Okuvision OkuStim User manual
Instructions for Use03
Instructions for Use
EN
Rev. 2021-07-01 OkuStim SystemTD60K06 -
OkuStim® System
Instructions for Use03
Important Notice
Copyright © 2021 Okuvision GmbH. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval
system or translated into any language or any computer language, in any form or by any third
party, without the prior written permission of Okuvision GmbH.
Any software described in this publication is furnished under a license agreement.
All other trademarks are the property of their respective owners. Other company and brand
products and service names are trademarks or registered trademarks of their respective
holders.
Manufacturer
Okuvision GmbH
Aspenhaustraße 25
72770 Reutlingen Germany
Fon +49(0)7121 159 35-0
Intended Use
The 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 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.
Purpose of this Manual
This user manual provides the necessary instructions for safely operating the OkuStim in
accordance with its function and intended use. These instructions include:
µAn explanation of the function of controls and indicators
µInstructions on handling the OkuStim system
µInstruction of the application of electrical stimulation sessions
µInstructions on maintenance and troubleshooting
Version Note
This manual is applicable for OkuStim rmware version 2.03 and above.
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Explanation of Symbols
On the packaging you will nd the following symbols and description of the components of the OkuStim
system: OkuStim device / OkuSpex frame / OkuEl electrode / OkuEl counter electrode
Medical device
Ref. to instructions for use
Ref. to instructions for use
General warning symbol
Batch designation
Serial number
Use by date
Date of manufacture
Manufacturer
Packaging unit
Not for reuse
Sample for temperature range
The CE identication documents
agreement with the Medical
Device Directive 93/42/EWG,
notied body code: TUV Rhein-
land (= 0197)
Part number
Do not use if packaging is
damaged
Note waste disposal specica-
tions
IP22
Casing protection class: protec-
ted against foreign objects with
a diameter of 12.5 mm or above
and against dripping water with
15° angle.
Applied Part: Type BF
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Important Safety Notes
µThis 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.
µThe OkuStim system is subject to mandatory prescription and may be given to patients only
as prescribed by a doctor.
µBefore using the device please familiarize yourself with the user manual and note the infor-
mation about electromagnetic compatibility (page 33).
µOnly use the accessories supplied with the product or those listed in the accessories list
Chapter 17. Do not connect any cables or parts to the device that are not mentioned in the
list.
µThe OkuEl electrode consists of a silver thread. Users with silver allergies may only use the
OkuEl electrode after medical consultation.
µThe use of local anaesthetics on the eye and the application of the therapy when wearing
contact lenses are not permitted.
µWhen using the OkuStim System with an endotamponade of the eye with silicone oil, the
functionality of the stimulation cannot be ensured.
µ Only healthcare professionals are allowed to connect a certied 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).
µ The device must not be opened or modied.
µDuring an electrical stimulation session with OkuStim it is not allowed to undergo any
additional treatment using electrical stimulation.
µUse the device only while seated or lying down. Do not move around and try to stay clear of
objects on which the OkuSpex electrode could get caught. Beware of strangulation with the
cables.
µPlease note that the density of electric current can exceed 2 mA/cm2 at the OkuEl electrode.
µPlease note that the device can heat up to 42°C during use.
µAttach the plug of the OkuSpex cable fully to the connector of the OkuStim.
µKeep the device and accessories outside of reach of children. Small parts like the mini-USB-
Stick could be swallowed.
µCheck the seams of the individual OkuEl Electrode packaging. Use only OkuEl electrodes
with intact packaging.
µThe OkuEl electrodes are single-use products and must not be used more than once. In case
of reprocessing and/or usage of an OkuEl for more than one therapy session the functiona-
lity of the OkuEl cannot be ensured. Multiple use may result in ineffectiveness of the therapy
and/or lead to an infection of the eyes.
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Indications / Contraindications
Indications
The TES-Therapy with the OkuStim system is indicated for the treatment of
µretinitis pigmentosa (also syndromic, e.g. Usher syndrome)
µsimilar retinal diseases like cone-rod dystrophy or choroideremia1
Contraindications
The TES-Therapy must not be applied:
µin patients with blood vessels with growth processes that could be accelerated by electrical
stimulation, like:
– ocular neovascularization of any origin,
– macular edema,
– artery or vein occlusion,
– diabetic retinopathy,
– age-related macular degeneration.
