SOMNOcheck 2. SOMNOcheck 2 R&K. Sleep Apnoea Basic Diagnostic Package WM Wireless Package WM Polysomnography Package WM 95250

Transcription

1 SOMNOcheck 2 Sleep Apnoea Basic Diagnostic Package WM SOMNOcheck 2 Wireless Package WM SOMNOcheck 2 R&K Polysomnography Package WM Description and Operating Instructions

2 Contents 1. Description Uses Basic unit Sensors Converter box and mains unit.. 5 SOMNOlab PC software SOMNOcheck 2 (2 R&K) device software Non-medical electrical devices. 6 General information on the SOMNOcheck 2 (2 R&K) system as a whole Description of function Function of SOMNOcheck 2 (2 R&K) basic unit Function of the SOMNOlab software Function of the sensors Function of the non-medical units Markings on the medical devices Signals and messages Measuring conditions Pulsoximetry sensor Respiratory flow snore sensor.. 21 Respiratory flow mouth sensor. 22 Respiratory flow nasal cannula 22 Snoring detection Pneumo-T-adapter Position sensor in SOMNOcheck 2 (2 R&K) Thorax sensor Abdomen sensor EXG electrodes Safety instructions SOMNOcheck 2 (2 R&K) medical devices SOMNOlab software Combination with therapy systems Devices Masks Installation System requirements Hardware Operating system Peripheral devices Installation of driver for wireless data transfer Installation of driver for data transfer via the network USB server Installing the driver for the CompactFlash Card reader Installing the software Deinstallation Preparing the SOMNOcheck 2 (2 R&K) connection Connect converter box 40 to PC (communication via cable) 38 Connecting Bluetooth-USB adapter to PC (wireless communication) Connecting network USB server to PC (communication via network) Installing the CompactFlash Card reader Operation SOMNOlab software Starting SOMNOlab Selecting the language Printing the user manual Printing the operating instructions More information on using the software Charging the power pack Applying the SOMNOcheck 2 (2 R&K) system Application printout Instructions for the patient

3 5.4 Applying and positioning electrodes Attaching gold cup electrodes. 49 Positioning for leg EMG Positioning for ECG Positioning EEG electrodes Positioning EOG electrodes.. 52 Electromyogram (EMG) Applying the SOMNOcheck 2 (2 R&K) device and sensors Applying the device Applying the abdomen sensor. 54 Applying the respiratory flow snore sensor Respiratory flow mouth sensor. 56 Respiratory flow nasal cannula 56 Applying the pneumo-t-adapter 57 Applying the pulsoximetry sensor Attaching R&K master cable.. 59 Attaching ECG master cable.. 59 Performing sensor test Begininng and end of measurements Beginning and end of outpatient measurements Beginning and end of inpatient measurements Starting recording manually Important information for your patient Removing the CompactFlash Card Removing the CompactFlash Card Inserting the CompactFlash Card Using the power pack Charging Power pack life Storage Disposal Hygienic preparation Intervals Cleaning Disinfecting Disposable articles Accessories Non-medical devices Functional check Troubleshooting SOMNOcheck 2 (2 R&K) basic unit SOMNOlab software Maintenance, servicing Disposal Product/Replacement Parts/ Accessories Technical data Safe distances Technical data of non-medical components Warranty Declaration of Conformity

4 Overview SOMNOcheck 2 (2 R&K) Left side Front Right side 1 Pressure connection B with stopper 10 Pressure connection A with stopper 2 Electrode connections 3 Connection for 3-pin master ECG cable (SOMNOcheck 2 R&K only) 4 Connection for abdomen sensor 34 2 Electrode connections 11 Thorax sensor 12 Connection for pulsoximetry sensor 5 LEDs 5 LEDs 9 Power pack 6 Button 8 Connection for charging/ data transfer cable 13 Connection for R&K 7 Power pack catch master cable Rear / Electrode connections Top (SOMNOcheck 2 R&K only) 2 Electrode connections 14 Removable card with applications 2 Electrode connections 15 Z electrode 10 (see above), with 1 connection for Connection for 17 or 28 1 (see above), connection for 23 Sensors 17 Respiratory flow snore sensor 18 Sensor beads 19 Sleeve 20 Microphone 21 Base plate 22 Sensor plug 23 Respiratory flow nasal cannula 24 Sleeve 25 Cannulas 26 Saddle 27 Connection 28 Respiratory flow mouth sensor 29 R&K master cable 30 3-pin ECG master cable 31 Pneumo-Tadapter 32 Pulsoximetry sensor 33 Softtip sensor 34 Abdomen sensor

5 Overview PC elements 34 CD-ROM 35 Charger unit 38 Charging/data transfer cable 40 Module for electrical isolation of USB/PC 41 Socket for charging/ data transfer cable 44 CompactFlash Card Belts 37 Plug 36 Mains unit 39 USB cable 42 USB port 43 Socket for charger unit 45 Attachment belt with connecting strap 46 Abdominal belt with connecting strap Examples in use

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7 1. Description Note: These operating instructions describe the SOMNOcheck 2 and SOMNOcheck 2 R&K devices. These operating instructions use the following short form: SOMNOcheck 2 (2 R&K). Sections relating exclusively to the SOMNOcheck 2 R&K device are marked with the text (SOMNOcheck 2 R&K only). 1.1 Uses SOMNOcheck 2 and SOMNOcheck 2 R&K are data recording systems for identifying, recording and storing biosignals during sleep. They are for identifying sleep-related respiratory disorders and associated risk factors, and other sleep disorders (e.g. RLS), to support diagnosis, and for therapy adjustment and monitoring. Fields of use are inpatient and outpatient examinations in sleep laboratories, and outpatient examinations in non-hospital sleep medicine contexts. The measured data are stored in the device on a CompactFlash Card, and transferred to the PC online via cable or, optionally, by wireless link. In inpatient situations, the data stored in the device can either be transferred to the PC via USB port or read into the software by reading the CompactFlash Card with a card reader unit. SOMNOcheck 2 R&K additionally identifies all the parameters necessary for classifying sleep and allows the determination of both Rechtschaffen & Kales sleep stages and arousals. Description 3

8 SOMNOcheck 2 and SOMNOcheck 2 R&K are made up of the following components: Medical device comprising: Basic unit Sensors Application parts Li-Ion power pack Medically approved mains unit (secondary side) with combination cable for charging the power pack and for transferring the stored data to the PC via an electrically isolated USB interface (converter box). SOMNOlab PC software: The SOMNOlab software can be run under the following operating systems: Windows 2000 from SP 2, Windows XP from SP 1 with Internet Explorer 6 or higher. Non-medical electrical devices: Mains unit (primary side) TCP/IP converter Bluetooth-USB adapter CompactFlash Card reader PC system (external accessory). The components have the following intended uses and capture the following sleep-related parameters: Basic unit 4 freely configurable electrophysiological channels (E..G1 /E..G4), which can optionally be set for the parameters EMG, EOG, EEG and ECG with appropriate electrodes; Thoracic and abdominal movements; Oxygen saturation (SpO 2 ; pulsoximetric); Pulse rate (pulsoximetric); 4 Description

9 Nasal flow; Oral and nasal flow; Breathing through the mouth; Snoring; Patient position; xpap pressure; Heart rate; Pulse wave; Oxygen saturation quality index. 1 ECG channel (via master cable) (SOMNOcheck 2 R&K only); 5 ExG channels (via master cable) (SOMNOcheck 2 R&K only). Sensors Electrodes for the electrophysiological channels; Effort sensors (thoracic and abdominal movements); Pulsoximetry sensor for capturing oxygen saturation, pulse rate and pulse wave; Respiratory flow snore sensor (thermistors and microphone); Respiratory flow nasal cannula (pressure sensor); Mouth thermistor for capturing mouth breathing during therapy monitoring; Pneumo-T-adapter for capturing respiratory flow, snoring and xpap pressure (pressure sensor). Converter box and mains unit The converter box 40 is used to transfer the data stored in the device by cable. Data transfer is via a USB interface. The converter box electrically isolates the de- Description 5

10 vice from the USB interface. At the same time SOMNOcheck 2 (2 R&K) is charged via the mains unit, or continuously supplied with power. SOMNOlab PC software The SOMNOlab PC software is used to capture, store, process, visualise, analyse, document and archive patient-related biosignals. This provides support for diagnosis, therapy adjustment and therapy monitoring of sleep disorders. SOMNOcheck 2 (2 R&K) device software The SOMNOcheck 2 (2 R&K) device software is used to capture, store, process and analyse biosignals. This provides support for diagnosis, therapy adjustment and therapy monitoring of sleep disorders. The device software communicates with the PC software by means of a secure data transfer protocol. Non-medical electrical devices Reader for reading the data stored on the CompactFlash Card; Online module for wireless data transfer (Bluetooth-USB adapter); USB - TCP/IP converter; PC system (external accessory). General information on the SOMNOcheck 2 (2 R&K) system as a whole SOMNOcheck 2 (2 R&K) generates information signals (e.g. power pack charging status), which are visualised in graphic form and stored by the PC system. These information signals are used to check the presence of the signals to be recorded, and also the functioning of the device. This avoids 6 Description

11 faulty recordings, which would otherwise make it necessary to repeat night measurements. The system does not generate alarms. The automatic analyses (PLM, snoring, sleep stages, arousal and cardiorespiratory analysis) are performed offline on the basis of the signals stored in the PC and help the analyst to diagnose sleep disorders and to carry out therapy adjustment and monitoring. As far as electrical safety is concerned, the electrical isolation between basic unit and PC system ensures that PC systems do not form part of the SOMNOcheck 2 (2 R&K) basic unit. The PC system used must comply with EN The PC software is used to visualise, analyse, document and archive patient-specific long-term examinations with a view to diagnosing sleep disorders. The system is configured for this purpose and the transferred data are automatically analysed offline. The software enables the user to enter comments. Manual reclassification of the analysis results by the user is possible. The system is designed for persons with a body weight of at least 45 kg, using the sensors specified by WEINMANN. The medical staff prepare the measurement, operate the SOMNOlab software and charge the power pack. The EEG electrodes for the master cable are attached to the patient and connected to the system by medical staff (SOMNOcheck 2 R&K only). After instruction from medical staff, patients are able, with the aid of the patient operating instructions, to put on the sensors and device themselves (SOMNOcheck 2 only). Description 7

12 1.2 Description of function Function of SOMNOcheck 2 (2 R&K) basic unit SOMNOcheck 2 (2 R&K) processes all signals and stores them on the integrated CompactFlash Card. The data are transferred from the card either via a USB cable or by inserting the CompactFlash Card in a card reader. In stationary use the SOMNOcheck 2 (2 R&K) can transfer the captured data online, either by wireless link or by cable, to the SOMNOlab software, which ensures additional storage of the data. For online monitoring with SOMNOcheck 2 (2 R&K) it is possible to use existing clinic networks. For example, if data are lost on leaving the examination room, you can use the data stored on the CompactFlash Card to add the missing data. SOMNOcheck 2 (2 R&K) draws its power from an interchangeable power pack, making it independent of the mains. No stored measurements are lost when changing the power pack. However, after 30 minutes without the power pack or a power supply, the device will have to be reconfigured. You can also use the data transfer cable as a permanent power source for operating the unit. SOMNOcheck 2 (2 R&K) has a built-in position sensor. The sensor registers whether and when patients are lying on their front, back or side. The device also possesses an effort sensor integrated in the unit. This integration reduces the amount of cleaning and increases the life of the sensor. Double-clicking button 6 starts a sensor test / impedance check. In a sensor test / impedance check the LEDs allow you to establish whether and which electrodes are properly 8 Description

