MicroAire 7000 SERIES Instruction Manual

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Instruction Manual

IM-7505, Rev. E

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Page 1 Instruction Manual IM-7505, Rev. E...
Page 2: Table Of Contents
Warranty, Service & Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34-35 Introduction This manual has been written to help describe the procedures required to keep the MicroAire Series 7000 Battery Large Power System with Handpiece Models: REF 7505, REF 7506, and REF 7507 operating properly .
Page 3: Markings
WARNING: Use care to ensure that there is no electromagnetic interference between this device and other devices in use . CAUTION: Short-Time Operation Only. (2 Minutes Maximum ON Time. Allow to cool before Re-Use.) CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner) . WARNING: Prior to use, all system components (handpiece, couplers, and batteries) should be inspected to detect any damage or malfunction . DO NOT use any component if damage is apparent . WARNING: Prior to use, all system component manuals should be reviewed for important warnings and instructions for use .
Page 4: Standards & Environmental Parameters
 Must be collected separately from household waste  European Conformity mark with MicroAire notified body number 0086  CLASSIFIED BY UNDERWRITERS LABORATORIES, INC . WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1, CAN/CSA C22 .2 NO . 601-M90 Control Number: 8R91...
Page 5: Ref 7505 Drill Reamer Handpiece
“F” position . To select the reverse 7505 drill reamer . direction, move the control switch to the “R” 2. Trigger / Safety Lock – The MicroAire REF position . 7505 Drill Reamer handpiece operates 4. Battery Release Button – Depress this button to at variable speeds and is controlled by remove a battery pack from the handpiece .
Page 6 . Rating: 14.4 VDC 225W * Values are typical and may vary. REF 7505 Drill Reamer Handpiece The MicroAire REF 7505 Drill Reamer is a single-trigger, two-speed, multi-purpose (drill, ream, pin drive) handpiece with a selection of quick-connect Drive Couplers. The couplers automatically key to the correct drive speed (250 rpm or 750 rpm). The individual drive couplers are designed to accept standard orthopaedic instrument fittings including Jacobs, Zimmer ®(Also referred to as Hudson® Modified Trinkle), Hudson®, Aesculap®, Synthes®, and Trinkle® . Adjustable wire and pin driver couplers allow for easy insertion of smooth or threaded wires and pins from 1.6 mm –...
Page 7 . If the handpiece still does not meet the above requirements, return the handpiece for service . 6 . Attach a fully charged MicroAire U.L Classified Battery Pack (REF 7505-710, REF 7500- 615, REF 7500-710) or MicroAire DPC Power Pack (REF 7007-000) to handpiece. To attach the battery/power pack to the handpiece, place the battery under the base of the instrument with the longer side facing the rear of the instrument .
Page 8 8 . If using the REF 7025 Direct Power Console with the REF 7007-000 DPC Power Pack, make sure the REF 7025 Direct Power Console is properly connected and in the “ON” position . Please refer to the instructions for use included with the REF 7025 Direct Power Console for more information .
Page 9: Ref 7506 Oscillating Saw
12. REF 7506 Oscillating Saw Handpiece Features and Descriptions 1. Oscillating Saw Blade Mount – The proprietary 4. Oscillating Saw Speed Switch – The MicroAire REF oscillating saw blade mount securely locks 7506 Oscillating Saw has been designed with a two-...
Page 10 * Values are typical and may vary REF 7506 Oscillating Saw Handpiece The MicroAire REF 7506 Oscillating Saw is a single-trigger, variable speed, multi-purpose handpiece designed for total joint arthroplasty . The saws heavy-duty high speed oscillating mechanism is designed to drive the extra long and wide saw blades required for today’s total knee osteotomies .
Page 11 3 . Check all surgical accessories . Make sure that saw blades are not dull or bent, and that they lock correctly into the handpiece . 4 . To load a saw blade, use ONLY MicroAire “ZO” series large oscillating saw blades . Release the Load/Unload Latch by pulling down and away from the cutting head .
