Mediana hearton aed a10 Operator's Manual
Mediana hearton aed a10 is an easy-to-use automated external defibrillator (AED) that can help save the life of someone who is experiencing sudden cardiac arrest (SCA). The AED is designed to be used by laypeople, and it provides clear and concise instructions on how to use it. The AED is also equipped with a variety of features that make it ideal for use in a variety of settings, including schools, offices, and public places.
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OPERATOR’S MANUAL
HeartOn A10
®
Automated External Defibrillator
EU representative
OBELIS S.A
Bd. Général Wahis, 53, 1030 Brussels, Belgium
Manufacturer
Mediana Co., Ltd.
132, Donghwagongdan-ro,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: (82) 2 542 3375 (82) 33 742 5400
Fax: (82) 2 542 7447 (82) 33 742 5483
HeartOn A10
®
Operator’s Manual
Revised Date: 0713
Part Number-Revision: A7131-3
Copyright © 2013 All rights reserved.
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 contact our service center.
The manual will be replaced if any pages are missing or collation is incorrect.
Warranty
Device failure or damage related to the following situations during the guarantee period is not covered by this warranty:
Installation, transfer installation, maintenance and repairs by any person other than an authorized Mediana. employee or technician specified by Mediana.
Damage sustained to the Mediana product(s) caused by product(s) from another company excluding products delivered by Mediana.
Damage – caused by mishandling and/or misuse – is the responsibility of the user.
Maintenance and repairs utilizing maintenance components that are not specified
by Mediana.
Device modifications or use of accessories not recommended by Mediana.
Damage caused 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 attachment of accessories or their operation.
In the event of a defect in the product, contact our sales outlet or EU representative as noted on the back cover.
The HeartOn A10 conforms to the EMC standard IEC60601-1-2.
Note: It is possible that using in the vicinity of mobile phone may result in disruption in the AED operation.
Revision History
The documentation part number and revision number indicate its current edition. The revision number changes when a new edition is printed in accordance with the revision history of the documentation. Minor corrections and updates which are incorporated at reprint do not cause the revision number to change. The document part number changes when extensive technical changes are incorporated.
Trademark
Product brand names shown in this manual are likely to be the trademark or registered trademark of the company concerned.
CONTENTS
CONTENTS .................................................................................................................................................... i
SAFETY INFORMATION .............................................................................................................................. 1
General Safety Information ................................................................................................................... 1
Warning ................................................................................................................................................. 1
Cautions ................................................................................................................................................ 3
INTRODUCTION ........................................................................................................................................... 5
Intended Use for the AED ...................................................................................................................... 5
About This Manual ................................................................................................................................. 5
Training .................................................................................................................................................. 6
Training .................................................................................................................................................. 6
DESCRIPTION OF THE AED ....................................................................................................................... 7
Top and Right Panel Components ......................................................................................................... 7
Bottom Panel Components ................................................................................................................... 8
Rear Panel Components ....................................................................................................................... 8
Symbols and Labels .............................................................................................................................. 9
SETTING UP THE AED .............................................................................................................................. 11
Unpacking and Inspection ................................................................................................................... 11
List of Components .............................................................................................................................. 11
Soft Carry Case ................................................................................................................................... 12
SD card ................................................................................................................................................ 12
IrDA port .............................................................................................................................................. 12
Setting up the AED .............................................................................................................................. 13
BATTERY OPERATION .............................................................................................................................. 15
Operating the AED on Battery Power .................................................................................................. 15
Battery 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
Service ................................................................................................................................................. 28
Periodic Safety Checks ....................................................................................................................... 28
Cleaning .............................................................................................................................................. 29
Battery Maintenance ........................................................................................................................... 29
Pads Maintenance ............................................................................................................................... 29
The AED Maintenance ........................................................................................................................ 30
TROUBLESHOOTING ................................................................................................................................ 31
General ................................................................................................................................................ 31
Corrective Action ................................................................................................................................. 31
EMI (Electromagnetic Interference) ..................................................................................................... 32
Obtaining Technical Assistance ........................................................................................................... 32
GLOSSARY................................................................................................................................................. 33
SPECIFICATION ......................................................................................................................................... 35
Compliance .......................................................................................................................................... 40
Manufacturer’s Declaration ................................................................................................................. 43
i
Figures
Figure 1. Top and Right Panel Components ................................................................................................. 7
Figure 2. Bottom Panel Components ............................................................................................................ 8
Figure 3. Rear Panel Components ................................................................................................................ 8
Figure 4. Battery Placement ........................................................................................................................ 15
Figure 5. Action Icon – Step 1 ..................................................................................................................... 22
Figure 6. Action Icon – Step 2 ..................................................................................................................... 22
Figure 7. Action Icon – Step 3 ..................................................................................................................... 22
Figure 8. Action Icon – Step 4 ..................................................................................................................... 22
Figure 9. Action Icon – 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 (IEC60601-1-2) (continued) ................................................................ 44
Table 7. Recommended Separation Distances ........................................................................................... 45
Table 8. Cables (IEC60601-1-2) .................................................................................................................. 45
ii
SAFETY INFORMATION
General Safety Information
This section contains important safety information related to general use of the HeartOn
A10
A10
®
®
. Other important safety information appears throughout the manual. The HeartOn
will be referred to as the AED throughout this manual.
Before use, carefully read operator’s manual, accessory directions for use, all precautionary information and specifications.
Warning
Warnings are identified by the WARNING symbol shown above.
Warnings alert you to potential serious outcomes (death, injury, or adverse events) to the patient or user.
WARNING: As a user of an AED it is essential that you inform Mediana of any incident where your AED is suspected to have caused a death, serious injury or illness. If you have any suspicions that this is the case inform Mediana directly or through your authorized Mediana dealer.
WARNING: The AED must be used by a person trained in CPR and the use of
AED. The qualification for the usage of AED should follow the local laws.
