SELVAS Healthcare ACCUNIQ BP500 User manual

English. 06/2021. V3.02
User Manual BP500

The device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC.
THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93/42/EEC
SELVAS Healthcare, Inc.
155, Sinseong-ro, Yuseong-gu, Daejeon, 34109 Republic of Korea
TEL: [phone], FAX: [phone]
Obelis s.a.
Bd. Général Wahis, 53, B-1030, Brussels, Belgium
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established.

CONTENTS
FUNCTION_3
CONTENTS
CONTENTS................................................................................... 3
INTRODUCTION ........................................................................ 5
INTENDED FOR PUBLIC USE...................................... 5
CONTRAINDICATIONS FOR USE.............................. 5
WORD DEFINITIONS...................................................... 5
CLASSIFICATION AND COMPLIANCE.................... 6
SAFETY PRECAUTIONS ................................................. 6
SAFETY SYMBOLS AND INFORMATION .............. 9
Guidance for Electromagnetic compatibility
(EMC)...................................................................................11
FUNCTION 15
The front of the main unit.................................................15
Printing Section.......................................................................16
Rear of the main unit ...........................................................17
Accessories ................................................................................18
Options........................................................................................18
INSTALLATION 19
Installing on the Table .........................................................19
How to connect the power ...............................................20
How to insert thermal paper............................................21
How to connect the communication port.................22
How to set basic functions................................................22
How to enter basic function setting mode......23
How to check the cumulative count ...................24
How to change the date and time ......................24
How to set the voice guide volume....................25
How to set the thermal printer..............................25
How to set up additional functions ..............................26
How to enter additional function setting
mode...................................................................................26
How to check the product software version...26
How to set the communication port (RS-
232C)...................................................................................27
How to set the cuff sensor ......................................27
How to install the measurement guide plate ..........28
How to install the rear monitor ......................................28
Composition and description..................................28
How to connect the port..........................................29
Measurement method................................................30
MEASUREMENT 32
Operations .................................................................................32
Operation principles....................................................32
Operation warnings .....................................................32
Operating conditions ..................................................32
Operating steps .............................................................34
Measurement result ..............................................................34
STORAGE & MAINTENANCE 36
ERROR & REPAIR 38
AFTER SERVICE 40
Applying for A/S.....................................................................40
How to contact SELVAS Healthcare .....................40
PACKING AND TRANSPORT..............................................40
SPECIFICATION 42
WARRANTY 43

User Manual BP500
FUNCTION_5
INTRODUCTION FUNCTION
INTRODUCTION
We highly appreciate that you chose SELVAS Healthcare’s product.
You are kindly requested to be familiar with these directions before using this product and always keep it
together with the product. In case you are not sure about any directions or problems arising while using
the product, please contact our service center.
We will provide you with detailed instructions.
INTENDED FOR PUBLIC USE
BP500 Automatic Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and
pulse rate of Persons who are 18 years and older using the oscillometric method on a cuffed arm.
1) Target user: Persons who are 18 years and older
2) This medical device is not for home use
CONTRAINDICATIONS FOR USE
As with any non-invasive measurement device, there are clinical conditions which can influence the
accuracy of the results. Also, the subject's position, physiological condition and other environmental factors
can affect the measurement and/or calculation.
The BP500 Non-Invasive Blood Pressure Monitor should not be used with patients who have the following
conditions:
1) PATIENTS with a known arrhythmia
2) PATIENTS with insufficient peripheral circulation, acute cases of low blood pressure or low temperature
3) PATIENTS experincing a seizure
4) Children younger than 18 years old
5) PATIENTS who should not have blood pressure measurements taken from their arms
6) PATIENTS with an artifical heart
7) PATIENTS whose artery cannot be found by palpation
WORD DEFINITIONS
To ensure safe operation and long term performance stability, it is essential that you fully understand the
functions, operating and maintenance instructions by reading this manual before operating your unit.

