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Operator’s Manual
Puritan Bennett
TM
980 Series Ventilator
Copyright Information
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.
© 2013, 2015, 2018, 2019 COVIDIEN.
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.
1 Introduction
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Warnings Regarding Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Warnings Regarding Ventilator Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Warnings Regarding Hoses, Tubing, and Accessories . . . . . . . . . . . . . . . . 1-8
1.3.11 Warnings Regarding Ventilator Maintenance . . . . . . . . . . . . . . . . . . . . . . . 1-11
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
i
ii
Mounting Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
GUI Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
How to Assemble Ventilator Components . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Connecting the Ventilator to AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
How to Install Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Ventilator Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Product Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
User Interface Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Using Gestures When Operating the GUI . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Constant Timing Variable During Rate Changes . . . . . . . . . . . . . . . . . . . . 4-17
Predicted Body Weight (PBW) Calculation . . . . . . . . . . . . . . . . . . . 4-18
Non-invasive Ventilation (NIV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Conversion from INVASIVE to NIV Vent Type . . . . . . . . . . . . . . . . . . . . . . . 4-20
Conversion from NIV to INVASIVE Vent Type . . . . . . . . . . . . . . . . . . . . . . . 4-22
High Spontaneous Inspiratory Time Limit Setting . . . . . . . . . . . . . . . . . . 4-22
Respiratory Mechanics Maneuvers . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
iii
iv
Oxygen Sensor Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Ventilator Protection Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Ventilator Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
Communication Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Display Configurability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Printing Data or Screen Captures . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Connectivity to External Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
2
% Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
6.5.16 HIGH EXHALED MINUTE VOLUME Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
2
% Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
6.5.23 LOW EXHALED MANDATORY TIDAL VOLUME Alarm . . . . . . . . . . . . . . . 6-34
6.5.24 LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm . . . . . . . . . . . . . 6-35
6.5.25 LOW EXHALED TOTAL MINUTE VOLUME Alarm . . . . . . . . . . . . . . . . . . . . 6-35
Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Exhaled Spontaneous Minute Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
v
vi
6.6.25 Spontaneous Rapid Shallow Breathing Index . . . . . . . . . . . . . . . . . . . . . . 6-40
/C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
Ventilator Operational Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . .7-4
Component Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . .7-5
Exhalation Flow Sensor Assembly (EVQ) Disinfection . . . . . . . . . . . . . . . . 7-8
Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Service Personnel Preventive Maintenance . . . . . . . . . . . . . . . . . 7-19
Inspection and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Storage for Extended Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
How to Obtain Ventilator Service
General Accessory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Applicable Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Inspiration — Detection and initiation . . . . . . . . . . . . . . . . . . . . . . 10-4
Exhalation — Detection and Initiation . . . . . . . . . . . . . . . . . . . . . . 10-7
Compliance and BTPS Compensation . . . . . . . . . . . . . . . . . . . . . . 10-10
10.6.1 Compliance Compensation in Volume-based Breaths . . . . . . . . . . . . . 10-10
10.6.2 BTPS Compensation in Volume-based Breaths . . . . . . . . . . . . . . . . . . . . 10-13
Mandatory Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13
vii
viii
Spontaneous Breath Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Spontaneous (SPONT) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-32
10.12.3 Settings Changes During Apnea Ventilation . . . . . . . . . . . . . . . . . . . . . . 10-35
Detecting Occlusion and Disconnect . . . . . . . . . . . . . . . . . . . . . . . 10-37
10.13.3 Annunciating Occlusion and Disconnect Alarms . . . . . . . . . . . . . . . . . .10-40
Respiratory Mechanics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
Maneuver (Occlusion Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
10.15.2 Circuit Type and Predicted Body Weight (PBW) . . . . . . . . . . . . . . . . . . . 10-47
H
:T
L
Ratio in BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-63
Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64
Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Interface Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
ix
x
Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27
Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-29
Essential Performance Requirements . . . . . . . . . . . . . . . . . . . . . . 11-36
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Using Pressure Support with BiLevel . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Manual Inspirations in BiLevel Mode . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Respiratory Mechanics Maneuvers in BiLevel . . . . . . . . . . . . . . . . . A-5
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
When Leak Sync is Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3
Adjusting Disconnect Sensitivity (D
) . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
) Accuracy During Leak Sync . . . . . . . . . . . . . B-7
TE
) Accuracy During Leak Sync . . . . . . . . . . . . . . B-7
Circuit Disconnect Alarm During Leak Sync . . . . . . . . . . . . . . . . . . . . . . . . . B-7
Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1
Ventilator Settings/Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-9
Proximal Flow Option Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Software/Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Sensor Calibration and Sensor Line Purging . . . . . . . . . . . . . . . . . . . E-7
Attaching the Proximal Flow Sensor for SST . . . . . . . . . . . . . . . . . . . . . . . . . E-9
Disabling/Enabling the Proximal Flow Option . . . . . . . . . . . . . . . .E-10
Using the Proximal Flow Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-11
Ranges, Resolutions, and Accuracies . . . . . . . . . . . . . . . . . . . . . . . . .E-14
xi
xii
List of Tables
Table 1-1. Shipping Carton Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . 1-2
Table 2-2. BDU Front Label Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . 2-8
Table 2-3. BDU Rear Label or Panel Symbols and Descriptions . . . . . . . . . . . . . . 2-9
Table 2-4. Common Symbols found on GUI or BDU Labels . . . . . . . . . . . . . . . .2-11
Table 3-4. Humidifier Volumes for Adult and Pediatric Patients . . . . . . . . . . . .3-42
Table 3-5. Humidifier Volumes for Neonatal Patients . . . . . . . . . . . . . . . . . . . . . .3-42
Table 6-6. Non-Technical Alarms and Suggested Responses . . . . . . . . . . . . . . .6-25
Table 7-1. Operator Preventive Maintenance Frequency. . . . . . . . . . . . . . . . . . . . 7-2
Table 7-3. Component Cleaning Agents and Disinfection Procedures . . . . . . 7-6
Table 7-6. Service Preventive Maintenance Frequency. . . . . . . . . . . . . . . . . . . . .7-19
xiii
xiv
Table 10-3. Spontaneous Breath Delivery Characteristics. . . . . . . . . . . . . . . . . . 10-19
Based on Circuit Type . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-48
Table 10-7. Peak Flow and Circuit Type (Leak Sync Disabled). . . . . . . . . . . . . . 10-48
Table 11-1. Performance Verification Equipment Uncertainty . . . . . . . . . . . . . . .11-2
Table 11-9. Ventilator Settings Range and Resolution . . . . . . . . . . . . . . . . . . . . . .11-9
Table 11-17. Immunity to Proximity Fields RF Wireless Communications
Table 11-19. Recommended Separation Distances for RF . . . . . . . . . . . . . . . . . 11-34
Table B-2. Maximum Leak Compensation Flow Based on Patient Type. . . . . . B-2
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5
Table E-4. Proximal Flow Sensor Volume Accuracy . . . . . . . . . . . . . . . . . . . . . . . .E-15
Table E-6. Proximal Flow Option and Component Part Numbers . . . . . . . . . .E-15
xv
Page Left Intentionally Blank xvi
List of Figures
Figure 2-10. Sample Status Display During Normal Ventilation . . . . . . . . . . . . . . .2-26
Figure 2-11. Pneumatic Diagram (Compressor Shown) . . . . . . . . . . . . . . . . . . . . . .2-35
Figure 2-12. Pneumatic Diagram — Compressor and Prox Flow Systems . . . .2-37
Figure 3-1. Example of Freestanding Ventilator Placement . . . . . . . . . . . . . . . . . . 3-4
Figure 3-3. Connecting the Ventilator to the Gas Supplies . . . . . . . . . . . . . . . . . . . 3-7
Figure 3-7. Connecting the Adult or Pediatric Patient Circuit . . . . . . . . . . . . . . .3-14
Figure 4-9. Vent Setup Button “NIV” Indicating NIV vent type . . . . . . . . . . . . . . .4-22
T
I SPONT
Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23
Figure 4-14. More Settings Screen with O
Sensor Enabled . . . . . . . . . . . . . . . . . .4-29
xvii
xviii
Figure 10-3. Breath Activity During Time-triggered Inspiration . . . . . . . . . . . . . . .10-7
Figure 10-4. Exhalation via the Airway Pressure Method . . . . . . . . . . . . . . . . . . . . .10-8
Figure 10-5. Exhalation via the Percent Peak Flow Method. . . . . . . . . . . . . . . . . . .10-9
Figure 10-8. Ideal Waveform Using Square Flow Pattern . . . . . . . . . . . . . . . . . . . 10-14
Figure 10-9. Ideal Waveform Using Descending Ramp Flow Pattern . . . . . . . 10-15
Figure 10-10. Ideal Waveform Using Pressure Control Ventilation . . . . . . . . . . . 10-16
Figure 10-12. Tracheostomy Tube Target Pressure vs. Flow . . . . . . . . . . . . . . . . . 10-25
Figure 10-18. PIM Not Delivered Within Mandatory Interval . . . . . . . . . . . . . . . . . 10-29
Figure 10-20. Apnea Interval Greater Than Breath Period. . . . . . . . . . . . . . . . . . . . 10-34
Figure A-1. Spontaneous Breathing at P
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
Figure A-5. Spontaneous and Synchronous Intervals . . . . . . . . . . . . . . . . . . . . . . . .A-7
Figure A-6. APRV With Spontaneous Breathing at P
H
. . . . . . . . . . . . . . . . . . . . . . . .A-8
Figure E-2. Sample GUI screen Showing Proximal Flow Data . . . . . . . . . . . . . . . . E-6
Figure E-3. Message During Autozero and Purge Processes . . . . . . . . . . . . . . . . . E-8
Figure E-4. Attaching Proximal Flow Sensor to Ventilator . . . . . . . . . . . . . . . . . . .E-10
xix
Page Left Intentionally Blank xx
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 Covidientrained 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
1-1
Introduction
1.2
Global Symbol Definitions
The following table describes the symbols shown on the ventilator shipping cartons. Other
symbols appearing on various labels are shown in Chapter 2 .
Symbol
Table 1-1. Shipping Carton Symbols and Descriptions
Description
CE Mark 0123: Signifies compliance with Medical Device Directive 93/42/
EEC
Serial number
Part number
Authorized representative
Manufacturer
This side up
Fragile
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 (-68°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.
1-2 Operator’s Manual
Safety Information
Symbol
Table 1-1. Shipping Carton Symbols and Descriptions (Continued)
Description
This device is for sale by or on the order of a physician.
Refer to instruction manual.
1.3
Safety Information
1.3.1
Safety Symbol Definitions
This section contains safety information for users, who should always exercise appropriate caution while using the ventilator.
Symbol
Table 1-2. Safety Symbol Definitions
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, and/or heaters). Oxygen-rich environments accelerate combustibility.
Operator’s Manual 1-3
1-4
Introduction
WARNING:
In case of fire or a burning smell, immediately take the following 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.
Operator’s Manual
Safety Information
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
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/or 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 qualified service personnel.
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, in order to minimize risk of phthalate exposure in children and nursing or pregnant women, this product should only be used as directed.
Operator’s Manual 1-5
1-6
Introduction
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/or 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.
Operator’s Manual
Safety Information
WARNING:
To avoid the risk of ventilator malfunction, operate the ventilator in an environment that meets
specifications. Reference Environmental Specifications , p. 11-8.
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.
Reference To run SST , p. 3-40.
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 the Ventilator Settings, Alarm Settings, and Patient Data tables in
are applicable under specified operating conditions. Reference Environmental
Specifications , p. 11-8. 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-branded batteries, adapters, and cables.
•
Do not use batteries, adapters or cables with visible signs of damage.
•
Do not touch internal components.
•
Operator’s Manual 1-7
1-8
Introduction
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 the ventilator can change the pressure gradient across the ventilator breathing system (VBS) and affect ventilator performance. Ensure that any changes to the ventilator circuit configurations do not exceed the specified values for circuit compliance and for
accessories to the patient circuit, always run SST to establish circuit compliance and resistance prior to ventilating the patient.
Operator’s Manual
Safety Information
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
2
%, delivered tidal volumes, and breath triggering. Additionally, aerosolized particulates in the ventilator circuit can lead to an increase in exhalation filter resistance.
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. Reference Accessories and Options , p. 9-3 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
Covidien 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.
Operator’s Manual 1-9
Introduction
1.3.9
Warnings Regarding Gas Sources
WARNING:
Do not use nitric oxide, helium or mixtures containing helium with the ventilator. It has not been validated for use with these gas mixtures.
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 and/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. Reference Environmental Specifications , p. 11-8 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.
1-10 Operator’s Manual
Safety Information
Follow manufacturer’s instructions for individual cleaning solutions. Reference Chapter 7
of this manual.
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 re-processing 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 Covidien-provided training for the maintenance of this ventilator.
WARNING:
Follow preventive maintenance according to specified intervals.
, p. 7-2. Reference Service Preventive Maintenance Frequency , p. 7-19.
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. Reference Surface Cleaning Agents , p. 7-5.
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.
Operator’s Manual 1-11
Introduction
Caution:
Use only the cleaning agents specified.
Reference Surface Cleaning Agents , p. 7-5. for approved cleaning agents.
Caution:
Clean compressor inlet filter according to the interval listed in Chapter 7
Preventive Maintenance Frequency , p. 7-2.
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 mask.
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
2
control. Reference To adjust the amount of elevated
O2 delivered for two minutes , p. 3-34.
1-12 Operator’s Manual
Obtaining Technical Assistance
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. Reference the following table 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 qualified, factory-trained personnel.
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 qualified, factorytrained service personnel, 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.
The following table lists Covidien Service Centers, addresses, telephone, and Fax numbers:
Covidien Argentina
Aguero 351
Capital Federal - 1171
ABC, Argentina
Tel: (5411) 4863-5300
Fax: (5411) 4863-4142
Covidien Asia
Singapore Regional
Service Centre
15 Pioneer Hub, #06-04
Singapore 627753
Tel (65) 6578 5288
Fax (65) 6515 5260
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 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 Australia
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
Canada
Tel:1-514-695-1220,
Select Option 2
Fax: 1-514-695-4965
Covidien Austria GmbH
Campus21
Europaring F09402
Brunn am Gebrige
A-2345 Österreich
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 Costa Rica
Global Park, Parkway 50
La Auroa de Heredia
Costa Rica
Tel: (506) 2239 - 5386
Fax: (506) 2239 - 5319
Covidien ECE
Prosecká 851/64
190 00 Prague
Czech Republic
Tel +42 024 109 57 35
Fax + 42 02 3900 0437
Operator’s Manual 1-13
Introduction
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 80
00
Fax +33 (0) 130 79 80
30
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,
Seocho-Gu
Seoul, Korea
Tel: +822 570 5459
Fax: +822 570 5499
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 Deutschland
GmbH
Gewerbepark 1r
D-93333 Neustadt/
Donau
Germany
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 5
4187 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 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 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 Budapest
Hungary
Tel + 36 1880 7975
Fax + 36 1777 4932
Covidien Mexico
Insurgentes Sur # 863,
Piso 16
Col. Nápoles
Del. Benito Juarez
Mexico, D.F. 03810
Mexico
Tel: (5255) 5804-1524Fax:
(5255) 5536-1326
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 Nederland BV
Hogeweg 105
NL5301 LL
ZaltbommelNederland
Tel0418 57 66 00
Fax 0418 57 67 91
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 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
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
RandjesparkMidrand,
South Africa
Tel +27 115 429 500
Fax +27 115 429 624
1-14 Operator’s Manual
Obtaining Technical Assistance
Covidien Spain S.L.
c/Fructuós Gelabert
6, 8 a
Planta
08970 Sant JoanDespí
Barcelona, Spain
Tel +34 93475 86 10
Fax +34 93 477 10 17
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 Switzerland
Roosstrasse 53
Ch-8832 Wollerau
Switzerland
Tel +41(0)44 786 50 50
Fax +41 (0) 44 78650 10
Covidien Thailand
319 Chamchuri Square
17th Floor, Unit 1-8,
Phayathai 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
Kingdom
Tel +44 (0) 1329
2240002
Fax +44 (0) 1329 220213
Covidien USA
2101 Faraday Ave
Carlsbad, 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, seven 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 below to access and use on-screen help.
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 s , 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 five (5) s
Note:
• Dragging the help icon causes the tooltip to display in its unexpanded state.
Operator’s Manual 1-15
Introduction
• 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.
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 Sensor options.
1.5
Warranty Information
To obtain warranty information, for a covered product, contact Covidien Technical Services at
1.800.255.6774 or call a local Covidien 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 option(s) 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.
1-16 Operator’s Manual
Electromagnetic Compatibility
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 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 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
in this manual.
Operator’s Manual 1-17
Introduction
Page Left Intentionally Blank
1-18 Operator’s Manual
2 Product Overview
2.1
Overview
This chapter contains introductory information for the Puritan Bennett™ 980 Series Ventilator.
Note:
Items shown in bold-italic font are contained as entries in the glossary.
Communication between the ventilator’s graphical user interface (GUI) and the breath delivery unit ( BDU ) occurs continuously via independent central processing units (CPUs) .
Reference Pneumatic Diagram (Compressor Shown) , p. 2-35 and its associated reference desig-
nators 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 ( V
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 ( V
SENS
) , the ventilator
2-1
2-2
Product Overview 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 V
SENS
setting or enable Leak Sync, if available.
Note:
Leak Sync is a software option. Details on its operation are provided in the Leak Sync appendix in this manual.
A backup pressure triggering threshold of 2 cmH
2
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 exhalation 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
2
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 320 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, reference the
NeoMode 2.0 appendix in this manual.
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:
Operator’s Manual
Indications For Use
•
•
•
•
•
•
•
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)
Reference BDU Rear Label or Panel Symbols and Descriptions , p. 2-9 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
•
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 for the ventilator system
Hospital Use — Typically covers areas such as general care floors (GCFs), operating rooms, special procedure areas, intensive and critical care areas within the hospital and in hospital-type facilities. Hospitaltype facilities include physician office-base facilities, sleep labs, 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.
Operator’s Manual 2-3
2-4
Product Overview
2.4
Contraindications
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.
2.5
Components List
Note:
No parts of the ventilator system contain 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.
1
1
1
1
1
1
2
1
1
1
Quantity
1
1
1
Table 2-1. 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)
Operator’s Manual
2.6
Product Views
2.6.1
GUI Front View
Figure 2-1. GUI Front View
Product Views
Operator’s Manual
1
2
3
4
Display brightness key
Display lock key
Alarm volume key
Manual Inspiration key
6 Inspiratory pause key
7 Expiratory pause key
8 Alarm reset key
9
Audio paused
1
key
5 Rotary encoder (knob) 10
1.
The terms “audio paused” and “alarm silence” are interchangeable.
Omni-directional LED
2-5
Product Overview
2.6.2
GUI Rear View
Figure 2-2. GUI Rear View
Reference Common Symbols found on GUI or BDU Labels , p. 2-11 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 Operator’s Manual
2.6.3
BDU Front View
Figure 2-3. BDU Front View
Product Views
Operator’s Manual
3
4
1
2
Condensate vial
Exhalation filter
Exhalation filter latch
AC power indicator
7
8
5
6
Power switch
Status display
Internal inspiratory filter
Option connector panel door
2-7
Product Overview
Symbol
Table 2-2. BDU Front Label Symbols and Descriptions
Description
To Patient port
From Patient port
Exhalation filter latch locked (down)/unlocked (up)
2.6.4
BDU Rear View
Figure 2-4. BDU Rear View
2-8 Operator’s Manual
Product Views
1
2
3
4
Standard base
Air inlet
Oxygen inlet
Labels indicating installed software options
5
6
7
Service mode button
Remote alarm port
Cylinder mount (optional)
Software option labels are applied to the grid located on the back of the ventilator, as shown below and in the previous image (item 4).
Figure 2-5. Installed Software Options
The following table lists the symbols and descriptions found on BDU or base labels.
Symbol
Table 2-3. BDU Rear Label or Panel Symbols and Descriptions
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 connections.
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).
Operator’s Manual 2-9
Product Overview
Table 2-3. BDU Rear Label or Panel Symbols and Descriptions (Continued)
Symbol Description
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.
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).
2-10 Operator’s Manual
Operator’s Manual
Table 2-3. BDU Rear Label or Panel Symbols and Descriptions (Continued)
Symbol Description
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).
Symbol
Table 2-4. Common Symbols found on GUI or BDU Labels
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. Reference Manufacture Date , p. 1-16 for details regarding inter-
pretation of the serial number.
WEEE – Proper waste disposal. Follow local governing ordinances regarding disposing of waste labeled with the WEEE symbol.
Product Views
2-11
Product Overview
2.6.5
Ventilator Side Views
Figure 2-6. Ventilator Right Side View
2-12 Operator’s Manual
Figure 2-7. Ventilator Left Side View
Mounting Configurations
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, and the GUI displays a rep-
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. Reference Using Battery
2.9
Graphical User Interface
There are two displays on the ventilator — the primary display (GUI) and the status display.
Operator’s Manual 2-13
Product Overview
2.9.1
Primary Display
•
•
•
The GUI incorporates a 15” 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 below.
Key symbol
Table 2-5. GUI Control Keys
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 ventilator (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 GUI Touch
.
Alarm volume key — Adjusts the alarm volume. The alarm volume cannot be turned OFF.
2-14 Operator’s Manual
Operator’s Manual
Key symbol
GUI Controls and Indicators
Table 2-5. GUI Control Keys (Continued)
Description
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
L
) to high pressure P
H
) (or vice versa). To avoid breath stacking, a manual inspiration is not delivered during inspiration or during the
restricted phase of exhalation. Reference Manual Inspiration , p. 10-18 for information 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 purposes of measuring end inspiratory pressure (P
I END
) for calculation of plateau pressure
(P
PL
), static compliance (C
STAT
), and static resistance (R
STAT
).
Expiratory pause key — Initiates an expiratory pause which extends the expiratory phase of the current breath in order to measure total PEEP (PEEP
L
).
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.
2-15
Product Overview
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 2-9.
2.10.3
Visual Indicators
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.
Symbol
Table 2-6. GUI Visual Indicators
Description
Ventilator Setup (Vent Setup) button. Located at the lower left corner of the GUI. Touch this button to open the ventilator setup screen.
Adult patient circuit indicator. Indicates adult circuit type tested during SST, and in use. Appears above the Vent Setup button.
2-16 Operator’s Manual
Operator’s Manual
GUI Controls and Indicators
Symbol
Table 2-6. GUI Visual Indicators (Continued)
Description
Pediatric patient circuit indicator. Indicates pediatric circuit type tested during SST, and in use. Appears above the Vent Setup button.
Manual Event
Neonatal patient circuit indicator. Indicates neonatal circuit type tested during SST, and in use. Appears above the Vent Setup button.
dialogs on the GUI screen. The display resumes showing the ventilator 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. Reference the
Trending addendum for more information about events
settings screen, which allows alarm limits to be changed.
screen, which contains tabs for Alarms, Settings,
Patient Data, Diagnostics, EST/SST status, General
Event, and Service logs.
Elevate O
2
control. A constant access icon. Reference
Areas of the GUI , p. 4-3. Touch this icon to increase the
set the elevated oxygen concentration to the institutional default O
2
configuration (if institutional default has been configured) for two minutes, or allows the operator to determine the additional percentage of oxygen to increase. The O
2
concentration for the two-minute increase can be set to any value between 1% and 100% O
2
. If the Elevate O
2
function is active, touching Extend re-starts the two-minute interval. The Elevate O
2
function can be terminated prior to completion of the two-minute interval by touching Stop . Any time the Elevate O
2
control is activated, an entry is made to the patient data log.
procedure for capturing screen images.
2-17
Product Overview
2-18
Symbol
Table 2-6. GUI Visual Indicators (Continued)
Description
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. Reference
Areas of the GUI , p. 4-3. 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 in order 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. Reference Pushpin
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. Reference Pushpin Icon , p. 4-4
Low priority alarm icon (appears on alarm banner).
Medium priority alarm icon (appears on alarm banner).
High priority alarm icon (appears on alarm banner).
Operator’s Manual
GUI Controls and Indicators
2.10.4
On-screen Symbols and Abbreviations
Touch an on-screen symbol briefly (0.5 s ) 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 five (5) seconds if left alone. Expanding the tooltip dialog prevents the tooltip from timing out. Touching outside the tooltip causes the dialog to close.
The table below summarizes the ventilator’s symbols and abbreviations.
Operator’s Manual 2-19
Product Overview
2-20
Symbol or Abbreviation
T
A
D
SENS
C
DYN
R
DYN
EEF
P
I END
LEAK
P
CIRC
LEAK
Y
V
TE MAND
V
V
V
E TOT
E SPONT
TE SPONT
E
V
SENS
T
TE
E
Table 2-7. Symbols and Abbreviations
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)
V
CIRC
V
CIRC Y
V
SENS
V
TRIG
V
Y
P
H
P
Y
T
H
Flow pattern (square)
Monitored total inspiratory and expiratory flow
Monitored inspiratory and expiratory flow measured at the proximal airway
Flow sensitivity
Flow triggering
Inspiratory and expiratory patient flow
High pressure setting (in BiLevel)
Monitored circuit pressure throughout the breath cycle measured at the proximal airway
High pressure time (in BiLevel)
Operator’s Manual
Operator’s Manual
GUI Controls and Indicators
Table 2-7. Symbols and Abbreviations (Continued)
Symbol or Abbreviation
T
H
:T
L
I:E
V
TL
PEEP
I
PEEP
I PAV
P
L
T
L
P
MEAN
NIF
O
2
%
P
0.1
C
PAV
E
PAV
% Supp
R
PAV
R
TOT
WOB
TOT
C
20
/C
V
LEAK
T
I
P
I
V
TI
P
PEAK
PEF
V
MAX
PSF
PEEP
%Leak
P
PL
Definition
High pressure time to Low pressure time ratio (in BiLevel)
Inspiratory time to expiratory time (I:E)
Inspiration compliance ratio
Inspiratory leak
Inspiratory time
Inspiratory pressure
Inspired tidal volume
Inspired tidal volume (when Leak Sync is enabled)
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
2-21
Product Overview f/V
T
T
SPONT
T
I
/T
TOT
C
STAT
R
STAT
V
T
V
T CIRC
V
T Y
PEEP
L f
TOT
VC
VS
Table 2-7. Symbols and Abbreviations (Continued)
Symbol or Abbreviation
T
PL
P
COMP
P
SENS
P
SUPP
P
TRIG
V
TIY
V
TEY
V
TI MANDY
V
TI SPONTY
V
TLY f
Definition
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
Spontaneous rapid/shallow breathing index
Spontaneous inspiratory time
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
2-22 Operator’s Manual
Breath Delivery Unit
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 silence 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 .
Function
Low priority alarm tone
Table 2-8. GUI Audible Indicator Functions
Description
A series of two tones. Sounds when a low priority alarm occurs.
Medium priority alarm tone
High priority alarm tone
A repeating series of three tones. Sounds when a medium priority alarm occurs.
A repeating series of five tones. Sounds when a high priority alarm occurs.
Soft bound tone
Hard bound tone (invalid entry)
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.
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.
2-5. The keys activate other ventilator functions. Reference GUI Control Keys , p. 2-14.
2.11
Breath Delivery Unit
The breath delivery unit contains the hardware and software to enable the ventilator to provide patient support.
Operator’s Manual 2-23
Product Overview
2.11.1
BDU Controls and Indicators
BDU Controls
• ON/OFF switch — Lift the switch cover and turn the ventilator ON or OFF.
Figure 2-8. Ventilator Power Switch and AC Indicator
2-24
•
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.
Operator’s Manual
Figure 2-9. Service Mode Button (TEST)
Breath Delivery Unit
1 Service mode button
Note:
The Covidien splash screen shows the Covidien logo and appears momentarily as a banner on the status display.
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
for a summary of the information appearing on the status display.
Status Display
•
The status display is a separate display located on the BDU. Reference BDU Front View , p. 2-7, item
6. 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
Operator’s Manual 2-25
Product Overview
•
•
•
•
•
Presence of primary and extended batteries and their charging status
Relative available battery charge level
Circuit pressure graph displaying pressure units, 2 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.
The figure below shows a sample of the status display during normal ventilation (compressor option not installed).
Figure 2-10. Sample Status Display During Normal Ventilation
2-26
1
2
3
4
5
Primary and extended battery status (presence or absence).
Alarm volume setting
6
7
Gas connection status
Power status
Measured peak circuit pressure (updated at the end of the current breath)
8
9
P
PEAK
alarm setting
Measured inspiratory pressure (changes as pressure changes)
Selected pressure units
Measured PEEP
Operator’s Manual
Breath Delivery Unit
•
•
•
•
•
•
During Service mode the status display supplies
Ventilator serial number(s)
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
for status display possibilities.
Typical Status Display Indicators and Messages
The following table lists indicators and messages that appear on the status display.
Table 2-9. 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 ventilator to enter Service mode.
POST failure. This image appears if a POST error occurs at ventilator start-up, along with the error code (in this case a missing primary battery).
Operator’s Manual 2-27
Product Overview
Table 2-9. Status Display Indicators and Descriptions (Continued)
Status Display Indicator or Message Meaning
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.
Failure of the EVQ during power on self test. Reinstall or replace the EVQ and run flow sensor calibration from Service mode.
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
and PEEP values.
Stand-by state. The status display appears as shown when the ventilator is in stand-by state.
2-28 Operator’s Manual
Operator’s Manual
Breath Delivery Unit
Table 2-9. Status Display Indicators and Descriptions (Continued)
Status Display Indicator or Message Meaning
Battery charged. The ventilator’s primary battery (in the right-most slot) is shown fully charged, represented by a + symbol and green color. (Image shown without optional compressor installed).
Battery charging. Identifies that the ventilator’s primary battery is charging. This icon is animated; orange bars scroll upward towards a “+” sign indicating the battery is charging. Green bars show the relative remaining battery capacity. If an extended battery is installed, the image shows a similar representation in the extended battery location (left-most receptacle). (Image shown without optional compressor installed).
Battery icon. Denotes the ventilator is operating on battery power when this image appears on any status display indicator. Alerts the operator there is insufficient AC power to operate the ventilator. The indicator is replaced by the “on AC power” indicator when adequate AC power is restored.
On battery power. Alerts the operator there is insufficient AC power to operate the ventilator. Ventilator is operating on battery power with greater than ten minutes of capacity remaining. Note the appearance of the battery icon. (Image shown without optional compressor installed).
2-29
Product Overview
Table 2-9. Status Display Indicators and Descriptions (Continued)
Status Display Indicator or Message Meaning
Low battery. Identifies that the ventilator’s primary battery (right-most slot) is discharging and there are ten 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 slot). (Image shown without optional compressor installed).
Critically low battery. Identifies that the ventilator’s primary battery has less than five 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 representation in the extended battery location.
(Image shown without optional compressor installed).
Power failure. Alerts the user that the ventilator’s battery is depleted or depletion is imminent.
Replace primary or extended battery with a fully charged battery or connect ventilator to AC power.
Battery Inoperative. This image appears on the status display when a battery fault renders the battery inoperative. (Image shown without optional compressor installed).
2-30 Operator’s Manual
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Breath Delivery Unit
Table 2-9. Status Display Indicators and Descriptions (Continued)
Status Display Indicator or Message Meaning
Battery not installed. This image appears when there is no primary battery installed, and renders the ventilator inoperative. (Image shown without optional compressor installed).
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 visual alarms are NOT annunciated, and the status display shows a count-down timer until the completion of the GUI transient reset. The countdown lasts for approximately 30 s.
GUI Failure. Indicates a loss of communication between the BDU and the GUI that cannot be recovered by the ventilator system. During the GUI failure, ventilation continues as currently set, audible and visual 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.
• Assess patient status by reviewing other monitoring indicators (for example, oxygen saturation, heart rate, blood pressure, etc.).
• Transfer the patient to an alternate source of ventilation consistent with your institution’s protocol.
2-31
Product Overview
Table 2-9. Status Display Indicators and Descriptions (Continued)
Status Display Indicator or Message Meaning
Ventilator inoperative (Vent Inop). Indicates the ventilator 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 ventilation 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. Reference Safety Valve Open (SVO) , p. 4-31.
Backup Ventilation (BUV) indicator. Indicates the ventilator has entered the backup ventilation state.
See
Background Diagnostic System (10.16.4)
on page
for a description of BUV.
AC power indicator. When this image appears on any status display indicator, indicates the ventilator is operating on AC power.
Status display appearance when ventilator is breathing in Normal mode. Note the appearance of the AC power icon.
2-32 Operator’s Manual
Breath Delivery Unit
Table 2-9. Status Display Indicators and Descriptions (Continued)
Status Display Indicator or Message Meaning
Air available indicator. When this image appears on any status display indicator, indicates the ventilator is connected to a pressurized air source.
O
2
available indicator. Indicates ventilator is connected to a pressurized O
2
source.
BDU Audible Indicators
The continuous tone alarm is the only audible indicator in the BDU, and is described in Table 2-10.
Indicator
Continuous tone alarm
(Immediate priority)
Table 2-10. BDU Audible Indicator Functions
Description
A continuous tone annunciated when there is a Ventilator Inoperative (Vent
Inop) condition. This alarm lasts for a minimum of two (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 22mm (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. Reference Appendix
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. Reference Port Use
, p. 5-17 for more information. Reference To configure
nal devices.
Operator’s Manual 2-33
Product Overview
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. Reference 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/compressor operation. Reference Environmental Specifications , p. 11-8.
2.13
Special Features
A Proximal Flow option is available. The proximal Flow Sensor is used to measure low flows and
2.14
Color Definitions
Reference the following figures to view the ventilator’s pneumatic diagram during inspiration with various colors representing the gases as shown below.
Color or
Symbol
Table 2-11. Color Legend
Description
High-pressure Oxygen (NFPA 99 designation)
High-pressure Air (NFPA 99 designation)
Mixed gases, including air
Atmosphere
Vacuum
Water
2-34 Operator’s Manual
Pneumatic Diagrams
2.15
Pneumatic Diagrams
The following figures illustrate the ventilator’s pneumatics with and without the optional Proximal
Flow System. The Proximal Flow System is only for use with neonatal patients.
Note:
Both the compressor and the Proximal Flow System are hardware options.
Figure 2-11. Pneumatic Diagram (Compressor Shown)
Operator’s Manual 2-35
Product Overview
2-36
4
5
1
2
3
13
22
23
47
48
49
14
15
16
Pressure switch, mix accumulator (PS1)
Solenoid Valve, options supply (SOL2)
Pressure sensor, mix accumulator (P
MX
)
Accumulator, mix (ACC
M
)
Tube, mix (T
M
)
7
8
9
10
6
11
12
Proportional solenoid valve, patient gas delivery (PSOL
D
)
Solenoid valve, BUV (SOL 3)
Safety valve (SV)
Pressure sensor, safety valve (P
SV
)
Solenoid valve, inspiratory pressure sensor autozero (SOL4)
Pressure sensor, inspiratory (P
I
)
Pressure sensor, barometric (PA)
Vial, exhalation condensate
Filter, exhalation (F4)
Flow sensor assembly, exhalation valve
Exhalation valve (EV)
17
18
19
20
21
Filter, exhalation pressure line (F5)
Solenoid Valve, exhalation pressure autozero (SOL 5)
Pressure sensor, exhalation (PE)
Humidifier
Filter, External bacteria (F
D2
)
Filter, Internal bacteria (F
D1
)
Check valve, patient gas delivery (CV
D
)
Check valve, wall Air inlet (CV
WAir
)
Filter, Oxygen Impact (F1)
Filter element, Oxygen (F3)
30
31
32
33
24
25
26
27
28
29
Sensor, Oxygen (OS)
Restrictor, breath delivery bypass (R2)
Flow sensor, patient gas delivery (FS
D
)
Accumulator, compressor (ACC
C
)
Relief valve, compressor accumulator
(RV
CA
)
Solenoid valve, compressor unload (SOL7)
Motor Compressor (MC)
Heat exchanger, compressor (HE)
Filter, compressor air (F7)
Dryer, compressor
34
35
36
37
38
39
40
41
42
43
44
45
46
51
52
53
Filter, muffler (F6)
Check valve, compressor accumulator
(CV
CA
)
Pressure sensor, compressor accumulator
(PC)
Check valve, Oxygen (CVO
2
)
Check valve, Air (CV
Air
)
Proportional solenoid valve, Oxygen
(PSOLO
2
)
Flow sensor, Air (FS
Air
)
Proportional solenoid valve, Air
(PSOL
Air
)
Pressure sensor, air gas inlet (P
Air
)
Restrictor, wall air bleed outlet (R1)
Check valve, compressor air inlet
(CV
CAir
)
Filter bowl assembly, Air (WT2)
Filter element, Air (F2)
Flow sensor, Oxygen (FSO
2
)
Restrictor, Prox Flow (R4)
Relief Valve, mix accumulator (RVMA)
Operator’s Manual
Pneumatic Diagrams
50 Pressure sensor, Oxygen gas inlet (PO
2
) 54 Solenoide Valve, mix accumulator purge
(SOL 1)
Figure 2-12. Pneumatic Diagram — Compressor and Prox Flow Systems
1
2
3
4
Restrictor, Prox Flow (R4)
Solenoid Valve, Prox Flow (SOL 6)
Module, Proximal Flow System
Pressure Sensor, Prox Flow Accumulator
(P
PROX
)
Humidifier
6
7
8
9
Wye, patient circuit
Sensor, Proximal Flow
Filter, neonatal exhalation
Condensate vial, neonatal expiratory
5
Items enclosed by dotted line represent components internal to the ventilator.
Operator’s Manual 2-37
Product Overview
Page Left Intentionally Blank
2-38 Operator’s Manual
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 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:
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.
3-1
3-2
Installation
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
factory-trained Biomedical Engineers per the schedule specified. Reference Service Preventive
Maintenance Frequency , p. 7-19.
3.3
Product Assembly
3.3.1
How to Assemble Ventilator Components
Ventilator setup should have already been completed by factory-trained service personnel including successfully passing EST. This manual does not include ventilator assembly instructions.
3.3.2
Product Power Sources
Using AC Power
The ventilator is normally AC-powered. Reference Connecting the Ventilator to AC Power , p. 3-4 to
connect the ventilator to AC power.
Using Battery Power
WARNING:
Use only Covidien-branded 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. Reference Battery Compartment Locations , p. 3-19 for identification of battery
slots.
Operator’s Manual
Product Assembly
The ventilator’s primary battery must be installed by qualified service personnel (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 one 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 back-up 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 slot is available for the ventilator and the compressor. If both primary and extended ventilator and compressor batteries are present, these batteries can power the ventilator and compressor for two hours (one hour for the primary battery and one 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.
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 six 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
Operator’s Manual 3-3
Installation is now operating on battery power and AC POWER LOSS alarm annunciates. A medium priority alarm annunciates when the remaining run-time for the ventilator drops to ten (10) minutes and a high priority alarm annunciates when the remaining time drops to five (5) minutes.
3.4
Product Placement
The ventilator is positioned standing on its casters next to the patient’s bedside, as shown below.
Move the ventilator using the handle encircling the BDU and roll the ventilator to the desired location.
Figure 3-1. Example of Freestanding Ventilator Placement
3-4
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.
Operator’s Manual
Product Connectivity
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.
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. Reference Power Cord Retainer on BDU , p. 3-6.
2.
Replace the power cord 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.
Operator’s Manual 3-5
Installation
Figure 3-2. Power Cord Retainer on BDU
3-6
3.5.2
Connecting the Gas Supplies
2
supply pressure ranges must be between 35 and 87 psig (241.3 kPa and 599.8 kPa) 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 ≥ three (3) s .
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 < 50 psi (345 kPa) are employed.
Operator’s Manual
Product Connectivity
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.
WARNING:
Use of only one gas source could lead to loss of ventilation and/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
To connect the gas sources
1.
Connect the oxygen hose to the oxygen inlet fitting (item 1) as shown. Ensure use of a medical grade oxygen source.
2.
