Radian Heart Guardian AED User manual

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

IMPORTANT
Operators are recommended referring the quick-manual provided with the
original manual carefully for quick and adequate product operation
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
#1610, Halla-Sigma Valley, 53, Gasan Digital 2-ro Geumcheon-gu
Seoul, Korea
[phone]
[email protected]
www.radian.co.kr

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 ........................................................................... 4.1
Indications of use ........................................................................... 4.2
Getting started ............................................................................... 4.3
Preparation ......................................................................... 4.3.1
AED operation ................................................................... 4.3.2
Data management .............................................................. 4.3.3
Guidance for maintenance..........................................Chapter 5
AED location and periodical maintenance ..................................... 5.1
After first-time use ......................................................................... 5.2
Troubleshooting...........................................................Chapter 6
Self-diagnosis ................................................................................ 6.1
AED conditional alarm.................................................................... 6.2
Troubleshooting ............................................................................. 6.3
Technical data..............................................................Chapter 7
Physical parameters ....................................................................... 7.1
Environmental parameters............................................................... 7.2
Functionality ................................................................................... 7.3
Applicable standards ....................................................................... 7.4
Parameters for P-303(AED Pads).................................................... 7.5
Parameters for BT-303 (Battery) ..................................................... 7.6
FFT ECG Analysis.......................................................................... 7.7

1Symbol 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
Symbol
Explanation
Warning
The symbol
implements serious
hazards that may cause
injury or death
Caution
The symbol implements
hazards that may cause an
electric shock, product
damage, and malfunction
Reference
Additional reference
data is referred
Dangerous Voltage
The defibrillator output
has high voltage and may
present a shock hazard
Additional info
Additional information
is described on manual
Type BF Equipment
Connected AED to the
patient’s chest by the
AED pads, may withstand
the effects of an
externally applied
defibrillation shock.
Non-Sterile
Product/Part is not
sterilized
Non-Rechargeable
Do not recharge the
battery
Keep Dry
AED/Accessories shall
be kept dry before or in
use
Relative Humidity
Humidity range to be
maintained

Symbol
Explanation
Symbol
Explanation
Keep away from
ignition materials
Do not operate or keep
AED around ignition
materials
Do not expose or
incinerate to open
flame
Expiration date
AED pads shall be
replaced after marked
date
Do not expose to
sunlight
Do not expose to direct
sunlight
WEEE
Waste Electronic
Electrical Equipment
Separate collection for
waste electrical and
electronic equipment
Direct Current, DC
Direct Current.
Battery Type
Lithium manganese
oxide Battery
Temperature Limit
Product/Part shall be
kept at marked
temperature range
EC 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

Symbol
Explanation
Symbol
Explanation
Protection Level
Protection level that
shows anti-dust and
waterproof level
Maintenance
required
Recycling
Dispose of properly
in accordance with
all state, province,
and country
regulations
CE Mark
This equipment
conforms to
essential
requirements of the
Medical Device
Directive
93/42/EEC
Date of
Manufacture
4 digits of the year and
2 digits of month and
day which indicate the
manufacturing date
Manufacture
Name and address
of manufacturer
Bluetooth
AED supports
Bluetooth wireless
communication
LATEX Free
Power Button
Press the button to
operate AED
Electric Shock
Button
Audio and LED
guidance will notice
to press the shock
button when it is
needed
Adult/Child mode
switch
Confirm Adult/Child
mode switch prior to
AED pads attachment
□
i-button
A dummy button
for system check-up

2Warning 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. Prior to AED operation, it is
very important to check patient’s consciousness and
respiration condition; do not use if the patient is conscious
and reacting
The AED is set to “Adult Mode”as default
In adult mode, AED delivers about 150J of electric 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
25kg, please set “Child Mode”by moving Adult/child mode
switch to the left and attach the pads firmly to appropriate
spots
Adult Child
Be careful of electric shock hazard
Electric shock can be delivered to operator or bystander
through unexpected ways. To avoid this hazard during
AED operation, keep followings:
Do not use AED in standing water, underwater, rain,
snowing. Move patient to a dry area
Confirm and instruct anyone to stay away from the
patient prior to pressing ‘Shock Button’
When patient is contacted with any conductive materials
such as metals, stay away from the conductive materials

Do not use around flammable materials
To avoid possible fire or explosion hazard, do not use around
the following situation/place.
close to flammable materials
close to hyperbaric oxygen tank (within 25m)
close to hydrogen tank (within 25m)
Do not attempt to recharge or cause heat/damage the battery
(BT-303)
Recharge or heat/damage on battery(BT-303) may
cause an explosion or fire hazard. If the battery is low, please
exchange to new one
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
Do not use battery not provided by RADIAN
RADIAN 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
chest firmly and tightly. Users shall make sure the patient’s
skin is clear and dry prior to the AED pad attachment
During ECG analysis, stay away from the patient
Touching the patient during the ECG analysis phase can
cause interference with the diagnostic 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. Also always keep the AED package
sealed prior to the actual use. If the sealed package is
damaged or opened, exchange it to new one immediately
Interference may be caused by implanted pacemaker
With some pacemakers, the AED may not advise an electric
shock
•Do not attach the AED pads directly on an implanted
device
•Attach the AED pads at least 5cm away from any
implanted device
Temperature requirement for stable operation/storage
Battery and AED pads of HR-501 can be stored from -
0℃to 40℃for short term period(under 5 days), but
recommends at least 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℃temperature condition.
Do not expose AED to water or liquid directly
IP54 grade is not capable of blocking direct inflow of liquid
completely. In case of water or liquid inflow inside the AED,
there may cause malfunction or failure of the AED
Operator is to be well-informed of method of AED operation
and CPR in advance
Some national standards restrict AED to be sold by or on the
order of a physician or practitioner licensed by law in which
operator practices to use or order the use of the AED

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
AED maintenance and authorization, responsibility of usage
shall be followed by relevant national and regional regulation
Product disposal
The AED is classified as electronic device. AED shall be
disposed in a way required by the local guideline
HR-501’s CPR guidance is consistent with 2010 guidelines
defined by AHA