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SOMNOmedics SOMNO HD NGD050, Instruction Manual, Page: 2 / 52

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SOMNOmedics GmbH 

– Am Sonnenstuhl 63 – D-97236 Randersacker 

Tel.: (+49) 931 / 35 90 94 - 0 

– Fax: (+49) 931 / 35 90 94 - 49 

E-Mail: [email protected] - Internet: www.somnomedics.eu 

 

Rev. 10 

14.11.2019 

SOMNO  HD  is  a  trade  mark  of  the 
SOMNOmedics company. 

 

Summary of Contents for SOMNO HD NGD050

Page 1: ...1 Instruction Manual SOMNO HDTM SOMNOmedics GmbH Am Sonnenstuhl 63 D 97236 Randersacker Tel 49 931 35 90 94 0 Fax 49 931 35 90 94 49 ha E Mail info somnomedics de Internet www somnomedics eu...

Page 2: ...GmbH Am Sonnenstuhl 63 D 97236 Randersacker Tel 49 931 35 90 94 0 Fax 49 931 35 90 94 49 E Mail info somnomedics de Internet www somnomedics eu Rev 10 14 11 2019 SOMNO HD is a trade mark of the SOMNOm...

Page 3: ...ECG 18 EEG EOG 20 Attaching the PSG headbox according to AASM Guidelines 20 Application for 32 channel headbox according to 10 20 System 20 EOG EEG combi electrode 21 CPAP sensor and CPAP device 22 M...

Page 4: ...e display 36 Blood pressure calibration on the display 36 Warnings on the display 37 The docking station 38 Data transfer via docking station 38 Recharging the battery 38 Firmware Update 39 Troublesho...

Page 5: ...when the device is in waiting mode 2 Return button by pressing the return button the previous display in the menu is shown 3 Confirm to confirm and to move forwards in the menu 4 Light sensor detects...

Page 6: ...6 2 Wait for the unlock screen to appear then move the slider form left to right 1...

Page 7: ...gnosis The software is supposed to be used by trained medical experts DOMINO generates reports of the recorded and manually scored data number index average values maximum and minimum ranges This devi...

Page 8: ...protected against temperatures below 0 C and above 50 C Ingression of dust dirt and water may damage the device Regarding ingression of humidity and water the main device complies with protection cla...

Page 9: ...ics cannot guarantee error free operation if third party memory cards are used The memory card must not be removed during recording as this may lead to data loss Since 1st October 1998 batteries may n...

Page 10: ...3 channel ECG RIP effort sensor thorax Multiplex RIP effort sensor for paediatric use 1 Channel ECG with body position for paediatric applications SpO2 sensor SpO2 pulse pleth paediatric or adult Lim...

Page 11: ...The CE icon shows that the SOMNO HD complies with the applicable regulations of the EU and that the conformity was declared by the manufacturer IP22 This device complies with the IP Protection Class 2...

Page 12: ...of the patient Alternatively you can place the device in the thoracic region Please take note of the following images in order to place the main device and the sensors correctly on the patient s body...

Page 13: ...in sensors signals are shown on the display The luer lock plug of the nasal cannula is screwed directly into the sensor port Connecting the luer lock plug to the main device Insert the headbox plug in...

Page 14: ...main device Insert the SpO2 plug into the bottom as shown in the image Connecting the SpO2 plug to the main device Note In order to prevent damage of the sensor patient should take off SpO2 sensor wh...

Page 15: ...om the front Follow the steps shown in the following image Connecting the effort belt to the main device using the thin end Wrap the belt around the patient Insert the wider side of the effort belt to...

Page 16: ...ollowing image You can use adhesive tape to secure the cable Attaching the finger sensor Leg EMG sensor The active electrodes EMG should be attached to the skin in the area of the anterior tibialis mu...

Page 17: ...hat the cable does not restrict the patient s breathing or endanger the patient in any way Attach the sensor with the flat side of the microphone towards the skin The patient s head should be as strai...

Page 18: ...and that the lower element is located directly in front of the mouth Adjust fixing sleeve small rubber sleeve along the tube in order to ensure the sensor s position during the whole measurement The s...

Page 19: ...electrodes should run under the pyjamas nightshirt The connecting cable of the corresponding ECG sensor should run on top of the pyjamas nightshirt to the main device ECG via Headbox Insert the two E...

Page 20: ...er canthus of left eye EOG r 1cm below outer canthus of right eye F3 4 See 10 20 System C3 4 See 10 20 System O1 2 See 10 20 System M1 2 Behind left right ear mastoid select boniest area EMGref centre...

Page 21: ...mbi electrode The EOG EEG combi electrode is sticked to the forehead in the middle using a disposable electrode The blue electrode is placed behind the right ear the yellow one next to the right eye a...

Page 22: ...the angled piece of the mask and the oxygen hose Connect the supplied thin silicone pressure tube to the port of the oxygen adapter Connect the other end of the pressure tube to the port of the press...

Page 23: ...o electrodes is proportional to the skin resistance The sensor can be plugged into any of the plugs of the main device Connecting the EDA sensors In preparation for the recording the patients need to...

Page 24: ...ode of the ECG or headbox can be used For additional information regarding the integration of the sensor into a montage or the analysis please read the DOMINO software manual Oesophageal pressure Sens...

