gamma c-12 multicrystal gamma counter manual

GAMMA-C12 Multicrystal Gamma Counter

& -

GAMMA Management Systems (GMS)

Software

Installation and Set-up Guide

Document number: 600277-** Revision A June 1,2000

Table of Contents

CHAPTER 1- INTRODUCTION .......................................... .................................... 1 -I

1.1 Intended Use ...................................................................................................................... 1 - 1

1.2 Special Instructions and Precautions ............................................................................. 1 -1

1.3 High Voltage ................................................................................................................... 1 -1

1.4 Grounding and Mains Supply .......................................................................................... 1-1

1.5 Components of the GAMMA-C 12 ................................................................................. 1 - 2

1.6 System Requirements ..................................................................................................... 1 -3

1.7 Control Panel ................................................................................................................... 1 - 3

.................................................................................................................. 1.8 Video Monitor 1-3

.......................................................................................................................... 1.9 Keyboard 1-4

. 1 10 Printer ............................................................................................................................. 1 -5

.................................................................................. CHAPTER 2- SYSTEM SET-UP 2-1

2.1 Installation ...................................................................................................................... 2-1

...................................................................................................................... Televideo 2 - 1

............................................................................................................................... GMS 2 - 1

2.2 Dialog with the GAMMA-C2 .......................................................................................... 2-1

2.3 The Main Menu ............................................................................................................ 2 - 2

CHAPTER 3- DIALOG MODES .................................. ................................................. 3-1

3.1 Change Directory ......................................................................................................... 3 - 1

3.2 Create Protocols ............................................................................................................ 3 - 3

3.3 List Options ...................................................................................................................... 3-4

.................................................................................................... ........... 3.4 Patient ID Files ,. 3 - 5

3.5 Televideo 99 Set-up Parameters ................................................................................... 3 - 6

600277-00-A Gamma Counter Install and Set-up 1

CHAPTER 4- CALIBRATION OPTIONS ~~.~..~..~.~..~..~~.~ .............. ............................. 4 - 1 6

4.1 H.V..Adjust ...................................................................................................................... 4-1

General ............................................................................................................................ 4-1

Procedure for One-Source Calibration ............................................................................. 4-4

Procedure for Multi-Source Calibration ........................................................................... 4.5

4.2 Standardization ................................................................................................................ 4-5

General ............................................................................................................................ 4-5

Procedure for Single-Channel Standardization (1 Source) .............................................. 4-5

Procedure for Dual-Channel Standardization (1 Source) ................................................ 4-9

Procedure for Standardization with :12 Detectors ......................................................... 4 1 0

4.3 Chi-square Test .............................................................................................................. 4-12

.......................................................................................................................... General 4 1 2

..................................................................................................................... Procedure 4 - 13

............................................................................................................... 4.4 1nstrument.QC -4- 15

.......................................................................................................................... General -4- 1 5

....................................................................................................................... Procedure 4 1 6

CHAPTER 5- GAMMAmC12 GMS SOFTWARE m m m m m m m m m m m ~ ~ m m m m m m ~ m m ~ m ~ m m m ~ m m m m ~ m m m m m m m m m m 5-1

. 5.1 htroduction .................................................................................................................... 5 1

....................................................................................................... 5.2 System Requirements 5 - 1

5.3 System Set-up .................................................................................................................... 5-2

5.4 Microcomputer Set-up ...................................................................................................... 5-3

............................................................................................................... 5.5 GMS Installation 5-3

................................................................................................... 5.6 Installing the Digiboard -5-4

11 600277-00-A Gamma Counter Install and Set-up

(1) Press Space Bar to select "NO". Press Return.

(2) Enter up to 15 characters as a comment.

(3) Choose between preprogrammed channels (1251, 57Co) and the freely selectable channels A, C/D and 57CoJ1251.

(4) Answer NO, if only one source is available.

(5) Enter the measuring tirne in minutes. Since the standardization must be performed with high statistical accuracy, we recommend counting approximately 100,000 counts per detector. select the measuring time according to the activity of the source.

