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KaVo EXPERTsurg LUX, Инструкция по эксплуатации

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KaVo EXPERTsurg LUX Скачать руководство пользователя страница 66

Instructions for use EXPERTsurg LUX – 1.008.3500

13 Information concerning the electromagnetic compatibility according to IEC 60601-1-2 | 13.2 Results of the elec-
tromagnetic tests

66 / 68

Requirement

Class / test level

Voltage interruptions, short-term interruptions and
fluctuations of the supply voltage

-

Electrical cables

0 % / 0.5 cycle
at 45° steps
from 0°- 315°
0 %/ 1 cycle
70 %/ 25 cycles
0 %/ 250 cycle

Содержание EXPERTsurg LUX

Страница 1: ...Instructions for use EXPERTsurg LUX 1 008 3500...

Страница 2: ...tributed by KaVo Dental Technologies LLC 11727 Fruehauf Drive Charlotte NC 28273 USA Phone 847 550 6800 Fax 847 550 6825 Manufacturer KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany www kavo c...

Страница 3: ...20 4 Startup 22 4 1 Unpacking 22 4 2 Installing the bottle holder 22 4 3 Plugging in the foot control 22 4 4 Connecting the surgical motor 23 4 5 Connecting the coolant container and hose set 24 4 6...

Страница 4: ...cessing 51 6 2 1 Automated cleaning and disinfection 51 6 2 2 Service inspection and testing after processing 51 6 3 Packaging 52 6 4 Sterilization 52 6 5 Storage 53 7 Run a software update 54 8 Acces...

Страница 5: ...marks and symbols See Chapter on User Instructions Hazard Levels Important information for users and service technicians Action request Original language German CE mark European Community A product b...

Страница 6: ...in all inquiries Please refer to the serial number of the product in all inquiries For further infor mation please visit www kavo com KaVo Repair Service For repairs please contact the KaVo Repair Se...

Страница 7: ...Carry out the processing as described in the instructions for use The proce dure has been validated by the manufacturer 4 If you deviate from this validated procedure make sure that the processing pro...

Страница 8: ...se slipping or tripping 4 Power supply and cord hoses need to be set up routed appropriately such that they are not on the floor Failure of the voltage supply or other errors can cause the surgical mo...

Страница 9: ...ea or lens of the eye 4 Do not gaze into the lamp when it is in operation 4 Use adequate shielding for eye protection 2 8 Qualification of personnel Application of the product by users lacking appropr...

Страница 10: ...check 2 10 Information on electromagnetic compatibility NOTICE Property damage due to unsuitable accessories The use of accessories other components and cables other than those speci fied with the ex...

Страница 11: ...h software on the surgical control unit 3 1 Intended use Indications for use This KaVo product is intended for use in surgery to expose and dissect oral tis sue structures or endodontic treatments e g...

Страница 12: ...d work is described in the Technician s Instructions available to the trained service staff Operators equipment managers and users in Germany are obliged to operate their equipment in accordance with...

Страница 13: ...cope of delivery of the EXPERTsurg LUX includes the following Device EXPERTsurg LUX Foot control Surgical motor INTRA LUX S600 LED Motor cable S600 Handpiece holder Hose set sterile S600 5 pcs Bottle...

Страница 14: ...ion 3 3 EXPERTsurg LUX 14 68 3 3 EXPERTsurg LUX 1 2 7 8 3 6 5 4 9 10 Product reference guide front view Hand held control panel Surgical motor Bottle holder Coolant hose Hose pump Handpiece holder Hos...

Страница 15: ...500 3 Product description 3 3 EXPERTsurg LUX 15 68 Rear Product reference guide rear view Hose pump locking mechanism Follow instructions for use On button SD card slot Mains plug Foot control electri...

Страница 16: ...p settings Left arrow key Activation Plus key increase value One touch calibration Right arrow key Foot control status indicator Motorized device connector Call for service check Key Function The back...

Страница 17: ...nstructions for use EXPERTsurg LUX 1 008 3500 3 Product description 3 5 Foot control 17 68 3 5 Foot control 1 3 2 4 Speed key grey Program key grey Pump key blue Direction of motor rotation key yellow...

Страница 18: ...trol Protection class IPX8 Foot control Cable length 2 5 m Length of motor cable 2 m Operating mode Continuous operation with duty type 30 sec operation 9 min pause NOTE The maximal motor load is 30 s...

Страница 19: ...rside of the housing Accompanying documents Note Please note accompanying documents Follow instructions for use Please note the electronic instructions for use HIBC Code Certification CE mark for medi...

Страница 20: ...torage NOTE Please keep the packaging in case you need to return the product for servic ing or repair Transportation and storage conditions Temperature 29 C to 50 C 20 F to 122 F Relative humidity 5 R...

