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Compumedics Somfit AH808 User Manual

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Document Title: Somfit User Guide
Document Number: AH808
Somfit
USER GUIDE
AH808 Somfit User Guide - Version 0
Page 1 of 54

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Summary of Contents for Compumedics Somfit AH808

  • Page 1 Document Title: Somfit User Guide Document Number: AH808 Somfit USER GUIDE AH808 Somfit User Guide - Version 0 Page 1 of 54...
  • Page 2 Release date Language AH808 Version 0 04 November 2020 English AH808 Issue 1 Draft English AH808 Issue 0 Draft English For other languages, please contact the manufacturer Compumedics Ltd. AH808 Somfit User Guide - Version 0 Page 2 of 54...

  • Page 3: Table Of Contents

    Document Title: Somfit User Guide Document Number: AH808 Table of Contents 1. Before You Begin ............6 Limited Warranty ............7 Limited Warranty - Electrode ......... 7 Intended Use ..............8 Intended Population ............8 Contraindications ............8 Labelling Definitions ............9 Warnings and Cautions ..........
  • Page 4 Document Title: Somfit User Guide Document Number: AH808 Apply Somfit ..............27 Open App - Start Recording .......... 27 Go to sleep ..............30 Wake ................31 4. Service and Maintenance ........33 Cleaning instruction ............. 33 Periodic Maintenance and Inspection ......35 Disposal ...............
  • Page 5 Document Title: Somfit User Guide Document Number: AH808 AH808 Somfit User Guide - Version 0 Page 5 of 54...

  • Page 6: Before You Begin

    Document Title: Somfit User Guide Document Number: AH808 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.

  • Page 7: Limited Warranty

    Document Number: AH808 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. Compumedics’ sole obligation under this warranty will be to repair or replace, at its option, products that prove to be defective during the warranty period.

  • Page 8: Intended Use

    Document Title: Somfit User Guide Document Number: AH808 Intended Use The Somfit System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as brain, heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or neurological disorders.

  • Page 9: Labelling Definitions

    Document Title: Somfit User Guide Document Number: AH808 Labelling Definitions Where you see this symbol, it means “WARNING” or “CAUTION”. Failure to follow operating instructions could put the patient or operator at risk. Where you see this symbol on any device label it means “RF electromagnetic energy emitted for diagnosis or treatment”.
  • Page 10 Document Title: Somfit User Guide Document Number: AH808 This symbol indicates the Pressure limits within which the package can be kept and handled This symbol indicates the manufacturer of this medical device. 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 lot or batch within which the...
  • Page 11 Document Title: Somfit User Guide Document Number: AH808 This symbol indicates the degree of protection provided by an enclosure. In this case the first ‘2’ means that the protection against solid objects of IP22 dimension more than 12.5mm and the second ‘2’ means the enclosure protects against vertically falling water drops.

  • Page 12: Warnings And Cautions

    Document Title: Somfit User Guide Document Number: AH808 Warnings and Cautions This symbol, when used with the word WARNING, highlights a situation that is potentially harmful to the patient or operator. When used with the word CAUTION it highlights a condition which may lead to equipment damage, malfunction, or inaccurate operation.
  • Page 13 The equipment is not serviceable by the user and should be returned to Compumedics if any repair is required or there are changes to the performance of the device. CAUTION...
  • Page 14 Do not use Somfit electrode if the packaging is damaged. Do not re-use Somfit electrode. Keep Somfit out of reach of pets and children. Use only Compumedics supplied accessories with the Somfit. Be sure to read, understand and follow the instructions in this User Guide and others that come with the system and its components.

  • Page 15: Tips

    Document Title: Somfit User Guide Document Number: AH808 Tips Somfit electrode is snapped into the device. As there is no lead wire involved, the risk of accidental contact between the conductive parts is not applicable. There is no time required for the device to warm from the minimum storage temperature between uses until it is ready for intended use.

  • Page 16: Cybersecurity Tips

    7 Troubleshooting • Set a screen lock mechanism on any smartphone running the Somfit app for additional security • Contact Compumedics if the device label shows evidence of tampering AH808 Somfit User Guide - Version 0 Page 16 of 54...

