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M&B AED7000 Plus User Manual

Automatic external defibrillator
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GLCX-06-AED7000 Plus-05
AED7000 Plus Automatic External
Defibrillator
Users Manual
V1.0
Editor:
Approval:
Date:
M&B Part Number AED7000 Plus-101 – Revision 1.0

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Summary of Contents for M&B AED7000 Plus

  • Page 1 GLCX-06-AED7000 Plus-05 AED7000 Plus Automatic External Defibrillator Users Manual V1.0 Editor: Approval: Date: M&B Part Number AED7000 Plus-101 – Revision 1.0...
  • Page 2 GLCX-06-AED7000 Plus-05 AED7000 Plus Automatic External Defibrillator Users Manual V1.0 M&B Part Number AED7000 Plus-101 – Revision 1.0...

  • Page 3: Table Of Contents

    ..................15 EFIBRILLATOR AND LECTRODE 2.5 B ............................17 ATTERY 2.6 C ........................17 ARE AND TORAGE 3 Introducing the AED7000 Plus ............19 3.1 O AED7000 P ......19 VERVIEW OF THE UTOMATIC XTERNAL EFIBRILLATOR 3.2 G AED7000 P ......
  • Page 4 5 Using the AED7000 Plus Automatic External Defibrillator ....................30 5.1 O ........................... 30 VERVIEW 5.2 A ........................30 SSESS THE PATIENT 5.3 S AED7000 P .......... 31 TART THE UTOMATIC XTERNAL EFIBRILLATOR 5.4 A ................32 TTACH THE ELECTRODE PADS TO THE PATIENT 5.5 H...
  • Page 5 10.4 B ............................74 ATTERY 10.5 E ..........................74 LECTRODES 10.6 G ................ 75 UIDANCE AND MANUFACTURER S DECLARATION 10.7 R ..................80 HYTHM ECOGNITION ERFORMANCE Glossary ....................82...

  • Page 6: Preface

    AED7000 Plus 1.2 Manufacturer's Responsibility M&B （Beijing M&B Electronic Instruments, Co., Ltd）is responsible for the safety, reliability, and performance of the AED7000 Plus Automatic External Defibrillator, only if the following conditions are met:  Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by M&B.

  • Page 7: User's Responsibility

    1.3 User's Responsibility The AED7000 Plus Automated External Defibrillator is intended for use by personnel who are authorized by a physician/medical director, and who have had training in the use of an AED. The user should be completely knowledgeable of the information contained in the AED7000 Plus Automatic External Defibrillator Users Manual.
  • Page 8 PEOPLE'S REPUBLIC OF CHINA 1.5.1 Declares that the CE-marketed product Product Name: Automatic External Defibrillator Device Type: Model AED7000 Plus Number: See list in manual Accessories: Complies with Council Directive 93/42/EEC (Medical Device Directive) of June 14 1993 class IIb Annex II 1.5.2 Standards...

  • Page 9: Symbols

    EN 60601-2-4:2010 Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators 10993-1 ： Biological evaluation of medical devices - Part 1: 2009/AC2010 Evaluation and testing within a risk management process EN62304： 2006/A1： 2008 Medical device software - Software life-cycle processes Medical electrical equipment -- Part 1-8: General 60601-1-8:2007/AC:2010 requirements for basic safety and essential performance -...
  • Page 10 Manufacturer mark: Beijing M&B Electronic Instruments Co., Ltd. Serial number General warning sign BF and Defibrillation-proof applied parts Date of manufacture MANUFACTURER Do not throw it away European Representative: Shanghai International Holding Corp. GmbH(Europe) Eiffestrasses 80, 20537 Hanburg, Germany Follow instructions for use Outer signs of packing box TEMPERATURE LIMITATION KEEP DRY...
  • Page 11 Fragile CONFORMITE EUROPEENNE Pads symbols CONFORMITE EUROPEENNE DO NOT REUSE KEEP AWAY FROM SUNLIGHT LATEX DO NOT CONTAINS OR PRESENCE FREE OF NATURAL RUBBER LATEX HIGH VOLTAGE TEMPERATURE LIMITATION DO NOT USE IF PACKAGE IS DAMAGED USE BY BATCH CODE...
  • Page 12 CONSULT INSTRUCTIONS FOR USE Weighing less than 25 kg can not be used Do not open the seal unless the Pad is to be used at once The continuous working time can not exceed 24 hours...

