Piezomed Ultrasonic Bone Cutting System Instructions for Use

Contents Symbols... 4 1. Introduction... 8 2. Electromagnetic compatibility (EMC)... 10 3. Unpacking... 11 4. Scope of delivery...12 5. Safety notes...13 6. Description... 19 of front panel... 19 of rear panel... 20 Foot control S-N1/S-NW...21 Handpiece with cable... 23 7. Start-up... 24 8. Instruments... 27 Insert/remove ... 27 9. Setup settings... 28 Control unit... 28 Foot control S-N1... 29 Volume... 30 Reset factory settings... 31 10. Operation... 32 Changing the program (P1 – P3)... 33 Changing power... 34 Changing the coolant flow... 35 Changing the operating mode... 36 11. Factory settings... 37 2

Contents 12. Error messages... 38 13. Emergency mode... 40 14. Hygiene and maintenance... 42 General notes... 42 Limitations on processing... 43 Initial treatment at the point of use... 44 Manual cleaning... 45 Manual disinfection... 48 Automated cleaning and disinfection... 49 Drying... 50 Inspection, maintenance and testing... 51 Packaging... 52 Sterilization... 53 Storage... 55 15. Service... 56 16. W&H accessories and spare parts... 58 17. Technical data... 60 18. Disposal... 62 W&H course certificate... 64 Explanation of warranty terms ... 67 Authorized W&H service partners... 68 Open Source Software... 69 Manufacturer’s declaration... 70

3

Symbols

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 ultrasonic bath

Type B applied part (not suitable for intracardiac application) 4

in the Instructions for Use

Symbols Follow Instructions for Use

Class II equipment

Catalogue number

Date of manufacture

Foot control

Serial number

Do not dispose of with domestic waste

On / Off

Supply voltage

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

Electric fuse

Alternating current

Earth

Power consumption of the control unit

Medical Device

Supply current

CE marking with identification XXXX number of the Notified Body

25UX

on the control unit

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005, ANSI/AAMI ES60601-1: A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012, CAN/ CSA-C22.2 No. 60601-1:2008, CSA CAN/CSA-C22.2 NO. 60601-1:2014. 25UX – Control No.

Frequency of the alternating current Manufacturer

5

Symbols

on the packaging

CE marking XXXX with identification number of the Notified Body

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

This way up

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

Fragile, handle with care

+70 °C (+158°F) Max.

Temperature limitation

-40 °C (-40°F) Min.

80 %

Humidity limitation

Medical Device 8%

25UX

6

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 ES 60601-1:2005, ANSI/AAMI ES60601-1: A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012, CAN/CSA-C22.2 No. 60601-1:2008, CSA CAN/CSA-C22.2 NO. 60601-1:2014. 25UX – Control No.

Caution! Federal law restricts this device to sale by or on the order of a dentist, physician, 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.

Symbols XXXX

on the irrigation tubing set

CE marking with identification number of the Notified Body

Not for re-use

Latex-free

Batch code

Use by

Sterilization with ethylene oxide

Catalogue number

Manufacturer

Keep away from heat

Do not resterilize

Do not use when package is damaged

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

Caution! Federal law restricts this device to sale by or on the order of a dentist, physician, 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.

Data structure in accordance with Health Industry Bar Code

7

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 Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC.

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 authorized W&H service partner (see page 68). >> 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. In addition to unauthorized assembly, installation, modification of or repairs to the control unit and non-compliance with our instructions, improper use 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! 9

2. Electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions in regard 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 accessories and spare parts not approved by W&H can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference. HF communications equipment Portable HF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical device could result. The medical device may be interfered by other equipment, even if these other devices comply with CISPR (International special committee on radio interference) emission requirements. Use of this medical device adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this medical device and the other equipment should be observed to verify that they are operating normally. The medical device is not intended for use in the vicinity of HF surgical devices.

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

 Remove the irrigation tubing set.

 Lift out the insert with the control unit.

 Remove the carton containing the accessories supplied.

 Remove the sterilization cassette.