(6) Enter the measuring tirne for the background measurement in minutes, the background measurement is automatically done after the standardization is finished. The time for the background measurement should not be less than 5 minutes.

(7) If the question "Input C:orrect?" is confirmed, the rack configuration is displayed on the screen:

: SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE I I I

I 4

: 7 8 9 10 1 1 12 I I

I I I I I I : SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE : I I

INSERT TRAY AND PRESS KEY "STARrr/STOP TO START MEASUREMENT

PRESS "HOME" TO EXIT

Rack display on the screen showing the position of the source in the rack

Place a tray containing the source into the detector block in the position displayed on the screen (usually detector #I) and start the measurement with the STARTISTOP button.

If the red LED in the STARTISTOP button goes out, the next detector is automatically displayed on the screen (usually detector #2). Put the source into the proper well and start the measurement again by pressing STARTISTOP.

- - - - - - -- - - --

Gamma Counter Install and Set-up 600277-04-A 4-7

Proceed in the same manner until all 12 detectors have been standardized. The screen displays:

. . . . . . . . . . . . . . . . . . . . . BKGD

I I

j 1

I I I I I

I

i 7 I I

: BKGD

- - - - - - - - - - - * - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - , I

BKGD BKGD BKGD BKGD BKGD 1 I

I I

2 3 4 5 6 , I I

C U R R E N T R A C K #

BKGD BKGD BKGD BKGD BKGD I I

I I

INSERT TRAY AND PRESS KEY "STAKT/STOP" TO START MEASUREMENT

PRESS "HOME" TO EXKT

Rack display for the background measurement.

Remove the source from the well and press STARTISTOP button again to start the background measurement.

A complete printout of the standardization is automatically created.

The GAMMA-C12 can start its routine operation only after the counter has been standardized by means of the isotope to be used for the measurement.

*Refer to GAMMA-C 12 Operator's Manual, Appendix A, for example of Printout.

4-8 60027:7-04-A Gamma Counter Install and Set-up

Procedure for Dual-Channel Standardization (1 Source)

Select STANDARDIZATION from the CALIBRATION OPTIONS menu. The screen displays:

1 STANDAKDIZATION

(1) COMMENT : One Source

(2) ISOTOlPE 1251 (3) ALL DETECTORS AT ONCE : NO

(4) STAND. -MEASUREMENT TIME 57Co (MIN): 1.000

STAN>. -MEASL.MENT TIME 1251 (MIN): 1.000

(5) BKGD. -MEASUREMENT (MIN) 5.000

INPUT ON THIS PAGE CORRECT?: YES

PRESS SPACE BAR TO SELECT >NO

PRESS "HOME" TO EXIT MEASUREMENT LOCKED I Dual-channel standardization


(2 ) Enter up to 15 characters.

(3) Choose between the pre-programmed channels (57Co11251) for double labels and the free channels C/D.

(4) Press Space Bar to answer "NO", if only one source is available.

(5) Enter the measuring time in minutes. Since the standardization must be performed with high statistical accuracy, we recommend counting approximately 100,000 counts per detector. Select the measuring time according to the activity of the source.

(6) Enter the measuring time for the background measurement in minutes, the background measurement is automatically done after the standardization is finished. The time for the background measurement should not be less than 5 minutes.


The measurement is very similar to the Single-Channel Standardization. The operating sequence displayed on the screen must be observed carefully: first place the "high-energy" nuclide in the detectors 1,2,. . . . .12 and then repeat the whole process with the "low-energy" nuclide. Wait until the background measurement (with empty rack) is completely finished.

Procedure for Standardization with 12 Detectors

Select STANDARDIZATION from the CALIBRATION OPTIONS menu. The screen displays:

If the comment displayed does not say "matched Source", press the Space Bar to select "NO". Press Return and enter "matched source" into the comment line.

Choose the isotope to be used.

