Mach Power HC-AED7000 Manual de Usario

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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.
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2.7 Safety Symbols
Graphical symbols, letter symbols, and signs listed below may be found on the AED7000 and acces-
sories. 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
3. INTRODUCING 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 Semiautomatic External Defibrillator
3.1.1 Overview
The AED7000 Semiautomatic 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 ope-
rators 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 shockable situation exists and if appropriate, automa-
tically 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.
3.1.2 Features
AED7000 features include:
1. Three-step defibrillation process
2. Two-button operation
3. Extensive voice and visual prompts for the operator
4. Biphasic energy output
5. Lock-out protection to prevent inadvertent defibrillation
3.1.3 Qualified Operators
The AED7000 permits trained users to administer a brief electrical shock to patients experiencing
fibrillation or sudden cardiac arrest (SCA). A qualified operator is someone who has successfully
completed a CPR AED training course.
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Getting the AED7000 Automatic External Defibrillator Ready
Carefully unpack and inspect all the AED7000 system components and accessories. Install the
battery. Verify that the self-test passes before putting the unit into service. The device will perform an
automatic self test upon being turned on.
3.2 Unpacking and Inspecting
Visually inspect the carton for any signs of damage or mishandling (carton perforations, cuts, or
dents; bent or collapsed corners; or broken carton seal). Remove the AED7000 from the carton and
inspect it carefully.
Before proceeding:
1. Open and carefully unpack each carton.
2. Examine the instruments and accessories for signs of damage.
3. Check the packing list to determine that all accessories have been received.
4. Contact M&B, Service Department at (+86)10-61253747 if anything looks damaged or is missing.
3.2.1 Installing the Battery
The AED7000 uses an extended-life, Lithium non-rechargeable battery.
To install the battery:
1. Open the battery compartment (located near the bottom of the backside of the AED7000) by
removing the thumbscrews and then sliding the battery cover up and off.
2. Locate the 3 battery contact pins in the bottom-right comer of the battery compartment
3. Push the 3-pin battery connector onto the contact pins.
4. Place the battery into the battery compartment and replace the battery cover.
5. Slide the cover back so that the screw holes are aligned.
6. Replace the thumbscrews
3.2.2 Running a Self-Test
After installing the battery, the AED7000 powers up and performs a self-test. At power-up, the fol-
lowing tests are performed: battery, main processor, memory and program, ECG acquisition system,
and defibrillator.
3.3 Getting to Know the AED7000 Semiautomatic External Defibrillator
The AED7000 is an Semiautomatic external defibrillation (AED) device. It features a straightforward,
three-step operating design that uses extensive voice and visual prompts to assist the operator. This
defibrillator should not be used on patients less than 8 years old or under 25kg (55lbs), unless it is
equipped with the accessory AED 7000 Pediatric Energy Reducer
Functions
This section describes the following AED7000 features:
1. Controls
2. LED Prompts
3. Voice Prompts
4. Detailed information on using, and maintaining the AED7000 are presented in Chapters 5and 6,
respectively.
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3.4 User Interface
3.4.1 Controls
The AED7000 is designed for ease of operation. After putting the defibrillator pads on the patient
and connecting them to the AED7000, the operator performs this simple three-step process:
1. Turn the power ON.
2. Follow LED prompts on the panel and voice prompts from the speaker.
3. If prompted, deliver shock by pressing the flashing red Shock button.
Power ON/OFF: Green On/Off button to toggle system power on/off.
Shock: Red Shock button to discharge defibrillator, red LED flashes when defibrillator is fully char-
ged.
3.4.2 LED Prompts
Operating information and user instructions display in these light-emitting diodes.
Check Pad LED Flashes: Defibrillator pads are not properly attached to the patient or are not proper-
ly connected to the AED7000.
Caution LED Flashes Do not touch or move the patient.
Analyzing LED Flashes: ECG leads are properly connected and the system is assessing the patient’s
heart rhythm.
3.4.3 Voice Prompts
The AED7000 prompt feature provides instructional prompts to guide the user through the defibril-
lation process.
The AED7000 provides audio instructions through the built-in speaker to provide operating in-
struction and assist the user during defibrillation.
The voice prompts are listed in the following table.
1Check the electrodes
2Shock cancelled, check the electrodes.
3Shock delivered
4Time out, analysis restart.
