Proxeo Scaler Instructions for Use

Contents Symbols... 4 – 5 in the Instructions for use, on the instrument / packaging 1. Introduction... 6 – 8 2. Safety notes... 9 – 13 3. Product description... 14 – 18 Scaler, Tips 4. Starting operation... 19 – 22 Attachment/detachment, Changing the tip, Test run 5. Hygiene and maintenance... 23 – 36 General, Pre-disinfection, Manual cleaning, Manual disinfection, Mechanical cleaning and disinfection, Oil service, Sterilization 6. Replacing the bulb (ZA-55 L)... 37 – 38 2

Contents 7. W&H Accessories and spare parts...39 – 40 8. Technical data... 41 – 42 9. Disposal...43 Explanation of warranty terms... 44 Authorized W&H service partners...45

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Symbols in the instruction for use

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

Suitable for use in an ultrasonic bath

Do not dispose of with domestic waste

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Symbols on the instrument / packaging XXXX

CE marking with identification number of the Notified Body

DataMatrix Code for product information including UDI (Unique Device Identification)

Data structure in accordance with Health Industry Bar Code

Catalogue number

Thermo washer disinfectable

Sterilizable up to the stated temperature

Serial number Date of manufacture

UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements 5

1. Introduction The W&H quality policy gives customer satisfaction top priority. This W&H product has been designed, manufactured and tested in accordance with the requirements of current laws and standards. For your safety and the safety of your patients Please read the Instructions for use before using the device for the first time. They explain how to use the product and guarantee smooth, economical and safe operation. Intended use This medical device is an air-powered ultrasonic unit for use in dental treatments. It may be used in combination with the tips approved by the manufacturer for the removal of supragingival and subgingival calculus, tooth cleaning, root planing, root canal preparation and processing hard tooth and bone substance. Misuse may damage the scaler and hence cause risks and hazards for patients, users and third parties. 6

Qualifications of the user We have based our development and design of the scaler on the requirements of the »dentists, dental hygienists, dental employees (prophylaxis) and dental assistants« target group. Production according to EU Directive The scaler is a medical device as defined by EU Directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the scaler if it is used in compliance with the following directions: > The scaler must be used in accordance with these Instructions for use. > The scaler 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 45). 7

Qualified use The scaler 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. The scaler must only be prepared and maintained by persons who have been instructed in infection prevention, self-protection and patient safety. Improper use (e.g., due to lack of hygiene and maintenance), non-compliance with our instructions or the use of accessories and spare parts which have not been approved by W&H will invalidate all claims made under warranty or otherwise. Service In case of malfunction, contact an authorized W&H service partner immediately (see page 45). Repair and maintenance work must be performed exclusively by authorized W&H service partners.

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2. Safety notes > Operation of the scaler with light is only permitted on supply units that conform to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). The power supply unit for the supply unit must meet the following requirements, which must be guaranteed by the system assembler: > Double insulation for the maximum anticipated supply voltage between the primary and secondary circuit. > Double insulation for the maximum anticipated secondary voltage between the secondary voltage and the protective earth (PE). > The secondary circuits must be electrically isolated from one another. > The secondary circuits must be protected against short-circuit and overload. > The leakage currents of the applied part must be in compliance. > The secondary voltage must be limited to max. 3.3 V AC/DC.

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> Always ensure correct operating conditions and that sufficient and adequate cooling is delivered. > Always provide sufficient coolant and ensure the appropriate suction. Turn off the scaler immediately in the event of failure in the coolant supply. > As drive air for the scaler, use only filtered, oil-free and cooled air supplied by dental compressors. > Check the scaler for damage and loose parts (e.g., scaler tip) before every use. > Do not operate the scaler if it is damaged. > Perform a test run prior to each treatment. > Do not use the scaler where soft tissue injuries exist in the oral cavity (the air pressure may cause septic substances to infiltrate the tissue or trigger embolisms). > Run the rinsing function of the dental unit once a day > Do not use the scaler as a light sensor. > Avoid eye contact with the optic outlet.

