Mindray BeneHeart D3 Operator's Manual

BeneHeart D3

Defibrillator/Monitor

Operator’s Manual

I

© 2010 - 2013 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

For this Operator’s Manual, the issue date is 2013-09.

II

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property

rights to this Mindray product and this manual. This manual may refer to information protected by copyright or

patents and does not convey any license under the patent rights or copyright of Mindray, or 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, adaptation, translation or any other derivative work of this

manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , and are the trademarks, registered or otherwise, of

Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational

or editorial purposes. They are the property of their respective owners.

III

Responsibility on the Manufacturer Party

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

All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained

herein or 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;and
 the product is used in accordance with the instructions for use.

WARNING

z

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

z

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.

IV

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 orunauthorized 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,Hi-tech industrial

park,Nanshan,Shenzhen 518057,P.R.China

Website: www.mindray.com

E-mail Address: [e-mail]

Tel: [phone]

Fax: [phone]

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

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: [phone]

Fax: [phone]

V

Preface

Manual Purpose

This manual contains the instructions necessary to operate the product safely and in accordance with its function and

intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and

ensures patient and operator safety.

This manual is based on the maximum configuration and therefore some contents may not apply to your product. If

you have any 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.

VI

FOR YOUR NOTES

1

Contents

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

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

1.1.1 Dangers ...................................................................................................................................................................................................1-2

1.1.2 Warnings .................................................................................................................................................................................................1-2

1.1.3 Cautions ..................................................................................................................................................................................................1-3

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

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

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

2.1 Overview...............................................................................................................................................................................................................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 SpO2..........................................................................................................................................................................................................2-2

2.2.7 NIBP...........................................................................................................................................................................................................2-2

2.3 Main Unit ..............................................................................................................................................................................................................2-3

2.3.1 Front View...............................................................................................................................................................................................2-3

2.3.2 Side View.................................................................................................................................................................................................2-8

2.3.3 Rear View.................................................................................................................................................................................................2-9

2.3.4 External Paddles................................................................................................................................................................................ 2-10

2.4 Display Views.................................................................................................................................................................................................... 2-11

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

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

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

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

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

3.2.1 Turning Power On................................................................................................................................................................................3-2

3.2.2 Starting Monitoring or Therapy......................................................................................................................................................3-2

3.2.3 Disconnecting from Power...............................................................................................................................................................3-3

3.2.4 Auto Restoring to Last Configuration...........................................................................................................................................3-3

3.3 Using the Main Menu.......................................................................................................................................................................................3-3

3.4 Changing General Settings ............................................................................................................................................................................3-3

3.4.1 Setting the Date and Time................................................................................................................................................................3-3

3.4.2 Adjusting the Screen Brightness....................................................................................................................................................3-4

3.4.3 Changing Key Volume........................................................................................................................................................................3-4

3.4.4 Selecting High Contrast Mode........................................................................................................................................................3-4

2

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

4.1 Overview .............................................................................................................................................................................................................. 4-1

4.2 Editing Patient Information........................................................................................................................................................................... 4-1

5 Alarms........................................................................................................................................................................... 5-1

5.1 Alarm Categories ............................................................................................................................................................................................... 5-1

5.2 Alarm Levels ........................................................................................................................................................................................................5-2

5.3 Alarm Indicators................................................................................................................................................................................................. 5-2

5.3.1 Alarm Lamps .........................................................................................................................................................................................5-2

5.3.2 Audible Alarms..................................................................................................................................................................................... 5-3

5.3.3 Alarm Message ..................................................................................................................................................................................... 5-3

5.3.4 Flashing Numeric................................................................................................................................................................................. 5-3

5.3.5 Alarm Status Symbols........................................................................................................................................................................ 5-3

5.4 Alarm Tone Configuration.............................................................................................................................................................................. 5-4

5.4.1 Changing the Alarm Volume........................................................................................................................................................... 5-4

5.4.2 Setting the Interval between Alarm Sounds .............................................................................................................................5-4

5.5 Understanding the Alarm Setup Menu..................................................................................................................................................... 5-4

5.5.1 Setting Alarm Properties for All Parameters.............................................................................................................................. 5-5

5.5.2 Adjusting Alarm Limits Automatically......................................................................................................................................... 5-6

5.6 Pausing Alarms................................................................................................................................................................................................... 5-7

5.7 Switching Alarms Off ....................................................................................................................................................................................... 5-7

5.8 Pausing Alarm Sounds..................................................................................................................................................................................... 5-8

5.9 Switching Off Alarm Sounds .........................................................................................................................................................................5-8

5.10 Reminder Tones...............................................................................................................................................................................................5-8

5.11 Latching Alarms............................................................................................................................................................................................... 5-9

5.12 Clearing Technical Alarms............................................................................................................................................................................ 5-9

5.13 When an Alarm Occurs................................................................................................................................................................................5-10

6 Monitoring ECG............................................................................................................................................................ 6-1

6.1 Overview .............................................................................................................................................................................................................. 6-1

6.2 Safety .....................................................................................................................................................................................................................6-1

6.3 Monitoring View ................................................................................................................................................................................................6-2

6.4 Preparing to Monitor ECG ..............................................................................................................................................................................6-2

6.4.1 ECG Monitoring with Electrodes.................................................................................................................................................... 6-2

6.4.2 ECG Monitoring with Paddles/Pads.............................................................................................................................................. 6-4

6.4.3 Checking Paced Status ...................................................................................................................................................................... 6-5

6.5 ECG Display.......................................................................................................................................................................................................... 6-5

6.6 Changing ECG Settings ...................................................................................................................................................................................6-6

6.6.1 Changing Lead Settings.................................................................................................................................................................... 6-6

6.6.2 Changing ECG Wave Settings..........................................................................................................................................................6-7

6.6.3 Switching the Notch Filter On or Off............................................................................................................................................ 6-7

6.6.4 Adjusting Heartbeat Volume...........................................................................................................................................................6-8

6.7 Arrhythmia Analysis.......................................................................................................................................................................................... 6-8

6.7.1 Understanding the Arrhythmia Events........................................................................................................................................6-8

6.7.2 Switching Arrhythmia Analysis On and Off ...............................................................................................................................6-9

6.7.3 Changing Arrhythmia Alarm Settings........................................................................................................................................6-10

3

6.7.4 Changing Arrhythmia Threshold Settings............................................................................................................................... 6-10

6.7.5 Initiating Arrhythmia Relearning Manually............................................................................................................................. 6-11

6.7.6 Automatic Arrhythmia Relearn.................................................................................................................................................... 6-11

6.8 Calibrating ECG................................................................................................................................................................................................ 6-11

7 AED ............................................................................................................................................................................... 7-1

7.1 Overview...............................................................................................................................................................................................................7-1

7.2 Safety......................................................................................................................................................................................................................7-1

7.3 AED View...............................................................................................................................................................................................................7-2

7.4 AED Procedure....................................................................................................................................................................................................7-3

7.5 Shock Advised.....................................................................................................................................................................................................7-4

7.6 No Shock Advised (NSA)..................................................................................................................................................................................7-4

7.7 CPR ..........................................................................................................................................................................................................................7-5

7.7.1 CPR Metronome ...................................................................................................................................................................................7-5

7.8 AED Sound Recording......................................................................................................................................................................................7-6

7.9 AED Setup.............................................................................................................................................................................................................7-6

8 Manual Defibrillation .................................................................................................................................................. 8-1

8.1 Overview...............................................................................................................................................................................................................8-1

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

8.3 Manual Defibrillation View.............................................................................................................................................................................8-3

8.4 Manual Defibrillation Procedure..................................................................................................................................................................8-3

8.4.1 Using Pediatric Paddles.....................................................................................................................................................................8-5

8.4.2 Using Internal Paddles .......................................................................................................................................................................8-5

8.5 Synchronized Cardioversion..........................................................................................................................................................................8-6

8.5.1 Performing Synchronized Cardioversion....................................................................................................................................8-7

8.5.2 Delivering Additional Synchronized Shocks..............................................................................................................................8-7

8.5.3 Disabling the Sync Function............................................................................................................................................................8-7

8.6 Remote Synchronized Cardioversion.........................................................................................................................................................8-8

8.7 Contact Impedance Indicator .......................................................................................................................................................................8-9

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

9.1 Overview...............................................................................................................................................................................................................9-1

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

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

9.4 Demand Mode versus Fixed Mode..............................................................................................................................................................9-3

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

9.5.1 Demand Mode Pacing .......................................................................................................................................................................9-4

9.5.2 Fixed Mode Pacing..............................................................................................................................................................................9-5

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

10.1 Overview ......................................................................................................................................................................................................... 10-1

10.2 Safety ................................................................................................................................................................................................................10-1

10.3 Resp View ........................................................................................................................................................................................................ 10-1

10.4 Placing Resp Electrodes .............................................................................................................................................................................10-2

10.4.1 Optimizing Lead Placement for Resp...................................................................................................................................... 10-3

4

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

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

11.1 Overview ..........................................................................................................................................................................................................11-1

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

12 Monitoring SpO2...................................................................................................................................................... 12-1

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

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

12.3 Identifying SpO2 Modules..........................................................................................................................................................................12-2

12.4 SpO2 Monitoring Procedure......................................................................................................................................................................12-2

12.5 Changing SpO2 Settings .............................................................................................................................................................................12-3

12.5.1 Setting SpO2 Sensitivity ................................................................................................................................................................12-3

12.5.2 Monitoring SpO2 and NIBP on the Same Limb.....................................................................................................................12-3

12.5.3 Changing Averaging Time ...........................................................................................................................................................12-3

12.5.4 Sat-Seconds Alarm Management .............................................................................................................................................12-4

12.5.5 Changing the Speed of the Pleth Wave..................................................................................................................................12-5

12.6 SpO2 Desat Alarm..........................................................................................................................................................................................12-5

