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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

12 Information about electromagnetic compatibility | 12.1 Guidelines and manufacturer's declaration - electromagnetic emis-
sion

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12 Information about electromagnetic compatibility

12.1 Guidelines and manufacturer's declaration - electromagnetic
emission

The MASTERsurg LUX Wireless is intended for use in an environment as specified
below. The MASTERsurg LUX Wireless customer or user must ensure that the unit is
used in an environment matching the description.

Measurements of emitted interfer-
ence

Conformance

Electromagnetic environment -
Guidelines

HF emissions according to CISPR
11

Group 1

The MASTERsurg LUX Wireless
uses HF energy exclusively for its
internal operation. Therefore, the
HF emission of the device is very
low and interference with adjacent
electronic devices is unlikely.

HF emissions according to CISPR
11

Class B

The MASTERsurg LUX Wireless is
intended for use in all facilities in-
cluding residential ones, and facilit-
ies that are directly connected to a
public power supply that also sup-
plies residential buildings.

Emission of harmonics according to
IEC 61000-3-2

Class A

The MASTERsurg LUX Wireless is
intended for use in all facilities in-
cluding residential ones, and facilit-
ies that are directly connected to a
public power supply that also sup-
plies residential buildings.

Emission of voltage fluctuations/
flicker according to IEC 61000-3-3

complies

The MASTERsurg LUX Wireless is
intended for use in all facilities in-
cluding residential ones, and facilit-
ies that are directly connected to a
public power supply that also sup-
plies residential buildings.

Note

The device or system may not be used or stacked directly next to other devices. If it
has to be used close to or stacked next to other devices, the device or system must
be monitored to ensure that it is used properly in the existing arrangement.

Note

The immunity test levels required in IEC 60601-1-2 (DIN EN 60601-1-2) are met.

12.2 Guidelines and manufacturer's statement - Electromagnetic
immunity

The MASTERsurg LUX Wireless is intended for use in an environment as specified
below. The MASTERsurg LUX Wireless customer or user should ensure that the unit
is used in an environment matching the description.

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Содержание 1.009.1200

Страница 1: ...Instructions for use MASTERsurg LUX Wireless REF 1 009 1200...

Страница 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Phone 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com...

Страница 3: ...4 Wireless foot control 17 3 5 Rating plates of MASTERsurg LUX Wireless and wireless foot control 17 3 6 Technical Specifications MASTERsurg LUX Wireless 19 3 7 Scope of delivery 20 4 Commissioning 21...

Страница 4: ...ant flow 46 5 6 4 Changing the direction of motor rotation 47 5 6 5 Setting the transmission ratio 48 5 7 Rinsing function 48 5 7 1 Manual rinsing function 48 5 7 2 Program activity rinsing function 4...

Страница 5: ...tic compatibility 70 12 1 Guidelines and manufacturer s declaration electromagnetic emission 70 12 2 Guidelines and manufacturer s statement Electromagnetic immunity 70 12 3 Guidelines and manufacture...

Страница 6: ...ment is for dentists and dental office staff 1 3 Service Please direct all questions regarding the product service and maintenance to the fol lowing addresses Please refer to the serial number of the...

Страница 7: ...bulbs glassware rubber parts and the colour fastness of plastics Defects or their consequences that can be attributed to interventions on or changes made to the product by the customer or a third part...

Страница 8: ...delivery re ceipt The recipient and the representative of the shipping company must sign this delivery receipt Without this evidence the recipient will not be able to assert a claim for damages agains...

Страница 9: ...Instructions for use MASTERsurg LUX Wireless REF 1 009 1200 1 User instructions 1 5 Transportation and storage Permissible stacking load Temperature range Humidity Air pressure 9 76...

Страница 10: ...at can cause damage to property or mild to moder ate injuries WARNING WARNING indicates a hazardous situation that can lead to serious or fatal injury DANGER DANGER indicates a maximal hazard due to a...

Страница 11: ...3304 3919 590 to enretec GmbH The following contact options are also available for questions and for initiating a disposal order Phone 49 0 3304 3919 500 Email eom enretec de and Postal address enret...

