XO CARE A/S Usserd Mlle Hndvrkersvinget 6 DK-2970 Hrsholm Denmarktel +45 70 20 55 11 fax +45 70 20 55 10 www.xo-care.com

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XO ODONTOGAINSYSTEM TM

Instruction Manual

Introduction

The XO ODONTOGAIN SYSTEM includes the XO ODONTOGAIN TM

ultrasonic scaler and the XO PERIODINE TM

antimicrobial irrigation solution.

The intended use of the XO ODONTOGAIN SYSTEM is - in particular - subgingival scalingand debridement (periodontology) withXO PERIODINE used as irrigant.

However, the XO ODONTOGAIN scaler is also highly effective for ultrasonic scaling(prophylaxis) in general with a variety of other irrigants.

The XO ODONTOGAIN SYSTEM is intended for professional use by qualified and trainedoperators.

The XO ODONTOGAIN scaler is intended for use as an independent unit without the needfor connection or combination with other devices.

We kindly ask and recommend that you take the time to carefully study this manual in orderto familiarize yourself with the XO ODONTOGAIN SYSTEM.

By following our instructions and recommendations, you and your patients will appreciateand benefit from the advanced technology and ergonomics that have been invested intothe XO ODONTOGAIN SYSTEM based on decades of experience.

In case of problems or questions, please feel free to contact our service staff or yourdealer.

XO CARE A/S

List of contents

A. The XO PERIODINE..............................................................................2

B. The XO ODONTOGAIN scaler..............................................................5

B1. Illustrations......................................................................................6

B2. Set-up and preparation.................................................................8

B3. Operation and use........................................................................14

B4. Maintenance, cleaning and sterilization.....................................15

B5. Service and repair........................................................................17

B6. Accessories..................................................................................18

B7. Technical specifications...............................................................19

C. Important notes and cautions................................................................20

A. The XO PERIODINE

The XO ODONTOGAIN SYSTEM - Use of XO PERIODINE

What is XO PERIODINEXO PERIODINE consists of a iodofor named Povidone-Iodine (PVP-I), which is a solutionof iodine in a polymeric called polyvinylpyrrolidone (povidone). In order to produce PVP-I,povidone, ordinary iodine and water must be heated until a bond of hydrogen betweenPVP and iodine is established. The XO PERIODINE is ready for use and contains 0.1% offree iodine. Since the sixties PVP-I has been used in hospitals and in agriculture for disin-fection purposes. No allergic reactions to the solution have been observed due to the com-plex bond to povidone. However, it is not advisable to use the solution on patients,who are allergic to iodine, on pregnant and breast-feeding women, and on patientswith hypotyroidism. The only local side effect is temporary yellow stained teeth and mu-cosa. The former can be removed by cleaning with pumice. The discoloration of mucosawill disappear in the course of one day. There are no documented side effects such as latewound healing or resistant bacteria.

When and on which patients is XO PERIODINE usedXO PERIODINE is advisable to use as an initial treatment and on patients with untreatablemarginal periodontitis and patients who, for some reason, are not having surgical treat-ment. Studies have shown that treatment with PVP-I has proved advantageous to patientswith pocket depths of more than 6 mm. Furthermore, treatment of furcation involvement isindicated. Recent studies also show that the long-term effect of treatment with PVP-I onpatients who primarily receive either non-surgical treatment (traditional scaling and oral hy-giene control) or are treated with mucogingival surgery is the same.

How to use XO PERIODINEXO PERIODINE is used as part of the XO ODONTOGAIN SYSTEM. This treatment systemconsists of the XO ODONTOGAIN ultrasonic scaler and XO PERIODINE, which is a furtherdevelopment of the Odontoson as all known features of it are included in the XOODONTOGAIN. Furthermore, XO ODONTOGAIN is designed so that is can dose XOPERIODINE as cool flushing and bactericidal media instead of ordinary water. See how touse XO PERIODINE later on in this manual. Studies have proved that a treatment of a fullmouth patient must take at least one hour and that approx. 1 litre of XO PERIODINE isneeded for the treatment. As a positive side effect of PVP-I, the number of bacteria in theaerosol is reduced, and it also seems to show that the risk of transient bacteriaemia is re-duced.

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Which documentation is available on the use ofXO ODONTOGAIN SYSTEMA large number of studies has proved that PVP-I has a great bactericidal effect. The mostwell documented studies were made on the Gothenburg University by a team headed bythe Senior Lecturer Odont.Dr. Bengt Rosling. Some of the studies have a follow-up periodof 12 years. The following conclusions can be made of the scientific results mentioned be-low.

