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Post-use Maintenance

3

Place the products into the washer-disinfector�

4

Run the washer-disinfector cycle to clean and
disinfect the products� Use a Miele washer-disinfector
PG8581 (or equivalent device)�

5

Remove the products from the washer-disinfector�

6

Remove any remaining moisture from the product
using a dry cloth or filtered clean and dry
compressed air (≤0�35 MPa) ensuring it is dry
internally and externally�

7

Under appropriate lighting (≥500 lx), inspect the
products for contamination�
If any visible contamination remains, repeat the
process until it is visually clean following step 3�

8

Remove the protection plug from the motor with
motor cord� Proceed to the section “6 – 3
Sterilization”�

Due to the variation in cleaning/disinfection cycles and cleaning agents available from the various manufacturers, NSK
has validated the Miele washer-disinfector PG8581 Cycle Vario TD (see the table below) for automatic processing/
reprocessing of the products�
Only validated procedures must be used for cleaning and sterilization� When using reprocessing procedures that are
different from those described in this manual, those procedures must be validated by the respective practice or hospital
using washer-disinfector that conforms to EN ISO 15883-1�

Step1

Precleaning cold tap water for 1 minute�

Step2

Cleaning 0�5% cleaner 55 ˚C for 5 minutes with demineralized water�

Step3

Rinsing with demineralized water for 1 minute�

Step4

Thermodisinfection with demineralized water at 93 ˚C for 5 minutes�

Step5

Dry the products for 5 minutes at 80-100 ˚C

CAUTION

●

Products must be removed from the washer-disinfector straight away (within 1 hour) after the cleaning,
disinfecting and drying cycle is complete to prevent corrosion�

●

After using the washer-disinfector, dry the product completely, because remaining moisture may cause internal
corrosion, etc�

●

After cleaning and disinfection of the products, be sure to perform “6 – 3 Sterilization”�

●

Use a cleaning and disinfection device (washer-disinfector) complying with EN ISO 15883-1 (e�g� Miele washer-
disinfector PG8581), that operates with a maximum pH value of 10�5 (e�g� neodisher MediClean, Dr� Weigert) �
Proof of suitability for the process must be obtained from the washer-disinfector manufacturer�

●

Automated cleaning and disinfection should be done in accordance with the operation manual of the washer-
disinfector�

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Содержание Surgic Pro2

Страница 1: ......

Страница 2: ...circuit 21 5 4 Sleep mode 21 5 5 Link function 22 6 Post use Maintenance 26 6 1 Preparation for maintenance 26 6 2 Cleaning and disinfection 26 6 3 Sterilization 29 6 4 Storage 29 7 Maintenance 30 7 1 Replace the O ring 30 7 2 Periodical maintenance checks 30 7 3 Foot control calibration 31 8 Setting 32 8 1 Setting key 32 8 2 Implant system 37 8 3 Programming the system operation 38 9 Troubleshoot...

Страница 3: ...e knife is in the vicinity and used Do not operate close to patients with cardiac pacemakers as there is a danger that it may affect the pacemaker Do not use in rooms with a risk of explosion or near flammable substances Also do not use on or near patients under flammable anesthesia Nitrous Oxide Be sure to calibrate this product every time before use Without calibration there is a risk that the s...

Страница 4: ...ion and rusting Do not lubricate the motor with motor cord Oil could generate excessive heat and cause damage The control unit can be cleaned with a moist cloth Disconnect the power supply before cleaning The control unit and the foot control cannot be sterilized by any method When the system is very frequently used consider keeping a small stock of replaceable parts Do not disconnect the motor co...

Страница 5: ...ng and Operation NOTICE Turn off the main power switch after each use For service requirements and spare parts contact an authorized NSK dealer No special training is required for Qualified Professionals to operate this device ...

Страница 6: ...Solution Hanger Post 1 Optic Handpiece Non Optic Handpiece 1 Optic Motor Non Optic Motor with motor cord 1 Y Connector 1 AAA Alkaline Battery 3 Pack 1 No Part Name Quantity Tube Holder 7 Handpiece Stand 1 Internal Spray Nozzle 1 Nozzle Holder 1 Cleaning Wire 1 Calibration Bur 1 E Type Spray Nozzle 1 Protection Plug 1 O Ring Protection Plug 2 O Ring Motor 2 Either handpiece motor is included ...