Figure 3-3. Connecting the Ventilator to the Gas Supplies
Operator’s Manual
1 O
2
gas connection 2 Air gas connection
3-7
3-8
Installation
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
:
BOC, DISS, DISS female, NIST, Air Liquide, SIS, and Dräger
Reference Accessories and Options , p. 9-3 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. Reference Accessories and
Options , p. 9-3. To prevent infection and contamination, both inspiratory and exhalation filters
must be used with the ventilator.
WARNING:
In order 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. Reference Accessories and Options , p. 9-3 for relevant
part numbers.
WARNING:
Refer to the filter’s instructions for use 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 instructions for use (IFU) for information on reusable filter cleaning and sterilization and filter efficiency.
WARNING:
Do not re-use 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.
Operator’s Manual
Product Connectivity
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 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.
Reference Appendix D 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
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.
Operator’s Manual 3-9
Installation
Figure 3-4. Adult/Pediatric Filter Installation
3-10
1
2
3
4
Condensate drain port
Condensate vial
Exhalation filter
Condensate vial gasket
5
6
7
Condensate drain port cap
Exhalation filter latch
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. Reference Installing the Neonatal Filter, p. 3-15 (item 3).
3.
Remove existing exhalation filter door by lifting it off of the pivot pins.
4.
Fit neonatal adapter door onto pivot pins.
Operator’s Manual
Figure 3-5. Installing the Neonatal Filter
Product Connectivity
1
2
Neonatal exhalation filter
Neonatal adapter door
3
4
Exhalation filter latch
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.
Re-attach expiratory limb of patient circuit to 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.
, p. 3-12. Reference Accessories and Options , p. 9-3 for part number of drain bag holder.
Operator’s Manual 3-11
Installation
Figure 3-6. Drain Bag
3-12
3.5.4
Connecting the Patient Circuit
Reference Connecting the Adult or Pediatric Patient Circuit , p. 3-14 or Reference
WARNING:
Use patient circuits of the lowest compliance possible with the ventilator system to ensure optimal compliance compensation and to avoid reaching the safety limit of five times set tidal volume or the compliance compensation limit. Reference the table below for circuit types corresponding with predicted body weight (PBW).
Operator’s Manual
Product Connectivity
Table 3-1. Patient Types and PBW Values
Circuit Type
Neonatal
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)
Allowed but not recommended
Not applicable
Pediatric
Adult 25kg to 150 kg (55 lb to 331 lb)
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 instructions for use (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. Reference Accessories and
Options , p. 9-3. 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 instructions for use (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.
Operator’s Manual 3-13
Installation
Figure 3-7. Connecting the Adult or Pediatric Patient Circuit
3-14
3
4
1
2
5
Humidifier
Inspiratory limb
Circuit wye
Expiratory limb
Condensate vial
8
9
6
7
From Patient port
Exhalation filter
To Patient port
Inspiratory filter
Operator’s Manual
Figure 3-8. Connecting the Neonatal Patient Circuit
Product Connectivity
1
2
Humidifier
Patient circuit inspiratory limb
6
7
3
4
5
Circuit wye
Patient circuit expiratory limb
Condensate vial
8
9
WARNING:
Do not attempt to sterilize single-patient use circuits.
From patient port
Neonatal exhalation filter (installed in adapter door)
To patient port
Inspiratory filter
Operator’s Manual 3-15
Installation
3.6
How to Install Accessories
3.6.1
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.
Cleaning Agents , p. 7-5. 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/or 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. Reference Proper Battery Orientation , p. 3-18.
3-16 Operator’s Manual
Figure 3-9. Ventilator Battery
How to Install Accessories
1 Battery connector
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. Reference Battery Compartment Locations , p. 3-19. 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
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
Operator’s Manual 3-17
Installation 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 3-10. Proper Battery Orientation
3-18
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.
Operator’s Manual
Figure 3-11. Battery Compartment Locations
How to Install Accessories
1
2
5
BDU extended battery receptacle and ejector
BDU primary battery receptacle and ejector
Compressor extended battery receptacle and ejector
3
4
6
BDU and compressor primary battery thumbscrews
Compressor primary battery receptacle and ejector
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.
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. Reference Proper Battery Orientation , p. 3-18.
Operator’s Manual 3-19
Installation
2.
Push the battery into the forward receptacle of the appropriate module of the ventilator all the way
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.
Note:
Reference Battery Charging , p. 3-3 for battery charging information when batteries are installed in
ventilator.
3.6.2
Battery Testing
To test the batteries
1.
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
battery test button and LEDs.
3.6.3
Battery Life
Battery life is approximately three (3) years. Actual battery life depends on the history of use and ambient conditions.
3.6.4
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.
3.6.5
Flex Arm
Use the flex arm to support the patient circuit between the patient and the ventilator. Reference
, which illustrates flex arm installation into the sockets provided.
3-20 Operator’s Manual
Figure 3-12. Flex Arm Installation
How to Install Accessories
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 un-fastening the flex arm from the threaded fastener in the handle.
3.6.6
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. Reference Bracket Instal-
Operator’s Manual 3-21
Installation
lation on Rail , p. 3-23. Reference
Accessories and Options , p. 9-3 for the part number of the humid-
ifier bracket.
WARNING:
Selection of the incorrect humidifier type and/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 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 Instructions for Use (IFU) when using a humidifier with patient ventilation.
Caution:
Follow humidifier manufacturer’s instructions for use (IFU) for proper humidifier operation.
To install the humidifier bracket
1.
Attach 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 (4)
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.
3-22 Operator’s Manual
Figure 3-13. Bracket Installation on Rail
How to Install Accessories
To install the humidifier
1.
Slide the rear of the humidifier into the corresponding slot on the humidifier bracket, until it is fully seated.
humidifier bracket, and some humidifiers use the wide slot.
Operator’s Manual 3-23
Installation
Figure 3-14. Humidifier Installation to Ventilator
3-24
2.
Fill the humidifier 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.
Operator’s Manual
Ventilator Operating Modes
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.
3.7
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. If the clinician chooses, s/he 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
alarm, the LED displays the color corresponding to the highest priority level. If the alarm de-escalates, 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 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 (10) L/min to limit gas consumption and to allow for detection of patient reconnection and
O
2
concentration becomes 100% for adult and pediatric circuit types and 40% for neonatal circuit types. Stand-by state is available in all ventilation modes except during Inspiratory and Expiratory
Operator’s Manual 3-25
Installation
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
1.
Reconnect the patient circuit. The ventilator resumes ventilation at the settings in use before the disconnection.
•
•
•
The following ventilator settings become active during Stand-by state:
Base flow is set to ten (10) L/min
100% O
2
for adult/pediatric patients
40% O
2
for neonatal patients
3-26 Operator’s Manual
Ventilator Operating Modes
•
•
•
•
•
•
•
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 below.
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 silenced 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 Covidien factory-trained service personnel), 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 Log
Operator’s Manual 3-27
Installation
•
•
•
•
•
•
•
System Comm. Log
EST/SST Diagnostic log
Settings Log
Alarms Log
General Event Log
Service log
Patient data Log
Reference 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. Reference Service Mode
, p. 3-29. Reference Status Display Indicators and Descriptions , p. 2-27 for an image of the
splash screen. The ventilator prompts to confirm no patient is attached.
3-28 Operator’s Manual
Figure 3-15. Service Mode Button (TEST)
Ventilator Operating Modes
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 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.
Reference 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. Reference the following table for a list of institutionally- and operator-configurable items.
Operator’s Manual 3-29
Installation
3.8
Product Configuration
WARNING:
If the ventilator fleet in your institution uses multiple institutionally configured presets and/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. The following table lists the factory-configured settings, the institutionally-configurable settings, and the operator-configurable settings.
Feature
Vital patient data banner
Large font patient data panel
Waveform layout
Display brightness (Light settings)
Alarm volume
Elevate O
2 control
Date/time format
Default mL/kg ratio
Factory Configured
X
Table 3-2. Ventilator Configuration
Institutionally Configurable
X
Operator
Configurable
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Configured by Circuit
Type
User Lockable
X
X
X
X
X
X
Can’t be changed in
Normal mode
3-30 Operator’s Manual
Product Configuration
Feature
New patient startup defaults
(including
PBW, vent type, mode, mandatory type, trigger type, O
2
%, elevate O
2
)
Opacity
X
Table 3-2. Ventilator Configuration (Continued)
Factory Configured
Institutionally Configurable
X
Operator
Configurable
Configured by Circuit
Type
X
User Lockable
X X 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
Mode , p. 3-27 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.
Reference the sections below 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
. Reference Service Mode , p. 3-27, 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 .
Operator’s Manual 3-31
Installation
3.8.2
Configuring the GUI
The display can be configured in various ways.Reference Ventilator Configuration , p. 3-30 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.
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 one-hour and one-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 or
MM-DD-YYYY where MM is a two digit month format, DD is a two-digit day format, and YYYY is a fourdigit 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.
Enter Service Mode, and confirm no patient is attached by touching Configuration . Reference Service
Mode, p. 3-32 for instructions on entering Service Mode.
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.
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Product Configuration
Pressure Units
The ventilator’s pressure units can be configured for hPa or cmH
2
O.
To institutionally configure pressure units
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration
Mode , p. 3-27 for instructions on entering Service Mode.
2.
Touch Vent Setup .
3.
Touch the button corresponding to the desired pressure units.
4.
If done configuring parameters, exit Service Mode by touching Exit .
Screen Brightness and Keyboard Backlight (Light Settings)
To institutionally configure screen brightness and keyboard backlight
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration
Mode , p. 3-27 for instructions on entering Service Mode.
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 five (5) s .
New Patient Setup Defaults
To institutionally configure new patient default settings
1.
Touch the button corresponding to adult, pediatric, or neonatal New Patient Defaults.
2.
Touch the Vent type , Mode , Mandatory type , and Trigger type buttons corresponding to the desired parameters.
3.
Configure the default PBW and mL/kg ratio, Elevate O
2
and O
2
% by touching its button and turning the knob.
4.
Repeat for each patient type by selecting the corresponding button.
5.
Touch Accept or Accept ALL when the default configuration is complete.
Operator’s Manual 3-33
Installation
6.
If done configuring parameters, exit Service Mode.
Elevate O
2
Note:
The Elevate O
2
control adds a percentage of O
2
to the breathing mixture for two minutes. The additional percentage is shown on the icon in the constant access icon area. The allowable range is 1% to 100%.
To adjust the amount of elevated O
2
delivered for two minutes
1.
In the vent setup dialog in Normal mode, touch the Elevate O
2
icon in the constant access icons area of the GUI screen. The icon glows and a dialog appears with a countdown timer, Elev O
2
button highlighted and ready for changes, and Extend , Stop , and Close buttons.
2.
Turn the knob to increase or decrease the amount of oxygen by the amount shown on the button. The allowable range is +1% to +100% oxygen.
3.
Touch Extend to extend the two-minute interval. Touching Extend restarts the two-minute countdown timer.
4.
Touch Stop to stop additional oxygen from being delivered and dismiss the countdown timer.
•
•
•
The Elevate O
2
function follows these rules:
If apnea ventilation occurs during the two-minute interval, the apnea % O
2
delivery also increases by the configured amount.
During LOSS OF AIR SUPPLY or LOSS OF O
2
SUPPLY alarm conditions, the Elevate O
2
function is canceled if in progress, and is temporarily disabled until the alarm condition no longer exists.
During Safety PCV, the Elevate O
2
control has no effect. During circuit disconnect and stand-by states
(when the ventilator is turned on but not ventilating) the Elevate O
2
function affects the currently delivered oxygen concentration, not the set oxygen concentration.
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.
Enter Service Mode, and confirm no patient is attached by touching Configuration
Mode , p. 3-27 for instructions on entering Service Mode.
2.
Touch Alarm Volume Defaults . A screen appears allowing configuration of the alarm volume by circuit type.
3-34 Operator’s Manual
Product Configuration
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 five (5) seconds.
Note:
A sample alarm tone sounds for verification at each volume level change. If necessary, re-adjust 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.
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.
Reference Areas of the GUI , p. 4-3. A total of 14 values may
be configured at one time, with eight (8) values visible, and six (6) 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.
Reference Ventilator Settings Range and Resolution , p. 11-9 for default patient data values.
To institutionally configure patient data displayed on the GUI
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration
Mode , p. 3-27 for instructions on entering Service Mode.
2.
Touch Patient Data Defaults . Five (5) 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.
Operator’s Manual 3-35
Installation
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.
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.
Enter Service Mode, and confirm no patient is attached by touching Configuration
Mode , p. 3-27 for instructions on entering Service Mode.
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.
3-36 Operator’s Manual
Product Configuration
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 above.
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. Reference Areas of the GUI , p. 4-3. 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.
Enter Service Mode, and confirm no patient is attached by touching Configuration
Mode , p. 3-27 for instructions on entering Service Mode.
2.
Touch Graph Defaults . Five (5) layout presets appear along with a list of parameters and descriptions.
3.
Touch a layout preset button. The parameter(s) 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 above.
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 Waveform Layout , 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(s) icon to display. The selected waveform(s) 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.
Operator’s Manual 3-37
Installation
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.
Reference To capture GUI screens , p. 5-2 for information on storing waveforms.
Opacity
To institutionally configure screen opacity
1.
Enter Service Mode, and confirm no patient is attached by touching Configuration. Reference Service
Mode , p. 3-27 for instructions on entering Service Mode.
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 control 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
p. 3-17 for the meaning of battery charge
for the location of battery test switch and status LEDs.
Prior to connecting a patient to the ventilator for the first time, a qualified service technician must have calibrated the ventilator’s exhalation valve, flow sensors, and atmospheric pressure transducer and performed and successfully passed EST. Reference the Puritan Bennett™ 980 Ventilator
Service Manual for instructions.
In addition, the clinician must also perform SST.
3-38 Operator’s Manual
Installation Testing
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 and/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 ventilator breathing system (VBS) compliance may trigger a COMPLIANCE LIMITED V
T
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 support (PS).
•
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 five-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 or removing accessories to 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 rerunning SST. For optimal breath delivery, run SST after changing humidification type and humidifier volume.
Operator’s Manual 3-39
Installation
SST results are recorded in the SST results log, viewable in Service Mode and in Normal Mode using the configuration (wrench) icon.
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)
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 t ouch 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
3-40 Operator’s Manual
Installation Testing turn the knob to enter the volume. See
Table 3-4. for adult and pediatric patients or Table 3-5.
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
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.
The following table lists the tests performed during SST.
Test step
SST Flow Sensor Cross Check Test
SST Exhalation Valve Performance
SST Circuit Pressure Test
SST Leak Test
SST Exhalation Filter Test
SST circuit Resistance Test
SST circuit Compliance Test
SST Prox (if Proximal Flow Option is installed)
Table 3-3. SST test Sequence
Function
Tests O
2
and Air Flow Sensors
Calibrates the exhalation valve and creates a table for use during calculations
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 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 Proximal Flow Subsystem
Operator’s Manual 3-41
Installation
Manufacturer
Fisher & Paykel
Fisher & Paykel
Fisher & Paykel
Fisher & Paykel
Fisher & Paykel
Teleflex (Concha)
AirLife
Table 3-4. Humidifier Volumes for Adult and Pediatric Patients
Model Description
MR225
SST humidifier volume Setting (mL)
300
MR290
MR250
MR210
MR370
382-10
AH290
Ped, disposable, manual feed
Ped/adult disposable, autofeed
Adult, disposable, manual feed
Adult, disposable, manual feed
Adult, reusable, manual feed
ConchaSmart
Disposable, autofeed
380
480
480
725
300
380
Table 3-5. Humidifier Volumes for Neonatal Patients
Manufacturer Model Description
Fisher & Paykel MR290
SST humidifier volume setting (mL)
550
1
Teleflex (Concha)
AirLife
382-10
AH290
Neo/adult disposable, autofeed
ConchaSmart
Disposable, autofeed
390
520
1.
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 neonatal patient types, enter the SST humidifier volume listed in
during SST or when specifying the humidifier volume.
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.
3-42 Operator’s Manual
Installation Testing
Test status
PASS
ALERT
FAIL
Table 3-6. Individual SST Results
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.
Response
No need to do anything, unless prompted by the ventilator.
•
When the system prompts, touch one of these buttons:
Repeat Test
•
Next Test
The ventilator has detected a critical problem and SST cannot complete until the ventilator passes the failed test.
•
Exit SST
Eliminate leaks in the ventilator breathing system and re-run SST. Otherwise, service the ventilator and re-run SST.
SST Outcomes
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.
When SST completes all of the tests, analyze the results.
Final Outcome
PASS
ALERT
FAIL
Table 3-7. Overall SST Outcomes
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.
Response
Touch Patient Setup to set up the patient for ventilation
To override the alert, touch then touch Accept
To exit SST, touch
.
Exit SST .
Override SST ,
One or more critical faults were detected.
The ventilator enters the SVO state and cannot be used for normal ventilation until SST passes.
Check the patient circuit to determine the problem or restart SST with a different patient circuit.
Touch Repeat Test , Run All SST , or Exit SST , then touch Accept .
If touching Override SST, observe the following warning:
A single circuit leak test can be run, but the full suite of SST test must successfully pass before releasing the ventilator for clinical use.
Operator’s Manual 3-43
Installation
•
•
•
If a complete SST is interrupted and ventilation was allowed before starting SST, normal ventilation is allowed if
SST did not detect any failures or alerts before the interruption, and no other errors that would prevent ventilation occurred, and 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
EST (Extended Self Test)
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.
EST Self Test 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 35 and 87 psi
(241 to 599 kPa).
To perform Extended Self Test (EST) or to access additional service functions, the ventilator must
be in Service Mode. Reference Service Mode , p. 3-27.
3-44 Operator’s Manual
Installation Testing
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 six 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.
Equipment for EST
1.
Covidien gold standard test circuit
2.
Number one stopper
Operator’s Manual 3-45
Installation
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/oxygen hose assemblies, certain EST tests may fail when using supply pressures less than50 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. Reference EST Self Test Prerequisites , p. 3-44.
2.
Collect the appropriate equipment. Reference Equipment for EST , p. 3-45.
3.
Access Service Mode. Reference Service Mode , p. 3-27.
4.
Verify all three 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 indefinite-
ly for a response. Reference EST Test Sequence , p. 3-46.
12.
At the DISCONNECT O
2
prompt, disconnect the high pressure oxygen source.
13.
At the CONNECT AIR AND O
2
prompt, connect both high pressure air and oxygen sources.
14.
Touch Run All or select the desired individual test. After each test, the ventilator displays the results.
3-46 Operator’s Manual
Installation Testing
15.
If a particular test fails, either repeat the test or perform the next test.
16.
When all of the EST tests complete, review test results by pressing each individual test listed on the left side of the GUI.
17.
Touch Exit Est .
18.
Touch Accept . The ventilator reruns POST and then displays the ventilator startup screen.
EST Test Step
Zero Offset
Leak Test
Mix Leak
Mix PSOL
Mix Accumulator
Circuit Pressure
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
Table 3-8. EST Test Sequence
•
Function
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
Required User
Interaction
Follow prompts
Follow prompts
Follow prompts
None
None
None
• Verify the autozero solenoid’s function
Verifies all flow sensors and PSOLs at specified flow volumes.
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
None
None
None
None
None
None
Operator’s Manual 3-47
Installation
EST Test Step
Backup Ventilation
Communication
Internal Storage
LCD Backlight
Status Display
GUI Alarms
BD Alarms
Rotary Knob Test
Offscreen Key Test
Ventilatory Battery
Compressor Battery
Compressor
Compressor Leak
Compressor Performance
Table 3-8. EST Test Sequence (Continued)
Function
Verifies backup ventilation systems: mix, inspiratory, and exhalation.
Verifies GUI communication ports function, both serial and ethernet.
Verifies internal storage device function.
Verifies GUI LCD backlight intensity function.
Verifies status display function
Required User
Interaction
None
None
None
None
None
• Verifies LCD function
Communicates with BD CPU •
• Communicates with compressor, if installed
Tests GUI alarm indicators, cycling through each alarm status indication.
Verifies BD audible alarm is functional. Also verifies power fail capacitor can operate loss-of-power alarm.
Verifies knob rotation function.
Verifies GUI bezel key function.
Tests ventilator battery and power distribution.
Run only if compressor installed
Tests compressor battery function, as well as compressor power system and fan function.
Tests overall compressor operation: pressure transducer, fan, motor, and pressure relief valve.
Checks compressor system for leaks.
Tests compressor operational performance under load.
Follow prompts
Follow prompts
Follow prompts
Follow prompts
Follow prompts
Follow prompts
Follow prompts
None
None
3-48 Operator’s Manual
Installation Testing
3.9.4
EST Test Results
Test Status
PASS
ALERT
FAIL
Table 3-9. Individual EST Results
Meaning
Individual EST test passed
Response
No need to do anything unless prompted by the ventilator
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.
Test still requires successful PASS.
When the system prompts, select:
REPEAT TEST,
NEXT TEST, or
STOP, then touch ACCEPT.
Select:
REPEAT TEST,
NEXT TEST, or
STOP, then touch ACCEPT.
Run all EST tests.
NEVER RUN
When EST completes all of the tests, analyze the results.
Final Outcome
PASS
ALERT
FAIL
Table 3-10. Overall EST Outcomes
Meaning
All EST tests passed
Response
EST successfully completed. Select other SERVICE MODE functions or prepare for SST tests prior to returning the ventilator for patient usage.
The ventilator detected one or more faults. The test result is not ideal, but is not critical.
One or more critical faults were detected. The ventilator enters the SVO state and cannot be used for normal ventilation until SST passes. Service is required.
ALERT status overridden by user.
When the system prompts, select:
REPEAT TEST,
NEXT TEST, or
STOP, then touch ACCEPT.
When the system prompts, select:
Repeat Test ,
Next Test , or
Stop , then touch Accept .
Select next desired test.
OVERRIDDEN
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.
Operator’s Manual 3-49
Installation
3.10
Operation Verification
Before ventilating a patient, you must perform SST and alarms tests with passing results
. Reference To run SST , p. 3-40. Reference
Alarm Testing , p. 6-8 as well.
3-50 Operator’s Manual
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
2
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
2
% 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.
4-1
4-2
Operation
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.
and Reference Connecting the Ventilator to the Gas Supplies , p. 3-7.
2.
Connect the patient circuit to the ventilator. Reference the figures on p. 3-14
to connect the adult/pediatric or neonatal patient circuits, respectively.
3.
Turn the ventilator ON using the power switch.
Reference Ventilator Power Switch and AC Indicator , p. 2-
4.
Before ventilating a patient, run SST to calculate the compliance and resistance with all items included in the patient circuit.
Reference To run SST , p. 3-40.
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
play.
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.
Operator’s Manual
The GUI is divided into several areas.
Figure 4-1. Areas of the GUI
User Interface Management
1.
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.
2.
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.
3.
Waveform area — Located in the center of the GUI screen. Shows various breath waveforms.
graphics.
4.
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
appear as solid colors (green during assist or control breaths and orange during spontaneous breaths).
Operator’s Manual 4-3
Operation
5.
Vital Patient data banner — Located across the top of the GUI screen. The patient data banner dis-
plays monitored patient data and can be configured to show desired patient data. Reference Vital
Patient Data , p. 3-35 for information on configuring patient data for display.
6.
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).
7.
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
2
), and help (question mark) icon. These icons are always visible regardless of the function selected on the GUI.
8.
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.
9.
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.
Reference Status Display , p. 2-25 for information about displayed items during Service mode.
4.4.2
Adjusting GUI Viewing Properties
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
38 for instructions on adjusting this feature.
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 4-2. Pushpin Icon
1 2
1 Pushpin icon – unpinned state 2 Pushpin icon – pinned state
4-4 Operator’s Manual
User Interface Management
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.
Display Brightness
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 five (5) seconds.
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. The following table explains gestures used with the GUI.
Operator’s Manual 4-5
Operation
Table 4-1. Gestures and Their Meanings
Gesture
Swipe
Double-tap
Drag
Touch and hold
Description
Quickly brush the screen surface with the fingertip.
Used for
Opening or closing dialogs or panels that slide in and out from the screen sides or top, moving waveform data, expanding or collapsing tooltips, scrolling lists, or alarm banners, maximizing or minimizing waveforms.
Rapidly touch the screen surface twice with one finger.
Move the fingertip over the screen surface without losing contact.
Maximizing or minimizing the viewable area of a dialog, control, or waveform, expanding or collapsing tooltips
Changing x- and y- axis scales, repositioning waveforms, moving the waveform cursor, moving scrollbars, scrolling lists. Scrolling speed varies depending upon how far outside the list boundary the finger is positioned.
Touch an item and hold for at least 0.5 seconds.
Displaying a tooltip dialog on whatever item is touched. The tooltip appears to glow indicating the touch and hold action.
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 anywhere 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 description of a tooltip. Double-tapping again minimizes the viewable waveform area or 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 reposition waveforms, touch and drag the graph to the new position.
To move the waveform cursor, 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
4-6 Operator’s Manual
Ventilator Operation
Gesture
Drag and drop
Table 4-1. Gestures and Their Meanings (Continued) (Continued)
Description
Touch and drag an item to another location and lift finger to drop.
Used for
Dragging help icon to describe an onscreen item.
How to Use
Drag the help icon, located at the lower right of the GUI screen, to the item in question and drop. If a blue glow appears, a tooltip is available and appears with information 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 graphical user interface (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/height entered, and circuit type used during SST. There is no prompt to review the settings and the waveforms display appears.
Operator’s Manual 4-7
Operation
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
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, nonitalic 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.
Reference Ventilator Settings Range and Resolution , p. 11-9 for default ventilator
parameter settings.
Figure 4-3. New Patient Settings
4-8
2.
Enter the patient’s PBW or gender and height (if gender is selected, the height selection becomes available).
Operator’s Manual
Ventilator Operation
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 change(s).
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.
Reference Predicted Body Weight (PBW) Calculation , p. 4-18.
•
• 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. Reference Non-invasive Ventilation (NIV) , p. 4-19
Mode — Specify the breathing mode (A/C (assist/control), SIMV (synchronous intermittent mandatory ventilation), SPONT (spontaneous ventilation), BiLevel (if the BiLevel option is installed), 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) (if the PAV+ software option is installed).
Note:
VS, PAV+, and TC are only available during INVASIVE ventilation.
• Trigger type — Select pressure- triggering (P
TRIG
) or flow-triggering (
V
TRIG
). Pressure-triggering is not available when vent 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 at the bottom left of the GUI display
Operator’s Manual 4-9
Operation
• Swipe the menu tab on the left side of the GUI and touch Setup
Figure 4-4. Open Menu Tab
1 Setup button
Figure 4-5. New Patient Setup Screen
4-10
1.
Select Vent type, Mode, Mandatory type, Spontaneous type and Trigger type by touching the corresponding button.
2.
Touch the ventilator setting button needing changes.
Operator’s Manual
Ventilator Operation
3.
Adjust the setting value.
4.
Continue in this manner until all changes are made, then touch Accept or Accept ALL .
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.
Reference Waveforms , p. 3-37 for information on setting up the graphics display.
If changes to any settings are required, return to the Vent Setup screen as described above.
Note:
A yellow triangle icon appears on tabs and buttons displayed on the GUI containing unread or un-viewed 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 above. 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.
Tube Compensation
Tube Compensation 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
To enable TC
1.
Touch the Vent
tab on the GUI screen. Reference New Patient Setup Screen , p. 4-10.
2.
Touch SPONT for the mode selection.
3.
Touch TC for Spontaneous type.
4.
Finish setting up the ventilator as described (reference
p. 4-10 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.
Operator’s Manual 4-11
Operation
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.
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.
A Humidifier Volume button appears below the selection only if Non-Heated Expiratory Tub e 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.
lists the allowable ventilator settings according to patient type and ventilation type.
4-12 Operator’s Manual
Ventilator Operation
Table 4-2. Allowable Ventilator Settings
Patient type
Ventilation type
Mode
Invasive
Adult
NIV Invasive
Pediatric
NIV Invasive
Neonatal
NIV
A/C, SIMV,
SPONT, BiLevel
PC, VC, VC+
A/C, SIMV,
SPONT
PC, VC
A/C, SIMV,
SPONT, BiLevel
PC, VC, VC+
A/C, SIMV,
SPONT
PC, VC
A/C, SIMV,
SPONT,
BiLevel
PC, VC, VC+
A/C, SIMV,
SPONT, CPAP
PC, VC Mandatory type
Spontaneous type
Trigger type
PS PS, TC, (≥7.0 kg), VS
V
TRIG
, P-Trig
PS PS, VS PS PS, TC, VS,
PAV+ (≥25 kg)
V
TRIG
, P-Trig
V
TRIG
V
TRIG
V
TRIG
V
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
I
, T
I
O
2
%, and T
A
.
Volume-controlled apnea breath parameters are f , V
T
, V
MAX
, Flow pattern, O
2
%, and T
A
.
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.
Operator’s Manual 4-13
Operation
Figure 4-6. Apnea Setup Screen
4-14 need new screenshot
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
I
.
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. Reference Alarms Settings Screen , p. 4-15. 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:
Reference Alarm Settings Range and Resolution , p. 11-16 for new patient default alarm values. These
defaults cannot be changed. The clinician can adjust alarm settings by following the procedure below.
The alarm settings are retained in memory when the ventilator’s power is cycled, and current settings revert to new patient defaults when a new patient is selected.
Operator’s Manual
Figure 4-7. Alarms Settings Screen
Ventilator Operation
2
1
To adjust the alarm settings
1.
Touch each alarm setting slider of the alarm(s) to change. Alarm settings are available for P
PEAK
, f
TOT
,
V
E TOT
, V
TE MAND
, V
TE SPONT
, and V
TI
parameters.
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
(
2
V
TI
). This alarm condition occurs when the inspired tidal volume is larger than the setting value. A
1
V
TI alarm will also cause breath delivery to transition to the exhalation 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.
Reference To adjust alarm volume , p. 3-35 to ensure alarm volume is adjusted properly.
Operator’s Manual 4-15
Operation
Note:
A sample alarm tone sounds for verification at each volume level change. Re-adjust 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 (item 1), the parameter alarm settings (items 2 and
3), recent range of patient data values for the last 200 breaths (item 4). If an alarm occurs, the slider
and corresponding limit button show a color matching the alarm’s priority. Reference Alarm
Screen During Operation , p. 4-16.
Figure 4-8. Alarm Screen during Operation
4-16
1 Pointers show current value of patient data corresponding to the alarm parameter
2 High alarm setting (in this case
2
V
TE SPONT
)
3 Low alarm setting (in this case
4
V
TE SPONT
)
4 Range of patient data values for the particular parameter during the last 200 breaths
Operator’s Manual
Ventilator Operation
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
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 Vent Setup .
2.
Change the settings as described previously.
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 five (5) minutes or less. If the power loss lasts longer than five minutes, ventilation resumes in Safety PCV. Ventilator and alarm settings must be reset for the patient being ventilated.
Reference Safety PCV Settings , p. 10-60 for a list of these settings.
To use the Previous Setup button
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 re-appears 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 VMAX 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
I:E ratio, or T
E
as the constant
Operator’s Manual 4-17
Operation variable during rate changes (or T
H
, T
H
:T
L
ratio, or T
L
in BiLevel). If the ventilation mode is SPONT, the padlock icons do not appear, and the breath timing graph only displays T
I
for a manual inspiration. If the mandatory type is VC, the icons do not appear, but the breath timing graph displays
T
I
, I:E ratio, and T
E
.
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 least3.5 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 Fenton tables provided the exclusive information for premature and infant data between 20 weeks and 50 weeks of fetal and gestational growth.
123
4-18
1.
Fenton TR, BMC Pediatrics 2003, 3:13. http://www.biomedcentral.com/1471-2431/3/13.
2.
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.
3.
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.
Operator’s Manual
Non-invasive Ventilation (NIV)
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
TE
) could differ from the ventilator’s monitored patient data V
TE
reading due to leaks around the mask. To avoid this, ensure Leak Sync
is installed. When NIV is selected, Leak Sync is automatically enabled. Reference To enable Leak
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
Covidien has successfully tested the following non-vented interfaces with NIV:
Full-face Mask — Puritan Bennett
®
Benefit Full Face Mask (large), ResMed Mirage™ Non-Vented Full Face
Mask (medium)
Nasal Mask — ResMed Ultra Mirage™ Non-vented Mask (medium)
Infant Nasal Prongs — Sherwood Davis & Geck Argyle
®
CPAP Nasal Cannula (small), Hudson RCI
®
Infant
Nasal CPAP System (No. 3)
Uncuffed neonatal ET tube — Shiley Uncuffed Tracheal Tube, Murphy
(3.0 mm)
Operator’s Manual 4-19
Operation
4.7.3
NIV Setup
NIV can be initiated from either the New Patient Setup screen during Vent start-up or while the patient is being ventilated invasively. Reference the table below for using NIV patient setup information.
Table 4-3. Setting Up a Patient for NIV
1.
4.
5.
2.
3.
6.
7.
To set up a new patient
Turn the ventilator on.
Select New Patient.
Enter patient’s PBW or gender and height.
2.
3.
Touch NIV vent type.
Select mode.
Select mandatory type.
Complete ventilator settings, including apnea and alarm settings.
1.
To set up a patient currently being ventilated
Touch or swipe the menu tab on the left side of the
GUI.
4.
Touch Vent Setup .
Perform steps 4 through 7 as if setting the ventilator up for a new patient.
Review the settings, including apnea and alarm settings and change if necessary.
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.
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.
4.7.4
Conversion from INVASIVE to NIV Vent Type
WARNING:
For proper ventilation when changing the Vent 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. Reference the following table for automatic settings changes when changing vent type from INVASIVE to NIV.
4-20 Operator’s Manual
Non-invasive Ventilation (NIV)
Table 4-4. 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
Alarm settings:
4
P
PEAK
(if applicable),
4V
E TOT
,
4
V
TE
MAND
,
4
V
TE SPONT
INSPIRATION TOO LONG (not usersettable)
D
SENS
New NIV setting
Breath mode: A/C
High T
I SPONT
(
2
T
I SPONT
limit setting available
Mandatory type:
Neonatal: PC
Adult/Pediatric: VC
Spontaneous type: PS
Trigger type: Flow
(Flow triggering is the only allowable trigger type during NIV)
Alarm settings:
4
P
PEAK
,
4V
E TOT
4
V
TE MAND
,
4
V
TE
SPONT
default to NIV new patient values. Reference
Alarm Settings Range and Resolution , p. 11-16. INSPI-
RATION TOO LONG alarm not available.
D
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
O, there is always a target inspiratory pressure of 1.5 cmH
2
O applied.
When in NIV, the Vent Setup button’s appearance changes, letting the operator know the vent type is NIV.
Operator’s Manual 4-21
Operation
Figure 4-9. Vent Setup Button “NIV” Indicating NIV vent type
4.7.5
Conversion from NIV to INVASIVE Vent Type
The table below shows automatic settings changes made when changing vent type from NIV to
INVASIVE.
Table 4-5. NIV to INVASIVE on Same Patient
New INVASIVE setting Current NIV setting
Ventilator settings:
2
T
I SPONT
Alarm settings:
4
P
PEAK
,
4V
E TOT
,
4
V
TE MAND
,
4
V
TE SPONT
N/A
D
SENS
Alarm settings: Default to new patient values depen-
INSPIRATION TOO LONG alarm becomes available.
D
SENS
setting defaults to INVASIVE new patient
value. Reference Ventilator Settings Range and Resolution , p. 11-9.
4-22
4.7.6
High Spontaneous Inspiratory Time Limit Setting
NIV includes a setting in SIMV or SPONT modes for High Spontaneous Inspiratory Time limit ( 2 T
I
SPONT
). When a patient’s inspiratory time reaches or exceeds the set limit, the ventilator transitions from inspiration to exhalation, and the 1 T
I SPONT
symbol appears at the lower left on the GUI
Operator’s Manual
Non-invasive Ventilation (NIV) screen, indicating the ventilator has truncated the breath (shown below). The 2 T
I SPONT
) setting does not restrict changes to PBW; if the PBW is decreased, 2 T
I SPONT
) may decrease automatically to remain within its allowable limits.
Figure 4-10.
2
T
I SPONT
Indicator
WARNING:
No audible alarm sounds in conjunction with the visual
2
T
I SPONT
indicator, nor does the indicator appear in any alarm log or alarm message.
It is possible the target inspiratory pressure may not be reached if the 2 T
I SPONT
setting is not long enough, or if system leaks are so large as to cause the ventilator to truncate the breath at the maximum allowable 2 T
I SPONT
setting.
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
apnea parameters are set.
Operator’s Manual 4-23
Operation
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.
Figure 4-11. Default NIV Alarm Settings
4-24
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. Reference Default NIV Alarm
Reference Alarm Prioritization , p. 6-14 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 (including mixed modes BiLevel and SIMV), the ventilator delivers the manual inspiration using the currently set mandatory breath parameters. A manual inspiration performed while the
Operator’s Manual
Respiratory Mechanics Maneuvers ventilator is in the SPONT mode uses the currently set apnea breath parameters. A volume-based manual inspiration is compliance-compensated. Pressing the manual inspiration key while in
BiLevel mode will transition from T
H
to T
L
or T
L
to T
H
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 .
Figure 4-12. RM in Menu Tab
3.
Touch the particular tab for the desired maneuver.
Operator’s Manual 4-25
Operation
Figure 4-13. Respiratory Maneuver Tabs
4-26
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 in order to calculate inspiratory Plateau Pressure (P
PL
), 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 no-flow state. A request for an inspiratory pause is ignored during apnea ventilation, safety PCV, OSC, BUV, and in Standby 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 seven 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 above. The ventilator performs the inspiratory pause maneuver and displays P
PL
, 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.
Operator’s Manual
Respiratory Mechanics Maneuvers
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
PL
, 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
L
) 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 exhalation 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
I
) to be calculated. PEEP
I
is PEEP
L
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 endof-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
L
to P
H
. During the expiratory pause maneuver, PEEP
I
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
A
is extended by the amount of time the pause is active. Expiratory pause 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 three (3) seconds for an automatic expiratory pause.
During a manual or automatic expiratory pause, PEEP
I
and PEEP
L
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
1.
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
L
, and PEEP
I
, along with the date and time.
Operator’s Manual 4-27
Operation
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
L
, and PEEP
I
, along with the date and time.
2.
Accept or reject the pause results.
To cancel an expiratory pause maneuver
1.
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
2
%. 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).
Reference the Puritan Bennett™ 980 Series Ventilator Service Manual for instructions on replacing the O
2
sensor.
•
New patient default O
2
% settings are as follows:
O
2
sensor enabled
Neonatal: 40% O
2
• Pediatric/adult: 100% O
2
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
2
sensor
1.
Touch Vent Setup .
2.
Touch the More Settings tab. The more settings screen appears.
4-28 Operator’s Manual
Figure 4-14. More Settings Screen with O
2
Sensor Enabled
Oxygen Sensor Function
3.
Touch the button corresponding to the desired O
2
sensor function ( Enable or Disable ).
4.
Touch Accept .
4.10.1
Oxygen Sensor Life
The O
2
% setting can range from room air (21% O
2
) 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 O
2
% alarm annunciation. Once a calibrated oxygen sensor and the ventilator reach a steady-state operating temperature, the monitored O
2
% 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
2
analyzer in conjunction with the information given by the ventilator. If a NO O
2
SUPPLY alarm occurs, compare the O
2
analyzer reading with the ventilator’s O
2 reading for troubleshooting purposes. The ventilator automatically switches to 100% air delivery.
Operator’s Manual 4-29
Operation
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
2
sensor calibration.
To calibrate the O
2
sensor
1.
Touch Vent Setup .
2.
Touch the More Settings tab.
3.
Touch Calibrate for the O
2
sensor. The calibration procedure results in 100% O
2
being delivered
4.10.3
Oxygen sensor calibration testing
To test the O
2
sensor calibration
1.
Connect the ventilator’s oxygen hose to a known 100% O
2
source (for example, a medical-grade oxygen cylinder).
2.
