Summary of Contents for Okuvision OkuStim
- Page 1 Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use OkuStim® System Instructions for Use...
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Page 2: Important Notice
Users and Places of Use The OkuStim system is suitable to be used for electrical stimulation by trained laypersons and specialists in a professional healthcare or home environment. The programming of the stimu- lation parameters must be performed by healthcare professionals. -
Page 3: Explanation Of Symbols
TD60K06 - Instructions for Use Explanation of Symbols On the packaging you will find the following symbols and description of the components of the OkuStim system: OkuStim device / OkuSpex frame / OkuEl electrode / OkuEl counter electrode Medical device Packaging unit Ref. -
Page 4: Important Safety Notes
µ This product may be used only according to the instructions and prior setting-up by a health- care professional. Patients must use only the device especially intended for them. µ The OkuStim system is subject to mandatory prescription and may be given to patients only as prescribed by a doctor. -
Page 5: Indications / Contraindications
TD60K06 - Instructions for Use Indications / Contraindications Indications The TES-Therapy with the OkuStim system is indicated for the treatment of µ retinitis pigmentosa (also syndromic, e.g. Usher syndrome) µ similar retinal diseases like cone-rod dystrophy or choroideremia Contraindications The TES-Therapy must not be applied: µ... -
Page 6: Table Of Contents
Opening the OkuEl Electrode Package ............. 14 Inserting the OkuEl Electrode Into the OkuSpex Frame ......15 Putting on the OkuSpex ................16 Connecting the OkuSpex with the OkuStim ..........17 Stimulation According to Doctor’s Prescription ......... 18 Storing the OkuSpex ................. 19 Removing the OkuEl Counter Electrodes from the Skin ...... - Page 7 Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use Side Effects ....................20 Explanation of the Display Information of the OkuStim ......21 Acoustic Signals ..................23 Inserting and Changing Batteries .............. 24 Storage ......................25 10.1 The Electrode Package ................25 Cleaning Instructions ..................
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Page 8: What Is Okustim
Instructions for Use What is OkuStim? OkuStim is a system for transcorneal electrical stimulation (TES) for the treatment of retinal dystrophies. The externally applied therapy is designed for independent use at home. Electrical stimulation therapy with the OkuStim System can help to slow down the narrowing of the visual field and thus retain usable vision for longer in patients suffering from retinitis pigmentosa and other generalized inherited retinal disease. - Page 9 For hygienic reasons, the OkuEl electrodes and OkuEl counter-electrodes may only be used once. Therapy Upon turning on the OkuStim the eyes will be electrically 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.
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Page 10: Scope Of Delivery
Instructions for Use Scope of Delivery You will receive your OkuStim system in a sturdy transport box which also serves as storage for the individual system components. After use, place the OkuSpex open and not folded back into its compartment. Do not wrap the cable around the OkuSpex as this may cause misali- gnment of the electrode holders. -
Page 11: Before First Use
Make sure that your USB stick is inserted correctly in the OkuStim. The USB stick has a white and a black side. The white side must face upwards when inserted into the socket on the bot- tom of the OkuStim. -
Page 12: Brief Guide To Performing A Therapy Session
Put it into the designated compartment in the box. • Switch off the OkuStim device (in case it has not already switched off automatically). • Remove the counter electrodes from your forehead and dispose of them together with the OkuEl eletrodes with the general waste. -
Page 13: Use
Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use 5.1 Adapting the OkuSpex to the Patient Your OkuSpex has to be adapted by a healthcare professional (at the eye clinic or optician) so that the electrodes come to rest on the conjunctiva, below the pupil (see fig. 5-1 and fig. 5-5). -
Page 14: Attaching The Okuel Counter Electrodes To The Body
Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use 5.2 Attaching the OkuEl Counter Electrodes to the Body The OkuEl counter electrodes are attached in the area of the temple. If only one eye is to be stimulated, the OkuEl counter electrode is only required on the respective side. -
Page 15: Inserting The Okuel Electrode Into The Okuspex Frame
Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use 5.4 Inserting the OkuEl Electrode Into the OkuSpex Frame To insert the OkuEl electrode into the electrode holder, the OkuEl electrode is pushed from the face-side of the OkuSpex onto the u-shaped arm of the electrode holder. The electrode side with the blue seal has to face outward in this case. -
Page 16: Putting On The Okuspex
You can close the eyes during stimulation. When receiving your OkuStim system, the correct way of putting on the OkuSpex should have been explained to you by a healthcare professional. -
