Somfit USER GUIDE
AH808-0 Part Number: 8040-0001-00 © Compumedics Ltd Document No. AH808 Issue 0 Release date 19 August 2019 Language 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.
Table of Contents 1. Before You Begin ..................................................... 1 1.1 Limited Warranty .......................................................... 2 1.2 Limited Warranty - Electrode ........................................ 2 1.3 Intended Use ................................................................ 3 1.4 Intended Population ..................................................... 3 1.5 Contraindications.......................................................... 3 1.
. Service and Maintenance ..................................... 27 4.1 Cleaning instruction .................................................... 27 4.2 Periodic Maintenance and Inspection ......................... 29 5. Associated Equipment ......................................... 31 5.1 Associated Device ...................................................... 31 5.2 Related Equipment ..................................................... 32 6. Specifications ........................................
CHAPTER 1 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. Failures to comply with these instructions may result in damage to device, device contents.
Chapter 1 Before You Begin Limited Warranty 1.1 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. The foregoing shall be the sole warranty remedy.
Before You Begin 1.3 Chapter 1 Intended Use The Somfit System is intended to help maintain and encourage a general state of health and/or healthy sleep. Somfit is for users who are interested in understanding their sleep architecture derived from a measure of brain waves (EEG), functional oxygen saturation (SpO2), heart rate, relative sound in the environment (including snoring), light intensity and sleeping position overnight.
Chapter 1 1.6 Before You Begin 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 “Class II Equipment”. Where you see this symbol on any device label it means “RF electromagnetic energy emitted for diagnosis or treatment”. Where you see this symbol, it means “Refer to operating instructions is advisory”.
Before You Begin Chapter 1 This symbol indicates the temperature limits within which the package can be kept and handled This symbol indicates the Humidity limits within which the package can be kept and handled This symbol indicates the Pressure limits within which the package can be kept and handled This symbol indicates the manufacturer of this medical device.
Chapter 1 IP22 Before You Begin This symbol indicates the degree of protection provided by an enclosure. In this case the X means that the protection against solid objects is not specified and the 1 means the enclosure protects against vertically falling water drops.
Before You Begin 1.7 Chapter 1 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. WARNING The Somfit is not intended to diagnose any medical condition. Do not use the Somfit during Magnetic Resonance Imaging (MRI) or in an MRI environment.
Chapter 1 Before You Begin 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. Do not use the Somfit while charging or when inadequately charged. Do not use the Somfit if forehead skin shows irritation or damage. Keep Somfit out of reach of pets and children.
Before You Begin 1.8 Chapter 1 Tips When using the Somfit with a smart device (smartphone, tablet computer), keep both devices within the recommended range of each other. Moving outside of this range may cause a loss of connection with the smart device. 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.
Chapter 1 Before You Begin 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. If you are unable to find the answer in this User Guide contact Compumedics Product Support on: Australia New Zealand USA International 1800 244 773 0800 888 015 877 294 1346 +61 3 8420 7396 or your authorised representative.
Before You Begin Chapter 1 Repairs of Compumedics Limited equipment under warranty or service contracts must be made at authorised repair centres. If the equipment needs repair, contact Compumedics Limited service department to request an RA Number (Return Authorisation). When calling have the device model and serial number ready. Service items received without an RA number may be returned to the sender or remain un-repaired until a number is raised.
Chapter 1 Before You Begin Compumedics Service Addresses Compumedics Ltd 30 – 40 Flockhart Street Abbotsford, VIC, 3067 Australia Phone: +61 3 8420 7300 Fax: +61 3 8420 7399 Compumedics USA 5015 W W.T. Harris Blvd. Suite E Charlotte, NC 28269 USA Phone: +1 704 749 3200 Fax: +1 704 749 3299 Compumedics Germany GmbH Werdauer Str.1-3, 01069 Dresden, Germany Phone: +49 7731 79 769 0 Fax: +49 7731 79 769 99 Compumedics E-Mail Address Compumedics can also be contacted by sending e mail via the Internet.
CHAPTER 2 2. Product Overview The Somfit system consists of four components that the user can interact with. 2.1 Somfit device This is the actual Somfit device that does the recording and transmission of the data which represents your sleep signals.
Chapter 2 2.2 Product Overview 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.
Product Overview 2.3 Chapter 2 Somfit electrode This is a single use medical grade electrode for measuring your brain waves and also holding the Somfit in place. 2.4 Somfit application This is loaded onto an android or iPhone and provides the user interface to start and manage the recording.
Chapter 2 Product Overview This page is intentionally blank Page 16 Somfit Installation and User Guide © Compumedics Ltd 2019
CHAPTER 3 3. Using the Somfit 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.
