Accuniq BC720 User manual

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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.
29, Gongdan-4-ro, Jillyang-eup, Gyeongsan-si, Gyeongsangbuk-do, 38470
Republic of Korea
TEL: [phone], FAX: [phone]
VITAKO Sp. z o.o.
ul. Stanisława Żaryna 7c 02-593 Warszawa, POLAND
TEL: [phone]

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INTRODUCTION ............................................................................................................................. 5
1. INTENDED USE ....................................................................................................................... 5
2. WORD DEFINITIONS................................................................................................................ 5
3. CLASSIFICATION AND COMPLIANCE.................................................................................... 6
4. SAFETY PRECAUTIONS.......................................................................................................... 6
5. SAFETY SYMBOLS AND INFORMATION.................................................... ...........................11
6. Guidance for Electromagnetic compatibility(EMC) .................................................................. .13
ABOUT BODY COMPOSITION ······················································································18
TERM AND FUNCTION OF EACH PART ·········································································20
1. Basic Package ······································································································20
2. Options ················································································································21
3. Appearance of the device ························································································23
4. Term of each parts and its function ···········································································24
INSTALLATION ···········································································································27
1. Power Supply ·······································································································27
2. Peripheral Device Installation ···················································································28
1) Connecting Computer ··························································································28
2) Connecting Printer ······························································································28
3) Connecting Blood Pressure Monitor·········································································29
4) Connecting ultrasonic height meter··········································································30
SYSTEM SETUP ·········································································································31
1. Sorts ···················································································································31
2. Entering SYSTEM SETUP ······················································································31
3. Entering ‘MENU’ view ·····························································································31
4. How to move into ‘SYSTEM SETUP’ ·········································································32
5. How to escape from ‘SYSTEM SETUP’ ·····································································32
6. Setup ··················································································································33
INITIAL SCREEN SETTING ··························································································41
MEASUREMENT AND ANALYSIS ··················································································42
1. Precautions for Measurement ··················································································42
2. Correct Posture ·····································································································43
3. Measuring Procedure ·····························································································46
1) Basic Analysis ····································································································46
CONTENTS

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2) Procedure using Height Meter ············································································· 50
3) Procedure using Blood Pressure Monitor ······························································ 51
STORAGE OF DATA USING USB MEMORY ··································································· 52
PRINTING ················································································································ 54
RESULT INTERPRETATION ························································································ 55
STORAGE & MAINTENANCE ······················································································ 61
ERROR & REPAIR ···································································································· 62
1. Kinds of Error & Repair ························································································· 62
2. Error Occurrence & Repair ···················································································· 64
AFTER SERVICE ······································································································ 65
1. AFTTER SERVICE ····························································································· 65
2. PACKING AND TRANSPORT ··············································································· 65
SPECIFICATION ······································································································· 66
WARRANTY ············································································································· 68
INSTRUCTIONS FOR ASSEMBLY ··············································································· 69
1. HOW TO INSTALL A DEVICE ··············································································· 69
2. ASSEMBLING AN Bluetooth (OPTION)···································································· 74
3. ASSEMBLING A HEIGHT METER (OPTION) ·························································· 77
4. ASSEMBLING AN ANKLE ELECTRODE (OPTION) ·················································· 85

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INTRODUCTION
We highly appreciate that you chose our company’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.
1. INTENDED USE
This device measures impedance by bioelectrical impedance analysis method and provides
lots of information using measured impedance and inputted personal data (height, age, gender,
weight).
It shows body composition of MBF, LBM, SLM, SMM, TBW, protein mass, mineral mass, etc.
and information regarding BMI, PBF, BMR, abdominal analysis, Target to control, segmental
analysis, Body composition change, etc.
2. 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.
Particular attention must be paid to all warnings, cautions and notes incorporated herein.
The following conventions are used throughout the manual to denote information of special
emphasis.
Warning
"Warning" indicates important information about the presence of a hazard
which may cause severe personal injury, loss of substantial property,
damage if the warning is ignored.
Caution
"Caution" indicates important information about the presence of a hazard
which may cause minor personal injury or property damage if the caution is
ignored.
Note
"Notice" indicates important information in order to notify installation,
operation or maintenance of this device. "Notice" is important but not
hazard-related. Hazard warnings are not included here.
3. CLASSIFICATION AND COMPLIANCE

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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).
4. SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of the safety of the operator
and subject and also the reliability of the unit.
The following warnings, precautions and notes must be observed for safety;
Warning
During measurement of the body composition, a microcurrent of 180μA flows
through the body. Individuals who have any kind of implanted active medical
devices, such as pacemakers, should not use this equipment because the
microcurrent can cause malfunction in the implanted device.
Warning
To prevent fire hazard, use only a correctly wired (100-240VAC) outlet, and do not
use a MSO(Multiple Socket Outlet) that is not in compliance with IEC 60601-1.
Warning
To reduce the risk of electric shock or product damage, never plug-in or
plug-out with wet hands.
Warning
Physically disabled persons should not attempt to take measurements alone, but
instead should have their caretakers assist them in using the device.
Caution
The unit must be operated only by, or under supervision of a qualified
person with our company or our distributors.
Caution If you have experienced any trouble with the unit, switch it off immediately,

