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24/7 EEG™ SubQ

12

| USER MANUAL | ENGLISH

1.3 SIDE EFFECTS

General side effects normally
associated with any surgical
implantation procedure or lo-
cal anaesthesia also apply to
the placement of the implant.

Specifically, you may ex-
perience the following side
effects with the implantation
and use of the system:
• Up to 3 weeks after the

surgical procedure, haema-
toma or seroma may
appear near the implant.

• Temporary pain, headache,

infection and discomfort
(including soreness, inflam-

mation, swelling, irritation
and itching) may appear
around the implant up to
3 weeks after the surgical
procedure.

• Damaged blood circulation

and pressure to the skin
around the implant may
result in damaged tissue.

• Infection, swelling, soreness,

irritation or itching of the
skin around the implant.

• Occasional headache or

pain during long-term use
of the system.

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Содержание SUBQ

Страница 1: ...24 7 EEG SUBQ USER MANUAL ...

Страница 2: ...mplantable and non im plantable parts FIGURE A The implantable part the UNEEG SubQ hereafter named implant is implanted under the skin and measures PRODUCT OVERVIEW the electroencephalogram EEG It communicates with a non implantable part the 24 7 EEG SubQ hereafter named device which sup plies the implant with power and receives and stores the ...

Страница 3: ... net symbol FIGURE B Subjects with other active implantable devices must consult their responsible medical professional before using the M1 variant The M1 variant is attached to clothing using the supplied attachment magnet while the C1 variant is attached to clothing using a plastic clip In addition to EEG the device measures and stores 3D ac celeration to support future product development These...

Страница 4: ...ore receiving any of the following treatments MRI scan The implant is MR unsafe Therapeutic ionizing radiation induced close to the implant e g radiation therapy for cancer Therapeutic ultrasound induced close to the implant Electrical current induced close to the implant e g electro knife electrocon vulsive therapy The following medical pro cedures are safe to use with the implant Diagnostic ioni...

Страница 5: ...ec tronic equipment including radio frequency communi cations equipment might result in improper opera tion If such use is neces sary check that the device is functioning Only supplied accessories may be connected to the device Keep device and accesso ries out of reach of children PRECAUTIONS When you use the device take note of the following The implant can be da maged if exposed to physical impa...

Страница 6: ...jury contact the responsible medical professional Hold mobile phone to the opposite ear from the implant site The device contains personal data Take precautions not to lose the device Do not wear the device in the shower or when swim ming Avoid dropping the device Do not use water or clean ing solutions to clean the device See 4 2 CLEANING Do not sink the device into any liquid including alcohol D...

Страница 7: ...24 7 EEG SubQ USER MANUAL ENGLISH 7 ...

Страница 8: ...use 10 1 2 Contraindications 10 1 3 Side effects 11 2 DEVICE DESCRIPTION 14 2 1 Device parts 14 2 2 Accessories 16 3 HOW TO USE 18 3 1 Turn on the device 18 3 2 Mount device on clothes 19 3 3 Attach adhesive pads 22 3 4 Attach and connect the disc 24 3 5 Turn off the device 25 ...

Страница 9: ...atus 28 3 8 Diary check mark 30 4 MAINTENANCE 32 4 1 Handling 32 4 2 Cleaning 33 4 3 Disposal 34 4 4 Malfunctioning devices 34 4 5 Lifetime of implant 35 4 6 Maintenance of device 35 4 7 Travelling 35 5 TROUBLESHOOTING 36 6 TECHNICAL DESCRIPTION 37 7 SYMBOLS AND MARKINGS 46 ...

Страница 10: ...n monitoring and diagnosis of diseases or conditions that alter the EEG The intended users of the product are males and females age 18 and above IMPORTANT You should receive regular follow up related to the system from the responsible medical professional 1 2 CONTRAINDICATIONS The system should not be used in the following cases If you have cochlear im plant s If you receive therapy with medical d...

Страница 11: ...tion where the implant should be placed If you operate MRI scanners If you have a profession hobby that includes activity imposing extreme pressure variations e g diving or parachute jumping NB diving snorkelling is allowed to 5 metres depth If you have a profession hobby that includes activity imposing a high risk of trau ma against the device or the site of implantation e g martial art or boxing...

Страница 12: ... weeks after the surgical procedure haema toma or seroma may appear near the implant Temporary pain headache infection and discomfort including soreness inflam mation swelling irritation and itching may appear around the implant up to 3 weeks after the surgical procedure Damaged blood circulation and pressure to the skin around the implant may result in damaged tissue Infection swelling soreness i...

Страница 13: ...t is inspected for signs of infection daily The following might be signs of infection Redness Heat Pain Swelling If one or more of these signs of infection appear or if you are in doubt whether everything is as it should be please contact the responsi ble medical professional Approximately 1 2 weeks after the implantation the stitches can be removed and the device can be used ...

