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  5. Operator's Manual

Mediana hearton aed a10 Operator's Manual

Manual is about: Automated External Defibrillator

Summary of hearton aed a10

  • Page 1

    Operator’s manual hearton a15 ® automated external defibrillator 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 defi...

  • Page 2

    Directive copyright law allows no part of this instruction manual to be reproduced without permission. The contents of this manual are subject to change without notice. The contents of this manual should be correct. If, for some reason, there are any questionable points, please do not hesitate to co...

  • Page 3: Contents

    I contents contents .................................................................................................................................................... I safety information .................................................................................................................

  • Page 4

    Ii figures figure 1. Top and right panel components ................................................................................................. 7 figure 2. Bottom panel components ............................................................................................................ 8 fig...

  • Page 5: Safety Information

    1 safety information general safety information this section contains important safety information related to general use of the hearton a10 ® . Other important safety information appears throughout the manual. The hearton a10 ® will be referred to as the aed throughout this manual. Before use, care...

  • Page 6

    2 warning: the adult pads must be used on patients over 8 years old. The pediatric pads must be used on patients less than 8 years old or less than 25 kg (55lb). Do not use the aed on patient less than 1 year old. Warning: proper placement of the pads is critical. Strict observance of pad positionin...

  • Page 7

    3 cautions cautions are identified by the caution symbol shown above. Caution statements identify conditions or practices that could result in damage to the equipment or other property. Caution: the aed may not operate properly if it is operated or stored at conditions outside the ranges stated in t...

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    4 this page is intentionally left blank..

  • Page 9: Introduction

    5 introduction mediana provides you with a fully configurable aed system to allow you to comply with your chosen sca treatment protocol. Our current aed is configured to be compliant with the 2010 version of the aha/erc guidelines on cardiopulmonary resuscitation (cpr) and emergency cardiovascular c...

  • Page 10

    6 training sca is a condition requiring immediate emergency medical intervention. This intervention, due to the nature of the condition, can be performed prior to seeking the advice of a physician. In order to properly diagnose this condition mediana recommends that all potential users of the aed as...

  • Page 11: Description of The Aed

    7 description of the aed top and right panel components figure 1. Top and right panel components 1 cover cover shields the led indicator, the power on/off button, the speaker, the shock button. 2 status indicator status indicator displays the unit status and the battery status. 3 pad connector pad c...

  • 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

    9 symbols and labels the following symbols may be used in this manual, related documentation, or appear on system components or packaging. Table 1. Panel and label symbols symbols description symbols description ready to use ce mark not ready to use caution battery capacity follow instructions for u...

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    10 this page is intentionally left blank..

  • Page 15: Setting Up The Aed

    11 setting up the aed warning: to ensure accurate performance and prevent aed failure, do not expose the aed to extreme moisture, including direct exposure to rain. Such exposure may cause inaccurate performance or aed failure. Refer to specification section. Warning: using damaged or expired aed or...

  • Page 16

    12 soft carry case warning: the aed should not be used on someone who is responsive when shaken or breathing normally. The soft carry case has been designed to allow the aed not to move in the soft carry case by using the aed’s own handle. The user can check the status indicator of aed without havin...

  • Page 17

    13 setting up the aed warning: use only mediana-approved and specified parts, accessories, optional parts, consumables, and components. Use of unauthorized accessories may cause the device to operate improperly and provide false measurements. Follow all labeling instructions on the defibrillation pa...

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    14 this page is intentionally left blank..

  • Page 19: Battery Operation

    15 battery operation warning: test battery regularly, when the voltage of battery is very low. A battery that does not pass its test might shut down expectedly. Warning: do not use a battery that is damaged, leaking, or wet. Warning: do not use or store the battery in a place that may be exposed to ...

  • Page 20

    16 replacing the battery 1. Turn off the aed. 2. Push the hole on the left side using the small regular (-) screwdriver. 3. Carefully remove the battery pack. 4. Insert the new battery pack carefully. The aed uses the non-rechargeable battery. Used battery is changed to new battery. Before turning o...

  • Page 21

    17 self test before using the aed, confirm that the aed is working properly and is safe to use as described below. Warning: if the self test is not completed successfully, do not try to use the aed. Caution: when power is applied, the aed automatically starts the self test, which tests the aed circu...

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  • Page 23: Using The Aed

    19 using the aed warning: the aed should not be used on someone who is responsive when shaken or breathing normally. Warning: do not use the pads if the pad gel is dried or the pad is damaged. Warning: disconnect non-defibrillation protected electronic devices or equipment from patient before defibr...

  • Page 24

    20 2010 cpr guidelines perform the cpr call for help, get aed person not responsive? No signs of life? Address person and shake on shoulder! Engage other people to help you and alternate cpr! Open the airway, check for breathing. If the user is not a healthcare provider, the sequence for assessment ...

  • Page 25

    21 operating the aed warning: for pediatric use, or for use on patients between 1-8 years old or kg. (55lb) please remove adult pads and insert pediatric pads if available. Refer to operating instructions for pediatric pads supplied with that aed. If not available, aha/erc guidelines suggest continu...

  • Page 26

    22 step 1 “check 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

    23 step 5 remove clothes to expose the patient's chest. If the patient has an excessively hairy chest, shave the area where the pads are about to be applied. “remove clothes from the patient’s chest. Place pads exactly as shown in the picture. Press pads firmly to patient’s bare chest.” when pads ar...

  • Page 28

    24 note: if “no shock advised”, the aed will move to step 8 which demonstrate cpr progress directly. Note: the aed performs the step 6 directly when it is turned on after the rescuer attaches the pads to the patient properly. Also, the step 6 would be started if the pads are attached to the patient ...