Calibrate the oxygen sensor as described above.
3.
Connect the ventilator oxygen hose to another known 100% O
2
source (for example, a second medical-grade oxygen cylinder).
4.
Set O
2
% to each of the following values, and allow one minute after each for the monitored value to stabilize: 21%, 40%, 90%
5.
Watch the GUI screen to ensure the value for O
2
(delivered O
2
%) is within 3% of each setting within one minute of selecting each setting.
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 descriptions below 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. Reference 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. Reference DEVICE ALERT Alarm , p. 6-31 for more information.
4-30 Operator’s Manual
Ventilator Protection Strategies
4.11.2
Technical Fault
tilate 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. Reference Safety PCV Settings , p. 10-60.
4.11.5
Ventilation Assurance
During ventilation, the ventilator performs frequent background checks of its breath delivery subsys-
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
lation 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 condi-
Operator’s Manual 4-31
Operation tion 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 and a Vent Inop indicator illuminates and 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. Reference
Ventilator Logs , p. 8-2 for information on ventilator logs.
4-32 Operator’s Manual
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. Reference Waveforms , p. 3-37 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)
5-1
5-2
Product Data Output
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 9-1. is the ONLY compatible USB device
currently available for use on the PB980. To order a compatible USB device, contact Covidien
Technical Services at 800 255 6774 or contact a local Covidien 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 (10) 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.
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.
Reference Open Menu Tab , p. 4-10.
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.
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
Operator’s Manual
Figure 5-1. Incompatible USB Device Message
Data Transfer
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. 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, Philips, Spacelabs, or Waveforms.
Operator’s Manual 5-3
Product Data Output
Figure 5-2. Comm Setup Screen
5-4
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. Reference Port Locations , p. 5-16 for a
description and the locations of the Comm ports.
Operator’s Manual
Data Transfer
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
Covidien 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. For longer duration breaths, at least the first eight 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: Reference RSET Command , p. 5-5.
SNDA: Reference SNDA Command , p. 5-5.
•
SNDF: Reference SNDF Command , p. 5-9.
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.
Operator’s Manual 5-5
Product Data Output
The MISCA response follows this format:
MISCA
1
706 97
2 3
<STX>
4
FIELD 5, … FIELD 101,
5
<ETX>
6
<CR>
7
1 Response code to SNDA command 5 Data field, left-justified and padded with spaces
End of transmission (03 hex) 2
3
Number of bytes between <STX> and
<CR>
Number of data fields between <STX> and <ETX>
Start of transmission (02 hex)
6
7 Terminating carriage return
4
Fields not available are marked as “Not used.” Underscores represent one or more spaces that pad each character string.
The table below lists MISCA responses to SNDA commands.
Field 7
Field 8
Field 9
Field 10
Field 11
Field 12
Field 13
Field 14
Field 15
Field 16
Component
MISCA
706
97
<STX>
Field 5
Field 6
Table 5-1. MISCA Response
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)
Ventilator ID to allow external hosts to uniquely identify each Puritan Bennett™ 980
Ventilator (18 characters)
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)
O
2
% setting (6 characters)
Pressure sensitivity setting in cmH
2
O (6 characters)
PEEP or P
L
(in BiLevel) setting in cmH
2
O (6 characters)
Plateau time in seconds (6 characters)
5-6 Operator’s Manual
Operator’s Manual
Field 42
Field 43-44
Field 45
Field 46
Field 47
Field 48
Field 49-50
Field 51
Field31-33
Field 34
Field 35
Field 36
Field 37
Field 38
Field 39
Field 40
Field 41
Component
Field 17-20
Field 21
Field 22
Field 23
Field 24
Field 25
Field 26
Field 27
Field 28-29
Field 30
Field 52
Field 53
Table 5-1. MISCA Response (Continued)
Description
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
2
% setting (6 characters)
Pressure support setting in cmH
2
O (6 characters)
Flow pattern setting (SQUARE or RAMP__) (6 characters)
Not used (6 characters)
Elevate O
2
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
2
O (6 characters)
Mean airway pressure in cmH
2
O (6 characters)
End inspiratory pressure in cmH
2
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
2
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)
Low exhaled minute volume alarm status (NORMAL, ALARM_, or RESET_) (6 characters)
High respiratory rate alarm status (NORMAL, ALARM_, or RESET_) (6 characters)
Data Transfer
5-7
Product Data Output
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 64
Field 65
Field 66
Field 67
Field 68
Field 69
Field 70
Component
Field 54
Field 55
Field 56
Field 57
Field 58-59
Field 60
Field 61
Field 62
Field 63
Table 5-1. MISCA Response (Continued)
Description
No O
2
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
2
O(6 characters)
Static resistance (R
STAT
) from inspiratory pause maneuver in cmH
2
O/L/s (6 characters)
Dynamic compliance (C
DYN
) in mL/cmH
2
O (6 characters)
Dynamic resistance (R
DYN
) in cmH
2
O/L/s (6 characters)
Negative inspiratory force (NIF) in cmH
2
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 incmH
2
O (6 characters)
Inspiratory pressure or P
H
setting in cmH
2
O (6 characters)
Inspiratory time or T
H
setting in seconds (6 characters)
Apnea interval setting in seconds (6 characters)
Apnea inspiratory pressure setting in cmH
2
O (6 characters)
Apnea respiratory rate setting in breaths per minute (6 characters)
Apnea inspiratory time setting in seconds (6 characters)
Apnea O
2
% setting (6 characters)
Apnea high circuit pressure limit in cmH
2
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)
5-8 Operator’s Manual
Data Transfer
Component
Field 96
Field 97
Field 98
Field 99
Field 100
Field 101
<ETX>
<CR>
Table 5-1. MISCA Response (Continued)
Description
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
E or PCV not active)
Monitored value of I:E ratio (6 characters)
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
1
1225* 169
2 3
<STX>
4
FIELD 5, … FIELD 169,
5
<ETX>
6
<CR>
7
1 Response code to SNDF command 5 Data field, left-justified and padded with spaces
End of transmission (03 hex) 2
3
Number of bytes between <STX> and
<CR>
Number of data fields between <STX> and <ETX>
Start of transmission (02 hex)
6
7 Terminating carriage return
4 * 1229 if Philips is selected for serial port in communication setup
The table below lists MISCF responses to SNDF commands
Operator’s Manual 5-9
Product Data Output
Note:
Non-applicable fields will either contain zero or be blank.
Field 7
Field 8
Field 9
Field 10
Field 11
Field 12
Field 13
Field 14
Field 15
Field 16
Field 17
Field 18
Field 19
Field 20
Field 21
Field 22
Field 23
Field 24
Field 25
Field 26
Component
MISCF
1225*
169
<STX>
Field 5
Field 6
Table 5-2. MISCF Response
Description
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
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
Ventilator (18 characters)
Date (MMM_DD_YYYY_) (12 characters)
Vent Type (NIV______ or INVASIVE_) (9 characters)
Mode (A/C___, SIMV__, SPONT_ or CPAP) (6 characters)
Mandatory Type (PC____, VC____, VC+___) (6 characters)
Spontaneous Type (PS____, TC____, VS____, PA____ (6 characters)
Trigger Type setting (
V
TRIG
, P
TRIG
) (6 characters)
Respiratory rate setting in breaths/min (6 characters)
Tidal volume (V
T
) setting in L (6 characters)
Peak flow (
V
MAX
) setting in L/min (6 characters)
O
2
% setting (6 characters)
Pressure sensitivity setting in cmH
2
O (6 characters)
PEEP/CPAP in cmH
2
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
2
% setting (6 characters)
PCV apnea inspiratory pressure setting in cmH
2
O (6 characters)
PCV Apnea Inspiratory Time setting in seconds (6 characters)
5-10 Operator’s Manual
Operator’s Manual
Field 42
Field 43
Field 44
Field 45
Field 46
Field 47
Field 48
Component
Field 27
Field 28
Field 29
Field 30
Field 31
Field 32
Field 33
Field 34
Field 35
Field 36
Field 37
Field 38
Field 39
Field 40
Field 41
Field 49
Field 50
Field 51
Field 52
Table 5-2. MISCF Response (Continued)
Description
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
2
O)
Flow pattern setting (SQUARE or RAMP) (6 characters)
Elevate O
2
state (ON or OFF) (6 characters)
High inspiratory pressure alarm setting (
2
P
PEAK
) in cmH
2
O (6 characters)
Low inspiratory pressure alarm setting (
4
P
PEAK
) in cmH
2
O or OFF (6 characters)
High exhaled minute volume (
2V
E TOT
) alarm setting in L/min or OFF (6 characters)
Low exhaled minute volume (
4V
E TOT
) alarm setting in L/min or OFF (6 characters)
High exhaled mandatory tidal volume (
2
V
TE MAND
) alarm setting in mL or OFF
(6 characters)
Low exhaled mandatory tidal volume (
4
V
TE MAND
) alarm setting in mL or OFF
(6 characters)
High exhaled spontaneous tidal volume (
2
V
TE SPONT
alarm setting in mL or OFF
(6 characters)
Low exhaled spontaneous tidal volume (
4
V
TE SPONT
) alarm setting in mL or OFF
(6 characters)
High respiratory rate (
2 f
TOT
) alarm setting in breaths/min or OFF (6 characters)
High inspired tidal volume (
2
V
TI
) alarm setting in mL (6 characters)
Base flow setting in L/min (6 characters)
Flow sensitivity (
V
SENS
) setting in L/min (6 characters)
PCV inspiratory pressure (P
I
) setting in cmH
2
O (6 characters)
PCV inspiratory time (T
I
) 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)
Tube Type setting (ET or TRACH) (6 characters)
Data Transfer
5-11
Product Data Output
Field 54
Field 55
Field 56
Field 57
Field 58
Field 59
Field 60
Field 61
Field 62
Field 63
Field 64
Field 65
Field 66
Field 67
Field 68
Field 69
Field 70
Field 71
Field 72
Field 73
Field 74
Field 75
Component
Field 53
Field 76
Field 77
Field 78
Field 79
Field 80
Table 5-2. MISCF Response (Continued)
Description
Humidification type setting (Non-heated exp tube, Heated exp tube, or HME)
(18 characters)
Humidifier volume setting in L (6 characters)
O
2 sensor setting (Enabled or Disabled) (9 characters)
Disconnect sensitivity (D
SENS
) setting in % 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
H
) setting (in BiLevel) in cmH
2
O (6 characters)
Low pressure (P
L
) setting (in BiLevel) in cmH
2
O (6 characters)
High pressure time (T
H
) setting (in BiLevel) in seconds (6 characters)
High spontaneous inspiratory time limit (
2
T
I SPONT
) setting in seconds (6 characters)
Circuit type setting (ADULT or PEDIATRIC) (9 characters)
Low pressure time (T
L
) setting (in BiLevel) in seconds (6 characters)
Expiratory time (T
E
) setting in seconds (6 characters)
End inspiratory pressure (P
I END
) in cmH
2
O (6 characters)
Respiratory rate (f
TOT
) in breaths/min (6 characters)
Exhaled tidal volume (V
TE
) in L (6 characters)
Patient exhaled minute volume (
V
E TOT
) in L/min (6 characters)
Peak airway pressure (P
PEAK
) in cmH
2
O (6 characters)
Mean airway pressure (P
MEAN
) in cmH
2
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
2
% (6 characters)
Inspired tidal volume (V
TI
) in L (6 characters)
Intrinsic PEEP (PEEP
I
) in cmH
2
O (6 characters)
Estimated total resistance (R
TOT
) in cmH
2
O/L/s (6 characters)
5-12 Operator’s Manual
Operator’s Manual
Table 5-2. MISCF Response (Continued)
Component
Field 81
Field 82
Field 83
Description
Estimated patient resistance (R
PAV
) in cmH
2
O/L/s (6 characters)
Estimated patient elastance (E
PAV
) in cmH
2
O/L (6 characters)
Estimated patient compliance (C
PAV
) in mL/cmH
2
O (6 characters)
Not used Field 84
Field 85
Field 86
Field 87
Field 88
Field 89
Field 90
Field 91
Field 92
Field 93
Field 94
Rapid shallow breathing index ( f /V
T
) (6 characters)
Spontaneous percent inspiratory time (T
I
/T
TOT
) (6 characters)
Monitored PEEP in cmH
2
O (6 characters)
Spontaneous inspiratory time (T
I SPONT
) in seconds (6 characters)
Exhaled spontaneous minute volume (
V
E SPONT
) in L/min (6 characters)
Intrinsic PEEP (PEEP
I
) from expiratory pause maneuver in cmH
2
O (6 characters)
Total PEEP (PEEP
L
from expiratory pause maneuver in cmH
2
O (6 characters)
Static compliance (C
STAT
) from inspiratory pause maneuver in mL/cmH
2
O
(6 characters)
Static resistance (R
STAT
) from inspiratory pause maneuver in cmH
2
O/L/s (6 characters)
Plateau pressure (P
PL
) from inspiratory pause maneuver in cmH
2
O (6 characters)
High spontaneous inspiratory time (ALERT_ or blank) (6 characters) Field 95
Field 96
Field 97
Field 98
Field 99
Field 100
Field 101
Field 102
Field 103
Dynamic compliance (C
DYN
) in mL/cmH
2
O (6 characters)
Dynamic resistance (R
DYN
) in cmH
2
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)
Reserved
Negative inspiratory force (NIF) in cmH
2
O (6 characters)
P
0.1
pressure change in cmH
2
O (6 characters)
Vital capacity (VC) in L (6 characters) Field 104
Field 105
Field 106
Field 107
Field 108
Audio paused (ON or OFF) (6 characters)
Apnea ventilation alarm* (6 characters)
High exhaled minute volume alarm* (
1V
E TOT
) (6 characters)
High exhaled tidal volume alarm* (
1
V
TE
) (6 characters)
* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.
Data Transfer
5-13
Product Data Output
Table 5-2. MISCF Response (Continued)
Component
Field 109
Field 110
Field 111
Field 112
Field 113
Field 114
Field 115
Field 116
Field 117
Field 118
Field 119
Field 120
Description
High O
2
% alarm* (6 characters)
High inspiratory pressure alarm* (
1
P
PEAK
) (6 characters)
High ventilator pressure alarm* (
1
P
VENT
) (6 characters)
High respiratory rate alarm* (
1 f
TOT
) (6 characters)
AC power loss alarm* (6 characters)
Inoperative battery alarm* (6 characters)
Low battery alarm* (6 characters)
Loss of power alarm* (6 characters)
Low exhaled mandatory tidal volume alarm* (
3
V
TE MAND
) (6 characters)
Low exhaled minute volume alarm* (
3V
E TOT
) (6 characters)
Low exhaled spontaneous tidal volume (
3
V
TE SPONT
) alarm* (6 characters)
Low O
2
% alarm* (6 characters)
Low air supply pressure alarm* (6 characters) Field 121
Field 122
Field 123
Field 124
Field 125
Field 126
Field 127
Field 128
Low O
2
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)
Field 129
Field 130
Field 131
Procedure error* (6 characters)
Compliance limited tidal volume (V
T
) alarm* (6 characters)
High inspired spontaneous tidal volume* (
3
T
I SPONT
) alarm (6 characters)
Reserved
High compensation limit (
1
P
COMP
) alarm* (6 characters)
PAV+ startup too long alarm* (6 characters)
PAV+ R and C not assessed alarm* (6 characters)
Field 132
Field 133
Field 134
Field 135
Field 136
Volume not delivered (VC+ alarm* (6 characters)
Volume not delivered (VS) alarm* (6 characters)
Low inspiratory pressure (
3
P
PEAK
) alarm* (6 characters)
Field 137 Technical malfunction A5* (6 characters)
* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.
5-14 Operator’s Manual
Operator’s Manual
Table 5-2. MISCF Response (Continued)
Component
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
Description
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)
Field 151
Field 152
Field 153
Field 154
Field 155
Technical malfunction A75* (6 characters)
Technical malfunction A80* (6 characters)
Technical malfunction A85* (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) Field 156
Field 157
Field 158
Field 159
Field 160
Field 161
%LEAK (6 characters)
LEAK (6 characters)
VLEAK (6 characters)
Prox Inop alarm* (ALARM or NORMAL)
Field 162-173
<ETX>
ETCO
2
when COM port is set to DCI 2.0 (6 characters)
Reserved
End of transmission character (03 hex)
<CR> Terminating carriage return
* Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET.
Data Transfer
5-15
Product Data Output
5.5
Communication Ports
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 nonclinical ports listed below when the ventilator is ventilating a patient.
Figure 5-3. Port Locations
5-16
5
6
7
3
4
1
2
RS-232 Port (COM 1)
Ethernet Port (non-clinical use)
Nurse call Port (remote alarm port)
USB Port (USB 1) (COM 2) (non-clinical use)
USB Port (USB 2) (COM 3) (non-clinical use)
HDMI Port (non-clinical use)
Service Port (non-clinical use)
Operator’s Manual
Communication Ports
5.5.1
Port Use
Reference Data Transfer , p. 5-1 for information on data transfer details.
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.
, p. 5-6 and MISCF Response , p. 5-10 for MISCA and MISCF responses to
SNDA and SNDF commands.
Ethernet Port
The Ethernet port is used by Service personnel for accessing various logs and updating ventilator software.
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
Reference the remote alarm manufacturer’s instructions for use for information regarding proper nurse call connection.
USB Ports
The USB ports are used for screen captures, or receiving serial data when a USB port has been con-
external USB memory storage device (“flash drive”) for screen captures. Instructions for using this
port for screen captures are given. Reference To capture GUI screens , p. 5-2.
Operator’s Manual 5-17
Product Data Output
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 (item 6, above).
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.
Service Port
The Service port is used by service personnel 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 Covidien personnel when the ventilator is in Service mode.
Reference Ventilator Logs , p. 8-2 for more information on data stored
in various logs.
5.7
Display Configurability
by whom.
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.
Reference GUI Screen Capture , p. 5-2 for instructions on using the screen-capture feature.
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.
5-18 Operator’s Manual
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 options are available for the ventilator. Details for each of these 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. Reference Environmental
Specifications , p. 11-8 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.
6-1
Performance
6.4.1
Ventilation Type
The clinician enters the vent type, specifying how the patient will be ventilated; invasively or noninvasively (NIV). The vent 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
L
and P
H
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 vent type is NIV. CPAP mode allows spontaneous breathing with a desired PEEP level. In order 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.
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 condi-
tions. Reference Mandatory Breath Delivery , p. 10-13 for more information on VC+.
Mandatory inspirations are triggered in the following ways:
6-2 Operator’s Manual
Ventilator Settings
•
•
•
•
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
, the ventilator delivers a breath.
Flow Trigger ( V
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 ( V
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 option that allows the ventilator to reduce the work of breathing (WOB) by assisting the patient’s inspiration by an operator-set amount propor-
tional to the pressure generated by the patient. Reference Appendix C 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 ( V
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.
Operator’s Manual 6-3
6-4
Performance
6.5
Alarms
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:
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.
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 ( 1 or 3 ) preceding the specific alarm name. An alarm setting is denoted as an upward or downward pointing arrow with an additional horizontal limit symbol
( 2 or 4 ) preceding the specific alarm. Some alarm conditions actually limit breath delivery such as
1 P
PEAK
and 1 V
TI
by truncating inspiration and transitioning to the exhalation phase. These alarm conditions are denoted as alarm limits
. Reference Alarm Descriptions and Symbols , p. 6-6.
6.5.1
Alarm Messages
Alarms are visually annunciated using an indicator on the top of the GUI, which has a 360° field of view. 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. If an alarm occurs, this indicator appears in the color matching the alarm priority (yellow for low (!) and medium (!!) priority; red for high (!!!) priority. For technical alarm and non-technical alarm details, reference the respective tables on
and
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. The figure below, shows the alarm message format.
Operator’s Manual
Figure 6-1. Alarm Message Format
Alarms
3 Remedy message 1
2
Base message
Analysis 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 lockable alarm 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 silenced.
•
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.
Operator’s Manual 6-5
Performance
•
•
•
•
•
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 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 6-1. 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
Symbol
1 P
COMP
1 O
2
%
1V
E TOT
2V
E TOT
1 V
TE
2 V
TE
2 V
TI
1 P
VENT
1 f
TOT
2 f
TOT
1
T
I SPONT
2
T
I SPONT
1
P
PEAK
2
P
PEAK
3 P
PEAK
4 P
PEAK
3
V
TE MAND
4 V
TE MAND
6-6 Operator’s Manual
Alarms
Table 6-1. Alarm Descriptions and Symbols (Continued)
Alarm description
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
3V
E TOT
4V
E TOT
3 V
TE SPONT
4 V
TE SPONT
3 O
2
%
6.5.2
Alarm Reset Key
The alarm reset function can be used for any non-technical alarm.
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
2
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 again. The ventilator logs all actuations of the alarm reset key.
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 two minutes.
After the two-minute period, if the alarm condition still exists, the alarm sounds again. Pressing the audio paused key again re-starts the two 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 two 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
Operator’s Manual 6-7
6-8
Performance 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 (1) 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.
Reference To adjust alarm volume , p. 3-35 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
6.5.5
Alarm Testing
•
Testing the alarms requires oxygen and air sources and stable AC power. Test the alarms at least every six 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 ( 3 V
TE MAND
)
LOW EXHALED TOTAL MINUTE VOLUME ( 3V
E TOT
)
HIGH CIRCUIT PRESSURE ( 1 P
PEAK
)
SEVERE OCCLUSION
AC POWER LOSS
APNEA
LOW EXHALED SPONTANEOUS TIDAL VOLUME ( 3 V
TE SPONT
)
NO O
2
SUPPLY
LOW DELIVERED O
2
% ( 3 O
2
%)
HIGH DELIVERED O
2
% ( 1 O
2
%)
Operator’s Manual
Alarms
Ventilator setup for alarms tests
1.
Disconnect the patient circuit from the ventilator and turn the ventilator off for at least five 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.
5.
PBW : 70 kg
Vent type : INVASIVE
Mode : A/C
Mandatory type : VC
Trigger type : V
TRIG
Set the following new patient settings
6.
f : 6.0 1/min
V
T
: 500 mL
V
MAX
: 30 L/min
T
PL
: 0 s
Flow pattern : SQUARE
V
SENS
: 3 L/min
O
2
% : 21%
PEEP : 5 cmH
2
O
Set the following apnea settings
7.
T
A
: 10 s f : 6.0 1/min
O
2
% : 21%
V
T
: 500 mL
Set the following alarm settings
2 P
PEAK
: 70 cmH
2
O f
TOT
: OFF
4V
E TOT
: 1 L/min
2V
E TOT
: 3.5 L/min
4 V
TE MAND
: 300 mL
2 V
TE MAND
: OFF
4 V
TE SPONT
: OFF
Operator’s Manual 6-9
Performance
8.
2 V
TE SPONT
: OFF
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.
LOW EXHALED MANDATORY TIDAL VOLUME ( 3 V
TE MAND
) alarm test
Set V
T
to 225 mL. The ventilator annunciates a LOW EXHALED MANDATORY TIDAL VOLUME ( 3 V
TE
MAND
) alarm on the third consecutive breath after Accept is touched.
LOW EXHALED TOTAL MINUTE VOLUME ( 3V
E TOT
alarm test
Set 4V
E TOT
alarm limit to 3.45 L/min. The ventilator annunciates a LOW EXHALED TOTAL MINUTE
VOLUME ( 3V
E TOT
) alarm on the next breath after Accept is touched.
HIGH CIRCUIT PRESSURE ( 1 P
PEAK
) alarm test
1.
Make the following patient and alarm settings changes.
2.
V
T
: 500 mL
V
MAX
: 30 L/min
2 P
PEAK
: 20 cmH
2
O
After one breath, the ventilator annunciates a HIGH CIRCUIT PRESSURE ( 1 P
PEAK
) alarm. If the alarm does not sound, check the patient circuit for leaks.
SEVERE OCCLUSION alarm test
1.
Make the following alarm settings change:
2.
2 P
PEAK
: 50 cmH
2
O
Press the alarm reset key to reset all alarms.
3.
Adjust D
SENS
to the V
MAX
setting.
4.
Disconnect the ventilator breathing circuit from the FROM PATIENT port and block the gas flow.
6-10 Operator’s Manual
Alarms
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 ten 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:
2.
2 P
PEAK
: 70 cmH
2
O
Mode : SPONT
Spontaneous type : PS
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
TE
) displayed in the patient data area must be greater than half the delivered volume shown on the volume-time plot in the graphics display in order for apnea to autoreset.
Reference Apnea Ventilation , p. 10-33 for a technical description of apnea ventilation.
LOW EXHALED SPONTANEOUS TIDAL VOLUME alarm test
1.
Make the following patient and alarm settings changes
2.
Trigger type : P
TRIG
2 P
SENS
: 4 cmH
2
O
4 V
TE SPONT
: 2500 mL
Press the alarm reset key to reset the apnea alarm.
Operator’s Manual 6-11
Performance
3.
Slowly squeeze the test lung to simulate spontaneous breaths. The ventilator annunciates a LOW
EXHALED SPONTANEOUS TIDAL VOLUME ( 3 V
TE SPONT
) alarm at the start of the fourth consecutive spontaneous inspiration.
4.
Make the following patient settings changes:
5.
Mode : A/C
4 V
TE SPONT
: OFF
Press the alarm reset key to reset the 4 V
TE SPONT
alarm.
NO O
2
SUPPLY alarm test
1.
Disconnect the oxygen inlet supply. The ventilator annunciates a NO O
2
SUPPLY alarm within one breath.
2.
Connect the oxygen inlet supply. The NO O
2
SUPPLY alarm autoresets within two breaths after oxygen is reconnected.
LOW DELIVERED O
2
% and HIGH DELIVERED O
2
% alarms tests
1.
Make the following patient and alarm settings changes:
2.
P
SENS
: 2 cmH
2
O
O
2
% : 100%
Make the following apnea settings changes:
3.
T
A
: 60 s
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
2
% display should decrease, and the ventilator should annunciate a medium priority 3 O
2
% alarm within 60 s and a high priority 3 O
2
% alarm within two (2) minutes.
6.
Set the O
2
% to 21%.
7.
Observe the GUI screen. The delivered O
2
% display should increase, and the ventilator should annunciate a a medium priority 1 O
2
% alarm within 60 s and a high priority 1 O
2
% alarm within two (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.
6-12 Operator’s Manual
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
sage. 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 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
Determination of an Alarm Condition
The delay time from the moment the alarm condition first occurs until the alarm is annunciated is imperceptible.
Delay to/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 three (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.
Operator’s Manual 6-13
Performance
• 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 the table below) 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.
The table below lists alarm priority levels and their visual, audible, and autoreset characteristics.
An alarm autoresets when the condition causing the alarm no longer exists.
Priority Level
Immediate
High: Immediate attention required to ensure patient safety.
Medium: Prompt attention necessary.
Table 6-2. Alarm Prioritization
Visual indicator
Specific to alarm condition 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.
Flashing yellow 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.
Audible indicator Autoreset characteristics
N/A 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).
Medium-priority audible alarm (a repeating sequence of three tones).
Visual alarm does not auto reset. Visual alarm indicators remain steadily illuminated following an autoreset.
The alarm reset key must be pressed to extinguish visual indicator.
LED indicator turns off and autoreset is entered into the alarm log.
Low: A change in the patient-ventilator system has occurred.
Steadily illuminated yellow 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, nonrepeating).
LED indicator turns off and autoreset is entered into the alarm log.
6-14 Operator’s Manual
Alarms
Priority Level
Normal: Normal ventilator operation
Immediate
Table 6-2. Alarm Prioritization (Continued)
Visual indicator Audible indicator
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.
The secondary alarm annunciates a repeating sequence of single tones, since the primary alarm (part of the GUI) has failed.
Autoreset characteristics
None
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
Category
1
6
7
8
4
5
2
3
Name
Vent-Inop
Exh BUV
Insp BUV
Mix BUV
SVO
Caution
Warning
Notification
Table 6-3. Technical Alarm Categories
Priority
High
High
High
High
High
High
Medium
Low
System Response
Ventilator goes to safe state. Reference
Protection Strategies , p. 4-30.
Backup ventilation
Backup ventilation
Backup ventilation
Ventilator goes to safe state. Reference Ventilator
Protection Strategies , p. 4-30.
Ventilation continues as set
Ventilation continues as set
Ventilation continues as set (not displayed on alarm banner)
Reference the table below for a list of ventilator technical alarms, their meaning, and what to do if they occur.
Reference Alarm Settings Range and Resolution , p. 11-16 for the settings, ranges, resolutions, new
patient default values, and accuracies of all the ventilator alarms.
Operator’s Manual 6-15
Performance
Alarm message
O
2
SENSOR
DEVICE ALERT
Table 6-4. Technical Alarms
Meaning
O
2
sensor is out of calibration or has failed.
Various. Technical alarm category is described.
Reference Technical Alarm Categories , p. 6-15. More information
for the particular technical alarm can be found in the System diagnostic log, a link to which is provided on the expanded alarm banner.
What to do
Re-calibrate or replace O
2
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.
Base message
AC POWER
LOSS
AC POWER
LOSS
APNEA (patient data alarm)
Priority
Low
Low
Table 6-5. Non-technical Alarm Summary
Analysis message
Operating on vent main battery.
Operating on vent main and compressor battery.
Medium Apnea ventilation. Breath
High interval > apnea interval.
Extended apnea duration or multiple apnea events.
N/A
Remedy message
Comments
N/A
Check patient & settings.
Ventilator automatically switches to battery power.
Power switch ON. AC power not available.
Battery operating indicator on status display turns on.
Resets when AC power is restored.
The set apnea interval has elapsed without the ventilator, patient, or operator triggering a breath. Resets after patient initiates a third consecutive breath. Possible dependent alarm:
3V
E TOT
6-16 Operator’s Manual
Operator’s Manual
Base message
CIRCUIT
DISCONNECT
COMPLIANCE
LIMITED V
T
(alarm is not adjustable)
(patient data alarm)
COMPRESSOR
INOPERATIVE
1 P
PEAK
(patient data alarm)
Table 6-5. Non-technical Alarm Summary (Continued)
Priority
High
High
Low
Low
Low
Analysis message
No ventilation.
No ventilation.
Compliance compensation limit reached.
No compressor air.
Last breath ≥ set limit.
Medium Last 3 breaths ≥ set limit.
High Last 4 or more breaths ≥ set limit.
Remedy message
Check patient
Reconnect circuit.
Check patient.
Reconnect circuit.
Check patient and circuit type.
Inspired volume may be
< set. Check patient and circuit type.
Replace compressor
Check patient, circuit & ET tube.
Comments
Ventilator has recovered from unintended power loss lasting more than five minutes, detects circuit disconnect. The GUI screen displays elapsed time without ventilator support.
Resets when ventilator senses reconnect ion.
Ventilator detects circuit disconnect and switches to
Stand-by state; the
GUI screen displays elapsed time without ventilator support.
Resets when ventilator senses reconnection.
Compliance volume required to compensate delivery of a VC,
VC+ or VS breath exceeds the maximum allowed for 3 consecutive breaths.
No compressor ready indicator on status display.
Measured airway pressure ≥ set limit.
Ventilator truncates current breath unless already in exhalation.
Possible dependent alarms: 3 V
TE MAND
,
3 V
E TOT
, 1 f
TOT
. Corrective action: Check patient. Check for leaks, tube type/ID setting. Consider reducing % Supp setting or increasing
2 P
PEAK
.
Alarms
6-17
Performance
Table 6-5. Non-technical Alarm Summary (Continued)
Base message Priority Analysis message
Remedy message
Comments
1 P data alarm)
3 P
COMP
PEAK
(patient
(patient data alarm)
Low Last spont breath ≥ set P
PEAK limit - 5 cmH
2
O.
Medium Last 3 spont breaths ≥ set
P
PEAK
limit - 5 cmH
2
O.
High Last 4 or more spont breaths ≥ set P
PEAK
limit- 5 cmH
2
O.
Low Last 2 breaths, pressure ≤ set limit.
Medium Last 4 breaths, pressure ≤ set limit.
High Last10 or more breaths, pressure ≤ set limit.
•
•
In TC:
Check for leaks, tube type/ID setting.
In PAV+:
Check for leaks, tube type/ID setting.
Pressure of spontaneous breaths ≥ set limit. Possible dependent alarms: 3 V
TE
SPONT
,
3 V
E TOT
, 1
3 V
TE SPONT f
TOT
,
Corrective action:
Check for leaks.
Check for the correct tube type.
Check that the tube inside diameter corresponds to the patient PBW.
Check the 2 P
PEAK setting.
Check for leaks.
Peak inspiratory pressure ≤ alarm setting.
(Available only when
Mandatory Type is
VC+* or when Vent
Type is NIV. Target pressure = the low limit: PEEP + 3 cmH
2
O. Ventilator cannot deliver target volume. Possible dependent alarms:
1 f
TOT
.
Corrective action:
Check patient and settings.
* Because the VC+ pressure control algorithm does not allow the target inspiratory pressure to fall below
PEEP + 3 cmH
2
O, attempting to set the 4 P
PEAK
alarm limit at or below this level will turn the alarm off.
1 O
2
% (patient data alarm)
Medium Measured O
High but < 2 min.
Measured O min.
2
2
% > set for ≥ 30
% > set for ≥ 2
s Check patient, gas sources, O
2 analyzer & ventilator.
The O
2
% measured during any phase of a breath cycle is 7%
(12% during the first hour of operation) or more above the O
2
% setting for at least 30 seconds. (These percentages increase by
5% for four minutes following a decrease in the O
2
% setting.)
6-18 Operator’s Manual
Operator’s Manual
Base message
3 O
2
% (patient data alarm)
1 V data alarm
1V
E TOT
(patient data alarm)
1 f
TE
TOT
(patient
(patient data alarm)
Table 6-5. Non-technical Alarm Summary (Continued)
Priority
High
Low
Medium
High
Low
Last 2 breaths ≥ set limit.
Last 4 breath s≥ set limit.
Last 10 or more breaths ≥ set limit.
Medium V
E TOT
≥ set limit for > 30 s .
High
Low
Analysis message
Measured O
2
% < set O
2
%.
V
E TOT
≥ set limit for ≤ 30 s .
V
E TOT
≥ set limit for > 120 s.
f
TOT
≥ set limit for ≤ 30 s .
Medium f
TOT
≥ set limit for > 30 s .
High f
TOT
≥ set limit for > 120 s .
Remedy message
Check patient, gas sources, O
2 analyzer & ventilator.
Check settings, changes in patient's R&C.
Check patient and settings.
Check patient & settings.
Comments
The O
2
% measured during any phase of a breath cycle is 7%
(12% during the first hour of operation) or more below the O
2
% setting for at least 30 seconds, or below
18%. (These percentages increase by 5% for four minutes following an increase in the O
2
% setting.)
Exhaled tidal volume
≥ set limit. Alarm updated whenever exhaled tidal volume is recalculated. Possible dependent alarm:
1V
E TOT
Expiratory minute volume ≥ set limit.
Alarm updated whenever an exhaled minute volume is recalculated. Possible dependent alarm:
1 V
TE
.
Total respiratory rate
≥ set limit. Alarm updated at the beginning of each inspiration. Reset when measured respiratory rate falls below the alarm limit. Possible dependent alarms: 3 V
TE
MAND
,
3 V
TE SPONT
, 3V
E TOT
Alarms
6-19
Performance
Base message
1 P
VENT
(patient data alarm)
INOPERATIVE
BATTERY
INOPERATIVE
BATTERY
INOPERATIVE
BATTERY
Table 6-5. Non-technical Alarm Summary (Continued)
Priority Analysis message
Low 1 breath ≥ limit.
Medium 2 breaths ≥ limit.
High 3 or more breaths ≥ limit.
Low
Low
Low
Inadequate charge or nonfunctional vent main battery.
Inadequate charge or nonfunctional compressor battery.
Inadequate charge or nonfunctional vent main battery and compressor battery.
Remedy message
Check patient, circuit & ET tube.
Service/replace vent main battery.
Service/replace compressor battery.
Service/replace vent main battery and compressor battery.
Comments
Inspiratory pressure
> 110 cmH
2
O and mandatory type is VC or spontaneous type is TC or PAV+. Ventilator truncates current breath unless already in exhalation.
Possible dependent alarms: 3 V
TE MAND
,
3V
E TOT
1 f
TOT
.
Corrective action:
1.
Check patient for agitation.
Agitated breathing, combined with high
% Supp setting in PAV+ can cause overassistance. Consider reducing
% Supp setting.
2.
Provide alternate ventilation.
Remove ventilator from use and contact Service.
Battery installed but not functioning or charging for ≥ 6 hours. Resets when battery is functional.
6-20 Operator’s Manual
Operator’s Manual
Base message
INSPIRATION
TOO LONG
(patient data alarm)
PAV STARTUP
TOO LONG
(patient data alarm) (occurs only if PAV+ is in use)
PAV R & C NOT
ASSESSED
(patient data alarm) (occurs only if PAV+ is in use)
Table 6-5. Non-technical Alarm Summary (Continued)
Priority Analysis message
Low Last 2 spont breaths = PBW based T
I
limit.
Medium Last 4 spont breaths = PBW based T
I
limit.
High Last 10 or more spont breaths
= PBW based T
I
limit.
Low
Medium PAV startup not complete for
≥ 90 s .
High
Low
PAV startup not complete for
≥ 45 s .
PAV startup not complete for
≥ 120 s .
R and/or C over 15 minutes old.
Medium R and/or C over 30 minutes old.
for
Remedy message
Check patient.
Check for leaks.
Check for leaks, shallow breathing, & settings
1 V
TI
and 1 P
PEAK
.
Check for leaks, shallow breathing, & settings for tube ID, 1 V
TI and 1 P
PEAK
.
Comments
Inspiratory time for spontaneous breath
≥ PBW-based limit.
Ventilator transitions to exhalation. Resets when T
I
falls below
PBW-based limit.
Active only when
Vent Type is INVA-
SIVE.
Unable to assess patient’s resistance and compliance during PAV startup.
Possible dependent alarms 3 V
TE SPONT
,
3V
E TOT
, 1 f
TOT
. Corrective action: Check patient. (Patient’s inspiratory times may be too short to evaluate resistance and compliance.) Check that selected humidification type and empty humidifier volume are correct.
Unable to assess resistance and/or compliance during
PAV+ steady-state.
Startup was successful, but later assessments were unsuccessful. Corrective action: Check patient. (Patient’s inspiratory times may be too short to evaluate resistance and compliance.) Check that selected humidification type and empty humidifier volume are correct.
Alarms
6-21
Performance
Base message
LOSS OF
POWER
Table 6-5. Non-technical Alarm Summary (Continued)
Priority Analysis message
Immediate
N/A N/A
Remedy message
LOW BATTERY
LOW BATTERY
LOW BATTERY
LOW BATTERY
LOW BATTERY
LOW BATTERY
Comments
The ventilator power switch is ON and there is insufficient power from AC and the battery. There may not be a visual indicator for this alarm, but an independent audio alarm sounds for at least
120 seconds. Alarm annunciation can be reset by turning power switch to OFF position.
Resets when battery has ≥ ten minutes of operational time remaining.
Medium Vent main battery operational time < ten minutes.
Medium
Medium
High
High
High
Compressor battery operational time < ten minutes.
Vent main battery operational time < ten minutes and compressor battery operational time < 10 minutes.
Replace or allow recharge vent main battery.
Replace or allow recharge compressor battery.
Replace or allow recharge vent main battery and compressor battery.
Vent main battery operational time < five minutes.
Replace or allow recharge vent main battery.
Compressor battery operational time < five minutes.
Vent main battery operational time < five minutes and compressor battery operational time < 5 minutes.
Replace or allow recharge compressor battery.
Replace or allow recharge vent main battery and compressor battery.
Resets when main battery or compressor battery has ≥ ten minutes of operational time remaining or when AC power is restored.
Resets when battery has ≥ five minutes of operational time remaining or when
AC power is restored.
Resets when battery has ≥ five minutes of operational time remaining or when
AC power is restored.
