Beruflich Dokumente
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DOSE CALIBRATOR
OPERATION AND SERVICE MANUAL
VERSION 2.1
086-250
086-258
BIODEX
Biodex Medical Systems, Inc.
20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: sales@biodex.com, www.biodex.com
NOTE: Prior to making activity measurements after a preset Dial Value has been
changed on ANY isotope selection key, all Atomlab model Dose Calibrators must
be power cycled; i.e., the Dose Calibrator power switch must be turned OFF and
then back ON. Failure to power cycle after changing any preset key may cause a
measurement ERROR on any or all isotope keys.
B. This warranty does not apply if the product, as determined by BIODEX MEDICAL
SYSTEMS, INC., is defective due to abuse, misuse, modification or service performed by
other than a BIODEX MEDICAL SYSTEMS, INC. authorized repair and calibration facility.
Misuse and abuse include, but are not limited to, subjecting limits and allowing the
equipment to become contaminated by radioactive materials.
C. In order to obtain warranty repair service, the equipment must be returned freight pre-
paid to one of our facilities. The Return Authorization number (R.A. #) should be included,
along with a statement of the problem. Equipment will be returned transportation prepaid.
2. Calibration
A. Instruments are warranted to be within their specified accuracy at the time of shipment.
If a question arises and BIODEX MEDICAL SYSTEMS, INC. determines that the initial cali-
bration is in error, the instrument will be recalibrated at no charge.
B. Mechanical products are warranted to meet written specifications and tolerances at the
time of shipment.
4. Non-Warranty Service
A. Repairs and/or replacements not covered by this warranty may be performed by
BIODEX MEDICAL SYSTEMS, INC. at a factory authorized service location. Estimates of
repair charges may be requested, however, a charge for estimate preparation may apply if
the repair is later not authorized by the customer.
B. The cost of transportation into and out of the service location will be the responsibility of
of the customer.
BIODEX
Biodex Medical Systems, Inc.
20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: sales@biodex.com, www.biodex.com
If you still think you have a service problem, call BIODEX MEDICAL SYSTEMS, INC.,
Service Department at (800) 224-6339.
2. After taking the information, we will advise on the action we will take.
3. Sometimes service personnel must consult with engineering and it may take time to get
back to you. Be sure to let the service representative know your schedule so that we
can call at a convenient time.
4. The return call may be from a person other than whom you first reported the problem to.
5. After analyzing the problem, we will decide if the unit must be returned to us for repair,
or replacement parts will be sent.
6. If unit must be returned, it will be given a return authorization (R.A. #) number by us.
Pack the system in the carton that it was originally shipped in, or pack it safely and
securely to avoid shipping damage. It is the customer's responsibility for any damage
that occurs during shipping.
BIODEX
Biodex Medical Systems, Inc.
20 Ramsay Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: sales@biodex.com, www.biodex.com
PACKING SLIP
• DISPLAY UNIT
• DETECTOR UNIT
The DISPLAY In addition to the Display Unit itself, this carton contains the
UNIT Carton: Atomlab's Operation Manual, all the necessary connection
and power wires needed to run the system, and a Moly
Assay Kit. A Report of Calibration can be found in the
Instruction Manual's front, inside pocket.
TABLE OF CONTENTS
Page
Chapter One: Introduction to the Atomlab Dose Calibrator.........................1-1
Introduction to the Atomlab Dose Calibrators and this manual.
Chapter Two: Installing Your Dose Calibrator ...............................................2-1
Describes what you need to properly use your Atomlab Dose Calibrator,
powering up, installation, and cleaning instructions.
Chapter Three: Getting Started .......................................................................3-1
This chapter allows you to gain a quick familiarization of the operation of
your Dose Calibrator.
Chapter Four: Description ...............................................................................4-1
Describes features and functions of your Dose Calibrator, including the
Detector and Display units.
Chapter Five: Operation...................................................................................5-1
Describes the full operation of your Atomlab 100 Dose Calibrator
Glossary
Appendices
Appendix A
Atomlab Dose Calibrator Troubleshooting Procedures ................................A-1
Appendix B
Atomlab 100 Dose Calibrator Specifications ................................................B-1
Appendix C
Decay Calculations .......................................................................................C-1
Appendix D
Pre-Set Calibration Values............................................................................D-1
Appendix E
Calibration Values for Version Six Firmware Other Isotope Selections........E-1
(Includes Setting Information for Y-90)
Appendix F
Atomlab Dose Calibrator Calibration and Traceability ..................................F-1
Appendix G
Atomlab Computer Interconnection ..............................................................G-1
Appendix H
Electromagnetic Compatibility ......................................................................H-1
Appendix I
Determining The Firmware Level of Your Dose Calibrator ............................I-1
Appendix J
Quality Assurance Testing of Atomlab Dose Calibrators...............................J-1
Schematics
Atomlab Dose Calibrator Quick Reference Chart
Atomlab Dose Calibrator Trouble-Shooting Chart
CHAPTER ONE:
INTRODUCTION TO THE
ATOMLAB 100 DOSE CALIBRATOR
OVERVIEW
CHAPTER TWO:
INSTALLING YOUR ATOMLAB 100 DOSE CALIBRATOR
OVERVIEW
OPERATING REQUIREMENTS
The surface area of the table top should provide ample area
to accommodate the Detector Unit, Display Unit, the Printer,
the L-Block Shield, the shielded radionuclide preparation
area, and room for writing. See Figure 2-1 for a typical dose
preparation layout.
