piezomed PLUS SA-435 M and CLASSIC SA-430 M Instructions for Use Rev 005

Contents Symbols... 4 1. Introduction... 7 2. Unpacking... 9 3. Scope of delivery ... 10 4. Safety notes... 11 5. Description... 16 6. Start-up... 19 7. Operation... 23 8. Icons... 26 9. Error messages... 29 10. Hygiene and maintenance... 31 General notes... 31 Limitations on processing... 32 Initial treatment at the point of use... 33 Manual cleaning... 34 Manual disinfection... 35 Automated cleaning and disinfection... 36 Drying... 37 Inspection, maintenance and testing... 38 Packaging... 39 Sterilization... 40 Storage... 42 11. Service... 43 12. A ccessories, consumables, spare parts and other recommended medical devices by W&H... 45 13. Technical data... 47 2

Contents 14. Data on electromagnetic compatibility according to IEC/EN 60601-1-2... 49 15. Disposal... 52 W&H course certificate... 54 Explanation of warranty terms... 57 Authorized W&H service partners... 58

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Symbols

4

in the Instructions for Use

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

Thermo washer disinfectable

Sterilizable up to the stated temperature

General explanations, without risk to persons or objects

Symbols Follow Instructions for Use

Foot control

Catalogue number

Date of manufacture

Manufacturer

Serial number

Do not dispose of with domestic waste

CE marking with XXXX identification number of the Notified Body

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

25UX

on the medical device

DC – direct current Electric voltage (volt)

Medical Device Frequency (hertz)

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/ (R)2012 + A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012, ANSI/AAMI ES60601-1:2005/A2:2021, CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1:14/A2:22, IEC 80601-2-60:2019. 25UX – Control No.

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Symbols

on the packaging

CE marking with identification XXXX number of the Notified Body

DataMatrix Code for product information including UDI (Unique Device Identification) Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard.

This way up

Fragile, handle with care

+70 °C (+158°F) Max.

Temperature limitation

-40 °C (-40°F) Min.

80 %

Humidity limitation

8%

25UX

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Serial number Date of manufacture Manufacturer

Data structure in accordance with Health Industry Bar Code

Keep dry

“Der Grüne Punkt” (The Green Dot) trademark of Duales System Deutschland GmbH

Catalogue number

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES606011:2005/(R)2012 + A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012, ANSI/AAMI ES60601-1:2005/A2:2021, CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1:14/A2:22, IEC 80601-2-60:2019. 25UX – Control No.

Caution! Federal law restricts this device to sale by or on the order of a physician, dentist, veterinarian or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.

1. Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your medical device. 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. Observe the safety notes. Intended use Drive unit with a piezoceramic oscillating system for treatment of organic hard and soft tissue in dental surgery, implantology, maxillofacial surgery and periodontics. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. Qualifications of the user Only suitably qualified medical, technical and specialist trained staff may use the medical device. We have based our development and design of the medical device on the physician target group.

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Introduction Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions: > > > >

The medical device must be used in accordance with these Instructions for Use. The medical device has no components that can be repaired by the user. Modifications or repairs must only be undertaken by an authorised W&H service partner (see page 58). The electrical installation at the premises must comply with the regulations laid out in 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 medical device invalidates all claims under warranty and any other claims. Improper use, unauthorized assembly, modification of or repairs to the control unit or the handpiece with cable and non-compliance with our instructions or the use of accessories and spare parts unauthorized by W&H will void the warranty and release us from all other claims. Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the competent authority!

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2. Unpacking  Remove the carton.

 Remove the packaging and remove the power supply, irrigation tubing set and accessories.

 Lift out the insert with the stand, Instructions for Use, universal support, control unit and mains cable.

W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging. 9

3. Scope of delivery Control unit REF 07721800

30406000 Universal support

REF 08067690 Stand Mains cable country-specific

30407000 X X X

Optional included in set REF 30392000 Handpiece SA-40 L with 1,8 m cable (only for SA-435 M) REF 30392001 Handpiece SA-40 L with 3,5 m cable (only for SA-435 M) REF 30408000 Handpiece SA-40 with 1,8 m cable REF 00636901 Nozzle cleaner REF 30264000 Foot control S-NW REF 30285000 Foot control S-N2 REF 06276700 Instrument changer REF 07883900 Power supply REF 08072750

Irrigation tubing set 2,2 m incl. Y-manifold (6 pcs. disposable)

