ACCUNIQ BC380 User Manual: Comprehensive Guide to Body Composition Analysis

Introduction

This manual provides essential information for the safe and effective operation of the ACCUNIQ BC380 device. Please read it thoroughly and keep it with the device for future reference. For any questions or issues, contact SELVAS Healthcare or an authorized distributor.

Intended Use

This device measures impedance using bioelectrical impedance analysis (BIA) to provide comprehensive body composition data, including MBF, LBM, SLM, SMM, TBW, protein mass, mineral mass, BMI, PBF, BMR, abdominal analysis, and segmental analysis. It is intended for use in professional healthcare facility environments.

Contraindications

Do not use this device if you:

Have implanted metallic materials (pacemaker, defibrillator, stent, metal suture) in the heart or great vessels.
Are equipped with devices injecting electric current (artificial heart, heart-lung machine).
Are connected to liquid-filled catheters or other conductive electronic devices.
Use electronic stimulators for various purposes.
Use devices injecting electric current (ECG, EMG, EEG).
Have been diagnosed by a doctor to be sensitive to imperceptible micro-current.

Consult a doctor before use if you:

Are using contraceptive devices.
Are pregnant.

Intended Patient Population

Age: No limit
Gender: No limit
Weight: 10 kg ~ 250 kg
Height: 50 cm ~ 220 cm
Race: No special requirements
Health: Must be able to stand and maintain the measurement posture.

Word Definitions

Warning: Indicates important information about hazards that may cause severe personal injury, substantial property loss, or damage if ignored.

Caution: Indicates important information about hazards that may cause minor personal injury or property damage if ignored.

Note: Indicates important information for installation, operation, or maintenance, not directly related to hazards.

Classification and Compliance

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 the presence of a flammable anesthetic mixture (IEC 60601-1:2005/A1:2012).
Complies with Class A for Noise-Emission and Level B for Noise-Immunity (IEC 60601-1-2:2014).

Safety Symbols and Information

The International Electro-technical Commission (IEC) has established symbols for medical electrical equipment to classify potential hazards. Key symbols include:

Type BF: Degree of protection against electric shock.
Observe operating instructions: ⚠️
General warning sign: ⚠️
General prohibition sign: ?
General mandatory action sign: ➡️
Caution sign: ?
WEEE (Waste Electrical and Electronic Equipment): Indicates proper disposal guidelines.
OFF/ON: Indicates power status for parts of equipment.
Direct current: Symbol for DC power.
Date of manufacture: Symbol indicating manufacturing date.
Manufacturer: Indicates the manufacturer.
CE mark: Indicates compliance with EU directives.
Serial No.: Unique product identifier.
EC REP: Authorized representative in the European community.
Keep dry: ?
This way up: ⬆️
Fragile: fragile
Do not use blades to open: ❌?
Handle with care: ?
MD: Medical Device.

Safety Precautions

Warning:

A microcurrent of 180µA flows during measurement. Individuals with implanted medical devices should not use this equipment due to potential malfunction.
Use only correctly wired outlets (100-240VAC) and avoid MSOs not compliant with IEC 60601-1 to prevent fire hazards.
Never plug or unplug with wet hands to reduce the risk of electric shock or device damage.
Physically disabled individuals should have assistance from a caretaker for measurements.

Caution:

Avoid storage in environments with temperatures below -25°C or above 70°C, atmospheric pressure outside 70-106 kPa, humidity over 93%, exposure to water, dust, vapor, salt, explosive gas, excessive shock/vibration, or direct sunlight.
This device requires special precautions regarding EMC and must be installed according to provided EMC information.
Cross-contamination is possible; refer to cleaning and disinfecting methods.
Measurements may be impaired near strong electrical fields (TVs, microwaves, X-rays); maintain distance or turn off such devices.
Operate only by or under supervision of qualified personnel.
If any trouble occurs, switch off immediately and contact the company or an authorized dealer.
Contact the company or dealer before connecting external devices.
Ensure connected systems comply with IEC 60601-1 and IEC 950 standards.