6-22 Operator’s Manual
Operator’s Manual
3
Base message
V
TE MAND
3 V
TE SPONT
(patient data alarm)
(patient data alarm)
1 V
TI
(patient data alarm)
3V
E TOT
(patient data alarm)
Table 6-5. Non-technical Alarm Summary (Continued)
Priority Analysis message
Low Last 2 mand breaths ≤ set limit.
Medium Last 4 mand breaths ≤ set limit.
High Last 10 or more mand breaths
≤ set limit.
Low Last spont breath ≥ set limit.
Medium Last 3 spont breaths ≥ set limit.
High Last 4 or more spont breaths ≥ set limit.
Remedy message
Check for leaks, changes in patient's R & C.
Low Last 4 spont breaths ≤ set. limit Check patient & settings.
Medium Last 7 spont breaths ≤ set limit.
High Last 10 or more spont breaths
≤ set limit.
In TC, VS, or
PAV+:
Check patient and settings.
Comments
Exhaled mandatory tidal volume.≤ set limit. Alarm updated whenever exhaled mandatory tidal volume is recalculated. Possible dependent alarms: 3V
E TOT
,
1 f
TOT
.
Exhaled spontaneous tidal volume ≤ set limit. Alarm updated whenever exhaled spontaneous tidal volume is recalculated. Possible dependent alarms:
3V
E TOT
1 f
TOT
.
Delivered inspiratory volume ≥ inspiratory limit. Ventilator transitions to exhalation.
Possible dependent alarms: 3 V
TE
SPONT
, 3V
E TOT
, 1 f
TOT
Low
High
V
E TOT
≤ set limit for ≤ 30 s.
Medium V
E TOT
≤ set limit for > 30 s.
V
E TOT
≤ set limit for > 120 s.
Check patient & settings.
Corrective action:
Check for leaks.
Check for the correct tube type.
Check the V
TI
or V
TI setting. In PAV+, check for patient agitation, which can cause miscalculation of R
PAV
and C
PAV
.
Consider reducing %
Supp setting. Check
2 V
TI
.
Total minute volume
≤ set limit. Alarm updated whenever exhaled minute volume is recalculated. Possible dependent alarms 3 V
TE
MAND
, 3 V
TE SPONT
,
1 f
TOT
Alarms
6-23
Performance
Base message
VOLUME NOT
DELIVERED (not adjustable)
(patient data alarm)
NO AIR SUPPLY
NO AIR SUPPLY
NO O
2
PROCEDURE
ERROR
SEVERE
SUPPLY
OCCLUSION
Table 6-5. Non-technical Alarm Summary (Continued)
Priority
Low
Medium Last 10 or more spont (or mand) breaths, pressure > max allowable level.
Low
High
Low
High
High
High
Analysis message
Last 2 spont (or mand) breaths pressure > max allowable level.
Remedy message
Check patient and setting for
1 P
PEAK
Comments
Compressor inoperative. Ventilation continues as set. Only
O
2
available.
Compressor inoperative. Ventilation continues as set, except y O
2
% = 100.
Ventilation continues as set.
Only air available.
Check air source.
Check patient air source.
Ventilation continues as set, except O
2
% = 21.
Patient connected before setup complete.
Little/no ventilation.
Check O source.
2
Check patient &
O
2
source.
Provide alternate ventilation.
Complete setup process.
Check patient.
Provide alternate ventilation.
Clear occlusions; drain circuit.
Operator-set O
2
% equals 21%. Resets if
O
2
supply connected.
Ventilator delivers
21% O
2
instead of set
O
2
%. Resets if oxygen supply connected.
Ventilator begins safety ventilation.
Resets when ventilator startup procedure is complete.
Ventilator enters occlusion status cycling (OSC). Patient data displays are blanked and GUI screen displays elapsed time without ventilator support.
Insp target pressure
> (P
PEAK
-
PEEP - 3 cmH
2
O), when spontaneous type is VS or mandatory type is VC+ Ventilator cannot deliver target volume. Possible dependent alarms: For VC+ breaths: 3 V
TE MAND
,
3V
E TOT
, 1 f
TOT
. For VS breaths: 3 V
TE SPONT
,
3V
E TOT
, 1 f
TOT
Corrective action:
Check patient and settings.
Ventilator delivers
100% O
2
. Air supply pressure ≤
17 psig. Resets if air supply pressure ≥ 35 psig is connected.
6-24 Operator’s Manual
Operator’s Manual
Base message
INADVERTENT
POWER OFF
PROX INOPERA-
TIVE
Table 6-5. Non-technical Alarm Summary (Continued)
Priority
High
Low
Analysis message
Ventilator switched OFF with patient connected to breathing circuit.
Data from proximal flow sensor is not being used.
Remedy message
Return power switch to ON position and disconnect patient before turning power off.
Check proximal flow sensor connections 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 waveforms and monitored volumes are obtained from internal sensors.
Table 6-6. Non-Technical Alarms and Suggested Responses
Alarm message
AC POWER LOSS
Meaning
The ventilator/and or compressor is running on battery power.
APNEA (patient data alarm) The time between patient breaths exceeds the set apnea interval.
CIRCUIT DISCONNECT The patient circuit has become disconnected or there is a large leak in the patient circuit.
Compliance limitedV
(patient data alarm)
T
Compliance volume required to compensate delivery of a VC, VC+, or VS breath exceeds the maximum allowed for three consecutive breaths.
COMPRESSOR INOPERATIVE Air pressure not detected in the compressor’s accumulator. Status display indicates the compressor is inoperative
1 P
PEAK
(patient data alarm) The measured airway pressure is ≥ set limit. Reduced tidal volume likely.
What to do
Monitor the battery charge level to ensure there is enough power remaining to operate the ventilator/compressor.
Check patient and settings.
Re-connect the patient circuit, or eliminate the leak.
Check patient and circuit type.
Inspired volume may be less than set.
Service or replace compressor.
3 P
PEAK
(patient data alarm) The peak inspiratory pressure in the patient circuit ≤ alarm setting.This alarm is only available when NIV is the selected Vent Type or when VC+ is the selected Mandatory type during INVA-
SIVE ventilation.*
•
Check the patient.
•
Check the patient circuit.
•
Check the endotracheal tube.
Check for leaks in the patient circuit and VBS.
Alarms
6-25
Performance
Table 6-6. 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
2
O, attempting to set the 4 P
PEAK
alarm setting at or below this level will turn the alarm off.
1 O
2
% (patient data alarm) The O
2
% measured during any phase of a breath cycle is 7% (12% during the first hour of operation) or more above the O
2
% parameter for at least 30 seconds.The percentage window increases by 5% for four minutes after increasing the set O
2
% value.
Check the patient, the air and oxygen supplies, the oxygen analyzer, and the ventilator.
3 O
2
% (patient data alarm) • The O
2
% measured during any phase of a breath cycle is 7% (12% during the first hour of operation) or more below the O
2
% parameter for at least 30 seconds. The percentage window increases by 5% for four minutes after increasing the set O
2
% value.
•
Check the patient, the air and oxygen supplies, the oxygen analyzer, and the ventilator.
regarding calibrating the oxygen sensor.
Reference Oxygen Sensor Calibration , p. 4-30 for details
1 V
TE
(patient data alarm) Exhaled tidal volume ≥ alarm setting for the last two breaths.
•
• Use an external O
2
monitor and disable the O
2
sensor.
Check patient settings.
• Check for changes in patient’s resistance and compliance.
Check patient settings.
1V
E TOT
(patient data alarm) Minute volume ≥ alarm setting.
1 f
TOT
(patient data alarm) The breath rate from all breaths is ≥ alarm setting.
1
P
VENT
(patient data alarm) The inspiratory pressure transducer has measured a pressure > 110 cmH
2
O in
VC, TC, or PAV+. The ventilator transitions to exhalation. 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/or volume settings.
•
•
• Re-run SST.
Obtain an alternate ventilation source.
Remove the ventilator from clinical use and obtain service.
6-26 Operator’s Manual
Operator’s Manual
Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)
Alarm message
INOPERATIVE BATTERY
INSPIRATION TOO LONG
(patient data alarm)
LOSS OF POWER
LOW BATTERY
3 V
TE MAND alarm)
3 V
TE SPONT alarm)
3V
E TOT
(patient data
(patient data
(patient data alarm)
Meaning
The battery charge is inadequate after
6 hours of attempted charge time 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 Vent Type is INVASIVE.
•
•
•
•
What to do
Recharge the battery by plugging the ventilator into AC power or replace the battery or install an extended battery.
Check the patient.
Check the patient circuit for leaks.
Check Rise time % and
E
SENS
settings.
Check the integrity of the AC power and battery connections.
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.
•
•
Obtain alternative ventilation if necessary.
Install an extended battery.
Medium priority alarm indicating < ten
(10) minutes of battery power remaining to operate the ventilator or compressor.
High priority alarm indicating < five (5) minutes of battery power remain to operate the ventilator or compressor.
The patient’s exhaled mandatory tidal volume is ≤ alarm setting for the last two mandatory breaths.
•
•
• Turn the power switch OFF to reset 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.
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 for changes in the patient’s resistance or compliance.
Check the patient.
Check the ventilator settings.
Check the patient.
Check the ventilator settings.
Alarms
6-27
Performance
NO O
1 P
2
SUPPLY
COMP
Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)
Alarm message
NO AIR SUPPLY
Meaning
The air supply pressure is less than the minimum pressure required for correct ventilator operation. The ventilator delivers 100% O
2
if available. If an oxygen supply is not available, the safety valve opens. The ventilator displays the elapsed time without ventilator support. This alarm cannot be set or disabled.
The oxygen supply pressure is less than the minimum pressure required for correct ventilator operation. 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.
Target pressure ≥ ( 2 P
PEAK
- 5 cmH
2
O
)
•
•
•
•
•
•
Check the air and oxygen sources.
Obtain alternative ventilation if necessary.
Check the patient.
Check the air and oxygen sources.
Obtain alternative ventilation if necessary.
In TC:
What to do
Check the patient.
• Check for leaks and tube type/ID setting.
PROCEDURE ERROR
SEVERE OCCLUSION
The patient is attached before ventilator startup is complete. Safety ventilation is active.
The patient circuit is severely occluded.
The ventilator enters occlusion status cycling. The elapsed time without ventilatory support appears.
•
•
•
•
•
•
•
In PAV+:
Limit target pressure to
2 P
PEAK
- 5 cmH
2
O.
Provide alternate ventilation if necessary.
Complete ventilator startup procedure.
Check the patient.
Obtain alternative ventilation if necessary.
Check patient circuit for bulk liquid, crimps, blocked filter.
If problem persists, remove ventilator from use and obtain service.
6-28 Operator’s Manual
Alarms
Table 6-6. Non-Technical Alarms and Suggested Responses (Continued)
1 V
TI
Alarm message
(patient data alarm)
VOLUME NOT DELIVERED
(patient data alarm
PAV STARTUP TOO LONG
(occurs only if PAV+ option is in use)
PAV R & C NOT ASSESSED
(occurs only if PAV+ option is in use)
PROX INOPERATIVE
Meaning
Delivered inspiratory volume ≥ high inspiratory volume limit.
What to do
•
Ventilator transitions to exhalation.
Check for leaks and tube type/ID setting.
• Check patient and ventilator settings.
•
Check for leaks, tube type/ID and% Supp settings, and patient agitation.
Check patient and 1 P
PEAK
setting.
Insp target pressure >
(P
PEAK
- PEEP - 3 cmH
2
O), when spontaneous type is VS or when mandatory type is VC+.
Unable to assess resistance and/or compliance during PAV+ startup.
Unable to assess resistance and/or compliance during PAV+ steady-state.
A malfunction occurred with the Proximal Flow Sensor or the pneumatic lines are occluded.
Check for leaks, shallow breathing, and settings for
1 V
TI
and 1 P
PEAK
Check for leaks, shallow breathing, and settings for tube ID, 1 V
TI and 1 P
PEAK
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 ten minutes of battery power remaining. The ventilator annunciates a high-priority LOW BATTERY alarm when less than five 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 for the compressor as in normal operation, but the compressor supplies air, providing the charge level of its batteries is sufficient.
Operator’s Manual 6-29
Performance
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
A
). T
A
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
A
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
(this avoids returning to normal ventilation if there is a disconnect).
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
SENS
setting may be used in the circuit disconnect detection algorithms.
Reference Disconnect , p. 10-38 for a complete discussion of the CIRCUIT DISCONNECT
detection methods.
The CIRCUIT DISCONNECT alarm sensitivity is adjusted via the D
SENS
setting. During a CIRCUIT DIS-
CONNECT 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
2
control. Reference To adjust the amount of elevated O2 delivered for two minutes , p. 3-34.
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.
6-30 Operator’s Manual
Alarms
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. Reference Background Diagnostic System , p. 10-61.
6.5.14
HIGH CIRCUIT PRESSURE Alarm
•
•
The 1 P
PEAK
alarm indicates the currently measured airway pressure is equal to or greater than the set limit. The 2 P
PEAK
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 1 P
PEAK
limit is active in all normal ventilation modes.The 2 P
PEAK
alarm new patient default values are separately configurable for neonatal, pediatric, and adult patients. The 2 P
PEAK limit is not active during a SEVERE OCCLUSION alarm.
•
The 1 P
PEAK
alarm truncates inspiration and transitions the ventilator into the exhalation phase and the limit cannot be set less than
PEEP + 7 cmH
2
O or
PEEP + P
I
+ 2 cmH
2
O, or
PEEP + P
SUPP
+ 2 cmH
2
O, nor can it be set less than or equal to 4 P
PEAK
.
The 2 P
PEAK
limit cannot be disabled. The ventilator phases in changes to the 2 P
PEAK
limit immediately to allow prompt notification of a high circuit pressure condition.
The minimum 2 P
PEAK
limit (7 cmH
2
O) corresponds to the lowest peak pressures not due to autotriggering anticipated during a mandatory breath. The maximum 2 P
PEAK
limit (100 cmH
2
O) was selected because it is the maximum pressure required to inflate very low-compliance lungs.
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 2 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
2
% Alarm
The 1 O
2
% alarm indicates the measured O
2
% is at or above the error percentage above the O
2
% setting for at least 30 seconds to eliminate transient O
2
% delivery variation nuisance alarms. The
1 O
2
% alarm detects malfunctions in ventilator gas delivery or oxygen monitor. The ventilator
Operator’s Manual 6-31
Performance declares a 1 O
2
% alarm after 30 seconds. Although the ventilator automatically sets the 1 O
2
% 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 four minutes following a decrease in the setting.)
The ventilator automatically adjusts the 1 O
2
% alarm limit when O
2
% changes due to 100% O
2
, apnea ventilation, occlusion, circuit disconnect, or a NO AIR/O
2
SUPPLY alarm. The ventilator checks the 1 O
2
% alarm limit against the measured oxygen percentage at one-second intervals.
6.5.16
HIGH EXHALED MINUTE VOLUME Alarm
The 1V
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 1V
E TOT
alarm is effective immediately upon changing the setting, to ensure prompt notification of prolonged high tidal volumes.
The 1V
E TOT
alarm can be used to detect a change in a patient's breathing pattern, or a change in compliance or resistance. The 1V
E TOT
alarm can also detect too-large tidal volumes, which could lead to hyperventilation and hypocarbia.
6.5.17
HIGH EXHALED TIDAL VOLUME Alarm
The 1 V
TE
alarm indicates the measured exhaled tidal volume for spontaneous and mandatory breaths is equal to or greater than the set 1 V
TE
alarm. The 1 V
TE
alarm is updated whenever a new measured value is available.
The 1 V
TE
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 1 V
TE
alarm OFF to 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.)
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 Vent
Type is NIV, there is no high inspired tidal volume alarm or setting available, but the monitored inspired tidal volume (V
TI
) may appear in the patient data area on the GUI screen.
6-32 Operator’s Manual
Alarms
6.5.19
HIGH RESPIRATORY RATE Alarm
The 1 f
TOT
alarm indicates the measured breath rate is greater than or equal to the 2 f
TOT
alarm setting. The 1 f
TOT
alarm is updated whenever a new total measured respiratory rate is available.
The 1 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 2 f
TOT
limit immediately to ensure prompt notification of a high respiratory rate condition.
6.5.20
INSPIRATION TOO LONG Alarm
The INSPIRATION TOO LONG alarm, active only when Vent Type is INVASIVE, indicates the inspiratory time of a spontaneous breath exceeds the following time limit:
(1.99 + 0.02 x PBW) seconds (adult and pediatric circuits)
(1.00 + 0.10 x 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
2
O, attempting to set the 4 P
PEAK
alarm limit at or below this level will turn the alarm off.
The 3 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 3 P
PEAK
alarm is active for mandatory and spontaneous breaths, and is present only when Vent
Type is NIV or Mandatory Type is VC+. During VC+, the 3 P
PEAK
alarm can be turned OFF. The 3 P
PEAK alarm can always be turned OFF during NIV. The 4 P
PEAK
alarm limit cannot be set to a value greater than or equal to the 2 P
PEAK
alarm limit.
Operator’s Manual 6-33
Performance
In VC+, whenever PEEP is changed, 3 P
PEAK
is set automatically to its New Patient value, PEEP + 4 cmH
2
O when PEEP ≥ 16 cmH
2
O, or PEEP + 3.5 cmH
2
O when PEEP < 16 cmH
2
O.
There are no alarms dependent upon 3 P
PEAK
, and the 3 P
PEAK
alarm does not depend on other alarms.
6.5.22
LOW DELIVERED O
2
% Alarm
The 3 O
2
% alarm indicates the measured O
2
% during any phase of a breath is at or below the error percentage below the O
2
% setting, or less than or equal to 18%, for at least 30 seconds. Although the ventilator automatically sets the 3 O
2
% alarm, replace (if necessary) or disable the oxygen sensor to avoid nuisance alarms. The error 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 four minutes following an increase in the setting.
The ventilator automatically adjusts the 3 O
2
% alarm limit when O
2
% changes due to apnea ventilation, circuit disconnect, or a NO O
2
/AIR SUPPLY alarm. The 3 O
2
% alarm is disabled during a safety valve open (SVO) condition. The ventilator checks the 3 O
2
% alarm against the measured oxygen percentage at one-second intervals.
The 3 O
2
% alarm can detect malfunctions in ventilator gas delivery or the oxygen monitor, and can ensure the patient is adequately oxygenated. The ventilator declares a 3 O
2
% alarm after 30 seconds to eliminate nuisance alarms from transient O
2
% delivery variations. The O
2
% measured
by the oxygen sensor is shown in the patient data area. Reference Vital Patient Data , p. 3-35 to
include O
2
% 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 3 V
TE
MAND
alarm setting. The 3 V
TE MAND
alarm updates when a new measured value of exhaled mandatory tidal volume is available.
The 3 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 3 V
TE MAND
alarm immediately to ensure prompt notification of a low exhaled tidal volume condition.
6-34 Operator’s Manual
Alarms
6.5.24
LOW EXHALED SPONTANEOUS TIDAL VOLUME Alarm
The 3 V
TE SPONT
alarm indicates the measured exhaled spontaneous tidal volume is less than or equal to the 3 V
TE SPONT
alarm setting. The alarm updates when a new measured value of exhaled spontaneous tidal volume is available.
The 3 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 3 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 if this software option is installed. The ventilator phases in a change to the 4 V
TE SPONT
alarm limit immediately to ensure prompt notification of a low exhaled tidal volume condition.
6.5.25
LOW EXHALED TOTAL MINUTE VOLUME Alarm
The 3V
E TOT
alarm indicates the measured minute volume (for mandatory and spontaneous breaths) is less than or equal to the 3V
E TOT
alarm setting. The 3V
E TOT
alarm updates with each new calculation for exhaled minute volume.
The 3V
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 3V
E TOT
alarm can also detect toosmall tidal volumes, which could lead to hypoventilation and hypoxia (oxygen desaturation).
The ventilator phases in changes to the 3V
E TOT
alarm limit immediately to ensure prompt notification of prolonged low tidal volumes.
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 five minutes) and the ventilator detects a patient attached before Ventilator Startup is complete. Until confirmation of the
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
Operator’s Manual 6-35
Performance 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. Reference Areas of the GUI , p. 4-3. Where applicable, factory defaults are indi-
cated.
Reference Vital Patient Data , p. 3-35 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 ( V
E TOT
) is the BTPS and compliance compensated sum of exhaled gas volumes from both mandatory and spontaneous breaths for the previous one-minute interval. A factory default parameter.
6.6.2
Exhaled Spontaneous Minute Volume
Exhaled spontaneous minute volume ( V
E SPONT
) is the BTPS- and compliance-compensated sum of exhaled spontaneous volumes for the previous minute. A factory default parameter.
6-36 Operator’s Manual
Monitored Patient Data
6.6.3
Exhaled Tidal Volume
Exhaled tidal volume (V
TE
) is the volume of the patient’s exhaled gas for the previous mandatory or spontaneous breath. Displayed V
TE
is both compliance-and BTPS compensated, and updates at the next inspiration. A factory default parameter.
6.6.4
Proximal Exhaled Minute Volume
Proximal exhaled minute volume ( V
E TOTY
) is the BTPS- and compliance-compensated sum of exhaled spontaneous volumes for the previous minute.
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 two minutes (for example via a manual inspiration), the V
TE MAND
patient data indicator becomes hidden.The indicator reappears when the value updates. A factory default parameter.
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
TI
) is the BTPS- and compliance-compensated volume of inspired gas for all pressure-based or NIV breaths, updated at the beginning of the following expiratory phase. V
TI is displayed when data are available. A factory default parameter.
Operator’s Manual 6-37
Performance
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
TIY
is updated at the beginning of the following expiratory phase and is displayed when data are available.
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. A factory default parameter.
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
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 or negative. A factory default parameter.
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. A factory default parameter.
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. A factory default parameter.
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. A factory default parameter.
6-38 Operator’s Manual
Monitored Patient Data
6.6.17
Intrinsic PEEP
Intrinsic PEEP (PEEP
I
) is an estimate of the pressure above the PEEP level at the end of an exhalation. PEEP
I
is determined during an Expiratory Pause maneuver.
6.6.18
PAV-based Intrinsic PEEP
PAV-based intrinsic PEEP (PEEP
I PAV
) is an estimate of intrinsic PEEP, updated at the end of a spontaneous PAV+ breath.
6.6.19
Total PEEP
Total PEEP (PEEP
L
) is the estimated pressure at the circuit wye during the Expiratory Pause maneuver.
6.6.20
Plateau Pressure
Plateau pressure (P
PL
) is the pressure measured and displayed during an Inspiratory Pause maneuver.
6.6.21
Total Respiratory Rate
Total respiratory rate (f
TOT
) is the total number of mandatory and spontaneous breaths per minute delivered to the patient. A factory default parameter.
6.6.22
PAV-based Lung Compliance
For a PAV+ breath, PAV-based lung compliance (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 each calculation. C
PAV
is displayed on the waveform screen.
6.6.23
PAV-based Patient Resistance
For a PAV+ breath, PAV-based patient resistance (R
PAV
) is the change in pulmonary pressure for an applied change in patient lung flow and updated upon successful completion of each calculation. R
PAV
is displayed on the waveform screen.
Operator’s Manual 6-39
Performance
6.6.24
PAV-based Lung Elastance
For a PAV+ breath, PAV-based lung elastance (E
PAV
) is the inverse of C
PAV
and is updated upon successful completion of each calculation.
6.6.25
Spontaneous Rapid Shallow Breathing Index
Spontaneous rapid shallow breathing index ( f /V
T
) 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 indicate the inverse. A factory default parameter.
6.6.26
Spontaneous Inspiratory Time Ratio
In SPONT mode, spontaneous inspiratory time ratio (T
I
/T
TOT
) is the percentage of a spontaneous breath consumed by the inspiratory phase. Updated at the successful completion of a spontaneous breath. A factory default parameter.
6.6.27
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. A factory default parameter.
6.6.28
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
PAV
value appears in parentheses as described at the beginning of this section, the R
TOT
value also appears in parentheses.
6.6.29
Static Compliance and Static Resistance
Static compliance (C
STAT
) is an estimate of the elasticity of the patient’s lungs, expressed in mL/ cmH
2
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
2
O/L/s. R
STAT
is computed during a VC mandatory breath with a square flow waveform.
6-40 Operator’s Manual
Monitored Patient Data
C
STAT
is calculated using this equation:
C
STAT
=
P ckt
V
– pt
PEEP
– C ckt
C
STAT
V pt
Static compliance
Total expiratory volume (patient and breathing circuit)
P ckt
PEEP
The pressure in the patient circuit measured at the end of the 100 ms interval defining the pause-mechanics plateau
The pressure in the patient circuit measured at the end of expiration
C ckt
Compliance of the breathing circuit during the pause maneuver (derived from
SST)
R
STAT
is calculated using this equation after C
STAT
is computed and assuming a VC breath type with a SQUARE waveform:
R
STAT
=
1 +
C
---------------
C
STAT
P
PEAK
– P
PL
V pt
R
STAT
Static resistance
C
STAT
Static compliance
C ckt
Compliance of the breathing circuit during the pause maneuver (derived from
SST)
P
PL
Mean pressure in the patient circuit over the 100 ms interval defining the pausemechanics plateau
P
PEAK
Peak circuit pressure
V pt
Flow into the patient during the last 100 ms of the waveform
During the pause, the most recently selected graphics are displayed and frozen, to determine when inspiratory pressure stabilizes. C
STAT
and R
STAT
are displayed at the start of the next inspiration following the inspiratory pause and take this format:
C
STAT xxx or
Operator’s Manual 6-41
Performance
•
•
R
STAT
yyy
•
Special formatting is applied if the software determines variables in the equations or the resulting
C
STAT
or R
STAT
values are out of bounds:
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.
6.6.30
Dynamic Compliance
Dynamic compliance (C
DYN
) is a dynamic estimate of static compliance for each mandatory breath delivered.
6.6.31
Dynamic Resistance
Dynamic resistance (R
DYN
) is a dynamic estimate of static resistance for each mandatory breath delivered.
6.6.32
C
20
/C
C
20
/C is the ratio of compliance of the last 20% of inspiration to the compliance of the entire inspiration.
6.6.33
End Expiratory Flow
End Expiratory Flow (EEF) is a measurement of the end expiratory flow for an applicable breath.
6.6.34
Peak Spontaneous Flow
Peak Spontaneous Flow (PSF) is a measurement of the maximum inspiratory spontaneous flow for an applicable spontaneous breath
6.6.35
Displayed O
2
%
Displayed O
2
% 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
2
% for alarm determination, and not as a measurement of oxygen delivered to the patient.
O
2
% data can be displayed as long as the O
2
monitor is enabled. If the monitor is disabled, dashes
(--) are displayed. If a device alert occurs related to the O
2
monitor, a blinking 0 is displayed.
6-42 Operator’s Manual
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 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. Reference Operator Preventive Maintenance Frequency
Service Preventive Maintenance Frequency , p. 7-19.
7-1
Preventive Maintenance
Table 7-1. Operator Preventive Maintenance Frequency
Part
Patient circuit: inspiratory and expiratory limbs
Condensate vial, water traps, and drain bag
Oxygen sensor calibration
Frequency
Several times a day or as required by the institution's policy.
•
Maintenance
Check both limbs for water accumulation.
• Empty and clean.
Check and empty as needed.
From the ventilator setup screen, touch the More Settings tab. To calibrate the oxygen sensor, touch Calibrate in the oxygen sensor area of the screen.
Reference Oxygen sensor calibration testing , p. 4-30 for information
on testing the oxygen sensor calibration.
Inlet air filter bowl
• Replace bowl if it is cracked.
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
•
•
•
• 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 disposal, or dispose of filter according to the institution’s policy.
Run SST to check resistance of the inspiratory limb.
Use care when changing inspiratory filter to avoid filter damage and minimize the potential for introduction of particles.
7-2 Operator’s Manual
Operator’s Manual
Preventive Maintenance Intervals
Battery
Exhalation flow sensor assembly
(EVQ)
Table 7-1. Operator Preventive Maintenance Frequency (Continued)
Part
Reusable exhalation filter
Disposable inspiratory Filter
Disposable exhalation Filter
Battery
Compressor inlet air filter
Neonatal door/adapter
•
•
•
•
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
•
Maintenance
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 disposal, or dispose of filter according to the institution’s policy.
•
•
Run SST to check resistance of the expiratory limb and exhalation filter.
Use care when changing exhalation filter to avoid filter damage and minimize the potential for introduction of particles.
After 15 days of continuous use
(discard)
After 15 days of continuous use
(discard)
When transferring battery to or from another ventilator
Every three (3) years
Per institutional guidelines, or if
SST flow sensor cross check fails.
DO NOT STERILIZE the exhalation flow sensor assembly.
Every 100 disinfection cycles. A disinfection cycle is defined as one disinfection event as described in
Sensor Assembly (EVQ) Disinfection
Every 250 hours
When gas pathway surfaces are visibly soiled or per institutional guidelines.
When exterior surfaces of door are soiled.
Discard according to the institution’s protocol.
Discard according to the institution’s protocol.
Disinfect by wiping with a damp cloth using one of the solutions
listed. Reference Surface Cleaning
Agents , p. 7-5 for approved clean-
ing agents.
Replace
Disinfect. See Component Cleaning and Disinfection (7.5) , on page
and
Assembly (EVQ) Disinfection (7.5.1) , on page 7-8
.
Replace. Discard used flow sensor according to the institution's protocol. Run exhalation flow sensor calibration and SST.
Wash in mild soapy water and rinse thoroughly. Let air dry.
Surface clean per Surface Cleaning of Exterior Surfaces (7.4)
.
7-3
7-4
Preventive Maintenance
Caution:
Use specified cleaning, disinfection, and sterilization agents and procedures for the appropriate part as instructed. Follow cleaning procedures outlined below.
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, Inc.). Reference the table,
Surface Cleaning Agents . below.
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.
Operator’s Manual
Component Cleaning and Disinfection
Table 7-2. Surface Cleaning Agents
Part
Ventilator exterior (including touch screen and flex arm)
Procedure
Wipe clean with a cloth dampened with one of the cleaning agents listed below or equivalent.
Use a damp cloth and water to rinse off chemical residue as necessary.
Mild dish washing detergent solution
Isopropyl alcohol (70% solution)
Bleach (10% solution)
Window cleaning solution (isopropyl alcohol and ammonia)
Ammonia (15% solution)
Hydrogen peroxide (3% solution)
Formula 409
®
cleaner (Clorox
Company)
CaviCide
®
surface disinfectant
(Metrex Research Corporation
Control III
®
germicide (Maril Products, Inc.)
Mr. Muscle Window & Glass (SC
Johnson
Sani Cloths (PDI, Inc.)
Ventilator cooling vents
[Propan-2-ol, Isopropanol, Isopropyl Alcohol]
1
Vacuum the vents at the back of the GUI and BDU to remove dust.
1.
Chemicals stated are the generic equivalents of Mr. Muscle Window & Glass
Comments/Cautions
Do not allow liquid or sprays to penetrate the ventilator openings or cable connections.
Do not attempt to sterilize the ventilator 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.
Operator’s Manual 7-5
Preventive Maintenance
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.
EVQ
Part
Table 7-3. Component Cleaning Agents and Disinfection Procedures
Neonatal door/adapter
Reusable patient circuit tubing
Cleaning Agent/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:
Cidex (2.5%)
Comments/Cautions
Do not drop the EVQ or handle roughly during disinfection or storage .
• Metricide 28 (2.5%)
Metricide OPA Plus (0.6%) •
Follow the manufacturer’s instructions
Reference Exhalation Flow Sensor
Assembly (EVQ) Disinfection , p. 7-8
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%)
N/A
• Metricide 28 (2.5%)
Metricide OPA Plus (0.6%) •
Follow the manufacturer’s instructions.
Disinfect per manufacturer’s instructions-for-use.
• Inspect for nicks and cuts, and replace if damaged.
Disposable patient circuit tubing Discard
•
Run SST to check for leaks when reinstalling the circuit or when installing a new circuit.
Discard per the institution’s protocol.
7-6 Operator’s Manual
Component Cleaning and Disinfection
Table 7-3. Component Cleaning Agents and Disinfection Procedures (Continued)
Part
Breathing circuit in-line water traps
Cleaning Agent/Procedure
Disinfect per manufacturer’s instructions-for-use.
•
Comments/Cautions
Inspect water traps for cracks and replace if damaged.
Breathing circuit components Disinfect per manufacturer’s instructions-for-use.
•
• Run SST to check for leaks when reinstalling the circuit or when installing new components.
Inspect components for nicks and cuts, and replace if damaged.
Disposable drain bag and tubing
(single unit)
Inlet air filter bowl
• Run SST to check for leaks when reinstalling the circuit or when installing a new components.
Discard when filled to capacity or when changing patient circuit.
Wash the bowl with mild soap solution, if needed.
•
N/A
Avoid exposing the inlet air filter bowl to aromatic solvents, especially ketones.
Battery
Cooling fan filter
Other accessories
Wipe with a damp cloth using one of the cleaning agents listed.
Clean every 250 hours or as necessary. Wash in mild soap solution, rinse, and air dry.
Follow manufacturer’s instructions-for-use.
N/A
N/A
• Replace if cracks or crazing are visible.
Do not immerse the battery or get the contacts wet.
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. Reference Component Cleaning
Agents and Disinfection Procedures , p. 7-6. 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.
Operator’s Manual 7-7
7-8
Preventive Maintenance
Note:
Steps 1 through 3 above do not apply to the EVQ. Reference Exhalation Flow Sensor Assembly (EVQ)
Disinfection , p. 7-8 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
disinfectants.
Note:
Follow the institution’s infection control protocol for handling, storage, and disposal of potentially biocontaminated 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.
Operator’s Manual
Figure 7-1. EVQ
Component Cleaning and Disinfection
1 Top view 2 Bottom view
Figure 7-2. EVQ Components
1
2
Hot film wire and thermistor
Diaphragm sealing surface
3
4
Electrical contacts
Filter grommet
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.
Operator’s Manual 7-9
Preventive Maintenance
2.
With thumb inserted into the plastic exhalation port and four (4) 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.
Figure 7-3. 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 7-4. Exhalation Valve Diaphragm Removal
7-10 Operator’s Manual
Figure 7-5. Exhalation Filter Seal Removal
Component Cleaning and Disinfection
Figure 7-6. 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.
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. Reference Component Cleaning Agents and Disinfection
Procedures , p. 7-6. Using disinfectants not recommended by Covidien may damage the plastic
Operator’s Manual 7-11
Preventive Maintenance 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.
1.
2. The purpose for this pre-soak is to break down any bio-film that may be present. Follow manufac-
turer’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 insti-
tution’s protocol. Reference Component Cleaning Agents and Disinfection Procedures , p. 7-6 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 7-7. Immersion Method
7-12
5.
At the end of the disinfecting immersion period, remove and drain all disinfectant. Ensure all cavities are completely drained.
Operator’s Manual
Component Cleaning and Disinfection
Rinsing
WARNING:
Rinse according to manufacturer’s instructions. Avoid skin contact with disinfecting agents to prevent possible injury.
Rinse the EVQ using clean, de-ionized water in the same manner used for the disinfection step.
1.
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.
Drying
1.
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).
Caution:
Exercise care in placement and handling in a dryer to prevent damage to the assembly’s flow sensor element.
Inspection
Reference EVQ Components , p. 7-9 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:
Operator’s Manual 7-13
Preventive Maintenance
Figure 7-8. EVQ Reprocessing Kit
1
2
Diaphragm
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.
Figure 7-9. 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
Ensure that the seal fits completely within the recess and sits flat.
7-14 Operator’s Manual
Figure 7-10. Installing the Exhalation Filter Seal
Component Cleaning and Disinfection
1 Exhalation filter seal
4.
Remove the diaphragm from the kit and install it. See Figure 7-11.
Operator’s Manual 7-15
Preventive Maintenance
Figure 7-11. 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. Reference Operator Preventive Maintenance Frequency , p. 7-2.
To install the EVQ into the ventilator
1.
With the exhalation filter door open, insert the assembly directly under the exhalation valve and push
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.
7-16 Operator’s Manual
Figure 7-12. Installing the EVQ
Component Sterilization
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. Reference To run SST , p. 3-40.
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.
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.
Operator’s Manual 7-17
Preventive Maintenance
Table 7-4. Sterilization Parameters
Autoclave sterilization
Effective sterilization occurs by steam autoclaving at 132°C (170°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.
6.
7.
8.
4.
5.
2.
3.
Clean the component, then steam autoclave*.
Wrap each component in muslin or equivalent paper for autoclaving.
Place the wrapped parts in the steam autoclave and sterilize.
Inspect the sterilized parts for damage, and discard if damaged.
Reassemble the component.
Install the component on the ventilator.
Run SST.
*If performing pre-vac sterilization, follow system manufacturer’s instructions for use (IFU).
Table 7-5. Component Sterilization Procedures
Part
Reusable exhalation and inspiratory filters
Procedure
Steam autoclave per manufacturer’s instructions-for-use
•
Comments/Cautions
Do not chemically disinfect or expose to ETO gas.
Exhalation filter condensate vial Steam autoclave per manufacturer’s instructions-for-use
•
•
•
•
Check filter resistance using ventilator SST or other means before reuse.
Follow manufacturer’s recommendations for reuse.
Inspect the condensate vial for cracks after processing.
Replace condensate vial if damaged.
Reusable drain bag tubing (short piece of tubing attached to drain bag) and clamp
Clean and autoclave the reusable
tubing; clean the clamp. Reference Surface Cleaning Agents , p. 7-
5 for approved cleaning agents.
N/A
Whenever replacing or reinstalling a component, run SST before ventilating a patient.
7-18 Operator’s Manual
Service Personnel Preventive Maintenance
7.7
Service Personnel Preventive Maintenance
Covidien recommends only qualified service personnel perform preventive maintenance activities summarized in the table below. 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 7-6. Service Preventive Maintenance Frequency
Frequency
Every 6 months
Every 12 months
When ventilator location changes by 1000 feet of altitude
Every 3 years, or when battery test fails, or when EST indicates battery life has been exhausted
Every 10,000 operational hours
Part
Entire ventilator
Primary and extended batteries
Maintenance
Run Extended Self Test (EST).
Perform battery test (as part of
EST and perform stand-alone battery test in Service mode).
Entire ventilator Run performance verification.
This includes running an electrical safety test and inspecting ventilator for mechanical damage and for label illegibility.
Atmospheric pressure transducer Perform atmospheric pressure transducer calibration.
Primary battery Replace primary batteries (ventilator and compressor). Actual battery life depends on the history of use and ambient conditions.
Extended batteries
Internal inspiratory filter
BDU 10K hour kit, p/n 10097275
Replace extended batteries (ventilator and compressor). Actual battery life depends on the history of use and ambient conditions.
Replace. Do not attempt to autoclave or reuse.
Install. Reference the Puritan Bennett™ 980 Series Ventilator Service
Manual for information on tests required after installation of 10K
PM Kit.
Compressor 10K hour kit, p/n
10097258
Install. Reference the Puritan Bennett™ 980 Series Ventilator Service
Manual for information on tests required after installation of 10K
PM Kit.
Operator’s Manual 7-19
Preventive Maintenance
Table 7-6. Service Preventive Maintenance Frequency (Continued)
Frequency
Every year or as needed Oxygen sensor
Part
•
Maintenance
Replace the oxygen sensor as needed.
• Actual sensor life depends on operating environment.
Operation at higher temperature or O2% levels will result in shorter sensor life.
7.8
Safety Checks
Covidien factory-trained service personnel should perform Extended Self Test (EST) on the ventilator after servicing it at the intervals specified in the table above. Reference 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 Covidien factory-trained service personnel at the intervals specified in the table above.
7.10
Documentation
Covidien factory-trained service personnel should manually enter the service date, time, and nature of repair/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.
7-20 Operator’s Manual
Storage for Extended Periods
To return the ventilator to service
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.
