uneeg MEDICAL 24/7 EEG SUBQ, User Manual

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

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