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Synthes Anspach Instructions For Use Manual Download Page 4

Indications

                                                                                                                             Anspach Electric Systems

Instructions for Use

      Synthes

           3

The Synthes Anspach High Speed
 Electric Systems are intended for
 cutting and shaping bone including
spine and  cranium.

The Synthes Anspach High Speed
 Electric System is composed of Hand-
piece models eMax2, eMax2 Plus, E12,
and E-Saggital; Electric Consoles
 models SC2000, SC2000U, SC2100,
SC2101, and SC2102; Foot Control
models E-FP, E-FP-DIR, E-FP-DIR/IRR,
EPLUS-FP, EPLUS-FP-NS, EMAX2-FP,
EMAX2-FP-NS; Hand Controls 
EMAX2-HC, E-HC and E12-HC.

Neurosurgery and ENT

Spine surgery

0x6.001.507_AD  13.06.14  11:11  Seite 3

Summary of Contents for Anspach

Page 1: ...High Speed Power Tools Anspach Electric Systems High speed performance and power in a variety of applications Instructions for Use ...

Page 2: ...fications 5 Glossary of Symbols 10 eMax 2 and eMax 2 Plus 12 e12 Small Bone System 20 Standard Attachments and Dissection Tool Assembly 21 Minimal Access Attachment and Dissection Tool Assembly 27 Micro Curved Attachment MCA and 29 Curved Burr Support Sleeves Curved Burr microSaws and Small Attachments Assembly 30 Sagittal Saw 33 Compact SpeedReducer 34 Inspection and Maintenance 35 Manual Cleanin...

Page 3: ...this manual please contact your local Sales Representative High Speed Electric Systems The eMax 2 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 Neurotologists Skull Base Surgeon...

Page 4: ...ing spine and cranium The Synthes Anspach High Speed Electric System is composed of Hand piece models eMax2 eMax2 Plus E12 and E Saggital Electric Consoles models SC2000 SC2000U SC2100 SC2101 and SC2102 Foot Control models E FP E FP DIR E FP DIR IRR EPLUS FP EPLUS FP NS EMAX2 FP EMAX2 FP NS Hand Controls EMAX2 HC E HC and E12 HC Neurosurgery and ENT Spine surgery ...

Page 5: ... single patient use only Do not re sterilize and or re use 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 af fe...

Page 6: ...N CSA C22 2 No 601 1 This device complies with applicable EEC directives Foot Pedal E FP E FP DIR E FP DIR IRR Specifications Size 26 7 cm216 5 cm214 7 cm 10 5 in26 5 in28 5 in Weight 2 0 kg 4 41 lbs Cord 3 66 m 12 ft in length Fluid Ingress Protection IPX8 Environmental Conditions Temperature Operating 18 30 C 65 85 F Transportation and Storage 40 70 C 40 158 F Relative Humidity Operating 30 70 T...

Page 7: ...or the user of the Synthes Anspach High Speed Electric System should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Synthes Anspach High Speed Electric System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby elect...

Page 8: ... 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment 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 Voltage dips shor...

Page 9: ...rmined by an electromagnetic site survey a should be less than the com pliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 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 ...

Page 10: ...distance according to frequency of transmitter 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 12 cm 12 cm 23 cm 0 1 38 cm 38 cm 73 cm 1 1 2 m 1 2 m 2 3 m 10 3 8 m 3 8 m 7 3 m 100 12 m 12 m 23 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the...

Page 11: ...e Counterclockwise rotation when looking at Handpiece from proximal end Revolution per Minute Located on the Console this indicates a change state on off for the Console Irrigation System Located on the Console this indicates a change of irrigation rate for the Console Irrigation System 30 Sec ON Duty Cycle of the e12 system and DRIVER 30 Sec OFF Company Logo Direction of rotation Direction of rot...

Page 12: ...pean Union Representative Sterilized Using Irradiation Single Use Only 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 Conformité Européenne Mean...

Page 13: ...ax 2 and eMax 2 Plus handpieces 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 and eMax 2 Plus handpieces foot controls AC power inlet and the main power switch The eMax 2 and eMax 2 Plus High Speed Handpieces oper ate continuously at speeds up to 80 000 rpm Power Switch Handpiece Connector Port Foot Cont...

