W&H implantmed SI-923, Instructions For Use Manual

Page 1: ...Instructions for use SI 923 SI 915...

Page 2: ...cable 20 10 Starting operation General 21 11 Switch on switch off Implantmed 22 12 Control unit operation 23 26 13 Foot control operation 27 28 14 Factory settings 29 31 15 Thread cutter function chip...

Page 3: ...Sterilizable up to the stated temperature Thermo washer disinfectable Symbols in the instructions for use For USA and Canada Caution Federal law restricts this device to sale by or on the order of a d...

Page 4: ...Frequency of the alternating current Hz Data matrix code for product identification e g for hygiene maintenance processes Not suitable for intracardiac application Type B applied part Foot switch Do...

Page 5: ...any other practitioner licensed by the law of the state in which he or she practices to use or order the use of the device Fragile handle with care Keep away from rain Temperature limit Humidity limi...

Page 6: ...ice to sale by or on the order of a dentist physician or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of the device Batch ID CE 0481 fro...

Page 7: ...anical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964 DIN 13 940 The equipment is a drive unit for use in dental surgery implantology and maxill...

Page 8: ...nd performance of the Implantmed when it is used in compliance with the following directions The Implantmed must be used in accordance with these Instructions for use The Implantmed has no components...

Page 9: ...nal W H accessories and spare parts The use of other accessories other spare parts can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic...

Page 10: ...recycling companies However we recommend that you keep the original packaging Lift out the insert with the stand Lift out the insert with the foot control Lift out the insert with the control unit Re...

Page 11: ...CAN J REF 03212700 UK IRL REF 02909300 AUS NZ REF 04280600 CH REF 05901800 DK Foot control S N1 REF 06202400 Handle for foot control REF 04653500 Motor with 1 8 m cable REF 06631600 incl 5 clips REF...

Page 12: ...ts or refer to an authorized W H service partner see page 52 Do not operate the Implantmed if it is damaged When changing the fuse disconnect the unit from the power supply and only use W H original f...

Page 13: ...d out if patients and users have an implanted device before using the product and consider the applications Weigh the risks and benefits Keep the product away from implanted devices Make appropriate e...

Page 14: ...s may form due to the use of anaesthesia or medical antiseptics and antibacterial soaps such atmospheres are limited and only occur very briefly Please note that at low speeds it is more difficult to...

Page 15: ...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 Simply switch the unit off...

Page 16: ...ng is a disposable article and must be discarded after each treatment Please note the expiry date and the relevant regulations for disposal of irrigation tubing Only use disposable irrigation tubing w...

Page 17: ...17 6 Description of front panel Motor connection socket Display Pump arm OPEN Program buttons P1 Pump arm Stand holder P2 P3 P4 P5...

Page 18: ...18 7 Description of rear panel Connecting socket for foot control Fuse holder with 2 fuses REF 06661800 2 x 250 V T1 25AH Power socket Power switch ON OFF Stand holder...

Page 19: ...andle attach detach GREEN Pump ON OFF GREY Start motor pedal VARIABLE or ON OFF Factory setting variable ORANGE Change program Programs 1 to 4 and torque steps 20 60 Ncm in program 5 YELLOW Change mot...

Page 20: ...e illustration The locking pin can only be used in combination with straight and contra angle handpieces that have corresponding holes The motor with cable is defined as a type B applied part Temperat...

Page 21: ...ention to the positioning maximum load capacity 1 5 kg Attach the motor support and lock it Insert the irrigation tubing Open the pump arm a Fit the irrigation tubing set b c d Follow the same sequenc...

Page 22: ...ower switch Switch off Implantmed Turn the Implantmed off at the power switch Disconnect the Implantmed from the power supply Test run Start the motor In the event of malfunctions e g vibrations unusu...

Page 23: ...ights up The selected program 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 operation ON OFF Display settings P4 P5 Torque...

Page 24: ...Pressing and holding PLUS MINUS depressed activates the repeat function and the values are continuously increased decreased Press program button P1 P3 Increase speed Decrease speed The accuracy of th...

Page 25: ...ard 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 program button P4 or...

Page 26: ...ecrease the values Keep P2 depressed for approx 4 seconds the set coolant flow rate will appear Continue to keep P2 depressed and increase the flow rate using the PLUS button Continue to keep P2 depre...

Page 27: ...tomatically set to forward operation 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 The pump symbol appears on the di...

Page 28: ...edure Keep P3 depressed for approx 4 seconds Continue to keep P3 depressed and simultaneously press the PLUS and MINUS buttons Continue to keep P3 depressed and set the adjusting 01 VARIABLE factory s...

