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SOMNOlab 2 - Kshema Medical

1. 58 Operation Notes the LEDs on the device do not indicate which of the individual electrodes has poor impedance In this case call up the values for the individual electrodes via the SOMNO ab software in order to establish the faulty electrode Once the electrodes sensors have been attached successfully the relevant LED on SOMNOlab 2 goes out The state of the LEDs on SOMNO ab 2 does not then change again when the sensor test is ended in the next step by closing the impedance window in the software In the sensor test all channels including effort and pulsoximetry sensors as well as oral thermistor and nasal cannula are checked 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 through all the configured channels once and then displays its result until the window is closed or a new test is started e Correct recording and performance of automatic analysis is possible only at a low impedance value For optimum signal quality we recommend aiming for a completely non illuminated LED for all channels e For an application check on the PC screen observe the plausibility of the signals If a signal is not displayed check device and display configurations If both are present and you still receive no signal this is an indication that the sensor is defective Operation 59 5 3 Start and end of measurement
2. Never open the device SOMNOlab 2 must be attached firmly but comfortably to the body so that body position is recorded correctly The effort sensors must always be taut so that respiratory movements are recorded as well as possible The cable of the pulsoximetry sensor should be secured on the patient s finger or hand with a plaster for example This stops the cable being a nuisance and prevents the sensor from slipping out of position The patient should sleep with the window closed and alone if appropriate in order to prevent measuring results being falsified by unrelated noises The sensors must be clean and dry Contamination such as secretions following sneezing should be wiped off carefully You can draw the cable of the pulsoximetry sensor through the sleeve of your patient s pajama top before attaching the sensor to his finger The patient should avoid pulling the blankets or pillow over his or her head This would significantly increase ambient temperature Operation 61 resulting in the respiratory flow snore sensor delivering faulty measurement data The fingernail of the index finger to which the pulsoximetry sensor is attached may not be painted with colored nail varnish A measurement will likewise give incorrect results if itis performed on fingers with false nails made of acrylic If the pulsoximetry sensor is pinching the patient can attach the sensor to a different
3. Network USB server This USB server enables you to operate SOMNO ab 2 through a network This is required in many sleep laboratories if the patient s room is at a distance from the recording room You can likewise connect SOMNOlab 2 by cable via the USB PC electrical isolation module Note that the network USB server has to be installed outside the patient s environment Card reader unit for CompactFlash cards The card reader unit for the CompactFlash card enables you to read out SOMNOlab 2 data stored on the CompactFlash card You can also configure SOMNOlab 2 via the card reader unit for the CompactFlash card and set up several CompactFlash cards of different configurations for yourself 22 Description 1 3 Signals and messages In order for you to be able to be sure at all times that measurement is proceeding smoothly SOMNOlab 2 has visual signals These take the form of light emitting diodes LEDs Light emitting diode State Meaning LEDs on the memory card Illuminated bright green Device is switched on Flashing slowly green 1x per sec Wireless connection created not on the SOMNO ab 2 effort Flashing 10x green 2x per sec Start of recording Flashing rapidly green 4x per sec Device being configured or stored measurement transfer ring to PC Illuminated yellow No memory card in device Flashing yellow 2x per sec Me
4. The device is not intended for use on people weighing less than 20 kg SOMNOlab 2 may not be used on the open heart The system generates information signals These are for checking the presence of signals for recording and to check the function of the device Alarms are not generated The PC on which the data are stored and visualized its peripherals e g printer or non medical devices may not be placed in the immediate vicinity of the patient within 1 5m Additional equipment connected to the analog and digital ports of the device must have evidence of conformity with the corresponding EN specifications e g EN 60950 for data processing devices and EN 60601 for electrical medical devices Furthermore all configurations must comply with the version of system standard 34 Safety instructions EN 60601 1 applicable at the time of sale Anyone connecting additional devices to the signal input or output part is considered a system configurer and is thus responsible for compliance with the applicable version of standard EN 60601 1 In the event of questions contact your local specialist dealer or Weinmann Customer Service Follow the instructions for use and the short form instructions for use of existing older system components which you want to use with SOMNOlab 2 SOMNOlab 2 may only be used by trained professionals with adequate factual knowledge who have received instruction If third party items are used
5. effort basic devices The basic devices have the following intended use record the following sleep related parameters e 4 freely configurable electrophysiological channels E G1 E G4 which can optionally be set for EMG EOG EEG and ECG parameters with the corresponding electrodes does not apply to SOMNO lab 2 effort e thorax and abdomen movements e oxygen saturation SpO by pulsoximetry e pulse frequency by pulsoximetry e nasal respiratory flow e oral and nasal respiratory flow e oral respiration e snoring e patient position e xPAP pressure e heart frequency does not apply to SOMNOlab 2 effort e pulse wave e quality index of oxygen saturation e 1 ECG channel only using the appropriate PSG R amp K or PSG AASM master cable Description 15 e 5 ExG channels only using the appropriate PSG R amp K or PSG AASM master cable SOMNOlab 2 processes and stores all measured signals on the integrated CompactFlash card The data are read out either via USB cable or by reading out the CompactFlash card using a card reader unit When used in fixed mode SOMNO ab 2 can transfer the recorded data online either wirelessly or by cable to the SOMNOlJab software which also saves the data Online transmission of data is not possible with the SOMNOlab 2 effort Existing hospital networks may be used for online monitoring with the aid of SOMNO ab 2 If data are lost for example when leavin
6. functional failures may occur and fitness for use may be restricted Biocompatibility requirements may also not be met Please note that in such cases any claim under warranty and liability will be voided if neither the accessories nor genuine replacement parts recommended in the instructions for use are used SOMNOlab 2 components may not be immersed in liquids Ingress of liquid into the device during operation and storage reduces the functional capability and safety of the device The battery may not be immersed in liquids either Gas may evolve and the battery may split Replace all parts which are damaged worn or contaminated before using the device Only the manufacturer or informed staff may open the device and carry out repairs or servicing work Any claim under warranty is voided if the device is opened without authorization Safety instructions 35 Operate the device only in conjunction with the original Weinmann power supply unit Do not operate any devices which produce electromagnetic fields in the vicinity of SOMNOlab 2 Faults or measuring errors may be caused by the following devices for example interference with an electrical surgical unit X rays MRI devices radio signals radio telephones cellphones power lines electrical stimulation devices Do not operate SOMNO ab 2 with devices which supply the body with energy such as electrostimulation devices for example
7. or PSG AASM Perform an impedance measurement of the electrodes as a function check before each recording Do not connect any electrodes in parallel to other systems The function of SOMNO ab 2 is then no longer guaranteed Ensure that the electrodes are correctly connected otherwise you will get false analysis results and signal displays Do not connect any third party devices with 1 5 mm connectors to SOMNOlab 2 Operation 45 Notes Affix gold cup electrodes 1 Clean the desired skin location with physiological saline NaCl 0 9 or alcohol A cotton wool ball and or gauze swab is highly suitable Then roughen the skin with a skin preparation paste Rub a little conductive paste into the skin using a finger this promotes conductivity and provides a good surface for the electrode to adhere to Then put a pea to bean sized piece of conductive paste into the depression in the electrode and press the electrode firmly to the skin so that the paste is squeezed out from under the edges Place a piece of gauze over the electrode and the escaped paste and press on again Ensure that the edge of the electrode is firmly attached to the skin sealing off the conductive surface This will prevent the paste in the electrode losing conductivity as a result of drying out Also fix the cable of the electrode with a plaster This relieves tension and ensures reliable recording overnight With the EMGs you can also
8. 0 256 snore sensor 6 Flattening Pneumo T adapter 8 None None None 0 100 7 Saturation Finger sensor 16 one None None 70 100 8 Pulse PF Finger sensor 16 None one None 50 20 9 Pulse HF ECG 16 one None one 50 120 O Pressure Pneumo T adapter 32 one None one 4 18 1 Leakage Pneumo T adapter 8 one None one 00 2 Position Position es 16 one None one ntegrated Respiratory asal cannula 3 8 one None one 0 20 requency Pneumo T adapter 4 Quality Finger sensor 10 one None one None None 5 Plethysmogram Finger sensor 50 one None one None None 6 EMG Electrodes 256 10Hz 70Hz 50Hz 100 100 7 EKG Electrodes 256 0 1 Hz 70 Hz 50 Hz 1500 2500 8 EEG Electrodes 256 0 5Hz 20Hz None 80 80 9 EoG Electrodes 256 0 5Hz 30Hz None 120 120 1 not on the SOMNO ab 2 effort Technical data 89 13 1 Safety distances Electrical medical devices require special precautionary measures as regards electromagnetic compatibility EMC They must be installed and put into operation in accordance with the EMC instructions contained in the accompanying documentation Recommended safety distances between portable and mobile HF telecommunication devices e g cellphones and SOMNOl ab 2 eae Safety distance depending on transmission frequency in m 150 KHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 35 0 35 0 70 10 1
9. 10 See above together with 1 connection for Overview 5 Sensors 17 Respiratory flow snore sensor 18 Sensor beads 19 Sleeve 20 Microphone NO lt S8 21 Carrier plate 23 Respiratory flow nasal cannula 28 Respiratory flow oral sensor 4P 24 Sleeve 25 Cannulas 26 Saddle 22 Sensor connector ALT 29 Master cable 30 3 pin ECG master cable 34 Pneumo only with only with PSG R amp K T adapte PSG R amp K or or PSG AASM PSG AASM co 27 Connection 32 Pulsoximetry 33 Abdomen r sensor PC elements 35 Power 34 CD ROM supply unit 38 Charging data transfer cable 44 CompactFlash ecard 39 USB cable eed 36 Power supply unit 37 Connector 40 USB PC electrical isolation module 41 Connection for charging data transfer cable 42 USB connection 43 Connection for power supply unit Belts 45 Attachment belt with connecting strap 46 Abdominal belt with connecting strap 6 Overview Examples of use bar 5 Overview 7 Potential markings on application parts General markings on the application parts Symbol Meaning Date of manufacture Follow instructions for use CE symbol confirms that the product conforms to the applicable European directives m gt BE N Type BF application part Do not dispose of
