker IEC

61000-3-3 Complies

The ventilator uses RF energy only for its internal functions. The venti‐ lator is intended to be used only in hospitals and not be connected to the public mains network.

The ventilator is intended to be used only in hospitals and not be connected to the public mains net‐ work.

Table 71.

Electromagnetic Immunity

EMC test Test standard Test levels Remarks

ESD

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-2

±2,4,6,8 kV contact discharge

±2,4,8,15 kV air dis‐ charge

N/A

Electromagnetic environment— guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity

264

Table 71.

Electromagnetic Immunity (continued)

EMC test

Radiated immunity

EFT burst

Surge

Conducted immunity

Test standard Test levels Remarks Electromagnetic environment— guidance should be at least

30%.

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 61000-4-3

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-3

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 61000-4-4

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-4

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-5

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 61000-4-6

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-6

10 V/m

3 V/m

Modulation: 80%

AM, 2 Hz

Modulation: 80%

AM, 1 kHz

N/A

5 kHz pulse repeti‐ tion rate

±1 kV (I/O)

±2 kV (AC Mains)

±05 kV,1 kV line to line

±05 kV,1 kV &2 kV line to earth

100 kHz pulse repe‐ tition rate

Mains power quality should be that of a typical hospital envi‐ ronment.

N/A

10 V

RMS

3 V

RMS

in the follow‐ ing frequency

ranges (ISM Bands a

);

• 6.765–6.795 MH z

• 13.553–13.567

MHz

• 26.957–27.283

MHz

• 40.66–40.70 MH z

6 V

RMS

3 V

RMS

in the follow‐ ing frequency

ranges (ISM Bands a

);

• 6.765–6.795 MH z

• 13.553–13.567

MHz

•

• 26.957–27.283

MHz

40.66–

40.70 MHz

Modulation:

80%AM, 2 Hz

Modulation: 80%

AM, 1 kHz

Portable and mobile

RF communications equipment should be used no closer to any part of the ven‐ tilator system, including cables, than the separation distance calculated from the equation applicable to the fre‐ quency of the trans‐

mitter. See Table 74

265

Table 71.

Electromagnetic Immunity (continued)

EMC test

Magnetic immunity

Test standard

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-8

Test levels

30 A/m

Remarks

N/A

Electromagnetic environment— guidance

Power frequency magnetic fields should be at levels characteristic of a typical hospital envi‐ ronment.

NOTE: U

is the AC mains voltage prior to application of the test level.

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 61000-4-11

• 95% minimum voltage reduc‐ tion for 0.5 peri‐ ods (10)

• 60% minimum voltage reduc‐ tion for 5 peri‐ ods (100)

Voltage dips

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-11

• 30% minimum voltage reduc‐ tion for 25 peri‐ ods (500)

• U

=0%, 0.5

cycle (0, 45, 90,

135, 180, 225,

270, and 350°)

• U

=0%; 1 cycle

• U

=70%; 25/30 cycles (@0°)

N/A

Mains power should be that of a typical hospital environ‐ ment. If the operator of the ventilator requires continuous operation during power mains inter‐ ruptions, it is recom‐ mended that the ventilator be pow‐ ered from an unin‐ terruptible power supply or a battery.

Interrupts

Proximity field from

RF wireless commu‐ nication equipment

IEC 60601-1-2, Edi‐ tion 3.0:2007

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-11

IEC 60601-1-2, Edi‐ tion 4.0:2014

IEC 61000-4-3

• U=0%; 250/300

See cycles

Table 72

Modulation: See

Table 72 .

N/A

RFID immunity

AIM Standard

7351731 Rev. 2.00

2017

IEC 61000-4-3

See Table 73

See section 7 in AIM

Standard 7351731 for more details on execution of the dif‐ ferent RFID specifi‐ cations.

N/A

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 to 6,795 MHz; 13.553 MHz to

13.567 MHz; 26.957 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz

266

11 and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the separation distance for transmitters in these frequency ranges.

Table 72.

Immunity to Proximity Fields RF Wireless Communications Equipment

Test fre‐ quency

(MHz)

Band (MHz) Service Modulation Maximum power (W)

385 380–390

TETRA 400 1,8

Distance (m) Immunity test level

(V/m)

0,3 27

450 430–470

• GMRS

460

• FRS 4 60

Pulse modula‐ tion 18 Hz

FM ±5 kHz deviation

1 kHz sine

2 0,3 28

710

745

780

810

870

704–787

LTE Band 13,

• GSM

800/900

Pulse modula‐ tion217 Hz

0,2 0,3 9

• TETRA

800

Pulse modula‐ tion 18 Hz

800–960 2 0,3 28

930

1720

1845

1970

1700–1990

• iDEN 820

• CDMA

850

• LTE Band

• GSM

1800

• CDMA

1900

• GSM

1900

• GSM

1900

DECT

• LTE Band

1, 3, 4, 25

Pulse modula‐ tion 217 Hz

2 0,3 28

2450

2400–2570

• UMTS

• Bluetoot h

• WLAN,

802.11

b/g/n

• RFID

2450

• LTE Band

Pulse modula‐ tion 217 Hz

2 0,3 28

267

Table 72.

Immunity to Proximity Fields RF Wireless Communications Equipment (continued)

Test fre‐ quency

(MHz)

5240

5500

5785

Band (MHz)

5100–5800

Service

WLAN

802.11a/n

Modulation

Pulse modula‐ tion 217 Hz

Maximum power (W)

0,2

Distance (m)

0,3

Immunity test level

(V/m)

Table 73.

AIM Standard Test Levels

RFID specification

ISO 14223

ISO/IEC 14443-3 (Type A)

ISO/IEC 14443-4 (Type B)

ISO/IEC 15693 (ISO 18000-3 Mode 1)

ISO 18999-3 Mode 3

ISO/IEC 18000-7

ISO/IEC 18000-63 Type C

ISO/IEC 18000-4 Mode 1

Frequency

134.2 kHz

13.56 MHz

433 MHz

860–960 MHz

2.45 GHz

Test level (RMS)

65 A/m

7.5 A/m

5 A/m

12 A/m

3 V/m

54 V/m

Table 74.

Recommended Separation Distances for RF

The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the operator of the ventilator can help prevent electromagnetic inter‐ ference by maintaining a minimum distance between portable and mobile RF communications equip‐ ment (transmitters) and the ventilator as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

150 kHz to 80 MHz outside of ISM bands

150 kHz to 80 MHz inside of ISM bands

80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01

0.1

100

0.117

0.37

1.17

3.7

11.7

0.12

0.38

1.2

3.8

0.12

0.38

1.2

3.8

0.23

0.73

2.3

7.3

For transmitters rated at a maximum output power not listed above, the recommended separation distanced

in meters (m) a

can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, as determined by an electromagnetic site survey the following symbol:

, should be less than the compliance level in each frequency range

c . Interference may occur in the vicinity of equipment marked with

268

Table 74.

Recommended Separation Distances for RF (continued)

Rated maximum output power of transmitter (W)

150 kHz to 80 MHz outside of ISM bands

150 kHz to 80 MHz inside of ISM bands

80 MHz to 800 MHz 800 MHz to 2.5 GHz

11 a The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to

2.5 GHz are intended to decrease the likelihood mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the separation distance for transmitters in these frequency ranges.

b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 980 Series Ventilator is used exceeds the applicable

RF compliance level above, the 980 Series Ventilator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ventilator.

c Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Warning: The use of accessories and cables other than those specified with the exception of parts sold by

Covidien as replacements for internal components, may result in increased emissions or decreased immunity of the ventilator system.

Table 75.

Recommended Cables

Part number and description

10087159, Power cord, 10A, RA, UK

10087155, Power cord, 10A, RA, EU

10087157, Power cord, 10A, RA, Japan

10087152, Power cord, 10A, RA, British

10087154, Power cord, 10A, RA, Swtzrlnd

10081056, Power cord, 10A, RA, USA

10087156, Power cord, 10A, RA, Israel

10087160, Power cord, 10A, RA, Brazil

10087153, Power cord, 10A, RA, China

10 ft (3 m)

Cable length

11.10 Safety Tests

All safety tests should be performed by qualified Service personnel at the interval specified. See

Table 44

11.11 Essential Performance Requirements

Per ISO/EN 80601-2-12: 2011, Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators, the ventilator’s essential performance requirements are given in

Ventilator Settings, Alarm Settings, and Patient Data tables earlier in this Chapter. Alarms, including Oxygen level

269

alarms and gas failure alarms, are identified in Chapter 6

. AC and battery backup power information is given in

Chapter 3

, and gas failure cross flow information is given in

Chapter 3

If essential performance is lost or degraded due to exposure of electromagnetic disturbance levels higher than

those described in Table 71

the following may occur:

• Component failures

• Changes in programmable parameters or settings

• Reset to default settings

• Changes to operating mode

• Initiation of an unintended operation

• Error in delivered volume of individual breaths greater than 35%

• Error in delivered minute volume greater than 25%

• False positive alarm condition

• Failure to alarm

270

12 Appendix BiLevel 2.0

12.1 Overview

This appendix describes the operation of the BiLevel 2.0 ventilation mode on the Puritan Bennett 980 Series

Ventilator.

BiLevel is a mixed mode of ventilation that combines attributes of mandatory and spontaneous breathing, with the breath timing settings determining which breath type is favored. In BiLevel Mode, mandatory breaths are always pressure-controlled, and spontaneous breaths can be pressure-supported (PS) or tube compensated (TC).

Figure 94.

Spontaneous Breathing at P

1 P

CIRC

(cmH

2 T

3 T

4 P

5 P

6 Spontaneous breaths

BiLevel resembles SIMV mode, except that BiLevel establishes two levels of positive airway pressure. Cycling between the two levels can be triggered by BiLevel timing settings or by patient effort.

Figure 95.

BiLevel Mode

1 Pressure (y-axis)

2 P

3 P

4 Spontaneous breath

5 Synchronized transitions

6 Pressure support

7 Time-based transitions

The two pressure levels are called Low Pressure (P

) and High Pressure (P

BiLevel monitors mandatory and spontaneous tidal volumes separately.

). At either pressure level, patients can breathe spontaneously, and spontaneous breaths can be assisted with tube compensation or pressure support.

Inspiratory time and expiratory time in BiLevel become Time high (T

H these inspiratory and expiratory times, P

is maintained during T

) and Time low (T

and P

), respectively. During

is maintained during T

271

12.2 Intended Use

BiLevel is intended for adult, pediatric, and neonatal patients.

12.3 Setting Up BiLevel

BiLevel is a ventilatory mode (along with A/C, SIMV, and SPONT).

To set up BiLevel

1. At the ventilator setup screen, enter PBW or gender and height.

2. Touch BiLevel . After selecting BiLevel mode, the ventilator uses the PC mandatory breath type, which cannot be changed.

3. Choose the spontaneous type (PS or TC).

4. Choose trigger type (P-Trig or ⩒ -Trig).

5. Select desired ventilator settings. The default settings for BiLevel mode appear. To change a setting, touch its button and turn the knob to set its value. P

must always be at least 5 cmH

O greater than P

6. Set T

, T

, or the ratio of T

to T

. To select settings that would result in a T

ratio greater than 1:1 or 4:1, you must touch Continue to confirm after reaching the 1:1 and 4:1 limits.

Figure 96.

BiLevel Setup Screen

7. Touch Start.

8. Set apnea and alarm settings by touching their respective tabs at the side of the ventilator settings screen and changing settings appropriately.

Note: The rise time% setting determines the rise time to reach target pressure for transitions from P

to P

H spontaneous breaths, even when pressure support (P

SUPP spontaneous breaths.

) = 0. Expiratory sensitivity (E

SENS

) applies to all

and for

12.4 Using Pressure Support with BiLevel

Spontaneous breaths in BiLevel mode can be assisted with pressure support according to these rules (See

Figure 97, page 273

272

• Pressure support (P

SUPP to P

) can be used to assist spontaneous breaths at P

. Target pressure = P

+ P

SUPP

and P

. P

SUPP

is always set relative

• Spontaneous patient efforts at P

are not pressure supported unless P

SUPP

> (P

–P

). All spontaneous breaths

(whether or not they are pressure supported) are assisted by a pressure of 1.5 cmH

• If P

SUPP

+ P

is greater than P

+1.5 cmH

2 all spontaneous breaths at P

O, all spontaneous breaths at P

are assisted by P

SUPP

–(P

–P

are assisted by the P

SUPP

setting, and

• All spontaneous breaths not supported by PS or TC (for example, a classic CPAP breath) are assisted with an inspiratory pressure of 1.5 cmH

For example, if P

= 5 cmH

O, P

= 15 cmH

O, and P

SUPP

=20 cmH

• All spontaneous breaths at P

25 cmH

O, and

are assisted by 20 cmH

O of pressure support (P

+ P

SUPP

) for a total pressure of

• All spontaneous breaths in P

H pressure of 25 cmH

are assisted by 10 cmH

O of pressure support (P

SUPP

–(P

–P

)) for the same total

Figure 97.

BiLevel with Pressure Support

1 Pressure (y-axis)

2 P

Pressure support =10 cmH

3 P

Pressure support =20 cmH

4 P

5 P

During spontaneous breaths, the pressure target is calculated with respect to P

12.5 Manual Inspirations in BiLevel Mode

Pressing the manual inspiration key during BiLevel mode causes the ventilator to:

• Cycle to P

, if the current pressure level is P

• Cycle to P

, If the current pressure level is P

To avoid breath stacking, the ventilator does not cycle from one pressure level to another during the earliest stage of exhalation.

12.6 Respiratory Mechanics Maneuvers in BiLevel

In BiLevel, respiratory mechanics maneuvers are limited to inspiratory pause and expiratory pause maneuvers.

12.7 Specifications

See the table,

Table 64 , for the following specifications:

273

• Low pressure (P

)

• High pressure (P

)

• Low pressure time (T

)

• High pressure time (T

)

• T

ratio

• Respiratory rate ( f )

• Rise time%

12.8 Technical Description

BiLevel is a mode of ventilation that alternately cycles between two operator-set pressure levels, P

and P

H pressure durations are defined by operator-set timing variables T

L levels, P

and P

, are analogous to breath phase transitions in PC.

and T

. The

. Transitions between the two pressure

At the extreme ranges of T

and T

, BiLevel can resemble the single breath type mode A/C - PC, or the more complex breath type mode, an “inverted-like” IMV. If T

and T example T

>1:2 or 1:3), then BiLevel assumes a breathing pattern similar to, if not qualitatively identical to A/C -

PC. However, as T

begins to shorten with the T pattern patented by John Downs

and defined as APRV.

assume “normal” values with respect to PBW (for

ratio extending beyond 4:1, the breathing pattern assumes a distinctly different shape. In the extreme, the exaggerated time at P

and abrupt release to P

would match the

In between the A/C-PC-like pattern and the APRV-like pattern, there would be patterns with moderately long T

H and T

intervals, allowing the patient sufficient time to breathe spontaneously at both P

and P

L spontaneous breath types. In this sense, BiLevel and SIMV are classified as mixed modes.

In these types of breathing patterns, (but less so with APRV) BiLevel, like SIMV, can be thought of as providing both mandatory and

Direct access to any of the three breath timing parameters in BiLevel is accomplished by touching the Padlock icon associated with the T screen.

period, T

period or the T

ratio displayed on the breath timing bar in the setup

While in BiLevel mode, spontaneously triggered breaths at either pressure level can be augmented with higher inspiratory pressures using Pressure Support (PS) or Tube Compensation (TC) breath types.

