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Medical Scale User Manual and Compliance

This document provides a manufacturer's declaration of conformity for a medical device. It states that the product has been manufactured in accordance with harmonized European standards and the Medical Device Directive. The CE marking and information for the authorized EU representative and manufacturer are also included.

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0% found this document useful (0 votes)
104 views12 pages

Medical Scale User Manual and Compliance

This document provides a manufacturer's declaration of conformity for a medical device. It states that the product has been manufactured in accordance with harmonized European standards and the Medical Device Directive. The CE marking and information for the authorized EU representative and manufacturer are also included.

Uploaded by

D2Z0 CO
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Manufacturer’s Declaration of Conformity

This product has been manufactured in accordance with


the harmonized European standards, following the
provisions of the below stated directives:

93/42/EEC as amended by 2007/47/EC


Medical Device Directive

Please see separate document showing on sticker of device for


above CE marking.

Authorized EU Representative:

Manufactured by:
Charder Electronic Co., Ltd.
No.103, Guozhong Rd., Dali Dist.,
Taichung City, 412 Taiwan (R.O.C.)

FDA no.: D072479


MS 2400
Medical Scale
USER MANUAL

CD-IN-0987 [7010Q] 12/2018 Please keep the instruction manual at hand all the time for future reference.
23 0
 Software system crash
TABLE OF CONTENTS  Resonator faulty
PREFACE ................................................................................................. 2  Load cells with faulty grinding standard.
GENERAL INFORMATION .................................................................... 2  Key buttons failure - Front key panel damaged or disconnected
SAFETY INSTRUCTION ........................................................................ 2
ENVIRONMENTAL ................................................................................ 3 3. Buzzer malfunction
CLEANING .............................................................................................. 3  Wrong welding of PVC wire
MAINTENANCE ..................................................................................... 3  Key buttons & control panel damaged or disconnected.
WEIGHING OPERATION ....................................................................... 4
WARRANTY-LIABILITY ........................................................................ 4
DISPOSING OF THE SCALE .................................................................. 5
EXPLANATION OF THE GRAPHIC SYMBOLS.................................... 5
EMC GUIDANCE AND MANUFACTURER'S DECLARATION ............ 7
SPECIFICATIONS ................................................................................. 12
POWER ADAPTOR STANDARDS ....................................................... 13
KEY FUNCTIONS ................................................................................. 14
FEATURE DESCRIPTION..................................................................... 15
INSTRUCTION FOR REPLACING BATTERY ..................................... 16
ASSEMBLING BABY HEIGHT MEAS.-HM80D/80M ......................... 17
DIS-ASSEMBLING BABY HEIGHT MEAS. ........................................ 18
ERROR MESSAGE ................................................................................ 19
TROUBLESHOOTING .......................................................................... 20

I 22
force such as free-drop to the ground, collision by external objects,
PREFACE
etc.
 Proper re-calibration procedure required to correct the setting of Thank you for choosing CHARDER MEDICAL product. All features of this

weighing accuracy. product were designed to state of the art and are optimized for simple and

 Interference due to RF disturbance, ground vibration…etc. straightforward use. If you have any queries or experience any problems

 Unstable platform feet adjustments according to bubble level not addressed in the operating instructions, please contact your CHARDER

indication MEDICAL service partner, or visit us on the Internet at

 Incorrect position or other external objects within weighing area www.chardermedical.com

 The weighing-scale is not put in a solid & firm ground area, such as GENERAL INFORMATION
carpet floor or lawn. We strongly recommend you use the scales on flat and hard surface. Any
soft surface, like carpet will cause inaccuracy.
In case of the following defective mode occurs, it is suggested to contact SAFETY INSTRUCTION
your nearest Authorized Dealer for further technician service & repair:
Before putting the device into use, please read with care the
1. POWER switch-on failure : information given in the Operating Instructions. They contain important
 Push-button faulty
instructions for installation, proper use and maintenance of the device.
 Short circuit wires - Wire broken
 Safety fuse burnt out
The manufacturer shall not be liable for damages arising out of
 Wire connection problem failure to heed the following instructions:
 Main power adaptor faulty – Parts Replacement
2. LCD display faulty When using electrical components under increased safety requirements,
 Possible hardware defects include: Uneven brightness in the LCD always comply with the appropriate regulations.
display screen & texts color blurred, smeared rainbow screen, Improper installation will render the warranty null and void.
incorrect decimal display Ensure the voltage marked on the power supply unit matches your mains
 LCD PIN broken or short circuit power supply.
 PCB cooper foil broken & loosed welding This device is designed for use indoors.
 Unable to save or read data – IC or transistor faulty, internal parts Observe the permissible ambient temperatures for use
broken. The device meets the requirements for electromagnetic compatibility. Do not
 LCD showing “ERRL” after switch on - Load cell damaged exceed the maximum values specified in the applicable standards.
 Overload may cause the weigh to malfunction.
21 2
These batteries should be kept away from small children. If swallowed, TROUBLESHOOTING
Troubleshooting for defective modes:
promptly seek medical assistance.
If you have any problem, contact your local CHARDER MEDICAL service
Original purchaser can enjoy the benefits under the effective Warranty
partner. against functional defects in material and workmanship subject to the
terms and conditions listed in the yearly Warranty Program & Return
Expected Service Life: 5 years