Страница 12: ...duct in a tub like container Check the coolant containers and lines for absence of leakage If any liquid is de tected on the device do not touch the device and disconnect the device from the mains sup...

Страница 13: ...wing Applicable regulations governing the connection and start up of medical devices Current occupational safety regulations Current accident prevention regulations It is a responsibility of the user...

Страница 14: ...sed of in strict compliance with all applicable national regulations in a manner which is safe both for people and the environment If you have any questions regarding proper disposal of the KaVo produ...

Страница 15: ...Wireless REF 1 009 1200 3 Description of the product 3 2 MASTERsurg LUX Wireless Rear 3 2 1 5 4 6 Hose pump locking mechanism On button Power plug Please note the instructions for use Follow the inst...

Страница 16: ...isplay of the activity Maximal torque reached Torque limit Speed Wireless foot control status indicator input implant position Activation of one touch calibration Coolant pump settings Direction of mo...

Страница 17: ...Direction of motor rotation key yellow 3 5 Rating plates of MASTERsurg LUX Wireless and wireless foot control The rating plates of MASTERsurg LUX Wireless and wireless foot control are affixed on the...

Страница 18: ...ontrol 18 76 Follow the instructions for use Operating mode continuous operation with intermittent load Alternating current AC Supply voltage Protection class II Manufacturer YYYY Year manufactured XX...

Страница 19: ...ontrol Class of protection IPX8 Wireless foot control Emitted power max 3 dBm e i r p Wireless foot control Frequency band ISM 2 4 GHz Length of motor cable 6 5 ft 2 m Operating mode Continuous operat...

Страница 20: ...livery The scope of delivery of the MASTERsurg LUX Wireless includes the following MASTERsurg LUX Wireless unit Wireless foot control Surgical motor INTRA LUX S600 LED Motor cable S600 Instrument tray...

Страница 21: ...ess foot control and additional equipment To take out the unit pull it vertically upward and place it on a level surface 4 2 Installing the bottle holder Slide the bottle holder in the guide on the un...

Страница 22: ...bar including the pump button program button and motor direc tion button slightly upwards and take it off the wireless foot control To open the lid turn it to the left and take it off Insert 3 batter...

Страница 23: ...ignated recesses The wireless foot control is now ready for operation and can be used The initial con nection is done at the factory Note Stand by mode The wireless foot control does not need to be sw...

Страница 24: ...dance with DIN EN ISO 17664 Page 58 1 2 3 4 Motor coupling Surgical motor Handpiece tray Plug of motor cable Plug the surgical motor into the motor coupling and secure it with a union nut Please note...

Страница 25: ...e of 1 litre only Check the stability Note The coolant must be selected to suit the planned application The flow rate of the coolant is dependent on the instrument used The user must set an adequate f...

Страница 26: ...ess REF 1 009 1200 4 Commissioning 4 5 Connecting the coolant container and hose set 26 76 ca 10 mm Coolant hose Clips Hose fixation Lock Pump hose Insertion needle Hose clamp Coolant hose Clip Hose f...

Страница 27: ...coolant hose tightly without loops or kinks against the outside of the motor cable and attach it in regular intervals using the enclosed clips Plug the hose fixation into the opening of the device wi...

Страница 28: ...cting the coolant container and hose set 28 76 ca 10 mm Open the lock and insert the pump hose Close the lock Note Make sure to place the pump hose in the pump appropriately such that the pump hose do...

Страница 29: ...a glass bottle open the ventilation on the puncture needle If you use a bag keep the ventilation on the puncture needle closed Open the hose clamp before startup Note Using a new hose it may take up...

Страница 30: ...riately such that the mains plug and the electrical outlet are easily accessible Note The protective earth conductor is used as functional earthing FE rather than as protective earthing PE Plug the ma...

Страница 31: ...ght on the handpiece the pump and the motor on the unit are turned off 5 2 Device settings The following device settings can be made or displayed Setting the language Setting the documentation Setting...

