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EMAX 2 PLUS SYSTEM

1. Handpieces Handpiece Hose Two Foot Control Ports Two Handpiece Ports Console Features Console Irrigation pt tp cr T I z If two foot controls or two handpieces are connected Note The hose length shown above is shorter than upon startup of console it will default to Foot Control 1 the actual length for easier viewing Hose length 1S and or Handpiece 1 Port LED on console face panel does not illuminate when this accessory is connected to console approximately 12 feet e Power cord provides means to disconnect from the mains e Position equipment in such a manner that provides access to the rear of the system in order to disconnect from mains 12 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual eMax 2 Plus Operating Instructions System Assembly 1 Plug the hospital grade AC power cord into the AC power inlet on the back of the console Plug the opposite end of the power cord into a standard hospital grade grounded wall outlet Connect to supply mains with protective earth only 2 Insert foot control cord connector into Foot Control 1 connector port A second foot control cord may be connected into Foot Control 2 connector port on applicable consoles Foot control cord connector is keyed Align foot control cord connector with port on front of console Do not push foot control cord connector into console connector port when out of alignment 3 Plug
2. Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 1 1 lt 5 Ur 0 5 cycle 40 Ur 5 cycles 70 Ur 25 cycles lt 5 U for 5s lt 5 Ur 0 5 cycle 40 Ur 5 cycles 70 Mains power quality should be that of a typical commercial or hospital environment Note U is the a c mains voltage prior to application of the test level Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 7 Technical Specifications Table 3 Immunity not life supporting devices Guidance and manufacturer s declaration electromagnetic immunity The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below The customer or the user of the Anspach High Speed Electric System should assure that It is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment standard test level level guidance Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment should be used no closer to any part of the Anspach High Speed Electric IEC 61000 4 6 150 kHz to 80 MHz System including cables than the recommended separation distance calculated from the
3. Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 21 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 d st a a teo Note Instructions are written such that distal end of handpiece and attachment are pointed away from user 1 Ensure knurled knob on handpiece is in RUN m ORANGE 90 position R 2 Slide attachment over distal end of handpiece Push attachment towards handpiece and rotate attachment clockwise 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 counterclockwise and remove from distal end of handpiece 22 DePuy Synthes Power Tools Anspach eMax 2 Plus System
4. EN ANSPACH EMAX 2PLUS SYSTEM High spe ed performance and powef in a variety of applications 6 DePuy Synthes USER S MANUAL TABLE OF CONTENTS INTRODUCTION DePuy Synthes Power Tools 2 High Speed Electric Systems 2 Indications 3 Warnings and Cautions 4 Technical Specifications 5 Glossary of Symbols 10 OPERATING INSTRUCTIONS eMax 2 Plus 12 ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Standard Attachments and Dissection Tool Assembly 20 Minimal Access Attachment and 25 Dissection Tool Assembly microSaws and Small Attachments Assembly 27 Perforator Driver 30 CARE AND MAINTENANCE Inspection and Maintenance 31 Cleaning Instructions 35 Manual Cleaning 36 Manual Pre Cleaning Before Mechanical Automated Cleaning 40 Mechanical Automated Cleaning Following Manual Pre Cleaning 46 Lubrication 48 Sterilization 49 Loading Configuration 51 Troubleshooting 52 Ordering Information 53 Image intensifier control Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools ANSPACH ELECTRIC SYSTEMS HIGH SPEED PERFORMANCE AND POWER IN A VARIETY OF APPLICATIONS DePuy Synthes Power Tools DePuy Synthes Power Tools manufactures pneumatic and electric high speed performance instruments and attachments to meet the specific needs of both surgeon and staff While the advanced design of these instruments provides performance and reliability they also allow for effortless as
5. lt CONTAINS or PRESENCE of PHTHALATES Transmitter gt Interference may occur in the vicinity of equipment marked with this symbol K Type B Electrical Equipment sine Product warranty is void if seal is damaged oro Le or removed Y DO NOT DISPOSE OF IN HOUSEHOLD WASTE Instrument System Key eMax 2 Plus Latex free Certification Products not made with natural rubber latex Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools il EMAX 2 PLUS OPERATING INSTRUCTIONS The system console houses the electrical components that provide power control and cooling functions to the eMax 2 Plus handpiece It provides the user control for all system functions via an integral touch pad face panel The system console has connections for the eMax 2 Plus handpiece foot controls AC power inlet and the main power switch gt Power Switch Rear of Unit Face Panel The eMax 2 Plus High Speed Handpiece operates continuously at speeds up to 80 000 rpm Handpiece Connector Port Foot Control Connector Port Foot Control Hand Featues Controls Back of System Console azlar O O 3 lt 3 lt 49 MD 2 eF Da Un salsa AO AO eee ee IV Pole Mount Power Switch AC Power Inlet l Swivel 270 Attachment Connection Foot Controls Knurled Knob gt A pa Handpiece Hose Connector
6. 0 7 1 06bar Not applicable Patent Information For patent information go to www DePuy com patentmarking Additional Information To isolate the device from the mains supply remove the power cord All specifications are subject to change Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 5 Technical Specifications Table 1 Emission The Anspach eMax 2 Plus High Speed Electric System is composed of the eMax 2 Plus Handpiece model Electric Consoles models SC2100 SC2101 and SC2102 Foot Control models E FP E FP DIR E FP DIR IRR EPLUS FP EPLUS FP NS Hand Controls EMAX2 HC and E HC Guidance and manufacturer s declaration electromagnetic emissions The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below The customer or the user of the Anspach High Speed Electric System should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Anspach High Speed Electric System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely CISPR 11 to cause any interference in nearby electronic equipment RF emissions RF emissions Class A The Anspach High Speed Electric System is suitable for use in all establishments other than domestic establishments and those directly CISPR 1 connected to the public low voltage
