PROFESSIONAL MEDICAL PRODUCTS
CAVI MONOPOLARI
MONOPOLAR CABLES
CABLES MONOPOLAIRES
EINPOLIGE KABEL
CABLES MONOPOLARES
FIOS ELÉTRICOS MONOPOLARES
ΜΟΝΟΠΟΛΙΚΟ ΚΑΛΩΔΙΑ
KABLE MONOPOLARNY
CABLURI MONOPOLARE
30609
Tecno Instruments Pvt. Ltd.
316C Small Industrial Estate
Sialkot, 51340 (PAKISTAN)
Importato da/Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M30609-M-Rev.0-08.20
1639
Obelis s.a.
Bd. General Wahis 53
1030 Brussels (BELGIUM)
30°C
5°C
ENGLISH
INFORMATION
The product is designed to be used only by qualied doctors, specialized 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 electrosurgical 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 ammable gases, liquids, and/or oxygen enriched environments.
SAFETY TIPS
• Use lowest possible power setting on electrosurgical unit capable of achieving 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 in close proximity to 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 replacement 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 signicantly bent connector contacts.
• Damage including cuts, punctures, nicks, abrasion, unusual lumps, signicant 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 puried water solution.
Rinse thoroughly with sterile, puried water until free of detergent residual and debris, then thoroughly
dry using a sterile wipe, (Do not fully immerse in uids).
4
5
ENGLISH
PRECAUTIONS
• Do not scrape or scrub coated surface with abrasives.
• Do not overlap instruments in 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 ultrasonic cleaner.
STERILIZATION
Wrap each pair of instrument separately or place in a container so as to prevent instrument 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 manufacturer’s guide for the unit which 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 sun light. Handle with extreme care.
Index of symbols
Caution: read instructions (warnings) carefully Follow instructions for use
Keep in a cool, dry place Keep away from sunlight
Manufacturer Date of manufacture
Lot number Product code
Medical Device complies
with Directive 93/42/EEC
Non-sterile WEEE disposal
Temperature limit
Authorized representative
in the European community
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.
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