Radian Heart Guardian AED User Manual
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Radian Heart Guardian AED User Manual

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HR-501 operation Manual Rev.1.1
Rev. 2016/02/12
HR-501
Heart Guardian AED User Manual

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Summary of Contents for Radian Heart Guardian AED

  • Page 1 HR-501 operation Manual Rev.1.1 Rev. 2016/02/12 HR-501 Heart Guardian AED User Manual...
  • Page 2  Contents of the manual may be changed without prior notification or agreement by Radian  Data without any quotation mark may be different from estimated data as compared to actual data...

  • Page 3: Table Of Contents

    Contents Symbol Descriptions ............ Chapter 1 Warning and Caution ..........Chapter 2 Limited Warranty ............Chapter 3 Customer Requirement and product registration ......3.1 Warranty details ................3.2 Warranty period ................3.3 Product repair/exchange ..............3.4 Product Introduction ........... Chapter 4 Product overview ................

  • Page 4: Symbol Descriptions

    Following symbols refer to the international standard, and are indicated on the surface of the product, battery, AED pads, and packing box  Some symbols can be changed/modified/added by RADIAN to follow up with the international standards update Symbol Explanation...
  • Page 5 Symbol Explanation Symbol Explanation Keep away from Do not expose or ignition materials incinerate to open Do not operate or keep flame AED around ignition materials Expiration date Do not expose to AED pads shall be sunlight replaced after marked Do not expose to direct date sunlight...
  • Page 6 Symbol Explanation Symbol Explanation Protection Level Maintenance Protection level that required shows anti-dust and waterproof level Recycling CE Mark This equipment Dispose of properly conforms to in accordance with essential all state, province, requirements of the and country Medical Device regulations Directive 93/42/EEC...

  • Page 7: Warning And Caution

    2 Warning and Caution  Please refer to the following for safety use of HR-501  Certain contents may be indicated delicately in other part Do not use if the patient shows any reaction or is consciousness HR-501 is a portable defibrillator manufactured for ventricular fibrillation patients.
  • Page 8 Do not attempt to disassemble or repair the AED Disassembling AED may result electric shock hazard. RADIAN is not responsible for electric shock hazard resulted by unauthorized disassemble or repair. Please contact local/national sales representative for repair or replacement...
  • Page 9 1 hour of storage at 20℃~ 30℃ temperature condition prior to actual AED operation. For long-term storage(over 5 days), RADIAN recommends maintaining AED with temperature range from 20℃ to 30℃. AED pads and battery may have significant performance degrade with the long-term storage(over 5 days) at out of range of 0℃~40℃...
  • Page 10 The AED requires periodic maintenance for followings: • Status indication light check • Battery manufacturing date check • AED pads expiration date check Do not use AED for CPR training, experiment, and demo HR-501 is only used for sudden cardiac arrest patient. Any HR-501 operation on a simulator or a mannequin may cause serious malfunction or damage on AED Compliance with national and regional regulation...

  • Page 11: Limited Warranty

    AED pads but varies the covering time periods) that guarantees free replacement and repair service. Warranties and returning policies may vary by products and periods depends on regional regulations and RADIAN’s sales policy. Please contact sales representatives for more details.

  • Page 12: Product Repair/Exchange

    3.4 Product repair/exchange An inspection can be performed by Radian (or regional representative) to check the warranty period and trace the defect. Once Radian confirm the defect is caused by one of the manufacturing, development or delivery procedure, repair/exchange may be provided without any shipping charge. Shipping will be completed within maximum of 50 days from the day the product arrives at RADIAN Corp., which are automatically added up to remaining warranty...

  • Page 13: Product Introduction

    4 Product introduction Please consult the quick manual and user manual prior to AED operation It is highly recommended for every potential user to complete periodic training for CPR and HR-501 operation. Please contact national/local representative for Heart Guardian series to find out detailed CPR and AED operating training schedule 4.1 Product overview HR-501, a portable electric device operated by battery power, is an easy-to-use...
  • Page 14 ○ Power Button Used to turn on or off the product ○ Summarized Instruction Simple Instruction for CPR and AED use LED light informs about product status to ○ Status indication light user by blinking to various color ○ Handle For carrying AED safely Prevents external substances exposure to ○...
  • Page 15 4.1.2 Specification Product Type Semi-automated External Defibrillator Automatic diagnosis (battery power, circuit power, Auto/Manual Diagnosis button operation checks) ECG complete analysis FFT ECG Analysis Step by Step Audio Voice record (English) Guidance Compatible Adult/Child Adult/child mode switch (default) Charge Method Hi-Cap charge 150J±10% (Adult) / 50J±10% (Child) Output Range...
  • Page 16 4.1.3 Accessories HR-B1 (Portable AED case) Model : HR-B1 Usage ; Storage and protection Type : Plastic, Artificial Leather Size : 235(W) x 330(H) x 95(T)mm Weight : 370g Life time : 1 year(Portable) 10 years(Storage) P-303, AED Pads Model : P-303 Usage ;...

  • Page 17: Indications Of Use

    4.2 Indications of use It is highly recommended for every potential user to complete periodic training for CPR and HR-501 operation. Please contact national/local representative for Heart Guardian series to find out detailed CPR and AED operating training schedule Heart Guardian, HR-501 is an emergency medical device used for patient stops in breathing lapsed into unconsciousness due to sudden cardiac arrest No response Unusual or no breath...

  • Page 18: Getting Started

    4.3.1 Preparation ① Open the packing box and confirm product components. If the components are not prepared, inquiry contact national/local representative. Manual and quick guide is available at ‘www.radian.co.kr’ for downloading HR-501 AED HR-501 User Manual III.

