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Mammotome® Biopsy System

1. 14 5 cm NN 11 3 3 cm Figure 1 11 MR Probe Dimensions Dimensions given for 145mm length probes MR Holster 13 8 35 0 cm 2 1 5 2 cm Cable length 30 9 1 m Figure 1 12 MR Holster Dimensions Chapter System Overview MR Targeting Set 1 9 4 9 cm 6 6 16 0 cm 2 0 5 1 cm Figure 1 13 MR Targeting Set Dimensions Dimensions given for 145mm length targeting set MR Interlock System 6 8 17 4 cm 3 5 8 9 cm 48 0 4 0 121 9 cm 10 1 cm 1 6 when fully extended both cables 3 9 cm Figure 1 14 MR Interlock System Dimensions Dimensions may vary by gauge size MAMMOTOME Biopsy System Service Manual Chapter 2 Theory of Operation Introduction Chapter 2 Theory of Operation describes the electronic design of the control module including system layout board to board interfaces electronic hardware software interfaces and detailed hardware design Electrical System Design Specifications The system consists of four 4 printed circuit boards the uniboard PCB assembly uniboard the interface board the connector board and the LCD inverter board The uniboard contains the main CPU LCD controller motor controllers and motor and solenoid drivers The interface board contains the motor controllers that drive externally connected motors The connector board routes signals from the back panel to the unibo
2. Control Module Repair and Replacement Procedures This section explains how to repair and replace the following components in the control module Vacuum source tube LCD assembly Uniboard PCB Vacuum pump Translational and rotational motors Solenoid Interface board if equipped Location and specification of control module fuses are also addressed Removing the Housing o Bezel fastener Gray o front o UTER o LJ CP o Top cover fastener Figure 4 1 Removing the Control Module Housing Remove the four 4 phillips head fasteners that mount the gray front bezel to the bottom of the control module Figure 4 1 Removing the Control Module Housing Remove the one 1 phillips head fastener recessed in the gray front bezel between the tubing set connection and the holster cable connections Remove the gray front bezel Remove the thirteen 13 phillips head fasteners that mount the top cover to the bottom of the control module chassis 45 MAMMOTOME Biopsy System Service Manual 5 From the rear of the unit loosen the thumbscrews and disconnect the two LCD cables fastened to the uniboard Figure 4 2 Disconnecting the LCD Assembly Cables and Ground Wire Thumbscrews Ground Wire and Fastener Figure 4 2 Disconnecting the LCD Assembly Cables and Ground Wire 6 Remove the fastener that connects t
3. Wire harness Figure 4 34 Reconnecting the Wire Harnesses to the PCB 65 MAMMOTOME Biopsy System Service Manual 2 Slide the rubber boot back towards the transmission assembly 3 Reattach the lower frame by inserting the tabs into the upper frame and pivoting the back of the frame into place Pull slightly back on the cocking levers as you insert the tabs 4 Replace the 0 050 allen head fastener attaching the upper and lower frame 5 Slide the shroud over the holster and fasten with the four 0 050 allen head fasteners 6 Push the port shaft into the spur gear Note Make sure that when the flat of the port shaft is facing up the rotation spade on the other side of the assembly is horizontal 7 Replace the retaining ring on the port shaft 8 Install the firing button and the allen head fastener 9 Using the flat surface of the port shaft as a guide push the rotation knob into place EX Holster Repair and Replacement Procedures The instructions that follow describe how to replace the following components in the EX Holster Power cord assembly Bottom housing Top housing Keypad cover Flex circuit assembly Front DC motor rotation Rotation motor extension shaft Rotation motor drive shaft Rear DC motor translation and gear Drive shafts bushings chains and gears Note All fasteners must have a pre applied bead of Loctite and be tightened with a torque driver to 2 0 5
4. 77 MAMMOTOME Biopsy System Service Manual 78 Removing the Electrical Cable with the Lemo Connector Remove the four 4 allen fasteners holding the cable breakout housings together Figure 4 52 Cable Breakout Housing Remove the top housing half Unplug the Molex connector and remove cable To reassemble reverse the above procedure Note If both housings are removed ensure that the cable ferrule aligns into the slot Ensure that the slot in the brass ferrule drops over the square boss in the housing Ensure that the round boss inside the housing fits into one of the holes in the back nut Allen fasteners Figure 4 52 Cable Breakout Housing Removing the HIB Enclosure l 2 Unwind the cable from the spool Remove the three 3 allen fasteners holding the HIB enclosure to the spool Figure 4 53 Removing the HIB PCB Pull the HIB away from the spool To reassemble reverse the above procedure Tighten the three 3 Allen fasteners from 4 to 6 in lbs until the fasteners bottom out to the backplate Removing the HIB PCB l 2 3 Remove the HIB enclosure Unplug the two 2 Molex connectors from the PCB board Remove the two 2 allen fasteners holding the PCB to the HIB enclosure Figure 4 53 Removing the HIB PCB Remove the PCB from the enclosure To reassemble reverse the above procedure Chapter 4 Repair and Replacement Procedures HIB enclosure HIB PCB Cable strain relief Mo
5. Note The thumbwheel shaft and gear do not have to be removed to service the gearbox assembly Servicing the Gearbox Assembly 2 3 4 Follow the previous steps to get to the gearbox assembly Remove the ratchet cover housing by removing the four 4 allen fasteners Pull the translation coupling assembly forward and remove Figure 4 49 Front of Gearbox Housing Pull the thumbwheel coupling forward and remove REMOTE THUMBWHEEL COUPLING TRANSLATION COUPLING ROTATION COUPLING Figure 4 49 Front of Gearbox Housing Chapter 4 Repair and Replacement Procedures 5 Remove the four 4 allen fasteners from the back gearbox cover 6 Pull the cover slightly to the rear and then remove the rotation coupling assembly from the front of the gearbox housing 7 Rotate the cover down to expose the gearbox gears without removing the thumbwheel shaft Figure 4 50 Rear of Gearbox Housing Figure 4 50 Rear of Gearbox Housing 8 Replace gears as needed Figure 4 51 Gear Locations 9 Slide the long transfer shaft to the rear and remove from the assembly 10 To reassemble reverse the above procedure Figure 4 51 Gear Locations C 18 Tooth Helical Gear onto Transfer Shaft D 27 Tooth Translational Gear to Translation Engagement Coupling E 20 Tooth Proximal Gear to Transfer Shaft F Idler Gear onto Idler Shaft Note Verify that all rotating parts rotate smoothly as the input shaft is rotated
6. Place the tabletop over the LCD assembly with the beveled tabletop surface in front of the LCD Turn the assembly over and place the turntable on the rubber surface so that the four 4 fasteners extend from the turntable Spin the turntable to expose one of the four 4 mounting holes Thread one of the shoulder bolts into the exposed mounting hole until the bolt clears the top of the turntable but Do Not tighten completely Install the remaining three shoulder bolts and completely tighten all four Pass the LCD cables speaker cable and ground wire through the top cover housing Align the four 4 fasteners in the turntable with the top cover Firmly press the LCD assembly in place so that it rests flush with the top cover Chapter 4 Repair and Replacement Procedures 24 Replace the rubber washer on each of the four 4 studs Figure 4 12 Reassembling the LCD Assembly to the Top Cover Assembly Stud washers and nut Figure 4 12 Reassembling the LCD Assembly to the Top Cover Assembly 25 Place a flat washer on each of the mounting studs except the rear stud at the back of the housing 26 With flat washers installed secure three 3 11 32 nuts onto the three studs 27 Place a strain relief over the thick LCD cable and secure to the rear mounting stud so that the cable sets on the vacuum bulkhead side of center Replacing the Uniboard PCB Assembly I Remove the remaining four 4 phillips head fasteners tha
7. W N Follow the previous steps to get to the encoder Remove Kapton tape from the encoder Remove the plastic rear cover of the encoder by unsnapping and pulling it to the rear Slide the encoder fork into the 2 small openings on the side of the encoder With the small dimple on the encoder shaft pointing up at 12 o clock insert a 035 allen wrench from the right side into slot at the 3 o clock position until it seats in the setscrew holding the encoder Figure 4 48 Removing the Encoder from the Gearbox Tongue Assembly Loosen the setscrew Note Do not remove the setscrew Remove the two 2 allen fasteners holding the encoder then remove the Encoder by sliding it to the rear Reverse above procedure to reassemble Note Do not over tighten the encoder setscrew it should just be finger tight Note The flat of the shaft must be aligned to the setscrew before tightening the setscrew Note Replace the Kapton tape on the same encoder location from which it was removed in step 2 75 MAMMOTOME Biopsy System Service Manual 76 Encoder shaft dimple in 5 035 Allen wrench Encoder fork Figure 4 48 Removing the Encoder from the Gearbox Tongue Assembly Removing the Thumbwheel Shaft and Gear WwW N Follow the previous steps to get to the thumbwheel shaft and gear Remove the coil pin from the shaft and gear Slide the shaft out from the rear and remove the gear Reverse above procedure to reassemble
8. Capture the firing mechanism with the two clamp plates and four 4 new phillips head fasteners Mount the PCB again with the three 3 phillips head fasteners Install the firing fork and the thumbscrew Chapter 4 Repair and Replacement Procedures Replacing the Safety Mechanism Components I Remove the three 5 64 allen head fasteners near the safety lever Figure 4 33 Replacing the Safety Mechanism Components Caution Safety mechanism components are under spring pressure Figure 4 33 Replacing the Safety Mechanism Components 2 Replace the defective safety mechanism components 3 Reassemble the safety mechanism in the following order a Place the firing button shaft in the channel with the tab oriented toward the transmission assembly b Use the white plastic block to hold the firing button shaft in place c Place the torsion spring in the block so that the end with the right angle bend is on top d Place the safety latch over the torsion spring ensuring that the spring end passes through the small hole in the latch 4 Place the safety cover over the entire assembly and secure with the three 3 5 64 allen head fasteners Reassembling the Holster I Connect the two wire harnesses to the PCB secure with a tie strap wrapped around the PCB and placed in the grooves on the sides Note the proper routing of the wires in Figure 4 34 Reconnecting the Wire Harnesses to the PCB
9. Check the following vacuum connections for tightness Flexible tube connections at canister lid Vacuum set cartridge connection Canister lid 2 Press to continue 1 Properly seat holster cable connector in control module 2 Press gt to continue 1 Release FORWARD key button on holster 2 Press to continue Code L3 011 L3 012 L3 019 L3 021 L3 040 L3 041 L3 042 L3 043 Message Holster REVERSE Button Activated Holster VACUUM Button Activated Inadequate Airflow Through Unit Vacuum Tubing Connections Low Speed Position Error While Homing High Speed Position Error While Homing Low Speed Position Error While in Position Sample or Clear Probe Mode High Speed Position Error While in Position Sample or Clear Probe Mode Chapter 3 Troubleshooting Possible Cause REVERSE key button pressed unintentionally VACUUM key button pressed unintentionally Airflow through control module is restricted beneath or at the back panel of the control module Vacuum set connection is loose or disconnected Tight loops in mechanical drive cable Tight loops in mechanical drive cable Object lodged in probe aperture Damaged probe Object lodged in sample retrieval area Damaged probe Corrective Action Release REVERSE key button 2 Press to continue 1 Release VACUUM key button 2 Press to continue
10. L4 016 L4 017 L4 018 L4 019 L4 020 L4 021 L4 022 L4 023 L4 024 28 Error Message Rotation Axis Motor Driver Monitoring Circuit Failed Translation Axis Motor Driver Monitoring Circuit Failed Motor Uninitialized Sequence Fail Brake Release Sequence Fail Brake Set Safety Variable Corruption Sequence Fail Position Error Sequence Fail Motor Start Sequence Fail Motor Stop Sequence Fail Current Limit Sequence Fail Vacuum Sequence Fail Motor PWM Select Enable Translational axis motor watchdog expired Rotational axis motor watchdog expired Probable Cause A failed control module circuit board A failed control module circuit board An invalid jump in the software An invalid jump in the software An invalid jump in the software Corrupted RAM An invalid jump in the software An invalid jump in the software An invalid jump in the software An invalid jump in the software An invalid jump in the software An invalid jump in the software Failed watchdog reset cycle power on system Failed motor circuitry Failed watchdog reset cycle power on system Failed motor circuitry Corrective Action Replace uniboard PCB assembly See Chapter 4 Repair and Replacement Procedures Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall
11. analog ground HGND holster ground this is the isolated holster ground PGND power ground VGND video ground this is a separate return for the red green and blue remote display signals and is tied to LGND near the LCD controller MAMMOTOME Biopsy System Service Manual Power Distribution 5V_ANLG 5V for sensitive analog circuits 5V_CTRL 5V for general digital and analog circuits 5V_DISP 5V for LCD display 5V_FOOT 5V for footpedal 3 3V_CTRL 3 3V for digital circuits 12V 12V for FET drivers and CCFT backlight inverter 48V_FILT Filtered 48V for motors solenoids and driver circuitry VHLST Holster supply voltage 6 0V to 7 5V VCC CARD Either 3 3V or 5 5V depending on the memory card inserted CPU The CPU is a Motorola Coldfire 5206e running at 40MHz UARTS 7 UART 1 holster UART 2 touchscreen Interrupts irq translational motor controller irq4 rotational motor controller irq7 DUART channel A Memory EPROM The EPROM is a single 4 Mbit 256K x 16 component The CPU performs 6 wait state reads to it A chip select and output enable are the control signals for the EPROM System Flash The Flash ROM consists of four 4 14 Mbit 2M x 8 components for a total of 8 Mbytes The CPU performs 5 wait state reads and 5 wait state writes A chip select write enable and output enable are the control signals for the Flash ROM Sy
12. 1 CAN CSAC22 2 No 601 1 EN 60601 1 and IEC 60601 1 2 50MK Shipping and Storage Temperature 35 C to 54 C Humidity 10 to 100 Relative Humidity Non Condensing Atmospheric Pressure 500 hPa to 1 060 hPa Equipment Operating Conditions Temperature 5 C to 40 C Humidity 30 to 75 Relative Humidity Non Condensing Atmospheric Pressure 700 hPa to 1 060 hPa MAMMOTOME Biopsy System Service Manual Electrical Specifications Specification SCM12 SCM23 Operating Voltage Operating Current Operating Frequency Agency Compliance Patient Isolation Protection Against Electrical Shock Operating Temperature Operating Humidity Operating Duty Cycle Fuse Ratings Degree of Protection Against Ingress of Fluids 120V 6 3 Amps Maximum 60 Hz CF USA UL60601 1 Europe IEC60601 1 IEC60601 1 2 IEC60601 1 4 Canada CSA C22 2 No 601 1 5 C 40 C 41 F 104 F 220 240V 3 Amps Maximum 50 60 Hz CF USA UL60601 1 Europe IEC60601 1 IEC60601 1 2 IEC60601 1 4 Canada CSA C22 2 No 601 1 5 C 40 C 41 F 104 F 30 to 75 Relative Humidity Non Condensing 45 Minutes On 15 Minutes Off See Chapter 4 Repair and Replacement Procedures System IPXO Footswitch IP68 45 Minutes On 15 Minutes Off See Chapter 4 Repair and Replacement Procedures System IPXO Footswitch IP68 Electromagnetic Compatibility EMC Guidance and Manufactur
13. 3432 133 3 Acquire the new Front Interface Bracket p n 3432 371 and attach to the chassis 4 Reassemble the VSO the two motors and both solenoid assemblies onto the Front Interface Bracket 5 Place washer p n 15118 over end of one of the motor assemblies see Figure 5 18 Washer Assembled onto Motor New Front Interface Bracket p n 3432 371 with recessed motor mounts Figure 5 18 Washer Assembled onto Motor Washer assembled onto motor 101 MAMMOTOME Biopsy System Service Manual 6 Insert one compression coupling p n 15117 and the lemo connector nut onto the end of the motor and tighten the two screws to 3 in Ibs to secure the coupling to the motor see Figure 5 19 Compression Coupling and DC Motor Adapter Attachment The lemo connector nut must be inserted here to facilitate attachment of the lemo connector shell in the next step DC Motor Adapter p n 3432 372 lighten to 3 in Ibs to secure coupling to both the motor and DC motor Compression adapter Coupling p n 15117 Figure 5 19 Compression Coupling and DC Motor Adapter Attachment 7 Reassemble lemo connector shell and nut to the front interface bracket see Figure 5 20 Complete DC Motor Adapter Assembly Lemo Connector T y Lemo Connector N TP Shell edt TT it H E n o im Figure 5 20 Complete DC Motor Adapter Assembly 8 Repeat steps 5 through 7 for the additional DC Motor Adapter assembly if
14. 4 of this manual for instructions and remove the top frame p n TFSA200 2 Obtain part number TFSA200B top frame with pre drilled hole See Figure 5 15 Assembling the Firing Latch Block and Safety Latch to the Top Frame that will replace the existing top frame p n TFSA200 3 Assemble the firing latch block and safety latch to the new top frame p n 3703 255 as shown in Figure 5 15 Assembling the Firing Latch Block and Safety Latch to the Top Frame Pre drilled Top Frame Firing Latch Block Safety Latch e T9 Figure 5 15 Assembling the Firing Latch Block and Safety Latch to the Top Frame 4 Place the positioning spring p n 3703 257 onto the top frame with the spring tab directed toward the back end cable and transmission end of the top frame 5 Secure the positioning spring using 4 40 fastener p n 700 001945 Torque to 8 in Ibs 1 in Ibs 6 Remove the bracket subassembly p n CEA237 123S from the transmission mounting bracket 7 Remove the manual spade from the transmission mounting bracket and replace the manual spade with manual spade with coupling assembly p n CEA442 99 as shown in Figure 5 16 Installing the Manual Spade with Coupling Assembly 8 Reassemble the ST Holster see Chapter 4 using Rotation Knob p n 3703 263 See Figure 5 17 New Rotation Knob and top frame with pre drilled hole p n TFSA200B 98 Chapter 5 System Upgrades Positioning Spring Manual Spade with Coupli
15. 7 Low voltage differential signal B 15 Unused 8 Low voltage differential signal B 16 Unused Chapter 2 Theory of Operation Uniboard Connector Board Interface The uniboard to connector board interface is a 120 pin board to board connector with the following signals a 8 UART signals 6 footpedal signals 10 remote display signals 16 data signals for memory card 26 address signals for memory card 10 control status signals to from memory card 39 signal grounds LGND e 2 VCC_CARD e 1 45V CTRL e 1 5V_FOOT e 1 relay drive signal Uniboard LCD Board Interface The uniboard to LCD interface consists of two 2 26 pin connectors one for the LCD J6 and one for the inverter touchscreen and LED signals J7 LCD Connector J6 20 LCD Control Signals 4 signal grounds LGND 2 5V DISP Inverter Touchscreen LED Connector J7 e 3 12V 3 signal grounds LGND 1 LED on off control signal e 1 backlight inverter on off control signal 1 backlight inverter brightness control 4 touchscreen signals Note The 13 signal grounds shown are not routed in the cable A 13 pin cable is used for the inverter touchscreen and LED signals Uniboard Definition The uniboard contains the main CPU LCD controller motor controllers and motor and solenoid drivers Two PLDs are used for glue logic and memory mapped I O Grounding Scheme LGND digital ground e A
