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Instructions for Use

SI-915 / SI-923

Содержание Implantmed

Страница 1: ...Instructions for Use SI 915 SI 923...

Страница 2: ...foot control 23 of motor with cable 24 7 Start up 25 8 Implantmed 26 9 Control unit operation changing program P1 P5 27 change speed P1 P3 28 change torque P4 P5 29 change coolant volume P1 P5 30 10...

Страница 3: ...cleaning and disinfection 43 Drying 44 Inspection Maintenance and Testing 45 Packaging 46 Sterilization 47 Storage 48 15 Servicing 49 16 W H accessories and spare parts 51 17 Technical data 53 18 Dis...

Страница 4: ...uld be injured ATTENTION if property could be damaged General explanations without risk to persons or property Call customer service Sterilizable up to the stated temperature Thermo washer disinfectab...

Страница 5: ...t information including UDI Unique Device Identification Type B applied part not suitable for intracardiac application Foot control Do not dispose of with domestic waste On Off Consult Instructions fo...

Страница 6: ...k indicates compliance with Canadian and U S requirements Do not dispose of with domestic waste Data Matrix code for product information including UDI Unique Device Identification CE marking with iden...

Страница 7: ...care Keep dry Permitted temperature range Humidity limitation Der Gr ne Punkt The Green Dot trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable tra...

Страница 8: ...ld 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 who intends to use or order the use of this medical dev...

Страница 9: ...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...

Страница 10: ...ications or repairs must only be undertaken by an authorized W H service partner see page 62 The electrical installation at the premises must comply with the regulations laid out in IEC 60364 7 710 In...

Страница 11: ...are 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 interfere...

Страница 12: ...ccessories 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...

Страница 13: ...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 30285000 Foot control S N2 01...

Страница 14: ...ery 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...

Страница 15: ...ely 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 man...

Страница 16: ...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 v...

Страница 17: ...er 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 pa...

Страница 18: ...ion 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...

Страница 19: ...ow 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 t...

Страница 20: ...oupling system and manufacturer approved transmission instruments Follow the directions of the manufacturer of transmission instrument with reference to transmission ratio maximum speed and maximum to...

Страница 21: ...21 6 Description Connection for motor Display Pump cover OPEN Program buttons P1 Pump cover Irrigant support locator P2 P3 P4 P5 of front panel...

Страница 22: ...22 Description Connection for foot control Fuse holder with 2 fuses REF 06352200 2 x 250 V T1 6 AH Connection for mains cable Power switch ON OFF Irrigant support locator of rear panel...

Страница 23: ...tach GREEN Pump ON OFF GREY Start motor pedal VARIABLE or ON OFF Factory setting variable ORANGE Change program Programs 1 to 4 Program 5 torque 20 60 Ncm YELLOW Change motor direction forward reverse...

Страница 24: ...t suitable for intracardiac application Temperature information Temperature of the motor on the operator side max 55 C 131 F The motor with cable must not be disassembled The motor with cable must not...

Страница 25: ...to the positioning maximum load capacity 1 5 kg Attach the universal support and lock it Insert remove the irrigation tubing Pay attention to the correct order Open the pump cover a Insert remove the...

Страница 26: ...from the power supply 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...

Страница 27: ...m appears on the display with the adjusted range in rpm e g for P1 rpm Ncm rpm Display settings P1 P3 speed P4 P5 torque Pump function ON OFF Display settings P4 P5 torque in Ncm P1 P3 speed in rpm Er...

Страница 28: ...holding PLUS MINUS depressed activates the repeat function and the values are continuously increased decreased Press program button P1 P3 Increase speed Decrease speed At 40 000 rpm the accuracy of th...

Страница 29: ...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...

Страница 30: ...lues 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...

Страница 31: ...dgment 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 i...

Страница 32: ...depressed for approx 4 seconds 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...

Страница 33: ...tory settings 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 The factory setting always starts...

Страница 34: ...ettings P1 P2 P3 Transmission 1 1 20 1 20 1 Speed rpm 35 000 1 200 800 Setting range rpm 300 40 000 15 2 000 15 2 000 Motor direction of rotation forward forward forward Pump on on on Torque Ncm 100 1...

Страница 35: ...rward P5 reverse Transmission 20 1 20 1 20 1 20 1 Speed rpm 15 30 20 20 Motor direction of rotation forward reverse forward reverse Pump on off on on Torque Ncm 20 60 20 20 Setting range Ncm 5 70 5 70...

Страница 36: ...r 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 wh...

Страница 37: ...and display when switching on 09 Foot control error Switch off device check plug contacts of foot control re start 19 Running time limiter Switch off device and re start 99 System failure Switch off...

Страница 38: ...ended 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...

Страница 39: ...nces 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...

Страница 40: ...he 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...

Страница 41: ...al 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 an...

Страница 42: ...e down 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 labor...

Страница 43: ...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 automat...

Страница 44: ...t 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...

Страница 45: ...ort 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 mo...

Страница 46: ...llowing 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 la...

Страница 47: ...on time at least 30 minutes at 121 C 250 F or at least 3 minutes at 134 C 273 F Maximum sterilization temperature 135 C 275 F Evidence of the basic suitability of the motor with cable and the universa...

Страница 48: ...48 Hygiene and maintenance Storage 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...

Страница 49: ...t 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...

Страница 50: ...tner 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...

Страница 51: ...30 Transportation case 04005900 Irrigant support 06352200 Fuse 250 V T1 6AH 16 W H accessories and spare parts Use only original W H accessories and spare parts or accessories approved by W H Supplier...

Страница 52: ...s 30185000 EM 19 motor without electrical contacts and 1 8 m cable 06290600 Hose clips 5 pcs 04363600 Irrigation tubing set 2 2 m 6 pcs 04719400 Irrigation tubing set 2 2 m 30285000 Foot control S N2...

Страница 53: ...ximum torque at motor 5 5 Ncm Motor speed range in the rated voltage range 300 40 000 rpm Coolant flow rate at 100 min 90 ml min Dimensions in mm height x width x depth 100 x 235 x 240 Weight in kg 2...

Страница 54: ...l Class II medical electrical equipment protective earth conductor used for functional earth connection only Type B applied part not suitable for intracardiac application S N2 REF 30285000 is approved...

Страница 55: ...isposal 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 Pa...

Страница 56: ......

Страница 57: ...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...

Страница 58: ......

Страница 59: ...d 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 pr...

Страница 60: ......

Страница 61: ...n a warranty period of 12 months from the date of purchase Accessories and consumables universal support coolant hose irrigant support fuse locator for foot control hose clips mains cable sterilizatio...

Страница 62: ...dshire AL2 2NJ United Kingdom t 44 1727 874990 f 44 1727 872254 E Mail technical uk wh com W H Impex Inc 6490 Hawthorne Drive Windsor Ontario N8T 1J9 Canada t 1 800 2656277 1 519 9446739 f 1 519 97461...

Страница 63: ......

Страница 64: ...Manufacturer W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com Form no 50874 AEN Rev 004 22 06 2018 Subject to alterations...

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