Integra LifeSciences Pessary Fitting Set - Manual

Integra
®
Miltex
®
Pessary Fitting Set
Directions for Use/English
Description
The Pessary Fitting Set is to help determine the proper style and size of pessary for each patient. It includes six
popular Ring pessaries and an embossed cross-reference chart to use in selecting the appropriate pessary.
The Pessary Fitting Set is supplied non-sterile.
Cleaning Instructions/Sterilization Instructions
1. Cleaning: submerge in enzymatic cleaner for 20 minutes. Remove from enzymatic cleaner and rinse
thoroughly with demineralized water. Allow to dry completely prior to sterilization.
2. Disinfecting: use disinfecting solution for 12 minutes. Be sure to review and follow manufacturer of the
disinfecting solution’s instructions of use. Remove from disinfecting solution and rinse thoroughly with
demineralized water. Allow to dry completely prior to sterilization.
3. Recommended Sterilization Parameters:
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0434
EC REP
Sterilizer Exposure Temperature Exposure Time Minimum Dry Time
Pre-Vacuum
(Wrapped) 132°C (270°F) 4 minutes 20 minutes
Pre-Vacuum
(Un-wrapped) 132°C (270°F) 4 minutes -
Gravity Steam 121°C (250°F) 30 minutes 30 minutes
Gravity Steam 132°C ~ 135°C
(270°F ~ 275°F) 10 minutes 30 minutes
Pessary
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 product defect. Determination of a product
defect will be made by Integra. Products will not be accepted for replacement if they have been in the
possession of the customer for more than 90 days.
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, the Integra logo, and Miltex 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. SURG-IFU-PESSET Rev. C 10/13
1 Company responsible for a device marketed under its own name regardless of whether
“manufactured for” or “manufactured by” the company.
Manufacturer 1
Catalog number
Lot number
Caution! See Warnings
and Precautions
Consult instructions for use
Federal (USA) law restricts this
device to sale by or on the order
of a physician or practitioner EC REP European Authorized
Representative
0123
0434
Product complies with
requirements of directive
93/42/EEC for medical devices
Not made with
natural rubber latex
Symbols
Symbols may be used on some package labeling for easy identification.
EU Representative
Wellkang Ltd
i Suite B, 29 Harley Street i LONDON, W1G 9QR, U.K.
Manufactured for
Integra York PA, Inc.
i 589 Davies Drive, York, PA 17402
866-854-8300 USA i +1 717-840-2763 outside USA i +1 717-840-9347 fax
integralife.com/integra-miltex
EC REP
Manufacturer
Panpac Medical Corporation
i 6F-2, No. 202, Sec. 3, Ta-Tong Rd.,
Shi-Chih Dist., New Taipei City i TAIWAN, R.O.C. i Phone: (886)-2-8647-2242
Fax: (886)-2-8647-2770