Home

pneumatIc systems

1. 4 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual TECHNICAL SPECIFICATIONS Black Max Specifications Speed Handpiece muffler hose Outside housing diameter Length of housing Handpiece weight Handpiece muftler hose weight XMax Specifications Speed Handpiece muffler hose Outside housing diameter Length of housing Handpiece weight Handpiece muffler hose weight up to 80 000 rom 3 81 m 12 50 ft 19 05 mm 0 75 in 91 44 mm 3 60 in 70 0 g 2 6 02 0 65 kg 1 40 lbs up to 80 000 rom 3 81 m 12 50 ft 17 53 mm 0 69 in 102 36 mm 4 03 in 75 30 g 2 7 oz 0 65 kg 1 45 Ibs This device complies with applicable EEC directives CE 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 iMRI Handpiece Speed Handpiece and Hose Outside Housing diameter Length of Housing Handpiece and hose weight 10 000 75 000 rom 3 81 m 12 50 ft 17 53 mm 0 69 in 101 60 mm 4 00 in 635 00 g 1 41 lb Patent Information DePuy Synthes Power Tools products are manufactured under one or more of the following U S Patent Nos RE 37 358 5 405 348 5 601 560 5 630 818 5 741 084 5 904 687 6 607 533 6 733 218 6 746 153 6 749 341 6 969 368 7 128 544 7 144 415 7 217 090 7 255 546 7 261 526 and 7 458 979 Additional U S an
2. Union Representative Sterilized Using Irradiation Use By Date A K A Do Not Reuse CAUTION Refer to accompanying documentation Keep Dry A K A Protect from Moisture 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 applicable EEC Directives 6 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Glossary of Symbols NTERTE A E Certified Accredited Test House ma Lock Run Unlock Load ge Product warranty is void if seal is damaged gt rr e Or removed Humidity Limits Instrument System Key Black Max IN XMax IIA MRI Latex free Certification Products not made with natural rubber latex Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 7 AUTOLUBE III OPERATING INSTRUCTIONS FOR BLACK MAX AND XMAX ASSEMBLY PROCEDURES OF AUTOLUBE Ill AND HANDPIECE AUTOLUBE lll Foot Control For additional part numbers refer to the Ordering Information section 1 Remove the red plug installed for shipping only from the recirculating bowl located on the top of the AutoLube Il 2 Turn the silver handle located on the back of the AutoLube Il to the OPEN position 3 While maintaining the handle in the OPEN position i
3. 28 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Handheld Attachments Assembly Perforator Driver CSR60BM Perforator Driver with Hudson End for Black Max CSR60 Perforator Driver with Hudson End for XMax 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 speed requirements Note Instructions are written such that distal end of handpiece and attachment are pointed away from user SEED EDUcER 60 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 cranial 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
4. 6 DePuy Synthes MPANIES OF fohmonsfohmon PNEUMATIC SYSTEMS a ed performance and powef a variety of applications K ee gt NANSPACH USER S MANUAL TABLE OF CONTENTS INTRODUCTION DePuy Synthes Power Tools 2 Pneumatic Instrument Systems 2 Indications 3 Warnings and Cautions 4 Technical Specifications 5 Glossary of Symbols 6 OPERATING INSTRUCTIONS AutoLube III 8 Black Max 11 XMax 12 IMRI Instrument System 13 ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Straight Attachments and Dissection Tool Assembly e For Black Max 16 e For XMax 18 Minimal Access Attachments and Dissection Tool Assembly 23 microSaws and Small Attachments Assembly 26 Handheld Attachments Assembly 28 CARE AND MAINTENANCE Cleaning Instructions 30 e Manual Cleaning 31 e Manual Precleaning Before Mechanical 35 Automated Cleaning e Mechanical Automated Cleaning Following 41 Manual Precleaning Inspection and Maintenance 43 Lubrication 46 Sterilization 47 Loading Configuration 49 Troubleshooting 50 Ordering Information 51 Image intensifier control Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools ANSPACH PNEUMATIC SYSTEMS High speed performance and power in a variety of applications DePuy Synthes Power Tools DePuy Synthes Power Tools manufactures pneumatic and electric high performance instruments and attachments to meet the specific needs of both surgeon
5. III FFG7 AUTOLUBE III IRR AUTOLUBE IIIF MA7 AUTOLUBE IIIF NK AUTOLUBE III 20 AL III 30 AL III DISS 30 FILTER II OIL Il HOSE HOSE 5 HOSE 10 HOSE 10 DISS HOSE 15 DISS HOSE 20 DISS HOSE DISS B CASE TRAY MM CTR RACK XM CASE PG SCHRADER F 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 ll and Ill Filters 5 pkg Instrument Oil w 1 Replacement Filter for AutoLube II and Ill 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 Cutting Burr Rack Sterilization Case with Tray Pistol Grip tor Black Max SCHRADER Adapter Female 52 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual EN ANSPACH Limited Warranty and Disclaimer The Anspach Effort Inc products are sold with a limited wa
6. Lever on Black Max handpiece to down position NO Ow fs Uy 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 B QD11 B QD14 Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 17 XMAX STANDARD ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Straight Attachment Assembly Handpiece XMax Retaining Sleeve Straight Attachment Dissection Tool ANSPACH Craniotome Attachment Assembly Handpiece XMax Retaining Sleeve Dissection Tool Craniotome Attachment ANSPACH Dissection Tool Identification All dissection tools are packaged sterile unless otherwise indicated and are manufactured for single use Each dissection tool has a series of identification numbers 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 Dissection Tool Description 2 mm Fluted Ball for Short attachment Each attachment is laser marked with its corresponding part number 18 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual XMax Standard Attachments and Dissection Tool Assembly Straight Attach
7. Tool Assembly QD Angle Attachments QD8 8 cm Quick Disconnect Angle Attachment QD11 11 cm Quick Disconnect Angle Attachment QD14 14 cm Quick Disconnect Angle Attachment Assembly for Handpieces with m and wm 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 attachment 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 position 4 Insert dissection tool into angle attachment Rotate dissection tool slowly until it is fully seated Release retaining sleeve on angle attachment by rotating retaining sleeve to right to the SECURE position Note Handpiece is now fully functional 5 Pull dissection tool to ensure proper engagement 6 Attachment and 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 Move handpiece knurled knob to SAFE position 4 Rotate attachment to left approximately one quarter turn and remove from distal end of handpiece UU QD8 QD14 22 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manu
