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PNEUMATIC SYSTEMS

1. Anspach Pneumatic Systems User s Manual DePuy Synthes 29 Handheld Attachments Assembly Perforator Driver CSR60BM Perforator Driver with Hudson End for Black Max CSR60 Perforator Driver with Hudson End for XMAX system This Perforator Driver attachment allows Hudson style cranial perforators to be used with Black Max and XMAX systems 60 1 Ratio approximately 1 300 rpm Refer to the Cranial Perforator manufacturer s operating instructions for rotational soeed requirements Note Instructions are written such that distal end of handpiece and attachment are pointed away from user CSR60 Disassembly 1 Move handpiece knurled knob to RELEASE position 2 Rotate Perforator Driver to left approximately one quarter turn and remove device 3 Replace red storage cover Black Max Perforator Driver Assembly for handpieces with SECURE and RELEASE 1 Remove red storage cover 2 Lift lever on handpiece 3 Slide Perforator Driver over distal end of handpiece until fully seated Rotate Perforator Driver to right approximately one quarter turn 4 Press down lever on handpiece 5 Pull back retaining sleeve insert Hudson end of cra nial perforator and release retaining sleeve Disassembly 1 Lift lever on handpiece 2 Rotate Perforator Driver to left approximately one quarter turn and remove device 3 Replace red storage cover Perforator Driver Assembly for handpieces with m
2. as indicated on the AutoLube gauge when using these attachments Black Max QD Angle Attachments Refer to Ordering Information section for part numbers 1 Lift Lever on Black Max Align notch on angle attach ment with word RELEASE on the side of the Black Max Next turn angle attachment so notch is aligned with word SECURE which is laser etched on the side of the Black Max 2 Pull down retaining sleeve on angle attachment and rotate to left when attachment is pointed away from you Insert dissection tool Release retaining sleeve by rotating to right Pull dissection tool to ensure proper engagement Return Lever on Black Max handpiece to down posi tion Om a W Note Handpiece is now fully functional Operating pressure is 120 psi 8 3 bar as indicated on the AutoLube gauge when using these attachments B TURQ X B GOLD B GREEN B GREEN R B GREY ADG B TURQ CDA B QD8 Anspach Pneumatic Systems User s Manual DePuy Synthes 17 XMAX STANDARD ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Straight Attachment Assembly Handpiece XMAX system Retaining Sleeve Straight Attachment Dissection Tool ANSPACH Craniotome Attachment Assembly Handpiece XMAX system Retaining Sleeve Dissection Tool Craniotome Attachment ANSPACH Dissection Tool Identification All dissection tools are packaged sterile unless other wise indica
3. MRI Handpiece Speed up to 80 000 rpm Speed 10 000 75 000 rom Handpiece muffler hose 3 81 m 12 50 ft Handpiece and Hose 3 81 m 12 50 ft Outside housing diameter 19 05 mm 0 75 in Outside Housing diameter 17 53 mm 0 69 in Length of housing 91 44 mm 3 60 in Length of Housing 101 60 mm 4 00 in Handpiece weight 70 0 g 2 6 02 Patent Information For patent information go to XMAX system Specifications www DePuy com patentmarking Speed up to 80 000 rom Handpiece muffler hose 3 81 m 12 50 ft Additional Information Outside housing diameter 17 53 mm 0 69 in All specifications are subject to change Length of housing 102 36 mm 4 03 in Handpiece weight 152002 7 02 This device complies with applicable EEC directives C The DePuy Synthes Power Tools Black Max Instrument System is not sponsored by endorsed by or otherwise associated with United States Manufacturing Corp or its Blackmax prosthetic limbs Anspach Pneumatic Systems User s Manual DePuy Synthes 5 GLOSSARY OF SYMBOLS 30 Sec ON 30 Sec OFF x gt A 3MM gt 4Amu gt 5um gt 6mm gt CUTTER RUN ADJUST TUBE SECURE RELEASE lt lt a i Duty Cycle of the DRIVER Company Logo Direction of rotation Direction of rotation for lock position Indicates setting position or location Indicates setting position or location Indicates the drill tip exposure Indicates the attachment s
4. Please refer to cleaning instructions provided with the MA attachments 34 DePuy Synthes Anspach Pneumatic Systems User s Manual FOOT CONTROLS AutoLube Foot Control Caution Do not immerse or sterilize Do not allow liquid to enter AutoLube except as specified in the operating manual for adding Anspach oil 1 Clean Clean AutoLube foot control by wiping with nonabrasive cloth and disinfectant or mild detergent and water after each case 2 Add oil Check oil level and add Anspach oil and filter when level is below MIN OIL level line 3 Store Store in upright position iMRI Foot control Caution DO NOT IMMERSE OR STERILIZE 1 Clean Clean iMRI Foot Control by wiping with non abrasive cloth and disinfectant or mild detergent and deionized distilled or purified water after each case 2 Dry Dry thoroughly with non abrasive cloth Anspach Pneumatic Systems User s Manual DePuy Synthes 30 MANUAL PRECLEANING BEFORE MECHANICAL AUTOMATED CLEANING HIGH SPEED HANDPIECES Detergents e A neutral pH enzymatic detergent is recommended e Alkaline detergents with a maximum pH of 11 may be used but user must demonstrate their effectiveness e The process detergent and any additives must be discussed with detergent manufacturer Caution Do not use any alkaline detergent with a pH greater than 11 Alkaline detergents attack grease and seals which can increase wear and ca
5. Type of Attachment Names of Attachments Straight Attachments SHORT MEDIUM LONG MIA16 SHORT HD MEDIUM HD LONG HD B SILVER B TURQUOISE B VIOLET B BLUE S B MRA S B MRA M B MRA L B TURQ L B BLACK B RED Craniotomes B GREEN B GREEN R CRANI A CRANI A R CRANI A 01 CRANI P CRANI L CRANI L R B TURQ X B GOLD Specialty Attachments ADG B GREY ADG B TURQ CDA CDA QD Attachments B QD14 B QD14 S QD8 QD8 S QD11 QD11 S QD14 QD14 S B QD8 B QD8 S B QD11 B QD11 S Gently insert and remove Anspach Attachment Cleaning Brush ACB wetted with alkaline cleaner through either openings distal or proximal of the attachment as many times as necessary to remove any foreign debris Figure 4 Caution Do not insert anything into the attachment except the ACB as specified Do not force the brush into or through the attachment ACB is to be utilized once per system set and discarded once the system cleaning is complete 4 Rinse Rinse the attachment in a suitable container filled with deionized distilled or purified water and agitate for 15 seconds 9 Inspect Repeat Steps 2 4 until there is no evidence of soils or residuals on the attachment surface or ACB Figure 4 Cleaning Instructions for Minimal Access MA Attachments Minimal Access Drivers MA D20 MA 20BM MA DRIVER Minimal Access Bearing Sleeves MA 10S MA 10C MA 155 MA 15C MA 15ST and MA 19ST Note
6. XMAX system Driver Installation 1 Ensure handpiece is in RUN m 2 Insert driveshaft of driver into distal end of handpiece push and rotate to right until it stops Listen for a click as handpiece knurled knob moves up to seat next to driver 3 Gently twist back and forth to ensure driver is locked into position 24 DePuy Synthes Anspach Pneumatic Systems User s Manual Bearing Sleeve and Dissection Tool Assembly BM 20 Angle Driver 20 Angle Driver or Straight Driver MA 10S Bearing Sleeve 10 cm Straight MA 10C Bearing Sleeve 10 cm Curved MA 155 Bearing Sleeve 15 cm Straight MA 15C Bearing Sleeve 15 cm Curved MA 15ST Bearing Sleeve 15 cm Straight Taper MA 19ST Bearing Sleeve 19 cm Straight Taper 1 Rotate knurled knob on driver to line up arrow with TUBE 2 Fully insert desired bearing sleeve into distal end of driver by lining up black line on bearing sleeve with black line on driver 3 Rotate knurled knob to line up arrow with CUTTER Check security of bearing sleeve by pulling distally 4 Insert dissection tool into distal tip of bearing sleeve Rotate dissection tool slowly until it is fully seated Ro tate knurled knob on driver to line arrow with RUN Note Additional force is required to seat dissection tool into curved bearing sleeve 5 Check security of dissection tool by pulling distally on dissection tool head 6 Bearing sleeve and dissection tool are secure
7. and m 1 Remove red storage cover 2 Move handpiece knurled knob to RUN position 3 Slide Perforator Driver over distal end of handpiece Pull Soeed Reducer towards handpiece and rotate to right approximately one quarter turn until fully seated Handpiece knurled knob will move up to seat next to Perforator Driver 4 Pull Perforator Driver retaining sleeve towards hand piece Insert Hudson end of cranial perforator and re lease retaining sleeve Disassembly 1 Pull Perforator Driver retaining sleeve towards hand piece and remove cranial perforator from distal end of Perforator Driver 2 Move handpiece knurled knob to SAFE position 3 Rotate Perforator Driver to left approximately one quarter turn and remove from distal end of hand piece 4 Replace red storage cover Note The red storage cap provided with the Perfora tor Driver is to prevent damage to the shaft The cap is removed for cleaning washing and steriliza tion The cap is used for storage purposes only 30 DePuy Synthes Anspach Pneumatic Systems User s Manual CLEANING INSTRUCTIONS PNEUMATIC HIGH SPEED SYSTEMS The following manual cleaning and mechanical auto mated cleaning with manual Precleaning instructions have been validated by Anspach for preparing a non sterile medical device this instruction is provided in accordance with ISO 17664 2004 and ANSI AAMI ST81 2010 Warning Transmissible spongiform encephalopa
8. pump spray to the distal end of the attachment and one 1 to the proximal end of the attachment MA D20 G1 QD8 G1 QD11 G1 CSR60 G1 e Applying excess amounts of lubricant will cause the lubricant to drip from the attachment Clean off any excess lubricant Option 2 Non Silicone Based Medical Lubricant e Prepare a lubricating solution of instrument milk non silicone based medical lubricant per the manufactur er s directions e Fully immerse attachment in lubricating solution at room temperature in a suitable container and agitate for 15 seconds e Remove attachment and allow it to drain completely until no visible droplets are coming from it Return attachments to basket for further processing Caution Do not rinse out instrument milk Do not apply mineral oil or other lubricants which may Anspach Pneumatic Systems User s Manual DePuy Synthes 47 STERILIZATION HIGH SPEED HANDPIECES AND ATTACHMENTS The following sterilization instruction has been validated by Anspach in accordance with ISO 17665 Before sterilizing Ensure sterilization equipment is in proper working order as specified by manufacturer En sure equipment manufacturer s instructions are properly employed by trained and qualified personnel Ensure ac tual cycle employed has been properly validated for the device s load configuration being processed and appro Figure 1 priate sterilization indicator devices are included for each p