12.8.1 Synchrony in BiLevel

Just as BiLevel attempts to synchronize spontaneous breath delivery with the patient’s inspiratory and expiratory efforts, it also attempts to synchronize the transitions between pressure levels with the patient’s breathing efforts.

This allows T

H the T

to be extended to prevent transitions to P

during the patient’s spontaneous inspiration. Likewise,

interval may be extended to prevent a transition to P

during the patient’s spontaneous exhalation.

The trigger sensitivity setting (P

SENS

down to P

and T pattern.

or ⩒

SENS

) is used to synchronize the transition from P

intervals as necessary to synchronize the transitions between P

and P

to P

. The transition from

is synchronized with the patient’s spontaneous expiratory effort. The BiLevel algorithm will vary the

to match the patient’s breathing

The actual durations of T

and T

vary according to whether or not the patient makes any spontaneous inspiratory efforts during those periods.

To manage synchrony with the patient’s breathing pattern, the BiLevel algorithm partitions the T

into spontaneous and synchronous intervals as shown in Figure 98

and T

periods

4 Downs, JB, Stock MC. Airway pressure release ventilation: A new concept in ventilatory support. Crit Care Med

1987;15:459-461

274

Figure 98.

Spontaneous and Synchronous Intervals

1 Pressure (y-axis)

2 T

3 P

4 P

5 T

6 Synchronous interval

7 Spontaneous interval

By partitioning T

and T

into spontaneous and synchronous phases, BiLevel responds to patient efforts (or lack of them) in a predictable pattern:

• During the spontaneous interval of each pressure level, successful inspiratory efforts cause the ventilator to deliver spontaneous breaths.

• During T

L synchronous intervals, successful inspiratory efforts cause the ventilator to cycle from P

L there is no spontaneous (patient) effort, this transition takes place at the end of the T

period.

to P

. If

• During T

H synchronous intervals, successful expiratory efforts cause the ventilator to cycle from P

to P

. If there is no spontaneous exhalation, the transition to the P

level takes place at the end of the T

period.

12.8.2 Patient Monitoring in BiLevel

If the patient breathes spontaneously at either pressure level, BiLevel monitors and displays the total respiratory rate, including mandatory and spontaneous breaths. BiLevel also displays the exhaled tidal volume and total exhaled minute volume for both mandatory and spontaneous breaths.

12.8.3 APRV Strategy in BiLevel

Lengthening the T

period and shortening the T breath volume, results in an inverse T

period to only allow incomplete exhalation of the mandatory

ratio. In this breath timing configuration with T

4:1, BiLevel becomes A irway P ressure R elease V entilation (APRV).

ratios of greater than

APRV is characterized as longer T

periods, short T

periods (usually less than one second), and inverse T

Since, at these breath timing settings, all of the patient-triggered spontaneous breaths occur during the T

APRV resembles CPAP ventilation with occasional, short periods of incomplete exhalation referred to as

“releases“ which are controlled by the f setting.

ratios.

period,

275

Figure 99.

APRV With Spontaneous Breathing at P

1 P

CIRC

(cmH

2 Lengthened inspiratory time (T

)

3 Shortened release time (T

)

In APRV, the P

level is set to optimize pulmonary compliance for spontaneous breathing while maintaining an elevated mean airway pressure to promote oxygenation, the P

level is set, along with the T

, to control the expiratory release volume of mandatory breaths to help manage CO controls the number of releases per minute which are used to help manage the patient’s CO also impacts the mean airway pressure.

and alveolar ventilation, and the f setting

levels. The f setting

In APRV the operator can configure the BiLevel settings to allow direct control of T setting will not inadvertently lengthen the T

With the T

period locked, changes in set f will change the T maintaining the set T

period.

to assure that changes in the f

period resulting in destabilization of end-expiratory alveolar volume.

period to accommodate the new f setting while

12.8.4 Technical Structure of BiLevel

In BiLevel, the ventilator establishes two levels of baseline pressure. One level is essentially the same as the standard PEEP level set for all common modes of ventilation. The second pressure level is the level established at

. Both pressure levels permit CPAP, TC and PS breaths. The breath timing settings determine whether the patient can initiate any of these breath types.

12.9 Mode Changes

Changing to BiLevel mode from other modes follows the general guidelines for mode changes:

• The change is made as soon as possible without compromising inspiration or exhalation.

• Breaths are not stacked during inspiration.

276

13 Appendix Leak Sync

13.1 Overview

This appendix describes the operation of the Puritan Bennett 980 Series Ventilator Leak Sync function. Leak Sync enables the ventilator to compensate for leaks in the breathing circuit while accurately detecting the patient’s effort to trigger and cycle a breath. Because Leak Sync allows the ventilator to differentiate between flow due to leaks and flow due to patient respiratory effort, it provides dynamic compensation and enhances patient-ventilator synchrony. See

Chapter 4

in this manual for general parameter and operational information.

13.2 Intended Use

Leak Sync is designed to compensate for leaks in the breathing circuit during noninvasive or invasive ventilation.

Leak Sync accurately quantifies instantaneous leak rates, therefore detecting patient respiratory phase transitions correctly and may affect work of breathing. Leak Sync is intended for neonatal, pediatric, and adult patients.

13.3 Safety Reminder

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

13.4 Leak Sync

Breathing circuit leaks can cause the ventilator to erroneously detect patient inspiratory efforts (called autotriggering) or delay exhalation in pressure support. Patient interfaces such as masks are particularly prone to significant leaks. Inaccurately declaring inspiration or exhalation can result in patient-ventilator dysynchrony and increased work of breathing.

Changing inspiratory or expiratory sensitivity settings can temporarily correct the problem, but requires continued frequent clinical intervention to ensure that sensitivity is adjusted appropriately as conditions change

(for example, if the patient moves or the circuit leak changes).

Leak Sync adds flow to the breathing circuit to compensate for leaks. The maximum Leak Sync flow applies to the maximum base flow compensation during exhalation. During pressure-based inspirations, the total delivered flow (leak flow plus inspiratory flow) is limited by the maximum total flow.

Table 76

shows the maximum leak rates at set PEEP pressure that Leak Sync will compensate based on patient type.

Table 76.

Maximum Leak Compensation Flow Based on Patient Type

Neonatal

Pediatric

Adult

Patient type Maximum leak compensation flow at PEEP

Invasive: 15 L/min

NIV: 30 L/min (25 L/min if the com‐ pressor is the air source)

40 L/min (25 L/min if the compres‐ sor is the air source)

65 L/min (25 L/min if the compres‐ sor is the air source)

Maximum total flow

50 L/min

120 L/min

200 L/min

Warning: With significant leaks, pressure targets may not be reached due to flow limitations.

277

13.5 Setting Up Leak Sync

For more information on setting up the ventilator, see Chapter 4 .

To enable Leak Sync

1. At the ventilator setup screen, touch the More Settings tab.

2. Touch Enabled in the Leak Sync area.

3. Touch Accept ALL to enable Leak Sync.

Figure 100.

Enabling Leak Sync

Note: The default value for Leak Sync is Disabled when the circuit type is Pediatric or Adult and the ventilation type is Invasive. Otherwise the default value for Leak Sync is Enabled .

Note: Leak Sync is not allowed for tube compensated (TC) and Proportional Assist Ventilation (PAV+™) breath types.

13.6 When Leak Sync is Enabled

See

Figure 101, page 279

for an example showing the GUI screen when Leak Sync is enabled.

• The Vent Setup button on the GUI screen indicates Leak Sync is active.

• D

SENS

is displayed in units of L/min, rather than %.

• If the ventilator detects a leak during a respiratory mechanics maneuver, the message Leak Detected is displayed.

• A new leak or change in leak rate is typically quantified and compensated within three breaths. Monitored patient data stabilizes within a few breaths.

• Select inspiratory sensitivity settings as usual. if the ventilator auto-triggers, try increasing flow sensitivity

( ⩒

SENS

Note: The absence of the Leak Detected message does not mean there is no leak.

Note: Leak Sync is automatically enabled when ventilation type is NIV or if New Patient is selected and circuit type is neonatal, regardless of the ventilation type. If Leak Sync is disabled while the ventilation type is invasive but the

278

13 ventilation type is changed to NIV, it remains disabled. Leak Sync becomes disabled when ventilation type is set to Invasive and circuit type is adult or pediatric.

Figure 101.

GUI Screen when Leak Sync is Enabled

1 LS appears on vent setup button notifying the operator that Leak Sync is enabled

13.6.1 Adjusting Disconnect Sensitivity (D

SENS

)

When Leak Sync is enabled, the Circuit Disconnect alarm becomes active based on the D

SENS maximum allowable leak rate at set PEEP.

setting, which is the

When Leak Sync is disabled, D

SENS

is automatically set to 75%.

Warning: When Ventilation Type = NIV and Leak Sync is disabled, D

SENS

is automatically set to OFF.

See

Table 76 for a summary of D

SENS maximum Leak Sync flow.

settings when Leak Sync is enabled. Note that it is possible to set D

SENS

below

Table 77.

SENS

Settings

Breathing circuit type

Neonatal

Maximum total flow

50 L/min

Pediatric

Adult

SENS

setting

Range:

Invasive: 1 L/min to 15 L/min

NIV: 1 L/min to 30 L/min

Default: 2 L/min (Invasive ventila‐ tion) 5 L/min (NIV)

Range: 1 L/min to 40 L/min

Default: 20 L/min

Range: 1 L/min to 65 L/min

Default: 40 L/min

120 L/min

200 L/min

Warning: Setting D

SENS

higher than necessary may prevent timely detection of inadvertent extubation.

279

13.6.2 Monitored Patient Data

When Leak Sync is enabled, three additional parameters are displayed on the More Patient Data screen and updated for each breath. Display the More Patient Data screen by swiping the tab on the patient data banner.

These leak parameters may also be configured on the patient data banner and the large font patient data panel.

Figure 102.

Leak Sync Monitored Patient Data

1 Leak Sync Parameters

See

Table 66, page 256 for information regarding the following monitored patient data parameters:

• V

LEAK

• % LEAK

• LEAK

Displayed values for Exhaled Tidal Volume (V

) and Inspired Tidal Volume (V

TL indicate the estimated inspired or exhaled lung volume. The accuracies for V

) are leak-compensated, and

and V

also change when Leak

Sync is enabled (see Technical Discussion for more information). Graphic displays of flow during Leak Sync indicate estimated lung flows.

13.7 Technical Discussion

Managing breathing circuit leaks is important to ensure appropriate breath triggering and cycling, ventilation adequacy, and valid patient data. Detecting and monitoring leaks can improve treatment, reduce patient work of breathing, and provide more accurate information for clinical assessments.

Leak Sync recognizes that changing pressures lead to varying deflection of interface materials and leak sizes. The

Leak Sync leak model includes a rigid leak orifice whose size remains constant under changing pressures, combined with an elastic leak source whose size varies as a function of applied pressure. This algorithm provides a more accurate estimate of instantaneous leak to improve patient-ventilator synchrony under varying airway pressures.

280

Leak Sync allows the ventilator to determine the leak level and allows the operator to set the flow trigger and peak flow sensitivities to a selected threshold. The base flow during exhalation is set to:

• Flow triggering: 1.5 L/min + estimated leak flow at PEEP + flow sensitivity.

• Pressure triggering: 1.0 L/min + estimated leak flow at PEEP.

13.7.1 Inspired Tidal Volume (V

) Accuracy During Leak Sync

See

Table 66, page 256 , V

parameter, for V

accuracy.

For readings < 100 mL, accuracy ranges apply when the percentage of inspiratory leak volume is < 80%, where the percentage of leak volume is:

(Leak volume during inspiration / total delivered inspiratory volume) × 100

Note: Inspired tidal volume is labeled as V

when Leak Sync is enabled, and as V

when Leak Sync is disabled.

13.7.2 Exhaled Tidal Volume (V

) Accuracy During Leak Sync

See

Table 66, page 256 , V

parameter, for accuracy when Leak Sync is enabled.

where T

= time to exhale 90% of volume actually exhaled by the patient.

For readings <100 mL, accuracy ranges apply when the percentage of inspiratory leak volume is < 80%, where the percentage of leak volume is:

(Leak volume during inspiration/total delivered inspiratory volume) × 100

13.7.3 %LEAK Calculation

See

Table 66, page 256 , % LEAK parameter, for specifications.

13.7.4 Circuit Disconnect Alarm During Leak Sync

The Circuit Disconnect alarm is activated if the overall leak volume during the whole breath exceeds the maximum leak volume derived from the D end-inspiratory pressure falls below (set PEEP +1 cmH alarm message:

SENS

setting. During VC, the Circuit Disconnect alarm is also activated if the

O) for three consecutive breaths. The screen shows this

281

Figure 103.

Circuit Disconnect During VC

If the compressor is in use and the D

SENS

setting > 25 L/min, a D

SENS

of 25 L/min is used to determine Circuit

Disconnect. If LEAK > 25 L/min, the alarm banner shows the following message:

Check patient. Reconnect circuit. Leak may exceed maximum compensation value for compressor.

Normal operation resumes if the ventilator detects a patient connection.

282

14 Appendix PAV™+

14.1 Overview

This appendix describes the operation of PAV+™ software for the Puritan Bennett 980 Series Ventilator.

Proportional assist ventilation (PAV+™) is designed to improve the work of breathing of a spontaneously breathing patient by reducing the patient’s increased work of breathing when pulmonary mechanics are compromised.

The PAV+™ breath type differs from the pressure support (PS) breath type in the following way:

PAV+™ acts as an inspiratory amplifier; the degree of amplification is set by the % Support setting (% Supp). PAV+™ software continuously monitors the patient’s instantaneous inspiratory flow and instantaneous lung volume, which are indicators of the patient’s inspiratory effort. These signals, together with ongoing estimates of the patient’s resistance and compliance, allow the software to instantaneously compute the necessary pressure at the patient wye to assist the patient’s inspiratory muscles to the degree selected by the % Supp setting. Higher inspiratory demand yields greater support from the ventilator.

PAV+™ software reduces the risk of inadvertent entry of incompatible settings, such as small predicted body weight (PBW) paired with a large airway.

14.2 Intended Use

PAV+™ is intended for use in spontaneously breathing adult patients whose ventilator predicted body weight

(PBW) setting is at least 25.0 kg (55 lb). Patients must be intubated with either endotracheal (ET) or tracheostomy

(Trach) tubes of internal diameter (ID) 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive.

14.3 Safety Information

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

Warning: PAV+™ is not an available breath type in non-invasive ventilation (NIV). Do not use non-invasive patient interfaces such as masks, nasal prongs, uncuffed ET tubes, etc. as leaks associated with these interfaces may result in over-assist and patient discomfort.

Warning: Breathing circuit and artificial airway must be free from leaks. Leaks may result in ventilator over-assist and patient discomfort.

Warning: Ensure high and low tidal volume alarm thresholds are set appropriately because an overestimation of lung compliance could result in an under-support condition resulting in the delivery of smaller than optimal tidal volumes.

14.4 PAV+™

Warning: Ensure that there are no significant leaks in the breathing circuit or around the artificial airway cuff.

Significant leaks can affect the performance of PAV+™ and the accuracy of resistance (R) and elastance (E) estimates.