12.7 Pitch Tone.........................................................................................................................................................................................................12-5

12.8 Measurement Limitations..........................................................................................................................................................................12-5

12.9 Masimo Information ....................................................................................................................................................................................12-6

12.10 Nellcor Information....................................................................................................................................................................................12-6

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

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

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

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

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

13.5 Measuring Procedure ..................................................................................................................................................................................13-2

13.5.1 Preparing for NIBP Measurement .............................................................................................................................................13-2

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

13.5.3 Correcting the Measurement .....................................................................................................................................................13-3

13.5.4 Enabling NIBP Auto Cycling ........................................................................................................................................................13-3

13.5.5 Starting a STAT Measurement ....................................................................................................................................................13-3

13.6 Understanding the NIBP Numerics ........................................................................................................................................................13-4

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

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

14 Marking Events ........................................................................................................................................................14-1

15 Freezing Waveforms................................................................................................................................................ 15-1

15.1 Freezing Waveforms.....................................................................................................................................................................................15-1

15.2 Reviewing Frozen Waveforms ..................................................................................................................................................................15-1

15.3 Unfreezing Waveforms................................................................................................................................................................................15-2

15.4 Recording Frozen Waveforms...................................................................................................................................................................15-2

5

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

16.1 Reviewing Events .........................................................................................................................................................................................16-1

16.2 Reviewing Tabular Trends..........................................................................................................................................................................16-2

17 Data Management................................................................................................................................................... 17-1

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

17.2 Reviewing Patient Events.......................................................................................................................................................................... 17-2

17.3 Exporting Data ..............................................................................................................................................................................................17-2

18 Recording .................................................................................................................................................................18-1

18.1 Using a Recorder........................................................................................................................................................................................... 18-1

18.2 Recording Types............................................................................................................................................................................................ 18-1

18.3 Starting and Stopping Recordings ........................................................................................................................................................ 18-1

18.4 Setting the Recorder ................................................................................................................................................................................... 18-2

18.4.1 Accessing the Record Setup Menu ..........................................................................................................................................18-2

18.4.2 Selecting Waveforms for Recording ........................................................................................................................................18-2

18.4.3 Setting the Realtime Recording Length................................................................................................................................. 18-2

18.4.4 Changing the Recording Speed................................................................................................................................................ 18-3

18.4.5 Switching Gridlines On or Off ....................................................................................................................................................18-3

18.5 Loading Paper................................................................................................................................................................................................ 18-3

18.6 Removing Paper Jam ..................................................................................................................................................................................18-4

18.7 Cleaning the Recorder Print head.......................................................................................................................................................... 18-4

19 Configuration Management................................................................................................................................... 19-1

19.1 Introduction ...................................................................................................................................................................................................19-1

19.2 Password..........................................................................................................................................................................................................19-1

19.3 Accessing Configuration Management................................................................................................................................................19-1

19.3.1 General Setup Menu ..................................................................................................................................................................... 19-2

19.3.2 Manual Defib Setup Menu .......................................................................................................................................................... 19-3

19.3.3 AED Setup Menu ............................................................................................................................................................................ 19-3

19.3.4 Pacer Setup Menu.......................................................................................................................................................................... 19-4

19.3.5 ECG Setup Menu............................................................................................................................................................................. 19-4

19.3.6 Resp Setup Menu ........................................................................................................................................................................... 19-6

19.3.7 SpO2 Setup Menu ........................................................................................................................................................................... 19-6

19.3.8 PR Setup Menu................................................................................................................................................................................ 19-6

19.3.9 NIBP Setup Menu............................................................................................................................................................................ 19-7

19.3.10 Alarm Setup Menu....................................................................................................................................................................... 19-8

19.3.11 Waveform Setup Menu .............................................................................................................................................................. 19-8

19.3.12 Mark Event Setup Menu ............................................................................................................................................................ 19-9

19.3.13 Record Setup Menu .................................................................................................................................................................... 19-9

19.3.14 Data Management Setup Menu............................................................................................................................................. 19-9

19.3.15 User Test Setup Menu...............................................................................................................................................................19-10

19.3.16 Others Menu................................................................................................................................................................................19-10

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

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

6

20.2 Installing the Batteries ................................................................................................................................................................................20-2

20.3 Battery Alarms................................................................................................................................................................................................20-2

20.3.1 No Battery Alarm.............................................................................................................................................................................20-2

20.3.2 Low Battery Alarm ..........................................................................................................................................................................20-2

20.3.3 Battery Aged Alarm........................................................................................................................................................................20-3

20.3.4 Battery Error Alarm.........................................................................................................................................................................20-3

20.4 Checking the Batteries................................................................................................................................................................................20-3

20.5 Charging batteries........................................................................................................................................................................................20-3

20.6 Storing Batteries............................................................................................................................................................................................20-4

20.7 Recycling the Batteries................................................................................................................................................................................20-4

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

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

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

21.3 Disinfecting.....................................................................................................................................................................................................21-2

22 Maintenance and Testing........................................................................................................................................ 22-1

22.1 Overview ..........................................................................................................................................................................................................22-1

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

22.3 Carrying Out Maintenance and Testing................................................................................................................................................22-2

22.3.1 Power-on Tests.................................................................................................................................................................................22-2

22.3.2 Shift Check.........................................................................................................................................................................................22-3

22.3.3 Automated Tests..............................................................................................................................................................................22-3

22.3.4 User Test .............................................................................................................................................................................................22-4

22.3.5 Recorder Inspection.......................................................................................................................................................................22-6

22.3.6 ECG Cable Test..................................................................................................................................................................................22-7

22.3.7 Manual Defibrillation Test............................................................................................................................................................22-7

22.3.8 Pacing Test.........................................................................................................................................................................................22-9

22.3.9 Peforming Testing in Installation Mode..................................................................................................................................22-9

22.3.10 NIBP Overpressure Protection Test......................................................................................................................................22-12

22.3.11 Electrical Safety Tests ...............................................................................................................................................................22-12

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

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

23.2 SpO2 Accessories...........................................................................................................................................................................................23-3

23.3 NIBP Accessories............................................................................................................................................................................................23-5

23.4 Therapy Accessories.....................................................................................................................................................................................23-5

23.5 Miscellaneous.................................................................................................................................................................................................23-6

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

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

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

A.3 Pacer Specifications .........................................................................................................................................................................................A-5

A.4 Monitor Specifications ....................................................................................................................................................................................A-5

A.5 Power Supply Specifications.........................................................................................................................................................................A-9

A.6 Recorder Specifications ...............................................................................................................................................................................A-10

7

A.7 Alarm Specifications......................................................................................................................................................................................A-10

A.8 Data Management Specifications ............................................................................................................................................................A-11

A.9 Environmental Specifications ....................................................................................................................................................................A-11

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

C BeneHeart Defibrillator Shift Checklist ..................................................................................................................... C-1

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

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

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

E Electrical Safety Inspection......................................................................................................................................... E-1

E.1 Power Cord Plug................................................................................................................................................................................................. E-1

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

E.3 Device Labelling.................................................................................................................................................................................................E-2

E.4 Protective Earth Resistance............................................................................................................................................................................E-2

E.5 Earth Leakage Test.............................................................................................................................................................................................E-2

E.6 Patient Leakage Current..................................................................................................................................................................................E-3

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

E.8 Patient Auxiliary Current.................................................................................................................................................................................E-4

F Symbols and Abbreviations........................................................................................................................................ F-1

F.1 Units ........................................................................................................................................................................................................................F-1

F.2 Symbols..................................................................................................................................................................................................................F-2

F.3 Abbreviations and Acronyms.........................................................................................................................................................................F-2

G Device Tracking ...........................................................................................................................................................G-1

8

FOR YOUR NOTES

1-1

1

Safety

1.1 Safety Information

DANGER

z

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

WARNING

z

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

CAUTION

z

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

product/property damage.

NOTE

z

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

1-2

1.1.1 Dangers

DANGER

z

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.

z

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

patient or metal devices connected to the patient during defibrillation.

z

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

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

z

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

WARNING

z

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.

z

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

necessary.

z

The equipment must be connected to a properly installed power outlet with protective earth contacts only.

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.

z

This equipment is used for single patient at a time.

z

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

during defibrillation.

z

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

z

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.

z

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

might be shocked.

z

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.

1-3

z

For the treatment of patients with implantable pacemakers, place therapy pads or paddles away from

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

z

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.

z

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.

z

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

z

Package material may contaminate the environment. Properly dispose of the package material according to

applicable waste control regulations and keep it out of children’s reach.

1.1.3 Cautions

CAUTION

z

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.

z

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.

z

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 devices are a possible source of

interference as they may emit higher levels of electromagnetic radiation.

z

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.

z

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

other mechanical force.

z

Dry the equipment immediately in case of rain.

z

Do not frequently charge the equipment and deliver shock in non-clinical situations. Otherwise equipment

damage could occur.

1.1.4 Notes

NOTE

z

Put the equipment in a location where you can easily see the screen and access the operating controls.

z

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

z

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

z

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

1-4

1.2 Equipment Symbols

Caution (Attention, consult

accompanying documents)

Status indicator

Alternating current

Battery indicator

Audio paused

Alarm off

Audio off

Alarm paused

Marker

Lead select

Gain select

Event summary

NIBP start/stop key

Graphical recorder

Menu

Unlocking

Network connector

Shock button

USB connector

Input/Output

Equipotentiality

Protective earth (ground)

Serial number

Dangerous voltage

1-5

Fragile

Right side up

Keep dry

Maximum stacks

Manufacturer

Date of manufacture

General symbol for recovery/recyclable

Electrostatic sensitive devices

Mark of conformity to European Medical Device Directive 93/42/EEC

Authorised representative in the European community

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

DEFIBRILLATION-PROOF TYPE BF APPLIED PART

Dispose of in accordance to your country’s requirements

1-6

FOR YOUR NOTES

2-1

2

The Basics

2.1 Overview

The BeneHeart (hereinafter called the equipment) is a lightweight and portable defibrillator/monitor. It provides four

operating modes: Monitor, Manual Defib, AED and Pacer.

