Service Manual Version 18
7
.5.1
AUGUST 3, 2021 SQA-iO Service Manual
6
Testing and
Operating
Requirements
Ambient
Condition
Restrictions for
Operation
Quality
Controls
Overview
PASS/FAIL QC
Results
Controls Run at
Start-up
Manufacturer
’s
Recommendations
•
The SQA-iO is sensitive to vibrations during the testing cycle. Operate away from
devices that cause electronic noise or vibrations such as centrifuges.
•
Un-plug the device when not in use for an extended period of time.
•
Ambient temperature limitations: The SQA-iO is calibrated to conduct tests at room
temperature: 20-25ºC (68-77ºF). This is the recommended range for room
temperature maintenance of semen samples prior to testing for up to 1 hour following
collection.
•
Sample processing limitations:
The device is calibrated to test semen samples at
room temperature. Heating samples in ANY WAY will impact results. Do not heat
samples.
•
Semen is considered biologically hazardous material and is subject to
individual laboratory protocols for handling such materials. At a minimum,
it is recommended to:
o
Wear laboratory coat, mask and gloves when handling semen
o
Dispose of samples post testing in designated hazardous waste containers
o
Require that only personnel trained to work with biologically hazardous
materials test and handle semen samples.
Operating Temperature, Humidity and Altitude
•
Maximum operational humidity is up to 80% for temperatures of up to 31
º
C with
decreasing linearly to 50% humidity at 38
º
C.
•
Operates in a wide range of ambient temperatures (15-38
º
C) however the system is
calibrated
to
measure
semen
samples
at
room
temperature:
20-25
º
C (68-77
º
F).
•
Intended for indoor use at a maximum altitude of 2000m, mains supply fluctuations
±10%, Overvoltage Category II, Pollution Degree II.
IMPORTANT NOTES:
•
Humidiy exceeing the limitations above may impact test results due to condensation
on the optical detectors. Assess ambient humidity and temperature prior to device
operation.
•
Ambient temperatures exceeding the limitation above may impact the accuracy of
semen motility test results because of the known effect of temperature on human
semen.
SECTION III: Quality Control
Internal Controls:
A series of tests are automatically run when the SQA-iO is turned on and
prior to testing. These internal QC tests check the calibration settings and the internal
operating system.
Internal Controls are run @ SQA-iO Start-up: PASS/FAIL results are reported
on the SQA-iO home screen along with troubleshooting information
•
Stabilization and autocalibration:
System stability and reference parameters are
checked to ensure they are in proper range by analyzing the system sensors. Once
stable for 30 seconds the device passes stabilization and autocalibration. A warning
message is displayed on the home screen if there is a failure.
•
System noise:
Measures the electronic noise level of the system to insure effective
measurement of electronic signals.
•
Self-test:
Electronic signals simulating motility and concentration measurements
verify that the calibration settings are consistent with factory specifications.
