SENSIMATIC 700SE ELETROSURGE Instructions for Use Rev E April 2022

Warnings • DO NOT OPEN CASE: NO USER SERVICEABLE PARTS INSIDE.

evaporate before the use of 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.

• Internal repairs are to be made only by Parkell personnel. To avoid the risk of electric shock, this equipment must only be connected to a properly grounded electrical outlet.

• The unit should not be immersed in water or other liquids. Avoid placing where it can fall or be pulled into liquid. Do not reach for the device if it has fallen into liquid. Do not use the device after it has fallen into liquid. Return it to Parkell for servicing.

• Always exert caution during use. Electrosurgery units are designed to allow controlled destruction of soft tissue and must be used carefully. • Do not use in any situation where the electrode will touch metal restorations, implants, bone or teeth as this may result in electric shock, bone necrosis or implant rejection.

• Do not open the case of the unit-there are no user serviceable parts inside. • Do not modify this device. Modification may violate safety codes and endanger patient and operator. Any modification will void the warranty.

• Stop use immediately at the first sign of tissue blanching and avoid prolonged tissue contact. Allow tissue to cool for an appropriate interval between cuts. Excessive exposure may retard healing and cause sloughing.

• Interference produced by the operation of high frequency surgical equipment may adversely influence the operation of other electrical equipment. In case of interference, de-energize unit and increase distance to susceptible equipment. Connection to a different power circuit may also reduce interference.

• Do not use in the presence of flammable or explosive gases. Use of dental nitrous oxide/oxygen analgesia is acceptable. Solvents of adhesives should be allowed to

Clinical Precautions

Conformance to Standards

• Caution: Do not operate the electrosurgery unit without using the patient indifferent pad. The pad should not touch the patient’s bare skin, but should always have a thin layer of clothing between it and the skin.

The Sensimatic 700SE Electrosurge is ETL listed and conforms to IEC 60601-1, 60601-1-2 and 60601-2-2. Parkell’s quality system is certified to ISO13485. Certified to CAN/CSA C22.2 No. 601.1.

What’s Included

• Caution: Always turn power off before touching the electrode. After locking the electrode in the handpiece, examine it carefully to assure that the metal shaft is fully seated with no metal exposed at the base.

• (1) Sensimatic 700SE power unit • (6) Different Electrodes; Scalpel Point-T2, Large Loop-T5, Vertical Loop-T8, Horizontal Loop-T16, Hemostasis Ball-C3, Troughing Point-AP1.5

• Caution: Be sure the handpiece, cable and electrodes are completely dry before using. Inspect the handpiece and cables regularly to ensure their integrity.

• (1) Foot switch • (1) Handpiece and cable • (2) Self-stick handpiece holding clips

• Caution: Before each use, inspect the electrode to assure that the plastic sheathing (insulation) covering the metal shaft is intact. Do not bend the electrode where it is insulated, as this may crack the plastic sheath.

• (1) Indifferent Plate and Cable • (1) AC Power Cord • Operator’s Manual / Instructions for Use

• Caution: Release footswitch before inserting or removing the handpiece from the patient’s mouth. • Caution: Do not allow cables to be coiled or twisted around metal objects. 2

Specifications

50

POWER OUTPUT IN WATT (+/-20%)

• Power Requirements: Line Voltage: 120 Volts +⁄- 10% AC, 60 Hz, 2 amps maximum • Optional: 100 Volts +/- 10% AC, 50/60 Hz, 2 Amps maximum, 230 Volts +⁄- 10%, 50/60 Hz, 1.2 amps maximum • Fuses: T2.5AH, 250 V, 5x20mm (Both line and neutral fused)

45

25 20 15 10 5

1KΩ

2KΩ

100Ω

200Ω

CUT-COAG

500Ω

1KΩ

2KΩ

500Ω

100Ω

200Ω

1KΩ

2KΩ

100Ω

200Ω

CUT

COAG

POWER AT HALF & FULL OUTPUT CONTROL SETTINGS OVER THE RANGE OF NON-INDUCTIVE LOAD RESISTANCE OF 100Ω,200Ω, 500Ω, 1KΩ & 2KΩ