In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing multiple

physiological parameters and waveforms including ECG, pulse oximetry (SpO

2

), respiration (Resp), and non-invasive

blood pressure (NIBP).

In 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.

In the Manual Defib Mode, the operator analyzes the patient’s ECG, and, if appropriate, follows 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 paddles or multifunction electrode pads. In Manual Defib Mode, you can also

perform synchronized cardioversion. If desired, use of Manual Defib Mode may be password protected.

The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction

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 an DC/AC

adapter may also be used as a power source and for continuous battery charging.

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-automatic defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG, SpO

2

, Resp, and

NIBP monitoring.

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.

2-2

2.2.1 AED

The AED mode is to be used only on cardio arrest patients who are at least 8 years. 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. Synchronous defibrillation 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 SpO

2

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

2.2.7 NIBP

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

2-3

2.3 Main Unit

2.3.1 Front View

Area 1

Alarm

lamp

Area 2

External paddle

Handle

Area 3

Microphone

Speaker

2-4

Area 1

1. Display screen

2. AC power indicator



Illuminated: when AC mains is connected.



Off: when AC mains is not connected.

3. Battery indicator



Yellow: when the battery is being charged.



Green: when the battery is fully charged or the equipment is run on battery.



Off: when no battery is installed or battery fails.

4. Status indicator (red cross)



Flashing: when a failure is detected or when battery is not installed if [No Battery] is configured as

[Status Indicator ON].

5. Status indicator (green tick)



Illuminated: when AC mains is connected, and the equipment operates properly.

NOTE

z

Both status indicators are off when AC mains is not connected if the equipment is turned off and no failure

is detected.

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.

1

2

3

4

5

6

2-5

Area 2

1. Lead Select button

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

2. Gain select button

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

3. NIBP button (for equipments configured with NIBP function)

Press this button to start or stop NIBP measurements.

Record button (for equipments without NIBP function)

Press this button to start a recording or stop the current recording.

4. Alarm Pause button

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

5. Mark Event button

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

6. 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.

7. Navigation knob

You can:



Rotate it clockwise or counterclockwise to move the cursor, or



Press it to confirm the selection.

2

3

5

7 6

4

1

2-6

Area 3

1. Mode Select knob

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

2. Energy Select button

In Manual Defib mode, press this button to select 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.

1

2

3

4

2-7

Recorder

1. Start/Stop Key

Press this key to start a recording or stop the current recording.

2. Indicator



Illuminated: when the recorder works correctly.



Flashes: when an error occurred to the recorder, or the recorder runs out of paper.

3. Paper outlet

4. Recorder door

5. Latch

3

4

2

1

5

2-8

2.3.2 Side View

Therapy port is used to connect paddles cable or pads cable.

1. Recorder

2. ECG: ECG cable connector

3. SpO

2

: SpO2 sensor connector

4. NIBP: NIBP cuff connector

Therapy port

1

2

4

3

2-9

2.3.3 Rear View

1. Hook

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. Multifunctional connector

It provides ECG output and defib synchronization input.

6. USB connector

7. Network connector

It is a standard RJ45 connector.

1

2

4

6

7

5

2-10

2.3.4 External Paddles

1. Shock button

2. Energy Select button

3. Shock indicator

4. Charge button

5. Shock button

1

2

4

5

3

Sternum paddle Apex paddle

2-11

2.4 Display Views

A typical screen in 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

indicates alarms are paused;

indicates all alarms are turned off;

indicates alarm sounds are paused;

indicates alarm sounds are turned off.

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 come, they will be

displayed circularly.

5. Battery Status indicator

It indicates battery status. Refer to 18 Battery for details.

1

2

3

4

5

6

7

2-12

6. Waveform area

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

waveform.

7. 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.

8. Manual Defib information area

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

9. Runtime area

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

10. Prompt area

This area shows the prompt information.

11. Soft Key area

The three soft key labels correspond to the soft key buttons located immediately below. The labels of the soft keys

changes according to the current display view and function. Soft key labels appearing as blank indicate that the

soft key is inactive.

3-1

3

Basic Operations and Settings

3.1 Installation

WARNING

z

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

z

The software copyright of the equipment is solely owned by the 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.

z

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 60601-1-1 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 60601-1-1. If you have any question, please contact the the manufacturer.

z

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.

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.

WARNING

z

Package material may contaminate the environment. Properly dispose of the package material according to

applicable waste control regulations and keep it out of children’s reach.

z

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.

NOTE

z

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

3-2

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.

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

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

NOTE

z

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

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

3.2 Basic Operation

3.2.1 Turning Power On

Once the equipment is installed, you can get ready for monitoring and therapy:

1. Before turning on the equipment, check for any mechanical damage and make sure that all external cables,

plug-ins and accessories are properly connected.

2. Plug the power cord into 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, an DC/AC adapter we supply should be used.

3. Turn the Mode Select knob to enter the desired working mode. After the start-up screen is displayed, the system

gives a beep, and meanwhile, the alarm lamp is illuminated in yellow, and then turns red, and then turns off.

4. The equipment enters the screen of selected mode.

WARNING

z

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

working properly, or if it is mechanically damaged. Contact your service personnel or us.

3.2.2 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.

Refer to the appropriate sections for details of how to perform patient monitoring and therapy.

3-3

3.2.3 Disconnecting from Power

To disconnect the equipment from the AC power source, follow this procedure:

1. Confirm 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.

3.2.4 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.

3.3 Using the Main Menu

To enter the main menu, press the Main Menu button on the equipment’s 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 to reveal more options or information.

3. Exit button

3.4 Changing General Settings

3.4.1 Setting the Date and Time

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

required password.

2. Select [General Setup >>].

3. Select [Date Format] from [yyyy-mm-dd], [mm-dd-yyyy] and [dd-mm-yyyy].

4. Select [Time Format] and toggle between [24h] and [12h].

5. Set [System Time].

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2

3

3-4

You can also set system time by selecting [Configuration >>]→[View Config]→[General Setup >>]. However, you

cannot select date format and time format in this case. After the completion of setting system time, exit the

configuration mode, and then the system will restart.

3.4.2 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 screen brightness by entering configuration mode and selecting [Others] from the Configuration

Main menu.

3.4.3 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 entering configuration mode and selecting [Others] from the Configuration Main

menu.

3.4.4 Selecting High Contrast Mode

The equipment has the function of high contrast display so that the user can view the display under high ambient

illumination.

To enable the High Contrast display,

 In the Monitor, Manual Defib and Pacer mode, press the Main Menu button on the front panel, and then select

[High Contrast]. To disable high contrast display, select [Full Color] in the Main Menu.

 In AED mode, press the [High Contrast] soft key. To disable high contrast display, press the [Full Color] soft key.

Once High Contrast is selected, the system remains in high contract mode when you change the operating mode.

However, the setting will not be saved if the equipment is turned off.

4-1

4

Managing Patients

4.1 Overview

Patient information management function enables you to edit and manage information of the current patient.

4.2 Editing Patient Information

You can edit patient information in Monitor, Manual Defib and Pacer mode.

To edit patient information,

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

changes as desired.

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

Archive ID is created automatically when the equipment is turned on. It is unchangeable. When the equipment is turned

off, the current patient is discharged and the archive ID turns to be historical archive ID

For a new patient, if patient category is changed, the system will restore the default alarm settings of this patient

category; if patient category is not changed, the alarm settings remain unchanged. If you restart the equipment after

normal power-off, the default alarm settings will be loaded.

4-2

FOR YOUR NOTES

5-1

5

Alarms

Alarms, triggered by a vital sign that appears abnormal or by technical problems of the equipment, are indicated to the

user by visual and audible alarm indications.

WARNING

z

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.

5.1 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 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.

5-2

5.2 Alarm Levels

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

Physiological alarms Technical alarms

High level

Indicate that your patient is in a life

threatening situation, such as Asystole,

Vfib/Vtac and so forth, and an

emergency treatment is demanded.

Indicate a severe device malfunction or an improper operation,

which could make it possible 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.

Indicate a device malfunction or an improper operation, which

may not threaten the patient’s life but may compromise patient

monitoring or therapy.

Low level

Indicate that you patient’s vital signs

appear abnormal and an immediate

treatment may be required.

Indicate a device malfunction or an improper operation, which

may compromise a certain function but will not threaten the

patient’s life.

5.3 Alarm Indicators

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

 Alarm lamp
 Alarm tones
 Alarm message
 Flashing numeric

NOTE

z

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.

z

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.

5.3.1 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.
 Medium level alarms the lamp slowly flashes yellow.
 Low level alarms the lamp lights yellow without flashing.

5-3

5.3.2 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.

5.3.3 Alarm Message

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 *

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

For technical alarms

 High level alarms: red
 Medium level alarms: yellow
 Low level alarms: blue

5.3.4 Flashing Numeric

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.

5.3.5 Alarm Status Symbols

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



indicates all alarms are paused.

 indicates all system alarms are turned off.



indicates alarm sounds are paused.



indicates alarm sounds are turned off.

5-4

5.4 Alarm Tone Configuration

5.4.1 Changing the Alarm Volume

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

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.

To disable or enable [Audio Off], access configuration management.

The setting of alarm volume will not be saved when the system is power off.

You can also set alarm volume in configuration mode. In this case, the setting will be saved.

NOTE

z

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

5.4.2 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 >>] to enter the [Alarm Setup] menu.

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

WARNING

z

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

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

5.5 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.

