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W&H Implantmed Plus SI-1010, Инструкция по эксплуатации

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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) for treatment of dental hard tissue.

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.

Содержание Implantmed Plus SI-1010

Страница 1: ...Instructions for Use Edition USA SI 1010 SI 1015 SI 1023 ...

Страница 2: ...4 Safety notes 12 5 Description 17 of front panel 17 of rear panel 18 of foot control S N2 S NW 19 6 Start up 21 7 Starting operation 23 8 Control unit operation 24 Main menu 24 Menue Navigation 27 Documentation with USB stick 33 ioDent platform 35 Beacon 37 9 Error messages 38 ...

Страница 3: ...ed cleaning and disinfection 46 Drying 47 Inspection maintenance and testing 48 Packaging 49 Sterilization 50 Storage 52 11 Servicing 53 12 W H accessories and spare parts 55 13 Technical data 58 14 Data on electromagnetic compatibility according to IEC EN 60601 1 2 60 15 Disposal 63 W H course certificate 64 Explanation of warranty terms 67 Authorized W H service partners 68 ...

Страница 4: ... marking with identification number of the Notified Body XXXX Manufacturer Consult Instructions for Use Catalogue number Serial number Do not dispose of with domestic waste DataMatrix code for product information including UDI Unique Device Identification Date of manufacture Symbols Sterilizable up to the stated temperature Thermo washer disinfectable ...

Страница 5: ...control unit Supply current Frequency of the alternating current MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 R 2012 A1 2012 C1 2009 R 2012 A2 2010 R 2012 ANSI AAMI ES60601 1 2005 A2 2021 CAN CSA C22 2 No 60601 1 14 CAN CSA C22 2 No 60601 1 14 A2 22 IEC 80601 2 60 2019 25UX Control No 25UX ...

Страница 6: ... of recyclable transport and outer packaging of paper and cardboard 40 C 40 F Min 70 C 158 F Max 8 80 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 Data struct...

Страница 7: ...7 Symbols Sterilization with ethylene oxide Batch code Not for re use Latex free Use by Do not resterilize Do not use when package is damaged Keep away from heat Single sterile barrier system ...

Страница 8: ...chanical 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 for treatment of dental hard tissue 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 technica...

Страница 9: ...tion 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 ...

Страница 10: ...accessories 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 ...

Страница 11: ...e X REF 07721800 Universal support X REF 04005900 Irrigant support X Mains cable country specific X Optional included in set REF 3028100x EM 19 LC motor with electrical contacts and 1 8 m or 3 5 m cable REF 30185000 EM 19 motor without electrical contacts with 1 8 m cable REF 30264000 Foot control S NW REF 30285000 Foot control S N2 REF 07759700 SPI dongle ...

Страница 12: ...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 appro...

Страница 13: ...t without protection against the ingress of water Use the WS 75 WI 75 and SZ 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 contro...

Страница 14: ...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 o...

Страница 15: ...r 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 ...

Страница 16: ... 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...

Страница 17: ...17 5 Description Connection for motor Display touchscreen Pump cover OPEN Pump cover Irrigant support locator of front panel ...

Страница 18: ...18 Description Connection for foot control Fuse holder with 2 fuses 2 x 250 V T1 6 AH Connection for mains cable Irrigant support locator USB USB Power switch ON OFF of rear panel ...

Страница 19: ...ge program Change application Locator attach detach GREEN Pump ON OFF GREY Start motor pedal VARIABLE or ON OFF Factory setting variable YELLOW Change motor direction Forward operation reverse operation of foot control S N2 S NW ...

Страница 20: ...al sounds risk of injury GREEN pump ON OFF Only when the motor is stationary can the pump be switched on or off by pressing the GREEN button of the foot control YELLOW change motor direction Forward operation reverse operation Press the YELLOW button to change from forward operation to reverse operation A signal sounds on selection and the Forward reverse operation mode symbol flashes Before the m...

Страница 21: ... support Pay attention to the positioning Maximum load capacity 1 5 kg Place the medical device on a flat level surface Ensure that the medical device can be disconnected from the power supply at any time S N2 S NW Attach the universal support and lock it Insert the irrigation tubing Open the pump cover a b Insert the irrigation tubing c Close the pump cover d ...

