Related Manuals for M&B AED7000
Summary of Contents for M&B AED7000
- Page 1 GLCX-06-AED7000-05 AED7000 Automatic External Defibrillator Users Manual V2.7 M&B Part Number AED7000-101 – Revision 2.7...
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Page 2: Table Of Contents
............................. 14 ATTERY 2.6 C ........................14 ARE AND TORAGE 2.7 S ........................15 AFETY YMBOLS 3 Introducing the AED7000 ..............17 3.1 O AED7000 A ........17 VERVIEW OF THE UTOMATIC XTERNAL EFIBRILLATOR 3.2 G AED7000 A ......... 19... - Page 3 5 Using the AED7000 Automatic External Defibrillator ....................26 5.1 O ........................... 26 VERVIEW 5.2 A ........................27 SSESS THE PATIENT 5.3 S AED7000 A ..........27 TART THE UTOMATIC XTERNAL EFIBRILLATOR 5.4 A ................28 TTACH THE ELECTRODE PADS TO THE PATIENT 5.5 H...
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Page 4: Preface
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. -
Page 5: User's Responsibility
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. -
Page 6: Labels
PEOPLE'S REPUBLIC OF CHINA 1.5.1 Declares that the CE-marketed product Product Name: Automatic External Defibrillator Device Type: 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... - Page 7 CE Mark BF and Defibrillation-proof applied parts Change batteries Batteries Caution Serial number Date of manufacture Europe representative·...
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Page 8: Safety
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. - Page 9 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.
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Page 10: General Cautions And Notices
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."... -
Page 11: Patient Safety
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. - Page 12 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.
- Page 13 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.
- Page 14 Manual. Warning Cardiac pacemakers may affect 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.
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Page 15: Defibrillator And Electrode Pads
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... - Page 16 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).
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Page 17: Battery
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. -
Page 18: Safety Symbols
Warning 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. - Page 19 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.
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Page 20: Introducing The Aed7000
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 shockable situation exists and if appropriate, automatically arms the Shock button. - Page 21 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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Page 22: Getting The Aed7000 Automatic External Defibrillator Ready
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. -
Page 23: Getting To Know The Aed7000 Automatic External Defibrillator
6. Replace the thumbscrews 3.2.3 Running a Self-Test After installing the battery, the AED7000 powers up and performs a self-test. At power-up, the following tests are performed: battery, main processor, memory and program, ECG acquisition system, and defibrillator. Getting to Know the AED7000 Automatic External Defibrillator The AED7000 is an automatic external defibrillation (AED) device. - Page 24 3.4.3 Voice Prompts The AED7000 prompt feature provides instructional prompts to guide the user through the defibrillation process. The AED7000 provides audio instructions through the built-in speaker to provide operating instruction and assist the user during defibrillation.
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Page 25: Aed7000 Automatic External Defibrillator Accessories Part List
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. AED7000 Automatic External Defibrillator Accessories Part List 3.5.1 AED7000 Automatic External Defibrillator... - Page 26 AED7000-00 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 LiMnO battery EDC-1035 Set Of Two Multi-Function Electrodes. AED7000-101 AED7000 Automatic External Defibrillator User Manual.