Prohibition:

Do not disassemble or alter the device; this can cause electric shock, injury, or affect precision.
Do not touch signal input, output, or other connectors and the patient simultaneously.
Do not attempt to adjust controls not specified in the manual.
Never pour liquid directly onto the scale platform.
Never jump on the weighing platform.

Note:

This equipment complies with IEC 60601-1-2:2014 limits for medical devices to provide reasonable protection against harmful interference.
Place the weighing platform on a level and stable surface.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Consult a physician or trained health professional for result interpretation.
In case of patients with certain diseases, estimates might differ.
Incorrect operation or failure to maintain the unit absolves the manufacturer of responsibility for non-compliance or damage.
This manual is for informational purposes and is not a substitute for professional medical advice.
Defective units must be packed in replacement cartons for return, with shipping costs prepaid by the user.
Connect the earth terminal to prevent electric shock.
Use only the provided power cable and adapter.
Turn off the main power switch before unplugging the power cord.
Any serious incident must be reported to the manufacturer and the competent authority.

Guidance for Electromagnetic Compatibility (EMC)

Avoid using this equipment adjacent to or stacked with other equipment. If necessary, observe both to ensure normal operation. Using accessories other than those specified may increase emissions or decrease immunity. Portable RF communications equipment should be used at least 30cm (12 inches) away from the device. Details on EMC compliance for the ACCUNIQ BC380 are provided below, adhering to IEC 60601-1-2:2014 standards for emissions and immunity.

About Body Composition

Body composition refers to the balance of moisture, protein, fat, and minerals in the human body. Maintaining these components in a healthy ratio is crucial for overall health. Imbalances can lead to obesity, nutritional deficiencies, and osteoporosis.

What is Obesity?

Obesity is diagnosed using various methods, primarily focusing on Fat Mass. It can be categorized as 'apparent obesity' (overweight for height) or 'hidden obesity' (high body fat percentage despite normal weight). While BMI is a common indicator, body fat percentage measured by BIA provides a more accurate diagnosis.

Necessity for Body Composition Analysis

Analyzing body composition helps understand basic health conditions and prevent diseases by identifying imbalances. It serves as a screening tool for health management.

Indicators for Obesity Judgment

Percentage of Body Fat (%): Ratio of body fat to body weight.
Body Mass Index (BMI): Calculated as weight (kg) / height (m²).
Obesity Degree (%): Compares current weight to standard weight.

Abdominal Obesity

Abdominal obesity is determined by the location of fat accumulation (subcutaneous vs. visceral fat) and the Waist Hip Ratio (WHR).

Segmental Analysis

This device analyzes body fat mass and soft lean mass in five segments (arms, legs, trunk) to evaluate symmetry and progress in fitness or rehabilitation.

Safety Management

Device safety and reliability are ensured by following these precautions:

Only trained and certified specialists should operate the device's internal components.
Do not adjust controls not specified in the manual; contact service for changes.
If a problem occurs, turn off the power immediately and contact service.
Avoid storage and use in extreme temperatures, high humidity, dusty, or unstable environments.
Ensure the device is grounded.
Use only the provided power adapter and cable.
Turn off the power before unplugging the cord.
Do not operate with wet hands.
Turn off the main device power before connecting peripherals.
Connect the equipotential terminal to the grounding wire to prevent electric shock.
Get inspection service before using a device that has been exposed to foreign substances or special environments.
When reusing after a long period, check for abnormalities.
Observe general electrical device precautions and manual instructions.

Cautions:

Use only the manufacturer-provided cable for power supply.
Keep a sufficient distance from or turn off devices generating strong electric fields (TVs, microwaves, X-rays) to prevent measurement errors.
This device complies with IEC 60601-1 and IEC 60601-1-2 standards.
Dispose of the device according to medical device regulations.

Name and Function of Each Part

Main Components

The basic configuration includes:

Main body: The primary unit housing the display and electronics.
User manual: This document.
Power cable and adapter: For power supply.
USB cable: For PC connection.
M6 bolts: For assembly/disassembly.
4mm hexagon wrench: For adjustments.
Body hinge cover: Protective cover.
A4 result sheet: For printing measurement results.