XO ODONTOGAIN ultrasonic scaler with waterA three month oral hygien programme consisting of instruction in hygiene and subgingivalscaling with XO ODONTOGAIN ultrasonic scaler maintained the bone and attachment levelconstantly during a 12 year period on 80% of the persons in the experiment, which were allin a high-risk group - the criteria more than 8 teeth with more than 6 mm attachment loss(PAL). However, on 20% of the persons in the experiment the progression continued inspite of the above treatment. In another test group with normal risk - the criteria only 10%of the patients must have more than 6 mm attachment loss (PAL) - the above treatmentproved successful to more than 95% of the persons, as the treatment resulted in totalprophylaxis. Only about 3% of the patients showed continued progression.

On patients with advanced periodontal disease, the surgical treatment proved more effec-tive than the non surgical treatment with regard to eliminating the pocket depth (PPD). Thenumber of surgically treated patients who for a period of 1-3 years after the treatmentshowed signs of advanced disease progression was smaller than that of the non surgicalgroup (12% as compared to 25%). On most patients in both groups it was possible tomaintain periodontal conditions for a period of 12 years with only a few cases ofregression and moderate loss of attachment measured by PAL. All non surgical treat-ment was made with Odontoson - the predecessor of XO ODONTOGAIN.

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XO ODONTOGAIN ultrasonic scaler with XO PERIODINEIn an experiment carried out by Dr. Rosling and his staff, 223 patients with advanced de-structive periodontitis were involved according to the following criteria - minimum 8 nonmolars with PPD larger than or equal to 6 mm on 2 or more teeth in each quadrant and withradiological loss of attachment of more than 40% on the same teeth.On baseline I the oral hygiene, gingivitis, PPD, PAL and RxBL were examined. After thebaseline the patients were divided into two groups, two persons out of three in a controlgroup and one in a test group. Non surgical treatment was made with Odontoson and 0,1%PVP-Iodine. All participants were summoned for comparing examination after 3, 6 and 12months (baseline II) and then after 3, 5 and 13 years, in the period of which they receivedoral hygiene treatment every 3 months. After 3 years 73 patients had left for ethical, physi-cal or other reasons. The results showed that non surgical treatment results in improvedgingival conditions with reduced PPD and gain in PAL. It was also proved that local use ofa 0,1% PVP-Iodine solution together with the use of Odontoson had even better results, asthe values of the PPD and PAL were significantly better in the test group. Finally, their workshowed that over a period of 12 months with hygiene follow-up every 3 months it was pos-sible for the patients to avoid progressions.

Literatture on XO PERIODINE Greenstein G: Povidone-Iodines effects and role in the management of periodontal dis-

eases: A review. J Periodontol 1999; 70: 1397-1405 Rosling B, Hellstrm M-K, Ramberg P, Socransky SS, Lindhe J: The use of PVP-Iodine

as an adjunct to non-surgical treatment of chronic periodontitis. J Clin Periodontol2001; 28: in press

Serino G: Outcome of treatment in subjects with different severity of periodontal dis-ease. Thesis. Department of periodontology, Faculty of Odontology, Gteborg Univer-sity, Gteborg 2001 Slots J, Jorgensen MG: Efficient antimicrobial treatment inperiodontal maintenance care. JADA; 131: 1293-1304

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B. The XO ODONTOGAIN scaler

Your XO ODONTOGAIN is a multi-purpose dental scaler for periodontology, endodonticsand prophylaxis. A high degree of freedom as to your choice of irrigation liquid has been amain objective.

Particularly interesting is the possibility of subgingival scaling with XO PERIODINE as anantimicrobial irrigation solution. However, a variety of other irrigation liquids can be usedat your own choice, including sterile irrigation liquids.

The XO ODONTOGAIN even gives you the possibility of having two different irrigation liq-uids at hand during the treatment, and it is easy to switch between the two liquid sourcesjust by operating a finger touch pad.

The integrated peristaltic roller pump system does not make any direct contact with the liq-uid to be pumped. With an appropriately sterilized irrigation line and by using appropriatesterile handling procedures, it is therefore possible to transfer liquid from a sterile liquidsource to the treatment site without affecting the sterility.

In this connection the pre-sterilized disposable irrigation tubing kits of all XOODONTOGAIN are highly effective together with the autoclavable handpiece and hand-piece cord.