5-5

5.5.1 Setting Alarm Properties for All Parameters

In the main menu, select [Alarm Setup >>][→ Para. Alarm >>] to enter the Para. Alarm setup 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.

 If 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.

To reset the default settings, select the [Defaults] button.

NOTE

z

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.

You can also set parameter alarm properties by selecting a parameter window and select [Para. Alarm >>] in the

pop-up menu.

WARNING

z

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

z

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 SpO

2

high alarm limit to 100%, which is equivalent to switching the alarm off.

5-6

5.5.2 Adjusting Alarm Limits Automatically

The defibrillator/monitor 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 equipment’s front panel, and then select [Alarm Setup

>>][→ Para. Alarm>>][→ Auto Limits].

You can also access [Auto Limits] by select a parameter window to enter the [Para. Alarm] menu.

When auto alarm limits have been applied, you can manually adjust the alarm limits through the Para. Alarm Setup

menu so that they are appropriate for your patient.

The defibrillator/monitor calculates the auto limits based on the following rules.

Low alarm limit High alarm limit

Module Parameter

Adult/

pediatric

Neonate

Adult/

pediatric

Neonate

Auto alarm limits

range

ECG HR

HR×0.8 or 40 bpm

(whichever is

greater)

(HR-30) or 90 bpm

(whichever is

greater)

HR×1.25 or 240

bpm whichever is

lower)

(HR + 40) or 200

bpm whichever is

lower)

Adult/pediatric: 35 to

240

Neonate: 55 to 225

Resp RR

RR×0.5 or 6/min

(whichever is

greater)

(RR-10) or 30/min

(whichever is

greater)

RR×1.5 or 30/min

(whichever is

lower)

(RR+25) or 85/min

(whichever is

lower)

Adult/pediatric:

6 to 55

Neonate: 10 to 90

SpO2

Same as the

default alarm limit

Same as the

default alarm limit

Same as the

default alarm limit

Same as the default

alarm limit

Same as the

measurement range

SpO2

PR

PR×0.8 or 40 bpm

(whichever is

greater)

(PR-30) or 90 bpm

(whichever is

greater)

PR×1.25 or 240

bpm whichever is

lower)

(PR + 40) or 200

bpm whichever is

lower)

Adult/pediatric: 35 to

240

Neonate: 55 to 225

NIBP-S

SYS × 0.68 + 10

mmHg

(SYS-15) or 45

mmHg (whichever

is greater)

SYS × 0.86 + 38

mmHg

(SYS + 15) or 105

mmHg (whichever

is lower)

Adult: 45 to 270

Pediatric: 45 to 185

Neonate: 35 to 115

NIBP-D

Dia × 0.68 + 6

mmHg

(Dia-15) or 20

mmHg (whichever

is greater)

Dia × 0.86 + 32

mmHg

(Dia + 15) or 80

mmHg (whichever

is lower)

Adult: 25 to 225

Pediatric: 25 to 150

Neonate: 20 to 90

NIBP

NIBP-M

Mean × 0.68 + 8

mmHg

(Mean-15) or 35

mmHg (whichever

is greater)

Mean × 0.86 + 35

mmHg

(Mean + 15) or 95

mmHg (whichever

is lower)

Adult: 30 to 245

Pediatric: 30 to 180

Neonate: 25 to 105

NOTE

z

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

limits range.

5-7

5.6 Pausing Alarms

You can temporarily disable alarm indicators by pressing the hardkey on the equipment’s front. 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.

 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

hardkey.

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.

5.7 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

hardkey is pressed if the [Alarm Pause Time] is set to [Permanent].

 The equipment is switched to the Manual Defib mode. Or
 The equipment exit synchronous defibrillation when operating in the Manual Defib mode.

The alarm off status is exited when,

 The

hardkey is pressed, or

 Sync Defib is switched on in Manual Defib mode.

5-8

5.8 Pausing Alarm Sounds

You can press the [Audio Pause] softkey to pause alarm tones. In this case, the symbol will be displayed in the

sound symbol area indicating all system sounds are silenced temporarily. In the audio paused status, all alarm indicators

except audible alarm tones works properly. If alarms are switched off or paused, the [ Audio Pause] soft key is not

shown.

The audio paused status is exited when,

 The [ Audio On] soft key is pressed.
 Other alarms occur. Or

 The

hardkey is pressed to permanently or temporarily switch off the alarms.

5.9 Switching Off Alarm Sounds

In the event that [Audio Off] is enabled, to switch off the alarm tone, set [Alm Volume] to 0 while operating in Monitor

mode, Manual Defib mode or Pacer mode. In the audio off status, 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:

 The

hardkey is pressed. In this case, the equipment enters the alarm paused status and the alarm volume is

reset to the default level. The symbol

is displayed in the sound symbol area.

 The [Audio Pause] soft key is pressed. In this case, the equipment enters the audio paused status and the alarm

volume is reset to the default level. The symbol

is displayed in the sound symbol area.

 Operating mode is switched. Then the equipment enters the default alarm status of corresponding operating mode.

Or

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

5.10 Reminder Tones

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

The reminder tone is switched off by default. You can switch it on by selecting [Alarm Setup]→[Reminder Tone]

through the Configuration Management Main menu. You can also change reminder volume. The default reminder

volume is [Med].

5-9

5.11 Latching Alarms

The latching setting for physiological alarms defines how alarm indicators behave when you do not acknowledge them.

 If an alarm is latched, alarm indications remain presented even though alarm conditions end, except that:



The parameter reading and violated alarm limit stop flashing.



The time when the alarm 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 [Yes].

Only physiological alarms can be latched.

You can clear the latched alarms by pressing the

hardkey.

5.12 Clearing Technical Alarms

For some technical alarms, their alarm lamp flashing and alarm tones are cleared and the alarm messages change to

prompt messages after the

hardkey or [Audio Pause] 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.

For some technical alarms, all their alarm indications are cleared after the

hardkey or [Audio Pause] 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.

For others, their alarm tones are cleared but the alarm lamp flashing and alarm messages remain after the

hardkey

or [Audio Pause] soft key is pressed. After the equipment restores the normal alarm status, all the alarm indications will

continue if the alarm conditions still present.

5-10

5.13 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, see Appendix D Alarm Messages.

6-1

6

Monitoring ECG

6.1 Overview

The electrocardiogram (ECG) measures the electrical activity of the heart and displays it as waveforms and numerics. The

equipment enables ECG monitoring through 3-, 5- lead ECG sets, external paddles and multifunction electrode pads. If

both ECG sets and paddles/pads are connected, the configured ECG waveforms are displayed in the waveform area.

6.2 Safety

WARNING

z

Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace

the electrodes or change the application site.

z

Use defibrillation-proof ECG cables during defibrillation.

z

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

the pacing 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.

NOTE

z

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.

z

Interference from a non-grounded instrument near the patient and electrosurgery interference may cause

problems with the waveform.

z

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

z

Avoid using external paddles for ECG monitoring if possible.

z

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

6-2

6.3 Monitoring View

You can access Monitor mode by switching the Mode Select knob to the Monitor position. When operating in Monitor

mode, the equipment displays up to two ECG waveforms, the heart rate reading, other available parameter values and

active alarm settings.

6.4 Preparing to Monitor ECG

6.4.1 ECG Monitoring with Electrodes

1. Prepare the patient’s 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:



Shave hair from skin at chosen sites.



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



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.



Dry the skin completely before applying the electrodes.

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

3. Place the electrodes on the patient.

4. Attach the lead wires to the ECG trunk cable and then plug the trunk cable into the equipment’s ECG connector.

5. Connect the ECG trunk cable to the equipment.

6. Switch the Mode Select knob to Monitor.

6.4.1.1 Placing Electrodes

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.

6-3

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 open-chest

surgery, the chest electrodes can be placed on the lateral chest or back. To reduce artifacts and interference from

electrosurgical units, you can place the limb electrodes close to the shoulders and lower abdomen and the chest

electrodes on the left side of the mid-chest. Do not place the electrodes on the upper arm. Otherwise, the ECG

waveform will be very small.

WARNING

z

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

prevent unwanted burns. Never entangle ESU cable and ECG cable together.

z

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.

6-4

6.4.2 ECG Monitoring with Paddles/Pads

1. Prepare the patient’s skin.

2. Apply the paddles/pads to the patient.



If multifunction electrode pads are used, apply pads according to the instructions for use indicated on pads

package. Use anterior-lateral placement.



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 paddle electrodes. Place the paddles to the patient’s chest using the

anterior-lateral placement.

3. If multifunction electrode pads are used, connect the pads to the pads cable.

4. Connect paddles/pads cable with the equipment if not connected.

Anterior-lateral Paddles/Pads placement

1. Place the RA pad or Sternum paddle on the patient’s upper right torso, lateral to the sternum and below the clavicle,

as shown below.

2. Place the LL pad, or Apex paddle to the patient’s left nipple in the midaxillary line, with the center of the electrode

in the midaxillary line, if possible. See the figure below.

NOTE

z

Anterior - lateral placement is the only placement that can be used for ECG monitoring with paddles/pads

accessories.

LL

RA

Apex paddle

Sternum

paddle

6-5

6.4.3 Checking Paced Status

It is important to set the paced status correctly when you start monitoring ECG. The paced symbol is displayed in

the patient information area 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, you can select either:

 [Main Menu][→ Patient Demographics >>][→ Paced], or
 The ECG parameter window to enter the [ECG Setup] menu, and then, select [Others >>][→ Paced],

and toggle between [Ye s ] and [No].

Warning

z

For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the patient monitor 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.

z

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).

6.5 ECG Display

The figure below shows the ECG monitoring view in 5-lead mode. It is for reference only. Your display may be configured

to look slightly different.

PVCs values is shown only when arrhythmia analysis is switched on. When external paddles or multifunctional electrode

pads are used for ECG monitoring, the PVCs values is shown as “---”.

