Mindray BeneHeart D1 Operator's Manual

BeneHeart D1

Automated External Defibrillator

Operator’s Manual

© 2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

For this Operator’s Manual, the issue date is 2014-01.

I

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.

II

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.

III

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: [e-mail]

Tel: [phone]

Fax: [phone]

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

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: [phone]

Fax: [phone]

IV

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.

V

FOR YOUR NOTES

VI

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

1

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

2

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

3

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

4

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.

1.1.1 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.

1-1

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.

1-2

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.

1-3

1.2 Equipment Symbols

Caution (Attention, consult

accompanying documents)

Shock button

Serial number

Unlocking

Operating instructions

Do not expose the battery to high

heat or open flames. Do not

incinerate the battery.

Stand-by

USB connector

Date of manufacture

Open the battery door as indicated

General symbol for

recovery/recyclable

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

1-4

2 The 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.

2-1

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

2

3

6

7

4

5

1. Pads connector

It is used to connect the multifunction electrode pads.

2-2

8

9

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

2

1. Speaker

2. USB connector

3. ECG: ECG cable connector (for Pro only)

3

2-3

2.3.3 Rear View

1

2

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.

3

2-4

2.4 Display Views

For Pro

8

9

10

11

For Public

1

1

2

2

3

3

4

4

5 6

7

5 6

10

11

1. Alarm status symbols

 indicates alarm sounds are paused;

7

 indicates alarm sounds are turned off.

2. Alarm area

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

2-5

3. Number of delivered shocks

4. Runtime area

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

5. Patient type

6. Record icon

It is displayed if the sounding recording function is enabled.

7. Battery Status indicator

It indicates battery status. Refer to 10 Battery for details.

8. Heart rate

9. Waveform area

This area shows the ECG waveforms.

10. Therapy information area

11. Soft key label area

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

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

soft key is inactive.

2.5 Soft Key Symbols

Below is the description of symbols displayed in the soft key label area:

Return to the previous page

Move to the previous item/page

Display more options

Switch to Adult or Pediatric mode

Power off

Show more instructions Change the compression/ventilation rate

Audio Language softkey

Switch the language of audio prompts. The symbol changes if the system language is changed. The

larger symbol indicates the current language while the smaller one indicates the target language.

This symbol is for Public only. It is displayed only when [Bilingual Option] is set to [On]

Enter/Confirm

Move to the next item/page

Confirm selection

Start archive

Maintenance

2-6

3 Basic Operations and Settings

3.1 Installation

WARNING

 The equipment shall be installed by personnel authorized by the manufacturer.
 The software copyright of the equipment is solely owned by the manufacturer. No organization or

individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form

or by any means without due permission.

 Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC

60950 safety standards for information technology equipment and IEC 60601-1 safety standards for

medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1-1

medical electrical systems standard. Any personnel who connect devices to the equipment’s signal

input/output port is responsible for providing evidence that the safety certification of the devices has

been performed in accordance to the IEC 60601-1-1. If you have any question, please contact the

manufacturer.

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

example, due to summation of leakage currents, consult the manufacturers or else an expert in the field, to

ensure the necessary safety of all devices concerned will not be impaired by the proposed combination.

NOTE

 To ensure that the equipment is ready for any urgent use, keep it with battery installed and pads

preconnected.

3.1.1 Unpacking and Checking

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

or the manufacturer. If the packing case is intact, open the package and remove the equipment and accessories carefully.

Check all materials against the packing list and check for any mechanical damage. If you have any question, please

contact us.

WARNING

 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.

 The equipment might be contaminated during storage and transport. Before use, please verify whether

the packages are intact, especially the packages of single use accessories. In case of any damage, do not

apply it to patients.

3-1

NOTE

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

3.1.2 Environmental Requirements

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

The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive,

flammable and explosive substances. If the equipment is installed in a cabinet, sufficient space in front and behind shall

be left for convenient operation, maintenance and repair. Moreover, to maintain good ventilation, the equipment shall

be at least 2 inches (5 cm) away from around the cabinet.

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

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

NOTE

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

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

3.1.3 Installing the Battery

To install the battery:

1. Press down the release button and slide the battery door to the right as indicated to remove the battery door.

2. Align the battery pins with the battery connecter, slide the battery into the battery compartment, and press until

you hear it click into the place.

