Schulte Elektronik siss babycontrol User manual

®
BABYCONTROL
®
SCHULTE-ELEKTRONIK GMBH
MEDICAL TECHNOLOGY
User instructions

Control elements
2
Control elements
Fig. 1: Control elements

Control elements
3
1
Switch for respiration alarm delay
2 Alarm signal: respiration
3 Function signal: respiration (green)
4 Respiration sensor fault (yellow)
5 Alarm signal: battery discharged
6 ON button / to switch on BABYCONTROL
7
Reset button for Alarm
8 Button for respiration monitoring tone: On/Off
9 Battery compartment (back of monitor)

Key to Symbols
4
Key to Symbols
Respiration monitoring
Respiration monitoring tone ON / OFF
Body sensor
Malfunction
ON button
Switches off the instrument (press buttons 6 and 7
simultaneously - this serves as child protection)
Reset alarm button
Monitor Connections
Fig. 2: Monitor connections
10 Alarm output
11 Socket for body sensor

Contents
5
Contents
Control elements.......................................................................... 2
Key to Symbols............................................................................ 4
Monitor Connections .................................................................... 4
Contents ..................................................................................... 5
Purpose and Function .................................................................. 6
Notes Concerning these Instructions ............................................. 7
Important Notes ........................................................................... 8
Safety Notes................................................................................ 9
Brief Instructions: First Use ........................................................ 10
Applying the respiration sensor ................................................... 10
Overview of Alarm and Fault Indications .................................... 11
Installing and switching on the monitor ........................................ 13
Respiration monitoring ............................................................... 14
Memory Function ....................................................................... 16
Action in the event of an alarm.................................................... 17
Monitor behavior during alarm..................................................... 18
Care and maintenance of the monitor .......................................... 19
Messages, faults and troubleshooting .......................................... 21
Reading out the data with a PC................................................... 23
Technical Data .......................................................................... 25
Maintenance and calibration ....................................................... 27
Technical description ................................................................. 28
Warranty ................................................................................... 35
Liability ..................................................................................... 36

Purpose and Function
6
Purpose and Function
Dear Customer,
With SISS BABYCONTROL, you have purchased an
easy-to-use device for monitoring the respiration in babies and
infants.
SISS BABYCONTROL issues an Alarm as soon as a dangerously
long interruption to respiration occurs.
SISS BABYCONTROL saves all processes automatically
with an accuracy of seconds. Specific operating procedures for
this purpose are not necessary. The processes saved include:
on and off switching of the instrument,
resetting of the alarms,
all types of alarms,
respiration rate by alarm
The optionally available USB adapter with software allows the events
recorded to be displayed and evaluated on a commercially
available PC.
The SISS BABYCONTROL is suitable for monitoring the respiration
of babies and infants in a mobile and domestic environment, as well
as in hospitals and similar establishments.

Notes Concerning these Instructions
7
Notes Concerning these Instructions
Warning, noncompliance with which can
endanger the child.
Special notes, tips
G R O S S Indicates a button on the instrument
Courier Indicates a software menu item
Fett Particular highlighting in the text
=> Refer to…

Important Notes
8
Important Notes
Warning:
Noncompliance with the User Instructions can
result in malfunctions or less effective monitoring,
and this in turn can result in injury or death of the
child.
Warning:
The SISS BABYCONTROL monitor can be of
assistance only if the person caring for the child is
always within the audible range of any possible
alarm. Only by this means can vital assistance be
given in the event of en emergency.
Also the supervisory person must convince the
undisturbed operation of the monitor.
Thus the proper functions of the buzzer (alarm tone
/ soft clicking tone) and the announcement
elements (puls-LED's) are to be controlled with
every turning on and in the running operation
regularly.
Before putting your SISS BABYCONTROL monitor into
operation, please comply with the following instructions:
These User Instructions must be carefully studied by all persons
looking after your child. This will avoid errors in operation and
misunderstandings. These User Instructions form part of the
SISS BABYCONTROL monitor and must always be kept in its vicinity.

