Service Manual Version 18
7
.5.1
AUGUST 3, 2021 SQA-iO Service Manual
3
SECTION I: Introduction
The SQA-iO is a high-performance PC-based analytical medical device that tests FRESH
semen samples. The device works with a computer application that contains the device,
patient, sample, test results and facility information.
After collection and preparation, a ~1 ml semen sample is withdrawn into an SQA capillary
disposable delivery system, inserted into the SQA-iO where key parameters are collected,
and sample test results are processed utilizing proprietary technology and algorithms. The
testing process takes approximately 75 seconds.
The system runs an automatic self-test and auto-calibration upon start up and checks
device stability before each sample is run.
Automated
Test Results
and
Reportable
Range
SQA-iO Reportable Range
Sample
Type
Conc.
(M/ml)
Motility
(%)
PMSC
(M/ml)
Morph Norm
Forms (%)
MSC
(M/ml)
Fresh
<2 - 400
0 - 100
0 - 400
2 - 30
<0.2 - 400