Warning: Do not use silicone breathing circuits with PAV+™ : the elastic behavior of a silicone circuit at the beginning of exhalation can cause pressure-flow oscillations that result in underestimates of patient resistance.

The act of inspiration requires the patient’s inspiratory muscles to develop a pressure gradient between the mouth and the alveoli sufficient to draw in breathing gas and inflate the lungs. Some of this pressure gradient is dissipated

283

as gas travels through the artificial airway and the patient’s conducting airways, and some of the pressure gradient is dissipated in the inflation of the lungs and thorax. Each element of pressure dissipation is characterized by a measurable property: the resistance of the artificial and patient airways, and the compliance (or elastance) of the lung and thorax.

PAV+™ software uses specific information, including resistance of the artificial airway, resistance of the patient’s airways, lung-thorax compliance, instantaneous inspiratory flow and lung volume, and the % Supp setting to compute the instantaneous pressure to be applied at the patient connection port (patient wye). PAV+™ software randomly estimates patient resistance and compliance approximately every four to ten breaths. Every 5 ms, the software estimates lung flow, based on an estimate of flow at the patient wye, and lung volume, based on the integral of the value of estimated lung flow.

PAV+™ begins to assist an inspiration when flow (generated by the patient’s inspiratory muscles) appears at the patient wye. If the patient ceases inspiration, the assist also ceases. Once inspiratory flow begins, PAV+™ software monitors instantaneous flow and volume every 5 ms and applies the pressure calculated to overcome a proportion (determined by the % Supp setting) of the pressure losses dissipated across the resistances of the artificial and patient airways and lung-thorax compliance.

Because the PAV+™ algorithm does not know the patient’s mechanics when the PAV+™ breath type is selected, the software performs a startup routine to obtain initial data. At startup, PAV+™ software delivers four consecutive

PAV+™ breaths, each of which includes an end-inspiratory pause maneuver that yields estimates of the patient’s resistance and compliance. The first breath, however, is delivered using the predicted resistance for the artificial airway and conservative estimates for patient resistance and compliance, based on the patient’s PBW.

Each of the next three PAV+™ breaths averages stepwise decreased physiologic values with the estimated resistance and compliance values from the previous breath, weighting earlier estimates less with each successive breath, and yielding more reliable estimates for resistance and compliance. The fifth PAV+™ breath (the first non-startup breath) is delivered using the final estimates with the clinician-set % Supp setting. Once startup is complete, the PAV+™ software randomly applies a maneuver breath every four to ten breaths after the last maneuver breath to re-estimate patient resistance and compliance. New values are always averaged with former values.

PAV+™ graphically displays estimates of patient lung pressure (intrinsic PEEP), patient compliance, patient resistance, total resistance, total work of inspiration, patient work of inspiration, inspiratory elastic work (an indicator of lung-thorax work), and inspiratory resistive work.

The % Supp setting ranges from a minimum of 5% (the ventilator performs 5% of the work of inspiration and the patient performs 95%) to a maximum of 95% (the ventilator performs 95% of the work and the patient performs

5%), adjustable in 5% increments.

PAV+™ also includes alarm limits, safety checks, and logic checks that reject non-physiologic values for patient resistance and compliance as well as inappropriate data.

14.4.1 Setting Up PAV+™

To set up PAV+™

1. At the ventilator setup screen, enter the patient’s gender and height or the patient’s PBW.

2. Touch Invasive ventilation type.

3. Touch SPONT mode.

4. Touch PAV+™ to select Spontaneous Type.

5. Touch the desired trigger type (P-Trig or ⩒ -Trig).

6. Select tube type

284

7. Select the tube ID. Initially, a default value is shown based on the PBW entered at ventilator startup. If this

ID is not correct for the airway in use, turn the knob to adjust the ID setting.

8. Continue setting up the ventilator as described in Chapter 4

Figure 104.

Ventilator Setup Screen

Note: If the operator selects an internal diameter that does not correspond to the allowable values, touch

Continue to override the tube ID setting. If attempts are made to choose a tube ID less than 6.0 mm or greater than

10 mm, a hard bound limit is reached, as PAV+™ is not intended for use with tubes smaller than 6.0 mm or larger than 10.0 mm. When touching Dismiss, the setting remains at the last tube ID selected. Touch Accept or Accept

ALL to accept changes, or touch Cancel to cancel changes.

Note: If Leak Sync is currently enabled, it becomes disabled when PAV+™ is selected.

Note: When the ventilator is used on the same patient previously ventilated using PAV+™, the GUI displays an attention icon and the tube type and tube ID previously used, as a reminder to the clinician to review those settings during ventilator setup.

14.4.2 PBW and Tube ID

The ventilator uses “soft bound” and “hard bound” values for estimated tube inside diameters based upon PBW.

Soft bounds are ventilator settings that have reached their recommended high or low limits. When adjusting the tube size, if the inside diameter does not align with a valid predicted body weight, a Continue button appears.

Setting the ventilator beyond these soft bounds requires the operator to acknowledge the prompt by touching

Continue before continuing to adjust the tube size. The limit beyond which the tube ID cannot be adjusted is called a hard bound, and the ventilator emits an invalid entry tone when a hard bound is reached.

Warning: Ensure that the correct artificial airway ID size is entered. Because PAV+™ amplifies flow, entering a smaller-than-actual airway ID causes the flow-based pressure assistance to over-support the patient and could lead to transient over-assist at high values of % Supp. Conversely, entering a larger-than-actual ID results in under-support. PAV+™ software monitors the settings for the PBW and artificial airway. If the PBW and tube ID settings do not correspond to allowable values, confirm or correct the settings. Confirming or correcting the actual ID size minimizes the likelihood that PAV+™ will over-support or under-support.

285

To apply new settings for the artificial airway follow these steps

1. Touch the vent setup button at the lower left of the GUI screen.

2. Touch Tube Type and turn the knob to select Trach or ET to set the tube type.

3. Touch Tube ID and turn the knob to set the tube ID.

4. Touch Accept or Accept ALL to apply the new settings, or Cancel to cancel.

To apply new humidifier settings

1. Touch the More Settings tab.

2. Touch the appropriate button for Humidification Type.

3. For non-HME humidification types, touch Humidifier Volume, then turn the knob to adjust the (empty) humidifier volume.

4. Touch Accept ALL to apply the changes.

Warning: To ensure the accuracy of PAV+™ breaths and spirometry measurements, run SST following any change to the humidification type or humidification volume settings. Ensure that the intended circuit is used with the SST.

14.4.3 Apnea Parameters Adjustment

After accepting the PAV+™ settings, touch the apnea setup screen. Adjust the apnea parameters as required.

14.4.4 Alarm Settings Adjustment

PAV+™ includes the high inspired tidal volume ⤒ V

) and low exhaled spontaneous tidal volume alarm ( ⤓ V

SPONT

) alarm limit settings. See

Section 14.4.8, PAV+™ Alarms, page 287 .

Note: Because of the breathing variability that PAV+™ allows, the ⤓ V

TE SPONT

alarm, by default, is turned OFF to minimize nuisance alarms. To monitor adequate ventilation, use the ↓ ⩒

E TOT

alarm condition instead.

To adjust alarm settings

1. Touch the Alarm tab to view the current alarm settings.

2. Touch the button for each alarm limit requiring a change.

3. Turn the knob to adjust the value of the alarm limit. Proposed values are highlighted. You can change more than one alarm limit before applying the changes.

4. Touch Accept or Accept All to apply the changes, or Cancel to cancel.

14.4.5 PAV+™ Ventilator Settings

See

Table 64 for a summary of PAV+™ ventilator settings for the following parameters:

• %

Supp

• Expiratory sensitivity (E

SENS

)

• Tube type

• Tube ID

• Trigger type

14.4.6 PAV+™ Alarm Settings

See

Table 65 for a summary of the following alarm settings available when PAV+™ is active:

• High inspired tidal volume limit ( ⤒ V

)

• Low exhaled spontaneous tidal volume ( ⤓ V

TE SPONT

)

286

14.4.7 Monitored Data

See

Table 66 for the following monitored data associated with PAV+™:

• PAV-based lung compliance (C

PAV

)

• PAV-based lung elastance (E

PAV

)

• PAV-based lung resistance (R

PAV

)

• PAV-based total airway resistance (R

TOT

)

• Inspired tidal volume (V

)

• Driving Pressure (P

DRIVE

)

See

Table 78 for monitored data absolute limits.

Table 78.

Absolute limits for PAV+™ Monitored Data

PBW (kg)

PAV

(cmH

0 to 50

0 to 44

0 to 31

0 to24

0 to 20

O/L/s)

115

125

135

145

150

105

0 to 18

0 to 17

0 to 16

0 to 15

0 to 14

PAV

(mL/cmH

2.5 to 29

3.5 to 41

4.5 to 52

5.5 to 64

6.4 to 75

7.4 to 87

8.4 to 98

9.4 to 110

10 to 121

11 to 133

12 to 144

13to 156

14 to 167

15 to 173

PAV

(cmH

O/L)

34 to 400

24 to 286

19 to 222

16 to 182

13 to 156

11 to 135

10 to 119

9.1 to 106

8.3 to 100

7.5 to 91

6.9 to 83

6.4 to 77

6.0 to 71

5.8 to 67

14.4.8 PAV+™ Alarms

See

Table 37 for a summary of the following alarms associated with PAV+™:

• High circuit pressure ( ↑ P

PEAK

)

• High ventilator pressure( ↑ P

VENT

)

• PAV STARTUP TOO LONG

• PAV R&C NOT ASSESSED

• ↑ V

14.5 Ventilator Settings and Guidance

Warning: For optimal performance of PAV+™, it is important to select the humidification type, tube type, and tube size that match those in use on the patient.

The instantaneous pressure generated at the patient wye during inspiration is a function of the patient effort, %

Supp setting, tube type and size, patient resistance and elastance, and the instantaneously measured gas flow and lung volume. Set ⤒ P

PEAK

to a safe circuit pressure, above which truncation and alarm annunciation are appropriate.

Note: PAV+™ has a built-in high pressure compensation ( ↑ P

COMP

) limit that is determined by the ⤒ P

PEAK minus 5 cmH

O or 35 cmH

O, whichever is less. If the inspiratory pressure at the patient wye (P

Iwye

setting

) reaches the

287

↑ P

COMP

limit, the inspiration is truncated, and the ventilator transitions to exhalation. See Section 14.5.5

for more details regarding ↑ P

COMP

and ↑ P

PEAK

14.5.1 Specified Performance

Performance using PAV+™ is ± 0.5 Joules/liter (J/L), compared to measured, work during inspiration at the 75% support (% Supp) level. Work is computed over the entire inspiratory interval. In ventilation terms, work (W) is expressed as:

Figure 105.

Work [J/L] i

P ith sample interval (5 ms)

Work [J/L]

Synchronous and combined pressures developed by the ventilator and by the patient (P

MUS

), [cmH

V k

Flow [L/s] conversion constant (0.098) [J/cmH

O x L]

14.5.2 Graphics Displays in PAV+™

When PAV+™ is active (the mode is SPONT and the spontaneous breath type is PAV+™), a work of breathing (WOB)

graphic is automatically displayed (See Figure 106, page 289 ) which shows:

• an indicator showing the proportion of patient inspiratory work to overcome the elastance (E) of the lung-thorax and the combined resistance (R) of the artificial airway and the patient.

• estimates of work of breathing relative to normal, subnormal, and above-normal values, including:

– the estimated work of breathing in Joules/L) during inspiration (WOB

) and

– the estimated total work of breathing (in Joules/L) of the patient and ventilator during inspiration

(WOB

TOT

)

Additional information in the graphics screen includes:

• a “shadow” trace of the estimated lung pressure, shown as a solid area superimposed on the circuit pressure waveform, and

• PAV-based patient data estimates, including patient resistance (R

PAV

PEEP (PEEP

I PAV

), lung compliance (C

PAV

), and intrinsic

Note: Graphic displays of lung pressure and patient work of breathing are not actual measurements, and are derived from equations using filtered estimates of pressure and flow.

The WOB graphic is only available when SPONT mode and the PAV+™ breath type are selected. The shadow trace can be enabled or disabled when selecting the graphic display, or after a display is paused.

The act of pausing does not affect the WOB graphic, but does store the shadow trace. Once paused, the operator can enable or disable the shadow trace, then view the paused waveform again with or without the shadow trace.

14.5.3 WOB Terms and Definitions

Table 79 provides a definition and description of each of the work-of- breathing (WOB) terms.

288

Table 79.

PAV+™ Work of Breathing Terms

WOB

WOB term

TOT

Definition

Total work of inspiration

WOB

PT ELASTIC

WOB

PT RESISTIVE

Patient work of breathing

Inspiratory elastic work

Inspiratory resistive work

Figure 106.

Graphics displays in PAV+™

Description

With the PAV+™ breath type active, the patient and the ventilator always share the in the work of breathing.

The percent WOB

WOB

TOT

performed by the ventilator always equals the % Supp setting and the percent

performed by the patient always equals (100 minus the % Supp setting). WOB

TOT

is the sum of the work to move the breathing gas through the artificial airway and the patient’s own airways plus the work to inflate the patient’s elastic lung-thorax.

That part of WOB

TOT

performed by the patient.

That part of WOB

PT elastic lung-thorax.

attributed to inflating the patient’s

That part of the WOB

attributed to moving breathing gas through resistive elements in the gas path.

1 Total work of breathing (WOB

TOT

)

2 Patient’s work of breathing (WOB

)

3 Shadow trace

14.5.4 Technical Description

When PAV+™ is selected, the ventilator acts as an inspiratory amplifier, proportionally assisting the pressure generating capability of the inspiratory muscles (P

MUS

14.5.4.1 Pressure Gradient Equation of Motion

During spontaneous breathing, P

MUS

generates a pressure gradient that drives breathing gas through the artificial airway and the patient’s airways and into the elastic lung-thorax, and is described by the equation of motion:

289

Figure 107.

EQUATION 1

⩒

MUS

Pressure generating capability of patient’s inspiratory muscles

Flow through the resistance elements and into the lungs

Insufflation volume of the lung

LUNG-

THORAX

Resistance elements (artificial plus patient airways)

Elastance of the lung and thorax (1/C

THORAX

)

LUNG-

14.5.4.2 Estimates of Patient Resistance and Elastance

If the PAV+™ software estimates of patient resistance and elastance (R

PAV could be rewritten as:

and (E

PAV

) remain stable, this equation

Figure 108.

EQUATION 2 i Instantaneous value of pressure, flow, or air‐ way resistance, R flow i airway

being a function of

PAV

P i

MUS

could then be estimated at every control period if V i

, R i airway

, and V i

were also known.

14.5.4.3 Valid Individual Pressure Measurements

Throughout any inspiration, the individual pressure elements that make up P

MUS

can be expressed as:

Figure 109.

EQUATION 3

MUS

FLOW

ARTIFICIAL AIRWAY

PATIENT

VOLUME

PATIENT

Pressure generating capability of patient’s inspiratory muscles

Flow based pressure drop across the artificial airway

Flow based pressure drop across the patient

Volume based pressure to overcome the lung-thorax elastance

Equations 2 and 3 provide the structure to explain how PAV+™ operates. The clinician enters the type and size of artificial airway in use, and the software uses this information to estimate the resistance of the artificial airway at any lung flow.

