Radian HR-501 User manual

Heart Guardian HR-501 (Ver.2.3)
(Automated External Defibrillator)
Rev. 2015.03.10
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Always use after reading the user manual.
This user manual is keep users safety and to protect the damage on your property.
Do not lose user manual, Please keep a user manual to be able to see at any time.
Copyright © RADIAN Corp. All Rights Reserved
User Manual
Save that is better than anything
This product is a medical device tracking targets.

RM1610, SIGMA VALLEY, GASAN
DIGITAL 2-RO 53 GEUMCHEON-GU,
SEOUL 153-802 SOUTH KOREA
T E L : [phone]
F A X : [phone]
W e b : www.radian.co.kr
E_mail: [email protected]
Save that is better than anything
2HR-501 User Manual (Ver.2.3)
[phone]
A/S
CUSTOMER
SERVICE
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Users must refer to the quick manual provided with the original manual carefully
in case of actual emergency for quick and adequate product performance.
As a tracking medical device, HR-501 requires registration of installation place
and administrator. Online registration is available in RADIAN’s website.
Administrator of HR-501 must be well informed of the manual and display it at
a place visible for all users.
Contents of the manual may be changed without prior notification or agreement
by RADIAN
This manual may be referred to for other models.
Data without any quotation mark may be different from estimated data as
compared to actual data.
This manual cannot be distributed and copied without the consent of RADIAN.
RADIAN reserves all copyrights to this manual.
CAUTION

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Contents
READY USE MANAGEMENT OTHER
1. Symbol Descriptions
2. Safety Alert Descriptions
3. Limited Warranty
4. Product Introduction
4.1 Product description
4.1.1 Product overview
4.1.2 Product specification
4.1.3 Product accessories
4.2 Indications of users
4.3 Getting started
4.3.1 Preparation
4.3.2 Procedure of use
4.3.3 Data management
5. Guidance for Maintenance
5.1 Method of keeping once HR-501 is used
5.2 Product storage
5.3 Product maintenance and upgrades
6. Troubleshooting
6.1 Self-diagnosis
6.2 Condition verification
6.3 Troubleshooting
7. Technical Data
7.1 BTE (Biphasic Truncated Exponential) wave form
7.2 Audio guidance
8. Appendix
8.1 In accordance with all states, provinces, and country regulations
8.2 Emergency medical device declaration form
8.3 Emergency medical device registration form
8.4 Emergency medical device management report
8.5 AED check list
8.6 The entries
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READY USE / MANAGEMENT OTHER

4HR-501 User Manual (Ver.2.3)
1. Symbol Descriptions
The following symbols refer to the international standard, and are indicated
on the surface of the product, battery, AED pads, and packing box.
Some symbols may be altered depending on the international standard.
Some symbols may be added as needed without additional explanation.
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IP54
Symbol Explanation Symbol Explanation
Warning! This alert identifies
hazards that may cause serious
personal injury or death
Reference, additional
reference data
Disposable. Single patient
use only
Do not recharge battery
Additional information is
provided in the AED
The AED is protected against
the effects of splashing water
in accordance with EN 60529
Dispose of properly in
accordance with all state,
province, and country
regulations
Do not operate or keep
around ignition materials
Warning! This alert identifies
hazards that may cause an
electric shock, product
damage, and malfunction.
Dangerous Voltage:
The defibrillator output has
high voltage and may present
a shock hazard

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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
Bluetooth
Repair or Exchange
Shock Button
Serial Number
Power Button
Non Sterile
Use pads by this date
Defibrillator protected
by Type BF
Upper and lower operating
temperature limit
Not water proof
Date of manufacture:
year and month
Waste Electronic Electrical
Equipment (WEEE) Separate
collection for waste electrical
and electronic equipment
Symbol Explanation Symbol Explanation