Страница 14: ...sc is connected to the implant Power button Long press 3 sec turn on off de vice Double press diary check mark Short press check device status Charging light Indicates if the device is charging Charger port Insert the charger here Attachment clip only for C1 Used for attaching the C1 device on the clothes Attachment magnet only for M1 Used for attaching the M1 device on the clothes 1 2 3 4 5 6 7 ...

Страница 15: ...24 7 EEG SubQ USER MANUAL ENGLISH 15 FIGURE C 1 2 3 4 5 6 7 ...

Страница 16: ...Besides the device and this manual the following acces sories are supplied Charger consisting of Wall adapter USB cable 150 cm with long tip 8 mm micro USB connector Cleaning cloth Adhesive pads WARNING Only connect the supplied accessories to the device ...

Страница 17: ...24 7 EEG SubQ USER MANUAL ENGLISH 17 ...

Страница 18: ...onnection light blinks white and the device vibrates and plays the disconnected sound every 10 seconds FIGURE E FIGURE D FIGURE E Turning on off Disconnected Error or Data storage full Very low battery Low battery Disconnected Turning on off Sound Signature Vibration Turns off after 3 min Turns off Error or Data storage full C Very low battery Low battery Disconnected Turning on off Sound Signatur...

Страница 19: ...in a magnet M1 is attached to clothing using a second magnet while C1 is attached to clothing using a plastic clip WARNING The magnetic field from the M1 device might disturb other active implantable devices e g pacemakers If you have another active implanta ble device consult your responsible medical pro fessional before use 3 2 MOUNT DEVICE ON CLOTHES FIGURE F ...

Страница 20: ... 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 to mount near implantable devices FIGURE G ...

Страница 21: ...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 side FIGURE H FIGURE H ...

Страница 22: ...he sheet FIGURE I Be careful to get both the adhesive pad and the protective paper If the ad hesive pad does not let go use a fingernail or similar 3 Attach the adhesive pad to either side of the disc FIGURE J 4 Remove the protective paper from the adhesive pad FIGURE K Make sure that the adhesive pad stays on the disc FIGURE I FIGURE K FIGURE J ...

Страница 23: ...gernail to remove the adhesive pad from the disc For any glue residue on the disc see 4 2 CLEANING For any difficulties attaching the adhesive pad to the skin try cleaning the skin with an alcohol swab Note The device and sup plied adhesive pads are made of non allergenic materials Nonetheless in rare cases skin irritation may occur Contact your responsible medical professional if the problem is p...

Страница 24: ...move your head If the wire is too short try moving the device Note the device is silent with no lights while recording EEG FIGURE N FIGURE L FIGURE M On 10 sec Connected Error or ata storage full Fully charged Charging Very low battery Low battery Disconnected Turning on off Sound Signature Vibration Turns off after 3 min FIGURE N Recording Error or Data storage full Fully charged Charging Very lo...

Страница 25: ...onds until the device turns off The turning off sound plays and the power button blinks green once FIGURE O FIGURE O Turning on off Error or Data storage full Very low batte Low battery Disconnected Turning on off Sound Signature Vibration Turns off after 3 min Every 30 min Every 5 min Turns off after 30 seconds ...

Страница 26: ... device charger port 2 Insert the other end of the charger into a regular power socket You can find the lights and sounds associated with charging and low battery levels in TABLE 1 The device should be charged whenever it is not in use The battery life when fully charged is minimum 24 hours Note If the device is not fully charged at least every 30 days the internal clock might become incorrect Not...

Страница 27: ...y 30 minutes FIGURE R Very low battery Power button and charging light blink yellow The low battery sound plays every 5 minutes FIGURE S FIGURE P TABLE 1 CHARGING AND BATTERY LEVEL FIGURE R FIGURE S FIGURE Q Low battery Very low battery Fully charged Charging Fully charged Charging y low battery Every 5 min Once Error or Data storage full Charging Very low battery Low battery Every 30 min Every 5 ...

Страница 28: ...ee FIGURE T Turned on and con nected to implant The connection light is green for 4 seconds The connection sound plays Low battery The power button and charging light are yellow for 4 seconds The connection sound plays Turned off No sound or lights TABLE 2 STATUS Note The device only works when it is correctly connect ed to the implant Loss of connection results in missing data D T D T D D ...

Страница 29: ...ected Turning on off Diary check mark Sound Symbols Vibration Turns off after 3 min Device is silent while recording On 3 sec On 10 sec Every 30 min Every 5 min Once Turns off after 30 seconds Error or Data storage full Fully charged Charging Very low battery Low battery Recording Connected Disconnected Turning on off Diary check mark Sound Symbols Vibration Turns off after 3 min Device is silent ...

Страница 30: ...ARK To mark an event in the EEG data as advised by your medical professional 1 Double press the power button Note that diary check mark is only possible when device is turned on see TABLE 3 full Fully charged Charging Very low battery Low battery Recording Connected Disconnected off Diary check mark Sound Vibration Turns off after 3 min Device is silent while recording On 3 sec On 10 sec Every 30 ...

