ClearVac with Optional Handpiece Instructions for Use Rev B Nov 2022

ENGLISH/INSTRUCTIONS FOR USE

CONMED® ClearVac™ Smoke Evacuation with Optional Electrosurgical Handpiece Description/Intended Use:

These devices are designed to be used as accessories in conjunction with those electrosurgical units and electrodes with which they are known to be compatible. The ClearVac™, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The electrosurgical pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Maximum voltage is not to exceed 5.5 KV peak. WARNING: This device is only designed to remove smoke plume. Do not aspirate liquids with this device.

Contraindications:

These devices should never be used when: • • • •

There is visible evidence of damage to the exterior of the device such as cracked or damaged plastic or connector damage. These devices fail the inspection described herein. In the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as Nitrous Oxide (N2O), or in oxygen-enriched environments. Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery.

Safety Tips: •

• • • •

Use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect. Activation time should be as short as possible. 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 associated electrosurgical accessories in a safe insulated location such as a holster when not in use. Inspect and test each device before use.

Inspection:

These devices should be inspected before each use. Visually examine the devices for obvious physical damage including: • • • •

Cracked, broken or otherwise distorted plastic parts. Broken or significantly bent connector contacts. Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration. Verify that the electrode is fully and securely seated in the handpiece before use.

CAUTION: Remove tip protector from handpiece prior to use. Sterility guaranteed unless package has been opened, broken or damaged.

Instructions for Use:

1. Attach CONMED® ClearVac™ to CONMED® pencil, or verify proper attachment as appropriate. 2. Connect hand controlled connector into active hand switching receptacle on generator, or connect foot controlled connector into foot controlled receptacle or adapter on generator (as appropriate). 3. Connect the end of the Electrosurgical Smoke Evacuation Tubing to the CONMED® Filter, or to an equivalent smoke evacuator. Be sure to route the tubing away from heavily traveled areas; the drape clip may be used to route tubing if needed. NOTE: Adapters are available for some devices. See the CONMED Electrosurgery Catalog or website for details. 4. Activate the pencil by depressing the Cut or Coag button on the hand controlled pencil, or by depressing the Cut or Coag pedal if using the foot controlled pencil. 5. After use, this product may be a potential biohazard. Handle and dispose of as required by hospital policy and applicable law. SINGLE PATIENT USE. DO NOT RESTERILIZE. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

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