ConMed hyfrecator 2000 Operator's Manual

Operator’s Manual
2000
Serving the Physician Since 1937
R
© 1998 CONMED Corporation
310 Broad Street
For Technical Services or Return Authorization Phone:
303-699-7600 / 1-800-552-0138 Extension 5274
Fax 303-699-9854
For Customer Services or to order parts phone:
1-800-448-6506 / 315-797-8375 / Fax 315-735-6235
or contact your CONMED Representative.
European Authorized Representative
MDSS GmbH
Burckhardtstr 1
D - 30163 Hannover
Germany
The revision level of this manual is specified by the
highest revision letter found on either the inside front
cover or enclosed errata pages (if any).
Manual Number 7-900-OM-ENG Rev. -
Unit Serial Number ____________________________
Sheet 1 of 1
MANUAL ERRATA MODEL: Hyfrecator 2000 MANUAL P/N: 7-900-OM-ENG
REVISION LEVEL: C CO NO.: 10484 DATE: 08/10/2007
EFFECTIVITY: All units
DESCRIPTION: Make the following changes to the Hyfrecator 2000 Operator Manual (English):
Changed corporate address shown on inside front cover.
• WAS:
…310 Broad St.
Utica, New York 13501…
• NOW:
Utica, New York
525 French Road
13502
Changed European sales address shown on inside front cover.
• WAS:
…MDSS GmbH Burckhardstr 1 D – 30163 Hannover…
• NOW:
…MDSS GmbH Schiffgraben 41 D –
30175 Hannover…
The revision level of this manual is specified by the highest revision
letter found on either the inside front cover or enclosed ERRATA pages.
FORM 900-328 REV. - 12/87
MANUAL ERRATA MODEL: Hyfrecator 2000 MANUAL P/N: 7-900-OM-ENG
REVISION LEVEL: B ECN NO.: 8431 DATE: 7/21/04
EFFECTIVITY: All units.
NOTE: This errata supercedes errata revision A, previously released.
DESCRIPTION:
Pages 17 - 18, Section 9 - Maintenance; subsection “Sterilization of Accessories” is revised as follows:
Delete all existing text in this section and replace with: “For sterilization of Hyfrecator accessories, refer to the Instructions for Use insert included with the accessory. NOTE: It is not advisable to cold sterilize surgical electrodes due to potential corrosion. NOTE: Non-sterile Electrolase® Tips are not validated for sterilization. Do not attempt to sterilize these tips. NOTE: Do not sterilize the footswitch (Cat. No. 7-900-4).
Page 19, Section 10 - Optional Accessories, Item 6 is revised as follows: Change “(Cat. No. 7-800-6)” to “(Cat. No. 7-900-6)”.
Page 19, Section 11 - Warranty is revised as follows:
Change “A ninety (90) day warranty is provided for standard and optional accessories.” to “A ninety (90) day warranty is provided for standard and optional accessories except as defined in the Instructions for Use included with the accessory.”
Delete “The ninety (90) day warranty includes the power up/down switching handle and cord.”
The revision level of this manual is specified by the highest revision
letter found on either the inside front cover or enclosed ERRATA pages.
FORM 900-328 REV. - 12/87
Table of Contents
- Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
2 Safety Precautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
3 Operating Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
4 Operation of Your Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
5 Suggestions for First-Time Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
6 Terminology for Systems Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
7 Terminology for Procedural Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
8 Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
9 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
10 Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
12 In Case of Difficulty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
13 Repair and Return Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
14 Environmental Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
15 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
16 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
17 Index of Reference Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
18 Performance Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Section Title Page
2000
1 Front, Side and Bottom Panel Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2 Back Panel Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3 Monoterminal Without a Dispersive Plate Configuration . . . . . . . . . . . . . . . . . . . . . .8
4 Monoterminal with Dispersive Plate Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . .9
5 Bipolar Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
6 Desiccation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
7 Epilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
8 Fulguration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
9 Monoterminal Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
10 Bipolar Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
11 Peak Voltage vs. Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
12 Power Out vs. Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
13 Load Regulation Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Figure Title Page
2000
This page intentionally left blank.
2000
1
Introduction
Congratulations on your purchase of the CONMED HYFRECATOR® 2000 . The HYFRECATOR® was introduced in 1937 and has become the world leader in office-based electrosurgery. With the latest model, the HYFRECATOR® 2000, CONMED has refined the concept and utilized today’s technology to produce the finest machine of its kind.
