Arthrex Highspeed 200 User Manual
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Arthrex Highspeed 200 User Manual

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DrillSaw Highspeed 200™
User's Guide
The Arthrex DrillSaw Highspeed 200™ User's Guide provides
safety operation information for all components of the
Arthrex DrillSaw Highspeed 200, including accessories. All
operating personnel must read this User's Guide thoroughly
prior to using this system and follow all safety warnings,
cautions, and precautions.
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-(800) 934-4404
www.arthrex.com
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: +49 89 909005-0
www.arthrex.de
DFU-0225-2
Revision 0
September, 2018
© 2016 Arthrex, Inc. All rights reserved

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Summary of Contents for Arthrex Highspeed 200

  • Page 1 DrillSaw Highspeed 200™ User’s Guide The Arthrex DrillSaw Highspeed 200™ User’s Guide provides safety operation information for all components of the Arthrex DrillSaw Highspeed 200, including accessories. All operating personnel must read this User’s Guide thoroughly prior to using this system and follow all safety warnings, cautions, and precautions.
  • Page 2 This page intentionally left blank...

  • Page 3: Table Of Contents

    Table of Contents 1.0 General Warnings and Safety Notices - Read This First ..... 1 Important Safety Conventions ................1 Symbols Definition ..................... 4 Shipping, Unpacking, and Warranty Information ..........6 0 Product Description and Intended Use ..........7 Product Description .................... 7 Intended Use ......................
  • Page 4 Table of Contents 4.10 AR-200H Handle ....................29 4.11 Screen Navigation Overview ................30 4.12 General Settings ....................31 Changing the Date ....................31 Changing the Time ....................32 Changing the Contrast ..................32 Changing the Volume ..................32 Reset Factory Setting ..................33 Exit setting ......................33 Factory Settings (P1-P6) ..................34 4.13 AR-200 Settings ....................
  • Page 5 Table of Contents Technical Support................48 Additional Technical Information ..............48 Troubleshooting ................49 10.1 Troubleshooting Interference with Other Devices ..........50 Repair Policy ..................51 Warranty ................... 52 End of Life, Environmental Directives ..........53 Electromagnetic Emissions ............... 54 List of Figures Figure 1 Front Panel of Console ......................
  • Page 6 Table 24 Guidance and Manufacturer's Statement - Electromagnetic Immunity ....... 55 Table 25 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ... 56 Table 26 Attachments for AR-200M motor for DrillSaw Highspeed 200 ........57 DFU-0225-2 Rev. 0 Page iv...

  • Page 7: General Warnings And Safety Notices - Read This First

    The DrillSaw Highspeed 200 User’s Guide identifies critical, important, and useful information using these symbols and conventions. 1.1 Important Safety Conventions Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique. W A R N I N G ! WARNING! is the most important safety symbol.
  • Page 8 25. Never use the Arthrex 200 in areas close to strong magnetic fields. 26. Do not place the handpiece drive on the patient. The PRECAUTION! symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction.
  • Page 9 IEC 60320-1 Subclause 3.21, Detachable Power Supply Cords or electrical standards for the designated country where the AR-200C is being used. Contact your Arthrex representative for further information. 3. Avoid positioning the console so that it is difficult to disconnect the coupler or plug from the mains power supply.

  • Page 10: Symbols Definition

    DrillSaw Highspeed 200™ User’s Guide 21. Before starting operation again: Wait until the motor and cable are completely dry. Moisture in the plug or motor can lead to a malfunction. (short circuit). 22. Position the foot control unit, where it cannot be pushed unintended.
  • Page 11 [x] Square brackets that enclose a letter, number or lower-case Roman numeral reference a callout on a line drawing. The section for “Product Features” includes line drawings of products associated with the DrillSaw Highspeed 200. Each line drawing has its own callout system to identify important elements of each product.

  • Page 12: Shipping, Unpacking, And Warranty Information

    Refer also to our General Terms of Business. All defective products will be repaired or replaced at the discretion of Arthrex at no charge. The warranty does not cover damage caused by unlawful use or improper handling of a product.

  • Page 13: Product Description And Intended Use

    0 Product Description and Intended Use 2.1 Product Description The DrillSaw Highspeed 200 is a console driven power tool for orthopedic surgeries. Two different motors can be connected. Only one motor can be used at a time. Both motors can be operated with the foot control unit. The motors will be reused.