STANDARDIZATION

COMMENT : Matched Source

ISOTOPE 1251 ALL DETECTORS AT ONCE : YES

STAND. -MEASUREMENT TIME (MIN): 1 .OOO

BKGD. -MEASUREMENT (MIN) 5.000

INPLJT ON THIS PAGE CORRECT?: YES

PRESS SPACE: BAR TO SELECT >NO

PRESS "HOME" TO EXIT MEASUREMENT LOCKED

Standardization with 12 sources (single-channel setting)

The parameter input differs from the single-source routine only in one respect: the question ALL DETECTORS AT ONCE must be answered by YES. Press Space Bar to select "YES" arid then press Return.

*Refer to GAMMA-C12 Operator's Manual, Appendix A, for example of Printout.

-- -- -- - - - - - - - - -

4- 10 60027'7 -04-A Gamma Counter Install and Set-up

The rack display below shows that the rack must contain 12 sources.

: SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE : I I I


I I

7 8 9 10 11 12 I I

I 8 I

I I : SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE :

INSERT TRAY AND PRESS KEY "STARTISTOP" TO START MEASUREMENT

PRESS "HOME" TO EXI?'

Rack display on the screen showing a source in every well

Place a rack containing 12 detectors into the detector block and start the measurement by pressing the button STARTISTOP.

With the preprogrammed channels, the H.V.-Adjust for all detectors is performed first, the efficiency measurement is started automatically.

NOTE: Automatic H.V.-Adjust cannot be performed in the preprogrammed channels, it must therefore be done separately, prior to the standardization

Dual-channel standardization requires measurement of the second isotope after measurement of the first isotope. The standardization is always concluded with the background measurement.

*Refer to GAMMA-C 12 Operator's Manual, Appendix A for example of Printout.

Gamma Counter Install and Set-up 600277-04-A 4-1 1

4.3 Chi-Square Test

General

The Chi-Square Test enables the operator to check the reproducibility of a single detector. First, run a certain number of measurements. Then compare the calculated sum of the squared deviation between the measured and the average count rate with the fluctuations to be expected on the basis of the counting statistics. The calculated value:

must be within certain limits.

In the present program version, the number of repeat measurements is set to 10.

The test may be done with a set of sources and also to check the background. If the measurement is done with uncorrected rates, neither background subtraction or efficiency compensation is performed.

Select the measuring time and the activity of the sample so that at least about 300 counts will be counted and a count rate of 250,000 is not exceeded.

4-12 600277 -04-A Gamma Counter Install and Set-up

Procedure

Select CHI-SQUARE fiom the CALIBRATION OPTIONS menu. The screen displays:

- -

CHI-SQUARE TEST

(1) COMhllENT : Test run

(2) ISOTOPE 1251

(3) MEASUREMENT TIME (MIN): 5 : 000

INPUT ON TH[S PAGE CORRECT?: YES

PRESS SPACE BAR TO SELECT >NO

PRESS "HOME TO EXIT MEASLTREMENT LOCKED

CHI-SQUARE TEST Protocol


( 2 ) Enter up to 15 characters as a comment.

(3) The test can be performed in the preprogramrned channels (1251,57Co).

(4) When selecting the measuring time, please take into consideration the nurrlber of counts and the fact. that the test includes 10 measurements. The total time of the test is therefore about ten times greater than the entered measuring time..


(5 ) Press Return to display rack.

MEASUREMENT PROT. # 63 CHI-SQUARE TEST ISOTOPE: 1251

/ SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE I I , I

1 2 3 4 5 6 f

I I I


9 10

: SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE I I C------------------------------------------------------------------------------------------------------------l

INSERT TRAY AND PRESS KEY "START/STOP" TO START MEASUREMENT


Rack display on the screen showing that a source is to be put into each well

*Refer to GAMMA-C12 Operator's Manual, Appendix A, for example of Printout.

- - - - - -

4-14 600277-04-A Gamma Counter Install and Set-up

4.4 Instrument -QC

This program allows a rapid and simple check of the measuring system, provided a set of matched sources (Iso-measure tubes) is available.

This test checks:

1. The background ratio between the detector with the highest and the detector with the lowest background: this ratio must not exceed the value of 5. The mean of the backg.round ratio is stored. The background measurement is done with uncorrected cpm values.

