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BRASSELER USA BSP MAX II Instructions For Use Manual

Sagittal/oscillator saw
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SURGICAL POWER & ACCESSORIES
Rx Only
PM-X12-700-IR-12.13

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Summary of Contents for BRASSELER USA BSP MAX II

  • Page 1 SURGICAL POWER & ACCESSORIES Rx Only PM-X12-700-IR-12.13...

  • Page 2: Table Of Contents

    Table of Contents Introduction Page 4 Intended Use Page 4 Warnings Page 4 Cautions Page 6 Explanation of Symbols Page 7 Features Page 8 Battery Pack - Installation & Removal Page 9 Saw Blade - Installation & Removal Page 10 Handpiece Operation Page 11 Troubleshooting...

  • Page 3: Introduction

    Introduction Thank you for choosing Brasseler USA® Surgical Power & Accessories as supplier of your large bone power system. The information and procedures described in this manual are intended to assist medical professionals in the safe and effective use, care, cleaning, sterilization and long-term maintenance of BSPMAX™ II Large Bone Power System.
  • Page 4 Warnings (continued) • Clean and sterilize handpiece, battery packs and • DO NOT apply excessive force on a saw blade accessories before every use. when installed in the handpiece, such as bending or prying. Using excessive force may damage the •...

  • Page 5: Cautions

    Cautions • Handpieces are factory sealed. Do not disassemble • Prior to each use, perform the following: or lubricate handpieces, as this may void warranty. - Inspect all devices for proper set up and There are no service requirements expected of the operation.

  • Page 6: Explanation Of Symbols

    Explanation of Symbols Catalog number. Interference. Caution. Manufacturer. Date of manufacture. Serial Number. Do not discard. Dispose of product or recycle in accordance Steam sterilizable. with local laws and regulations. Temperature limit. Do not immerse.

  • Page 7: Features

    Features Blade Lock Button Blade Alignment Tabs Sagittal Head Sagittal Head Release Collar RUN Mode Trigger* SAFE Mode *Shown in RUN position Battery Pack Latch Battery Receptacle Battery Pack • Battery Pack - Rechargeable sterilizable battery pack provides power to the handpiece. •...

  • Page 8: Battery Pack - Installation & Removal

    Battery Pack - Installation & Removal Battery Pack Installation: Battery Pack • Rotate trigger to the SAFE mode. Contacts • Align the battery pack contacts on the top of the Battery Pack Latch battery pack with the battery receptacle on the handpiece.

  • Page 9: Saw Blade - Installation & Removal

    Saw Blade - Installation & Removal Saw Blade Installation Blade Lock Blade Alignment Button Tabs • Rotate trigger to the SAFE mode. • Align the saw blade hub notches with the blade alignment tabs on the sagittal head. • Press the hub of the saw blade down firmly on the blade lock button.

  • Page 10: Handpiece Operation

    Handpiece Operation Sagittal Release • Rotate trigger to the SAFE mode. Collar • Install battery pack and saw blade. • Position the sagittal head at the desired cutting angle by retracting the sagittal release collar and rotating the head. • If using cutting guide, place blade in guide prior to activation and use irrigation.

  • Page 11: Troubleshooting

    Release trigger to reset circuit protection. excessive loading. Handpiece runs after Trigger is malfunctioning. Send handpiece to Brasseler U.S.A. Medical, LLC, for service. trigger is released. Handpiece will not Incorrect blade used. Use only Brasseler USA® saw blades. accept or retain saw blade.
  • Page 12 Troubleshooting (continued) Symptom Potential Cause Solution Saw blade cannot be removed. Blade is worn or damaged. Send handpiece to Brasseler U.S.A. Medical, LLC, for service. Blade lock button not depressed. See saw blade installation and removal. If condition continues, send handpiece to Brasseler U.S.A.

  • Page 13: Care And Maintenance

    Care & Maintenance Brasseler USA® Surgical Power & Accessories • Inspect all devices for proper set up and operation. recommends that all BSPMAX™ II components • Ensure the battery pack installs properly onto the (handpieces, attachments accessories handpiece. excluding battery packs) be returned to Brasseler •...

