Integra LifeSciences Pessary Remover - Manual

Integra
®
Miltex
®
Pessary Remover
Directions for Use/English
Description
The Pessary Remover is designed to facilitate easier removal of a pessary. The pessary remover is
designed for use with the following pessary types: the ring, ring with knob, oval, dish, hodge or
marland. This device may be used with both a no support and support membrane version of the
pessary types listed previously. The Pessary Remover is supplied non-sterile.
Warnings
• Avoid the use of excessive force when inserting the pessary remover into the vagina.
• Visually inspect the device prior to use. Do not use if any visible defects are identified.
Precautions
• Use of a lubricant is recommended when using the pessary remover to remove a pessary.
• The pessary remover does not fit through the holes in the pessaries.
• The Pessary Remover is a tool used to facilitate the removal of a pessary and provides no
specific treatment benefits.
Instructions
1. Lubricate the introitus, and secure the remover to the inside center of the pessary.
2. Apply gentle traction on the pessary cord to stabilize and bring the device toward the introitus.
3. When the pessary is within reach, compress the pessary and carefully pull it gently out of
the vagina.
Cleaning Instructions/Sterilization Instructions
Cleaning
1. Submerge in enzymatic cleaner for 20 minutes.
2. Remove from enzymatic cleaner and rinse thoroughly with demineralized water.
3. Allow to dry completely prior to sterilization.
0123
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)
132°C ~ 135°C (270°F ~ 275°F) 30 minutes
10 minutes 30 minutes
30 minutes
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.©2014 Integra LifeSciences Corporation. All Rights Reserved. SURGPESRMVDFU Rev. AA 12/13
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
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
30-900 Stainless Steel Pessary Remover
Recommended Sterilization Parameters:
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