• Maximum Output Voltage (no load): 300 Volts rms

POWER OUTPUT AT ALL CONTROL SETTINGS AT 500Ω NON-INDUCTIVE LOAD RESISTANCE 50

POWER OUTPUT IN WATT (+/-20%)

• Unit Size: 3 ¼” H x 7 ¾” D x 9 ¼” W (83mm x 191mm x 235mm)

500Ω

0

• Maximum Power Output: 50 Watts rms (@ 500 Ohm load) approximate

• Transport and Storage Conditions: 10-43°C, 10-90%rh non-condensing, 500-1060hPa)

Half Output Control Setting

30

• Operating Frequency: 1.4 -1.7 MHz (megahertz)

• Operating Environmental Conditions: 10-35°C, 30-75%rh, 700-1060hPa

Full Output Control Setting

40 35

45 40

CUT

35

CUT-COAG

30 25

COAG

20 15 10 5 0 1

2

3

4

5

6

7

8

9

10

OUTPUT CONTROL SETTING

• Weight: 6.1 pounds (2.8 kg)

• The attachment plug is used as the mains disconnecting device.

High-Frequency (RF) Output Modes The Sensimatic generates three different high frequency waveforms. Each has differing surgical characteristics, which cause different histological effects on soft tissue. • RF Mode No. 1 – “CUT MODE” (cutting with least coagulation): A filtered, unmodulated current for cutting with the least amount of coagulation. Suited for closed wound surgery where incisions will be sutured. • RF Mode No. 2 – “CUT/COAG MODE” (cutting with balanced coagulation): A fully rectified, modulated, undamped current for cutting with coagulation when control of bleeding is desired. It is the most widely employed current in dentistry and is suited for cutting procedures where incisions will not be sutured. • RF Mode No. 3 – “COAG MODE” (full coagulation without cutting): A partially-rectified current for coagulation without cutting. This waveform has been found most effective for precise pin-point surface coagulation with minimal tissue destruction. 3

Fully rectified, fully filtered.

Fully rectified, unfiltered.

Partially rectified, unfiltered.

Get the Most Out of Your New Parkell Electrosurgical Device

sive electrode should be placed in firm, nonconductive contact with the patient, preferably against the patient’s upper back, contacting the maximum possible area. Do not place the indifferent plate in contact with bare skin. Do not attach the indifferent plate to metal frame of chair. 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.

If this is your first electrosurgery device, we’ve got a few simple tips to improve the treatment outcome, protect your warranty, and assure that your unit runs right for a long time. • A lways use the indifferent electrode plate provided with the unit to assure that the least amount of power is required for the procedure being performed. Lower power means less tissue trauma, less post-operative pain and shorter healing times for the patient.

4. Make sure the unit is turned off before touching or changing electrodes. Select the appropriate electrode for the procedure and make sure the metal electrode is clean, and that the plastic sheathing (insulation) is in good condition. Insert electrode into surgical handpiece, making sure it is fully seated with no metal shaft exposed. Turn the collar of the handpiece until electrode is locked in place.

• Fully insert clean, tissue-free electrodes into the handpiece to assure that they transmit all power directly to the patient. Replace electrodes when necessary to maintain performance. • Electrosurgery is best performed on moist (but not wet) gingival tissues. Dry tissues will cause the electrode to drag, and will require higher power to cut properly.

5. Push the AC rocker switch on the rear of the unit to the ON position. Turn the mode selector knob on the front panel from OFF to the chosen operating wave form and the power output knob to select the power for the case at hand. The appropriate indicator LEDs will light to show that the unit is on. Always verify settings before using.

• Proceed slowly and carefully. Remember, you can always remove more tissue, but you can’t add tissue if you remove too much. • Work under adequate anesthesia whenever using the electrosurgery device. • Use high volume evacuation to control burnt tissue odor, and low volume evacuation to manage irrigating fluid accumulation in your patient’s throat.

OPERATING THE UNIT: 1. Always verify power settings before use. a. Use the lowest possible power setting for the procedure at hand. Once the power is set, the 700SE’s power output is adjusted automatically by the unit in response to the tissue condition at the operative site. This eliminates the need for repeated minor power adjustments.