5Analyzing, do not touch the patient.
6Charging, do not touch the patient
7No shock advised
8Press flashing shock button.
9Stop CPR, start analysis ten seconds later.
10 Low Battery
11 System failure
Patient may be touched. Carry on CPR. Alternately give 30 chest compressions and 2 mouth-to-
mouth breaths. Now give 30 chest compressions. Now give 2 mouth-to-mouth breaths (Four Cycles)
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3.4.4 Battery Level Indicator
The Power LED:
Power led is bright Indicates the charge left in the battery is full
Power LED flashes slowly Indicates the charge left in the battery is partially depleted.
Power LED flashes fast Indicates the charge left in the battery is low
3.5 AED7000 Semiautomatic External Defibrillator Accessories Part List
3.5.1 AED7000 Semiautomatic External Defibrillator
AED7000 Automatic External Defibrillator with one set of defibrillation pads, battery and user
manual.
3.5.2 AED7000 Automatic External Defibrillator Accessories
CR123A-4X2 M&B Battery Pack - Non-rechargeable LiMnO2 battery
EDC-2035 Set Of Two Multi-Function Electrodes
AED7000-101 AED7000 Automatic External Defibrillator User Manual.
AED7000-102 AED7000 Automatic External Defibrillator Carrying Case.
4. SELF-TEST FUNCTION INTRODUCTION
4.1 AED Front Cover (with Self-test)
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4.2 Introduction of AED self-test function
Daily-test: The built-in battery will be tested automatically each day
Monthly-Test: The AED7000 will perform a full self-test each month or following each battery chan-
ge.
The full self-test includes: battery test, charging & discharging test, data collection and data com-
munication test.
4.3 Self-test function description in detail
Daily-test: On commencement, the self-testing LED indicator will turn on; and automatically turn off
on completion of self test. The self-testing result will be displayed in battery LCD, as follows:
If the battery is low the following icon will appear
If the battery is in normal condition the following icon will appear
Monthly-test: On commencement, the self-testing LED indicator will turn on; when finished, the
self-testing LED indicator turns off. And the test result will appear in LCD:
If there is a fault with the AED7000 the following icon will appear
If the AED7000 is in optimal working order the following icon will appear
4.4 Actions required during AED Self-testing
1. The AED7000 will only function under normal operating condition if the following icon is shown:
2. Monthly-test when Battery changed
If the monthly self-test function is not required, please install the new battery within 10 seconds
following removal of the old battery
If the monthly self-test function is required, please install the new battery 20 seconds later following
removal of the old battery. The monthly self-test will commence one minute later after installation
of the new battery.
5. USING AED7000 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
5.1 Overview
This chapter provides information for using the AED7000.
Caution!
Before proceeding with this chapter, first read the safety section
The common operating procedures of the AED7000 are the several steps below:
1. Assess the patient
2. Start the AED7000
3. Attach the electrode pads to the patient
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4. Heart rhythm analyzing
5. Charging procedure
6. Discharging procedure
7. Cardiopulmonary resuscitation procedure(CPR)
8. An emergency cancellation
Pads socket
Indicator (Self-testing)
Indicator (Shock)
Shock Button
Power LED
ON/OFF Button
Indicator (Caution)
Indicator (Analyzing)
Speacker
Indicator (check pad)
5.2 Assess the patient
Before using the AED7000, the operator must first check the condition of the patient. The AED7000
can be used on a patient, only if all the following conditions are present:
- Unconsciousness
- Absence of breath
- If both the conditions above exist, the AED7000 should be used immediately.
5.3 Start the AED7000 Semiautomatic External Defibrillator
The operator should first start the AED7000 to check its working condition and power condition.
5.3.1 Checking power condition
Pressing the ON/OFF button for 2~3seconds to start the AED7000, the power indicator will turn on. If
the indicator is flickering, it means that the AED7000 is in the status of low power, and the current
battery should be replaced.
5.3.2 Check the working condition
After the AED7000 starts, the AED7000 will begin to check the condition of the pads connection.
Before the pads are properly connected, the AED7000 will prompt the operator to insert the con-
nector of the pads to the socket of the AED7000 and place the pads correctly on the patient.
