nanny BM-03 User manual

BM-03 Baby breathing monitor
Certified medical device

44
MXA51005
EN | Baby breathing monitor
1. Product identification
2. Functions and controls
2.1 Main functions - breathing monitor
2.2 Supplementary functions
2.2.1 Detecting whether the baby has been placed on the sensor pad or taken
off it (Switch Guard)
2.2.2 Night light
2.2.3 Monitoring room temperature
2.2.4 Day and Night mode
3. Installation
4. In situ monitor usability test
5. Power supply and replacing the batteries
6. Sensor pad
6.1 Life span of the sensor pad
7. Maintenance and cleaning
8. Alarm states
9. Operator warning
10. Important warning
11. Problems and how to solve them
12. Technical specifications
13. Definitions and symbols
14. EMC of a medical device
14.1 EMISSIONS limits by environment
14.2 Immunity requirements - input and output through the device’s cover
14.3 Immunity requirements - input and output through the device’s cover from RF
devices
CONTENTS
Prior to using the BM-03 Breathing Monitor, please read the instruc-
tions for use and the conditions of its use carefully, as well as the
general procedures of first aid and emergency care for children!
If you have any questions about using the monitor, please refer to the
contacts provided in this manual.

MXA51005
45
EN
1. PRODUCT IDENTIFICATION
Package contents:
1. control unit,
2. sensor pad with connecting cable,
3. 2x alkaline batteries,
4. accessories - clip for hanging,
5. accessories - Velcro,
6. accessories - control unit holder,
7. accessories - stand.
The BM-03 Baby Breathing Monitor is a certifi ed Class IIb medical device that
monitors a baby’s breathing. It cannot be used to restore vital functions and is not
a therapeutic device. It does not replace proper childcare.
It is intended for use by health care providers and for care in the home environment.
The product is intended to provide a warning, by an optical and acoustic warning, that
the respiration has stopped or the respiration rate has decreased. It thus warns of the
possible danger of respiratory arrest that may occur in young infants (for example, due
to sudden infant death syndrome - SIDS) or due to other causes
(suffocation, an illness, etc.).
Due to the nature and purpose of use, no side effects and other contraindications are
known.
The device is not intended for:
• direct contact or transferred contact with the child’s body,
• for monitoring two children at once (for example, twins).
Basic characteristics of the monitor:
• a warning during sudden infant death syndrome or other causes of respiratory
arrest;
• health care at home and in a hospital (can be used in an incubator);
• for children over 1 kg;
• does not affect or restrict the child’s movement;
• maximum reliability - automatically tests its functionality every time it’s turned on
and detects the baby’s position;
• powered by 2 AA batteries (included);
• easy to use, does not require special maintenance or calibration;
• indicates an uncomfortable room temperature;
• night light;
• Day and Night mode to give you a quiet night’s sleep;
• easily portable.
Fig. 2 Package contents
1. 2. 3. 4. 5. / 6. 7.

46
MXA51005
EN | Baby breathing monitor
2. FUNCTIONS AND CONTROLS
1. mechanical on/off button for the monitor
2. optical breathing/alarm signal
3. the NANNY logo works as a capacitive button for light control
4. speaker
5. the indicator light with the power-on symbol - signaling of laying down/
removing the baby, switching from standby to active mode and back or mechanical
button jam
6. low battery indicator
7. room temperature indicator
8. lamp light
9. sockets for the sensor pad cable connector
2.1 MAIN FUNCTIONS - BREATHING MONITOR
Based on signals from the sensor pad located under the baby, the device monitors the
regularity of breathing and signals respiratory arrest.
Inhalation and exhalation are indicated by a green fl ash around the monitor’s
mechanical on/off button. The alarm consists of an intense red fl ash around the
mechanical button and a loud acoustic alarm.
The alarm will go off if:
A) No inhalation is detected for 20 secs. 17 secs after the last breath is detected,
a pre-alarm is triggered and the alarm then goes off.
B) The breathing rate is less than 8 breaths per minute. In this case, the alarm goes
off immediately (with no pre-alarm).
Fig. 3 Control unit - functions
and symbols
Fig. 4 Control unit - bottom section
1.
2.
3.
4.
5.
6.
9.
8.
7.