• 30 in. deep
• 48 in. wide
• 36 in. high
In general, make sure your work area is clean, dry, and dust
free.
POWER REQUIREMENTS
Line Voltage 100 to 120 VAC 1/2 A, or 200 to 240 VAC 1/4 A, selectable
with Fuse Holder (see Appendix A).
POSITIONING
CABLE CONNECTIONS
Detector Unit Refer to Figure 2-2 for an illustration of the Detector Unit's
Connection cable connector and rear panel. The Detector Cable is gray,
ten feet long, and has white identical male connectors on
both ends. The connectors are of a self-locking type.
Figure 2-2: The Rear Panel of the Detector Unit, end of the
Detector Cable, and the Operational Light.
Figure 2-3: The rear panel of the Display Unit with Chamber
Connector, the end of the Detector Cable, and the Display
Power Cord end of the Power Cord.
Connection
1) Rotate the Display Unit so that you are looking at the
rear panel. Directly to the right of the connector labeled
CHAMBER, locate the Fuse Holder. This is labeled USE
ONLY WITH 250V FUSES, with 100-120 read upright,
and 200-240 read upside down.
POWERING UP
PACKING MATERIAL
Now that you have set up your Atomlab Dose Calibrator, and
everything is intact and functioning properly, take a few
moments to repack the packing material. This material was
especially designed for safe shipment of the Atomlab Dose
Calibrator and should be considered part of the instrument.
Place the shipping material in the appropriate boxes and put
the boxes back into the shipping carton. Label the carton and
store it in a safe, out-of-the-way location. If you ever need to
return your dose calibrator for updates, calibration, or repair,
use the original shipping carton, boxes, and shipping material.
CHAPTER THREE:
GETTING STARTED WITH YOUR
ATOMLAB 100 DOSE CALIBRATOR
OVERVIEW
METHODOLOGY
Front Panel Refer to the Front Panel Display illustrated in Figure 3-1. On
Display the Atomlab 100, the unlabeled key to the right of the ⇑⇓ on
the Electronic Thumbwheel is referred to as the ENTER key.
The 4-digit display associated with the Electronic
Thumbwheel is referred to as the Electronic Thumbwheel
Display. See Chapter 4 for details.
GETTING STARTED
Power-up If you have not done so already, reach behind the Display
Unit and flip up the power switch from the left position (0) to
the right (-) to power up your system. The TEST key LED
will illuminate and the Atomlab will automatically initiate a
Self-Test program.
Read the Display NOTE: The top right four-digit LED Activity Display always
indicates activity in the Detector's Chamber Well, no matter
which keys are pressed. (There are momentary exceptions:
when you press the TEST key, for example.)
NOTE: The Mo-99 key has a special function for the Moly
Breakthrough test, which is described in Chapters 4 and 5.
AVERAGING PERIOD
RANGE SELECTION
ISOTOPE SELECTION
DISPLAY UNITS
Changing To change the Atomlab 100 Display Units, press the SETUP
Display Units key and observe its LED come ON. This indicates the
Atomlab 100 is in Setup mode. Observe that the unit indica-
tor to the right of the Activity Display (for example, µCi) is
blinking at the same rate as the LED on the OTHER key.
Press the OTHER key and see that the other system of units
(MBq) is now displayed and the displayed activity value has
been corrected in accordance with this new system of units.
CHAPTER FOUR:
ATOMLAB 100 DOSE CALIBRATOR DESCRIPTION
OVERVIEW
GENERAL DESCRIPTION
THE DETECTOR
THE CHAMBER
CURRENT MEASUREMENT
REAR PANEL
RESPONSE
ZERO CALIBRATION
DISPLAY UNITS
For example, 12.03 µCi = .445 MBq and 63.9 mCi = 2.36
GBq. If the numeric display reads 0.445 and MBq is indicat-
ed, the activity value is 445,000 Becquerels; if 2.36 is dis-
played and GBq indicated, the activity is 2,360,000,000
Becquerels.
Activity Display The four-digit LEDs which make up the Activity Display always
display measured activity, except during the Self-Test.
To the right of the Activity Display are the four display unit indi-
cators: µCi, mCi, MBq, and GBq. If you select Ci as the display
units, the LED behind either µCi or mCi will come ON, depend-
ing on the range automatically selected by the Atomlab Dose
Calibrator; if you select Bq, MBq or GBq will be indicated.
Isotope Selection These keys allow you to select which radioisotope you will
Keys be measuring. When, for example, you press the key
marked Tc-99m, the dose calibrator will be calibrated to
accurately measure the activity of Tc-99m. The LED on the
key you press will come ON so that you will always know for
which radioisotope the system is currently calibrated.
