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Instructions for Use

03

Instructions for Use

EN

   Rev. 2021-07-01    

OkuStim

 System   

TD60K06 -

OkuStim

® System

Содержание OkuStim

Страница 1: ...Instructions for Use 03 Instructions for Use EN Rev 2021 07 01 OkuStim System TD60K06 OkuStim System...

Страница 2: ...OkuStim system is intended for electrical stimulation of the retina of patients suffering from retinitis pigmentosa in an outpatient or home environment Users and Places of Use The OkuStim system is...

Страница 3: ...ion Serial number Use by date Date of manufacture Manufacturer Packaging unit Not for reuse Sample for temperature range The CE identification documents agreement with the Medical Device Directive 93...

Страница 4: ...tified USB cable with electrical safety according to EN60601 1 3rd ed with 4kVrms to connect the OkuStim device with a PC with the USB plug type B The device must not be opened or modified During an e...

Страница 5: ...clinical findings that could be worsened by the therapy in patients with active implants2 in case of current pregnancy whilst breastfeeding in case of acute eye inflammation Conditions for the applic...

Страница 6: ...to Performing a Therapy Session 12 5 Use 13 5 1 Adapting the OkuSpex to the Patient 13 5 2 Attaching the OkuEl Counter Electrodes to the Body 14 5 3 Opening the OkuEl Electrode Package 14 5 4 Insertin...

Страница 7: ...aning Disinfection and Care of the OkuSpex 26 11 2 Cleaning and Care of the OkuStim 26 11 3 OkuEl Electrodes and OkuEl Counter Electrodes 26 12 Repair and Maintenance 26 13 Troubleshooting 27 13 1 Dis...

Страница 8: ...etina that have a protective effect on retinal cells This neuropro tective effect can maintain physiological functions in the retina for longer and slow down the retinal degeneration In TES therapy re...

Страница 9: ...stimulated with the pre set para meters over a time of 30 minutes During the stimulation the perception of white and bright light sensations so called phosphenes is probable The individual treatment...

Страница 10: ...dheld device on the product label OkuStim OkuSpex frame with cable OkuEl electrode package on the product label OkuEl Electrode Package contains 10 OkuEl electrodes on the product label OkuEl Electrod...

Страница 11: ...introduction and have your therapy para meters written to the USB stick supplied with the system Your physician or dealer will inform you about the next steps Make sure that your USB stick is inserted...

Страница 12: ...the cables on the OkuSpex Start the stimulation It is recommended to keep the eyes closed during stimulation After stimulation The stimulation stops automatically after 30 minutes Carefully remove the...

Страница 13: ...in the hand again Note Always take the OkuSpex off first before using the hexagon screwdriver 5 Use 5 1 Adapting the OkuSpex to the Patient Your OkuSpex has to be adapted by a healthcare professional...

Страница 14: ...emple Please close the sachet of the OkuEl counter electrodes after taking them out by folding the side that was torn open to protect remaining electrodes from drying out Fig 5 2 Position of the count...

Страница 15: ...eal has to face outward in this case The electrode must be pushed completely onto the u shaped arm so that it finishes flush with the electrode holder In case of the stimulation of only one eye only o...

Страница 16: ...ting on the nose Please ensure that the outer edges of the black OkuEl electrode clip do not come into contact with the eyes Only the elec trode thread must touch the conjunctiva above the lower eyeli...

Страница 17: ...ly be inserted easily when oriented correctly Please ensure that the plug is inserted fully into the connector A correct application of the therapeutic stimulation can otherwise not be guaranteed Fig...

Страница 18: ...The stimulation strength increases slowly at the beginning until the therapeutic stimulation strength is reached This ramping up phase is indicated in the display with a ramp symbol If the device cann...

Страница 19: ...f the OkuStim device Disconnect the cables of the OkuEl counter electrodes by pulling off the pushbuttons Never pull the cables as they can tear When taking off the OkuSpex open the eyes wide so the O...

Страница 20: ...for wearers of contact lenses can help If the reddening persists after 1 2 days we recommend consulting a doctor In advanced stages of the disease the electrical stimulation can cause slight pain The...

Страница 21: ...s Ramping slow increase of stimulation strength Resistance left eye Ohm here OS 7750 Resistance right eye Ohm here OD 7760 Current date and time here 2020 01 01 10 12 30 During stimulation with the Ok...

Страница 22: ...ay Battery status Patient s name here John Miller Stimulation status stim stopped Left eye OS Right eye OD Current date and time here 2020 01 01 10 12 30 After ending a stimulation with the OkuStim th...

Страница 23: ...rt to long S S S S L L L Device switches off S S S Stimulation running SS SS SS Stimulation paused LS Stimulation was terminated or stimulation ends after automatic shutdown Explanation of the symbols...

Страница 24: ...an acoustic signal of long and short beeps Should the batteries be inserted incorrectly the switch on acoustic signal will not be heard In this case the polarity of the batteries must be corrected Whe...

Страница 25: ...lly packaged in the electrode package The shelf life of the OkuEl electrodes is indicated on the label on the front of the individual package Please store the OkuEl electrodes at 20 C 25 C ambient tem...

Страница 26: ...asonic cleaning is not permitted 11 2 Cleaning and Care of the OkuStim Switch off the OkuStim before cleaning The OkuStim and the OkuSpex cable can be cleaned using a soft lint free cloth The cloth sh...

Страница 27: ...ectricity If the error persists further please contact your optician There is no mini USB stick in the device or it has not been inserted properly Please switch off the device and check if the USB sti...

Страница 28: ...lectrode SS SS SS S Stimulation could not commence because the configuration file could not be found Please ensure the mini USB stick is correctly inserted into the OkuStim with the gold contacts faci...

Страница 29: ...g Life The OkuStim system has an expected operating life of 16 years The OkuEl electrodes and OkuEl counter electrodes have a shelf life of 18 months The shelf life is indicated on the packaging Opera...

Страница 30: ...be treated as household waste They have to be disposed of at a local waste collection site for the recycling of electrical waste Further information can be obtained from Okuvision GmbH or your OkuSti...

Страница 31: ...n equivalent successor model which may have design changes Regardless of the legal warranty claims Okuvision GmbH does not issue any other guaran tees for this product Liability for damages or consequ...

Страница 32: ...r of this equipment could result in increased elec tromagnetic emissions or decreased electromagnetic immunity of this equip ment and result in improper operation The OkuSpex cable has a length of 1 6...

Страница 33: ...scharge 8 kV contact discharge 2 4 8 und 15 kV air discharge Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Po...

Страница 34: ...Instructions for Use 03 Notes Rev 2021 07 01 OkuStim System TD60K06 34 36...

Страница 35: ...Instructions for Use 03 Notes Rev 2021 07 01 OkuStim System TD60K06 35 36...

Страница 36: ...Instructions for Use 03 Okuvision GmbH 2021 Rev 2021 07 01 OkuStim System TD60K06 36 36...

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