µin patients who have a severe acute or chronic disease according to their medical evalua-
tion (medical, psychiatric, other abnormal clinical ndings) that could be worsened by the
therapy.
µin patients with active implants2,
µin case of current pregnancy,
µwhilst breastfeeding,
µ in case of acute eye inammation.
Conditions for the application of transcorneal electrical stimulation
therapy are:
µPatients’ ability to give consent,
µ Visual acuity of at least light perception,
µPatients must be able to sit still for 30 minutes.
1 According to the work group “Clinical Issues” of the German Patient Organization PRO RETINA there are no
objections to treating these diseases with TES. Source: https://www.pro-retina.de/forschungsfoerderung/
wissenschaftliche-beratungsgremien/empfehlungen/bewertung-zur-elektrostimulation-am-auge
2Patients with cochlear implants can apply the TES-therapy, provided the implant is deactivated and external
components are removed for the duration of the stimulation.
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Content
Important Notice ........................................................................................................2
Manufacturer...............................................................................................................2
Intended Use................................................................................................................2
Users and Places of Use .............................................................................................2
Purpose of this Manual ...............................................................................................2
Version Note.................................................................................................................2
Explanation of Symbols...............................................................................................3
Important Safety Notes .............................................................................................4
Indications / Contraindications ..................................................................................5
1 What is OkuStim? ...........................................................................................8
2 Scope of Delivery ........................................................................................ 10
3 Before First Use ........................................................................................... 11
4 Brief Guide 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 Inserting the OkuEl Electrode Into the OkuSpex Frame ........................... 15
5.5 Putting on the OkuSpex............................................................................... 16
5.6 Connecting the OkuSpex with the OkuStim .............................................. 17
5.7 Stimulation According to Doctor’s Prescription......................................... 18
5.8 Storing the OkuSpex ................................................................................. 19
5.9 Removing the OkuEl Counter Electrodes from the Skin ........................... 19
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6 Side Effects................................................................................................... 20
7 Explanation of the Display Information of the OkuStim .......................... 21
8 Acoustic Signals .......................................................................................... 23
9 Inserting and Changing Batteries .............................................................. 24
10 Storage ......................................................................................................... 25
10.1 The Electrode Package ............................................................................... 25
11 Cleaning Instructions .................................................................................. 26
11.1 Cleaning, 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 Display Messages ........................................................................................ 27
13.2 Acoustic Signals ........................................................................................... 28
14 Technical data.............................................................................................. 29
15 Disposal of Used Devices and Batteries .................................................... 30
16 Warranty ...................................................................................................... 30
17 Accessories .................................................................................................. 31
18 Information Regarding Electromagnetic Compatibility .......................... 32
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1 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 eld and thus retain usable vision for longer in patients suffering from retinitis
pigmentosa and other generalized inherited retinal disease.
Electrical stimulation with weak currents can activate signalling pathways and the release of
substances in the diseased retina 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, retinal stimulation is achieved by transcorneal application of a weak current (<
1mA) to the surface of the eye, which spreads in towards the retina. The current is applied by a
thin electrode thread.
System Components
Socket for the cable of the OkuSpex
Display
START Button
Port for USB memory card
ON / OFF / STOP Button
PAUSE Button
USB Port for the doctor‘s PC
Fig. 1-2: OkuEl electrode
Electrode thread
Seal
Bracket
Please note: the depictions of the components in this booklet may differ slightly from the actual products.
Fig 1-1: OkuStim handheld device
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The OkuEl electrode is comprised of an arched clip with two ne threads, which are placed
below the pupil on the surface of the eye.
The OkuSpex frame serves as a holder for the OkuEl electrodes. It is connected to the Oku-
Stim with a cable. The OkuSpex can easily be adjusted to t the individual facial shape.
Similarly, the OkuEl electrodes can be inserted easily into the electrode holder of the OkuSpex
frame even by visually impaired persons.
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.
The individual treatment parameters for the patient will be determined and programmed on
the USB-stick of the OkuStim device by a healthcare professional.
The data generated during stimulation, such as electrical resistance values, are stored on the
USB-stick. This way the healthcare professional can monitor the course of the therapy.
The OkuStim device features a display and acoustic output for all essential operating states,
so that patients at advanced stages of visual impairment can use the device without problems.
