PerFect TCS II Owners Guide Rev J

Owners Guide

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Owner’s Guide

Refer to Section 3 for a formal statement of intended use.

Table of Contents 1. Introducing PerFect Tissue Contouring System How does monopolar electrosurgery work?...4 2. Preparing PerFect TCS II for use Unpacking and setting up the unit...4 Activating the unit...4 Preoperative practice...5 Cutting practice...5 Coagulation practice...5 General principles of electrosurgery technique...5 Placement of equipment...5 The dispersive electrode...5 The cutting stroke...5 3. Clinical Guide to PerFect TCS II Indications for use...6 Bleeding control...6 Access to caries...6 Gingival contouring: Creating a gingival trough...6 Gingival contouring: Removing redundant tissue...7 Gingival contouring: Aesthetic contouring...7 4. Technical Information PerFect TCS II Electrosurge...7 General...7 Classification...7 Electrical...7 Transport and storage conditions...7 Operational ambient conditions...7 5. Special Notes and Precaution Maintenance and service...7 Sterilizing electrode sheaths...8 Cleaning unit and handpiece cord...8 Electrosurge Analyzer...8 Anesthesia...9 Control of odor and viral plume...9 Contraindications...9 Product markings... 10 Accessories... 10 6. Electromagnetic Compatibility EMC Guidance and Declarations... 12 Bibliography... 16 7. Figures Figure 1 – Figure 8... 192 Figure 9 – Figure 14... 193

The PerFect® TCS II is intended only for use by licensed dental practitioners who have received appropriate training in the application of electrosurgery. This guide is not intended as a substitute for formal instruction. The unit should only be operated in locations where the standard nominal mains voltage is indicated for use with the equipment.

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a licensed healthcare practitioner.

1. Introducing PerFect Tissue Contouring System Few technologies have a potential equal to that of electrosurgery for enhancing the efficiency and improving the results of soft tissue management. With a reasonable investment of time to acquire the necessary skills, electrosurgery can pay considerable dividends to both practitioner and patient. With this in mind, Coltène/Whaledent has developed the PerFect Tissue Contouring System - an advanced, affordable monopolar electrosurge designed to appeal to both the new and experienced user of electrosurgery. PerFect TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva. Refer to Section 3 for a formal statement of intended use. How does monopolar electrosurgery work? Electrosurgery is a proven technology that has been used for many years in both dentistry and medicine. It uses radio-frequency (RF) energy, similar to that used in radio broadcasting, to volatilize, cut and coagulate soft tissue. The radio-frequency energy used by PerFect TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively. The high frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient’s back during use. The dispersive electrode provides an efficient and predictable completion of the energy path. Depending on the intended use, the energy output of an electrosurge may be either partially or fully rectified. A fully rectified output is appropriate for cutting, while coagulation is best achieved with a partially rectified output. For these reasons, PerFect TCS II has two output modes: “Cut” and “Coag.” The intensity of these modes can be adjusted by the operator as required. Cutting with the scalpel crushes and cleaves tissue. Electrosurgical cutting volatilizes tissue in the path of the electrode. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.

PerFect® TCS II Tissue Contouring System See Figures 1 and 2 and follow the steps below to prepare your PerFect TCS II for operation. The unit and accessories are pictured in Figure 3. • Before connecting the unit to the AC power supply, check that the Coag/Cut output intensity control is set at the center (“0”) position and that the power switch is in the “Off” (“O”) position. This product has been manufactured with an IEC 320 power cord inlet connector using a detachable cordset (line cord) to plug in at the rear of the unit. Please be sure to plug the cordset into the inlet connector before the next step. • Plug the line cord plug into a three-wire grounded AC power outlet. • Plug the handpiece cable BNC connector into the handpiece jack on the right side of the unit. • The handpiece holder can be placed on either side of the unit by snapping it into the placement grooves under the side lip of the unit. Once the handpiece holder is attached, it cannot be removed. • This unit performs monopolar electrosurgery. A dispersive electrode must be placed against the patient’s back to provide a safe return path for the high frequency current. • Insert the dispersive electrode cable plug into the dispersive electrode jack on the right side of the unit. • Select one of the three electrode sheaths supplied with the unit (Straight Knife, Long Loop, or Coag Ball). To assemble the handpiece, hold the swivel connector and thread the electrode into the handpiece cord assembly. To disassemble, simply reverse rotations.

