Mach Power HC-EDCP235 Manual


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User Manual
Semi-automatic external defibrillator
HC-AED7000
AED7000
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 PEOPLE’S REPUBLIC OF CHINA
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 2057 Hamburg, Germany
Imported by / Importato da:
Mach Power Italy s.r.l.: Via Alberigo Albricci, 8 - 20122 Milano (MI) Italy
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1 Preface
1.1 Manufacturer
1.2 Manufacturer’s Responsibility
1.3 User’s Responsibility
1.4 Contact and Technical Support
1.5 Declaration of Conformity
1.6 Labels
2 Safety
2.1 Conventions Used in the Manual
2.2 General Cautions and Notices
2.3 Patient Safety
2.4 Defibrillator and Electrode Pads
2.5 Battery
2.6 Care and Storage
2.7 Safety Symbols
3 Introducing the aed7000
3.1 Overview of the AED7000 Semiautomatic External Defibrillator
3.2 Unpacking and Inspecting
3.3 Getting to Know the AED7000 Semiautomatic External Defibrillator
3.4 User Interface
3.5 AED7000 Semiautomatic External Defibrillator Accessories Part List
4 Self-test function introduction
4.1 AED Front Cover (with Self-test)
4.2 Introduction of AED self-test function
4.3 Self-test function description in detail
4.4 Actions required during AED Self-testing
5 Using AED7000 semiautomatic external defibrillator
5.1 Overview
5.2 Assess the patient
5.3 Start the AED7000 Semiautomatic External Defibrillator
5.4 Attach the electrode pads to the patient
5.5 Heart rhythm analyzing
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INDEX
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5.6 Charging procedure
5.7 Discharging Procedure
5.8 Cardiopulmonary resuscitation procedure (CPR)
5.9 An emergency cancellation
6 Maintaining the semiautomatic external defibrillator
6.1 Maintenance
6.2 Cleaning and disinfecting
6.3 Troubleshooting
7 Specification
7.1 Physical
7.2 Electronic isolation
7.3 Defibrillator
7.4 Battery
7.5 Electrodes
7.6 Guidance and manufacturer’s declaration
7.7 Rhythm recognition performance
8 Glossary
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1. PREFACE
Do not attempt to use this equipment without thoroughly reading and under-
standing 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 per-
formance of the AED7000 Semiautomatic 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 Semiautomatic External Defibrillator equipment is used in accordance with the
instructions for use.
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 Se-
miautomatic External Defibrillator Users Manual. As with all other electronic patient care monitor,
good clinical judgment should be used when operating the AED7000 Semiautomatic 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 ma-
terials must be used.
1.4 Contact and Technical Support
Please contact M&B if you have any questions regarding this notice
Telephone: +86 10 6125 3747
Fax: +86 10 6125 3794
Internet: www.mbelec.com
E-mail: service@mbelec.com
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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 PEOPLE’S REPUBLIC OF CHINA
Product Name Automatic External Defibrillator
Device Type AED7000
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
Compliance Complies with Council Directive 93/42/EEC (Medical Device Directive) of
June 14 1993 class IIb Annex II
1.5.2 Standard
General
ISO13485 2003
ISO14155 2003
ISO14971 2007
EN980 2008
EN1041 1998
Sicurezza IEC60601-1:1988+A1:1991+A2:1995+A13:1996 Type BF, Internally Powered, Conti-
nuous 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
CE Mark
BF and Defibrillation-proof applied parts
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Change batteries
Batteries
Caution
Serial number
Date of manufacture
Europe representative
2. SAFETY
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, or loss of data.
2.1.3 Notes
Notes contain information that augments or clarifies an operating step. Notes do not normally con-
tain actions. They follow the procedural steps to which they refer. In this manual, notes are displayed
as shown in the following example:
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Note!
If the AED7000 is used more than once per month, it is recommended that autho-
rized 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 in-
structions 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
1. General Cautions and Notices
2. Patient Safety
3. Defibrillator and Electrode Pads
4. Battery
5. Care and Storage
6. Safety Symbols
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 person-
nel 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 ma-
gnetic 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 Label
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.
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
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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 ensu-
re all external devices used near the AED7000 comply with EMC demands.
2.3 Patient Safety
2.3.1 General
Accessory adapter required for use on pediatric patients.
The 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.
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.
2.3.2 Shock Hazard
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 DEFIBRILLA-
TION-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.
2.3.3 Burn
Properly place defibrillation pads
Do not allow defibrillation pads to touch each other, or to touch other electrodes, lead wi-
res, 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 con-
tact with the patient.
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2.3.4 Electrical Energy
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 perso-
nal 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.
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 underne-
ath the breast or on obese patients. Excessive hair, poor adhesion, or air under electrode
may produce burns.
2.3.5 ECG Misinterpretation
Properly place defibrillation pads
Improperly placed pads may produce incorrect analysis and an inappropriate shock or no
shock advisory decision.
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.
Cardiac pacemakers may affect rhythm analysis
Patient pacemakers may reduce the sensitivity of the AED7000 analysis and errors in
detecting shockable rhythms.
Radio frequency (RF) interference
Do not operate the AED7000 in conjunction with electro-cautery or diathermy equi-
pment. Any equipment that emits strong 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
Explosion hazard
Possible explosion and fire hazard if used in the presence of flammable agents or in an
oxygen enriched atmosphere.
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2.4.2 Electrical Shock or Fire Hazard
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.
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.
Do not immerse or expose the AED7000 to water or other liquids
Do not use the defibrillator if the unit has been immersed in liquid or if excessive conden-
sation is visible on the device.
Conductive parts should not contact other conductive parts including the earth
2.4.3 Improper Device Performance
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 compres-
sions (CPR) through electrodes. These actions may damage the electrode pads and cause
the unit to function improperly.
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.
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
Improper maintenance can cause improper performance
Follow instructions in the Users Manual.
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2.5 Battery
2.5.1 Battery care
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.
Always verify remaining capacity of a non-rechargeable battery after use
Check capacity and change if battery is low.
Replace battery at 5 years
Battery replacement at 5 years is recommended due to degradation of the battery chemi-
stry. Periodic maintenance and testing is highly recommended to ensure proper battery
performance.
2.6 Care and Storage
2.6.1 Cleaning and Sterilization
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 autocla-
ve the AED7000 or attempt to sterilize the AED7000 or any of its accessories.
2.6.2 Electrodes
Follow manufacturer’s instructions for use of defibrillation electrodes
Improper use of defibrillation electrodes may cause the AED7000 to function improperly
or may cause skin burns. Do not use expired, dry electrodes. Do not reuse disposable
electrodes. Only use M&B approved electrodes.
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
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.


Produkt Specifikationer

Mærke: Mach Power
Kategori: Ikke kategoriseret
Model: HC-EDCP235

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