16. Biopsy System Service Manual Control Module and Screen 8 8 22 2 cm 8 4 21 3 cm 12 3 31 1 cm pi 9 0 u 22 9 cm 21 5 64 6 cm 13 3 33 7 cm Figure 1 2 Control Module Screen Dimensions ST Holster and Cables Figure 1 3 ST Holster and Cables Dimensions Chapter System Overview ST Probe 12 4 31 4 cm im SIDE VIEW 9 2 cm 2 1 5 3 cm TOP VIEW Figure 1 4 ST Probe Dimensions Dimensions may vary by gauge size HH Holster and Cables f 72 5 184 2 cm 1 9 gt 4 8 cm Figure 1 5 HH Holster and Cables Dimensions MAMMOTOME Biopsy System Service Manual HH Probe 12 6 32 0 cm Figure 1 6 HH Probe Dimensions MHHI1 11 GA probe shown Dimensions may vary for other probe sizes EX Holster 8 6 21 8 cm I1 2 8 cm Figure 1 7 EX Holster Dimensions EX Probe Figure 1 8 EX Probe Dimensions HHIIBEX 11 GA probe shown Dimensions may vary for other probe sizes Chapter System Overview Footswitch 10 6 27 0 cm 5 1 13 0 cm Figure 1 9 Footswitch Dimensions Remote Keypad 1 6 2 0 4 0 cm 5 0 cm Pa v3 3 9 9 8 Figure 1 10 Remote Keypad Dimensions MAMMOTOME Biopsy System Service Manual MR Probe 5 7
17. Damaged L3 033 Probe Damaged 26 Probable Cause Translation position mismatch between the Uniboard and the Interface board Rotation position mismatch between the Uniboard and the Interface board Multiple possible causes error is attributed to damage to the translation drive train Multiple possible causes error is attributed to damage to the rotation drive train Corrective Action Press to continue The cutter will automatically retract to position 1 Press to continue The cutter will automatically retract to position 1 Unload damaged probe and load new probe as described in probe package insert Press to continue Unload damaged probe and load new probe as described in probe package insert Press to continue Error Code L4 002 L4 003 L4 004 L4 005 L4 006 L4 007 L4 008 L4 009 L4 010 Level 4 Attention Messages Chapter 3 Troubleshooting An L4 attention message terminates a procedure and instructs the operator to contact an EES Sales Representative or the Service Center a Gohmonafohmon company or Service Center ETHICON ENDO SURGERY INc A Attention Operation Terminated Contact EES Sales Representative Figure 3 6 Level 4 Attention Screen Error Message Flash ROM Integrity Failure Rotation Drivetrain Failure Translation Drivetrain Failure Vacuum Sensor Failure failed high Vacuum Sensor Failure faile
18. MAMMOTOME System during a procedure The error message on the screen tells the user specifically what to troubleshoot and repair Record the error code e g L3 001 and refer to this section of the MAMMOTOME Service Manual for corrective action fot 0 A Attention Operation md J Vacuum Tubing Connections D Figure 3 5 Level 3 Attention Screen Error Message Probe Connection Wrong Probe Adjust Green Holster Cable Probe Damaged Probe Removed Adjust Green Holster Cable Probe Damaged Probable Cause Probe is not properly loaded into holster Incorrect probe loaded into holster for desired procedure Excessive bending of green drive cable Multiple causes Probe removed from holster mid procedure Excessive bending of green drive cable Multiple causes Corrective Action Load probe as described in probe package insert Press to continue Remove probe and load appropriate probe as described in probe package insert Press to continue Straighten green drive cable Press to continue Unload damaged probe and load new probe as described in probe package insert Press to continue Reload probe or load new probe as described in probe package insert Press the EXIT button to reinitialize the probe Straighten green drive cable Press to continue Unload damaged probe and load new probe as described in probe package insert Press
19. Power Supply Lines 1kV on Input Output Lines 1kV Differential Mode 2kV Common Mode 3 Vrms from 150 kHz to 80 MHz 10 Vrms from 80 MHz to 2 5 GHz 3 A m lt 5 UT 95 dip in UT for 0 5 cycles lt 40 UT 60 dip in UT for 5 cycles lt 70 UT 30 dip in UT for 25 cycles Chapter System Overview Compliance Level 6kV Contact 8kV Air 80 MHz to 2 5 GHz 2kV on Power Supply Lines 1kV on Input Output Lines 1kV Differential Mode 2kV Common Mode 3 Vrms from 150 kHz to 80 MHz 10 Vrms from 80 MHz to 2 5 GHz 3 A m lt 5 UT 95 dip in UT for 0 5 cycles 4096 UT 60 dip in UT for 5 cycles 7096 UT 30 dip in UT for 25 cycles Guidance Relative humidity should be at least 3096 Portable and mobile RF communications equipment cell phones should not be used at close distances Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Portable and mobile RF communications equipment cell phones should not be used at close distances Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment MAMMOTOME Biop
20. Remove restrictive material s from beneath or behind the control module 2 Allow sufficient time for the control module to cool 3 Ensure that the control module is at leat 6 15 24 cm from all walls 4 Press to continue 1 Check the following vacuum connections for tightness Flexible tube connections at canister lid Vacuum set cartridge connection Canister lid 2 Press to continue Loosen or straighten cable Loosen or straighten cable Dislodge object Replace probe Dislodge object Replace probe 35 MAMMOTOME Biopsy System Service Manual Code Message L3 044 Non MRI safe input device connected to control module L3 045 Interlock box not connected 36 Possible Cause One of the following is connected to control module EX holster ST holster HH holster remote keypad footswitch Interlock box not connected to control module Corrective Action Replace incorrect holster with MR holster remove footswitch or remote keypad from ILB connection located on the back of the control module Connect interlock box to back of control module System Checks for MR Systems Symptom The control module will not power on The control module experiences excessive vibration during operation of the vacuum pump The screen will not tilt The screen will not rotate Cannot remove vacuum set cartridge from vacuum connection slot on front of control
21. Service Manual Figure 5 31 Disengaging the SCMC1 Cart from the Control Module 2 Remove the control module from the cart 3 Assemble the right and left saddle assemblies using the tongue in groove 4 Slide the saddle assemblies onto the cart aligning the holes on the saddle assembly with the holes on the cart top See Figure 5 32 Placing the Saddle Assemblies on the Cart Left saddle assembly Figure 5 32 Placing the Saddle Assemblies on the Cart 5 Place the control module on the cart and turn the locking knobs to the right to re engage the control module to the cart 6 Assemble the brackets and docking cups for each platform configuration See Figure 5 33 EX HH Bracket and Docking Cup Assembly Figure 5 34 MR Bracket and Docking Cup Assembly Figure 5 35 ST Bracket Assembly 110 Fastener 4 40 x 375 BSHCS Chapter 5 System Upgrades Fastener 10 32 x 1 2 PFHMS Fastener 10 32 x 1 2 BSHCS SS Figure 5 33 EX HH Bracket and Figure 5 34 MR Bracket and Figure 5 35 ST Bracket Assembly Docking Cup Assembly Docking Cup Assembly 7 Assemble the docking cups and brackets using the appropriate fasteners ensuring that the brackets and docking cups are oriented for the intended saddle assembly mounting block location See Figures 5 33 5 34 and 5 35 Bracket and docking cup assemblies are installed in the mounting blocks located on the left and right saddle assemblies See Figure 5 36 Ins
22. button on the following message pop up screen to return to the Event Log Review screen EVENT LOG REVIEW 0001 n1 n1 nn n amp t2 no AT 15 NAN Power An Awd cl Complete Message pop up screen eo t X c gt H Next button Figure 3 11 Copy Event and Usage Logs Pop up Screen Complete 5 Remove the PCMCIA card from the control module Note Ifthe PCMCIA card inserted into the control module contains application software the following screen appears on the display Cs EVENT LOG REVIEW MOnaak HY n9 AN NA NA INNA 191605 Power An FAVORS Card contains application software Replace with a blank card C Figure 3 12 Copy Event and Usage Logs Pop up Screen Card contains application software 6 Replace the PCMCIA card containing the application software with a blank PCMCIA card and press the Next button on the message pop up screen Chapter 3 Troubleshooting Note If the PCMCIA card inserted in the control module is not blank the following screen appears j EVENT LOG REVIEW 00N4 n1 n1 nn n amp 12 no9 n 7 15 0nn Power fin fiv95Y N Card is not blank and will be overwritten Are you sure you want to continue 99 Q VIIA Figure 3 13 Copy Event and Usage Logs Pop up Screen Card is not blank To replace the current PCMCIA card with a blank card before copying the Event and Usage Logs e Press the Back button on the pop
23. handle is facing the pedestal prior to inserting into the patient replace the targeting set if the z screw handle is broken Minimize potential damage to the seals by inserting the obturator coaxially through the thumbwheel Replace targeting set Symptom The thumbwheel does not show the rotational position of the aperture The levers fail to hold the sleeve mount in position on the targeting rail Targeting rail fails to release The thumbwheel does not rotate freely on the sleeve mount The levers jam and do not release the sleeve assembly for adjustment The buttons jam closed in the sleeve mount and the z screw cannot be adjusted except by rotation The secondary z rail slides off of the primary rail interfering with the bore of the magnet Chapter 3 Troubleshooting Possible Cause The obturator and or probe are inserted 180 degrees incorrectly during imaging no sample is retrieved during biopsy Improper aperture position during imaging Z screw interferes with bore of magnet Interference between targeting set and rail The fit of the targeting set components is too tight The fit between the levers and the sleeve mount is too tight The fit between the buttons and the sleeve mount is too tight Spring is displaced Corrective Action When properly installed the probe and obturator should insert into the targeting thumbwheel in a singular unique orientation Reinst
24. lid Press to continue Properly seat black electrical cable connector in control module Press gt to continue Properly seat footswitch connector in back panel of control module Press to continue 1 Switch off O the control module 2 Disconnect the footswitch from the control module 3 Connect the remote keypad to the control module 4 Switch on I the control module Properly seat green drive cable connector in control module Press gt to continue Connect green and blue connectors to their respective connector ports Press to continue Straighten green drive cable Press to continue Unload damaged probe and load new probe as described in probe package insert Press the EXIT button to reinitialize the probe Error Code L3 010 L3 011 Error Message Remote Keypad FORWARD Button Activated Chapter 3 Troubleshooting Probable Cause FORWARD button pressed by accident Corrective Action Release FORWARD button Press to continue REVERSE button pressed by L3 012 L3 013 L3 014 L3 015 L3 016 Remote Keypad REVERSE Button Activated Remote Keypad VACUUM Button Activated Footswitch FORWARD Pedal Activated Footswitch REVERSE Pedal Activated Footswitch VACUUM Pedal Activated Incompatible Footswitch or accident VACUUM button pressed by accident FORWARD pedal pressed by accident REVERSE pedal pressed by accident
25. liliis 47 Location and Specification of Fuses 0 0 cece cece cette tte eee eee 48 Replacing the LCD Assembly Components 49 Replacing the Uniboard PCB Assembly 53 Replacing the Interface Board Assembly 00 cece cece eee 54 Replacing the Vacuum Pump 0 0 cece ccc cece Raa pA 54 Replacing the Translational and Rotational Motors eese 56 Replacing the Solenoid 5 22 pes bPLeepREERQU Po ER ELE n 57 ST Holster Repair and Replacement Procedures eeeeeeeeeeee 58 Disassembling the Flolst r cer ret pe epe p iene eer eee 58 Replacing the Cable Assembly cesses 6l Replacing the Encoder Assembly 000s cee eee cece enn eee ee ene 62 Replacing the Mounting Bracket Assembly 62 Replacing the PCB Assembly sss teen een neee 63 Replacing the Firing Mechanism ice 63 Replacing the Safety Mechanism Components ssssseseeeee 65 Reassembling the Holster 21 52 Ue ea a UESEER E REFECHUHNI PAS 65 EX Holster Repair and Replacement Procedures sleeeeeeeeeeesA 66 Replacing the Power Cord Assembly ssssssssseee eee 66 Replacing the Bottom Housing scele 66 Replacing the Top Housing esee 67 Replacing the Keypad Cover sssseleleeeeeeeeeee e hn en 67 Replacing the Flex Circuit Assembly sss 68 Replacing the Front DC Motor Rotation issssssss IA 68 Replacing the Rotation Motor Extension Shaft
26. ramp The current limit should be set to 1OmA 15mA for SCM23 Update Figure 6 1 Electrical Safety Test Results with test results Mains to Patient Test Procedure 4 5 Leave the High Voltage port of the tester connected to the mains of the unit under test Connect the Return port of the tester to all pins of the holster electrical connector Set the tester to 3000AC volts for one second with a one second ramp The current limit should be set for 20mA Update Figure 6 1 Electrical Safety Test Results with test results Ground Continuity Test 2 Connect the unit under test to the electrical receptacle of the tester Connect the continuity port of the tester to the ground lug of the unit under test Set the tester to a limit of 30A and 0 1 Q Update Figure 6 1 Electrical Safety Test Results with test results 113 MAMMOTOME Biopsy System Service Manual Procedure Mains to Earth Ground Test Mains to Patient Test Ground Continuity Test Tested By Print name Figure 6 1 Electrical Safety Test Results Test Specification lt 10mA 20mA 0 1 Signature Date Tested Value 114 Pass Fail Chapter 7 Warranty Ethicon Endo Surgery Inc warrants this product to be free from defects in material and workmanship under normal use and preventive maintenance for the respective warranty period shown below Ethicon Endo Surgery Inc s obligation under this warranty is limited to the repa
27. the motor wire harness assemblies See Figure 5 25 Harness Routing Tle Strap Uniboard Interface Harness Power Connector Wire Harness Holster Interface Harness Figure 5 25 Harness Routing 105 MAMMOTOME Biopsy System Service Manual 8 Route the power connector wire harness p n 3432 406 over the top of the uniboard interface harness and secure the power connector wire harness the uniboard interface harness and the motor wiring harnesses with a tie strap 9 Route the end of the power connector wire harness to the power supply DC terminals Connect the black wire to terminal 3 and the white or red wire to terminal 8 See Figure 5 26 Power Supply Connection Terminal 8 amp Power Connector Wire Harness Figure 5 26 Power Supply Connection 10 Remove the tie strap securing the vacuum pump wire harness to the base plate See Figure 5 27 Power Connector Wire Harness Routing Tie Strap securing both harnesses to Base Plate Vacuum Pump Wire Harness Power Connector Wire Harness Figure 5 27 Power Connector Wire Harness Routing lI Route the power connector wire harness along the base of the uniboard alongside the vacuum pump wire harness and secure both harnesses to the base plate with a tie strap 12 Remove the second tie strap securing the vacuum pump wire harness to the base plate closest to the video board connection to the uniboard See Figure 5 28 Power Connector Wire Harness Routi
28. 2 Properly connect the footswitch to the control module 3 Switch on lI the control module Make sure the cable of the footswitch is properly connected to the control module Connect the footswitch cable If the problem persists turn the control module off to reconnect the footswitch Jiggle the cable or try another footswitch to reproduce the error and replace the footswitch if necessary Tighten the clamp by turning the clamp knob clockwise Disconnect quick connectors and reconnect 1 Unload the probe 2 Check for foreign material 3 Reload the probe Switch the control module O off or navigate to the Probe Selection Screen and reload the probe Align the rotation knob with the 12 o clock position of the ST probe 1 Unload the probe 2 Make sure the firing fork and the fork screw are completely installed Symptom The control module does not provide any signals or beeps when the buttons on the holster are pressed The Reconnect Holster Screen appears on the control module ST Probe cannot be removed from holster Cart wheels will not move Chapter 3 Troubleshooting Probable Cause Footswitch is connected to the control module Control module volume is turned down Electrical cable is loose or not connected properly Cables are not properly connected to the control module Cutter is within the sample notch Front wheels are locked Corrective Act
29. 2 and SCM23 New Pump Isolation Mount p n 700 001500 New vacuum pumps model 2669 VES44 337 or 2669 VGH 144 337 Old Vacuum Pumps model K48ZZDZH3250 or 2639VGH44 337A Old Vacuum Pumps model K48ZZDZH3250 or 2639VGH44 337A New Vacuum Pumps model 2669 VES44 337 or 2669VGH 144 337 New Vacuum Pumps model 2669 VES44 337 or 2669VGH 144 337 Description of Changes in the Isolation Mount Special Instructions Existing inventory should be depleted prior to transitioning to p n 875 000302 Existing inventory of pumps model K48ZZDZH3250 should be depleted first Existing inventory of pumps model 2639VGH44 337A should be depleted first All 4 isolation mounts must be the same version Additional washer placed before the fender washer Refer to step 5 Refer to step 15 Remaining inventory should be scrapped and replaced with p n 3432 367 Single use screw that must be discarded when removed Single use screw that must be discarded when removed Provides additional clearance for the tubing The isolation mount was changed to allow for more clearance with the new pump The new mount is for use with all versions of the vacuum pump part numbers 875 000336 875 000303 and 875 000302 The new mount requires the addition of a 7 16 Size 1 2 ID 1 1 4 OD 5 64 thick round flat washer p n 700 001930 before the fender washer to allow for clearance of the pump mount bolt Units must have a