To reduce risk of infection, electrode sheaths must be sterilized before each use. WARNING Activating the unit The power switch is located in the rear alongside the IEC 320 power cord inlet connector. With the power switch in the “On” position (“1”) the green power indicator light should be on and all other indicator lights should be off. If the red indicator light is on, the dispersive electrode is not properly connected or is defective and should be replaced. First, rotate the output intensity control to the left (Coag) or right (Cut). Output intensity is increased by moving the control away from center in either direction. It may be necessary to move past the “1” position before an output will be generated. PerFect TCS II is now in the “ready” position. No warm-up time is required for the unit.

2. Preparing PerFect TCS II for use Unpacking and setting up the unit Remove PerFect TCS II from the shipping carton and inspect for possible damage during shipping. Check the serial number of the unit (Figure 2) against the serial number on the shipping carton to make sure they agree (if they don’t agree, contact your dealer). Fill out the warranty card and mail to C oltène/Whaledent within 10 days of receipt.

CAUTION

Do not energize the electrode for more than 10 seconds. Damage to the unit may occur. Wait 30 seconds before each electrode activation to allow cooling time. Not following or non-compliance with this caution will void the manufacturer warranty.

To energize the electrode, depress the footswitch before applying the electrode to tissue. The electrode should only be energized for short, intermittent periods - just long enough to perform the required procedure. The unit should emit a tone while the output is energized. A yellow indicator should be “On” to indicate cut mode or a blue indicator should be “On” to indicate coagulate mode.

Owner’s Guide

NOTE: A warbling sound indicates that the dispersive

electrode is not connected or is defective. In this situation, the unit is automatically deactivated and will not operate. Verify the dispersive electrode connector is fully inserted. If it is, the dispersive electrode may be defective and should be replaced. If the replacement does not correct the situation, the unit requires servicing.

5 1. Insert the Coag Ball electrode and rotate the Output Control to position “1” on the Coag scale (to the left). 2. Activate the electrode and, with a dabbing motion, place the ball tip in light contact with the specimen, maintaining contact for approximately 1 second. Allow 10–15 seconds for the tissue to cool and repeat the procedure until a blanched spot indicates that coagulation is achieved.

When the procedure has been completed, remove the electrode from tissue and deactivate the footswitch. Rotate the intensity control to the center “0” position and unscrew the electrode sheath from the handpiece cord assembly for sterilization.

3. Repeat this technique at successively higher output intensity settings until blanching occurs after one or two applications of the electrode: this is the proper setting for most coagulation procedures.

Please Note: In compliance with IEC 60601-2-2, requirements for the safety of high frequency surgical equipment, this unit generates an audible tone when operated.

4. Also practice coagulating with the Straight Knife electrode, which is particularly useful in hard to reach areas. However, since the Straight Knife electrode focuses energy in a smaller area, the intensity setting should be lower than that used with the Coag Ball electrode.

Preoperative practice This guide is not intended to be a substitute for formal instruction. The new user of electrosurgery is strongly urged to undertake adequate study before performing clinical operative procedures. After receiving instruction, practicing on raw, lean beef can help the practitioner acquire the necessary dexterity to achieve superior clinical results. Select a piece of fresh, lean beef (round steak or shin beef) and allow to reach room temperature. Cutting practice 1. Place the meat on the dispersive electrode. 2. Thread the Straight Knife electrode sheath onto the handpiece swivel connector. 3. With the power switch “On,” rotate the Intensity Control to position “1” in the Cut mode (to the right). 4. Depress the footswitch to activate the electrode. 5. Using a smooth, rapid, brush-like motion, make several incisions of varying length and depth (Figure 4). You may find it helpful to use a finger rest to achieve precise control. Observe that the electrode either fails to cut or does so only with considerable dragging. Note also that cutting, if it occurs, causes tissue shreds to adhere to the electrode tip. 6. Repeat the procedure above at successively higher intensity settings. If the electrode encounters appreciable resistance, the setting is too low. Increase the setting until there is no resistance to cutting and there is no sparking and no discoloration along the incision. This point is the lowest effective intensity setting for a practice procedure. Allow 10–15 seconds for the tissue to cool before cutting again in the same area. 7. Increase the intensity setting one position above that which provided optimum results. Observe sparking and discoloration in the form of charring and tissue blanching along the cutting track. Continue to practice a variety of incisions using different electrodes and with the intensity setting at different levels. Observe the cutting results and the action of the electrode tip when settings are too low, too high, or correct. For best results, use the lowest effective output intensity; this is the proper setting for most procedures. Coagulation practice With a little practice, coagulation is easily achieved with the PerFect TCS II. Use the same specimen of lean beef on the dispersive electrode. Simulation of effective coagulation is achieved when the treated area shows a blanched spot of approximately 2 mm or less in diameter.

