Mediana hearton aed a10 Operator'S Manual Download

Page: 45 / 49

Item Standard

Description

IEC60601-1-11:2010
EN60601-1-11:2010

Requirements for medical electrical equipment
and medical electrical systems used in the home
healthcare environment

ISO10993-1:2009

EN ISO10993-1:2009
/AC:2010

Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management
process

ISO10993-5:2009

EN ISO10993-5:2009

Biological evaluation of medical devices – Part 5:
Tests for in vitro cytotoxicity

ISO10993-10:2010
EN ISO10993-10:
2010

Biological evaluation of medical devices – Part 10:
Tests for irritation and delayed-type
hypersensitivity

EN 1789:2007 +A1:2010

Medical vehicles and their equipment
– road ambulance

EN13718-1:2008

Medical vehicles and their equipment – Air
ambulances – Part1: Requirements for medical
devices used in air ambulances.

RTCA/ DO-160G

Environmental Conditions and Test Procedures
for Airborne Equipment

Defibrillator

IEC60601-2-4:2002
EN60601-2-4:2003

Safety of cardiac defibrillators

AAMI DF80:2003

Safety of cardiac defibrillators (including
automated external defibrillators)

EMC IEC60601-1-2:2007

EN60601-1-2:2007
/AC:2010

Electromagnetic compatibility-requirements & test

IEC61000-4-2:2008
EN61000-4-2:2009

Electrostatic discharge (ESD) Ed.2.0

IEC61000-4-3:2006
+A1:2007 +A2:2010
EN61000-4-3:2006
+A1:2008 +A2:2010

Radiated RF electromagnetic field Ed.3.1

IEC61000-4-8:2009
EN61000-4-8:2010

Power frequency (50/60Hz) Magnetic field Ed.2.0

CISPR11:2009+A1:2010
EN55011: 2009 +A1:2010

Limits and methods of measurement of radio
disturbance characteristics of industrial scientific
and medical (ISM) radio-frequency equipment
RF emissions, Group 1, Class B

Package

ISTA (Procedure 1A,
2001)

Pre-Shipment test procedures (Package)

ASTM D4169:2009

Standard practice for performance testing of
shipping containers and system

Reliability IEC60068-1:1988

+A1:1992
EN 60068-1:1994

Environmental testing, Part1: General guidelines

IEC60068-2-27:2008,

EN60068-2-27:2009

Environmental testing – Shock

IEC60068-2-6:2007,

EN60068-2-6:2008

Environmental testing – Vibration

IEC60068-2-64:2008,

EN60068-2-64:2008

Environmental testing: vibration, broad-band
random (digital control) and guidance

IEC60068-2-31:2008 Environmental

testing - Part 2-31: Tests - Test Ec:

Summary of Contents for hearton aed a10

Page 1: ...or www medianadefib co uk Distributed by Reliance Medical Limited Congleton Cheshire CW12 4XP Part Number Revision A7300 0 Revised Date 0613 Copyright 2013 All rights reserved OPERATOR S MANUAL HeartOn A10 Automated External Defibrillator MEDIANA HEARTON AED A10 ...

Page 2: ...ed by accidents or natural disasters earthquakes flooding etc Damage resulting from usage where caution statements and operating instructions shown in this manual have not been followed Damage due to neglect of specified maintenance checks This warranty only covers the hardware of the HeartOn A10 The warranty does not cover the following selections Whatever damage or loss results from the attachme...

Page 3: ...attery Status Indication 16 Self Test 17 USING THE AED 19 2010 AHA Guidelines for CPR and ECC 19 Major changes in the 2010 AHA Guidelines for CPR and ECC 19 2010 CPR GUIDELINES 20 Pre Defibrillation Action 20 Operating the AED 21 AHA 2010 configuration 25 Note Performing CPR 25 Note User and Bystander Safety 26 MAINTENANCE 27 Recycling and Disposal 28 Returning the AED and System Components 28 Ser...

Page 4: ...Step 5 23 Figure 10 Pads Placement 23 Figure 11 Action Icon Step 6 23 Figure 12 Action Icon Step 7 24 Figure 13 Action Icon Step 8 24 Figure 14 Use by date of Pads 30 Tables Table 1 Panel and Label Symbols 9 Table 2 Accessories 11 Table 3 The battery Status Icon 16 Table 4 Electromagnetic Emissions IEC60601 1 2 43 Table 5 Electromagnetic Immunity IEC60601 1 2 43 Table 6 Electromagnetic Immunity IE...