Applying a special pause maneuver at the end of selected inspirations provides the information the software needs to estimate patient resistance (R

PAV

) and compliance (C

PAV

, which is converted to elastance, E

PAV

Immediately following the end of the pause event, software captures simultaneous values for P which yield an estimate for R

TOT

at the estimated flow.

LUNG

, P wye

, and ⩒

All raw data are subjected to logic checks, and the estimates of R

PAV

and C

PAV checks. The estimates of R

PAV

is also rejected.

and C

PAV

are further subjected to physiologic

are discarded if any of the logic or physiologic checks fail. If C

PAV

is rejected,

290

Valid estimates of R

PAV

If new values for R

PAV

and C

PAV

are required for breath delivery, and are constantly updated by averaging new values with previous values. This averaging process smooths data and avoids abrupt changes to breath delivery.

refresh.

and C

PAV

are rejected, the previous values remain active until valid new values are obtained.

PAV+™ software monitors the update process and generates an escalating alarm condition if the old values do not

14.5.4.4 Maneuver Breaths and % Supp

During PAV+™, maneuver breaths are randomly performed every four to ten breaths after the last maneuver breath. A maneuver breath is a normal PAV+™ inspiration with a pause at end inspiration. Because muscle activity is delayed for at least 300 ms following the end of neural inspiration, the patient’s respiratory control center does not detect the pause. With this approach, maneuver breaths are delivered randomly so that their occurrence is neither consciously recognized nor predictable.

A PAV+™ breath begins, after the recognition of a trigger signal, with flow detection at the patient wye. The sample and control cycle of the ventilator (the value of i in Equation 2) is frequent enough to yield essentially constant tracking of patient inspiration. At every ith interval, the software identifies instantaneous lung flow (V of instantaneous lung volume, (V i

), which is impeded by the elastic recoil of the lung and thorax).

, which is impeded by the resistances of the artificial airway and patient airways) and integrates this flow to yield an estimate

Using the values for instantaneous lung flow and lung volume, PAV+™ software calculates each of the pressure elements in Equation 2, which gives the value of P

MUS

at each ith interval.

At this point, Equation 2 and the subsequent analysis identifies that an appropriate patient, supported by PAV+™ and with an active P

MUS

(an absolute requirement) will, within a few breaths, enable the algorithm to obtain reasonable estimates of R

PAV

and E

PAV

. Once these physiologic data are captured (and over a relatively brief time they are improved and stabilized), the PAV+™ algorithm mirrors the patient’s respiratory mechanics, which then allows the ventilator to harmoniously amplify P

MUS

. The key point to recognize is that patient’s continuous breathing effort “drives“ the PAV+™ support — no effort, no support.

The % Supp setting specifies the amount of resistance- and elastic-based pressure to be applied at each ith interval at the patient wye.

By taking all of the aforementioned information into consideration, EQUATION 2 can be rewritten to include the

% Supp setting recognizing that V i

and V i

are driven by the patient, not by the ventilator. (It is important to note that the ventilator is not amplifying its own flow — only the flow generated by P

MUS

Figure 110.

EQUATION 4

P i wye

Pressure generated by the ventilator in response to the instantaneous values of lung flow and lung volume at the wye. This value is the sum of the three individual pres‐ sure elements (in parentheses) in Equation

S % Supp setting/100 (ranges from 0.05 to

0.95)

14.5.4.5 Resulting Pressure Gradient

The pressure gradient driving breathing gas into the patient’s lungs is given by the sum of P inspiratory effort, therefore: i wye

and the patient’s

291

Figure 111.

EQUATION 5

DP i gradient

Instantaneous pressure gradient

P i wye

Pressure generated by the ventilator in response to the instantaneous values of lung flow and lung volume at the wye

P i

MUS

Instantaneous pressure generating capa‐ bility of patient’s inspiratory muscles

14.5.5 Protection Against Hazard

PAV+™ software is designed to reduce the risk that hyperinflation may occur. The potential for hyperinflation could arise if the software were to overestimate actual patient resistance or underestimate actual patient lung-thorax compliance (that is, to overestimate actual elastance). If the software cannot generate valid estimates of R

PAV

, PAV+™ cannot start. If, after startup, the values of R

PAV

and C

PAV previous values become less reliable.

and

cannot be updated with valid new values, the

The stability of PAV+™ is primarily determined by the relationship between the true lung elastance [E the true lung volume [V

L elastic component.

(true)]. Although P i wye

(true)] and

(resistive) also plays a part, the following discussion focuses on the

At all lung volumes, the true state of the lung and thorax is expressed by:

Figure 112.

Lung Volume

V i

L recoil i

L (true)

True lung recoil pressure

True instantaneous volume of the lung

L (true)

True lung elastance

Over-inflation will not occur as long as P i wye (elastic) < P i

L recoil

, which is equivalent to the inequality:

S[V i

(estimated) x K

] < V i

(true) x E

(true) where:

= E

PAV

As long as E

PAV

(estimated) = E

PAV

(true) and V

Supp (i.e. between 85% and 95%).

(estimated) = V i

(true) then P i recoil

> P i wye

even at high values of %

This means that if the pressure applied to the lung-thorax is never greater than E collapse if wye flow vanishes. As long as E

PAV

≤ R

(true), P

MUS

is the modulator of P i wye.

(estimated) ≤ E

(true), V i

(true) × V

(estimated) ≤ V i

, lung volume will

(true), and R

PAV

(estimated)

Hyperinflation could occur if the estimated E wye (elastic) could exceed P i

L recoil

PAV

were greater than the true value of E

. At a high % Supp setting, P i

, causing a self-generating flow at the patient wye, which in turn would cause a self-generating inflation of the lungs. This is part of the reason that the % Supp setting is limited to 95%.

Likewise, if the estimated R

PAV

were to exceed the true value of R

at a high % Supp setting, P i wye

(resistive) could exceed the value necessary to compensate for pressure dissipation across the artificial and patient airways, resulting in early hyperinflation of the lungs. As flow declines after the first third of inspiration, however, the hyperinflating effect would most likely disappear.

5 See equations 2 and 4.

292

PAV+™ software includes these strategies to minimize the possibility of hyperinflation of the lungs:

1. The maximum % Supp setting is limited to 95%.

2. The raw data for R

PAV

and C

PAV

are checked for graph/math logic, and estimated mechanics values are checked against PBW-based physiologic boundaries. These checks reduce the possibility of overestimating patient resistance or underestimating patient compliance, which could lead to potential over-inflation.

3. The high inspiratory tidal volume limit ( ⤒ V

) places an absolute limit on the integral of lung flow (including leak flow), which equals lung volume. If the value of V

TI and immediately transitions to exhalation.

reaches this limit, the ventilator truncates inspiration

4. The ( ⤒ V

) setting places an upper limit on the value of the P VOLUME

PATIENT

component of P i wye

3 and 4). At the beginning of each new inspiration, PAV+ software calculates a value for P follows:

(see Equations

VOLUME

PATIENT

P* wye

(elastic threshold limit) = 0.75 × (V

× E

PAV

) where P*

P i wye wye

is the unique value for the elastic threshold limit of P expand to 75% of ( ⤒ V

). When P i wye

(elastic) = P* wye reaching the ⤒ V

5. The high inspiratory pressure limit ( ⤒ P

PEAK i wye

) applies to all breaths, and is used by PAV+ software to detect the high compensation pressure condition ( ↑ P

COMP

that will cause the lung volume to

(elastic threshold limit), the software stops increasing

(elastic). This means that any further increase in lung volume must be accomplished by the patient, which tends to hasten the conclusion of inspiratory effort and avoid truncation due to lung volume

limit.

↑ P

COMP

= ⤒ P

PEAK

–5 cmH

O or 35 cmH

O, whichever is less

If the user-adjustable ⤒ P

PEAK transitions to exhalation. If P i

limit is reached, the ventilator truncates inspiration and immediately wye

(the targeted wye pressure calculated in Equation 4) equals the

500 ms, the inspiration is truncated and exhalation begins. Further, when P

↑ P

COMP

⤒ P

PEAK

. Although this freezes the value of P

, causing inspiration to end.

i wye i wye

= ↑ P

COMP

, P i wye

↑ P

COMP

is limited to

, patient activity such as coughing could drive P i wye

for

The rapid rise of P i wye

to the ↑ P

COMP were overestimated and % Supp were set above 85%. The ↑ P due to overestimation of R

PAV

limit would likely occur in the first third of inspiration, and only if R

COMP

PAV

condition guards against over-inflation

6. The% Supp setting ranges from 5% to 95% in 5% increments. Reducing the level of support decreases the possibility of over-inflation. A significant decrease could produce a sensation of inadequate support, and the patient would absorb the additional work of inspiration or require an increase in the level of support.

A significant increase could cause a surge in the ventilator generated value for P wye cause P i wye

to reach ⤒ P

COMP

, which in turn could

and lead to temporary patient-ventilator disharmony. To minimize this possibility, PAV+™ software limits the actual increase in support to increments of 10% every other breath until the new setting is reached.

7. Spirometry remains active during PAV+ operation. ⤒ V

TI breaths, while ⤓⩒

E TOT

and ⤒⩒

E TOT

can be set high enough to allow spontaneous sigh

remain active to reveal changes in minute ventilation.

Because PAV+ cannot operate without valid estimates of R

PAV

and C unknown when PAV+ starts, a startup routine obtains these values during four maneuver breaths that include an end inspiratory pause that provides raw data for R

PAV

and C

, and because those values are

PAV

maneuver breath at the next breath. See Section 14.4, PAV+™, page 283 .

, and both estimated values must be valid. If either value is invalid during any of the four startup breaths, the software schedules a substitute

A low-priority alarm becomes active if a 45-second interval elapses without valid estimates for R

PAV

. If the condition persists for 90 seconds, the alarm escalates to medium-priority. If the condition persists for 120 seconds, the alarm escalates to high priority. The ↑ ⩒

E TOT this condition.

and ↑ f

TOT

PAV

and

alarms are also associated with

293

Similarly, if R

PAV

and C

PAV

cannot be updated with valid values after a successful PAV+ startup, a low-priority alarm is activated if the condition persists for 15 minutes. If the values still cannot be updated with valid values after 30 minutes, the alarm escalates to medium priority.

8. If PAV+ estimates a high lung resistance following a sharp spike in the expiratory flow waveform, then a

PBW-based resistance value is used. See

Figure 113 and Table 80, page 294 .

Figure 113.

Use of Default Lung Resistance

1 Flow (V)

2 Expiratory Phase

3 Inspiration

4 Exhalation with slow, restricted return to zero flow

Table 80.

Default PBW-based Resistance Values

PBW (kg) Resistance

(cmH

/s)

O/L

25 18.1

17.7

17.4

17.1

16.8

16.5

PBW (kg) Resistance

(cmH

/s)

O/L

43 13.5

13.3

13.2

13.0

12.9

12.7

16.2

15.9

15.7

15.4

15.2

14.9

14.7

14.5

14.3

14.1

13.9

13.7

12.6

12.4

12.3

12.2

12.1

12.0

11.8

11.7

11.6

11.5

11.4

11.3

5 High peak expiratory flow

6 Exhalation with normal return to zero flow

7 Normal peak expiratory flow

PBW (kg) Resistance

(cmH

/s)

O/L

61 11.3

11.2

11.1

11.0

10.9

10.8

10.7

10.6

10.5

10.4

10.3

10.2

PBW (kg) Resistance

(cmH

/s)

O/L

79 10.1

81 to 150

10.1

294

15 Appendix NeoMode 2.0

15.1 Overview

This appendix describes how to use NeoMode 2.0 software on the Puritan Bennett 980 Series Neonatal Ventilator.

NeoMode 2.0 enables the use of the ventilator with neonatal patients and is included with all Puritan Bennett 980

Neonatal Ventilators and Puritan Bennett 980 Universal Ventilators. For a Puritan Bennett 980 Pediatric– Adult ventilator to be used with neonatal patients, the NeoMode 2.0 software option must be installed.

15.2 Intended Use

NeoMode 2.0 is intended to provide respiratory support to neonatal patients with predicted body weights as low as 0.3 kg (0.66 lb). It is intended to cover a wide variety of clinical patient conditions in hospitals and hospital-type facilities, and may be used during intra-hospital and intra-hospital-type facility transport. It supports delivered tidal volumes as low as 2 mL.

15.3 Description

The ventilator determines values for operational variables and allowable settings based on breathing circuit type and predicted body weight (PBW). The PBW range for neonates is 0.3 kg to 7.0 kg (0.66 lb to 15 lb). Software controls prevent inadvertent mismatching of patient size and breathing circuit type. A neonatal breathing circuit connects to a neonatal exhalation filter that must be used with the neonatal adapter door assembly.

Note: To enable NeoMode 2.0, select the neonatal breathing circuit type in SST. Breathing circuit type can only be changed during SST.

15.4 Safety Information

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations, and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

Warning: Neonatal patients are at risk for hypercarbia or hypoxemia during ↓ ⩒

E TOT

alarm conditions.

Warning: Disabling the low exhaled minute volume ( ↓ ⩒

E TOT hypoxemia.

) alarm increases the patient’s risk of hypercarbia or

Warning: When using NIV, the patient’s exhaled tidal volume (V patient data value for V

) could differ from the ventilator’s monitored

due to leaks around the interface. To avoid this, ensure Leak Sync is enabled.

15.5 Neonatal Door and Filter Installation

Warning: Removing the exhalation filter while the patient is connected to the ventilator can cause a loss of circuit pressure, ventilator autotriggering, or direct contact with liquid.

Caution: Do not pull on the door while the exhalation filter latch is closed, as damage to the ventilator can result.

Note: See the inspiratory filter and exhalation filter IFUs for information on filtration efficiency and filter resistance.

To install the neonatal adapter door

295

1. Remove the expiratory limb of the patient circuit from the exhalation filter.

2. Lift the exhalation filter latch. See

Figure 114 .

3. Remove the existing exhalation filter door by lifting it off of the pivot pins.

4. Fit the neonatal adapter door onto the pivot pins.

To install neonatal exhalation filter assembly

1. With the door still open, push the neonatal filter straight up into the adapter.

2. Close the door.

3. Lower the exhalation filter latch.

4. Reattach the expiratory limb of the patient circuit to the filter.

Figure 114.

Installing the Neonatal Filter and Door

1 Neonatal exhalation filter

2 Neonatal adapter door

3 Exhalation filter latch

4 Filter door pivot pin

Warning: To ensure all breathing circuit connections are leak-tight, perform a circuit-leak test by running

SST every time the filter is installed. The circuit-leak test can be performed as an individual test from the SST startup screen.

Warning: Empty the condensate vial before the liquid level reaches the maximum fill line. Condensate vial overflow can enter the filter or the breathing circuit, and can cause increased expiratory flow resistance.

Change the filter if it appears to be saturated.

Warning: The neonatal exhalation filter and condensate vial is a single unit and is for single patient use, only.

Do not attempt to sterilize the filter assembly.

Warning: Adding accessories to the ventilator can change the pressure gradient across the ventilator breathing system (VBS) and affect ventilator performance. Ensure any changes to the recommended ventilator circuit configurations do not exceed the specified values for inspiratory and expiratory pressure

drop. See Table 59 . If adding accessories to the patient circuit, always run SST to establish circuit compliance

and resistance prior to ventilating the patient.

Note: If the ventilator has not reached operating temperature from recent usage, allow it to warm up for at least 15 minutes before running SST to ensure accurate testing.

