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RADIANQBIO HR-501 User Manual Download Page 32

31 

 

7.4

 

Applicable standards 

Type 

Detail 

General 

KGMP by KCL 

Safety and performance 

IEC60601-1 (Basic safety & essential 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 
(Particle and water ingress) 

IEC 60529, IP55 

EMC 

IEC60601-1-2CEMC (EMC) 
Directive 2014/30/EU   

 

7.5

 

Parameters for P-303 (AED Pads) 

Parameter 

Detail 

Type 

Pre-gelled, self-adhesive, disposable, non-polarized 
defibrillation pads, Common use for adult and child 
both, Non-sterilization 

Shelf Life 

2 years from date of shipment 

Location to attach pads 

.Location of pads for adult : chest   
.Location of pads for child : chest or/and back   

Pad size and length 

Size: 110 x 120 mm, cable length: 1.8 m 

Pouch size 

170 mm * 250 mm 

Disposal 

Abide by regional/national regulations 

 

Summary of Contents for HR-501

Page 1: ...Automated External Defibrillator User manual Rev 2 4 4...

Page 2: ...ided with the original manual carefully for quick and adequate product operation Contents of the manual may be changed without prior notification or agreement by RADIANQBIO Data without any quotation...

Page 3: ...er and patients 4 2 Getting started 4 3 Guidance for maintenance Chapter 5 AED location and periodical maintenance 5 1 After first time use 5 2 Cleaning 5 3 Troubleshooting Chapter 6 Self diagnosis 6...

Page 4: ...alfunction Reference Additional reference data is referred or Dangerous Voltage The defibrillator output has high voltage and may present a shock hazard Additional info Additional information is descr...

Page 5: ...C Representative European authorized representative Serial Number LOT Batch code Product Model Number Do not use if package is damaged Single time use only Do not reuse AED pads Protection Level Prote...

Page 6: ...shock button when it is needed Adult Child mode switch Confirm Adult Child mode switch prior to AED pads attachment i button Self diagnosis for system check up First Aid Safety messages for emergency...

Page 7: ...ric shock to patient In child mode about 50J of electric shock is set to be delivered if patient is under the age of 7 or weighting below 25 kg please set Child Mode by moving Adult child mode switch...

Page 8: ...local national sales representative for repair or replacement Electromagnetic emissions and equipment adjacent Use of this equipment adjacent to or stacked with other equipment should be avoided beca...

Page 9: ...agnostic process that may cause increased analysis time or result analysis error Avoid contact with the patient while analysis is on progress AED pads are single use only Do not reuse AED pads This po...

Page 10: ...ry 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...

Page 11: ...improper operation not following the user manual 3 2 2 Defect caused by unauthorized repair or modification 3 2 3 Defect caused by external shock including drop 3 2 4 Defect caused by natural disaste...

Page 12: ...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 Shipping will be comp...

Page 13: ...ng 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 E...

Page 14: ...y Provides electrics to AED G AED Pad Connector Connect the AED pads prior to attaching the pads to patient H Shock Button Press the button when guidance indicates to deliver charged electric shock to...

Page 15: ...0J 10 Child Data Storage 100 times of ECG log can be recorded Control Button Power Analysis Shock Adult child mode switch Battery Type BT 303R LiMnO2 12V DC 4 2Ah Number of shock At least 200 times Ne...

Page 16: ...by user s mistake repair 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...

Page 17: ...e used for both adult and child with the identical pads by separate button setting Initial default setting is adult mode It is highly recommended for every potential user to complete periodic training...

Page 18: ...g defibrillation shock Interaction with pacemakers Skin burns around the electrode placement area Allergic dermatitis due to sensitivity to materials used in electrode construction and Minor skin rash...

Page 19: ...s 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 25 kg Child Mode Below age of 7 o...

Page 20: ...AED pads attachment 4 3 2 4 Attach AED Pads to the patient and connect pads to AED Saving time is very important for sudden cardiac arrest patient Time shall not be wasted on taking off the clothes R...

Page 21: ...r and back Connect the pads to AED 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 4 3 2 6 Ele...

Page 22: ...Start CPR Audio guidance Compress the chest 30 times Beeper rings 30 times Audio guidance Start mouth to mouth CPR 2 times CPR guidance for will repeat every 30 seconds and operates as shown below aft...

Page 23: ...h the pads to the patient s bare skin Even though electric energy charge is completed if user does not push blinking shock button for more than 15 seconds AED will conduct discharge the electric energ...

Page 24: ...ure Range 0 to 50 32 to 122 Humidity 5 to 95 non condensing Stored temperature range of Shipping transporting within 5days Temperature Range 20 to 60 4 to 140 Humidity 5 to 95 non condensing Avoid AED...

Page 25: ...n 10m Do not use battery not provided by RADIANQBIO RADIANQBIO is not responsible for damage malfunction in product operation caused by use of unofficial battery Since use of unofficial battery may ca...

Page 26: ...ctric 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...

Page 27: ...ut level test If the product fails in self diagnosis test status light blinks in red and beeper sounds a warning In this state the product does not operate properly If the product does not operate pro...

Page 28: ...sounds Min Prompts when error is found during operation Status Indication Light Green Blink Prompts AED to conduct self diagnosis test Status Indication Light Off Maintenance manager mode Procedure L...

Page 29: ...Operating Status Indication light Red blink Audio message The battery is low please change the battery immediately Replace the battery to new one Audio message System error 000X Contact the vender fo...

Page 30: ...ht Including battery 2 2kg 7 2 Environmental parameters Parameter Condition Detail Temperature range Operating Shipping transporting within 5days 0 50 32 122 20 to 60 4 to 140 Humidity 5 95 non conden...

Page 31: ...a new fully charged battery with low on battery the charge time gets significantly longer Operating time For a new fully charged battery pack at 20 30 C 200 discharges at maximum energy or 10 hours o...

Page 32: ...EC 60529 IP55 EMC IEC60601 1 2CEMC EMC Directive 2014 30 EU 7 5 Parameters for P 303 AED Pads Parameter Detail Type Pre gelled self adhesive disposable non polarized defibrillation pads Common use for...

Page 33: ...01 2 4 AHA s recommend 90 Shockable Rhythm VT IEC 60601 2 4 AHA s recommend 75 Non shockable Rhythm NSR IEC 60601 2 4 AHA s recommend 99 Non shockable Asystole IEC 60601 2 4 AHA s recommend 95 Non sho...

Page 34: ...he user if conditions are not ideal No other ESD requirements are necessary Electrical fast transient burst IEC 61000 4 4 2 kV for power line supply lines 1 kV for input output lines 100 kHz repetitio...

Page 35: ...structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to...

Page 36: ...164 0010211 007...

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