SISS BABYCONTROL Service Manual Ver 1.01 Oct 2012

Service Information SISS BABYCONTROL® and SISS BABYCONTROL plus® Notes on regular servicing SISS BABYCONTROL SISS BABYCONTROL plus Monitors are not subject to regular annual testing according to MPG regulations. However, the manufacturer recommends: - Function testing of monitors and accessories on change of patient (preliminary service) - Every 3 calendar years: testing of monitors with any updates of the internal software (full service) If required, the manufacturer can also supply circuit diagrams, spare parts lists, descriptions, calibration aids and setting instructions in respect of the monitors listed, to be used by appropriately qualified employees of the user for equipment repairs. However, the manufacturer is not responsible for repairs, modifications, adjustments or similar interventions when these are undertaken by employees of the user or agent. This also applies when the equipment is designated by the manufacturer as “Repairable by the customer” and suitable documents are available. After such interventions, the warranty provisions also no longer apply. Costs: Where servicing is carried out by the manufacturer, the details given in the currently valid price list apply. Manufacturer: SCHULTE-ELEKTRONIK GMBH Schörenbergstr. 20 59939 Olsberg Germany

Additional checks at every change of patient: Visual inspection of sensor plug: In case of heavy wear and tear is a replacement needed Foam pad available behind the battery contacts?

Check the correct fitting oft he battery Turn the contacts

Check rotary switch: Engages the rotary switch to the 4 positions. Determines the position of the arrow in line with the display on the keyboard

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 resp iration 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 ). The tone will change to the medium -priority alarm tone.

Details of SISS BABYCONTROL plus General What is the power consumption of the SISS BABYCONTROL plus? The power consumption is extremely low. When it is switched off, its consumption is only 7 µA, and when switched on only 400 µA. It has a correspondingly long battery life. Why is the metal plug screened? The screening prevents static charges on the sensor input. How is the technical alarm detected? A short measurement by means of a patient control current is used to check that the cable connection is correct and that the electrodes are correctly applied. The control current is only 15 µA at 5 V. This measurement takes place after 32 s. Further measurements take place at 15 min. intervals and before the issue of an alarm when an alarm occurs. What must be done in the event of an technical alarm? In all cases, the technical alarm must be cancelled by switching off the power. The cause of the fault must first be remedied before the monitor can continue to be used.

Breathing What are the alarm criteria? Basically, an alarm is triggered when no further signals appear within the set time after the last respiration pulse. In addition, an alarm is given when the pauses in respiration have been longer than 90 % of the set value four times in succession. What is the difference between the two sensitivity stages? There is a slide switch in the battery compartment with the settings N = Normal and E = Sensitive. In particular, in the case of premature babies or babies up to the 4 th week, respiration may be so slight that repeated apnoea alarms (false alarms) occur. Setting E can reduce or stop this. The switch should be reset to N again not later than the 4th week.

Heart How is the heart rate ascertained? The heart rate is ascertained by detection of the QRS complex. This takes into account both the positive and the negative components of this complex. This results in very safe detection. What are the alarm criteria? The heart rate is calculated by counting the heart beats within 6 sec. and calculating the minute value. An alarm is triggered when the heart rate is above or below the set value. When is it necessary to use the third electrode? The third electrode may be necessary if bradycardia or tachycardia alarms occur which cannot be explained. The third electrode can improve the heart signal reception.

Only for internal information for medical product advisers of SCHULTE-ELEKTRONIK GMBH Copying and written communication to third parties prohibited.

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Frequent Questions On the technology of SISS BABYCONTROL plus Does the SISS BABYCONTROL plus have a power pack? No. The SISS BABYCONTROL plus is operated with just one battery ( 9 V). 9V rechargeable batteries can also be used. These must be changed approximately once a week. How long does a battery last? Alkaline batteries are recommended wherever possible. These last about 2 months. Special 9 V lithium batteries can double this operating time. Must the battery be removed when not in use? No. Consumption is only about 7 µA. The battery should remain fitted to power the internal clock. When it is changed, the battery can be removed for up to 2 days without problem. How many events will the memory hold? About 1,000 events can be recorded. The current events will then overwrite the oldest. Recommended readout period: every 30 days. Can I recognize when the memory is full? This is not shown. Storage is on the FIFO principle. When the memory is full, the oldest data will be overwritten. When the data is read out, an instruction appears after 75 % memory occupancy telling you to delete the memory. Which data are stored? The SISS BABYCONTROL plus stores all relevant data: ON / OFF, RESET, the rotary switch settings, the type and duration of all alarms which have occurred. In addition, the respiration and heart rates are shown before and after an alarm. How is the SISS BABYCONTROL plus read out? The read-out process is extremely simple and can be carried out even by newcomers to computers: place the SISS BABYCONTROL plus on the read-out pad and start data transfer by pressing the relevant buttons. If read-out has already taken place once, the data are automatically assigned to the patient. Is summer and winter time taken into account? Yes. Summer and winter time is automatically taken into account during the read-out. What evaluation is provided by the software for SISS BABYCONTROL plus? For every alarm, the course of the respiration and heart rates is shown graphically 60 sec. before and after the alarm. The type and duration of the alarm are displayed as well as how the alarm was cancelled. How is respiration monitored? A piezo respiration sensor detects and records the respiration movement without sending a constant measuring current (as with impedance measurement) through the baby’s body. Respiration monitoring with a respiration sensor has been tested for over 10 years and is almost free of false alarms. What must be done in the case of skin irritations (particularly with disposable electrodes)? Two makes of disposable electrodes are approved for the SISS BABYCONTROL plus. Alternatively, permanent electrodes can also be used, if both the makes of disposable electrodes cause skin irritations. Skin contact is not as good as with disposable electrodes – false alarms can occur (technical alarm / bradycardia) Can only the respiration or only the heart be monitored? Yes. Switching over is protected and should only be carried out after consultation with the paediatrician concerned. The changeover requires special instructions from the manufacturer. What accessories can I connect to the SISS BABYCONTROL plus? The following external signalling equipment can be connected: external signal generator, hospital pager (nurse pager) and alarm center. Are there smaller devices than SISS BABYCONTROL plus? No. As far as the manufacturer is aware, the SISS BABYCONTROL plus is the smallest monitor for cardiac and respiration monitoring anywhere in the world.

