T1 Patient Monitor Operator`s Manual

T1 Patient Monitor

Operator’s Manual

Copyright 2014 - 2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

Release time: October 2016

Revision: 4.0

WARNING



Federal Law (USA) restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or order the use of this device.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Please refer to www.mindrayna.com/patents/ for a complete list of applicable patents and trademarks.

T1 Patient Monitor Operator’s Manual I

II

Manufacturer’s Responsibility

Contents of this manual are subject to changes without prior notice.

All information contained in this manual is believed to be correct. Mindray is not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

 all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

 the electrical installation of the relevant room complies with the applicable national and local requirements;

 the product is used in accordance with the instructions for use.

WARNING





Only skilled/trained clinical professionals should operate this equipment.

It is important for the hospital or organization that uses this equipment to perfrom a recommended service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.



If there is any inconstancy or ambiguity between the latest English version and this manual, the English version shall prevail.

Warranty

Mindray warrants that components within its products will be free from defects in workmanship and materials for a period of one year from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner.

This warranty does not cover consumable items such as, but not limited to, batteries, external cables, and sensors.

Mindray shall not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing the affected products, at Mindray option, at the factory or at an authorized distributor, for any product which shall under normal use and service appear to Mindray to have been defective in material or workmanship. Recommended preventative maintenance, as prescribed in the service manual, is the responsibility of the user and is not covered by this warranty.

No agent, employee, or representative of Mindray has any authority to bind Mindray to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer or user.

T1 Patient Monitor Operator’s Manual

THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED

WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A

PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF MINDRAY.

Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory attachments, or by any customer modification voids this warranty. Mindray makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of their respective manufacturers.

A condition of this warranty is that the equipment or accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mahwah, New Jersey 07430 or its authorized representative.

Mindray shall not have any responsibility in the event of loss or damage in transit

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.

This warranty does not extend to:

 Malfunction or damage caused by improper use or man-made failure.

 Malfunction or damage caused by unstable or out-of-range power input.

 Malfunction or damage caused by force majeure events, such as (i) flood, fire and earthquake or other similar elements of nature or acts of God; (ii) riots, war, civil disorders, rebellions, or revolutions in any country; or (iii) any other cause beyond the reasonable control of Mindray.

 Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

 Malfunction of the instrument or part whose serial number is not legible.

 Others not caused by instrument or part itself.

T1 Patient Monitor Operator’s Manual III

Service

Mindray maintains a network of service representatives and factory-trained distributors. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist,

In North America contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201) 995-8000 for assistance in determining the nearest field service location.

Please include the instrument model number, the serial number, and a description of the problem with all requests for service.

Any questions regarding the warranty should be directed to your local sales or service representative.

NOTE



Upon request, Mindray provides circuit diagrams, component part lists, descriptions, calibration instructions, or other information which assist the user’s appropriately qualified technical personnel to repair those parts of the equipment which are designated by Mindray DS USA, Inc. as repairable.

IV T1 Patient Monitor Operator’s Manual

Company Contact

Manufacturer:

Address:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Mindray Building, Keji 12th Road South,Hi-tech industrial park, Nanshan,

Shenzhen 518057,P.R.China

Website: www.mindray.com

E-mail Address:

Tel:

Fax: [email protected]

+86 755 81888998

+86 755 26582680

Distributor:

Address:

Mindray DS USA, Inc.

800 MacArthur Boulevard, Mahwah, New Jersey, 07430 USA

Website: www.mindray.com

T1 Patient Monitor Operator’s Manual V

Preface

Manual Purpose

This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any questions, please contact Mindray.

This manual is an integral part of the product. It should always be kept close to the equipment so that it can be conveniently referenced when needed.

NOTE



If your equipment has any function that is not included in this manual, refer to the latest English version.

Intended Audience

This manual is intended for clinical professionals who are expected to have a corresponding working knowledge of medical procedures, practices and terminology as required for monitoring of patients.

Illustrations

All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your monitor.

Conventions

 Italic text is used to quote the referenced chapters or sections.

 [ ] is used to enclose screen text.

 → is used to indicate operational procedures.

VI T1 Patient Monitor Operator’s Manual

Contents

1 Safety ................................................................................................................................................................................. 1-1

1.1 Safety Information .......................................................................................................................................................................................... 1-1

1.1.1 Warnings .............................................................................................................................................................................................. 1-2

1.1.2 Cautions ............................................................................................................................................................................................... 1-3

1.1.3 Notes ..................................................................................................................................................................................................... 1-3

1.2 Equipment Symbols ....................................................................................................................................................................................... 1-4

2 The Basics ........................................................................................................................................................................... 2-1

2.1 Monitor Description ....................................................................................................................................................................................... 2-1

2.1.1 Intended Use ...................................................................................................................................................................................... 2-1

2.1.2 Equipment Features ......................................................................................................................................................................... 2-2

2.1.3 Applied Parts ...................................................................................................................................................................................... 2-2

2.2 Equipment Description ................................................................................................................................................................................ 2-3

2.2.1 Main Unit ............................................................................................................................................................................................. 2-3

2.2.2 T1 handle ............................................................................................................................................................................................. 2-6

2.2.3 T1 Docking Station ........................................................................................................................................................................... 2-7

2.2.4 External Parameter Modules......................................................................................................................................................... 2-8

2.3 Installation ......................................................................................................................................................................................................... 2-9

2.3.1 T1 in Use with the T1 Handle ........................................................................................................................................................ 2-9

2.3.2 T1 Handle in Use with the T1 Docking Station .....................................................................................................................2-10

2.3.3 T1 in Use with the T1 Docking Station ....................................................................................................................................2-11

2.4 Display Screen ................................................................................................................................................................................................2-12

3 Basic Operations ................................................................................................................................................................ 3-1

3.1 Installation ......................................................................................................................................................................................................... 3-1

3.1.1 Unpacking and Checking .............................................................................................................................................................. 3-2

3.1.2 Environmental Requirements ...................................................................................................................................................... 3-2

3.2 Getting Started ................................................................................................................................................................................................ 3-3

3.2.1 Connecting to Power Source ........................................................................................................................................................ 3-3

3.2.2 Turning Power On ............................................................................................................................................................................. 3-4

3.2.3 Starting Monitoring ......................................................................................................................................................................... 3-4

3.3 Turning Off the Monitor ............................................................................................................................................................................... 3-5

3.4 Using the Touchscreen .................................................................................................................................................................................. 3-5

3.5 Using the On-Screen Keyboard ................................................................................................................................................................. 3-6

3.6 Using the External Display ........................................................................................................................................................................... 3-6

3.7 Using the Mouse and Keyboard ................................................................................................................................................................ 3-7

3.8 Using the Main Menu .................................................................................................................................................................................... 3-7

3.9 Changing General Settings ......................................................................................................................................................................... 3-8

3.9.1 Setting Up a Monitor ....................................................................................................................................................................... 3-8

3.9.2 Changing Language ........................................................................................................................................................................ 3-8

3.9.3 Setting the Date and Time ............................................................................................................................................................. 3-8

3.9.4 Setting the Docking Station ......................................................................................................................................................... 3-9

3.10 Setting Parameters ....................................................................................................................................................................................3-10

T1 Patient Monitor Operator’s Manual 1

3.10.1 Switching the Parameters On/Off ..........................................................................................................................................3-10

3.10.2 Accessing the Parameters Menu .............................................................................................................................................3-10

3.11 Operating Modes .......................................................................................................................................................................................3-10

3.11.1 Monitoring Mode .........................................................................................................................................................................3-10

3.11.2 Night Mode .....................................................................................................................................................................................3-11

3.11.3 Privacy Mode..................................................................................................................................................................................3-11

3.11.4 Outdoor Mode ...............................................................................................................................................................................3-12

3.11.5 Module Mode ................................................................................................................................................................................3-12

3.11.6 Standby Mode ...............................................................................................................................................................................3-14

4 Managing Patients ............................................................................................................................................................ 4-1

4.1 Admitting a Patient ........................................................................................................................................................................................ 4-1

4.2 Quick Admitting a Patient ........................................................................................................................................................................... 4-2

4.3 Querying and Obtaining Patient Information ...................................................................................................................................... 4-2

4.4 Associating Patient Information ................................................................................................................................................................ 4-2

4.5 Editing Patient Information ......................................................................................................................................................................... 4-3

4.6 Discharging a Patient .................................................................................................................................................................................... 4-3

4.7 Transferring Patient Data ............................................................................................................................................................................. 4-3

4.7.1 Transferring Patient Data via a USB Drive ................................................................................................................................ 4-4

4.7.2 Transferring Patient Data via the T1 to a Host Monitor ....................................................................................................... 4-5

4.8 Auto Deleting History Data from the SD Card ...................................................................................................................................... 4-5

4.9 Connecting to a CMS ..................................................................................................................................................................................... 4-6

5 Managing Configurations ................................................................................................................................................. 5-1

5.1 Introduction ...................................................................................................................................................................................................... 5-1

5.2 Accessing the [Manage Configuration] Menu ...................................................................................................................................... 5-2

5.3 Changing Department .................................................................................................................................................................................. 5-2

5.4 Setting Default Configuration .................................................................................................................................................................... 5-3

5.5 Saving Current Settings ................................................................................................................................................................................ 5-3

5.6 Editing Configurations .................................................................................................................................................................................. 5-4

5.7 Deleting a Configuration ............................................................................................................................................................................. 5-4

5.8 Transferring a Configuration ....................................................................................................................................................................... 5-4

5.9 Loading a Configuration .............................................................................................................................................................................. 5-5

5.10 Restoring the Latest Configuration Automatically .......................................................................................................................... 5-5

6 User Screens ....................................................................................................................................................................... 6-1

6.1 Adjusting the Screen Brightness ............................................................................................................................................................... 6-1

6.2 Adjusting Volume ........................................................................................................................................................................................... 6-1

6.3 Configuring Your Screens ............................................................................................................................................................................ 6-2

6.3.1 Changing the Waveform Line Size .............................................................................................................................................. 6-2

6.3.2 Changing Measurement Colors ................................................................................................................................................... 6-2

6.3.3 Choosing a Screen ............................................................................................................................................................................ 6-2

6.3.4 Changing the T1 Screen Layout ................................................................................................................................................... 6-3

6.3.5 Changing Screen Layout on the External Display ................................................................................................................. 6-4

6.4 Understanding the Big Numerics Screen ............................................................................................................................................... 6-5

6.5 Viewing Minitrends (Only Available with the External Display) ..................................................................................................... 6-5

2 T1 Patient Monitor Operator’s Manual

6.5.1 Having a Split-Screen View of Minitrends ................................................................................................................................ 6-6

6.5.2 Setting Minitrends ............................................................................................................................................................................ 6-7

6.6 Viewing OxyCRG (only available with the external display) ............................................................................................................ 6-7

6.7 Viewing Other Patients (Only Available with the External Display) .............................................................................................. 6-8

6.7.1 Care Group .......................................................................................................................................................................................... 6-8

6.7.2 Viewing the Care Group Overview Bar ...................................................................................................................................... 6-9

6.7.3 Understanding the View Other Patient Window ................................................................................................................... 6-9

7 Alarms ................................................................................................................................................................................ 7-1

7.1 Alarm Categories ............................................................................................................................................................................................ 7-1

7.2 Alarm Levels ...................................................................................................................................................................................................... 7-2

7.3 Alarm Indicators .............................................................................................................................................................................................. 7-2

7.3.1 Alarm Lamp ......................................................................................................................................................................................... 7-2

7.3.2 Alarm Messages ................................................................................................................................................................................ 7-2

7.3.3 Flashing Numeric .............................................................................................................................................................................. 7-3

7.3.4 Audible Alarm Tones ........................................................................................................................................................................ 7-3

7.3.5 Alarm Status Symbols ..................................................................................................................................................................... 7-4

7.4 Alarm Tone Configuration ........................................................................................................................................................................... 7-4

7.4.1 Setting the Minimum Alarm Volume ......................................................................................................................................... 7-4

7.4.2 Changing the Alarm Volume ........................................................................................................................................................ 7-4

7.4.3 Setting the Interval between Alarm Sounds .......................................................................................................................... 7-5

7.4.4 Changing the Alarm Tone Pattern .............................................................................................................................................. 7-5

7.4.5 Setting the Reminder Tones .......................................................................................................................................................... 7-6

7.5 Understanding the Alarm Setup Menu .................................................................................................................................................. 7-6

7.5.1 Setting Alarm Properties for All Parameters ........................................................................................................................... 7-7

7.5.2 Adjusting Alarm Limits Automatically ...................................................................................................................................... 7-7

7.5.3 Setting Alarm Delay Time ............................................................................................................................................................7-10

7.5.4 Setting SpO

2

Technical Alarm Delay ........................................................................................................................................7-10

7.5.5 Setting Recording Length ............................................................................................................................................................7-11

7.5.6 Entering CPB Mode (Cardiopulmonary Bypass Mode) .....................................................................................................7-11

7.6 Pausing Alarms ..............................................................................................................................................................................................7-11

7.7 Switching Off All Alarms .............................................................................................................................................................................7-12

7.8 Resetting Alarms ...........................................................................................................................................................................................7-12

7.9 Latching Alarms .............................................................................................................................................................................................7-13

7.10 Testing Alarms .............................................................................................................................................................................................7-14

7.11 Using Care Group Alarms (Only Available with the External Display) .....................................................................................7-14

7.11.1 Care Group Auto Alarms ............................................................................................................................................................7-14

7.11.2 Setting Care Group Alert Tone .................................................................................................................................................7-14

7.11.3 Resetting Care Group Alarms ...................................................................................................................................................7-15

8 Monitoring ECG ................................................................................................................................................................. 8-1

8.1 Introduction ...................................................................................................................................................................................................... 8-1

8.2 Safety ................................................................................................................................................................................................................... 8-1

8.3 Preparing to Monitor ECG ............................................................................................................................................................................ 8-2

8.3.1 Preparing the Patient and Placing the Electrodes ................................................................................................................ 8-2

8.3.2 Choosing AHA or IEC Lead Placement ...................................................................................................................................... 8-2


4

8.3.3 ECG Lead Placements ...................................................................................................................................................................... 8-3

8.3.4 Checking Paced Status .................................................................................................................................................................... 8-4

8.4 Understanding the ECG Display ................................................................................................................................................................ 8-5

8.5 Changing ECG Settings ................................................................................................................................................................................. 8-6

8.5.1 Accessing ECG Menus ..................................................................................................................................................................... 8-6

8.5.2 Setting Pacemaker Rate (For Mortara ECG Algorithm only) .............................................................................................. 8-6

8.5.3 Choosing the Alarm Source .......................................................................................................................................................... 8-6

8.5.4 Changing ECG Wave Settings ....................................................................................................................................................... 8-6

8.5.5 Changing the ECG Filter Settings ................................................................................................................................................ 8-7

8.5.6 Setting the ECG Lead Set ............................................................................................................................................................... 8-7

8.5.7 Choosing an ECG Display Screen ................................................................................................................................................ 8-7

8.5.8 Setting the Notch Filter .................................................................................................................................................................. 8-8

8.5.9 Changing the Pacer Reject Settings ........................................................................................................................................... 8-8

8.5.10 Enabling Smart Lead Off .............................................................................................................................................................. 8-8

8.5.11 Setting the Alarm Level for ECG Lead Off Alarms ............................................................................................................... 8-8

8.5.12 Adjusting QRS Volume ................................................................................................................................................................. 8-9

8.5.13 Adjusting the Minimum QRS Detection Threshold (For Advanced ECG Algorithm Only) ................................... 8-9

8.5.14 About the Defibrillator Synchronization .............................................................................................................................8-10

8.6 About ST Monitoring ...................................................................................................................................................................................8-10

8.6.1 Switching ST Monitoring On and Off ......................................................................................................................................8-11

8.6.2 Changing ST Filter Settings .........................................................................................................................................................8-11

8.6.3 Understanding the ST Display....................................................................................................................................................8-11

8.6.4 Saving the Current ST Segment as Reference ......................................................................................................................8-12

8.6.5 Changing the Reference Segment ...........................................................................................................................................8-12

8.6.6 Deleting a Reference Segment ..................................................................................................................................................8-12

8.6.7 Changing the ST Alarm Limits ....................................................................................................................................................8-12

8.6.8 Setting the ST Alarm Delay Time ...............................................................................................................................................8-12

8.6.9 Adjusting ST Measurement Points ...........................................................................................................................................8-13

8.7 QT/QTc Interval Monitoring (For Advanced ECG Algorithm Only) .............................................................................................8-14

8.7.1 QT/QTc Monitoring Limitations .................................................................................................................................................8-15

8.7.2 Enabling QT/QTc Monitoring ......................................................................................................................................................8-15

8.7.3 Displaying QT/QTc Parameters and Waveform ....................................................................................................................8-16

8.7.4 Accessing the QT View ..................................................................................................................................................................8-16

8.7.5 Changing QT Settings ...................................................................................................................................................................8-17

8.7.6 Changing QTc Formula .................................................................................................................................................................8-18

8.8 About Arrhythmia Monitoring .................................................................................................................................................................8-18

8.8.1 Understanding the Arrhythmia Events ...................................................................................................................................8-19

8.8.2 Changing Arrhythmia Alarm Settings .....................................................................................................................................8-21

8.8.3 Changing Arrhythmia Threshold Settings .............................................................................................................................8-21

8.8.4 Setting the Extended Arrhythmia (For Advanced ECG Algorithm Only) ....................................................................8-22

8.8.5 Reviewing Arrhythmia Events ....................................................................................................................................................8-22

8.9 ECG Relearning ..............................................................................................................................................................................................8-23

8.9.1 Initiating an ECG Relearning Manually ...................................................................................................................................8-23

8.9.2 Automatic ECG Relearning ..........................................................................................................................................................8-23

8.10 12-Lead ECG Monitoring .........................................................................................................................................................................8-24

8.10.1 Setting ECG Waveform Sequence ..........................................................................................................................................8-24


8.10.2 Extending the rhythm lead waveform area ........................................................................................................................8-24

8.11 Resting 12-Lead ECG Analysis ................................................................................................................................................................8-25

8.11.1 Accessing the 12-Lead Screen .................................................................................................................................................8-25

8.11.2 Entering Patient Information ...................................................................................................................................................8-25

8.11.3 12-Lead Setup ................................................................................................................................................................................8-26

8.11.4 Resting 12-lead ECG Analysis ...................................................................................................................................................8-28

8.11.5 12-lead ECG Report ......................................................................................................................................................................8-29

8.12 Troubleshooting .........................................................................................................................................................................................8-30

9 Monitoring Respiration (Resp) ......................................................................................................................................... 9-1

9.1 Introduction ...................................................................................................................................................................................................... 9-1

9.2 Safety Information .......................................................................................................................................................................................... 9-1

9.3 Understanding the Resp Display ............................................................................................................................................................... 9-1

9.4 Placing Resp Electrodes ................................................................................................................................................................................ 9-2

9.4.1 Optimizing Lead Placement for Resp ........................................................................................................................................ 9-2

9.4.2 Cardiac Overlay .................................................................................................................................................................................. 9-2

9.4.3 Abdominal Breathing ...................................................................................................................................................................... 9-3

9.4.4 Lateral Chest Expansion ................................................................................................................................................................. 9-3

9.5 Choosing the Respiration Lead .................................................................................................................................................................. 9-3

9.6 Changing the Apnea Alarm Delay ............................................................................................................................................................ 9-3

9.7 Changing Resp Detection Mode ............................................................................................................................................................... 9-3

9.8 Changing Resp Wave Settings ................................................................................................................................................................... 9-4

9.9 Setting Respiration Rate (RR) Source ....................................................................................................................................................... 9-4

9.10 Setting Alarm Properties ........................................................................................................................................................................... 9-5

10 Monitoring PR ............................................................................................................................................................... 10-1

10.1 Introduction .................................................................................................................................................................................................10-1

10.2 Setting the PR Source ...............................................................................................................................................................................10-1

10.3 Selecting the Active Alarm Source .......................................................................................................................................................10-2

10.4 QRS Tone ........................................................................................................................................................................................................10-2

11 Monitoring SpO

2

............................................................................................................................................................ 11-1

11.1 Introduction .................................................................................................................................................................................................11-1

11.2 Safety ..............................................................................................................................................................................................................11-2

11.3 Identifying SpO

2

Modules .......................................................................................................................................................................11-2

11.4 Applying the Sensor ..................................................................................................................................................................................11-2

11.5 Changing SpO

2

Settings ..........................................................................................................................................................................11-3

11.5.1 Accessing SpO2 Menus ..............................................................................................................................................................11-3

11.5.2 Adjusting the Desat Alarm ........................................................................................................................................................11-3

11.5.3 Setting SpO2 Sensitivity ............................................................................................................................................................11-3

11.5.4 Changing Averaging Time ........................................................................................................................................................11-3

11.5.5 Monitoring SpO2 and NIBP Simultaneously ......................................................................................................................11-4

11.5.6 Sat-Seconds Alarm Management ...........................................................................................................................................11-4

11.5.7 Changing the Speed of the Pleth Wave ...............................................................................................................................11-5

11.5.8 Zooming PI Value (Only Available with the External Display) ......................................................................................11-5

11.5.9 Setting the Alarm Level for SpO2 Sensor Off Alarm ........................................................................................................11-5


11.5.10 Setting the SpO2 Tone Mode ................................................................................................................................................11-5

11.6 Measurement Limitations .......................................................................................................................................................................11-6

11.7 Masimo Information ..................................................................................................................................................................................11-6

11.8 Nellcor Information ...................................................................................................................................................................................11-7

11.9 Troubleshooting .........................................................................................................................................................................................11-7

12 Monitoring NIBP ............................................................................................................................................................ 12-1

12.1 Introduction .................................................................................................................................................................................................12-1

12.2 Safety ..............................................................................................................................................................................................................12-2


12.4 Measurement Methods ............................................................................................................................................................................12-2

12.5 Setting Up the NIBP Measurement ......................................................................................................................................................12-3

12.5.1 Preparing the Patient ..................................................................................................................................................................12-3

12.5.2 Preparing to Measure NIBP .......................................................................................................................................................12-3

12.5.3 Starting and Stopping Measurements .................................................................................................................................12-4

12.5.4 Correcting the Measurement if Limb is not at Heart Level ..................................................................................................12-4

12.5.5 Enabling NIBP Auto Cycling and Setting the Interval .....................................................................................................12-4

12.5.6 Enabling Measurement on Clock ...........................................................................................................................................12-4

12.5.7 Starting a STAT Measurement ..................................................................................................................................................12-5

12.6 Understanding the NIBP Numerics ......................................................................................................................................................12-5

12.7 Changing NIBP Settings ...........................................................................................................................................................................12-6

12.7.1 Setting the Initial Cuff Inflation Pressure .............................................................................................................................12-6

12.7.2 Setting NIBP Alarm Properties .................................................................................................................................................12-6

12.7.3 Displaying NIBP List .....................................................................................................................................................................12-6

12.7.4 Setting the Pressure Unit ...........................................................................................................................................................12-6

12.7.5 Switching On NIBP End Tone ....................................................................................................................................................12-6

12.8 Assisting Venous Puncture ......................................................................................................................................................................12-7

13 Monitoring Temp ........................................................................................................................................................... 13-1

13.1 Introduction .................................................................................................................................................................................................13-1

13.2 Safety ..............................................................................................................................................................................................................13-1

13.3 Taking a Temp Measurement .................................................................................................................................................................13-1

13.4 Understanding the Temp Display .........................................................................................................................................................13-2

13.5 Setting the Temperature Unit ................................................................................................................................................................13-2

14 Monitoring IBP .............................................................................................................................................................. 14-1

14.1 Introduction .................................................................................................................................................................................................14-1

14.2 Safety ..............................................................................................................................................................................................................14-1

14.3 Zeroing the Transducer ............................................................................................................................................................................14-2

14.4 Setting Up the Pressure Measurement...............................................................................................................................................14-3

14.5 Understanding the IBP Display .............................................................................................................................................................14-4

14.6 Changing IBP Settings ..............................................................................................................................................................................14-4

14.6.1 Changing a Pressure for Monitoring .....................................................................................................................................14-4

14.6.2 Setting Alarm Properties ...........................................................................................................................................................14-5

14.6.3 Changing Averaging Time ........................................................................................................................................................14-5

14.6.4 Setting Up the IBP Wave ............................................................................................................................................................14-5


14.6.5 Setting the Pressure Unit ...........................................................................................................................................................14-5

14.6.6 Enabling PPV Measurement and Setting PPV Source .....................................................................................................14-5

14.7 Overlapping IBP Waveforms ...................................................................................................................................................................14-6

14.8 Measuring PAWP (Only Available with the External Display) .....................................................................................................14-7

14.8.1 Preparing to Measure PAWP .....................................................................................................................................................14-8

14.8.2 Setting Up the PAWP Measurement ......................................................................................................................................14-9

14.8.3 Understanding the PAWP Setup Menu ................................................................................................................................14-9

14.9 Troubleshooting ...................................................................................................................................................................................... 14-10

15 Monitoring CO

2

.............................................................................................................................................................. 15-1

15.1 Introduction .................................................................................................................................................................................................15-1

15.2 Identifying CO

2

Modules ..........................................................................................................................................................................15-2

15.3 Preparing to Measure CO

2

.......................................................................................................................................................................15-2

15.3.1 Making a Sidestream CO

2

Measurement .............................................................................................................................15-3

15.3.2 Making a Microstream CO

2

Measurement ..........................................................................................................................15-4

15.4 Changing CO

2

Settings .............................................................................................................................................................................15-4

15.4.1 Accessing CO

2

Menus .................................................................................................................................................................15-4

15.4.2 Setting the CO

2

Unit ....................................................................................................................................................................15-4

15.4.3 Setting Up Gas Compensations ..............................................................................................................................................15-4

15.4.4 Setting Up Humidity Compensation .....................................................................................................................................15-5

15.4.5 Setting the Apnea Alarm Delay ...............................................................................................................................................15-5

15.4.6 Choosing a Time Interval for Peak-Picking ..........................................................................................................................15-6

15.4.7 Setting the Flow Rate ..................................................................................................................................................................15-6

15.4.8 Setting Up the CO2 Waveform ................................................................................................................................................15-6

15.4.9 Setting RR Source .........................................................................................................................................................................15-6

15.4.10 Barometric Pressure Compensation....................................................................................................................................15-7

15.4.11 Entering the Standby Mode ...................................................................................................................................................15-7


15.6 Leakage test .................................................................................................................................................................................................15-8

15.7 Troubleshooting the Sidestream CO2 Sampling System .............................................................................................................15-8

15.8 Removing Exhaust Gases from the System ......................................................................................................................................15-9

15.9 Zeroing the Sensor ....................................................................................................................................................................................15-9

15.10 Calibrating the Sensor ............................................................................................................................................................................15-9

15.11 Oridion Information ............................................................................................................................................................................. 15-10

16 Review ............................................................................................................................................................................ 16-1

16.1 Accessing Respective Review Windows .............................................................................................................................................16-1

16.2 Reviewing Graphic Trends.......................................................................................................................................................................16-1

16.3 Reviewing Tabular Trends ........................................................................................................................................................................16-2

16.4 Reviewing Events .......................................................................................................................................................................................16-3

16.4.1 Marking Events ..............................................................................................................................................................................16-3

16.4.2 Reviewing Events .........................................................................................................................................................................16-3

16.5 Reviewing Waveforms ..............................................................................................................................................................................16-5

16.6 Reviewing OxyCRG (Only Available with the External Display) .................................................................................................16-5

17 Calculations (Only Available with the External Display) ............................................................................................ 17-1


17.1 Introduction .................................................................................................................................................................................................17-1

17.2 Dose Calculations .......................................................................................................................................................................................17-2

17.2.1 Performing Calculations ............................................................................................................................................................17-2

17.2.2 Selecting the Proper Drug Unit ...............................................................................................................................................17-2

17.2.3 Titration Table ................................................................................................................................................................................17-3

17.2.4 Drug Calculation Formulas .......................................................................................................................................................17-3

17.3 Oxygenation Calculations .......................................................................................................................................................................17-3


17.3.2 Entered Parameters .....................................................................................................................................................................17-4

17.3.3 Calculated Parameters and Formulas ...................................................................................................................................17-4

17.4 Ventilation Calculations ...........................................................................................................................................................................17-5




17.5 Hemodynamic Calculations ...................................................................................................................................................................17-6




17.6 Renal Calculations ......................................................................................................................................................................................17-8




17.7 Understanding the Review Window ...................................................................................................................................................17-9

18 Printing .......................................................................................................................................................................... 18-1

18.1 Printer .............................................................................................................................................................................................................18-1

18.2 Connecting a printer .................................................................................................................................................................................18-1

18.3 Setting the Printer ......................................................................................................................................................................................18-1

18.4 Starting Report Printouts ........................................................................................................................................................................18-2

18.5 Stopping Report Printouts ......................................................................................................................................................................18-2

18.6 Setting Up Reports ....................................................................................................................................................................................18-2

18.6.1 Setting Up ECG Reports .............................................................................................................................................................18-2

18.6.2 Setting Up Tabular Trends Reports ........................................................................................................................................18-3

18.6.3 Setting Up Graphic Trends Reports .......................................................................................................................................18-3

18.6.4 Setting Up Realtime Reports ....................................................................................................................................................18-3

18.7 End Case Reports ........................................................................................................................................................................................18-3

18.8 Printer Statuses ...........................................................................................................................................................................................18-4

18.8.1 Printer Out of Paper .....................................................................................................................................................................18-4

18.8.2 Printer Unavailable ......................................................................................................................................................................18-4

19 Other Functions ............................................................................................................................................................. 19-1

19.1 Analog Output.............................................................................................................................................................................................19-1

19.2 Exporting the Log ......................................................................................................................................................................................19-1

19.3 Using the Storage Card ............................................................................................................................................................................19-1

19.4 Transferring Data ........................................................................................................................................................................................19-2

19.4.1 Data Export System .....................................................................................................................................................................19-2


19.4.2 Transferring Data by Different Means ...................................................................................................................................19-2

19.5 Network Setup ............................................................................................................................................................................................19-3

19.5.1 Setting the Network Type ..........................................................................................................................................................19-3

19.5.2 Wireless Network Connection .................................................................................................................................................19-3

19.5.3 Certificates Maintenance ...........................................................................................................................................................19-5

19.5.4 Setting the Central Stations......................................................................................................................................................19-5

19.5.5 Setting the Network Service Quality Level .........................................................................................................................19-6

19.5.6 Setting the Multicast Parameters ...........................................................................................................................................19-6

20 Battery ........................................................................................................................................................................... 20-1

20.1 Overview .......................................................................................................................................................................................................20-1

20.2 Safety ..............................................................................................................................................................................................................20-2

20.3 Battery Guidelines ......................................................................................................................................................................................20-2

20.4 Installing or Replacing a Battery ...........................................................................................................................................................20-3

20.5 Charging a Battery .....................................................................................................................................................................................20-3

20.6 Conditioning a Battery .............................................................................................................................................................................20-4

20.7 Checking Battery Performance .............................................................................................................................................................20-5

20.8 Storing a Battery .........................................................................................................................................................................................20-5

20.9 Recycling Batteries .....................................................................................................................................................................................20-6

21 Care and Cleaning ......................................................................................................................................................... 21-1

21.1 General Points .............................................................................................................................................................................................21-1

21.2 Cleaning .........................................................................................................................................................................................................21-2

21.3 Disinfecting ..................................................................................................................................................................................................21-3

21.4 Sterilization ...................................................................................................................................................................................................21-3

22 User Maintenance ......................................................................................................................................................... 22-1

22.1 General Inspection .....................................................................................................................................................................................22-1

22.2 Maintenance and Testing Schedule.....................................................................................................................................................22-2

22.3 Checking Monitor and Module Information ....................................................................................................................................22-3

22.4 ECG Verification ...........................................................................................................................................................................................22-3

22.5 NIBP Leakage Test ......................................................................................................................................................................................22-3

22.6 CO

2

Leakage Test ........................................................................................................................................................................................22-4

22.7 Calibrating the Touchscreen ...................................................................................................................................................................22-5

23 Accessories..................................................................................................................................................................... 23-1

23.1 ECG Accessories ..........................................................................................................................................................................................23-1

23.2 SpO

2

Accessories ........................................................................................................................................................................................23-3

23.3 NIBP Accessories .........................................................................................................................................................................................23-4

23.4 Temp Accessories .......................................................................................................................................................................................23-5

23.5 IBP Accessories ............................................................................................................................................................................................23-6

23.6 CO

2

Accessories ...........................................................................................................................................................................................23-6

23.7 Mount and Mounting Accessories .......................................................................................................................................................23-7

23.8 Miscellaneous Accessories ......................................................................................................................................................................23-7

A Product Specifications ...................................................................................................................................................... A-1


A.1 Classifications ..................................................................................................................................................................................................A-1

A.2 Environmental Specifications ....................................................................................................................................................................A-1

A.3 Power Supply Specifications ......................................................................................................................................................................A-2

A.4 Physical Specifications ..................................................................................................................................................................................A-3

A.5 Hardware Specifications ..............................................................................................................................................................................A-3

A.6 Data Storage.....................................................................................................................................................................................................A-5

A.7 Wireless Network ............................................................................................................................................................................................A-5

A.8 Measurement Specifications ......................................................................................................................................................................A-6

B EMC and Radio Regulatory Compliance .......................................................................................................................... B-1

B.1 EMC ...................................................................................................................................................................................................................... B-1

B.2 Radio Regulatory Compliance ................................................................................................................................................................... B-6

B.3 Radio Frequency Radiation Exposure Information ............................................................................................................................ B-6

C Default Configurations ..................................................................................................................................................... C-1

C.1 Parameters Configuration ........................................................................................................................................................................... C-1

C.2 Routine Configuration ............................................................................................................................................................................... C-11

C.3 User Maintenance Items ........................................................................................................................................................................... C-14

D Alarm Messages ............................................................................................................................................................... D-1

D.1 Physiological Alarm Messages ................................................................................................................................................................. D-1

D.2 Technical Alarm Messages ......................................................................................................................................................................... D-3

E Symbols and Abbreviations ............................................................................................................................................. E-1

E.1 Symbols .............................................................................................................................................................................................................. E-1

E.2 Abbreviations ................................................................................................................................................................................................... E-2


1

Safety

1.1 Safety Information

WARNING



Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION



Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE



Provides application tips or other useful information to ensure that you get the most from your product.

T1 Patient Monitor Operator’s Manual 1-1

1.1.1 Warnings

WARNINGS

1-2











Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.



To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. If a properly grounded power outlet is not available, operate the monitor on battery power.

The equipment is not intended to be used within the Magnetic Resonance (MR) environment.

Ensure that the patient monitor is supplied with continuous electric power during work. Sudden power failure may lead to data loss.



To avoid an explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).



Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.



Do not open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by Mindray only.

Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.

Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring.



PATIENTS WITH A PACEMAKER – On ventricular paced patients, episodes of Ventricular Tachycardia may not always be detected. Do not rely entirely upon the system’s automated arrhythmia detection algorithm.

Keep pacemaker patients under close surveillance.



The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation.



To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel.



Do not touch the equipment’s metal parts or connectors when in contact with the patient; otherwise patient injury may result.



Never mix patient electrode types or brands. Dissimilar metals or other incompatibilities may cause considerable baseline drift and may increase trace recovery time after defibrillation.



To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitor’s cables and transducers never come into contact with the electro-surgery unit (ESU).



The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result.



Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phones and X-ray equipment are a possible source of interference as they may emit higher levels of electromagnetic radiation.


1.1.2 Cautions

CAUTIONS





Only use parts and accessories specified in this manual.





Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.







Always install or carry the equipment properly to avoid damage caused by a drop, impact, strong vibration or other mechanical force.

Dry the equipment immediately in case of rain or water spray.

When no battery is installed, ensure that the monitor is supplied with continuous electric power during operation. Sudden power failure may lead to data loss.

This equipment is intended for single patient use.

Store and use the equipment in specified environmental condition. The monitor and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.



Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

1.1.3 Notes

NOTES



Put the equipment in a location where you can easily view and operate the equipment.



During normal use, the operator is expected to face the front of the equipment.



The equipment uses a mains plug as a means of isolation to the mains power supply. Do not position the equipment in a place difficult to operate the mains plug.



Remove the battery before shipping the monitor or if it will not be used for an extended period of time.



Keep this manual in the vicinity of the equipment so that it can be conveniently referenced when needed.



The software was developed in compliance with IEC60601-1-4. Therefore, The possibility of hazards arising from software errors is minimized.



This manual describes all features and options. Your equipment may not have all of them. They are not available in all geographies.



Remove the battery before shipping the monitor or if it will not be used for an extended period of time.



At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray.



When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.


1.2 Equipment Symbols

Some symbols may not appear on your equipment.

ON/OFF for a part of equipment

Battery indicator

Multifunctional connector

Unlocking

VGA connector

Lock; tighten

Direct current

Network connector

Serial number

Equipotentiality

Direction and angle of rotation

Alternating current

Date of Manufacture Symbol for “MANUFACTURER”

Input/output

Protected against vertically falling water drops per IEC 60529

Defibrillation-proof Type CF applied part

USB connector

Protected against vertically falling water drops when ENCLOSURE tilted up to 15° per

IEC 60529

Defibrillation-proof Type BF applied part

General warning sign Refer to instruction manual/ booklet

The presence of this label indicates the machine was certified by ETL with the statement:

Conforms to AAMI Std. ES 60601-1, IEC Std. 60601-1-6, IEC Std. 60601-1-8, IEC Std. 60601-2-25, IEC Std.

60601-2-27, IEC Std. 60601-2-34, IEC Std. 60601-2-49, IEC Std. 80601-2-30, ISO Std. 80601-2-55, ISO Std.

80601-2-56, ISO Std. 80601-2-61

Certified to CSA Std. C22.2 NO. 60601-1, NO. 60601-1-6, NO. 60601-1-8, NO. 60601-2-25, NO.

60601-2-27, NO. 60601-2-34, NO. 60601-2-49, NO. 80601-2-30, NO. 80601-2-55, NO. 80601-2-56, NO.

80601-2-61

1-4 T1 Patient Monitor Operator’s Manual

2

The Basics

2.1 Monitor Description

2.1.1 Intended Use

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis , and heart rate (HR), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO

2

), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure

(PAWP), and carbon dioxide (CO

2

). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

 The arrhythmia detection, ST Segment analysis of Mortara ECG algorithm, and PAWP monitoring are intended for adult and pediatric patients.

 ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

WARNING



This patient monitor is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on it.

NOTE



Mindray ECG algorithm is hereinafter referred as the Advanced ECG algorithm.


2.1.2 Equipment Features

The monitor is intended to be used in a hospital environment including, but not limited to, ICU, CCU, PICU, NICU, RICU, emergency room, operating room, postoperative observation ward, etc.

The monitor can be used in two ways:

 As a stand-alone patient monitor, or

 As a multi-parameter module (MPM) for the Mindray Passport 17M and Passport 12M patient monitors, hereafter referred to as “the host monitor”.

In this manual, the T1 is generally referred to as “the monitor” except in the situation describing its use with a host monitor, where it is referred to as “the T1” to distinguish it from the host monitor.

2.1.3 Applied Parts

The applied parts of the equipment are:

 ECG electrodes and leadwires

 SpO

2

sensor

 NIBP cuff

 Temp probes

 IBP: IBP transducer

 CO

2

sampling line/nasal sampling cannula, and water trap


2.2 Equipment Description

2.2.1 Main Unit

2.2.1.1 Front View

1

2

3

4

5

6

7

When a physiological alarm or technical alarm occurs, this lamp flashes as defined below.



High level alarms: the lamp quickly flashes red.



Medium level alarms: the lamp slowly flashes yellow.



Low level alarms: the lamp lights yellow without flashing.

3. Ambient light sensor strength of ambient light.

4. External power supply indicator



On: when external DC power supply is connected.



Off: when external DC power supply is disconnected.



On: when the battery is installed and the external DC power supply is connected.



Off: when no battery is installed, or the installed battery is malfunctioning, or no external DC power supply is connected when the monitor is powered off.



Flashing: when the monitor operates on battery power.

6. Power On/Off Switch



Pressing this switch turns the monitor on.



When the monitor is on, pressing and holding this switch turns the monitor off.

An indicator is built into this switch. It turns on when the monitor is on and turns off when the monitor is off.




When the T1 is not connected with the external display, sliding this switch to the right locks/unlocks the touch screen.



When the T1 is connected to the external display, sliding this switch to the right switches screen display between the T1 and the external display.

2.2.1.2 Left View

1

2

2-4

3

4

4

1. External DC power supply connector

2. Main unit multi-pin connector: connects the T1 to the T1 handle or T1 docking station.

3. Infrared filter: used for communication between the T1 and host monitor.

4. Contact: connects power to the T1 from the T1 docking station or the host monitor.

NOTE



To ensure good contact, clean the contacts regularly, as dust and dirt may collect on them. When cleaning the contacts, wipe them with cotton, dampened with alcohol. Using forceps is recommended.