  • Page 14: Set Composition

    DrillSaw Highspeed 200™ User’s Guide W A R N I N G ! Misuse may damage the AR-200 and may cause risks and hazards for patients, users and third parties. W A R N I N G ! This device is only for use under the supervision of a trained and licensed physician.
  • Page 15 DrillSaw Highspeed 200™ User’s Guide Accessories for AR-200M motor: All attachments that can be used with AR-200M motor are listed in Table 26 Other optional accessories: OEM06290600 AR-200 - CLIPS (5 PIECES) • OEM06352200 AR-200 - FUSE 250V-T1.6AH • OEM07149200 AR-200 - CLEANING ADAPTER FOR SPRAY CLIP •...

  • Page 16: Product Features

    DrillSaw Highspeed 200™ User’s Guide 2.5 Product Features AR-200C Console: Front View Figure 1 uses a numeric callout system to identify the main elements of the console’s front panel, which are listed and labeled in Table 1. These callouts are referenced throughout this User’s Guide.

  • Page 17: Ar-200C Console: Rear View

    DrillSaw Highspeed 200™ User’s Guide AR-200C Console: Rear View Figure 2 uses a numeric callout system to identify the main elements of the console’s rear panel, which are listed and labeled in Table 2. These callouts are referenced throughout this User’s Guide.

  • Page 18: Ar-200C Console: Main Screen And Iconography

    DrillSaw Highspeed 200™ User’s Guide AR-200C Console: Main Screen and Iconography The console’s Main Screen (Operator display) [2] provides information about the status of the AR-200 programs, speed, torque and coolant settings in real time. Table 3 describes each message or button, cause and explanation when the AR- 200 is in the ready state.

  • Page 19: Foot Control Unit (S-N1)

    DrillSaw Highspeed 200™ User’s Guide 2.5.4 Foot Control Unit (S-N1) Figure 4 uses a numeral callout system to identify the main elements on the foot pedal unit, which are listed and labeled in Table 4. These callouts are referenced throughout this User’s Guide.
  • Page 20 DrillSaw Highspeed 200™ User’s Guide W A R N I N G ! The console, the motors with cable and the footswitch are not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anesthetic substances containing oxygen or nitrous oxide. Z one M is defined as a ”medical environment“...

  • Page 21: Ar-200M, Ar-200M-Iso Motors With Cable

    DrillSaw Highspeed 200™ User’s Guide 2.5.5 AR-200M, AR-200M-ISO Motors with Cable Two different, externally powered motors can be connected to the AR-200C Console AR-200M: Figure 5 AR-200M Motor with AR-300 Attachment Coupling Table 5 AR-200M Motor Elements Motor chuck mechanism...

  • Page 22: Figure 6 Ar-200M-Iso Motor With Iso Saw Attachment Coupling

    DrillSaw Highspeed 200™ User’s Guide The maximum rotational speed of the DrillSaw Mini 300 attachments stated in the User’s Guide DFU-0223-XX can only be reached when the AR-200M motor speed is set to 15,000 rpm on the AR-200C console. Rotational energy: Fast deceleration of the bur can cause the selected torque to be overloaded as a result of the rotational energy stored in the drive system.

  • Page 23: Ar-200Sp Spray Clip

    DrillSaw Highspeed 200™ User’s Guide 2.5.6 AR-200SP Spray Clip Figure 7 AR-200SP Spray Clip Table 7 AR-200SP Spray Clip Elements Coolant tube Clip mechanism Connection for Irrigation pump tubing The Spray Clip can be attached to the AR-200M motor with cable, and leads the irrigation fluid to the tip of the connected burr.

  • Page 24: Technical Specifications

    DrillSaw Highspeed 200™ User’s Guide 0 Technical Specifications 3.1 Console AR-200C Table 8 Console (AR-200C) Specifications Width 256 mm (10 in.) Height 109 mm (4.3 in.) Depth 305 mm (12 in.) Weight 7.0 kg (15.4 lbs.) Maximum flow rate ≥ 90 mL/minute Power supply 110-130 V / 220-240V, 50/60 Hz, 0.1-1.8A / 0.1-0.9A...