10. 11 1 11 2 21 100 3 50 3 50 7 00 Further technical details can be obtained from the manufacturer Weinmann on request 13 2 Technical data for non medical components Please observe the instructions for use for the individual components enclosed with your delivery 90 Technical data 14 Warranty Weinmann gives the customer a limited manufacturer warranty on new genuine Weinmann products and any replacement part fitted by Weinmann in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below The warranty conditions can be downloaded from www weinmann de on the Internet We can also send you the warranty conditions on request In the event of a claim under warranty contact your specialist dealer Product Warranty period Weinmann devices including accessories except masks for sleep diagnosis sleep therapy home ventilation oxygen medicine and emergency medicine 2 years Masks including accessories rechargeable battery batteries unless there is information to the contrary in the 6 months technical documentation sensors tube systems Disposable products None Warranty 91 15 Declaration of conformity Weinmann Ger te f r Medizin GmbH Co KG hereby declares that the product complies with the relevant provisions of directive 93 42 EEC pertaining to m
11. Do not dispose of the device with domestic waste To dispose of the device properly contact an approved certified electronics scrap dealer You can obtain the address from your Environment Officer or your local authority Disposal 79 12 Scope of supply replacement parts accessories 1 SOMNOlab 2 effort polygraphy system WM 95480 2 SOMNOlab 2 PG expanded polygraphy system WM 95420 3 SOMNOlab 2 PSG R amp K polysomnography system WM 95400 4 SOMNOlab 2 PSG AASM polysomnography system WM 95260 5 SOMNOlab 2 complete package WM 95050 S scope of supply R replacement part 80 Scope of supply replacement parts accessories 12 1 Basic devices Order no Article bk en am Wm WM 95420 95400 95260 95050 95480 WM 95410 SOMNOlab 2 basic device SIR S R S R S R WM 95481 SOMNOlab 2 effort basic device SIR S R WM 95115 Power pack with capacity monitoring SIR S R S R S R S R WM 95155 Loop abdomen sensor SIR S R S R S R S R WM 94053 Attachment belt 1 10 m long yellow S R SIR SIR SIR SIR buckle WM 94054 Attachment belt 1 5 m long green buckle SIR SIR S R S R S R WM 94082 Abdominal belt 1 5 m long green buckle SIR SIR S R SIR S R WM 94083 Abdominal belt 1 10 m long yellow buckle SIR S R S R SIR S R WM 95151 2x connecting strap with 40 mm closure SIR
12. Keep the battery away from heat naked flame and corrosive liquids e Before a defibrillator is used all parts of the system on the patient must be removed completely e SOMNOlab 2 may not be operated in an atmosphere at risk of explosion e When SOMNOlab 2 is connected to the electricity supply via other devices e g via the electrical isolation module do not operate SOMNOlab 2 during a thunderstorm if there is any risk at all to the device or the patient e Before cleaning SOMNOlab 2 disconnect the power supply plug the battery and all the power supply plugs of devices connected to SOMNOlab 2 e Do not connect the device to the electricity supply with the aid of electrode cables or connectors Safety instructions 33 Caution Do not touch the patient if you are simultaneously holding the connector for the power supply unit and the power supply unit is still connected to the power supply socket The device must not be modified If you modify the device you are considered a system configurer and are therefore responsible for compliance with the applicable version of standard EN 60601 1 In the event of questions contact your local specialist dealer or Weinmann Customer Service Do not touch the patient if you are in contact with electrically conductive parts of other devices that are not application parts Do not short circuit the battery The system may not be used to monitor vital physical functions
13. O1 A2 M2 C3 A2 M2 and F3 A2 M2 48 Operation Ir PN u In IITA D D ee Position EOG electrodes SOMNOlab 2 has two channels for recording eye movements Position one electrode approx 1 cm above and somewhat to the side of the edge of the right eye The reference electrode is located on the mastoid or earlobe on the same side Affix the second electrode approx 1 cm below 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 the EOG signals in counterphase in both REM sleep and when awake Artifacts and EEG signals are shown in parallel phase with this arrangement Electromyogram EMG The EMG registers muscle activity 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 to distinguish the different stages of sleep The EMG of the legs is specifically for diagnosing restless legs syndrome RLS and periodic leg movement in sleep syndrome PLMS Operation 49 5 2 Put on SOMNOlab 2 device and sensors Notes Note e Ensure that all belts sensors and cables are attached to the patient so that they cannot cause any chafing or restrict breathing Your patient must still be able to breathe freely e It is essential to charge the
14. Precautions e Ensure that your battery is fully recharged following a prolonged measurement 64 Handling the battery SOMNOlab 2 batteries can be recharged at any time There is no memory effect Even fully charging in several stages with or without interim partial discharge will not cause any harm The battery of SOMNO ab 2 should not become fully discharged in normal daily use so do not operate SOMNO ab 2 until it switches off automatically Although discharging it completely will not directly reduce its capacity the number of possible charging cycles drops dramatically This will reduce service life if the battery is used frequently To care for the SOMNO ab 2 battery you should discharge the battery completely every 4 6 months and then recharge it SOMNOlab 2 has an intelligent battery The power pack includes electronics which are able among other things to determine capacity so as to calculate the running time displayed To perform a full discharge configure a 12 hour measurement without charging the battery beforehand This battery will not tolerate deep discharge This can be caused for example if the battery is stored for several months without being recharged from time to time Cell oxidation continuously reduces battery capacity This process is accelerated at elevated temperatures and a state of greater discharge The natural discharge of a lithium ion battery as a result of internal chemical proce
15. With regard to electrical safety PC systems are not part of the SOMNO ab 2 application part due to the application part being electrically isolated from the PC system The PC system used must satisfy the terms of EN 60950 The PC software is for visualizing evaluating documenting and archiving long term investigations for the diagnosis of sleep disorders on a patient specific basis The system is configured for this and the data transferred are analyzed automatically offline The PC software allows the user to enter comments The evaluator can reclassify analysis results manually The system is designed for people weighing 20 kg or more using the sensors specified by Weinmann Professionals prepare the measurement operate the SOMNOlab PC software and charge the battery The EEG electrodes for the master cable are attached to the patient and connected to the system by professionals only with PSG R amp K or PSG AASM Following instruction by professionals and using the instructions for use for patients the patient is in a position to attach the remaining sensors and the device him or herself Description 13 Note SOMNOlab 2 has been tes ted only with Artisana sleep stage and arousal analysis Options Four models of the SOMNO ab 2 are available e SOMNOlab 2 effort e SOMNOlab 2 PG e SOMNOlab 2 PSG R amp K e SOMNOlab 2 PSG AASM The scope of supply for the SOMNO lab 2 effort and SOMNOlab 2 PG po
16. cycles An incomplete discharge charge cycle also counts as a charge cycle 66 Handling the battery 6 3 Storage 6 4 Battery disposal If the battery is not charged service life is 1 year Protect the battery from heat If the battery is stored at temperatures of over 60 C for a prolonged period in direct sunlight in a car for example it will lose capacity permanently Replace the battery once its service life is over You can remove the battery by pressing latch 7 and taking the battery out of the bracket Insert battery push the battery into SOMNO ab 2 until it engages with an audible click Batteries should be stored at 50 charge and room temperature Lithium ion batteries age significantly at full charge and a high storage temperature Do not dispose of the battery in domestic waste To dispose of the battery properly contact an approved certified electronics scrap dealer You can obtain the address from your Environment Officer or your local authority Handling the battery 67 7 Hygiene treatment Note This product may contain disposable items Disposable items are intended to be used only once So use these items only once and do not reprocess them Reprocessing disposable items may impair the functionality and safety of the product and lead to unforeseeable reactions as a result of ageing embrittlement wear thermal load the effects of chemical processes etc
17. device for easier handling Perform a sensor test not on the SOMNOlab 2 effort Perform a test once the sensors and devices have been attached to reassure yourself and your patient that all the sensors are properly connected e Start the sensor test impedance measurement by pressing key 6 on SOMNO ab 2 twice in quick succession or by calling up the impedance measurement on the PC e You should also follow the instructions in the section entitled 1 3 Signals and messages on Page 23 Method Device Sensor test running During the sensor test the LED of the sen sor just being tested flashes rapidly 4x a second Sensor test OK The LED of the corresponding signal stops flashing once the impedance test is com plete impedance of the electrode lt 5 kQ OK or sensor signal present Sensor test accept able The LED of the corresponding signal flashes slowly once the impedance test is complete impedance of the electrode lt 10 KQ not ideal but acceptable quality Green LEDs flash slowly 1x in 2 seconds Sensor test not OK The LED of the corresponding signal flashes rapidly once the impedance test is com plete impedance of the electrode gt 10 kQ or no sensor signal check electrode sensor unac ceptable signal quality Green LEDs flash rapidly 1x per second If poor impedance gt 10 ka is measured for the R amp K or AASM master cable and the ECG master cable
18. doctor instructed by the medical devices consultant and by professionals Description 11 instructed by the doctor or by a patient who has received instruction As an option SOMNOlab 2 can be expanded into a polysomnography device does not apply to SOMNOlab 2 effort There is no monitoring of emergency or intensive care patients The system does not generate alarms SOMNOlab 2 SOMNOlab 2 effort is made up of the components below basic device sensors application parts Liion battery medically licensed power supply unit with USB charging cable to charge the battery and to transfer the stored data to a PC via an elec trically isolated USB port 1 2 Description of function General information about the SOMNOlab 2 e SOMNOlab 2 generates information signals e g status of battery charge which are visualized in graphical form and saved by the PC system These information signals are for checking the presence of signals for recording and for checking the function of the device This avoids faulty recordings and the repeat night measurement which would otherwise be required e The system does not generate alarms 12 Description The automatic analyses PLM snoring sleep stage arousal and cardiorespiratory analysis are performed offline in the PC from the signals stored and support the person making the evaluation in diagnosing sleep disorders and in introducing and checking therapy
19. if there is communication with the PC or the battery is being charged 40 Installation Note The PC system must be switched off when the USB PC electrical isolation mod ule is connected up Note The connector of the charg ing data transfer cable is equipped with a latching mechanism to prevent the cable being pulled out in advertently To remove the cable from the USB PC elec trical isolation module again first push the outer sleeve of the connector backwards in order subse quently to be able to pull out the connector Plug USB cable 39 into connection 42 marked on the USB PC electrical isolation module the other end into a free USB port on the PC If you have several SOMNOlab 2 systems ensure correct assignment to the individual devices Plug connector 37 of the power supply unit into connection 43 marked B on the USB PC electrical isolation module Plug one end of the charging data transfer cable into connection 8 on the battery the other end into connection 41 marked A on the USB PC electrical isolation module Plug the connector of the power supply unit into a power supply socket Save yourself work Leave the power supply unit permanently plugged into a power supply socket and the USB cable connector plugged into your PC This means the connector for SOMNOlab 2 is always handy on your desk The system is now operational Connect network USB server to PC for commun