2.2.1.3 Right View

1 2

3

5

6

4

7

8

1. Temp probe 1 connector

2. Temp probe 2 connector

3. IBP cable connector

4. Multifunctional connector: outputs analog ECG, IBP and defibrillation synchronization signals.

5. NIBP cuff connector

6. ECG cable connector

7. SpO

2

cable connector

8. Speaker

2.2.1.4 Bottom View

1

2

1. Latch: locks the T1 when the T1 is in use with the host monitor, the T1 docking station, or the T1 handle. Pressing here releases the T1 so that you can remove it from the host monitor, the T1 docking station, or the T1 handle.


2.2.2 T1 handle

The T1 handle is used to connect a T1 and an external parameter module as well as providing bed rail mounting capability. It can also be connected to the T1 docking station.

2.2.2.1 Left View

1

2

1. Release button: pressing this button releases the T1 handle from the T1 docking station.

2. T1 handle multi-pin connector 1: connects the T1 handle and T1 docking station.


1

2

3

2-6

T1 handle multi-pin connector 2: connects the T1 handle and the T1.

2. Infrared filter: used for communication between the T1 handle and external parameter module.

3. Contact: power input connector of the external parameter module.


2.2.3 T1 Docking Station

The T1 docking station is used to connect the T1 or T1 handle to provide power, charge the installed battery, and support connection to an external display, USB drive, network cables, and the Passport 12M/17M patient monitors.

2.2.3.1 Left View

1

2

3

4

1. Symbol: indicates the direction and angle that the T1 docking station can rotate when the T1 docking station is fixed onto a transverse or a vertical rod.

2. Pole mount seat: used to fix the pole mount to the docking station and then to a transverse or a vertical rod.


1

3

2

1. T1 docking station multi-pin connector: power input and communication connector for the T1

2. Connection status indicator: it is on when the T1 is properly connected to the T1 docking station.

3. External power supply indicator: it is on when the external AC power supply is connected.


2.2.3.3 Rear View

1. AC power input

1 2 3 4

5

6

2. Equipotential grounding terminal

When using the monitor together with other devices, connect their equipotential grounding terminals together to eliminate the potential differences between them.

3. VGA connector: connects the external display

4. External device connector: connects the T1 to the host monitor through a cable.

5. USB connector: connects USB devices, including the USB drive, mouse and keyboard.

6. Network connector: a standard RJ45 connector which connects the monitor to the CMS or CIS. It can also be used to transfer data.

2.2.4 External Parameter Modules

The monitor can connect the following external parameter modules to perform CO

2

monitoring through the T1 handle.

2-8

Sidestream CO

2

module Microstream CO

2

module


2.3 Installation

The T1 handle and T1 docking station are part of the equipment. Use only the specified T1 handle and T1 docking station.

2.3.1 T1 in Use with the T1 Handle

You can install the T1 and an external parameter module, if needed, to the T1 handle as indicated below:

You hear a click when the T1 or the external module is pushed into place.

CAUTION



When the external module is properly installed, you should further fasten the module to the T1 handle with the lock at the bottom of the module to ensure the engagement.

To remove the T1 or external parameter module:

1. Press and hold the latch at the bottom of the T1 or parameter module. If the external module is locked to the T1 handle, unlock it first.

2. Pull the T1 or parameter module out as indicated below.


CAUTION



To prevent the T1 from falling out, do not press the release button while transporting the T1 with the T1 handle.

2.3.2 T1 Handle in Use with the T1 Docking Station

The T1 handle can be installed into the T1 docking station as indicated below:

You hear a click when the T1 handle is pushed into place.

To remove the T1 handle:

1. Press and hold down the release button at the top of the T1 handle.

2. Pull the T1 handle out as indicated.


2.3.3 T1 in Use with the T1 Docking Station

You can also install the T1 directly to the T1 docking station as indicated below:

You hear a click when the T1 is pushed into place.

To remove the T1 from the T1 docking station:

1. Press and hold the latch at the bottom of the T1.

2. Pull the T1 out as indicated below.


2.4 Display Screen

This monitor uses a high-resolution TFT LCD to display patient parameters and waveforms. A typical display screen is shown below.

1

2

3

2-12

4

6

5

2. Patient Information/Technical Alarm Area



This area shows the patient information such as department, bed number, patient name, patient category and paced status. indicates that the patient has an implanted pacemaker. If no patient is admitted, selecting this area enters the [Patient Setup] menu. For admitted patients, selecting this area enters the [Patient

Demographics] menu.



When a technical alarm is presented, patient information will be covered by the technical alarm message.

When multiple alarms occur, they scroll. Selecting this area shows the Technical Alarms list.

3. Physiological Alarm Area

This area shows physiological alarm messages. When multiple alarms occur, the messages scroll. Select this area and the physiological alarms list displays.

4. Waveform Area and Parameter Area A

The left side of this area shows measurement waveforms. The right side of this area shows corresponding measurement parameters. Select this area and the corresponding measurement setup menu displays.

5. Parameter Area B

For the parameter values displayed in this area, their corresponding waveforms are not displayed.


This area contains QuickKeys that provides quick access to functions.

Start or stop NIBP measurements

Reset the alarms

Enter/Exit the alarm paused state

Enter the main menu if no menu is currently displayed. If a menu is didsplayed on the screen, pressing it closes that menu.

7. Prompt Message Area

This area shows the current configuration name and prompt messages.

8. CMS status area

If the [Select CMS] function is enabled, this area shows the currently selected CMS. If no CMS is selected, this area displays “???”. Refer to section 19.5.4.1 Selecting a CMS for detail.

This area shows network status, battery status, and system time.



indicates the monitor is successfully connected to a wired network.



indicates the monitor has failed to connect to a wired network.



indicates the wireless function (optional) is connected.



indicates the wireless function (optional) is not connected.



indicates a USB drive is inserted.

For details about battery status symbols, refer to chapter 20 Battery.


FOR YOUR NOTES


3

Basic Operations

3.1 Installation

WARNING



Connect only approved devices to this equipment. Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the equipment’s signal input/output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact Mindray.



If it is not evident from the equipment specifications whether a particular combination with other devices is hazardous, for example, due to summation of leakage currents, please consult the manufacturers or else an expert in the field, to ensure the necessary safety of patients and all devices concerned will not be impaired by the proposed combination.

CAUTION



The equipment should be installed by Mindray authorized personnel .

NOTE



The software equipment copyright is solely owned by Mindray. No organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.



Many settings in the patient monitor are password protected. It is recommended to change the default passwords and keep the passwords safe. Passwords should only be changed by authorized personnel.

Contact your department manager or biomedical engineering department for the passwords used at your facility.


3.1.1 Unpacking and Checking

Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or Mindray.

If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact Mindray in case of any problems.

CAUTION



When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.



Before use, please verify whether the packages are intact, especially the packages of single use accessories.

In case of any damage, do not apply it to patients.

NOTE



Save the packing case and packaging material as they can be used if the equipment must be reshipped.

3.1.2 Environmental Requirements

The equipment operating environment must meet the requirements specified in this manual.

The equipment operating environment should be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. To maintain good ventilation, the equipment should be at least 2 inches (5 cm) away from surrounding objects.

When the equipment is moved from one place to another, condensation may occur as a result of temperature or humidity differences. In this case, never start the system before the condensation evaporates.

CAUTION



Make sure that the equipment operating environment meets the specific requirements. Otherwise un expected consequences, e.g. damage to the equipment, could result.


3.2 Getting Started

3.2.1 Connecting to Power Source

Using DC Power Adapter

To connect to the AC mains using the DC power adapter, connect one end of the power cord of the adapter with the DC power input on the equipment’s back panel and the other end with a wall AC mains outlet.

Using the T1 Docking Station

To connect to the AC power using the T1 docking station:

1. Install the monitor to the T1 docking station as described in section 2.3.3 T1 in Use with the T1 Docking Station.

2. Connect one end of the supplied power cord with the AC power input on the back of the T1 docking station and the other end with a wall AC mains outlet.

WARNING





Always use the accompanying power cord with the monitor.

Use the battery if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt.

Using a Battery

This monitor can be equipped with rechargeable lithium-ion battery. If a battery is installed, the monitor system automatically switches to the battery for power if AC power is interrupted.

NOTE



When a battery has been stored for a long time, or the battery is depleted, recharge the battery at once.

Otherwise, the low battery may not be sufficient to power the monitor if the AC power is unavailable.

Refer to chapter 20 Battery for detail.

Connecting Accessories

Insert the connector of accessory cables necessary for the measurements to be performed by your monitor to the corresponding connector on the monitor. For details about the parameter connectors, refer to section 2.2.1.3Right

View.


3.2.2 Turning Power On

Once the monitor is installed, before beginning measurements:

1. Check the monitor for any mechanical damage, and make sure that all external cables, plug-ins and accessories are properly connected.

2. Check the power supply specifications are met if mains power is used. Only use a power outlet that is properly grounded.

3. Connect the power source:



If you are using the DC adapter, plug the DC adapter into the T1.



If you run the monitor on battery power, install the battery and ensure that the battery is sufficiently charged.



If you are using the T1 docking station, install the T1 to the docking station and connect the docking station to the AC power.

4. Press the power on/off switch on the monitor’s front panel.

The monitor will perform alarm system self-test during start-up. After pressing the power on/off button, the system shows a “Loading…” screen, sounds a beep and the alarm lamp simultaneously turns yellow, then red, and then turns off, followed by the start-up screen being shown. Then the start-up screen disappears. The alarm system self-test succeeds. The monitor enters the normal monitoring screen.

WARNING



Do not use the monitor on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or Mindray.

NOTE



Carefully check if the system performs the self-test as described above. Contact your service personnel or

Mindray if the self-test is abnormal.

3.2.3 Starting Monitoring

To start monitoring,

1. Decide which measurements you want to take.

2. Connect the required modules, patient cables, and sensors.

3. Make sure that the patient cables and sensors are correctly connected.

4. Make sure that the patient settings such as [Patient Cat.], [Paced], etc., are appropriate for your patient.

5. Refer to the appropriate measurement section for details of how to perform the measurements you require.


3.3 Turning Off the Monitor

Before turning off the monitor:

1. Ensure that the monitoring of the patient has been completed.

2. Disconnect the cables and sensors from the patient.

3. Make sure to save or clear the patient monitoring data as required.

4. Press and hold the power on/off switch to turn off the monitor. “System is shutting down…” is displayed on the screen and then the monitor shuts down.

CAUTION



Press and hold the power on/off switch for 10 seconds to forcibly shut down the monitor if it could not be shut down normally. This may cause loss of patient data.



The monitor restores the latest configuration if it restarts within 60 seconds after the power failure. And it will restore the default configuration rather than the latest configuration if it restarts 120 seconds after the power failure. The monitor loads either the latest configuration or the default configuration if it restarts from 60-120 seconds after the power failure.



Power failure may cause data corruption on the SD card. It is recommended to turn off the monitor according to the normal procedures. Do not directly unplug the power cord, unless a charged battery is installed, or remove the battery before shutting down the monitor.

NOTE



To completely disconnect the power supply, unplug the power cord and then remove the battery.

3.4 Using the Touchscreen

Select screen items by touching them directly on the monitor’s screen.

To avoid misuse, you can lock the touchscreen. If the touchscreen is locked, a message [Screen locked. Please move

the lock/unlock key to unlock the screen] is displayed. The touchscreen is locked automatically if no operation is detected within 60 seconds.

If the screen is locked, a symbol right unlocks the screen.

is shown in the Main Menu QuickKey area. Sliding the lock/unlock key to the


3.5 Using the On-Screen Keyboard

The onscreen keyboard enables you to enter information.

 Use the

key to delete the previously entered character.

 Use the

key to toggle between uppercase and lowercase letters.

 Select

 Select

to confirm what you have entered and close the onscreen keyboard.

to access the symbol keyboard.

 Select

to exit the symbol keyboard.

3.6 Using the External Display

The T1 can be connected to an external display through the VGA connector on the T1 docking station. When the external display is connected, you can monitor a patient either through the T1 or through the external display. Sliding the lock/unlock switch to the right can switch screen display between the T1 and the external display.

The external display displays different information than the T1 because the external display has a larger screen size. You can view or operate the following screens or functions only on the external display:

 Minitrends Screen

 OxyCRG Screen

 View Others Screen

 ECG 7-Lead Half-Screen

 PAWP Screen

 Calculations

To connect the external display:

1. Connect one end of the VGA cable to the VGA connector on the T1 docking station and the other end to the external display.

2. Connect the external display to the AC mains and turn on the display.

3. Connect the T1 to the T1 docking station.

Then you can use the external display to show information from the T1. You can adjust the display by pressing the Auto

Set key on the external display if image offset occurs.

To switch between the T1 and the external display, move the Lock/Unlock switch on the front panel of the T1.

Unplugging the VGA cable of a working external display may result in abnormity. If a problem occurs, remove the T1 from the docking station and reconnect it.


CAUTION



Only use the display specified by Mindray. Using an unspecified display may result in unknown problems.

3.7 Using the Mouse and Keyboard

When connected to the external display, the T1 can connect a mouse and a keyboard through the USB connector of the

T1 docking station. When a mouse is in use, only the left mouse-button can be used. The right mouse-button is disabled.

3.8 Using the Main Menu

To enter the [Main Menu], select the on-screen QuickKey. Most of monitor operations and settings can be performed through this menu.

1

3

2

4

Other menus are similar to the [Main Menu] and contain the following parts:

1. Heading: describes the current menu.

2. Main body: displays options, buttons, prompt messages, etc. The menu button with “>>’’ incorporates a secondary window to reveal more options or information.

3. : select to exit the current menu. If changes are made in the menu, they take effect after selecting this button.

4. and : moves to the next page or previous page to reveal more options or information.


3.9 Changing General Settings

3.9.1 Setting Up a Monitor

To install a monitor or change its location:

2. In the [User Maintenance] menu, enter the [Monitor Name], [Department] and [Bed No.].

You can set [Changing Bed No.] to:

 [Unprotected]: enables you to change Bed No. in the [Patient Demographics] menu.

 [Protected]: disables you from changing the Bed No. in the [Patient Demographics] menu.

3.9.2 Changing Language

To change the language:

2. In the [User Maintenance] menu, select [Language] and then select the desired language.

3. Restart the monitor.

NOTE



The changed language is applied only after the monitor is restarted.

3.9.3 Setting the Date and Time

To set the date and time:

2. Set the date and time.

If your monitor is connected to a central station (CMS), the date and time are automatically synchronized to that CMS. In that case, you cannot change the date and time settings on your monitor.

CAUTION



Changing date and time affects the storage of trends and events and may cause data loss. Save or record any needed data prior to changing the date and time.


3.9.4 Setting the Docking Station

To make sure that the T1 can be used with the docking station for the patient transfer, you need to configure the docking station on the T1.

To configure the docking station, select [Main Menu]→[Maintenance >>]→[User Maintenance >>]→enter the required password→[Others >>]→[Dock Setup >>].

NOTE



The dock setup function is active only when the T1 is inserted into the docking station.

Setting the Work Mode

Work mode defines the source of department, bed number, and central station IP information when the T1 is connected with the docking station.

 In Dock mode, the T1 uses the settings of the T1 when the T1 is connected, and the settings on the docking station remain unchanged whether the T1 is connected or removed.

 In host mode, the T1 uses the settings of the docking station when the T1 is connected, and the settings of the T1 when the T1 is removed from the docking station.

NOTE



The Work mode is from the perspective of the docking station. When [Dock Mode] is selected, the docking station works only as a Dock. When [Host Mode] is selected, the docking station acts as the Host.

Setting Network Type

Network Type specifies the source of the T1’s network configuration when the T1 is connected with the docking station.

 If [Use Current T1 Net Setting] is selected, the T1’s network setting is the current T1’s network setting when the T1 is connected, and the setting does not change when the T1 is removed from the docking station.

 If [Use Current Dock Net Setting] is selected, the T1’s network setting is the current network setting of the docking station, and the setting is restored to the previous T1’s settings when the T1 is removed from the docking station.


Setting the IP for CMS

The IP of the CMS defines the IP address of the CMS to which the T1 is connected. The T1 can only be connected to the specified CMS.

The IP address of the current CMS is shown in the prompt message area. You can select this area to pop up the [Central

Station IP] menu.

NOTE



For the DPM Central Station with system software version 01.01.00 or greater, as long as a patient is admitted, the T1 can be automatically connected to DPM Central Station.



For the Panorama Central Station with a system software version 11.5 or greater, as long as the device ID of the T1 has been added to the equipment list and a patient is admitted, the T1 can be connected to

Panorama Central Station.

3.10 Setting Parameters

3.10.1 Switching the Parameters On/Off

To switch the parameters on or off, select [Main Menu]→[Screens]→[Parameters Switch]. When a parameter is switched off, its corresponding parameter module stops working, and its parameter value and waveform are not shown on the monitor display.

NOTE



ECG is always selected, and you cannot switch it off.

3.10.2 Accessing the Parameters Menu

Select [Parameters >>] from the [Main Menu] or select corresponding parameter area or waveform area to access a parameter setup menu.

3.11 Operating Modes

Your monitor has different operating modes. Some are password protected. This section lists the major operating modes.

3.11.1 Monitoring Mode

This is the standard working mode that you use for monitoring patients. Your monitor automatically enters the

Monitoring mode after being turned on.


3.11.2 Night Mode

To avoid disturbing the patient, the Night mode may be used.

To activate the Night mode:

2. In the pop-up menu, set the desired brightness, alarm volume, QRS volume, key volume, NIBP end tone, and whether to stop NIBP measurements or not. When [Stop NIBP] is selected, all the NIBP measurements terminate after entering the Night mode.

3. Select the [Enter Night Mode] button.

To cancel the Night mode:

CAUTION



Before entering Night mode, confirm the brightness settings, alarm volume, QRS volume, and key volume. Consider the potential risk when the setting value is low.

3.11.3 Privacy Mode

The Privacy mode is available only when an admitted patient at a monitor is also monitored by the CMS.

To activate the Privacy mode, select [Main Menu]→[Screen Setup >>]→[Privacy Mode].

The monitor does the following after activating the Privacy mode:

 The screen turns blank and the message [Under monitoring. Press any key to exit the Privacy mode] displays.

 Monitoring and data storing continue but patient data is only visible at the CMS.

 Alarms can still be triggered. But all audible alarms are suppressed and the alarm light is deactivated at the monitor.

 All system sounds are suppressed, including heart beat tone, pulse tone, all prompt tones, etc.

To cancel the Privacy mode, press any key.

The monitor exits the Privacy mode automatically in any of the following situations:

 The monitor disconnects from the CMS.

 The alarm [Battery Too Low] or [System will shut down soon. Please replace the batteries or use the external

power] is presented.

The touchscreen is locked automatically in the Privacy mode.


WARNING



In the Privacy mode, all audible alarms are suppressed and the alarm light is deactivated at the monitor.

Alarms sound only at the CMS.

NOTE



The Privacy mode can be used only when the monitor is connected to a CMS.

3.11.4 Outdoor Mode

The Outdoor mode is intended for transporting patients in bright ambient light conditions. In this mode, the parameter color is white and unchangeable, and the screen brightness automatically changes to 10, the brightest.

To activate the Outdoor mode, select [Main Menu]→[Outdoor Mode].

You can also select [Main Menu]→[Maintenance >>]→[User Maintenance >>]→enter the required password. In the

[Others >>] menu, set [Outdoor Mode] to:



[Manual]: the monitor enters the Outdoor mode by manually selecting [Main Menu → [Outdoor Mode], or



[Auto]: the monitor enters the Outdoor mode automatically if the strength of ambient light is greater than the threshold for more than 5 seconds.

To exit Outdoor mode, select [Main Menu]→[Outdoor Mode]. The monitor automatically exits the Outdoor mode when:



The T1 is connected to a host monitor.



The strength of ambient light is lower than the threshold for more than 5 seconds and the [Outdoor Mode] is set to [Auto].

3.11.5 Module Mode

When the T1 is connected to a host monitor, it works as the host monitor’s parameter module. The T1 can be connected to the host monitor either through the internal or satellite module rack of the host monitor or through the T1 docking station.

When the T1 is connected to the host monitor through the internal or satellite module rack, the T1 screen is disabled.

When the T1 is detached from the host monitor, it returns to normal Monitoring mode. When the T1 is connected to the host monitor through the T1 docking station, some functions, including setting alarms, parameters, patient information, etc., can be achieved by operating either the host monitor or the T1. Refer to the host monitor’s operating manual for details.


Insert the T1 in the module rack of the host monitor

To use the T1 with the host monitor, insert the T1 into the host monitor’s internal module rack or satellite module rack.

Firmly push the T1 until you hear that the clip engages the module rack. To ensure that the T1 is properly connected, try to pull the T1 outward. The T1 is properly engaged in the module rack if you cannot pull the T1 out.

CAUTION



To prevent the T1 from falling out, after inserting the T1 into the module rack, always check that the T1 properly engages into the module rack.

To remove the T1 from the host monitor, lift the latch (refer to 2.2.1.4 Bottom View) at the bottom of the T1 and pull the

T1 out.

Connect the T1 with the host monitor through the docking station

To connect the T1 docking station to the host monitor:

1. Connect the T1 dock data cable (PN: 009-003591-00 or 009-003592-00) to the external device connector of the T1 docking station.

2. Connect the T1 dock data cable to the SMR connector of the host monitor.

To disconnect the T1 docking station from the host monitor:

1. Disconnect the T1 dock data cable from the host monitor.

2. Disconnect the T1 dock data cable from the T1 docking station.

WARNING





Do not unplug the T1 dock data cable during normal use. It may result in unknown problems.

Make sure that the T1 dock data cable is disconnected from the host monitor when the T1 docking station is not in use with the host monitor.


3.11.6 Standby Mode

In the Standby mode, you can temporarily stop patient monitoring without turning off the monitor.

To enter the Standby mode:


4

Managing Patients

4.1 Admitting a Patient

The monitor displays ans stores physiological data in trends as soon as a patient is connected. This allows you to monitor a patient that is not admitted yet. However, it is recommended that you fully admit a patient so that you can clearly identify them on reports and network devices.

To admit a patient:

If a patient has previously been admitted, a message [Are you sure to discharge the current patient and admit a

new patient?] pops up. Then select [Ok] to clear any previous patient data. If you do not erase data from the previous patient, the new patient’s data is combined with the previous patient’s data. The monitor makes no distinction between the old and the new patient data.

If no patient has been previously admitted, you can choose either:



[Yes] to apply the data saved in the monitor to the new patient, or



[No] to clear the data saved in the monitor.

3. In the [Patient Demographics] menu, enter the demographic details, of which:



[Patient Cat.] allows the user to select patient size (Neo, Ped, Adu) which will determine the way your monitor processes and calculates some measurements, and what safety and alarm limits are applied to your patient.



[Paced] determines whether to show pace pulse marks on the ECG waveform. When the [Paced] is set to [No], pace pulse marks are not shown in the ECG waveform.

WARNING



Make sure the [Patient Cat.] and [Paced] fields always contain a value, regardless of whether the patient is fully admitted or not.



For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak.



For non-paced patients, you must set [Paced] to [No].

For details about patient paced status, refer to section 8.3.4 Checking Paced Status.


4.2 Quick Admitting a Patient

Use [Quick Admit] only if you do not have the time or information to fully admit a patient. Complete the rest of the patient demographic details later.

To quick admit a patient: patient has previously been admitted, you can choose either:



[Yes] to apply the data in your monitor to the new patient, or



[No] to clear any previous patient data.

3. Enter the Patient Category and Paced Status for the new patient, and then select [Ok].

4.3 Querying and Obtaining Patient Information

The monitor can obtain patient information from the Hospital Information System (hereafter called HIS) through the eGateway. To query or obtain patient information from the HIS:

Setup >>]→[Gateway Comm Setup >>], and set [IP Address] and [Port]. Set [ADT Query] to [On]. Then select

[Ok].

2. Select the patient information area to enter the [Patient Demographics] menu.

4. Input a query condition and then select [Query]. The monitor displays the requested patient information.

5. Select a patient and then click [Import] to update the corresponding patient information.

6. Select to exit the [Obtain Patient Information] menu.

NOTE



The option [Obtain Patient Information] is available in the [Patient Setup] menu only when [ADT Query] is set to [On].



When obtaining patient information from the HIS, only patient information is updated onthe monitor. The patient’s physiological data is not changed and the patient is not discharged.

4.4 Associating Patient Information

After associating patient information with the HIS, the monitor automatically updates the the patient information if the corresponding HIS information changes. The monitor can associate the patient’s MRN(Medical Record Number), first name, last name, date of birth, and gender with the HIS.


NOTE



A keyword takes effect only when being defined in the eGateway. Refer to eGateway Integration Manager

Installation Guide (P/N: 046-002447-00) for details.



The monitor displays corresponding patient information only when all the keywords have been entered.

4.5 Editing Patient Information

To edit the patient information after a patient has been admitted, or when the patient information is incomplete:

4.6 Discharging a Patient

To discharge a patient:



Select [Ok] to discharge the current patient, or



Select [Standby] then [Ok]. The monitor enters the standby mode after discharging the current patient, or



Select [Cancel] to exit without discharging the patient.

NOTE



After discharging an admitted patient, you can review the history data of this patient by selecting [Main

Menu]→[Patient Setup >>]→[History Data>>] When the SD card is full, the oldest patient data will be

deleted automatically. Therefore, you cannot always view all the history data.

4.7 Transferring Patient Data

You can transfer patient data between monitors without re-entering the patient demographic information. Transferring of patient data enables you to review the patient’s history. The patient data that can be transferred includes: patient demographics, trend data, alarm events and parameters alarm limits.

You can use a USB drive to transfer data between two monitors. You can also connect the T1 with the host monitor to implement patient transfer. Refer to the operator manual of the host monitor.


WARNING





Do not discharge a patient before the patient is successfully transferred.

After a patient is successfully transferred, check if the patient settings (especially patient category, paced status and alarm limits settings, etc.) on the monitor are appropriate for this patient.

NOTE



The system automatically enables the HR alarm and lethal arrhythmia alarm after transferring the patient data.

4.7.1 Transferring Patient Data via a USB Drive

To transfer patient data to a USB drive:

2. In the pop-up menu, set [Data Transfer Method] to [USB Drive].

You can also set [Transferred Data Length]. The default is [4 h].

4.7.1.1 Transferring Data from the Monitor to a USB Drive

To transfer data from the monitor to a USB drive:


2. Connect a USB Drive to the T1 docking station’s USB connector.

5. Wait until the following message appears: [Transfer to storage medium successful. Please remove the USB

drive.].

6. Remove the USB drive from the T1 docking station.

4.7.1.2 Transferring Data from a USB Drive to the Monitor

To transfer data from a USB drive to the monitor:

1. Connect a USB Drive to the T1 docking station’s USB connector.

2. Select

→ [Others >>]

→ [Data Transfer Method] →[USB Drive]. Then:



Select [Transfer] to transfer the patient data to the monitor, or



Select [Cancel Transfer] to cancel the transfer operation, or



Select [Unload USB Drive] to keep the patient data and to unload the USB drive without transferring the patient data..


3. After you select [Transfer], in the pop-up menu you can select the patient data content that need to be transferred.

[Patient Demographics] must be selected. After selecting [Ok], the monitor compares the patient information stored in both the storage medium and monitor and manages the patient data based on the following:





Different Patients:

Same Patient:

The monitor erases all the current patient data, transfers the patient data from the storage medium, and loads the configuration according to the patient category.

In the pop-up dialog box, you can:

 Select [Yes] to merge the patient data in the monitor and storage medium.

 Select [No] to erase all the current patient data in the monitor and to transfer the patient data from the storage medium.

4. Wait until the message [Transfer from storage medium successful.] appears before removing the USB drive.

CAUTION









The USB drive you use may be write-protected. In this case, make sure the USB drive is in read/write mode.

Do not remove the storage medium during the data transfer process. Otherwise, data files may be damaged.

Check that the USB drive is removed before disconnecting the T1 from the T1 docking station.

The normal monitoring function will be affected during data export. Do not perform any monitoring activity during data export.

4.7.2 Transferring Patient Data via the T1 to a Host Monitor

The T1 can be used with a host monitor to implement patient transfer. For patient transfer via the host monitor, refer to the host monitor’s operating manual (PN: 046-005013-00) for detail.

4.8 Auto Deleting History Data from the SD Card

When the free space on the SD card is low, the monitor automatically deletes all patient history data, except the data of the currently monitored patient and the last patient monitored. If the free space on the SD card is still low after the auto deleting, the monitor will trigger a technical alarm to prompt: [Storage Card Space Low]. For details about the technical alarm, refer to section 0

Technical Alarm Messages.


4.9 Connecting to a CMS

The monitor supports connection to a CMS. If your monitor is connected to a CMS:

 All patient information, measurement data and settings on the monitor can be transferred to the CMS.

 All patient information, measurement data and settings can be displayed simultaneously on the monitor and CMS.

For some functions such as editing patient information, admitting a patient, discharging a patient, starting/stopping NIBP measurements, etc., bi-directional control can be achieved between the monitor and the

CMS.

NOTE



Only the DPM Central Station with system software version 01.01.00 or greater supports the T1.



Only the Panorama Central Station with system software version 11.5 or greater supports the T1.

For details, refer to the CMS’s instructions for use (PN: 0070-00-0728-52 for Panorama CMS and 046-005011-00 for DPM

CMS).


5

Managing Configurations

5.1 Introduction

When performing continuous patient monitoring, the clinical professional often needs to adjust the monitor’s settings according to the patient’s condition. The collection of all these settings is called a configuration. Allowing you to configure the monitor more efficiently, the monitor provides different sets of configurations to accommodate the varying patient categories and departments. You can change the settings from a default configuration and then save it as a user configuration.

The default configurations provided for your monitor are department-oriented. You can choose either from:



General



OR

 ICU

 NICU

 CCU

Each department has three different sets of configurations, one for each patient category, [Neo], [Ped], and [Adu]. For the configuration items and their default values and user maintenance items, see Appendix C Default Configurations.

NOTE



The configuration management function is password protected. The configuration management tasks must be performed by authorized personnel. Please contact your department manager or biomedical engineering department for the password used at your facility.


5.2 Accessing the [Manage Configuration] Menu

To access the [Manage Configuration] menu:

2. Enter the required password and then select [Ok].

5.3 Changing Department

If the current department configuration is not the one you want to view, you can select [Change Department >>] in the

[Manage Configuration] menu and then choose the desired department as shown below.

5-2

NOTE



Changing the department will delete all current user configurations.


5.4 Setting Default Configuration

The monitor will load the pre-set default configuration in the following cases:

 The monitor restarts after being switched off for more than 120 seconds.

 A patient is admitted.

 A patient is discharged.

 Patient data is cleared.

 Patient category is changed.

To set the default configuration:

2. In the [Select Default Config.] menu, select [Load the Latest Config.] or [Load Specified Config.].

When you select [Load Specified Config.], the restored configuration is subject to the patient category (adult, pediatric or neonate). This configuration can be either factory configuration or a saved user configuration. As an example, select

[Default Adu Config.] and toggle between [Defaults] or user configuration(s).

When you select [Load the Latest Config], the latest configuration is loaded when the monitor is started or a patient is admitted.

NOTE



To identify which configuration is restored when the monitor starts, enter the main screen to check the prompt information at the lower part of the screen.

5.5 Saving Current Settings

Current settings can be saved as a user configuration. Up to 3 user configurations can be saved.

To save current settings:

2. In the pop-up dialog box, enter the configuration name and then select [Ok]. The current settings are saved as a user configuration with the name you entered.


5.6 Editing Configurations

To edit an existing configuration: configurations on the monitor. Selecting [Config. on USB drive >>] will show the existing configurations on the

USB drive.

2. Select the desired configuration and then select the [Edit] button. settings can be changed. The changed alarm setup items will be marked in red.

4. You can select [Save] or [Save as] to save the changed configuration. Select [Save] to overwrite the original configuration. Select [Save as] to save the changed configuration as another file with another name.

5.7 Deleting a Configuration

To delete a configuration: configurations on the monitor. Select [Config. on USB drive >>] to show the existing user configurations on the

USB drive.

2. Select the user configurations you want to delete and then select [Delete].

5.8 Transferring a Configuration

When installing several monitors with identical user configurations, it is not necessary to set each unit separately. Use a

USB drive to transfer the configuration from monitor to monitor.

To export the current monitor’s configuration:

1. Connect a USB Drive to the USB connector on the T1 docking station.

3. In the [Export Config.] menu, select the configurations and [User Maintenance Settings] to export. Then select the [Export] button. A status message will report completion of the transfer.

To import the configuration from the USB drive to the monitor:

1. Connect the USB Drive to the USB connector on the T1 docking station.

3. In the [Import Config.] menu, select the configurations and [User Maintenance Settings] to import. Then select the [Import] button. A status message will report completion of the transfer.


5.9 Loading a Configuration

You may make changes to some settings during operation. However, these changes or the pre-selected configuration may not be appropriate for the newly admitted patient. Therefore, the monitor allows you to load a desired configuration to ensure that all the settings are appropriate for your patient.

To load a configuration: monitor.

2. Select a desired configuration.

NOTE



The monitor may configure some settings by default when you load a configuration of different software version with current configuration.

5.10 Restoring the Latest Configuration Automatically

During operation, you may make changes to some settings. However, these changes may not be saved as a user configuration. To prevent the changes from being lost in case of a sudden power failure, the monitor stores the configuration in real time. The saved configuration is the latest configuration.

The monitor restores the latest configuration if it restarts within 60 seconds after the power failure. And it will restore the default configuration rather than the latest configuration if it restarts 120 seconds after the power failure. The monitor loads either the latest configuration or the default configuration if it restarts from 60-120 seconds after the power failure.


FOR YOUR NOTES


6

User Screens

6.1 Adjusting the Screen Brightness

To adjust the screen brightness:

1. Select the [Main Menu]→[Screen Setup >>]→[Brightness].

2. Select the appropriate setting for the screen brightness.



1 to 10. 10 is the brightest, and 1 is the dimmest.



Auto: Screen brightness will be adjusted automatically.

If the monitor operates on battery power, setting a dimmer screen brightness will prolong the battery operating time.

When the monitor enters Standby mode, the screen automatically changes to the dimmest setting.

6.2 Adjusting Volume

Alarm Volume

To adjust the alarm volume: on the set minimum alarm volume (refer to section 7.4.1 Setting the Minimum Alarm Volume), and 10 is the maximum volume.

Key Volume

When you press the touchscreen, the monitor prompts you by making a sound of the key volume you have set.

To adjust the key volume:

QRS Volume

The QRS tone is derived from either the HR or PR, depending on which is currently selected as the alarm source in [ECG

Setup] or [SpO2 Setup]. When monitoring SpO

2

, there is a variable pitch tone which changes as the patient’s saturation level changes. The pitch of the tone rises as the saturation level increases and falls as the saturation level decreases. The tone volume is user adjustable.


To adjust the QRS volume:

1. Select the ECG parameter window →[Others >>], or the SpO

2

parameter window. volume.

6.3 Configuring Your Screens

You can configure your monitor’s screens by setting:

 Waveform line size

 The color in which each measurement’s numerics and waveforms are displayed

 The parameter to monitor

CAUTION



Changing some settings may be hazardous. Therefore, those settings are password-protected and can be modified by authorized personnel only. Once the change is made, notify those who use the monitor.

6.3.1 Changing the Waveform Line Size

To change the waveform line size:

6.3.2 Changing Measurement Colors

To change the measurement colors:

2. Select the color box next to your desired parameter, and then select a color from the pop-up menu.

6.3.3 Choosing a Screen

To choose a screen, select [Main Menu]→[Screens >>]→[Choose Screen]. You can choose either:

 Normal Screen

 Big Numerics screen

 ECG 7-Lead Full-Screen if 5-lead or 12-lead ECG is selected

 ECG 12-Lead Full-Screen if 12-lead ECG is selected


If the external display is connected, you can also choose:

 ECG 7-Lead Half-Screen if 5-lead or 12-lead ECG is selected

 Minitrends Screen

 OxyCRG Screen



View Others Screen



PAWP Screen

6.3.4 Changing the T1 Screen Layout

To change screen layout, select [Main Menu]→[Screens] to enter the [Screens] menu.

 You can choose the desired screen type in the [Choose Screen] window.

 You can select the parameters and waveforms you want to view in the [Screen Setup] window. For details, please refer to section 6.3 Configuring Your Screens.

 You can select the parameters you want to view on the big numerics screen in the [Big Numerics Screen Setup] window.

 You can switch the connected parameter modules on or off in the [Parameters Switch] window. If a parameter module is switched off, parameter values and waveforms will not display on the screen.

Area A

Area B

The ECG parameter and the first ECG waveform always display in the first row. The configurable areas can be classified as

Area A and Area B.

 In Area A, you can choose to display the parameters (having waveforms) and their waveforms. Each parameter and the associated waveform are displayed in the same row.

 In Area B, you can choose to display all the parameters except ECG. Associated waveforms will not be displayed.


WARNING



Unallocated parameters in the [Screen Setup] window do not display. However, the monitor can still sound alarms for these parameters.

6.3.5 Changing Screen Layout on the External Display

NOTE



The keys mentioned in this section refer to the keys on the external display.

To change the screen layout on the external display:

 Select the [Screens] QuickKey

and select [Screen Setup], or

 Select [Main Menu]→[Screen Setup >>]→[Screen Layout >>]→[Screen Setup].

6-4

Area C

Area A

Area B


The ECG parameter and the first ECG waveform always display in the first row. The configurable areas can be classified as

Area A, Area B, and Area C.

 In Area A, you can choose to display the parameters windows and their waveforms (if one exists). Each parameter and the associated waveform are displayed in the same row.

 In Area B, you can choose to display the parameter windows. But if all parameters in area C are set to [Off], both the parameter and waveform selected in the first row of area B will be displayed.

 In Area C, you can choose to display any parameters without associated waveforms.

6.4 Understanding the Big Numerics Screen

To enter the big numerics screen:

2. In the [Choose Screen] tab, select [Big Numerics].

To select the parameters displaying in this screen:

1. In the [Screens] menu select [Big Numerics Screen Setup].

2. Select the parameters you want. For parameters having a waveform, the waveform will not be displayed.

6.5 Viewing Minitrends (Only Available with the External Display)

NOTE





6.5.1 Having a Split-Screen View of Minitrends

You can split the normal screen so that the left hand side continuously shows graphic minitrends beside waveforms as shown in the figure below.

To have a split-screen view of minitrends, you can select [Main Menu]→[Screen Setup >>]→[Screen Layout >>]→

[Choose Screen]→[Minitrends Screen]→ .

Minitrend View

The split-screen view provides minitrends for multiple parameters. In each field, the label and scale are respectively displayed at the top and left. The time is displayed at the bottom of the minitrends view as shown below.


6.5.2 Setting Minitrends

Select the minitrends area. From the pop-up [Minitrend Setup] menu, you can:

 Select the parameters to be displayed, or

 Select [Minitrend Length] and then select the appropriate setting.

Time

6.6 Viewing OxyCRG (only available with the external display)

NOTE




To have a split screen view of OxyCRG, select [Main Menu]→[Screens]→[Choose Screen]→[OxyCRG Screen]→ .

1 2 3 4 5 6


The split-screen view covers the lower part of the waveform area and shows HR trend, SpO

2

trend, SpO

2 b trend, RR trend and a compressed waveform (CO

2

wave or Resp wave). At the bottom, there are controls:

1. Event

You can enter the [Review] menu by selecting the [Event] button.

2. Trend length list box

In the trend length list box, you can select [1 min], [2 min], [4 min], or [8 min].

3. Setup

Select the [Setup] button to enter the [Setup] menu, in which you can select the parameters for display, the time length to be saved before and after an event, and the scale of the graphic trends and waveform. The trend area can display two parameter trends, e.g. HR trend and RR trend, simultaneously.

Select the [Auto Scale] button, and the system automatically adjusts the scaling.

5. Print

6. Record

6.7 Viewing Other Patients (Only Available with the External Display)

NOTE




6.7.1 Care Group

You can select up to 10 monitors (including telemetry) connected to the same CMS or LAN into a care group. This lets you:

 View information on the monitor screen from another bed in the same care group.

 Be notified of physiological and technical alarm conditions at the other beds in the same care group.

To have a care group:

1. Open the [View Other Patient] window by:



Selecting [Others] QuickKey, or



Selecting the [Screens] QuickKey

→[Choose Screen]→[View Others Screen], or



Selecting [Main Menu]→[Screen Setup >>]→[Screen Layout >>]→[Choose Screen]→[View Others Screen]

3. Select the desired monitors from the [Connected Monitor List]. The selected monitors constitute a care group.


NOTES



Monitors using software version prior to 05.17.00 cannot view or be viewed by monitors of software version

05.17.00 or later.