  • Page 13: Safety

    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...
  • Page 14 In this manual, notes are displayed as shown in the following example: Note If the AED7000 Plus is used more than once per month, it is recommended that authorized service personnel perform a periodic inspection servicing at least once per year.

  • Page 15: General Cautions And Notices

    MRI device. 2.2.3 Labels Observe all CAUTION and WARNING labels on the equipment and accessories. 2.2.4 Performance The AED7000 Plus may not meet performance specifications if stored, transported or used outside the specified storage or operating environmental range limits.

  • Page 16: Patient Safety

    2.2.5 Notices If the battery pack is removed for any reason, the user must label the AED7000 Plus as "Out of service due to battery operation." Do not use mobile phones near the AED7000 Plus as the radiation field produced by mobile phones will interfere with the functioning of the AED7000 Plus.
  • Page 17 AED 7000 Pediatric Energy Reducer. Patient Physical Harm Caution Place the AED7000 Plus in a position where it cannot harm the patient should it fall. Do not use adjacent to or stacked with other equipment. Keep all cables and connectors away from the patient's neck.
  • Page 18 Do not use alcohol, iodine or other skin preparations. These can dry the skin and may cause the AED7000 Plus to function improperly or may cause skin burns. Defibrillator electrodes shall be kept well clear of other electrodes or metal parts in contact with the patient.
  • Page 19 Manual. Warning Cardiac pacemakers may affect rhythm analysis Patient pacemakers may reduce the sensitivity of the AED7000 Plus analysis and errors in detecting shockable rhythms. Warning Radio frequency (RF) interference Do not operate the AED7000 Plus in conjunction with electro-cautery or diathermy...

  • Page 20: Defibrillator And Electrode Pads

    2.4.2 Electrical Shock or Fire Hazard Warning No internal, operator-serviceable parts Do not open unit, remove covers or attempt to repair the AED7000 Plus. All servicing must be performed by qualified personnel. Warning Improper use can cause injury The AED7000 Plus contains an automatic disarm of the stored energy.
  • Page 21 Caution Do not immerse or expose the AED7000 Plus to 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...

  • Page 22: Battery

    Caution Use only M&B batteries Use only M&B Part No. CR123A-5x 2 non-rechargeable lithium batteries. Use of any other battery can damage the AED7000 Plus. Caution Always verify remaining capacity of a non-rechargeable battery after use Check capacity and change if battery is low.
  • Page 23 Do not clean the AED7000 Plus with alcohol, ketone, or any flammable agent. Do not autoclave the AED7000 Plus or attempt to sterilize the AED7000 Plus or any of its accessories. 2.6.2 Electrodes Warning Follow manufacturer's instructions for use of defibrillation electrodes...

  • Page 24: Introducing The Aed7000 Plus

    AED7000 Plus ready for use and preparing the unit for storage. 3.1 Overview of the AED7000 Plus Automatic External Defibrillator 3.1.1 Intended use The AED7000 plus Automatic External Defibrillator is a safe, easy to use defibrillation device. The unit is lightweight and mobile and can be used in...
  • Page 25 2 minutes, after which the unit automatically initiates a new ECG analysis. Indications Prior to using the AED7000 Plus, the patient should be assessed by a trained person. If defibrillation with the AED7000 Plus is indicated, all of the following signs should be present during patient assessment: •...
  • Page 26  3.5 inch LCD display 3.1.3 Qualified Operators The AED7000 Plus 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.

  • Page 27: Getting The Aed7000 Plus Automatic External Defibrillator Ready

    3.2.1 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 Plus from the carton and inspect it carefully. Before proceeding: 1.