Page 5: ... Caution must be taken to ensure that neither the operators nor bystanders touch the when a shock is to be delivered WARNING To safeguard against interference you must operate the AED at 2 meters 6 feet away from all RF devices and other susceptible equipment Alternatively switch off equipment affected by or causing Electromagnetic Interference WARNING The AED has been designed to work on unrespon...

Page 6: ...tact with the patient WARNING Avoid contact between parts of patient s body and conductive fluids such as gel blood or saline and metal objects which may provide unwanted pathways for defibrillating current WARNING Do not use the AED near or within puddles of water WARNING Do not reuse electrodes to many patients WARNING Use the AED or accessories only as described in this manual Improper use of t...

Page 7: ...r place the AED in service until you have read the AED Operator s manual CAUTION Do not use or stack the AED with other equipment If the AED is used or stacked with other equipment verify proper operation prior to use CAUTION Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis CAUTION Periodic checks of this AED must be undertaken to ensure among other...

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Page 9: ...y includes areas such as general care floors operating rooms special procedure areas intensive and critical care areas within the hospital Hospital type facilities include physician office based facilities sleep labs skilled nursing facilities surgical centers and sub acute care centers Note The intended patient populations are adult and pediatric 1 8 years old or less than 25 kg 55lb can be treat...

Page 10: ...ana dealer or Mediana directly either of whom can arrange for training to be provided Alternatively contact your local government health department for information on certified training organizations in your region Note There is limited published data on AED used by minimally trained rescuers in the home It is not clear what safety issues may occur from AED use in such an environment Features for ...

Page 11: ...onnector links the pads 4 LED indicator LED indicator flashes red LED under the relevant action icon 5 Power on off button Power on off button turns on off the AED 6 Speaker Speaker is acoustic indicator for guidance 7 Push button Push button opens the cover 8 Shock button Shock button delivers the shock 9 SD card port SD card is used to save the data and update the AED firmware 10 Infrared commun...

Page 12: ...8 Bottom Panel Components 1 Battery pack Figure 2 Bottom Panel Components Rear Panel Components 1 Handle Figure 3 Rear Panel Components 1 1 ...

Page 13: ... capacity Follow instructions for use Contains no latex Environmental shipping storage altitude limitations Use by date Environmental shipping storage humidity limitations EU representative Environmental shipping storage temperature limitations Manufacturer Fragile handle with care Date of manufacture This way up Reference number Keep dry Serial number Type CF Defibrillator proof Single patient us...

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Page 15: ... to ensure integrity of seals and validity of use by date List of Components The following items are accessories in the package Optional accessories may be ordered if needed Contact qualified service personnel or your local supplier for pricing and ordering information Table 2 Accessories Standard Accessories Qty HeartOn A10 1 Operator s manual 1 Adult Pads 1 7m 1 Non rechargeable LiMnO2 Battery 1...

Page 16: ... firmware The recorded history in the SD card can be checked by the HeartOn A10 Event Review Software If you want to use the SD card to use the HeartOn A10 Event Review Software or to update the AED firmware please contact qualified service personnel or your local supplier 1 When the AED is turned on turn off the AED by pressing the Power on off button 2 Open the SD card port cover 3 Insert the SD...

Page 17: ... pre attached to the AED and keep the pads cable connected to the AED at all times Install 2 Check that the AED is working optimally 1 Push the Power on off button 2 Ensure that you can hear the voice prompts Unit ok Adult pads or Pediatric pads 3 Ensure you can see the status indicator display O 4 Turn off the AED by pushing the Power on off button 5 Close the Cover with placing the defibrillatio...

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Page 19: ...ty of not operating CAUTION If the battery shows any signs of damage leakage or cracking it must be replaced immediately CAUTION Discarded batteries may explode during incineration Dispose used batteries properly Do not dispose of batteries in refuse containers CAUTION Check battery capacity regularly Replace the new battery if you need CAUTION Except for inspection if the AED is frequently turned...

Page 20: ...llation therapies or 10 hours of operating time under the ambient temperature at 20 C Mediana recommends that although the battery is used only one time used battery is changed to new battery Note After 200 times of shock the voice prompt Low battery replace new battery will be emitted Note Due to the physical dimensions of the battery compartment only batteries supplied by Mediana should be used ...

Page 21: ...t Unit ok and status indicator displays O 5 Turn off the AED by pressing the Power on off button Automatic Self Test The AED includes an automatic self test which is performed on a daily basis The self test will run automatically and requires no user interaction If there is an error the status indicator displays X The self test will test your AED and ascertain if its basic functions are running Da...

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Page 23: ... literature ever published the 2010 ILCOR International Consensus on CPR and ECC Science with Treatment Recommendations Bystanders first responders and healthcare providers all play key roles in providing CPR for victims of cardiac arrest In addition advanced providers can provide excellent periarrest and postarrest care Major changes in the 2010 AHA Guidelines for CPR and ECC The BLS algorithm ha...