8. 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 dissection tools should be used with the XMax Warning Always use continuous irrigation to prevent heat build up Always wear safety glasses XMax Directional Arrows Notice the directional arrows and printing on the distal end of the handpiece housing RUN im LOAD m and SAFE These terms refer to locking and unlocking the attachment and dissection tool onto the handpiece Figure 1 For instructions on attachment assembly refer to the specific instructions for each attachment in this manual Directional Arrows Distal End s Motor Housing Handpiece Knurled Knob Attachment Connection Figure 1 12 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual IMRI INSTRUMENT SYSTEM MRI Instrument System IMRI MOTOR IMRI Motor IMRI FOOT CTRL iMRI Air Control IMRI SHORT IMRI Short Attachment IMRI SHORT HD iMRI Short HD Attachment IMRI CRANI A iMRI Crani A Attachment IMRI OIL IMRI Synthetic Oil For additional components refer to page 40 Use Care and Operating Instructions Warning Do not use any attachments or dissection tools with iMRI handpiece not
9. and product concentration dilution Fully immerse the attachment in cleaning solution in a suitable container and manually agitate for 2 minutes Figure 6 Use r EE E ERA a sponge soft lint free cloth or soft bristle brush to remove Figure 6 Figure 7 all visible soil Gently 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 attachment 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 Minimal 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 proximal end of the bearing sleeve Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 39 Manual Precleaning Before Mechanical Automated Cleaning Attachments 3 Rinse thoroughly Rinse the attachment thoroughly under running hot deionized 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 solut
10. are disposable and intended for single patient use only Do not resterilize and or reuse dissection 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 Irrigation Tubes contain DEHP a type of phthalate 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 specitied 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 follow 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
11. for handpieces with m and m 1 Remove red storage cover 2 Move handpiece knurled knob to RUN al position 3 Slide Perforator Driver over distal end of handpiece Pull Speed 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 handpiece Insert Hudson end of cranial perforator and release retaining sleeve Disassembly 1 Pull Perforator Driver retaining sleeve towards handpiece 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 handpiece 4 Replace red storage cover Note The red storage cap provided with the Perforator Driver is to prevent damage to the shaft The cap is removed for cleaning washing and sterilization The cap is used for storage purposes only Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 29 CLEANING INSTRUCTIONS PNEUMATIC HIGH SPEED SYSTEMS The following manual cleaning and mechanical automated cleaning with manual Precleaning instructions have been val idated by Anspach for preparing a nonsterile medical device this instruction is provided in accordance with ISO 17664 2004 and ANSI AAMI ST81 2010 Warning Transmissible spongi
12. is one of the quietest pneumatic handpieces available with 35 more power than Black Max and 50 more than microMax Plus The Black Max operating at 80 000 rpm 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 for use with field strengths up to 1 5 Tesla J z LA Spine surgery Neurosurgery otology and neurotology 2 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual INDICATIONS XMax Cutting and shaping bone Black Max Cutting and shaping bone iMRI Surgical Drill System The Anspach iMRI Surgical Drill System including pneumatic drill motor foot control nosepiece attachments and cutters is indicated for intraoperative non imaging use within a Magnetic Resonance Imaging MRI environment rated at 1 5 Tesla or less for surgical cutting shaping and removal of bone including bones of the skull and spine Black Max XMax BANSPACH iMRI Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 3 WARNINGS AND CAUTIONS Warnings A Irrigation is necessary for proper operation Surgeon is responsible for learning proper techniques in use of
13. manufactured by Anspach 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 materials that permit intraoperative use in an intraoperative magnetic resonance imaging unit rated at 1 5 Tesla or less and only when intraoperative magnetic resonance imaging is not being used for actual imaging purposes Caution Do not use in intraoperative magnetic resonance 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 iMRI System as established by ASTM F2213 02 Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in Magnetic Resonance Environment and F2052 02 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in Magnetic Resonance Environment confirm there is no detectable magnetically induced torque on handpiece at 1 5 Tesla w
14. B BLUE S B MRA S B MRA M f B MRA L B TURQ L dl B GREY MIA16 M B BLACK i B RED B ORANGE 90 ef B ORANGE 45 ly _ 16 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Black Max Standard Attachments and Dissection Tool Assembly Black Max Craniotome and Specialty Attachments Refer to Ordering Information section for part numbers 1 Lift Lever on Black Max Insert dissection tool into handpiece Return Lever to down position Pull dissection 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 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 attachment 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 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
15. CB MA 15C MA 15ST and MA 19ST Note Please refer to cleaning instructions provided with the MA attachments Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 33 Manual Cleaning 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 34 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual 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 e Do not use any alkaline detergent with a pH gr