9. 6 DePuy Synthes conranias oF ohmonafohmon PNEUMATIC SYSTEMS High speed performance and power in a variety of applications This publication is not intended for distribution in the USA USER S MANUAL EK ANSPACH TABLE OF CONTENTS INTRODUCTION Anspach Pneumatic Systems 2 Indications 3 Warnings and Cautions 4 Technical Specifications 5 Glossary of Symbols 6 OPERATING INSTRUCTIONS AutoLube Ill Operating Instructions for Black Max and XMAX 8 Black Max Operating Instructions 11 XMAX Operating Instructions 12 IMRI Instrument System 13 ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Black Max Standard Attachments and Dissection Tool Assembly 16 XMAX Standard Attachments and Dissection Tool Assembly 18 Otologic Curved Micro OCM Attachment and Otologic Curved Micro OCM Burr Support Sleeves 23 Minimal Access Attachments and Dissection Tool Assembly 24 microSaws and Small Attachments Assembly 26 Handheld Attachments Assembly 29 CARE AND MAINTENANCE Cleaning Instructions 31 Manual Cleaning 32 Manual Precleaning Before Mechanical Automated Cleaning 36 Mechanical Automated Cleaning Following Manual Precleaning 42 Inspection and Maintenance 44 Lubrication 47 ATTACHMENTS Sterilization 48 Loading Configuration 50 Troubleshooting 51 Ordering Information 52 ANSPACH PNEUMATIC SYSTEMS HIGH SPEED PERFORMANCE AND POWER IN A VARIETY OF APPLICATIONS D
10. Dissection Tool Disassembly 1 Rotate knurled knob on driver to line up arrow with CUTTER Remove dissection tool from distal end of attachment Bearing Sleeve Adjustment 1 Rotate knurled knob on driver to line up arrow with ADJUST 2 Pull bearing sleeve either 3 mm distally or proximally to desired exposure 3 Rotate knurled knob on driver to line up arrow with RUN Bearing Sleeve Disassembly 1 Rotate knurled knob on driver to line up arrow with TUBE Remove bearing sleeve distal end of driver Driver Removal for Black Max 1 Driver removal is reversal of installation instructions Driver Removal for XMAX system 1 Move handpiece knurled knob to SAFE position 2 Rotate attachment to left approximately one quarter turn and remove from distal end of handpiece Anspach Pneumatic Systems User s Manual DePuy Synthes 25 MICROSAWS AND SMALL ATTACHMENTS ASSEMBLY The microSaws were designed for small bone dissection BM DRIVER er The microSaw Drivers provide direct connection to Black Max and XMAX systems The Drivers also enable rapid exchange of saw head styles through a unique quick dis connect system Keyless Driver Installation DRIVER Black Max Keyless Driver Installation BM DRIVER Keyless Driver 1 Ensure locking lever is up BM DRIVER and DRIVER Duty Cycle 2 Align notch on keyless driver with Release arrow on 30 Sec ON 30 Sec OFF for 8 cycles handpiece whil
11. House Lock Run Unlock Load Product warranty is void if seal is damaged or removed Humidity Limits Instrument System Key Black Max XMAX system iMRI Latex free Certification Products not made with natural rubber latex Anspach Pneumatic Systems User s Manual DePuy Synthes 7 AUTOLUBE II OPERATING INSTRUCTIONS FOR BLACK MAX AND XMAX ASSEMBLY PROCEDURES OF AUTOLUBE III AND HANDPIECE AUTOLUBE II Foot Control Red Plug Oil Fill Cap For additional part numbers refer to the Ordering In Recirculating Bowl formation section Pressure Remove the red plug installed for shipping only from oa the recirculating bowl located on the top of the Au toLube III 2 Turn the silver handle located on the back of the Au toLube Ill to the OPEN position 3 While maintaining the handle in the OPEN position insert the muffler end of the pneumatic handpiece Open Position into the cavity located on top of the recirculating 2 i bowl 4 Insert the muffler until the red ring on the muffler cannot be seen ES gt 5 Rotate silver handle to the LOCK position Check iE ry for secure engagement go Mss Handle gt Operating Pressure Anspach pneumatic handpieces run on air or medical grade nitrogen Standard operating pressure is 90 120 psi 6
12. Never reprocess or reuse iMRI dissection tools iMRI dis section tools must be properly disposed of after a single use 14 DePuy Synthes Anspach Pneumatic Systems User s Manual iMRI Operating Instructions Caution Do not run handpiece without dissection tool and attachment installed 1 Foot control must be placed on floor within reach of surgeon Foot control is not subject to sterilization so should never be placed such that sterile field is compromised 2 Place three drops of IMRI OIL into muffler end of iMRI handpiece hose assembly Do not exceed three drops Caution iMRI OIL is for use with iMRI handpiece only Do not use with other Anspach AutoLube systems iMRI OIL used in AutoLube can damage the sight window resulting in oil leakage 3 Connect muffler end of hose to foot control and in spect handpiece to ensure It is IMRI and that inter nal aspect of handpiece is free of damage or debris Caution Do not run handpiece without dissection tool and attachment installed Damage to handpiece may result if handpiece is operated without dissec tion tools and attachment installed 4 Select appropriate attachment Inspect for any signs of corrosion or damage and ensure it is iMRI Attach attachment to handpiece and turn clockwise to lock onto handpiece Verify locking by pulling on attachment 5 Select appropriate dissection tools and following all established sterile techniques remove it from
13. time a bottle of Anspach lubri cating oil is added Insert the filter by taking the tab and sliding the horseshoe shaped portion of the filter into the cav ity in a downward motion The tab will extend out of the cavity Push muffler filter into vented cover with the hole in muffler filter centered over the attachment screw The muffler is oversized and must be compressed to fit Place the vented cover over the filter cavity and secure by turning the grey wingnut in a clockwise direction AutoLube Filter Insert filter with a downward motion 10 DePuy Synthes Anspach Pneumatic Systems User s Manual BLACK MAX OPERATING INSTRUCTIONS The Black Max Handpiece BLACKMAX N Handpiece Fixed Straight BLACKMAX N LP Low Pressure Handpiece Swivel Angle Operation Caution Firm control of the Black Max must be maintained at all times Never force the dissection tool Let the instrument do the cutting Never use the attachments as a retractor to bend or pry Only Anspach Black Max dissection tools should be used with the Black Max Warning Always use continuous irrigation to pre vent heat build up Always wear personal protection equipment Black Max Directional Features The words SECURE and RELEASE engraved on the side of the Black Max handpiece refer to the locking and unlocking the attachment onto the handpiece The Lever locate
14. 2 8 3 bar If more or less power is de sired the psi may be regulated between 40 and 140 psi 2 8 and 9 6 bar Red Ring inserts fully into Recirculating Bowl 1 Connect the air hose from the AutoLube III to the hospital air source nitrogen tank or hospital nitrogen system 2 Adjust the air source until the desired air pressure reg isters on the gauge of the AutoLube lll Pressure will not register on the AutoLube III until the muffler is in serted and the foot pedal is activated 3 The wall nitrogen tank pressure may read as much as 4 40 psi higher than the AutoLube III gauge Locked Position Note Handpiece is fully functional at this time Special Operating Pressures for Attachments B ORANGE 45 run at 40 psi 2 8 bar B ORANGE 90 run at 40 psi 2 8 bar Special Operating Pressures for Dissection Tools SIL DS A run at 70 psi 4 8 bar SHD DS A run at 70 psi 4 8 bar 8 DePuy Synthes Anspach Pneumatic Systems User s Manual Pressure Relief Valve Note Handpiece hose may include a pressure relief valve to remove excess pressure in the case of hose occlusion between the AutoLube and the valve If the pressure relief valve is actuated during use re move the source of the occlusion Do not attempt to disassemble the pressure relief valve AutoLube Lubrication OIL II Instrument Oil with 1 Replacement Filter Note The AutoLube III has been delivered without oil or a filter installed A bo
15. D11 B QD11 S B QD14 B QD14 S Pneumatic Handpieces BLACKMAX N BLACKMAX N LP XMAX Swivel Angle Handpiece Low Pressure Swivel Angle Hand piece XMAX Handpiece Pneumatic Accessories ACB SDCB AL IIl IRR MA7 AUTOLUBE III AUTOLUBE III DISS AL III DISS 20 AUTOLUBE III FG AUTOLUBE III FG7 AUTOLUBE III IRR AUTOLUBE IIIF FMA7 AUTOLUBE III NK AUTOLUBE III 20 AL 111 30 AL III DISS 30 FILTER II OIL HOSE HOSE 5 HOSE 10 HOSE 10 DISS HOSE 15 DISS HOSE 20 DISS HOSE DISS B CASE TRAY MM CTR RACK XM CASE ro SCHRADER F 05 001 078 Attachment Cleaning Brush Small Diameter Cleaning Brush Foot Control for Irrigation System MA7 Adapter Foot Control Foot Control DISS Adapter Foot Control with 20 Hose DISS Adapter Foot Control with Foot Guard Foot Control with Foot Guard MA7 Adapter Foot Control for Irrigation System Foot Control MA7 Adapter AutoLube Foot Control with Nitrogen Keyed Adapter Foot Control with 20 Hose Foot Control with 30 Hose Foot Control with 30 Hose DISS Adapter AutoLube II and III Filters 5 pkg Instrument Oil w 1 Replacement Filter for AutoLube I and IIl 20 Foot Air Extension Hose 5 Foot Air Extension Hose 10 Foot air Extension Hose 10 Foot Air Extension Hose with DISS Adapter 15 Foot Air Extension Hose with DISS Adapter 20 Foot Air Extension Hose with DISS Adapter 10 Inch Air Extension Hose with DISS Adapter Sterilization Case with Tray Cutt
16. D11 S 10 5 cm Quick Disconnect Angle Attachment QD14 14 cm Quick Disconnect Angle Attachment QD14 S 13 5 cm Quick Disconnect Angle Attachment CSR60 Perforator Driver with Hudson End DRIVER Keyless Driver MM SAGITTAL Sagittal Saw O SAW Oscillating microSaw Attachment R SAW Reciprocating microSaw Attachment S SAW Sagittal microSaw Attachment SA JACOBS Small Attachment Jacobs Chuck SA JLATCH Small Attachment J Latch Black Max Attachments B SILVER 6 1 cm Attachment B TURQUOISE 5 9 cm Attachment B VIOLET 8 2 cm Attachment B BLUE S 11 25 cm Attachment B TURQ L 12 6 cm Attachment B GREY MIA16 16 cm MIA B BLACK 19 cm Attachment B RED 26 65 cm Attachment B MRA S 9 4 cm Revision Attachment B MRA M 16 5 cm Revision Attachment B MRA L 22 cm Revision Attachment B ORANGE 45 Contra Angle Attachment Multiple Angle B ORANGE 90 Right Angle Attachment 90 B GREY ADG 8 7 cm Adjustable Drill Guide Attachment B TURQ CDA Controlled Depth Attachment B GOLD Large Craniotome B GOLD R Rotating Large Craniotome B GREEN Standard Craniotome B GREEN R Rotating Green Craniotome B TURQ X Pediatric Craniotome B QD8 8 cm Angle Attachment B QD8 S 7 5 cm Angle Attachment B QD11 11 cm Angle Attachment B QD11 S 10 5 cm Angle Attachment B QD14 14 cm Angle Attachment B QD14 S 13 5 cm Angle Attachment MA D20BM 20 Angle Driver MA 15S Bearing Sleeve 15 cm Straight MA 15C Bearing Sleeve 15 cm Curved MA 10S Bearing Sleeve 10 c