30. MAMMOTOME System If the information specified in this section is insufficient call one of the following numbers for service and identify the error condition code that occurred 1 800 USE ENDO U S calls 1 513 337 8901 International calls English speaking only The Reconnect Holster Screen Figure 3 1 Reconnect Holster Screen appears if the holster cables are not properly connected to the control module If this screen appears perform the following steps ETHICON ENDO SURGERY INC a Gohmonafohmon company Figure 3 1 Reconnect Holster Screen I Switch off O the power to the control module 2 Reconnect the holster cables 3 Switch on l the power to the control module The Connect Remote Keypad or Footswitch Screen Figure 3 2 Connect Remote Keypad or Footswitch Screen appears only if the remote keypad or footswitch has not been connected to the control module for ST systems only ETHICON ENDO SURGERY INC a fohmonsfohmon company Figure 3 2 Connect Remote Keypad or Footswitch Screen MAMMOTOME Biopsy System Service Manual Error Code L1 001 20 The appearance of the Incompatible Holster Screen Figure 3 3 Incompatible Holster Screen indicates that the holster loaded into the control module is not compatible with the software in the control module When this message appears switch the control module off O remove the holster replace it with a compatible holster and switc
31. Mammotomes Biopsy System Service Manual company ETHICON ENDO SURGERY LLC a fohmron Table of Contents Chapter I System Overview sesssssseeeee e n ene ereraa I Purpose and Scope 6s s bees sree ng cece ede UR ooo Eo nd e pe eens e hol ena Responsibility of the Manufacturer lesse Calling for Service odore Sethe ded a Pea PAR Ee beaut wee Pa ae ds Additional Product Information 4 2 ees cana ere be naan o aed aang Rae eer a ei e System Specifications oss erbe Eee ke PAGO ae ea oe eee RUP Le deans kon eee eee Classifications os odes eeu e Le e Seu e UR oR RR UR lees kee Vea Shipping Ghd Storage i ics vend si Cottis ranr hh SE ME SEG ERR RR ead Equipment Operating Conditions csse Electrical Specifications occ ics eevee sessi e oda EERE EE ERE eae 2 Electromagnetic Compatibility EMC Guidance and Manufacturer Declarations 2 How Supplied 3 ore saepe px bese ERE oC Dax Eh AR IER ERR UR ade une stan EE N E E 4 Safety Information Warnings and Precautions llleeeee eee 4 Warning Risk of Fire sa eese sese ber ere Va RO CARGO Toe 4 Warning Electric Shock Hazard esses esent res 4 Caution ESD Sensitive Components icis 4 Caution Servicing by Qualified Personnel Only 0 cece cece eects 4 System Component Dimensions leeleeseeeeeee ence eens 5 Cart and MR Cart Upgrade and Holster Spool 0 eee
32. Removing the Lens PCB Assembly from the Top Housing I Remove the top housing 2 Remove the four 4 allen fasteners holding the containment housing to the top housing Figure 4 44 Containment Housing and PCB Wire Routing 3 Remove the containment housing and the PCB assembly 4 To reassemble reverse the disassembly procedure Note Make certain that the wires are routed in the channel properly so they are not pinched during reassembly Allen fasteners PCB wire routing Figure 4 44 Containment Housing and PCB Wire Routing 73 MAMMOTOME Biopsy System Service Manual 74 Removing the Holster Bottom from the Gearbox Tongue l 2 Remove the top housing Loosen allen fastener 5 6 turns on the thumbwheel shaft and pull the thumbwheel knob to the rear to remove tighten fastener back down to keep it from falling out Figure 4 45 Thumbwheel Knob and Gearbox Tongue Assembly Remove the seven 7 allen fasteners holding the gearbox tongue housing to the bottom housing Pull the two 2 housings apart To reassemble reverse the disassembly procedure Thumbwheel knob Gearbox tongue assembly Loosen to remove thumbwheel knob F Au Allen fasteners Figure 4 45 Thumbwheel Knob and Gearbox Tongue Assembly Removing the Cable and Strain Relief from the Gearbox Tongue Assembly l 2 3 Cable attachment housing Remove the holster bottom from the gearbox tongue Remove the three 3 allen fasten
33. VACUUM pedal pressed by accident Device other than Release REVERSE button Press to continue Release VACUUM button Press to continue Release FORWARD pedal Press to continue Release REVERSE pedal Press to continue Release VACUUM pedal Press to continue Remove other device connector from L3 017 L3 018 Remote Keypad Green Holster Cable Probe Damaged Blue Holster Cable MAMMOTOME Footswitch or Remote Keypad is connected to the control module s remote control socket Excessive bending of green drive cable Green drive cable connector is not properly connected to control module Multiple causes Excessive bending of blue drive the remote control socket and insert MAMMOTOME Footswitch or Remote Keypad connector Press to continue Straighten green drive cable Press to continue Properly seat green drive cable connector in control module Press to continue Unload damaged probe and load new probe as described in probe package insert Press to continue Straighten blue drive cable Press to Probe Damaged cable Blue drive cable connector is not properly connected to control module Multiple causes continue Properly seat blue drive cable connector in control module Press gt to continue Unload damaged probe and load new probe as described in probe package insert Press to continue 23 MAMMOTOME Biopsy Sys
34. age One 1 Year Parts and Labor Remote Keypad One 1 Year Parts and Labor UNLESS SUPERCEDED BY APPLICABLE LOCAL LAW THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF ETHICON ENDO SURGERY INC ANDIS A PURCHASER S EXCLUSIVE REMEDY IN NO EVENT SHALL ETHICON ENDO SURGERY INC BE LIABLE FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION DAMAGES RESULTING FROM LOSS OF USE PROFITS BUSINESS OR GOODWILL OTHER THAN AS EXPRESSLY PROVIDED BY A SPECIFIC LAW Ethicon Endo Surgery Inc neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Ethicon Endo Surgery Inc products There are no warranties that extend beyond the terms hereof Ethicon Endo Surgery Inc reserves the right to make changes to products built and or sold by them at any time without incurring any obligation to make the same or similar changes on products previously built and or sold by them Caution Federal USA law restricts this device to sale by or on the order of a physician 115 TULIT REF SCM12 HH11BEX MUPG4 SCM23 HH8BEX HHHC1 MHH11 STHC1 MHH11B HHEX MHH14 SCMH1 MHH8 SCMH2 MST11 SCMH3 MST11B SCMS1 MST14 SCMS2 MST8 SCMA1 MRH1 SCMSWA MRLB1 SCMSW5 SCMSW6 MFSW1 SCMC1 MKEY1 SCMC3 Ethic
35. ailure Rotation Motor Failure Management Software and Interface Board Software Communication Failure Control modulel Application software and Interface Board Software Communication Failure Chapter 3 Troubleshooting Probable Cause Corrupted RAM in Interface board Failure in the Complex Programmable Logic Device of the Interface board Failure in the ID Chip of the Interface board An invalid jump in the software on the Interface board An invalid jump in the software on the Interface board An invalid jump in the software on the Interface board A failed translation motor chip on the Interface board A failed rotation motor chip on the Interface board A failure in the signal path between the Uniboard and the Interface board A failure in the signal path between the Uniboard and the Interface board Corrective Action Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system pow
36. all ensuring that the probe and obturator seat and latch with the thumbwheel If the levers are defeated and the sleeve mount moves back and the buttons have not been activated confirm the correct orientation of the z screw lever and push the targeting back in until the z stop bottoms again Use the localization compression rails to remove the targeting Release the angulation control to ensure perpendicular retraction of the targeting If the thumbwheel does not rotate freely replace targeting set If the sleeve mount cannot be pulled away from the patient by depressing the levers the pawl can be rotated back and depressed to release the targeting rail If the buttons fail to move rotate the z screw until the buttons move If the buttons still fail to move replace targeting set Before sliding the patient into the magnet always confirm that the patient and targeting have clearance with respect to the magnet bore 39 MAMMOTOME Biopsy System Service Manual 40 Event and Usage Log Reviews The Event Log and Usage Log record system events and data for use in troubleshooting When calling for service the call center representative may require information from the Event and Usage Logs This section explains how to access information from the Event and Usage Log Review screens At the Physician Selection screen select the Event Log button to display the Event Log Review screen ETHICON ENDO SURGERY in
37. all washer p n 700 001930 inside the pump constraint well Note Ensure the smaller washer remains centered on the isolation mount when securing the mount to the pump If this washer becomes off center a noticeable rattling noise will occur when the unit is functionally tested See Figure 5 5 Isolation Mount Washer Small Washer p n 700 001930 Centered on Isolation Mount Figure 5 5 Isolation Mount Washer 91 MAMMOTOME Biopsy System Service Manual 92 6 Place a fender washer p n 700 001512 on top of the small washer See Figure 5 6 Installing a New Vacuum Pump 7 Secure the pump and two washers with a 1 4 20 x 1 1 4 torx drive button head stainless steel fastener with pre applied epoxy p n 3432 366 and torque to 120 in Ibs 5 in lbs Pump Constraint Secured to Chassis n 3432 08 P a Fender Washer p n 700 001512 Torx Drive Button Head Stainless Steel Fastener p n 3432 366 Figure 5 6 Installing a New Vacuum Pump 8 Remove one of the two 6 32 x 1 1 8 Phillips flat head screws 700 001576 holding the pump constraint See Figure 5 7 Installing the Vacuum Pump Constraint Cover 9 Place pump constraint cover 3432 129 with countersink holes facing up on top of pump constraint Screw one 6 32 x 1 1 8 Phillips flat head fastener 700 001576 into the base plate 10 Remove the second 6 32 x 1 1 8 Phillips flat head fastener and align the other countersunk hole on the pump constraint cover
38. applicable 9 Complete reassembly of control module 102 Chapter 5 System Upgrades Upgrading Regulatory Label on Control Modules SCMI2 and SCM23 This upgrade obsoletes regulatory labels D06239P02 Inspection Criteria Any control module SCM12 and SCM23 that has the heart symbol on the regulatory label must be upgraded by replacing that label with label D15611P02 Material Equipment Required Label D15611P02 Upgrade Procedure l Replace label D06239P02 with label D15611P02 Mammotome CONTROL MODULE ETHICON ENDO SURGERY sSSIF MEDICAL EQUIPMENT Ne A UL60601 1 IECGOGO1 1 CAN CSA C22 2 No 601 1 t US EN 60601 1 IEC 60601 1 2 50MK el C ois Figure 5 21 Correct Label D15611P02 103 MAMMOTOME Biopsy System Service Manual Upgrading Control Modules SCMI2 and SCM23 for EX Functionality This upgrade addresses the procedure to upgrade Mammotome control modules for Mammotome EX functionality Inspection Criteria Customers requesting Mammotome EX functionality will receive this upgrade along with application software version 5 0 Material Equipment Required Part Number Description Quantity 3432 401 Interface Board 1 3432 402 Interface Board Mounting Bracket 1 3432 406 PS to IF Board Wire Harness 1 3432 407 Uniboard to IF Board Wire Harness 1 92745A510 3 8 Hex male female nylon standoff 5 8 32 threads 3 8 length 95000A 192 8 32 X 5 16 PPHMS nylon Phillips head 5 28A0640 0A0 Ferri
39. ard and contains the memory card remote display solid state relay serial port and remote control connectors The LCD inverter board is located inside the LCD assembly and interfaces with the touchscreen and uniboard System Block Diagram EX Holster Board pS a ES Inverter Speaker JE Holster Board ST HH MR LCD Touchscreen Controller Controller Translational Axis Motor gt gt SSS AAA Controller Encoder Remote Display Port M Rotational Axis Digital otor NANA Siin S Controller ystem Extractor Controller Solenoid Drivers Interface Board Axial Vacuum qm e e m um o m Lateral Vacuum soe OO m i eee X X X X Handpiece cable ZZ Optional or User Installable Mwwwwe Mechanical Cable Vacuum Tube Figure 2 1 System Block Diagram MAMMOTOME Biopsy System Service Manual Uniboard Interface Board Interface at Interface Board Pin Signal Definition Pin Signal Definition 1 HGND 9 Holster RX input from holster 2 VHLST 10 Holster RX 11 3 VHLST 11 Holster TX output to holster 4 HGND 12 Holster TX 13 9 Translational axis holster encoder A 13 HGND 6 Translational axis holster encoder A 7 14 HGND 7 Translational axis holster encoder B 15 HGND 8 T
40. at has a pre applied bead of silicone Note All fasteners should be tightened with a torque driver to 2 0 5 in lbs unless otherwise noted Note Reapply GE silicone TSE397 C to any location from which it was removed during disassembly i e connectors Replacing the Remote Keypad I Remove the allen fastener holding the keypad strain relief to the holster Figure 4 42 Replacing the Remote Keypad 2 Note the position of the wiring During reassembly it must be placed in the same location from which it was removed 3 Pull cable to the rear to expose the wiring and the Molex connector 4 Disconnect the connector and remove the connector from the unit 5 To reassemble reverse the disassembly procedure ensuring that the wires are pushed to the side so when the strain relief is tightened down it does not pinch them Keypad strain relief Figure 4 42 Replacing the Remote Keypad 72 Chapter 4 Repair and Replacement Procedures Removing the Top Housing from the Bottom Housing I Remove the three 3 allen fasteners in the top of the housing Figure 4 43 Top Housing and Bottom Housing 2 Remove the three 3 allen fasteners in the bottom housing holding the top housing to the bottom housing 3 Unhook the Molex connector and remove from the unit 4 To reassemble reverse the above procedure Top Housing Bottom Housing Allen fasteners Allen fasteners Figure 4 43 Top Housing and Bottom Housing
41. c WY VY WY Y WY DD iaoee vio Event Log button Figure 3 7 Physician Selection Screen The Event Log Review screen lists system events in reverse chronological order The system maintains and stores over 1000 system events for retrieval The Event Log Review screen lists the following information for each recorded event read from left to right Event Number Modality e g 01 Boot Software Version Date Time and Event Type iu EVENT LOG REVIEW 00446 03 01 00 04 06 2004 12 16 05 Power On 0x25 00445 OF 01 00 04 06 2004 12 00 37 Power On 0x25 WOOAAMAM OL 01 00 04 06 2004 11 59 40 Power On 0x25 00449 02 05 00 04 06 2004 10 15 50 Power Off 00442 OF 01 00 04 06 2004 10 02 46 Power On 0x75 WOODAMMS O3 01 00 04 06 2004 10 01 32 Power On 0x25 00440 OF 01 00 04 06 2004 09 59 20 Power n 0x25 00499 02 05 00 04 06 2004 09 57 54 Exception UserLogteo B 00490 OF 01 00 04 06 2004 On 0x25 o04as7 Of 01 00 04 06 Power On On25 Wo0436 02 05 00 04 06 2904 09 36 19 Power off 00495 01 01 00 04 06 27 00494 OF 01 00 04 06 2004 i I LI On 0x25 00499 02 05 00 04 05 2004 o ort b oe Scroll Up button Scroll Down button Next button Figure 3 8 Event Log Review Screen To scroll through the event log press the Scroll Up and Scroll Down buttons The Usage Log Review screen presents a summary of usage data for the control module and the holster connected to the con
42. cece eee eee eee 5 Control Module and Screen iliis 6 ST Holster and Cables ovis cesses rare ee a eer geb ee ved RR ad ceres 6 ST Probe i ccscuassooo soc etre a entr bpgR a ada iia EE CER RR RR RR A GA 7 HH Holster and Cables eecsecsed e prr vp ePPeV PI Rd REF Renys 7 ulnPgcuI1nM fO 8 EX Holster oec bei oe toot eios ar exo Ub noU eS a ted qs 8 EX Probe eerte es eee eERPHCA IHRER PR epe Se PHPRRUCPSTPERIN EP EPI 8 upper nT 9 Remote Keypad cesse cde eee Y aae b prede d vea ea 9 MR Probe cenobii Ert u Mu Rd Na e EAE s Gaye eo Ra depu 10 MR hlolster i cec beret UE de dest aah ded PUE eget DOR ad E eee eaten 10 MR Targeting Set esses bebe perii DON I ead ee aes aaa n MR Interlock System ici eese egre Re bh RE meRERE REPRE REOR wiadeces E Chapter 2 Theory of Operation sssssseeeee he 13 INCPOGUCHION 5 6 EEUU 13 Electrical System Design Specifications 0 0c cece eee eee 13 System Block Diagram eta ue we ee RR ene R TRACER EEE E REE HH e qid 13 Uniboard Interface Board Interface at Interface Board 6 ccc eee eee 14 Interface Board EX Holster Interface 06 ccc ccc ete eee eens 14 Interface Board ST and HH Holster Interface 0 cece eects 14 Interface Board MR Holster Interface 00 cece ccc eee ee 14 Uniboard Connector Board Interface 06 cence ene tenes I5 Uniboard LCD Board Interface 0 cece m 15 Uniboord Definit
43. d low or Regulator Failure Uncommanded Movement of Rotation Motor Uncommanded Movement of Translation Motor Rotation Axis Current Limit Circuitry Failed Translation Axis Current Limit Circuitry Failed Probable Cause Corrupted ROM A failed motor encoder A failed motor encoder A failed VSO A failed vacuum sensor A failed pump A failed VSO A failed vacuum sensor A failed rotation motor controller or encoder A failed translation motor controller or encoder A failed control module circuit board A failed control module circuit board Corrective Action Reinstall software See Software Installation Guide Perform Internal Encoder Test If test fails see Hardware Checks in this chapter Perform Internal Encoder Test If test fails see Hardware Checks in this chapter Perform Vacuum Regulator Test If test fails see Hardware Checks in this chapter Perform Vacuum Regulator Test If test fails see Hardware Checks in this chapter Perform Internal Encoder Test If test fails see Hardware Checks in this chapter Perform Internal Encoder Test If test fails see Hardware Checks in this chapter Perform Excessive Torque Test If test fails see Hardware Checks in this chapter Perform Excessive Torque Test If test fails see Hardware Checks in this chapter 27 MAMMOTOME Biopsy System Service Manual Error Code L4 011 L4 012 L4 013 L4 014 L4 015
44. e Display The LCD is a 65640 x 480 TFT display The remote display port can support standard CRTs with a 15 pin high density subminiature D style connector Speaker The speaker is used for error and user interface tones The National LM4871 uses a 1W audio amplifier Relay The AC power supplied to the vacuum pump is controlled by a solid state relay The relay is controlled by the microcontroller through the PLD Serial Port The serial port allows a PC to communicate with the microprocessor This consists of a DB 9 connector and standard RS 232 signals Footswitch Remote Keypad The remote control port allows a footswitch or remote keypad to be used with the control module The remote control signals are available to the microprocessor through the PLD Four signals are used for remote control status and two signals are used for remote control identification MAMMOTOME Biopsy System Service Manual Vacuum Control System The vacuum is controlled through a closed loop analog control circuit consisting of a vacuum sensor DAC regulation circuitry and VSO voltage sensitive orifice The vacuum set point is set by software through the DAC and the regulating circuitry will maintain the vacuum set point by adjusting the VSO in a closed loop fashion An initial reading determines the zero vacuum offset of the system This setting will typically be 250 mV for the Sensym ASCX30DN sensor 8 bit ADC 5V reference 0 01953 V count The sen
