SELVAS Healthcare Accuniq BC310 User manual

English. 06/2021. V3.02
User Manual BC310

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

CONTENTS_3
CONTENTS
CONTENTS 3
INTRODUCTION 5
INTENDED USE .......................................................................... 5
WORD DEFINITIONS............................................................... 5
CLASSIFICATION AND COMPLIANCE ............................. 6
SAFETY PRECAUTIONS........................................................... 6
SAFETY SYMBOLS AND INFORMATION......................10
Guidance for Electromagnetic compatibility
(EMC)............................................................................................12
ABOUT BODY COMPOSITION 13
TERM AND FUNCTION OF EACH PART 15
Basic Package ...........................................................................15
ACCUNIQ BC310 (For whole body)......................15
ACCUNIQ BC310 (For upper body)......................16
ACCUNIQ BC310 (For lower body).......................17
Options........................................................................................18
Main Body..................................................................................19
Front Part ..........................................................................19
Rear Part............................................................................21
Base Part............................................................................22
Handle electrode...........................................................22
INSTALLATION 25
Basic Installation of product .............................................25
Connecting the power supply and the scale
cable ....................................................................................25
Leveling..............................................................................25
Peripheral Device Installation...........................................26
Connecting PC................................................................26
Connecting Printer (Option) ....................................27
Connecting EXTERNAL DEVICE: .............................27
Replacing Thermal Paper ..........................................28
The trouble shooting when the thermal paper is
jammed..............................................................................28
SYSTEM SETUP 30
Entering SYSTEM SETUP .....................................................30
Menu in SYSTEM SETUP .....................................................30
Selecting a Menu in SYSTEM SETUP ............................31
Moving to SYSTEM SETUP.................................................31
Exiting SYSTEM SETUP.........................................................31
Setup ............................................................................................31
< DATE / TIME >...........................................................31
< VOLUME >...................................................................32
< CONTRAST >..............................................................33
< BACKLIGHT > .............................................................33
< ABDOMINAL > ..........................................................34
<GOAL SETTER >..........................................................34
< DATE TYPE >...............................................................35
< KEY SOUND >............................................................36
< THERMAL PRINT >..................................................36
< THERMAL LOGO > ..................................................37
MEASUREMENT AND ANALYSIS 38
Precautions for Measurement..........................................38
Correct Posture........................................................................39
How to Touch Plate Electrodes ..............................39
How to Touch Handle Electrodes .........................39
Measuring Posture........................................................40
Measuring Procedure ...........................................................41
Basic Analysis ..................................................................41

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4_CONTENTS
Analysis Using Blood Pressure Monitor/Software
Program.............................................................................47
RESULT INTERPRETATION 48
STORAGE & MAINTENANCE 52
ERROR & REPAIR 54
Kinds of Error & Repair .......................................................54
Error occurrence & Repair .................................................55
AFTER SERVICE 57
AFTER SERVICE ........................................................................57
How to contact SELVAS Healthcare .....................57
PACKING AND TRANSPORT..............................................57
SPECIFICATION 59
WARRANTY 61

User Manual BC310
INTRODUCTION_5
INTRODUCTION
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 with SELVAS Healthcare or its local distributor where is purchased. We will
provide you with detailed instructions.
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, TBW, etc. and information to BMI, PBF, BMR, abdominal analysis,
segmental analysis, etc.
Intended application location is professional healthcare facility environments, not home healthcare
environment.
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.

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6_INTRODUCTION
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.
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 IEC
60601-1:2005/A1:2012 (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 60601-1-2:2014(Electromagnetic Compatibility Requirements).
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.

User Manual BC310
INTRODUCTION_7
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
SELVAS Healthcare or our distributors.
Caution
If you have experienced any trouble with the unit, switch it off immediately, and contact
SELVAS Healthcare or its authorized dealer for assistance.
Caution
If you plan to connect any device from 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 950 or equivalent standards for data processing
equipment.
Configurations shall comply with the system standard IEC 60601-1:2005/A1:2012.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system by standard IEC 60601-1:2005/A1:2012.
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.

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8_INTRODUCTION
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.
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 IEC 60601-
1:2005/A1:2012 (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.

User Manual BC310
INTRODUCTION_9
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 60601-1-2:2014. 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

SELVAS Healthcare, Inc.
10_INTRODUCTION
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 SELVAS Healthcare.
Shipping and insurance costs for return of defective unit must be prepaid by the users.
SAFETY SYMBOLS AND INFORMATION
The International Electrotechnical Commission (IEC) has established a set of symbols for medical electrical
equipment which classifies a connection or warning 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.

