Section 6: Controls And Qc; Set-Up: Assayed Control - MES SQA-V Gold User Manual

User Guide Version 2.60 I-Button
Controls
SECTION 6: Controls
Set-Up and
Testing
External quality control samples (CONTROLS) are run on the RUN CONTROLS mode
from the MAIN MENU of the SQA-V. Commercially available latex beads or stabilized
Please note:
sperm CAP can be run as non-assayed controls. QwikCheck™ beads produced by
Medical Electronic Systems are assayed for the SQA-V. It is recommended that
When a new control lot
controls be run daily or based upon laboratory protocols.
is used, the control
default settings must
The control media is aspirated into the testing capillary and run in the same manner
be changed prior to
as a normal volume specimen in the testing compartment of the SQA-V.
initiating a test.
Refer to section(s):
For each new lot of controls, SQA-V system defaults need to be set-up/updated
through V-Sperm GOLD prior to running a test. To run an assayed control use the
Set-up: Assayed
information for Target Value and +/- Range provided on the product labeling. To run a
Control and
non-assayed control, the Target Value and +/- range must be established by the
Set-up: Non Assayed
laboratory or set 0 (zero) if not established. Follow instructions below to set-up an
material
assayed or non-assayed material. The testing process is the same.

Set-Up: Assayed Control

Each time a new lot of an assayed control is to be run, the user must set-up/update
the CONTROL settings through V-Sperm GOLD as described below. Previous settings
(defaults) will remain in place until updated.
Please note:
Level 1, 2, and
NEGATIVE control set-
up screen from
V-Sperm GOLD.
The NEGATIVE control
may also be labeled
Level 3 control on the
SQA-V.
For the SQA-V to work
properly the CONTROLS
must have set-up data
inserted. If control
material is not available
or non-assayed enter
current date in the EXP
Date field and zeros in
all other fields.
Revision 21_Sep_2015
Step 1: From the SQA-V MAIN MENU select SERVICE > SERVICE DATA.
Step 2: Make sure the SQA-V is connected to the PC via the RS232
communication cable.
Step 3: Activate the V-Sperm on the PC and select: SET-UP > SQA-V and
press CONTINUE.
Step 4: The set-up screen below will be activated in V-Sperm GOLD on the PC:
Step 5: Select the type of control (Latex Beads or Stabilized Sperm)
Step 6: Enter the following information from the box labeling:
LOT# - number identifying the control media lot.

EXP. DATE

TARGET VALUE and +/- Range

and +/- Range" for the SQA-V Automated System.
NEGATIVE

Step 7: To save settings: Press APPLY. The set-up may take two minutes.
– control expiration date (MM = month, YY = year).
–manufacturer's "Target Value
control target values and +/- ranges are pre-set to 0.0.
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