XO ODONTOSURGE Instruction Manual

LIST OF CONTENTS Page A. Component Parts – XO ODONTOSURGE ... 2 B. Odontosurge Features ... 4 B1. High Frequency ... 4 B2. Ergonomics ... 4 C. Set-up ... 5 C1. Handpiece and Cord ... 5 C2. Handpiece holder ... 5 C3. Control Box ... 5 D. Operation Controls ... 6 D1. Mode Switch Panel ... 6 D2. ON/OFF Finger Switch ... 6 E. How to Operate ... 7 F. Preparation and Familiarization ... 9 F1. Dissection Exercise ... 9 F2. Coagulation Exercise ... 9 F3. General Advice ... 9 G. Clinical Application ... 11 G1. Contraindications to HF Soft Tissue Surgery ... 11 H. Cleaning and Sterilization ... 12 H1. The Instruments. ... 12 H2. Handpiece and Cord ... 12 H3. Control Box ... 12 I.

Accessories ... 13

J. Maintenance and Safety ... 13 K. Technical Specifications ... 14 L. Warranty ... 15 M. Important Notes and Warnings ... 16

A.

COMPONENT PARTS - XO ODONTOSURGE

1.

Instrument socket

5.

Handpiece holder

2.

ON/OFF finger switch for instrument activation

6.

Mode switch panel

3.

Handpiece, detachable

7.

Seven instruments in holder casing

4.

Handpiece cord

8.

Control box

2

9.

Mains power cord

10. green lamp

11.

13.

Handpiece cord connector

15. Mains power inlet

14.

Warning symbol - see chapter M

16. Main ON/OFF switch

3

blue lamp “COAG”

12.

yellow lamp “CUT”

17. Fuse drawer

B.

XO ODONTOSURGE FEATURES

B1. High Frequency The XO ODONTOSURGE operates at a frequency of 27 Megahertz (MHz) which is about ten times higher than conventional Soft Tissue Surgery units. This exceptionally high operating frequency results in multiple advantages - operationally as well as functionally. 1. At the high frequency, the entire surface of the patient’s body is acting as a large passive or neutral electrode which, via the air, returns the high frequency signal. As a result the conventional and cumbersome passive or patient electrode which also increases patient apprehension, is rendered obsolete by the XO ODONTOSURGE. 2. The high operating frequency is far from frequencies that are able to stimulate nerve tissues. As a result the profound anaesthesia required with conventional low frequency units is not necessary. It is however recommended that in most cases, some level of anaesthesia be used for patient comfort. 3. The high frequency plays a central role for the completely automatic and instantly responding power tuning system of the XO ODONTOSURGE. As a result the unique power tuning system is continuously controlling and precisely adapting the power output from a cutting instrument. The instrument delivers the exact amount of energy to make a perfect incision, irrespective of varying clinical conditions. If a cutting instrument nears bone or tooth structures, the tuning system immediately reduces the power to avoid thermal bone tissue necrosis. B2. Ergonomics Operator compatibility and ease of use coincide with XO ODONTOSURGE’s unique use of High Frequency and automatic power tuning. The passive patient electrode as well as current waveform selection switches and power adjustment switches, found on conventional units are rendered obsolete by the XO ODONTOSURGE. As well, there is no need for the conventional foot switch, as the ON/OFF activation control is contained in the handpiece. Furthermore, the XO ODONTOSURGE is easily portable between operatories, and its sleek and clutter-free design makes it unlikely to arouse patient apprehension as is often the case with conventional units.

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C.

SET-UP

Your XO ODONTOSURGE comes complete with control box, handpiece and cord, casing including a selection of 7 different instruments, and a mains power cord. C1.

Handpiece and Cord

1. Connect the handpiece with the matching connector at the end of the handpiece cord. 2. Connect the opposite end of the handpiece cord with the matching connector at the rear of the control box. 3. Clip the handpiece in place by pressing it laterally into the handpiece holder. C2.

Handpiece holder

1. Attach the handpiece holder by inserting its tongue into the slot in the side of the control box (left or right side at option). C3.

Control Box

1. Check that your unit is correctly rated for your local power line supply voltage (see rear of the control box). 2. Connect the power cord with the matching power inlet on the rear of the Control box, and plug into a wall socket with appropriate protective ground connection. NOTE!