Page 29: ...ry settings Switch off control unit Keep P1 depressed and simultaneously switch on the control unit Keep P1 depressed until the setting DE FAU appears on the display The factory setting always starts...

Page 30: ...settings P1 P3 P1 P2 P3 Transmission ratio 1 1 20 1 20 1 Speed rpm 35 000 1 200 800 Adjustable range rpm 300 40 000 15 2 000 15 2 000 Motor direction forward forward forward Pump on on on Torque Ncm 1...

Page 31: ...e P5 forward P5 reverse Transmission ratio 20 1 20 1 20 1 20 1 Speed rpm 15 30 20 20 Motor direction forward reverse forward reverse Pump on off on on Torque Ncm 20 60 20 20 Adjustable range Ncm 5 70...

Page 32: ...an no longer be changed When the foot pedal grey on the foot control is pressed the thread cutter rotates inwards until the set torque is reached When the set torque is reached the device automaticall...

Page 33: ...trol re start 19 Running time limiter Switch off device and re start 99 System failure Switch off device allow motor to cool for at least 10 minutes re start Motor temperature too high Motor plug in c...

Page 34: ...nning water Control unit foot control Pre disinfection If heavily soiled clean first with disinfectant cloths Only use disinfectants that have no protein fixing effects Manual cleaning and disinfectio...

Page 35: ...tenance Motor with cable Do not twist or kink the motor cable Do not coil it too tightly Pre disinfection If heavily soiled clean first with disinfectant cloths Only use disinfectants that have no pro...

Page 36: ...isinfectants wiping disinfection is recommended Use only disinfectants which do not contain chlorine and which are certified by officially recognized institutes Note the manufacturer s specifications...

Page 37: ...be cleaned and disinfected in a thermo washer disinfector W H permits preparation in a thermo washer disinfector with a drying program Follow the manufacturer s recommendations for devices cleaning a...

Page 38: ...sterilization with pre and post vacuum cycle Observe the device manufacturer s instructions Clean and disinfect prior to sterilization Wrap the motor with cable and accessories in sterile goods packag...

Page 39: ...terilizer manufacturer must give its express approval for the sterilization of motors Sterilization holding time a minimum of 3 minutes at 134 C For USA and Canada Steam vacuum sterilization hospital...

Page 40: ...spare parts or accessories approved by W H 04013500 Sterilization cassette 04013600 Transportation case 04541900 Trolley white 04542100 Trolley white with power sockets 06177800 Motor support 04005900...

Page 41: ...sories 06631600 Motor with 1 8 m cable incl 5 clips 04019000 Clips 5 pcs 04363600 Irrigation tubing 2 2 m 6 pcs 2 04719400 Irrigation tubing 2 2 m 06202400 Foot control S N1 04653500 Handle for foot c...

Page 42: ...es Visual inspection for outside damage Measurement of device leakage current Measurement of patient leakage current Visual inspection of internal components on suspicion of safety interference e g me...

Page 43: ...t after 500 sterilization cycles or one year Repairs If a defect occurs always return all the equipment because motor malfunctions an inspection of the electronic controls is also necessary Returns Re...

Page 44: ...Ncm Motor speed range in the nominal voltage range 300 40 000 min 1 300 40 000 min 1 Coolant flow rate at 100 at least 90 ml min at least 90 ml min Operating mode S3 3min 10min S3 3min 10min Dimension...

Page 45: ...up to 3 000 m above sea level Class II equipment Type B applied part not suitable for intracardiac application The foot control REF 06202400 conforms to Class AP according to IEC 60601 1 ANSI AAMI ES...

Page 46: ...pecific laws directives standards and guidelines for the disposal of used electrical devices Ensure that the parts are not contaminated on disposal Disposal of the packaging material All packaging mat...

Page 47: ...te Signature W H Surgical Unit Type SN Name of the user customer Clinic department Address Signature The user customer has been trained in all functions of the surgical unit in accordance with the cur...

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Page 49: ...ignature CERTIFICATION OF TRAINING essential for EU user customer The user customer has been trained in all functions of the surgical unit in accordance with the current Instructions for Use Particula...

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Page 51: ...e been followed As the manufacturer W H is liable for material or manufacturing defects within a warranty period of 12 months from the date of purchase We accept no responsibility for damage caused by...

Page 52: ...W H Impex Inc 6490 Hawthorne Drive Windsor Ontario N8T 1J9 Canada t 1 800 2656277 1 519 9446739 f 1 519 9746121 E Mail service ca wh com W H Impex Inc 14300 Henn Rd Dearborn MI 48126 USA t 1 800 26562...

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Page 54: ...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 50731 AEN Rev 003 30 05 2014 Subject to alterations...