Check the electrodes
If the pads are improperly connected, the indicator of “Check Pad” will be flickering
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The AED7000 takes 8~10seconds to complete analysis. Because the analyzing result depends on the
ECG waveform of the patient, which may be interrupted by any touching or moving the body of the
patient, any touch or movement may lead to an incorrect analysis result.
Warning!
Don’t touch or move the patient during the analysis period.
There are two possible analysis results. If defibrillation is advised, the AED7000 will start the charging
procedure; otherwise, a recommendation of Cardiopulmonary resuscitation procedure (CPR) will
begin.
5.6 Charging procedure
If the AED7000 determines that the patient requires defibrillation, the charging procedure will start.
During the charging procedure, Caution indicator and analyzing indicator will be
flickering
Charging, do not touch the patient.
Warning!
Do not touch the patient during the charging period
First
energy
level
Second
energy
level
Third
energy
level
2min CPR
2min CPR
2min CPR
The AED7000 has three energy of defibrillation，as shown in the table below:
First energy level 150J
Second energy level 150J
Third energy level 200J
The charging time depends on the energy of defibrillation
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If an unpredictable situation occurs, the operator should press the ON/OFF button for 2 seconds to
shut down the AED7000 and internally discharge all the power to the machine
6. MAINTAINING THE SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
The maintaining, cleaning and Troubleshooting of the AED7000 will be described in this section:
• Maintaining
• Cleaning and disinfecting
• Troubleshooting
6.1 Maintenance
Maintenance is required for the optimal operation of the AED7000. Maintenance should be perfor-
med periodically; with weekly or monthly inspections recommended.
The frequency of inspection:
It is recommended that the AED7000 is inspected once a week or twice a month, but if use of the
AED7000 is more frequent, additional inspections should be performed.
The table below describes a general rule to perform the inspection
Frequency of use (n / month) Inspection
1 / month Once a week
2 ~ 3 / month Twice a week
Infrequent using(1 ~ 2 a year) Once a month
Caution!
If the AED7000 should be used more than 4 times a month, we recommend
that the AED7000 should be inspected by authorized service personnel at
least twice a year
6.1.1 Inspection schedule
The general inspection schedules are described below. The operator should follow these schedules
when performing the inspection, as improper inspection may cause damage to the AED7000.
Check the status of indicator and the voice prompt.
If the AED7000 is started without electrode pads connection, the indicator of “Check pad” will be fli-
ckering and a voice prompt of “Check the electrode” will be broadcast. In the absence of either status
indicator above, contact the authorized service personnel for the necessary servicing or repair.
25
ENG
Warning!
If the conditions above are observed during the inspection of the AED7000,
the AED7000 must not be used on any patient.
6.1.2 Check the battery
The AED7000 begins to check the capacity of the battery when it starts. If the battery capacity is
low, the Power LED will be flickering, otherwise the indicator will be green.
If a low battery capacity occurs, replace the current battery with a new one.
1. Open the battery compartment by removing the thumbscrews and then sliding the battery cover
up and off.
2. Locate the 3 battery contact pins in the bottom-right corner of battery compartment.
3. Push the 3-pin battery connector onto the contact pins.
4. Place the battery into the battery compartment and replace the battery cover. Slide the cover
back so that the screw holes are aligned.
5. Replace the thumbscrews.
Warning!
We recommend replacing the battery provided by the AED7000 service provi-
der or one that matches the standard battery parameters of the AED7000
Warning!
The replaced battery doesn’t match the standard battery parameters may
cause serious damage to the AED7000.
6.1.3 Check the defibrillator electrodes
Inspect the packaging of any disposable DEFIBRILLATOR ELECTRODES to ensure integrity of any
seals and validity of any expiry date.
Charge the ENERGY STORAGE DEVICE once a year. Please contact our service centre or agencies to
organize this.
26
6.2 Cleaning and disinfecting
Cleaning and disinfecting of the AED7000 should be done frequently.
The followings are the guidelines of cleaning and disinfecting of the AED7000:
6.2.1 Cleaning
Before cleaning the AED7000, making sure that the AED7000 has been power off, because any clea-
ning with the machine powered on may cause a shock hazard to the cleaners.
We recommend that the cleaners use warm water to clean the AED7000. Other clean-
sers without strong solvents could also be used.
Caution!