16. 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 105 Bearing Sleeve 10 cm Straight MA 10C Bearing Sleeve 10 cm Curved ORANGE 45 45 Contra Angle Attachment ORANGE 90 90 Right Angle Attachment QD8 8 cm Quick Disconnect Angle Attachment QD8 S 7 5 cm Quick Disconnect Angle Attachment QD11 11 cm Quick Disconnect Angle Attachment QD11 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 microS
17. QD14 S e MA D20 e MA D20BM e MA DRIVER Craniotomes e B TURQ X e B GOLD e B GREEN e B GREEN R e CRANI A e CRANI A R e CRANI L e CRANI L R e CRANI P Visually inspect for any damage to the tube eee Short Visually inspect for bent or broken drive shaft and for any damage to the tube QD8 Visually inspect for bent or broken foot CRANI A Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 43 Inspection and Maintenance Other Attachments ADG B GREY ADG B TURQ CDA B ORANGE 90 B ORANGE 45 BM DRIVER CSR6E0BM CDA CSR6E0 DRIVER MDA ORANGE 45 ORANGE 90 O SAW R SAW S SAW SA JACOBS SA JLATCH Foot Controls All AutoLube Models Visually inspect for overall damage or missing components CSR60 Visually inspect tor damage to the hose Visually inspect for damage to the housing or pedal 44 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Inspection and Maintenance Handpiece Ensure that the knurl knob operates properly s XNA e f the knob is hard to turn it may be lubricated Please refer to the instructions for use e XMax H e BLACKMAX N Visually inspect for damage to the silicone hose e BLACKMAX N LP Connect to foot control and operate The handpiece should operate smoothly e There is no requirement to operate with attachment or dissection tool Anspach Pneumatic Systems User s Manual DePu
18. User s Manual microSaws and Small Attachments Assembly J Latch and Keyless Jacobs Chuck Attachment Assembly Jacobs Chuck J latch Chuck SA JACOBS SA JLATCH 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 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 alignment J Latch Dissection Tool Assembly 1 Pull back distal sleeve in direction of arrow on SA JLATCH attachment and hold it down to insert dissection tool into distal end of attachment 2 Rotate dissection tool slowly until fully seated 3 Release distal sleeve and check security of dissection tool by pulling distally on dissection tool 4 Dissection tool and attachment are secure J Latch Dissection Tool Removal 1 Pull back distal sleeve in the direction of arrow 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 of release button located on SA JACOBS attachment wh
19. User s Manual XMax Standard Attachments and Dissection Tool Assembly Craniotome and Specialty Attachments CRANI P CRANI P 6 5 cm Pediatric Craniotome CRANI A 6 5 cm Adult Craniotome CINTA 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 CRANLA R Assembly for handpieces with m and m Distal end of handpiece or attachment is pointed away ADG from user CDA 1 Pull handpiece knurled knob towards LOAD m position and insert dissection tool into distal end of handpiece Rotate dissection tool slowly until dissection tool is fully seated 2 Release handpiece knurled knob into RUN im position Note Handpiece is now fully functional 3 Pull dissection tool to ensure proper engagement 4 Slide attachment over distal end of handpiece Pull attachment towards handpiece and rotate attachment to right approximately one quarter turn until fully seated Handpiece knurled 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 Power Tools 21 XMax Standard Attachments and Dissection
20. ach Pneumatic Systems User s Manual BLACK MAX OPERATING INSTRUCTIONS 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 prevent heat build up Always wear safety glasses 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 located 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 properly 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 Lever Attachment Connection Motor Housing Handpiece Distal End O ERNEJER gt AYNOAS gt Cutter The location of the lever determines the lock and release of the cutter Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 11 XMAX OPERATING INSTRUCTIONS The XMax Handpieces
21. al 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 DAS CUTTER Insert or remove dissection tool RUN Attachment and dissection tool are now functional ADJUST Bearing Sleeve can be moved 3 mm forward or back TUBE Insert or remove bearing sleeve ida Warning The Minimal Access Attachments are to be used only for delicate bone dissection applications 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 MA DRIVER Stralght Driver for XMax 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 XMax Driver Installation 1 Ensure handpiece is in RUN im 2 Insert driveshaft of driver into distal end of handpiece push and rotate to right until it stops Li
22. and staff While the advanced design of these instruments provides unparalleled performance and reliability they also allow for effortless assembly for the most demanding applications No tools are required to assemble dissection tools or attachments All DePuy Synthes Power Tools instruments are manufactured to conform to rigorous quality standards to provide 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 operating manual The surgeon is responsible for learning the proper techniques in the use of this system as improper use may cause injury To schedule a hands on training course elther at DePuy Synthes Power Tools or trom your local DePuy Synthes Power Tools Sales Representative call 800 327 6887 or 561 627 1080 If you have any questions after reading this manual please call the DePuy Synthes Power Tools Customer Service Department at 800 327 6887 or 561 627 1080 High Speed Pneumatic Systems The XMax System sets a new standard for the ultimate 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 complete range of surgical procedures ranging from power demanding applica tions to the most delicate dissection With a minimum speed of 80 000 rpm at 120 psi 8 3 bar input pressure the XMax system
23. andpiece 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 m Distal end of handpiece or attachment Is pointed away from user 1 Remove red storage cover Move handpiece knurled knob to RUN fa 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 NS 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 position