• PARKELL’S ELECTROSURGERY DEVICES SHOULD NOT BE ALTERED BY THE USER IN ANY WAY. FOR EXAMPLE, NEVER CUT OR REMOVE THE COMPANY-INSTALLED FOOTPEDAL CORD, TO SHORTEN OR LENGTHEN IT. UNAUTHORIZED CHANGES TO THE UNIT WILL INSTANTLY VOID YOUR WARRANTY.

b. For coagulation with ball electrodes, an appropriate initial power setting is “3” (Fig. 1). Coagulation is related to the length of time the electrode is in contact with the tissue, the size of the electrode, the circular or spotting motion used during tissue contact and the power level. Whitish blanching at the site indicates coagulation has occurred.

If you need a special cord length, or if you have any questions about your new unit, please E-mail our Technical Support Service at: [email protected].

Instructions for Use

c. For incisions using needle-type electrodes, an appropriate initial power setting is “4” (Fig. 2).

CONNECTING THE UNIT: 1. Locate the device where it will be convenient. Make sure the AC power rocker switch in the rear of the unit is in the OFF position before connecting the power cord. Plug power cord into the back of unit and then plug the power plug into a grounded electrical outlet. NEVER OPERATE THE UNIT W ITHOUT COMPLETE AND PROPER GROUNDING.

d. For excisions using small loop-type electrodes, an appropriate initial power setting is “5”. (Fig. 3) e. When using larger loop electrodes, an appropriate initial power setting is “6”.  or fulguration (carbonization of tissue), use f. F mode #1. An appropriate initial power setting is “8”.

2. Plug the patient indifferent plate and surgical handpiece into the matching color-coded sockets on the front panel.

g. If a clean electrode drags during cutting, or if hemostasis does not occur during coagulation, increase the power to the next higher setting until desired therapeutic results are achieved.

3. The patient indifferent plate must be used for all dental procedures. The entire area of the disper4

Fig. 1

Fig. 2

Fig. 3

• Before each use, make sure the plastic insulation sheathing covering the electrode is completely intact. Replace the electrode if damaged. Check the integrity of the handpiece and cable at this time as well.

2. Good hand support and finger rests are necessary before tissue is contacted. To activate the handpiece, assure that the electrode is safely positioned within the surgical field and depress the foot pedal. When the handpiece is active, the green RF indicator LED will light and an audio tone will sound.

• Make sure the electrode is fully seated in the handpiece (with no metal shaft exposed) and is locked in the handpiece.

3. Tissues being operated upon should ALWAYS be slightly moist to dissipate heat and maintain conductivity. However, excess moisture will lessen effectiveness and may cause patient discomfort. The right moisture balance makes for the best treatment.

•D  O NOT BEND THE METAL SHAFT OF THE ELECTRODE, as you may damage the plastic insulation sheathing. If you want to alter the shape of the bare metal cutting portion of the electrode, do so only before its first use by bending the cutting wire at the end of the electrode away from the start of the insulation, using the appropriate orthodontic plier, to avoid nicking or breaking the wire.

4. Local anesthesia is indicated for all electrosurgical treatment. 5. To avoid minor shocks, use only non-conducting (plastic) instruments (mirror/retractor,

• Electrodes must be kept spotlessly clean. Dirty electrodes will impair their function, and cause unnecessary tissue damage. Between uses, wipe electrodes clean with an alcohol-moistened pad to remove charred tissue.

6. Saliva evacuation tube, etc.) when performing electrosurgical procedures.  perate with the electrode tip as perpendicular 7. O as possible to the plane of surgical intervention. Keep the electrode in constant, controlled, uninterrupted motion. Cut with a light, smooth, even stroke. Avoid electrode penetrations of more than 1mm in depth. For deep incisions, make repeated shallow penetrations with a back and forth, wiping stroke, and allow approximately 10 seconds between incisions for the tissue to cool.

• W hile electrodes may be autoclaved several times, they are a consumable item, and are meant to be periodically replaced. They are not covered by the warranty.

Odor Control Clinical use of electrosurgery generates fumes from the tissues being treated, which will create unpleasant odors in the operatory. This should be explained in advance to the patient. Use of high volume oral evacuation equipment by the dental assistant during surgery will remove most of the odor. Air fresheners sprayed in the room prior to surgery will also help to minimize odors. You may also find it helpful to apply a small dab of mentholated petrolatum ointment (e.g. Vicks® VapoRub®) on the upper lip of the patient to mask odors.

