Capintec CAPTUS 4000e - CHAPTER 2 FUNCTIONAL & TECHNICAL DESCRIPTION; INTENDED USE; OPERATOR PROFILE; OPERATOR TRAINING

CAPINTEC, INC. CAPTUS
®
4000e
July 16 FUNCTIONAL & TECHNICAL DESCRIPTION 2-1
CHAPTER 2
FUNCTIONAL & TECHNICAL
DESCRIPTION
INTENDED USE .............................................................................................. 2-1
OPERATOR PROFILE .................................................................................... 2-2
OPERATOR TRAINING .................................................................................. 2-2
FUNCTIONAL DESCRIPTION ........................................................................ 2-2
Thyroid Uptake ........................................................................................... 2-2
Wipe Test .................................................................................................... 2-3
Lab Tests .................................................................................................... 2-3
Bioassay ..................................................................................................... 2-4
TECHNICAL DESCRIPTION ........................................................................... 2-4
Detector ...................................................................................................... 2-4
Multi-Channel Analyzer .............................................................................. 2-5
TECHNICAL SPECIFICATIONS ..................................................................... 2-6
System Hardware ....................................................................................... 2-6
Environment Requirements ....................................................................... 2-8
Warm Up Period ......................................................................................... 2-9
System Power Requirements .................................................................... 2-9
Regulatory Listings ................................................................................... 2-10
INTENDED USE
The CAPTUS
®
4000e Thyroid Uptake / Well System is intended to be used by trained
Nuclear Medicine Technologists for performing Thyroid Uptake, Thyroid Bioassay, Wipe
Test, Blood Volume (with Cr-51 or I-125) Test, Schillings Test and RBC Survival Test.
Also using the system are Health Physicists with expertise in nuclear medicine and radiation
safety – typically used for assessing reproducibility of counting instruments with various
Quality Assurance procedures (Chi-Square, Linearity, Constancy, Accuracy, etc.).
The CAPTUS
®
4000e also performs Pulse Height Analysis, isotope identification,
radioisotope decay corrections, efficiency calculations and maintains a database for storage
and easy retrieval of patient demographic data and measurement results.