tigon + PA-123 and PA-115 Instructions for Use Rev 010 Jan 2015

Contents W&H symbols...4 – 6 1. Introduction...7 – 8 2. Electromagnetic compatibility (EMC)... 9 3. Unpacking...10 4. Equipment supplied ... 11 5. Safety notes...12 – 16 6. Description of front panel / rear panel...17 – 18 7. Description of tips... 19 – 22 8. Starting operation – General... 23 – 24 9. Starting operation – S-N1 foot control...25 10. Tip insertion / removal... 26 – 27 11. Switching Tigon+ on / off...28 12. Control unit operation – Setup settings...29 – 34 13. Factory settings...35 14. Control unit operation – Main menu settings...36 – 40 15. Test run... 41 16. Error messages... 42 – 44

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Contents 17. Hygiene and maintenance... 45 – 53 18. Replacing the O-rings...54 19. Replacing the coolant filter...55 20. Replacing the pump cartridge... 56 – 57 21. W&H accessories... 58 – 60 22. Servicing...61 23. Technical data...62 – 63 24. Recycling and disposal...64 Explanation of warranty terms...65 Authorized W&H service partners... 67

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W&H symbols 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

W&H Service 4

W&H symbols Symbols on the Tigon+ Follow instructions for use

Data matrix code for product identification e.g. for hygiene / maintenance processes

Consult instructions for use

Do not dispose of with domestic waste

Class II equipment

Foot switch

Date of manufacture

MEDICAL – GENERAL MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND 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.)

Electric fuse Not suitable for intracardiac application – Type B applied part

REF Catalogue number SN

Serial number

V

Supply voltage of the unit

AC

Alternating current

W

Electric power consumption of the unit

A

Supply current

Hz

Frequency of the alternating current

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W&H symbols Symbols on the packaging This way up

Temperature limit

Fragile, handle with care

Humidity limitation

Keep away from rain

CE0297 from manufacturer

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

»Der Grüne Punkt« Identification mark of Duales System Deutschland AG RE Y

General symbol for recovery/recyclable 6

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 12 – 16. 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, personal 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 and any 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 EU Directive 93/42/EEC has been used as a basis in the design and manufacture of this medical product and this applies to > Tigon+ in the condition as supplied by us. This declaration does not apply to non-specified fittings, mountings etc.

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 67). > 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. > Unauthorized opening of the equipment invalidates all claims under warranty and any other claims. 8

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/en_global/emc alternatively, you can obtain it 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 containing the accessories 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 containing the coolant tank.

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4. Equipment supplied After unpacking, you should have the following parts: REF 13931000  Control unit (230 V), (incl. 1.8 m supply hose with coupling, tray, handpiece support and coolant tank) REF 06028700  Handpiece PA-1 LED REF 06373900  Tip set: Tip changer with universal tip 1U, 3U and periodontal tip 1P inserted REF 05851800  Tip set: Tip changer with Implant Clean tip 1I and Endo tip 1E with spanner REF 06382800  S-N1 foot control REF 06382200  Handle for SN-1 foot control REF 04653500  Coolant hose (Ø 6 mm, approx. 2 m) REF 05075600 with coolant filter REF 02675000  Nozzle cleaner REF 00636901  O-ring for hose coupling REF 02060203 (2 pcs)  O-ring for hose coupling REF 05417700 (1 pc)  Tip card (2 pcs)  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 13931001  Control unit (115 V), (incl. 1.8 m supply tube with coupling, tray, handpiece support and coolant tank) REF 06479400 11

5. Safety notes Inappropriate use Improper use, in addition to incorrect assembly, installation, modification or repairs of Tigon+ or failure to comply with our instructions invalidates all claims under warranty and any other claims The control unit is designed for use with the W&H handpiece PA-1 LED so only this is to be used with the control unit. The use of other handpieces could lead to a malfunction 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 does not constitute a critical fault. Simply switch the unit off and then on again. 12

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. Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and ICDs (implantable cardioverter defibrillators) can be affected by electric, magnetic and electromagnetic fields. > Tigon+ must not be used on patients with cardiac pacemakers or ICDs (implantable cardioverter defibrillators). > Tigon+ must not be used by persons who are themselves patients with cardiac pacemakers or ICDs (implantable cardioverter defibrillators). > Before using the product, check that it can be used by asking patients if they have have an implanted device. > Keep the product away from implanted devices. 13

Safety notes > 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. > Do not connect Tigon+ to the hot water supply. > Rinse the supply hose through once a day (rinsing function page 30 – 31). > Never fill or top up the coolant tank with liquids hotter than 30 °C. > Only use coolants, rinsing/cleaning 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% Approved cleaning agents > 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 > Tigon+ approved for use only with supply units with category 5 backflow prevention devices as defined in EN 1717. > Provide sufficient space for unrestricted operation of the foot control. > 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. Exception for endodontic applications, here use is without coolant. Max. operating time without coolant is: > 2 minutes in the power range 1 – 30 > 30 seconds in the power range 31 – 40 > 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 67). Do not operate Tigon+ if it is damaged. > 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 connections for the foot control or coolant hose simultaneously. > Switch Tigon+ off after every application. > Disconnect Tigon+ from the water supply connection after each use (the control unit does not have an automatic aquastop).

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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 each tip. > Ensure that the original shape of the tip is not changed (e.g. by dropping). > Tips must not be bent back to shape or 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 (exception: tips 1E, 2E, 3E) (protection against injuries and infections, tip protection). > Use the tip card supplied to check the wear to the tips (1U, 2U, 3U, 4U, 1P, 2Pl, 2Pr, 3Pl, 3Pr, 1E, 2E, 3E). > Replace tip 1I in the event of visible material wear.

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6. Description front panel

Coolant tank Display

Tray

Handpiece support (adjustable)

Navigation buttons Standby button

PLUS / MINUS buttons

Supply hose with coupling Coolant tank button

SET button

Coolant fixed connection button

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Description rear panel

Connecting socket for S-N1 foot control

Power switch I / O (ON / OFF)

Fuse holder with 2 fuses

Power socket

Connecting socket for C-NF foot control (optional)

Connection for coolant hose

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7. Description of tips Area of application of the tips approved by W&H. Universal tips 1U: For coarse depuration of supragingival plaque.

2U:

For fine depuration of supragingival plaque and for treating recall patients.

3U:

For fine depuration of supragingival plaque, especially suitable for interdental cleaning.

4U:

For coarse depuration of supragingival plaque, especially for removal of large plaque areas.

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Description of tips With the tips 1P, 2Pr, 2Pl, 3Pr, 3Pl the handpiece is suitable for removal of concretions in the subgingival area; however, not for applications that require sterile conditions. Periodontal tips 1P: Removal of subgingival deposits, especially suitable for deep periodontal pockets.

2Pr:

Right-curved tip with a small ball (0.6 mm diameter) on the instrument tip for periodontal debridement of furcations and concavities.

2Pl:

Left-curved tip with a small ball (0.6 mm diameter) on the instrument tip for periodontal debridement of furcations and concavities.

3Pr:

Right-curved tip for periodontal debridement, recommended for maintenance treatment on medium depth to deep pockets as well as furcations.

3Pl:

Left-curved tip for periodontal debridement, recommended for maintenance treatment on medium depth to deep pockets, as well as furcations. 20