6HR-501 User Manual (Ver.2.3)
2. Warning and Caution
Please refer to the following for safe use of HR-501.
Certain contents may be elaborated in detail elsewhere in the manual.
Warning: Do not use if the patient shows any reaction or is
consciousness
HR-501 is a portable defibrillator manufactured for
ventricular fibrillation patients. Before using the product,
it is very necessary to check the patient’s consciousness
and respiratory condition; do not use if the patient is
conscious and reacts.
Warning: The AED’s Basic Setting is Adult Mode.
In adult mode, it delivers 150J of electric shock to the
patient. In case of a child, only up to 50J of electric shock
is set to deliver. If patient is under the age of 7, weighting
below 25kg, set to child mode by using Adult/Child selection
button and place pads solidly to appropriate spot.
Shift Right Left shift
Adult Children / Infant
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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
Warning: Be Careful of Electric Shock
Electric shock may be delivered to a person who is in
physical contact with the patient. Before pushing the shock
button, confirm and instruct the person or others to stay
away from the patient. For safe usage, avoid the following
situations. Do not use under water. When the patient is
exposed to rain or snow, use after the patient is dry in a dry
area.
a. When the patient is in contact with metals, do not touch
the metals.
Warning: Do Not Use Around Flammable Materials
To avoid possible fire or explosion hazard, do not use
in the following situations/places.
a. In the presence of flammable gases
b. In the presence of hyperbaric oxygen tank (within 10m)
c. In the presence of hydrogen tank (within 10m)
d. In the presence of other miscellaneous explosive or
flammable materials

8HR-501 User Manual (Ver.2.3)
Warning: Do Not Use Battery Not Provided By RADIAN
RADIAN Inc. has no responsibility in errors of operation
due to the use of miscellaneous battery other than the official
battery. Non-official battery may cause trouble and malfunction.
So please use the official one.
Warning: Do Not Attempt to Recharge or Cause Heat/
Damage the Battery (BT-303
Recharge or heat/damage of battery (BT-303) may cause
an explosion or fire hazard. When the battery runs out,
exchange
with RADIAN Inc. or at a sales store.
Warning: Do Not Disassemble or Repair the AED Arbitrarily
Do not attempt to disassemble the AED arbitrarily as
doing so could cause electric shock accident when high
voltage is discharged. RADIAN Inc. is not responsible for
electric shock resulting from unauthorized disassembly or
attempt to repair. Please contact sales representative for
failure or defective AED.

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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
Warning: During Use of AED, Do Not Move the Patient
Moving the patient when using AED may cause error in
analyzing patient status; do not move patient if possible.
Warning: Place Pad Properly in Accordance with Guidance
Despite switched placement of pads, AED works properly.
However, an electric shock is improperly delivered unless
the pads are placed on the patient’s skin closely. Attach
the pads after removing any foreign substance between
patient’s skin and pads. When pad is not attached to skin
properly, check if surface of pads is dry. If surface of pads
is dry, then exchange with new pads
During ECG analysis, if anyone touches the body of the
patient, there may be an error in analysis result.
Warning: During ECG Analysis, Stay Away From the Patient
Exchange immediately if packing of electric pads is
damaged. In addition, in case of single use, if expiration
date (indicated on the exterior of wrapper) is over,
exchange with new one necessarily. Pads need to be kept
sealed.
Warning: Electric pads are single-use only with expiration
date included

10 HR-501 User Manual (Ver.2.3)
IP54
Since the AED is an electronic product, electromagnetic
intervention may affect product performance. At the moment
of product operation, minimize intervention by placing
the AED as far as possible from other electronic devices
that may bring about electromagnetic intervention or turn
off other electronic devices. The devices that may cause
electromagnetic intervention are cell phones, radiophones,
and X-ray equipment.
Warning: Use in No Electromagnetic Intervention Area
Battery and electric pads of HR-501 are designed to be
used from -20℃to 60℃but, in case of long-term storage,
it is encouraged to keep from 0℃~ 40℃. In case of electric
pads, there may be problem in product performance if
it conducted long-term use and storage out of range of
0℃~ 40℃.
Warning: Observation of Temperature Guideline for Stable
Operation
IP54 grade is not capable of blocking direct inflow of
liquid completely. In case of water or liquid inflow inside
the AED, there may be malfunction or failure of the AED.
Warning: Do not have the AED exposed to water or other
liquids directly
Operate in case of occurrence of sudden cardiac arrest
in patients only in order to prevent electric shock accident.
Moreover, use of the AED in a simulator or a manikin
may cause malfunction.
Warning: Do not Attempt to Use for the Purpose of Education,
Training, Experiment, and Demo