Gima TUNGSTEN NEEDLE ELECTRODE 7 cm, TUNGSTEN NEEDLE ELECTRODE 5 cm User guide

PROFESSIONAL MEDICAL PRODUCTS

ELETTRODI (MONOUSO)

ELECTRODES (SINGLE USE)

30370 - 30371 - 30372 - 30373 - 30374 - 30375 - 30677 - 30679

Tecno Instruments Pvt. Ltd.
316C Small Industrial Estate
Sialkot, 51340 - Pakistan
Made in Pakistan

Obelis s.a.
Bd. General Wahis 53
1030 Brussels (BELGIUM)

Obelis UK, Sandford Gate, East
Point Business Park, OX4 6LB ­Oxford, UK

Importato da/Imported by/ Importé par/
Importiert von/ Importado por/ Importado por/

Εισάγεται αaπό:

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

M30370-M-Rev.0-09.22

1639

40°C

5°C

ENGLISH

Description/Intended Use:

These devices are single use and supplied sterile. 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.

Compatibility:

Electrode Type Instrument Connector ESU Generator Connector

Blade/Ball/Needle/Loop/Conization 2.4mm N/A
Blade/Ball/Plat/Needle/Loop 4.0mm N/A

Recommendations:

Recommended Voltage Shelf Life Operation Environment

1500 Vp 5 Years Temperature: 5°C to 40°C

Humidity: 0% to 90% R.H
Pressure: 70 kPa to 106 kPa

Contraindications:

Incidents which have been reported in connection with the use of bipolar systems:

1. Unintended activation with resulting tissue injury on the wrong spot and/or damage to the
equipment.

2. Alternating current paths leading to burns on spots where the patient or user comes into contact
with components without insulation.

3. In the presence of ammable gases, liquids, and/or oxygen enriched environments.

4. Electrosurgery is potentially hazardous for patients with active implants such as pacemakers,
AICDs and neuro stimulators.

Use and Safety Instructions:

The non-observance of the present use and safety instructions may lead to
injuries, malfunctions, or other unexpected incidents.

1. It is especially important to check each instrument for visible damage and wear, such as cracks,
breaks or insulation defects before each use.

2. Never use damage instruments.

3. Never use the instruments in the presence of ammable or explosive substances.

4. The instrument may not be laid down on the patient.

5. Frequently clean the tips from blood and debris.

6. Coagulation should only be performed if the contact surfaces are visible and ensure a good
contact to the tissue selected for coagulation.

7. Do not touch any other metallic instruments, trocar sleeves, optics or the likes during use.

Side Effects:

There are no side effects, associated with the use of device if use by professional person.

Users:

This device only be used by persons who are specially trained doctors.

Patient population:

This device is suitable for use for children and adult.

Performance Claims:

4

5

ENGLISH

• These medical devices are made of biocompatible material which conforms to ENS ISO 10993-1
standard.

• These medical device conforms to IEC 60601-2-2 standard for electrical safety.

• These medica device conforms to IEC 60601-1 for basic safety & essential requirements.

Prior to Use:

Before connecting electrode with electrodes handle , make sure that the unit has been switched off or is
in standby mode. Disregarding these instructions may lead to burns and electrical shock.

During Use:

Always use the lowest power setting available to achieve the desired surgical effect.

Storage & Handling:

1. These medical devices must be stored in a clean, cool and dry area.

2. Protect from mechanical damage & direct sun light. Handle with extreme care.

Symbols:

Caution: read instructions (warnings)
carefully

Keep in a cool, dry place Date of manufacture

Manufacturer Product code

Lot number

Medical Device complies
with Directive 93/42/EEC

Temperature limit Expiration date

Sterilized using ethylene oxide Consult instructions for use

Authorized Representative in the UK

Keep away from sunlight

Authorized representative
in the European community

Disposable device, do not re-use

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.