Integra LifeSciences Cervical Dilators, Disposable - Manual

REF 30-5001 Disposable Os Locator, Sterile
REF 30-5002 Disposable Canal Dilator, Sterile
REF 30-5003 Disposable Fundus Sound. Sterile
Description
The Os Locator
One molded band above the tactile handle and opposite the distal end of the
device identifies the disposable Os Locator. The Os Locator may be used to find and
gently dilate the external os.
The Canal Dilator
Two molded bands above the tactile handle identify the Canal Dilator from the Os
Locator and the Fundus Sound. The Canal Dilator may be used to slowly dilate the
length of the cervical canal.
The Fundus Sound
Three molded bands opposite the distal tip identify the Fundus Sound from the Os
Locator and the Canal Dilator. The Fundus Sound is designed to pass through the
entire length of the cervix, dilate the internal os and sound the fundus to determine
uterine depth.
Indications
Cervical dilators are used in locating and dilating the external os, cervical canal and
internal os. Cervical dilators are commonly used on post-menopausal patients with
cervical stenosis.
Contraindications
Cervical dilators should not be used when the following conditions are present:
• Acute genital track or pelvic infections.
• A pregnancy or the suspicion of a pregnancy.
• Any invasive cancer that is visible upon examination.
• Any non-compliant patient.
Precautions
• Check the packaging for damage which can compromise sterility.
• Visually inspect the dilators for any surface damage prior to use.
• Disposable cervical dilators 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.
• Cervical dilators should not be used for prolonged periods of time.
Adverse Reactions
The following risks are possible during procedures requiring dilation:
• Laceration of the cervix
• Tears of the internal os
• Perforation of the fundus
• False passage at the internal os
Instructions
Dilation of the cervix may be required for many diagnostic and treatment
procedures. This procedure should always be performed by a medical professional
who is trained in the procedure and aware of all possible complications and risks
that may be present.
1. A pelvic examination of the patient should be performed prior to dilation to
determine conditions present and risks of dilation.
2. The insertion of a weighted speculum may assist with visualization of the cervix.
3. Uterine tenaculum forceps should be used to grasp the cervix. Stabilization
of the tenaculum should be maintained during the dilation procedure to
absorb resistance and avoid trauma to surrounding anatomical structures.
4. The Os Locator is used to gently dilate the external os to allow access to the
cervical canal. Holding the dilator like a pen, gently insert the dilator into the
external os. Slight, slow movements can be used to break up connective tissues
that may exist. Proceeding slowly allows the os to gently stretch to accommodate
the dilator.
5. The Canal dilator is often needed next to continue the dilation of the cervical
canal to gain access to the internal os. The canal may become atrophic and rigid
in post menopausal patients. Proceeding slowly using the technique referenced
above, allows the canal to gently stretch over the dilator.
6. The Fundus Sound is utilized to complete the dilation of the internal os and
palpate the depth of the uterus. Continuing to hold the dilator like a pen,
dilation of the internal os should also proceed slowly to allow the tissues
to gently stretch over the dilator. Care should be exercised to minimize the risk
of perforation of the uterus or tearing of the internal os.
7. If additional dilation is required, the use of progressively larger diameter dilators
can be utilized following the same process allowing for slow dilation of
the cervix to accommodate instrumentation needed for the procedure.
8. If resistance is met to any size dilator, it is advisable to leave it in the internal
os for several seconds to allow the tissues to expand around it.
Symbols
Symbols may be used on some package labeling for easy identification.
Integra
®
Miltex
®
Disposable Cervical Dilators
Directions for Use
Product complies with
requirements of directive 93/42/
EEC for medical devices
Single use only
Expiration date
Method of sterilization:
ethylene oxide
Federal (USA) law restricts this
device to sale by or on the order
of a physician or practitioner
EC REP
REF
Manufacturer 1
Authorized Representative
in the European Community
Catalog number
Lot Number
See instructions for use - Caution
Consult IFU and website address
LOT
0434
0434
EXP
1 Company responsible for a device marketed under its own name regardless of
whether “manufactured for” or “manufactured by” the company.
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
Integra, the Integra logo, and Miltex are registered trademarks of Integra LifeSciences
Corporation or its subsidiaries in the United States and/or other countries. ©2012 Integra
LifeSciences Corporation. All Rights Reserved. SURG-IFU-CERVDT Rev. A 05/12
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