Page 12 8 . If using the REF 7025 Direct Power Console with the REF 7007-000 DPC Power Pack, make sure the REF 7025 Direct Power Console is properly connected and in the “ON” position . Please refer to the instructions for use included with the REF 7025 Direct Power Console for more information .
Page 13: Ref 7507 Reciprocating Saw
12. REF 7507 Reciprocating Saw Handpiece Features and Descriptions 1. Blade Mount – Grippers that hold and align 3. Trigger/Safety Lock – The MicroAire REF reciprocating saw blades in the reciprocating 7507 Reciprocating Saw handpiece operates at saw . The blade mount with blade may be variable speeds and is controlled by depressing oriented in any 360°...
Page 14 * Values are typical and may vary. REF 7507 Reciprocating Saw Handpiece The MicroAire REF 7507 Reciprocating Saw handpiece is a single-trigger, variable speed, multi-purpose handpiece designed for linear bone cutting in total joint arthroplasy and other large bone orthopaedic procedures .
Page 15 3 . Check all surgical accessories . Make sure that saw blades are not dull or bent, and that they lock correctly into the handpiece . 4 . To load a saw blade, use MicroAire “ZR” series large reciprocating saw blades . Rotate the locking collar in the counterclockwise direction to open the blade mount . Insert the saw blade in-between the blade mount grippers and push the blade back into the saw hub until it stops and is fully seated .
Page 16 WARNING: Excessive heat is the most likely cause of patient injury . Any power instrument is subject to overheating, especially in the nose section . Even normal operation of the system in a cycle other than 2 minutes “ON” and allowing the handpiece to cool to room temperature may cause the handpiece to become hot . To check for overheating, test run the handpiece for approximately 30 seconds .
Page 17: Battery Instructions
. The aseptic battery system has been designed for use with all MicroAire battery operated instruments and uses smaller battery cells than the conventional REF 7505-710 Large Power Battery Pack . The aseptic battery provides comparable power, but will have reduced run times. See separate instructions provided with the REF 7500-6XX Aseptic Battery System.
Page 18: Ref 7025 Direct Power Console & Ref 7007-000 Power Pack
REF 7025 Direct Power Console (DPC) The REF 7025 Direct Power Console is designed for use only with MicroAire battery powered instrumentation . The DPC uses the MicroAire REF 7007-000 connecting cable-receptacle only . All personnel should become familiar with the power equipment before it is set-up for use in any surgical procedure .
Page 19: Drive Couplers
Drive Couplers (For use with REF 7505 Drill Reamer Handpiece) The MicroAire Series 7000 REF 7505 Drill Reamer handpiece operates using a selection of quick-connect drive couplers. The couplers automatically key to the correct drive speed (250 rpm or 750 rpm). The individual drive couplers are designed to accept standard orthopaedic instrument fittings including Jacobs, Zimmer ®(Also referred to as Hudson® Modified Trinkle), Hudson®, Aesculap®, Synthes®, and Trinkle®. Adjustable wire and pin driver couplers allow for easy insertion of smooth or threaded wires and pins from 1.6 mm – 4.0mm (.062” – 5/32”) . How to connect drive couplers and wire/pin drivers Attach a large power Drive Coupler (REF 7100/7505-XXX series) to the front of the drill reamer handpiece. To...
Page 20 5 . Being careful of sharp drill flutes, pull on the drill bit to make sure it does not disengage. REF 7100-004 ¼” Keyless Drill Coupler (6.35 mm) – 750 rpm (nominal) This keyless drill coupler accept MicroAire 8051 and 8054 series Jacobs® style twist drills with diameters between 1.0 mm (0.39”) and 6.5mm (.25”) and smooth shank reamers. Due to loosening potential, applications requiring high torque are not recommended while running in reverse with the keyless drive couplers .
