Shenzhen BeneHeart D3, BeneHeart D2 Operator’s Manual

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BeneHeart D3/BeneHeart D2

Defibrillator/Monitor

Operator’s Manual

■ Release time: 2020-09

■ Revision: 9.0

Defibrillator/Monitor Operator’s Manual I

Intellectual Property Statement

WARNING

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.

Responsibility on the Manufacturer Party

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

All information contained in this manual is believed to be correct. Mindray shall 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.

• This equipment must be operated by skilled/trained clinical professionals.

• It is important for the hospital or organization that employs this equipment to carry out a

reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

II Defibrillator/Monitor Operator’s Manual

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

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 shall 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 such as fire and earthquake.

■ 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 enough.

■ Others not caused by instrument or part itself.

Company Contact

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan,

Shenzhen 518057, P.R.China

Website: www.mindray.com

E-mail Address: service@mindray.com

Tel: +86 755 81888998

Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

Defibrillator/Monitor Operator’s Manual III

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 question, please contact us.

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

Intended Audience

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

Illustrations

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

Conventions

■ Italic text is used in this manual to quote the referenced chapters or sections.

■ [ ] is used to enclose screen texts.

■ → is used to indicate operational procedures.

IV Defibrillator/Monitor Operator’s Manual

Contents

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

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

1.1.1 Dangers .................................................................................................................................................................................................1 - 1

1.1.2 Warnings ..............................................................................................................................................................................................1 - 1

1.1.3 Cautions ................................................................................................................................................................................................1 - 2

1.1.4 Notes ......................................................................................................................................................................................................1 - 3

1.2 Equipment Symbols .......................................................................................................................................................................................1 - 3

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

2.1 Equipment Introduction ...............................................................................................................................................................................2 - 1

2.2 Intended Use .....................................................................................................................................................................................................2 - 1

2.2.1 AED .........................................................................................................................................................................................................2 - 2

2.2.2 Manual Defibrillation .......................................................................................................................................................................2 - 2

2.2.3 Noninvasive Pacing ..........................................................................................................................................................................2 - 2

2.2.4 ECG .........................................................................................................................................................................................................2 - 2

2.2.5 Resp ........................................................................................................................................................................................................2 - 2

2.2.6 PR ............................................................................................

2.2

.7 SpO

2 ........................................................................................................................................................................................................................................................ 2 - 2

2.2.8 NIBP ......................................................................................

2.2.9 CO

2.2.10 CPR Feedback ................................................................................

2.3 Applied Parts .....................................................................................................................................................................................................2 - 3

.................................................................................................................2 - 2

..................................................................................................................2 - 2

..................................................................................................2 - 2

2.4 Main Unit ............................................................................................................................................................................................................2 - 3

2.4.1 Front View ............................................................................................................................................................................................2 - 3

2.4.2 Left View ...............................................................................................................................................................................................2 - 7

2.4.3 Right View ............................................................................................................................................................................................2 - 8

2.4.4 Rear View ..............................................................................................................................................................................................2 - 8

2.5 External Paddles ...............................................................................................................................................................................................2 - 9

2.6 Display Views .................................................................................................................................................................................................2 - 10

3 Basic Operations and Settings .........................................................................................................................................3 - 1

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

3.1.1 Unpacking and Checking ...............................................................................................................................................................3 - 1

3.1.2 Environmental Requirements .......................................................................................................................................................3 - 1

3.2 Basic Operation ................................................................................................................................................................................................3 - 2

3.2.1 Connecting the AC Mains ...............................................................................................................................................................3 - 2

3.2.2 Installing the Battery ........................................................................................................................................................................3 - 2

3.2.3 Turning On the Equipment ............................................................................................................................................................3 - 2

3.2.4 Starting Monitoring or Therapy ...................................................................................................................................................3 - 3

3.2.5 Using the Main Menu .......................................................................................................................................................................3 - 3

3.2.6 Using the Navigation knob ............................................................................................................................................................3 - 3

3.2.7 Editing Current Patient Information ...........................................................................................................................................3 - 4

3.2.8 Turning Off the Equipment ...........................................................................................................................................................3 - 4

3.2.9 Auto Restoring to Last Configuration ........................................................................................................................................3 - 4

3.3 Changing General Settings ..........................................................................................................................................................................3 - 5

3.3.1 Setting the Date and Time .............................................................................................................................................................3 - 5

3.3.2 Adjusting the Screen Brightness .................................................................................................................................................3 - 5

Defibrillator/Monitor Operator’s Manual 1

3.3.3 Changing Key Volume .....................................................................................................................................................................3 - 5

3.3.4 Selecting High Contrast Display ..................................................................................................................................................3 - 5

3.3.5 Adjusting Waveform Position ......................................................................................................................................................3 - 6

3.4 Analog Output .................................................................................................................................................................................................3 - 6

4 Alarms .................................................................................................................................................................................4 - 1

4.1 Alarm Categories .............................................................................................................................................................................................4 - 1

4.2 Alarm Levels ......................................................................................................................................................................................................4 - 1

4.3 Alarm Indicators ..............................................................................................................................................................................................4 - 2

4.3.1 Alarm Lamps .......................................................................................................................................................................................4 - 2

4.3.2 Audible Alarms ..................................................................................................................................................................................4 - 2

4.3.3 Alarm Messages .................................................................................................................................................................................4 - 2

4.3.4 Flashing Numerics ............................................................................................................................................................................4 - 3

4.3.5 Alarm Status Symbols ......................................................................................................................................................................4 - 3

4.4 Alarm Tone Configuration ...........................................................................................................................................................................4 - 3

4.4.1 Changing the Alarm Volume ........................................................................................................................................................4 - 3

4.4.2 Setting the Reminder Tones .........................................................................................................................................................4 - 3

4.4.3 Setting the Interval between Alarm Sounds ...........................................................................................................................4 - 3

4.5 Understanding the Alarm Setup Menu ...................................................................................................................................................4 - 4

4.5.1 Setting Alarm Properties for All Parameters ...........................................................................................................................4 - 4

4.5.2 Adjusting Alarm Limits Automatically ......................................................................................................................................4 - 4

4.6 Pausing Alarms ................................................................................................................................................................................................4 - 6

4.7 Switching Alarms Off .....................................................................................................................................................................................4 - 6

4.8 Switching Off Alarm Sounds .......................................................................................................................................................................4 - 6

4.9 Resetting Alarms .............................................................................................................................................................................................4 - 6

4.10 Latching Alarms ............................................................................................................................................................................................4 - 7

4.11 Clearing Technical Alarms .........................................................................................................................................................................4 - 7

4.12 Testing Alarms ...............................................................................................................................................................................................4 - 7

4.13 Actions When an Alarm Occurs ...............................................................................................................................................................4 - 8

5 Monitoring ECG .................................................................................................................................................................5 - 1

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

5.2 ECG Safety Information .................................................................................................................................................................................5 - 1

5.3 Monitoring View ..............................................................................................................................................................................................5 - 2

5.4 Preparing for ECG Monitoring and Measurement ..............................................................................................................................5 - 2

5.4.1 Preparing the Patient Skin ............................................................................................................................................................. 5 - 2

5.4.2 ECG Monitoring with Electrodes .................................................................................................................................................5 - 2

5.4.3 ECG Measurement with Electrode Pads ...................................................................................................................................5 - 3

5.4.4 ECG Measurement with External Paddles .....................................

5.4.5 Checking Paced Status ....................................................................................................................................................................5 - 5

5.5 ECG Display ....................................

...................................................................................................................................................................5 - 6

...........................................................................................5 - 5

5.6 Changing ECG Settings ................................................................................................................................................................................. 5 - 6

5.6.1 Selecting the Lead Type .................................................................................................................................................................5 - 6

5.6.2 Choosing the ECG Standard ..........................................................................................................................................................5 - 6

5.6.3 Selecting the Lead of Displayed ECG Waveform ................................................................................................................... 5 - 6

.6.4 Setting the ECG Waveform Layout .............................................................................................................................................5 - 7

.6.5 Changing ECG Waveform Size .....................................................................................................................................................5 - 7

.6.6 Changing ECG Waveform Speed .................................................................................................................................................5 - 7

2 Defibrillator/Monitor Operator’s Manual

5.6.7 Setting th

5.6.8 Switching On or Off the Notch Filter ..........................................................................................................................................5 - 7

5.6.9 Adjusting t

.7 Arrhythmia Analysis ........................................................................................................................................................................................5 - 8

5.7.1 Understanding the Arrhythmia Events .....................................................................................................................................5 - 8

5.7.2 Switching Arrhythmia Analysis On and Off .............................................................................................................................5 - 9

5.7.3 Changing Arrhythmia Alarm Settings ........................................................................................................................................5 - 9

7.4 Changing Arrhythmia Threshold Settings .............................................................................................................................5 - 10

5.7.5 Initiating Arrhythmia Relearning Manually ..........................................................................................................................5 - 10

5.7.6 Automat

.8 Calibrating ECG ............................................................................................................................................................................................. 5 - 11

.9 ECG Troubleshooting .................................................................................................................................................................................. 5 - 11

6 AED .....................................................................................................................................................................................6 - 1

6.1 AED Introduction .............................................................................................................................................................................................6 - 1

6.2 AED Safety Information .................................................................................................................................................................................6 - 1

6.3 AED View ............................................................................................................................................................................................................6 - 2

6.4 AED Procedure .................................................................................................................................................................................................6 - 2

6.5 Shock Advised ..................................................................................................................................................................................................6 - 3

6.6 No Shock Advised (NSA) ...............................................................................................................................................................................6 - 4

e ECG Filter .......................................................................................................................................................................5 - 7

he QRS Volume ............................................................................................................................................................5 - 8

ic Arrhythmia Relearn ................................................................................................................................................... 5 - 11

6.7 CPR ........................................................................................................................................................................................................................6 - 4

6.7.1 CPR Metronome .................................................................................................................................................................................6 - 4

6.8 AED Sound Recording ...................................................................................................................................................................................6 - 5

6.9 AED Setup ..........................................................................................................................................................................................................6 - 5

7 Manual Defibrillation ........................................................................................................................................................ 7 - 1

7.1 Manual Defibrillation Introduction ...........................................................................................................................................................7 - 1

7.2 Manual Defibrillation Safety Information ...............................................................................................................................................7 - 1

7.3 Manual Defibrillation View ...........................................................................................................................................................................7 - 2

7.4 Manual Defibrillation Procedure ................................................................................................................................................................7 - 3

7.4.1 Using Pediatric Paddles ...................................................................................................................................................................7 - 5

7.4.2 Using Internal Paddles .....................................................................................................................................................................7 - 5

7.5 Synchronized Cardioversion .......................................................................................................................................................................7 - 6

7.5.1 Performing Synchronized Cardioversion .................................................................................................................................7 - 7

7.5.2 Delivering Additional Synchronized Shocks ...........................................................................................................................7 - 7

7.5.3 Disabling the Sync Function .........................................................................................................................................................7 - 7

7.6 Remote Synchronized Cardioversion .......................................................................................................................................................7 - 8

7.7 Contact Impedance Indicator .....................................................................................................................................................................7 - 9

8 CPR Feedback ....................................................................................................................................................................8 - 1

8.1 CPR Feedback Introduction .........................................................................................................................................................................8 - 1

8.2 Operations with the CPR Sensor ................................................................................................................................................................8 - 1

8.2.1 Connecting the CPR Sensor ...........................................................................................................................................................8 - 1

8.2.2 Using CPR Filter ..................................................................................................................................................................................8 - 2

8.2.3 Viewing CPR Feedback ....................................................................................................................................................................8 - 3

8.2.4 Reviewing CPR Events .....................................................................................................................................................................8 - 3

8.2.5 Uploading CPR Data .........................................................................................................................................................................8 - 4

Defibrillator/Monitor Operator’s Manual 3

9 Noninvasive Pacing ...........................................................................................................................................................9 - 1

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

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

9.3 Pacing View .......................................................................................................................................................................................................9 - 2

9.4 Pacer Mode ........................................................................................................................................................................................................9 - 2

9.5 Preparing for Pacing ......................................................................................................................................................................................9 - 3

9.5.1 Demand Mode Pacing .....................................................................................................................................................................9 - 3

9.5.2 Fixed Mode Pacing ...........................................................................................................................................................................9 - 4

10 Monitoring Resp ............................................................................................................................................................10 - 1

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

10.2 Resp Safety Information .......................................................................................................................................................................... 10 - 1

10.3 Resp Display ................................................................................................................................................................................................ 10 - 1

10.4 Placing Resp Electrodes .......................................................................................................................................................................... 10 - 1

10.4.1 Optimizing Lead Placement for Resp ................................................................................................................................... 10 - 2

10.4.2 Changing Resp Settings ............................................................................................................................................................ 10 - 3

10.5 Resp Troubleshooting .............................................................................................................................................................................. 10 - 3

11 Monitoring PR ................................................................................................................................................................11 - 1

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

11.2 Adjusting Pulse Tone Volume ............................................................................................................................................................... 11 - 1

12 Monitoring SpO

12.1 SpO2 Introduction .................................................................................................................................................................................... 12 - 1

12.2 Identifying SpO

Modules ...................................................................................................................................................................... 12 - 1

12.3 SpO2 Safety Information ........................................................................................................................................................................ 12 - 1

12.4 SpO2 Measurement Limitations .......................................................................................................................................................... 12 - 2

12.5 SpO2 Display ............................................................................................................................................................................................... 12 - 3

12.6 SpO2 Monitoring Procedure .................................................................................................................................................................. 12 - 4

12.7 Changing SpO

Settings ......................................................................................................................................................................... 12 - 4

12.7.1 Changing the Speed of the Pleth Wave .............................................................................................................................. 12 - 4

12.7.2 Monitoring SpO

12.7.3 Sat-Seconds Alarm Management (for Nellcor SpO

12.7.4 Setting SpO

12.7.5 Setting SpO

12.7.6 Changing Averaging Time (for Masimo SpO

and NIBP on the Same Limb ................................................................................................................ 12 - 4

) ...................................................................................................... 12 - 4

Sensitivity (for Mindray SpO2) ...................................................................................................................... 12 - 5

Sensitivity (for Masimo SpO2) ...................................................................................................................... 12 - 5

) ................................................................................................................. 12 - 5

12.7.7 Enabling FastSAT (for Masimo SpO2) ................................................................................................................................... 12 - 5

12.7.8 Displaying SIQ (for Masimo SpO

12.7.9 Displaying PI (for Masimo SpO

) ......................................................................................................................................... 12 - 5

) ............................................................................................................................................ 12 - 6

12.7.10 Setting the Alarm Delay Time (for Masimo SpO2) ......................................................................................................... 12 - 6

12.8 SpO

Desat Alarm ...................................................................................................................................................................................... 12 - 6

12.9 Pitch Tone ..................................................................................................................................................................................................... 12 - 6

12.10 SpO

Troubleshooting .......................................................................................................................................................................... 12 - 6

12.11 Nellcor Information ................................................................................................................................................................................ 12 - 7

12.12 Masimo Information ............................................................................................................................................................................... 12 - 7

12.13 Masimo End-User License Agreement ............................................................................................................................................ 12 - 8

4 Defibrillator/Monitor Operator’s Manual

13 Monitoring NIBP ............................................................................................................................................................13 - 1

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

13.2 NIBP Safety Information ..........................................................................................................................................................................13 - 1

13.3 NIBP Measurement Limitations ............................................................................................................................................................13 - 2

13.4 Measurement Modes ................................................................................................................................................................................13 - 2

13.5 NIBP Display .................................................................................................................................................................................................13 - 2

13.6 NIBP Measurement Procedure ..............................................................................................................................................................13 - 3

13.6.1 Preparing the Patient .................................................................................................................................................................13 - 3

13.6.2 Preparing for NIBP Measurement ..........................................................................................................................................13 - 3

13.6.3 Starting and Stopping NIBP Measurements ...................................................................................................................... 13 - 3

13.6.4 Correcting the Measurement ..................................................................................................................................................13 - 3

13.6.5 Starting Auto NIBP Measurements ........................................................................................................................................ 13 - 3

13.6.6 Starting a STAT Measurement ................................................................................................................................................. 13 - 4

13.7 Setting Initial Cuff Inflation Pressure ..................................................................................................................................................13 - 4

13.8 Setting Pressure Unit ................................................................................................................................................................................13 - 4

13.9 NIBP Troubleshooting ..............................................................................................................................................................................13 - 4

14 Monitoring CO

14.1 CO2 Introduction ........................................................................................................................................................................................ 14 - 1

14.2 CO

14.3 CO

14.4 CO

14.5 Preparing for Measuring CO

Safety Information ............................................................................................................................................................................ 14 - 1

Measurement Limitations .............................................................................................................................................................. 14 - 1

Display ..................................................................................................................................................................................................14 - 2

14.5.1 Measuring CO2 Using the CO2 Module ................................................................................................................................14 - 2

14.5.2 Zeroing the CO2 Sensor .............................................................................................................................................................14 - 3

14.6 Changing CO

14.6.1 Changing CO

Settings ............................................................................................................................................................................14 - 4

Alarm Settings ................................................................................................................................................. 14 - 4

14.6.2 Setting Pressure Unit ..................................................................................................................................................................14 - 4

14.6.3 Changing CO

Wave Settings .................................................................................................................................................. 14 - 4

14.6.4 Changing CO2 Operating Mode .............................................................................................................................................14 - 4

14.6.5 Setting the Auto Standby Time ..............................................................................................................................................14 - 5

14.6.6 Setting the Apnea Alarm Delay .............................................................................................................................................. 14 - 5

14.6.7 Selecting Gas Compensations .................................................................................................................................................14 - 5

14.6.8 Setting Humidity Compensation ...........................................................................................................................................14 - 5

14.6.9 Barometric Pressure Compensation .....................................................................................................................................14 - 5

14.7 Removing the Exhaust Gases from the System ..............................................................................................................................14 - 6

14.8 CO

14.9 CO

Calibration ...........................................................................................................................................................................................14 - 6

Troubleshooting ................................................................................................................................................................................14 - 6

15 Marking Events ..............................................................................................................................................................15 - 1

16 Freezing Waveforms ......................................................................................................................................................16 - 1

16.1 Freezing Waveforms .................................................................................................................................................................................16 - 1

16.2 Reviewing Frozen Waveforms ............................................................................................................................................................... 16 - 1

16.3 Unfreezing Waveforms ............................................................................................................................................................................16 - 1

16.4 Recording Frozen Waveforms ...............................................................................................................................................................16 - 1

17 Review ............................................................................................................................................................................17 - 1

Defibrillator/Monitor Operator’s Manual 5

17.1 Reviewing Events ....................................................................................................................................................................................... 17 - 1

17.2 Reviewing Tabular Trends ...................................................................................................................................................................... 17 - 1

17.3 Reviewing CPR Events .............................................................................................................................................................................. 17 - 2

18 Data Management .........................................................................................................................................................18 - 1

18.1 Data Management Overview ................................................................................................................................................................ 18 - 1

18.2 Generating Patient Data ......................................................................................................................................................................... 18 - 1

8.3 Editing Archived Patient Information ................................................................................................................................................ 18 - 1

8.4 Reviewing Patient Events ....................................................................................................................................................................... 18 - 1

8.5 Exporting Patient Data ............................................................................................................................................................................ 18 - 1

19 Recording .......................................................................................................................................................................19 - 1

19.1 Using a Recorder ........................................................................................................................................................................................ 19 - 1