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B1. Illustrations

1. XO PERIODINE 8. Power cord

2. Spear 9. Instrument insert

3. Bag hanger 10. Handpiece

4. Vessel support 11. Tubing kit

5. Control box

6. Handpiece cord

7. Handpiece holder

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18. Connector socket 20. Main ON/OFF 22. Power inletfoot control I/O

19. Pinch valve 21. Fuse drawerirrigation selection

12. Touch pad 14. Touch pad 16. Touch padpower setting irrigation flow rate irrigation selection

13. Indicator lamps 15. Indicator lamps 17. Connectorhandpiece cord

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B2. Set-up and preparation

B2.1 The control box

1. Insert the power cord (8) into the power inlet socket (22) at the rear of the control box(5) , and insert the cord plug into a plug outlet with protective grounding. Can bepowered with any line voltage be tween 100 and 240 volts without further measures.

2. Connect the handpiece cord with the connector (17) on the front ofthe control box.

3. Attach the handpiece holder (7) by inserting its tongue into the slot in the side of thecontrol box (left or right side at option).

B2.2 Handpiece and instrument insert

1. Connect the handpiece (10) with the connector socket at the end of the handpiececord (6),

2. Snap the instrument insert (9) into the open end of the handpiece.

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B2.3 The irrigation line

The XO ODONTOGAIN is delivered with irrigation tubing kits in pre-sterilized packages.The kits are for one time use only. Do not re-sterilize.

Caution: The tubing kits have been sterilized by radiation.Sterility cannot be relied upon 1) if the package hasbeen opened or damaged, and 2) after the expirationdate stamped on the package.

The tubing kit is designed for transferring irrigation liquid from liquid sources to the irriga-tion inlet on the handpiece cord - see illustrationbelow.

Tubing kit

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Attaching tubing kit

1. Stretch first valve part into inner valve slot.

2. Repeat to insert second valve part into outer valve slot.

3. Insert pump part into first holder. 4. Stretch pump part over pump wheel.

5. Insert pump part while stretched into second holder.

6. Connect outlet end with irrigation inlet on handpiece cord.

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Tubing kit as attached

Note! For sterile operation it is of course necessary to observeappropriate sterile handling procedures during the attach-ment of the tubing kit.

Detaching tubing kit

Detaching after use of the tubing kit takes place in the reverse order. However to releasethe valve part from the inner valve slot it is necessary to push the black button on the freeend of the pinch valve.

Push black button while detaching from inner valve slot.

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Irrigation liquid sources

The XO ODONTOGAIN is designed for operation with two liquid sources at hand for use atyour choice.

1. Insert the stem of the vessel support (4) into one of the socketholes (23) in the top of the control box.

2. Unscrew the screw cap on the XO PERIODINE bottle, place the bottle on thesupport and penetrate the alu-seal with the spear (2).

3. Cut off the bag cannula on one branch of the tubing kit and connect the open tubingend thus provided with the connector stub on the spear (2).

4. The second tubing branch can be used in the same manner to arrange a second,alternative liquid source.

5. Switching between the two liquid sources takes place by operating the finger touchpad (16). The indicator lamp to the left of the touch pad (16) indicates that the tubingvalve part in the inner valve slot is open for operation.

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Alternative liquid sources

The bag hanger can be inserted into either of the two socket holes (23) for suspension of asealed bag or bottle.

In case of a glass bottle, the green vent flap on the cannula should be opened to allowadmission of filtered air into the bottle during its emptying.

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B3. Operation

The control box is turned on and off by operating the I/O main switch (20) at the rear. Whenturned on ( Switch position I ) at least one of the indicator lamps (13) at the front of the controlbox will be illuminated.

B3.1 Instrument start/ stop.

With the control box turned on, the tip vibrations and liquid spray of an instrument insert in thehandpiece can be started and stopped by operating the switch ring at the front end of thehandpiece (Vibration off - push switch ring forward).

As an alternative, the start/stop operation can be made by a foot control (to be ordered sepa-rately) connected to the connector socket (18) at the rearof the control box.

B3.2 Power setting (Vibration amplitude).

The amplitude or output power of the tip vibration can be adjusted by operating the circularfinger touch pad (12) on the front of the control box. The lamps (13) at the front indicate (yel-low light) the actual setting.

B3.3 Spray Intensity

The intensity or quantity of liquid sprayed from an operating instrument tip can be adjusted byoperating the touch pad (14).

1. Touch the pad (14) until the lamps (13) change to green light.2. Adjust the liquid spray by operating the pad (14). The lamps (13) (green light)

indicate the actual setting.3. The lamps (13) automatically go back to yellow light, if untouched for a period of

a few seconds.

B3.4 Exhange of instrument inserts

The handpiece is designed to accept quick-change interchangeable instrument inserts.

1. Pull the instrument collar to snap out an instrument insert.2. Shake the handpiece to empty off liquid, if any.3. Snap in another instrument insert with a clockwise turning motion. Make certain that

it is fully seated in the handpiece.