8. P  eriodically wipe carbonized tissue tags from the electrode with an alcohol-moistened wipe, making sure to de-energize the unit first by removing your foot from the foot pedal. The electrode must be clean to maximize the precision of the incision. 9. F  amiliarize yourself with the use of the Sensimatic 700SE Electrosurge by practicing on a fresh piece of moist, lean beef or pork at room temperature. Cover the indifferent plate with a plastic bag and place the meat directly on top of it. Work in a well ventilated area to avoid breathing the cutting fumes.

Common Clinical Problems and Their Causes ■ Excessive elimination of tissue or

Important Information About Electrodes

excessive thinning of a gingival collar. • I mproper electrode selection (e.g. using a wide loop electrode on the labial surface of lower anterior teeth where a straight needle electrode is indicated). • Power set too high. • Poor surgical technique or case selection.

• A LWAYS TURN THE POWER UNIT OFF BEFORE TOUCHING OR CHANGING ELECTRODES, AND KEEP YOUR FOOT OFF THE FOOT PEDAL DURING THIS PROCEDURE. 5

■ Dragging electrode action (even at the

• DO NOT USE DRY HEAT OR CHEMCLAVE ON THE HANDPIECE AND ELECTRODES.

recommended dial setting). • Dirty electrode.

Service and Parts

• Excessively dry field.

Within the U.S., all repairs must be made by Parkell. Outside the U.S., repairs must be made by a Parkell-authorized facility.

• Too deep tissue penetration (more than 2mm). • Failure to use the indifferent plate. • Inadequate contact between the patient and indifferent plate (sometimes due to extra thick clothing).

Complete service and parts facility exists at Parkell, Inc., 300 Executive Drive, Edgewood, NY 11717. Equipment needing service should be returned, freight pre-paid via United Parcel Service and insured for original purchase price. Include unit with all accessories, except electrodes. Ship in original carton. Add plenty of cushioning material and overbox to protect your unit during shipping.

• Impediment at site of contact. • Power set too low.

■ Retarded healing or tissue sloughing. • Power set too high. • Dirty electrode.

REPLACEMENT PARTS

• Electrode penetration too deep.

• Electrode Handpiece with cable ( hD702)

• Electrode movement not controlled well by operator (e.g. motion too slow, erratic electrode motion, staying too long in one spot, picking or pecking at tissue). Use a constant, controlled, even motion.

• Patient Indifferent Plate with cable ( hD703) • Patient Indifferent Plate ( hD634) • Interchangeable Dental Electrodes (See page 7. Not shown at actual size).

• Poor moisture control-operative site must be moist, but not too wet.

Recommended Electrodes for Specific Applications

• Poor surgical technique or case selection.

• Access to Subgingival Caries-Provides a clean, dry restorative field; #T2, #T8, #T16.

Cleaning and Infection Control • Rinse the Handpiece and Electrodes under warm running water for 30 seconds to remove any external or internal soil or debris.

• Cementing Restorations-For more retentive cementation; #T5, #T8, #T16. • Bleeding Control and Coagulation-For a cleaner operative field; #C3, #P4.

• Using a soft soapy cleaning brush to assist in the cleaning, if necessary. Use non-ammoniated detergent or dishwashing soap. Do not use ammoniated cleansers or disinfectants.

• Widening Gingival Sulcus-Provides space for impression material beyond prep margin; #AP 1.5, #P4.

• Rinse the item again under warm running water for 30 seconds to remove any residual soap and blot dry with a dry lint-free towel.

• Lengthen Clinical Crowns-To create a workable clinical crown length; #T2, #T8, #T16.

• Wipe device with a lint-free towel that has been saturated in an EPA-approved, hospital-grade intermediate or high-level disinfectant (minimum 2.5% Glutaraldehyde solution), following the instructions for use provided by the disinfectant manufacturer.

• Esthetic Tissue Contouring-For a more esthetic appearance; #T2, #T8, #T16. • R econtour Edentulous Ridges-To make impression taking more accurate and comfortable, or for the preparation of ovate pontic sites; #T2, T5, #T8, #T16, #P4.

• Dry with a dry lint-free towel.