7. Remove dissection tool from distal end of attachment Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 23 Standard Attachments and Dissection Tool Assembly QD Angle Attachments ope QD8 8 cm Quick Disconnect Angle Attachment QD11 11 cm Quick Disconnect Angle Attachment QD14 14 cm Quick Disconnect Angle Attachment QD11 Note Instructions are written such that distal end of handpiece and attachment are pointed away from user QD14 1 Move handpiece knurled knob to RUN m 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 attachm
8. location Symbol with yellow background CAUTION Refer to accompanying documentation AC Power Source CUTTER gt ia Indicates the drill tip exposure ADJUST TUBE 3mm gt Indicates the attachment setting refer to ine MA D20 and MA DRIVER section in this eee document for further details Consult Operating Instructions Indicates position or location Located on the Console this indicates Motor or Handpiece unit y Indicates position or location Located on the Console this indicates Foot Control activation SECURE RELEASE Indicates action of rotation and position for Secure LOCK and Release UNLOCK Located on the Console this indicates Hand Control activation lt lt Direction of rotation Direction of rotation for lock position Located on the Console this indicates Forward Clockwise rotation when looking at Handpiece from proximal end a a Direction of rotation Located on the Console this indicates Reverse Counterclockwise rotation when looking at Handpiece from proximal end Located on the Foot Pedal switch this indicates a change of rotational direction tor the Handpiece RPM Revolution per Minute N Located on the Foot Pedal switch this indicates a change state on off for the Console Irrigation System Located on the Console this indicates a change state on off for the Console Irrigation System Locat
9. 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 Saw Blade Removal 1 Saw blade removal is reverse of installation S SAW R SAW 28 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual microSaws and Small Attachments Assembly J Latch and Jacobs Chuck Small Attachments Assembly DRIVER Keyless Driver SA JLATCH Small Attachment J Latch SA JACOBS Small Attachment Jacobs Chuck Note DePuy Synthes Power Tools does not supply dissection tools for SA JLATCH or SA JACOBS small attachments Keyless driver refers to 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 Re
10. eMax 2 Plus Operating Instructions Console Indicators Code Description Audible Signal Corrective Action ey Pass System Fault None Turn Power switch to off and then back on If fault does not clear return console and handpiece to DePuy Synthes Power Tools for service E2 Handpiece Lock 10 slow beeps Rotate the knurled knob on handpiece clockwise to ensure the Engaged handpiece is not locked E3 Handpiece Stall 10 fast beeps Remove pressure from foot control or hand control Warning remove cutter from stalled location and restart handpiece EA ES Fault in Handpiece None Return console and handpiece to DePuy Synthes Power Tools for service E6 E7 Handpiece overheat 5 second beep Reduce or remove load trom handpiece to allow handpiece to warning impending cool If load is not reduced sufficiently handpiece will shut down handpiece shutdown 30 seconds after tone is heard and or code is displayed E9 Handpiece type None Disconnect connector and reconnect to console If fault does not not recognized clear return handpiece and console to DePuy Synthes Power Tools for service None Handpiece set 3 beeps to reverse Note Consoles with Software Version 3 0 and higher do not generate an Audible Signal for Codes E1 E9 Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 19 STANDARD ATTACHMENTS AND DISSECTION TOOL ASSEMBLY Straight Attachment Assembly Motor Housing Handpiece Kn
11. 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 tap water or drinking 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 Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 43 Manual Pre Cleaning Before Mechanical Automated Cleaning Attachments 3 Manipulate Moving Parts Manipulate all moving parts such as release sleeves under running cold tap water or drinking 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 and product 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 bristle brush to remove all visible soil Figure 7 Gently use ACB or SDCB wetted in cleaning solution to clean cannulations of attac
12. of items contaminated with body fluids with 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 No modification of this equipment is allowed To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth 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 Anspach 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 4 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual TECHNICAL SPECIFICATIONS eMax 2 Plus Handpiece Specifications Speed 10 000 80 000 rom Handpiece hose Length 3 81 m 12 5 ft Outside housing diameter 18 8 mm 74 in Length of housing 127 mm 5 i
13. 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 trom distal end of driver 26 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual MICROSAWS AND SMALL ATTACHMENTS ASSEMBLY The microSaws were designed for small bone dissection The microSaw Driver provides direct connection to all DePuy Synthes Power Tools electric handpiece systems The Driver also enables rapid exchange of saw head styles through a unique quick disconnect system DRIVER Keyless Driver Installation DRIVER Keyless Driver Note Instructions are written such that distal end of handpiece and attachment are pointed away from user Keyless Driver Installation 1 Ensure knurled knob on handpiece is in RUN m 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 eMax Keyless Driver Removal DRIVER 1 Move handpiece knurled knob to SAFE position 2 Rotate DRIVER counterclockwise and remove DRIVER Duty Cycle 30 Sec ON 30 Sec OFF for 8 cycles The recommendations for times of use for the DRIVER attachments have been determined under average load and worst case ambient air temperature of 85 F 29 C Anspach eMax 2 Plus System User s Manu
14. purposes only 30 DePuy Synthes Power Tools Anspach eMax 2 Plus System 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 Visually inspect for any damage to the tube e LONG e LONG S e LONG 01 e LONG HD e MEDIUM e MEDIUM HD e MIA16 e SHORT e SHORT HD e XL HD Visually inspect for bent or broken drive shaft and for any damage to the tube Angle Attachments e MA D20 e MA DRIVER e QD8 e QD8 S e QD11 e QD11 S e QD14 e QD14 S Visually inspect for bent or broken foot Craniotomes e CRANI A e CRANI A R e CRANI L CRANI A e CRANI P e CRANI 01 e CRAWNI L R Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 31 Inspection and Maintenance Other Attachments Visually inspect tor overall damage or missing components e ADG e CDA e CSR60 e DRIVER e ORANGE 45 e ORANGE 90 e O SAW e R SAW e S SAW e SA JACOBS e SA JLATCH Foot Controls e Visually inspect for damage electrical cord or connector e E FP e Visually inspect for damage or cracks to the housing e E FP DIR or pedal e E FP DIR IRR e EPLUS FP e EPLUS FP NS 32 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Inspection and Maintenance Hand Controls e Visually inspect for damage t
