KERN MBA User manual

KERN & Sohn GmbH
Ziegelei 1
D-72336 Balingen
E-Mail: [e-mail]
Phone: +49-[0]7433- 9933-0
Fax: +49-[0]7433-9933-149
Internet: www.kern-sohn.com
Operating manual
Baby scale
KERN MBA
Type TMBA-B
Version 1.8
2021-02
GB
TMBA_B-BA-d-2118

2 TMBA_B-BA-e-2118
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TMBA_B-BA-e-2118 3
GB
KERN MBA
Version 1.82021-02
Operating manual
Baby scale
Contents
1Technical data................................................................................................ 5
2Declaration of conformity ............................................................................. 6
2.1 Explanation of the graphic symbols for medical products.................................................. 6
3Appliance overview ....................................................................................... 9
3.1 Dimensions ............................................................................................................................. 10
3.2 Overview of display................................................................................................................ 10
3.3 Keyboard overview................................................................................................................. 12
4Basic Information (General)........................................................................ 13
4.1 Specific function..................................................................................................................... 13
4.2 Intended use ........................................................................................................................... 13
4.3 Improper Use / Contraindications......................................................................................... 14
4.4 Warranty.................................................................................................................................. 14
4.5 Monitoring of Test Resources............................................................................................... 15
5Basic Safety Precautions............................................................................ 16
5.1 Pay attention to the instructions in the Operation Manual................................................ 16
5.2 Personnel training.................................................................................................................. 16
5.3 Preventing contamination ..................................................................................................... 16
5.4 Preparing for use.................................................................................................................... 16
6Electromagnetic compatibility (EMC)......................................................... 17
6.1 General hints........................................................................................................................... 17
6.2 Electromagnetic interferences.............................................................................................. 19
6.2.1 Degradation of performance..................................................................................................... 19
6.3 Electromagnetic noise immunity.......................................................................................... 20
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, Setup and Commissioning ..................................................... 25
8.1 Installation Site, Location of Use.......................................................................................... 25
8.2 Unpacking ............................................................................................................................... 25
8.3 Scope of delivery.................................................................................................................... 25
8.4 Installation............................................................................................................................... 26
8.5 Battery operation.................................................................................................................... 26
8.6 Mains connection (option)..................................................................................................... 29
8.7 Optional equipment mains adapters.................................................................................... 29
8.8 Initial Commissioning ............................................................................................................ 29

4 TMBA_B-BA-e-2118
9Operation...................................................................................................... 29
9.1 Weighing ................................................................................................................................. 29
9.2 Taring....................................................................................................................................... 30
9.3 Hold function (Standstill function) ....................................................................................... 31
9.4 Auto off (Automatic switch-off function) ............................................................................. 32
9.5 Using the optional equipment height measuring rod MBA-A01........................................ 33
10 Menu ............................................................................................................. 34
10.1 Navigation in the menu.......................................................................................................... 34
10.2 Menu overview........................................................................................................................ 35
11 Error reports................................................................................................. 36
12 Servicing, maintenance, disposal .............................................................. 37
12.1 Cleaning .................................................................................................................................. 37
12.2 Cleaning / disinfecting........................................................................................................... 37
12.3 Sterilisation............................................................................................................................. 37
12.4 Servicing, maintenance ......................................................................................................... 37
12.5 Disposal................................................................................................................................... 37
13 Instant help................................................................................................... 38
14 Verification................................................................................................... 39
14.1 Verification validity period (current status in D)................................................................. 40
15 Adjustment................................................................................................... 41
16 Equipment (optional)................................................................................... 43

TMBA_B-BA-e-2118 5
1 Technical data
KERN MBA 10K-3M
Item no./ Type TMBA 15K-3M-B
Weighing range (max)
15 kg
Minimum load (Min)
0.1 kg
Readability (d)
0.005 kg
Verification value (e)
0.005 kg
Reproducibility
0.005 kg
Linearity
0.005 kg
Display
LCD with 25mm high digits
Recommended adjustment
weight, not added (class) 15 kg
(M1)
Stabilization time (typical)
3 sec.
Warm-up time
10 min
Operating temperature
10° C …. + 40° C
Storage and Transport
Environment
-10 to +60°C, and 30% to 90% relative humidity
Atmospheric pressure: 700-1060 hPa
Humidity of air
max. 80 % (not condensing)
Atmospheric pressure (kPa)
70kpa-106kpa
Input Voltage
100 V - 240 V, 50 / 60 Hz
Output Voltage
power supply
DC 12V/500mA
Battery use
6 x 1,5 V AA
battery working period:
50 hours
Auto Off
can be adjusted after "30, 60, 180" sec. or "Off" without load
change
Dimensions fully mounted
(W x D x H) mm 890 x 470 x 175
Baby weighing pan
(B x D x H) mm
600 x 260
Weight kg (net)
4.6
Verification in accordance
with 2014/31/EU Class III
Medical product in
accordance with 93/42/EEC Category Im (with measuring function)
Height measuring rod,
optional MBA-A01, Measuring range 40 – 80 cm