17. ECLEANING HIGH SPEED HANDPIECES AND ATTACHMENTS Detergents e A neutral pH enzymatic detergent is recommended e Alkaline detergents with a maximum pH of 11 may be used but user must demonstrate their effectiveness e The process detergent and any additives must be discussed with detergent manufacturer Caution Do not use any alkaline detergent with a pH greater than 11 Alkaline detergents attack grease and seals which can increase wear and cause device to malfunction Please note use of alkaline detergents can cause color to fade but this does not impair function of device Bearings and seals of all devices are exposed to greater stress during me chanical automated cleaning than manual cleaning If devices are mechanically cleaned they must be sent to a DePuy Synthes Power Tools Service Center at least once a year for maintenance Warning Do not clean the MA 19ST Minimal Access Bearing Sleeve in the EM XM Cleaning and Sterilization Basket Mechanical Automated Cleaning Guidelines DePuy Synthes Power Tools can only be mechanically cleaned under the following conditions e Cannulations must be precleaned with appropriate brushes as described in Precleaning instructions e Devices must not be cleaned using ultrasonic equip ment e Handpieces must not be immersed in cleaning solution but may be sprayed with it e Fully deionized or purified water must be used during final rinse to prevent corrosion and spots e Devices
18. Lube excessive e Inadequate operating pressure e Check pressure on AutoLube Extra long extension hose handpiece noise from air source could reduce operating pressure Check Schrader connection Check for handpiece hose occlusion Muffler not connected properly e Check connection between muffler and AutoLube Muffler must be inserted past red line Return to DePuy Synthes Power Tools for service Return to DePuy Synthes Power Tools for service Check for handpiece occlusion remove the source of the occlusion Return to DePuy Synthes Power Tools for service Handpiece hose damaged Faulty internal component Pressure Relief Valve activated Handpiece stalling e Rotate dissection tool then activate foot pedal Faulty attachment Clean or replace attachment Handpiece lock engaged e Unlock handpiece Faulty internal component Return to DePuy Synthes Power Tools for service Handpiece does not rotate when foot pedal is activated Inadequate lubrication e Add Anspach oil to AutoLube Handpiece out of balance Return to DePuy Synthes Power Tools for service Handpiece vibration or extremely hot Excessive vibration Dissection tool may be bent e Replace with new dissection tool of dissection tool e Dissection tool may not be fully e Reassemble dissection tool and attachment seated e Improper attachment and e Only use correct dissection tool with appropriate dissection tool combination attachment Possible attachm
19. andpiece and check dissection tool by pulling on dissection tool head Latch will be flush with attachment when dissection tool is secure Note Handpiece is now fully functional Disassembly 1 Lift latch on the distal end of the attachment with your thumb Remove dissection tool and release latch 2 Move handpiece knurled knob to SAFE position 3 Rotate attachment clockwise and remove from distal end of handpiece 20 DePuy Synthes Anspach Pneumatic Systems User s Manual Craniotome and Specialty Attachments CRANI P CRANI P 6 5 cm Pediatric Craniotome CRANI A 6 5 cm Adult Craniotome INTA CRANI L 7 5 cm Large Craniotome CRANI A R 6 5 cm Rotating Adult Craniotome ADG 7 2 cm Adjustable Drill Guide CRANI L CDA 6 8 cm Controlled Depth Attachment CRANI A R Assembly for handpieces with m and ml ADG Distal end of handpiece or attachment is pointed away from user AoE 1 Pull handpiece knurled knob towards LOAD m position and insert dissection tool into distal end of handpiece Rotate dissection tool slowly until dissec tion tool is fully seated 2 Release handpiece knurled knob into RUN im posi tion Note Handpiece is now fully functional UJ Pull dissection tool to ensure proper engagement 4 Slide attachment over distal end of handpiece Pull attachment towards handpiece and rotate attach ment to right approximately one quarter turn until fully seated Handpiece knurle
20. ative magnetic resonance imaging is not being used for actual imaging purposes Caution Do not use in intraoperative magnetic reso nance imaging units rated at greater than 1 5 Tesla Remove iMRI System from intraoperative magnetic resonance imaging volume during imaging Failure to do so could result in unacceptable image noise and or distortion Testing of MRI System as established by ASTM F2213 02 Standard Test Method for Measurement of Magneti cally Induced Torque on Passive Implants in Magnetic Resonance Environment and F2052 02 Standard Test Method for Measurement of Magnetically Induced Dis placement Force on Medical Devices in Magnetic Reso nance Environment confirm there is no detectable mag netically induced torque on handpiece at 1 5 Tesla when tested in a 1 5T magnet and only slight deflection force 10 with 18 of force due to gravity when subjected to a high field strength and high field gradient location 1 5 Tesla when tested in a Siemens 1 5T Magnetom Symphony Maestro Class Unit MRI System is designed for surgical procedures typically involving no more than 15 minutes of continuous ac tively drilling operation If a procedure Is expected to last longer you should be aware handpiece speed and temperature may be affected Normal speed of iMRI System will be less than XMAX due to magnetic effects and because iMRI System does not have continuous oiling The lower speed will not ad versely affe
21. burr fracture e Prior to use visually inspect the instrument s Do not use the instrument s if damaged e To avoid overheating this device employ a duty cycle of 10 seconds ON and 10 seconds OFF for an unlimited number of cycles Note When following these instructions hold hand piece and attachments with distal end pointing away from user OCM Installation for XMAX and EMAX Handpieces 1 Ensure handpiece is in RUN or SECURE position 2 Insert OCM Attachment s drive shaft into distal end of handpiece push and rotate to right until it stops Listen for a click as handpiece knurled knob moves up to seat next to OCM Attachment 3 Gently twist back and forth to ensure OCM Attach ment is locked into position OCM Burr Support Sleeve Assembly 1 Line up arrow located on the distal end of OCM Attachment with flat end of OCM Burr push until fully seated Listen for a click Illustration 1 2 Gently pull OCM Burr to ensure it is locked into posi tion OCM Distal End OCM Burr Support Sleeve Flat End Grooves Illustration 1 Top View Curved Burr Support Sleeve Disassembly 1 Remove OCM Burr from distal end of OCM Attach ment by grasping OCM Burr at grooves Illustration 1 2 Treat the OCM Burr Support Sleeve as biohazardous waste and dispose of accordingly OCM Disassembly for XMAX and EMAX Handpieces 1 Move handpiece knurled knob to SAFE position 2 Rotate OCM Attachment to left a
22. ce merged in fluids e Water in the AutoLube Return to DePuy Synthes Power Tools for service Anspach Pneumatic Systems User s Manual DePuy Synthes 51 ORDERING INFORMATION XMAX Attachments SHORT 5 cm Short Attachment MEDIUM 8 cm Medium Attachment LONG 11 cm Long Attachment LONG S 10 5 cm Long Attachment LONG 01 10 5 cm Long Attachment Non tapered End MIA16 16 cm Minimally Invasive Attachment SHORT HD 5 cm Heavy Duty Short Attachment MEDIUM HD 8 cm Heavy Duty Medium Attachment LONG HD 12 4 cm Heavy Duty Long Attachment XL HD 20 2 cm Heavy Duty Extra Long Attachment ADG 7 2 cm Adjustable Drill Guide CDA 6 8 cm Controlled Depth Attachment CRANI A 6 5 cm Adult Craniotome CRANI A 01 6 5 cm Adult Craniotome Thin CRANI P 6 5 cm Pediatric Craniotome CRANI L 7 5 cm Large Craniotome CRANI A R 6 5 cm Rotating Adult Craniotome CRANI L R 7 5 cm Large Rotating Craniotome MA DRIVER Straight Driver MA D20 20 Angle Driver MA 155 Bearing Sleeve 15 cm Straight MA 15C Bearing Sleeve 15 cm Curved MA 15ST Bearing Sleeve 15 cm Straight Taper MA 19ST Bearing Sleeve 19 cm Straight Taper MA 10S Bearing Sleeve 10 cm Straight MA 10C Bearing Sleeve 10 cm Curved ORANGE 45 45 Contra Angle Attachment ORANGE 90 90 Right Angle Attachment OCM Otologic Curved Micro Attachment QD8 8 cm Quick Disconnect Angle Attachment QD8 S 7 5 cm Quick Disconnect Angle Attachment QD11 11 cm Quick Disconnect Angle Attachment Q
23. ce thoroughly under running cold deionized distilled or purified water for a minimum of two 2 minutes while manipulating the knurled knob Figures 5 and 6 Use a sponge soft lint free cloth or soft bristle brush to remove all visible soil Place locking mechanism in the SAFE position prior to performing the following step Figure 7 Hold the handpiece at a downward angle and insert the Anspach Cleaning Brush ACB wetted with cleaning so lution into the distal end of the handpiece Figure 8 Warning ACB is single use and should only be used to clean one handpiece and associated attachments Caution Do not immerse Do not allow running wa ter to enter distal end of handpiece Do not insert ACB beyond last bristle Do not force ACB into handpiece Do not place the hose end under running water Do not use pipe cleaners i KY ae A y A Biss LN KA Y hk ee Figure 5 Figure 7 Figure 6 Figure 8 Anspach Pneumatic Systems User s Manual DePuy Synthes 37 Manual Precleaning Before Mechanical Automated Cleaning 5 Rinse thoroughly Rinse the handpiece thoroughly under running hot deionized distilled or purified water for a minimum of 2 minutes Figure 9 Place locking mechanism in SAFE position prior to performing the following step Figure 10 O Hold the handpiece at a downward angle and flush in Figures Figure 10 side of the distal end using a sy
24. ct your ability to perform procedure and you will experience little to no magnetic pull on handpiece during use However the following effects may be noted 1 Handpiece speed will slow when handpiece rotating mechanism is held 90 to magnetic field 2 Handpiece temperature will increase when handpiece is held in 90 position for greater than 5 minutes Handpiece should not become uncomfortably warm during normal use procedures lasting greater than 15 minutes could cause handpiece temperature to rise 3 Lock mechanisms of iMRI System and dissection tools are essentially the same as XMAX However to help prevent unintended use of non iMRI devices geome try has been slightly modified to prohibit attachment of non MRI handpiece compatible devices Anspach Pneumatic Systems User s Manual DePuy Synthes 13 IMRI Instrument System Caution Attempts to attach components other than iMRI System accessories to iMRI handpiece could result in significant damage to iMRI Handpiece Straight attachments should be used for no more than 10 procedures Craniotome attachments should be used for no more than five procedures Attachments are not repairable and should be replaced after the recom mended number of uses Metal component parts of IMRI handpiece and attach ments and all iMRI dissection tools are constructed of materials mostly unaffected by magnetic properties of IMRI However these materials have significantly less hardnes