15. with ISO 17665 Before sterilizing Ensure sterilization equipment is in proper working order as specified by manufacturer Assure equipment manufacturer s instructions are properly employed by trained and qualified personnel Assure 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 Red protective cap for CSR60 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 Preparation Following mechanical cleaning and lubrication load the basket and sterilize in accordance with the following guidelines Figure 2 Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 49 Sterilization High Speed Handpieces and Attachments If using the EMAX2 TRAY Method Cycle Exposure Temperature Exposure Time Minimum Dry Time Steam Autoclave Pre vacuum Option 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 STERRAD 100S refer to the accompanying documentation of the individ
16. 2 cm Heavy Duty Extra Long Attachment Note Instructions are written such that distal end of handpiece and attachment are pointed away from user The arrows symbols and printing on the distal end of the handpiece housing RUN i LOAD gi and SAFE refer to locking and unlocking the attachment and dissection tool onto the handpiece 1 Move handpiece knurled knob to RUN A position 2 Slide attachment over distal end of handpiece Pull attach ment towards handpiece and rotate attachment to right approximately one quarter turn until fully seated Handpiece knurled knob moves up to seat next to attach ment 3 Pull handpiece knurled knob towards LOAD q position and insert dissection tool into distal end of attachment Rotate dissection tool slowly until fully seated 4 Release handpiece knurled knob into RUN i 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 Distal End Handpiece Knurled Knob Arrows and Symbols Handpiece eMax Straight Attachments SHORT MEDIUM LONG MIA16 SHORT HD MEDIUM HD LONG HD XL HD
17. ES a pe he mis d p een om a a Ji DiI fi PL rina Ee ee TILL D CELE Le 444 aaa See Ba TE IL LLCS r at it i E MAMA a TEC 10 AI Tae MEA AA T m TITIO ae HASTET E JEDAN TE TN e VETE e Ad Saag D MEDIUM HD way aiiis bu en bet eves Be Besar Si ia A A IR bn ea m tee lakolal age aL IL LS AAA JL Wea ves a ea a eee IITTI mep prr ara LL EL F pa lr q 11 4 h dy q i me a eee P CRANI A SHORT HD CRANI L Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools TROUBLESHOOTING EMAX 2 PLUS Problem Possible Cause Solution Excessive handpiece noise Faulty internal component Return to DePuy Synthes Power Tools for service Lack of power to console Plug is not fully inserted power switch not turned on Outlet is not functional Verity plugs to wall and back of console are pushed in completely and power switch is in I position Verify another piece of electrical equipment can receive power from outlet Handpiece vibration or extremely hot Faulty internal component Internal motor overheats due to continuous extreme cutting at near stalling conditions Hose may be kinked Handpiece out of balance Handpiece hose damaged Return to DePuy Synthes Power Tools tor service Console will shut handpiece off If it continues to shut off during
18. LUS FP NS Foot Control E FP Foot Control E FP DIR IRR Foot Control Directional Control Switch Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 15 eMax 2 Plus Operating Instructions Hand Control Assembly and Operation Optional hand control attachment for handpiece allows user to control operation with a lever attached to handpiece Warnings e Do not expose handpiece to magnets such as laying handpiece on magnetic drapes when in hand control mode as handpiece operation may occur e It is recommended that a craniotome not be used in conjunction with Hand Control Excessive rotational force on hand control may move it resulting in handpiece shutting down 1 Upon console start up Hand Control is OFF LED is not illuminated 2 Rotate handpiece until small dimple at proximal end hose end of handpiece faces up Slide hand control over distal end of handpiece such that notch on hand control slides over dimple at proximal end hose end of handpiece Slide Hand Control onto handpiece until secure 3 To activate Hand Control depress Hand button on console face panel This deactivates Foot Control Hand Control LED on face panel illuminates 4 To prevent inadvertent operation ensure silver lever on Hand Control is fully inserted in Lock position 5 Extend silver lever from Lock position for operation 6 Apply pr
19. Plus System User s Manual DePuy Synthes Power Tools 29 PERFORATOR DRIVER Perforator Driver CSR60 Perforator Driver with Hudson End This perforator driver attachment allows hudson style cranial perforators to be used with the eMax 2 Plus Systems 60 1 Ratio approximately 1 300 rom 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 1 Remove red storage cover 2 Move handpiece knurled knob to RUN position 3 Slide SoeedReducer over distal end of handpiece Pull SpeedReducer towards handpiece and rotate to right approximately one quarter turn until fully seated Handpiece knurled knob will move up to seat next to SpeedReducer 4 Pull SoeedReducer retaining sleeve towards handpiece Insert Hudson end of cranial perforator and release retaining sleeve Disassembly 1 Pull SoeedReducer retaining sleeve towards handpiece and remove cranial perforator from distal end of SpeedReducer 2 Move handpiece knurled knob to SAFE position 3 Rotate SoeedReducer 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
20. 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 Figure 12 6 Inspect Visually inspect the handpiece and repeat Steps 2 thru 6 until no visible soil remains Warning Manual pre cleaning must be followed by mechanical automated cleaning 42 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Manual Pre Cleaning 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 Sleeve in the EM XM Cleaning and Sterilization Basket Only indicated for the MA 10S MA 10C MA 15S MA 15C and MA 15ST 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
21. 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 D20 20 Angle Driver MA DRIVER Minimal Access Straight 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 O SAW Oscillating microSaw Attachment R SAW Reciprocating microSaw Attachment S SAW Sagittal microSaw Attachment SA JLATCH Small Attachment J Latch SA JACOBS Small Attachment Jacobs Chuck Warranty and Return Policy is available upon request Electric Instrument System EMAX2PLUS SC2101 SC2102 Err E FP DIR E FP DIR IRR E HC EMAX2 HC eMax 2 Plus Handpiece System Console with Irrigation System Console without Irrigation Electric Systems Foot Control Electric Systems Foot Control with Direction Electric Systems Foot Control with Direction a
