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PROFESSIONAL MEDICAL PRODUCTS
OCCHIALI NISTAGMO
NYSTAGMUS SPECTACLES
LUNETTES POUR NYSTAGMUS
GAFAS NISTAGMO
ÓCULOS NISTAGMO
ΓΥΑΛΙΑ ΝΥΣΤΑΓΜΟΥ
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al fabbricante e
all’autorità competente dello Stato membro in cui si ha sede.
All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent authority of the member state where your registered ofce is located.
Il est nécessaire de signaler tout accident grave survenu et lié au dispositif médical que nous avons livré au fabricant et à l’autorité compétente de l’état membre où on a le siège social.
Es necesario informar al fabricante y a la autoridad competente del Estado miembro en el que se encuentra la sede sobre cualquier incidente grave que haya ocurrido en relación con el producto sanitario que le hemos suministrado.
É necessário noticar ao fabricante e às autoridades competentes do Estado-membro onde ele está sediado qualquer acidente
grave vericado em relação ao dispositivo médico fornecido por nós.
Σε περίπτωση που διαπιστώσετε οποιοδήποτε σοβαρό περιστατικό σε σχέση με την ιατρική συσκευή που σας παρέχουμε θα
πρέπει να το αναφέρετε στον κατασκευαστή και στην αρμόδια αρχή του κράτους μέλους στο οποίο βρίσκεστε.
501 (31204)
DEHAG
Medizin-Technische Produktions
GmbH & Co.KG
Hinter dem Hamberge 24, 37124 Rosdorf
Made in Germany
Distribuito da / Distributed by / Distribué par / Distribuido por /
Distribuído por / Διανεμήθηκαν από:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M31204-M-Rev.5-09.21
-30°C
60°C
700 hPa
1060 hPa
75%
30%
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ENGLISH
Dear Customers,
Thank you for purchasing this nystagmus spectacle. Please read this instruction carefully before using your new nystagmus spec- tacle carefully to ensure proper handling and long service life.
With the nystagmus spectacle it concerns an investigation instru- ment which serves to observe spontaneous quick
ocular move- ments (nystagmus) with patients with disturbances of the balance sense.
Read the safety instructions carefully and still only use the nystag- mus spectacle as described in this manual, so it
does not acciden- tally come in injury or damage. Keep this instruction for use to the later checking up. With passing
on of the nystagmus spectacle you also hand over this instruction for use.
Safety instructions
General
• Please read these instructions carefully and retain them for reference.
• Use this nystagmus spectacle solely in accordance with these instructions.
• The lenses are very delicate, handle the spectacle with great care.
• Avoid placing the nystagmus spectacle on surfaces that could scratch the lenses.
• This nystagmus spectacle may only be used by medical staff. This instruction do not replace a good medical education.
• Misuse or any modication is not under the responsibility of the manufacturer.
• Please check every instrument before every use.
• Have any repairs carried out solely by a qualied electrician.
• Repairs may only be carried out with original spare parts which are installed according to the intended use.
• Never try to repair the nystagmus spectacle yourself.
• Replace a defective lamp by carefully unscrewing the lamp from the socket.
Before removing the lamp, it is necessary to make sure that the instrument is off for some minutes to avoid the
risk of burning.
• Any change leads to the exclusion of liability.
• The CE-sign looses is validity in case of the use of any non original spare parts.
• If you transfer the appliance to a third party, also hand over this instruction manual.
Warnings
• Do not use damaged instruments!
• Protect the nystagmus spectacle and its parts against all kind of mechanical damage or force!
• Avoid hitting the lenses, which could break and cause damages!
• Do not throw and use with care!
• Misuse, damage, and wear are not covered by the warranty!
• Screen the nystagmus spectacle and the accessoires from the sun. Keep dry! The products have to shelter from
humidity about 75%!
• Any signs or wear and tear due to regular use are exclu- ded from the warranty!
• Make absolutely sure that no liquid enters the nystagmus spectacle or the accessoires!
Intended use
Device for short-term examinations or for mobile use in the eld of vertigo diagnostics.
Indication/Contraindication
Whether the use of Frenzel spectacle is indicated depends on the type of nystagmus examined. For example, Frenzel
spectacle are used to assess spontaneous nystagmus, but are not suitable for observing directional nystagmus.
Side effects and residual risks
Contamination due to non-compliance with the preparation instruction, wrong or defective accessories.
Electricity
In order to provide the nystagmus spectacle with power, you can use the battery case code 31214 or the plug- in power
supply code 31203 (not included in delivery). Other voltage sources are not permitted and will void the warranty and
guarantee.
To increase safety, the connect on of the nystagmus spectacle has been provided with a at plug which does not t into
a mains socket. Therefore, never try to force the at plug into a power outlet.
• Verify that the mains voltage is the same as that indicated on the type plate on the appliance before use.
• Only connect the power supply of the nystagmus spectacle to an earthed socket.
• Always remove the plug from the socket when the nystagmus spectacle is not in use.
• Always remove the plug from the wall socket by pulling on the plug, not the power cord.
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• Make sure that the appliance, the power cord and plug do not come in contact with water.
• Do not cut, pinch or separated the plug.
• Check the power cord regularly to make sure it is not damage.
• Do not use the nystagmus spectacle if the power cord is damaged. Have a damaged power cord re- place by a
qualied service technician.
Use
• Before any use the product has to be cleaned or disinfected and the good function and the integrity has to be
checked.