Страница 7: ...scription 3 2 Control unit foot control Control unit Control panel LCD display Irrigation pump Calibration load Motor cord socket Coolant solution hanger post holder Main power switch AC power cord connector socket ...

Страница 8: ...ft button Select coolant solution flow level Press and hold for more than 2 seconds Switching operation between this product and linked device Center button Program number change Select a program number Depressing for about two seconds goes back one program Right button Change direction of rotation Press and hold for more than 2 seconds Motor LED illumination while button is depressed Speed contro...

Страница 9: ...ly to select the implant system See 8 2 Implant system MEMORY Key Memorize the program parameters gear ratio maximum rotation speed rotation direction torque upper limit coolant solution flow level light level GEAR Key Select the gear ratio 20 1 1 1 1 2 1 3 1 5 FWD REV Key Select the direction of rotation Forward rotation Reverse rotation CALIBRATION Key Calibrate the handpiece See 5 1 Calibration...

Страница 10: ...ay Not connected COOLANT Key Select the coolant solution flow level from 0 to 5 LIGHT Key Select the light level OFF LOW HIGH Displays the current operating torque each bar means 10 100 50 Displays the battery level of the foot control Check the battery level before and after treatment Replace the batteries when the display of battery level is flashing 50 100 10 50 flashing Less than 10 0 Displays...

Страница 11: ...case and make sure batteries are inserted in the correct orientation Use only high quality disposable AAA Micro LR03 1 5V alkaline batteries Using the wrong type of battery may lead to product malfunction Do not mix new and old batteries or different types of batteries Do not use rechargeable batteries If the device will not be used for a long period of time remove the batteries for safety reasons...

Страница 12: ...ger such as when putting it in the carrying case remove it by the reverse of the procedure for attaching If the hanger is stiff pull it out alternating between right and left CAUTION When holding the foot control do not hold with the hanger retracted It may cause the hanger to come out and the foot control to fall 4 4 Mounting the coolant solution hanger post Mount the coolant solution hanger post...

Страница 13: ...he cover is closed the tube could be cut or sheared Do not use non NSK genuine irrigation tubing When mounting the irrigation tube be careful not to get your hand caught in the moving part of the irrigation pump Do not mount the irrigation tube while the power is ON Do not use the irrigation tube if the pouch is punctured or the seal is broken It is not sterile Federal law restricts this device to...

Страница 14: ...e needle and the irrigation pump 2 Insert the irrigation tube needle into the bottle cap 3 Open the tube cap to supply air into the bottle 4 Open the tube clamp CAUTION Do not operate the irrigation pump if the tube is bent or the tube clamp is in the closed position This could cause the tube to break or slip out of the bottle ...

Страница 15: ...use breakage or deformation 4 8 Connecting the handpiece 1 Push the handpiece on to the motor taking care to keep it in alignment 2 Twist the handpiece until it locks into position with a clicking sound CAUTION When using the optic Surgic Pro2 micromotor use only optic handpieces A non optic handpiece may not precisely connect to the micromotor and it may malfunction when the micromotor is under l...

Страница 16: ...ected 2 Make sure the control unit main power switch is in the OFF position side and then connect to a commercial power socket 3 Put the control unit main power switch in the ON position side 4 Confirm compatibility as covered in 4 11 1 Compatibility check of internal spray nozzle drill 5 Run the motor for 1 minute and check the following Is the bur or drill free from rattling abnormal vibration o...

Страница 17: ...nto the drill from the back 4 Turn the control unit power on and irrigate at maximum flow for about 5 seconds Points to be checked Cleanliness of the saline solution coming out from the drill If solution is colored there could be rust inside of the drill If so replace the drill If coolant solution flow level is low the exit point of the nozzle may become clogged with cut bone powder Clean it or re...

Страница 18: ...uction handpiece listed in 10 1 Contra angle handpieces Correct calibration cannot be done if other handpieces are used Microsaw handpiece cannot be calibrated Calibration should be performed only on an NSK handpiece Only speed calibration is performed if the gear ratio is other than 20 1 Press the cancel key for 2 seconds to return to the normal screen from calibration mode 5 1 1 Calibration prep...

Страница 19: ...l stop Torque calibration with load 1 Make sure H is displayed on the LCD display 2 Plug the calibration bur into the calibration load 3 Hold the handpiece firmly so the calibration bur is perpendicular to the calibration load 4 Press CALIBRATION 5 A beep sounds and the calibration bur automatically rotates for a few seconds 6 Calibration is complete when a beep sounds and PASS appears on the disp...