Options

Data Management Program: Software for managing body composition data.
Result Sheet for Children: Specialized report for children's growth status.
Automatic Blood Pressure Monitor: Connects to measure blood pressure.
Thermal printer: For quick printing.
Thermal paper: For the thermal printer.
Bluetooth Dongle: Enables wireless PC communication.
Ultrasonic Height Meter SM104: For accurate height measurement.

Device Appearance

Front Part: Features a Color LCD (TFT monitor) with a built-in touch screen for data input, measurement display, and results. Includes hand electrodes for current input.

Base Part: Contains foot electrodes for contact with the user's feet to measure body impedance.

Rear Part: Includes ports for Power switch, Adapter, PC Connection (USB), Height Meter, Wi-Fi printer, USB memory, Bluetooth, Printer, and Blood Pressure Monitor.

Caution: Do not touch the patient while operating the rear panel. Ensure patients do not touch the rear side during measurement. Use FAT32 file system for USB memory.

Installation

Power Connection

Connect the provided adapter to the Adapter port on the rear of the device and turn on the power switch.

External Connection

Caution: Connect only specified or compatible items. Contact the manufacturer in case of a cybersecurity breach. Bluetooth communication may be affected by nearby wireless systems.

PC Connection - Wired (USB Cable)

Connect the device's USB (B) port to a computer's USB port using a USB cable. Ensure the USB driver is installed and use a cable shorter than 3m (121 inches).

PC Connection - Wireless (Bluetooth)

Connect the optional Bluetooth Dongle to the Bluetooth terminal on the rear side. Refer to the ACCUNIQ Manager manual for setup.

How to Connect Printer

Direct Connection: Connect an A4 printer to the device's USB (A) port with a printer cable.

Computer Connection: Connect the device to a computer via USB (B) port, then connect the printer to the computer. This allows printing via the computer.

Note: For data management and printing via computer, ensure the Data Management Program is installed. Professional consulting software offers additional print options.

Blood Pressure Monitor Connection

Connect the device to a SELVAS Healthcare Blood Pressure Monitor (e.g., BP500, BP210, BP250) using the provided RS-232C cable (within 1.5 meters).

How to Replace Thermal Paper in the Thermal Printer

Replace thermal paper with the power on. Open the printer cover, remove the old paper, insert new paper, and close the cover. Use the FEED function (password '5555') to feed paper or the CUT function (password '8888') to cut it.

Note: Do not pull the paper during printing. Operation during printing may cause device failure.

System Setup

The 'User Setup' feature allows customization of the device's operating environment. Access it by pressing the icon on the initial screen and entering the default password '0000'.

Setup Menu Icons:

1. Basic Settings: Configure Date/Time, Date format, measurement units (kg/cm), Volume, Measuring Music, Language, Password, and Non-member use.
2. Data Management: Check, print, delete data; copy data to Excel; perform data backup/restore/merge.
3. Printer / Printing: Set up printers, automatic printing preferences, print position, and search/connect printers.
4. Results: Select ACCUNIQ exclusive paper or A4, change logo, set Adult/Child outcome settings, and abdominal obesity analysis settings.
5. Communication: Configure Internet connection (Wi-Fi/Ethernet) for cloud service access and select programs (ACCUNIQ Manager/Dashboard) with connection methods (Bluetooth/USB).
6. Weight: Select weight measurement/input, and perform weight/height correction.
7. Management Options: Use optional equipment, set standard ranges, and configure Cloud Settings (server address, time zone).
8. Display: Set result display format and Lock Screen function.
9. Customer Support: Access Problem Solving and Product Information (software version, serial number).

Note: Time zone settings in Cloud Settings must be accurate for proper synchronization.