13 or poorly applied and to check that the sensors are properly seated. SOMNOcheck 2 (2 R&K) also indicates by a yellow LED next to the battery symbol in the power pack whether the power pack is charging. The charging status can also be checked via the software, as a capacity monitoring function is integrated in the power pack. The converter box with integrated electrical isolation can be used to transfer the stored data to the PC. The converter box can also be used to charge the power pack with the mains unit supplied. A power pack module can be charged even if it is not inserted in the device. Note: ARTISANA sleep stage and arousal analysis was validated using SOMNOcheck 2 R&K. Please use your SOMNOcheck 2 R&K only with ARTISANA. To do this, activate ARTISANA under "Analysis criteria in the SOMNOlab software. Function of the SOMNOlab software The data transferred during the measurements are stored and visualised. The data read in after the measurement are automatically analysed in terms of time and value criteria and the presence of respiratory disorders is registered. The SOMNOlab software can perform the following automatic analyses: PLM analysis Snoring analysis Cardiorespiratory analysis Arousal analysis Sleep stages analysis. On the basis of the analysis results and the signals shown, you can evaluate the results in accordance with your own criteria. Description 9

14 Function of the sensors Respiratory flow nasal cannula 23 In conjunction with the pressure sensor integrated in the SOMNOcheck 2 (2 R&K), the respiratory flow nasal cannula registers respiratory flow and snoring. Inhalation is registered via the underpressure generated, exhalation via the overpressure. Snoring creates pressure fluctuations in the nostrils, which are also registered. With the mouth closed, the pressure measurement reacts more sensitively to slight flow restrictions than thermal measurement. It is independent of the ambient temperature and also permits a visual assessment of the flow contour over time. If the mouth is open, the signals may be weaker. We therefore recommend using the respiratory flow mouth sensor at the same time. The signal representation and the automatic analysis are geared to the original WEINMANN nasal cannula. Pulsoximetry sensor 32 The pulsoximetry sensor is used to measure the patient's pulsoximetric signals, blood oxygen saturation and pulse rate. Note: The pulse rate changes measured correspond sufficiently closely to the heart rate changes brought about by a sleep-related apnoea syndrome. The main elements of the sensor are two LEDs and a receiver diode. Several SpO 2 values are determined for each pulse wave (split pulse wave algorithm). For every oxygen saturation value, SOMNOcheck 2 (2 R&K) calculates a quality index that indicates the quality (accuracy) of the SpO 2 value measured. If movements interfere with the signal, the number of usable measured values will be lower. If the signals are free from interference, a large number of values are received. Accordingly a faulty signal yields a low quality index, while a clear signal results in a high quality index. 10 Description

15 The quality signal can assume values ranging from 0 to 100 %. The quality signal can be helpful when assessing long-term SpO 2 measurements, because it points to the occurrence of artefacts during measurement. Thorax sensor 11 and abdomen sensor 34 The thorax and abdomen sensors are used to capture the thoracic and abdominal respiratory movements. Such movements cause changes in the tension forces acting on the measuring detectors in the attachment belts. The piezoelectric effect in the measuring detectors is used to convert the movements into electrical signals. Electrophysiological signals The electrophysiological signals are measured with the aid of electrodes. Gold cup or adhesive electrodes may be used for this purpose. Electroencephalogram (EEG) The EEG records electrical activity in the brain, called brainwaves, by measuring and recording voltage fluctuations with the aid of electrodes. In polysomnography, the EEG can provide information about sleep stages, for example. Electrooculogram (EOG) The EOG registers eye movements. It registers voltages generated by eye movements as an electric dipole in neighbouring electrodes. Description 11

16 Electromyogram (EMG) The EMG registers muscle activity in the chin or legs. The chin EMG is needed to distinguish the various sleep stages. The leg EMG is used specifically for diagnosing the Restless Legs Syndrome (RLS) and Periodic Leg Movement Syndrome (PLMS). Electrocardiogram (ECG) The ECG registers the electrical currents that occur between specific sites on the skin as a result of heart activity. SOMNOcheck 2 (2 R&K) can be used to detect changes in or disorders of cardiac rhythm. Respiratory flow snore sensor 17 The respiratory flow snore sensor enables you to register your patient's nasal and oral respiratory flow and snoring sounds. The sensor beads consist of thermistors. They detect respiratory flow using the difference in temperature between exhaled and inhaled air. The microphone registers the patient's snoring sounds. Respiratory flow mouth sensor 28 With the respiratory flow mouth sensor you can register your patient's oral respiratory flow during diagnosis with the respiratory flow nasal cannula, and during therapy adjustment and monitoring. The sensor beads consist of thermistors. They detect respiratory flow using the difference in temperature between exhaled and inhaled air. 12 Description

17 Pneumo-T-adapter 31 The pneumo-t-adapter is used in therapy monitoring in conjunction with a nasal mask. It registers your patient's respiratory flow and snoring during therapy and measures the therapy pressure present in the mask. The pressure measurement tubes conduct inhalatory and exhalatory pressure fluctuations from the mask to the device. Breathing out cause a slight overpressure, breathing in a certain overpressure. The pressure differences indicate the breaths. Snoring sounds are measured through rapid pressure changes. The therapy pressure is deduced from the static component of the pressure signal. Function of the non-medical units Note that all non-medical units must be installed outside the direct vicinity of the patient, i.e. at a distance of at least 1.5 m. Bluetooth-USB adapter The Bluetooth-USB adapter can be used to receive data online from the SOMNOcheck 2 (2 R&K) without a cable connection, to configure the device, and to perform an application check. Network USB server With this USB server you can run SOMNOcheck 2 (2 R&K) through a network. This is necessary in many sleep laboratories if the patient's room is at a distance from the recording room. By using the USB server in conjunction with the Bluetooth- USB adapter you can receive data from the SOMNOcheck 2 (2 R&K) by wireless link, configure the device, and perform an application check. If preferred, you can establish a cable connection to the SOMNOcheck 2 (2 R&K) via the converter box. Description 13

18 Note that the USB server must not be installed in the direct vicinity of the patient. CompactFlash Card reader You can use the CompactFlash Card reader to read out the data stored on the CompactFlash Card taken from the SOMNOcheck 2 (2 R&K). You can also use the CompactFlash Card reader to configure the SOMNOcheck 2 (2 R&K) and create two or more CompactFlash Cards with different configurations. CF Card 14 Description

19 1.3 Markings on the medical devices The symbols on the back of the device have the following meanings: Symbol Meaning Date of manufacture Power supply/direct current; connection for mains unit (converter box) Observe operating instructions CE mark Medical device of type BF IPX 0 SN xxxx II a Not protected against water entry Serial number Classification under EC Directive 93/42/EEC To be used once only 1-8 Z Free electrophysiological inputs A, B Pressure connections A SOMNOcheck 2 (2 R&K) connection (converter box) B Mains unit connection (converter box) C PC connection (converter box) Power pack CompactFlash Card Respiratory flow nasal cannula / Respiratory flow snore sensor / Respiratory flow mouth sensor Description 15

20 Symbol Meaning Application sites of sensors Class II Electronic scrap mut not be disposed of as household waste! All consumers have a statutory obligation to deliver all end-of-life devices containing electronic components, batteries and rechargeable power packs, whether or not they contain pollutants, to a local authority collection centre or to the trade to ensure that they are sent for environmentally sound disposal. Make sure batteries and rechargeable power packs are discharged when you hand them in. Humidity during operation, transport and storage Transport and storage temperatures Protect from moisture Fragile HF transmitter 16 Description

21 1.4 Signals and messages So that you can always be sure of trouble-free measurements, SOMNOcheck 2 (2 R&K) has visual signal indicators. These take the form of light-emitting diodes (LEDs). LED Status Meaning LEDs at memory card Light green, flashing. Green, flashing slowly (1x per sec.). Green, flashes 10 times (2x per sec.). Green, flashing quickly (4x per sec.). Yellow, continuous Yellow, flashing (2x per sec.). Device is switched on Wireless link established. Start of recording. Device is being configured or stored measurement being transferred to PC. No memory card in device. Memory card full. LEDs for respiratory inputs Green, flashing (1x per sec.). No sensor signal. LEDs for electrodes Flashing quickly (4x per sec.). Goes out after impedance measurement. Impedance being measured. Electrode impedance < 5 kω, in order. Electrode impedance Flashing slowly (1x in 2 seconds). < 10 kω, not optimal, but acceptable quality. Flashing (1x per sec.). Electrode impedance > 10 kω (check electrode, signal quality not acceptable). Description 17

22 LED Status Meaning 3 LEDs on left are on continuously. Power pack life < 6 h or less than configured measuring time. Charge power pack. All LEDs on device LEDs on power pack container SOMNOcheck 2 R&K ONLY: during impedance measurement: all three LEDs of the respiratory Note: inputs flashing impedance values for simultaneously the electrodes can be called up in the SOMNOlab software. Off. No LED on. Left LED is green. Right LED is yellow, continuous or flashing. Device is switched off or recording in progress. Power pack not connected to mains. Power pack connected to mains. Power pack is being charged. Power pack is fully Left LED green, right LED off. charged. Flashing quickly (4x a second). Go out after the impedance measurement. Flashing slowly (1x every 2 seconds). Flashing (1x a second). Measuring impedance of electrodes at R&K master cable A maximum of one of the electrodes on the R&K master cable has 5-10 kω, signal quality not ideal but acceptable. Several electrodes on the R&K master cable have 5-10 kω, no electrode > 10 kω, signal quality not ideal but acceptable. At least one electrode on the R&K master cable has more than 10 kω (check electrode, unacceptable signal quality) 18 Description

23 LED Status Meaning SOMNOcheck 2 R&K ONLY: During impedance measurement: LED at ECG master cable connection flashing Note: impedance values for the electrodes can be called up in the SOMNOlab software Flashing quickly (4x a second). Goes out after impedance measurement. N Flashing slowly (1x every 2 seconds). Flashing (1x a second). Impedance of electrodes at ECG master cable A maximum of one of the electrodes on the ECG master cable has 5-10 kω, signal quality not ideal but acceptable. Several electrodes on the ECG master cable have 5-10 kω, no electrode > 10 kω, signal quality not ideal but acceptable. At least one electrode on the ECG master cable has more than 10 kω (check electrode, unacceptable signal quality) Note: If poor impedance (> 10 kω) is measured for the R&K and the ECG master cables, the LEDs on the device do not indicate which of the individual electrodes has poor impedance. In this case, use the SOMNOlab software to call up the values for the individual electrodes to determine the faulty electrode. 1.5 Measuring conditions Observe the instructions on applying the sensors and accessories. Dirty sensors, e.g. due to secretions, electrode paste residues or moisture, can result in incorrect measurements. If the instructions are observed, the product is not sensitive to environmental influences. Description 19

