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

3
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

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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
The AED is designed for anyone to use with ease, but we
encourage the completion of advanced training for proper
use. (regarding national standard)
Warning: It is Recommended to Be Well-Informed of the
Method of Use and CPR in Advance.
Display the expiration dates specified on electric pads
and manufacturing date indicated on the surface of battery
on visible spots including storage box and surface of the
AED. Implement periodic management of parts’ life.
Warning: The AED Requires Periodic Maintenance Control
Maintenance control of the AED, and authorization and
responsibility of usage must be follow relevant national
and regional standards. For more details, please contact
sales store.
Reference: Compliance with National and Regional Standard
The AED, classified as an electronic device, according
to local guideline, needs to be disposed in a proper way.
Alternatively, it can be returned to the sales store.
Reference: Product Disposal
Reference: The AED is produced according to the CPR
and ECC 2010 Guidelines defined by the ERC and AHA.

12 HR-501 User Manual (Ver.2.3)
3. Warranty Details with Regard to the AED
Product registration of the purchased product is necessary
for application of the effective free guarantee. Product
registration may be done via telephone [phone]),
by product registration menu on website (www.radian.co.kr),
or sending a product registration form to RADIAN Inc.
HR-501, as a tracking medical device, needs to be registered
mandatorily specifying installed location and administrator.
Customer Requirement and Product Registration
RADIAN Inc. provides the purchaser of HR-501 with free
replacement service for internal product defect of parts
including battery and electric pads provided along with
HR-501. The warranty is not applicable to devices
transferred or traded. Despite occurrence of product
defect within warranty period, no warranty is valid in the
following cases.
Warranty Details
Failure caused by improper operation from not following
the manual.
Failure caused by repair or modification conducted out
of RADIAN.
Failure or damage caused by external shock including
dropping of device.
Failure caused by natural disasters such as fire,
earthquake, flood, and thunder stroke.
Case of damage due to use and storage in improper
environment such as high temperature and high humidity.
Failure of operation caused by exhaustion of parts
including battery.
Random alternation of purchase date, name of customer,
vender, and serial number.
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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
Warranty period is applied based on the following parts
standard. If the AED is used for commercial purpose,
warranty period will be reduced to no more than a half.
Warranty Period
In case of occurrence of internal product defect within
warranty period, no shipping and repair/exchange cost
will be charged. However, before shipping, it is highly
necessary to call customer service at [phone] for
shipping method. Shipping will be completed within a
maximum of 30 days from the day the product arrives at
RADIAN Inc., which is automatically added up to the
remaining warranty period.
Product Repair/Exchange
5 years from date of manufacture
HR-501 (Main Body) Excluding Battery and Electric Pads:
4 years from date of manufacture (indicated on product label)
Battery (BT-303):
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2 years from date of manufacture (indicated on the surface
of pads)
Electric Pads (P-303):
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A year from date of product delivery
Attached Equipments (AED case, AED cabinet):
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[phone]
A/S
CUSTOMER
SERVICE

14 HR-501 User Manual (Ver.2.3)
4. Product Introduction
Refer to quick manual provided with original manual carefully
in actual emergency for quick and adequate product
information.
It is highly recommended for every potential user to complete
periodic education of CPR and HR-501. RADIAN Inc.
conducts education of CPR and AED in accordance with
customer requests. For more information, visit RADIAN’s
website (www.radian.co.kr) and refer to the education
menu.
Heart Guardian, HR-501 as a portable device operated
by battery, is an easy-to-use Semi-automated External
Defibrillator. The AED identifies whether electric shock is
needed by automatically analyzing ECG of SCA (Sudden
Cardiac Arrest) and adjusts amount of electric shock
depending on physique by automatically analyzing the
patient’s body. From the moment the power is on, all the
steps to use start by audio guidance through voice message
and beep sound. At the same time, visual guidance operates
with picture description and LED. Heart Guardian, HR-501
is manufactured based on CPR guideline of AHA revised
in 2010.
4.1 Product Information

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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
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4.1.1 Product Overview
Power button
button
Status indication
light
Handle
CoverShock button
Pads connector
link Procedure Indication
Light
Adult /
Kid Switch

