Meg-Engine III SI-915 and SI-923 Instructions for Use June 2019

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............................................................................................................................................................................................... 22 of front panel........................................................................................................................................................................................ 22 of rear panel......................................................................................................................................................................................... 23 of foot control...................................................................................................................................................................................... 24 of motor with cable.............................................................................................................................................................................. 25 7. Start-up...................................................................................................................................................................................................... 26 8. Control unit ............................................................................................................................................................................................... 27 9. Control unit operation.............................................................................................................................................................................. 28 changing program (P1 – P5).............................................................................................................................................................. 28 change speed (P1 – P3)..................................................................................................................................................................... 29 change torque (P4 – P5)..................................................................................................................................................................... 30 change coolant volume (P1 – P5)...................................................................................................................................................... 31 10. Operation................................................................................................................................................................................................ 32 11. Restoring factory settings.................................................................................................................................................................... 34 12. Thread cutter function (chip breaker mode)....................................................................................................................................... 37 13. Error messages....................................................................................................................................................................................... 38 2

Contents 14. Hygiene and maintenance.................................................................................................................................................................... 39 General notes....................................................................................................................................................................................... 39 Limitations on processing................................................................................................................................................................... 40 Initial treatment at the point of use................................................................................................................................................... 41 Manual cleaning................................................................................................................................................................................... 42 Manual disinfection............................................................................................................................................................................. 43 Automated cleaning and disinfection................................................................................................................................................ 44 Drying................................................................................................................................................................................................... 45 Inspection, maintenance and testing................................................................................................................................................ 46 Packaging............................................................................................................................................................................................. 47 Sterilization.......................................................................................................................................................................................... 48 Storage................................................................................................................................................................................................. 49 15. Servicing................................................................................................................................................................................................. 50 16. W&H accessories and spare parts ....................................................................................................................................................... 52 17. Technical data......................................................................................................................................................................................... 54 18. Disposal.................................................................................................................................................................................................. 56 W&H course certificate................................................................................................................................................................................ 57 Explanation of warranty terms.....................................................................................................................................................................61 Authorized W&H service partners............................................................................................................................................................... 62 Manufacturer’s declaration......................................................................................................................................................................... 64 3

Symbols WARNING! (if persons could be injured)

in the Instructions for Use

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 Follow Instructions for Use

Class II equipment

Consult Instructions for Use

Foot control

Date of manufacture

On / Off

Do not dispose of with domestic waste

Electric fuse

Data Matrix code for product information including UDI (Unique Device Identification) CE marking XXXX with identification number of the Notified Body

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

MEDICAL – General medical equipment as to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES 60601-1:2005, 25UX 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.

on the control unit Catalogue number Serial number Supply voltage of the unit Alternating current Electric power consumption of the unit Supply current Frequency of the alternating current Revolutions per minute (= rpm) 5

Symbols CE marking XXXX with identification number of the Notified Body Do not dispose of with domestic waste Data Matrix code for product information including UDI (Unique Device Identification) UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements

Catalogue number Serial number Date of manufacture Category AP equipment AP

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on the foot control

Symbols CE marking XXXX with identification number of the Notified Body This way up Fragile, handle with care Keep dry »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

on the packaging Data Matrix code for product information including UDI (Unique Device Identification) Data structure in accordance with Health Industry Bar Code

Temperature limitation +70°C(+158°F)Max.

-40 °C (-40°F) Min.

80 % 8 %

Humidity, limitation

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 marking XXXX with identification number of the Notified Body Batch code

Not for re-use Use by

on the irrigation tubing set Latex-free 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.

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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. 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. 9

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 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 62/63). > 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. 10

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 device 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. HF communication 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. 11

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

Control unit

REF 436360

Irrigation tubing set 2.2 m (3 pcs, disposable)

REF 30032004

Contra-angle handpiece WS-75 LG

REF 30185004

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

REF 30285000

Foot control S-N2

REF 07721800

Universal support

REF 04005900

Irrigant support

Mains cable country-specific

SI-923 (230V) 30286004

SI-915 (120V) 30287004

X

X

X

X X X X

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5. Safety notes

Control unit / Motor

> Before using the medical device 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 control units or instruments fail.

The medical device 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 > Use only original W&H fuses > Never touch the patient and the electrical connections on the control unit simultaneously.

Control unit

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

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 defibrillators (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 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).

Foot control S-N2

>> 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 The medical device is designed for use with physiological saline solution.