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Tips > Only use W&H tips and the W&H tip changer or tips/tip changers from another manufacturer which are approved for the W&H scaler. > 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. > Check the set power setting every time the device is restarted. > Only insert the tip when the scaler is idle. > Never touch the vibrating tip. > Place the tip changer on the inserted tip of the idle scaler immediately after every treatment (protects against injuries and infections, protects the tip). > Use the tip card supplied to check the wear to the tips (1AU, 2AU, 3AU, 1AP, 2APr, 2APl). The wear of the tips must not amount to more than 2 mm.

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Danger zones M and G The scaler is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide according to IEC 60601-1/ANSI/AAMI ES 60601-1. The scaler 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 disinfectant agents, 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. 12

Hygiene and maintenance before using for the first time The scaler is supplied in a clean condition sealed in PE foil. > Lubricate the scaler before using it for the first time. > Sterilize the scaler, tips, tip changer and the nozzle cleaner. > Oil service > Sterilization

page 33 – 34 page 35 – 36

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2. Product description – Scaler Scaler with/without light and Roto Quick connection

1

2

ZA-55 L

ZA-55

 Tip changer  Nozzle cleaner  Optic outlet*  Power level marking*  Adjuster ring for the power setting*  Bulb*  Bulb holder*  Spray filter*  Allen key*  Small cleaning brush * Only on ZA-55 L

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Scaler with/without light and Multiflex® / Sirona® connection  Tip changer  Nozzle cleaner  Optic outlet*  Power level marking*  Adjuster ring for the power setting*  Small cleaning brush

1

2

ZA-55 LM

ZA-55 M

* Only on ZA-55 LM / ZA-55 LS

1

2

ZA-55 LS

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Adjuster ring for the power setting on the scaler with light (ZA-55 L / ZA-55 LM / ZA-55 LS)

2

3

1

2

> Power level marking 1: Gentle > Power level marking 2: Standard > Power level marking 3: Short-term for increased ablation Power level marking 3: Avoid any type of overinstrumentation.  Set power level 1 to 2 by turning the adjuster ring. > There is a safety lock at power level 2.  To bypass it, press the adjuster ring forwards and turn it to power level 3. 16

Product description – Tips Application areas of approved W&H tips The following tips have been approved for power level marking 1 – 3 (ZA-55 L / ZA-55 LM / ZA-55 LS). Prophylaxis tips 1AU: Universally applicable, also for cambered molar surfaces inclined towards lingual. 2AU:

For anterior teeth of the lower jaw, lingual surfaces and in cases of stubborn adhesion of thick, hard collars of dental calculus.

3AU:

For removing plaque from the neck of the tooth and removing nicotine stains. 17

Periodontology tips 1AP: Removal of subgingival deposits, especially suitable for deep periodontal pockets. 2APr: Right-curved tip for removal of subgingival deposits.

2APl: Left-curved tip for removal of subgingival deposits.

3AP:

With a diamond coating on the instrument tip for periodontal debridement of furcations and concavities. Use the diamond-coated 3AP periodontology tip, applying very light pressure (0.3 N) to avoid any type of overinstrumentation.

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4. Starting operation Attachment and detachment

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2

1

2

1

2

Do not attach or detach while in operation!  Place the scaler on the Roto Quick / Multiflex® / Sirona® coupling.  Check that the scaler is securely attached to the coupling.  Retract the Roto Quick coupling's retention sleeve and detach the scaler by pulling axially. or Remove the scaler from the Multiflex® / Sirona® coupling by pulling axially. 19

Inserting the tip  Place the tip in the notch.  Push the tip into the tip changer.  Insert the thread of the tip into the opening on the scaler.  Screw the tip in tightly.  Pull the tip changer off carefully. Check the secure attachment of the tip by pulling axially. Press the tip against a hard, sterile surface (e.g., tip changer) with approx. 10 N (=1 kg) to test the load-bearing capacity of the tip. 20