Geister Bipolar Forceps Instructions for Use

MEGADYNE™

ENGLISH

BIPOLAR FORCEPS 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:

These devices are designed for at least 20 repeated uses when utilized in accordance with the validated instructions contained herein. Care in use and handling can extend the useful life.

WARNINGS:

These devices should never be used when: 1. There is visible evidence of damage to the exterior of the device such as cracked plastic or connector damage. 2. These devices fail the inspection described herein. 3. In the presence of flammable gases, liquids and/or oxygen enriched environments.

SAFETY TIPS:

1. Use lowest possible power setting on electrosurgical unit capable of achieving desired surgical effect. 2. Never allow the cables connected to these devices to be in contact with skin of the patient or operator during electrosurgical activations. 3. Do not permit the cables connected to these devices to be parallel and in close proximity to the leads of other electrical devices. 4. 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. 6. Discard devices that have reached their life expectancy. 7. 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: 1. Cracked, broken or otherwise distorted plastic parts. 2. Broken or significantly bent connector contacts. 3. Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration. 4. 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 purified water solution or use a mechanical washer. Rinse thoroughly with purified water until free of detergent residual and debris, then thoroughly dry using a clean wipe (do not fully immerse in fluids).

PRECAUTIONS: 1. 2. 3. 4. 5.

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 forceps separately or place in a container so as to prevent the forceps from contacting each other or other instruments. Steam: Gravity Steam autoclave at 250°F (121°C) for 20 minutes. Prevac Cycle: Steam autoclave at 272°F (133°C) for 4 minutes, 20 minutes dry. Flash: Steam autoclave at 275°F (134°C) for 10 minutes. Gas(EtO): Follow manufacturer’s guide for the unit which you are using. For maximum life of the product EtO sterilization is recommended.

WARRANTY:

These products are guaranteed against material and workmanship. The warranty is null and void should damage occur as a result of improper handling use. Care must be taken in the use and reprocessing of these products. RF Voltage Rating ≤ 475 V peak, consult electrosurgical generator specifications.

Storage Conditions: Temperature: 5°C to 50°C Relative Humidity: 15% to 95% Storage and Transport Conditions: Keep dry Keep away from heat

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