  • Page 14: Cleaning Recommendations

    Cleaning Recommendations Warnings: Cleaning Procedures: • Clean and sterilize handpieces, battery packs and 1. Remove battery pack and saw blade from the accessories before every use. handpiece. • Prior to cleaning and sterilization, remove saw 2. Scrub debris from the handpiece using a brush blade and battery pack from the handpiece.

  • Page 15: Sterilization Recommendations

    Sterilization Recommendations Steam sterilization has been found both safe and Notes: effective for the sterilization of Brasseler USA® • These processes have been validated as being BSPMAX™ II Large Bone Power System handpieces, capable of cleaning and sterilizing the BSPMAX™ II attachments and battery packs.
  • Page 16 Sterilization Recommendations (continued) Parameters for Sterilizing BSPMAX™ II Sagittal/Oscillator Saw Sterilization Type Minimum Minimum Exposure Dry Time Temperature Time Pre Vacuum (Wrapped) 270° F (132° C) 4 Minutes 15-30 Minutes Pre Vacuum (Wrapped) 273° F (134° C) 3 Minutes 15-30 Minutes Gravity (Wrapped) 250°...

  • Page 17: Specifications

    Specifications 1. Performance With 9.6V Battery Pack With 12V Battery Pack PM-X00-710 PM-X00-715 Speed Range 0-14,000 cpm 0-17,000 cpm Oscillation Arc 5° Duty Cycle 1 minute ON/ 5 minutes OFF, 5 times with a 3 hour rest. Electrical Safety Internally powered equipment. 2.
  • Page 18 Specifications (continued) 4. Electromagnetic Compatibility Requirements Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The BSPMAX™ II handpiece is intended for use in the electromagnetic environment specified below. The user of the BSPMAX™ II handpiece should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 19 Specifications (continued) 4. Electromagnetic Compatibility Requirements continued Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Immunity test IEC 60601 Compliance Electromagnetic environment - guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the BSPMAX™ II handpiece, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 20 Specifications (continued) 4. Electromagnetic Compatibility Requirements continued Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The BSPMAX™ II handpiece is intended for use in the electromagnetic environment specified below. The user of the BSPMAX™ II handpiece should assure that it is used in such an environment. Immunity test IEC 60601 Compliance...
  • Page 21 Specifications (continued) 4. Electromagnetic Compatibility Requirements continued Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Immunity test IEC 60601 Compliance Electromagnetic environment - guidance test level level Voltage dips, short <5%U interruptions and (>95% dip in U voltage variations on For 0.5 cycle power supply input lines 40%U...
  • Page 22 Specifications (continued) 4. Electromagnetic Compatibility Requirements continued Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Recommended separation distances between portable and RF communications equipment and the BSPMAX™ II handpiece. The BSPMAX™ II handpiece is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 23: Repair Service

    Medical, LLC, Service Department can increase the reliability and extend the life of your BSPMAX™ II Large Bone Power System. Brasseler USA® Surgical Power & Accessories warrants any service or repair work performed will be free from defects in material or workmanship for the period of ninety (90) days from date of service or repair. This warranty applies to the actual work performed.

  • Page 24: Warranty

    Brasseler USA® Surgical Power & Accessories.

  • Page 25: Return Goods Policy

    Note: It is unlawful to ship contaminated non-sterilized products. Contact a Customer Service Representative at Brasseler USA® Surgical Power & Accessories at 800-535-6638 to obtain a “Return Merchandise Authorization” (RMA) number. Please include the following information with the returned product(s): •...

  • Page 26: Product Disposal

    STERILIZATION CASE – 3 HANDPIECES PM-X08-000 1/4 IN JACOBS ® CHUCK KEY PM-X08-001 5/32 IN JACOBS ® CHUCK KEY BRASSELER USA® SURGICAL POWER & ACCESSORIES OFFERS A COMPLETE LINE OF CUTTING ACCESSORIES (SAW BLADES/RASPS, BURS, K-WIRES, STEINMANN PINS, TWIST DRILLS AND ORTHAPAEDIC PIN PACKS).
  • Page 30 Zimmer, Inc. Brasseler U.S.A. Medical, LLC, is not affiliated with any of the above and makes no claim to copyrights or trademarks which are the property of these companies. Brasseler USA® and BSPMAX™ are trademarks of Peter Brasseler Holdings, LLC, or its affiliates.

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