Page 14: ... tor port when out of alignment 3 Plug handpiece hose connector into Handpiece 1 connec tor 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 ...

Page 15: ... 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 of 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...

Page 16: ...trol pedal to start handpiece Increase pressure on pedal to increase speed of handpiece and re lease pressure on pedal to decrease speed of handpiece 4 Optional To change direction of handpiece depress Direc tional 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 in dicates direction of rota...

Page 17: ...l 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...

Page 18: ... face panel illuminates Irrigation Tubing Set up IRRIGATE TUBE Sterile Tubing and Hoseclips for Irrigation System IRRIGATE TUBE HF Sterile High Flow Tubing and Hoseclips for Irrigation System 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 Synthes Anspach handpiece housing...

Page 19: ...quipment If the eMax 2 or 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 and eMax 2 Plus Systems are Medical Electri cal Equipment requiring special precautions related to EMC and for this reason must be put into service as de scribed in this product manual Firm control of the eMax ...

Page 20: ...ult in Handpiece None Return console and handpiece to Synthes Anspach for service E6 E7 Handpiece overheat 5 second beep Reduce or remove load from 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 ...

Page 21: ...ged contours on e12 handpiece body release ring and small attachment will align For specific attachment assembly refer to microSaws and Small Bone Attachments Assembly section in this manual Optional e12 Hand Control Assembly and Operation Optional Hand Control attachment for e12 handpiece allows user to control operation of handpiece with a lever attached to e12 1 To attach Hand Control hold hand...

Page 22: ...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 Each attachment is laser marked with its corresponding part number Straight Attachment Assembly Craniotome Attachment Assembly Motor Housing Handpiece Knurled Knob Knurled Knob Dissection Too...

Page 23: ...locking the attachment and dissection tool onto the handpiece 1 Move handpiece knurled knob to RUN 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 attach ment 3 Pull handpiece knurled knob towards LOAD posi tion and insert disse...

Page 24: ... up with your thumb 4 Insert dissection tool into the side of the distal end oppo site 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...

Page 25: ...and insert dissection tool into distal end of hand piece 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 attach ment towards handpiece and rotate attachment to right approximately one qu...

Page 26: ...ngle attachment towards hand piece and rotate to left to the RELEASE position 4 Insert dissection tool into angle attachment Rotate dis section 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 dissec...

Page 27: ...approximately one quarter turn until fully seated Hand piece knurled knob moves up to seat next to attachment 5 Attachment and dissection tool are secure Note Handpiece is now fully functional Disassembly 1 Move handpiece knurled knob to SAFE position 2 Slowly rotate dissection tool in alternating directions while removing distally 3 Rotate attachment to left approximately one quarter turn and rem...

Page 28: ...e 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 hand piece and attachment are pointed away from user eMax Driver Installation 1 Ensure handpiece knurled knob is in RUN position 2 Insert drive shaft of driver into...

Page 29: ... 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 t...

Page 30: ...CA Assembly MCA Micro Curved Attachment 1 Ensure handpiece knurled knob is in RUN position 2 Insert MCA s drive shaft into distal end of handpiece push and rotate to right until it stops Listen for a click as hand piece knurled knob moves up to seat next to MCA 3 Gently twist back and forth to ensure MCA is locked into position Micro Curved Attachment MCA and Curved Burr Support Sleeves Curved Bur...

Page 31: ...nurled knob on handpiece is in RUN posi tion 2 Insert drive shaft of keyless driver into handpiece and ro tate 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...

Page 32: ...n 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 mount ing plate 2 Insert saw blade into opening through slot on mounting plate and align saw blade hub with locking pins in mou...

Page 33: ...ol 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 while rotating knurled knob on attachment clockwise unt...

Page 34: ... thumb and forefinger of one hand Gently pull the connector away from the console or saw The connector should remove easily If not ensure only the ridged portion of the con nector is pulled Do not pull on the smooth part of the connector as this will result in damage to the cable Note The Foot Control must be connected to the System Console See Foot Control Operating Instructions in the eMax 2 and...