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

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4. Scope of delivery Control unit

30078000

30078001

X

30078003

30078004

30078005

X

X

X

REF 06985000

Handpiece with 1.8 m cable

REF 07159200

Handpiece with 3.5 m cable

REF 07004400

Foot control S-N1

REF 30264001

Foot control S-NW

REF 07795800

SPI dongle

REF 04653500

Handle for foot control

X

REF 436360

Irrigation tubing set 2.2 m (3 pcs, disposable item)

X

REF 436410

Irrigation tubing set 3.8 m (3 pcs, disposable item)

REF 07172900

Sterilization cassette

X

X

X

REF 07173100

Instrument set “Bone“

X

X

X

REF 07721800

Universal support

X

REF 04005900

Stand

X

REF 06276700

Instrument changer

X

REF 00636901

Nozzle cleaner

X

Mains cable country-specific

X

12

X X

30078006

30078007

X

X

X X X X

X

X X

X X

X

X X

X

X

X

X

X

X

X

X

X

X

5. 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 when the medical device 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. >> Do not look directly into the light source. >> Avoid overheating at the treatment site. >> Ensure that it is possible to complete the operation safely should the units or instruments fail. >> Only put the handpiece with cable into operation when the handpiece sleeve is attached. >> The responsibility for the use and timely shutdown of the system lies with the user. >> If the LED fails, change the LED socket. >> Only change the LED socket when the handpiece is stationary. >> Always operate the handpiece with the LED socket fitted. The medical device is not approved for operation in potentially explosive atmospheres. Do not twist or kink the cable! Do not coil it too tightly!

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Safety notes >> Use only original W&H fuses. >> Never touch the patient and the electrical contacts on the medical device simultaneously. The control unit is classed as ”conventional equipment” (closed equipment without protection against the ingress of water).

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 switch >> Only use the mains cable supplied. >> Plug the mains cable only into a power socket with protective contact. >> Set up the control unit so the power switch is easily accessible. Disconnect the medical device in dangerous situations from the power supply! >> Pull the power supply out of the socket. 14

Safety notes Instruments >> Only use instruments approved by W&H and the associated instrument changer. >> Make sure that the instrument used complies with the instrument group displayed. >> An overview for the correct power setting is included with each instrument. >> Ensure that the original shape of the instrument is not changed (e.g. by dropping). >> Instruments must not be bent back to shape or reground. >> Only insert the instrument when the handpiece is at rest. >> Never touch the instrument when vibrating. >> Remove the instrument from the handpiece after every treatment and place it in the instrument stand (provides protection against injury and infection). >> Ensure there is sufficient coolant directly at the treatment site. >> The instruments Z25P and Z35P may only be operated with a coolant setting of max. 50%. >> Keep the handpiece moving at all times when operating the instrument. >> Do not exert too much pressure on the instrument. This can cause the instrument to heat up or break, resulting in injury to the patient. >> Do not make any levering motions with the instrument. >> Never let the instrument run freely without coolant.

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Safety notes Risks due to electromagnetic fields This handpiece with cable complies with the reference values defined in EN 50527-2-1/2016 for active implantable medical devices (AIMD) and cardiac pacemakers. The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with unipolar and bipolar pacemakers or ICD, if a safety distance between the control unit and the cardiac pacemaker or ICD of at least 30 cm (11,8 inch) is maintained. >> Find out if patient or user have implanted systems before using the medical device and consider the application. >> Weigh the risks and benefits. >> Make appropriate emergency precautions 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.

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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 national laws, directives, standards and guidelines for disposal.

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Safety notes Hygiene and maintenance prior to initial use >> Clean the control unit. >> Clean and disinfect the handpiece with cable, the universal support, the stand, the instruments and the instrument changer. >> Sterilize the handpiece with cable, the universal support, the instruments and the instrument changer. 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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6. Description

of front panel

Pump cover

Stand holder

Display

Shift buttons

Pump cover OPEN PLUS / MINUS buttons Connection for handpiece

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Description

of rear panel

Stand holder

Connecting socket for foot control Power switch I / O (ON / OFF) Power socket

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Fuse holder with 2 fuses REF 06661800 (250 V – T1,25AH)