Coolant supply

>> 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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Safety notes Transmission instrument >> Follow the directions and safety notes in the Instructions for Use of the transmission instrument. >> Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturer approved transmission instruments. >> Follow the directions of the manufacturer of transmission instrument with reference to transmission ratio, maximum speed and maximum torque. 20

Safety notes Hygiene and maintenance prior to initial use >> Clean and disinfect the control unit, the motor with cable, the universal support and the irrigant support. >> Sterilize the motor with cable and the universal support. Test run Do not hold the motor with transmission instrument at eye level. >> Connect the transmission instrumente to the motor. Point the transmission instrument with the head facing downwards. >> Operate the motor with the foot control. >> In the event of operating malfunction (e.g. vibrations, unusual noises or overheating), stop the motor immediately and contact an authorized W&H service partner. 21

6. Description Program buttons P1 P2 P3 P4 P5

Display

of front panel Pump cover Irrigant support locator

Pump cover OPEN Connection for motor 22

Description Irrigant support locator

of rear panel

Connection for foot control

Connection for mains cable

Fuse holder with 2 fuses REF 06352200 (2 x 250 V - T1.6 AH)

Power switch ON / OFF

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Description

Locator attach / detach

GREEN Pump ON / OFF GREY Start motor (pedal) VARIABLE or ON / OFF (Factory setting = variable) 24

of foot control ORANGE Change program Programs 1 to 4 Program 5 (torque 20 – 60 Ncm) YELLOW Change motor direction forward / reverse operation mode

Description The motor with cable must not be disassembled. The motor with cable must not be oiled (pre-oiled for entire service life).

of motor with cable

The motor with cable is a type B applied part (not suitable for intracardiac application). Temperature information Temperature of the motor on the operator side: max. 55 °C (131°F) 25

7. Start-up Always 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!

General  Attach the universal support and lock it.

 Connect motor cable. Pay attention to the positioning!  Insert the irrigant support. Pay attention to the positioning! (maximum load capacity 1.5 kg) 26

 Insert/remove the irrigation tubing. Pay attention to the correct order. > Open the pump cover (a). > Insert/remove the irrigation tubing (b, c, d). > Close the pump cover (e).

8. Control unit

Switch on control unit  Connect the control unit to the power supply.

 Switch on the control unit at the power switch.

Switch on / switch off Switch off control unit  Switch off the control unit at the power switch.  Disconnect the control unit from the power supply.

Always make sure that the LED displays on the buttons and the display itself are all on when switching on the medical device.

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9. Control unit operation

changing program (P1 – P5)

Activate the desired program (P1 – P5) by pressing the corresponding program button. During selection an audible signal can be heard and the Program button lights up. The selected program appears on the display with the adjusted range in rpm, e.g. for P1:

Pump function

rpm

ON / OFF

Display settings >> P1 – P3 speed >> P4 – P5 torque

Ncm rpm

Display settings >> P4 – P5 torque in Ncm >> P1 – P3 speed in rpm

Error messages >> Motor temperature too high >> Motor push-in connection 28

Control unit operation Pressing and holding PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased.

change speed (P1 – P3)

 Press program button (P1–P3)  Increase speed  Decrease speed At 40,000 rpm the accuracy of the speed set is ± 10%. 29

Control unit operation

change torque (P4 – P5)

Program P4: Program P5:

range 5 – 70 Ncm, intermediate stage 32 Ncm. range 20 – 60 Ncm.

Pressing and holding PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased. A longer confirmation signal is heard on changing from 5 to 70 Ncm (20 to 60) and 70 to 5 Ncm (60 to 20).

The motor switches off automatically when the set torque is reached in forward and reverse operation modes.

 Press the program button (P4 or P5)  P4: increase torque in 5-Ncm steps P5: increase torque in 10-Ncm steps  P4: decrease torque in 5-Ncm steps P5: decrease torque in 10-Ncm steps

The accuracy of the set torque in the 20 – 50 Ncm range for the W&H WI-75 E/KM contra-angle handpiece is ± 10%. Greater deviations may be encountered with other instruments. 30

Control unit operation

change coolant volume (P1 – P5)

Factory setting 100 % Range 65 %, 80 % and 100 %. Press and hold the PLUS / MINUS button to continuously increase or decrease the values.

Press and hold program button P2 during this procedure.  Press and hold P2 for approx. 4 seconds (the set coolant volume is shown)  Continue to press P2 and press PLUS to increase the flow rate  Continue to press P2 and press MINUS to decrease the flow rate After adjusting, program button P2 is illuminated and active.

