SCHULTE-ELEKTRONIK

SISS Respiration Rate Monitors

SiSS BABYCONTROL User Instructions Sept 2014

User Instructions

34 Pages

File Type: PDF

File Size: 650 KB

File Name: siss_babycontrol_user_instructions_sept_2014.pdf

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Page 1

User Instructions SISS BABYCONTROL

Control elements

Fig. 1: Control elements

Control elements

Switch f or respirat ion alarm delay

Alarm signal: respir ation

Funct ion signal: respiration (green)

Respirat ion senso r f ault ( yellow)

Alarm signal: batter y discharged

ON button / to switch on BABYCONTRO L

Reset button f or Alar m

Button f or respirat ion monitor ing tone: On/Off

Batter y compartment (back of monitor)

Key to Symbols

Key to Symbols Respiration monit oring 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

Socket for body sensor

Contents

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 ..................................................................................... 33 Liability ....................................................................................... 34

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 dom estic environment, as well as in hospitals and similar establishments.

Notes Concerning these Instructions

Warning, noncompliance with which can endanger the child.

Special notes, tips

GROSS

Courier

Fett

Indicates a button on the instrument

Indicates a software menu item Particular highlighting in the text

Refer to…

Important Notes

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 i s 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 b uzzer (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 t he 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 alwa ys be kept in its vicinity.

Safety Notes

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 explosionendangered 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 BABYCON TROL 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

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 it pressed for about 1 second.

( 6 ) and keeping

5. The monitor then carries out a self -test and, after emittin g an acknowledge tone, starts reliable monitoring.

Applying the respiration sensor

Fig. 3: Recommended location of the respiration sensor

Overview of Alarm and Fault Indications

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 repea tedly: ‘ 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

Battery warning The yellow LED ( 5 ) lights up every 10 sec. Monitoring will continue but the ba ttery / 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 L ED ( 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

Installing and switching on the monitor Place the monitor in a position where the displays are easily visible on entering the room. W ith 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 shor t 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

Respiration monitoring Respiration sensing Respiration movements (diaphragm mov ements) 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 pr evailing 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 channe l 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 fluctuat ions, 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

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 t he 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 c aused by occlusion or blockage of the respiratory passages are not detected by the SISS BABYCONTROL.

Memory Function

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 batter y is removed. When the memory capacity is exceeded, the oldest data are overwritten. However, the batter y 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

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 ad ults is not sufficient, since with children there are a number of specific differences involved.

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 a ctivated. 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

Care and maintenance of the monitor Monitor test Switch on the monitor once a week with the respiration sensor plugged in but without a pplying 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 iso propyl 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

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 r emoved 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 / rechargeabl e 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.

Messages, faults and troubleshooting

Messages, faults and troubleshooting Note: The following tables assist in the rapid understanding of messages and for the detection and remedy of possible faults and problems. Please also refer to the information i n the previous sections on the relevant subjects. In case of doubt, contact your dealer or the manufacturer.

Technical faults Fault / Indication Yellow battery LED (5) lights up, tone sequence emitted for medium-priority tech. alarm (Beep – Beep –Beep –Pause ...)

Yellow battery LED (5) flashes

Cause / Remedy Battery alarm. Insert a new battery / rechargeable batter y immediately.

Battery warning. Batter y / rechargeable batter y 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 immediately inserting new battery / rechargeable battery.

Fault / Indication

Cause / Remedy

Medium-priority technical alarm. Yellow LED (4) lights up in addition with tone sequence emitted for medium-priority tech. alarm

Check the connection of the respiration sensor or exchan ge it.

( Beep – Beep - Beep – Pause...)

Messages, faults and troubleshooting

False alarms Alarm (Frequent) unwarranted respiration alarms, particularly with babies aged from 1-4 weeks

Cause / Remedy Shallow breathing. Increase the monitor sensitivity of the respiration detection.

Note: After respiration stabilizes, reset the sensitivity to normal sensitivity => Respiration sensing Page 14 ( Frequent ) unexplained alarms Disturbance to the monitor due to on all channels electromagnetic interference. Remove electrical and electronic equipment e.g. listening device or mobile ‘phones from the immediate vicinity of the monitor => Technical description Page 28

Reading out the data with a PC

Reading out the data with a PC For this you will need the optionally available user software as well as the transponder pad. The transponder pad is available in two versions: -

USB transponder pad (with USB port) Transponder pad (with serial port)

System requirements: -

PC with operating system W indows 95/98/NT/2000/XP

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 to the computer.