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and contact our company or its authorized dealer for assistance.
Caution
If you plan to connect any device from other manufacturers electrically or
mechanically to the unit, contact our company 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 950 or equivalent
standards for data processing equipment.
Configurations shall comply with the system standard EN 60601-1:2006.
Everybody who connects additional equipment to the signal input part or
signal output part configures a medical system by standard EN 60601-
1:2006.
If in doubt, consult the A/S department of local distributor.
Caution
Avoid the following environments for storage;
- Where the ambient temperature falls below -25°C or exceeds 70°C.
-
Where the atmospheric pressure falls below 70kPa (700mbar) or exceeds
106kPa (1060mbar).
- Where the humidity is over 93% 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.
- 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.
Caution
This device needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in
the ACCOMPANYING DOCUMENTS.
Caution
Cross contamination is possible because this equipment is used with bare
hands and feet. Refer to the cleaning and disinfecting methods in this
manual.

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Caution
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.
Prohibition
Do not disassemble or alter the device under any circumstances, as this
could result in electric shock or injury as well as adversely affect the
precision of measurements.
This device is specified as Class 1 type BF unit under the standard EN
60601-1: 2006(Basic safety and essential performance of Medical
Electrical Equipment). Therefore, patients must not touch or handle inner
side of the system at any time.
Prohibition
Do not to touch signal input, signal output or other connectors, and the
patient simultaneously.
Prohibition
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.
Prohibition
Never pour any liquid directly on the scale platform, as it may leak and
cause internal damage..
Prohibition
Never jump on the Weighing Platform, there may be a risk of stumbling
and malfunction of the equipment.
Note
This equipment has been tested and found to comply with the limits for
medical devices according to 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

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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.
Note
Place the Weighing Platform on a level and stable surface. If the equipment
is used when the Weighing Platform is unstable because not all feet are on
the surface, there may be a risk of stumbling or inaccurate measurement.
Note
Note that portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT.
Note
Consult a physician or a trained health professional for interpretation of
measurement results.
Note
In case of patients who have certain diseases, the estimates might be
different.
Note
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.
This manual is made for informational purposes and this manual and
product are not meant to be a substitute for the advice provided by your own
physician or other medical expert. You should not use the information
contained in the product for diagnosis or treatment of health problems or
prescription of medication by yourself. If you have or suspect that you have
a medical problem, consult with your physician promptly.
Defective units or accessories must be packed in the replacement cartons to

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be shipped off from you to our company.
Shipping and insurance costs for return of defective unit must be prepaid by
the users.
Caution
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.
Note
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.
This manual is made for informational purposes and this manual and
product are not meant to be a substitute for the advice provided by your own
physician or other medical expert. You should not use the information
contained in the product for diagnosis or treatment of health problems or
prescription of medication by yourself.
If you have or suspect that you have a medical problem, consult with your
physician promptly.
Defective units or accessories must be packed in the replacement cartons to
be shipped off from you to our company.
Shipping and insurance costs for return of defective unit must be prepaid by
the users.

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5. 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 warning of any potential hazard.
The classifications and symbols are shown below. Save these instructions for your safety.
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.
/
"ON / OFF" key : Turn the power ON / OFF
Class II equipment

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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
For indoor use only
RoHS2

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6. Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the ACCUNIQ BC720 are given below.
Before using the ACCUNIQ BC720, be sure to read and understand the following information.
1) Guidance and manufacturer’s declaration – electromagnetic emissions
The ACCUNIQ BC720 is intended for use in the electromagnetic environment specified below.
The customer or the user of the ACCUNIQ BC720 should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The ACCUNIQ BC720 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
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
The ACCUNIQ BC720 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.

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2) Guidance and manufacturer’s declaration – electromagnetic immunity
The ACCUNIQ BC720 is intended for use in the electromagnetic environment specified below.
The customer or the user of the ACCUNIQ BC720 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.
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 ACCUNIQ BC720 requires
continued operation during power
mains interruptions, it is
recommended that the ACCUNIQ
BC720 be powered from an
uninterruptible power supply or a
battery.
Magnetic field 3 A/m 3 A/m Power frequency magnetic fields

15
of commercial
frequency
(50/60Hz)
IEC 61000-4-8
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.
3) Guidance and manufacturer’s declaration – electromagnetic immunity 2
The ACCUNIQ BC720 is intended for use in the electromagnetic environment specified below.
The customer or the user of the ACCUNIQ BC720 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
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
ACCUNIQ BC720, including
cables, than the recommended
separation 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).

