GIMA 30853 F.O. Head Light Instructions
- June 12, 2024
- GIMA
Table of Contents
GIMA 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.
All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and com-petent authority of the member state where your registered office is located
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com –
export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan.
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 an ergonomic headband, which is padded and fully adjustable in circumstances and height
- Superior comfort, durability and adjustability
- Headband cleaning made easier by removable and washable padding
- Double lens precision optical with an adjustable holder to focus the light point
- Illumination axis adjustable over wide range
- 3.5mm fiber optic bundle cable length 2.3 meter
- Connectors 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
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.
- Adjust the head band according to heads size and wear the device on head for operation
- Install the device according to the installation procedure and adjust the device for intended examination
- 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 professionals 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 the headlight when illuminated. It can compromise 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. The 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
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.
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
STORAGE ENVIRONMENT:
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
SHELF-LIFE:
The product has been conceived to last longer. However, the minimum shelf-life
of these devices is 5 years.
SYMBOL INFORMATION
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.
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