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Related Manuals for SOMNOmedics SOMNO HD NGD050
Summary of Contents for SOMNOmedics SOMNO HD NGD050
- Page 1 Manual SOMNO HD SOMNOmedics 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...
- Page 2 SOMNOmedics 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...
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Page 3: Table Of Contents
Content Getting started – Quick Guide ..................5 Introduction ........................7 Intended use ......................7 Patients ........................7 Safety instructions ....................7 System components & accessories ............... 10 Labels/symbols ...................... 11 Preparing the patient: applying main device, sensors and electrodes ......11 Connecting the sensor plug to the main device ............ - Page 4 Using the touch display: Interactive buttons and their meaning ......28 Bluetooth on/off....................31 Sound on / off ....................31 Patient markers/event markers ............... 31 Initialization of a measurement ................31 Initialization via DOMINO software..............31 Initialization via the device ................33 Signal view on the display ..................
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Page 5: Getting Started - Quick Guide
Getting started – Quick Guide Control and display elements of the main device Control functions Control functions which are active and selectable are backlit. Power button: when touching the power button (1) the device can be switched on and off respectively, or, during the measurement, the display can be switched on. The button flashes red when recording or green when the device is in waiting mode. - Page 6 2 Wait for the unlock screen to appear then move the slider form left to right...
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Page 7: Introduction
Introduction Thank you for purchasing the SOMNO HD from SOMNOmedics. Please read the following instruction manual carefully before installing and using the device. We gratefully accept any feedback and helpful suggestions in order to improve our product or our instruction manual. - Page 8 (mobile) phones, CB radio devices, microwave ovens etc. where the electrical field may exceed 10 V/m (according to norm IEC 60601-1-2). If a battery change is required, only batteries specified by SOMNOmedics may be used. SOMNOmedics cannot guarantee error-free operation if different batteries are used.
- Page 9 Any damage of the warranty seal “Warranty void, if seal is broken”, located on the back of the device case, will lead to immediate loss of warranty. The main device should only be used with micro SD cards specified by SOMNOmedics. SOMNOmedics cannot guarantee error-free operation if third-party memory cards are used.
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Page 10: System Components & Accessories
Connect the power supply to a freely accessible socket. In case of a defect it should be possible to unplug it easily. Make sure the power supply is not used in close proximity to the patient. System components & accessories Main device Internal channels: body position, movement, flow/snore, CPAP-pressure, RIP effort abdomen, ambient light, patient marker, battery status... -
Page 11: Labels/Symbols
RIP effort belt abdomen RIP effort belt thorax --- Check the current price list for all available options --- The label shown is an example. Individual icons on the label may differ from country to country. Labels/symbols Information, Symbols, Icons and Classifications on the Type Label of SOMNO HDTM and its accessories HF-Transmitter with integrated Bluetooth Protocol. -
Page 12: Connecting The Sensor Plug To The Main Device
Note: Attach the belts and sensor/electrode wires securely to the patient to avoid strangulation. Fix the sensor cable with adhesive tape if needed. Recordings with children may only be performed while under continuous observation. We recommend placing the main device in the abdominal region of the patient. Alternatively, you can place the device in the thoracic region. - Page 13 Inserting a sensor plug into the main device The device automatically recognises the connected sensors. Main device with plugged-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 into the designated port and position.
- Page 14 Connecting the headbox plug to the 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 while washing hands or splashing water.
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Page 15: Sensors For Polysomnography
Sensors for Polysomnography Attaching the effort belts Insert the thin end of the effort belt into the slot on the left side of the main device (seen from the front). Follow the steps shown in the following image: >>Click<< Connecting the effort belt to the main device using the thin end Wrap the belt around the patient. -
Page 16: Nasal Cannula
Attaching the effort belts to the patient Nasal cannula Attach the nasal cannula to the patient’s nose. Make sure that the holes of the sensor elements (highlighted red in the following image) are placed directly below the nostrils. Note: Nasal cannulas are single-use items. Adjust fixing sleeve in order to secure the sensor’s position. -
Page 17: Microphone
Attaching the PLM electrodes to the legs Note: Do not use dried-out adhesive snap electrodes. Only use electrodes provided by SOMNOmedics to ensure the best signal quality. Note: When using the leg EMG sensors, always use a ground lead electrode to ensure optimal signal quality. -
Page 18: Flow Sensor (Thermistor)
microphone is placed approximately 1 cm apart from the nasal tip and towards the nose. Then, . For the patient’s comfort the the cable is plug into the adapter and into the SOMNO HD cable is routed over the head and down towards the device along the throat (compare the following figure). - Page 19 Note: Use disposable snap electrodes only. Clean the skin before attaching the ECG electrodes. Note: The main device must not be placed directly on the skin. The cables of the ECG 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.