16
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:
Note
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
ACCUNIQ BC720 is used exceeds the applicable RF compliance level
above, the ACCUNIQ BC720 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the ACCUNIQ BC720.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.

17
Recommended separation distances between portable and mobile RF communications
equipment and the ACCUNIQ BC720
The ACCUNIQ BC720 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the ACCUNIQ BC720 can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the ACCUNIQ BC720 as
recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power
of transmitter
W
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.
Note
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.

18
ABOUT BODY
C
OMPOSI
TION
1. Body Composition
Human body consists of body fat and lean body. Lean body means non-fat constituents of
human body like body water, muscles, mineral, etc.
Body water is divided into intra- and extra-cellular water and the ratio between them is
controlled and maintained within a certain range. Body fat is piled beneath the skin and
between abdominal organs. Body fat is hydrolyzed to make energy needed to normal
physiological function when energy supply through food intake is not sufficient, but excessive
fat in the body itself is a kind of disease and causes lifestyle diseases.
Healthy people maintain the balance of body composition in a steady proportion but
unhealthy people persons fail to keep this balance. When the balance in body composition is
broken, diseases like obesity, malnutrition, osteoporosis, etc. can be caused.
2. Obesity
Various methods can be used to assess obesity but the key factor in obesity assessment is
the amount of fat accumulated in the body.
In general, obesity is defined as the state of not only excessive weight compared with height
(visible obese) but also excessive body fat compared with weight (invisible or visible obese).
Strictly speaking obesity is the state that body fat occupies considerably high ratio to weight.
3. Necessity of Body Composition Analysis
Body Composition Analysis is a good indicator in finding possible health problems. Body
composition analysis enables professionals to find obesity or imbalance in body composition
at an early stage and helps subjects keep their body healthy.
4. Waist to hip ratio
Waist to hip ratio (W.H.R.) shows the distribution of fat stored in one’s abdomen and hip. It is
simple but useful to assess body fat distribution. Body fat is stored in two distinct ways. They
are often categorized into and called 'apple' and 'pear' type. Apple type shows bigger girth of
waist than hip and pear type has bigger girth of hip than waist. If body fat in abdomen
increases more, the risk to cardiovascular diseases, diabetes, etc. becomes higher.
5. Abdominal Fatness
Body fat is divided into subcutaneous fat and visceral fat. Visceral obesity is considered to be
a critical risk factor along with Percentage of body fat.
Lipoprotein lipase can be easily activated in visceral fat, and it causes visceral fat to be
dissolved easily. Dissolved visceral fat goes into liver through the blood vessel and causes
fatty liver or increases lipid in the blood. It also elevates the risk of hyperinsulinemia,

19
hypertension, and cardiovascular disease.
Visceral fat generally occupies 10 ~ 20 % of body fat and visceral obesity is assessed based
on the indicators below.
- the cross sectional fat area between L4 ~ L5 is 100 cm2 and over
- the visceral fat to subcutaneous fat ratio is 0.4 and over
- the waist to hip ratio (W.H.R.) is over 0.9 (male) / 0.85 (female)
- the circumference of waist is over 102 cm/45 inches (male) _ 88 cm / 35 inches (female)
Visceral fat increases after 30s in men and after Menopause in women. It is more common in
men than women and the old than the young. Visceral fat tends to increase with aging.
Because the combustion rate per minute of visceral fat is higher than that of subcutaneous
fat, visceral fat can be easily reduced by exercise or dietary control in case of abdominal
obesity. W.H.R. is the ratio of waist to hip circumference and has relation to one’s figure.
6. Segmental Analysis
This device analyzes soft lean mass, body fat mass, total body water and E.C.W./T.B.W. of
five body parts; trunk, right arm, left arm, right leg, and left leg. This function can be used as
an assessment tool to evaluate the result of exercise or rehabilitation treatment.
7. Age Matched of Body
It is the estimated physical age of the subject considering body composition analysis result,
gender, and biological age. This is calculated by comparing the optimal body composition
based on the gender and biological age of the subject with the actual analyzed body
composition. It can be used to evaluate the subject’s health and body development.
8. Study
It is the provided impedance.
Impedance indicates the segmental impedance of five body parts (left and right arms, left and
right legs, and trunk) corresponding to each frequency (1~ 1000 kHz).

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1. Main Parts
The main system of ACCUNIQ BC720 consists of as follows.
① Main body
② User manual
③ Adapter
④ USB Cable
⑤ Data management program
⑥ Bolts
⑦ 5mm L-wrench
⑧ Body Cover
⑨ Bluetooth
※ Model or specification of accessories can be changed according to market supply and
demand.
TERMS OF EACH PART AND
FUNCTION
② User manual
①
Main body
④ USB Cable
③ Adapter
⑥ Bolts
⑦ 5mm L-wrench
⑤ Data management
program
⑧ Body Cover
⑨ Bluetooth