Mindray BeneHeart D1 User manual

BeneHeart D1
Automated External Defibrillator
Operator’s Manual

I
© 2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
For this Operator’s Manual, the issue date is 2014-01.

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
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.

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 or unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, High-tech industrial park,
Nanshan, Shenzhen 518057, P.R.China
Website: www.mindray.com
E-mail Address: [email protected]om.cn
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 ...................................................................................................................................................................................................1-1
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 ECG............................................................................................................................................................................................................2-2
2.3 Main Unit................................................................................................................................................................................................................2-2
2.3.1 Front View...............................................................................................................................................................................................2-2
2.3.2 Side View.................................................................................................................................................................................................2-3
2.3.3 Rear View.................................................................................................................................................................................................2-4
2.4 Display Views.........................................................................................................................................................................................................2-5
2.5 Soft Key Symbols.................................................................................................................................................................................................2-6
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
3.1.3 Installing the Battery ..........................................................................................................................................................................3-2
3.1.4 Connecting Electrode Pads..............................................................................................................................................................3-2
3.2 Basic Operations..................................................................................................................................................................................................3-3
3.2.1 Turning Power On................................................................................................................................................................................3-3
3.2.2 Changing General Settings ..............................................................................................................................................................3-3
3.2.3 Turning off the Equipment...............................................................................................................................................................3-4
3.2.4 Auto Restoring to Last Configuration...........................................................................................................................................3-4
3.3 Post Use Procedure.............................................................................................................................................................................................3-4
4 Alarms........................................................................................................................................................................... 4-1
4.1 Alarm Categories.................................................................................................................................................................................................4-1
4.2 Alarm Levels..........................................................................................................................................................................................................4-1
4.3 Alarm Indicators...................................................................................................................................................................................................4-2
4.3.1 Audible Alarms .....................................................................................................................................................................................4-2
4.3.2 Alarm Message .....................................................................................................................................................................................4-2
4.3.3 Alarm Status Symbols ........................................................................................................................................................................4-2
4.4 Alarm Tone Configuration................................................................................................................................................................................4-3

2
4.4.1 Changing the Alarm Volume...........................................................................................................................................................4-3
4.4.2 Pausing Alarm Sounds....................................................................................................................................................................... 4-3
4.4.3 Switching Off Alarm Sounds ...........................................................................................................................................................4-3
4.5 Reminder Tones ...................................................................................................................................................................................................4-4
4.6 Clearing Technical Alarms................................................................................................................................................................................ 4-4
4.7 When an Alarm Occurs......................................................................................................................................................................................4-4
5 AED ............................................................................................................................................................................... 5-1
5.1 Overview................................................................................................................................................................................................................5-1
5.2 Safety.......................................................................................................................................................................................................................5-1
5.3 AED View ................................................................................................................................................................................................................5-2
5.4 AED Procedure .....................................................................................................................................................................................................5-3
5.5 Shock Advised......................................................................................................................................................................................................5-4
5.6 No Shock Advised (NSA)...................................................................................................................................................................................5-5
5.7 CPR ...........................................................................................................................................................................................................................5-5
5.7.1 CPR Metronome...................................................................................................................................................................................5-5
5.8 AED Sound Recording.......................................................................................................................................................................................5-6
5.9 AED Setup..............................................................................................................................................................................................................5-6
6 Manual Defibrillation (For Pro Only).......................................................................................................................... 6-1
6.1 Overview................................................................................................................................................................................................................6-1
6.2 Safety.......................................................................................................................................................................................................................6-1
6.3 Manual Defibrillation View ..............................................................................................................................................................................6-2
6.4 Manual Defibrillation Procedure ...................................................................................................................................................................6-3
6.5 Synchronized Cardioversion ...........................................................................................................................................................................6-4
6.5.1 Performing Synchronized Cardioversion.................................................................................................................................... 6-4
6.5.2 Delivering Additional Synchronized Shocks .............................................................................................................................6-5
6.5.3 Disabling the Sync Function............................................................................................................................................................6-5
7 Monitoring ECG (For Pro Only) ................................................................................................................................... 7-1
7.1 Overview................................................................................................................................................................................................................7-1
7.2 Safety.......................................................................................................................................................................................................................7-1
7.3 ECG View.................................................................................................................................................................................................................7-2
7.4 Preparing to Monitor ECG................................................................................................................................................................................7-2
7.4.1 ECG Monitoring with Electrodes.................................................................................................................................................... 7-2
7.4.2 ECG Monitoring with Pads ...............................................................................................................................................................7-3
7.5 Changing ECG Settings.....................................................................................................................................................................................7-4
7.5.1 Selecting Lead Type............................................................................................................................................................................ 7-4
7.5.2 Setting Gain........................................................................................................................................................................................... 7-4
7.5.3 Choosing AHA or IEC Lead Placement.........................................................................................................................................7-4
7.5.4 Setting Filter Mode .............................................................................................................................................................................7-4
7.6 Arrhythmia Analysis ........................................................................................................................................................................................... 7-5
7.6.1 Understanding the Arrhythmia Events........................................................................................................................................7-5
7.6.2 Setting Arrhythmia Analysis............................................................................................................................................................ 7-6
7.6.3 Changing Arrhythmia Threshold Settings..................................................................................................................................7-6
7.6.4 Automatic Arrhythmia Relearn.......................................................................................................................................................7-7