25. d knob moves up to seat next to attachment 5 Attachment and dissection tool are secure Disassembly 1 Move handpiece knurled knob to SAFE position 2 Rotate attachment to left approximately one quarter turn and remove from distal end of handpiece 3 Remove dissection tool from distal end of attachment Anspach Pneumatic Systems User s Manual DePuy Synthes Zi XMAX Standard Attachments and Dissection Tool Assembly QD Angle Attachments QDs QD8 8 cm Quick Disconnect Angle Attachment QD11 11 cm Quick Disconnect Angle Attachment QD14 14 cm Quick Disconnect Angle Attachment QD11 Assembly for handpieces with m and m Distal end of handpiece or attachment is pointed away from user 1 Move handpiece knurled knob to RUN im position 2 Slide attachment over distal end of handpiece Pull attachment towards handpiece and rotate attach ment to right approximately one quarter turn until fully seated Handpiece knurled knob moves up to seat next to attachment 3 Pull retaining sleeve on angle attachment towards handpiece and rotate to left to the RELEASE posi tion 4 Insert dissection tool into angle attachment Rotate dissection tool slowly until it is fully seated Release retaining sleeve on angle attachment by rotating re taining sleeve to right to the SECURE position Note Handpiece is now fully functional 5 Pull dissection tool to ensure proper engagement 6 Attachment a
26. d on the top of the handpiece is used to lock and unlock dissection tools within the handpiece Caution If the dissection tool is not inserted prop erly the Lever will not secure the dissection tool Do not force the Lever For instructions on attachment assembly refer to the specific instructions for each attachment in this manual Attachment Lever Connection Motor Housing Handpiece Black Max Handpiece Lock Cutter A vy a a m gt Cp m A 0 Mm 2 A m Distal End Cutter The location of the lever determines the lock and release of the cutter Anspach Pneumatic Systems User s Manual DePuy Synthes 11 XMAX OPERATING INSTRUCTIONS The XMAX system Handpieces XMAX XMAX Handpiece XMAX H XMAX Handpiece High Strength Hose Operation Caution Firm control of the handpiece must be maintained at all times Never force the dissection tool Let the instrument do the cutting Never use the attachments as a retractor to bend or pry Only Anspach XMAX system dissection tools should be Directional used with the XMAX system Arrows Warning Always use continuous irrigation to Distal End sg prevent heat build up Motor Housing Handpiece Always wear personal protection equipment Knurled Knob Attachment Connection XMAX system Directional Arrows Notice the directional arrows and printing on the distal end of the handpiece housi
27. d soft bristle brush Remove the attachment and dissection tool from the handpiece Figure 1 Note Red storage cap is provided with Perforator Driver to prevent damage to shaft Cap is removed for cleaning washing and sterilization Figure 2 Cap should be used for nonsterile storage purposes only Figure 1 Figure 2 2 Rinse Rinse the attachment under running cold deionized dis tilled or purified water for a minimum of two 2 min utes Use a sponge soft lint free cloth or soft bristle brush to assist In removing gross soil Figures 3 and 4 Caution Do not use high pressure water or air Do not rinse attachment with saline solution Figure 3 Figure 4 Anspach Pneumatic Systems User s Manual DePuy Synthes 39 Manual Precleaning Before Mechanical Automated Cleaning 3 Manipulate moving parts Manipulate all moving parts such as release sleeves un der running cold deionized distilled or purified water to loosen or remove gross soil Figure 5 Fig ure 5 4 Clean Prepare a cleaning solution using neutral pH enzymatic detergent per the manufacturer s directions for correct temperature water quality i e pH hardness and prod uct concentration dilution Fully immerse the attachment in cleaning solution in a Suitable container and manually agitate for 2 minutes Figure 6 Use a sponge soft lint free cloth or soft bris tle brush to remove all visible soil Gent
28. deionized water gt 93 C Dry 40 minutes gt 90 C Caution Do not use neutralizing agent 3 Inspect Visually inspect the devices and repeat the manual pre clean and mechanical automated clean if visible soil re mains Remove seal cap from connector end of handpiece and drain until no visible droplets are coming from the handpiece or connector Anspach Pneumatic Systems User s Manual DePuy Synthes 43 INSPECTION AND MAINTENANCE Perform these activities regularly as per institution policy Warning Do not use any damaged equipment Re turn to DePuy Synthes Power Tools repair facility Attachments Straight Attachments Visually inspect for any damage to the tube B SILVER e LONG e B TURQUOISE LONG S e B VIOLET e LONG O1 s e B BLUE S e LONG HD anor B MRA S e MEDIUM e B MRA M e MEDIUM HD e B MRA L e MIA16 P TURQHE e SHORT B BLACK e SHORT HD e B RED e XL HD Angle Attachments B QD8 QDS Visually inspect for bent or broken drive shaft B QD6 gt QDS and for any damage to the tube B QD11 QD11 B QD11 S e QD11 5 B QD14 e QD14 B QD14 S e QD14 5 QD 8 e MA D20 e MA D20BM e MA DRIVER Craniotomes e B TURQ X e B GOLD e B GREEN Visually inspect for bent or broken foot e B GREEN R e CRANI A e CRANI A R e CRANI L CRANI A e CRANI L R e CRANI P 44 DePuy Synthes Anspach Pneumatic Systems User s Manual Other Attachments Visually inspect for overa
29. e inserting drive shaft of Keyless Driver into handpiece Rotate keyless driver clockwise until The recommendations for times of use for the DRIVER notch is aligned with Secure arrow on handpiece attachments have been determined under average load Push locking lever down to locked position and worst case ambient air temperature of 85 F 29 C Disassembly 1 Raise locking lever 2 Rotate BM DRIVER counterclockwise and remove from handpiece XMAX system Keyless Driver Installation DRIVER Keyless Driver 1 Ensure knurled knob on handpiece is in Run or Secure position 2 Insert drive shaft of keyless driver into handpiece and rotate clockwise until locked Gently twist back and forth to ensure it is locked into position Disassembly 1 Pull knurled knob down and twist counterclockwise until it seats into position 2 Rotate DRIVER counterclockwise and remove 26 DePuy Synthes Anspach Pneumatic Systems User s Manual Oscillating Sagittal and Reciprocating Saw Attachment Assembly S SAW Sagittal microSaw Attachment R SAW Reciprocating microSaw Attachment O SAW Oscillating microSaw Attachment 1 Insert saw attachment drive shaft into distal end of keyless driver Rotate until three tabs on attachment engage three slots in keyless driver 2 Continue to rotate counterclockwise while pushing attachment into keyless driver until attachment locks into position and release ring snaps into position Whe
30. ePuy Synthes Power Tools DePuy Synthes Power Tools manufactures pneumatic and electric high performance instruments and attach ments to meet the specific needs of both surgeon and staff While the advanced design of these instruments provides unparalleled performance and reliability they also allow for effortless assembly for the most demand ing applications No tools are required to assemble dis section tools or attachments All DePuy Synthes Power Tools instruments are manufac tured to conform to rigorous quality standards to pro vide dependable performance Warning Before using any of the Anspach High Speed Pneumatic Systems it is imperative that all individuals working with the system read this oper ating manual The surgeon is responsible for learn ing the proper techniques in the use of this system as improper use may Cause injury If you have any questions after reading this manual please contact your local Sales Representative High Speed Pneumatic Systems The XMAX System sets a new standard for the ulti mate combination of high power smooth operation low noise level and small size This new level of performance provides the perfect pneumatic system to handle a com plete range of surgical procedures ranging from power demanding applications to the most delicate dissection With a speed up to 80 000 rpm at 120 psi 8 3 bar in put pressure the XMAX system is one of the quietest pneumatic handpieces available w
31. eased Anspach Pneumatic Systems User s Manual DePuy Synthes 27 microSaws and Small Attachments Assembly J Latch and Keyless Jacobs Chuck Attachment SA JLATCH Assembly SA JACOBS Jacobs Chuck SA JLATCH J latch Chuck Note Anspach does not supply dissection tools for SA JLATCH or SA JACOBS small attachments Keyless driver refers to either BM DRIVER or DRIVER 1 Insert attachment drive shaft into distal end of keyless sa JacobBS driver Rotate until three tabs on attachment engage three slots in keyless driver 2 Continue to rotate counterclockwise while pushing attachment into keyless driver until attachment locks into position and release ring snaps into position 3 When fully engaged contours on keyless driver body release ring and small attachment will be in align ment Keyless Jacobs Chuck Dissection Tool Removal 1 Press down on center A of release button located J Latch Dissection Tool Assembly on SA JACOBS attachment while rotating knurled 1 Pull back distal sleeve in direction of arrow y on knob on attachment clockwise until fully opened SA JLATCH attachment and hold it down to insert 2 Pull dissection tool out distally for removal dissection tool into distal end of attachment 3 Release button 2 Rotate dissection tool slowly until Tully seated 3 Release distal sleeve and check security of dissection Disassembly tool by pulling distally on dissection tool microSaw and Small Attachment Removal A Dissect
32. ece knurled knob into RUN im position Note Handpiece is now fully functional 5 Pull dissection tool to ensure proper engagement 6 Attachment and dissection tool are secure Disassembly 1 Move handpiece knurled knob to SAFE position 2 Remove dissection tool from distal end of attachment 3 Rotate attachment to left approximately one quarter turn and remove trom distal end of handpiece SHORT F 2 MEDIUM LONG MIA16 SHORT HD e MEDIUM HD LONG HD Anspach Pneumatic Systems User s Manual DePuy Synthes 19 XMAX Standard Attachments and Dissection Tool Assembly Orange 45 or 90 Contra Angle Attachments ORANGE 45 ORANGE 45 45 Contra Angle Attachment ORANGE 90 90 Right Angle Attachment Caution Set AutoLube operating pressure to 40 psi 2 8 bar ORANGE 90 aa jan Assembly for handpieces with m and s 4 1 Ensure knurled knob on handpiece is in RUN i position 2 Slide attachment over distal end of handpiece Push attachment towards handpiece and rotate attach ment counterclockwise until fully seated Handpiece knurled knob moves up to seat next to attachment 3 Push latch on the distal end of the attachment up with your thumb 4 Insert dissection tool into the side of the distal end opposite side of latch while rotating slowly until dissection tool seats 5 Release latch and check security of attachment by pulling it away from h