20. in addition In this case it is also important to follow the instructions for use for the exhalation system 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 measurement tube of the therapy device should not pass through the Pneumo T adapter Operation 55 Important otherwise you will obtain inaccurate measurements 4 Push the ends of the double tube onto the connecting stubs of the Pneumo T adapter as follows the tube marked red onto connection A of the adapter likewise marked red the other tube onto connection B 5 Screw the tube plugged onto the connection nearer to the breathing mask marked red of the adapter to pressure connection A on the device 6 The other tube is accordingly screwed onto the other pressure connection Ensure that the pressure measurement tubes are correctly connected on the Pneumo T adapter and the device If the tubes are confused inspiration and exhalation will be shown the wrong way round in the recording Connection A of the Pneumo T adapter which points towards the mask must always be connected to A on the device otherwise the respiration phases will be shown incorrectly in the software Attach pulsoximetry sensor e Use the pulsoximetry sensor only in combination with SOMNOlab 2 e If
21. see Page 28 Technical data 85 Radio module not on the SOMNOlab 2 effort CPAP BiPAP SmartPAP pressure Carrier frequency band 2400 MHz to 2483 5 MHz Measuring range O hPa to 40 hPa Type and frequency response of modulation GFSK 1 Mbps 0 5 BT Gaussian Precision 1 hPa Respiratory flow Frequency hopping 1600 hops s 1 MHz channel spacing Skip frequency 2400 MHz to 2483 5 MHz F 2402 k MHz k 0to 78 Respiratory flow snore sensor 3 thermistors as summation signal no measuring func ion at ambient tempera ures between 33 C to 38 C Transmission power Typical 0 dBm Class 2 Respiratory flow nasal cannula Pressure fluctuations on inspiration exhalation Receiving signal range Typical 80 dBm to 15 dBm Receiver DC link frequency 1 5 MHz heterodyne down converter Respiratory flow oral sensor One thermistor no measur ing function at ambient emperatures between 33 C to 38 C Protective area 2 MHz lt F lt 3 5 MHz for USA Japan and Europe except Spain and France Differential flow pressure Pneumo T adapter Tapered connector to ISO 22 standard Battery Differential pressure pres Type of battery Li ion Sensor sure fluctuations on inspira Voltage TN tion exhalation Capacity 2 2 Ah Effort sensors thorax abdomen Overvoltage 4 35 V Thor
22. sensor detects respiration movements of the abdomen The sensor is made of a skin friendly synthetic material EXG electrodes not on the SOMNO ab 2 effort The variable recorded by the electrodes is voltage The difference in voltage between two points of the body is measured As the measurement is performed non invasively on the surface of the skin measurable differences in voltage are very small They are in the UV range for EEG EOG and EMG and in the mV range for ECG A key factor in the quality of the measurement is the electrical resistance between the skin the electrode and the gap between the two Transitional resistance can be reduced by careful cleaning removal of grease and slight roughening of the skin as well as by the use of electrode gel The reference electrode Z electrode plays a key role in the leads It ensures there is a common reference potential for the electronics 32 Description 2 Safety instructions Read these instructions for use through carefully They are a constituent part of the device and must be available at all times Use the device only for the intended use described see 1 1 Intended use on page 11 For your own safety and that of your patients and in accordance with the requirements of directive 93 42 EEC observe the following instructions SOMNOlab 2 and application parts Warning The battery may not be damaged crushed opened or taken out of its case e
23. software Scanning rate 256 Hz 256 Hz 256 Hz 256 Hz The following can be configured ECG EEG EMG EOG Specification as for ECG EEG EMG EOG Input impedance approx 40 MQ Electrophysiological signals in the basic device on R amp K or AASM master cable and ECG master cable not on the SOMNOlab 2 effort EXG channels EEG EOG ECG Dynamic range physical value range 500 uV 500 uV 500 uV Resolution 12 bits 12 bits 12 bits Amplitude precision 3 3 3 Frequency range precision 15 15 15 Frequency range in the hardware 0 05 Hz 0 05 Hz 0 05 Hz High pass filter in device software 0 5 Hz 0 5 Hz 0 02 Hz Scanning rate 256 Hz 256 Hz 256 Hz nput impedance approx 40 MQ Note These channels are permanently configured 88 Technical data F Recommended filters and scales for Signals and scanning rates SIA visualization Scanning High pass Low Lock Scale NO Same Source rate in Hz filter pass out filter from to 1 Flow asal caninula 32 None 5 Hz None 128 128 Pneumo T adapter 2 Flow Il Flow snore sensor 32 0 1 Hz 1 Hz None 128 28 3 Effort thorax Thorax belt piezo 32 0 05Hz 0 8 Hz None 128 128 4 Effort abdomen Abdominal belt piezo 32 0 05 Hz 0 8 Hz None 128 128 5 Snoring Nasal San nu 16 one None one
24. the device is correctly connected to the PC using the appropriate charging data transfer cables and the card reader unit for the CompactFlash card Start the SOMNO ab PC software Select the appropriate type of data transfer and start a measurement Perform this test using the charging data transfer cable the wireless module and if present the network USB server Configure the device using the card reader unit for CompactFlash cards Perform a brief recording and read out the card again Check communication between the components of SOMNO ab 2 and the PC system by triggering the sensor test and the impedance measurement and testing the function of the sensors Observe the plausibility of the signals Function check 73 You can put SOMNOlJab 2 on yourself to test the function of sensors or of the device e This function check is not a substitute for the checks on the device which are performed in the course of servicing 74 Function check 9 Troubleshooting 9 1 SOMNO ab 2 SOMNOlab 2 effort basic devices Note the scope of function for your SOMNO ab 2 when troubleshooting Fault Cause of fault Remedy No signal in flow snore effort and or pulsoximetry channel The respiratory flow snore sen sor and or the pulsoximetry sensor are not attached Put on the missing sensor ug connections are not roperly connected Ensure the connections are firm P p The sensors are dirty da
25. the device with domestic waste Special markings on SOMNOlab 2 Symbol Meaning IPX O No protection against ingress of water SN Xxxx Serial number 1 8 Z Free electrophysiological inputs not on the SOMNO ab 2 effort A B Pressure connections Battery Label to differentiate between polysomnography devices with PSG R amp K or PSG AASM and polygraphy devices without options can be affixed to the polysomnography device if required Label to distinguish between the SOMNO ab 2 PG and SOMNOlab 2 effort polygraphy devices 8 Overview Meaning Application locations for sensors HF transmitter not on the SOMNO ab 2 effort Follow instructions for use Special markings on the USB PC electrical isolation module Symbol Meaning aoe Electricity supply direct current connection for power supply unit con me verter box A SOMNOlab 2 connection USB PC electrical isolation module B Power supply unit connection USB PC electrical isolation module C PC connection USB PC electrical isolation module Special markings on the power supply unit Symbol Meaning Protection class Il Input Output Only for use indoors Overview 9 Special markings on the packaging Symbol Meaning amp Intended to be used once and then disposed of P fy 0 95 Humidity in operation transport an
26. use disposable electrodes To do so clean the skin as for gold cup electrodes and also fix the electrodes with plasters Apply the electrodes very carefully The quality of the measurement depends on a good adhesion point as the transition point between the skin and the electrode is highly susceptible to faults Poorly affixed electrodes increase artifacts making the recording harder to assess Clean the electrodes with alcohol or saline before every measurement 46 Operation e Follow the instructions for use for the adhesive electrodes gels and pastes with regard to skin tolerance and allergies to the materials used e Observe the shelf life of the gels pastes and electrodes used Positioning the leg EMG The leg EMG is recorded on a bipolar basis The first lead point is 4 finger widths below the attachment of the patellar ligament and one finger width lateral of the proximal margin of tibia the second point is 5 cm distal of this You can also use disposable electrodes for the leg EMG To do so clean the skin as for the gold cup electrodes Fix the electrode cable with plasters in several places This will prevent the cable dropping off as a result of the patient s movements Positioning the ECG Like EMGs the ECG is also recorded on a bipolar basis The polysomnography lead of SOMNO ab 2 is analogous to the Einthoven lead To this end affix the negative electrode marked red to the ste
27. For cleaning and disinfecting follow the recommendations of the Kommission f r Krankenhaus Hygiene und Infektionspr vention Commission for Hospitals Hygiene and the Prevention of Infection of the Robert Koch Institut RKI and of the BfArM Bundesinstitut f r Arzneimittel und Medizinprodukte Federal Institute for Pharmaceuticals and Medical Devices regarding hygiene requirements when treating medical devices Bundesgesundheitsblatt Federal Health Gazette 44 2001 For hygiene treatment of the accessories see the instructions for use in question 68 Hygiene treatment 7 1 Intervals Part When Clean Disinfect 5 5 2 Yv v i gt v TESE aE ME I EI ae ee ven SE He a ae ee Mae z 2 2 2 kA amp ja S a y 5 a 5 lt O Y S a a a SOMNOlab 2 SOMNOlab 2 effort basic 5 devices Pneumo T adapter Pulsoximetry sensor follow instructions for use Respiratory flow snore sensor Respiratory flow oral sensor Abdomen sensor Press stud electrodes gold cup electrodes and electrode cables see note enclosed in pack Bags and belts Charging data transfer cable R amp K or AASM master cable ECG master cable ECG master cable extension Battery Respiratory flow nasal cannula Disposable item Adhesive electrodes from the electrode set Disposable
28. S R S R S R S R WM 94055 _ Carrying bag S R S R S R S R S R WM 98500 SOMNOlab PC software S R S R S R S R SIR WM 95090 Power supply unit S R S R S R S R S R WM 95116 Charging data transfer cable SIR S R S R S R S R WM 95091 USB PC electrical isolation module SIR S R S R S R SIR WM 96501 Set electrodes S R S R S R S R WM 96502 Set removable cards SIR S R S R S R WM 95093 Removable card for Application 1 SIR WM 95083 Pneumo T adapter incl 5 tubes SIR S R S R S R R WM 95235 R amp K upgrade set consisting of S R R WM 95206 R amp K master cable R R WM 95207 3 pin ECG master cable R R WM 95421 ECG master cable extension R R WM 95252 master cable bracket 3 R R 2 WM 95233 set of electrodes for SOMNOlab 2 R R polysomnography device WM 95097 removable card for Application 5 R amp K R R WM 95237 upgrade symbol for polysomnography R R device Scope of supply replacement parts accessories 81 Order no Article aM WM wm wm wm i 95420 95400 95260 95050 95480 WM 95256 AASM upgrade set consisting of S R R WM 95205 AASM master cable R R WM 95207 3 pin ECG master cable R R ECG master cable extension R R WM 95252 master cable bracket g R R 2 WM 95233 set of electrodes for SOMNOlab 2 R R polysomnography device WM 95097 removable card for Application 5 R amp K R R WM 95237 upgrade symbol for polys
