Implantmed SI-923 and SI-915 Instructions For Use Rev 008

Contents Symbols... 4 1. Introduction... 8 2. Unpacking... 10 3. Scope of delivery... 11 4. Safety notes...12 5. Description...17 of front panel...17 of rear panel... 18 of foot control... 19 6. Start-up... 20 7. Control unit...21 8. Control unit operation... 22 Changing program (P1 – P5)... 22 Changing speed (P1 – P3)... 23 Changing torque (P4 – P5)... 24 Changing coolant volume (P1 – P5)... 25 9. Operation... 26 10. Restoring factory settings... 28 11. Thread cutter function (chip breaker mode)... 29 12. Error messages... 30

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Contents 13. 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 14. Servicing... 43 15. Accessories, consumables, spare parts and other recommended medical devices by W&H... 45 16. Technical data... 47 17. Data on electromagnetic compatibility according to IEC/EN 60601-1-2... 49 18. Disposal... 52 W&H course certificate... 53 Explanation of warranty terms... 57 Authorized W&H service partners... 58

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Symbols

4

WARNING! (if persons could be injured)

Sterilizable up to the stated temperature

Consult Instructions for Use

ATTENTION! (if property could be damaged)

CE marking with identification number of the Notified Body

Do not dispose of with domestic waste

General explanations, without risk to persons or property

Manufacturer

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

Medical Device

Date of manufacture

Serial number

Thermo washer disinfectable

Catalogue number

XXXX

Symbols Follow Instructions for Use

Power consumption of the control unit

Supply current

Class II equipment

Electric fuse

Frequency of the alternating current

Foot control

Earth

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 ES606011:2005/A2:2021, CAN/ CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 606011:14/A2:22, IEC 80601-260:2019. 25UX – Control No.

25UX

Off

Supply voltage of the control unit

On

Alternating current

5

Symbols Revolutions per minute (= rpm)

+70 °C (+158°F) Max.

Temperature limitation

-40 °C (-40°F) Min.

This way up

80 %

Humidity limitation

8%

Fragile, handle with care

Keep dry

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

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Data structure in accordance with Health Industry Bar Code Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard

Caution! According to 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.

Symbols Batch code

Use by

Latex-free

Not for re-use

Do not use when package is damaged

Sterilization with ethylene oxide

Do not resterilize

Keep away from heat

Single sterile barrier system

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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 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 medical device. We have based our developmed 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 compliance with the following instructions is ensured: > > > >

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 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 control unit invalidates all claims under warranty and any other claims. Improper use, unauthorized assembly, modification or repair to the medical device, non-compliance with our instructions or the use of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any 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 Lift out the insert with the control unit. Remove the mains cable, irrigant support, universal support 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.

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3. Scope of delivery SI-923 (230 V) 30286000/30286001

Control unit

SI-915 (120 V) 30287000/30287001

REF 07721800

Universal support

X

REF 04005900

Irrigant support

X

Mains cable country-specific

X

Optional included in set REF 04363600 REF 30185000 REF 30285000

Irrigation tubing set 2.2 m (6 pcs, disposable) EM-19 motor without electrical contacts with 1.8 m cable Foot control S-N2

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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 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 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 > Use only original W&H fuses > Never touch the patient and the electrical contacts on the control unit simultaneously.

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

Use the control unit in P4 and P5 programs exclusively with the surgical 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 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 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. 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. Note that when using or setting low speeds, the operation or run-down of rotary instruments is more difficult to detect.

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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.

Follow the directions and safety notes in the Instructions for Use of the foot control, the elctric motors and the transmission handpieces.

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Safety notes Coolant supply The medical device 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. > Only use an irrigation tubing set approved by W&H or accessories approved by W&H. Irrigation tubing set > 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. Hygiene and maintenance prior to initial use > Clean and disinfect the control unit, the universal support and the irrigant support. > Sterilize the universal support.

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5. Description

of front panel

Program buttons

Pump cover Display

P1

P2

P3

P4

Irrigant support locator

P5

Pump cover OPEN Connection for motor

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Description

of rear panel

Irrigant support locator

Connection for foot control

Connection for mains cable Fuse holder with 2 fuses (2 x 250 V - T1.6 AH)

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Power switch ON / OFF

Description

of foot control Locator attach / detach

ORANGE Change program Programs 1 to 4 Program 5 (torque 20 – 60 Ncm)

GREEN Pump ON / OFF

YELLOW Change motor direction forward / reverse operation mode

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

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6. Start-up

General

Place the medical device on a flat level surface. Ensure that the medical device can be disconnected easily from the power supply.  Connect the mains cable and foot control. Pay attention to the positioning!

 Attach the universal support and lock it.

 Connect motor cable. Pay attention to the positioning!

 Insert/remove the irrigation tubing. Pay attention to the correct order. > Open the pump cover (a).

 Insert the irrigant support. Pay attention to the positioning! (maximum load capacity 1.5 kg) 20

> Insert/remove the irrigation tubing (b, c, d). > Close the pump cover (e).