Gima 30460, 30461, 30462, 30464, 30465 User guide

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PINZE BIPOLARI BIPOLAR FORCEPS FORCEPS BIPOLAIRES BIPOLARE PINZETTEN PINZAS BIPOLARES PINÇAS BIPOLARES
ΔΙΠΟΛΙΚΈΣ ΛΑΒΙΔΈΣ
30460 - 30461 - 30462 - 30464 - 30465 - 30468 - 30469 - 30472 30473 - 30474 - 30620 - 30621 - 30622 - 30623 - 30645 - 30646 30647 - 30648 - 30649 - 30650 - 30651 - 30652 - 30653 - 30654 30655 - 30656 - 30657 - 30658 - 30659 - 30660 - 30661 - 30662 30663 - 30664 - 30665 - 30666 - 30667 - 30668 - 30669
Tecno Instruments Pvt. Ltd. 316C Small Industrial Estate Sialkot, 51340 (PAKISTAN)
Importato da / Imported by / Importé par / Importado por:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy [email protected] - [email protected]
www.gimaitaly.com
M30650-M-Rev.7-07.20
1639
Obelis s.a. Bd. General Wahis 53 1030 Brussels (BELGIUM)
30°C
5°C
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Description/Intended Use
These devices are reusable and are supplied non-sterile. Process through cleaning and sterilization prior to initial use. These devices are designed to be used as accessories in conjunction with those cables and electrosurgical units with which they are known to be compatible. Their use enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit and accessory cables to the operative site for the desired surgical effect.
Reuse
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 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.
• 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 device 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 im-
merse in uids).
Precautions
• Do not scrape or scrub coated surface with abrasives.
• Do not use cervical brush to clean smoke tube.
• Do not overlap instruments in sterilization tray.
• Do not soak coated instruments in CIDEX or other caustic cold sterilization solutions.
• Does 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.
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• 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
Bipolar Forceps must be stored in a clean, cool and dry area. Protect from mechanical damage & direct sun light. Handle with extreme care.
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.
Authorized representative in the European community
Consult instructions for use
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