biodex ATOMLAB 500 - Quality Assurance Testing of Atomlab Calibrators

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Biodex Medical Systems, Inc. © 2016 235
Appendix J:
Quality Assurance Testing Of Atomlab
Calibrators (Manufacturer's* Instructions)
Introduction
The following procedures are the
manufacturer’s instructions for
qualifying Atomlab
®
100, 100+, 200,
300, 400, and 500 dose calibrators in
accordance with NRC regulation 10
CFR 35.60 of 1 January 2003 (or
applicable agreement State
Regulation). Use of these instructions
outside the USA may require
modification in order to satisfy local
regulations.
Qualification is the determination of
errors associated with the following
tests at the indicated frequency.
Acceptable errors for each test are
indicated in parentheses.
• Constancy: Starting at installation
and at least once each day before
measuring patient dosages (±5
percent).
• Dial Value Setting: at first receipt of
isotope activity in container other
than a plastic syringe (±10% from
decay corrected calibration activity).
Constancy
Constancy means reproducibility in
measuring the same source, over a
period of time, with decay correction.
Assay a relatively long-lived source
(such as Cs-137) each day before using
the calibrator.
Cs-137, 100 µCi minimum activity, is
strongly recommended because the 30-
year half life will assure use of the same
source throughout the life of the
calibrator, and it is readily available.
Consider using the following procedure
or equivalent:
1 Press the Zero Background (Bkgnd)
button. When the display zeroes,
• Linearity: at installation and at least
quarterly thereafter (±5 percent).
• Geometry: at installation (±5
percent).
• Accuracy: at installation and at least
annually thereafter (±5 percent).
After repair of the dose calibrator,
repeat the above tests as a new
installation.
NOTE: A plastic well liner and source
dipper must be used in all
measurements.
NOTE: If possible, leave the dose
calibrator powered-on 24 hours a day, 7
days a week. If not, allow 1 hour warm-
up after power-on before performing
these procedures.
the unit has automatically adjusted
for Background.
2 Assay each reference source using
the appropriate dose calibrator set-
ting (i.e., use the Cs-137 setting to
assay Cs-137.)
3 Record the activity reading of the
constancy source in a permanent
log.
4 Compare the measurement
observed to the calculated activity
of the source and if the measure-
ment exceeds 5% of predicted,
investigate potential sources of
error (patients in the area, exposed
NOTE: We have an acceptance
variance percentage listed for each
test. These are the default settings. You
can use ±10% for acceptability and ±5%
for investigation. Call Biodex Service
Dept. If readings are outside the
acceptable range. The default
acceptable range is based on
10CFR35.60 of January 1, 2003 and
IEC-61145. You must consider what
your state or government regulations
require.
NOTE: Assay means to place the
source container into the dose
calibrator so that the dipper is resting in
the well liner.
NOTE: The Atomlab® 500 control
module has built-in Constancy,
Linearity, Geometry, and Accuracy
software functions which provide ease-
of-use to the user in performing the
functions below.
sources, use of the wrong isotope or
setting, etc.)
5 If the constancy result is determined
to be greater than 10% of predicted,
suspend the use of the instrument
and repair or replace the dose
calibrator.
NOTE: It is recommended that the
Cs-137 and Ba-133 sources be
replaced when the activity is below
100 µCi. It is recommended to
replace a Co-57 source when the
activity is less than 200 µCi.
*Manufactured by Sun Nuclear Corporation, Melbourne, FL; distributed by Biodex Medical Systems.