Note: Check the inspiratory and expiratory limbs of the breathing circuit and in-line water traps regularly for water buildup. Under certain conditions, they can fill quickly. Empty and clean the in-line water traps as necessary. See the manufacturer’s IFU for additional information.

15.6 How to Empty the Condensate Vial

The condensate vial may accumulate liquid, especially if a non-heated wire patient circuit is in use.

296

Warning: To avoid liquid entering the ventilator, empty the condensate vial before the liquid level reaches the maximum fill line.

The condensate vial assembly is integrated with the neonatal exhalation filter and does not contain a drain port.

Empty the condensate vial when liquid reaches the maximum fill line.

To empty the condensate vial

1. While holding the exhalation filter, twist the condensate vial clockwise approximately one quarter turn to remove it.

2. Remove the condensate vial by carefully lowering the vial all the way down to the base of the exhalation compartment and then sliding it out.

3. Quickly empty the condensate vial.

4. Replace the condensate vial by carefully sliding the vial into position, lifting it upward to the filter assembly, and turning counterclockwise until it reaches the stop.

Note: Condensate vial removal may cause the loss of system pressure and a disconnect alarm to sound.

15.7 How to Connect the Breathing Circuit

Warning:

Use one of the ventilator breathing circuits listed. Table 81, page 298

or their equivalent. This ensures that maximum pressure and flow values specified by EN794- 1 are not exceeded. Using a circuit with a higher resistance does not prevent ventilation, but can cause an SST fault or compromise the patient’s ability to breathe through the circuit.

See

Figure 115, page 297

to connect the breathing circuit.

Figure 115.

How to Connect the Breathing Circuit 15

297

1 Humidifier

2 Patient circuit inspiratory limb

3 Patient circuit wye

4 Patient circuit expiratory limb

5 Condensate vial

6 From patient port

7 Neonatal exhalation filter (installed in adapter door)

8 To patient port

9 Inspiratory filter

Table 81.

Recommended Breathing Circuits

Patient circuit

Assy, patient circuit, neonatal, single heated wire, disposable, incubator use, for F&P

MR850–(Medtronic / DAR) use with adapter 111/1146

Assy, patient circuit, neonatal, single heated wire, disposable, not for incubator use, for

F&P MR850– (Medtronic / DAR) use with adapter 111/1146

Ventilator breathing circuit, neonatal, dual heated system, disposable, Fisher & Pay‐

kel–(Fisher & Paykel) a

Part number

307S9910

307/8682

RT265 a The part numbers listed reflect the breathing circuit manufacturer part numbers and are subject to change. Refer to the breathing circuit manufacturer for exact circuit details regarding ordering information.

Table 82 lists allowable ventilator settings when using NeoMode and ventilating invasively and non-invasively.

Table 82.

Allowable NeoMode Ventilator Settings and Ventilation Type

Ventilation type

Mode

Mandatory type spontaneous type

Trigger type

A/C, SIMV SPONT, BiLevel

PC, VC, VC+

PS, VS

⩒ -Trig

Invasive

A/C, SIMV SPONT, CPAP

PC, VC

⩒ -Trig

NIV

15.8 Ventilation Features

Ventilation using NeoMode 2.0 is performed as described in Chapter 4 (see the Ventilator Operation section). If using a Puritan Bennett 980 Series Neonatal Ventilator, NeoMode 2.0 is already in use and a neonatal patient circuit is the only choice available when performing SST. If using a Puritan Bennett 980 Series Universal Ventilator, the

NeoMode 2.0 software option is already installed and SST must be run using a neonatal circuit to use the option.

If using a Puritan Bennett 980 Series Pediatric– Adult Ventilator, the NeoMode 2.0 software option must be installed and SST must be run using a neonatal patient circuit.

15.8.1 SST (Short Self Test)

Warning: Always run SST prior to patient ventilation, ensuring that all accessories used during ventilation are in the ventilator breathing system when SST is run. This ensures correct calculation of compliance and resistance. See

Section 15.8.1, SST (Short Self Test), page 298

for more information.

If using a humidifier, the appropriate compressible volume must be entered before running SST. Refer to Chapter 3

for instructions on setting the humidification volume to the correct value listed in the shaded column in Table 83

Note: The manufacturer’s published chamber or column compressible volumes typically represent the container volume when empty and may not result in correct system compliance compensation for breath delivery and spirometry.

298

Table 83.

Humidifier Volumes - Neonatal Patients

Manufacturer

Fisher & Paykel

Teleflex (Concha)™*

AirLife™*

Model

MR290

382-10

AH290

Description

Neo/adult, disposable, autofeed

ConchaSmart

Disposable, autofeed

SST humidifier volume setting (mL)

550

390

520

a If the following neonatal patient circuits are used with a Fisher & Paykel MR850 humidifier, enter 500 mL as the humidifier volume: DAR neonatal patient circuit with single heated wire (DAR 307S9910)–for incubator use, DAR neonatal patient circuit with single heated wire (DAR 307/8682)–not for incubator use

15.8.2 Predicted Body Weight (PBW) Versus Patient Length

See Section 4.6, Predicted Body Weight (PBW) Calculation, page 106 for references to tables of PBW values associated

with patient length in centimeters and inches, respectively.

15.8.3 Elevate O

In NeoMode 2.0, the elevate O

control works as described in

Chapter 3 .

15.8.4 CPAP Mode

When using NeoMode 2.0 and ventilating with Non-Invasive Ventilation (NIV), a separate CPAP mode allows spontaneous breathing with a desired PEEP level. To limit inadvertent alarms associated with the absence of returned volumes in CPAP breathing, CPAP does not make volume alarms available. As some neonates don’t trigger breaths, the default apnea interval, T

, is set to OFF. Also, some settings changes will initiate a PEEP restoration breath before phasing in those changes.

Note: In CPAP, apnea interval,T also displayed.

, can be adjusted, if desired. It merely defaults to OFF to avoid inadvertent alarms.

The message “APNEA DETECTION DISABLED” is displayed at the bottom of the GUI screen. The attention icons are

To set the ventilator for CPAP

1. Select New Patient from the ventilator’s startup screen or touch the vent setup button.

2. Touch PBW, and turn the knob to set the PBW.

3. Select NIV as the ventilation type.

4. Touch CPAP.

5. Touch each ventilator setting and turn the knob to select the appropriate ventilator settings. When finished, touch START or Accept ALL .

6. Complete the setup by setting the apnea parameters and alarm limits from their respective tabs.

299

Figure 116.

CPAP Setup Screen

15.8.5 Entering CPAP From Other Ventilation Modes

Entering CPAP mode from other ventilation modes or ventilation types requires using the NIV ventilation type.

Section 4.7, Non-invasive Ventilation (NIV), page 107

explains how the ventilator transitions from Invasive to NIV ventilation type.

To enter CPAP mode for an existing patient

1. Touch the vent setup button at the lower left of the GUI screen.

2. Touch NIV ventilation type. CPAP is only allowed during NIV.

3. Touch CPAP. The ventilator enters CPAP mode.

4. Set an apnea interval, T

, if appropriate, as it defaults to OFF in CPAP.

Note: Exhaled minute volume ( ⩒

E TOT disabled upon entry into CPAP.

), exhaled tidal volume (V

TE SPONT

), and inspired tidal volume (V

) alarms are

15.8.6 Exiting CPAP Mode

When changing the mode from CPAP to any other mode, several transition rules take effect:

• The ⩒

E TOT

, V

TE MAND

TE SPONT

, and V

alarms are set to their respective new patient defaults.

• The apnea interval T

A immediately.

changes from OFF to an apnea interval of 10 s and the new setting is phased in

• The ⩒

E TOT

, V

TE MAND

, V

TE SPONT

, and V applicability to the selected mode.

alarm sliders appear in the alarm settings screen according to their

15.8.7 Compliance Compensation

See

Section 10.6, Compliance and BTPS Compensation, page 203

for a complete discussion of compliance compensation. Compliance compensation in NeoMode 2.0 is implemented as described in the aforementioned reference.

Note: If the patient’s compliance decreases beyond the limits of compliance compensation, the ventilator relies on the ⤒ P

PEAK

alarm setting to truncate the breath and switch to exhalation.

300

15.8.8 Settings, Alarms, and Monitored Patient Data

Warning: Monitor the patient closely if alarms are disabled. There are no audible or visual annunciations for out-of-range conditions when volume, pressure, or apnea alarms are disabled (turned OFF).

See Table 64 ,

Table 65

, and

Table 66

for the minimum and maximum ranges for each ventilator setting or data value.

Most settings, however, are also limited by other settings or conditions (for example, a low alarm limit is always limited by the corresponding high alarm limit). Review the prompt area when making settings changes.

Volume accuracy testing in VC+ was conducted to demonstrate performance of delivered and monitored parameters.

Table 84 , Table 85 , and Table 86 provide a summary of the actual results obtained within the range of

2 mL to 25 mL collected during test execution.

The first column (set tidal volume) represents the desired volume setting in milliliters (mL). The second column represents the total number of test points for test cases executed at that specific setting. The third column is the mean (mean value) of the ventilators and test cases executed for the setting listed. The fourth column represents the standard deviation (SD) of measurements taken for the ventilators and test cases executed at the setting listed.

The measurements were taken using instrumentation located at the patient-connection port. Accessories such as filters and humidifiers were in the circuit during the test. Values were BTPS and compliance compensated. A sample size of five ventilators was used to conduct the testing. Testing was conducted at ambient temperatures of 22°C ±5°C.

Table 84.

Delivered Volume Accuracy

Set tidal volume (mL) Number of test points

2 150

270

240

270

Mean value (mL)

2.061

4.853

15.108

24.608

0.198

0.324

0.383

0.607

Table 85.

Monitored Inspired Volume (VTI) Accuracy

Set tidal volume (mL) Number of test points

2 150

270

240

270

Mean value (mL)

2.055

4.872

15.235

24.633

Table 86.

Monitored Exhaled Tidal Volume (V

) Accuracy

Set tidal volume (mL) Number of test points

150

270

240

270

Mean value (mL)

2.212

5.892

16.145

25.492

0.192

0.346

0.379

0.566

0.274

0.607

0.851

0.819

301

302

16 Appendix Proximal Flow

16.1 Overview

This appendix describes the operation of the Proximal Flow option for the Puritan Bennett 980 Series Ventilator.

The Proximal Flow option is solely used for monitoring flows, pressures, and tidal volumes and does not control these parameters in any way.

The proximal flow sensor is designed to measure the lower flows, pressures and tidal volumes at the patient wye typically associated with invasively ventilated neonatal patients.

For general parameter and general ventilator setup information, see

Chapter 4

16.2 Intended Use

The Proximal Flow option is used for measuring flows, pressures, and tidal volumes of invasively ventilated neonatal patients with predicted body weights (PBW) of 0.3 kg (0.66 lb) to 7.0 kg (15.4 lb) using ET tube sizes from

2.5 mm to 4.0 mm. The NeoMode 2.0 software option must also be installed on the ventilator.

16.3 Safety Information

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

Warning: Inspect the proximal flow sensor prior to use, and do not use it if the sensor body, tubing, or connector are damaged, occluded, or broken.

Warning: Do not use the proximal flow sensor if there are kinks in the tubing.

Warning: Prior to patient ventilation with the Proximal Flow option, run SST with the exact configuration that will be used on the patient. This includes a neonatal patient circuit, Proximal Flow Sensor, and all accessories used with the patient circuit. If SST fails any proximal flow sensor test, check the patient circuit and the proximal flow sensor for leaks or occlusions and replace the flow sensor, if necessary. If SST continues to fail, it may indicate a malfunction or a leak within the Proximal Flow hardware which could compromise accuracy or increase the likelihood of cross-contamination; thus, replace the proximal flow hardware.

Warning: Changing ventilator accessories can change the system resistance and compliance. Do not add or remove accessories after running SST.

Warning: If the Proximal Flow o fails to respond as described in this appendix, discontinue use until correct operation is verified by qualified personnel.

Warning: The proximal flow sensor measures gas flow at the patient wye. The actual volume of gas delivered to the patient may be affected by system leaks between the patient and the proximal flow sensor, such as a leak that could occur from the use of an uncuffed endotracheal tube.

Warning: Position the proximal flow sensor exactly as described in this appendix or the IFU provided with the sensor.

303

Warning: Do not position the proximal flow sensor cables or tubing in any manner that may cause entanglement, strangulation or extubation which could lead to hypercarbia or hypoxemia. Use the cable management clips supplied to mitigate this risk.

Warning: To reduce the risk of extubation or disconnection, do not apply tension to or rotate the proximal flow sensor by pulling on the proximal flow sensor’s tubing.

Warning: Do not install the proximal flow sensor in the patient circuit if the sensor is not also connected to the

BDU.

Warning: Excessive moisture in the proximal flow sensor tubing may affect the accuracy of the measurements.

Periodically check the sensor and tubing for excessive moisture or secretion build-up.

Warning: The proximal flow sensor is intended for single use only. Do not reuse the sensor. Attempts to clean or sterilize the sensor may result in bioincompatibility, infection, or product failure risks to the patient.

Warning:

Install the proximal flow sensor as shown in Figure 122, page 311 . Improper orientation of the flow sensor

could lead to misinterpretation of data or incorrect ventilator settings.

Caution: Do not use aerosolized medications with the proximal flow sensor. Such medications may damage the sensor.

Caution: To prevent damage to pneumatic lines, use supplied cable management clips.

Caution: Use only Covidien proximal flow sensors with the Proximal Flow option.

16.4 Proximal Flow Option Description

The Proximal Flow option measures pressure, flow, and volume at the patient wye. A printed circuit board assembly (PCBA) containing the electronics and pneumatics for the Proximal Flow option is installed in the ventilator on the option host PCBA. Data measured by the proximal flow sensor are displayed on the GUI for monitoring purposes, not for ventilator control. When the ventilator has a proximal flow sensor installed, both proximal flow and proximal pressure measurements are obtained and displayed on the GUI.

A manual purge control is also provided to clear pneumatic lines for accurate pressure measurements. When a manual purge is requested, the ventilator will not allow another purge for at least 30 seconds. See

Section 16.7,

Sensor Calibration and Sensor Line Purging, page 307

for more information on the purge function.

16.4.1 Proximal Flow Option components

The Proximal Flow option consists of the following components:

Proximal flow option PCBA – Installed on the option host PCBA in the BDU, this printed circuit board assembly contains a pressure sensor to measure the pressure difference between the flow sensor lines and the interfaces required to convert analog measurements from the proximal flow sensor into digital data displayed by the ventilator. The PCBA also contains valves and an accumulator for purging the sensor lines from blockages.

Proximal flow sensor – The Puritan Bennett proximal flow sensor is required for use with the Proximal Flow option. The sensor is installed near the patient circuit wye. The other end of the sensor connects to the ventilator’s front panel behind a clear door designed to protect the connection point from exposure to spills or from sprayed liquids during cleaning and disinfection.

304

Figure 117.

Proximal Flow Sensor

VEN_10297_A

16.5 Software and Hardware Requirements

The Proximal Flow option requires installation of the NeoMode 2.0 software option or a Puritan Bennett 980

Neonatal Ventilator must be used. Details regarding NeoMode 2.0 can be found in the

Chapter 15 .

