Okuvision OkuStim Instructions For Use Manual Download Page 1 | Manualshive

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Instructions for Use

03

Instructions for Use

EN

Rev. 2021-07-01

OkuStim

System

TD60K06 -

OkuStim

® System

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Summary of Contents for OkuStim

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

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

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