Страница 21: ...28 Outside Germany NOTE KaVo shall not be held liable for damage arising from transportation The shipment must be checked on arrival If the packaging is visibly damaged on delivery please proceed as f...

Страница 22: ...o be able to safely ship the unit in the future 4 Open the cardboard box 4 Remove the hose boxes 4 Take out the foot control and additional equipment 4 To take out the unit pull it vertically upward a...

Страница 23: ...p into the designated recesses 4 4 Connecting the surgical motor NOTE The delivered parts are not sterile except for the coolant hose Before the first treatment of a patient the surgical motor motor c...

Страница 24: ...of the motor 4 Place the surgical motor on the handpiece holder 4 Insert the plug of the motor cable into the connector on the device align the marker points and insert the plug until it snaps into p...

Страница 25: ...oolant and check this Check the integrity of the hose set before use If product or packaging are damaged the product needs to be discarded Inserting the hose in the pump make sure that the flow direct...

Страница 26: ...or contra angle handpiece 4 Place the coolant hose tightly without loops or kinks against the outside of the motor cable and attach it in regular intervals using the enclosed clips 4 Plug the hose fix...

Страница 27: ...olant container and hose set 27 68 ca 10 mm 4 Open the lock and insert the pump hose 4 Close the lock NOTE Make sure to place the pump hose in the pump appropriately such that the pump hose does not g...

Страница 28: ...entilation on the puncture needle 4 If you use a bag keep the ventilation on the puncture needle closed 4 Open the hose clamp before startup NOTE Using a new hose it may take up to approx 10 seconds f...

Страница 29: ...h that the mains plug and the elec trical outlet are easily accessible NOTE The protective earth conductor is used as functional earthing FE rather than as protective earthing PE 4 Plug the mains cabl...

Страница 30: ...tings The procedure for changing or displaying the device settings is always the same The basic procedure is described in the following Key Function 4 Press the back key for a long time until the devi...

Страница 31: ...Ds of the straight or contra angle handpiece afterglow af ter each motor stop The afterglow time can be set in the range from 0 to 10 seconds Operating mode of the foot pedal The motor can be triggere...

Страница 32: ...been made Importing settings The import of device settings allows the user to import all device settings from the SD card in a SURG_EX SET file This allows a defined status to be restored e g if sett...

Страница 33: ...cording to ISO 3964 can be attached 4 Place the KaVo handpiece on the motor lightly press it against the motor while turning it slightly in the direction of the arrow until the guide stud can be heard...

Страница 34: ...lecting the corresponding symbol Visualizing the activity is an easy means for checking if the activity set on the device is the same as the current treatment step Operating errors can thus be largely...

Страница 35: ...1 20 1 D 0 4 2 D 2 Pilot drilling 200 2 000 500 D 5 20 10 D 16 1 27 1 20 1 D 0 4 2 D 3 Template drilling 200 2 000 500 D 5 20 10 D 16 1 27 1 20 1 D 0 4 2 D 4 Tapping 15 50 20 D 5 80 25 D 16 1 27 1 20...

Страница 36: ...commendations concerning implants handpieces and burs 5 4 2 Exemplary program step sequences Example 1 Factory setting Step 1 2 3 4 5 6 7 8 Activity Marking Pilot drilling Template drilling Tapping Pl...

Страница 37: ...om pro gram step 4 Symbol 5 4 3 Selecting the program steps 4 Press the arrow keys until the program step display is highlighted 4 Press the plus and minus keys to select the desired program step The...

Страница 38: ...4 4 Press the arrow keys until the program step display is highlighted 4 Press the plus and minus keys to select program step that completes the treatment can be set from program step 4 4 Press the ar...

Страница 39: ...e step width de pends on the transmission ratio and the range of values Changed values are stored automatically 5 5 1 Setting the maximum speed 4 Press the arrow keys until the speed display is highli...

Страница 40: ...alues are stored automatically The maximum torque value reached is displayed during the treatment in the activities Tapping Set implant and Set closure cap The value is re set as soon as the motor sta...

Страница 41: ...ed values are stored automatically The coolant flow can be set and switched on or off during the treatment using the pump key of the foot control The pump key has two operating modes Also refer to 5 2...

Страница 42: ...5 8 Foot control Page 46 A total of 3 audible signals indicate counterclockwise rotation When the motor starts up 3 more audible signals are issued NOTE The set torque automatically increases by 5 Ncm...

Страница 43: ...tion serves to feed coolant and to start up the illumination on the handpiece The motor is not activated during this process The rinsing function can be called up manually at any time 4 Press the pump...