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B4. Maintenance, cleaning and sterilization

B4.1 The instrument inserts

The shape of the instrument tip is vital to the effciency of the rotating tip and the ultrasoniceffect.

Do not attempt to sharpen, bend or otherwisere-shape the instrument tips!.

It is important that the instrument is always firmly seated in the handpiece and the ferriterod is properly tightend to the tip.

Regularly - and especially in the case of instrument malfunction - check and tighten theferrite rod to the tip. (Use the clamp wrench and steel pin provided to change and tightenferrite rods).

The instrument tip will be worn during use. At the end of the lifetime of the tip the lamps(13) will start flashing, thereby indicating that it is time for instrument replacement.

B4.2 The Ferrite rod

You can easily exchange the ferrite rod yourself - if broken or otherwise damaged. Use thespecial service kit - see illustration.

NOTE! When you mount a new ferrite rod, it is important that it is firmly and correctlytightened to the tip part.

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Otherwise the high frequency vibrations generated in the rod will not be properly trans-ferred to the instrument tip. This would cause poor tip vibrations and reduced lifetime forthe instrument insert.

B4.3 Cleaning and sterilization

A. Instrument inserts:

Can be cleaned and sterilised using all clinically acceptable methods (max.180C/350F).

B. Handpiece and handpiece cord:

Do not soak in liquid. Clean only by wiping with alcohol based or soap wa-ter based disinfectant solutions.

Do not use any disinfecting or cleaning products containing aggressivechemicals. Do not soak in ultrasonic cleaners with ultrasonic cleaning so-lutions, nor place the handpiece in soaking basins with liquid chemicals.

Sterilize only by steam autoclaving at a maximum temperature of 133C/271F.

C. Control box:

Clean by wiping with alcohol based or soap water based disinfectant solu-tions.

D. Irrigation line:

Do not re-sterilize the tubing kit.

After use always carefully flush the entire device to eliminate all PVP-Iodine.Jodine may cause severe corrosion of the XO ODONTOGAIN instrument when leftinside during several hours. Just place the cannula or spear in a container withclean water and let the unit operate for one or two minutes.

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B5. Service and Repair

Do not attempt to open the control box or to disassemble the handpiece.

Service and repair may only be made by approved specialists. Return the equipment to thedistributor in the original packing.

Responsibillity as to the safety, reliability and preformance of the equipment will not beaccepted by the Manufacturer or Distrubutor if:

a) the equipment has not been used in strict accordance with thismanual and/or

b) any technical changes including repairs, adjustments/calibrations and/orreconstructions have been made by anyone other than the Manufacturer orspecialists approved by the Manufacturer.

It is recommended that the equipment be returned to the distrubutor/manufacturer for serv-ice check-up at least every second year.

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B6. Accessories

Supplementary kits (to be ordered separately)

A. Sterile kit including:- 100 disposable tubing kits (extra length)- coupling piece for insertion between handpiece and cord.

B. Foot control kit including:- on/off foot control with cord and connector.

C. Retro kit including:- 2 retro instrument inserts for making retrograde root fillings.

D. Service kit including:- 2 ferrite rods- clamp wrench for exchange of ferrite rod- 5 steel pins for exchange of ferrite rod

E. Special instrument inserts:Request separate information.

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B7. Technical Specifications:

Product name: XO ODONTOGAIN

Mains Connection:

Type: Single phase with protective groundingMains voltage: 100 to 240 Vac (at option)Mains frequency: 50/60 HzPrimary Fuses: T315 mA 250 V

Classification: Class 1, type B (IEC 601-1)Class IIa (Directive 93/42/EEC)

Max. power consumption: 45 VA

Manufacturer: XO CARE A/SHndvrkersvinget 6P.O. Box 380DK-2970 HrsholmDenmark

tel. +45 70 20 55 11fax. +45 70 20 55 10e-mail. sales@xo-care.comwww.xo-care.com

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C. Important notes and cautions

1. Always use the XO ODONTOGAIN SYSTEM for its intended purpose only.XO CARE A/S accepts no liability for damage or injury caused directly orindirectly by improper use.

2. Always clean and sterilize new or repaired handpieces and instrument insertsbefore first use.

3. Always avoid contact with porcelain crowns, veneers and composite resinrestorations.

4. Avoid touching the patients lips, tongue or mucosa with the uncooled partof the instrument tip.

5. Never use the instrument inserts without ample supply of irrigation.

6. Do not attempt to sharpen, bend or otherwise re-shape the instrument tips.

7. In rare cases the instrument tip may fracture, in particular if damaged orimproperly handled.

8. Avoid any spillage of XO PERIODINE. May stain.

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