Страница 20: ...contacting anywhere 2 A beep sounds and the calibration bur automatically rotates for a few seconds at high speed 3 Calibration is complete when a beep sounds and SUCCESS appears on the display 4 The LCD display will return to the normal screen Calibration fail example If a problem occurs such as the gear being extremely worn correct data cannot be obtained at calibration and FAIL is displayed In ...

Страница 21: ... normal screen see 9 2 Problems and solutions 2 Press to select a program number 3 Confirm settings such as gear ratio maximum rotation speed direction of rotation torque upper limit coolant solution flow level and light level and change them as necessary 4 Depress the pedal on the foot control to activate the motor Select a program number When you press and hold the button for more than 2 seconds...

Страница 22: ...he functions will differ from those above 5 3 Protection circuit A protection circuit automatically functions to protect the motor and the control unit if the motor is ever overloaded Power supply to the motor will automatically be terminated and an error code will be displayed on the control unit Resetting the protection circuit To reset the protection circuit release the speed control pedal and ...

Страница 23: ...SET is displayed 2 Press 3 Press to select sub menu Foot control Osseo 100 VarioSurg 3 External terminal See 8 1 1 Pairing with foot control See 5 5 1 Osseo integration Monitoring Device Osseo 100 See 5 5 2 Link Module See 5 5 3 External terminal Press NOTICE Refer to the operation manual of the device to be connected for the use method and use environment If pairing is not completed within 5 minu...

Страница 24: ...Pro2 See the Osseo 100 manual for the method of use 1 Press the operating key to turn on Osseo 100 2 Press and hold the operating key at least 3 seconds 3 Confirm the PA is displayed 4 Pairing is successful when Surgic Pro2 beeps and displays OK Make sure icon below is displayed and the device is connected 5 Press twice to end setting mode CAUTION If any abnormalities are found with Osseo 100 refe...

Страница 25: ...urns blue release the button 4 Pairing is successful when Surgic Pro2 beeps and displays OK Make sure icon below is displayed and the device is connected Also the LED of the Link Module turns green 5 Press twice to end setting mode CAUTION If any abnormalities are found with VarioSurg 3 and Link Module refer to the respective operation manuals If the button is not released after the LED turns blue...

Страница 26: ...he application for how to use the application Download the dedicated application from the following www nsk dental com qr app surgicpro2 See 10 4 Compatible terminals for compatible terminals 1 Launch the App 2 Touch the icon 3 Touch Start 4 Enter the code 123456 and touch Pair 5 Pairing is successful when Surgic Pro2 beeps and displays OK Make sure icon below is displayed and the device is connec...

Страница 27: ...e handpiece operation manual 6 2 Cleaning and disinfection Manual Method For the motor with motor cord and handpiece stand _Cleaning 1 Remove the tube holder gray from the motor with motor cord For cleaning and disinfection of the tube holder gray see For the tube holders tube holder gray calibration bur and protection plug 2 Attach the protection plug to the motor with motor cord 3 Clean the surf...

Страница 28: ...amination If any visible contamination remains repeat the process until it is visually clean following step 1 _Disinfection 1 Spray the WL cid ALPRO on to the products Wait 5 minutes for the disinfection effect 2 Proceed to the section 6 3 Sterilization For control unit and foot control 1 Wipe the surface of the products with a cloth moistened with ethanol for disinfection 2 Store the products in ...

Страница 29: ... different from those described in this manual those procedures must be validated by the respective practice or hospital using washer disinfector that conforms to EN ISO 15883 1 Step1 Precleaning cold tap water for 1 minute Step2 Cleaning 0 5 cleaner 55 C for 5 minutes with demineralized water Step3 Rinsing with demineralized water for 1 minute Step4 Thermodisinfection with demineralized water at ...

Страница 30: ...midity ventilation and sunlight The air should be free from dust salt and sulphur Do not heat or cool the product too quickly Rapid change in temperature will cause damage to the product The irrigation tube is for single use product and cannot be autoclaved Do not touch the product immediately after autoclaving as it will be very hot Steam sterilization is recommended for the product The validity ...

Страница 31: ...t the set speed Depress each button and make sure that function corresponding to each button can be confirmed If the foot control does not function properly perform calibration See 7 3 Foot control calibration Remove the foot control battery cover and make sure its O ring is not damaged or worn If damage or wear is seen contact an authorized NSK dealer for replacement Foot control hanger Make sure...