ENVIRONMENTAL Policy.
All batteries contain toxic compounds; disposal of batteries should be
Our warranty service program includes the following:
delegated to a competent organisation, complying with the deposit of
1. Technician repair service under warranty or at a service
Poisonous Waste Regulation 1972.
maintenance charge depending on the workmanship for the
Please do not incinerate batteries.
defective functionality or cause of damage covered by the
The optimum operating temperature for the scale is 5℃ to +35℃; although it warranty.
will operate at higher and lower temperatures the scales battery life will be
2. Parts replacement from the manufacturing factory under the
adversely effected.
warranty or at a certain cost for the replaced parts plus the
workmanship charge if not covered under the warranty.
Before you contact our Authorized Dealer in your country for technician
CLEANING repair service, please read through the following section carefully:
We would recommend using alcohol based wipes or similar when cleaning the

Self-checking Tips:
scales.
Please do not use large amounts of water when cleaning the scales as this will
cause damage to the scales electronics, you should also refrain from using Some functional defects can be identified and maintained by
corrosive liquids or high pressure washers. users as listed below:
Always disconnect the scales from the mains power supply before cleaning.
1. Power-on failure
 Check if the main power adaptor has not plugged onto the scale
MAINTENANCE
properly
The scale does not require any routine maintenance. However, we recommend  Check if the battery power is running low - Replace with new
checking the scale’s accuracy at regular intervals. The regularity of these batteries
checks is dependent on the level of use and the state of the scale. If any 2. Indicator showing “0000” ZERO SPAN out of range
inaccuracies occur, please contact your local  Incorrect weighing result - Avoid damages by external environment

3 20
ERROR MESSAGE WEIGHING OPERATION
Before reading detailed instructions on how to use all the weighing functions
that are built into your scale, please read the following important guidelines:
 LOW BATTERY Always be sure that the display shows `Zero` before use, if it does not then
If battery is discharged, the display will please press the ZERO key.
show LOW. The operator should replace The Professional Medical scale is designed to detect when a stable weight is
the battery. achieved, the indicator will `bleep` twice to indicate a stable weight value, your
reading should be taken at this point.
 OVER ZERO
If zero count is higher than the setting
WARRANTY-LIABILITY
range, the display will show “Err” message.
If a fault or defect is present on receipt of the unit which is within CHARDER
The scale will turn off in 30 seconds if the
MEDICAL’s scope of responsibility, CHARDER shall have the right to either
status continues.
repair the fault or supply a replacement unit. Replaced parts shall be the

 UNDER ZERO property of CHARDER. Should the fault repairs or replacement delivery not be

If zero count is below the setting range, the successful, the statutory provisions shall be valid. The period of warranty shall

display will show “Errl” message. The be two years, beginning on the date of purchase. Please retain your receipt as

scale will turn off in 30 seconds if the status proof of purchase. Should your scale require servicing, please contact your

continues. dealer or CHARDER MEDICAL Customer Service.


No responsibility shall be accepted for damage caused through any of the
following reasons: Unsuitable or improper storage or use, incorrect installation
 OVERLOAD or commissioning by the owner or third parties, natural wear, changes or
If the total load exceeds the maximum modifications, incorrect or negligent handling , overuse, chemical,
capacity of the scale, the display will show electrochemical or electrical interference or humidity, unless this is attributable
“Err” message. The weight must be to negligence on the part of CHARDER MEDICAL.
removed immediately from the surface. If operating, climatic or any other influences lead to a major change in
conditions or material quality, the treaty for perfect unit functioning shall be
rendered null and void. If CHARDER provides and individual warranty, this
means that the unit supplied will be free of faults for the length of the warranty
period.
19 4
DISPOSING OF THE SCALE Place the baby height meas. (HM-80M or HM-80D). properly on the
This product is not to be treated as regular household waste, but should be
bracket and click it.
handed in to an electrical/electronic equipment recycling centre.
You can obtain further details from your local council, your municipal waste
disposal company or the firm which you purchased the product.

EXPLANATION OF THE GRAPHIC SYMBOLS

SN-T13000001 Designation of the serial number of


every device, applied at the device.

(Number as an example)
“Please note the accompanying
documents“
DIS-ASSEMBLING BABY HEIGHT MEAS.
or “Observe operating instructions”
Find the buckle at the back of baby height measurement.
Depressing buckle and remove the height measurement gently from
Identification of manufacturer of
the bracket.
medical product including address

Charder Electronic Co., Ltd.


No.103, Guozhong Rd., Dali Dist.,

Taichung City 412, Taiwan (R.O.C.)

Type B applied parts.

5 18
Dispose of old appliances
ASSEMBLING BABY HEIGHT MEAS.-HM80D/80M
separately from your household
1. Place the bracket and tighten the screw with screw driver.
waste!!
Instead, take them to communal
collection points.
Carefully read this operation manual
rubber head pad before setup and commissioning,
even if you are already familiar with
Charder scales.

Fix the bracket here for the scale


with rubber head pad
rubber head pad

Fix the bracket here for the scale


without rubber head pad

17 6
EMC GUIDANCE AND MANUFACTURER'S DECLARATION INSTRUCTION FOR REPLACING BATTERY

STEP 1. STEP 2.
Guidance and manufacturer’s declaration-electromagnetic emissions
The digital weighing SCALE MS 2400 is intended for use in the
electromagnetic environment specified below.
The customer or the user of the digital weighing scale MS 2400 should
assure that it is used in such an environment.
Electromagnetic
Emission test Compliance
environment-guidance
RF emissions Group 1 The digital weighing scale MS
2400 uses RF energy only for
CISPR 11 its internal function. Therefore, LOCATE THE BATTERY
its RF emissions are very low COVER
and are not likely to cause any
interference in nearby
electronic equipment.
STEP 3. STEP 4.
RF emissions Class B The digital weighing scale MS
2400 is suitable for use in all
CISPR 11 establishments, including
Harmonic emissions Class A domestic establishments and
those directly connected to the
IEC 61000-3-2 public low-voltage power
supply network that supplies
Voltage fluctuations Compliance
buildings used for domestic
/flicker emissions purposes.
IEC 61000-3-3

STEP 5.

7 16
FEATURE DESCRIPTION Guidance and manufacturer’s declaration-electromagnetic immunity
The digital weighing scale MS 2400 is intended for use in the electromagnetic
MEMORY environment specified below.
The customer or the user of the digital weighing scale MS 2400 should assure that
When power on, the Memory feature will auto switch on and the arrow besides it is used in such an environment.
HOLD at left bottom of LCD will flicker.
IEC 60601 test Compliance Electromagnetic
Immunity test
When the loaded weight is above 1kg and stable, the arrow stops flickering. level level environment-guidance
To disable the Memory function, please press ON/ZERO/OFF key again. Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood,
concrete or ceramic tile.
discharge(ESD) ± 8 kV air ± 8 kV air If floors are covered with
IEC 61000-4-2 synthetic material, the
TARE relative humidity should
be at least 30%
TARE only works under 400g. When weight of subject is under 400g, press ± 2kV for power ± 2kV for power Mains power quality
Electrical fast
[ON/ZERO/OFF] key to tare the weight. When the arrow of hold flickered, the supply lines + supply lines Not should be that of a typical
transient/burst 1kV for applicable commercial or hospital
TARE feature is working now. Put your tare object on the scale and start input/output environment.
IEC 61000-4-4
weighing, then remove the tare object again. Wait for the display to return lines
Surge IEC ± 1kV line(s) to ± 1kV differential Mains power quality
zero, and put the baby to be weighed together with the tare object. line(s) ± 2kV mode Not should be that of a typical
61000-4-5 line(s) to earth applicable commercial or hospital
environment.
Voltage Dips, <5% UT(>95% <5% UT(>95% Mains power quality
short dip in UT) for 0,5 dip in UT) for 0,5 should be that of a typical
interruptions cycle 40% cycle 40% commercial or hospital
and voltage UT(60% dip in UT(60% dip in environment. If the user
variations on UT) for 5 cycles UT) for 5 cycles of the digital weighing
power supply 70% UT(30% 70% UT(30% scale requires continued
input lines IEC dip in UT) for 25 dip in UT) for 25 operation during power
61000-4-11 cycles <5% cycles <5% mains interruptions, it is
UT(>95% dip in UT(>95% dip in recommended that the
UT) for 5 s UT) for 5 s digital weighing scale be
powered from an
uninterruptible power
supply or a battery.

15 8
Power 3 A/m 3 A/m The digital weighing KEY FUNCTIONS
frequency(50/60 scale power frequency
Hz) magnetic magnetic fields should be
field IEC at levels characteristic of
61000-4-8 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.
MEMORY kg/lb ON
ZERO
OFF

Guidance and manufacturer’s declaration-electromagnetic immunity


The digital weighing scale MS 2400 is intended for use in the electromagnetic
environment specified below.
The customer or the user of the digital weighing scale MS 2400 should assure that Key Functions
is used in such and environment.
IEC 60601 test Compliance Electromagnetic
Immunity test ON/ZERO/OFF
level level environment-guidance
Conducted RF 3 Vrms 3 Vrms
Portable and mobile RF  Power on and power off.

communications equipment
IEC 61000-4-6 150 KHz to 80 MHz should be used no closer to any Press to ZERO the weight of subject.
part of the digital weighing  Press 3 seconds to power off.
scale MS 2400 including
cables, than the recommended  Press to TARE the weight when the weight is at 2% of full capacity.
separation distance calculated
from the equation applicable to
the frequency of the transmitter. kg/lb
 Press this key to switch unit between kg, lb, oz, and lb: oz.
Recommended separation
distance:
d = 1,2 √P MEMORY
d = 1,2 √P

80MHz to 800 MHz
d = 2,3 √P 800MHz to 2,5 GHz Press to recall and release the weighing value.
 If the weight is less than 1kg, press this key to recall the stored value
Where P is the maximum output
power rating of the transmitter in of weight. If the weight is greater than 1kg, press this key to store the
watts (W) according to the weight value
transmitter manufacturer and d is
the recommended separation
distance in metres (m).

9 14
POWER ADAPTOR STANDARDS
Field strengths from fixed RF
transmitters, as determined by an
a
electromagnetic site survey ,
should be less than the
compliance level in each
b
frequency range .

Interference may occur in the


vicinity of equipment marked with
the following symbol:

Radiated RF 3 V/m 80MHz to 2,5 3 V/m


IEC 61000-4-3 GHz
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 digital weighing scale is
used exceeds the applicable RF compliance level above, the digital weighing
scale should be observed to verify normal operation. If abnormal performance
is observed, additional measures my be necessary, such as re-orienting or
relocating the digital weighing scale.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be les than
3 V/m.

13 10
Recommended separation distance between
SPECIFICATIONS
portable and mobile RF communications equipment and the digital weighing
scale MS 2400 Model# MS 2400
The digital weighing scale MS 2400 is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or Capacity 20 kg x 10 g, 44 lb x 0.02 lb, 704 oz x 0.5 oz
the user of the digital weighing scale MS 2400 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile Accuracy ±20g , ±0.04lb , ±1.0oz
RF communications equipment (transmitters) and the digital weighing scale as
Weight units kg, lb, oz, lb:oz
recommended below, according to the maximum output power of the
communications equipment.

Operating Temp. & +5°C - +35°C


Rated maximum output Separation distance according to frequency of transmitter m

Humidity 15% - 85% RH


power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

LCD Display Easy to read 1.0” LCD display with 4 1/2 digits
d =1,2√P d =1,2√P d =2,3√P
W

0,01 0,12 0,12 0,23 Scale with handle:


0,1 0,38 0,38 0,73 24 x 14 x 2 in. (620 x 350 x 50 mm)
Dimension
1 1,2 1,2 2,3 Platform surface:
10 3,8 3,8 7,3 20 x 14 x 2 in. (500 x 350 x 50 mm)

Key Function ON/ZERO/OFF, kg / lb, MEMORY


100 12 12 23
For transmitters rated at a maximum output power not listed above, the

Power Supply 9V battery / 12V 500mA


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.

11 12

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