24. ap Oil Reservoir AutoLube III Lubrication Max Oil Level Min Oil Level Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 9 AutoLube Ill Operating Instructions Assembly Procedures of AutoLube lll and Handpiece AutoLube Lubrication continued 3 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 4 Install filter and muffler following AutoLube III Filter section Note Always store and transport AutoLube III in an upright position AutoLube III Filter FILTER I AutoLube II and Ill Filters 5 pkg The filter muffler filter and vented cover have been packed separately in the AutoLube Ill box The filters should be changed each time a bottle of Anspach lubricating oil is added 1 Insert the filter by taking the tab and sliding the horseshoe shaped portion of the filter into the cavity in a downward motion The tab will extend out of the cavity 2 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 Tit 3 Place the vented cover over the filter cavity and secure by turning the grey wingnut in a clockwise direction AutoLube III Filter Vented Cover Insert filter with a downward motion 10 DePuy Synthes Power Tools Ansp
25. aw 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 16cm 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 0D11 S 10 5 cm Angle Attachment B 0D14 14 cm Angle Attachment B QD14 S 13 5 cm Angle Attachment MA D20BM 20 Angle Driver MA 155 Bearing Sleeve 15 cm Straight MA 15C Bearing Sleeve 15 cm Curved MA 105 Bearing Sleeve 10 cm 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 E
26. d International patents pending Additional Information All specifications are subject to change Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 5 GLOSSARY OF SYMBOLS 30 Sec ON 30 Sec OFF X gt gt E lt gt 3MM gt Amm gt 5uu gt Gmm gt CUTTER gt RUN ADJUST TUBE gt SECURE RELEASE 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 setting 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 Direction of rotation Located on the Handpiece this indicates position of the knurl knob to the desired location Symbol with yellow background CAUTION Refer to accompanying documentation lil Consult Operating Instructions Temperature Limits REF D tail 00 0000 EC BA gt ONLY sw CE 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
27. d 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 mounting 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 Tully 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 counterclockwise until attachment is released 26 DePuy Synthes Power Tools Anspach Pneumatic Systems
28. 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 1 Move handpiece knurled knob to SAFE position 2 Rotate attachment to left approximately one quarter turn and remove from distal end of handpiece 24 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual MICROSAWS AND SMALL ATTACHMENTS ASSEMBLY The microSaws were designed for small bone dissection BM DRIVER The microSaw Drivers provide direct connection to Black Max and XMax The Drivers also enable rapid exchange of saw head styles through a unique quick disconnect system Keyless Driver Installation DRIVER Black Max Keyless Driver Installation BM DRIVER Keyless Driver 1 Ensure locking lever is up 2 Align notch on keyless driver with RELEASE arrow on BN ORE ee WERDay ye handpiece while inserting drive shaft of Keyless Driver 30 Sec ON 30 Sec OFF for 8 cycles into handpiece Rotate keyless driver clockwise until notch is aligned wit
29. dpiece 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 Ill Operating Instructions 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 slowly until dissection tool seats 4 Release latch and check security of attachment by pulling it away trom 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 A B SILVER B TURQUOISE gt B VIOLET gt
30. e can damage the sight window resulting in oil leakage 3 Connect muffler end of hose to foot control and inspect handpiece to ensure it is IMRI and that internal 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 dissection 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 Verity locking by pulling on attachment 5 Select appropriate dissection tools and following all established sterile techniques remove it from Its packaging insert it into and through attachment into handpiece and lock into place Verity locking by pulling on dissection tools If using craniotome dissection tool should be put into handpiece first then put craniotome 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 difficulty and handpiece sounds and feels right initiate or continue with use 8 During procedure c
31. eater 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 e XMax H may not be cleaned automatically 1 Preparation Assemble 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 under 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 3 and 4 Caution Do not use high pressure water or air Do not allow running water to enter distal end of handpiece Do not place the hose end under running water pe Figure 3 Figure 4 Distal End Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 35 Manual Precleaning Before Mechanical Automated Cleaning High Speed Handpieces 3 Manipulate Moving Parts Manipulate the handpiece knurled knob under running cold deionized distilled or purified water to loosen or remove gross soil Figure 5 Figure 5 4 Clean Prepare a cleaning solution using neutral pH enzymatic detergent per the manufacturer s directions for correct temperature wat
32. echanical 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 connector in bottom of basket Secure the lid on the basket Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 47 Sterilization High Speed Handpieces and Attachments 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 techniques such as those described in ANSI AAMI ST79 If using the EMAX2 TRAY or XM CASE or BM CASE TRAY Warnings You must follow manufacturer s 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 Method Cycle Exposure Temperature Exposure Time Minimum Dry Time Steam Autoclave Pre vacuum Option 1 132 C 4
33. equipment improper use may cause serious injury to user or patient 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 packaging 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 equipment 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 utilized 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 Forceful side loading of dissection tool may cause fracture of dissection tool which may cause injury Dissection tools