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6_FUNCTION
Particular attention must be paid to all Notices, cautions and notes incorporated herein.
The following conventions are used throughout the manual to denote information of special emphasis.
Notice
Important information to indicate any possible hazard which can cause severe personal
injury of death from substantial property damage when ignored.
Caution
Important information to indicate any possible hazard which will or can cause minor
personal injury or property damage when ignored.
Note
Important information to notify to the user about installation, operation, or maintenance
information which is important but not hazardous. Warnings against hazard are not to
be included under the NOTE signal word.
CLASSIFICATION AND COMPLIANCE
1) This device is classified as;
Class 1 type-BF against electric shock
Ordinary equipment without protection against ingress of water
Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of EN
60601-1: 2006(Basic safety and essential performance of Medical Electrical Equipment)
2) This device is complied with Class A for Noise-Emission, Level B for Noise-immunity, by standard of
IEC 60601-1-2:2007(Electromagnetic Compatibility Requirements).
3) This device is complies with the EN 1060-1: 1995+A2:2009 Non-invasive Sphygmomanometers general
requirements as well as EN 1060-3: 1997+A2:2009 supplementary requirements for electro-mechanical
blood pressure measuring systems.
SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of safety of the operator and subject and
also to the reliability of the unit.
The following precautions must be observed for additional safety;
1) The unit must be operated only by, or under supervision of a qualified person with SELVAS Healthcare
or our distributors.
2) Medical Electrical Equipment.

User Manual BP500
FUNCTION_7
INTRODUCTION FUNCTION
Do not touch or handle inner side of the system at any time.
The INTERNAL ELECTRICAL POWER SOURCE is to be used if the integrity of the PROTECTIVE
EARTH CONDUCTOR or the protective earthing system in the installation is in doubt.
3) Pressurization of the CUFF can temporarily cause loss of function of simultaneously used monitoring
ME EQUIPMENT on the same limb;
4) Do not modify the unit. If any modification is needed, ask SELVAS Healthcare or its authorized dealer
for service.
5) The unit has previously been adjusted in the factory for optimum performance.
Do not attempt to adjust switches or any other things except those specified in this manual for
operation.
6) 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.
7) 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.
8) If you have experienced any trouble with the unit, switch it off immediately, and contact SELVAS
Healthcare or its authorized dealer for assistance.
9) If you plan to connect any device of other manufacturers electrically or mechanically to the unit,
contact SELVAS Healthcare or its authorized dealer for instructions before doing so. When you connect
computer or other system to the unit (RS-232C), the attached systems should be those certified by
IEC 60950 or equivalent standards for data processing equipment. Configurations shall comply with
the system standard IEC 60601-1:2005. Everybody who connects additional equipment to the signal
input part or signal output part configures a medical system standard IEC 60601-1:2005. If in doubt,
consult the A/S department of local distributor.
10) Avoid the following environments for storage;
Where the ambient temperature falls -10°C or exceeds 60°C.
Where the atmospheric pressure falls below 70kPa (700mbar) or exceeds 106kPa (1060mbar).
Where the humidity is over 95% non-condensing.
Where the unit is exposed to spray or splashing water.
Where the unit is exposed to dust.
Where the unit is exposed to water vapor.
Where the unit is exposed to salty atmosphere.

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8_FUNCTION
Where the unit is exposed to explosive gas.
Where the unit is exposed to excessive shocks or vibrations.
Where the angle of inclination of mounting surface exceeds 10 degrees.
Where the unit is exposed to direct sunlight.
11) This equipment has been tested and found to comply with the limits for medical devices to the IEC
60601-1-2:2007. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to other devices,
which can be determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
Consult the manufacturer or field service technician for help.
12) Do not to touch signal input, signal output or other connectors, and the patient simultaneously.
13) 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 this equipment, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
14) No phthalates are used for this product and its container.
15) The cuff is not made with natural rubber latex
Caution
1. Measurements may be impaired if this device is used near televisions, microwave
ovens, X-ray equipment or other devices with strong electrical fields. To prevent such
interference, use the meter at a sufficient distance from such devices or turn them
off.
2. Incorrect operation or failure of user to maintain the unit spares the manufacturer or
his agent of the responsibility for system’s non-compliance with specifications or
responsibility for any damage or injury.