22. User s Manual 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 CRANI L 7 5 cm Large Craniotome is CRANI A R 6 5 cm Rotating Adult Craniotome ADG edm Adjustable Drill Guide CRANI L CDA 6 8 cm Controlled Depth Attachment CRANI A R Warning It is recommended that a craniotome not be used in conjunction with Hand Control Excessive rotational force on hand control may move it resulting ADG in handpiece shutting down Note Instructions are written such that distal end of CDA handpiece and attachment are pointed away from user 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 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
23. Warning Transmissible Spongiform Encephakopathies 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 Transmissible Spongiform Encephalopathies Creutzfeldt Jakob Disease TSE CJD diagnosis DePuy Synthes Power Tools recommends that all DePuy Synthes Power Tools products used on a patient confirmed with a TSE CJD diagnosis be incinerated DePuy Synthes Power Tools dissecting tools used on a patient suspected of TSE CJD diagnosis must be incinerated Note At the point of use the equipment should be wiped of any gross soil and transferred to the cleaning and sterilization area for immediate processing 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 eMax 2 Plus System User s Manual DePuy Synthes Power Tools 35 MANUAL CLEANING HIGH SPEED HANDPIECES Detergents e Neutral PH enzymatic detergents are recommended tor 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 dete
24. al DePuy Synthes Power Tools 27 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 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 and saw attachment will be in alignment 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 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 Assembly 1 Rotate chuck counterclockwise until chuck has opened sufficiently to accept a saw blade
25. ch 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 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 Portable and Mobile RF communications equipment can affect Medical Electrical Equipment Use of accessories or cable other than those provided by DePuy Synthes Power Tools and specified for the electric system in use may result in increased emissions or decreased immunity Do not use in oxygen rich environment Do not modify Modifications could result is loss of electrical safety Dispose
26. chments 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 detergent 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 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 CSR6O0 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 non chlorinated detergent prepared as described on the product label at room temperature in a suitable container and agitate for 15 seconds Figure 3 Note DO NOT IMMERSE as marked on attachments is for OR
27. e 2 minutes Cold tap water or drinking water Pre wash 1 minutes Warm water gt 40 C use detergent Cleaning 2 minutes Warm water gt 45 C use detergent Rinse 5 minutes Rinse with deionized DI or purified water PURW Thermal Processing 5 minutes Hot DI water gt 93 C Dry 40 minutes 2 90 Caution Do not use neutralizing agent 3 Inspect Visually inspect the devices and repeat the manual pre clean and mechanical automated clean until no visible soil remains Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 47 LUBRICATION HANDPIECES 1 Do not lubricate the handpiece 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 48 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual STERILIZATION HIGH SPEED HANDPIECES AND ATTACHMENTS The following sterilization instruction has been validated by DePuy Synthes Power Tools in accordance
28. 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 46 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Mechanical Automated Cleaning Following Manual Pre Cleaning High Speed Handpieces and Attachments 1 Loading the Basket EX BSKT BTM EM XM Cleaning and Sterilization Basket Bottom EX BSKT INS EM XM Cleaning and Sterilization Basket Insert EX BSKT LID EM XM Cleaning and Sterilization Basket Lid Load the devices in the basket by securing them in the Figure 1 Figure 2 appropriate brackets as marked on the basket Figure 1 Reference loading configuration pictures on Page 51 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 Note Before putting on seal cap turn black cap to wrap cable tight around it Figure 3 Figure 3 Figure 4 Caution Connector ends of electric and pneumatic handpieces must be sealed with special seal caps provided Figure 4 2 Mechanical Automated Cleaning Cycle Process Parameters Cycle Duration minimum Cleaning Instructions Rins
29. ed on the Console this indicates a change of irrigation rate for the Console Irrigation System 10 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Glossary of Symbols Located on the Console this indicates a change of rotational speed rate for the Handpiece Keep Dry A K A Protect from Moisture Temperature Limits Sterile unless damaged or open 03 Equipotential post location United States Federal law restricts this device Font to sale by or on the order of a physician or other licensed health care provider Found on the Console ON OFF Located on the Console Irrigation Pump this indicates a possible finger pinch point CE Mark A K A CE Mark notified body number Conformit Europ enne E Meaning Device complies with applicable EEC Directives Located on the Console Irrigation Pump these symbols are not Tube diameter o used by the user since the pump is self adjusting to the Irrigation E Lock Run Bo Unlock Load Reference Number A K A Item Number Catalog Number Part Number Lot A K A Lot Number Batch Number Batch Code Serial Number 00 0000 E Use By Date A K A Expiration Date Expiry Manufacturer Authorized European Union Representative Sterilized Using Irradiation Single Use Only A K A Do Not Reuse CAUTION Refer to accompanying documentation DEHP
30. ed water and agitate for 15 seconds 5 Inspect Repeat Steps 2 4 until there is no evidence of soils or residuals on the attachment surface or ACB 38 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Manual Cleaning ELECTRIC CONSOLES FOOT CONTROLS AND TRAYS Electric Console and Foot Control Caution Do not immerse or sterilize Do not allow liquid to enter the console or foot control 1 Clean Disconnect all power from console Clean console and foot control by wiping with nonabrasive cloth and disinfectant or mild detergent and deionized distilled or purified water after each case 2 Dry Dry thoroughly with non abrasive cloth Trays Trays can be cleaned with deionized distilled or purified water and a mild detergent pH neutral Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 39 MANUAL PRE CLEANING 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 cause device to malfunction Please note use of alkaline detergents can cause color t