User-Defined The keys labeled 1, 2 and OTHER allow you to display activity
Keys values for non-standard radioisotopes. The 1 and 2 keys are
programmable, eliminating the need to constantly set the
Calibration Values for any non-standard radioisotope you
constantly measure, while the OTHER key allows you to set
up the dose calibrator for a particular radioisotope at the time
of measurement (its default setting can be modified as well).
After 4 seconds, this display will turn OFF and the next
test given in 2) will occur.
8.8.8.8.
Background When you press the BKGND key to store the background
Correction activity, this value remains in memory until you press the
(BKGND Key) key again. Pressing the BKGND key a second time will abort
the process.
SETUP MODE
Setup Key
Pressing the SETUP key accesses the Setup mode. At this
point you may change the dial value settings. To change
other setup parameters once in Setup mode:
ELECTRONIC THUMBWHEEL
CHAPTER FIVE:
OPERATION OF YOUR ATOMLAB 100
DOSE CALIBRATOR
At this point, make sure you have performed the steps de-
scribed in Chapters 2 and 3 and are familiar with Chapter 4.
DAILY CHECKS
1) With the Atomlab turned OFF, turn the switch box dial to
chamber one.
2) Reach behind the display unit and flip the Power Switch to the
ON position. Allow the unit to complete the standard Self-Test.
5) Using the ETD ⇑ and ⇓ arrow keys, enter the total number
of chambers connected to the display.
8) Turn the switch box dial to the next chamber (#2) and repeat
steps three through seven. Do this for each chamber connect-
ed to the display.
11) Set the switch box to chamber one and turn the system
back ON. After approximately 20 seconds the display unit
will emit a “beep,” the ENTER key will begin to flash and the
prompt “CH-1” will again appear in the ETD.
12) Press the flashing ENTER key and allow the Self-Test to
proceed. When the Self-Test is complete chamber one will
be fully initialized.
13) Set the switch box to chamber two. Turn the Atomlab
OFF. Wait five seconds and turn it back ON.
14) At the “beep” use the ETD ⇑ and ⇓ arrow keys to incre-
ment the ETD value so that it matches the switch box setting.
15) Press the flashing ENTER key and allow the Self-Test to
proceed. When the Self-Test is complete the chamber will be
fully initialized.
16) Turn the Atomlab OFF. Set the switch box dial to the next
chamber and turn the system back ON. Repeat steps 14 to
16 for each additional chamber.
Background
Correction Ensure the Chamber Well Liner and Sample Holder have
been placed into the Chamber Well. Press BKGND.
Press the Cs-137 key. The Activity Display will now show
the activity of your Cs-137 check source.
The test method has been derived from the fact when
Mo-99 decays, high energy gamma photons (~750 keV)
are produced which can "breakthrough" a lead wall with a
thickness sufficient to totally absorb the lower energy
Tc-99m gamma. Therefore, when a Tc-99m source is placed
in a properly shielded lead container and inserted into the
Chamber Well of the Atomlab 100, any measured radiation
will be due to Mo-99 gamma transmission.
1) Insert empty Moly Shield and press the Mo-99 key. The
Electronic Thumbwheel Display will begin a 30-second
countdown.
A = Aoe – In(2)(t/T1/2)
where t = time lapse since calibration and T1/2 = half life
Ao = (1.195 MBq/g)(4.95863 g)
= 5.926 MBq
= 160.2 µCi
t = 60.25 days
A = 160.2 e – In(2)(60.25/59.6)
= 79.5 µCi (2.94 MBq)
NOTE: Should you find that you never use one or more of
the standard Isotope Selection keys, you may use the proce-
dure above to reset them for a radioisotope you do frequent-
ly measure. However, you must identify or mark the key with
the isotope for which it is programmed.
1) Press the SETUP key. The SETUP LED comes ON. The
OTHER key LED begins to flash indicating you may
select the OTHER display units if desired.
2) Press the key labeled 1 (or 2). The 1 (or 2) LED comes
ON.
Checking the From time to time you may wish to check the Calibration
Standard Keys Values of the standard Isotope Selection keys. With Appendix
D before you, press SETUP and then press the standard
Isotope Selection keys, comparing the settings on the
Electronic Thumbwheel Display with values in the appendix.
Pressing SETUP again takes you out of Setup mode.
GLOSSARY
OVERVIEW
Accuracy Tests The test of a dose calibrator to see how close the displayed
activity values are to the true values.
Averaging Period The time the Atomlab takes to display a stable activity
reading.
Calibration Value The value set on the Electronic Thumbwheel (#1) Display to
adjust the Atomlab to correctly respond to a particular
radioisotope. See Response, Ionization Chamber.
Decay Chart A chart projecting how the activity of a source will decay
over a period of time at specified time intervals.
Molybdenum-99 The parent radionuclide which decays into the daughter Tc-
(Mo-99) 99m, used to generate radiopharmaceuticals.
APPENDIX A:
ATOMLAB DOSE CALIBRATOR TROUBLE-SHOOTING
PROCEDURES
OVERVIEW
PROBLEM DESCRIPTIONS
Procedure 1) Turn the Power Switch OFF for several seconds, then
switch it back ON.