• Connect the nystagmus spectacle to a 4 volt power source before use.
Do not use other voltage sources, as higher voltages can burn out the lamps and thus increase the risk of accidents and injuries. In case of malfunction or damage caused by the use of other voltage sources, we cannot assume
any liability or warranty.
• Please disconnect the nystagmus spectacle from the power source if you do not use them for a longer period of time.
• Make sure that your hands are dry before touching the nystagmus spectacle, power cord or plug.
• Remove the plug from the power supply in the event of a malfunction during use, and before cleaning the nystagmus
spectacle, tting or removing an accessory, or storing the appliance after use.
• It is to use only the assessories specied by the manufacturer.
• Please note that you should only pull on the pin plug/ socket and not directly on the cable when connecting or dis-
connecting the pin plug! The plugs of the nystagmus spectacle and the sockets of the power supply should only be
pushed together/puled apart.
ENGLISH
Package Contents
• Please check the packaging and complain any damage immediately to the carrier.
• After opening the packaging, please check the contents of the packaging for damage that may have occurred due
to improper handling during transport.
• Your nystagmus spectacle package includes all of the fol- lowing items. If any of these items are missing, please
con- tact the dealer for assistance.
1x nystagmus spectacle 1x clip-head strap 1x user‘s instruction 1x carton
Optional accessories
To power the nystagmus spectacle we recommend the fol- lowing separately available accessories:
Battery case (31214) or Power supply (31203)
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ENGLISH
Operation
General
With the purchase of the nystagmus spectacle you have the opportunity to do an examination for which the nystagmus
spectacle remain for a longer time on the patient‘s head. The associated clip-head strap provides a secure xation of
the spectacle in front of the patient´s eyes and facilitates an easy search spontaneous and provoked nystagmus e.g.
through shaking the head, storing or examinations on swivel-chaires.
The nystagmus spectacle is equipped with strong refractive biconvex magnifying lenses with a power of +15 to +18
diopters. They prevent a sharp vision and the xation of objects. In this way, the patient‘s visual contact with objects
in the environment is interrupted, which would hinder the fast eye movements. At the same time the highly illuminated
eyes are easily observable under magnifying glasses.
Use
• Clean the nystagmus spectacle with a soft cloth moistened with water and a mild, alcohol-free detergent before each
use. Then dry the glasses thoroughly with a soft dry cloth.
• Please make sure that the nystagmus spectacle is in an undamaged, technically perfect condition.
• Hold to the patient the nystagmus spectacle in front of the eyes over the nasal bridge.
• Place the clip-head strap over the patient‘s ears and around the back of the head.
• Make sure that the nystagmus spectacle do not shift during the examination. If necessary, tighten the clip- head
strap more tightly.
• Insert the at plug of the nystagmus spectacle either into the battery container type 31214 or into the power supply
code 31206 (both not included).
• Plug the power supply code 31206 into a 220V power supply. The battery case is powered by three 1.5 volt C LR14/
AM-2 size batteries (baby cells).
Processing instructions
Store your nystagmus spectacle in a closed place where they are protected from dust and dirt to ensure their hygienic
conditions.
All surfaces of the appliance are not sensitive to conventional, mild, alcohol-free cleaners. A soft cloth or absorbent
paper should be used to apply cleaning liquids, in order to avoid scratching the surface and to dose and spread out the
liquid better. Incorrect or incomplete cleaning may jeopardize the patient or medical staff!
Restriction regarding reprocessing
The end of the product service life is usually determined by wear and damage caused by use.
Place of use
Remove surface soiling with a soft disposable cloth.
Maintenance
Please sort damaged parts and have them repaired.
Cleaning / Disinfection: automatically
• An automatic cleaning and disinfection is not approved for the device.
• Do not disinfect by spray or soak!
Cleaning: manual
Clean the nystagmus spectacle after each use.
• Clean the nystagmus spectacle with a damp cloth and, perhaps, a little bit mild, alcohol-free cleaners or disinfect-
ants.
• Never use corrosive or scouring cleaning agents or sharp objects to clean the appliance.
• Dry the nystagmus spectacle with a soft, dry cloth thoroughly.
• Do not immerse the nystagmus spectacle set in water, or in other liquids.
Control and testing
Check the parts after cleaning for visible dirt. You may need to repeat the cleaning.
Packaging
The nystagmus spectacle must not be packaged in sterile packaging. Other packages are also possible.
Sterilization
Do not sterilize the nystagmus spectacle, thus electronic components can be damaged by high temperatures.
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ENGLISH
Technical data
• Power supply: max. 4.5 Volt, 500mA
• Dimensions: 190 x 90 x 70 mm
• Weight: approx. 180g (only spectacle)
• Protection class: IP X0
Classication according to:
• MPG: Class I, according to Annex IV of Directive 2017/745 (EU)
• CE marking: according to Directive 2017/745 (EU)
• RKI: uncritical
Storage and transport conditions
• Storage temperature: -30 to 60°C
• Working temperature: 0 to 25°C
• Humidity: 30 to 75%
• Barometric pressure: 700 to 1060 hPa
Product code Keep away from sunlight
Lot number Keep in a cool, dry place Date of manufacture
Manufacturer
WEEE disposal Temperature limit Humidity limit
Caution: read instructions (warnings) carefully Medical Device
Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of
this equipment by bringing it to a specic recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Medical Device compliant
with Regulation (EU) 2017/745
Follow instructions for use
Atmospheric pressure limit
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