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10. Operation

foot control

Change program Press the ORANGE button to select programs 1 – 4 in ascending order. In program 5 switch the torque steps from 20 – 60 Ncm. The motor direction is automatically set to forward operation every time the program is changed.

When changing from program 4 to program 1 and in program 5 from 60 Ncm to 20 Ncm, a longer acknowledgment signal sounds (risk of injury).

Pump ON / OFF Only when the motor is at complete standstill can the pump be switched on or off by pressing the GREEN button of the foot control. If the pump function is activated, the pump symbol is shown on the display.

Reverse operation Press the YELLOW button to change from forward operation to reverse operation. On selecting reverse operation, an audible signal can be heard and the selected program button flashes. Before the motor starts in reverse operation, 3 audible warning signals are given.

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Operation To change from VARIABLE to ON / OFF Keep program button P3 depressed throughout this procedure.  Keep P3 depressed for approx. 4 seconds

foot control

 Continue to keep P3 depressed and simultaneously press the PLUS and MINUS buttons

 Continue to keep P3 depressed and adjust the setting. 01 = VARIABLE (factory setting) – press PLUS button 00 = ON/OFF – press MINUS button After adjusting, program button P3 is illuminated and active. 33

11. Restoring factory settings The factory setting always starts with program 1 (P1).  Switch off the control unit  Press and hold P1 and simultaneously switch on the control unit  Press and hold P1 until the display shows the setting »DE FAU« 34

Factory settings Transmission Speed rpm Setting range rpm Motor direction of rotation Pump Torque Ncm

P1 1:1 35,000 300 – 40,000 forward on 100 %

P2 20:1 1,200 15 – 2,000 forward on 100 %

(P1 – P3) P3 20:1 800 15 – 2,000 forward on 100 % 35

Factory settings

P4 forward

Transmission Speed rpm Motor direction of rotation Pump Torque Ncm Setting range Ncm Intermediate stage Ncm 36

20:1 15 forward on 20 5 – 70 32

P4 reverse 20:1 30 reverse off 60 5 – 70 32

P5 forward 20:1 20 forward on 20 20 – 60 –

(P4 – P5) P5 reverse 20:1 20 reverse on 20 20 – 60 –

12. Thread cutter function (chip breaker mode) When the thread cutter function (P5) is activated, the speed in both forward and reverse operation modes is 20 rpm and can no longer be changed. When the motor button (grey) on the foot control is pressed, the thread cutter rotates inwards until the set torque is reached. The control unit automatically switches to reverse operation when the set torque is reached. Disengaging and then re-engaging the motor button will switch the control unit back to forward operation. If the thread cutter function is in reverse operation mode, the control unit can also start with the maximum torque.  Press P5 program button.  Use Plus/Minus to increase or decrease the torque. 37

13. Error messages

Error no. Description 00 Electronics overheated – safety shutdown 01 Electronics overloaded 02 Voltage too high 07 Initialization error 09 Foot control error 19 Running time limiter 99 System failure Motor plug-in connection

Solution Switch off device, allow device to cool for at least 10 minutes, re-start Switch off device, allow device to cool for at least 10 minutes, re-start Switch off device, check voltage, re-start Switch off device, re-start, do not actuate foot control and display when switching on Switch off device, check plug contacts of foot control, re-start Switch off device and re-start Switch off device, allow device to cool for at least 10 minutes, re-start Switch off device, check plug contacts, re-start

>> Switch the control unit off and on again. If any of the described problems cannot be corrected by the remedy provided above, the unit will need to be inspected by an authorized W&H service partner. >> Switch the control unit off and on again in case of a total system failure. 38

14. Hygiene and maintenance

General notes

Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization.

>> Wear protective clothing, safety glasses, face mask and gloves.

>> Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying. Cleaning agents and disinfectants >> Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/ or disinfectants. >> Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic. >> It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant. >> Use disinfectants which have been tested and found effective by the Verbund für Angewandte Hygiene e.V. (VAH = Association for Applied Hygiene), the Österreichisch Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). >> The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available. 39

Hygiene and maintenance

Limitations on processing

The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. >> Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner. Processing cycles >> We recommend a regular service for the W&H motor with cable after 500 processing cycles or one year. >> We recommend a regular service for the W&H universal support after 250 processing cycles.

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Hygiene and maintenance

Initial treatment at the point of use

Wipe the control unit, the motor with cable, the universal support and the irrigant support with disinfectant.Wipe the entire surface of the instrument with disinfectant.

Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant step after cleaning.

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Hygiene and maintenance

Manual cleaning

Motor with cable / Universal support / Irrigant support >> Do not immerse the motor with cable, the universal support or the irrigant support in liquid disinfectant or in an ultrasonic bath.

Motor with cable / Universal support / Irrigant support >> Clean the motor with cable, the universal support and the irrigant support under running tap water (< 35°C / < 95°F). >> Rinse and brush off all internal and external surfaces. >> Remove any liquid residues using compressed air. Control unit >> Do not immerse the control unit in water or clean under running water. Foot control >> The ESD spring contact on the bottom of the foot control must be cleaned regularly.

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Hygiene and maintenance Motor with cable / Universal support / Irrigant support >> W&H recommends wipe-down disinfection.

Manual disinfection

Evidence of the basic suitability of the motor with cable, the universal support and the irrigant support for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt).

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Hygiene and maintenance

Automated cleaning and disinfection

Motor with cable / Universal support / Irrigant support W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer‑disinfectors, cleaning agents and/or disinfectants. >> The control unit and foot control are not approved for automated cleaning and disinfection.

Evidence of the basic suitability of the motor with cable, the universal support and the irrigant support for effective automated disinfection was provided by an independent test laboratory using the »Miele PG 8582 CD« washer disinfector (Miele & Cie. KG, Gütersloh) and the »Dr. Weigert neodisher® MediClean forte« cleaning agent (Dr. Weigert GmbH & Co. KG, Hamburg) according to ISO 15883. >> Cleaning at 55 °C (131°F) – 5 minutes >> Disinfection at 93 °C (200°F) – 5 minutes

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Hygiene and maintenance

Drying

Motor with cable / Universal support / Irrigant support >> Ensure that the motor with cable, the universal support and the irrigant support are completely dry internally and externally after cleaning and disinfection. >> Remove any liquid residues using compressed air.

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Hygiene and maintenance

Inspection, maintenance and testing

Inspection – Motor with cable / Universal support / Irrigant support >> Check the motor with cable, the universal support and the irrigant support after cleaning and disinfection for damage, visible residual soiling and surface changes. >> Reprocess any motor with cable, universal support and irrigant support that are still soiled. >> Sterilize the motor with cable and the universal support following cleaning and disinfection.

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Hygiene and maintenance

Packaging

Motor with cable / Universal support Wrap the motor with cable and the universal support in sterilization packages that meet the following requirements: >> The sterilization procedure must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >> The sterilization package must be large enough for the sterilization goods. >> The loading sterilization package must not be under tension.

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Hygiene and maintenance Motor with cable / Universal support W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79.

Sterilization

>> Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. >> The program selected must be suitable for the motor with cable and the universal support.

Recommended sterilization cycles >> Steam sterilization (Typ B, N) >> Sterilization time at least 3 minutes at 134°C (273°F), 4 minutes at 132°C (270°F), 30 minutes at 121°C (250°F) >> Maximum sterilization temperature 135 °C (275°F) Evidence of the basic suitability of the motor with cable and the universal support for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)) and the CertoClav MultiControl MC2-S09S273 gravitation sterilizer (CertoClav GmbH, Traun). “Dynamic-air-removal prevacuum cycle” (type B): temperature 134°C (273°F) – 3 minutes* temperature 132°C (270°F) – 4 minutes*/** “Gravity-displacement cycle” (type N): temperature121°C (250°F) – 30 minutes** * EN 13060, EN 285, ISO 17665 ** ANSI/AAMI ST55 , ANSI/AAMI ST79 48

Hygiene and maintenance Motor with cable / Universal support >> Store sterile goods dust-free and dry. >> The shelf life of the sterile goods depends on the storage conditions and type of packaging.

Storage

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15. Servicing Regular checks Regular servicing of function and safety including the accessories is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a qualified organization and must include the following procedures: Control unit >> External visual inspection >> Measurement of device leakage current >> Measurement of patient leakage current >> Visual inspection of internal components on suspicion of safety interference, e.g., mechanical damage of the enclosure or indicators of overheating Foot control >> External visual inspection >> Measurement of device leakage current >> Measurement of ESD capacity >> Visual inspection of the ESD spring contact on the bottom of the foot control (electrostatic discharge) >> Function test with check to see if the maximum speed can be reached The regular inspection must only be performed by an authorized W&H service partner. 50