Case Medical SteriTite Instrucciones De Uso página 4

DEVICE DESCRIPTION: The SteriTite® Container is a rigid, reusable, sealed medical sterilization packaging
system that is compatible with all current sterilization modalities. Whenever a new packaging method is
introduced into a health care facility, all procedures associated with its use should be carefully evaluated
and adapted. For this reason, Case Medical Inc. recommends that each user of our products become familiar
with the information contained in "Comprehensive guide to steam sterilization and sterility assurance in
Health Care Facilities" and "Containment devices for reusable medical device sterilization".
1
References:
ISO/TC 198 Sterilization of Health Care Products
ANSI/AAMI ST79:2017
1
ANSI/AAMI ST77:2013
2
AAMI STANDARDS ORDER CODE: www.aami.org/publications/standards/index.html
INTENDED USE: The SteriTite® Container system is intended to be used for the sterilization of reusable
surgical instruments and medical devices in health care facilities. The contents must be placed within an
instrument basket or tray. The load may be distributed in layers using MediTray® baskets or trays.
MediTray® products may be containerized or wrapped with an FDA cleared medical wrap. Please refer to
the recommendations of your sterilizer manufacturer for specific processing instructions as well as
recommendations from your medical device manufacturer for material compatibility.
The SteriTite® sealed Container and MediTray® products are a universal, reusable packaging system with
FDA 510k and CE mark for sterilization, transport and storage of medical devices including flexible
endoscopes according to manufacturer's instructions. The SteriTite® system has been validated for use in
all current sterilization modalities, including prevacuum and gravity displacement steam, EtO, H2O2
sterilization including STERRAD 100, 100S, 200, NX, 100NX, Steris V-Pro 1, V-Pro 1 Plus, V-Pro maX, TS03
STERIZONE® VP4, and sealed immediate use steam sterilization.
The SteriTite® rigid Container system is available for both prevacuum and gravity displacement sterilizers.
The perforated bottom Containers can be used in both prevacuum and gravity displacement sterilizers, as
well as, STERRAD, Steris V-Pro sterilization and Sterizone sterilization. Solid bottom Containers can be used
in pre-vacuum steam sterilization and TSO3 cycles only. The perforated bottom Containers are ideal for
standardization as they are validated for all current sterilization methods. MediTray® baskets, trays and
accessories are intended to organize, protect and secure devices during sterilization, transport and storage.
Case Medical has validated its MediTray® products to be compatible with all sterilization modalities.
Stacking: External stacking of SteriTite® Containers is dependent on sterilization method. Refer to the
section associated with the sterilization modality in the IFU. Up to 7 trays may be stacked internally in steam
sterilization, up to 4 levels in all other modalities. Containers may be stacked for storage and transport.
Sterility Maintenance: SteriTite® Containers are event related and proven to maintain sterility during
rotation, transport and multiple handling events. According to ANSI/AAMI ST79:2017 Section 11.1, "the
shelf life of facility-sterilized items is event-related and should be based on the quality of the packaging
material, the storage conditions, the methods and conditions of transport, and the amount and conditions
of handling". SteriTite® Containers have also been validated for one-year shelf life.
CONTRAINDICATIONS – not known
VALIDATION TESTING: Case Medical subscribes to the overkill principle. SteriTite® and MediTray®
products are validated in independent laboratories under fractional and half cycle conditions. Health care
personal need to perform testing to verify the effectiveness of the Container system in the hospital's
sterilizer. Place biological indicators/integrators in opposing corners of each tray/basket within the
Container for verification. Validation testing was performed per ANSI/AAMI ST77, ST79, TIR12, and EC
Directive 93/42/EEC (Medical Devices Directive), CE Directions DIN 58952 and EN UNI 868 part 8.
Copyright 2020 Case Medical, Inc.®
SteriTite®, the Container system of choice
4
2
IFU-CASETRANS Rev. 004A
E
n
g
l
i
s
h