SELVAS Healthcare Accuniq BC380 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.
155, Shinseong-ro, Yuseong-gu, Daejeon, 34109 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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CONTENTS
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) ................................................................... 14
ABOUT BODY COMPOSITION ···················································································19
TERMAND FUNCTION OF EACH PART ······································································21
1. Basic Package ···································································································21
2. Options ············································································································22
3. Appearance of the device ·····················································································24
INSTALLATION ········································································································27
1. Power Supply ····································································································27
2. Peripheral Device Installation ················································································28
1) Connecting Computer ······················································································28
2) Connecting Printer ···························································································29
3) Connecting Blood Pressure Monitor······································································31
4) Replacing of thermal paper (OPTION) ··································································32
SYSTEM SETUP ·····································································································34
1. Entering SYSTEM SETUP ···················································································34
2. Menu in SYSTEM SETUP ····················································································35
3. Setup ··············································································································36
MEASUREMENT AND ANALYSIS ···············································································41
1. Precautions for Measurement ···············································································41
2. Correct Posture ·································································································42
3. Measurement ····································································································44
RESULT INTERPRETATION ·······················································································50
STORAGE & MAINTENANCE ·····················································································55

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ERROR & REPAIR ·································································································56
1. Troubleshooting & Repair ··················································································· 56
2. Error Occurrence & Repair ················································································· 57
AFTER SERVICE ··································································································· 58
1. AFTTER SERVICE ·························································································· 58
2. PACKING AND TRANSPORT ············································································ 58
SPECIFICATION ···································································································· 59
WARRANTY ········································································································· 61
INSTRUCTIONS FOR ASSEMBLY ············································································· 62
1. HOW TO INSTALL The DEVICE ········································································· 62
2. ASSEMBLING The HEIGHT METER (OPTIONAL) ················································· 69
3. ASSEMBLING The ANKLE ELECTRODE (OPTIONAL) ··········································· 80
4. ASSEMBLING The THERMAL PRINTER (OPTIONAL) ············································ 86

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INTRODUCTION
We thank you for choosing the BC380.
Please familiarize yourself with these instructions before using this product and always keep them
on hand for easy reference. If you are not sure about an operation, or you experience problems
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.

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3. 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/A1:2013(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 EN 60601-1-2:2007/AC:2010(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) with other device that is not in compliance with EN
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.

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Caution
If you have experienced any trouble with the unit, switch it off immediately, 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/A1:2013.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system by standard EN 60601-1:2006/A1:2013.
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.

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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.
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/A1:2013(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.

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Note
This equipment has been tested and found to comply with the limits for medical devices
according to EN 60601-1-2:2015. 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.
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.

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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.
Warning
Do not modify this equipment without authorization of the manufacturer.
Warning
Connect the earth placed on the backside of this device to terminal plate to prevent any
electric shock from leakage current or a potential difference.
Warning
To avoid the risk of electric shock, this equipment must only be connected to supply
mains with protective earth.
Caution
Do not put anything other than the main unit and Selvas’s blood pressure monitor
within 1.5 m from the patient.
Caution
Do not touch any other devices other than those specified by the manufacturer.

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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
This way up
Fragile

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Use no hooks
For indoor use only
RoHS2

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6. Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the ACCUNIQ BC380 are given below.
Before using the ACCUNIQ BC380, be sure to read and understand the following information.
1) Guidance and manufacturer’s declaration –electromagnetic emissions
The ACCUNIQ BC380 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BC380 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The ACCUNIQ BC380 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 ACCUNIQ BC380 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

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2) Guidance and manufacturer’s declaration – electromagnetic immunity
The ACCUNIQ BC380 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BC380 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 BC380 requires
continued operation during power
mains interruptions, it is
recommended that the ACCUNIQ
BC380 be powered from an
uninterruptible power supply or a
battery.

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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.
3) Guidance and manufacturer’s declaration – electromagnetic immunity 2
The ACCUNIQ BC380 is intended for use in the electromagnetic environment specified below. The
customer or the user of the ACCUNIQ BC380 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 BC380, 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

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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:
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.
aField 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 BC380 is used
exceeds the applicable RF compliance level above, the ACCUNIQ BC380
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or
relocating the ACCUNIQ BC380.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.

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4) Recommended separation distances between portable and mobile RF communications
equipment and the ACCUNIQ BC380
The ACCUNIQ BC380 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ACCUNIQ BC380 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ACCUNIQ BC380 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.
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.

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ABOUT BODY COMPOSITION
1. Body Composition
Human body consists of body fat mass and lean body mass. Lean body mass refers to non-fat
components of human body like body water, muscles, minerals, etc.
Body water consists of both intra- and extra-cellular water, and the ratio between them is
controlled and maintained within a certain range. Body fat is stored beneath the skin and
between abdominal organs. Body fat is hydrolyzed to make energy needed to perform normal
physiological functions when energy supply through food intake is not sufficient, but excessive fat
in the body is a type of disorder, often caused by adverse lifestyle conditions.
Healthy people maintain a steady proportional balance of body composition, but unhealthy
people fail to keep this balance. When the balance in body composition is compromised,
diseases like obesity, malnutrition, osteoporosis, etc. can result.
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 obesity), but also excessive body fat compared with weight (invisible or visible obesity).
Strictly speaking obesity is the state in which body fat occupies a considerably high proportion as
compared to weight.
3. Necessity of Body Composition Analysis
Body Composition Analysis is a useful indicator for identifying possible health problems. Body
composition analysis enables professionals to detect 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 as 'apple' and 'pear' types. Apple type indicates a larger waist than hip and
pear type is characterized by a larger hip than waist. If body fat in the abdomen increases, the
risk of cardiovascular diseases, diabetes, etc. becomes higher.

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5. Abdominal Fatness
Body fat consists of 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 a fatty liver or
increases lipid in the blood. It also elevates the risk of hyperinsulinemia, hypertension, and
cardiovascular disease.
Visceral fat generally occupies 10 ~ 20 % of body fat. Visceral obesity is assessed based on the
indicators below.
- the cross sectional fat area between L4 ~ L5 is 100 cm2and 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/40 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 and mass of body fat in five body segments: 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 the 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.