The following hardware is required:

• Option host PCBA

• Proximal flow sensor

Proximal Flow option hardware installation must be performed by a Covidien-trained service technician, using separate installation instructions.

16.6 On-screen symbols

When using the Proximal Flow option, flow, pressure, and volume waveform data, along with delivered and exhaled volumes are derived from proximal flow sensor measurements at the patient circuit wye. Proximal flow data are displayed on the waveform plot with a Y appearing in inverse video next to the measurement symbol.

305

Figure 118.

Sample GUI screen Showing Proximal Flow Data

1 Data measured using Proximal Flow Sensor P

– Pressure throughout the breath cycle at patient circuit wye V

– Flow throughout the breath cycle

(at patient circuit wye)

Inspired and exhaled flows and volumes at the patient wye are measured and identified by the symbols shown in

Table 87

and correspond to their non-proximal flow equivalents. These values appear in the patient data panel if so configured. See

Section 3.8.2.7, Vital Patient Data, page 81

and

Figure 118

Table 87.

Proximal Flow Option Data Symbols

Data symbol

TIY

TEY

TE SPONTY

TE MANDY

⩒

E TOTY

TLY

Description

Inspired tidal volume (mandatory or spontaneous at patient circuit wye)

Exhaled tidal volume (at patient circuit wye)

Exhaled spontaneous tidal volume (at patient circuit wye)

Exhaled mandatory tidal volume (at patient circuit wye)

Exhaled total minute volume (at patient circuit wye)

Flow throughout the breath cycle (at patient circuit wye)

Inspired tidal volume (at patient circuit wye with Leak Sync enabled)

Note:

In the patient data symbols shown above, the “Y” appears in inverse video, as shown. See Figure 118, page 306 .

Note: When the Proximal Flow and Leak Sync functions are enabled, the following parameters are available for display:

1. V

TLY

and V

2. LEAK and LEAK

When only the Proximal Flow option is enabled, V

TIY

and V

are available for display.

When a “Y” appears in the symbol, the data are measured with the proximal flow sensor. When a “Y” is absent from the symbol, the data are measured by the ventilator’s internal flow sensors.

306

16.7 Sensor Calibration and Sensor Line Purging

To ensure accurate pressure and flow measurements, the ventilator performs an autozero function to calibrate the proximal flow sensor. It does this by periodically opening the pressure sensor on the Proximal Flow option PCBA to atmosphere during exhalation, and uses the resulting measurements as offset corrections.

The purge function is designed to clear the pneumatic lines of fluids that may collect, and is performed periodically by sending a brief flow of air through the sensor lines. Autozero and purge functions are only active during exhalation which limits the effect of the purge gas on delivered oxygen concentration.

During the autozero or automatic purge processes, the measurement and display of proximal flow data is not shown in real time and a brief message appears on the GUI indicating the purge process is occurring.

During autozero or automatic purge processes, the pressure waveforms, when shown display the current PEEP value and the flow waveform, when shown, displays a value of 0.

Figure 119.

Message During Autozero and Purge Processes

16.8 SST Requirements

SST must be run prior to ventilation and all circuit components and accessories must be installed in the configuration to be used on the patient for the ventilator to calculate the correct compliance and resistance. This includes a neonatal patient circuit, Proximal Flow Sensor, and other accessories used during ventilation. See

Section 3.9.1.2, SST Test Sequence, page 85 . There is also a table listing the general SST test sequence located in

Chapter 3

. See Table 88, page 308

for a listing of the test sequence when running SST with the Proximal Flow option.

Note: Failure of the Proximal Flow option to pass SST does not prevent ventilation, but will prevent measurement with the proximal flow sensor. The ventilator will use its internal flow sensors for measurement instead of the proximal flow sensor.

307

Table 88.

Proximal Flow Option SST test Sequence

Test Step

SST Flow Sensor Cross Check

SST EV Performance

SST Circuit Pressure

SST Leak

SST Exhalation Filter

Function

Tests O

and Air Flow Sensors

Calibrates the exhalation valve and creates a table for use during calcu‐ lations.

Exercises delivery PSOL. Checks inspiratory and expiratory autozero solenoids. Cross-checks inspiratory and expiratory pressure transducers at various pressures.

Tests ventilator breathing system for leaks.

Checks for exhalation filter occlu‐ sion and exhalation compartment occlusion.

SST Circuit Resistance

SST Circuit Compliance

SST Prox

N/A

Comments

Checks for inspiratory and expira‐ tory limb occlusions, and calculates and stores the inspiratory and expir‐ atory limb resistance parameters.

Calculates the attached patient cir‐ cuit compliance.

Verifies functionality of Proximal

Flow System.

Ventilator prompts the user to block the proximal flow sensor outlet dur‐ ing Leak test. When prompted to reconnect the patient to the exha‐ lation filter during the Exhalation Fil‐ ter test, resume blocking the proxi‐ mal flow sensor outlet.

N/A

Includes tests of barometric pres‐ sure, autozero, purge, and pressure cross check functions.

16.8.1 Attaching the Proximal Flow Sensor for SST

During SST the ventilator prompts to attach the proximal flow sensor.

To attach the proximal flow sensor to the patient circuit

1. Verify the proximal flow sensor, pneumatic lines, and connector are not damaged.

2. Open the connector panel door and firmly attach the sensor connector to the receptacle in the BDU’s front connector port labeled Prox Flow.

308

Figure 120.

Attaching the Proximal Flow Sensor to the Ventilator

1 Proximal Flow Sensor connector insertion port

2 Proximal Flow Sensor connector

3. When prompted, block the breathing circuit wye.

4. When prompted to attach the Proximal Flow Sensor, unblock the circuit wye and insert the smaller end of the sensor into the wye.

5. When prompted, cap or seal the larger end of the sensor (marked with “UP” and an arrow).

6. Follow the prompts to complete SST.

If SST fails, check the patient circuit and flow sensor connections for leaks or occlusions and replace the Proximal

Flow Sensor, if necessary. Replace the Proximal Flow option hardware if SST continues to fail, then repeat SST to determine circuit compliance and resistance. See the Puritan Bennett 980 Series Ventilator Hardware

Options Installation Instructions for instructions on replacing the Proximal Flow option hardware.

16.9 Disabling and Enabling the Proximal Flow Option

The proximal flow sensor can function in the Enabled state only if the circuit type is neonatal. Assuming the

Proximal Flow option is available and the ventilation type is Invasive, the new patient default value is enabled.

After SST has been performed, the clinician may disable the Proximal Flow option, if desired.

To disable or enable the Proximal Flow option

1. In the constant access icons area, touch the configure icon. A menu containing tabs appears.

2. Touch the Options tab. A screen appears containing the Installed Options and Prox tabs.

3. Touch Enabled or Disabled to enable or disable the Prox Flow option.

309

Figure 121.

Enabling or Disabling Proximal Flow Sensor

Note: If the Proximal Flow option has been disabled or enabled, SST does not have to be re-run unless the breathing circuit or other breathing system accessories have been changed, removed, or added.

16.10 Using the Proximal Flow Sensor

Review and follow all warnings prior to patient ventilation with the proximal flow sensor. See

Section 1.3, Safety

Information, page 14

and ensure the Proximal Flow Sensor option is enabled.

To connect the proximal f sensor to the ventilator:

1. Verify the proximal flow s, pneumatic lines, and connector are not damaged in any way.

2. Open the connector panel door and firmly attach the sensor connector to the right-most receptacle in the

BDU’s front connector port labeled Prox Flow. See Figure 120, page 309 .

To attach the proximal flow sensor between the endotracheal tube and patient circuit

1. Connect the larger end of the sensor (marked with “UP” and an arrow) to the endotracheal tube. See

Figure 122, page 311 . Do not force the connection; when the sensor is oriented correctly, insertion requires

little effort.

Note: If using a heat-moisture exchanger (HME) on the endotracheal tube, place the proximal flow s between the HME and the breathing circuit wye.

310

Figure 122.

Attaching Proximal Flow Sensor

1 Endotracheal tube

2 Breathing circuit wye

2. Connect the smaller end of the sensor to the breathing circuit wye.

3. Ensure the sensor tubing is positioned in an upward direction, as shown in the figure above. If the sensor needs repositioning, do not rotate it by pulling on the tubing. Reposition as follows: a. Grasp the sensor’s plastic body with one hand and the breathing circuit wye with the other hand.

b. Rotate the sensor body and wye towards each other until the sensor tubing is upright.

c. Confirm a tight connection between the sensor and breathing circuit wye.

4. Use the three cable management clips provided with the sensor to attach the sensor tubing to the breathing circuit tubing. Space the clips evenly along the length of the sensor tubing. Twist the ends of each clip to close.

Note: When the ventilator is set up for Proximal Flow option operation, the proximal flow sensor can be switched as necessary. There is no need to run SST after switching sensors unless the breathing circuit or other ventilator accessories have been changed.

16.10.1 How to Perform a Manual Purge

A manual purge may be performed any time the sensor lines contain excessive condensation, moisture, or secretions.

To perform a manual purge:

1. Touch the Configure icon on the in the constant access icons area of the GUI.

2. Touch the Options tab. A screen appears containing the Installed Options and Prox tabs.

3. Touch the Prox tab. The Prox Setup screen appears.

4. Touch START that appears next to the text “Prox Manual Purge: To begin touch the Start button”. During the purge, a message appears in the GUI prompt area stating the purge process is being performed. See

Figure 119, page 307

311

Figure 123.

Manual Purge

16.11 Alarms

If the Proximal Flow option becomes inoperable during ventilation, the ventilator annunciates an alarm and flow sensing reverts to the ventilator’s internal delivery and exhalation flow sensors. This switch-over may be triggered by any of the following events:

• The proximal flow s is not detected

• Pressure and flow readings are out of range

• Hardware problems are reported by the Proximal Flow option PCBA

• There is a communication failure between the ventilator and the Proximal Flow option

If any of these conditions occur, the GUI displays an alarm message similar the one shown in Figure 124

. Follow the information contained in the remedy message to troubleshoot the alarm.

312

Figure 124.

Alarm Message — Prox Inoperative

16.12 Ranges, Resolutions, and Accuracies

See Table 66, page 256

for proximal exhaled tidal volume, proximal inspired tidal volume, proximal exhaled minute volume, and proximal flow patient data parameters.

16.12.1 Proximal Flow Sensor Specifications

Table 89.

Proximal Flow Sensor Volume Accuracy

Measurement

Exhaled tidal volume

Inspired tidal volume

± (1.0 mL +10% of reading)

Accuracy a

a The conditions under which the accuracy values apply are as follows: Sensor is used as described in this appendix or the

IFU provided with the sensor

Table 90.

Proximal Flow Sensor Specifications

Parameter

Weight

Dead space

Pressure drop

Specification

6.6 g

<1 mL

1.5 cmH

O at 10 L/min

16.13 Part Numbers

Table 91 lists the part numbers for the proximal flow option kit and individual components.

Table 91.

Proximal Flow Option and Component Part Numbers

Item

Proximal flow option kit Includes: Installation hardware and accessories

Proximal flow sensor, neonatal (package of 10)

Part number

10084331

10047078

313

Table 91.

Proximal Flow Option and Component Part Numbers (continued)

Item

NOTE: Includes three cable management clips

Proximal flow sensor module

Interconnect PCBA

Purge control cable

Purge supply line

PCBA mounting screws

Proximal Flow Option label

Part number

10087622

10083941

10083940

10083966

10083963

10005748

314

17 Appendix Trending

17.1 Overview

This appendix describes the operation of the Puritan Bennett 980 Series Ventilator Trending function.

Trending is a graphically-based ventilator function allowing a combination of a total of six patient data parameters or ventilator settings to be plotted vs. time. Viewing these data allows the clinician to determine the effectiveness of the patient’s therapy.

17.2 Intended Use

The Trending feature is intended to trend a patient’s respiratory parameters and ventilator settings over time, to aid physicians in assessing the effectiveness of current therapy. It is not intended to determine the course of treatment.

17.3 Safety Reminder

Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations, and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs.

17.4 Trending Description

Trending enables a combination of up to six patient data parameters and ventilator settings to be plotted at one time. The user can choose from one of eight time scales.

17.5 Setting Up Trending

To set up trending

1. If a patient is not already being ventilated, set up patient ventilation per the instructions given in Chapter 4

2. Swipe the Menu tab on the left side of the GUI and touch Trending.

The default layout appears with two trended parameters displayed on a 2-hour time scale. Alternatively, touch the layout icon and touch Trending on the Graphs tab. The default layout appears with two trended parameters displayed on a 2-hour time scale.

315

Figure 125.

Accessing Trending via the Menu Tab

1 Trending button appears after swiping the menu tab

3. Select the parameters to be trended by double-tapping the trended parameter name at the top of the graph or choose Presets, which automatically populates trended items with preset trended parameters. See

Section 17.8, Trending Presets, page 322

. If you desire a different layout than the two-parameter default, touch

Custom 2 and a drop-down list appears with layouts for one, two, three, four, or six parameters. Choose the trended parameters for each graph by double-tapping the parameter. A list of buttons appears with arrows to let you know more parameters may be selected. Touch the desired button for the parameter to be trended.

To exit Trending

1. Touch the layout icon, then touch any of the waveform layout buttons (1 through 5).

2. The screen will exit the Trending layout and return to displaying the selected waveforms.

17.6 Trend Parameters

Both ventilator settings and patient data parameters can be trended. Trended ventilator settings are identified with brackets around the setting. For example, if respiratory rate is chosen as a trended ventilator setting, it would appear on the GUI as [f ]. Trended patient data parameters are not bracketed. If circuit pressure were trended, its value would appear as P subject to change.

PEAK

Table 92

and

Table 93 include trended ventilator settings and parameters and are

Table 92.

Trended Ventilator Settings

Ventilator setting

Expiratory Sensitivity

Respiratory Rate

Peak Inspiratory Flow

I:E Ratio

Oxygen Percentage

Symbol

SENS

[f ]

]

[ ⩒

MAX

]

[I:E]

316

Table 92.

Trended Ventilator Settings (continued)

Ventilator setting

PEEP

High Pressure (in BiLevel)

Low Pressure (in BiLevel)

Inspiratory Pressure

Pressure Support Level

Rise Time%

Flow Sensitivity

Pressure Sensitivity

High Time (in BiLevel)

Low Time (in BiLevel)

Ratio

Inspiratory Time

Expiratory Time

Tidal Volume (in VC, VC+)

Volume Support

Percent Support—PAV

Percent Support— TC

High Spontaneous Inspiratory Time Limit

Apnea Interval

Predicted Body Weight

Alarm Volume

Expiratory Sensitivity—PAV

Tube Size

Plateau Time

Increase O

IE Sync Trigger Threshold

Tidal Volume/PBW Ratio

Support Volume per kg

Humidifier Volume

Table 93.

Trended Patient Data Parameters

Patient data parameter

Dynamic Compliance

PAV-based Lung Compliance

PAV-based Lung Elastance

End Expiratory Flow

Peak Expiratory Flow Rate

Peak Spontaneous Flow Rate

Total Respiratory Rate

I:E Ratio

Negative Inspiratory Force

317

Symbol

DYN

PAV

STAT

PAV

EEF

PSF f

TOT

I:E

NIF

Symbol

[PEEP]

]

SUPP

]

[ ]

[ ⩒

SENS

]

SENS

]

T SUPP

]

[% Supp]

[ ⤒ T

I SPONT

]

[PBW]

[Alarm Volume]

SENS PAV

]

[Tube Size]

]

SYNC

]

/PBW]

T SUPP

/PBW]

[Humid Vol]

Table 93.

