MS4971 Stand-on Floor Scale User Manual REV 4 May 2021

Explanation of Graphic Symbols on Label/Packaging Caution, consult accompanying documents before use

Separate collection for waste of electrical and electronic equipment, in accordance with Directive 2002/96/EC

Manufacturer of medical device

Manufacturing year of medical device

Carefully read user manual before installation and usage, and follow instructions for use.

Medical electrical equipment with Type B applied part

Device catalogue number

Authorized representative in the European Community

Manufacturer's batch or lot number

Device is a medical device

Serial number

Unique Device Identifier

Device conforms to 93/42/EEC as amended by 2007/47/EC Medical Device Directive. Four digit number refers to Notified Body. Device complies with International Organization of Legal Metrology (Class III) requirements (verified models only) Device complies with EC directives (verified models only) M: Conformity label in compliance with Directive 2014/31/EU for non-automatic weighing instruments 18: Year in which conformity verification was performed and the CE label was applied. (ex: 18=2018) 0122: Refers to Notified Body for metrology

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Copyright Notice Charder Electronic Co., Ltd. No.103, Guozhong Rd., Dali Dist., Taichung City 41262 Taiwan Tel: +886-4-2406 3766 Fax: +886-4-2406 5612 Website: www.chardermedical.com E-mail: [email protected] Copyright© Charder Electronic Co., Ltd. All rights reserved. This user manual is protected by international copyright law. All content is licensed, and usage is subject to written authorization from Charder Electronic Co., Ltd. (hereinafter Charder) Charder is not liable for any damage caused by a failure to adhere to requirements stated in this manual. Charder reserves the right to correct misprints in the manual without prior notice, and modify the exterior of the device for quality purposes without customer consent.

Charder Electronic Co., Ltd. No. 103, Guozhong Rd., Dali Dist., Taichung City, 41262 Taiwan

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CONTENTS

I. Safety Notes ... 5 A. General Information ... 5 B. EMC Guidance and Manufacturer's Declaration ... 8 II. Installation...12 A. Assembly ...12 B. Inserting Batteries ...12 C. Using Adapter ...13 D. Attaching Height Rod to Column ...14 E. Attaching Thermal Printer ...16 III. Indicator ...17 A. Indicator and Key Functions ...17 B. Display layout...18 IV. Using Device ...19 A. Basic Operation ...19 B. Hold ...19 C. Tare ...20 D. Body Mass Index (BMI) ...20 E. Body Surface Area (BSA) ...21 F. Print ...21 V. Device Setup ...22

VI. Setup USB Connection to PC ...23 VII. Troubleshooting ...27

VIII. Product Specifications ...29

IX. Declaration of Conformity ...32

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I. Safety Notes

A. General Information Thank you for choosing this Charder Medical device. It is designed to be easy and straightforward to operate, but if you encounter any problems not addressed in this manual, please contact your local Charder service partner. Before beginning operation of the device, please read this user manual carefully, and keep it in a safe place for reference. It contains important instructions regarding installation, proper usage, and maintenance. Intended Use This device is intended to measure the weight of subjects who can stand unassisted, for diagnosis of weight-related issues by professionals.. General Handling  Device should be placed on stable, flat, solid, non-slippery surface.  Usage on soft surfaces (ex: carpet) may result in inaccurate results.  Ensure all parts are properly locked and tightened before operating the device.  Device is intended to measure one subject at a time. Safety Instructions  Batteries should be kept away from children. If swallowed, promptly seek medical assistance.  Expected service life: 5 years.  Always comply with appropriate regulations when using electrical components under increased safety requirements.  Ensure voltage marked on power supply matches mains power supply.  The device is intended for indoor use only.  Observe permissible ambient temperatures for use Environmental  All batteries contain toxic compounds; batteries should be disposed of via designated competent organizations. Batteries should not be incinerated. Cleaning  Device surface should be cleaned using alcohol-based wipes. Corrosive cleansing liquids should not be used. Pressure-washers should not be used. 5

 

Do not use large amounts of water when cleaning the device, as it may cause damage to the internal electronics. Always disconnect device from mains power before cleaning.