2. The detector calibration: The differences in efficiency between the detector with the highest and the one with the lowest efficiency, relative to the detector with the lowest efficiency, must not exceed 5%. The mean of the detector calibration is stored.

3. The mean of the lobwest efficiency: this value is also stored. The currently measured value must be within 5% of the stored mean. The efficiency measurement is done with corrected cpm values. For efficiency measurements, the activity of the source has to be between 10,000 and 250,000 cpm.


Procedure

Select INSTRUMENT QC from the CALIBRATION OPTIONS menu. The screen displays:

INSTRUMENT-QC

(1) COMMENT : Test Run

(2) ISOTOPE 1251

(3) MEASUREMENT TIME (MIN) 1 .OW

(4) BKGII. -MEASUREMENT (MIN) 5.000

(5) DPM OF MATCHED SOURCES 220500

(6) RESE,T INSTRUMENT-QC NO

ENTER ANY STRING UP TO 15 CHARACTERS

PRESS "HOME" TO EXIT MEASLTREMENT LOCKED - -

Instrument-QC Protocol

(1) Enter up to 15 characters as a comment.

(2) The test can be performed in the preprogrammed channels (1251,57Co).

(3) Select the measuring time for the efficiency measurement so that high efficiency differences cannot be caused by statistical fluctuations alone. We recommend counting about 40,000 counts, to obtain 2-Sigma of 1 %.

(4) Select the measuring time for the background so that a high background ratio cannot be caused by statistical fluctuations alone. The measuring time should allow that approximately 100 counts are being counted.

(5) The activity of the source must be entered again for each measurement, since the activity of 1251 decreases by approximately 8% and approximately 1.8% for 57Co per week. A false activity simulates an efficiency change.

- ---

4-16 60027'7-04-A Gamma Counter Install and Set-up

(6) Usually this question is answered with NO. If it is confirmed, the RUN- counter is reset and the mean of all previous measurements is deleted. 1251 and 57Co are reset separately.

(7) Press Return to confirm information on page is correct.

MEASUREMENT PROT. # 64 INSTRUMENT QC ISOTOPE 1251

SOURCE SOURCE SOURCE SOURCE SOURCE SOURCE j

I , , I # I I , 8 8

; 7 I I

: SOURCE

C U R R E N T R A C K # I

8 9 10 11 12 I I 8 I I

SOURCE SOURCE SOURCE SOURCE SOURCE ,

INSERT TRAY AND PRElSS KEY "START/STOP" TO START MEASUREMENT


Rack display on the screen showing that a source is to be put into each well

*Refer to GAMMA-C 12 Operator's Manual, Appendix A, for example of Printout.


Chapter 5 GAMMA-C12 GMS Software

5.1 Introduction

GMS is a microcomputer-based program designed for interactive control of the GAMMA-C 12, an instrument designed for the quantitative analysis of the radioactivity of gamma-emitting nuclides. Within GMS is a complete information system. Worklists can be received from an extemal source and have GMS print operator loadlists. After a run, or under user direction, GMS will send results to an extemal source. GMS can check the quality control of the assay system.

GMS uses Microsoft's Windows as an operating environment. The graphical user interface guides the user through the steps needed at all stages of operation. The graphical interface simplifies learning, training, understanding of instrument operation and QC review. Using Windows allow the user to choose those printers, monitors and computers that meet their needs and budget.

5.2 System Requirem~ents

Microcomp~ter caplable of running Microsoft Windows, Intel 80286 or higher microprocessor, operating at a clock speed of 12 MHz or greater.

Minimum of 2 MB of Ram memory.

Hard drive: a disk drive with an average seek time of 28 millisecond or less.

Microsoft MS-DOS or PC-DOS, version or higher and Microsoft Windows 3 .O.

Printer supported by Windows, supporting at least 130 characters per line and graphic printing.

VGA or EGA video, or other video supported by Microsoft Windows.

A monitor that is su~pported by Windows. A color monitor is recommended but not required.

A mouse or pointing device is not required, but strongly recommended.

To connect instruments to GMS, a serial interface is needed for the GAMMA- C 12 and an additional COM2 interface is necessary for the mouse.