• Removal of Hyperplastic and Hypertrophic Tissue-Ideal in case of medication-induced gingival hyperplasia; #T2, #T5, #T8, #T16, #P4.

• Handpiece and Electrodes may be sterilized in any conventional steam autoclave following manufacturer’s instructions. A typical steam sterilization cycle is 132 +/- 2°C for 4 minutes (Vacuum). or 132 +/- 2°C for 15 minutes (Gravity), followed by a 15-minute minimum cool-down period.

• Pericoronitis-To expose partially-erupted third molars; #T5, #T8, #T16. • Performing Gingivectomy or Gingivoplasty; #T2, #T5, #T8, #T16, #P4.

• Use a steam sterilization pouch that is compliant with ISO 1140-1 Type 4 and 11607 standards. Once items are sterilized, adhere to the shelf-life specified by the pouch manufacturer. After sterilization, inspect the device in the autoclave bag for integrity. If suspicion about the item exists, discard it and order a replacement from Parkell or your dealer.

• Frenectomy-Relieve excess muscle tension and tissue pull and improve esthetics; #T2. • Exposing Teeth with Delayed Eruption- Allow orthodontic eruption to proceed; #T2, #T5, #T8, #T16. 6

A

B

D

E

C

Electrodes: A. AP1.5 – Troughing Point ( hS397-AP1.5) F

B. T16 – Horizontal Loop ( hS397-T16)

G

C. T5 – Large Tissue Shaving Loop ( hS397-T05) D. T8 – Vertical Loop ( hS397-T08) E. T2 – Scalpel Point ( hS397-T02) F. C3 – Hemostasis Ball ( hS397-C03) G. P4 – Proximal Hemostasis Tip ( hS397-P04). Sold separately, not included with unit.

• Per forming Tissue Biopsy- Controlled removal of suspect lesions with minimal tissue damage; #T2, #T5.

• Exposing Pre-Placement Implant Sites- For fast exposure of the implant placement site; #T2, #T8, #T16. IMPORTANT: AVOID CONTACT WITH THE BONE.

• Exposing Pre-Placement Implant Sites- For fast exposure of the implant placement site; #T2, #T8, #T16. IMPORTANT: AVOID CONTACT WITH THE BONE.

• Periodontal Flaps- Controlled, sharp incisions for better healing; #T2. • Controlling Bleeding of Nicked Gingival Papillae- For accurate impressions after crown preparation; #P4.

• Periodontal Flaps- Controlled, sharp incisions for better healing; #T2. • Controlling Bleeding of Nicked Gingival Papillae- For accurate impressions after crown preparation; #P4.

• Reshaping of Gingival Sulcus into Healthy U-shape- After crown preparation; #P4.

Warranty and Terms of Use

• Reshaping of Gingival Sulcus into Healthy U-shape-After crown preparation; #P4.

For full Warranty and Terms of Use information, please see www.parkell.com. Parkell’s Quality System is certified to ISO 13485.

• Pericoronitis- To expose partially-erupted third molars;#T5, #T8, #T16.

Electrodes are meant to be periodically replaced and as such are not covered by the warranty.

• Performing Gingivectomy or Gingivoplasty; #T2, #T5, #T8, #T16, #P4. • Frenectomy-Relieve excess muscle tension and tissue pull and improve esthetics; #T2. • Exposing Teeth with Delayed Eruption- Allow orthodontic eruption to proceed; #T2, #T5, #T8, #T16. • Per forming Tissue Biopsy- Controlled removal of suspect lesions with minimal tissue damage; #T2, #T5. 7

Explanation of Symbols Used Qualified User Symbol Serial Number

Catalogue / stock number Sterilizable in a steam sterilizer (autoclave) at the temperature specified Non-Sterile

Temperature limitations

Do not use if package is damaged

Follow instructions for use

Keep dry Do not dispose this product into the ordinary municipal waste or garbage system Package contents

Manufacturer

Referenced to ground at high frequencies

Protective Earth Connection

Type BF Equipment

Dangerous high voltage

This precision dental device was designed, manufactured and is serviced in the United States of America by:

300 Executive Drive, Edgewood, NY 11717 Toll-Free: (800) 243-7446 • Phone: (631) 249-1134 • www.parkell.com

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