6 TMBA_B-BA-e-2118
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) a
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/EC: Guideline for medical products
Balances which carry this mark, are conformity-
evaluated as per accuracy class III of the EC-guideline
2014/31/EU.
WF 202795
Designation of the serial number of every device, applied at the device and on the packaging
(Number as an example)
2021-02
Identification of the manufacturing date of the medical
product.
(Year and month here as example)

TMBA_B-BA-e-2118 7
“Please note the accompanying documents”
or “Please note operating instructions”
„Observe operating instructions”
„Observe operating instructions
Kern & Sohn GmbH
Ziegelei 1,
72336 Balingen, Germany
www.kern-sohn.com
Identification of manufacturer of medical product
including address
Electro-medical appliance
with attachment for type B
Device protection category II
Dispose of old appliances separately from your
household waste!
Instead, take them to communal collection points.

8 TMBA_B-BA-e-2118
12 V DC / 500 mA
Display of supply voltage for scales with polarity display
Supply voltage direct current
Information
To prevent babies lying on the weighing pan from falling
off the scale, they must be watched all the time. Please
observe note on weighing pan!
Level balance before use

TMBA_B-BA-e-2118 9
3 Appliance overview
1. Height measuring rod (optional)
2. Baby weighing pan
3. Keyboard
4. LED
5. Bubble level
6. Mains connection
7. Rubber feet (height adjustable)
8. Battery compartment / adjustment switch inside
9. Not documented

10 TMBA_B-BA-e-2118
3.1 Dimensions
3.2 Overview of display
Display Designation Description
GROSS Gross weight display Illuminated when gross weight of the
baby is displayed
NET Net weight display Illuminated when net weight of the baby
is displayed
Illuminated after weighing scale was
tared
TARE Taring display Illuminated after weighing scale was
tared
Zeroing display Should the balance not display exactly
zero despite empty scale pan, press the
button. Your balance will be set to
zero after a short standby time.

TMBA_B-BA-e-2118 11
Stability display Scales are in a steady state
W1 – W2 Display weighing range Illuminated, when the load is within the
displayed range
HOLD HOLD function Is displayed with active Hold function
Rechargeable battery
symbol
Lights when the voltage drops below the
prescribed minimum.
Lights when the rechargeable battery
capacity is almost exhausted.
Illuminated when the rechargeable
battery is fully charged.

12 TMBA_B-BA-e-2118
3.3 Keyboard overview
Button Designation Function
ON/OFF-button Turn on/off
For numeric entry:
•Decimal point further to the right
In menu:
•Confirm selection
HOLD button Hold function
For numeric entry:
•Decimal point further to the left
TARE-key/
Zeroing key
•Tare balance
•Weighing scale will be reset to „0.0“kg.
For numeric entry:
•Reduce numeric value
In menu:
•Call up menu
•Select menu items
PRINT button Printout the weighing value
For numeric entry:
•Increase numerical value
In menu:
•Select menu items

TMBA_B-BA-e-2118 13
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
Indication
Determining the body weight in the medical practice area.
Operated as “Non-automatic weighing instrument” which
means that you have to carefully put the baby in the centre of
the weighing pan. Once a steady display value is shown, you
can read the weight value.
Contraindication

No contraindication known
4.2 Intended use
These balances serve as a means of determining the weight of babies in medical
treatment rooms (hospitals or Doctor practices). The frequently used function of the
baby scale is recognising, preventing and controlling illnesses.
Scales fitted with a serial interface may only be connected to
appliances in compliance with Directive EN60601-1.
To prevent babies lying on the weighing pan from falling off the
scale, they must be watched all the time. Please observe note on
weighing pan!

14 TMBA_B-BA-e-2118
4.3 Improper 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 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 scale is for weighing baby only. Any person with weight over
15 kg, do not step on the scale.
Improper use of optional height meter MBA-A01:
The structure of the height measuring rod may not be modified.
This may result in incorrect measuring results, safety-related
defects as well as destruction.
The height measuring rod
may only be used according to the
described conditions. Other areas of use must be released by
KERN in writing. More details in the instruction manuals of the
height meter.
4.4 Warranty
Warranty claims shall be voided in case of
Our conditions in the operation manual are ignored
The appliance is used outside the described uses
The appliance is modified or opened
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 the balance

TMBA_B-BA-e-2118 15
4.5 Monitoring of Test Resources
In the framework of quality assurance the measuring-related weighing properties of
the balance 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
the monitoring of balance test substances 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.
For balances with height measuring rods, we recommend a metrological examination
of the accuracy of the height measuring rod, however, this is not mandatory as the
determination of human body height involves rather large, intrinsic inaccuracies.