3. Cover the battery door on the compartment, and slide to the left until you hear it click into the place.

NOTE

 Check the expiration date displayed on the disposable battery. Remove from use if the battery is expired.
 Make sure the battery door is reinstalled properly to protect the equipment and battery.

3.1.4 Connecting Electrode Pads

1. Plug the pads connector into the pads socket.

2. Place the pads package into the pads compartment properly and carefully.

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NOTE

 Make sure the pads package is intact before use. Otherwise, replace it with a new one.

3.2 Basic Operations

3.2.1 Turning Power On

1. Check for mechanical damages on the equipment or other damages on the pads package.

2. Make sure the pads cable is properly connected and battery installed.

3. Check the expiration date of the pads on the pads package.

4. Press the Power ON/OFF button to start the equipment.

3.2.2 Changing General Settings

You can change the general settings in the [General Setup] menu.

To access the [General Setup] menu,

 If the equipment is on, press the Power ON/OFF button and the “Select an option” window is displayed.

Then .select

 If the equipment is off:

 For Pro, press the Power ON/OFF button, the third and fourth soft keys (from left to right) simultaneously to

display the maintenance screen;

 For Public, press the Power ON/OFF button, the second and third soft keys (from left to right)

simultaneously.

Then select [Config.]→[Config. Edit]→enter the required password→[General Setup].

→[Config.]→[Config. Edit]→enter the required password→[General Setup].

NOTE

 All changes made in Configuration mode are auto-saved immediately. You can turn off the equipment

after the setting is finished.

3.2.2.1 Setting the Date and Time

1. In the [General Setup] menu, select [System Date] to set the system date.

2. Select [Time] to set the system time.

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3.2.2.2 Selecting System Language

In the [General Setup] menu, select [Language] to set the system language, which refers to the language of messages,

menus, and audio prompts and so on.

If the system language is set to a non-English language, you can also set [Bilingual Option] in the [General Setup]

menu. When [Bilingual Option] is set to [On], the text prompts in AED mode are displayed in English and the set system

language. And for Public, you can press the Audio Language softkey to switch the language of audio prompts. For

details about the softkey, refer to 2.5 Soft Key Symbols.

For Pro, [Bilingual Option] is disabled when [ECG Display] is set to [On].

3.2.2.3 Setting Default Startup Mode (For Pro Only)

For Pro, in the [General Setup] menu, select [Default Startup Mode] and set the default startup mode to:

 [AED]: the equipment enters AED mode by default after startup; or,
 [Manual]: the equipment enters Manual Defib mode by default after startup.

3.2.3 Turning off the Equipment

To turn off the equipment, follow this procedure:

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

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

3. Press the Power ON/OFF button and the “Select an option” window is displayed.

4. Press the

soft key to shut down the equipment.

3.2.4 Auto Restoring to Last Configuration

During operation, you may make changes to some settings. However, these changes may not be saved as user

configuration. To prevent the changes from losing in case of sudden power failure, the equipment saves the settings in

real time. The saved settings are the latest configuration. In case of power failure, the equipment loads the latest

configuration if restarts within 60 seconds; it loads the user configuration if restarts 120 seconds later after the power

failure; it may load either the latest configuration or the user configuration if restarts between 60 and 120 seconds after

the power failure.

3.3 Post Use Procedure

After the equipment has been used on a patient, the unit shall be cleaned as described in 11 Care and Cleaning. Then

follow the procedure below to prepare the equipment for next use:

1. Connect a new pads package to the equipment as described in 3.1.4 Connecting Electrode Pads.

2. Perform a user test as described in 12.3.5 User Test. Check the test result and make sure all test items are passed.

3. Turn off the equipment.

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4 Alarms

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

user by visual and audible alarm indications.

WARNING

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

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

4.1 Alarm Categories

By nature, Pro’s alarms can be classified into two categories: physiological alarms and technical alarms while Public

provides only technical alarms.

1. Physiological alarms

Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates

set alarm limits or by an abnormal patient condition. In AED mode, no physiological alarm will be presented.

2. Technical alarms

Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion

due to improper operation or system failure.

Alarm messages are displayed in the alarm area.

Apart from the physiological and technical alarms, the equipment also shows some messages indicating system status.