Only for internal information for medical product advisers of SCHULTE-ELEKTRONIK GMBH Copying and written communication to third parties prohibited.

10829_Häufige Fragen_VK.doc

SISS BABYCONTROL (plus) (temp) Notes on regular servicing SISS BABYCONTROL plus, SISS BABYCONTROL and S BYCONTROL temp Monitors are not subject to regular annual testing according to MPG regulations. However, the manufacturer recommends: - Function testing of monitors and accessories on change of patient (preliminary service) - Every 3 calendar years: testing of monitors with any updates of the internal software (full service) If required, the manufacturer can also supply circuit diagrams, spare parts lists, descriptions, calibration aids and setting instructions in respect of the monitors listed, to be used by appropriately qualified employees of the user for equipment repairs. However, the manufacturer is not responsible for repairs, modifications, adjustments or similar interventions when these are undertaken by employees of the user or agent. This also applies when the equipment is designated by the manufacturer as “Repairable by the customer” and suitable documents are available. After such interventions, the warranty provisions also no longer apply. Costs: Where servicing is carried out by the manufacturer, the details given in the currently valid price list apply.

Olsberg, 22.01.03 Manufacturer: SCHULTE-ELEKTRONIK GMBH Schörenbergstr. 20 59939 Olsberg

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Supplement to User Instructions

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Yours sincerely

SISS BABYCONTROL

®

plus

Limited Use ®

It may be appropriate to use the SISS BABYCONTROL plus either for respiration only or for heart rate only. This may be the case, for example, if the skin is to be protected for a few days because of irritation caused by the disposable electrodes. Limited monitoring should in all cases be approved by the paediatrician concerned. Switching on the instrument without heart monitoring: 1. Start the instrument by simultaneously pressing the “Tone” button ( ) and the “ON” button. 2. Keep the two buttons pressed (about 7 sec.) until the two “Bradycardia” and “Tachycardia” LEDs start to flash simultaneously. Switching on the instrument without respiration monitoring: 1. Start the instrument by simultaneously pressing the RESET and ON buttons. 2. Keep the two buttons pressed (about 7 sec.) until the red ”Apnoea” LED flashes. If you switch on the instrument only with the ON button, monitoring is again activated for respiration and heart for safety reasons.

SCHULTE-ELEKTRONIK GMBH

59939 Olsberg

Tel. 02962 9707 – 0

type of monitor

 BC

serial number date customer

Check list  BCp examiner

customer number

1. Accessories ___ instructions of use ___ battery ___ body sensor Silikon Nr.: _____________ ___ body sensor Silikon Nr.: _____________ ___ patient main cable Nr.: _____________

___ video ___ Leukosilk ___ srew driver ___ elecrodes

2. Checking open the battery compartment, check the battery voltage set the slide switch in the battery compartment to ‘E‘ (sensitive) Bumpers in the battery compartment and battery compartment case okay ? switch the monitor on without boby sensor and electrodes

must be : >= 9,3V switch must be on the left side

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LED’s checking fault indicator: patient main cable/electrodes and body sensor with sound alarm

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connect patient main cable and test equipment (switch on the monitor with the signed limits, wait for alarm, and switch off again) Apnoe checking part switch on the APHX, switch must be to ‘U‘; ckeck on regular pulse switch on the HPI ; switch on the monitor with the limits 10/60/180 APHX switch to ‘u‘ after 10 sec Apnoe alarm APHX switch to ‘U‘, check on regular pulse switch on the monitor with the limits 10/60/180 switch APHX off after 15 sec Apnoe alarm switch on the monitor with the limits 20/60/180 check on regular pulse switch APHX off after 20 sec Apnoe alarm switch on the monitor with the limits 25/60/180 check on regular pulse switch APHX off after 25 sec Apnoe alarm check the TON and RESET button by pressing Heart rate checking part (switch on the monitor with the signed limits, wait for alarm, and switch off again) alarm type BCp phantom alarm always alarm never alarm sometimes - Bradycardy 60 50 O -Bradycardy 70 60 O - Bradycardy 80 70 O - Bradycardy 90 80 O - Tachycardy 180 190 O - Tachycardy 200 210 O - Tachycardy 220 230 O - Tachycardy 240 250 O acoustical and optical alarms every test okay checking electrode impedance fault indicator: patient main cable/electrodes and bradycardy make data reset set the slide switch in the battery compartment to ‘N‘ (normal) switch must be on the right side housing (print, gluing, brief instructions) cleanliness of the monitor default alarm limits 70bpm 200bpm 15s final inspection before distribution, date: name: ready for dispatch

Prüfprotokoll Kunde BC BCp englisch.doc © SCHULTE-ELEKTRONIK GMBH MNSeite 1 von 1

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Rev. 1 vom 24.02.2012

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