MXA51005
47
EN
The alarm can be turned off by pressing the mechanical on/off button.
The monitor operates in active and standby mode. In active mode, the monitor detects
the baby’s breathing movements and additional functions are activated. In standby
mode, the monitor is switched to power saving mode and the unit evaluates the signals
from the pad to be able to draw attention to a baby being placed there.
A quiet beep indicates switching to standby mode.
If the button is constantly pressed it is a defect. If this fault is detected during the
automatic test after switching from standby mode, the control unit will not start. If a
mechanical button fault is detected in active mode, a critical failure will be reported
visually and acoustically. Release the mechanical button to remove the fault.
Automatic functionality test
When switching from standby to active mode or when inserting the batteries, the
device automatically tests its functionality. The test checks the batteries, the correct
type of pad is connected and its age, the optical and acoustic signal, the notifi cation
for the on/off switch being in the incorrect state for the baby’s current absence or
presence.
Functionality test results:
A) All indicators fl ash and short beep = all checks were successful and the device
is fully functional.
B) Flashing lights and repeated warning beeps = error diagnosed but it does not
prevent the monitor from being used and maintaining its functionality.
C) Repeated warning beeps and the device does not switch on = a critical fault has
been detected (critically low battery), the device cannot be used. Correct the error
(insert new batteries), then the device can be used again. If the error persists, send
the monitor for a service.
2.2 SUPPLEMENTARY FUNCTIONS
2.2.1 DETECTING WHETHER THE BABY HAS BEEN PLACED ON THE SENSOR PAD OR
TAKEN OFF IT (SWITCH GUARD)
When in standby mode the BM-03 Baby Breathing Monitor continuously evaluates
signals from the pad and is thus the only device on the market today to point out that
the baby was most likely placed on the sensor pad. This prevents tragic consequences
if a parent or other caregiver forgets to turn on the device and the baby stops
breathing.
It can also warn parents or other caregivers if they remove a baby from the cot and
forget to turn off the device.
.
Type of warning Acoustic indication
None – the device is fully functional 1x beep
The Switch Guard function is deactivated 2x beep
Connected a sensor pad or control unit with possibly
exceeded life span 3x beep

48
MXA51005
EN | Baby breathing monitor
Turning the Switch Guard function off and on
The baby location detection function is switched on by default. If you want to turn this
feature off or on again, press the mechanical button before inserting the batteries,
then insert the batteries and keep the button pressed. After 10 secs, deactivation
or reactivation is confirmed by a beep and the indicator light with the button symbol
flashing.
If the Switch Guard function is deactivated, a warning beep will sound twice at the end
of the automatic test.
Removal detection
If a parent or other caregiver removes a baby from the cot and forgets to switch
off the device, the orange light with the button symbol will flash after 10 seconds and
a quiet beep will sound. If the device is not switched off, a pre-alarm will sound after
17 secs from the last detection and then the alarm.
2.2.2 NIGHT LIGHT
For your convenience, the breathing monitor is equipped
with a light, which is mainly used to check on the baby
at night.
Activation and deactivation of the light function
The lamp function is deactivated by default. To activate it,
simultaneously press the mechanical button and the
lamp’s capacitive switch, which is located in the middle
of the NANNY logo (Fig. 5a), for 10 secs. After activation,
the lamp flashes three times.
The light function can be deactivated in the same way.
The activation and deactivation of the light function can
be done only in the standby mode. The light function
is completely deactivated if the batteries are low, except
if there is an alarm in night mode.
Fig. 5a - Activating/deactivating
the light function
To switch on the device, the user must press the mechanical button, the
device will not automatically switch from standby to active mode.
Warning when the monitor is not turned on
If a parent or other caregiver places a baby in the cot but forgets to turn on the
monitor, the orange light with the button symbol (symbol no. 5 in Fig. 3) will flash
and a short quiet beep will sound after 30 seconds. The light flashes whilst
the device evaluates the excitation on the pad, but the device is not turned on.

