Neoprobe 2300
Neoprobe 2300
Neoprobe 2300
(GDS)
SERVICE MANUAL
R ONLY
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2004, All Rights Reserved
Table of Contents
1. INTRODUCTION .......................................................................................................................... 2
1.1. ABOUT THIS MANUAL ............................................................................................................... 2
1.2. PURPOSE .................................................................................................................................... 2
1.3. SCOPE ........................................................................................................................................ 2
1.4. SERVICING PERSONNEL ............................................................................................................. 3
1.5. TRAINING................................................................................................................................... 3
1.6. CUSTOMER FEEDBACK............................................................................................................... 3
2. WARNINGS, CAUTIONS AND NOTES..................................................................................... 3
2.1. OVERVIEW ................................................................................................................................. 3
2.2. DEFINITIONS .............................................................................................................................. 3
2.3. WARNINGS ................................................................................................................................ 4
2.4. CAUTIONS .................................................................................................................................. 5
2.5. NOTES........................................................................................................................................ 5
3. SPECIFICATIONS ........................................................................................................................ 6
3.1. PRODUCT SPECIFICATIONS ......................................................................................................... 6
3.2. SYMBOLS ................................................................................................................................... 7
4. TECHNICAL OVERVIEW .......................................................................................................... 8
4.1. OVERVIEW ................................................................................................................................. 8
4.2. SYSTEM OPERATION .................................................................................................................. 8
4.3. PROCESSING ARCHITECTURE ..................................................................................................... 8
4.4. OPERATOR INPUTS ..................................................................................................................... 8
4.5. OPERATOR OUTPUTS ................................................................................................................. 8
4.6. ELECTRONIC INPUT/OUTPUT (I/O) PORTS.................................................................................. 8
4.7. ENCLOSURE ............................................................................................................................... 9
4.8. CONNECTORS AND CABLING...................................................................................................... 9
4.9. GDS COMPONENTS.................................................................................................................... 9
4.10. SAFETY DESIGN ....................................................................................................................... 11
4.11. ELECTROMAGNETIC COMPATIBILITY ....................................................................................... 11
4.12. SAFETY AND EMC SERVICE CHECKLIST.................................................................................. 11
4.13. APPLICATION SOFTWARE UPGRADE ........................................................................................ 12
5. DIAGNOSTIC TROUBLESHOOTING .................................................................................... 13
6. DISASSEMBLY, SERVICE PART INSTALLATION AND RE-ASSEMBLY ..................... 16
6.1. OVERVIEW ............................................................................................................................... 16
7. PERFORMANCE VERIFICATION .......................................................................................... 17
7.1. OVERVIEW ............................................................................................................................... 17
8. DISCLAIMERS ............................................................................................................................ 17
8.1. AUTHORIZED SERVICE REPRESENTATIVES .............................................................................. 17
8.2. SERVICE BY GDS OWNERS ...................................................................................................... 17
8.3. PARTS ...................................................................................................................................... 18
8.4. SAFETY .................................................................................................................................... 18
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2004, All Rights Reserved
1. INTRODUCTION
1.1. About This Manual
Bulleted lists indicate general information about a particular function or procedure. They
do not imply a sequential procedure.
GDS graphics or emblems of the display that appear in this manual are shown exactly as
they appear on the screen.
1.2. Purpose
This manual provides the necessary information for an experienced biomedical
instrumentation technician to perform routine service operations on the Neoprobe Corporation
GDS Gamma Detection System for the Model 2300 or 2200. See Service Manual 00-0059 for
the Models 2000 or 2100.
1.3. Scope
This manual gives instructions for the servicing of the GDS including diagnostic sequences to
troubleshoot and isolate failures, assembly sequences required to remove and replace suspect
service parts, and performance verification sequences to ensure that the performance of the
repaired unit meets Neoprobe Corporation specifications. This manual does not include any
servicing capability for the Neoprobe Corporation detector probes, cables or accessories.
These items are not serviceable in the field. This manual is not intended to provide detailed
repair procedures and technical documentation to isolate failures to the lowest possible level.
It also does not discuss how to perform surgery and procedures for nuclear medicine.
This manual is not intended to support the remanufacture and resale of the GDS by third
parties.
