uneeg MEDICAL 24/7 EEG SUBQ Скачать руководство пользователя страница 12 | Manualshive

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uneeg MEDICAL 24/7 EEG SUBQ Скачать руководство пользователя страница 12

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 24/7 EEG SUBQ

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

Страница 2: ...plantable 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 comm...

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 supp...

Страница 4: ...re 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 induc...

Страница 5: ...c 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...

Страница 6: ...ury 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 d...

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

Страница 8: ...se 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 ad...

Страница 9: ...tus 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...

Страница 10: ...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 t...

Страница 11: ...ion 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...

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 ma...

Страница 13: ...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 everyth...

Страница 14: ...c 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...

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

Страница 16: ...esides 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 WARNIN...

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

Страница 18: ...disc the connection light blinks white and the device vibrates and plays the dis connected sound every 10 seconds FIGURE E FIGURE D FIGURE E Turning on off Disconnected Error or Data storage full Very...

Страница 19: ...n 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 d...

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 i...

Страница 21: ...nly 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 cloth...

Страница 22: ...e 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...

Страница 23: ...ernail 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...

Страница 24: ...y 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 storage full Fully...

Страница 25: ...conds 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 bat Low battery Disconnect Turn...

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...

Страница 27: ...ry 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...

Страница 28: ...ion see 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...

Страница 29: ...cted 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...

Страница 30: ...K MARK 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 l Fully...

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...

Страница 33: ...hol 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 o...

Страница 34: ...he 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...

Страница 35: ...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 de...

Страница 36: ...ice 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 Th...

Страница 37: ...o 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 en...

Страница 38: ...carbonate 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 We...

Страница 39: ...Q 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...

Страница 40: ...ce 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 Manchest...

Страница 41: ...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...

Страница 42: ...00 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...

Страница 43: ...le at 0o 90o 135o 180o 225o 270o and 315o 0 UT 1 cycle at 0o 70 UT 10 cycle at 0o 0 UT 25 cycle at 0o Electrical transient conduction along supply lines ISO 7637 2 Not applicable a The ISM industrial...

Страница 44: ...HENOMENON 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...

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 envi...

Страница 47: ...dicate 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 ap...

Страница 48: ...Nym llevej 6 3540 Lynge Denmark www uneeg com 0344 2019 2020 06 Rev IFU 10005 8 2020 UNEEG medical...

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