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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

Summary of Contents for 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: ...E 17 3 Introducing the AED7000 Plus 19 3 1 OVERVIEW OF THE AED7000 PLUS AUTOMATIC EXTERNAL DEFIBRILLATOR 19 3 2 GETTING THE AED7000 PLUS AUTOMATIC EXTERNAL DEFIBRILLATOR READY 22 3 3 GETTING TO KNOW T...

Page 4: ...8 CARDIOPULMONARY RESUSCITATION PROCEDURE CPR 37 5 9 AN EMERGENCY CANCELLATION 38 6 Maintaining the Automatic External Defibrillator 40 6 1 MAINTENANCE 40 6 2 CLEANING AND DISINFECTING 42 6 3 TROUBLE...

Page 5: ...10 4BATTERY 74 10 5ELECTRODES 74 10 6GUIDANCE AND MANUFACTURER S DECLARATION 75 10 7RHYTHM RECOGNITION PERFORMANCE 80 11 Glossary 82...

Page 6: ...oduct Name Automatic External Defibrillator Device Type AED7000 Plus 1 2 Manufacturer s Responsibility M B Beijing M B Electronic Instruments Co Ltd is responsible for the safety reliability and perfo...

Page 7: ...re 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 Plus and accessor...

Page 8: ...s 2 EN ISO14971 2012 Medical devices Application of risk management to medical devices 3 EN 980 2008 Symbols for use in the labelling of medical devices 4 EN1041 2008 Medical devices Information suppl...

Page 9: ...sic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 12 IEC 60601 1 12 2014...

Page 10: ...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 Ger...

Page 11: ...ENNE Pads symbols CONFORMITE EUROPEENNE DO NOT REUSE KEEP AWAY FROM SUNLIGHT LATEX FREE DO NOT CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX HIGH VOLTAGE TEMPERATURE LIMITATION DO NOT USE IF PACKAGE IS...

Page 12: ...7 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: ...s 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 co...

Page 14: ...uthorized service personnel perform a periodic inspection servicing at least once per year 2 1 4 Voice prompts The AED7000 Plus provides audio instructions through the built in speaker to provide oper...

Page 15: ...ated by magnetic resonance imaging MRI equipment The large magnetic fields generated by an MRI device could move ferromagnetic equipment with an extremely violent force that could cause serious person...

Page 16: ...er equipment and that if adjacent to or stacked use is necessary the AED7000 Plus should be observed to verify normal operation in the configuration in which it will be used 2 2 6 Attention Electric a...

Page 17: ...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 whic...

Page 18: ...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 2 3...

Page 19: ...placed pads may produce incorrect analysis and an inappropriate shock or no shock advisory decision Warning Do not move patient Handling or transporting the patient during ECG analysis can cause inco...

Page 20: ...r 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 Imprope...

Page 21: ...ith alcohol or solvents Do not perform chest compressions CPR through electrodes These actions may damage the electrode pads and cause the unit to function improperly Warning Use only M B approved acc...

Page 22: ...capacity of a non rechargeable battery after use Check capacity and change if battery is low Caution Replace battery at 5 years Battery replacement at 5 years is recommended due to degradation of the...

Page 23: ...ired dry electrodes Do not reuse disposable electrodes Only use M B approved electrodes Caution Properly store and use defibrillation pads Store electrodes in a cool dry location between 60 and 95 F o...

Page 24: ...nt and may affect the normal use of equipment again 3 Introducing the AED7000 Plus This chapter provides an introduction to the AED7000 Plus system and presents an overview of the AED7000 Plus control...

Page 25: ...electrocardiographic ECG rhythm of the victim s heart analyzes that rhythm and determines whether the rhythm is shockable or non shockable When needed defibrillation energy is delivered through these...

Page 26: ...prompts for the operator biphasic energy output 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 f...

Page 27: ...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 Open an...

Page 28: ...main processor memory and program ECG acquisition system and defibrillator 3 3 Getting to Know the AED7000 Plus Automatic External Defibrillator The AED7000 Plus is an automatic external defibrillati...

