Integra LifeSciences Endometrial Sampling Set, Disposable Curette and Syringe - Manual

30-3015 Endometrial Sampling Set (1 syringe and 1 curette)
Description
The sterile (ETO) Endometrial Sampling Set is used to obtain a sample of
differentiated endometrial tissue for screening and culturing. The Endometrial
Sampling Set has a 3mm outer diameter (O.D.) endometrial suction curette
with a Randall-like cutting edge at its distal end and is packaged with a twist-
and-lock syringe. The syringe provides vacuum or suction during the
procedure. The Endometrial Sampling Set is sterile unless the package is
opened or damaged. It is designed for single use only.
Indications
The Endometrial Sampling Set is used to remove samples of materials from the uterus
and from the mucosal lining of the uterus by scraping or vacuum suction. These
devices obtain tissue samples for purpose of biopsy precancer screenings or for
menstrual extraction.
Contraindications
The procedure is contraindicated in suspected pregnancy or in women with
acute pelvic inflammatory disease. It is also contraindicated in women with
chronic cervical infections or any conditions that contraindicate an outpatient
surgical procedure.
Warnings
• In general, any patient with cervical stenosis requires extreme
precautions. Do not use force when using this device with these
patients. You may use a topical anesthetic prior to the use of the
Endometrial Sampling Set.
• Be aware of, and look for, adverse reactions that are occasionally
encountered in any intrauterine procedure.
Precautions
• While sounding the uterus and using this device, care should be taken to
avoid perforation of the uterine wall.
• Do not depress the syringe’s piston while it is in the uterus.
• To lock piston in place, turn piston 1/4 turn clockwise.
Adverse Reactions
• Patients should be carefully watched for evidence of unusual paleness,
nausea, vertigo, or weakness. Any cervical manipulation may cause a
vasovagal reaction. These symptoms typically subside in about
15 minutes with rest and/or a mild analgesic.
• In some cases, there may be spot bleeding or mild cramps after this
procedure has been performed. The patient should be instructed to
notify the physician if spotting continues or if a persistent fever
develops.
Instructions
1. Prepare the vagina and cervix as you would for any sterile intrauterine
procedure.
2. Expose the cervix using a suitable speculum.
3. Gently insert a uterine sound to determine the depth and direction of the
uterine cavity. It may be necessary to grasp the cervix with a tenaculum.
If the uterus is anteverted, the grasp should be on the anterior lip of the
cervix. If the uterus is retroverted, the grasp should be on the posterior lip
of the cervix. Apply gentle traction to straighten any cervical curvature.
4. After the depth of the cervix has been determined, insert the curette,
paying close attention to the embossed scale on the curette sleeve or use
the enclosed “stopette”. This will provide additional protection against
perforation.
5. With the piston of the Endometrial Sampling Set’s syringe completely
depressed, the curette should be inserted and gently passed through
the cervical canal and into the cavity of the uterus. Discontinue any
traction applied with a tenaculum. Carefully attach the syringe to the
base of the curette. Please note: The “arrow” at the proximal end of
the curette is aligned with the cutting edge or sampling curette point
of the distal end.
6. With one hand holding the proximal end of the curette, withdraw the
piston of the syringe with your free hand, creating a vacuum within
the curette. The withdrawal motion should be smooth and steady
until the piston reaches the end stop of the syringe. Now grasp the
piston syringe close to the blue locking mechanism and lock the
piston in place by turning the piston 1/4 turn clockwise. Test to be sure
the piston is secured in its locked position. When locked, the syringe
will provide adequate vacuum or suction during the procedure.
7. After the piston has been retracted and locked to provide a vacuum or
suction, rotate the curette through all four quadrants of the endometrium
by using long, slow strokes.
8. The curette should be gently removed from the uterus. Upon
examination of the device, you should see a specimen or sample from
the endometrium of histological quality. Bleeding is usually minimal,
if it occurs at all.
9. Cut off the tip of the curette just above the sampling point of the device.
The sampling point is the entrance port with the Randall-like cutting edge
at the distal end of the curette. Unlock the syringe by turning the syringe
piston 1/4 turn counterclockwise and expel the specimen into an
appropriate transfer vial.
Symbols
Symbols may be used on some package labeling for easy identification.
Integra
®
Miltex
®
Endometrial Sampling Set
Disposable Curette & Syringe
Directions for Use
Product complies with
requirements of directive 93/42/
EEC for medical devices
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
Single use only
EC REP
Manufacturer 1
Authorized Representative
in the European Community
Catalog number
Lot number
Caution: see warnings
or precautions
Consult instructions for use and
website address
EXP
0434
0434
EXP
Sterilized Using
Ethylene Oxide
EU Representative
Wellkang Ltd
i Suite B, 29 Harley Street i LONDON, W1G 9QR, U.K.
EC REP
Manufactured for
Integra York PA, Inc.
i 589 Davies Drive, York, PA 17402 USA
866-854-8300 USA i +1 717-840-2763 outside USA i +1 717-840-9347 fax
integralife.com/integra-miltex
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
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.
SURGENDOKITDFU Rev. A 05/11
1 Company responsible for a device marketed under its own name regardless of whether
“manufactured for” or “manufactured by” the company.