2) Turn the power OFF again and remove the Power Cord
from the electrical outlet. Remove the other end of the
Power Cord from the receptacle on the rear of the
Display Unit.
4) Turn the power OFF, remove the Power Cord from the
outlet and verify that the voltage of the outlet is correct.
If not, repair the outlet or find another outlet that
provides the required voltage. Re-insert the Power Cord
and turn the power back ON.
5) Turn the power OFF, remove the Power Cord from the
outlet and remove the Fuse Holder, as described later in
this appendix (see Figure A-1). Verify that both fuses are
intact. If one or both are not, replace. Re-insert the Fuse
Holder into the rear panel of the Display Unit. Re-insert the
Power Cord into the outlet and turn the power back ON.
If your system still will not power up, call the Biodex
Customer Service Department.
After you insert an isotope into the Detector and select the
properly calibrated key, the display may vary at low activity
values as the system acquires the new data. After a short
time the Activity Display will stabilize, with expected fluctua-
tions described below. If the display continues to fluctuate,
and you have verified it is not because of a high Calibration
Value, consult Biodex Customer Service Department.
Display Fluctua- For some isotopes which require a high Calibration Value,
tions For High you may observe fluctuations of ±0.5 µCi or more. Keep in
Calibration mind that the Calibration Value for an Isotope is related to
Values gain of the electrometer, or by what factor the electrometer
has to amplify the signal from the detector. The Calibration
for Tc-99m is 33.6, and a reading of 10 µCi for Tc-99m is
equivalent to 10-12 Amps measured by the electrometer.
High Calibration Values impact gains so that the electrome-
ter amplifies inherent noise to a greater degree. Thus,
greater fluctuations are observed in the Activity Display.
For instance, the Calibration Value for Co-60 is 5.0. The fluctua-
tion due to noise probably would not be noticeable (±0.01 µCi).
The fluctuation due to noise for Tc-99m (33.6) is approximately
±0.05 µCi. For an isotope requiring a Calibration Value of 500
(for P-32 it is 632) the fluctuation will be ±0.5 µCi or more.
UNEXPECTED READINGS
1) Press SETUP.
Fuse Inspection Once the Fuse Holder is removed, inspect the filament at the
center of the two fuses. If it is burned or broken in any way the
fuse must be replaced. If the filament does not appear to be
broken or burned, test the fuse for continuity with an ohm
meter.
After you have reached the last error message, press the
TEST key once more. If one or more of the Error Messages
still persist, refer to Appendix A or the Atomlab Dose
Calibrator Trouble-shooting Guide provided with this manual.
NOTE: For certain error fault you can press the TEST key
and continue to use your dose calibrator. The LED on the
TEST key will continue to flash, reminding you that action to
correct the problem must eventually be taken. Some of
these faults can be easily corrected over the phone by the
Biodex Customer Service Department. Other faults, howev-
er, require that you return the dose calibrator to Biodex
Medical Systems for servicing.
APPENDIX B
Atomlab 100 Dose Calibrator Specifications
OVERVIEW
This appendix provides the physical and operating specifi-
cations of your Atomlab 100 Dose Calibrator.
MEASUREMENT RANGE
For Tc-99m, 0.01 µCi to 9999 mCi, auto-ranging.
DISPLAY RANGES
Units are user selectable:
Ci Bq
RESPONSE TIME
Auto selection:
one second above 2 mCi;
three seconds between 200 µCi and 2 mCi;
three to 30 seconds below 200 µCi.
ACCURACY
Overall accuracy of activity determination for specific front
panel isotopes using the factory set Calibration Values is
within 3% or 0.3 µCi, whichever is greater.
Stability Short term (24 hours): within 0.3% above one mCi,
exclusive of background.
Long term (one year): within 1%.
NOISE
Display Fluctuations Activity Range
ENERGY RANGE
25 keV to 3 MeV
ISOTOPE SELECTION
Ten preset Keys: Co-57, Cs-137, I-131, In-111, Ga-
67, Xe-133, I-123, Tl-201, Mo-99, and Tc-99m.
DETECTOR TYPE
Well-type pressurized ionization chamber, with Argon filled
gas. Replaceable plastic liner included. Dimensions are:
Detector Shield .25 in. (6 mm) lead surrounding ionization chamber, with top
well opening.
PHYSICAL DATA
Display Unit Detector Unit
DETECTOR CABLE
Length 10 ft. (3.1 m)
Conductors Six total: two for power, one for chassis ground, three for serial
data.
Connectors AMP Mate-n-Lock, white with hooded strain relief.
FRONT PANEL
Activity Display Four digit, seven segment red LED, 0.57 in. (14.5 mm)
high, four floating decimal point indicators between digits.
Activity Units Four discrete inscriptions back lit with large red LEDs: mCi,
µCi, MBq or GBq (right adjacent to digits).
All Keys Momentary contact, rubber with conductive pad.
Other Isotope Key OTHER, 1, and 2: allows activity display of other isotopes. In
Setup mode the OTHER key selects units.