34. er quality i e pH hardness and product concentration dilution Spray and wipe the handpiece with the cleaning solution for a minimum of two 2 minutes Rinse the handpiece thoroughly under running cold deionized distilled or purified water for a minimum of two 2 minutes while manipulating the knurled knob Figures 6 and 7 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 8 Hold the handpiece at a downward angle and insert the Anspach Cleaning Brush ACB wetted with cleaning solution into the distal end of the handpiece Figure 9 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 water 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 Figure 6 Figure 7 Figure 8 Figure 9 36 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Manual Precleaning Before Mechanical Automated Cleaning High Speed Handpieces 3 Rinse Thoroughly Rinse the handpiece thoroughly under running hot deionized distilled or purified water for a minimum of 2 minutes Figure 10 Place locking mechanism in SAFE position prior t
35. eve or attachments not mentioned on page 49 in the EM XM Cleaning and Sterilization Basket 1 Preparation Assemble all necessary supplies including Attachment Cleaning Brush ACB Small Diameter Cleaning Brush SDCB sponge lint free cloth and 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 Figure 1 Figure 2 should be used for nonsterile storage purposes only 2 Rinse Rinse the attachment under 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 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 38 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Manual Precleaning Before Mechanical Automated Cleaning Attachments 3 Manipulate Moving Parts Manipulate all moving parts such as release sleeves under running cold deionized distilled or purified water to loosen or remove gross soil Figure 5 Figure 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
36. form encephalopathies TSE DePuy Synthes Power Tools will not authorize or accept the return of products that directly contact patients or are contaminated with body fluids of a patient who is suspected or confirmed with a TSE Creutzfeldt Jakob disease TSE CJD diagnosis DePuy Synthes Power Tools recommends that all Anspach products used on a patient confirmed with a TSE CJD diagnosis be inciner ated 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 30 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual 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 chlorinated phenols of an
37. gure 1 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 Pre wash 1 minute 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 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 remains Remove seal cap from connector end of handpiece and drain until no visible droplets are coming from the handpiece or connector 42 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual INSPECTION AND MAINTENANCE Perform these activities regularly as per institution policy Warning Do not use any damaged equipment Return to DePuy Synthes Power Tools repair facility Attachments Straight Attachments e B SILVER e LONG e B TURQUOISE e LONG S e B VIOLET e LONG 01 e B BLUE S e LONG HD e B MRA S e MEDIUM e B MRA M e MEDIUM HD e B MRA L e MIA16 e B TURQ L e SHORT e B BLACK e SHORT HD e B RED e XL HD Angle Attachments e B QD8 e QD8 e B QD8 S e QD8 S e B QD11 e QD11 e B QD11 S e QD11 S e B QD14 e QD14 e B QD14 S e
38. h SECURE arrow on handpiece The recommendations for times of use for the DRIVER Push locking lever down to locked position attachments have been determined under average load and worst case ambient air temperature of 85 F 29 C Disassembly 1 Raise locking lever 2 Rotate BM DRIVER counterclockwise and remove trom handpiece XMax 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 Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 25 microSaws and Small Attachments Assembly 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 When fully engaged contours on keyless driver body release ring an
39. hen 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 IMRI System Is designed for surgical procedures typically involving no more than 15 minutes of continuous actively drilling operation If a procedure is expected to last longer you should be aware handpiece speed and temperature may be affected Normal speed of MRI System will be less than XMax due to magnetic effects and because IMRI System does not have continuous oiling The lower speed will not adversely affect 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 geometry has been slightly modified to prohibit attachment of non iMRI handpiece compatible devices Anspach Pneumatic System
40. ile rotating knurled knob on attachment clockwise until fully opened 2 Insert dissection tool into distal end of attachment until 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 SA JLATCH SA JACOBS Keyless Jacobs Chuck Dissection Tool Removal 1 Press down on center of release button located on SA JACOBS attachment while rotating knurled knob on attachment clockwise until fully opened 2 Pull dissection tool out distally for removal 3 Release button Disassembly microSaw and Small Attachment Removal 1 With one hand supporting attachment rotate release ring on keyless driver or e12 handpiece with other hand counterclockwise until attachment is released Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 27 HANDHELD ATTACHMENTS ASSEMBLY Sagittal Saws B SAGITTAL MM SAGITTAL Black Max Sagittal Saw Sagittal Saw for XMax 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 of h
41. ion 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 40 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual MECHANICAL AUTOMATED CLEANING FOLLOWING MANUAL PRECLEANING 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 mechanical 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 Ca
42. ments 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 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 attachment 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 handpiece knurled knob into RUN il 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 from distal end of handpiece SHORT EP i MEDIUM LONG MIA16 SHORT HD tied MEDIUM HD i LONG HD ee lw XL HD a at An
