Mindray BeneHeart D3 Operator's Manual

BeneHeart D3

Defibrillator/Monitor

Operator’s Manual

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

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

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

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

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

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: service@mindray.com.cn

Tel: +86 755 81888998

Fax: +86 755 26582680

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

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

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.

FOR YOUR NOTES

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

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

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

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

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

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

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

FOR YOUR NOTES

1-1

Safety

1.1 Safety Information

DANGER

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

WARNING

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

CAUTION

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

product/property damage.

NOTE

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

1-2

1.1.1 Dangers

DANGER

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

Operating Instructions, this electrical energy may cause serious injury or death. Do not attempt to operate

this defibrillator unless thoroughly familiar with these operating instructions and the function of all

controls, indicators, connectors, and accessories.

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

patient or metal devices connected to the patient during defibrillation.

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

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

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

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

operating environment dry and clean.

1.1.2 Warnings

WARNING

Before putting the system into operation, the operator must verify that the equipment, connecting cables

and accessories are in correct working order and operating condition.

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

necessary.

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.

This equipment is used for single patient at a time.

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

during defibrillation.

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

Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to

a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized

according to different patient situations and always keeping the patient under close surveillance is the most

reliable way for safe patient monitoring.

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

might be shocked.

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

that was analyzed as shockable converting spontaneously to non-shockable and could result in

inappropriate delivery of a shock.

1-3

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.

To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and

secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel.

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

with the patient; otherwise patient injury may result.

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

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

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

Failure to enter correct password will prevent the delivery of manual defibrillation, synchronized

cardioversion and pacing therapy.

At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance

with the guidelines regulating the disposal of such products to avoid contaminating the environment.

Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For

this reason make sure that all external devices operated in the vicinity of the equipment comply with the

relevant EMC requirements. Mobile phones, X-ray equipment or MRI devices are a possible source of

interference as they may emit higher levels of electromagnetic radiation.

Before connecting the equipment to the power line, check that the voltage and frequency ratings of the

power line are the same as those indicated on the equipment’s label or in this manual.

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

other mechanical force.

Dry the equipment immediately in case of rain.

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

damage could occur.

1.1.4 Notes

NOTE

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

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

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

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

1-4

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

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

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

), 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

, 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

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

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.

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.

7 6

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.

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

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

: SpO2 sensor connector

4. NIBP: NIBP cuff connector

Therapy port

+ 156 hidden pages

Mindray BeneHeart D3 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual