KERN MCN 200K-1M User manual

KERN & Sohn GmbH
Ziegelei 1
72336 Balingen-Frommern
Germany
+0049-[0]7433-9933-0
+0049-[0]7433-9933-149
[email protected]
Operating instructions
Medical Chair scales
KERN MCN
TMCN 200K-1M-A
Version 1.3
2022-06
GB
TMCN_A-BA-e-2213

2 TMCN_A-BA-e-2213
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TMCN_A-BA-e-2213 3
GB
KERN TMCN
Version 1.3 2022-06
Operating manual chair scales
Contents
1Technical data................................................................................................ 5
2Declaration of conformity ............................................................................. 6
2.1 Explanation of the graphic symbols for medical products........................................... 6
3Appliance overview ....................................................................................... 9
3.1 Overview of displays.................................................................................................11
3.2 Keyboard overview...................................................................................................12
3.3 Dimensions...............................................................................................................13
4Basic Information (General)........................................................................ 14
4.1 Specific function........................................................................................................14
4.1.1 Indication .................................................................................................................................. 14
4.1.2 Contraindication........................................................................................................................ 14
4.2 Proper use................................................................................................................14
4.3 Non-intended product use / contraindications ...........................................................16
4.4 Warranty...................................................................................................................16
4.5 Monitoring of Test Resources...................................................................................16
4.6 Plausibility check ......................................................................................................17
4.7 Reporting serious incidents.......................................................................................17
5Basic Safety Precautions............................................................................ 18
5.1 Pay attention to the instructions in the Operation Manual .........................................18
5.2 Personnel training.....................................................................................................18
5.3 Preventing contamination .........................................................................................18
5.4 Preparation for use...................................................................................................18
6Electromagnetic compatibility (EMC)......................................................... 19
6.1 General hints............................................................................................................19
6.2 Electromagnetic emission of interferences................................................................20
6.3 Electromagnetic immunity to interferences................................................................21
6.3.1 Crucial features of performance............................................................................................... 23
6.4 Minimum distances...................................................................................................23
7Transport and storage................................................................................. 24
7.1 Testing upon acceptance..........................................................................................24
7.2 Packaging / return transport......................................................................................24
8Unpacking, Installation and Commissioning............................................. 25
8.1 Installation Site, Location of Use...............................................................................25
8.2 Unpacking.................................................................................................................25
8.3 Scope of delivery......................................................................................................25
8.4 Installing the chair scales..........................................................................................26
8.4.1 Levelling ................................................................................................................................... 26
8.5 Battery operation ......................................................................................................28
8.6 Rechargeable battery operation using an optional battery power pack .....................30
8.7 Mains connection......................................................................................................30
8.7.1 Safety cable.............................................................................................................................. 31
8.8 Initial Commissioning................................................................................................31

4 TMCN_A-BA-e-2213
9Operation...................................................................................................... 32
9.1 Weighing...................................................................................................................32
9.2 Taring.......................................................................................................................33
9.2.1 Subsequent tare weight............................................................................................................ 33
9.2.2 Pretare...................................................................................................................................... 33
9.3 HOLD function..........................................................................................................36
9.4 Calculation of the Body Mass Index..........................................................................37
9.4.1 Classification of BMI values ..................................................................................................... 38
9.5 Automatic switch-off function „AUTO OFF“ ...............................................................38
9.6 Signal tone when pressing button.............................................................................40
9.7 Setting time and date................................................................................................41
10 Menu ............................................................................................................. 42
10.1 Navigation in the menu.............................................................................................42
10.2 Menu overview..........................................................................................................43
11 Communication with peripheral devices via KUP connection................. 45
11.1 KERN Communications Protocol (KERN Interface Protocol).....................................45
11.2 Data output after pressing the PRINT button < manual >..........................................46
11.3 Automatic data output < auto>..................................................................................47
11.4 Continuous data output < cont >...............................................................................47
11.5 Data format...............................................................................................................48
11.6 WLAN.......................................................................................................................48
11.7 Print function.............................................................................................................50
12 Bluetooth...................................................................................................... 51
13 Alibi memory (optional)............................................................................... 51
14 Error messages............................................................................................ 52
15 Servicing, maintenance, disposal .............................................................. 53
15.1 Cleaning ...................................................................................................................53
15.2 Cleaning / disinfecting...............................................................................................53
15.3 Sterilisation...............................................................................................................53
15.4 Servicing, maintenance.............................................................................................53
15.5 Disposal....................................................................................................................53
16 Instant help for troubleshooting................................................................. 54
17 Verification ................................................................................................... 55
17.1 Verification validity period (current status in D) .........................................................56
18 Adjustment................................................................................................... 57
18.1 Adjustment switch and seal marks............................................................................59

TMCN_A-BA-e-2213 5
1 Technical data
KERN
MCN 200K-1M
Item no./ Type
TMCN 200K-1M-A
Display
6-digit
Readability (d)
0.1 kg
Weighing range (max)
250 kg
Minimum load (min)
2 kg
Verification value (e)
100 g
Accuracy for first verification
≤50 kg = 0.5 e
>50 kg-200 kg = 1 e
>200 kg –250 kg = 1.5 e
Linearity
± 0.1 kg
Display
LCD with 25mm high digits
Recommended adjustment weight, not
added (Category)
200 kg
(M1)
Warm-up time
10 min
Operating temperature
10° C …. + 40° C
Storage and transportation
environment
-20 to +60°C, and 30% to 90% relative humidity
Humidity of air
max. 80 % (not condensing)
Atmospheric pressure (kPa)
70kpa-106kpa
Input Voltage
6 V / 1 A
Battery use
6 x 1.5 V AA
Battery working range:
48 hours background illumination off
24 hours background illumination on
Loading time: 8 hours
Auto Off
after 3, 5, 15, 30 min without load change (adjustable)
Dimensions fully mounted
(W x D x H) mm
625 x 990 x 985
Dimensions Weighing surface
(W x D) mm
390 x 360
Weight kg (net)
23,3
Rechargeable battery operation
optional; 3.8 VDC –4.2 VDC / 3700 mAh
Medical product in accordance with
93/42/EEC
Category I with measuring function
Verification in accordance with
2014/31/EU
Category III
Data interface
Intern: Wi-Fi
Optional / Extern:
KUP (RS232, Bluetooth, USB-D, Extension box)

6 TMCN_A-BA-e-2213
2 Declaration of conformity
The current EC/EU Conformity declaration can be found online in:
www.kern-sohn.com/ce
For verified weighing scales (= weighing scales assessed for
conformity) the declaration of conformity is included in the scope of
delivery.
Only these balances are medical products.
2.1 Explanation of the graphic symbols for medical products
All medical balances with this mark fulfill the
following guidelines:
1. 2014/31/EU: Guideline for non-automatic
balances
2. 93/42/EEC: Guideline for medical products
Balances which carry this mark, are conformity-
evaluated as per accuracy class III of the EC-
guideline 2014/31/EU. Accuracy of the balance see
chapter 1 Technical data.
WF 1734331
Designation of the serial number of every device,
applied at the device and on the packaging
Number here as example
2022-06
Identification of the manufacturing date of the
medical product.
Year and month here as example
“Attention, please note the accompanying
document“,
or “Please note operating instructions”

TMCN_A-BA-e-2213 7
“Observe operating instructions”
“Observe operating instructions”
Kern & Sohn GmbH
D–72336 Balingen,Germany
www.kern-sohn.com
Identification of manufacturer of medical product
including address
“Electro-medical device“
with attachment for type B
Device protection class II
Dispose of old appliances separately from your
household waste!
Instead, take them to communal collection points.
6 V / 1 A
Display of supply voltage for scales with polarity
display

8 TMCN_A-BA-e-2213
The chair scales may not be used for the transport of
people and objects!
Do not step onto the foot rests when stepping or
leaving the chair scales!
After the balance having been transported to the
patient, the balance must be levelled prior to weighing.
Mains connection
Sealing mark KERN SEAL
Supply voltage direct current
Information
Level balance before use
Electrostatically endangered structural
components

TMCN_A-BA-e-2213 9
3 Appliance overview
1. Seat pan
2. Bubble level
3. Display Unit
4. Manipulations
5 Rechargeable battery compartment 6 Mains connection 7 KUP

10 TMCN_A-BA-e-2213
Parking brake and adjustment foot
Parking brake opened
Parking brake closed
Foot rest and adjustment foot
Folding arm rests

TMCN_A-BA-e-2213 11
3.1 Overview of displays
Stability display
Scales are in a steady state
Zeroing display
Should the balance not display exactly
zero despite empty weighing plate, press
the button. Your balance will be
set to zero after a short standby time.
NET
Net weight display
Illuminated when net weight is displayed
Illuminated after weighing scale was
tared
GROSS
Gross weight display
Illuminated when gross weight is
displayed
HOLD
HOLD function
HOLD function active
BMI
BMI function
Illuminated while BMI function is enabled
Battery symbol
Shows the charging capacity of the
batteries
kg
Weighing unit
Displays the weighing unit
WiFi-interface
Shows the connection to the cableless
network