Page 29: ...taining the AED7000 Plus are presented in Chapters 5and 6 respectively 3 4 User Interface 3 4 1 The Front Panel Num Feature 1 Self test LCD indicator 2 Function key 3 MIC 4 Shock button 5 Shock LED in...

Page 30: ...n 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 charged 3 4 3 LCD Prompts Operating information an...

Page 31: ...the electrodes 3 Shock delivered 4 Time out analysis restart 5 Analyzing do not touch the patient 6 Charging do not touch the patient 7 No shock advised 8 Press flashing shock button 9 Stop CPR start...

Page 32: ...l Defibrillator with one set of defibrillation pads battery and user manual 3 5 2 AED7000 Plus Automatic External Defibrillator Accessories Type Description CR123A 5x2 M B Battery Pack Non rechargeabl...

Page 33: ...est each month or following each battery change The full self test includes battery test charging discharging test data collection and data communication test 4 3 Self test function description in det...

Page 34: ...following icon will appear 4 4 Actions required during AED Self testing 1 The AED7000 Plus will only function under normal operating condition if the following icon is shown 2 Monthly test when Batte...

Page 35: ...the AED7000 Plus Attach the electrode pads to the patient Heart rhythm analyzing Charging procedure Discharging procedure Cardiopulmonary resuscitation procedure CPR An emergency cancellation 5 2 Ass...

Page 36: ...and the current battery should be replaced 5 3 2 Check the working condition After the AED7000 Plus starts the AED7000 Plus will begin to check the condition of the pads connection Before the pads ar...

Page 37: ...ring the chest of the patient 2 Wipe off any water or perspiration on the chest Following these two steps the pads can be placed on the patient Place the pads on the patient Open the package of the el...

Page 38: ...at the same time a voice prompt will broadcast to indicate the next steps to the operator Analyzing do not touch the patient Note If the electrodes are properly connected the indicator of Check Pad wi...

Page 39: ...AED7000 Plus determines that the patient requires defibrillation the charging procedure will start Note During the charging procedure Caution indicator and analyzing indicator will be flickering Charg...

Page 40: ...ird energy level 200 J Note The charging time depends on the energy of defibrillation 5 7 Discharging Procedure When the charging procedure of the AED7000 Plus has finished the AED7000 Plus will enter...

Page 41: ...n is flashing which means the AED7000 Plus is properly charged Before pressing the shock button make sure no one is touching the body of the patient Press the shock button Note If the shock button is...

Page 42: ...f 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 During the period of charging if the AED7000...

Page 43: ...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 rhyt...

Page 44: ...39 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: ...commended 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...

Page 46: ...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 WARNING If the condition...

Page 47: ...BRILLATOR 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 6 2 Cl...

Page 48: ...iquids 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 soc...

Page 49: ...The voice prompt of Check the electrode continues to broadcast when the electrode pads have been placed on the patient and the pads connector has been connect to the socket of the AED7000 Plus Soluti...

Page 50: ...mly on the chest of the patient then start the AED7000 Plus again b If the patient has moved during the analyzing period shut down the AED7000 Plus and immobilize the patient if possible 6 3 3 Trouble...

Page 51: ...ion following completion of the analysis process The unit broadcasts a voice prompt of Time out analysis restart Time out analysis restart Solution If the operator doesn t press the shock button in 30...

Page 52: ...47 Solution Shut down the AED7000 Plus and replace the current battery with a new one...

Page 53: ...000Plus 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 E Date and time F Batt...

Page 54: ...ful defibrillating otherwise the counter number remains the original value A successuful defibrillation includes all the complete stages from charging to discharging B SD card icon Data save status ic...

Page 55: ...r and AED7000Plus Normal Unconnected or some error occurs in the pressure sensor D Heart rate Presents heart rate value The maximum heart rate is 360 per minute E Date and time Presents the date and t...

Page 56: ...System configruation menu Config ECG Battery About The software and hardware versions and some other information are shown here H Pressure sensor intensity bar After the pressure sensor module is comp...

Page 57: ...r in unproper connection Wait Device and the patient are connected by the pad cable properly Analyzing Charging in progress The charging energy value Discharging is ready Ready Discharging completed S...