16 HR-501 User Manual (Ver.2.3)
F
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L
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- The button confirms product use information or notifies
error message
- Indication light informs about product status by various colors
-light or blinks
- The button is used to turn on or off the product
- Helps deliver product
- Protects product from foreign substances
- Explains method of equipment use
- Select Adult/Kid mode. Basic setting is ‘Adult’ mode
- Implements electric shock
- A link to connect pads connector to the product
- Announces the stage of current process in product use
- Send or receive data from a PC with Bluetooth connection
- Send or receive data via infrared light transmission port
- Speaker for audio guidance
Power button
button
Status indication
light
Handle
Cover
Summarized
Instruction
Adult /
Kid Switch
Shock button
Pads connector link
Procedure
Indication Light
Bluetooth Port
IrDA Port
Speaker
Adult /
Kid Switch
Speaker
IrDA Port
Bluetooth Port
Procedure
Indication Light
Summarize Instruction

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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
HR-501 (AED)
4.1.2 Product Specifications
Product Type
Auto/Manual
Diagnosis
ECG complete
analysis
Step by Step
Audio Guidance
Compatible
Adult/Kid
Charge method
Output range
Data save/send
Control button
Battery type
Number of shock
Pads type: P-303
Storage and
temperature in use
Product size
Product weight
Product quality
Product color
Basic components
- Low power heart defibrillator
- Automatic diagnosis
(battery power, circuit power, button operation check)
- NEWFM ECG Analysis
- Korean, Chinese, and English (dubbing record)
- Adult/Kid compatible switch (basic)
- HI-Cap charge
- 150J (Adult)/50J (Kid)
- 40 min (built-in memory), IrDA, Bluetooth 2.0
- Power, Analysis, Shock, Adult/Kid compatible switch
- BT-303: (LiMnO2, 12V DC 4.2A)
- AED electric pads (single-use), 2 lead wire (1.5m), 4-hole plug
- BT-303: more than 200 times
- 20c ~ 60c (within 5 days),0c ~ 40c (more than 5days)
- 230(W) x 320(L) x 85(H) mm
- 2.2kg (battery included; AED case and electric pads excluded)
- Plastic (surface), Rubber (Handle)
- Red (basic feature)
- AED case, Electric pads (PT-303), Battery (BT-303), Product
-manual, Quick guide

18 HR-501 User Manual (Ver.2.3)
Name of model
Purpose of use
Case type
Product size
Product weight
Free warranty
- HR-B1
- Storage and protection of AED from foreign
-substances, storage of pads and manual
- Plastic, artificial leather
- 60(W) x 175(H) x 25(T)
- 370g
- 1 year (in case of damage caused by user’s
-mistake, repair/exchange will be charged)
Name of model
Purpose of use
Pads type
Pads quality
Product size
Product weight
Product life
Free warranty
- P-303
- Electric shock and delivery of impedance signal
- Adhesive pads for both adult/kid
- Polyolefin form, adhesive elements: 180-129A
- 145(H) x 98(W) x 1(T)
-120g
- In case of storage of sealed package, 2 years from
- date of manufacture; use immediately on opening
- packing (single-use)
- 2 years (in case of damage caused by user’s mistake,
repair/exchange will be charged)., In case of more
than single-use, exchange with new one is essential
4.1.3 Accessories
HR-501,501T portable case
P-303 (HR-501 electric pads)
HR-B1 (HT-501, 501T)
HR-B1 (HT-501, 501T)

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HR-501 AED User Manual
READY USE MANAGEMENT OTHER
BT-303 (HR-501 battery)
BT-303 (HR-501 battery)
Name of model
Purpose of use
Case type
Pads quality
Product size
Product weight
Number of
shocks
Battery life
Free warranty
Warranty in
charge
- HR-501 battery, BT-303
- Stable power supply
- Adhesive pads for both adult/kid
- Plastic
- 60(H) x 175(W) x 25(T)
- 285g
- More than 200 times
- Standby mode - 2~4 years from date of manufacture
- Uninstalled: 3~4 years from date of manufacture
- 4 years (in case of damage caused by user’s
- mistake, repair/exchange will be charged)
- 5 years

20 HR-501 User Manual (Ver.2.3)
4.2 Indications of Use
4.2.1 Indications of Use
Heart Guardian, HR-501 is manufactured for anyone to
operate with ease, but we encourage every potential user
to complete operation education and practice inadvance
for adequate and quick product operation. RADIAN Inc.
conducts education of CPR and AED in accordance with
customer request. Visit RADIAN’s website (www.radian.co.kr)
and refer to the education menu.
4.2.2 Subject of Product Use
Heart Guardian, HR-501 is an emergency medical device
used on patients who stop breathing and lapse into
unconsciousness due to sudden cardiac arrest.
No response in spite
of shaking Unusual breath No detection of blood
circulation
Warning: The AED is prohibited for use in case of
response or consciousness of patient.