24 Caution! The recommended duration of using the pulsoximetry sensor on one finger is approx. 4 hours. After this time, attach the sensor to a different finger to prevent poor circulation or faulty measurements. Pulsoximetry sensor Make sure that the LEDs and the receiver in the sensor are not dirty or moist. The pulsoximetry sensor is calibrated by reference measurement using fractional saturation measurement to pulsoximetric haemoglobin oxygen saturation in the case of blood free of dysfunctional haemoglobin. The functional oxygen saturation of arterial blood is determined with the aid of the pulsoximetry sensor on the finger of the patient, in other words non-invasively. If the proportion of dysfunctional haemoglobin (e.g. carboxyhaemoglobin or methaemoglobin) is high, it will impair measuring precision. Disruptions to the measuring signal are monitored by the device. The device issues error messages if the faults are outside the limits specified internally. The device then restricts its measuring mode. "0" values are displayed. Normal ambient light is compensated by the sensor. Particularly strong or fluctuating ambient light from direct sunlight or theatre lamps, for example, may falsify measuring results. The device then restricts its measuring mode. "0" values are displayed. Pulsation strength may be impaired. This is the case, for example, when blood pressure cuffs or arterial catheters are used, also in the case of arterial occlusion or if the sensor is applied too tightly. The device detects movement artefacts, suppresses them almost completely with the aid of different algorithms and issues a message as soon as they are too high. There is a possibility of false measured values being displayed if movement artefacts last too long. 20 Description

25 In the event of a high proportion of dysfunctional haemoglobins (e.g. carboxyhaemoglobin or methaemoglobin), measurement may deliver a normal result even though the patient is hypoxic. Intravascular dyes like methylene blue, indocyan green or other dyes considerably falsify the measured result. Artificial nails made of acrylic may affect measuring precision and should be removed before measuring starts. Note: If the sensor is covered by bedding, the ambient temperature rises to body temperature, which can cause faulty measurements. Respiratory flow snore sensor Measurement of the respiratory flow curve is based on a temperature difference measurement between the inhaled and exhaled air flow. For this reason an unsatisfactory signal is registered if the ambient temperature is between 33 C and 38 C. The sensor beads 18 must lie precisely in the nasal and oral air flow. The sensor beads must not be covered with impurities such as secretions, otherwise faulty measurements may occur. The membrane covering the microphone 20 must not be damaged. The microphone of the respiratory flow snore sensor registers not only the snoring sounds made by your patient, but also nearby noises that have frequencies typical of snoring. Make sure that the surrounding noise level is considerably lower than the volume of the snoring sounds. You can use the respiratory flow snore sensor at the same time as the respiratory flow nasal cannula. Description 21

26 Note: If the sensor is covered by bedding, the ambient temperature rises to body temperature, which can cause faulty measurements. Respiratory flow mouth sensor Measurement of the respiratory flow curve is based on a temperature difference measurement between the inhaled and exhaled air flow. For this reason an unsatisfactory signal is registered if the ambient temperature is between 33 C and 38 C. The sensor bead must lie precisely in the oral air flow. The sensor bead must not be covered with impurities such as secretions, otherwise faulty measurements may occur. You can use the respiratory flow mouth sensor at the same time as the respiratory flow nasal cannula. The sensor must not be re-used until it has dried thoroughly. Respiratory flow nasal cannula The respiratory flow nasal cannula is used as an alternative to the thermistor with microphone (respiratory flow snore sensor). The respiratory flow nasal cannula is used for diagnostic measurement. It cannot be used at the same time as the pneumo-t-adapter for xpap measurements. It registers the difference between nasal pressure and ambient pressure. Lage quantities of secretions (colds) or blood (nose bleeds) can impair measurement of respiratory flow and snoring. External sounds (e.g. traffic noise) can affect measurement of snoring. The respiratory flow nasal cannula must be connected directly to the pressure measurement con- 22 Description

27 nection B. If you use the wrong connection you will obtain incorrect measurements for respiratory flow and for snoring detection. The cardiorespiratory analysis no longer functions properly. Do not use damaged nasal cannulas. The tube must not be pinched or otherwise restricted during measurement. The respiratory flow nasal cannula is designed to be used once only. To obtain correct measurements, you should open the second pressure connection as well during measurement. Snoring detection Snoring detection is performed primarily with the respiratory flow nasal cannula. If snoring detection is to be performed with the respiratory flow snore sensor, the respiratory flow nasal cannula must be deactivated. If the pneumo-t-adapter is connected, snoring detection automatically takes place with the pneumo-t-adapter. Pneumo-T-adapter The pneumo-t-adapter is used for therapy adjustment and therapy monitoring in conjunction with xpap devices. The pneumo-t-adapter can be used in conjunction with the respiratory flow mouth sensor so that breathing through the mouth can be detected. Lage quantities of secretions (colds) or blood (nose bleeds) can impair measurement of respiratory flow and snoring. Make sure the pressure measurement tubes are correctly connected to the pneumo-t-adapter and the device. If the tubes are connected the wrong Description 23

28 way round, the record will show inhalation and exhalation the wrong way round. The pneumo-t-adapter and the pressure measurement tubes must be clean and free from moisture. The pressure measurement tube must not be kinked. The pneumo-t-adapter must be securely attached to the mask, ensuring a firm seal. The internal measuring tube of the therapy device should not be routed through the pneumo-t-adapter, as this could cause inaccurate measurements. Position sensor in SOMNOcheck 2 (2 R&K) The position sensor integrated in the device only functions properly if SOMNOcheck 2 (2 R&K) is attached using the belts in accordance with these instructions, otherwise faulty measurements may occur. Thorax sensor Two protected thorax sensors are integrated in the device. These sensors record respiratory movements of the thorax. They are made of a skin-friendly plastic material. The T-belt is for attaching the thorax sensors and the device to the patient s body. The yellow coded T-belt is for normal sizes, the green T-belt for outsize patients. Choose the appropriate belt for your patient. Make sure that the belt is sufficiently taut when you apply the sensors. Insufficient tension can result in a loss of signal amplitude or complete loss of signal. On the other hand the belt must not cut into the patient. Your patient must be able to breathe freely. The belt consists of a skin-friendly, elastic and fleecy band. 24 Description

29 Abdomen sensor The abdomen sensor is used in conjunction with the abdominal belts. It registers adbominal respiratory movements. The sensor is made of skin-friendly plastic material. EXG electrodes The parameter registered with the electrodes is voltage. What is measured is a potential difference between two points on the body. Since the measurement is non-invasive and is made on the surface of the skin, the potential differences that can be measured are very small. For EEG, EOG and EMG they are in the µv region, for ECG in the mv region. The crucial factor for the quality of the measurement is the electrical resistance between skin and electrode and the gap between the two. The impedance can be reduced by thorough cleaning, degreasing and slight roughening of the skin, and by using electrode gel. The reference electrode (Z electrode) plays a significant role in the derivations. It guarantees a common reference potential for the electronics. Description 25

30 2. Safety instructions Please read these operating instructions carefully. They are an integral part of the device and must be kept available for reference at all times. Always use the device only for the purpose described (see 1.1 Uses on page 3). For your own safety and that of your patients, and in accordance with the requirements of Directive 93/42/EEC, please observe the following points: SOMNOcheck 2 (2 R&K) medical devices Warning! Before using a defibrillator, all parts of the system must be completely removed from the patient. SOMNOcheck 2 (2 R&K) must not be operated in an atmosphere where there is a risk of explosion. Before cleaning the SOMNOcheck 2 (2 R&K), be sure to unplug the mains unit, the power pack, and all mains plugs of any devices connected to the SOMNOcheck 2 (2 R&K). Do not feed mains voltage into the device via the electrode cables or push-in connectors. Do not touch the patient if you are holding the mains unit connection cable in your hand and the mains unit is still plugged into the wall socket. Caution! The system must not be used for monitoring vital functions. The system generates information signals. These information signals are used to check the presence of the signals to be recorded, and also the functioning of the device. It does not generate alarms. The PC on which the data are stored and visualised, and its peripheral components (e.g. printer) 26 Safety instructions

31 and non-medical devices must not be in the immediate vicinity of the patient (within 1.5 m). Accessory equipment connected to the analogue and digital interfaces of the device must demonstrably comply with the corresponding EN specifications (e.g. EN for data processing devices and EN for electromedical devices). Furthermore, all configurations must comply with the version of the system standard EN in force at the time they are put on the market. Anyone who connects additional devices to the signal input or output unit is a system configurator and is thus responsible for ensuring compliance with the valid version of the system standard EN If you have any questions, contact your local dealer or WEINMANN Customer Service. Follow the operating instructions and the brief operating instructions for existing older system components you want to use with the SOMNOcheck 2 (2 R&K). SOMNOcheck 2 (2 R&K) must only be used by trained staff with adequate specialist knowledge. Malfunctions and a lack of biocompatibility may result if third-party articles are used. Note that in such cases all warranty entitlement and liability claims shall be void where items other than the accessories recommended in the instructions for use or original spare parts are used. SOMNOcheck 2 (2 R&K) components must not be immersed in liquids. Moisture entering the device during operation and storage impairs the functioning and safety of the device. Before using the device, replace all parts that are damaged, worn or contaminated. Only the manufacturer or specialist personnel may perform repairs and inspections or open the de- Safety instructions 27

32 vice. Unauthorised opening of the device makes the guarantee void. WEINMANN is not liable for the functioning and safety of the device in the event of any incorrect handling or use of the device by the owner or operator that is not in accordance with the intended use set out in these operating instructions. Use the device only in conjunction with the original WEINMANN mains unit. Devices that generate electromagnetic fields must not be operated in the vicinity of the SOMNOcheck 2 (2 R&K). Faults or incorrect measurements can be caused by the following devices, for example: Interference with an electrosurgical unit X-ray sources Magnetic resonance tomographs Radio signals (cordless telephones, mobile phones, etc.) High-voltage lines Electrostimulation devices. Do not run the SOMNOcheck 2 (2 R&K) at the same time as devices that input energy into the body, such as electrostimulation devices. SOMNOcheck 2 (2 R&K) may be used on patients fitted with cardiac pacemakers. The device may only be operated and stored in compliance with the ambient conditions specified in the technical data. Observe the cleaning and disinfecting instructions in these operating instructions. Insert all sensor plugs in the prescribed sockets. Make sure the sensors and sensor cables are applied in accordance with the instructions. Incorrectly applied sensor cables can cause injuries. 28 Safety instructions

33 The device can supply incorrect measurements if the patient takes substances that alter the colour of the blood or the physiological parameters measured. If you use multi-way sockets, only connect devices of the SOMNOlab system to them. Movable multi-way sockets must not be placed on the floor. Do not use extension cables to connect the SOMNOcheck 2 (2 R&K). The electrodes applied to the patient have electrical contact with other conductive parts of the medical device. The electrodes must not be in contact with other conductive components including earth that do not belong to SOMNOcheck 2 (2 R&K). Do not connect any third-party devices to the SOMNOcheck 2 R&K (e.g. devices with 1.5 mm jacks). Note that a safe distance must be maintained between SOMNOcheck 2 (2 R&K) and equipment that emits HF radiation (e.g. mobile phones), otherwise malfunctions may occur (see 13.1 Safe distances on page 84). Using other accessories, other transformers and cables than those specified can result in increased radiation by the device or system or reduced immunity to interference. SOMNOcheck 2 (2 R&K) and its associated parts must not come into contact with injured, damaged and/or infected skin when applied to the patient. Note Be sure to observe the regulations in force when disposing of the accessory parts from your medical zone. Safety instructions 29

34 SOMNOlab software Note Observe the Online Help included in the software. Apart from the SOMNOlab software, no other software released by WEINMANN for the purpose may be installed or operated on the computer. 30 Safety instructions