General principles of electrosurgery technique The following guidelines will help you benefit from the advantages of electrosurgery. For additional important information, please refer to the Special Notes and Precautions section. Placement of equipment It’s important to place the PerFect TCS II unit so that the controls, handpiece, electrodes, and accessories are readily accessible for use with a minimum of motion and wasted time. The unit should be plugged in at all times and the console should be within arm’s reach of the operator. All of the functions, controls and settings should be controlled by the dentist. The dispersive electrode The dispersive electrode ensures that the energy flow from the small, active electrode is predictable and uniform. It must be used during all electrosurgical procedures. The entire area of the dispersive electrode should be placed in firm, nonconductive contact with the patient, preferably against the patient’s upper back, contacting the maximum possible area. To reduce the risk of accidental RF burns, do not place the dispersive electrode in contact with bare skin. Hand-held or hand-worn dispersive electrodes should not be used.

WARNING

The patient, operator or assistant should not come into contact with metal parts, such as metal arm rests of chairs. Use only non-conducting (plastic) instruments (mirror, retractor, saliva evacuation tube, etc.) when performing procedures.

The cutting stroke Your cutting stroke should be smooth, rapid and brush-like. Before each cut, you may find it helpful to try several practice strokes with an inactive electrode, much as a golfer takes practice strokes before putting. This will help you assume a comfortable grasp on the handpiece and will enable you to plan the position and length of the actual cutting stroke. Remember to use the lowest effective output setting for best results. When cutting, use several short strokes rather than a single long stroke. Rather than commit to a single irreversible cut (as you must do with a scalpel), you may find it preferable to shave tissue in very fine layers to achieve a more precise, aesthetically pleasing result. Cutting precision can also be enhanced by using a finger or hand rest to steady your stroke.

WARNING

If your cutting stroke is too slow or if you leave the electrode too long in one area, a build up of lateral heat may cause necrosis and sloughing of tissue.

TO REDUCE THE RISK OF UNINTENDED TISSUE DAMAGE, ALWAYS BEGIN WITH AS LOW A POWER SETTING AS WILL PROPERLY PERFORM THE PROCEDURE. • To allow heat to dissipate safely, you should always wait 10–15 seconds between cuts in the same area.

WARNING

• After each cutting stroke, deactivate the electrode and wipe it on an alcohol-soaked pad. Charred or carbonized electrodes should not be used; they should be restored by cleaning with alcohol and a very fine emery cloth. • Electrosurgery should only be performed on healthy tissue. • Tissue should be moist, but not wet, in the operative area. • In addition, the electrode should not be activated in a pool of blood.

3. Clinical Guide to PerFect TCS II Indications for use The PerFect TCSII is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity. Bleeding control The improved bleeding control you achieve with PerFect TCS II saves chair time, simplifies procedures and improves patient comfort. Bleeding is virtually absent during electrosurgical procedures because the electrode coagulates as it cuts. If bleeding does occur, coagulation is a relatively simple procedure. 1. Attach the Coag Ball electrode sheath to the handpiece cord assembly (or use the Straight Knife electrode if the area to be coagulated is difficult to reach). 2. Rotate the Output Control to the coagulation output setting you have established from previous experience or during preoperative practice. Remember to use the lowest effective output setting for best results. 3. Rinse and air dry the operative field to visualize the bleeder. 4. Touch the bleeding area intermittently with the electrode (Figures 5 and 6). Duration of contact should be approximately one second, with a 10–15 second pause between contacts. Bleeding cessation indicates a successful coagulation. One or two applications of the electrode are usually sufficient to stop bleeding. 5. Use postoperative dressing if necessary.