Measurement and Analysis

Precautions for Measurement

Ensure accuracy by following these guidelines:

Measure on an empty stomach, 3-4 hours after a meal. Avoid caffeine and alcohol before measurement. Drink water 2 hours prior.
Maintain stable body fluid distribution; measure 3-4 hours after bathing, sauna, or exercise, or before activity.
Wear light clothing.
Stand still for 5 minutes before measurement to stabilize body water distribution.
Ensure electrodes (hand and foot) are clean and free of foreign objects.
Allow body warmth to stabilize at room temperature (approx. 20°C).
Measure at a consistent time daily for accurate trend analysis. Morning measurements are recommended for those who stand for long periods.
Empty the bladder before measurement.
Maintain correct measurement posture and method.

Reproducibility is key for tracking changes. Maintaining consistent conditions (food intake, time elapsed, activity) ensures reliable trend analysis.

Correct Measuring Posture

How to Stand on a Scale with a Foot Electrode:

Ensure foot electrodes are clean.
Remove socks or stockings.
Ensure hands and feet are clean.
Stand with feet contacting the foot electrodes, ensuring no clothing interferes.

Correct Measuring Posture:

Step onto the scale, hold the hand electrode correctly, keeping arms at a 30° angle to the body.
Remain still and silent until measurement is complete.
Ensure continuous electrode contact; do not bend or shake arms.

How to Hold the Hand Electrode:

Ensure hands are clean.
Hold the electrode so palms and fingers touch the entire surface.

Note: Incomplete electrode contact can lead to unreliable results or measurement interruption. Ensure all 8 electrodes are properly touched.

Measurement

Basic Analysis:

Stand on the scale. Weight measurement begins automatically. Remain still.
After weight measurement, select member or non-member examination.
Enter personal information: ID, date of birth, gender, and height.
Start measurement: Fix foot position, then hold hand electrodes correctly with all fingers. Keep arms and trunk at a 30° angle.
A "Measurement starts. Don't speak or move." message appears.
Measurement progresses, showing "Test is in Progress. Please Wait.".

Note: If measurement is wrong (e.g., "Impedance is out of the measurement range"), re-measure following posture guidelines. Three consecutive errors may require referring to 'Problem Solving'.

View Results

After analysis, results are displayed. You can view summarized results or details.

Note: If the result sheet does not print, check printer connection and power.

View via Mobile Device (QR Code): Pressing the QR code on the result screen enlarges it for scanning with a smartphone/tablet app to view results.

View via Mobile Device (App): Download the 'ACCUNIQ Connect' app from app stores. Scan the device's QR code to sync data to the app for cloud access, data checking, and expert consultation.

Restart: Press 'Exit' after viewing results to return to the initial screen.

Logging in and taking measurements with the ACCUNIQ Connect app

Save test results to your smartphone using the ACCUNIQ Connect app. Install the app from the Google Play or iOS app store, sign up, and then log in. Scan the device's QR code to load your information into the app. Confirm the imported data and proceed with measurement.

Note: ACCUNIQ Connect membership allows cloud access and professional review. Using ACCUNIQ Manager may disable the 'Login with ACCUNIQ Connect' option.

Analysis Using the Ultrasonic Height Meter

Connect the optional Ultrasonic Height Meter (SM104) and set 'Use Height Meter' to ON in Setup. The device will prompt for height measurement after stepping on the scale. Personal information entry follows.

Note: Ensure the height meter is properly connected; otherwise, a message will appear.

Analysis Using a Blood Pressure Monitor

Connect a SELVAS Healthcare Blood Pressure Monitor to analyze body composition and blood pressure simultaneously. Measure blood pressure first, then body composition. Results are displayed together. A confirmation prompt appears before saving BP data.

Note: Select 'Yes' to save BP data with composition results; 'No' to exclude it.

Result Sheet Interpretation

The device provides detailed analysis data, including body type, obesity evaluation, nutritional status, and segmental evaluation.