  • Page 25: Motor Ar-200M

    DrillSaw Highspeed 200™ User’s Guide 3.2 Motor AR-200M Table 11 Motor AR-200M Specifications Diameter 26.3 mm (1.04 in.) Length 96 mm (3.78 in.) Weight 0.42 kg (0.93 lbs.) Speed 300-15,000 rpm Torque 7 Ncm Length in Cable 3.5 m (137.8 in.) Cleaning Refer to Section 6.0 Cleaning and Disinfecting...

  • Page 26: Safety, Emc, And Regulatory Requirements

    DrillSaw Highspeed 200™ User’s Guide 3.5 Safety, EMC, and Regulatory Requirements Parameter Parameter Value System Classification IEC 60601-1 Class II (protection against electric shock) FDA class Class I exempt EU class Class IIa Health Canada Class Class 2 Safety Certifications...

  • Page 27: Setup

    AC mains outlet. Please use the appropriate plug and a reliable ground conductor. Arthrex supplies separate power cords for the U.S. and Europe CEE 7/7 with the AR-200. Contact your Arthrex representative if you need a power cord that must meet the electrical standards of another country.

  • Page 28: Replacing The Fuses

    5. Ensure that the fuse holder is fully seated and that the tabs snap back. Always use fuses with the correct values to avoid allowing overcurrent to enter the system. Only use Arthrex original fuses. An incorrect fuse may increase the risk of electrical shock or fire hazard.

  • Page 29: Basic Setup Procedure For The Ar-200

    DrillSaw Highspeed 200™ User’s Guide To determine if the AR-200 is causing interference with other devices, power the AC mains power switch [11] OFF, and then ON again. Try to correct the interference by following one or more of these measures: Reorient or relocate the receiving device.

  • Page 30: Motor Detection

    W A R N I N G ! Use ONLY Arthrex approved accessories. Other accessories may result in increased emissions or decreased immunity of the system. Contact your Arthrex representative for a complete list of accessories. DO NOT modify any accessory.

  • Page 31: Connecting And Removing Attachments To The Ar-200M Motor

    DrillSaw Highspeed 200™ User’s Guide 4.7 Connecting and Removing Attachments to the AR-200M Motor These instructions describe the procedure for connecting an attachment to the AR-200M motor. Figure 9 Connecting and removing an attachment Table 15 Connecting and removing an attachment...

  • Page 32: Pump Tubing

    DrillSaw Highspeed 200™ User’s Guide 4.8 Pump Tubing These instructions describe the setup of the AR-200 irrigation pump tubing. Figure 10 Irrigation Pump Tubing Setup Table 16 Irrigation Pump Tubing Configuration Install the bag and spike the bag with the irrigation pump tubing...
  • Page 33 DrillSaw Highspeed 200™ User’s Guide Sterile irrigation pump tubing is supplied with the equipment. These irrigation pump tubing is disposable and must be discarded after each use. Please note the expiration date and the relevant regulations for disposal of irrigation pump tubing.

  • Page 34: Ar-200Sp Spray Clip

    DrillSaw Highspeed 200™ User’s Guide 4.9 AR-200SP Spray Clip These instructions describe the setup of the AR-200M with the AR-200SP Spray Clip Figure 11 Connection of AR-200SP Spray Clip to the Motor AR-200M Table 17 One-Piece Tubing Configuration Attach the Spray Clip to the motor...

  • Page 35: Ar-200H Handle

    DrillSaw Highspeed 200™ User’s Guide 4.10 AR-200H Handle These instructions describe the setup of the AR-200M with the AR-200H Handle Figure 12 Connection of AR-200H handle to the AR-200M motor Table 18 AR-200H handle connection to AR-200M motor Attach the handle to the AR-200M motor cable Pay attention to the orientation.

  • Page 36: Screen Navigation Overview

    DrillSaw Highspeed 200™ User’s Guide 4.11 Screen Navigation Overview Figure 13 Overview of different screens Main Screen Enter: Exit: Simultaneously Press MINUS press the shift button Choose Settings Screen buttons ▲ and ▼ for 2 seconds [1] Enter: Enter: highlighted...