Gamma Counter Install and Set-up 600277-05 -A 5-1

5.3 System Set-up

Unpack the GAMMA-C 12 gamma counter, printer and the display terminal. Place all instruments on a level surface and see that all power switches are in the OFF position.

The GAMMA-C 12 requires one serial interface on the microcomputer to connect the instrument; either COMl or COM2 are possible

Depending 011 the co~lnector available on the computer (9 pin or 25 pin), use either the cable LB 75549 or LB 755 17 to connect the GAMMA-C12 to the computer.

Place LB 75547 dum-my RS 232 connector on GAMMA-C12 Printer output.

Connect the GAMMA-C12, display terminal and printer to the wall outlet with the power cords supplied. Turn on the three components of the system. The indicator lights on the printer and the display terminal should be lit as well as the front LED display on the gamma counter. Check to be sure that the printer is ON LINE. The printer should print out SELF-TEST PASSED and MAINS FAILURE.

NOTE: SELF TEST PASSED metins the electronic system has run an automatic self test checking program, peripherals and RAM without detecting an error.

Normally GMS for GAMMA-C 12 comes configured to run the GAMMA-C 12 on COM 1, using its standard serial interface protocol:

8 data bits, 1 stop bit, parity even, 9600 baud, hardware handshake

To change the GAMMA-Cl2 to run in the GMS-mode (computer GMS) or GAMMA-C 12 transmission protocol, open the GAMMA-C 12 housing by removing the stainless steel cover plate (knurled screws to the right and left of the detectors). Then remove the 6 screws (3 on each cover side) to take off the cover. Set the GAMMA-C 12 to computer (GMS) mode by switching DIP- switch S 12 on the board labeled LB 3883-271 to the OFF position (to the left). Invoke the new Dip switch setting by holding down the start button during power up of the GAMMA-C 12.

The GAMMA-C 12 is supplied ready for operation. If the user wishes to work with another mode of operation, the internal DIP-switches will have to be set accordingly.


5.4 Microcomputer Set-up b

Before installing GMS, the user should install Windows according to the Windows installation guide. Make sure to add the directory that was placed to a PATH statement, in the AUTOEXE.BAT file.

If using the COM/4 ox. COM/8 board, follow the instructions in the GAMMA MANAGEMENT SYSTEM Operator's Manual.

Installing GMS requirles the installation of LIMS 4.0 driver and changing of the CONFIG.SYS file. Clonsult the directions enclosed with the LIMS 4.0 driver for this information.

CONFIG.SYS needs changes to handle the number of files required by GMS. A FILES= ## statement must be in CONF1G.SYS. GMS requires the ## be a least 20. If run multiple in~~truments, this number must be larger. As a conservative estimate, the number is 20 times the number of instruments running simultaneously.

A BUFFERS=8 statement should also be added to the CONFIG.SYS files

GMS uses DOS file locking and file sharing to maintain the integrity of the database when multiple instruments run. To use this feature the user must either use GMS on a network that supports these tasks or start the program SHARE.EXE found on the DOS disk before starting GMS. GMS checks for the ability to lock files before starting. If a network is not available, start SHARE from the AUTOEXEC .BAT file

5.5 GMS Installation

Install GMS in its own directory. A suggested name is GMS.

To install GMS, change to the directory created and copy all the files on the supplies disk into that directory.

On the supplied disk are three .EXE programs: LBIS.EXE, LBISETUP.EXE AND WIN87EM.EXE. The last is a Microsoft program that provides support for a coprocessor, if installed. The others are the GMS system programs.

The other files have thle extension .ICD. These files contain the information GMS requires to control the instrument.

- - - - -

Gamma Counter Install and Set-up 600277-05 -A 5-3

5.6 Installing the Digiboard

GMS uses the Digiboard in the supplied default configuration.

5.7 GMS Main Window

GAMMA-C12 [GAMMA-Cl21 " Status: Idle

Toolbar

Run Protocol - operate instruments on line in non-interactive or interactive mode, re-run data, or enter data manually.

Data Transfer - receives worklist or sends results to or from systems external to GMS.

