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

3Limited warranty
3.1 Customer requirement and product registration
Product registration regarding the purchased product may be necessary based on
the national regulations for AED
3.2 Warranty details
RADIAN Corp., provides warranty to original purchaser of HR-501(including
battery and AED pads but varies the covering time periods) that guarantees free
replacement and repair service. Warranties and returning policies may vary by
products and periods depends on regional regulations and RADIAN’s sales
policy. Please contact sales representatives for more details.
Following cases are exceptions of warranty coverage:
3.2.1 Defect caused by 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 disaster such as fire, earthquake, flood, and
thunder stroke
3.2.5 Defect caused by use/storage in extreme temperature or humidity
environment, please refer to ‘Chapter 5 Guidance for maintenance’
3.2.6 Unauthorized alternation of purchase date, purchaser name, vender, and
serial number
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-303)
4 years from date of manufacture (indicated on product label)
3.3.3 AED Pads (P-303)
2 years from date of manufacture (indicated on the surface of pads)

3.4 Product repair/exchange
An inspection can be performed by Radian (or regional representative) to check
the warranty period and trace the defect. Once Radian 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
completed within maximum of 50 days from the day the product arrives at
RADIAN Corp., which are automatically added up to remaining warranty
period

4Product introduction
Please consult the quick manual and user manual prior to AED
operation
It is highly recommended for every potential user to complete
periodic training for CPR and HR-501 operation. Please contact
national/local representative for Heart Guardian series to find out
detailed 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. Heart
Guardian, HR-501 is manufactured based on CPR guideline of AHA revised in
2010
4.1.1 Functions

○
A
Power Button
Used to turn on or off the product
○
B
Summarized Instruction
Simple Instruction for CPR and AED use
○
C
Status indication light
LED light informs about product status to
user by blinking to various color
○
D
Handle
For carrying AED safely
○
E
Cover
Prevents external substances exposure to
AED
○
F
Battery
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 patient
○
I
Adult/Child Mode Switch
Select Adult/Child mode, default is Adult
mode
○
J
Procedure LED Guidance
LED light informs CPR and AED operating
procedure to user
○
K
Bluetooth Port
Communication port for maintains of AED
○
L
Battery Slot
Mount the battery correctly to this slot
○
M
Speaker
Speaker for Audio guidance

4.1.2 Specification
Product Type
Semi-automated External Defibrillator
Auto/Manual Diagnosis
Automatic diagnosis (battery power, circuit power,
button operation checks)
ECG complete analysis
FFT ECG Analysis
Step by Step Audio
Guidance
Voice record (English)
Compatible Adult/Child
Adult/child mode switch (default)
Charge Method
Hi-Cap charge
Output Range
150J±10% (Adult) / 50J±10% (Child)
Data Storage
108 times of ECG log can be recorded
Control Button
Power, Analysis, Shock, Adult/child mode switch
Battery Type (BT-303)
LiMnO2 (12V DC 4.2A)
Number of shock
At least 200 times (New battery)
AED Pads Type (P-303)
AED electric prods(single-use), 2 lead wire(2m),
4-hole plug
Product Size (mm)
225(W) x 320(L) x 85(H)mm
Product Weight (kg)
2.2kg (battery included, AED case and electric
pads excluded)
Product Color
Red
Basic Components
AED portable case(HR-B1), AED pads(P-303),
Battery(BT-303), User Manual, Quick guide

4.1.3 Accessories
HR-B1 (Portable AED case)
Model :
HR-B1
Usage ;
Storage and protection
Type :
Plastic, Artificial Leather
Size :
235(W) x 330(H) x 95(T)mm
Weight :
370g
Life time :
1 year(Portable)
10 years(Storage)
P-303, AED Pads
Model :
P-303
Usage ;
Delivers electric shock to patient,
Detect Patient’s ECG signal
Type :
Adhesive pads for both
adult/child
Size :
145(H) x 98(W) x 1(T)
Weight :
120g
Warranty :
2 years (in case of damage
caused by user’s mistake, repair /
exchange will be charged)
Life time :
Single use only, 2 years for
unpacked/sealed product since
the manufacturing date
BT-303, HR-501 Battery
Model :
BT-303
Usage ;
Electric power supply to AED
Type :
LiMnO2 (DC 12V 4.2Ah)
Size :
60(H) x 175(W) x 25(T)
Weight :
285g
Warranty :
4 years (in case of damage
caused by user’s mistake, repair /
exchange will be charged)
Life time :
4 years for standby mode

4.2 Indications of use
It is highly recommended for every potential user to complete periodic training
for CPR and HR-501 operation. Please contact national/local representative for
Heart Guardian series to find out detailed CPR and AED operating training
schedule
Heart Guardian, HR-501 is an emergency medical device used for patient stops
in breathing lapsed into unconsciousness due to sudden cardiac arrest
No response Unusual or no breath
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.
AED is prohibited for use in case of response or consciousness of patient

4.3 Getting started
Once AED is powered on, every operation procedure is guided by voice
recorded audio guidance and beep sound with picture description with LED. For
a brief operation training, refer to quick guide provided with the product
4.3.1 Preparation
①Open 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.radian.co.kr’for downloading
I. HR-501 AED
II. HR-501 User Manual
III. P-303 AED Pads
IV. BT-303 Battery (Non-rechargeable)
V. Quick Guide
②Insert a battery pack (BT-303) into the battery slot
③For safe storage, always keep AED in the portable case(HR-B1)
④Place AED at a highly visible and accessible location
Do not remove sealed package which contains AED pads (P-303). Once
the package is opened, the adhesive material on AED pads will get dry
continuously and that would result improper pads attachment

4.3.2 AED Operation
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)
Adult Mode
Above age of 8 or Minimum weight 25kg
Child Mode
Below age of 7 or Maximum weight 25kg
4.3.2.2 Turn on the power by pushing power button
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
4.3.2.4 Attach AED Pads to the patient, and connect pads to AED
○
1Take the AED pads out
○
2Remove the covering package
and tear off the covering stickers
○
3Attach the pads to patient’s chest
○
4Connect 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
Saving time is very important for sudden cardiac arrest patient
Time shall not be wasted on taking off the clothes. Remove
patient’s top as quickly as possible even by cutting or ripping it