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CAUTION: Specific information provided to the service technician to prevent the incorrect
servicing of the device that may affect performance or safety of the device.
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2004, All Rights Reserved
NOTE: General information provided to the service technician to further explain or clarify the
proper servicing of the device.
2.3. Warnings
WARNING: Disconnect the power cord from the power outlet before opening
the GDS console.
WARNING: The internal electronics of the GDS are sensitive to damage from
electrostatic discharge (ESD). Use appropriate precaution when opening and
servicing the unit.
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2.4. Cautions
CAUTION: Replace wire ties and reroute wires as they were initially found.
2.5. Notes
Calibration & Preventive Maintenance: The GDS is shipped set to factory specifications.
Preventive maintenance is limited to: external cleaning of the GDS; fuse replacement; and
functional diagnostics. No Calibration is required.
The volume knob may be damaged by mechanical shock.
In the unlikely event of a malfunction or failure, Neoprobe Corporation recommends that
owners of GDS devices contact Neoprobe Corporation to schedule service.
Replacement of certain items will require reprogramming of the unit. Contact Neoprobe
Corporation to arrange for reprogramming of the unit.
“Error No Probe” and “No Linc” are normal operating messages when no probe is
connected to the console. If the probe is connected to the console and these errors do occur,
check probe and cable connections.
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3. SPECIFICATIONS
3.1. Product Specifications
The GDS complies with the following specifications. Service replacement parts ordered
through Neoprobe Corporation also comply with the appropriate specifications listed.
Personnel performing service on the GDS must understand these specifications and must
ensure that all servicing activities performed on the GDS do not compromise any of these
specifications.
Product Classification Standard or Regulation
System: Class I, Exempt USA, 21 CFR § 892.1320
Class IIa Europe, Medical Device Directive
Class II Canada, Therapeutic Device Regulation
Class II Australia, Therapeutic Device Regulation
Model 2300 Type CF EN 60601-1/2 1), 2)
and 2200
Console Equipment NOT SUITABLE for use in the presence of
AP Flammable ANESTHETIC MIXTURE WITH AIR or
Explosion
OXYGEN or NITROUS OXIDE
Fluid Ingress IP X4 – Protected against splashing water
Mode of Operation Continuous Operation
Degree of Mobility Stationary, non-mobile
Protection against EN 60601-1/2 1) and Fused and removable power cord
electrical shock with hospital grade connector.
Probes Fluid Ingress IP X7 – Protected against the effects of immersion
Cables Fluid Ingress IP X4 - Protected against splashing water
1) Product safety testing of the initial design is certified through laboratory testing conducted by a certified third party
testing laboratory. Ongoing production testing assures that each device continues to comply with these criteria.
2) The degree of protection from electrical shock is based on the system configured with reusable metal encased probes
(Model 1017 or 2059).
NOTE: Use only power cords with 18 gauge wire and hospital grade plugs that comply with
one or more of the following agency approvals as indicated:
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3.2. Symbols
MMYYYY
Hazardous Voltage
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4. TECHNICAL OVERVIEW
4.1. Overview
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4.7. Enclosure
The GDS enclosure is designed to comply with applicable global regulatory requirements for
safety (EN60601-1-1) and electromagnetic compatibility (EN60601-1-2, EN55011). To meet
design requirements, two housing pieces have interlocking ribs combined with a tongue and
groove joint to provide strength and a water seal. Rigidity of the enclosure is obtained by
screwing the front and rear housings together.
The exterior walls of the housings are angled to allow fluids to flow off of the enclosure. The
tongue and groove allows the placement of a gasket to prevent ingress of fluids at the seam
location. The buttons are designed to prevent entry of fluids while maintaining tactile feel and
feedback.
External components are resistant to most common disinfectants used to clean medical devices
outside of a sterile field.
4.8. Connectors and Cabling
The GDS console contains both externally accessible and internal cabling. Connectors and
cables meet applicable regulatory requirements and environmental conditions.
4.9. GDS Components
The GDS contains the following major items (refer to Figure 4.9-1 and to Section 11.7 for a
list of authorized service parts):
GDS Board (P301)
The GDS board processes inputs from the probe and generates control signals for the audio
output and visual displays. The GDS also processes operator inputs and electronic
input/output (I/O) of data with external devices. The GDS board includes electrically re-
programmable memory used for current and future software upgrades. A Texas Instruments
TMS320-series DSP operating at 150 MHz is the main processor device used on the GDS
board.