45. e Placement SCREW SCREW SCREW Figure 4 37 Kapton Tape Placement Replacing the Front DC Motor Rotation Note The rotation motor p n D13392P01 02 is smaller than the translation motor p n D13393P01 02 Loosen the two 2 fasteners in the front of the motor The translation motor must be loosened and moved to get to the inside screw of the rotation motor Disconnect the motor connector from the flex circuit assembly Tilt the back of the motor up until the fasteners clear the mounting brackets then slide it back to separate the motor shafts To replace the motor reverse the above procedure making certain that the wires from the motor are turned inward next to the circuit board and that the alignment washers are seated properly into the brackets Replacing the Rotation Motor Extension Shaft I 2 With the motor removed press the coil pin from the motor shaft Replace the extension shaft and press in a new coil pin Chapter 4 Repair and Replacement Procedures Replacing the Rotation Motor Drive Shaft l With the motor and extension shaft removed remove the two 2 fasteners securing the drive shaft cover in place 2 Remove the drive shaft cover 3 Tilt the back of the drive shaft up and slide the drive chain from the sprocket 4 To reinstall the drive shaft reverse the above procedure making certain that the anti rotation feature of the drive shaft bushing locks into the small slot on the
46. e intake valve 18 Place the vacuum tubing connection on the valve and tie the strap to secure Replacing the Translational and Rotational Motors I Remove the four 4 phillips head fasteners and two 2 standoffs in the channel of the interface bracket Figure 4 17 Replacing the Translational and Rotational Motors K Socket receptacle Interface bracket loa E ER I 1 7A 5 a I 1 T c Three 3 SER WE phillips head O Fasteners Coupling fasteners that Standoffs mount motor f RN enm WI I9 to interface 9 Eds Nut bracket hidden from view d L tc A Figure 4 17 Replacing the Translational and Rotational Motors With a 1 5 mm allen wrench loosen the four 4 fasteners on each motor coupling Remove the adapter for the motor to be replaced Remove the nut and socket receptacle for the adapter Remove the coupling for the adapter Remove the three 3 phillips head fasteners mounting the motor to the interface bracket Remove the defective motor on ou A A W M Install the replacement motor from the front of the control module as follows a Mount the translation motor with the blue wires on the right side of the bracket angle it so that the encoder wire harness is between 0 and 30 b Mount the rotational motor on the left side of the bracket an
47. e sprocket shaft assemblies Figure 4 40 Sprocket Locations 8 TOOTH 11 TOOTH Figure 4 40 Sprocket Locations 70 Chapter 4 Repair and Replacement Procedures 6 To replace the drive shaft assemblies reverse the above procedure Check the drive chains to make certain that the loops are facing upward Figure 4 41 Chain Loops LOOPS FACING UPWARD Figure 4 41 Chain Loops Note Make certain that the locator tabs on the bushings are turned sideways 9 o clock and 3 o clock so that they lock into the top of the supports Figure 4 38 Replacing the Rotation Motor Drive Shaft 71 MAMMOTOME Biopsy System Service Manual MR Holster Repair and Replacement Procedures The instructions that follow describe how to remove or replace the following components of the MR Holster Replacing the Remote Keypad Replacing the Top Housing Removing the Lens PCB Assembly from the Top Housing Removing Holster Bottom from the Gearbox Tongue Removing the Cable and Strain Relief from the Gearbox Tongue Assembly Removing the Input Gears and Cover Removing the Encoder from the Gearbox Tongue Assembly Removing the Thumbwheel Shaft and Gear Servicing the Gearbox Assembly Removing the Electrical Cable with Lemo Connector Removing the HIB Enclosure Removing the HIB PCB Removing or Replacing the Drive Cable Note If the housing seals are damaged the housing must be replaced with a new housing th
48. e to the inside of the cart 83 MAMMOTOME Biopsy System Service Manual 84 4 5 6 Guide Phillips head fastener Figure 4 58 Replacing the Pull Out Drawer Guides Replace the guides and secure with phillips head fasteners Reinstall the drawer Close the door Replacing the Fastener Plate l 2 3 Open the cart door Empty the top shelf inside the cart Using a short handled phillips head screwdriver loosen and remove the four 4 fasteners that secure the fastener plate to the underside of the cart top Figure 4 59 Replacing the Fastener Plate Loosen the two knobs until the entire assembly that includes the fastener plate two knobs and two e clips can be removed Replace the entire assembly Close the cart door Fastener plate Knob and e clip Phillips head fastener Figure 4 59 Replacing the Fastener Plate Introduction Chapter 5 System Upgrades The following upgrades should be inspected for and performed as required on the MAMMOTOME Control Module SCM12 amp SCM23 Part Assembly Original Condition Software Software Regulatory Label Ground Wire Hardware Warranty Label Uniboard Pump Wiring Vacuum Pump and Isolation Mounts Vacuum Tubing DC Motor Adapter Regulatory Label Hand Held any version 3 0 and prior Stereotactic any version 2 0 and prior p n 880 000360 or p n 880 000389 without a heart symbol in the u
49. eattaching the Tubing for proper orientation Note Due to the memory properties of the tubing proper orientation on the T connector is critical to prevent the tubing from bending when reattached to the bulk head union 95 MAMMOTOME Biopsy System Service Manual Tubing Should Be Reattached to the T Connector So that the Curvature in the Tubing Orients the Tube towards the Ceiling Figure 5 12 Reattaching the Tubing 6 Obtain a 90 Elbow Adapter p n 700 001929 if it is not already installed in the control module and place it in the underside portion of the bulk head union with the valve oriented away from the vacuum pump See Figure 5 13 90 Elbow Adapter Placement for proper orientation 90 Elbow Adapter P N 700 001929 Oriented toward Front Bezel Figure 5 13 90 Elbow Adapter Placement 7 Reattach the main housing to the base plate 8 Insert the end of the vacuum tubing into the 90 Elbow Adapter When completed the tubing should be oriented as shown in Figure 5 14 Vacuum Tubing Orientation no portion of the tubing should touch either the inside of the canister well or the Uniboard 96 Chapter 5 System Upgrades Figure 5 14 Vacuum Tubing Orientation 9 Complete the reassembly of the control module according to the instructions in Chapter 4 of this manual 97 MAMMOTOME Biopsy System Service Manual Replacing the ST Holster Rotation Knob I Disassemble the ST Holster see Chapter
50. eee e 90 Description of Changes in the Isolation Mount lille eee eee 90 Description of Changes in the Pump Mount Screws 000 ce cee eee eee 90 Disposition of Old Vacuum Pump and Related Components 00 00s e ee 9 Procedures for Installing New Pump and Components 000 c eee eee 9I Vacuum Tubing Upgrade 1 525 coser eme Ren eere ere eee eed ee oe Rada a 94 MAMMOTOME Biopsy System Service Manual Table of Contents continued Inspection Critetia eorr Gere Res RES HER x et ex ERU UE 94 Upgrade Instructions sireeni oe EA P ox e iei d acu a baee dad 94 Replacing the ST Holster Rotation Knob 0 0 cece eee eee 98 Coil Pin Replacements niri ee RO angie e RERBA RU meena E A OR agin auntie a oU 100 Materials Equipment Required ccc ees 100 Inspection Criteria Upgrade Identification scele 100 UP grade Procedure oto bcd Cara ae Pup doeet d he dabei Sey 100 Quality Assurance else pe ee er ER PER a POE PER See ee 100 DC Motor Adapter Upgrade reet sects sane SER adage dee eee cr Rol ca 101 Inspection Criterid tcr oreet tir ENESE ENNER EINER EE ace Dredd 101 Materials Equipment Required 00 cee eee 101 Upgrade Procedure dedere Ere eee tie beaded 101 Upgrading Regulatory Label on Control Modules SCMI2 and SCM23 103 Inspection Critetid sese eee e RRERCERRUE TC ER REF GE E EE 103 Materials Equipment Required c
51. em Service Manual 38 Symptom Cart wheels will not move The probe will not lock into the holster The control module does not provide any signals or beeps when the buttons on the holster are pressed The holster keypad does not respond when the keys are pressed Possible Cause Front wheels are locked Foreign material is lodged in the holster base or blocking the holes in the probe base Defective probe Control module volume is too low Faulty cable Targeting Set Troubleshooting for MR Systems Symptom Cradle locking tab does not securely hold the cradle in place with the z rail The handle on the z screw is defeated or the handle breaks The seal is torn One or more of the targeting set components is damaged or missing Possible Cause Cradle not seated properly Cradle locking tab broken The lever is not oriented toward the pillar and deflects past the stop or breaks the handle A sharp object such as the blade cuts or tears the seal Multiple possibilities Corrective Action Unlock the cart wheels Unload the probe check for foreign material and reload the probe Replace probe At the Volume and Vacuum Settings toolbar pop up screen increase the control module volume Replace keypad cable Corrective Action Reseat cradle ensuring that a clicking sound is heard to indicate that it has locked Replace cradle Make certain that the z screw
52. enoid Note These fasteners are found on the white tubing set connection block Remove the solenoid taking note of its mounting orientation Install the replacement solenoid Note The solenoid on the left is mounted so that the wire harness comes out of the top while the solenoid on the right is oriented so that the label is on the top Tighten the three 3 5 32 allen head fasteners Restore the wire harness connection to the uniboard PCB assembly 57 MAMMOTOME Biopsy System Service Manual ST Holster Repair and Replacement Procedures The instructions that follow describe how to replace the following components in the ST holster Cable assembly Encoder assembly Transmission mounting bracket assembly e PCB Firing mechanism Safety mechanism components To replace one or more of these components first follow the instructions in Disassembling the Holster Disassembling the Holster I Remove the rotation knob from the rear of the holster by gently pulling the knob straight back Figure 4 19 Removing the Rotation Knob Rotation knob Figure 4 19 Removing the Rotation Knob 2 Using a 5 64 allen wrench remove the fastener in the firing button 3 Remove the firing button Figure 4 20 Removing the Firing Button Firing button Figure 4 20 Removing the Firing Button 58 Chapter 4 Repair and Replacement Procedures Remove the retaining ring that captures the port shaft This ring is c
53. er Declarations The MAMMOTOME Biopsy System requires special precautions regarding electromagnetic compatibility EMC and must be installed and used in accordance with the EMC information provided in this installation guide The MAMMOTOME Biopsy System is intended for use in the electromagnetic environments specified below The installer and user of the system must ensure that the MAMMOTOME Biopsy System is used only in these environments Electromagnetic Emissions Emissions Test RF Emissions CISPR 11 The MAMMOTOME Biopsy System uses RF energy for its internal functions Therefore the system RF emissions are low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Harmonic Emissions IEC 61000 3 2 Voltage Fluctuations Flicker Emissions IEC 61000 3 3 The MAMMOTOME Biopsy System is suitable for use in establishments other than domestic and those directly connected to public low voltage power Compliance Guidance Group 1 Class A supply networks NA NA Electromagnetic Immunity Immunity Test Electrostatic Discharge IEC 61000 4 2 Radiated RF IEC 61000 4 3 Electrical fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Conducted RF IEC 61000 4 6 PowerFrequency Magnetic Fields IEC 61000 4 3 Voltage Dips Short Interrupts and Variations on Power Supply Lines TEC 61000 4 11 IEC 60601 Test Level 6kV Contact 8kV Air 3 Vrms 2kV on
54. er and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Replace the Interface board assembly if the test fails Cycle system power and allow the Interface board to perform a Power On Self Test Inspect the wiring harness for continuity Uniboard to Interface board Cycle system power and allow the Interface board to perform a Power On Self Test Inspect the wiring harness for continuity Uniboard to Interface board 29 MAMMOTOME Biopsy System Service Manual 30 Hardware Checks Symptom The control module will not power on After turning the control module on the screen is blank the green LED is not illuminated but the cooling fan is running Probable Cause Control module is not connected to an electrical source Voltage of the control module is inappropriate for the electrical system being used Mains power fuse is open Power supply fuse is open Uniboard PCB fuse is open Uniboard LCD cable not properly connected Defective uniboard PCB assembly Corrective Act
55. ers from the cable strain relief Remove the cable attachment housing by removing the five 5 allen fasteners Figure 4 46 Thumbwheel Knob and Gearbox Tongue Assembly Note Two 2 of the fasteners are slightly longer than the other three and must be put back in the correct locations While holding the rubber dampener slide the drive cable assembly to the rear and remove Disconnect the power cable from the encoder To reassemble reverse the disassembly procedure ensuring that the wiring harness for the encoder is routed properly Input gear cover Two 2 long fasteners Figure 4 46 Removing the Cable and Strain Relief from the Gearbox Tongue Assembly Chapter 4 Repair and Replacement Procedures Removing the Input Gears and Cover l 2 Follow the previous steps to get to the input gear cover Remove the three 3 allen fasteners holding the input gear cover in place Figure 4 47 Removing the Input Gears and Cover Remove the cover input gears and bushings Raise the long input shaft slightly to remove all the bushings Note Do not raise the input shaft too high or it will bend Do not bend the shaft To reassemble reverse the above procedure ensuring that the bushings are seated properly Tighten the gear cover fasteners to only 1 in lbs Bushings Input gears Bushings Input shaft Figure 4 47 Removing the Input Gears and Cover Removing the Encoder from the Gearbox Tongue Assembly a
56. f Control Module Voltage Amperage Size Type Fuses Model Rating Rating Two fuses on SCMI2 25V 10A 3AG Glass inside of back SCM23 250V 5A 5x20mm Glass panel Two fuses on Both 250V 6 3A 5x20mm Ceramic board power supply Uniboard FI Both 250V 3 15A 5x20mm Glass Uniboard F2 Both 250V IA 5x20mm Glass ig uS Mains fuss B A si i Uniboard fuses Power supply fuses Behind fan Figure 4 5 Fuse Location 48 Chapter 4 Repair and Replacement Procedures Replacing the LCD Assembly Components I Remove the four 4 11 32 fasteners from the underside of the top cover assembly Figure 4 6 Underside of the Top Cover Assembly 11 32 Fasteners 11 32 Fasteners Be Figure 4 6 Underside of the Top Cover Assembly Carefully pull the LCD assembly off of the cover pulling the cables through the top hole From the bottom of the LCD assembly spin the bracket to expose and remove each of the four 4 shoulder bolts with a 1 8 allen wrench Figure 4 7 Removing Shoulder Bolts from the Bottom of the LCD Assembly Shoulder bolt Figure 4 7 Removing Shoulder Bolts from the Bottom of the LCD Assembly 49 MAMMOTOME Biopsy System Service Manual 4 Slide the white tabletop cover off of the assembly 5 Remove the two 2 3 16 standoffs from the round base Figure 4 8 Removing Standoffs from the Round Base 3 16 Standoff Figure 4 8 Removing Standoffs from the Round Base 6 Remove
57. f the unit Reassemble the control module 107 MAMMOTOME Biopsy System Service Manual Mammotome EX Identification I Affix the EX label to the lower left corner of the rear bracket See Figure 5 30 Location of Mammotome EX Upgrade Label Screw locations on Fan Assembly Figure 5 30 Location of Mammotome EX Upgrade Label 108 Chapter 5 System Upgrades MR Cart Upgrade Kit This upgrade addresses the procedure to upgrade Mammotome cart assemblies for Mammotome MR functionality Inspection Criteria Customers requesting Mammotome MR functionality will receive this upgrade Material Equipment Required Part Number Description Quantity NA Left Saddle Assembly 1 NA Right Saddle Assembly 1 23561 052 EX Dual Docking Cup 1 04 05 020 F ST Bracket 1 04 05 020 E EX Mounting Bracket 1 02 01 001 Holster Saddle 1 04 05 020 MI Tube Set Hanger 1 23570 109 Warning Label 2 23570 105 Parts Kit 1 16789 011 MR Docking Cup Bracket 1 23570 128 MR Docking Cup 1 25025 055 Fastener 10 32 x 1 2 PFHMS SS 2 25021 021 Fastener 4 40 x 375 BSHCS 2 25025 052 Fastener 10 32 x 1 2 BSHCS SS 2 23153 001 1 16 Hex Shortarm 1 22006 003 1 8 Hex Shortarm 1 23154 001 1 8 Hex Combo Box amp Open 1 Assembly Instructions I Open the SCMC1 cart door and turn the locking knobs to the left to disengage the cart from the control module See Figure 5 31 Disengaging the SCMC1 Cart from the Control Module 109 MAMMOTOME Biopsy System
58. gle it so that the encoder wire harness is between 150 and 180 9 Connect the encoder and motor power wire harnesses to the uniboard PCB assembly 56 16 17 Chapter 4 Repair and Replacement Procedures Slide the motor coupling over the motor shaft until the coupling bottoms out Tighten the two 2 fasteners Slide the plastic jam nut onto the coupling so that the chamber is on the motor side Slide the motor adapter onto the motor coupling until the adapter bottoms out Secure the adapter to the motor coupling with the screws to a torque of 3 Ibs 0 2 Ibs Remove and discard the used thread sealant tape from the green or blue receptacle From the rear of the receptacle wrap new thread sealant tape clockwise around the threads no less than two complete revolutions Note Make sure that the receptacle is properly seated aligned with the alignment notch Torque the jam nut to 30 5 in Ibs 1 in Ib Reinstall and secure the two 2 standoffs with the four 4 phillips head fasteners Replacing the Solenoid To XN 5 32 Allen head fastener Cy Identify the solenoid in need of replacement Figure 4 18 Replacing the Solenoid Solenoid c o IKSS Figure 4 18 Replacing the Solenoid Disconnect the solenoid wire harness from the uniboard PCB assembly Using a 5 32 allen wrench remove the three 3 allen head fasteners for the defective sol
59. h on lI the control module This screen may vary depending on software version ETHICON ENDO SURGERY INC a fohmensfohmon company YOU HAVE CHOSEN AN INCOMPATIBLE HOLSTER FOR THIS SOFTWARE Figure 3 3 Incompatible Holster Screen Level Error Messages Level 1 messages are retained in the system event log but do not appear on the screen Error Message Probable Cause Corrective Action End of Life Real Time Clock Dead battery No action Level 2 Attention Messages An L2 attention message appears on the screen for 10 seconds During this time the user may press the SERVICE button to make the message disappear After the 10 second period the message automatically disappears The user may proceed under these conditions The SERVICE button remains on the screen after the attention message has disappeared so the user may recall the attention message Record the error code e g L2 001 and refer to this section for corrective action 6 A Attention Maintenance L2 001 E ob o Figure 3 4 Level 2 Attention Screen Chapter 3 Troubleshooting Error Code L2 001 L2 002 Error Code L3 001 L3 002 L3 003 Error Message Attention Maintenance Level 3 Attention Messages Probable Cause Product life of holster is diminishing Corrective Action Replace used holster with a new holster An L3 attention message temporarily suspends the