3
8 Data Management....................................................................................................................................................... 8-1
8.1 Introduction ..........................................................................................................................................................................................................8-1
8.2 Recommended USB Flash Memory ..............................................................................................................................................................8-1
8.3 Exporting Data .....................................................................................................................................................................................................8-2
9 Configuration Management ....................................................................................................................................... 9-1
9.1 Introduction ..........................................................................................................................................................................................................9-1
9.2 Viewing System Configuration.......................................................................................................................................................................9-1
9.3 Password.................................................................................................................................................................................................................9-1
9.4 Accessing Configuration Management.......................................................................................................................................................9-1
9.5 Restoring Factory Default Configuration....................................................................................................................................................9-2
9.6 List of Configuration Items...............................................................................................................................................................................9-2
9.6.1 General Setup Menu...........................................................................................................................................................................9-2
9.6.2 AED Setup Menu..................................................................................................................................................................................9-3
9.6.3 Manual Defib Setup Menu (For Pro Only)...................................................................................................................................9-3
9.6.4 CPR Setup Menu...................................................................................................................................................................................9-4
9.6.5 ECG Setup Menu (For Pro Only)......................................................................................................................................................9-4
9.6.6 Alarm Setup Menu (For Pro Only)..................................................................................................................................................9-4
9.6.7 Test Setup Menu...................................................................................................................................................................................9-4
9.6.8 Network Setup Menu .........................................................................................................................................................................9-5
9.6.9 Config. Menu.........................................................................................................................................................................................9-5
10 Battery...................................................................................................................................................................... 10-1
10.1 Introduction..................................................................................................................................................................................................... 10-1
10.2 Battery Alarms................................................................................................................................................................................................. 10-2
10.2.1 Low Battery Alarm.......................................................................................................................................................................... 10-2
10.2.2 Battery Aged Alarm ....................................................................................................................................................................... 10-2
10.2.3 Battery Error Alarm ........................................................................................................................................................................ 10-2
10.3 Replacing Batteries........................................................................................................................................................................................ 10-3
10.4 Charging Batteries......................................................................................................................................................................................... 10-3
10.5 Storing Batteries............................................................................................................................................................................................. 10-4
10.6 Recycling the Batteries................................................................................................................................................................................. 10-4
11 Care and Cleaning ................................................................................................................................................... 11-1
11.1 General Points................................................................................................................................................................................................. 11-1
11.2 Cleaning ............................................................................................................................................................................................................ 11-2
11.3 Disinfecting...................................................................................................................................................................................................... 11-2
12 Maintenance and Testing........................................................................................................................................ 12-1
12.1 Overview........................................................................................................................................................................................................... 12-2
12.2 Maintenance and Testing Schedule........................................................................................................................................................ 12-2
12.3 Carrying Out Maintenance and Testing................................................................................................................................................. 12-2
12.3.1 Power-On Test.................................................................................................................................................................................. 12-3
12.3.2 Real-Time Test .................................................................................................................................................................................. 12-3
12.3.3 Battery Insert Test........................................................................................................................................................................... 12-3
12.3.4 Auto Test............................................................................................................................................................................................ 12-3

4
12.3.5 User Test .............................................................................................................................................................................................12-4
12.3.6 Electrical Safety Tests.....................................................................................................................................................................12-4
13 Troubleshooting ...................................................................................................................................................... 13-1
13.1 General Problems...........................................................................................................................................................................................13-1
13.2 Alarm Messages ..............................................................................................................................................................................................13-2
13.2.1 Physiological Alarm Messages (For Pro Only).......................................................................................................................13-2
13.2.2 Technical Alarm Messages...........................................................................................................................................................13-3
14 Accessories............................................................................................................................................................... 14-1
14.1 ECG Accessories ..............................................................................................................................................................................................14-1
14.2 Therapy Accessories.......................................................................................................................................................................................14-2
14.3 Miscellaneous ..................................................................................................................................................................................................14-2
A Specifications ..............................................................................................................................................................A-1
A.1 General Specifications ......................................................................................................................................................................................A-1
A.2 Defibrillator Specifications..............................................................................................................................................................................A-2
A.3 Monitor Specifications......................................................................................................................................................................................A-4
A.4 Power Supply Specifications ..........................................................................................................................................................................A-6
A.5 Alarm Specifications..........................................................................................................................................................................................A-7
A.6 Data Management Specifications ................................................................................................................................................................A-7
A.7 Wireless Network ................................................................................................................................................................................................A-7
A.8 Environmental Specifications ........................................................................................................................................................................A-7
B EMC............................................................................................................................................................................... B-1
C BeneHeart D1 User Checklist...................................................................................................................................... C-1
D Prompt Messages........................................................................................................................................................D-1
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 Patient Leakage Current................................................................................................................................................................................... E-2
E.5 Mains on Applied Part Leakage ..................................................................................................................................................................... E-2
E.6 Patient Auxiliary Current .................................................................................................................................................................................. E-3
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