User Manual BP500
FUNCTION_9
INTRODUCTION FUNCTION
Caution
1. This manual is made for informational purpose and this manual and product are not
meant to be a substitute for the advice provided by your own physician or other
medical problem. You should not use the information contained in the product for
diagnosis or treatment of health problem or prescription of medication by yourself.
2. If you have or suspect that you have a medical problem, consult with your physician
promptly.
3. Defective unit or accessories must be packed in the replacement cartons to be
shipped off from you to SELVAS Healthcare.
4. Shipping and insurance costs for return of defective unit must be prepaid by the
users.
SAFETY SYMBOLS AND INFORMATION
The International Electro-technical Commission (IEC) has established a set of symbols for medical electrical
equipment which classify a connection or Notice of any potential hazard.
The classifications and symbols are shown below. Save these instructions for your safety.
SYMBOL
INFORMATION
Degree of protection against electric shock: TYPE BF
Please observe operating instructions
General warning sign
General prohibition sign
General mandatory action sign
Caution
Waste Electrical and Electronic Equipment (WEEE)
The device could be sent back to the manufacturer for recycling or proper disposal
after their useful lives. Alternatively the device shall be disposed in accordance
with national laws after their useful lives.
"OFF" (only for a part of equipment)

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10_FUNCTION
SYMBOL
INFORMATION
"ON" (only for a part of equipment)
This symbol is used inside system.
Identifies the point where the safety ground of the system is fastened to the
chassis.
Do not open. This is for factory only.
Alternating current
Direct current
Date of manufacture
Manufacturer
Non-ionizing radiation
CE mark
Serial No.
Authorized representative in the European community.
Keep dry
This way up
Fragile
Use no hooks
For indoor use only
RoHS2
Medical Device

User Manual BP500
FUNCTION_11
INTRODUCTION FUNCTION
Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the BP500 are given below. Before using the
BP500, be sure to read and understand the following information.
Guidance and manufacturer’s declaration –electromagnetic emissions
The BP500 is intended for use in the electromagnetic environment specified below. The customer or the
user of the BP500 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The BP500 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The BP500 is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Guidance and manufacturer’s declaration –electromagnetic immunity
The BP500 is intended for use in the electromagnetic environment specified below. The customer or the
user of the BP500 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment-
guidance
Electrostatic
discharge(ESD) IEC
61000-4-2
±6kV: Contact
±8kV: Air
±6kV: Contact
±8kV: Air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transition/burst
IEC 61000-4-4
±2kV: Power
supply lines
±1kV:
Input/output lines
±2kV: Power
supply lines
±1kV:
Input/output lines
Mains power quality should be that of
a typical commercial or hospital
environment.

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12_FUNCTION
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment-
guidance
Surge
IEC 61000-4-5
±1 kV
differential
mode
2 kV
common
mode
±1 kV
differential
mode
±2 kV
common
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage drops, dips,
and fluctuations of
input power supply
line IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the BP500
requires continued operation during
power mains interruptions, it is
recommended that the BP500 be
powered from an uninterruptible
power supply or a battery.
Magnetic field of
commercial
frequency (50/60Hz)
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Note
UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration –electromagnetic immunity 2
The BP500 is intended for use in the electromagnetic environment specified below. The customer or the
user of the BP500 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
Radiated RF
3 Vrms
150 kHz to 80
MHz
3 V/m
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the BP500, including cables,
than the recommended separation

User Manual BP500
FUNCTION_13
INTRODUCTION FUNCTION
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment-guidance
IEC 61000-4-3
80 MHz to 2,5 GHz
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d =1.2
d =1.2 80 MHz to 900 MHz
d =2.3 900 MHz to 2,5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should be
less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Caution
1. At 80 MHz and 900 MHz, the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the BP500 is used exceeds the
applicable RF compliance level above, the BP500 should be observed to verify

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14_FUNCTION
normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the BP500.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
Recommended separation distances between portable and mobile RF communications
equipment and the BP500
The BP500 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the BP500 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the BP500 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power
of transmitter W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
d =1.2
80 MHz to 900 MHz
d =1.2
900 MHz to 2,5 GHz
d =1.2
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Caution
1. At 80 MHz and 900 MHz, the separation distance for the higher frequency range
applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