60. he tie strap and unplug the two connectors Figure 4 24 Removing the Tie Strap Around the PCB Assembly Warning Do not pull on the wires in order to remove the connectors Move the connector back and forth to loosen and remove Note To replace the firing mechanism see Replacing the Firing Mechanism To replace the PCB assembly see Replacing the PCB Assembly Tie strap Figure 4 24 Removing the Tie Strap Around the PCB Assembly Remove the two 3 32 allen head fasteners that mount the transmission assembly to the upper frame Figure 4 25 Removing the Tie Strap Around the PCB Assembly Phillips head fastener 3 32 Allen head fastener Upper transmission clamp Figure 4 25 Removing the Upper Transmission Clamp Hold the loose rotation gear in place during removal and secure with a piece of tape To remove the upper transmission clamp remove the phillips head fastener and the 3 32 allen head fastener Note To replace the cable assembly see Replacing the Cable Assembly To replace the encoder see Replacing the Encoder Assembly To replace the transmission bracket assembly see Replacing the Mounting Bracket Assembly Chapter 4 Repair and Replacement Procedures Replacing the Cable Assembly I 2 ou hk WwW N Remove the two drive cables from the lower clamp Remove the 3 32 allen head fastener securing the bottom clamp in place Figure 4 26 Replacing the Cable Assembly Bottom clamp Stra
61. he yellow and green ground wire from the LCD assembly to the chassis Disconnect the two pin wire harness from J10 of the uniboard 8 On the underside of the top cover where the vacuum tubing passes through to the top of the cover directly below the plastic threads slide the gray collar of the tubing connection upwards to free the top cover from the internal tubing and connector Figure 4 3 Freeing the Top Cover from the Internal Tubing and Connector 9 Replace all faulty control module components and reinstall the control module housing Note Make certain to reconnect the ground wire to the chassis when reinstalling thecontrol module housing Vacuum Tubing OLAS amp Figure 4 3 Freeing the Top Cover from the Internal Tubing and Connector 46 Chapter 4 Repair and Replacement Procedures Replacing the Flexible Vacuum Source Tube I Disconnect the tube from the center port of the canister lid Figure 4 4 Replacing the Flexible Vacuum Source Tube cris Tube Vacuum Connecto Figure 4 4 Replacing the Flexible Vacuum Source Tube Remove the clamp with a sharp instrument if necessary Remove the tube from the vacuum connector Insert the new tube over the vacuum connector and secure it with the clamp ua amp WwW N Connect the new tube to the center port of the canister lid 47 MAMMOTOME Biopsy System Service Manual Location and Specification of Fuses Location o
62. hroud is closed Replacing the PCB Assembly 2 3 Remove the three 3 phillips head fasteners with the captured star washers Figure 4 29 Replacing the PCB Assembly Phillips head fastener Figure 4 29 Replacing the PCB Assembly Install the new PCB and fasten with the three 3 phillips head fasteners Calibrate the PCB Replacing the Firing Mechanism I 2 Remove the three 3 phillips head fasteners with the captured star washers to free the PCB Loosen the thumbscrew and remove the firing fork Figure 4 30 Removing the Firing Fork Firing fork Thumbscrew Figure 4 30 Removing the Firing Fork 63 MAMMOTOME Biopsy System Service Manual 64 Remove the four 4 phillips head fasteners and the two clamp plates Figure 4 31 Removing the Clamp Plates Clamp plates Phillips head fasteners Figure 4 31 Removing the Clamp Plates Remove the firing mechanism from the frame Slightly compress the firing spring and drop the new firing mechanism into place Note Ensure that the two nylon bushings are in the U channels Figure 4 32 Nylon Bushings in the U Channel Warning While under compression the firing spring may be unstable Note For optimal performance apply Krytoxe lubricant to all moving metal to metal interfaces Firing spring ylon bushing and clamp plate Figure 4 32 Nylon Bushings in the U Channels
63. icted in Figure 5 1 Ground Screw Location Upgrade Instructions Install parts in the following sequence See Figure 5 2 Installing the Ground Wire Screw p n 700 001638 Lockwasher p n 705 000025 01 Small ground cable from power supply Nut p n 700 001660 Lockwasher p n 705 000025 01 Large ground wire from back panel Lockwasher p n 705 000025 01 Nut p n 700 001660 Ground Screw Location Figure 5 1 Ground Screw Location Figure 5 2 Installing the Ground Wire 87 MAMMOTOME Biopsy System Service Manual Uniboard Upgrade 88 This upgrade addresses a power up condition with the Mammotome Control Module When power is first applied only the fan turns on the user must then cycle the power off then back on to power up the control module Inspection Criteria All SCM12 SCM23 Uniboard PCB assemblies with an ECN number of 017789 or lower must receive the following rework Material Equipment Required 30 AWG Solid Teflon Wire Two 2 10 KQ Resistors Loctite 454 Accelerator 712 Solder and soldering iron Upgrade Instructions I Following the instructions in Chapter 4 of the MAMMOTOME Service Manual remove the Uniboard 2 Add two 2 10 kQ resistors to J3 One resistor shall be soldered directly to the top pad in the second column which is in the first row of J3 from the Top Left side of the Uniboard The second resistor sha
64. in lbs Replacing the Power Cord Assembly I Remove the two 2 phillips head fasteners from the power cable mount and slide the assembly straight back to remove 2 Inspect seal on bottom housing If seal is broken or damaged replace the housing 3 To replace slide the assembly back into the jack and push forward insert the two 2 phillips head fasteners and tighten Replacing the Bottom Housing I Remove the power cable assembly 2 Remove the phillips head fastener from the rear of the housing 3 Holding the bottom housing at the rear pull the housing up and rotate toward the front of the holster taking care not to break the locking tabs on the front of the housing Figure 4 35 Replacing the Bottom Housing 4 Inspect seals on bottom housing If seal is broken or damaged replace the housing 5 To replace the bottom housing reverse the above procedure 66 Locking tabs Chapter 4 Repair and Replacement Procedures Bottom housing Top motor mount cover Figure 4 35 Replacing the Bottom Housing Replacing the Top Housing u WwW N Keypad Remove the power cable assembly Remove the bottom housing Remove the six 6 phillips head fasteners holding the top motor mount and top housing together Pull the top housing away from the top motor mount Figure 4 36 Replacing the Top Housing Inspect the seals on the top housing and around the keypad cover for damage If damaged the top housing must be re
65. in relief Allen head fastener Mounting bracket Figure 4 26 Replacing the Cable Assembly Press the strain relief of the defective electrical cable out of the bracket Press the strain relief of the new cable into the mounting bracket Install the lower transmission bracket using a new 3 32 allen head fastener Place the two drive cables back into their respective places in the bottom clamp Ensure that the encoder mates with the translational cable Place the encoder in the bottom clamp with the label and wires facing up Slip the wire harness of the encoder through the opening in the top clamp and attach the top clamp to the bottom clamp with the phillips head fastener and a new 3 32 allen head fastener Warning Do not over tighten the phillips head fastener since this may damage the threads in the clamp Remount the transmission bracket to the upper frame making certain the electrical cable and encoder wire harness are routed to avoid damage when the shroud is closed 6l MAMMOTOME Biopsy System Service Manual Replacing the Encoder Assembly I Uncouple the encoder assembly from the drive cable and lift it out of the bottom transmission clamp Figure 4 27 Replacing the Encoder Assembly Encoder assembly Bottom transmission clamp Mounting bracket Figure 4 27 Replacing the Encoder Assembly 2 Place the new encoder assembly in the bottom clamp with the label and wires facing up Make sure that the e
66. ion 1 Switch off O the control module 2 Disconnect the footswitch from the control module 3 Connect the holster to the control module 4 Switch on lI the control module At the Procedure Screen increase the volume of the control module Make sure the electrical cable is securely seated in the connector port on the front of the control module Switch off O the control module and reconnect the cables Retract the cutter proximal to the sample notch Unlock the cart wheels 33 MAMMOTOME Biopsy System Service Manual 34 L3 Attention Screens for MR Systems An L3 attention message temporarily suspends the MAMMOTOME System during a procedure The error message on the screen tells the user specifically what to look for in order to rectify the situation and continue with the procedure Record the code e g L3 006 and refer to this section for the appropriate corrective action Code L3 002 L3 006 L3 007 L3 010 Message Probe Damaged Vacuum Tubing Connections Holster Cable Disconnected Holster FORWARD Button Activated Possible Cause Multiple possibilities Vacuum set connection is loose or disconnected The holster is not properly connected to control module FORWARD key button pressed unintentionally Corrective Action 1 Unload damaged probe 2 Load new probe 3 Press fi to continue 4 Select NEW PROBE at the YOU HAVE EXITED THE PROCEDURE screen 1
67. ion Make sure the power cord is properly connected to the back of the control module and to a grounded electrical outlet Verify the voltage of the control module is appropriate for the electrical system being used A product information label on the back of the control module lists the product code and electrical specifications See Chapter 1 System Overview for electrical specifications Check the two Mains fuses and replace if necessary as described in Chapter 4 Check the two power supply fuses and replace if necessary as described in Chapter 4 Check the two uniboard PCB assembly fuses and replace if necessary as described in Chapter 4 Ensure proper connection of cable or replace as necessary Replace the uniboard PCB assembly as described in Chapter 4 Symptom The control module experiences excessive vibration and or noise during operation of the vacuum pump Screen will not tilt Screen will not stay upright Screen will not rotate Screen rotates over 350 The vacuum set cartridge cannot be removed from the vacuum connection slot on the front of the control module Chapter 3 Troubleshooting Probable Cause Control module is not secured to the top of the cart Vacuum set connections are loose The top housing of the control module is not properly fastened The pump is not properly mounted The pump muffler is loose Defective vacuum pump Screen is being adjusted inco
68. ion dec eee Re thn aac E RN EI per eee pd 15 MAMMOTOME Biopsy System Service Manual Table of Contents continued Chapter 3 Troubleshooting seessleee eee rununu nenne 19 Introduction 52 re ph eon ee aR wa a RE UP d ew an pb EN reca eden 19 Error ajo DE pp cp 19 Level I Error Messages cesis beds da aarnde ce eee god Ma baa Pepe EDU 20 Level 2 Attention Messages 0 cece ence cece ence ahhh nnn 20 Level 3 Attention Messages 2 6 cece ence eee eee hh hh ee eet eens 21 Level 4 Attention Messages 0 cece cece eee eee eee teen ne 27 Hardware Checks ooo ehe ee dotado dna ba c anthangoh nete EA Re nO ert tye 6 30 L3 Attention Screens for MR Systems 0 cece c eect ete e 34 System Checks for MR Systernis 54 iier ocius e ela a Dp RR Gow ag Bb an S Seen as 37 Targeting Set Troubleshooting for MR Systems 2 0 ce eee eee eee eese 38 Event and Usage Log Reviews 2 cece cece cee eee hn 40 Copying the Event and Usage Logs to a Memory Card 0 cece eee eee teens 4l Chapter 4 Repair and Replacement Procedures esseeeee eee 45 Introduction 3 0 0 0 ahaa petit a tectae dies Pee a arc orate race anaes Deer oe eer kan anne 45 Control Module Repair and Replacement Procedures 0 0 e cece eee eee eens 45 Removing the Housing 0 00 0008 4460 0s0 eese eese de eG rw uet e ey eds 45 Replacing the Flexible Vacuum Source Tube
69. ir or replacement at its option of any product or part thereof which has been returned to Ethicon Endo Surgery Inc or its Distributor within the applicable time period shown below and which examination disclosed to Ethicon Endo Surgery Inc s satisfaction to be defective This warranty does not apply to any product or part thereof that has been 1 adversely affected due to use with devices manufactured or distributed by parties not authorized by Ethicon Endo Surgery Inc 2 repaired or altered outside Ethicon Endo Surgery Inc s factory in a way so as to in Ethicon Endo Surgery Inc s judgement affect its stability or reliability 3 subjected to improper use negligence or accident or 4 used other than in accordance with the design and use parameters instructions and guidelines for the product or with functional operational or environmental standards for similar products generally accepted in the industry Ethicon Endo Surgery Inc s products are warranted for the following periods after delivery to the original purchaser ST Holster One 1 Year Parts and Labor HH Holster One 1 Year Parts and Labor EX Holster One 1 Year Parts and Labor MR Holster One 1 Year Parts and Labor MR Interlock System One 1 Year Parts and Labor Control Module One 1 Year Parts and Labor Footswitch One 1 Year Parts and Labor Support Arm One 1 Year Parts and Labor Cart and Cart Upgrade Kit One 1 Year Parts and Labor Software Pack
70. itee and Loctite 242 are registered trademarks of the Loctite Corporation DuPont Krytoxe is a registered trademark of the DuPont Company Dow Corninge is a registered trademark of the Dow Corning Corporation Windowse is a registered trademark of Microsoft Corp 1486 is a registered trademark of Intel Corp Adobee and Acrobate are registered trademarks of Adobe Systems Inc Manufactured by Ethicon Endo Surgery Inc 4545 Creek Rd Cincinnati Ohio 45242 1 800 USE ENDO U S calls 1 513 337 8901 International calls English speaking only customersupport eesus jnj com MAMMOTOME Biopsy System Service Manual Chapter System Overview Purpose and Scope This Service Manual contains information required to troubleshoot service and repair the MAMMOTOME Biopsy System Assembly drawings diagrams and electrical schematics are contained in the document titled MAMMOTOME Biopsy System Assembly Drawings Diagrams and Electrical Schematics Complete operating instructions for the MAMMOTOME Biopsy System including installation and cleaning instructions are contained in the MAMMOTOME Biopsy System Operator s Manuals supplied with the system software The service instructions in this manual are for use only by personnel qualified to repair and service the equipment described in this manual Responsibility of the Manufacturer Ethicon Endo Surgery Inc is responsible for the safety reliability and performance of this equipment onl
71. ixture 5 Position the coiled pin p n CLDP047X187MCP on the top hole of the port shaft and lower the Arbor Press to secure the coiled pin in the machined hole of the port shaft 6 On the blade side of the bracket subassembly scribe an X above the left spade lug This may be done with an engraving tool or a sharp object as the metal is soft 7 Reassemble the ST Holster using port shaft using new port shaft p n CEA663 855 and new spur gear p n CEA 6064 855 Quality Assurance Update Quality Assurance inspection criteria to include the inspection for the upgrade X above the left spade lug for all ST Holsters with a serial number of GST042479 and lower 100 DC Motor Adapter Upgrade Chapter 5 System Upgrades This upgrade is being implemented to improve the reliability of the DC motor adapter specifically when the translational and rotational motor assemblies are subjected to an impact force Inspection Criteria This upgrade applies to SCM12 and SCM23 systems with serial numbers less than 1202403 and 2301080 respectively Material Equipment Required Part Description Old Part Number New Part Number Compression Coupling 700 001526 15117 13mm Round Spacer N A 15118 DC Motor Adapter 3432 156 3432 372 Front Interface Bracket 3432 133 3432 371 Upgrade Procedure I Remove the front interface bracket 2 Discard the following components e Compression Coupling 700 001526 DC Motor Adapter 3432 156 e Front Interface Bracket
72. le connector from the Interface board 2 Remove the remaining two 2 phillips head fasteners that secure the interface board bracket to the capacitor and front interface bracket assemblies 3 Remove the phillips head fasteners that secure the interface board to the bracket 4 Replace the interface board and secure it to the bracket 5 Reconnect all wiring harnesses 6 Secure the bracket to the chassis with the two 2 fasteners Replacing the Vacuum Pump I Carefully remove the tie strap securing the tubing to the intake valve of the defective vacuum pump Figure 4 14 Replacing the Vacuum Pump Note Do Not cut or damage the tubing 2 Remove the tubing from the valve Remove the intake valve from the pump and retain for reassembling to the new vacuum pump 4 Remove the muffler and brass fittings from the exhaust of the defective vacuum pump Tie strap Valve b 7 VERSER T Figure 4 14 Replacing the Vacuum Pump 54 Ground wire Chapter 4 Repair and Replacement Procedures Disconnect the two spade connectors from the capacitor and remove the one 1 phillips head fastener that secures the green and yellow pump ground wire to the chassis Figure 4 15 Removing the Capacitor Spade Connectors and Vacuum Pump Ground Wire Spade connector Figure 4 15 Removing the Capacitor Spade Connectors and Vacuum Pump Ground Wire Disconnect the brown power wire from tab 2 of the solid state relay on the back panel
73. lex connectors Figure 4 53 Removing or Replacing the Drive Cable Removing or Replacing the Drive Cable I Remove the HIB enclosure 2 Remove the four 4 allen head fasteners from the cable strain relief Figure 4 53 Removing or Replacing the Drive Cable 3 Disconnect the Molex connectors from the PCB 4 Remove the cable from the HIB enclosure 5 To reassemble reverse the above procedure Support Arm Repair and Replacement Procedure The support arm consists of a table brace and clamp quick connectors for easy assembly a flexible tube for adjusting positioning and a coil for supporting the cables To disassemble the support arm for repair Figure 4 54 The Support Arm I Remove the cable support coil from the flexible arm by releasing the quick connector that connects the coil and the arm 2 Remove the flexible arm from the table brace by releasing the quick connector that connects the arm to the brace 3 Unthread the clamp and table brace from the examination table by turning the clamp knob counterclockwise 4 Reassemble the support arm replacing worn or damaged components 79 MAMMOTOME Biopsy System Service Manual Cable Quick support connector coil Flexible arm Quick connector Table brace Clamp Clamp knob Figure 4 54 The Support Arm Cart Assembly Repair and Replacement Procedures This section describes how to replace the following cart assembly components Cart handle e Holste