-- - - - - - - - - -


Q.C. - display control or assay Q.C. charts, precision profiles, or result histograms. Also allows the user to enter or change assay specific control parameters.

Edit Protocol -- enter, edit, display, or remove current protocol information.

Std Curve - enters calibrator values or curves, displays overlaid standard curves and creates calibrator curves from them, and removes standard curves from the system.

Gamma Counter Install and Set-up 600277-05-A 5 -5

Services - perform instrument daily or special services, remove assay control values and prepare for a new control lot, save or restore protbcol specific information to a floppy disc, turn off or on the startup logo, and show the current GMS version.

c->GMS - exit from GMS or start another version of GMS. Additional versions of GMS only start i:f an instrument is free.

Control Buttons

Start - tells instrument to start a measuring cycle.

Stop - ends an instrument measurement cycle.

Terminate (Abort) - if the instrument allows multiple tests, the button is Abort. GMS assumes these instruments will automatically signal the change of test over the communication channel. This button should only be used to stop a run in the case of an instrument malfunction. If the button says terminate, press it to signal the GMS that the measurement is complete and the assay should end normally.

Display - shows current run printout. The GMS shares the printer among many windows programs, and can not print results as they calculate. Therefore, all results must print after the last one has been read. If a result is needed before the printout, select display and review the data.


5.8 Assay Protocols

Select any one method for a test. The default method is RIA. A method associated with a protocol can not be changed. The method must first be removed. A protocol creation can be cancelled at any time before assay control definition.

Select EditProtocol, Edit. Type in the name of the protocol required. "Click Select". A box with "Protocol was not found. Make a new Protocol?" comes up. Select OK. Select a p:rotocol method. The default is RIA.

Protocol Methods

Raw Data - creation of raw data file only. GMS does not calculate results.

Ratio - calc~llation of test results based on the ratio of the urhown data to a standard lu~own value.

Cutoff - qualitative and semi-qualitative methods.

Rast - specific IgE.

RIA - single result immunoassay methods.

FTI - Free thyroxine index calculated from T4 and T3.

Spac ET - special method for Spec ET test.

Renin - calculation of plasma renin activity from a low temperature incubated tube.

Receptor - ca1c;ulation of receptor binding proteins using Scatchard and Woolf Plots.

Double RIA - calculation of immunochemical assays where measurement of two analytes occur simultaneously in one tube using two isotopic labels.

Click "OK" afte,r Protocol selection is made.

Gamma Counter Install and Set-up 600277-05-A 5 -7

Instrument setup box appears. Cholose and isotope Ch.A, 57C0, 1251. Enter measurement time. Cllick OK.

Protocol Setup: RIA Data Reduction Method box appears.

Select appropriate Protocol setup parameters which include Assay type, Curve Fit, Quality Control and Extraction Efficiency.

Assay type:

Bound - classic competitive immunoassay measuring the bound fraction.

Free - classic compe:titive immunoassay measuring the free fraction.

IRMA irnrnunometric data reduction for methods using two antibodies and a label on the antibody.

Curve Fit - Spline Auto, Spline, LCF (linear curve fit) auto, linear, quadratic, and cubic.

Quality Control:

None - No assay Q.C. tracked.

Assay Q.C. - allows user to select up to 14 calculation parameter for GMS to track.

Control Q.C. - allows user to track analytellevel specific controls.

Extraction Efficiency - allows user to compare data between two maximum binding (Bo) tubes (extraction vs. non-extraction techniques) and determine the efficiency of the extraction process. The software can also correct patient results for that efficiency.

Click "OK" after all selectio~~s have been made.

Protocol Settings: Replicates/Tube Sequence box appears. Select appropriate Prc~tocol Setting parameters

Total counts - an assay can have from 0-2- total count tubes.

Nonspecific Binding - an as,say can have from 0-20 NSB tubes. An NBS tube must be available before the user can select Patient NSB tubes.

Bo (Maximum binding) - only assays using extraction corrections need Bo tubes.

Standards -one replicate for each standard is required. Up to 20 standards are alllowed.


Pat. NBS -the user can have a patient NSB tube associated with each sample or one common patient NBS tube appearing before all samples.

