RADIANQBIO HR-501 User Manual
  1. Manuals
  2. Brands
  3. RADIANQBIO Manuals
  4. Medical Equipment
  5. HR-501
  6. User manual

RADIANQBIO HR-501 User Manual

Automated external defibrillator
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Automated External Defibrillator
User manual
Rev. 2.4.4

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the HR-501 and is the answer not in the manual?

Questions and answers

Summary of Contents for RADIANQBIO HR-501

  • Page 1 Automated External Defibrillator User manual Rev. 2.4.4...
  • Page 2  Contents of the manual may be changed without prior notification or agreement by RADIANQBIO  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 RADIANQBIO to follow up with the international standards update Symbol Explanation...
  • Page 5 Symbol Explanation Symbol Explanation WEEE Direct Current, DC Waste Electronic Direct Current. Electrical Equipment Separate collection for waste electrical and electronic equipment Battery Type Temperature Limit Lithium manganese Product/Part shall be oxide Battery kept at marked temperature range EC Representative Serial Number European authorized representative...
  • Page 6 Symbol Explanation Symbol Explanation Date of Manufacture Manufacture Name and address of manufacturer 4 digits of the year and 2 digits of month and day which indicate the manufacturing date Bluetooth LATEX Free AED supports Bluetooth wireless communication Power Button Electric Shock Press the button to Button...

  • 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 • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the HR-501, including cables specified by the manufacturer.
  • Page 9 Do not use battery not provided by RADIANQBIO RADIANQBIO is not responsible for damage/malfunction in operation caused by unofficial battery use. Uses of unofficial battery may cause serious damage / malfunction on AED Attach the AED pads clearly on the patient’s bare chest For accurate ECG analysis and proper electric shock delivery, AED pads shall be attached on the patient’s bare...
  • Page 10 • 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 Do not modify •...

  • Page 11: Limited Warranty

    3.2.7 Products that warranty period is expired 3.2.8 Un-registered AED 3.3 Warranty period 3.3.1 HR-501 (Main Body, excluding battery and AED pads)  5 years from date of manufacture (indicated on product label) 3.3.2 Battery (BT-303R)  4 years from date of manufacture (indicated on product label) 3.3.3 AED Pads (P-303)

  • Page 12: Product Repair/Exchange

    An inspection can be performed by RADIANQBIO (or regional representative) to check the warranty period and trace the defect. Once RADIANQBIO confirm the defect is caused by one of the manufacturing, development or delivery procedure, repair/exchange may be provided without any shipping charge.

  • Page 13: Product Introduction

    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 Semi-Automated External Defibrillator. The AED automatically analysis patient’s ECG and identifies and advise electric shock if it is necessary. Nearly every procedure for AED operation is guided through voice message and beep sound, as well as the visual guidance with picture description with LED.
  • 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 Auto/Manual Diagnosis power, 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 Output Range 150J±10% (Adult) / 50J±10% (Child)
  • Page 16 / exchange will be charged) Shelf Life : Single use only, 2 years for the shipping date BT-303R, HR-501 Battery Model : BT-303R Usage ; Electric power supply to AED Type : LiMnO2 (DC 12V 4.2Ah)

  • Page 17: Intended Use Including Intended User And Patients

    8 years of age or up to 25 kg when used with the child mode). Heart Guardian HR-501 may be used for both adult and child with the identical pads by separate button setting. Initial default setting is adult mode.

