Prosthodontic Screwdriver Instructions for Use

Contents 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.

W&H Symbols... 3 – 5 Introduction... 6 – 8 Electromagnetic compatibility (EMC)...9 Scope of delivery...10 Safety notes... 11 – 16 Description – Charging station... 17 Description – Handpiece drive / Contra-angle handpiece / Rechargeable battery...18 Description – Operating controls...19 Starting operation – Charging rechargeable battery... 20 Starting operation – switch on / switch off prosthodontic screwdriver... 21 Starting operation – Assembly / removal of the contra-angle handpiece... 22 Starting operation – Assembly / removal of the key pad...23 To change rotary instrument (e.g. insertion tools)...24 Test run...25 Operation – Setting the torque...26 Operation – Switching between forward / reverse operation mode...27 Replacing the rechargeable battery... 28 Troubleshooting...29 – 30 Hygienic maintenance... 31 – 37 W&H Accessories... 38 Servicing...39 – 40 Technical data... 41 – 42 Recycling and disposal...43 Explanation of warranty terms...45 Authorized W&H service partner...47 2

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

W&H Service

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W&H Symbols Symbols on rechargeable battery / charging station / contra-angle handpiece / handpiece drive Consult instructions for use Class II equipment

Not suitable for intracardiac application – Type BF applied part Do not dispose of with domestic waste

Date of manufacture CE 0297 from the manufacturer

Thermo washer disinfectable Sterilizable up to the stated temperature Not sterilizable

Data Matrix Code for product identification, e.g. in hygiene / maintenance process MEDICAL – GENERAL MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1:2006, CAN/CSA-C22.2 No. 601.1-M90, CAN/CSA-C22.2-No. 60601-1:08, ANSI/AAMI ES 60601-1:2005. 25UX (Control No.)

REF Catalogue number SN

Serial number

V

Supply voltage of the unit

AC

Alternating current

A

Supply current

Hz

Frequency of the alternating current

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W&H Symbols Symbols on the packaging This way up

Temperature limits

Fragile, handle with care

Humidity limitation

Keep away from rain

CE 0297 from the manufacturer

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

RE Y

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

Data Matrix Code for product identification, e.g. in hygiene / maintenance process

General symbol for recovery/ recyclable 5

1. Introduction For your safety and the safety of your patients These Instructions for Use 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 to read the safety notes on Pages 11 to 16.

Intended use The prosthodontic screwdriver is an electronically controlled screw system with adjustable torque for fixing and removing prosthesis retaining screws. It consists of: a battery-operated handpiece drive a 80:1 mechanical transmission instrument (contra-angle handpiece) Misuse may damage the prosthodontic screwdriver and hence cause risks and hazards for patients, users and third parties.

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Introduction Qualifications of the user We have based our development and design of the prosthodontic screwdriver on the »dentists« target group. Skilled application The prosthodontic screwdriver is intended only for informed use in the medical dental field according to its purpose of use in compliance with the valid health and safety at work regulations and the valid accident prevention regulations as well as in compliance with these Instructions for use. The prosthodontic screwdriver should be prepared for use and maintained by staff who have been trained in procedures for infection control, personal safety and patient safety. Improper use, (e.g. through poor hygienic maintenance), non-compliance with our instructions or the use of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any other claims.

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Introduction 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 it applies to the > Prosthodontic screwdriver IA-400 consisting of handpiece drive, charging station, contra-angle handpiece and rechargeable battery Li-lon 3.7 V 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 the prosthodontic screwdriver when it is used in compliance with the following directions: > The prosthodontic screwdriver must be used in accordance with these Instructions for use. > The prosthodontic screwdriver has no components that 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. > Unauthorized 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/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. Scope of delivery After unpacking the following parts must be present: Prosthodontic screwdriver set IA-400, consisting of ❍ Handpiece drive IA-40 H with key pad ❍ Contra-angle handpiece IA-80 with hexagon chuck system ❍ Charging station IA-400 ❍ Rechargeable battery Li-Ion 3,7 V REF 05451300 ❍ Mains cable REF 05464400 (Europe) Alternative specification ❍ Mains cable REF 05456100 (USA, CAN, J) / REF 05457700 (UK, IRL) / REF 05467600 (AUS, NZ)

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4. Safety notes It is essential to comply with the following Instructions when using the prosthodontic screwdriver: > Before using the handpiece drive and the charging station for the first time, store it at room temperature for 24 hours. > Check the handpiece drive, the contra-angle handpiece, the charging station and the mains cable for damage and loose parts prior to every use. Correct any faults or refer to an authorized W&H service partner (see page 47). Do not operate the Prosthodontic screwdriver if it is damaged. > Always ensure the correct operating conditions. > Only use the W&H IA-80 contra-angle handpiece. > Only attach the contra-angle handpiece when the handpiece drive is stationary. > Perform a test run prior to each treatment. > Do not activate the press-button of the contra-angle handpiece during operation or slowing down. This leads to detachment of the rotary instrument and overheating of the press button. > Do not place the Prosthodontic screwdriver on the patient!

