Gima LOOP ELECTRODE 20 x 10 mm, LOOP ELECTRODE 15 x 8 mm User guide

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ENGLISH
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.
We guarantee our products to withstand a minimum of 20 sterilization cycles when sterilized in accord­ance with the validated instructions contained herein. Care in use and handling can extend useful life.
Contraindications
These cables 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 cables 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 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 cable before each use.
• Discard cables that have reached their life expectancy.
• Activation of an electrosurgical device when not in contact with target tissue or in position to deliver energy to target tissue (fulguration) may cause capacitive coupling.
Inspection
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 signicantly bent connector contacts.
• Damage including cuts, punctures, nicks, abrasion, unusual lumps, signicant discoloration.
• Tips for damage, corrosion or misalignment condition.
Cleaning
Remove any obvious debris accumulated during use from the cable with a soft, non-metallic instrument cleaning brush plus mild detergent and sterile puried water solution. Rinse thoroughly with sterile, puried water until free of detergent residual and debris, then thoroughly dry using a sterile wipe. (Do not fully immerse in uids).
Precautions
• Do not scrape or scrub the cables with abrasives.
• Do not overlap the cables in sterilization tray.
• Do not soak the cables in CIDEX or other caustic cold sterilization solutions.
• Do not use bleach.
• Do not place the cables in ultrasonic cleaner.
ENGLISH
Sterilization
Wrap each pair of cable separately or place in a container so as to prevent them 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 cables until they are thoroughly cooled after sterilization. For maximum life of the product ETO sterilization is recommended.
Storage & Handling
Bipolar cables must be stored in a clean, cool and dry area. Protect from mechanical damage & direct sun light. Handle with extreme care.
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Caution: read instructions (warnings) carefully
Keep in a cool, dry place Keep away from sunlight
Manufacturer Date of manufacture
Product code Lot number
Medical Device complies with Directive 93/42/EEC
Non-sterile Temperature limit
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
30605 - 30606 - 30607 30686 - 30687 - 30688
Tecno Instruments Pvt. Ltd. 316C Small Industrial Estate Sialkot, 51340 (PAKISTAN)
Obelis s.a. Bd. General Wahis 53 1030 Brussels (BELGIUM)
Authorized representative in the European community
Consult instructions for use
1639
Importato da / Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M30605-M-Rev.0-07.20
30°C
5°C
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