CooperSurgical MX120 Gebrauchsanweisung

MX120 & MX124 • Uterine Explora
Curette with Sharp Randall-Type Cutting Edge and Vacu-Lok Syringe
Instructions for Use (English)
DEVICE DESCRIPTION
The MX120 (3 mm) and the MX124 (4 mm) curettes are used to obtain clearly differentiated
endometrial tissue, usually without anesthesia, in an office setting.
The flexibility of the nylon curette, the small diameter, and the sharp Randall-Type cutting edge allow
better sampling from all areas of the endometrial cavity, including the cornual areas. The rounded end
of this curette minimizes the possibility of perforation.
WARNINGS
• Contents supplied sterile. Do not use if sterile barrier is damaged.
• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization
may compromise the structural integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create
a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Dispose
of in accordance with all applicable Federal, State and local Medical/Hazardous waste practices.
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician.
PRECAUTIONS
• Sounding of the uterus and the ensuing curettage should be performed with due care to avoid perforation of the uterine wall.
• NEVER use force to introduce the curette into the cervical canal.
• In cases where there is a marked cervical stenosis, Dilateria
the cervical os) prior to performing the procedure.
• Any cervical manipulation may cause a vaso-vagal reaction. Patient should be watched for evidence of unusual pallor, nausea,
vertigo or weakness. These symptoms will generally respond to about 3 to 10 minutes of rest and/or mild analgesic.
• In rare cases there may be spotting and mild cramping after the procedure has been performed. The patient should be instructed to
contact her physician if bleeding persists or if a low grade fever is present.
• DO NOT DEPRESS SYRINGE PISTON WHILE CANNULA-CURETTE IS IN THE UTERUS.
INDICATIONS FOR USE
• Detection of endometrial hyperplasia
• Detection of endometrial cancer
• Initial endometrial biopsy prior to prescribing estrogen replacement therapy to ensure endometrial lining is normal
• Periodic monitoring of endometrial tissue in women receiving estrogen replacement therapy
• Endometrial dating
• Examination of glandular epithelium to determine ovulation and endometrial response to hormonal excretion and therapy
• Detection of pathology resulting in infertility
• Secondary Amenorrhea
• Monitor patient receiving TAMOXIFEN therapy for breast cancer
CONTRAINDICATIONS
• Patients where pregnancy is suspected
• Patients with, or recently recovered from, pelvic inflammatory disease
• Patients with any cervical or pelvic infections (infections should be treated and cured before performing any endometrial
sampling procedure)
• Patients suffering from any diseases or conditions which could under all circumstances contraindicate outpatient surgical treatment –
e.g. severe anemia, heart disease, or clotting mechanism deficiencies
INSTRUCTIONS FOR USE
1. Prepare vaginal area and cervix as you would for any sterile intrauterine procedure.
2. With a vaginal speculum in place and the cervical os visible, carefully sound the uterus with the sound curved in the direction of the
canal, to determine both the position and the depth of the uterine cavity. In only an extremely small percentage of cases is anesthesia
and/or premedication necessary. Advise patient that there may be a minimum amount of discomfort when the curette is first introduced.
3. It may be necessary to use a tenaculum to grasp the cervix and apply gentle traction to straighten the endocervical canal. To stabilize
the cervix in those women with an anteverted uterus, grasp the anterior lip of the cervix with a tenaculum; if the uterus is retroverted,
grasp the posterior lip of the cervix and apply gentle traction to straighten the cervical curvature.
4. After determining the depth of the uterine cavity, adjust the yellow sliding collar on the curette.
NOTE: Cutting edge of Explora Curette is aligned with the imprinted graduated markings and the index point (flattened surface at the
base of curette).
Curette • Model I
™
(Laminaria japonica) should be considered for use (to soften and dilate
™
1