33. ent bearing damage Return attachment to DePuy Synthes Power Tools for service Black Max Lever will not lower Dissection tool not seated properly Reassemble dissection tool and attachment Debris built up inside handpiece e Remove attachment lift lever and tap distal tip of handpiece against hard surface until debris is dislodged e Broken dissection tool in handpiece Lift lever tap distal tip of handpiece against hard surface until dissection tool is dislodged XMAX knurled e Dissection tool not seated properly Reassemble dissection tool and attachment knob will not e Debris built up inside handpiece e Remove attachment and tap distal tip of handpiece hard secure Surface until debris is dislodged e Broken dissection tool in handpiece Remove attachment and tap handpiece against hard surface until dissection tool is dislodged Attachment is hot Debris lodged inside attachment e Clean attachment using Anspach attachment cleaning instructions located in this manual Return attachment to DePuy Synthes Power Tools for service Possible bearing damage Craniotome Excessive force used in operation e Do not use replace attachment attachment is bent Inoperative Foot Oil leaking out of AutoLube Replace AutoLube filter check oil level Control Do not overfill AutoLube e Faulty air connection e Check connection at air source e AutoLube was sterilized or sub e Return to DePuy Synthes Power Tools tor servi
34. ent or damage to system Instrument operator and all operating room personnel must wear eye protection Visually inspect for damage before using do not use If damage Is evident Do not use if the product sterilization barrier or its pack aging is compromised Do not use or discontinue use of powered equipment exhibiting excessive temperatures that can cause patient injury necrosis and or user discomfort Use of damaged or improperly maintained power equip ment and or misused powered equipment can result in excessive temperatures Use caution to avoid cutting or tearing gloves while handling dissection tools Dissection tools must be adequately retained within attachment to prevent distal migration which may cause Injury Confirm attachment is proper size for dissection tool and that it is secure Gently pull on dissection tool shaft to ensure it is fully seated and properly installed Only cut visible areas unless an image intensifier is uti lized Delicate structures in proximity to dissection must be thoroughly protected to prevent injury Maintain firm control of instrument at all times Do not bend or use as a lever Use a gentle tapping motion or side to side motion and let instrument do cutting Do not use excessive force Forcetul side loading of dissection tool may cause frac ture of dissection tool which may cause injury Dissection tools are disposable and intended for single patient use only Do not res
35. etters and numbers designate the part number the second group of letters and numbers designate the lot number Each attachment Is laser marked with its corresponding part number Black Max Straight Attachments Refer to Ordering Information section for part num bers 1 Lift Lever on handpiece Align notch on attachment with RELEASE on side of Black Max handpiece Turn attachment so notch is aligned with word SECURE 2 Insert dissection tool into attachment Return Lever on Black Max handpiece to down position Pull dissection tool to ensure proper engagement 4 Adjust air source until desired air pressure registers on AutoLube gauge UJ Notes e Air pressure will not register until foot pedal is depressed e Handpiece is now fully functional The operating pressure is 120 psi 8 3 bar as indicated on the AutoLube gauge when using these attachments except for those specified in AutoLube IIl Operating In structions section Black Max Contra and Right Angle Attachments B ORANGE 45 Contra Angle Attachment Multiple Angle B ORANGE 90 Right Angle Attachment 90 1 Lift Lever on handpiece Align notch on attachment with RELEASE on side of Black Max handpiece Turn attachment so notch is aligned with word SECURE 2 Push latch on the distal end of the attachment up with your thumb 3 Insert dissection tool into the side of the distal end opposite side of latch while rotating
36. etting refer to MA D20 and MA DRIVER section in this document for further details Indicates position or location Indicates position or location Indicates action of rotation and position for Secure LOCK and Release UNLOCK Direction of rotation Direction of rotation for lock position RUN SAFE a E D a g r p 0S O a E O arene gt 00 0000 Direction of rotation Located on the Handpiece this indicates position of the knurl knob to the de sired location Symbol with yellow background CAUTION Refer to accompanying documentation Consult Operating Instructions Temperature Limits Reference Number A K A Item Number Catalog Number Part Number Lot A K A Lot Number Batch Number Batch Code Serial Number Single Use Only A K A Do Not Reuse Manufacturer Authorized European Union Represen tative Sterilized Using Irradiation Use By Date A K A Do Not Reuse CAUTION Refer to accompanying documentation 6 DePuy Synthes Anspach Pneumatic Systems User s Manual Sm Aa ert a gRoKen Keep Dry A K A Protect trom Mois ture Sterile unless damaged or open United States Federal law restricts this device to sale by or on the order of a physician or other licensed health care provider CE Mark A K A CE Mark notified body number Conformit Europ enne Meaning Device complies with applica ble EEC Directives Certified Accredited Test
37. f handpiece refer to locking and unlocking attachment on handpiece respectively Lift lever on handpiece 2 Align notch on Sagittal Saw with RELEASE on handpiece 3 Turn Sagittal Saw so notch is aligned with SECURE on handpiece 4 Press down lever on handpiece 5 For B SAGITTAL see Blade Assembly Sagittal Saw Assembly and Disassembly for handpieces with m and wm Distal end of handpiece or attachment is pointed away from user 1 Remove red storage cover Move handpiece knurled knob to RUN position 2 Slide Sagittal Saw over distal end of handpiece Pull Sagittal Saw towards handpiece and rotate to right approximately one quarter turn until fully seated Handpiece knurled knob will move up to seat next to Sagittal Saw 3 Sagittal Saw is secure 4 See Blade Assembly Ei ANSPACH Disassembly 1 Move handpiece knurled knob to SAFE position 2 Rotate Sagittal Saw to left approximately one quarter turn and remove from distal end of handpiece Blade Assembly B SAGITTAL MM SAGITTAL 1 Raise and fully extend extension handle on saw blade attachment mechanism 2 Rotate extension handle counter clockwise to open saw blade mounting plates 3 Insert saw blade into opening and align saw hub with locking pins in mounting plates Blades can be aligned in 45 degree increments 4 Rotate extension handle clockwise to secure saw blade and lower extension handle into closed posi tion
38. ing Burr Rack Sterilization Case with Tray Pistol Grip for Black Max SCHRADER Adapter Female Lubricant for Anspach Systems 110 ml Anspach Pneumatic Systems User s Manual DePuy Synthes 53 EN ANSPACH 6 DePuy Synthes COMPANIES OF Yohmonsfohnron Flo inapired The Anspach Effort Inc 4500 Riverside Drive Palm Beach Gardens FL 33410 USA EC REP Synthes GmbH Eimattstrasse 3 CH 4436 Oberdorf www depuysynthes com This publication is not intended for distribution in the USA 036 001 506 DSEM PWT 1114 0049 2 08 15 All rights reserved DePuy Synthes Power Tools a division of DOI 2015
39. ion tool and attachment are secure 1 With one hand supporting attachment rotate release ring on keyless driver or e12 handpiece with other J Latch Dissection Tool Removal hand counterclockwise until attachment is released 1 Pull back distal sleeve in the direction of arrow v on SA JLATCH and hold it down while pulling dissection tool out distally for removal 2 Release the distal sleeve Keyless Jacobs Chuck Dissection Tool Assembly 1 Press down on center A of release button located on SA JACOBS attachment while rotating knurled knob on attachment clockwise until fully opened 2 Insert dissection tool into distal end of attachment un til it touches bottom 3 Rotate knurled knob counterclockwise while centering cutter on attachment until tight release button 4 Check security of dissection tool by pulling distally on dissection tool 5 Dissection tool and attachment are secure Caution Do not press down on release button while attachment is in use 28 DePuy Synthes Anspach Pneumatic Systems User s Manual HANDHELD Al TACHMENTS ASSEMBLY Sagittal Saws B SAGITTAL Black Max Sagittal Saw MM SAGITTAL Sagittal Saw for XMAX system The B SAGITTAL and MM SAGITTAL operate at 120 psi providing 20 000 cycles per minute while it oscillates through a blade arc of 4 degrees Black Max Sagittal Saw Assembly for handpieces with SECURE and RELEASE 1 The words SECURE and RELEASE engraved on side o
40. ith 35 more power than Black Max and 50 more than microMax Plus The Black Max operating at 80 000 rom at 120 psi 8 3 bar offers smooth controlled bone dissection The iMRI Instrument System provides an Intraoperative MRI compatible configuration The iMRI Instrument System utilizes non magnetic materials in the handpiece attachment and dissection tool components that have been approved tor use with field strengths up to 1 5 Tesla J Y p LA Spine surgery Neurosurgery otology and neurotology 2 DePuy Synthes Anspach Pneumatic Systems User s Manual INDICATIONS XMAX pneumatic system Cutting and shaping bone Black Max Cutting and shaping bone MRI Surgical Drill System The Anspach iMRI Surgical Drill System including pneu matic drill motor foot control nosepiece attachments and cutters is indicated for intraoperative non imaging use within a Magnetic Resonance Imaging MRI environ ment rated at 1 5 Tesla or less for surgical cutting shaping and removal of bone including bones of the skull and spine XMAX system Black Max DANSPACH MRI Anspach Pneumatic Systems User s Manual DePuy Synthes 3 WARNINGS AND CAUTIONS Warnings Irrigation is necessary for proper operation Surgeon is responsible for learning proper techniques in use of equipment improper use may cause serious injury to user or pati