User Manual BC310
INTRODUCTION_11
SYMBOL
INFORMATION
"OFF" (only for a part of equipment)
"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

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12_INTRODUCTION
SYMBOL
INFORMATION
Medical Device
Guidance for Electromagnetic compatibility (EMC)
Details about the electromagnetic compatibility (EMC) of the ACCUNIQ BC310 are given below. Before
using the ACCUNIQ BC310, be sure to read and understand the following information.
1) Guidance and manufacturer’s declaration –electromagnetic emissions
The ACCUNIQ BC310 is intended for use in the electromagnetic environment specified IEC 60601-1-
2:2014 (Fourth Edition).
2) Guidance and manufacturer’s declaration –electromagnetic immunity
The ACCUNIQ BC310 is intended for use in the electromagnetic environment specified IEC 60601-1-
2:2014 (Fourth Edition).
3) Guidance and manufacturer’s declaration –electromagnetic immunity 2
The ACCUNIQ BC310 is intended for use in the electromagnetic environment specified IEC 60601-1-
2:2014 (Fourth Edition).
4) Recommended separation distances between portable and mobile RF communications equipment and
the ACCUNIQ BC310
The ACCUNIQ BC310 is intended for use in the electromagnetic environment specified IEC 60601-1-
2:2014 (Fourth Edition).

User Manual BC310
ABOUT BODY COMPOSITION_13
ABOUT BODY COMPOSITION
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.
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.
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.
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.

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14_ABOUT BODY COMPOSITION
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, 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 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/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.
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.

User Manual BC310
TERM AND FUNCTION OF EACH PART_15
TERM AND FUNCTION OF EACH PART
Basic Package
ACCUNIQ BC310 (For whole body)
①Column
②Head Part
③Weight scale
(Base part)
④User manual &
Data management
program
⑤USB cable
⑥Serial cable
⑦Power cable and
adapter
⑧Thermal printer
⑨Roller
The model or specification are subject to change according to the market demand.

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16_TERM AND FUNCTION OF EACH PART
ACCUNIQ BC310 (For upper body)
②Head Part
③Weight scale (Base part)
④User manual & Data
management program
⑤USB cable
⑥Serial cable
⑦Power cable and adapter
⑧Thermal printer
⑨Roller
The model or specification are subject to change according to the market demand.

User Manual BC310
TERM AND FUNCTION OF EACH PART_17
ACCUNIQ BC310 (For lower body)
②Head Part
③Weight scale (Base part)
④User manual & Data
management program
⑤USB cable
⑥Serial cable
⑦Power cable and adapter
⑧Thermal printer
⑨Roller
The model or specification are subject to change according to the market demand.

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18_TERM AND FUNCTION OF EACH PART
Options
1. Data management program
This program helps managing body composition easily and
systematically. It shows the core items needed to control
body composition. The items include measured body
composition, dietary control plan, exercise plan, etc. If the
device is connected to blood pressure monitor, it also
indicates the measurer's blood pressure.
2. Automatic Blood Pressure Monitor
If SELVAS's automatic blood pressure monitor for hospital
is connected to this device, the measurer can easily check
his/her blood pressure. Especially the patient with the
hypertension can manage his/her blood pressure efficiently
through body weight control.
3. Cart for Blood Pressure Monitor
Cart is provided to place a blood pressure monitor.
Assembly manual is supplied with this cart.
4. A4 Result Sheet
The results are indicated systematically and anyone can
easily understand the results.

User Manual BC310
TERM AND FUNCTION OF EACH PART_19
5. Column
It attaches to the head part with base part.
Main Body
Front Part
ACCUNIQ BC310 (For whole body / upper body)
Thermal printer
Handle Electrode
LCD screen
Keypad

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20_TERM AND FUNCTION OF EACH PART
Handle Electrode measure the impedance by sending harmless electric current to the body. Hold them
with the hands during measurement.
LCD screen
It displays the procedure and results.
Handle Electrode
Handle Electrode measure the impedance by sending harmless electric current to the body. Hold them
with the hands during measurement.
Keypad
The keypad consists of the function keys; ‘ZERO RESET’, ‘CLOTH WEIGHT’,’WEIGHT ONLY’, ‘kg/lb’,
‘ON/OFF’, 0 to 9, Alphabet, ‘MALE’, ‘FEMALE’, ’Print’, ' ·', 'CE', '◀', '▶', 'BACK', 'NEXT' and the numeric
button.
Thermal Printer
In-built printer allows the speedy and convenient printing.
ACCUNIQ BC310 (For lower body)
LCD screen
It displays the procedure and results.
Keypad
The keypad consists of the function keys; ‘ZERO RESET’, ‘CLOTH WEIGHT’,’WEIGHT ONLY’, ‘kg/lb’,
‘ON/OFF’, 0 to 9, Alphabet, ‘MALE’, ‘FEMALE’, ’Print’, ' ·', 'CE', '◀', '▶', 'BACK', 'NEXT' and the numeric
button.
Thermal printer
Keypad
LCD screen