NSK Primado 2, Operation Manual

Page 1: ...Total Surgical System Motor OM SE0029E 001 ...

Page 2: ...ines so that you can use it for many years to come through a correct use Keep this Operation Manual within easy reach Precautions for handling and operation Class Degree of Risk DANGER Hazard that could result in personal death or serious injury if the safety instructions are not correctly followed WARNING Hazard that could result in serious injury or damage to the device if the safety instruction...

Page 3: ...o whom a flammable anesthetic agent dinitrogen monoxide has been administered Never disassemble or modify the product Personal injury electric shock or fire may result WARNING When operating the product always consider the safety of the patient This is a medical system do not allow anybody to use it other than surgeons who are familiar with the procedures Use this system in accordance with its int...

Page 4: ...neration is detected stop use and contact your dealer Do not subject this product to strong impacts such as dropping it on the floor Personal injury abnormal heating and fire may result caused by the internal damage Do not disconnect the Motor Cord from the Motor It may cause failure Do not clean the product with solvents such as thinner or benzine solution Discoloration or deformation may result ...

Page 5: ...or P200 HMH P200 SMH P200 BMH P200 HMH HS P200 SMH HS P200 BMH HS Motor with Hand Control 1 Hand Switch 2 Adjustable Lever 3 Safety Lock 4 Motor Cord Plug Motor with Hand Control only 2 1 3 ON OFF 4 1 Part Names ...

Page 6: ...5 1 2 Wire Pin Driver P200 WPD 1 Trigger Upper A 2 Safety Lock 3 Trigger Lower B 4 Mounting Removal Button 5 Motor Cord Plug 2 3 1 4 5 ...

Page 7: ...ut with a straight movement Fig 1 Refer to the Operation Manuals of Primado2 and Attachments Handpieces CAUTION There are two Motor Connectors By connecting two Motors to the two connectors you can select the one you want to use by the Motor Select Button of the Control Unit However both Motors cannot be operated simultaneously The selected Motor can be confirmed in the Main Panel of the Control U...

Page 8: ... Control Unit easily do not insist Deformation or cracks might occur A foreign substance might be obstructing the connection or the connection portion might be deformed Contact your dealer Whenever connecting disconnecting the Motor with Hand Control and Wire Pin Driver be sure to turn OFF the Control Unit When connecting disconnecting the Motor do not rotate the Motor Cord Plug Otherwise the insi...

Page 9: ...ng sound to connect firmly Removing Pull out the Attachment Handpiece from the Motor straight Fig 2 Attachment Handpiece Motor Alignment Hole Alignment Pin Whenever mounting removing the Attachment Handpiece be sure to switch OFF the Safety Lock of the Wire Pin Driver Motor with Hand Control Prior to mounting removing the Attachment Handpiece remove the Bur or Blade Otherwise injury might occur Af...

Page 10: ...ments Handpieces Mounting 1 Push the Attachment Handpiece into the Motor straight 2 Rotate the Attachment Handpiece rightward or leftward so that the Alignment Pin of the Motor Fig 4 matches the hole of the Attachment Handpiece with a clicking sound to connect firmly 3 Tighten the Removal Ring of the Attachment Handpiece manually to fix it firmly Removing Loosen the Removal Ring and pull out the A...

Page 11: ...ieces Mounting Insert the Attachment straight into the Motor until it clicks Removing Pull the Attachment straight out while pressing the Mounting Removal Button of the Motor Fig 5 Motor Attachment Handpiece Mounting Removal Button ...

Page 12: ...UH 3LQ ULYHU VOLGH VPRRWKO 4 Depress the Pedal of the Foot Control to check for any abnormal vibration noise or heating in the Motor Check in the Main Panel of the Control Unit that the rotational speed can reach the maximum speed you have set 5 Check that Forward Reverse and Oscillate P200 WPD only Modes operate normally 6 Mount the Attachment Handpiece to the Motor to check their secure connecti...

Page 13: ...ontrol If operating the Motor only with the Motor with Hand Control and the Primado2 Wire Pin Driver it is recommended to disconnect the Foot Control from the Control Unit Alternatively set the Foot Control to OFF by the Foot Control ON OFF Button to disable the Foot Control Refer to the Operation Manuals of Primado2 and Attachments Handpieces The Hand Switch of the Motor with Hand Control and the...

Page 14: ...leased there is a short alarm sound When the Reverse Mode has been selected the Bur rotates in reverse During the reverse rotation in this Mode the alarm continues to sound OFF ON Fig 6 When operating the Safety Lock be sure to hold the lever with your finger If operating it without holding the lever the lever might inadvertently be depressed when the Safety Lock is being turned ON OFF thereby tri...

Page 15: ... Handpiece rotates forward When depressing the Trigger or releasing it a short alarm sounds When depressing the upper Trigger A the Attachment Handpiece rotates in reverse During the reverse rotation the alarm continues to sound When depressing both the upper A and lower B Triggers simultaneously the forward and reverse rotations of the Attachment Handpiece are repeated alternately i e the rotatio...

Page 16: ...tarts rotating in reverse During this reverse rotation the alarm continues to sound Trigger Upper A Lower B Upper and Lower depressed simultaneously A B Rotation Direction Reverse Rotation Forward Rotation Oscillation Forward and reverse rotations are repeated alternately Fig 8 The Wire Pin Driver operates in the rotation direction set not by the Control Unit but by the Wire Pin Driver CAUTION Ped...