Re-set the Care Group if the monitor is moved to a department or different LAN.

6.7.2 Viewing the Care Group Overview Bar

The Care Group Overview bar is located at the bottom of the [View Other Patient] window. In the overview bar, the department and bed label for any care group beds are displayed. For telemetry, # is displayed before the department label. The color in which a care group bed appears matches its status:

 Red: indicates the bed is having high-level physiological alarms or the telemetry is in alarm, such as nurse call or event.

 Yellow: indicates the bed is having medium-level or low-level physiological alarms, or medium-level technical alarms.

 Blue: indicates the bed is having low-level technical alarms.

 Light grey: indicates the bed fails to be networked.

 Dark grey: indicates the bed is in the Standby mode.

You can view a care group bed’s alarms by selecting it from the care group, and you can select the [View This Patient] button to view the bed in the [View Other Patient] window.

For more details about care group alarms, refer to chapter 7 Alarms.

6.7.3 Understanding the View Other Patient Window

When you first open the [View Other Patient] window, the monitor automatically selects a device from the network to display in the [View Other Patient] window.

4

1

5

2

3


6-10

The [View Other Patient] window covers the lower part of the waveform area and consists of:

1. Information Area: shows the patient information (including department, bed number, patient name, etc.), and network status symbol.

2. View Area: shows physiological waveforms and parameters. You can switch a waveform area to a parameter area by selecting your desired waveform area and then selecting [Switch to Parameter Area], or switch a parameter area to a waveform area by selecting your desired parameter area and then selecting [Switch to Waveform Area].

3. Care Group Overview Bar. For details, refer to section 6.7.2 Viewing the Care Group Overview Bar.

4. Message Area: shows physiological, technical and prompt messages from the currently viewed monitor. It also shows the alarm given by the device such as nurse call or event. By selecting this area, you can enter the [Alarm

Information List] to view all physiological, technical and prompt messages coming from the currently viewed patient.

5. [Alarm Reset] button: resets alarms from the currently viewed bed. Refer to section 7.11.3 Resetting Care Group

Alarms.

When the [Reset Other Bed’s Alarms] is disabled, there is no button appearing here.

Additionally, you can change a waveform or parameter for viewing:

 To change a waveform for viewing, select the waveform segment where you want a new waveform to appear and then select the waveform you want from the pop-up menu.

 To change a parameter for viewing, select the parameter window where you want a new parameter to appear and then select the parameter you want from the pop-up menu.

WARNING



The data presented in the [View Other Patient] window has a delay. Do not rely on this window for real time data.



The icon indicates disconnection to the viewed monitor. You cannot view the monitor when this icon is displayed.


7

Alarms

Alarms, triggered by an abnormal vital sign or technical issue with the monitor as visually and audibly indicated to the user.

WARNING



A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room.



If your monitor is connected to a CMS, alarms can be controlled remotely. Remote suspension, inhibition, and reset of monitor alarms via the CMS may cause a potential hazard. For details, refer to the CMS’s operator’s manual.

For troubleshooting specific alarms, see appendix D Alarm Messages.

7.1 Alarm Categories

The monitor’s alarms are classified into two categories: physiological alarms and technical alarms.

Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition. Physiological alarm messages are displayed in the physiological alarm area. Refer to section 2.4 Display Screen for details.

Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion due to improper operation or mechanical problems. Technical alarm messages are displayed in the technical alarm area. Refer to section 2.4 Display Screen for details.

Apart from the physiological and technical alarm messages, the monitor will show some messages telling the system status or patient status. Messages of this kind are included in the prompt message category and usually displayed in the prompt information area. Some prompt messages that indicate the arrhythmia events are displayed in the physiological alarm area. For some measurements, their related prompt messages are displayed in their respective parameter windows.


7.2 Alarm Levels

The monitor’s alarms can be classified into three seerity categories: high level, medium level and low level.

Physiological alarms

High level

Indicatess that the patient is in a life threatening situation, such as Asystole,

Technical alarms

Indicates a severe device malfunction or an improper operation which could make it possible that the monitor cannot detect critical patient status and thus threaten the patient’s life.

Medium level

Low level

Vfib/Vtac and so forth, and emergency treatment is required.

Indicates that the patient’s vital signs appear abnormal and immediate treatment is required.

Indicates that the patient’s vital signs appear abnormal and immediate treatment may be required.

Indicates a device malfunction or an improper operation, which may not threaten the patient’s life but may compromise the monitoring of vital physiological parameters.

Indicates a device malfunction or an improper operation, which may compromise a certain monitoring function but will not threaten the patient’s life.

7.3 Alarm Indicators

When an alarm occurs, the monitor will prompt the user through visual or audible alarm indicators.

 Alarm lamp

 Audible alarm tones

 Alarm message

 Flashing numerics

7.3.1 Alarm Lamp

If a technical alarm or physiological alarm occurs, the alarm lamp may flash. The color and flashing frequency correspond to the alarm level as follows:

 High level alarms: the lamp quickly flashes red

 Medium level alarms: the lamp slowly flashes yellow

 Low level alarms: the lamp lights yellow without flashing

7.3.2 Alarm Messages

When an alarm occurs, an alarm message will appear in the technical or physiological alarm area. For physiological alarms, the asterisks (*) before the alarm message match the alarm level as follows:

 High level alarms:

***

 Medium level alarms: **

 Low level alarms:

*


You can view the alarm messages by selecting the physiological or technical alarm area. Refer to 2.4 Display Screen for details.

7.3.3 Flashing Numeric

If an alarm triggered by an alarm limit violation occurs, the numeric portion of the measurement in alarm will flash every second, and the corresponding alarm limit will also flash at the same frequency indicating the high or low alarm limit is violated.

7.3.4 Audible Alarm Tones

The alarm tone is distinct from the heart beat tone, keystroke tone and pulse tone in frequency. This monitor has three alarm tones and patterns: ISO, Mode 1 and Mode 2. For each pattern, the alarm tones identify the alarm levels as follows:

 ISO pattern:



High level alarms: triple+double+triple+double beep



Medium level alarms: triple beep



Low level alarms:

 Mode 1:



High level alarms: single beep high-pitched single beep



Medium level alarms: double beep



Low level alarms:

 Mode 2: low-pitched single beep



High level alarms: high-pitched triple beep



Medium level alarms: double beep



Low level alarms: low-pitched single beep

Additionally, the alarm message has a different background color which corresponds to the alarm level:

 High level alarms: red

 Medium level alarms: yellow

 Low level alarms: yellow

NOTE



When multiple alarms of different levels occur simultaneously, the monitor will select the highest level alarm, light the alarm lamp and give alarm sounds accordingly, while all the alarm messages scroll on the screen.



Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and alarm lights with normal high level physiological alarms, but their alarm messages are displayed exclusively. That is, when an exclusive physiological alarm and a normal high level physiological alarm are triggered simultaneously, only exclusive physiological alarm message will be displayed.


7.3.5 Alarm Status Symbols

Apart from the aforementioned alarm indicators, the monitor still uses the following symbols telling the alarm status:



indicates alarms are paused.





indicates alarm is reset.

indicates the alarm sound is turned off.



indicates individual measurement alarms are turned off or the system is in alarm off status.

7.4 Alarm Tone Configuration

7.4.1 Setting the Minimum Alarm Volume

To set the minimum alarm volume:

The minimum alarm volume refers to the minimum value you can set for the alarm volume, which is not affected by user or factory default configurations. The minimum alarm volume setting remains unchanged when the monitor shuts down and restarts.

7.4.2 Changing the Alarm Volume

To change the alarm volume:

2. Select the appropriate volume from [Alm Volume]: X to 10, in which X is the minimum volume, depending on the set minimum alarm volume, and 10 is the maximum volume.

[Alm Volume+2].

When the alarm volume is set to 0, the alarm sound is turned off and a symbol appears on the alarm symbols area of the screen.


7.4.3 Setting the Interval between Alarm Sounds

If you choose the ISO pattern, you can change the interval between alarm tones. To change the interval between alarm tones: the appropriate settings.

You cannot change the interval between alarm tones if you choose mode 1 or 2 as your desired alarm tone pattern. For these two patterns, the interval between alarm tones identifies the alarm levels as follows:

 Mode 1:



Interval between high level alarm tones: continuously



Interval between medium level alarm tones: 5 s



Interval between low level alarm tones: 20 s

 Mode 2:



Interval between high level alarm tones: 1 s



Interval between medium level alarm tones: 5 s



Interval between low level alarm tones: 20 s

WARNING



When the alarm sound is switched off, the monitor does not provide any audible alarm tones even if a new alarm occurs. Therefore the user should be very careful about switching off the alarm sound.



Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance.

7.4.4 Changing the Alarm Tone Pattern

To change the alarm tone pattern:

NOTE



User or factory default configurations have no impact on the setup of alarm tone pattern. The alarm tone pattern remains unchanged after the monitor restarts.


7.4.5 Setting the Reminder Tones

When the alarm volume is set to zero, or the alarm tone is silenced or turned off, the monitor issues a periodic reminder tone.

To set the reminder tones:



To switch the reminder tones on or off, select [Reminder Tones] and then select [On] or [Off].



To set the interval between reminder tones, select [Reminder Interval] and then select [1min], [2min] or

[3min].

In addition, you can set the volume of alarm reminder tones. To set the alarm reminder tone volume, select [Main Menu]

→[Alarm Setup >>]→[Others]. Then, select [Reminder Vol] and then select [High], [Med] or [Low].

7.5 Understanding the Alarm Setup Menu

Select [Main Menu]→[Alarm Setup >>] to enter the [Alarm Setup] menu, where you can:

 Set alarm properties for all parameters.



Change ST alarm settings.



Change arrhythmia alarm settings.



Set the threshold for some arrhythmia alarms.

 Change other settings.

When a DPM CMS is used, the [Alarm Setup] menu displays as below:


When a Panorama CMS is used, the [Alarm Setup] menu displays as below:

NOTE



The On/Off column is only not visible with Panorama CMS.

Refer to chapter 8 Monitoring ECG for how to change ST alarm settings, how to change arrhythmia alarm settings, and how to set the threshold for some arrhythmia alarms.

7.5.1 Setting Alarm Properties for All Parameters

In the [Main Menu], select [Alarm Setup >>]→[Parameters]. You can review and set alarm limits, alarm switches, and alarm level for all parameters.

WARNING





Make sure that the alarm limits settings are appropriate for your patient before monitoring.

Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration, do NOT set the high alarm limit to 100%, which is equivalent to switching the alarm off.



When monitoring patients that are not continuously attended by a clinical operator, properly configure the alarm system and adjust alarm settings as per the patient's condition.

7.5.2 Adjusting Alarm Limits Automatically

The monitor can automatically adjust alarm limits according to the measured vital signs. When auto limits are selected, the monitor calculates safe auto limits based on the latest measured values.


To get accurate auto alarm limits, you need to collect a set of measured vital signs as a baseline. Then, in the [Main

Menu], select [Alarm Setup >>]→[Parameters]→[Auto Limits] →[Ok]. The monitor will create new alarm limits based on the measured values.

Before applying these automatically created alarm limits, confirm if they are appropriate for your patient in the [Alarm

Setup Menu]. If not, you can adjust them manually. These alarm limits will remain unchanged until you select auto limits again or adjust them manually.

The monitor calculates the auto limits based on the following rules.

Low alarm limit

Module Parameter

Adult/ pediatric

Neonate

High alarm limit


(HR × 0.8) or 40 bpm

ECG HR/PR

(whichever is greater)

(HR – 30) or 90 bpm (whichever

240 bpm

(whichever is is greater)

(HR × 1.25) or smaller)

Neonate

Auto alarm limits range

(HR + 40) or 200 bpm (whichever

Adult/pediatric: 35 to 240

Neonate: 55 to 225 is smaller)

Resp RR

SpO

2

NIBP

SpO

2

NIBP-S

NIBP-D

(RR × 0.5) or 6 is greater)

(RR – 10) or 30 rpm (whichever rpm (whichever is greater)

(RR × 1.5) or 30 rpm (whichever rpm (whichever

Adult/pediatric: 6 to 55

Neonate: 10 to 90 is smaller)

(RR + 25) or 85 is smaller)

Same as the Same as the Same as the Same as the default alarm limit default alarm limit default alarm limit default alarm limit

Same as the measurement range

(SYS × 0.68 +

10) mmHg

(SYS – 15) or 45 mmHg


(SYS + 15) or 105

Adult: 45 to 270

(SYS × 0.86 + 38) mmHg

Pediatric: 45 to 185 mmHg (whichever is

Neonate: 40 to 115 smaller)

(Dia – 15) or 20

(Dia × 0.68 + 6) mmHg mmHg (whichever is greater)

(Dia + 15) or 80

Adult: 25 to 210

(Dia × 0.86 + 32) mmHg



Temp

IBP: ART/

Ao/

UAP/

BAP/

NIBP-M

T1

T2

TD

IBP-S

(Mean – 15) or 35

(Mean × 0.68 + mmHg

(Mean + 15 or

(Mean × 0.86 + 95) mmHg

8) mmHg (whichever is greater)

35) mmHg (whichever is smaller)

(T1 – 0.5) °C

(T2 – 0.5) °C

Same as the default alarm limit

(SYS × 0.68＋

10) mmHg

(T1 – 0.5) °C

(T2 – 0.5) °C


(T1 + 0.5) °C

(T2 + 0.5) °C


(T1 + 0.5) °C

(T2 + 0.5) °C


Adult: 30 to 230

Pediatric: 30 to 165

Neonate: 25 to 105

1 to 49 °C

1 to 49 °C


(SYS – 15) or 45 mmHg


(SYS + 15) or 105

Adult: 45 to 270

(SYS × 0.86＋38) mmHg




Low alarm limit

Module Parameter


Neonate

FAP/ (Dia – 15) or 20

LV/

P1-P4

(Arterial

IBP-D

(Dia × 0.68＋6) mmHg mmHg (whichever is greater) pressure)

IBP-M

High alarm limit


(Dia × 0.86＋32) mmHg

Neonate

(Diav15) or 80 mmHg

(whichever is smaller)

(Mean × 0.68 + 35 mmHg

8) mmHg

(Mean – 15) or

(whichever is 35) mmHg

(Mean + 15) or

(Mean × 0.86 + 95 mmHg

(whichever is greater) smaller)

Auto alarm limits range

Adult: 25 to 225


Neonate: 20 to 90

Adult: 30 to 245


Neonate: 25 to 105

SYS × 0.75 SYS × 0.75

Dia × 0.75 Dia × 0.75

Mean × 0.75 Mean × 0.75

SYS × 1.25

Dia × 1.25

Mean × 1.25

SYS × 1.25

Dia × 1.25

Mean × 1.25

3 to 120 mmHg PA

IBP-S

IBP-D

IBP-M

IBP:

CVP/

ICP/

LAP/

RAP/

UVP/

P1-P4

(Venous pressure)

IBP-M Mean × 0.75 Mean × 0.75 Mean × 1.25 Mean × 1.25 3 to 40 mmHg

CO

2

Et CO

2

0 to 32 mmHg: 0 to 32 mmHg: remains the remains the same same

0 to 32 mmHg: remains the same

0 to 32 mmHg: remains the same

32 to 35 mmHg: 32 to 35 mmHg: 32 to 35 mmHg: 32 to 35 mmHg:

29 mmHg 29 mmHg 41 mmHg 41 mmHg

35 to 45 mmHg:

35 to 45 mmHg:

(etCO

2

-6)

(etCO

2

-6) mmHg mmHg

35 to 45 mmHg:

(etCO

2

+6) mmHg

35 to 45 mmHg:

(etCO

2

+6) mmHg


45 to 48 mmHg: 45 to 48 mmHg: 45 to 48 mmHg: 45 to 48 mmHg:

39 mmHg 39 mmHg 51 mmHg 51 mmHg

>48 mmHg: remains the same

>48mmHg: remains the same



FiCO2 N/A awRR

N/A



Same as the measurement range awRR × 0.5 or 6 (awRR – 10) or 30 awRR × 1.5 or 30 (awRR+25) or 85

Adult/pediatric: 6 to 55 rpm (whichever rpm (whichever rpm (whichever rpm (whichever

Neonate: 10 to 90 is greater) is greater) is smaller) is smaller)


7.5.3 Setting Alarm Delay Time

You can set the alarm delay time for alarms of continuously measured parameters. If the alarm condition is resolved within the delay time, the monitor will not sound the alarm.

To set the alarm delay time:

[Ok].

Alarm delay is not applied to the following physiological alarms:

 Apnea

 ST alarms

 Arrhythmia alarms

 ECG weak signal

 Resp artifact

 SpO

2

Desat

 No pulse

 Nellcor SpO

2

over alarm limits

 HR over alarm limits

 Measurements of noncontinuous parameters over alarm limits

You can set [Apnea Delay] and [ST Alarm Delay] separately.

To set the [Apnea Delay], select [Main Menu]→[Alarm Setup >>]→[Others].

To set the [ST Alarm Delay]:

[Ok].

7.5.4 Setting SpO

2

Technical Alarm Delay

You can set the [Tech. Alarm Delay] in the [Others] tab of the [Alarm Setup] menu. The options are [Off], [5 s], [10 s] and [15 s]. The delay is effective to the following technical alarms: SpO

2

Sensor Off, SpO

2

Too Much Light, SpO

2

Low

Signal and SpO

2

Interference.


7.5.5 Setting Recording Length

You can change the length of the recorded waveforms. In the [Others] window of the [Alarm Setup] menu, select

[Recording Length] and then select [8 s], [16 s] or [32 s]:

 [8 s]: 4 seconds respectively before and after the alarm or manual event trigger moment.



7.5.6 Entering CPB Mode (Cardiopulmonary Bypass Mode)

When performing CPB, you can put the monitor in CPB mode in order to reduce unnecessary alarms. The CPB mode is activated only if you set the department to [OR]. To set the deparment to [OR]: select [Ok].

In the CPB mode, all the physiological alarms are switched off. In CPB mode, [CPB Mode] is displayed in the physiological alarm area with a red background color.

To enter CPB mode:

2. Then select [Ok] in the pop-up dialog box.

7.6 Pausing Alarms

You can temporarily disable alarm indicators by pressing the on-screen [Alarm Pause] QuickKey . When alarms are paused:

 For physiological alarms, no alarm indication is shown. New physiological alarms will not be presented.

 The remaining alarm pause time is displayed in the physiological alarm area.

 For technical alarms, alarm sounds are paused, but alarm lamps and alarm messages remain presented.

 The

alarms pause symbol is displayed in the sound symbol area. If a new technical alarm is triggered in the alarm paused period, the alarm message will be displayed.

When the alarm pause time expires, the alarm paused status is automatically deactivated. You can also cancel the alarm paused status by pressing the QuickKey.

The alarm pause time can be set to [1 min], [2 min], [3 min], [5 min], [10 min], [15 min] or [Permanent]. The default alarm pause time is 2 minutes.


7.7 Switching Off All Alarms

If [Alarm Pause Time] is set to [Permanent]: the monitor will enter into the alarm off status after the QuickKey is pressed. During the alarm off status:

 As for physiological alarms: no alarm lamps flash and no alarms are sounded.

 As for physiological alarms: no numerics or alarm limits flash.

 No physiological alarm messages are shown.

 [Alarm Off] is displayed in the physiological alarm area with red background.

 As for technical alarms: no alarms are sounded.

 The alarm off symbol

is displayed in the alarm symbol area.

You can cancel the alarm off status by pressing the QuickKey.

WARNING



Pausing or switching off alarms may result in a hazard to the patient.

7.8 Resetting Alarms

By selecting the QuickKey, you can reset the alarm system to acknowledge the on-going alarms and enable the alarm system to respond to a subsequent alarm condition.

For physiological alarms, except the NIBP-related alarms, when the alarm system is reset:

 The alarm sound is silenced.



A √ appears before the alarm message, indicating that the alarm is acknowledged.

 The icon

appears in the alarm symbol area.

 The parameter numeric and alarm limits still flash.

The indication of alarm lamp for the physiological alarm depends on the alarm light setting.

 When [Alarm Light on Alarm Reset] is set to [On], the alarm lamp remains flashing.

 When [Alarm Light on Alarm Reset] is set to [Off], the alarm lamp stops flashing.

To set [Alarm Light on Alarm Reset]:

The default setting for [Alarm Light on Alarm Reset] is [On].


Technical alarms give different alarm indicators when the alarm system is reset:

 For some technical alarms, including the NIBP-related alarms, a √ appears before the alarm message and appears in the alarm symbol area, indicating that the alarm is acknowledged. The indication of the alarm lamp depends on the alarm light setting.

 Some technical alarms are changed to the prompt messages.

 Some technical alarms are cleared. The monitor gives no alarm indications.

For details about the indications of technical alarms when the alarm system is reset, refer to appendix 0

Technical Alarm Messages.

7.9 Latching Alarms

The alarm latching setting for your monitor defines how the alarm indicators behave when you do not acknowledge them.

 If an alarm is latched, alarm indications remain presented even though alarm conditions end, except that:



The parameter reading and violated alarm limit stop flashing.



The time when the alarm was last triggered is displayed behind the alarm message.

 If an alarm is not latched, the alarm indications disappear as soon as the alarm conditions end.

When the alarm system is reset, the latched physiological alarms are cleared.

To latch a physiological alarm:



If you select [High only]: only high priority alarms are latched;



If you select [Hi&Med]: both high priority alarms and medium priority alarms are latched;



If you select [All]: all alarms are latched;



If you select [Off]: the alarm latching is turned off.

NOTE



Changing of alarm priority may affect the latching status of corresponding alarms. Determine if you need to reset the latching status for the specific alarm after changing its alarm priority.



When the alarm system is reset, the latched physiological alarms are cleared.


7.10 Testing Alarms

When the monitor starts up, a self-test is performed. In this case the alarm lamp is lit in yellow and red respectively, and the system gives a beep. This indicates that the visible and audible alarm indicators are functioning correctly.

For further testing of individual measurement alarms: perform the measurement on yourself (for example, SpO

2

or CO

2

) or use a simulator. Then, adjust alarm limits and check that appropriate alarm behaviour is observed.

7.11 Using Care Group Alarms (Only Available with the External Display)

NOTE




7.11.1 Care Group Auto Alarms

When a Care Group is set up on your monitor, a flashing symbol will appear beside the QuickKeys area if any monitor in your Care Group, which is not currently viewed by your monitor, is alarming. The alarm symbol is shown as below.

When a monitor in the Care Group is disconnected, the flashing symbol is shown as below.

The department and bed label of the alarming monitor appear on the symbols. You can enter the View Other Patient window by pressing this symbol.

7.11.2 Setting Care Group Alert Tone

When a monitor in the Care Group issue an alarm, your monitor prompts you by sounding an alert tone.

To set the alert tone:

1. In the [Main Menu], select [Screen Setup >>]→[Screen Layout >>]→[Choose Screen].

2. In the [Choose Screen] window, select [View Others Screen].

3. In the View Other Patient window, select [Setup>>], and set [Alert Tone] to [Repeat], [Once] or [Off].


7.11.3 Resetting Care Group Alarms

You can reset the alarm of the currently viewed bed in the View Other Patient window. To enable this function:

Setup>>].

2. In the [Alarm Setup] menu, set [Reset Other Bed’s Alarms] to [On].

When your monitor is viewed by other monitors and [Alarm Reset By Other Bed] is switched on, alarms on your monitor can be reset by other monitors.

WARNING



Resetting care group alarms may cause a potential hazard.


FOR YOUR NOTES


8

Monitoring ECG


The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric. ECG monitoring provides the following algorithms:



Advanced ECG algorithm

The Advanced ECG algorithm provides 3-, 5- and 12-lead ECG monitoring, ST-segment analysis, and extended arrhythmia analysis.

 Mortara ECG algorithm

The Mortara ECG algorithm provides 3-, 5- and 12-lead ECG monitoring, ST-segment analysis, and arrhythmia analysis.



Glasgow algorithm

Glasgow algorithm provides an interpretation of the resting 12-lead ECG.

You can select algorithms at the time of purchase or as upgrades post sale:

 The equipment incorporating the Advanced ECG algorithm is labeled with a ST/ARR label.

 The equipment incorporating the Mortara ECG algorithm is labeled with the Mortara logo.

 The equipment incorporating the Glasgow algorithm is labeled with the Glasgow logo.

8.2 Safety

WARNING







This equipment is not intended for direct cardiac application.

Use only ECG electrodes and cables specified by Mindray.

Make sure the conductive parts of electrodes and associated connectors for applied parts, including the neutral electrode, should not contact any other conductive parts including earth.



Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace the electrodes or change the application site.







Use defibrillation-proof ECG cables during defibrillation.

Do not touch the patient or metal devices connected to the patient during defibrillation.

To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitor’s cables and transducers never come into contact with the electrosurgery unit (ESU).



The neutral electrode of the HF surgical unit shall properly contact the patient. Otherwise, burns may result.


CAUTION



Interference from a non-grounded instrument near the patient and electrosurgery interference can cause problems with the waveform.

NOTE



After defibrillation, the screen display recovers within 10 seconds if the correct electrodes are used and applied in accordance with the instructions for use.

8.3 Preparing to Monitor ECG

8.3.1 Preparing the Patient and Placing the Electrodes

To prepare the patient and place the electrodes:

1. Prepare the patient’s skin. Proper skin preparation is necessary for good signal quality at the electrode site, as the skin is a poor conductor of electricity. To properly prepare the skin, choose flat areas and then follow this procedure:



Shave hair from skin at chosen sites.



Gently rub skin surface at sites to remove dead skin cells.



Thoroughly cleanse the site with a mild soap and water solution. We do not recommend using ether or pure alcohol, because this dries the skin and increases the resistance.



Dry the skin completely before applying the electrodes.

2. Attach the clips or snaps to the electrodes before placing them.

3. Place the electrodes on the patient.

4. Attach the electrode cable to the patient cable and then plug the patient cable into the ECG connector.

8.3.2 Choosing AHA or IEC Lead Placement

To choose AHA or IEC lead placement:

1. Select the ECG parameter window or waveform area to enter the [ECG Setup] menu. electrodes.


8.3.3 ECG Lead Placements

The electrode placement illustrations in this chapter adopt the AHA standard.

3-Leadwire Electrode Placement

Following is an electrode configuration when using 3 leadwires:

 RA placement: directly below the clavicle and near the right shoulder.

 LA placement: directly below the clavicle and near the left shoulder.

 LL placement: on the left lower abdomen.


Following is an electrode configuration when using 5 leadwires:

 RA placement: directly below the clavicle and near the right shoulder.

 LA placement: directly below the clavicle and near the left shoulder.

 RL placement: on the right lower abdomen.

 LL placement: on the left lower abdomen.

 V placement: on the chest.

The chest (V) electrode can be placed on one of the following positions:

 V1 placement: on the fourth intercostal space at the right sternal border.

 V2 placement: on the fourth intercostal space at the left sternal border.

 V3 placement: midway between the V2 and V4 electrode positions.

 V4 placement: on the fifth intercostal space at the left midclavicular line.

 V5 placement: on the left anterior axillary line, horizontal with the V4 electrode position.

 V6 placement: on the left midaxillary line, horizontal with the V4 electrode position.

 V3R-V6R placement: on the right side of the chest in positions corresponding to those on the left.

 VE placement: over the xiphoid process.



V7 placement: on posterior chest at the left posterior axillary line in the fifth intercostal space.

 V7R placement: on posterior chest at the right posterior axillary line in the fifth intercostal space.



12-lead ECG uses 10 electrodes, which are placed on the patient’s four limbs and chest. The limb electrodes should be placed on the soft skin and the chest electrodes placed according to the physician’s preference.

Lead Placement for Surgical Patients

The surgical site should be taken into consideration when placing electrodes on a surgical patient. e.g. for open-chest surgery, the chest electrodes can be placed on the lateral chest or back. To reduce artifacts and interference from electrosurgical units, you can place the limb electrodes close to the shoulders and lower abdomen and the chest electrodes on the left side of the mid-chest.

Do not place the electrodes on the upper arm. Otherwise, the ECG waveform will be very small.

WARNING



When using electrosurgical units (ESU), patient leads should be placed in a position that is equal distance from the electrosurgery electrotome and the grounding plate to avoid burns to the patient. Never entangle the ESU cable and the ECG cable together.



When using electrosurgical units (ESU), never place ECG electrodes near to the grounding plate of the ESU, as this can cause a lot of interference on the ECG signal.

8.3.4 Checking Paced Status

It is important to set the paced status correctly when you start monitoring ECG. The paced symbol is displayed when the [Paced] is set to [Yes]. The pace pulse markers “|” are shown on the ECG wave when the patient has a paced signal. If [Paced] is set to [No] or the patient’s paced status is not selected, the symbol will be shown in the patient information area.

To change the paced status, you can select either:



the patient information area, or

 [Main Menu]→[Patient Setup]→[Patient Demographics], or,

 the ECG parameter window or waveform area→[Others >>], and then, select [Paced] from the pop-up menu and then select [Yes] or [No].

If you do not set the paced status, the monitor issues a prompt tone when pace pulse is detected. At the same time, the paced symbol flashes and the message [Please confirm the pace of patient] appears in the ECG waveform area. Then, please check and set the paced status of the patient.


WARNING











For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak.

On ventricular paced patients, episodes of Ventricular Tachycardia may not always be detected.

False low heart rate indicators or false Asystole calls may result with certain pacemakers because of pacemaker artifact such as electrical overshoot of the pacemaker overlapping the true QRS complexes.



Do not rely entirely upon the system’s automated arrhythmia detection algorithm. Keep pacemaker patients under close surveillance.

For non-paced patients, you must set [Paced] to [No].

The auto pacer recognition function is not applicable to pediatric and neonatal patients.

8.4 Understanding the ECG Display

Your display may be configured to look slightly different.

1 2 3 4

1. Lead label of the displayed wave

3. ECG filter label

4. Notch filter status

Additionally, when a paced signal has been detected, the pace pulse marks “|” are shown on the ECG wave if the [Paced] setting has been configured to [Yes].

2

3

1

1. Current heart rate alarm limits

2. Heart beat symbol

3. Current heart rate

For 12-lead ECG display screen, refer to section 8.10 12-Lead ECG Monitoring.


8.5 Changing ECG Settings

8.5.1 Accessing ECG Menus

By selecting the ECG parameter window or waveform area, you can access the [ECG Setup] menu.

8.5.2 Setting Pacemaker Rate (For Mortara ECG Algorithm only)

Some pacemaker pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex and could result in an incorrect HR and failure to detect some arrhythmias. You can set [Pacemaker Rate] to the pacemaker’s rate in the [ECG Setup] menu. In this way, the monitor can calculate HR and detect arrhythmias more accurately. When

[Paced] is set to [No], the pacemaker rate cannot be set.

8.5.3 Choosing the Alarm Source

In most cases the HR and PR numerics are identical. In order to avoid simultaneous alarms on HR and PR, the monitor uses either HR or PR as its active alarm source. To change the alarm source, select [Alm Source] in the [ECG Setup] menu and then select either:

 [HR]: if you want the HR to be the alarm source for HR/PR.

 [PR]: if you want the PR to be the alarm source for HR/PR.

 [Auto]: If the [Alm Source] is set to [Auto], the monitor will use the heart rate from the ECG measurements as the alarm source whenever a valid heart rate is available. If the heart rate becomes unavailable, for example the ECG module is turned off or becomes disconnected, the monitor will automatically switch to PR as the alarm source.

8.5.4 Changing ECG Wave Settings

In the [ECG Setup] menu:

 You can select [ECG], [ECG1], or [ECG2] to select a lead to view. The ECG lead (s) selected is used for analysis (beat detection, beat classification, and V-Fib detection). The waveform of selected lead should have the following characteristics:



The QRS should be either completely above or below the baseline and it should not be biphasic.



The QRS should be tall and narrow.



The P-waves and T-waves should be less than 0.2mV.

 If the wave is too small or clipped, you can change its size by selecting an appropriate [Gain] setting. If you select

[Auto] from [Gain], the monitor will automatically adjust the size of the ECG waves. In normal screen, only the selected ECG wave can be adjusted. In other screens, all ECG waves can be adjusted simultaneously.

 You can change the wave sweep speed by selecting [Sweep] and then selecting the appropriate setting.

NOTE



Changing the display gain on the monitor does not affect the amplitude of signal that is used by the algorithm for beat detection.


8.5.5 Changing the ECG Filter Settings

The ECG filter setting defines how ECG waves are smoothed. To change the filter setting, select [Filter] from [ECG Setup] and then select the appropriate setting.

 [Mon]: Use under normal measurement conditions.

 [Diag]: Use when diagnostic quality is required. The unfiltered ECG wave is displayed so that changes such as

R-wave notching or discrete elevation or depression of the ST segment are visible.

 [Surg]: Use when the signal is distorted by high frequency or low frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular. Low frequency interference usually leads to wandering or rough baseline. In the operating room, the surgery filter reduces artifacts and interference from electrosurgical units. Under normal measurement conditions, selecting [Surgery] may suppress the QRS complexes too much and then interfere with ECG analysis.

 [ST]: Use when ST monitoring is applied.

CAUTION



The [Diagnostic] filter is recommended when monitoring a patient in an environment with slight interference only.

8.5.6 Setting the ECG Lead Set

You can set the [Lead Set] by selecting [ECG Setup]

→[Others >>]. You can set the [Lead Set] as [Auto] if the auto lead detection function is available.

8.5.7 Choosing an ECG Display Screen

When monitoring with a 5-lead or 12-lead set, you can select [Main Menu]→[Screens], or [Others>>]→[ECG Display] in the [ECG Setup] menu to choose the screen type as:

 [Normal]: The ECG waveform area shows 2 ECG waveforms.

 [Full-Screen]: The whole waveform area shows 7 ECG waveforms only.

 [12-Lead]: The whole waveform ares displays 12 ECG waveforms (for 12-lead set only).

When monitoring with a 3-lead set, the screen type can only be set to [Normal].

When the screen type is set to [Normal], cascaded ECG waveforms can be displayed.

To cascade ECG waveforms:

1. Select the [Main Menu]→[Screens]→[Screen Setup].


8.5.8 Setting the Notch Filter

The notch filter removes the line frequency interference. Only when [Filter] is set to [Diagnostic], the [Notch Filter] is adjustable.

To set the notch filter:

1. Select the ECG parameter window or waveform area to enter its setup menu. Then select [Others >>].



[Strong]: when waveform interference is strong (such as spikes).



[Weak]: when waveform interference is weak.



[Off]: to turn the notch filter off.

Set notch frequency according to the electric power frequency of your country. To set notch filter frequency: required password.

8.5.9 Changing the Pacer Reject Settings

To change the pacer reject settings, select [ECG Setup]→[Others>>]→[Pacer Reject], and then select [On] or [Off].

 When [Paced] is set to [Yes]:



When [Pacer Reject] is switched on, the pace pulses are not counted as extra QRS complexes.



The pace pulse marks “|” are shown on the ECG wave when pace pulses are detected.

 When [Paced] is set to [No], the pace markers are not shown on the ECG wave, and the options of [Pacer Reject] are inactivated.

8.5.10 Enabling Smart Lead Off

When the smart lead off function is enabled and there is a “lead off” in the lead of the first ECG wave, if another lead is available, the monitor will automatically select the available lead. The system will re-calculate HR and analyze and detect arrhythmia. When the “lead off” condition is corrected, the leads are automatically switched back.

To switch on/off the smart lead off function, select [Others >>] from the [ECG Setup] menu; select [Smart Lead Off] and then select [On] or [Off] from the pop-up menu.

8.5.11 Setting the Alarm Level for ECG Lead Off Alarms

Select [Alarm Setup >>] from the [User Maintenance] menu. You can set [ECGLeadOff Lev.] from the pop-up menu.


8.5.12 Adjusting QRS Volume

QRS sounds are produced based on the alarm source.

To adjust the QRS volume,

When a valid SpO

2

measured value is available, the system adjusts the pitch tone of QRS sound based on the SpO

2

value.

8.5.13 Adjusting the Minimum QRS Detection Threshold (For Advanced ECG Algorithm

Only)

To avoid false asystole alarms when the R wave amplitude is low and missed asystole alarms during ventricular standstill

(tall P waves, but no QRS), a means to manually adjust the minimum QRS detection threshold is provided.

To adjust the QRS threshold,

1. In the [ECG Setup] menu, set [Filter] to [Monitor].

2. Select [Others >>]→[Minimum QRS Threshold >>] to enter the [Minimum QRS Threshold] menu.

3. Select the up or down arrow to adjust the QRS threshold. Selecting [Default] resets the QRS threshold to the default value (0.16 mV).

CAUTION



The setting of QRS threshold can affect the sensitivity of arrhythmia, ST, QT/QTc detection, and heart rate calculation.



If QRS amplitude is low, the monitor might not be able to calculate heart rate and false asystole may occur.

NOTE



The minimum QRS detection threshold can only be adjusted when the ECG filter is set to [Monitor].


8.5.14 About the Defibrillator Synchronization

A synchronization pulse (100 ms, +5 V) is output through the multifunctional connector each time the monitor detects an R-wave.

To use the defibrillator synchronization function, connect the monitor and the defibrillator with a synchronization cable.

WARNING



Improper use of a defibrillator may cause injury to the patient. The user should determine whether to perform defibrillation or not according to the patient’s condition.

8.6 About ST Monitoring

 Mortara ST segment analysis is not intended for neonatal patients.

 ST segment analysis calculates ST segment elevations and depressions for individual leads and then displays them as numerics in the ST1 and ST2 areas.

 A positive value indicates ST segment elevation; a negative value indicates ST segment depression.

 Measurement unit of the ST segment deviation: mV or mm. You can set the unit in the [Unit Setup] menu from the

[User Maintenance] menu.

 Measurement range of the ST segment deviation: -2.0 mV to +2.0 mV.

WARNING



The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician.


8.6.1 Switching ST Monitoring On and Off

To switch ST monitoring on or off:

1. In the [ECG Setup] menu, select [ST Analysis >>].

Reliable ST monitoring cannot be ensured if:

 You are unable to get a lead that is not noisy.

 Arrhythmias such as atrial fib/flutter cause irregular baseline.

 The patient is continuously ventricularly paced.



The patient has left bundle branch block.

In these cases, you may consider switching ST monitoring off.

8.6.2 Changing ST Filter Settings

ST-segment analysis can be carried out only when the filter mode is set to [Diagnostic] or [ST]. When ST-segment analysis is switched on, [Filter] will automatically switch to [ST] if it is not [Diagnostic] or [ST]. When ST-segment analysis is switched off, the filter mode automatically switches to previous manual setting.

However, if you switch [Filter] to [Monitor] or [Surgery], ST-segment analysis will turn off automatically. If you change

[Monitor] or [Surgery] to [Diagnostic] or [ST], ST-segment analysis remains off, you can turn it on manually.

8.6.3 Understanding the ST Display

8.6.3.1 ST Numerics

This example shows ST numerics with 5-lead ECG. Your monitor screen may look slightly different from the illustration.

8.6.3.2 ST Segment

ST segment shows a QRS segment for each measured ST lead. The current ST segment is drawn in the same color as the

ECG wave, usually green, superimposed over the stored reference segment, drawn in a different color. The information is updated once every ten seconds.

To display the ST segment on normal screen:

1. Enter the [ST Analysis] menu. Set [ST Analysis] to [On].

2. Enter the [Screen Setup] window from the [Screens] menu. Set [ST Segment] to be displayed.


Select the ST parameter window or ST segment area to enter the [ST Analysis] menu.

8.6.4 Saving the Current ST Segment as Reference

Select [Save Ref.] in the [ST Analysis] menu to save the current segment as a reference. Up to 20 references segment groups can be saved.

NOTE



If the memory is full and you do not delete a group before saving a new one, the earliest saved group is deleted automatically.

8.6.5 Changing the Reference Segment

Select the and arrow keys beside the [Change Ref.] to switch between different reference segment groups.

8.6.6 Deleting a Reference Segment

Select [Delete Ref.] in the [ST Analysis] menu and then select [Ok] in the pop-up to delete the current ST reference segment.

8.6.7 Changing the ST Alarm Limits

High and low ST alarm limits can be set individually for each ECG lead. Alarm limits can also be set separately for single-lead and multi-lead ST monitoring. You can select [ST Alarm Setup >>] from [ST Analysis] menu and then change ST alarm settings for each lead.

8.6.8 Setting the ST Alarm Delay Time

To set the ST alarm delay time:

[Ok].


8.6.9 Adjusting ST Measurement Points

As shown in the figure below, the ST measured for each beat complex is the vertical difference between two measurement points with the R-wave peak as the baseline for the measurement.

