Tigon Ultrasonic Piezo Scaler Unit Instructions for Use

Contents Symbols...3 – 5 1. Introduction...6 – 7 2. Electromagnetic compatibility (EMC)... 8 3. Unpacking... 9 4. Equipment supplied ...10 5. Safety notes... 11 – 15 6. Description of front panel / rear panel... 16 –17 7. Starting operation – General...18 8. Tip insertion / removal... 19 – 20 9. Switching Tigon on / off... 21 10. Control unit operation... 22 – 24 11. Test run... 25 12. Error messages...26 – 27 13. Hygiene and maintenance... 28 – 36 14. Replacing the O-rings... 37 15. Replacing the pump cartridge... 38 – 39 16. W&H accessories and spare parts... 40 – 41 17. Servicing...42 18. Technical data...43 – 44 19. Disposal... 45 Explanation of warranty terms...46 Authorized W&H service partners... 47 2

Symbols in the Instructions for use

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

Thermo washer disinfectable

Sterilizable up to the stated temperature

Suitable for the ultrasonic bath

Call customer service

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Symbols on the Tigon Follow Instructions for Use Consult instructions for use

Article number Serial number

Class II equipment

Do not dispose of with domestic waste

V

Supply voltage of the unit

Date of manufacture

Foot switch

AC

Alternating current

Electric fuse

Earth

W

Electric power consumption of the unit

Not suitable for intracardiac application – Type B applied part

XXXX

Data Matrix code for product information including UDI (Unique Device Identification)

CE mark with identification number of the Notified Body

A MEDICAL – GENERAL MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND Hz MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1:2006, CAN/CSA-C22.2 No.601.1-M90:2005, CAN/CSA-C22.2 No.60601-1:2008, ANSI/AAMI ES 60601-1:2005 25UX (Control No.)

Supply current Frequency of the alternating current

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Symbols on the packaging XXXX

CE mark with identification number of the Notified Body

Data Matrix code for product information including UDI (Unique Device Identification)

This way up

Data structure in accordance with Health Industry Bar Code

Fragile, handle with care

Temperature limit

Keep away from rain

Humidity limitation

»Der Grüne Punkt« (The Green Dot) trademark of Duales System Deutschland GmbH

Caution: Federal law restricts this device to sale by or on the order of a dentist, physician or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of the device

Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard

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1. Introduction For your safety and the safety of your patients These instructions explain how to use your product. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to us. It is therefore essential that you observe the safety notes on pages 11 – 15. Intended use Drive unit with a piezo-ceramic oscillation system, which sets the scaler tip in linear vibration. The drive unit is used to remove supragingival plaque and subgingival concretions, as well as for endodontic applications and for preparing dental enamel. Misuse can damage the Tigon and hence cause risks and hazards for patients, users and third parties. Qualified use Tigon is only intended for qualified use in dental medicine according to the applicable health and safety regulations, accident prevention measures and in observance of these instructions for use. Tigon must only be prepared and maintained by persons who have been instructed in infection protection, self-protection and patient safety. Improper use (e.g. due to lack of hygiene or maintenance), non-compliance with our instructions or the use of accessories and spare parts not approved by W&H invalidates all claims under warranty or other claims.

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Introduction Qualifications of the user Tigon has been developed and designed for the target group »dentists, dental hygienists, dental employees (prophylaxis) and dental assistants«. Production according to EU Directive The medical device complies with the regulations of Directive 93/42/EEC.

Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of Tigon when there is compliance with the following directions: > Tigon must be used in accordance with these instructions for use. > Tigon has no components which can be repaired by the user. Assembly, modifications or repairs must only be undertaken by an authorized W&H service partner (see page 47). > The electrical installation at the premises must comply with the regulations of IEC 60364-7-710 (“Installation of electrical equipment in rooms used for medical purposes”) or with the regulations applicable in your country. > Unauthorised opening of the equipment invalidates all claims under warranty and any other claims.