User Manual BP500
FUNCTION_15
FUNCTION FUNCTION
FUNCTION
The front of the main unit
①
Time display
Displays the current date and time.
②
Systolic Pressure display
Displays measured systolic pressure.
③
Diastolic Pressure display
Displays measured diastolic pressure.
④
Pulse display
Displays the measured pulse.
⑤
Emergency stop button
If you press this button when you feel acute pain due to too high
pressurization or the product runs abnormally, the cuff air will be
expelled and the product will stop.
⑥
Start/Stop measurement
button
If you press the button after you’re ready for measurement, cuff
pressurization will start automatically. If you press the button,
measurement will stop and the cuff will return to its original state.
⑦
Printer
The printed paper is automatically ejected after measurement.
You don’t have to cut the paper when it comes out, an automatic
cutter is installed inside the printer.
⑧
Cuff
Pressurize or expel air from the cuff during measurement.
⑨
Armrest
Fixes the position and posture of your arm when you put your
arm inside the cuff.
①Time Display
②Systolic Display
③Diastolic Diplsay
④Pulse Display
⑤Emergency Stop Button
⑥Start/Stop Measurement Button
⑨Armrest
⑧Cuff
⑦Printer
DIA
mmHg
SYS
mmHg
PULSE
bpm

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16_FUNCTION
Printing Section
When you open the printer cover, you will see four buttons under the printer.
1) [FEED] button: If you press and hold the button, paper will be ejected and cut automatically.
2) [SET] button, [▲(UP)] button, [▼(DOWN)] button: These buttons are used to change the product
settings. Refer to “How to set basic functions”on page 23 or “How to set additional functions”on
page 27”for the detailed operation method.

User Manual BP500
FUNCTION_17
FUNCTION FUNCTION
Rear of the main unit
①
Power switch
Turns the power on/off.
②
Power port
Connect the adapter here.
③
Rear monitor port
Connect the dedicated cable for the rear monitor (optional) to
the main unit here. If you input your ID, weight, and height when
you use the rear monitor, you can check your systolic, diastolic,
blood pressure measured value of the pulse, and body mass index
(BMI).
④
Communication port No. 2
(E2)
Used to connect the main unit to a computer or other device
using an RS-232C cable and transmits measurement data to the
computer or other device. (Displayed as E2 on the settings
screen.)
⑤
Communication port No. 1
(E1)
Used to connect the main unit to a computer or other device
using an RS-2 32C cable and transmits measurement data to the
computer or other device. (Displayed as E1 on the settings
screen.)
⑥
USB port
Connect a USB cable here.
⑦
Guide plate fixing section
You can insert the product use guide plate here.
①Power Switch
②Power Port
③Rear Monitor Port
④E2 Port
⑤E1 Port
⑥USB Port
⑦Guide Plate
Fixing Section

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18_FUNCTION
Accessories
User Manual
Power adapter and power
cable
Measurement guide plate
Options
Dedicated cart and height
adjustable chair
Thermal printer and thermal
paper
Rear monitor

User Manual BP500
INSTALLATION_19
INSTALLATION INSTALLATION
INSTALLATION
Installing on the Table
1) Install the device by pulling it to the end of the table so that user can measure blood pressure in the
correct position.
2) Recommend that you use a chair or desk with adjustable height to allow measurements in the most
comfortable postion.
3) The device must be located so that the elbows an rest on the rubber botton of the armrest.

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20_INSTALLATION
How to connect the power
1) Connect the enclosed adapter to the power port installed on the rear side of the device.
2) Connect the power and turn on the Power switch on the left side of the input section.
Caution
1. Make sure to use the enclosed adapter and cable to supply power to the device.
2. When connecting the adapter, connect it to the power input section on the back of
the main unit accurately in such a way that the arrow on the adapter connection
section faces upwards as shown in the figure below. If connected incorrectly, problems
can arise in the product.