MXA51005
49
EN
2.2.3 MONITORING ROOM TEMPERATURE
The control unit is equipped with a temperature sensor to measure the quality of
the environment. It serves to indicate the room is overheating, which may be one of
the causes of sudden infant death syndrome. The device can thus indicate a room
temperature that is quite likely uncomfortable, however, responsibility for the
temperature and quality of the environment lies with the parent or other caregiver
(monitor operator).
The temperature range is indicated by the light with the thermometer symbol flashing:
Flashing blue = the room temperature is below 16.5 °C. It is a cooler environment, but
it may be comfortable for you and your baby.
Flashing orange = room temperature is higher than 28 °C. It is advisable to reduce
it, for example by airing or turning down the heating, to prevent the baby from
overheating.
2.2.4 DAY AND NIGHT MODE
The device is equipped with an optical sensor to detect day and night, or darkness.
Thanks to this, the light diodes light up at night with a lower intensity than during the day
to ensure parents or other caregivers have a good night’s rest.
Day and Night mode switches automatically.
Switching the light on and off
The light is switched on and off using the capacitive
switch located below the NANNY logo (symbol no. 3
in Fig. 3). The light is switched on and off by touching
the light’s capacitive switch which is located in the middle
of the NANNY logo. Place your fingertip on the center
of the NANNY logo and leave it attached for at least 1
second (Fig. 5b). There is no need to press the switch, just
place your finger on the surface.
The light is on for a period of 30 secs. If you place your
finger on the capacitive switch again within 20 seconds
of switching on, the lamp goes out.
After 20 secs, the lamp will gradually dim. If you place
your finger on the capacitive switch again as it dims,
the light will be restored for another 30 secs, otherwise
it will go out after 30 secs.
If the alarm is triggered in night mode, the lamp will turn
on automatically.
Fig. 5b – Switching the light on
and off

50
MXA51005
EN | Baby breathing monitor
2. Route and secure the connecting cable
so that the child cannot pull on it and it does
not form loose sections or loops. If you do not
use the entire length of the cable, roll up the
unused part and tighten it tightly with a tie
wire. Keep the roll out of the reach of children.
Fig. 7 Securing the connecting
cable
3. Remove the battery cover and insert the
batteries. The battery compartment has
the polarity marked inside for inserting the
battery.
Fig. 8 Inserting the batteries
4. Connect the connecting cable to any socket
in the control unit. The connector must click
and hold when inserted.
Fig. 9 Connecting the connecting cable
to the control unit
Neither the sensor pad nor the control unit need to be specially cleaned or disinfected
after unpacking. Before using the monitor, make sure that all parts are undamaged.
The device does not require temperature adaptation in connection with its installation
and subsequent repeated use.
1. Place the sensor pad under the
mattress together with a suitable insulating
layer against liquid penetration in the places
where the baby will be lying. The pad must
be placed on a flat surface with the top print
facing up and must not be bent. If the cot
only has a slat base, support the pad with
a solid board. The board does not have to
cover the entire lower part of the bed - it is
enough if it exceeds the area of the pad by
about 3 cm on each side.
Fig. 6 Location of the sensor pad
3. INSTALLATION

MXA51005
51
EN
5. For your convenience, you can hold the control unit with various accessories:
• a cot holder and Velcro - you can tighten the Velcro to the circumference of the
upper edge of the cot;
• holder and double-sided adhesive tape to place it on the side of furniture or another
solid surface;
• cot clip;
• a stand for the control unit - it can be placed, for example, on the bedside table
next to the bed.
Fig. 10 Holder and Velcro Fig. 11 Holder and adhesive tape
Always make sure that you can hear the control unit.
6. Perform a usability test at the installation site - see next section.
The monitor is then ready for use.
Fig. 12 Cot clip Fig. 13 Stand

52
MXA51005
EN | Baby breathing monitor
4. IN SITU MONITOR USABILITY TEST
We recommend performing the usability test daily, but at least when
changing the location of the bed or monitor.
• Make sure the green light flashes while the baby is in the cot. The green light reacts
by flashing with the baby’s breathing or movements. The flashing of the light may
not be regular - the frequency corresponds to the baby’s movements or breaths.
• Then take the baby out of the cot and move away from the cot. Wait a while for the
vibrations from your movements and the mattress to subside.
• If a pre-alarm sounds after 17 secs and an alarm after 20 secs, the monitor has
passed the usability test and can be fully relied upon. Verify that the alarm sound
can be heard in all areas where the parents or other caregivers are present.
If the green light flashes even when the baby is not in the crib, the
monitor is detecting disturbance in the surroundings. Surrounding
shocks or vibrations with a similar frequency can be falsely evaluated
by the device as the baby’s breathing / movements, therefore they
must be eliminated in order to ensure the device works reliably and
the baby is safe! Disturbance can be caused by intense airflow
(fans, air conditioning), walking near the bed, mechanical vibration
from household appliances, etc. Eliminate disturbance in the
surroundings or relocate the cot!
The device is powered by two alkaline 1.5 V/AA batteries and monitors their power.
The device distinguishes between low and critical battery level.
Low battery is indicated by a flashing red light with a picture of a battery. All
functions except the lamp are retained. The low battery indication lasts for about 2
weeks before the batteries are completely empty, so you have enough time to replace
them. The batteries must be replaced as soon as possible after the red low battery
indicator comes on.
In the event of a critically low battery, the fault is indicated audibly during the
automatic test and the device does not turn on. Replace both batteries immediately!
The batteries need changing depending on the intensity of use - usually after 4-12
months. Before replacing the batteries, switch off the device by pressing
the mechanical button. Remove the battery cover and remove the original batteries.
Remove the batteries when you are not using the monitor at all.
5. POWER SUPPLY AND REPLACING THE BATTERIES