Electronic Four digit, seven segment red LED, 0.27 in. (6.9 mm) high,
Thumbwheel with colon between second and third digits, and three float-
ing LED decimal point indicators between digits.
Control Function The ENTER key (to the right of the Electronic Thumbwheel
Keys Display) programs the Calibration Value to correspond with
the selected isotope key.
Line Voltage 100 to 120 VAC 1/2 A, or 200 to 240 VAC 1/4 A, selectable
with Fuse Holder (See Appendix A).
ETL Listed
Electrical Equipment, Laboratory Use;
Part 1, General Requirements for Safety conforms to
UL STD 3101-1, conforms to EN 6010-1,
EN 60601-1-1
NOTE:
Authorized European Community Representative: Prothia, Paris, France
0413
98-131
APPENDIX C:
DECAY CALCULATIONS
OVERVIEW
This appendix provides methods of performing radioisotope
decay calculations.
4) Calculate A = A0 x 2(-t/T1/2)
1) A0 = 43 mCi.
4) A = A0 x 2(-t/T1/2)
A = 43 mCi x 2(-0.8833/6.007)
A = 43 mCi x 2(-0.147045)
A = 43 mCi x 0.903
A = 38.83 mCi
1) Ai = 43 mCi.
3) t = 32.5 h.
6) From the Decay Factor Chart, the .41 row and the .001
column, Xr (.410) = .75262.
N Xn (N) = 2 -N
0 1
1 0.5
2 0.25
3 0.125
4 0.0625
5 0.03125
6 0.01563
7 0.007813
8 0.003906
9 0.001953
10 0.000977
Table 1
Af = Ai e-λt
where
where
Af = X Ai
where
X = Xn (N) x Xr (R)
e(A + B) = eA x eB ;
eln(A) = A ; and
eAB = (eA)B .
Now t / T1/2 = N + R
= Ai x Xn (N) x Xr (R)
Xn (5) = 0.03125
Xr (0.410) = 0.75262
Af = X Ai = [Xn (N) x Xr (R)] Ai = [0.03125 x 0.75262] 43 mCi
Af = 1.01 mCi
APPENDIX D
ATOMLAB DOSE CALIBRATOR PRE-SET
CALIBRATION VALUES
OVERVIEW
Chart A
(For Chamber Units with level six or higher firmware only.)
Chart B
(For Chamber Units with firmware level five or less.)
APPENDIX E:
CALIBRATION VALUES
FOR VERSION SIX FIRMWARE OTHER ISOTOPE
SELECTIONS
OVERVIEW
NOTE: For all Dose Calibrator Models, the well liner must
be installed before making measurements. The well liner
provides attenuation for the Y-90 betas that would otherwise
enter the chamber and cause high readings.
APPENDIX F
ATOMLAB DOSE CALIBRATOR CALIBRATION
AND TRACEABILITY
APPENDIX G:
ATOMLAB COMPUTER INTERCONNECTION
PC PORT COMMUNICATIONS
Command
During a self-test sequence, i.e., the TEST key was pressed, all
characters are ignored, including the six PC port commands.
The first field starts with the first character after the title and
Dose Calibrator
Records continues until a space is encountered. It may be from two till
six characters in length. There are thirteen isotope names.
Typical sample records are shown below (version 5 firmware):
Atomlab 100
~Tc-99m 31.5 2.54 µCi
~Mo-99 179. 25.6 mCi
~Tl-201 18.0 14.0 MBq
~I-123 14.4 19.5 GBq
~Xe-133 19.6 1.57 µCi
~Ga-67 28.0 2.24 µCi
~In-111 13.5 -1.08 µCi
~I-131 22.6 1.80 µCi
~Cs-137 17.3 1.37 µCi
~Co-57 27.0 2.15 µCi
~#2 278. 22.3 µCi
~#1 5.0 0.40 µCi
~OTHER 7.7 -0.61 µCi
The second field is the dial value that is being used to cal-
culate activity. The third field is the numerical value of activi-
ty. This number may be positive or negative. The fourth and
last field is the units of activity. They will be µCi, mCi, MBq
or GBq. The final character is the end of record character as
described above.