41. its pack aging insert it into and through attachment into handpiece and lock into place Verity locking by pull ing on dissection tools If using craniotome dissection tool should be put into handpiece first then put cra niotome over dissection tools 6 Attach iMRI foot control to air or nitrogen supply Fully depress foot pedal and adjust supply air pressure such that gauge on foot control indicates 120 psi 7 With handpiece in intraoperative magnetic resonance imaging field but away from patient fully depress foot control and assess handpiece for noise vibration wobble and whipping If assembly was without diffi culty and handpiece sounds and feels right initiate or continue with use 8 During procedure continuously assess cutting effec tiveness Though iMRI dissection tools are designed to cut effectively they are constructed of a much softer metal than standard non iMRI Anspach dissection tools which you may be accustomed to Because of material softness IMRI dissection tools will dull more quickly If you notice a reduction in cutting effective ness stop and replace dissection tools Warnings Do not reprocess or use reprocessed dissection tools iMRI dissection tools are constructed of stainless steel that is subject to dulling and possi ble distortion during initial use Reprocessors may not be able to reprocess dissection tools to their original design condition and reuse could result in excessive whip
42. ll damage or e ADG missing components e B GREY ADG e B TURQ CDA e B ORANGE 90 e B ORANGE 45 e BM DRIVER e CSRGOBM e CDA e CSR60 CSR60 e DRIVER e MDA e ORANGE 45 e ORANGE 90 e O SAW e R SAW e S SAW e SA JACOBS e SA JLATCH GREER EDUCER 60 e Visually inspect for damage hose Foot Controls e Visually inspect for damage to the e All Autolube Models housing or pedal Anspach Pneumatic Systems User s Manual DePuy Synthes 45 Inspection and Maintenance Handpiece e XMAX e XMAX H e BLACKMAX N e BLACKMAX N LP e Ensure that the knurl knob operates properly e Visually inspect for damage to the silicone hose e Connect to foot control and operate The handpiece should operate smoothly There is no requirement to operate with attachment or dissection tool 46 DePuy Synthes Anspach Pneumatic Systems User s Manual LUBRICATION HANDPIECES Do not lubricate handpieces ATTACHMENTS Caution This step is for attachments only Do not lubricate handpieces Option 1 05 001 078 Lubricant for Anspach Systems 110 mL e Follow all instructions provided in the accompanying documentation delivered with the article e For the following attachments apply one 1 pump spray to the proximal end of the attachment SHORT G1 MEDIUM HD G1 SHORT HD G1 MEDIUM G1 LONG HD G1 CRANI A G1 LONG G1 CRANI L G1 MIA16 G1 CRANI P G1 e For the following attachments apply one 1
43. ly use ACB or SDCB wetted in cleaning solution to clean cannulations of attachment The brushes may be inserted from the distal or proximal end of the attach ment Figure 7 Warning ACB and SDCB are single use and should only be used to clean one set of attachments Caution Do not force ACB or SDCB into or through attachment Do not use ACB or SDCB to clean the MA D20 MA D20BM and MA DRIVER For Mini mal Access Attachment Bearing Sleeves use SDCB only Do not use pipe cleaners Note DO NOT IMMERSE as marked on the attachment is for Operating Room personnel only The SDCB may be inserted from the distal or proxi mal end of the bearing sleeve Figure 7 40 DePuy Synthes Anspach Pneumatic Systems User s Manual 5 Rinse thoroughly Rinse the attachment thoroughly under running hot de ionized distilled or purified water for a minimum of two 2 minutes Figure 8 Use a syringe or pipette filled with hot deionized distilled or purified water to flush lumens or channels Figure 9 Caution Do not use high pressure water or air Do not rinse attachment with saline solution Figure 8 Figure 9 6 Inspect Visually inspect the attachment and repeat Steps 2 through 6 until no visible soil remains Warning Manual Precleaning must be followed by mechanical automated cleaning Anspach Pneumatic Systems User s Manual DePuy Synthes 41 MECHANICAL AUTOMATED CLEANING FOLLOWING MANUAL PR
44. m Straight MA 10C Bearing Sleeve 10 cm Curved MA 15ST Bearing Sleeve 15 cm Straight Taper MA 19ST Bearing Sleeve 19 cm Straight Taper B SAGITTAL Black Max Sagittal Saw BM DRIVER Keyless Driver O SAW Oscillating microSaw Attachment R SAW Reciprocating microSaw Attachment S SAW Sagittal microSaw Attachment CSR60BM Perforator Driver with Hudson End SA JACOBS Small Attachment Jacobs Chuck SA JLATCH Small Attachment J Latch 52 DePuy Synthes Anspach Pneumatic Systems User s Manual IMRI Instrument System IMRI MOTOR IMRI FOOT CTRL IMRI SHORT IMRI SHORT HD IMRI CRANI A IMRI S 4B IMRI S 1004TD IMRI S 1R IMRI A CRN IMRI SHD 6B IMRI S 8NS M IMRI OIL Irrigation System IRRIGATE TUBE IRRIGATE TUBE HF IMRI Handpiece IMRI Air Control IMRI Short Attachment IMRI Short HD Attachment IMRI Crani A Attachment 4 mm Fluted Ball 1 mm x 4 mm Twist Drill w Stop 1 4 mm x 12 8 mm Fluted Router 1 85 mm x 16 mm Fluted Router 6 mm Fluted Ball 3 mm Fluted Matchstick extends 8 9 mm less IMRI Synthetic Oil Sterile Tubing and Hoseclips High Flow Sterile Tubing and Hoseclips IRR CLIP 10 Irrigation Clip for SHORT IRR CLIP 20 Irrigation Clip for QD8 QD8 S B QD8 IRR CLIP 30 Irrigation Clip for SHORT HD B SILVER IRR CLIP 40 Irrigation Clip tor MEDIUM HD LONG HD B BLUE S B VIOLET IRR CLIP 50 Irrigation Clip for MEDIUM LONG LONG S B TURQ L IRR CLIP 60 Irrigation Clip for QD11 QD11 S QD14 QD14 S B Q
45. mn TECI an nart le PTA i ACLL CLOE naaa Uat ae inn AAA A na y Dr DN e A E a es es ee ee Pine wl ISS a pa e a a tt dd A 1 Piet a ane eT MAMA a E MEDIUM HD ARRRRRAN ne a jah mi mm l mmm Jee eee PT de MFTO LLL PTS r i tee 1 TI ML manana it TERHET a i Y dad SHORT HD Dn AT AARNA e o A 0 maha re ELCO TLL Vitra TuC Pees 20 1008 00 100 dt tPF O O Sui 1313 Hietler ieis tl Ele Pote be jols pjs je J te 1 909 Bete l lt ele a f 6 Lew ine Sl s m aai mi AE A ee Halisi A A NAAA im AS AA TT ELC _ MA aaa HA dada ATINA e e tied _ see eee rere ASSP SSS AI AA mt i es ee lo Yor par br ft Ye be uUusy we y 2 0 10 10 10 10 10 SS E 1 TELELILLILIL Leo a wees IMM cia ley Y E gt ESEE eeen ee REN RE EEI ERTE EE T a ee es ee ALA A A ee ee ee A slololeleblel eel eeey della da tatni I IWR ER ER TR They APPO _ At PRA OF OR Oe RERARAY A t o bdo biin aii ds Y amp dls m sd a MA Bearing Sleeves excluding MA D20 QD8 amp QD11 CRANI P CRANI A CRANI L MA19 ST 50 DePuy Synthes Anspach Pneumatic Systems User s Manual TROUBLESHOOTING PNEUMATIC HANDPIECES BLACK MAX AND XMAX Problem Possible Cause Solution Lack of power or e Inadequate lubrication e Add OILII to Auto
46. must be cleaned immediately after use to en sure blood and tissue never dry on them e National regulations must be observed e You must follow standard hospital procedures e You must follow manufacturer s recommendations for any detergents disinfectants and washing equipment used 42 DePuy Synthes Anspach Pneumatic Systems User s Manual 1 Loading the Basket Load the devices in the basket by securing them in the appropriate brackets as marked on the basket Figure 1 Reference loading configuration pictures on page 49 for proper placement and positioning of devices Where applicable distal end of devices should be angled down ward Warning Red protective cap for Perforator Driver must be left off during mechanical automated clean ing Figure 2 Caution Connector ends of electric and pneumatic handpieces must be sealed with special seal caps provided Figure 3 Note Before putting on seal cap turn black cap to wrap cable tight around it Figure 4 Figure 2 Figure 3 Figure 4 2 Mechanical Automated Cleaning Cycle Process Parameters Duration Cleaning Cycle minimum Instructions Rinse 2 minutes Cold deionized or purified water Prewash 1 minutes Warm deionized or purified water gt 40 C use detergent Cleaning 2 minutes Warm deionized or purified water gt 45 C use detergent Rinse 5 minutes Rinse with deionized or purified water Thermal Processing 5 minutes Hot
47. n and any additional PPE required Caution Do not use alkaline detergent with a pH greater than 11 Alkaline detergents attack grease and seals which can increase wear and cause device malfunction Please note use of alkaline detergents can cause color to fade but this does not impair function of device Do not use ultrasonic equipment or corrosive or harsh chemical soaps Do not rinse attachment with saline solution Note DO NOT IMMERSE as marked on attach ments is for OR personnel only 1 Preparation Gather all necessary supplies including Attachment Cleaning Brush ACB sponge lint free cloth and soft bristle brush Remove the attachment and dissection tool trom the handpiece Figure 1 CSR60 and CSR60 BM only The red storage cap pro vided with the Perforator Driver is to prevent damage to the shaft The cap is removed for cleaning washing and steriliza tion Figure 2 The cap is used for storage purposes only 2 Immerse Fully immerse the attachment in an alkaline cleaner with a maximum pH of 11 non chlorinated detergent pre pared as described on the product label at room tem perature In a suitable container and agitate for 15 sec onds Figure 3 Figure 1 Figure 2 Anspach Pneumatic Systems User s Manual DePuy Synthes 33 Manual Cleaning 3 Clean cannulations Caution This step refers ONLY to the following at tachments for other attachments proceed to step 4
48. n fully engaged contours on keyless driver body release ring and saw attachment will be in alignment Sagittal Saw Blade Assembly 1 Press down on release button to open saw blade mounting plate 2 Insert saw blade into opening through slot on mount ing plate and align saw blade hub with locking pins in mounting plate 3 Release button and ensure mounting plate is firmly seated on saw blade without gaps Reciprocating Saw Blade Installation 1 Rotate chuck counterclockwise until chuck has opened sufficiently to accept a saw blade 2 If blade has a shank with a shaft insert shaft of blade in chuck jaws until it is fully inserted and tighten chuck knob clockwise until snug 3 If blade has a flat shank insert blade into slots in chuck until it is fully inserted and tighten chuck knob clockwise until snug Oscillating Saw Blade Assembly 1 Press down on release button to open saw blade mounting plates 2 Insert saw blade into opening and align saw blade hub with locking pins in mounting plates Oscillating saw blades can be aligned in 45 increments 3 Release button and ensure mounting plates are firmly seated on saw blade without gaps S SAW R SAW O SAW Saw Blade Removal 1 Saw blade removal is reverse of installation Disassembly Saw and Small Attachment Removal 1 With one hand supporting attachment rotate release ring on keyless driver with other hand counterclock wise until attachment is rel