Страница 44: ...ly compensates for torque deviations of the motor that may be caused e g by aging processes When the handpiece is attached the unit detects if the handpiece runs sluggish or is defective The one touch...

Страница 45: ...e foot control before the display shows that the calibration was successful press the foot control again until the display shows a mes sage indicating that the calibration was successful 4 Press the b...

Страница 46: ...tor rotation The direction of motor rotation can be changed during the treatment using the direction of motor rotation key of the foot control The changed direction of motor ro tation is shown on the...

Страница 47: ...ontainer The coolant container can be changed during the treatment as follows 4 Close the hose clamp 4 Pull the hose and puncture needle out of the empty coolant container 4 Replace the empty coolant...

Страница 48: ...processing instructions have been validated by the manufacturer Any de parture from the instructions provided must be checked by the processing en tity for efficacy and possible detrimental consequenc...

Страница 49: ...tton bar including the pump button program button and mo tor direction button slightly upwards and take it off the foot control 1 4 Brush off the individual parts of the foot control under running wat...

Страница 50: ...nd motor cable Approved disinfectants application range in accordance with the available man ufacturer s instructions for use and national guidelines Please note material safety data sheets KaVo recom...

Страница 51: ...nfector should at least provide the following program steps Automated cleaning procedure 4 Step 1 Pre cleaning with cold tap water for 1 min 4 Step 2 Cleaning 0 5 cleaner 55 C for 5 min with de ionize...

Страница 52: ...nistration FDA CAUTION Improper service and care Risk of injury 4 Perform regular proper care and servicing NOTICE Improper sterilization Contact corrosion damage to the sterilized items 4 Do not perf...

Страница 53: ...ation cycles Sterilizer with triple pre vacuum 3 minutes at 135 C 275 F Drying time 16 min Sterilizer using the gravity method 10 minutes at 135 C 275 F Drying time 30 min 4 Remove the medical device...

Страница 54: ...file extension the downloaded current file is stored on the SD card 4 Turn the device on The update process starts automatically NOTE The unit must not be turned off during the updating process After...

Страница 55: ...sories are approved for the EXPERTsurg LUX Hose set sterile S600 10 pcs 1 009 8757 Hose set sterilizable S600 1 011 0633 Handpiece holder 1 009 3411 Motor INTRA LUX S600 LED 1 008 8000 Motor cable S60...

Страница 56: ...aVo Box www kavobox com or contact your KaVo specialist dealer yellow Service interval exceeded 4 Visit KaVo Box www kavobox com or contact your KaVo specialist dealer red Service interval exceeded 4...

Страница 57: ...g ta bles have trained service personnel perform the repair The technician s in structions are available to the service personnel for servicing and repair work In case of malfunction the display ident...

Страница 58: ...e hand piece 4 Use a suitable light straight and contra angle handpiece Error message from software Malfunction Cause Remedy Event E3 Release foot pedal Foot control was acti vated while the unit star...

Страница 59: ...e handpiece If no error message is displayed the handpiece runs too sluggish 4 Use a different straight or contra angle handpiece If the run without the straight or contra angle handpiece again pro du...

Страница 60: ...product and accessories before disposal Also refer to 6 Reprocessing steps in accordance with ISO 17664 Page 48 11 1 Disconnecting the electrical connection 4 Turn the device off 4 Disconnect the pow...

Страница 61: ...r 4 Open the lock and remove the hose 4 Remove the hose set from the unit and dispose of it 11 3 Disconnecting the surgical motor 4 Unplug the plug of the motor cord from the connector on the device M...

Страница 62: ...he foot control from the connector on the device Make sure to grasp the plug as close to the device as possible 11 5 Dismantling the bottle holder The bottle holder can be disassembled if the device i...

Страница 63: ...entioned Directive and must be subjected to special disposal in Europe For more information please visit www kavo com or contact your specialized dental supplier Final disposal in Germany To return an...

Страница 64: ...n 4 The use of other devices in the immediate vicinity of this product or placed on top of this product should be avoided as this may lead to faulty operation of the unit However if this kind of use w...

Страница 65: ...ital mobile phones and other HF emitting devices 80 MHz 2700 MHz 3 V m High frequency electromagnetic fields in the immediate vicinity of wireless communication devices 385 MHz 27 V m 450 MHz 28 V m 7...

Страница 66: ...compatibility according to IEC 60601 1 2 13 2 Results of the elec tromagnetic tests 66 68 Requirement Class test level Voltage interruptions short term interruptions and fluctuations of the supply vol...

Страница 67: ...o shall not be liable for defects and their consequences that have arisen or may arise from natural wear improper handling cleaning maintenance or ser vicing non compliance with operating maintenance...

Страница 68: ...1 010 3621 bd 20221018 10 en US...

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