Operator’s Manual 7-21
Preventive Maintenance
Page Left Intentionally Blank
7-22 Operator’s Manual
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 infor-
mation, including how to respond to alarms, Reference Chapter 6 to address individual alarms
that may occur during ventilator use. Qualified service personnel who have attended the Covidien 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 Covidien Customer Service at 1.800.255.6774 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 nondestructive disposal.
8-1
Troubleshooting
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 Covidien personnel when the ventilator is in Service mode. The Puritan Bennett™ 980
Series Ventilator Service Manual gives more details regarding logs available to qualified service personnel.
•
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 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 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
2of the additional patient data banner. A total of ten (10) 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:
8-2 Operator’s Manual
Ventilator 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. Reference 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. Reference 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 (reference 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
calibration, patient connection, elevate O
2
, and warning notifications. The General event log can display up to 256 entries and is not cleared upon new patient setup.
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.
Operator’s Manual 8-3
Troubleshooting
Figure 8-1. Log Screen
8-4
1
2
Individual logs tabs
Pages contained in the log being viewed
Ventilator logs can be saved by entering Service mode, and downloading them via the ethernet port. Reference 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 a more information on the diagnostic codes, reference the Puritan Bennett™ 980 Series Ventilator Service Manual or contact Covidien Technical Support.
Operator’s Manual
9 Accessories
9.1
Overview
•
•
•
•
•
This chapter includes accessories that can be used with the Puritan Bennett™ 980 Series Ventilator.
Reference Accessories and Options , p. 9-3 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/ 22mm connection for neonatal, pediatric, and adult patients. Manufacturers include Fisher
& Paykel, DAR, and Hudson RCI/Teleflex
Masks — ResMed, Respironics, Fisher & Paykel
Patient Monitoring Systems —
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
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, in order to minimize risk of phthalate exposure in children and nursing or pregnant women, this product should only be used as directed.
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 Ventilator System.
9-1
Accessories
Figure 9-1. Ventilator with Accessories
Figure 9-2. Additional Accessories
9-2
ing table.
Operator’s Manual
General Accessory Information
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).
, a ventilator breathing circuit assembly that passes SST for a particular patient type
(adult, pediatric, or neonatal) will allow the ventilator to operate within specification for that same patient type. Refer to
Table 11-4. for acceptable compliance and resistance ranges.
Table 9-1. Accessories and Options
Item number
1
2
3
4
5
6
7
8
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
1
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
Operator’s Manual 9-3
Accessories
9-4
Table 9-1. Accessories and Options (Continued)
10
11
12
13
14
15
Item number
9
Accessory or option description
Air hose assembly; Norway, Sweden, Finland, Denmark, Greece,
France
Air hose assembly; Canada
Air hose assembly; Italy, Switzerland, Spain, Belarus, Kazakhstan
Air hose assembly; Japan, Israel
Air hose assembly; Poland, Portugal, South Africa
Air hose assembly; Switzerland
Part number
4-074696-00
4-074709-00
4-074706-00
10001777
4-074703-00
4-074707-00
4-006541-00
4-074714-00
Air hose assembly; United States, Latin America
Air hose assembly; Germany, Luxembourg, Austria, Netherlands,
Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria,
Romania
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, Kazakhstan
Oxygen hose assembly; Japan, Israel
Oxygen hose assembly; Poland, Portugal, South Africa
Oxygen hose assembly; Switzerland
4-074713-00
4-074697-00
4-074710-00
4-074705-00
10001766
4-074705-00
4-074708-00
Oxygen hose assembly; United States, Latin America
Oxygen hose assembly; Germany, Luxembourg, Austria, Netherlands, Belgium, Croatia, Turkey, Russia, Slovenia, Serbia, Bulgaria,
Romania
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.
10086050 Cylinder mount for compressed Air and O
2
gas
Flex arm assembly
Compressor base
4-032006-00
10085981
Rechargeable Lithium Ion battery
Humidifier bracket
Drain Bag Clip
10086042
10086049
10087137
Operator’s Manual
Operator’s Manual
General Accessory Information
Table 9-1. Accessories and Options (Continued)
Item number
16
17
18
19
20
21
22
Not shown
Not shown
Accessory or option description
Inspiratory bacteria filter, reusable (Re/Flex)
Inspiratory bacteria filter, disposable (carton of 12) (DAR)
Condensate vial, reusable
Condensate vial drain cap
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)
2
Ventilator breathing circuit, adult, dual heated, no water traps, disposable (Hudson RCI / Teleflex)
2
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)
2
Ventilator breathing circuit, pediatric, dual heated, disposable
(Hudson RCI / Teleflex
2
Assy, patient circuit, neonatal, single heated wire, disposable, incubator 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
2
Ventilator breathing circuit, neonatal, dual heated system, disposable, Fisher & Paykel - (Fisher & Paykel)
2
O-ring seal, condensate vial, reusable
Neonatal exhalation filtration system, disposable, with condensate vial
Proximal Flow monitoring sensor (disposable, 10/box)
Exhalation valve module reprocessing kit (6/ carton)
Hardware options
Gold standard test circuit, 21 inch (for performing EST)
Part number
4-074600-00
351U5856
10063031
4-074613-00
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
9-5
Accessories
Table 9-1. Accessories and Options (Continued)
Item number
Not shown
Not shown
Accessory or option description
Proximal Flow monitoring option
980, USB flash drive
Software options
Part number
10084331
PT00011076
Not shown
Not shown
NeoMode 2.0 Software
NeoMode 2.0 Software Upgrade
10086743
10096526
1.
Reusable filtration system does not include condensate vial. Reusable condensate vial must be ordered separately.
2.
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.
9-6 Operator’s Manual
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 below.
Section Number
10.1
10.2
10.3
10.4
10.5
10.6
10.14
10.15
10.16
10.17
10.18
10.19
10.7
10.8
10.9
10.10
10.11
10.12
10.13
Title
Reference Theoretical Principles
Reference Applicable Technology
Reference Inspiration — Detection and initiation
Reference Exhalation — Detection and Initiation
Reference Compliance and BTPS Compensation
Reference Mandatory Breath Delivery
Reference Spontaneous Breath Delivery
Reference Spontaneous (SPONT) Mode
Reference Detecting Occlusion and Disconnect
Reference Respiratory Mechanics
Reference Power On Self Test (POST)
Reference Short Self Test (SST)
Reference Extended Self Test (EST)
Page
10-1
Theory of Operations
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 35 psig and 87 psig (241.8 kPa to 599.8 kPa). 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.
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
2
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
2
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 Operator’s Manual
Theoretical Principles
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, noninteractive LCD display located on the Breath Delivery Unit (BDU) is controlled by its own proces-
sor. Reference Status Display , p. 2-25 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. Reference To configure Comm ports , p.
5-4 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/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. Reference the figure below. 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).
Operator’s Manual 10-3
Theory of Operations
10-4
Disturbances
Input
+ Error signal
–
Controller
(software)
Actuator
(hardware)
Manipulated
Variable
Plant
Controlled
Variable
Feedback Signal
Note:
In the diagram above, 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 (
V
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
). Reference the figure below. As the patient begins the inspiratory effort and breathes gas from the circuit (event 5, the A-B interval in the figure, below), pressure decreases below
Operator’s Manual
Inspiration — Detection and initiation
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
. A smaller P
SENS
setting means a shorter A-B time interval. (The minimum P
SENS setting is limited by autotriggering, and the triggering criteria include filtering algorithms that minimize the probability of autotriggering.)
Figure 10-1. Inspiration Using Pressure Sensitivity
1
2
3
Exhalation
Inspiration
Event A: (patient inspires)
4
5
6
Event B: Patient-triggered inspiration begins
A-B interval
Operator-set pressure sensitivity
10.4.2
Flow Triggering
If flow triggering (
V
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 ( V
SENS
). Reference Inspiration Using Flow Sensitivity , p. 10-6 where
the top graphic represents expiratory flow and the bottom graphic represents inspiratory flow.]
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 V
SENS
to a value equal to desired V
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. Reference the figure below (event A). As the patient continues to inspire, the difference between the delivery and exhalation flow sensor mea-
Operator’s Manual 10-5
Theory of Operations surements 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. Reference
Inspiration Using Flow Sensitivity , (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, and
• the flow sensitivity value. The smaller the value, the shorter the delay.
During flow triggering, a backup pressure sensitivity of 2 cmH
2
O is present to detect a breath trigger in the event that the flow trigger fails.
Figure 10-2. Inspiration Using Flow Sensitivity
10-6
1
2
3
4
Software-set base flow (L/min)
Start of patient effort
Event A: flow is decreasing
Event B: Gas delivery begins
5
6
7
Operator-set flow sensitivity
1.5 L/min
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 .
Operator’s Manual
Exhalation — Detection and Initiation
Figure 10-3. Breath Activity During Time-triggered Inspiration
1
2
Breath activity (VIM)
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
of exhalation.
10.5
Exhalation — Detection and Initiation
•
•
•
When exhalation occurs, it is called cycling. Mandatory breaths can be volume-cycled or timecycled by the ventilator or pressure cycled by the patient. Spontaneous breaths can be flowcycled 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 (3) methods described below 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
) target value + an incremental value. This transition to exhalation occurs during spontaneous pressure-based ventilation and in volume support (VS).
Operator’s Manual 10-7
Theory of Operations
Note:
The allowable incremental value above the target pressure is 1.5 cmH
2
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
2
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
2
O.
Figure 10-4. Exhalation via the Airway Pressure Method
10-8
1
2
3
Pressure target
Pressure target +incremental value (n)
Start breath
4
5
200 ms
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 value of current flow to peak flow (expressed as a percentage) is less than or equal to the set E
SENS
value. The ventilator then cycles from inspiration into exhalation.
Reference Exhalation via the Percent Peak Flow Method , p. 10-9 for an example of exhalation using
the percent peak flow method.
Operator’s Manual
Exhalation — Detection and Initiation
Figure 10-5. Exhalation via the Percent Peak Flow Method
1
2
3
Inspiratory flow (0 L/min)
Inspiration
Trigger
5
6
7
Event B: Ventilator initiates exhalation
Inspiratory flow (L/min) without expiratory trigger
V
MAX
x E
SENS
/100
4 Event A: delivered flow begins to decrease ( V
MAX
)
Note:
PAV+ uses a flow-based cycling method, also called E
SENS
but it is expressed in L/min rather than in % of
V
MAX
.
10.5.3
Time-cycling Method
In pressure ventilation, the set inspiratory time (T
I
) defines the duration of the inspiratory phase.
In volume ventilation, T
I
depends on the tidal volume (V
T
) setting, peak flow ( V
MAX
), flow pattern, and plateau time (T
PL
). The ventilator cycles into exhalation when the set T
I
(pressure ventilation) or computed T
I
(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 x
PBW (kg)] s .
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.
Operator’s Manual 10-9
Theory of Operations
• High ventilator pressure limit — The ventilator transitions from inspiration to exhalation if the high ventilator pressure (
2
P
VENT
) limit of 110 cmH
2
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
2
V
TI
.
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.
Figure 10-6. Square Flow Pattern
10-10
1
2
3
Flow (y-axis)
Actual V
MAX
Set V
MAX
4
5
6
Compliance volume (VC)
Set V
T
T
I
Operator’s Manual
Figure 10-7. Descending Ramp Flow Pattern
Compliance and BTPS Compensation
3
4
1
2
Flow (y-axis)
Actual V
MAX
Set V
MAX
Compliance volume (VC)
5
6
7
Set V
T
T
I
Minimum V
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):
Factor = pt ckt
C pt
C pt
Compliance of the patient Factor Compliance volume factor
C pt ckt
Compliance of the patient circuit
The compliance volume is calculated as
Operator’s Manual 10-11
Theory of Operations
V
C
Compliance volume
V
C
= C pt ckt
( P wye
– P )
P wye
Pressure at the patient wye at the end of the current inspiration
C pt ckt
Compliance of the patient circuit P Pressure at the end of the current exhalation
Without automated compliance compensation, practitioners would have to compute V
C
to estimate the loss of volume in the patient circuit, then increase the V
T
setting by that amount. Increasing the tidal volume by a single 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.
An iterative algorithm in the ventilator automatically computes the compliance volume and compensates for it. Compliance compensation does not change inspiratory time (T
I
). It is achieved by increasing flow (increasing the amplitude of the selected flow pattern). Keeping T
I
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 the following table for adult, pediatric, and neonatal circuit types. Factor is calculated as:
MIN (10, MAX (2.5, 1.0 + (2.0/0.3 x kg PBW)))
10-12 Operator’s Manual
Mandatory Breath Delivery
Table 10-1. Compliance Volume Factors
Adult patient circuit type
PBW (kg) Factor
≤ 10
15
5
4.6
30
60
≥ 150
3.4
2.75
2.5
Pediatric patient circuit type
PBW (kg) Factor
≤ 10
11
5
3.5
12.5
15
30
2.9
2.7
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 2 P
PEAK
alarm setting to truncate the breath and switch to exhalation.
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 b
) is calculated using the breath rate ( f ) according to the equation
T b
= 60 ⁄ f
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.
Operator’s Manual 10-13
Theory of Operations
•
•
•
•
•
Reference Ventilator Settings Range and Resolution , p. 11-9 for details on the following VC+ set-
tings:
Expiratory time (T
E
)
I:E ratio
Inspiratory time (T
I
)
Rise time %
Target or tidal volume (V
T
)
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. Reference Ideal Waveform Using Square Flow Pattern
Waveform Using Descending Ramp Flow Pattern . The inspiration time is determined indirectly by
the characteristics of the selected flow wave.
Figure 10-8. Ideal Waveform Using Square Flow Pattern
10-14 Operator’s Manual
1
2
3
Pressure (cmH
2
O)
Flow (L/min)
Volume (mL)
4
5
6
Inspiration phase
Expiration phase
Constant flow
Figure 10-9. Ideal Waveform Using Descending Ramp Flow Pattern
Mandatory Breath Delivery
1
2
3
Pressure (cmH
2
O)
Flow (L/min)
Volume (mL)
4
5
6
Inspiration phase
Expiration phase
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 exhala-
tained for a time given by the set inspiration time, following 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.
Operator’s Manual 10-15
Theory of Operations
Figure 10-10. Ideal Waveform Using Pressure Control Ventilation
10-16
1
2
3
4
Pressure (cmH
2
O)
Flow (L/min)
Volume (mL)
Target pressure
5
6
7
PEEP
Inspiration phase
Expiration phase
10.7.3
VC+
VC+ breaths require initialization and must go through a startup routine.
VC+ Startup
During VC+ startup, the ventilator delivers at least one breath (test breath) to determine the pressure target needed to deliver the desired (set) volume. During the time the ventilator is delivering the test breaths, the message “VC+ startup” is displayed in the GUI’s prompt area.
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 in order to deliver the set volume (V
T
). In order to reach the desired volume promptly, the maximum allowed pressure adjustments for an Adult or Pediatric patient will be greatest during the first five breaths following Startup or a change in V
T
or V
T SUPP
The values of the maximum pressure adjustments for each patient type are summarized below.
Operator’s Manual
Mandatory Breath Delivery
Conditions
Table 10-2. Maximum Pressure Adjustments
PBW ≥ 25 kg
Maximum change in target pressure
15 ≤ PBW < 25 kg PBW < 15 kg
± 10.0 cmH
2
O ± 6.0 cmH
2
O ± 3.0 cmH
2
O Less than five breaths after:
VC+ startup or Change in V
T
Five breaths or more after VC+ startup
± 3.0 cmH
2
O ± 3.0 cmH
2
O ± 3.0 cmH
2
O
•
•
•
Reference Non-technical Alarm Summary , p. 6-16 for details on the following VC+ alarms:
VOLUME NOT DELIVERED
HIGH INSPIRED TIDAL VOLUME (
1
V
TI
)
LOW CIRCUIT PRESSURE (
3
P
PEAK
)
• COMPLIANCE LIMITED V
T
During VC+, inspiratory target pressure cannot be lower than PEEP + 3 cmH
2
O and cannot exceed
2 P
PEAK
- 3 cmH
2
O.
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
2
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%.
Operator’s Manual 10-17
Theory of Operations
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 exhalation phase where an inspiration trigger is not allowed. The restricted phase of exhalation is defined as the first 200 ms 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 five (5) s 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.
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
SUPP
) for PS,
Support volume (V
T SUPP
) for VS or percent support for TC and PAV+ (if the PAV+ option is installed) and specify the rise time % and E
SENS
, where available. Changes to the spontaneous breath type setting phase in at the start the next inspiration.
Note:
In any delivered spontaneous breath, either INVASIVE or NIV, there is always a target inspiratory pressure of at least 1.5 cmH
2
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.
10-18 Operator’s Manual
Operator’s Manual
Spontaneous Breath Delivery
Spontaneous type = VS
Table 10-3. Spontaneous Breath Delivery Characteristics
Characteristic
Inspiratory detection
Pressure or flow during inspiration
Spontaneous type = PS and P
SUPP
Pressure or flow during inspiration
Spontaneous type = PS and P
SUPP
Pressure or flow during inspiration
Tube Compensation (TC)
Inspiratory flow profile
Exhalation valve during inspiration
< 5 cmH
2
≥ 5 cmH
2
Inspiratory valve during inspiration
O
O
Implementation
P
SENS or V
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:
P
SUPP
Effective pressure (cmH
2
O)
0 1.5
1 2.2
2 2.9
3 3.6
4 4.3
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,Reference Volume Support (VS) , p.
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 help the patient overcome part or all of the resistance of the artificial airway. The ventilator continuously calculates the pressure differential and adjusts the compensation pressure accordingly. For more information regard-
ing TC, Reference Tube Compensation , p. 10-22.
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.
Adjust to maintain target pressure.
Because the exhalation valve acts as a relief valve venting any excess flow, inspiratory flow can be delivered aggressively and allows reduced work of breathing.
10-19
Theory of Operations
Table 10-3. Spontaneous Breath Delivery Characteristics (Continued)
Characteristic
Expiratory detection
Pressure or flow during exhalation
Inspiratory valves during exhalation
Exhalation valve during exhalation
Implementation
The end-inspiratory flow or airway pressure method, whichever detects exhalation first. Time backup and the 1 P
PEAK
alarm are also available as backup strategies.
Pressure is controlled to PEEP.
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.
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.
•
Reference Ventilator Settings Range and Resolution , p. 11-9 for details regarding the following VS
settings:
Expiratory sensitivity (E
SENS
)
Rise time %
Target support volume (V
T SUPP
)
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
10-20 Operator’s Manual
Spontaneous Breath Delivery 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 (5) breaths of VS initiation or startup.
During VS, the inspiratory pressure target cannot be lower than
PEEP + 1.5 cmH
2
O, and cannot exceed 2 P
PEAK
- 3 cmH
2
O.
VS Startup
During startup, the ventilator delivers a breath (test breath) to determine the pressure target needed to deliver the desired (set) volume. During the time the ventilator is delivering the test breath, the message “VS startup” is displayed in the GUI’s prompt area.
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 in order to deliver the set volume (V
T SUPP
). In order to reach the desired volume promptly, the maximum allowed pressure adjustments for an Adult or Pediatric patient will be greatest during the first five breaths following Startup or a change in V
T SUPP
. The values of the maximum pressure adjustments for each patient type are summarized in the table below.
Conditions
Table 10-4. Maximum Pressure Adjustments
PBW ≥ 25 kg
± 10.0 cmH
2
O
Maximum change in target pressure
15 kg ≤ PBW < 25 kg
± 6.0 cmH
2
O
PBW < 15 kg
± 3.0 cmH
2
O Less than five breaths after:
VS startup or change in
V
T SUPP
Five breaths or more after VS startup
± 3.0 cmH
2
O ± 3.0 cmH
2
O ± 3.0 cmH
2
O
•
•
•
Reference Non-technical Alarm Summary , p. 6-16 for details on the following VS alarms:
VOLUME NOT DELIVERED
COMPLIANCE LIMITED V
T
HIGH INSPIRED TIDAL VOLUME (
1
V
TI
)
Operator’s Manual 10-21
Theory of Operations
Monitored Patient Data
Reference Ventilator Settings Range and Resolution , p. 11-9 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.
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%.
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 (if this option is installed) 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 ms , 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 contin-
10-22 Operator’s Manual
Spontaneous Breath Delivery ually adjusted, adjusting the circuit pressure to match the changing tube-pressure compensation requirements.
Tube Compensation Alarms
Reference Non-technical Alarm Summary , p. 6-16 for details of the
1 P
COMP
, 1 P
VENT
, and 1 V
TI
alarms associated with TC.
Monitored Patient Data
(V
TI
) monitored patient data parameter a associated with TC.
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.
Ventilator Settings/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
2
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
2
O for available tube sizes and gas flows is shown.
Reference ET Tube Target Pressure vs. Flow , p. 10-24 and
Reference Tracheostomy Tube Target Pressure vs. Flow , p. 10-25. The estimated com-
pensation must be added to the value of PEEP for calculation and setting of 2 P
PEAK
.
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 below:
Operator’s Manual 10-23
Theory of Operations
W = k × ( P
E END
– dt
P ) × V dt
-----------------------------------------------------------------
W
P
E END
Work [J/L]
End expiratory pressure
P
TR k
Tracheal pressure
Conversion constant (0.098) [J/cmH
2
O x L)
The following figures 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.
Figure 10-11. ET Tube Target Pressure vs. Flow
10-24
1 Pressure (cmH
2
O) 2 Flow (L/min)
Operator’s Manual
Figure 10-12. Tracheostomy Tube Target Pressure vs. Flow
A/C Mode
1 Pressure (cmH
2
O) 2 Flow (L/min)
10.8.4
Proportional Assist Ventilation (PAV™+)
PAV+ is another type of spontaneous breath, which is available only if the PAV+ option is installed.
For detailed description of the operating theory,
in this manual.
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. Reference Mandatory Breath Delivery , p. 10-13
for a more detailed explanation of VC+ breaths. As for any mandatory breath, the triggering methods can be P
TRIG
, V
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:
T b
= 60 ⁄ f
Operator’s Manual 10-25
Theory of Operations where:
T b
= breath period ( s ) 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:
T
E
= T b
– T
I where:
T
E
= length of the expiratory phase (s)
T
I
= length of inspiratory phase (s) including plateau time, T
PL
The figure shown below illustrates A/C breath delivery when there is no patient inspiratory effort detected (all inspirations are VIMs).
Figure 10-13. No Patient Inspiratory Effort Detected
1 VIM 2 T b
The figure below 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 10-14. Patient Inspiratory Effort Detected
10-26
1 PIM 2 T b set
The figure shown below illustrates A/C breath delivery when there are both PIM and VIM breaths delivered.
Operator’s Manual
A/C Mode
Figure 10-15. Combined VIM and PIM Breaths
1
2
VIM
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 five (5) s 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.
Operator’s Manual 10-27
Theory of Operations
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. Reference the figure below which shows the two parts of the SIMV breath period.
Figure 10-16. Mandatory and Spontaneous Intervals
1 T b
= SIMV breath period (includes T m
and T s
3 T s
= Spontaneous interval (VIM delivered if no
PIM delivered during T m
2 T m
= Mandatory interval (reserved for a PIM breath)
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 m
interval ends and the ventilator switches to the second part of the period, the spontaneous interval ( T s
), 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. The following figure 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 10-17. PIM Delivered Within Mandatory Interval
10-28
1
2
PIM 3
T m
( T m
transitions to T s
when a PIM is delivered)
4
T s
(subsequent trigger efforts during
T s
yield spontaneous breaths)
T b
Operator’s Manual
SIMV Mode
The following figure shows an SIMV breath period where a PIM is not delivered within the mandatory interval.
Figure 10-18. PIM Not Delivered Within Mandatory Interval
1
2
VIM 3
T m
(VIM delivered at end of T m
if no
PIM delivered during T m
4
T s
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:
T b
= 60 ⁄ f
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 s
begins, and any further 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.
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 T m
to transition to T s
.)
•
The maximum mandatory interval for any valid respiratory rate setting in SIMV is defined as the lesser of:
0.6 x the SIMV interval period ( T b
), or
Operator’s Manual 10-29
Theory of Operations
• ten s .
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 x the SIMV period interval (but no longer than the period interval + ten (10) s). 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 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 delivered during T s
.
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
I
, current T
A
, or the length of the current breath period.
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
I
or current T
A
.
10-30 Operator’s Manual
SIMV Mode
• If the current mode is BiLevel in the P
H
state and the current breath is mandatory, the PEEP level will be reduced to P
L
once the exhalation 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 x duration of the active gas delivery phase, or
•
– the length of the apnea interval (T
A
), or
– the length of the current breath cycle
If the current mode is BiLevel in the P
H
state and the current breath is spontaneous, the PEEP level will be reduced once the exhalation 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 x duration of the spontaneous inspiration, or
•
•
•
– the start time of the spontaneous breath + the length of the apnea interval (T
A
).
If the current mode is BiLevel in the P
L
state and the current breath is mandatory, the time t until the first VIM of the new A/C mode is the lesser of:
– PEEP transition time + 2.5 x duration of the active gas delivery phase, or
– the length of the apnea interval (T
A
), or
– the length of the current breath cycle
If the current mode is BiLevel in the P
L
state and the current breath is spontaneous and the spontaneous start time has occurred during P
L
, the time t until the first VIM of the new A/C mode is the lesser of:
– 3.5 x duration of the spontaneous inspiration, or
– the length of the apnea interval (T
A
) or
– the length of the current breath cycle
If the current mode is BiLevel in the P
L
state and the current breath is spontaneous and the spontaneous start time has occurred during P
H
, the time t until the first VIM of the new A/C mode is the lesser of:
– PEEP transition time + 2.5 x duration of the spontaneous inspiration, or
– the start time of the spontaneous breath + the length of the apnea interval (T
A
).
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.
Operator’s Manual 10-31
Theory of Operations
•
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
I
) 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 x the last or current T
I
, but not greater than the current SIMV period interval.
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+ (if the PAV+™ option is installed)
The inspiratory phase begins when the ventilator detects patient effort during the ventilator’s exhalation 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+) (if the PAV+™, option is installed) 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.
10-32 Operator’s Manual
Apnea Ventilation
•
•
•
•
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
I
too long)
1
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 exhalation 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 operatorselected 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 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 s 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
Operator’s Manual 10-33
Theory of Operations features that temporarily extend the inspiratory or expiratory intervals (rate changes, for example), but still detect a true apnea event.
The figure below shows an apnea breath where T
A
equals the breath period.
Figure 10-19. Apnea Interval Equals Breath Period
1
2
T b0
T b1
3
4
PIM
T
A
(apnea interval)
The figure below shows an apnea breath with T
A
greater than the breath period.
Figure 10-20. Apnea Interval Greater Than Breath Period
1
2
3
T b0
T b1
PIM
4
5
VIM
T
A
(apnea interval)
The following figure shows an apnea breath with T
A
less than the breath period.
10-34 Operator’s Manual
Figure 10-21. Apnea Interval Less Than Breath Period
Apnea Ventilation
1
2
3
4
5
T b0
T b1
PIM
Dashed line indicates a PIM to avoid apnea
Apnea VIM
6
7
8
9
Apnea interval
Apnea T b0
Apnea ventilation
T b
( T
A
< 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 nonapnea 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
2
control is active during apnea ventilation, because apnea detection is likely during suctioning.
The apnea respiratory rate must be ≥ 60/T
A
Additionally, apnea settings cannot result in an I:E ratio > 1.00:1.
Operator’s Manual 10-35
Theory of Operations
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. 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.
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
A
) elapses at any time during the mandatory interval, the ventilator delivers a VIM rather than beginning apnea ventilation.
• If T
A
elapses during the spontaneous interval, apnea ventilation begins.
The figure below shows an illustration of how SIMV is designed to deliver a VIM rather than trigger apnea ventilation, when possible.
Figure 10-22. Apnea Ventilation in SIMV
10-36
1 T b
2 Last breath (PIM)
3 VIM
4 T m max
5 T
A
6 T m
(If T
A
elapses during T m
, ventilator delivers a VIM rather than beginning apnea ventilation
7 T s
Operator’s Manual
Detecting Occlusion and Disconnect
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 in order 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 exhalation valve fails in the closed position (occlusion detection at the From patient port begins after 195 ms of exhalation has passed.)
•
•
•
The ventilator does not detect a severe occlusion if:
The pressure difference between the inspiratory and the expiratory transducers is less than or equal to
5 cmH
2
O.
The exhalation valve fails in the closed position and the pressure in the exhalation limb is less than 2 cmH
2
O.
Silicone tubing is attached to the EXHAUST port of the ventilator (i.e. for metabolic monitoring purposes).
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.
Operator’s Manual 10-37
Theory of Operations
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 alarm silence, annunciates an occlusion alarm, and enters the safe state (exhalation and inspiratory valve de-energized and safety valve open) for 15 s or until inspiratory pressure drops to 5 cmH
2
O or less, whichever comes first.
During a severe occlusion, the ventilator enters OSC, in which it periodically attempts to deliver a pressure-based breath while monitoring the inspiration and expiration 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
2
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
2
% equal to 100% for adult/pediatric circuit types or 40% for neonatal circuits.
During OSC (and only during OSC), the 2 P
PEAK
(high circuit pressure) alarm limit is disabled to ensure it does not 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.
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 s .
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.
10-38 Operator’s Manual
Detecting Occlusion and Disconnect
•
•
•
•
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/or large leaks, it is possible for a patient to generate some exhaled flow and pressure. The ventilator then uses the disconnect sensitivity
(D
SENS
, the percentage of delivered volume lost during the exhalation phase of the same breath to declare a disconnect) setting to detect 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
2
T
I SPONT
limit setting when Vent 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
setting and pressure less than 0.5 cmH
2
O detected for ten (10) consecutive seconds during exhalation.
WARNING:
When vent type is NIV, and D
SENS
setting is turned OFF, the system may not sound an alarm for leaks and some disconnect conditions.
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 silence when the disconnect occurs, the alarm silence 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 at 100% O
2
or 40% O
2
in NeoMode, if available 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 or,
Inspiratory pressure rises to a reconnect level.
•
Operator’s Manual 10-39
Theory of Operations
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
•
•
•
•
•
•
•
Reference Respiratory Mechanics Maneuvers , p. 4-25 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
) and Dynamic Resistance (R
DYN
), Peak Expiratory Flow (PEF), End Expiratory Flow (EEF), C
20
/C, and Peak Spontaneous Flow (PSF).
•
Respiratory maneuvers can be performed in all breathing modes (except as noted below) 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
10-40 Operator’s Manual
Respiratory Mechanics
•
•
•
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:
1
P
PEAK
alarm
1
P
VENT
alarm
1
V
TI
•
•
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, Reference Respiratory Mechanics
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 calculate these pressures, the inspiratory and exhalation valves are closed, allowing pressures on both sides of the artificial airway 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
H
to P
L
. Only one inspiratory pause is allowed per breath. An inspiratory pause cannot occur during apnea ventilation, safety PCV, Stand-by state,
Occlusion, and SVO.
An automatic inspiratory pause begins when the inspiratory pause key is pressed momentarily
Menu tab on the GUI rather than using the keys on the GUI. The pause lasts at least 0.5 s but no longer than three (3) s . A manual inspiratory pause starts by pressing and holding the inspiratory pause key. The pause lasts for the duration of the keypress (up to seven (7) s ).
Operator’s Manual 10-41
Theory of Operations
•
An active manual inspiratory pause is considered complete if any of the following occur:
The inspiratory pause key is released and at least two (2) s of inspiratory pause have elapsed or pressure stability conditions have been detected for not less than 0.5 s .
• Pause duration reaches seven (7) s .
A manual inspiratory pause maneuver request (if the maneuver is not yet active) will be canceled
if any of events 1- 10 occur. Reference Inspiratory and Expiratory Pause Events
.
3
4
5
6
7
8
9
10
11
12
13
14
15
Table 10-5. Inspiratory and Expiratory Pause Events
Event Identifier
1
2
Event
There is a loss of communications with the GUI
High ventilator pressure limit ( 2 P
VENT
) is reached
High circuit pressure limit ( 2 P
PEAK
) is reached
A disconnect is detected
Occlusion is detected
Apnea is detected
72 seconds have elapsed without an inspiratory pause after one has been requested
INSPIRATION TOO LONG alarm is detected
High inspired tidal volume ( 1 V
TI
) alarm is detected
High compensation pressure ( 1 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. Reference Inspiratory and Expiratory Pause Events , p. 10-42.
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. Reference Inspiratory and Expiratory Pause Events , p. 10-42.
10-42 Operator’s Manual
Respiratory Mechanics
•
•
•
•
•
The active automatic inspiratory pause maneuver is considered complete if the pause duration reaches three seconds or pressure stability conditions have been detected for not less than 0.5 s .
An automatic inspiratory pause maneuver request (if the maneuver is not yet active) will be can-
celed if events 1-9, 11,12,14, or 15 occur. Reference Inspiratory and Expiratory Pause Events
.
•
Other characteristics of inspiratory pause include:
During an inspiratory pause, the apnea interval (T
A
) 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 inspiration 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 exhalation phase of a single breath in order to measure end expiratory lung pressure (PEEP
L
) and allows intrinsic PEEP (PEEP
I
) to be calculated as PEEP
L
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 end-of-exhalation prior to a transition from P
L
to P
H
. 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. Reference To access respiratory mechanics maneuvers , p. 4-25 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 s , but no longer than 3.0 s . 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 s ).
An active manual
Operator’s Manual 10-43
Theory of Operations
•
•
•
An active manual expiratory pause is complete if the expiratory pause key is released and at least three (3) s of expiratory pause have elapsed, pressure stability conditions have been detected for
≥ 0.5 s , or pause duration lasts 15 s .
An active automatic
expiratory pause is terminated if any of events 1, 3, or 11-13 occur.Reference
Inspiratory and Expiratory Pause Events , p. 10-42.
An active automatic expiratory pause is complete if pause duration reaches three (3) s or pressure stability conditions have been detected for ≥ 0.5 s , or pause duration lasts 15 s .
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. Reference Inspiratory and Expiratory Pause Events , p. 10-42.
•
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 exhalation 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
1
P
PEAK
alarm is declared
1
P
VENT
alarm is declared
1
V
TI
alarm is declared
Communications with the GUI is lost
The maneuver has been active for 30 s and an inspiration is not detected
10-44 Operator’s Manual
Respiratory Mechanics
•
•
INSPIRATION TOO LONG alarm is declared
A manual inspiration is requested
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)
•
•
•
•
•
•
•
•
P
0.1
is the negative airway pressure (delta pressure change) generated during the first 100 ms 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
0.1
maneuver is terminated if seven (7) s elapse and a trigger has not been detected to activate the maneuver.
•
A P
0.1
maneuver is canceled if:
Disconnect is detected
Occlusion is detected
SVO is detected
1 P
PEAK
alarm is declared
1 P
VENT
alarm is declared
1
V
TI
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.
Operator’s Manual 10-45
Theory of Operations
•
•
•
•
•
•
•
•
•
•
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
1
P
PEAK
alarm is declared
1
P
VENT
alarm is declared
1
V
TI
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 s and inspiration is not detected
Cancel is touched
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
A
) set by the operator. T
A
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
A
)
Inspiratory pressure (P
I
)
Inspiratory time (T
I
)
Respiratory rate ( f )
10-46 Operator’s Manual
Ventilator Settings
•
•
•
•
•
For VC breaths, the allowable settings are:
Apnea interval (T
A
)
Flow pattern
O
2
%
Peak inspiratory flow (
V
MAX
)
Respiratory rate ( f )
• Tidal Volume (V
T
)
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
I
).
If apnea is possible (that is, if (60/f) > T
A
) increasing the non-apnea O
2
% setting automatically changes apnea ventilation O
2
% if it is not already set higher than the new non-apnea O
2
%. Apnea ventilation O
2
% does not automatically change by decreasing the non-apnea O
2
%. 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
A
during apnea ventilation can avoid immediately re-entering apnea ventilation once normal ventilation resumes.
Because the minimum value forT
A
is 10 s , apnea ventilation cannot take place when non-apnea f is greater than or equal to 5.8 1/min.The ventilator does not enter apnea ventilation if T
A
is equal to the breath period interval. Set T
A
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
T
) and Peak flow ( V
MAX
). Run
SST in order to change the circuit type.The table below gives the minimum, maximum, and new patient default values for V
T
based on circuit type.
Operator’s Manual 10-47
Theory of Operations
Circuit Type
Neonatal
Pediatric
Adult
Table 10-6. Values for V
T
Based on Circuit Type
New Patient Default
When mandatory type is VC+, MAX {2 mL, (mL/ kg Ratio x PBW)} mL;
When mandatory type is VC, MAX {3 mL, (mL/kg
Ratio x PBW)} mL mL/kg ratio x PBW mL mL/kg ratio x PBW mL
Minimum V
T
2 mL if NeoMode 2.0 software option is installed
25 mL
25 mL
Maximum V
T
315 mL
1590 mL
2500 mL
Reference Ventilator Settings Range and Resolution , p. 11-9, V
T
setting, for more information on V
T calculations based on PBW and circuit type.
Table 10-7. Peak Flow and Circuit Type (Leak Sync Disabled)
Circuit Type
Neonatal
Pediatric
Adult
Maximum peak flow
( V
MAX
) setting
30 L/min
60 L/min
150 L/min
PBW determines constants for breath delivery algorithms, some user-settable alarms, the high spontaneous inspiratory time limit setting ( 2 T
I SPONT
) in NIV, and the non-settable INSPIRATION
TOO LONG alarm.
10.15.3
Vent Type
•
There are two Vent 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 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 ( 2 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.)
10-48 Operator’s Manual
Ventilator Settings
• 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 Vent Types.
Table 10-8. Modes and Breath Types
Mode
A/C
SIMV
CPAP
Mandatory Breath
Type
INVASIVE: VC, VC+ or PC
NIV: VC or PC
INVASIVE: PC, VC, or VC+
NIV: VC or PC
VC or PC (allowed only for OIM breaths)
Spontaneous Breath Type
Not allowed
Pressure supported (PS) or TC
SPONT
BiLevel (INVASIVE vent type only)
Not allowed (PC or VC allowed only for manual inspirations).
PC
INVASIVE: Pressure supported
(PS), Tube compensated (TC),
Volume supported (VS), Proportionally assisted (PAV+)
NIV: PS
PS, TC
N/A
Sequence
All mandatory (patient-, ventilator-, or operatorinitiated).
Each new breath begins with a mandatory interval, during which a patient effort yields a synchronized mandatory breath. If no patient effort is detected 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).
Combines mandatory and spontaneous breathing modes.
for more information on
BiLevel ventilation.
All spontaneous (except for manual Inspirations).
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 pres-
Operator’s Manual 10-49
Theory of Operations sure 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+), if the PAV+ option is installed. The figure below shows the modes and breath types available on the ventilator.
A/C,
SIMV,
SPONT,
BiLevel
PC
Mandatory
VC VC+ PS TC
Spontaneous
VS PAV+
•
•
•
•
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.
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 flow- or 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 ventilatorinitiated mandatory breaths in A/C, SIMV, and BiLevel modes.If the mode is A/C or SIMV and VC is the breath type, specifying V
MAX
and flow pattern determines T
I
, T
E
, and I:E. In PC breaths, specifying T
I
automatically determines the other timing variables. Reference Inspiratory Time , p. 10-53
for an explanation of the interdependencies of f , T
I
, T
E
and I:E. Changes to the f setting are phased in at the start of inspiration.
10-50 Operator’s Manual
Ventilator Settings
The ventilator does not accept a proposed f setting if it would cause the new T
I
or TE to be less than 0.2 second, the T
I
to be greater than eight(8) s , 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
L
is reached.
10.15.6
Tidal Volume
The tidal volume (V
T
) setting determines the volume of gas delivered to the patient during a VC mandatory breath. The delivered V
T
is compensated for BTPS and patient circuit compliance.
Changes to the V
T
setting are phased in at the start of inspiration. The V
T
setting only affects the delivery of mandatory breaths.