31. ent to left approximately one quarter turn and remove from distal end of handpiece UW 24 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual MINIMAL ACCESS ATTACHMENT AND DISSECTION TOOL ASSEMBLY Note Instructions are the same for straight or angled drivers and for straight or curved bearing sleeves in both 10 cm 15 cm and 19 cm lengths The four words MADAN labeled on the drivers mean the following CUTTER Insert or remove dissection tool RUN Attachment and dissection tool are a keai MA DRIVER now functional ADJUST Bearing Sleeve can be moved 3 mm forward or back TUBE Insert or remove bearing sleeve Warning The Minimal Access Attachments are to be used only for 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 Driver Installation MA D20 20 Angle Driver MA DRIVER Minimal Access Straight Driver Note Instructions are written such that distal end of handpiece and attachment are pointed away from user 1 Ensure handpiece knurled knob is in Run m position 2 Insert drive shaft 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 Anspac
32. equation applicable to the Radiated RF 3 V m 3 V m frequency of the transmitter IEC 61000 4 3 80 MHz to 2 5 GHz Recommended separation distance d 1 2 4P d 1 2 4P 80 MHz to 800 MHz d 2 3 4P 800 MHz to 2 7 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol tm Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Anspach High Speed Electric System is used exceeds the applicable RF compliance level above the Anspach High Speed Electric System or the device which conta
33. essure on Hand Control to operate handpiece Note Handpiece is fully functional at this time 7 To deactivate Hand Control depress Foot button on console face panel To remove hand control from handpiece slide towards distal end of handpiece and remove Dimple Notch lines up with Dimple eMax 2 HC 16 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual eMax 2 Plus Operating Instructions Optional Irrigation Assembly and Operation Excludes SC2102 1 Upon start up Irrigation is OFF LED is not illuminated 2 Depress the button located on the right side of the console to eject pump head 3 Insert IV pole into bracket on back of console Hang irrigation bag onto IV Pole 5 To activate depress the Irrigation button on the face panel LED illuminates 6 To control flow of irrigation depress arrows located to right of irrigation button on face panel 7 Irrigation can also be activated from certain optional Foot Controls see Step 5 of Foot Control Operation Depress Irrigation Control Switch on top right of the foot control Upon activation LED on face panel illuminates ES Irrigation Tubing Set up IRRIGATE TUBE Sterile Tubing and Hoseclips for Irrigation System Sterile High Flow Tubing and Hoseclips for Irrigation System IRRIGATE TUBE HF Warning These products may contain DEHP a type of phthalate DO NOT use product on children or pregnant or nu
34. f handpiece depress blue arrows located on console face panel Speed increases and decreases in 10 000 RPM increments Each LED will indicate the max RPM 10 10 000 RPM 20 20 000 RPM 30 30 000 RPM 40 40 000 RPM 50 50 000 RPM 60 60 000 RPM 70 70 000 RPM 80 80 000 RPM 2 To change direction depress R or F arrow located on console face panel Console beeps once indicating handpiece direction has changed Direction can only be changed when handpiece is not running A series of three beeps indicates console is set to operate handpiece in reverse counterclockwise direction LED on console face panel located to left of F indicates forward direction LED located to left of R indicates reverse direction 3 Optional To activate irrigation depress Irrigation button on face panel LED illuminates To control flow of irrigation depress arrows located to right of irrigation button on face panel Increase Speed Decrease Speed LED Forward F Forward R Reverse Hand Control LED Foot Control 1 LS LED Foot Control 2 Foot Control Irrigation ON OFF Irrigation Increase Decrease Note Depressing simultaneously the Irrigation Increase and Decrease buttons will display the Console Software version as a two digit number For example XY this to be interpreted as Software Version X Y On Consoles with no Irrigation SC2102 t
35. h eMax 2 Plus System User s Manual DePuy Synthes Power Tools 25 Minimal Access Attachment and Dissection Tool Assembly Bearing Sleeve and Dissection Tool Assembly 20 Angle Driver or Straight Driver MA 10S 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 tip 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 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
36. handpiece hose connector into Handpiece 1 connector port located on front of console A second handpiece could be connected into Handpiece 2 connector port on applicable consoles Handpiece hose connector is keyed Align handpiece hose connector with connector port on front of console Do not push handpiece hose connector into console connector port when out of alignment 4 Activate console by depressing power switch located on the back of the console to the position Appropriate Face Panel Light Emitting Diodes LED illuminate and a beep sounds 5 For operating instructions see Console Face Panel Operation and Foot Control Operation below Note Handpiece is fully functional at this time Warning Before first use clean and sterilize as indicated Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 13 eMax 2 Plus Operating Instructions Operating Instructions Upon startup console is set to operate handpiece in forward clockwise when viewed from the proximal end of the Handpiece direction at maximum speed and display reads 80 000 RPM System operation including optional irrigation can be controlled trom console face panel On applicable consoles LED s on face panel correspond to connector ports on connector panel System operation can also be controlled by several available foot control options and an optional hand control Console Face Panel Operation 1 To increase or decrease speed o
37. he buttons are not marked but are located in the same location which are detectable by feel 14 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual eMax 2 Plus Operating Instructions Foot Control Operation Certain optional foot controls have direction and irrigation control switches 1 See Step 2 of Console Face Panel Operation to set operational direction of handpiece 2 Optional Depress Foot button on face panel to activate Foot Control 1 depress again to activate Foot Control 2 Only one foot control may be active at a time Note Handpiece is fully functional at this time 3 Press on foot control pedal to start handpiece Increase pressure on pedal to increase speed of handpiece and release pressure on pedal to decrease speed of handpiece 4 Optional To change direction of handpiece depress Directional Control Switch located on top left of foot control for a minimum of one second When direction changes a single beep will sound and LED on console face panel indicates direction of rotation Direction can only be changed when handpiece is not running 5 Optional To activate irrigation depress Irrigation Control Switch on top right of foot control for a minimum of one second and then step on center of foot control pedal Upon activation LED on face panel illuminates irrigation pump and handpiece start Directional Control Switch 7 Irrigation Control 3 Switch EPLUS FP or EP