Safe and simple to use, the HYFRECATOR® 2000 has a wide range of applications - from dermatology and gynecology to ophthalmology and urology. The HYFRECATOR® 2000’s state of the art electronic circuitry utilizes two microprocessors to provide unsurpassed output power accuracy and patient safety. Whether it’s full power for broad surface coagulation, or low power in one-tenth watt increments for delicate facial procedures, the HYFRECATOR® 2000 provides the precision you demand. Internal self-diagnostic tests are performed every time you turn on the HYFRECATOR® 2000 and the power output is monitored continuously during operation. This makes the HYFRECATOR® 2000 one of the safest office-based electrosurgery units in the world. Compatible with your existing HYFRECATOR® accessories, such as bipolar forceps and reusable electrodes, the HYFRECATOR® 2000 features an ergonomic design and contemporary style that complements modern office decor.
Section 1 - Inspection
The CONMED HYFRECATOR® 2000 has been thoroughly tested and inspected before shipment from the factory. Please check the unit before using for any damage that may have occurred in transit to you. If any damage is evident, please immediately contact the Authorized CONMED Distributor from whom you purchased the unit.
In addition, please compare the accessories you receive with the standard accessories listed below. If an item is missing, please notify your CONMED Distributor.
To activate your warranty, return the enclosed warranty card to CONMED Corporation within 10 days of receipt of your invoice.
Standard Accessories
Description Catalog Number
Starter box of Non-Sterile, Electrolase® Blunt Tips 7-101-12 Starter box of Non-Sterile, Electrolase® Sharp Tips 7-100-12 Power Up\Down Switching Handle and Cord 7-800-5 Non-Sterile Sheaths 7-796-18 Sterile Sheaths 7-796-19 Wall Mount Kit 7-796-20 Operator’s Manual and Warranty Card 7-900-OM Common Dermatologic Procedures Videotape 7-900-21
Section 2 - Safety Precautions and Warnings
Users are warned against the use of the HYFRECATOR® 2000 on patients with implants such as metal pins, metal joints, etc. Check with attending physician for patient’s medical history before using the HYFRECATOR® 2000.
The use of the HYFRECATOR® 2000 on patients with cardiac pacemakers is potentially hazardous. The high frequency energy of the HYFRECATOR® 2000 output may interfere with the action of the pacemaker. Precautions should be taken to ensure that the patient’s well-being is maintained in the event of such interference. We recommend that the manufacturer of the pacemaker be consulted for advice before using the HYFRECATOR® 2000 on a patient with a pacemaker. These precautions also apply to clinical personnel with cardiac pacemakers.
2000
2
Electrosurgery should NEVER be performed in the presence of flammable anesthetics, flammable prep solutions or drapes, oxidizing gases such as Nitrous Oxide (N2O), or in oxygen-enriched environments. The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Precautions must be taken to restrict flammable materials and substances from the electrosurgical site, whether they are present in the form of an anesthetic, life support, skin preparation agent, or are produced by natural processes within body cavities, or originate in surgical drapes, tracheal tubes, or other materials. There is a risk of pooling of flammable solutions in body depressions such as the umbilicus and in body cavities, such as the vagina. Any excess fluid pooled in these areas should be removed before the equipment is used. Attention should be called to the danger of ignition of endogenous gases. Some materials, for example, cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the Hyfrecator ® 2000.
To avoid alternate site burns or potential shock, remove all metal objects from treatment area before using the HYFRECATOR® 2000. It is not advisable to use this instrument in the proximity of jewelry, eyeglasses, digital watches, portable radios, pocket calculators, hearing aids, etc.
Do not use monopolar electrosurgery on small appendages or other parts of the body having a relatively small cross sectional area, as in circumcision or finger surgery, as it can cause thrombosis and other unintended injury to tissue proximal to the surgical site. IEC 60601-2-2 (3rd Edition) indicates the use of bipolar techniques may be desirable for use in those situations in order to avoid unwanted coagulation. Note, however, that AAMI Standard HF18-1993 currently contraindicates both monopolar and bipolar electrosurgery for circumcisions.
The tips of recently activated accessories may be hot enough to burn the patient or ignite flammable material. Temporarily unused active electrodes should be stored in the holder on the Hyfrecator® 2000 or in an electrically insulated, flame resistant container to prevent injury due to hot tips or accidental activation of the footswitch. The unused active electrode should never be placed on the patient.