  • Page 18: Getting Started

    For a brief operation training, refer to quick guide provided with the product 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.radianqbio.co.kr’ for downloading HR-501 AED P-303 AED Pads III.
  • Page 19 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)
  • Page 20 4.3.2.3 Prepare the patient for AED operation 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 Take the AED pads out Remove the covering package ① ② and tear off the covering stickers Attach the pads to adult patient’s Connect the pads to AED ③ ④ chest and child patient’s chest or/and back 4.3.2.5 ECG Analysis Once AED pads are clearly attached to the patient’s chest and pads connector is connected to AED, AED starts ECG analysis for patient During ECG analysis, stay away from patient...
  • Page 22 Once ECG analysis is completed, the AED operates as shown below  In case of Electric Shock is needed (Defibrillation is required) ① Audio guidance: ‘Electric shocks are needed” ② After a while, once recharging is completed, shock button blinks. ③...
  • Page 23 ② Audio guidance: ‘If there’s no pulse, please start CPR immediately’ During AED conducts CPR guide, no ECG analysis is proceeded. Once CPR guidance completed, the product informs the rescue progress status via audio message and re-analyzes ECG.  Other conditions In case of AED pads’...

  • Page 24: Guidance For Maintenance

    5.1 AED location and periodical maintenance 5.1.1 Please set AED at a place where AED can be easily found and accessed. RADIANQBIO 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 25  If sealing package of AED pads is ripped or damaged, do not use the pads and replace it to new one  HR-501 only accepts P-303 AED pads, do not use any other AED pads not provided by RADIANQBIO. This model (P-303) can only be used in conjunction with Heart Guardian HR-501.

  • 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 Shelf Life is expired (2 years from shipping date), RADIANQBIO suggests replacing the battery to new one. Suggested battery Shelf Life is 4 years in standby mode 5.3 Cleaning...

  • Page 27: Self-Diagnosis

    6.1 Self-diagnosis Every time when power button is pressed Power-On Self-test Flash ROM test (Operation mode) Charge/Discharge test Battery Output level test Automatically performed once per month on 1 Regular Self-test Flash ROM test (Stand-by mode) Charge/Discharge test Battery Output level test If the product fails in self-diagnosis test, status light blinks in red and beeper sounds a warning.
  • Page 28 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 Guides user current CPR procedure...

  • Page 29: Troubleshooting

    Do not attempt to disassemble or repair the AED arbitrarily Do not attempt to disassemble the AED arbitrarily due to danger of electric shock hazard when high voltage is recharged. RADIANQBIO is not responsible for electric shock resulted from unauthorized disassembly or attempt to...

  • 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 Operating 0 ~ 50℃ (32 ~ 122℉) * Temperature range Shipping/transporting (within 5days) -20℃...

  • Page 31: Functionality

    7.3 Functionality Parameter Detail The AED FFT ECG analysis system automatically FFT ECG Analysis analyzes the patient’s ECG and advises you when defibrillation is required Waveform Biphasic Truncated Exponential (BTE) Impedance range 25Ω to 175Ω Adult mode: 150J±10% Electric shock energy Child mode: 50J±10% Since the initiation of AED operation (Power On), Charge time...

  • Page 32: Applicable Standards

    7.4 Applicable standards Type Detail General KGMP by KCL IEC60601-1 (Basic safety & essential performance) Safety and performance Type BF – Applied part IEC60601-2-4, EN 1041, ISO 15223-1 Shock IEC60068-2-27 Vibration IEC60068-2-64 (10Hz to 2,000Hz) Free fall drop IEC60068-2-32 (1m) Enclosure IEC 60529, IP55 (Particle and water ingress)

  • Page 33: Parameters For Bt-303R (Battery)

    7.6 Parameters for BT-303R (Battery) Parameter Detail Type Lithium Manganese Dioxide (LiMnO Output Voltage 12 VDC 4.2Ah Disposal Abide by regional/national regulations 4 years for standby mode Shelf Life (can be reduced by temperature condition) 7.7 FFT ECG Analysis FFT ECG Analysis algorithm is for efficient and accurate ECG detection algorithm that meets below requirements and recommendations •...

  • Page 34: Guidance And Manufacturer's Declaration

    Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 , The HR-501 uses RF energy only for its internal function. (EN 55011) Class B Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 35 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 HR-501 is used exceeds the applicable RF compliance level above, the HR-501 should be observed to verify normal operation. If abnormal performance is observed additional measures may be necessary, such as reorienting or relocating the HR-501.
  • Page 36 164-0010211-007...

Table of Contents