Integra LifeSciences Uterine Sound, Disposable - Manual

Description
The Uterine Sound is used to gauge the depth and position of the uterine cavity. It
is also helpful with the placement of IUDs (Intra-uterine device) and the verification
of the intrauterine position and length for HSG (Hysterosalpingography)
procedures. The proximal portion of the sound is 3.5 mm in diameter tapering to
2.5 mm at the distal portion with a bulbous tip to reduce the risk of perforation.
The device is malleable to adapt to anatomical variations.
It is a sterile, disposable, single-use only device.
Indications
The Uterine Sound is used to gauge the depth and position of the uterine cavity. It
is also helpful with the placement of IUDs and the verification of the intrauterine
position and length for HSG procedures.
Contraindications
The Uterine Sound should not be used when the following conditions
are present:
• Infection, including but not limited to, Acute Cervicitis and Endometriosis.
• Unexplained uterine bleeding.
• A pregnancy or the suspicion of a pregnancy.
Precautions
• Check the packaging for damage which can compromise sterility.
• Visually inspect the sound for any surface damage prior to use.
• Disposable Uterine Sounds are designed for single-patient use only.
• This procedure should only be performed by a trained medical professional.
• The use of excessive force should be avoided.
• Minor bleeding, cervical inflammation, and abdominal cramps may occur.
Warnings
• Gently introduce and manipulate the tip of the sound through the
cervical canal.
• Forced entry could create a false tunnel and bleeding.
Instructions
The Uterine Sound is a single-use sound made of white, malleable, plastic material.
Prior to use, the sound can be curved between the thumb and finger in order to
follow the curve of the cervical canal. The graduations are in centimeters and allow
for the measurement of the uterine cavity.
Dispose of the Uterine Sound in accordance with all applicable Federal, State and
local medical and hazardous waste practices.
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
®
Miltex
®
Disposable Uterine Sounds
Directions for Use / English
LOT REF
REF 30-6000 Disposable Uterine Sounds, Sterile
0434
Consult Instruction for Use
CAUTION: Federal (USA) law
restricts this device to sale by or
on the order of a physician
Not made with natural
rubber latex
Product complies with
requirements of directive
93/42/EEC for medical devices
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
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
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. SURGUTERINESNDFU Rev. A 12/13
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) 28647-2770
EC REP
Symbols used on labeling
0434
2
EXP Expiration date
Single use only
STERILE EO
STERILE EO Sterilized using ethylene oxide