Should your unit not be equipped with the appropriate power cord (i.e. pins different from your local standard) contact your dealer and/or authorized service engineer.

3. Your unit is now ready to be switched ON by pushing the main ON/OFF switch on the rear of the control box.

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D.

OPERATION CONTROLS

D1.

Mode Switch Panel

The green lamp turns on as soon as the unit is switched ON by means of the main ON/OFF switch at the rear of the control box.

Finger touch-switches: COAG-switch: Turns blue lamp on and off. - Blue lamp ON means coagulation mode (COAG-mode) with handpiece ready to operate. - Blue lamp OFF means standby mode (ST.BY-mode) with handpiece inoperative. CUT-switch: Turns yellow lamp on and off. - Yellow lamp ON means cutting mode (CUT-mode) with handpiece ready to operate. - Yellow lamp OFF means standby mode (ST.BY-mode) with handpiece inoperative.

D2.

ON/OFF Finger Switch

ON:

Press and hold the rubber ring between fingers (acoustic signal).

OFF:

As soon as released.

NOTE!

The finger switch is only operative in the active modes i.e. in the CUT mode or in the COAG mode. 6

E.

HOW TO OPERATE

On switching the XO ODONTOSURGE unit ON, the mode switch panel will automatically go to the standby mode (only green lamp on). Cutting (dissection): 1. As a first step, always make sure that the unit is in the standby mode (only green lamp on). If necessary, touch switches to turn blue and yellow lamps off. 2. Insert the desired cutting instrument (wire instrument) fully and firmly into the handpiece. 3. Touch the CUT-switch to turn the yellow lamp on. CUT- mode. 4. The instrument is now ready for operation. Activate the instrument by pressing and holding the ON/OFF finger switch on the handpiece. Note the acoustic signal for cutting. Coagulation (haemostasis): 1. As a first step, always make sure that the unit is in the standby mode (only green lamp on). If necessary, touch switches to turn blue and yellow lamps off. 2. Insert the desired coagulation instrument (ball or rod instrument) fully and firmly into the handpiece. 3. Touch the COAG-switch to turn the blue lamp on. COAG-mode. 4. The instrument is now ready for operation. Activate the instrument by pressing and holding the ON/OFF finger switch on the handpiece. Note the acoustic signal for coagulation.

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IMPORTANT! Do not start clinical work until having carefully studied Chapter F: ”Preparation and Familiarization”. CAUTION:

Any treatment must be initiated by checking that the ON/OFF finger switch responds with an acoustic signal. Do not touch the instrument, when the acoustic signal is sounding.

CAUTION:

Always switch to standby-mode (only green lamp on) as soon as the treatment has been completed and also during any pause in an ongoing treatment.

CAUTION:

Always switch to standby-mode (only green lamp on) before inserting or removing an instrument.

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F.

PREPARATION AND FAMILIARIZATION

When taking the XO ODONTOSURGE into use for the first time, it is strongly recommended that the operator gets familiar with the XO ODONTOSURGE by practising before starting to work under clinical conditions. This can be done with a piece of fresh and lean meat which, when held in the operator’s hand, constitutes an acceptable clinical model. F1.

Dissection Exercise

1. Select the standby mode by touching switches to turn blue and yellow lamps off. 2. Insert a straight needle wire instrument. 3. Touch the CUT-switch to turn yellow lamp on, and check that the ON/OFF finger switch responds with an acoustic signal. 4. Place the meat in the palm of one hand on a piece of paper towel. The meat should not be dry. If it is, moisten lightly with water. 5. Hold the handpiece in a pencil-type grip and hold the instrument in position slightly above the tissue surface. Activate the instrument by pressing and holding the ON/OFF finger switch. You will hear the acoustic signal for the CUT-mode. 6. Make an incision a few millimetres deep in the meat by advancing the instrument in a single continuous stroke, while using the high speed suction for odor evacuation. 7. Practise making shallow and deep incisions - also incisions of varying depth. While making the incisions, the instrument should always be kept in motion and be moved as rapidly as the tissue resistance permits. Next, practise tissue sculpting or ”electroplaning” using the wire loop instrument, and ”troughing” with a wire hook instrument. You will observe that the shape of the instrument, and the angle of the instrument to the tissue surface will determine the shape of the cut.