PerFect® TCS II Tissue Contouring System Access to caries The benefits of the PerFect TCS II will be readily apparent when it is used to gain access to caries. The PerFect TCS II makes it possible to remove occluding tissue in a matter of seconds and complete restorative procedures immediately. The procedure is usually blood-free and provides a clean, dry and highly visible operative field for the removal of caries and the placement of restorations during one visit. 1. The Long Loop electrode is well suited for obtaining access to most carious lesions. For caries occurring in tight interproximal areas, the Straight Knife may be more appropriate. 2. Explore the extent of the tissue to be removed with a periodontal probe. 3. With the Output Control setting in the cutting mode and at the predetermined output setting, shave off the gingival tissue covering the lesion with a few strokes of the Long Loop electrode (Figure 7). Allow 10–15 seconds for the tissue to cool before cutting again in the same area. 4. With the caries exposed (Figure 8), restorative procedures can begin immediately. Gingival contouring: Creating a gingival trough Gingival troughs are created to provide a space into which a sufficient amount of impression material can flow. You will find PerFect TCS II to be exceptionally useful in this procedure, either as an alternative to a retraction cord or in conjunction with it. For example, you may create a partial trough in an area where the retraction cord does not provide space for a sufficient amount of impression material to flow. Gingival troughs can be made either before or after tooth preparation. If they are made before tooth preparation, visibility and access are improved and margins can be finished readily. When the trough is completed and the tooth is prepared, the impression can be taken immediately. Gingival troughs should not be made in aesthetically critical areas with thin marginal gingiva because of the possible loss of gingival height on healing. 1. When creating a complete gingival trough, use the Long Loop electrode (for shoulderless preparations with a thin gingival mucosa, the Straight Knife electrode may be used). 2. Electrode position is especially important during this procedure: the angle between the electrode and the tooth should be minimal. Too wide an angle may result in a reduced height of the marginal gingiva. Figure 9 shows the proper angle of the Loop electrode in relation to the tooth. If the resulting trough is too narrow, retrace the trough (after waiting 15 seconds) while increasing the electrode angle slightly. 3. Begin troughing on the lingual surface, so the output intensity, stroke speed and cutting depth can be adjusted before operating on the facial surfaces. Do not attempt to create a gingival trough with one continuous sweep around the circumference of the tooth. Instead, the troughing should be performed in four separate, short cutting strokes (Figure 10), each sweeping a quadrant of the gingival sulcus. The following cutting stroke sequence is recommended: (1) the palatal (lingual) surface, (2) the labial (buccal) surface, (3) the mesial surface, and (4) the distal surface. As shown in Figure 10, the last two (shorter) excisions join the first two to create a continuous and uniform gingival trough. Figure 11 shows the immediate postoperative condition of a gingival trough.

Owner’s Guide

Gingival contouring: Removing redundant tissue

Electrical

Prior to impression-taking or cementation of restorations, PerFect TCS II may be used to remove redundant tissue that may interfere with the procedure and help control bleeding.

AC Line Voltage

1. Thread the Long Loop electrode sheath onto the handpiece swivel connector of the handpiece cord assembly.

S8115: 115 VAC, 50/60 Hz, 1.6A S8230CE, S8230UK: 230 VAC, 50/60 Hz, 0.8A S8240: 240 VAC, 50/60 Hz, 0.8A

2. With the electrode loop parallel to the tissue being removed, (Figure 12), slice the tissue off in thin layers until the desired result is obtained.

CUT Maximum Power Output

50 Watts

COAG Maximum Power Output

33 Watts

Remember to allow 10–15 seconds for the tissue to cool before cutting again in the same area.

Output Impedance

600 Ohms

Nominal Operating Frequency

3.68 MHz

Gingival contouring: Aesthetic contouring

Coag Modulation Frequency

120 Hz

PerFect TCS II pays special dividends in tissue contouring for aesthetic purposes. Frequently a minor procedure can greatly enhance the patient’s appearance. With care and practice, it is possible to attain precise control of the amount of tissue removed to ensure superior results, both aesthetically and therapeutically. In addition, the smooth, pressureless cutting stroke reduces the time necessary for most aesthetic contouring procedures. You may use either the Straight Knife or the Long Loop electrode for aesthetic contouring. Shave or “plane” away tissue in successive thin layers until the desired appearance is achieved.

Coag Modulation Waveshape

Square wave

Remember to allow 10–15 seconds for the tissue to cool before cutting again in the same area.

