Implantmed SI-1023 Instructions For Use Rev 001 Dec 2016

Contents Symbols...3 – 7 1. Introduction... 8 – 9 2. Electromagnetic compatibility (EMC) ...10 3. Unpacking...11 4. Equipment supplied...12 5. Safety notes...13 – 21 6. Description of front panel... 22 7. Description of rear panel...23 8. Description foot control S-N2/S-NW... 24 – 25 9. Description of motor with cable...26 10. Start-up – General...27 11. Switching the control unit on/off... 28 12. Icons – Navigation / Information / Main menu / Programme / Setup...29 – 34 13. Starting operation – Setup wizard...35 14. Control unit operation – Main menu... 36 – 37 15. Control unit operation – Factory settings...38 – 40 16. Control unit operation – Setup... 41 17. Control unit operation – System...42 – 43 18. Control unit operation – Documentation (DOCU)...44 – 45 19. Error messages... 46 – 47 20. Hygiene and maintenance...48 – 53 21. W&H accessories and spare parts... 54 – 55 22. Servicing... 56 – 57 23. Technical data...58 – 59 24. Disposal... 60 Course certificates...61, 63 Explanation of warranty terms...65 Authorized W&H service partners... 67 2

Symbols in the Instructions for Use

WARNING! (if persons could be injured)

ATTENTION! (if property could be damaged)

General explanations, without risk to persons or property

Thermo washer disinfectable

Sterilizable up to the stated temperature

Call customer service

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Symbols on the control unit Follow Instructions for Use

Class II equipment

Article number

Consult Instructions for Use

Foot switch

Serial number

Date of manufacture

On / Off

V

Supply voltage of the control unit

Do not dispose of with domestic waste

Electric fuse

AC

Alternating current

Data Matrix code for product information including UDI (Unique Device Identification)

Type B applied part (not suitable for intracardiac application)

VA

Power consumption of the control unit

A

Supply current

Hz

Frequency of the alternating current

CE mark XXXX with identification number of the Notified Body The medical device with reference to electrical safety, mechanical safety and fire prevention conforms to 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.) 4

rpm Revolutions per minute (= rpm)

Symbols on the foot control CE mark XXXX with identification number of the Notified Body

Non-ionizing electromagnetic radiation

Article number

Do not dispose of with domestic waste

Battery compartment closed

Serial number

Data Matrix code for product information including UDI (Unique Device Identification)

Battery compartment open

Date of manufacture

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

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Symbols on the packaging CE mark XXXX with identification number of the Notified Body

Data Matrix code for product information including UDI (Unique Device Identification)

This way up

Data structure in accordance with Health Industry Bar Code

Fragile, handle with care

+70 °C (+158°F) Max.

Permitted temperature range

-40 °C (-40°F) Min.

Keep dry

80 %

Humidity, Limitation

8%

»Der Grüne Punkt« (The Green Dot) trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard 6

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.

Symbols on the irrigation tubing set Consult Instructions for Use

CE mark XXXX with identification number of the Notified Body

Batch code

Not for re-use

Latex-free

Use by

Sterilization with ethylene oxide

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.

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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.

Observe the safety notes on pages 13 to 21. Intended use Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN 13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF).

Misuse may damage the Implantmed and hence cause risks and hazards for patients, users and third parties.

Qualifications of the user The W&H Implantmed is intended for use by suitably qualified and trained medical, technical and specialist staff only. We have based our development and design of the Implantmed on the "physician" target group.

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Introduction Production according to EU Directive The medical device complies with the regulations of Directive 93/42/EEC.

Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the Implantmed when compliance with the following instructions is ensured: > The Implantmed must be used in accordance with these Instructions for Use. > The Implantmed 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 67). > 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 control unit invalidates all claims under warranty and any other claims.

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2. 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 only guarantees compliance of the control unit with the EMC Directives when it is used with original W&H accessories and spare parts. The use of accessories and spare parts that have not been approved by W&H may lead to increased emission of electromagnetic interference or to reduced resistance to electromagnetic interference. You can find the current EMC manufacturer’s declaration on our website at http://wh.com or, alternatively, you can also request a copy 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  Remove the packaging.

 Remove the foot control, instructions for use and accessories.

 Remove the motor with cable.

 Lift out the insert with the control unit. Remove the mains cable, irrigant support, universal support, irrigation tubing set and instructions for use.