19.2 Recording Types ........................................................................................................................................................................................ 19 - 1

19.3 Starting Recordings .................................................................................................................................................................................. 19 - 2

19.3.1 Manually Starting Recordings ................................................................................................................................................. 19 - 2

19.3.2 Automatic Recordings ............................................................................................................................................................... 19 - 2

19.4 Stopping Recordings ................................................................................................................................................................................ 19 - 2

19.4.1 Stopping Recordings Manually .............................................................................................................................................. 19 - 2

19.4.2 Stopping Recordings Automatically .................................................................................................................................... 19 - 2

19.5 Setting the Recorder ................................................................................................................................................................................ 19 - 3

19.5.1 Selecting Waveforms for Recording ..................................................................................................................................... 19 - 3

19.5.2 Setting the Realtime Recording Length .............................................................................................................................. 19 - 3

19.5.3 Changing the Recording Speed ............................................................................................................................................. 19 - 3

19.5.4 Switching Gridlines On or Off ................................................................................................................................................. 19 - 3

19.6 Loading Paper ............................................................................................................................................................................................. 19 - 3

19.7 Removing Paper Jam ................................................................................................................................................................................ 19 - 4

19.8 Cleaning the Recorder Print Head ....................................................................................................................................................... 19 - 4

20 Network Connection .....................................................................................................................................................20 - 1

20.1 Network Introduction .............................................................................................................................................................................. 20 - 1

20.2 General Network Settings ...................................................................................................................................................................... 20 - 1

20.2.1 Selecting a Network Type ......................................................................................................................................................... 20 - 1

20.2.2 Storing Preset Sites ..................................................................................................................................................................... 20 - 1

20.2.3 Setting DNS ................................................................................................................................................................................... 20 - 1

20.3 Connecting the CMS ................................................................................................................................................................................. 20 - 2

20.4 Connecting the HL7 Server .................................................................................................................................................................... 20 - 2

21 Configuration Management .........................................................................................................................................21 - 1

21.1 Configuration Management Introduction ....................................................................................................................................... 21 - 1

21.2 Modifying Configuration Management Password ........................................................................................................................ 21 - 1

21.3 Viewing Configurations ........................................................................................................................................................................... 21 - 1

21.4 Exporting Configurations ....................................................................................................................................................................... 21 - 2

21.5 Importing Configurations ....................................................................................................................................................................... 21 - 2

21.6 Changing Configurations ....................................................................................................................................................................... 21 - 2

6 Defibrillator/Monitor Operator’s Manual

21.6.1 General Setup Menu ...................................................................................................................................................................21 - 2

21.6.2 Manual Defib Setup Menu ........................................................................................................................................................ 21 - 3

21.6.3 AED Setup Menu ..........................................................................................................................................................................21 - 4

21.6.4 Pacer Setup Menu ........................................................................................................................................................................21 - 5

21.6.5 CPR Setup Menu ........................................................................................................................................................................... 21 - 5

21.6.6 ECG Setup Menu ..........................................................................................................................................................................21 - 5

21.6.7 Resp Setup Menu .........................................................................................................................................................................21 - 8

21.6.8 SpO

Setup Menu ........................................................................................................................................................................ 21 - 8

21.6.9 PR Setup Menu .............................................................................................................................................................................21 - 9

21.6.10 NIBP Setup Menu ....................................................................................................................................................................... 21 - 9

21.6.11 CO

Setup Menu ......................................................................................................................................................................21 - 10

21.6.12 Alarm Setup Menu ..................................................................................................................................................................21 - 11

21.6.13 Waveform Setup Menu .........................................................................................................................................................21 - 11

21.6.14 Mark Event Setup Menu ........................................................................................................................................................21 - 12

21.6.15 Record Setup Menu ................................................................................................................................................................21 - 12

21.6.16 Data Management Setup Menu .........................................................................................................................................21 - 13

.6.17 Test Setup Menu ......................................................................................................................................................................21 - 13

21.6.18 Network Setup ..........................................................................................................................................................................21 - 13

21.6.19 Others Menu .............................................................................................................................................................................21 - 14

22 Battery ............................................................................................................................................................................22 - 1

22.1 Battery Introduction ..................................................................................................................................................................................22 - 1

22.2 Battery Safety Information .....................................................................................................................................................................22 - 1

22.3 Installing the Battery ................................................................................................................................................................................. 22 - 2

22.4 Battery Alarms .............................................................................................................................................................................................22 - 2

22.4.1 No Battery Alarm .......................................................................................................................................................................... 22 - 2

22.4.2 Low Battery Alarm .......................................................................................................................................................................22 - 2

22.4.3 Battery Aged Alarm .....................................................................................................................................................................22 - 2

22.4.4 Battery Error Alarm ......................................................................................................................................................................22 - 2

22.5 Conditioning the Battery .........................................................................................................................................................................22 - 3

22.6 Checking Battery Performance .............................................................................................................................................................22 - 3

22.7 Charging the Battery ................................................................................................................................................................................22 - 3

22.8 Storing Batteries .........................................................................................................................................................................................22 - 3

22.9 Recycling the Batteries .............................................................................................................................................................................22 - 4

23 Care and Cleaning .........................................................................................................................................................23 - 1

23.1 General Points .............................................................................................................................................................................................23 - 1

23.2 Cleaning ........................................................................................................................................................................................................23 - 2

23.3 Disinfecting ..................................................................................................................................................................................................23 - 2

23.4 Sterilization ..................................................................................................................................................................................................23 - 2

24 Maintenance ..................................................................................................................................................................24 - 1

24.1 Maintenance Introduction ...................................................................................................................................................................... 24 - 1

24.2 Maintenance Safety Information ..........................................................................................................................................................24 - 1

24.3 Routine Maintenance ............................................................................................................................................................................... 24 - 1

24.3.1 Auto Test .........................................................................................................................................................................................24 - 2

24.3.2 User Test ..........................................................................................................................................................................................24 - 3

24.4 Function Checks .........................................................................................................................................................................................24 - 5

Defibrillator/Monitor Operator’s Manual 7

24.4.1 Recorder Check ............................................................................................................................................................................ 24 - 5

24.4.2 ECG Cable Test .............................................................................................................................................................................. 24 - 5

24.4.3 Manual Defibrillation Test ........................................................................................................................................................ 24 - 5

24.4.4 Pacing Test ..................................................................................................................................................................................... 24 - 6

24.5 Preventive Maintenance ......................................................................................................................................................................... 24 - 7

24.5.1 Performing Tests in the Installation Mode ......................................................................................................................... 24 - 7

24.5.2 Electrical Safety Tests ................................................................................................................................................................. 24 - 7

25 Accessories .....................................................................................................................................................................25 - 1

25.1 ECG Accessories ......................................................................................................................................................................................... 25 - 1

25.1.1 ECG Electrodes ............................................................................................................................................................................. 25 - 1

25.1.2 12-pin Trunk Cable ...................................................................................................................................................................... 25 - 1

25.1.3 Lead Sets ......................................................................................................................................................................................... 25 - 2

25.1.4 Adapting Cable ............................................................................................................................................................................ 25 - 2

25.2 SpO

Accessories ....................................................................................................................................................................................... 25 - 3

25.2.1 Extension Cables .......................................................................................................................................................................... 25 - 3

25.2.2 SpO

Sensors ................................................................................................................................................................................. 25 - 3

25.3 NIBP Accessories ........................................................................................................................................................................................25 - 4

25.3.1 NIBP Hoses .....................................................................................................................................................................................25 - 4

25.3.2 Cuffs .................................................................................................................................................................................................. 25 - 4

25.4 CO

25.5 Therapy Accessories ................................................................................................................................................................................. 25 - 6

25.6 Miscellaneous ............................................................................................................................................................................................. 25 - 6

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

A.1 General Specifications ................................................................................................................................................................................. A - 1

A.1.1 Safety Specifications ...................................................................................................................................................................... A - 1

A.1.2 Physical Specifications ................................................................................................................................................................... A - 1

A.1.3 Display Specifications .................................................................................................................................................................... A - 1

A.1.4 Audio Indicators ............................................................................................................................................................................... A - 1

A.1.5 Interface Specifications ................................................................................................................................................................. A - 2

A.1.6 Signal Outputs Specifications ..................................................................................................................................................... A - 2

A.2 Defibrillator Specifications ......................................................................................................................................................................... A - 2

A.3 CPR Compression Specifications ............................................................................................................................................................. A - 5

A.4 Pacer Specifications ...................................................................................................................................................................................... A - 5

A.5 Monitor Specifications ................................................................................................................................................................................. A - 5

A.5.1 ECG Specifications (from ECG Lead Set) .................................................................................................................................. A - 5

A.5.2 ECG Specifications (from Defibrillation Electrodes) ............................................................................................................ A - 7

A.5.3 Resp Specifications ......................................................................................................................................................................... A - 9

A.5.4 SpO

Specifications ........................................................................................................................................................................ A - 9

A.5.5 PR Specifications ............................................................................................................................................................................ A - 10

A.5.6 NIBP Specifications .......................................................................................................................................................................A - 10

A.5.7 CO

Specifications ......................................................................................................................................................................... A - 11

A.6 Power Supply Specifications ...................................................................................................................................................................A - 12

A.6.1 External Power Supply Specifications .................................................................................................................................... A - 12

A.6.2 Battery Specifications ..................................................................................................................................................................A - 12

A.7 Recorder Specifications .............................................................................................................................................................................A - 14

A.8 Alarm Specifications ...................................................................................................................................................................................A - 14

8 Defibrillator/Monitor Operator’s Manual

A.9 Data Storage ..................................................................................................................................................................................................A - 14

A.10 Wi-Fi Specifications ...................................................................................................................................................................................A - 15

A.11 Environmental Specifications ...............................................................................................................................................................A - 15

B Mindray Shockable Rhythm Analysis Algorithm ............................................................................................................B - 1

B.1 Rhythm Recognition and Annotation Methodology ........................................................................................................................ B - 1

B.1.1 Database for Evaluation of Mindray Algorithm Performance .......................................................................................... B - 1

B.1.2 Rhythm Categories .......................................................................................................................................................................... B - 1

B.2 Mindray Shockable Rhythm Analysis Algorithm Performance ...................................................................................................... B - 2

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

C.1 EMC .....................................................................................................................................................................................................................C - 1

C.2 Radio Regulatory Compliance ................................................................................................................................................................... C - 4

D Defibrillator Shift Checklist ............................................................................................................................................. D - 1

E Alarm Messages ................................................................................................................................................................. E - 1

E.1 Physiological Alarm Messages ....................................................................................................................................................................E - 1

E.2 Technical Alarm Messages ...........................................................................................................................................................................E - 2

F Electrical Safety Inspection ..............................................................................................................................................F - 1

F.1 Power Cord Plug ..............................................................................................................................................................................................F - 1

F.2 Device Enclosure and Accessories .............................................................................................................................................................F - 1

F.2.1 Visual Inspection ................................................................................................................................................................................F - 1

F.2.2 Contextual Inspection .....................................................................................................................................................................F - 1

F.3 Device Labeling ................................................................................................................................................................................................F - 2

F.4 Protective Earth Resistance ..........................................................................................................................................................................F - 2

F.5 Earth Leakage Test ..........................................................................................................................................................................................F - 2

F.6 Patient Leakage Current ...............................................................................................................................................................................F - 2

F.7 Mains on Applied Part Leakage ..................................................................................................................................................................F - 3

F.8 Patient Auxiliary Current ...............................................................................................................................................................................F - 3

G Symbols and Abbreviations ............................................................................................................................................ G - 1

G.1 Units ....................................................................................................................................................................................................................G - 1

G.2 Symbols .............................................................................................................................................................................................................G - 2

G.3 Abbreviations and Acronyms .................................................................................................................................................................... G - 2

H Device Tracking ................................................................................................................................................................ H - 1

I Declaration of Conformity ..................................................................................................................................................I - 1

Defibrillator/Monitor Operator’s Manual 9

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10 Defibrillator/Monitor Operator’s Manual

1 Safety

DANGER

WARNING

CAUTION

NOTE

DANGER

WARNING

1.1 Safety Information

• Indicates an imminent hazard that, if not avoided, will result in death or serious injury.

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

injury.

• Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal

injury or product/property damage.

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

product.

1.1.1 Dangers

• The equipment delivers up to 360 J of electrical energy. Unless properly used as described in these

Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate this defibrillator unless thoroughly familiar with these operating instructions and the function of all controls, indicators, connectors, and accessories.

• Defibrillation current can cause operator or bystander severe injury or even death. Keep distance

from the patient or metal devices connected to the patient during defibrillation.

• Do not disassemble the defibrillator. It contains no operator serviceable components and

dangerous high voltages may be present. Contact authorized service personnel for repair.

• To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres,

flammable anesthetics, or other flammable agents (such as gasoline). Keep the equipment and the operating environment dry and clean.

1.1.2 Warnings

• 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.

• Make sure the synchronous input system is applied to this equipment and the input signal is correct

if necessary.

• To avoid risk of electric shock, this equipment must only be connected to a supply mains with

protective earth. If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on smart lithium-ion batteries.

Defibrillator/Monitor Operator’s Manual 1 - 1

• Ensure that the equipment is supplied with continuous electric power during work. Sudden power

CAUTION

failure leads to the loss of patient data.

• Use and store the equipment in specified environmental condition. The equipment and accessories

may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.

• This equipment is used for single patient at a time.

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

• Before each use, the operator must check the equipment condition to ensure that the equipment is

ready for operation.

• Medical electrical equipment which does not incorporate defibrillator protection should be

disconnected during defibrillation.

• Do not defibrillate a patient who lies on the wet ground.

• Do not touch the patient and live parts simultaneously.

• Do not touch the patient when connecting the peripheral equipment via the I/O signal ports to

prevent patient leakage current from exceeding the requirements specified by the standard.

• 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.

• Do not perform any functional check if the equipment is connected with a patient; otherwise the

patient might be shocked.

• Remain attentive to the patient during applying therapy. Delay in delivering a shock may result in a

rhythm that was analyzed as shockable converting spontaneously to non-shockable and could result in inappropriate delivery of a shock.

• For the treatment of patients with implantable pacemakers, place electrode pads or paddles away

from internal pacemaker generator if possible to help prevent damage to the pacemaker.

• Do not place the equipment or accessories in any position that might cause it to fall on the patient.

• Do not start or operate the equipment unless the setup was verified to be correct.

• 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.

• If any measurement seems questionable, first check the patient’s vital signs by alternate means and

then check the equipment for proper functioning.

• Physiological data and alarm messages provided by the equipment should not be used as the sole

basis for diagnosis or therapy decisions. They must be used in conjunction with clinical signs and symptoms. Misinterpretation of the measured values or other parameters can endanger the patient.

• Do not touch device connectors, recorder print head, battery connector or other live equipment if in

contact with the patient; otherwise patient injury may result.

• To ensure patient safety, use only parts and accessories specified in this manual.

• When disposing of the packaging material, be sure to observe the applicable waste control

regulations and keep it out of children’s reach.

1.1.3 Cautions

• Use of Manual Therapy security password requires the clinician to know and remember the

password. Failure to enter correct password will prevent the delivery of manual defibrillation, synchronized cardioversion and pacing therapy.

• 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 to avoid contaminating the environment.

• 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, X-ray equipment or MRI

1 - 2 Defibrillator/Monitor Operator’s Manual

devices are a possible source of interference as they may emit higher levels of electromagnetic

NOTE

radiation.

• 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 loop the patient cabling into a tight coil or wrap around the device, as this can damage the

patient cabling.

• Always install or carry the equipment properly to avoid damage caused by drop, impact, strong

vibration or other mechanical force.

• Dry the equipment immediately in case of rain.

• Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage

could occur.

1.1.4 Notes

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

• The equipment uses a mains plug as isolation means to the mains power supply. Do not locate the

equipment in a place difficult to operate the mains plug.

• During normal use, the operator shall stand in front of the equipment.

• Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when

needed.

• If the equipment operates on a DC power supply, a DC/AC adapter we supply should be used.

• This manual describes all features and options. Your equipment may not have all of them.

1.2 Equipment Symbols

Symbol Description Symbol Description

Refer to instruction manual/booklet General warning sign

Dangerous voltage Shock button

Manufacturer Date of manufacture

Battery indicator Alternating current

Equipotentiality Computer network

DEFIBRILLATION-PROOF TYPE CF APPLIED PA RT

DEFIBRILLATION-PROOF TYPE BF APPLIED PA RT

Protected against solid foreign objects of 1,0 mm Ø and greater

Protection against vertically falling water drops

Defibrillator/Monitor Operator’s Manual 1 - 3

Protected against solid foreign objects of 1,0 mm Ø and greater

Protected against splashing water

Symbol Description Symbol Description

Menu Graphical record

USB connector Input/output

Gas inlet Gas outlet

Humidity limitations Atmospheric pressure limitations

Temperature limitations Non-ionizing electromagnetic radiation

Stacking limit by number Keep dry

This way up Fragile; handle with care

Serial number Unlocking

Authorised representative in the European Community

NIBP start/stop key

The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive.

Note: The product complies with the Council Directive 2011/65/EU.

The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this

product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it.

* For system products, this label may be attached to the main unit only.

General symbol for recovery/recyclable

1 - 4 Defibrillator/Monitor Operator’s Manual

2 The Basics

2.1 Equipment Introduction

The BeneHeart D3/BeneHeart D2 Defibrillator/Monitor (hereinafter called the equipment) is a lightweight and portable defibrillator/monitor. It provides four operating modes: Monitor, Manual Defib, AED and Pacer.

■ Monitor Mode

In the Monitor mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple physiological parameters and waveforms including ECG, pulse oximetry (SpO2), respiration (Resp), pulse rate (PR), non-invasive blood pressure (NIBP) and carbon dioxide (CO

■ AED Mode

In the AED mode, the equipment automatically analyzes the patient’s ECG rhythm and indicates whether or not a shockable rhythm is detected. Voice prompts provide easy-to-follow instructions and patient information to guide you through the defibrillation process. Messages and flashing buttons are also presented to reinforce the voice prompts.

■ Manual Defib Mode

In the Manual Defib mode, the operator analyzes the patient’s ECG, and, if appropriate, follow this procedure:

1. Select the Manual Defib mode, adjust the energy level if necessary;

2. Charge; and

3. Deliver the shock.

Defibrillation may be performed through electrode pads, external and internal paddles. In the Manual Defib mode, you can also perform synchronized cardioversion. If desired, use of Manual Defib mode may be password protected.

■ Pacer Mode

The Pacer mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through electrode pads. Use of Pacer mode may also be password protected.

The equipment can be powered by smart lithium ion batteries which are rechargeable and maintenance-free. You can easily determine the remaining battery charge by viewing the battery power gauge displayed on the screen or by checking the indicator on the battery itself. An external AC mains or a DC power supply connected through a DC/AC adapter may also be used as a power source and for continuous battery charging.

The equipment can be connected to a Central Monitoring System (hereinafter called CMS) through wired and wireless networks.

The equipment automatically stores patient data in an internal storage card. You can also export the data through the USB port for viewing and editing on a PC through the data management software.

2.2 Intended Use

The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and semi-automated external defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG,

, Resp, PR, NIBP and CO2 monitoring.

SpO

The equipment is for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.

The equipment is intended to be used by qualified medical personnel trained in the operation of the equipment and qualified by training in basic life support, advanced cardiac life support or defibrillation.