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F2.

Coagulation Exercise

The COAG mode is used with the ball instrument provided to control isolated areas of bleeding. 1. Select the standby -mode by touching switches to turn blue and yellow lamps off. 2. Insert the ball instrument fully into the handpiece and touch the COAG switch to turn blue lamp on. Check that the ON/OFF finger switch responds with an acoustic signal. 3. Hold the instrument in position slightly above the meat tissue surface and activate the instrument by pressing and holding the ON/OFF finger switch. The acoustic signal for the COAG mode will now be heard. 4. Make repeated taps with the activated instrument on the tissue. This will result in small ”target” areas of coagulation which will effectively stop spot bleeding in a clinical situation. F3.

General Advice • Always activate the instrument (acoustic signal) prior to making contact with the tissue. • Always keep the instrument clean and free of tissue remnants. • Always keep a cutting instrument in motion in a steady, continuous stroke. • Always keep a coagulating ball instrument in motion in a tapping movement. • Always keep the tissue moistened. Spray with sterile water, when necessary

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G.

CLINICAL APPLICATIONS

The XO ODONTOSURGE is intended to cut or remove soft tissue or to control bleeding during surgical procedures, in particular in the oral cavity. With the correct use in the proper clinical situation, HF Soft Tissue Handling with the XO ODONTOSURGE will become an invaluable tool in all phases of Dentistry. All disciplines, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and of course, routine restorative dentistry will greatly benefit from your use of the XO ODONTOSURGE. Special instructions are available upon request. G1.

Contraindications to HF Soft Tissue Handling:

1. HF Soft Tissue Handling is contraindicated in patients with cardiac pacemakers. 2. HF Soft Tissue Handling should not be used in proximity to flammable anaesthetic gases and oxygen. 3. Medical consultation should always be considered prior to using HF Soft Tissue Handling in those patients who may be systemically medically compromised, especially those with abnormal healing processes such as diabetes, blood dyscrasias, collagen disturbances, and patients undergoing irradiation treatment.

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H.

CLEANING AND STERILIZATION

H1.

The Instruments

A prerequisite of clean and well-defined incisions is clean instruments. Fair-sized tissue remnants can be removed by wiping - REMEMBER to switch back to standby mode (only green lamp on) before touching the instrument. Otherwise clean by immersion into a 3% hydrogen peroxide solution and subsequent wiping. IMPORTANT! Always handle the instrument wires with care in order to avoid deformation and breakage. The recommended infection control procedure is to autoclave the instruments between patients. The instruments can be sterilized by steam autoclaving (maximum temperature 135°C/ 271° F), conveniently when placed in the holder casing with opened or removed cover. H2.

Handpiece and Cord

The handpiece and cord should be cleaned by wiping with alcohol based or soap water based disinfectant solutions. The recommended infection control procedure is to autoclave the handpiece between patients. The handpiece, handpiece cord and handpiece holder can be sterilized by steam autoclaving (maximum temperature 135° C/250° F). H3.

Control Box

Clean and disinfect only by wiping with an alcohol sponge or with non-aggressive surface disinfectants. Cannot be autoclaved.

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I.

ACCESSORIES

Ref. No.: 225129 225127 220097

Description: Handpiece Handpiece cord with connectors Holder casing with seven instruments

220501 220504 220510 220511 220513 220514 220515

Instruments Type Shank needle straight loop straight ball straight needle straight needle angled needle angled loop straight

Tip part straight wire, thin circular wire, diam. 5 mm ball, diam. 3 mm straight wire, heavy angled wire, heavy angled wire, thin circular wire, diam. 10 mm

Additional, more special instruments are available. Request separate information.

J.

MAINTENANCE AND SAFETY

Please observe the following instructions at all times: - The XO ODONTOSURGE must be installed and operated in accordance with this Manual. - The XO ODONTOSURGE and its accessories must not be taken into use, if signs of operational, electrical or mechanical defects are found. - The XO ODONTOSURGE must not be taken into use, if heavy sparking between instrument and tissue is observed. - The control box must not be exposed to excessively high or low temperatures and extreme moisture. - The XO ODONTOSURGE is engineered to meet the general safety requirements of EN 60601-1 (IEC 601-1) and particular requirements of EN 60601-2-2 (IEC 601-22). - Technical changes including repairs, adjustments/calibrations and modifications may only be made by XO CARE A/S or specialists approved by XO CARE A/S. - Do not attempt to open the control box or to disassemble the handpiece. - The XO ODONTOSURGE should be submitted to your dealer or to XO CARE A/S for general service check-up at least every two years. 13

K.

