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PROFESSIONAL MEDICAL PRODUCTS
NUOVA LAMPADA FRONTALE WIDA A FIBRE OTTICHE
NEW WIDA: F.O. HEAD LIGHT
NOUVELLE LAMPE FRONTALE À F.O. WIDA
NUEVA LÁMPARA FRONTAL DE FIBRA ÓPTICA WIDA
• 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.
30853 - 30854
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M30853-M-Rev.0-04.22
Made in Pakistan
ENGLISH
ATTENTION:
Thank you for purchasing our product. The F.O Headlights meet the most stringent requirements regarding
the selection of manufacturing material, performance, safety and nal control. These operating instructions
manual is related to Fiber Optic Headlights (GIMA codes 30853 and 30854). These instructions must be
followed to ensure the performance and durability of the both devices. The operator/user must read and
understand this manual thoroughly to keep the Product performance durable and reliable for dened
period.
After opening the package, it is necessary to check all the components against standard conguration.
Check that these are all present and in perfect condition.
INTENDED USE:
The F.O headlights are the medical devices used for illumination during examination. These medical
devices are used by surgeons / health care professionals for Surgery, ENT examination, Laparoscopy,
Neuro-endoscopy and other examinations.
PATIENT POPULATION:
The F.O headlights are not designed to be used directly on patients. However, these devices are used by
doctors, surgeons and/or health care professionals for examination of complete patient population.
FEATURES:
The featured of both devices are given below;
Fiber Optic Headlights
• The Fiber Optic headlight is supplied with ergonomic head band, which is padded and fully adjustable
in circumstances and height
• Superior comfort, durability and adjustability
• Head band cleaning made easier by removeable and washable padding
• Double lens precision optical with adjustable holder to focus the light point
• Illumination axis adjustable over wide range
• 3.5mm ber optic bundle cable length 2.3 meter
• Connector for use with other manufacturer’s projectors are available Supplied standard with Storz
connector
• GIMA code 30853 has double lens precision optical with adjustable holder to focus the light point
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ENGLISH
OPERATING INSTRUCTIONS
Before using the product, it is necessary to adjust the helmet to the head size. To do this, use opposite
adjusting screw located at the side, allowing to tight or loose the headbands.
i. Adjust the head band according to heads size and wear the device on head for operation
ii. Install the device according to the installation procedure and adjust the device for intended
examination
iii.
Place the patient at right position and switch ON the device for examination
AVVERTENZE
- The F.O Headlight is not compatible to use in MRI environment.
- Do not use the product in direct contact with skin. Use suitable protection.
- The F.O headlights can only be used by trained professional and qualied medical personnel in a healthcare facility.
- The Fiber light cable is delicate. Handle it with care. Do not curl it or bend it more than 60°
to avoid breakage in glass bers.
- Always switch off the device after the use.
- Does not use the devices at distance closer than 25 cm for longer periods, it may result in
Erythema.
- Do not look directly into the light source of headlight when illuminated. It can compromise
the eyesight.
- Do not remove the ber optic cable from the light source when light source is ON. The light
guide distal end may transfer extreme heat. Proximal end of ber optic cable may also be hot
after use.
- Disassemble the devices only when these are turned OFF and heat is dissipated.
- Do not use the equipment in case it is damaged. Avoid precarious repairs. Repairs shall be
carried out with original spare parts only, which shall be installed according to the intended
use. For any other repair/replacement apply to your retailer.
INSTALLATION
These medical devices have a simple set-up and installation procedure. The installation of medical
devices is illustrated below;
Fiber Optic Headlights
Head adjustable knob
GIMA 30831
The F.O cable can be adjusted, if required, by pulling the silicon rubber clip. The F.O cable is
composed of glass ber so, do not curl or bend the cable more than 60 degrees to avoid any ber
breakage.
Note: Always turn OFF the device and keep the it for few minutes for cooling before disassembly and/or
replacement of any component.
ENGLISH
CLEANING OF F.O HEADLIGHT
The F.O Headlights don’t require general cleaning. These devices are manufactured to last longer and
resistant to most of chemicals except methyl ethyl ketones. However, these can be cleaned by using
following steps;
• Cold clean the helmet with some disinfectant and a sponge
• Always keep the ber light guide light source end clean by using a damp cloth for optimal light output.
Allow to dry before use.
- Always turn OFF the device before cleaning. Don’t immerse the F.O headlight into sterilizer or
disinfectant liquids. It could cause damage to device.
- Avoid scratching or striking ends of bers cable. Reduction in light transmission may occur.
OPERATING ENVIRONMENT:
Temperature Limitation
55°C
Humidity Limitation
75%
%
Atmospheric Pressure Limitation
1060 hPa
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10°C
30%
700 hPa
STORAGE ENVIRONMENT:
Temperature Limitation
60°C
-20°C
Humidity Limitation
95%
%
15%
Atmospheric Pressure Limitation
1060 hPa
500 hPa
MAINTENANCE:
These devices are maintenance free.
SERVICE:
The device has no components serviceable by the end-user.
CAUTIONS/GENERAL WARNINGS:
• Read the label before unpacking. Do not use the device in case of damaged packing.
• Do not use the equipment in case it is damaged. Apply to your Retailer / Distributor.
• Always remember that packing elements (paper, cellophane, stitches, adhesive tape, etc.) can cut
and/or hurt if they are not carefully handled. They shall be removed with adequate means and shall
not be left at the mercy of irresponsible persons.
• If the light is intermittent or in case it does not turn on, check the batteries and the electrical contacts.
•
This product is not allowed to enter or be used in areas with strong magnetic elds e.g. MRI scanners.
• Any unauthorized modication/service is strictly prohibited at user end so, always contact the
authorized person or send the unit back to the authorized agent.
• Autoclaving and Flash sterilizing of devices will result in severe electrical and mechanical damages
so, these are strictly prohibited.
• Ultrasonic cleaning is not recommended
• Store the device in clean and recommended environment
• Conservare il dispositivo in un ambiente pulito e secondo quanto raccomandato
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ENGLISH
SHELF-LIFE:
The product has been conceived to last longer. However, the minimum shelf-life of these devices is 5
years.
SYMBOL INFORMATION:
Keep away from
sunlight
Product code Consult instructions for use Manufacturer
Caution: read
instructions
(warnings) carefully
WEEE disposal Data di fabbricazione Temperature Limitation
Medical Device compliant with
Regulation (EU) 2017/745
Lot number Medical Device
Keep in a cool, dry place
%
Humidity Limitation
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.
Atmospheric Pressure
Limitation
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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