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2. Electromagnetic compatibility (EMC) Notes on electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions with regards to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts. The use of other accessories/other spare parts can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference. You can find the current EMC manufacturer’s declaration on our website at http://wh.com or, alternatively, you can also request a copy directly from the manufacturer.

HF communication equipment Do not use any portable and mobile HF communication equipment (e.g. mobile telephones) during operation. These may affect medical electrical equipment.

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3. Unpacking  Lift out insert with stand and foot control.

 Lift out the control unit.

 Remove the carton with the accessories according to the equipment supplied.

W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging.

 Remove the carton with the coolant tank.

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4. Equipment supplied After unpacking, you should have the following parts: REF 13923000  Control unit (230 V) (incl. 1.8 m supply hose with coupling, tray, handpiece support and coolant tank) REF 06270600  Handpiece PB-3 LED REF 05547600  Tip set: Tip changer with universal tip 1U, 3U and periodontal tip 1P inserted REF 05851800  C-NF foot control REF 04717300  Nozzle cleaner REF 00636901  O-ring for hose coupling REF 02060203 (2 pcs)  O-ring for coolant tank REF 05417700 (1 pc)  Tip card  Mains cable REF 01343700 (EU) or: REF 02821400 (USA, CAN, J) / REF 03212700 (UK, IRL) / REF 02909300 (AUS, NZ) / REF 04280600 (CH) / REF 05901800 (DK) alternatively: REF 13923001  Control unit (115 V), (incl. 1.8 m supply tube with coupling, tray, handpiece support and coolant tank) REF 06479400

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5. Safety notes Inappropriate use Improper use, in addition to incorrect assembly, installation, modification or repairs of Tigon or non-compliance with our instructions invalidates all claims under warranty and any other claims The control unit is designed for use with the W&H handpiece PB-3 LED so only this is to be used with the control unit. The use of other handpieces could lead to a deviation or destruction of the electronics. Mains cable Only use the mains cable supplied. Only connect to a grounded socket outlet. Set up the device so that the power switch is easily accessible. In dangerous situations, the device can be disconnected from the power supply using the power switch or power cable. The power switch can also be used to safely stop the device. Control unit The control unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water). System failure A total system failure of Tigon does not constitute a critical fault. Simply switch the unit off and then on again. 11

Safety notes Intermittent operating mode S3 (8 min operating time / 5 min pause time) The permissible relative load time is 8 minutes to 5 minutes pause time. If the operating mode specified is observed no overheating of the system and therefore no injury to the patient, user or third persons arises. The responsibility for the use and timely shutdown of the system lies with the user. Danger zones M and G In accordance with IEC 60601-1/ANSI/AAMI ES 60601-1, Tigon is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide. Tigon is not suitable for use in oxygen-enriched atmospheres. Zone M, also referred to as the “medical environment”, includes the part of a room in which potentially explosive atmospheres may occur as a result of the use of analgesics or medical skin cleaning or disinfectants, but only in small quantities and only for a short time. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle. Zone G, also referred to as an “enclosed medical gas system”, comprises not necessarily fully enclosed cavities in which permanent or temporary potentially explosive mixtures may be generated, supplied or used in small quantities.

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Safety notes This medical device complies with the reference values defined in EN 50527-2-1/2011 for unipolar and bipolar pacemakers and is therefore suitable for patients with pacemakers. > Keep a safe distance of at least 30 cm between the control unit and your patients during operation. > Before using Tigon for the first time, store it at room temperature for 24 hours. > Tigon is not suitable for surgical treatment. > Tigon is not designed to administer drugs or similar substances. > Rinse the supply hose through once a day (rinsing function page 24). > Never fill or top up the coolant tank with liquids hotter than 30 °C. > Only use coolants and rinsing liquids approved by the manufacturer. Approved coolants and rinsing liquids > Sodium chloride (table salt) NaCl > Hydrogen peroxide (H2O2) (1 – 3 %) > Water > Liquids with the active substance chlorhexidine 0.2% Applied parts (parts that come into contact with the patient) > Handpiece, tips, supply hose