When proposing a change to the V
T
setting, the ventilator compares the new value with the settings for f,
V
MAX
, flow pattern, and T
PL
. If the proposed setting would result in an I:E ratio that exceeds 4.00:1 or a T
I
greater than eight(8) s or less than 0.2 s , or a T
E
less than 0.2 s , the ventilator disallows the change.
10.15.7
Peak Inspiratory Flow
The peak inspiratory flow ( V
MAX
) setting determines the maximum rate of delivery of tidal volume to the patient during mandatory VC breaths, only. Changes to V
MAX
are phased in at the start of inspiration. Mandatory breaths are compliance compensated, even at the maximum V
MAX
setting. Circuit compliance compensation does not cause the ventilator to exceed the ventilator’s maximum flow capability.
When proposing a change to the V
MAX
setting, the ventilator compares the new value with the settings for V
T
, f, flow pattern, and T
PL
. It is impossible to set a new V
MAX
that would result in an I:E ratio that exceeds 4.00:1, or a T
I
greater than 8.0 s or less than 0.2 s , or a T
E
less than 0.2 s .
10.15.8
Plateau Time
The plateau time (T
PL
) setting determines the amount of time inspiration is held in the patient's airway after inspiratory flow has ceased.T
PL
is available only during VC mandatory breaths (for A/
C and SIMV mode, and operator-initiated mandatory breaths). T
PL
is not available for PC mandatory breaths. Changes to the T
PL
setting are phased in at the start of inspiration.
When proposing a change to the T
PL
setting, the ventilator computes the new I:E ratio and TI, given the current settings for V
T
, f,
V
MAX
, and flow pattern. It is impossible to set a new T
PL
that would result in an I:E ratio that exceeds 4.00:1, or a T
I
greater than eight s or less than 0.2 s , or a T
E less than 0.2 s . For the I:E ratio calculation, T
PL
is considered part of the inspiration phase.
Operator’s Manual 10-51
Theory of Operations
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
T flow patterns. If V
T
and V
MAX
and
V
MAX
apply to both the square or descending ramp
and are held constant, T
I
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
T
,f, T
PL
, and V
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
I
> 8.0 s or T
I
< 0.2 s
T
E
< 0.2 s
10.15.10
Flow Sensitivity
The flow sensitivity ( V
SENS
) setting defines the rate of flow inspired by a patient that triggers the ventilator to deliver a mandatory or spontaneous breath. When V
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
V
SENS
+ 1.5 L/min (base flow is not user- selectable). When the patient inhales and their inspiratory flow exceeds the V
SENS
V
SENS
setting, a trigger occurs and the ventilator delivers a breath. Reductions to
are phased in immediately, while increases are phased in at the start of exhalation.
When
V
SENS
is active, it replaces pressure sensitivity (P
SENS
P
SENS
setting. V
SENS
). The
V
SENS controlled, pressure controlled, and apnea ventilation). When V
SENS
setting has no effect on the
can be active in any ventilation mode (including pressure supported, volume
is active, a backup P
SENS setting of 2 cmH
2
O is in effect to detect the patient's inspiratory effort, even if the flow sensors do not detect flow.
Although the minimum V
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
SENS
) setting selects the pressure drop below baseline (PEEP) required to begin a patient-initiated breath (either mandatory or spontaneous). Changes to P
SENS
are
10-52 Operator’s Manual
Ventilator Settings phased in immediately. The P
SENS
setting has no effect on the V
SENS
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
SENS
setting avoids autotriggering under worst-case conditions if patient circuit leakage is within specified limits.
10.15.12
Inspiratory Pressure
The inspiratory pressure (P
I
) setting determines the pressure at which the ventilator delivers gas to the patient during a PC mandatory breath. The P
I
setting only affects the delivery of PC mandatory breaths. The selected P
I
is the pressure above PEEP. (For example, if PEEP is set to five cmH
2
O, and P
I
is 20 cmH
2
O, the ventilator delivers gas to the patient at 25 cmH
2
O.) Changes to the P
I
setting are phased in at the start of inspiration.
The sum of PEEP + P
I
+ 2 cmH
2
O cannot exceed the high circuit pressure ( 2 P
PEAK
) limit. To increase this sum of pressures, first raise the
2
P
PEAK
limit before increasing the settings for PEEP or P
I
. The minimum value for P
I
is
5 cmH
2
O and the maximum value is 90 cmH
2
O.
10.15.13
Inspiratory Time
The inspiratory time (T
I
setting) determines the time during which an inspiration is delivered to the patient for PC mandatory breaths. The ventilator accepts a setting as long as the resulting I:E ratio and T
E
settings are valid. Changes to T
I
phase in at the start of inspiration. Directly setting T
I 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
I
greater than eight
(8) s or less than 0.2 s , or a T
E
less than 0.2 s to ensure the patient has adequate time for exhalation.
Setting f and T
I
automatically determines the value for I:E and T
E
.
60 ⁄ f – T
I
= T
E
This equation summarizes the relationship between T
I
, I:E, T
E
, and breath period time:
T
I
=
f
( ( I : E ) ⁄ ( 1 + I : E ) )
If the f setting remains constant, any one of the three variables (TI, I:E, or TE) can define the inspiratory and expiratory intervals. If the f setting is low (and additional spontaneous patient efforts
Operator’s Manual 10-53
Theory of Operations are expected), TI 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
, I:E,
T
E
and f .
10.15.14
Expiratory Time
The expiratory time (T
E
) setting defines the duration of exhalation for PC and VC+ mandatory breaths, only. Changes to the T
E
setting are phased in at the start of exhalation. Setting f and T
E automatically determines the value for I:E ratio and T
I
. Reference Inspiratory Time , p. 10-53 for an
explanation of the interdependencies of f , T
I
, T
E
, and I:E.
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
I
and T
E 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.
Reference Inspiratory Time , p. 10-53 for an explanation of the interdependencies of
f , T
I
, T
E
, and I:E.
Setting f and I:E automatically determine the values for T
I
and T
E
. 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
H
) 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
L
) 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
H
) setting is the duration of time (in seconds) the ventilator maintains the set high pressure level in BiLevel ventilation.
10-54 Operator’s Manual
Ventilator Settings
10.15.19
Low Time in BiLevel
The low time (T
L
) setting is the duration of time (in seconds) the ventilator maintains the set low pressure level in BiLevel ventilation.
10.15.20
T
H
:T
L
Ratio in BiLevel
The ratio of T
H
to T
L
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
2
O, or
PEEP + P
I
+ 2 cmH
2
O (if PC is active), or
• PEEP + P
SUPP
+ cmH
2
O (if PS is on) cannot exceed the
2
P
PEAK
limit. To increase the sum of pressures, first raise the
2
P
PEAK
limit before increasing the settings for PEEP, P
I
, or P
SUPP
.
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
2
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
SUPP
is only available in SIMV, SPONT, and
BiLevel, in which spontaneous breaths are allowed. The PSUPP setting is maintained as long as the patient inspires, and patient demand determines the flow rate. Changes to the 2 P
SUPP
setting are
Operator’s Manual 10-55
Theory of Operations phased in at the start of inspiration. The pressure support setting affects only spontaneous breaths.
The sum of PEEP + P
SUPP
+ 2 cmH
2 sures, first raise the 2 P
PEAK
O cannot exceed the 2 P
PEAK
limit. To increase the sum of pres-
limit before increasing the settings for PEEP or P
SUPP
. Since the 2 P
PEAK limit is the highest pressure considered safe for the patient, a P
SUPP
setting that would cause a
1 P
PEAK
alarm requires re-evaluating the maximum safe circuit pressure.
10.15.23
Volume Support
Volume support (V
T SUPP
) is defined as the volume of gas delivered to the patient during spontaneous VS breaths. Changes to the to the V
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
H
and P
L
phases.
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
2
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
I
(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
I
in two (2) s or 2/3 of the T
I
, whichever is shortest.
10-56 Operator’s Manual
Ventilator Settings
•
•
•
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 x PBW-based T
I
TOO LONG x 2/3) s .
When both PC and PS breaths are active, the slopes and thus the pressure trajectories can appear to be different. Changes to T
I
and P
I
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
2
O.
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
, exhalation begins. E
SENS
is a primary setting and is accessible from the GUI screen. Changes to E
SENS
are phased in at the next patientinitiated spontaneous inspiration.
E
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.
E
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: D
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 and vice versa.
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.
Operator’s Manual 10-57
Theory of Operations
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.
Refer to
for acceptable compliance and resistance ranges.
10.15.29
High Spontaneous Inspiratory Time Limit
The high spontaneous inspiratory time limit setting ( 2 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 transitions to exhalation. The default 2 T
I SPONT
setting is based upon circuit type and PBW.
For pediatric/adult circuit types, the new patient default value is
(1.99 + (0.02 x PBW)) s
For neonatal circuit types, the new patient default value is
((1.00 + (0.10 x PBW) s
The
1
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
2 T
I SPONT
setting. The 1 T
I SPONT
indicator disappears when the patient’s inspiratory time returns to less than the 2 T
I SPONT
setting, or after 15 s has elapsed after the beginning of exhalation of the last truncated breath. Changes to
2
T
I SPONT
are phased in at the start of inspiration.
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.
10-58 Operator’s Manual
Safety Net
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, patientventilator 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 or to have redundancy. The ventilator is designed to ensure that a singlepoint 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 the following table:
Operator’s Manual 10-59
Theory of Operations
Parameter
PBW mode mandatory Type f
TOT
(total respiratory rate)
T
P
O
2
I
I
%
PEEP
Trigger type
P
SENS
V
SENS
1 P
PEAK
1V
E TOT
alarm
3V
E TOT
alarm
1 V
TE
alarm
3 V
TE MAND
alarm
3 V
TE SPONT
alarm
Circuit type
Humidification type
Table 10-9. Safety PCV Settings
Safety PCV Value
Neonatal: 3 kg
Pediatric: 15 kg
Adult: 50 kg
A/C
PC
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
2
O
Neonatal: 40%
Pediatric: 100%
Adult: 100%
3 cmH
2
O
Neonatal: V
TRIG
Pediatric: P
TRIG
Adult: P
TRIG
2 cmH
2
O
1.0 L/min
20 cmH
2
O
OFF
0.05 L/min
OFF
OFF
OFF
Last set value, or adult if none available
Set value, or 'NON-HEATED EXP TUBE' if none available
Last set value, or 480 mL if none available Humidifier volume
Note:
In Safety PCV, expiratory pauses are not allowed.
10-60 Operator’s Manual
Safety Net
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. Reference Alarms , p. 6-4 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 three (3) s 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.
Reference Ventilator Protection Strategies , p. 4-30.
•
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
Operator’s Manual 10-61
Theory of Operations 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 and/or flow sensor signal out of range). In inspiratory BUV, ventilation continues with the following settings:
T
P
I
I
O
2
%
PEEP
Trigger type
Gas flow
Table 10-10. Inspiratory Backup Ventilation Settings
Backup Ventilation parameter
PBW
Mode f
Mandatory type
Setting
Previously used setting during Vent Startup
A/C
PC
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
2
O
100% (21% if O
2
not available)
3 cmH
2
O
V
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.
10-62 Operator’s Manual
Power On Self Test (POST)
•
•
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
2
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 subsystems and communication channels without operator intervention and takes approximately 12 s to complete.
If POST detects a major fault, qualified service personnel must correct the problem and successfully pass EST. Reference 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
a patient is connected.
Operator’s Manual 10-63
Theory of Operations
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. Reference EST (Extended Self Test) , p. 3-44.
WARNING:
Do not enter Service mode with a patient attached to the ventilator. Serious injury could result.
10-64 Operator’s Manual
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
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 < 50 psi (345 kPa) are employed.
11.2
Measurement Uncertainty
Measurement uncertainties and the manner in which they are applied are listed in the following tables unless otherwise noted:
11-1
Specifications
Flow
Pressure
Table 11-1. Performance Verification Equipment Uncertainty
Measured Parameter
Oxygen Concentration
Temperature
Atmospheric Pressure
Offset
0.1001 SLPM
0.121594 cmH
2
O
0.0168 %O
2
0.886041 °C
1.76 cmH
2
O
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) x (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.
11-2 Operator’s Manual
Physical Characteristics
11.3
Physical Characteristics
Table 11-2. Physical Characteristics
Weight
Dimensions
A-weighted sound pressure level, ventilator (average)
A-weighted sound pressure level, ventilator and compressor
A-weighted sound power level, ventilator
A-weighted sound power level, ventilator and compressor
Connectors
Inspiratory/ exhalation filters
Pressure units (chosen by operator)
Displayed weight units
Displayed length units
Ventilator: 113 lb (51.26 kg) including BDU, GUI, standard base, and primary battery
BDU only: 69 lb (31.3 kg)
Ventilator and compressor: 157 lb (71.2 kg) including GDU, GUI, ventilator and compressor primary batteries, base assembly, and compressor
Compressor: 89 lb (40.4 kg) including base assembly
BDU only: 69 lb (31.3 kg)
Ventilator: 12.5” width x 11.5” depth x 43.5” height
(32 cm x 30 cm x 111 cm) (not including GUI screen)
Ventilator: 12.5” width x 11.5” depth x 58” height
(32 cm x30 cm x 148 cm) (including GUI screen
Standard base: 22.5” width x 26” depth (58 cm x 66 cm)
At a distance of 1 meter does not exceed 48 dBA at 5 L/min
At a distance of 1 meter does not exceed 54 dBA at 5 L/min
Does not exceed 58 dBA below 500 mL/min
Does not exceed 63 dBA below 500 mL/min
Inspiratory and expiratory limb connectors are 22mm OD conical fittings compliant with ISO 5356-1
Refer to filter Instructions For Use for complete specifications
Hectopascal (hPa) centimeters of water (cmH
2
O)
Kilograms (kg) Pounds (lb)
Centimeters (cm) Inches (in)
Operator’s Manual 11-3
Specifications
11-4
Oxygen and air inlet supplies
Oxygen sensor life
Gas mixing system
Table 11-3. Pneumatic Specifications
Pressure: 241 to 600 kPa (35 psi to 87 psi)
Flow: Maximum of 200 L/min
Up to one year. Operating life varies depending on oxygen usage and ambient temperature.
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 11-4. Technical Specifications
Maximum limited pressure (PLIM max)
Maximum working pressure (P
W
Response time to change in FiO
O
2
to 90% O
2
2 max
)
setting from 21%
(measured at the patient wye)
A fixed pressure limit to the safety valve limits circuit pressure to < 123 hPa (125 cmH
2
O) at the patient wye.
P
W max
is ensured by the high pressure limit ( 2 P
PEAK
) when PI is < 100 cmH
2
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
Measuring and display devices Pressure Measurements:
Type: Solid state differential pressure transducer
Sensing position: Inspiratory module; expiratory module
Mean circuit pressure (P
MEAN
):
-20 cmH
2
O (-20 hPa) to 100 cmH
2
O (98 hPa)
Peak circuit pressure (P
PEAK
:-20 cmH
2
O (-20 hPa) to
130 cmH
2
O (127 hPa)
Volume Measurements:
Type: Hot film anemometer
Sensing position: Inspiratory module; expiratory module
Oxygen measurement:
Type: Galvanic cell
Sensing position: Inspiratory module
Minute volume ( V
E TOT
) capability, ventilator
Minute volume ( V
E TOT
) capability, compressor
Up to 75 L/min
Up to 40 L/min BTPS, including compliance compensation
Results of ventilator testing using circuits identified for use with the ventilator system
Internal Inspiratory filter bacterial/viral filtration efficiency
> 99.999%
Operator’s Manual
Operator’s Manual
Physical Characteristics
Table 11-4. Technical Specifications (Continued)
Internal Inspiratory filter particle filtration efficiency
Internal Inspiratory filter resistance
External Inspiratory filter resistance
Combined inspiratory limb resistance
> 99.97% retention of particles 0.3 mm nominal at
100 L/min flow
0.2 cmH
2
O < resistance < 2.2 cmH
2
O at 30 L/min flow
0.2 cmH
2
O < resistance < 1.7 cmH
2
O at 15 L/min flow
0.2 cmH
2
O < resistance < 2.2 cmH
2
O at 30 L/min flow
0.2 cmH
2
O < resistance < 2.2 cmH
2
O at 15 L/min flow
0.2 cmH
2
O < resistance < 5.5 cmH
2
O at 30 LL/min flow
0.2 cmH
2
O < resistance < 1.7 cmH
2
O at 15 L/min flow
External Inspiratory filter resistance 0.2 cmH
2
O < resistance < 2.2 cmH
2
O at 30 L/min flow
0.2 cmH
2
O < resistance < 1.7 cmH
2
O at 15 L/min flow
External Inspiratory filter bacterial/viral filtration efficiency, reusable
> 99.999%
External Inspiratory filter particle filtration efficiency > 99.97% retention of particles 0.3 mm nominal at
100 L/min flow
External Inspiratory filter resistance (reusable inspiratory filter)
0.2 cmH
2
O < resistance < 4.2 cmH
2
O at 60 L/min
0.2 cmH
2
O < resistance < 2.2 cmH
2
O at 30 L/min
0.2 cmH
2
O < resistance < 1.7 cmH
2
O at 15 L/min
> 99.999% External Inspiratory filter bacterial/viral filtration efficiency, disposable
External Inspiratory filter particle filtration efficiency, disposable inspiratory filter)
Exhalation filter bacterial/viral filtration efficiency, reusable
> 99.97% retention of particles 0.3 mm nominal at
100 L/minflow
Exhalation filter particle filtration efficiency, reusable > 99.97% retention of particles 0.3 mm nominal at
100 L/min flow
> 99.999%
Exhalation filter resistance (pediatric/adult, reusable and disposable)
< 2.5 cmH
2
O at 100 L/min when new
< 1.7 cmH
2
O at 15 L/min
> 99.999% Exhalation filter bacterial/viral filtration efficiency, disposable
Exhalation filter particle filtration efficiency, disposable
Exhalation filter resistance, disposable
> 99.97% retention of particles 0.3 mm nominal at
100 L/min flow
< 2.5 cmH
2
O at 100 L/min when new
11-5
Specifications
Table 11-4. Technical Specifications (Continued)
Exhalation filter particle filtration efficiency
> 99.97% retention of particles 0.3
m nominal at 100 L/min flow
> 99.999% 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 compliance for each patient type)
Inspiratory limb circuit resistance (acceptable ranges of VBS inspiratory limb circuit resistance for each patient type)
Expiratory limb circuit resistance (acceptable ranges of VBS expiratory limb circuit resistance for each patient type)
Audio alarm volume (primary)
Measurement uncertainty: ± 3 dBA
Audio alarm volume (secondary)
Measurement uncertainty: ± 3 dBA
> 99.70% retention of particles 0.3 μm nominal at 30
L/min flow
< 0.58 cmH
2
O at 2.5 L/min
ADULT: 1.3 mL/cmH
2
O to 4.2 mL/cmH
2
O
PEDIATRIC: 0.9 mL/cmH
2
O to 3.0 mL/cmH
2
O
NEONATAL: 0.4 mL/cmH
2
O to 1.5 mL/cmH
2
O
ADULT (at 60L/min): 1.15 cmH
2
O to 11.0 cmH
2
O
PEDIATRIC (at 30L/min): 0.46 cmH
2
O to 4.5 cmH
2
O
NEONATAL (at 10L/min): 0.37 cmH
2
O to 4.5 cmH
2
O
(6.0 cmH
2
O for Prox)
ADULT (at 60L/min): 1.15 ccmH
2
O to 11.0 cmH
2
O
PEDIATRIC (at 30L/min): 0.46 cmH
2
O to 4.5 cmH
2
O
NEONATAL (at 10L/min): 0.37 cmH
2
O to 4.5 cmH
2
O
(6.0 cmH
2
O for Prox)
Range: High priority alarm volume range (dBA): 58
(volume 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
Reference Alarm Volume Key , p. 6-7 for alarm volume
behavior during an alarm condition.
Resolution: 1
Minimum 64 dBA measured 1 m from front, rear, and sides of ventilator.
11-6 Operator’s Manual
Electrical Specifications
11.4
Electrical Specifications
Electrical ratings, ventilator
Mains overcurrent release
Earth leakage current
Touch current
Patient Leakage current
Table 11-5. Electrical Specifications
Electrical ratings, ventilator and compressor
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~, 50-60Hz, 8.25 A
120V~, 50-60Hz, 6.0 A
220-240V~, 50-60Hz, 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
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:
6
7
4
5
Pin
1
2
3
8
9
Table 11-6. Interface Pin Designations
Signal
N/C
RxD
TxD
N/C
GND
N/C
RTS
CTS
N/C
Name
Not connected
Receive data
Transmit data
Not connected
Ground
Not connected
Request to send
Clear to send
Not connected
The pin-out for the nurse call interface is as follows:
Operator’s Manual 11-7
Specifications
Table 11-7. Nurse Call Pin Designations
Pin
1
2
3
4
Configuration
Normally closed (NC)
Relay common
Normally open (NO)
Not connected
11.6
Environmental Specifications
The following table provides the environmental conditions appropriate for using the ventilator.
Use the ventilator only in these specified conditions:
Specification
Temperature
Atmospheric Pressure
Altitude
Table 11-8. Environmental Specifications
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
70 kPa to 106 kPa (10.15 psi to
(15.37 psi)
-411.5 m to 3048 m (-1350 ft to
10000 ft)
10% to 95% non-condensing
Storage
-20°C to 70°C (-68°F to 158°F)
50 kPa to 106 kPa (7.25 psi to 15.37 psi)
6096 m max (20000 ft max)
10 to 95% non-condensing Relative Humidity
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 •
11-8 Operator’s Manual
Performance Specifications
11.7
Performance Specifications
11.7.1
Ranges and Resolutions
settings. Reference Alarm Settings Range and Resolution , p. 11-16 for alarm settings, and
Patient Data Range and Resolution , p. 11-18 for displayed patient data parameters.
Setting
Apnea ventilation
Apnea expiratory time (T
E
)
Apnea I:E ratio
Apnea flow pattern
Apnea inspiratory pressure
(P
I
)
Apnea inspiratory time (T
I
)
Apnea interval (T
Apnea O
2
%
A
)
Table 11-9. Ventilator Settings Range and Resolution
Description
A safety mode of ventilation that starts if the patient does not receive a breath for an elapsed time exceeding 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
See individual apnea settings.
Range: 0.20
s to 59.8
Resolution: 0.01 s s
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 The flow shape of the delivered mandatory volume-based (VC) apnea breath.
The pressure above PEEP at which gas is delivered to the patient during mandatory PC apnea breaths.
Same as inspiratory time for nonapnea ventilation
Range: 5 cmH
2
O to 90-PEEP cmH
Resolution:1 cmH
2
O
The time after which the ventilator transitions to apnea ventilation
T
A
≥ 60/f
A
Determines the oxygen concentration in a standard mixture of air and oxygen.
Range: 0.20
s to 8 s
Resolution:
0.01 s in PC or VC+, 0.02 s in VC
Range: 10 s to 60
Resolution: 1 s s or OFF in CPAP
Range: 21% O
2
to 100% O
2
Resolution: 1%
2
O
Operator’s Manual 11-9
Specifications
Table 11-9. Ventilator Settings Range and Resolution (Continued)
Setting
Apnea peak inspiratory flow
( V
MAX
)
Description
The maximum rate of tidal volume delivery during mandatory volume-based apnea breaths.
Apnea respiratory rate (f
Apnea tidal volume (V
T
)
A
) Sets the number of volume- or pressure-based breaths per minute for ventilator initiated mandatory (VIM) apnea breaths.
Sets the volume of gas delivered to the patient’s lungs during a mandatory, volume-controlled apnea breath. Apnea tidal volume is compensated for body temperature and pressure, saturated
(BTPS) and the compliance of the patient circuit.
Range and resolution
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;
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
I
Apnea constant during rate change
Apnea mandatory type
Specifies which of the three operator-adjustable breath timing variables remains constant when respiratory rate is changed during apnea ventilation.
The type of mandatory breath delivered during apnea ventilation.
Circuit type
Constant during rate change
Disconnect sensitivity
(D
SENS
)
Specifies the circuit for which compliance and resistance values during SST have been calculated.
Specifies which of the three operator-adjustable breath timing variables remains constant when respiratory rate is changed.
Leak Sync disabled: The percentage of returned volume lost, above which the ventilator declares a circuit disconnect alarm.
Leak Sync enabled: The leak at
PEEP value in L/min, above which the ventilator declares a CIRCUIT
DISCONNECT alarm.
Range: PC, VC
Range: NEONATAL, PEDIATRIC, ADULT
Range: I:E ratio, T breaths; T
H
:T
L
I
, T
E
for PC or VC+
ratio, T
H
,T
L
in BiLevel
Range (Leak Sync disabled): 20% to
95% or OFF
Range (Leak Sync enabled:
NEONATAL: 1 L/min to 15 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
11-10 Operator’s Manual
Operator’s Manual
Performance Specifications
Setting
Expiratory sensitivity
(E
SENS
)
Expiratory time (T
Flow pattern
Flow sensitivity (
Gender
Height
V
E
)
Table 11-9. Ventilator Settings Range and Resolution (Continued)
SENS
)
Description
The percentage of V
MAX
that, when reached, causes the ventilator to cycle from inspiration to exhalation during spontaneous, pressure-based breaths.
For PC or VC+ breaths, the time interval between the end of inspiration and the beginning of the next inspiration. The end of the exhalation 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, determines 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
Range and resolution
Range: 1% to 80% when Spontaneous
Type is PS, or VS
1 L/min to 10 L/min when Spontaneous 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-ofinspiration.
Range: ≥ 0.20
s
Resolution: 0.01 s
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
High spontaneous inspiratory time limit ( 2 T
I SPONT
)
Active in NIV only, allows the operator to select the maximum spontaneous inspiratory time.
Reference Predicted Body Weight (PBW)
Range:
NEONATAL: 0.2
s to 1.7
s
PEDIATRIC/ADULT: 0.4 s to 5 s
Resolution: 0.1 s
Humidification type The type of humidification system used on the ventilator.
Range: HME, non-heated expiratory tube, heated expiratory tube
11-11
Specifications
Setting
Humidifier volume
Elevate O
I:E ratio
Leak Sync (leak compensation)
2
%
Inspiratory time (T
Mandatory type mL/kg ratio
I
)
Table 11-9. Ventilator Settings Range and Resolution (Continued)
Inspiratory pressure (P
I
)
Description
The empty fluid volume of the currently installed humidifier.
The percentage of O
2
to be added to the current air/O
2 mixture for two minutes.
In PC and VC+ breath types, specifies the ratio of inspiratory time to expiratory time.
Compensates for leaks during
INVASIVE or non-invasive (NIV) ventilation.
The type of mandatory breath delivered 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)
Range and resolution
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; displayed as 1:XX when I:E < 1
Range:5 cmH
2
O to 90 cmH
2
O
Resolution:1 cmH
2
O
The pressure above PEEP at which gas is delivered to the patient during mandatory PC breaths.
The time during which an inspiration is delivered to the patient during mandatory PC or VC+ breaths.
Range: 0.2
s to 8 s for mandatory PC and
VC+ breaths
T
PL
+ 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: 5.0 mL/kg to 10 mL/kg
Resolution: 0.5 mL/kg
11-12 Operator’s Manual
Operator’s Manual
Performance Specifications
Table 11-9. Ventilator Settings Range and Resolution (Continued)
Mode
Setting Description
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 initiate the breath. Applicable
SPONT breath types are pressure support (PS), volume support (VS), tube compensated (TC) or PAV+ if the PAV+ option is installed.
SIMV – Synchronized Intermittent
Mandatory Ventilation – a mixed ventilatory mode providing mandatory breaths and allowing a patient spontaneous breaths during the breath cycle.
BiLevel – a mixed ventilatory mode combining the attributes of both mandatory and spontaneous breaths incorporating two pressure levels, P
H
and P
L
.
O
2
% (delivered) Percentage of delivered oxygen in the gas mixture.
Peak inspiratory flow ( V
MAX
) The maximum rate of tidal volume delivery during mandatory volume-based breaths.
PEEP
P
P
H
L
Range and resolution
Range: A/C, SPONT, SIMV, BiLevel (if option installed but not available when vent type is NIV); CPAP (only available when circuit type is NEONATAL and vent type is NIV)
Sets the positive end-expiratory pressure, defined as the pressure targeted in the patient circuit during exhalation.
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)
Range: 0 cmH
2
O to 45 cmH
2
O
Resolution: 0.5 cmH
2
O from 0.0 cmH
2
O to 19.5 cmH
2
O; 1 cmH
2
O from 20 cmH
2
O to 45 cmH
2
O
Range: 5 cmH
2
O to 90 cmH
2
O
Resolution: 1 cmH
2
O
The positive pressure during the insufflation phase in BiLevel ventilation.
The positive pressure in the patient circuit during the expiratory phase of BiLevel ventilation.
Range: 0 cmH
2
O to 45 cmH
2
O
Resolution:
0.5 cmH
2
O from 0.0 to 19.5 cmH
2
O; 1 cmH
2
O from 20 to 45 cmH
2
O
11-13
Specifications
Table 11-9. Ventilator Settings Range and Resolution (Continued)
Setting
Plateau time (T
PL
)
Predicted Body Weight
(PBW)
Pressure sensitivity (P
SENS
)
Pressure support (P
SUPP
) or
PS
Respiratory rate (
Rise time %
% Supp f )
Spontaneous type
Description
The amount of time inspiration is held in the patient’s lungs after inspiratory flow ceases for volume-based mandatory breaths. Considered part of 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 determines default limits and limits for breath delivery parameters.
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
L
in BiLevel) during a spontaneous breath.
Sets the number of volume- or pressure-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 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 artificial airway.
Range and resolution
Range: 0 s to 2 s
Resolution: 0.1 s
Range:
NEONATAL: 0.3kg (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) to 150 kg
(330.69 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
2
O to 20.0 cmH
2
O
Resolution: 0.1 cmH
2
O
Range: 0 cmH
2
O to 70 cmH
2
O
Resolution: 1 cmH
2
O
Range:
NEONATAL:1.0 1/min to 150 1/min
PEDIATRIC/ADULT: 1.0 1/min to 100 1/ min
Resolution: 0.1 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%
Range: PS, TC, PAV+, or VS
Range: 10% to 100%
Resolution: 5%
11-14 Operator’s Manual
Operator’s Manual
Performance Specifications
Table 11-9. Ventilator Settings Range and Resolution (Continued)
% Supp
T
T
T
H
L
H
:T
L
ratio
Setting
(time high)
(time low)
Tidal volume (V
T
)
Volume support (V
T SUPP
) or
VS
Trigger type
Tube ID
Tube type
Description
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 insufflation time to expiratory time.
The volume of gas delivered to the patient during a mandatory volume-based breath. V
T
compensates for body temperature and pressure, saturated (BTPS) and circuit compliance. Applicable for volume-based breaths.
The volume of gas delivered to the patient during spontaneous, volume supported breaths.
Determines whether flow changes ( V
TRIG changes (P
TRIG breaths
)or pressure
) trigger patient
The internal diameter of the artificial airway used to ventilate the patient.
The type of artificial airway used to ventilate the patient.
Range and resolution
Range: 5% to 95%
Resolution: 5%
Range: 0.2 s to 30
Resolution: 0.01 s
Range: ≥ 0.20 s
Resolution: 0.01 s s
Range: 1:299 to 4:1; in BiLevel T
H
:T
L
Resolution: 0.01 for < 10.00:1 and >
1:10.00; 0.1for [< 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
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: V
TRIG
PEDIATRIC/ADULT: V
TRIG
or P
TRIG
Range:4.5 mm to 10 mm when spontaneous type is TC
Range: 6 mm to 10 mm when spontaneous type is PAV+
Resolution: 0.5 mm
Range: Endotracheal (ET), tracheal
(Trach
11-15
Specifications
Setting
Ventilation type
Table 11-9. Ventilator Settings Range and Resolution (Continued)
Description
Invasive or non-invasive (NIV) ventilation 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: INVASIVE, NIV
Setting
Alarm volume
Apnea interval (T
A
)
High circuit pressure setting
( 2 P
PEAK
)
Low circuit pressure setting
( 4 P
PEAK
)
High exhaled minute volume alarm setting ( 2V
E TOT
)
Table 11-10. Alarm Settings Range and Resolution
Description
Controls the volume of alarm annunciations
The
1V
E TOT
alarm indicates the measured total minute volume ≥ the set alarm limit.
Range and resolution
Range: 1 (minimum) to 10 (maximum)
Resolution: 1
Range: 10 s to 60 s or OFF in CPAP
Resolution: 1
The Apnea alarm condition indicates that neither the ventilator nor the patient has triggered a breath for the operator-selected
Apnea Interval (T
A
). When the
Apnea alarm condition is true, the ventilator invokes mandatory ventilation as specified by the operator.
The 1 P
PEAK
alarm indicates the patient’s airway pressure ≥ the set alarm level.
The 3 P
PEAK
alarm indicates the measured airway pressure ≤ the set alarm limit during an NIV or
VC+ inspiration.
Range: 7 cmH
2
O to 100 cmH
2
O
Resolution: 1 cmH
2
O
Range:
NIV: OFF or ≥ 0.5 cmH
2
O to < 100 cmH
2
O
Resolution:
0.5 cmH
2
O for values
< 20.0 cmH
2
O;
1 cmH
2
O for values
≥ 20 cmH
2
O
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 ≥ 5.0L/min
11-16 Operator’s Manual
Operator’s Manual
Performance Specifications
Table 11-10. Alarm Settings Range and Resolution (Continued)
High exhaled tidal volume alarm setting ( 2 V
TE
)
Setting
High inspired tidal volume alarm limit ( 2 V
TI
High respiratory rate alarm setting ( 2 f
TOT
)
High spontaneous inspiratory time limit ( 2 T
I SPONT
)
Low exhaled mandatory tidal volume alarm setting ( 4 V
TE MAND
)
Description
The 1 V
TE
alarm indicates that the measured exhaled tidal volume ≥ the set alarm limit for spontaneous and mandatory breaths.
The 1 V
TI
alarm indicates the delivered volume of any breath ≥ the set alarm limit.
The 1 f
TOT
alarm indicates the measured breath rate ≥ the set alarm limit.
The 1 T
I SPONT
indicator allows the operator to select the maximum spontaneous inspiratory time of an NIV breath. No alarm is annunciated; only the symbol 2 T
I SPONT appears on the screen near the
NIV indicator when inspiration time exceeds the setting. If 2 T
I
SPONT
is exceeded, the ventilator transitions from inspiration to exhalation.
The 3 V
TE MAND
alarm indicates the measured mandatory tidal volume ≤ the set alarm limit.
Range and resolution
Range: OFF and
NEONATAL: 5 mL to 500 mL
PEDIATRIC: 25 mL to 1500 mL
ADULT: 25 mL to 3000 mL
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 circuit type
Resolution: 0.1 s s
Range: OFF and
NEONATAL: 1 mL to 300 mL
PEDIATRIC: 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
11-17
Specifications
Setting
Table 11-10. Alarm Settings Range and Resolution (Continued)
Low exhaled minute volume alarm setting ( 4V
E TOT
)
Low exhaled spontaneous tidal volume alarm setting ( 4 V
TE SPONT
)
Description
The 3V
E TOT
alarm indicates the measured exhaled minute volume ≤ the set alarm limit for mandatory and spontaneous breaths.
The 3 V
TE SPONT
alarm indicates the measured spontaneous tidal volume ≤ the set alarm limit.
Range and resolution
Range: OFF when vent 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 > 5.0L/min
Range: OFF and
NEONATAL: 1 mL to 300 mL
PEDIATRIC: 1 to 1000 mL
ADULT: 1 to 2500 mL
Resolution: 1 mL for values
< 100 mL;
5 mL from 100 mL to < 400 mL; 10 mL for values ≥ 400 mL
Data value
Breath phase
Inspired tidal volume (V
Dynamic compliance
(C
DYN
)
TI
)
Inspired tidal volume (V
TL
) during Leak Sync
Table 11-11. Patient Data Range and Resolution
Description
The breath phase indicator displays the breath delivery phase
(inspiration or exhalation) currently being delivered to the patient.
The volume inspired for a pressure-based breath.
Range and resolution
Range: Control (C), Assist (A), Spontaneous (S)
The volume inspired for each breath when Leak Sync is enabled.
The result of dividing the delivered tidal volume by the peak airway pressure.
Range:0 mL to 6000 mL
Resolution:
0.1 mL for 0 mL to 9.9 mL;1 mL for values 10 mL to 6000 mL
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
2
O to 200 mL/cmH
2
O
Resolution:0.1 mL/cmH
2
O for values
< 10 mL/cmH
2
O;
1 mL/cmH
2
O for values
≥ 10 mL/cmH
2
O
11-18 Operator’s Manual
Operator’s Manual
Performance Specifications
Table 11-11. Patient Data Range and Resolution (Continued)
Dynamic resistance (R
DYN
End expiratory flow (EEF)
End expiratory pressure
(PEEP)
End inspiratory pressure
(P
I END
)
Data value
)
Description
The change in pressure per unit change in flow.
The rate of expiratory flow occurring at the end of exhalation.
The pressure at the end of the expiratory phase of the previous breath (also applies in BiLevel).
The pressure at the end of the inspiratory phase of the current breath (also applies in BiLevel).
Range and resolution
Range: 0.0 cmH
2
O/L/s to 100 cmH
2
O/L/s
Resolution:
0.1 cmH
2
O/L/ for values
< 10 cmH
2
O/L/s;
1 cmH
2
O/L/s for values
≥ 10 cmH
2
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
2
O to 130 cmH
2
O
Resolution:
0.5 cmH
2
O between
-10.0 cmH
2
O and +10.0 cmH
2
O; 1 cmH
2
O for values ≤ -10 cmH
2
O and
≥ 10 cmH
2
O
Range:
-20.0 cmH
2
O to 130 cmH
2
O
Resolution:
0.1 cmH
2
O for -20.0 cmH
2
O to 9.9 cmH
2
O;
1.0cmH
2
O for values
10 cmH
2
O to 130 cmH
2
O
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
Exhaled mandatory tidal volume (V
SPONT
)
TE MAND
)
Exhaled minute volume ( V
E
TOT
)
Exhaled spontaneous minute volume ( V CO
2
Exhaled spontaneous tidal volume (V
TE SPONT
)
V
E
The exhaled volume of the last mandatory 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 manual inspiration.
A calculated sum of the volumes exhaled by the patient for mandatory and spontaneous breaths for the previous one-minute interval
(also applies in BiLevel).
The sum of exhaled spontaneous volumes per minute (also applies in BiLevel).
The exhaled volume of the last spontaneous breath.
Range: 0.00 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 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: 0.1mL for 0 mL to 9.9 mL;
1 mL for 10 mL to 6000 mL
11-19
Specifications
Leak Sync exhaled tidal volume (V
TE
I:E ratio
Mean circuit pressure
(P
MEAN
)
)
Inspiratory compliance
(C
20
Negative inspiratory force
(NIF)
/C)
Intrinsic PEEP (PEEP
O
P
2
% (monitored)
0.1
I
)
Table 11-11. Patient Data Range and Resolution (Continued)
Data value
Exhaled tidal volume (V
TE
)
Description
The volume exhaled by the patient for the previous mandatory or spontaneous breath (also applies in BiLevel).
The volume exhaled by the patient for the previous mandatory or spontaneous breath during
Leak Sync (also applies in BiLevel).
The ratio of the inspiratory time to expiratory time for the previous breath.
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: 0 mL to 6000 mL
Resolution:
0.1mL for 0 mL to 9.9 mL;
1 mL for 10 mL to 6000 mL
Range: 0 mL to 6000 mL
Resolution:
0.1mL 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
The calculated average circuit pressure for an entire breath cycle including both inspiratory and expiratory phases (whether the breath is mandatory or spontaneous).
The negative pressure generated during a maximally forced inspiratory effort against an obstruction to flow.