Lead label

Gain

Filter mode

Alarm limits

HR value

Heartbeat icon

PVC values

6-6

6.6 Changing ECG Settings

6.6.1 Changing Lead Settings

6.6.1.1 Selecting 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 in the configuration mode:

1. Press the Menu button on the equipment’s front panel. In the Main Menu, select [Others >>][→ Configuration

>>]→enter the required password to enter the Configuration Main menu.

2. Select [ECG Setup][→ Lead Set] and toggle between [3-lead] and [5-lead].

6.6.1.2 Choosing AHA or IEC Lead Placement

1. Select [Main Menu][→ Others >>][→ Configuration >>]→enter the required password.

2. In the Configuration Main menu, select [ECG Setup][→ ECG Standard], and then select [AHA] or [IEC] according to

the standard that is applied to your hospital.

6.6.1.3 Choosing the Heart Rate Source

To compute heart rate and to detect and analyse arrhythmia more accurately, you can choose a lead of best quality

signals as the HR calculation lead. To do so, select [ECG1] from the [ECG Setup] menu and then select the lead you want.

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.

6-7

6.6.2 Changing ECG Wave Settings

You can select the ECG parameter area to enter the [ECG Setup] menu to set ECG cascade and wave speed. You can also

select the hot keys above the ECG waveform to change ECG lead, size and filter.



You can press the Lead Select button on the equipment’s front panel or use the Navigation knob to select the

lead hot key above the first ECG waveform to select a lead.

 If the wave is too small or clipped, you can change its size by adjusting the gain select button on the front panel or

selecting the Size hot key above the ECG waveform.

 When monitoring ECG through ECG lead set, filter mode is displayed above the first ECG waveform. The available

filter mode settings are [Monitor], [Therapy], and [Diagnostic]. The default is [Therapy]. To change filter mode,

select the filter mode hot key using the Navigation knob.



When monitoring ECG through pads/paddles, filter mode is always “Therapy” and is not shown..

 In the [ECG Setup] menu, select [Sweep], and then choose an appropriate value. The faster the wave sweeps, the

wider the wave is. You can also access [Sweep] to adjust wave speed from the [ECG Setup] menu in the

Configuration mode.

 In the [ECG Setup] menu, select [ECG Cascade] and toggle between [On] and [Off].

NOTE

z

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.

6.6.3 Switching the Notch Filter On or Off

The notch filter removes the AC line noise. When [Filter] is set to [Monitor] or [Therapy], the notch filter is always on.

When [Filter] is set to [Diagnostic], you can switch the notch filter on or off as required.

To switch on or off notch filter, select the ECG parameter area to enter the [ECG Setup] menu, and then select [Others

>>][→ Notch Filter] and toggle between [On] and [Off].

Switching on the notch filter is recommended when there is interference with the waveform.

Set notch frequency according to the electric power frequency of your country. Follow this procedure:

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

required password.

2. Select [ECG Setup][→ Notch Filter] and then select [50Hz] or [60Hz] according to the power frequency.

6-8

6.6.4 Adjusting Heartbeat Volume

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,

 Select the ECG parameter window to enter the [ECG Setup] menu, and then select [Others >>][→ QRS Volume], or
 From the Configuration Main menu, select [ECG Setup] [→ QRS Volume],

and then select an appropriate setting. The heartbeat volume can be set between 0 and 10, in which 0 means off, and 10

is the maximum volume.

When a valid SpO

2

value exists, the system will adjust the pitch of the heartbeat tone according to the SpO2 value.

6.7 Arrhythmia Analysis

Arrhythmia analysis provides information about your patient’s condition, including heart rate and arrhythmia alarms.

NOTE

z

Arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial

or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia.

Therefore, a physician must analyze the arrhythmia information with other clinical findings.

z

The arrhythmia detection is not intended for neonatal patients.

6.7.1 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.

Vtac 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

PVCs/min PVCs/min exceeds high limit

PNP** No pace pulse detected for 1.75 x average R-to-R intervals following a QRS

complex (for paced patients only).

PNC** No QRS complex detected for 300 milliseconds following a pace pulse (for

paced patients only).

PVC One PVC detected in normal heartbeats.

Couplet Paired PVCs are detected.

VT>2 More than 2 consecutive PVCs within the last minute.

Nonlethal

arrhythmia

6-9

Arrhythmia event Description Category

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 Beats* No beat detected for 1.75x average R-R interval for HR <120, or No beat for 1

second with HR >120 (for non-paced patients only), or No beat detected for

more than the set pause threshold.

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 Rate

limit and the Vtac Rate limit.

Multif. PVC 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 Rate

limit.

Pause* No QRS detected within the set time threshold of pause.

Irr. Rhythm Consistently irregular rhythm.

*: indicates that this arrhythmia alarm is not presented when [Paced] is set to [Yes ].

**: indicates that this arrhythmia alarm is not presented when [Paced] is set to [No].

 When multifunctional electrode pads are used for ECG monitoring, the equipment provides only 4 arrhythmia

alarms, including asystole, ventricular fibrillation/ventricular tachycardia, PNP, and PNC.

 When paddles are used, the equipment provides only 3 arrhythmia alarms, including ventricular

fibrillation/ventricular tachycardia, PNP, and PNC.

6.7.2 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. Select [Arrhythmia >>].

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

You can also switch arrhythmia analysis on or off in the Configuration mode. Follow this procedure: Enter the

Configuration Main menu. Select [ECG Setup][→ Arrhythmia] and toggle between [On] and [Off].

6-10

6.7.3 Changing Arrhythmia Alarm Settings

To change arrhythmia alarm settings, select the ECG parameter area to enter the [ECG Setup] menu, and then select

[Arrhythmia >>]→[Arrh. Alarm] menu, where you can set alarm switch, alarm level and alarm record switch for all the

arrhythmia events..

You can also set arrhythmia alarm properties in the Configuration mode through the ECG Setup menu.

NOTE

z

The alarm level for asystole, ventricular fibrillation, ventricular tachycardia, ventricular bradycardia,

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.

6.7.4 Changing Arrhythmia Threshold Settings

To change arrhythmia threshold settings, select the ECG parameter window→[Arrhythmia >>]→[Arrh. Threshold >>].

In case an arrhythmia violates its threshold, an alarm will be triggered. The setting of Asystole Delay is linked 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 2 to 10 5 1 s

Tachy 60 to 300 Adult: 120

Pediatric: 160

5 bpm

Brady 15 to 120 Adult: 50

Pediatric: 75

5 bpm

Extreme Tachy 60 to 300 Adult: 160

Pediatric: 180

5 bpm

Extreme Brady 15 to 120 Adult: 35

Pediatric: 50

5 bpm

Multif. PVCs Window 3 to 31 15 1 Beats

V-Tach Rate 100 to 200 130 5 bpm

V-Tach PVCs 3 to 12 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 from the ECG Setup menu in the configuration mode.

6-11

6.7.5 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 to manually initiate arrhythmia relearning when you suspect the result of arrhythmia

analysis.

To initiate relearning manually, select the ECG parameter window to enter the [ECG Setup] menu, select [Arrhythmia

>>][→ Relearn Arrh.]. When the equipment is learning, the message “Learning ECG” is displayed in the technical alarm

area.

NOTE

z

Arrhythmia relearning in the case of ventricular tachycardia may affect correct arrhythmia alarm.

6.7.6 Automatic Arrhythmia Relearn

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.

6.8 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. Select ECG filter hot key. Turn the navigation knob to select [Diagnostic] mode.

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

3. Select [Others >>][→ Calibrate]. In this case, a square wave appears on the screen and the message “Calibrating

ECG” is displayed.

4. Compare the amplitude of the square wave with the 1 mV wave scale. The difference should be within 5%.

5. 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.

6-12

FOR YOUR NOTES

7-1

7

AED

7.1 Overview

This chapter describes how to operate the equipment in AED Mode. While operating in AED Mode, the equipment

analyses the patient’s ECG waveforms and guides you through the defibrillation process.

The equipment starts analyzing the patient’s heart rhythm immediately after entering 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 pads connection occurs.

While operating in AED Mode, the capabilities of the device are limited to those essential to the performance of

semi-automated external defibrillation. Only ECG signals acquired through pads are displayed. Previously set alarms and

scheduled measurements are indefinitely paused and entry of patient information is disabled. Additionally, the Lead

Select, Alarm Pause, and Main Menu buttons are inactive.

7.2 Safety

DANGER

z

Defibrillation current can cause operator or bystander severe injury or even death. Never touch the patient

or any equipment connected to the patient (including the bed or gurney) during defibrillation.

z

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.

z

Do not allow multifunction 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.

z

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.

7-2

WARNING

z

During defibrillation, air pockets between the skin and multifunction electrode pads can cause patient skin

burns. To help prevent air pockets, make sure defibrillation pads are completely adhered to the skin.

z

Do not use dried-out pads.

z

In AED mode, this equipment is not designed to administer energy at pediatric joule settings. The American

Heart Association recommends AEDs be used only on patients who are more than eight years old.

CAUTION

z

Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads. Discard

the pads if they become damaged.

z

For patients with implantable pacemaker, the sensitivity and specificity of AED algorithm may be impaired.

7.3 AED View

A typical screen in AED Mode is shown below.

In AED mode, HR numeric and one ECG waveform acquired from the multifunction electrode pads are displayed. Below

the ECG is the information area which displays the defibrillation mode, prompt message, contact impedance indicator,,

selected energy and a shock counter.

For details about the contact impedance indicator, refer to 8.7 Contact Impedance Indicator.

7-3

7.4 AED Procedure

Confirm that the patient is unresponsive, not breathing or not breathing normally.

Then:

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. Apply multifunction electrode pads to the patient as directed on the pads package. Use anterior-lateral placement.