Defibrillator/Monitor Operator’s Manual 2 - 1

2.2.1 AED

The AED mode is to be used only on cardio arrest patients. The patients must be:

■ Unresponsive

■ Not breathing or not breathing normally

2.2.2 Manual Defibrillation

Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized cardioversion is intended for termination of atrial fibrillation.

2.2.3 Noninvasive Pacing

Noninvasive pacing therapy is intended for patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

2.2.4 ECG

The ECG monitoring function is used to monitor and/or record the patient’s ECG waveform and heart rate.

2.2.5 Resp

The respiration monitoring function is used to continuously monitor the patient’s respiration rate and respiration waveform.

2.2.6 PR

The PR function is intended to measure patient’s arterial pulsation in arterial blood.

2.2.7 SpO

The SpO2 function is intended to measure patient’s oxygen saturation in arterial blood.

2.2.8 NIBP

The NIBP function is intended for non-invasive measurement of a patient’s arterial blood pressure.

2.2.9 CO

The CO2 function is intended for monitoring a patient’s exhaled carbon dioxide and to provide a respiration rate.

2.2.10 CPR Feedback

The CPR sensor can be connected to the equipment to provide real-time CPR feedback, including the chest compression depth, rate and interruption time.

2 - 2 Defibrillator/Monitor Operator’s Manual

2.3 Applied Parts

Alarm PauseNIBP MenuEvent

Handle External paddles

Area 1

Area 3

Area 2

Speaker

The applied parts of the equipment are:

■ ECG electrodes and leadwires

■ SpO

■ NIBP cuff

■ CO

■ External defibrillation paddles

■ Internal defibrillation paddles

■ Multifunction electrode pads

■ CPR sensor

sensor

sampling line/Nasal sampling cannula, airway adapter

2.4 Main Unit

2.4.1 Front View

Defibrillator/Monitor Operator’s Manual 2 - 3

Area 1

(1)

(3) (4) (5) (6)

(2)

(1) Alarm lamp

The Alarm lamp flashes in different color and frequenc

(2) Display screen

(3) AC power indicator

y to match the alarm level.

◆ Illuminated: the AC mains is connected.

◆ Off: the AC mains is not connected.

(4) Battery indicator

◆ Yellow: the battery is being charged.

◆ Green: the battery is fully charged or the equipment operates on battery power.

◆ Off: no battery is installed or battery fails.

(5) Status indicator

◆ Flashing (red cross): when a failure is detected, or when battery is not installed if [No

Battery] is configured as [Status Indicator On].

◆ Illuminated (green tick): when AC mains is connected, and the equipment operates

properly.

◆ Off: the equipment operates properly.

(6) Soft keys

They are corresponding with the soft key labels located immediately above. The labels of the soft keys changes according to the current operating mode.

2 - 4 Defibrillator/Monitor Operator’s Manual

Area 2

(1)

(4) (5)

(2)

(3)

(6) (7) (8)

(1) Lead Select button

Press this button to select the lead for the first ECG waveform.

(2) Gain select button

Press this button to select the size of the first ECG waveform.

(3) Microphone

It is used for voice recording in AED mode.

(4) NIBP button/Record button

◆ NIBP button (for the equipment configured with NIBP function): press this button

to start or stop NIBP measurements.

◆ Record button (for the equipment without NIBP function): press this button to start

a recording or stop the current recording.

(5) Alarm Pause button

Press this button to pause, reactivate or switch off the alarms.

(6) Mark Event button

Press it to manually mark specified events. If a menu has been open, pressing this button will close the menu.

(7) Main Menu button

If no menu is displayed on the screen, pressing it will enter the main menu. If there is a menu displayed, pressing it will close that menu.

(8) Navigation knob

◆ Rotate it clockwise or counterclockwise to move the cursor.

◆ Press it to confirm the selection.

Defibrillator/Monitor Operator’s Manual 2 - 5

Area 3

(1)

(3)

(4)

(2)

(1) Mode Select knob

Rotate this knob to select the operating mode or turn the equipment off.

(2) Energy Select button

In the Manual Defib mode, press this button to select the energy level.

(3) Charge button

Press this button to charge the defibrillator.

(4) Shock button

Press this button to deliver a shock to the patient.

2 - 6 Defibrillator/Monitor Operator’s Manual

2.4.2 Left View

(1)

(2)

(3)

(4) (5) (6)

(1) Recorder (2) ECG cable connector

(3) Gas oulet (4) NIBP cuff connector

(5) SpO

sensor connector (6) CO2 sampling line connector

Defibrillator/Monitor Operator’s Manual 2 - 7

2.4.3 Right View

(1)

(2)

(7)

(6)

(5)

(1)

(3) (4)

2.4.4 Rear View

(1) Therapy port

It is used to connect the paddles cable or pads cable.

2 - 8 Defibrillator/Monitor Operator’s Manual

(1) Hook

(1) (2) (2) (3)

(4)

(2) Battery

(3) Equipotential grounding terminal

When the defibrillator/monitor and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them.

(4) External power input

It connects an AC power cord or a DC/AC adapter to run the equipment respectively on the external AC mains or DC power supply.

(5) Network connector

It is a standard RJ45 connector.

(6) USB connector

(7) Multifunctional connector

It connects a CPR sensor, provides ECG output and defib synchronization input.

2.5 External Paddles

Sternum paddle Apex paddle

(1) Energy Select button

(2) Shock button

(3) Charge button

(4) Latch button

Press this button to get for pediatric paddles. For details, refer to 7.4.1Using Pediatric Paddles.

Defibrillator/Monitor Operator’s Manual 2 - 9

2.6 Display Views

(9) (8) (7)

(11)

(1) (2) (3) (4) (5)

(10)

(6)

(12)

A typical screen in the Manual Defib Mode is shown below.

(1) Patient Information area

This area shows patient name, patient category, paced status, and current date and time.

indicates that the patient has an implanted pacemaker.

(2) Alarm status symbols

This area shows the alarm status. For details, refer to 4.3.5Alarm Status Symbols.

(3) Physiological Alarm area

This area shows physiological alarm messages. When multiple alarms occur, they will be displayed circularly.

(4) Technical Alarm area

This area shows technical alarm messages and prompt messages. When multiple messages occur, they will be displayed circularly.

(5) Battery Status indicator

It indicates battery status. For details, refer to 22Battery.

(6) Parameter area

This area shows measurement parameters. Each measurement module has a parameter block and the parameter name is displayed at the upper left corner.

(7) Soft Key area

The soft key labels correspond to the soft key buttons located immediately below. The labels of the soft keys change according to the current display view and function. Soft key labels appearing as blank indicate that the soft key is inactive.

(8) Prompt area

This area shows the prompt information.

(9) Runtime area

This area shows the operating time since the equipment is turned on.

(10) Auxiliary Parameter area

This area shows parameters that cannot be displayed in the parameter area. When this area cannot accommodate all parameters, the excess parameters will automatically occupy the area of last waveform.

2 - 10 Defibrillator/Monitor Operator’s Manual

(11) Manual Defib information area

This area shows the selected defibrillation energy, shock counter as well as prompts related to manual defibrillation.

(12) Waveform area

This area shows measurement waveforms. The waveform label is displayed at the upper left corner of the waveform.

Defibrillator/Monitor Operator’s Manual 2 - 11

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2 - 12 Defibrillator/Monitor Operator’s Manual

3 Basic Operations and Settings

WARNING

CAUTION

WARNING

NOTE

3.1 Equipment Installation

• The equipment shall be installed by personnel authorized by the manufacturer.

• The software copyright of the equipment is solely owned by the manufacturer. No organization or

individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

• 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 is 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 the manufacturer.

• If it is not evident from the equipment specifications whether a particular combination is hazardous,

for example, due to summation of leakage currents, consult the manufacturers or else an expert in the field, to ensure the necessary safety of all devices concerned will not be impaired by the proposed combination.

• The docking station is part of the equipment. Use only the specified docking station.

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 the manufacturer. 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. If you have any question, please contact us.

• When disposing of the packaging material, be sure to observe the applicable waste control

regulations and keep it out of children’s reach.

• The equipment might be contaminated during storage and transport. 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.

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

reshipped.

3.1.2 Environmental Requirements

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

The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. If the equipment is installed in a cabinet, sufficient space in front and behind shall be left for convenient operation, maintenance and repair. Moreover, to maintain good ventilation, the equipment shall be at least 2 inches (5 cm) away from around the cabinet.

Defibrillator/Monitor Operator’s Manual 3 - 1

When the equipment is moved from one place to another, condensation may occur as a result of temperature or

NOTE

WARNING

humidity difference. In this case, never start the system before the condensation disappears.

• Make sure that the operating environment of the equipment meets the specific requirements.

Otherwise unexpected consequences, e.g. damage to the equipment, could result.

• The equipment use a mains plug as isolation means to the mains power supply. Do not locate the

equipment in a place difficult to operate the mains plug.

3.2 Basic Operation

3.2.1 Connecting the AC Mains

The equipment is powered by AC power supply. Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated besides the AC power input.

1. Connect the female end of the power cord with the AC power input.

2. Connect the male end of the power cord with a wall AC outlet.

3. Check that the power indicator is on.

The AC power indicator is off if the AC mains is not connected. When AC mains is connected, the AC power indicator is illuminated in green.

• Always use the accompanying power cord delivered with the equipment.

• Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of

the power line are the same as those indicated besides the AC power input.

• Use the cable retainer to secure the power cord to prevent it from falling off.

• Use the battery if the integrity of the protective earth conductor or the protective earthing system in

the installation is in doubt.

3.2.2 Installing the Battery

The equipment is designed to operate on battery power when external power supply is not available. For more information, refer to 22Battery.

3.2.3 Turning On the Equipment

Before turning on the equipment, perform the following inspections:

1. Check for any mechanical damage and make sure that all external cables and accessories are properly connected.

2. Connect the power cord to the AC power source. If you run the equipment on battery power, ensure that the battery is sufficiently charged. If you run the equipment on DC power supply, a DC/AC adapter we supply should be used.

To turn on the equipment, turn the Mode Select knob to the desired mode.

After the start-up screen is displayed, the equipment gives a beep, and meanwhile, the alarm lamp is illuminated in yellow, and then turns red, and then turns off.

■ If the equipment is t

when the alarm lamp turns off.

■ If the equipment is turned on by entering the Pacer mode or Monitor m ode, the alarm system is activated

when the alarm lamp turns off.

urned on by entering the AED mode or Manual Defib mode, the alarm system is off

3 - 2 Defibrillator/Monitor Operator’s Manual

WARNING

• Do not use the equipment for any monitoring or therapy procedure on a patient if you suspect it is

NOTE

(1)

(2)

(3)

not working properly, or if it is mechanically damaged. Contact your service personnel or Mindray.

• Check that visual and auditory alarm signals are presented correctly when the equipment is

powered on. Do not use the equipment for any monitoring procedure on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or Mindray.

3.2.4 Starting Monitoring or Therapy

1. Decide which measurements or therapy you want to make.

2. Check that the patient cables and sensors are correct.

3. Connect the required patient cables and sensors.

4. Enter the appropriate operating mode and check that the settings are proper for your patient.

For details on performing patient monitoring and therapy, refer to the corresponding sections.

3.2.5 Using the Main Menu

To enter the main menu, press the Main Menu button on the front panel.

Other menus are similar to the main menu and contain the following parts:

(1) Heading

(2) Main body:

Displays options, buttons, prompt messages, etc. Pressing the menu button with “>>” enters a submenu with additional options or information.

(3) Exit button

3.2.6 Using the Navigation knob

■ Displaying a submenu

Rotate the Navigation knob to move the cursor on the desired item of the main menu, and then press the Navigation knob.

■ Inputting information

1. Rotate the Navigation knob to move the cursor on the desired textbox of a menu, and then press the knob.

2. Rotate the Navigation knob to move the cursor on the desired character to be inputted, and then press the Navigation knob.

◆ Select [DEL] to delete the entire entry.

◆ Select to access uppercase letters.

◆ Select [OK] to confirm the entry and close the on-screen keyboard.

3. Repeat step 2 to complete the information input.

Defibrillator/Monitor Operator’s Manual 3 - 3

4. Rotate the Navigation knob to move the cursor on [Ok], and then press the Navigation knob to save the

NOTE

information inputted.

■ Changing settings

Changing the ECG lead in the Monitor mode is taken as an example below:

1. Rotate the Navigation knob to move the cursor on the ECG lead label

2. Press the Navigation knob to highlight the selection .

3. Rotate the Navigation knob until you find the desired item, and then press the Navigation knob to confirm the selection.

3.2.7 Editing Current Patient Information

The patient name/bed number (configurable), patient category and paced status of the current patient are displayed in the upper left corner of the main screen.

1. Press the Main Menu button on the front panel, and then select [Patient Demographics >>].

2. Make changes as desired.

◆ Set [Patient Cat.] to change the patient category. You can also rotate the Navigation knob to move

the cursor on the patient category of the main screen, press and rotate the Navigation knob to change the patient category.

◆ Edit patient name or bed number. You can set the patient information type displayed in the upper left

corner of the main screen by selecting [General Setup] through the Configuration Main menu.

◆ Set paced status: when the [Paced] is set to [Ye s ], a paced symbol is displayed in the upper left

corner of the main screen.

3. Select [Others >>] to edit more patient information.

If the equipment is connected to the CMS, the current patient name, bed number, MRN, department, height, weight, admit date or doctor information can also be changed on the CMS.

3.2.8 Turning Off the Equipment

1. Check that the patient monitoring or therapy is completed.

2. Disconnect the patient cables and sensors from the patient.

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

4. Turn the Mode Select Knob to Off. After 10 seconds, the equipment is shut down.

• To completely disconnect the power supply, unplug the power cord.

3.2.9 Auto Restoring to Last Configuration

During operation, you may make changes to some settings. However, these changes may not be saved as user configuration. To prevent the changes from losing in case of sudden power failure, the equipment saves the settings in real time. The saved settings are the latest configuration. In case of power failure, the equipment loads the latest configuration if restarts within 60 seconds; it load the user configuration if restarts 120 seconds later after the power failure; it may load either the latest configuration or the user configuration if restarts between 60 and 120 seconds after the power failure.

3 - 4 Defibrillator/Monitor Operator’s Manual

3.3 Changing General Settings

3.3.1 Setting the Date and Time

Before putting the equipment into use for the first time, you should check and set the system date and time in accordance with your local time.

To set the system time, you can choose any of the following ways:

■ Using the Navigation knob

1. Use the Navigation knob to move the cursor on the system time, and press the Navigation knob.

2. Set the system time.

3. Select [Confirm].

■ Through the Configuration Main menu

1. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → enter the required password.

2. Select [General Setup], and set the system time.

3. Select [Return].

■ Through the Configuration View menu

1. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → [View Config].

2. Select [General Setup], and set the system time. You cannot select date format and time format in this case.

3. Select [Return].

hrough the CMS

■ T

If connected to the CMS, the CMS automatically synchronize the system time to the equipment, and you cannot use the Navigation knob to change the system time on the equipment. For details on connecting the CMS, refer to 20.3Connecting the CMS.

If the system time is changed through the Configuration Main menu or Configuration View menu, the equipment will restart. If the system time is changed using the Navigation knob, or from the CMS, the equipment will generate a event to remind you.

3.3.2 Adjusting the Screen Brightness

1. Press the Main Menu button on the front panel, and then select [Others >>].

2. Set [Brightness] to an appropriate level. 10 is the brightest, and 1 is the least bright.

You can also change the screen brightness by selecting [Others] from the Configuration Main menu.

3.3.3 Changing Key Volume

1. Press the Main Menu button on the front panel, and then select [Others >>].

2. Select [Key Volume] and then select an appropriate value. 0 means key volume off and 10 is the maximum volume.

You can also change key volume by selecting [Others] from the Configuration Main menu.

3.3.4 Selecting High Contrast Display

The equipment has the function of high contrast display so that you can view the display under high ambient illumination.

To enable or disable the high contrast display:

■ In the Monitor, Manual Defib or Pacer mode

Press the Main Menu button on the front panel, and then select [High Contrast] to enable the high contrast display. To disable the high contrast display, select [Full Color] in the main menu.

Defibrillator/Monitor Operator’s Manual 3 - 5

■ In the AED mode

Press the [High Contrast] soft key to enable the high contrast display. To disable the high contrast display, press the [Full Color] soft key.

Once [High Contrast] is selected, the high contract display remains when you change the operating mode. However, the setting will not be saved if the equipment is turned off.

3.3.5 Adjusting Waveform Position

1. Press the Main Menu button on the front panel, and then select [Others >>]→ [Waves >>].

2. Set [Wave 2] and [Wave 3]. [Wave 1] is always ECG1, which is unchangeable.

You can also change waveform position by selecting [Waveform Setup] from the Configuration Main menu.

3.4 Analog Output

The equipment is configured with a multifunction connector for ECG analog output.

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4 Alarms

WARNING

Alarms triggered by a vital sign that appears abnormal or by technical problems of the equipment, are indicated to you by visual and audible alarm indications.

• A potential hazard exists if different alarm presets are used for the same or similar device in any

single area, e.g. an intensive care unit or cardiac operating room.

• If the equipment is connected to a CMS, remote suspension, inhibition, silence and reset of

monitoring alarms via the CMS may cause a potential hazard. For details, refer to the operator’s manual of the CMS.

• 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 make sure that the audio alarm volume level is adequate in your care environment. Always keep the patient under close surveillance.

4.1 Alarm Categories

By nature, the equipment’s alarms can be classified into three categories: physiological alarms, technical alarms and prompt messages.

1. Physiological alarms

Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set alarm limits or by an abnormal patient condition. Physiological alarm messages are displayed in the physiological alarm area. In the AED mode, no physiological alarm will be presented.

2. Technical alarms

Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion due to improper operation or system failure. Technical alarm messages are displayed in the technical alarm area.

3. Prompt messages

As a matter of fact, prompt messages are not alarm messages. Apart from the physiological and technical alarms, the equipment also shows some messages indicating system status. Messages of this kind are usually displayed in the prompt area. Therapy-related prompts are shown in corresponding information area. Some special prompts are shown in dialog boxes.

4.2 Alarm Levels

By severity, alarms can be classified into three categories: high level alarms, medium level alarms and low level alarms.

High level Indicate that your patient is in a life

Physiological alarms Technical alarms

Indicate a severe device malfunction or an improper threatening situation, such as Asystole, Vfib/Vtac and so forth, and an emergency treatment is demanded.

operation, which may result that the equipment cannot

detect critical patient status or may cause therapy failed, and

thus threaten the patient’s life, such as low battery.

Medium level Indicate that your patient’s vital signs

appear abnormal and an immediate treatment is required.

Low level Indicate that you patient’s vital signs

appear abnormal and an immediate treatment may be required.

Defibrillator/Monitor Operator’s Manual 4 - 1

Indicate a device malfunction or an improper operation,

which may not threaten the patient’s life but may

compromise patient monitoring or therapy.

Indicate a device malfunction or an improper operation,

which may compromise a certain function but will not

threaten the patient’s life.

4.3 Alarm Indicators

NOTE

When an alarm occurs, the equipment indicates it to you through visual or audible alarm indications.

■ Alarm lamp

■ Alarm tones

■ Alarm message

■ Flashing numeric

• When multiple alarms of different levels occur simultaneously, the equipment will select the alarm

of the highest level and give visual and audible alarm indications accordingly. Alarm messages will be displayed circularly.

• 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 to say, when an exclusive physiological alarm and a normal high level physiological alarms are triggered simultaneously, only alarm message of the exclusive physiological alarm is displayed.

