Zimmer Universal Power System Instruction Manual
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Zimmer Universal Power System Instruction Manual

Battery / electric
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Zimmer® UNIVERSAL Power System
Instruction Manual
Battery / Electric

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Summary of Contents for Zimmer Universal Power System

  • Page 1 Zimmer® UNIVERSAL Power System Instruction Manual Battery / Electric...

  • Page 2: Table Of Contents

    CONTENTS TABLE OF CONTENTS INTENDED USE DESCRIPTION AND TECHNICAL DATA BATTERY / ELECTRIC HANDPIECE ELECTRIC POWER SUPPLY COMPACT BATTERY CHARGER BATTERY AND ASEPTIC TRANSFER KIT (ATK) HOUSING STERILIZABLE BATTERY OPERATING PROCEDURE TO CONNECT AND DISCONNECT THE ATTACHMENTS TO CONNECT AND DISCONNECT THE BATTERY TO CONNECT AND DISCONNECT THE POWER CORD TO TURN ON AND OFF THE HANDPIECE TO START THE MOTOR FORWARD AND REVERSE...

  • Page 3: Intended Use

    DESCRIPTION AND TECHNICAL DATA INTENDED USE The Zimmer® UNIVERSAL Power System is a power tool intended to be used for large and small bone surgeries (such as knee, hip, foot, hand, and shoulder). The Zimmer® UNIVERSAL Power System is to be used by surgeons in the operating room environment. The population of patients is determined by the nature of the surgery and it is the responsibility of the surgeon to treat the patients according to the common practice.

  • Page 4: Electric Power Supply

    • Do not immerse handpiece. ELECTRIC POWER SUPPLY 89-8510-420-00 89-8510-420-10 89-8510-420-20 • Electric power supply Compatible with Zimmer® UNIVERSAL Battery / Electric • handpieces Technical data 100-240V~, 50-60Hz, 4.6-1.6A Input Output 15V DC, 300W 321 mm x 206 mm x 67 mm Dimensions 2.76 kg approximately (without cord)

  • Page 5: Compact Battery Charger

    NOTE: There are no special requirements for transport or storage. Transport or store in an environment that limits exposure to dust, moisture and temperature extremes. CAUTIONS: Use only with Zimmer® UNIVERSAL Battery / Electric handpieces and Zimmer® UNIVERSAL sterilizable power cord. • Use exclusively a certified main power cord integrating earth connection.

  • Page 6: Battery And Aseptic Transfer Kit (Atk) Housing

    Do not operate in patient area. Zimmer® UNIVERSAL compact battery charger (REF 89-8510-421-00) does not meet IEC 60601-1 requirements. • Use only with Zimmer® UNIVERSAL sterilizable battery (REF 89-8510-440-50) or Zimmer® UNIVERSAL battery for Aseptic • Transfer Kit (REF 89-8510-440-20).

  • Page 7: Sterilizable Battery

    Use only FLASH autoclave cycle (See Sterilization section). Do not exceed 4 minutes at 132°C (270°F) or 3 minutes at 134°C • (273°F). The Zimmer® UNIVERSAL Sterilizable Battery is the only component of the Zimmer® UNIVERSAL Power System that can be • sterilized using STERRAD® Technology. For details refer to the STERRAD® STERILITY GUIDE.

  • Page 8: Operating Procedure

    OPERATING PROCEDURE OPERATING PROCEDURE CAUTION: Prior to initial usage, the Zimmer® UNIVERSAL Power System must be cleaned and sterilized per the instructions (See Cleaning, Decontamination and Sterilization Instructions). TO CONNECT AND DISCONNECT THE ATTACHMENTS Push Assemble until “click” is heard...

  • Page 9: To Connect And Disconnect The Power Cord

    OPERATING PROCEDURE TO CONNECT AND DISCONNECT THE POWER CORD Assemble until “click” is Disconnect pressing both buttons simultaneously Assembled heard TO TURN ON AND OFF THE HANDPIECE UNIVERSAL Double trigger handpiece (REF 89-8507-400-00) 1: On 0: Safety position - off Position switch Position switch to either side in center UNIVERSAL Single trigger handpiece (REF 89-8507-400-10)

  • Page 10: To Start The Motor Forward And Reverse

    Position switch to left Position switch to right TO CHARGE THE BATTERIES • Connect the Zimmer® UNIVERSAL compact battery Power Switch button charger to the mains using cord provided. • Push power switch button to to power on charger.