Unknowns -the user must have a minimum of one and maximum of ten replicates for each unknown.

Number of Sta~ndards - up to nine standards are permitted for any assay. This does not include the NBS or Bo tubes. The following represents the minimum number of standards required for different curve fits.

Polynomial Automatic 2

Polynomial Linear 2

Polynomial Quadratic 4

Polynomial Cubic 5 (6 in automatic mode)

Spline Function 3 (2 if Bo or with IRMA since Bo is available)

Click "OK".

Protocol Settings: Standard Concentrations For Result box appears. Select appropriate Protocol Setting parameters

Concentrations

Standards - values for standards should be entered in ascending order from lowest to highest concentration.

Units - units should be entered manually to be use on report printouts.

Number of Decimal Places Recorded - enter the number of decimal places desired in the final results. GMS will round the calculated value to this number before printing the result.

Thresholds - GMS marks results falling below the low threshold with a "-" and those above the high threshold with a "+". The user can use threshold values to mark results outside a cutoff value, outside a reference range, or outside the measured standard curve. Threshold limits must be set according to one of these three parameters.

Daily Mean - GMS tracks values falling within the low and high values entered here. The user can review a histogram of these values from the QC menu option. This is usually used to track values that fall within or outside the normal range.

Dilution Factor - GMS will multiply results by the dilution factor entered in this field.

Gamma Counter Install and Set-up 600277 -05 -A 5 -9

Result - GMS allows up to three results for certain methods. One must identify the result report by naming the appropriate methods. For single result methods, this field may be left blank.

Click "OK".

Current Controls for "Assay" box appears.

Refer to Quality Control section in GAMMA Management System (GMS) Operator's guide for full explanation and use of Quality Control.

5.9 GMS Maintenance

Continual proper operation of GMS requires that the user perform periodic maintenance on the microcomputer.

GMS files should be backed up regularly. DPC does not provide a system for backup. Many commercial systems exist for rapid backup to other hard disks, magnetic tape units or floppy disks. The only way it can recover from a severe disk failure is by having proper and current backup.

If backup needs to be limited, only backup the DAT and IDX files. All other files can be easily created.

To keep rapid access time, periodically compress the disk using a commercially available program.

Backing up and compressing the disk on a regular basis will allow the user to use GMS without noticeable performance degradation over a long time.

5-10 60027'7 -05 -A Gamma Counter Install and Set-up

Chapter 6 Running the GAMMAXI2

6.1 Procedure

The GAMMA-C2 is a basket instrument that is provided with 12 wells.

When counting tubes, a screen appears with the four control buttons (Start, Stop, Terminate, Display) and an analog clock that shows the amount of counting time left.

To count a basket, place it the GAMMA counter and press Start on either the instrument or the GMS screen.

Once the read has been completed, the instrument sends the data for that basket's tubes to the GMS and a new idle basket replaces the basket that was previously counted. To continue reads, physically replace the counted basket with a new basket of tubes and repeat steps.

Tube identification for the baskets are derived from calibrator and worklist information configured in the assay setup and protocol.

Pressing the Stop button stops data measurement, but does not end the run.

Pressing ~ i s ~ i a ~ shows a copy of the printed report.

Pressing Terminate ends the run and a report prints if it is the final part of the assay. For protocols with two parts, pressing Terminate will switch from the first part to the second.

6.2 Interactive vs. Nona=lnteractive Modes

Basket processing allows for interactive mode of operation. In this mode, data processing will stop after the standard curve calculates to allow the user to review the curve before processing the remaining tubes. If an error is encountered, the curve can be edited to correct the error. The following menu items will appear in the Curve DisplayEdit Window:

Modify - allows user to edit curve data.

Axis - allows user to change axis style to Linear Y/Linear X. Linear Y/Log X or Logit YlLog X.

Abort Run - allows user to abort run if the standard curve is bad.

Exit - end stanclard curve review and continue data processing.