Страница 22: ... unit Plug the mains cable into an earthed power socket Switch on the control unit at the power switch Pull the power plug out of the socket Switching off the control unit Switch off the control unit at the power switch Start up ...

Страница 23: ...may scratch or damage the surface Setting up Implantmed Switch on your control unit and follow the directions of the setup wizard The set up wizard guides you through the various set up stages up to the main menu Language selection Set Up Medical Device Customized Create a user Standard Default settings Setup wizard ...

Страница 24: ...rites Set program Documentation Wi Fi Pairing Set speed torque Setup Foot control Forward reverse operation mode Progress display mode Set coolant volume Programs Tooth position 8 Control unit operation Main menu ...

Страница 25: ... Adjust factory setting of drill protocol groups Create drill protocol Copy Rename Activate Delete Select drill protocol group An activated drill protocol cannot be deleted My favorites Control unit operation ...

Страница 26: ...ange 5 70 Ncm with SZ 75 only The motor switches off automatically when the set torque is reached in forward and reverse operation modes The accuracy of the set torque in the 20 50 Ncm range for the W H WI 75 WS 75 and SZ 75 contra angle handpieces is 10 Greater deviations may be encountered with other contra angle handpieces Control unit operation Documentation DOCU only appears once the document...

Страница 27: ...27 Control unit operation Menue Navigation ...

Страница 28: ...Rename Activate Delete Pairing S NW Foot control Variable ON OFF Set screen lock Activating deactivating screen lock Screen lock Interval Interval Select time SOUND Activating deactivating Language Select language System Add user Torque curve LED Activating deactivating LED Fade out time Select time ...

Страница 29: ... Motor control unit Control unit operation System check Test run Dental numbering system Select dental numbering system FDI UNS FDI Féderation Dentaire Internationale International dental numbering system UNS Universal Numbering System American dental numbering system Osstell Switch between selected tooth positions green Selected tooth position black Wi Fi dongle ...

Страница 30: ...tware update Reset Wi Fi pairing Control unit operation Reset Restore factory settings Restart Control unit restarts automatically Import user settings Export user settings Beacon Foot control Beacon Pairing ...

Страница 31: ... save red error message work cannot be continued orange error message work can be continued Favorite selected red replace batteries Foot control S NW Foot control S N2 Drill function Drill function Implantatinsertion Drill function Thread cutter function Implant stability quotient measurement ...

Страница 32: ... reached The control unit automatically switches to reverse operation when the set torque is reached Disengaging and then re engaging the pedal 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 Control unit operation Factory settings ...

Страница 33: ...or each program A USB stick is required to save the documentation Never remove the USB stick while the motor is running Never remove the USB stick during the measurement Record documentation Connect USB stick Icon appears Enter ID Enter date Select tooth quadrant Select tooth Confirm selection Documentation starts when the motor starts Control unit operation Documentation with USB stick ...

Страница 34: ... a PDF file are saved on the USB stick The text file can be opened in Microsoft Excel for editing The pdf file can be opened in Adobe Reader Microsoft Excel is a registered trademark of the Microsoft Corporation in the United States of America and or other countries Adobe Reader is a registered trademark of Adobe Systems Incorporated in the United States of America and or other countries Documenta...

Страница 35: ...d correctness Establishing a connection to the ioDent platform Insert the ioDent Wi Fi dongle The connection is established The icon appears If the icon is green The documentation is active If the icon is grey The system is connected If the icon is yellow There is a connection problem When the motor stops a diagram appears which is automatically saved to the ioDent platform Control unit operation ...

Страница 36: ...additional items to the IT Network disconnecting items from the IT Network update of equipment connected to the IT Network and upgrade of equipment connected to the IT Network Not paired device Paired device Device IP address 192 168 10 1 192 168 10 x from Gateway DHCP Server Device communication port 443 TLS SSL 443 TLS SSL Device subnet 255 255 255 0 255 255 255 0 Device hostname Implantmed Impl...