43. 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 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 consoles and irrigation pumps 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 constructed of materials unaffected by normal environmental conditions of current standard sterilization means when proper operational techniques are employed e DePuy Synthes Power Tools cannot anticipate all e Effectiveness of sterilization equipment or sterilization processes are directly dependent upon numerous factors beyond DePuy Synthes Power Tools control including among other things sterilization means
44. nd SA JACOBS Small Attachment Jacobs Chuck SA JLATCH Small Attachment J Latch Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 51 Ordering Information 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 IRR CLIP 10 IRR CLIP 20 IRR CLIP 30 IRR CLIP 40 IRR CLIP 50 IRR CLIP 60 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 Irrigation Clip for SHORT Irrigation Clip for QD8 QD8 S B QD8 Irrigation Clip for SHORT HD B SILVER Irrigation Clip for MEDIUM HD LONG HD B BLUE S B VIOLET Irrigation Clip for MEDIUM LONG LONG S B TURQ L Irrigation Clip for QD11 QD11 S QD14 QD14 S B QD11 B QD11 S B QD14 B QD14 S Pneumatic Handpieces BLACKMAX N BLACKMAX N LP XMax Swivel Angle Handpiece Low Pressure Swivel Angle Handpiece XMax Handpiece Pneumatic Accessories ACB SDCB AL III IRR MA7 AUTOLUBE III AUTOLUBE III DISS AL III DISS 20 AUTOLUBE III FG AUTOLUBE
45. nd 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 soeed unloaded with dissection tools attached with no unusual noise vibration wobble or whipping Caution Carefully inspect handpiece and attachments postcleaning and again preoperatively to ensure there is no corrosion or remaining debris which could adversely affect operation or lead to attachment bearing failure during use Continued use of damaged or worn handpiece or attachments can lead to bearing or other failures which can result in foreign debris entering surgical wound site Never reprocess or reuse iMRI dissection tools iMRI dissection tools must be properly disposed of after a single use 14 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual IMRI Instrument System 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 3 drops of IMRI OIL into muffler end of iMRI handpiece hose assembly Do not exceed three 3 drops Caution iMRI OIL is for use with iMRI handpiece only Do not use with other Anspach AutoLube systems iMRI OIL used in AutoLub
46. nnulations must be pre cleaned with appropriate brushes as described in Precleaning instructions e Devices must not be cleaned using ultrasonic equipment 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 must be cleaned immediately after use to ensure 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 Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 41 Mechanical Automated Cleaning Following Manual Precleaning High Speed Handpieces and Attachments 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 downward Warning Red protective cap for Perforator Driver must be left off during mechanical automated cleaning 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 Fi
47. nsert the muffler end of the pneumatic handpiece into the cavity located on top of the recirculating bowl 4 Insert the muffler until the red ring on the muffler cannot be seen 5 Rotate silver handle to the LOCK position Check for secure engagement Operating Pressure Anspach pneumatic handpieces run on air or medical grade nitrogen Standard operating pressure is 90 120 psi 6 2 8 3 bar If more or less power Is desired the psi may be regulated between 40 and 140 psi 2 8 and 9 6 bar 1 Connect the air hose from the AutoLube lll to the hospital air source nitrogen tank or hospital nitrogen system 2 Adjust the air source until the desired air pressure registers on the gauge of the AutoLube Ill Pressure will not register on the AutoLube lll until the muffler is inserted and the foot pedal Is activated 3 The wall nitrogen tank pressure may read as much as 40 psi higher than the AutoLube Ill gauge 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 1 Red Plug Oil Fill Cap Recirculating Bowl Pressure Gauge P Os Gall a a ari Handle 3 Red Ring inserts 4 fully in
48. o performing the following step Figure 11 Hold the handpiece at a downward angle and flush inside of the distal end using a syringe or pipette filled with hot deionized distilled or purified water Figure 12 Place the knurled knob in the RUN position Figure 11 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 la Figure 10 Figure 12 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 Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 37 Manual Precleaning Before Mechanical Automated Cleaning 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 Access Bearing Sle
49. ontinuously assess cutting effectiveness 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 effectiveness stop and replace dissection tools Warnings e Do not reprocess or use reprocessed dissection tools iMRI dissection tools are constructed of stainless steel that is subject to dulling and possible distortion during initial use Reprocessors may not be able to reprocess dissection tools to their original design condition and reuse could result in excessive whipping or vibration that could cause severe patient injury including death Reprocessed dissection tools may also be duller than new dissection tools resulting in less effective use and possible overheating causing necrosis 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 possible 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 applied force will cause craniotome leg foot to bend or fracture Do not bend attachment or use craniotome as a lever Do not force dissection tools F
50. orceful side load may cause dissection tools fracture which could cause injury It can also result 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 Power Tools 15 BLACK MAX STANDARD ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Black Max Dissection Tool Identification All dissection tools are packaged sterile unless otherwise indicated and are manufactured for single use Each dissection tool has a series of identification numbers and letters imprinted on the label and on the shaft The first group of letters 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 numbers 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 3 Pull dissection tool to ensure proper engagement 4 Adjust air source until desired air pressure registers on AutoLube gauge Notes e Air pressure will not register until foot pedal is depressed e Han
