CONMED Hyfrecator Electrolase Disposable Electrodes Instruction Manual
- June 12, 2024
- CONMED
Table of Contents
CONMED Hyfrecator Electrolase Disposable Electrodes Instruction Manual
Hyfrecator® Electrolase® Disposable Electrodes
7-100-12 = Sharp Tips
7-101-12 = Blunt Tips
Non-sterile — Non-reusable
Description
Single use devices designed for use with Hyfrecator® 2000 Pencil Accessories. Non-sterile Electrolase Tips should be used when a ‘hospital clean’ environment is satisfactory.
Intended Use
The Hyfrecator Electrolase Disposable Electrodes are to be used as active RF electrodes for coagulation. The Electrolase” Sharp Tip electrode is ideal to achieve pinpoint coagulation of tissue; the Electrolase® Blunt Tip electrode is ideal for broad based coagulation. Maximum generator voltage: 5.5kVpk.
Contraindications
These devices 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 circumdision 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
- To prevent accidental burns, do not activate generator until electrode is secure and in position to deliver energy to target tissue. Turn off generator before attempting to remove electrode. After prolonged activation allow the electrode tip to cool.
- Do not test the device by sparking the active electrode to the patient plate or other objects.
- 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.
- Always place associated electrosurgical accessories in a safe insulated location, when not in use, to avoid burns.
- Process accessory device through a sterilization cycle prior to initial use per instructions below.
Precaution
- Refer to CONMED® Hyfrecator® 2000 Operator’s Manual and CONMED® Hyfrecator® handpiece instructions prior to use.
- Non-sterile Electrolase Tips are not validated for sterilization. Do not attempt to sterilize these tips.
- SINGLE PATIENT USE. DO NOT RESTERILIZE. The ability to effectively clean or re-sterilize this disposable device has not been established. Subsequent re-use may adversely affect performance and safety.
- 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 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 and discard if found:
- Cracked, broken or otherwise distorted plastic parts;
- Damage including cuts, punctures, nicks abrasions, unusual lumps or significant discoloration.
Instructions for Use
- Note: Electrolase® Tips, 7-100-12 Sharp Tips & 7-101-12 Blunt Tips, are supplied non-sterile. Sterile Electrolase® Tips are available as part number 7-100-8 Sharp Tips and 7-101-8 Blunt Tips as shown in catalogue.
- Attach electrode to CONMED® Hyfrecator® 2000 handpiece. Electrodes can be removed! reattached to handpiece as needed during procedure.
- Activate and deactivate the Hyfrecator® 2000 Electrolase® electrode by using the switching mechanism on the handpiece or footswitch.
USA Federal law restricts this device to sale by or on the order of a physician.
Made in U.S.A.
S525 French Road • Utica, NY 13502-5994 USA
315-797-8375 • FAX
315-797-0321
Customer Service (USA) 1-866-426-6633
e-mail: CustomerExperience@conmed.com
http://www.conmed.com
© CONMED Corporation, Printed in U.S.A.
EC/REP
European Authorized Representative
MDSS GmbH
Schiffgraben 41
D – 30175 Hannover
Germany
For International orders or inquiries, please contact
CONMED International Sales
315-797-8375 • FAX
315-735-6235
P/N 62-8486-001 REV. B 06/2021
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