MES SQA-V Gold, Руководство пользователя

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User Guide Version 2.60 I-Button
Revision 21_Sep_2015 21
Controls
Set-Up and
Testing
Please note:
When a new control lot
is used, the control
default settings must
be changed prior to
initiating a test.
Refer to section(s):
Set-up: Assayed
Control and
Set-up: Non Assayed
material
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.
SECTION 6: Controls
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
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
controls be run daily or based upon laboratory protocols.
The control media is aspirated into the testing capillary and run in the same manner
as a normal volume specimen in the testing compartment of the SQA-V.
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
information for Target Value and +/- Range provided on the product labeling. To run a
non-assayed control, the Target Value and +/- range must be established by the
laboratory or set 0 (zero) if not established. Follow instructions below to set-up an
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.
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 – control expiration date (MM = month, YY = year).

TARGET VALUE and +/- Range –manufacturer's "Target Value
and +/- Range” for the SQA-V Automated System.

NEGATIVE control target values and +/- ranges are pre-set to 0.0.
Step 7: To save settings: Press APPLY . The set-up may take two minutes.