MXA51005
53
EN
The sensor pad is included in the package. It can also be bought separately as a spare
part labelled BM-03D.
One sensor pad is enough until the baby is about 6 months old. If the baby starts to
climb or move in the cot, the monitored area can be enlarged by attaching a second
sensor pad. The control unit contains 2 sockets for connecting the sensor pads. The
sockets are identical, so the connector can be connected to either of them in any order.
The device will not be in active mode until at least one BM-03D sensor pad
is connected.
If any sensor pad is disconnected in active mode, the alarm is sounded immediately.
If the pad is disconnected in standby mode, a warning beep will sound and the red light
around the mechanical button will flash 3 times.
It is best to buy a set of 2 pads. The second pad can be used in multiple places in the
baby’s first months of life - for example, in another bed, at its grandparents, etc. In this
case, only the control unit is moved. When the baby grows up, the second pad can
be attached to the baby’s cot together with the original pad.
Both pads are connected to the sockets on the bottom of the control unit. Always keep
loose cables or loops out of reach of the baby.
6. SENSOR PAD
To monitor twins, a separate breathing monitor is needed for each
baby - so it is not possible to use the same control unit for 2 babies
at the same time, even though each will lie on its own mat. To use the
breathing monitor effectively, babies must always lie in their own cot,
otherwise the monitor may detect the other baby’s movements.
Fig. 14 Connecting two sensor
pads to the control unit
Fig. 15 Using two sensor pads

54
MXA51005
EN | Baby breathing monitor
As auxiliary data, the Nanny BM-03 breathing monitor also monitors the number of
hours the monitor has been in operation - if it is likely the pad has exceeded the
specifi ed life span, a warning beep will sound 3 times during each automatic test.
However, the date it is put into service is decisive for determining the life span.
The sensor in the pad may wear out over time, so it may not correctly sense your baby’s
movements and breathing. In this case, the monitor may give false alarms that will
cause you unnecessary worries. False alarms may not endanger your baby’s life
or health, but you will hear the alarm so often that you prefer to turn off the monitor
or reduce your alertness, which could endanger your child.
7. MAINTENANCE AND CLEANING
The device does not require any special maintenance other than replacing the batteries
and cleaning. We simply recommend that you check the sensor pad in the cot from
time to time to ensure moisture has not condensed where the pad touches
the mattress. It is advisable to turn the mattress 180 ° in the cot once in a while,
or turn it upside down or let it air, etc. Only use a slightly damp cloth for cleaning.
Avoid wet wipes or other materials that may have loose fi bres that can clog the holes
in the control unit.
It is not necessary to sterilize the breathing monitor when in medical facilities.
The device does not require sterilization or disinfection between use by different
patients. The device can be treated with commonly available disinfectants at
a concentration in line with the manufacturer’s recommendations for the given level
of disinfection. Keep in mind that moisture entering the battery compartment
or the control unit during cleaning can damage the device. Only use a cloth
dampened with disinfectant solution for disinfection and only wipe the device lightly.
The frequency of cleaning is not specifi ed by the manufacturer and the frequency
of cleaning does not affect the product’s life span. As concerns further
maintenance, the device does not have a measuring function to be calibrated.
6.1 LIFE SPAN OF THE SENSOR PAD
The life span of the sensor pad is set at 2 years, after which the pad must
be replaced.
During maintenance, protect the pad, supply cable and connectors
from mechanical damage and moisture entering.