Page 25: ...ld be fixated with tape for strain relief on the back of the patient s hand and the patient s arm as well External Battery for extended recording time The external battery is extending the usual recor...

Page 26: ...status The external battery is charged if the orange LED is on For fully charged external batteries the green LED is on The charging time for a completely empty external battery is approximately 6 hou...

Page 27: ...election and to move forwards in the menu 4 Light sensor detects ambient light Display functions 5 Battery status yellow battery is being charged green battery is fully charged docking station is conn...

Page 28: ...it button turns blue and confirm by touching the confirm button 3 Display stop recording If you wish to cancel the shut down process tap on the return button 2 Navigation in the menu Tap on the return...

Page 29: ...ls are displayed during the measurement Use this function if you do not want the patients to see their pulse rate blood pressure etc during the measurement During the first 5 minutes of a measurement...

Page 30: ...f all wireless sensor assigned to this device All signals of the wireless sensors are grouped on one scree Tap on this symbol to view all wireless signals During wait mode Abort wait mode You can abor...

Page 31: ...on the power 1 button and unlock the screen Tap on the patient marker icon and select a marker from the displayed list to assign an event If a specific marker is not selected only a patient marker wil...

Page 32: ...ialization dialogue will re open Please see further information about the initialization process in the DOMINO software instruction manual 4 3 1 2 Online recording An online recording can be started v...

Page 33: ...e above you can start a measurement directly on the device When Bluetooth is active the data can be displayed in an online recording or with the SOMNOmedics app on a tablet 4 3 2 1 Input via display S...

Page 34: ...responding raw data In the signal view before a measurement the message Not recording is displayed in the background Numerical display of parameters The following parameters are shown as numerical val...

Page 35: ...tionally the battery capacity is visualised with a battery symbol next to the sensor icon Scrolling channels Swipe vertically on the display to see further channels of the same signature group See ind...

Page 36: ...mogram from the SpO2 finger sensor Start the BP calibration by tapping on the corresponding symbol In wait mode programmed start the blood pressure calibration can be performed until 10 minutes before...

Page 37: ...ing and make sure that the patient is sitting still so that no artefacts appear Hold to turn off Keep the finger on the button until the circle is completed Press confirm to shutdown Accept the reques...

Page 38: ...tation is connected to the power The lower LED displays yellow if the inserted battery is charging and green if it is fully charged Data transfer via docking station When the main device is plugged in...

Page 39: ...orrectly 4 Performance Problem Performance Problem Restart of the device necessary 5 Measurement was stopped due to low battery voltage Stopped low batt 6 Device cannot access the memory card Recordin...

Page 40: ...sor is connected twice Duplicate sensor Sensor must be removed to continue 24 Blood pressure calibration was performed by user BP calibrated by user 25 Wrong headbox type is connected to the SOMNO HDT...

Page 41: ...aged Note The device and the sensors cannot be sterilized or autoclaved Disinfection of the sensors electrodes effort belts Item Disinfectant Trade name Concentration Duration Frequency Other Headbox...

Page 42: ...Mikrozid AF cloths Ready to use Ready to use 5 min 5 min After use Remove adhesive residues if necessary Follow manufacturer s instructions Laryngeal microphone Wipe disinfection e g Terralin Liquid M...

Page 43: ...sage and maintenance of the rechargeable battery An accumulator is a rechargeable battery The storage of electrical energy is carried out by an electrochemical process The supplied battery is a lithiu...

Page 44: ...s and weight Headbox PSG 10 x EEG EOG 24 Bit 1465 V HP 0 3 Hz LP 35 Hz 3 66 x 60 x 12 mm 80 g 2 x EMG 24 Bit 1465 V HP 0 3 Hz LP 110 Hz 3 1 x ECG 24 Bit 5860 V HP 0 3 Hz LP 110 Hz 3 Headbox EEG32 25 x...

Page 45: ...ed after 3 years at the latest Docking station Connect to PC via USB connection Status and charging LED Touch Display 480 x 320 Pixel Signal control on the display Programmed starting and ending time...

Page 46: ...e circuit for overcharging and deep discharging For protection of the battery cells a protective circuit is integrated with an overcharging protection of 4 3 V and a deep discharging protection of 2 4...

Page 47: ...ervals of 3 years Otherwise we cannot guarantee the expected product life cycle Storage and transport Store the device and its sensors in the supplied transportation bag Pack the products in antistati...

Page 48: ...Patient data saved on the memory card of the main device must be deleted for data protection reasons Note Since 1st October 1998 portable batteries must no longer be disposed of in household waste af...

Page 49: ...n accordance with IEC 60601 1 2 close to SOMNO HD Refer to the tables below in this section for specific information regarding the compliance to the standard IEC60601 1 2 In accordance with the EMC re...

Page 50: ...r quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 U for cycle 95 dip 40 U fo...

Page 51: ...for 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters m Interfe...

Page 52: ...in urgent cases including severe technical problems 06 00 a m 12 00 p m 49 0 1 72 6 75 69 90 Send us a message by fax at any time 49 0 9 31 35 90 94 49 Send us your query by email any time service som...

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