Страница 32: ... FC SET 3 Press 4 Press to select FC CAL 5 Press to select ON 6 Press and confirm that is displayed 7 Fully depress the pedal and all of the buttons on the foot control 8 When 000 0 is displayed calibration is successful Press 9 Make sure that OK is displayed on the LCD display 10 Press twice to end setting mode CAUTION Do not press the enter key when other than 000 0 is displayed If calibration i...

Страница 33: ...menu BLE SET Settings for Bluetooth connection with control unit UNIT SET Settings for control unit FC SET Settings for foot control 3 Press 4 Press to select sub menu See Setting value 5 Press to change the setting value 6 Press to finalize the setting value To change other sub menu setting items repeat procedure from step 4 to 6 7 Press to return to main menu selection screen To change other mai...

Страница 34: ... 10 TS LV Touch sensor sensitivity level When sensitivity is poor such as when using barrier film or surgical gloves 1 3 Larger value More sensitive 1 CL LV1 Coolant solution flow level per display 1 100 20 CL LV2 1 100 40 CL LV3 1 100 60 CL LV4 1 100 80 CL LV5 1 100 100 F RESET Initializing settings When display switches from off to on press the enter key to restore settings to factory settings F...

Страница 35: ...only when FC MODE is changed from AUT to FC See 5 4 Sleep mode OFF 5m 10m 15m 20m 30m 45m 60m 5m CAUTION When setting values are changed press the enter key to finalize If you press the SPEED key TORQUE key or Cancel key without finalizing with the Enter key or if you turn the power off setting details will not be applied NOTICE Initializing settings returns UNT SET in setting mode and program set...

Страница 36: ...iring is successful when a beep sounds and OK is displayed on the LCD display Make sure battery and icons below are displayed and the device is connected 5 Press twice to end setting mode CAUTION If pairing cannot be accomplished replace the batteries with new ones Pairing may not be possible if something is obstructing the signal between the foot control and control unit NOTICE Paring can be done...

Страница 37: ...T 3 Press 4 Press to select BUT SET 5 Press to change setting value See Setting values of foot control button 6 Press Press each time to select the buttons to which functions are assigned in the order of Left button Center button Right button Left button 7 Press twice to end setting mode Factory settings Left Button Center Button Right Button 1 2 3 ...

Страница 38: ...ng up Torque setting down 8 Torque setting up Torque setting fast forward to up direction 9 Torque setting down Torque setting fast forward to down direction A Coolant solution flow level selection up Coolant solution flow level selection 0 no coolant solution flow B Program number selection up Implant system selection up C Implant system selection up Implant system selection down D Motor LED brig...

Страница 39: ...4 Press to set the maximum rotation speed When rotating displays actual speed When stopped displays maximum speed set Beep sounds when upper or lower limit is reached 5 Press to set torque upper limit 20 1 Reduction contra with rotation speed of 100min 1 or less only Stops once at 50N cm If setting to greater than 55N cm press again Beep sounds when upper or lower limit is reached No display when ...

Страница 40: ... choose program numbers that you want to skip 2 Press to set the minimum rotation speed 3 Press again to display on the LCD display 4 Press and hold more than 1 second until it beeps to memorize Canceling the program skip function 1 Press to choose program numbers that you want to cancel the skip function 2 Press to set a speed other than 3 Press and hold for more than 1 second until it beeps to m...

Страница 41: ...he motor cord If the error cannot be eliminated request repair Make sure to attach a protection plug when cleaning in a washer disinfector E4 Control unit interior overheating error Overheating by extended use under heavy load Use immediately after the control unit is placed at high temperature such as inside a car under the blazing sun or in a locker exposed to direct sunlight Allow it to cool do...

Страница 42: ...ficient distance between the tip of Osseo 100 and the electronic equipment If the error cannot be eliminated request repair E14 External terminal error OS of external terminal is not supported Failure of the external terminal Check the supported OS in the application Also reinstall the application If the error cannot be eliminated request repair 9 2 Problems and solutions When a problem is detecte...

Страница 43: ... used for a long period of time See 7 3 Foot control calibration and calibrate the foot control Malfunction of control unit or foot control If the problem is not solved by checking foot control batteries or foot control connection status system repair is required COM ERR FC is displayed Foot control not connected Press the Cancel key to cancel the error After confirming that nothing is blocking th...