MXA51005
55
EN
8. ALARM STATES
PHYSIOLOGICAL ALARMS
Alarm state Priority Light indication Acoustic indication
Low breathing rate
Number of inhalations/ex-
halations less than 8/min.
(evaluated in active mode)
High
Red LEDs flash in a circle around
the mechanical button
(2.5 Hz, 200 light/200 ms pause)
Alarm - continuous
melody 80 dB/m +/- 5%
Respiratory arrest
No respiration for more than
17 secs
(evaluated in active mode)
High
Red LEDs flash in a circle around
the mechanical button
(2.5 Hz, 200 ms light/200 ms
pause)
Respiratory arrest
pre-alarm
7 short tones (200 ms
on/200 ms off) after 17
secs of not detecting bre-
athing), then alarm after
3 secs from the start of
the pre-alarm - continuous
melody 80 dB/m +/- 5%
TECHNICAL ALARMS
Alarm state Priority Light indication Acoustic indication
Sensor pad disconnected
Loss of communication with
the pad
(evaluated in active mode)
Moderate
Orange colour flashes in a circle
around the mechanical button
(5 Hz, 100 ms light/100 ms
pause)
Technical alarm - high
intensity intermittent tone
(100 ms tone/100 ms
pause)
Mechanical switch jam
detected in active mode
(evaluated in active mode) Moderate
Orange colour flashes in a circle
around the mechanical button
(5 Hz, 100 ms light/100 ms pause)
and at the same time the indicator
light with the power-on symbol
flashes orange
(5 Hz, 100 ms light/100 ms pause)
.
Technical alarm - high
intensity intermittent tone
(100 ms tone/100 ms
pause)
Reset caused by a watchdog
that monitors the technical
state of the device
(evaluated after switching on
the unit)
Moderate
Orange colour flashes in a circle
around the mechanical button
(5 Hz, 100 ms light/100 ms pause)
Technical alarm - high
intensity intermittent tone
(100 ms tone/100 ms
pause)
Operator’s response to alarm states
High priority: The need for immediate operator response | Moderate priority: The need for rapid operator response

56
MXA51005
EN | Baby breathing monitor
9. OPERATOR WARNING
Event Light indication Acoustic indication
Low battery
The indicator light with the battery symbol
flashes slowly and red
(100 ms light/2 s pause).
No acoustic signal
Critically low battery The indicator light with the battery symbol flashes quickly and red
(100 ms light/300 ms pause) No acoustic signal
Detecting a child placed on the pad
(evaluated in standby mode)
The indicator light with the power-on
symbol flashes orange (1 Hz, 500 ms
light/500 ms pause)
1x beep - warning after 30 secs
from child presence detection, if the
child is still detected (1 sec tone)
Detecting a child removed from the
pad (evaluated in active mode)
The indicator light with the power-on
symbol flashes orange
(5 Hz, 100 ms light/100 ms pause) (Ends
when breathing detected, but 30 times
at most.)
3 notification beeps (300 ms
tone/300 ms pause)
(ends when breathing detected, but
3 times at most)
Low temperature indication
(evaluated in active mode)
The indicator light with the thermometer
symbol flashes blue
(100 ms light/2 secs pause).
(Lasts until the low temperature is no
longer detected.)
No acoustic signal
High temperature indication
(evaluated in active mode)
The indicator light with the thermometer
symbol flashes orange
(100 ms light/2 secs pause).
(Lasts until the high temperature is no
longer detected.)
No acoustic signal
Indication that the sensor pad is
disconnected in standby mode
(evaluated in standby mode)
3x red flashes in a circle around the
mechanical switch
(100 ms light/100 ms pause)
1x beep - warning (500 ms tone)
Mechanical button jam detected in
standby mode (evaluated in standby
mode)
Light with the orange power-on symbol
constantly lit. Releasing the button stops
the light.
No acoustic signal
Error indication and warnings after
automatic functionality test
(evaluated and indicated when swit-
ching to active mode)
Critical error detected - Red LEDs flash in a
circle around the mechanical button
Warning detected - no light indication.
Acoustic indication according
to the type of error or warning
Indication to enable/disable light
functionality
3x flashes of the lamp
(300 ms light/300 ms pause) No acoustic signal
Indication of the Switch Guard
function being disabled
3x orange flashes of the indicator
light with the power-on symbol
(500 ms light/500 ms pause)
2x notification beeps
(1 sec tone, 1 sec pause)
Indication of the Switch Guard
function being enabled
2x orange flashes of the indicator light
with the power-on symbol
(1 sec light/1 sec pause).
1x notification beep (3 sec tone)
Indication of unsuccessful light
activation or light forcibly turned off
due to low/critically low batteries
5 x flashes of the indicator light with the
battery symbol in red (100 ms light/100
ms pause)
No acoustic signal

