implantmed SI-1010 Instructions for Use Rev 004 June 2018

Contents Symbols... 4 1. Introduction... 9 2. Electromagnetic compatibility (EMC)... 11 3. Unpacking...12 4. Scope of delivery...13 5. Safety notes...14 6. Description of front panel... 22 of rear panel... 23 of foot control S-N2/S-NW... 24 of motor with cable... 26 7. Start-up... 27 8. Control unit... 28 9. Icons Navigation... 29 Information... 30 Main menu... 31 Programs... 32 Setup... 33 10. Starting operation... 35 11. Control unit operation Main menu... 36 Factory settings... 38 Setup... 44 System... 45 Documentation (DOKU)... 47

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Contents 12. Error messages... 49 13. Hygiene and maintenance General notes... 51 Limitations on processing... 52 Initial treatment at the point of use... 53 Manual cleaning... 54 Manual disinfection... 55 Automated cleaning and disinfection... 56 Drying... 57 Inspection, Maintenance and Testing... 58 Packaging... 59 Sterilization... 60 Storage...61 14. Servicing... 62 15. W&H accessories and spare parts... 64 16. Technical data... 66 17. Disposal... 68 W&H course certificate... 69 Explanation of warranty terms... 73 Authorized W&H service partners...74

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Symbols

4

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

Symbols

on the control unit

Follow Instructions for Use

Class II equipment

Catalogue number

Consult Instructions for Use

Foot control

Serial number

Date of manufacture

On / Off

Supply voltage of the control unit

Do not dispose of with domestic waste

Electric fuse

Alternating current

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

Type B applied part (not suitable for intracardiac application)

Power consumption of the control unit

CE marking 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.)

Supply current Frequency of the alternating current Revolutions per minute (= rpm)

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Symbols

on the foot control

CE marking XXXX with identification number of the Notified Body

Non-ionizing electromagnetic radiation

Catalogue 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

AP

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

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Category AP equipment

Symbols

on the packaging

CE marking 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

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and intends to use or order the use of this medical device.

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Symbols Consult Instructions for Use

CE mark XXXX with identification number of the Notified Body

Batch code

8

on the irrigation tubing set Not for re-use

Latex-free

Use by

Sterilization with ethylene oxide

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and intends to use or order the use of this medical device.

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. 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 medical device 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 W&H Implantmed. We have based our developmed 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. >> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 74). >> 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. In addition to unauthorized assembly, installation, modification of or repairs to the control unit, motor with cable, transmission instrument and non-compliance with our instructions, improper use will void the warranty and release us from all other claims.

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2. Electromagnetic compatibility (EMC) Medical electrical device 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 device.

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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. 12

4. Scope of delivery REF

Description

30288000

Control unit SI-1023 (230 V)

30289000

Control unit SI-1015 (115 V)

30290000

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

30264000

Foot control S-NW

30285000

Foot control S-N2

01343700

Mains cable EU

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 13

5. Safety notes

Control unit / Motor

> 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.

The Implantmed is not approved for operation in potentially explosive atmospheres. Do not twist or kink the motor cable! Do not coil it too tightly! Moisture in the motor with cable may cause a malfunction! (Risk of short circuit)

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Safety notes

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). 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. 15

Safety notes

Control unit / Motor

Mains cable / Power switch >> Only use the mains cable supplied. >> Plug the mains cable only into an earthed power socket. >> Set up the control unit so the power switch and the socket are easily accessible at all times. 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 Deceleration of the bur can, 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 / Motor / Foot control

Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD), can be affected by electric, magnetic and electromagnetic fields. >> Find out if patient and user have implanted systems before using the medical device and consider the application. >> Weigh the risks and benefits. >> Keep the medical device away from implanted systems. >> Do not place the motor on the patient’s body. >> 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.

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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.

The foot control is approved for operation in potentially explosive atmospheres (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

Keep the ORANGE button depressed to switch between the control units Disposable batteries > Replace the disposable batteries at the first prompt (battery icon on display or LED on dongle). > Replace batteries outside explosive atmospheres only. > Pay attention to the battery icon on the display before and after each treatment. > Dispose of faulty or flat batteries immediately and correctly via recycling systems. Do not dispose of batteries in domestic waste. > 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. > Check the O-ring of the battery cover for damage. Replace a faulty or leaking O-ring immediately. > Always keep spare batteries on hand. 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. >> See the safety notes of the battery manufacturer. 19

Safety notes

Coolant supply

The Implantmed is designed for use with physiological saline solution.

>> Always ensure correct operating conditions and that sufficient and adequate coolant is delivered. >> Always provide sufficient coolant and ensure the appropriate suction. >> 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.

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