Do not allow water or other cleaning products to enter the AED7000 unit
when cleaning the machine, as these liquids may cause damage to the
AED7000 or a shock hazard
Use a soft cloth to wipe the AED7000. Never clean the AED7000 with any type of brush.
Caution!
When cleaning the electrode pads socket of the AED7000, do not use excess
water or cleanser
6.2.2 Disinfecting
Disinfection of the AED7000 is recommended. Use only alcohol based solvents.
Caution!
Never use the following cleansers on the AED7000:
Acetone, Ammonia cleanser, Glutaraldehyde
6.3 Troubleshooting
As with any equipment, problems may occur during the operation of the AED7000. Indicators and
voice prompts will be given to the operator to indicate any identified issues with the unit.
General trouble shooting tips are noted below.
The operator could try to salve the problem which occurring prior to or during the
operation according to these trouble shootings beblow
6.3.1 The troubleshooting of attaching electrode pads
Problem description:
The voice prompt of “Check the electrode” continues to broadcast when the electrode pads
27
ENG
have been placed on the patient and the pads connector has been connect to the socket of the
AED7000.
Check the electrodes
Solution:
• If the electrode pads are dry, damaged or out-of-date, replace the current pads with new ones and
recommence.
• Ensure that the electrode pads have been properly adhered to the patient. If not attached correct-
ly, wipe off any water or moisture from the chest and shave the hair from chest area, then press the
pads firmly on the chest of the patient.
• Ensure the two pads do not touch each other.
• If the pads connector is inadequately connected to the socket of the AED7000, push the connector
firmly into the socket.
6.3.2 Troubleshooting of analysis
Problem description:
The analysis is interrupted during the analysis period, and the voice prompt of “Check the electrode”
is broadcast.
Solution:
• Shut down the AED7000 and check the pads placed on the patient, if they are not properly con-
nected, press the pads firmly on the chest of the patient, then start the AED7000 again.
• If the patient has moved during the analyzing period, shut down the AED7000 and immobilize the
patient if possible.
6.3.3 Troubleshooting of charging
Problem description:
The charging is stopped during the charging period, and the voice prompt of “Charging cancelled:
check the electrode” is broadcast.
Charging cancelled: check the electrodes.
Solution:
• Shut down the AED7000 and check pads connector. If the connector inadequately connects to the
socket of the AED7000, push the connector firmly into the socket.
• Shut down the AED7000 and check the pads contacting with patient’s bare chest. If the pads are
poorly contacted, wipe off any moisture and press the pads firmly on the chest of the patient.
6.3.4 Troubleshooting of defibrillation
Problem description:
The AED7000 automatically has an internal disarm function following completion of the analysis
process. The unit broadcasts a voice prompt of “Time out, analysis restart”.
28
Time out, analysis restart
Solution:
• If the operator doesn’t press the shock button in 30 seconds after the analysis is finished, the
AED7000 will automatically disarm.
• Press the shock button in 30 seconds after the voice prompts of “press flashing shock button”.
Press flashing shock button
6.3.5 Troubleshooting of battery
Problem description:
During the operation of the AED7000, the ON/OFF indicator is flickering.
Solution:
Shut down the AED7000 and replace the current battery with a new one.
7. SPECIFICATION
The Specification of physical, electronic isolation, defibrillator, battery, electromagnetic compatibility,
and rhythm recognition performance is described in this section:
• Physical
• Electronic isolation
• Defibrillator
• Battery
• Electromagnetic compatibility
• Rhythm recognition performance
7.1 Physical
Category Specification
Dimensions 303 x 216 x 89 mm
Weight 2.0 kg
Operating Temperature 0°C -40°C
Operating Humidity Relative humidity between 30% and 95% (non-con-
densing)
Altitude -91m a 4573m (-300 a 15,000 ft)
Pressure 102.4kPa~57.2kPa (768mmHg~429mmHg)
Storage Temperature -20°C a 50°C (without battery)
Storage Humidity Up to 95% (without battery and non-condensing)
29
ENG
7.2 Electrical Isolation
Category Specification
Power Unit operates on internal battery only
External Electrical Connections No external devices are attached to the unit
Risk Current Category
Internally powered equipment with defibrillator-proof
BF type patient applied part (as per definition of IEC
60601-1 standard)
7.3 Defibrillator
Output Specification
Energy Sequence Biphasic Truncated exponential (user configurable)
150J, 150J, 200J
Charge Time from “Shock Advised” 10 sec. to 150J
15 sec. to 200J
Analysis Time 9 sec
From start of analysis to shock ready Less than 20 seconds from power up
Less than 25 seconds after 6 shocks
Audible Prompts LED prompts
Visual Prompts LED prompts
Controls Two buttons - ON/OFF, Shock
Output Energy Accuracy ±15% into any impedance from 25 to 175Ω
Patient impedance 20Ω a 200Ω
Waveform details
The table below provides details of the biphasic truncated exponential waveform delivered by the
AED7000 (set to 200J) when connected to resistive loads of 25 through 175 Ohms. The waveforms are
characterized by typical values for peak current (Ip), duration of the first output phase, and duration
of the second output phase. Values are within 10%.