Page 24: ...for breathing when checking responsiveness to detect signs of cardiac arrest 30 Compressions 2 Breaths UNTIL EMC ARRIVE 30 2 Perform CPR until an AED is available or arrival of emergency physician Note Elimination of 2 ventilations from sequence makes recommendations to continue the chest compressions If the AED available turn on and follow instructions Repeat every 2 minutes ANALYSIS SHOCK DECISI...

Page 25: ...lation pads are to be applied if necessary WARNING Always check the use by date on the pads and do not use the pads if the packaging has been previously opened The AED may interpret excessively dry pads as an attached pads cable WARNING Touching the patient during the analysis phase of treatment can cause interference with the diagnostic process Avoid contact with the patient while analysis is bei...

Page 26: ...eck for response Are you all right Figure 5 Action Icon Step 1 STEP 2 Call for help Figure 6 Action Icon Step 2 STEP 3 Open the airway Figure 7 Action Icon Step 3 STEP 4 Check breathing Figure 8 Action Icon Step 4 ...

Page 27: ...emitted Plug in pads Insert connector firmly Figure 9 Action Icon Step 5 Adult age 8 weight 25kg 55lbs Pediatric age 8 weight 25kg 55lbs Figure 10 Pads Placement WARNING Apply freshly opened and undamaged pads within use by date to clean and dry skin to minimize burning STEP 6 When the pads are attached correctly to the patient you will hear the voice prompts Analyzing heart rhythm Do not touch th...

Page 28: ...ng patient can lead to incorrect delayed or less effective diagnosis and therapy STEP 7 Press the shock button now Deliver shock now Shock delivered or Shock button not pressed Figure 12 Action Icon Step 7 Note The AED will only administer a shock if it is needed A voice prompt will tell you when to press the shock button to administer defibrillation therapy STEP 8 It is safe to touch the patient ...

Page 29: ...rate of 30times of chest compression 2min Or perform the chest compression without rescue breath The AED will remain in CPR mode for 2 minutes or 5 cycles After 2 minutes of CPR you will hear the following voice prompt Stop CPR The AED will then return to Step 6 which is analyzing ECG and repeat this procedure Ensure that no one is in contact with the patient and proceed as before This instruction...

Page 30: ...k button Do not touch the patient while the AED is analyzing or delivering a shock is in process Defibrillation energy can cause injury As long as the AED is used according to the directions and no one is in contact with the patient when the Shock button is pressed there is no risk of harm to the rescuer or bystanders The AED cannot deliver a shock unless the pads are applied to someone whose hear...

Page 31: ...orm the battery by applying pressure Do not throw hit drop fold or impact the battery CAUTION Do not use the battery with other maker s batteries different types or models of batteries such as dry batteries nickel metal hydride batteries or Li ion batteries together as they might leak electrolyte heat or explode CAUTION Do not mistreat the battery or use the battery in applications not recommended...

Page 32: ...e for in the treatment of sudden Recycling and Disposal When the AED battery or accessories reach the end of useful life recycle or dispose of the equipment according to appropriate local and regional regulations Note The AED should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities Note The correct di...

Page 33: ... may need to replace the fresh battery If the battery is not inserted into the AED the battery has a shelf life 2 years from manufacture date For diagnosis of the reason for status indicator display X please refer to the troubleshooting section Pads Maintenance Replacement of the pads must be carried out if The use by date of the pads has been exceeded When the pads have been used it is a single u...

Page 34: ... replacements Figure 14 Use by date of Pads 3 Check AED and accessories for damage or use by date Replace any accessories found to be damaged or that have exceeded their use by date 4 Check the exterior of the AED for cracks or other signs of damage Contact qualified service personnel or your local supplier if any damage is found 5 Check that trained users are aware of the AED location and that it...

Page 35: ...ned on or if for any reason you have suspicions that your AED is not working correctly contact qualified service personnel or your local supplier or Mediana directly for support info mediana co kr 1 There is no response to the Power on off button A CPU module may be malfunctioned Notify qualified service personnel or your local supplier to check and replace the CPU module The battery may be missin...

Page 36: ...and high definition television it is possible that high levels of such interference due to close proximity or strength of a source may affect AED operation WARNING The AED is designed for use in environments in which the signal can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the AED may not seem to operate correctly The AED disruption...

Page 37: ...ignals in the heart is often the cause of SCA but a shock can be administered to re establish sinus rhythm This treatment is called defibrillation The AED is designed to automatically detect ventricular fibrillation VF and perform defibrillation on victims of sudden cardiac arrest Ventricular Tachycardia Ventricular Fibrillation Is a life threatening heart rhythm that is treatable with the therapy...

