Mediana i20 User manual

USER MANUAL
Body Composition Analyzer

About this manual
This manual explains how to install and useI20. Please refer toWARNING and CAUTION signs where users
need to be extra careful while using I20. Before using the product, users should carefully read this manual
including precautions.
Trademark
The name of the product in this manual may be the trademark or the registered mark of the company.
If there is any problem with I20 or you have clinical questions, contact us.
Manufacturer Mediana Co., Ltd.
132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: [phone] (82) 33 742 5400
OBELIS S.A Bd. Général Wahis, 53, 1030 Brussels, Belgium
MEDIANA reserves the copyright of this user’s manual. Any contents or text of this manual can be
modified without prior notice to the company. If you have any inquiries regarding this manual, please
contact service center. Any manual containing misprints shall be sent again.
Document number : A7684-0
Revision date : 2019-10
Copyright © 2019 All rights reserved Product Warranty

Product Name
I20 (Product number : )
Warranty
1 year from date of purchase
Purchase date
. . .
• The warranty is not valid if your issue falls into any of the following circumstances.
- If non-MEDIANAstaff or service provider performs unauthorized repair, installation, transport, or
maintenance
- When the product is damaged by other equipment
- Damage by user's carelessness
- If maintenance or repair is not performed with MEDIANA-authorized equipment
- If you arbitrarily change the equipment or use non-MEDIANA-authorized components
- Damage caused by natural disasters such as accidents, earthquakes or floods
- Damage after the expiration date specified in this manual
- In case of damage due to failure of the proposed maintenance method
• This warranty applies only to the hardware of this product and does not apply to loss or damage from
included components or from improper operation.
• If any problem occurs with I20, contact local dealer.
• This equipment meets the EMC standard-IEC 60601-1-2.

1.Description 8
1.1. Basic Component 8
1.2. Install the product 9
1.3. Connecting the A4 Printer 11
2.Using Product 12
2.1. Name and Characteristics of Parts 12
2.2. Safety Precautions 15
2.3. Power On/Off 18
2.4. Body Composition Measurement 19
2.5. Checking Result 22
3.Setting 23
3.1. Menu 23
3.2. Database result 24
3.3. Measurement 27
3.4. Print 28
3.5. System setting 29
4.Service 32
4.1. Problem solution 32
4.2. Self-resolution 32
4.3. Recycling and disposal 33
4.4. Product return 33
4.5. Transportation and Storage 34
4.6. Maintenance 35
4.7. Regular safety check 36
5.Specifications 37
6.Manufacturer’s EMC Declaration 38
Body Composition Analyzer
20
Contents

Precautions for use
It is a description about cautions required for normal product use. Refer to WARNING and CAUTION in the
chapters of this manual for more information.
Note! Carefullyreadandfollowtheprecautions andproductspecifications specified in this manualbefore using
the product. (N0001)
WARNING
Indicates possible risks of death, injury or side-effects or potentially serious to the patientor user.
• Use grounding for medical equipment when using commercialAC power. It may cause short circuit
hazards.(W0001)
• Do not use unauthorized component or option to prevent accidents.(W0002)
• Please read this manual thoroughly provided with related or optional components prior to operation.
This manual may not contain warnings about individual components.(W0003)
• Unauthorized disassembly or cover opening may cause electric shock orfire hazards. Unauthorized
repair or modifications to the product without manufacturer’s approval is not covered by the warranty.
(W0004)
• Connect the product to the designated power source to prevent electric shock or fire hazards.(W0005)
• Make sure that the equipment is in safe condition before use.(W0006)
• Liquid spill may cause electric shock or fire hazards, if it occurs, immediately unplug, wipe it off and
contact service center.(W0007)
• Turn off the power and unplug powerplug to prevent electric shock before maintenance.(W0008)
• If it smells suspicious or emits smoke, immediately turn off the power and unplug power cord.(W0009)
• Don’t use damaged cable, device, or connector to prevent accidents.(W0010)
• Don’t install the equipment where it is difficult to unplug the power cord.(W0011)
• Don’t plug or unplug power cord with wet hands. It may cause a danger of electric shock.(W0012)
• Use extension cable or outlet with sufficient power capacity when using outlet with multiple terminals.
(W0013)
• Be sure not to let this product in direct contact with other electronic devices in power. It may cause a
spark hazard.(W0014)
• Use the model adapter provided by MEDIANA. Use of other adapters may cause equipment
malfunction.(W0025)