  • Page 37: General Settings

    DrillSaw Highspeed 200™ User’s Guide Press the MINUS button [3] to move from the Choose Setup Screen to the main screen. Highlight the EXIT button: and press PLUS or MINUS to move from the General Settings or AR-200 Settings screens back to the Choose Settings Screen.

  • Page 38: Changing The Time

    DrillSaw Highspeed 200™ User’s Guide Select the day, month or year, or exit the date settings Adjust settings for day, month or year 2 Changing the Time Select function Time Activate time settings Select time format (am, pm, 24h), select hours,...

  • Page 39: Reset Factory Setting

    DrillSaw Highspeed 200™ User’s Guide Decrease volume Mute 5 Reset Factory Setting Select function Reset Start reset countdown [3] The reset countdown can be interrupted within 5 seconds by pressing the MINUS button 6 Exit setting Select function Exit Confirm with PLUS or MINUS button [3] DFU-0225-2 Rev.

  • Page 40: Factory Settings (P1-P6)

    DrillSaw Highspeed 200™ User’s Guide 7 Factory Settings (P1-P6) Table 20 Factory Settings AR-200C For AR-200M motor with cable Program Speed Torque Coolant supply Coolant Transmissio Motor [rpm] [Ncm ] volume n ratio direction clockwise 15,000 100 % 100 %...

  • Page 41: Ar-200 Settings

    DrillSaw Highspeed 200™ User’s Guide 4.13 AR-200 Settings 4.13.1 Changing the Foot Controller Mode To change from VARIABLE to ON / OFF Switching between variable and ON / OFF is only possible in this menu Select function Foot control Select setting...

  • Page 42: Operation And Frequently Used Functions

    Check the console, the motor and the foot control unit with cables for damage and loose parts before each use. Correct any faults or refer to an authorized Arthrex service partner. Do not operate the AR-200 if it is damaged.

  • Page 43: Changing The Program

    DrillSaw Highspeed 200™ User’s Guide 5.1 Changing the Program Select menu - Program Next program - press PLUS button Previous program - press MINUS button 5.2 Changing the Speed When the safety speed (15,000 rpm for AR-200M / 40,000 rpm for AR-200M-ISO) is reached, an audible signal (safety stop) sounds.

  • Page 44: Changing The Torque

    DrillSaw Highspeed 200™ User’s Guide 5.3 Changing the Torque Settings range from 10 % to 100 %. Keeping PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased. Select menu - Torque Increase torque in 10% steps - press PLUS button Decrease torque in 10% steps –...

  • Page 45: System Shutdown

    DrillSaw Highspeed 200™ User’s Guide Pump ON / OFF Only when the motor is stationary can the pump be switched on or off by operating the GREEN button [13] of the foot control. When the pump is switched off, the pump symbol on the display is crossed out.

  • Page 46: Cleaning And Disinfecting

    To make cleaning and disinfecting easier, always clean and disinfect the Arthrex DrillSaw HighSpeed 200 System immediately after use; do not allow bodily fluids and tissue to dry on any of the system components. Only use disinfectants that have no protein fixing effects.

  • Page 47: Motor With Cable (Ar-200M, Ar-200M-Iso) And Spray Clip (Ar-200Sp)

    DrillSaw Highspeed 200™ User’s Guide Always place the main power switch in the “Off (O), position” and disconnect the power before cleaning the AR-200C console. Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration, exposure times, temperature, and material compatibility.
  • Page 48 DrillSaw Highspeed 200™ User’s Guide Automatic wash cleaning solutions may include, but are not limited to: neodisher® Mediclean forte, Thermosept® alka clean, Prolystica® Ultra Concentrate Enzymatic Cleaner, and ProKlenz NpH Neutral Detegent. CAUTION: Low acid or high alkaline solutions are not recommended, as they...

  • Page 49: Foot Control Unit (S-N1)

    DrillSaw Highspeed 200™ User’s Guide Clean the motor with cable and the motor support before each use. 6.4 Foot Control Unit (S-N1) The foot control is provided non-sterile and must not be sterilized. To clean and disinfect, unplug the cord from the console.