4.3.1 Alarm Lamps

If an alarm occurs, the alarm lamp will flash. The color and flashing frequency match the alarm level as follows:

◆ High level alarms: the lamp quickly flashes red with frequency of 1.4 to 2.8 Hz, duty ratio of 20 to 60%.

◆ Medium level alarms: the lamp slowly flashes yellow with frequency of 0.4 to 0.8 Hz, duty ratio

◆ Low level alarms: the lamp lights yellow without flashing, with duty ratio of 100%.

4.3.2 Audible Alarms

The equipment uses different alarm tone patterns to match the alarm level:

◆ High level alarms: triple + double + triple + double beeps.

◆ Medium level alarms: triple beeps.

◆ Low level alarms: single beep.

4.3.3 Alarm Messages

When an alarm occurs, the alarm message will appear in the technical or physiological alarm area. For physiological alarms, the asterisk symbols (*) before the alarm message match the alarm level as follows:

◆ High level alarms: ***

◆ Medium level alarms: **

◆ Low level alarms: *

of 20 to 60%.

Additionally, the alarm message has different background color which matches the alarm level.

■ For physiological alarms

◆ High level alarms: red

◆ Medium level alarms: yellow

◆ Low level alarms: yellow

4 - 2 Defibrillator/Monitor Operator’s Manual

■ For technical alarms

NOTE

◆ High level alarms: red

◆ Medium level alarms: yellow

◆ Low level alarms:

4.3.4 Flashing Numerics

If an alarm triggered by an alarm limit violation occurs, the numeric of the measurement in alarm will flash every second, and corresponding alarm limit will also flash at the same frequency indicating the alarm limit is violated.

4.3.5 Alarm Status Symbols

Apart from the aforementioned alarm indicators, the equipment still uses the following symbols telling the alarm status:

Alarm pause: indicates alarms are paused.

Alarm reset: indicates alarm are reset.

Audio off: indicates alarm sounds are turned off.

Alarm off: indicates the system is in alarm off status.

lue

4.4 Alarm Tone Configuration

4.4.1 Changing the Alarm Volume

1. Press the Main Menu button on the front panel, and then select [Alarm Setup >>] .

2. Set [Alm Volume] to an appropriate level.

◆ If [Audio Off] is enabled, alarm volume can be set to a value between 0 and 10, in which 0 means audio off and 10 the maximum volume level.

◆ If [Audio Off] is disabled, alarm volume can be set to a value between 1 and 10, in which 1 is the minimum volume level and 10 the maximum.

The setting of alarm volume will not be saved when the equipment is powered off.

You can also disable or enable [Audio Off], set the alarm volume by selecting [Alarm Setup] from the Configuration Main menu. In this case, the setting will be saved.

• You cannot adjust the alarm volume when an alarm is switched off.

4.4.2 Setting the Reminder Tones

When alarms or alarm sounds are turned off, the equipment gives a reminder tone of a single beep every 60 seconds.

The reminder tone is switched off by default. You can switch on [Reminder Tone] by selecting [Alarm Setup] from the Configuration Main menu. You can also change the reminder volume. The default reminder volume is [Med].

4.4.3 Setting the Interval between Alarm Sounds

1. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → enter the required password.

2. Select [Alarm Setup].

3. Respectively set [High Level Alarm (s)], [Med Level Alarm (s)] and [Low Level Alarm (s)].

Defibrillator/Monitor Operator’s Manual 4 - 3

WARNING

• Do not rely exclusively on audible alarm system. Setting alarm volume to a low level may result in a

WARNING

NOTE

hazard to the patient. Always keep the patient under close surveillance.

4.5 Understanding the Alarm Setup Menu

Press the Main Menu button on the front panel, and then select [Alarm Setup >>] to enter the [Alarm Setup] menu.

4.5.1 Setting Alarm Properties for All Parameters

In the main menu, select [Alarm Setup >>] → [Para. Alarm >>] to enter the [Para. Alarm] menu, where you can review and set alarm limits, alarm switches, alarm level and alarm recordings for all parameters.

■ When a parameter alarm is switched on, the equipment gives alarm indications in accordance with the

preset alarm level and stores related waveforms and parameter values.

■ When a parameter alarm is switched off, the alarm off symbol is displayed in the parameter window.

For NIBP, the alarm off symbol is displayed only when all the NIBP alarms are switched off simultaneously.

■ When the measurement’s [On/Off] and [Record] are set to [On], automatic recording of all the

measurement numerics and related waveforms is possible when a measurement alarm occurs.

■ When [Defaults] is selected, all settings restored to the defaults.

You can also set parameter alarm properties by selecting a parameter area and select [Para. Alarm >>] in the pop-up menu.

• Make sure that the alarm limits settings are appropriate for your patient before patient monitoring.

• Setting the alarm limit to an extreme value may cause the alarm system to be ineffective. For

example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration, do not set the SpO2 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.

• You cannot simultaneously switch on HR and PR alarms. In the case that PR alarm is on, switching on

HR alarm will automatically turn off PR alarm, and vice versa.

4.5.2 Adjusting Alarm Limits Automatically

The equipment can automatically adjust the patient’s alarm limits according to the measured vital signs. When [Auto Limits] is selected, the equipment automatically calculates alarm limits based on the latest measured parameter values.

To enable auto alarm limits, press the Main Menu button on the front panel, and then select [Alarm Setup >>] → [Para. Alarm >>] → [Auto Limits].

You can also enable auto alarm limits by selecting a parameter area and then select [Para. Alarm >>]→ [Auto Limits].

When auto alarm limits have been applied, you can manually adjust the alarm limits through the [Para. Alarm] menu so that they are appropriate for your patient.

The equipment calculates the auto limits based on the following rules.

4 - 4 Defibrillator/Monitor Operator’s Manual

NOTE

Module Parameter Low alarm limit High alarm limit Auto alarm limits range

Adult/pediatric Neonate Adult/pediatric Neonate

ECG HR HR×0.8 or 40

Resp RR RR×0.5 or 6/min

SpO

NIBP NIBP-S SYS×0.68 +

SpO

PR PR×0.8 or 40

NIBP-D Dia×0.68 +

NIBP-M Mean×0.68 +

bpm (whichever is greater)

(whichever is greater)

Same as the default alarm limit

bpm (whichever is greater)

10mmHg

6mmHg

8mmHg

(HR-30) or 90 bpm (whichever is greater)

(RR-10) or 30/ min (whichever is greater)

Same as the default alarm limit

(PR-30) or 90 bpm (whichever is greater)

(SYS-15) or 45mmHg (whichever is greater)

(Dia-15) or 20mmHg (whichever is greater)

(Mean-15) or 35mmHg (whichever is greater)

HR×1.25 or 240 bpm whichever is lower)

RR×1.5 or 30/ min (whichever is lower)

Same as the default alarm limit

PR×1.25 or 240 bpm whichever is lower)

SYS×0.86 + 38mmHg

Dia×0.86 + 32mmHg

Mean×0.86 + 35mmHg

(HR + 40) or 200 bpm whichever is lower)

(RR+25) or 85/ min (whichever is lower)

Same as the default alarm limit

(PR + 40) or 200 bpm whichever is lower)

(SYS + 15) or 105mmHg (whichever is lower)

(Dia + 15) or 80mmHg (whichever is lower)

(Mean + 15) or 95mmHg (whichever is lower)

Adult/pediatric: 35 to 240 Neonate: 55 to 225

Adult/pediatric: 6 to 55 Neonate: 10 to 90

Same as the measurement range

Adult/pediatric: 35 to 240 Neonate: 55 to 225

Adult: 45 to 270 Pediatric: 45 to 185 Neonate: 35 to 115

Adult: 25 to 225 Pediatric: 25 to 150 Neonate: 20 to 90

Adult: 30 to 245 Pediatric: 30 to 180 Neonate: 25 to 105

EtCO

FiCO

awRR awRR×0.5 or 6/

0-32mmHg: remains unchanged

32-35mmHg: 29mmHg

35-45mmHg: EtCO

-6mmHg

45-48mmHg: 39mmHg

>48mmHg: remains unchanged

N/A N/A Same as the

min (whichever is greater)

0-32mmHg: remains unchanged

32-35mmHg: 29mmHg

35-45mmHg: EtCO2-6mmHg

45-48mmHg: 39mmHg

>48mmHg: remains unchanged

awRR-10 or 30/ min (whichever is greater)

0-32mmHg: remains unchanged

32-35mmHg: 41mmHg

35-45mmHg: EtCO2+6mmHg

45-48mmHg: 51mmHg

>48mmHg: remains unchanged

default alarm limit

awRR×1.5 or 30/ min (whichever is lower)

0-32mmHg: remains unchanged

32-35mmHg: 41mmHg

35-45mmHg: EtCO2+6mmHg

45-48mmHg: 51mmHg

>48mmHg: remains unchanged

Same as the default alarm limit

awRR+25 or 85/ min (whichever is lower)

Same as the measurement range

Adult/pediatric: 6 to 55 Neonate: 10 to 90

• You can enable auto alarm limits only when the current parameter measurement is within the auto

alarm limits range.

Defibrillator/Monitor Operator’s Manual 4 - 5

4.6 Pausing Alarms

You can temporarily disable alarm indicators by pressing the Alarm Pause button on the front panel. When alarms are paused:

■ For physiological alarms, no alarm indication is shown. New physiological alarm 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 alarm 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 Alarm Pause button .

The default alarm pause time is 2 minutes. To change alarm pause time:

1. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → enter the required password.

2. Select [Alarm Setup] → [Alarm Pause Time] and then select an appropriate value.

4.7 Switching Alarms Off

When an alarm is switched off, the alarm status is the same with that when an alarm is paused.

Alarms are switched off when:

■ The Alarm Pause button is pressed if the [Alarm Pause Time] is set to [Permanent].

■ The operating mode is switched to the Manual Defib mode.

■ Synchronized cardioversion is exited when operating in the Manual Defib mode.

The alarm off status is exited when:

■ The Alarm Pause button is pressed.

■ Sync Defib is switched on in the Manual Defib mode.

4.8 Switching Off Alarm Sounds

In the event that [Audio Off] is enabled through the Configuration Main menu, to switch off the alarm tone, set [Alm Volume] to 0 while operating in the Monitor mode, Manual Defib mode or Pacer mode. In the audio off

status, the audio off symbol appears in the sound symbol area. In this case, the alarm status is the same with that when alarm tones are paused.

The audio off status is exited when:

■ [Audio Off] is set to [Disabled] by selecting [Alarm Setup] from the Configuration Management Main

menu.

■ The Alarm Pause button is pressed. In this case, the equipment enters the alarm paused status and

the alarm volume is reset to the default level. the alarm pause symbol is displayed in the sound symbol area.

■ Operating mode is switched.

■ Alarm volume is changed to a value between 1 and 10.

4.9 Resetting Alarms

By pressing the [Alarm Reset] soft key, you can reset the alarm system and enable the alarm system to respond to a subsequent alarm condition.

For physiological alarms, when the alarm system is reset:

■ The alarm sound is reset.

■ A √ appears before the alarm message.

■ The alarm reset symbol appears in the alarm symbol area.

4 - 6 Defibrillator/Monitor Operator’s Manual

■ The parameter numeric and alarm limits still flash.

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

the alarm reset symbol

■ Some technical alarms are changed to the prompt messages.

■ Some technical alarms are cleared. The equipment gives no alarm indications.

For details about the indications of technical alarms when the alarm system is reset, refer to E.2Technical Alarm Messages.

4.10 Latching Alarms

The latching setting for physiological alarms defines how alarm indicators behave if you do not reset the alarms.

■ 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 is 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.

To latch a physiological alarm:

1. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → enter the required password.

2. Select [Alarm Setup] and set [Latching Alarms] to [Ye s ].

appears in the alarm symbol area.

Only physiological alarms can be latched. You can clear the latched alarms by pressing the Alarm Pause button on the front panel .

4.11 Clearing Technical Alarms

Technical alarms give different alarm indicators after the Alarm Pause button or [Alarm Reset] soft key is pressed. The technical alarms are classified into three categories for easy clarification:

■ Technical alarms are cleared.

All alarm indications are cleared after the Alarm Pause button or [Alarm Reset] soft key is pressed. After the equipment restores the normal alarm status, it can give alarm indications correctly in case these alarms are triggered again.

■ Technical alarms are changed to the prompt messages.

The alarm lamp flashing and alarm tones are cleared and the alarm messages change to prompt messages after the Alarm Pause button or [Alarm Reset] soft key is pressed. After the equipment restores the normal alarm status, it can give alarm indications correctly in case these alarms are triggered again.

■ The alarm is silenced and a √ appears before the alarm message.

The alarm tones are cleared but the alarm lamp flashing and alarm messages remain after the Alarm Pause button or [Alarm Reset] soft key is pressed. After the equipment restores the normal alarm status, all the alarm indications will continue if the alarm conditions still present.

4.12 Testing Alarms

hen the equipment starts up, a selftest is performed. In this case the alarm lamp is lit in yellow and red

W respectively, and the equipment 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 SpO2 or CO2) or use a simulator. Adjust alarm limits and check that appropriate alarm behaviour is observed.

Defibrillator/Monitor Operator’s Manual 4 - 7

4.13 Actions When an Alarm Occurs

When an alarm occurs, observe the following steps and take proper actions:

1. Check the patient’s condition.

2. Confirm the alarming parameter or alarm category.

3. Identify the alarm source.

4. Take proper action to eliminate the alarm condition.

5. Make sure the alarm condition is corrected.

For actions taken with regard to specific alarms, refer to EAlarm Messages.

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5 Monitoring ECG

WARNING

CAUTION

NOTE

5.1 ECG Introduction

The electrocardiogram (ECG) measures the electrical activity of the heart and displays it as waveforms and numerics. The equipment enables ECG monitoring through 3-lead ECG sets, 5-lead ECG sets, external paddles and electrode pads. If both ECG sets and external paddles/electrode pads are connected, the configured ECG waveforms are displayed in the waveform area.

ECG monitoring is intended for adult, pediatric and neonatal patients.

5.2 ECG Safety Information

• ECG monitoring is not suitable for direct cardiac application.

• 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.

• When monitoring a patient implanted with a pacemaker, be sure to select correct paced status.

Otherwise, the pace pulses may be counted in the case of cardiac arrest or some arrhythmias. Do not completely rely on the heart rate reading or the heart rate alarms. Always keep paced patients under close surveillance.

• PACEMAKER PATIENTS – 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.

• Interference from a non-grounded instrument near the patient and electrosurgery interference can

cause problems with the waveform.

• When connecting electrodes and/or patient cables, make sure that the connectors never come into

contact with other conductive parts, or with earth. Particularly make sure that all of the ECG electrodes are attached to the patient.

• If selected lead cannot provide valid ECG signals, a dash line is shown in the ECG waveform area.

• Avoid using external paddles for ECG monitoring if possible.

• Use the same type of ECG electrodes when monitoring ECG through ECG lead set.

Defibrillator/Monitor Operator’s Manual 5 - 1

5.3 Monitoring View

A typical screen in the Monitor mode is shown below.

You can enter the Monitor mode by switching the Mode Select knob to Monitor. When operating in the Monitor mode, the equipment displays up to two ECG waveforms, the heart rate reading, other available parameter values and active alarm settings.

5.4 Preparing for ECG Monitoring and Measurement

5.4.1 Preparing the Patient Skin

Proper skin preparation is necessary for good signal quality at the electrode, as the skin is a poor conductor of electricity. To properly prepare the skin, choose flat areas and then follow this procedure:

1. Shave hair from skin at chosen sites.

2. Gently rub skin surface at application sites to remove dead skin cells.

3. Thoroughly clean the sites with mild soap and water. We do not recommend using ether or pure alcohol, because this dries the skin and increases the resistance.

4. Dry the skin completely before applying the electrodes.

5.4.2 ECG Monitoring with Electrodes

5.4.2.1 Applying Electrodes

1. Attach the clips or snaps to the electrodes before placing them.

2. Place the electrodes on the patient.

3. Attach the lead wires to the ECG trunk cable and then plug the trunk cable into the ECG connector.

4. Switch the Mode Select knob to Monitor.

5 - 2 Defibrillator/Monitor Operator’s Manual

5.4.2.2 ECG Electrode Placements

3-Lead Placement

The following is a typical AHA electrode placement for a 3-lead ECG set:

■ 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.

5-Lead Placement

The following is a typical AHA electrode placement for a 5-lead ECG set:

■ 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 left posterior axillary line in the fifth intercostal space.

Electrode Placement for Surgical Patients

The surgical site should be taken into consideration when placing electrodes on a surgical patient, e.g. for openchest 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.

Defibrillator/Monitor Operator’s Manual 5 - 3

WARNING

• When using electrosurgical units (ESU), place ECG electrodes between the ESU and its grounding

NOTE

plate to prevent unwanted burns. Never entangle ESU cable and 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.

5.4.3 ECG Measurement with Electrode Pads

1. Apply the electrode pads to the patient as indicated on pads package.

or adult patients, use the anterior-lateral placement:

■ F

◆ Place the red (sternum) pad on the patient’s upper right torso, lateral to the sternum and below

the clavicle.

◆ Place the blue (apex) pad to the patient’s left nipple in the midaxillary line, with the center of the

electrode in the midaxillary line.

■ For pediatric patients, use the anterior-posterior placement:

◆ Place the blue (apex) pad in the center of the patient’s chest between the nipples.

◆ Place the red (sternum) pad in the center of the patient’s back.

For adult Patients (anterior-lateral placement) For pediatric patients (anterior-posterior placement)

2. Connect the electrode pads to the pads cable.

3. Connect the electrode pads cable with the equipment if not connected.

• Anterior - lateral placement for adult patients, and anterior-posterior placement for pediatric

patients are the only placement that can be used for ECG monitoring with electrode pads.

5 - 4 Defibrillator/Monitor Operator’s Manual

5.4.4 ECG Measurement with External Paddles

NOTE

WARNING

Sternum

paddle

Apex paddle

1. Connect the paddles cable with the equipment if not connected.

2. Apply conductive gel to paddle electrodes.

3. Remove the paddle set from the paddle tray by grasping the handles and pulling them straight up.

4. Apply the external paddles to the patient by using anterior-lateral placement.

◆ Place the sternum paddle on the patient’s upper right torso, lateral to the sternum and below the clavicle.

◆ Place the apex paddle to the patient’s left nipple in the midaxillary line, with the center of the electrode in the midaxillary line.

• Anterior - lateral placement is the only placement that can be used for ECG monitoring with external

paddles.

5.4.5 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 [Ye s ]. The pace pulse markers “?” are shown on the ECG wave when the patient has a paced signal.

To change the paced status, choose either of the following ways:

■ Press the Main Menu button and select [Patient Demographics >>], set [Paced].

■ Select the ECG parameter area and select [Others >>], set [Paced].

• For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the equipment could

mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. Do not rely entirely on rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close surveillance.

• For non-paced patients, you must set [Paced] to [No]. If it is incorrectly set to [Yes], the equipment

may be unable to detect premature ventricular beats (including PVCs).

• 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.

Defibrillator/Monitor Operator’s Manual 5 - 5

5.5 ECG Display

(1) (2) (3) (4)

(5)

(6)

(7)

The figure below shows the ECG monitoring view in 3-lead mode. It is for reference only. Your display may be configured to look slightly different.