  • Page 28: Getting To Know The Aed7000 Plus Automatic External Defibrillator

    3． Plug the battery connector to the 3Pins. 4． Put in the battery ;and set up the battery cover . 3.2.3 Running a Self-Test After installing the battery, the AED7000 Plus 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.

  • Page 29: User Interface

     Voice Prompts Detailed information on using, and maintaining the AED7000 Plus are presented in Chapters 5and 6, respectively. 3.4 User Interface 3.4.1 The Front Panel Num. Feature Self test LCD indicator Function key Shock button Shock LED indicator Speaker...
  • Page 30 Patient cable connector 3.4.2 Controls The AED7000 Plus is designed for ease of operation. After putting the defibrillator pads on the patient and connecting them to the AED7000 Plus, the operator performs this simple three-step process: 1. Turn the power ON.
  • Page 31 3.4.4 Voice Prompts The AED7000 Plus prompt feature provides instructional prompts to guide the user through the defibrillation process. The AED7000 Plus provides audio instructions through the built-in speaker to provide operating instruction and assist the user during defibrillation.

  • Page 32: Aed7000 Plus Automatic External Defibrillator Accessories Part List

    3.5 AED7000 Plus Automatic External Defibrillator Accessories Part List 3.5.1 AED7000 Plus Automatic External Defibrillator AED7000 Plus Automatic External Defibrillator AED7000 with one set of defibrillation pads, battery and Plus-001 user manual. 3.5.2 AED7000 Plus Automatic External Defibrillator...

  • Page 33: Self-Test Function Introduction

    4.1 Self test LCD indicator signal introduce 4.2 Introduction of AED self-test function Daily-test: The built-in battery will be tested automatically each Monthly-Test: The AED7000 Plus will perform a full self-test each month or following each battery change. The full self-test includes: battery test, charging &...

  • Page 34: Actions Required During Aed Self-Testing

    LED indicator turns off. And the test result will appear in LCD a. If there is a fault with the AED7000 Plus the following icon will appear: b. If the AED7000 Plus is in optimal working order the following icon will appear: 4.4 Actions required during AED Self-testing...

  • Page 35: Defibrillator

    An emergency cancellation 5.2 Assess the patient Before using the AED7000 Plus, the operator must first check the condition of the patient. The AED7000 Plus can be used on a patient, only if all the following conditions are present: 1. Unconsciousness 2.

  • Page 36: Start The Aed7000 Plus Automatic External Defibrillator

    Pressing the ON/OFF button for 2~3seconds to start the AED7000 Plus, the power indicator will turn on. If the indicator is flickering, it means that the AED7000 Plus is in the status of low power, and the current battery should be replaced.

  • Page 37: Attach The Electrode Pads To The Patient

    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. Before placing the pads, the following procedures must be executed: Remove all clothing covering the chest of the patient Wipe off any water or perspiration on the chest.

  • Page 38: Heart Rhythm Analyzing

    “Check Pad” will stop flickering while “Caution Indicator” and “Analyzing Indicator” will begin flickering. The AED7000 Plus 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.

  • Page 39: Charging Procedure

    There are two possible analysis results. If defibrillation is advised, the AED7000 Plus will start the charging procedure; otherwise, a recommendation of Cardiopulmonary resuscitation procedure (CPR) will begin. 5.6 Charging procedure If the AED7000 Plus determines that the patient requires defibrillation, the charging procedure will start.

  • Page 40: Discharging Procedure

    Energy Energy 2minCPR 2minCPR Level Level Level 2minCPR The AED7000 Plus has three energy of defibrillation(default set )， as shown in the table below: First energy level 150 J Second energy level 150 J Third energy level 200 J Note The charging time depends on the energy of defibrillation.
  • Page 41 Shock cancelled, check the electrodes. If the operator does not press the shock button, the AED7000 Plus will automatically begin internal discharging procedure in 30...

  • Page 42: Cardiopulmonary Resuscitation Procedure (Cpr)

    Pad, Caution, Analyzing and Shock will not flicker. No shockable heart rhythm is detected During the heart rhythm analysis period, if the heart rhythm is not considered to be a shockable rhythm by the AED7000 Plus, a cardiopulmonary resuscitation procedure (CPR) will start. No shock advised...