49. nd dissection tool are secure Disassembly 1 Pull retaining sleeve on angle attachment towards handpiece and rotate to left 2 Remove dissection tool from distal end of attachment 3 Move handpiece knurled knob to SAFE position 4 Rotate attachment to left approximately one quarter turn and remove from distal end of handpiece 22 DePuy Synthes Anspach Pneumatic Systems User s Manual OTOLOGIC CURVED MICRO OCM ATTACHMENT AND OTOLOGIC CURVED MICRO OCM BURR SUPPORT SLEEVES Device Description The Otologic Curved Micro OCM Attachment connects to XMAX Pneumatic and EMAX 2 and EMAX 2 Plus Electric Systems and accepts OCM Burr Support Sleeves which are available in various cutting burr styles The OCM Burr Support Sleeve OCM Burr consists of the cutter and an outer sleeve that protects and supports the rotating shaft of the cutting burr OCM Burr Support Sleeve lt Ho y 1 me End tes AS Drive Shaft Flat End Side View Indications for Use When used with the ANSPACH Systems the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology proce dures such as cochleostomies Warnings e Prior to first use the OCM Attachment must be processed as per the included Cleaning and Steril ization instructions e It is not intended for gross bone removal Heavy loading and or lack of irrigation while performing bone dissection may result in
50. ng RUN mm LOAD m and SAFE These terms refer to locking and unlocking the attachment and dissection tool onto the handpiece Figure 1 Figure 1 For instructions on attachment assembly refer to the specific instructions for each attachment in this manual 12 DePuy Synthes Anspach Pneumatic Systems User s Manual IMRI INSTRUMENT SYSTEM MRI Instrument System IMRI MOTOR IMRI Motor IMRI FOOT CTRL IMRI Air Control IMRI SHORT MRI Short Attachment IMRI SHORT HD MRI Short HD Attachment IMRI CRANI A IMRI Crani A Attachment IMRI OIL IMRI Synthetic Oil For additional components refer to page 52 Use Care and Operating Instructions Warning Do not use any attachments or dissection tools with iMRI handpiece not manufactured by An spach or not identified as iMRI Do not operate handpiece without attachment and dissection tool installed Read and understand thoroughly before operating your new iMRI Instrument System Failure to do so could lead to injury to you or your patient or cause severe damage to this equipment The iMRI Instrument System is a design modification of the Anspach microMax System Refer to the XMAX Operating Instructions section for additional assembly instructions iMRI System and dissection tools are constructed of ma terials that permit intraoperative use in an intraoperative magnetic resonance imaging unit rated at 1 5 Tesla or less and only when intraoper
51. ng cleaners disinfecting agents containing chlorinated phenols will result in premature hose failure Do not use hy pochlorite i e bleach solutions since these will corrode metal components Do not use alkaline de tergent with a pH greater than 11 Alkaline deter gents attack grease and seals which can increase wear and cause device malfunction Please note use of alkaline detergents can cause color to fade but this does not impair function of device 1 Preparation Gather all necessary supplies such as a lint free cloth Remove the attachment and dissection tool from the handpiece Figure 1 2 Clean Wipe with a clean deionized distilled or purified water dampened cloth and mild detergent neutral pH Caution DO NOT IMMERSE Handpiece must not be exposed to ingress of water or to severe physical trauma degradation of unit function and or perfor mance may occur 3 Inspect Visually inspect the handpiece and repeat step 2 until no visible soil remains Figure 1 32 DePuy Synthes Anspach Pneumatic Systems User s Manual ATTACHMENTS Caution Manual cleaning instructions for all attachments except the Minimal Access MA attachments and bearing sleeves Detergents e Alkaline detergents with a maximum pH of 11 are recommended for the manual washing of the attach ments e The process detergent and any additives must be discussed with detergent manufacturer Warning Wear eye protectio
52. on of the overall process capability without regard for type or condition of equipment used or methods techniques or practices employed by user Use of proper sterilization indicator de vices is strongly recommended ization processes are directly dependent upon nu merous factors beyond DePuy Synthes Power Tools control including among other things steril ization means processes and wrapping techniques employed brand model and condition of steriliza tion equipment care and maintenance techniques employed and operator knowledge and experience e DePuy Synthes Power Tools cannot anticipate all Anspach Pneumatic Systems User s Manual DePuy Synthes 49 LOADING CONFIGURATION HIGH SPEED HANDPIECES AND ATTACHMENTS Seal Cap CSR60 when not in use a SHORT MEDIUM ES Seal cap installed on connector end of handpiece ANT 4 ele telete jets Me ele te tele A E t hele ler ries 3 lei try b Esty z A i DD RII pis lee ie LONG SAAREN Tee TITL LLL MAA LLLL ma E E Te E E E E E a a E A L Lal ME BESS O O E s H EREEREERED L aa Li IRAN SRS TT EMAX2PLUS or XMAX MIA16 1910810 00 ES BD E A E E AD E 10 1 1 1 E E DD E E E D ET E EA D pe D t D 0 DD E PES E DS T O DEE DN pa SS 1 De S DE 1E e tt tt De e N O e T ITITI TTT YO O JO O O O O O JO ee B D p O ol hol ol ol ol ob ETELE ti LONG HD
53. osure Time Minimum Dry Time Steam Autoclave Pre vacuum Open 1 132 C 4 minutes 30 minutes Wrapped or unwrapped Option 2 134 C 138 C 3 18 minutes 30 minutes Steam Autoclave Gravity Option 1 132 C 15 minutes 30 minutes Air Displacement wrapped or unwrapped Option 2 132 C 138 C 15 18 minutes 30 minutes Warning For STERRAD refer to the accompanying documentation of the individual products to determine compatibility If using the EX BSKT Washing and Sterilization Basket Method Cycle Exposure Temperature Exposure Time Minimum Dry Time Steam Autoclave Pre vacuum Option 1 132 C 4 minutes 20 minutes wrapped or unwrapped Option 2 134 C 138 C 3 18 minutes 20 minutes Steam Autoclave Gravity Option 1 132 C 15 minutes 15 minutes Air Displacement wrapped or unwrapped Option 2 132 C 138 C 15 18 minutes 15 minutes Notes e Foot Controls should not be sterilized e It is required to include the drying cycle to avoid possible adverse effects caused by exposure to residual moisture e Metal devices tools and equipment are con structed of materials unaffected by normal envi ronmental conditions of current standard steril ization means when proper operational techniques are employed Effectiveness of sterilization equipment or steril possible equipment processes and or conditions that may be encountered The suggested operation conditions are to be considered as a starting point for determinati
54. ping or vibration that could cause severe patient injury including death Reprocessed dissection tools may also be duller than new dissection tools resulting in less effec tive use and possible overheating causing necro sis of tissues and or surgeon discomfort e Continued use of dull dissection tools can cause user to apply greater pressure while cutting which can seriously damage attachment and pos sible bearing failure Bearing failure can result in foreign debris entering surgical wound site e iMRI craniotome is constructed of a softer metal than a non iMRI craniotome and excessively ap plied force will cause craniotome leg foot to bend or fracture Do not bend attachment or use cra niotome as a lever Do not force dissection tools Forceful side load may cause dissection tools fracture which could cause injury It can also re sult in handpiece speed reduction and increased temperature 9 During surgical procedure when iMRI is used for actual imaging remove iMRI System and dissection tools from imaging volume Anspach Pneumatic Systems User s Manual DePuy Synthes 15 BLACK MAX STANDARD ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Black Max Dissection Tool Identification All dissection tools are packaged sterile unless other wise indicated and are manufactured for single use Each dissection tool has a series of identification num bers and letters imprinted on the label and on the shaft The first group of l
55. pproximately one quarter turn and remove from distal end of handpiece housing Anspach Pneumatic Systems User s Manual DePuy Synthes 23 MINIMAL ACCESS ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Note Instructions are the same for straight or angled drivers and for straight or curved bearing sleeves in 10 cm 15 cm and 19 cm lengths The four words labeled on the drivers mean the following MA D20 CUTTER Insert or remove dissection tool RUN Attachment and dissection tool are now functional ADJUST Bearing Sleeve can be moved 3 mm M SORIVER forward or back TUBE Insert or remove bearing sleeve Warning The Minimal Access Attachments are to be used only for delicate bone dissection applica tions Excessive force or side loads during use can cause rapid temperature increase at the distal end of the attachment Always use copious irrigation with this attachment MA D20BM 20 Angle Driver for Black Max MA D20 20 Angle Driver for XMAX system MA DRIVER Straight Driver for XMAX system Black Max 20 Angle Driver Installation 1 Ensure locking lever is up 2 Align notch on BM 20 angle driver with RELEASE arrow on handpiece while inserting driveshaft of BM 20 angle driver into handpiece Rotate BM 20 angle driver to right until notch is aligned with SECURE arrow on handpiece Push locking lever down to locked position 3 Gently twist back and forth to ensure driver is locked into position
56. ringe or pipette filled with hot deionized distilled or purified water Figure 11 Place the knurled knob in the RUN position Figure 10 Caution Do not use high pressure water or air Do not immerse Do not allow running water to enter distal end of handpiece Do not place the hose end under running water Figure 11 6 Inspect Visually inspect the handpiece and repeat Steps 2 through 6 until no visible soil remains Warning Manual Precleaning must be followed by mechanical automated cleaning 38 DePuy Synthes Anspach Pneumatic Systems User s Manual ATTACHMENTS Detergents e A neutral pH enzymatic detergent is recommended e Alkaline detergents with a maximum pH of 11 may be used but user must demonstrate their effectiveness e The process detergent and any additives must be discussed with detergent manufacturer Caution Do not use any alkaline detergent with a pH greater than 11 Alkaline detergents attack grease and seals which can increase wear and cause device to malfunction Please note use of alkaline detergents can cause color to fade but this does not impair function of device Warning Do not clean the MA 19ST Minimal Ac cess Bearing Sleeve or attachments not mentioned on page 49 in the EM XM Cleaning and Sterilization Basket 1 Preparation Gather all necessary supplies including Attachment Cleaning Brush ACB Small Diameter Cleaning Brush SDCB sponge lint free cloth an