38. hment The brushes may be inserted trom 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 with MA D20 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 SDCB may be inserted from distal or proximal end of bearing sleeve 44 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Manual Pre Cleaning Before Mechanical Automated Cleaning Attachments 4 Rinse Thoroughly Rinse the attachment thoroughly under running hot tap water or drinking water for a minimum of two 2 minutes Figure 8 Use a syringe or pipette filled with hot tap water or drinking 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 thru 6 until no visible soil remains Warning Manual pre cleaning must be followed by mechanical automated cleaning Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 45 MECHANICAL AUTOMATED CLEANING FOLLOWING MANUAL PRE CLEANING HIGH SPEED HANDPIECES AND ATTACHMENTS Dete
39. horoughly under running cold tap water or drinking 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 Figure 6 Figure 7 Figure 8 Figure 9 Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 41 Manual Pre Cleaning Before Mechanical Automated Cleaning High Speed Handpieces 9 Rinse Thoroughly Rinse the handpiece thoroughly under running hot tap water or drinking water for a minimum of two 2 minutes Figure 10 Place locking mechanism in SAFE position prior to 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 tap Figure 10 Figure 11 water or drinking water Figure 12 Place the knurled knob in the
40. ins it should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device containing the Anspach High Speed Electric System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 8 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Technical Specifications Table 4 Recommended separation distances not life supporting devices Recommended separation distances between portable and mobile RF communications equipment and the Anspach High Speed Electric System The Anspach High Speed Electric System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Anspach High Speed Electric System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Anspach High Speed Electric System as recommended below according to the maximum output power of the communication equipment Rated maximum output Separation distance according to frequency of transmitter power oh SEED 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W d 4 24P d 1 2 VP d 2 34P 0 01 12 cm 12 cm 23 cm 0 1 38 cm 38 cm 73 cm 1 1 2m Zio 2 3 M 10 3 8 m 3 8 Mm Zam 100 12 m 12 m 23 m For transmitters rated at a maxim
41. lease 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 Y 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 until it touches bottom 3 Rotate knurled knob counterclockwise while centering dissection tool 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 with other hand counterclockwise until attachment is released Anspach eMax 2
42. lete 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 9 DePuySynthes 2 2 c 4 POWER TOOLS COMPANIES OF fohmonsfohwon ul mes 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 infoPowerlools DPYUS jnj com www depuysynthes com DePuy Synthes Power Tools a division of DOI 2013 All rights reserved J12178 A 9 13 19 0019 A
43. n Handpiece weight 104 g 3 7 oz Handpiece Hose Weight 0 59 kg 1 29 lbs Console SC2000 SC2100 SC2101 SC2102 Specifications Electrical Primary 100 240VAC 50 60 Hz 250 VA Class Protective Earth Fluid Ingress Protection IPXO Type B Applied Part Continuous Operation Mechanical Size 311150 14 6 cm X 32 7 cm 12 25 In x 5 74 In X 12 87 in Weight 6 25 kg 13 77 lbs The device complies with the following standards IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 EN 60601 1 2006 A11 2011 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 08 3rd Edition Medical elec trical part 1 General requirements for basic safety and es sential performance ETL CLASSIFIED Intertek With regard to electrical shock fire mechanical hazards this ETL classified device conforms to AAMI STD ES60601 1 and is certified to CSA STD C22 2 No 60601 1 This device complies with applicable EEC directives CE Foot Pedal E FP E FP DIR E FP DIR IRR Specifications Size 26 7 cm x 16 5 cm x 14 7 cm 10 5 in x 6 5 in x 8 5 in Weight 2 0 kg 4 41 Ibs Cord 3 66 m 12 ft in length Fluid Ingress Protection IPXS Environmental Conditions Temperature Operating Transportation and Storage 18 30 C 65 85 F 40 70 C 40 158 F Relative Humidity Operating Transportation and Storage 30 70 10 95 Atmospheric Pressure Operating Transportation and Storage 70 106 kpa
44. nation 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 50 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual LOADING CONFIGURATION HIGH SPEED HANDPIECES AND ATTACHMENTS Seal Cap when not in use EX BSKT BTM CSR60 F e ditis RA EX BSKT INS SHORT TIR Ei vail Vien il reer y EEE EE E ECM k MA Bearing Sleeves excluding MA19 ST MEDIUM es Jani Ar RRERRARO Seal cap installed on connector end of handpiece LONG E lalate titatita tit Yra Pan papa paya AA PA a AA HETE E AA a dE AMENA aa Mi revere relay MA D20 T S68 1 a 88 Fii E yy i EESE E if Sean JL TEC i e E TELLIT 22282888 EA E Ann A TELEL L aa eeeee ana ea IDO Hea 0 E EET Ti Lio yy tf TELI MO AAA E F p g E E E E i EE A a EMAX2PLUS or XMAX MIA16 LONG H EIE VER E Al Mid A LES 1959 58 000 00910 DD E PE ek ttt ol AS ENEE Sd 0 0 008 0 00 0 A AAA eee Ll dl EA A oe EPA 008 0801080 080620 00 OS IN E 1 Cl TEL Bm br Leal calido ee Line hp TP fh Lote PE ee ee roe PP EEE EY i S2eeee8e0 y AA QD8 QD11 CRAN LA P
45. nd Irrigation Hand Control Hand Control Electric Instrument System Accessories EMAX2 TRAY 05 001 100 EX BSKT EX BSKT BTM EX BSKT INS EX BSKT LID Sterilization Case and Tray Cart EM XM Cleaning and Sterilization Basket Set EM XM Cleaning and Sterilization Basket Bottom EM XM Cleaning and Sterilization Basket Insert EM XM Cleaning and Sterilization Basket Lid Irrigation System IRRIGATE TUBE Sterile Tubing and Hoseclips for Irrigation System IRRIGATE TUBE HF Sterile High Flow Tubing and Hoseclips for IRR CLIP 10 IRR CLIP 20 IRR CLIP 30 IRR CLIP 40 IRR CLIP 50 IRR CLIP 60 Irrigation System 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 Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 53 EN ANSPACH Limited Warranty and Disclaimer The Anspach Effort Inc products are sold with a limited warranty 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 comp
