Mammotome® Biopsy System

Mammotome® Biopsy System
Mammotome® Biopsy System
Service Manual
Table of Contents
Chapter 1 - System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Calling for Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Additional Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Shipping and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Equipment Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Electromagnetic Compatibility (EMC), Guidance, and Manufacturer Declarations . . . . . . . . . 2
How Supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Safety Information / Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Warning - Risk of Fire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Warning - Electric Shock Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Caution - ESD Sensitive Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Caution - Servicing by Qualified Personnel Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
System Component Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Cart and MR Cart Upgrade and Holster Spool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Control Module and Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
ST Holster and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
ST Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
HH Holster and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
HH Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
EX Holster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
EX Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Remote Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
MR Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
MR Holster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
MR Targeting Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
MR Interlock System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Chapter 2 - Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electrical System Design Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
System Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Uniboard/Interface Board Interface at Interface Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Interface Board/EX Holster Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Interface Board/ST and HH Holster Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Interface Board/MR Holster Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Uniboard/Connector Board Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Uniboard/LCD Board Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Uniboard Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
MAMMOTOME Biopsy System Service Manual
Table of Contents continued
Chapter 3 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Level 1 Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Level 2 Attention Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Level 3 Attention Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Level 4 Attention Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Hardware Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
L3 Attention Screens for MR Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
System Checks for MR Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Targeting Set Troubleshooting for MR Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Event and Usage Log Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Copying the Event and Usage Logs to a Memory Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Chapter 4 - Repair and Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Control Module Repair and Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Removing the Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Replacing the Flexible Vacuum Source Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Location and Specification of Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Replacing the LCD Assembly Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Replacing the Uniboard PCB Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Replacing the Interface Board Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Replacing the Vacuum Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Replacing the Translational and Rotational Motors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Replacing the Solenoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
ST Holster Repair and Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Disassembling the Holster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Replacing the Cable Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Replacing the Encoder Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Replacing the Mounting Bracket Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Replacing the PCB Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Replacing the Firing Mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Replacing the Safety Mechanism Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Reassembling the Holster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
EX Holster Repair and Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Replacing the Power Cord Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Replacing the Bottom Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Replacing the Top Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Replacing the Keypad Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Replacing the Flex Circuit Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Replacing the Front DC Motor (Rotation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Replacing the Rotation Motor Extension Shaft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Replacing the Rotation Motor Drive Shaft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Replacing the Rear DC Motor (Translation) or Sprocket . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Replacing the Drive Shafts, Bushings, Chains and Sprockets . . . . . . . . . . . . . . . . . . . . . . . . . 70
MR Holster Repair and Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Table of Contents continued
Replacing the Remote Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Removing the Top housing from the Bottom Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Removing the Lens PCB Assembly from the Top Housing . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Removing the Holster Bottom from the Gearbox Tongue . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . 75
Replacing the Thumbwheel Shaft and Gear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Servicing the Gearbox Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Removing the Electrical Cable with the Lemo Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Removing the HIB Enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Removing the HIB PCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Removing or Replacing the Drive Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Support Arm Repair and Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Cart Assembly Repair and Replacement Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Replacing the Cart Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Replacing or Relocating the Holster Receptacle and Bracket . . . . . . . . . . . . . . . . . . . . . . . 81
Replacing the Power Cord Wrap Posts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Replacing a Caster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Replacing the Cart Door Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Replacing the Cart Door and Hinges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Replacing the Pull-Out Drawer Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Replacing the Fastener Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Chapter 5 - System Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Ground Wire Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Upgrade Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Uniboard Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Material/Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Upgrade Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Routing of Pump Wiring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Material/Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Upgrade Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Change in Vacuum Pump and Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Description of Changes in the Isolation Mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Description of Changes in the Pump Mount Screws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Disposition of Old Vacuum Pump and Related Components . . . . . . . . . . . . . . . . . . . . . . . . 91
Procedures for Installing New Pump and Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Vacuum Tubing Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
MAMMOTOME Biopsy System Service Manual
Table of Contents continued
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Upgrade Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Replacing the ST Holster Rotation Knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Coil Pin Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Materials/Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Inspection Criteria/Upgrade Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Upgrade Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
DC Motor Adapter Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Materials/Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Upgrade Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Upgrading Regulatory Label on Control Modules SCM12 and SCM23 . . . . . . . . . . . . . . . . . . .103
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Materials/Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Upgrade Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Upgrading Control Modules SCM12 and SCM23 for EX Functionality . . . . . . . . . . . . . . . . . . .104
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Materials/Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Upgrade Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
MAMMOTOME EX Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108
MR Cart Upgrade Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Inspection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Assembly Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Chapter 6 - Electrical Safety Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113
Electrical Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Mains to Earth Ground Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Mains to Patient Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Ground Continuity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Chapter 7 - Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Table of Contents continued
This manual is subject to revision.
Ethicon is a trademark of Ethicon, Inc. Lebow ® is a registered trademark of Lebow Associates, Inc. McMaster-Carr® is a
registered trademark of McMaster-Carr Supply Company. Loctite® and Loctite 242® are registered trademarks of the Loctite
Corporation. DuPont Krytox® is a registered trademark of the DuPont Company. Dow Corning® is a registered trademark of the
Dow Corning Corporation. Windows® is a registered trademark of Microsoft Corp. i486® is a registered trademark of Intel Corp.
Adobe® and Acrobat® 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)
[email protected]
MAMMOTOME Biopsy System Service Manual
Chapter 1 - 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 only 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 [email protected]
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
•
Class 1
•
Mode of Operation: Intermittent operation with a duty cycle of 45 min. “ON” and 15 min. “OFF.
•
Safety:
Medical Equipment
With respect to electric shock, fire and mechanical hazards only in accordance with
UL60601-1, IEC60601-1, CAN/CSAC22.2 No. 601.1, EN 60601-1,
and IEC 60601-1-2.
Shipping and Storage
•
Temperature: -35ºC to +54ºC
•
Humidity: 10% to 100% Relative Humidity, Non-Condensing
•
Atmospheric Pressure: 500 hPa to 1,060 hPa
Equipment Operating Conditions
•
Temperature: +5ºC to +40ºC
•
Humidity: 30% to 75% Relative Humidity, Non-Condensing
•
Atmospheric Pressure: 700 hPa to 1,060 hPa
1
MAMMOTOME Biopsy System Service Manual
Electrical Specifications
Specification
SCM12
SCM23
Operating Voltage
120V~
220/240V~
Operating Current
6.3 Amps (Maximum)
3 Amps (Maximum)
Operating Frequency
60 Hz
50/60 Hz
Agency Compliance
CF
CF
Patient Isolation (Protection
Against Electrical Shock)
USA: UL60601-1
Europe: IEC60601-1, IEC60601-1-2,
IEC60601-1-4
Canada: CSA C22.2 No. 601.1
USA: UL60601-1
Europe: IEC60601-1, IEC60601-1-2,
IEC60601-1-4
Canada: CSA C22.2 No. 601.1
Operating Temperature
5˚C - 40˚C (41˚F - 104˚F)
5˚C - 40˚C (41˚F - 104˚F)
Operating Humidity
30% to 75% Relative Humidity, Non-Condensing
Operating Duty Cycle
45 Minutes On, 15 Minutes Off
45 Minutes On, 15 Minutes Off
Fuse Ratings
See Chapter 4 Repair and
Replacement Procedures.
See Chapter 4 Repair and
Replacement Procedures.
Degree of Protection
Against Ingress of Fluids
System: IPX0
Footswitch: IP68
System: IPX0
Footswitch: IP68
Electromagnetic Compatibility (EMC), Guidance, and Manufacturer 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
2
Emissions Test
Compliance
Guidance
RF Emissions CISPR 11
Group 1
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
Class A
The MAMMOTOME Biopsy System is suitable for
use in establishments other than domestic and those
directly connected to public low-voltage power
supply networks.
Harmonic Emissions IEC
61000-3-2
NA
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
NA
Chapter 1 - System Overview
Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Guidance
Electrostatic
Discharge
IEC 61000-4-2
± 6kV Contact
± 8kV Air
± 6kV Contact
± 8kV Air
Relative humidity should be at
least 30%.
Radiated RF
IEC 61000-4-3
3 Vrms
80 MHz to 2.5 GHz
Portable and mobile RF
communications equipment (cell
phones) should not be used at
close distances.
Electrical fast
Transient/Burst
IEC 61000-4-4
± 2kV on Power
Supply Lines
± 2kV on Power
Supply Lines
Mains power quality should be
that of a typical commercial or
hospital environment.
± 1kV on
Input/Output Lines
± 1kV on
Input/Output Lines
± 1kV Differential
Mode
± 1kV Differential
Mode
± 2kV Common
Mode
± 2kV Common
Mode
3 Vrms from 150
kHz to 80 MHz
3 Vrms from 150
kHz to 80 MHz
10 Vrms from 80
MHz to 2.5 GHz
10 Vrms from 80
MHz to 2.5 GHz
PowerFrequency
Magnetic Fields
IEC 61000-4-3
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Voltage Dips,
Short Interrupts,
and Variations on
Power Supply
Lines
IEC 61000-4-11
<5% UT (95% dip in
UT for 0.5 cycles)
<5% UT (95% dip in
UT for 0.5 cycles)
<40% UT (60% dip
in UT for 5 cycles)
<40% UT (60% dip
in UT for 5 cycles)
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
<70% UT (30% dip
in UT for 25 cycles)
<70% UT (30% dip
in UT for 25 cycles)
Surge
IEC 61000-4-5
Conducted RF
IEC 61000-4-6
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.
3
MAMMOTOME Biopsy System Service Manual
How Supplied
The MAMMOTOME Holster, MAMMOTOME Control Module with SMARTVAC ®, 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 EndoSurgery, Inc.
Safety Information/Warnings and Precautions
Warning - Risk of Fire
•
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
•
4
To reduce the risk of electric shock, do not remove protective housing. Servicing should be
performed by qualified personnel only.