(1) ECG lead label (2) ECG waveform gain

(3) ECG filter mode (4) Notch filter status

(5) HR alarm limits (6) HR unit

(7) PVCs values: it is shown only when arrhythmia analysis is switched on. When external paddles or electrode pads are used for ECG monitoring, the PVCs values is

shown as “---”.

5.6 Changing ECG Settings

5.6.1 Selecting the Lead Type

1. Select the ECG parameter area to enter the [ECG Setup] menu.

2. Select [Lead Set] and toggle between [3-Lead] and [5-Lead].

You can also set lead type by selecting [ECG Setup] through the Configuration Main menu. The settings changed in the Configuration Main menu will be saved when the equipment is turned off.

5.6.2 Choosing the ECG Standard

1. Press the Main Menu button on the front panel, and select [Others >>] → [Configuration >>] → enter the required password.

2. Select [ECG Setup] → [ECG Standard], and then select [AHA] or [IEC] according to the standard that is applied to your hospital.

5.6.3 Selecting the Lead of Displayed ECG Waveform

5 - 6 Defibrillator/Monitor Operator’s Manual

To compute heart rate and to detect and analyze arrhythmia more accurately, you can choose a lead of best quality signals as the HR calculation lead.

1. Press the Lead Select button on the front panel, or rotate the Navigation knob to move the cursor on the ECG lead label and press the Navigation knob.

2. Rotate the Navigation knob until you find the desired item, and then press the Navigation knob to confirm the selection.

The 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.

NOTE

5.6.4 Setting the ECG Waveform Layout

1. Select the ECG parameter area to enter the [ECG Setup] menu.

2. Select [Cascade] and toggle between [On] and [Off].

5.6.5 Changing ECG Waveform Size

If the ECG waveform is too small or clipped, you change its size by using the Navigation knob.

1. Rotate the Navigation knob to move the cursor on the ECG waveform gain.

2. Press the Navigation knob to highlight it.

3. Rotate the Navigation knob until you find the desired item, and then press the knob to confirm the selection.

5.6.6 Changing ECG Waveform Speed

1. Select the ECG parameter area to enter the [ECG Setup] menu.

2. Select [Sweep], and then choose an appropriate value. The faster the wave sweeps, the wider the wave is.

You can also set [Sweep] by selecting [ECG Setup] from the Configuration Main menu.

5.6.7 Setting the ECG Filter

■ When monitoring ECG through 3/5- lead set, filter mode is displayed above the first ECG waveform. The

available filter mode settings are [Monitor], [Therapy], and [Diagnostic].

■ When monitoring ECG through external paddles/electrode pads, filter mode is always [Therapy] and can

not be changed.

To set the ECG filter mode:

1. Rotate the Navigation knob to move the cursor on the ECG filter mode.

2. Press the Navigation knob to highlight it.

3. Rotate the Navigation knob until you find the desired item, and then press the knob to confirm the selection.

• For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the system may

mistake an internal pace pulse for a QRS or fail to alarm when the pacer is broken.

5.6.8 Switching On or Off the Notch Filter

The notch filter removes the AC line noise. Switching on the notch filter is recommended when there is interference with the waveform.

■ When the ECG filter mode is set to [Monitor] or [Therapy], [Notch Filter] is always [On].

■ When the ECG filter mode is set to [Diagnostic], [Notch Filter] can be switched on or off as required.

Set notch frequency according to the electric power frequency of your country. To switch on or off notch filter:

1. Select the ECG parameter area to enter the [ECG Setup] menu.

2. Select [Others >>] → [Notch Filter], and toggle between [On] and [Off].

You can also set the power frequency of notch filter by selecting [ECG Setup] through the Configuration Main menu.

• The setting of [Notch Filter] will not be changed by restoring to factory default settings nor shutting

down the system.

Defibrillator/Monitor Operator’s Manual 5 - 7

5.6.9 Adjusting the QRS Volume

WARNING

In the case that ECG alarm is switched on, or both ECG alarm and PR alarm are switched off, heartbeat tone is issued.

To adjust the heartbeat volume:

1. Select the ECG parameter area to enter the [ECG Setup] menu.

2. Select [Others >>] → [QRS Volume]. The heartbeat volume can be set between 0 and 10, in which 0 means off, and 10 is the maximum volume.

You can also change the QRS volume by selecting [ECG Setup] through the Configuration Main menu.

When a valid SpO value.

value exists, the system will adjust the pitch of the heartbeat tone according to the SpO2

5.7 Arrhythmia Analysis

Arrhythmia analysis provides information about your patient’s condition, including heart rate and arrhythmia alarms.

• Arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to

detect 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.

• Atrial fibrillation (Afib) detection function is not intended for pediatric and neonatal patients.

• Arrhythmia analysis is not intended for neonatal patients.

5.7.1 Understanding the Arrhythmia Events

Arrhythmia event Description Category

Asystole No QRS complex for 4 consecutive seconds (in absence of ventricular

fibrillation or chaotic signals).

V-Fib/V-Tach A fibrillatory wave for 4 consecutive seconds.

A dominant rhythm of adjacent Vs and a HR > the V-Tach Heart Rate Limit

V-Tach The consecutive PVCs > Vtac PVCs limit, and the HR > the Vtac HR limit.

Vent. Brady The consecutive PVCs ≥ the Vbrd threshold and the ventricular HR < the

Vbrd Rate threshold.

Extreme Tachy The heart rate is greater than the extreme tachycardia limit.

Extreme Brady The heart rate is less than the extreme bradycardia limit.

Lethal arrhythmia

5 - 8 Defibrillator/Monitor Operator’s Manual

Arrhythmia event Description Category

PVCs/min PVCs/min exceeds high limit Nonlethal

PNP** No pace pulse detected for 1.75 x average R-to-R intervals following a

QRS complex (for paced patients only).

arrhythmia

PNC** No QRS complex detected for 300 milliseconds following a pace pulse (for

PVC One PVC detected in normal heartbeats

Couplet Paired PVCs are detected.

VT>2 More than 2 consecutive PVCs within the last minute.

Bigeminy A dominant rhythm of N, V,N, V, N, V.

Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V.

R ON T R on T detected in normal heartbeats.

Missed Beat* No beat detected for 1.75x average R-R interval for HR <120, or No beat

Brady The average heart rate is less than 60 bpm.

Tachy The average heart rate is greater than 100 bpm.

Vent Rhythm The consecutive PVCs > the Vbrd PVCs limit, and the HR is between Vbrd

Multif. PVCs Multiform PVCs detected in Multif. PVC's Window (which is adjustable).

Nonsus. Vtac The consecutive PVCs < the Vtac PVCs limit but > 2, and HR > the Vtac

Pause* No QRS detected within the set time threshold of pause.

paced patients only).

for 1 second with HR >120 (for non-paced patients only), or No beat detected for more than the set pause threshold.

Rate limit and the Vtac Rate limit.

Rate limit.

Irr. Rhythm Consistently irregular rhythm.

A-Fib (for adult only) P wave is absent and normal beat RR intervals are irregular.

*: indicates that this arrhythmia alarm is not presented when [Paced] is set to [Ye s ]. **: indicates that this arrhythmia alarm is not presented when [Paced] is set to [No].

■ When electrode pads are used for ECG monitoring, the equipment provides only 4 arrhythmia alarms,

including asystole, ventricular fibrillation/ventricular tachycardia, PNP, and PNC.

■ When external paddles are used, the equipment provides only 3 arrhythmia alarms, including ventricular

fibrillation/ventricular tachycardia, PNP, and PNC.

5.7.2 Switching Arrhythmia Analysis On and Off

To switch arrhythmia analysis on or off:

1. Select the ECG parameter area to enter the [ECG Setup] menu,.

2. Select [Arrhythmia >>] → [Arrhythmia], and toggle between [On] and [Off].

You can also swtich on or off [Arrhythmia] by selecting [ECG Setup] from the Configuration Main menu.

5.7.3 Changing Arrhythmia Alarm Settings

To change arrhythmia alarm settings:

1. Select the ECG parameter area to enter the [ECG Setup] menu

2. Select [Arrhythmia >>] → [Arrh. Alarm >>], where you can set alarm switch, alarm level and alarm record switch for all the arrhythmia events.

You can also set [ARR Alm Lev] by selecting [ECG Setup] from the Configuration Main menu.

Defibrillator/Monitor Operator’s Manual 5 - 9

NOTE

• The alarm level for asystole, ventricular fibrillation, ventricular tachycardia, ventricular bradycardia,

NOTE

extreme bradycardia, and extreme tachycardia alarms is always high and unchangeable. These alarms are always on. As long as the alarm condition occurs, corresponding alarm will be triggered whether arrhythmia analysis is switched on or off.

5.7.4 Changing Arrhythmia Threshold Settings

To change arrhythmia threshold settings:

1. Select the ECG parameter area to enter the [ECG Setup] menu.

2. Select [Arrhythmia >>] → [Arrh. Threshold >>].

In case an arrhythmia violates its threshold, an alarm will be triggered. The setting of [Asystole Delay] is relevant to ARR relearning. When HR is less than 30 bpm, it is recommended to set [Asystole Delay] to 10 seconds.

Arrh. Event Range Default Step Unit

PVCs High 1 to 10 10 1 /

Asystole Delay 3 to 10 5 1 s

Tachy 60 to 300 Adult: 120

Pediatric: 160

Brady 15 to 120 Adult: 50

Pediatric: 75

Extreme Tachy 60 to 300 Adult: 160

Pediatric: 180

Extreme Brady 15 to 120 Adult: 35

Pediatric: 50

Multif. PVCs Window 3 to 31 15 1 Beats

V-Tach Rate 100 to 200 130 5 bpm

V-Tach PVCs 3 to 99 6 1 Beats

Pause Time 1.5, 2.0, 2.5 2.0 / s

Vbrd Rate 15 to 60 40 5 bpm

Vbrd PVCs 3 to 99 5 1 Beats

You can also set arrhythmia threshold by selecting [ECG Setup] from the Configuration Main menu.

5.7.5 Initiating Arrhythmia Relearning Manually

Normally arrhythmia relearning allows the equipment to learn new ECG patterns to correct arrhythmia alarms and heart rate value. We suggest you manually initiate arrhythmia relearning when you suspect the result of arrhythmia analysis.

To initiate relearning manually:

5 bpm

1. Select the ECG parameter area to enter the [ECG Setup]menu

2. Select [Arrhythmia >>] → [Relearn Arrh.].

3. When the equipment is learning, the message “Learning ECG” is displayed in the technical alarm area.

• Arrhythmia relearning in the case of ventricular tachycardia may affect correct arrhythmia alarm.

5 - 10 Defibrillator/Monitor Operator’s Manual

5.7.6 Automatic Arrhythmia Relearn

NOTE

Arrhythmia relearning is initiated automatically whenever:

■ The ECG lead or lead label is changed

■ The ECG lead is re-connected

■ Patient category is changed

■ The paced status is changed

■ Arrhythmia analysis is switched on

■ [Stop Calibrating] is selected after ECG calibration is completed.

5.8 Calibrating ECG

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 can perform ECG calibration to check if the ECG wave amplitude is in normal range.

1. Rotate the Navigation knob to move the cursor on the ECG filter mode.

2. Press the Navigation knob to highlight it.

3. Rotate the Navigation knob until you find [Diagnostic], and then press the Navigation knob to confirm the selection.

4. Select the ECG parameter area to enter the [ECG Setup] menu.

5. Select [Others >>] → [Calibrate]. In this case, a square wave appears on the screen and the message “Calibrating ECG” is displayed.

6. Compare the amplitude of the square wave with the 1mV wave scale. The difference should be within 5%.

7. After the calibration is completed, select [Stop Calibrating].

You can print out the waveform and wave scale and then measure the difference between them if necessary. If the difference exceeds 5%, contact your service personnel.

5.9 ECG Troubleshooting

This section lists the problems that might occur. If you encounter problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists after you have taken corrective actions, contact your service personnel.

• For the physiological and technical alarm messages, refer to EAlarm Messages.

Problem Corrective Actions

Noisy ECG traces 1. Check that electrodes are not detached or dry. Replace with fresh and

Excessive electrosurgical Interference Use ESU-proof ECG cables. For details, refer to 28.1ECG Accessories.

Muscle Noise Inadequate skin preparation, tremors, tense subject, and/or poor electrode

moist electrodes if necessary.

2. Check that leadwires are not defective. Replace leadwires if necessary.

3. Check that patient cable or leadwires are routed too close to other electrical devices. Move the patient cable or leadwires away from electrical devices.

placement.

1. Perform skin preparation again and re-place the electrodes. For details, refer to 5.4Preparing for ECG Monitoring and Measurement.

2. Apply fresh, moist electrodes. Avoid muscular areas.

Defibrillator/Monitor Operator’s Manual 5 - 11

Problem Corrective Actions

Intermittent Signal 1. Check that cables are properly connected.

2. Check that electrodes are not detached or dry. Perform skin preparation

again as described in5.4Preparing for ECG Monitoring and Measurement.

3. Check that the patient cable or leadwires are not damaged. Change them if necessary.

Excessive alarms: heart rate, lead fault 1. Check that electrodes are not dry. Perform skin preparation again and

replace the electrodes. For details, refer to 5.4Preparing for ECG

Monitoring and Measurement.

2. Check for excessive patient movement or muscle tremor. Reposition the electrodes. Replace with fresh and moist electrodes if necessary.

Low Amplitude ECG Signal 1. Check that the ECG gain is not set too low. Adjust the gain as required.

For details, refer to 5.6.5Changing ECG Waveform Size.

2. Perform skin preparation again and re-place the electrodes. For more information, refer to 5.4Preparing for ECG Monitoring and Measurement.

3. Check electrode application sites. Avoid bone or muscular area.

4. Check that electrodes are not dry or used for a prolonged time. Replace with fresh and moist electrodes if necessary.

No ECG Waveform 1. Check that the ECG gain is not set too low. Adjust the gain as required.

For details, refer to 5.6.5Changing ECG Waveform Size.

2. Check that the leadwires and patient cables are properly connected. Change cable and lead wires.

3. Check that the patient cable or leadwires are not damaged. Change them if necessary.

Base Line Wander 1. Check for excessive patient movement or muscle tremor. Secure

leadwires and cable.

2. Check that electrodes are not detached or dry and replace with fresh and moist electrodes if necessary. For details, refer to 5.4Preparing for ECG Monitoring and Measurement.

3. Check for ECG filter setting. Set ECG Filter mode to [Monitor].

5 - 12 Defibrillator/Monitor Operator’s Manual

6 AED

DANGER

WARNING

CAUTION

NOTE

6.1 AED Introduction

This chapter describes how to operate the equipment in the AED Mode. While operating in the AED Mode, the equipment analyzes the patient’s ECG waveforms and guides you through the defibrillation process.

The equipment starts analyzing the patient’s heart rhythm immediately after entering the AED mode. When a shockable rhythm is detected, the equipment gives a prompt and automatically starts charging. If a shockable rhythm is not detected, a “No Shock Advised!” prompt is given. Smart defibrillation analysis goes through automated external defibrillation until the equipment enters CPR or abnormal electrode pads connection occurs.

While operating in the AED Mode, ECG signals acquired through electrode pads are displayed. Besides ECG, you can also select to monitor parameters from SpO measurements are indefinitely paused and entry of patient information is disabled. Additionally, the Lead Select, Alarm Pause, NIBP Start/Stop and Main Menu buttons are inactive.

6.2 AED Safety Information

• Defibrillation current can cause operator or bystander severe injury or even death. Never touch the

patient or any metal objects connected to the patient (including the bed or gurney) during defibrillation.

• Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive

fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current.

• Do not allow electrode pads to touch each other or to touch other ECG monitoring electrodes, lead

wires, dressings, etc. Contact with metal objects may cause electrical arcing and patient skin burns during defibrillation and may divert current away from the heart.

, NIBP and CO2. Previously set alarms and scheduled

• During defibrillation, air pockets between the skin and electrode pads can cause patient skin burns.

To help prevent air pockets, make sure electrode pads are completely adhered to the skin.

• Do not use dried-out electrode pads.

• Aggressive handling of electrode pads in storage or prior to use can damage the electrode pads.

Discard the electrode pads if they become damaged.

• For patients with implantable pacemaker, the sensitivity and specificity of AED algorithm may be

impaired.

• Successful resuscitation is dependent on many variables specific to the patient’s physiological state

and the circumstances surrounding the patient event. Failure to have a successful patient outcome is not a reliable indicator of equipment performance. The presence or absence of a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or equipment performance.

Defibrillator/Monitor Operator’s Manual 6 - 1

6.3 AED View

(1)

(3)

(5) (6)

(2)

(7)

(4)

A typical screen in the AED Mode is shown below.

(1) Operating mode

(2) AED prompt message

(3) ECG parameter and waveform area:

(4) Contact impedance indicator (configurable)

This area displays HR numeric and one ECG waveform acquired from the electrode pads.

It indicates the impedance between the patient and electrode pads. For details, refer to

7.7Contact Impedance Indicator.

(5) Shock counter

(6) Selected energy

(7) Auxiliary parameter and/or waveform area

6.4 AED Procedure

Confirm that the patient is unresponsive, not breathing or not breathing normally. Then:

1. Prepare the patient and apply the electrode pads to the patient. For details, refer to 5.4.1Preparing the Patient Skin and 5.4.3ECG Measurement with Electrode Pads.

2. Connect the electrode pads with pads cable, and then plug the pads cable into the therapy port.

Switch the Mode Select knob to AED. When the equipment enters the AED mode, it checks to see if the electrode pads and pads cable are properly connected. If not, the message “Connect Pads Cable” or “Apply Pads” will appear in the AED information area until corrective action has been taken.

3. Use the Navigation knob to switch the patient category between [Adu] and [Ped], if necessary. The default energy level is automatically changed.

◆ For defibrillation of adult patients, recommended energy level for the first shock is 200 J.

◆ For defibrillation of pediatric patients, recommended energy level for the first shock is 50 J.

4. Follow the screen and voice prompts.

Once an ECG is detected through the electrode pads, the equipment automatically analyzes the patient’s heart rhythm and warns you not to touch the patient. If a shockable rhythm is detected, the equipment charges automatically.

You can switch on or off the voice prompt by selecting [AED Setup] from the Configuration Main menu or adjust the volume of the voice prompts by pressing the voice volume soft key.

5. Press the Shock button, if prompted.

Once charging is completed, the equipment gives prompt “Do Not Touch Patient! Press Shock Button”. Make sure no one is touching the patient, bed or any equipment connected to the patient. Call out clearly and loudly “Stay Clear”. Then press the Shock button on the front panel to deliver a shock to the patient.

This area displays parameters from SpO parameter by selecting [Manual Defib Setup] from the Configuration Main menu.

, NIBP or CO

You can define the auxiliary

6 - 2 Defibrillator/Monitor Operator’s Manual

Delivery of the shock is confirmed by the voice and screen prompt “Shock Delivered” and the shock

NOTE

counter on the display is updated to reflect the number of shocks given. When the configured [Shock Series] is greater than one, the equipment resumes analyzing the patient’s rhythm after the shock is

delivered to see if the shock was successful. Voice and text prompts continue to guide you through additional shocks, the energy level of shock followed the first shock is automatically changed to the default level.

• For defibrillation of pediatric patients under 8 years, pediatric electrode pads should be used.

• If pediatric electrode pads are not available, the adult electrode pads may be used instead, and set

the patient category to [Ped].

• Motion artifact may delay analysis or affect the ECG signal resulting in an inappropriate shock or no

shock advised message. Keep the patient still during ECG rhythm analysis.