Page 58: ...s green otherwise it turns red Filters can be configured by the following sequence System configuration menu ECG Filter setting M ECG waveform area 8 Configure AED7000Plus 8 1 System function configur...

Page 59: ...me setting dialog Pressing the ok key moves the curor to the next parameter of Date and time pressing the or key will regulate the value of the selected parameter after all changes are done pressing t...

Page 60: ...olume 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 outp...

Page 61: ...ing 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 The new selected language will b...

Page 62: ...tting 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 After confirmed pressing the...

Page 63: ...g 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...

Page 64: ...t 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 Filter setting has three filte...

Page 65: ...he 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 This option is to determine the alarm threshold in the c...

Page 66: ...g 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 9 Guiding audio for the...

Page 67: ...touch the patient 4 Charging starts do not touch the patient 5 No shock is advised 6 Analyzing is canceled 7 Charging is canceled 8 Charging failed 9 Time out 10 Press the shock button 11 Waiting is c...

Page 68: ...tart in ten seconds 19 CPR is canceled 20 Pad error Details 1 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...

Page 69: ...uch the patient in order to reduce the uncorrect result caused by the external interference 4 Charging starts do not touch the patient On hearing this audio means the charging module has been active t...

Page 70: ...nters the waiting for discharging procedure the system will be blocked and wait for the operator to press the shock button to externally release the energy to the patient but this audio will be broadc...

Page 71: ...n the discharging procedure the system will broadcast this audio and stop discharging and internally release the rest of energy in the charging capacity 14 Tick the guilding audio in the CPR procedure...

Page 72: ...n reenter the ECG analyzing procedure 20 Pad error When some undefined situation occurring in the pad impedance calculation module leads to a incorrect impedance value the system will broadcast this a...

Page 73: ...nditions 40 C to 5 C without relative humidity control 5 C to 35 C at a relative humidity up to 90 non condensing 35 C to 70 C at a water vapour pressure up to 50 hPa Operating Temperature 32 F to 122...

Page 74: ...tive humidity the time required for the ME EQUIPMENT to warm from the minimum storage temperature between uses 4 2 1 until the ME EQUIPMENT is ready for its INTENDED USE when the ambient temperature i...

Page 75: ...readiness for maximum Energy discharge after 15 shocks Less than 30 seconds The maximum time from initially switching power on to readiness for maximum Energy discharge after 15 shocks Less than 35se...

Page 76: ...71 USE when the device indicate the low battery information the device still can support at least 15 times of 150J shock...

Page 77: ...tput phase Values are within 10 Eselect 150J R ohm E J V1 V phase1 ms interval phase2 ms V2 V 25 139 2 1121 9 0 4 6 212 50 144 5 1209 9 0 4 6 508 75 146 6 1289 9 0 4 6 717 100 148 2 1374 9 0 4 6 882 1...

Page 78: ...R ohm E J V1 V phase1 ms Interval ms phase2 ms V2 V 25 68 5 842 9 0 4 6 139 50 69 5 862 9 0 4 6 350 75 69 3 903 9 0 4 6 496 100 68 4 952 9 0 4 6 607 125 68 6 1003 9 0 4 6 700 150 69 3 1055 9 0 4 6 78...

Page 79: ...C 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 10 5Electrodes...

Page 80: ...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 No...

Page 81: ...ative 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 Not applicable Surge IEC 61000 4 5 1kV differe...

Page 82: ...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 y test IEC 60601 test level Complia nce le...

Page 83: ...cientific 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 frequen...

Page 84: ...and mobile RF communications equipment and the AED7000 Plus IEC 60601 1 2 Table 205 The AED7000 Plus is intended for use in an environment in which radiated RF disturbances are controlled The customer...

Page 85: ...mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation...

Page 86: ...ensitivity 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 sensitivi...

Page 87: ...id twitching movements that replace the normal rhythmic contraction of the heart and may cause a lack of circulation and pulse Joule The amount of energy delivered during defibrillation related to the...

Page 88: ...83 time stamped event any change in heart rhythm or any shock delivered by the defibrillator...

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