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uneeg MEDICAL 24/7 EEG SUBQ User Manual

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24/7 EEG™ SUBQ
USER MANUAL

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Summary of Contents for uneeg MEDICAL 24/7 EEG SUBQ

  • Page 1 24/7 EEG™ SUBQ USER MANUAL...
  • Page 2 24/7 EEG™ SubQ PRODUCT OVERVIEW UNEEG SubQ (Implant) 24/7 EEG SubQ (Device) FIGURE A The 24/7 EEG™ SubQ (here- the electroencephalogram after named system) consists (EEG). of implantable and non-im- (FIGURE plantable parts It communicates with a non-implantable part, the The implantable part, the 24/7 EEG™...
  • Page 3 24/7 EEG™ SubQ recorded EEG data. The data clothing using the supplied are sent through a wireless attachment magnet, while link. the C1 variant is attached to clothing using a plastic clip. The device exists in two variants; one with a magnet In addition to EEG, the device inside (M1) and one with- measures and stores 3D ac-...
  • Page 4 24/7 EEG™ SubQ WARNINGS AND PRECAUTIONS IMPORTANT: Additional - Therapeutic ultrasound warnings and precautions induced close to the may appear in this user implant. manual. - Electrical current induced close to the implant (e.g. electro knife, electrocon- WARNINGS • The implant is not com- vulsive therapy).
  • Page 5 24/7 EEG™ SubQ • Seek medical guidance be- sary, check that the device fore entering environments is functioning. that could adversely affect • Only supplied accessories the implant. This includes, may be connected to the but is not limited to: device.
  • Page 6 24/7 EEG™ SubQ aged if exposed to extreme • Avoid dropping the device. pressure variations. Do not • Do not use water or clean- take part in extreme sport ing solutions to clean the activities such as parachute device. See ‘4.2 CLEANING’. jumping or diving deeper •...
  • Page 7 24/7 EEG™ SubQ USER MANUAL | ENGLISH |...

  • Page 8: Table Of Contents

    24/7 EEG™ SubQ CONTENTS 1. INTRODUCTION ......10 1.1 Intended use ......10 1.2 Contraindications.
  • Page 9 24/7 EEG™ SubQ 3.6 Charge the device ..... . 26 3.7 Check status ......28 3.8 Diary check mark .

  • Page 10: Introduction

    24/7 EEG™ SubQ 1. INTRODUCTION IMPORTANT: You should 1.1 INTENDED USE Measuring and recording of receive regular follow-up electrical activity of the brain related to the system from (EEG) through electrodes the responsible medical implanted subcutaneously professional. in the tissue between the skull and the skin.
  • Page 11 24/7 EEG™ SubQ and hemorrhagic disease. hobby that includes activity • If you, for mental or phy- imposing a high risk of trau- sical reasons, cannot or ma against the device or do not have the necessary the site of implantation (e.g. assistance, to properly martial art or boxing).

  • Page 12: Side Effects

    24/7 EEG™ SubQ mation, swelling, irritation 1.3 SIDE EFFECTS General side effects normally and itching) may appear associated with any surgical around the implant up to implantation procedure or lo- 3 weeks after the surgical cal anaesthesia also apply to procedure.
  • Page 13 24/7 EEG™ SubQ please contact the responsi- 1.4 AFTER THE SURGERY Do not shower or touch the ble medical professional. operated area the first 24 hours after the implantation. Approximately 1-2 weeks after the implantation, the Ensure that the area of the stitches can be removed, and implant is inspected for the device can be used.

  • Page 14: Device Description

    24/7 EEG™ SubQ 2. DEVICE DESCRIPTION 2.1 DEVICE PARTS The device consists of several parts ( FIGURE C Disc Receives EEG data from the implant. Indicates if the disc is connected to Connection light the implant. Long press (3 sec): turn on/off de- Power button vice.
  • Page 15 24/7 EEG™ SubQ FIGURE C USER MANUAL | ENGLISH |...

  • Page 16: Accessories

    24/7 EEG™ SubQ 2.2 ACCESSORIES WARNING Besides the device and this • Only connect the manual, the following acces- supplied accessories sories are supplied: to the device. • Charger, consisting of - Wall adapter - USB cable, 150 cm, with long-tip (8 mm) micro USB connector •...
  • Page 17 24/7 EEG™ SubQ USER MANUAL | ENGLISH |...

  • Page 18: How To Use

    24/7 EEG™ SubQ 3. HOW TO USE 3.1 TURN ON THE DEVICE 1. Press and hold the power Turning on/off Disconnected Turning on/o Turning on/o Disconnected Disconnected button for approx. 3 seconds until the ‘turning-on sound’ plays and the power button Signature (FIGURE Signature...