Technically, prompt messages are not alarm messages. Messages of this kind are usually displayed in corresponding

information area. Some special prompts are shown in dialog boxes.

4.2 Alarm Levels

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

Physiological alarms (For Pro only) Technical alarms

High

level

Medium

level

Low

level

Indicate that your patient is in a life threatening

situation, such as Asystole, Vfib/Vtac and so forth,

and an emergency treatment is demanded.

Indicate that your patient’s vital signs appear

abnormal and an immediate treatment is required.

Indicate that you patient’s vital signs appear

abnormal and an immediate treatment may be

required.

Indicate a severe device malfunction or an improper

operation, which could make it possible that the equipment

cannot detect critical patient status or may cause therapy

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

/

Indicate a device malfunction or an improper operation,

which may compromise a certain function but will not

threaten the patient’s life.

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4.3 Alarm Indicators

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

 Alarm tones
 Alarm message

NOTE

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

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

circularly.

4.3.1 Audible Alarms

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

 High level alarms triple+double+triple+double beeps.
 Medium level alarms triple beeps.
 Low level alarms single beep.

4.3.2 Alarm Message

When an alarm occurs, the alarm message will appear in the technical or physiological alarm area. For physiological

alarms, the asterisk symbols (*) before the alarm message match the alarm level as follows:

 High level alarms ***
 Medium level alarms **
 Low level alarms *

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

 High level alarms shifts fast between black text on red background and red text on white background

(in a frequency of 2 Hz)

 Medium level alarms shifts slowly between black text on yellow background and yellow text on white

background (in a frequency of 0.5 Hz)

 Low level alarms black text on yellow background

4.3.3 Alarm Status Symbols

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



 indicates alarm sounds are turned off. You can only restore the alarm sound in configuration mode.

indicates the alarm sounds for current alarms are paused. If new alarms are triggered, alarm sounds restore

to normal.

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4.4 Alarm Tone Configuration

4.4.1 Changing the Alarm Volume

1. If the equipment is on, press the Power On/Off button and then select →[Config.→][Config. Edit→]enter

the required password→[Alarm].

2. Set [Alm Volume] to any of the following:

 [High]: the alarm volume is set to the highest level.
 [Med]: the alarm volume is set to a medium level.
 [Low]: the alarm volume is set to a lower level.
 [Off]: the alarm sound is disabled.

NOTE

 The alarm volume for special system alarms is always high and not user-adjustable.

4.4.2 Pausing Alarm Sounds

You can press the [Silence] softkey to temporarily disable alarm tones. In this case, the symbol will be displayed in

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

indicators except audible alarm tones works properly. You can press [Silence] again to restore alarm sounds.

If new alarms are triggered, alarm sounds restore to normal automatically.

NOTE

 The alarm volume for special system alarms cannot be paused.

4.4.3 Switching Off Alarm Sounds

1. If the equipment is on, press the Power On/Off button and then select →[Config.→][Config. Edit→]enter

the required password→[Alarm].

2. Set [Alm Volume] to [Off] to switch off the alarm sounds.

In the audio off status, appears in the sound symbol area. In this case, all alarm indicators except audible alarm

tones works properly. To resume the alarm sounds, set [Alm Volume] to [High], [Med] or [Low].

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

The volume for reminder tone is set to a fixed level and not user-adjustable.

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4.5 Reminder Tones

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

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

[Config. Edit] menu.

4.6 Clearing Technical Alarms

For some technical alarms, their alarm message background flashing and alarm tones are cleared and the alarm

messages change to prompt messages after [Silence] soft key is pressed. After the equipment restores the normal alarm

status, it can give alarm indications correctly in case these alarms are triggered again.

For some technical alarms, all their alarm indications are cleared after [Silence] soft key is pressed. After the equipment

restores the normal alarm status, it can give alarm indications correctly in case these alarms are triggered again.

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

[Silence] soft key is pressed. After the equipment restores the normal alarm status, all the alarm indications will continue

if the alarm conditions still present.

4.7 When an Alarm Occurs

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

1. Check the patient’s condition.

2. Confirm the alarming parameter or alarm category.

3. Identify the alarm source.

4. Take proper action to eliminate the alarm condition.

5. Make sure the alarm condition is corrected.

For actions taken with regard to specific alarms, see 13 Troubleshooting.

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