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

6
Fragile
CONFORMITE EUROPEENNE
Pads symbols
CONFORMITE EUROPEENNE
DO NOT REUSE
KEEPAWAYFROM SUNLIGHT
LATEX
FREE
DO NOT CONTAINS OR PRESENCE
OF NATURAL RUBBER LATEX
HIGH VOLTAGE
TEMPERATURE LIMITATION
DO NOT USE IF PACKAGE IS
DAMAGED
USE BY
BATCH CODE

7
CONSULT INSTRUCTIONS FOR USE
Weighing less than 25 kg can not be used
Do not open the seal unless the Pad is to
be used at once
The continuous working time can not
exceed 24 hours

8
2Safety
2.1 Conventions Used in the Manual
This section includes a list of conventions used in this manual.
2.1.1 Warnings
Warnings alert the user to a special condition that could result in
serious personal injury or death. In this manual, warnings are
displayed as shown in the following example:
WARNING!
Includes conditions, hazards, or unsafe practices that
can result in serious personal death.
2.1.2 Cautions
Cautions alert the user to a special condition that could result in
minor personal injury or damage to the equipment. In this manual,
cautions are displayed as shown in the following example:
Caution
Conditions, hazards, or unsafe practices that can result
in minor personal injury, damage to the AED7000
Plus, or loss of data.

9
2.1.3 Notes
Notes contain information that augments or clarifies an operating
step. Notes do not normally contain actions. They follow the
procedural steps to which they refer. In this manual, notes are
displayed as shown in the following example:
Note
If the AED7000 Plus
is used more than once per
month, it is recommended that authorized service
personnel perform a periodic inspection servicing at
least once per year.
2.1.4 Voice prompts
The AED7000 Plus provides audio instructions through the
built-in speaker to provide operating instructions and assist the
user during defibrillation. In this manual, voice prompts are
displayed as shown in the following example:
Check the electrodes.
2.1.5 Safety information is organized in six groups:
General Cautions and Notices
Patient Safety
Defibrillator and Electrode Pads
Battery
Care and Storage
Safety Symbols

10
2.2 General Cautions and Notices
2.2.1 Dropped or Damaged
If the device has been dropped or damaged in any way, refer
the device to qualified service personnel for servicing.
2.2.2 Ferromagnetic Equipment
ECG electrodes and cables contain ferromagnetic materials.
They must not be used in the presence of large magnetic
fields created by magnetic resonance imaging (MRI)
equipment. The large magnetic fields generated by an MRI
device could move ferromagnetic equipment with an
extremely violent force that could cause serious personal
injury or death to persons between the equipment and the
MRI device.
2.2.3 Labels
Observe all CAUTION and WARNING labels on the
equipment and accessories.
2.2.4 Performance
The AED7000 Plus may not meet performance specifications
if stored, transported or used outside the specified storage or
operating environmental range limits.

11
2.2.5 Notices
If the battery pack is removed for any reason, the user must
label the AED7000 Plus as "Out of service due to battery
operation."
Do not use mobile phones near the AED7000 Plus as the
radiation field produced by mobile phones will interfere with
the functioning of theAED7000 Plus.
A warning that the AED7000 Plus should not be used
adjacent to or stacked with other equipment and that if
adjacent to or stacked use is necessary, the AED7000 Plus
should be observed to verify normal operation in the
configuration in which it will be used.
2.2.6 Attention
Electric and magnetic fields can interfere with the
equipment’s regular work. Therefore, please ensure all
external devices used near the AED7000 Plus comply with
EMC demands.
2.3 Patient Safety
2.3.1 General
Warning
Accessory
adapter required for use on
pediatric patients.
he AED 7000 is not to be used on patients less
than 8 years old or under 25kg
(55 lbs), unless it is equipped with the

12
accessoryAED 7000 Pediatric Energy
Reducer
.
Caution
Patient Physical Harm
Place the
AED7000 Plus in a position where it
cannot harm the patient should it fall. Do not
use adjacent to or stacked with other
equipment. Keep all cables and connectors
away from the patient's neck.
2.3.2 Shock Hazard
Warning
Defibrillation current can cause injury
Do not touch the patient during defibrillation.
Do not touch equipment connected to or metal
objects in contact with the patient during
defibrillation.
Disconnect other electrical equipment which
has no DEFIBRILLATION
-PROOF applied
parts
from the patient before defibrillating.
Avoid contact between parts of the patient’s
body such as exposed skin of head or limbs,
conductive fluids such as gel, blood or saline
and metal objects such as a bed frame or a
stretcher which may provide unwant
ed
pathways for the defibrillating current.

13
2.3.3 Burn
Warning
Properly place defibrillation pads
Do not allow defibrillation pads to touch each
other, or to touch other electrodes, lead wires,
dressings, transdermal patches, etc. Such
contact can cause patient skin burns during
defibrillation and may divert defibrillating
current away from the heart.
Remove excessive
body hair, which may cause skin burns or
ineffective energy transfer. Do not use alcohol,
iodine or other skin preparations. These can dry
the skin and may cause the
AED7000 Plus to
function improperly or may cause skin burns.
Defibrilla
tor electrodes shall be kept well clear
of other electrodes or metal parts in contact
with the patient.
2.3.4 Electrical Energy
Warning
The
AED7000 Plus can deliver 200 joules of
electrical energy
Disconnect any medical electronic device that
is not
labeled "defibrillation protected" from
the patient. If this electrical energy is not
discharged properly, it could cause personal
injury or death to the operator or bystander.
During defibrillation, the operator and all other
people must stand clear of
the patient, bed and
all conductive surfaces in contact with the
patient.

14
Warning
Properly place defibrillation pads
Do not place electrodes near the generator of an
internal pacemaker. Always apply electrodes
to flat areas of skin. Avoid
application over
folds of skin such as those underneath the
breast or on obese patients. Excessive hair,
poor adhesion, or air under electrode may
produce burns.
2.3.5 ECG Misinterpretation
Warning
Properly place defibrillation pads
Improperly placed pads
may produce incorrect
analysis and an inappropriate shock or no shock
advisory decision.
Warning
Do not move patient
Handling or transporting the patient during
ECG analysis can cause incorrect or delayed
diagnosis. Follow all instructions in the
Users
Manual.
Warning
Cardiac pacemakers may affect rhythm
analysis
Patient pacemakers may reduce the sensitivity
of the
AED7000 Plus analysis and errors in
detecting shockable rhythms.
Warning
Radio frequency (RF) interference
Do not operate the
AED7000 Plus in
conjunction with electro
-cautery or diathermy
equipment. Any equipment that emits strong

15
radio frequency signals can cause electrical
interference and distort the ECG signal to cause
inaccurate interpretation of rhythm.
2.4 Defibrillator and Electrode Pads
2.4.1 Explosion
Warning
Explosion hazard
Possible explosion and fire hazard if used in the
presence of flammable agents or in an oxygen
enriched atmosphere.
2.4.2 Electrical Shock or Fire Hazard
Warning
No internal,
operator-serviceable parts
Do not open unit, remove covers or attempt to
repair the
AED7000 Plus. All servicing must
be performed by qualified personnel.
Warning
Improper use can cause injury
The
AED7000 Plus contains an automatic
disarm of the stored energy. If the operator
has not delivered the energy to a patient or a
test load, an internal timer will disarm the
stored energy. This stored electrical energy
can potentially cause death or injury if
discharg
ed improperly. Follow all instructions
in this User’s Manual.