Safety Notes
9
Safety Notes
1. The monitor is not defibrillation-proof.
Disconnect the monitor from the patient before
using a defibrillator.
2. The monitor is not designated for explosion-
endangered areas.
3. Mobile communication devices (e.g. radio
telephones, radio equipment) must not be used
within a 1 m distance of the monitor (look at the
technical description at page 28). These devices
can disrupt or render impossible the safe
functioning of the SISS BABYCONTROL monitor.
4. Do not leave small parts (packaging materials
etc.) in your child's bed. He/she could swallow
them.
5. For safe operation of the monitors, please use
only the batteries/rechargeable batteries
recommended and the recommended charging
method.
=>Battery and rechargeable battery supply /
Battery changing /Battery alarm Page 19

Brief Instructions: First Use
10
Brief Instructions: First Use
The following notes on first use will help you to quickly get used to
operating the monitor.
1. Apply the blue respiration sensor as in Fig. 3. Secure the
respiration sensor to the child’s body with the Leukosilk or
Leukopor sticking plaster supplied. One horizontal strip across the
sensor will suffice. The respiration sensor must not be kinked.
2. Connect the respiration sensor to the 3-pole socket of the monitor.
3. Check the alarm limit set on the monitor.
4. Switch on the monitor by pressing the button ( 6 ) and keeping
it pressed for about 1 second.
5. The monitor then carries out a self-test and, after emitting an
acknowledge tone, starts reliable monitoring.
Applying the respiration sensor
Fig. 3: Recommended location of the respiration sensor

Overview of Alarm and Fault Indications
11
Overview of Alarm and Fault Indications
Significance of the LED colors
Green: Activity display of the respiration function
Red: Patient alarm: the permitted pause in respiration
has been exceeded
Yellow: - Technical alarm: sensor error
- Battery alarm
Patient alarms are high-priority alarms.
They indicate a situation requiring immediate
attention to your child.
This includes the respiration alarm. It indicates that
the permitted pause in respiration has been
exceeded. The alarm is indicated by the red LED (2).
In addition, the sequence of tones for the patient
alarm is emitted repeatedly:
‘ Beep - Beep - Beep- short interval - Beep - Beep
– long interval ‘
=>Monitor behavior during patient alarm Page 17
Technical alarms are medium-priority alarms
These indicate a longer lasting fault or malfunction of
the monitoring channel, e.g. a defective or
disconnected respiration sensor.
Correct monitoring cannot be continued.
The alarm is indicated by the yellow LED (4).
In addition, the sequence of tones for the medium-
priority technical alarm is emitted repeatedly:
‘ Beep – Beep – Beep – long interval – Beep – Beep
–Beep – long interval ‘
=>Monitor behavior during medium-priority technical
alarms Page 18

Overview of Alarm and Fault Indications
12
Battery warning
The yellow LED ( 5 ) lights up every 10 sec.
Monitoring will continue but the battery /
rechargeable battery should be exchanged as soon
as possible.
=> Battery and rechargeable battery disposal / battery
changing / battery alarm Page 19
Battery alarm
Indicated by the lighting of the yellow LED ( 5 ) with
the sequence of tones for the medium-priority
technical alarm emitted.
Monitoring is no longer carried out. Exchange the
battery / rechargeable battery immediately to
continue monitoring.
=> Battery and rechargeable battery disposal / battery
changing / battery alarm Page 19