Chapter 1 - System Overview
System Component Dimensions
Component
Weight
Size Dimensions
Cart
104 lbs. (47.2 kg)
See Figure 1-1. Cart Dimensions
Cart with MR Upgrade and
Holster Spool
180.5 lbs. (81.8 kg)
See Figure 1-1. Cart Dimensions
Control Module and Screen
58 lbs. (26.3 kg)
See Figure 1-2. Control Module/Screen Dimensions
ST Holster and Cables
2.3 lbs. (1.0 kg)
See Figure 1-3. ST Holster and Cables Dimensions
ST Probe
.34 lbs. (.16 kg)
See Figure 1-4. ST Probe Dimensions
HH Holster
1.6 lbs. (738 g)
See Figure 1-5. HH Holster Dimensions
HH Probe
.24 lbs. (110 g)
See Figure 1-6. HH Probe Dimensions
EX Holster
.56 lbs. (255 g)
See Figure 1-7. EX Holster Dimensions
EX Probe
.28 lbs. (128 g)
See Figure 1-8. EX Probe Dimensions
Footswitch
3.8 lbs. (1.7 kg)
See Figure 1-9. Footswitch Dimensions
Remote Keypad
.24 lbs. (.11 kg)
See Figure 1-10. Remote Keypad Dimensions
MR Probe
.32 lbs. (146 g)
See Figure 1-11. MR Probe Dimensions
MR Holster
4.0 lbs. (1.8 kg)
See Figure 1-12. MR Holster Dimensions
MR Targeting Set
.16 lbs. (.07 kg)
See Figure 1-13. MR Targeting Set Dimensions
MR Interlock System
.55 lbs. (.25 kg)
See Figure 1-14. MR Interlock System Dimensions
Cart and MR Cart Upgrade and Holster Spool
32.5"
(82.5 cm)
18.3"
(46.5 cm)
13.9"
(35.5 cm)
18.0"
(45.7 cm)
24.8"
(62.9 cm)
Figure 1-1. Cart Dimensions
5
MAMMOTOME Biopsy System Service Manual
Control Module and Screen
8.8"
(22.2 cm)
8.4"
(21.3 cm)
9.0"
(22.9 cm)
12.3"
(31.1 cm)
21.5"
(54.6 cm)
13.3"
(33.7 cm)
Figure 1-2. Control Module/Screen Dimensions
ST Holster and Cables
10.1"
(25.7 cm)
2.6"
(6.5 cm)
3.7"
(9.5 cm)
Figure 1-3. ST Holster and Cables Dimensions
6
Chapter 1 - System Overview
ST Probe
12.4"
(31.4 cm)
1.3"
(3.2 cm)
3.7"
(9.2 cm)
SIDE VIEW
2.1"
(5.3 cm)
TOP VIEW
Figure 1-4. ST Probe Dimensions*
* Dimensions may vary by gauge size.
HH Holster and Cables
72.5"
(184.2 cm)
8.8"
(22.2 cm)
1.9"
(4.8 cm)
Figure 1-5. HH Holster and Cables Dimensions
7
MAMMOTOME Biopsy System Service Manual
HH Probe
12.6"
(32.0 cm)
3.5"
(9.1 cm)
Figure 1-6. HH Probe Dimensions*
* MHH11 (11 GA) probe shown. Dimensions may vary for other probe sizes.
EX Holster
8.6"
(21.8 cm)
10.0’
(3.0 m)
1.1"
(2.8 cm)
Figure 1-7. EX Holster Dimensions
EX Probe
12.4"
(31.5 cm)
3.6"
(9.1 cm)
Figure 1-8. EX Probe Dimensions*
* HH11BEX (11 GA) probe shown. Dimensions may vary for other probe sizes.
8
Chapter 1 - System Overview
Footswitch
10.6"
(27.0 cm)
5.1"
(13.0 cm)
Figure 1-9. Footswitch Dimensions
Remote Keypad
1.6"
(4.0 cm)
2.0"
(5.0 cm)
3.9"
(9.8
Figure 1-10. Remote Keypad Dimensions
9
MAMMOTOME Biopsy System Service Manual
MR Probe
5.7"
(14.5 cm)
11.3"
(28.7 cm)
Figure 1-11. MR Probe Dimensions*
* Dimensions given for 145mm length probes.
MR Holster
2.1"
(5.2 cm)
13.8”
(35.0 cm)
2.1"
(5.2 cm)
Cable length: 30’ (9.1 m)
Figure 1-12. MR Holster Dimensions
10
Chapter 1 - 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)
1.6"
(3.9 cm)
48.0" +/- 4.0" (121.9 cm +/- 10.1 cm)
when fully extended (both cables).
Figure 1-14. MR Interlock System Dimensions*
* Dimensions may vary by gauge size.
11
MAMMOTOME Biopsy System Service Manual
12
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 uniboard 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
DC
Motor
DC
Motor
(ST, HH, MR)
Extractor
Controller
Interface Board
Figure 2-1. System Block Diagram
13
MAMMOTOME Biopsy System Service Manual
Uniboard/Interface Board Interface at Interface Board
Pin
Signal Definition
Pin
Signal Definition
1
2
3
4
5
6
7
8
HGND
+VHLST
+VHLST
HGND
Translational axis holster encoder A+
Translational axis holster encoder A-7
Translational axis holster encoder B+
Translational axis holster encoder B-9
9
10
11
12
13
14
15
16
Holster RX+ (input from holster)
Holster RX-11
Holster TX+ (output to holster)
Holster TX-13
HGND
HGND
HGND
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
2
3
4
5
6
7
8
HGND
+VHLST
Holster ID
ID Communication Port
Translational Motor Drive – CW
Translational Motor Drive – CCW
Rotational Motor Drive – CW
Rotational Motor Drive - CCW
9
10
11
12
13
14
15
16
Unused
Unused
Unused
Unused
Unused
Extend Switch- (active low)
Retract Switch- (active low)
Vacuum Switch- (active low)
Interface Board/ST & HH Holster Interface
Pin
Signal Definition
Pin
Signal Definition
1
2
3
4
5
6
7
8
HGND
+VHLST
+VHLST
HGND
Translational axis holster encoder A+
Translational axis holster encoder A-7
Translational axis holster encoder B+
Translational axis holster encoder B-9
9
10
11
12
13
14
15
16
Holster RX+ (input from holster)
Holster RX-11
Holster TX+ (output to holster)
Holster TX-13
Rotational axis holster encoder A+
Rotational axis holster encoder A-15
Rotational axis holster encoder B+
Rotational axis holster encoder B
Interface Board/MR Holster Interface
14
Pin
Signal Definition
Pin
Signal Definition
1
2
3
4
5
6
7
8
HGND
+VHLST
+VHLST
HGND
Low voltage differential signal A+
Low voltage differential signal ALow voltage differential signal B+
Low voltage differential signal B-
9
10
11
12
13
14
15
16
Holster RX+ (input from holster)
Holster RX- (input from holster)
Holster TX+ (output to holster)
Holster TX- (output to holster)
Unused
Unused
Unused
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.
•
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)
•
2, VCC_CARD
•
1, +5V_CTRL
•
1, +5V_FOOT
•
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):
•
3, +12V
•
3, signal grounds (LGND)
•
1, LED on/off control signal
•
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
•
A = 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).
15
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
•
UART 1 = holster
•
UART 2 = touchscreen
Interrupts
•
irq1 = 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.
System 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 I2C ADC/DAC.
The parallel DAC is used in the following manner:
16
•
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
•
System DRAM 15 Mb 2 (4M x 16) = 4M x 32 50
Analog to Digital Converter
The I2C ADC/DAC is a Philips, PCF8921AT. The I2C address is equal to 0 (A2 = 0,
A1 = 0, A0 = 1). The I2C ADC/DAC is used for the following:
•
DAC sets the vacuum system regulation value.
•
ADC0 reads the vacuum pressure value.
•
ADC1 is a spare.
•
ADC2 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,
A1 = 0, A0 = 1)
LCD and Remote 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.
17
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 sensor 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 both 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.
18
Chapter 3 - Troubleshooting
Introduction
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).
Error Codes
The following section lists the possible error conditions that may occur during operation of the
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.
Figure 3-1. Reconnect Holster Screen
1
2
3
Switch off (O) the power to the control module.
Reconnect the holster cables.
Switch on (I) 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).
Figure 3-2. Connect Remote Keypad or Footswitch Screen
19
MAMMOTOME Biopsy System Service Manual
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 switch on (I) the control module. This screen may vary depending on software version.
Figure 3-3. Incompatible Holster Screen
Level 1 Error Messages
Level 1 messages are retained in the system event log, but do not appear on the screen.
Error Code
Error Message
Probable Cause
Corrective Action
L1-001
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.
Figure 3-4. Level 2 Attention Screen
20
Chapter 3 - Troubleshooting
Error Code
Error Message
Probable Cause
Corrective Action
L2-001
L2-002
Attention: Maintenance
Product life of holster is
diminishing.
Replace used holster with a new
holster.
Level 3 Attention Messages
An L3 attention message temporarily suspends the 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.
Figure 3-5. Level 3 Attention Screen
Error Code
Error Message
Probable Cause
Corrective Action
L3-001
Probe Connection
Probe is not properly loaded into
holster.
Load probe as described in probe
package insert. Press → to continue.
L3-002
Wrong Probe
Incorrect probe loaded into holster Remove probe and load appropriate
probe as described in probe package
for desired procedure.
insert. Press → to continue.
Adjust Green Holster Cable
Excessive bending of green drive
cable.
Straighten green drive cable. Press →
to continue.
Probe Damaged
Multiple causes.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
Probe Removed
Probe removed from holster midprocedure.
Reload probe or load new probe as
described in probe package insert.
Press the EXIT button to reinitialize
the probe.
Adjust Green Holster Cable
Excessive bending of green drive
cable.
Straighten green drive cable. Press →
to continue.
