Compumedics Somfit User Manual
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Compumedics Somfit User Manual

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Somfit
USER GUIDE

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Summary of Contents for Compumedics Somfit

  • Page 1 Somfit USER GUIDE...
  • Page 2 AH808 Issue 0 19 August 2019 English For other languages, please contact Compumedics. This work is copyright. Apart from any use as permitted under the Copyright Act 1968 no part may be reproduced by any process without written permission from Compumedics Limited.

  • Page 3: Table Of Contents

    2. Product Overview ..........13 Somfit device .............. 13 Somfit charger ............14 Somfit electrode ............15 Somfit application ............15 3. Using the Somfit ............ 17 Before use ..............18 Prep Forehead ............19 Prep Somfit ..............20 Apply Somfit ............... 21 Open App ..............
  • Page 4 Functional Oxygen Saturation ........34 Heart Rate ..............34 Sleeping position ............34 Sound ................. 34 Light ................35 EEG ................35 6.11 Environmental Protection ........... 36 6.12 Electromagnetic Emissions Statement ....... 37 Page ii Somfit Installation and User Guide © Compumedics Ltd 2019...

  • Page 5: Before You Begin

    1 . B e f o r e Yo u B e g i n The Somfit User Guide contains the necessary information for the proper use of the Somfit device and its application. WARNING Read this manual. Please familiarise yourself with the contents of the manual before using the device.

  • Page 6: Limited Warranty

    B e f o r e Y o u B e g i n Limited Warranty Compumedics Limited warrants each new device to be free from defects in workmanship and materials under normal use and service for a period of twelve (12) months from the date of shipment.

  • Page 7: Intended Use

    Contraindications Discontinue use if the patient displays distress, discomfort, or adverse reaction. The Somfit is not intended for use as part of life support equipment such as vital signs monitoring in intensive care units. Somfit Installation and User Guide Page 3...

  • Page 8: Labelling Definitions

    Where you see this symbol, it means that the indicated action is mandatory Separate collection of waste electrical and electronics equipment (WEEE) necessary (European Union directive 2002/96/EC on WEEE) Page 4 Somfit Installation and User Guide © Compumedics Ltd 2019...
  • Page 9 This symbol indicates the serial number of the unit This symbol indicates the reference or part/assembly number of the unit This symbol indicates the authorize representative in the European Community. Somfit Installation and User Guide Page 5 © Compumedics Ltd 2019...
  • Page 10 1 means the enclosure protects against vertically falling water drops. This symbol indicates that the product has “European Conformity” and meets the required regulations Page 6 Somfit Installation and User Guide © Compumedics Ltd 2019...

  • Page 11: Warnings And Cautions

    Use only the Power Adapter and Charging Cable provided with the Somfit to recharge the battery. Use of the Somfit adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the Somfit and the other equipment should be observed to verify that they are operating normally.
  • Page 12 WARNING Do not immerse in fluid or run fluid over the Somfit. CAUTION Do not use the Somfit if it appears or is suspected to be damaged. Do not repair, open or modify the Somfit. Do not use the Somfit if the internal parts have been exposed to liquids.

  • Page 13: Tips

    The Power Adapter is double insulated and does not require a grounded outlet. The Somfit has a Lithium-ion battery which may be restricted for certain types of travel. The Somfit is not provided sterile. Somfit performance may be affected if used outside the operating ranges specified.

  • Page 14: Product Support

    B e f o r e Y o u B e g i n 1.10 Product Support If you have a question regarding the correct use of the Somfit and/or any of its components first refer to the relevant sections in this User Guide for the solution.
  • Page 15 B e f o r e Y o u B e g i n C h a p t e r 1 Repairs of Compumedics Limited equipment under warranty or service contracts must be made at authorised repair centres. If...
  • Page 16 01069 Dresden, Fax: Germany +49 7731 79 769 99 Compumedics E-Mail Address Compumedics can also be contacted by sending e mail via the Internet. This will be most beneficial to international users. The Compumedics e-mail address is: support@compumedics.com Compumedics Home page Visit Compumedics home page on the World Wide Web at: http://www.compumedics.com...