W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging. 11

4. Scope of delivery REF

Description

30288000

Control unit SI-1023 (230 V)

30289000

Control unit SI-1015 (115 V)

30290001

Control unit SI-1010 (100 V)

30281000

EM-19 LC motor with electrical contacts and 1.8 m cable incl. 5 hose clips

30185000

EM-19 motor without electrical contacts with 1.8 m cable incl. 5 hose clips

04363600

Irrigation tubing set 2.2 m (3 pcs, disposable)

07721800

Universal support

04005900

Irrigant support

01343700

EU mains cable

02821400

Mains cable USA, CAN, J

03212700

Mains cable UK, IRL

04280600

Mains cable CH

05901800 02909300 05333500

Mains cable DK Mains cable AUS, NZ Mains cable BR

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5. Safety notes – General > Before using the Implantmed for the first time, store it at room temperature for 24 hours. > Check the control unit and the motor with cable for damage and loose parts every time before use. > Do not operate the control unit and the motor with cable if it is damaged. > Check the parameter settings every time the device is restarted. > Perform a test run prior to every treatment. > 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. Control unit > Use only original W&H fuses > Never touch the patient and the electrical connections on the control unit simultaneously. > Make sure that no computer viruses are transferred to the control unit by an external data medium (USB stick). Hygiene and maintenance before using for the first time > Sterilize motor with cable and universal support prior to every use. > Clean and disinfect the irrigant support in the thermo washer disinfector. Improper use In addition to unauthorized assembly, installation, modification of or repairs to the control unit, motor with cable, dental handpieces and non-compliance with our instructions, improper use will void the warranty and release us from all other claims. 13

Safety notes – Control unit The control unit is classed as “conventional equipment” (closed equipment without protection against the ingress of water).

Use the control unit in the WS-75 und WI-75 (20:1) ratios exclusively with the contra-angle handpieces approved by W&H. Use of other contra-angle handpieces may result in deviation from the indicated torque. The user alone is therefore responsible for the above. The manufacturer does not accept any liability.

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.

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Safety notes – Control unit Mains cable / Power switch > Only use the mains cable supplied. > Plug the mains cable only into a earthed power socket. > Set up the control unit so the power switch is easily accessible. Disconnect the control unit from the power supply in case of danger. > Turn off the control unit at the power switch. > Pull the power plug out of the socket.

Rotational energy Fast deceleration of the bur can, at times, cause the selected torque to be temporarily exceeded, compared to the value set, as a result of the rotational energy stored in the drive system. Observe the manufacturer’s speed and torque specifications for retaining screws for superstructures. Adjusting these retaining screws with an electric motor presents a potential risk as described above.

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Safety notes – Control unit and motor Danger zones M and G The control unit 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 control unit 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 disinfectants, 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.

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Safety notes – Control unit, motor, foot control Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if patients and users have an implanted device before using the product and test the possible applications. > Assess the risks and benefits. > Keep the product away from implanted devices. > Do not place the motor on the patient’s body. > Take appropriate emergency precautions and take immediate action on any signs of changes to health. > Symptoms such as increased heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD.

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Safety notes – Foot control S-NW / S-N2 Follow the directions and safety notes in the Instructions for Use of the foot control.

AP

The foot control is approved as per IEC 60601-1 / ANSI/AAMI ES 60601-1 for use in zone M (AP).

> Note that when using or setting low speeds, the operation or run-down of rotary instruments is more difficult to detect. > The ESD spring contact on the bottom of the foot control must be in contact with the ground during operation.

ESD is the abbreviation for “electrostatic discharge”.

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Safety notes – Foot control S-NW Disposable batteries > Replace the disposable batteries at the first prompt (battery icon on display). > Replace batteries outside zone M only. > Use only high-quality disposable alkaline AA / Mignon / LR6 / 1,5 V batteries. Risk of explosion if the wrong type of battery is used. > Do not mix new, old or different types of disposable batteries. > Do not use rechargeable batteries. > When inserting disposable batteries make sure that they are correctly oriented. > Always keep spare batteries on hand. > Dispose of faulty or flat batteries immediately and correctly via recycling systems. Do not dispose of batteries in domestic waste. Disposable batteries may cause damage due to leakage or corrosion. > Remove the disposable batteries if you are not going to use the foot control for a longer period.

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Safety notes – Dental handpieces > Follow the directions and safety notes in the Instructions for Use of the dental handpieces. > Use only dental handpieces compatible with an ISO 3964 (DIN 13940) coupling system. > Follow the directions of the manufacturer of dental handpieces with reference to transmission ratio, maximum speed and maximum torque. > Connect the dental handpiece only if the motor is stopped. > Turn off the dental handpiece immediately in the event of failure in the coolant supply. > Check the dental handpiece for damage and loose parts before every use. > Do not activate the chuck mechanism of the dental handpiece during operation or slowing down. > Avoid overheating at the treatment site.

Rotary instruments > Use only rotary instruments in good condition and note the direction of rotation of the instrument. Observe the manufacturer's instructions. > Only insert the rotary instrument when the dental handpiece is stationary. > Never touch a rotary instrument that is still rotating. > Do not activate the chuck mechanism of the dental handpiece during operation. This leads to detachment of the rotary instrument and/or overheating of the dental handpiece.

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