51. processes and wrapping techniques employed brand model and condition of sterilization equipment care and maintenance techniques employed and operator knowledge and experience possible equipment processes and or conditions that may be encountered The suggested operation conditions are to be considered as a starting point for determination 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 devices is strongly recommended It is recommended that a drying cycle be included to avoid possible adverse effects caused by exposure to condensation 48 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual LOADING CONFIGURATION HIGH SPEED HANDPIECES AND ATTACHMENTS Seal Cap when not in use Seal cap installed on connector end of handpiece SHORT MEDIUM LONG NN qi FE Shee ele le E epi lo o Js ES a al ka ee teja H ar seit RRA Sandaun D 1 18 il r m ibe a E JABES HE E 3 pr q MA mt 1 1 e p arikat Aant rine i MA Bearing Sleeves excluding MA19 ST MA D20 eee de A an re a J dass UE Helge EN al i LLELE HETE CSR60 T_T EILL o LL CE SEEL E Bann Tr e Ln 7 See eee aaa MAMA AE 80 i m 4 Shi _ men BEESERERS TAT f
52. rranty to the original purchaser against defects in workmanship and materials Any other express or implied warranties including warranties of merchantability or fitness are hereby disclaimed Please contact Customer Service for full Warranty statement WARNING In the USA this product has labeling limitations See package insert for complete information CAUTION USA Law restricts these devices to sale by or on the order of a physician To order in the US call DePuy Synthes Power Tools Customer Service 800 327 6887 Not all products are currently available in all markets 6 DePuySynthes 22 2 00 04 ___ POWER TOOLS COMPANIES OF fohmonsfohmon wal ECIREP a Manufacturer Anspach Europe Ltd The Anspach Effort Inc Aston Court Kingsmead Business Park 4500 Riverside Drive Frederick Place High Wycombe Palm Beach Gardens FL 33410 HP 11 1LA United Kingdom USA Telephone 441 494 616126 Tel 800 327 6887 Fax 441 494 616001 Fax 561 627 1265 Email infoPowerTools DPYUS jnj com www depuysynthes com DePuy Synthes Power Tools a division of DOI 2013 All rights reserved J11813 B 11 13 19 0021A
53. s User s Manual DePuy Synthes Power Tools 13 IMRI Instrument System IMRI Instrument System continued 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 recommended number of uses Metal component parts of iMRI handpiece and attachments and all MRI dissection tools are constructed of materials mostly unaffected by magnetic properties of MRI However these materials have significantly less hardness 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 nonmagnetic reactive material Use with iMRI only During surgical use you should remain cognizant of cutter performance and have additional dissection tools available at all times Continued use of dull dissection tools in addition to possible necroses may put additional stress on attachment and handpiece leading to premature failure of those devices Before each use assemble system a
54. spach Pneumatic Systems User s Manual DePuy Synthes Power Tools 19 XMax Standard Attachments and Dissection Tool Assembly Orange 45 or 90 Contra and Right Angle Attachments ORANGE 45 ORANGE 45 45 Contra Angle Attachment 5 N ORANGE 90 90 Right Angle Attachment A 7 Caution Set AutoLube operating pressure to 40 psi 2 8 bar ORANGE 90 A Assembly for handpieces with m and m 1 Ensure knurled knob on handpiece is in RUN im position 2 Slide attachment over distal end of handpiece Push attachment towards handpiece and rotate attachment 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 handpiece 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 Power Tools Anspach Pneumatic Systems
55. st hard surface until debris is dislodged e Lift lever tap distal tip of handpiece against hard surface until dissection tool is dislodged XMax knurled knob will not secure e Broken dissection tool in handpiece e Dissection tool not seated properly e Debris built up inside handpiece e Reassemble dissection tool and attachment e Remove attachment and tap distal tip of handpiece against hard surface until debris is dislodged e Remove attachment and tap handpiece against hard surface until dissection tool is dislodged Attachment is hot e Possible bearing damage e Debris lodged inside attachment e Clean attachment using Anspach attachment cleaning instructions located in this manual e Return attachment to DePuy Synthes Power Tools for service Craniotome attachment is bent e Excessive force used in operation e Do not use replace attachment Inoperative foot control e Faulty air connection e AutoLube was sterilized or submerged in fluids e Water in the AutoLube e Oil leaking out of AutoLube e Replace AutoLube filter check oil level Do not overfill AutoLube e Check connection at air source e Return to DePuy Synthes Power Tools tor service e Return to DePuy Synthes Power Tools tor service 50 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual ORDERING INFORMATION XMax Attachments SHORT 5 cm Short Attachment MEDIUM 8 cm Medium Attachment LONG 11 cm
56. sten 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 Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 23 Minimal Access Attachments and Dissection Tool Assembly Bearing Sleeve and Dissection Tool Assembly BM 20 Angle Driver 20 Angle Driver or Straight Driver MA 105 Bearing Sleeve 10 cm Straight MA 10C Bearing Sleeve 10 cm Curved MA 15S 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 tio of bearing sleeve Rotate dissection tool slowly until it is fully seated Rotate 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 Dissection Tool Disassembly 1 Rotate knurled knob on driver to line up arrow with CUTTER Remove
57. t manufacturer Warning Wear eye protection 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 attachments is for OR personnel only 1 Preparation Assemble all necessary supplies including Attachment Cleaning Brush ACB sponge lint free cloth and soft bristle brush Remove the attachment and dissection tool from the handpiece Figure 1 CSR60 and CSR60 BM only The red storage cap provided with the Perforator Driver is to prevent damage to the shaft The cap is removed for cleaning washing and sterilization 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 prepared as described on the product label at room temperature in a suitable container and agitate for 15 seconds Figure 3 Figure 1 Figure 2 Figure 3 32 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual Manual Cleaning Attachments 3 Clean Cannulations Caution This step refers ONLY to