Fig 1-3: OkuSpex frame
Counter electrode connector
Support bars
Nosebridge
Electrode holder
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2 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.
Package Contents:
• OkuStim® handheld 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® Electrode)
– 12 OkuEl® counter-electrodes (on the product label: OkuEl® Counter-Electrode)
• Hexagon socket screw key for adjustment of OkuSpex and replacing batteries in OkuStim
• Mini-USB stick (on the product label: OkuStim® USB-Stick)
• Transport box
• 4 Batteries AA
• Instructions for use
Abb. 2-1: Abb. 2-1: Transport- and storage box for the OkuStim system.
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3 Before First Use
Note:
• The individual treatment parameters have to be determined and programmed by a
healthcare professional.
• Patients with dry eyes (e.g. conjunctivitis sicca) are recommended to apply tear eye-drops
during TES-therapy.
• Patients with limited physical mobility (e.g. advanced rheumatism, Parkinson) may require
help when applying the TES-Therapy with the OkuStim.
You will have to have your OkuSpex individually adapted. For subsequent adjustments of the
electrode holders at home, the assistance of a second person might be helpful. If you have
any difculties, please contact the doctor or optician/dealer from whom you purchased the
OkuStim system.
Once you have received your OkuStim system and the OkuSpex has been tted, you may need
to make an appointment with your doctor for an 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 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.
Insert the batteries with correct polarities into the battery compartment at the rear of the
OkuStim.
Insert the USB stick into your OkuStim device and stimulate according to the instructions of
your healthcare professional. It is recommended that you leave the USB memory card in the
OkuStim unless it is absolutely necessary to remove it. Always ensure that the OkuStim is
switched off when inserting or removing it.
Arrange regular follow-up visits with your doctor to control settings and the application of the
therapy.
Fig. 3-1: The white side of the USB-stick must face upwards when inserted into the OkuStim.
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4 Brief Guide to Performing a Therapy Session
Please follow exactly the steps to prepare and conduct a stimulation session. You may other-
wise experience a spontaneous and strong phosphene perception.
Preparation before stimulation:
• Clean the skin before attaching the OkuEl counter electrode(s).
• Attach the OkuEl counter electrode(s) to the cleaned skin area(s).
• Insert the OkuEl electrode(s) into the electrode holder of the OkuSpex.
• Assume a comfortable and stable seated or reclined position.
• Put on the OkuSpex. You may want to pass the cable of the OkuSpex from behind around
your head.
• Switch on the OkuStim.
• Plug the OkuSpex cable into the OkuStim.
• Connect the OkuEl counter electrodes to 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 pushbutton connectors from the OkuEl counter electrodes. Never
pull the cables to remove the connectors as the cables may tear.
• Disconnect the OkuSpex cable from the OkuStim.
• Take off the OkuSpex and remove the electrodes from it.
• Put the OkuSpex back into the box. Do not fold the OkuSpex.
• Roll-up the cable loosely and do not wrap it around the OkuSpex as this may cause the
electrode holders to misalign. 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.
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Position the horizontal support rod so that the ends of the electrode holder come to rest near
the nasal and temporal canthus (corner of the eye); that is, just before the skin directly to the
right and left of the eye. Carefully move the horizontal support rod towards the eye. The Oku-
Spex are correctly adapted to the patient when the OkuEl thread rests below the pupil and
above the lower eyelid, against the cornea, free of pressure, with at least 1cm contact.
After tting, carefully tighten the hexagon socket screws on the joints of the OkuSpex frame
again. To tighten the screws, hold the OkuSpex frame in the hand again.
Note:
Always take the OkuSpex off rst 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 (at the eye clinic or optician) so
that the electrodes come to rest on the conjunctiva, below the pupil (see g. 5-1 and g. 5-5).
To do this, the hexagon socket screws at the joints of the OkuSpex are slightly opened to allow
the vertical and horizontal support rods to be moved smoothly. The OkuSpex is then careful-
ly tted with the eyes closed and the vertical support rods adjusted to the correct height. If
necessary, the height of the nose bridge of the OkuSpex can be adjusted.
Fig. 5-1: Adjustment of the OkuSpex electrode holder; Position of the electrode thread on the conjunctiva.
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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.
Before attaching the OkuEl counter electrodes thoroughly clean and dry the area of the skin
where the electrodes are to be attached. The use of alcohol pads is recommended for cleaning
since water and soap may be insufcient.