WARNING: The AED has the capability to deliver therapeutic electrical shocks.
The shock can cause serious harm to either operators or bystanders. 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 unresponsive, non-breathing and pulseless* patients. If the patient is conscious or breathing, do not use the
AED to provide treatment. (*: healthcare provider only)
WARNING: Touching the patient during the analysis phase of treatment can cause interference with the diagnostic process. Avoid contact with the patient and keep the patient as while ECG analysis is being carried out. The AED will instruct you when it is safe to touch the patient.
WARNING: Always stand clear of patient when delivering treatment. Defibrillation energy delivered to the patient may be conducted through the patient’s body and cause a lethal chock to those touching the patient.
WARNING: It has been determined that the AED is safe to use in conjunction with oxygen mask delivery systems. However, due to the danger of explosion it is strongly advised that the AED should not be used in the vicinity of explosive gases. This includes flammable anesthetics or concentrated oxygen.
1
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 positioning instructions, as indicated on the labeling and in training, is essential.
Care must be taken to ensure pads are adhered to the patients' skin properly. Air pockets between the adhesive pad and skin must be eliminated. Failure in pad adhesion may hinder effectiveness of therapy or cause excessive skin burns to the patient if a shock is applied. Reddening of the skin may appear after use, this is normal.
WARNING: The battery of AED is not rechargeable. Do not try to recharge, open, crush, or burn the battery, or it may explode or catch fire.
WARNING: Do not allow the pads to contact other electrodes or metal parts that are in contact 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 the AED can cause death or injury.
WARNING: Do not use or place the AED in service if the status indicator of AED displays “X”.
WARNING: Keep batteries dry and away from any heat sources (including direct sunlight). If you see any damage or leakage, do not allow the liquid to come in contact with your skin or eyes. If contact has been made, wash the affected area with plenty of water and seek medical advice immediately.
WARNING: The AED contains an automatic disarm of the stored energy. If the operator has not delivered the energy to a patient, an internal timer will disarm the stored energy. This stored electrical energy can potentially cause death or injury if discharged improperly. Follow all instructions in this manual.
2
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 this manual.
CAUTION: The
AED was designed to be sturdy and reliable for many different use
conditions. However, handling the AED too roughly can damage it or its accessories and will invalidate the warranty. Check the
AED and accessories
regularly for damage, according to directions.
CAUTION: Before delivering a shock, it is important to disconnect the patient from non-defibrillation protected electronic devices, such as blood-flow meters, that may not incorporate defibrillation protection. In addition, make sure the pads are not in contact with metal objects such as a bed frame or stretcher.
CAUTION: The pads pouch shall not be opened until immediately prior to use.
CAUTION: Do not use or 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 things that the AED is not damaged in any way.
CAUTION: The pads are a single use item and must be replaced after each use or if pouch that seals pads has been broken/compromised in any way. If damage is suspected the pads must be replaced immediately.
CAUTION: Do not use training pads with this AED.
CAUTION: Carefully observe pacemaker patients. Patient history and physical examination are important in determining the presence of implanted pacemaker.
Patient pacemakers may reduce the sensitivity of the AED analysis and errors in detecting shockable rhythms.
CAUTION: If the pads are attached to the chest firmly, the AED can analyze the exact ECG and prevent the skin burns. But if the pads are overlapped on the patient chest, the pads will not deliver defibrillation energy properly.
3
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4
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 Care (ECC). You should have been trained in the appropriate version of the AHA/ERC guidelines and the use of your AED configuration.
Contact Mediana or your authorized Mediana distributor for further information.
Intended Use for the AED
The AED is intended to be used to treat someone who is unresponsive, non-breathing and pulseless for the adult and pediatric in all area of a hospital, pre-hospital, public access, alternate care and home healthcare environment. AED users should be skilled at level of a doctor, nurse, medical specialist or trained user.
Note: Hospital use typically 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 treated with the appropriate pads.
Note: The AED is intended for trained user who knows how to use the AED. Potential user should be trained in cardiopulmonary resuscitation (CPR), the use of the AED.
Many training institutes have courses that combine performing CPR and using the
AED. The training course can be accomplished for various durations, but crash course/most basic course can be accomplished in one day. For further information on training course, contact your local authorized supplier or Mediana technical support.
About This Manual
This manual explains how to set up and use the AED.
Read the entire manual including the Safety Information section, before you operate the
AED.
5
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 a minimum, are fully trained in cardiopulmonary resuscitation (CPR), the use of the AED, specifically the AED. It is also recommended that this training be kept up to date by means of regular refresher courses and when recommended by your training provider. If potential users of the AED are not trained in these techniques contact your Mediana 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 the AED
Physical/Mechanical
The AED is an automated external defibrillator (AED) used for the fast delivery of defibrillation electric shock therapy which can be battery-operated.
Electrical
The AED has an internal battery which is the non-rechargeable battery.
Display
The indication is LED indicator that flashes red LED under the relevant action icon.
Auxiliary Input/Output(s)
The AED provides Infrared communication port, SD card ports.
6
DESCRIPTION OF THE AED
Top and Right Panel Components
1
2
3
6
7
8
4
5
9
10
Figure 1. Top and Right Panel Components
1 Cover
Cover shields the LED indicator, the power on/off button, the speaker, the shock button.
Status indicator displays the unit status and the battery status.
Pad connector links the pads.
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.
9 SD card port
Push button opens the cover.
Shock button delivers the shock.
SD card is used to save the data and update the AED firmware.
10
Infrared communication port
Infrared communication port is used to communicate with the PC.
7
Bottom Panel Components
1
Rear Panel Components
Figure 2. Bottom Panel Components
1
1. Handle
Figure 3. Rear Panel Components
8
Symbols and Labels
The following symbols may be used in this manual, related documentation, or appear on system components or packaging.
