M&B AED7000 Plus User manual

GLCX-06-AED7000 Plus-05
AED7000 Plus Automatic External
Defibrillator
Users Manual
V1.0
Editor:
Approval:
Date:
M&B Part NumberAED7000 Plus-101 – Revision 1.0

GLCX-06-AED7000 Plus-05
AED7000 Plus Automatic External
Defibrillator
Users Manual
V1.0
M&B Part NumberAED7000 Plus-101 – Revision 1.0

Table of Contents
1Preface .......................................................................................................1
1.1 MANUFACTURER............................................................................................................................1
1.2 MANUFACTURER'S RESPONSIBILITY...............................................................................................1
1.3 USER'S RESPONSIBILITY.................................................................................................................2
1.4 CONTACT AND TECHNICAL SUPPORT..............................................................................................2
1.5 DECLARATION OF CONFORMITY.....................................................................................................2
1.6 SYMBOLS .......................................................................................................................................4
2Safety ..........................................................................................................8
2.1 CONVENTIONS USED IN THE MANUAL ...........................................................................................8
2.2 GENERAL CAUTIONS AND NOTICES..............................................................................................10
2.3 PATIENT SAFETY ..........................................................................................................................11
2.4 DEFIBRILLATOR AND ELECTRODE PADS .......................................................................................15
2.5 BATTERY......................................................................................................................................17
2.6 CARE AND STORAGE ....................................................................................................................17
3Introducing the AED7000 Plus ....................................................... 19
3.1 OVERVIEW OF THE AED7000 PLUS AUTOMATIC EXTERNAL DEFIBRILLATOR ..............................19
3.2 GETTING THE AED7000 PLUS AUTOMATIC EXTERNAL DEFIBRILLATOR READY..........................22
3.3 GETTING TO KNOW THE AED7000 PLUS AUTOMATIC EXTERNAL
DEFIBRILLATOR...................................................................................................................................23
3.4 USER INTERFACE..........................................................................................................................24
3.5 AED7000 PLUS AUTOMATIC EXTERNAL DEFIBRILLATOR ACCESSORIES PART
LIST ....................................................................................................................................................27
4Self-test Function Introduction ...................................................... 28
4.1 SELF TEST LCD INDICATOR SIGNAL INTRODUCE ..........................................................................28
4.2 INTRODUCTION OF AED SELF-TEST FUNCTION.............................................................................28
4.3 SELF-TEST FUNCTION DESCRIPTION IN DETAIL..............................................................................28
4.4 ACTIONS REQUIRED DURING AED SELF-TESTING ........................................................................29

5Using the AED7000 Plus Automatic External
Defibrillator................................................................................................. 30
5.1 OVERVIEW ...................................................................................................................................30
5.2 ASSESS THE PATIENT ....................................................................................................................30
5.3 START THE AED7000 PLUS AUTOMATIC EXTERNAL DEFIBRILLATOR ..........................................31
5.4 ATTACH THE ELECTRODE PADS TO THE PATIENT............................................................................32
5.5 HEART RHYTHM ANALYZING........................................................................................................33
5.6 CHARGING PROCEDURE................................................................................................................34
5.7 DISCHARGING PROCEDURE ..........................................................................................................35
5.8 CARDIOPULMONARY RESUSCITATION PROCEDURE (CPR) ............................................................37
5.9 AN EMERGENCY CANCELLATION ..................................................................................................38
6Maintaining the Automatic External Defibrillator................... 40
6.1 MAINTENANCE.............................................................................................................................40
6.2 CLEANING AND DISINFECTING......................................................................................................42
6.3TROUBLESHOOTING .....................................................................................................................44
7Software operation ............................................................................. 48
7.1 AED7000PLUS START MENU........................................................................................................48
8Configure AED7000Plus.................................................................... 53
8.1 SYSTEM FUNCTION CONFIGURATION ............................................................................................53
8.2 ECG CONFIGURATION ..................................................................................................................56
8.3 BATTERY......................................................................................................................................60
9Guiding audio for the operators..................................................... 61
10 Specification ...................................................................................... 67
10.1DEVICE ........................................................................................................................................68
10.2ENVIRONMENT.............................................................................................................................68
10.3DEFIBRILLATOR............................................................................................................................69
PEDIATRIC ENERGY：.......................................................................................................................73

10.4BATTERY......................................................................................................................................74
10.5ELECTRODES................................................................................................................................74
10.6GUIDANCE AND MANUFACTURER'S DECLARATION........................................................................75
10.7RHYTHM RECOGNITION PERFORMANCE.......................................................................................80
11 Glossary............................................................................................... 82