Pull the OkuEl counter electrode off the carrier lm and attach with slight pressure to the
cleaned area of the temple.
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 counter electrode; Fig. 5-3: Contact surface of the OkuEl
5.3 Opening the OkuEl Electrode Package
Before opening the individual OkuEl electrode packaging check if it is undamaged. Use only
OkuEl electrodes with intact packaging.
To unpack an OkuEl electrode, carefully peel away the lm from the paper until the entire
electrode can be freely removed from above.
For hygienic reasons, the OkuEl electrode may only touched on the black plastic clip. The elec-
trode thread (arrow), which makes contact with the eye, must not be touched with the ngers
(see g. 5-2).
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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. The electrode must be pushed completely
onto the u-shaped arm, so that it nishes ush with the electrode holder.
In case of the stimulation of only one eye, only one OkuEl electrode and one OkuEl counter
electrode are required. If both eyes are stimulated, two OkuEl electrodes and two OkuEl coun-
ter electrodes are required (see g.1-2 & 1-3, page 9).
Fig. 5-4: Inserting the OkuEl electrode into the OkuSpex
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5.5 Putting on the OkuSpex
The OkuSpex must be put on as it has been explained to you by a healthcare professional at
your induction appointment.
To put the OkuSpex on, place your head in the neck and open your eyes wide. The OkuSpex
will t correctly when the nose bridge is fully resting 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 eyelid. 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.
Fig. 5-5: OkuEl electrode on the eye touches only the conjunctiva under the pupil
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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 at surface of the plug is facing up. The plug can only 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. 5-6: Plug of the OkuSpex attached to the OkuStim
You can now turn on the OkuStim.
Lastly, the OkuEl counter electrode at the temple is connected with the pushbutton of the
OkuSpex.
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5.7 Stimulation According to Doctor’s Prescription
Switch on the OkuStim device by pressing the “ON/OFF/STOP” button (left) for at least one
second. A sequence of long and short beeps conrms 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. This will be changed at the rst follow-up visit in the eye clinic.
Connect the counter electrodes if you haven‘t done so, yet. Begin your therapy session by
pressing the “START” button (right).
During the stimulation, a regular sound – 1 beep per second – indicates the correct function
of the device. The remaining therapy time is shown in the display. 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 cannot carry out the stimulation properly, this is signaled by acoustic signal. You
can nd an overview of the acoustic signals and their meanings on page 23.
In such a case, interrupt the stimulation by pressing the „PAUSE“ button (middle) and:
µ check if the OkuSpex is tted correctly and the OkuEl electrodes are well positioned with
good contact to the eyes,
µlubricate your eyes with eye drops,
µcheck if the cable of the counter electrode is connected,
µcheck if the plug of the OkuSpex is connected with the OkuStim,
µresume stimulation by pressing “START” (right).
If the acoustic signal persists and OkuStim does not stimulate correctly, please contact your
optician/dealer.
Fig. 5-7: The three buttons on the OkuStim device from left to right: ON/OFF/STOP, PAUSE, START
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The termination of the stimulation session is signaled by a long beep, followed by a short beep.
The stimulation can be interrupted by pressing the „PAUSE“ button (middle). Pause-mode is
indicated by 2 short and recurring beeps. In order to continue your stimulation session, press
the „START“ button (right). The stimulation time counter will stop while paused and continue
when stimulation is resumed.
Three minutes after completion of the therapy, the OkuStim device switches off automatically.
You can terminate the stimulation at any time by pressing “ON/OFF/STOP” (left).
5.8 Storing the OkuSpex
Remove the plug of the OkuSpex from the connector of 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 OkuEl
electrodes can be removed easily from the eyes. After that, the OkuEl electrodes can be remo-
ved from the OkuSpex and disposed of with the general waste.
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.
5.9 Removing the OkuEl Counter Electrodes from the Skin
Pull off the OkuEl Counter electrodes carefully, starting on one side, and dispose of them with
the general waste.
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6 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 articial tears 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 following side effects are also known to occur with the OkuStim System (likelihood of
occurrence less than 1%):
µmacular cysts
µchanges of the lens
µvisual impairment
µcataract
µinfections
µpain outside the eye
Please inform your doctor if necessary.
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Table of contents