Range:
-20.0 cmH
2
O to +130 cmH
2
O
Resolution:
0.1 cmH
2
O between
-9.9 and +9.9 cmH
2
O;
1 cmH
2
O ≤ -10 cmH
2
O and ≥
10 cmH
2
O
Range:
-20.0 cmH
2
O to 100 cmH
2
O
Resolution:
0.1 cmH
2
O for -20.0 to 9.9 cmH
2
O;
1 cmH
2
O for 10 to 100 cmH
2
O
Range: ≤ 0 cmH
2
O to ≥ -50 cmH
2
O
Resolution: 1 cmH
2
O for values
≤ -10 cmH
2
O;
0.1 cmH
2
O for values
> -10 cmH
2
O
Range: 0% to 103%
Resolution: 1%
The monitored percentage of oxygen in the gas delivered to the patient, measured at the ventilator outlet upstream of the inspiratory filter.
The inspiratory depression of airway pressure after 100 ms of occlusion. P
0.1
measures respiratory drive.
Range: ≥ -20 cmH
Resolution:
1 cmH
2
O to 0 cmH
2
2
O when < -10 cmH
2
O;
0.1 cmH
2
O when ≥ -10 cmH
2
O
O
11-20 Operator’s Manual
Operator’s Manual
Performance Specifications
PAV-based lung compliance (C
PAV
PAV-based lung elastance
(E
PAV
)
1
)
1
PAV-based patient resistance (R
PAV
)
1
Table 11-11. Patient Data Range and Resolution (Continued)
Data value
PAV based intrinsic PEEP
(PEEP
I PAV
)
Description
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 measured under conditions of zero flow during a PAV+ plateau maneuver. When PAV+ is selected, the ventilator 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. Reference
For a PAV+ breath, E
PAV
is calculated as the inverse of C
PAV
(see above). E
PAV
can be displayed in
the vital patient data banner. Reference Vital Patient Data , p. 3-35.
Range and resolution
Range: 0 to 130 cmH
2
O
Resolution: 0.1 cmH
2
O for values <
10 cmH
2
O; 1 cmH
2
O for values
≥ 10 cmH
2
O
Range: 2.5 mL/cmH cmH
2
1 cmH
O
< 10 mL/cmH
2
≥ 10 mL/cmH
2
2
O;
O for values
O
2
O to 200 mL/
Resolution: 0.1 mL/cmH
2
O for values
The difference between estimated total resistance R
TOT
and the simultaneously 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 estimation. R
PAV
can be displayed in
the vital patient data banner. Reference Vital Patient Data , p. 3-35.
Range: 5.0 cmH
2
O/L to 400 cmH
2
O/
L
Resolution: 0.1 cmH
2
O/L for values <
10 cmH
2
O/L;
1 cmH
2
O/L ≥ 10 cmH
2
O/L
Range:
0.0 cmH
2
O/L/s to 60 cmH
2
O/L/s
Resolution:
0.1 cmH
2
O/L/s for values
< 10 cmH
2
O/L/s;
1cmH
2
O/L/s for values
≥ 10 cmH
2
O/L/s
11-21
Specifications
Table 11-11. Patient Data Range and Resolution (Continued)
Data value
PAV-based total airway resistance (R
TOT
)
1
PAV-based work of breathing (WOB
TOT
)
Peak expiratory flow (PEF)
Description
R
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 expiratory flow estimated at the same moment, yielding the estimate for R
TOT
.The complete operation is orchestrated and monitored by a software algorithm. When PAV+ is selected, the ventilator displays the current filtered value for total resistance, and updates the display at the successful completion of each calculation. R
TOT
can be displayed in the vital patient
The estimated effort needed for patient inspiration including both patient and ventilator.
The maximum speed of exhalation.
Range and resolution
Range: 1.0 cmH
2
O/L/s to 80 cmH
2
O/
L/s
Resolution:
0.1 cmH
2
O/L/s for values
< 10 cmH
2
O/L/s; 1 cmH
2
O/L/s for values ≥ 10 cmH
2
O/L/s
Range: 1.0 J/L to10.0 J/L
Resolution: 0.1 J/L
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)
Plateau pressure (P
PL
)
The maximum flow rate sampled during a spontaneous inspiration.
The pressure measured during an inspiratory pause maneuver.
Range:
-20.0 cmH
2
O to 130 cmH
2
O
Resolution:
0.1 cmH
2
O for values
-20.0 to 9.9 cmH
2
O;
1.0 cmH
2
O for values
10 cmH
2
O to 130 cmH
2
O
Range:0 to 200 L/min
Resolution:
0.1 L/min for values
< 20 L/min;
1L/min for values ≥ 20 L/min
Range:
-20.0 cmH
2
O to 130 cmH
2
O
Resolution:
0.1 cmH
2
O for values
-20.0 to 9.9 cmH
2
O;
1.0 cmH
2
O for values ≥ 10 cmH
2
O
11-22 Operator’s Manual
Operator’s Manual
Performance Specifications
Table 11-11. Patient Data Range and Resolution (Continued)
Data value
Proximal exhaled tidal volume (V
TEY
)
Proximal exhaled total minute volume ( V
E TOTY
Proximal inspired tidal volume (V
TIY
)
Spontaneous inspiratory time (T
I SPONT
)
Spontaneous inspiratory time ratio
(T
I
/T
TOT
)
Spontaneous rapid shallow breathing index (f/V
T
)
The fraction of the total spontaneous breath time used by inspiration.
Static compliance (C
Resistance (R
STAT
Total PEEP (PEEP
L
)
)
STAT
)
)
Description
For neonatal patients, the exhaled volume of the previous breath measured by the Proximal Flow
Sensor) (if installed).
For neonatal patients, the exhaled minute volume measured by the
Proximal Flow Sensor).
Range and resolution
Range: 0 mL to 500 mL
Resolution: 0.1mL for values 0 mL to 9.9 mL; 1 mL for values
10 mL to 500 mL
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 to 99.9 L/min
Range: 0 mL to 500 mL
Resolution: 1 mL
For neonatal patients, the exhaled volume of the previous breath measured by the Proximal Flow
Sensor) (if installed).
The duration of the inspiratory phase of a spontaneous breath.
Range: 0 s to 10 s
Resolution: 0.01 s
Range: 0 to 1
Resolution: 0.01
A calculated value using exhaled spontaneous tidal volume. High values indicate the patient is breathing rapidly, but with little volume/breath. Low values indicate the inverse scenario.
An estimate of the patient’s lungthorax static compliance or elasticity.
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
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.
Range:
0 mL/cmH
2
O to 500 mL/cmH
2
O
Resolution:
0.1 mL/cmH
2
O for values
< 10 mL/; 1 mL/cmH
2
O for values ≥
10 mL/cmH
2
O
Range:
0 cmH
2
O/L/s to 500 cmH
2
O /L/s
Resolution:
0.1 cmH
2
O/L/s for values
< 10 cmH
2
O/L/s;
1 cmH
2
O/L/s for values
≥ 10 cmH
2
O/L/s
Range:
-20.0 cmH
2
O to +130 cmH
2
O
Resolution:
0.1 cmH
2
O for values
< 10 cmH
2
O;
1 cmH
2
O for values
≤ -10 cmH
2
O and ≥ 10 cmH
2
O
11-23
Specifications
Table 11-11. Patient Data Range and Resolution (Continued)
Data value
Total respiratory rate (f
TOT
Vital capacity (VC)
)
Description
The number of mandatory or spontaneous breaths/min delivered to the patient.
The maximum amount of air that can be exhaled after a maximum inhalation.
Range and resolution
Range: 1 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 values ≥ 10 mL
Range: 0 to 9000 mL
Resolution: 1 mL
V
LEAK
%LEAK
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) x 100.
Range: 0 to 100%
Resolution: 1%
LEAK
LEAK
Y
Exhalation leak.The leak rate at
PEEP during exhalation.
Exhalation Leak at PEEP during
Leak Sync measured by the proximal flow sensor.
Range: 0 to 200 L/min
Resolution: 0.1 L/min
Range: 0 to 200 L/min
Resolution: 0.1 L/min
1.
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.
11-24 Operator’s Manual
Operator’s Manual
Performance Specifications
Parameter
Inspiratory pressure (P
I
)
End expiratory pressure (PEEP)
Pressure support (P
SUPP
Tidal volume (V
T
)
O
P
P
2
H
L
% (delivered)
Table 11-12. Delivery Accuracy
Accuracy
± (3.0+2.5% of setting) cmH
2
O
± (2.0+4% of setting) cmH
2
O
± (3.0+2.5% of setting) cmH
2
O
For adult and pediatric circuit type settings:
For T
I
< 600ms: ± (10 + 10% of setting x 600 ms/T
I
ms) mL
For T
I
≥ 600 ms
± (10 + 10% of setting) 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 volume 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%
Range
5 cmH
2
O to 90 cmH
2
O
0 cmH
2
O to 45 cmH
2
O
0 cmH
2
O to 70 cmH
2
O
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%
± (2.0 + 4% of setting) cmH
2
O
± (2.0 + 4% of setting) cmH
2
O
5 cmH
2
O to 90 cmH
2
O
0 cmH
2
O to 45 cmH
2
O
Table 11-13. 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
TI
)
Exhaled tidal volume (V
TE
)
Accuracy
± (2 + 4% of reading) cmH
2
O
± (2 + 4% of reading) cmH
2
O
± (2 + 4% of reading) cmH
2
O
± (2 + 4% of reading) cmH
2
O
± (4mL + 15% of actual) mL
± (4mL + 10% of actual) mL
Range
5 cmH
2
O to 90 cmH
2
O
3 cmH
2
O to 70 cmH
2
O
0 cmH
2
O to 45 cmH
2
O
5 cmH
2
O to 90 cmH
2
O
2 mL to 2500 mL
2 mL to 2500 mL
11-25
Specifications
Table 11-13. Monitoring (Patient Data) Accuracy (Continued)
Parameter
Inspired tidal volume during Leak
Sync
Exhaled tidal volume (V
TE
) during
Leak Sync
Accuracy
For adult and pediatric circuit type settings:
For T
I
≤ 600ms: ± (10 + 20% x 600 ms/T
I
ms of reading) mL
For T
I
> 600 ms: (10 + 20% of reading) 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%
For adult and pediatric circuit type settings:
For T
E
≤ 600 ms: ± (10 + 20% x 600 ms/T
E ms of reading) mL
For T
E
> 600 ms: ± (10 + 20% of reading) mL
For neonatal circuit type settings:
± (10+20% of reading) mL
For readings < 100 mL, the accuracy shall apply when the percentage of inspiratory leak volume is less than 80%
± (1 + 10% of reading) mL
Range
For adult and pediatric circuit type settings:
25 mL to 2500 mL
For neonatal circuit type settings:
2 mL to 310 mL
For adult and pediatric circuit type settings:
25 mL to 2500 mL
For neonatal circuit type settings:
2 mL to 310 mL
2 mL to 310 mL Proximal exhaled tidal volume
(V
TEY
)
Proximal inspired tidal volume
(V
TIY
)
O
2
% (monitored)
Respiratory Rate ( f )
± (1 + 10% of reading) mL
± 3%
± 0.8 1/min
2 mL to 310 mL
15% to 100%
1 1/min to 150 1/min
11-26 Operator’s Manual
Regulatory Compliance
Table 11-14. Computed Value Accuracy
Parameter
PAV-based lung compliance
(C
PAV
)
PAV based total airway resistance
(R
TOT
)
PAV based work of breathing
(WOB
TOT
)
Accuracy
± (1+20% of measured value) mL/ cmH
2
O
± (3 + 20% of measured) cmH
2
O/
L/s
± (0.5 + 10% of measured work) J/
L with a percent support setting of 75%
Range
10 to 100 mL/cmH
2
O
5.0 to 50 cmH
2
O/L/s
0.7 J/L to 4 J/L
WARNING:
The ventilator accuracies listed in this chapter are applicable under the operating conditions
identified in the table, Environmental Specifications on page 11-8 .
Operation outside specified ranges cannot guarantee the accuracies listed in the tables above, 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
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
Operator’s Manual 11-27
Specifications
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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
11-28 Operator’s Manual
Manufacturer’s Declaration
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 inches) 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.
Operator’s Manual 11-29
Specifications
Table 11-15. Electromagnetic Emissions
The ventilator is intended for use in the electromagnetic environment specified below. The customer of the operator of the ventilator should assure that it is used in such an environment.
Emissions Test Compliance
Radiated RF emissions
CISPR 11
Group 1
Class A
Electromagnetic environment – guidance
The ventilator uses RF energy only for its internal functions.
The ventilator is intended to be used only in hospitals and not be connected to the public mains network.
Conducted emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker
IEC 61000-3-3
Class A
Complies
The ventilator 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 network.
Table 11-16. Electromagnetic Immunity
Test standard Test levels Remarks EMC test
ESD
IEC 60601-1-2,
Edition 3.0:2007
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-2
±2,4,6,8 kV contact discharge
±2,4,8, 15kV air discharge
Radiated immunity
IEC 60601-1-2,
Edition 3.0:2007
IEC 61000-4-3
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-3
10 V/m
3 V/m
N/A
Modulation: 80%
AM, 2 Hz
Modulation: 80%
AM, 1 kHz
Electromagnetic environment— guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least
30%.
N/A
11-30 Operator’s Manual
Operator’s Manual
Manufacturer’s Declaration
Table 11-16. Electromagnetic Immunity (Continued)
Test standard Test levels Remarks EMC test Electromagnetic environment— guidance
EFT burst
Surge
IEC 60601-1-2,
Edition 3.0:2007
IEC 61000-4-4
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-4
IEC 60601-1-2,
Edition 3.0:2007
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-5
IEC 60601-1-2,
Edition 3.0:2007
IEC 61000-4-6
±1 kV (I/O)
±2 kV (AC Mains)
±0.5 kV, 1 kV line to line
±0.5 kV, 1 kV & 2 kV line to earth
Conducted immunity
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-6
3 V RMS
10 V RMS in the following frequency ranges (ISM
Bands
1
);
• 6.765–6.795 MHz
• 13.553–13.567
MHz
• 26.957–27.283
MHz
• 40.66–40.70 MHz
3 V RMS
6 V RMS in the following frequency ranges (ISM
Bands
1
);
• 6.765–6.795 MHz
• 13.553–13.567
MHz
• 26.957–27.283
MHz
• 40.66– 40.70 MHz
Magnetic immunity
IEC 60601-1-2,
Edition 3.0:2007
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-8
30 A/m
NOTE: U
T
is the AC mains voltage prior to application of the test level.
5 kHz pulse repetition rate
100 kHz pulse repetition rate
Mains power quality should be that of a typical hospital environment.
N/A
Modulation:
80%AM, 2 Hz
Modulation: 80%
AM, 1 kHz
N/A
Portable and mobile RF communications equipment should be used no closer to any part of the ventilator system, including cables, than the separation distance calculated from the equation applicable to the frequency of the transmitter. See
Power frequency magnetic fields should be at levels characteristic of a typical hospital environment.
11-31
Specifications
Table 11-16. Electromagnetic Immunity (Continued)
EMC test Test standard Test levels Remarks Electromagnetic environment— guidance
Voltage dips
IEC 60601-1-2,
Edition 3.0:2007
IEC 61000-4-11
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-11
• 95% minimum voltage reduction for 0.5 periods (10 ms)
• 60% minimum voltage reduction for 5 periods (100 ms)
• 30% minimum voltage reduction for 25 periods (500 ms)
• U
T
=0%, 0.5 cycle
(0, 45, 90, 135, 180,
225, 270, and 350°)
• U
T
=0%; 1 cycle
• U
T
=70%; 25/30 cycles (@0°)
N/A
Mains power should be that of a typical hospital environment. If the operator of the ventilator requires continuous operation during power mains interruptions, it is recommended that the ventilator be powered from an uninterruptible power supply or a battery.
Interrupts
IEC 60601-1-2,
Edition 3.0:2007
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-11
• U
T
=0%; 250/300 cycles
Proximity field from
RF wireless communication equipment
RFID immunity
IEC 60601-1-2,
Edition 4.0:2014
IEC 61000-4-3
AIM Standard
7351731 Rev. 2.00
2017
IEC 61000-4-3
See
Wireless Communications Equipment
).
Modulation: See
Immunity to Proximity Fields RF Wireless
).
See section 7 in AIM
Standard 7351731 for more details on execution of the different RFID specifications.
N/A
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.
1.
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 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.
11-32 Operator’s Manual
Operator’s Manual
Manufacturer’s Declaration
Test frequency
(MHz)
385
450
Table 11-17. Immunity to Proximity Fields RF Wireless Communications Equipment
Band
(MHz)
Service
TETRA 400
Modulation Maximu m power
(W)
1,8
Distance (m)
0,3
380–390
430–470
• GMRS 460
• FRS 4 60
Pulse modulation
18 Hz
FM
±5 kHz deviation
1 kHz sine
2 0,3
710
745
780
810
870
704–787
800–960
LTE Band 13, 17
Pulse modulation
217 Hz
0,2
2
0,3
0,3
930
1720
1845
1970
2450
1700–1990
2400–2570
• GSM 800/900
• TETRA 800
• iDEN 820
• CDMA 850
• LTE Band 5
• GSM 1800
• CDMA 1900
• GSM 1900
• GSM 1900 DECT
• LTE Band 1, 3, 4, 25
• UMTS
• Bluetooth
• WLAN, 802.11 b/g/ n
• RFID 2450
• LTE Band 7
Pulse modulation
18 Hz
Pulse modulation
217 Hz
Pulse modulation
217 Hz
2
2
0,3
0,3
5240
5500
5785
5100–5800 WLAN 802.11a/n
Pulse modulation
217 Hz
0,2 0,3
Immunity test level
(V/m)
27
28
9
28
28
28
9
11-33
Specifications
Table 11-18. 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
13.56 MHz
13.56 MHz
13.56 MHz
433 MHz
860–960 MHz
2.45 GHz
Test level (RMS)
65 A/m
7.5 A/m
7.5 A/m
5 A/m
12 A/m
3 V/m
54 V/m
54 V/m
Table 11-19. Recommended Separation Distances for RF
0.01
0.1
1
10
100
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 interference by maintaining a minimum distance between portable and mobile RF communications equipment (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 d = 1.17
P
150 kHz to 80 MHz inside of ISM bands d = 1.2
P
80MHz to 800 MHz d = 1.2
P
800 MHz to 2.5 GHz d = 2.3
P
0.117
0.37
1.17
3.7
11.7
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
11-34 Operator’s Manual
Manufacturer’s Declaration
Table 11-19. Recommended Separation Distances for RF (Continued)
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 interference by maintaining a minimum distance between portable and mobile RF communications equipment (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 d outside of ISM
= bands
1.17
P
150 kHz to 80 MHz inside of ISM bands d = 1.2
P
80MHz to 800 MHz d = 1.2
P
800 MHz to 2.5 GHz d = 2.3
P
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
1
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
2
, should be less than the compliance level in each frequency range
3
. Interference may occur in the vicinity of equipment marked with the following symbol:
1.
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.
2.
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.
3.
. 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.
Operator’s Manual 11-35
Specifications
Table 11-20. 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)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
10 ft (3 m)
Cable length
11.10
Safety Tests
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 alarms and gas failure alarms, are identified
. AC and battery backup power information is given in Chapter 3
, and gas failure cross
flow information is given in Chapter 3 .
11-36 Operator’s Manual
Essential Performance Requirements
•
•
•
•
•
•
•
•
•
If essential performance is lost or degraded due to exposure of electromagnetic disturbance
levels higher than those described in Table 11-16.
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
Operator’s Manual 11-37
Specifications
Page Left Intentionally Blank
11-38 Operator’s Manual
A BiLevel 2.0
A.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 A-1. Spontaneous Breathing at P
L
1
2
3
P
CIRC
(cmH
2
O)
T
H
T
L
4
5
6
P
H
P
L
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.
A-1
BiLevel 2.0
Figure A-2. BiLevel Mode
A-2
1
2
3
4
Pressure (y-axis)
P
L
P
H
Spontaneous breath
5
6
7
Synchronized transitions
Pressure support
Time-based transitions
The two pressure levels are called Low Pressure (P
L
) and High Pressure (P
H
). At either pressure level, patients can breathe spontaneously, and spontaneous breaths can be assisted with tube compensation or pressure support. BiLevel monitors mandatory and spontaneous tidal volumes separately.
Inspiratory time and expiratory time in BiLevel become Time high (T
H
) and Time low (T
L
), respectively. During these inspiratory and expiratory times, P
H
is maintained during T
H
and P
L
is maintained during T
L
.
A.2
Intended Use
BiLevel is intended for adult, pediatric, and neonatal patients.
A.3
Safety Symbol Definitions
This section contains safety information for users, who should always exercise appropriate caution while using the ventilator.
Symbol
Table A-1. Safety Symbol Definitions
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.
Operator’s Manual
Setting Up BiLevel
Symbol
Table A-1. Safety Symbol Definitions
Definition
Note
Notes provide additional guidelines or 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.
A.4
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.
4.
Choose the spontaneous type (PS or TC).
Choose trigger type (P
TRIG
or
V
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
H
must always be at least 5 cmH
2
O greater than P
L
.
6.
Set T
L
, T
H
, or the ratio of T
H
to T
L
. To select settings that would result in a T
H
:T
L
ratio greater than 1:1 or
4:1, you must touch Continue to confirm after reaching the 1:1 and 4:1 limits.
Operator’s Manual A-3
BiLevel 2.0
Figure A-3. BiLevel Setup Screen
A-4
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
L
to P
H
and for spontaneous breaths, even when pressure support (P
SUPP
) = 0. Expiratory sensitivity (E
SENS
applies to all spontaneous breaths.
A.5
Using Pressure Support with BiLevel
•
•
•
•
Spontaneous breaths in BiLevel mode can be assisted with pressure support according to these
rules (Reference BiLevel with Pressure Support , p. A-5):
Pressure support (P
SUPP
) can be used to assist spontaneous breaths at P
L
and P
H
. P
SUPP
is always set relative to P
L
. Target pressure = P
L
+ P
SUPP
.
Spontaneous patient efforts at P
H
are not pressure supported unless P
SUPP
> (P
H
- P
L
). All spontaneous breaths (whether or not they are pressure supported) are assisted by a pressure of 1.5 cmH
2
O.
If P
SUPP
+ P
L
is greater than P
H
+ 1.5 cmH
2
O, all spontaneous breaths at P
L
are assisted by the P
SUPP setting, and all spontaneous breaths at P
H
are assisted by P
SUPP
- (P
H
- P
L
).
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
2
O.
Operator’s Manual
Manual Inspirations in BiLevel Mode
•
•
For example, if P
L
= 5 cmH
2
O, P
H
= 15 cmH
2
O, and P
SUPP
= 20 cmH
2
O:
All spontaneous breaths at P
L
are assisted by 20 cmH
2
O of pressure support (P
L
+ P
SUPP
) for a total pressure of 25 cmH
2
O, and
All spontaneous breaths in P
H
are assisted by 10 cmH
2
O of pressure support
(P
SUPP
- (P
H
- P
L
)) for the same total pressure of 25 cmH
2
O.
Figure A-4. BiLevel with Pressure Support
1
2
3
Pressure (y-axis)
P
H
Pressure support = 10 cmH
2
O
P
L
Pressure support = 20 cmH
2
O
4
5
P
H
P
L
During spontaneous breaths, the pressure target is calculated with respect to P
L
.
A.6
Manual Inspirations in BiLevel Mode
•
Pressing the MANUAL INSP key during BiLevel mode causes the ventilator to:
Cycle to P
H
, if the current pressure level is P
L
.
• Cycle to P
L
, If the current pressure level is P
H
.
To avoid breath stacking, the ventilator does not cycle from one pressure level to another during the earliest stage of exhalation.
A.7
Respiratory Mechanics Maneuvers in BiLevel
In BiLevel, respiratory mechanics maneuvers are limited to inspiratory pause and expiratory pause maneuvers.
Operator’s Manual A-5
BiLevel 2.0
A.8
Specifications
•
•
•
•
•
•
•
Reference the table,
Ventilator Settings Range and Resolution , in
Chapter 11 of this manual for the
following specifications:
Low pressure (P
L
)
High pressure (P
H
)
Low pressure time (T
L
)
High pressure time (T
H
)
T
H
:T
L
ratio
Respiratory rate ( f )
Rise time %
A.9
Technical Description
BiLevel is a mode of ventilation that alternately cycles between two operator-set pressure levels,
P
L and P
H
. The pressure durations are defined by operator-set timing variables T
L and T
H
. Transitions between the two pressure levels, P
L
and P
H
, are analogous to breath phase transitions in PC.
At the extreme ranges of T
L
and T
H
, BiLevel can resemble the single breath type mode A/C - PC, or the more complex breath type mode, an “inverted-like” IMV. If T
H
and T
L
assume “normal” values with respect to PBW (for example T
H
:T
L
> 1:2 or 1:3), then BiLevel assumes a breathing pattern similar to, if not qualitatively identical to A/C - PC. However, as T
L
begins to shorten with the T
H
:T
L
ratio extending beyond 4:1, the breathing pattern assumes a distinctly different shape.
In the extreme, the exaggerated time at P
H
and abrupt release to P
L
would match the pattern patented by John Downs
*
and defined as APRV.
In between the A/C-PC-like pattern and the APRV-like pattern, there would be patterns with moderately long T
H
and T
L
intervals, allowing the patient sufficient time to breathe spontaneously at both P
H
and P
L
In these types of breathing patterns, (but less so with APRV) BiLevel, like SIMV, can be thought of as providing both mandatory and spontaneous breath types. In this sense, BiLevel and SIMV are classified as mixed modes.
Direct access to any of the three breath timing parameters in BiLevel is accomplished by touching the Padlock icon associated with the T
H
period, T
L
period or the T
H
:T
L
ratio displayed on the breath timing bar in the setup screen.
*.
Downs, JB, Stock MC. Airway pressure release ventilation: A new concept in ventilatory support. Crit Care Med 1987;15:459-461
A-6 Operator’s Manual
Technical Description
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.
A.9.1
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
to be extended to prevent transitions to P
L
during the patient's spontaneous inspiration. Likewise, the T
L
interval may be extended to prevent a transition to P
H
during the patient's spontaneous exhalation.
The trigger sensitivity setting (P
SENS
or V
SENS
) is used to synchronize the transition from P
L
to P
H
.
The transition from P
H
down to P
L
is synchronized with the patient's spontaneous expiratory effort. The BiLevel algorithm will vary the T
L
and T
H
intervals as necessary to synchronize the transitions between P
L
and P
H
to match the patient's breathing pattern.
The actual durations of T
H
and T
L
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
H and T
L
periods into spontaneous and synchronous intervals as shown in the figure below.
Figure A-5. Spontaneous and Synchronous Intervals
3
4
1
2
Pressure (y-axis)
T
H
P
H
P
L
5
6
7
T
L
Synchronous interval
Spontaneous interval
By partitioningT
H
and T
L
into spontaneous and synchronous phases, BiLevel responds to patient efforts (or lack of them) in a predictable pattern:
Operator’s Manual A-7
BiLevel 2.0
•
•
•
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
to
P
H
. If there is no spontaneous (patient) effort, this transition takes place at the end of the T
L
period.
During T
H synchronous intervals, successful expiratory efforts cause the ventilator to cycle from P
H
to
P
L
. If there is no spontaneous exhalation, the transition to the P
L
level takes place at the end of the T
H period.
A.9.2
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.
A.9.3
APRV Strategy in BiLevel
Lengthening the T
H
period and shortening the T
L
period to only allow incomplete exhalation of the mandatory breath volume, results in an inverse T
H
:T
L
ratio. In this breath timing configuration with T
H
:T
L
ratios of greater than 4:1, BiLevel becomes A irway P ressure R elease V entilation (APRV).
APRV is characterized as longer T
H
periods, short T
L
periods (usually less than one second), and inverse T
H
:T
L
ratios. Since, at these breath timing settings, all of the patient-triggered spontaneous breaths occur during the T
H
period, APRV resembles CPAP ventilation with occasional, short periods of incomplete exhalation referred to as “releases“ which are controlled by the f setting.
Figure A-6. APRV With Spontaneous Breathing at P
H
A-8
1
2
P
CIRC
(cmH
2
O)
Lengthened inspiratory time (T
H
)
3 Shortened release time (T
L
)
Operator’s Manual
Mode Changes
In APRV, the P
H
level is set to optimize pulmonary compliance for spontaneous breathing while maintaining an elevated mean airway pressure to promote oxygenation, theP
L
level is set, along with the T
L
, to control the expiratory release volume of mandatory breaths to help manage CO
2 and alveolar ventilation, and the f setting controls the number of releases per minute which are used to help manage the patient's CO
2
levels. The f setting also impacts the mean airway pressure.
In APRV the operator can configure the BiLevel settings to allow direct control of T
L
to assure that changes in the f setting will not inadvertently lengthen the T
L
period resulting in destabilization of end-expiratory alveolar volume. With the T
L
period locked, changes in set f will change the T
H period to accommodate the new f setting while maintaining the set T
L
period.
A.9.4
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 T
H
. Both pressure levels permit CPAP, TC and PS breaths. The breath timing settings determine whether the patient can initiate any of these breath types.
A.10
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.
Operator’s Manual A-9
BiLevel 2.0
Page Left Intentionally Blank
A-10 Operator’s Manual
B Leak Sync
B.1
Overview
This appendix describes the operation of the Puritan Bennett™ 980 Series Ventilator Leak Sync option. The Leak Sync option 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 synchro-
in this manual for general parameter and operational information.
B.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.
B.3
Safety Symbol Definitions
This section contains safety information for users, who should always exercise appropriate caution while using the ventilator.
Symbol
Table B-1. Safety Symbol Definitions
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.
B-1
B-2
Leak Sync
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.
B.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.
The following table shows the maximum leak rates at set PEEP pressure that Leak Sync will compensate based on patient type.
Table B-2. Maximum Leak Compensation Flow Based on Patient Type
Neonatal
Pediatric
Adult
Patient type Maximum Leak compensation flow at
PEEP
15 L/min
40 L/min (25 L/min if the compressor is the air source)
65 L/min (25 L/min if the compressor 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.
Operator’s Manual
Setting Up Leak Sync
B.5
Setting Up Leak Sync
For more information on setting up the ventilator, reference
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 B-1. Enabling Leak Sync
Note:
The default value for Leak Sync is Disabled when the circuit type is Pediatric or Adult and the Vent 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.
B.6
When Leak Sync is Enabled
•
•
Reference GUI Screen when Leak Sync is Enabled , p. B-4 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 %.
Operator’s Manual B-3
Leak Sync
•
•
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 (
V
SENS
).
Note:
The absence of the Leak Detected message does not mean there is no leak.
Note:
Leak Sync is automatically enabled when Vent Type is NIV or if New patient is selected and circuit type is neonatal, regardless of the Vent Type. If Leak Sync is disabled while the Vent Type is invasive but the Vent
Type is changed to NIV, it remains disabled. Leak Sync becomes disabled when Vent Type is set to INVASIVE and circuit type is Adult or Pediatric.
Figure B-2. GUI Screen when Leak Sync is Enabled
B-4
1 LS appears on Vent Setup button notifying the operator that Leak Sync is enabled
B.6.1
Adjusting Disconnect Sensitivity (D
SENS
)
When Leak Sync is enabled, the Circuit Disconnect alarm becomes active based on the D
SENS
setting, which is the maximum allowable leak rate at set PEEP.
Operator’s Manual
When Leak Sync is Enabled
When Leak Sync is disabled, D
SENS
is automatically set to 75%.
WARNING:
When Vent Type = NIV and Leak Sync is disabled, D
SENS
is automatically set to OFF.
Reference the table below for a summary of D
SENS
settings when Leak Sync is enabled. Note that it is possible to set D
SENS
below maximum Leak Sync flow.
Breathing circuit type
Neonatal
Pediatric
Adult
Table B-3. D
SENS
Settings
D
SENS
setting
Range: 1 L/min to 15 L/min
Default: 2 L/min (INVASIVE ventilation) 5 L/min (NIV)
Range: 1 to 40 L/min
Default: 20 L/min
Range: 1 to 65 L/min
Default: 40 L/min
Maximum total flow
50 L/min
120 L/min
200 L/min
WARNING:
Setting D
SENS
higher than necessary may prevent timely detection of inadvertent extubation.
B.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.
Operator’s Manual B-5
Leak Sync
Figure B-3. Leak Sync Monitored Patient Data
B-6
1 Leak Sync Parameters
•
•
•
Reference the table
Patient Data Range and Resolution
in Chapter 11 of this manual for information
regarding the following monitored patient data parameters:
V
LEAK
% LEAK
LEAK
Displayed values for Exhaled Tidal Volume (V
TE
) and Inspired Tidal Volume (V
TL
) are leak-compensated, and indicate the estimated inspired or exhaled lung volume. The accuracies for V
TE
and V
TL also change when Leak Sync is enabled (see Technical Discussion for more information). Graphic displays of flow during Leak Sync indicate estimated lung flows.
B.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
Operator’s Manual
Technical Discussion
• 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.
•
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.
B.7.1
Inspired Tidal Volume (V
TL
) Accuracy During Leak Sync
Reference Patient Data Range and Resolution , p. 11-18, V
TL
parameter, for V
TL
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) x 100
Note:
Inspired tidal volume is labeled as V
TL
when Leak Sync is enabled, and as V
TI
when Leak Sync is disabled.
B.7.2
Exhaled Tidal Volume (V
TE
) Accuracy During Leak Sync
Reference Patient Data Range and Resolution , p. 11-18, V
TE
parameter, for accuracy when Leak Sync is enabled.
where T
E
= 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) x 100
B.7.3
%LEAK Calculation
Reference Patient Data Range and Resolution , p. 11-18, % LEAK parameter, for specifications.
B.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
SENS
setting. During VC, the Circuit Disconnect alarm is also activated if the end-inspiratory pressure falls below (set PEEP + 1 cmH
2
O) for three consecutive breaths. The screen shows this alarm message:
Operator’s Manual B-7
Leak Sync
Figure B-4. 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.
B-8 Operator’s Manual
C PAV™+
C.1
Overview
This appendix describes the operation of the PAV™
*
+ software option for the Puritan Bennett™
980 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.
C.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.
C.3
Safety Symbol Definitions
This section contains safety information for users, who should always exercise appropriate caution while using the ventilator.
*.
Proportional Assist and PAV are registered trademarks of The University of Manitoba, Canada. Used under license.
C-1
PAV™+
Symbol
Table C-1. Safety Symbol Definitions
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.
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 overassist 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.
C.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 the PAV+ option and the accuracy of resistance (R) and elastance (E) estimates.
C-2 Operator’s Manual
PAV+
WARNING:
Do not use silicone breathing circuits with the PAV+ option: 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 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 five (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 reestimate patient resistance and compliance. New values are always averaged with former values.
The PAV+ option 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.
Operator’s Manual C-3
PAV™+
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.
The PAV+ option also includes alarm limits, safety checks, and logic checks that reject non-physiologic values for patient resistance and compliance as well as inappropriate data.
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 rerunning SST. For optimal breath delivery, run SST after changing humidification type and humidifier volume.
C.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 vent type.
3.
Touch SPONT mode.
4.
5.
Touch PAV+ to select Spontaneous type.
Touch the desired trigger type (P
TRIG
or
V
TRIG
).
6.
Select tube type
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
C-4 Operator’s Manual
Figure C-1. Ventilator Setup Screen
PAV+
Note:
If the operator selects an internal diameter that does not correspond to the PBW/tube ID range pairs listed in the following table, touch C ontinue 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.
C.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.
Operator’s Manual C-5
PAV™+
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 the above PBW/tube ID range pairs, confirm or correct the settings. Confirming or correcting the actual ID size minimizes the likelihood that PAV+ will over-support or under-support.
To apply new settings for the artificial airway follow these steps
1.
Touch Vent Setup 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 t ube 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.
C.4.3
Apnea Parameters Adjustment
After accepting the PAV+ settings, touch the Apnea Setup screen. Adjust the Apnea parameters as required.
C.4.4
Alarm Settings Adjustment
PAV+ includes the high inspired tidal volume 2 V
TI
) and low exhaled spontaneous tidal volume alarm ( 4 V
TE SPONT
) alarm limit settings. Reference PAV+ Alarms , p. C-9.
C-6 Operator’s Manual
Note:
Because of the breathing variability that PAV+ allows, the
4
V
TE SPONT
alarm, by default, is turned OFF to minimize nuisance alarms. To monitor adequate ventilation, use the
3V
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.
C.4.5
PAV+ Ventilator Settings
•
•
•
•
•
Reference the table Ventilator Settings Range and Resolution , in
Chapter 11 of this manual for a
summary of PAV+ ventilator settings for the following parameters:
%
Supp
Expiratory sensitivity (E
SENS
)
Tube type
Tube ID
Trigger type
C.4.6
PAV+ Alarm Settings
•
•
Reference the table Alarm Settings Range and Resolution , in
Chapter 11 of this manual for a
summary of the following alarm settings available when PAV+ is active:
High inspired tidal volume limit (
2
V
TI
)
Low exhaled spontaneous tidal volume ( 4 V
TE SPONT
)
PAV+
Operator’s Manual C-7
PAV™+
C.4.7
Monitored Data
•
•
•
•
•
Reference
Patient Data Range and Resolution
in Chapter 11 of this manual for the following moni-
tored 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
TI
)
Reference the table below for monitored data absolute limits.
PBW (kg)
135
145
150
95
105
115
125
55
65
75
85
25
35
45
Table C-2. Absolute limits for PAV+ Monitored Data
R
PAV
(cmH
2
O/L/s)
0 to 50
0 to 44
0 to 31
0 to24
0 to 20
0 to 18
0 to 17
0 to 16
0 to 15
0 to 15
0 to 14
0 to 14
0 to 14
0 to 14
C
PAV
(mL/cmH
2
O)
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
E
PAV
(cmH
2
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
C-8 Operator’s Manual
Ventilator Settings/Guidance
C.4.8
PAV+ Alarms
•
•
•
•
•
Reference Non-technical Alarm Summary in
Chapter 6 of this manual for a summary of the follow-
ing alarms associated with PAV+:
High circuit pressure (
1
P
PEAK
)
High ventilator pressure(
1
P
VENT
)
PAV STARTUP TOO LONG
PAV R&C NOT ASSESSED
1
V
TI
C.5
Ventilator Settings/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 2 P
PEAK
to a safe circuit pressure, above which truncation and alarm annunciation are appropriate.
Note:
PAV+ has a built-in high pressure compensation (
1
P
COMP
) limit that is determined by the
2
P
PEAK
setting minus 5 cmH
2
O or 35 cmH
2
O, whichever is less. If the inspiratory pressure at the patient wye (P
Iwye
) reaches the
1
P
COMP
limit, the inspiration is truncated, and the ventilator transitions to exhalation. Reference for more details regarding
1
P
COMP
and
1
P
PEAK
.
Operator’s Manual C-9
PAV™+
C.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:
W = k ×
P i
V i
× d t
V i dt
---------------------------------i
W
P ith sample interval (5 ms )
Work [J/L]
Synchronous and combined pressures developed by the ventilator and by the patient (P
MUS
), [cmH
2
O]
V k
Flow [L/s] conversion constant (0.098) [J/cmH
2
O x L)
C.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 (Reference Graphics displays in PAV+ , p. C-12)
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
PT
) 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
), lung compliance (C
PAV
), and intrinsic PEEP (PEEP
I PAV
).
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.
C-10 Operator’s Manual
Ventilator Settings/Guidance
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.
C.5.3
WOB Terms and Definitions
The following table provides a definition and description of each of the Work of Breathing (WOB) terms.
Table C-3. PAV+ Work of Breathing terms
WOB term
WOB
TOT
Definition
Total Work of Inspiration
Description
With the PAV+ breath type active, the patient and the ventilator always share the in the work of breathing. The percent WOB
TOT
performed by the ventilator always equals the % Supp setting and the percent WOB
TOT
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.
WOB
PT
Patient Work of Breathing That part of WOB
TOT
performed by the patient.