The GDS board contains an isolation barrier between the DSP and the interface circuitry for
the external probe. The isolation barrier includes ±12V and +5V isolated power supplies, and
digital optoisolators. Generation and conversion of analog probe signals is implemented on the
isolated section of the GDS board so that digital optoisolators can be used for all isolation to
preserve signal integrity over the intended range of operation.
Display Board (P300)
The display board serves as a mounting platform for the display components, switches, power
supplies, and the GDS board.
Auxiliary Board (P302 (2200) or P403 (2300))
The auxiliary board serves as a junction box for the rear housing and acts as a mounting point
for the I/O connectors and the radionuclide switch. The auxiliary board includes isolation for
the signal input/output ports. The auxiliary board for the Model 2300 also includes the
Bluetooth communications hardware for connection to wireless probes.
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1. Display Board
2. GDS Board
3. Auxiliary Board
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Figure 4.10-1 Inside View of the GDS (Model 2300 and 2200)
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2003, All Rights Reserved
5. DIAGNOSTIC TROUBLESHOOTING
This table provides solutions to correct some problems if the GDS Gamma Detection System is not operating properly. (Also see Chapters 4 and 5 of the GDS Operation Manual).
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Step 1. Step 2.
Remove five (5) screws from the rear Gently separate the front and rear housings.
of the unit with a No. 1 or No. 2
Phillips head screwdriver. Gently
remove the volume adjustment knob.
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7. PERFORMANCE VERIFICATION
7.1. Overview
Neoprobe Corporation recommends servicing technicians complete the pre-closure checklists
prior to completing the following performance verification checklist for the GDS. The
performance checklist is necessary to determine proper operation of the unit. If any problems
observed in performance after servicing indicates that the unit is not working properly, it
should be returned to Neoprobe Corporation for evaluation (See 11.8 for Service Checklist).
Operation Verification Observation
Complies with Institute procedure and device
Electrical Safety Test Per Institute Procedure
ratings
Power Up Unit Verify LEDs All LEDS light
Verify Cooling Fan Cooling Fan operating
Connect cable and probe to
console or Link wireless probe “Error No Probe” / “No Linc” message disappears
to unit
Diagnostic Test VITM – top half display All indicators light
(RE: Section 4.1 of
GDS Operation VITM – Bottom half display All indicators light
Manual)
ICTM – button presses All buttons respond
Operational - Set to Dynamic Pitch, Tc-99m,
Target Count display is active
Dynamic Pitch Mode and 1000cps
(use Tc99m or Co-57 Position probe over source of
Confirm display counts and audible response to
radiation source for radiation to get 250cps to
radiation source
these steps) 1000cps
Activate Target Count over
Confirm response to radiation source
radiation source
Repeat Target Count Confirm consistent operation and resulting cps
Without moving source, select
Dynamic Pitch, Tc-99m, and Confirm LED, display count, and audio over range
100cps
Without moving source, select
Dynamic Pitch, I-131, and Verify no response to radiation source
100cps
8. DISCLAIMERS
8.1. Authorized Service Representatives
Authorized service representatives of Neoprobe Corporation may perform Service of the GDS
Gamma Detection System to the extent described in this service manual. Any unauthorized
servicing operations performed on the GDS shall automatically void the warranty.
8.2. Service by GDS Owners
Neoprobe Corporation authorizes owners of the GDS, and other independent entities
authorized by owners of the GDS, to service the GDS Gamma Detection System to the extent
described in this manual. Service of the GDS by owners or other entities may, at Neoprobe
Corporation’s sole discretion; void any remaining warranty on the unit. Neoprobe Corporation
shall not be liable for any claim for damages resulting from servicing operations performed on
the GDS by owners or other entities authorized by owners.
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2004, All Rights Reserved
8.3. Parts
Replacement parts used in the repair of the GDS must be obtained through Neoprobe
Corporation. Neoprobe Corporation cannot ensure the proper performance of the unit if any
replacement parts are obtained from any other source. Use of any unauthorized parts in the
repair of a GDS shall automatically void the warranty.