74. ll be added directly to the bottom pad in the second column which is in the second row of J3 refer to Figure 1 below for proper orientation 3 Obtain a 30 AWG Solid Teflon Wire and trim to size to route from the Positive post of C90 to both 10 kQ resistors opposite side of J3 connection The insulation on the wire will need to be stripped at both ends and in the middle where it will contact the center resistor See Figure 5 3 Upgrading the Uniboard for proper orientation 4 Add two drops of Loctite 454 Accelerator 712 to the PCB to secure the rework 5 Reinstall the Uniboard according to Chapter 4 of this manual Location EF of 4 A Rework bc T E Ro ee P Location of Loctite Location and Orientation of Two 2 10 kO Resistors 30 AWG Solid Teflon Wire Figure 5 3 Upgrading the Uniboard Chapter 5 System Upgrades Routing of Pump Wiring Vibration from the vacuum pump translates through the pump wires and can result in the insulation of the wires rubbing off if they contact a sharp surface such as the edge of the power supply bracket This routing of the pump wires secures both wires away from the edges of the power supply bracket Inspection Criteria Inspect the routing of the brown and blue wires supplying power to the vacuum pump If the brown and blue wires are not secured to the pemstud on the power supply bracket with a tie strap then this upgrade must be performed Material Equipment Requi
75. ll four 4 of the same version of the mount the mounts are not interchangeable on a unit due to differences between the two versions of mounts Description of Changes in the Pump Mount Screws The screws used for securing the isolation mounts to the pump were modified to Standardize the application of a thread locker material that prevents the fastener from loosening due to both the vibration and heat induced by the vacuum pump Improve the strength of the fastener head by changing to a torx drive that would minimize stripping of the fastener head while tightening the fastener to 120 in lbs Chapter 5 System Upgrades The new fasteners p n 3432 366 and p n 3432 367 with the pre applied epoxy do not require the application of Loctite They can be distinguished from the older screws by both a change in the head of the fastener hex vs torx drive and a change in material black oxide vs stainless steel The new and old fasteners are interchangeable on both the SCM12 and SCM23 control module unit models There is no requirement to replace all four 4 fasteners on a unit when one is changed Fasteners will only be replaced if inspection reveals that they have loosened or are defective Due to the single use feature of the pre applied epoxy once the new fastener p n 3432 366 or p n 3432 367 is removed it must be discarded and replaced with a new part Disposition of Old Vacuum Pump and Related Components Remaining inventor
76. module Chapter 3 Troubleshooting Possible Cause Control module is not connected to an electrical source Incompatible voltage Internal malfunction Control module is not secured to the top of the cart Vacuum set connections are loose Internal malfunction Incorrect screen adjustment Screen has been fully rotated in one direction Vacuum set cartridge will not disengage from control module Corrective Action Ensure that the power cord is properly connected to the electrical socket on the back panel of the control module and to a grounded electrical outlet Verify that the voltage of the control module is appropriate for the electrical system in use A product information label on the back of the control module lists the product code and electrical specifications Contact an EES sales representative or service center for service Ensure that the control module is correctly and completely secured to the top of the cart Check all the connections of the vacuum set to ensure tightness A leak in the vacuum system may lead to excess vibration during vacuum pump operation Contact an EES sales representative or service center for service Adjust the screen using the screen handle located behind the screen Rotate the screen in the opposite direction Press down on the locking tab of the vacuum set cartridge and pull out to remove from control module 37 MAMMOTOME Biopsy Syst
77. module 3 Connect the footswitch to the control module 4 Switch on lI the control module Error Code L3 025 L3 026 L3 027 L3 028 L3 029 Error Message Remote Keypad FORWARD Button Activated Remote Keypad REVERSE Button Activated Remote Keypad VACUUM Button Activated Invalid Translation Move Error Invalid Rotation Move Error Chapter 3 Troubleshooting Probable Cause FORWARD key pressed unintentionally Defective keypad contacts on EX Holster REVERSE key pressed unintentionally Defective keypad contacts on EX Holster VACUUM key pressed unintentionally Defective keypad contacts on EX Holster Translation position mismatch between the Uniboard and the Interface board Rotation position mismatch between the Uniboard and the Interface board Corrective Action Release FORWARD key button 2 Press to continue Replace circuit board on EX Holster 1 Release REVERSE key button 2 Press to continue Replace circuit board on EX Holster 1 Release VACUUM key button 2 Press to continue Replace circuit board on EX Holster Press to continue The cutter will automatically retract to position 1 Press to continue The cutter will automatically retract to position 1 25 MAMMOTOME Biopsy System Service Manual Error Code Error Message L3 030 Invalid Translation Move Error L3 031 Invalid Rotation Move Error L3 032 Probe
78. n is to reduce the opportunity for the vacuum tubing to rub against the inside of the canister well of the main housing therefore resulting in additional noise within the MAMMOTOME Biopsy System Inspection Criteria A visual inspection is all that is required to determine if the unit already has the modification After removing the bezel and main housing inspect for the presence of the 90 Elbow Adapter p n 700 001929 and verify that the end of the vacuum tubing is 4 5 in length See Figure 5 9 Vacuum Tubing Upgrade _ Elbow Adapter 4 5 Length of Vacuum Tubing Figure 5 9 Vacuum Tubing Upgrade Upgrade Instructions l Remove bezel and main housing 2 Remove tie strap and vacuum tubing from the T connector refer to picture above only the tubing identified as 4 5 in length should be removed in this step 3 Inspect tubing to determine the presence of rubbing and annotate this in the service record of the device See Figure 5 10 Inspecting the Tubing 94 Chapter 5 System Upgrades Rubbing Figure 5 10 Inspecting the Tubing 4 Cut the original tubing to 4 5 in length See Figure 5 11 Cutting the Original Tubing for proper measurement Tubing Cut to 4 5 Measuring Length of Tubing Only Original Tubing Approximately 9 in Length Figure 5 11 Cutting the Original Tubing 5 Reattach the tubing to the T connector and secure with a tie strap p n 920 000036 refer to Figure 5 12 R
79. ncoder mates with the translational cable Figure 4 28 Mating the Encoder Assembly with the Translational Cable Mating features Translational cable Figure 4 28 Mating the Encoder Assembly with the Translational Cable 3 Recalibrate the PCB Replacing the Mounting Bracket Assembly I Lift the two drive cables out of the bottom transmission clamp Figure 4 27 Replacing the Encoder Assembly Remove the 3 32 allen head fastener that secures the bottom clamp in place Press the strain relief of the electrical cable out of the bracket Press the strain relief of the electrical cable into the new mounting bracket assembly Install the lower transmission bracket using a new 3 32 allen head fastener ou hk W NM Place the two drive cables back into their respective places in the bottom clamp Make sure that the encoder mates with the translational cable 7 Place the encoder in the bottom clamp with the label and wires facing up 62 Chapter 4 Repair and Replacement Procedures Slip the wire harness of the encoder through the opening in the top clamp and attach the top clamp to the lower clamp with the phillips head fastener and a new 3 32 allen head fastener Warning Do not over tighten the phillips head fastener since this may damage the threads in the clamp Remount the transmission bracket to the upper frame making certain the electrical cable and encoder wire harness are routed to avoid damage when the s
80. nections of flexible arm seem loose The probe will not lock into the holster 32 Probable Cause Remote keypad is not properly connected to the control module Remote keypad was working but the cable became disconnected from the control module Remote keypad was not connected to the control module when the control module was turned on Footswitch cable is not properly connected to the control module Footswitch was working but the cable became disconnected from the control module A short exists in the cable Clamp is not tight enough Quick connectors are not fastened correctly Foreign material is lodged in the holster cavity or blocking the holes in the probe body slot One of the Procedure Screens is active Rotation knob is not aligned with 12 o clock position of the probe ST only Probe housing slot is not properly seated into the firing fork Corrective Action 1 Switch off O the control module 2 Properly connect the remote keypad to the control module 3 Switch on lI the control module Make sure the cable of the remote keypad is properly connected to the control module Connect the remote keypad cable If the problem persists power the control module off O and reconnect the remote keypad 1 Switch off O the control module 2 Properly connect the remote keypad to the control module 3 Switch on lI the control module 1 Switch off O the control module
81. ng Assembly Figure 5 16 Installing the Manual Spade with Coupling Assembly New rotation knob Figure 5 17 New Rotation Knob 99 MAMMOTOME Biopsy System Service Manual Coil Pin Replacement Materials Equipment Required Part Description Old Part Number New Part Number Manual Spade Assembly CEA442 99S CEA665 318 Coiled Pin CLDP031X187MDPS CLDP047X187MCP Port Shaft CEA237 707S CEA663 85S Spur Gear AIN1 N32012 S CEA664 85S Bracket Sub Assembly CEA 237 123S CEA666 31S Inspection Criteria Upgrade Identification All ST Holsters with serial numbers of GST042479 and lower will require inspection for the upgrade Each unit that is upgraded S N GST042479 and lower will have an X scribed into the Bracket Sub Assembly above the left spade lug to enable a visual inspection for the presence of the upgrade Upgrade Procedure I Disassemble the ST Holster completing the steps up to and including removal of the shroud and bottom frame described in Chapter 4 of this manual 2 Remove the e clip that secures the existing spade assembly p n CEA442 99 to the bracket subassembly p n CEA237 123S 3 Remove the existing spade assembly and replace it with manual spade assembly p n CEA665 31S securing it in place with the e clip and washer included with the assembly 4 Place the port shaft in the Mammotome ST Holster Pin Assembly Fixture installed in the Arbor Press aligning the hole in the port shaft with the pin in the f
82. ng II Base Plate location to securg wire harnesses with tie strap Video Board Connection to Uniboard Figure 5 28 Power Connector Wire Harness Routing II 106 Chapter 5 System Upgrades 13 20 21 Route the power connector wire harness alongside the vacuum pump wire harness and secure both harnesses to the base plate with a tie strap Using an ESD safe technique remove the interface board from the packaging Place the interface board p n 3432 401 on the interface board mounting bracket and secure it with five 5 nylon standoffs p n 92745A510 and five 5 nylon fasteners p n 95000A192 Place the Interface PCBA on the base plate aligning bracket holes with corresponding mounting hole on the interface bracket and the rubber foot mountingscrew and secure using the previously removed hardware See Figure 5 29 Interface Board Connections Connect the holster interface harness from the front interface bracket to the interface PCBA Power Connector Wire Harness connection to Interface Board Holster Interface Harness connection to Interface Board Attachment points of Interface Board Uniboard Interface to Base Plate Harness connection to Interface Board Figure 5 29 Interface Board Connections Connect the uniboard interface harness to the interface PCBA Connect the power connector wire harness to the interface PCBA Record the serial number of the interface board in the service history record o
83. of the control module Remove the center fastener at pin 2 of the terminal block P1 of the power supply to free the blue power wire of the defective pump Remove the four 4 1 4 20 x 1 1 2 fasteners on the underside of the chassis with a 5 32 allen wrench Figure 4 16 Removing the Four 1 4 20 x 1 1 2 Fasteners on the Underside of the Chassis 1 4 20 x 1 1 2 fastener O o Figure 4 16 Removing the Four 1 4 20 x 1 1 2 Fasteners on the Underside of the Chassis Remove the defective vacuum pump Place the new pump over the mounting pads ensuring that the intake port is the closest port to the uniboard Secure the pump with the four 4 1 4 20 x 1 1 2 fasteners treated with Loctitee 242 on the threads Torque the fasteners to 120 Ibs 5 Ibs Fasten the ground wire from the pump to the chassis using the 8 32 x 1 2 phillips head fastener removed in step 5 55 MAMMOTOME Biopsy System Service Manual 13 Twist the two black wires from the pump four to seven times and connect them to the capacitor There is no required polarity 14 Plug the brown wire from the pump into tab 2 on the solid state relay on the back panel assembly 15 At pin 2 of P1 of the power supply fasten together the blue neutral wire from the pump and the blue neutral wire from the back panel 16 Replace the brass fittings and the muffler with the muffler facing down toward the base 17 Replace th
84. on Endo Surgery Europe GmbH Hummelsbuetteler Steindamm 71 22851 Norderstedt Germany Johnson amp Johnson AG CH 8957 Spreitenbach SWITZERLAND Ethicon Endo Surgery Inc Cincinnati OH 45242 2839 USA 1 800 USE ENDO ETHICON ENDO SURGERY LLC a fohmonsfohweon company ETHICON ENDO SURGERY LLC EES LLC 2008 Guaynabo Puerto Rico 00969 USA P43538P04
85. opper in color and can be found at the back of the rotation knob Figure 4 21 Removing the Retaining Ring Note This step requires the use of external retaining ring pliers McMaster Carre p n 58225A23 Retaining ring Figure 4 21 Removing the Retaining Ring Carefully push the port shaft forward and remove it taking care not to remove or misalign the gear Figure 4 22 Removing the Port Shaft Port Shaft Manual Spade with Coupling Assembly Figure 4 22 Removing the Port Shaft Using a 0 050 allen head wrench remove the four 4 fasteners that mount the gray shroud to the bottom of the holster Figure 4 23 Removing the Gray Shroud Remaining 0 050 allen head fastener 0 050 allen head fasteners Figure 4 23 Removing the Gray Shroud Slide the shroud upward and remove Note To replace safety mechanism components see Replacing the Safety Mechanism Components 59 MAMMOTOME Biopsy System Service Manual 10 12 13 14 60 Remove the one 1 remaining 0 050 allen head fastener to enable the separation of the upper and lower frames To remove the lower frame pull slightly back on the arming levers This will free the tabs at the front of the frame Slide the rubber boot 1 to 2 down the cables and away from the holster There is a tie strap around the PCB assembly This tie strap secures the encoder wire harness and the electrical cable wire harness to the PCB Remove t
86. ore in a safe place temporarily Open the cart door and remove all items from inside the cart Inside the cart locate the locking knobs that secure the control module to the top of the cart Turn the locking knobs to the left counter clockwise until you can easily remove the control module from the top of the cart Remove the control module from the top of the cart Rubber pads on the bottom of the control module fit into indentations on the top of the cart Store the module in a safe place temporarily Close the cart door Rest the cart on one side exposing the four casters Protect the handle and the holster receptacle and bracket by wrapping with a clean cloth Figure 4 57 Replacing a Caster Lock casters in place making certain that the wheels do not prevent access to any of the serrated flange allen head fasteners securing the casters to the base plate Loosen and remove the serrated flange allen head fasteners with a 3 8 allen wrench Replace the caster s making certain that the locking mechanism faces the front of the cart Note The steer lock casters are mounted at the rear of the cart below the handle mounts the total lock casters are mounted in front of the cart Torque each allen head fastener to 20 in lbs o sy Dracaena Serrated lt gt flange nuts en SS Holster bracket Chapter 4 Repair and Replacement Procedures pe d Serrated flange allen head fastener Zo gt Fi Cas
87. oth motors External Motor Drivers The interface board contains two motor drivers one for the translational motor and one for the rotational motor Both motors are controlled through a closed loop circuitry via a PWM signal generated by the PLD Motor Watchdog Circuitry A motor watchdog stops each motor in the event of a motor driver failure The PWM signal sent to the motor driver is limited to 97 to guarantee a low pulse every PWM period This low pulse resets a watchdog counter in the PLD If the watchdog counter is not reset in 1 ms a relay is switched to short the motor to stop it similar to the brake function of the motor driver Real Time Clock The real time clock is a Benchmarq bq4842 Before this component is successfully read it must be written with the current date and time This action coupled with the clearing of the oscillator bit starts the real time clock and readies the watchdog module for use Introduction Error Codes Chapter 3 Troubleshooting Chapter 3 Troubleshooting contains helpful information for identifying and correcting MAMMOTOME System malfunctions This chapter is divided into two major sections 1 Error Codes with associated messages probable cause s and recommended corrective action s 2 Hardware Checks including symptom failure probable cause s and recommended corrective action s The following section lists the possible error conditions that may occur during operation of the
88. ould be performed by qualified personnel only System Component Dimensions Component Cart Cart with MR Upgrade and Holster Spool Control Module and Screen ST Holster and Cables ST Probe HH Holster HH Probe EX Holster EX Probe Footswitch Remote Keypad MR Probe MR Holster MR Targeting Set MR Interlock System Cart and MR Cart Upgrade and Holster Spool 32 5 82 5 cm Weight 104 Ibs 47 2 kg 180 5 Ibs 81 8 kg 58 Ibs 26 3 kg 2 3 Ibs 1 0 kg 34 Ibs 16 kg 1 6 Ibs 738 g 24 Ibs 110 g 56 Ibs 255 g 28 Ibs 128 g 3 8 Ibs 1 7 kg 24 Ibs 11 kg 32 Ibs 146 g 4 0 Ibs 1 8 kg 16 Ibs 07 kg 55 Ibs 25 kg 45 7 cm Figure 1 1 Cart Dimensions Chapter System Overview Size Dimensions See Figure 1 1 Cart Dimensions See Figure 1 1 Cart Dimensions See Figure 1 2 Control Module Screen Dimensions See Figure 1 3 ST Holster and Cables Dimensions See Figure 1 4 ST Probe Dimensions See Figure 1 5 HH Holster Dimensions See Figure 1 6 HH Probe Dimensions See Figure 1 7 EX Holster Dimensions See Figure 1 8 EX Probe Dimensions See Figure 1 9 Footswitch Dimensions See Figure 1 10 Remote Keypad Dimensions See Figure 1 11 MR Probe Dimensions See Figure 1 12 MR Holster Dimensions See Figure 1 13 MR Targeting Set Dimensions See Figure 1 14 MR Interlock System Dimensions 18 3 46 5 cm 35 5 cm MAMMOTOME
