KERN MBC 15K2DNM User manual

KERN & Sohn GmbH
Ziegelei 1
D-72336 Balingen
E-Mail: [e-mail]
Tel: +49-[0]7433- 9933-0
Fax: +49-[0]7433-9933-149
Internet: www.kern-sohn.com
Operating instructions
Baby scale
KERN MBC
MBC 15K2DNM
MBC 20K10NM
MBC 15K2DEM
MBC 20K10EM
Version 4.1
2018-11
GB
MBC_NM-BA-e-1841
Importør:
Impex Produkter AS
Gamle Drammensvei 107
1363 Høvik
www.impex.no
[email protected]
Tel.: [phone]

2 MBC_NM-BA-e-1841
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MBC_NM-BA-e-1841 3
GB
KERN MBC
Version 4.1 2018-11
Operating instructions
Baby scale
Contents
1Technical data................................................................................................ 5
2Declaration of conformity ............................................................................. 7
2.1 Explanation of the graphic symbols for medical devices.................................................... 7
3Appliance overview ..................................................................................... 10
3.1 Overview of display................................................................................................................ 11
3.2 Keyboard overview................................................................................................................. 12
4Basic Information (General)........................................................................ 13
4.1 Specific function..................................................................................................................... 13
4.2 Proper use............................................................................................................................... 13
4.3 Improper Use .......................................................................................................................... 14
4.4 Warranty.................................................................................................................................. 14
4.5 Monitoring of Test Resources............................................................................................... 14
5Basic Safety Precautions............................................................................ 15
5.1 Pay attention to the instructions in the Operation Manual................................................ 15
5.2 Personnel training.................................................................................................................. 15
5.3 Preventing contamination ..................................................................................................... 15
5.4 Appropriate use...................................................................................................................... 15
6Electromagnetic compatibility (EMC)......................................................... 16
6.1 General hints........................................................................................................................... 16
6.2 Electromagnetic interferences.............................................................................................. 17
6.3 Electromagnetic noise immunity.......................................................................................... 18
6.3.1 Crucial features of performance............................................................................................... 20
6.4 Minimum distances................................................................................................................ 20
7Transport and storage................................................................................. 21
7.1 Testing upon acceptance ...................................................................................................... 21
7.2 Packaging / return transport ................................................................................................. 21
8Unpacking, Setup and Commissioning ..................................................... 22
8.1 Installation Site, Location of Use.......................................................................................... 22
8.2 Unpacking ............................................................................................................................... 22
8.3 Scope of delivery.................................................................................................................... 23
8.3.1 Modelle MBC-NM..................................................................................................................... 23
8.3.2 Modelle MBC-EM ..................................................................................................................... 23
8.4 Placing..................................................................................................................................... 24
8.5 Rechargeable battery operation (MBC-A08)........................................................................ 25
8.6 Battery operation.................................................................................................................... 26
8.7 Mains connection (MBC-NM)................................................................................................. 27

4 MBC_NM-BA-e-1841
8.8 Optional power supply units................................................................................................. 27
8.9 Initial Commissioning ............................................................................................................ 27
9Operation...................................................................................................... 28
9.1 Weighing ................................................................................................................................. 28
9.2 Taring....................................................................................................................................... 28
9.3 Hold function (Standstill function) ....................................................................................... 29
9.4 Feeding function (control of weight gain)............................................................................ 29
9.5 Show another decimal place (not verified value)................................................................ 30
9.6 Use the optional size measurement device MBC-A01........................................................ 30
10 Menu ............................................................................................................. 31
10.1 Navigation in the menu.......................................................................................................... 31
10.2 Menu overview........................................................................................................................ 32
11 Error messages............................................................................................ 34
12 Service, maintenance, disposal.................................................................. 35
12.1 Cleaning .................................................................................................................................. 35
12.2 Cleaning/Disinfection............................................................................................................. 35
12.3 Sterilisation............................................................................................................................. 35
12.4 Service, maintenance............................................................................................................. 35
12.5 Disposal................................................................................................................................... 35
13 Instant help................................................................................................... 36
14 Verification................................................................................................... 37
14.1 Verification validity period (current status in G)................................................................. 38
15 Adjustment................................................................................................... 39
16 Accessories (optional) ................................................................................ 41