ADDITIONAL CONTROLS
Code Isotope
A Tc-99m
B Mo-99
C Tl-201
D I-123
E Xe-133
F Ga-67
G In-111
H I-131
I Cs-137
J Co-57
K #2
L #1
M OTHER
N SETUP
O TEST
P BKGND
Q N/A
R N/A
S N/A
T Unlabeled
U N/A
V N/A
W Up Arrow ETW#1
X Dn Arrow ETW#1
Y N/A
Z N/A
[ N/A
\ N/A
APPENDIX H:
ELECTROMAGNETIC COMPATIBILITY
H-2
IEC 61000-4-6 Conducted Immunity, 150 KHz to 80 MHz /3Vrms no degradation of performance complied
Power Leads
IEC 61000-4-8 Magnetic Immunity 3A/M RMS @ 50/60 Hz no degradation of performance complied
IEC 61000-4-11 Voltage Dips and Interrupts Int Pause % no degradation of performance complied
Duration between reduction
Int 20msec pause 10 sec >95% no degradation of performance complied
Int 100msec pause 10 sec 60% no degradation of performance complied
Int 500msec pause 10 sec 30% no degradation of performance complied
Int 5000msec pause 10 sec >95% no degradation of performance complied
CISPR 11 Conducted Emissions 150 KHZ-30 MHz, Class A, Group 1 79/73 dbuV QP complied
66/60 dbuV AV
CISPR 11 Radiated Emissions 30 MHz – 1GHz, Class A, Group 1 40/47 dbuVm @ 10 m complied
IEC 61000-4-5 Surge Immunity, 1 Kv, differential, 2 Kv Commons no degradation of performance complied
Power Leads Pos, Neg
Date: 3/8/05
Atomlab\Rick Prince - dc methods test.doc :cs:dv
Release 2.0
Appendix H
ATOMLAB Dose Calibrator Operation Manual Appendix I
APPENDIX I:
DETERMINING THE FIRMWARE LEVEL OF
YOUR DOSE CALIBRATOR
Constancy
Constancy means reproducibility in mea- 1 Press the Background (Bkgnd) button. exceeds the tolerance, make correc-
suring the same source, over a period of When the display zeroes, the unit has tions2 to all future measurements.
time, with decay correction. automatically adjusted for Background. 5 Repair or replace the dose calibrator if
Assay a relatively long-lived source (such as 2 Assay each reference source using the the error exceeds ten percent (10%.)
Cs-137) each day before using the appropriate dose calibrator setting (i.e.,
calibrator. use the Cs-137 setting to assay Cs-137.) 1. Tolerance Limits: Determine the tolerance limits
Cs-137, 100 µcuries, is strongly recom- 3 Record the activity reading of the con- from: Low Limit = 0.95 x INITIAL; High Limit =
mended because the 30-year half life will stancy source in a permanent log that 1.05 x INITIAL, where INITIAL = the average of
the first two weeks of constancy measurements. In
assure use of the same source throughout has limits or tolerance bars1. the log, decay the tolerance limits and INITIAL val-
the life of the calibrator, and it is readily 4 Compare the measurement with the ue using half life of the isotope (Cs-137, 30 years).
available. allowed tolerance. If the measurement 2. Correction resulting from constancy error: Cor-
Consider using the following procedure or rected measurement = Measurement x (INITIAL/
ACTUAL) Constancy Record.
equivalent:
Dial Value Settings and Source Containers (Glass Vial, Glass Syringe, etc.)
The Atomlab Dial Value (DV) settings procedure. During following steps, set DV Container with source material
enable the software to convert ion cham- to the Atomlab published value. 1 Assay Container with the isotope source
ber current into a displayed activity value material, record as (Container Activity)1.
for the isotope corresponding to the DV Container with no source material
selected. The displayed activity value is 1 Assay a quantity of isotope source mate- 2 Transfer part or all of the source mate-
directly proportional to the DV. rial in a plastic syringe, nominal wall rial from the Container into a plastic
thickness of 1mm, record as (Plastic syringe, nominal wall thickness of 1mm.
The isotope’s “source container” is either a
vial or syringe; the composition of the vial Syringe Activity)1. 3 Assay the plastic syringe with the iso-
or syringe MAY influence the accuracy of 2 Transfer part or all of the source mate- tope source material, record as (Plastic
the activity measurement. The DV supplied rial from the plastic syringe into the Syringe Activity).
in the Atomlab User Guide (Instruction empty Container. 4 Assay the partial or “empty” Container
Manual), or pre-programmed into the front 3 Assay the Container with the isotope for residual activity, record as (Container
panel isotope keys, are calibrated for use source material, record as (Container Activity)2.
with the source material in an un-shielded plas- Activity). 5 Calculate the Container Dial Value for
tic syringe (nominal 1mm wall), while 4 Assay the partial or “empty” plastic use with isotope assayed,
hanging in the supplied “source dipper”
syringe for residual activity, record as
syringe support. For isotopes contained in ( PSA )
CDV = DV ⋅ ------------------------------------ ,
(Plastic Syringe Activity)2.
sealed long lived QA sources (Cs-137, etc.), ( CA ) 1 – ( CA ) 2
the DV supplied are calibrated for use with 5 Calculate the Container Dial Value for
type Vial E epoxy sources or equivalent. use with isotope assayed in that type of where PSA = Plastic Syringe Activity and
container, CA = Container Activity.
Accurate measurement of unsealed
sources in any other configuration must be ( PSA ) 1 – ( PSA ) 2 Typically, for glass wall source Containers,
with a new Container Dial Value “CDV”, CDV = DV ⋅ ------------------------------------------------- , CDV will be higher than DV when the iso-
( Container Activity ) tope has a significant portion of low
determined by the USER with the following
where PSA = Plastic Syringe Activity. energy photons in its emission spectrum.
*Manufactured by Sun Nuclear Corporation, Melbourne, FL; distributed by Biodex Medical Systems.