29. SOMNOlab 2 may be used on patients with cardiac pacemakers The device may only be operated and stored under the ambient conditions stated in the technical data Please comply with section 7 Hygiene treatment on page 68 to prevent infection or bacterial contamination Plug all sensor connectors into the specified connection points Ensure that sensors and sensor cables are applied in accordance with specification Incorrectly attached sensor cables may lead to injuries If you are using an electrical isolation module route the connecting lead in such a way as to avoid injury to the patient The device may deliver incorrect measuring results if drugs which change blood color or measured physiological parameters are taken 36 Safety instructions If you are using multiple sockets only connect the SOMNOlab 2 polygraphy system to them If you are using SOMNO ab 2 as part of a mobile sleep diagnosis SOMNOmobil system do not use any additional multiple sockets Please note the instructions for use of the mobile sleep diagnosis SOMNOmobil system Multiple sockets which are used in a variety of locations may not be placed on the floor Do not use an extension cable to connect SOMNOlab 2 The electrodes applied to the patient have electrical contact with other conductive parts of the application part The electrodes may not have contact with any other conductive parts which do not belong to SOMNO ab 2 Do n
30. Start and end of measurement for outpatient measurement Switch on SOMNOlab 2 for configuration using the 6 key The device automatically switches off again after 15 minutes if you do not perform any further actions e g sensor test You can also switch the device off manually after configuration using key 6 SOMNOlab 2 switches on at the time set for measuring to start and starts recording SOMNOlab 2 switches off automatically at the programmed time After the measurement your patient takes off the sensors and the SOMNOlab 2 basic device and stows all the parts in the carrying bag Start and end of measurement for inpatient measurement Switch on SOMNOlab 2 SOMNO ab 2 starts as soon as recording has been started in the SOMNOlab PC software Start recording manually It is possible to start recording manually This function needs to be activated in the software under Extras Options If the function has been activated the device needs to be configured once Only from this point can you start a recording manually independently of a configuration by keeping key 6 depressed for three seconds The configuration of the previous measurement is always used in this case Further 60 Operation operation e g setting the duration of measurement can be found in the software 5 4 Important notes for your patient Observe the following points so that you and your patient are not irritated by faulty measurements
31. adapter and the pressure measurement tubes must be clean and free of fluid The pressure measurement tube may not be kinked 30 Description e The Pneumo T adapter should be attached securely and tightly to the mask e The internal measurement tube of the therapy device should not pass through the Pneumo T adapter otherwise measurement will be inaccurate Position sensor in SOMNOlab 2 The position sensor integrated in the device only works properly if SOMNOlab 2 is attached with the aid of the belts in accordance with these instructions for use otherwise faulty measurements may occur Thorax sensor Two thorax sensors are integrated in the device with protection These sensors detect respiratory movements of the thorax They are made of a skin friendly synthetic material The T belt is for attaching the thorax sensors and the device to the patient s body e The T belt marked yellow is manufactured to a normal size that marked green to an extra large size Select the belt suitable for your patient e Ensure that the belt is adequately tight when the sensors are put on Inadequate tension may lead to loss of signal amplitude or complete signal failure The belt may not cause chafing however Your patient must still be able to breathe freely The belt is made of a skin friendly elastic fluffy tape Description 31 Abdomen sensor Use the abdomen sensor in combination with the abdominal belts The abdomen
32. ann 38 Safety instructions 3 Combination with therapy systems 3 1 Devices Note 3 2 Masks Important You should also follow the instructions for use for the mask You can combine SOMNO ab 2 with common CPAP BiLevel and APAP therapy systems to form a control system The two systems are quick and easy to couple up via the Pneumo T adapter which is plugged between the tube and the mask The Pneumo T adapter of SOMNO ab 2 has been tested with all Weinmann therapy devices If third party devices are used the increased flow resistance may lead to restricted trigger function You can combine SOMNO ab 2 with the masks commonly used in sleep apnea applications These must have a EN ISO 5356 1 connection Combination with therapy systems 39 4 Installation 4 1 Install the driver for data transfer via the network USB server Follow the instructions for use for the USB server Our hotline is available for installing the USB server 4 2 Install driver for the card reader unit for CompactFlash cards Follow the instructions for use for the card reader unit for CompactFlash cards Our hotline is available for installing the card reader unit for CompactFlash cards 4 3 Prepare connection of SOMNOlab 2 Connect USB PC electrical isolation module 40 to PC for cable communication The electrical isolation is to protect the user the patient The USB PC electrical isolation module must always be used
33. ate the device in the SOMNOlab PC software under Extras Options General by putting a tick in the item Supported devices to activate this option The SOMNOlab PC soft ware crashes Power failure of the electricity supply or interruption to the LAN connection during a mea surement Restart the PC and the SOMNO ab PC software Resume the measurement Troubleshooting 77 10 Maintenance servicing SOMNOlab 2 must be serviced by the manufacturer or by a qualified specialist dealer every two years to guarantee its functional capability The following tasks must be performed e A function test takes place in SOMNO ab 2 e The pressure sensor for xPAP pressure and flow measurement is tested and recalibrated if necessary As soon as a pressure calibration becomes necessary this automatically appears in the SOMNOlab PC software under Events and remarks e The electrophysiological amplifiers are checked for accuracy and may be recalibrated e The function and accuracy of all sensors and connectors are checked e Defective parts and contaminated tubes are replaced If SOMNOJab 2 is used daily replace theCompactFlash card every 2 years See also the section entitled 6 Handling the battery on Page 64 If you have any questions or problems contact our hotline on telephone no 49 40 54702 101 e mail somnocheck hotline weinmann de 78 Maintenance servicing 11 Disposal
34. ax sensor Sensor integrated in device Max charge current 1 A ethod Piezoelectric measurement ae discharge lt 1A Saona Charge cycles 500 Respiratory flow Charging time with device switched off Approx 3 hours at 25 C with battery discharged snore sensor ntegrated microphone Position sensor Respiratory flow nasal cannula Pressure sensor Pneumo T adapter Pressure sensor Position sensor Sensor integrated in device Value range Right hand side left hand side front back standing ethod Log mean value of sound pressure signal micro phone or of pressure fluc uations pressure sensor Accuracy of position Approx 45 15 86 Technical data Electrodes Contact proof con nectors to 1 5 mm DIN 42802 CE 0197 The right to make design modifications is reserved Pulsoximetry sensor Parameter Value range g Unit Precision comment Min Max Sensor wavelengths 660 905 nm Sensor heat output Maximum rise in temperature by 2 C at 0 20 mW eer application location Signal quality A signal quality gt 90 is good below that 0 100 SpO values and pulse frequency may be unreliable SpO2 measurement SpO measuring range 70 lt SpO lt 100 better than 2 45 100 precision SpO lt 70 not validated Measuring dynamics First r
35. battery before using the device for the first time e Your patient should put the sensors on him or herself under your instruction Application instructions When you program SOMNDOlab 2 it is possible to print out the programmed configuration under Extras Application Diagram The printout contains a diagram of the configuration Instructions for use for the patient You can print out the instructions for use for the patient in the corresponding language in the SOMNOlab PC software under SOMNOcheck 2 SOMNOlab 2 Patient Guide SOMNOlab 2 and its associated parts may not be brought into contact with injured or infected skin Dress any wounds with a stable dressing beforehand Instruct your patient to wear pajamas under the system The scope of supply includes different belts 45 and 46 The belts marked yellow are manufactured to a normal size those marked green to an extra large size Select the belt suitable for your patient Ensure that the colored ends of the belt are on the right hand 50 Operation Note On the rear of the SOMNOlab 2 are applica tion instructions which will help you connect sensors and or electrodes correct ly Once the device has been attached to the body however this application instruction is no longer vis ible so always attach the adhesive electrodes and the electrode cables to the body before you put on the device side of the body Use the attachment be
36. between the skin and the elec trodes are too high Clean the skin and use new electrodes SOMNOlab 2 displaying no signals Plug connections are not properly connected Ensure the connections are firm Channels not configured in display Configure the channels Channels not configured in measuring mode Repeat the measurement with the cor rect configuration Fault in the USB PC electrical isolation module Disconnect all cables from the USB PC electrical isolation module then recon nect Tip If access to the USB PC elec rical isolation module is poor disconnect the USB cable from the Transferbox 2 then restore the connec ion after a minimum of 3 s The electrophysiological sig nals are noisy The cables are receiving interfer ence from the environment or are interfering with one another Put the electrode cables in different positions No connection can be made between the PC and SOMNOlab 2 Interference in radio section not on the SOMNO ab 2 effort All data are also stored internally in the device You can read the data out the next day Cable connection between device and PC is interrupted Check all cable connections LED for power supply not on Power supply unit not con nected to the electricity supply Connect the device to the electricity supply The battery is not supplying any current Contact springs have no contact Put th
37. c being measured Maximum of one of the elec Coesoutatterimoed trodes on the R amp K or AASM P master cable has 5 10 kQ not ance measurement f ideal but acceptable signal Only with PSG R amp K quality or PSG AASM During impedance measurement all three LEDs of the respiratory inputs flashing simultane ously Note Impedance values of the electrodes can be called up in the SOMNOlab software Flashing slowly 1x in 2 sec Several electrodes on R amp K or AASM master cable have 5 10 kQ no electrode gt 10 kQ not ideal but acceptable qual ity Flashing 1x per sec At least one electrode on the R amp K or AASM master cable has over 10 kQ check electrode unacceptable signal quality The LED of the corre sponding signal stops flashing once the impedance test is com plete Impedance of the electrode in question lt 5 kQ OK or sensor signal present Only with PSG R amp K or PSG AASM During the imped ance measurement the LED on the ECG master cable connec tion flashes Note Impedance values of the electrodes can be called up in the SOMNDOlab software Flashing rapidly 4x per sec Impedance of electrodes on ECG master cable being mea sured Goes out after imped ance measurement Maximum of one of the elec trodes on the ECG master cable has 5 10 kQ not ideal but acceptable signal quality Flashing slowly 1x
38. connection Hl B with stopper 4 Connection for abdomen sensor 33 9 j A 5 LEDs 6 Button 7 Ba 9 Battery Right hand side 10 Pressure connection A with stopper t 11 Thorax sensor 12 Connection for pulsoximetry sensor 5 LEDs 8 Connection for charging data transfer cable tery catch 10 see above together with 1 connection for 31 16 Connection for 17 or 28 1 See above connection for 23 4 Overview SOMNOlab 2 polygraphy device and SOMNOlab 2 R amp K AASM polysomnography devices Left hand side 1 Pressure connection B with stopper 2 Electrode connections 4 3 Connection for 3 pin ECG master cable were 4 Connection for ae abdomen sensor 33 Front Right hand side 10 Pressure connection A with stopper _ 2 Electrode connections ___44 Thorax sensor 9 Battery 7 Battery catch Rear electrode connections 2 Electrode connections 14 Removable card with application __ locations I 2 Electrode connections 15 Z electrode 5 LEDs 12 Connection for pulsoximetry sensor 8 Connection for charging data transfer cable Top 13 Connection for master cable 31 16 Connection for 17 or 28 1 See above connection for 23