Operational ambient conditions

In Figures 13 and 14, the operator has easily corrected a patient’s crooked smile resulting from a marked asymmetry of the gingival levels of the incisors.

4. Technical Information PerFect TCS II Electrosurge oltène/Whaledent Inc. Catalog Nos. S8230CE, S8230UK, S8240 C and S8115 (Additional suffixes are used to indicate differences in types and quantity of included electrodes.)

Transport and storage conditions +70ºC (+158ºF) -40ºC (-40ºF)

10%

S8230CE Continental European style AC plug with earth contact (IEC 60884-1 CEE7 VII) S8230UK British style three prong AC plug with fuse (BS 1363) S8240 Australian style three prong plug (AS 3112, NZS 198) Classification Electrical: Class I, protective earth conductor utilized in power cord Applied Part: Type BF Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE. <10s Equipment Limitation >30s Intermittent operation maximum: 10s output energized, 30s minimum de-energized. In other words, for continuous repetitive use do not operate for more than 10 seconds followed by a 30 second resting period.

30%

700hPa (10.2 psi)

5. Special Notes and Precaution

Dimensions: 108 x 159 x 222 mm (4 1/8 x 6 1/4 x 8 3/4”) S8115 Flat Blade USA style three prong AC plug (NEMA 5-15P)

1060 hPa (15.4 psi)

Electromagnetic Environment - See section 6

General Weight (unit and attached footswitch): 2.4 kg (5.29 lbs.)

500hPa (7.25 psi)

75%

+35ºC (95ºF) -10ºC (14ºF)

1060 hPa (15.4 psi)

100%

WARNING

To reduce the risk of electric shock, remove AC power by disconnecting line cord before performing any maintenance on the unit.

Maintenance and Service PerFect TCS II has been carefully designed and constructed to ensure reliability and long life. Other than protecting the unit from misuse or damage, minimum maintenance is required. Should your PerFect TCS II fail to perform in accordance with specifications, if any component is dropped or mishandled, or if any evidence of damage is found, the unit should not be used. Return it to your dental dealer or to Coltène/Whaledent for servicing. We urge you to periodically examine your unit and accessories for visible signs of damage or wear. Yearly verification of performance characteristics is recommended. The PerFect TCSII is an electrical appliance requiring proper disposal in accordance with local regulations.

PerFect® TCS II Tissue Contouring System ammoniated solution diluted in accordance with manufacturer’s directions. Remove and rinse thoroughly.

PerFect TCS II Output Power Power (Watts)

3. Sterilize: Package in an FDA cleared or CE marked wrap prior to sterilization. Sterilization can be performed with either of the following cycles: • In a gravity steam sterilizer at 132°C/270° for 15 minutes with a 20 minute drying time. • In a dynamic air removal steam sterilizer at 132°/270° for 4 minutes with a 20 - 30 minute drying time.

Control Setting CUT

• In a dynamic air removal steam sterilizer at 134°C/273°F for 3 minutes with a 20 - 30 minute drying time.

COAG

PerFect TCS II Power Output vs Control Setting

Do not use dry heat, cold sterilization or chemiclave. Make sure the area is dry before assembly.

Power vs. Load per Setting and Mode

1. The handpiece cord assembly may be wiped clean with gauze pads saturated in 70% ethyl alcohol after unplugging from unit. Before use, dry the connector area thoroughly with a dry wipe and by gently blowing air on the connector.

Cleaning unit and handpiece cord

Power (Watts)

60.00

2. The unit may be wiped clean with gauze pads dampened in 70% ethyl alcohol after unplugging the unit. Assure that it is thoroughly dry before use.

50.00 40.00 30.00

3. The dispersive electrode assembly may be wiped clean with gauze pads dampened in 70% ethyl alcohol after unplugging from the unit. Assure that it is thoroughly dry before use.

20.00 10.00 0.00 100

200

500

600

1000

2000

Load Resistance (Ohms)

CUT 3

CUT 6

COAG 3

COAG 6

WARNING PerFect TCS II Power Output vs Load Resistance

Volts Peak

Open Circuit Output Voltage

Electrosurge Analyzer The use of an electrosurgical device analyzer to measure performance of the PerFect TCS II will likely indicate lower than expected output power. The capacitive loading caused by the input circuit of the analyzer will detune the output circuit of the PerFect TCS II electrosurge. Measurement can still be made by making direct connection to the PerFect TCS II at the output BNC connector on the side of the unit rather than using the supplied cable. Eliminating the cable will reduce output capacitance by 250 pF. An additional capacitance will have to be added to bring the total output capacitance (analyzer input circuit plus added capacitor) to 250 pF. Any capacitor added to the output must be rated for at least 1000V.