Page 21 REF 7100-005 1/8” Keyless Drill Coupler (3.2mm) – 750 rpm (nominal) This keyless drill coupler accept MicroAire 8051 and 8054 series Jacobs® style twist drills with diameters between 1.0 mm (0.39”) and 3.2 mm (1/8”) and smooth shank reamers. Due to loosening potential, applications requiring high torque are not recommended while running in reverse with the keyless drive couplers .
Page 22 REF 7100-051 Zimmer® Drill Coupler – 750 rpm (nominal) (Commonly referred to as Hudson® Modified Trinkle by other manufacturers) The REF 7100-051 Zimmer® Drill coupler is designed to accept standard Zimmer® (Hudson® modified Trinkle) quick-connect drill/reamer attachments . The 750 rpm high speed drive coupler does not provide the high torque often required for reaming in total hip arthroplasty and is more appropriate for low torque reaming/drilling. (Total knee arthroplasty) To insert a reamer or quick-connect adapter into the REF 7100-051 Zimmer® Drill Coupler: 1 .
Page 23 Reaming Drive Couplers (250 rpm) Red ID Band REF 7100-001 Zimmer® Reamer Coupler – 250 rpm (nominal) (Often referred to as Hudson® Modified Trinkle) The REF 7100-001 Zimmer® Reamer Coupler (Hudson® Modified Trinkle) is designed to accept standard Zimmer® style quick-connect reamer attachments . The 250 rpm drive coupler has been designed to provide the high torque required for reaming in total hip arthroplasty . To insert a reamer into the REF 7100-001 Zimmer®...
Page 24 REF 7100-010 ¼” Jacobs® Reamer Coupler (6.35 mm) – 250 rpm (nominal) The REF 7100-010 ¼” Jacobs® Reamer Coupler is designed to accept smooth shank reamers and adapters that do not contain a quick-connect fitting. The couplers 250 rpm drive speed provides for maximum reaming torque. To insert a reamer or twist drill into the REF 7100-010 ¼” Jacobs® reamer coupler: 1 .
Page 25 REF 7100-111 Synthes® Reaming Coupler – 250 rpm (nominal) The REF 7100-111 Synthes® Reamer Coupler is designed to accept standard Synthes® style quick-connect reamer attachments and flexible intermedullary reamers. The 250 rpm drive coupler has been designed to provide the high torque required for reaming . To insert a reamer into the REF 7100-111 Synthes® Reamer Coupler: 1 . Make sure the handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece .
Page 26 Wire and Pin Driving Couplers – (750 rpm) REF 7505-045 Wire/Pin Driver Coupler REF 7505-045M Wire/Pin Driver Coupler Accepts wire/pins from 1.6 mm – 2.8mm (.063” – .11”) Accepts wire/pins from .7 mm – 1.6mm (.028” – .063”) REF 7505-050 Pin Driver Coupler Accepts pins from 3.2 mm – 4.0mm (.126” – .157”) To insert a wire or pin into the wire and pin driver couplers: 1 . Make sure handpiece trigger is set to the “OFF” position and the coupler is properly locked into the handpiece .
Page 27: Drive Couplers
Pulse Lavage Coupler REF 7100-474 Pulse Lavage Coupler This coupler is designed to adapt the REF 7505/7500 Drill Reamer handpiece to the MicroAire Pulse Lavage irrigation tubing sets . To attach Pulse Lavage tubing to the REF 7100-474 Pulse Lavage Coupler: 1 .
Page 28: Cleaning And Sterilization Instructions
Proper cleaning and inspection prior to sterilization will avoid delays during the surgical procedure . Limitations On Reprocessing: Repeated processing, according to the instructions below, has minimal effect on MicroAire reusable surgical instruments . End of life is normally determined by wear and damage due to use .
Page 29 Cleaning: Automated 1) Load the medical devices into the Washer Disinfector . a) Avoid contact between devices (movement during washing could cause damage and washing action could be obstructed) . DO NOT overload the trays . b) Arrange medical devices so that cannulations are not horizontal and battery openings are oriented downwards (to assist drainage). 2) The minimum recommended Washer/Disinfector cycle is below: Title Detergent Minutes...