  • Page 29

    25 step 8. Or move to step 6. → ecg analyzing again. → shockable rhythm → move to step 7. → move to step 8 after disarm. “low battery, replace new battery.”: move to step 1 after replace the new battery and complete the power on self test. Aha 2010 configuration after the electric shock is delivered...

  • Page 30

    26 note user and bystander safety warning: make sure no one is touching the patient before you press the shock button. Loudly announce, “stand back! Do not touch the patient.” and look down the entire length of the patent to ensure there is no contact before pressing the shock button. Do not touch t...

  • Page 31: Maintenance

    27 maintenance warning: improper maintenance may damage the aed or cause it to function improperly. Maintain the aed according to directions. Warning: do not let fluids to get into the aed. Avoid spilling any fluids on the aed or its accessories. Spilling fluids into the aed may damage it or cause a...

  • Page 32

    28 3. Check the exterior of the aed for cracks or other signs of damage. Contact your distributor or mediana technical support immediately if any damage is found. 4. Check the exterior of the aed for dirt or contamination. If necessary, clean aed with approved cleaning products. 5. Check supplies, a...

  • Page 33

    29 cleaning to clean the aed, wipe the aed with a soft cloth that has been dampened by one of the following: soapy water isopropyl alcohol (70% solution). For cables and pads, follow cleaning instructions in the directions for use shipped with those components. Avoid spilling liquid on the aed, espe...

  • Page 34

    30 the aed maintenance mediana recommends users perform regular maintenance checks. A suggested maintenance check would be. 1. Check the status indicator. If the status indicator displays “x”, a problem has been detected. Refer to the troubleshooting section of this manual. 2. Check the use by date ...

  • Page 35: Troubleshooting

    31 troubleshooting warning: if you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the aed is functioning correctly. Warning: to reduce the risk of electrical shock, do not attempt to remove the cover under any circumstances. Th...

  • Page 36

    32 emi (electromagnetic interference) warning: keep patients under close surveillance during delivering a shock. It is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and the aed can cause inaccurate measurement readings. Do not rely entirely o...

  • Page 37: Glossary

    33 glossary sudden cardiac arrest (sca) sudden cardiac arrest is a condition in which the heart suddenly stops pumping effectively due to a malfunction of the heart's electrical system. Often victims of sca have no prior warning signs or symptoms. Sca can also occur in people with previously diagnos...

  • Page 38

    34 detecting fibrillation the electrical rhythm by which the heart muscle contracts can be detected and used for medical diagnosis and the resulting reading is called an electrocardiogram (ecg). The aed has been designed to analyze a patient’s ecg in order to detect ventricular fibrillation (vf) in ...

  • Page 39: Specification

    35 specification defibrillation electric shock waveform biphasic truncated exponential (bte) waveform (impedance compensation) energy adult: 185 to 200j (±5%) pediatric: 45 to 50j (±5%) operating mode semi-auto ecg lead ii (ra, ll) patient impedance 25 to 175 ohm heart rate 20 to 300 per min accurac...

  • Page 40

    36 environmental conditions operation temperature 0 to 43°c (32 to 109.4°f) relative humidity 5 to 95% rf (non-condensing) altitude 0 to 4,575 m shock acceleration: 100 g (+/- 10%) time: 6 msec the number of shocks: 3 times/axis (6 axes (+/- x, y, z) vibration frequency: 10hz to 2000hz acceleration ...

  • Page 41

    37 accessories specifications pads adult pads standby life 2 years from manufacture date electrodes disposable pads placement anterior-lateral active gel area 96.25 cm 2 cable length 1.7 m pediatric pads (option) standby life 2 years from manufacture date electrodes disposable pads placement anterio...

  • Page 42

    38 defibrillation defibrillation waveform waveform parameters waveform parameters are automatically adjusted as a function of patient defibrillation impedance. In the diagram at left, a is the width of pulse 1 and b is the width of pulse 2 of the waveform, c is the inter-pulse delay, i p is the peak...

  • Page 43

    39 ecg analysis performance rhythm class ecg analysis performance shockable rhythm, ventricular fibrillation complies with iec60601-2-4:2002 (sensitivity > 90%) shockable rhythm, ventricular tachycardia complies with iec60601-2-4:2002 (sensitivity > 75%) non-shockable rhythm complies with iec60601-2...

  • Page 44

    40 compliance item standard description classification iec60601-1:1988 +a1:1991+a2:1995, en 60601-1:1990 +a1:1993 +a2:1995 +a13:1996 internally powered (on battery power) type of protection iec60601-1:1988 +a1:1991+a2:1995, en 60601-1:1990 +a1:1993 +a2:1995 +a13:1996 type cf – applied part mode of o...

  • Page 45

    41 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...

  • Page 46

    42 item standard description en60068-2-31:2008 rough handling shocks, primarily for equipment- type specimens labeling en1041:2008 information supplied by the manufacturer with medical devices marking iec /tr60878:2003 graphical symbols for electrical equipment in medical practice en980:2008 graphic...

  • Page 47

    43 manufacturer’s declaration warning: for best product performance and measurement accuracy, use only accessories supplied or recommended by mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. The use of accessories, transducers, and cables oth...

  • Page 48

    44 table 6. Electromagnetic immunity (iec60601-1-2) (continued) immunity test iec60601 test level compliance level electromagnetic environment guidance the aed is intended for use in the electromagnetic environment specified below. The customer or the user of the aed should assure that it is used in...

  • Page 49

    45 table 7. Recommended separation distances recommended separation distance between portable and mobile rf communications equipment and the aed the aed is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled. The customer or the user of the aed can hel...