Страница 37: ...ng standard Only possible in the ISQ program All Beacons connect to the medical device automatically Beacon pairing using the serial number Enter the serial number in the system settings Only the Beacon with the entered serial number can connect to the medical device Deleting Beacon pairing Enter 0 to delete the stored serial number Control unit operation Beacon ...

Страница 38: ...r at least 10 minutes WARNING STORAGE DEVICE Insufficient memory available Unknown file system The write protection is active Unknown storage device Plug in a USB stick with sufficient memory WARNING OVERHEATING Switch off the control unit Allow the control unit to cool for at least 10 minutes Switch on the control unit The error message disappears when it is clocked or when the pedal grey on the ...

Страница 39: ...AIRED System is not paired with the gateway Please wait and if it occurs repeatedly contact an authorised service partner WARNING OSSTELL Remove the ISQ module and then assembly or Connect probe Remove probe from a source of electromagnetic interference Maintain a distance between the probe and the SmartPeg 3 5 mm or Switch the control unit off and back on again WARNING Wi Fi CONNECTION Press the ...

Страница 40: ... the ioDent platform WARNING TIME SYNCHRONISATION Restart the gateway Insert the ioDent Wi Fi dongle again WARNING SYSTEM MONITORING Release the pedal grey on the foot control and press it again If the error occurs again restart the device WARNING IMPLANT DOCUMENTATION Maximum number of implants 8 for the active documentation has been reached WARNING DOCUMENTATION ACTIVE Finish the current documen...

Страница 41: ... 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 Food and Drug Admi...

Страница 42: ...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 universal support after 250 processing cycles Limitations on processing ...

Страница 43: ...e cloth moistened with a neutral detergent for medical devices according to the manufacturer s instruction Use a clean cloth moistened with disinfectant and wipe all surfaces Make sure all surfaces remain visibly wet at room temperature for at least the minimum time specified in the instructions for use supplied by the disinfectant manufacturer Note that the disinfectant used during pre treatment ...

Страница 44: ... Do not immerse the medical device in water or clean it under running water Lightly wipe all external surfaces of the control unit with a soft lint free cloth moistened with a neutral detergent for medical devices Clean surfaces until all visible soil is removed Remove the detergent from all surfaces using a lint free cloth moistened with distilled water deionized water or demineralized water Evid...

Страница 45: ...independent test laboratory using the disinfectant CaviWipes Metrex Control unit W H recommends wipe down disinfection After removing all visible soil use a clean cloth moistened with disinfectant and wipe all surfaces Make sure all surfaces remain visibly wet at room temperature for at least the minimum time specified in the instructions for use supplied by the disinfectant manufacturer Hygiene a...

Страница 46: ...t is not approved for automated cleaning and disinfection Evidence of the basic suitability 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 1...

Страница 47: ...nce Universal support Irrigant support Ensure that the universal support and the irrigant support are completely dry internally and externally after cleaning and disinfection Remove liquid residues using compressed air Drying ...

Страница 48: ...heck the medical device after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess any medical devices and stand that are still soiled Sterilize the universal support following cleaning and disinfection Inspection maintenance and testing ...

Страница 49: ...the following requirements The sterilization package 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 filled sterilization package must not be under tension Packaging ...

Страница 50: ... the warnings provided by the manufacturers of steam sterilizers The program selected must be suitable for the universal support Recommended sterilization procedures Dynamic air removal cycle type B S 132 C 270 F for at least 4 minutes Gravity displacement cycle type N 121 C 250 F for at least 30 minutes Maximum sterilization temperature 135 C 275 F Sterilization ...

Страница 51: ...erilizer W H Sterilization S r l Brusaporto BG and the CertoClav MultiControl MC2 S09S273 steam sterilizer CertoClav GmbH Traun Dynamic air removal cycle 132 C 270 F 4 minutes Gravity displacement cycle 121 C 250 F 30 minutes Minimum drying times Dynamic air removal cycle 132 C 270 F 30 minutes Gravity displacement cycle 121 C 250 F 30 minutes EN 13060 EN 285 ISO 17665 ANSI AAMI ST55 ANSI AAMI ST7...

Страница 52: ...52 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 Hygiene and maintenance Storage ...

Страница 53: ...ction and safety of the medical device is necessary and should be carried out at least once every three years unless shorter intervals are prescribed by law The periodic inspection covers the complete medical device and must only be performed by an authorized service partner ...