R-wave peak

J point T

P

Q

Difference=ST value

Isoelectric point

ST measurement point

The ISO and ST points need to be adjusted when you start monitoring and if the patient’s heart rate or ECG morphology changes significantly. Exceptional QRS complexes are not considered for ST-segment analysis.

WARNING



Always ensure that the ST measurement points are appropriate for your patient.

To adjust the ST measurement points:

1.

Select the ECG numeric area or waveform area to enter the [ECG Setup] menu.

2.

Select [ST Analysis >>].

3.

Set [ST Analysis] to [On].

4.

Select [Adjust ST Point >>].

In the [Adjust ST Point] window, three vertical lines represent the ISO, J and ST point positions respectively. In this window, you can:

 Select [Auto] to automatically detect the ISO point and J point, and set ST point. When [Auto] is selected, the monitor takes a few seconds to finish automatic detection. During this time, the message [Please wait...] is displayed in the [Adjust ST Point] window.

 Or manually adjust the ISO point, J point, and ST point.

To manually adjust the ST measurement points, follow this procedure:

1.

Use the left and right arrows beside [ISO] and [J] to adjust the position of ISO point and J point.



The ISO-point (isoelectric) position is given relative to the R-wave peak. Position the ISO-point in the middle of the flattest part of the baseline (between the P and Q waves).



The J-point position is given relative to the R-wave peak and helps locating the ST-point. Position the J-point at the end of the QRS complex and the beginning of the ST segment.


2. Set [ST Point]. The ST-point is positioned a fixed distance from the J-point. Move the J-point to position the

ST-point at the midpoint of the ST segment. Position the ST-point relative to the J-point at either [J+60/80 ms],

[J+40 ms], [J+60 ms] or [J+80 ms]. When [J+60/80 ms] is selected, the ST-point will be positioned 80 ms (heart rate

120 bpm or less) or 60 ms (heart rate more than 120 bpm) from the J-point.

NOTE



Only Advanced ECG algorithm has the function of automatic J point detection.



The ISO point, J point, and ST point displayed in the [Adjust ST Point] window are positioned with reference to the R-wave peak.

8.7 QT/QTc Interval Monitoring (For Advanced ECG Algorithm Only)

The QT interval is defined as the time between the beginning of the Q-wave and the end of the T-wave. It measures the total duration of the depolarization (QRS duration) and repolarization (ST-T) phases of the ventricles. QT interval monitoring can assist in the detection of long QT syndrome.

The QT interval has an inverse relationship to heart rate. As heart rate increases, the QT interval shortens, while at lower heart rates QT interval gets longer. Several formulas are available to correct QT interval for heart rate. The heart rate corrected QT interval is abbreviated as QTc.

QT/QTc Interval Monitoring is intended for adult, pediatric, and neonate patients.

CAUTION

QT interval



For QT interval monitoring to be effective, basic or enhanced arrhythmia monitoring should be turned on.


8.7.1 QT/QTc Monitoring Limitations

Some conditions may make it difficult to achieve reliable QT monitoring, for example:

 R-wave amplitudes are too low

 The presence of frequent ventricular ectopic beats

 Unstable RR intervals

 P-waves tending to encroach on the end of the previous T-wave at high heart rates

 T-waves are very flat or not well defined The end of the T-wave is difficult to delineate because of the presence of

U-waves

 QTc measurements are not stable



In the presence of noise, asystole, ventricular fibrillation, and ECG lead off

For these cases you should select a lead with good T-wave amplitude and no visible flutter activity, and without a predominant U-wave or P-wave.

Some conditions such as left or right bundle branch block or hypertrophy can lead to a widened QRS complex. If a long

QTc is observed you should verify it to ensure that it is not caused by QRS widening.

Because normal beats followed by ventricular beats are not included in the analysis, no QT measurement will be generated in the presence of a bigeminy rhythm.

If the heart rate is extremely high (over 150bpm for adults and over 180bpm for pediatrics and neonates), QT will not be measured. When the heart rate changes, it can take several minutes for the QT interval to stabilize. For reliable QTc calculation it is important to avoid the region where the heart rate is changing.

WARNING



QT/QTc measurements should always be verified by a qualified clinician

8.7.2 Enabling QT/QTc Monitoring

To enable QT/QTc monitoring:

1. In the [ECG Setup] menu, select [QT Analysis>>] to enter the [QT Analysis] menu.


8.7.3 Displaying QT/QTc Parameters and Waveform

To display QT numerics and waveform:

1.

Select [Main Menu] →[Screens] to enter the [Screens] window

2.

Select the [Screen Setup] tab.

3． Select the parameter area where you want to display the QT parameters and select [QT].

NOTE



QTc values are calculated based on the QT-HR, not the ECG HR. To view the QT-HR, open the QT View window.

The following picture shows the QT numeric area. Your monitor screen may look slightly different:

2

1

3

4

5

4: QTc alarm limit (if QTc alarm is off, the alarm off symbol is displayed)

5: ΔQTc value (the difference between the current and reference QTc values. If ΔQTc alarm is off, the alarm off symbol is displayed on the right.)

NOTE



QTc values are calculated based on the QT-HR, not the ECG HR. To view the QT-HR, open the QT View window.

8.7.4 Accessing the QT View

QT View shows the current and reference QT parameter values and waveforms.

To access the QT View:

1. Select the QT parameter area or waveform area to enter the [QT Analysis] menu.


The following picture shows the QT view.

 The current waveform is shown in the upper half in green.

 The reference waveform is shown below in yellow.

 The start of QRS complex and the end of the T wave are marked with vertical lines.

 In some conditions, no QT measurement can be calculated. Then the cause of failed QT measurement is shown at the bottom of the QT numerics area. Additionally the message “Cannot Analyze QT” is shown in the technical alarm area.

In the QT View, you can:



Select the arrows besides [View Leads] to switch the displayed lead.



Select [Save Ref.] to save the current QT parameters and waveforms as reference. If no reference has been set for this patient within the first five minutes after getting valid QT values, the monitor will automatically set a reference. If you set a new reference, the previous reference will be discarded.

8.7.5 Changing QT Settings

8.7.5.1 Setting QT Alarm Properties

To set QT alarm properties,

1. Select

]

menu.

2. Set QTc and ΔQTc alarm properties.

8.7.5.2 Selecting the QT Analysis Lead

To select the QT analysis lead:


2. Set [Analysis Lead].

When [Analysis Lead] is set to [All]:



For 12-lead ECG, leads I, II, III, V2 and V5 are displayed.



For 5-lead ECG, leads I, II, III, and V are displayed.


8.7.6 Changing QTc Formula

The monitor uses as a default the Hodges correction formula to correct the QT interval for heart rate. To change the QTc formula:




Hodges:

QTc



QT



1 .

75





HeartRate



60





Bazett:

QTc



QT









HeartRate

60







1

2



Fridericia:

QTc



QT



HeartRate

60

1

3



Framingham:

QTc



QT



154







60

HeartRate







8.8 About Arrhythmia Monitoring

Arrhythmia analysis provides information about the patient's cardiac parameters like heart rate, PVC rate, and rhythm.

WARNING



Arrhythmia analysis program is intended to detect ventricular arrhythmias and atrial fibrillation. It is not designed to detect all the atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information with other clinical findings.





The arrhythmia detection is not intended for neonatal patients.

Heart-rate reading may be affected by cardiac arrhythmias. Do not rely entirely on rate meter alarms when monitoring patients with arrhythmias. Always keep these patients under close surveillance.



Atrial fibrillation (Afib) detection function is not intended for pediatric and neonatal patients.


8.8.1 Understanding the Arrhythmia Events

Mortara ECG algorithm

Arrhythmia Message

Asystole

Vfib

Vtac

PVCs

Pacer Not Pacing

Pacer Not Capture

Multif. PVC

Couplet

Run PVCs

Vent. Rhythm

Bigeminy

Trigeminy

R on T

Irr. Rhythm

Missed Beats

Brady

Tachy

Description

No QRS complex detected within the set time threshold (in absence of ventricular fibrillation or chaotic signals).

Ventricular fibrillation occurs and persists for 6 seconds.

Ventricular HR is greater or equal to the preset threshold and the number of consecutive PVCs is greater than the preset threshold.

PVCs/min exceeds high limit

No pace pulse detected for (60*1000/pace rate +90) milliseconds following a QRS complex or a pacer pulse (for paced patients only).

No QRS complex detected for 300 milliseconds following a pace pulse

(for paced patients only).

More than 2 PVCs of different forms occur in the predefined search window (3-31).

Paired PVCs are detected.

Ventricular HR is greater than or equal to the preset threshold and the number of PVCs is greater than or equal to 3 but less than the preset threshold.

Ventricular HR is less than the preset threshold and the number of PVCs is greater than or equal to 3.

A dominant rhythm of N, V,N, V, N, V.

A dominant rhythm of N, N, V,N, N, V, N, N, V.

R on T is detected.

Consistently irregular rhythm

No beat detected for 1.75x average R-R interval for HR <120, or

No beat for 1 second with HR >120 (for non-paced patients only), or

No beat detected for more than the set pause threshold.

The HR is less than the set bradycardia low limit.

The HR is greater than the set tachycardia high limit.

Category

Lethal arrhythmia

Nonlethal arrhythmia


Advanced ECG algorithm

Arrhythmia message

Asystole

Vfib/Vtac

Vtac

Vent. Brady

Extreme Tachy

Extreme Brady

PVCs

Pacer Not Pacing

Pacer Not Capture

PVC

Couplet

Run PVCs

Bigeminy

Trigeminy

R on T

Missed Beats

Brady

Tachy

Vent. Rhythm

Multif. PVC

Nonsus. Vtac

Pause

Irr. Rhythm

Afib

Description

No QRS detected within the set time threshold in absence of ventricular fibrillation or chaotic signal.

A fibrillatory wave for 6 consecutive seconds.

A dominant rhythm of adjacent Vs and a HR > the V-Tac HR limit.

The consecutive PVCs ≥ Vtac PVCs limit, and the HR ≥ the Vtac rate limit.

The consecutive PVCs ≥ the Vbrd threshold and the ventricular HR < the

Vbrd Rate threshold.

The heart rate is equal to or greater than the extreme tachycardia limit.

The heart rate is equal to or less than the extreme bradycardia limit.

PVCs/min exceeds high limit

No pace pulse detected for 1.75 x average R-to-R intervals following a

QRS complex (for paced patients only).

No QRS complex detected for 300 milliseconds following a pace pulse

(for paced patients only).

One PVC detected in normal heartbeats.

Paired PVCs detected in normal heartbeats.

More than 2 consecutive PVCs.

A dominant rhythm of N, V, N, V, N, V.

A dominant rhythm of N, N, V,N, N, V, N, N, V.

R on T detected in normal heartbeats.

No beat detected for 1.75 x average R-R interval for HR <120, or

No beat for 1 second with HR > 120 (for non-paced patients only), or

No beat detected for more than the set pause threshold.

The average heart rate is equal to or less than the bradycardia limit.

The average heart rate is equal to or greater than the tachycardia limit.

The consecutive PVCs ≥ the Vbrd PVCs limit, and the HR ≥ Vbrd Rate limit but < the Vtac Rate limit.

Multiform PVCs detected in Multif. PVC's Window (which is adjustable).

The consecutive PVCs < the Vtac PVCs limit but > 2, and HR ≥ the Vtac

Rate limit.

No QRS detected within the set time threshold of pause.

Category

Lethal arrhythmia

Nonlethal arrhythmia

Consistently irregular rhythm.

Absence of P-waves and/or variable RR intervals between normal beats.


8.8.2 Changing Arrhythmia Alarm Settings

To change arrhythmia alarm settings, select the ECG parameter area or waveform area →[ECG Setup]→ [Arrh.

Analysis >>]. In the pop-up menu, you can set the [Alm Lev] to [High], [Med], [Low] or [Message], or switch on lethal arrhythmia analysis alarms only or switch on/off all arrhythmia analysis alarms. In the [Alarm Setup] menu from the

[User Maintenance] menu, you can enable/disable turning off lethal arrhythmia analysis alarms.

WARNING



If you switch off all arrhythmia analysis alarms, the monitor cannot give any arrhythmia analysis alarm.

Always keep the patient under close surveillance.

NOTE



The priority of lethal arrhythmia alarms is always high. It is unchangeable.

8.8.3 Changing Arrhythmia Threshold Settings

Select the ECG parameter window or waveform area→[Arrh. Analysis >>]→[Arrh. Threshold], and you can then change threshold settings for some arrhythmia alarms. When an arrhythmia violates its threshold, an alarm will be triggered. The asystole delay time relates to ECG relearning. When HR is less than 30 bpm, it is recommended to set the asystole delay time to 10 seconds.


Arrh. event

PVCs High

Asys. Delay

Vtac Rate

Vtac PVC

Multif. PVC

Tachy High

Brady Low

Range

1 to 100

2 to 10

100 to 200

3 to 12

3 to 31

Adult: 100 to 300


Adult: 15 to 60

Pediatric: 15 to 80

Default

10

5

130

6

15

Adult: 100

Pediatric: 160

Adult: 60

Pediatric: 80

1

1

1

5

Step

1

Unit

/min s bpm beats beats

5 bpm

5 bpm



Arrh. event

PVCs High

Asys. Delay

Tachy High

Brady Low

Extreme Tachy

Extreme Brady

Multif. PVC's Window

Vtac Rate

Vtac PVCs

Range

1 to 100

3 to 10

60 to 300

15 to 120

120 to 300

15 to 60

3 to 31

100 to 200

3 to 99

Default

10

5

Adult: 120

Pediatric: 160

Neonate: 180

Adult: 50

Pediatric: 75

Neonate: 90

Adult: 160

Pediatric: 180

Neonate: 200

Adult: 35

Pediatric: 50

Neonate: 60

15

Adult, pediatric: 130

Neonate: 160

6

Step

1

Unit

/min

1 s

5 bpm

5 bpm

5 bpm

5 bpm

1 /min

5 bpm

1

Pause Time

Vbrd PVCs

Vbrd Rate

1.5, 2.0,2.5

3 to 99

15 to 60

2

5

40

/

1

5

8.8.4 Setting the Extended Arrhythmia (For Advanced ECG Algorithm Only)

The following arrhythmia events are defined as extended arrhythmia:

/min s

/min bpm

 Extreme Tachy

 Extreme Brady

 Vent. Brady

 Nonsus. Vtac

 Multif. PVC

 Irr. Rhythm

 Pause

 Afib

You can select [Main Menu]→[Maintenance >>]→[User Maintenance >>]→enter the required password→select

[Alarm Setup >>], and set [Extended Arrh.] to [Enable] or [Disable]. When [Extended Arrh.] is set to [Disable], the monitor does not analyze the extended arrhythmia events, and corresponding alarms are not given.

8.8.5 Reviewing Arrhythmia Events

Please refer to chapter 16 Review.


8.9 ECG Relearning

8.9.1 Initiating an ECG Relearning Manually

During ECG monitoring, you may need to initiate an ECG relearning when the patient’s ECG template changes dramatically. A change in the ECG template could result in:

 Incorrect arrhythmia alarms

 Loss of ST measurement, and/or

 Inaccurate heart rate

ECG relearning allows the monitor to learn the new ECG template so as to correct arrhythmia alarms and HR value, and restore ST measurements. To initiate relearning manually, select the ECG parameter window or waveform area→

[Relearn]. When the monitor is learning, the message [ECG Learning] is displayed in the technical alarm area.

WARNING



Initiate ECG relearning only during periods of normal rhythm and when the ECG signal is relatively noise-free. If ECG learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-Fib.

8.9.2 Automatic ECG Relearning

ECG relearning is initiated automatically whenever:

 The ECG lead or lead label is changed.

 The ECG lead is re-connected.

 A new patient is admitted.

 After ECG calibration is completed and [Stop Calibrating ECG] is selected.

 Switch between normal screen and 12-lead full screen for 12-lead ECG monitoring.

 The paced status of the patient is changed.


8.10 12-Lead ECG Monitoring

To access the 12-lead ECG monitoring screen:

1. Refer to section 8.3.3 ECG Lead Placements for placing the electrodes.

2. In the [ECG Setup] menu, select [Others>>] to enter the [Others Setup Menu].

There are a total of 12 ECG waves and 1 rhythm wave displayed on the screen. The rhythm lead is ECGⅠbefore entering the 12-lead ECG monitoring screen.

The [Filter] mode is automatically switched to diagnostic mode when the monitor accesses the 12-lead full-screen. The

[Filter] mode resumes to the configuration before accessing the 12-lead full screen when the monitor exits the 12-lead full screen.

8.10.1 Setting ECG Waveform Sequence

You can select the sequence of ECG waveforms on the 12-lead ECG screen and 12-lead ECG report.

To select the sequence of the ECG waveforms:




[Standard]: the sequence is I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6.



[Cabrera]: the sequence is aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, V6.

8.10.2 Extending the rhythm lead waveform area

To extend the height of the rhythm lead waveform area:



8.11 Resting 12-Lead ECG Analysis

The equipment incorporates the Glasgow algorithm, developed by the University of Glasgow, to provide an interpretation of the resting 12-lead ECG in all situations.

8.11.1 Accessing the 12-Lead Screen

To access the 12-lead screen:

1. In the [ECG Setup] menu, select [Others>>] to enter the [Other Setup Menu].

The functions of the keys at the bottom of the 12-lead screen are as follows:

 [Analyze]: starts resting 12-lead analysis.

 [Patient Info]: enters the patient information.

 [Setup]: enters the 12-lead setup menu.

 [Report]: prints the latest resting 12-lead report.

 [Exit]: exits the 12-lead sceen.

8.11.2 Entering Patient Information

Some patient information may directly affect ECG analysis. Complete and correct patient information is helpful for accurate diagnosis and treatment of the patient. Enter patient information before taking an ECG measurement.

To enter the patient information, select [Patient Demogr.] from the 12-lead screen.

NOTE



Check that patient information is correct before resting 12-lead analysis.



We recommend using pediatric lead placement V4R, V1, V2, V4 - V6 if the patient is under 16 years of age.

Please record V4R using the V3 electrode. Also set [V3 Electrode Placement] to [V4R]. This is a normal practice for a patient of this age.


8.11.3 12-Lead Setup

In the 12-lead screen, select [Setup] to enter the [12-Lead Setup] menu to change the settings related to 12-lead ECG analysis. In the [12-Lead Setup] menu, you can also select [Report Setup>>] to set the format and contents of the ECG reports.

12-lead Setup

Menu item

Brady Low

Option

40 - 60

Default

50

Description

Filter Diagnostic, Set filter mode.

ST

Note: The filter mode automatically switches to [Diagnostic] when the monitor accesses the 12-lead -screen and resumes to the original setting when the monitor exits the 12-lead screen.

Baseline Drift

Removal

On, Off On

Select whether the baseline drift removal (BDR) process or 0.05-Hz filter is used.

[On]: BDR is enabled. This process suppresses most baseline drift interference and also is able to preserve the fidelity of the ST-segment level.

[Off]: BDR is disabled and the 0.05-Hz filter is used.

NOTE: BDR or 0.05-Hz selection applies to the displayed ECG, printed report, analyzed and stored data.

BDR introduces around 1-second delay. We recommend use of BDR except when the delay is unacceptable.

Both BDR and 0.05-Hz selections meet requirements of the 1990 American

Heart Association Recommendations for Standardization and Specifications in Automated Electrocardiography: Bandwidth and Signal Processing pertaining to lower-frequency response in electrocardiography.

Tachy High 80 - 130 100 Adjusts tachycardia threshold. Heart rates above the setting are labeled

Tachycardia.

Only applies to patients whose age exceeds 180 days.

Adjusts bradycardia threshold. Heart rates below the setting are labeled

Bradycardia.

Only applies to patients whose age exceeds 2191 days.


QTc Formula

Waveform

Layout

Hodges,

Bazett,

Fridericia,

Framingham

Hodges

Standard,

Cabrera

Standard

Selects QTc formula.

Hodges:

QTc



QT



1 .

75





HeartRate



60



Bazett:

QTc



QT



HeartRate

60

1

2

Fridericia:

QTc



QT



HeartRate

60





1

3

Framingham:

QTc



QT



154







60

HeartRate







Select ECG lead sequence for displaying and printing.

[Standard]: the sequence is I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6.

[Cabrera]: the sequence is aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, V6.

Report setup

Menu item Option Default

Report Format 12×1, 6×2,

3×4+1

3×4+1

Median

Complex

Measurements

Interpretation

Interpretation

Summary

On, Off

On, Off

On, Off

On, Off

Off

On

On

On

Description

Selects the format of the 12-lead ECG report.

[12×1]: ECG waveforms are displayed in 12 lines.

[6×2]: ECG waveforms are displayed in 6 lines and 2 columns.

[3×4+1]: ECG waveforms are displayed in 3 lines and 4 columns followed by the rhythm lead waveform.

Selects whether Median Complex is included on the 12-lead ECG report.

Median Complex displays a median complex waveform for each lead and a rhythm lead waveform of 10 seconds in 3x4+1 format. For each waveform, short vertical lines are used to mark the start of the P-wave and QRS complex, and the end of the P-wave, QRS complex, and T-wave.

Selects whether the measurement result is included on the 12-lead ECG report.

Measurement result includes Vent. Rate, PR Interval, QRS Duration, QT/QTc

Interval, and P/QRS/T Axes.

Selects whether diagnoses are included on the 12-lead ECG report.

Selects whether interpretation summary is included on the 12-lead ECG report.

Note: If the [Interpretation] option is not enabled, interpretation summary is not included on the report even if [Interpretation Summary] is enabled.


8.11.4 Resting 12-lead ECG Analysis

Before 12-lead ECG interpretation, check that all electrodes are correctly connected to the lead wires and the ECG trunk cable is properly connected. Check that patient information is correct.

To start analyzing, select the [Analyze] key. The resting 12-lead analysis takes about 10 seconds. During this period, keep the patient still.

After analysis finishes, the following dialog-box pops out.

Select [Print Report] to pint the resting 12-lead ECG report from the external printer.

You can also print the latest 12-lead ECG report by selecting [Report] from the 12-lead screen.

Refer to12-Lead ECG Interpretive Program Physician’s Guide (PN: 046-006360-00) for details.

CAUTION



During the resting 12-lead ECG analysis, keep the patient still. Patient movement may cause misdiagnosis.

NOTE



Glasgow resting 12-lead ECG intepretation is applied to adult, pediatric and neonate.



During 12-lead ECG analaysis, 12-lead related settings are disabled.



Changing patient information, including the patient’s age, date of birth, gender, race, medication, class, or

V3 placement setting,may change diagnosis statement. You shall select the [Analyze] key to reanalyze the patient’s ECG before you print the latest 12-lead ECG report.


8.11.5 12-lead ECG Report

The format and contents of the 12-lead ECG report are configurable. Refer to Report Setup in 8.11.312-Lead Setup for details.

The following is a sample of the12-lead ECG report with default configuration.

1

2 3 4

5 6 7

2. Time of resting 12-lead ECG analysis

3. Measurements

8. System software version/algorithm version


8

8-29

8.12 Troubleshooting

This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists, contact your service personnel.

CAUTION



Never try to disassemble the equipment or supplied accessories. There are no internal user-serviceable parts.

Symptoms

Noisy ECG traces

Possible Cause

Loose or dry electrodes

Correction Action

Apply fresh and moist electrodes.

Defective electrode wires Replace wires if necessary.

Excessive Electro-surgical

Interference

Muscle Noise

Intermittent Signal

Excessive alarms: heart rate, lead fault

Low Amplitude ECG Signal

Patient cable or leads are routed too close to other electrical devices

Wrong ECG cable used

Inadequate skin preparation prior to application of electrode, tremors, tense subject, and/or poor electrode placement

Move the patient cable or leads away from the electrical device.

Use ESU-proof ECG cables. For details, refer to section 23.1 ECG Accessories.

Repeat skin preparation as described in section

8.3.1 Preparing the Patient and Placing the

Electrodes and re-place the electrodes.

Apply fresh, moist electrodes.

Avoid muscular areas.

Check that the cables are properly connected. Connections not tight and/or properly secured

Electrodes dry or loose

Cable or lead wires damaged

Electrodes dry

Excessive patient movement or muscle tremor

Gain set too low

Electrodes dry / old

Skin improperly prepared



Electrodes and apply fresh and moist electrodes.

Change cable and lead wires.



Electrodes and apply fresh, moist electrodes.

Reposition the electrodes.

Replace fresh and moist electrodes if necessary.

Set the gain as required. For details, refer to section

8.5.4 Changing ECG Wave Settings.

Apply fresh and moist electrodes.



Electrodes.

Verify with another well-functioning monitor. This could be the patient’s normal QRS complex

Electrode could be positioned over a bone or muscle mass

Move ECG patches away from the bone or muscle mass.


Symptoms

No ECG Waveform

Base Line Wander

Possible Cause

Gain set too low

Lead wires and patient cable not fully or properly inserted

Cable or lead wires damaged

Patient moving excessively

Electrodes dry or loose

ECG Filter set to ST or Diagnostic mode


Set the gain as required. For details, refer to section

8.5.4 Changing ECG Wave Settings.

Check that the leadwires and patient cables are properly connected.

Change cable and lead wires.

Secure leadwires and cable to patient.



Electrodes and apply fresh and moist electrodes.

Set ECG Filter to “Monitor” mode.


FOR YOUR NOTES


9

Monitoring Respiration (Resp)


Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the monitor screen.

9.2 Safety Information

Warning







The respiration measurement does not recognize the cause of apneas. It only indicates an alarm if no breath is detected when a pre-configured time has elapsed since the last detected breath. Therefore, it cannot be used for diagnostic purpose.



When monitoring the patient’s respiration, do not use ESU-proof ECG cables.

If you do not set the detection level for the respiration correctly in manual detection mode, it may not be possible for the monitor to detect apnea. If you set the detection level too low, the monitor is more likely to detect cardiac activity, and to falsely interpret cardiac activity as respiratory activity in the case of apnea.

If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated Immunity 3V/m), field strengths above 1V/m may cause erroneous measurements at various frequencies. Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit.

9.3 Understanding the Resp Display

1 2

3

4

1. Gain

2. Resp lead label

By selecting the waveform area or parameter area, you can enter the [Resp Setup] menu.

NOTE



Respiration monitoring is not for use on the patients who are very active, as this will cause false alarms.


9.4 Placing Resp Electrodes

As the skin is a poor conductor of electricity, preparing the skin is necessary for a good respiration signal. You can refer to the ECG section for how to prepare the skin. For details, refer to section 8.3.1 Preparing the Patient and Placing the

Electrodes.

As the respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables (3-lead,

5-lead or 12-lead). Since the respiration signal is measured between two ECG electrodes, if a standard ECG electrode placement is applied, the two electrodes should be RA and LA of ECG Lead I, or RA and LL of ECG Lead II.

NOTE



To optimize the respiration waveform, place the RA and LA electrodes horizontally when monitoring respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with

ECG Lead II.

Lead I Lead II

9.4.1 Optimizing Lead Placement for Resp

If you want to measure Resp and you are already measuring ECG, you may need to optimize the placement of the two electrodes between which Resp will be measured. Repositioning ECG electrodes from standard positions results in changes in the ECG waveform and may influence ST and arrhythmia interpretation.

9.4.2 Cardiac Overlay

Cardiac activity that affects the Resp waveform is called cardiac overlay. It happens when the Resp electrodes pick up impedance changes caused by the rhythmic blood flow. Correct electrodes placement can help to reduce cardiac overlay: avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. This is particularly important for neonates.


9.4.3 Abdominal Breathing

Some patients with restricted movement breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimise the respiratory wave.

9.4.4 Lateral Chest Expansion

In clinical applications, some patients (especially neonates) expand their chests laterally, causing a negative intrathoracic pressure. In these cases, it is better to place the two respiration electrodes in the right midaxillary and the left lateral chest areas at the patient’s maximum point of the breathing movement to optimise the respiratory waveform.

9.5 Choosing the Respiration Lead

In the [Resp Setup] menu, set [Resp Lead] to [I], [II] or [Auto].

9.6 Changing the Apnea Alarm Delay

The apnea alarm is a high-level alarm used to detect apneas. You can set the apnea alarm delay time after which the monitor alarms if the patient stops breathing.

To change the apnea alarm delay:

1. In the [Resp Setup] menu, select [Apnea Delay].

2. Select the appropriate setting.

The [Apnea Delay] of Resp and CO

2

module keeps consistent with each other.

9.7 Changing Resp Detection Mode

In the [Resp Setup] menu, select [Detection Mode] and then select [Auto] or [Manual].

 In auto detection mode, the monitor adjusts the detection level automatically, depending on the wave height and the presence of cardiac artifact. Note that in auto detection mode, the detection level (a dotted line) is not displayed on the waveform.

Use auto detection mode for situations where:



The respiration rate is not close to the heart rate.



Breathing is spontaneous, with or without continuous positive airway pressure (CPAP).



Patients are ventilated, except patients with intermittent mandatory ventilation (IMV).

 In manual detection mode, you adjust the dotted detection level line to the desired level by selecting [Upper Line] or [Lower Line] and then selecting the or beside them. Once set, the detection level will not adapt automatically to different respiration depths. It is important to remember that if the depth of breathing changes, you may need to change the detection level.


Use manual detection mode for situations where:



The respiration rate and the heart rate are close.



Patients have intermittent mandatory ventilation.



Respiration is weak. Try repositioning the electrodes to improve the signal.

In Auto Detection Mode, if you are monitoring Resp and ECG is switched off, the monitor cannot compare the ECG and

Resp rates to detect cardiac overlay. The respiration detection level is automatically set higher to prevent the detection of cardiac overlay as respiration.

In Manual Detection Mode, cardiac overlay can in certain situations trigger the respiration counter. This may lead to a false indication of a high respiration or an undetected apnea condition. If you suspect that cardiac overlay is being registered as breathing activity, raise the detection level above the zone of cardiac overlay. If the Resp wave is so small that raising the detection level is not possible, you may need to optimize the electrode placement as described in section 9.4.4 Lateral Chest Expansion.

9.8 Changing Resp Wave Settings

WARNING



When monitoring in manual detection mode, make sure to check the respiration detection level after you have increased or decreased the size of the respiration wave.

In the [Resp Setup] menu, you can:

 Select [Gain] and then select an appropriate setting. The bigger the gain is, the larger the wave amplitude is.

 Select [Sweep] and then select an appropriate setting. The faster the wave sweeps, the wider the wave is.

9.9 Setting Respiration Rate (RR) Source

To set RR source:

1. Enter the [Resp Setup] menu.

The dropdown list displays the currently available RR source. When you select [Auto], the system will automatically select the RR source according to the priority. When the current RR source does not have valid measurement, the system will automatically switch the [RR Source] to [Auto]. RR source switches back to impedance respiration if you press the

QuickKey during an apnea alarm.


The RR source options and description are shown in the table below.

Option

Auto

CO

2

ECG

Description

RR source is automatically selected according to the priority.

RR source is from CO

2

measurement.

RR source is from impedance respiration measurement.

9.10 Setting Alarm Properties

Select [Alarm Setup >>] from the [Resp Setup] menu. In the pop-up menu, you can set alarm properties for this parameter.


FOR YOUR NOTES


10

Monitoring PR


The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart. You can display a pulse from any measured SpO

2 or any arterial pressure (see chapter 14 Monitoring IBP). The displayed pulse numeric is color-coded to match its source.

PR value

NOTE



A functional tester or SpO

2

simulator can be used to determine pulse rate accuracy.

10.2 Setting the PR Source

The current pulse source is displayed in the PR parameter area. The pulse rate chosen as pulse source:

 is monitored as system pulse and generates alarms when you select PR as the active alarm source;

 is stored in the monitor’s database and reviewed in the graphic/tabular trends; in trend graphs, as the PR curve is in the same color with the PR source , it is unlikely to distinguish the PR source;

 is sent via the network to the CMS, if available.

To set which pulse rate as PR source:

1. Enter the [SpO

2

Setup] menu.

The pop-up menu displays the currently available PR sources from top to bottom by priority. When you select [Auto], the system will automatically select the first option as the PR source from the pop-up menu. When the current PR source is unavailable, the system will automatically switch [PR Source] to [Auto]. When you select [IBP], the system will automatically select the first pressure label as the PR source from the pop-up menu.


10.3 Selecting the Active Alarm Source

In most cases the HR and pulse numerics are identical. In order to avoid simultaneous alarms on HR and PR, the monitor uses either HR or PR as its active alarm source. To change the alarm source, select [Alm Source] in the [ECG Setup] or

[SpO

2

Setup] menu and then select either:

 [HR]: The monitor will use the HR as the alarm source for HR/pulse.

 [PR]: The monitor will use the PR as the alarm source for HR/pulse.



[Auto]: If the [Alm Source] is set to [Auto], the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and a valid heart rate is available. If the heart rate becomes unavailable, for example if leads become disconnected, and a pulse source is switch on and available, the monitor will automatically switch to Pulse as the alarm source. When the Leads Off condition is corrected, the monitor will automatically switch back to the heart rate as the alarm source.

10.4 QRS Tone

When PR is used as the alarm source, the PR source will be used as a source for the QRS tone. You can change the QRS volume by adjusting [Beat Vol] in the [SpO2 Setup] menu. When a valid SpO

2

value exists, the system will adjust the pitch tone of QRS volume according to the SpO

2

value.


11

Monitoring SpO

2


SpO

2

monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into electrical signals by the photo detector in the probe. The SpO

2

module processes the electrical signal and displays a waveform and digital values for SpO

2

and pulse rate.

This device is calibrated to display functional oxygen saturation.

2 3

5

1 4

1. Pleth waveform (Pleth): visual indication of patient’s pulse. The waveform is not normalized.

2. Oxygen saturation of arterial blood (SpO

2

): percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin.

3. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.

4. Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to assess the quality of SpO

2

measurement.



Above 1 is optimal.



Between 0.3 and 1 is acceptable.



Below 0.3 indicates low perfusion. When PI is below 03, a question mark (?) is displayed to the right of the SpO

2 value, indicating that SpO

2

value may be inaccurate. Reposition the SpO

2

sensor or find a better site. If low perfusion persists, choose another method to measure oxygen saturation if possible.

PI is available for Masimo SpO

2

module.


5. Pulse rate (derived from the pleth wave): detected pulsations per minute.

NOTE



A functional tester or SpO

2

simulator cannot be used to assess the accuracy of a SpO

2

module or a SpO

2 sensor.

11.2 Safety

WARNING







Use only SpO

2

sensors specified in this manual. Follow the SpO

2

sensor’s instructions for use and adhere to all warnings and cautions.



When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition.

The equipment is not intended for use in an MRI environment.

Prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the sensor if the skin quality changes. Change the application site every four hours. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.

11.3 Identifying SpO

2

Modules

To identify which SpO

2 module is incorporated into your monitor, see the color of the connector and the company logo located at the right upper corner. The color of the cable connector matches the company as shown below:

 Masimo SpO

2

module: a white connector with a logo of Masimo SET.

 Nellcor SpO

2

module: a grey connector with a logo of Nellcor.

The connectors for these SpO

2

sensors are mutually exclusive.

11.4 Applying the Sensor

To apply the sensor:

1. Select an appropriate sensor according to the module type, patient category and weight.

2. Remove colored nail polish from the application site.

3. Apply the sensor to the patient.

4. Select an appropriate adapter cable according to the connector type and plug this cable into the monitor.

5. Connect the sensor cable to the adapter cable.


WARNING



If the sensor is too tight because the application site is too large or becomes too large due to edema, excessive pressure for prolonged periods may result in venous congestion distal from the application site, leading to interstitial edema and tissue ischemia.

11.5 Changing SpO

2

Settings

11.5.1 Accessing SpO2 Menus

By selecting the SpO

2

parameter window or waveform area, you can access the [SpO2 Setup] menu.

11.5.2 Adjusting the Desat Alarm

The desat alarm is a high level alarm notifying you of potentially life threatening drops in oxygen saturation. Select

[Alarm Setup >>] from the [SpO2 Setup] menu. From the pop-up menu, you can set low alarm limit, alarm switch, and alarm recording for [Desat]. When the SpO

2

value is below the desat alarm limit and desat alarm switch is set on, the message [SpO2 Desat] is displayed.

11.5.3 Setting SpO2 Sensitivity

For Masimo SpO

2

module, you can set [Sensitivity] to [Normal] or [Maximum] in the [SpO2 Setup] menu. When the

[Sensitivity] is set to [Maximum], the monitor is more sensitive to minor signals. When monitoring critically ill patients whose pulsations are very weak, it is strongly recommended that the sensitivity is set to [Maximum]. When monitoring neonatal or non-critically ill patients who tend to move a lot, noise or invalid signals may be caused. In this case, it is recommended that the sensitivity is set to [Normal] so that the interference caused by motion can be filtered and therefore the measurement stability can be ensured.

11.5.4 Changing Averaging Time

The SpO

2

value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patient’s oxygen saturation level. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patient’s oxygen saturation level, but the measurement accuracy will be improved. For critically ill patients, selecting shorter averaging time will help understanding the patient’s state.

To set the averaging time for Masimo SpO

2

module:

2. Then select [2-4 s], [4-6 s], [8 s], [10 s], [12 s], [14 s] or [16 s].


11.5.5 Monitoring SpO2 and NIBP Simultaneously

When monitoring SpO

2

and NIBP on the same limb simultaneously, you can switch [NIBP Simul] on in the [SpO2 Setup] menu to lock the SpO

2

alarm status until the NIBP measurement ends. If you switch [NIBP Simul] off, low perfusion caused by NIBP measurement may lead to inaccurate SpO

2

readings and therefore cause false physiological alarms.

11.5.6 Sat-Seconds Alarm Management

With traditional alarm management, high and low alarm limits are set for monitoring oxygen saturation. During monitoring, as soon as an alarm limit is violated, an audible alarm immediately sounds. When the patient % SpO

2 fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarms can be distracting.

Nellcor’s Sat-Seconds alarm management technique is used to reduce these nuisance alarms.

The Sat-Seconds feature is available with the Nellcor SpO

2

module to decrease the likelihood of false alarms caused by motion artifacts. To set the Sat-Seconds limit, select [Sat-Seconds] in the [SpO2 Setup] menu and then select the appropriate setting.

With Sat-Seconds alarm management, high and low alarm limits are set in the same way as traditional alarm management. A Sat-Seconds limit is also set. The Sat-Seconds limit controls the amount of time that SpO

2

saturation may be outside the set limits before an alarm sounds. The method of calculation is as follows: the number of percentage points that the SpO

2

saturation falls outside the alarm limit is multiplied by the number of seconds that it remains outside the limit. This can be stated as the equation:

Sat-Seconds= Points × Seconds

Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. For example, the figure below demonstrates the alarm response time with a Sat-Seconds limit set at 50 and a low SpO

2

limit set at 90%. In this example, the patient % SpO

2 drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to 84% (6 points) for 6 seconds. The resulting Sat-Seconds are:

% SpO

2

Seconds Sat-Seconds

2× 2= 4

4× 3= 12

6× 6= 36

Total Sat-Seconds= 52


After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50 Sat-Seconds would have been exceeded.

SpO

2

Seconds

Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, the patient % SpO

2 may fluctuate above and below an alarm limit, re-entering the non-alarm range several times. During such fluctuation, the monitor integrates the number of %SpO

2

points, both positive and negative, until either the Sat-Seconds limit is reached, or the patient %SpO

2

re-enters the non-alarm range and remains there.

NOTE



The “SpO

2

Too Low” or “SpO

2

Too High” alarm is presented in the case that SpO

2 value violates the alarm limits for 3 times within one minute even if the setting of Sat-Seconds is not reached.

11.5.7 Changing the Speed of the Pleth Wave

In the [SpO2 Setup] menu, select [Sweep] and then select the appropriate setting. The faster the waveform sweeps, the wider the waveform is.

11.5.8 Zooming PI Value (Only Available with the External Display)

For Masimo SpO

2

module, you can display PI value in larger characters for better view. To zoom in the display of PI value, set [PI Zoom] to [Yes] from the [SpO2 Setup] menu on the external display.

11.5.9 Setting the Alarm Level for SpO2 Sensor Off Alarm

Select [Alarm Setup >>] from the [User Maintenance] menu. You can set the [SpO2SensorOff Lev.] in the pop-up menu.

11.5.10 Setting the SpO2 Tone Mode

Select [Others >>] from the [User Maintenance] menu. In the pop-up menu, you can set [SpO2 Tone] as [Mode 1] or

[Mode 2].


WARNING



The same SpO

2

tone mode shall be used for the same patient monitors in a single area.

11.6 Measurement Limitations

If you doubt the SpO

2

, measurement, check the patient’s vital signs first. Then check the patient monitor and SpO

2

sensor.

