Gima 30617 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
CAVI BIPOLARI
BIPOLAR CABLES
CABLES BIPOLAIRES
ZWEIPOLIGE KABEL
CABLES BIPOLARES
FIOS ELÉTRICOS BIPOLARES
ΔΙΠΟΛΙΚΑ ΚΑΛΩΔΙΑ
KABLE DWUBIEGUNOWE
CABLURI BIPOLARE
M30617-M-Rev.2-07.19
PROFESSIONAL MEDICAL PRODUCTS
Tecno Instruments Pvt. Ltd.
316C Small Industrial Estate
Sialkot, 51340 (PAKISTAN)
Manuale d’uso - User manual
Manuel de l’utilisateur - Gebrauchsanweisung
Guía de Uso - Guia para utilização
Οδηγίες χρήσης -
Instrukcja obsługi - Manual de utilizare
30617 / 30618 / 30637 / 30638 / 30639
30640 / 30632 / 30643 / 30644
0120
Obelis s.a.
Bd. General Wahis 53
1030 Brussels (BELGIUM)
Importato e distribuito da/Imported and distributed by:
Gima S.p.A. - Via Marconi, 1
20060 Gessate (MI) Italy
ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely understand the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit.
ACHTUNG: Die Bediener müssen vorher dieses Handbuch gelesen und verstanden haben, bevor sie das Produkt benutzen.
ATENCIÓN: Los operadores tienen que leer y entender completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o produto.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
UWAGA: Przed użyciem produktu, operator musi w całości przeczytać i zrozumieć niniejszą instrukcję.
ATENȚIE: Operatorii trebuie să citească și să înțeleagă complet acest manual înainte de a utiliza produsul.

4
ENGLISH
FEATURES
The GIMA bipolar cables are devices used with bipolar electro-surgery devices. The cables are made of
light and exible 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 qualied 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 devices are reusable and are supplied non-sterile. Process through cleaning and sterilization prior
to initial use.
Before using the device make sure the cables are fully compatible with the electro-surgical devices.
Connect the connectors to the chosen surgical device and then the feeding device and verify that the
connections are correct and that no metallic parts are left exposed. Do not bending the cable or x it in
any way with clips or similar devices that could damage its function¬ality.
REUSE
We guarantee our products to withstand a minimum of 20 sterilization cycles when sterilized in accord-
ance 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.

5
• 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 immerse 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.
• 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 contact-
ing each other or other instruments.
• Steam: Steam autoclave at 250°F (121ºC) for 20 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 sterili-
zation 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
Authorized representative in the European
community
Non-sterile WEEE disposal
ENGLISH

6
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 specic recycling point for electric and electronic
equipment. For further information on recycling points contact the local authorities, the local
recycling center or the shop where the product was purchased. If the equipment is not disposed
of correctly, nes or penalties may be applied in accordance with the national legislation and
regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high qualitative standards both as
regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected
parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not extend the warranty. The
warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original
spare parts, defects caused by negligence or incorrect use.
GIMA cannot be held responsible for malfunctioning on electronic devices or software due to outside
agents such as: voltage changes, electro-magnetic elds, radio interferences, etc. The warranty is void if
the above regulations are not observed and if the serial code (if available) has been removed, cancelled
or changed. The defected products must be returned only to the dealer the product was purchased from.
Products sent to GIMA will be rejected.
ENGLISH