Страница 32: ...5 2 2 Setting the documentation Three modes are available Implant Documentation during implant insertion Permanent Documentation of entire treatment process on SD card Off Documentation disabled Touch...

Страница 33: ...fterglow 5 2 5 Setting the operating mode of the foot pedal The motor can be triggered in either of two operating modes The motor starts at full speed when the foot pedal is actuated The motor speed c...

Страница 34: ...d wireless foot control communicate these need to be connected The wireless foot control can be connected in three steps 1 Touch the symbol to start the connection process 2 Press and hold down the sp...

Страница 35: ...ge the date 5 2 10 Setting the LCD brightness The LCD brightness determines the brightness of the display The brightness can be set in 3 steps ranging from dark to maximal brightness Press the plus an...

Страница 36: ...able After start up you can start immediately with the first step of treatment Multiple programs After start up an overview of the 10 programs is displayed For each program up to 4 to 10 program steps...

Страница 37: ...store the factory settings In the window you will be asked whether or not you wish to carry out the action Touch Yes to carry out the action Press No or the back key to discontinue the action 5 2 17 V...

Страница 38: ...Following instructions for use service instructions and installation instructions in the motor handpiece and contra angle handpiece packaging All straight and contra angle handpieces with INTRAmatic...

Страница 39: ...ght or contra angle handpiece slightly to pull it off 5 4 Setting up multi program mode A total of 10 programs are available to the user These can be assigned e g to vari ous users or implant systems...

Страница 40: ...ns mission ratios and coolant flow rate for every activity according to application The parameters can be changed only within a reasonable range for the specific activity In the activity Free applicat...

Страница 41: ...im plant 15 50 20 D 5 80 25 D 16 1 27 1 20 1 D 0 4 0 D 6 Setting a clos ure cap 15 50 20 D 5 15 8 D 16 1 27 1 20 1 D 0 4 0 D 7 Free use 300 40 000 40 000 D 0 15 5 5 3 D 1 1 0 4 2 D 20 2 000 5 80 16 1...

Страница 42: ...ted can be set from pro gram step 4 Symbol Example 2 Program steps that do not include the activity Cut thread and include the Rinsing function activity Step 1 2 3 5 4 5 7 Activity Marking Pilot drill...

Страница 43: ...ogram step is saved automatically The program steps can be selected during the treatment using the program key of the wireless foot control After the last program step follows the first step again Pre...

Страница 44: ...ouch the activity display Select the flag symbol The settings are saved automatically and the treatment is terminated with the selected program step Navigating through the program steps with the wirel...

Страница 45: ...h the plus or minus area The value is saved automatically Press the back key to close the speed setting 5 6 2 Setting the torque limit Note The MASTERsurg LUX Wireless reduces the power to prevent the...

Страница 46: ...displayed during the treatment in the activities Cut thread Place implant and Set closure cap The value is re set as soon as the motor starts again 5 6 3 Setting the coolant flow CAUTION Coolant dosed...

Страница 47: ...g the treatment using the pump key of the wireless foot control The pump key has two operating modes See also 2 5 2 6 Setting the operating mode of the pump key of the foot control Page 33 The changed...

Страница 48: ...5 11 Wireless foot control Page 52 Three audible signals indicate counterclockwise rotation When the motor starts up 3 more audible signals are issued Note The set torque automatically increases by 5...

Страница 49: ...e speed key on the wireless foot control to start the rinsing function and control the coolant flow To terminate the rinsing function press the back key or the pump key 5 7 2 Program activity rinsing...

Страница 50: ...atios The calibration must be repeated whenever the handpiece is changed Touch the calibration symbol in order to start the One Touch calibration The display shows Press wireless foot control CAUTION...

Страница 51: ...rection of rotation program name implant position activity transmis sion ratio pump level software version and serial number of the unit to be recorded Three modes are available Implant A torque plot...

Страница 52: ...s on the wireless foot con trol or by touching the back key on the unit The updated torque plot is displayed again after each motor stop 5 11 Wireless foot control 5 11 1 Changing the speed coolant fl...