• The Shock button must be pressed to deliver a shock. The equipment will not automatically deliver a

shock.

• Impedance is the resistance between the electrode pads/external paddles that the defibrillator must

overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin. If the “Impedance too high. Shock not delivered” message appears, make sure that the patient’s skin has been dried and that any chest hair has been clipped. If the message persists, change the electrode pads and/or the pads cable.

6.5 Shock Advised

If a shockable rhythm is detected, the equipment automatically charges to the pre-configured energy level. A charging tone is sounded, and the Shock button flashes when the equipment is fully charged.

Heart rhythm analysis continues while the equipment charges. If a rhythm change is detected before the shock is delivered and a shock is no longer appropriate, the stored energy is removed internally.

Once you are prompted “Do Not Touch Patient! Press Shock Button”, if you do not do so within the configured Auto Disarm time interval, the equipment disarms itself and resumes analyzing.

When the equipment is being charged or have been fully charged, you can remove the charged energy at any time by pressing the [Pause for CPR] soft key.

Defibrillator/Monitor Operator’s Manual 6 - 3

6.6 No Shock Advised (NSA)

NOTE

If a shockable rhythm is not detected, the equipment will tell you “No Shock Advised!”.

■ If the [NSA Action] is set to [CPR]

The equipment enters the CPR status and you will see and hear “No Shock Advised! Paused, If Needed, Begin CPR.” The remaining pause time is displayed as shown below.

You can set [CPR Time] to define the pause period by selecting [AED Setup] from the Configuration Main menu. Analysis resumes at the completion of the pause period or when you press the [Resume Analyzing] soft key in the CPR status.

■ If the [NSA Action] is set to [Monitor]

The equipment continues to monitor the ECG and automatically resumes analysis if a potentially shockable rhythm is detected. You will hear “No Shock Advised! If needed, press “Pause for CPR”. The message “No Shock Advised!” and “Monitoring” are shown circularly in the AED information area.

You c an se t [Voice Prompt Interval] to define the frequency of prompts by selecting [AED Setup] from the Configuration Main menu. You may press the [Pause for CPR] soft key to suspend monitoring and administer CPR.

6.7 CPR

If [Initial CPR Time] is not configured as [Off], the equipment enters initial CPR if the AED mode is entered. You can set [Initial CPR Time] to an appropriate time or switch it off by selecting [AED Setup] from the Configuration Main menu.

After the shock series, ECG analysis pauses and the equipment enters the CPR status. Analysis resumes at the completion of the pause period or when you press the [Resume Analyzing] soft key in the CPR status.

In current shock series, the equipment enters the CPR status if you press the [Pause for CPR] soft key after a shock is delivered. You can set [CPR Time] to define the pause period by selecting [AED Setup] from the Configuration Main menu.

• You can start analyzing patient’s heart rhythm again at any time by pressing the [Resume Analyzing]

soft key in the CPR status.

6.7.1 CPR Metronome

The equipment provides a CPR metronome feature that can be used to encourage rescuers to perform chest compression and ventilation at AHA/ERC recommended rate.

When activated, the metronome sounds 110 times per minute and give voice prompts to indicate you to perform ventilation at configured compression/ventilation rate.

To switch on or off CPR metronome:

1. Switch the Mode Select knob to Monitor, Manual Defib or Pacer.

2. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → enter the required password.

3. Select [AED Setup] → [CPR Metronome], and toggle between [On] and [Off].

The CPR metronome is activated by default. You can set the compression/ventilation rate by selecting [CPR Mode] through the Configuration Main menu. The default rate is 30:2.

6 - 4 Defibrillator/Monitor Operator’s Manual

WARNING

• The CPR metronome sounds do not indicate information regarding the patient’s condition. Because

NOTE

patient status can change in a short time, the patient should be assessed at all times. Do not perform CPR on a patient who is responsive or is breathing normally.

• The CPR metronome is deactivated when [Voice Prompts] in the [AED Setup] menu is configured off

through the Configuration Main menu.

• The volume of CPR metronome is affected by [Voice Volume] in the [AED Setup] menu configured

through the Configuration Main menu.

6.8 AED Sound Recording

The equipment provides a sound recording function that can record the voice information during AED therapy. The sound recording function can be configured on or off.

To switch on or off the sounding recording:

1. Switch the Mode Select knob to Monitor, Manual Defib or Pacer.

2. Press the Main Menu button on the front panel, and then select → [Others >>] → [Configuration >>] → enter the required password.

3. Select [AED Setup] → [Voice Recording], and toggle between [On] and [Off].

is shown at the top right corner of the AED information area if the sounding recording function is

enabled.

The equipment can store up to 180 minutes, maximum 60 minutes for one patient, of sound recording.

6.9 AED Setup

1. Switch the Mode Select knob to Monitor, Manual Defib or Pacer.

2. Press the Main Menu button on the front panel, and then select → [Others >>] → [Configuration >>] → enter the required password.

3. Select [AED Setup] , and then change AED settings as desired.

For details, refer to 21.6.3AED Setup Menu.

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7 Manual Defibrillation

DANGER

WARNING

7.1 Manual Defibrillation Introduction

This chapter explains how to prepare for and perform asynchronous defibrillation and synchronized cardioversion using electrode pads, external paddles and internal paddles.

In the Manual Defib Mode, you must assess the ECG waveforms, decide if defibrillation or cardioversion is indicated, select appropriate energy setting, charge the equipment, and deliver the shock. Text messages and a contact impedance indicator on the screen provide relevant information to guide your throughout the defibrillation process.

While operating manual defibrillation, besides ECG, you can select to monitor parameters from SpO CO2. Alarms are turned off automatically when you enter the Manual Defib mode. Pressing the Alarm Pause button on the front panel of the equipment can turn on the alarms.

7.2 Manual Defibrillation Safety Information

• Defibrillation current can cause operator or bystander severe injury or even death. Never touch the

patient or any metal objects connected to the patient (including the bed or gurney) during defibrillation.

• Avoid contact between parts of the patient’s body such as exposed skin of head or limbs, conductive

fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current.

• Do not allow electrode pads and paddles to touch each other or to touch other ECG monitoring

electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and patient skin burns during defibrillation and may divert current away from the heart.

• During manual defibrillation, make sure your hands are dry and free from conductive gel to avoid

shock hazard.

• Use care when operating this equipment close to oxygen sources (such as bag-valve-mask devices or

ventilator tubing). Turn off gas source or move source away from patient during defibrillation. This can cause an explosion hazard.

, NIBP and

• During synchronized cardioversion, if monitoring patient’s ECG through external paddles, artifact

introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock.

• Do not use conductive liquid. Use only conductive gel specified by the equipment manufacturer.

• If external paddles are used for defibrillation, apply the external paddles tightly and evenly to the

patient’s chest to ensure good skin contact.

• Never apply the paddles to human body to verify paddle connection.

• Clinicians must select an appropriate energy level for defibrillation of pediatric patients.

• Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage

could occur.

Defibrillator/Monitor Operator’s Manual 7 - 1

CAUTION

• Use of Manual Defib mode may be password protected. Make sure the operator knows and

NOTE

(1)

(3)

(5)

(6)

(2)

(7)

(4)

remembers the password as defined in Configuration. Failure to enter correct password will prevent the delivery of manual defibrillation therapy.

• Clear the conductive gel from the external paddles at the completion of the therapy to prevent the

paddles from being corroded.

• Prior to using the equipment, disconnect the patient from all equipment that is not defibrillator-

protected.

• Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment damage

could occur.

• Impedance is the resistance between the electrode pads/external paddles that the defibrillator must

overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin. If the “Impedance Too High, Shock Not Delivered” message appears, make sure that the patient’s skin has been dried and that any chest hair has been clipped. If the message persists, change the electrode pads and/or the pads cable.

• Alarms are switched off automatically and the “Alarm Off” message is displayed when the

equipment enters the asynchronous defibrillation mode. Alarms remain off until toggled on by pressing the Alarm Pause button, the Sync mode, the Monitor mode or Pacer mode is entered.

• Successful resuscitation is dependent on many variables specific to the patient’s physiological state

7.3 Manual Defibrillation View

A typical screen in the Manual Defib Mode is shown below.

(1) Operating mode

(2) D

(3) ECG parameter and waveform area

(4) Contact impedance indicator (configurable)

efibrillation prompt message

This area displays HR numeric and one ECG waveform acquired from the electrode pads, external paddles or internal paddles.

It indicates the impedance between the patient and electrode pads or external paddles. For details, refer to 7.7Contact Impedance Indicator.

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WARNING

(5) Selected energy

Do not touch this surface and the part below.

(6)

hock counter

(7) Auxiliary parameter and/or waveform area:

This area displays parameters from SpO parameter by selecting [Manual Defib Setup] from the Configuration Main menu.

7.4 Manual Defibrillation Procedure

1. Remove clothing from the patient’s chest. Wipe moisture from the patient’s chest and, if necessary, clip or shave excessive chest hair.

2. Plug the therapy cable into the therapy port. Push until you hear it clicks into place.

3. Prepare the patient and apply the electrode pads/external paddles.

◆ If electrode pads are used, apply electrode pads to the patient as described in 5.4.3ECG

MonitoringMeasurement with Paddles/Electrode Pads.

◆ If external paddles are used, remove the paddle set from the paddle tray by grasping the handles and

pulling them straight up. Apply conductive gel to the electrode surface of each paddle. Place the external paddles as described in 5.4.4ECG Measurement with External Paddles.

, NIBP or CO

You can define the auxiliary

• Hold only the insulating parts of the paddle handles to avoid shock hazard during charging or shock

delivery.

Switch the Mode Select knob to Manual Defib. You can define [Manual Therapy Access] by selecting [Manual Defib Setup] from the Configuration Main menu.

4. Select energy

You can use the Navigation knob to switch the patient category between [Adu], [Ped] and [Neo], if necessary. The default energy level is automatically changed.

◆ For defibrillation of adult patients, recommended energy level for the first shock is 200 J.

◆ For defibrillation of pediatric patients, recommended energy level for the first shock is 50 J.

Defibrillator/Monitor Operator’s Manual 7 - 3

The current energy selection is shown in the defibrillation information area as shown below.

NOTE

You can also select the desired energy level by the adjusting the Energy Select buttons on the front panel or on external paddles if external paddles are used.

5. Charge

Press the Charge button on the front panel. If external paddles are used, the Charge button on the paddles may be used instead. As the equipment charges, a progress bar is shown in the defibrillation information area. A charging tone sounds until desired energy level is reached, when you will hear a charge done tone.

If you have to increase or decrease the selected energy during charging or after charging is completed, adjust the Energy Select button to select the desired energy level as explained above. Then press the Charge button again to restart charging.

To remove the energy, press the [Disarm] soft key. If the Shock button is not pressed within the specified time period, the equipment disarms automatically. You can set [Time to Auto Disarm] to define the time period by selecting [Manual Defib Setup] from the Configuration Main menu.

6. Shock

Confirm that a shock is still indicated and that the equipment has charged to the selected energy level. Make sure no one is touching the patient, bed or any equipment connected to the patient. Call out clearly and loudly “Stay Clear”.

◆ If electrode pads are used, press the flashing Shock button on the front panel to deliver a shock to the patient.

◆ If external paddles are used, simultaneously press the Shock buttons located on the paddles to deliver a shock to the patient.

• Defibrillation is always performed through external paddles or electrode pads. However, during

defibrillation you may choose to monitor the ECG using an alternate ECG source (3- or 5-lead monitoring electrodes). If an alternate ECG source is connected, any available lead may be displayed.

• When external paddles are used, the Shock button on the front panel is disabled.

• For defibrillation of pediatric patients, you can use the default energy level, or adjust the energy

level to 2-4 J/kg for the first shock and 4 J/kg for additional shocks followed the first shock.

• For defibrillation of pediatric patients under 8 years, pediatric electrode pads should be used.

• If pediatric electrode pads are not available, the adult electrode pads may be used instead, and set

the patient category to [Ped].

• For defibrillation of neonatal patients, set the energy level according to the patient’s clinical

condition. The energy level for neonatal patient should be lower than the default setting.

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7.4.1 Using Pediatric Paddles

The external paddles provide both adult paddle electrodes and pediatric paddle electrodes included inside.

To use the pediatric paddles:

1. Press the latch buttons on the external paddles.

2. Pull forward the adult paddle electrodes to remove them.

For details on the defibrillation procedures, refer to 7.4Manual Defibrillation Procedure.

7.4.2 Using Internal Paddles

To defibrillate using internal paddles:

1. Switch the Mode Select knob to Manual Defib.

2. Select the appropriate paddle size.

3. Connect the internal paddles to the defibrillator by aligning the white pointer on the paddles cable with the arrow on the therapy port. Push until you hear its click into place.

4. Select energy by pressing the Energy Select button on the front panel.

Defibrillator/Monitor Operator’s Manual 7 - 5

5. Place the conductive surface of paddle electrodes against the patient's right atrium and left ventricle, as

NOTE

SYNC marker

R-wave marker

shown in the figure below:

6. Charge the defibrillator by pressing the Charge button on the front panel.

7. Make sure no one is touching the patient or anything connected to the patient.

8. Press the Shock button on the front panel.

• When internal paddles are used for defibrillation, the energy selection is automatically limited to 50

joules because of possible cardiac damage from higher energies.

• Sterilize the internal paddles before each use. Otherwise, severe infection may result.

• Clean the internal paddles after each use.

7.5 Synchronized Cardioversion

Synchronized cardioversion allows you to synchronize delivery of the defibrillator shock with the R-wave of the ECG. You may choose to perform synchronized cardioversion through electrode pads, external and internal paddles.

To use synchronized cardioversion, press the [Enter Sync] soft key in the asynchronous defibrillation mode. Then [SYNC] appears in the manual Defibrillation information area and a marker appears above each R-wave, see the figure below:

You can monitor ECG through electrode pads, or external paddles, or electrodes connected to a 3- or 5-lead ECG cable. Shock is delivered through either electrode pads or external paddles. For synchronized cardioversion, we recommend to acquire patient’s ECG through ECG lead set.

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CAUTION

• Using internal paddles for synchronized cardioversion requires that the patient’s ECG be acquired

NOTE

through a standard ECG cable. The patient’s ECG acquired through the internal paddles may be unreliable for synchronized cardioversion due to excessive noise or artifact causing inappropriate Rwave detection.

• When you access synchronized cardioversion, monitoring alarms is reactivated autonomously.

7.5.1 Performing Synchronized Cardioversion

1. Connect the therapy cable and apply the electrode pads or external paddles to the patient. If ECG set is used for ECG monitoring, connect the ECG trunk cable and apply the ECG electrodes to the patient. For detail, refer to 5.4Preparing for ECG Monitoring and Measurement.

2. Switch the Mode Select knob to Manual Defib, and press the [Enter Sync] soft key to activate the synchronized cardioversion function.

3. Select a lead. The selected lead should have a clear signal and a large QRS complex.

4. Verify that a white R-wave marker appears above each R-wave If the R-wave markers do not appear or do not coincide with the R-waves, for example above the T-waves, select another lead.

5. Verify that you access synchronized cardioversion, as indicated by the SYNC marker shown in the defibrillation information area.

6. Press the Energy Select button to select a desired energy level.

7. Press the Charge button on the equipment, if using external paddles, the Charge button located on the handle of Apex paddle.

8. Confirm that a shock is still indicated and that the equipment has charged to the selected energy level. Make sure no one is touching the patient, bed or any equipment connected to the patient. Call out loudly and clearly “Stay Clear”.

9. Press and hold the Shock button on the equipment or, if using external paddles, the Shock buttons on both paddles. The shock will be delivered when the next R-wave is detected.

• During synchronized cardioversion, it is important to continue to hold the shock button (or the

paddle’s Shock buttons) until the shock is delivered. The equipment shocks with the next detected R-wave.

7.5.2 Delivering Additional Synchronized Shocks

If additional synchronized shocks are indicated, perform the following steps:

1. Make sure the equipment is still in Sync mode, as indicated by the presence of the Sync message in the defibrillation information area.

2. Repeat steps 4 to 9 as described in 7.5.1Performing Synchronized Cardioversion.

If [Sync After Shock] is set to [Yes ], the equipment remains in the sync mode after a shock is delivered; if set to [No], the equipment exits the sync mode and enters the asynchronous defibrillation mode after a shock.

7.5.3 Disabling the Sync Function

To disable the Sync function, press the [Exit Sync] soft key.

Defibrillator/Monitor Operator’s Manual 7 - 7

7.6 Remote Synchronized Cardioversion

NOTE

The equipment can be configured to receive an ECG source from a remote patient monitor (such as a bedside patient monitor) to perform synchronized cardioversion. To do so, the remote patient monitor shall have a sync out connector and shall be connected to the multifunctional connector with a synchronous cable.

To switch on remote synchronized cardioversion, set [Remote Sync] to [On] in the [Manual Defib Setup] menu through the Configuration Main menu.

The remote synchronized cardioversion procedure is as follows:

1. Use a sync cable to connect the equipment with a bedside monitor through the multifunctional connector.

2. Enter the Manual Defib mode.

3. Press the [Enter Sync] soft key.

4. Select [Remote] to access remote synchronized cardioversion. Then the message “Remote Sync” is presented.

5. Confirm a square wave on the equipment blinks with each detected R wave on the remote monitor as shown below, indicating a sync pulse is received.

6. Connect the therapy cable to the therapy port. Push until you hear it clicks into place.

7. Apply electrode pads or external paddles to the patient.

8. Follow steps 6 to 9 as described in 7.5.1Performing Synchronized Cardioversion .

• During remote synchronized cardioversion, the local equipment does not display the ECG

waveform. To view the patient’s ECG, check the remote monitor.

• When you use a remote monitor as the ECG source, a biomedical technician must verify that the

remote monitor and the equipment combination will deliver a synchronized shock within 60 ms of the peak of the R-wave.

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7.7 Contact Impedance Indicator

NOTE

The contact impedance indicator is used to indicate the impedance between the patient and electrode pads/ external paddles in the Manual Defib mode and AED mode, as shown below:

The display of the contact impedance indicator is switched off by default. To switch it on, set [Contact Impedance Indicator] to [On] in the [Manual Defib Setup] menu through the Configuration Main menu.

The following table lists the indicator status of the measured impedance and the corresponding actions:

Contact Impedance Indicator

(illuminated in green)

(illuminated in yellow)

(illuminated in red)

(off )

Description Corrective Actions

indicates the patient contact is good, the impedance is suitable for the defibrillation.

indicates the patient contact is not good, the impedance is slightly higher for the defibrillation.

indicates the patient contact is very poor, or there is a short circuit between electrode pads or external paddles.The impedance is completely not suitable for the defibrillation.

indicates the ECG cable or therapy cable falls off.

Firmly attach the electrode pads or external paddles to the patient. or adjust the placements of electrode pads or external paddles until the indicator is illuminated in green.

If the indicator is still illuminated in yellow, it also can be used for the defibrillation. However, the expected effects may not be achieved in this condition.

Firmly attach the electrode pads or external paddles to the patient. or adjust the placements of electrode pads or external paddles until the indicator is illuminated in green or yellow.

Check that the ECG cable or therapy cable is properly connected to the equipment.

• It is recommended to perform the defibrillation on a patient when the contact impedance indicator

is illuminated in green. If the contact impedance indicator is illuminated in yellow, it also can be used for the defibrillation. However, the expected effects may not be achieved in this condition.