Output Energy
(J)
Patient
Impedance (Ω)
Ip1
(Amps)
Ip2
(Amps)
Phase1
(ms)
Phase2
(ms)
Interval
(ms)
200
25 46 34.0 5.5 3.3 0.7
50 23 17.0 10.9 6.6 0.7
75 15.3 11.3 16.3 8.9 0.7
100 11.5 8.5 19.7 9.6 0.7
125 9.2 6.8 20.5 11.2 0.7
150 5.8 19.8 10 0.77.6
175 6.5 5.2 19.8 10 0.7
30
Pediatric Energy Reducer: Energy Attenuation Factor
50% 25 Ω
25% 50Ω and 75Ω
20% 100Ω and 125Ω
15% 150Ω and 175Ω
7.4 Battery
Category Specification
Part No CR123A-4x2
Non-rechargeable 12V d.c. 2.8Ah
Capacity 100 discharges at 200J or 120 discharges at 150J
Shelf Life 5 years (25°C ± 15°C)
Battery capacity measured according to IEC 60601-2-4, clause 102.3.2 at room tempe-
rature. Capacity may be diminished at operating temperature extremes, or when the
available battery charge is used in multiple power ON/OFF cycles.
7.5 Electrodes
Do not use defibrillation pads not approved by M&B. Use of unauthorized defibrillation
pads may cause the device to operate improperly and provide false measurements.
Follow all labeling instructions on the defibrillation pads
7.6 Guidance and manufacturer’s declaration
7.6.1 Electromagnetic emissions (IEC 60601-1-2 Table 201)
The AED7000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the AED7000 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment
guidance
RF emissions
CISPR 11 Group 1
TheAED7000 uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11 Class B
Harmonic emissions IEC
61000-3-2 Not applicable
Voltage fluctuations/ flicker
emissions IEC 61000-3-3 Not applicable
Medical Electrical Equipment requires special precautions regarding EMC and must be installed and
put into service according to EMC information provided in this document.
31
ENG
7.6.2 Electromagnetic immunity (IEC 60601-1-2 Table 202)
The AED7000 is intended for use in the electromagnetic environment specified below. The custo-
mer or the user of the AED7000 should ensure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
Not applicable
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
Not applicable
Voltage dips,
short inter-
ruptions and vol-
tage variations
on power supply
input lines
IEC 61000-4-11
<5% UT(>95%
dip in UT) for 0.5
cycle
40% UT (60% dip
in UT) for 5 cycles
70% UT (30%
dip in UT) for 25
cycles
<5% UT (>95 %
dip in UT) for
5 sec
Not applicable
Power frequency
(50/60 Hz) ma-
gnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
UT is the AC mains voltage prior to application of the test level.