The following factors may influence the accuracy of measurement:

 Ambient light

 Physical movement (patient and imposed motion)

 Diagnostic testing

 Low perfusion

 Electromagnetic interference, such as MRI environment

 Electrosurgical units

 Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin (MetHb)

 Presence of certain dyes, such as methylene and indigo carmine

 Inappropriate positioning of the SpO

2

sensor, or use of incorrect SpO

2

sensor

 Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor.

11.7 Masimo Information

 Masimo Patents

This device is covered under one or more the following U.S.A. patents: 5,758,644, 6,011,986, 6,699,194, 7,215,986,

7,254,433, 7,530,955and other applicable patents listed at: www.masimo.com/patents.htm.

 No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.


11.8 Nellcor Information

 Nellcor Patents

This device may be covered by one or more of the following US patents and foreign equivalents: 5,485,847, 5,676,141,

5,743,263, 6,035,223, 6,226,539, 6,411,833, 6,463,310, 6,591,123, 6,708,049, 7,016,715, 7,039,538, 7,120,479, 7,120,480,

7,142,142, 7,162,288, 7,190,985, 7,194,293, 7,209,774, 7,212,847, 7,400,919.

 No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.



CAUTION





Symptoms

Dashes “- -” display in place of numerics.

Do not see SpO

2 tiles in display.

parameter

Possible Cause

Measurement is invalid.


Check that the sensor is properly applied. Change the application site if necessary.

Parameter not configured to display.

Switch the SpO

2 monitoring function on as described in section 3.10.1 Switching the

Parameters On/Off.

Unable to obtain SpO

2

reading Patient has poor perfusion

Sensor not on patient

Switch limbs/notify physician

Check if the [SPO2 Sensor Off] alarm is reported.

Cables loose/not connected

Ambient light

If so, reapply the sensor.

If not, contact the service personnel.

Check connections, switch cable

Check if the [SpO2 Too Much Light] alarm is

No SpO2 waveform

Low amplitude SpO

2

Waveform not selected to display

Cable or sensor not plugged in signal SpO

2

sensor on same limb as cuff

Patient has poor perfusion reported. If so, move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light.

Switch the SpO

2

monitoring function on as described in section 3.10.1 Switching the

Parameters On/Off.

Check that the cable is properly connected and sensor securely applied.

Check that the sensor is properly applied. Change the application site if necessary.

Change the application site.


12

Monitoring NIBP


The monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). This measurement can be used for adults, pediatrics and neonates.

Automatic non-invasive blood pressure monitoring uses the oscillometric method of measurement. To understand how this method works, we’ll compare it to the auscultative method. With auscultation, the clinician listens to the blood pressure and determines the systolic and diastolic pressures. The mean pressure can then be calculated with reference to these pressures as long as the arterial pressure curve is normal.

Since the monitor cannot hear the blood pressure, it measures cuff pFressure oscillation amplitudes. Oscillations are caused by blood pressure pulses against the cuff. The oscillation with the greatest amplitude is the mean pressure. This is the most accurate parameter measured by the oscillometric method. Once the mean pressure is determined, the systolic and diastolic pressures are calculated with reference to the mean.

Simply stated, auscultation measures systolic and diastolic pressures and the mean pressure is calculated. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.

As specified by IEC 80601-2-30, NIBP measurement can be performed during electro-surgery and discharge of defibrillator.

NIBP diagnostic significance must be decided by the clinician who performs the measurement.

NOTE



Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method or an intra-arterial blood pressure measurement device, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers.


12.2 Safety

WARNING



Be sure to select the correct patient category setting for your patient before measurement. Do not apply the higher adult settings for pediatric or neonatal patients. Otherwise it may present a safety hazard.



Do not measure NIBP on patients with sickle-cell disease or on the limb where skin damage has occurred or is expected.



Use clinical judgment to determine whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.



Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.



NIBP reading can be affected by the measurement site, the position of the PATIENT, exercise, or the patient's physiologic condition. If you doubt the NIBP measurements, determine the patient’s vital signs by alternative means and then verify that the monitor is working correctly.



Do not apply cuff on the arm on the side of a mastectomy.


Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm, or if the patient is on a heart-lung machine.

The measurement may be inaccurate or impossible:

 If a regular arterial pressure pulse is hard to detect



With excessive and continuous patient movement such as shivering or convulsions



With cardiac arrhythmias

 Rapid blood pressure changes

 Severe shock or hypothermia that reduces blood flow to the peripheries

 Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery

12.4 Measurement Methods

There are three methods of measuring NIBP:

 Manual: measurement on demand.

 Auto: continually repeated measurements at set intervals.



STAT: continually rapid series of measurements over a five minute period, then return to the previous mode.


12.5 Setting Up the NIBP Measurement

12.5.1 Preparing the Patient

In normal use, perform NIBP measurement on a patient who is in the following position:

 Comfortably seated

 Legs uncrossed

 Feet flat on the floor

 Back, arm and feet supported

 Middle of the cuff at the level of the right atrium of the heart

NOTE







It is recommended that the patient relaxes as much as possible before performing measurement and that the patient do not talk during measurement.



To avoid unnecessary motion artifact, it is recommended to have the patient sit quietly for several minutes before taking the measurement.

The operator shall not touch the cuff or tubing during NIBP measurement.

Other factors that have been shown to result in an overestimation of blood pressure are labored breathing, full bladder, pain etc.

12.5.2 Preparing to Measure NIBP

To prepare for the NIBP measurement:

1. Power on the monitor.

2. Verify that the patient category is correct. If not, select [Main Menu]→ [Patient Setup]→ [Patient Demographics]

→ [Patient Cat.] and set the patient category to [Adu], [Ped] or [Neo].

3. Plug the air tubing into the NIBP connector on the monitor.

4. Select a correct sized cuff and then wrap it directly over the patient’s skin as follows:



Determine the patient’s limb circumference.



Select an appropriate cuff by referring to the limb circumference marked on the cuff. The width of the cuff should be 40% (50% for neonates) of the limb circumference, or 2/3 of the upper arm’s length. The inflatable part of the cuff should be long enough to encircle at least 50% to 80% of the limb.



Apply the cuff to the patient’s upper arm or leg and make sure the Φ marking on the cuff matches the artery location. The cuff should fit snugly, but with enough room for two fingers to be placed between the cuff and the patient’s arm (on adults), and loosely on neonates with little or no air present within the cuff. It may cause discoloration, and ischemia of the extremities. Make sure that the cuff edge falls within the marked range. If it does not, use a cuff that fits better.

5. Connect the cuff to the air tubing. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing.


WARNING



Continuous cuff pressure due to connection tubing kinking may cause blood flow interference and resulting harmful injury to the patient.

NOTE



Equipment use is restricted to one patient at a time.

12.5.3 Starting and Stopping Measurements

Select the on-screen QuickKey or [Main Menu]→[NIBP Measure] to start an NIBP measurement. You can select

[Stop NIBP] in the main menu to stop NIBP measurements.

12.5.4 Correcting the Measurement if Limb is not at Heart Level

The cuff should be applied to a limb at the same level as the patient’s heart. If the limb is not at the heart level, to the displayed value:

 Add 0.75 mmHg (0.10 kPa) for each centimetre higher, or

 Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower.

12.5.5 Enabling NIBP Auto Cycling and Setting the Interval

To enable the NIBP auto cycling and set and interval:

1. Select the NIBP parameter window to enter the [NIBP Setup] menu.

3. Start a measurement manually. The monitor will then automatically repeat NIBP measurements at the set time interval.

12.5.6 Enabling Measurement on Clock

In auto measurement mode, if the clock is enabled, the monitor automatically synchronizes NIBP automatic measurements with the real time clock. For example, if [Interval] is set to [20 min], and you start NIBP auto measurement at 14: 03, the next measurement will be taken at 14: 20, and then at 14:40, 15:00, and so on.

To enable measurement on clock:

1.

Select the NIBP parameter window to enter the [NIBP Setup] menu.

2.

Set [Clock] to [On].


NOTE



The measurement on clock feature is only available for patient monitors supporting Advanced ECG algorithm.



Measurement on clock is effective only when NIBP Interval is set to [5min] or an option greater than 5 min.

12.5.7 Starting a STAT Measurement

To start a STAT measurement:

1. Select the NIBP parameter window to enter the [NIBP Setup] menu.

WARNING



Continuous non-invasive blood pressure measurements may cause purpura, ischemia and neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the cuffed limb for normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to another site or stop the blood pressure measurements immediately.

12.6 Understanding the NIBP Numerics

The NIBP display shows numerics only as below. Your display may be configured to look slightly different.

1 2

3

3. Mean pressure obtained after the measurement and cuff pressure obtained during the measurement

If the NIBP measurement exceeds the measurement range, “---” will be displayed.


12.7 Changing NIBP Settings

By selecting the NIBP parameter window, you can enter the [NIBP Setup] menu.

12.7.1 Setting the Initial Cuff Inflation Pressure

You can set the initial cuff inflation pressure manually. In the [NIBP Setup] menu, select [Initial Pressure] and then select the appropriate setting.

NOTE



For known hypertensive patients, you need to set initial cuff pressure to a higher value to reduce the measurement time.

12.7.2 Setting NIBP Alarm Properties

Select [Alarm Setup >>] from the [NIBP Setup] menu. You can set the alarm properties for this parameter in the pop-up menu.

12.7.3 Displaying NIBP List

Select [Main Menu]→[Screens]→[Screen Setup]. You can set [NIBP List] to be displayed at the bottom area of the screen, where the most recent NIBP measurements display. Then, multiple sets of most recent NIBP measurements will be displayed. And the displayed PR is derived from NIBP.

You can display NIBP list only in normal screen.

12.7.4 Setting the Pressure Unit

Select [Unit Setup >>] from the [User Maintenance] menu. In the pop-up menu, select [Press. Unit] and then select

[mmHg] or [kPa].

12.7.5 Switching On NIBP End Tone

The monitor can issue a reminder tone at the completion of NIBP measurement. The NIBP End Tone is off by default. You can switch it on by accessing the [NIBP Setup] menu.


12.8 Assisting Venous Puncture

You can use the NIBP cuff to cause sub-diastolic pressure to block the venous blood vessel and therefore help venous puncture. appropriate. Change it if necessary.

3. Puncture vein and draw blood sample.

4. Select the on-screen QuickKey to deflate the cuff. The cuff deflates automatically after a set time if you do not deflate it.

During measurement, the NIBP display shows the inflation pressure of the cuff and the remaining time in venous puncture mode.


13

Monitoring Temp


The equipment is used to monitor skin temperature and core temperature. It can simultaneously monitor two temperature sites.

13.2 Safety

WARNING



Verify that the probe detection program works correctly before monitoring. Remove the temperature probe cable from the T1 or T2 connector, and the monitor can display the message [T1 Sensor Off] or [T2 Sensor

Off] and give alarm tones correctly.

13.3 Taking a Temp Measurement

To take a Temp measurement:

1. Select an appropriate probe for your patient according to the patient type and measuring site.

2. If you are using a disposable probe, connect the probe to the temperature cable.

3 Plug the probe or temperature cable to the temperature connector.

4. Correctly attach the probe to the patient.

5. Check that the alarm settings are appropriate for this patient.


13.4 Understanding the Temp Display

The temperature monitoring is displayed on the monitor as three numerics: T1, T2 and TD. By selecting this area, you can enter the [Alarm Setup] menu.

13.5 Setting the Temperature Unit

Select [Unit Setup >>] from the [User Maintenance] menu. In the pop-up menu, select [Temp Unit] and then select [ºC] or [ºF].


14

Monitoring IBP


The monitor can monitor two invasive blood pressures and displays the systolic, diastolic and mean pressures and a waveform for each pressure.

14.2 Safety

WARNING







Use only pressure transducers specified in this manual. Never reuse disposable pressure transducers.

Make sure that the applied parts never contact other conductive parts.

To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitor’s cables and transducers never come into contact with the high-frequency surgical units.



When using accessories, their operating temperature should be taken into consideration. For details, refer to instructions for use of accessories.



The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result.


14.3 Zeroing the Transducer

To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy (at least once per day).

Zero whenever:

 A new transducer or adapter cable is used.

 You reconnect the transducer cable to the monitor.

 The monitor restarts.



You doubt the readings.

To zero the transducer:

1. Turn off the stopcock to the patient.

Pressure transducer

3-way stopcock

Pressure adapter cable

Monitor

2. Vent the transducer to the atmospheric pressure by turning on the stopcock to the air.

3. In the setup menu for the pressure (e.g. Art), select [Art Zero >>]→[Zero]. During zero calibration, the [Zero] button appears dimmed. It recovers after the zero calibration is completed.

4. After the zero calibration is completed, close the stopcock to the air and open the stopcock to the patient.

NOTE



Your hospital policy may recommend that the ICP transducer is zeroed less frequently than other transducers.


14.4 Setting Up the Pressure Measurement

To set up the pressure measurement:

1. Plug the pressure cable into the IBP connector.

2. Prepare the flush solution.

3. Flush the system to exhaust all air from the tubing. Ensure that the transducer and stopcocks are free of air bubbles.

WARNING



If air bubbles appear in the tubing system, flush the system with the infusion solution again. Air bubbles may lead to incorrect pressure readings.

4. Connect the pressure line to the patient catheter.

5. Position the transducer so that it is level with the heart, approximately at the level of the midaxillary line.

6. Select the appropriate label.

7. Zero the transducer. After a successful zeroing, turn off the stopcock to the air turn on the stopcock to the patient.

Heparinized fluid bag

Pressure transducer

Valve

Stopcock

Flushing set

Pressure line

Adapter cable for using disposable transducers

Monitor

WARNING



If measuring intracranial pressure (ICP) with a sitting patient, level the transducer with the top of the patient’s ear. Incorrect leveling may give incorrect values.


14.5 Understanding the IBP Display

The IBP measurement is displayed on the monitor as a waveform and numeric pressures. The figure below shows the waveform and numerics for the Art pressure. For different pressures, this display may be slightly different.

6

5

4

3

1. Waveform

1

2

For some pressures, the parameter window may show the mean pressure only. For different pressures, their defaults unit may be different. If the Art and ICP pressures are measured simultaneously, the ICP parameter area will display numeric

CPP, which is obtained by subtracting ICP from the Art mean.

14.6 Changing IBP Settings

14.6.1 Changing a Pressure for Monitoring

To change a pressure for monitoring:

1. Select the pressure you want to change to enter its setup menu. In the menu, there is a figure showing the current

IBP measurement connector.

Label

PA

Description

Pulmonary artery pressure

Label Description

UAP

BAP

Umbilical arterial pressure

Brachial arterial pressure

LAP

RAP

Left atrial pressure

Right atrial pressure

Art

P1 to P4

NOTE

Arterial blood pressure

Non-specific pressure label

UVP

LV

Umbilical venous pressure

Left ventricular pressure



When two pressures are detected having the same label, the monitor automatically changes one pressure label to a currently unused one.


14.6.2 Setting Alarm Properties

Select [Alarm Setup >>] from the parameter setup menu. You can set alarm properties for this parameter in the pop-up menu.

14.6.3 Changing Averaging Time

The IBP value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patient’s blood pressure. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patient’s blood pressure, but the measurement accuracy will be improved. For critically ill patients, selecting shorter averaging time will help understanding the patient’s state.

To set the averaging time, in the parameter setup menu, select [Sensitivity] and then select [High], [Med] or [Low], the corresponding averaging time is about 1 s, 8 s and 12 s respectively.

14.6.4 Setting Up the IBP Wave

In the setup menu for the pressure, you can:

 Select [Sweep] and then select the appropriate setting. The faster the wave sweeps, the wider the wave is.

 Select [Scale] and then select the appropriate setting. If [Auto] is selected, the size of the pressure’s waveform will be adjusted automatically.

 Select [Filter] and then select the desired option.

14.6.5 Setting the Pressure Unit

Select [Unit Setup >>] from the [User Maintenance] menu. In the pop-up menu, select [Press. Unit] and then select

[mmHg] or [kPa]. Select [CVP Unit] and then select [mmHg], [cmH2O] or [kPa].

14.6.6 Enabling PPV Measurement and Setting PPV Source

PPV indicates pulse pressure variation. To enable PPV measurement, set [PPV Measurement] to [On].

You can select PPV source by enabling the PPV measurement.


WARNING



This monitor can calculate PPV from beat-to-beat values of any arterial pulsatile pressure. The circumstances under which the calculation of a PPV value is clinically meaningful, appropriate and reliable must be determined by a physician.



The clinical value of the derived PPV information must be determined by a physician. According to recent scientific literature, the clinical relevance of PPV information is restricted to sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia.



PPV calculation may lead to inaccurate values in the following situations:



at respiration rates below 8 rpm



during ventilation with tidal volumes lower than 8 ml/kg



for patients with acute right ventricular dysfunction (“cor pulmonale”).



The PPV measurement has been validated only for adult patients.

14.7 Overlapping IBP Waveforms

The IBP waveforms can be displayed together. To combine IBP waveforms:

2. Select the [Screen Setup] tab.

3. In Area A, select [IBP Overlap] from the drop-down list, and then select the IBP waves to be overlapped on the left side of the same line.

Area A

4. Select to save the setting and exit the window. The main screen will display the overlapped IBP waves.


Selecting the overlapped IBP waveforms on the main screen opens the [Overlapping Waveform Setup] menu, where you can:

 Set [Left Scale] and [Right Scale] and then set the scales for the overlapped waveforms. The left scale is for Art, LV,

Ao, FAP, BAP, UAP, and the arterial waveforms of P1~P4; the right scale is for CVP, ICP, LAP, RAP, UVP, and the venous waveforms of P1~P4.

 Set [CVP Scale] individually If the cvp waveform is combined and CVP unit is different from IBP unit.

 Set [PA Scale] individually if PA waveform is combined.

 Set [Gridlines] to [On] or [Off] to show gridlines or not in the overlapped waveform area.

 Select [Sweep] and then set the sweep speed for the overlapped waveforms.

 Select [Filter] and then set the filter for the overlapped waveforms.

Note



The CVP scale changes simultaneously with the right scale. The unit of CVP scale is consistent with CVP parameter unit.

14.8 Measuring PAWP (Only Available with the External Display)

Pulmonary Artery Wedge Pressure (PAWP) values, used to assess cardiac function, are affected by fluid status, myocardial contractility, and valve and pulmonary circulation integrity.

Obtain the measurement by introducing a balloon-tipped pulmonary artery flotation catheter into the pulmonary artery.

When the catheter is in one of the smaller pulmonary arteries, the inflated balloon occludes the artery allowing the monitor to record changes in the intrathoracic pressures that occur throughout the respiration cycle.

The pulmonary wedge pressure is the left ventricular end diastolic pressure when the airway pressure and valve function are normal. The most accurate PAWP values are obtained at the end of the respiration cycle when the intrathoracic pressure is fairly constant and the artifact caused by respiration is minimal.

WARNING



PAWP monitoring is not intended for neonatal patients.

NOTE





After entering the PAWP measurement window, the monitor will turn off the PA alarm automatically.



14-8

14.8.1 Preparing to Measure PAWP

To prepare for a PAWP measurement:

1. Connect the catheter and transducer as shown below. Make sure that:



The PA catheter is in place in the patient.



The IBP transducer is properly connected to the IBP connector on the monitor.

Heparinized fluid bag

Monitor

Pressure transducer

Stopcock

PA catheter

Balloon inflation port

Since PAWP is measured on PA, selecting [PA] as the IBP label is recommended.

2. Select the PA parameter window or waveform area to enter its setup menu. Then, select [PAWP] to enter the PAWP measurement window. You can also enter the PAWP measurement window from the P1-P4 parameter window.


14.8.2 Setting Up the PAWP Measurement

To set up the PAWP measurement:

1. Wedge the flotation catheter into the pulmonary artery. Then inflate the balloon and pay attention to the PA waveform changes on the screen.

.2 After obtaining a stable PAWP waveform, press the [Freeze] key to freeze the waveform and deflate the balloon.

3. You can adjust the PAWP scale to an appropriate position by adjusting or beside the [Adjust] button.

Press the [Confirm] key to save one PAWP measurement.

4. If you need to start a new measurement, select [Next Measure].

WARNING



Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement.



If the PAWP is greater than the PA (systolic), deflate the balloon and report the incident in accordance with hospital policy. Because the pulmonary artery could be accidentally ruptured, and the PAWP value derived will not reflect the patient’s hemodynamic state, but will merely reflect the pressure in the catheter or balloon.

14.8.3 Understanding the PAWP Setup Menu

Select [Setup] to enter the [PAWP Setup] menu. In this menu, you can:



Select an ECG lead wave as the first reference wave.



Select a respiration wave as the second reference wave.

 Select a sweep speed for the displayed waveform.

 Change the size of the PA waveform by adjusting the scale height.




CAUTION




Symptoms

Damped invasive waveform

Possible Cause

Air bubbles in tubing

IBP not displayed/no IBP waveform

Dashes “- -” display in place of numerics.

Abnormally high or low readings

Kinked catheter

Blood in tubing

Improper setup

Cable not plugged in

Transducer not connected.

Stopcock turned improperly.

Transducer not zeroed

The measured result is invalid or out of range.

IBP might be set to non-pulsatile labels like

CVP, LA, RA, and ICP.

Transducer too High or too Low.


Eliminate air from tubing as described in section 14.4 Setting Up the Pressure

Measurement.

Change the position of catheter.

Pressurize the solution bag to 300 mmHg. For details, refer to the instructions for use of the solution bag.

Check display setup in monitor setup.

Check that the cables are properly connected.

Check that the transducer is properly connected.

Check that the stopcock is turned to the correct position.

Check and zero the transducer as described in section 14.3 Zeroing the Transducer.

Change to a pulsatile label.

Unable to Zero

PAWP button disabled

Stopcock not open to atmosphere.

One IBP channel must be labeled PA

Adjust the position of the transducer and make sure that it is level with the heart, approximately at the level of the midaxillary line.

Zero the transducer as described in section

14.3 Zeroing the Transducer.

Check the transducer and make sure the stopcock is turned to the air.

Label an IBP channel as PA. (Also Label an IBP channel as P1/P2/P3/P4, it will automatically change to PA)


15

Monitoring CO

2


CO

2 monitoring is a continuous, non-invasive technique for determining the concentration of CO

2

in the patient’s airway by measuring the absorption of infrared (IR) light of specific wavelengths. CO

2 has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO

2.

When a specific band of

IR light passes through respiratory gas samples, some of IR light will be absorbed by the CO

2

molecules. The amount of

IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO

2

is calculated.

Sidestream/Microstream measurement samples expired patient gas at a constant sample flow from the patient’s airway and analyzes it with a CO

2

sensor built into the CO

2

module.

The sidestream and microstream CO

2 measurement can be used, with specified accessories, with intubated and non-intubated adult, pediatric, and neonatal patients. With intubated patients, a sample of the respiratory gas is drawn from the patient's breathing circuit through an airway adapter and a gas sampling line. With non-intubated patients, the gas sample is drawn through a nasal cannula.

The measurement provides:

1. A

2

waveform.

2. End tidal CO

2

value (EtCO

2

): the CO

2

value measured at the end of the expiration phase.

3. Fraction of inspired CO

2

(FiCO

2

): the smallest CO

2

value measured during inspiration.

4. Airway respiration rate (awRR): the number of breaths per minute, calculated from the CO

2

waveform.


15.2 Identifying CO

2

Modules

This monitor uses an external module with the T1 handle to perform CO

2

monitoring. From left to right are sidestream

CO

2 module and microstream CO

2 module.

1

2

1

2

3

4

3

5

1. Setup key to enter the CO

2

setup menu

2. Measure/standby

4. CO

2

watertrap seat

5. Sampling line connector

15.3 Preparing to Measure CO

2

WARNING





Check that the alarm limit settings are appropriate before taking measurement.

Eliminate the exhausted gas before performing the measurement.

NOTE



Perform the measurement in a well-ventilated environment.


15.3.1 Making a Sidestream CO

2

Measurement

Attach the watertrap to the module and then connect the CO

2

components as shown below. The message [CO2 Sensor

Warmup] is displayed. After warm-up is finished, you can perform CO

2

measurements.

Watertrap fixer

Sampling line

Watertrap

CAUTION





Do not apply adult watertrap to the neonate patient. Otherwise, patient injury could result.

The watertrap collects water drops condensed in the sampling line and therefore prevents them from entering the module. To avoid blocking the airway, empty the watertrap container whenever half full.

Dispose of accumulated fluids in accordance with hospital policy or your local regulations.



The watertrap has a filter preventing bacterium, water and secretions from entering the module. After a long-term use, dust or other substances may compromise the performance of the filter or even block the airway. In this case, replace the watertrap. It is recommended to replace the watertrap once a month, or when the watertrap is found leaky, damaged or contaminated.



Performing CO

2

measurements during warm-up may compromise the measurement accuracy.

NOTE



To extend the life of the watertrap and module, disconnect the watertrap and set the CO

2

operating mode to standby when CO

2

monitoring is not required. Refer to section 15.4.11 Entering the Standby Mode.


15.3.2 Making a Microstream CO

2

Measurement

Connect the sampling line to the module and then connect the CO

2

components as shown below. The message [CO2

Sensor Warmup] is displayed. After warm-up, you can perform CO

2

measurements. The message [CO2 Sensor Warmup] is displayed.

Connector for sampling line

Sampling line

15.4 Changing CO

2

Settings

15.4.1 Accessing CO

2

Menus

By selecting the CO

2

parameter window or waveform, you can access the [CO

2

Setup] menu.

15.4.2 Setting the CO

2

Unit

To set the CO

2

unit, select [Main Menu]

→[Maintenance >>]→[User Maintenance >>]→enter the required password

→[Unit Setup >>] from the [User Maintenance] menu. In the [Unit Setup] menu, select [CO

2

Unit] and then select [mmHg], [%] or [kPa].

15.4.3 Setting Up Gas Compensations

WARNING



Make sure to use the appropriate compensations. Inappropriate compensations may cause inaccurate measurement values and result in misdiagnosis.


For the sidestream CO

2

module:

1. Select the CO

2

parameter window to access the [CO2 Setup] menu..

2. According to the actual condition, set the concentration required for the following compensations:



[O2 Compen]



[N2O Compen]



[Des Compen]

For the microstream CO

2

module, gas compensations are not required.

15.4.4 Setting Up Humidity Compensation

Sidestream and microstream CO

2

modules are configured to compensate CO

2

readings for either Body Temperature and

Pressure, Saturated Gas (BTPS), to account for humidity in the patient’s breath, or Ambient Temperature and Pressure,

Dry Gas (ATPD).

P co2

(mmHg)



CO

2

(vol%)



P amb

/100

P

CO2

(mmHg)



CO

2

(vol%)



(P amb



47)/100

Where,

P

CO2

= partial pressure,

vol%

= CO

2

concentration,

P amb

= ambient pressure, and unit is mmHg.

For the sidestream and microstream CO

2

module, you can set the humidity compensation on or off according to the actual condition.

To set the humidity compensation:

1. Select the CO

2

parameter window to access the [CO2 Setup] menu, and then select [BTPS Compen].

2. Select either [On] for BTPS or [Off] for ATPD, depending on which compensation applies.

15.4.5 Setting the Apnea Alarm Delay

To set the apnea alarm delay:

1. Select the CO

2

parameter window to access the [CO2 Setup] menu.

The monitor will alarm if the patient has stopped breathing for longer than the selected apnea time. The [Apnea Delay] setting takes effect simultaneously to the Resp and CO

2

modules.

WARNING



The respiration measurement does not recognize the cause of apneas. It only indicates an alarm if no breath is detected when a pre-adjusted time has elapsed since the last detected breath. Therefore, it cannot be used for diagnostic purpose.


15.4.6 Choosing a Time Interval for Peak-Picking

For microstream CO

2

modules, you can select a time interval for picking the highest CO

2

as the EtCO

2

and the lowest as the FiCO

2

.

To set the time interval:

1. Select the CO

2


[Max Hold] and then select [Single Breath], [10 s], [20 s] or [30 s] (for microstream CO

2

module only).



[Single Breath]: EtCO

2

and FiCO

2

are calculated for every breath.



[10 s], [20 s], or [30 s]: EtCO

2

and FiCO

2

are calculated using 10, 20 or 30 seconds of data.

15.4.7 Setting the Flow Rate


2

module, you can change the sampling rate of respiratory gas in the patient’s airway by setting the flow rate.

To set the flow rate:

1. Select the CO

2


2. Select an appropriate setting from [Flow Rate].

WARNING



Please consider the patient’s actual bearing capability and select the appropriate flow rate when setting the flow rate.

15.4.8 Setting Up the CO2 Waveform

Select the CO

2

parameter window to access the [CO2 Setup] menu, in which you can:

 Select [Wave Type] and then select [Draw] or [Fill]:



[Draw]: The CO

2

wave is displayed as a curved line.



[Fill]: The CO

2

wave is displayed as a filled area.

 Select [Sweep] and then select the appropriate setting. The faster the wave sweeps, the wider the wave is.

 Change the size of the CO

2

waveform by adjusting the wave [Scale].

15.4.9 Setting RR Source

To set RR source:

1. Select the CO

2


The [RR Source] setting takes effect simultaneously to the Resp and CO

2

modules. For details, refer to section 9.9 Setting

Respiration Rate (RR) Source.


15.4.10 Barometric Pressure Compensation

Both sidestream and microstream CO

2 modules have the function of automatic barometric pressure compensation (the system automatically measures the barometric pressure which the patient monitor is exposed to).

15.4.11 Entering the Standby Mode

By default, the CO

2

module is in measure mode. To enter or exit the Standby mode manually:

1. Select the CO

2


The Standby mode of the CO

2

module relates to the Standby mode of the monitor as follows:

 If the monitor enters the Standby mode, the CO

2

module will also enter the Standby mode.

 If the monitor exits the Standby mode, the CO

2

module will also exit the Standby mode.

 If the CO

2

module enters or exits the Standby mode, it will not affect the monitor.

When you set the sidestream CO

2

module to the Standby mode, the CO

2

gas sample intake pump automatically sets the sample flow rate to zero. When exiting the Standby mode, the CO

2

module continues to work at the previously set sample flow rate.


2

module, you can set the delay time, after which the CO

2

module will enter the Standby mode if no breath is detected.

For the microstream CO

2

module, you can also set a period of time after which the CO

2

module enters the Standby mode if no breath is detected since the CO

2

module is powered on or the CO

2

module switches to the measuring mode or the automatic Standby time is re-set. To set the standby time, in the [CO

2

Setup] menu, select [Auto Standby] and then select the appropriate setting.



Some adverse effects can influence CO

2

performance.

CAUTION



The following factors may influence the accuracy of measurement:



Leaks or internal venting of sampled gas



Mechanical shock



Cyclic pressure up to 10 kPa (100 cmH

2

O)



Other sources of interference, if any



Measurement accuracy may be affected by the breath rate and I/E ratio as follow:



etCO

2

is within specification for breath rate ≤ 60 bpm and I/E ratio ≤ 1:1;



etCO

2

is within specification for breath rate ≤ 30 bpm and I/E ratio ≤ 2:1.



Measurement accuracy is unspecified for breath rate larger than 60 bpm.

15.6 Leakage test

When the sidestream CO

2

modules need maintenance, the monitor displays the message in the CO

2

waveform window:

[Need maintenance. Enter CO2 setup menu.]. Then:

CO2 >>]

2. Perform leakage test according to the prompt messages on the menu.

15.7 Troubleshooting the Sidestream CO

2

Sampling System

When the sampling system of the sidestream CO

2

module does not work correctly, check to see if the sampling line is kinked. If the sampling line is not kinked, remove it from the watertrap. If the monitor gives a message indicating the sampling system still does not work correctly, it indicates that the watertrap is blocked and it should be replaced with a new one. Otherwise, the sampling line is blocked and should be replaced with a new one.


15.8 Removing Exhaust Gases from the System

WARNING



Anesthetics: When using the Sidestream or Microstream CO

2

measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, or to the anesthesia machine/ventilator, to avoid exposing medical staff to anesthetics.

To remove the sample gas to a scavenging system, connect an exhaust tube to the gas outlet connector of the module.

15.9 Zeroing the Sensor

Zero calibration eliminates the effect of baseline drift during CO

2 measurement exerted on the readings and therefore maintains the accuracy of the CO

2

measurements.

For sidestream and microstream CO

2

modules, a zero calibration is carried out automatically when necessary. You can also start a manual zero calibration if necessary.

To manually start a zero calibration:

CO2 >>]

Disconnecting the patient airway is not required when performing a zero calibration.

WARNING



Do not rely on the readings during zeroing.

15.10 Calibrating the Sensor

For sidestream or microstream CO

2

modules, a calibration should be performed once every year or when the readings go far beyond the range. For details, refer to chapter 22 User Maintenance.


15.11 Oridion Information

This trademark is registered in Israel, Japan, German and America.

Oridion Patents

The capnography component of this product is covered by one or more of the following US patents: 6,428,483;

6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending.

No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized CO

2

sampling consumables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO

2

sampling consumable.


16

Review

16.1 Accessing Respective Review Windows

To access the review windows: windows.

16.2 Reviewing Graphic Trends

In the [Review] menu, select [Graphic Trends] to access the following window.

1

2

3

4

5

1. Event mark area

5. Cursor

Events are marked with colors in the event mark area. Red represents high level alarm event. Yellow represents medium/low level alarm event. Green represents manual event.


In this review window:

 Select [Trend Group] and you can select a trend group for viewing in the pop-up menu. If [Custom 1] or [Custom 2] is selected, you can further select [Define Trend Group]. Then you can select the parameters for viewing in the popup menu.

 Select [Zoom] to set the time length of review window.

 Select [Waves] to set the number of waves displayed in one page.

 To browse the graphic trends, select

or to move the cursor one page to the left or right to navigate through the graphic trends.

A time indicating your current position displays above the parameter area. Numeric measurement values corresponding to the cursor location change as the cursor is moved. The measurement value that triggered a high level alarm has a red background. The one that triggered a medium/low level alarm has a yellow background.



Select

or beside [Event] to position the cursor to a different event time.

 Select the [Print] button to set and print the graphic trends report with the printer. For how to set the graphic trends report, refer to chapter 18 Printing.

16.3 Reviewing Tabular Trends

In the [Review] menu, select [Tabular Trends] to access the [Tabular Trends] window.

Events are marked with colors in window’s top area. Red represents high level alarm event. Yellow represents medium/low level alarm event. Green represents manual event.




Select [Trend Group] and you can select a trend group for viewing in the pop-up menu. If [Custom 1] or [Custom 2] is selected, you can further select [Define Trend Group]. Then you can select the parameters for viewing in the pop-up menu.

 Select [Interval] to change the resolution of the trend data and then select the appropriate setting:



[5 s] or [30 s]: select to view up to 4 hours of tabular trends at 5- or 30-seconds resolution.



[1 min], [5 min], [10 min], [15 min], [30 min], [1 h], [2 h] or [3 h]: select to view up to 120 hours of tabular trends at your selected resolution.



[NIBP]: select to view the tabular trends when NIBP measurements were acquired.



To browse the tabular trends, you can select

or to scroll left or right to navigate through the trend database. The measurement value that triggered a high level alarm has a red background. The one that triggered a medium/low level alarm has a yellow background.

 Select

or beside [Event] to position the cursor to a different event time.

 Select the [Print] button to set and print the tabular trends report to the printer. For how to set the tabular trends report, refer to chapter18 Printing.


16.4 Reviewing Events

16.4.1 Marking Events

During patient monitoring, some events may affect the patient and change the displayed waveforms or numerics displayed on the monitor. To help analyze these waveforms or numeric changes, you can mark these events.

Select [Main Menu]→[Mark Event >>]. In the pop-up menu, you can select the waves to store after triggering a manual event. You can select [Trigger Manual Event] from the [Mark Event] menu or the [Manual Event] from the [Main Menu] to trigger a manual event and store it at the same time.

When you are reviewing graphic trends, tabular trends or full-disclosure waveforms, the manual event symbol is displayed at the time the event is triggered.

16.4.2 Reviewing Events

The monitor saves the events in real time. You can review these events.

In the [Review] menu, select [Events] to access the following window. You can review the parameter alarm events, arrhythmia alarm events and manual events. When an event occurs, the system stores all the measurement numerics at the event triggering time and related waveforms 4 seconds, 8 seconds or 16 seconds before and after the event triggering time, as per the setting of recording length.

In the [Events] window:

 Select [Event] to view the desired events.

 Select [Level] to view the desired events according to the alarm priority.

After selecting the desired event, you can select [Details] to access the following window. In this window, the waveform area displays the waveforms related to the event, and the parameter area displays the parameter values happened at the event trigger time.

NOTE



Pausing or switching off alarms will not be recorded as events. The time of these operations will not be recorded in the system log.



A total loss of power has no impact on the saved events.



Earlier-recorded events might be overwritten by later ones if it reaches capacity.


16-4

 You can select the

button or the button to navigate through the waveforms.

 You can select the

button or the button beside the [Event] button to switch between events.



You can select the button to go to the next page and select the desired button.

 You can set the desired [Gain] for ECG waveform.

 You can set the desired [Sweep].

 Select the [Events List] button to view the events list.



Select the [Print] button to print the displayed alarm events to the preconnected laser printer.



By selecting the [Beat Annotation] button, you can display or hide beat labels above the first ECG waveform on the screen. The white beat labels indiate how the monitor is classifying beats and may help explain suspected, missed, or false arrhythmia calls.



N = Normal



V = Ventricular Ectopic



S = Supraventricular Premature



P = Paced



L = Learning



? = Insufficient information to classify beats



I = Inoperative (for example, Lead Off)



M = No beat detected

When beat labels are displayed above the ECG waveform, they can be printed via the recorder or a laser printer. If you select [Beat Annotation] in the [Events] tab to display or hide beat labels, these beat labels will also be displayed or hidden in the [Full Disclosure] tab, and vise versa.

CAUTION



Ensure that you have selected the optimal leads with the best waveform amplitude and the highest signal-to-noise ratio. Selecting the optimal leads is important for beat detection, beat classification, and

V-Fib detection.


16.5 Reviewing Waveforms

In the [Review] menu, select [Full Disclosure] to access the following window.

In the [Full Disclosure] window:

 You can select the button to go to the next page and select the desired button.

 To review full-disclosure waveforms, you need to save waveforms first. Select [Save Waves >>] and then select the parameters whose waveforms you want to view.

 Select the [Beat Annotation] button to display or hide beat labels above the first ECG waveform. For more information on the beat annotation function, refer to the section 16.4.2 Reviewing Events.

16.6 Reviewing OxyCRG (Only Available with the External Display)

NOTE




In the [Review] menu, select [OxyCRG] tab to access the following window.


In this window:

 Select [Details] to view the trends, waveform and measurement numerics of selected parameters.

 Select

or beside the [Scroll] button to switch between events.

 Select

or to switch between pages.

 Select the button at the lower right corner of this window to change the parameter events to be displayed.

After selecting the [Details] button, you can access the following window. In this window, the waveform area displays the trends and waveform of the OxyCRG, and the parameter area displays the parameter values at the event trigger time.

A

B

A. Waveform area B. Parameter area

In this window:

 Select [Events List] to switch to the OxyCRG events list.

 Select [Setup] to change the displayed parameters.

 Select

 Select

or

or

beside the [Event] button to adjust the position of the cursor between events.

beside the [Scroll] button to move the cursor one step left or right to navigate through the trends and waveform.

 Select

or to navigate through the parameter trends and waveform.

 Select the [Record] button to print out the currently displayed trends, waveform, and measurement numerics by the recorder.

 Select the [Print] button to print to the independent printer.


17

Calculations (Only Available with the External Display)


The calculation feature is available with your monitor when mounted on the T1 docking station and connected to an external display. The calculated values, which are not directly measured, are computed based on the values you provide.

You can perform the following calculations:

 Dose calculations

 Oxygenation calculations

 Ventilation calculations



Hemodynamic calculations



Renal calculations

To perform a calculation, select [Main Menu] → [Calc >>], or the [Calculations] QuickKey and then select the calculation you want to perform.

WARNING



After the calculation is finished, verify the entered values are correct and the calculated values are appropriate. We assume no responsibility for any consequences caused by wrong entries and improper operations.

NOTE



The calculation feature is independent of other monitoring functions and can be therefore used for patients being monitored by other monitors. Any operation in a calculation window does not affect the patient monitoring by the local monitor.





17.2 Dose Calculations

17.2.1 Performing Calculations

To perform a dose calculation:

2. Select, in turn, [Patient Cat.] and [Drug Name] and then select the appropriate settings. The dose calculation program has a library of commonly used drugs, of which Drug A through Drug E are for those not specified in this library.



Drug A, B, C, D, E



Aminophylline



Dobutamine



Dopamine



Epinephrine



Heparin











Isuprel

Lidocaine

Nipride

NItroglycerin

Pitocin

3. The system gives a set of default values when the above steps are finished. However, these values cannot be used as the calculated values. The user must enter values following the doctor’s instructions, and only then can the calculated values be used

4. Enter the patient’s weight.

5. Enter other values.

6. Verify if the calculated values are correct.

17.2.2 Selecting the Proper Drug Unit

Each drug has its fixed unit or unit series. Among a unit series, one unit may change to another automatically depending on the entered value.

