Directions For Use - 3M Attest 1295 Manual Del Usuario

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.
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.
• DO NOT reincubate 1295 BIs for which the
Auto-Reader has already determined a result.
3. To ensure the product functions as intended
throughout the labeled shelf life, store 1295 BIs in
the resealable foil pouch until use.
4. Incubation beyond the final fluorescent readout is
not required. If, however, special studies are
desired, 1295 BIs may be further incubated for a
visual pH color change result. To avoid media dryout,
it is recommended that the 1295 BI be transferred to
a humidified incubator operating at 60ºC after the
fluorescent result has been recorded.
Monitoring Frequency
Follow facility Policies and Procedures which should
specify a biological indicator monitoring frequency
compliant with professional association recommended
practices and/or national guidelines and standards. As a
best practice and to provide optimal patient safety, 3M
recommends that every sterilization load be monitored
with a biological indicator.

Directions for Use

1. Remove 1295 BI from sealed foil pouch, then reseal
foil pouch if other 1295 BIs remain in foil pouch. Do
not place any labels or indicator tape on the vial or
on the cap.
2. Place the 1295 BI in a sterilization pouch indicated
for use in vaporized hydrogen peroxide sterilization
processes. Seal the sterilization pouch.
3. Place the pouched BI in the sterilizer chamber, with
the white side of the pouch facing up and the clear
plastic side facing down. When there is adequate
space in the loaded sterilizer chamber, place the
pouched BI directly on the sterilizer chamber rack
or shelf. The sterilizer manufacturer should be
consulted to identify the area of the chamber to
place the BI.
4. Process the load according to recommended
practices.
5. After completion of the cycle, don safety glasses
and gloves and remove the pouched BI from the
sterilizer. Inspect the 1295 BI to verify the media
ampoule is intact. If a chemical indicator was
included in the pouch with 1295 BI, inspect the
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