Storz UNIDRIVE Select Instructions For Use Manual
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Storz UNIDRIVE Select Instructions For Use Manual

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UNIDRIVE Select

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Summary of Contents for Storz UNIDRIVE Select

  • Page 1 Instructions for use UNIDRIVE Select...
  • Page 2 02-2022 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

  • Page 3: Table Of Contents

    5.2 Setting up the product ..................... 21 5.3 Connecting the product ....................21 5.4 Putting the product into operation  .................. 23 5.5 Putting the pump into operation ..................25 6 Application ..........................28 6.1 Selecting the handpiece  ....................28 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 4 9.7 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product  ..............58 10 Errors and messages ........................ 60 10.1 Troubleshooting ....................... 60 10.2 Software messages  ......................60 11 Overview of mitigating warnings  ....................61 12 Subsidiaries  ..........................62 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 5: General Information

    ð Interim result of an action Step 2 ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Lists Numbered list – Unnumbered list, 1st level Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 6: Description Of Warning Messages

    Designates a possibly harmful situation. If this is not avoided, the products could be damaged. 1.6 Abbreviations Abbreviation Explanation Computed tomography Ears, nose and throat medicine Magnetic resonance tomograph NEURO Neurosurgery RFID Radio frequency identification SPINE Vertebral column OMFS Oral and maxillofacial surgery Central nervous system Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 7: Normal Use

    Several minutes to several hours a day Place of installation Positioning on a level, vibration-free surface Mobility – Can be moved if placed on a cart. – Can be swiveled if installed on ceiling supply units. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 8: Safety And Warning

    IEC or ISO standards. Furthermore, all configurations must comply with the requirements for medical electrical systems. If additional devices are connected to medical electrical equipment, a medical system is configured that must satisfy the requirements for medical electrical Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 9: Risk Of Explosion And Fire

    All electrical installations of the operating room in which the device is connected and used must meet the applicable IEC standards. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity.

  • Page 10: Damage Due To Ingress Of Liquid In Electrical Components

    Do not open the product. Have servicing carried out by KARL STORZ or a company authorized by KARL STORZ. Failure to do so will void the guarantee. Do not touch the output jacks of the product and the patient at the same time during use Always pull out the mains plug before carrying out any cleaning and maintenance work.

  • Page 11: Failure Of Products

    Patients, users, and third parties may be injured. Do not use the product if the touch screen is defective. Do not tap the touch screen in several places at the same time. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 12: Product Description

    4 Product description 4.1 Description of operation The KARL STORZ motor system UNIDRIVE Select is universally applicable in the ENT, NEURO and SPINE application areas due to the use of separate brushless high-performance electronic motors or brushless high-performance electronic motors integrated in the handpiece.

  • Page 13: Possible Combinations

    INTRA micro motor 80k 20261033 Two-pedal footswitch, one-stage UF201 Two-pedal footswitch, one-stage, wireless UF201W DRILLCUT-X® II spine handpiece 28712050 DrillCut-X II shaver handpiece 40712050, 40712055 with shaver blades 412xx, 413xx and sinus burr 413xx Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 14: Technical Data

    80,000 rpm (±10%) Start-up maximum speed 80,000 rpm (±10%) Rotation mode Rotation High-Speed Drill 80k Minimum speed 2,000 rpm (±10%) Maximum speed 80,000 rpm (±10%) Start-up maximum speed 80,000 rpm (±10%) Rotation mode Rotation Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 15 Start-up maximum speed 12,000 rpm (±10%) Rotation mode Rotation DrillCut-X II-35 – shaver Minimum speed 1,500 rpm (±10%) Maximum speed 10,000 rpm (±10%) Start-up maximum speed 10,000 rpm (±10%) Rotation mode Oscillation Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 16 20,000 rpm (±10%) Start-up maximum speed 2 15,000 rpm (±10%) Rotation mode Oscillation Dermatomes Minimum speed 1,000 rpm (±10%) Maximum speed 8,000 rpm (±10%) Start-up maximum speed 8,000 rpm (±10%) Rotation mode Oscillation Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 17: Symbols Employed

    Consult the printed or electronic instructions for use Note for the user to consult the instructions for use for important cau- tionary information such as warnings and precautions. Fragile, handle with care Keep dry Temperature limit Humidity limit Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 18: Symbols On The Product

    EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. 4.5.2 Symbols on the product Symbol Meaning Follow the instructions for use.

  • Page 19: Symbols On The Type Plate

    EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Decla- ration of Conformity, which can be requested from KARL STORZ. 4.5.4 Symbols on the user interface Symbol...