16 TMBA_B-BA-e-2118
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.
5.3 Preventing contamination
To prevent cross-contamination (fungal skin infections, ….,) clean the baby
weighing pan or weighing platform every time after weighing.
Recommendation: After any weighing procedure that could potentially result in
contamination (e. g. after weighing that involves direct skin contact).
5.4 Preparing for use
•Check the balance for damage before any use
•Maintenance and re-verification
The baby scale must be serviced and re-verified at regular intervals. (see
chapter 12.4)
•Do not use the device on slippery surfaces or in rooms susceptible to
vibrations
•The balance must be levelled during installation
•If possible, the product must be transported in its original packaging when
transporting. If this is not possible, ensure that the product is protected from
damage.

TMBA_B-BA-e-2118 17
6 Electromagnetic compatibility (EMC)
6.1 General hints
The MBA-M is suitable for professional healthcare facility environments (hospital,
clinics…).
The installation and use of this electrical medical device requires
special precautionary measures as outlined in the EMC information
below.
Don’t near active HF surgical equipment and the RF shielded room of
an ME system for magnetic resonance imaging, where the intensity of
EM disturbances is high.
Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the equipment MBA-M, including
cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Note：The emissions characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the
equipment.
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
emitted by connecting cables or the air.

18 TMBA_B-BA-e-2118
Inadmissible disturbances from the environment may result in incorrect displays,
inaccurate measured values or incorrect behaviour of the medical device. The line
regulation is less than ±1kg unstable readings while measuring at rated weight
capacity.
Also in certain cases the baby scale MBA-M may cause such failures 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 baby scale MBA-M on a place.
•Connect the baby scale MBA-M to another power source.
•For further questions please contact our customer services.
Disturbances may be caused by improper modification or add-ons to the device or
not recommended accessories (such as power units or connecting cables). The
manufacturer will not be responsible for these. Modifications may also result in a loss
of authorisation relating to the use of the device.
Devices emitting high frequency signals (mobile telephones, radio transmitters, radio
receivers) may cause interference in the medical device. For that reason do not use
them near the medical device. Chapter 6.4 contains details about recommended
minimum distances.

TMBA_B-BA-e-2118 19
6.2 Electromagnetic interferences
All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE with regard to electromagnetic disturbances for the excepted
service life. (description according to the product from the manufacturer)
Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity
Use below tables for product using mains power
Guidelines and manufacturer’s declaration – electromagnetic emissions
The baby scale MBA-M is intended to be operated in an electromagnetic environment as defined
below. The customer or user of the baby scale MBA-M should ensure that operation takes place in
such an environment.
Emissions test
Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class [A]
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/ flicker
IEC 61000-3-3
Comply
Do not put the baby scale MBA-M directly next to other devices and do not stack it
with other devices. If this type of operation is necessary, observe the baby scale
MBA-M to ensure normal operation in such an arrangement.
6.2.1 Degradation of performance
Strong fields of electromagnetic interferences caused for example by
electric motors or inductive charging devices may lead to degradation of
performance when placed next to the baby scale MBA-M. Degradation of
performance may lead to unstable displayed weighing values.

20 TMBA_B-BA-e-2118
6.3 Electromagnetic noise immunity
Guidelines and manufacturer’s declaration - electromagnetic immunity
The baby scale MBA-M is intended to be operated in an electromagnetic environment as defined
below. The customer or user of the baby scale MBA-M should ensure that operation takes place in
such an environment.
Immunity tests
IEC 60601-1-2
Test level
Compliance level
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15kV air
±8 kV contact
±2 kV,±4 kV, ±8kV, ±15kV air
Electrical fast transient /
burst
IEC 61000-4-4
±2 kV for power supply lines
+ 1 kV signal input/output
100kHz repetition frequency
±2 kV for power supply lines
Not applicable
100kHz repetition frequency
Surge
IEC 61000-4-5
±0.5 kV, ±1 kV differential mode
±0.5 kV, ±1 kV, ±2 kV common
mode
±0.5 kV, ±1 kV differential mode
Not Applicable
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
0 % UT; 0,5 cycle. At 0°, 45°, 90°,
135°, 180°, 225°, 270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase: at 0°.
0 % UT; 250/300 cycle
0 % UT; 0,5 cycle. At 0°, 45°, 90°,
135°, 180°, 225°, 270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase: at 0°.
0 % UT; 250/300 cycle