The units for each drug are as follows:



Drug A, B, C, Aminophylline, Dobutamine, Dopamine, Epinephrine, Isuprel, Lidocaine, Nipride and NItroglycerin use the unit series: g, mg and mcg.

 Drug D, Heparin and Pitocin use the unit series: Unit, KU (kilo units) and MU (million units).

 Drug E uses the unit: mEq (milli-equivalents).

You must select the proper drug name (A, B, C, D or E) according to the units when you define a drug not listed in this library.

NOTE



For neonate patients, [Drip Rate] and [Drop Size] are disabled.


17.2.3 Titration Table

To open the titration table, select [Titration Table >>] in the [Dose Calculation] window after the dose calculation is finished.

In the titration table, when you change:

 [Reference]

 [Interval]

 [Dose Type]

The titrated values change accordingly.

You can also: select or , or or beside the vertical scrollbar to view more values.

17.2.4 Drug Calculation Formulas

Abbreviation

Conc.

Dose

Volume

Unit

g/ml, unit/ml or mEq/ml

Dose/hr, Dose/kg/min ml

Amount g, unit, mEq

Duration h

Formula

Amount / Volume

Rate × Conc.

Rate × Duration

Rate × Duration

Amount/Dose

Drip Rate gtt/min INF Rate × Drop Size / 60

17.3 Oxygenation Calculations


To perform an oxygenation calculation:

[Oxygenation >>].

2. Enter values for calculation.

3. Select the [Calculate] button. The system performs a calculation per the current settings and displays the calculated values.



If a calculated value is outside the range, its background will highlight in yellow. You can select [Range] to view its normal range in the unit field.



Invalid values are displayed as [---].


In the [Oxygenation Calculation] window, you can:

 Change the pressure unit, Hb unit and oxygen content unit by selecting [Press. Unit], [Hb Unit] and [OxyCont Unit] and then selecting the appropriate settings. The changes take effect automatically.



Review the previously performed calculations by selecting [Review].

17.3.2 Entered Parameters

Abbreviation Unit Full spelling

FiO

2

PaO

2

PaCO

2

% mmHg mmHg percentage fraction of inspired oxygen partial pressure of oxygen in the arteries partial pressure of carbon dioxide in the arteries

SaO

2

% saturation

PvO

2

SvO

2 mmHg

% partial pressure of oxygen in venous blood venous oxygen saturation

Hb g/L hemoglobin

CaO

2

CvO

2 ml/L venous oxygen content

VO

2

ml/min consumption

Height cm

Weight kg height weight

17.3.3 Calculated Parameters and Formulas

Abbreviation Unit

BSA m 2

VO

2

calc ml/min

Full spelling

body surface area oxygen consumption

Formula

Wt 0.425 × Ht 0.725 × 0.007184

C(a-v)O

2

× C.O.

C(a-v)O

O

2

ER

2 ml/L

% arteriovenous oxygen content difference oxygen extraction ratio

CaO

2

－ CvO

2

100×C(a-v)O

2

/ CaO

2

C.O. × CaO

2

DO

2 ml/min oxygen transport

PAO

2 partial pressure of oxygen in the alveoli

mmHg

AaDO

2

mmHg oxygen PAO

2

－ PaO

2

CcO

2 ml/L capillary oxygen content Hb × 1.34 ＋ 0.031 × PAO

2 venous admixture

FiO

2

/ 100 × (ATMP－47)－PaCO

2

×[ FiO

2

/100

＋ (1－FiO

2

/100) / RQ ]

Qs/Qt %

100× [1.34 × Hb × (1－SaO

2

/100) ＋ 0.031×

(PAO

2

－PaO

2

)] / [1.34 × Hb × (1－SvO

2

/100)

＋ 0.031× (PAO

2

－ PvO

2

)]

C.O. calc L/min calculated cardiac output

VO

2

/ (CaO

2

－ CvO

2

)


17.4 Ventilation Calculations


To perform a ventilation calculation:

2. Enter values for calculation. If the patient monitor is connected to an anesthesia machine or a ventilator, the system automatically loads the supported parameter values to the [Ventilation Calculation] window.








In the [Ventilation Calculation] window, you can:

 Change the pressure unit by selecting [Press. Unit] and then selecting the appropriate setting. Corresponding pressure values shall convert and update automatically.

 Review the previously performed calculations by selecting [Review].

FiO

2


Abbreviation Unit

%

Full spelling

percentage fraction of inspired oxygen

PeCO

2

PaCO

2

PaO

2 mmHg mmHg mmHg partial pressure of mixed expiratory CO

2 partial pressure of carbon dioxide in the arteries partial pressure of oxygen in the arteries




Formula

PAO

AaDO

Pa/FiO a/AO

MV

Vd

2

2

Vd/Vt

2

2 mmHg mmHg

%

L/min ml

% partial pressure of oxygen in the alveoli

mmHg

(ATMP－47) × FiO

2

/100 －PaCO

2

× [FiO

2

/100 ＋ (1－FiO

2

/100) / RQ ]

PAO

2

－ PaO

2

100 × PaO

2

/ FiO

2 oxygenation ratio arterial to alveolar oxygen ratio minute volume

100 × PaO

2

/ PAO

2

(TV × RR) / 1000 volume of physiological dead space

TV × (1 － PeCO

2

/ PaCO

2

) physiologic dead space in percent of tidal volume 100 × Vd/TV

(TV－ Vd) × RR / 1000

17.5 Hemodynamic Calculations


To perform a hemodynamic calculation:

[Hemodynamic >>].




For a patient who is being monitored, [HR], [Art mean], [PA mean] and [CVP] are automatically taken from the currently measured values. If you have just performed C.O. measurements, [C.O.] is the average of multiple thermodilution measurements. [Height] and [Weight] are the patient’s height and weight you have entered. If the monitor does not provide these values, their fields are blank.



For a patient who is not being monitored, confirm the values you have entered.








In the [Hemodynamic Calculation] window, you can review the previously performed calculations by selecting

[Review].




PAWP

RVSW g·m

RVSWI g·m/m

2

EF % mmHg pulmonary artery wedge pressure

Art Mean

PA Mean

Height cm

Weight kg mmHg mmHg artery mean pressure pulmonary artery mean pressure

CVP mmHg central venous pressure

EDV ml end-diastolic height weight



BSA m 2 body surface area

Formula

Wt 0.425 × Ht 0.725 × 0.007184

C.I. L/min/m

2 cardiac index

SV ml

SI ml/m

2 stroke volume stroke index

SVR DS/cm

5 systemic vascular resistance

SVRI DS·m

2

/cm

5 systemic vascular resistance index

PVR DS/cm 5 pulmonary vascular resistance

PVRI DS·m

2

/cm

5 pulmonary vascular resistance index

LCW kg·m

LCWI kg·m/m

2

LVSW g·m

LVSWI g·m/m

2

RCW kg·m

RCWI kg·m/m 2 left cardiac work left cardiac work index left ventricular stroke work left ventricular stroke work index right cardiac work right cardiac work index

C.O. / BSA

C.O. / HR × 1000

SV/ BSA

79.96 × (AP MAP － CVP) / C.O.

SVR × BSA

79.96 × (PAMAP － PAWP) / C.O.

PVR × BSA

0.0136 × APMAP × C.O.

LCW / BSA

0.0136 × APMAP× SV

LVSW / BSA

0.0136 × PAMAP × C.O.

RCW / BSA right ventricular stroke work right ventricular stroke work index ejection fraction

0.0136 × PAMAP × SV

RVSW / BSA

100 × SV / EDV


17.6 Renal Calculations


To perform a renal calculation:









In the [Renal Calculation] window, you can review the previously performed calculations by selecting [Review].



Urine ml/24h urine kgH

2

O plasm kgH

2

O urine

Cr

UCr

BUN

mol/L

mol/L mmol/L

Height cm

Weight kg creatinine urine creatinine blood urea nitrogen height weight




URNaEx mmol/24h urine excretion

URKEx

Na/K mmol/24h

% urine potassium excretion sodium potassium ratio

CNa

Clcr

FENa

Cosm

CH

2

O

U/P osm

BUN/Cr ml/24h ml/min

% ml/min ml/h

None

None* clearance of sodium creatinine clearance rate fractional excretion of sodium osmolar clearance free water clearance urine to plasma osmolality ratio blood urea nitrogen creatinine ratio

U/Cr None urine-serum creatinine ratio

*: BUN/Cr is a ratio under the unit of mol.

Formula

Urine × URNa / 1000

Urine × URK / 1000

100 × URNa / URK

URNa × Urine / SerNa

Ucr × Urine / Cr / (BSA / 1.73) / 1440

100 × (URNa × Cr ) / (SerNa × Ucr)

Uosm × Urine / Posm / 1440

Urine × (1－Uosm / Posm) / 24

Uosm / Posm

1000 × BUN / Cr

Ucr / Cr

17.7 Understanding the Review Window

With the review feature, you can review oxygenation, ventilation, hemodynamic and renal calculations. The review window for each calculation is similar. Take the hemodynamic calculations review window for example, you can access it by selecting [Review] in the [Hemodynamic Calculation] window.


 You can select

, or to view more values.

 The values that exceed the range are displayed in a yellow background. The [Unit] field displays parameter units. If some parameter values are outside of their normal ranges, you can view their normal range in the [Unit] field by selecting [Range].

 You can review an individual calculation by selecting its corresponding column and then selecting [Original Calc].

You can record the currently displayed calculations or perform another calculation is this window.


FOR YOUR NOTES


18

Printing

18.1 Printer

The monitor can output patient reports via a connected printer. The monitor supports the following printers:

 HP LaserJet 1505n

 HP LaserJet P2035n

 HP LaserJet P4015n

 HP LaserJet Pro 400 M401n

 HP LaserJet 600 M602

 HP LaserJet Enterprise M605

The reports specifications are:

 Paper: A4, Letter

 Resolution: 300 dpi

For more details about the printer, see the document accompanying the printer. With product upgrades, the monitor may support more printers without prior notice. If you have any questions or doubt about your printer, contact Mindray.

18.2 Connecting a printer

To print the reports or the trend data of a patient, you can connect the T1 to a printer via the T1 docking station through the network.

18.3 Setting the Printer

To set the printer’s properties, select [Main Menu]→[Print Setup >>]→[Printer Setup >>]. In the [Printer Setup] menu, you can:

 Select a connected printer

NOTE



If [Panorama] is selected in [Factory Maintenance], the [Central Station] option appears in the [Printer] drop-down list automatically. Select the option, and then you can print real-time waveforms, graphic and tabular trends displaying on the screen of Panorama Central Station for the patient.


 Search for a printer

If your selected printer is not in the list or a new printer is added into the network, you can select the [Search

Printer] to search for all printers in the network.

 Set up the paper size

18.4 Starting Report Printouts

Reports

ECG reports

Tabular trends

Graphic trends

Contents

ECG waveforms and relevant parameter values

Arrh. events ECG waveforms and relevant parameter values

Parameter alarm review

Realtime waves

Depends on the selected parameter group, resolution and time period

Depends on the selected parameter group, resolution and time period

Depends on the selected alarms

Depends on the selected waveforms

Procedures

Select [Main Menu → ] [ECG

Reports >> → [Print]

Select [Main Menu → ] [Tabular Trends

Reports >> →

Menu →

→[Print]

[Print], or select [Main

[Review >> →

Select [Main Menu →

Select [Main Menu →

[Tabular Trends →

Reports >>]→[Print], or select [Main

]

] [Print]

[Graphic Trends

Menu → [Review >> → [Graphic Trends → ] [Print]

Select [Main Menu → ] [Events] →[Arrh. Events]

Select [Main Menu → ] [Realtime

Reports >> → [Print]

] [Parameters]

18.5 Stopping Report Printouts

To stop report printouts, select [Main Menu]→[Print Setup >>]→[Stop All Reports].

18.6 Setting Up Reports

18.6.1 Setting Up ECG Reports

You can print ECG reports only from the 7-lead or12-lead full screen. To set up ECG reports, select [Main Menu]→[Print

Setup >>]→[ECG Reports >>].

 [Amplitude]: set the amplitude of the ECG waveforms.

 [Sweep]: set the wave print speed to 25 mm/s or 50 mm/s.

 [Auto Interval]: if [Auto Interval] is set to [On], the system will automatically adjust the space between waveforms to avoid overlapping.

 [Gridlines]: choose whether to show gridlines.


18.6.2 Setting Up Tabular Trends Reports

To set up tabular trends reports, select [Main Menu]→[Print Setup >>]→[Tabular Trends Reports >>].

 [Start time]: set a time period whose trend data will be printed out by setting [From] and [Back]. For example, if you set [From] as 2014-4-2 10:00:00 and [Back] as [2 h], the outputted data will be from 2014-4-2 08:00:00 to

2014-4-2 10:00:00. In addition, the [Back] can be set to either:



[Auto]: if [Report Layout] is set to [Time Oriented], the report will be printed by time. If [Report Layout] is set to [Parameter Oriented], the report will be printed by parameter.



[All]: if you select [All], all trend data will be printed out. In this case, there is no need to set [From].

 [Interval]: choose the resolution of the tabular trends printed on the report.

 [Report Layout]: if you select [Time Oriented], the report will be printed by time. If you select [Parameter

Oriented], the report will be printed by parameter.

 [Select Parameter >>]: from the pop-up menu, you can:



[Currently Displayed Trended Parameters]: print the parameter trend data selected from the [Tabular

Trends].



[Standard Parameter Group]: select the standard parameter group for printing.



[Custom]: define a parameter group for printing from the parameters displayed in the lower part of the menu.

18.6.3 Setting Up Graphic Trends Reports

To set up graphic trends reports, select [Main Menu]→[Print Setup >>]→[Graphic Trends Reports >>]. Setting up graphic trends reports is similar with tabular trends reports. Refer to section 18.6.2 Setting Up Tabular Trends Reports for details.

18.6.4 Setting Up Realtime Reports

To set up realtime reports, select [Main Menu]→[Print Setup >>]→[Realtime Reports >>].

 [Sweep]: set the wave print speed to 12.5 mm/s, 25 mm/s, 50 mm/s, or Auto.

 [Select Wave >>]: from the pop-up menu, you can:



[Current]: print the currently displayed waves.



[Select Wave]: select the desired waves for printing.

18.7 End Case Reports

ECG reports, tabular trends reports, graphic trends reports, NIBP review reports and real time reports can be set as end case reports. When you discharge a patient, the system will automatically print all contents that are set as end case reports.

For example, to set the ECG report as an end case report:

3. Set as described in section 18.6.1 Setting Up ECG Reports.


18.8 Printer Statuses

18.8.1 Printer Out of Paper

When the printer runs out of paper, the printer will not print until the paper is replaced. If there are too many print jobs that are not printed, a printer error may occur. In this case, you need to install paper and then re-send the print request.

Restart the printer if necessary.

To avoid this, ensure that there is enough paper in the printer before sending a print request.

18.8.2 Printer Unavailable

If the monitor prompts that selected printer is not available, check that the printer is switched on, correctly connected, and installed with paper.


19

Other Functions

19.1 Analog Output

The monitor is configured with a multifunction connector for analog output. You can contact your service personnel for more details.

19.2 Exporting the Log

The monitor stores system status information, including failures, abnormity, and technical alarms, into the log. You can export the log to a USB drive.

To export the log:

1. Connect a USB drive to the monitor’s USB connector. See section 2.2.1.4 Bottom View for the proper location of the

USB connector.

19.3 Using the Storage Card

A storage card is used to prevent data loss in case of a sudden power failure. The patient data such as trend data, waveform data, etc., will be automatically saved into the storage card during patient monitoring. In case of a sudden power failure, the patient data can be retrieved from the storage card after the patient monitor restarts.

To browse the data saved in the storage card, follow this procedure:

2. Select a patient whose data you want to view from the [Patient Data List] and then select [Review].

3. Select [Data Review].

Reviewing the patient data history is just like reviewing the current patient’s data, you can refer to the 16 Review for details

NOTE



The oldest data stored in the storage card is automatically deleted when the remaining space is insufficient.


19.4 Transferring Data

You can transfer the patient data saved in the monitor to a PC via a crossover network cable, or within a LAN for data management, review or print.

19.4.1 Data Export System

You must install the data export system (PN: G-6800-30-51205) on the intended PC before performing the data transfer operation. Refer to the document accompanying the data export system installation CD-ROM for installation instructions.

The data export system supports patient management, data review, data format conversion, print, etc. in addition to data transfer. Refer to the help file of the data export system software for more details.

19.4.2 Transferring Data by Different Means

NOTE



Never enter the data transfer mode when the monitor is in normal operation or performs monitoring. You must re-start the monitor to exit the data transfer mode.

Transfer data via a crossover network cable

Before transferring data using a crossover network cable:


2. Connect one end of the crossover network cable to the T1 docking station and the other end to the PC.

3. Set the IP address of the PC. This IP address must be in the same network segment with that of the monitor.

4. Make sure that the data export system is active on the PC.

Then, follow this procedure to transfer data:

3. Input the IP address already set on the PC.

Transfer data within a LAN

Before transferring data within a LAN, do as follows:

1. Connect the patient monitor and the intended PC into the same LAN and acquire the PC’s IP address.

2. Make sure that the data export system is active on the PC.

Follow the same procedure as via a crossover network cable to transfer data.


19.5 Network Setup

CAUTION



Disconnecting from the network may result in loss of transmitted data, including parameter waveforms and measurements, alarm events, trends and patient data, or cause function failure. In case of network disconnection, check the patient and solve the network problem as soon as possible.

19.5.1 Setting the Network Type

The monitor supports both wired and wireless network.

To set the network type:

1.

Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password→select [Ok].

2.

Select [Network Setup >>].

3.

Select [Monitor Network Setup >>].

4.

Set [Network Type] to [LAN] or [WLAN].

19.5.2 Wireless Network Connection

19.5.2.1 Requirements for Wireless Network

A Mindray proprietary wireless network, installed by approved Mindray service personnel, is required to support wireless networking.

This proprietary network will have the following capabilities:

 Support the 802.11a/b/g/n wireless protocol

 Have a channel bandwidth of 20 MHz

 Support WPA-PSK , WPA2-PSK , WPA-Enterprise, or WPA2-Enterprise

 Provide a signal strength at the monitor of no less than -65 dBm





NOTE



Keep network authentication information (e.g, password) safe to protect the network from being accessed by unauthorized users.



The total throughput of all the wireless devices connected to the wireless network should be less than the effective transmitting capability of the wireless network. The throughput capacity of a single T1 monitor is

2.64 Mbps (for DPM CMS) or 0.74 Mbps (for Panorama CMS).

Do not connect non-approved devices to the wireless network.

Co-channel interference (CCI) on the Wi-Fi network should be no greater than -85dBm. Adjacent–channel interference (ACI) on the Wi-Fi network should be no greater than -50dBm.The recommended distance between the patient monitor and other non-Wi-Fi wireless devices, including wireless devices at the frequency of 2.4GHz (e.g.cellular communication devices , microwave ovens, intercoms, cordless phones and electro-surgical units) is no less than 20 cm.


19.5.2.2 Setting the Wireless Network

To set the wireless network:

1. Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password→select [Ok].

2. Select [Network Setup >>].

3. Select [Monitor Network Setup >>].

4. Set [Network Type] to [WLAN].

5. Set the desired [Address Type].



[Manual] : Indicates that the operator will manually enter network settings including IP Address, Subnet Mask,

Gateway.



[DHCP]: Indicates that the monitor will automatically acquire network settings from a DHCP server.

6. Select [WLAN Setup >>] to enter the [WLAN Setup] menu.

7. Enter a network name (SSID).

8. Select a security mode from the [Security] drop-down list and configure the items.



[WEP_OFF], [WPA-PSK], [WPA2-PSK]: When you select one of these security modes, you need to enter a password for the wireless network.



[WEP_ON] : When you select this security mode, you need to configure [Password], [Key Index], and[AUT.

Type].



[WPA_TKIP], [WPA2_AES], [CCKM_TKIP], [CCKM_AES], [WPA_PSK_AES], [WPA_AES]: These security modes are Wi-Fi Protected Access (WPA/WPA2) enterprise encryption modes. When you select one of these security modes, you need to configure additional items such as [EAP Method], [AUT. Protocol], [Identity],

[Anonymity], and [CA Certificate]. You need to import the desired certificate to the monitor before you can select a certificate. For how to manage certificates, see 19.5.3 Certificates Maintenance.

9. Select [Ok].

19.5.2.3 Setting the WLAN Band and Channels

19-4

The monitor supports 2.4 G and 5 G WLAN. To set WLAN band rate and channels:

1. Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password→select [Ok].

2. Select [Network Setup >>].

3. Select [WLAN Setup >>].

4. Set [WLAN Band] to [Auto], [5G], or [2.4G] according to the band you are using. Auto is the default, indicating that the monitor can automatically identify the WLAN band.

5. Select [AUT. Server Type] to set the type of authentication server. The options are ACS and SBR.

6. Select [BG Channel] to set the type of B and G channels. The options are All, Specified, and None. When you select

[Specified], you need to enter the desired channel.

7. Select [A Channel] to set the type of A channel. The options are All, Specified, and None. When you select

[Specified], you need to enter the desired channel.


19.5.3 Certificates Maintenance

WPA)/WPA2 Enterprise can deliver a higher level of security compared with other security encryption modes such as

WPA2 PSK. You need to import the desired certificates to the monitor before implementing WPA/WPA2 Enterprise encryption on your WLAN. If you do not need to use certificates, you can also delete them from the monitor.

19.5.3.1 Importing Certificates

To import certificates to the monitor:

1.

Create a folder named “cert” in the USB drive

2.

.Copy the certificates to the “cert” folder.

3.

Insert the USB drive into the monitor’s USB port.

4.

Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password.→[Network

Setup >>]→[Certificates Maintenance >>]→[Import certificates>>].

5.

Select the desired certificates and then select [Import].

19.5.3.2 Deleting Certificates

To delete certificates from the monitor:

1.

Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password.→[Network

Setup >>]→[Certificates Maintenance >>]→[Delete certificates>>].

2.

Select the certificates you want to delete. If you want to deselect certificates, select [Reset] and reselect the desired items.

3.

Select [Delete]. The certificates selected will be deleted from the monitor and will disappear from the [CA Certifiate] drop-down list.

19.5.4 Setting the Central Stations

You can configure up to 30 central stations (CMS) for your monitor. To set the CMSs:

Setup >>]→[Central Station Setup >>].

2. Set CMS names and corresponding IP addresses.


19.5.4.1 Selecting a CMS

If there is no CMS in the network where your monitor is located, you need to set [Select CMS] to [Off]. Otherwise, the

“???” three question marks will be displayed at the bottom of the screen.

If there is a CMS in the network where your monitor is located, you need to set [Select CMS] to [On]. You can select the desired CMS for the current monitoring.

To select a CMS, select the CMS status area at the bottom of the screen. Then the selected CMS name will display.

19.5.4.2 Clearing the Selected CMS at Startup

You can clear the selected CMS each time the monitor restarts after being powered off for more than 2 minutes.

To clear the selected CMS:

The selected CMS will not be cleared when only one CMS is configured, or the monitor is restarted within 2 minutes.

This function is switched off by default.

19.5.5 Setting the Network Service Quality Level

To set the quality of service (QoS):

1. Select [Main Menu]→[Maintenance>>]→[User Maintenance>>]→enter the required password.→[Network

Setup >>]→[QoS Setup >>].

2. Select the desired value for [Realtime Monitoring]. This sets the service quality of network connection for important realtime network transactions such as parameter measurements, waveforms, and alarms. The value ranges from 0 to 7. The greater the value, the higher priority the network transaction.

3. Select the desired value for [Others]. This sets the service quality of network connection for secondary non-realtime network transactions such as transferring history data from the monitor to the CMS. The value ranges from 0 to7.

The greater the value, the higher priority the network transaction.

19.5.6 Setting the Multicast Parameters

Multicast parameters must be configured before use on a network.

To set the multicast parameters:

Setup >>]→[Multicast Setup >>].


20

Battery

20.1 Overview

This monitor is designed to operate from rechargeable Lithium-ion battery power when an external power supply is not available. It is recommended to always install a fully charged battery in the monitor to ensure normal monitoring in case of accidental power failure. . If the external power supply is interrupted during patient monitoring, the monitor automatically runs from the battery.

On-screen battery symbols indicate the battery status as follows:

Indicates full battery capacity.

Indicates that battery works correctly. The solid portion represents the current charge level.

Indicates that the battery has low power and needs to be charged.

Indicates that the battery is almost depleted and needs to be charged immediately.

Indicates that no battery is installed.

You can also check the battery’s charge status by pressing the battery gauge button at the top of the battery to illuminate the charge indicators. The charge indicators consist of 5 LEDs, each representing 20% of the total power.

Battery gauge button

Charge indicator

Battery connector

The capacity of the battery is limited. When the battery is low, the technical alarm area displays [Low Battery], the alarm lamp flashes, and the monitor produces an alarm sound.

If the battery is depleted, the battery symbol on the screen flashes, the technical alarm area displays [Battery Depleted], the alarm lamp flashes, and the monitor produces alarm sound. Change the battery or connect the external power to the monitor. Otherwise, the monitor will shut down.


20.2 Safety

CAUTION













Keep the battery out of children’s reach.

Use only specified batteries.

Keep the batteries in their original package until you are ready to use them.

Do not expose batteries to liquid.



If the battery shows signs of damage or signs of leakage, replace it immediately. Do not use a faulty monitor battery.



High ambient temperature shortens battery run time.

Extremely high ambient temperature may cause battery overheat protection, resulting the monitor power off.

Do not crush, drop or puncture the battery. Mechanical abuse can lead to internal damage and internal short circuits. If a battery has been dropped or banged against a hard surface, whether damage is externally visible or not, remove the battery from use and dispose of it properly.



The Lithium-ion battery has a service life of two years. Please replace your battery when it reaches the end of its service life. Failure to replace the battery may cause serious damage to your device from battery overheating.

NOTE



Charge the batteries in this monitor.

20.3 Battery Guidelines

Battery life expectancy depends on how frequent and how long it is used. For a properly maintained and stored lithium ion battery, its life expectancy is about 3 years. For more aggressive use models, life expectancy can be less. We recommend replacing lithium ion batteries after 500 full charge/discharge cycles or every 3 years from first use, whichever occurs first.

To get the most out of the battery, observe the following guidelines:

 The battery performance test must be performed every six months, before monitor repairs, or whenever poor battery performance is suspected.

 Condition the batteries regularly to maintain their useful life. For details, refer to 20.6 Conditioning a Battery..

 Remove the battery before the monitor is shipped or will not be used for more than two weeks. Leaving the battery in a monitor that is not in regular use will shorten the life of the battery.


 The shelf life of a lithium Ion battery is about 6 months when the battery is stored with the battery power being

50% of the total power. In 6 months the battery power must be depleted before the Lithium Ion battery is fully charged. Then run the monitor on this fully charged battery .When its battery power becomes 50% of the total power, take out the battery from the monitor and store it.

 Store batteries properly. For details, refer to 20.8 Storing a Battery.

20.4 Installing or Replacing a Battery

To install or replace a battery:

1. Pull the battery door latch rightwards and lift it to open the battery door.

2. Insert the battery into the battery compartment as indicated.

3. Close the battery door.

To replace a battery, remove the battery as per the instructions on the battery door, and then insert a new battery into the battery compartment.

20.5 Charging a Battery

To optimize performance, a fully (or nearly fully) discharged battery should be charged as soon as possible. The batteries can be charged in either of the following methods:

 Install the battery in the T1 monitor and then connect the T1 monitor with the external DC adapter or T1 docking station.

 Install the battery in the T1 monitor and then plug the T1 monitor into a host monitor. The host monitor must be powered on before the T1 monitor can be charged.

 Use a battery charger specified by the equipment manufacturer.

 Plug the T1 monitor to a satellite module rack that is connected to a powered host monitor.

For the two methods, the battery is charged whenever the T1 monitor is connected to an external power supply regardless of whether or not the T1 monitor is currently turned on.


20.6 Conditioning a Battery

The performance of rechargeable batteries may deteriorate over time. If the battery is not conditioned for a prolonged time, its charge indication may not be accurate and you may wrongly evaluate the remaining battery runtime. Keeping the battery continuously fully charged without conditioning will speed up battery aging and shorten its life time. You should condition the batteries every three months, before it is used for the first time, or when its run time becomes noticeably shorter.

A battery conditioning cycle is one uninterrupted charge of the battery, followed by an uninterrupted battery discharge and charge.

NOTE



The battery charge level indicator does not indicate the capacity or operating time of the battery. It only indicates the current battery charge level. The actual battery capacity decreases over time with the use of the battery. For an old battery, its capacity and operating time may not fulfill battery specifications even the battery charge level indicates the battery is in full charge. Please replace the battery if its operating time is significantly lower than the specified time.

To condition a battery:

1. Disconnect the T1 monitor from the patient and stop all monitoring and measuring procedures.

2. Turn off the T1 monitor. Disconnect the T1 monitor from the external power supply if a DC adapter or T1 docking station is connected.

3. Install the battery to be conditioned in the T1 monitor. Connect the external power supply and allow the battery t to charge uninterruptedly for 7 hours.

4. Disconnect the external power supply. Remove the battery from the T1 monitor. Keep the battery in room temperature for two hours.

5. Allow the T1 monitor to run from the battery until the battery is completely depleted and the T1 monitor automatically shuts off.

6. Fully charge the battery again for use or charge it to 40 – 60% for storage.

CAUTION



Do not use the T1 monitor to monitor the patient during battery conditioning.

NOTE



Do not interrupt battery conditioning.

You can also use the specified battery charger to condition a battery.


20.7 Checking Battery Performance

The performance of a rechargeable battery will deteriorate over time. You should check the battery performance every two months or if you doubt the battery may fail.

1. Disconnect the T1 monitor from the patient and stop all monitoring and measuring procedures.

2. Turn off the T1 monitor. Disconnect the T1 monitor from the external power supply if a DC adapter or T1 docking station is connected.

3. Install the battery to be conditioned in the T1 monitor. Connect the external power supply and allow the battery to be charged uninterruptedly until it is fully charged.

4. Disconnect the external power supply. Remove the battery from the T1 monitor. Keep the battery in room temperature for two hours.

5. Record the battery operating time.

The operating time of the batteries reflects their performance directly. If the operating time of a battery is noticeably shorter than that stated in the specifications, discard the batteries or contact your service personnel.

If the battery performance meets the requirement, fully charge the battery again for use or charge it to 40 – 60% for storage.

NOTE



Battery operating time depends on the device configuration and operation. For example, high display brightness or measuring NIBP repeatedly will shorten the battery operating time.

20.8 Storing a Battery

When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, place the batteries in a cool place with a partial charge of 40% to 60% capacity

(3 LEDs illuminated).

Stored batteries should be conditioned every 2 months. Refer to section 20.6 Conditioning a Battery for details.

NOTE



Remove the battery from the equipment if the equipment is not used for a prolonged period of time (for example, several weeks). Otherwise the battery may be over discharged and damaged.



Storing batteries at high temperature for an extended period of time will significantly shorten their life expectancy.



Storing batteries in a cool place will slow the aging process. Ideally the batteries should be stored at 15 °C.

Do not store the batteries in an environment above 60 °C or lower than -20 °C.


20.9 Recycling Batteries

Discard the battery in the following situations:

 The battery has visual signs of damage.

 The battery fails.

 The battery is aged and its runtime significantly less than the specification.

 The battery has been used for more than two years.

Properly dispose of batteries according to local regulations.

WARNING



Do not open batteries, heat above 60 °C, incinerate batteries, or short the battery terminals. They may ignite, explode, leak, or heat up, causing personal injury.


21

Care and Cleaning

In this chapter we only describe cleaning and disinfection of the main unit. To clean or disinfect reusable accessories, refer to instructions for use of corresponding accessories.

CAUTION



Use only Mindray approved cleaners and disinfectants and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods.



We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s Infection Control Officer or

Epidemiologist.



The responsible hospital or institution shall carry out all cleaning and disinfection procedures specified in this chapter.

21.1 General Points

Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these guidelines:

 Always follow the manufacturer’s instructions for each cleaning / disinfecting agent.

 Do not immerse any part of the equipment into liquid.

 Do not pour liquid onto the equipment or accessories.

 Do not allow liquid to enter the case.



Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or acetone-based cleaners).

WARNING



Be sure to turn off the system and disconnect all power cables from the outlets before cleaning the equipment.

CAUTION



If you spill liquid on the equipment or accessories, contact Mindray or your service personnel.

NOTE



To clean or disinfect reusable accessories, refer to the instructions delivered with the accessories.


21.2 Cleaning

Your equipment should be cleaned on a regular basis. Before cleaning the equipment, consult your hospital’s regulations for cleaning the equipment.

The following table lists approved cleaning agents:

Product Name Product Type

Sodium hypochlorite bleach

Hydrogen peroxide

Liquid

Liquid

Isopropanol Liquid

Rely+On

TM

Virkon

Ⓡ

Powder

Ingredients

Sodium hypochlorite 10%

Hydrogen peroxide 3%

Used as 1% solution*

Biocidal active:

Pentapotassium bis

(peroxymonosulphate) bis (sulphate)

(500g/kg)

Contains dipotassium peroxodisulphate.

1-Propanol Liquid

Perform

Ⓡ

Powder Used as 1% solution*

100g contains 45g Pentapotassium bis

(peroxymonosulphate) bis (sulphate).

5 % to 15% anionic surfactants;<5% non-ionic surfactants; <5% soap and phosphonates, perfumes

Note: The “*” symbol indicates a cleaning solution should be prepared according to the concentration directed by the accompanying instructions for use.

To clean your equipment, follow these rules:

1. Shut down the patient monitor and disconnect it from the power line.

2. Clean the display screen using a soft, clean cloth dampened with a cleaning agent.

3. Clean the exterior surface of the equipment using a soft cloth dampened with a cleaning agent.

4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary.

5. Dry your equipment in a ventilated, cool place.


21.3 Disinfecting

Disinfect the monitor as required in your hospital’s servicing schedule. Cleaning equipment before disinfecting is recommended.

The following table lists approved disinfectants:

Product Name Product Type

Sodium hypochlorite bleach Liquid

Isopropanol Liquid

Rely+On

TM

Virkon

Ⓡ

Powder

Ingredients

Sodium hypochlorite 10%

Used as 1% solution*

Biocidal active:

Pentapotassium bis

(peroxymonosulphate) bis (sulphate)

(500g/kg)

Contains dipotassium peroxodisulphate.

1-Propanol Liquid

Perform

Ⓡ

Powder Used as 1% solution*

100g contains 45g Pentapotassium bis

(peroxymonosulphate) bis (sulphate).

5 % to 15% anionic surfactants;<5% non-ionic surfactants; <5% soap and phosphonates, perfumes

Note: The “*” symbol indicates a disinfectant should be prepared according to the concentration directed by the accompanying instructions for use.

CAUTION



Never use EtO or formaldehyde for disinfection.

21.4 Sterilization

Sterilization is not recommended for this equipment, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the products, accessories or supplies.


FOR YOUR NOTES


22

User Maintenance

CAUTION











Failure on the part of the responsible individual hospital or institution using this equipment to implement a recommended maintenance schedule may cause undue equipment failure and possible health hazards.



The safety checks or maintenance involving any disassembly of the equipment should be performed by professional servicing personnel. Otherwise, undue equipment failure and possible health hazards could result.

No modification of this equipment is allowed.

Do not open the equipment housings. All servicing and future upgrades must be carried out by the service personnel trained and authorized by Mindray only.

If you discover a problem with any of the equipment, contact your service personnel or Mindray.

The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment.

22.1 General Inspection

A thorough inspection should be performed by qualified service personnel to ensure the reliability before the first use, after the monitor has been used for 12 months, or whenever your monitor is repaired or upgraded.

Follow these guidelines when inspecting the equipment:

 Make sure that the environment and power supply meet the specifications.

 Inspect the equipment and its accessories for mechanical damage.

 Inspect all power cords for damage, and make sure that their insulation is in good condition.

 Make sure that only specified accessories are applied.

 Make sure that the alarm system functions correctly.

 Make sure that the batteries meet the performance specifications.

 Make sure that the monitor is in good working condition.

In case of any damage or abnormity, do not use the monitor. Contact the hospital’s biomedical engineers or your service personnel immediately.


22.2 Maintenance and Testing Schedule

The following maintenance and tests, except for visual inspection, power on test, touchscreen calibration, battery check,

ECG verification, NIBP Leakage test, and CO

2

Leakage test, should be carried out by the service personnel only. Ensure the monitor is safe and the performance tested by qualified service personnel before initial installation, after upgrade, or during regular scheduled maintenance. Contact your service personnel if any maintenance is required. Make sure to clean and disinfect the equipment before any test and maintenance.

CAUTION





Changing the settings in [User Settings >>] and [Factory Maintenance >>] menus may cause data loss.

Service personnel should acquaint themselves with the test tools and make sure that the test tools and cables are applicable.

Check/Maintenance Item Recommended Frequency

Performance Tests

Visual inspection 1. When first installed or reinstalled.

ECG test

Resp performance test

Performance test

Verification

1. If the user suspects that the measurement is incorrect.

2. Following any repairs or replacement of relevant module.

3. Once a year for NIBP and CO

2

tests.

4. Once every two years for other parameter module performance tests.

SpO2 test

NIBP test Pressure check

Leakage test

Temp test

IBP performance test

Sidestream and

Microstream CO2 tests and calibration

Leakage test

Performance test

Calibration

Analog output performance test

Electrical Safety Tests

Electrical safety tests

Other Tests

Power on test

If the user suspects that the analog output does not work well.

At least once every two years

Touchscreen calibration

Battery check Functionality test

Performance test

1. When first installed or reinstalled.

2. Following any maintenance or the replacement of any main unit parts.

1. When the touchscreen appears abnormal.

2. After the touchscreen is replaced.

1. When first installed.

2. Whenever a battery is replaced.

Once a year or if the battery run time reduced significantly.


22.3 Checking Monitor and Module Information

To view the information about system start time, self-test, etc., select [Main Menu]

→ [Maintenance >>] → [Monitor

Information >>]. The information will not be saved after the monitor is shut down.

You can also view the information about the monitor configuration and system software version by selecting [Main

Menu]

→[Maintenance >>]→[Software Version >>].

22.4 ECG Verification

The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude becomes greater or smaller. In that case, you need to verify the ECG module.

To perform ECG verification:

1. Select the ECG parameter window or waveform area→[Filter]→[Diagnostic].

Maintenance >>]→[Calibrate ECG]. A square wave appears on the screen and the message [ECG Calibrating] is displayed.

3. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.

4. After the verification is completed, select [Stop Calibrating ECG].

You can print the square wave and wave scale and then measure the difference between them if necessary. If the difference exceeds 5%, contact your service personnel.

22.5 NIBP Leakage Test

The NIBP leakage test checks the integrity of the system and of the valve. It is required at least once a year or when you doubt the measured NIBP. If the test failed, corresponding prompt messages will be given. If no message is displayed, it means no leakage is detected.

Tools required:

 An adult cuff



Air tubing

 A correct sized cylinder

To perform a leakage test:

1. Set the patient category to [Adu].

2. Connect the cuff to the NIBP connector on the monitor.


3. Wrap the cuff around the cylinder as shown below.

Monitor

Connector for

NIBP cuff

Air tubing

Cylinder

Cuff

[Ok].

After about 20 seconds, the monitor will automatically deflate. This means the test is completed. If the message [NIBP

Pneumatic Leak] is displayed, it indicates that the NIBP airway may have leakages. Check the tubing and connections for leakages. If you determine that the tubing and connections are all correct, perform a leakage test again.

If the problem persists, contact your service personnel.

NOTE



The leakage test is intended for use to simply determine whether there are leakages in the NIBP airway. It is not the same as that specified in the EN 1060-3 standard.

22.6 CO

2

Leakage Test

For sidestream and microstream CO

2 modules, leakage test is needed every year or when you suspect the measurement.

To perform a CO

2

leakage test:

1. Connect the CO

2

module with the patient module.

2. Wait until CO

2

warmup is finished and then use your hand or other objects to completely block the gas inlet of the module or watertrap. The sidestream and microstream CO

2

modules will behave as follows:



Sidestream: The alarm message [CO2 FilterLine Err] is displayed on the screen after certain time. Block the gas inlet for another 30 s. If the alarm message does not disappear, it indicates that the module does not leak.



Microstream: The alarm message [CO2 Purging] is displayed on the screen after certain time. Block the gas inlet for another 30s. If alarm message [CO2 FilterLine Err] is shown, it indicates that the module does not leak.