  • Page 20: Ambient Conditions

    -15 °C ... +60 °C (5 °F ... 140°F) Relative humidity 5 – 85 % (non-condensing) Air pressure 600 – 1,080 hPa Average life cycle 5 years Conditions of use Temperature 10 °C ... 40 °C (50 °F...104 °F) Relative humidity 30 – 75 % Air pressure 700 – 1,080 hPa Max. operating altitude 3,000 m Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 21: Preparation

    Set the product down on a horizontal, flat surface or a video cart. Install the product out of reach of patients. 5.3 Connecting the product Connect the potential equipotential cable. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 22 Connect the Ethernet cable for combination with ENDOMAT SELECT (UP220). Connect the footswitch cable to the front or rear of the device. To do this, align the red dot on the cable with the red dot on the footswitch socket. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 23: Putting The Product Into Operation

    To avoid damaging the cables, pull on the plug when removing the cables. 5.4 Putting the product into operation ü The footswitch is connected. ü An application instrument is connected. ü The ENDOMAT SELECT (UP220) is connected. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 24 ð If no application instrument or motor is connected, the following start screen appears: ð If an application instrument/motor is connected, a screen appears prompting you to select the handpiece. For the DrillCut-X II-35, for example, this appears: Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 25: Putting The Pump Into Operation

    Tap the Arrow symbol again to collapse the handpiece selection. ð The selected handpiece appears as a presetting when the handpiece selection is expanded again. If a KARL STORZ pump is not being used, close the message. ð The following message appears: Put the pump used into operation.
  • Page 26 ü The UNIDRIVE SELECT is switched on and connected to the ENDOMAT SELECT (UP220). Install the tubing set on the ENDOMAT SELECT (UP220). Make sure that the pump tubes are not crushed. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 27 Connect the tubing ends with the irrigation bag (puncture needle) or with the irrigation connector on the instrument (LUER lock). To remove the tubing set, turn the pump lever clockwise to the 9 o'clock position. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 28: Application

    Connect the motor, see chapter Connecting the product [p. 21]. ð The following screen appears: Tap on the Arrow to expand the handpiece selection. Select the High-speed handpiece to call up the high-speed burr selection. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 29: Drillcut-X Ii-35

    Set the speed, see chapter Setting the speed [p. 33]. 6.1.2 DrillCut-X II-35 Connect the motor, see chapter Connecting the product [p. 21]. ð The following screen appears: Tap on the Arrow to expand the handpiece selection. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 30 Application Select the desired handpiece. ð The following screens appear: Set the speed, see chapter Setting the speed [p. 33]. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 31: Intra Motor

    Connect the motor, see chapter Connecting the product [p. 21]. ð The following screen appears: Tap on the Arrow to expand the handpiece selection. Select the Micro saws to call up the saw selection. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 32: Micro Ear Burr

    Set the speed, see chapter Setting the speed [p. 33]. 6.1.5 Perforator Connect the motor, see chapter Connecting the product [p. 21]. ð The following screen appears: Set the speed, see chapter Setting the speed [p. 33]. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 33: Setting The Speed

    ð The handpiece screen appears with the maximum speed value: Tap the speed value. ð The Minus button appears: Tap the Minus button to reduce the speed value. ð The Plus button appears: Set the desired speed value using the buttons. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 34: Changing The Direction Of Rotation

    Alternatively, press the footswitch button briefly, see chapter Operating the footswitch [p. 36]. 6.4 Selecting the motor connection Two application instruments operated within various speed ranges can be connected up to the device. You can switch between the motor connections during application. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 35: Setting The Irrigation Flow

    Tap on the irrigation flow value on the ENDOMAT SELECT screen. ð The value appears as a slide bar: Move the slide bar to set the desired value. Alternatively, set the irrigation flow using the footswitch, see chapter Operating the footswitch [p. 36]. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 36: Operating The Footswitch

    Setting the pedal control [p. 39]. Press the right pedal. ð This speed varies depending on the pedal position. ð The handpiece is started and the pump runs with the defined irrigation flow rate. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 37: Settings

    ð The Device info screen appears: Browse back through the screen with the Arrow. ð The Settings screen appears. 6.7.2 Setting the language The language is set to English as the default. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 38: Setting The Brightness And Volume

    In the Settings screen, tap on the Further settings sub-menu. ð The Further settings screen appears: Adjust the Brightness and the Volume with the Plus and Minus buttons. Browse back through the screen with the Arrow. ð The Settings screen appears. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 39: Calling Up The Event Log

    Tap on the desired line to call up the entry on the event. 6.7.5 Setting the pedal control The pedal control determines how the set irrigation flow behaves when the left pedal is pressed briefly. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 40: Setting The Motor Stop Behavior

    Browse back through the screen with the Arrow. ð The Settings screen appears. 6.7.7 Service The Service area is password-protected and can only be accessed by the KARL STORZ technical customer service or authorized persons. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 41: Switching Off The Product

    Application 6.8 Switching off the product Switch off the product with the stand-by button. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 42: Maintenance, Servicing, Repairs, And Disposal

    Request a KARL STORZ service technician for service work. ü The product is switched off. ü The power cord is disconnected from the product. Remove the screw inserts on the power fuse holder with a screwdriver. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 43 Insert the new fuse. Only use fuses with the same fuse ratings, see chapter Technical data [p. 14]. Introduce the screw inserts into the power fuse holder again. Connect the power supply again. Switch on the product and check that it is working correctly. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 44: Safety Inspection In Accordance With Iec 62353

    Document the results of the safety test. 7.4 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries).