Symbols Description
Table 1. Panel and Label Symbols
Symbols Description
Ready to use CE mark
Not ready to use Caution
Battery capacity
Contains no latex
Use by date
EU representative
Manufacturer
Follow instructions for use
Environmental shipping/storage altitude limitations
Environmental shipping/storage humidity limitations
Environmental shipping/storage temperature limitations
Fragile-handle with care
Date of manufacture This way up
Reference number Keep dry
Serial number
Type CF – Defibrillator proof
Single patient use only Dust and water resistance
Disposal instructions UL mark
9
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10
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 accessories may cause the AED to perform improperly, and/or injury the patient or the user.
Unpacking and Inspection
The AED is shipped in one carton. Examine the AED including the accessories carefully for evidence of damage. Do not use damaged equipment. Refer to the Maintenance section for instructions on returning damaged items. Ensure all potential users are suitably trained.
Note: Inspect the packaging of accessories 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
HeartOn A10
®
Operator’s manual
Adult Pads (1.7m)
Non-rechargeable LiMnO
2
Battery (15V, 4200mAh)
Soft Carry Case
Optional Accessories
Pediatric Pads (1.7m)
SD card (2Gbyte)
HeartOn A10 Event Review Software
HeartOn A10 Event Review Software - User Guide
Infrared communication adaptor
Recommended Accessories
Scissors – for cutting the victim’s clothed if needed
Disposable gloves – to protect the user
A disposable razor – to shave the chest if hair prevents good pads contact
A pocket mask or face shield – to protect the user
A towel or absorbent wipes – to dry the victim’s skin for good pads contact
Qty
-
-
-
-
-
Qty
-
-
-
-
-
Qty
1
1
1
1
1
11
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 having to open the carry case. The paper with contact information of the nearest emergency medical services can be inserted to the clear cover. The soft carry case has the pocket on the rear side of the carry case for the manual and spare pads. Other two pockets on the right and left side of the carry case are used for spare battery.
SD card
The SD card is inserted into the SD card port on the AED’s right panel as described below. The SD card is used to record the history of the AED performance and to update the AED 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 card into the SD card port.
4. Close the SD card port cover.
5. Turn on the AED by pressing the Power on/off button.
6. After complete the update, automatically turn off itself.
Infrared communication port
Infrared communication port provides wireless communications from the AED to a PC through the Infrared communication data download cable and DC adaptor which is connected to PC. The Infrared communication is used to update the AED firmware and to transfer information and to connect to service mode. If you want to use Infrared communication port, please contact qualified service personnel or your local supplier.
12
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 pads and the battery.
WARNING: Always follow your facility’s infection control procedures and applicable regulations when disposing of anything that has been used on patients.
CAUTION: Do not open the pads from packaging previously until the time of emergency use when pads are used for patient.
Install 1
1. Remove defibrillation pads from its packaging.
2. To open the cover, press the Push button.
3. Plug in defibrillation pads.
Note: When pads are already connected to the AED in packaging, take out the AED from the packaging and then move to Install 2.
Note: Do not open defibrillation pads protective packaging until the time of emergency use when they are applied to a patient.
Note: To prepare of an emergency, pads must be 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
“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 defibrillation pads inside the AED.
Install 3
Place the AED into its Soft Carry Case.
Install 4
Put into a storage or safe visible location.
The AED should be kept in a convenient central area. Place it near a telephone so that the rescuer can call Emergency Medical Services and retrieve the AED without wasting time. Some important points to remember when storing:
Store the AED in a suitable location for easy access.
Do not lock the location where AED is being placed.
Store the AED in a clean and dry environment.
Install the AED in the environmental operation condition described in this manual.
Make all necessary arrangements to ensure that the AED is accessible at all times.
Inform any possible users of the location of the AED.
Note: Storage differs in some countries. Ask qualified service personnel or your local supplier.
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14
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 high temperature.
CAUTION: To ensure the availability of adequate power during an emergency, keep a fully charged spare battery pack with the AED at all times.
CAUTION: When the voltage of the battery is very low, it is a possibility 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 on, turned off or discharged, battery standby life will not last longer than the intended standby life by manufacturer.
Operating the AED on Battery Power
The AED has an internal non-rechargeable battery. The battery status icon appears on the Status indicator when the AED is on battery power.
Figure 4. Battery Placement
15
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 on the AED with a battery that has been completely discharged, first replace the battery. The AED may then be powered on.
Battery Status Indication
A new battery’s life time is as below;
- Shelf life (in the original packaging): 2 years from manufacture date when stored and maintained according to direction provided in the operator’s manual.
- Standby life (inserted in the AED): 5 years from manufacture date when stored and maintained according to direction provided in the operator’s manual.
- Discharge: A minimum of 200 shocks (excepting the CPR period between the defibrillation 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. Using other types of replacement batteries may result in damage to the AED and void the limited warranty.
When operating on batteries, the battery status icon in the status indicator indicates the battery condition. See Table 3.
Table 3. The Battery Status Icon
Battery Status Icons Battery Status
full charged
(≤ 200 shocks or 10 hours of operating time) used used (≤ 9 shocks) discharged (no shock)
If you hear the voice prompt “low battery, replace new battery” when the AED is turned on or is being used, the AED would be available 9 shocks. If the last bar of the battery indicator is invisible, buzzer would be sounded 2 times and then turned off automatically.
16
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 circuitry and functions. During performing Power On Self Test(POST), confirm that the AED status indicator turns on. If the AED status indicator does not function properly, do not use the AED. Instead, contact qualified service personnel or your local supplier.
Performing Power On Self Test (POST)
1. Turn on the AED by pressing the Power on/off button.
2. The AED automatically starts the Power On Self Test (POST).
3. If the AED detects an error during POST, the status indicator will display “X”. Contact qualified service personnel or your local supplier for assistance.
