Implantmed SI-923 and SI-915 Instructions for use Rev 005 Dec 2015

Contents W&H Symbols... 3 – 6 1. Introduction... 7 – 8 2. Electromagnetic compatibility (EMC)...9 3. Unpacking...10 4. Scope of delivery...11 5. Safety notes... 12 – 16 6. Description of front panel... 17 7. Description of rear panel...18 8. Description of foot control...19 9. Description of motor with cable... 20 10. Starting operation – General... 21 11. Switch on / switch off Implantmed... 22 12. Control unit operation... 23 – 26 13. Foot control operation...27 – 28 14. Factory settings... 29 – 31 15. Thread cutter function (chip breaker mode)...32 16. Error messages...33 17. Hygiene and maintenance...34 – 39 18. W&H Accessories... 40 – 41 19. Servicing...42 – 43 20. Technical data...44 – 45 21. Recycling and disposal... 46 Certification of training...47, 49 Explanation of warranty terms...51 Authorized W&H service partners...52 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

For USA and Canada: 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. 3

W&H Symbols Symbols on the control unit Follow instructions for use

Do not dispose of with domestic waste

REF Catalogue number

Consult instructions for use

Foot switch

SN

Serial number

Class II equipment

On / Off

V

Supply voltage of the unit

AC

Alternating current

Date of manufacture

Data matrix code for product identification e.g. for hygiene / maintenance processes

VA

Electric power input of the unit

A

Supply current

Hz

Frequency of the alternating current

Electric fuse

Not suitable for intracardiac application – Type B applied part

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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.)

rpm Revolutions per minute (rpm = min-1 )

W&H Symbols Symbols on the packaging This way up

Temperature limit

Fragile, handle with care

Humidity limitation

Keep away from rain

CE 0297 from manufacturer

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

Der Grüne Punkt Identification mark of Duales System Deutschland AG

RE Y

General symbol for recovery/recyclable 5

Symbols Symbols on the irrigation tubing Sterilization with ethylene oxide

Consult instructions for use

Not for re-use

CE 0481 from manufacturer

Latex-free

Not sterile

Use by

Sterilizable at the stated temperature

Batch ID

Caution, please observe accompanying documents

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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

1. Introduction For your safety and the safety of your patients These instructions 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 that you observe the safety notes on pages 12 to 16. Intended use Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964 (DIN 13.940). The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue. Misuse may damage the Implantmed and hence cause risks and hazards for patients, users and third parties. Qualifications of the user Only suitably qualified medical, technical and specialist trained staff may use the dental surgical unit Implantmed. 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 EU Directive 93/42/EEC has been used as a basis in the design and manufacture of this medical device and it applies to the dental surgical units > Implantmed SI-915 and > Implantmed SI-923 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 Implantmed when it is used in compliance with the following directions: > 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 52). > 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. Unpacking  Lift out the insert with the stand.

 Remove the irrigation tubing.

 Lift out the insert with the foot control.

 Remove the carton with motor, accessories and instruments (optional).

 Lift out the insert with the control unit.

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  SI-923 REF 16929000 (230 V)  SI-915 REF 16929001 (115 V) Mains cable  REF 01343700 (EU)  REF 02821400 (USA, CAN, J) / REF 03212700 (UK, IRL) / REF 02909300 (AUS, NZ) / REF 04280600 (CH) / REF 05901800 (DK)  Foot control S-N1 REF 06202400  Handle for foot control REF 04653500  Motor with 1.8 m cable REF 06631600 incl. 5 clips REF 04019000  Motor support REF 06177800  Stand REF 04005900  Locking pins REF 04006800 (2 pcs)  Irrigation tubing REF 436360 (3 pcs, disposable)

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5. Safety notes Please observe the following instructions under all circumstances > Before using the Implantmed for the first time, store it at room temperature for 24 hours. > Only fit the straight and contra-angle handpieces when the motor is at a complete standstill. > Never touch rotary instruments that are still rotating. > Never touch the chuck mechanism of straight and contra-angle handpieces during operation or while they are still running down. > Make sure that the operation can be completed safely even if a device or instrument malfunctions. > Always ensure correct operating conditions and that sufficient and adequate cooling is delivered. > Avoid overheating at the treatment site. > Check the Implantmed, the straight or contra-angle handpiece and the motor with cable for damage and loose parts each time before using. Correct any faults or refer to an authorized W&H service partner (see page 52). Do not operate the Implantmed if it is damaged. > When changing the fuse, disconnect the unit from the power supply and only use W&H original fuses. > Perform a test run prior to each treatment. > Never touch the patient and the connections for the foot control simultaneously. > Check the parameter settings every time the device is restarted. > The ESD spring contact on the underside of the foot control must touch the floor during operation. Use only suitable and serviceable tools Ensure that you comply with the manufacturer’s instructions for surgical straight and contra-angle handpieces with respect to maximum speed, maximum torque, forward and reverse movement.