  • Page 45: Disposing Of The Product

    The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE). Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for the proper disposal of this product. The product must be disposed of in accordance with the applicable national laws and regulations at a suitable collection point for the reprocessing of electrical and electronic equipment.

  • Page 46: Accessories And Spare Parts

    Micro ear burr, 12,000 rpm 460000 INTRA micro motor 80k 20261033 High-speed micro motor, large 20362033 High-speed micro motor, small 20363033 DrillCut-X II-35 40712035 DrillCut-X II-35 N 40712535 DrillCut-X II 40712050 DrillCut-X II N 40712055 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 47 High-speed diamond burr, Ø 1.8 mm, 70 mm, 50,000 rpm 340218 High-speed diamond burr, Ø 2.3 mm, 70 mm, 50,000 rpm 340223 High-speed diamond burr, Ø 2.7 mm, 70 mm, 50,000 rpm 340227 High-speed diamond burr, Ø 3.1 mm, 70 mm, 50,000 rpm 340231 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 48 High-speed diamond burr, rough, Ø 3.5 mm, 70 mm, 50,000 rpm 340335 High-speed diamond burr, rough, Ø 4.0 mm, 70 mm, 50,000 rpm 340340 High-speed diamond burr, rough, Ø 5.0 mm, 70 mm, 50,000 rpm 340350 High-speed diamond burr, rough, Ø 6.0 mm, 70 mm, 50,000 rpm 340360 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 49 High-speed diamond burr, Ø 3.1 mm, 95 mm, 80,000 rpm, sin- 360231S gle-use product, sterile High-speed diamond burr, rough, Ø 4.0 mm, 95 mm, 80,000 360340S rpm, single-use product, sterile High-speed diamond burr, rough, Ø 5.0 mm, 95 mm, 80,000 360350S rpm, single-use product, sterile Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 50 High-speed diamond burr, rough, Ø 4.0 mm, 125 mm, 80,000 360340M rpm, single-use product, sterile High-speed diamond burr, rough, Ø 5.0 mm, 125 mm, 80,000 360350M rpm, single-use product, sterile High-speed diamond burr, extra rough, Ø 4.7 mm, 125 mm, 360347M 80,000 rpm, single-use product, sterile Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 51 High-speed craniotome burr, medium, 15 mm, 80,000 rpm, sin- 362640M gle-use product, sterile, in combination with craniotome attach- ment (362647) High-speed craniotome burr, long, 25 mm, 80,000 rpm, single- 362640L use product, sterile, in combination with craniotome attachment (362648) Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 52 5. – Straight – Curved – Curved without serrated jaws – Single serrated – Double serrated Sinus burr (applied parts), disposable (sterile): Article number, see cata- – Oblong – Round burr Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 53: Spare Parts

    High-speed micro motor without cable 20362133 Cable for high-speed micro motor, large 20362233 High-speed micro motor without cable 20363133 Cable for high-speed micro motor, small 20363233 INTRA motor 80k, without cable 20261133 INTRA Connecting Cable 20261233 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 54: Electromagnetic Compatibility

    Guidelines and manufacturer’s declaration – electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user of the product should make sure that it is used in such an environment. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 55 Immunity test acc. 3 V/m 80 MHz to 3 V/m 80 MHz to to IEC 61000-4–3 2.7 GHz 2.7 GHz for radiated, ra- * Refer to Table 2 for wireless proximity RF field test levels Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 56 4, 25, UMTS 2450 2400 – 2570 Bluetooth, Pulse modula- WLAN 802.11 tion b/g/n, 217 Hz RFID 2450, LTE Band 7 5240 5100 – 5800 WLAN 802.11 Pulse modula- tion 5500 217 Hz 5785 Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 57 = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz Interferences may occur in the vicinity of equipment marked with the following symbol: Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 58 The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the product as recommended below, according to the maximum output power of the communications device. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 59 Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. The product was tested for compatibility with HF surgical devices in accordance with IEC 60601-2-2 Appendix BB. Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 60: Errors And Messages

    Motor not supported Motor cannot be used with – available license Motor defective Connector problems Contact Service Product defective Motorboard defective Contact Service Footswitch defective Pedal defective Contact Service Pedal cannot be calibrated Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 61: Overview Of Mitigating Warnings

    WARNING No modification of this equipment is allowed. WARNING Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...

  • Page 62: Subsidiaries

    Phone: +358 (0)96824774, Fax: +358 (0)968247755 E-mail: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 E-mail: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR...
  • Page 63 E-mail: info-az@karlstorz.com No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
  • Page 64 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...

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