4. Upon successful completion of the POST, the AED sounds voice prompt “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.
Daily self test : MCU and Memory(RAM, ROM) integrity, Battery capacity, ECG algorithm
Weekly self test : Waveform delivery circuit low (2J) energy test, ECG circuit test in addition to the daily self test
Monthly self test : Waveform delivery circuit high (50J) energy test in addition to the weekly self test
Note: When the battery is discharged, the status indicator displays “X”. Contact qualified service personnel or your local supplier if the status indicator still displays “X” after replace the new battery.
Note: Self test is not able to determine if the battery and the pads currently inserted in
AED are within their use by date. You must remember to check the use by date on the pads and standby life on the battery regularly.
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18
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 defibrillation.
WARNING: Never lift the AED by the pads cable or any other accessory. Such accessories could detach, causing the AED to fall on the patient.
CAUTION: Prolonged or aggressive CPR to a patient with pads attached can damage the pads. Replace the pads if they are damage during use or handling.
The AED is designed for the treatment of sudden cardiac arrest (SCA). It should only be used to treat someone who may be a victim of a SCA and is:
Unresponsive,
Non-breathing,
Pulseless, (healthcare provider only)
If the person is unresponsive but you are unsure that they have suffered from a SCA begin CPR. When appropriate apply the AED and follow the voice prompts.
2010 AHA Guidelines for CPR and ECC
The 2010 AHA Guidelines for CPR and ECC are based on the most current and comprehensive review of resuscitation 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 has been simplified, and “Look, Listen and Feel” has been removed from the algorithm. Performance of these steps in inconsistent and time consuming.
(The use for non-healthcare provider)
Encourage Hands-only (compression only) CPR for the untrained lay rescuer. Hands-
Only CPR is easier to perform by those with no training and can be more readily guided by dispatchers over the telephone.
Initiate chest compressions before giving rescue breaths. (Compression-Airway-
Breathing rather than Airway-Breathing-Chest compressions)
There is an increased focus on methods to ensure that high-quality CPR is performed. The following action put emphasis on the important factor of high-quality
CPR.
- Adequate chest compressions (100 ~ 120/min)
- Compression depth of at least 2 inches (5 cm) in adults
- Allowing complete recoil of the chest after each compression
- Minimizing any pauses in compressions
- Avoiding excessive ventilation
19
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 of breathing after opening the airway might be eliminated.
Open the airway.
Check for breathing!
Note: “Open the airway, check for breathing” is removed from the CPR sequence for assessment of breathing after opening the airway in 2010 guidelines. But 2010 guideline recommends that the healthcare provider briefly checks 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
ANALYSIS SHOCK DECISION
Repeat every 2 minutes.
YES
DELIVER SHOCK
NO
Continue CPR for about 5 cycles
(approximately 2minutes)
Pre Defibrillation Action
Prior to using the AED, it is advised to perform the following checks and actions in order to prepare the patient:
Remove clothes to expose bare chest.
If excessively hairy shave hair from areas to which defibrillation pads are to be applied.
Ensure that the patient chest is dry. If necessary, dry chest area.
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Operating the AED
WARNING: For Pediatric use, or for use on patients between 1-8 years old or <25 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 continuing to defibrillate if required using the Adult configured system.
WARNING: If the pads placement is inappropriate, the AED could harm the patient.
To place the accurate position, must follow the voice prompt and action icon.
When pads placement is inappropriate, treatment could not work or shock could burn the patient’s skin.
WARNING: Do not place pads near the generator of an internal pacemaker. The analyzing heart rhythm of patient who is implanted pacemaker could inaccurate or the pacemaker might be damaged by defibrillator discharges.
WARNING: Do not perform chest compressions (CPR) through electrodes. These actions may damage the electrode pads cause the AED to function improperly.
WARNING: Always apply pads to flat areas of skin. Avoid application over folds of skin such as those underneath the breast or on obese patients. Excessive hair, poor adhesion, or air under pads may produce burns or ineffective energy transfer.
WARNING: To apply the pads to patient chest properly, shave hair from areas which defibrillation 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 being carried out. The AED will instruct you by voice prompt when it is safe to touch the patient.
WARNING: The AED delivers shocks which can cause serious harm to operators and bystanders. Caution must be taken to ensure no-one is in contact with the patient when a shock is delivered.
Note: Only pads supplied by Mediana should be used. Using other types of pads may result in damage to the patient and AED.
1. Check the status indicator displays “O”.
2. Press the Push button to open the cover.
3. Turn on the AED by pressing Power On/off button.
4. The AED automatically starts the Power-On-Self Test.
5. The test result is displayed on the status indicator and the voice prompt sounds.
Self test is passed : Voice prompt “Unit ok”, Status indicator “O”
Self test is failed : Voice prompt “Unit failed”, Status indicator ”X”
6. If the pad is not inserted you will hear the voice prompt:
“Plug in pads. Insert connector firmly”
If the pad is inserted you will hear the voice prompt:
“Adult pads” or “Pediatric pads”
7. Verify the AED is activated normally and follow voice prompt and action icon. The red
LED will flash under the relevant action icon.
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STEP 1
“Check for response. Are you all right?”
STEP 2
“Call for help.”
Figure 5. Action Icon – Step 1
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STEP 3
“Open the airway.”
Figure 6. Action Icon – Step 2
STEP 4
“Check
Figure 7. Action Icon – Step 3
Figure 8. Action Icon – Step 4
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 are disconnected to the AED, the following voice prompt will be 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
STEP 6
WARNING: Apply freshly opened and undamaged pads, within use by date, to clean and dry skin to minimize burning.
When the pads are attached correctly to the patient you will hear the voice prompts:
“Analyzing heart rhythm. Do not touch the patient.”
