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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.

Содержание AED7000

Страница 1: ...GLCX 06 AED7000 05 AED7000 Automatic External Defibrillator Users Manual V2 7 M B Part Number AED7000 101 Revision 2 7...

Страница 2: ...STORAGE 14 2 7 SAFETY SYMBOLS 15 3 Introducing the AED7000 17 3 1 OVERVIEW OF THE AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR 17 3 2 GETTING THE AED7000 AUTOMATIC EXTERNAL DEFIBRILLATOR READY 19 3 3 GET...

Страница 3: ...5 7 DISCHARGING PROCEDURE 31 5 8 CARDIOPULMONARY RESUSCITATION PROCEDURE CPR 32 5 9 AN EMERGENCY CANCELLATION 34 6 Maintaining the Automatic External Defibrillator 35 6 1 MAINTENANCE 35 6 2 CLEANING...

Страница 4: ...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 perform...

Страница 5: ...d 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 servi...

Страница 6: ...tive 93 42 EEC Medical Device Directive of June 14 1993 class IIb Annex II 1 5 2 Standards General ISO13485 2003 ISO14155 2003 ISO14971 2007 EN980 2008 EN1041 1998 Safety IEC60601 1 1988 A1 1991 A2 19...

Страница 7: ...4 CE Mark BF and Defibrillation proof applied parts Change batteries Batteries Caution Serial number Date of manufacture Europe representative...

Страница 8: ...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...

Страница 9: ...uthorized 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...

Страница 10: ...c 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 de...

Страница 11: ...elds can interfere with the equipment s regular work Therefore please ensure all external devices used near the AED7000 comply with EMC demands 2 3 2 3 Patient Safety 2 3 1 General Warning Accessory a...

Страница 12: ...ring defibrillation Disconnect other electrical equipment which has no DEFIBRILLATION PROOF applied parts from the patient before defibrillating Avoid contact between parts of the patient s body such...

Страница 13: ...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 contact with the patient 2 3...

Страница 14: ...ly 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 in...

Страница 15: ...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 Warning Improper use can cause injury The...

Страница 16: ...ns CPR through electrodes These actions may damage the electrode pads and cause the unit to function improperly Warning Use only M B approved accessories Do not use defibrillation pads batteries and o...

Страница 17: ...place battery at 5 years Battery replacement at 5 years is recommended due to degradation of the battery chemistry Periodic maintenance and testing is highly recommended to ensure proper battery perfo...

Страница 18: ...perly 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...

Страница 19: ...ccessories 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 c...

Страница 20: ...nced life support ALS personnel The AED7000 recognizes ventricular fibrillation and other ventricular tachycardia and guides operators through the defibrillation process When properly connected to a p...

Страница 21: ...erator biphasic energy output 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 e...

Страница 22: ...ton 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 an...

Страница 23: ...ses 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 7...

Страница 24: ...ibrillator pads are not properly attached to the patient or are not properly connected to the AED7000 Caution LED Flashes Do not touch or move the patient Analyzing LED Flashes ECG leads are properly...

Страница 25: ...30 chest compressions and 2 mouth to mouth breaths Now give 30 chest compressions Now give 2 mouth to mouth breaths Four Cycles 3 4 4 Battery Level Indicator Power LED is bright Indicates the charge...

Страница 26: ...0 Automatic External Defibrillator Accessories CR123A 4x2 M B Battery Pack Non rechargeable LiMnO2 battery EDC 1035 Set Of Two Multi Function Electrodes AED7000 101 AED7000 Automatic External Defibril...

Страница 27: ...elf 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...

Страница 28: ...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...

Страница 29: ...ceeding 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...

Страница 30: ...g 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 t...

Страница 31: ...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...

Страница 32: ...eart rhythm analyzing Once the pads are placed on the patient correctly the AED7000 will begin to analyze the heart rhythm of the patient at the same time a voice prompt will broadcast to indicate the...

Страница 33: ...6 Charging procedure If the AED7000 determines that the patient requires defibrillation the charging procedure will start Note During the charging procedure Caution indicator and analyzing indicator...

Страница 34: ...l enter the discharging procedure and give voice prompts to the operator Note During the discharging procedure shock indicator Caution indicator and analyzing indicator will be flickering WARNING Duri...

Страница 35: ...flickering of Caution indicator will continue Prior to pressing the shock button if the AED7000 detects that the pads are not firmly placed on the chest of the patient the following alert will occur S...

Страница 36: ...tor can touch the body of the patient and check their conditions Note During the cardiopulmonary resuscitation period the AED7000 will ignore the heart rhythm analyzed result and the improper electrod...

Страница 37: ...y cancellation If any unpredictable situation occurs the operator can use the ON OFF button to make an emergency cancellation Examples of unpredictable situation may include The movement of the patien...

Страница 38: ...ns 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 perf...

Страница 39: ...ce 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 conditi...

Страница 40: ...ntact pins Place the battery into the battery compartment and replace the battery cover Slide the cover back so that the screw holes are aligned Replace the thumbscrews Caution We recommend replacing...

Страница 41: ...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 cleaning with the machine powered on may cause a shoc...

Страница 42: ...n 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 Note The operator could try to...

Страница 43: ...r 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...

Страница 44: ...e 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 pro...

Страница 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 o...

Страница 46: ...cognition performance 7 1 Physical Category Specification Dimensions 303 x 216 x 89 mm Weight 2 0 kg Operating Temperature 0 to 40 Operating Humidity Relative humidity between 30 and 95 non condensing...

Страница 47: ...m start of analysis to shock ready from power up Less than 20 seconds after 6 shocks Less than 25 seconds Audible Prompts 22 audible prompts Visual Prompts LED prompts Controls Two buttons On Off Shoc...

Страница 48: ...7 9 6 0 7 125 9 2 6 8 20 5 11 2 0 7 150 7 6 5 8 19 8 10 0 7 175 6 5 5 2 19 8 10 0 7 Pediatric Energy Reducer Energy Attenuation Factor 50 at 25 25 at 50 and 75 20 at 100 and 125 15 at 150 and 175 7 4...

Страница 49: ...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 specif...

Страница 50: ...ser of the AED7000 should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidanc e Electrostatic discharge ESD IEC 61000...

Страница 51: ...ypical commercial or hospital environment NOTE UT is the AC mains voltage prior to application of the test level 7 6 3 Electromagnetic immunity IEC 60601 1 2 Table 203 The AED7000 is intended for use...

Страница 52: ...ncy range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial s...

Страница 53: ...he 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...

Страница 54: ...ations equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorptio...

Страница 55: ...39 requirement and AHA recommendation Nonshockabl e NSR 4000 99 sensitivity AHA Meets the AAMI DF39 requirement and AHA recommendation Nonshockabl e asystole 179 95 sensitivity Meets the AAMI DF39 req...

Страница 56: ...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...

Страница 57: ...54 time stamped event any change in heart rhythm or any shock delivered by the defibrillator...

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