REF 08041710

Irrigation tubing set 3,8 m incl. Y-manifold (6 pcs. disposable)

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4. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > Check the medical device for damage and loose parts each time before using. > Do not operate the medical device if it is damaged. > Check the parameter settings every time you restart. > In case of coolant supply failure, the medical device must be stopped immediately. > Perform a test run each time before using. > Avoid overheating at the treatment site. > The responsibility for the use and timely shutdown of the system lies with the user. > Ensure that it is possible to complete the operation safely should the units or instruments fail. > Never touch the patient and the electrical contacts on the medical device simultaneously. > Make sure that no computer viruses are transferred to the control unit by an external data medium (USB stick).

The medical device is classed as “conventional equipment” (closed equipment without protection against the ingress of water). The medical device is not approved for operation in potentially explosive atmospheres. The medical device is not approved for operation in oxygen rich Environment.

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Safety notes Power failure In the event of a power failure, if the control unit is switched off, or when switching between programs, the last values set are saved and re-activated on power-up. System failure A total system failure does not constitute a critical fault. Mains cable/Power supply > Only use the power mains cable/supply supplied. > Plug the mains cable only into a power socket with protective contact. Disconnect the medical device in dangerous situations from the power supply! > Pull the power plug/power supply out of the socket.

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Safety notes Risks due to electromagnetic fields The functionality of active implantable medical devices (AIMD) (e.g. cardiac pacemaker, ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if the patient has active implantable medical devices (AIMD) before using the medical device and inform about the risks.

Foot control Follow the directions and safety notes in the Instructions for Use of the foot control. Foot control S-NW Keep the ORANGE button pressed to switch between the control units.

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Safety notes Coolant supply The medical device is designed for use with physiological saline solution. > Always ensure the correct operating conditions and cooling function. > Use only suitable coolants and follow the manufacturer’s medical data and instructions. > Use the W&H irrigation tubing set or accessories approved by W&H.

Irrigation tubing set > Sterile disposable irrigation tubing sets are supplied with the equipment. > Note the expiration date and only use disposable irrigation tubing with undamaged packaging. > Replace the disposable irrigation tubing immediately after every treatment. > Follow your local and country-specific laws, directives, standards and guidelines for disposal.

Change application When changing the application a acoustic signal sounds (risk of injury).

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Safety notes Hygiene and maintenance prior to initial use > Clean the control unit. > Clean and disinfect the universal support and the stand. > Sterilize the universal support. Test run Do not hold the handpiece with cable at eye level! > Attach the handpiece with cable to the control unit. > Insert the instrument. > Put the control unit into operation. In the event of operating malfunctions (e.g., vibrations, unusual noise, overheating, coolant failure or leakage) stop the medical device immediately and contact an authorized W&H service partner.

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5. Description

SA-430 M / SA-435 M Stand holder

Connection for power supply Connection cable

Connection for handpiece

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Connection for foot control

Description

foot control S-N2/S-NW Locator attach/detach

ORANGE

GREEN YELLOW

GREY Start motor (pedal) ON/OFF

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Description

of foot control S-N2 / S-NW

ORANGE S-N2/S-NW: Change program Press the ORANGE button to change programs in ascending order. When changing from the last program to the first program a longer acoustic signal sounds (risk of injury). S-NW: Switching between multiple control units Press the ORANGE button for 3 seconds. S-NW: Change application Press the ORANGE button for 3 seconds until an acoustic signal sounds. S-N2: Change application Press the ORANGE button for 3 seconds until an acoustic signal sounds. GREEN Press the green button to change the coolant volume in steps of 20% Press and hold the GREEN button to activate the coolant filling function. YELLOW Boost function Press and hold the YELLOW button to activate the boost function. The boost function increases the power to 100% for 15 seconds. 18

6. Start-up Place the medical device on a flat level surface. Ensure that the medical device can be disconnected from the power supply at any time.  Attach the control unit until it engages.

 Connect handpiece cable. Pay attention to the positioning!

 Connect the connection cable to the SI-10xx foot control connection. Connect the power supply, foot control or dongle to the SA-4xx M. Pay attention to the positioning!

 Insert the stand. Pay attention to the positioning!

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Start-up  Attach the universal support and lock it.

 Insert the irrigation tubing. > Open the pump cover (a,b). > Insert the irrigation tubing (c). > Close the pump cover (d).

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