89. over the pump constraint lI Screw the second 6 32 x 1 1 8 Phillips flat head fastener into the pump constraint cover and torque both screws to 14 in lbs 1 in lb Countersunk Hole on Pump Constraint Cover 3432 129 Figure 5 7 Installing the Vacuum Pump Constraint Cover Chapter 5 System Upgrades Repeat steps 3 through 11 to install the remaining pump components Complete the installation of the pump according to the instructions in Chapter 4 of this manual On the inside of the main housing add a 90 Elbow Adapter p n 700 001929 to the bulkhead fitting Note Placement orientation of the 90 elbow Adapter is extremely important See Figure 5 8 90 Elbow Adapter Placement 90 Elbow Adapter 700 001929 Oriented toward Front Bezel 48 32 Phillips Pan Head Fastener 700 000396 2 Figure 5 8 90 Elbow Adapter Placement On the LCD assembly replace one of the 48 32 x 1 2 Phillips Pan Head Fastener p n 700 001496 with an 8 32 x 3 8 Phillips Pan Head Fastener p n 700 000396 2 This fastener is located toward the front of the LCD Assembly the change allows sufficient clearance so that no contact is made with the top of the pump See Figure 5 8 90 Elbow Adapter Placement for identification of the correct fastener to change Reassemble the control module as described in Chapter 4 of this manual 93 MAMMOTOME Biopsy System Service Manual Vacuum Tubing Upgrade The purpose of this modificatio
90. placed To replace the top housing reverse the above procedure Top housing Figure 4 36 Replacing the Top Housing Replacing the Keypad Cover Note The keypad cover is glued to the top housing to create a seal 2 3 4 5 Remove the power cable assembly Remove the bottom housing Remove the six 6 phillips head fasteners holding the top motor mount and top housing together Pull the top housing away from the top motor mount Replace the top housing the new top housing includes the keypad 67 MAMMOTOME Biopsy System Service Manual 68 Replacing the Flex Circuit Assembly 2 3 4 5 Remove the power cable assembly Remove the bottom housing Remove the six 6 phillips head fasteners holding the top motor mount and top housing together Pull the top housing away from the top motor mount Turn the top motor mount upside down and unplug the motors from the flex circuit assembly Use a small flat screwdriver to separate the plug from the receptacle being careful not to pull the wires out of the plug Slide the Flex Circuit Assembly from underneath the motors and pull it up off of the alignment post then remove the Assembly To replace the Flex Circuit Assembly reverse the above procedure making certain that the board slides far enough under the motors to keep it from being pinched by the top housing Apply Kapton Tape over the bare connectors on top of the Flex Circuit Assembly See Figure 4 37 Kapton Tap
91. pper left hand area of the label See Ground Wire Installation instructions in this chapter No label present All Uniboards 3432 007 ECN 017789 or earlier Wires not routed under the power supply bracket See Change in Vacuum Pump and Components instructions in this chapter See Vacuum Tubing Upgrade instructions in this chapter See DC Motor Adapter Upgrade instructions in this chapter See Regulatory Label Upgrade instructions in this chapter Upgrade to v4 1 or higher For installation instructions refer to the MAMMOTOME Software Installation Guide p n P40491P01 with the SCMSWS software Mandatory v4 1 or higher For installation instructions refer to the MAMMOTOME Software Installation Guide p n P40491P01 with the SCMSWS software Mandatory Remove existing label Mandatory and replace with p n D06239P02 See Ground Wire Mandatory Installation instructions in this chapter Place label p n 3432 325 Mandatory over one screw under the front bezel See Uniboard Upgrade Mandatory instructions in this chapter See Routing of Pump Mandatory Wiring instructions in this chapter See Change in Vacuum As needed Pump and Components instructions in this chapter See Vacuum Tubing Mandatory Upgrade instructions in this chapter See DC Motor Adapter Domestic Upgrade instructions Mandatory in this chapter Intl As needed See Regulatory Label Mandatory Upgrade in
92. r receptacle and bracket Power cord wrap posts Casters Cart door latch Cart door and hinges e Pull out drawer guides e Fastener plate 80 Chapter 4 Repair and Replacement Procedures Replacing the Cart Handle Remove the four 4 1 4 20 serrated allen head fasteners from the handle mounts with the 3 8 box wrench supplied with the cart Figure 4 55 Replacing the Cart Handle Remove the handle from the handle mounts Slide the new handle into the two handle mounts on either side of the cart Line up the two 2 nuts located in the bottom of the handle with the slots on the underside of the handle mounts Fasten the handle with four 4 1 4 20 serrated allen head fasteners and the 3 8 box wrench Note Do Not fully tighten the fasteners until all fasteners have engaged the bottom of the handle Torque each allen head fastener to 200 in Ibs Cart handle Handle mount Po RK Au 1 4 20 Serrated allen head fasteners Power cord wrap post 3 8 Box wrench Figure 4 55 Replacing the Cart Handle Replacing or Relocating the Holster Receptacle and Bracket The cart has slots on either side to accept the receptacle bracket allowing for right or left mounting of the holster receptacle To replace or relocate the receptacle bracket Figure 4 56 Replacing or Relocating the Holster Receptacle and Bracket Remove the two 2 10 32 flange nuts securing the bracket in place with the 3 8 box wrench s
93. ranslational axis holster encoder B 9 16 HGND The type of holster connected to the control module determines the following two pin configurations Interface Board EX Holster Interface Pin Signal Definition Pin Signal Definition 1 HGND 9 Unused 2 VHLST 10 Unused 3 Holster ID 11 Unused 4 ID Communication Port 12 Unused 5 Translational Motor Drive CW 13 Unused 6 Translational Motor Drive CCW 14 Extend Switch active low T Rotational Motor Drive CW 15 Retract Switch active low 8 Rotational Motor Drive CCW 16 Vacuum Switch active low Interface Board ST amp HH Holster Interface Pin Signal Definition Pin Signal Definition 1 HGND 9 Holster RX input from holster 2 VHLST 10 Holster RX 11 3 VHLST 11 Holster TX output to holster 4 HGND 12 Holster TX 13 3 Translational axis holster encoder A 13 Rotational axis holster encoder A 6 Translational axis holster encoder A 7 14 Rotational axis holster encoder A 15 7 Translational axis holster encoder B 15 Rotational axis holster encoder B 8 Translational axis holster encoder B 9 16 Rotational axis holster encoder B Interface Board MR Holster Interface Pin Signal Definition Pin Signal Definition 1 HGND 9 Holster RX input from holster 2 VHLST 10 Holster RX input from holster 3 VHLST 11 Holster TX output to holster 4 HGND 12 Holster TX output to holster 5 Low voltage differential signal A 13 Unused 6 Low voltage differential signal A 14 Unused
94. red Tie strap Upgrade Instructions I The brown wire from the pump plugged into relay tab 42 is routed under the power supply bracket and behind the pemstud See Figure 5 4 Routing of Pump Wiring 2 The blue wire from the pump blue neutral wire from the back panel and plugged in to pin 2 of P1 of the power supply is routed under the power supply bracket and behind the pemstud See Figure 5 4 Routing of Pump Wiring Brown and Blue Pump Power Wires Must Be Routed behind the Pemstud and under the Power Supply Bracket Figure 5 4 Routing of Pump Wiring 89 MAMMOTOME Biopsy System Service Manual Change in Vacuum Pump and Components 90 Part Number Part Description 875 000303 875 000336 875 000302 700 001500 700 001930 700 000396 2 700 001529 3432 367 3432 366 700 001929 Old Vacuum Pump model 2639VGH44 337A New Vacuum Pump model 2669VES44 337 New Vacuum Pump model 2669VGH144 337 New Pump Isolation Mount 7 16 Size 1 2 ID 1 1 4 OD 5 64 Thick Round Flat Washer Zinc Plated 8 32 x 3 8 Phillips Pan Head SEM Screw for LCD Turntable 1 4 20 x 1 1 2 Black Oxide Hex Drive Button Head Screw 1 4 20 x 1 1 2 Stainless Steel Torx Drive Button Head Screw with pre applied epoxy 1 4 20 x 1 1 4 Stainless Steel Torx Drive Button Head Screw with pre applied epoxy 90 Elbow Adapter For Use With All SCM23s All SCM12s All SCM23s All versions of pumps for SCM1
95. rrectly Damage to the screen tilt locking mechanism Screen has been fully rotated in one direction Rotation stop tabs broken Locking tab is not being pressed Corrective Action Ensure the control module is correctly and completely secured to the top of the cart Check all the connections of the vacuum set to ensure tightness A leak in the vacuum system may lead to excess vibration during pump operation Ensure that all of the screws for the housing are in place and properly tightened Check for any damage to the housing Verify that the 4 1 4 20 x 1 1 2 screws mounting the pump are tight and set to a torque of 120 5 lbs Also ensure that the pump constraint covers on the bottom of the control module are properly seated and torque is set to 14 1 in lbs Check that the pump muffler is properly oriented and set to correct torque Replace the pump See Chapter 4 Adjust the screen using the screen handle located behind the screen Replace the locking pin Rotate the screen in the opposite direction Replace the top cover Press down on the locking tab of the vacuum set cartridge and pull out to remove from the control module 3l MAMMOTOME Biopsy System Service Manual Symptom The remote keypad does not respond when the buttons are pressed The footswitch does not respond when the foot pedals are pressed Support arm moves when the holster cables are adjusted Con
96. software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Reinstall software See Software Installation Guide Replace uniboard PCB assembly See Chapter 4 Cycle system power Perform Internal Encoder Test If test fails see Hardware Checks in this chapter Cycle system power Perform Internal Encoder Test If test fails see Hardware Checks in this chapter Error Code L4 025 L4 026 L4 027 L4 028 L4 029 L4 030 L4 031 L4 032 L4 033 L4 034 Error Message POST ERROR RAM Failure POST ERROR CPLD Failure POST ERROR ID Chip Failure Programming Checksum Error Programming Block Sequence Compromised Programming Aborted Prematurely Translation Motor F
97. sor ratio is 150 mV per PSI which is equivalent to 73 674 mV per inches of Hg To determine inches of Hg subtract the offset value from the ADC reading Multiply the resulting decimal value by 19 53 Divide that result by 73 764 The result is the vacuum level in inches of Hg Internal Motor Control System One motor drives the cutter rotation and another motor drives the cutter translation The translational motor controller can receive its feedback either from the encoder in the holster or the encoder attached to the motor itself The rotational motor controller receives its feedback from the encoder attached to the motor itself Internal Motor Drivers The uniboard contains two motor drivers one for the translational motor and one for the rotational motor The rotational motor drive can be controlled closed loop or open loop In the closed loop case the motor driver is controlled with the motor controller by a PWM signal via feedback from one of the encoders attached to the mechanical shaft In the open loop case the rotational motor controller is bypassed and a PWM signal generated by the PLD is sent to the rotational motor driver without encoder feedback External Motor Control System An additional motor control system controls both the cutter translation and rotation through motors attached externally to the control module Both motors are controlled through a state model which provides a time based sequence for control of b
98. sse 103 Upgrade Procedure uei s inen rx e RR seis CAD ROTE ale 8 RCRXARCY RUE ARR e 103 Upgrading Control Modules SCMI2 and SCM23 for EX Functionality 104 Inspection Criteria 1 eoe m p epe dono p Rp e ale RR ARRIANS 104 Materials Equipment Required csse ees 104 Upgrade Procedure uestre ty Pre OE Te YER RU LER E Pen 104 MAMMOTOME EX Identification 2 65 s0c0 0s cee esa Rm ehe eeu caves REFERRE 108 MR Cart Upgrade Kit 5h UH weenie ne bee eee ue eee RO Ra 109 Inspection Criteria 1 see a ee t e NR eet Ro arene RR ea e 109 Assembly Instructions reir ed eame de RP des Gans pe Ee RR Ede 109 Chapter 6 Electrical Safety Testing cece nee eae 113 litroduction esecerrkes exu pRREepbREE Re Xv ER RA RES UY RP E Ere RR Rede sus 113 Required Equipment 1 5 tti entres CS RR RR dangle Rok eo a ean dine 113 Electrical Safety Tests c 0cca satin be itn b eee REY ERR ee eee CRY re Ie a eee 113 Mains to Earth Ground Test Procedure iis 113 Mains to Patient Test Procedure icis es 113 Ground Continuity Test ccc cccg0tise reper peda we Peewee ge ERR X ERU 113 Chapter 7 Warranty ecciesie losses bebe eee eee ee Sa oe ee eae A Re 115 Table of Contents continued This manual is subject to revision Ethicon is a trademark of Ethicon Inc Lebowe is a registered trademark of Lebow Associates Inc McMaster Carre is a registered trademark of McMaster Carr Supply Company Loct
99. sse 68 Replacing the Rotation Motor Drive Shaft isis 69 Replacing the Rear DC Motor Translation or Sprocket lseeeeeelelslsss 69 Replacing the Drive Shafts Bushings Chains and Sprockets 0 000 eee ee 70 MR Holster Repair and Replacement Procedures 00 e cee eee eee eese 72 Table of Contents continued Replacing the Remote Keypad ccc cee e eee etc teen ene e eee ene 72 Removing the Top housing from the Bottom Housing 0 eee eee eee 73 Removing the Lens PCB Assembly from the Top Housing 2 eee eee 73 Removing the Holster Bottom from the Gearbox Tongue 00 00 eee 74 Removingn the Cable and Strain Relief from the Gearbox Tongue Assembly 74 Removingn the Input Gears and Cover 75 Removing the Encoder from the Gearbox Tongue Assembly ee cece 75 Replacing the Thumbwheel Shaft and Gear 76 Servicing the Gearbox Assembly sssseee eet e een e een ees 76 Removing the Electrical Cable with the Lemo Connectors 000s eee e eee eens 78 Removing the HIB Enclosure sse 78 Removing the HIB PCB esc cett ca een ed Rhe eo Re Ee oa e Re 78 Removing or Replacing the Drive Cable 0 eect teens 79 Support Arm Repair and Replacement Procedure 0 cee eee eee eee eee eee 79 Cart Assembly Repair and Replacement Procedures 00 e cece eee eens 80 Replacing the Car
100. stem DRAM The system DRAM consists of two 2 4 Mb x 16 components The CPU performs 5 clock cycle reads and 5 clock cycle writes A column row address strobe and write enable are the control signals for the system DRAM Touchscreen Controller The touchscreen controller is a PIC microcontroller running at 4 MHz that communicates with the main microcontroller through a UART Digital to Analog Converter There are two digital to analog converters DACs a parallel DAC and a IC ADC DAC The parallel DAC is used in the following manner DACA sets the backlight brightness level DACB sets the translational motor current limit threshold DACC sets the rotational motor current limit threshold Chapter 2 Theory of Operation Component Size Organization Speed ns EPROM 512 Kbyte 256K x 16 150 System Flash 8 Mb expandable to 16M 4 2M x 8 2M x 32 90 e System DRAM 15 Mb 2 4M x 16 4M x 32 50 Analog to Digital Converter The IC ADC DAC is a Philips PCF8921AT The C address is equal to 0 A2 0 A 0 AO 1 The IC ADC DAC is used for the following DAC sets the vacuum system regulation value ADCO reads the vacuum pressure value ADC1 is a spare ADC 2 reads the translational motor current ADC3 reads the rotational motor current Temperature Sensor The temperature sensor is a National LM75CIM 5 I2C device The I2C address is equal to 1 A2 0 Al 20 AO 1 LCD and Remot
101. structions in this chapter Requirement 85 MAMMOTOME Biopsy System Service Manual EX Upgrade See EX Upgrade See EX On request instructions in this chapter Upgrade instructions in this chapter MR Cart Upgrade See MR Cart Upgrade instructions See MR Cart Upgrade MR system in this chapter instructions in this chapter installation Note Upgrade requirements are defined as follows As Needed This upgrade should only be performed if the affected part or assembly has failed Upon Request This upgrade should only be performed if specifically requested by the customer Mandatory This upgrade must be performed if the unit is not already in the upgraded configuration The following upgrades should be inspected for and performed as required on the Stereotactic Holster STHC1 Part Assembly Original Condition Upgrade to Requirement Rear Thumbwheel Assembly See Replacing the ST Holster Rotation Mandatory Knob instructions in this chapter Spade and Coupling Assembly See Replacing the ST Holster Rotation Mandatory instructions in this chapter Coil Pin Replacement See Coil Pin Replacement instructions Mandatory in this chapter 86 Chapter 5 System Upgrades Ground Wire Installation Inspection Criteria Units in need of this upgrade will have an 8 32 x 1 2 long screw running down through the chassis fastening two ring terminals The ground screw is located in the rear of the unit as dep
102. sy System Service Manual How Supplied The MAMMOTOME Holster MAMMOTOME Control Module with SMARTV AC MAMMOTOME Footswitch MAMMOTOME Support Arm MAMMOTOME Cart MAMMOTOME Remote Keypad and MAMMOTOME Software Package are supplied non sterile Dispose of these devices and all accessories in accordance with applicable local regulations For information on material content contact Ethicon Endo Surgery Inc Safety Information Warnings and Precautions Warning Risk of Fire e Replace fuses as marked Refer to Chapter 4 Repair and Replacement Procedures for fuse specifications and location Warning Electric Shock Hazard Always disconnect the device from the electrical power source before cleaning or servicing High voltages may be present on surfaces inside the control module Never touch an exposed conductive surface while the cover is removed and the unit is energized Caution ESD Sensitive Components The MAMMOTOME Biopsy System contains components that are sensitive to electrostatic discharge ESD Proper ESD precautions must be taken while servicing the MAMMOTOME Biopsy System A grounded wrist strap must be worn at all times Repair work must be done at a static controlled workstation Use an antistatic container for the transport of ESD sensitive circuit boards and components Caution Servicing by Qualified Personnel Only To reduce the risk of electric shock do not remove protective housing Servicing sh
103. t Handle 2 3605 d6 cece eda eabe eked nea POE eee esas 8l Replacing or Relocating the Holster Receptacle and Bracket 0 000s ee aee 8l Replacing the Power Cord Wrap Posts 0 0 cece cece cee eee 82 Replacing a COSC ii os ope PROC ENSE RUE DIM EE et i Ein 82 Replacing the Cart Door Latch 1 1 0 cece e 83 Replacing the Cart Door and Hinges 0 0 ccc ee 83 Replacing the Pull Out Drawer Guides ciliis 83 Replacing the Fastener Plate cicccccc nite ct nen tees chee re re Reb ee ee a 84 Chapter 5 System Upgrades 0 ec ccc nee een e 85 Introduction socer Subp dag Ges EErEE Re buona car ere rd eee ERU CES PER Eb dieu eoi 85 Ground Wire Installation 5 3 erret UR oO Rent Ret ke Rn Fond aca AR Rete e ea 87 Inspection Criteria i c ee a er x ee Rete S dee SES eee nee RUE 87 Upgrade Instructions 2 0005 eee erre Rr esee eee TOS EER eed 87 Wniboard Upgrade 5 2 hber Ete bbp e ect p hd Rat x eae eacus 88 Inspection Criterid 2 secs rre ERR Re rex DE oye RES HC RR 88 Material Equipment Required ccce 88 Upgrade Instr ctiohs 5 1 a Ave sept ete arbre ck IE VR RAS HEY Ra NE EHE RC 88 Routing of Pump Wiring ose set ot gr nh ERE E e wae Ro ne dese ie eai e 89 Inspection Criteria i d serere E EERE EEEE TP CEPP OE RUE 89 Material Equipment Required ccce ne 89 Upgrade instructions ais oreet erT Enn ESERSE RESTER RARE E ER 89 Change in Vacuum Pump and Components 00 c eee
