Integra LifeSciences Cannula, Endo Biopsy, SoftFlex(TM) and FirmFlex(TM) - Manual

30-3010 SoftFlex Endo Biopsy Cannula
30-3012 FirmFlex Endo Biopsy Cannula
Description
The sterile (ETO) Endo Biopsy Cannula is used to obtain a sample from the uterine
mucosal lining. The Endo Biopsy Cannula is a 3mm outer diameter (O.D.) suction
curette and is sterile unless the package is opened or damaged. The Endo Biopsy
Cannula is designed for single use only.
Indications
Endometrial suction currettes, such as the Endo Biopsy Cannula, are devices 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
purposes 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
Endo Biopsy Cannula.
• 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 piston of
the Endo Biopsy Cannula while it is in the uterus.
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 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 Endo Biopsy
Cannula paying close attention to the embossed scale on the Endo Biopsy
Cannula sleeve. This will provide additional caution against perforation.
5. With the piston completely depressed, the Endo Biopsy Cannula should be
inserted and gently passed through the cervical canal and into the cavity
of the uterus. Discontinue any traction applied with a tenaculum.
6. With one hand holding the proximal end of the Endo Biopsy Cannula and
the other hand holding the piston handle, rapidly withdraw the piston by
pulling back on the handle, creating a vacuum or suction within the Endo
Biopsy Cannula. The withdrawal motion should be smooth but quick and
steady until the piston reaches the end-stop built into the Endo Biopsy
Cannula. Leave the piston in its fully withdrawn position.
7. After the piston has been retracted, immediately rotate the Endo Biopsy
Cannula (either twirl or roll) between the fingers while moving the Endo
Biopsy Cannula back and forth and side to side within the uterine cavity.
Continue this sweeping motion at least three or four times to obtain an
adequate sample.
8. The Endo Biopsy Cannula should be gently removed from the uterus.
Upon examination of the device, you should see a specimen or sample
from the uterine mucosal lining. Bleeding is usually minimal, if it occurs
at all.
9. Cut off the tip of the Endo Biopsy Cannula just above the sampling point
of the device. The sampling point is the small hole at the distal end of the
Endo Biopsy Cannula.
10. Push the piston back into the sleeve of the Endo Biopsy Cannula,
and the specimen should be easily expelled into an appropriate
transfer vial.
Symbols
Symbols may be used on some package labeling for easy identification.
Integra
®
Miltex
®
SoftFlex ™ Endo Biopsy Cannula
FirmFlex ™ Endo Biopsy Cannula
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
0434
0434
EXP
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.
SoftFlex and FirmFlex are trademarks of Integra LifeSciences Corporation or its subsidiaries
©2012 Integra LifeSciences Corporation. All Rights Reserved.
SURGENDOCANDFU 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.