Trended Patient Data Parameters (continued)

Patient data parameter

Oxygen Percentage (monitored)

Occlusion Pressure

End Expiratory Pressure

Intrinsic PEEP

PAV-based Intrinsic PEEP

Total PEEP

Mean Circuit Pressure

Peak Circuit Pressure

Plateau Pressure

Spontaneous Rapid Shallow Breathing Index

Dynamic Resistance

PAV-based Patient Resistance

PAV-based Total Airway Resistance

Driving Pressure

Spontaneous Inspiratory Time

Spontaneous Inspiratory Time Ratio

Vital Capacity

Exhaled Total Minute Volume

Exhaled Spontaneous Minute Volume

Exhaled Tidal Volume

Exhaled Spontaneous Tidal Volume

Exhaled Mandatory Tidal Volume

Inspired Tidal Volume

Work of Breathing

Percent Leak

Inspiratory Leak

Exhaled Tidal Volume per kg PBW

End Tidal CO

Compliance Ratio

Inspiratory time constant

Estimated Inspiratory volume during Leak Sync

Leak Rate at PEEP

Exhalation leak at PEEP during Leak Sync measured by the proximal flow sensor

Inspired tidal volume measured by the proximal flow sensor

Inspired tidal volume measured by the proximal flow sensor per kg PBW

Estimated inspiratory volume during Leak Sync per kg

PBW

Exhaled tidal volume measured by the proximal flow sensor

318

Symbol

0.1

PEEP

I SPONT

TOT

⩒

E TOT

⩒

E SPONT

TE SPONT

TE MAND

WOB

TOT

%LEAK

PEEP

I PAV

PEEP

MEAN

PEAK

PL f/V

DYN

STAT

TOT

DRIVE

LEAK

/PBW

ETCO

3Tau

LEAK

TIY

/PBW

TEY

Table 93.

Trended Patient Data Parameters (continued)

Patient data parameter

Exhaled tidal volume measured by the proximal flow sensor per kg PBW

Exhaled spontaneous tidal volume measured by the proximal flow sensor

Exhaled spontaneous minute volume measured by the proximal flow sensor

Exhaled mandatory tidal volume when the proximal flow sensor is enabled

Inspiratory tidal volume during Leak Sync measured by the proximal flow sensor

Estimated inspiratory volume per kg PBW during Leak

Sync measured by the proximal flow sensor

Exhaled minute volume when the proximal flow sensor is enabled

Symbol

TEY

/PBW

TE SPONTY

⩒

E SPONTY

TEY MAND

TLY

/PBW

⩒

E TOTY

17.7 Viewing Trended Parameters

The cursor plays an important role when using Trending. Use the cursor to determine the parameter value vs. time and details regarding events. Touch the cursor button and turn the knob to move the cursor. The cursor moves along the waveform with the y-axis displaying the parameter’s value and the x-axis showing the time. As the waveform changes, each value is shown surrounded by a highlighted box as the cursor hovers over the waveform.

If the cursor is at its left-most position on the graph, it remains there and the graph displays the earliest time stamp.

If the cursor is in between left- and right-most positions on the graph, the cursor tracks its time stamp as the graph moves and new data arrive.

If the cursor is at its right-most position on the graph, it remains there and the graph displays the latest time stamp.

Note: If a trend parameter is not selected for a particular graph, the minimum and maximum values appear as dashes (- -).

17.7.1 Time Scales

Eight time scales are available. Time scales of 1, 2, 4, 8, 12, 24, 48, and 72 hours can be viewed. The time scale is indicated by the slider track at the bottom of the Trending screen. The complete slider track represents a 72-hour time interval, and the blue shuttle that slides along the track represents the selected time scale. The selected time scale applies to all displayed trend graphs.

Although data are sampled at periodic intervals, as shown in Table 94

, the GUI screen is refreshed every minute for any time scale selected.

Table 94.

Sampling Periods for Selected Time Scales

Time scale

1 hour

2 hours

4 hours

8 hours

12 hours

24 hours

Sampling period

10 seconds

20 seconds

40 seconds

80 seconds

2 minutes

4 minutes

319

Table 94.

Sampling Periods for Selected Time Scales (continued)

Time scale

48 hours

72 hours

Sampling period

8 minutes

12 minutes

To select a time scale

1. Touch the x-axis of the graph. The time values are surrounded by a highlighted box, indicating the time scale is ready to be changed.

2. Turn the knob to select a time scale. Turning the knob clockwise reduces the time scale, and turning it counter-clockwise increases the time scale. The relative size of the shuttle indicates the time interval selected, and the time interval is displayed along the x-axis.

3. When finished, touch the x-axis again to dismiss the box.

After each time scale change, the graphs refresh with updated parameter values for that time scale.

17.7.2 Events

Events are either automatic or manual and appear as vertical tick marks on the trend graph according to their time of occurrence. When the cursor hovers over a tick mark, Event Details changes from unselectable (gray) to a button containing the event ID numbers associated with the tick mark. Touching this button causes a dialog to appear with the event ID and its description. If many IDs are present for a selected time stamp, the user is notified by an ellipsis (…) indicating more IDs are present.

When the operator modifies the real time clock setting, the system places an event marker in the trend log to denote a time or date change. The time stamp of this automatic event will be the new time setting.

Note:

The events listed in Table 95

are subject to change.

Table 95.

Events

Event ID Description

Manual events

Suction

Rx: Bronchodilator

Rx: Antihistamine

Rx: Steroid

Rx: Antibiotic

Rx: Muco/Proteolytic

Blood Gas

Circuit Change

Start Weaning

Stop Weaning

Bronchoscopy

X-ray

Recruitment maneuver a

Other 1

Other 2

Other 3

Surfactant administration

Prone position

320

Table 95.

Events (continued)

Event ID

Description

Supine position b

Left side position b

Right side position

Manual stimulation b

Start transport

Stop transport

Start N.O Rx

Stop N.O Rx

Automatic events

Changed ventilation type to Invasive

Changed ventilation type to NIV

Changed mode to A/C

Changed mode to SIMV

Changed mode to SPONT

Changed mode to BiLevel

Changed mandatory type to VC

Changed mandatory type to VC+

Changed mandatory type to PC

Changed spontaneous type to PS

Changed spontaneous type to VS

Changed spontaneous type to PAV+™

Changed spontaneous type to TC a

Time (real-time clock) changed by user

Same Patient selected

Occlusion

Circuit Disconnect

Apnea Ventilation

NIF Accepted

0.1

Accepted

VC Accepted

Inspiratory Pause Maneuver Completed

Expiratory Pause Maneuver Completed

Changed mode to CPAP b

Elevate O

Alarm volume change

Proximal Flow Sensor state Enabled b

Proximal Flow Sensor state Disabled b

Manual Inspiration

Leak Sync Enabled

Leak Sync Disabled

Changed trigger type to Pressure

321

Table 95.

Events (continued)

Event ID

91 a c

Not available for neonatal circuit types.

b Only for neonatal circuit types.

Adult only.

To record a manual event

1. Touch the Manual Event text below the home icon on the GUI screen.

Description

Changed trigger type to Flow

Changed trigger type to IE Sync a

Enter Stand-By Ventilation

Exit Stand-By Ventilation

Backup Ventilation

Changed humidifier type to Heated

Changed humidifier type to Non-heated

Changed humidifier type to HME

The manual event screen appears with arrows allowing scrolling through the available manual events. See

Table 9, page 37 and

Figure 32, page 94 .

2. Touch Accept to confirm the event or Cancel to cancel the action.

3. View the event by hovering the cursor over the vertical tick mark and touching Event Details which now appears as a button containing event IDs. After touching the button, a dialog appears showing the event

ID and its description.

17.8 Trending Presets

The trending function enables the clinician to view a combination of up to six patient data parameters and ventilation settings that are plotted over time on a clinician-selected time scale. There are two options for how trended values are selected for display on the trending screen:

• The clinician may select each individual trended value that is displayed on the trending screen.

• The clinician may select a trending preset (a preselected group of trended values) for display.

The ventilator offers presets for adult and pediatric patients and a different set of presets for neonatal patients. The trending presets are intended to aid clinicians in assessing the effectiveness of the current therapy but are not intended to determine the course of treatment.

17.8.1 Adult and Pediatric Trending Presets

Adult and pediatric trending presets include but are not limited to:

Weaning — f/V

, P

0.1

, NIF, [V

T SUPP

], [V

T SUPP

], C

STAT

ARDS — P

, [PEEP], V

, R

STAT

, C

STAT

, [V

]

COPD — R

DYN

, EEF, f

TOT

, V

TE SPONT

, ⩒

E TOT

, C

STAT

VC+ — P

PEAK

, V

, C

STAT

, [V

], [T

], R

STAT

PAV+™ — [% Supp], P

PEAK

, WOB

TOT

, f

TOT

, V

, R

PAV

BiLevel — C

STAT

, [P

], [P

], P

MEAN

, PEEP

, f

TOT

322

LRM — P

PEAK

, PEEP, C

DYN

, V

, C

STAT

, [T

17.8.2 Neonatal Trending Presets

Neonatal trending presets include but are not limited to:

VCV — P

PEAK

, PEEP, [V

], P

MEAN

, V

, O

PCV — P

PEAK

, V

, P

MEAN

, [T

], PEEP, O

BPD — P

PEAK

, C

DYN

, P

MEAN

, PEEP, R

DYN

, O

SURF — V

, C

DYN

, R

DYN

, P

MEAN

, [T

], O

Weaning — f

TOT

, V

, C

DYN

, R

DYN

, [f ], O

N SIMV — f

TOT

, [f ], [P

], PEEP, P

MEAN

, O

N SPONT — f

TOT

, PEEP, O

%, I:E ratio, PSF,%LEAK

Leak Sync — %LEAK, LEAK, V

LEAK

, V

, ⩒

E TOT

To select a trending preset

1. Touch Presets. A dialog appears with available choices. Arrows on the dialog indicate more available choices.

2. Touch the desired trending preset. As all trending presets include six parameters, the trend graph changes to a six-graph layout, populated with the six trended preset parameters described above. The chosen trended preset appears on the Presets button.

Note: If a trended preset is selected, it is not possible to change the trended parameters. You must first select a custom layout, by touching Custom, then double-tapping the parameters you desire to change.

17.9 Data Gaps

Data gaps are shown during Apnea ventilation, occlusion, circuit disconnect, Stand-By ventilation, and backup ventilation. Gaps also appear for trended parameters that are not applicable, such as parameters associated with a non-installed option or those that are not active in the current ventilator settings.

323

Glossary

AC, also ac – Alternating current. The movement of electrical charge that periodically reverses direction.

analysis message – A message displayed on the GUI screen during an alarm condition, identifying the root cause of the alarm.

ASCII – American Standard Code for Information Interchange. A standard character encoding scheme.

assist breath – A mandatory breath triggered by patient inspiratory effort in A/C and SIMV modes.

assist-control A/C mode – A ventilation mode where only mandatory VC, PC, or VC+breaths are delivered to the patient.

audio paused (alarm silence) – Used interchangeably with the term alarm silence, the 2-minute period that begins after the audio paused (alarm silence) key is pressed, where the audible portion of an alarm is muted.

augmented alarm – The initial cause of an alarm has precipitated one or more related alarms. When an alarm occurs, any subsequent alarm related to the cause of this initial alarm “augments” the initial alarm.

autotriggering – The ventilator delivers repeated, unintended breaths triggered by fluctuating flows or pressures as opposed to patient demand. Patient circuit leaks and low flow or pressure sensitivity settings are common causes of autotriggering.

background checks – Continuously running tests during ventilation that assess the ventilator’s electronics and pneumatics hardware.

backup ventilation (BUV) – A safety net feature which is invoked if a system fault in the mix subsystem, inspiratory subsystem, or expiratory subsystem occurs compromising the ventilator’s ability to ventilate the patient as set.

base flow – A constant flow of gas through the patient circuit during the latter part of exhalation during flow triggering (V sensitivity.

TRIG

). The value of this base flow is 1.5 L/min greater than the operator selected value for flow base message – A message given by the ventilator during an alarm condition, identifying the alarm.

batch changes – Changes to multiple settings that go into effect at the same time.

battery back-up system – The system for supplying battery back-up power to a device. The ventilator’s battery back-up system consists of a single primary battery to provide up to one (1) hour of battery power to the ventilator.

An optional extended battery with the same characteristics as the primary battery is available.

BD, BDU – Breath delivery or breath delivery unit. The ventilator component that includes inspiratory and expiratory pneumatics and electronics.

BiLevel mode – A mixed ventilation mode combining mandatory and spontaneous breaths, where two levels of pressure are delivered (P

and P

) corresponding to expiratory and inspiratory times T

L and T

BOC – British Oxygen Company. A standard for high pressure gas inlet fittings.

breath stacking – The delivery of a second inspiration before the first exhalation is complete.

BTPS – Body temperature and pressure, saturated, 37°C, at ambient barometric pressure, at 100% relative humidity.

CE – A certification mark issued under the authority of the European Common Market that indicates compliance with the Medical Device Directive, 93/42/EEC.

cm – Centimeter. A unit of length.

cmH

O – Centimeters of water. A unit of pressure approximately equal to 1 hPa.

324

17 compliance volume – The volume of gas that remains in the patient circuit and does not enter the patient’s respiratory system.

compressor – The compressor provides compressed air, which can be used in place of wall or bottled air.

constant during rate change – One of three breath timing variables (inspiratory time, I:E ratio, or expiratory time) the operator can hold constant when the respiratory rate setting changes. Applies only to the pressure control

(PC) mandatory breath type (including VC+ and BiLevel).

control breath – A ventilator-initiated mandatory breath delivered in A/C mode.

CPU – Central processing unit. The electronic components of the ventilator (BD and GUI) responsible for interpreting and executing instructions entered by the operator.

CRC – Cyclic Redundancy Check or Code. An algorithm or a computational result based on the remainder of a division defined over the ring of polynomials in the Galois field GF(2). CRC algorithms are the basis for data integrity checks.

CSA – Canadian Standards Association.

SENS

– Disconnect sensitivity. A setting that specifies the allowable loss (percentage) of delivered tidal volume, which if equaled or exceeded, causes the ventilator to declare a DISCONNECT alarm. The greater the setting, the more returned volume must be lost before DISCONNECT is detected. If the Leak Sync option is in use, D

SENS maximum allowable leak rate and is expressed in terms of L/min.

is the

DC, also dc – Direct current. The movement of electrical charge flowing in a single direction.

dependent alarm – An alarm that arises as a result of another primary alarm (also referred to as an augmentation).

DISS – Diameter index safety standard. A standard for high pressure gas inlet fittings.

SENS

– Expiratory sensitivity. A setting that determines the percent of peak inspiratory flow (or flow rate expressed in L/min in a PAV breath) at which the ventilator cycles from inspiration to exhalation for spontaneous breaths. Low settings will result in longer spontaneous inspirations.

EMC – Electromagnetic compatibility.

EN – European norm (referring to the European Common Market).

EST – Extended self test. A comprehensive test of ventilator function, intended to be run by qualified service personnel.

ETO – Ethylene oxide.