57. rocess and cycle Caution e Red protective cap for CSR60 and CSR60 BM must be removed prior to sterilization Figure 1 In the case mechanical automated cleaning was done in the EX BSKT seals cap from connector end of pneumatic handpiece must be removed prior to sterilization Figure 2 e Devices must be cleaned prior to sterilization using the validated cleaning method outlined in these instructions Figure 2 Preparation Following cleaning and lubrication load the basket and sterilize in accordance with the following guidelines Load attachments and handpiece in EM XM Cleaning and Sterilization Basket by securing them in appropriate brackets as marked on basket with distal end angled down Replace seal cap in its bracket and lay handpiece con nector in bottom of basket Secure the lid on the basket 48 DePuy Synthes Anspach Pneumatic Systems User s Manual Package for Sterilization When wrapping the basket the lid must be used Double wrap basket or instruments in accordance with local procedures using standard wrap or wrapping tech niques such as those described in ANSI AAMI ST79 Warnings e You must follow manufacturer instructions for any wraps used e Do not use any other sterilization method or cycle than those listed below which have been validated in accordance with ISO 17665 If using the EMAX2 TRAY or XM CASE or BM CASE TR AY Method Cycle Exposure Temperature Exp
58. s which directly affects durability Proper use cleaning maintenance and preoperative inspection will help ensure safe use and prolong useful life of iMRI handpiece and attachments Periodic routine servicing by Anspach Is strongly recommended iMRI dissection tools will dull more quickly than standard dissection tools because they are manufactured of non magnetic reactive material Use with iMRI only During Surgical use you should remain cognizant of cutter per formance and have additional dissection tools available at all times Continued use of dull dissection tools in ad dition to possible necroses may put additional stress on attachment and handpiece leading to premature failure of those devices Before each use assemble system and test to ensure proper performance Proper system performance Is usually indicated when there is no unusual difficulty in attaching attachments and dissection tools and when system operates at full speed unloaded with dissection tools attached with no unusual noise vibration wobble or whipping Caution Carefully inspect handpiece and attach ments postcleaning and again preoperatively to en sure there is no corrosion or remaining debris which could adversely affect operation or lead to at tachment bearing failure during use Continued use of damaged or worn handpiece or at tachments can lead to bearing or other failures which can result in foreign debris entering surgical wound site
59. slowly until dis section tool seats 4 Release latch and check security of attachment by pulling it away from handpiece and check dissection tool by pulling on dissection tool head Latch will be flush with attachment when dissection tool is secure Notes e The operating pressure for these attachments is 40 psi 2 8 bar e Handpiece is now fully functional The first group of upper case letters of the dissection tool part number correspond to the attachment s color coded ring and or name and the last digit represents the dissection tool style For example Black Max Dissection Tool Part Number SIL 8 Dissection Tool Description 8 style dissection tool used with the B SILVER attachment B SILVER B TURQUOISE RG B VIOLET B BLUE S O A B TURQ L B GREY MIA16 _ ____ B BLACK B RED B ORANGE 90 D B ORANGE 45 16 DePuy Synthes Anspach Pneumatic Systems User s Manual Black Max Craniotome and Specialty Attachments Refer to Ordering Information section for part num bers 1 Lift Lever on Black Max Insert dissection tool into handpiece Return Lever to down position Pull dissec tion tool to ensure proper engagement 2 Slide attachment over dissection tool Align notch on attachment with word RELEASE on the Black Max Next turn attachment so notch is aligned with word SECURE 3 The handpiece is now operational Operating pressure is 120 psi 8 3 bar
60. ted and are manufactured for single use Each dissection tool has a series of identification num bers and letters imprinted on the label and on the shaft The first letter describes the type of attachment and the following characters indicate the size and style of the dissection tool For example Dissection Tool Part Number S 2B G1 Dissection Tool Description 2 mm Fluted Ball extended length Each attachment is laser marked with its corresponding part number 18 DePuy Synthes Anspach Pneumatic Systems User s Manual Straight Attachments SHORT 5 cm Short Attachment MEDIUM 8 cm Medium Attachment LONG 11 cm Long Attachment MIA16 16 cm Minimally Invasive Attachment SHORT HD 5 cm Heavy Duty Short Attachment MEDIUM HD 8 cm Heavy Duty Medium Attachment LONG HD 12 4 cm Heavy Duty Long Attachment XL HD 20 2 cm Heavy Duty Extra Long Attachment Assembly for handpieces with m and w Distal end of handpiece or attachment is pointed away from user 1 Move handpiece knurled knob to RUN im position 2 Slide attachment over distal end of handpiece Pull attachment towards handpiece and rotate attach ment to right approximately one quarter turn until fully seated Handpiece knurled knob moves up to seat next to attachment 3 Pull handpiece knurled knob towards LOAD m position and insert dissection tool into distal end of attachment Rotate dissection tool slowly until fully seated 4 Release handpi
61. terilize and or reuse dissec tion tools Use standard protocol for disposal of sharp instruments Continuous extreme cutting at or near stalling conditions will quickly overheat handpiece Do not operate in an explosive flammable environment Do not modify ground or power cord Do not allow liquid into console Do not use in oxygen rich environment Dispose of items contaminated with body fluids or other biohazardous waste At end of life recycle or dispose of device in accordance with local and national regulations Cautions United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider Do not use accessories other than those provided by DePuy Synthes Power Tools and specified for use with DePuy Synthes Power Tools systems Use care to protect hose when handling cleaning and during system use Damage to hose can cause leaking rupture or other related failures Do not step on set equipment on pinch kink clamp or otherwise occlude handpiece hose during use To ensure equipment operates as designed read and fol low manufacturer s instructions Do not operate handpiece without an attachment and the corresponding dissection tool Do not engage safety mechanism while handpiece is running doing so makes safety mechanism inoperable 4 DePuy Synthes Anspach Pneumatic Systems User s Manual TECHNICAL SPECIFICATIONS Black Max Specifications
62. thies TSE DePuy Synthes Power Tools will not au thorize or accept the return of products that directly contact patients or are contaminated with body flu ids of a patient who is suspected or confirmed with a TSE Creutzfeldt Jakob disease TSE CJD diagno sis DePuy Synthes Power Tools recommends that all Anspach products used on a patient confirmed with a TSE CJD diagnosis be incinerated Anspach dissecting tools used on a patient suspected of TSE CJD diagnosis must be incinerated Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment while the original equipment is quarantined Contact the DePuy Synthes Power Tools Customer Service department regarding TSE CJD contamination for additional information Anspach Pneumatic Systems User s Manual DePuy Synthes 31 MANUAL CLEANING HIGH SPEED HANDPIECES Detergents e Neutral pH enzymatic detergents are recommended for the manual washing of the high speed handpieces e Alkaline detergents with a maximum pH of 11 may be used but user must demonstrate their effectiveness e The process detergent and any additives must be discussed with detergent manufacturer Warning Wear eye protection and any additional PPE required Caution Do not immerse Do not insert brush into handpiece housing Do not use saline solution for cleaning Do not use cleaners containing chlori nated phenols of any concentration Usi
63. ttle of Anspach lubricat ing oil filter and muffler have been shipped with the unit and must be added to the AutoLube III prior to use 1 Before adding oil disconnect the AutoLube III from the air source 2 Remove Oil Fill Cap from the top of the AutoLube III and fill with Anspach lubricating instrument oil OIL II Do not fill above the MAX oil level line next to the oil reservoir Always replace the oil fill cap securely One full bottle of Anspach lubricating oil should be added when the oil level reaches the MIN oil level line etched next to the oil reservoir Pressure Relief Valve Oil Fill Cap OIL LEVEL MAX MIN Oil Reservoir Turn handle to open position to insert muffler AutoLube Lubrication Anspach Pneumatic Systems User s Manual DePuy Synthes 9 AutoLube Ill Operating Instructions for Black Max and XMAX 3 4 Before each use a visual check of the oil reservoir should be made to ensure there will be an adequate supply of oil to circulate throughout the procedure Install filter and muffler following AutoLube III Filter section Note Always store and transport AutoLube III in an upright position AutoLube III Filter FILTER II AutoLube ll amp III Filters 5 pkg The filter muffler filter and vented cover have been packed separately in the AutoLube III box The filters should be changed each
64. use de vice to malfunction Please note use of alkaline detergents can cause color to fade but this does not impair function of device e XMAX H may not be cleaned automatically 1 Preparation Gather all necessary supplies including Attachment Cleaning Brush ACB sponge lint free cloth and soft bristle brush Remove the attachment and dissection tool trom the handpiece Figure 1 Figure 1 2 Rinse Rinse the handpiece with distal end pointing down un der running cold deionized distilled or purified water for a minimum of two 2 minutes Use a sponge soft lint free cloth or soft bristle brush to assist in removing gross soils Figures 2 and 3 Caution Do not use high pressure water or air Do not allow running water to enter distal end of hand piece Do not place the hose end under running wa ter Figure 2 Figure 3 Distal End 36 DePuy Synthes Anspach Pneumatic Systems User s Manual 3 Manipulate moving parts Manipulate the handpiece knurled knob under running cold deionized distilled or purified water to loosen or remove gross soil Figure 4 Figure 4 4 Clean Prepare a cleaning solution using neutral pH enzymatic detergent per the manufacturer s directions for correct temperature water quality i e pH hardness and prod uct concentration dilution Spray and wipe the handpiece with the cleaning solution for a minimum of two 2 minutes Rinse the handpie

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