  • Page 19: Aed Operation

    4.3.2 AED Operation 4.3.2.1 Open the cover and set up the adult/child mode switch Heart Guardian, HR-501 may be used for both adult and child. If it is hard to define the patient’s weight and age quickly, proceed further operation procedure with the default mode (adult mode) Adult Mode Above age of 8 or Minimum weight 25kg Child Mode...
  • Page 20 AED shall be placed just next to the patient, and remove clothing from the patient chest, and make sure the patient’s chest is clean and dry. Shaving hair may be necessary for better AED pads attachment Saving time is very important for sudden cardiac arrest patient Time shall not be wasted on taking off the clothes.
  • Page 21 During ECG analysis, stay away from patient For accurate and safe ECG analysis, during ECG analysis, do not physically contact the patient 4.3.2.6 Electric shock and CPR Once ECG analysis is completed, the AED operates as shown below  In case of Electric Shock is needed (Defibrillation is required) ①...
  • Page 22 Be careful of electric shock Electric shock may be delivered to a person who is physically contacting with the patient. Before pushing the shock button, confirm and instruct others to stay away from the patient  Electric shock is not needed ①...

  • Page 23: Data Management

    5.1 AED location and periodical maintenance 5.1.1 Please set AED at a place where AED can be easily detected and accessed. RADIAN strongly suggests setting AED close to a telephone in order to call emergency aid service immediately in case of emergency 5.1.2 All components including P-303 electric pads shall be kept together...
  • Page 24  Temperature Range: 0 ~ 40℃ (32 ~ 104F)  Humidity Range: 5% ~ 95% (No saturated place) ④ Avoid AED storage in below places  Place where wide temperature changes happen frequently  Place where is exposed to direct sunlight ...
  • Page 25  In the presence of hyperbaric oxygen tank (within 10m)  In the presence of hydrogen tank (within 10m) Do not use battery not provided by RADIAN RADIAN is not responsible for damage/malfunction in product operation caused by use of unofficial battery. Since use of unofficial battery may cause trouble/malfunction ②...

  • Page 26: After First-Time Use

     If AED pads were used or unpacked, please replace the pads to new ones  If AED delivered electric shocks at least over 3 times, and life time is expired (2 years from manufacturing date), RADIAN suggests replacing the battery to new one. Suggested battery life is 4 years for standby mode 6 Troubleshooting 6.1 Self-diagnosis...

  • Page 27: Aed Conditional Alarm

    6.2 AED conditional alarm Alarming Indication Description Status Indication Light Prompts the state of proper use Blue Blink Status Indication Light Red Blink Prompts when error is found during operation 3 beep sounds/Min Status Indication Light Prompts AED to conduct self-diagnosis test Green Blink Status Indication Light Maintenance manager mode...

  • Page 28: Troubleshooting

    6.3 Troubleshooting Mode Alarming Indication Situation To do AED is turned off after 8 to 10 times of electric Replace the battery shock or 10min later to new one since power-on Status Indication light: Audio message: Red blink The battery is low, please Replace the battery change the battery to new one...
  • Page 29 Do not attempt to disassemble the AED arbitrarily due to danger of electric shock hazard when high voltage is recharged. RADIAN is not responsible for electric shock resulted from unauthorized disassembly or attempt to repair. Please contact sales representative for defective...

  • Page 30: Technical Data

    7 Technical data 7.1 Physical parameters Parameter Detail Operation Semi-automatic external defibrillator Dimensions 223(W) x 312(L) x 85(H)mm Weight (Including battery) 2.2kg 7.2 Environmental parameters Parameter Condition Detail Short-term storage* 0 ~ 40℃ (32 ~ 104℉) (under 5 days) Temperature range Long-term storage 20 ~ 30℃...
  • Page 31 Waveform Biphasic Truncated Exponential (BTE) 25Ω to 175Ω Impedance range Adult mode: 150J±10% Electric shock energy Child mode: 50J±10% Since the initiation of AED operation (Power On), Charge time 8 seconds with a new, fully charged battery; with low- on battery, the charge time gets significantly longer For a new, fully charged battery pack at 20~ 20°C: Operating time 200 discharges at maximum energy or 10 hours of...

  • Page 32: Applicable Standards

    7.4 Applicable standards Type Detail KGMP by KCL General (KCLAAB-140053) IEC60601-1H (Basic safety & essential performance) IEC60601-1-2CEMC (EMC) Safety and performance IEC60601-2-4:2011 EN 1041:2008 EN 980:2008 Shock IEC60068-2-27 Vibration IEC60068-2-64 (10Hz to 2,000Hz) Free fall drop IEC60068-2-32 (1m) Enclosure IEC 60529, IP54 (Particle and water ingress) IEC60601-1-2CEMC (EMC) •...

  • Page 33: Parameters For P-303(Aed Pads)

    7.5 Parameters for P-303 (AED Pads) Parameter Detail Pre-gelled, self-adhesive, disposable, non- Type polarized defibrillation pads Shelf life 2 years Disposal Abide by regional/national regulations 7.6 Parameters for BT-303 (Battery) Parameter Detail Lithium Manganese Dioxide (LiMnO Type Output Voltage 12 VDC 4.2Ah Disposal Abide by regional/national regulations 4 years from date of manufacture...
  • Page 36 #1610, Halla-Sigma Valley, 53, Gasan Digital 2-ro Geumcheon-gu Seoul, Korea +82-2-1670-1980 Info@radian.co.kr www.radian.co.kr...

This manual is also suitable for:

Hr-501

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