39. d nasal cannulas The tube may not be pinched during the measurement Description 29 Note Snore detection generally only works correctly if it is correctly configured in the SOMNOlab PC software If necessary check the set tings in the PC software be fore performing snore detection See also online Help relating to the SOMNOlab PC software The respiratory flow nasal cannula is a disposable item To obtain correct measuring results also open the second pressure connection during the measurement Snore detection This is effected primarily from the respiratory flow nasal cannula If snoring is to be detected from the respiratory flow snore sensor the respiratory flow nasal cannula must be deactivated If a Pneumo T adapter is connected snore detection is automatically performed from the Pneumo T adapter Pneumo T adapter The Pneumo T adapter is used when making therapy settings and checking therapy in combination with xPAP devices The Pneumo T adapter can be used in combination with the respiratory flow oral sensor to enable oral respiration to be detected Large quantities of secretion colds or blood nosebleeds may impair the measurement of respiratory flow and snoring Ensure that the pressure measurement tubes are correctly connected on the Pneumo T adapter and the device If the tubes are confused inspiration and exhalation will be shown the wrong way round in the recording The Pneumo T
40. d storage ANA 60 C 10 C Transport and storage temperatures Protect from wet od Fragile CE 0197 CE symbol confirms that the product conforms to the applicable European directives 10 Overview 1 Description 1 1 Intended use Note These instructions for use describe the devices of the SOMNOlab 2 PG platform Sections which are not relevant to the SOMNO ab 2 effort or which are relevant only for the delivery options PSG R amp K and PSG AASM are marked accordingly The item numbers listed in the text which follows are identical to the item numbers in the overview on pages 4 5 and 6 SOMNOlab 2 SOMNOlab 2 effort is a data recording system for registering recording and storing biosignals It is used to identify sleep related respiratory disorders and associated risk factors as well as other sleep disorders e g PLM to support diagnosis and for making therapy settings and checks Fields of use are inpatient and outpatient examinations in sleep laboratories and outpatient examinations in the medical field based outside hospitals The signals recorded are transferred to the PC software wirelessly does not apply to SOMNOlab 2 effort by cable or by memory card The SOMNOlab PC software is for recording saving processing visualizing evaluating documenting and archiving patient related biosignals and for configuring the device The device is operated by the
41. e battery in again Battery has been charged more than 500 times no longer reach ing maximum capacity Message in the software Replace the battery Battery defective e g as a result of a short circuit or defective charging electronics Replace the battery Yellow LED on battery flashing Ambient temperature too high during charging e g device lying on a windowsill in the sun shine Charge the battery at a lower ambient temperature Poor noisy signals transmitted for ExG Filter configuration of the visual ization filter not set to suit signal Adapt the low pass and high pass fil ters in the filter configuration see online Help 76 _ Troubleshooting 9 2 SOMNO ab software Fault Cause of fault Remedy Program cannot make a connection between the PC and SOMNO ab 2 The radio link has been broken All data are also stored internally in the device You can read the data out the next day The charging data transfer cable is not connected to the PC Connect the cable Fault in the USB PC electrical isolation module Disconnect all cables from the USB PC electrical isolation module then recon nect Tip If access to the USB PC elec rical isolation module is poor disconnect the USB cable from the Transferbox 2 then restore the connec ion after a minimum of 3 s The corresponding diagnosis device is not activated Activ
42. e to prevent it becoming kinked and wind the cable around the sensor and the carrier plate The carrier plate can be cleaned and disinfected like the sensor Attach respiratory flow nasal cannula The respiratory flow nasal cannula is used for diagnosis You can use respiratory flow nasal cannula 23 simultaneously with respiratory flow oral sensor 28 1 Remove the two protective stoppers if present from pressure connections 1 and 10 on SOMNOlab 2 and screw the tube of the nasal cannula onto connection B marked with the nasal cannula 54 Operation 2 Grasp the double tube to the left and right so that the cannulas point upwards 3 Now position the cannulas in the nostrils and guide the tubes along behind the ears and under the chin Align the sleeve at the fork so that the tube is loose but does not slip out of position Tip Greasing the nostrils slightly with Vaseline for example can increase wearing comfort and pre vent drying out Attach Pneumo T adapter Pneumo T adapter 31 is used when making therapy settings and checking therapy in combination with xPAP devices Note The Pneumo T adapter can be used in combination with respiratory flow oral sensor 28 to enable oral respiration and oral leakages to be detected A 1 Ensure that the mask has an integrated exhalation system If a mask without an H S integrated exhalation system is used a separate exhalation system must be used
43. eGts alien Aare 71 7 4 Disposable items 71 7 5 Accessories 71 7 6 Non medical devices 72 8 Function check 73 9 Troubleshooting 75 9 1 SOMNOlab 2 SOMNDOlab 2 effort basic devices en se 75 9 2 SOMNDOlab software 77 10 Maintenance servicing 78 11 Disposal 2200e scene 79 12 Scope of supply replacement partslaccessories 80 12 1 Basic devices 81 12 2 Pulsoximetry sensors 82 12 3 Flow snore measurement therapy check 83 12 4 Data transfer 83 12 5 Power supply options 84 12 6 Accessories 84 13 Technical data 85 13 1 Safety distances 90 13 2 Technical data for non medical components 90 14 Warranty cc cece eee 91 15 Declaration of conformity 92 2 Contents Overview Platform SOMNOIab 2 SOMNOlab 2 effort effort Polygraphy system SOMNOlab 2 SOMNOlab 2 PG Sleep diagnosis system Polygraphy system expanded SOMNOlab 2 PSG R amp K SOMNOlab 2 Polysomnography system SOMNOlab 2 PSG AASM Polysomnography system Overview 3 Rear electrode connections 14 Removable card 2Ha with application locations I SOMNOlab 2 effort polygraphy device Left hand side Front 1 Pressure
44. eaction after Final value reached after Measured at desaturation resaturation between 96 and 84 SpO under favor 8 s fable measuring conditions The values may be extended in the event of poor pulse strength or movement artifacts N a First display after application Measured at default setting The poorer the 3 6 s measuring conditions the more unreliable the first value displayed Pulse frequency measuremen Pulse frequency measuring range 30 250 bpm 1 bpm to 2 of displayed value Measuring dynamics First reaction after Final value after another Maximum values measured in the case of 1 7 s sudden change from 40 to 200 bpm and vice 1 6 s__ versa The times for reaction and final value depend on the difference deviation between beats First display after application Measured at default setting The poorer the 5 8 s measuring conditions the more unreliable the first value displayed Technical data 87 Electrophysiological signals in the basic device not on the SOMNOlab 2 effort EXG channels ECG EEG EMG EOG Dynamic range physical 5 mV 500 pV 250 pV 500 pV value range Resolution 12 bits 12 bits 12 bits 12 bits Amplitude precision 3 3 3 3 Frequency range precision 15 15 15 15 Frequency rangein the 0 05 Hz 0 05 Hz 0 05 Hz 0 05 Hz hardware ap filter in devi e 0 02 Hz 0 5 Hz 2 7 Hz 0 5 Hz
45. ect To do this take a disposable cloth and spray with the spray Then wipe over the correspond ing part e Spray disinfect using MIKROZID LIQUID spray e Disinfect by immersion using gigasept FF new 7 4 Disposable items 7 5 Accessories For hygiene reasons do not use disposable items which have been used instead put the nasal cannula etc in domestic waste The relevant hygiene regulations should be observed in sleep laboratories clinical facilities Follow the instructions enclosed with each accessory Hygiene treatment 71 7 6 Non medical devices Follow the cleaning instructions in the instructions for use for the individual components enclosed with your delivery 72 Hygiene treatment 8 Function check Perform the following measures before each use after any installation note electrodes and wireless data transmission cannot be used on the SOMNOlab 2 effort model Ensure that all devices and sensors used are undamaged and fully functional To this end you can perform an online application check using the PC To do this put on the SOMNOlab 2 polygraphy system with all its sensors and electrodes and perform a measurement on yourself You can as sess the plausibility of the data on the PC Check the function of the electrode cables in particular Replace these after no more than 50 uses Connect SOMNO ab 2 to the PC using the charging data transfer cable or wirelessly Ensure that
46. edical devices The complete text of the declaration of conformity can be found at www weinmann de 92 Declaration of conformity Weinmann Ger te f r Medizin GmbH Co KG P O Box 540268 D 22502 Hamburg Kronsaalsweg 40 D 22525 Hamburg T 49 0 40 5 47 02 0 F 49 0 40 5 47 02 461 E info weinmann de www weinmann de Center for Production Logistics Service Weinmann Ger te f r Medizin GmbH Co KG Siebenstiicken 14 D 24558 Henstedt Ulzburg WM 9667 1c 05 2014 EN partner for life WEINM NN medical Mtechnology
47. finger Check the position of sensors and electrodes before the measurement note electrodes cannot be used with the SOMNO ab 2 effort Too high a transitional resistance between the electrodes and the skin due to poorly affixed electrodes for example delivers unsatisfactory recordings Check the electrodes are secure and check their electrical properties You can check the quality of electrode application by means of an impedance test see Perform a sensor test not on the SOMNOlab 2 effort on Page 58 Replacing the battery does not cause the loss of any saved data as these are archived on the memory card Once 30 minutes have passed without a battery or a power supply however the device will have to be reconfigured Let your patient know that he or she needs to be able to see microphone 20 on respiratory flow snore sensor 17 in the mirror after it has been put on Tell your patient to check again that the belts are secure once he or she lies down 62 Operation 5 5 RemoveCompactFlash card Proceed as follows to read out or change the CompactFlash card RemoveCompactFlash card 1 Remove the battery by pressing battery latch 7 and taking the battery out of the bracket Press the button on the left of the inserted CompactFlash card once briefly The button now protrudes slightly Press the button again this time until it engages again with a click and is flush with the housin
48. flow and snoring noises e The sensor beads consist of thermistors They detect respiratory flow by means of the temperature difference between exhaled and inhaled air e The microphone registers the patient s snoring noises Respiratory flow oral sensor 28 The respiratory flow oral sensor enables you to record your patient s oral respiratory flow for diagnosis with the respiratory flow nasal cannula and to set or check therapy e The sensor beads consist of thermistors They detect respiratory flow by means of the temperature difference between exhaled and inhaled air Pneumo T adapter 31 The Pneumo T adapter is used to check therapy in combination with a nasal cannula It registers the respiratory flow and the snoring of your patient Description 21 during therapy and measures the therapy pressure prevailing in the mask e Pressure fluctuations on inspiration and exhalation are passed from the mask to the device through the pressure measurement tubes Exhaling air generates a slight overpressure whilst inhaling it accordingly produces a vacuum Respiratory breaths can be deduced from the differences in pressure e Snoring noises are measured via rapid changes in pressure e Therapy pressure is deduced from the static component of the pressure signal The function of non medical devices Note that all non medical devices must be installed outside the patient environment i e ata distance of at least 1 5 m