Страница 31: ...24 7 EEG SubQ USER MANUAL ENGLISH 31 ...

Страница 32: ... information on how to handle it 4 1 HANDLING Make sure that the device does not get wet and dry it thoroughly with a cloth or similar after heavy perspira tion e g after intense physi cal activity See environmental conditions in 6 TECHNICAL DESCRIP TION PRECAUTION Do not wear the device in the shower or when swimming Avoid dropping the device ...

Страница 33: ...ohol For cleaning the device you can use the following Denatured alcohol ethanol Hand disinfection gel Provided cleaning cloth The cleaning process is as follows 1 Make sure that the device is turned off that the disc has been removed from the head and that the adhesive pad has been removed 2 Apply alcohol to the clean ing cloth 3 Rub all surfaces of the device including the cable and disc 4 Wait ...

Страница 34: ...the WEEE EU Directive 2012 19 EU This means that the device and all electronic accessories should be handed in for recycling rather than discarded with household waste 4 4 MALFUNCTIONING DEVICES If the device seems to be malfunctioning contact your responsible medical profes sional PRECAUTION Do not try to open or repair the device ...

Страница 35: ...7 TRAVELLING It is okay to move through metal detectors and full body scanners with the implant but the device should be unmount ed and turned off before you move through a metal detec tor Treat the device as elec tronic hand luggage when you go through any security checks You can use the device during flight but the airline company s guidelines for electronic equip ment should be followed This mi...

Страница 36: ...vice The power button and connection light are red The device has en countered an error Contact the responsible medical professional Data storage is full Contact the responsible medical professional The device does not turn on The device is either low on battery OR has encountered an error First try charging the battery See 3 6 Charge the device If the device still does not turn on contact the res...

Страница 37: ...to the medical device Modification No modification of the equip ment is allowed Repairs The device contains no re placeable or repairable parts Environmental Conditions The following are the allowed environmental conditions for the device and accessories 6 TECHNICAL DESCRIPTION Pressure 70 kPa 3000 m above sea level to 150 kPa 5 m below sea level Relative Humidity 10 to 95 Temperature 0 C to 40 C ...

Страница 38: ...ycarbonate Acrylonitrile Butadiene Styrene PC ABS Material grade Sabic CYCOLOY HC1204HF Weight without Attachment Magnet and wire 37 1 g Disc Diameters 15 9 x 20 4 mm Thickness 3 mm Moulded in epoxy Weight with wire 2 9 g Wire Length 360 mm Outer diameter 1 4 mm Cable silicone Bend reliefs Polyamide PA Specifications Characteristics The system consists of the following parts ...

Страница 39: ...bQ USER MANUAL ENGLISH 39 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 ...

Страница 40: ...ice RF reception specifications Fc 1 0606 MHz RBW 30 kHz Manufacturer ARTESYN Model DA5 050EU Device RF transmission specifications Fc 1 0606 MHz Modulation Load modulation ASK Data 8 3k bit s Manchester encoded OBW 25 kHz ERP 73 dBm Charger ...

Страница 41: ...7 V m 18 Hz PM 50 duty cycle square wave 450 Mhz 28 V m FM 5 kHz dev 1 kHz sine 710 MHz 9 V m 217 Hz PM 50 duty cycle square wave 745 MHz 9 V m 217 Hz PM 50 duty cycle square wave 780 MHz 9 V m 217 Hz PM 50 duty cycle square wave 810 MHz 28 V m 18 Hz PM 50 duty cycle square wave 870 MHz 28 V m 18 Hz PM 50 duty cycle square wave 930 MHz 28 V m 18 Hz PM 50 duty cycle square wave 1720 MHz 28 V m 217 ...

Страница 42: ...000 4 4 Not applicable Surge immunity AC power ports EN 61000 4 5 Line to line 0 5 1 kV line to line Line to ground Not applicable the system is a Class II device Surge immunity DC power ports EN 61000 4 5 Not applicable Surge immunity I O SIO SOP ports EN 61000 4 5 Not applicable Immunity to conducted disturbances induced by RF fields AC power ports EN 61000 4 6 3 V 6 V in ISM bands and amateur r...

Страница 43: ... 5 cycle at 0 90 135 180 225 270 and 315 0 UT 1 cycle at 0 70 UT 10 cycle at 0 0 UT 25 cycle at 0 Electrical transient conduction along supply lines ISO 7637 2 Not applicable a The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 5 67 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz a...

Страница 44: ...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 fluctuations and flicker emissions EN 61000 3 3 ...

Страница 45: ...24 7 EEG SubQ USER MANUAL ENGLISH 45 ...

Страница 46: ... 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 ...

Страница 47: ...ndicate 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 Do not bring device near implants sensitive to magnetic fields ...

Страница 48: ...UNEEG medical A S Borupvang 2 DK 3450 Allerød www uneeg com 0344 2019 2021 11 Rev LTX10021 11 2020 UNEEG medical ...

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