Hygienic maintenance prior to initial use The prosthodontic screwdriver is in a clean condition when delivered. Disinfect the handpiece drive and the charging station (see Page 32). Sterilize the contra-angle handpiece and the key pad (see Page 36).

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Safety notes It is essential to comply with the following Instructions when using the rechargeable battery: > The Li-lon 3.7 V rechargeable battery is not sterilizable. > Only use W&H rechargeable batteries with REF 05451300. Other types of rechargeable battery may lead to a risk of fire or explosion. > Only use the W&H rechargeable battery REF 05451300 in connection with the W&H handpiece drive IA-40 H and the W&H charging station IA-400. > The rechargable battery used in the unit may cause a risk of fire or acid burns if not used properly (e.g. charging in a charging station other than the one provided). > The rechargeable battery must not be taken apart, heated to above 100 °C (212 °F) or burnt. > Do not short-circuit a rechargeable battery. > Do not subject rechargeable batteries to mechanical shock. > Defective or disused rechargeable batteries must be disposed of immediately. > In the event of a rechargeable battery leaking, do not allow the liquid to come in contact with the skin or eyes. If contact has been made, wash the affected area with copious amounts of water ans seek medical advice. > Keep the rechargeable battery out of the reach of children. Use only suitable and serviceable tools Ensure that you comply with the manufacturer's instructions for prosthodontic screws with respect to maximum torque, proper use and forward/reverse operation. Inappropriate use Improper use, in addition to incorrect assembly, installation, modification or repairs of the prosthodontic screwdriver or non-compliance with our instructions invalidates all claims under warranty and any other claims. 12

Safety notes Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator) can be affected by electric, magnetic and electromagnetic fields. > Find out if patient and user have implanted device before using the product and consider the application. > Weigh the risks and benefits > Keep the product away from implanted systems. > Make appropriate emergency provisions and take immediate action on any signs of ill-health. > Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD (implantable cardioverter defibrillator).

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Safety notes Danger zones M and G In accordance with IEC 60601-1/ANSI/AAMI ES 60601-1, the prosthodontic screwdriver are not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide. Prosthodontic screwdriver is not suitable for use in oxygen enriched atmospheres. Zone M is defined as a »medical environment« and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anaesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle. Zone G, also known as an »enclosed medical gas system«, does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities.

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Safety notes Prosthodontic screwdriver (handpiece drive) The unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water). The W&H handpiece drive IA-40 H is intended for use with the charging station IA-400. Use of other handpiece drives / charging stations could damage or destroy the electronics / the rechargeable battery. Mains cable Only use the mains cable supplied. Set up the charging station so that the power switch is easily accessible. In dangerous situations, the charging station can be disconnected from the power supply using the power switch or mains cable. The power switch can also be used to safely stop the charging station. System failure A total system failure of the prosthodontic screwdriver does not constitute a critical fault. Simply switch the device off and then on again.

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Safety notes The patient’s surroundings (see illustration) are deemed to be an area of 2.50 m above and 1.83 m around the patient. 2,5 m

Do not use the charging station in the patient’s surroundings.

3m

1,83 m

1,8

1,83 m

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5. Description – Charging station

Charging port for handpiece drive

Power control LED (ON, green)

Charge control LED (orange)

Power socket Power switch I / 0 (ON / OFF)

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6. Description – Handpiece drive / Contra-angle handpiece / Rechargeable battery Coupling for contra-angle handpiece

Key pad Motor ON / OFF

Press-button

Operating controls

Charging contacts

Plug contact for handpiece drive

Rechargeable battery cover 18

7. Description – Operating controls Display PLUS key Key

Increase torque

ON, forward/reverse operation mode

MINUS key Decrease torque

When the handpiece drive is switched on, the following displays can be seen:

 Display test »88«  Rechargeable battery capacity display  Last setting used 19

8. Starting operation – Charging battery Always place the charging station on a flat level surface. Ensure that the charging station can be disconnected easily from the power supply. > Charge the rechargeable battery completely before the first use. This will take about 100 minutes. > The handpiece drive can remain on the switched-on charging station until the next use. > If the rechargeable battery has enough capacity, the charge control LED (orange) will light up briefly (for about 1 sec.). Rechargeable battery is not charging. > If the rechargeable battery does not have enough capacity, the charge control LED (orange) lights up. Rechargeable battery is charging.

 Plug the mains cable into

 Rechargeable battery is

the charging station.

charged. Charge control LED (orange) goes out.

 Place the handpiece drive in the charging station. Rechargeable battery is charging. Charge control LED (orange) lights up. 20