32
7.6.3 Electromagnetic immunity (IEC 60601-1-2 Table 203)
The AED7000 is intended for use in the electromagnetic environment specified below. The customer
or the user of the AED7000 should ensure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment
guidance
Radiated RF IEC
61000-4-3
10V/m 80 MHz a
2.5 GHz 20V/m
Portable and mobile RF communications
equipment should be used no closer
to any part of the AED7000, inclu-
ding cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance :
80MHz a 800MHz
800MHz a 2.5GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
and d is the recommended separation
distance in meters (m). b
Field strengths from fixed RF transmit-
ters, as determined by an electroma-
gnetic site survey c, should be less than
the compliance level in each frequency
range d. Interference may occur in the
vicinity of equipment marked with the
following symbol:
At 80 MHz and 800 MHz, the higher frequency range applies
These guidelines may not apply in all situations. Electromagnetic propagation is af-
fected by absorption and reflection from structures, objects and people
a. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz
to6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile or portable
communications equipment could cause interference if it is inadvertently brought into patient
areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation
distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular or cordless) telepho-
nes and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
33
ENG
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength
in the location in which the AED7000 is used exceeds the applicable RF compliance level above,
the AED 7000 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the AED 7000.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
7.6.4 Recommended separation distances between portable and mobile RF communications
equipment and the AED7000 (IEC 60601-1-2 Table 205)
The AED7000 is intended for use in an environment in which radiated RF disturbances are control-
led. The customer or the user of the AED7000 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) mad the AED7000 as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter W
Separation distance according to frequency of transmitter m
80MHz a 800MHz
d= 0.6 • √P
80MHz a 2.5GHz
d= 1.15 • √P
0.01 0.115 0.115
0.1 0.364 0.364
1 1.15 1.15
10 3.637 3.637
100 11.5 11.5
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap-
plies.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.
An additional factor of 10/3 is used in calculating the recommended separation distan-
ce for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in
the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into
patient areas
These guidelines may not apply in all situations. Electromagnetic propagation is af-
fected by absorption and reflection from structures, objects and people
34
7.7 Rhythm Recognition Performance
The AED7000 algorithm exceeds the requirements of ANSI/AAMI DF39-1993.
Section 3.3.18 and the sensitivity and specificity levels recommended by the AHA Semiautomatic
External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhyth-
mia Analysis Algorithm Performance.
The test database includes shockable rhythms consisting of ventricular fibrillation rhythms (>150uV)
and wide-complex ventricular tachycardia at a rate greater than 140 BPM. Non-shockable rhythms
include various sinus rhythms including supraventricular tachycardia, atrial fibrillation, atrial flutter,
sinus rhythm with PVC’s, asystole, pacemaker rhythms, and ventricular tachycardia with a rate less
than 140 BPM and/or narrow complexes.
Rhythms Test Sample
Size
Performance
Goal Conclusion
Shockable:
VF 1067 >90% sensitivity Meets the AAMI DF39 requirement
and AHA recommendation
Shockable:
VT 22 >75% sensitivity Meets the AAMI DF39 requirement
and AHA recommendation
Nonshockable:
NSR 4000 >99% sensitivity
(AHA)
Meets the AAMI DF39 requirement
and AHA recommendation
Nonshockable:
asystole 179 >95% sensitivity Meets the AAMI DF39 requirement
and AHA recommendation
Nonshockable:
all other rhythms 25732 >95% sensitivity Meets the AAMI DF39 requirement
and AHA recommendation
8. GLOSSARY
AED Semiautomatic external defibrillator
AHA American Heart Association
ALS advanced life support
Arrhythmia Irregular rhythm of the heart muscle
Cardiac arrest Cessation of the heart muscle
CPR Cardiopulmonary resuscitation
Defibrillation High-energy pulse of electricity (shock) delivered to the heart muscle
to restore normal cardiac activity
ECG Electrocardiogram
Electrocardiogram Electrocardiogram
35
ENG
Electrocardiogram Instrument used to record electrical currents associated with heart
muscle activity
Fibrillation Rapid twitching movements that replace the normal rhythmic con-
traction of the heart and may cause a lack of circulation and pulse
Joule The amount of energy delivered during defibrillation, related to the
intensity of the shock delivered.
