GIMA 30315 Professional Medical Bipolar Cables Instructions
- July 20, 2024
- GIMA
Table of Contents
GIMA 30315 Professional Medical Bipolar Cables
Product Information
Specifications:
- Manufacturer: Tecno Instruments Pvt. Ltd.
- Origin: Pakistan
- Importer: Gima S.p.A., Italy
- Reusable, non-sterile cables
- Designed for connecting bipolar forceps/accessories to the electrosurgical generator
Product Usage Instructions
Description/Intended Use:
The cables are designed to connect bipolar forceps/accessories to an
electrosurgical generator for conducting electrosurgical current during
surgical procedures.
Reuse:
The cables can withstand a minimum of 100 sterilization cycles. Clean and
sterilize before initial use. Proper care can extend the useful life of the
product.
Safety Tips:
- Only qualified doctors specialized in electro-surgery techniques should use the product.
- Avoid contact with non-insulated devices.
- Incorrect use or maintenance can lead to quick deterioration.
Cleaning:
Use a soft, non-metallic instrument and mild detergent with sterile water for
cleaning. Thoroughly rinse and dry with sterile wipes. Do not fully immerse in
fluids.
Sterilization:
Sterilize the cables according to the validated instructions provided. Ensure
proper cleaning before sterilization.
Storage & Handling:
Store in a clean, cool, and dry area. Protect from mechanical damage and
direct sunlight. Handle with care to prevent damage.
FAQ:
-
Q: How many sterilization cycles can the cables withstand?
A: The cables are guaranteed to withstand a minimum of 100 sterilization cycles when sterilized according to validated instructions. -
Q: Can the cables be disposed of with regular domestic waste?
A: No, the product must be disposed of at specific recycling points for electric and electronic equipment to ensure proper disposal.
FEATURES
The GIMA bipolar cables are devices used with bipolar electro-surgery devices. The cables are made of light and flexible silicone, they are 3 meters long and can be sterilized in an autoclave up to 135°. They have a universal connection that makes them easy to use with other GIMA devices and with most of the electric scalpels produced in Europe.
INFORMATION
The product is designed to be used only by qualified doctors, specialize in
electro-surgery techniques and the maintenance of this type of product. The
incorrect use or poor or inappropriate maintenance can make the product
deteriorate quickly.
These products can cause injuries if not used correctly! Do not put in contact with devices that are not insulated! The electric scalpels used together with these cables will destroy tissues and are extremely dangerous if used incorrectly.
DESCRIPTION/INTENDED USE
These cables are reusable and are supplied non-sterile. Process through cleaning and sterilization prior to initial use. These cables are designed to connect bipolar forceps/accessories at one end and electro-surgical generator with which they are known to be compatible at the other end. Their use enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the bipolar forceps to the operative site for the desired surgical effect.
REUSE
We guarantee our products to withstand a minimum of 100 sterilization cycles
when sterilized in accordance with the validated instructions contained
herein. Care in use and handling can extend useful life.
CONTRAINDICATIONS
These devices should never be used when:
- There is visible evidence of damage to the exterior of the device such as cracked plastic or connector damage.
- These devices fail the inspection described herein.
- In the presence of flammable gases, liquids, and/or oxygen-enriched environments.
SAFETY TIPS
- Use lowest possible power setting on an electrosurgical unit capable of achieving the desired surgical effect.
- Never allow the cables connected to these devices to be in contact with skin of the patient or operator during electrosurgical activations.
- Do not permit the cables connected to these devices to be parallel and near the leads of other electrical devices.
- Always place unused electrosurgical accessories in a safe insulated location such as a holster when not in use.
- Inspect and test each device before each use.
- Discard devices that have reached their life expectancy.
INSPECTION
It is recommended to establish a procedural review, by which the cable’s
electrical continuity is regularly tested with an ohmmeter as well as frequent
inspection of the cord’s insulation before and after each use for cracks,
nicks, lacerations, or abrasions, and by which a criterion is set for the
discarding and replace-ment of those cords which may be worn and hazardous to
the patient and operating room personnel. These devices should be inspected
before and after each use. Visually examine the devices for obvious physical
damage including:
- Cracked, broken or otherwise distorted plastic parts.
- Broken or significantly bent connector contacts.
- Damage includes cuts, punctures, nicks, abrasion, unusual lumps, and significant discoloration.
- Tips for damage, corrosion or misalignment condition.
CLEANING
Remove any obvious debris accumulated during use from the device with a soft,
non-metallic instrument cleaning brush plus mild detergent and sterile
purified water solution.
Rinse thoroughly with sterile, purified water until free of detergent residual
and debris, then thoroughly dry using a sterile wipe, (Do not fully immerse in
fluids).
PRECAUTIONS
- Do not scrape or scrub coated surface with abrasives.
- Do not use cervical brush to clean smoke tube.
- Do not overlap instruments in the sterilization tray.
- Do not soak coated instruments in CIDEX or other caustic cold sterilization solutions.
- Do not use bleach.
- Do not place coated instruments in an ultrasonic cleaner.
STERILIZATION
Wrap each pair of instruments separately or place in a container to prevent
instruments from contacting each other or other instruments.
- Steam: Steam autoclave at 250°F (121ºC) for 30 minutes.
- Flash: Steam autoclave at 275°F (134ºC) for 10 minutes.
- Gas (ETO): Follow the manufacturer’s guide for the unit that you are using.
- Pre-Vac: Steam autoclave at 270°-273°F (132°-135°C),
Exposure Time (4 minutes), Dry Time (20 minutes)
Do not handle the device until they are thoroughly cooled. For maximum life of
the product ETO sterilization is recommended.
STORAGE & HANDLING
Electrosurgical Cables must be stored in a clean, cool and dry area. Protect from mechanical damage & direct sunlight. Handle with extreme care.
Index of symbols
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.
REF: 30315 – 30325 – 30617 – 30618 – 30632 – 30637 – 30638 – 30639 – 30640 – 30643 – 30644
Tecno Instruments Pvt. Ltd.
316C Small Industrial Estate
Sialkot, 51340 – Pakistan
Made in Pakistan
CMC MEDICAL DEVICES & DRUGS, S.L C/ Horacio Lengo n18
C.P 29006 – Málaga-Spain
Imported by:
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com
export@gimaitaly.com
www.gimaitaly.com
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