Control Setting CUT

To reduce the risk of RF burns the following test must be performed by a technician who has been trained in maintenance of electrosurge units.

COAG

PerFect TCS II Unloaded Output Voltage vs Setting WARNING

To reduce the risk of an electric shock: • Do not tamper with the PerFect TCS II or any of its components. • Be certain the PerFect TCS II is plugged into a three-wire grounded power source. Do not use plug adaptors that eliminate ground.

Sterilizing electrode sheaths For safety and optimum performance, sterilize each electrode sheath before initial use and after each subsequent use. 1. Remove all debris from the electrode sheath by scrubbing with brush and soap and water. Do not bend wire. 2. Clean in an ultrasonic cleaner, (such as C oltène/Whaledent’s BioSonic® Ultrasonic Cleaner), with general purpose, non-

WARNING

Interference produced by the operation of the high frequency surgical equipment may adversely influence the operation of other electrical equipment. In case of interference, deenergize or increase distance to susceptible equipment. Connection to a different power circuit may also reduce interference. See section 6 for more information.

Owner’s Guide

• Electrosurgery should not be used within approximately 4.5 meters of persons with active implantables, such as pacemakers, cochlear implants, or nerve stimulators, as functions of these devices may become impaired or permanently damaged. WARNING

• The use of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen should be avoided. Non-flammable agents should be used for cleaning or disinfecting. Solvents of adhesives should be allowed to evaporate before the application of highfrequency electrosurgery. Some material may be ignited by sparks produced in normal use of the equipment (for example, cotton wool and gauze when saturated with oxygen). Endogenous gases may be ignited by electrosurgery.

• To reduce the risk of unintended tissue damage allow a 10 to 15 second cool down period between cuts in the same area for heat to dissipate safely. To reduce the risk of accidental burns, consider the following precautions: • Do not use PerFect TCS II in the presence of flammable anesthetics or explosive gases.

• Regularly inspect the accessories, particularly the electrode sheaths and cables, for possible insulation damage. • The electrode sheaths used with the electrosurgical device have a limited life expectancy and should be replaced after twenty (20) autoclave cycles or sooner, upon the appearance of any signs of wear or erosion.

• Metal conducts radio frequency energy just as it conducts electricity. Remove partial dentures if removable and check the area for fixed partial dentures. Metal restorations can conduct energy beyond the anesthetized area and cause discomfort to the patient.

WARNING

• Take care that metal restorations, bone, or teeth do not come into contact with active electrodes. While fleeting contact will not be detrimental, extended contact may result in damage. All instruments used during electrosurgery should be made of a nonconducting plastic material. Cotton rolls or gauze pads used in the patient’s mouth should be kept moist during electrosurgery. Remember to deactivate the electrode each time the electrode sheath is removed from the operative site and before it is cleaned or changed. Skin-to-skin contact (for example between the arms and body of the patient) should be avoided by insertion of dry gauze for example. • When high frequency surgical equipment and physiological monitoring equipment is used simultaneously on the same patient, all monitoring electrodes should be placed as far as possible from the surgical electrode. Needle monitoring electrodes are not recommended. In all cases, monitoring systems incorporating high frequency, current limiting devices are recommended. • Position cables to the surgical electrodes in such a way that contact with the patient or other leads is avoided. • Store electrodes out of reach of the patient. • Apparent low output or failure to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact at its connections.

WARNING

• Use only accessories supplied by Coltène/ Whaledent intended for use with this equipment. The active electrode and handle is 100% hi-pot tested to 3000 VAC. Peak voltage to the active electrode may reach 450V and must be rated to 675V at 3.68 MHz. The dispersive electrode normally does not receive significant voltage but must be insulated to 4000 VAC. • Failure of HF (high frequency) surgical equipment or excessive electrical interfer ence could result in an unintended power output increase, decrease or activation. In the case of electrical interference, de-energize or increase distance to the equipment causing interference. Connection to a different power circuit may also reduce interference. • Where HF (high frequency) current could flow through a relatively small cross section of the body it may be desirable to use bipolar techniques not available with this equipment.