CAUTION
Indicates conditions or action that could cause damage to the equipment.
• Be sure to read the instructions before using the equipment for safety. (C0001)
• Equipment may not be operated properly if it is operated or stored in the environment not
recommended by MEDIANA.(C0002)
• Dropping or hitting of the equipment may cause product failure. Do not use the product in failure.
(C0003)
• Do not place anything on the equipment. There is a risk of equipment damage.(C0004)
• Do not operate near large equipment using switching relay. If the equipment experiences external
interference, it may cause inaccurate measurement analysis. (C0005)
• If the equipment shares the same electrical outlet with other devices which could cause electrical
interference, set them off on separate supply sources.(C0006)
• Turn on the power of other inspection devices first, when connecting I20to the inspection
devices. If you want to turn off I20, power off the inspection devices first this time, then I20later.
Electrical shock of the equipment can be minimized. (C0007)
• If the hand electrode is bent over its normal range of use or rotates excessively up, down, left and
right, it may cause breakage issues. Do not apply excessive force to the hand electrode. (C0009)

1. Description
1.1. Basic Component
8
1. Description
Body composition analyzer
I20 is a body composition analyzer which determines body composition parameters based on bioelectrical
impedanceanalysis(BIA).Thisdevicecalculatesandestimatesbodycompositionparametersbyusingweight
and segmental impedance of each frequency. Body composition analysis results may be of value to health
care professionals in their management environments. The device is not intended to diagnose or treat any
medical condition.
1.1.Basic Component
The following are the basic components of the product. Make sure you have all the components.
I20 Body CompositionAnalyzer
Power adapter (DC 12V, 5.0A)
Power cable (AC 250V, 10A, 1.8m)
User Manual& Body Composition Result Interpretation
A
B
C
D
A
B
C
D
User
Manual
BodyComposition
ResultInterpretation

1. Description
1.2. Install the product
20 Body Composition Analyzer User Manual
9
1.2.Install the product
Check whether there is damage to the box. Please stop unpacking and contact local dealer or nearby service
center immediately if signs of damage are spotted on the equipment or accessories. Also refer to the
maintenance section.
A. After unpacking the box, remove the packing pad and take out the device.
B. Rotate the handle to the front and then raise the upper body with the button of the lower body
pressed.
1
2

1. Description
1.2. Install the product
10
D. Make sure the air bubble in the level indicator is centered by turning the height adjustment
screws.
Equipment should be leveled and installed on flat floor. If it is not leveled, it may cause a risk of
stumbling injury to the examinee, product damage, or inaccurate measurement control.
E. After connecting the adapter to AC power, plug the AC power plug into the outlet. Connect
the adapter to the power input terminal on the back of the product.
CAUTION
• While in use, connection should not be made through electrical outlets that use switches, as it
may lead to the unexpected turning off of the equipment. (C0010)
WARNING
• To maintain measurement accuracy or performance and to prevent failure or damage, it should
be protected from excessive moisture, such as direct exposure to rain. (W0015)
1
2
3
Height
Adjusting screws
Horizontal
State (O)
Power input
Terminal

1. Description
1.3. Connecting the A4 Printer
20 Body Composition Analyzer User Manual
11
1.3.Connecting the A4 Printer
①Power off the equipment. Connect the printer USB cable to USB private port to back of the
product.
②Connect the printer private USB cable to port on back of the printer.
③Turn on the equipment and printer. Check the printer connection.
④If printer is connected successfully, printer symbol ( ) will appear when button at the top of
the screen is pushed.
• Available printers can be checked on the manufacturer's website. (N0004)
• Depending on the region, the region code can be added. (N0002)

2. Using Product
2.1. Name and Characteristics of Parts
12
2. Using Product
2.1.Name and Characteristics of Parts
A. Front
B. Back
Touch LCD
Hardware button
Rod electrode
rotating unit
Hand electrode
rotation unit
Hand electrode
contact unit
Lower body joint unit
(For packaging)
Weight measurement
and Foot electrode
Horizontal
Adjustment unit
Test Port
Main power button
RS-232 Port
Power input unit
Printer Private USB Port
USB Port

