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
Note: If RRBIs are inadvertently removed before the incubation period is complete, an alarm will sound and all three lights (+, •, and
WARNING
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.
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
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.
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