Maintenance  Device does not require routine maintenance. However, regular checking of accuracy is recommended; frequency to be determined by level of use and state of device. If results are inaccurate, please contact local distributor. Warranty/Liability  The period of warranty shall be eighteen (18) months, beginning on the date of purchase. Please retain your receipt as proof of purchase.  No responsibility shall be accepted for damage caused through any of the following reasons: unsuitable or improper storage or use, incorrect installation or commissioning by the owner or third parties, natural wear and tear, changes or modifications, incorrect or negligent handling, chemical, electrochemical, or electrical interference.  All maintenance, technical inspections, and repairs should be conducted by an authorized Charder service partner, using original Charder accessories and spare parts. Charder is not liable for any damages arising from improper maintenance or usage. Disposal  This product is not to be treated as regular household waste, but should be taken to a designated collection points for electronics. Further information should be provided by local waste disposal authorities. Warning  Only the original adapter should be used with the device. Using an adapter other than the one provided by Charder may cause malfunction.  Do not touch the power supply with wet hands.  Do not crimp the power cable, and avoid sharp edges.  Do not overload extension cables connected to the device.  Route cables carefully, to avoid tripping.  Keep device away from liquids.  Do not remove the plug by yanking on the cable.  Use only a correctly wired (100-240VAC) outlet, and do not use a multiple outlet extension cable. 6

 Do not under any circumstances dismantle or alter the device, as this could result in electric shock or injury as well as adversely affect the precision of measurements.  Do not place the device in direct sunlight, or in close proximity to an intense heat source. Excessively high temperatures may damage the internal electronics. Incident Reporting  Any serious incident that has occurred in relation to the device should be reported to the manufacturer, EU representative (if device is used in EU member state), and competent authority of user/subject's member state.

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B. EMC Guidance and Manufacturer's Declaration Guidance and manufacturer’s declaration-electromagnetic emissions

The MS4971 Stand-on Floor Scale is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emission test

RF emissions CISPR 11

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /flicker emissions IEC 61000-3-3

Compliance Group 1

Electromagnetic environment-guidance

The device 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.

Class B

The device 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.

Class A Compliance

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Guidance and manufacturer’s declaration-electromagnetic immunity The MS4971 Stand-on Floor Scale is intended for use in the electromagnetic environment specified below. The customer or the user of the device 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

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Electrical fast transient/burst IEC 61000-4-4

± 2kV for power supply lines + 1kV for input/output lines

+ 2kV for power supply lines + 1kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

± 1kV line(s) to line(s) ± 2kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

0% UT for 0,5 cycle 0% UT for 1 cycle

+ 1kV line(s) to line(s) + 2kV line(s) to earth 0% UT for 0,5 cycle 0% UT for 1 cycle

70% UT(30% dip in UT) for 25 cycles

70% UT(30% dip in UT) for 25 cycles

0% UT for 5 s

0% UT for 5 s

Surge IEC 61000-4-5

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency(50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

30 A/m

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. The device 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.

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Guidance and manufacturer’s declaration-electromagnetic immunity

The MS4971 Stand-on Floor Scale is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that is used in such an environment. Immunity test Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 test level 3 Vrms 150 KHz to 80 MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz 3 V/m 80MHz to 2,7 GHz

Compliance level 3 Vrms 150 KHz to 80 MHz

6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz 3 V/m 80MHz to 2,7 GHz

Electromagnetic environment-guidance

Portable and mobile RF communications equipment should be used no closer to any part of the device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1,2 √P d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 800MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

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NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distance between portable and mobile RF communications equipment and the MS4971 Stand-on Floor Scale

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of output power of transmitter m transmitter 150 kHz to 80 80 MHz to 800 800 MHz to 2,5 MHz MHz GHz W d =1,2√P d =1,2√P d =2,3√P 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

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For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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. NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 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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II. Installation

A. Assembly 1. Fasten and tighten four screws at the bottom of the base. Ensure four adjustable feet and stability foot are at same level before using device. Four screws

B. Inserting Batteries 1. Open battery housing cover

2. Take out battery housing

3. Place batteries in compartment (ensure polarity is correct)

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4. Insert battery housing

5. Close battery housing cover.

6. Turn on power to confirm that battery is correctly installed. C. Using Adapter 1. Connect adapter to indicator before connecting to mains power supply 2. Disconnect adapter from mains power supply before unplugging adapter pin from indicator.