Страница 53: ...of the wireless foot control Press the program key of the wireless foot control briefly to select the next pro gram step Press the program key of the wireless foot control long to select the previous...

Страница 54: ...al connection Turn the device off Disconnect the power cable the socket of the supply mains Disconnect the power cable from the device 6 2 Disposal of the coolant hose Note The coolant hose with acces...

Страница 55: ...ing the surgical motor Disconnect the plug of the motor cable from the connector on the device Make sure to grasp the plug as close to the device as possible Note Cleaning and disinfecting the motor c...

Страница 56: ...speed button off the wireless foot control 1 Pull the button bar including the pump button program button and motor direc tion button slightly upwards and take it off the wireless foot control Turn t...

Страница 57: ...4 Plug the speed button onto the wireless foot control and press it on lightly until the snap in lug snaps in Make sure that the foot pedal springs are situated in the recesses of the housing 6 5 Dism...

Страница 58: ...structions for cleaning and sterilisation have been validated by the manufac turer Any departure from the instructions provided must be checked by the user for efficacy and possible detrimental conseq...

Страница 59: ...l parts of the wireless foot control under running water and then dry them 1 2 2 2 2 3 Plug the button bar onto the wireless foot control and press it on lightly until the button bar snaps into place...

Страница 60: ...Use of the thermodisinfector 7 2 Disinfection Note After each treatment of a patient the surfaces near the patient that may have been contaminated by contact or aerosol need to be disinfected All dis...

Страница 61: ...with accessories is intended for single use only and is not to be disin fected and sterilised No drying required Allow all disinfected and and sterilised parts to dry fully on room air before using t...

Страница 62: ...er sterilising and drying Note Treating patients who are possibly afflicted by an acute critical infectious disease be sure to comply with the hygienic measures cited in applicable publications and re...

Страница 63: ...s at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Drying time 30 min Note Allow the sterilised items to cool to room temperature before using them again 7 4 1 Storage Observe all necessary measures for hygiene whe...

Страница 64: ...he coolant flow Page 46 Hose fixation is not plugged in Plug in the hose fixation See also 2 4 5 Connecting the coolant container and hose set Page 24 Bottle is empty Connect new bottle Hose clamp is...

Страница 65: ...e engineer Event E6 Internal communication er ror Internal system error Turn the unit off and on If the problem persists notify service engineer Event E9 Setting the time and date Time was not reset a...

Страница 66: ...erform a run in the absence of the straight or con tra angle handpiece If no error message is displayed the handpiece runs too sluggish Use a different straight or contra angle handpiece If the run in...

Страница 67: ...the bin file extension the downloaded current file is stored on the SD card Turn the device on The update process starts automatically Note The unit must not be turned off during the update process Af...

Страница 68: ...bol Description green Service check is soon due Arrange a precautionary appointment at a KaVo subsidiary or with a KaVo authorised dealer yellow Service check is due Arrange an appointment at a KaVo s...

Страница 69: ...Wireless Hose set sterile S600 10 pcs Mat no 1 009 8757 Hose set sterilisable S600 Mat no 1 011 0633 Handpiece tray Mat no 1 009 3411 Motor INTRA LUX S600 LED Mat no 1 008 8000 Motor cable S600 Mat no...

Страница 70: ...cted to a public power supply that also sup plies residential buildings Emission of harmonics according to IEC 61000 3 2 Class A The MASTERsurg LUX Wireless is intended for use in all facilities in cl...

Страница 71: ...environment Voltage interruptions short term interruptions and fluctuations of the sup ply voltage according to IEC 61000 4 11 5 UT for 1 2 period 95 interruption 40 UT for 5 periods 60 interruption...

Страница 72: ...80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not be applicable in every case The propagation of electromagnetic waves is subject to absorption and reflection by b...

Страница 73: ...1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters whose maximum rated power is not included in the above table the recommended safe distance d in metres m can be calculated using the...

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Страница 76: ...1 010 3594 bd 20161206 04 en...

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