RADIANQBIO HR-501 User manual

Automated External Defibrillator
User manual
Rev. 2.
4
.4

1
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 RADIANQBIO
 Data without any quotation mark may be different from estimated data as
compared to actual data

2
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
Intended use including intended user 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 .............................................................................. 6.1
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-303R (Battery) ................................................ 7.6
FFT ECG Analysis ........................................................................ 7.7
Guidance and Manufacturer’s Declaration .................................... 7.8

3
1 Symbol 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 RADIANQBIO 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 or
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
Expiration date
AED pads shall be
replaced after marked
date
Do not expose to
sunlight
Do not expose to direct
sunlight

4
Symbol Explanation Symbol Explanation
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
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. NB is
DNV GL Presafe AS
50
0
C
IP55

5
Symbol Explanation Symbol Explanation
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
Self- diagnosis for
system check-up
First Aid
Safety messages for
emergency response
protocol and
compliance
Read the instructions
before using
Read & understand user
manual before using this
product
Use no hooks
Absolutely no hand
hooks should be
attached to pull the
parcel
Fragile
Handle with care
This way up
For the duration of
shipping/delivery, the
carton should face
upright
Stacking Limit
Maximum number (6) of
identical transport
packages/items

6
2 Warning 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
25 kg, 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

7
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-303R)
Recharge or heat/damage on battery(BT-303R) 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.
RADIANQBIO is not responsible for electric shock hazard
resulted by unauthorized disassemble or repair. Please
contact 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 because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.
• Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
• Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the HR-501, including cables specified by the
manufacturer.

8
Do not use battery not provided by RADIANQBIO
RADIANQBIO 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. Please refer to the pads location
according to patient's population, adult or child. There should
be no air bubble between pads and applied site. Users shall
make sure the patient’s skin is clear and dry prior to the AED
pad attachment
.
Do not place the pads close to
each other.
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. This pouch bag contains
disposable pads. Do not open the package before use. If the
sealed package is damaged or opened, exchange it to new
one immediately.
• When the package was opened, the pads should be used
immediately and replace the pads every 24 hours for long
term use.
•
Do not fold or apply excessive force to
the package.
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
Main device of HR-501, battery and electro-pads
recommend to maintain between 0˚C ~ 50˚C.
In case of shipping/transporting(within 5days) condition will
be maintain between -20˚C ~ 60˚C(within 5days), If it is out
of 0
˚C ~
5
0
˚
.

9
Do not expose AED to water or liquid directly
IP55 grade is not capable of blocking direct inflow of liquid
completely. In case of water or liquid inflow inside the AED,
there may cause ma
lfunction 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
Do not modify
• No modification of this equipment is allowed
• Do not modify this equipment without authorization of the
manufacturer
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 2015 guidelines
defined by AHA
IP55

10
3 Limited 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
RADIANQBIO 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 RADIANQBIO’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-303R)
 4 years from date of manufacture (indicated on product label)
3.3.3 AED Pads (P-303)
 2 years from date of shipment (indicated on the surface of pads)

11
3.4 Product repair/exchange
An inspection can be performed by RADIANQBIO (or regional
representative) to check the warranty period and trace 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 completed within maximum of 50 days
from the day the product arrives at RADIANQBIO, which are automatically
added up to remaining warranty period

12
4 Product introduction
Please consult the quick guide 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
2015
4.1.1 Functions

13
○
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

14
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 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 (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)
Warranty Life time – 5yrs from date of manufacture
Product Color Red
Basic Components AED portable case(HR-B1), AED pads(P-303),
Battery(BT-303R), User Manual, Quick guide

15
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
Warranty: 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)
mm
Weight :
120g
Warranty : 2/3 years (in case of damage caused
by user’s mistake, repair / exchange
will be charged)
Shelf Life : Single use only, 2 years for the
shipping date
BT
-
303
R
,
HR
-
501 Battery
Model :
BT-303R
Usage ;
Electric power supply to AED
Type :
LiMnO2 (DC 12V 4
.
2A
h
)
Size :
60
(H) x
175
(W) x
25
(T)
mm
Weight :
285
g
Warranty : 4 years (in case of damage caused by
user’s mistake, repair / exchange will
be charged)
Shelf Life : 4 years in standby mode
 Life of Battery is different from temperature and humidity during storage. Management is necessary to follow this guidance.
 While keep by wait mode, Life of Battery is decreasing as time goes by and is possible to reduce the number of electric shock.

16
4.2 Intended use including intended user and patients
The Heart Guardian HR-501 is a device that automatically analyzes the heart rhythm in
victims of cardiac arrest, and delivers an electrical shock to the heart to restore its normal
rhythm.
The Heart Guardian HR-501 is intended by personnel who have been trained in its
operation. Intended users should have received training in basic life support / AED,
advanced life support or a physician-authorized emergency medical response training
program.
The Heart Guardian HR-501 is indicated for use with electric pads (on patients greater than
8 years old or over 25 kg when used with the adult mode and/or on patients between 1 and
8 years of age or up to 25 kg when used with the child mode).
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.
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.
4.2.1 Indications for Use
Use the Heart Guardian HR-501 with P-303 when the patient:
1. is unconscious and unresponsive; or
2. is not breathing normally; or
3. has not a detectable pulse or other signs of circulation.
No response Unusual or no breath Not detection of blood
circulation
4.2.2 Contraindications for Use
Do not use the Heart Guardian HR-501 when the patient:
1. is conscious; or
2. is breathing; or
3. has a detectable pulse or other signs of circulation.

17
4.2.3 Potential adverse effects
Below is a list of the potential adverse effects (e.g., complications) associated with the
use of the device.
• Failure to identify shockable arrhythmia;
• Failure to deliver a defibrillation shock in the presence of VF or pulseless VT, which
may result in death or permanent injury;
• Inappropriate energy which could cause failed defibrillation or post-shock
dysfunction;
• Myocardial damage;
• Fire hazard in the presence of high oxygen concentration or flammable anesthetic
agents;
• Incorrectly shocking a pulse sustaining rhythm and inducing VF or cardiac arrest;
• Bystander shock from patient contact during 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.
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
① Open 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.radianqbio.co.kr’ for downloading
I. HR-501 AED
II. P-303 AED Pads
III. BT-303R Battery (Non-rechargeable)
IV. HR-501 User Manual
V. Quick Guide
② Insert a battery pack (BT-303R) into the battery slot

18
③ For safe storage, always keep AED in the portable case(HR-B1)
④ Place AED at a highly visible and accessible location
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 25 kg
Child Mode
Below age of 7 or Maximum weight 25 kg
4.3.2.2 Turn on the power by pushing power button
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.

19
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
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
.
Prepare the patient for AED operation
• Remove moisture from the patient's chest skin so that the
pads are well adhered, then shave the chest fur if necessary.