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PROFESSIONAL MEDICAL PRODUCTS
OCCHIALI NISTAGMO
NYSTAGMUS SPECTACLES
NYSTAGMUSBRILLE
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.
Jeder schwere Unfall im Zusammenhang mit dem von uns gelieferten medizinischen Gerät muss unbedingt dem Hersteller und
der zuständigen Behörde des Mitgliedsstaats, in dem das Gerät verwendet wird, gemeldet werden.
503 (31206)
DEHAG
Medizin-Technische Produktions
GmbH & Co.KG
Hinter dem Hamberge 24, 37124 Rosdorf
Made in Germany
Distribuito da / Distributed by / Vertrieben von:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M31206-M-Rev.1-09.21
-30°C
60°C
700 hPa
1060 hPa
30%
75%
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ENGLISH
Dear Customers,
Thank you for purchasing this nystagmus spectacle. Please read this instruction carefully before using your new nystagmus spectacle carefully to ensure proper handling and long service life.
With the nystagmus spectacle it concerns an investigation instrument which serves to observe spontaneous quick
ocular movements (nystagmus) with patients with disturbances of the balance sense.
Read the safety instructions carefully and still only use the nystagmus spectacle as described in this manual, so it does
not accidentally 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.
• Always place the nystagmus spectacle on the removable inlay in the outer carton.
• 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. Only use an original replacement lamp
as a replacement.
• Please remove the batteries before sending the nystagmus spectacle.
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.
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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!
• Any signs or wear and tear due to regular use are excluded from the warranty!
• Make absolutely sure that no liquid enters the battery handle or the nystagmus spectacle!
• Make sure to use dry batteries only and that the handle is clean and dry before inserting batteries!
• Screen the nystagmus spectacle and the accessoires from the sun. Keep dry! The products have to shelter from
humidity about 75%!
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 instructions, wrong or defective accessories.
Electricity
• To ensure the power supply of the nystagmus spectacle, use three batteries of size C LR14 / AM-2 (baby cells) á 1.5
volts
• When inserting the batteries make sure the poles are connected correctly.
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Insert the batteries
Use
Before any use the product has to be cleaned or disinfected and the good function and the integrity has to be
checked.
• It is to use only the accessories specied by the manufacturer.
• Unscrew the cover of the battery handle.
• Insert 3x 1.5 V C LR14 / AM-2 size batteries (batteries not inclusive) making sure the indicated battery polarity is
observed.
• Then, turn the battery cover back onto the battery handle.
• Remove batteries from of the battery compartment as soon as they are empty or if the device will not be used for a
longer period of time.
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 LED nystagmus spectacle package includes all of the following items. If any of these items are missing, please
contact the dealer for assistance.
1x nystagmus spectacle 1x user’s instruction
1x carton 1x inlay
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ENGLISH
Operation
General
With the purchase of the nystagmus spectacle you have the opportunity to do a short-term examination, in mobile use.
The nystagmus spectacle is held directly in front of the patient‘s eyes, thus enabling a quick uncomplicated search for
provocation nystagmus, e.g. by head shaking.
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.
• Hold the nystagmus spectacle rmly with one hand on the battery hold.
• Switch on the nystagmus spectacle by pressing the blue knob and turning the adjustment wheel clockwise.
• By turning the adjustment wheel clockwise, you can dim the brightness to the limit of the rotary switch (about. 3/4
turn).
If you turn the adjustment wheel without pushing the knob or turning the adjustment wheel further then the end
stop can destroy the switch.
• Switching off the device is done in reverse order.
• When you will not be using the nystagmus spectacle for a prolonged period, take the batteries out of the batterie
holder.
Processing instructions
Store your nystagmus spectacle in a closed place, on the inlay provided, where it is 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. If you send the nystagmus spectacle for repair, please remove
the batteries before sending.
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 disinfectants.
• 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.
Drying
Allow the device to dry for at least one hour before reuse.
Otherwise there is a risk that an explosive mixture of air and cleaning agent may ignite when the device is switched on.
Control and testing
Check the parts after cleaning for visible dirt. You may need to repeat the cleaning.
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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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Technical data
• Power supply: 3 x batteries baby cellls type LR14/AM-2; á 1,5V
• Dimensions: 185 x 130 x 100 mm
• Weight: approx. 270g (w/o batteries)
• 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 Follow instructions for use
Lot number Keep in a cool, dry place Date of manufacture
Manufacturer
WEEE disposal
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
Temperature limit Humidity limit
Atmospheric pressure limit
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