MES SQA-Vision Service Manual page 6

SQA-Vision
Service Manual Version 109.13.4

Turn the system OFF when not in use for an extended period of time.

When running Postvasectomy tests do not interrupt test cycle nor interfere with system
or testing capillary in any way – this test is highly sensitive to any motion and requires
complete stability of the system during the 5-minute testing cycle.

Variations in ambient temperature can affect semen sample parameters. It is essential
that semen samples are not heated for testing. The SQA-Vision is calibrated to conduct
tests at room temperature: 20-25ºC (68-77ºF).

Semen is considered a biologically hazardous material and is subject to
individual laboratory protocols for handling such materials and at a minimum:



Operating Temperature and Humidity

Maximum operational humidity is up to 80% for temperatures of up to 31
decreasing linearly to 50% at 38

Operates in a wide range of ambient temperatures (15-38
calibrated
20-25
motility test results because of the known effect of temperature on human semen.
Operational Environmental conditions:

System is intended for indoor use at a maximum altitude of 2000m, mains supply
fluctuations ±10%, Overvoltage Category II, Pollution Degree II.
PC / Hardware

PC and device:
Quality Control

Internal:
Besides that, reference values are verified prior to each test.

External:
latex bead control: "QwikCheck™-beads" (product of Medical Electronic Systems) for
concentration and negative control for motility/concentration OR non-assayed: Latex
beads or stabilized sperm CAP or NEQAS for concentration.
Sample Testing

Sample Testing Temperature:
will be impacted by heating the specimen (not recommended).

System calibrated to test Human semen and specified Control samples only.
for use with animal semen.

SQA-Vision measurement capillary:
500 µl of sample for normal volume testing, 20 µl for low volume testing, 300 µl for diluted
mode. Use only manufacturers' certified testing capillaries in the automated system.

Field of View Stage:
compartment. Vision™ fixed cover slip slides (obligatory for accurate test results when
manual sperm counting is required), standard slides (for debris scans and image
capturing) are accepted in the field of view stage using the supplied slide holder.
Edition rev.: Jan 2020
Laboratory coat, mask and gloves for operating personnel protection
Samples handling and waste disposal in specially marked hazardous waste containers
Only personnel trained to work with biologically hazardous materials such as semen
should be testing and handling semen
to measure
º º
C (68-77 F). Note: Extreme ambient temperature may impact the accuracy of
"All in One" - computer with SQA-Vision software and device.
Electronic Self-Test and Auto-Calibration. Runs automatically upon start-up.
Runs QC samples daily prior to testing or per laboratory protocol. Runs assayed
This stage is an integral part of the SQA-Vision visualization
º
C.
semen samples
Calibrated for room temperature only. Motility results
Disposable, plastic, testing capillary. Requires
6
º
C with
º
C) however the system is
at room temperature:
Not