Probe Damaged
Multiple causes.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
L3-003
21
MAMMOTOME Biopsy System Service Manual
Error Code
Error Message
Probable Cause
L3-004
Adjust Green Holster Cable
Excessive bending of green drive Straighten green drive cable. Press →
to continue.
cable.
Probe Damaged
Multiple causes.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
Adjust Blue Holster Cable
Excessive bending of blue drive
cable.
Straighten blue drive cable. Press →
to continue.
Probe Damaged
Multiple causes.
Reload probe or load new probe as
described in probe package insert.
Press the EXIT button to reinitialize
the probe.
L3-006
Vacuum Tubing Connections
Vacuum set connection is loose
or disconnected.
Check the following vacuum
connections for tightness:
• Flexible tube connections at
canister lid.
• Vacuum set cartridge connection.
• Canister lid.
Press → to continue.
L3-007
Black Holster Cable
Disconnected
Black electrical cable connector
on holster is not properly
connected to control module.
Properly seat black electrical cable
connector in control module. Press →
to continue.
L3-008
Footswitch Disconnected
Footswitch is not properly
connected to control module.
Properly seat footswitch connector in
back panel of control module. Press
→ to continue.
User no longer wants to use
footswitch.
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.
L3-005
L3-009
Green Holster Cable
Corrective Action
Green drive cable connector is
Properly seat green drive cable
not properly connected to control connector in control module. Press →
module.
to continue.
Green drive cable connected to
blue cable connector port.
Connect green and blue connectors to
their respective connector ports. Press
→ to continue.
Excessive bending of green drive Straighten green drive cable. Press →
cable.
to continue.
Probe Damaged
22
Multiple causes.
Unload damaged probe and load new
probe as described in probe package
insert. Press the EXIT button to
reinitialize the probe.
Chapter 3 - Troubleshooting
Error Code
Error Message
Probable Cause
Corrective Action
L3-010
Remote Keypad FORWARD
Button Activated
FORWARD button pressed by
accident.
Release FORWARD button. Press →
to continue.
L3-011
Remote Keypad REVERSE
Button Activated
REVERSE button pressed by
accident.
Release REVERSE button. Press → to
continue.
L3-012
Remote Keypad VACUUM
Button Activated
VACUUM button pressed by
accident.
Release VACUUM button. Press → to
continue.
L3-013
Footswitch FORWARD Pedal
Activated
FORWARD pedal pressed by
accident.
Release FORWARD pedal. Press → to
continue.
L3-014
Footswitch REVERSE Pedal
Activated
REVERSE pedal pressed by
accident.
Release REVERSE pedal. Press → to
continue.
L3-015
Footswitch VACUUM Pedal
Activated
VACUUM pedal pressed by
accident.
Release VACUUM pedal. Press → to
continue.
L3-016
Incompatible Footswitch or
Remote Keypad
Device other than
MAMMOTOME Footswitch or
Remote Keypad is connected to
the control module’s remote
control socket.
Remove other device connector from
the remote control socket and insert
MAMMOTOME Footswitch or
Remote Keypad connector. Press → to
continue.
L3-017
Green Holster Cable
Excessive bending of green drive
cable.
Straighten green drive cable. Press →
to continue.
Green drive cable connector is
Properly seat green drive cable
not properly connected to control connector in control module. Press →
module.
to continue.
L3-018
Probe Damaged
Multiple causes.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
Blue Holster Cable
Excessive bending of blue drive
cable.
Straighten blue drive cable. Press → to
continue.
Blue drive cable connector is not
properly connected to control
module.
Properly seat blue drive cable
connector in control module. Press →
to continue.
Multiple causes.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
Probe Damaged
23
MAMMOTOME Biopsy System Service Manual
Error Code
Error Message
Probable Cause
Corrective Action
L3-019
Inadequate Airflow through Unit
Airflow through control module
is restricted beneath or at the
back panel of the control
module.
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.
L3-020
Adjust Blue Holster Cable
Excessive bending of blue drive
cable.
Straighten blue drive cable. Press →
to continue.
Probe Damaged
Multiple causes.
Reload probe or load new probe as
described in probe package insert.
Press → to continue.
L3-021
Vacuum Tubing Connections
Vacuum set connection is loose
or disconnected.
Check the following vacuum
connections for tightness:
• Flexible tube connections at
canister lid.
• Vacuum set cartridge connection.
• Canister lid.
Press → to continue.
L3-022
Pre-Fire Position
Probe has not been fired.
Release safety lever and press → to
continue. Press the fire button on the
ST holster.
L3-023
Remote Keypad Disconnected
Remote keypad is not properly
connected to control module.
Properly seat remote keypad
connector in back panel of the control
module. Press → to continue.
User no longer wants to use
remote keypad.
1. Switch off (O) the control module.
2. Disconnect the remote keypad
from the control module.
3. Connect the footswitch to the
control module.
4. Switch on (I) the control module.
24
Chapter 3 - Troubleshooting
Error Code
Error Message
Probable Cause
Corrective Action
L3-025
Remote Keypad FORWARD
Button Activated
FORWARD key pressed
unintentionally.
1. Release FORWARD key (button).
2. Press → to continue.
Defective keypad contacts on
EX Holster.
Replace circuit board on EX Holster.
REVERSE key pressed
unintentionally.
1. Release REVERSE key (button.)
2. Press → to continue.
Defective keypad contacts on
EX Holster.
Replace circuit board on EX Holster.
VACUUM key pressed
unintentionally.
1. Release VACUUM key (button).
2. Press → to continue.
Defective keypad contacts on
EX Holster.
Replace circuit board on EX Holster.
L3-026
L3-027
Remote Keypad REVERSE
Button Activated
Remote Keypad VACUUM
Button Activated
L3-028
Invalid Translation Move Error
Translation position mismatch
between the Uniboard and the
Interface board.
Press → to continue. The cutter will
automatically retract to position 1.
L3-029
Invalid Rotation Move Error
Rotation position mismatch
between the Uniboard and the
Interface board.
Press → to continue. The cutter will
automatically retract to position 1.
25
MAMMOTOME Biopsy System Service Manual
Error Code
Error Message
Probable Cause
Corrective Action
L3-030
Invalid Translation Move Error
Translation position mismatch
between the Uniboard and the
Interface board.
Press → to continue. The cutter will
automatically retract to position 1.
L3-031
Invalid Rotation Move Error
Rotation position mismatch
between the Uniboard and the
Interface board.
Press → to continue. The cutter
will automatically retract to
position 1.
L3-032
Probe Damaged
Multiple possible causes:
error is attributed to damage
to the translation drive train.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
L3-033
Probe Damaged
Multiple possible causes:
error is attributed to damage
to the rotation drive train.
Unload damaged probe and load new
probe as described in probe package
insert. Press → to continue.
26
Chapter 3 - Troubleshooting
Level 4 Attention Messages
An L4 attention message terminates a procedure and instructs the operator to contact an EES Sales
Representative or the Service Center.
Figure 3-6. Level 4 Attention Screen
Error Code
Error Message
Probable Cause
Corrective Action
L4-002
Flash ROM Integrity Failure
Corrupted ROM.
Reinstall software. See Software
Installation Guide.
L4-003
Rotation Drivetrain Failure
A failed motor encoder.
Perform Internal Encoder Test. If test
fails, see Hardware Checks in this
chapter.
L4-004
Translation Drivetrain Failure
A failed motor encoder.
Perform Internal Encoder Test. If test
fails, see Hardware Checks in this
chapter.
L4-005
Vacuum Sensor Failure (failed
high)
A failed VSO.
A failed vacuum sensor.
Perform Vacuum/Regulator Test. If
test fails, see Hardware Checks in this
chapter.
L4-006
Vacuum Sensor Failure (failed
low) or Regulator Failure
A failed pump.
A failed VSO.
A failed vacuum sensor.
Perform Vacuum/Regulator Test. If
test fails, see Hardware Checks in this
chapter.
L4-007
Uncommanded Movement of
Rotation Motor
A failed rotation motor controller
or encoder.
Perform Internal Encoder Test. If test
fails, see Hardware Checks in this
chapter.
L4-008
Uncommanded Movement of
Translation Motor
A failed translation motor
controller or encoder.
Perform Internal Encoder Test. If test
fails, see Hardware Checks in this
chapter.
L4-009
Rotation Axis Current Limit
Circuitry Failed
A failed control module circuit
board.
Perform Excessive Torque Test. If
test fails, see Hardware Checks in this
chapter.
L4-010
Translation Axis Current Limit
Circuitry Failed
A failed control module circuit
board.
Perform Excessive Torque Test. If
test fails, see Hardware Checks in this
chapter.
27
MAMMOTOME Biopsy System Service Manual
Error Code
Error Message
Probable Cause
Corrective Action
L4-011
Rotation Axis Motor Driver
Monitoring Circuit Failed
A failed control module circuit
board.
Replace uniboard PCB assembly. See
Chapter 4 Repair and Replacement
Procedures.
L4-012
Translation Axis Motor Driver
Monitoring Circuit Failed
A failed control module circuit
board.
Replace uniboard PCB assembly. See
Chapter 4.
L4-013
Motor Uninitialized
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-014
Sequence Fail: Brake Release
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-015
Sequence Fail: Brake Set
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-016
Safety Variable Corruption
Corrupted RAM.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-017
Sequence Fail: Position Error
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-018
Sequence Fail: Motor Start
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-019
Sequence Fail: Motor Stop
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-020
Sequence Fail: Current Limit
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-021
Sequence Fail: Vacuum
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-022
Sequence Fail: Motor PWM
Select/Enable
An invalid jump in the software.
Reinstall software. See Software
Installation Guide. Replace uniboard
PCB assembly. See Chapter 4.
L4-023
Translational axis motor watchdog Failed watchdog reset (cycle
power on system).
expired.
Failed motor circuitry.
Cycle system power.
Perform Internal Encoder Test. If test
fails, see Hardware Checks in this
chapter.
L4-024
Rotational axis motor watchdog
expired.
Cycle system power.
Perform Internal Encoder Test. If test
fails, see Hardware Checks in this
chapter.
28
Failed watchdog reset (cycle
power on system).
Failed motor circuitry.
Chapter 3 - Troubleshooting
Error Code
Error Message
Probable Cause
Corrective Action
L4-025
POST ERROR - RAM Failure.
Corrupted RAM in Interface
board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-026
POST ERROR - CPLD Failure.
Failure in the Complex
Programmable Logic Device of
the Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-027
POST ERROR - ID Chip Failure.
Failure in the ID Chip of the
Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-028
Programming Checksum Error.
An invalid jump in the software
on the Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-029
Programming Block Sequence
Compromised.
An invalid jump in the software
on the Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-030
Programming Aborted
Prematurely.
An invalid jump in the software
on the Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-031
Translation Motor Failure.
A failed translation motor chip
on the Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-032
Rotation Motor Failure.
A failed rotation motor chip on
the Interface board.
Cycle system power and allow the
Interface board to perform a Power
On Self Test. Replace the Interface
board assembly if the test fails.
L4-033
Management Software and
Interface Board Software
Communication Failure.
A failure in the signal path
between the Uniboard and the
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).
L4-034
Control modulel Application
software and Interface Board
Software Communication Failure.
A failure in the signal path
between the Uniboard and the
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
Hardware Checks
Symptom
Probable Cause
Corrective Action
The control module will not
power on.
Control module is not connected
to an electrical source.
Make sure the power cord is properly
connected to the back of the control
module and to a grounded electrical
outlet.
Voltage of the control module is
inappropriate for the electrical
system being used.
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.
Mains power fuse is open.
Check the two Mains fuses and replace
if necessary as described in Chapter 4.
Power supply fuse is open.
Check the two power supply fuses and
replace if necessary as described in
Chapter 4.
Uniboard PCB fuse is open.
Check the two uniboard PCB
assembly fuses and replace if
necessary as described in Chapter 4.
Uniboard/LCD cable not
properly connected.
Ensure proper connection of cable or
replace as necessary.
Defective uniboard PCB
assembly.
Replace the uniboard PCB assembly
as described in Chapter 4.
After turning the control module
on, the screen is blank, the green
LED is not illuminated, but the
cooling fan is running.
30
Chapter 3 - Troubleshooting
Symptom
Probable Cause
Corrective Action
The control module experiences
excessive vibration and/or noise
during operation of the vacuum
pump.
Control module is not secured to
the top of the cart.
Ensure the control module is correctly
and completely secured to the top of
the cart.
Vacuum set connections are
loose.
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.
The top housing of the control
module is not properly fastened.
Ensure that all of the screws for the
housing are in place and properly
tightened. Check for any damage to
the housing.
The pump is not properly
mounted.
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.
The pump muffler is loose.
Check that the pump muffler is
properly oriented and set to correct
torque.
Defective vacuum pump.
Replace the pump. See Chapter 4.
Screen will not tilt.
Screen is being adjusted
incorrectly.
Adjust the screen using the screen
handle located behind the screen.
Screen will not stay upright.
Damage to the screen tilt locking
mechanism.
Replace the locking pin.
Screen will not rotate.
Screen has been fully rotated in
one direction.
Rotate the screen in the opposite
direction.
Screen rotates over 350˚.
Rotation stop tabs broken.
Replace the top cover.
The vacuum set cartridge cannot Locking tab is not being pressed.
be removed from the vacuum
connection slot on the front of the
control module.
Press down on the locking tab of the
vacuum set cartridge, and pull out to
remove from the control module.
31
MAMMOTOME Biopsy System Service Manual
Symptom
Probable Cause
Corrective Action
The remote keypad does not
respond when the buttons are
pressed.
Remote keypad is not properly
connected to the control module.
1. Switch off (O) the control module.
2. Properly connect the remote
keypad to the control module.
3. Switch on (I) the control module.
Remote keypad was working but
the cable became disconnected
from 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.
Remote keypad was not
connected to the control module
when the control module was
turned on.
1. Switch off (O) the control module.
2. Properly connect the remote
keypad to the control module.
3. Switch on (I) the control module.
Footswitch cable is not properly
connected to the control
module.
1. Switch off (O) the control module.
2. Properly connect the footswitch to
the control module.
3. Switch on (I) the control module.
Footswitch was working but the
cable became disconnected
from 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.
A short exists in the cable.
Jiggle the cable or try another
footswitch to reproduce the
error and replace the footswitch
if necessary.
Support arm moves when the
holster cables are adjusted.
Clamp is not tight enough.
Tighten the clamp by turning the
clamp knob clockwise.
Connections of flexible arm
seem loose.
Quick connectors are not
fastened correctly.
Disconnect quick connectors
and reconnect.
The probe will not lock into the
holster.
Foreign material is lodged in the
holster cavity or blocking the
holes in the probe body slot.
1. Unload the probe.
2. Check for foreign material.
3. Reload the probe.
One of the Procedure Screens is
active.
Switch the control module (O) off, or
navigate to the Probe Selection Screen
and reload the probe.
Rotation knob is not aligned with
12 o’clock position of the probe
(ST only).
Align the rotation knob with the 12
o’clock position of the ST probe.
Probe housing slot is not properly
seated into the firing fork.
1. Unload the probe.
2. Make sure the firing fork and the
fork screw are completely
installed.
The footswitch does not
respond when the foot pedals
are pressed.
32
Chapter 3 - Troubleshooting
Symptom
Probable Cause
Corrective Action
The control module does not
provide any “signals” or
“beeps” when the buttons on
the holster are pressed.
Footswitch is connected to the
control module.
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 (I) the control module.
Control module volume is
turned down.
At the Procedure Screen, increase the
volume of the control module
Electrical cable is loose or not
connected properly.
Make sure the electrical cable is
securely seated in the connector port
on the front of the control module.
The Reconnect Holster Screen
appears on the control module.
Cables are not properly
connected to the control module.
Switch off (O) the control module and
reconnect the cables.
ST Probe cannot be removed
from holster.
Cutter is within the sample
notch.
Retract the cutter proximal to the
sample notch.
Cart wheels will not move.
Front wheels are locked.
Unlock the cart wheels.
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MAMMOTOME Biopsy System Service Manual
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.
34
Code
Message
Possible Cause
Corrective Action
L3-002
Probe Damaged
Multiple possibilities.
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.
L3-006
Vacuum Tubing Connections
Vacuum set connection is
loose or disconnected.
1. Check the following
vacuum connections
for tightness:
• Flexible tube
connections at
canister lid.
• Vacuum set
cartridge connection.
• Canister lid.
2. Press ⇒ to continue.
L3-007
Holster Cable Disconnected
The holster is not properly
connected to control module.
1. Properly seat holster
cable connector in
control module.
2. Press ⇒ to continue.
L3-010
Holster FORWARD Button
Activated
FORWARD key (button)
pressed unintentionally.
1. Release FORWARD key
(button) on holster.
2. Press ⇒ to continue.
Chapter 3 - Troubleshooting
Code
Message
Possible Cause
Corrective Action
L3-011
Holster REVERSE Button
Activated
REVERSE key (button)
pressed unintentionally.
1. Release REVERSE
key (button).
2. Press ⇒ to continue.
L3-012
Holster VACUUM Button
Activated
VACUUM key (button)
pressed unintentionally.
1. Release VACUUM key
(button).
2. Press ⇒ to continue.
L3-019
Inadequate Airflow Through
Unit
Airflow through control
module is restricted beneath
or at the back panel of the
control module.
1. 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.
L3-021
Vacuum Tubing Connections
Vacuum set connection is
loose or disconnected.
1. Check the following
vacuum connections for
tightness:
• Flexible tube
connections at
canister lid.
• Vacuum set cartridge
connection.
• Canister lid.
2. Press ⇒ to continue.
L3-040
Low Speed Position Error
While Homing
Tight loops in mechanical
drive cable.
Loosen or straighten cable.
L3-041
High Speed Position Error
While Homing
Tight loops in mechanical
drive cable.
Loosen or straighten cable.
L3-042
Low Speed Position Error
While in Position, Sample, or
Clear Probe Mode
Object lodged in probe
aperture.
Dislodge object.
Damaged probe.
Replace probe.
High Speed Position Error
While in Position, Sample, or
Clear Probe Mode
Object lodged in sample
retrieval area.
Dislodge object.
Damaged probe.
Replace probe.
L3-043
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MAMMOTOME Biopsy System Service Manual
36
Code
Message
Possible Cause
Corrective Action
L3-044
Non MRI safe input device
connected to control module.
One of the following is
connected to control module:
EX holster, ST holster, HH
holster, remote keypad,
footswitch.
Replace incorrect holster
with MR holster; remove
footswitch or remote
keypad from ILB
connection located on the
back of the control
module.
L3-045
Interlock box not connected.
Interlock box not connected to
control module.
Connect interlock box to
back of control module.
Chapter 3 - Troubleshooting
System Checks for MR Systems
Symptom
Possible Cause
Corrective Action
The control module will not
power on.
Control module is not connected
to an electrical source.
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.
Incompatible voltage.
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.
Internal malfunction.
Contact an EES sales
representative or service
center for service.
Control module is not secured to
the top of the cart.
Ensure that the control module is
correctly and completely secured
to the top of the cart.
Vacuum set connections are
loose.
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.
Internal malfunction.
Contact an EES sales
representative or service
center for service.
The screen will not tilt.
Incorrect screen adjustment.
Adjust the screen using the screen
handle located behind the screen.
The screen will not rotate.
Screen has been fully rotated in
one direction.
Rotate the screen in the
opposite direction.
Cannot remove vacuum set cartridge
from vacuum connection slot on front
of control module.
Vacuum set cartridge will not
disengage from control module.
Press down on the locking tab
of the vacuum set cartridge
and pull out to remove from
control module.
The control module experiences
excessive vibration during operation
of the vacuum pump.
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MAMMOTOME Biopsy System Service Manual
Symptom
Possible Cause
Corrective Action
Cart wheels will not move.
Front wheels are locked.
Unlock the cart wheels.
The probe will not lock into
the holster.
Foreign material is lodged in the
holster base or blocking the holes
in the probe base.
Unload the probe, check for
foreign material, and reload
the probe.
Defective probe.
Replace probe.
The control module does not provide
any “signals” or “beeps” when the
buttons on the holster are pressed.
Control module volume is
too low.
At the Volume and Vacuum
Settings toolbar pop-up screen,
increase the control
module volume.
The holster keypad does not respond
when the keys are pressed.
Faulty cable.
Replace keypad cable.
Targeting Set Troubleshooting for MR Systems
38
Symptom
Possible Cause
Corrective Action
Cradle locking tab does not securely
hold the cradle in place with the zrail.
Cradle not seated properly.
Reseat cradle, ensuring that a
clicking sound is heard to
indicate that it has locked.
Cradle locking tab broken.
Replace cradle.
The handle on the z-screw is
defeated, or the handle breaks.
The lever is not oriented toward
the pillar, and deflects past the
stop or breaks the handle.
Make certain that the z-screw
handle is facing the pedestal
prior to inserting into the patient.
replace the targeting set if the zscrew handle is broken.
The seal is torn.
A sharp object such as the blade
cuts or tears the seal.
Minimize potential damage to
the seals by inserting the
obturator coaxially through the
thumbwheel.
One or more of the targeting set
components is damaged or missing.
Multiple possibilities.
Replace targeting set.
Chapter 3 - Troubleshooting
Symptom
Possible Cause
Corrective Action
The thumbwheel does not show the
rotational position of the aperture.
The obturator and/or probe are
inserted 180 degrees incorrectly
during imaging; no sample is
retrieved during biopsy.
When properly installed, the
probe and obturator should insert
into the targeting thumbwheel in
a singular, unique orientation.
Reinstall, ensuring that the probe
and obturator seat and latch with
the thumbwheel.
The levers fail to hold the sleeve
mount in position on the targeting
rail.
Improper aperture position
during imaging.
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.
Z-screw interferes with bore of
magnet.
Targeting rail fails to release.
Interference between targeting
set and rail.
Use the localization compression
rails to remove the targeting.
Release the angulation control to
ensure perpendicular retraction of
the targeting.
The thumbwheel does not rotate
freely on the sleeve mount.
The fit of the targeting set
components is too tight.
If the thumbwheel does not
rotate freely, replace targeting
set.
The levers jam and do not release the
sleeve assembly for adjustment.
The fit between the levers and the
sleeve mount is too tight.
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.
The buttons jam closed in the sleeve
mount, and the z-screw cannot be
adjusted except by rotation.
The fit between the buttons and the
sleeve mount is too tight.
If the buttons fail to move, rotate
the z-screw until the buttons
move. If the buttons still fail to
move, replace targeting set.
The secondary z-rail slides off of the
primary rail, interfering with the bore
of the magnet.
Spring is displaced.
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
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.
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.
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 control module.
•
40
To view the Usage Log, press the Next button on the Event Log Review screen.
Chapter 3 - Troubleshooting
Back button
Next button
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:
1
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.
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.
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MAMMOTOME Biopsy System Service Manual
4
When copying is complete, press the Next button on the following message pop-up screen to return
to the Event Log Review screen.
Message pop-up
screen
Next button
Figure 3-11. Copy Event and Usage Logs Pop-up Screen (Complete.)
5
Remove the PCMCIA card from the control module.
Note: If the PCMCIA card inserted into the control module contains application software, the
following screen appears on the display.
Figure 3-12. Copy Event and Usage Logs Pop-up Screen (Card contains application software.)
6
42
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.
Figure 3-13. Copy Event and Usage Logs Pop-up Screen (Card is not blank. . .)
7
To replace the current PCMCIA card with a blank card before copying the Event and Usage
Logs:
•
Press the Back button on the pop-up screen.
•
Insert the blank PCMCIA card in the control module when the Copy Event
and Usage Logs pop-up screen appears.
•
Press the Next button to copy the Event and Usage Logs to the PCMCIA
card.
8
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.
9
If copying the Event and Usage Logs to a PCMCIA card could not be completed, the following
pop-up screen appears on the display.
Figure 3-14. Copy Event and Usage Logs Pop-up Screen (Upload failed.)
•
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.
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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.
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.
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
Gray
front
bezel
Bezel fastener
Control module
chassis (bottom)
Top cover fastener
Figure 4-1. Removing the Control Module Housing
1
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)
2
Remove the one (1) phillips head fastener recessed in the gray front bezel between the tubing set
connection and the holster cable connections.
3
Remove the gray front bezel.
4
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 the yellow and green ground wire from the LCD assembly to the
chassis.
7
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
Gray collar
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
1
Disconnect the tube from the center port of the canister lid. (Figure 4-4. Replacing the Flexible
Vacuum Source Tube)
Clamp
Tube
Canister Lid (Center Port)
Vacuum Connector
Figure 4-4. Replacing the Flexible Vacuum Source Tube
2
Remove the clamp with a sharp instrument if necessary.
3
Remove the tube from the vacuum connector.
4
Insert the new tube over the vacuum connector and secure it with the clamp.
5
Connect the new tube to the center port of the canister lid.
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MAMMOTOME Biopsy System Service Manual
Location and Specification of Fuses
Location of
Control Module
Fuses
Voltage
Amperage
Model
Rating
Size
Type
Rating
Two fuses on
SCM12
125V
10A
3AG
Glass
inside of back
SCM23
250V
5A
5x20mm
Glass
Both
250V
6.3A
5x20mm
Ceramic
Uniboard, F1
Both
250V
3.15A
5x20mm
Glass
Uniboard, F2
Both
250V
1A
5x20mm
Glass
panel
Two fuses on
board power
supply
Mains fuses
Uniboard fuses
(Behind fan)
Figure 4-5. Fuse Location
48
Power supply fuses
Chapter 4 - Repair and Replacement Procedures
Replacing the LCD Assembly Components
1
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
Figure 4-6. Underside of the Top Cover Assembly
2
Carefully pull the LCD assembly off of the cover, pulling the cables through the top hole.
3
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
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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 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)
Two (2) phillips head fasteners
Handle spring
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
9
Compress the handle spring and insert into the handle.
If it is necessary to replace the LCD front assembly, follow steps 9a through 9f. (Figure 4-11.
Replacing the LCD Front Assembly)
Tie strap
Thumbscrew
Figure 4-11. Replacing the LCD Front Assembly
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MAMMOTOME Biopsy System Service Manual
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.
52
d
Remove the cables.
e
Secure the LCD cables to the new LCD front assembly with two new tie straps.
f
Remount the 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.
10
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.
11
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.
12
Secure with the seven (7) phillips head fasteners previously removed.
13
Clean the areas around the two fasteners flanking the speaker grille. Cover the fasteners with new
adhesive dots.
14
Reconnect the ferrite bead to the thick LCD cable near the opening of the rubber resistance fingers.
15
Reinstall the two 3/16" standoffs.
16
Place the tabletop over the LCD assembly, with the beveled tabletop surface in front of the LCD.
17
Turn the assembly over and place the turntable on the rubber surface so that the four (4) fasteners
extend from the turntable.
18
Spin the turntable to expose one of the four (4) mounting holes.
19
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.
20
Install the remaining three shoulder bolts, and completely tighten all four.
21
Pass the LCD cables, speaker cable, and ground wire through the top cover housing.
22
Align the four (4) fasteners in the turntable with the top cover.
23
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
1
Remove the remaining four (4) phillips head fasteners that 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.
8
Reconnect all wire harnesses.
9
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
1
Remove the two (2) wiring harnesses and one (1) power cable 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
1
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.
3
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
Tubing
Figure 4-14. Replacing the Vacuum Pump
54
Chapter 4 - Repair and Replacement Procedures
5
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
Ground wire
Figure 4-15. Removing the Capacitor Spade Connectors and Vacuum Pump Ground Wire
6
Disconnect the brown power wire from tab 2 of the solid state relay on the back panel of the control
module.
7
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.
8
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
Chassis
Figure 4-16. Removing the Four 1/4"-20 x 1-1/2" Fasteners on the Underside of the Chassis
9
Remove the defective vacuum pump.
10
Place the new pump over the mounting pads, ensuring that the intake port is the closest port to the
uniboard.
11
Secure the pump with the four (4) 1/4"-20 x 1-1/2" fasteners treated with Loctite® 242® on the
threads. Torque the fasteners to 120" lbs. + 5" lbs.
12
Fasten the ground wire from the pump to the chassis using the 8-32 x 1/2" phillips head fastener
removed in step 5.
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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 the intake valve.
18
Place the vacuum tubing connection on the valve and tie the strap to secure.
Replacing the Translational and Rotational Motors
1
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)
Socket receptacle
Interface bracket
Three (3)
phillips head
fasteners that
mount motor
to interface
bracket
(hidden from
view)
Fasteners
Coupling
Standoffs
Adapter
Nut
Figure 4-17. Replacing the Translational and Rotational Motors
2
With a 1.5 mm allen wrench, loosen the four (4) fasteners on each motor coupling.
3
Remove the adapter for the motor to be replaced.
4
Remove the nut and socket receptacle for the adapter.
5
Remove the coupling for the adapter.
6
Remove the three (3) phillips head fasteners mounting the motor to the interface bracket.
7
Remove the defective motor.
8
Install the replacement motor from the front of the control module as follows:
9
56
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 0º and 30º.
b
Mount the rotational motor on the left side of the bracket; angle it so that the encoder wire
harness is between 150º and 180º.
Connect the encoder and motor power wire harnesses to the uniboard PCB assembly.
Chapter 4 - Repair and Replacement Procedures
10
Slide the motor coupling over the motor shaft until the coupling bottoms out. Tighten the two (2)
fasteners.
11
Slide the plastic jam nut onto the coupling so that the chamber is on the motor side.
12
Slide the motor adapter onto the motor coupling until the adapter bottoms out.
13
Secure the adapter to the motor coupling with the screws to a torque of 3" lbs. + 0.2" lbs.
14
Remove and discard the used thread sealant tape from the green or blue receptacle.
15
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.
16
Torque the jam nut to 30.5 in.-lbs. + 1 in.-lb.
17
Reinstall and secure the two (2) standoffs with the four (4) phillips head fasteners.
Replacing the Solenoid
1
Identify the solenoid in need of replacement. (Figure 4-18. Replacing the Solenoid)
Solenoid
5/32" Allen head fasteners
Figure 4-18. Replacing the Solenoid
2
Disconnect the solenoid wire harness from the uniboard PCB assembly.
3
Using a 5/32" allen wrench, remove the three (3) allen head fasteners for the defective solenoid.
Note: These fasteners are found on the white tubing set connection block.
4
Remove the solenoid, taking note of its mounting orientation.
5
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.
6
Tighten the three (3) 5/32" allen head fasteners.
7
Restore the wire harness connection to the uniboard PCB assembly.
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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
•
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
1
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
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Chapter 4 - Repair and Replacement Procedures
4
Remove the retaining ring that captures the port shaft. This ring is copper 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-Carr ® p/n 58225A23).
Retaining ring
Figure 4-21. Removing the Retaining Ring
5
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
6
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
7
Slide the shroud upward and remove.
Note: To replace safety mechanism components, see Replacing the Safety Mechanism
Components.
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MAMMOTOME Biopsy System Service Manual
8
Remove the one (1) remaining 0.050" allen head fastener to enable the separation of the upper and
lower frames.
9
To remove the lower frame, pull slightly back on the arming levers. This will free the tabs at the front
of the frame.
10
Slide the rubber boot 1" to 2" down the cables, and away from the holster.
11
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 the 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
12
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
13
Hold the loose rotation gear in place during removal and secure with a piece of tape.
14
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.
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Chapter 4 - Repair and Replacement Procedures
Replacing the Cable Assembly
1
Remove the two drive cables from the lower clamp.
2
Remove the 3/32" allen head fastener securing the bottom clamp in place. (Figure 4-26. Replacing
the Cable Assembly)
Bottom clamp
Strain relief
3/32"
Allen head
fastener
Mounting bracket
Figure 4-26. Replacing the Cable Assembly
3
Press the strain relief of the defective electrical cable out of the bracket.
4
Press the strain relief of the new cable into the mounting bracket.
5
Install the lower transmission bracket using a new 3/32" allen head fastener.
6
Place the two drive cables back into their respective places in the bottom clamp. Ensure that the
encoder mates with the translational cable.
7
Place the encoder in the bottom clamp with the label and wires facing up.
8
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.
9
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.
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MAMMOTOME Biopsy System Service Manual
Replacing the Encoder Assembly
1
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 encoder 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
62
1
Lift the two drive cables out of the bottom transmission clamp. (Figure 4-27. Replacing the Encoder
Assembly)
2
Remove the 3/32" allen head fastener that secures the bottom clamp in place.
3
Press the strain relief of the electrical cable out of the bracket.
4
Press the strain relief of the electrical cable into the new mounting bracket assembly.
5
Install the lower transmission bracket using a new 3/32" allen head fastener.
6
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.
Chapter 4 - Repair and Replacement Procedures
8
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.
9
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.
Replacing the PCB Assembly
1
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
2
Install the new PCB and fasten with the three (3) phillips head fasteners.
3
Calibrate the PCB.
Replacing the Firing Mechanism
1
Remove the three (3) phillips head fasteners with the captured star washers to free the PCB.
2
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
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MAMMOTOME Biopsy System Service Manual
3
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
4
Remove the firing mechanism from the frame.
5
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 Krytox® lubricant to all moving metal to metal interfaces.
Firing spring
Nylon bushing and clamp plate
Figure 4-32. Nylon Bushings in the U-Channels
64
6
Capture the firing mechanism with the two clamp plates and four (4) new phillips head fasteners.
7
Mount the PCB again with the three (3) phillips head fasteners.
8
Install the firing fork and the thumbscrew.
Chapter 4 - Repair and Replacement Procedures
Replacing the Safety Mechanism Components
1
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.
Safety lever
Safety cover
5/64" Allen head fastener
Figure 4-33. Replacing the Safety Mechanism Components
2
Replace the defective safety mechanism components.
3
Reassemble the safety mechanism in the following order:
4
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.
Place the safety cover over the entire assembly and secure with the three (3) 5/64" allen head
fasteners.
Reassembling the Holster
1
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.
Wire harness
Figure 4-34. Reconnecting the Wire Harnesses to the PCB
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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 in-lbs.
Replacing the Power Cord Assembly
1
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
66
1
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.
Chapter 4 - Repair and Replacement Procedures
Locking tabs
Bottom housing
Top motor mount cover
Figure 4-35. Replacing the Bottom Housing
Replacing the Top Housing
1
Remove the power cable assembly.
2
Remove the bottom housing.
3
Remove the six (6) phillips head fasteners holding the top motor mount and top housing together.
4
Pull the top housing away from the top motor mount. (Figure 4-36. Replacing the Top Housing)
5
Inspect the seals on the top housing and around the keypad cover for damage. If damaged, the top
housing must be replaced.
6
To replace the top housing, reverse the above procedure.
Keypad
Top housing
Top motor mount
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.
1
Remove the power cable assembly.
2
Remove the bottom housing.
3
Remove the six (6) phillips head fasteners holding the top motor mount and top housing together.
4
Pull the top housing away from the top motor mount.
5
Replace the top housing (the new top housing includes the keypad).
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MAMMOTOME Biopsy System Service Manual
Replacing the Flex Circuit Assembly
1
Remove the power cable assembly.
2
Remove the bottom housing.
3
Remove the six (6) phillips head fasteners holding the top motor mount and top housing together.
4
Pull the top housing away from the top motor mount.
5
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.
6
Slide the Flex Circuit Assembly from underneath the motors and pull it up off of the alignment post,
then remove the Assembly.
7
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.
8
Apply Kapton Tape over the bare connectors on top of the Flex Circuit Assembly. (See Figure 4-37.
Kapton Tape Placement).
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).
1
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.
2
Disconnect the motor connector from the flex circuit assembly.
3
Tilt the back of the motor up until the fasteners clear the mounting brackets; then slide it back to
separate the motor shafts.
4
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
68
1
With the motor removed, press the coil pin from the motor shaft.
2
Replace the extension shaft and press in a new coil pin.
Chapter 4 - Repair and Replacement Procedures
Replacing the Rotation Motor Drive Shaft
1
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 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).
1
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
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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
1
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 drive sprocket shaft assemblies. (Figure 4-40. Sprocket Locations)
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)
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)
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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 that 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
1
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
1
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
Removing the Lens PCB Assembly from the Top Housing
1
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
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MAMMOTOME Biopsy System Service Manual
Removing the Holster Bottom from the Gearbox Tongue
1
Remove the top housing.
2
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).
3
Remove the seven (7) allen fasteners holding the gearbox tongue housing to the bottom housing
4
Pull the two (2) housings apart.
5
To reassemble, reverse the disassembly procedure.
Thumbwheel knob
Loosen to remove thumbwheel knob
Gearbox tongue assembly
Allen fasteners
Figure 4-45. Thumbwheel Knob and Gearbox Tongue Assembly
Removing the Cable and Strain Relief from the Gearbox Tongue Assembly
1
Remove the holster bottom from the gearbox tongue.
2
Remove the three (3) allen fasteners from the cable strain relief.
3
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.
4
While holding the rubber dampener, slide the drive cable assembly to the rear and remove.
5
Disconnect the power cable from the encoder.
6
To reassemble, reverse the disassembly procedure, ensuring that the wiring harness for the encoder is routed
properly.
Cable attachment housing
Input gear cover
Two (2) long fasteners
Figure 4-46. Removing the Cable and Strain Relief from the Gearbox Tongue Assembly
74
Chapter 4 - Repair and Replacement Procedures
Removing the Input Gears and Cover
1
Follow the previous steps to get to the input gear cover.
2
Remove the three (3) allen fasteners holding the input gear cover in place (Figure 4-47. Removing the Input
Gears and Cover).
3
Remove the cover, input gears and bushings.
4
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.
5
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
1
Follow the previous steps to get to the encoder.
2
Remove Kapton tape from the encoder.
3
Remove the plastic rear cover of the encoder by unsnapping and pulling it to the rear.
4
Slide the encoder fork into the 2 small openings on the side of the encoder.
5
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).
6
Loosen the setscrew.
Note: Do not remove the setscrew.
7
Remove the two (2) allen fasteners holding the encoder then remove the Encoder by sliding it to the rear.
8
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.
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MAMMOTOME Biopsy System Service Manual
Encoder shaft dimple
.035 Allen wrench
Encoder fork
Figure 4-48. Removing the Encoder from the Gearbox Tongue Assembly
Removing the Thumbwheel Shaft and Gear
1
Follow the previous steps to get to the thumbwheel shaft and gear.
2
Remove the coil pin from the shaft and gear.
3
Slide the shaft out from the rear and remove the gear.
4
Reverse above procedure to reassemble
Note: The thumbwheel shaft and gear do not have to be removed to service the gearbox assembly.
Servicing the Gearbox Assembly
1
Follow the previous steps to get to the gearbox assembly.
2
Remove the ratchet cover housing by removing the four (4) allen fasteners.
3
Pull the translation coupling assembly forward and remove (Figure 4-49. Front of Gearbox Housing).
4
Pull the thumbwheel coupling forward and remove.
Figure 4-49. Front of Gearbox Housing
76
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.
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MAMMOTOME Biopsy System Service Manual
Removing the Electrical Cable with the Lemo Connector
1
Remove the four (4) allen fasteners holding the cable breakout housings together. (Figure 4-52. Cable
Breakout Housing)
2
Remove the top housing half.
3
Unplug the Molex connector and remove cable.
4
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
1
Unwind the cable from the spool.
2
Remove the three (3) allen fasteners holding the HIB enclosure to the spool. (Figure 4-53. Removing the HIB
PCB)
3
Pull the HIB away from the spool.
4
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
78
1
Remove the HIB enclosure.
2
Unplug the two (2) Molex connectors from the PCB board.
3
Remove the two (2) allen fasteners holding the PCB to the HIB enclosure. (Figure 4-53. Removing the HIB
PCB)
4
Remove the PCB from the enclosure.
5
To reassemble, reverse the above procedure.
Chapter 4 - Repair and Replacement Procedures
HIB enclosure
HIB PCB
Cable strain relief
Molex connectors
Figure 4-53. Removing or Replacing the Drive Cable
Removing or Replacing the Drive Cable
1
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):
1
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.
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MAMMOTOME Biopsy System Service Manual
Cable
support
coil
Quick
connector
Flexible arm
Quick connector
Table brace
Clamp knob
Clamp
Figure 4-54. The Support Arm
Cart Assembly Repair and Replacement Procedures
This section describes how to replace the following cart assembly components:
80
•
Cart handle
•
Holster receptacle and bracket
•
Power cord wrap posts
•
Casters
•
Cart door latch
•
Cart door and hinges
•
Pull-out drawer guides
•
Fastener plate
Chapter 4 - Repair and Replacement Procedures
Replacing the Cart Handle
1
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)
2
Remove the handle from the handle mounts.
3
Slide the new handle into the two handle mounts on either side of the cart.
4
Line up the two (2) nuts located in the bottom of the handle with the slots on the underside of the
handle mounts.
5
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.
6
Torque each allen head fastener to 200 in.-lbs.
Cart handle
Handle mount
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):
1
Remove the two (2) #10-32 flange nuts securing the bracket in place with the 3/8" box wrench
supplied with the cart.
2
Remove the bracket.
3
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.
4
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.
5
Tighten the two (2) #10-32 flange nuts with the 3/8" box wrench.
6
Place the new holster receptacle on the receptacle bracket.
7
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.
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MAMMOTOME Biopsy System Service Manual
1/16" Allen wrench
#4-40 Button socket
head cap screw
3/8" Box wrench
Holster receptacle
#10-32
Serrated
flange nuts
Holster bracket
Figure 4-56. Replacing or Relocating the Holster Receptacle and Bracket
Replacing the Power Cord Wrap Posts
1
Remove the power cord from the wrap posts.
2
Remove the allen head fastener inside the damaged post(s).
3
Remove the damaged post(s).
4
Install the new post(s).
Replacing a Caster
1
Remove power from the control module.
2
Disconnect the holster from the control module.
3
Remove the holster from the holster receptacle and store in a safe place temporarily.
4
Open the cart door, and remove all items from inside the cart.
5
Inside the cart, locate the locking knobs that secure the control module to the top of the cart.
6
Turn the locking knobs to the left (counter-clockwise) until you can easily remove the control
module from the top of the cart.
7
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.
8
Store the module in a safe place temporarily.
9
Close the cart door.
10
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)
11
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.
12
Loosen and remove the serrated flange allen head fasteners with a 3/8" allen wrench.
13
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.
14
82
Torque each allen head fastener to 20 in.-lbs.
Chapter 4 - Repair and Replacement Procedures
Serrated flange allen head fastener
Caster
Figure 4-57. Replacing a Caster
Replacing the Cart Door Latch
1
Open the cart door.
2
Remove the female portion of the latch from the door back panel by loosening and removing the two
phillips head fasteners.
3
Replace the female portion of the latch, securing it with two phillips head fasteners.
Note: Apply a drop of Loctite® 242® on the threads of each fastener before securing the latch.
4
Remove the latch bracket from the left wall weldment by loosening and removing the two phillips
head fasteners.
5
Replace the latch bracket, securing the two (2) phillips head fasteners.
Replacing the Cart Door and Hinges
1
Open the cart door.
2
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.
3
Remove the cart door.
4
Remove the remaining phillips head fasteners securing the hinges to the door.
5
Remove the hinges from the door.
6
Replace the hinges, securing them first to the door.
7
Fasten the door to the cart by securing the other side of the hinges with phillips head fasteners.
Replacing the Pull-Out Drawer Guides
1
Open the cart door.
2
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)
3
Loosen and remove the three (3) phillips head fasteners that secure each guide to the inside of the
cart.
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MAMMOTOME Biopsy System Service Manual
Guide
Phillips head fastener
Figure 4-58. Replacing the Pull-Out Drawer Guides
4
Replace the guides and secure with phillips head fasteners.
5
Reinstall the drawer.
6
Close the door.
Replacing the Fastener Plate
1
Open the cart door.
2
Empty the top shelf inside the cart.
3
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)
4
Loosen the two knobs until the entire assembly that includes the fastener plate, two knobs, and two
e-clips can be removed.
5
Replace the entire assembly.
6
Close the cart door.
Fastener plate
Knob and e-clip
Phillips head fastener
Figure 4-59. Replacing the Fastener Plate
84
Chapter 5 - System Upgrades
Introduction
The following upgrades should be inspected for and performed, as required, on the MAMMOTOME Control
Module (SCM12 & SCM23).
Part / Assembly Original Condition
Upgrade to
Requirement
Software
Hand Held (any version 3.0 and prior)
v4.1 or higher.
Mandatory
For installation instructions,
refer to the MAMMOTOME
Software Installation Guide
(p/n P40491P01) with the
SCMSW5 software.
Software
Stereotactic (any version 2.0 and prior)
v4.1 or higher.
Mandatory
For installation instructions,
refer to the MAMMOTOME
Software Installation Guide
(p/n P40491P01) with the
SCMSW5 software.
Regulatory Label
p/n 880-000360 or p/n 880-000389
without a heart symbol in the upper
left-hand area of the label
Remove existing label
and replace with
p/n D06239P02.
Mandatory
Ground Wire
Hardware
See Ground Wire
Installation
instructions in this
chapter.
See Ground Wire
Installation
instructions in this
chapter.
Mandatory
Warranty Label
No label present
Place label (p/n 3432.325)
over one screw under
the front bezel.
Mandatory
Uniboard
All Uniboards 3432.007
ECN 017789 or earlier
See Uniboard Upgrade
Mandatory
instructions in this chapter.
Pump Wiring
Wires not routed under the power
supply bracket
See Routing of Pump
Wiring instructions in
this chapter.
Mandatory
Vacuum Pump and See Change in Vacuum Pump and
Isolation Mounts
Components instructions in this chapter.
See Change in Vacuum
As needed
Pump and Components
instructions in this chapter.
Vacuum Tubing
See Vacuum Tubing
Upgrade instructions in
this chapter.
Mandatory
DC Motor Adapter See DC Motor Adapter Upgrade
instructions in this chapter.
See DC Motor Adapter
Upgrade instructions
in this chapter.
Domestic Mandatory;
Int’l - As
needed
Regulatory Label
See Regulatory Label
Upgrade instructions
in this chapter.
Mandatory
See Vacuum Tubing Upgrade
instructions in this chapter.
See Regulatory Label Upgrade
instructions in this chapter.
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MAMMOTOME Biopsy System Service Manual
EX Upgrade
See EX Upgrade
instructions in this chapter.
See EX
Upgrade instructions in
this chapter.
MR Cart Upgrade
See MR Cart Upgrade instructions
in this chapter.
See MR Cart Upgrade
MR system
instructions in this chapter. installation
Note:
On request.
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).
86
Part / Assembly
Original Condition/Upgrade to
Requirement
Rear Thumbwheel Assembly
See Replacing the ST Holster Rotation
Knob instructions in this chapter.
Mandatory
Spade and Coupling Assembly
See Replacing the ST Holster Rotation
instructions in this chapter.
Mandatory
Coil Pin Replacement
See Coil Pin Replacement instructions
in this chapter.
Mandatory
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 depicted 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
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MAMMOTOME Biopsy System Service Manual
Uniboard Upgrade
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 kΩ Resistors
Loctite 454 (Accelerator 712)
Solder and soldering iron
Upgrade Instructions
1
Following the instructions in Chapter 4 of the MAMMOTOME Service Manual, remove the
Uniboard.
2
Add two (2) 10 kΩ 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
shall 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 kΩ 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
of
Rework
Location of Loctite
Location and
Orientation of Two (2)
10 kΩ Resistors
30 AWG Solid Teflon Wire
Figure 5-3. Upgrading the Uniboard
88
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 Required
•
Tie strap
Upgrade Instructions
1
The brown wire from the pump (plugged into relay tab #2) 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
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MAMMOTOME Biopsy System Service Manual
Change in Vacuum Pump and Components
Part Number Part Description
For Use With
Special Instructions
875-000303
Old Vacuum Pump
model #2639VGH44-337A
All SCM23s
Existing inventory should be
depleted prior to transitioning
to p/n 875-000302.
875-000336
New Vacuum Pump
model #2669VES44-337
All SCM12s
Existing inventory of pumps
(model # K48ZZDZH3250)
should be depleted first.
875-000302
New Vacuum Pump
model #2669VGH144-337
All SCM23s
Existing inventory of pumps
(model # 2639VGH44-337A)
should be depleted first.