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8 CPR Feedback

NOTE

8.1 CPR Feedback Introduction

This chapter describes how to operate the equipment when a CPR sensor is connected. For details, refer to MR6401 CPR Sensor Operator’s Manual (P/N: 046-010423-00).

• The CPR sensor is not available in the markets of UK, Germany and France.

8.2 Operations with the CPR Sensor

When the equipment is connected with the CPR sensor, you can:

■ View a rea

■ Review CPR events.

■ Charge the CPR sensor configured with a battery.

■ Upload the latest one-hour data from the CPR sensor. For details, refer to 8.2.5Uploading CPR Data.

l-time compression waveform, CCI graph, compression rate and compression depth.

8.2.1 Connecting the CPR Sensor

1. Hold one end of the CPR sensor cable with the Mindray logo facing up, and plug it into the CPR sensor connector.

2. Fasten the CPR sensor cable with the cable retainer.

3. Try to pull the CPR sensor cable to make sure that the cable is securely connected.

4. Plug the other end of the sensor cable into the multifunctional connector at the rear of the equipment.

Defibrillator/Monitor Operator’s Manual 8 - 1

8.2.2 Using CPR Filter

CAUTION

NOTE

(1) (2)

(3) (4) (5)

Performing CPR introduces CPR artifact into the ECG signal. You can enable the CPR filter to see a close approximation of the patient’s underlying ECG rhythm when performing CPR.

To enable CPR filter:

1. Press the Main Menu button on the front panel, and then select [Others >>] → [Configuration >>] → enter the required password.

2. Select [CPR Setup] and set [CPR Filter] to [On].

3. Enter the CPR status by either of the following ways:

◆ In the Manual Defib mode, shake and compress the CPR sensor, or select the [CPR] softkey.

◆ In the AED mode, the system automatically enters the CPR status.

After you enable CPR filter, the equipment automatically starts filtering the CPR artifact when detecting the CPR compressions. The filtered ECG with the label “Filt.” is displayed on the second waveform of the screen.

The following figure shows the first ECG waveform and the filtered ECG waveform removing CPR artifact from the first ECG waveform. Compared with viewing the first ECG waveform, the filtered ECG is more obvious if you enable CPR filter.

When viewing the filtered ECG waveform, the CPR filter, the filter lead and filter gain cannot be set. The CPR filter can be turned on/off by setting [CPR Filter] through configuration management, the filter lead and filter gain can only be changed when you set lead and gain for the first ECG waveform.

Original ECG

Filtered ECG

(1) ECG lead label (2) ECG waveform gain (3) CPR filter lead

(4) CPR filter gain (5) CPR filter

• The CPR filter works only when you perform CPR using the CPR sensor in the AED or Manual Defib

mode.

• The CPR filter will not remove all CPR artifact. You should always follow the standard procedure of

stopping CPR to verify the patient’s ECG rhythm before making treatment decisions.

• The filtered ECG waveform must be used in conjunction with clinical signs and symptoms. It should

not be used as the sole basis for diagnosis or therapy decisions.

8 - 2 Defibrillator/Monitor Operator’s Manual

• There is a slight delay between the original and filtered ECG waveforms.

8.2.3 Viewing CPR Feedback

(1) (2) (3) (4)

To view CPR feedback:

1. Enter the CPR status by either of the following ways:

◆ In the Manual Defib mode, shake and compress the CPR sensor, or select the [CPR] softkey.

◆ In the AED mode, the system automatically enters the CPR status.

2. From the filtered ECG displayed on the second waveform of the screen, switch the filter lead with the label “Filt..” to [Comp.] by using the Navigation knob.

The following figure shows the CPR feedback, providing compression waveform, CCI graph, compression rate and compression depth.

(1) Compression waveform area

◆ Compression waveform: a real-time waveform depicted when you performing CPR.

◆ Compression depth scale

◆ Interruption time: displays interruption time in seconds since the last compression. When

stopping CPR, the compression waveform becomes a straight line. The system starts timing the CPR interruption.

◆ Prompt message: gives instructions for the current poor compression.

(2) CCI (CPR compression index) graph: indicates the current compression quality. The larger the blue

area, the better the compression quality.

◆ Depth axis: the current compression depth.

◆ Rate axis: the current compression rate.

◆ Recoil axis: the degree of recoil. Prompt message “Incomplete Recoil” will appear when the

compressed chest wall is not back to the natural position.

◆ Comp.% (Compression Fraction) axis: percentage of compression time within CPR duration.

(3) Compression rate area: indicates the current compression rate.

◆ Green: indicates that the compression rate is good.

◆ Red: indicates that the compression rate is poor. Prompt message “Compress Faster” or

“Compress Slower” will appear when the compression is slow or fast.

(4) Compression depth area: indicates the current compression depth.

◆ Green: indicates that the compression depth is good.

◆ Red: indicates that the compression depth is poor. Prompt message “Compress Deeper” or

“Compress Shallower” will appear when the compression is shallow or deep.

8.2.4 Reviewing CPR Events

To review CPR events on the equipment:

1. Enter the [CPR Setup] menu by either of the following ways:

◆ Press the Main Menu button on the front panel, and then select [Review >>] → [CPR Event

Review >>].

◆ In the Manual Defib mode, select the compression depth area or compression rate area → [CPR

Event Review >>].

2. In the [CPR Event List] window, you can:

◆ Select the desired CPR event.

Defibrillator/Monitor Operator’s Manual 8 - 3

◆ Select [Refresh] if there is power failure or CPR is interrupted within five minutes, and then select the

NOTE

desired CPR event.

• A CPR event is automatically saved in the equipment when the interruption time exceeds five

minutes.

• You should select [Refresh] to save a CPR event before disconnecting the CPR sensor from the

equipment.

8.2.5 Uploading CPR Data

If you use the CPR sensor independently, you can connect it to the equipment, and upload the latest one-hour data to the equipment. You can also review CPR events uploaded from the CPR sensor on the equipment.

For details about CPR event review, refer to 8.2.4Reviewing CPR Events.

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9 Noninvasive Pacing

NOTE

WARNING

CAUTION

NOTE

9.1 Pacing Introduction

In the Pacer mode, the patient’s ECG is monitored through ECG lead set and pace pulses are delivered through electrode pads. The electrode pads cannot be used to monitoring ECG rhythm and deliver pacing current at the same time.

A white pace marker is shown on the ECG waveform each time a pace pulse is delivered to the patient. If pacing in demand mode, white R-wave marker also appears on the ECG waveform until capture occurs.

During pacing, parameters except Resp continue to be monitored and parameter alarms remain active.

In demand mode pacing, a 3-lead or 5-lead ECG cable and electrodes are required to acquire ECG signal. Pace pulses are delivered through electrode pads. However, the electrode pads cannot be used to monitor the ECG and deliver pace pulses simultaneously.

• In the Pacer mode, arrhythmia analysis is supported and available arrhythmia alarms are asystole,

ventricular vibrillation and ventricular tachycardia.

9.2 Pacing Safety Information

• Heart rate displays and alarms function during pacing, but they can be unreliable. Observe the

patient closely while pacing. Do not rely on the indicated heart rate or heart rate alarms as a measure of the patient’s perfusion status.

• To avoid explosion hazard when pacing a patient who is receiving oxygen delivery, properly route

the oxygen delivery tube. Do not keep it close to the electrode pads.

• Monitoring ECG alone is sometimes not enough to verify that the patient’s heart is providing cardiac

output.a patient’s response to pacing shall be verified by signs of improved cardiac output, such as: a palpable pulse rate the same as the rate which pace pulses are being delivered, a rise in blood pressure, and/or improved skin color.

• Use of Pacer mode may be password protected. Make sure the operator knows and remembers the

password as defined in Configuration. Failure to enter correct password will prevent the delivery of pacing therapy.

• For treatment of patients with implanted devices such as permanent pacemakers or cardioverter-

defibrillators, consult a physician and the instructions for use provided by the device’s manufacturer

• Prolonged noninvasive pacing may cause patient skin irritation and burns. Periodically inspect the

underlying skin and change ECG electrodes and electrode pads.

• If pacing is interrupted for any reason, the [Start Pacing] soft key must be pressed to resume pacing.

• In the Pacer mode, you cannot change the patient’s internal paced status from the [ECG Setup]

menu.

• In the case that electrode pads poorly contact the patient, the alarm “Pacer Stopped Abnormally”

and “Pads Off” may be presented.

• Electrode pads are not an available choice for the source of ECG waveform in the Pacer mode.

Defibrillator/Monitor Operator’s Manual 9 - 1

9.3 Pacing View

CAUTION

(1)

(5)

(2)

(6)

(3)

(4)

A typical screen in the Pacer mode is shown below.

(1) Pacer mode

(2) Pacing prompt message

(3) ECG parameter and waveform area

This area displays HR numeric and one ECG waveform acquired from the ECG Lead set, and pace pulse delivered from the electrode pads.

(4) Auxiliary parameter and/or waveform area:

(5) Pacer rate

(6) Pacer output

9.4 Pacer Mode

The equipment can deliver pace pulses in either demand or fixed mode.

■ In demand mode, the pacer only delivers pace pulses when the patient’s heart rate is lower than the

selected pacer rate.

■ In fixed mode, the pacer delivers pace pulses at the selected rate.

During pacing, you can change the pacer mode. Then the equipment continues to deliver pace pulses at selected pacer rate and pacer output.

• Use demand mode pacing whenever possible. Use fixed mode pacing if noise or artifact interferes

with proper sensing of R-wave or when monitoring electrodes are not available.

• During fixed mode pacing, R-wave markers do not appear on the paced beats.

• During demand mode pacing, spontaneous beats may be presented which are not associated with

the delivery of pace pulse. If the patient’s heart rate is above the pacer rate, pace pulses are not delivered and, therefore, pace markers do not appear.

This area displays SpO

and CO2 parameters.

9 - 2 Defibrillator/Monitor Operator’s Manual

9.5 Preparing for Pacing

CAUTION

NOTE

Pace marker

1. Connect the electrode pads with pads cable, and then plug the pads cable into the therapy port.

2. Prepare the patient and apply the electrode pads to the patient. For details, refer to 5.4.1Preparing the Patient Skin and 5.4.3ECG Measurement with Electrode Pads.

3. If pacing in demand mode, apply monitoring electrodes, and connect the ECG cable to the equipment. To get the best monitoring signal, make sure there is adequate space between ECG electrodes and therapy electrodes. For details, refer to 5.4.2ECG Monitoring with Electrodes.

9.5.1 Demand Mode Pacing

To pace in demand mode pacing:

1. Switch the Mode Select knob to Pacer. Thus the pacing function is enabled in demand mode automatically. ECG waveform of Lead II is displayed in the waveform area by default.

You can define [Manual Therapy Access] by selecting [Manual Defib Setup] from the Configuration Main menu.You can also set [Default Pacer Mode] to define the default pacer mode by selecting [Pacer Setup] from the Configuration Main menu.

2. Press the Lead Select button on the front panel to select a lead with an easily detectable R-wave.

3. Verify that white R-wave markers appear above the R-waves. If the R-wave markers do not appear or do not coincide with the R-waves (for example above the T-waves), select another lead.

4. Use the Navigation knob to adjust the pacer rate, then press the Navigation knob. If necessary, select initial pacer output.

5. Press the [Start Pacing] soft key to start pacing. The message “Pacing” appears in the pacer information area.

6. Verify that white pace markers appear on the ECG waveform, as shown below:

7. Adjust pacer output. increase pacer output until cardiac capture occurs (capture is indicated by the appearance of a QRS complex after each pace marker), and then decrease the output to the lowest level that still maintains capture.

8. Verify the presence of a peripheral pulse.

You can temporarily withhold pace pulse and observe the patient’s underlying rhythm by pressing and holding the [4:1] soft key. This causes pacing pulse to be delivered at 1/4 of the defined pacer rate. To resume pacing at set rate, release this key.

To stop pacing, press the [Stop Pacing] soft key. Pressing the [Start Pacing] soft key can resume pacing.

• Routinely assess the patient’s cardiac output.

• Pacing will not start if there is a problem with the pads cable connection, pad patient connection, or

ECG monitoring electrodes connection. If any situation occurs, a message will appear in the pacer information area to alert you that a lead is disconnected or that the electrode pads have a poor connection.

Defibrillator/Monitor Operator’s Manual 9 - 3

9.5.2 Fixed Mode Pacing

WARNING

CAUTION

To pace in fixed mode pacing:

1. Switch the Mode Select knob to Pacer.

2. Use the Navigation knob to select [Fixed Mode], then press the Navigation knob.

3. If ECG electrodes are applied, press the Lead Select button on the front panel to select the desired lead.

4. Use the Navigation knob to adjust the pacer rate, then press the Navigation knob in. If necessary, select initial pacer output.

5. Press the [Start Pacing] soft key to start pacing. The message “Pacing” appears in the pacer information area.

6. Verify that white pace markers appear on the ECG waveform.

7. Adjust pacer output. Increase pacer output until cardiac capture occurs (capture is indicated by the appearance of a QRS complex after each pace marker), and then decrease the output to the lowest level that still maintains capture.

8. Verify the presence of a peripheral pulse.

You can temporarily withhold pace pulse and observe the patient’s underlying rhythm by pressing and holding the [4:1] soft key. This causes pace pulse to be delivered at 1/4 of the defined pacer rate. To resume pacing at set rate, release this key.

To stop pacing, press the [Stop Pacing] soft key.

• Use care when handling the electrode pads on the patient to avoid shock hazard during pacing.

• If you are using the pacing function with battery power and the Low Battery alarm is presented,

connect the equipment to external power or install a fully charged battery.

• The monitoring or pacing function may be unstable in the presence of ESU or other electronic

devices.

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10 Monitoring Resp

WARNING

(1) (2)

(3)

(5)

(4)

10.1 Resp Introduction

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 equipment screen.

Resp monitoring is intended for adult, pediatric and neonatal patients.

10.2 Resp Safety Information

• When monitoring the patient’s respiration, do not use ESU-proof ECG cables.

• The respiration measurement does not recognize obstructive and mixed apneas: it only indicates an

alarm when a pre-adjusted time had elapsed since the last detected breath. The safety and effectiveness of the respiration measurement method in the detection of apnea, especially the apnea of prematurity and apnea of infancy, has not been established.

10.3 Resp Display

(1) Resp waveform gain (2) Resp lead label (3) Resp alarm limits

(4) Respiration rate (RR) (5) RR unit

10.4 Placing Resp Electrodes

As the skin is a poor conductor of electricity, preparing the skin is necessary for a good respiration signal. For details, refer to 5.4.1Preparing the Patient Skin.

As the Respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables (3-lead or 5-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.

Defibrillator/Monitor Operator’s Manual 10 - 1

NOTE

• To optimize the respiration waveform, place the RA and LA electrodes horizontally when monitoring

NOTE

Lead I Lead II

respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with ECG Lead II.

10.4.1 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.

■ 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.

■ 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 optimize the respiratory wave.

■ 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 optimize the respiratory waveform.

• Respiration monitoring is not for use on the patients who are very active, as this will cause false

alarms.

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10.4.2 Changing Resp Settings

1. Select the Resp parameter area to enter the [Resp Setup] menu.

2. Make the following settings:

◆ Select [Gain] and then choose an appropriate setting. The bigger the gain is, the larger the wave amplitude is.

◆ Select [Sweep] and then choose an appropriate setting. The faster the wave sweeps, the wider the wave is.

◆ Select [Lead] to set lead for Resp monitoring.

◆ Select [Apnea Time] to define the time.

10.5 Resp Troubleshooting

For details, refer to EAlarm Messages.

Defibrillator/Monitor Operator’s Manual 10 - 3

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10 - 4 Defibrillator/Monitor Operator’s Manual

11 Monitoring PR

NOTE

(1)

(2)

(3)

11.1 PR Introduction

The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart. You can display a pulse from SpO2.

(1) PR alarm limits (2) PR unit (3) PR value

• A functional tester or SpO

simulator can be used to determine the pulse rate accuracy.

11.2 Adjusting Pulse Tone Volume

When PR alarm is switched on, the equipment gives out pulse tone.

To change the volume of pulse tone:

1. Select the PR parameter area to enter the [PR Setup] menu.

2. Set [QRS Volume].

When a valid SpO

value exists, the system will adjust the pitch of pulse tone according to the SpO2 value.

Defibrillator/Monitor Operator’s Manual 11 - 1

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11 - 2 Defibrillator/Monitor Operator’s Manual

12 Monitoring SpO

WARNING

12.1 SpO2 Introduction

SpO2 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 photodetector in the probe. The SpO2 module processes the electrical signal and displays a waveform and digital values for SpO

This equipment is calibrated to display functional oxygen saturation.

monitoring is intended for adult, pediatric and neonatal patients.

SpO

12.2 Identifying SpO2 Modules

The equipment can be configured with any of the following SpO2 modules.

■ Mindray SpO

■ Masimo SpO

■ Nellcor SpO

: the connector is blue without any no logo.

module: the connector is purple with a logo of Masimo SET.

: the connector is grey with a logo of Nellcor.

12.3 SpO2 Safety Information

and pulse rate.

• 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.

• Do not use SpO

potentially cause burns.

sensors during magnetic resonance imaging (MRI). Induced current could

• 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.

• 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.

• When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse

oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy.

• 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 off the alarm.

• SpO

is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin

(COHb) and methemoglobin (MetHb).

• To protect from electric shock, always remove the sensor and completely disconnect the pulse

oximeter before bathing the patient.

• The pulse oximeter is not an apnea monitor.

• The pulse oximeter should not be used for arrhythmia analysis.

Defibrillator/Monitor Operator’s Manual 12 - 1

CAUTION

• Change the application site or replace the sensor and/or patient cable when a persistent SpO2 Low

NOTE

Signal Quality message is displayed on the equipment. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor.

• Replace the cable or sensor when a “SpO2 Sensor Off”, “SpO2 No Sensor”, or “SpO2 Low Signal

Quality” message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual.

• Variation in measurements may be profound and may be affected by sampling technique as well as

the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition.

• Use only SpO

adhere to all warnings and cautions.

sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and

• Do not place the pulse oximeter where the controls can be changed by the patient.

• If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If the

sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period.

• Additional information specific to the Masimo sensors compatible with the equipment, including

information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).

• Masimo cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate

readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time.

• The SpO

only connect the Mindray SpO

• The SpO

extension cable should be compatible with the SpO2 connectors. For example, you can

simulator can be used to verify the accuracy of the SpO2 sensor.

extension cable to the Mindray SpO2 connectors.

12.4 SpO2 Measurement Limitations

The following factors may influence the accuracy of SpO2 measurement:

■ Patient physiological characteristics:

◆ Cardiac arrest

◆ Hypotension

◆ Darkly pigmented skin

◆ Shock

◆ Severe vasoconstriction

◆ Hypothermia

◆ Severe anemia

◆ Ventricular septal defects (VSDs)

◆ Venous pulsations

◆ Poor perfusion

◆ Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb)

◆ Elevated levels of bilirubin

◆ Vasospastic disease, such as Raynaud’s, and peripheral vascular disease

◆ Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc.

◆ Hypocapnic or hypercapnic conditions

◆ Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc.

12 - 2 Defibrillator/Monitor Operator’s Manual

■ Interfering substances:

NOTE

(1)

(2)

(3)

(6)

(4) (5)

◆ Intravascular dyes (such as indocyanine green, methylene blue, indigo carmine, etc.)

◆ Dyes in the measure site, such as nail polish.