35 3. Combination with therapy systems 3.1 Devices Note: You can combine SOMNOcheck 2 (2 R&K) as control system with the usual CPAP, BiLevel and APAP therapy systems. The two systems can be coupled quickly and easily using the pneumo-t-adapter, which is inserted between tube and mask. The pneumo-t-adapter for the SOMNOcheck 2 (2 R&K) has been tested with all WEINMANN therapy devices. If third-party devices are used, the increased flow resistance may result in the trigger function being restricted. 3.2 Masks Important! Be sure to observe the instructions for the mask as well. SOMNOcheck 2 (2 R&K) can be combined with the usual masks employed in the field of sleep apnoea. These must be equipped with a connection complying with DIN EN ISO Combination with therapy systems 31

36 4. Installation 4.1 System requirements Make sure that the PC and its components are safely installed on a firm surface and cannot tip over or fall down. For trouble-free installations of the SOMNOlab software, you need an IBM-compatible computer that meets the following requirements: Hardware Processor: Pentium III or better, at least 1 GHz Memory: at least 128 MB (RAM) Free storage capacity: at least 500 MB hard disk capacity Operating system Microsoft Windows 2000 from SP 2, Windows XP from SP 1 with Internet Explorer 6 or higher Peripheral devices USB-Port : Windows supported, USB 1.1 Ports: USB ports for connecting card reader, USB connection to data logger and Bluetooth-USB adapter Graphics card: supported by Microsoft Windows, min. resolution 1024x768, colour depth 16 bit Monitor at least 17" CRT monitor or 15" TFT monitor 32 Installation

37 Mouse Windows -compatible mouse Printer: supported by Microsoft Windows Network: network card, 10/100 Mbit (only when using the network USB server) Microsoft, Microsoft Windows, Windows, and Internet Explorer are registered trademarks of the Microsoft Corporation in the USA and/or other countries. Pentium is a trade mark of the Intel Corporation in the USA and other countries. 4.2 Installation of driver for wireless data transfer Note for all USB devices: The relevant software drivers must be installed before you connect USB devices to your PC. For further information, see the operating instructions for the Bluetooth-USB adapter. Our hotline is available to help you install the Bluetooth-USB adapter. 4.3 Installation of driver for data transfer via the network USB server For further information, please consult the operating instruction for the USB server. Our hotline is available to help you install the USB server. Installation 33

38 4.4 Installing the driver for the CompactFlash Card reader For further information, please consult the operating instructions for the CompactFlash Card reader. Our hotline is available to help you with the installation of the CompactFlash Card reader. 4.5 Installing the software Note: The drivers for the USB peripherals must be installed before the SOMNOlab software. Install the SOMNOlab software before you connect the device by means of a USB cable. In order to avoid incorrect use of the software during operation, deinstallation or updates, observe the Online Help as well. If you have any questions or problems please contact your local dealer or send an to: somnocheck.hotline@weinmann.de 1. Start Windows. If you have already started Windows, exit all open applications before installing the SOMNOlab software. 2. Insert the CD-ROM. Your computer starts installation automatically. 3. You will be taken through all subsequent installation steps by various dialogue boxes (see During installation ). Press Next to continue with the installation; Press Back to return to the previous dialogue; Press Cancel to stop the installation. You can stop the installation process at any time. 34 Installation

39 During installation 1. The installation program checks the operating system for the presence of the required Internet Explorer. Various dialogues are shown to inform you whether the required Internet Explorer is present: The required Internet Explorer is present in your operating system. Click OK to continue with installation. Go to step 3. of the installation instructions. The required Internet Explorer could not be found in your operating system. Confirm with OK to start installing Internet Explorer. 2. The SOMNOlab software is supplied with Internet Explorer 6.0 SP1 in German, English, French and Italian on a CD. Select the language of your operating system. Installation of Internet Explorer starts automatically. If your operating system does not support any of the languages mentioned, select Other languages. This cancels the installation. Before you can proceed with installation, you must first install Internet Explorer in your language. The latest Internet Explorer is available in many languages for free downloading from the Microsoft website. After installing Internet Explorer, start the installation of SOMNOlab again. Resume the procedure at step 1.. Installation 35

40 3. In the dialogue that follows, enter your user name and the department for which you are installing the SOMNOlab software. If you are installing the SOMNOlab software on a Windows 2000 or Windows XP operating system, the installer suggests that you install the software for all users of the computer. If you do not want anyone except yourself to use the SOMNOlab software, click on Only for me. 4. The installer program suggests an installation folder. If you want to accept this path, click on Next. If you want to specify a different path, click on Change and enter a new path. 5. The installer will suggest a folder for storing the measured data. If you want to accept this path, click on Next. If you want to specify a different path, click on Change and enter a new path. 6. The installer is now ready to proceed with the installation. Click on Install. 7. The installer copies the required files from the CD-ROM to the hard disk. 36 Installation

41 8. The installation has been successful if this window appears. Click Finish to complete the installation process. After installing the SOMNOlab software, you need to install the remote adjustment module SOMNOadjust. To do so, repeat steps 1. to Deinstallation 1. Click on the Start symbol at the bottom left of the desktop. 2. Click on Settings, then select Control Panel from the submenu. 3. In the Control Panel window, double-click on Software. 4. Select SOMNOlab Software or SOMNOmanager from the selection list, then click Remove. Installation 37

42 4.7 Preparing the SOMNOcheck 2 (2 R&K) connection Data transfer from the SOMNOcheck 2 (2 R&K) to the PC, and configuration of the device in relation to the PC, are effected via a USB interface. Note: The PC system must be switched off before connecting the converter box. Note: The end of the cable marked red must be plugged into the battery block. Connect converter box 40 to PC (communication via cable) To protect the user and patient, an electrical isolation system which isolates the device from the PC is integrated in the converter box. The converter box must always be used when communicating with the PC or charging the power pack. 1. Insert the USB cable 39 in port 42 (marked C) on the converter box, and the other end in a free USB port on the PC. If you have more than one SOMNOcheck 2 (2 R&K) system, make sure that the connections for the individual devices are correct. 2. Connect the mains unit to the socket 43 (marked B) on the converter box. 3. Insert the SOMNOcheck 2 (2 R&K) cable in socket 8 on the power pack block, and the other end into socket 41 (marked A) on the converter box. 4. Plug the mains unit into a wall outlet. Save yourself work. Leave the mains unit plugged into a wall outlet and the PC plug plugged into your PC. In this way you will always have the plug for SOMNOcheck 2 (2 R&K) handy on your desk. The system is now ready for operation. 38 Installation

43 Connecting Bluetooth-USB adapter to PC (wireless communication) Insert the Bluetooth-USB adapter in a free USB port on your PCs or in the USB port of the USB server. The software drivers must already be installed. The system is now ready for operation. Connecting network USB server to PC (communication via network) Connect the USB server to the network as described in the operating instructions for the USB server. Now insert the Bluetooth-USB adapter or the converter cable with USB plug into the USB port on the USB server Initial commissioning should be carried out by a WEINMANN SOMNOlab product specialist. For this purpose please contact our hotline (see Page 34). Installing the CompactFlash Card reader Connect the CompactFlash Card reader to the PC as described in its operating instructions. Installation 39

44 5. Operation In this chapter you will find all the information you need for ordinary use of the SOMNOcheck 2 (2 R&K) system. All additional applications and explanations within the SOMNOlab software and the higher-level data management program SOMNOmanager can be found in the Online Help, which contains a printable software manual. You can find it by selecting the menu item? / Manual. Note: Sensor application and use of the device and power pack of SOMNOcheck 2 (2 R&K) is described from Page 45 onwards. Please read this chapter carefully. The brief operating instructions "SOMNOlab in 7 steps" and all other SOMNOcheck 2 (2 R&K) operating instructions can also be found on our home page: SOMNOlab software Remember that what the software for detecting sleep-related breathing disorders provides is a suggested analysis. The analysis results produced automatically may only be assessed by the doctor supervising treatment or other specialist staff. Do not expose the CD to strong sunlight. This could result in loss of data. Do not bend the CD. Protect the CD from scratches, as this could result in data becoming unreadable. Incorrect operation may be caused by: Corruption or confusion of recorded data, Changes in parameter files, Incorrect language settings. Observe the Online Help included in the software. 40 Operation

45 Starting SOMNOlab 1. If the SOMNOlab icon is available directly on your desktop (as a shortcut), open the program by double-clicking on the icon. If the SOMNOlab icon is not on the desktop, you can start the program as follows: 2. Select, in the following order, the menu items Start, Programs, SOMNOlab. 3. Select the SOMNOlab icon to start the program. Selecting the language 1. In the Tools menu, select Options. In the window that appears, activate the tab card General. 2. Click on English. From now on the program will run in English. The next time the program is started, it will automatically open in English. The setting remains unchanged until you select a different language. Looking up a Help text 1. First start the Online Help. There are two ways of doing this: press the F1 key or click on the button. Under Contents the Online Help gives you an overview af all Help topics and menu items. Under Index you can select keywords from a list, and under Search you can find and display all Help topics for a keyword. 2. To open the Help text: Operation 41

46 Under Contents: Click the topic to open the Help text. Under Index you open the Help text by doubleclicking on the desired keyword. Under Search you enter a suitable search word. The topics found are shown in a list. Printing the user manual By selecting? / Manual from the menu you can open all topics in the Online Help as a pdf document. Here you are also offered a table of contents and an index. You can also print the manual. Printing the operating instructions By selecting? / Usage Guide from the menu you can open the SOMNOcheck 2 (2 R&K) operating instructions as a pdf document. As well as additional information on SOMNOcheck 2 (2 R&K), it also offers many helpful illustrations and a table of contents. You can also print the operating instructions. 42 Operation

47 Printing the Online Help 1. Open the Online Help. 2. Click on the Print icon. 3. In the menu that now appears, choose whether you want to print only the selected topic or all subtopics as well, then confirm by clicking OK. 4. In the Print dialogue, select the printer, then click on Print. The Online Help is now printed. Note: More information on using the software Consult the Online Help for more details about operation and the software. Among other things, the Online Help describes: How to prepare and configure the device for outpatient and inpatient measurements. How to configure and set visualisation. How the measurements are made. How the measurements are analysed. Before you hand over the SOMNOcheck 2 (2 R&K) system to your patient, you can make a status check to satisfy yourself that all settings and the current time of day for SOMNOcheck 2 (2 R&K) are correct. Check all the settings. If you discover any incorrect settings, program SOMNOcheck 2 (2 R&K) again. Every time the SOMNOcheck 2 (2 R&K) is re-programmed, the time in the basic unit is synchronised with the system clock of your PC. You should Operation 43

48 therefore make sure that the time is set correctly on your PC, otherwise the recording will begin at the wrong time. If data transfer to the PC is interrupted, the measured data remain stored in the device. The software shows the signals as a zero line. You can read out all the data the next day. Please note that incorrect setting of the visualisation configuration may result in misinterpretations. Note that channels that are deactivated in the device configuration are not transferred. The configuration of the visualisation does not affect storage of the data. If you are running several devices, check for correct assignment between device < > PC. 5.2 Charging the power pack Note: Before you use SOMNOcheck 2 (2 R&K), you need to charge the power pack. You can use the mains unit supplied 36 to charge the power pack in the device or, if you have two power packs, charge it externally. In the latter case, you can give the device to a new patient immediately without having to wait. 1. Connect the mains unit to the marked socket in the converter box. 2. Insert the charging/transfer cable in the socket in the power pack, and the other end in the converter box. 3. Plug the mains unit 36 into a wall outlet. The yellow LED 5 next to the battery symbol on the power pack lights up. 44 Operation