1 W i n d o w s u n d W i n d o w s 9 8 / ME / 2 0 0 0 / X P ( h o me ) a r e t y p e d i n T r a d e ma r k o f Mi c r o s o f t c o r p o r a t i o n

Reading out the data with a PC

Reading out the data 1. Start the user software by double clicking on the program icon on the Desktop or via the Start menu. 2. Under “Options / Hardware Settings”, s elect the appropriate interface (USB or RS -232 and COM port). 3. Select data transfer. 4. Place the SISS BABYCONTROL on the transponder pad and follow the directions.

Deleting data from the monitor: After transfer you can clear the memory in the device by p ressing 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 o n "Evaluation" to view the statistics of events. Select "Print" to print out the values displayed. You can store patients in the archive and save their data.

Technical Data

Technical Data Article:

Scope of delivery:

1 1 1 1 1 1

SISS BABYCONTROL respiration sensor User instruction training file on DVD adjustment aid case

Article number B00001 BZ0005

Electrical data

Operating mode: Battery changing:

Battery operation, 9 V monobloc battery type Alkaline or 9 V monobloc rechargeable battery , 200 mAh NiMH Depending on battery type after approx. 6 to 8 weeks with the named batteries, with rechargeable batteries also less.

Applied part:

Equipment protection

IPX1

Functional data Function displays

Respiration signal

Signals

Respiration monitoring Respiratory arrest Battery empty Sensor defective or not connected

visual (green LED (3)) audible, can be cancelled visual (red LED (2)), audible visoual, (yellow LED (5)) visual(yellow LED (4), audible

Sound level

Depending on the pitch 66 – 80 dB(A)

Alarm sound characteristics

6 pitches selectable, frequency range from 2,4 up to 8,5 kHz

Technical Data

Adjustment facilities:

Alarm delay times [sec.] Connections

Alarm delay respiration Sensitivity respiration sensor (in battery compartment) 10, 15, 20, 25 Respiration sensor External alarm

Geometrical data, ambient conditions Operating temperature:

10 – 40° C

Storage temperature:

4 – 50° C

Dimensions: Weight:

L x B x H (in mm): 152x78x29 Approx. 245 g, incl. battery

Regulatory data Classification ac cording to the German Medical Product Act, MPG: CE mark:

II B

CE 1275

We reserve the right to make any modifications. Disposal instructions: Dispose of the packaging sorted according to type of material. W hen you want to dispose of the product, en sure that this is done according to legal requirements. Your local authority will provide you with information.

Maintenance and calibration

Maintenance and calibration SISS BABYCONTROL monitors does not require a regular annual check according to the MPG. However, the manufacturer recommends the following:  Function test of monitors and accessories with every change of patient (referred to as a minor service)  Monitor testing including possible updating of the internal software after 3 calendar years (referred to as a major servi ce) On request, the manufacturer will also provide circuit diagrams, spare parts lists, descriptions, calibration aids and setting instructions for the monitors specified, 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 under warranty can be validated following the above mentioned interventions. Costs: When maintenance is carried out by the manufacturer, the details in the existing up-to-date price list appl y.

Training materials The manufacturer will on request provide training materials for the monitors specified. These cover more detailed descriptions on the monitor family, training aids, FAQ lists, etc.

Technical description

Technical description Accessories Accessory Body sensor USB-Transponder-Pad note:

Length of cables 1.0 m 2.2 m

manufacturer, designation Schulte-Elektronik GmbH, Schulte-Elektronik GmbH

The use of not listed or not released accessory (e.g. other producer’s electrodes / other types) at the SISS BABYCONTROL monitors may cause reduced immunity or rather enhanced electromagnetic emission. The use of the accessory 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. The immunity against electromagnetic environmental phenomena was not tested. The use of the accessory listed above with other electrical medical devices can lead to their reduced immunity and their enhanced electromagnetic emission.

