biodex ATOMLAB 500, Operation And Service Manual, Page: 200 / 212

Appendix J: Quality Assurance Testing of
Atomlab Calibrators (Manufacturer’s *
Instructions)
Introduction
The following procedures are the manufacturer’s instructions for qualifying Atomlab 500 and
Atomlab 500Plus Dose Calibrators in accordance with NRC regulation 10 CFR 35.60 of 1
January, 2016 (or applicable agreement State Regulation). Use of these instructions outside of
the United States 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 the first receipt of isotope activity in a container other than a plastic
syringe (± 10% from decay corrected calibration activity).
Linearity: At installation time and at least quarterly thereafter (± 5 percent).
Geometry: At installation time (± 5 percent).
Accuracy: At installation time and at least annually thereafter (± 5 percent).
After repair of the dose calibrator, repeat the above tests as if it were a new installation.
Notes:
1. A plastic well liner and source dipper must be used in all measurements.
2. If possible, leave the dose calibrator powered-on 24 hours a day, 7 days a week. If this is
not possible, allow one hour for warm up after the power is turned on and before
performing these procedures.
3. There is an acceptance variance percentage listed for each test. They are the default
settings. A value of ± 10% can be used for acceptability and a value of ± 5% can be used for
investigation. Call the Biodex Service Department if the readings are outside the acceptable
range. The default acceptable range is based on 10CFR35.60 of January 1, 2016 and IEC-
61145. It is up to the user to determine what the state or government regulations require.
4. Assay means to place the source container into the dose calibrator ensuring that the dipper
is resting in the well liner.
5. The Atomlab 500™ control module has built-in Constancy, Linearity, Geometry, and
Accuracy software functions that provide ease-of-use in performing the following functions.