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Page 27: Self-Test Function Introduction
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 change. The full self-test includes: battery test, charging & discharging test, data collection and data communication test. -
Page 28: Self-Test Function Description In Detail
LED indicator turns off. And the test result will appear in LCD a. If there is a fault with the AED7000 the following icon will appear: b. If the AED7000 is in optimal working order the following icon will appear: 4.4 Actions required during AED Self-testing... -
Page 29: Using The Aed7000 Automatic External
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: Assess the patient Start the AED7000 Attach the electrode pads to the patient... -
Page 30: Assess The Patient
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. -
Page 31: Attach The Electrode Pads To The Patient
“Check Pad” will be flickering. No voice prompt or indicator flickering following the start of the AED7000, indicates an internal error of the AED7000 unit, and should not be used on any patient. 5.4 Attach the electrode pads to the patient The electrode pads must be correctly placed on the patient. -
Page 32: Heart Rhythm Analyzing
Peel off the backing from the electrode pad labeled LL, place this pad over the ribs on the patient’s left side below the breast. Plug the connector of the electrode pads into the socket of the AED7000 Automatic External Defibrillator. -
Page 33: Charging Procedure
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. -
Page 34: Discharging Procedure
The first prompt advises to stand clear of the patient. The operator should stand clear of the patient before pressing the shock button. Press flashing shock button. This prompt will be broadcast repeatedly to indicate that the AED7000 is ready to deliver a shock. -
Page 35: Cardiopulmonary Resuscitation Procedure (Cpr)
Deliver a shock: To deliver a shock, the several steps below must be obeyed: Make sure the indicator of shock button is flashing, which means the AED7000 is properly charged. Before pressing the shock button, make sure no one is touching the body of the patient. - Page 36 No shock advised During the period of charging, if the AED7000 detects that the shockable rhythm has changed to a normal one, the AED7000 will stop current procedure and switch to CPR procedure. The operator can touch the body of the patient and check their conditions.
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Page 37: An Emergency Cancellation
At the end of 10 seconds of CPR, the AED7000 will give a prompt to indicate that the operator must stop CPR and not touch the patient so that the AED7000 can restart a heart rhythm analysis and determine if a shockable rhythm condition exists. -
Page 38: Maintaining The Automatic External Defibrillator
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. - Page 39 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...
- Page 40 Replace the thumbscrews. Caution We recommend replacing the battery provided by the AED7000 service provider 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.
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Page 41: Cleaning And Disinfecting
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. -
Page 42: Troubleshooting
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. - Page 43 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 connected, press the pads firmly on the chest of the patient, then start the AED7000 again.
- Page 44 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.
- Page 45 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.
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Page 46: Specification
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... -
Page 47: Defibrillator
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... -
Page 48: Battery
Output Patient Phase1 Phase2 Interval Energy Impedan (Amps) (Amps) (ms) (ms) (ms) (Ω) 34.0 17.0 10.9 15.3 11.3 16.3 11.5 19.7 20.5 11.2 19.8 19.8 Pediatric Energy Reducer：Energy Attenuation Factor 50%, at 25 Ω , 25% at 50Ωand 75Ω 20%, at 100Ωand 125Ω 15%, at 150Ωand 175Ω... -
Page 49: Electrodes
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. Electromagnetic environment –... - Page 50 7.6.2 Electromagnetic immunity (IEC 60601-1-2 Table 202) 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. Electromagnetic IEC 60601 test Compliance environment–guidanc...
- Page 51 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 IEC 60601 Complian Electromagnetic environment –...
- Page 52 calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80MHz to 800 MHz 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) and d is the recommended separation distance in meters (m).
- Page 53 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.
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Page 54: Rhythm Recognition Performance
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 Automatic External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance. - Page 55 Meets the AAMI DF39 ＞90% Shockable： VF 1067 requirement and AHA sensitivity recommendation Meets the AAMI DF39 ＞75% requirement and AHA Shockable： VT sensitivity recommendation Meets the AAMI DF39 ＞99% Nonshockabl 4000 sensitivity requirement and AHA e：NSR (AHA) recommendation Meets the AAMI DF39 Nonshockabl ＞95% requirement and AHA...
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Page 56: Glossary
8 Glossary automatic external defibrillator American Heart Association advanced life support arrhythmia irregular rhythm of the heart muscle cardiac arrest cessation of the heart muscle cardiopulmonary resuscitation defibrillation high-energy pulse of electricity (shock) delivered to the heart muscle to restore normal cardiac activity electrocardiogram electrocardiogram... - Page 57 time-stamped event any change in heart rhythm or any shock delivered by the defibrillator...