MBC_NM-BA-e-1841 5
1 Technical data
KERN (Type) MBC 15K2DNM MBC 20K10NM
Model MBC 15K2DM MBC 20K10M
Weighing range (max) 6 kg / 15 kg 20 kg
Minimum load (Min) 40 g / 100 g 200 g
Readability (d) 2 g / 5 g 10 g
Verification value (e) 2 g / 5 g 10 g
Reproducibility 2 g / 5 g 10 g
Linearity ± 2 g / 5 g 10 g
Display LCD with 25mm high digits
Recommended adjustment
weight, not added (class) 15 kg
(M1) 20 kg (M1)
Stabilization time (typical) 3 sec.
Warm-up time 10 min
Operating temperature 10° C …. + 40° C
Humidity of air max. 80 % (not condensing)
Input Voltage 100 V - 240 V, 50 / 60 Hz
Auto Off After “x“ min adjustable without load change
Dimensions fully mounted
(W x D x H) mm
890 x 470 x 175
(with integrated height measuring device)
600 x 407 x 120
(without height measuring device)
Dimensions display unit (W
x D x H) mm 200 x 130 x 60
Baby weighing pan
(WxD) mm 600 x 280 x 55
Weight kg (net) 4,6
Rechargeable battery
operation, optional MBC-A08, internally
6x1.2 V 2000 mA
Verification according to
2014/31/EU Grade III
Medical product in
accordance with 93/42/EEC Category I with measuring function
Height measuring device,
integrated MBC-A01, Measuring range: 40 - 80 cm

6 MBC_NM-BA-e-1841
KERN (Type) TMBC 15K2DEM-A TMBC 20K10EM-A
Model MBC 15K2DEM MBC 20K10EM
Weighing range (max) 6 kg / 15 kg 20 kg
Minimum load (Min) 40 g / 100 g 200 g
Readability (d) 2 g / 5 g 10 g
Verification value (e) 2 g / 5 g 10 g
Reproducibility 2 g / 5 g 10 g
Linearity ± 2 g / 5 g 10 g
Display LCD with 25mm high digits
Recommended adjustment
weight, not added (class) 15 kg
(M1) 20 kg (M1)
Stabilization time (typical) 3 sec.
Warm-up time 10 min
Operating temperature 10° C …. + 40° C
Humidity of air max. 80 % (not condensing)
Input Voltage 100 V - 240 V, 50 / 60 Hz
Auto Off After “x“ min adjustable without load change
Dimensions fully mounted
(W x D x H) mm
890 x 470 x 175
(with integrated height measuring device)
600 x 407 x 120
(without height measuring device)
Dimensions display unit (W
x D x H) mm 200 x 130 x 60
Baby weighing pan
(WxD) mm 600 x 280 x 55
Weight kg (net) 4,6
Rechargeable battery
operation, optional MBC-A08, internally
6x1.2 V 2000 mA
Batteries 6 x 1.5 V AA
Verification according to
2014/31/EU Grade III
Medical product in
accordance with 93/42/EEC Category I with measuring function
Height measuring device,
integrated MBC-A01, Measuring range: 40 - 80 cm

MBC_NM-BA-e-1841 7
2 Declaration of conformity
To view the current EC/EU Declaration of Conformity go to:
www.kern-sohn.com/ce
The scope of delivery for calibrated weighing balances
(= conformity-rated weighing balances) includes a Declaration of Conformity.
Solely these weighing balances are classified as medical devices.
2.1 Explanation of the graphic symbols for medical devices
All medical scales marked in this way meet the requirements
of the following directives:
1. 2014/31/EU: Directive on non-
automatic weighing
instruments
2. 93/42/EC: Directive concerning medical devices
Scales marked in this way underwent the conformity
assessment procedure according to Directive 2014/31/EU for
scales belonging to 3rd accuracy class.
WF 172795
Designation of the serial number of every device,
applied at the device and on the packaging
(Number as an example)
2019-02
Identification of the manufacturing date of the medical
product.
(Year and month here as example)

8 MBC_NM-BA-e-1841
“Please note the accompanying documents“
or “Please note operating instructions”
“Please note operating instructions”
“Please note operating instructions”
Kern & Sohn GmbH
D–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.
12 V DC / 500 mA
Display of supply voltage for scales with polarity display.

MBC_NM-BA-e-1841 9
Direct current supply voltage
Information
In order to avoid accidents, babies placed on the scales
shall be continuously observed. Proceed in accordance
with the indications specified on the scale!
Transportation protection
Power supply socket is marked with a small label on the
side of the display
Level the scales before use

10 MBC_NM-BA-e-1841
3 Appliance overview
1. Height measuring rod (optional)
2. Bubble level
3. Display Unit
4. LED
5. Baby weighing pan
6. Weighing pan
7. Rubber feet (height adjustable)
8. Mains connection (MBC-NM)
9. Battery compartment
10.RS232

MBC_NM-BA-e-1841 11
3.1 Overview of display
Display Description Description
GROSS Gross weight display Lights up during indication of the gross
weight of the baby (after drinking)
NET Net weight display Lights up during indication of the net weight
of the baby (before drinking)
Illuminated after weighing scale was tared
ZERO 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.
STABLE Stability display Scales are in a steady state
DRINK DRINK function Is displayed with active drink function
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.
Lights when the rechargeable battery is fully
charged.