July 8, 2004 P/N 107012 Rev. B; © 2004, Sun Nuclear Corp. page 1 of 4
Linearity
Linearity means the proportionality of the the first assay. Decay-correct each dis- acceptable range and if the 1st linearity test
measurement result to the activity mea- played activity measurement (M) using by decay produced acceptable cfM values at
sured, as determined over the intended the equation, higher M values, then the dose calibrator
range of use for the dose calibrator. t - passes. The two linearity tests should have
---------
This test is done using a vial or syringe of T1 ⁄ 2 overlapping activity values in the acceptable
Tc-99m whose activity is at least as large as M0 = M ⋅ ( 2 ) ,
range.3 Hint: Recalculate first test ( M 0 )
the maximum activity normally assayed in
where T1/2 = 6.007 h. Record the values. without including failing values from low
a prepared radio pharmaceutical kit, in a
See linearity form, Figure 1. Calculate (M) Mo-99 contamination.
unit dosage syringe, or in a radio pharma-
activity correction factors (cf) by divid-
ceutical therapy, whichever is largest. 5 If cfM < 0.90 or > 1.10, contact Biodex
ing the average of all decay corrected
Decay method measurements ( M 0 ) by each M0, i.e., technical support and provide full
details, including all linearity decay
1 Zero the Background by pressing the Average of all M data.
Background (Bkgnd) button. cfM = ------------------------------------------0- .
M0 ( t ) 6 Put a sticker on the dose calibrator that
2 Assay the Tc-99m syringe or vial in the says when the next linearity test is due.
dose calibrator to obtain the activity. Accept if 0.95 < cfM < 1.05. Consider
This first assay should be done in the correcting the displayed activity mea- Shield method
morning at a convenient time, for exam- surement (M) of radio pharmaceuticals if If you decide to use a set of “sleeves” of
ple, 8 A.M. a linearity error is greater than ± 5% and various thicknesses or combination of
3 Repeat steps 1 and 2 at about noon and less than ± 10%, i.e., 0.90 < cfM < 0.95 sleeves to test for linearity, it will be nec-
again at about 4 P.M. Continue on sub- or 1.05 < cfM < 1.10. Corrected M = M essary to first use the Decay Method to
sequent days until the displayed activity * cfM where subscript M is closest in show the calibrator is linear. Then follow
is ten (10) microcuries or less. If the dis- value to M in most recent linearity form. the directions furnished with your lead
play indicates less than 50 µCi, (1.85 For low activity values, if cfM < 0.95 see sleeves (i.e. Lineator instructions.)
MBq), wait 30 seconds before recording the following note about Mo-99
contamination. If failure occurs at the low activities, check
the display. Or, press the Mo-99 key on
for Mo-99 contamination by repeating the
the AtomLab panel and then the Tc-99m NOTE: If there is any Mo-99 contaminant in test with 1 mCi. See Note under “Decay
key to get a faster reading. Record the the Tc-99m sample, then long decay tines Method,” step 5.
date, time (to the nearest minute), and (>48h) will compromise the decay linearity
activity. test. This will be apparent with decreasing
NOTE: Use of a spreadsheet, such as Microsoft cfM values for the lowest displayed activity
Excel, in steps 4 and 5 will simplify measurements (M). In order to test for this,
3. See “Quality Control Testing of Dose Calibra-
calculations. prepare another linearity test sample with tors,” R.Y.L. Chu and W. E. Simon, Journal of Nu-
4 Convert the time and date information an activity of about 1 mCi. Repeat the lin- clear Medicine Technology, 24, #2, June 1996, pp
you recorded to hours (t) elapsed since earity test. If the cfM values are within an 124-128.
Date Time Activity Measured, M Hours elapsed, t M0,t cfM = Avg / M0,t
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______
Avg: ______
Geometry
Geometry Independence means that the tions. The following test assumes your syringes and vials are tested through-
indicated activity does not change with injections are done with 3 ml plastic out the range of volumes commonly used.
volume or configuration of the source syringes and that radio pharmaceutical kits If a significant volume correction results
material. This test should be done using a are made in 30 ml glass vials. If you do not from these procedures, the tests should be
syringe that is normally used for injec- use these, change the procedure so that
July 8, 2004 P/N 107012 Rev. B; © 2004, Sun Nuclear Corp. page 2 of 4
repeated to verify. AtomLab dose calibra- 6 Repeat step 5 twice more until you have a syringe and inject it into the vial. Assay
tors have been tested for volume assayed 1.5 ml and 2.0 ml volumes and the vial. Record the volume and activity
dependence in beta measurements which recorded them. indicated.