Page 30 3 . Check the action of moving parts to ensure smooth operation throughout the intended range of motion . 4 . Where instruments form part of a larger assembly, check that the devices assemble with mating components Note: If concerns are noted that may compromise the function of the device, please contact your MicroAire representative .
Page 31 · Do not use instruments when they are still warm . They need to cool down to room temperature · Do not soak instruments to cool them down or wrap cold towels around them . 2 . Flash Sterilization MicroAire Surgical Instruments does not recommend “flash” sterilization for powered surgical instruments. The series 7000 has not been validated for flash sterilization. Please contact MicroAire for the most up-to-date information on this sterilization method .
Page 32: Troubleshooting
Rotate trigger to the upright “ON” position . Instrument is too hot or too cold Allow to return to room temperature Mechanical malfunction Return to MicroAire for service Electrical/magnetic interference Turn off all electrical equipment not present in use Release trigger for one second,...
Page 33: Warranty, Service & Repair
We may be able to help solve the problem quickly without returning the instrument for service . DO NOT disassemble or attempt to service the equipment . It can only be serviced by MicroAire or an Authorized MicroAire Repair Facility . Unauthorized service will void the warranty .
Page 34 This warranty is void in the event of abuse, misuse, or use in other than normal surgical environment, or in the event disassembly, alteration, or repair of the product not authorized by MicroAire, or in the event that the product has not been used in a reasonable manner and in compliance with the written instructions furnished by MicroAire .
Page 35 Extended Warranty/Service Agreement Extended warranties and services agreements are available on MicroAire power equipment . Extended warranties may be purchased while the equipment is covered by the original first year of warranty. If the equipment is out of warranty, it must first be restored, if necessary, to full serviceable condition before being eligible for a service agreement . Table 1 - Guidance and Manufacturer’s declaration - Electronics Emissions - for all ME Equipment and ME Systems Guidance and manufacturer’s declaration – electromagnetic emissions The Drill Reamer Handpiece, Oscillating Saw Handpiece and Reciprocating Saw Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the battery system should assure...
Page 36 Table 2 - Guidance and Manufacturer’s declaration - Electonics Immunity - for all ME Equipment and ME Systems Guidance and manufacturer’s declaration – electromagnetic immunity The Drill Reamer Handpiece, Oscillating Saw Handpiece and Reciprocating Saw Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the battery system should assure that it is used in such an environment .
Page 37 Table 4 - Guidance and Manufacturer’s declaration - Electronics Immunity - for all ME Equipment and ME Systems that are not Life-Supporting Guidance and manufacturer’s declaration – electromagnetic immunity The Drill Reamer Handpiece, Oscillating Saw Handpiece and Reciprocating Saw Handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the battery system should assure that it is used in such an environment .
Page 38 Table 6 - Recommended separation distances between portable and mobile RF communications equipment and the ME Equipment or ME System - for all ME Equipment and ME Systems that are not Life-Supporting Recommended separation distances between portable and mobile RF communications equipment and the SmartDriver battery system (REF 7505, 7506, and 7507.) The Drill Reamer Handpiece, Oscillating Saw Handpiece and Reciprocating Saw Handpiece is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled .
Page 39 NOTES IM-7505, Rev. E...
Page 40 MicroAire Surgical Instruments LLC MediMark 3590 Grand Forks Boulevard Europe 11, rue Emile Zola 0086 Charlottesville, Virginia 22911 U.S.A BP 2332 Phone: (800) 722-0822 (434) 975-8000 F-38033 Grenoble Cedex 2 Order Fax: (800) 648-4309 or (434) 975-4131 France www .microaire .com IM-7505, Rev. E ©2014 MicroAire Surgical Instruments LLC IM-7505, Rev . E, Printed in USA...