Okuvision OkuStim User manual

Instructions for Use03
Instructions for Use
EN
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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 [phone]
E-Mail: [email protected] www.okuvision.de
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 identication documents
agreement with the Medical
Device Directive 93/42/EWG,
notied body code: TUV Rhein-
land (= 0197)
Part number
Do not use if packaging is
damaged
Note waste disposal specica-
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 certied 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 modied.
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 inammation.
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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