■ Environmental conditions:

◆ Excessive ambient light

◆ Electrosurgery equipment. The pulse oximeter may be used during electrocautery, but this may affect

the accuracy or availability of the parameters and measurements.

◆ Defibrillation (may cause inaccurate reading for a short amount of time)

◆ Excessive patient/sensor motion

◆ Electromagnetic field

◆ Arterial catheters and intra-aortic balloon

■ Others

◆ Inappropriate positioning of the SpO

◆ Cuff or arterial blood pressure measurement device on the same limb as the SpO2 sensor.

12.5 SpO2 Display

sensor, or use of incorrect SpO2 sensor

(1) Pleth waveform (Pleth): visual indication of patient’s pulse. The waveform is not normalized.

(2) SpO

(3) SpO

(4) Oxygen saturation of arterial blood (SpO

(5) Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.

(6) Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal

unit

alarm limits

): percentage of oxygenated hemoglobin in relation to

the sum of oxyhemoglobin and deoxyhemoglobin.

caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to assess the SpO

signal strength.

◆ If the “SpO2 Low Perf” alarm persists, reposition the SpO

sensor or find a better site.

◆ If low perfusion persists, choose another method to measure oxygen saturation if possible.

• PI is only available for Masimo SpO

Defibrillator/Monitor Operator’s Manual 12 - 3

12.6 SpO2 Monitoring Procedure

1. Select an appropriate sensor according to the module type, patient category and weight.

2. Clean the application site, e.g. removing colored nail polish from the application site.

3. Apply the sensor to the patient.

4. Select an appropriate extension cable according to the connector type and connect it with the equipment.

5. Connect the sensor cable to the extension cable.

6. Switch the Mode Select knob to Monitor.

12.7 Changing SpO2 Settings

You can enter the [SpO2 Setup] menu by selecting the SpO2 parameter area.

12.7.1 Changing the Speed of the Pleth Wave

In the [SpO2 Setup] menu, you select the appropriate setting from [Sweep]. The faster the wave sweeps, the wider the wave is.

12.7.2 Monitoring SpO2 and NIBP on the Same Limb

When monitoring SpO2 and NIBP on the same limb simultaneously, you can enable [NIBP Simul] from the [SpO2 Setup] menu to lock the SpO2 alarm status until the NIBP measurement ends. If you disable [NIBP Simul], low perfusion caused by NIBP measurement may lead to inaccurate SpO2 readings and therefore cause false physiological alarms.

12.7.3 Sat-Seconds Alarm Management (for Nellcor SpO2)

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’s SpO value fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarm can be distracting.

The Sat-Seconds feature is available with the Nellcor SpO caused by motion artifacts. The Sat-Seconds limit controls the amount of time that SpO2 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 remains outside the limit. This can be stated as the equation: Sat-Seconds= Points × Seconds

Only when the Sat-Seconds limit is reached, the equipment gives a Sat-Seconds alarm. The figure below demonstrates the alarm response time with a Sat-Seconds limit set at 50 and a low SpO example, the patient’s SpO2 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:

After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50 Sat-Seconds would have been exceeded.

saturation falls outside the alarm limit is multiplied by the number of seconds that it

Points Seconds Sat-Seconds

2× 2 = 4

4× 3 = 12

6× 6 = 36

Tot al Sat-S eco nds = 52

module to decrease the likelihood of false alarms

limit set at 90%. In this

Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Normally, the patient’s SpO During such fluctuation, the system sums the number of SpO2 points, both positive and negative, until either the Sat-Seconds limit is reached, or the patient’s SpO2 re-enters the non-alarm range and remains there.

12 - 4 Defibrillator/Monitor Operator’s Manual

may fluctuate above and below an alarm limit, re-entering the non-alarm range several times.

12.7.4 Setting SpO2 Sensitivity (for Mindray SpO2)

CAUTION

The SpO2 value displayed on the screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the equipment responds to changes in the patient’s oxygen saturation level, but the measurement accuracy is relatively low. Contrarily, the longer the averaging time is, the slower the equipment responds to changes in the patient’s oxygen saturation level, but the measurement accuracy will be improved. When monitoring critically ill patients, selecting shorter averaging time will help understanding the patient’s condition.

For Mindray SpO which respectively correspond to 7 s, 9 s and 11 s.

module, you can set [Sensitivity] to [High], [Med] or [Low] from the [SpO2 Setup] menu,

12.7.5 Setting SpO2 Sensitivity (for Masimo SpO2)

For Masimo SpO2 module, you can set [Sensitivity] to [High], [Normal] or [APOD] from the [SpO2 Setup] menu.

Normal sensitivity is the recommended for patients who are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as the intensive care unit (ICU).

Adaptive Probe Off Detection (APOD) sensitivity is the recommended sensitivity mode where there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement.

Maximum sensitivity is recommended for use on patients with weak signals (e.g. high ambient noise and/or patients with very low perfusion) and for use during procedures or when clinician and patient contact is continuous such as in higher acuity settings.

• When using the Maximum Sensitivity setting, performance of “SpO2 Sensor Off” detection may be

compromised. If the equipment and the sensor becomes detached from the patient, the potential for false readings may occur due to environmental noise such as light, and vibration.

12.7.6 Changing Averaging Time (for Masimo SpO2)

For Masimo SpO2 module, you can set [Average Time] to [2-4 s], [4-6 s], [8 s], [10 s], [12 s], [14 s] or [16 s] from the [SpO2 Setup] menu.

12.7.7 Enabling FastSAT (for Masimo SpO2)

FastSAT enables rapid tracking of arterial oxygen saturation changes as may be required in urgent situations. When FastSAT is switched on, the averaging algorithm evaluates all the SpO SpO2 value that is a better representation of the patient’s current oxygen saturation status.

The reliability of FastSAT is dependent on the setting for the averaging time and the input signal. To enable FastSAT, set [Fast SAT] to [On] from the [SpO2 Setup] menu.

values and provides an averaged

12.7.8 Displaying SIQ (for Masimo SpO2)

The signal quality indicator (SIQ) displays below the Pleth waveform. The SIQ is conveyed by vertical bars. The height of the bar provides an assessment of the confidence in the displayed SpO be used to identify the occurrence of a patient ‘s pulse.

The following picture shows the SpO2 SIQ.

Defibrillator/Monitor Operator’s Manual 12 - 5

value. The SpO2 SIQ can also

NOTE

(1) Signal quality indicator (SIQ)

( 1 )

To d isplay S pO2 SIQ, set [Display SIQ] to [On] from the [SpO2 Setup] menu.

12.7.9 Displaying PI (for Masimo SpO2)

For Masimo SpO2 module, you can set whether to display PI in the SpO2 parameter area. To display PI, set [Display PI] to [On] from the [SpO2 Setup] menu.

12.7.10 Setting the Alarm Delay Time (for Masimo SpO2)

For Masimo SpO2 module, you can set [Alarm Delay] by selecting [SpO2 Setup] from the Configuration Main menu. If the alarm condition related to Masimo SpO equipment does not present the alarm.

is resolved within the configured time period, the

12.8 SpO2 Desat Alarm

The equipment provides a SpO2 Desat alarm. The SpO2 Desat alarm provides an additional limit setting below the SpO Desat alarm is a high-level exclusive alarm. You cannot change its alarm level.

To set the Desat alarm:

1. Enter the [Para. Alarm] menu by either of the following ways.

2. Set [Desat].

low limit setting to notify you of potentially life threatening decreases in oxygen saturation. The SpO2

◆ Press the Main Menu button on the front panel, and then select [Alarm Setup >>] → [Para. Alarm >>].

◆ Select the SpO

parameter area and then select [Para. Alarm >>].

• In the case that the SpO

automatically adjusted to the Desat value.

low limit alarm value is set below the Desat limit, the SpO2 low limit is

12.9 Pitch Tone

The pitch tone function enables the equipment to give variable pitches of heartbeat tone or pulse tone as the patient’s SpO pulse tone rises as SpO

There are two pitch tone modes. You can set [Pitch Tone] to select the pitch tone mode by selecting [SpO2 Setup] from the Configuration Main menu.

If the SpO2 is disabled, the pitch tone function will be disabled also.

level changes. This equipment provides two modes of pitch tones. The pitch of heartbeat tone or

level increases and falls as SpO2 level decreases.

12.10 SpO2 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.

• For the physiological and technical alarm messages, refer to EAlarm Messages.

12 - 6 Defibrillator/Monitor Operator’s Manual

Problem Corrective Actions

Do not see SpO

parameter area or

waveform area on the screen

Dashes “- -” display in place of numerics. 1. Check that the cable connections of SpO

Low amplitude

SpO

value is inaccurate 1. Check the patient’s vital signs.

SpO

signal 1. The SpO2 sensor and NIBP cuff are placed on the same limb. Change a

12.11 Nellcor Information

Check that the cable connections of SpO2 sensor and the extension cable are tight. Replace the SpO

cable are tight. Replace the SpO needed.

2. Reconnect the SpO

sensor or the extension cable if needed.

sensor and the extension

sensor or the extension cable if

sensor if the alarm “SpO2 Sensor Off” appears.

3. Check the perfusion indicator. If the perfusion indicator is too low, adjust the SpO perfusion.

sensor, or apply the sensor to the site with better

4. Move the sensor to the place with weaker light, or cover the sensor with shade cloth if the alarm “SpO2 Sensor Off” appears.

monitoring site if necessary.

2. Check the perfusion indicator. If the perfusion indicator is too low. Adjust the SpO perfusion.

sensor, or apply the sensor to the site with better

3. Check the sensor and its application site.

2. Check for conditions that may cause inaccurate SpO

readings. For

details, refer to 12.4SpO2 Measurement Limitations.

3. Check the equipment and the SpO

module for proper functioning.

■ 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.

12.12 Masimo Information

■ Masimo Patents

This device may be covered by one or more of the following US patents and foreign equivalents: 5,758,644, 6,011,986, 6,699,194, 7,215,986, 7,254,433, 7,530,955.

■ 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.

Defibrillator/Monitor Operator’s Manual 12 - 7

12.13 Masimo End-User License Agreement

THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (“PURCHASER”) AND SHENZHEN MINDRAY. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO SHENZHEN MINDRAY FOR A FULL REFUND.

1. Grant of License. In consideration of payment of the license fee, which is part of the price paid for this product, Shenzhen Mindray grants to Purchaser a nonexclusive, nontransferable license, without right to sublicense, to use the copy of the incorporated software/firmware, and documentation in connection with Purchaser's use of the Masimo Products for their labeled purpose. Shenzhen Mindray reserves all rights not expressly granted to Purchaser.

2. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any Masimo software and/or firmware and the documentation, and all copies thereof, remain at all times vested in Masimo Corporation, licensor to Shenzhen Mindray, and they do not pass to Purchaser.

3. Assignment. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise, without Shenzhen Mindray's prior written consent; any attempt without such consent, to assign any rights, duties or obligations arising hereunder shall be void.

4. Copy Restrictions. The software/firmware, mask works, circuit board layouts, and accompanying written materials are copyrighted. Unauthorized copying of the software, including software that has been modified, merged, or included with other software, or other written materials is expressly forbidden. You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17 U.S.C. §117.

5. Use Restriction. As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not electronically transfer the software/ firmware from the products to any other device. You may not disclose, publish, translate, release distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Masimo Product, the software/firmware, or the written materials without the prior written consent of Masimo. Masimo Sensors that are designated for single use are licensed under Masimo patents for use on a single patient only, and are not sold. There is no license, implied or otherwise, that would allow use of single use Masimo Sensors beyond their intended single use. After use of single use Masimo Sensors, there is no further license granted by Masimo to use the sensors and they must be discarded.

6. Transfer Restrictions. The software/firmware is licensed to the Purchaser, and may not be transferred to anyone, except other end-users, without the prior written consent of Shenzhen Mindray. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis.

7. Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions.

U.S. Government Rights: If you are acquiring software (including the related documentation) on behalf of any part of the United States Government, the following provisions apply: the software is deemed to be “commercial software” and “commercial computer software documentation,” respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this agreement.

12 - 8 Defibrillator/Monitor Operator’s Manual

13 Monitoring NIBP

NOTE

WARNING

13.1 NIBP Introduction

Automatic non-invasive blood pressure monitoring uses the oscillometric method of measurement. It is intended for adult, pediatric and neonatal patients. 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 equipment cannot hear the blood pressure, it measures cuff pressure oscillation amplitudes. Oscillations are caused by blood pressure pulses against the cuff. The oscillation with the greatest amplitude is the mean pressure. 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 in ISO 80601-2-30, NIBP monitoring is allowed while an electrosurgical operation is in progress or a defibrillation shock is being delivered.

NIBP monitoring is intended for adult, pediatric and neonatal patients.

• 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.

13.2 NIBP Safety Information

• 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 any condition 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 readings, determines the patient’s vital signs by alternative means and then verify that the equipment is working correctly.

• Do not use the NIBP cuff on the arm on the side of a mastectomy or lymph node clearance.

• Continuous CUFF pressure due to connection tubing kinking may cause blood flow interference and

resulting harmful injury to the patient.

• NIBP diagnostic significance must be decided by the physician.

Defibrillator/Monitor Operator’s Manual 13 - 1

13.3 NIBP Measurement Limitations

(8)

(1) (2)

(3)

(6) (5) (4)

(7)

Measurements are impossible with heart rate extremes of less than 30 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine.

The measurement may be inaccurate or impossible in the following situations:

■ 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.

13.4 Measurement Modes

There are three modes 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.

13.5 NIBP Display

The NIBP display shows numerics only as below. Your display may be configured to look slightly different.

(1) Measurement mode (2) NIBP unit: mmHg or kPa

(3) Mean pressure at the completion of measurement, or cuff pressure during the measurement.

(4) Diastolic pressure (5) NIBP prompt message

(6) Systolic pressure (7) Time of last measurement

(8) NIBP alarm limits

13 - 2 Defibrillator/Monitor Operator’s Manual

13.6 NIBP Measurement Procedure

NOTE

13.6.1 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 and arm supported

■ Middle of the cuff at the level of the right atrium of the heart

• It is recommended that the patient relaxes as much as possible before performing measurement

and that the patient does not talk during NIBP measurement.

• It is recommended that 5 min should elapse before the first reading is taken.

• A wrong cuff size and a folded or twisted bladder can cause inaccurate measurements.

• Do not touch or apply external pressure against the cuff and air tubing during NIBP measurement.

This may cause inaccurate blood pressure values.

13.6.2 Preparing for NIBP Measurement

1. Verify that the patient category is correct. Change it if necessary.

2. Plug the air tubing into the equipment’s NIBP connector.

3. Select a correct sized 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.

4. Apply the cuff to an upper arm or thigh of the patient and make sure the Φ marking on the cuff matches the artery location. Do not wrap the cuff too tightly around the limb. 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 and make sure that the air tubing is not compressed or twisted. Air must pass unrestricted through the tubing.

6. Switch the Mode Select knob to Monitor.

13.6.3 Starting and Stopping NIBP Measurements

You can start and stop NIBP measurements by pressing the NIBP button on the front panel.

13.6.4 Correcting the Measurement

The cuffed limb should be at the same level as the patient’s heart. If not, correct the measurement by:

■ Add 0.75 mmHg (0.10 kPa) for each centimeter higher, or

■ Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower.

13.6.5 Starting Auto NIBP Measurements

1. Select the NIBP parameter area to enter the [NIBP Setup] menu.

2. Select [Interval] and then select a desired time interval except [Manual]. Selecting [Manual] switches to manual mode.

3. Press the NIBP button measurements at the set time interval.

Defibrillator/Monitor Operator’s Manual 13 - 3

on the front panel. The equipment will then automatically repeat NIBP

WARNING

• Continuous non-invasive blood pressure measurements may cause purpura, ischemia and

NOTE

neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the extremity of 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.

13.6.6 Starting a STAT Measurement

1. Select the NIBP parameter area to enter the [NIBP Setup] menu.

2. Select [NIBP STAT]. The STAT mode initiates a 5-minute continuous, automatic NIBP measurement.

13.7 Setting Initial Cuff Inflation Pressure

You can set the initial cuff inflation pressure manually.

1. Select the NIBP parameter area to enter the [NIBP Setup] menu.

2. Select [Initial Pressure] and then select the appropriate setting. The cuff is inflated accordingly at the next NIBP measurement.

• For known hypertensive patients, you need to set initial cuff pressure to a higher value to reduce the

measurement time.

• Setting initial cuff inflation pressure is disabled during NIBP measurement.

• The initial cuff inflation pressure is restored to the default setting if NIBP module has been reset or

patient category has been changed.

13.8 Setting Pressure Unit

You can s et [Press. Unit] to change NIBP unit only by selecting [NIBP Setup] from the Configuration Main menu.

13.9 NIBP Troubleshooting

For details, refer to EAlarm Messages.

13 - 4 Defibrillator/Monitor Operator’s Manual

Shenzhen BeneHeart D3, BeneHeart D2 Operator’s Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Intellectual Property Statement

Responsibility on the Manufacturer Party

Warranty

Company Contact

Preface

1 Safety

1.1 Safety Information

1.1.1 Dangers

1.1.2 Warnings

1.1.3 Cautions

1.1.4 Notes

1.2 Equipment Symbols

2 The Basics

2.1 Equipment Introduction

2.2 Intended Use

2.2.1 AED

2.2.2 Manual Defibrillation

2.2.3 Noninvasive Pacing

2.2.4 ECG

2.2.5 Resp

2.2.6 PR

2.2.8 NIBP

2.2.10 CPR Feedback

2.3 Applied Parts

2.4 Main Unit

2.4.1 Front View

2.4.2 Left View

2.4.3 Right View

2.4.4 Rear View

2.5 External Paddles

2.6 Display Views

3 Basic Operations and Settings

3.1 Equipment Installation

3.1.1 Unpacking and Checking

3.1.2 Environmental Requirements

3.2 Basic Operation

3.2.1 Connecting the AC Mains

3.2.2 Installing the Battery

3.2.3 Turning On the Equipment

3.2.4 Starting Monitoring or Therapy

3.2.5 Using the Main Menu

3.2.6 Using the Navigation knob

3.2.7 Editing Current Patient Information

3.2.8 Turning Off the Equipment

3.2.9 Auto Restoring to Last Configuration

3.3 Changing General Settings

3.3.1 Setting the Date and Time

3.3.2 Adjusting the Screen Brightness

3.3.3 Changing Key Volume

3.3.4 Selecting High Contrast Display

3.3.5 Adjusting Waveform Position

3.4 Analog Output

4 Alarms

4.1 Alarm Categories

4.2 Alarm Levels

4.3 Alarm Indicators

4.3.1 Alarm Lamps

4.3.2 Audible Alarms

4.3.3 Alarm Messages

4.3.4 Flashing Numerics

4.3.5 Alarm Status Symbols

4.4 Alarm Tone Configuration

4.4.1 Changing the Alarm Volume

4.4.2 Setting the Reminder Tones

4.4.3 Setting the Interval between Alarm Sounds

4.5 Understanding the Alarm Setup Menu

4.5.1 Setting Alarm Properties for All Parameters

4.5.2 Adjusting Alarm Limits Automatically

4.6 Pausing Alarms

4.7 Switching Alarms Off

4.8 Switching Off Alarm Sounds

4.9 Resetting Alarms

4.10 Latching Alarms

4.11 Clearing Technical Alarms

4.12 Testing Alarms

4.13 Actions When an Alarm Occurs