Technical description

Guide and manufacturer’s declaration – electromagnetic emission The SISS BABYONTROL monitors are intended for use as described below. The client or user of thr SISS BABYCONTROL monitors should make sure, that it is used in such an environment. Emission RF-Emission acc. CISPR 11

Compliance Group 1

RF-Emission acc. Class B CISPR 11 Emission of harmonics Not applicable acc. IEC61000-3-2 Emission of voltage Not applicable deviation/ Flicker acc. IEC 610003-3

Electromagnetic environment -Guide The BC SPO2 / ECG uses RFEnergy only for its internal function. Therefore its RF-Emission is very low and it is improbable that electronic devices nearby will be disturbed. The BC SPO2 is suitable for use everywhere, inclusive home area and such, which are connected directly to a public supply network, that also supplies buildings used for habitation.

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 ±6 kV contact discharge

compliance-level

Electromagnetic environment Guide Electro static ±6 kV contact The floor should be made of discharge discharge wood or concrete or should be (ESD ) acc. tiled with ceramic flag. IEC 61000-4-2 ±8 kV air ±8 kV air If the floor contains synthetic discharge discharge material, the relative humidity must be at least 30 %. Fast transients / ±1kV for input and ±1kV for input and The quality of voltage supply Bursts acc. output lines output lines should be equivalent to typical IEC 61000-4-4 business- or clinical environment. Magnetic field at 3 A/m 3 A/m Magnetic fields at mains frequency of supply frequency should be in (50/60 Hz ) acc. accordance with the relevant IEC 61000-4-8 level of business- or clinical environment.

Technical description

Guide and manufacture’s declaration – Electromagnetic immunity The 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 Compliance level Electromagnetic environment – test level guide 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.

conducted RFimmunity acc. IEC 61000-4-6

3Veff

Radiated RFImmunity acc. IEC 61000-4-3

3V/m

150kHz – 80 MHz

80MHz – 800MHz

Recommended protective distance 1,5Veff (c)

3 V/m

800MHz – 2,5GHz 1,5V/m (c)

d  1,17 * P

d  1,77 * P d  2,33 * P

80MHz-800 Mhz

0.8GHz – 2,5GHz

with P as nominal radiated power of the transmitter in Watt (W) acc. to the declaration of the manufacturer of transmitter and d as recommended protective distance in meter (m) The field strength of stationary radio transmitter should be lower at all frequencies than the compliance level (b) acc. to an investigation on site (a) . Nearby devices, which are marked with the following sign, interferences are possible.

Technical description Note 1:

At 80 and 800 MHz the higher frequency range is applicable.

Note 2: This guide may not be applicable in all cases. The electromagnetic propagation depends on the absorption and reflection of buildings, objects and persons. Because it is not possible to predetermine exactly the field strength of stationary transmitters, like e.g. basis stations of wireless telephones and land mobile service, amateur wireless station, AM and FM broadcast and TV broadcast, the electromagnetic environment of the location of the stationary transmitters should be considered and investigated. If the measured field strength at the location, where BC / BCp is used, does not keep the compliance level above, the BC / BCp should be observed to prove the function according its designation. If unusual performance criteria are noticed, additional measures could have to be taken, like e.g. changing the adjustment or the standing place of the BC SPO2 / ECG. In the frequency range from 150 kHz to 80 MHz the field strength should be less than 1,5 V/m . The intention is, to make the Observing-function of the BC / BCp available to a large number of patients. Therefore the BC / BCp works in all measuring channels with high sensitivity modulation. Regarding sensitivity the BC / BCp has a marginal immunity level of 3.0 V in the frequencyrange 150KHz to 80 MHz 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 mobile RF telecommunication equipment (transmitter) and the BC / BCp – depending on the output-power of the communication device, as described below. Protective distance in meter dependant on the transmitter frequency 150 KHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz nominal radiated power of the transmitter in Watt

d  1,17 * P

d  2,33 * P

0,01 0,12 0,12 0,23 0,1 0,37 0,37 0,74 1 1,17 1,17 2,33 10 3,7 3,70 7,37 100 11,7 11,7 23,3 If the maximum nominal radiated power for transmitter is not specified in the table above, the recommended protective distance d in meter (m) can be calculated acc. the equation, that belongs to the respective column. P is the maximum nominal radiated power of the transmitter in Watt (W) according to the declaration of the manufacturer of the transmitter. Note 1: At 80 MHz and 800 MHz the higher range of frequency is applicable. Note 2: This guide may not be applicable in all cases. The propagation of electromagnetic parameter is influenced by absorptions and reflection of buildings, objects and persons. Note 3: If the recommended protective distance can not be kept, BC / BCp should be observed, to check the regular function.