  • Page 17: Installing The Application

    Compumedics technicians can be answered efficiently. You should also have this manual at hand. The service life for the device will be 7 years. Compumedics will provide service and support for Somfit for at least seven AH808 Somfit User Guide - Version 0...
  • Page 18 Document Title: Somfit User Guide Document Number: AH808 years after its purchase date. As a best practice, Compumedics suggests the electrode to be used before the indicated expiry date. When you call please provide the following information: ● The version of software, hardware and operating system being used.
  • Page 19 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 20: Product Overview

    Document Title: Somfit User Guide Document Number: AH808 2 . P r o d u c t O v e r v i e w 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.

  • Page 21: 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 recommended by Compumedics. AH808 Somfit User Guide - Version 0 Page 21 of 54...

  • Page 22: Somfit Electrode

    Document Title: Somfit User Guide Document Number: AH808 Somfit Electrode This is a single use medical grade electrode for measuring your brain waves and also holding the Somfit in place. This is also referred to as the Somfit sensor pad. Somfit Application This is loaded onto an android or iPhone and provides the user interface to start and manage the recording.

  • Page 23: Using The Somfit

    Document Title: Somfit User Guide Document Number: AH808 3 . U s i n g t h e S o m f i t The Somfit is designed to be worn overnight during sleep. It can be used for a single night, or multiple nights to provide your physician with additional data.

  • Page 24: Before Use

    Document Title: Somfit User Guide Document Number: AH808 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. AH808 Somfit User Guide - Version 0 Page 24 of 54...

  • Page 25: Prepare Forehead

    Document Title: Somfit User Guide Document Number: AH808 Prepare Forehead First you need to prepare the forehead. AH808 Somfit User Guide - Version 0 Page 25 of 54...

  • Page 26: Prepare Somfit

    Document Title: Somfit User Guide Document Number: AH808 Prepare Somfit Take the Somfit off the charger and attach it to the electrode that you have for the nights study. AH808 Somfit User Guide - Version 0 Page 26 of 54...

  • Page 27: Apply Somfit

    Document Title: Somfit User Guide Document Number: AH808 Apply Somfit Now apply the Somfit to your forehead. Open App - Start Recording Open the application on the phone. Make sure you are signed into your account and then you can start recording. AH808 Somfit User Guide - Version 0 Page 27 of 54...
  • Page 28 Document Title: Somfit User Guide Document Number: AH808 AH808 Somfit User Guide - Version 0 Page 28 of 54...
  • Page 29 Document Title: Somfit User Guide Document Number: AH808 Somfit will perform some prestart checks to ensure the best signal quality and user experience. The pre-start test checks for whether 1) The Somfit is nearby and the phone can connect to it 2) Somfit battery is sufficient for at least 9-hour recording 3) Somfit is on the forehead 4) Sufficient skin preparation has been done...

  • Page 30: Go To Sleep

    Document Title: Somfit User Guide Document Number: AH808 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. AH808 Somfit User Guide - Version 0 Page 30 of 54...

  • Page 31: Wake

    Document Title: Somfit User Guide Document Number: AH808 Wake When you want up you just use the phone and press end study. Once the study is stopped you can carefully remove the electrode and Somfit from the electrode then return it to the cradle. Data will automatically be uploaded to the Somfit server for analysis and review by your physician.
  • Page 32 Document Title: Somfit User Guide Document Number: AH808 AH808 Somfit User Guide - Version 0 Page 32 of 54...

  • Page 33: Service And Maintenance

    Document Title: Somfit User Guide Document Number: AH808 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.
  • Page 34 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. Temperature and humidity limits are found in section 6 – Specifications.

  • Page 35: Periodic Maintenance And Inspection

    Technical information such as diagrams and parts list are available on request from service@compumedics.com Disposal As the Somfit device does not store any patient data or information, there are no cybersecurity concerns with regards to its disposal. Since it constitutes electronic waste;...