Gamma Counter Install and Set-up 600277-06-A 6- 1

6.3 Error Handling

Non-fatal errors - GMS displays information in the upper right portion of the main menu and the instrument beeps whenever it receives data and a non-fatal error condition exists. Associated iwith the error is a command the GMS sends to the instrument to try to fix the error. This persists until the run stops or until the ii~strument tells the GMS it is fixed..

Fatal errors - The irlstrument sencis this error when it finds conditions that prevents further data processing. The screen will turn to the Idle State, the error information is displayed as text, and the GMS beeps every two seconds until the error is corrected. Finally, the GMS will abort the run when this type of error is encountered.


Chapter 7 Maintenance

7.1 H.V. Adjust

For optimum performance H.V. Adjust shou.ld be performed weekly for singly labeled assays and daily for dual-labeled assays. Follow the procedure outlined in Chapter 4, Calibration Options.

7.2 Standardization

For optimum performance Standardization should be performed monthly or as indicated by the instrument QC. Follow the procedure outlined in Chapter 4, Calibration Options.

7.3 Air filter

Once a month, remove the grid on the front panel of the instrument by pressing lightly on the two locking buttons with a ball point pen, a small screw-driver or another rather blunt tool. Clean the filter by knocking out the dirt, blowing it out or washing it. If necessary, replace it with a new filter, DPC catalog number BERT1 341 9. When reinstalling the grid, make sure it fits properly. Secure it by pushing in on the locking buttons.

7.4 Decontamination

Remove the stainless steel cover plate. Take off and clean (if necessary, replace) the plastic insets in the wells serving as contamination protection.

Clean the detectors thoroughly using a damp (but not wet) cloth, clear water and if necessary, a liquid detergent.

DO NOT USE ALKALINE OR ACIDIC SOLUTIONS.

UNDER NO CIRCUMSTANCES POUR LIQUIDS OF ANY KIND INTO THE DETECTOR - SEVERE DAMAGE MAY RESULT.

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Chapter 8 Troubleshooting

Problem

Fails "Daily QC" check

Detector fails HV Adjust

Detector fails HV Adjust during Standardization, or fails detector balancing

I

Well-liner contaminated

Possible Cause

Voltage needs adjustment

Detectors need efficiency balancing or adjustment

Hard-problem with one or more detectors

Each isotope must be standardized to enable any detectors.

Ngh background counts in one or more detectors

Remove tray and count background with a raw data program. Contaminated trays must be washed thoroughly in a mild soap solution and counted again for high background count.

- - - -

Resolution

Run High voltage (HV) Adjust under Instrument Services

Standardization isotope (usually 1251). For customers running dual count standardize the 125I/57Co isotope

Instrument requires on-site service or depot service. Disable any problem detectors and continue using instrument.

Counting tray contaminated

Remove well liner for problem detector(s) and count backgrounds. Contaminated well liners must be washed in a mild soap solution. Thoroughly dry the well liners before

I re-installing. Check background counts

I 1 I again before use. I Contaminated detectors WARNING: Do not use alkaline or

acid solutions in detectors, and never pour any liquid of any kind in detectors. Clean contaminated detector(s) with a damp cloth. (Dampen cloth with DI water only.) Allow the detector to dry thoroughly before installing well liners. Check background counts before use.

1 Electronic noise Standardize instruments. After standardization count background again. If problem persists operator should disable problem detector(s). Instrument requires on-site service or depot service.

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Problem

System reports "SELF TEST FAILED" when powered up.

Unable to count with PC- system or Televideo not responding on terminal system or menu won't go "Home"

Red LED remains on

Possible Cause

Interrupted power supply

Communication problem between Televideo or PC and1 gamma counter

Printer off or off-line

Undetermined cornmunication prloblem

Communication between Televideo or PC and instrument

Resolution

Turn entire system off. Power system back up while holding "Stai-t" button down for 20 seconds after power-up. Terminal systems must be standardized after system re-set.

Check and secure cables on Televideo or PC and terminal port on back of instrument

Turn on printer. Press on-line button

Exit software if possible and turn entire system off. Power system back up while holding "Start" button down for 20 seconds after power-up. Terminal systems must be Standardized after system re-set.

Check and secure cables.


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