AC Connector Port

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D. Attaching Height Rod to Column

1. Attach two fixing blocks to column using four flat-head screws

Item 1 2 3

2. Attach height rod to blocks using two flat-head screws

Name Fixing block screws Fixing blocks Height Rod to fixing block screws

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Quantity 4 2 2

Connecting height rod to indicator (HM200D/HM201D)

Secure excess cable to column

Digital height rod data transmission port on indicator

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E. Attaching Thermal Printer

Washer head screw M5*0.8*15mm Cross head screw M4*0.7*6mm

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III. Indicator A. Indicator and Key Functions

Key Function 1.

(UNIT): Switch between units. For OIML-approved version, only kg is activated.

2.

(Send Data): When printer is connected to the indicator, press this key to send results.

3.

(On/Off/Zero): Power button. Press and hold to turn off. Press once to zero weight.

4.

(HOLD/BMI): Press once to Hold (determine stable weighing value - used when weight is unstable). Press and hold for 3 seconds to enter Body Mass Index (BMI) calculation mode.

5.

(TARE/BSA): Press once to Tare (deduct weight from reading after measurement). After using BMI function, press once to display Body Surface Area (BSA). 17

B. Display layout

BSA: Body Surface Area is being displayed BMI: Body Mass Index is being displayed NET: Net weight appears after tare is activated HOLD: Weight lock function is in use

Stable Negative Zero

Battery Stable symbol: Indicates that weight is stable. Negative symbol: Weight under zero. Zero symbol: Weight is at zero Low battery: Battery needs to be charged or replaced.

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IV. Using Device Unit

Send

On/Off/Zero

Hold/BMI

Tare/BSA

A. Basic Operation Switch on the device using

key. (To turn off device, press and hold

key for 3 seconds) The device will automatically perform self-calibration, displaying software version. Once "0.00 kg" appears on indicator, device is ready for measurement. Note: If "0.00 kg" does not display on indicator, press the device.

key to zero

Guide subject to stand on device. After the weight has stabilized, the "stable" symbol will appear on indicator. Note: If subject's weight exceeds scale capacity (including tare), indicator will display "Err" prompt due to overload. B. Hold The hold function determines average weight, designed to be used if subject's weight will not stabilize (ex: an active child). Note: if fluctuation is too severe, average weight determination will be difficult and hold may not function correctly 1. Switch on the device normally.

2. Press the key. "HOLD" will be displayed on the indicator. 3. Guide subject to stand on device. 4. After a few seconds, the average weight will be displayed on the indicator. This weight will be locked - at this point, subject can leave measurement platform.

5. To release the locked weight, press the device to normal mode.

key again to return to the

Note: Hold function can be activated before or after subject stands on 19

device. However, if subject finds it difficult to stand still, we recommend activating Hold after subject stands on device. Hold function will not function under 2 kg. C. Tare The tare function allows the user to deduct the weight of objects from the device's measurement result. 1. Place object that needs to be tared onto measurement platform.

2. Press key after stable symbol appears on indicator. Display will indicate "0.00 kg". 3. Guide subject (plus tared object) to stand on device. Conduct measurement. 4. To clear tare value, remove all objects from measurement platform, and press

key.

D. Body Mass Index (BMI)

1. In normal mode, press and hold the key to enter BMI mode. 2. Display will show last input height. Left-most digit will flash. 3. Adjust height value using

(increase↑) and

(decrease↓)

keys. Proceed to next digit using key. Press key to confirm. 5. Proceed to weigh subject as usual. Indicator will display weight, height, and BMI after measurement. Height

BMI

weight

Risk of obesity-related disease Category BMI (kg/m2) Under < 18.5 Low Normal 18.5-24.9 Average Over 24.9-29.9 Slightly Increased Obese I 30.0-34.9 Increased Obese II 35.0-39.9 High Obese III > 40 Very High (World Health Organization adult BMI standards)

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