22.7 Calibrating the Touchscreen

To calibrate the touchscreen:

symbol will appear at different positions of the screen.

2. Select, in turn the middle of the

Completed!] is displayed.

symbol. After the calibration is completed, the message [Screen Calibration

NOTE



You cannot calibrate the touchscreen if it is locked.


FOR YOUR NOTES


23

Accessories

The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the patient monitor. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory.

WARNING



Use accessories specified in this chapter. Using other accessories may cause damage to the monitor or not meet the claimed specifications.



Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

CAUTION



Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.





Use the accessories before the expiry date if their expiry date is indicated.

The disposable accessories shall be disposed of according to hospital's regulations.

NOTE



This manual describes all the accessories that are validated for use. Not all accessories are available in every market.

23.1 ECG Accessories

ECG Electrodes

Model

31499224

2245-50

/

PN

0010-10-12304

9000-10-07469

0681-00-0098-01

/ 0681-00-0098-02

Description

Kendall, Medi Trace 210/10 pcs)

ECG electrode (3M, package of 50)

Radio Opaque, Pre-wired, 3-lead ECG electrodes, AHA,

18" (45.7 cm), 3 pcs/pack, 100 packs/box

Radio Translucent, Pre-wired, 3-lead ECG electrodes,

AHA, 18" (45.7 cm), 3 pcs/pack, 100 packs/box

Applicable patient

Adult

Pediatric

Neonate

Neonate


12-PinTrunk Cables

Model

EV6222

PN

040-000754-00

/

/

EY6316B

EY6305B

EY6316A

EY6305A

EY6310B

/

/

/

/

/

/

EL6303A

EL6301B

/

EV6201

EV6202

EV6203

EV6211

EV6212

EV6206

EV6207

EV6216

0010-30-42719

0010-30-42720

0010-30-42721

0010-30-42723

0010-30-42724

009-005266-00

009-005267-00

009-005268-00

EV6217

/

009-005269-00

040-001416-00

/

ECG Leadwires

009-003652-00

3-Electrode Leadwires

Model PN

EL6305A

EL6301A

0010-30-42896

0010-30-42726

0010-30-42731

0010-30-42734

0012-00-1503-05

0012-00-1503-06

0012-00-1503-14

0012-00-1503-15

0012-00-1514-05

0012-00-1514-06

0012-00-1514-14

0012-00-1514-15

040-000748-01

009-004765-00

009-004766-00

009-004771-00

009-004772-00

009-004777-00

Description

ECG cable, 12-pin, 3-lead, defibrillation-proof, DIN connector

ECG cable,12-pin, 3/5-lead, defibrillation-proof, AHA/IEC

ECG cable,12-pin, 3-lead, defibrillation-proof, AHA/IEC

ECG cable, 12-lead, defibrillation-proof, AHA

ECG cable, 12-pin, 3/5-lead, ESU-proof, AHA/IEC

ECG cable, 12-pin, 3-lead, ESU-proof, AHA/IEC

ECG cable, defibrillation-proof, 3.1 m, T/N series




ECG cable, 12-pin 3/5-lead defibrillation-proof

ECG cable, 12-pin 3/5-lead, ESU-proof

Description

ECG leadwires, 3-lead, AHA, pinch


ECG leadwires, 3-lead, AHA, pinch, long

ECG leadwires, 3-lead, AHA, snap

ECG Leadwires, 3-lead, Snap, 24" (61.0 cm), AAMI


ECG Leadwires, 3-lead, Snap, 24" (61.0 cm), IEC


ECG Leadwires, 3-lead, Pinch, 24" (61.0 cm), AAMI


ECG Leadwires, 3-lead, Pinch, 24" (61.0 cm), IEC


Disp leadwires, 3-L snap, AAMI, 20 pk

3-lead, new telemetry, AHA, snap, 24"


3-lead, new telemetry, AHA, pinch, 24"


3-lead, new telemetry, disposable, AHA, snap, 24"


Neonate, infant

Adult, pediatric

Neonate, infant

Adult

Adult, pediatric

Neonate, infant

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric


Neonate, infant

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric


/

/

/

EY6511B

EY6512B

EY6511A

EY6512A

EY6507B

5-Electrode Leadwires

Model PN

EL6501A

EL6503A

0010-30-42727

0010-30-42729

/

/

/

/

EL6501B

/

/

0010-30-42735

0012-00-1503-02

0012-00-1503-03

0012-00-1503-11

0012-00-1503-12

0012-00-1514-02

0012-00-1514-03

0012-00-1514-11

0012-00-1514-12

040-000746-01

009-004782-00

009-004783-00

009-004786-00

009-004787-00

009-004790-00

23.2 SpO

2

Accessories

Extension Cable

Model Part No.

Description


ECG leadwires, 5-lead, AHA, pinch, long

ECG leadwires, 5-lead, AHA, snap









Disp leadwires, 5-L snap, AAMI, 20 pk





5-lead, new telemetry, disposable, AHA, snap, 24"

Description

/

572A

SpO2 Sensors

115-020768-00

0010-20-42712

8-pin, purple connector, 2.1 m, Masimo

8-pin, 2.5 m, Nellcor

Masimo SpO2 Module

Model

LNCS DCI

LNCS DCIP

PN

0600-00-0126

Description

Reusable SpO2 sensor

0600-00-0127 Reusable SpO2 sensor


Adult

Pediatric

LNCS NeoPt 0600-00-0156

LNCS Neo 0600-00-0157

Disposable SpO2 sensor


LNCS Inf

LNCS Pdtx

LNCS Adtx

0600-00-0158

0600-00-0122

0600-00-0121




Neonate

Adult (> 40 kg)

Neonate (< 3 kg)

Infant

Neonate ( 3 - 20 kg)

Pediatric

Adult



Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric

Adult, pediatric


All

All

Application site

Finger

Finger

Foot

Finger

Foot

Toe

Foot

Finger

Finger

23-3

Wavelength of Masimo SpO2 sensors: red light: 660 nm; infrared light: 940 nm.

The maximum photic output consumption of the sensor is less than 18 mW.

The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians (for example, when photodynamic therapy is performed).

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

23.3 NIBP Accessories

NIBP hose

Model

CM1901

CM1903

Cuffs

Model

CM1500A

Part No.

6200-30-11560

6200-30-09688

Part No.

001B-30-70692

CM1500B

CM1500C

CM1500D

001B-30-70693

001B-30-70694

001B-30-70695

Description

Reusable NIBP hose

Reusable NIBP hose

Description

NIBP cuff, single patient use, size 1, 3.1 to 5.7 cm arm circumference, 20 pcs/box




Reusable cuff, arm, 10 to 19 cm (limb), 9.2 cm (bladder) 0683-15-0001-01

0683-15-0002-01

0683-15-0003-01

0683-15-0004-01

0683-15-0005-01

0683-15-0006-01

0683-15-0007-01

0683-14-0001-01

0683-14-0002-01

0683-14-0003-01

0683-14-0004-01

0683-14-0005-01

0683-14-0006-01

0683-14-0007-01

115-027563-00

115-027564-00

115-027565-00

115-027566-00

115-027567-00

Reusable cuff, arm, 25 to 35 cm (limb), 15.1 cm (bladder)

Reusable cuff, arm, 33 to 47 cm (limb), 18.3 cm (bladder)

Reusable cuff, thigh, 46 to 66 cm (limb), 22.5 cm (bladder)

Long, 25-35 cm (limb circumference), latex free

Long, 33-47 cm (limb circumference), latex free

Disposable cuff, arm, 10 to 19 cm (limb), 7.2 cm (bladder)



Disposable cuff, thigh, 46 to 66 cm (limb), 20.5 cm (bladder)

Long, 25-35cm, quick connect

Long, 33-47cm, quick connect, Box of 10

Disposable bladderless cuff, 10 - 19 cm, 10 pcs/box

Disposable bladderless cuff, 18 – 26 cm, 10 pcs/box





Neonate

Adult, pediatric, infant


Neonate

Neonate

Neonate

Neonate

Child

Adult

Large adult

Adult

Adult

Adult

Child

Adult

Large adult

Adult

Adult

Large Adult

Child

Small adult

Adult

Large adult

Thigh


/

/

Model

/

Part No.

115-027568-00

115-027569-00

115-027713-00

Description

Disposable bladderless long cuff, 24 – 35 cm, 10 pcs/box

Disposable bladderless long cuff, 33 – 47 cm, 10 pcs/box

Reusable bladderless cuff, 10 - 19 cm

/

/

/

/

/

/

115-027715-00

115-027716-00

115-027717-00

115-027718-00

115-027719-00

115-031807-00

Reusable bladderless cuff, 24 – 35 cm



Reusable bladderless long cuff, 24 – 35 cm

Reusable bladderless long cuff, 33 – 47 cm

Starter kit, reusable bladderless cuff

23.4 Temp Accessories

Temp Cable

Model Part No. Description

MR420B 0011-30-37391 extension cable, applicable


Adult

Large adult

Child

Small adult

Adult

Large adult

Thigh

Adult

Large adult

/


All

All

All

Temp Probe

Model

MR411

MR412

MR401B

MR402B

/

/

/

/

MR404B

/

Part No.

0011-30-90446

0011-30-90447

Description

Disposable temperature probe, esophageal

Disposable temperature probe, skin

0011-30-37392

0011-30-37394

Reusable temperature probe, esophageal

Reusable temperature probe, esophageal

0011-30-37395 Reusable temperature probe, skin

0206-03-0112-02 PROBE,D TEMP,ES400-12 (box of 20)

0206-03-0118-02 PROBE,D TEMP,ES400-18 (box of 20)

0206-03-0209-02 PROBE,D TEMP,ER 400-9 (box of 20)

0206-03-0212-02 PROBE,D TEMP,ER400-12 (box of 20)

0206-03-0300-02 PROBE,D TEMP,STS-400 (box of 20)


All

All

Adult

Pediatric, neonate

Pediatric, neonate

Adult

Adult

Adult

Adult

Adult


23.5 IBP Accessories

/

/

/

/

IBP Accessories

Model

IM2202

IM2201

ICP Accessories

Model

/

ICT/B

Part No.

001C-30-70757

001C-30-70759

040-001029-00

0010-20-42795

0010-21-12179

0010-21-43082

Part No.

0010-30-42742

0010-10-12151

23.6 CO

2

Accessories

Sidestream CO2 module

Model

4000

Part No. Description

M02A-10-25937 Nasal CO2 sample cannula

4100

4200

60-15200-00

M02A-10-25938

M02B-10-64509

9200-10-10533

Nasal CO2 sample cannula

Nasal CO2 sample cannula

Sampling line

60-14100-00

/

9000-10-07486

040-001187-00

Description

12-pin IBP cable, BD

12-pin IBP cable, Abbott

IBP extended cable with dual-receptacle

IBP cable adapter (12 pin to 6 pin)

12 Pin IBP Cable for Edwards /

12 Pin IBP Cable for Memscap (SP844 82031 transducer) /

All

/


All

All

Description

12-pin ICP cable, Gaeltec

Disposable ICP transducer, Gaeltec

Airway adapter, straight

Airway adapter, disposable


All

All


Adult

Pediatric

Neonate

Adult, pediatric

Neonate

Adult, pediatric

Neonate

Neonate

Adult

Neonate


23.7 Mount and Mounting Accessories

Part No.

045-000924-00

045-000934-00

045-001228-00

045-000931-00

045-001229-00

Description

iPM/iMEC rolling stand with quick release mount

T8 keyboard wall-mount bracket

T1 docking station wall-mount (for LCD)

Wall mount with quick release – M series

LCD wall-mount bracket

115-021237-00

115-023296-00

115-028322-00

Bedrail hook kit

T1 docking station

T1 docking station, without VGA connector

23.8 Miscellaneous Accessories

/

/

/

Part No.

022-000185-00

115-028319-00

115-020874-00

0992-00-0091-07

023-001139-00

023-000217-00

023-000218-00

6800-30-51213

023-000247-00

023-000248-00

023-000524-00

023-000525-00

009-003249-00

009-002944-00

009-003591-00

009-003592-00

023-001128-00

Description

Lithium battery, 7.4V 2500mA

Lithium-ion battery charger kit

AC/DC adapter kit (containing a power cord)

HP LaserJet 401n

HP LaserJet 401dn

HP LaserJet 600 M602

HP LaserJet P4015n

HP LaserJet Enterprise M605

USB drive, 4G, USB 2.0 (TRANSCEND)

USB drive, 4G, USB 2.0 (APACER)

Data output package (CD, Cable, User's Guide)

Keyboard, USB connector, black

Mouse, USB connector, black

Wireless keyboard and mouse set

Wired keyboard and mouse set

12-pin sync-defib. cable

Multifunction analog output cable

T1 docking station cable (1m)

T1 docking station cable (4m)

Elo ET1929LM, 19-inch black LCD


FOR YOUR NOTES


A

Product Specifications

A.1 Classifications

Degree of protection against hazards of explosion

The patient monitor is classified, according to IEC60601-1:

Type of protection against electrical shock

Degree of protection against electrical shock

Mode of operation

Degree of protection against harmful ingress of water

Class I, equipment energized from an external and internal electrical power source.

Type BF defibrillation proof for CO

2 monitoring

Type CF defibrillation proof for ECG, RESP, TEMP, SpO

2

, NIBP, IBP

Continuous

Main unit: IPX1 (Protected against vertically falling water drops)

T1 docking station: IPX1 (Protected against vertically falling water drops)

T1 handle: IPX1 (Protected against vertically falling water drops)

Not suitable: Equipment not suitable for use in the presence of a flammable anesthetic gas mixture.

A.2 Environmental Specifications

CAUTION



The equipment may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges.

Main unit

Item

Temperature (°C)

Relative humidity (noncondensing)

Barometric (kPa)

Microstream CO

2

module

Item

Temperature (°C)


Barometric (mmHg)

Sidestream CO

2

module

Item

Temperature (°C)


Barometric (mmHg)

Operating conditions

0 to 40

15% to 95%

57.0 to 107.4


0 to 40

15% to 95%

57.3 to 105.3


5 to 40

15% to 95%

57.3 to 105.3

Storage conditions

-30 to 70

10% to 95%

16.0 to 107.4


-20 to 60

10% to 95%

57.3 to 105.3


-20 to 60

10% to 95%

57.3 to 105.3

T1 Patient Monitor Operator’s Manual A-1

T1 handle, T1 docking station

Item

Temperature (°C)


Barometric (mmHg)

NOTE




0 to 40

15% to 95%

57.0 to 107.4


-20 to 60

10% to 95%

16.0 to 107.4

The environmental specifications of unspecified parameters are the same as those of the main unit.

A.3 Power Supply Specifications

External DC power supply

12 VDC (±10%)

2 A

Input voltage

Input current

DC adapter

Input

Output

T1 docking station

Input voltage

Input current

Frequency

Battery

Battery Type

100 to 240 VAC (±10%), 50/60 Hz (±3 Hz)

12 VDC, minimum 2 A

100 to 240 VAC (±10%)

0.65 A to 0.35 A

50/60 Hz (±3 Hz)

Rechargeable li-ion battery pack

Charge time

Run time

Shutdown delay

Charge battery with the patient monitor:

Less than 3 hours to 90% and less than 4 hours to 100% with equipment power off;

Less than 12 hours to 90% and less than 14 hours to 100% with equipment power on.

4 h when powered by a new fully-charged battery at 25°C with ECG and SpO

2

cable connected, and auto NIBP measurements at an interval of 15 minutes. Battery run time varies as per system configuration and settings. at least 20 minutes (after a low battery alarm first occurs)

A-2 T1 Patient Monitor Operator’s Manual

A.4 Physical Specifications

Size

Patient monitor (with battery) 143 mm×77 mm×102 mm (5.6 inch×3.0 inch×4.0 inch)

Battery

T1 handle

T1 docking station

Sidestream CO

2

module

Microstream CO

2

module

74 mm×47 mm×24 mm (2.9 inch×1.8 inch×0.9 inch)



136.5×80.5×102 mm (5.4 inch×3.2 inch×4.0 inch)

136.5×40×102 mm (5.4 inch×1.6 inch×4.0 inch)

A.5 Hardware Specifications

A.5.1 Display

T1 display

Screen type

Screen Size

Resolution

External display

Screen type

Screen Size

Resolution

A.5.2 Equipment connector

Main unit

Color TFT LCD

5 inch

480×272 pixels

Color TFT LCD

19 inch

800×600 pixels

1

1

1

Main unit multi-pin connector

Multifunctional connector

DC input

T1 handle

T1 handle multi-pin connector 1

T1 handle multi-pin connector 2


1

1

Network connector

Equipotential grounding terminal

AC power input

VGA connector

1 (RJ45)

1

1 (Standard 3-pin power connector)

1 (Standard)

External device connector

USB connector:

T1 docking station multi-pin connector 1

1

2 (Standard)


Weight

0.93 kg (2.0 pound)

0.12 kg (0.3 pound)

0.6 kg (1.3 pound)

0.89 kg (1.9 pound)

<0.48 kg (1.0 pound)

<0.37 kg (0.8 pound)

A-3

A.5.3 LEDs

Main unit

Alarm lamp

Power on LED

External power LED

Battery LED


Connection status indicator

External power supply indicator

A.5.4 Audio Indicator

Speaker

A.5.5 Outputs

Analog Output

Standard

ECG Analog Output

Bandwidth

(-3dB; reference frequency: 10Hz)

QRS delay

Sensitivity

PACE rejection/enhancement

IBP Analog Output

Bandwidth

(-3dB; reference frequency:1Hz)

Max transmission delay

Defib Sync Pulse

Output impedance

Max time delay

Amplitude

Pulse width

Rising and falling time

A-4

1 (two colors: yellow and red)

1 (green)

1 (green)

1 (green)

1 (green)

1 (green)

Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation; alarm tones comply with IEC60601-1-8.

Meets the requirements of IEC60601-1 for short-circuit protection and leakage current

Diagnostic mode:

Monitor mode:

Surgical mode:

ST mode:

0.05 to 150 Hz

0.5 to 40 Hz

1 to 20 Hz

0.05 to 40 Hz

≤ 25 ms (in diagnostic mode, and non-paced)

1V/mV ±5%

Pace enhancement

Signal amplitude: Voh≥2.5 V

Pulse width: 10 ms±5%

Signal rising and falling time: ≤100 μs

DC to 40 Hz

≤ 30 ms

≤ 100 Ω

35 ms (R-wave peak to leading edge of pulse)

High level: 3.5 to 5 V, providing a maximum of 10 mA output current;

Low level: < 0.5 V, receiving a maximum of 5 mA input current.

100 ms ±10%

≤1 ms


Alarm output (RJ45 connector)

Alarm delay time from patient monitor to remote equipment

The alarm delay time is equal to or smaller than 2 s, measured from the time of the patient monitor alarm signal generation to the time of the remote equipment alarm signal generation.

A.6 Data Storage

Trends

Alarm events

OxyCRG events

Arrh. events

NIBP measurements

Full-disclosure waveforms

Trends: 120 hours, at 1 min resolution

Mid-length trends: 4 hours, at 5 s resolution

Minitrends: 1 hour, at 1 s resolution

100 physiological alarms and manual events and related parameter waveforms.

100 OxyCRG events

100 arrhythmia events and relate waveforms and parameters.

1000 sets

48 hours at maximum. The specific storage time depends on which types of waveforms are stored and the number of waveforms stored.

A.7 Wireless Network

Network standard

Modulation mode

Operating frequency

QoS

Channel spacing

Wireless baud rate

IEEE 802.11a/b/g/n

DSSS and OFDM

For 2.4G frequency bands (FCC): 2.4GHz to 2.483GHz (only when Channels 1 to 11 are in use)

For5G frequency bands (FCC): 5.15GHz to 5.35GHz, 5.725GHz to5.82GHz

QoS Supported. Real time monitoring data transmission priority can be configured with a higher priority than other data transmission.

IEEE 802.11a: 20MHz

IEEE 802.11b/g: 5MHz

IEEE 802.11n at 2.4 GHz: 5MHz

IEEE 802.11n at 5 GHz: 20MHz

IEEE 802.11a: 6 to 54 Mbps

IEEE 802.11b: 1to11 Mbps

IEEE 802.11g: 6 to 54 Mbps

IEEE 802.11n (at both 2.4GHz and 5GHz): 6.5 to 72.2 Mbps

Output power

Data security

< 30 dBm (FCC requirement: detection mode – peak power)

< 20 dBm (CE requirement: detection mode – RMS)

Security standards: WPA-PSK, WPA2-PSK, WPA-Enterprise/WPA2-Enterprise

EAP methods: PEAP-MsCHAPv2, PEAP-GTC, PEAP-TLS, EAP-TTLS, EAP-TLS, EAP-FAST,

EAP-LEAP

Encryption modes: TKIP and AES

Roaming Supported

Number of T1 monitors supported by a single AP: ≤ 16. Each T1 monitor can communicate with the central station and connect to two other monitors at the

System capacity same time, and among them, at most two T1 monitors can transmit history data (the

Panorama central station does not transfer the historical data.) when reconnection at the same time. The wireless functions of all T1 monitors are normal at the same


Resistance to wireless interference time.

The wireless functions of the monitor are normal when the following conditions exist simultaneously:

1.

The distance between interfering devices (including wireless devices at the frequency of 2.4GHz such as cellular communication devices, microwave ovens, intercoms, cordless phones and electro-surgical units, excluding Wi-Fi) and the monitor is greater than 20 cm.

2.

Co-channel interference (CCI) on the Wi-Fi network should be no greater than

-85dBm.

3.

Adjacent–channel interference (ACI) on the Wi-Fi network should be no greater than -50dBm.

SQG-MSD45N FCC approval

A.8 Measurement Specifications

The adjustable range for alarm limits is the same as the measurement range for the parameter unless otherwise specified.

A.8.1 ECG

ECG

Standards

Lead set

ECG standard

Display sensitivity

Sweep speed

Bandwidth (-3dB)

Common mode rejection ratio

(with Notch off )

Notch filter

Differential input impedance

Input signal range

Accuracy of signal reproduction

Meet standards of IEC60601-2-27 and IEC60601-2-25

3-lead: I, II, III

5-lead: I, II, III, aVR, aVL, aVF, V

12-lead: I, II, III, aVR, aVL, aVF, V1 to V6

AHA, IEC

1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40 mm/mV (×4)

Accuracy: ±5%

6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s

Accuracy: ±10%

Diagnostic mode: 0.05 to 150 Hz

Monitor mode:

Surgical mode:

ST mode:

Diagnostic mode:

Monitor mode:

Surgical mode:

ST mode:

0.5 to 40 Hz

1 to 20 Hz

0.05 to 40 Hz

>90 dB

>105 dB

>105 dB

>105 dB

50/60 Hz

≥5 MΩ

±8 mV (peak-to-peak value)

Use A and E methods based on IEC 60601-2-25 to determine frequency response.

Electrode offset potential tolerance ±500 mV


Lead-off detection current

Input offset current

Baseline recovery time

Patient leakage current

Measuring electrode: <0.1 μA

Drive electrode: <1 μA

Measuring electrode: ≤0.1 μA

Drive electrode: ≤1 μA

<5 s (after defibrillation)

<10 μA

Calibration signal

1mV (peak-to-peak value)

Accuracy:

±

5

%

ESU protection

Sampling rate

Cut mode: 300 W

Coagulate mode: 100 W

Recovery time: ≤10 s

In compliance with the requirements in clause 202.6.2.101 of IEC60601-2-27

500 samples/s (A/D)

500 samples/s (ECG algorithm)

Accuracy 2.44μV/LSB

Pace Pulse

Pace pulses meeting the following conditions are labeled with a PACE marker:

Amplitude: ±2 to ±700 mV

Pace pulse markers

Width:

Rise time:

0.1 to 2 ms

10 to 100 μs

Pace pulse rejection

When tested in accordance with the IEC60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions.

Amplitude:

Width:

Rise time:

±2 to ±700 mV

0.1 to 2 ms

10 to 100 μs

Pacer pulse detector rejection of fast

ECG signals

HR

2.9 V/s RTI when measured in accordance with IEC60601-2-27 Section 4.1.4.3.

Measurement range

Neonate:

Pediatric:

Adult:

15 to 350 bpm

15 to 350 bpm

15 to 300 bpm

Accuracy

Sensitivity

Minimum QRS detection threshold (for

Advanced ECG algorithm only)

HR averaging method

±1 bpm or ±1%, whichever is greater.

200μV (lead II)

Adult and pediatric: 0.16 – 0.48 mV

Neonate: 0.12 – 0.40 mV

Advanced ECG algorithm Mortara ECG algorithm


In compliance with the requirements in

IEC60601-2-27: Clause 201.7.9.2.9.101 b) 3) of, the following method is used:

If the last 3 consecutive RR intervals are

In compliance with the requirements in

IEC60601-2-27: Clause 201.7.9.2.9.101 b) 3) of, the following method is used:

Heart rate is computed by averaging greater than 1200 ms, the 4 most recent

RR intervals are averaged to compute the most recent 16 RR intervals, unless the HR by averaging the most recent 4 the HR. Otherwise, heart rate is heart beats is less than or equal to 48. maximum and minimum ones from the most recent 12 RR intervals and then averaging them.

The HR value displayed on the monitor screen is updated every second. screen is updated every second.

Response to irregular rhythm

Response time to heart rate change

Time to alarm for tachycardia

Tall T-wave rejection capability

In compliance with the requirements in IEC60601-2-27: Clause 201.7.9.2.9.101 b)

4) , the heart rate after 20 seconds of stabilization is displayed as follows:

Ventricular bigeminy (3a):

Slow alternating ventricular bigeminy (3b):

Rapid alternating ventricular bigeminy (3c):

Bidirectional systoles (3d):

80±1 bpm

60±1 bpm

120±1 bpm

90±2 bpm

Meets the requirements of IEC60601-2-27: Clause 201.7.9.2.9.101 b) 5).

From 80 to 120 bpm: less than 11 s

From 80 to 40 bpm: less than 11 s

Meets the requirements of IEC60601-2-27: Clause 201.7.9.2.9.101 b) 6).

Waveform

4ah - range:

4a - range:

4ad - range:

4bh - range:

4b - range:

4bd - range:

< 11 s

< 11 s

< 11 s

< 11 s

< 11 s

< 11 s

When the test is performed based on IEC60601-2-27: Clause 201.12.1.101.17, the maximum T-wave amplitude that can be rejected is 1.2mV.

Arrhythmia alarms

Advanced ECG algorithm Mortara ECG algorithm

Asystole, VFib/VTac, Vtac, Vent. Brady,

Extreme Tachy, Extreme Brady, PVC,

Couplet, Bigeminy, Trigeminy, R on T,

Run PVCs, PVCs, Tachy, Brady, Missed

Beats, Vent. Rhythm, Pacer Not Pacing,

Pacer Not Capture, Multif. PVC, Nonsus.

Vtac, Pause, Irr. Rhythm, Afib

Asystole, Vfib, Vtac, Vent. Rhythm,

Couplet, Run PVCs, Bigeminy,

Trigeminy, R on T, Multif. PVC, Irr.

Rhythm, Tachy, Brady, Missed Beats, ,

Pacer Not Pacing, Pacer Not Capture

ST Segment Analysis


Measurement range

Accuracy

Refreshing rate

QT/QTc Interval Monitoring

Measurement range

Accuracy

Resolution

HR alarm limit

HR High

HR Low

ST High

ST Low

QT/QTc alarm limit

QTc High

ΔQTc High

A.8.2 Resp

Lead

Respiration excitation waveform

Baseline impedance range

Bandwidth

Sweep speed

Respiration Rate

Measurement range

-2.0 to +2.0 mV RTI

-0.8 to +0.8 mV:

Beyond this range:

±0.02 mV or ±10%, whichever is greater

Not specified

Per 16 heartbeats (Mortara ECG algorithm), or 10 s (Advanced ECG algorithm)


QT: 200 – 800 ms

QTc: 200 – 800 ms

QT-HR: 15 – 150 bpm for adult, 15 – 180 bpm for pediatric and neonate

QT: ± 30 ms

QT: 4 ms

QTc: 1 ms

Range (bpm)


Not supported

Step

1 bpm (low limit + 2) to 300 bpm

15 to (high limit – 2) bpm

(low limit +0.2) to 2.0 mV

-2.0 to (high limit – 0.2) mV

Range (bpm)

200 – 800 ms

30 – 200 ms

0.1 mV

Step (ms)

10

Options are lead I and II. The default is lead II.

<300 μA RMS, 62.8 kHz (±10%)

200 to 2500 Ω (using an ECG cable with 1kΩ resistance)

0.2 to 2.5 Hz (-3 dB)

3 mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s, or 50 mm/s

Accuracy: ±10%

Adult:

Pediatric, neonate:

0 to 120 rpm

0 to 150 rpm

Accuracy

Apnea alarm time

Alarm limit

RR High

RR Low


7 to 150 rpm:

0 to 6 rpm:

±2 rpm or ±2%, whichever is greater

Not specified

10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s

Range (rpm)

Adult, pediatric:

Neonate:

(low limit + 2) to 100


Step (rpm)

1

0 to (high limit – 2)

A-9

A.8.3 SpO

2

Alarm limit

SpO2 High

SpO2 Low

Range (%)


Masimo: Desat to (high limit – 2)

Nellcor: Desat or 20 (whichever is greater) to (high limit – 2)

0 to (high limit – 2)

Step (%)

1

Desat

Masimo SpO

2

Module

Standards

Measurement range

Meet standards of ISO9919

1 to 100%

Resolution 1%

Response time ≤ 20 s (PR 75 bpm, average time 8 s, SpO

2

value rises from 60% to 95%)

Accuracy

1

70% to 100%: ±2% (measured without motion in adult/pediatric mode)

70% to 100%: ±3% (measured without motion in neonate mode)

70% to 100%: ±3% (measured with motion)

1% to 69%: Not specified.

Refreshing rate

SpO

2

averaging time

≤ 2 s

2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s

Low perfusion conditions

Pulse amplitude: > 0.02%

Light penetration: > 5%

Low perfusion SpO

2

accuracy

2

±2%

PI measurement range 0.02 to 20%

1 The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO

2

against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin.

The Masimo pulse oximeter with sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of

70% to 100% SpO

2

against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

2 The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.


Nellcor SpO

2

Module

Standards

Measurement range

Meet standards of ISO9919

0 to 100%

Resolution 1%

Response time ≤ 30 s (PI > 0.3, no disturbance, SpO

2

value sudden change within 70% - 100%)

Accuracy

70% to 100%: ±2% (adult/pediatric)

70% to 100%: ±3% (neonate)

0 to 69%: Not specified.

≤ 2 s Refreshing rate

*: When the SpO

2 sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood.

Information of the Test Subjects of the Clinical Study Report:

Age (years)

28.2±9.19

Health

Healthy

Skin color Gender Number

Black Male 1

Female 1

Yellow Male 3

Female 9

A.8.4 PR

Alarm limit Range (bpm)

PR High (low limit +2) to 300

PR Low

PR from Masimo SpO

2

Module

15 to (high limit-2)

Step (bpm)

1

Measurement range 25 to 240 bpm

Response time

Accuracy

Refreshing rate

Low perfusion conditions

Low perfusion PR accuracy

PR from Nellcor SpO

2

Module

Measurement range

≤ 30 s (PI > 0.3, no disturbance, PR value sudden change within 25 – 240 bpm)

±3 bpm (measured without motion)

±5 bpm (measured with motion)

1 s

Pulse amplitude: >0.02%

Light penetration: >5%

±3 bpm

20 to 300 bpm

Response time

Accuracy

Refreshing rate


≤ 30 s (PI > 0.3, no disturbance, PR value sudden change within 25 – 250 bpm)

20 to 250 bpm: ±3 bpm

251 to 300 bpm, not specified

1 s

A-11

PR from IBP Module

Measurement range

Accuracy

Refreshing rate

PR from NIBP Module

Measurement range

25 to 350 bpm

±1 bpm or ±1%, whichever is greater

1 s

40 to 240 bpm

Accuracy ±3bpm or ±3%, whichever is greater

A.8.5 NIBP

Standards Meet standards of EN60601-2-30/IEC60601-2-30

Technique Oscillometry

Mode of operation

Auto mode repetition intervals

STAT mode cycle time

Max measurement time

Measurement ranges

(mmHg)

Accuracy

Systolic:

Adult

40 to 270

Diastolic: 10 to 210

Mean: 20 to 230

Max mean error:

5 mmHg

Max standard deviation: 8 mmHg

Static pressure measurement range 0mmHg to 300mmHg

Static pressure measurement accuracy ±3mmHg

Resolution 1mmHg

Adult: 80 to 280

Initial cuff inflation pressure range

(mmHg)

Pediatric:

Neonate:

80 to 210

60 to 140

Default initial cuff inflation pressure

(mmHg)

Software overpressure protection

Hardware overpressure protection

Manual, Auto and STAT

1 min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 8 h, 60, 90, 120, 180, 240 or 480 min

5 min

Adult, pediatric: 180 s

Neonate: 90 s

Pediatric

40 to 200

10 to 150

20 to 165

Neonate

40 to 135

10 to 100

20 to 110

Adult:

Pediatric:

Neonate:

Adult:

Pediatric:

Neonate:

Adult:

Pediatric:

Neonate:

160

140

90

297±3 mmHg

240±3 mmHg

147±3 mmHg

≤330 mmHg

≤330 mmHg

≤165 mmHg


Alarm limit

Sys High

Sys Low

Mean High

Mean Low

Dia High

Dia Low

Range (mmHg)

Adult: (low limit+5) to 270

Pediatric: (low limit+5) to 200

Neonate: (low limit+5) to 135










Step (mmHg)

5

*Measurement accuracy verification: In adult and pediatric modes, the blood pressure measurements measured with this device are in compliance with the Standard for Non-invasive sphygmomanometers (ISO 81060-2) in terms of mean error and standard deviation by comparing with intra-arterial or auscultatory measurements (depending on the configuration) in a typical patient population. For auscultatory reference, the 5th Korotkoff sound was used to determine the diastolic pressure.

In neonatal mode, the blood pressure measurements measured with this device are in compliance with the American

National Standard for Non-invasive sphygmomanometers (ISO 81060-2) in terms of mean error and standard deviation by comparing with intra-arterial measurements (depending on the configuration) in a typical patient population.

A.8.6 Temp

Standards Meet standard of iso 80601-2-56

Operating mode

Measurement range

Accuracy

Refreshing rate

Response time

Minimum time for accurate measurement

Minimum time between measurements

Alarm limit

T1/T2 High

T1/T2 Low

TD High

Direct mode

0 to 50 °C (32 to 122 °F)

±0.1 °C (without probe)

1 s

<5 s

Body surface: <100 s

Body cavity: <80 s

Body surface probe: <100 s

Body cavity probe: <80 s

Range

(low limit +1) to 50 °C

0.1 to (high limit -1) °C

0.1 to 50 °C

Step

0.1 °C


A.8.7 IBP

Standards

IBP

Measurement range

Accuracy

Refreshing rate

Pressure transducer

Excitement voltage

Zero adjustment range

Impedance range

Alarm limit

Sys High

Mean High

Dia High

Sys Low

Mean Low

Dia Low

A.8.8 CO

2

Measurement mode

Sidestream CO

2

Module

Standard

CO

2

Measurement range

Accuracy*

Accuracy drift

Sample flowrate

Sample flowrate tolerance

Warm-up time

Meet standard of EN60601-2-34/IEC60601-2-34.

-50 to 300 mmHg

±2% or ±1 mmHg, whichever is greater (without sensor)

1 s

5 VDC, ±2%

±200 mmHg

300 to 3000 Ω

Range (mmHg) Step (mmHg)


1

-50 to (high limit – 2)

Sidestream, microstream

Meet standard of ISO 80601-2-55

0 to 99 mmHg

0 to 40 mmHg:

41 to 76 mmHg:

±2 mmHg

±5% of the reading

77 to 99 mmHg: ±10% of the reading

Meet the requirement for measurement accuracy within 6 hours

Adult: 70 ml/min, 100 ml/min, 120 ml/min, 150 ml/min

Pediatric, neonate: 70 ml/min, 100 ml/min

15% or 15 ml/min, whichever is greater.

60 s (maximum)


Rise time

Gas sampling delay time awRR measurement range awRR measurement precision

Measured with a neonatal watertrap and a 2.5-meter neonatal sampling line, or an adult watertrap and a 2.5-meter adult sampling line:

<400 ms @ 70 ml/min

<330 ms @ 100 ml/min

<300 ms @ 120 ml/min

<240 ms @ 150 ml/min

Measured with a neonatal watertrap and a 2.5-meter neonatal sampling line:

<4 s @ 100 ml/min

<4.5 s @ 70 ml/min

Measured with an adult watertrap and a 2.5-meter adult sampling line:

<4.5 s @ 150 ml/min

< 5 s @ 120 ml/min

<5.5 s @ 100 ml/min

<6.5 s @ 70 ml/min

0 to 120 rpm

±2 rpm

Apnea time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s

Inaccuracy specifications are affected by the breath rate and I:E change. The end-tidal gas reading is within specification for breath rate below 15BPM and I:E ratio smaller than 1:1 relative to the gas readings without breath

Note: The response time is the sum of the rise time and the delay time.

Effect of interference gases on CO

2

measurements

Gas Concentration (%)

N

2

O ≤60

Quantitive effect*

Hal ≤4

Sev ≤5

Iso ≤5

Enf ≤5

±1 mmHg

Des ≤15

*: means an extra error should be added in case of gas interference when CO

2

measurements are performed between

0-40mmHg.

Alarm limit Range Step

EtCO

2

High (mmHg) (low limit + 2) to 99

1 to (high limit - 2) 1 EtCO

2

Low (mmHg)

FiCO

2

High (mmHg) awRR High (rpm) awRR Low (rpm)

1 to 99

Adult, pediatric:

Neonate:

0 to (high limit - 2)



1


Microstream CO

2

Module

Standard

CO

2

Measurement range

Accuracy*

Meet standard of ISO 80601-2-55

0 to 99 mmHg

0 to 38 mmHg:

39 to 99 mmHg:

±2 mmHg

±5% of the reading+0.08% of (the reading-38)

Meet the requirement for measurement accuracy within 6 hours Accuracy drift

* Accuracy applies for respiration rate up to 80 rpm. For respiration rate above 80 rpm, the accuracy is 4 mmHg or ±12% of the reading, whichever is greater, for EtCO

2

exceeding 18 mmHg. For respiration rate above 60 rpm, the above accuracy can be achieved by using the CapnoLine H Set for Infant/Neonatal. In the presence of interfering gases, the above accuracy is maintained to within 4%.

Sample flow rate

Initialization time

50



7.5



15

ml/min

180 s (maximum)

Measured with a FilterLine of standard length:

2.9 s (typical),

Response time

4.5 s (Maximum) awRR measurement range

The response time is the sum of the rise time and the delay time

Rise time: <190 ms (10% to 90%)

Delay time: 2.7 s (typical)

0 to 150 rpm

0 to 70 rpm: ±1 rpm awRR measurement accuracy 71 to 120 rpm:

121 to 150 rpm:

±2 rpm

±3 rpm

10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Apnea alarm time

Accuracy (of the measured CO

2

partial pressure) applies for breath rates of up to 80 bpm. For breath rates above 80 bpm, accuracy complies with EN 864/ISO 9918 (4 mmHg or ±12 % of reading whichever is greater) for EtCO

2

values exceeding 18 mmHg.

Alarm limit Range Step

EtCO

2

High (mmHg) (low limit + 2) to 99

1 EtCO

2

Low (mmHg)

FiCO

2

High (mmHg) awRR High (rpm)


1 to 99

Adult, pediatric:

Neonate:




1 awRR Low (rpm)


B

EMC and Radio Regulatory Compliance

B.1 EMC

The device meets the requirements of IEC 60601-1-2. All the accessories listed in chapter 23 Accessories also meet the requirements of IEC 60601-1-2 when in use with this device.

CAUTION



Using accessories, transducers and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitor.







The monitor or its components should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor or its components should be observed to verify normal operation in the configuration in which it will be used.







The monitor needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.

Other devices may interfere with this monitor even though they meet the requirements of CISPR.

When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.

Portable and mobile communication equipment may affect the performance of this monitor.

Other devices that have RF transmitter or source may affect this monitor (e.g. cell phones, PDAs, and PCs with wireless function).

T1 Patient Monitor Operator’s Manual B-1

Guidance and Declaration - Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emission tests

Radio frequency (RF) emissions

CISPR 11

Compliance

Group 1

RF emissions CISPR 11

RF emissions CISPR 11

Class B

Class A (when in use with the T1 docking station)

Class A

Electromagnetic environment - guidance

The device uses RF energy only for its internal function. Therefore, its

RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The equipment is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

The device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Harmonic emissions

IEC61000-3-2

Voltage Fluctuations/Flicker

Emissions IEC 61000-3-3

Complies

WARNING



This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM] or shielding the location.

