Testing And Operting Requirements; Operating Temperature/Humidity/Altitude; Section Iii: Quality Control - MES SQA-iO Service Manual

Service Manual Version 187.5.1
Testing and
Manufacturer's Recommendations
Operating
Requirements
Ambient
Operating Temperature, Humidity and Altitude
Condition
Restrictions for
Operation
IMPORTANT NOTES:
Quality

SECTION III: Quality Control

Controls
Overview Internal Controls:
prior to testing.
operating system.
PASS/FAIL QC
Results
Controls Run at
Start-up
AUGUST 3, 2021
• 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:
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
o
materials test and handle semen samples.
• Maximum operational humidity is up to 80% for temperatures of up to 31
decreasing linearly to 50% humidity at 38
• Operates in a wide range of ambient temperatures (15-38
calibrated to
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.
• 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.
A series of tests are automatically run when the SQA-iO is turned on and
These internal QC tests check the calibration settings and the internal
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:
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.
SQA-iO Service Manual
º C.
measure semen samples
System stability and reference parameters are
6
º C with
º C) however the system is
at room temperature: