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®

BABYCONTROL

®

SCHULTE-ELEKTRONIK GMBH

 

MEDICAL TECHNOLOGY

User instructions

Summary of Contents for siss babycontrol

Page 1: ... BABYCONTROL SCHULTE ELEKTRONIK GMBH MEDICAL TECHNOLOGY User instructions ...

Page 2: ...Control elements 2 Control elements Fig 1 Control elements ...

Page 3: ...gnal 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 ...

Page 4: ...ion 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 ...

Page 5: ...espiration 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 descripti...

Page 6: ...ccuracy 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 mon...

Page 7: ...es 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 ...

Page 8: ...lso 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 Instruct...

Page 9: ...hin 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 ch...

Page 10: ... 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 reli...

Page 11: ...eeded 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 Co...

Page 12: ...tery 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 P...

Page 13: ...ead 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...

Page 14: ...t 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 ...

Page 15: ...espiration 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 he...

Page 16: ...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 ...

Page 17: ... 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 ...

Page 18: ...D 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 ...

Page 19: ...larm 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 wa...

Page 20: ...tment 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...

Page 21: ... Beep Beep Beep Pause Battery alarm Insert a new battery rechargeable battery immediately Yellow battery LED 5 flashes Battery warning Battery rechargeable battery still have a residual charge monitoring is still possible for a short time 1 2 days depending on battery rechargeable battery type You can reset the warning LED by pressing the button You will avoid an unnecessary battery alarm by immed...

Page 22: ...tivity of the respiration detection Note After respiration stabilizes reset the sensitivity to normal sensitivity Respiration sensing Page 14 Frequent unexplained alarms on all channels Disturbance to the monitor due to electromagnetic interference Remove electrical and electronic equipment e g listening device or mobile phones from the immediate vicinity of the monitor Technical description Page ...

Page 23: ...perating system Windows 95 98 NT 2000 XP 1 1 unassigned USB port or serial port COM 1 4 2 MB available hard disk space Program installation 1 Connect the transponder pad to a free USB port or serial port of your computers 2 Insert the CD with the user software into the appropriate computer drive 3 Follow the instructions in the installation program The transponder pad can be permanently connected ...

Page 24: ...der pad and follow the directions Deleting data from the monitor After transfer you can clear the memory in the device by pressing RESET The device switches off automatically If the data are not deleted the device switches off automatically after 2 minutes Evaluating data Click on an event The screen shows additional information relating to the event selected Click on Evaluation to view the statis...

Page 25: ...rechargeable battery 200 mAh NiMH Battery changing Depending on battery type after approx 6 to 8 weeks with the named batteries with rechargeable batteries also less Applied part BF Equipment protection IPX1 Functional data Function displays Respiration signal visual green LED 3 Signals Respiration monitoring audible can be cancelled Respiratory arrest visual red LED 2 audible Battery empty visoua...

Page 26: ... temperature 4 50 C Dimensions L x B x H in mm 152x78x29 Weight Approx 245 g incl battery Regulatory data Classification according to the German Medical Product Act MPG II B CE mark CE 0197 We reserve the right to make any modifications Disposal instructions Dispose of the packaging sorted according to type of material When you want to dispose of the product ensure that this is done according to l...

Page 27: ...ied which will assist the user s qualified staff in carrying out repairs However the manufacturer is not liable for repairs modifications adjustments or similar interventions when these are undertaken by the dealer s or user s technical staff This also applies when these devices are designated by the manufacturer as repairable by the customer and suitable documents are available Also no claims und...

Page 28: ...ry listed above is as far as the function makes possible also practicable with SISS observation monitors of SCHULTE ELEKTRONIK GMBH which will keep to the compliance with the corresponding standard regarding immunity and emission behavior Concerning the USB Transponder Pad an analysis of risk has given that there is no influence on the essential performance criteria of SISS BABYCONTROL monitors Th...

Page 29: ...able Guide and manufacture s declaration electromagnetic immunity The SISS BABYONTROL monitors are intended for use in electromagnetic environment as described below The client or user of The SISS BABYONTROL monitors should make sure that it is used in such an environment Immunity test IEC 60601 1 2 test level compliance level Electromagnetic environment Guide Electro static discharge ESD acc IEC ...

Page 30: ...f c 3 V m 1 5V m c Portable and mobile radio equipment should keep to the recommended protective distance to the BC SPO2 ECG inclusive the lines which is calculated acc that equation that is applicable for the transmitter frequency Recommended protective distance P d 17 1 P d 77 1 80MHz 800 Mhz P d 33 2 0 8GHz 2 5GHz with P as nominal radiated power of the transmitter in Watt W acc to the declarat...

Page 31: ...Hz and 3 0 V m in the frequency range 800 MHz to 2 5 GHz Recommended protective distances between portable and mobile RF telecommunication devices The SISS BABYCONTROL monitors are intended for use in an electromagnetic environment where the HR immunity is controlled The client or user of BC BCp can help to avoid electromagnetic interference by keeping the minimum distance between portable and mob...

Page 32: ...e noted distances the SISS BABYCONTROL monitors should be observed from the beginning to check the regular function In case of doubt the regulation above about the protective distance has to be kept examples device Radio characteristics no interference above a distance of Mobile phone 800 900 1800 MHz 1 2W GMSK 1 0m Wireless telephone DECT 1880 1930 MHz 250mW GPSK 0 7m Wireless telephone CTx 860 9...

Page 33: ...Technical description 33 ...

Page 34: ...Technical description 34 ...

Page 35: ... purchaser who herein already accepts this assignment in such a case in advance If warranty by the supplier is out of the question or if the supplier refuses to provide a warranty in respect of the purchaser our warranty is limited to subsequent compliance i e provision of spare parts or repairs at our option The purchaser shall return the deficient goods or exchanged parts to us If subsequent com...

Page 36: ...s in respect of repaired or exchanged parts II Liability Claims by the purchaser beyond those specified in Clause I no matter on which legal grounds are excluded We do not therefore accept liability for damage or loss not occurring in the delivery item itself and not for other damage to the property of the purchaser The above exemption from liability does not apply to personal injury it does not a...

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