  • Page 36: Associated Equipment

    Document Title: Somfit User Guide Document Number: AH808 5 . A s s o c i a t e d E q u i p m e n t Associated Device and Consumables The following may be identified by their labelling with below part number.

  • Page 37: Specifications

    Document Title: Somfit User Guide Document Number: AH808 6 . S p e c i f i c a t i o n s Regulatory compliance Compliance Verified: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-26 IEC 80601-2-61 Type: Class II equipment Applied parts: Type BF Degree of protection:...

  • Page 38: Power Supply

    3.7 VDC Lithium Battery Battery Charger input: 5 VDC (USB Type C) Charger: Any USB Type C charger that complies with IEC 60950 as recommended by Compumedics. Wireless Interface Type: Bluetooth Low Energy (BLE) 4.2 Transmit Power: < -6.0 dBm Frequency band: 2402.0 to 2483.5 MHz...
  • Page 39 Document Title: Somfit User Guide Document Number: AH808 Note: functional tester cannot be used to assess the accuracy of the pulse oximeter. See graph 1 and table 1 for test results obtained from an ISO 80601- 2-61 desaturation study. Table 1: Somfit Bias Graph 1: Desaturation Study Test Results AH808 Somfit User Guide - Version 0 Page 39 of 54...

  • Page 40: Heart Rate

    Document Title: Somfit User Guide Document Number: AH808 Heart Rate Resolution: 1 bpm Range: 25 bpm to 250 bpm Accuracy: 3 bpm or 3%, whichever is greater (compared to Masimo Radical-7® Pulse CO-Oximeter®) Sleeping position Range Front, back, left, right, upright Sound Range Envelope detected sound non...
  • Page 41 Document Title: Somfit User Guide Document Number: AH808 Input Impedance: > 24 MΩ at DC, > 18 MΩ at 10Hz Input bias current: < 500 pA CMRR: >100dB (5KΩ imbalance) Differential input ± 400mV voltage range: Resolution: 24 bits Noise: 7uV p-p Frequency Range: 0.5 –...

  • Page 42: 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. AH808 Somfit User Guide - Version 0...

  • Page 43: Electromagnetic Emissions Statement

    Document Title: Somfit User Guide Document Number: AH808 6.13 Electromagnetic Emissions Statement This product needs special precautions regarding EMC and needs to be put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
  • Page 44 Document Title: Somfit User Guide Document Number: AH808 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 45 Document Title: Somfit User Guide Document Number: AH808 This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. AH808 Somfit User Guide - Version 0 Page 45 of 54...
  • Page 46 Document Title: Somfit User Guide Document Number: AH808 Guidance and manufacture’s declaration – electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment –...
  • Page 47 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 Compliance...
  • Page 48 If the user of 40% U 40% U lines the COMPUMEDICS requires continued operation during IEC 61000-4-11 power mains interruptions, it (30% dip in U (30% dip in U is recommended that the COMPUMEDICS be powered for 0.5 sec...
  • Page 49 Document Title: Somfit User Guide Document Number: AH808 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 the device should assure that it is used in such an environment. Immunity 60601 Compliance...
  • Page 50 Document Title: Somfit User Guide Document Number: AH808 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 3 The product also complies with enclosure port immunity to RF wireless communication equipment as specified in table 9 of EN 60601-1-2:2015.
  • Page 51 Document Title: Somfit User Guide Document Number: AH808 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. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

  • Page 52: Troubleshooting

    7 . T r o u b l e s h o o t i n g If you experience a problem with your device, you should first try the following troubleshooting suggestions. If the problem cannot be solved, please contact your supplier or Compumedics. Problem Possible Cause...
  • Page 53 Document Title: Somfit User Guide Document Number: AH808 Someone else has Take the Somfit already connected device to the Somfit device. Bluetooth range of potential attacker repeat connection steps. No PPG waveform or Device Move the device SPO2 is displayed operating in direct away from direct sunlight or in a...
  • Page 54 Document Title: Somfit User Guide Document Number: AH808 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,...

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