Gima 30853 F.o. Head Light Instructions (+ PDF)

Contents hide

1 30853 F.O. Head Light

2 Product Information

3 Product Usage Instructions

3.1 Documents / Resources

3.1.1 References

30853 F.O. Head Light

Product Information

The F.O headlights are professional medical devices used for
illumination during examinations. They are designed for use by
surgeons, doctors, and healthcare professionals in various medical
procedures such as surgery, ENT examination, laparoscopy,
neuro-endoscopy, and other examinations. These devices are not
intended to be used directly on patients but rather for the
examination of the complete patient population.

The F.O headlights are made by Gima S.p.A., an Italian company
located in Gessate, Italy. The product is manufactured in Pakistan
and complies with Regulation (EU) 2017/745 for medical devices.

The main features of the F.O headlights include:

Fiber optic technology
Adjustable headband for comfortable fit
Simple set-up and installation
Resistant to most chemicals except methyl ethyl ketones
Maintenance-free design
Minimum shelf-life of 5 years

Product Usage Instructions

Before using the F.O headlights, adjust the helmet to the head
size by using the opposite adjusting screw located at the side of
the device. This allows you to tighten or loosen the
headbands.
Adjust the headband according to the size of your head and wear
the device on your head for operation.
Install the device according to the provided installation
procedure and adjust it for the intended examination.
Place the patient in the right position and switch ON the
device for examination.

Note: Always turn OFF the device and allow it
to cool for a few minutes before disassembly or replacement of any
component.

Cleaning:

Always turn OFF the device before cleaning.
Do not immerse the F.O headlight into sterilizer or
disinfectant liquids as it could cause damage to the device.
Avoid scratching or striking the ends of the fiber cable to
prevent a reduction in light transmission.
Allow the device to dry before use.

Operating Environment:

Humidity Limitation: 75%
Temperature Limitation: 30°C – 95°C
Atmospheric Pressure Limitation: 700 hPa – 1060 hPa

Storage Environment:

Temperature Limitation: 15°C – 30°C
Humidity Limitation: 15% – 95%
Atmospheric Pressure Limitation: 500 hPa – 1060 hPa

If you have any further questions or need assistance, please
refer to the instructions for use or contact the manufacturer.

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1
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 verificatosi 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 office 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 [email protected] – [email protected] www.gimaitaly.com Made in Pakistan

M30853-M-Rev.0-04.22

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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 final 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 defined period. After opening the package, it is necessary to check all the components against standard configuration. 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 fiber 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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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 qualified 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 fibers. – 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 fiber optic cable from the light source when light source is ON. The light guide distal end may transfer extreme heat. Proximal end of fiber 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 fiber so, do not curl or bend the cable more than 60 degrees to avoid any fiber breakage. Note: Always turn OFF the device and keep the it for few minutes for cooling before disassembly and/or replacement of any component.

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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 fiber 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 fibers cable. Reduction in light transmission may occur.

OPERATING ENVIRONMENT:

Temperature Limitation 55°C

Humidity Limitation 75%

10°C

30%

STORAGE ENVIRONMENT:

Temperature Limitation

Humidity Limitation

60°C

95%

Atmospheric Pressure Limitation 1060 hPa
700 hPa
Atmospheric Pressure Limitation 1060 hPa

-20°C

15%

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 fields e.g. MRI scanners. · Any unauthorized modification/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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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

Medical Device compliant with Regulation (EU) 2017/745

Product code
Caution: read instructions (warnings) carefully

Consult instructions for use Lot number

Keep in a cool, dry place Manufacturer Medical Device

WEEE disposal

Data di fabbricazione

Temperature Limitation

% Humidity Limitation

Atmospheric Pressure 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 specific recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.