The output power selected should be as low as possible and activation times should be as short as possible to achieve the desired surgical effect.
Electrosurgical leads (active, bipolar or return) should not be allowed to contact the patient, staff, or other electrical leads connected to the patient.
When uncertain of the proper control setting for the power level in a given procedure, start with a low setting and increase as required.
Do not place liquid containers on top of the unit. Wipe spilled liquids off the unit immediately. To prevent inadvertent entry of liquids, do not operate this unit except in its normal upright position.
To prevent cross-infection, do not reuse disposable (single use) accessories. Used electrosurgical tips should be disposed of as sharp biological hazards per your local and hospital regulations. Studies have shown that smoke generated during electrosurgical procedures may be harmful to
surgical personnel. These studies recommend using a surgical mask and adequate removal of the smoke using a surgical smoke evacuator or other means.
Interference produced by the operation of the Hyfrecator® 2000 may adversely influence the operation of other electronic equipment.
Regularly inspect accessories for damage. In particular, electrode cables and endoscopically used accessories should be checked for possible damage to the insulation.
Use only accessories that have been approved for use with the Hyfrecator® 2000. Do not use accessories that fail to meet the minimum peak voltage requirements per Fig 11 , Peak Voltage vs. control settings. It is recommended to use only accessories rated at the maximum peak voltage, for a given mode.
2000
3
Anesthesia
As in other types of surgery, the amount and type of anesthetic required for procedures depends upon the site of the operation and the tolerance of the patient. Small lesions can sometimes be removed without anesthetics when they are not in sensitive areas. Do not use explosive or flammable anesthetics due to the presence of the spark created by the HYFRECATOR® 2000. Similarly, when the site is cleaned with alcohol or other flammable cleansing agents, dry the surface thoroughly before proceeding.
Monoterminal Shock
In all electrical devices where a current is emitted from the instrument, the current must have a return path. The return path for monoterminal applications is through the patient’s body, to the ground and back to the instrument. In this mode, if any portion of the patient’s body comes in contact with a grounded metal object, such as a chair or metal rail, the current will take the path of least resistance and a slight shock may be felt. To minimize the possibility of shocking during monoterminal applications:
• Do not let your patient come in contact with any grounded metal objects.
• Position the electrode on or close to the patient before activating the output.
• For procedures using the dispersive plate, do not allow the patient to break contact with the dispersive plate when the unit is activated.
• If the physician or nurse must touch the patient, place hand on the patient before activating the HYFRECATOR® 2000. Do not break contact during activation. To lessen the possibility of a shock, wear gloves at all times and continue to avoid contact with grounded metal objects.
Failure of the unit could result in an unintended increase of output power. When used, the neutral electrode (patient plate) should be reliably attached with the entire surface
area in contact with the patient’s body and as close to the operating field as possible. When not in use, the neutral electrode should be disconnected from the Hyfrecator® 2000 to avoid accidental burns.
Apparent low output or failure of the Hyfrecator® 2000 to function correctly at normal operating settings may indicate a faulty green wire ground connection. This could be due to a faulty power cord, loose connections inside the unit, the use of a two wire extension cord, or the use of a three-to­two prong adapter. These faults can result in a burn if the patient plate is used and is not in good contact with the patient. If the neutral electrode (patient plate) is being used, the low power may be due to faulty application or poor contact in its connections. In this case, the application of the neutral electrode and it’s connections should be checked before selecting a higher power.
Skin to skin contact (for example, between the arms and body of the patient) should be avoided by the insertion of dry gauze or other suitable means.
When the Hyfrecator® 2000 and physiological monitoring equipment is used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended. In any case, monitoring systems incorporating high frequency current limiting devices are recommended.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N
2
0) and oxygen (02) should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away or flammable anaesthetic-proof equipment is used. The Hyfrecator® 2000 is not flammable anaesthetic-proof equipment.
Do not use the Handswitched Pencil with a footswitch. The unconnected switch connector can arc to nearby objects or personnel and cause a burn.
Connect the generator electrical cord to a properly grounded receptacle. Do not use extension cords or two wire adapters.
Do not connect wet accessories to the generator. The Hyfrecator® 2000 must be mounted vertically to reduce the possibility of spilled liquids entering
the chassis and adversely affecting the safety of the unit.
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