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Page 20: Eeg/Eog
Attaching the 3-channel ECG sensor EEG/EOG Attaching the PSG headbox according to AASM Guidelines Positions of the electrodes (PSG according to AASM) GND: Centre of forehead REF: Applied to Cz, see 10/20 system EOG l: 1cm above outer 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... -
Page 21: Eog/Eeg Combi Electrode
Electrode positions (10-20) Plug the EEG electrodes in according to the labelling and colour coding of the headbox. Use the same kind of electrodes everywhere (e.g. only Ag/AgCl or only gold cup). Make sure the bridging cable is connected for EEG32 channel headbox. Briding cable EOG/EEG combi electrode green... -
Page 22: Cpap Sensor And Cpap Device
Further information for integrating the sensor in a montage/recording and the analysis please read the DOMINO software manual. CPAP sensor and CPAP device Measurements with the Differential Pressure Sensor There are two ways to connect the CPAP sensor to the CPAP device: A) If the CPAP mask does not have a port for a pressure tube: Place an oxygen adapter (sold separately) between the angled piece of the mask and the oxygen hose. -
Page 23: Measurements With The Dual Pressure Sensor
Measurements with the Dual Pressure Sensor If using the dual pressure sensor no additional connection between SOMNO HD and the mask is necessary. The dual pressure sensor is connected directly to the pneumotachograph and the cable is connected to the main device. Additional Sensors Sensor for recording the electrodermal activity (EDA Sensor) The electrodermal activity is used to describe electrical phenomena of the skin because the... -
Page 24: Oesophageal Pressure Sensor
The electrodes for recording the intercostal activity are placed directly on the patient’s skin. Beforehand the skin needs to be cleaned with Nuprep abrasive gel. Afterwards the second and third intercostal space (counting from the lowest rip) can be determined by palpating. Then, place one electrode in each intercostal space along the frontal axillary line. -
Page 25: External Activity Sensor
Nasal application of oesophageal Balloon catheter For further information regarding the initialisation of a recording or the analysis of recorded data please read the DOMINO software manual. External Activity Sensor The external activity sensor is supposed to record the movement of the extremities and should be applied to the patient’s non-dominant wrist. -
Page 26: Operating The Main Device
External battery with power supply Before using the external battery, please make sure the SOMNO HD and the external battery are fully charged. Otherwise the specified recording time cannot be reached. For charging connect the external battery to the connection piece of the provided power supply. Two LEDs on the power supply are indicating the charging status. -
Page 27: Switch-On /-Off Of The Device
Control functions which are active and selectable are backlit. Power button: when touching the power button (1) the device can be switched on and off respectively, also, the display can be turned on during the measurement. The button flashes red when the device is in measuring mode or green when the device is in standby mode. -
Page 28: Navigation In The Menu
Display turning off When the device is ready to be switched off you see the following screen: Display confirm shutdown Confirm the notification by touching the confirm button (3) or the check mark on the screen. If you wish to switch off the device during a measurement (i.e. abort the recording), you can either use the power button or the red Tap on “Stop”... - Page 29 Domino. Press “Start” to begin a measurement directly on the device. You will then be guided through the menu. SOMNOmedics Tapping on the SOMNOmedics logo will display the Logo device name (serial number), the installed firmware version and SOMNOmedics contact details.
- Page 30 A menu opens where you can enter the patient’s height. Body height This information will be added to the patient’s data and is necessary for the blood pressure calculation (if activated). Bluetooth on/off Activate or deactivate the Bluetooth function by tapping on this button.
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Page 31: Bluetooth On/Off
Stop recording Tap to stop the recording Bluetooth on/off This setting only applies during the measurement mode. Bluetooth is always active before the measurement. If Bluetooth is active, you can connect to a PC or tablet to review the recording data in real-time. - Page 32 Main device in docking station Virtual docking station, no main device connected If the docking station is connected to the PC, a connection between the device and the PC is initiated automatically. A virtual docking station is displayed on the PC monitor. It shows relevant information on the device status.