Page 38: ...tim s heart to return to a normal sinus rhythm HeartOn A10 The AED is a semi automatic device used for the delivery of external defibrillation therapy to resuscitate victims of SCA who are unresponsive are not breathing or without life signs HeartOn A10 Event Review Software HeartOn A10 Event Review Software is software that can be used in conjunction with the AED and SD card or Infrared communica...

Page 39: ... to 175 ohm Heart Rate 20 to 300 per min Accuracy 1 per min Detection V F more than 200 µV V T more than 160 per min Lead off detection Detected and voiced Filter 0 5 to 30 Hz Indication Controls Standard Green Power on off button Red Shock button Indicators Visible ICON LED Indicator Status LCD Audible Audio speaker Voice prompt Beep CPR indication Physical Dimensions 341 259 109 mm W H D Weight ...

Page 40: ...z Acceleration 10 Hz to 100 Hz 5 0 m s Hz 100 Hz to 200 Hz 7 dB per octave 200 Hz to 2000 Hz 1 0 m s Hz Drop height 1m Water and dust resistance IP54 IEC60529 Storage in shipping container Temperature 20 to 60 C 4 to 140 F Relative Humidity 5 to 95 Non condensing Altitude 0 to 12 192 m Self Test Cycle Every 24 hours 1 week 1 month Power on self test Test result Status LCD displays O X Data Backup ...

Page 41: ...on 0 to 43 C 32 to 109 4 F Storage 0 to 43 C 32 to 109 4 F Relative Humidity 5 to 95 Non condensing Battery Battery Type LiMnO2 Disposable Long Life Primary Cell Voltage Capacity 15V 4200 mAh Shelf Life in the original packaging 2 years from manufacture date Standby Life inserted in the AED 5 years from manufacture date Discharge A minimum of 200 shocks excepting the CPR period between the defibri...

Page 42: ...djusted based on delivered charge in order to compensate for patient impedance variations as shown below Adult defibrillation Load Resistance Ω Pulse width 1 ms Pulse width 2 ms Delivered Energy J 25 3 3 3 1 195 50 4 7 4 1 190 75 6 7 4 7 185 100 8 3 5 9 195 125 9 7 6 7 190 150 11 3 7 9 185 175 11 7 8 7 180 Pediatric defibrillation Load Resistance Ω Pulse width 1 ms Pulse width 2 ms Delivered Energ...

Page 43: ...plies with IEC60601 2 4 2002 specificity 95 Database for ECG Analysis From AHA American Heart Association official database From MIT Massachusetts institute Technology official database MIT BIH Arrhythmia Database and Creighton University Ventricular Tachyarrhythmia Database ECG rhythm to determine if a shock is appropriate Ventricular Fibrillation at a amplitude greater than or equal to 0 2mV Ven...

Page 44: ... ISO13485 2012 AC 2012 Quality systems Medical Devices Requirements for regulating purposes ISO14971 2007 EN ISO14971 2012 Application of risk management to Medical devices IEC60601 1 1988 A1 1991 A2 1995 EN60601 1 1996 General requirements for safety of medical electrical equipment IEC60529 1989 A1 1999 EN60529 1991 A1 2000 Degree of Protection Provided by Enclosures Water Ingress Testing IP54 IS...

Page 45: ...brillators including automated external defibrillators EMC IEC60601 1 2 2007 EN60601 1 2 2007 AC 2010 Electromagnetic compatibility requirements test IEC61000 4 2 2008 EN61000 4 2 2009 Electrostatic discharge ESD Ed 2 0 IEC61000 4 3 2006 A1 2007 A2 2010 EN61000 4 3 2006 A1 2008 A2 2010 Radiated RF electromagnetic field Ed 3 1 IEC61000 4 8 2009 EN61000 4 8 2010 Power frequency 50 60Hz Magnetic fiel...

Page 46: ...ith medical device labels labeling and information to be supplied Part 1 General requirements ISO15223 2 2010 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 2 Symbol development selection and validation ISO7000 2012 Graphical symbols for use on equipment index and synopsis EN50419 2006 Marking of electrical and electronic equipment in acc...

Page 47: ...roup 1 The AED must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CISPR 11 Class B The AED is suitable for use in all establishments Table 5 Electromagnetic Immunity IEC60601 1 2 Immunity Test IEC60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV c...

Page 48: ...rvey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths fro...

Page 49: ...00 MHz to 2 5GHz d 2 3 P 0 01 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 8 7 3 100 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 N...

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