2. Using Product
2.1. Name and Characteristics of Parts
20 Body Composition Analyzer User Manual
13
C. Hardware Button
Button
Function
Power
• If you press it for more than1 second when power is off, the power indicator turns green
and the power is on.
• If it is pressed for more than 2 seconds with power on, the power is turned off and the light
changes to red.
Number
• You can enter number in weight, personal information and menu.
Gender
• You can choose gender as male (M), female (F) when entering personal information.
Point
• You can enter decimal point when entering personal information.
Enter
• You can complete the entry after entering the information.
Delete
• You can delete the entered information one space at a time.
Menu
• You can enter the menu.
Light
• Red indicator : Ready, Green Indicator : System operating
Blind
• You can hide sensitive measurement results displayed on the screen.
• You can disable the blind function by pressing the button once again while the blind function
is on.
Number
Point
Light
Power
Gender
Enter
Menu
Blind
Delete

2. Using Product
2.1. Name and Characteristics of Parts
14
○ Mechanical Feature
• The size of this product is 360 (W) X 559 (L) X 992 (H) (mm). It allows for portable use and easy
transport, with a simple-push-button-fold system and hand grip.
○ Electrical Feature
• Adapter power input: AC 100-240V, 50-60Hz, 1.5A (1.5-0.7A)
• Adapter power output: DC 12V. 5.0A
○ Display
• This product uses 4.3-inch color LCD touch screen. This enables simple and easy operation.
• Refer to the operation check section of the service manual for details on how to use the touch
screen. If there are any problems with key-pad operation and touch screen selection, contact local
dealer or service department. (N0005)
○ External Interface
• This product supports RS-232 and USB interface. It offers USB ports to support printer and barcode
reader connections. Update of main programs, or back-up & restoring measurement data and exporting
to PC are also available through USB interface.

2. Using Product
2.2. Safety Precautions
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15
2.2.Safety Precautions
A. Display Item
Symbols
Description
Symbols
Description
Manufacturer
Manufacture Date
Product serial number
Product configuration
number
Connection type: USB
Connection type: Printer
private USB
Serial Port
B. Safety Sign
Symbols
Description
Symbols
Description
Warning
Power on
Caution
Power off
AC power supply
BF type mounting portion
DC power supply
EU representative
information
Follow guidelines for proper
disposal
See user's Manual
Storage direction
Transport / Storage
pressure
Moisture blocking
Transport / Storage
humidity
Handle with care
Transport / Storage
temperature

2. Using Product
2.2. Safety Precautions
16
C. Product Category
Protection type against electric shock
CLASS I
Degree of protection against electric shock
BF type
Degree of protection against immersion
Same degree of water protection as shell coverings
that offer no liquid protection, IPX0.
※This device is not suitable for use in the presence of flammable materials.
D. Functions for safe use
The intended operator of this product should have received qualified product training, and the main functions
that can be used safely are as follows.
Weight measurement
Weigh the weight using the load cell and check theresult on LCD.
Body impedance
measurement
Body impedance is measured by sending a weak, harmless electrical
current through the hands and foot electrodes. Body composition results
can be checked on the LCD screen after measurement.
E. Compliance
Classification
Standard
Title
General
93/42/EEC as amended by
2007/47/EC
Medical Device Directive (forEU)
IEC 60601-1:2005+A1:2012
EN 60601-1:2006+A1:2013
Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
ISO 13485:2003/Cor1:2009
EN ISO
13485:2012/AC:2012
Quality systems - Medical Devices - Requirements
for regulating purposes
EMC
IEC60601-1-2: 2014
EN 60601-1-
2:2007/AC:2010
Medical electrical equipment –Part 1-2: General
requirements for basic safety and essential performance
–Collateral standard: Electromagnetic compatibility –
Requirements and tests
Risk Analysis
EN/ISO14971:2012
Medical Electrical Equipment - Software Safety
Requirements
Programmable
Electrical
Systems
IEC 62304:2006+A1:2015
EN 62304:2006/AC:2008
Medical device software –Software life cycle processes
Usability Study
IEC 60601-1-
6:2010+A1:2013
EN 60601-1-6:2010
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
- Collateral standard: Usability
IEC 62366:2007+A1:2014
EN 62366:2008
Medical devices -Application of usability engineering to
medical devices
Package
ISTA: Pre-Shipment Test
Procedures (Procedure 2A,
2014)
Pre-Shipment Test Procedures (Package)
Scale
OIML R76-1:2006
Non-automatic weighing instruments
Part 1: Metrological and technical requirements - Tests
OIML R76-2:2007
Non-automatic weighing instruments
Part 2: Test report format