  • Page 50: Sterilization

    DrillSaw Highspeed 200™ User’s Guide 0 Sterilization Sterilization capabilities, cleaning, disinfecting, handling, and storage of instrumentation are the responsibility of qualified facility and/or user personnel. Devices must be properly cleaned and disinfected, prior to sterilization. After sterilization in the autoclave, let the accessory device cool down slowly.
  • Page 51 DrillSaw Highspeed 200™ User’s Guide Steam Sterilization Minimum Parameters: STERILIZATION PARAMETERS: FOR THE USA ONLY: Exposure Exposure Time Drying Time Temperature Gravity 121°C (250°F) 30 Minutes 15 to 30 Minutes Displacement 132°C (270°F) 15 Minutes 15 to 30 Minutes Steam Sterilization 135°C (275°F)

  • Page 52: Irrigation Pump Tubing

    DrillSaw Highspeed 200™ User’s Guide 7.2 Irrigation pump tubing The tubing is supplied pre-packaged sterile, by EO sterilization. Do not resterilize. Sterile devices must be stored in the original unopened packaging, in a cool place, away from moisture and should not be used after the expiration date.

  • Page 53: Maintenance

    DrillSaw Highspeed 200™ User’s Guide 0 Maintenance Regular and proper maintenance of your DrillSaw Highspeed 200 is the best way to protect your investment and avoid non-warranty repairs. Recommended care and handling of the DrillSaw Highspeed 200 includes proper day- to-day operation, cleaning, and sterilization which are extremely important to ensure safe and efficient operation.

  • Page 54: Technical Support

    DrillSaw Highspeed 200™ User’s Guide 9 Technical Support For assistance in using the products identified in this User’s Guide, contact an Arthrex representative or contact the Arthrex Technical Support Hotline at 1-(888) 420-9393, Monday through Friday from 9:00 AM to 5:00 PM EST; or at +49 89 90 90 05 8800 or techsupport@arthrex.de from 8:00 AM to 5:00 PM CET.

  • Page 55: Troubleshooting

    Arthrex service partner. If the problems persist, disinfect the DrillSaw Highspeed 200 and send it to Arthrex using the original packaging. Always send the corresponding console together with the foot control unit and motor. Please enclose a brief explanation of the detected malfunction.

  • Page 56: Troubleshooting Interference With Other Devices

    DrillSaw Highspeed 200™ User’s Guide 10.1 Troubleshooting Interference with Other Devices Try one or more of the following to correct interference: Reorient or relocate the receiving device. • Increase the distance between the devices. • Connect the device to an outlet on a different circuit than the other device(s) •...

  • Page 57: Repair Policy

    DrillSaw Highspeed 200™ User’s Guide 11 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device. DFU-0225-2 Rev. 0 Page 51 of 58...

  • Page 58: Warranty

    12 Warranty This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

  • Page 59: End Of Life, Environmental Directives

    For more information about where you can drop off your medical electronic equipment at the end of its useful life for recycling, please contact Arthrex Customer Service Department.

  • Page 60: Electromagnetic Emissions

    Guidance and Manufacturer's Declaration - Electromagnetic Emissions The DrillSaw Highspeed 200 is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Highspeed 200 should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment –...
  • Page 61 Table 24 Guidance and Manufacturer's Statement - Electromagnetic Immunity The AR-200 DrillSaw Highspeed 200 is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Highspeed 200 should ensure that it is used in such an environment.
  • Page 62 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DrillSaw Highspeed 200 is used exceeds the applicable RF compliance level above, the DrillSaw Highspeed 200 should be observed to verify normal operation.
  • Page 63 DrillSaw Highspeed 200™ User’s Guide DrillSaw Highspeed 200 Table 26 Attachments for AR-200M motor for AR-300SAG Saw attachment sagittal AR-300SR Saw attachment reciprocating AR-300DAO-1 Drill Attachment Style AO AR-300DK30 Drill Keyless Chuck 0-3.0 mm AR-300DK45 Drill Keyless Chuck 2.0-4.5 mm AR-300DJ Drill Jacobs Chuck 0-4.0 mm...
  • Page 64 DrillSaw Highspeed 200™ User’s Guide Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 USA www.arthrex.com Customer Service 1-(800) 934-4404 Toll-Free Technical Support: 1-(888) 420-9393, Monday through Friday, 9:00 AM – 5:00 PM EST. Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany Tel: +49 89 909005-0 www.arthrex.de...

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