“Shock advised. Charging. Do not touch the patient.” or
“Analyzing heart rhythm. Do not touch the patient.”
“No advised”.
Figure 11. Action Icon – Step 6
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STEP 7
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 even if the AED is under the Step 1 to 5. This can reduce the preparing time for electric shock in case of trained rescuer.
Note: Follow voice prompt. Do not touch patient or allow any others to touch the patient while the AED is analyzing. After completion of analysis the AED will advise you of treatment recommended. Care must be taken to keep the patient still. A moving patient can lead to incorrect, delayed or less effective diagnosis and therapy.
“Press the shock button now.”
“Deliver shock now.”
“Shock delivered.” or “Shock button not pressed.”
STEP 8
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.
“It is safe to touch the patient.”
“Begin CPR.” [Beep] or “If needed, Begin CPR.” [Beep]
“Give two breaths.”
“Stop
Figure 13. Action Icon – Step 8
Note: After finished the STEP8, the AED will move to the STEP 6 to analyze heart rhythm again.
Note: If you hear following voice prompt while the AED is analyzing you should perform the following actions:
Rhythm changed, “Shock cancelled.”:
Move to Step 8. → Perform the CPR.
“Shock button not pressed.” or “Disarms.”:
Move to Step 6. → ECG analyzing again. → non-shockable rhythm → Move to
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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, the following voice prompt would be emitted.
“It is safe to touch the patient.”
“Begin
Use the metronome sound from the AED for compression rate – the unit emits a tone corresponding at least more than 100 beats per minute (to current AHA guidelines). Note too that the “Begin CPR.” Icon flashes at the same rate for additional guidance. At this point, adequate chest compressions require that compressions be provided at the compression depth of at least 2 inches (5 cm) in adults.
Rescuer performs 5 cycles of CPR, each cycle include 30 times of chest compression and 2 times of rescue breath at the 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
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 will be lasted until emergency physician arrives and then hand over patient to emergency physician.
Note Performing CPR
When performing CPR watch and listen to the AED, the voice prompt “Begin CPR” will flash. The AED emit beeps and flashing action icon at the rate of 100 times per minute and “Give two breaths.” Voice prompt as a guide to CPR.
At least more than 2 inches (5cm) of compression depth and 100 – 120 beats per minutes of rate are the recommended compressions under AHA 2010 guidelines.
Note: Your Mediana dealer will have trained you in the particular SCA treatment protocol you have chosen. In all cases follow the voice prompts and visual instructions given by the AED.
25
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 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 heart is in need of a shock.
Note: See warnings and cautions for more details.
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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 fire or electric shock hazard. Do not sterilize the AED or its accessories.
WARNING: Do not immerse any part of the AED in water or any type of fluid.
Contact with fluids may seriously damage the AED or cause fire or electric shock hazard.
WARNING: WARNING: Do not attempt to warm the electrodes with a heat source greater than 35°C (95°F).
WARNING: Do not clean the AED with abrasive materials, cleaners or solvents.
CAUTION: Follow local government ordinances and recycling instructions regarding disposal or recycling of AED components, including batteries.
CAUTION: Do not short-circuit the battery, as it may generate heat. To avoid shortcircuiting, do not let the battery come in contact with metal objects at any time, especially when transporting.
CAUTION: Do not solder the battery directly. Heat applied during soldering may damage the safety vent in the battery’s positive cover.
CAUTION: Do not deform 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 by Mediana.
CAUTION: Keep the battery out of reach of babies and children to avoid any accidents.
CAUTION: If there are any problems with the battery, immediately put the battery in a safe place and contact qualified service personnel or your local supplier.
CAUTION: Replacing new battery and placing the pads should carry out in environmental conditions described in this manual. If the AED is operated in out-ofrange for environmental conditions, the AED can’t be operated properly.
After using the AED, Mediana technical support recommend you perform the following actions:
1. Use the HeartOn A10 Event Review Software to download information about the therapy performed and store appropriately. (If you do not have the HeartOn A10 Event
Review Software, please contact your dealer who can arrange for the incident to be downloaded).
2. Remove the used the pads from your AED and dispose of in a suitable manner. (For recommended disposal methods please refer to section the recycling and disposal)
27
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. immediately if any damage or expiration is found. Contact your local Mediana approved dealer.
6. Install the new pads. Before installing the new pads check that its use by date has not been exceeded.
7. After installation of the new pads. Check the Status Indicator. If the Status Indicator is not displaying “O” refer to the troubleshooting section of this manual. If the problem persists, contact Mediana or your local approved dealer for technical support.
8. Turn on the AED and verify that the AED operates in the correct manner i.e. voice prompt “Unit OK” can be heard. Turn off the AED.
9. Contacting Mediana after use. At Mediana we like to hear from our customers whenever they have any occasion to use any of our products, even if therapy is not delivered as part of the incident. This information is vital to the continued development and constant improvement we strive 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 disposal of your old appliance will help prevent potential negative consequences for the environment and human health.
Note: For more detailed information about disposal of your old appliance, please contact your city office, waste disposal service or the shop where you purchased the AED.
Returning the AED and System Components
To return the AED and/or accessories, contact qualified service personnel or your local supplier.
Service
The AED requires no routine service other than cleaning, battery maintenance, and service activity which is mandated by the user’s institution. For more information, refer to the AED service manual. Qualified service personnel in the user’s institution should perform periodic inspections of the AED. If service is necessary, contact qualified service personnel or your local supplier.
Periodic Safety Checks
It is recommended that the following checks be performed every year.
Inspect the equipment for mechanical and functional damage.
Inspect the external safety labels for legibility.
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Cleaning
To clean the AED, wipe the AED with a soft cloth that has been dampened by one of the following:
Soapy
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, especially in connector areas. If liquid is accidentally spilled on the AED, clean and dry thoroughly before reuse. If in doubt about AED safety, refer the unit to qualified service personnel or your local supplier for checking.