WOB
PT ELASTIC
Inspiratory Elastic Work That part of WOB
PT elastic lung-thorax.
attributed to inflating the patient’s
WOB
PT RESIS-
TIVE
Inspiratory Resistive Work That part of the WOB
PT
attributed to moving breathing gas through resistive elements in the gas path.
Operator’s Manual C-11
PAV™+
Figure C-2. Graphics displays in PAV+
C-12
1
2
Total work of breathing (WOB
TOT
)
Patient’s work of breathing (WOB
PT
)
3 Shadow trace
C.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
).
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:
EQUATION 1
P
MUS
=
L
× R + V
L
× E
P
MUS
V
V
L
L
Pressure generating capability of patient’s inspiratory muscles
Flow through the resistance elements and into the lungs
Insufflation volume of the lung
R
E
LUNG-THORAX
Resistance elements (artificial plus patient airways)
Elastance of the lung and thorax (1/C
LUNG-THORAX
)
Operator’s Manual
Ventilator Settings/Guidance
Estimates of Patient Resistance and Elastance
If the PAV+ software estimates of patient resistance and elastance (R
PAV
and (E
PAV
) remain stable, this equation could be rewritten as:
EQUATION 2
P i
MUS
= V i
L
× R i airway
+ V i
L
× K
1
+ V i
L
× K
2 i Instantaneous value of pressure, flow, or airway resistance, R i airway
being a function of flow
E
PAV
K
1
R
PAV
K
2
P i
MUS
could then be estimated at every control period if V i
L
, R i airway
, and V i
L
were also known.
Valid Individual Pressure Measurements
Throughout any inspiration, the individual pressure elements that make up P
MUS
can be expressed as:
EQUATION 3 p
MUS
= P
FLOW
ARTIFICIAL AIRWAY
+ P
FLOW
PATIENT
+ P
VOLUME
PATIENT
P
MUS
P
FLOW
ARTIFICIAL
AIRWAY
Pressure generating capability of patient’s inspiratory muscles
Flow based pressure drop across the artificial airway
P
FLOW
PATIENT
P
VOLUME
PA-
TIENT
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
LUNG
, P wye
, and V
E
which yield an estimate for R
TOT
at the estimated flow.
Operator’s Manual C-13
PAV™+
All raw data are subjected to logic checks, and the estimates of R
PAV
and C
PAV
are further subjected to physiologic checks. The estimates of R
PAV
and C
PAV
are discarded if any of the logic or physiologic checks fail. If C
PAV
is rejected, R
PAV
is also rejected.
Valid estimates of 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. If new values for R
PAV
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 refresh.
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 i
L
, which is impeded by the resistances of the artificial airway and patient airways) and integrates this flow to yield an estimate of instantaneous lung volume, (V i
L),
which is impeded by the elastic recoil of the lung and thorax).
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 above information into consideration, EQUATION 2 can be rewritten to include the % Supp setting recognizing that V i
L
and V i
L
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
.)
C-14 Operator’s Manual
Ventilator Settings/Guidance
P i wye
=
EQUATION 4 i
L
× R i airway
) + ( i
L
× K
1
) + S V i
L
× K
2
)
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 pressure elements (in parentheses) in
Equation 4
S % Supp setting/100 (ranges from 0.05 to
0.95
Resulting Pressure Gradient
The pressure gradient driving breathing gas into the patient’s lungs is given by the sum of P i wye and the patient’s inspiratory effort, therefore:
EQUATION 5
Δ P i
GRADIENT
= P i wye
+ P i
MUS
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 capability of patient’s inspiratory muscles
C.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
and C
PAV
, PAV+ cannot start. If, after startup, the values of R
PAV
and C
PAV
cannot be updated with valid new values, the previous values become less reliable.
The stability of PAV+ is primarily determined by the relationship between the true lung elastance
[E
L
(true)] and the true lung volume [V
L
(true)]. Although P i
wye (resistive) also plays a part, the following discussion focuses on the elastic component.
At all lung volumes, the true state of the lung and thorax is expressed by:
Operator’s Manual C-15
PAV™+
P i
L recoil
= V i
L ( true )
× E
L ( true )
C-16
P i
L recoil
V i
L (true)
True lung recoil pressure
True instantaneous volume of the lung
E
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
L
(estimated) x K
2
] < V i
L
(true) x E
L
(true) where:
K
2
= E
PAV
1
1.
see equations 2 and 4
As long as E
PAV
(estimated) = E
PAV
(true) and V i
L
(estimated) = V i
L
(true) then P i recoil
> P i
wye even at high values of % Supp (i.e. between 85% and 95%).
This means that if the pressure applied to the lung-thorax is never greater than E
L
(true) x V
L
, lung volume will collapse if wye flow vanishes. As long as E
PAV
(estimated) ≤ E
L
(true), V i
L
(estimated) ≤
V i
L
(true), and R
PAV
(estimated) ≤ R
L
(true), P
MUS
is the modulator of P i
wye.
Hyperinflation could occur if the estimated E
PAV
were greater than the true value of E
L
. At a high
% Supp setting, P i
wye (elastic) could exceed P i
L recoil
, 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
L
at a high % Supp setting, P
Iwye
(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.
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 overinflation.
Operator’s Manual
Ventilator Settings/Guidance
3.
The high inspiratory tidal volume limit (
2
V
TI
) places an absolute limit on the integral of lung flow
(including leak flow), which equals lung volume. If the value of V
TI
reaches this limit, the ventilator truncates inspiration and immediately transitions to exhalation.
4.
The
2
V
TI setting places an upper limit on the value of the P
VOLUME
PATIENT
component of Piwye (see
Equations 3 and 4). At the beginning of each new inspiration, PAV+ software calculates a value for
P
VOLUME
PATIENT
as follows:
P*wye (elastic threshold limit) = 0.75 x (V
TI x E
PAV
)
5.
where P*wye is the unique value for the elastic threshold limit of Piwye that will cause the lung volume to expand to 75% of
2
V
TI
. When P i wye
(elastic) = P*wye (elastic threshold limit), the software stops increasing Piwye (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 reaching the 2 V
TI
limit.
The high inspiratory pressure limit (
2
P
PEAK
) applies to all breaths, and is used by PAV.+ software to detect the high compensation pressure condition (
1
P
COMP
):
1
P
COMP
=
2
P
PEAK
- 5 cmH
2
O or 35 cmH
2
O, whichever is less
If the user-adjustable
2
P
PEAK
limit is reached, the ventilator truncates inspiration and immediately transitions to exhalation. If P i wye
(the targeted wye pressure calculated in Equation 4) equals the
1
P
COMP for 500 ms , the inspiration is truncated and exhalation begins. Further, when P i wye
=
1
P
COMP
, P i wye
is limited to
1
P
COMP
. Although this freezes the value of P drive Piwye to
2
P
PEAK
, causing inspiration to end.
i wye
, patient activity such as coughing could
The rapid rise of P
R i wye to the
1
P
COMP
limit would likely occur in the first third of inspiration, and only if
PAV
were overestimated and % Supp were set above 85%. The
1
P
COMP
condition guards against overinflation due to overestimation of R
PAV
.
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
, which in turn could cause P i wye to reach
2
P
COMP
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.
Operator’s Manual C-17
PAV™+
7.
Spirometry remains active during PAV+ operation.
2
V
TI
can be set high enough to allow spontaneous sigh breaths, while
4V
E TOT
and
2V
E TOT
remain active to reveal changes in minute ventilation.
Because PAV+ cannot operate without valid estimates of R
PAV
and C
PAV
, and because those values are 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
PAV
, and both estimated values must be valid. If either value is invalid during any of the four startup breaths, the software schedules a substitute
maneuver breath at the next breath. Reference PAV+ , p. C-2.
A low-priority alarm becomes active if a 45-second interval elapses without valid estimates for R
PAV and C
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
1V
E TOT
and
1 f
TOT
alarms are also associated with this condition.
Similarly, if R
PAV
and C
PAV
cannot be updated with valid values after a successful PAV+ startup, a lowpriority 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. Reference the waveform and table below.
Figure C-3. Use of Default Lung Resistance
C-18
1
2
3
4
Flow (
V
)
Expiration
Inspiration
Exhalation with slow, restricted return to zero flow
5
6
7
High peak expiratory flow
Exhalation with normal return to zero flow
Normal peak expiratory flow
Operator’s Manual
Operator’s Manual
Ventilator Settings/Guidance
PBW
(kg)
37
38
39
40
33
34
35
36
41
42
29
30
31
32
25
26
27
28
15.2
14.9
14.7
14.5
16.2
15.9
15.7
15.4
Resistance
(cmH
2
O/L/s)
18.1
17.7
17.4
17.1
16.8
16.5
14.3
14.1
13.9
13.7
55
56
57
58
51
52
53
54
59
60
47
48
49
50
43
44
45
46
Table C-4. Default PBW-based Resistance Values
PBW
(kg)
PBW
(kg)
12.1
12.0
11.8
11.7
12.6
12.4
12.3
12.2
Resistance
(cmH
2
O/L/s)
13.5
13.3
13.2
13.0
12.9
12.7
11.6
11.5
11.4
11.3
10.5
10.5
10.4
10.4
10.8
10.7
10.7
10.6
Resistance
(cmH
2
O/L/s)
11.3
11.2
11.1
11.0
10.9
10.9
10.3
10.3
10.2
10.2
73
74
75
76
69
70
71
72
77
78
65
66
67
68
61
62
63
64
PBW (kg)
79
80
81 to 150
Resistance
(cmH
2
O/L/s)
10.1
10.1
10
C-19
PAV™+
Page Left Intentionally Blank
C-20 Operator’s Manual
D NeoMode 2.0
If NeoMode 2.0 is installed, see PT00047284.
D-1
NeoMode 2.0
Page Left Intentionally Blank
D-2 Operator’s Manual
E Proximal Flow
E.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, reference Chapter 4 in this
manual.
E.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.
E.3
Proximal Flow Option Description
The Proximal Flow Option measures pressure, flow, and volume at the patient wye. A 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 Card. 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. Reference Sensor Calibration and Sensor Line Purging , p. E-7 for more informa-
tion on the purge function.
E-1
Proximal Flow
E.3.1
Proximal Flow Option components
The Proximal Flow Option consists of the following components:
Proximal Flow Option PCBA — Installed on the Option Host Card 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.
Figure E-1. Proximal Flow Sensor
E-2
E.4
Safety Symbol Definitions
This section contains safety information for users who should always exercise appropriate caution while using the ventilator.
Operator’s Manual
Software/Hardware Requirements
Symbol
Table E-1. Safety Symbol Definitions
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.
E.5
Software/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
appendix.
E.6
Safety Information
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, in order to minimize risk of phthalate exposure in children and nursing or pregnant women, this product should only be used as directed.
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.
Operator’s Manual E-3
E-4
Proximal Flow
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 Option 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 Instructions for Use
(IFU) provided with the sensor.
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.
Operator’s Manual
On-screen symbols
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 buildup.
WARNING:
The Proximal Flow Sensor is intended for single use only. Do not re-use 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. Reference Attaching Proximal Flow Sensor , p. E-12.
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-branded Proximal Flow Sensors with the Proximal Flow Option.
E.7
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.
Operator’s Manual E-5
Proximal Flow
Figure E-2. Sample GUI screen Showing Proximal Flow Data
E-6
1 Data measured using Proximal Flow Sensor
P
Y
– Pressure throughout the breath cycle at patient circuit wye
V
Y
– 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 below, and correspond to their non-proximal flow equivalents. These values
appear in the patient data panel if so configured. Reference Vital Patient Data , p. 3-35 and the
figure above.
Data Symbol
V
TIY
V
TEY
V
TE SPONTY
V
TE MANDY
V
E TOTY
V
CIRC Y
V
TLY
Table E-2. Proximal Flow Option Data Symbols
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)
Operator’s Manual
Sensor Calibration and Sensor Line Purging
Note:
Note:
When the Proximal Flow and Leak Sync options are enabled, the following parameters are available for display:
V
TLY
and V
TL
•
• LEAK and LEAK
Y
When only the Proximal Flow option is enabled, V
TIY
and V
TI
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.
E.8
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.
Operator’s Manual E-7
Proximal Flow
Figure E-3. Message During Autozero and Purge Processes
E-8
E.9
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 in order 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. Reference
in Chapter 3 of this manual. There
is also a table listing the general SST test sequence located in that section. Reference the table below 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 Option. The ventilator will use its internal flow sensors for measurement instead of the Proximal Flow Option.
Operator’s Manual
SST Requirements
Test Step
SST Flow Sensor Cross Check
SST EV Performance
SST Circuit Pressure
SST Leak
SST Exhalation Filter
SST Circuit Resistance
SST Circuit Compliance
SST Prox
Table E-3. Proximal Flow Option SST test Sequence
Function
Tests O
2
and Air Flow Sensors
Calibrates the exhalation valve and creates a table for use during calculations.
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 occlusion and exhalation compartment occlusion.
N/A
N/A
N/A
N/A
Comments
Ventilator prompts the user to block the proximal flow sensor outlet during Leak test. When prompted to reconnect the patient to the exhalation filter during the Exhalation Filter test, resume blocking the proximal flow sensor outlet.
N/A 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 Proximal
Flow System.
N/A
Includes tests of barometric pressure, autozero, purge, and pressure cross check functions.
E.9.1
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.
Operator’s Manual E-9
Proximal Flow
Figure E-4. Attaching Proximal Flow Sensor to Ventilator
E-10
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. Reference the
Puritan Bennett™ 980 Series Ventilator Hardware Options Installation Instructions , p/n 10084704 for instructions on replacing the Proximal Flow Option hardware.
E.10
Disabling/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 vent 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.
Operator’s Manual
Using the Proximal Flow Sensor
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.
Figure E-5. Enabling/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.
E.11
Using the Proximal Flow Sensor
To connect the Proximal Flow Sensor to the ventilator:
1.
Verify the Proximal Flow Sensor, 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
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. Reference the figure below. Do not force the connection; when the sensor is oriented correctly, insertion requires little effort.
Operator’s Manual E-11
Proximal Flow
Note:
If using a Heat-Moisture Exchanger (HME) on the endotracheal tube, place the Proximal Flow Sensor between the HME and the breathing circuit wye.
Figure E-6. Attaching Proximal Flow Sensor
E-12
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:
4.
a.
b.
Grasp the sensor’s plastic body with one hand and the breathing circuit wye with the other hand.
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.
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.
Operator’s Manual
Alarms
E.11.1
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.
Reference Message During Autozero and Purge Processes , p. E-8.
Figure E-7. Manual Purge
E.12
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 Sensor is not detected
Pressure and flow readings are out of range
Hardware problems are reported by the Proximal Flow Option PCBA
Operator’s Manual E-13
Proximal Flow
• 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 below.
Follow the information contained in the remedy message to troubleshoot the alarm.
Figure E-8. Alarm Message — Prox Inoperative
E-14
E.13
Ranges, Resolutions, and Accuracies
Reference Patient Data Range and Resolution in
Chapter 11 of this manual for Proximal exhaled tidal
volume, Proximal inspired tidal volume, Proximal exhaled minute volume, and Proximal flow patient data parameters.
Operator’s Manual
Part Numbers
E.13.1
Proximal Flow Sensor Specifications
Table E-4. Proximal Flow Sensor Volume Accuracy
Measurement
Accuracy
1
± (1.0 mL + 10% of reading) Exhaled tidal volume
Inspired tidal volume ± (1.0 mL + 10% of reading)
1.
The conditions under which the accuracy values apply are as follows:
Sensor is used as described in this appendix and/or the Instructions for Use provided with the sensor
Table E-5. Proximal Flow Sensor Specifications
Parameter
Weight
Dead space
Pressure drop
Specification
6.6 g
< 1 mL
1.5 cmH
2
O at 10 L/min
E.14
Part Numbers
The following table lists the part numbers for the Proximal Flow Option Kit and individual components.
Table E-6. Proximal Flow Option and Component Part Numbers
Item
Proximal Flow Option Kit
Part Number
10084331
Includes:
Installation hardware and accessories
Proximal Flow Sensor, Neonatal (package of 10)
NOTE : Includes 3 cable management clips
Proximal Flow Sensor module
Interconnect PCBA
Purge Control Cable
Purge Supply Line
PCBA Mounting Screws
Proximal Flow Option Label
10047078
10087622
10083941
10083940
10083966
10083963
10005748
Operator’s Manual E-15
Proximal Flow
Page Left Intentionally Blank
E-16 Operator’s Manual
Glossary
Table Glossary-1. Glossary of Ventilation Terms analysis message assist breath assist-control A/C mode audio paused (alarm silence) augmented alarm autotriggering background checks
A message displayed on the GUI screen during an alarm condition, identifying the root cause of the alarm.
A mandatory breath triggered by patient inspiratory effort in A/C and SIMV modes.
A ventilation mode where only mandatory VC, PC, or VC+breaths are delivered to the patient.
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.
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.
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.
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
TRIG
). The value of this base flow is 1.5 L/ min greater than the operator selected value for flow sensitivity.
base message batch changes
A message given by the ventilator during an alarm condition, identifying the alarm.
Changes to multiple settings that go into effect at the same time.
battery back-up system
BD, BDU
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.
Breath delivery or breath delivery unit. The ventilator component that includes inspiratory and expiratory pneumatics and electronics.
Glossary-1
Glossary-2
BiLevel mode
BOC breath stacking
BTPS cmH
D
EST
2
SENS
O compliance volume compressor constant during rate change control breath
CPU dependent alarm
DISS
E
SENS
EVQ expiratory pause exhalation valve (EV)
Table Glossary-1. Glossary of Ventilation Terms (Continued)
A mixed ventilation mode combining mandatory and spontaneous breaths, where two levels of pressure are delivered (P
L
and P
H
) corresponding to expiratory and inspiratory times T
L and T
H
.
British Oxygen Company. A standard for high pressure gas inlet fittings.
The delivery of a second inspiration before the first exhalation is complete.
Body temperature and pressure, saturated, 37°C, at ambient barometric pressure, at 100% relative humidity.
Centimeters of water. A unit of pressure approximately equal to 1 hPa.
The volume of gas that remains in the patient circuit and does not enter the patient's respiratory system.
The compressor provides compressed air, which can be used in place of wall or bottled air.
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).
A ventilator-initiated mandatory breath delivered in A/C mode
Central processing unit. The electronic components of the ventilator (BD and
GUI) responsible for interpreting and executing instructions entered by the operator.
An alarm that arises as a result of another primary alarm (also referred to as an augmentation).
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 is the maximum allowable leak rate and is expressed in terms of
L/min.
Diameter index safety standard. A standard for high pressure gas inlet fittings.
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.
Extended self test. A comprehensive test of ventilator function, intended to be run by qualified service personnel.
The exhalation flow sensor assembly.
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
I
).
The valve in the expiratory limb of the ventilator breathing system that controls PEEP.
Operator’s Manual
Operator’s Manual
Table Glossary-1. Glossary of Ventilation Terms (Continued) f , f
TOT
FAILURE
Respiratory rate, as a setting ( f ) in A/C, SIMV, and BiLevel the minimum number of mandatory breaths the patient receives per minute. As a monitored value
(f
TOT
), the average total number of breaths delivered to the patient.
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.
flow pattern A setting that determines the gas flow pattern of mandatory volume-controlled breaths.
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 high-priority alarm
HME hPa humidification type
I:E ratio inspiratory pause invasive ventilation kPa latched alarm
L/min low-priority alarm lockable alarm
A ventilator setting that has reached its minimum or maximum limit.
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.
Heat-moisture exchanger. A humidification device, also called an artificial nose.
Hectopascal. A unit of pressure, approximately equal to 1 cmH
2
O
A setting for the type of humidification system (HME, non-heated expiratory tube, or heated expiratory tubing) in use on the ventilator.
The ratio of inspiratory time to expiratory time. Also, the operator- set timing variable that applies to PC and VC+ mandatory breaths.
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
).
Patient ventilation while intubated with an endotracheal (or tracheostomy) tube.
Kilopascal. A unit of pressure approximately equal to 10 cmH
2
O.
An alarm whose visual alarm indicator remains illuminated after the alarm has autoreset.
Liters per minute. A unit of flow.
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.
An alarm that does not terminate an active alarm silence function.
Glossary-3
Glossary-4 maintenance mandatory breath mandatory type manual inspiration medium-priority alarm mode
NIST non-invasive ventilation
(NIV) non-technical alarm normal ventilation
O
2
%
OIM ongoing background checks
OSC
OVERRIDDEN patient circuit patient data alarm
Table Glossary-1. Glossary of Ventilation Terms (Continued)
All actions necessary to keep equipment in, or restore it to, serviceable condition. Includes cleaning, servicing, repair, modification, overhaul, inspection, and performance verification.
A breath whose settings and timing are preset; can be triggered by the ventilator, patient, or operator.
The type of mandatory breath: volume control (VC), VC+ or pressure control
(PC).
An operator-initiated mandatory (OIM) breath.
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.
Ventilatory mode. The algorithm that determines type and sequence of breath delivery.
Non-interchangeable screw thread. A standard for high pressure gas inlet fittings.
Patient ventilation without the use of an endotracheal tube; instead using interfaces such as masks, nasal prongs, or uncuffed endotracheal tubes.
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.
The state of the ventilator when breathing is in progress and no alarms are active.
Both a ventilator setting and a monitored variable. The O
2
% setting determines the percentage of oxygen in the delivered gas. The O
2
% monitored data is the percentage of oxygen in the gas delivered to the patient, measured at the ventilator outlet upstream of the inspiratory filter.
Operator-initiated mandatory breath. A breath delivered when the operator presses the MANUAL INSP key.
Continuously running tests during ventilation that assess the ventilator's electronics and pneumatics hardware.
Occlusion status cycling. A ventilation mode in effect during a severe occlusion. In this mode, the ventilator periodically attempts to deliver a pressurebased breath while monitoring the inspiration and expiration phases for the continuing existence of the occlusion.
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.)
The entire inspiratory-expiratory conduit, including tubing, humidifier, and water traps.
An alarm condition associated with an abnormal condition of the patient's respiratory status.
Operator’s Manual
Operator’s Manual patient problems
PBW
PC
PE
PEEP
PEEPI
P
PI
P
P
P
P
I
I END
PIM
MEAN
PEAK primary alarm
PS
SENS
PSOL
P
SUPP
Table Glossary-1. Glossary of Ventilation Terms (Continued)
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.
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.
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.
Expiratory pressure transducer.
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.
Intrinsic PEEP. Indicates a calculated estimate of the pressure above the PEEP level at the end of exhalation. Determined during an expiratory pause maneuver.
Inspiratory pressure. The operator-set inspiratory pressure at the patient wye
(above PEEP) during a pressure control (PC) mandatory breath.
Inspiratory pressure transducer.
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.
Patient-initiated mandatory breath. A mandatory breath triggered by patient inspiratory effort.
Mean circuit pressure, a calculation of the measured average patient circuit pressure over an entire respiratory cycle.
Maximum circuit pressure, the maximum pressure during the inspiratory and expiratory phases of a breath.
An initial alarm.
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.
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.
Proportional solenoid valve.
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).
Glossary-5
Glossary-6
P
TRIG remedy message resistance restricted phase of exhalation rise time % safety net safety valve (SV) safety ventilation service mode
SIMV
SIS soft bound
SPONT spontaneous type
Table Glossary-1. Glossary of Ventilation Terms (Continued)
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
).
A message displayed on the GUI during an alarm condition suggesting ways to resolve the alarm.
The flow-dependent pressure drop across a conduit. Measured in cmH
2
O/L/s or hPa/L/s.
The time period during the exhalation phase where an inspiration trigger is not allowed. The restricted phase of exhalation is defined as the first 200 ms 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
O
2
% (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.
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.
The ventilator's strategy for responding to patient problems and system faults.
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.
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.
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.
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.
Sleeved index system. A standard for high pressure gas inlet fittings.
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.
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.
A setting that determines whether spontaneous breaths are pressure-supported (PS), tube-compensated (TC), volume-supported (VS), or proportionally assisted (PAV).
Operator’s Manual
Operator’s Manual
SST
STPD
SVO system fault
T
Tb
T
T
A
E technical alarm
T
I
Tm
PL
Ts
V
E TOT
VBS
VC
Table Glossary-1. Glossary of Ventilation Terms (Continued)
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.
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.
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.
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.
Breath time cycle during mechanical 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.
An alarm occurring due to a violation of any of the ventilator's self monitoring conditions, or detected by background checks.
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.
Mandatory interval portion of SIMV breath cycle; it is reserved for a PIM.
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.
Spontaneous interval portion of SIMV breath cycle; it is reserved for spontaneous breathing throughout the remainder of the breath cycle.
Minute volume, the expiratory tidal volume normalized to unit time
(L/min). The displayed value is compliance- and BTPS-compensated.
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.
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.
Glossary-7
Glossary-8
L lb m mL cm ft
Hz kg ms s
V
Ventilation Assurance
Table Glossary-1. Glossary of Ventilation Terms (Continued)
Ventilator Inoperative
(vent inop)
VIM
V
V
V
T
V
MAX
SENS
TRIG
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.
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.
Ventilator-initiated mandatory breath. A breath that is delivered at a time determined by the ventilator
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.
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).
Tidal volume. A setting that determines the volume inspired and expired with each breath. The V
T
delivered by some Puritan Bennett ventilators is an operator-set variable that determines the volume delivered to the patient during a mandatory, volume-based breath. V
T
is compliance-compensated and corrected to body temperature and pressure, saturated (BTPS).
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
).
Table Glossary-2. Units of Measure
Centimeter. A unit of length.
Feet. A unit of length.
Hertz. A unit of frequency, indicating cycles per second.
Kilogram. A unit of weight
Liter. A unit of volume
Pound. A unit of weight.
Meter. A unit of length.
Milliliter. A unit of volume.
Millisecond. A unit of time.
Second. A unit of time
Volts. A unit of voltage
Operator’s Manual
Operator’s Manual
VA
Table Glossary-2. Units of Measure (Continued)
Volt-amperes. A unit of power.
AC, also ac
ASCII
CE
CSA
CRC
DC, also dc
EMC
EN
ETO
IEC
ISO
LCD
LED
MRI
NVRAM, also NovRam
POST
RAM
Table Glossary-3. Technical Abbreviations
Alternating current. The movement of electrical charge that periodically reverses direction.
American Standard Code for Information Interchange. A standard character encoding scheme.
A certification mark issued under the authority of the European Common
Market that indicates compliance with the Medical Device Directive, 93/42/
EEC.
Canadian Standards Association.
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.
Direct current. The movement of electrical charge flowing in a single direction.
Electromagnetic compatibility.
European norm (referring to the European Common Market).
Ethylene oxide.
International Electrotechnical Commission. A standards organization.
International Standards Organization. A standards organization.
Liquid crystal display. A type of visual equipment-operator Interface.
Light-emitting diode. A means of providing visual indications.
Magnetic resonance imaging.
Non-volatile random access memory. Memory that is kept active across resets and power cycles and is not normally initialized at startup.
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.
Random access memory.
Glossary-9
Page Left Intentionally Blank
Glossary-10 Operator’s Manual
Index
A
A/C mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25–10-27
AC power operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
accessory
compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
adjusting waveform layout . . . . . . . . . . . . . . . . . . . . .3-37
alarm
AC POWER LOSS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-29
Apnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-30
audio paused key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
CIRCUIT DISCONNECT . . . . . . . . . . . . . . . . . . . . . . . .6-30
dependent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
DEVICE ALERT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-31
High circuit pressure . . . . . . . . . . . . . . . . . . . . . . . . .6-31
High delivered O
2
% . . . . . . . . . . . . . . . . . . . . . . . . . .6-31
High exhaled minute volume . . . . . . . . . . . . . . . .6-32
High exhaled tidal volume . . . . . . . . . . . . . . . . . . .6-32
High inspired tidal volume . . . . . . . . . . . . . . . . . . .6-32
High respiratory rate . . . . . . . . . . . . . . . . . . . . . . . . .6-33
how to test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
INSPIRATION TOO LONG . . . . . . . . . . . . . . . . . . . . .6-33
Loss of power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-30
Low circuit pressure . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Low delivered O
% . . . . . . . . . . . . . . . . . . . . . . . . . .6-34
Low exhaled mandatory tidal volume . . . . . . . .6-34
Low exhaled spontaneous tidal volume . . . . . .6-35
Low exhaled total minute volume . . . . . . . . . . . .6-35
non-technical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
primary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
prioritization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
PROCEDURE ERROR . . . . . . . . . . . . . . . . . . . . . . . . . .6-35
reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
technical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Alarm Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
alarm settings range and resolution . . . . . . . . . . . 11-18
alarm settings range and resolution . . . . . . . . . . . 11-16
Apnea Ventilation . . . . . . . . . . . . . . .10-33–10-37, 10-46
Apnea Ventilation in SIMV . . . . . . . . . . . . . . . . . . . . 10-36
Authorized Representative . . . . . . . . . . . . . . . . . . . . . .1-16
B
Background Diagnostic System . . . . . . . . . . . . . . . 10-61
battery
life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20
battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
BDU indicators
audible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-33
visual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25
Breath Delivery Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23
Breath triggers
flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
operator-initiated . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
time-cycled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
BUV settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
C
Circuit Type and PBW . . . . . . . . . . . . . . . . . . . . . . . . . 10-47
compliance compensation . . . . . . . . . . . . . 10-10–10-13
Volume-based Breaths . . . . . . . . . . . . . . . . . . . . . 10-10
compliant cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36
Component Cleaning and Disinfection . . . . . . . . . . .7-5
Component Sterilization . . . . . . . . . . . . . . . . . . . . . . . 7-17
Computed value accuracy . . . . . . . . . . . . . . . . . . . . 11-27
configurable features
alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
large font patient data . . . . . . . . . . . . . . . . . . . . . . . 3-36
patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37
Connectivity to External Patient
Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Constant Timing Variable for Rate Changes . . . . . 4-17
Covidien Technical Services
Solv-IT Center Knowledge Base . . . . . . . . . . . . . . 1-15
D
Delivery accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25
Detecting Occlusion and Disconnect . . . 10-37–10-40
Disconnect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
Disconnect Sensitivity (D
) . . . . . . . . . . . . . . . . . 10-57
Display
E
EMC
compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-30
recommended separation distances . . . . . . . . 11-34
exhalation
airway pressure method . . . . . . . . . . . . . . . . . . . . . 10-7
high circuit pressure limit (backup method) . . 10-9
high inspired tidal volume limit
(backup method) . . . . . . . . . . . . . . . . . . . . . . . . 10-10 high ventilator pressure limit
(backup method) . . . . . . . . . . . . . . . . . . . . . . . . 10-10
percent peak flow method . . . . . . . . . . . . . . . . . . 10-8
Exhalation — Detection and Initiation . . . 10-7–10-10
Index-1
Index-2 expiratory module
Expiratory Pause . . . . . . . . . . . . . . . . . . . . . . . 10-43–10-44
Expiratory Pause Maneuvers . . . . . . . . . . . . . . . . . . . .4-27
Expiratory Sensitivity (E
) . . . . . . . . . . . . . . . . . . 10-57
Expiratory Time (T
) . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
extended battery installation . . . . . . . . . . . . . . . . . . .3-19
Extended Self Test (EST) . . . . . . . . . . . . . . . . . . . . . . 10-64
F
Filter Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Flow Pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Flow Sensitivity (
V
SENS
) . . . . . . . . . . . . . . . . . . . . . . . 10-52
G
gas failure cross flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Gestures
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5–4-7
double-tap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
drag and drop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
touch and hold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
gestures
Graphical User Interface (GUI) . . . . . . . . . . . . . . . . . . .2-13
GUI Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
GUI control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
GUI indicators
audible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23
visual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16–2-18
GUI screen capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
H
hard bound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
High Pressure (P
H
) in BiLevel . . . . . . . . . . . . . . . . . . 10-54
High Spontaneous Inspiratory Time Limit (
2
T
I SPONT
High Time (T
H
) in BiLevel . . . . . . . . . . . . . . . . . . . . . 10-54
How to Connect the Gas Supplies . . . . . . . . . . . . . . . . 3-6
How to Connect the Patient Circuit . . . . . . . . . . . . .3-12
How to connect the Ventilator to AC Power . . . . . . 3-4
how to enter Service mode . . . . . . . . . . . . . . . . . . . . .3-28
How to Install Accessories . . . . . . . . . . . . . . . . 3-16–3-24
How to Store the Ventilator for an Extended Time
Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
how to use the ventilator system . . . . . . . . . . . 4-7–4-18
how to use the ventilator’s user interface . . . . 4-2–4-7
how to view ventilator logs . . . . . . . . . . . . . . . . . . . . . . 8-3
Humidification Type . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58
humidifier installation . . . . . . . . . . . . . . . . . . . . . . . . . .3-22
Humidifier Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
I
I:E ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
icons
configure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
elevate O
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
screen capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
unread items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
ventilator setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
waveform layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
IEC classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Inspiration — Detection and Initiation . . . . .10-4–10-7
Inspiratory Pause . . . . . . . . . . . . . . . . . . . . . . 10-41–10-43
Inspiratory pause maneuvers . . . . . . . . . . . . .4-26, 10-41
Inspiratory Pressure (P
) . . . . . . . . . . . . . . . . . . . . . . . 10-53
Inspiratory Time (T
) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53
L
Low Pressure (P
) in BiLevel . . . . . . . . . . . . . . . . . . . 10-54
Low Time (T
) in BiLevel . . . . . . . . . . . . . . . . . . . . . . . 10-55
M
Mandatory Breath Delivery . . . . . . . . . . . . . . . . . . . . 10-13
Manual Inspiration . . . . . . . . . . . . . . . . . . . . . . .4-24, 10-18
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . 11-29
Measurement Uncertainty . . . . . . . . . . . . . . . . . . . . . 11-1
MISCA response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
MISCF response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Mode and Breath Type . . . . . . . . . . . . . . . . . . . . . . . . 10-49
Monitored Patient Data . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Monitoring accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25
N
NIV
alarm settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
apnea settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
high spontaneous inspiratory time limit setting . 4-
setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
Non-invasive ventilation (NIV) . . . . . . . . . . . . .4-19–4-24
O
Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-37
Omni-directional LED . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
On-screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
On-screen Symbols and Abbreviations . . . .2-19–2-22
Operation Verification . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50
oxygen sensor
Index
function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28
P
P
0.1
maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
Patient Data Parameters . . . . . . . . . . . . . . . . . . 6-36–6-42
patient data range and resolution . . . . . . 11-18–11-24
Patient Related Problems . . . . . . . . . . . . . . . . . . . . . 10-61
Peak Inspiratory Flow (
V
) . . . . . . . . . . . . . . . . . 10-51
PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Percent Support in PAV+ . . . . . . . . . . . . . . . . . . . . . . 10-56
Percent Support in TC . . . . . . . . . . . . . . . . . . . . . . . . 10-56
physical characteristics . . . . . . . . . . . . . . . . . . . . . . . . .11-3
Plateau Pressure (P
) . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39
Plateau Time (T
PL)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51
Pneumatic Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-35
Power On Self Test (POST) . . . . . . . . . . . . . . . . . . . . 10-63
Preparing the Ventilator for Use . . . . . . . . . . . . . . . . .3-31
Pressure Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Pressure Support (P
) . . . . . . . . . . . . . . . . . . . . . . 10-55
primary battery installation . . . . . . . . . . . . . . . . . . . . .3-17
Primary display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Printing data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
Product Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
pushpin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Q
quick start use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
R respiratory maneuvers
expiratory pause maneuver . . . . . . . . . . . . . . . . 10-43
inspiratory pause maneuver . . . . . . . . . . . . . . . . 10-41
NIF maneuver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-44
respiratory mechanics maneuvers
Negative Inspiratory Force maneuver (NIF) . . 10-44
P
Respiratory Rate (f ) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-50
Rise Time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56
RS-232 commands
RSET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
SNDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
SNDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
S
Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-36
screen captures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Serial commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
serial number interpretation . . . . . . . . . . . . . . . . . . . .1-16
settings
alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14
apnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
return to previous . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17
ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
Short Self Test (SST) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-63
SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
SIMV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-32
soft bound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
specifications
electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
physical characteristics . . . . . . . . . . . . . . . . . . . . . . 11-3
Spontaneous (SPONT) Mode . . . . . . . . . . . 10-32–10-33
Spontaneous Breath Delivery . . . . . . . . . . . . . . . . . . 10-18
SST
how to run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40
outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43
results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42
test sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40
Status Display . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-25–2-33
Surface Cleaning of Exterior Surfaces . . . . . . . . . . . . .7-4
symbols
BDU rear panel label symbols and descriptions .2-9
safety symbol definitions . . . . . . . . . . . . . . . . . . . . . .1-3
shipping label symbols and descriptions . . . . . . .1-2
System Related Problems . . . . . . . . . . . . . . . . . . . . . 10-61
T
TC
PBW and tube ID . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
technical description . . . . . . . . . . . . . . . . . . . . . . . 10-22
tube type, tube ID, humidification . . . . . . . . . . . 4-12
technical assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Tidal Volume (V
T
) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51
U
Used Part Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Using Battery Power . . . . . . . . . . . . . . . . . . . . . . . . 3-2–3-3
V
VC+
maximum pressure adjustments . . . . . . . . . . . . 10-17
startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Vent Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-48
ventilator
alarm log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
available languages . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
BDU controls and indicators . . . . . . . . . . . . . . . . . 2-24
BDU front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
BDU rear label symbols and descriptions . 2-9–2-11
BDU rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
BDU right side view . . . . . . . . . . . . . . . . . . . . 2-12, 2-13
Index-3
Index-4
Components List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-33
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
EST/SST status log . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
gas flow overview . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2
general event log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
GUI front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
GUI rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7–4-19
patient data log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
service log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Ventilator Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Ventilator Operating Modes . . . . . . . . . . . . . . 3-25–3-29
ventilator operating modes
Normal mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Quick Start mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Service mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
Stand-By state . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Ventilator Protection Strategies . . . . . . . . . . . 4-30–4-32
ventilator settings
2
T
I SPONT
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58
apnea ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46
circuit type and PBW . . . . . . . . . . . . . . . . . . . . . . . 10-47
configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32–3-38
disconnect sensitivity (D
) . . . . . . . . . . . . . . . 10-57
expiratory sensitivity (E
SENS
) . . . . . . . . . . . . . . . . 10-57
expiratory time (T
E
) . . . . . . . . . . . . . . . . . . . . . . . . 10-54
flow pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
flow sensitivity (
V
) . . . . . . . . . . . . . . . . . . . . . 10-52
high pressure (P
) . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
high time (T
) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
humidification type . . . . . . . . . . . . . . . . . . . . . . . . 10-58
humidifier volume . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
I:E ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
inspiratory pressure (P
) . . . . . . . . . . . . . . . . . . . . . 10-53
inspiratory time (T
) . . . . . . . . . . . . . . . . . . . . . . . . 10-53
low pressure (P
L
) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
low time (T
L
) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
mode and breath type . . . . . . . . . . . . . . . . . . . . . 10-49
peak inspiratory flow (
V
) . . . . . . . . . . . . . . . . 10-51
PEEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
percent support in TC . . . . . . . . . . . . . . . . . . . . . . 10-56
plateau time (T
PL
) . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51
pressure sensitivity (P
) . . . . . . . . . . . . . . . . . . 10-52
pressure support (P
) . . . . . . . . . . . . . . . . . . . . 10-55
range and resolution . . . . . . . . . . . . . . . . . 11-9–11-16
respiratory rate (f ) . . . . . . . . . . . . . . . . . . . . . . . . . . 10-50
rise time % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56
tidal volume (V
T
) . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51
vent type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-48
volume support (V
) . . . . . . . . . . . . . . . . . . . 10-56
Ventilator Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
Volume Support (V
) . . . . . . . . . . . . . . . . . . . . . 10-56
VS
W
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
waveform axis scaling . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37
Part No. PT00100763 A 2019-0
4
© 2013 Covidien. All rights reserved.
Covidien llc
15 Hampshire Street, Mansfield, MA 02048
Covidien Ireland Limited, IDA Business and Technology Park, Tullamore
Ireland.
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