700-001500
New Pump Isolation Mount
All versions of pumps
for SCM12 and SCM23
All 4 isolation mounts must be
the same version.
700-001930
7/16 Size 1/2" ID 1-1/4"
OD 5/64" Thick, Round Flat
Washer, Zinc Plated
New Pump Isolation Mount
(p/n 700-001500)
Additional washer placed
before the fender washer
(Refer to step 5).
700-000396-2
8-32 x 3/8" Phillips Pan Head
SEM Screw for LCD Turntable
New vacuum pumps
(model #2669VES44-337
or 2669VGH144-337)
Refer to step 15.
700-001529
1/4-20 x 1-1/2" Black Oxide Hex
Drive Button Head Screw
Old Vacuum Pumps
(model # K48ZZDZH3250
or 2639VGH44-337A)
Remaining inventory should
be scrapped and replaced
with p/n 3432.367.
3432.367
1/4-20 x 1-1/2" Stainless Steel
Torx Drive Button Head Screw
with pre-applied epoxy
Old Vacuum Pumps
(model # K48ZZDZH3250
or 2639VGH44-337A)
Single use screw that must
be discarded when removed.
3432.366
1/4-20 x 1-1/4" Stainless Steel
Torx Drive Button Head Screw
with pre-applied epoxy
New Vacuum Pumps
(model #2669VES44-337
or 2669VGH144-337)
Single use screw that must
be discarded when removed.
700-001929
90˚ Elbow Adapter
New Vacuum Pumps
(model #2669VES44-337
or 2669VGH144-337)
Provides additional clearance
for the tubing.
Description of Changes in the Isolation Mount
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 all 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.
90
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 singleuse 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 inventory 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 2639VGH44-337A 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
1
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 – 2669VES44-337
for 115V or 2669VGH144-337 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 small 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
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MAMMOTOME Biopsy System Service Manual
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/lbs ± 5 in-lbs.
Pump Constraint
Secured to Chassis
(p/n 3432.087)
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 over the pump constraint.
11
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
92
Chapter 5 - System Upgrades
12
Repeat steps 3 through 11 to install the remaining pump components.
13
Complete the installation of the pump according to the instructions in Chapter 4 of this manual.
14
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
Front
#8-32" Phillips Pan Head Fastener (700-000396-2)
Figure 5-8. 90˚ Elbow Adapter Placement
15
On the LCD assembly, replace one of the #8-32 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).
16
Reassemble the control module as described in Chapter 4 of this manual.
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MAMMOTOME Biopsy System Service Manual
Vacuum Tubing Upgrade
The purpose of this modification 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
94
1
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).
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. Reattaching 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).
Front Bezel
90˚ Elbow Adapter (P/N 700-001929) Oriented toward Front Bezel
Figure 5-13. 90˚ Elbow Adapter Placement
96
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).
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.
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MAMMOTOME Biopsy System Service Manual
Replacing the ST Holster Rotation Knob
1
Disassemble the ST Holster (see Chapter 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
Figure 5-15. Assembling the Firing Latch Block and Safety Latch to the Top Frame
98
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-lbs. +/- 1 in-lbs.
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).
Chapter 5 - System Upgrades
Positioning
Spring
Manual Spade
with Coupling
Assembly
Figure 5-16. Installing the Manual Spade with Coupling Assembly
New rotation knob
Figure 5-17. New Rotation Knob
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MAMMOTOME Biopsy System Service Manual
Coil Pin Replacement
Materials/Equipment Required
Part Description
Old Part Number
New Part Number
Manual Spade Assembly
CEA442-99S
CEA665-31S
Coiled Pin
CLDP031X187MDPS
CLDP047X187MCP
Port Shaft
CEA237-707S
CEA663-85S
Spur Gear
A1N1-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
1
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 fixture
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 CEA663-85S), and new spur gear (p/n
CEA664-85S)
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
Chapter 5 - System Upgrades
DC Motor Adapter Upgrade
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
1
Remove the front interface bracket.
2
Discard the following components:
•
Compression Coupling 700-001526
•
DC Motor Adapter 3432.156
•
Front Interface Bracket 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).
Figure 5-18. Washer Assembled onto Motor
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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-lbs 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.
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).
Figure 5-20. Complete DC Motor Adapter Assembly
102
8
Repeat steps 5 through 7 for the additional DC Motor Adapter assembly, if applicable.
9
Complete reassembly of control module.
Chapter 5 - System Upgrades
Upgrading Regulatory Label on Control Modules SCM12 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
1
Replace label D06239P02 with label D15611P02.
Figure 5-21. Correct Label D15611P02
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MAMMOTOME Biopsy System Service Manual
Upgrading Control Modules SCM12 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,
8-32 threads, 3/8" length
5
95000A192
8-32 X 5/16" PPHMS, nylon, Phillips head
5
28A0640-0A0
Ferrite Shield, Clip-on plastic shrouded
1
D15356
Mammotome EX Label
1
UpgradeProcedure
1
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)
Figure 5-22. Capacitor and Base Plate View
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Chapter 5 - System Upgrades
4
5
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).
Figure 5-23. Holster Interface Harness Identification
6
Attach a ferrite bead (p/n 28A0640-0A0) to the end of the holster interface harness (See Figure 5-24. Ferrite
Bead Location)
Figure 5-24. Ferrite Bead Location
7
Connect the uniboard interface harness (p/n 3432.407) to the uniboard and route over the top of the motor wire
harness assemblies (See Figure 5-25. Harness Routing)
Figure 5-25. Harness Routing
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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)
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).
Figure 5-27. Power Connector Wire Harness Routing
11
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 Routing II).
Figure 5-28. Power Connector Wire Harness Routing II
106
Chapter 5 - System Upgrades
13
Route the power connector wire harness alongside the vacuum pump wire harness, and secure both
harnesses to the base plate with a tie strap.
14
Using an ESD safe technique, remove the interface board from the packaging.
15
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)
16
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).
17
Connect the holster interface harness from the front interface bracket to the interface PCBA.
Figure 5-29. Interface Board Connections
18
Connect the uniboard interface harness to the interface PCBA.
19
Connect the power connector wire harness to the interface PCBA.
20
Record the serial number of the interface board in the service history record of the unit.
21
Reassemble the control module.
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MAMMOTOME Biopsy System Service Manual
Mammotome EX Identification
1
Affix the EX label to the lower left corner of the rear bracket (See Figure 5-30. Location of Mammotome EX
Upgrade Label)
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 & Open
1
Assembly Instructions
1
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 Service Manual
Locking knob
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
Right saddle assembly
Figure 5-32. Placing the Saddle Assemblies on the Cart
110
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).
Chapter 5 - System Upgrades
Fastener, 10-32 x 1/2 PFHMS
Fastener, 4-40 x .375 BSHCS
Fastener, 10-32 x 1/2 BSHCS SS
Figure 5-33. EX/HH Bracket and
Docking Cup Assembly
7
Figure 5-34. MR Bracket and
Docking Cup Assembly
Figure 5-35. ST Bracket Assembly
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. Installing 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.
8
Mount the tube set hanger to the top of the cart door.
9
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
MR
Mounting block
Tube set hanger
MR Unsafe label
MR
Figure 5-36. Installing the Bracket and Docking
Cup Assemblies
Figure 5-37. MR Unsafe label Placement
Location on Control Module
111
MAMMOTOME Biopsy System Service Manual
112
Chapter 6 - Electrical Safety Testing
Introduction
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
1
Connect the High Voltage port of the tester to the mains of the unit under test.
2
Connect the Return port of the tester to the ground lug of the unit under test.
3
Set the tester to 1200AC volts (1834 VAC for SCM23) for one second with a one-second ramp.
4
The current limit should be set to 10mA (15mA for SCM23).
5
Update Figure 6-1. Electrical Safety Test Results, with test results.
Mains to Patient Test Procedure
1
Leave the High Voltage port of the tester connected to the mains of the unit under test.
2
Connect the Return port of the tester to all pins of the holster electrical connector.
3
Set the tester to 3000AC volts for one second with a one-second ramp.
4
The current limit should be set for 20mA.
5
Update Figure 6-1. Electrical Safety Test Results, with test results.
Ground Continuity Test
1
Connect the unit under test to the electrical receptacle of the tester.
2
Connect the continuity port of the tester to the ground lug of the unit under test.
3
Set the tester to a limit of 30A and 0.1 Ω.
4
Update Figure 6-1. Electrical Safety Test Results, with test results.
113
MAMMOTOME Biopsy System Service Manual
Figure 6-1. Electrical Safety Test Results
Procedure
Test Specification
Mains to Earth Ground Test
< 10mA
Mains to Patient Test
< 20mA
Ground Continuity Test
< 0.1 Ω
Tested Value
Tested By (Print name): __________________________________________
Signature: __________________________________________ Date: __________________
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 EndoSurgery Inc.’s obligation under this warranty is limited to the repair 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 Package 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. AND IS 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
P43538P04
REF
SCM12
SCM23
HHHC1
STHC1
HHEX
SCMH1
SCMH2
SCMH3
SCMS1
SCMS2
SCMA1
SCMSW4
SCMSW5
MFSW1
MKEY1
HH11BEX
HH8BEX
MHH11
MHH11B
MHH14
MHH8
MST11
MST11B
MST14
MST8
MRH1
MRLB1
SCMSW6
SCMC1
SCMC3
MUPG4
Ethicon Endo-Surgery (Europe) GmbH
Hummelsbuetteler Steindamm 71
22851 Norderstedt
Germany
Johnson & Johnson AG
CH-8957 Spreitenbach
SWITZERLAND
Ethicon Endo-Surgery, Inc.
Cincinnati, OH 45242-2839 USA
1-800-USE-ENDO
Guaynabo, Puerto Rico 00969 USA
2008
2007
P43538P04
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