Battery Maintenance
The battery lifetime in use can be up to 10 hours monitoring or 200 shocks (excepting the
CPR period between the defibrillation therapy) or a combination of both. The battery in the standby mode (inserted into the AED) has standby life (5 years from manufacture date). If the battery status indicator is flashing one bar, you 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 use item) it must be replaced with new pads.
The package of new pads has been previously damaged.
The pads have been vent.
Replacing Pads
1. Take the replacement pads from its protective bag.
2. Remove the old pads which are to be replaced.
3. Push the pads firmly to ensure it is fully inserted.
4. Turn on the AED.
5. Check status indicator. If the pads have been inserted correctly, Status Indicator displays “O” after approximately 6 seconds.
6. If necessary inform relevant safety officer or person responsible for maintenance of the
AED.
7. Update the relevant records to show the date that the replacement the pads was placed into service.
8. Dispose of the old pads.
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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 of the pads. If the pads have exceeded its use by date, remove it and replace with the pads. Contact qualified service personnel or your local supplier for 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 is easily accessible for those Responders at all times.
6. Ensure all trained responders have up to date training for both CPR and AED use. For recommended retraining intervals please consult the organization or body used to provide the training.
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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. There are no operator serviceable components and only a qualified technician should service the AED.
General
If the AED detects an error, it can display the “X” on the Status indicator. Check the appropriate section or write down the description and contact qualified service personnel or your local supplier. Before calling to qualified service personnel or your local supplier, make sure it meets environmental conditions provided in the manual as temperature, humidity, altitude and so on.
Corrective Action
Check use by date the pads. Change the pads if use by date has been exceeded. Check shelf life or standby life of the battery. Change the battery if the shelf life or standby life has been exceeded.
Following is a list of possible errors and suggestions for corrective action.
If the status indicator is still not displaying “X” or a warning message is heard when AED is turned 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. ( [email protected]
).
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 missing or discharged. If the battery is missing, insert the battery (See Battery Operation section). If the battery is discharged, change the battery (See Maintenance section).
2. The beep tones do not sound during the operation.
Do not use the AED; contact qualified service personnel or your local supplier.
3. The beep tones sound but voice does not function properly.
Reconnect the wire or replace the speaker.
4. The voice prompt “Plug in pads. Insert connector firmly”.
Reconnect the pad firmly or replace the pad.
5. The action icon does not flash.
Do not use the AED, contact qualified service personnel or your local supplier.
6. The voice prompt is unclearly heard.
Do not use the AED, contact qualified service personnel or your local supplier.
7. The battery status does not indicate 3 bar despite of replacing new battery.
If the battery status still not displayed 3 bar despite of replacing new battery, do not use the AED and contact qualified service personnel or your local supplier.
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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 on the AED readings for patient assessment.
WARNING: It is possible that any radio frequency transmitting equipment and other nearby sources of electrical noise may result in disruption in the AED operation.
WARNING: It is possible, although unlikely, that large equipment using a switching relay for its power on/off may affect the AED operation. Do not operate the AED in such environments.
This device has been tested and found to comply with the limits for medical devices to the IEC60601-1-2, and the Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care environments (such as electrosurgical equipment, cellular phones, mobile two-way radios, electrical appliances, and highdefinition 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 may be indicated by erratic readings, cessation of operation, or other incorrect functioning. If this occurs, survey the site to determine the source of this disruption. Try the following actions to see if they eliminate the disruption:
Turn equipment in the vicinity off and on to isolate the offending equipment.
Reorient or relocate the interfering equipment.
Increase the separation between the interfering equipment and this equipment.
The AED generates, uses, and can radiate radio frequency energy. If the AED is not installed and used in accordance with these instructions, the AED may cause harmful interference with other devices in the vicinity.
If assistance is required, contact qualified service personnel or your local supplier.
Obtaining Technical Assistance
For technical information and assistance, or to order the AED service manual, call your local supplier. The service manual provides information required by qualified service personnel or your local supplier when servicing the AED.
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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 diagnosed heart conditions. Survival for an SCA victim depends on immediate cardio-pulmonary resuscitation (CPR). The use of an external defibrillator within the first few minutes of collapse can greatly improve the patients' chances of survival. Heart attack and SCA are not the same, though sometimes a heart attack can lead to a SCA. If you are experiencing symptoms of a heart attack (pain, pressure, shortness of breath, squeezing feeling in chest or elsewhere in the body) seek emergency medical attention immediately.
Heart Rhythm
The normal electrical rhythm by which the heart muscle contracts to create blood flow around the body is known as Sinus Rhythm. Ventricular Fibrillation (VF) caused by chaotic electrical signals 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 using the AED.
Sinus Rhythm
Sinus Rhythm is the normal electrical rhythm by which the heart muscle contracts and expands to create blood flow around the body.
Biphasic Shock
A biphasic shock is an electrical current that is passed through the heart, firstly in one direction and then in another.
Biphasic Truncated Exponential (BTE) waveform
Biphasic Truncated Exponential (BTE) waveform stands for Self-Compensating Output
Pulse Envelope Waveform.
Pads
Pads are the electrodes that are connected to the patient's chest in order to administer therapy.
Electromagnetic Interference
Electromagnetic interference is radio interference that may cause erroneous operation of electronic equipment.
Impedance Measurement
Impedance measurement is a check that is performed to check the integrity of AED patient contact.
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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 the heart. If ventricular fibrillation (VF) is detected the AED will deliver a carefully engineered electrical shock designed to stop the chaotic electrical activity experienced within the heart muscle during SCA. This may allow the victim'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 communication cable). It can retrieve and view information about therapy delivered using the AED. Also, HeartOn A10 Event Review Software can be used to configure the AED.