B-2 T1 Patient Monitor Operator’s Manual

If the system is operated within the electromagnetic environment listed in Table Guidance and declaration

—

electromagnetic immunity, the system will remain safe and provide the following essential performance,

 Operating mode

 Accuracy

 Function

 Accessories identification

 Data stored

 Alarm

 Detect for connection

Guidance and Declaration - Electromagnetic Immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity test

Electrostatic discharge

(ESD) IEC 61000-4-2

Electrical fast transient/burst IEC

61000-4-4

Surge IEC 61000-4-5

IEC60601 test level

±6 kV contact

±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

Compliance level

±6 kV contact

±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines


Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency

(50/60 HZ) magnetic field IEC 61000-4-8

±1 kV line(s) to line(s)

±2 kV line(s) to earth

<5 % U

T

(>95 % dip in U

T

) for

0.5 cycle

40 % U

T

(60 % dip in U

T

) for 5 cycles

70 % U

T

3 A/m

(30 % dip in U

25 cycles

T

) for

<5 % U

T

(>95 % dip in U

T

) for

5 s

±1 kV line(s) to line(s)

±2 kV line(s) to earth

<5 % U

T

(>95 % dip in U

T

) for

0.5 cycle

40 % U

T

(60 % dip in U

T

) for 5 cycles

70 % U

T

(30 % dip in U

T

) for

25 cycles

<5 % U

T

(>95 % dip in U

T

) for

5 s

3 A/m

Mains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: U

T

is the AC mains voltage prior to application of the test level.


Guidance and Declaration - Electromagnetic Immunity

The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below.

Immunity test IEC60601 test level

Compliance level


Conduced RF

IEC61000-4-6

3 Vrms

150 kHz to 80 MHz

3Vrms

Radiated RF

IEC61000-4-3

3V/m

80MHz to 2.5GHz

3V/m

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.

Recommended separation distances:

d



1 .

2

P

Recommended separation distances:

80 MHz～800 MHz

d



1 .

2

P

800MHz-2.5GHz

d



2 .

3

P

Where,

P

is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and

d

is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a

, should be less than the compliance level in each frequency range b .

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz to 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.

Note 3: The device that intentionally receives RF electromagnetic energy at the exclusion band (2395.825MHz-2487.645MHz) is exempt from the essential performance requirements, but remains safe. a 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 [ME EQUIPMENT or ME SYSTEM] is used exceeds the applicable RF compliance level above, the [ME EQUIPMENT or ME SYSTEM] should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT or

ME SYSTEM]. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than3V/m.


WARNING



The device is configured with a wireless network connector to receive wireless signal. Other devices may interfere with this device even though they meet the requirements of CISPR.

Recommended separation distances between portable and mobile RF communications equipment and the device

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

Separation distance in meters (m) according to frequency of the transmitter

150 kHz ~ 80 MHz

transmitter (W)

d



1 .

2

P

0.01 0.12

80 MHz ~ 800 MHz

d



1 .

2

P

0.12

800 MHz ~ 2.5 GHz

d



2 .

3

P

0.23

0.1 0.38

1 1.20

10 3.80

0.38

1.20

3.80

0.73

2.30

7.30

100 12.00 12.00 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) 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.


B.2 Radio Regulatory Compliance

RF parameters

Type of Radio

Modulation mode

Operating frequency

Channel spacing

Output power

IEEE 802.11b/g/n (2.4G)

DSSS and OFDM

2412-2462MHz

5 MHz

< 30 dBm (Peak Power)

< 20 dBm (Average Power)

Federal Communications Commission (FCC) Statement

IEEE 802.11a/n (5G)

OFDM

5150-5350MHz, 5725-5850MHz

20 MHz

The wireless module has been tested and found to comply with the limits for a class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:



Reorient or relocate the receiving antenna.

 Increase the separation between the equipment and receiver.



Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

 Consult the dealer or an experienced radio/TV technician for help.

CAUTION



Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

B.3 Radio Frequency Radiation Exposure Information

For body worn operation, this equipment has been tested and meets the FCC and CE RF exposure guidelines when used with the accessories supplied or those approved for use with this product. Use of other accessories may not ensure compliance with FCC and CE RF exposure guidelines.


C

Default Configurations

This chapter lists some of the most important factory default settings in configuration management. You cannot change the factory default configuration itself. However, you can make changes to the settings from the factory default configuration and then save the changed configuration as a user configuration.

C.1 Parameters Configuration

C.1.1 ECG

ECG Setup

Item Name

Alm Source

Configurable

In Config Mode

Yes

In Monitor Mode

Yes

Default

HR

Alm Lev

HR/PR High

HR/PR Low

Yes

Yes

Yes

Yes

Yes Yes

Med

Adu: 120

Ped: 160

Neo: 200

Adu: 50

Ped: 75

Neo: 100

QRS Volume

QRS threshold

Lead Set

ECG Display

Notch Filter

Yes

No

Yes

Yes

Yes

General: Monitor

Yes

OR: Surgery

ICU, NICU: Monitor

CCU: Diagnostic

Yes

General, OR: 2

ICU, NICU, CCU: 1

Yes

Yes

0.16 mV

Auto (if auto lead detection is available);

5-lead (if auto lead detection is not

Yes

Yes available)

Normal

Weak

Pacer Reject No Yes Off

Smart Lead Off

Baseline Drift Removal

(12-lead screen only)

Yes Yes

Yes Yes

Waveform Layout (12-lead Yes Yes

On

On

Standard

T1 Patient Monitor Operator’s Manual C-1

Item Name

screen only)

ECG Waveform Area

(12-lead screen only)

Pacemaker Rate (Mortara algorithm only)

ST Analysis

Item Name

ST Analysis

Configurable

In Config Mode

No

In Monitor Mode

Yes

Yes Yes

Configurable

In Config Mode

Yes

In Monitor Mode

Yes

Default

Normal

60

Default

General, OR, ICU, NICU: Off

CCU: On

Alm Lev

ST-X High

ST-X Low

Yes

Yes

Yes

Yes

Yes

Yes

Med

When ST Unit is mV:

When ST Unit is mm:

When ST Unit is mV:

When ST Unit is mm:

0.20

2.0

-0.20

-2.0

ST Yes

X represents I, II, III, aVR, aVL, aVF, or V1 to V6.

QT/QTc Analysis

Yes

Item Name

QT Analysis

QTc Formula

Analysis lead

QTc Alarm

ΔQTc Alarm

QTc Alarm Level

ΔQTc Alarm Level

Configurable

In Config Mode

Yes

Yes

Yes

Yes

Yes

Yes

Yes

QTc Record

ΔQTc Record

Yes

Yes

Arrh. Analysis

Arrhythmia Threshold Settings (Mindray)

Item Name

Configurable

In Config Mode

C-2

In Monitor Mode

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

In Monitor Mode

J + 60 ms

Default

Off

Hodges

All

Off

Off

Med

Med

Off

Off

Default


Arrhythmia Threshold Settings (Mindray)

Item Name Configurable

PVCs High Yes

Asys. Delay

Vtac Rate

Vtac PVC

Multif. PVC’s Window

Yes

Yes

Yes

Yes

Extreme Tachy Yes

Extreme Brady Yes

Vbrd Rate

Vbrd PVCs

Yes

Yes

Pause Time Yes

Arrhythmia Threshold Settings (Mortara)

Configurable

Item Name

In Config Mode

PVCs high Yes

Asys. Delay

Vtac Rate

Vtac PVCs

Multif. PVC’s Window

Yes

Yes

Yes

Yes

In Monitor Mode

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Default

10

5

Yes

Yes

130

6

Yes 15

Adu:

Yes

Ped:

Adu:

Yes

Ped:

Yes

Yes

Adu:

Ped:

Adu:

Ped:

Yes

Yes

40

5

Yes 2

160

180

35

50

120

160

50

75

Default

10

130

6

15

5

Ped: 160

Ped: 75

Arrhythmia Alarm Settings (Mindray)

Item Name

Asystole Alarm

VFib/VTac Alarm

Vtac Alarm

Vent. Brady Alarm

Extreme Tachy Alarm

Configurable

In Config Mode

Yes

Yes

Yes

Yes

Yes

Extreme Brady Alarm Yes

PVCs/min Alarm Yes

R on T Alarm Yes


Default

In Monitor Mode Alarm Switch

Yes On

Yes

Yes

On

On

Yes

Yes

Yes

Yes

Yes

On

On

On High


Med

CCU: On


Med

CCU: On

Alarm Level

High

High

High

High

High

C-3



Run PVCs Alarm Yes

Couplet Alarm Yes

Multif. PVC Alarm

PVC Alarm

Yes

Yes

Bigeminy Alarm Yes

Trigeminy Alarm

Tachy Alarm

Brady Alarm

Pacer Not Pacing Alarm

Pacer Not Capture Alarm

Missed Beats Alarm

Yes

Yes

Yes

Yes

Yes

Yes

Nonsus. Vtac Alarm Yes

Vent. Rhythm Alarm

Pause Alarm

Yes

Yes

Irr. Rhythm Alarm

Afib Alarm

Yes

Yes

Arrhythmia Alarm Settings (Mortara)

Configurable

Item Name

In Config Mode

Asystole Alarm Yes

VFib Alarm

Vtac Alarm

Yes

Yes

PVCs/min Alarm Yes

R on T Alarm

Run PVCs Alarm

Couplet Alarm

Vent. Rhythm Alarm

Yes

Yes

Yes

Yes

Bigeminy Alarm

Trigeminy Alarm

Tachy Alarm

Brady Alarm

Pacer Not Pacing Alarm

Pacer Not Capture Alarm

Missed Beats Alarm

Multif. PVC

C-4

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Default

Off

Off

Low

Message

Off

Off

Med

Message


Med

CCU: On


Med

CCU: On

Off

Off

Off

Med

Med

Message

Off

Off

Message

Message


Med

CCU: On

Off

Off

Med

Low

Off

Off

Message

Message

Yes

Yes

Yes

Yes

Default

In Monitor Mode Alarm Switch

Yes On

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

On

On

Alarm Level

High

High

High


CCU: On

Med


CCU: On

Med

Off

Off


CCU: On

Low

Message

Med


CCU: On

Med


CCU: On

Med

Off

Off

Off

Off

Med

Med

Message

Message

Yes

Yes

Off

Off

Med

Med


Detection Mode

RR Source

C.1.3 PR

Item Name

Alm Lev

HR/PR High

HR/PR Low

PR Source

Alm Source

Beat Vol



Irr. Rhythm Alarm Yes

C.1.2 Resp

Item Name

Configurable

In Config Mode

Alm Lev

RR High

RR Low

Yes

Yes

Yes

Apnea Delay Yes

Yes

Default

Off

Default

In Monitor Mode

Yes

Yes

Med

Adu, Ped:

Neo:

30

100

Yes

Yes

Adu, Ped:

Neo:

Adu, Ped:

Neo:

8

30

20

15

Adu, Ped: Auto

Yes

Neo: II

Message

Yes

No

Yes

Yes

Auto

Auto

Yes

Yes

Yes

Yes

Configurable

In Config Mode

Yes

Yes

Yes

Yes

Yes

Yes

In Monitor Mode

Yes

Yes

Default

Med

Adu: 120

Ped: 160

Neo: 200

Adu: 50

Ped: 75

Neo: 100

SpO

2

HR

General, OR: 2

ICU, NICU, CCU: 1


C.1.4 SpO

2

Item Name

Alm Lev

SpO

2

High

SpO

2

Low

Sensivity（Mindray）

Sensitivity (Masimo)

Averaging (Masimo)

Sat-Seconds (Nellcor)

PI Zoom (Mindray)

NIBP Simul

C.1.5 Temp

Item Name

Alm Lev

T1/T2 High (ºC)

T1/T2 Low (ºC)

TD High (ºC)

Configurable

In Config Mode

Yes

Yes

In Monitor Mode

Yes

Yes

Yes

Default

SpO

2:

:

Desat:

Med

High

When used with a DPM central station

Adu, Ped: 100

Neo: 95

When used with a Panorama central station

Adu, Ped:

Neo:

90

Off

95

Yes

Yes Yes Med

Yes Yes Normal

Yes

Yes

Yes

Yes

Yes

Yes

8 s

0 s

No

No Yes Off

Configurable

In Config Mode

Yes

Yes

Yes

Yes

In Monitor Mode

Yes

Yes

Yes

Yes

Default

Med

38.0

35.0

2.0

C-6 T1 Patient Monitor Operator’s Manual

C.1.6 NIBP

Item Name

Alm Lev

NIBP End Tone

Initial Pressure (mmHg)

Configurable

In Config Mode

Yes

Yes

Yes

Yes

Default

In Monitor Mode

Yes Med

General: 15 min

OR: 5 min

Yes ICU: 15 min

Yes

NICU: 30 min

CCU: 15 min

Off

Yes

Yes

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

80

60

40

160

140

90

Cuff Press. (mmHg)

Alarm Limit

NIBP-S High (mmHg) Yes Yes

NIBP-S Low (mmHg)

NIBP-M High (mmHg)

NIBP-M Low (mmHg)

NIBP-D High (mmHg)

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

50

40

20

90

70

60

60

50

25

90

70

40

160

120

90

110

90

70

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

NIBP-D Low (mmHg) Yes


C.1.7 IBP

Item Name

Configurable

In Config Mode In Monitor Mode

Default

Alm Lev Yes Yes Med

P1 Measure

P2 Measure

P3 Measure

P4 Measure

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

All

All

Mean

Mean

PPV Measurement

PPV Source

Yes

Yes

Yes

Yes

Off

Auto

Sensitivity Yes Yes Med

Gridlines Yes Yes Off

Art, Ao, UAP, BAP, FAP, LV, P1-P2 Arterial Pressure Alarm Limits

IBP-S High (mmHg) Yes Yes

Adu:

Ped:

Neo:

160

120

90

IBP-S Low (mmHg) Yes Yes

Adu:

Ped:

Neo:

90

70

55

IBP-M High (mmHg) Yes Yes

Adu:

Ped:

Neo:

110

90

70

IBP-M Low (mmHg)

IBP-D High (mmHg)

IBP-D Low (mmHg)

Yes

Yes

Yes

Yes

Yes

Yes

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

Adu:

Ped:

Neo:

90

70

60

70

50

35

50

40

20


PA Alarm Limit

PA-S High (mmHg) Yes Yes

PA-S Low (mmHg)

PA-M High (mmHg)

PA-M Low (mmHg)

PA-D High (mmHg)

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

PA-D Low (mmHg) Yes Yes

CVP, LAP, RAP, ICP, UVP, P3-P4 Venous Pressure Alarm Limits

IBP-M High (mmHg) Yes Yes

IBP-M Low (mmHg) Yes Yes

Art, Ao, BAP, FAP, LV, P1-P2 Arterial Pressure Scale

Scale (mmHg) Yes Yes

PA Waveform Scale

Scale (mmHg) Yes Yes

CVP, LAP, RAP, ICP, UVP Scale

Scale (mmHg) Yes

UAP, P3-P4 Venous Pressure Scale

Scale (mmHg) Yes

IBP Overlapping Left Scale

Scale (mmHg) Yes

IBP Overlapping Right Scale

Scale (mmHg) Yes

Yes

Yes

Yes

Yes

Adu:

Ped, Neo:

Adu:

Ped, Neo:

Adu:

Ped, Neo:

Adu:

Ped, Neo:

Adu:

Ped, Neo:

Adu:

Ped, Neo:

35

60

10

24

20

26

0

12

16

4

0

-4

Adu:

Ped, Neo:

0

10

4

0-160

0-30

0-20

0-80

0-160

0-20


C.1.8 CO

2

Item Name

Alm Lev

Apnea Delay

Operating Mode

Configurable

In Config Mode

Yes

Yes

Yes

In Monitor Mode

Yes

Yes

Yes

Default

Med

Adu, Ped:

Neo:

Measure

20

15

Scale (mmHg)

RR Source

Sidestream CO

2

Setup

Yes

No

Yes

Yes

50

Auto

Flow Rate

BTPS Compen

N

2

O Compen

Yes

Yes

Yes

Yes

Yes

O

2

Compen Yes Yes

Yes

Yes

Yes

Adu,

Ped:

Neo:

Off

0

General: 21

OR: 100

ICU, NICU, CCU: 21

0

120 ml/min

100 ml/min

70 ml/min

Des Compen

Microstream CO

2

Setup

BTPS Compen

Max Hold

Auto Standby (min)

Alarm Limits

Yes

Yes

Yes

Yes

Yes

Yes

Off

20 s

0

EtCO

EtCO

FiCO

2

2

2

High (mmHg)

Low (mmHg)

High (mmHg)

RR High

RR Low

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Adu, Ped:

Neo:

Adu, Ped:

Neo:

Adu, Ped, Neo: 4

50

45

25

30

Adu, Ped:

Neo:

Adu, Ped:

Neo:

30

100

8

30


C.2 Routine Configuration

C.2.1 Alarm

Item Name

Configurable


Default

Alm Volume

Reminder Vol

Recording Length

Apnea Delay

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

General: 2

OR:

ICU, NICU, CCU:

Low

16 s

Adu, Ped:

Neo:

6 s

30 s

2

1

2

20s

15 s

Alarm Delay

ST Alarm Delay

C.2.2 Screens

Yes

Yes

Yes

Yes

Item Name

Configurable


Yes Yes

Default

Choose Screen

Display the ST segments on ECG screen

Yes Yes

Normal Screen

Unselected

Select Wave

Sequence for

Normal Screen

1

Yes Yes

ECG

2 SpO

2

+ PR

3 Resp

4 NIBP

Parameter 1 ECG

Select Parameters for Big Numerics

Screen

Parameter 2

Parameter 3

Parameter 4

Yes Yes

SpO

2

Resp

NIBP

+ PR

C.2.3 Parameter/ Wave Color

Configurable

Item Name

In Config Mode

ECG

In Monitor Mode

Default

NIBP

SpO

2

PR

TEMP

Art/Ao/UAP/FAP

/BAP/LV/P1~P4 (arterial pressure)

CVP/ICP/P1~P4 (venous pressure)

RESP

CO

2

No Yes

Green

White

Cyan

Cyan

White

Red

Blue

Yellow


C.2.4 Night Mode

Item Name

Alm Volume

QRS Volume

Key Volume

Stop NIBP

C.2.5 Outdoor Mode

Item Name

Measurement Color

Configurable

In Config Mode

No

No

No

No

Configurable

In Config Mode

No

In Monitor Mode

Yes

Yes

Yes

Yes

In Monitor Mode

Yes

Default

2

1

0

Unselected

Default

White

Key Volume

Alm Volume

Reminder Tone

QRS Volume

C.2.6 Review

Item Name

No

No

No

No

Yes

Yes

Yes

Yes

5

5

High

5

Configurable


Tabular Trends

Interval No Yes

Trend Group

Trend Group

No

No

Graphic Trends Zoom No

Yes

Yes

Yes

Full Disclosure

Waves No Yes

Save Waves No Yes

Gain No Yes

Sweep No Yes

Default

General: 30 min

OR: 5 min

ICU, NICU, CCU: 30 min

Standard

Standard

2

Save ECG1 by default.


C.2.7 Event

Item Name

Waveform 1

Waveform 2

Configurable

In Config Mode

No

No

No

In Monitor Mode

Yes

Yes

Yes

Default

II

General, OR, ICU, CCU:

NICU

General, OR, ICU, CCU:

NICU

I

Pleth

Pleth

Resp

Waveform 3

C.2.8 Print

Item Name

Paper Size

Print On Both Sides

ECG

Reports Auto Interval

12-Lead Format

Set as End Case Report

Configurable

In Config Mode

No

No

No

No

No

In Monitor Mode

Yes

Yes

Yes mm/s

Yes

Yes

Yes

Default

A4

Off

Off

12 x 1

Unselected

Tabular

Trends

Reports

Resolution No Yes Auto

Report Layout No Yes Parameter Oriented

Currently Displayed Trended

Parameters

Standard Parameter Group

No Yes Selected

No Yes Unselected

Graphic

Trends

Reports

Not Print Blank Pages

Set as End Case Report

Paginal Time

No

No

No

Yes

Yes

Yes

Selected

Unselected

Auto

Set as End Case Report No Yes Unselected

Realtime

Reports

Select Wave No Yes Current

C.2.9 Others

Item Name

Configurable


Default

Brightness No 5

Key Volume No Yes 2


C.3 User Maintenance Items

Item Name

Changing Bed No.

Atmospheric Pressure

Height Unit

Weight Unit

ST Unit

Press. Unit

CVP Unit

CO

2

Unit

Temp Unit

Network Type

Address Type

Select CMS

Latching Alarms

Alarm Pause Time

Configurable

In Config Mode

No

No

No

No

No

No

No

No

No

No

No

No

No

No

In Monitor Mode

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Default

mmHg

°C

LAN

Manual

On

Off

2 min

Protected

760 mmHg cm kg mV mmHg cmH

2

O

Minimum Alarm Volume No

Alarm Sound No

High Alarm Interval (ISO mode) No

Yes

Yes

Yes

General, ICU, NICU, CCU: 2

OR: 1

ISO

10 s

Medium (ISO mode) No

Low Alarm Interval (ISO mode) No

Yes

Yes

20 s

20 s

No Yes Off Reset Other Bed’s Alarms

(external display only)

Alarm Reset By Other Bed No Yes On

Other Bed Disconnection Alarm No

Reminder Interval No

Reminder Tone

ECGLeadOff Lev.

No

No

SpO

2

SensorOff Lev.

IBP SensorOff Lev.

Lethal Arrh. OFF

No

No

No

Extended Arrh.

Alarm Light on Alarm Reset

Alarm Delay

ST Alarm Delay

Wave Line

Outdoor Mode

ECG Standard

Notch Freq.

Data Transfer Method

SpO

2

Tone

No

No

No

No

No

No

No

No

No

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

On

1 min

On

Low

Low

Med

Disable

Enable

On

6 s

30 s

Mediate

Manual

AHA

50 Hz

Off

Mode 1


Item Name

Clear CMS IP at startup

Transferred Data Length

Parameter Switch

Configurable

In Config Mode

Yes

No

Yes

In Monitor Mode

Yes

Yes

Yes

Default

Off

4 h

Selected


FOR YOUR NOTES


D

Alarm Messages

This chapter lists only the most important physiological and technical alarm messages. Some messages appearing on your monitor may not be included.

In this chapter:



The “I” column indicates how indications of technical alarms perform after the alarm system is reset: “A” means that some technical alarms are cleared; “B” indicates that some technical alarms are changed to the prompt messages; and “C” indicates that a “√” appears before the alarm message, appears in the alarm symbol area, and the indication of the alarm lamp depends on the alarm light setting. Refer to section 7.8 Resetting Alarms for details.

 The “L” field indicates the alarm level: “H” means high, “M” means medium and “L” means low. “*” means the alarm level is configurable.

 XX represents a measurement or parameter label or module, such as ECG, NIBP, HR, ST-I, PVCs, RR, SpO

2

, PR, etc.

In the “Cause and Solution” column, corresponding solutions are given instructing you to troubleshoot problems. If the problem persists, contact your service personnel.

D.1 Physiological Alarm Messages

Measurement Alarm messages

XX Too High

L

M*

XX

XX Too Low

ECG Weak Signal

M*

H

Cause and solution

XX value has risen above the high alarm limit or fallen below the low alarm limit. Check the patient’s condition and make sure that the patient category and alarm limit settings are correct.

The ECG signal is too weak for the monitor to perform ECG analysis.

Check the patient’s condition and the ECG connections.

ECG

Asystole

VFib/VTac

Vtac

Vent. Brady

Extreme Tachy

Extreme Brady

R on T

Run PVCs

Couplet

PVC

PVCs/min

Bigeminy

Trigeminy

Tachy

Brady

H

M*

M*

M*

M*

M*

H

H

H

H

H

M*

M*

M*

M*

Arrhythmia has occurred to the patient. Check the patient’s condition and the ECG connections.

T1 Patient Monitor Operator’s Manual D-1

Measurement

Resp

SpO

CO

2

2

Alarm messages

Missed Beats

Afib

Irr. Rhythm

Vent. Rhythm

Multif. PVC

Nonsus. Vtac

Pause

Pacer Not Pacing

Pacer Not Capture

Resp Apnea

Resp Artifact

SpO

2

Desat

No Pulse

CO

2

Apnea

M*

M*

M*

M*

M*

M*

L

M*

M*

M*


The pacer appears abnormal. Check the pacer.

H

H

H

H

H

The respiration signal was too weak for the monitor to perform respiration analysis. Check the patient’s condition and the Resp connections.

The patient’s heartbeat has interfered with his respiration. Check the patient’s condition and the Resp connections.

The SpO2 value has fallen below the desaturation alarm limit. Check the patient’s condition and check if the alarm limit settings are correct.

The pulse signal was too weak for the monitor to perform pulse analysis. Check the patient’s condition, SpO

2 sensor and measurement site.

The patient stops breathing, or the respiration signal was too weak for the monitor to perform respiration analysis. Check the patient’s condition and the RM connections.

D-2 T1 Patient Monitor Operator’s Manual

D.2 Technical Alarm Messages

Measurement

YY

ECG

Resp

Temp

Alarm message

YY SelfTest Err

YY Init Err

YY Init Err N

N is within 1 to 8

YY Comm Err

YY Comm Stop

YY Comm Abnormal

YYLimit Err

YY Overrange

L

H

H

H

H

H

H

L

L

I

C An error occurred to the YY module, or there is a

A

A


problem with the communications between the module and the monitor. Restart the monitor. If the problem persists, contact your service personnel.

A

C

A

C YY parameter alarm limit was accidentally changed.

Contact your service personnel.

C The measured YY value is not within the specified range for YY measurement. Contact your service personnel.

ECG Lead Off

ECG YY Lead Off

L*

L*

B The electrode has become detached from the patient or

B the lead wire has become disconnected from the

Note: YY represents the leadwires V, LL, LA, adapter cable. Check the connections of the electrodes

RA, C, F, L, R, V1, V2, V3, V4, V5, V6, C1, C2, and leadwires.

C3, C4, C5, or C6

ECG Noisy L A The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for great motion.

ECG Artifact

(for Mortara ECG algorithm only)

L A Artifacts are detected on the ECG analysis lead and as a result heart rate cannot be calculated, and Asystole,

Missed Beats and Vfib cannot be analyzed. Check the connections of the electrodes and leadwires and check for any possible source of interference around the cable

ECG High Freq. Noise

ECG Low Freq. Noise

ECG Amplitude Too Small

ECG Config. Err

Resp Disturbed

Temp Cal. Err

T1 Sensor Off

L

L

L

L

L

H

L and electrode. Check the patient’s condition and check the patient for excessive movement.

A High frequency signals are detected on the ECG analysis lead. Check for any possible source of interference around the cable and electrode.

A Low frequency signals are detected on the ECG analysis lead. Check for any possible source of interference around the cable and electrode.

C The ECG amplitude didn’t reach the detected threshold.

Check for any possible source of interference around the cable and electrode.

C ECG configuration was incorrectly downloaded. Check the downloaded configuration and re-download the correct configuration.

A The respiration circuit is disturbed. Restart the monitor.

C Calibration failed. Restart the monitor.

A The Temp sensor has become detached from the patient


Measurement

SpO

2

SpO

NIBP

Alarm message

T2 Sensor Off

Temp Cal. Err

SpO

SpO

SpO

SpO

2

SpO

SpO

SpO

2

2

2

2

2

2

2

Sensor Off

Sensor Fault

No Sensor

Unknown Sensor

Sensor Incompatible

Too Much Light

Low Signal

No Pulse

L

L

H

L*

L

L

L

L

L

L

L

I Cause and solution

A or the module. Check the sensor connections.

C

B The SpO

2

sensor has become detached from the patient

C

B or the module, or there is a fault with the SpO

2

sensor, or an unspecified SpO

2

sensor has been used. Check the

C

C sensor application site and the sensor type, and make sure the sensor is not damaged. Reconnect the sensor or use a new sensor.

C There is too much light on the SpO

2

sensor. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light.

C The SpO

2

signal is too low or too weak. Check the patient’s condition and change the sensor application

C site. If the error persists, replace the sensor.

SpO

SpO

SpO

2

2

2

Interference

Comm Abnormal

Board Fault

NIBP Loose Cuff

NIBP Air Leak

NIBP Pneumatic Leak

NIBP Cuff Type Wrong

NIBP Air Pressure Err

NIBP Weak Signal

NIBP Signal Saturated

L

H

L

L

L

L

L

L

L

L

C The SpO

2

signal has been interfered. Check for any possible sources of signal noise around the sensor and check the patient for excessive movement.

A An error occurred to the SpO

2 measurement module, or there is a problem with the communications between the module and the monitor. Restart the monitor. If the error remains, contact your service personnel.

C There is a problem with the SpO

2

measurement board.

Do not use the module and contact your service personnel.

A The NIBP cuff is not properly connected, or there is a leak

A in the airway.

A Check the NIBP cuff and pump for leakages.

A The cuff type applied mismatches the patient category.

Verify the patient category and replace the cuff.

A An error occurred to the air pressure. Verify that the monitor application site meets the environmental requirements and check if there is any source that affects the air pressure.

A The patient’s pulse is weak or the cuff is loose. Check the patient’s condition and change the cuff application site.

If the error persists, replace the cuff.

A The NIBP signal is saturated due to excess motion or other sources.

NIBP Overrange

NIBP-YY Over Upper Limit

L

L

A The measured NIBP value exceeds the module measurement range.

A The measured pressure is greater than the specified

NIBP measurement upper limit.

NIBP-YY Over Lower Limit L A The measured pressure is lower than the specified NIBP measurement lower limit.

YY represents diastolic pressure, mean pressure, or systolic pressure.


Measurement

IBP

Alarm message

NIBP Excessive Motion

NIBP Cuff Overpress.

NIBP Equip Err

NIBP Timeout

NIBP Measure Failed

NIBP Illegally Reset

YY Sensor Off

YY Sensor Fault

YY Disconnected

YY No Pulse

(YY represents an IBP label)

CO

2

CO

2

Sensor High Temp

CO

2

Sensor Low Temp

CO

2

Temp Overrange

L

L

H

L

L

L


A Check the patient’s condition and reduce the patient motion.

A The NIBP airway may be occluded. Check the airway and measure again.

A An error occurred during NIBP measurement and

A

A therefore the monitor cannot perform analysis correctly.

Check the patient’s condition and NIBP connections, or replace the cuff.

L A An illegal reset occurred during NIBP measurement.

Check if the airway is occluded.

M* A Check the sensor connection and reconnect the sensor.

M C Replace the sensor.

H

L

C The liquid way is disconnected from the patient, or the three-way valve is open to the air. Check the connection of the liquid way, or check the valve is open to the patient. If the problem remains, contact the Customer

Services Dept. for help.

A The catheter may be occluded. Please flush the catheter.

CO

CO

2

Airway Low Press.

CO

2

High Barometric Press.

CO

CO

2

CO

CO

2

CO

CO

CO

CO

CO

2

2

2

2

2

2

2

2

Airway High Press.

Low Barometric Press.

FilterLine Occluded

No Watertrap

Check Adapter

FilterLine Err

Zero Failed

System Err

Check Cal.

Check Airway

L

L

L

L

L

L

L

L

L

L

L

L

L

L

L

C Check, stop using or replace the sensor.

C Check, stop using or replace the sensor.

C The operating temperature of the CO

2

module goes beyond the specified range. After it restores within the specified range, the module will restart automatically.

C An error occurred in the airway pressure. Check the patient connection and patient circuit, and then restart

C the monitor.

C Check the CO

2

connections, make sure that the monitor application site meets the requirements, and check for

C special sources that affect the ambient pressure. Restart the monitor.

C The airway or watertrap was occluded. Check the airway and remove the occlusion.

B Check the watertrap connections.

A There is a problem with the airway adapter. Check, clean or replace the adapter.

C Check if there is a leak in the CO

2

sample line or the CO

2 sample line has been occluded.

A Check the CO

2

connections. After the sensor’s temperature becomes stabilized, perform a zero calibration again.

A Re-plug the module or restart the monitor.

C Perform a calibration.

C An error occurred to the airway.


Measurement

Power

System

Alarm message

CO

2

No Filterline

CO

2

No Sensor

CO

2

Main Board Err

CO

2

Checking Sensor L

CO

2

Replace Scrubber&Pump L

L

L

L

H

CO

2

15V Overrange

CO

2

Hardware Err

12V Too High

12V Too Low

H

H

H

H

5V Too High

5V Too Low

3.3V Too High

3.3V Too Low

No Battery

H

H

H

H

H

Low Battery

Battery Depleted

T1 battery to be protected and not work.

T1 battery aged. Replace the battery

Power Board Comm Err

L

H

RT Clock Need Reset

RT Clock Not Exist

IP Address Conflict

No CMS

Other Bed Disconnected

PWR interrupted. Check meas. state

Restoring Last Config. Failed

L

L

L

Loading Default Config.

Failed.

USB Drive Err

H

L

L

M

H

H

L

L

M


A Make sure that the filterline is connected.

A Make sure that the sensor is connected.

C There is a problem with the CO

2

module. Re-plug the

C module or restart the monitor.

C

C

C

C There is a problem with the system power supply.

C Restart the monitor.

C

C

C

C

C 1. Battery is not installed or poor contact: properly install the battery.

2. Battery circuit failure or battery failed: contact your service personnel.

C Connect the monitor to an external power source.

C Connect the monitor to an external power source.

C T1 battery will be soon protected and will not supply power. If you are going to use the T1 for patient transport, please replace the battery.

C T1 battery lifetime is expired. Replace the battery with a new one.

C Restart the monitor. If the problem persists, contact your service personnel.

C Internal backup battery cell fails. Contact your service personnel.

C Contact your service personnel.

A Set a new IP address.

A The monitor is disconnected from the CMS. Check network connection.

A Check network connection.

A Power supply failed accidently. Check the measurements when the monitor restarts.

A Restart the monitor. If the problem persists,there may be an EEPROM failure. Contact your service personnel.

A Restart the monitor. If the problem persists,there may be an EEPROM failure. Contact your service personnel.

A 1.

Disconnect the USB memory and reconnect it properly.

2.

If the problem persists, format the USB memory.

3.

If the problem still persists, replace the USB drive.


Measurement Alarm message

Storage Card Err

Storage Card Space Low

USB Drive Space Low

Read Dock E2PROM Error

Unknown Device

L

M

L

L

H

L


C Restart the monitor. If the problem persists, format the

SD card.

B The storage card has abnormal data. Format the storage card.

A Delete unnecessary data from the USB memory, or replace the USB memory.

C Disconnect the T1 from the docking station and reconnect it, or replace the external display.

A The external device fails, or is not supported by the T1, or is not connected properly. Reconnect the external device properly. If the problem persists, replace the external device.


FOR YOUR NOTES


E

Symbols and Abbreviations

E.1 Symbols

mV mW

MΩ nm rpm s min ml mm mmHg ms lb m mAh

Mb mg

Hz in kg kPa

L

ºF g

GHz

GTT h cc cm cmH2O dB

DS

μA

μV

μs

A

Ah bpm bps

ºC microampere microvolt

Microsecond ampere ampere hour beat per minute bit per second centigrade cubic centimeter centimeter centimeters of water decibel dyne second fahrenheit gram gigahertz gutta hour hertz inch kilogram kilopascal litre pound meter milliampere hour mega byte milligram minute milliliter millimeter millimeters of mercury millisecond millivolt milliwatt megaohm nanometer respirations per minute second

T1 Patient Monitor Operator’s Manual E-1

V

VA

Ω

W volt volt ampere ohm watt

+

=

<

>

≤

≥

±

×

–

%

/ minus, negative percent per; divide; or; none; not applicable plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply

E.2 Abbreviations

e

C.I.

CCI

CCU

CE

CFI

CIS

CISPR

AAMI

AC

Adu

Association for Advancement of Medical Instrumentation alternating current adult

AHA American Heart Association

Air Flow air flow

ANSI American National Standard Institute

Ao

Art aortic pressure arterial aVF aVL aVR awRR

BAP left foot augmented lead left arm augmented lead right arm augmented lead airway respiratory rate brachial arterial pressure

Base Flow base flow

BC burst count

BP blood pressure

BSA e body surface area blood temperature body temperature and pressure, saturated cardiac index

Continuous Cardiac Index cardiac (coronary) care unit

Conformité Européenne cardiac function index

Clinical Information System

International Special Committee on Radio Interference

E-2 T1 Patient Monitor Operator’s Manual

FPGA

GEDI

GEF

Hb

Hb-CO

HbO

2

HIS

HR

CPI

CPO

Cstat

CVP

DC

Des

Dia

DPI dPmx

DVI

ECG

EDV

CMOS

CMS

CO

2

COHb

Compl

CP complementary metal oxide semiconductor central monitoring system carbon dioxide carboxyhemoglobin compliance cardiopulmonary cardiac power index

Cardiac Power Output static compliance central venous pressure direct current desflurane diastolic dot per inch left ventricular contractility digital video interface electrocardiograph end-diastolic volume

EEC

EEG

EMC

EMG

EMI

ESU

Et

EtCO

2

EtN

2

O

EtO

European Economic Community electroencephalogram electromagnetic compatibility electromyography electromagnetic interference electrosurgical unit end-tidal end-tidal carbon dioxide end-tidal nitrous oxide ethylene oxide

EtO

2

ELWI

EVLW end-tidal oxygen extravascular lung water index extravascular lung water

Exp. Flow expiratory flow

Exp% inspiration termination level

FAP

FCC

FDA femoral arterial pressure

Federal Communication Commission

Food and Drug Administration

FEV1.0% first second forced expiratory volume ratio

Fi fraction of inspired field programmable gate array global end diastolic volume index global ejection fraction hemoglobin carbon mono-oxide hemoglobin oxyhemoglobin hospital information system heart rate


E-4

ITBV

LA

LAP

Lat

LCD

IEC

IEEE

IP

IT

ITBI

I:E

IBP

IBW

ICP

ICT/B

ICU

ID

I:E inspiratory-expiratory ratio invasive brood pressure ideal body weight intracranial pressure intracranial catheter tip pressure transducer intensive care unit identification inspiratory time: Expiratory time ratio

International Electrotechnical Commission

Institute of Electrical and Electronic Engineers internet protocol injectate temperature

Intrathoracic Blood Volume Index

Intrathoracic Blood Volume left arm left atrial pressure lateral liquid crystal display

LCW

LCWI left cardiac work left cardiac work index

Leak Comp leak compensation

LED

LL light emitting diode left leg

LVD

LVDS

LVET

LVSW

LVSWI low voltage directive low voltage differential signal left ventricular ejection time left ventricular stroke work left ventricular stroke work index

MAC minimum alveolar concentration

Art mean mean arterial pressure

MDD Medical Device Directive

MetHb

MRI methemoglobin magnetic resonance imaging

MRN

N/A

N

2

N

2

O

Neo medical record number not applied nitrogen nitrous oxide neonate

NIBP

O

2

O

2

% noninvasive blood pressure oxygen oxygen concentration

OR operating room oxyCRG oxygen cardio-respirogram

PA pulmonary artery

Papnea apnea pressure pArt-D diastolic artery pressure


TB

TD

Temp

TFC

TFI

TFT

Thigh

Toral

PVR

PVRI

PVPI

PPV pArt pCVP

R

RA

RAM

RAP pArt-M mean artery pressure pArt-S

PD systolic artery pressure photodetector

Ped

Pleth

PPV

PR

PVC pediatric plethysmogram

Pulse Pressure Variation pulse rate premature ventricular contraction pulmonary vascular resistance pulmonary vascular resistance index pulmonary vascular permeability index pulse pressure variation artery pressure central venous pressure right right arm random access memory right atrial pressure

SVRI

SVV

Sync

Sys

Taxil

SR

STR

SV

SVI

SVR

RR

SFM

SI

SpO

2

SQI

Rec

Resp

RHb record, recording respiration reduced hemoglobin

Rise Time% rise time

RL right leg respiration rate self-maintenance stroke index arterial oxygen saturation from pulse oximetry signal quality index suppression ratio systolic time ratio stroke volume

Stroke Volume Index systemic vascular resistance systemic vascular resistance index stroke volume variation synchronization systolic pressure axillary temperature

Blood Temperature temperature difference temperature thoracic fluid content thoracic fluid index thin-film technology time for the upper pressure level oral temperature


Tplat

Trect

Trise plateau time rectal temperature rise time

Tslope time for the pressure to rise to target pressure

Tube ID tube ID

UAP umbilical arterial pressure

UPS

USB uninterruptible power supply universal serial bus

UVP

VAC

WLAN umbilical venous pressure volts alternating current wireless local area network

WOB work of breathing

WOBimp imposed work of breathing

E-6 T1 Patient Monitor Operator’s Manual