Body composition result sheet

Personal data: Includes user name, ID, date, height, weight, age, and gender for reliability checks.
Logo: Hospital or clinic information can be displayed.
Body Composition Analysis: Breaks down the body into Total Body Water, Protein, Minerals, and Fat Mass.
Weight: Total body weight.
Fat Free Mass (FFM): Body weight minus body fat.
Soft Lean Mass (SLM): Muscle composition.
Total Body Water (TBW): Intracellular and extracellular water.
Protein: Indicator of cellular nutritional status.
Minerals: Components of bones and soft tissues.
Fat Mass (FM): Subcutaneous and visceral fat.

Skeletal Muscle / Fat Analysis

Weight: Standard weight calculation based on BMI, with a normal range of ±15%.
Skeletal Muscle Mass: Muscle attached to bones, about 60% of SLM.
Fat Mass (FM): Essential and reserve fat, used for obesity diagnosis.

Obesity Analysis

Body Mass Index (BMI): Weight (kg) / height (m²).
Percentage of Body Fat (PBF): Ratio of body fat to body weight. Normal ranges provided for men/women and children.
Waist Hip Ratio (WHR): Ratio of waist to hip circumference, indicating abdominal obesity.

Comprehensive Evaluation

Body Type: Classified based on weight, skeletal muscle mass, and body fat mass.
Biological Age: Age estimate based on body composition, used as a health reference.
Basal Metabolic Rate (BMR): Minimum energy required for life functions, calculated using Katch-McArdle's formula.
Total Daily Energy Expenditure (TDEE): BMR multiplied by physical activity level.
Obesity Degree: Calculated based on current vs. standard weight.
Total Score: Detailed assessment for physical condition.

Nutritional and Cellular Health Assessment

Evaluates protein, minerals, and body cell mass for nutritional status and cell health.

Body Balance Assessment

Assesses balance between upper/lower body and left/right sides.

Body Composition Chart

Visualizes FMI, FFMI, BMI, and PBF, indicating user's condition relative to muscle-developed body types.

Skeletal Muscle Mass Index

SMI: Index of skeletal muscle mass to height (kg/m²) for sarcopenia evaluation.
ASMI: Percentage of muscle mass in extremities relative to body weight.

Waist Circumference (WC)

Estimated based on visceral fat level, with standard values provided for different countries and genders.

Waist Hip Ratio (WHR)

Ratio of waist to hip circumference, used to judge abdominal obesity.

Visceral Fat Level (VFL)

Classifies visceral fat levels from 1 to 20 based on fat distribution.

Visceral Fat Area (VFA)

Measures abdominal viscera fat area (cm²); excessive amounts can lead to adult diseases.

Visceral Fat Mass (VFM)

Estimates fat located in the intestines.

Body Cell Mass (BCM)

Indicator of cell health, proportional to protein and intracellular water.

Impedance

Provides impedance measurements at different frequencies (5K, 50K, 250K Hz) for research and operational evaluation.

Blood Pressure Result

Displays blood pressure results when connected to a BP monitor, judged as high if systolic ≥ 140mmHg or diastolic ≥ 90mmHg.

QR Code

Scan with the ACCUNIQ app to manage test result history and access data.

Result Sheet for Child (Option)

Provides a specialized result sheet for children, including personal data and body composition analysis, with specific PBF ranges for boys and girls.

Storage and Maintenance

Storage

Store the device in a cool, dry place away from direct sunlight, moisture, dust, and extreme temperatures. Avoid unstable locations or those subject to vibration or impact. Ensure proper grounding. Do not place objects on the device or subject it to strong impacts. Do not disassemble or modify the device. Use the original packaging for transport.

Maintenance

Cleaning: Use a soft cloth. Avoid volatile solvents. Wipe out dust regularly.

Disinfection: Use alcoholic water or glutaraldehyde disinfectant solution, then wipe with a soft lint. Always refer to "SAFETY PRECAUTIONS".

Caution: Use sterile safety equipment (gloves) when cleaning electrodes.

Problem Solving

Error Occurrence and Actions

Impedance out of range: Clean electrodes, check contact, ensure correct posture. If persistent, contact service.
Body fat % out of range: Wipe hand electrodes clean. If persistent, contact service.
Measurement not proceeding: Ensure correct height/age input.
Weight not measured: Ensure correct weight input, avoid movement during measurement.
Not connected to analyzer: Check internal communication; power cycle the device. If persistent, contact service.

