Hyfrecator 2000 Handpiece Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE

Hyfrecator® 2000 Handpiece: 7-900-5 & 7-900-6 Non-sterile – Reusable - Autoclavable X100

Description:

This Hand or Foot Control Pencil is supplied non-sterile and fits the Hyfrecator® 2000 generator only. This Up/Down Switching device is designed to be used as an accessory with disposable ELECTROLASE® Tips or compatible electrodes. Reusable/sterilizable 100 times as described below. Maximum generator voltage: 5.5 KV peak.

Intended Use:

These devices are reusable hand-switching electrosurgical accessory handpieces used in conjunction with a Hyfrecator electrosurgical generator for delivery of RF electrosurgical current through an accessory electrode for coagulation at the operative site.

Contraindications:

This device should never be used when: • There is visible evidence of damage to the exterior of the device, such as cracks, cuts, punctures, nicks, abrasions, discoloration or connector damage. • Where conventional monopolar electrosurgery is inappropriate or unsafe, such as for small appendages, in circumcision or finger surgery. • In the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases, such as Nitrous Oxide, or in oxygen-enriched environments.

Warning: •

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Do not directly secure the control cable with metal instruments to surgical drapes. Activation of the pencil in contact with metal instruments may cause burns at the tissue/instrument interface. Do not allow device cable to be parallel to or in close proximity to leads of other electrical devices. To avoid burns never allow cable associated with this device to be in contact with skin of patient or touching operator. Prolonged use of the handpiece causes the electrode to become very hot and the tip remains hot for a period after use. Do not allow the tip to come in contact with the patient or others after activation to avoid burns. Do not immerse or saturate handpiece or cord in fluid. Electrosurgery is potentially hazardous for patients with pacemakers, AICDs, neurostimulators or other active implants. High frequency energy may damage or adversely affect active implants. Ventricular fibrillation may occur. Do not pull on or stretch the handpiece cord. Always place associated electrosurgical accessories in a safe insulated location, such as a holster, when not in use, to avoid burns. Use of this device beyond its intended life span will eventually result in failure of the device and present a possible hazard. At that point the device cannot be repaired and should be replaced with a new CONMED Hyfrecator® 2000 handpiece. Care in use and handling can ensure the useful life of this product. Process accessory device through a cleaning and sterilization cycle prior to initial or subsequent use per instructions below.

Caution: •

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Refer to CONMED® Hyfrecator® 2000 Operator's Manual instructions prior to use. Use lowest possible power setting on the CONMED® Hyfrecator® 2000 Electrosurgical Generator and shortest possible activation time capable of achieving the desired surgical effect. After patient use, this product should be considered a potential biohazard and processed as directed below or disposed of per hospital policy and applicable law. The CONMED® Hyfrecator® 2000 Electrosurgical Generator should be used only by surgeons/healthcare practitioners knowledgeable with electrosurgical techniques and safety.

Inspection:

These devices should be inspected before use. Visually examine the devices for obvious physical damage: • Cracked, broken or otherwise distorted plastic parts; • Damage including cuts, punctures, nicks, abrasions, unusual lumps or significant discoloration.

Pre-Cleaning/Disinfection:

Pre-cleaning followed by disinfection may be used if: • The handpiece is used with a Hyfrecator Sheath and sheath remains intact through procedure and subsequent handling; and • The handpiece, not including the electrode, only contacts intact skin. Pre-cleaning: 1. Disconnect the handpiece from the generator and remove the electrode from the handpiece. 2. Using a CaviWipes™ or CaviWipes1™ disinfecting towelette, clean the surface of the handpiece including the section of cord at the proximal end of the handpiece and the distal tip of the handpiece of all gross debris. 3. Discard towelette. Disinfection: 1. Using a CaviWipes™ or CaviWipes1™ disinfecting towelette, thoroughly wet the surface of the handpiece including the section of cord at the proximal end of the handpiece and the distal tip of the handpiece. 2. Ensure the surfaces are visibly wet and remain visibly wet for a minimum of 3 minutes for CaviWipes™ or 1 minute for CaviWipes1™.

Cleaning/Sterilization:

Cleaning followed by steam sterilization is required if the handpiece is used with a sterile sheath and the sheath is compromised during use or during handling post-use, or if the handpiece, not including the electrode, contacts non-intact skin or sterile tissue. Cleaning: 1. Disconnect the handpiece from the generator and remove the electrode from the handpiece. 2. Prepare a neutral or near-neutral pH detergent per manufacturer’s instructions. 3. Remove any obvious debris from all areas of the handpiece and cable using a soft, non-metallic brush and detergent for a minimum of one (1) minute and until visibly clean. Do not immerse the handpiece. 4. Rinse all areas of the handpiece and cable thoroughly with purified water for a minimum of one (1) minute. Do not immerse the handpiece. Sterilization: Place the handpiece in a double muslin wrap or equivalent dual self-sealing peel pouch, and place single layer onto an open tray in a steam autoclave for sterilization. Process using either of the following methods: Steam, Pre-vacuum – Process at 132-135°C (270-275°F) for at least 3 minutes, not to exceed 4 minutes. Recommended drying time is at least 5 minutes at 132-135°C (270-275°F). Steam, Gravity Displacement – Process at 132-135°C (270-275°F) for at least 10 minutes, not to exceed 15 minutes. Recommended drying time is at least 5 minutes at 132-135°C (270-275°F).

Instructions for Use: 1.

2. 3. 4. 5.

Insert an ELECTROLASE® Tip or compatible electrode into the active end of the Hyfrecator® 2000 handpiece, making sure to properly seat the anti-rotation hex of the Tip or electrode into the handpiece. Insert the handpiece SWITCHING CONNECTOR into mating connector on the bottom of the Hyfrecator® 2000. Select the desired output (High or Low) TERMINAL SELECTOR SWITCH. Insert the RF PLUG (Single Pin Accessory Plug) into the HIGH or LOW OUTPUT TERMINAL. Adjust the power setting using the “UP” or “DOWN” buttons on the handpiece (model 7-900-5 only), or the POWER KNOB on the Hyfrecator® generator. Activate the Hyfrecator® 2000 Handpiece by pressing the button closest to the electrode.

Warranty:

CONMED Corporation warrants this product to be free from defects in materials and workmanship under normal operations and use for 12 months or 100 repeated uses, whichever occurs first, as a Hyfrecator® accessory. This warranty does not apply to any product that has been altered or serviced by anyone other than the manufacturer. Nor does it apply toward any product that has been damaged as a result of accident, abuse, misuse or negligence by the user.

USA Federal law restricts this device to sale by or on the order of a physician. Made in Mexico

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