Installing and switching on the monitor
13
Installing and switching on the monitor
Place the monitor in a position where the displays are easily visible
on entering the room. With the optionally available multifunction case
the SISS BABYCONTROL is optimally protected.
Warning:
Do not place the SISS BABYCONTROL directly
over the bed. Otherwise the monitor could fall into
the bed and injure your child if the cable is pulled.
Before switching on the SISS BABYCONTROL, first apply the
respiration sensor to your child.
=> Brief Instructions: First Use Page 10
It is best to lead out the sensor cable at the foot end of the bed, so
that your child will not use it as a toy.
Switch on the monitor with the ON button (6).
Warning:
Before switching on, check that the rotary switch is set
correctly for the alarm value to be monitored .
As soon as it is switched on, the monitor carries out a self-test: all
monitoring LED’s light up in turn. A short signal tone also sounds at
the beginning and end of the test.
This allows you to check the LED’s and the audible signal generator
for correct function each time you switch on the monitor.
The flashing green monitoring LED (3) together
with a soft clicking tone on the SISS
BABYCONTROL indicate regular respiration. You
can enable/disable the monitoring tone by pressing
the “Respiration monitoring tone” button (8) .

Respiration monitoring
14
Respiration monitoring
Respiration sensing
Respiration movements (diaphragm movements) are transformed into
electrical signals by the piezo-element in the respiration sensor via
compression / bending moments. The sensor sensitivity is largely
determined by its location (next to the navel) and the strength of the
diaphragm movement prevailing in that position.
In special cases of shallow breathing, the respiration sensing on the
monitor can be switched to a more sensitive setting:
Fig.4: Sensitivity switch of the respiration channel
in the battery compartment.
Position N: Normal
Position E: Sensitive
=> Messages, Faults and Troubleshooting Page 21
Alarm delay
Babies occasionally experience interruptions in respiration of more
than 10 seconds. This is not unusual. These irregularities in the
respiratory rhythm decline with increasing age and, in most cases,
they have disappeared by three years of age. If, however, the
respiratory arrest exceeds the above-specified period and/or occurs
more frequently, then your baby may be at risk. To compensate for
individual fluctuations, the delay time after which the alarm is
given can be adjusted.
Setting the respiration alarm time
Attention: Alter the limit values only when the monitor is switched off.
Changes to the limit values become effective only when the monitor
is switched on again (child safeguard).

Respiration monitoring
15
Adjustments are made with the rotary switch (1). Set the limit value
as directed by your doctor. A time of 20 seconds (for babies) or 15
seconds (from about the second month of life onwards) is often used. If
alarms often occur without there being an actual danger situation,
the alarm time can be increased after consultation with the attending
pediatrician (20 or 25 seconds).
Respiration alarm
The alarm is triggered as soon as no pulse from the respiration
sensor has been detected over the duration of the set respiration
alarm time. The red LED (2) lights and the sequence of tones is
emitted for the patient alarm.
No respiration, emergency situation!
See the details on Page 17 “Action in the event of
an alarm”.
Central and obstructive apneas
SISS BABYCONTROL can wrongly interpret
vibration-induced movements as respiration, e.g.
during transport by ambulance, car or
perambulator. The same applies when the child is
held in your arms. Central apneas (no respiration
or activity of the respiratory muscles) can therefore
be detected only under the proviso that the child is
sleeping, lying quietly, not moving or being moved.
Obstructive apneas, i.e. apneas caused by
occlusion or blockage of the respiratory passages
are not detected by the SISS BABYCONTROL.

Memory Function
16
Memory Function
The memory function is always enabled. No special operating
procedures are required for this function.
The memory is a ‘non-volatile ring memory’, i.e. the stored data are
not lost if the battery is removed. When the memory capacity is
exceeded, the oldest data are overwritten.
However, the battery should remain in the monitor, otherwise the
date and time information in the software will not be correctly
indicated. The internal clock is buffered for short time removal
(approx. 1-2 days) or battery changing.