12 TMCN_A-BA-e-2213
3.2 Keyboard overview
Button
Designation
Function
ON/OFF-button
Turn on/off
HOLD button
Hold function/Calculation of a stable weight value
In menu:
•Select menu items
For numeric entry:
•Lowering numeric value
BMI button
Calculation of the Body Mass Index
In menu:
•Return to weighing mode
Print button
Data transfer via interface
In menu:
•Select menu items
For numeric entry:
•Increase numerical value
Function key
Function quick key
Quick call-up of a function stored before
Zeroing key
Weighing scale will be reset to „0.0“
In menu:
•Confirm selection
For numeric entry:
•Change decimal digit
•Confirm entry
TARE key
Tare balance

TMCN_A-BA-e-2213 13
3.3 Dimensions

14 TMCN_A-BA-e-2213
4 Basic Information (General)
Balances have to be verified for the purposes stated below in
accordance with Directive 2014/31/EU. Article 1, paragraph 4.
“Determination of mass in the practice of medicine that is, weighing
patients for reasons of medical supervision during medical
surveillance, examination and treatment.”
4.1 Specific function
4.1.1 Indication
•Determining the body weight in the medical practice area.
•Using as „non-automatic balance“
➢Place the person carefully in the middle of the seat surface.
Once a steady display value is shown, you can read the weight result.
4.1.2 Contraindication
No contraindication known.
4.2 Proper use
These scales are used to determine weight of people sitting at rest in medical treatment
rooms. The scales are suitable for recognizing, preventing and controlling illnesses.
•The person to be weighed should carefully sit down on the center of the seat of
the chair scales and remain seated quietly.
Once a steady display value is shown, you can read the weight result. The weighing
scale is designed for continuous duty.
The balances shall only be used by people who can sit still.
•The foot rests of the chair scales are fitted with an anti-slip surface that must
not be covered during weighing a person.
•The balances should be checked for correct condition prior to each utilization
by a person familiar with proper operation of the balance.

TMCN_A-BA-e-2213 15
▪The chair scales may not be used for the transport of people and objects!
▪As long as the patient is sitting on the chair scales, the wheel brakes must be
locked without fail
▪The arm rests of the chair scales may only be used to rest the lower arms, not for
bracing
▪When leaving the balance, fold up the arm rests and have the patient braced by a
trained person
▪Install the chair scales always on a level, even surface
▪Do not step onto the foot rests when stepping or leaving the chair scales!
The WIFI interface allows a wireless transfer of the measurement results to a PC.
Scales fitted with a serial interface may only be connected to
appliances in compliance with Directive
EN60601-1.
If the balance doesn’t have any contact with the transfer cable,
do not touch the transfer port in order to avoid an ESD-failure.

16 TMCN_A-BA-e-2213
4.3 Non-intended product use / contraindications
•Do not use these scales for dynamic weighing processes.
•Do not leave permanent load on the weighing pan. This
may damage the measuring system.
•Impacts and overloading exceeding the stated maximum
load (max) of the weighing plate, minus a possibly existing
tare load, must be strictly avoided. This could cause
damage to the balance.
•Never operate the balance in explosive environment. The
serial version is not explosion protected. It should be noted
that a flammable mixture of anaesthetics and oxygen or
laughing gas may occur.
•The structure of the balance may not be modified. This may
lead to incorrect weighing results, safety-related faults and
destruction of the balance.
•The balance may only be used according to the described
conditions. Other areas of use must be released by KERN
in writing.
•If the balance is not used for a longer time, take out the
batteries and store them separately. Leaking battery liquid
could damage the balance.
•The balance may only be used for weighing persons.
Persons who are heavier than the indicated maximum load,
may not step onto the balance.
4.4 Warranty
Warranty claims shall be voided in case:
▪Our conditions in the operation manual are ignored
▪The appliance is used beyond the described uses
▪Modification or opening of appliances
▪Mechanical damage and damage caused by media, liquids,
▪Natural wear and tear
▪The appliance is improperly set up or incorrectly electrically connected
▪The measuring system is overloaded
▪Dropping of scales
4.5 Monitoring of Test Resources
In the framework of quality assurance the measuring-related weighing properties of the
balances and, if applicable, the testing weight, must be checked regularly. The
responsible user must define a suitable interval as well as type and scope of this test.
Information is available on KERN’s home page (www.kern-sohn.com) with regard to

TMCN_A-BA-e-2213 17
the monitoring of balance test equipment and the test weights required for this. In
KERN’s accredited DKD calibration laboratory test weights and balances may be
calibrated (return to the national standard) fast and at moderate cost.
4.6 Plausibility check
Please make sure that the measurement values computed by the appliance are
plausible and are allocated to the respective patient, before storing and using the
values for further purposes. This applies especially also for values transferred via
interface.
4.7 Reporting serious incidents
All serious incidents appeared related to this product must be reported to the
manufacturer and the responsible authority of the member state where the user and/or
the patient are residents.
„Serious incident“ that means an incident which directly or indirectly had, could have
or could have had one of the following consequences:
➢the death of a patient, a user or another person,
➢the temporary or permanent fatal deterioration of the health status of a patient,
a user or other persons,
➢a serious danger for public health.