are expected to be worst case and the 7 Assay the vial used to draw saline into 2 Remove the vial from the calibrator and,
results were 0.13 %/ml. 4 the syringe. If the measured activity is using a clean syringe, inject 2.0 or 3.0 ml
greater than 1% of the 0.5 ml syringe of non-radioactive saline, and assay
Syringe test
assay, Tc99m was lost during filling. again. Record the volume and activity
1 In a small vial, mix 2.0 ml of a solution of Repeat the procedure. indicated on the form (Figure 2). Repeat
Tc-99m with an activity concentration the process until you have assayed a
8 Divide the average activity by the activ-
between 1 and 10 mCi/ml. 19.0 ml volume. The entire process
ity indicated for each volume. The
2 Set out a second small vial containing quotient is a volume correction factor. must be completed within ten (10) min-
non-radioactive saline solution. utes, or, if not, decay-correct the
9 If any correction factors are greater than
3 Draw 0.5 ml of the Tc-99m solution into activity.
1.05 or less than 0.95, it will be neces-
the syringe and assay it. sary to make a correction table that will 3 Divide the average activity by the activ-
4 Record the volume and activity of the allow you to convert from “indicated ity indicated for each volume. The
first assayed sample (Figure 2). activity” to “true activity.” If this is nec- quotient is a volume correction factor.
5 Remove the syringe from the calibrator, essary, be sure to label the table 4 If any correction factors are greater than
draw an additional 0.5 ml of non-radio- “syringe geometry dependence”, and 1.05 or less than 0.95, it will be neces-
active saline into the same syringe (total note the date of the test as well as the sary to make a correction table that will
volume 1.0 ml), and assay again. Record model number and serial number of the allow you to convert from “indicated
the volume and measured activity on dose calibrator. activity” to “true activity.” If this is nec-
the form. essary, be sure to label the table “vial
Vial test (30 ml) geometry dependence”, and note the
4. See “Accurate Dose Calibrator Activity Mea- 1 To test the geometry dependence for a date of the test and the model number
surement of Y-90 Ibritumomab Tiuxetan,” J. A. Sie- 30 ml glass vial, draw 1.0 ml of Tc-99m and serial number of the calibrator.
gel et al, J Nucl Med, 2004, 45:450-454. solution (between 1 and 10 mCi/ml) into
Accuracy
Accuracy means a determination of the pal photon energy between 100 keV and calibration, serial number, model num-
dose calibrator’s absolute error resulting 500 keV. ber, and manufacturer.)
from a measurement of a suitable NIST- 1 Press the Background (Bkgnd) button 3 Repeat the procedure for the other cali-
traceable radionuclide activity. Traceable which zeroes the dose calibrator. brated reference source.
sources are available from NIST and from 2 Assay a calibrated reference source at 4 For both sources, decay-correct the ref-
many radioisotope suppliers. At least two the appropriate setting (i.e., use the Co- erence source activity value and record
sources with different principal photon 57 setting to assay Co-57). Record the as “true activity.”
energies (such as Co-57, Co-60 or Cs-137) displayed activity measurement, M, the
should be used. One should have a princi- 5 Calculate activity measurement % error
date, and the reference source identifi- from:
cation (nuclide, activity, date of
July 8, 2004 P/N 107012 Rev. B; © 2004, Sun Nuclear Corp. page 3 of 4
NOTE: Prior to making activity measurements after a preset Dial Value has been
changed on ANY isotope selection key, all Atomlab model Dose Calibrators must
be power cycled; i.e., the Dose Calibrator power switch must be turned OFF and
then back ON. Failure to power cycle after changing any preset key may cause a
measurement ERROR on any or all isotope keys.
The date on the Report of Calibration does not expire since the report is not
useful, in the typical sense, as a record of calibration in a periodic maintenance
schedule.
For example, when a survey meter is purchased, it normally comes with a calibra-
tion certificate, dated within the past 6 or 12 months. This meter is then placed on
a re-calibration schedule, as determined by local regulations. The re-calibration
date may be scheduled from the original calibration date, or simply placed on the
institution’s normal schedule interval for such meters.Re-calibration requires the
meter be shipped to a laboratory that is licensed to perform such a task. There is
no need to check the accuracy of the survey meter upon installation at the facility;
the facility generally has no means to check the accuracy of a survey meter.
The situation and requirement is different for Dose Calibrators. Although modern
manufacturing capabilities have improved the robust nature of dose calibrator
systems, these products tend to be more fragile than survey meters. Therefore,
the NRC determined at an early date that the dose calibrator accuracy must be
tested on site, prior to its introduction into clinical use. This was prudent since, a)
the dose calibrator was being used to measure radionuclides prior to administra-
tion to a patient and, b) the availability of sealed long lived isotopes made this
accuracy test very reasonable at a clinical facility.
The NRC now requires the facility using a dose calibrator to implement the
Manufacturer’s Instructions for Quality Assurance Testing of Dose Calibrators.
Such Instructions accompany all Atomlab Dose Calibrators, and requires the
Accuracy test "at installation and at least annually thereafter. After repair of the
dose calibrator, repeat the above tests as a new installation."
Therefore, the date on the Report of Calibration cannot be used as a substitute for
the installation accuracy test. The only significance of the date is when the dose
calibrator was calibrated at the manufacturer. It never receives another calibration
unless it is returned to the manufacturer. The accuracy test at the facility is not a
calibration; it is simply an accuracy test stating that the dose calibrator measures a
specific radionuclide within a stated error. The date on the Report of Calibration
does not expire until the dose calibrator is returned to the manufacturer.