  • Page 19: Mount Device On Clothes

    24/7 EEG™ SubQ 3.2 MOUNT DEVICE ON CLOTHES • The device exists in two variants; M1 and C1. • M1 contains a magnet inside and is marked with a (FIGURE FIGURE F symbol • C1 does not contain a WARNING magnet.
  • Page 20 24/7 EEG™ SubQ 3.2.1 MOUNT WITH ATTACHMENT CLIP (only applicable for the C1 variant) 1. Choose an appropriate place on your clothes, e.g. shirt collar or bra strap. 2. Slide the device onto your clothes using the clip-arms (FIGURE G). Note: The clip version is non-magnetic and is safe...
  • Page 21 24/7 EEG™ SubQ 3.2.2 MOUNT WITH ATTACHMENT MAGNET (only applicable for the M1 variant) 1. Remove the attachment magnet from the device. 2. Choose an appropriate place on your clothes, e.g. shirt collar or bra strap. 3. Place the device on one side of the clothes and attach the attachment magnet from the other...

  • Page 22: Attach Adhesive Pads

    24/7 EEG™ SubQ 3.3 ATTACH ADHESIVE PADS 1. Wipe the skin of the im- plant site with a dry cloth. 2. Take an adhesive pad from the sheet (FIGURE FIGURE I I). Be careful to get both the adhesive pad and the protective paper.
  • Page 23 24/7 EEG™ SubQ Note: The device and sup- Do not use the adhesive pad plied adhesive pads are made for more than 24 hours. of non-allergenic materials. Only use each adhesive pad Nonetheless, in rare cases, once. skin irritation may occur. When you remove the disc Contact your responsible medical professional if the...

  • Page 24: Attach And Connect The Disc

    24/7 EEG™ SubQ 3.4 ATTACH AND CONNECT THE DISC 1. Hold the disc over the implant site WITHOUT attaching it to the skin (FIGURE L). When at the correct position, the con- FIGURE L nection light turns green for 10 seconds, and the Connected Recording ‘connection sound’...

  • Page 25: Turn Off The Device

    24/7 EEG™ SubQ Turning on/o Disconnect 3.5 TURN OFF THE DEVICE Turning on/off 1. Press and hold the power button for approx. 3 seconds until the device Signature turns off. The ‘turning-off sound’ plays, and the Sound power button blinks green Turns off Vibration after 3 min...

  • Page 26: Charge The Device

    24/7 EEG™ SubQ You can find the lights and 3.6 CHARGE THE DEVICE sounds associated with charging and low battery WARNING TABLE 1. levels in • Only use the supplied charger for charging the The device should be device. charged whenever it is not •...
  • Page 27 24/7 EEG™ SubQ Error or Low battery Very low battery Chargin ow battery Charging Fully charged Charging Fully charged Low battery Very low battery Data storage full Turns off after 30 seconds Every Every Every 30 min 5 min 5 min Once FIGURE P FIGURE Q...

  • Page 28: Check Status

    24/7 EEG™ SubQ Note: The device only works 3.7 CHECK STATUS when it is correctly connect- To check that the device ed to the implant. Loss of works correctly: connection results in missing 1. Short press the power data. button. TABLE 2.
  • Page 29 24/7 EEG™ SubQ Symbols: Vibration Sound Symbols: Vibration Sound Symbols: Vibration Sound Turning on/o Disconnected Connected Recording Diary check mark Turning on/o Disconnected Connected Recording Diary check mark Turning on/off Disconnected Connected Recording Diary check mark Turning on/o Disconnected Connected Recording Diary check mark On 10 sec...

  • Page 30: Diary Check Mark

    24/7 EEG™ SubQ 3.8 DIARY CHECK MARK To mark an event in the EEG Vibration Sound data as advised by your Diary check mark Disconnected Connected Recording Diary check mark medical professional: On 10 sec On 3 sec 1. Double press the power button.
  • Page 31 24/7 EEG™ SubQ USER MANUAL | ENGLISH |...

  • Page 32: Maintenance

    24/7 EEG™ SubQ 4. MAINTENANCE The device is a valuable PRECAUTION medical device and should • Do not wear the device be treated with care. This in the shower or when section contains information swimming. on how to handle it. •...

  • Page 33: Cleaning

    24/7 EEG™ SubQ The cleaning process is as 4.2 CLEANING To keep the device hygienic, follows: it is recommended to clean it 1. Make sure that the device at least once per week. is turned off, that the disc has been removed from the head, and that the PRECAUTION adhesive pad has been...

  • Page 34: Disposal

    24/7 EEG™ SubQ 4.3 DISPOSAL 4.4 MALFUNCTIONING DEVICES The device and all electronic If the device seems to be accessories must be malfunctioning, contact your disposed of in accordance responsible medical profes- with the (WEEE) EU sional. Directive 2012/19/EU. PRECAUTION This means that the device •...