49. formation about the software Among other topics the online Help and user s manual describe the following e how to prepare and configure the device for outpatient and inpatient measurement e how to configure and set the display e the course of the measurement e evaluation of the measurement Before you give your patient the SOMNO ab 2 you can double check by querying status whether all settings and the current time of the SOMNO ab 2 are correct Check all settings If you discover incorrect settings program SOMNOlab 2 again Operation 43 Notes Each time SOMNO ab 2 is reprogrammed the clock time in the basic device is compared to the system clock time of your PC It is therefore important that the time is set correctly on your PC otherwise the recording will start at the wrong time If data transfer to the PC is interrupted the measured data are still stored in the device The signals are shown as a zero line in the software You can read out all the data the next day Note that an incorrectly set display configuration may lead to misinterpretations Note that channels deactivated in the device configuration are not transmitted The configuration of visualization does not affect archiving If you are operating several devices check that the basic device is correctly assigned to the PC 5 1 Attach and position electrodes not on the SOMNOlab 2 effort Note The battery must be charged before you use SOMNO
50. g This pushes theCompactFlash card out of the device slightly and you can now remove it InsertCompactFlash card 1 Push in theCompactFlash card with the contact holes facing the device and the labeling facing upwards until it engages with a click and is flush with the housing Push the battery into SOMNO ab 2 until it engages with an audible click Operation 63 6 Handling the battery SOMNOlab 2 has a high capacity lithium ion battery The charging electronics are in the power pack These allow continuous capacity monitoring If a defect is detected in the battery e g capacity is too low there is a visual warning from the LEDs on the device Caution If you remove the battery you must insert a new or recharged battery within 30 minutes otherwise SOMNOlab 2 will have to be reconfigured for any offline measurement which may be planned You can also remove the power pack from the SOMNO ab 2 and charge it using the charging data transfer cable in combination with the USB PC electrical isolation module as well as the power supply unit If you have a second battery you can return the device to your patient without delay and charge the empty battery later For how to remove change the battery see the section entitled 6 2 Service life on Page 66 Battery capacity is checked every time the device is configured and the PC software firmware generates an information signal 6 1 Charge battery
51. g the examination room you can supplement these data with those stored on the CompactFlash card SOMNO ab 2 is supplied with power by a replaceable battery making it independent of the electricity supply Replacing the battery does not cause the loss of any saved data as these are archived on the memory card Once 30 minutes have passed without a battery or a power supply however the device will have to be reconfigured You can also leave the device permanently connected to the electricity supply and operate it using the charging data transfer cable SOMNOlab 2 has a built in position sensor The sensor registers if and when the patient is lying on his her front back or side or whether s he is upright The device likewise has an effort sensor integrated in the housing Integration reduces the amount of cleaning required and increases the service life of the sensor Use key 6 to start a sensor test impedance check with a double click nicht bei SOMNO ab 2 effort LEDs allow you to determine during a sensor test impedance check whether an electrode is well 16 Description attached and if not which one it is the attachment of the sensors can also be checked In addition SOMNOlab 2 shows by means of a yellow LED next to the battery symbol on the battery whether the battery is currently being charged Charging status can also be interrogated by the SOMNOlab PC software as a capacity monitoring function is integrated in
52. hment belts The measuring sensors convert the movements into electrical signals as a consequence of the piezoelectric effect Electrophysiological signals Electrophysiological signals are measured by electrodes Gold cup or adhesive electrodes can be used for this e Electroencephalogram EEG The EEG records electrical activity in the brain so called brain currents by using electrodes to measure and record fluctuating voltages In polysomnography the EEG allows information about sleep stages to be deduced for example e Electrooculogram EOG The EOG registers eye movements Voltages generated by the movements of the eye are reg istered as an electric dipole in adjacent elec trodes e Electromyogram EMG The EMG registers muscle activity at the chin legs 20 Description The EMG on the chin is required to distinguish the different stages of sleep The EMG on the legs is specifically for diagnosing restless legs syndrome RLS and periodic leg movement in sleep syndrome PLMS e Electrocardiogram ECG In the ECG the electrical voltages which occur between certain points of the skin as a conse quence of cardiac excitation are registered SOMNOlab 2 enables changes to or disorders of cardiac rhythm to be detected Respiratory flow snore sensor 17 The respiratory flow snore sensor allows you to record your patient s nasal and oral respiratory
53. homecare SOMNOlab 2 SOMNOlab 2 effort polygraphy system SOMNOlab 2 PG expanded polygraphy system SOMNOlab 2 PSG R amp K polysomnography system SOMNOlab 2 PSG AASM polysomnography system Description of device and instructions for use WEINM ANN medical Mtechnology Contents 1 Description 2 005 11 1 1 Intended use 11 1 2 Description of function 12 1 3 Signals and messages 23 1 4 Measuring conditions 26 Safety instructions 33 3 Combination with therapy Systems cece eee eee 39 3 1 DEVICES tree dale 39 3 2 MASKS 4 202 sage Mads 39 Installation 0202000 40 4 1 Install the driver for data transfer via the network USB SOIVEN boost kan 40 4 2 Install driver for the card reader unit for CompactFlash cards 40 4 3 Prepare connection of SOMNOlab2 40 Operation 002ee eee 43 5 1 Attach and position electrodes not on the SOMNOlab 2 effort 44 5 2 Put on SOMNOlab 2 device and sensors 50 5 3 Start and end of measurement 60 5 4 Important notes for your patient 61 5 5 RemoveCompactFlash card 63 Handling the battery 64 6 1 Charge battery 64 6 2 Service life oa lee es 66 63 Storage fakin ee 67 6 4 Battery disposal 7 Hygiene treatment 68 7 1 Intervals n n ee ea 69 7 2 Elea a aa an 70 7 3 Disint
54. ication via network Connect the USB server to the network as described in its instructions for use Now plug the USB connector of the converter cable into the USB port of the USB server Commissioning should be performed by a Weinmann product specialist for SOMNOlab Contact our hotline for this see Page 78 Installation 41 Connect card reader unit for CompactFlash cards Connect the card reader unit for CompactFlash card to the PC as described in the instructions for use for the card reader unit 42 Installation 5 Operation Note This section includes all the information you need to make it easy to operate the SOMNOlab 2 polygraphy system Any applications and explanations within the SOMNOlab PC software and the higher level SOMNOmanager administrative program can be obtained from online Help which contains a user manual you can print out This can be accessed via the menu item Manual The user s manual of the SOMNOlab PC software can be found on the CD Application of the sensors handling of the device and handling of the battery of SOMNO ab 2 are described in this and the next section Read these sections through carefully The short form instructions for use SOMNO ab 2 in 7 steps and all the other instructions for use for SOMNOlab 2 can be printed out using the SOMNOlab PC software Using the SOMNO ab PC software Please refer to the online Help or user s manual for operation and in
55. ient the SOMNOlab 2 polygraphy system to take in the carrying bag This protects the device and the sensors Ensure that the battery is charged before you put the SOMNO ab 2 polygraphy system on your patient and give it him her for measurement The belt is made of a skin friendly elastic fluffy tape Put on abdomen sensor Abdominal belt 46 is for attaching abdomen sensor 33 to your patient s body The abdominal belt marked yellow is manufactured to a normal size that marked green to an extra large size Select the belt suitable for your patient The belt may not cause chafing Your patient must still be able to breathe freely The belt is made of a skin friendly elastic fluffy tape Use abdomen sensor 33 in combination with the abdominal belts The abdomen sensor detects abdominal movements of respiration 52 Operation 1 Draw the short connecting piece with the snap fit buckle through the eye of the sensor 2 Place the abdominal belt round the patient s abdomen and pass the abdominal belt through the other eye of the sensor The sensor must be on the center of the abdomen 3 Close the belt using the buckle 4 Ensure that the belt is always taut on the body otherwise the respiratory movements may not be detected 5 Connect the sensor to connection 4 on the device Attach respiratory flow snore sensor The respiratory flow snore sensor is used for diagnosis 1 Unwi
56. in 2 sec Several electrodes on ECG mas ter cable have 5 10 kQ no electrode gt 10 kQ not ideal but acceptable qual ity Flashing 1x per sec At least one electrode on the ECG master cable has over 10 kQ check electrode unac ceptable signal quality Description 25 Note If poor impedance is measured for the R amp K or AASM master cable and the ECG master cable gt 10 k9 the LEDs on the device do not indicate which of the individual electrodes has poor impedance In this case call up the values for the individual electrodes via the SOMNO ab PC software in order to establish the faulty electrode 1 4 Measuring conditions Follow the instructions for use on attaching the sensors the accessories Contamination of the sensors by secretions electrode paste residues or moisture for example can lead to faulty measurements If the instructions for use are observed the product is not sensitive to environmental effects Pulsoximetry sensor Ensure that the LEDs and the receiver in the sensor are not dirty or moist The pulsoximetry sensor is calibrated to pulsoximetric hemoglobin oxygen saturation assuming blood is free of dysfunctional hemoglobin by means of referenced measurements obtained from fractional saturation measurement Functional oxygen saturation of arterial blood is determined with the aid of the pulsoximetry sensor on the patient s finger in other words non invas
57. ing intended use record the following sleep related parameters e electrodes for the electrophysiological channels e effort sensors thorax and abdomen movements e pulsoximetry sensor for detecting oxygen saturation pulse frequency and pulse wave e respiratory flow snore sensor thermistors and microphone e respiratory flow nasal cannula pressure sensor e oral thermistor for recording oral respiration for therapy check thermistors e Pneumo T adapter for detecting respiratory flow snoring and xPAP pressure pressure sensor Respiratory flow nasal cannula 23 The respiratory flow nasal cannula detects respiratory flow and snoring in combination with the pressure sensor integrated in SOMNO ab 2 Inspiration is registered by the vacuum generated exhalation via the overpressure generated Snoring generates pressure fluctuations in the nostrils which are likewise registered Pressure measurement reacts more sensitively to slight flow limitations than thermal measurement when the mouth is closed It is independent of ambient temperature and also allows a visual assessment of Note The changes in pulse fre quency measured corre spond sufficiently accurately to the changes in heart frequency triggered by a sleep relat ed apnea syndrome Note See also the instructions for use enclosed with the pulsoximetry sensor the temporal flow contour The signals may be attenuated in oral respira
