M&B AED7000 User manual

GLCX-06-AED7000-05
AED7000 Automatic External
Defibrillator
Users Manual
V2.7
M&B Part Number AED7000-101 – Revision 2.7

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 LABELS ..........................................................................................................................................3
2Safety ..........................................................................................................5
2.1 CONVENTIONS USED IN THE MANUAL ...........................................................................................5
2.2 GENERAL CAUTIONS AND NOTICES ...............................................................................................7
2.3 2.3 PATIENT SAFETY......................................................................................................................8
2.4 DEFIBRILLATOR AND ELECTRODE PADS ......................................................................................12
2.5 BATTERY .....................................................................................................................................14
2.6 CARE AND STORAGE ....................................................................................................................14
2.7 SAFETY SYMBOLS........................................................................................................................15
3Introducing the AED7000................................................................. 17
3.1 OVERVIEW OF THE AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR......................................17
3.2 GETTING THE AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR READY .................................19
3.3 GETTING TO KNOW THE AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR..............................20
3.4 USER INTERFACE .........................................................................................................................20
3.5 AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR ACCESSORIES PART LIST ............................22
4Self-test Function Introduction ...................................................... 24
4.1 AED FRONT COVER (WITH SELF-TEST) .......................................................................................24
4.2 INTRODUCTION OF AED SELF-TEST FUNCTION.............................................................................24
4.3 SELF-TEST FUNCTION DESCRIPTION IN DETAIL .............................................................................25
4.4 ACTIONS REQUIRED DURING AED SELF-TESTING ........................................................................25

5Using the AED7000 Automatic External
Defibrillator................................................................................................. 26
5.1 OVERVIEW ...................................................................................................................................26
5.2 ASSESS THE PATIENT....................................................................................................................27
5.3 START THE AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR..................................................27
5.4 ATTACH THE ELECTRODE PADS TO THE PATIENT..........................................................................28
5.5 HEART RHYTHM ANALYZING.......................................................................................................29
5.6 CHARGING PROCEDURE................................................................................................................30
5.7 DISCHARGING PROCEDURE ..........................................................................................................31
5.8 CARDIOPULMONARY RESUSCITATION PROCEDURE (CPR)............................................................32
5.9 AN EMERGENCY CANCELLATION..................................................................................................34
6Maintaining the Automatic External Defibrillator................... 35
6.1 MAINTENANCE.............................................................................................................................35
6.2 CLEANING AND DISINFECTING......................................................................................................38
6.3 TROUBLESHOOTING .....................................................................................................................39
7Specification.......................................................................................... 43
7.1 PHYSICAL.....................................................................................................................................43
7.2 ELECTRICAL ISOLATION...............................................................................................................43
7.3 DEFIBRILLATOR ...........................................................................................................................44
7.4 BATTERY .....................................................................................................................................45
7.5 ELECTRODES................................................................................................................................46
7.6 GUIDANCE AND MANUFACTURER'S DECLARATION.......................................................................46
7.7 RHYTHM RECOGNITION PERFORMANCE.......................................................................................51
8Glossary .................................................................................................. 53

1
1Preface
Do not attempt to use this equipment without thoroughly reading
and understanding these instructions.
1.1 Manufacturer
Manufacturer 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
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 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 Automatic External Defibrillator equipment is used in accordance
with the instructions for use.

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1.3 User's Responsibility
The AED7000 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 Automatic External Defibrillator Users Manual. As with all other
electronic patient care monitor, good clinical judgment should be used when
operating the AED7000 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 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
Daxing District
102629 Beijing

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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
Accessories: See list in manual
Complies with Council Directive 93/42/EEC (Medical Device Directive) of
June 14 1993 class IIb Annex II
1.5.2 Standards
General: ISO13485:2003
ISO14155:2003
ISO14971:2007
EN980:2008
EN1041:1998
Safety: IEC60601-1:1988+A1:1991+A2:1995+A13:1996
Type BF, Internally Powered, Continuous
operation, Defibrillator Proof Operation
IEC60601-1-4:2000
IEC60601-1-6:2006
IEC60601-2-4:2002
IEC62304:2006
EMC: IEC60601-1-2:2007
1.6 Labels
Trademark
Manufacturer

4
CE Mark
BF and
Defibrillation-proof
applied parts
Change batteries
Batteries
Caution
Serial number
Date of manufacture
Europe representative
·

5
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 theequipment. 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, or
loss of data.

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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 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 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

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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 may not meet performance specifications if stored, transported or
used outside the specified storage or operating environmental range limits.
2.2.5 Notices
If the battery pack is removed for any reason, the user must label the AED7000 as
"Out of service due to battery operation."

8
Do not use mobile phones near the AED7000 as the radiation field produced by
mobile phones will interfere with the functioning of the AED7000.
A warning that the AED7000 should not be used adjacent to or stacked with other
equipment and that if adjacent to or stacked use is necessary, the AED7000 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 comply
with EMC demands.
2.3 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
accessory AED 7000 Pediatric Energy
Reducer.
Caution
Patient Physical Harm
Place the AED7000 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.