3. Connect the pads with pads cable, and then plug the pads cable in the equipment’s therapy port.

4. Turn the Mode Select knob to AED.

When the equipment enters AED mode, it checks to see if the 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.

5. Follow the screen and voice prompts.

Once an ECG is detected through the multifunction 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/off the voice prompt by accessing configuration management or adjust the volume of the voice

prompts by pressing the voice volume soft key.

6. Press the Shock button, if prompted.

Once charging is complete, 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.

Delivery of the shock is confirmed by the voice and screen prompt "Shock Delivered" and the shock counter on the

display is updated to reflect the number of shocks given. If 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.

NOTE

z

Do not use anterior-posterior pads placement (multifunction electrode pads placed on the patient’s chest

and back). The AED algorithm used by the equipment has not been validated using this placement.

z

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.

z

The Shock button must be pressed to deliver a shock. The equipment will not automatically deliver a shock.

z

Impedance is the resistance between the defibrillator’s pads or paddles that the defibrillator must

7-4

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 washed and dried and that any chest hair has been clipped. If the message persists,

change the pads and/or the pads cable.

7.5 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.

For defibrillation of adult patients, recommended energy level is 200 Joules.

7.6 No Shock Advised (NSA)

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 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. The pause period can be defined by setting [CPR Time]

through configuration management.

Analysis resumes at the completion of the pause period or when you press the [Resume Analyzing] soft key in 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 can define the frequency of these prompts by adjusting [Voice Prompts Interval] through configuration

management. You may press the [Pause for CPR] soft key to suspend monitoring and administer CPR. The pause

period can be defined by setting [CPR Time] through configuration management.

7-5

7.7 CPR

If [Initial CPR Time] is not configured as Off, the system enters initial CPR if AED mode is entered. You can set [Initial

CPR Time] to an appropriate time or switch it off through configuration management.

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 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. The CPR pause time is defined by setting [CPR Time] through configuration management.

NOTE

z

You can start analyzing patient’s heart rhythm again at any time by pressing the [Resume Analyzing] soft

key in CPR status.

7.7.1 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 120 times per minute and give voice prompts to indicate the rescuers to

perform ventilation at configured compression/ventilation rate.

To activate or deactivate CPR metronome,

1. Move the Mode Select knob to Monitor, Manual Defib or Pacer. Press the Main Menu button on the front panel, and

then select→ [Others >>]→[Configuration >>]→Enter the required password.

2. Select [AED Setup] [→ CPR Metronome], and toggle between [On] and [Off].

The CPR metronome is activated by default. When CPR metronome is on, you can set the compression/ventilation rate

by selecting [CPR Mode]. The default rate is 30:2.

7-6

Warning

z

The CPR metronome sounds do not indicate information regarding the patient’s condition. Because 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.

NOTE

z

CPR metronome and its volume is affected by the settings of [Voice Prompt] and [Voice Volume] in the AED

Setup menu.

7.8 AED Sound Recording

The equipment include a sound recording fucntion 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. Move the Mode Select knob to Monitor, Manual Defib or Pacer. Press the Main Menu button on the front panel, and

then select [Others >>]→[Configuration >>]→Enter the required password.

2. Select [AED Setup] [→ Voice Recording], and toggle between [On] and [Off].

The symbol

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.

7.9 AED Setup

1. Move the Mode Select knob to Monitor, Manual Defib or Pacer. Press the Main Menu button on the front panel, and

then select [Others >>]→[Configuration >>]→Enter the required password.

2. Select [AED Setup >>] to enter the AED Setup menu, and then change AED settings as desired.

Refer to Section 19.3.3 AED Setup Menu for details.

8-1

8

Manual Defibrillation

8.1 Overview

This chapter explains how to prepare for and perform asynchronous defibrillation and synchronous cardioversion using

multifunction electrode pads and external paddles.

In 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 SpO

2.

.

Alarms are turned off automatically when you enter Manual Defib mode. Pressing the Alarm Pause button can turn on

the alarms.

8.2 Safety

DANGER

z

Defibrillation current can cause operator or bystander severe injury or even death. Never touch the patient

or any equipment connected to the patient (including the bed or gurney) during defibrillation.

z

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.

z

Do not allow multifunction 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.

z

During manual defibrillation, make sure your hands are dry and free from conductive gel to avoid shock

hazard.

z

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.

8-2

WARNING

z

During synchronous cardioversion, if monitoring patient’s ECG through external paddles, artifact

introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock.

z

Do not use conductive liquid. Use only conductive gel specified by the equipment manufacturer.

z

If external paddles are used for defibrillation, apply the paddles tightly and evenly to the patient’s chest to

ensure good skin contact.

z

Never apply the paddles to human body to verify paddle connection.

z

Clinicians must select an appropriate energy level for defibrillation of pediatric patients.

CAUTION

z

Use of Manual Defib 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 manual

defibrillation therapy.

z

Clear the conductive gel from the external paddles at the completion of the therapy to prevent the paddles

from being corroded.

z

Prior to using this defibrillator, disconnect from the patient all equipment that is not defibrillator-protected.

z

Do not charge the equipment and deliver shock frequently in non-clinical situations. Otherwise equipment

damage could occur.

NOTE

z

Impedance is the resistance between the defibrillator’s pads or 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 washed and dried and that any chest hair has been clipped. If the message persists,

change the pads and/or the pads cable.

z

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 is entered, or the Mode Select knob is moved to Monitor or Pacer.

8-3

8.3 Manual Defibrillation View

A typical screen in Manual Defib Mode is shown below.

In the enlarged ECG area, an ECG waveform and related parameters are displayed. In the middle of the screen,

defibrillation mode, synchronous icon, prompt message, selected energy, contact impedance indicator, and a shock

counter are displayed.

8.4 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. Connect the therapy cable to the therapy port. Push until you hear it click into place.

3. Apply multifunction electrode pads or external paddles to the patient.



If multifunction electrode pads are used, apply pads according to the instructions for use indicated on pads

package. Use anterior-lateral or anterior-posterior placement.



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 paddles to the

patient’s chest using the anterior-lateral placement.

Do not touch this surface and the

part below.

8-4

WARNING

z

Hold only the insulating parts of the paddle handles to avoid shock hazard during charging or shock

delivery.

4. Turn the Mode Select knob to Manual Defib.

You can access manual therapy directly, by confirmation or by password, which can be defined through

configuration management. The default setting is [Direct].



If [Manual Therapy Access] is set to [Direct], the equipment directly enters Manual Defib mode when the

Mode Select knob is switched to Manual Defib.



If [Manual Therapy Access] is set to [Confirmed], a dialog box pops up when the Mode Select knob is

switched to Manual Defib. You have to confirm whether to enter Manual Defib mode or not.



If [Manual Therapy Access] is set to [Password], a dialog box pops up, requiring the user to enter a password,

when the Mode Select knob is switched to Manual Defib. The equipment enters Manual Defib mode only after

correct password is entered.

5. Select energy.

You can select desired energy level by the adjusting the Energy Select buttons on the equipment’s front panel or

the Energy Select buttons on external paddles if external paddles are used.

Your current energy selection is shown in the defibrillation information area as shown below.

6. 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 complete, 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 define [Time to Auto Disarm] through configuration management.

7. 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 loudly and clearly, “Stay

Clear!”



If 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.

8-5

NOTE

z

Defibrillation is always performed through paddles or 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.

z

When external paddles are used, the Shock button on the equipment’s front panel is disabled.

z

For defibrillation of adult patients, recommended energy level is 200 Joules.

8.4.1 Using Pediatric Paddles

The external paddle set comes with pediatric paddles included. To use the pediatric paddle set, depress the latch at the

front of the external paddle set while pulling forward on the adult paddle electrodes.

To defibrillate, refer to the procedure as described in Section 8.4 Manual Defibrillation Procedure.

8.4.2 Using Internal Paddles

To defibrillate using internal paddles:

1. Turn on the defibrillator and enter the manual defib mode.

2. Select the appropriate paddle size.

3. Connect the paddles to the defibrillator by aligning the white pointer on the paddles cable with the arrow on the

therapy port. Push until you hear it click into place.

4. Select energy by pressing the Energy Select key on the equipment's front panel.

5. Place the conductive surface of paddle electrodes against the patient's right atrium and left ventricle, as shown in

the figure below:

6. Charge the defibrillator by pressing the Charge key on the front panel.

7. Make sure no one is touching the patient or anything connected to the patient.

8. Press the Shock key on the front panel.

Using internal paddles for synchronized cardioversion requires that the patient’s ECG be acquired 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 R-wave detection.

8-6

NOTE

z

When internal paddles are used for defibrillation, the energy selection is automatically limited to 50 joules

because of possible cardiac damage from higher energies.

z

Sterilize the internal paddles before each use. Otherwise, severe infection may result.

z

Clean the internal paddles after each use.

8.5 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 either:

 Multifunction electrode pads, or
 External 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 multifunction electric pads, or external paddles, or electrodes connected to a 3- or 5-lead

ECG cable. Shock is delivered through either pads or paddles.For synchronized cardioversion, we recommend to acquire

patient’s ECG through ECG lead set

NOTE

z

When you enter synchronous cardioversion, monitoring alarms is reactivated autonomously.

Sync marker

R-wave marker

8-7

8.5.1 Performing Synchronized Cardioversion

1. Connect the therapy cable and apply the multifunction 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, referring to 6

Monitoring ECG.

2. With the Mode Select knob in the Manual Defib position, press the [Enter Sync] soft key to activate the

synchronous 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 the equipment enters the Sync mode, as indicated by the SYNC mark 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’s front panel or, 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.

NOTE

z

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.

8.5.2 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 above.

If [Sync after Shock] is set to [Ye s ], 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.

8.5.3 Disabling the Sync Function

To switch off the Sync function, press the [Sync Off] soft key to enter the Manual Defib mode. .