Log List of ECG samples and time-stamped system events
Non-shockable rhythm Patient heart rhythms that are not a candidate for defibrillation pulse
NSR Normal sinus rhythm
RF Radio frequency
SCA Sudden cardiac arrest
Self-test Automatic test performed at system power-up to check readiness of
battery, internal circuitry, main processor, and defibrillator
Shock Defibrillation electrical pulse
Shockable rhythm Abnormal heart rhythm which is a candidate for defibrillation pulse
Tachycardia An abnormally fast heart rate
Time-stamped event Any change in heart rhythm or any shock delivered by the defibrilla-
tor
37
ITA
37
1 Prefazione
1.1 Produttore
1.2 Responsabilità del produttore
1.3 Responsabilità dell’utente
1.4 Contattare assistenza tecnica
1.5 Dichiarazione di conformità
1.6 Etichette
2 Sicurezza
2.1 Convenzioni utilizzate nel manuale
2.2 Precauzioni e avvisi generali
2.3 Sicurezza del paziente
2.4 Defibrillatore ed elettrodi
2.5 Batteria
2.6 Cura e conservazione
2.7 Simboli di sicurezza
3 Presentazione dell’AED7000
3.1 Panoramica del defibrillatore
3.2 Disimballaggio ed ispezione
3.3 Conoscenza del defibrillatore
3.4 Interfaccia utente
3.5 Elenco delle parti degli accessori per il defibrillatore
4 Introduzione alla funzione di autotest
4.1 Coperchio anteriore DAE (con autotest)
4.2 Introduzione della funzione di auto-test DAE
4.3 Descrizione dettagliata della funzione di autotest
4.4 Azioni richieste durante l’autotest del DAE
5 Utilizzo del defibrillatore
5.1 Panoramica
5.2 Valutare il paziente
5.3 Avviare il defibrillatore
5.4 Artaccare gli elettrodi al paziente
5.5 Analisi del ritmo cardiaco
40
40
40
40
40
40
41
42
42
43
44
45
47
47
48
48
48
49
49
50
51
52
52
52
52
53
53
53
54
54
54
55
...
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...
...
INDICE
38
5.6 Procedura di ricarica
5.7 Procedura di scarica
5.8 Procedura di rianimazione cardiopolmonare (RCP)
5.9 Cancellazione di emergenza
6 Manutenzione del defibrillatore
6.1 Manutenzione
6.2 Pulizia e disinfezione
6.3 Risoluzione dei problemi
7 Specifiche
7.1 Fisiche
7.2 Isolamento elettrico
7.3 Defibrillatore
7.4 Batteria
7.5 Elettrodi
7.6 Linee guida e dichiarazione del produttore
7.7 Prestazioni di riconoscimento del ritmo
8 Glossario
55
56
57
58
58
58
60
61
63
63
63
63
64
65
65
68
69
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39
ITA
4040
1. PREFAZIONE
Non provare ad utilizzare questa apparecchiatura senza leggere e comprendere a
fondo queste istruzioni.
1.1 Produttore
Produttore: 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
Nome prodotto Automatic External Defibrillator
Tipo dispositivo AED7000
1.2 Responsabilità del produttore
M&B (Beijing M&B Electronic Instruments, Co., Ltd) è responsabile della sicurezza, affidabilità e
prestazioni del defibrillatore semiautomatico esterno AED7000, solo se sono rispettate le seguenti
condizioni:
Le operazioni di assemblaggio, miglioramento, riadattamento , modifica o riparazione vengono ese-
guite da persone autorizzate da M&B.
Il defibrillatore semiautomatico esterno AED7000 viene utilizzato secondo le istruzioni per l’uso.
1.3 Responsabilità dell’utente
Il defibrillatore semiautomatico esterno AED7000 è destinato all’uso da parte di personale autorizza-
to da un medico / direttore medico e che ha ricevuto una formazione sull’uso di un DAE.
L’utente deve essere completamente al corrente delle informazioni contenute nel Manuale d’uso del
defibrillatore semiautomatico esterno AED7000. Come con tutti gli altri monitor elettronici per la
cura del paziente, è necessario utilizzare un buon giudizio clinico quando si utilizza il defibrillatore
semiautomatico esterno AED7000. Per garantire la sicurezza del paziente e il corretto funzionamen-
to, utilizzare solo parti e accessori autorizzati dal produttore.
L’utente deve conservare tutte le confezioni originali e i materiali di imballaggio. Durante la spedizio-
ne dell’AED7000 e degli accessori per la calibrazione, l’assistenza o gli aggiornamenti, è necessario
utilizzare i confezioni e i materiali di imballaggio originali.
1.4 Contattare assistenza tecnica
Si prega di contattare M&B in caso di domande in merito a questo avviso
Telefono: +86 10 6125 3747
Fax: +86 10 6125 3794
Sito web: www.mbelec.com
E-mail: service@mbelec.com
1.5 Dichiarazione di conformità
Produttore: Beijing M&B Electronic Instruments, Co., Ltd

Especificaciones del producto

Marca: Mach Power
Categoría: No categorizado
Modelo: HC-AED7000

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