MXA51005
57
EN
10. IMPORTANT WARNING
Use in an incubator
The Nanny Breathing Monitor can also be used in an incubator.
Only the sensor pad can be placed in an oxygen-enriched
environment, the control unit must always be located outside.
Prior to use, make sure that the incubator does not cause
vibrations that could lead to false detection of the child’s
movement.
Monitoring twins
When using the Nanny BM-03 breathing monitor for twins, the
basic condition is that each child must have its own cot,
in which a separate breathing monitor is installed. Therefore,
the same control unit cannot be connected to 2 sensor pads.
For the device to work properly and evaluate the impulses, the
cots must not be touching each other.
Age of the baby
Use of the Nanny Breathing Monitor is not determined by the
child’s age, but by its weight. The manufacturer recommends
a Nanny breathing monitor for children from a min. weight of 1
kg and a max. weight of up to 15 kg. A heavier child may cause
mechanical damage to the sensor.
Correctly placing the
control unit
The acoustic indicator of the monitor’s control unit must not
face the child and must be placed at least 0.5 meters away
from the child’s head to prevent possible damage to its hearing.
Correct placement
of the cot
The device uses a very sensitive sensor to sense breathing. Its
operation may be affected by shocks to the cot, the floor or even
the building. The cot must therefore not touch a bed, in which
another person is sleeping, nor must it touch or be in the vicinity
of any devices that vibrate.
Use in a pram or cradle
We do not recommend this use! A pram or cradle can move
spontaneously, which can lead to “false movements” being
detected. It is only possible to use the breathing monitor in
places where the sleeping area is fixed and does not touch
anything.
Using another sensor pad
This medical device is not intended to be used with other me-
dical devices. The monitor will not turn on if a different type of
sensor pad or one from a different manufacturer is
connected to it. Likewise, the BM-03D sensor pad cannot be
used in combination with another type of monitor from another
manufacturer.
Mattresses
Most commonly available mattresses can be used with the
breathing monitor. The mattress should be 12 cm thick at most.
It is not recommended to use mattresses made of too hard a
material (polystyrene foam, etc.), which can more easily absorb
interfering shocks from the surrounding air moving.

58
MXA51005
EN | Baby breathing monitor
Modifying the breathing
monitor
Do not open or modify the monitor. Otherwise, the manufacturer
cannot guarantee the correct functionality and usability of the
monitor and assumes no responsibility.
Mechanical damage
to the device
Do not use the monitor in case of mechanical damage, such as
breakage of a large part of the device’s plastic cover - this could
cause excessive release of light or sound, which could harm your
child. If the indicator symbols are no longer legible, for example
due to careless or incorrect cleaning, only use the device if you
can correctly distinguish the light indications of the symbols ,
or ensure that the symbols are marked in an alternative way
(sticker or special marker pen). Otherwise, send the device for
service.
Wireless technology
in range
Please use wireless communication devices, such as wireless
home networks, mobile phones, cordless phones, and their base
stations, portable stations, which may affect the proper operation
of the monitor, at a distance of at least 1 m from any part of the
monitor.
Amateur radio
equipment in range
Amateur radio transmitters and their antennas should be at
least 10 m away. However, the manufacturer cannot guarantee
the proper functioning of the monitor during radio operation
due to the various types of equipment, transmission powers and
antenna systems.
Baby supervision -
help within reach
Please note that the device can only alert you, but it does not of
itself prevent the risk of respiratory arrest! If the child has a
health problem, it is up to you or the doctor to help it. Likewise,
do not move too far away from your child so you cannot hear
and be able to respond to an alarm. Do not use the monitor
in an environment where you may not hear or see the alarm (an
environment that is too noisy or too bright). Supervision must
be carried out only by sighted and hearing persons who are able
to correctly distinguish the alarm and help the child.
Guarantee
The manufacturer is responsible for the functionality of the
BM-03 product if it is installed and used according to this ma-
nual and its recommendations, otherwise it does not bear any
responsibility. The manufacturer is not responsible for the
proper functioning of the product if it has suffered mechanical
or other damage or if the product’s life span has been excee-
ded. The manufacturer is not responsible for battery defects.
A used or borrowed
breathing monitor
The manufacturer strongly discourages buying this product
used or getting it from a hire company. If it is handled
incorrectly, the sensing device’s sensitivity may be reduced
leading to, among other things, an increase in false alarms.
In these cases, the manufacturer is not responsible for the
product’s functionality.