  • Page 17: Product Overview

    The Somfit system consists of four components that the user can interact with. Somfit device This is the actual Somfit device that does the recording and transmission of the data which represents your sleep signals. Somfit Installation and User Guide Page 13 ©...

  • Page 18: Somfit Charger

    P r o d u c t O v e r v i e w Somfit charger The Somfit charger. The Somfit charger is used to charge the Somfit device. The charger has a standard USB-C connector and can be charged with any USB compliant charger.

  • Page 19: Somfit Electrode

    C h a p t e r 2 Somfit electrode This is a single use medical grade electrode for measuring your brain waves and also holding the Somfit in place. Somfit application This is loaded onto an android or iPhone and provides the user interface to start and manage the recording.
  • Page 20 C h a p t e r 2 P r o d u c t O v e r v i e w This page is intentionally blank Page 16 Somfit Installation and User Guide © Compumedics Ltd 2019...

  • Page 21: Using The Somfit

    3 . U s i n g t h e S o m f i t The Somfit is designed to be used every night of the week. You can also use it less often but it’s a good idea to use it often enough to build up some history of your sleeping patterns as this will help in determining the best course of action.

  • Page 22: Before Use

    U s i n g t h e S o m f i t Before use Before using the Somfit you need to make sure the device is charged. Once you have confirmed the device is charged you are ready to apply the device using the electrode.

  • Page 23: Prep Forehead

    U s i n g t h e S o m f i t C h a p t e r 3 Prep Forehead First you need to prepare the forehead. Somfit Installation and User Guide Page 19 © Compumedics Ltd 2019...

  • Page 24: Prep Somfit

    C h a p t e r 3 U s i n g t h e S o m f i t Prep Somfit Take the Somfit off the charger and attach it to the electrode that you have for the nights study. Page 20 Somfit Installation and User Guide ©...

  • Page 25: Apply Somfit

    U s i n g t h e S o m f i t C h a p t e r 3 Apply Somfit Now apply the Somfit to your forehead. Open App Open the application on the phone. Make sure you are signed into your account and then you can start recording.
  • Page 26 C h a p t e r 3 U s i n g t h e S o m f i t Page 22 Somfit Installation and User Guide © Compumedics Ltd 2019...

  • Page 27: Go To Sleep

    C h a p t e r 3 Go to sleep Now you can just go to sleep as normal. Note that even if you are aware of the Somfit you will soon forget and sleep normally. Somfit Installation and User Guide Page 23 ©...

  • Page 28: Wake

    C h a p t e r 3 U s i n g t h e S o m f i t Wake When you want up you just use the phone and press end study. Page 24 Somfit Installation and User Guide © Compumedics Ltd 2019...
  • Page 29 U s i n g t h e S o m f i t C h a p t e r 3 Once the study is stopped you can carefully remove the electrode and Somfit from the electrode then return it to the cradle. Somfit Installation and User Guide Page 25 ©...

  • Page 30: Review

    U s i n g t h e S o m f i t Review Once the study is stopped the data will automatically be sent to the Somfit server for analysis. Once analysis is complete you can review the results of your sleep. Page 26 Somfit Installation and User Guide ©...

  • Page 31: Service And Maintenance

    4 . S e r v i c e a n d M a i n t e n a n c e Cleaning instruction WARNING This is an electrical device. Confirm that the Somfit is not charging. Symbols or specific instruction etched on the instruments should be strictly followed.
  • Page 32 Packaging: The device does not require packaging. Storage: There is no specific storage requirement for this device. Compumedics recommend to store the device in area that provides protection from dust and extreme temperature/humidity. Page 28 Somfit Installation and User Guide...