8-8

8.6 Remote Synchronized Cardioversion

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 defibrillator/monitor’s multifunctional connector with a synchronous cable.

To switch on remote synchronization, select [Manual Defib Setup]→[Remote Sync]→[On] through the Configuration

Main Menu.

The remote synchronization procedure is as follows:

1. Use a sync cable to connect the defibrillator/monitor with a bedside monitor through the defibrillator/monitor’s

multifunctional connector.

2. Switch on the equipment and enter the Manual Defib mode.

3. Press the [Enter Sync] soft key. In this case the “Select Sync Mode” dialog pops up.

4. Select [Remote] to enter remote synchronization. Then the message “Remote Sync” is presented.

5. Confirm a square wave on the defibrillator/monitor 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 click into place.

7. Apply multifunction electrode pads or external paddles to the patient.

8. Follow Steps 6 through 9 from 8.5.1 Performing Synchronized Cardioversion as described previously.

8-9

NOTE

z

During remote synchronous defibrillation, the local defibrillator/monitor does not display the ECG

waveform. To view the patient’s ECG, check the remote monitor.

z

When you use an remote monitor as the ECG source, a biomedical technician must verify that the remote

monitor and the defibrillator/monitor combination will deliver a synchronized shock within 60 ms of the

peak of the R-wave.

8.7 Contact Impedance Indicator

Contact impedance indicator is used to indicate the impedance between the defibrillator’s pads or paddles in Manual

Defib or AED mode, as shown below:

Different levels of the measured impedance are shown as follows:

 indicates the impedance is in normal range.



indicates the impedance is slightly higher for the defibrillation.



indicates the impedance is too high for the defibrillation or the pads or paddles are not

properly connected to the patient.



indicates the therapy cable is not properly connected.

To switch on the contact impedance indicator:

1. In Monitor, Manual Defib or Pacer mode, press the Main Menu button on the front panel, and then select→

[Others >>]→[Configuration >>]→Enter the required password.

2. Select [Manual Defibrillation] and set [Contact Impedance Indicator] to [On].

WARNING

z

It is recommended to perform defibrillation on a patient when the contact impedance is in normal range.

However, you can also perform defibrillation when the contact impedance is slightly higher.

Contact Impedance

Indicator

8-10

FOR YOUR NOTES

9-1

9

Noninvasive Pacing

9.1 Overview

In pacer mode, the patient’s ECG is monitored through ECG lead set and pace pulses are delivered through multifunction

electrode pads. The pads cannot be used to monitoring ECG rhythm and deliver pacing current at the same time.

A white pacing marker is shown on the ECG waveform each time a pacer 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, both ECG and SpO

2

parameters 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 multifunction electrode pads. However, the pads cannot be used to monitor the ECG and deliver pace

pulses simultaneously.

NOTE

z

In Pacer mode, arrhythmia analysis is supported and available arrhythmia alarms are asystole, ventricular

vibrillation and ventricular tachycardia.

9.2 Safety

WARNING

z

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.

z

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 multifunction electrode pads.

9-2

CAUTION

z

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.

z

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

z

Prolonged noninvasive pacing may cause patient skin irritation and burns. Periodically inspect the

underlying skin and change ECG electrodes and multifunction electrode pads.

NOTE

z

If pacing is interrupted for any reason, the [Start Pacing] soft key must be pressed to resume pacing.

z

In pacer mode, you cannot change the patient’s internal paced status from the ECG Setup menu.

z

In the case that pads poorly contact the patient, the alarm “Pacer Stopped Abnormally” and “Pads Off” may

be presented.

z

Pads are not an available choice for the source of ECG waveform in Pacer mode.

9.3 Pacing View

A typical screen in pacer Mode is shown below.

In pacer mode, an ECG waveform, related parameters and waveforms are displayed. The pacer information area shows

the pacer mode, pacer rate and output, as well as pacer-related prompts and alarms. Soft keys available for setting

pacing functions are also displayed.

9-3

9.4 Demand Mode versus Fixed Mode

The equipment can deliver paced pulses in either demand or fixed mode.

 In demand mode, the pacer only delivers paced pulses when the patient’s heart rate is lower than the selected

pacing rate.

 In fixed mode, the pacer delivers paced pulses at the selected rate.

During pacing, you can change pacer mode. Then the equipment continues to deliver pace pulses at selected pacer rate

and pacer output.

CAUTION

z

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.

z

During fixed mode pacing, R-wave markers do not appear on the paced beats.

z

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, pacing markers do not appear.

9.5 Preparing for Pacing

1. If not pre-connected, connect the pads cable to the equipment. Then push until you hear it click into place.

2. Make sure the multifunction electrode pads packaging is intact and within the expiration date shown.

3. Connect the pads connector to the pads cable.

4. Apply the pads to the patient using anterior-lateral or anterior-posterior placement.

5. 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. Refer

to 6.4.1 ECG Monitoring with Electrodes.

9-4

9.5.1 Demand Mode Pacing

To pace in demand mode:

1. Turn the Mode Select knob to the Pacer position. 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 access manual therapy directly, by confirmation or by password, which can be defined through

configuration management. The default setting is [Direct].



If [Manual Therapy Access] is set to [Direct], the equipment directly enters Pacer mode when the Mode Select

knob is switched to Pacer.



If [Manual Therapy Access] is set to [Confirmed], a dialog box pops up when the Mode Select knob is

switched to Pacer. You have to confirm whether to enter Pacer mode or not.



If [Manual Therapy Access] is set to [Password], a dialog box pops up, requiring the user to enter a password,

when the Mode Select knob is switched to Pacer. The equipment enters Pacer mode only after correct

password is entered.

2. Select a lead with an easily detectable R-wave.

3. Verify that white R-wave markers appear above the R-waves, as shown in the figure below. 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. Select pacer rate. If necessary, select initial pacer output. To select pacer rate or pacer output, rotate the Navigation

knob to select an appropriate value and press it to confirm the selection. Do not forget to press the Navigation

knob to exit the setting after desired value is selected.

5. Press the [Start Pacing] soft key to start pacing. The message “Pacing” appears in the pacer information area. .

NOTE

z

Pacing will not start if there is a problem with the pads cable connection, pad patient connection, or ECG

monitoring electrodes connection. If either situation occurs, a message will appear in the pacer information

area to alert you that a lead is disconnected or that the pads have a poor connection.

6. Verify that white pacing 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 pacing marker), and then decrease the output to the lowest level that still maintains

capture.

Pacing markers

9-5

8. Verify the presence of a peripheral pulse.

You can temporarily withhold pacing 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.

CAUTION

z

Routinely assess the patient’s cardiac output.

9.5.2 Fixed Mode Pacing

To pace in fixed mode:

1. Turn the Mode Select knob to the Pacer position.

2. Switch the pacer to the Fixed mode. To do so, move the cursor to the Pacer Mode hot key and rotate the Navigation

knob to select [Fix Mode]; then press it to confirm the selection, see the figure below:

3. If ECG electrodes are applied, use the Lead Select button to select the desired lead for viewing.

4. Select pacer rate. If necessary, select pacer output. To select pacer rate or pacer output, rotate the Navigation knob

to select an appropriate value and press it to confirm the selection.

5. Start pacing.

Press the [Start Pacing] soft key to start pacing. The message “Pacing” appears in the pacer information area. .

6. Verify that white pacing 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 pacing 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 pacing 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.

Pacer Mode

hot key

9-6

WARNING

z

Use care when handling the multifunction electrode pads on the patient to avoid shock hazard during

pacing.

z

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.

CAUTION

z

The monitoring or pacing function may be unstable in the presence of ESU or other electronic devices.

10-1

10

Monitoring Resp

10.1 Overview

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.

10.2 Safety

WARNING

z

When monitoring the patient’s respiration, do not use ESU-proof ECG cables.

z

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 View

RR alarm

high limit

RR alarm

low limit

RR reading

RR unit

10-2

10.4 Placing Resp Electrodes

As the skin is a poor conductor of electricity, preparing the skin is necessary for a good Respiration signal. You can refer

to the ECG section for how to prepare the skin.

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.

NOTE

z

To optimize the respiration waveform, place the RA and LA electrodes horizontally when monitoring

respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with

ECG Lead II.

Lead I Lead II

10-3

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.

NOTE

z

Respiration monitoring is not for use on the patients who are very active, as this will cause false alarms.

10.4.2 Changing Resp Wave Settings

In the [Resp Setup] menu, you can:

 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.

In the [Resp Setup] menu, you can also change the [Apnea Alarm Delay] as desired.

10-4

FOR YOUR NOTES

11-1

11

Monitoring PR

11.1 Overview

The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart. You can display a

pulse from SpO

2

. The displayed pulse numeric is color-coded to match SpO2 parameter.

11.2 Adjusting Pulse Tone Volume

When PR alarm is switched on, the equipment gives out pulse tone. You can select the PR parameter area to enter the

[PR Setup] menu, and then adjust [QRS Volume] to change the volume of pulse tone .The default QRS volume is 2.

When a valid SpO

2

value exists, the system will adjust the pitch of pulse tone according to the SpO2 value.

PR value

PR unit

PR alarm high limit

PR alarm low limit

11-2

FOR YOUR NOTES

12-1

12

Monitoring SpO2

12.1 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 SpO

2

module processes the

electrical signal and displays a waveform and digital values for SpO

2

and pulse rate.

This device is calibrated to display functional oxygen saturation. It provides the following measurements.

1. Pleth wave: visual indication of patient’s pulse. The waveform is not normalized.

2. SpO

2

unit

3. SpO

2

alarm high limit

4. SpO

2

alarm low limit

5. Oxygen saturation of arterial blood (SpO

2

): percentage of oxygenated hemoglobin in relation to the sum of

oxyhemoglobin and deoxyhemoglobin.

6. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.

6

3

1

5

4

2

12-2

12.2 Safety

WARNING

z

Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to

all warnings and cautions.

z

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.

z

Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could potentially cause

burns.

z

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.

12.3 Identifying SpO

2

Modules

The equipment can be configured with any of the following SpO2 modules.

 Mindray SpO

2

module;

 Masimo SpO

2

module;

 Nellcor SpO

2

module.

For Masimo or Nellcor SpO

2

modules, you will see corresponding logo on the equipment.

12.4 SpO

2

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 adapter cable according to the connector type and connect it with the equipment.

5. Connect the sensor cable to the adapter cable.

6. Switch the Mode Select knob to Monitor.

NOTE

z

The SpO2 simulator can be used to check if the SpO2 sensor works properly. However, it cannot be used to

verify the accuracy of the SpO

2

sensor.

12-3

12.5 Changing SpO

2

Settings

You can access the [SpO2 Setup] menu by selecting the SpO2 parameter area

12.5.1 Setting SpO

2

Sensitivity

For Mindray SpO2 module, you can set [Sensitivity] to [High], [Med] or [Low] from the [SpO2 Setup] menu. For Masimo

SpO

2

module, you can set [Sensitivity] to [Normal] or [High], in which [Normal] is equivalent to [Med].

 When the [Sensitivity] is set to [High], the equipment is more sensitive to the changes to SpO

2

values, but the

measurement accuracy is relatively low. When monitoring critically ill patients whose pulsations are very weak, it is

strongly recommended that the sensitivity is set to [High].

 When the [Sensitivity] is set to [Low], the equipment responds slowly to the changes of SpO

2

value, but the

measurement accuracy is relatively high.

12.5.2 Monitoring SpO

2

and NIBP on the Same Limb

When monitoring SpO2 and NIBP on the same limb simultaneously, you can switch [NIBP Simul] on from the [SpO2

Setup] menu to lock the SpO

2

alarm status until the NIBP measurement ends. If you switch [NIBP Simul] off, low

perfusion caused by NIBP measurement may lead to inaccurate SpO

2

readings and therefore cause false physiological

alarms.

12.5.3 Changing Averaging Time

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 patient monitor 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.

To set the averaging time:

 For Mindray SpO

2

module, set [Sensitivity] to [High], [Med] or [Low] from the [SpO2 Setup] menu, which

respectively correspond to 7 s, 9 s and 11 s.

 For Masimo SpO

2

module, set [Averaging] to [2-4 s], [4-6 s], [8 s], [10 s], [12 s], [14 s] or [16 s] in the [SpO2 Setup]

menu.

12-4

12.5.4 Sat-Seconds Alarm Management

With traditional alarm management, high and low alarm limits are set for monitoring oxygen saturation. During

monitoring, as soon as an alarm limit is violated, an audible alarm immediately sounds. When the patient’s SpO

2

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

2

module to decrease the likelihood of false alarms caused by

motion artifacts. The Sat-Seconds limit controls the amount of time that SpO

2

saturation may be outside the set limits

before an alarm sounds. The method of calculation is as follows: the number of percentage points that the SpO

2

saturation falls outside the alarm limit is multiplied by the number of seconds that it remains outside the limit. This can

be stated as the equation: Sat-Seconds= Points × Seconds

Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. The figure below demonstrates the

alarm response time with a Sat-Seconds limit set at 50 and a low SpO

2

limit set at 90%. In this example, the patient’s

SpO

2

drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to

84% (6 points) for 6 seconds. The resulting Sat-Seconds are:

Points Seconds Sat-Seconds

2× 2 = 4

4× 3 = 12

6× 6 = 36

Total Sat-Seconds = 52

After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50 Sat-Seconds would have

been exceeded.

Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Normally, the patient’s SpO2

may fluctuate above and below an alarm limit, re-entering the non-alarm range several times. During such fluctuation,

the system sums the number of SpO

2

points, both positive and negative, until either the Sat-Seconds limit is reached, or

the patient’s SpO

2

re-enters the non-alarm range and remains there.

SpO

2

%

Second

12-5

12.5.5 Changing the Speed of the Pleth Wave

In the [SpO2 Setup] menu, select [Sweep] and then select the appropriate setting. The faster the wave sweeps, the

wider the wave is.

12.6 SpO

2

Desat Alarm

The defibrillator/monitor provides an SpO2 Desat alarm. The SpO2 Desat alarm provides an additional limit setting below

the SpO

2

low limit setting to notify you of potentially life threatening decreases in oxygen saturation.

The SpO

2

Desat alarm is a high-level exclusive alarm. You cannot change its alarm level.

You can Press the Main Menu button on the front panel, and then select [Alarm Setup >>]→ [Para. Alarm >>]→[Desat],

or select a parameter window and then select [Para. Alarm >>]→ [Desat] to set the Desat alarm.

NOTE

z

In the case that the SpO2 low limit alarm value is set below the Desat limit, the the SpO2 low limit is

automatically adjusted to the Desat value.

12.7 Pitch Tone

The pitch tone function enables the equipment to give variable pitches of heartbeat tone or pulse tone as the patient’s

SpO

2

level changes. This equipment provides 22 levels of pitch tone. The pitch of heartbeat tone or pulse tone rises as

SpO

2

level increases and falls as SpO2 level decreases.

There are two pitch tone modes. The select pitch tone mode, select [SpO2 Setup]→[Pitch Tone] from the Configuration

Main menu and toggle between [Mode 1] and [Mode 2].

If the SpO

2

is disabled, the pitch tone function will be disabled also.

12.8 Measurement Limitations

If you doubt the SpO2 readings, check the patient’s vital signs first. Then check the equipment and SpO2 sensor. The

following factors may influence the accuracy of measurement:

 Ambient light
 Patient movement (active and imposed motion)
 Diagnostic testing
 Low perfusion
 Electromagnetic interference, such as MRI environment
 Electrosurgical units
 Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin (MetHb)
 Presence of certain dyes, such as methylene and indigo carmine

12-6

 Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2
 Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor.

12.9 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.

12.10 Nellcor Information

 Nellcor Patents

This device may be covered by one or more of the following US patents and foreign equivalents: 5,485,847, 5,676,141,

5,743,263, 6,035,223, 6,226,539, 6,411,833, 6,463,310, 6,591,123, 6,708,049, 7,016,715, 7,039,538, 7,120,479, 7,120,480,

7,142,142, 7,162,288, 7,190,985, 7,194,293, 7,209,774, 7,212,847, 7,400,919.

 No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with

unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or

more of the patents relating to this device.

13-1

13

NIBP

13.1 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 IEC 60601-2-30/EN60601-2-30, NIBP monitoring is allowed while an electrosurgical operation is in

progress or a defibrillation shock is being delivered.

NIBP diagnostic significance must be decided by the doctor who performs the measurement.

NOTE

z

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 Safety

WARNING

z

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.

z

Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has occurred

or is expected.

z

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.

13-2

z

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.

z

If you doubt the NIBP readings, determines the patient’s vital signs by alternative means and then verify

that the equipment is working correctly.

13.3 Measurement Limitations

Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm, or if the patient is

on a heart-lung machine.

The measurement may be inaccurate or impossible,

 If a regular arterial pressure pulse is hard to detect;
 With excessive and continuous patient movement such as shivering or convulsions;
 With cardiac arrhythmias;
 Rapid blood pressure changes;
 Severe shock or hypothermia that reduces blood flow to the peripheries;
 Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery.

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 Measuring Procedure

13.5.1 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 or 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. Avoid compression or restriction of pressure tubes. Air must pass unrestricted

through the tubing.

6. Switch the Mode Select knob to Monitor.

13-3

Warning

z

Continuous CUFF pressure due to connection tubing kinking may cause blood flow interference and

resulting harmful injury to the patient.

13.5.2 Starting and Stopping NIBP Measurements

You can start and stop NIBP measurements by using the hardkey on the equipment’s front panel.

13.5.3 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.

13.5.4 Enabling NIBP Auto Cycling

1. Select the NIBP parameter area to access the [NIBP Setup] menu.

2. Select [Interval] and then select a desired time interval. Selecting [Manual] switches to manual mode.

3. Start the measurement manually. The equipment will then automatically repeat NIBP measurements at the set time

interval.

Warning

z

Continuous non-invasive blood pressure measurements may cause purpura, ischemia and neuropathy in

the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the 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.

13.5.5 Starting a STAT Measurement

1. Select the NIBP parameter area to access the [NIBP Setup] menu.

2. Select [NIBP STAT]. The STAT mode initiates a 5-minute continuous, automatic NIBP measurement.

13-4

13.6 Understanding the NIBP Numerics

The NIBP display shows numerics only as below. Your display may be configured to look slightly different.

1. Measurement mode

2. Pressure unit: mmHg or kPa

3. NIBP alarm high limit

4. NIBP alarm low limit

5. Time of last measurement

6. Systolic pressure

7. Diastolic pressure

8. Mean pressure at the completion of measurement, or cuff pressure during the measurement

13.7 Setting Initial Cuff Inflation Pressure

You can set the initial cuff inflation pressure manually. In the [NIBP Setup] menu, select [Initial Pressure] and then

select the appropriate setting. The cuff is inflated accordingly at the next NIBP measurement.

The table below list the setting range of initial cuff inflation pressure:

Patient category Range (mmHg) Default (mmHg) Accuracy (mmHg)

Adult 80 to 280 160

Pediatric 80 to 210 140

Neonate 60 to 140 90

10

NOTE

z

Setting initial cuff inflation pressure is disabled during NIBP measurement.

z

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

To set pressure unit, access configuration management. In the Configuration-Main menu, select [NIBP Setup]→[Press.

Unit] and toggle between [mmHg] and [kPa].

You can change NIBP unit only through configuration management.

21

3

4

5

7

6

8