Страница 54: ...immediately contact an authorized W H service partner Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has been completely processed before returning it Always return equipment in the original packaging ...

Страница 55: ... parts or accessories approved by W H Suppliers W H partners Link https www wh com 04013500 Cassette 07962790 Transportation case 07721800 Universal support 04005900 Irrigant support 06352200 Fuse 250 V T1 6AH 3028100x EM 19 LC motor with electrical contactsand 1 8 m or 3 5 m cable ...

Страница 56: ...00 Irrigation tubing set 2 2 m 6 pcs 04364100 Irrigation tubing set 3 8 m 6 pcs 30285000 Foot control S N2 30264000 Foot control S NW 04653500 Locator for foot control 30185000 EM 19 motor without electrical contacts and 1 8 m cable 04719400 Irrigation tubing set 2 2 m ...

Страница 57: ...57 W H accessories and spare parts 08026120 ioDent Wi Fi dongle 08026150 ioDent gateway mini ...

Страница 58: ...ol unit SI 1023 SI 1015 SI 1010 Mains voltage 230 V 120 V 100 V Permissible voltage fluctuation 220 240 V 110 130 V 90 110 V Rated current 0 3 0 8 A 0 3 1 6 A 0 3 1 4 A Maximum power consumption 170 VA 140 VA Frequency 50 60 Hz Mains fuse 2 pcs 250 V T1 6 AH Maximum power output 80 W Maximum torque at motor 6 2 Ncm Motor speed range in the rated voltage range 200 40 000 rpm Coolant flow rate at 10...

Страница 59: ... m above sea level Class II medical electrical device protective earth conductor used for functional earth connection only Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Device according to IEC 60601 1 ANSI AAMI ES 60601 1 ...

Страница 60: ...user should assure that this medical device is set up and used in an environment of the specified type and or in accordance with the specifications of the manufacturer This medical device uses RF energy only for its internal functions Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment No special precautions are necessary to maintain the ...

Страница 61: ...rts The use of accessories and spare parts not approved by W H can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference 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 sho...

Страница 62: ...discharge 2 kV 4 kV 8 kV 15 kV Radiated RF electromagnetic fields IEC EN 61000 4 3 80 MHz 2 7 GHz 10 V m Proximity fields from RF wireless communications equipment IEC EN 61000 4 3 385 MHz 27 V m 450 MHz 28 V m 710 745 780 MHz 9 V m 810 870 930 MHz 28 V m 1720 1845 1970 2450 MHz 28 V m 5240 5500 5785 MHz 9 V m Electrical fast transients bursts IEC EN 61000 4 4 Mains supply Input and output ports 2...

Страница 63: ...Disposal Ensure that the parts are not contaminated on disposal Follow your local and country specific laws directives standards and guidelines for disposal Medical device Waste electrical equipment Packaging ...

Страница 64: ...e and maintenance and service regular inspections Product name Serial number SN Manufacturer with address Distributor with address Name of the user Date of birth and or personnel number Hospital dental practice department with address Signature of the user The signature confirms that the user has been trained to use the medical device and has understood the content Name of the instructor Date of i...

Страница 65: ...ice regular inspections Product name Serial number SN Manufacturer with address Distributor with address Name of the user Date of birth and or personnel number Hospital dental practice department with address Signature of the user The signature confirms that the user has been trained to use the medical device and has understood the content Name of the instructor Date of instruction Address of the ...

Страница 66: ......

Страница 67: ...ithin a warranty period of 24 months from the date of purchase Accessories and consumables universal support coolant hose irrigant support fuse locator for foot control hose clips mains cable sterilization cassette are not covered by the warranty We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to do so by W H Claims unde...

Страница 68: ...68 Authorized W H service partners Find your nearest authorized W H service partner at http wh com Simply go to the menu option Service for full details Or simply scan the QR code ...

Страница 69: ......

Страница 70: ...Manufacturer W H Dentalwerk Bürmoos GmbH Ignaz Glaser Straße 53 5111 Bürmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com Form Nr 50873 AAE Rev 006 23 09 2022 Subject to alterations ...

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