Chapter 3 3.1 Using the Somfit 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.
Using the Somfit 3.2 Chapter 3 Prep Forehead First you need to prepare the forehead.
Chapter 3 3.3 Using the Somfit Prep Somfit Take the Somfit off the charger and attach it to the electrode that you have for the nights study.
Using the Somfit 3.4 Chapter 3 Apply Somfit Now apply the Somfit to your forehead. 3.5 Open App Open the application on the phone. Make sure you are signed into your account and then you can start recording.
Chapter 3 Using the Somfit Page 22 Somfit Installation and User Guide © Compumedics Ltd 2019
Using the Somfit 3.6 Chapter 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.
Chapter 3 3.7 Using the Somfit Wake When you want up you just use the phone and press end study.
Using the Somfit Chapter 3 Once the study is stopped you can carefully remove the electrode and Somfit from the electrode then return it to the cradle.
Chapter 3 3.8 Using the Somfit 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.
CHAPTER 4 4. Service and Maintenance 4.1 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. Preparation for cleaning: Remove any cables that are attached to the instruments. Cleaning internal components is not necessary. Do not disassemble the instruments. Cleaning (Manual): Clean the surfaces with a damp cloth and mild detergent. Note: Do not immerse in liquids.
Chapter 4 Service and Maintenance Note: Do not soak or wet internal components. Drying: Remove excess moisture from the instrument with a clean, absorbent, and non-shedding wipe. Maintenance: Inspect the device to ensure all visible contamination has been removed. Visually inspect for completeness, damage, and/or excessive wear. Sterilisation: Do not sterilise. Packaging: The device does not require packaging. Storage: There is no specific storage requirement for this device.
Service and Maintenance 4.2 Chapter 4 Periodic Maintenance and Inspection No regular maintenance or calibration is required for this device, although a regular annual inspection is recommended. Grounding continuity, leakage current and isolation should be checked periodically by a qualified technician. Where appropriate such tests should conform to any standard applicable to the country in installation. Inspection should also consist of checking than any plugs are engaged and not damaged.
Chapter 4 Service and Maintenance This page is intentionally blank Page 30 Somfit Installation and User Guide © Compumedics Ltd 2019
CHAPTER 5 5. Associated Equipment 5.
Chapter 5 5.2 Associated Equipment Related Equipment Equipment such as computers, surveillance cameras and network switches are released with very short update cycles. As such specific model numbers may be available for less than twelve month and, as such, cannot be listed here. 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.
CHAPTER 6 6. Specifications 6.1 6.
Chapter 6 6.3 6.4 6.5 6.6 Operating Conditions Temperature range: 0°C (+32°F) to 40°C (+104°F) Humidity: 20 to 90% RH (non-condensing) Atmospheric pressure: 70 kPa to 106 kPa Altitude: Less than 3,000 m Functional Oxygen Saturation Resolution: 1% Measurement Range: 70% to 100% Accuracy: <= 3.5% Heart Rate Resolution: 1 bpm Range: 25 bpm to 250 bpm Accuracy: 3 bpm or 3%, whichever is greater Sleeping position Range 6.
Chapter 6 Specifications 6.8 Light Range 6.9 Indication of relative light EEG Number: 2 differentials Type: 2 Channels with three electrodes.
Chapter 6 Specifications 6.10 Environmental Protection WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic equipment. These devices should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region.
Chapter 6 Specifications 6.11 Electromagnetic Emissions Statement This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
Chapter 6 Specifications This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Specifications Chapter 6 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.
Chapter 6 Specifications 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. Immunity test Electrostatic discharge (ESD) IEC 60601 test level Compliance level ±8 kV contact ±8 kV contact ±15 kV air ±15 kV air Electrical fast transient/burst ±2 kV for a.c. Power Ports ±2kV for a.c.
Chapter 6 Specifications Voltage dips, short interruptions and voltage variations on power supply input lines >95% dip in UT >95% dip in UT for 1 cycle for 1 cycle 40% UT 40% UT (30% dip in UT) (30% dip in UT) for 0.5 sec for 0.5 sec >95% dip in UT >95% dip in UT for 5 sec for 5 sec 30 A/m 30 A/m IEC 61000-4-11 Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 Mains power quality should be that of a typical commercial or hospital environment.
Chapter 6 Specifications 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.
Specifications NOTE 1 Chapter 6 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.
Chapter 6 Specifications 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.
Specifications Chapter 6 This page is intentionally blank Somfit Installation and User Guide © Compumedics Ltd 2019 Page 45
For more information please contact: Compumedics Limited, Australia: Compumedics USA, Inc.