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Safety notes > Always ensure correct operating conditions and that sufficient and adequate cooling is delivered. > Always provide sufficient coolant and ensure the appropriate suction (except in endodontic applications). > Turn off the handpiece immediately in the event of failure in the coolant supply (max. operating time without coolant is 30 seconds). Exception for endodontic applications: here use is without coolant (max. operating time 2 minutes). > Provide sufficient space for unrestricted operation of the foot control. > Sterilize the handpiece, the tips and the accessories before using for the first time. > Check Tigon, the handpiece and the supply hose for damage and loose parts (e.g. tip, LED, O-ring) every time before using. Correct any faults or contact an authorized W&H service partner (see page 47). Do not operate Tigon if it is damaged. > Observe the LED test each time Tigon is restarted. Only 1 LED may fail. If more than one LED fails, do not put Tigon into operation. Contact an authorized W&H service partner (see page 47). > Check the parameter settings every time the device is restarted. > Perform a test run prior to each treatment. > Avoid eye contact with the optic outlet. > Never touch the patient and the connection for the foot control simultaneously. > Switch the Tigon off after every application.

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Safety notes > Only replace the LED socket when the handpiece is at rest. > Replace faulty or leaky O-rings in the hose coupling immediately. > Replace a faulty or leaky pump cartridge immediately. > Disconnect the control unit from the power supply when replacing the pump cartridge. > When changing the fuse, disconnect the control unit from the power supply and only use W&H original fuses. Tips > Only use tips approved by W&H and the associated tip changer or spanner. > An overview for the correct power setting is included with the respective tip. > With periodontal tips, the handpiece is suitable for the removal of concretions in the subgingival region, but not for applications which demand sterile conditions. > Ensure that the original shape of the tip is not changed (e.g. by dropping). > The tips must not be bent back to shape and reground. > Only insert the tip when the handpiece is at rest. > Never touch the tips when vibrating. > Place the tip changer onto the inserted tip of the handpiece at rest after each treatment (protection against injuries and infections, tip protection). Tips that are changed using the spanner must be removed immediately after treatment with the handpiece. > Check for the effect of wear on the tips using the accompanying tip card. > Change tips if there are visible signs of wear.

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6. Description front panel

Coolant tank

Tray

Handpiece support (adjustable)

PLUS / MINUS buttons for power Power indicator

Coolant indicator Supply hose with coupling

LED indicator test on every restart

PLUS / MINUS buttons for coolant flow rate 16

Description rear panel

Power switch I / O (ON / OFF)

Fuse holder with 2 fuses

Power socket

Connecting socket for foot control

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7. Starting operation – General Always place Tigon on a flat level surface. Make sure that it is easy to disconnect Tigon from the power supply.  Fill the coolant tank and attach it. The coolant tank snaps into place. Always remove the coolant tank for refilling. The filling level indicator does not serve to ensure the coolant supply.

 Insert the tray.

 Attach the handpiece support. You can adjust the handpiece support by turning it.

 Connect the mains cable and the foot control. Pay attention to the positioning!

 Attach the handpiece to the supply hose. Pay attention to the positioning of the connections! 18

8. Insert/remove tip with tip changer Inserting the tip

Removing the tip

 Position the tip on the handpiece thread.

 Attach the tip changer to the tip.

 Turn the tip changer until it snaps into place.

 Twist off the tip with the tip changer.

 Carefully pull off the tip changer. Check the secure attachment of the tip by pulling axially. Press the tip on a hard surface with approx. 1 N (=100 g) to test the load bearing capacity of the tip.

Leave the tip in the tip changer until the hygiene and maintenance process!

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Insert/remove tip with spanner Inserting the tip

Removing the tip

 Position the tip on the handpiece thread.

 Screw off the tip with the spanner.

 Screw the tip tight with the spanner. Check the secure attachment of the tip by pulling axially.

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