  • Page 43: An Emergency Cancellation

    Four Cycles At the end of 10 seconds of CPR, the AED7000 Plus will give a prompt to indicate that the operator must stop CPR and not touch the patient so that the AED7000 Plus can restart a heart rhythm analysis and determine if a shockable rhythm condition exists.
  • Page 44 If an unpredictable situation occurs, the operator should press the ON/OFF button for 2 seconds to shut down the AED7000 Plus and internally discharge all the power to the machine...

  • Page 45: Maintaining The Automatic External Defibrillator

    The frequency of inspection: It is recommended that the AED7000 Plus is inspected once a week or twice a month, but if use of the AED7000 Plus is more frequent, additional inspections should be performed. The table below describes a general rule to perform the...
  • Page 46 6.1.2 Check the battery The AED7000 Plus 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.

  • Page 47: Cleaning And Disinfecting

    The followings are the guidelines of cleaning and disinfecting of the AED7000 Plus: 6.2.1 Cleaning Before cleaning the AED7000 Plus, making sure that the AED7000 Plus has been power off, because any cleaning with the machine powered on may cause a shock hazard to the cleaners.
  • Page 48 AED7000 Plus unit when cleaning the machine, as these liquids may cause damage to the AED7000 Plus or a shock hazard. Use a soft cloth to wipe the AED7000 Plus. Never clean the AED7000 Plus with any type of brush. Caution When cleaning the electrode pads socket of the AED7000 Plus, do not use excess water or cleanser.

  • Page 49: Troubleshooting

    6.3 Troubleshooting As with any equipment, problems may occur during the operation of the AED7000 Plus. 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.
  • Page 50 AED7000 Plus, 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 Plus and check the pads...
  • Page 51 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 Plus, the ON/OFF indicator is flickering.
  • Page 52 Solution: Shut down the AED7000 Plus and replace the current battery with a new one.

  • Page 53: Software Operation

    Software operation 7.1 AED7000Plus start menu After AED7000Plus starts, the start menu is displayed as this figure below: A: Defibrillation counter B: date save status icon C: Pressure sensor icon D: Heart rate Date and time Battery G: System configuration menu...
  • Page 54 H: Pressure sensor intensity bar User mode System status K: Pad status Filter status M: Ecg waveform area Defibrillation counter Defibrillation counter presents the number of the released defibrillating, the counter number automatically increases by 1 after every successful defibrillating, otherwise the counter number remains the original value.
  • Page 55 ： The SD card is full ,can’t save new data . ： The process of saving ECG/Sound /Event data is failure . Because the data of data storage feature(ecg, audio, event)is saved as files in the SD card, if some error occurs in the SD card, the data storage feature will be unavailable.
  • Page 56 threshold of the battery voltage can be changed by the following sequence: System configuration menu->Battery->Alarm setting... System configruation menu Config Battery About The software and hardware versions and some other information are shown here. Pressure sensor intensity bar After the pressure sensor module is completely connected with AED, pressure sensor intersity bar begins to display the force intensity placed on the patient.
  • Page 57 Two user mode can be selected: adult and child The selection of the user mode is automatically determined by the plug of the PAD System status The status of the device in different running stage are shown below: stage display Device and the patient are not connected by Wait the pad cable or in unproper connection...

  • Page 58: Configure Aed7000Plus

    Pad error Some pad error occurs Filter status Presents the status of the filters: disable or enable If filter enabled, the icon of corresponding filter is green, otherwise, it turns red. Filters can be configured by the following sequence: System configuration menu->ECG->Filter setting...
  • Page 59 8.1.1 Date and time In the “Config” dropdown list, pressing the + or – key to choose the “Date and time setting...”option, then pressing the ok key to open the “Date and time setting...”dialog. Pressing the ok key moves the curor to the next parameter of “Date and time”, pressing the + or –...
  • Page 60 Pressing the ok key to open the“Volume setting...”dialog. Pressing the + or – key to regulate the value of volume, after finishing regulating, pressing the return key to close the dialog to make the new volume value active. The range of volume value is from 0 to 99, the bigger volume value, the higher sound output.

