Integra LifeSciences Sterilization Containers, Miltex - Manual (Page 2)

Processing
The loading instructions of the sterilizer manufacturer should be observed.
High vacuum (pre-vacuum, three pulse, standard) Temp: 132° C (270° F)
Exposure Time: 4 minutes (minimum) Cycle Dry Time: 20 Minutes (minimum)
Cool Time: Varies according to load contents.
Caution: 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.
Note: Maximum load weight of the basket and its contents should not
exceed the following chart for effective sterilization and drying:
Shelf Life
In protected storage (temperature, humidity, air filtration etc. controlled
medical facility storage room conditions) containers can store high-vacuum
(pre-vacuum) sterilized medical devices for up to 6 months, provided the
integrity of the container is not compromised. (Tamper-evident security
seal 775-400 remains intact.) Note: Integra containers can be stacked
during storage, one on top of another. Make sure that heavier container
is placed at the bottom.
Periodic Maintenance
Integra suggests periodic maintenance to ensure all parts are in good
working order.
Integra Container Systems Warranty
Integra hereby warrants all products carrying the registered trademark and
logo of Integra purchased directly from Integra or an authorized dealer
in accordance with the following terms and conditions: The warranty
period of Integra containers is two years from the date of purchase.
Integra containers are guaranteed to be free from defects in material and
workmanship when used for its intended purpose. Containers that prove
defective in material or workmanship will either be repaired or replaced free
of charge during the warranty period. Containers that are not purchased
from Integra or an authorized source may not meet Integra quality
standards.
Repair or Replacement
Under this warranty, Integra will repair or replace any parts and determine
the nature of any defect, the necessity and manner of repair or replacement,
and all other matters pertaining to the conditions of the Integra
container systems.
Exclusions
This warranty shall not apply to any condition(s) or damage resulting
from misuse, improper cleaning, improper handling, negligence, improper
opening or unauthorized repair work including but not limited to: Incidents
of abuse such as denting of Integra container due to dropping or other
instances of mechanically applied pressure. Damage determined to be
related to caustic or abrasive cleaning agents, items modified by the
customer, items modified or customized by Integra at the request of the
customer, damage from fire, flood and other occurrences not under the
control of Integra.
Returned Goods Policy
Products must be returned in unopened packages with manufacturer’s seals
intact to be accepted for replacement or credit unless returned due to a
complaint of defect.
Repairs And Maintenance
Should your containers require repair or maintenance, contact Integra
for return authorization and address. Containers returned to Integra for
repair must have a statement testifying that each container has been
thoroughly cleaned and sterilized. Failure to supply evidence of cleaning
and disinfection will result in a cleaning charge and delayed processing of
your container repair.
PRODUCT INFORMATION DISCLOSURE
INTEGRA AND ITS SUBSIDIARIES (“INTEGRA”) AND MANUFACTURER
EXCLUDE ALL WARRANTIES, EXCEPT INTEGRA’S APPLICABLE STANDARD
WARRANTY WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT
NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER INTEGRA
NOR MANUFACTURER SHALL BE LIABLE FOR ANY INCIDENTAL OR
CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY
ARISING FROM USE OF THIS PRODUCT. NEITHER INTEGRA NOR
MANUFACTURER ASSUME NOR AUTHORIZE ANY PERSON TO ASSUME
FOR THEM ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
CONNECTION WITH THESE PRODUCTS.
Integra containers with filter system
Model Perforations Dimensions Load Limit LBS
1/1 size
container
models
Perforated lid and non-
perforated bottom
580 x 280 x 100 mm 24.75
580 x 280 x 135 mm 24.75
580 x 280 x 150 mm 24.75
580 x 280 x 200 mm 24.75
600 x 400 x 120 mm 24.75
600 x 400 x 180 mm 24.75
Perforated lid and
perforated bottom
580 x 280 x 100 mm 24.75
580 x 280 x 135 mm 24.75
580 x 280 x 150 mm 24.75
580 x 280 x 200 mm 24.75
580 x 280 x 260 mm 24.75
600 x 400 x 120 mm 24.75
600 x 400 x 180 mm 24.75
Full size wire and
perforated baskets
540 x 255 x 30 mm N/A
540 x 255 x 50 mm N/A
540 x 255 x 70 mm N/A
540 x 255 x 100 mm N/A
3/4 size
container
models
Perforated lid and non-
perforated bottom
465 x 280 x 100 mm 12.5
465 x 280 x 135 mm 12.5
465 x 280 x 150 mm 12.5
Perforated lid and
perforated bottom
465 x 280 x 100 mm 12.5
465 x 280 x 135 mm 12.5
465 x 280 x 150 mm 12.5
Mid size wire and
perforated baskets
405 x 255 x 30 mm N/A
405 x 255 x 50 mm N/A
405 x 255 x 70 mm N/A
405 x 255 x 100 mm N/A
1/2 size
container
models
Perforated lid and
perforated bottom
285 x 280 x 100 mm 9.25
285 x 280 x 135 mm 9.25
285 x 280 x 150 mm 9.25
285 x 280 x 200 mm 9.25
285 x 280 x 260 mm 9.25
Perforated lid and non-
perforated bottom
285 x 280 x 100 mm 9.25
285 x 280 x 135 mm 9.25
285 x 280 x 150 mm 9.25
285 x 280 x 200 mm 9.25
Half size wire and
perforated baskets
255 x 245 x 30 mm N/A
255 x 245 x 50 mm N/A
255 x 245 x 70 mm N/A
255 x 245 x 100 mm N/A Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its
subsidiaries in the United States and/or other countries.
©2013 Integra LifeSciences Corporation. All Rights Reserved. F-13165 REV. 1 6/13
Consult Instruction for Use
CAUTION: Federal (USA) law
restricts this device to sale by or
on the order of a physician
Product complies with the
requirements of directive
93/42/EEC (Class I Devices Only)
Manufacturer 1
European Authorized
Representative
Catalog number
Lot Number
Caution! See Warnings
and Precautions
1 Company responsible for a device marketed under its own name regardless of
whether “manufactured for” or “manufactured by” the company.
EC REP
REF
LOT
EU Representative
Integra LifeSciences Services (France) SAS Immeuble Sequoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
Fax: 33 (0) 4 37 47 59 29
Manufacturer
Integra York PA, Inc.
i 589 Davies Drive, York, PA 17402
integralife.com/jarit
EC REP
Symbols used on labeling
0123