Page 17: Connecting The Okuspex With The Okustim
5.6 Connecting the OkuSpex with the OkuStim Connect the plug of the OkuSpex cable with the connector on the top of the OkuStim. Ensure that the flat surface of the plug is facing up. The plug can only be inserted easily when oriented correctly. -
Page 18: Stimulation According To Doctor's Prescription
A sequence of long and short beeps confirms that the device is switched on. If pos- sible, check if your name is shown in the OkuStim display when switching on. Depending on the treament pathway for your region, the stimulation parameters will appear in the display instead of your name. -
Page 19: Storing The Okuspex
The OkuEl electrodes and OkuEl counter electrodes are single use items and must not be used multiple times for hygienic and technical reasons. Only store the OkuStim and OkuSpex in the designated box. It is best to store OkuEl electrodes in their box - the OkuEl Electrode Package - until use. -
Page 20: Side Effects
Instructions for Use Side Effects Using the OkuStim on the eye can occasionally result in a slight mechanical irritation of the cornea. This can cause a reddening of the eye and a feeling of dryness. In this case, over-the- counter available eye drops, also known as artificial tears for wearers of contact lenses, can help. -
Page 21: Explanation Of The Display Information Of The Okustim
Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use Explanation of the Display Information of the OkuStim When switching on the OkuStim , the following information is shown in the display: Serial number of OkuStim: S/N:0001 v2.XX – here S/N: 0001 Firmware Version of the OkuStim: –... - Page 22 Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use While pausing the stimulation with the OkuStim, the following information is shown in the display: Battery status: – John Miller Patient‘s name: 00:27:59 Paused – here John Miller OS - OD -...
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Page 23: Acoustic Signals
Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use Acoustic Signals Acoustic signal Meaning 13x beep from long to short Device switches on L-L-L-L-L-S-S-S… 13x beep from short to long Device switches off S-S-S-S-L-L-L-… S---S---S(...) Stimulation running SS---SS---SS (...) Stimulation paused... -
Page 24: Inserting And Changing Batteries
Please remove the mini-USB stick previous to changing or inserting the batteries for the first time. If you are planning not to use the OkuStim for more than 4 weeks, please take out the batteries. Four type AA batteries (Mignon) are inserted into the compartment on the back of the OkuStim. -
Page 25: Storage
Handle the entire system carefully in order to avoid any damage to the electronics or causing other malfunctions. Do not expose the OkuStim, OkuEl or the OkuEl counter electrodes to excessive moisture, heat, cold or dirt accumulation. Switch off the device before cleaning (see 11). -
Page 26: Cleaning Instructions
Switch off the OkuStim before cleaning. The OkuStim and the OkuSpex cable can be cleaned using a soft, lint-free cloth. The cloth should be damp at most, never wet. It is important to ensure that no moisture gets inside the device, however if moisture enters the OkuStim must undergo a safety and function check before the next use. -
Page 27: Troubleshooting
12:00:00 µ check if the cable of the counter electrode is connected µ check if the plug of the OkuSpex is connected with the OkuStim µ resume stimulation by pressing “START” (right) Short circuit in at least one electrode. In such a case, please contact your optician directly. -
Page 28: Acoustic Signals
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 facing down, or consult your doctor for re-writing the programming on the mini-USB stick. -
Page 29: Technical Data
Protection Class: internally powered (battery powered) Applied Part: Type BF Operating 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. -
Page 30: Disposal Of Used Devices And Batteries
OkuEl electrodes and OkuEl counter electrodes that have been in use can be disposed of as normal household waste. The OkuStim and OkuSpex are not to be treated as household waste. They have to be disposed of at a local waste collection site for the recycling of electrical waste. -
Page 31: Warranty
OkuStim systems, which have been caused through the utilization of products other than those manufactured by Okuvision GmbH. µ Okuvision GmbH reserves the right to replace devices in the event of a warranty claim with an equivalent successor model, which may have design changes. -
Page 32: Information Regarding Electromagnetic Compatibility
OkuStim system could be compromised. See table in this chapter. Warning: Interference of the OkuStim is possible in the frequency range of 80 MHz to 86 MHz. In this case, the error message „Error Defect!“, see chapter 13, will be displayed. - Page 33 Guidance and manufacturer’s declaration for electromagnetic compatibility The OkuStim system is intended for the use in the electromagnetic environment specified below. The customer or the user of the OkuStim system should assure that it is used in such an electromagnetic environment. Immunity test...
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- Page 36 Rev. 2021-07-01 OkuStim System TD60K06 - Instructions for Use © Okuvision GmbH 2021 36 36...