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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 unwanted
pathways for the defibrillating current.

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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 to function improperly or may cause
skin burns.
Defibrillator 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 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.

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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 affec
t rhythm
analysis
Patient pacemakers may reduce the sensitivity
of the AED7000 analysis and errors in
detecting shockable rhythms.
Warning
Radio frequency (RF) interference
Do not operate the AED7000 in conjunction
with electro-cautery or diathermy equipment.
Any equipment that emits strong radio

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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. All servicing must be
performed by qualified personnel.
Warning
Improper use can cause injury
The AED7000 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 discharged improperly.
Follow all instructions in this User’s Manual.
Caution
Do not immerse or expose the AED7000 to

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water or other liquids
Do not use the defibrillator if the unit has been
immersed in liquid or if excessive
condensation is visible on the device.
Caution
Conductive parts should not contact other
conductive parts including the earth
2.4.3 Improper Device Performance
Warning
Properly use electrode pads
Do not attempt to warm the electrodes with a
heat source greater than 35°C (95°F). Do not
immerse or clean electrodes with alcohol or
solvents. Do not perform chest compressions
(CPR) through electrodes. These actions may
damage the electrode pads and cause the unit to
function improperly.
Warning
Use only M&B approved accessories
Do not use defibrillation pads, batteries, and
other accessories not approved by M&B. Use
of unauthorized accessories may cause the
device to operate improperly and provide false
measurements. Follow all labeling instructions
on the defibrillation pads and the battery.
Caution
Do not repeatedly charge and discharge
defibrillator in rapid succession
If a need for repetitive testing arises, wait at
least 1 minute for every third discharge to
avoid damaging equipment.
Caution
Improper maintenance can cause improper
performance

14
Follow instructions in the Users Manual.
2.5 Battery
2.5.1 Battery Care
Caution
Use only M&B batteries
Use only M&B Part No. CR123A-4x 2
non-rechargeable lithium batteries. Use of any
other battery can damage the AED7000.
Caution
Always verify remaining capacity of a
non
-rechargeable battery after use
Check capacity and change if battery is low.
Caution
Repla
ce battery at 5 years
Battery replacement at 5 years is recommended
due to degradation of the battery chemistry.
Periodic maintenance and testing is highly
recommended to ensure proper battery
performance.
2.6 Care and Storage
2.6.1 Cleaning and Sterilization
Caution
Clean and maintain the AED7000 according to
instructions. See Chapter 4, Maintaining the
AED7000 Automatic External Defibrillator.
Do not clean the AED7000 with alcohol,
ketone, or any flammable agent. Do not
autoclave the AED7000 or attempt to sterilize
the AED7000 or any of its accessories.

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2.6.2 Electrodes
Warning
Follow manufacturer's instructions for use of
defibrillation electrodes
Improper use of defibrillation electrodes may
cause the AED7000 to function improperly or
maycause skin burns. Do not useexpired, dry
electrodes. Do not reuse disposable
electrodes. Only use M&B approved
electrodes.
Caution
Properly store and use defibrillation pads
Store electrodes in a cool, dry location
(between -4° and 131°F or -20°C and 55°C).
Do not sterilize the pads, immerse, or clean the
electrodes with alcohol or solvents.
2.6.3 Disposal
Warning
Disposal of device and its accessories
Please dispose of the device and its accessories
which have exceeded their operating time
according to relevant regulations. If you have
any question on device disposal or need more
detailed information, please contact us or our
service centers.
2.7 Safety Symbols

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Graphical symbols, letter symbols, and signs listed below may be found on the
AED7000 and accessories. Please note the use of these symbols for safe and proper
use of the equipment.
For a list of icons that display operating status information, see Chapter 3
Introducing the AED7000.
Attention, consult accompanying documents
Defibrillator protected type BF applied part.
Dangerous voltage

17
3Introducing the AED7000
This chapter provides an introduction to the AED7000 system and presents an
overview of the AED7000 controls, indicators, displays, and prompts. It also
provides instructions for getting the AED7000 ready for use and preparing the unit
for storage.
3.1 Overview of the AED7000 Automatic External Defibrillator
3.1.1 Overview
The AED7000 Automatic External Defibrillator is a safe, easy to use defibrillation
device. The unit is lightweight and mobile and can be used in situations where
there could be several minutes before the arrival of advanced life support (ALS)
personnel.
The AED7000 recognizes ventricular fibrillation and other ventricular tachycardia
and guides operators through the defibrillation process. When properly connected
to a patient who is unconscious, not breathing, and without a pulse, the AED7000
analyzes the patient's heart rhythm, provides text and audio instruction prompts,
determines if a shockablesituation exists and if appropriate, automatically arms the
Shock button.
The AED7000 delivers the defibrillation shock through two self-adhesive,
pre-gelled, low-impedance electrode defibrillator pads. The pads, cable, and
connector are sold as disposable kits.
The AED7000 is designed for infrequent use. This term is used to describe a
defibrillator designed to endure less than 2500 discharges.