104. t assembly follow steps 9a through 9f Figure 4 11 Replacing the LCD Front Assembly Tie strap Re e T Thumbscrew Il e Figure 4 11 Replacing the LCD Front Assembly G 51 MAMMOTOME Biopsy System Service Manual 52 12 13 14 15 16 17 18 19 20 21 22 23 a Loosen the thumbscrews and disconnect the two LCD cables from the PCB b Remove the fastener and star washer securing the ground cable c Cut the two tie straps securing the LCD cables Caution Do Not cut the cable jacket d Remove the cables e Secure the LCD cables to the new LCD front assembly with two new tie straps f Remountthe ground wire g Reinstall the LCD cables so that the thicker cable is at J1 of the PCB and the thin cable is at J6 h Tighten the thumbscrews Make sure that the speaker is properly mounted and the speaker wires pass through the wire holder or channel on the rear housing of the LCD Gently press the two halves together pulling excess wires through as they come together Make sure that the rubber tube does not pinch between the halves Secure with the seven 7 phillips head fasteners previously removed Clean the areas around the two fasteners flanking the speaker grille Cover the fasteners with new adhesive dots Reconnect the ferrite bead to the thick LCD cable near the opening of the rubber resistance fingers Reinstall the two 3 16 standoffs
105. t secure the uniboard bracket to the chassis 2 Remove the remaining nine 9 wire harnesses and cable assemblies connected to the uniboard PCB assembly 3 With even force remove the tubing from the vacuum sensor of the uniboard PCB assembly 4 Carefully slide the uniboard PCB assembly and bracket from the lower rear corner connector Figure 4 13 Replacing the Uniboard PCB Assembly Uniboard PCB assembly Bracket Corner connector Figure 4 13 Replacing the Uniboard PCB Assembly 53 MAMMOTOME Biopsy System Service Manual 5 Remove the eight 8 phillips head fasteners that secure the uniboard to the bracket 6 Replace the uniboard PCB assembly and secure it to the bracket with the eight 8 fasteners 7 At the lower rear corner of the uniboard PCB assembly carefully connect the assembly to the connector PCB Reconnect all wire harnesses Reattach the vacuum tubing to the bottom fitting of the vacuum sensor Caution Apply force in a straight even motion moving the tubing back and forth onto the sensor may cause the fitting to break 10 Secure the bracket to the chassis with the four 4 fasteners Note Do Not replace the rearmost fastener this location will be required to fasten the ground wire from the LCD assembly when the top cover is replaced Replacing the Interface Board Assembly I Remove the two 2 wiring harnesses and one 1 power cab
106. talling the Bracket and Docking Cup Assemblies Note There are only two 2 saddle assembly mounting blocks Install the MR bracket and docking cup assembly in one mounting block install the EX HH or ST docking cup and bracket assemblies in the other mounting block Store the remaining docking cup and bracket assembly for future use Mount the tube set hanger to the top of the cart door Mount the two 2 MR Unsafe labels one on the front of the control module and one on the front of the cart See Figure 5 36 and Figure 5 37 for MR Unsafe label placement locations MR bracket and docking cup assembly Mounting block Tube set hange MR Unsafe labe Figure 5 36 Installing the Bracket and Docking Figure 5 37 MR Unsafe label Placement Cup Assemblies Location on Control Module MAMMOTOME Biopsy System Service Manual 112 Introduction Chapter 6 Electrical Safety Testing Electrical safety testing is required whenever the ground is disconnected from the MAMMOTOME System and or an electrical mechanical component is removed or replaced Required Equipment Dielectric Strength Tester Continuity Tester Electrical Safety Tests Mains to Earth Ground Test Procedure 4 5 Connect the High Voltage port of the tester to the mains of the unit under test Connect the Return port of the tester to the ground lug of the unit under test Set the tester to 1200AC volts 1834 VAC for SCM23 for one second with a one second
107. te Shield Clip on plastic shrouded 1 D15356 Mammotome EX Label 1 UpgradeProcedure I Remove the main housing from the control module 2 Observe the orientation of the capacitor bracket refer to Figure 5 22 for correct orientation If the bracket is not oriented properly remove the two fasteners securing the bracket rotate the bracket and resecure the bracket 3 Remove the front left lock nut which secures the rubber feet to the base plate lock nut closest to the capacitor bracket See Figure 5 22 Capacitor and Base Plate View Front Interface Bracket fastener Capacitor Bracket Orientation Left Lock Nut Figure 5 22 Capacitor and Base Plate View 104 uk Chapter 5 System Upgrades Remove the fastener on the front interface bracket Disconnect holster interface harness from uniboard and remove tie strap securing motor wire harnesses to holster interface harness See Figure 5 23 Holster Interface Harness Identification for identification of correct harness Uniboard connection for Holster Interface Harness Tie Strap Holster Interface Harness Figure 5 23 Holster Interface Harness Identification Attach a ferrite bead p n 28A0640 0A0 to the end of the holster interface harness See Figure 5 24 Ferrite Bead Location Ferrite Bead Holster Interface Harness Figure 5 24 Ferrite Bead Location Connect the uniboard interface harness p n 3432 407 to the uniboard and route over the top of
108. tem Service Manual Error Code L3 019 L3 020 L3 021 L3 022 L3 023 24 Error Message Inadequate Airflow through Unit Adjust Blue Holster Cable Probe Damaged Vacuum Tubing Connections Pre Fire Position Remote Keypad Disconnected Probable Cause Airflow through control module is restricted beneath or at the back panel of the control module Excessive bending of blue drive cable Multiple causes Vacuum set connection is loose or disconnected Probe has not been fired Remote keypad is not properly connected to control module User no longer wants to use remote keypad Corrective Action Remove restrictive material s from beneath or behind the control module Allow sufficient time to cool Ensure the control module is at least 6 15 24 cm from all walls Press to continue Straighten blue drive cable Press to continue Reload probe or load new probe as described in probe package insert Press to continue Check the following vacuum connections for tightness Flexible tube connections at canister lid Vacuum set cartridge connection Canister lid Press to continue Release safety lever and press to continue Press the fire button on the ST holster Properly seat remote keypad connector in back panel of the control module Press to continue 1 Switch off O the control module 2 Disconnect the remote keypad from the control
109. ter Figure 4 57 Replacing a Caster Replacing the Cart Door Latch l 2 5 Open the cart door Remove the female portion of the latch from the door back panel by loosening and removing the two phillips head fasteners Replace the female portion of the latch securing it with two phillips head fasteners Note Apply a drop of Loctitee 242 on the threads of each fastener before securing the latch Remove the latch bracket from the left wall weldment by loosening and removing the two phillips head fasteners Replace the latch bracket securing the two 2 phillips head fasteners Replacing the Cart Door and Hinges l 2 3 4 5 6 7 Open the cart door While steadying the cart door remove the four 4 phillips head fasteners two for each hinge securing the door hinges to the side of the cart Remove the cart door Remove the remaining phillips head fasteners securing the hinges to the door Remove the hinges from the door Replace the hinges securing them first to the door Fasten the door to the cart by securing the other side of the hinges with phillips head fasteners Replacing the Pull Out Drawer Guides l 2 Open the cart door Remove the pull out drawer by pressing the black release levers on the side of the drawer and removing the drawer from the guides Figure 4 58 Replacing the Pull Out Drawer Guides Loosen and remove the three 3 phillips head fasteners that secure each guid
110. the seven 7 phillips head fasteners from the back of the gray housing Note Two fasteners are hidden under gray adhesive dots Remove and discard the dots before removing the fasteners 7 Remove the white ferrite bead clamped on the larger LCD cable This frees the LCD cables and allows the LCD front assembly to move more freely Figure 4 9 Freeing the LCD Cables White ferrite bead Figure 4 9 Freeing the LCD Cables 50 Chapter 4 Repair and Replacement Procedures 8 If it is necessary to replace the U bracket follow steps 8a through 8f a Remove the two 2 phillips head fasteners securing the U bracket in place Figure 4 10 Replacing the U Bracket p l Two 2 phillips head fasteners l Handle spring O U bracket Figure 4 10 Replacing the U Bracket b Separate the U bracket rear LCD housing and handle Note The handle is held in place by a release spring c Place one pin of the new U bracket into the pivot hole of the rear housing Flex the other end of the U bracket just enough to slide the other pin into place d Place the U bracket between the guide ribs e Secure the U bracket handle using the two fasteners previously removed f Compress the handle spring and insert into the handle 9 If it is necessary to replace the LCD fron
111. to continue MAMMOTOME Biopsy System Service Manual Error Code L3 004 L3 005 L3 006 L3 007 L3 008 L3 009 22 Error Message Adjust Green Holster Cable Probe Damaged Adjust Blue Holster Cable Probe Damaged Vacuum Tubing Connections Black Holster Cable Disconnected Footswitch Disconnected Green Holster Cable Probe Damaged Probable Cause Excessive bending of green drive cable Multiple causes Excessive bending of blue drive cable Multiple causes Vacuum set connection is loose or disconnected Black electrical cable connector on holster is not properly connected to control module Footswitch is not properly connected to control module User no longer wants to use footswitch Green drive cable connector is not properly connected to control module Green drive cable connected to blue cable connector port Excessive bending of green drive cable Multiple causes Corrective Action Straighten green drive cable Press to continue Unload damaged probe and load new probe as described in probe package insert Press to continue Straighten blue drive cable Press to continue Reload probe or load new probe as described in probe package insert Press the EXIT button to reinitialize the probe Check the following vacuum connections for tightness Flexible tube connections at canister lid e Vacuum set cartridge connection e Canister
112. top motor mount Figure 4 38 Replacing the Rotation Motor Drive Shaft Anti rotation tab Figure 4 38 Replacing the Rotation Motor Drive Shaft Replacing the Rear DC Motor Translation or Sprocket Note The translation motor p n D13393P01 02 is larger than the rotation motor p n D13392P01 02 I Remove the two 2 fasteners securing the top motor mount cover in place remove cover 2 Remove the loose hex nut that attaches the power cord assembly 3 Tilt the back of the translation drive shaft up and slide the drive chain from the motor sprocket 4 Loosen the two 2 fasteners in the front of the motor 5 Disconnect the motor connector from the flex circuit assembly 6 Remove the motor from the mounting brackets Figure 4 39 Replacing the Rear DC Motor Translation or Sprocket Mounting brackets Figure 4 39 Replacing the Rear DC Motor Translation or Sprocket 69 MAMMOTOME Biopsy System Service Manual 7 Remove the coil pin from the sprocket 8 Replace the motor or sprocket and press in a new coil pin 9 To reinstall the motor reverse the above procedure Replacing the Drive Shafts Bushings Chains and Sprockets l Remove the power cable and the bottom housing 2 Lift up the flex circuit board to expose the phillips head fasteners 3 Remove the two 2 fasteners holding the top motor mount cover remove the cover 4 Tilt the drive shafts upward at the rear and remove the drive chains 5 Remove the driv
113. trol module To view the Usage Log press the Next button on the Event Log Review screen Chapter 3 Troubleshooting USAGE LOG REVIEW Control module data Usage Log Reset 00 00 2000 165 00 80 Event Log Reset 00 00 1999 00 00 00 Unit On Timo 33 hrs 34 min 50 seo Vacuum On Time 5 hes 36 min 50 seo Connected holster data Back button Translation Cycles 50331 Rotation Cycles 0 Next button we er Figure 3 9 Usage Log Review Screen To return to the Event Log Review screen press the Back button on the Usage Log Review screen To return to the User Selection screen press the Next button on the Usage Log Review screen Copying the Event and Usage Logs to a Memory Card To copy the Event and Usage Logs to a standard PCMCIA card l Select the Copy Event and Usage Logs button at the Event Log Review screen 2 Insert a blank PCMCIA card into the back panel of the control module when you see the Copy Event and Usage Logs pop up screen 5 EVENT LOG REVIEW BONAR ni n9 nn na n amp kdonna 92 6 05 Bowne On v9 5 gt Copy Event and Usage Logs pop up screen Next button Copy Event and Usage Logs button Figure 3 10 Copy Event and Usage Logs Pop up Screen 3 Press the Next button on the Copy Event and Usage Logs pop up screen to copy the Event and Usage Logs to the PCMCIA card 41 42 MAMMOTOME Biopsy System Service Manual 4 When copying is complete press the Next
114. up screen Insert the blank PCMCIA card in the control module when the Copy Event and Usage Logs pop up screen appears e Press the Next button to copy the Event and Usage Logs to the PCMCIA card To erase the information on the PCMCIA card and copy the Event and Usage Logs to the PCMCIA card press the Next button on the pop up screen shown above If copying the Event and Usage Logs to a PCMCIA card could not be completed the following pop up screen appears on the display Cj EVENT LOG REVIEW Boason ni n NN nn o 9nnd 11 40 37 Panwar An fe Ons Upload failed Figure 3 14 Copy Event and Usage Logs Pop up Screen Upload failed e Press the Forward button on the message pop up screen Reinsert or replace the PCMCIA card when the Copy Event and Usage Logs pop up screen appears on the display 43 MAMMOTOME Biopsy System Service Manual Press the Next button on the Copy Event and Usage Logs pop up screen to copy the Event and Usage Logs to the PCMCIA card EVENT LOG REVIEW Banaan Ht NI AN na nA 9004 19 1605 Power An wont Copy Event and Usage Logs pop up screen Next button Copy Event and Usage Logs button Figure 3 15 Copy Event and Usage Logs Pop up Screen 44 Chapter 4 Repair and Replacement Procedures Introduction Chapter 4 Repair and Replacement Procedures describes how to repair and replace various components of the control module and cart ST holster and support arm
115. upplied with the cart Remove the bracket Remove the holster receptacle from the bracket only necessary if the holster receptacle will not be replaced by removing the two 4 40 button socket head cap screws with the 1 16 allen wrench supplied with the cart Place the receptacle bracket into the slot on either side of the cart near the top surface Note The cart has studs to accept the slotted holes in the bracket The bracket must be tipped at an upward angle and placed through the slot in order to clear the bottom of the studs Tighten the two 2 4410 32 flange nuts with the 3 8 box wrench Place the new holster receptacle on the receptacle bracket Fasten the holster receptacle to the bracket with the two 2 4 40 button socket head cap screws and 1 16 allen wrench Note Do Not overtighten 8l MAMMOTOME Biopsy System Service Manual 82 WT 1 16 Allen wrench M 4 40 Button socket 3 head cap screw Holster receptacle Figure 4 56 Replacing or Relocating the Holster Receptacle and Bracket Replacing the Power Cord Wrap Posts I 2 3 4 Remove the power cord from the wrap posts Remove the allen head fastener inside the damaged post s Remove the damaged post s Install the new post s Replacing a Caster ou AR Ww M 12 13 Remove power from the control module Disconnect the holster from the control module Remove the holster from the holster receptacle and st
116. y if The person installing the device ensures that the installation inspection and any required testing are performed in accordance with the instructions in this manual The inspection shall be documented along with any test results to demonstrate proper installation Persons authorized by Ethicon Endo Surgery Inc carry out any and all service repair and upgrade operations The equipment is used in accordance with the MAMMOTOME System Operator s Manual the MAMMOTOME EX Biopsy System Operator s Manual and the MAMMOTOME MR Biopsy System Operator s Manual Warning Removing the tamper evident label on the underside of the control module invalidates any warranty provided by Ethicon Endo Surgery Calling for Service Call 1 800 USE ENDO U S calls or 1 513 337 8901 International calls English speaking only or contact your local representative Customer support is also available at customersupport eesus jnj com Additional Product Information For a complete listing and description of available products fo r use with the MAMMOTOME Biopsy System visit the following website www breastcareinfo com System Specifications Classifications Type CF Applied Part e Class 1 Mode of Operation Intermittent operation with a duty cycle of 45 min ON and 15 min OFF Safety Medical Equipment o With respect to electric shock fire and mechanical hazards only in accordance with C US UL60601 1 IEC60601
117. y of older vacuum pumps will be depleted prior to transitioning to the new pump pumps can be distinguished by the model number labeled on the pump older pumps are labeled with model number K48ZZDZH3250 for 115V and 2639 VGH44 3374 for 230V Inventory of the old fastener p n 700 001529 will be scrapped and replaced with the new fastener p n 3432 367 The fastener of length 1 1 2 p n 700 001529 and p n 3432 367 is only for use with the older vacuum pump Due to a height increase with the new pump this longer fastener has a possibility of extending through the base of the casting and contacting the pump Procedures for Installing New Pump and Components I Remove old pump according to the instructions in Chapter 4 of this manual 2 Place the new pump new pump can be identified by the model number located on the pump 2669 VES44 337 for 115V or 2669VGH 144 337 for 230V over the mounting pads ensuring that the intake port is the closest port to the uniboard 3 Insert the stem of the rubber isolation mount p n 700 001500 into the bottom of the base plate and align with the base of the pump 4 Cover isolation mount with the existing pump constraint 3432 087 and temporarily secure both the pump constraint and the isolation mount to the chassis with two 6 32 x 1 1 8 Phillips flat head screws p n 700 001576 This step will help to hold both the isolation mount and pump constraint in place until secured in a later step 5 Place a sm

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