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Inappropriate use Improper use, in addition to incorrect assembly, installation, modification or repairs of the Implantmed or failure to comply with our instructions invalidates all claims under warranty and any other claims.

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 patients and users have an implanted device before using the product and consider the applications. > Weigh the risks and benefits > Keep the product away from implanted devices. > 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 control unit and the motor with cable are not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide. Implantmed is not suitable for use in oxygen-enriched atmospheres. Foot control is in accordance with IEC 60601-1/ANSI/AAMI ES 60601-1 approved for use in zone M (AP). 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 anaesthesia or medical antiseptics and antibacterial soaps; such atmospheres are limited and only occur very briefly. Please note that at low speeds, it is more difficult to determine that the motor is running. Control unit The control unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water). When using the transmission settings 20:1, Implantmed must only be employed with the following W&Happroved surgical contra-angle handpieces: WS-75 E/KM, WS-75 LED G, WI-75 E/KM and WI-75 LED G. Use of other contra-angle handpieces may result in deviation from the indicated torques and is the user’s responsibility. The specified transmission ratios for the programs 1 to 5 must always be taken into consideration. 14

Safety notes Mains cable Only use the mains cable supplied. Only connect to a grounded socket outlet. Set up the device so that the power switch is easily accessible. In dangerous situations, the device can be disconnected from the power supply using the power switch or power cable. The power switch can also be used to safely stop the device. Power failure In the event of a power failure, if the Implantmed 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. Intermittent operating mode S3 (3 min/10 min) The Implantmed is designed for intermittent operating mode S3 with an operating time of 3 minutes and an idle time of 10 minutes.If the operating mode specified is observed no overheating of the system and therefore no injury to the patient, user or third persons arises. The responsibility for the use and timely shutdown of the system lies with the user. 15

Safety notes Coolant The Implantmed is designed for use with physiological saline solution. Use only suitable irrigation fluids and follow the manufacturer’s medical data and instructions. Use the W&H irrigation tubing set or accessories approved by W&H. You can purchase the coolant bottle or the coolant bag at a drugstore. Sterility of irrigation tubing set Sterile irrigation tubing sets are supplied with the equipment. The irrigation tubing is a disposable article and must be discarded after each treatment. Please note the expiry date and the relevant regulations for disposal of irrigation tubing. Only use disposable irrigation tubing with undamaged packaging.

Rotational energy As a result of the rotational energy stored in the drive system – compared to the value set – fast deceleration of the bur can cause the selected torque to be significantly overloaded, at times. Observe the individual manufacturer’s instructions for use when adjusting superstructure screws. We would point out that adjusting these screws with an electric motor presents a potential risk as described above.

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6. Description of front panel Program buttons

Pump arm Display

P1

P2

P3

P4

Stand holder

P5

Pump arm OPEN Motor connection socket

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7. Description of rear panel

Stand holder

Connecting socket for foot control

Power socket

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

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Power switch ON / OFF

8. Description of foot control Handle attach / detach

ORANGE Change program Programs 1 to 4 and torque steps 20 – 60 Ncm in program 5

GREEN Pump ON / OFF

YELLOW Change motor direction forward / reverse drive

GREY Start motor (pedal) VARIABLE or ON / OFF (Factory setting = variable)

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9. Description of motor with cable The motor with cable must not be disassembled. The motor with cable must not be oiled (lubricated for life).

To prevent the instrument on the motor attachment from turning during transmission of high torques, the locking pin supplied can be pushed into the designated hole (see illustration). The locking pin can only be used in combination with straight and contra-angle handpieces that have corresponding holes. The motor with cable is defined as a type B applied part. Temperature information: Applied part – dental instrument with cooling: max. 40 °C Applied part motor: max. 55 °C

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