  • Page 11: To Transfer Battery Into Sterile Atk Housing

    Battery is charging • Indicator Light GREEN: Battery is charged and ready for use OFF: Contact your Zimmer local representative Indicator Light • Push power switch button to to power off charger. CAUTIONS: Remove batteries from charger when recharged. •...

  • Page 12: To Remove Battery From Atk Housing

    ATK housing. The instructions from the prior section should be followed with the steps in reverse manner, without using the funnel. WARNING: The Zimmer® UNIVERSAL battery (REF 89-8510-440-20) for Aseptic Transfer Kit (ATK) must not be cleaned in an automated washer or sterilized.

  • Page 13: To Connect The Universal Power Supply

    OPERATING PROCEDURE TO CONNECT THE UNIVERSAL POWER SUPPLY • Connect the Zimmer® UNIVERSAL power supply to the mains using Power switch button cord provided. • Push power switch button to to power on power supply. • Indicator light will turn green when the power is on.

  • Page 14: Cleaning, Decontamination And Sterilization

    The Zimmer® UNIVERSAL sterilizable battery (REF 89-8510-440-50) must not be cleaned and disinfected in an automated washer. When using the Zimmer® UNIVERSAL complete Aseptic Transfer Kit (ATK) with battery, the ATK housing (REF 89-8510-440-10) and the funnel for ATK (REF 89-8510-440-30) must be cleaned, disinfected and sterilized.

  • Page 15: Preparation For Cleaning

    Utilize RO or distilled water (hardness lower than 120 mg/L of CaCO Utilize non-abrasive brushes and non-abrasive, non-shedding soft cloth. CAUTION: Zimmer® UNIVERSAL Power System should not be immersed or cleaned in an ultrasonic machine. MANUAL CLEANING Rinse the handpieces, attachements, sterilizable battery and ATK housing with RO or distilled water until all visible body fluids and tissues have been removed.

  • Page 16: Preparation Of Automated Cleaning Materials

    WARNING: Zimmer® UNIVERSAL Power System should not be immersed or submerged in water or cleaner. PREPARATION OF AUTOMATED CLEANING MATERIALS The automated cleaning and disinfection process has been validated according to AAMI TIR Number 30 and ISO 17664 guidelines.

  • Page 17: Automated Cleaning And Disinfection

    Drying Chamber temperature 99°C (210°F) Only washing parameters shown above have been validated for cleaning effectiveness. However, the performance of Zimmer® UNIVERSAL Power System is not affected in case lower temperature and/or shorter dwell time are used. INSPECTION Inspect each part of the devices to make sure all soil is removed.

  • Page 18: Electromagnetic Compatibility (Emc)

    • exceed 4 minutes at 132°C (270°F) or 3 minutes at 134°C (273°F). The Zimmer® UNIVERSAL sterilizable battery is the only component of the Zimmer® UNIVERSAL Power System that can be • sterilized using STERRAD® Technology. For details refer to the STERRAD® STERILITY GUIDE.

  • Page 19: Electromagnetic Immunity

    IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT – GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the Zimmer® UNIVERSAL power system or Zimmer® UNIVERSAL compact battery charger, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 20: Recommended Separation Distances

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Zimmer® UNIVERSAL power system or Zimmer® UNIVERSAL compact battery charger is used exceeds the application RF compliance levels above, the Zimmer® UNIVERSAL power system or Zimmer®...

  • Page 21: Cord (Cable) Length

    Do not attempt to disassemble the equipment. It is a factory sealed unit with no user serviceable parts inside. No • modification of the equipment is allowed. Zimmer is not liable for any device malfunction resulting from repairs or service not performed by a Zimmer authorized • service center.

  • Page 22: Warranty Information (U.s.a. Only)

    (1) year after the date of shipment from the factory. The warranty period for hoses is six (6) months. Zimmer® UNIVERSAL Power System consumables are warranted to be free from defects in material and workmanship upon delivery. During the warranty period, Zimmer Surgical shall repair (or at its sole option replace) the defective product or part without cost to the purchaser.

  • Page 23: Symbology

    SYMBOLOGY SYMBOLOGY Graphic What it means Consult instructions for use and accompanying documents. Caution. Type BF against electric shock applied part according to IEC 60601-1. Do not immerse. Do not discard with household waste. Conform to the European Medical Device Directive 93/42/CEE + 2007/47/CE for class I medical devices Conform to the European Medical Device Directive 93/42/CEE + 2007/47/CE for class IIa medical devices (notified body number).

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