MXA51005
59
EN
False alarms - the monitor
sounds an alarm although the
child is breathing regularly
1) Whilst breathing the child’s movement did not
reliably reach the sensor pad.
• For very small babies, the sensor pad can be placed directly
under the sheet (but always use an insulating pad to prevent
liquids leaking into the pad). Placing it here minimizes the
likelihood of false alarms. When the baby starts to move in the
cot, place the sensor pad under the mattress. If the baby lies in
an inclined position (if it should have its head raised as part of
a doctor’s recommendation), there should be good mechanical
contact between the baby, the mattress and the sensor pad.
Prop up the cot base (not just the mattress) to meet this condi-
tion. Or prop up the back legs of the cot.
• Check that the mattress really lies with its entire weight upon
the sensor pad. The mattress must not be clamped tightly
against the walls of the cot so that it does not “float” above the
cot’s base.
2) The sensor pad does not sense the baby’s breathing
properly - the sensor in the pad is probably mechanically
damaged (for example due to a fall) or the pad’s life span has
expired (2 years) - the sensor pad needs to be replaced.
There was no alarm after ta-
king the baby out of the cot
The sensor pad detects disturbance in the surroundings that
need to be removed. Follow section 4.
After switching on, the device
indicates empty batteries
Make sure you have not used rechargeable batteries (they have
a lower voltage and the device evaluates the situation as low
batteries). Only alkaline batteries can be used.
The lamp does not light
The lamp is deactivated at the factory - follow section 2.2.2.
to activate it. The lamp is also deactivated when the batteries
are low. If you want to continue using it, replace the batteries.
11. PROBLEMS AND HOW TO SOLVE THEM
I placed the child on the pad
in standby mode, but the
unit does not signal the child
being placed on the pad
This is correct behavior of the monitor. The monitor is
equipped with an intelligent evaluation of the stimulation
on the pad, which constantly monitors the environment and
tries to distinguish the probable movements of the child on
the pad from the surrounding stimulation. It is also equipped
with a timer, which repeats the signaling of the laying of the
baby only if no signal has been detected for a certain time
(10 s) since the previous signaling. Therefore, the monitor will
evaluate that the child may have actually been placed on the
pad, and only then will it alert you of the possible need to switch
the monitor to standby mode. Also check that you have not
deactivated the Switch Guard function (see chapter 2.2.1) - this
would be signaled by a 2x warning beep after switching on
the unit during the automatic functionality test.

60
MXA51005
EN | Baby breathing monitor
Power supply 3 V; 2 × 1.5 V alkaline battery type AA (LR6)
Idle consumption 106 µA
Consumption during an alarm 270 mA
Low battery indicator voltage 2.46 V ± 0.15 V
Critically low battery indicator voltage 2.2 V ± 0.15 V
Threshold breathing rate < 8 breaths/min (i.e. < 0.13 Hz)
Measuring range for room temperature -40° to 85°C with an accuracy of ± 0.2°C
Typical battery life - home health care 6 months (this is reduced with frequent alarm testing and using
the lamp)
Typical battery life - health care provider 4 months (this is reduced with frequent alarm testing and using
the lamp)
Sensor pad Type BM-03D, dimensions max. 300 × 500 × 15 mm
Acoustic alarm level 80 dB/m ±5 % dB/m
Electronic control unit - dimensions max. 140×82×37 mm, weight 125 g + batteries
Operating conditions +5 °C to +40 °C, RH 15 % - 93 %, 700–1200 kPa
Transport and storage 0 °C to +70 °C, RH 10 % - 85 %, 700–1200 kPa
Ingress protection IP31
Life span of the sensor pad 2 years from putting into service
Service life of the control unit 10 years
Service life of the device 10 years under the condition of replacing the sensor pad after its
life span (i.e. every 2 years)
Meets the following standards:
EN 60601-1:2006/A1:2012/Cor.1:2014
EN 60601-1-2:2015
EN 60601-1-6:2010/A1:2015
EN 60601-1-11:2015
EN 62366-1:2015; EN 50581:2012
EN ISO 10993-1:2009/AC:2010
EN ISO 14155:2011; EN 14971:2019
EN 14485:2003
13. DEFINITIONS AND SYMBOLS
12. TECHNICAL SPECIFICATIONS
ME device Medical electrical device (with attachment that detects energy from the patient)
EMC Electromagnetic compatibility (a set of normative requirements for a ME device)
SIDS Sudden infant death syndrome
Designation of the attachment part type BF
General sign for compulsory activity
General warning
Refer to the operating manual
IP31 The device’s immunity to the ingress of foreign bodies and water (Ingress protection class)
Product identifi cation by barcode
Prefi x: 0xxxy product identifi cation (02594 unit; 02593 pad): Suffi x: nnnnnnnn serial number
0xxxxynnnnnnnn