1-1
1Safety
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.
1.1.1 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.
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.
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.

1-2
1.1.2 Warnings
WARNING
Check for mechanical damages before each use. If case of any damage, do not apply it to patients.
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.
Run the equipment only on the supplied disposable or rechargeable battery.
Charge the rechargeable battery only with the supplied BatteryFeed 20 charger station.
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.
For the treatment of patients with implantable pacemakers, place therapy pads 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, 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.
Keep a distance of at least 20cm away from the monitor when Wi-Fi function is in use.

1-3
1.1.3 Cautions
CAUTION
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.
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.
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.
This manual describes all features and options. Your equipment may not have all of them.
To ensure that the equipment is ready for any urgent use, keep it with battery installed and pads
preconnected.
If the equipment has been dropped or mishandled, perform a user test. If any item fails, contact the
authorized service personnel.

1-4
1.2 Equipment Symbols
Caution (Attention, consult
accompanying documents)
Stand-by
Shock button USB connector
Serial number Date of manufacture
Unlocking
Open the battery door as indicated
Operating instructions
General symbol for
recovery/recyclable
Do not expose the battery to high
heat or open flames. Do not
incinerate the battery.
Do not crush the battery.
Do not mutilate the battery or open the battery case.
Mark of conformity to European Medical Device Directive 93/42/EEC
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
Dispose of in accordance to your country’s requirements

2-1
2The Basics
It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims receive
treatment. For every minute of delay, the chance of survival declines by 7% to 10%. Treatment cannot assure survival. In
some patients, the underlying problem causing the cardiac arrest is simply not survivable despite any available care.
2.1 Overview
The BeneHeart D1 (hereinafter called the equipment) is a lightweight and portable automated external defibrillator.
There are two types of configuration for the equipment: Pro and Public. Public provides only AED mode while Pro
provides two operating modes: AED and Manual Defib mode.
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 is performed through multifunction electrode pads. In Manual Defib mode, you can also perform
synchronized cardioversion.
In Manual Defib mode, the equipment also provides monitoring, displaying and storing of 3-lead ECG.
The equipment can be powered by a supplied disposable battery or a smart lithium ion battery which is rechargeable
and maintenance-free. You can easily determine the remaining battery charge by viewing the battery power gauge
displayed on the screen. For rechargeable batteries, you can also check the indicator on the battery itself.
The equipment automatically stores patient data in an internal storage card. You can also export the data through the
USB port for viewing on a PC through the data management software.
2.2 Intended Use
Pro is intended for automatic defibrillation (AED) and manual defibrillation treatments. It guides operators through
Cardiopulmonary resuscitation (CPR) and can also be used for ECG monitoring.
Public is intended for AED. It also guides operators throughout CPR.
The equipment is for use in 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 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 ECG
The ECG monitoring function is used to monitor and/or store the patient’s ECG waveform and heart rate.
2.3 Main Unit
2.3.1 Front View
1. Pads connector
It is used to connect the multifunction electrode pads.
1
2
3
4
5
6
7
9
8

2-3
2. Status indicator
Green: All the tests are passed, and the equipment operates properly.
Red: Failure is detected on the equipment.
3. Display screen
4. Soft keys
They are corresponding with the soft key labels located immediately above. The labels of the soft keys change
according to the current operating mode. For Pro, there are five soft keys while for Public, there are three.
5. Shock button
Press this button to deliver a shock to the patient.
6. Handle
7. Power ON/OFF button
Press this button to turn on or off this equipment.
8. Optical sensor
9. Microphone
2.3.2 Side View
1. Speaker
2. USB connector
3. ECG: ECG cable connector (for Pro only)
1
2
3

2-4
2.3.3 Rear View
1. Pads compartment
2. Battery compartment
3. Release button
Press down this button and slide the battery door to the right to open the battery compartment.
1
2
3