Page 35: ...proximately one quarter turn until fully seated Handpiece knurled knob will move up to seat next to SpeedReducer 4 Pull SpeedReducer retaining sleeve towards handpiece Insert Hudson end of cranial perforator and release retain ing sleeve Disassembly 1 Pull SpeedReducer retaining sleeve towards handpiece and remove cranial perforator from distal end of SpeedReducer 2 Move handpiece knurled knob to ...

Page 36: ...t for any damage to the tube Anspach Electric Systems Instructions for Use Synthes 35 Visually inspect for bent or broken drive shaft and for any damage to the tube Visually inspect for bent or broken foot Angle Attachments MA D20 MA DRIVER MCA QD8 QD8 S QD11 QD11 S QD14 QD14 S Craniotomes CRANI A CRANI A R CRANI L CRANI P Straight Attachments LONG LONG S LONG 01 LONG HD MEDIUM MEDIUM HD MIA16 SHO...

Page 37: ...BS SA JLATCH 36 Synthes Anspach Electric Systems Instructions for Use Visually inspect for overall damage or missing components Visually inspect for damage to electrical cord or connector Visually inspect for damage or cracks to the housing or pedal Foot Controls E FP E FP DIR E FP DIR IRR EMAX2 FP EMAX2 FP NS EPLUS FP EPLUS FP NS ...

Page 38: ...nurled knob operates properly If the knob is hard to turn it may be lubricated Please refer to the instructions for use Visually inspect for damage to the silicone hose or to the electrical connector Connect to console and operate The handpiece should operate smoothly There is no requirement to operate with attachment or dissection tool Hand Controls E HC EMAX2 HC Handpiece E12 EMAX2 EMAX2PLUS ...

Page 39: ...uctions for Use Visually inspect for damage or cracks to the housing Visually inspect for damage to the electrical power cord Power the system and inspect for illumination of the LEDs If there is an irrigation pump present check for proper function If the irrigation flow LED display is not on press the Drop button ...

Page 40: ...rom the handpiece 2 Fully immerse the attachment in an alkaline cleaner non chlorinated detergent prepared as described on the product label at room temperature in a suitable con tainer and agitate for 15 seconds 4 Remove the brush ACB 5 Rinse the attachment in a suitable container filled with deionized distilled or purified water and agitate for 15 seconds Item Numbers 3 and 4 refer only to the S...

Page 41: ...e spray may be used on the hose to prolong its flexi bility and to facilitate foreign particle removal The handpiece should be tested by running it with an attach ment and dissection tool prior to every use for one minute to ensure proper operation If the distal tip and main body of the handpiece are uncomfortably hot to the touch return the instrument to Synthes Anspach for servicing Caution Hand...

Page 42: ...d 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 Synthes Anspach 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 de...

Page 43: ...service Hose may be kinked Unkink hose verify it is not being pinched or clamped to table Handpiece out of balance Return to Synthes Anspach for service Handpiece hose damaged Return to Synthes Anspach for service Excessive vibration of cutting burr Cutting burr may be bent Replace with new eMax 2 eMax 2 Plus cutting burr Cutting burr may not be fully seated Reassemble cutting burr and attachment ...

Page 44: ...ted Handpiece is in Safe position or cutter is not rotating Verify cutter is completely engaged and handpiece s knurled knob is in secure po sition Defective attachment Clean attachment or replace attachment Inoperative Hand Control Defective internal component Return to Synthes Anspach for service Hand Control Attachment may not be fully installed The circumferential groove on handpiece housing w...

Page 45: ...t 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 Electric Instrument System EMAX2PLUS eMax 2 Plus Handp...

Page 46: ...0100173 Synthes Inc or its affiliates Subject to modifications Synthes is a trademark of Synthes Inc or its affiliates Distributor Manufacturer The Anspach Effort Inc 4500 Riverside Drive Palm Beach Gardens FL 33410 USA Anspach Europe Ltd Aston Court Kingsmead Business Park Frederick Place High Wycombe HP11 1LA United Kingdom ...

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