  • Page 61: Ecg Configuration

    Pressing the ok key to open the“Language setting...”dialog. In the“Language setting...”dialog, pressing the ok key will unfold the language dropdown list, pressing the + or – key to choose a new language, then pressing the ok or return key to fold the language dropdown list. In this case, pressing the return key again will close the“Language setting...”dialog and save the new language.
  • Page 62 8.2.1 Speed setting... The ECG wavform displaying speed can be regulated in this option. In the“ECG” dropdown list, pressing the + or – key to choose the“Speed setting...”option,then pressing the ok key to open the“Speed”dialog. Pressing the ok key will unfold the“Speed”dropdown list. then pressing the + or – key to choose a new speed value.
  • Page 63 In the “ECG”dropdown list, pressing the + or – key to choose the “Gain setting...”option. Pressing the ok key to open the “Gain setting...”dialog. Pressing the ok key to unfold the“Gain”dropdown list. then pressing the + or – key to choose a new gain value. After confirmed, pressing the ok or return key to fold the “Gain”dropdown list and save the new waveform gain value.
  • Page 64 Pressing the ok key to open “Filter setting...”dialog. Step1: Pressing the + or – key to choose a filter, then pressing the ok key to unfold the chosen filter dropdown list. Step2: In the unfolded first dropdown list, pressing the + or – key to choose a new value of the filter, then pressing the ok or return key to fold the filter dropdown list and save the new filter value.

  • Page 65: Battery

    Myoelectric signal filter removes the Myoelectric signal from 25hz to 45hz. Low pass filter removes the high frequency signals above 100hz. 8.3 Battery Pressing the + or – key to move the cursor to the “Battery”option of the“System configuration menu”, then pressing the ok key to open the“Battery”dropdown list. 8.3.1 Alarm setting...

  • Page 66: Guiding Audio For The Operators

    Pressing the ok key to unfold the threshold dropdown list, then pressing the + or – key to choose a new value of alarm threshold. After confirmed, pressing the ok or return key to fold the alarm threshold dropdown list and save the new alarm threshold value. The new alarm threshold value will be active after the next system reset.
  • Page 67 Pad short Analyzing starts，do not touch the patient Charging starts，do not touch the patient No shock is advised Analyzing is canceled Charging is canceled Charging failed Time out Press the shock button Waiting is canceled Begin CPR Shock is canceled...
  • Page 68 Tick...（the guilding audio in the CPR procedure ） 90 seconds left for CPR 60 seconds left for CPR 30 seconds left for CPR Stop CPR, analzying will restart in ten seconds. CPR is canceled Pad error Details Pad open This audio may be brought out in these cases below: Case 1: The two pads are not connected with the patient Case 2: The two pads are connected wiht the patient, but not tightly placed on the skin.
  • Page 69 Pad short This audio may be brought out when the two pads of AED7000Plus are directly connected with each other or some conducting liquid such as the sweat exists on the skin surface of the patient, if these cases occurs, try to clean the sweat, then tightly place the pads on skin surface.
  • Page 70 Charging is canceled The system will broadcast this audio if some unusual condition occurs in the charging module, and release the energy in charging capacity then reenter the ECG analyzing procedure. Charging failed The system will broadcast this audio if the charging module can not load the expected energy into the charging capacity, in such a case, the system releases the energy in charging capacity then reenter the ECG analyzing procedure.
  • Page 71 system will broadcast this audio to the operator, and internally release the energy in the charging capacity, then reenter the “ECG analyzing”procedure. Begin CPR On hearing this audio, the operator must implement the cardiopulmonary resuscitation on the patient immediately Shock is canceled If some undefined situation occurs in the “discharging”...

  • Page 72: Specification

    Stop CPR, the ECG analzying will restart in ten seconds. On hearing this, the operator must stop CPR immediately, and wait for the restart of the ECG analyzing. CPR is canceled If some undefined situation emerges during the CPR procedure, the system will broadcast this audio and quit the CPR procedure, then reenter the ECG analyzing procedure.