58. item Tubes for the Pneumo T adapter Disposable item Hygiene treatment 69 7 2 Clean Caution Caution Use mild detergent or a damp cloth You can wipe down all the components of SOMNOlab 2 using a slightly damp cloth and a mild detergent If the Pneumo T adapter is very dirty you can also immerse it in a mild soap solution Leave all the components to dry fully in air before using them again No liquid may get into SOMNOlab 2 or into the plug connections or sockets The sensors may not be immersed in liquid Before cleaning it is essential to seal the pressure connections of the device using the stoppers Remove the power pack Disconnect the charging data transfer cable from the battery before each cleaning operation and disconnect the power supply unit from the power supply socket In a washing machine The carrying bag and the belts can be washed in a washing machine at 40 C Leave the bags and belts to dry in air e Do not use a tumble dryer e Remove the abdomen sensor beforehand 70 Hygiene treatment 7 3 Disinfect You may disinfect some parts by wiping or immersion when required e g in the event of infectious diseases or unusual contamination see 7 1 Intervals on Page 69 Follow the instructions for use for the disinfectant used We recommend using suitable gloves e g household or disposable gloves when disinfecting e Disinfect by wiping with terralin prot
59. ively If the proportion of dysfunctional hemoglobin e g carboxyhemoglobin or methemoglobin is high this will impair measurement accuracy 26 Description Faults in the measurement signal are monitored by the device The device issues error messages when the faults are outside the internally specified limits 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 e g as a result of direct sunlight or operating room lights may falsify measuring results The device then restricts its measuring mode 0 values are displayed There may be a negative impact on pulsation strength This may be the case for example when blood pressure cuffs or arterial catheters are used in the case of arterial occlusion or if the sensor is attached too tightly The device detects movement artifacts suppresses the majority with the aid of various algorithms and issues a message as soon as they become too high It is not possible to rule out false measured values being displayed if movement artifacts persist for a prolonged period With a high proportion of dysfunctional hemoglobins e g carboxyhemoglobin or methemoglobin measurement may deliver a normal result even if the patient is hypoxic Intravascular dyes such as methylene blue indocyanine green or other dyes will significantly falsify the measuring resu
60. lab 2 To do this see the section entitled 6 1 Charge battery on Page 64 The SOMNO ab PC software contains a diagram as an application guide for both master cable options PSG R amp K or PSG AASM to help you position the electrodes Call up the relevant diagram and print it out before continuing if necessary The application instruction for the PSG R amp K option can be found under SOMNOcheck 2 SOMNOlab 2 Electrodes R amp K The application instructions for PSG 44 Operation Notes AASM can be found under SOMNOcheck 2 I SOMNO ab 2 Electrodes AASM Call up the above mentioned diagram in online Help and print it out if necessary First affix all adhesive gold cup electrodes to the right places on your patient s body as described in the following sections Use the press studs to attach the electrode cables to the electrodes Observe the color coding on the application instructions and on the rear of the device Then plug the connectors of the electrode cables into the matching colored sockets of SOMNOlab 2 or of the master cable only with PSG R amp K or PSG AASM Do not affix the electrodes too close together otherwise the cables will short circuit They will then no longer be able to receive a signal Plug the R amp K or AASM master cable into the socket provided only with PSG R amp K or PSG AASM Plug the ECG master cable into the socket provided only with PSG R amp K
61. lt False nails made of acrylic or colored nail varnish may affect measurement accuracy and should be removed before the start of the measurement Description 27 Note Ifthe sensor iscoveredby a blanket ambient tempera ture will rise to body tem perature which may cause faulty measurements Note If the sensor is covered by a blanket ambient tempera ture will rise to body tem perature which may cause faulty measurements Respiratory flow snore sensor Measurement of the respiratory flow curve is based on measurement of the difference in temperature between the flow of inhaled and exhaled air As a result an inadequate signal is detected if ambient temperature is between 33 C and 38 C Sensor beads 18 must be precisely located in the nasal and oral air flow The sensor beads may not be coated with contamination such as secretions otherwise incorrect measurements may result The sensor may only be used again after being dried completely The membrane over microphone 20 may not be damaged In addition to the patient s snoring noises the microphone of the respiratory flow snore sensor also registers ambient noises at typical snore frequencies Ensure that the ambient volume is much lower than the volume caused by snoring noises You can use the respiratory flow snore sensor in combination with the respiratory flow nasal cannula Respiratory flow oral sensor Measurement of the respiratory flo
62. lt to attach the SOMNOlab 2 basic device to your patient s body Attach the device Ts First thread the belt through upper eye a and then through eye b on the side of the device Hang the loop of belt thus formed over your patient s shoulder Now draw the short connecting piece with the snap fit buckle through remaining free eye cand close the belt using the buckle You can adjust the belt to suit the dimensions of your patient s body by adjusting the Velcro tapes It should be firm but comfortable on the body Ensure that the device is secure It should be in the center of the chest sternum Fix the device firmly but comfortably to your patient Only then will the sensors integrated in the device work reliably Otherwise faulty measurements may occur Operation 51 Abdomen sensor Ensure that the belt is always taut on the body and that the sensors and cables are correctly attached but do not cause chafing Your patient must still be able to breathe freely Make it as easy as possible for your patient Put the SOMNO ab 2 system on your patient as a trial Show him her and explain clearly how to put on the sensors in the evening without your help The procedure for putting on the sensors and the device is explained in the instructions for use for the patient Undo just the snap fit buckle on the side of the belt to take the SOMNO ab 2 polygraphy system off your patient again Give your pat
63. lygraphy devices includes either only the SOMNOlab 2 effort components or all the basic components The scope of supply for the polysomnography devices includes all the basic components plus a master cable and the correspondingly adapted firmware PSG R amp K or PSG AASM SOMNOlab 2 effort facilitates fast easy polygraphy SOMNOlab 2 PG facilitates more detailed polygraphy The SOMNOlab 2 PSG R amp K allows polysomnography to be performed using SOMNOlab 2 In the process all the parameters for classifying sleep are recorded and this allows sleep stages to be determined in accordance with the RECHTSCHAFFEN und KALES standard The precise positioning of the electrodes is described in the Manual of standardized terminology techniques and scoring systems for sleep stages of human subjects by RECHTSCHAFFEN and KALES 1968 The SOMNOlab 2 PSG AASM likewise allows polysomnography to be performed with SOMNOlab 2 This option allows sleep stages to be determined in analogy to the AASM standard of 2007 The precise positioning of the electrodes is described in The AASM Manual for the Scoring of Sleep and Associated Events of 2007 14 Description If you wish to acquire one of these options retrospectively send the device straight to Zentrum f r Produktion Logistik Service Weinmann Ger te f r Medizin GmbH Co KG Siebenst cken 14 D 24558 Henstedt Ulzburg Germany Function of SOMNO ab 2 SOMNOlab 2
64. mory card full LEDs on the respira tory inputs Flashing green 1x per sec No sensor signal LEDs on electrodes not on the SOMNOlab 2 effort Flashing rapidly 4x per sec mpedance being measured Goes out after imped ance measurement mpedance of electrode lt 5 kQ OK Flashing slowly 1x in 2 sec mpedance of the electrode lt 10k not ideal but acceptable quality Flashing 1x per sec mpedance of electrode gt 10 kQ check electrode unac ceptable signal quality Description 23 Light emitting diode State Meaning 3 LEDs on left continu ously illuminated Battery life lt 6 h or less than con figured measuring time Battery should be charged All LEDs on device Off Device switched off or record ing in progress LEDs on battery No LED illuminated Bat ery is not connected to the electricity supply Left hand LED illumi nated green Bat trici ery is connected to the elec ty supply Right hand LED illumi nated or flashing yel low Bat ery being charged Left hand LED illumi nated green right LED off Bat ery full 24 Description Light emitting diode State Meaning j Impedance of electrodes on Flashing rapidly 4x per R amp K or AASM master cable se
65. mp or defective Clean the sensors and wipe them dry Replace them if necessary A signal graph has a non physiological curve ug connections are not roperly connected Ensure the connections are firm Per form a sensor test before or during the measurement he electrodes are dirty damp or efective Clean the electrodes and wipe them dry Replace them if necessary ave slipped out of position uring the measurement Repeat the measurement using clean electrodes and check that they are in the correct position P p T d The electrodes have got dirty or h d if he sensor has got dirty or has slipped out of position during the measurement Repeat the measurement using clean sensors and check that they are in the correct position EMC interference in the electrode cables Very rarely certain frequencies of elec tromagnetic radiation from the envi ronment can cause the amplitude of signals to be reduced You can recog nize this interference as fluctuations in amplitude by their non physiological characteristic These amplitude fluctua tions do not influence the frequency or fundamental shape of the basic wave Maintain the stated safety distances from other equipment see 13 1 Safety distances on page 90 Troubleshooting 75 Fault Cause of fault Remedy The ECG other EXG chan nels are displaying a zero line The transitional resistances
66. nd the sensor from carrier plate 21 Place the sensor on your patient s top lip Ensure that the microphone is on the side facing away from the skin remaining visible 2 Pass the cable over the ears and tighten under the chin by pushing up the sleeve 3 Connect the plug of the respiratory flow snore sensor to the round connection 16 on the top of the device 4 Seal off pressure connections 1 and 10 using the enclosed stoppers 5 After the measurement place the sensor back on the carrier plate to prevent it becoming kinked and wind the cable around the sensor and the carrier plate The carrier plate can be cleaned and disinfected like the sensor Operation 53 Note Attach respiratory flow oral sensor Use respiratory flow oral sensor 28 in combination with respiratory flow nasal cannula 23 for diagnosis or in combination with Pneumo T adapter 31 to check therapy set therapy to detect respiration through the mouth 1 Unwind the sensor from the carrier plate Place the sensor on your patient s bottom lip Ensure that the sensor beads are pointing to wards the oral cavity 2 Pass the cable over the ears and tighten under the chin by pushing up the sleeve 3 Connect the plug of the oral thermistor to connection 16 on the top of the device 4 Seal off pressure connections 1 and 10 using the enclosed stoppers 5 After the measurement place the sensor back on the carrier plat
67. omnography R R device WM 95051 Plug of R amp K or AASM master cable R R R S R SIR connection WM 95238 Application sticker S R WM 95239 France Il application sticker S R WM 96551 Set SOMNO ab 2 PSG electrodes single R R R SIR use electrodes Weinmann offers a large range of EXG electrodes which you can purchase individually or in sets as spare parts Contact your Weinmann specialist supplier or take a look at the price list 12 2 Pulsoximetry sensors Order no Article WM Wm wM wM wm 95420 95400 95260 95050 95480 WM 18040 Softtip sensor SpO size S R R R S R R WM 18030 Softtip sensor SpO size M R R R SIR R WM 18035 Softtip sensor SpO size L SIR SIR S R R SIR WM 95105 Pulsoximeter Minimed clip sensor 90 R R R SIR R 140 cm cable 82 Scope of supply replacement parts accessories 12 3 Flow snore measurement therapy check Order no Article m wm oM Wm Wm 95420 95400 95260 95050 95480 WM 94010 Respiratory flow snore sensor for adults R R R SIR R large WM 95082 Respiratory flow oral sensor R R R SIR R WM 94043 Respiratory flow nasal cannula R R R S R R WM 94044 Respiratory flow nasal cannula set SIR S R R R S R WM 94045 Respiratory flow nasal cannula 50 pack R R R S R R Set of 100 diagnostic nasal cannulas ae 330 mm and 1 adap