TECHNICAL SPECIFICATIONS

Product name:

XO ODONTOSURGE

Mains connection:

1-phase with protective earthing

Mains voltage:

100/115/230V, 50/60 Hz (see rating label)

Classification:

Class 1, type CF (IEC 601-1) Class IIb (M.D.D. 93/42/EEC)

Primary fuses: (time-lag)

For mains voltage 100 and 115V: 2.00 amp For mains voltage 230V: 0.80 amp

Generator frequency:

27 MHz

Max. output power:

50 watts at non-inductive load impedance of 500 ohms

Max. power consumption:

190 VA (voltamps.)

Manufacturer:

XO CARE A/S Usserød Mølle, Håndværkersvinget 6, DK-2970 Hørsholm, Denmark Tel.: Fax:

+45 7020 55 11 +45 7020 5510

E-mail: [email protected] www.xo-care.com

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L.

WARRANTY

For the XO ODONTOSURGE, XO CARE A/S grants a warranty of 12 months as from the date of the Contract of Sale and in accordance with terms and conditions defined on the Guarantee Card going with each unit. Defects proven to be caused by failure of materials, construction or manufacturing will be repaired free of charge. Any further liability is explicitly declined. The warranty does not apply to normal wear or to damage resulting from accident, abnormal use, misuse, abuse or neglect. Guarantee repairs or replacements will only be carried out upon receipt of the defect unit together with its Guarantee Card. Responsibility as to the safety, reliability and performance of the XO ODONTOSURGE will not be accepted by XO CARE A/S: a. If the equipment has not been used under normal conditions for its intended purposes and in strict accordance with this manual and/or b. if any technical changes including repairs, adjustments/calibrations and reconstructions have been made by anyone other than XO CARE A/S or specialists approved by XO CARE A/S. The purchaser assumes all risks and liabilities resulting from the use of the XO ODONTOSURGE, whether used separately or in combination with other products not manufactured by XO CARE A/S. XO CARE A/S continually strives to improve its products and therefor reserves the right to improve, modify or discontinue products at any time, and to change the specifications without notice and without incurring obligations.

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M.

IMPORTANT NOTES AND WARNINGS

1. Use of electrosurgical devices can cause electromagnetic interference in other insufficiently immune devices. CAUTION: Do not use the XO ODONTOSURGE on patients with im planted cardiac pacemaker. CAUTION: Use of the XO ODONTOSURGE may interfere with other unshielded electromedical equipment. 2. The risk for igniting flammable gases or other materials is inherent in Soft Tissue Surgery and cannot be eliminated by device design. CAUTION: Precautions must be taken to avoid contact of flammable materials and substances with electrosurgical instruments, whether they are in the form of an anesthetic or skin preparation agent, are produced by natural processes within body cavities, or originate in surgical drapes, tracheal tubes or other materials. 3. The warning symbol

at the handpiece cord connector on the control box denotes

as follows: Rated max. power output:

50 watts at non-inductive load impedance of 500 ohms.

Operating frequency:

27.126 MHz.

CAUTION: For the sake of operator safety, instruments should only be inserted/ removed from the handpiece when the mode setting is in standby – only green lamp on. CAUTION: An instrument in the handpiece must not be touched when the acoustic signal is sounding. NOTE!

Any operation should be initiated by checking that the ON/OFF finger switch on the handpiece responds by an acoustic signal.

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4. The Medical Device Vigilance System imposes on manufacturers the duty to promptly report to Competent Authorities in case a medical device made by the manufacturer has caused an incident that led to a serious deterioriation of the state of health of a patient or user. In the improbable event that your XO ODONTOSURGE should be involved in such an incident, it is therefore very important that you: 1. Promptly inform XO CARE A/S, 2. immediately stop using the unit, and 3. immediately store the unit separately and exactly in the condition it was in, i.e. without any kind of cleaning or disassembling.

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