More Information
If you have had any occasion to use your AED or if you require any further information on the AED, its accessories or any other products please contact us.
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SPECIFICATION
Defibrillation Electric Shock
Waveform
Energy
Operating mode
ECG
Lead
Patient impedance
Heart Rate
Accuracy
Detection
Lead off detection
Filter
Indication
Standard
Visible
Audible
Physical
Dimensions
Weight
Biphasic Truncated Exponential (BTE) waveform
(impedance compensation)
Adult: 185 to 200J (±5%)
Pediatric: 45 to 50J (±5%)
Semi-Auto
II (RA, LL)
25 to 175 ohm
20 to 300 per min
1 per min
V/F more than 200 µV
V/T more than 160 per min
Detected and voiced.
0.5 to 30 Hz
Controls
Green Power on/off button, Red Shock button
Indicators
ICON (LED) Indicator, Status LCD
Audio speaker (Voice prompt), Beep (CPR indication)
341 × 259 × 109 (mm) (W×H×D)
Approx. 2.95 kg including the battery
35
Environmental Conditions
Operation
Temperature
Relative Humidity
0 to 43°C (32 to 109.4°F)
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 : 10 Hz to 100 Hz: 5,0 (m/s²)²/Hz
100 Hz to 200 Hz: -7 dB per octave
200 Hz to 2000 Hz: 1,0 (m/s²)²/Hz
Drop height
Water and dust resistance
1m
IP54 (IEC60529)
Temperature
Relative Humidity
Altitude
Storage (in shipping container)
-20 to 60°C (-4 to 140°F)
5 to 95% Non-condensing
0 to 12,192 m
Self Test
Cycle
Test result
Every 24 hours, 1 week, 1 month
Power on self test
Status LCD displays “O”/ “X”.
Data Backup and Communication
Standard SD card, Infrared communication port
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Accessories Specifications
Pads
Standby life
Adult Pads
2 years from manufacture date
Placement Anterior-lateral
Active gel area 96.25 cm
2
Cable length 1.7 m
Standby life
Pediatric Pads (Option)
2 years from manufacture date
Placement Anterior-posterior
Active gel area 69.53 cm
2
Cable length 1.7 m
Temperature
Relative Humidity
Environmental Conditions
Operation:
Storage:
0 to 43°C (32 to 109.4°F)
0 to 43°C (32 to 109.4°F)
5 to 95% Non-condensing
Battery
Battery
Type LiMnO
2
, Disposable, Long-Life Primary Cell
Voltage/Capacity 15V, 4200 mAh
Shelf Life (in the original packaging)
2 years from manufacture date
5 years from manufacture date Standby Life
(inserted in the AED)
Discharge A minimum of 200 shocks (excepting the CPR period between the defibrillation therapy) or 10 hours of operating time at 20°C
Temperature
Relative Humidity
Environmental Conditions
Operation:
Storage:
0 to 43°C (32 to 109.4°F)
0 to 43°C (32 to 109.4°F)
5 to 95% RH (Non-condensing)
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Defibrillation
Waveform parameters
Defibrillation waveform
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 current, and I f
the final current.
The AED delivers shocks to load impedances from 25 to 175 ohms. The duration of each pulse of the waveform is dynamically adjusted based on delivered charge, in order to compensate for patient impedance variations, as shown below:
Load
Resistance (Ω)
Adult defibrillation
Pulse width 1 Pulse width 2
(ms) (ms)
Delivered
Energy (J)
150 11.3 7.9 185
175 11.7 8.7 180
Load
Resistance (Ω)
Pediatric defibrillation
Pulse width 1 Pulse width 2
(ms) (ms)
Delivered
Energy (J)
Charge control
Charging Time
Shock Analysis
Time
100 8.3 5.9 51
125 9.7 6.7 50
150 11.3 7.9 49
175 11.7 8.7 47
Controlled by patient analysis system for automated operation.
< 10 seconds typical
8 to 13 seconds
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ECG Analysis Performance
Rhythm class
Shockable rhythm,
Ventricular Fibrillation
Shockable rhythm,
Ventricular
Tachycardia
Non-Shockable rhythm
ECG analysis performance
Complies with IEC60601-2-4:2002
(sensitivity > 90%)
Complies with IEC60601-2-4:2002
(sensitivity > 75%)
Complies 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
Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm
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Compliance
Item Standard
Classification IEC60601-1:1988
+A1:1991+A2:1995,
EN 60601-1:1990
Type of protection
+A1:1993 +A2:1995
+A13:1996
IEC60601-1:1988
+A1:1991+A2:1995,
EN 60601-1:1990
+A1:1993 +A2:1995
+A13:1996
Mode of operation
Degree of protection
IEC60601-1:1988
+A1:1991+A2:1995,
EN 60601-1:1990
+A1:1993 +A2:1995
+A13:1996
IEC60529:2001,
EN60529:1991+A1 2000
General 93/42/EEC as amended by 2007/47/EC
21CFR820
2012/19/EU
93/86/EEC
2006/66/EC as amended by 2008/103/EC
EN ISO13485:2012
/AC:2012
Description
Internally powered (on battery power)
Type CF – Applied part
Continuous
IP54 (provided by enclosures)
Medical Device Directive (class IIb)
Code of federal regulations
Waste Electrical and Electronic Equipment
Battery disposal directive
Battery directive
Requirements for regulating purposes
EN ISO14971:2012 devices
+A1:1991+A2:1995,
EN60601-1:1996
IEC60529:1989+A1:1999,
EN60529:1991+A1:2000 electrical equipment
Degree of Protection Provided by Enclosures
Water Ingress Testing (IP54)
EN ISO14155:2011
AAMI HE75:2009 human subjects - Good clinical practice
Human factors engineering guidelines and preferred practices for the design of medical devices
EN60601-1-1:2001
EN62304:2006 /AC:2008 processes
EN60601-1-6:2010
EN62366:2008 engineering to medical devices
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Item Standard
Defibrillator
IEC60601-1-11:2010
EN60601-1-11:2010
Description
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Evaluation and testing within a risk management process
EN ISO10993-1:2009
/AC:2010
EN ISO10993-5:2009
ISO10993-10:2010
EN ISO10993-10:
2010
Tests for in vitro cytotoxicity
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
RTCA/ DO-160G
Medical vehicles and their equipment – Air ambulances – Part1: Requirements for medical devices used in air ambulances.