18 TMCN_A-BA-e-2213
5 Basic Safety Precautions
5.1 Pay attention to the instructions in the Operation Manual
Carefully read this operation manual before
setup and commissioning, even if you are
already familiar with KERN balances.
5.2 Personnel training
The medical staff must apply and follow the operating instructions for proper use and
care of the product.
The balance must be set up via the interfaces and integrated into a network only by
experienced administrators or hospital technicians.
5.3 Preventing contamination
The prevention of cross-contamination (fungal skin infections,……) requires regular
cleaning of the seating surface.
Recommendation: After any weighing procedure that could potentially result in
contamination (e. g. after weighing that involves direct skin contact).
5.4 Preparation for use
•Check the balance for damage before any use
•Maintenance and reverification: The balance must be serviced and reverified at
regular intervals.
•Do not use the appliance on slippery surfaces or in facilities with risk of vibration
•During installation the balance must be levelled.
•If possible, the product must remain in its original packaging for transportation
purpose. Should this not be possible, make sure that the product is protected
against damage
•Step onto and leave the personal balance only when a qualified person is
present

TMCN_A-BA-e-2213 19
6 Electromagnetic compatibility (EMC)
6.1 General hints
This device complies with the limits set for medical electrical devices of group 1, class
B (as per EN 60601-1-2). The appliance is suitable for home care, as well as for
commercial clinic environment.
Electromagnetic compatibility (EMC) describes a device’s ability to perform reliably
within an electromagnetic environment without causing inadmissible electromagnetic
interference at the same time. Amongst other things, such disturbances may be
transmitted by connecting cables or by the air.
Inadmissible interferences from the environment may result in wrong displays,
inaccurate measured values or incorrect behavior of the medical device.
By the same token the medical device may in some cases cause such disturbances in
other devices. To eliminate problems of that kind, we recommend you to take one or
several of the measures listed below:
•Change the alignment or distance of the device to the source of EMI.
•Install or use the balance on another place.
•Connect the balance to another power source.
•For further questions please contact our customer services.
The installation and use of this electrical medical device requires
special precautionary measures as outlined in the EMC information
below.
Do not install the appliance near active surgical high-frequency devices
and radio-frequency-shielded rooms of a ME system for magnetic
resonance production, where high intensity of electromagnetic
interferences occurs.
Do not operate the appliance near or stacked on other appliances as
could have as consequence inaccurate measuring results. If such use
should be necessary, this appliance and other devices should be
observed in order to ensure that they work normally.
The use of accessories, transformers and other cables than the ones
specified by the dealer and delivered by him with the device could have
as consequence amplified electromagnetic radiation or a weakened
resistance against electromagnetic interferences and by that way less
functionability.
Portable radiofrequency communication device (incl. periphery,
antenna cable and external antennae) should be placed at a distance
of at least 30 cm (12 inch) from each part of MWN including the cables
admitted by the manufacturer. Otherwise the performance of the
appliance could drop down.

20 TMCN_A-BA-e-2213
Disturbances may be caused by improper modification or add-ons to the device or not
recommended accessories (such as power supply units or connecting cables). The
manufacturer will not be responsible for these. Modifications may also result in a loss
of authorization relating to the use of the device.
Devices emitting high frequency signals (mobile telephones, radio
transmitters, radio receivers) may cause interference in the balance.
For that reason do not use them near the balance. Chapter 6.4
contains details about recommended minimum distances.
6.2 Electromagnetic emission of interferences
Guidelines and manufacturer’s declaration – electromagnetic interferences
The balance is determined for the use in an electromagnetic environment, which
complies with the requirements specified below. The customer or user of the medical
electrical device must ensure that operation takes place in such an environment.
Irradiation test
Conformity
Radio irradiation
CISPR 11
Assembly 1
Radio irradiation
CISPR 11
Class B
Harmonic irradiations
IEC 61000-3-2
Category A
Voltage fluctuations/ Flicker
irradiation
IEC 61000-3-3
Compliance