MXA51005
61
EN
Certifi cation performed by the notifi ed body EZU Prague No. 1014.
The product has been clinically evaluated and is registered by
the Ministry of Health of the Czech Republic as a medical device class IIb.
JABLOTRON ALARMS a.s. declares that the product BM-03 is designed and
manufactured in accordance with the harmonization legislation of the European Union:
Directive No. 93/42/ECC, as last amended, when used as intended. The original
Declaration of Conformity is at www.monitornanny.com
After use, the battery should not be thrown into the bin, but returned to a collection
point. Although it is free of any harmful materials, do not dispose of it in normal waste,
but in special containers or collection points for the disposal of small electrical
equipment, or hand it over to the dealer or directly to the manufacturer.
PRODUCTION, DISTRIBUTION AND SERVICE:
JABLOTRON ALARMS a.s.
Pod Skalkou 4567/33, 466 01, Jablonec nad Nisou, Czech Republic
www.monitornanny.com | [e-mail]
14. EMC OF A MEDICAL DEVICE
14.1 EMISSIONS LIMITS BY ENVIRONMENT
Phenomenon Professional medical facilities a) Home health care a)
RF emissions propagated by conduction
and radiation CISPR 11 CISPR 11 c) d)
Harmonic distortion see IEC 61000-3-2 b) see IEC 61000-3-2
Voltage fl uctuations and fl icker see IEC 61000-3-3 b) see IEC 61000-3-3
a) For information on the intended use environment.
b) his test is not applicable in this environment if the ME devices and ME systems used are connected to the
public power supply network and the power supply is otherwise within the scope of the basic EMC
standard.
c) ME instruments and ME systems intended for use in aircraft must meet the requirements of RF EMISSI )
ONS pursuant to ISO 7137. The conducted RF EMISSION test is only performed for ME instruments and
ME systems that are intended for connection to an aircraft’s on-board network. ISO 7137 is identical to
RTCA DO-160: 1989 and EUROCARD ED-14C: 1989. The latest editions are RTCA DO-160G:2010 and
EROCAE ED-14G:2011. Therefore, section 21 (category M) of a newer edition, such as [39] or [40], should
be used.
d) Standards applied for other modes or the EM transport environments for which they apply. Examples of
standards that could apply are CISPR 25 and ISO 7637-2.

62
MXA51005
EN | Baby breathing monitor
14.2 IMMUNITY REQUIREMENTS - INPUT AND OUTPUT THROUGH THE DEVICE’S COVER
a) If an interface is used between the simulation of the patient‘s physiological signal and the ME device or ME system, it must be
located within 0.1 m of the vertical plane of the homogeneous field area in one direction with the ME device or ME system.
b) An ME device or ME system that intentionally receives RF electromagnetic energy for its operation must be tested at the
reception frequency. Testing may be performed at other modulation frequencies determined in the risk management
process. This test assesses the basic safety and necessary functionality of the intended receiver when the ambient signal is in
the passband. It is understood that the receiver may not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies determined in the risk management process.
d) Valid only for ME devices and ME systems with magnetically sensitive components or circuits.
e) During the test, the ME instrument or ME system may be supplied with any nominal input voltage, but at the same frequency
as the test signal.
f) Before using modulation.
g) This test level assumes a minimum distance of at least 15 cm between the ME device or ME system and the source of the
mains frequency magnetic field. If the risk analysis shows that the ME instrument or ME system will be used closer
than 15 cm from the source of the mains frequency magnetic field, the immunity test level must be set as is appropriate
for the minimum expected distance.
Phenomenon Basic standard for EMC or
test method
Immunity test levels
Professional medical
facilities Home health care
Electrostatic discharge IEC 61000-4-2 ±8 kV or contact charge
±2 kV, ±4 kV, ±8 kV, ± 15 kV for air discharge
RF EM fields propagated by
radiation a) IEC 61000-4-3
3 V/m f)
80 MHz – 2.7 GHz b)
80% AM at 1 kHz c)
10 V/m f)
80 MHz – 2.7 GHz b)
80% AM at 1 kHz c)
Near fields from RF wireless
communication devices IEC 61000-4-3 see 8.10.
Magnetic field of specified
mains frequencies d) e) IEC 61000-4-8 30 A/m g)
50Hz or 60 Hz