EVQ – The exhalation flow sensor assembly.

exhalation valve (EV) – The valve in the expiratory limb of the ventilator breathing system that controls PEEP.

expiratory pause – An operator-initiated maneuver that closes the inspiration (proportional solenoid) and exhalation valves during the exhalation phase of a mandatory breath. The maneuver can be used to determine intrinsic (auto) PEEP (PEEP

f, f

TOT

– Respiratory rate, as a setting () in A/C, SIMV, and BiLevel the minimum number of mandatory breaths the patient receives per minute. As a monitored value (f

TOT patient.

), the average total number of breaths delivered to the f/V

– Tidal volume. A setting that determines the volume inspired and expired with each breath. The f/V the patient during a mandatory, volume-based breath. f/V

T temperature and pressure, saturated (BTPS).

T delivered by some Puritan Bennett ventilators is an operator-set variable that determines the volume delivered to

is compliance-compensated and corrected to body

FAILURE – A category of condition detected during SST or EST that causes the ventilator to enter the safety valve open state. A ventilator experiencing a FAILURE requires removal from clinical use and immediate service.

325

flow pattern – A setting that determines the gas flow pattern of mandatory volume-controlled breaths.

ft – Feet. A unit of length.

gold standard test circuit – Test circuit designed for use with EST.

GUI – Graphical user interface. The ventilator’s touch screen used to enter patient settings and alarm settings, including off-screen keys, soft keys, and knobs.

hard bound – A ventilator setting that has reached its minimum or maximum limit.

high-priority alarm – As defined by international standards organizations, an alarm that requires immediate attention to ensure patient safety. When a high-priority alarm is active, the red high-priority LED indicator flashes and the high-priority audible alarm sounds (a repeating sequence of five tones that repeats twice, pauses, then repeats again), and the alarm banner on the GUI screen shows an alarm message with the ( !!! ) symbol.

HME – Heat-moisture exchanger. A humidification device, also called an artificial nose.

hPa – Hectopascal. A unit of pressure, approximately equal to 1 cmH

O humidification type – A setting for the type of humidification system (HME, non-heated expiratory tube, or heated expiratory tubing) in use on the ventilator.

Hz – Hertz. A unit of frequency, indicating cycles per second.

I:E ratio – The ratio of inspiratory time to expiratory time. Also, the operator- set timing variable that applies to PC and VC+ mandatory breaths.

IEC – International Electrotechnical Commission. A standards organization.

inspiratory pause – An operator-initiated maneuver that closes the inspiration (proportional solenoid) and exhalation valves at the end of the inspiratory phase of a mandatory breath. The maneuver can be used to determine static compliance (C

STAT

) and static resistance (R

STAT

invasive ventilation – Patient ventilation while intubated with an endotracheal (or tracheostomy) tube.

ISO – International Standards Organization. A standards organization.

kg – Kilogram. A unit of weight.

kPa – Kilopascal. A unit of pressure approximately equal to 10 cmH

L – Liter. A unit of volume.

L/min – An alarm whose visual alarm indicator remains illuminated after the alarm has autoreset.

latched alarm – An alarm whose visual alarm indicator remains illuminated after the alarm has autoreset.

lb – Pound. A unit of weight.

LCD – Liquid crystal display. A type of visual equipment-operator Interface.

LED – Light-emitting diode. A means of providing visual indications.

lockable alarm – An alarm that does not terminate an active alarm silence function.

low-priority alarm – As defined by international standards organizations, an alarm that indicates a change in the patient-ventilator system. During a low-priority alarm, the yellow low-priority LED indicator lights, the low-priority audible alarm (one tone) sounds, and the GUI screen shows an alarm banner with the ( ! ) symbol.

m – Meter. A unit of length.

maintenance – All actions necessary to keep equipment in, or restore it to, serviceable condition. Includes cleaning, servicing, repair, modification, overhaul, inspection, and performance verification.

mandatory breath – A breath whose settings and timing are preset; can be triggered by the ventilator, patient, or operator.

326

17 mandatory type – The type of mandatory breath: volume control (VC), VC+ or pressure control (PC).

manual inspiration – An operator-initiated mandatory (OIM) breath.

medium-priority alarm – As defined by international standards organizations, an abnormal condition that requires prompt attention to ensure the safety of the patient. When a medium-priority alarm is active, the yellow medium-priority LED indicator flashes, the medium- priority audible alarm (a repeating sequence of three tones) sounds, and the GUI screen shows an alarm banner with the ( !! ) symbol.

mL – Milliliter. A unit of volume.

mode – Ventilatory mode. The algorithm that determines type and sequence of breath delivery.

MRI – Magnetic resonance imaging.

ms – Millisecond. A unit of time.

NIST – Non-interchangeable screw thread. A standard for high pressure gas inlet fittings.

non-invasive ventilation (NIV) – Patient ventilation without the use of an endotracheal tube; instead using interfaces such as masks, nasal prongs, or uncuffed endotracheal tubes.

non-technical alarm – An alarm caused due to a fault in the patient-ventilator interaction or a fault in the electrical or gas supplies that the practitioner may be able to alleviate.

normal ventilation – The state of the ventilator when breathing is in progress and no alarms are active.

NVRAM, also NovRam – Non-volatile random access memory. Memory that is kept active across resets and power cycles and is not normally initialized at startup.

% – Both a ventilator setting and a monitored variable. The O

2 in the delivered gas. The O

% setting determines the percentage of oxygen

% monitored data is the percentage of oxygen in the gas delivered to the patient, measured at the ventilator outlet upstream of the inspiratory filter.

OIM – Operator-initiated mandatory breath. A breath delivered when the operator presses the MANUAL INSP key.

ongoing background checks – Continuously running tests during ventilation that assess the ventilator’s electronics and pneumatics hardware.

OSC – Occlusion status cycling. A ventilation mode in effect during a severe occlusion. In this mode, the ventilator periodically attempts to deliver a pressure-based breath while monitoring the inspiration and expiration phases for the continuing existence of the occlusion.</para>

OVERRIDDEN – The final status of an SST or EST run in which the operator used the override feature. (The ventilator must have ended the test with an ALERT condition.)

– Inspiratory pressure. The operator-set inspiratory pressure at the patient wye (above PEEP) during a pressure control (PC) mandatory breath.

L at-time – Plateau time. The amount of time the inspiration phase of a mandatory breath is extended after inspiratory flow has ceased and exhalation is blocked. Increases the residence time of gas in the patient’s lungs.

MEAN

– Mean circuit pressure, a calculation of the measured average patient circuit pressure over an entire respiratory cycle.

PEAK

– Maximum circuit pressure, the maximum pressure during the inspiratory and expiratory phases of a breath.

SENS

– Pressure sensitivity. The operator-set pressure drop below PEEP (derived from the patient’s inspiratory flow) required to begin a patient-initiated breath when pressure triggering is selected.

SUPP

– Pressure support. A setting of the level of inspiratory assist pressure (above PEEP) at the patient wye during a spontaneous breath (when spontaneous breath type is PS).

327

TRIG

– Pressure triggering, a method of recognizing patient inspiratory effort in which the ventilator monitors pressure in the patient circuit. The ventilator triggers a breath when the airway pressure drops by at least the value selected for pressure sensitivity (P

SENS

) patient circuit – The entire inspiratory-expiratory conduit, including tubing, humidifier, and water traps.

patient data alarm – An alarm condition associated with an abnormal condition of the patient’s respiratory status.

patient problems – A definition used by the ventilator’s safety net. Patient problems are declared when patient data are measured equal to or outside of alarm thresholds and are usually self-correcting or can be corrected by a practitioner. The alarm monitoring system detects and announces patient problems. Patient problems do not compromise the ventilator’s performance.

PBW – Predicted body weight, a ventilator setting that specifies the patient’s body weight assuming normal fat and fluid levels. Determines absolute limits on tidal volume and peak flow, and allows appropriate matching of ventilator settings to the patient.

PC – Pressure control. A mandatory breath type in which the ventilator delivers an operator-set inspiratory pressure for an operator- set inspiratory time. Available in A/C and SIMV modes, and for operator-initiated mandatory (OIM) breaths in SPONT mode.

PE – Expiratory pressure transducer.

PEEP – Positive end expiratory pressure. The measured circuit pressure (referenced to the patient wye) at the end of the expiratory phase of a breath. If expiratory pause is active, the displayed value reflects the level of any active lung PEEP.

PEEPI – Intrinsic PEEP. Indicates a calculated estimate of the pressure above the PEEP level at the end of exhalation.

Determined during an expiratory pause maneuver.

PI – Inspiratory pressure transducer.

I END

– End inspiratory pressure. The pressure at the end of the inspiration phase of the current breath. If plateau is active, the displayed value reflects the level of end-plateau pressure.

PIM – Patient-initiated mandatory breath. A mandatory breath triggered by patient inspiratory effort.

POST – Power-on self-test. Software algorithms to verify the integrity of application software and the hardware environment. Power-on self-test generally occurs at power on, after power loss, or when the device detects an internal fault.

primary alarm – An initial alarm.

PS – Pressure support, a spontaneous breath type in which the ventilator delivers an operator-set pressure (in addition to PEEP) during the inspiratory phase. Available in SPONT, SIMV, and BiLevel modes.

PSOL – Proportional solenoid valve.

RAM – Random access memory.

remedy message – A message displayed on the GUI during an alarm condition suggesting ways to resolve the alarm.

resistance – The flow-dependent pressure drop across a conduit. Measured in cmH

O/L/s or hPa/L/s.

restricted phase of exhalation – The time period during the exhalation phase where an inspiration trigger is not allowed. The restricted phase of exhalation is defined as the first 200of exhalation, OR the time it takes for expiratory flow to drop to ≤ 50% of the peak expiratory flow, OR the time it takes for the expiratory flow to drop to

≤ 0.5 O

% (whichever is longest). The restricted phase of exhalation will end after five (5) seconds of exhalation have elapsed regardless of the measured expiratory flow rate.

328

17 rise time % – A setting that determines the rise time to achieve the set inspiratory pressure in pressure-controlled

(PC), VC+ BiLevel, or pressure-supported (PS) breaths. The larger the value, the more aggressive the rise of pressure.

s – Second. A unit of time.

safety net – The ventilator’s strategy for responding to patient problems and system faults.

safety valve (SV) – A valve residing in the ventilator’s inspiratory module designed to limit pressure in the patient circuit. When open, it allows the patient to breathe room air if able to do so.

safety ventilation – A mode of ventilation active if the patient circuit is connected before ventilator startup is complete, or when power is restored after a loss of five (5) minutes or more.

service mode – A ventilator mode providing a set of services tailored to the needs of testing and maintenance personnel. When in the service mode, the ventilator does not provide ventilation.

SIMV – Synchronous intermittent mandatory ventilation. A ventilatory mode in which the ventilator delivers one mandatory breath per breath cycle and as many spontaneous breaths as the patient can trigger during the remainder of the breath cycle.

SIS – Sleeved index system. A standard for high pressure gas inlet fittings.

soft bound – A ventilator setting that has reached its recommended high or low limit, accompanied by an audible tone. Setting the ventilator beyond this limit requires the operator to acknowledge a visual prompt to continue.

SPONT – Spontaneous. A ventilatory mode in which the ventilator delivers only spontaneous breaths. In SPONT mode, the patient triggers all breaths delivered by the ventilator with no set mandatory respiratory rate. The patient controls the breath variables, potentially augmented by support pressure.

spontaneous type – A setting that determines whether spontaneous breaths are pressure-supported (PS), tube-compensated (TC), volume-supported (VS), or proportionally assisted (PAV).

SST – Short self test. A test that checks circuit integrity, calculates circuit compliance and filter resistance, and checks ventilator function. Operator should run SST at specified intervals and with any replacement or alteration of the patient circuit.

STPD – Standard temperature and pressure, dry. Defined as dry gas at a standard atmosphere (760 mmHg,

101.333 kPa, approximately 1.0 bar) and 0°C.

SVO – Safety valve open. An emergency state in which the ventilator opens the safety valve so the patient can breathe room air unassisted by the ventilator if able to do so. An SVO state does not necessarily indicate a ventilator inoperative condition. The ventilator enters an SVO state if a hardware or software failure occurs that could compromise safe ventilation, with the loss of the air and oxygen supplies, or if the system detects an occlusion.

system fault – A definition used by the ventilator’s safety net. System faults include hardware faults (those that originate inside the ventilator and affect its performance), soft faults (faults momentarily introduced into the ventilator that interfere with normal operation), inadequate supply (AC power or external gas pressure), and patient circuit integrity (blocked or disconnected circuit).

– Apnea interval, the operator-set variable that defines the breath-to-breath interval which, if exceeded, causes the ventilator to declare apnea and enter apnea ventilation.

– Expiratory time. The expiratory interval of a breath. Also the operator-set timing variable that determines the expiratory period for pressure-controlled (PC) or VC+ mandatory breaths.

– Inspiratory time, the inspiratory interval of a breath. Also, the operator-set timing variable that determines the inspiratory interval for pressure-controlled (PC) or VC+ mandatory breaths.

Tb – Breath time cycle during mechanical ventilation.

technical alarm – An alarm occurring due to a violation of any of the ventilator’s self monitoring conditions, or detected by background checks.

329

Tm – Mandatory interval portion of SIMV breath cycle; it is reserved for a PIM.

Ts – Spontaneous interval portion of SIMV breath cycle; it is reserved for spontaneous breathing throughout the remainder of the breath cycle.

V – Volts. A unit of voltage.

VA – Volt-amperes. A unit of power.

VBS – Ventilator breathing system. Includes the gas delivery components of the ventilator the patient circuit with tubing, filters, humidifier, and other accessories; and the ventilator’s expiratory metering and measurement components.

VC – Volume control, a mandatory breath type in which the ventilator delivers an operator-set tidal volume, peak flow, and flow pattern. Available in A/C and SIMV modes, and for operator-initiated mandatory (OIM) breaths in

SPONT mode.

Ventilation Assurance – A safety net feature which is invoked if a system fault in the mix subsystem, inspiratory subsystem, or expiratory subsystem occurs compromising the ventilator’s ability to ventilate the patient as set.

Ventilator Inoperative (vent inop) – An emergency state the ventilator enters if it detects a hardware failure or a critical software error which could compromise safe ventilation. During a ventilator inoperative condition, the safety valve opens to allow the patient to breathe room air unassisted by the ventilator if able to do so. Qualified service personnel must power up the ventilator and run EST before normal ventilation can resume.

VIM – Ventilator-initiated mandatory breath. A breath that is delivered at a time determined by the ventilator.

⩒

E TOT

– Minute volume, the expiratory tidal volume normalized to unit time (L/min). The displayed value is compliance- and BTPS-compensated.

⩒

MAX

– Peak flow. A setting of the peak (maximum) flow of gas delivered during a VC mandatory breath.

(Combined with tidal volume, flow pattern, and plateau, constant peak flow defines the inspiratory time.) To correct for compliance volume, the ventilator automatically increases the peak flow.

⩒

SENS

– Flow sensitivity. A setting that determines the rate of flow inspired by the patient that triggers the ventilator to deliver a mandatory or spontaneous breath (when flow triggering is selected).

⩒

TRIG

– Flow triggering. A method of recognizing patient inspiratory effort in which the ventilator monitors the difference between inspiratory and expiratory flow measurements. The ventilator triggers a breath when the difference between inspiratory and expiratory flows increases to a value that is at least the value selected for flow sensitivity (V

SENS

330