  • Page 73: Device

    10.1 Device Category Specification Size (H x W x D) 225 x 200 x 85mm 2.0 kg Weight Unit operates on internal battery only Power Device Classification Class II and internally powered per EN60601-1 Design Standards Meets applicable requirements of IEC 60601-1, IEC 601-2-4, EN 60601-1, IEC 60601-1-2 10.2 Environment Category...

  • Page 74: Defibrillator

    Note 2: Protected against splashing water. Water splashed against the enclosure from any direction shall have no harmful effects Transient operating -4°F to 122° F; -20°C to 50° C conditions: temperature Transient operating 15% to 95% relative humidity, conditions: humidity the time required for the <6 hour EQUIPMENT...
  • Page 75 Output Biphasic Truncated exponential Energy Sequence(adult ) 150/150/200(Default) 150/200/200 200/200/200 Note: the Energy sequence can be changed using the computer IR port. Energy Sequence(Pediatric) 50/70/85(Default) 70/70/85 70/85/85 85/85/85 Note: the Energy sequence can be changed using the computer IR port. Charge Time 10 sec.
  • Page 76 USE, when the device indicate the the device still can support at least 15 times of 150J shock. low battery information...
  • Page 77 Waveform details The table below provides details of the biphasic truncated exponential waveform delivered by the AED7000 Plus (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.

  • Page 78: Pediatric Energy

    Pediatric Energy： Eselect:50J phase1 Interval phase2 R(ohm) E(J) V1(V) V2(V) (ms) (ms) (ms) 49.5 49.4 49.1 49.9 49.2 49.0 49.8 Eselect:70J phase1 Interval phase2 R(ohm) E(J) V1(V) V2(V) (ms) (ms) (ms) 68.5 69.5 69.3 68.4 68.6 1003 69.3 1055 68.8 1105 Eselect:85J phase1...

  • Page 79: Battery

    10.4 Battery Category Specification Part No CR123A-5x2 Non-rechargeable 15V d.c. 2.8Ah Capacity 100 discharges at 200 Joules or 120 discharges at 150 Joules Shelf Life (25 ±15 ) 5 years Note Battery capacity measured according to IEC 60601-2-4, clause 102.3.2 at room temperature. Capacity may be diminished at operating temperature extremes, or when the available battery charge is used in multiple power ON/OFF cycles.

  • Page 80: Guidance And Manufacturer's Declaration

    10.6.1 Electromagnetic emissions (IEC 60601-1-2 Table 201) The AED7000 Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the AED7000 Plus should assure that it is used in such an environment. Electromagnetic environment – Emissions test...
  • Page 81 AED7000 Plus should ensure that it is used in such an environment. Electromagnetic IEC 60601 test Compliance environment–guidan Immunity test level level Electrostatic ±6kV contact ±6kV contact Floors should be discharge (ESD) wood, concrete or ±8kV air ceramic tile. If floors IEC 61000-4-2 ±8kV air...
  • Page 82 10.6.3 Electromagnetic immunity (IEC 60601-1-2 Table 203) The AED7000 Plus is intended for use in the electromagnetic environment specified below. The customer or the user of the AED7000 Plus should ensure that it is used in such an environment. Immunit Complia Electromagnetic environment –...
  • Page 83     80MHz to 800 MHz       800 MHz to 2.5   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 84 If the measured field strength in the location in which the AED7000 Plus 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.

  • Page 85: Rhythm Recognition Performance

    Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 10.7 Rhythm Recognition Performance The AED7000 Plus 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 86 Test Sample Performance Rhythms Conclusion Size Goal Meets the AAMI DF39 ＞90% Shockable： 1067 requirement and AHA sensitivity recommendation Meets the AAMI DF39 ＞75% Shockable： requirement and AHA sensitivity recommendation ＞99% Meets the AAMI DF39 Nonshockable 4000 sensitivity requirement and AHA ：NSR recommendation (AHA)

  • Page 87: Glossary

    11 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 88 time-stamped event any change in heart rhythm or any shock delivered by the defibrillator...

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