Environmental Conditions and Test Procedures
IEC60601-2-4:2002
EN60601-2-4:2003
AAMI DF80:2003 for Airborne Equipment
Safety of cardiac defibrillators
Safety of cardiac defibrillators (including automated external defibrillators)
Package
EN60601-1-2:2007
/AC:2010
IEC61000-4-2:2008
EN61000-4-2:2009
IEC61000-4-3:2006
+A1:2007 +A2:2010
EN61000-4-3:2006
+A1:2008 +A2:2010
IEC61000-4-8:2009
EN61000-4-8:2010
CISPR11:2009+A1:2010
EN55011: 2009 +A1:2010
Electrostatic discharge (ESD) Ed.2.0
Radiated RF electromagnetic field Ed.3.1
Power frequency (50/60Hz) Magnetic field Ed.2.0
Limits and methods of measurement of radio disturbance characteristics of industrial scientific and medical (ISM) radio-frequency equipment
RF emissions, Group 1, Class B
Pre-Shipment test procedures (Package) ISTA (Procedure 1A,
2001)
ASTM D4169:2009
Reliability IEC60068-1:1988
+A1:1992
EN 60068-1:1994
Standard practice for performance testing of shipping containers and system
Environmental testing, Part1: General guidelines
EN60068-2-27:2009
EN60068-2-6:2008
EN60068-2-64:2008 random (digital control) and guidance
41
Item Standard
Labeling
Marking
Others
EN60068-2-31:2008
EN1041:2008
IEC /TR60878:2003
EN980:2008
ISO15223-1:2012
ISO15223-2:2010
Description
Rough handling shocks, primarily for equipmenttype specimens
Information supplied by the manufacturer with medical devices
Graphical symbols for electrical equipment in medical practice
Graphical symbols for use in the labeling of medical devices
Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
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 accordance with article II (2) of directive
2002/96/EC (WEEE)
With respect to electric shock, fire and mechanical hazards only in accordance with UL60601-1 AND CAN/CSA C22.2 NO.601.1 ADDITIONAL IEC60601-2-4
42
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 other than those specified may result in increased emission and/or decreased immunity of the AED.
The AED is suitable for use in the specified electromagnetic environment. The customer and/or user of the AED should assure that it is used in an electromagnetic environment as described below
;
Table 4. Electromagnetic Emissions (IEC60601-1-2)
Emission Test
RF emission
CISPR 11
RF emissions
CISPR 11
Compliance
Group 1
Class B
Electromagnetic Environment
The AED must emit electromagnetic energy in order to perform its intended function.
Nearby electronic equipment may be affected.
The AED is suitable for use in all establishments.
Power frequency
(50/ 60 Hz) magnetic field
IEC 61000-4-8
Table 5. Electromagnetic Immunity (IEC60601-1-2)
Immunity Test IEC60601-1-2
Electrostatic discharge (ESD)
IEC 61000-4-2
Test Level
±6 kV contact
±8 kV air
80 A/m
Compliance
Level
±6 kV contact
±8 kV air
80 A/m
Electromagnetic
Environment Guidance
Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least
30 %.
It may be necessary to position the AED further from the sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.
43
Table 6. Electromagnetic Immunity (IEC60601-1-2) (continued)
Immunity
Radiated RF
IEC 61000-4-3
IEC60601
10 V/m, 20 V/m
80 MHz ~ 2.5 GHz
(These values are set in accordance with IEC60601-2-4)
Compliance
Test test level level 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 such an environment.
10 V/m, 20V/m
Electromagnetic
Potable and mobile RF communications equipment should be used no closer to any part of the AED including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.
Recommend separation distance
d
= 1.2 √P 80 MHz to 800 MHz
d
= 2.3 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters as deter-mined by an electromagnetic site survey,
a
should be less than the compliance level in each
b
frequency range.
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 from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AED is used exceeds the applicable RF compliance level above, the AED should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
AED.
b
Over the frequency range 80 MHz to 2.5 GHz, field strengths should be less than 10 V/m
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the AED. (IEC60601-1-2)
44
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 help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AED as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Separation distance according to frequency of transmitter in meter
Transmitter in watt
80 MHz to 800 MHz
d
= 1.2 √P
0.01 0.12
800 MHz to 2.5GHz
d
= 2.3 √P
0.23
0.1 0.38
1 1.2
0.73
2.3
10 3.8
100 12
7.3
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.
Note: At 80MHz and 800MHz, the separation distance for 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.
Cables and Sensors
Pads cable
Table 8. Cables (IEC60601-1-2)
Maximum
Length
Complies with
1.7 m
-RF emissions, CISPR 11, Class B/ Group 1
-Electrostatic discharge (ESD), IEC 61000-4-2
-Radiated RF, IEC 61000-4-3
-Power frequency Magnetic field, IEC 61000-4-8
45
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Key Features
- Easy to use - The AED is designed to be used by laypeople, and it provides clear and concise instructions on how to use it.
- Compact and portable - The AED is compact and portable, making it easy to transport and store.
- Durable - The AED is durable and can withstand harsh conditions.
- Reliable - The AED is reliable and has been tested to meet strict standards.
- Versatile - The AED is versatile and can be used in a variety of settings, including schools, offices, and public places.
- Affordable - The AED is affordable and is a valuable investment for any organization.