Action in the event of an alarm
17
Action in the event of an alarm
What to do in the event of a patient alarm
The following information represents only a very short summary
of the measures which must be taken in the event of an emergency:
1. Switch off the alarm by pressing the RESET button .
2. Check for breathing:
Notice if the baby’s colour is paler than normal or blue.
Place your cheek next to the baby’s face to see whether you
can feel or hear any breathing.
Look down for movement of the baby’s chest and tummy.
Stimulate the baby by talking, tickling the soles of the feet or
picking the baby up.
3. If the baby is not breathing carry out the resuscitation
techniques that you have learned and immediately seek medical
assistance
Warning:
Specifically, the actions taken in Point 2 can be
taught only by a trained person. Also knowledge of
resuscitation measures for adults is not sufficient,
since with children there are a number of specific
differences involved.

Monitor behavior during alarm
18
Monitor behavior during alarm
Monitor behavior during patient alarm
Alarm indication: => Overview of alarm and fault indications Page 11
Reset the patient alarm by pressing the button :
The alarm tone stops and the alarm LED (2) goes out.
No further respiration alarm will be given for the next 30 secs.
(alarm suppressed).
The green respiration indication LED (3) remains activated.
If, after the alarm suppression time, the alarm condition persists, an
alarm is triggered again.
Monitor behavior during medium-priority technical alarms
Alarm indication: => Overview of alarm and fault indications Page 11
Reset a medium-priority technical alarm by switching off the monitor
(press buttons and ).

Care and maintenance of the monitor
19
Care and maintenance of the monitor
Monitor test
Switch on the monitor once a week with the respiration sensor
plugged in but without applying the sensor to your child.
Ensure that the sensor lies completely undisturbed.
1. After the set time, the respiration alarm must occur (red LED
(2)) followed by the high-priority alarm tone.
2. Remove the respiration sensor. The fault display should now
light up (yellow LED (4)).
The tone will change to the medium-priority alarm tone.
=> Overview of alarm and fault indications Page 11
Cleaning Instructions for the device and Reusable Sensor.
Warning:
Do not autoclave or immerse the device or sensor in liquid.
Device:
Clean the surface of the device with a soft cloth moistened with
water or a mild soap solution. If disinfecting is necessary, wipe the
surfaces of the device with isopropyl alcohol (eg. Clinell
solution/wipes) Then wipe over with a soft water-moistened cloth.
Do not allow any liquid to enter any of the devices openings.
Sensor:
Disinfecting the resuable sensor – wipe/spray the sensor with
isopropyl alcohol following the disinfectant manufacturers guidleines
for relevant disinfection timescales. Then, wipe over with a soft
water-moistened cloth prior to use.

Care and maintenance of the monitor
20
Battery and rechargeable battery disposal / battery changing / battery alarm
With average use, the life of a battery will be approximately 6 to 8
weeks.
Before the actual battery alarm, the monitor will give a battery
warning: the yellow LED will flash every 10 seconds during
operation.
The battery should then be changed within the next 1-2 days.
A rechargeable battery should be changed immediately.
You can suppress the flashing for a short time
with the button .
When the battery voltage drops further during operation, the actual
battery alarm occurs. A medium-priority tone sounds and the yellow
display “Battery alarm” (5) lights up.
To change the battery, open the battery compartment and insert the
new battery in accordance with the label in the battery compartment.
Note:
Discharged batteries which are not removed from
the monitor can damage the monitor by leaking
acid.
When discharged, take the batteries to the correct
special waste disposal or your dealer's collection
point. Do not throw them in your domestic waste!
The following batteries / rechargeable batteries are urgently
recommended to ensure safe operation of monitors:
Batteries: 9 V block battery, alkaline type,
e.g. Duracell Plus
Rechargeable batteries
9 V block rechargeable battery, 200 mAh
NiMH
e.g. ANSMANN 9V Block PP3 6F22
Using rechargeable batteries:
Avoid unnecessary battery alarms by changing rechargeable
batteries regularly and promptly. Always keep a charged-up
rechargeable battery ready.
Batteries/rechargeable batteries differing from the types listed above
can lead to operating faults in the event of a weak charge.