Mediana hearton aed a10 Operator's Manual
  1. Manuals
  2. Brands
  3. Mediana Manuals
  4. Medical Equipment
  5. hearton aed a10
  6. Operator's manual

Mediana hearton aed a10 Operator's Manual

Automated external defibrillator
Hide thumbs
Table of Contents

Advertisement

Quick Links

MEDIANA
HEARTON
AED A10
OPERATOR'S MANUAL
OPERATOR'S MANUAL
HeartOn A10
HeartOn A15
Automated External Defibrillator
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.
®
®

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the hearton aed a10 and is the answer not in the manual?

Questions and answers

Related Manuals for Mediana hearton aed a10

Summary of Contents for Mediana hearton aed a10

  • Page 1 MEDIANA HEARTON AED A10 OPERATOR’S MANUAL OPERATOR’S MANUAL ® HeartOn A10 ® HeartOn A15 Automated External Defibrillator 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.
  • Page 2 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.

  • Page 3: Table Of Contents

    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 ........................
  • Page 4   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.

  • Page 5: Safety Information

    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.
  • Page 6   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.

  • Page 7: Cautions

    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.
  • Page 8   This page is intentionally left blank.

  • Page 9: Introduction

    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).

  • Page 10: Training

    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.

  • Page 11: Description Of The Aed

    DESCRIPTION OF THE AED Top and Right Panel Components Figure 1. Top and Right Panel Components Cover shields the LED indicator, the power on/off button, the Cover speaker, the shock button. Status indicator displays the unit status and the battery status. Status indicator Pad connector links the pads.

  • Page 12: Bottom Panel Components

    Bottom Panel Components Battery pack Figure 2. Bottom Panel Components Rear Panel Components Handle Figure 3. Rear Panel Components...

  • Page 13: Symbols And Labels

    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 use...
  • Page 14 This page is intentionally left blank.

  • Page 15: Setting Up The Aed

    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.

  • Page 16: Soft Carry Case

    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.

  • Page 17: Setting Up The Aed

    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.
  • Page 18 This page is intentionally left blank.

  • Page 19: Battery Operation

    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.

  • Page 20: Battery Status Indication

    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.

  • Page 21: Self Test

    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.
  • Page 22 This page is intentionally left blank.

  • Page 23: Using The Aed

    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.

  • Page 24: 2010 Cpr Guidelines

    2010 CPR GUIDELINES Person not responsive? No signs of life? Address person and shake on shoulder! Perform the CPR Engage other people to help you and alternate CPR! Call for help, get AED Open the airway. Check for breathing! Note: “Open the airway, check for breathing” is removed from the CPR Open the airway, Check for sequence for assessment of breathing after opening the airway breathing.

  • Page 25: Operating The Aed

    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.

  • Page 26: Figure 5. Action Icon - Step 1

    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 ...

  • Page 27: Figure 9. Action Icon - Step 5

    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.

  • Page 28: Figure 12. Action Icon - 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.

  • Page 29: Aha 2010 Configuration

    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...

  • Page 30: Note User And Bystander Safety

    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.

  • Page 31: Maintenance

    If the AED is operated in out-of- range 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.

  • Page 32: Recycling And Disposal

    “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.

  • Page 33: Cleaning

    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.

  • Page 34: The Aed Maintenance

    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.

  • Page 35: Troubleshooting

    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. (info@mediana.co.kr).

  • Page 36: Emi (Electromagnetic Interference)

    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.

  • Page 37: Glossary

    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.
  • Page 38 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.

  • Page 39: Specification

    SPECIFICATION Defibrillation Electric Shock Biphasic Truncated Exponential (BTE) waveform Waveform (impedance compensation) Adult: 185 to 200J (±5%) Energy Pediatric: 45 to 50J (±5%) Operating mode Semi-Auto Lead II (RA, LL) Patient impedance 25 to 175 ohm Heart Rate 20 to 300 per min Accuracy 1 per min more than 200 µV...

  • Page 40: Environmental Conditions

    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...
  • Page 41 Accessories Specifications Pads Adult Pads Standby life 2 years from manufacture date Electrodes Disposable pads Placement Anterior-lateral Active gel area 96.25 cm Cable length 1.7 m Pediatric Pads (Option) Standby life 2 years from manufacture date Electrodes Disposable pads Placement Anterior-posterior Active gel area 69.53 cm...
  • Page 42 Defibrillation Defibrillation waveform Waveform Waveform parameters are automatically adjusted as a parameters 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 is the peak current, and I the final current.
  • Page 43 ECG Analysis Performance Rhythm class ECG analysis performance Shockable rhythm, Complies with IEC60601-2-4:2002 Ventricular Fibrillation (sensitivity > 90%) Shockable rhythm, Complies with IEC60601-2-4:2002 Ventricular (sensitivity > 75%) Tachycardia Non-Shockable Complies with IEC60601-2-4:2002 rhythm (specificity > 95%) Database for ECG Analysis ...

  • Page 44: Compliance

    Compliance Item Standard Description Classification IEC60601-1:1988 Internally powered (on battery power) +A1:1991+A2:1995, EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996 Type of IEC60601-1:1988 Type CF – Applied part protection +A1:1991+A2:1995, EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996 Mode of IEC60601-1:1988 Continuous operation +A1:1991+A2:1995, EN 60601-1:1990 +A1:1993 +A2:1995 +A13:1996 Degree of...
  • Page 45 Item Standard Description IEC60601-1-11:2010 Requirements for medical electrical equipment EN60601-1-11:2010 and medical electrical systems used in the home healthcare environment ISO10993-1:2009 Biological evaluation of medical devices – Part 1: EN ISO10993-1:2009 Evaluation and testing within a risk management /AC:2010 process ISO10993-5:2009 Biological evaluation of medical devices –...
  • Page 46 Item Standard Description EN60068-2-31:2008 Rough handling shocks, primarily for equipment- type specimens EN1041:2008 Information supplied by the manufacturer with Labeling medical devices Graphical symbols for electrical equipment in Marking IEC /TR60878:2003 medical practice Graphical symbols for use in the labeling of EN980:2008 medical devices Medical devices - Symbols to be used with...

  • Page 47: 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.

  • Page 48: Table 6. Electromagnetic Immunity (Iec60601-1-2) (Continued)

    Table 6. Electromagnetic Immunity (IEC60601-1-2) (continued) Immunity IEC60601 Compliance Electromagnetic 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. Potable and mobile RF communications equipment should be used no closer to any...

  • Page 49: Table 7. Recommended Separation Distances

    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.

This manual is also suitable for:

Hearton aed a15

Table of Contents

Save PDF