3M VH202 Manual De Instrucciones página 4

Due to the high reliability of the fluorescent result
there is no advantage to incubating 1295 BIs after the
fluorescent result has been determined by the 490H
Auto‑reader or 490 Auto‑reader having software
version 4.0.0 or greater and recorded.
1295 BIs meet ISO 11138‑1:2017.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological
Indicator 1295 in conjunction with the 3M™ Attest™
Auto‑reader 490H or 490 Auto‑reader having software
version 4.0.0 or greater as a standard method of routine
monitoring of vaporized hydrogen peroxide sterilization
processes in the following systems: AMSCO
1 Low Temperature Sterilization System (Lumen
cycle), AMSCO V‑PRO
®
Sterilization System (Lumen and Non Lumen cycles),
AMSCO V‑PRO maX Low Temperature Sterilization
® ®
System (Lumen, Non Lumen, and Flexible cycles),
AMSCO V‑PRO 60 Low Temperature Sterilization
® ®
System (Lumen, Non Lumen and Flexible cycles) and
in STERRAD 100S, STERRAD
®
Advanced cycles), STERRAD
Express and Duo cycles) systems, STERRAD
AllClear™ Technology (Standard and Advanced cycles)
and STERRAD 100NX with AllClear™ Technology
®
(Standard, Flex, Express and Duo cycles).
Contraindications
None.
Warnings
There is a glass ampoule inside the plastic vial of the
biological indicator (BI). To avoid the risk of serious
injury from peroxide burns:
• Wear safety glasses and gloves when removing
the 1295 BI from the sterilizer.
• Wear safety glasses and gloves when activating
the 1295 BI.
• Handle the 1295 BI by the cap when crushing
or flicking.
V‑PRO
®
1 Plus Low Temperature
®
NX (Standard and
®
100NX (Standard, Flex,
®
NX with
®
Residual hydrogen peroxide may be trapped within the
1295 BI if the media ampoule is damaged during the
sterilization process. If a broken ampoule is observed
after processing, avoid direct contact with the 1295 BI
as it may result in hydrogen peroxide burns. Follow
the disposal instructions provided at the end of
this document.
Precautions
1. Do not use the 1295 BI to monitor sterilization cycles
which it is not designed to challenge:
a. Steam sterilization cycles;
b. Dry heat sterilization cycles; or
®
c. Ethylene oxide sterilization processes.
2. To reduce the risk associated with incorrect results:
• Before sterilization, inspect 1295 BI to verify
media ampoule is intact and process indicator
stripes are blue. Do not use any 1295 BIs which
have a broken media ampoule or process
indicator stripes which are not blue.
• Do not place tape or labels on 1295 BI prior to
sterilization or incubation in the Auto‑reader.
• Activate and incubate the 1295 BI within 1 hour
after the completion of the sterilization cycle.
• Do not incubate a 1295 BI if, after processing
and before BI activation, it is observed to have a
broken media ampoule. Retest the sterilizer with
a new biological indicator.
• After 1295 BI activation, ensure media has flowed
to the spore growth chamber.
3. To ensure the product functions as intended
throughout the labeled shelf life, store 1295 BIs in
the resealable foil pouch until use.
2