49 Note: 4. Keep charging the power pack until the yellow lamp on the power pack goes out. Save yourself work. Leave the mains unit plugged into a wall outlet and the PC plug plugged into your PC. In this way you will always have the plug for SOMNOcheck 2 (2 R&K) handy on your desk. To make your power pack last longer, observe the chapter on "6. Using the power pack" on page Applying the SOMNOcheck 2 (2 R&K) system The product package and accessories of SOMNOcheck 2 (2 R&K) include the following components necessary for application: 3-point attachment belt with quick-release catch (2 sizes) 2-point attachment belt with quick-release catch (2 sizes) Abdomen sensor Pulsoximetry sensor Respiratory flow snore sensor Respiratory flow nasal cannula Electrodes and electrode cables Pneumo-T-adapter Adhesive electrodes. The scope of supply of SOMNOcheck 2 R&K also includes the following components: Master cable for EEG electrodes ECG master cable Strap for attaching R&K master cable. Operation 45

50 Note: Make sure that all belts, sensors and cables are attached to the patient in such a way that they do not cut into the patient or restrict his breathing in any way. Your patient must be able to breathe freely. Make things as easy as possible for your patient. Place the SOMNOcheck 2 (2 R&K) system on your patient so he can try it out. Show him and explain to him clearly how to put on the sensors at night without your help and how he can run a test to check that the sensors are properly seated. The sequence of operations for applying the sensors and the device is described in the operating summary for the patient. Undo only the side quick-release catch of the belt when you remove the SOMNOcheck 2 (2 R&K) system from your patient again. Give your patient the SOMNOcheck 2 (2 R&K) system in the carrying bag. This protects the device and the sensors. Make sure that the power pack is charged before you apply the SOMNOcheck 2 (2 R&K) system to the patient and hand it over to him for the measurements. The power pack must be fully charged before using it for the first time. Your patient should apply the sensor himself under your guidance. Application printout When programming the SOMNOcheck 2 (2 R&K) you can get the software to print out the programmed configuration. The printout provides a visual representation of the configuration. Instructions for the patient You can use the SOMNOlab software to print out the patient instructions in the relevant language. 46 Operation

51 5.4 Applying and positioning electrodes Operation 47

52 Connections on the basic device: Channel (connection 1 and 2) (connection 3 and 4) (connection 5 and 6) (connection 7 and 8) Z Connection 1 = Plus pole 2 = Minus pole 3 = Minus pole 4 = Plus pole 5 = Minus pole 6 = Plus pole 7 = Minus pole 8 = Plus pole Neutral electrode (always connect) Note: 1. First apply all adhesive electrodes or gold cup electrodes to the appropriate parts of the patient's body, as described in the following sections. 2. Attach the electrode cables to the electrodes by means of the snap fasteners. When doing so, observe the colour coding on the application printout and on the back of the device. 3. Then insert the plugs of the electrode cables in the appropriately coloured ports of the SOMNOcheck 2 (2 R&K). Do not apply the electrodes too close together, as this could short-circuit the cables. In that case you would no longer receive any signal. 4. Plug the R&K master cable into the port provided (SOMNOcheck 2 R&K only). 5. Plug the ECG master cable into the port provided (SOMNOcheck 2 R&K only). Before every recording, always perform an electrode impedance measurement to check for proper functioning. Do not make any parallel connections of electrodes to other systems. If you do so, there is no 48 Operation

53 guarantee that SOMNOcheck 2 (2 R&K) will function properly. Ensure that the electrodes are connected correctly, otherwise you will get false analysis results and signal displays. Do not connect any third-party devices with 1.5 mm jacks to the SOMNOcheck 2 (2 R&K). EEG, EOG and mental or submental EMG are essential parameters for polysomnography. Correct positioning of the electrodes for these three measuring variables is described in the "Manual of standardized terminology, techniques and scoring systems for sleep stages of human subjects" by RECHTSCHAFFEN and KALES (1968). Attaching gold cup electrodes 1. Clean the chosen site on the skin with physiological saline solution (NaCI 0.9 %) or alcohol. A cotton bud and/or gauze pad is suitable for this purpose. 2. Then roughen the skin with the skin preparation paste supplied. Use your finger to rub a little adhesive conducting paste into the skin; this improves conductivity and provides a good surface for the electrode to stick to. 3. Then fill the recess in the electrode with a peasized or slightly larger portion of adhesive conduction paste and press the electrode firmly onto the skin so that the paste squeezes out round the edge. 4. Place a piece of gauze over the electrode and the squeezed-out paste, then press it firmly against the skin again. Make sure that the edge of the electrode is making firm contact with the skin, thus completing the conductive surface This ensures that the paste in the electrode will not lose its conductivity by drying out. Operation 49

54 5. Use a plaster strip for additional fixation of each electrode cable This reduces the tension on the cable and ensures reliable connections throughout the night. For EMGs you can also use disposable adhesive electrodes. Clean the skin as for gold cup electrodes and fix the electrodes with plasters. Note: Apply the electrodes very carefully. The quality of the measurements depends on a good adhesive bond, because the interface between skin and electrode is very prone to contact problems. Poor adhesion of electrodes increases the number of artefacts and can make it more difficult to assess the recording. Before each measurement, clean the electrodes with alcohol or saline solution. Observe the instructions for the adhesive electrodes, gels and pastes with regard to skin compatibility and allergic reactions to the materials used. You should also observe the keepability dates of the gels, pastes and electrodes used. Positioning for leg EMG A bipolar lead connection is used for the leg EMG. The first lead is connected 4 fingers below the point of attachment of the patellar ligament and one finger to the side of the front edge of the shin bone (tibia), and the second lead 5 cm below the first. You can also use disposable adhesive electrodes for the leg EMG. Clean the skin as for gold cup electrodes. Fix the electrode cable with several strips of plaster. This prevents the cable falling off due to movements by the patient. 50 Operation

55 Positioning for ECG As for EMGs, a bipolar connection is also used for ECGs. The polysomnograph trace for SOMNOcheck 2 (2 R&K) is based on the Einthoven method. Apply the negative, red-coded electrode to the sternal attachment point of the second rib on the right of the body (as seen by the patient), and the positive, yellow or green coded electrode to the apex of the heart. In addition to the derivation electrodes, a further earth electrode must be affixed as an electrical reference. The black reference electrode is affixed as shown in the adjacent illustration. Use the disposable adhesive electrodes supplied to set up the ECG. The skin is cleaned in the same way as for other electrophysiological signals. Fix the electrode cable with a plaster. This prevents the cable falling off due to movements by the patient. Tip: Positioning EEG electrodes In order to perform a proper Rechtschaffen and Kales sleep derivation, the EEG electrodes are affixed using the 10:20 system. You need derivations C3 and/or C4 to register the EEG during sleep. As reference electrodes, use the ear or mastoid electrodes of the opposite side. This will give you derivations C3 - A2/M2 and/or C4 A1/M1. In addition to the EEG electrodes, an additional earth electrode must be affixed to the forehead as electrical reference (Z). Use the mastoid electrodes (M1/M2) as reference. They are easier to affix and not as susceptible to faults as ear electrodes (A1/A2). Operation 51

56 Positioning EOG electrodes SOMNOcheck 2 (2 R&K) has 2 channels for deriving eye movements. Position one electrode approx. 1 cm above and slightly to the side of the edge of the right eye. Like the EEG, the reference electrode is on the mastoid or earlobe on the same side. Affix the second electrode approx. 1 cm below it and again somewhat to the side of the edge of the left eye. The reference is the ear or mastoid electrode on the same side. This arrangement records EOG signals in REM sleep and in the awake state out-of--phase. Artefacts and EEG signals are shown in-phase with this arrangement. Electromyogram (EMG) The EMG registers muscle activities at the chin/legs. The EMG is for recording physiological and pathological movement activity of the body or of individual extremities. Note: the EMG on the chin is required for differentiating between the different sleep stages. The EMG for the legs is specifically for diagnosing restless legs syndrome (RLS) and periodic leg movement in sleep syndrome (PLMS). 52 Operation

57 5.5 Applying the SOMNOcheck 2 (2 R&K) device and sensors Note: SOMNOcheck 2 (2 R&K) and its associated parts must not come into contact with injured or infected skin. Any wounds must be bandaged first with a stable bandage. Instruct your patient to wear nightwear under the system. The product as supplied includes different belts 45. The yellow coded belts are of normal size, while the green coded belts are for outsize individuals. Choose the appropriate belt for your patient. Note that the coloured ends of the belts go on the right side of the body. Use the 3-point belt to attach the SOMNOcheck 2 (2 R&K) basic device to the patient's body. c a b Applying the device 1. Feed the belt first through the upper ring a on the device, then through the lateral ring b. 2. Hang the resulting loop over the patient's left shoulder. 3. Now feed the short connecting piece with quickrelease lock through the remaining ring c, and fasten the belt with the buckle. 4. Use the adjustable velcro-type strips to adjust the belt to fit the patient's body. It should be a firm but comfortable fit on the body. Note: Before applying the device, attach the adhesive electrodes and electrode cables. Make sure the device is well fitted. It should be located on the breastbone (sternum). Operation 53

58 Attach the device to your patient firmly, but comfortably. The sensors integrated in the device will only function properly if this is the case. Otherwise faulty measurements may occur. Ensure that the belt is always taut against the body and that sensors and cables are attached correctly but do not impede blood flow at any point. Your patient must still be able to breathe freely. The belt consists of a skin-friendly, elastic and fleecy band. Make sure the SOMNOcheck 2 (2 R&K) is prepared in this way before handing it over to your patient. This ensures that the patient can always put it on quickly and correctly. black Applying the abdomen sensor The abdominal belt 46 is used to attach the abdomen sensor 34 to your patient's body. The yellow coded abdominal belt is for normal sizes, the green coded belt for outsize patients. Choose the appropriate belt for your patient. The belt must not cut into the patient. Your patient must be able to breathe freely. The belt consists of a skin-friendly, elastic and fleecy band. The abdomen sensor 34 is used in conjunction with the abdominal belts. The abdomen sensor registers abdominal respiratory movements. 1. Feed the short connecting piece with quick-release catch through the ring on the sensor. Abdomen sensor 54 Operation

59 2. Run the abdominal belt round the patient's waist and feed the abdominal belt through the other ring on the sensor. The sensor must be located centrally on the abdomen. 3. Fasten the belt with the buckle. 4. Make sure that the belt is always firm on the body, otherwise it cannot register the movements due to breathing. 5. Connect the sensor to socket 4 on the device. Applying the respiratory flow snore sensor You use the respiratory flow snore sensor for diagnostic purposes. 1. Unwind the sensor from the base plate. Place the sensor on the patient's upper lip. Make sure that the microphone is on the side away from the skin, i.e. remains visible. 2. Run the cable over the patient's ears and pull it taut under the chin by sliding the sleeve up. 3. Connect the plug of the respiratory flow snore sensor to the round socket 16 on the top of the device. 4. Close the pressure connections 1 and 10 with the stoppers supplied. 5. After measurement, place the sensor on the base plate again to prevent it getting bent and wind the cable around the sensor and the base plate. The base plate, like the sensor, can be cleaned and disinfected. Operation 55