68. ot connect any third party devices to SOMNOlab 2 e g devices with 1 5 mm plugs Be aware that a safe distance needs to be maintained between SOMNO lab 2 and devices which emit HF radiation e g cellphones otherwise there might be malfunctions see 13 1 Safety distances on page 90 This device requires special precautionary measures as regards electromagnetic compatibility EMC Only install it and put it into operation in accordance with the EMC instructions in the accompanying documentation see 13 1 Safety distances on page 90 Other devices may interfere with SOMNOlab 2 even if these other devices conform to the valid CISPR emissions requirements Do not use SOMNOlab 2 immediately next to other devices and do not stack SOMNO ab 2 with other devices during operation Safety instructions 37 Note Note Use of accessories and cables other than those stated may lead to increased emission or reduced immunity to interference of the device or system SOMNOlab 2 and its associated parts may not come into contact with injured damaged and or infected skin when being attached to the patient Dispose of the accessories in accordance with the regulations applicable in your medical sphere SOMNOlab PC software See the online Help contained in the PC software No software other than the SOMNOlab PC software may be installed or operated on the computer unless it has been approved for this use by Weinm
69. rnal attachment of the 2nd rib on the right and the positive electrode marked yellow or green to the apex of the heart In addition to the recording electrodes a further earth electrode should be attached as an electrical reference The black reference electrode is affixed as shown in the adjacent drawing Operation 47 Tip Use the enclosed disposable adhesive electrodes to affix the ECG The skin is cleaned as for the other electrophysiological signals Fix the electrode cable in position with a plaster This will prevent the cable dropping off as a result of the patient s movements Position EEG electrodes In order to perform a proper sleep recording the EEG electrodes are fixed in accordance with the 10 20 system In addition to the EEG electrodes an additional earth electrode must be affixed to the forehead as an electrical reference Z Use the mastoid electrodes M1 M2 as reference These are easier to affix and are not as susceptible to faults as the ear electrodes A1 A2 RECHTSCHAFFEN and KALES EEG To register the EEG during sleep you need leads C3 and or C4 Use the ear or mastoid electrodes of the opposite side as reference electrodes This gives you leads C3 A2 M2 and or CA A1 M1 AASM 2007 EEG To register the EEG during sleep you need leads O1 C3 and F3 Use the ear or mastoid electrodes of the opposite side as reference electrodes This gives you leads
70. sses and the energy required by the protective circuit is approximately 3 10 a month The battery can be operated and discharged at temperatures between 5 C and 40 C Charging is possible only at battery temperatures between 5 C and 35 C Handling the battery 65 6 2 Service life At temperatures of over 25 C the charging time for the battery increases Charging process You can charge the battery in the device using the power supply unit 35 supplied or if you have two batteries charge them externally In the latter case you can give the device to a new patient on a change of patients without wasting any time 1 Plug connector 37 of power supply unit 35 into connection 43 on the USB PC electrical isolation module 40 Plug one connector of charging data transfer cable 38 into the corresponding connection 8 on the battery the other connector into the corresponding connection 41 on the USB PC electrical isolation module 40 Plug connector 37 of power supply unit 35 into a power supply socket Yellow LED 5 next to the battery symbol on the battery comes on Charge the battery until the yellow LED on the battery goes out Save yourself work Leave the power supply unit permanently plugged into a power supply socket and the USB cable connector plugged into your PC This means the connector for SOMNOlab 2 is always handy on your desk Li ion batteries have a service life of about 500 charging
71. ter R R R SIR R WM 96503 Set of 20 tubes for Pneumo T adapter R R R SIR R WM 95263 Flexible tube adapter R R R S R R WM 94042 Stopper for pressure measurement R R R R R connection 12 4 Data transfer Order no Article m WM vn wm wm g 95420 95400 95260 95050 95480 WM 95085 TCP IP network USB server R R R S R R WM 95076 USB cable 2 m SIR SIR SIR R SIR WM 95087 Card reader unit for CompactFlash cards R R R SIR R WM 95202 CompactFlash card SIR S R S R R S R Scope of supply replacement parts accessories 83 12 5 Power supply options Order no Article m en en En WM 95420 95400 95260 95050 95480 WM 95089 Primary adapter GB R R R S R R WM 95092 Primary adapter USA Japan R R R SIR R WM 95098 Primary adapter AU NZ R R R S R R 12 6 Accessories Order no Article wm ae Wo _ m 95420 95400 95260 95050 95480 WM 95300 Transferbox 2 R R R R WM 95358 SOMNObutler 2 stationary R R R R WM 95359 SOMNObutler 2 mobile R R R R 84 Scope of supply replacement parts accessories 13 Technical data SOMNOlab 2 SOMNOlab 2 effort basic devices Product class to 93 42 EEC la Dimensions WxHxD 80 x 150 x 34 mm Weight device excl sensors SOMNOlab 2 approx 300 g SOMNOlab 2 approx 220 g effort Electromagnetic compatibility EMC to EN 60601 1 2 Radio in
72. terference suppression Radio interference immunity Test parameters and limit values can be obtained from the manufacturer on request EN 55011 EN 61000 4 Parts 2 to 6 Part 11 Temperature range Type of protection against ingress of water IPXO operation 5 C to 40 C storage 10 C to 60 C 5 ower supply basic 37VDC device Power supply battery 7 5 V DC Relative humidity for operation and stor age 25 to 95 no condensation ean power con sumption approx 340 mW Air pressure for oper ation and storage 700 to 1060 hPa Battery operating ime wireless online mobile approx 10 hours approx 20 hours Storage medium CompactFlash card max 2 GB Max recording period for one measurement 12 hours Data transfer online Wireless via radio signals at 2 4 GHz not on the SOMNOlab 2 effort USB 1 1 or higher electrically isolated Electrical rating power supply unit Input 100 240 V 50 60 Hz 400 mA Output 7 5 V DC Classification to EN 60601 1 Type of protection against electric shock Degree of protection against Protection class Il Type BF electric shock Readout of saved data USB 1 1 or higher Remove CompactFlash card read in via CompactFlash card card reader unit Observe the temperature range of the respiratory flow snore sensor
73. the battery You can transfer the saved data to the PC via the USB PC electrical isolation module It can likewise be used to charge the battery using the power supply unit supplied A battery can also be charged if it is not inserted in the device The SOMNOlab PC software is for recording saving processing and evaluating biosignals This is to support the diagnosis process and set and check the therapy of sleep disorders The firmware for the SOMNOlab 2 SOMNOlab 2 effort basic devices communicate with the SOMNOlab PC software via a secured data transmission protocol Function of the SOMNO ab PC software The data transferred during the measurement are saved and visualized The data read in after the measurement are automatically analyzed in accordance with time and value criteria and the occurrence of respiratory problems is registered The SOMNO lab PC software can perform the following automatic analyses as a function of the data recorded e PLM analysis not on the SOMNO ab 2 effort e snore analysis e cardiorespiratory analysis e arousal analysis not on the SOMNO ab 2 effort Description 17 See also the instructions for use enclosed with the nasal cannula e sleep stage analysis not on the SOMNO ab 2 effort You can assess the results in accordance with your own criteria on the basis of the analysis results and the signals displayed Function of the sensors The sensors have the follow
74. tion so we recommend simultaneous use of the respiratory flow oral sensor Signal display and automatic analysis are adapted to suit the original Weinmann nasal cannula Pulsoximetry sensor 32 The pulsoximetry sensor is used to measure pulsoximetry signals oxygen saturation of the blood and the patient s pulse frequency The primary components of the sensor are two LEDs and a receiver diode Several SpO gt values are determined for each pulse wave split pulse wave algorithm For each oxygen saturation value recorded SOMNOlab 2 calculates a quality index which in dicates the quality accuracy of the SpO value measured If the signal is disrupted by movements the number of useable measured values is reduced Where signals are not disrupted there is a high number of signals available A disrupted mea sured signal accordingly generates a low quality value whilst an undisrupted measured signal re sults in a high quality value The quality signal adopts values of between O and 100 The quality signal can be helpful when assessing long term SpO measurements as it suggests that artifacts occurred during the measurement Description 19 Thorax sensor 11 and abdomen sensor 33 The thorax and the abdomen sensor are for recording movements of the thorax and abdomen In this process respiratory movements cause changing tensions on the measuring sensors in the attac
75. w curve is based on measurement of the difference in temperature between the flow of inhaled and exhaled air As a result an inadequate signal is detected if ambient temperature is between 33 C and 38 C The sensor bead must be precisely located in the oral air flow 28 Description The sensor bead may not be coated with contamination such as secretions otherwise incorrect measurements may result The sensor may only be used again after being dried completely You can use the respiratory flow oral sensor in combination with the respiratory flow nasal cannula 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 sensor is for diagnosis measurement it cannot be used simultaneously with the Pneumo T adapter for xPAP measurements The difference between nasal pressure and ambient pressure is detected Large quantities of secretion colds or blood nosebleeds may impair the measurement of respiratory flow and snoring External noises e g traffic may impair snore measurement The respiratory flow nasal cannula must be connected directly to pressure measurement connection B If you select the wrong connection you will obtain incorrect measuring results in the respiratory flow and for snore detection Cardiorespiratory analysis will no longer work properly Do not use damage
76. you are simultaneously monitoring your patient s blood pressure with a cuff do not attach the pulsoximetry sensor to the arm to which the cuff is attached 56 Operation Note No adhesive tape may be attached to the sensor housing Tip Attach the pulsoximetry sensor to one of your patient s index fingers Ensure that the finger marking on the sensor is pointing upwards The sensor should be com fortably and securely positioned It should not squeeze the finger If required fix the sensor in position by attaching the sensor cable firmly to the finger with adhesive tape for example Plug the sensor connector into socket 12 on SOMNOlab 2 Ensure that the connector is firmly located Attach R amp K or AASM master cable only with PSG R amp K or PSG AASM ile Affix the electrodes for the EEGs and EOGs as described from Page 48 Plug the connector for the R amp K or AASM master cable into connection 13 Attach ECG master cable only with PSG R amp K or PSG AASM 1 Affix the electrodes for the ECG as described from Page 47 onwards Plug the connector for the ECG master cable into connection 3 Use the ECG master cable extension contained in the set as the connection between the ECG master cable Operation 57 Note and the device Leave the extension plugged into the

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