2. Using Product
2.2. Safety Precautions
20 Body Composition Analyzer User Manual
17
WARNING
• Measurement is prohibited for individuals with an internally implanted Pacemaker. (W0016)
• Measurement is prohibited for those whose use of electrodes may cause skin problems. (W0017)
• Jumping or playing on the footplate is prohibited due to possible personal injury. (W0018)
• Pregnant women need to consult with doctors or experts first before measurement. (W0019)
• Ask help from the manager in charge, if you are a child or having difficulty measuring yourself.
(W0020)
• Measurement is prohibited for individuals with any kind of contagious disease or whose infected
wound can have direct electrode contact.(W0021)
• Measurement result of this product is for reference purpose only and should not be used for treatment
purposes based on the user’s unprofessional judgment. Consultation with doctor or certified specialist
is required for accurate result analysis.(W0022)
MeasurementRecommendation
• Observe the following for accurate measurement.(N0006)
• Recommended to measure on an empty stomach.
• Recommended to measure after urination and excretion.
• Recommended to measure before taking a bath.
•Recommended to measure before exercise.
•Recommended to measure as regularly as possible.
• Stand upright for about 3 minutes before taking the test for more reliable results.
•Excessively high or low body temperature can cause measurement errors in composition analysis.
•Wear light clothes and take off jewelry before measurement.
• Dry limbs or excessive calluses may hinder accurate measurement. Wet-wipe your palm and sole
before measurement.
•Large surgical scars or skin problems may lead to reduced analysis accuracy.
•Operation at the altitude of higher than 2,000 meters may affect weight measurement.

2. Using Product
2.3. Power On/Off
18
2.3.Power On/Off
Make sure that the product is working properly, before using it. The following explanation helps with how to
operate the power button.
A. Power On
With the switch on the back of the product turned on, press power button for more than 1 second.Then,
it starts and the loading screen will be displayed after the normal operation test.
• If the power doesn't turn on, check that the power cord is fully inserted into a grounded outlet and
that DCconnector jack of the adapter is fullyinserted into the power input socketof the equipment.
(N0007)
B. Power Off
Press the power button for more than 2 seconds with it turned on. So the equipment will be shut down.
To turn off the switch on the back of the product will cut power to the device.
CAUTION
• Please do not put anything on the device to avoid malfunction of weight measurement. (C0028)
• When the power is turned on, the normal operation test (POST) is executed automatically to check
that the circuit or function is working properly. For running the normal operation test (POST) you
should check whether the screen is on or the startup sound is heard. If the screen doesn’t work
properly, don’t use the equipment and immediately contact local dealer or service center. (C0011)
• When finished with using the equipment, press the power button to turn off the equipment first, then
turn off the power by pressing the switch on the back of the unit. If the power is turned off suddenly
while the screen is on, the equipment may be damaged.(C0012)
• Keep the switch turned off, if the equipment will not be used for a long period of time.(C0013)

2. Using Product
2.4. Body Composition Measurement
20 Body Composition Analyzer User Manual
19
2.4.Body Composition Measurement
1. When you step on the weighing platform while [the home screen] is turned on, it will automatically start
to measure weight first.
- If you take your socks off and stand on your feet, you can easily proceed with body composition
measurement after measuring weight.
2. Select how to enter member ID (Existing member, Registration, Non-member) on [the information input
screen].
- If you press [Non-member] button, follow step 4. Results are not saved in non-member use of the
equipment.
3. Enter ID using [ID Input Keypad] or [Button Input] and press .
- ID can be input using up to 20 characters of English alphabet or symbols.
Enter ID
Weight
Previous measurement
result check button
System & Measurement
Information Confirmation
Button
Enter ID
(For existing members)
Existing member
start button
Non-member button
New registration button
Inputted ID Enter button
Keypad Close Key
CaseTransition Key
Special symbol
Transition Key

2. Using Product
2.4. Body Composition Measurement
20
4. Input necessary user information for measurement andpress .
- For non-member use, select Gender and enter Height andAge.
- It shows up saved information for existing members. Personal information can be changed, if needed.
[User information input screen]
• Gender: Touch input or Press , of [Button Input].
•Height:Touch inputbox andEnteritusing[NumericKey] and button to the first digit decimal place.
•Age: Touch input box and Enter it using [Numeric Key] by integer.
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