Page 17: ...he pre determined function For any further information refer to 6 4 Setting Up the Foot Control in Primado2 Operation Manual Fig 9 Before using the Foot Control Button be sure to confirm what function is assigned to that Button in the Sub Panel CAUTION Foot Control Button Blue Foot Control Button Silver Foot Control Button Green Pedal ...

Page 18: ...the Motor Cord thoroughly using a lint free cloth moistened with neutral detergent for medical use or a non metallic brush 2 Remove the detergent solution using a lint free cloth moistened with distilled deionized or demineralized water Perform cleansing and sterilization after every use Be sure to clean and sterilize the Motor after use Unremoved blood may result in product failure due to the int...

Page 19: ... water c Thermal disinfecting at 93 C for 5 minutes using distilled deionized or demineralized water d Drying at least 10 minutes Prior to use of a Thermo Disinfector read the Thermo Disinfector Operation Manual carefully Do not use a chlorinated cleaner Do not clean the Motor by an ultrasonic cleaning apparatus After cleaning and prior to sterilization check the Motor in the same method as in Ste...

Page 20: ...e verify the validity of sterilization in the following conditions The sterilization parameters are indicated for sterilization and immediate use only Do not soak the Motor into water or failure might occur The Motor is not suitable for EOG sterilization Sterilize the Motor after each patient Do not clean the Motor by a washer sterilizer The Motors do not require lubrication Never lubricate them W...

Page 21: ...ents has been attached The Twist Collet on the Attachment Handpiece is OPEN After inserting the Bur fasten the Twist Collet Turn it in the direction of The bearing has seized Foreign substance inside the bearing The bearing is worn out Contact your dealer Abnormal heating during rotation Continuous use over a long period Stop operating the Attachment Handpiece and Motor immediately Wait until the ...

Page 22: ...ty Lock is OFF Contact your dealer Rotation when the Hand Switch is not depressed The Hand Switch cannot get back to specified position due to foreign substances No rotation even after the Twist Collet of the Attachment Handpiece has been fastened The bearing has seized Foreign substances are obstructing the bearing Symptoms Causes Points of checking Countermeasures Vibration noise bur run out The...

Page 23: ...o foreign substances Symptoms Causes Points of checking Countermeasures Abnormal heating during rotation Continuous use over a long period Stop operating the Attachment Handpiece and Motor immediately Wait until the Attachment Handpiece and Motor cool down before continuing to operate The bearing has seized Foreign substance inside the bearing The bearing is worn out Contact your dealer Vibration ...

Page 24: ...s use over a long period Stop operating the Attachment Handpiece and Motor immediately Wait until the Attachment Handpiece and Motor cool down before continuing to operate The bearing has seized Foreign substance inside the bearing The bearing is worn out Contact your dealer Vibration noise bur run out The bearing has seized Foreign substance inside the bearing The bearing is worn out ...

Page 25: ...Ø18 L99 7mm Ø19 3 L117 5mm Ø18 L100 4mm Ø20 2 L101 8mm W75 5 D28 0 H141 3 Weight 361g 390g 305g 340g 302g 359g 790g Operation time 3 min ON 10 min OFF 3 min ON 10 min OFF 1 min ON 15 min OFF 1 min ON 10 min OFF Length of Motor Cord 3 5 m Temperature Humidity Atmospheric pressure Use Environment 0 40 C no condensation 30 75 RH 700 1 060hPa Storage and Transportation Environment 10 50 C 10 85 RH 500...

Page 26: ...ons below For such repair requests please contact your dealer Guarantee period One year Ř Q WKH IROORZLQJ FDVHV WKH UHSDLU KDV WR EH SDLG IRU HYHQ LI LW LV ZLWKLQ WKH JXDUDQWHH SHULRG Fault and damage caused by misuse or inappropriate repair or modification Fault and damage caused during transit or dropping the product after it was purchased Fault and damage attributable to fire earthquake floodin...

Page 27: ...ee Step 5 Cleaning Sterilization This product can be washed via Thermo Disinfector Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment Rx Only Caution U S Federal law restricts this device to sale by or on the order of a licensed physician 10 Symbols ...

Page 28: ...Voltage fluctuations flicker emissions EN IEC61000 3 3 Compliance Group㸯 Class B Not Applicable Not Applicable Electromagnetic environment guidance The Primado2 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Primado2 is suitable for use in all establishments including domestic estab...

Page 29: ...for power supply lines 1kV for input output 1kV line s to line s 2kV line s to earth 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 secs 3A m Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power...

Page 30: ...d to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Primado2 b Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m Immunity test Conducted RF EN IEC61000 4 6 Radiated RF EN IEC61000 4 3 EN IEC60601 test level 3Vrms 150 kHz to 80MHz 3V m 80MHz to 2 5 GHz Compliance level 3Vrms 3V m E...

Page 31: ...ssions CISPR11 Electrostatic discharge ESD Electric fast transient burst Surge Voltage dips short interruptions and voltage variations on power supply input lines Power frequency 50 60Hz magnetic field Radiated RF Radiated RF Class B Group 1 EN IEC61000 4 2 EN IEC61000 4 4 EN IEC61000 4 5 EN IEC61000 4 11 EN IEC61000 4 8 EN IEC61000 4 6 EN IEC61000 4 3 ...

Page 32: ...ot listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all...

Page 33: ...Please read this Operation Manual carefully before use and file for future reference 2015 05 20 002 Specifications are subject to change without notice ...