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Page 33: Initialization Via The Device
Initialization via the device As an alternative to the 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. -
Page 34: Signal View On The Display
If you select a “new” montage, a new montage will be generated based on what sensors are connected during the signal check. 4.3.2.3 Intelligent connect function of the headboxes For both, manual recording start on the SOMNO HD display or initialisations at the PC but without headbox, only connected headbox channels are recorded. -
Page 35: Scrolling Channels
Respiratory Thorax effort Flow (nasal cannula) Flow (thermistor) Leg EMG sensors (PLM) l/r Microphone Cardio 1 channel ECG → if the ECG is recorded on the headbox, the ECG signal can be accessed via “HR” in the EEG display SpO2 sensor (saturation, pulse, pleth) PSG headbox (EOGs, EEGs, EMGs) First the impedance head appears and thereafter the signals are displayed... -
Page 36: Zoom
Zoom In the single-channel review mode, it is possible to zoom the signal. A vertical ↕ zoom movement (stretching and pinching two fingers on the display) changes the signal amplitude; a horizontal ↔ zoom movement changes the temporal resolution of the signal. The time scale is shown on the bottom right on the display. -
Page 37: Warnings On The Display
Warnings on the display Message Meaning Untransferred recording. Overwrite? This message appears when a performed measurement has not been transferred yet. Connect the device with the docking station to transfer the measurement. If you wish to delete the measurement, confirm with “yes”. Missing Sensors. -
Page 38: The Docking Station
and reference electrode. Those must be connected to achieve impedances < 50 kΩ. Duplicate Sensor. Please remove A sensor is used twice or a sensor of the same duplicate! group (e.g. 1-channel ECG and 3-channel ECG) is connected. The user must remove the duplicate sensor before continuing. -
Page 39: Firmware Update
2. Remove the battery from the device, pull the clip in the middle of the docking station upwards and insert the battery under the clip. The LED on the docking station shines orange during charging and green as soon as the battery is fully charged. Insert the charged battery to the device with the arrow pointing up and front. -
Page 40: Cleaning And Maintenance
Waiting mode was stopped User aborted Wait Only possible with manually on the device. mode several manual confirmations on display Montage deleted User deleted Entry is set if user chooses “new” montage manually on the device. Montage in the menu Battery was removed during Stopped, batt. - Page 41 Note: This SOMNOmedics device complies with protection class IP 22 regarding ingression of humidity and water. Cleaning should be performed with a lint-free and damp cloth. Note: Ensure that no liquids seep into the device during cleaning! Note: Other surface disinfectants listed by the DGHM are permitted as long as the surface of the device or sensor will not be damaged.
- Page 42 Effort sensor Wipe disinfection: After use Remove adhesive e. g. residues if necessary. Follow manufacturer’s Terralin Liquid Ready to use 5 min Mikrozid AF cloths Ready to use 5 min instructions! ECG (active Wipe disinfection: After use Remove adhesive electrode) e.
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Page 43: Maintenance Interval
Note: disinfection solutions must be prepared with cold water. Maintenance interval After 3 years of use, send the main device to SOMNOmedics for validation and inspection. The inspection includes an examination for damage, a function test and a firmware update. -
Page 44: Technical Data
Technical data Component Sensor Resolution Measurement range Frequency range Accuracy Measurements and weight 0.07 – 15 Hz Thermistor 16 Bit 115 x 78 x 25 mm 190 g incl. battery 0.5 – 10 Hz Activity external 16 Bit ± 1 g ±... - Page 45 Storage medium Industrial Grade µSD card, 1 GB in standard version Temperature range in use 0 – 50 °C, Storage: -20 – 70 °C Only use memory cards authorised by SOMNOmedics While in use: 10 – 90 %, non-condensing Humidity When stored/transported: 10 –...
- Page 46 Rated output voltage of rechargeable 4.65 V battery pack Maximum discharge current 1.5 A Nominal capacity 4.7 Ah Protective circuit for overcharging and deep For protection of the battery cells a protective circuit is integrated with an overcharging protection of 4.3 V and a deep discharging discharging protection of 2.4V.
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Page 47: Service
Warranty of security, reliability and functionality of the device is only provided by SOMNOmedics if: • add-ons, modifications and repairs are carried out exclusively by persons authorised by SOMNOmedics or made by SOMNOmedics personnel. • the device is only handled by instructed persons and skilled workers. -
Page 48: Accessories And Replacement Parts
The warranty only refers to the main device SOMNO HD and includes a period of 24 months. Note: If you use accessories which are not authorised by SOMNOmedics and it comes to service provision, this will be invoiced. Note: It is not permitted to open the device. Repairs, opening the device and modifications are carried out exclusively in the factory. - Page 49 The use of accessories, sensors, and cables other than those provided by SOMNOmedics GmbH may result in increased emission and/or decrease immunity of this device.
- Page 50 Immunity test IEC 60601- test level Compliance level Electromagnetic environment – guidance 2,4,6 kV contact 2,4,6 kV contact Electrostatic discharge Floors should be wood, (ESD), IEC61000-4-2 concrete or ceramic tile. If floors 2,4,8 kV air 2,4,8 kV air are covered with synthetic material, the relative humidity should be at least 30 %.
- Page 51 Guidance and manufacturer’s declaration — electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Electromagnetic environment – Immunity test IEC 60601- test level Compliance level...
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Page 52: Service Hotline Und Contact
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@somnomedics.de Get free access to current software updates via service login on our website www.somnomedics.eu * Saturday and Sunday from 07:00 a.
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