  • Page 35: Lifetime Of Implant

    24/7 EEG™ SubQ 4.5 LIFETIME OF IMPLANT 4.7 TRAVELLING The implant has a lifetime of It is okay to move through 15 months after implantation. metal detectors and full-body Before this period expires, scanners with the implant, but the implant must be the device should be unmount- explanted.

  • Page 36: Troubleshooting

    24/7 EEG™ SubQ 5. TROUBLESHOOTING TABLE 4 for information For further assistance regard- on how to react in different ing device use or unexpected situations. events, contact the responsi- ble medical professional. TABLE 4: TROUBLESHOOTING PROBLEM POSSIBLE CAUSE POSSIBLE SOLUTION The power button The device is low on Charge the battery.

  • Page 37: Technical Description

    24/7 EEG™ SubQ 6. TECHNICAL DESCRIPTION Intended Performance Repairs The 24/7 EEG™ SubQ records The device contains no re- EEG. placeable or repairable parts. Power Source Environmental Conditions The device may only be The following are the allowed charged by an IEC 60950-1 environmental conditions for compliant power source.
  • Page 38 24/7 EEG™ SubQ Specifications & Characteristics The system consists of the following parts: 24/7 EEG™ SubQ Device Length: 89.9 mm. / Width: 37.5 mm. Thickness (without Attachment Magnet): 10.9 mm. Thickness (with Attachment Magnet): 15.6 mm. Polycarbonate/Acrylonitrile Butadiene Styrene (PC ABS).
  • Page 39 24/7 EEG™ SubQ UNEEG™ SubQ (implant) House 24x17x3.3 mm. Ceramic, titanium, silicone, tungsten, gold and ruby feed. Lead 103 mm. Silicone. 3 contact points. Contact points Outer diameter: 1.06 mm. Length: 10 mm. Pt-Ir. USER MANUAL | ENGLISH |...
  • Page 40 24/7 EEG™ SubQ Device RF reception Charger specifications: Manufacturer ARTESYN 1.0606 MHz Model DA5-050EU 30 kHz Device RF transmission specifications: 1.0606 MHz Modulation Load modulation (ASK) Data 8.3k bit/s Manchester encoded 25 kHz 73 dBm | USER MANUAL | ENGLISH...
  • Page 41 24/7 EEG™ SubQ Immunity PHENOMENON TEST METHOD IMMUNITY TEST LEVEL Electrostatic discharge EN 61000-4-2 +/- 8 kV contact immunity +/- 2, 4, 8, 15 kV air Electrostatic discharge EN 61000-4-2 +/- 8 kV contact immunity - patient +/- 2, 4, 8, 15 kV air coupling ports Electrostatic discharge EN 61000-4-2...
  • Page 42 24/7 EEG™ SubQ PHENOMENON TEST METHOD IMMUNITY TEST LEVEL Electrical fast transient/ EN 61000-4-4 +/- 2 kV burst immunity +100 kHz repetition frequency - AC power ports Electrical fast transient/ EN 61000-4-4 Not applicable burst immunity - DC power ports Electrical fast transient/ EN 61000-4-4 Not applicable...
  • Page 43 24/7 EEG™ SubQ PHENOMENON TEST METHOD IMMUNITY TEST LEVEL Immunity to conducted EN 61000-4-6 Not applicable disturbances induced by RF fields - I/O SIO/SOP ports Immunity to conducted EN 61000-4-6 Not applicable disturbances induced by RF fields - Patient coupling ports Power frequency EN 61000-4-8...
  • Page 44 24/7 EEG™ SubQ Emissions PHENOMENON TEST METHOD CLASS GROUP Conducted RF emissions EN 55011 Class B Group 1 Radiated RF emissions EN 55011 Class B Group 1 Harmonic current emissions EN 61000-3-2 Class A Voltage changes, voltage EN 61000-3-3 fluctuations and flicker emissions | USER MANUAL | ENGLISH...
  • Page 45 24/7 EEG™ SubQ USER MANUAL | ENGLISH |...

  • Page 46: Symbols And Markings

    24/7 EEG™ SubQ 7. SYMBOLS AND MARKINGS Explanation of symbols found on products and on packaging: Manufacturer Date of manufacture Use-by date Batch number Catalogue number Serial number CE marking: Declaration that the product meets all the safety, health, and environmental protection requirements for CE marking and can be sold throughout the EEA.
  • Page 47 24/7 EEG™ SubQ Not for general waste Warning: Messages with this heading indicate serious adverse reactions, potential safety hazards and inadequate performance of device. Consult instructions for use Temperature limits Humidity limits IP24 Ingress protection rating BF type applied part Warning: Magnetic field.
  • Page 48 Nymøllevej 6 3540 Lynge Denmark www.uneeg.com 0344 2019 © 2020 UNEEG™ medical 2020/06 Rev. IFU-10005-8...

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