60 Respiratory flow mouth sensor The respiratory flow mouth sensor 28 is used for diagnostic purposes together with the respiratory flow nasal cannula or, for therapy control or adjustment, to register breathing through the mouth in conjunction with the pneumo-t-adapter Unwind the sensor from the base plate. Place the sensor on the patient's lower lip. Make sure that the sensor beads are facing into the mouth. 2. Run the cable over the patient's ears and pull it taut under the chin by sliding the sleeve up. 3. Connect the plug of the mouth thermistor to the round socket 16 on the top of the device. 4. Close the pressure connections 1 and 10 with the stoppers supplied. 5. After measurement, place the sensor on the base plate again to prevent it getting bent and wind the cable around the sensor and the base plate. The base plate, like the sensor, can be cleaned and disinfected. Note: Respiratory flow nasal cannula You use the respiratory flow nasal cannula for diagnostic purposes. You can use the respiratory flow nasal cannula 23 at the same time as the respiratory flow mouth sensor Remove both stoppers (if present) from the pressure connections 1 and 10 of the SOMNOcheck 2 (2 R&K) and screw the tube of the nasal cannula on to the connection B marked with the nasal cannula symbol. 56 Operation

61 2. Hold the double tube on the right and left so that the cannulas point upwards. 3. Now place the cannulas in the patient's nostrils and run the tubes over the ears and down under the chin. Adjust the sleeve where they join so that the tube is lying loose on the body without slipping out of place. Lubricating the nostrils slightly, e.g. with petroleum jelly, can help to improve comfort and prevent drying out. Note: Applying the pneumo-t-adapter The pneumo-t-adapter 31 is used for therapy adjustment and therapy monitoring in conjunction with xpap devices. The pneumo-t-adapter can be used in conjunction with the respiratory flow mouth sensor 28 so that breathing through the mouth can be detected. 1. Ensure that an external exhalation system is connected to the mask. 2. Connect the soft end of the Pneumo-T-adapter to the external exhalation system of the mask. 3. Now connect the breathing tube to the hard side of the Pneumo-T-adapter. The internal measuring tube of the therapy device should not be routed through the pneumo-t-adapter, as this could cause inaccurate measurements. 4. Push the ends of the double tube onto the connectors of the pneumo-t-adapter as follows: the tube marked red onto connector A of the adapter (likewise marked red) the other tube onto connector B. Operation 57

62 Important: 5. Screw the tube on the adapter connector nearer to the breathing mask (marked in red) to pressure connector A on the device. 6. Screw the other tube onto the other pressure connection. Make sure the pressure measurement tubes are correctly connected to the pneumo-t-adapter and the device. If the tubes are connected the wrong way round, the record will show inhalation and exhalation the wrong way round. The connection on the pneumo-t-adapters that points towards the mask must always be connected to A on the device. Otherwise the software will not show the respiration phases correctly. Applying the pulsoximetry sensor Use the pulsoximetry sensor only in conjunction with SOMNOcheck 2 (2 R&K). If you are simultaneously monitoring your patient's blood pressure with a sphygmomanometer, do not attach the pulsoximetry sensor to the arm wearing the cuff. 1. Attach the pulsoximetry sensor to an index finger. Make sure that the finger symbol is on top. The sensor should be attached securely, but comfortably. It must not squeeze the finger. 2. If necessary, fix the sensor by sticking the sensor cable to the finger with adhesive tape. Note: No adhesive tape must be attatched to the body of the sensor. 58 Operation

63 3. Insert the sensor plug into the socket on the SOMNOcheck 2 (2 R&K). Make sure that the plug is firmly inserted. Attaching R&K master cable 1. Affix the electrodes for the EEGs and EOGs as described from Page Plug the jack for the R&K master cable into port 13. Attaching ECG master cable 1. Affix the electrodes for the ECG as described from Page Plug the jack for the ECG master cable into port 3. 6 Performing sensor test So that you and the patient can be sure that all sensors are properly connected, you should perform a test after applying the sensors and the devices. You start the sensor test or impedance measurement by briefly pressing button 6 on the SOMNOcheck 2 (2 R&K) twice in succession or by selecting the impedance measurement on the PC. See also section "1.4 Signals and messages on page 16. Process Sensor test in progress Sensor test ok Device During the sensor test, the LED of the sensor being tested flashes quickly (4x per second). The LED for the relevant signal stops flashing after the end of the impedance test: Electrode impedance < 5 kω, in order, or sensor signal present. Operation 59

64 Process Sensor test moderate Sensor test not ok Device The LED for the relevant signal flashes slowly after the end of the impedance test: Electrode impedance <10 kω, not optimal, but acceptable quality. Green LEDs flash slowly at 0.5Hz. The LED for the relevant signal flashes quickly after the end of the impedance test: Electrode impedance > 10 kω or no sensor signal (check electrode or sensor, unacceptable signal quality). Green LEDs flash quickly at 1Hz. Note: Note: If poor impedance (> 10 kω) is measured for the R&K and the ECG master cables, the LEDs on the device do not indicate which of the individual electrodes has poor impedance. In this case, use the SOMNOlab software to call up the values for the individual electrodes to determine the faulty electrode. Once the electrodes/sensors have been attached successfully, the relevant LED on the SOMNOcheck 2 (2 R&K) goes out. From then on there is no further change in the status of the LEDs on the SOMNOcheck 2 (2 R&K) in the next step when the sensor test is ended by closing the impedance window in the software. The sensor test checks all channels, including effort and pulsoximetry sensors, and the thermistor and nasal cannula for the presence of a signal. If the LED is off, this means: Sensor is connected and transmitting a (physiological) signal. An impedance test runs once through all configured channels and then displays the result until the window is closed or a new test is started. Correct traces and correct performance of automatic analyses are only possible with a low impedance value. For optimal signal quality we 60 Operation

65 recommend trying to achieve a "LED inactive" status for all channels. For application control on the PC screen, observe the plausibility of the signals. If a signal is not displayed, check the device configuration and the visualisation configuration. If both are present and you are still not receiving a signal, this is an indication that the sensor is faulty. 5.6 Begininng and end of measurements Beginning and end of outpatient measurements Switch on the SOMNOcheck 2 (2 R&K) for configuration by pressing button 6. The device automatically switches off again after 10 minutes if you do not take any further action (e.g. sensor test). After configuration you can also switch the device off again manually by pressing button 6. SOMNOcheck 2 (2 R&K) switches on at the time set for the beginning of measurements and starts recording. SOMNOcheck 2 (2 R&K) switches off automatically at the programmed end time. After the measurements the patient takes off the sensors and and the SOMNOcheck 2 (2 R&K) basic unit and puts all parts in the carrying bag. Beginning and end of inpatient measurements Switch on the SOMNOcheck 2 (2 R&K). SOMNOcheck 2 (2 R&K) starts immediately when recording is started in the SOMNOlab software. Operation 61

66 Starting recording manually It is possible to start recording manually. This function must be activated in the software under Tools/Options. Once the function is activated, the device must be configured once. Only then can you start a recording manually independently of a configuration. This is done by pressing button 6 for three seconds. The configuration for the preceding measurement is always used for this purpose. For further details of operation, e.g. setting the duration of measurement, please consult the software. 5.7 Important information for your patient Observe the following points to ensure that you and your patient do not have problems with annoying faulty measurements: Never open the device. SOMNOcheck 2 (2 R&K) must be attached firmly but comfortably to the body so that the position of the body is recorded correctly. The effort sensors must always be firmly seated for optimal recording of the movements due to breathing. For example, the cable of the pulsoximetry sensor should be secured to the patient's finger or hand by a plaster strip. This means the cable does not get in the way and the sensor cannot slip. If necessary, the patient should sleep alone and/ or with the window shut, in order to prevent external noises affecting the measurements. The sensors must be clean and dry. Impurities, such as secretions, should be wiped off carefully (e.g. after sneezing). 62 Operation

67 You can run the cable of the pulsoximetry sensor down inside your patient's pyjama sleeve before you place the sensor on his finger. The patient should avoid pulling the sheets or pillow over his head. This would cause a sharp rise in the ambient temperature, causing the respiratory flow snore sensor to supply incorrect measurements. The nail of the index finger on which the pulsoximetry sensor is placed must not be painted with coloured varnish. A measurement will likewise supply falsified results if it was performed on fingers with artificial nails made of acrylic. If the pulsoximetry sensor causes unpleasant pressure, the patient can place it on a different finger. Before measurement starts, check that the sensors and electrodes are properly seated. If the impedance between electrodes and skin is too high, e.g. due to poor electrode adhesion, the traces will be unsatisfactory. Check the electrodes for proper seating and electrical properties. You can check the quality of electrode application with an impedance measurement (see Performing sensor test on page 59). The measurements are not lost if the power pack is not in the device, but the power pack must not be removed from the device while measurement is in progress. Tell your patient that after putting on the equipment he must be able to see the microphone 20 on the respiratory flow snore sensor 17 when he looks in the mirror. Tell your patient to check the belts again for a firm fit after lying down. Operation 63

68 5.8 Removing the CompactFlash Card To read or change the CompactFlash Card, proceed as follows: Removing the CompactFlash Card 1. Remove the power pack by pressing the catch 7 and pulling the power pack out of its holder. 2. Briefly press the button to the left of the inserted CompactFlash Card. The button is now projecting slightly. 3. Press the button again, this time until it clicks into place and is flush with the housing. This pushes the CompactFlash Card slightly out of the device, enabling you to pull it out. Inserting the CompactFlash Card 1. Push the CompactFlash Card (with the contact holes towards the device and the printing visible) into the device until it slots into place with a click and is flush with the housing. 2. Push the power pack into the SOMNOcheck 2 (2 R&K) until it snaps into place with an audible click. 64 Operation

69 6. Using the power pack Caution! SOMNOcheck 2 (2 R&K) has a high-capacity lithiumion power pack. The electronic system for charging is integrated into the power pack. This permits continuous capacity monitoring. If a fault in the power pack is detected (e.g. capacity too low), a visual warning is given by the LEDs on the device. When you remove the battery, you must insert a new or recharged battery within 30 minutes, as SOMNOcheck 2 (2 R&K) will otherwise have to be reconfigured for any offline measurement planned. You can also remove the power pack from the SOMNOcheck 2 (2 R&K) and charge it using the USB-charging cable in conjunction with the electrical isolation module and the mains unit. If you have a second power pack, you can give the device to your new patient immediately and charge up the empty power pack later. For how to proceed when removing/changing the battery, see the section "6.2 Power pack life on page 66. The power pack configuration is checked every time the device is configured, and the PC software/ firmware generates an information signal. 6.1 Charging Make sure that you charge the power pack fully after a long measurement session. SOMNOcheck 2 (2 R&K) power packs can be recharged at any time. There is no memory effect. Using the power pack 65