Neoprobe Corporation shall not be liable for any claim for damages resulting from the use of
unauthorized parts in the GDS.
8.4. Safety
The GDS incorporates safety features in the internal construction and wiring that are necessary
to maintain the required electrical safety rating. Personnel servicing the GDS must be familiar
with these safety features, and must not compromise any of these safety features. Use of any
unauthorized wiring or other compromise of the GDS safety features shall automatically void
the warranty.
Neoprobe Corporation shall not be liable for any claim for damages resulting from
unauthorized wiring or other compromise to the safety features of the GDS.
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Return the entire GDS or other product in its original packing. The shipment must be clearly
labeled with the RMA number and prepared in accordance with good commercial practices.
Shipment to the Company shall be at Buyer’s expense. Repaired or replacement equipment
will be shipped by the Company to the Buyer with shipping and insurance costs paid for by the
Company (C.I.P.). Non-verified problems or defects are subject to an evaluation charge.
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2004, All Rights Reserved
10. WARRANTY
Service Warranty: Service and service parts provided by Neoprobe Corporation (“the
Company”) are warranted against defects in workmanship and materials for a period of 90
days from the date of shipment by Company to Buyer, subject to the limitations
hereinafter set forth. Should any defects be found and reported during that period,
Company, at its option, will repair or replace such defective equipment provided that
Buyer ship the product containing the defect to Company, transportation charges prepaid,
with notice of the defect and representation that the equipment has been properly installed,
maintained, and operated within the limits of rated and normal usage. The repaired or
replacement equipment will be shipped C.I.P. (carriage and insurance paid) from the
Company’s plant.
This warranty shall not apply to any service parts where the installation or servicing of
such service parts is improper, or where service parts are operated above rated load
capacity, or subjected to accident, tampering, alteration, or abuse. THE COMPANY’S
LIABILITY UNDER THIS WARRANTY OR ANY OTHER WARRANTY
WHETHER EXPRESS OR IMPLIED IN LAW OR FACT SHALL BE LIMITED
TO THE REPAIR OR REPLACEMENT OF DEFECTIVE MATERIAL AND
WORKMANSHIP, AND IN NO EVENT SHALL THE COMPANY BE LIABLE
FOR CONSEQUENTIAL OR INDIRECT DAMAGES.
THIS WARRANTY ALONG WITH ANY APPLICABLE PRODUCT WARRANTY
(SEE OPERATION MANUAL) CONTAINS THE ENTIRE OBLIGATION OF
NEOPROBE CORPORATION AND NO OTHER WARRANTIES INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE OR OTHER WARRANTIES EXPRESSED,
IMPLIED, OR STATUTORY ARE GIVEN.
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11. APPENDICES
11.1. Model 2300 and 2200 Functional Schematic
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1 ISOCOM Common
2 CTL2 +5 VDC
3 CTL1 +5 VDC
4 BIAS > 50 VDC
5 +12 VDC 11.4 VDC – 12.6 VDC
6 SIG Input Impedance, 10 kΩ – 30 kΩ
7 ISOGND Common
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Figure 11.5-1 Probe Input Connector Assembly (Model 2300 and 2200)
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4
2
1. Front Housing
2. 12VDC Converter
3. Display Board
4. EMC Shield
5. GDS Board (Inside EMC Shield)
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11.6. GDS Rear Housing Assembly P158; Line Filter and P151; Fuses (2)
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1 2
5 4
1. Rear Housing
2. Line Filter
3. Auxiliary Board
4. Fan
5. Speaker
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To order Neoprobe Corporation authorized service parts contact Neoprobe Corporation at 1-800-793-0079 or 614-793-7500.
Make sure you identify your GDS by Model and Serial numbers and state the service parts that you require by the PXXX
number from the table above. Also indicate the version of software currently installed in your GDS.
NOTE: Owners of the GDS are allowed to reproduce this page so that they can capture the service history
of the GDS.
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neoprobe® GDS - SERVICE MANUAL –00-0683 Rev. B Neoprobe Corporation ©2004, All Rights Reserved
NOTE: Owners of the GDS are allowed to reproduce this page so that they can capture the service history
of the GDS.
Parts Replaced:
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