Integra LifeSciences Sterilization Containers, Miltex - Manual

Integra
®
Containers
Directions for Use/English
Indications for Use
Intended for use in hospitals and healthcare facilities to contain other
medical devices that are to be sterilized and to allow sterilization of the
enclosed medical devices using steam sterilizers. Sterilized devices may be
stored and transferred in the container.
Contraindications: None known.
Precautions
Filters and filter retainers must show no visual deformations.
These parts must be checked visually and for their functionality
before usage.
Leave one inch of free space between the instruments and the
inside of the container lid for effective processing.
Do not cover filter perforated section with paper wrapped
instruments or any other objects that could obstruct the airway
and steam flow. This obstruction may cause permanent damage
to the container.
In order to avoid post-sterilization moisture caused by rapid
cooling syndrome, cool drafts from air ducts or other air currents
should be avoided. Do not place the container on cold surfaces
or expose to a cold draft. To safeguard against accidents (burns,
dropping, etc.), containers that are still hot should never be
handled with bare hands. Containers need to remain on the
container cart, in draft free area until cool enough to handle.
Pre-Cleaning
Remove lid and basket with instruments from the container. Separate the
safety lid from the container lid, if using safety lid. Remove filter retainer
plate(s). If bottom perforated, also remove retainer plates. Remove
indicators and disposable security seals and disposable paper filter.
Cleaning and Disinfection
Users must specify by means of disinfection and cleaning plan, when and
how the sterilization containers have to be cleaned and/or disinfected.
Containers that are used for waste disposal have to be cleaned and
disinfected each time after use. Do not use metal brushes or any abrasive
cleaning material. Never use bleach or other corrosive chemicals to clean
Integra containers. Abrasive products may cause chemical and physical
corrosions that will void all manufacturer warranties. For more information
concerning the inspection and cleaning of closed sterilization containers,
please see Sections 5.2.3 and 7.5.9 of ANSI/AAMI ST79 Standard.
Manual Cleaning
Use a soft sponge and neutral detergent (pH 7 phosphate-free).
Use demineralized warm water.
Rinse all the parts without leaving any stain or residue on them.
Thoroughly dry and store in clean and dry environment.
Mechanical Cleaning
Mechanical cleaning of the containers is preferred to manual cleaning.
Cleaning the containers with machines is only recommended if the washing
machine has a special washing program for aluminum containers. Place the
container bottom face down in the washing machine. (Washing Machine
has to be designed for cleaning sterilization containers. This applies in
particular to ensure secure replacement in the washing baskets and the
arrangement of the spray jets or arms.) Do not use any cleaning solutions
that contain soda or caustic acid. Do not use additional acidic neutralizers.
Use neutral detergent (pH 7 phosphate-free). Use demineralized water for
final rinsing as salt in the water may cause spotting during subsequent
sterilizations. Lids and baskets have to be removed and washed individually.
Thoroughly dry and store in clean and dry environment.
Assembly For Use
Pre-Assembly Inspection and Preparation: Select surgical instrument set
for sterilization.
Be sure all the components are completely dry. Select appropriate size
baskets and containers.
Integra containers must be checked visually before each usage. Container
bottoms, container lids and the surfaces where the seals sit must be free of
dents, visible deformations, and anything else that might appear out of the
ordinary. Do not use any spray oil or solvents on the lid seals. The seal in the
inner lid must be completely inserted and undamaged. If there is any kind
of damage, detected lids should not be used.
Note: Integra containers are designed to be used with single-use paper
filters validated for use with the containers (Integra item number
775-250). The filters are 190mm (7.5 inches) in diameter.
Filter Assembly: Place one sheet of filter paper over each perforated section
on the inside of Integra containers. Make sure it covers all the perforation
holes properly.
Make sure that filters and filter retainers are placed properly. ‘Click’ sound
should be heard while placing filter retainers by pressing on them which
indicates locking is realized. For perforated bottoms; place one filter over
the perforated section in the bottom of the container. Make sure you
hear the click sound while pressing onto the protruding pin. There is no
perforated section for the solid bottom model and it does not require a
filter or retention plate.
Caution: Filters and filter retainers must show no visual deformations.
These parts must be checked visually and for their functionality
before usage.
Instrument and Container Assembly
Place thoroughly cleaned and dried instruments into the instrument
basket(s) according to established medical facility procedures. Complex
instruments have to be prepared and sterilized according to the instrument
manufacturer’s instructions. Small baskets, trays and other types of
accessories, especially with covers and lids, should only be used with
the sterilization container which has been specifically designed for
that purpose.
The wide body containers are validated for sterilization of instruments
with lumens with a minimum diameter of 1mm and a maximum length of
300mm. Place instrument basket(s) into the prepared container bottom.
Place assembled lid onto the container bottom, aligning handles on bottom
with latches on lid. Simultaneously close both locking latches on the lid.
Caution: Leave one inch of free space between the instruments and the
inside of the container lid for effective processing.
Note: Integra container systems are not validated for use with air-driven
instruments or power systems.
Processing Assembly
Select the appropriate indicator card and insert into the holding brackets
on the outside of the container. Insert the security seals (775-400).
Secure and Lock.
Note: 1) Integra containers are protected by disposable plastic security
seals which, once attached, can be opened only by breaking which prevents
inadvertent opening of the containers, and ensures that it is evident
whether or not the sterility of the contents has been compromised. 2) Use
of internal and external indicators should be in accordance with in-house
protocol that is determined by the user.
Loading the Sterilizer: Integra containers should be placed horizontally in
the sterilizer for effective sterilization and drying.
Stacking: No stacking is allowed during sterilization.
Caution: Do not cover filter perforated section with paper wrapped
instruments or any other objects that could obstruct the airway and steam
flow. This obstruction may cause permanent damage to the container.