Technical description

The radiated power, frequency, the kind of modulation and the modulation signal itself are relevant for the emission behavior of the transmitter. The list below contains exemplary transmitter and their determined protective distances, which are essentially smaller in parts than listed above. Due to reflections and emissions in the Near-Field of the transmitter it cannot be excluded, that higher field strength can be caused in larger distances, which can lead to interferences. Following the 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, 1.0m GMSK Wireless telephone, DECT 1880-1930 MHz, 250mW, 0.7m GPSK Wireless telephone, CTx 860-930 MHz, 10mW, AM, 0.5m GPSK CB Mobile transmitter device 26/27 MHz, 1W, AM 2.5m AM *) CB Mobile transmitter device 26/27 MHz, 4W, FM 1.0m FM *) PMR-handheld transmitter 446 MHz, 0.5W, FM/PM 0.5m device Babycontroll 27 MHz, 0.1W, FM 0.5m Remote control for toys a.o. 40 MHz, 100mW, AM PWM 0.5m 35 MHz, 100mW, FM PPM *) with 60 cm antenna

(I) Warranty

(I) Warranty We provide a warranty for two years from delivery of the goods to the purchaser. Complaints concerning incomplete or incorrect deliveries or claims concerning discernible deficiencies shall be notified in writing immediately on receipt of the goods and other deficiencies notified in writing immediately on discovery. The purchaser shall preserve right of recourse against third parties (e.g. statement of facts in the case of transport damage). Processing or resale and/ or connection or combination constitute unreserved approval. In the event of prompt notice of defects, we will accept liability within the scope of the following conditions. Our liability for deficiencies (warranty) covers freedom from deficiency of the goods according to the state of the art. Changes to the design or construction, which we undertake prior to delivery against an order, give no entitlement to a claim. To the extent that we have claims under warranty against our suppliers, our warranty is provided by assigning these claims to the 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 s ubsequent 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 compliance is unsuccessful or if we are unable to provide compliance, the purchaser is enti tled to withdraw from the contract or to reduce the purchase price. All above restrictions in liability do not apply to the purchase of consumer goods. Claims by the purchaser to reimbursement of costs incurred within the scope of pursuing claims under war ranty against suppliers is in any case excluded if any cost-incurring actions, in particular the institution of legal proceedings, are not agreed with us in advance. Notwithstanding the above warranty, we as manufacturers offer the purchaser a guarantee a ccording to the provisions below: This guarantee covers all deficiencies resulting from material or manufacturing defects; it applies during a period of 24 months from delivery of the goods and covers, at our option, repair or exchange of goods.

(II) Liability

The guarantee does not apply -

to expendable parts or to natural wear and tear, to paint damage, to damage caused by improper handling, if the delivery item is modified by the purchaser or third parties by the fitting of parts from other suppliers, if additions, readjustments, modifications or repairs have been carried out by persons not authorized to do so by the manufacturer, if the electrical installation of the room concerned does not comply with IEC stipulations, in the event of noncomplian ce with handling directions, to changes or defects due to improper storage, to damage resulting from climatic or other influences.

The provision of services under warranty does not mean that the warranty period recommences in respect of repaired or exchanged parts.

(II) Liability

Manufacturer: SCHULTE- ELEKTRONIK G MBH Schörenbergstr. 20 D-59939 Olsberg Tel. +49 (0) 2962 97 07 -0 Fax. +49 (0) 2962 97 07 -15 www. schulte-elektronik.de inf [email protected] - elektronik.de

BA000221 09/2014

Claims by the purchaser beyond those specified in Clause (I), no matter on which legal grounds, are excluded. W e do not, therefore, accept liability for damage or loss not occurring in the delivery item itself and not for oth er damage to the property of the purchaser. The above exemption from liability does not apply to personal injury; it does not apply to other damage or loss resulting from malicious action or gross negligence; finally it does not apply to damage or loss res ulting from the absence of a characteristic or quality which we have guaranteed. The exclusion of additional liability to compensation does not apply to claims according to Section 1.4 (German) Product Liability Act.

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