  • Page 33: Periodic Maintenance And Inspection

    Inspect the device at a minimum of once per year. Technical information such as diagrams and parts list are available on request from service@compumedics.com Somfit Installation and User Guide Page 29 © Compumedics Ltd 2019...
  • Page 34 C h a p t e r 4 S e r v i c e a n d M a i n t e n a n c e This page is intentionally blank Page 30 Somfit Installation and User Guide © Compumedics Ltd 2019...

  • Page 35: Associated Equipment

    Associated Device and Consumeables Somfit main unit P/N: 8040-0001-00 Somfit Charger P/N: 8040-0101-00 USB-C Cable P/N: 3140-0001-00 Somfit Carry Bag P/N: 4640-0001-00 Somfit Sensor pad P/N: 7040-0001-00 Preppad P/N: 95000016 Somfit Installation and User Guide Page 31 © Compumedics Ltd 2019...

  • Page 36: Related Equipment

    If you need additional equipment of this type, that was not purchased as part of your Grael system, then please contact your Compumedics representative for advice on compatible devices. Page 32 Somfit Installation and User Guide ©...

  • Page 37: Specifications

    Transport and Storage conditions Temperature range: -10°C (+14°F) to 50°C (+122°F) Humidity: 20 to 90% RH (non-condensing) Atmospheric 70 kPa to 106 kPa pressure: Altitude: Less than 3,000 m (9,843 ft) Somfit Installation and User Guide Page 33 © Compumedics Ltd 2019...

  • Page 38: Operating Conditions

    Range: 25 bpm to 250 bpm Accuracy: 3 bpm or 3%, whichever is greater Sleeping position Range Front, back, left, right, upright Sound Range Envelope detected sound non calibrated Page 34 Somfit Installation and User Guide © Compumedics Ltd 2019...

  • Page 39: Light

    Number: 2 differentials Type: 2 Channels with three electrodes. Shared middle electrodes Connection: Press stud to custom Somfit electrode Sample rate: 159 sample per second Input Impedance: > 24 MΩ at DC, > 18 MΩ at 10Hz Input bias current: <...

  • Page 40: Environmental Protection

    The crossed-bin symbol invites you to use these disposal systems. If you require information on collection and disposal of your Compumedics device please contact your Compumedics office or local distributor. Page 36 Somfit Installation and User Guide...

  • Page 41: Electromagnetic Emissions Statement

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Somfit, including cables specified by manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 42 This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Page 38 Somfit Installation and User Guide © Compumedics Ltd 2019...
  • Page 43 IEC 61000-3-2 communication services. The user might need Voltage fluctuations/ to take mitigation measures, such as flicker emissions relocating or re-orienting the equipment. Complies IEC 61000-3-3 Somfit Installation and User Guide Page 39 © Compumedics Ltd 2019...
  • Page 44 S p e c i f i c a t i o n s Guidance and manufacture’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of COMPUMEDICS should assure that it is used in such an environment. IEC 60601 test...
  • Page 45 IEC characteristic of a typical 61000-4-8 location in a typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to application of the test level. Somfit Installation and User Guide Page 41 © Compumedics Ltd 2019...
  • Page 46 Interference may occur in the vicinity of equipment marked with the following symbol: Page 42 Somfit Installation and User Guide © Compumedics Ltd 2019...
  • Page 47 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Somfit Installation and User Guide Page 43 © Compumedics Ltd 2019...
  • Page 48 S p e c i f i c a t i o n s Recommended separation distances between portable and mobile RF communications equipment and the Somfit. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 49 C h a p t e r 6 S p e c i f i c a t i o n s This page is intentionally blank Somfit Installation and User Guide Page 45 © Compumedics Ltd 2019...
  • Page 50 For more information please contact: Compumedics Limited, Compumedics USA, Inc.: Compumedics Europe Australia: GmbH: Headquarters 5015 West WT Harris Blvd, Werdauer Strasse 1-3, 30-40 Flockhart Street Suite E 01069 Dresden Abbotsford VIC 3067, Charlotte, NC 28269 Australia Ph: +61 3 8420 7300...

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