46. normal cutting return to DePuy Synthes Power Tools for service Unkink hose verify it is not being pinched or clamped to table Return to DePuy Synthes Power Tools for service Return to DePuy Synthes Power Tools for service Excessive vibration of cutting burr Cutting burr may be bent Cutting burr may not be fully seated Improper attachment and cutting burr combination Possible attachment bearing damage Replace with new eMax 2 Plus cutting burr Reassemble cutting burr and attachment Only use correct cutting burr with appropriate attachment Return attachment to DePuy Synthes Power Tools for service Attachment is hot Debris lodged inside attachment Possible bearing damage Clean attachment using DePuy Synthes Power Tools Attachment Cleaning Instructions located in this manual Return attachment to DePuy Synthes Power Tools for service Craniotome attachment is bent Excessive force used in operation Do not use replace attachment Inoperative Foot Control LEDs are illuminated on face panel Selected foot control on face panel does not match foot control in use System is set in hand control mode LED light is illuminated Plugs may not be Tully inserted Handpiece is in Sate position or cutter is not rotating Defective attachment Press Foot Control button on face panel to select other Foot Control Press Foot Control button on face panel to set it for Foot Contr
47. o fade but this does not impair function of device 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 Electric systems only Place the attached cap onto the console connector end of the handpiece Figure 2 Figure 1 Figure 2 2 Rinse Rinse the handpiece with distal end pointing down under running cold tap water or drinking 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 Figure 3 Figure 4 Distal End 40 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Manual Pre Cleaning Before Mechanical Automated Cleaning High Speed Handpieces 3 Manipulate Moving Parts Manipulate the handpiece knurled knob under running cold tap water or drinking 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 and product concentration dilution Spray and wipe the handpiece with the cleaning solution for a minimum of two 2 minutes Rinse the handpiece t
48. o the levers e E HC e Visually inspect for presence of magnet on the e EMAX2 HC lever mechanism Magnet EMAX2 HC Handpiece Ensure that the knurl knob operates properly e EMAX2PLUS e If the knob is hard to turn it may be lubricated Please refer to the instructions for use e Visually inspect for damage to the silicone hose or to the electrical connector e Connect to console and operate The handpiece should operate smoothly e There is no requirement to operate with attachment or dissection tool Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 33 Inspection and Maintenance Consoles e Visually inspect for damage or cracks to the housing e SC2100 e Visually inspect for damage to the electrical power cord e SC2101 e SC2102 e Power the system and inspect for illumination of the LEDs e If there is an irrigation pump present check for proper function If the irrigation flow LED display is not on press the Drop button E F ATEN g oD Te a j i q 34 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual CLEANING INSTRUCTIONS ELECTRIC HIGH SPEED SYSTEMS The following manual cleaning and mechanical automated cleaning with manual pre cleaning instructions have been validated by DePuy Synthes Power Tools for preparing a nonsterile medical device this instruction is provided in accordance with ISO 17664 2004 and ANSI AAMI ST81 2004
49. ol 1 or 2 depending which one is in use Verify plugs for handpiece and foot control are fully inserted Plug will latch in place once fully inserted Verify cutting burr is completely engaged and handpiece s knurled knob is in secure position Clean attachment or replace attachment Inoperative Hand Control Defective internal component Hand Control Attachment may not be Tully installed Selected Hand Control on face panel is not in use Internal handpiece switch activating Hand Control may be damaged Return to DePuy Synthes Power Tools for service The circumferential groove on handpiece housing will be exposed when the Hand Control is fully installed Press Hand Control button on face panel to illuminate Hand Control LED Return to DePuy Synthes Power Tools for service 52 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual ORDERING INFORMATION Anspach 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
50. ooth part of the connector as the connector will not disengage trom the console Cautions e Do not sterilize and do not allow liquid into pump e Do not operate with pump head open Warnings Irrigation tubing attachment clip and hose clip are for SINGLE USE ONLY Avoid stacking or placing the eMax 2 Plus System consoles near other electrical equipment Ifthe eMax 2 Plus System consoles must be stacked or used adjacent to other electrical equipment it should be observed to verify normal operation prior to use The eMax 2 Plus System is Medical Electrical Equipment requiring special precautions related to EMC and for this reason must be put into service as described in this product manual Firm control of the eMax 2 Plus must be maintained at all times Never force the dissection tool Let the instrument do the cutting Only Anspach cutting burrs should be used with the eMax 2 Plus Always use continuous irrigation to prevent heat build up Never use the attachments as a retractor to bend or pry Power source should comply with applicable IEC CEC and NEC requirements Grounding reliability can only be achieved when this equipment is connected to a receptacle marked HOSPITAL GRADE Note If fuse replacement is necessary use only Time Delay fuse rated 2 5A 250V Item to be replaced by a DePuy Synthes Power Tools repair facility ONLY 18 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual
51. personnel only Please refer to cleaning instructions provided with the MA attachments for Minimal Access MA Attachments Minimal Access Drivers MA D20 MA DRIVER Minimal Access Bearing Sleeves MA 10S MA 10C MA 15S MA 15C MA 15ST amp MA 19ST Figure 1 Figure 2 Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 37 Manual Cleaning Attachments 3 Clean Cannulations Caution This step refers ONLY to the following attachments for other attachment proceed to step 4 Type of Attachment Names of Attachments Straight Attachments SHORT MEDIUM LONG MIA16 SHORT HD MEDIUM HD LONG HD XL HD LONG S LONG 01 Craniotomes CRANI A CRANI A R CRANI A 01 CRANI P CRANI L CRANI L R Specialty Attachments ADG CDA QD Attachments QD8 QD8 S QD11 QD11 S QD14 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 though the attachment Do not use ACB with MA D20 and MA DRIVER ACB is to be utilized once per system set and discarded once the system cleaning is complete Figure 4 4 Rinse Rinse the attachment in a suitable container filled with deionized distilled or purifi
52. power supply network that supplies TETT a ER Class A buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 6 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Technical Specifications Table 2 Immunity all devices Guidance and manufacturer s declaration electromagnetic immunity The Anspach High Speed Electric System is intended for use in the electromagnetic environment specified below The customer or the user of the Anspach High Speed Electric System should assure that it is used in such an environment Immunity test standardU 25 cycles IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the IEC 61000 4 2 8 kV air 8 kV air relative humidity should be at least 30 Electrical fast 2 kV for 2 kV for Mains power quality should be that of a typical transient burst power supply lines power supply lines commercial or hospital environment 1 kV for 1 kV for IEC 61000 4 4 input output lines input output lines Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line 2 kV line to earth Mains power quality should be that of a typical commercial or hospital environment
53. rgent manufacturer Warning Wear eye protection and any additional PPE required 1 Preparation Assemble all necessary supplies such as a lint free cloth Remove the attachment and dissection tool from the handpiece Figure 1 Place the attached cap onto the console connector end of the handpiece Figure 2 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 Cautions 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 any concentration Using cleaners disinfecting agents containing chlorinated phenols will result in premature hose failure e 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 Figure 1 Figure 2 36 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Manual Cleaning ATTACHMENTS Caution Manual Cleaning Instructions for all Atta
54. rgents 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 Only indicated for the MA 10S MA 10C MA 15S MA 15C and MA 15ST Mechanical Automated Cleaning Guidelines DePuy Synthes Power Tools can only be mechanically cleaned under the following conditions e Cannulations must be pre cleaned with appropriate brushes as described in pre cleaning 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 demineralized deionized water must be used during final rinse to prevent corrosion and spots
55. rsing mothers 1 Lift top of pump head and insert large diameter tubing Refer to diagram on irrigation pump housing to ensure tubing is routed properly smaller diameter tubing flows towards the Anspach handpiece housing 2 Close lid on pump head 3 Insert bayonet end of tubing into irrigation bag Caution Tubing can disconnect from connectors without warning if occluded DO NOT step on set equipment on pinch kink clamp or otherwise occlude tubing during use Irrigation Attachment Clip Assembly Refer to Components section for part numbers 1 Slide irrigation tubing onto proximal end of irrigation attachment clip 2 Attach irrigation attachment clip to handpiece 3 Secure tubing to handpiece hose using Hoseclips which are included with tubing Irrigation Pump Irrigation Pump Release Button gt Increase Flow LED Irrigation lt lt Decrease Flow Flow Rate Irrigation Activate and Deactivate Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 17 eMax 2 Plus Operating Instructions System Shutdown There are no special procedures for system shutdown To disconnect power cord from mains grasp ridged portion of connector between thumb and forefinger of one hand Gently pull the connector away from the console The connector should remove easily If not ensure only the ridged portion of the connector is pulled Do not pull on the sm
56. sembly meeting the needs of both surgeon and staff 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 Electric 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 either at DePuy Synthes Power Tools or from 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 eMax 2 Plus High Speed Electric Systems The eMax 2 Plus operates up to 80 000 rpm It offers variable speed bi directional operation minimal noise levels and an optional hand control It is a high performance system that highlights minimal vibration performance thermal energy management and high reliability for Neurosurgeons Otologist Neurotologists Skull Base Surgeons and Spinal Surgeons Y a Neurosurgery and Otologic surgery Spine surgery 2 DePuy Synthes Po
57. ual 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 Foot Controls consoles and irrigation pumps should not be sterilized It is required to include the drying cycle to avoid possible adverse effects caused by exposure to condensation 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 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 processes and wrapping techniques employed brand model and condition of sterilization equipment care and maintenance techniques employed and operator knowledge and experience e DePuy Synthes Power Tools cannot anticipate all possible equipment processes and or conditions that may be encountered The suggested operation conditions are to be considered as a starting point for determi
58. um output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 9 GLOSSARY OF SYMBOLS Located on the Foot Pedal switch this indicates a change state on off for the Console Irrigation System 30 Sec ON Duty Cycle of the e12 system and DRIVER 30 Sec OFF X Company Logo Direction of rotation A Direction of rotation for lock position Located on the Foot Pedal switch this indicates a change of rotational direction for the Handpiece lt Indicates setting position or location gt Indicates setting position or location Located on the Handpiece this indicates position of the knurl knob to the desired
59. urled Straight Attachment Ey ANSPACH m T i Craniotome Attachment Assembly EEES DO O o Motor Housing Handpiece Knurled Dissection Tool Knob Dissection Tool _ _ CMI Craniotome Attachment EN ANSPACH l G a 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 An example follows Dissection Tool Part Number S 2B Dissection Tool Description 2 mm Fluted Ball for Short attachment Note Each attachment is laser marked with its corresponding part number gt gt ol D o 20 DePuy Synthes Power Tools Anspach eMax 2 Plus System User s Manual Standard Attachments and Dissection Tool Assembly 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
60. wer Tools Anspach eMax 2 Plus System User s Manual INDICATIONS The Anspach eMax 2 Plus High Speed Electric System is intended for cutting and shaping bone including spine and cranium The Anspach eMax 2 Plus High Speed Electric System is composed of the EMAX2PLUS Handpiece model Electric Consoles models SC2100 SC2101 and SC2102 Foot Control models E FP E FP DIR E FP DIR IRR EPLUS FP EPLUS FP NS Hand Controls EMAX2 HC and E HC Anspach eMax 2 Plus System User s Manual DePuy Synthes Power Tools 3 WARNINGS AND CAUTIONS Warnings MA 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 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 whi

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