70 It does not do any harm either to charge them up fully in several stages, with or without partial discharging in between. In normal day-to-day operation the SOMNOcheck 2 (2 R&K) power pack should not be fully discharged, i.e. you should not use SOMNOcheck 2 (2 R&K) until it switches off automatically. If it is always fully discharged, this does not directly reduce its capacity, but the number of possible charging cycles is greatly reduced. This means the life of the power pack decreases if used frequently. For maintenance purposes you should fully discharge the SOMNOcheck 2 (2 R&K) power pack every 4-6 months and recharge it. SOMNOcheck 2 (2 R&K) has an intelligent power pack. The power pack contains an integrated electronic system. Among other things, this determines the capacity in order to calculate the running time displayed. To discharge the power pack, configure a 12-hour measurement session without charging the power pack first. This power pack does not tolerate deep discharge. A deep discharge can for example be caused by storage for several months without any recharging. The capacity of the power pack is continuously reduced by cell oxidation. This process takes place faster at higher temperatures and higher charge capacity. The self-discharge of a Li-Ion power pack as a result of its internal chemical processes and the energy required by the protection circuit is around 3-10% per month. The power pack can be used and discharged at temperatures between +5 C and +40 C. Charging is only possible at power pack temperatures between +5 C and +35 C. 66 Using the power pack

71 Charging time increases at temperatures of over 25 C. 6.2 Power pack life Li-Ion power packs have a life of about 500 charging cycles. An incomplete discharging/ charging process also counts as a charging cycle. If not charged, its life is 1 year. Protect the power pack from heat. If the power pack is exposed to temperatures of over +60 C (e.g. direct sunlight inside a car) for lengthy periods, there is a permanent loss of capacity. Replace the power pack when it reaches the end of its life. Remove the power pack by pressing the catch 7 and pulling the power pack out of its holder. Inserting the power pack: Push the power pack into the SOMNOcheck 2 (2 R&K) until it snaps into place with an audible click. 6.3 Storage Power packs should be stored 50% charged and at room temperature. Li-Ion power packs age fast at high storage temperatures and when fully charged. Using the power pack 67

72 6.4 Disposal Do not dispose of the unit as domestic waste. To dispose of the unit properly, please contact a licensed and certified electronic waste recycler. Names and addresses can be obtained from your Environmental Officer or municipal authorities. 68 Using the power pack

73 7. Hygienic preparation Note: When cleaning and disinfecting this equipment, be sure to observe the relevant official regulations and recommendations. 7.1 Intervals Part When? Cleaning Disinfecting After every use. Before change of patient Cleaning by hand SOMNOcheck 2 (2 R&K) basic unit Pneumo-T-adapter Pulsoximetry sensor (observe product information leaflet) Washing machine Wiping Respiratory flow snore sensor Respiratory flow mouth sensor Abdomen sensor Snap electrodes, gold cup electrodes and electrode cables (observe product information leaflet) Bags and belts USB charging cable R&K master cable ECG master cable Power pack Respiratory flow nasal cannula Adhesive electrodes from electrode set Tubes for Pneumo-T-adapter Disposable article Disposable article Disposable article Spraying Immersion Hygienic preparation 69

74 7.2 Cleaning With mild detergent or damp cloth You can wipe down all the components of the SOMNOcheck 2 (2 R&K) using a slightly damp cloth and a mild detergent. If the Pneumo-T-adapter is very dirty, you can also immerse it in a weak soap solution. Caution! Caution! Allow all components to dry completely in air before using them again. No liquid must be allowed to enter the SOMNOcheck 2 (2 R&K) or the sockets or connections. The sensors must not be immersed in liquids. Before cleaning, be sure to use the stoppers to close the pressure connections on the device. Removing the power pack block. Before cleaning, always disconnect the charging and transfer cable from the power pack and unplug the mains unit from the wall outlet. With Washing machine The carrying bag and the belts can be machine washed at 40 C. Let bags and belts air-dry thoroughly. Do not use a dryer! Remove the abdomen sensor first. 7.3 Disinfecting If necessary, i.e. after infectious diseases or if parts have become unusually dirty, you can disinfect certain 70 Hygienic preparation

75 parts by wiping them with or immersing them in disinfectant (see 7.1 Intervals on page 69). Observe the instructions for the disinfectant used. We recommend you to wear suitable gloves (e.g. household or disposable gloves) during disinfection procedures. Disinfecting by wiping with Terralin. Take a disposable cloth and spray it with disinfectant. Then wipe the relevant part with it. Disinfecting by spraying with Microzid Liquid Spray. Disinfecting by immersing in GIGASEPT FF. 7.4 Disposable articles For hygiene reasons, do not re-use disposable articles. You should dispose of nasal cannulas etc. as household waste. Sleep laboratories/hospital facilities must observe the relevant hygiene regulations. 7.5 Accessories Please observe the information provided with the individual accessory. 7.6 Non-medical devices Observe the information on cleaning in the instructions for use supplied with the individual components. Hygienic preparation 71

76 8. Functional check Take the following measures before using the device each time and after every installation: Make sure that all devices and sensors used are undamaged and fully functioning. For this purpose you can perform an online application control using the PC. To do this, attach the SOMNOcheck 2 (2 R&K) system and all its sensors and electrodes and perform a measurement on yourself. You can assess the plausibility of the data on the PC. In particular, check the electrode cables for proper functioning. You should replace them after not more than 50 applications. Connect SOMNOcheck 2 (2 R&K) to the PC by wireless link or using the data transfer cable. Make sure that the device with the appropriate data transfer cables or the CompactFlash Card reader is properly connected to the PC. Start the SOMNOlab software. Select the appropriate data transfer method and start a measurement. Carry out this test with the USB data transfer cable, the wireless module and, if appropriate, with the USB server. Configure the device using the CompactFlash Card reader. Make a short recording and then read the data from the card. Check the communication between the SOMNOcheck 2 (2 R&K) components and the PC system by starting the sensor test and impedance measurement and testing the functioning of the sensors. Check the signals for plausibility. You can use the SOMNOcheck 2 (2 R&K) on yourself to test the functioning of the sensors or the device. This function check does not replace the checks on the device which are performed during servicing. 72 Functional check

77 9. Troubleshooting 9.1 SOMNOcheck 2 (2 R&K) basic unit Fault Cause Rectifying faults No signal in flow, snoring, effort and/or pulsoximetry channel. A signal curve displays an unphysiological trace. The ECG/the other EXG channels show a zero line. SOMNOcheck 2 (2 R&K) does not show any signals. The electrophysiological signals are noisy. No connection can be established with SOMNOcheck 2 (2 R&K). The mains supply light is not on. The respiratory flow snore sensor and/or pulsoximetry sensor are not applied. The plug-in connectors are not correctly connected. The sensors are dirty, damp or faulty. The plug-in connectors are not correctly connected. The electrodes are dirty, damp or faulty. The electrodes have slipped or got dirty during measurement. The sensor has slipped or got dirty during measurement. The impedance between skin and electrodes is too great. The plug-in connectors are not correctly connected. The channels were not configured in the display. The channels were not configured in measuring mode. The cables are receiving interference or interfering with each other. Wireless link faulty. The cable link between the device and the PC is interrupted. The mains unit is not plugged into the wall outlet. Attach the missing sensor. Push the connections firmly together. Clean the sensors and wipe them dry. Push the connections firmly together. Perform a sensor test before or during measurement. Clean the electrodes and wipe them dry. Repeat the measurement with cleaned or replacement electrodes. Repeat the measurement with cleaned or replacement sensors. Clean the skin and use new electrodes. Push the connections firmly together. Configure the channels. Repeat the measurement with correct configuration. Route the electrode cables differently. All data are also stored internally in the device. You can read out the data the next day. Check all the cable connections. Plug in the mains unit. Troubleshooting 73

78 The power pack is not delivering any power. Fault Cause Rectifying faults Yellow LED on power pack flashing. Contact springs not making contact. Power pack has been charged more than 500 times, maximum capacity no longer reached. Software message. Power pack faulty, e.g. due to short-circuit or faulty charging circuit. Take out the power pack and put it in again. Replace the power pack. Replace the power pack. Ambient temperature when charging is too high (e.g. device lying Charge power pack at lower ambient temperature. on window sill in the sun). 9.2 SOMNOlab software Fault Cause Rectifying faults The program cannot establish a connection with SOMNOcheck 2 (2 R&K). The wireless link is interrupted. The PC transfer cable is not connected to the PC. The corresponding diagnosis device is not activated. All data are also stored internally in the device. You can read out the data the next day. Connect the cable. Activate the device under Extras/ Options/General in the SOMNOlab PC software. 74 Troubleshooting

79 10. Maintenance, servicing SOMNOcheck 2 (2 R&K) must be serviced every two years by the manufacturer or qualified specialist dealer to ensure proper functioning. The following tasks are performed: A functional check is made in the SOMNOcheck 2 (2 R&K). The pressure sensor for xpap pressure and flow measurement is tested and if necessary recalibrated. If pressure calibration is necessary, this is notified automatically in your SOMNOlab software under Comments. The electrophysiological amplifiers are checked for accuracy and if necessary recalibrated. The function and precision of all sensors and jacks of the SOMNOcheck 2 (2 R&K) are checked. Defective and dirty parts are replaced. If SOMNOcheck 2 (2 R&K) is used daily, replace the CompactFlash Card every two years. Also observe the chapter on 6. Using the power pack on page Disposal Do not dispose of the device as household waste. To ensure proper disposal of the device, consult an authorized and certified electronic scrap recovery firm. You can find out their address from your environmental officer or your municipal authorities. Maintenance, servicing 75

80 12. Product/Replacement Parts/ Accessories 1. SOMNOcheck 2, sleep apnoea diagnosis basic package WM SOMNOcheck 2, wireless package WM SOMNOcheck 2, complete package WM SOMNOcheck 2 R&K Polysomnographie-Paket WM E = Extent of supply R = Replacement part Order No. Article WM SOMNOcheck 2 basic unit WM E / R WM WM WM WM SOMNOcheck 2 basic unit, wireless E / R E / R WM SOMNOcheck 2 R&K basic unit E / R WM Power pack with capacity control E / R E / R E / R E / R WM Abdomen sensor loop E / R E / R E / R E / R WM Respiratory flow / snore nasal cannula, package of 10 E / R E / R E / R E / R WM Fixing strap 1.1 m (yellow end) E / R E / R E / R E / R WM Fixing strap 1.5 m (green end) E / R E / R E / R E / R WM Fixing strap for abdomen 1.5 m (green end) E / R E / R E / R E / R WM Fixing strap for abdomen 1.1 m (yellow end) E / R E / R E / R E / R WM x extension strap with 40 mm catch E / R E / R E / R E / R WM Carrying case E / R E / R E / R E / R WM SOMNOlab software E / R E / R E / R E / R WM Operating instructions SOMNOcheck 2 (2 R&K), English E / R E / R E / R E / R WM Set, mains unit E / R E / R E / R E / R WM USB charging cable E / R E / R E / R E / R WM USB transfer cable E / R E / R E / R E / R WM Module for electrical isolation of USB/PC E / R E / R E / R E / R WM CompactFlash Card, 512 MB E / R E / R E / R E / R WM Set, electrodes E / R E / R E / R E / R 76 Product/Replacement Parts/Accessories