Страница 44: ...he automatic connection again See the Osseo 100 manual and try the pairing again If this does not resolve the issue please contact an authorized NSK dealer BATTERY FC is displayed Foot control battery is low Depress the speed control pedal of the foot control or press the Cancel key to cancel the error Replace the batteries If this does not resolve the issue please contact an authorized NSK dealer...

Страница 45: ...n 10 2 Spare parts list Model Remarks AC Power Cord U260414 Coolant Solution Hanger Post U370152 FC 81 Z1401001 Foot Control with Hanger Battery Cover Z1401068 For Foot Control SGL80M Y1004211 Optic motor with motor cord SG80M 2 0m Y1004212 Non optic motor with motor cord Protection Plug 10001595 O Ring D0312457102 For protection plug O Ring D0312074080 For micromotor Tube Holder E1198105 For micr...

Страница 46: ...ilization cassette iCart Duo S9090 For installation of Surgic Pro2 and VarioSurg 3 and accessories PANA SPRAY Plus Z182100 For high and low speed handpieces 10 4 Compatible terminals Supported OS iOS Compatible models iPad 5th generation iPad 6th generation iPad 7th generation iPad 8th generation iPad Pro 12 9 inch 3rd generation iPad Pro 11 inch iPad Pro 12 9 inch 4th generation iPad Pro 11 inch ...

Страница 47: ...t 1 1 kg with hanger Temperature Humidity Atmospheric pressure Use Environment 0 40 C 32 104 F 30 75 RH 700 1 060 hPa Transportation and Storage Environment 10 50 C 14 122 F 10 85 RH 500 1 060 hPa No moisture condensation in the control unit Use outside of these limits may cause malfunction Medical instruments that can be combined with the product NSK VarioSurg 3 NSK Osseo 100 ISO 3964 EN ISO 3964...

Страница 48: ...ith air or with oxygen or nitrous oxide Mode of operation Non continuous operation 11 4 Operation principle Power is supplied to the control unit by operations on the foot control This makes the motor run and the bur attached to the handpiece rotate 11 5 Warranty NSK products are warranted against manufacturing errors and defects in materials NSK reserves the right to analyze and determine the cau...

Страница 49: ...ice This product can be sterilized in a steam sterilizer at 135 C This product can be cleaned using washer disinfector EOG sterilization Single use only Do not reuse Use by date Batch code Do not use if package is damaged and consult instructions for use Do not resterilize Manufacturer Authorized representative in the European Community Battery cover close Battery cover open Keep dry Handle with c...

Страница 50: ...l H L 1 1 5 2000 1200 F F 20 1 3 3 H 2 6 2000 25 45 F F 3 3 3 7 2000 25 50 F R 3 3 4 8 1600 25 20 F F 3 0 2 1 5 2000 800 F F 20 1 3 3 H 2 6 800 25 45 F F 3 3 3 7 800 25 50 F R 3 3 4 8 800 25 20 F F 3 0 3 1 5 800 400 F F 20 1 3 3 H 2 6 600 15 35 F F 3 3 3 7 500 15 40 F R 3 3 4 8 400 15 35 F F 3 0 4 1 5 800 300 F F 20 1 3 3 H 2 6 600 15 35 F F 3 3 3 7 500 15 40 F R 3 3 4 8 400 15 35 F F 3 0 5 1 5 14...

Страница 51: ...ht level H L 7 1 5 1400 1000 F F 20 1 3 3 H 2 6 1400 15 35 F F 3 3 3 7 1400 15 40 F R 3 3 4 8 1200 15 35 F F 3 0 8 1 5 800 600 F F 20 1 3 3 H 2 6 600 15 35 F F 3 3 3 7 600 15 40 F R 3 3 4 8 600 15 35 F F 3 0 Example Implant system number 3 Program number 5 Maximum rotation speed 400 Torque upper limit Rotation direction F Gear ratio 20 1 Coolant solution flow level 3 Light level H ...

Страница 52: ...ic discharge ESD IEC 61000 4 2 EN 61000 4 2 8kV contact 2 4 8 15kV air 8kV contact 2 4 8 15kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 EN 61000 4 4 2kV for power supply lines 1kV for input output lines 2kV for power supply lines 1kV for input output line...

Страница 53: ...ge b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cor...

Страница 54: ...power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 1 2 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation appli...

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