Error Code Occurrence & Actions

38001: Electrode/parts dirty or faulty. Clean electrodes, check contact, ensure correct posture.
38003: External influence causing impedance error. Check installation environment.
38004: Impedance out of range. Clean electrodes, check contact, ensure correct posture.
38005: PBF out of range. Clean electrodes, check contact, ensure correct posture.
38006: Continuous error (3 times). Step off, try again.
38007: Disconnected boards. Contact service.

Measurement Error Occurrence and Actions

High/low body fat %: Ensure proper hydration, avoid movement, keep areas clean.
Measurement not performed: Check electrode handle connection. If persistent, contact service.

Problems in Use

Check measurement items. If issues persist, contact the vendor with model name, serial number, purchase date, and defect description. SELVAS Healthcare provides trained after-sales service.

Packing and Transportation

Repack the device in its original packaging. Turn off power, disconnect peripherals, disassemble in reverse order, and transport with care to avoid shocks.

Specifications

General

Model: ACCUNIQ BC380
Measuring Method: BIA via tetra-polar electrode method (8 touch electrodes)
Frequency Range: 5, 50, 250 kHz
Measurement Area: Whole body and segments (arms, legs, trunk)
Result Items: Comprehensive body composition analysis, skeletal muscle/fat analysis, obesity analysis, segmental analysis, body water analysis, cumulative changes graph, comprehensive evaluation, nutritional/cellular health, body balance, body composition chart, research content (SMI, ASMI, WC, WHR, VFL, VFA, VFM, BCM), impedance, blood pressure result, QR code. Also includes specific results for children.
Measured Current: Within 180µA ±15
Power Supply: Input AC 100-240V~, 50/60Hz; Output DC 12V, 5A, 60W MAX.
Display: 7-inch wide color LCD.
Input Device: Keypad, Touchpad.
Transmission Device: USB port, RS-232C, Bluetooth (Option).
Printing Device: USB port, Thermal print (Option).
Size: 641×436×1029mm (W×D×H).
Weight: Approx. 18 kg (main unit).
Measurement Time: Approx. 30 seconds.
Input Height: 50 ~ 220 cm.
Input Weight: 10 ~ 250 kg.
Measurement Age: 1 ~ 99 years old.
Range of Use: Temp +5 to +40°C, Humidity 15-93% RH, Pressure 70-106 kPa.
Range of Storage: Temp -25 to +70°C, Humidity <93% RH, Pressure 70-106 kPa.
Software Name/Version: BC380, BC380.EN.1.0.00.

Blood Pressure Monitor

Compatible models: SELVAS Healthcare BP500, ACCUNIQ BP210, ACCUNIQ BP250. Specifications for each are provided.

List of Supported Printers

Samsung, Brother, HP models listed.

PC Specification

Recommended PC specs: Quad-core CPU, 8GB RAM, 256GB disk space, Windows 7/8.1/10, 1280x800 resolution, USB ports.

Expected Service Life

Approximately 5 years.

Warranty

Name of Device: Body Composition Analyzer

Name of Model: ACCUNIQ BC380

Serial Number: [Field for Serial Number]

Period of Warranty: Within 1 year from the date of manufacture/purchase.

Customer/Dealer Information: Fields for name, address, and telephone number.

Note: Ensure all warranty details are completed. Keep the warranty safe as it is not reissued.

Periodic and Daily Check Lists

The manual includes checklists for periodic and daily inspections covering visual, mechanical, electrical, and general aspects of the mainframe and accessories to ensure proper functioning and maintenance.

Contact Information

SELVAS Healthcare, Inc.

HEADQUARTERS: 155, Sinseong-ro, Yuseong-gu, Daejeon, 34109 Republic of Korea

Tel: +82 42 879 3000 | Fax: +82 42 864 4462

Service Center: Tel +82 42 879 3000

When reporting a failure, please check the user manual first, then provide model name, failure status, address, name, phone number, and location.