3M Attest 290, Руководство оператора

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3M © 2003 78-8078-8977-5 Page 5 of 9 Attest 290 Auto-reader
INSTRUCTIONS FOR USE
Wells are color coded to match the cap of
each type of biological indicator
; i.e. the 1291
RRBI with a blue cap goes into a blue well and the
1292 RRBI with a brown cap goes into a brown
well.
A yellow light will come on to indicate the RRBI is
incubating in the reader well and should
not be
touched. A yellow light indicates the results are not
available and incubation is in progress.
Do not remove RRBIs until the red (+) or green
(-) light indicates the test is complete.
Note: If RRBIs are inadvertently removed before
the incubation period is complete, an alarm will
sound and all three lights (+, •, and -), for that
incubation well will light. C2 Caution code will also
be displayed. You
must return the RRBI to the
reader well within 10 seconds or the results will
be lost.
All red, yellow and green lights will flash for one
second when the cover is opened demonstrating
they are functional.
The cover should
only be opened when placing
additional RRBIs into incubation wells or when
removing RRBIs at the completion of the
designated incubation period.
A positive result (+) will automatically be shown as
soon as it is detected. The full incubation period is
required before a negative result (-) is shown. The
Attest 1291 RRBI requires 1 hour of incubation and
the Attest 1292 RRBI requires 3 hours of incubation
before a negative (-) result will be shown. The
negative result will be shown automatically after
completion of the required incubation time.
The processed indicator and the positive control
may also be further incubated for a visual pH color
change. The final negative reading (media remains
purple) for a visual color change is made at 24 hours
(1291) or 48 hours (1292). The positive control
should show a yellow color change of the growth
media. For any incubation beyond 24 hours (1291)
or 48 hours (1292), RRBIs should be moved to a
humidified environment.
Each facility must establish final readout time in its
policy and procedures. The policy should be based
on manufacturer’s instructions for use, scientific
knowledge, current recommendation practices,
applicable compliance requirements, inventory
levels, and the risk to the patient if the medical
device is not sterile.
W
W W
WARNING
ARNING ARNING
ARNING
Do not remove or change placement
of RRBI once it is placed into a well.
Doing so may result in loss of results
and the RRBI test may be invalid.