Anesthesia Local or general anesthesia must be used with all electrosurgical procedures. As with any other surgical device, the patient may experience temporary post-operative pain from the use of electrosurgery after the anesthetic effect has diminished. Control of odor and viral plume Odors and viral plume caused by electrosurgery must be minimized by using a high speed, high volume evacuator between the patient’s mouth and nose. Contraindications Do not use on patients with active implantables. Do not contact metal restorations with the electrode tip.

PerFect® TCS II Tissue Contouring System

Product markings

Atmospheric Pressure Limitation

Type BF Applied part Electric Shock Hazard

Neutral electrode referenced to earth

Biological Risks

Warning

Manufacturer

Foot Switch

European Representative Footswitch cable Accessories

Handpiece

S213 Dispersive Electrode Handpiece connector

S6000CE Complete Handpiece System S6008CE Handpiece Cord Assembly S6010A 8 Sterilizable Electrode Sheaths (1 of each type)

Cut mode

S7001 Handpiece Holder S7010A 3 Sterilizable Electrode Sheaths (1 Straight Knife, 1 Long Loop, 1 Coag Ball)

Coagulate mode

Non-ionizing electromagnetic radiation

<10s >30s

Intermittent operation maximum: 10s output energized, 30s minimum de-energized

European Directive 2002/96/EC (Waste Electrical and Electronic Equipment WEEE)

Temperature Limitation

Humidity Limitation

Owner’s Guide

S6011A Coag Ball (2) S6011A S6011A S6011A S6011A S6011A S6011A S6011A

S6012A 45° Straight Knife (2) S6012A S6012A S6012A S6012A S6012A S6012A S6012A

S6013A 45° Tapered Knife (2) S6013A S6013A S6013A S6013A S6013A S6013A S6013A

S6014A Straight Round Loop (2) S6014A S6014A S6014A S6014A S6014A S6014A S6014A

S6015A 45° Long Loop (2) S6015A S6015A S6015A S6015A S6015A S6015A S6015A

S6016A S6016A S6016A S6016A

S6016A Straight Long Loop (2)

S6016A S6016A S6016A

S6017A S6017A S6017A S6017A

S6017A 45° Diamond Loop (2)

S6017A S6017A S6017A

S6018A S6018A S6018A S6018A S6018A S6018A S6018A

S6018A 90° AP 1 1/2 (2)

PerFect® TCS II Tissue Contouring System

6. Electromagnetic Compatibility The following are guidance and manufacturer’s declarations regarding electromagnetic compatibility for the Perfect® TCSII. 1.1 EN/IEC 60601-1-2 Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Perfect® TCSII is intended for use in the electromagnetic environment specified below. The customer or the end user of the Perfect® TCSII should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment guidance

RF emissions CISPR 11:2004

Group 1

The Perfect® TCSII must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Specifically the Perfect® TCSII intentionally emits RF energy at 3.68 MHz to perform its intended use. It must comply with Group 1 emissions when switched ‘on’ with the RF output inactive.

RF emissions CISPR 11:2004

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/Flicker emissions IEC 61000-3-3

Complies

The Perfect® TCSII unit is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purposes, provided the following warning is heeded: Warning: This equipment is intended for use by healthcare professionals only. This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures such as re-orienting or relocating the Perfect® TCSII unit or shielding the location.

Owner’s Guide

1.2 EN/IEC 60601-1-2 Table 2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Perfect® TCSII unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the Perfect® TCSII unit should assure it is used only in such an environment. Immunity Test

IEC60601 test level

Compliance Level

Intended Electromagnetic Environment

Electromagnetic discharge (ESD) IEC 61000-4-2

+- 6kV contact +- 8kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/ +-2kV for power supply lines burst +-1kV for input/output lines IEC 61000-4-4

+-2kV for power supply lines +-1kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

+-1kV differential mode (line-line) +-2kV common mode (line-earth)

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Perfect® TCSII unit requires continued operation during power mains interruptions, it is recommended that the Perfect® TCSII unit be powered from an uninterruptible power supply with sufficient capacity to run the unit for the maximum required time of interruption.

3A/m

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

Note UT is the a.c. mains voltage prior to application of the test level.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

PerFect® TCS II Tissue Contouring System

1.3 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 4: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Perfect® TCSII unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the Perfect® TCSII unit should assure it is used in such an environment. Immunity Test

IEC60601 test level

Compliance Level

Intended Electromagnetic Environment Portable and mobile RF communications equipment should be used no closer to any part of the Perfect® TCSII unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80MHz to 800 MHz

Conducted RF IEC 61000-4-6

3Vrms 150kHz to 80MHz

Radiated RF IEC 61000-4-3

3V/m 80MHz to 2.5GHz

d = 2.3√P 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended minimum separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from objects, structures and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Perfect® TCSII unit is used exceeds the applicable RF compliance level above, the Perfect® TCSII unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re‑orienting or relocating the Perfect® TCSII unit.

Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Owner’s Guide

1.4 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 6: Recommended separation distances between portable and mobile RF communications equipment and the Perfect® TCSII unit The Perfect® TCSII unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Perfect® TCSII unit can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and the Perfect® TCSII unit as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter in watts (W)

Separation distance according to frequency of transmitter in meters (m) 150kHz to 80MHz d = 1.2√P

80MHz to 800MHz d = 1.2√P

800MHz to 2.5GHz d = 2.3√P

0.01

.12

.23

0.1

.38

.73

1.0

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Bibliography 1.

Azzi R et al: The effect of electrosurgery on alveolar bone. J. Periodontal 54(2):96-100, February 1983.

Bouchier G et al. Round table: Electrosurgery in daily practice. Rev Odontostomatol (Paris) 12(6):432-440, November/December 1983.

Clark JW: Use of electrosurgery in restorative and related dental procedures. Oral Health 73(8):63-71, August 1983.

Conroy CW: Electrosurgery as an aid in periodontal procedures for the general practitioner. NYS Dental Journal 50(6):352-353, June/July 1984.

Feinberg E: Electronic surgery for improved esthetics. Dental Clin North Am 26(4):891-898, October 1982.

Goldstein AA: Radiosurgery in dentistry. Oral Health 68(11):32-39, November 1978.

Kalkwarf KL: Epithelial and connective tissue healing following electrosurgical incisions in human gingiva. J Oral Maxillofac Surg 41(2):80-85, February 1983.

Kalkwarf KL: Lateral heat production secondary to electrosurgical incisions. Oral Surg 55(4):344-348, April 1983.

Kalkwarf KL: Subjacent heat production during tissue excision with electrosurgery. J Oral Maxillofac Surg 41(10):653-657.

10. Kelly WJ Jr et al: Electrosurgery in restorative dentistry. NYS Dental Journal 50(6):345-347, June/July 1984. 11. Miotti M et al: Comparative study on the healing of intra-oral surgical wounds and on the formation of postoperative edema. G Stomatol Ortognatodonzia 2(1):39-40 (Engl Abstr) January/ March 1983. 12. Oringer MJ: ColorAtlas of Oral Electrosurgery (Chicago, Il., Quintessance Books, 1984). 13. Pezzoli M et al: Technics of gingival retraction: a comparative study. Iiíiv Ital Stomatol 51(2):147-153, 1982. 14. Pipko DJ: Preclinical exercises in electrosurgical techniques. Dent Clin North Am 26(4):693-697, October 1982. 15. Pollack BF: Understanding dental electrosurgery. NYS Dental Journal 50(6):340-341, June/July 1984. 16. Poster A: Efficient placement and usage of dental electrosurgical equipment. NYS Dental Journal 50(6):342-343, June/July 1984. 17. Schon F: Electrosurgery In the Dental Practice (Berlin and Chicago, Die Quintessance Publishers, 1974). 18. Schon F: Threatened intra- and post-operative bleeding. Scalpel or electrome? ZWR (Ger) 91(9):28-31, September 1982. 19. Strong D et al: Esthetics enhanced with electrosurgery. Dent Clin North Am 26(4):781-798, October 1982. 20. Tillis BP: Electrosurgery: A valuable Alternative. NYS Dental Journal 50(6):323, June/July 1984. 21. Trice WB: Electrosurgery, the universal modality in dental practice. CDS Rev 76(5):38-40, June 1983.

PerFect® TCS II Tissue Contouring System

Benutzerhandbuch

Literaturverzeichnis 1.