58. the following attachments for other attachments proceed to step 4 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 CRANI A CRANI A R CRANI A 01 CRANI P CRANI L CRANI L R B TURQ X B GOLD B GREEN B GREEN R Specialty Attachments ADG B GREY ADG B TURQ CDA CDA QD Attachments QD8 QD8 S QD11 QD11 S QD14 QD14 S B QD8 B QD8 S B QD11 B QD11 S B QD14 B QD14 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 Figure 4 Rinse Rinse the attachment in a suitable container filled with deionized distilled or purified water and agitate for 15 seconds Cleaning Instructions for Minimal 9 Access MA Attachments Inspect Minimal Access Drivers MA D20 MA 20BM MA DRIVER Repeat Steps 2 4 until there is no evidence of soils or Minimal Access Bearing Sleeves MA 10S MA 10C MA 15S residuals on the attachment surface or A
59. to Recirculating Bowl Locked Position 8 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual AutoLube Ill Operating Instructions Assembly Procedures of AutoLube lll and Handpiece 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 remove the source of the occlusion Do not attempt to disassemble the pressure relief valve AutoLube Lubrication OIL Il_ Instrument Oil with 1 Replacement Filter Note The AutoLube III has been delivered without oil or a filter installed A bottle of Anspach lubricating 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 Ill from the air source 2 Remove Oil Fill Cap from the top of the AutoLube lll and fill with Anspach lubricating instrument oil OIL Il 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 Ca St Yo f qs WES Ds Turn handle to open position to insert muffler Oil Fill C
60. uel a EMAX2PLUS or XMax MIA16 AGA AE li Jili 1 E SS Jl 21 eh 0 o 0 A LL EE 0 E O E DE O ttt E 0 FEE TE ttt tts DELL Vitti eae jae lie 0 O O O OS 0 O IO SS A O A E ELUTEEL IET AA Ore a O E 1 a See eee RAMA ANA AAA TT mn CCC CC T o r T rae m i i CL ENE A iS CA F 7 F a AE p N j A ASA a A AAA QD8 QD11 LONG HD e E e E A E WENA s e eran do MEDIUM HD SHORT HD hr HHHRRANNT HE IDAE BERPA RI E cd ol oll a ln Pi Ml Bein el OE BARRA Ti Lit TOGS pza Ll IN RARA i PCIE ld a a S wm in ah i A si m e ILERE r e a Pb Vdd ab Peal abe Wale AE waa a ba MANE Pida mi recta FR loser Rey iras a rd rd er weet Fre le a he eet el et A A dd di dd a CRANI P CRANI A CRANI L Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 49 TROUBLESHOOTING PNEUMATIC HANDPIECES BLACK MAX AND XMAX Problem Possible Cause Solution Lack of power or e Inadequate lubrication excessive handpiece noise e Inadequate operating pressure e Muffler not connected properly e Handpiece hose damaged e Faulty internal component e Pressure Relief Valve activated e Add OIL Il to AutoLube e Check pressure on AutoLube Extra long extension hose trom air source could reduce operating pressure e Check Schrader connection e Check for handpiece hose occlusion e Check connection between muffler and A
61. utoLube Muffler must be inserted past red line e Return to DePuy Synthes Power Tools tor service e Return to DePuy Synthes Power Tools tor service e Check for handpiece occlusion remove the source of the occlusion Return to DePuy Synthes Power Tools for service Handpiece does not rotate e Handpiece stalling when foot pedal is activated Faulty attachment e Handpiece lock engaged e Faulty internal component e Rotate dissection tool then activate foot pedal e Clean or replace attachment e Unlock handpiece e Return to DePuy Synthes Power Tools tor service Handpiece vibration or extremely hot e Inadequate lubrication e Handpiece out of balance e Add Anspach oil to AutoLube e Return to DePuy Synthes Power Tools for service Excessive vibration of dissection tool e Dissection tool may be bent e Improper attachment and dissection tool combination e Possible attachment bearing damage e Dissection tool may not be fully seated e Replace with new dissection tool e Reassemble dissection tool and attachment e Only use correct dissection tool with appropriate attachment e Return attachment to DePuy Synthes Power Tools for service Black Max Lever will not lower e Broken dissection tool in handpiece e Dissection tool not seated properly e Debris built up inside handpiece e Reassemble dissection tool and attachment e Remove attachment lift lever and tap distal tip of handpiece again
62. y Synthes Power Tools 45 LUBRICATION HANDPIECES Do not lubricate handpieces ATTACHMENTS Caution This step is for attachments only 1 Immerse in Lubricant After cleaning and rinsing fully immerse the attachment in instrument milk non silicone based medical lubricant prepared as described on the product label at room temperature in a suitable container and agitate for 15 seconds Figure 2 Figure 2 2 Drain Remove the attachment and allow it to drain until no visible droplets are coming from it Caution Do not rinse out instrument milk Do not apply mineral oil or other lubricants which may cause the attachment to overheat 46 DePuy Synthes Power Tools Anspach Pneumatic Systems User s Manual 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 Ensure equipment manufacturer s instructions are properly employed by trained and qualified personnel Ensure actual cycle employed has been properly validated for the device s load configuration being processed and appropriate sterilization indicator devices are included for each process and cycle Figure 1 Caution e Red protective cap for CSR60 and CSR60 BM must be removed prior to sterilization Figure 1 In the case m
63. y concentration Using cleaners disinfecting agents containing chlorinated phenols will result in premature hose failure Do not use hypochlorite i e bleach solutions since these will corrode metal components 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 1 Preparation Assemble 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 performance may occur 3 Inspect Visually inspect the handpiece and repeat step 2 until no visible soil remains Figure 1 Anspach Pneumatic Systems User s Manual DePuy Synthes Power Tools 31 Manual Cleaning 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 attachments e The process detergent and any additives must be discussed with detergen

pneumatIc systems

Contents

Download Pdf Manuals

Related Search

Related Contents