12 MBC_NM-BA-e-1841
3.2 Keyboard overview
MBC 15K2DNM MBC 15K2DEM
MBC 20K10NM MBC 20K10EM
Key Description Function
ON/OFF-switch Turn on/off
Zeroing key Weighing scale will be reset to „0.0“ kg.
For numeric entry:
•Change decimal place
HOLD button Hold function
TARE button Tare balance
Feeding Function
key Differential weighing before and after the baby drinks
The net weight of the baby will be shown:
Before drinking
In menu:
•Call up menu
•How to select menu items
For numeric entry:
Edit numeric value
The gross weight is displayed:
After drinking
In menu:
Confirm selection
For numeric entry:
Confirm numerical value

MBC_NM-BA-e-1841 13
4 Basic Information (General)
Weighing instruments 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 he baby in the centre of
the weighing pan. Once a steady display value is shown, you
can read the weight value.
Contra-
indication
No contraindication known
4.2 Proper use
These scales serve as a means of determining the weight of babies in medical
treatment rooms. The scales are suitable for 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 MBC_NM-BA-e-1841
4.3 Improper Use
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.
4.4 Warranty
Warranty claims shall be voided in case
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
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.

MBC_NM-BA-e-1841 15
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 a weighing procedure that could potentially result in
contamination (e. g. after weighing that involves direct skin contact).
5.4 Appropriate use
•Before every use inspect the scales for any signs of damage.
•Maintenance and repeated verification
Medical scales should be maintained and verified at regular intervals. (see
Chapter 12.4)

16 MBC_NM-BA-e-1841
6 Electromagnetic compatibility (EMC)
6.1 General hints
The installation and use of this baby scale MBC-NM requires special
precautionary measures as outlined in the EMC information below.
This device complies with the limits set for medical electrical devices of group 1,
class B (as per EN 60601-1-2).
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.
Inadmissible disturbances from the environment may result in incorrect displays,
inaccurate measured values or incorrect behaviour 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:

MBC_NM-BA-e-1841 17
•Change the alignment or distance of the device to the source of EMI.
•Install or use the baby scale MBC-NM at a different location.
•Connect the baby scale MBC-NM to a different 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.
6.2 Electromagnetic interferences
Guidelines and manufacturer’s declaration – electromagnetic interferences
The baby scale MBC-NM is designed for use in an electromagnetic environment that meets the
requirements stated below. The customer or user of the medical electrical device must ensure that
operation takes place in such an environment.
Emitted interference
measurements
Conformity
Electromagnetic environment -
guideline
HF emissions
as per CISPR 11 / EN 55011
Group 1
The baby scale MBC-NM uses HF
energy merely for its internal working.
Its HF emission therefore is very low
and it is highly unlike to interfere with
adjacent electronic devices.
HF emissions
as per CISPR 11 / EN 55011
Class B
The baby scale MBC-NM is designed
for use in all equipment including
those in living areas and those
connected directly to the public power
grid that also supplies buildings used
for living purposes.
Emission of harmonics
as per IEC 61000-3-2
Class A
Emission of voltage fluctuations /
flicker
as per IEC 61000-3-3
Conforms with
Do not put the baby scale MBC-NM directly next to other devices and do not stack it
with other devices. If this type of operation is necessary, observe the baby scale
MBC-NM to ensure normal operation in such an arrangement.