1
1Preface
Do not attempt to use this equipment without thoroughly reading
and understanding these instructions.
1.1 Manufacturer
Manufacturer
Address Room 6319, Building 1, No.27
Yongwang Road
Daxing Bioengineering and Medicine Industry Base
Zhongguancun Science Park
Daxing District
102629 Beijing
PEOPLE'S REPUBLIC OF CHINA
Product Name
Automatic External Defibrillator
Device Type
AED7000 Plus
1.2 Manufacturer's Responsibility
M&B （Beijing M&B Electronic Instruments, Co., Ltd）is responsible for
the safety, reliability, and performance of the AED7000 Plus Automatic
External Defibrillator, only if the following conditions are met:
Assembly operations, extensions, readjustments, modifications, or
repairs are carried out by persons authorized by M&B.
The AED7000 Plus Automatic External Defibrillator equipment is
used in accordance with the instructions for use.

2
1.3 User's Responsibility
The AED7000 Plus Automated External Defibrillator is intended for use by
personnel who are authorized by a physician/medical director, and who
have had training in the use of an AED.
The user should be completely knowledgeable of the information contained
in the AED7000 Plus Automatic External Defibrillator Users Manual. As
with all other electronic patient care monitor, good clinical judgment
should be used when operating the AED7000 Plus Automatic External
Defibrillator. To ensure patient safety and proper operation, use only
manufacturer authorized parts and accessories.
User must save all shipping containers and packaging materials. When
shipping the AED7000 Plus and accessories for calibration, service, or
upgrades, the original shipping containers and packaging materials must be
used.
1.4 Contact and Technical Support
Please contact M&B if you have any questions regarding this notice
Telephone
[phone]
Fax
[phone]
Internet
www.mbelec.com
E-mail
[e-mail]
1.5 Declaration of Conformity
Manufacturer
Beijing M&B Electronic Instruments, Co., Ltd
Room 6319, Building 1, No.27
Yongwang Road
Daxing Bioengineering and Medicine Industry
Base
Zhongguancun Science Park

3
Daxing District
102629 Beijing
PEOPLE'S REPUBLIC OF CHINA
1.5.1 Declares that the CE-marketed product
Product Name:
Automatic External Defibrillator
Device Type:
BF
Model
Number:
AED7000 Plus
Accessories:
See list in manual
Complies with Council Directive 93/42/EEC (Medical Device Directive)
of June 14 1993 class IIbAnnex II
1.5.2 Standards
Num.
serial numbers of the
standards
The names of the standards
1
EN ISO13485:2012
Medical devices — Quality management
systems — Requirements for regulatory
purposes
2
EN ISO14971:2012
Medical devices - Application of risk management to
medical devices
3
EN 980:2008
Symbols for use in the labelling of medical devices
4
EN1041:2008
Medical devices - Information supplied by manufacturer
5
EN
60601-1:2006/A1:2013
Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance
6 EN
60601-1-2:2007/AC:2010
Medical electrical equipment - Part 1-
2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic
compatibility-requirements and tests
7
EN 60601-1-6:2010
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance-
Collateral Standard: Usability

4
8
EN 60601-2-4:2010
Medical electrical equipment -- Part 2-4: Particular
requirements for the safety of cardiac defibrillators
9
EN ISO 10993-1
：
2009/AC2010
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
10 EN62304：2006/A1：2008 Medical device software - Software life-cycle processes
11 EN
60601-1-8:2007/AC:2010 Medical electrical equipment -- Part 1-
8: General
requirements for basic safety and essential performance -
Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical
equipment and medical electrical systems
12
IEC 60601-1-12:2014
Medical electrical equipment - Part 1-12: General
requirements for basic safety and essential performance -
Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use
in the emergency medical services environment
1.6 Symbols
Symbols used in this manual or on the equipment include the following:
Machine symbols
Defibrillator
discharge button
Power on/off button
Nameplate symbols

5
Manufacturer mark:
Beijing M&B Electronic Instruments Co., Ltd.
Serial number
General warning sign
BF and Defibrillation-proof applied parts
Date of manufacture
MANUFACTURER
Do not throw it away
European R
epresentative: Shanghai
International Holding Corp.
GmbH(Europe) Eiffestrasses 80, 20537
Hanburg, Germany
Follow instructions for use
Outer signs of packing box
TEMPERATURE LIMITATION
KEEP DRY
Keep up