81 Order No. WM Set, removable cards E / R E / R E / R E / R WM Pneumo-T-adapter incl. 5 tubes E / R E / R E / R E / R WM Set, R&K electrodes E / R E WM R&K master cable E / R E WM ECG master cable E / R E WM R&K master cable attachment material E / R E Pulsoximeter sensors Order No. Article WM WM WM WM Softtip sensor SpO 2, size S R R R R WM Softtip sensor SpO 2, size M R R R R WM WM Softtip sensor SpO 2, size L E / R E / R E / R E / R WM Article Pulsoximeter clip sensor, Minimed 90, 140 cm cable WM WM WM R R R R WM Flow-/snore measurement therapy control Order No. Article WM WM WM WM WM Respiratory flow-snore sensor for adults, large R R R E / R WM Respiratory flow mouth sensor R R R R WM Respiratory flow-snore nasal cannula R R R E / R WM Set, respiratory flow nasal cannula to sense snoring E / R E / R E / R E / R WM Respiratory flow-snore nasal cannula, package of 50 R R R E / R WM Set of 100 diagnostic nasal cannulas, 330 mm, and 1 adapter R R R R WM Set, tubes for pneumo-t-adapter (20 pieces) R R R E / R WM Flexible tube adapter R R R E / R WM Sealing cap for pressure measuring connection R R R R Product/Replacement Parts/Accessories 77

82 Data transfer Order No. Article WM WM WM WM WM USB server TCP/IP R R R E / R WM USB transmission cable, 2 m E / R E / R E / R E / R WM Bluetooth-USB adapter for wireless, 5 m R E / R E / R E / R WM CompactFlash Card reader R R R E / R WM Wireless module R E / R WM R&K module R E / R Power supply options Order No. Article WM WM WM WM WM Primary adapter GB R R R E / R WM Primary adapter USA/Japan R R R E / R WM Primary adapter AU/NZ R R R E / R 78 Product/Replacement Parts/Accessories

83 13. Technical data SOMNOcheck 2 (2 R&K) basic unit Product class under 93/42/EEC Dimensions (W x H x D) Weight (device without sensors) Temperature range: Operation Storage Power supply voltage, Basic unit Power supply voltage, Power pack Mean power consumption Power pack operation: wireless online outpatient Max. recording time for one session Mains unit, connections Classification under EN Protection against electric shock Degree of protection against electric shock Electromagnetic compatibility (EMC) acc. to EN Radio interference suppression Radio interference resistance IIa 80 x 150 x 34 mm approx. 300 g +5 C to +40 C* 10 C to +60 C 3.7 V DC 7.5 V DC approx. 340 mw approx. 10 h approx. 20 h 12 h Input: V, Hz, 400 ma Output: 7.5V DC Class II Type BF (the test parameters and threshold values are obtainable from the manufacturer on request) EN EN Parts 2 to 6 and 11 Degree of protection against water entry IPX 0 Rel. humidity during 25 to 95%, non-condensing operation and storage Air pressure during 700 to 1060 hpa operation and storage Storage medium Data transfer online Reading stored data Carrier frequency Compact Flash card, max. 512 MB Wireless (radio signals) at 2.4 GHz. From USB 1.1 (electrically isolated) From USB 1.1 Remove CompactFlash Card, read in through CompactFlash Card reader Wireless module 2400 MHz to MHz Sensitivity level 0 dbm mean (Class 2) Hopping frequency Guard band Battery type Voltage Capacity Overvoltage 2400 to MHz, F=2402+k MHz, k= MHz < F < 3.5 MHz, in USA, Japan, Europe Power pack Li Ion 3.7 V 2.15 Ah 4.35 V Max. charging current 1 A Normal discharge current <1 A Temperature range 20 to +85 Charging cycles 500 Charging time with device switched off approx. 3 h at 25 C for empty power pack * Observe also temperature range of respiratory flow snore sensor (see Page 21). Technical data 79

84 Position sensor Range of values Position sensor Sensor integrated in device left side, right side, front, back, standing Position accuracy approx. 45 ± 15 CPAP / BiPAP / SmartPAP pressure Measurement range Accuracy 0 to 40 hpa ±1 hpa Flow differential pressure Pneumo-T-adapter Cone, standard ISO 22 Sensor Thorax sensor Method Differential pressure: Inhalation/exhalation pressure fluctuations Effort sensors (thorax, abdomen) Sensor integrated in device Piezoelectric measurement Respiratory flow snore sensor Respiratory flow nasal cannula Respiratory flow mouth sensor Respiratory flow 3 thermistors as summation signal, no measuring function at temperatures between C Inhalation/exhalation pressure fluctuations One thermistor, no measuring function at temperatures between C We reserve the right to make design changes. Respiratory flow snore sensor Respiratory flow nasal cannula Pneumo-T-adapter Method Shockproof plug-in connectors, DIN Snoring Integrated microphone Pressure sensor Pressure sensor Logarithmic mean of sound pressure signal (microphone) or pressure fluctuations (pressure sensor) Electrodes 1.5 mm 80 Technical data

85 Parameter Pulsoximeter clip sensor Value range Min. Max. Unit Sensor: wavelengths nm Sensor: heat output 0 20 mw Signal quality % SpO 2 measurement: SpO 2 measuring range % Measuring dynamics First reaction after Final value reached after 2 8 First display after attachment 3 6 s Pulse frequency measurement: Pulse frequency measuring range Measuring dynamics First reaction after Final value reached after s s Precision/Comment Maximum temperature increase by 2 C at attachment site Signal quality 90 % is good, SpO 2 values and pulse frequency may be unreliable below this. 70 % < SpO 2 < 100 %: better than 2 % accuracy SpO 2 < 70 % not validated Measured at desaturation/resaturation between 96 % and 84 % SpO 2 under favourable measuring conditions. The values may become longer in the event of low pulsation strength/ movement artefacts. Measured with default setting. The poorer measuring conditions are, the more unreliable the first value displayed will be Bpm 1 Bpm to 2 % of display value First display after attachment 5 8 s s s Maximum values were measured at a sudden change from 40 to 200 Bpm and vice versa. The times for reaction and final value depend on the difference (deviation) of beats from one another. Measured with default setting. The poorer measuring conditions are, the more unreliable the first value displayed will be. Technical data 81

86 Electrophysiological signals in the basic device ExG channels ECG EEG EMG EOG Dynamic range (range of physical values) ± 5mV ±500 µv ±250µV ±500µV Resolution 12 bit 12 bit 12 bit 12 bit Precision of amplitude ± 3 % ± 3 % ± 3 % ± 3 % Precision of frequency range Frequency range in the hardware High-pass filter in the device software ± 15 % ± 15 % ± 15 % ± 15 % 0.2 Hz 100 Hz 0.2 Hz 100 Hz 0.2 Hz 100 Hz 0.2 Hz 100 Hz 0.02 Hz 0.5 Hz 2.7 Hz 0.5 Hz Scanning rate 256 Hz 256 Hz 256 Hz 256 Hz The following can be configured Specification Input impedance ECG, EEG, EMG, EOG as for EMG, EOG, EEG, ECG approx. 40 MΩ Electrophysiological signals in the basic device at the R&K and ECG master cables ExG-Kanäle EEG EOG EKG Dynamic range (range of physical values) ±500 µv ±500 µv ±500 µv Resolution 12 Bit 12 Bit 12 Bit Precision of amplitude ± 3 % ± 3 % ± 3 % Precision of frequency range ± 15 % ± 15 % ± 15 % Frequency range in the hardware 0.2 Hz 70 Hz 0.2 Hz 70 Hz 0.05 Hz 100 Hz High-pass filter in the device software 0.5 Hz 0.5 Hz 0.02 Hz Scanning rate 256 Hz 256 Hz 256 Hz Input impedance ca. 40 MΩ Note: These channels have fixed configurations 82 Technical data

87 Signals and scanning rates No. Name Source 1 Flow I Nasal cannula/pneumo- T-adapter Scanning rate in Hz Recommended filters and scales for visualization High-pass filter Lowpass filter Block ECG - in the event of a poor signal, deactivate block and reduce low-pass filter to 35 Hz, 30 Hz, 20 Hz until signal improves. EEG - if high-frequency signals are essential (spikes up to 30 Hz): high-pass filter 35 Hz, caution: signal becomes less clear. EEG - deactivate "Truncate signals at the channel limits" option if possible. Otherwise: scale from -150 to 150. EEG -75 µv line: activate only if required frequently: contrast is reduced. from Scale 32 None 5 Hz None Flow II Flow/snore sensor Hz 1 Hz None Effort thorax Thorax belt piezo Hz 0.8 Hz None Effort abdomen Abdomen belt piezo Hz 0.8 Hz None Snoring Nasal cannula/flow/ snore sensor 16 None None None Flattening Pneumo-T-adapter 8 None None None Saturation Finger sensor 16 None None None Pulse PF Finger sensor 16 None None None Pulse HF ECG 16 None None None Pressure Pneumo-T-adapter 32 None None None Leakage Pneumo-T-adapter 8 None None None Position 13 Respiratory frequency Position sensor, integrated Nasal cannula/pneumo- T-adapter 16 None None None 8 None None None Quality Finger sensor 10 None None None None None 15 Plethysmogram Finger sensor 50 None None None None None 16 EMG Electrodes Hz 70 Hz 50 Hz ECG Electrodes Hz 70 Hz 50 Hz EEG Electrodes Hz 20 Hz None EOG Electrodes Hz 30 Hz None to Technical data 83

88 13.1 Safe distances Recommended safe distances between portable or mobile HF telecommunication devices (e.g. mobile phones) and the SOMNOcheck 2 (2 R&K) Rated output of HF device in W Safe distance in m depending on transmission frequency 150 khz - 80 MHz 80 MHz 800 MHz 800 MHz 2.5 GHz Technical data of non-medical components Observe the operating instructions supplied with the individual components. 84 Technical data

89 14. Warranty WEINMANN guarantees that the product, when used in accordance with requirements, will remain free from defects for a period of two years from date of purchase. For products whose durability is clearly indicated as less than two years, the warranty runs out on the expiration date indicated on the packaging or in the user s manual. Claims against the warranty can be made only when accompanied by the sales receipt, which must show salesperson and date of purchase. We offer no warranty in the case of: Disregard of usage instructions Operating errors Improper use or handling Third-party intervention by non-authorized persons for the purpose of device repair Acts of God, e.g., lightning strikes Transport damage as a result of improper packaging of returned items Lack of maintenance Operational and normal wear and tear, which includes, for example, the following components: Disposable articles All sensors, such as Respiratory flow / snore sensor Respiratory flow mouth sensor Electrode set etc. Failure to use original spare parts WEINMANN is not liable for consequential harm caused by a defect if it is based on intention or gross negligence. WEINMANN is also not liable for minor physical injury to life or limb resulting from negligence. WEINMANN reserves the right to decide whether to eliminate defects, to deliver a defect-free item or to reduce the purchase price by a reasonable amount. Warranty 85

90 If WEINMANN rejects a claim against the warranty, it assumes no expense for transport between customer and manufacturer. Implied warranty claims remain unaffected by these changes. Send devices to be repaired complete with all accessories to: WEINMANN Kundendienst Service Geräte für Medizin GmbH+Co. KG Siebenstücken 14 D Henstedt-Ulzburg Germany If you have any questions or problems contact your local dealer or send an to: somnocheck.hotline@weinmann.de 15. Declaration of Conformity WEINMANN Geräte für Medizin GmbH + Co. KG declares herewith that the product complies fully with the respective regulations of the Medical Device Directive 93/42/EEC. The unabridged text of the Declaration of Conformity can be found on our website at 86 Declaration of Conformity

91

92 Weinmann Geräte für Medizin GmbH+Co.KG Postfach D Hamburg Kronsaalsweg 40 D Hamburg T: +49-(0) F: +49-(0) E: Center for Production, Logistics, Service Weinmann Geräte für Medizin GmbH+Co.KG Siebenstücken 14 D Henstedt-Ulzburg T: +49-(0) F: +49-(0) WM 96206e