18 MBC_NM-BA-e-1841
6.3 Electromagnetic noise immunity
Guidelines and manufacturer’s declaration - electromagnetic noise immunity
The baby scale MBC-NM is designed for use in an electromagnetic environment that meets the
requirements stated below. The customer or user of the medical electrical device must ensure that
operation takes place in such an environment.
Noise immunity tests
IEC 60601 test level
Conformity
Electromagnetic
environment - guideline
Discharge static
electricity (DSE)
as per IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV
± 8 kV
Floors should be made of
wood or concrete or tiled with
ceramic tiles. If floors are
covered with synthetic
material, relative air humidity
must be at least 30%.
Fast transient electrical
disturbances / bursts
as per IEC 61000-4-4
± 2 kV for power lines
+ 1 kV for input and
output lines
± 2 kV
+ 1 kV
The quality of the supply
voltage should match that of
the typical business or hospital
environment.
Impulse voltages /
surges
as per IEC 61000-4-5
± 1 kV voltage
Live wire - live wire
± 2 kV voltage
Live wire - earth
± 1 kV
Inapplicable
The quality of the supply
voltage should match that of
the typical business or hospital
environment.
Voltage dips, short-term
disruptions and
fluctuations in supply
voltage
as per IEC 61000-4-11
< 5 %
(> 95 % dip of )
for ½ period
40 %
(> 60 % dip of )
for 5 periods
70 %
(> 30 % dip of )
for 25 periods
< 5 %
(> 95 % dip of )
for 5 s
Compliance
with
requirements
under all
postulated
conditions
Controlled
switch off
Return to
undisturbed
situation after
user
intervention.
The quality of the supply
voltage should match that of
the typical business or hospital
environment. Where the user
of the baby scale MBC-NM
demands continuous operation
even during disruptions to the
power supply, we recommend
powering the baby scale MBC-
M by no-break power supply or
battery.
Magnetic field for supply
frequency
(50/60 Hz)
as per IEC 61000-4-8
3 A/m
3 A/m
50/60 Hz
Magnetic fields for the supply
frequency should match the
typical values found in the
particular business or hospital
environment.
NOTE equals AC line voltage prior to application of test level.

MBC_NM-BA-e-1841 19
Guidelines and manufacturer’s declaration - electromagnetic noise immunity
The baby scale MBC-NM is designed for use in an electromagnetic environment that meets the
requirements stated below. The customer or user of the medical electrical device must ensure that
operation takes place in such an environment.
Noise immunity tests
IEC 60601 test
level
Conformity
Electromagnetic environment -
guideline
Conducted HF
disturbance variables
as per IEC 61000-4-6
3
150 kHz to 80 MHz
3 V
Do not use portable or mobile radio sets
nearer to the baby scale MBC-NM or its
wires than the distance recommended
as safety distance which is calculated
according to the equation relevant for its
transmission frequency.
Recommended safety distance:
for 80 MHz to 800 MHz
for 800 MHz to 2.5 GHz
Use P as rated capacity of radio
transmitter in Watt (W) as per details
given by the radio transmitter
manufacturer and d as recommended
safety distance in metres (m).
The field intensity of stationary radio
transmitters should for all frequencies be
lower according to an in situ a
examination than the conformity level.b
Interference may occur near devices
bearing the symbol below.
Emitted HF
disturbance variables
as per IEC 61000-4-3
3
80 MHz to 2.5 GHz
3 V/m
NOTE 1 Higher frequency range applies to 80 MHz and 800 MHz.
NOTE 2 These guidelines may not be applicable in all cases.
The spread of electromagnetic variables is influenced by absorption and reflections in
buildings, objects and humans.
aThe field intensity of stationary radio transmitters such as base stations of wireless telephones and
mobile radio sets, amateur radio stations, AM and FM radio and television stations cannot be reliably
predicted in advance. To determine the electromagnetic environment in respect of stationary
transmitters, you should consider a study of electromagnetic phenomena at the location. If the
measured field intensity at the location where the baby scale MBC-NM is to be used exceeds the
conformity level above, you should observe the baby scale MBC-NM in order to ensure normal
operation. If you observe unusual features of performance you may have to take additional measures
such as a change in alignment or a different location for the baby scale MBC-M.
b
For a frequency range of 150 kHz to 80 MHz field intensity should be less than 3 V/m.

20 MBC_NM-BA-e-1841
6.3.1 Crucial features of performance
The baby scale MBC-NM does not have any crucial features of
performance as per IEC 60601-1. The system may be subject to
interference by other devices even if these devices conform to current
emission requirements as per CISPR.
6.4 Minimum distances
Recommended safety distances between portable and mobile HF
telecommunication devices and the medical device
The baby scale MBC-NM is designed for use in an electromagnetic environment in which HF
disturbance variables are controlled. The customer or user of the medical electrical device can help
avoiding electromagnetic disturbances by keeping the minimum distance between portable and mobile
HF telecommunication devices (transmitters) and the medical device – depending on the output
performance of the communication device, as stated below.
Rated capacity of
transmitter
W
The safety distance depends on the transmission frequency
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.20
1.20
2.30
10
3.80
3.80
7.30
100
12.00
12.00
23.00
For transmitters with a maximum rated capacity not stated in the table above you can calculate the
recommended safety distance in metres (m) yourself by using the equation belonging to each column,
whereby P equals the maximum rated capacity of the transmitter in Watt (W) as per details provided
by the transmitter manufacturer.
NOTE 1 Higher frequency range applies to 80 MHz and 800 MHz.
NOTE 2 These guidelines may not be applicable in all cases.
The spread of electromagnetic variables is influenced by absorption and reflections in
buildings, objects and humans.