Zimmer Universal Power System, Instruction Manual

Page 1: ...Zimmer UNIVERSAL Power System Instruction Manual Battery Electric ...

Page 2: ...LY 13 CLEANING DECONTAMINATION AND STERILIZATION 14 PROCESS FLOW CHART 14 WARNINGS AND PRECAUTIONS 14 PREPARATION FOR CLEANING 15 PRE DISINFECTION 15 PREPARATION OF MANUAL CLEANING MATERIALS 15 MANUAL CLEANING 15 INSPECTION 15 DISINFECTION 15 PREPARATION OF AUTOMATED CLEANING MATERIALS 16 AUTOMATED CLEANING AND DISINFECTION 17 INSPECTION 17 STERILIZATION 17 ELECTROMAGNETIC COMPATIBILITY EMC 18 ELE...

Page 3: ...e triggers which enable the forward and reverse functions All Zimmer UNIVERSAL Power System attachments for drilling sawing and reaming are designed to be connected to Zimmer UNIVERSAL handpieces DESCRIPTION AND TECHNICAL DATA The Zimmer UNIVERSAL Power System handpiece delivers kinetic energy to cutting tools under the form of rotation oscillation or translation BATTERY ELECTRIC HANDPIECE REF 89 ...

Page 4: ...ng operation Ambient temperature 10 C to 38 C 50 F to 100 F Relative humidity 30 to 60 Altitude 2 000 m Not intended for high altitude environments 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 attachments Do not immerse handpiece ELECTRIC PO...

Page 5: ...ll not completely shut off all power from the AC outlet Since the power cord serves as the main disconnect device for the unit you will need to unplug it from the AC outlet to shut down all power Therefore make sure the unit has been installed so that the main power cord does not create a trip hazard and can be easily unplugged from the AC outlet if needed COMPACT BATTERY CHARGER REF 89 8510 421 0...

Page 6: ...tlet if needed BATTERY AND ASEPTIC TRANSFER KIT ATK HOUSING REF 89 8510 440 00 89 8510 440 10 89 8510 440 20 89 8510 440 30 Housing Seal Lid ATK Housing Battery Rechargeable lithium battery Sterilizable housing with detachable funnel for easy aseptic transfer of battery into housing Technical data Rated Voltage 16 5V DC 20A Dimensions Battery 76 mm x 60 mm x 40 mm Housing 88 mm x 66 mm x 62 mm Wei...

Page 7: ...e and transportation or incinerate Exposure to elevated temperature may reduce battery capacity and performance When using heat for sterilization strictly follow the instructions given in the Cleaning Decontamination and Sterilization section CAUTIONS Remove sterilizable battery from handpiece after use Use only FLASH autoclave cycle See Sterilization section Do not exceed 4 minutes at 132 C 270 F...

Page 8: ...ation Instructions TO CONNECT AND DISCONNECT THE ATTACHMENTS Assemble until click is heard Assembled Disconnect pressing both buttons simultaneously TO CONNECT AND DISCONNECT THE BATTERY Assemble until click is heard Assembled Disconnect pressing both buttons simultaneously CAUTION Remove the battery from the handpiece after use Recommended hand position to disconnect the battery and power cord Pu...

Page 9: ...O TURN ON AND OFF THE HANDPIECE UNIVERSAL Double trigger handpiece REF 89 8507 400 00 1 On Position switch to either side 0 Safety position off Position switch in center UNIVERSAL Single trigger handpiece REF 89 8507 400 10 P On Forward Position switch to left Q On Reverse Position switch to right 0 Safety position off Position switch in center ENGLISH ...

Page 10: ...piece REF 89 8507 400 10 P On Forward Position switch to left Q On Reverse Position switch to right Choose the direction of rotation and then press the trigger TO CHARGE THE BATTERIES Connect the Zimmer UNIVERSAL compact battery charger to the mains using cord provided Push power switch button to Ito power on charger Four indicator lights on top of charger will be green when no batteries are conne...

Page 11: ...rger UNIVERSAL battery for Aseptic Transfer Kit REF 89 8510 440 20 Contacts UNIVERSAL sterilizable battery REF 89 8510 440 50 Contacts TO TRANSFER BATTERY INTO STERILE ATK HOUSING CAUTIONS Battery is not sterile STERILE PERSON must not touch battery during transfer Housing is sterile NON STERILE PERSON must not touch housing during transfer Seal between the lid and housing must be present and pres...

Page 12: ...locked Once a click has been heard the battery pack is ready to use TO REMOVE BATTERY FROM ATK HOUSING After the procedure is completed the NON STERILE PERSON B disassembles the Aseptic Transfer Kit ATK by removing the battery from the 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 batter...

Page 13: ...the power is on To ensure the sterilizable power cord is connected to the power supply check that the 2 red points are lined up Push power switch button to Oto power off power supply Mains connection Fuses Power switch button Indicator light Connector To disconnect sterilizable power cord to the power supply hold connector while removing cord from the power supply Hold by the connector to take off...

Page 14: ...e following components must not be cleaned in an automated washer or sterilized For these units the exterior may be cleaned with a cloth that has been dampened not dripping with a mild detergent pH value should be less than 9 Zimmer UNIVERSAL electric power supply REF 89 8510 420 10 Zimmer UNIVERSAL battery REF 89 8510 440 20 for Aseptic Transfer Kit ATK Zimmer UNIVERSAL compact battery charger RE...

Page 15: ...anufacturer s specification Utilize RO or distilled water hardness lower than 120 mg L of CaCO3 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 ...

Page 16: ...infection After 30 minutes contact time wipe the device contact surfaces joints and mated areas utilizing the cover cloth Recommended pH value detergent disinfectant Non shedding cloth Manual disinfection is complete when the device s surface joints and crevices have been manually wiped 6 Final Rinse Rinse product under room temperature RO or distilled water Room temperature RO or distilled water ...

Page 17: ...l 5 00 minutes Water temperature 93 C 200 F Drying 35 00 minutes 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 If necessa...

Page 18: ...nterfere with this product The separation distances recommended in the section Electromagnetic compatibility of this document must be taken into account This product should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary this product should be observed to verify normal operation in the configuration in which it will be used The use of accessories and...

Page 19: ...5 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Zimmer UNIVERSAL power system or Zimmer UNIVERSAL compact battery charger requires continued operation during power mains interruptions it is recommended that the devices be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC ...

Page 20: ...t battery charger b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m RECOMMENDED SEPARATION DISTANCES The Zimmer UNIVERSAL power system and Zimmer UNIVERSAL compact battery charger are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user can help prevent electromagnetic interference by maint...

Page 21: ...ystem disconnect the battery and reconnect it RETURN AUTHORIZATION AND REPLACEMENT INFORMATION When it is necessary to return the Zimmer UNIVERSAL Power System for inspection preventive maintenance or repair within the U S A call 1 800 830 0970 to receive a Return Goods Authorization RGA number Outside the U S A contact your local Zimmer representative The instrument must be properly packaged when...

Page 22: ...ty does not cover damage caused by misuse abuse accident neglect or any use not prescribed in this manual If the unit becomes defective because of misuse or abnormal conditions of operation repairs will be billed at our current rate ALL OTHER WARRANTIES EXPRESS IMPLIED OR STATUTORY INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE LIMITED IN...

Page 23: ...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 Lot number Serial number Reference number or product number QTY Quantity contained in package Caution Federal law USA restricts this device to sale by or on the order of a physician Can be recycle...

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