CooperSurgical Pipelle 8200 Instrucciones De Uso página 2

INDICATIONS FOR USE
Histologic biopsy of the epithelium and glandular mucosal layer (endometrium)
of the uterine wall or sample extraction of uterine menstrual content for:
• Detection of endometrial carcinoma and precancerous conditions
• Determination of endometrial tissue response to hormonal influences by
visual observation of the histologic sample, such as:
a. Endometrial dating
b. Periodic scrutiny of the effects of hormonal therapy on the uterine
endometrium, particularly in patients receiving estrogen replacement
therapy for menopausal symptoms and prophylaxis of osteoporosis
c. Luteal insufficiency (visually determined histologically from endometrial
tissue obtained only during the secretory [progestational] phase of the
menstrual cycle)
d. Functional metrorrhagia (contraception, pre-menopause)
• Diagnosis of pathology associated with infertility
• Bacterial culturing to specifically identify causative uterine pathogens
CONTRAINDICATIONS
®
The Pipelle
suspected of being pregnant.
PRECAUTIONS
By virtue of its flexibility and small caliber, with the Pipelle a histologic
endometrial biopsy can be performed with minimal danger of uterine wall
perforation. However, care should be taken prior to its insertion to ascertain the
depth of the uterus and any uterine retroflexion or anteflexion present in
individual patients. Best clinical judgement should be used to allow for any
variations from anatomical norms during insertion and in no case should the
instrument be forced against digitally felt resistance.
If passage of the Pipelle through the cervical canal is not found to be easily
achievable, the instrument should not be forced and the possibility of the
presence of pathologic cervical stenosis considered. With elderly patients in
whom an extremely dry cervix may cause resistance to the instrument's
passage, very slight lubrication of the sheath with a sterile water soluble gel
may facilitate its insertion.
ADVERSE REACTIONS
The following adverse reactions have been occasionally suspected or
reported. The order of listing does not indicate frequency or severity.
• Injury to uterus (perforation)
• Cramping
• Uterine spasm
DIRECTIONS FOR USE
1. Prepare the vagina and cervix using currently accepted antiseptic
techniques as you would for any intrauterine procedure.
2. With the vaginal speculum in place and open to expose the uterine cervix,
gently probe the uterus for both its depth and direction with a uterine
sound. DO NOT USE the Pipelle as a uterine sound. Then grasp the
cervix with a very fine forceps or a tenaculum. If the uterus is anteverted,
this grasp should be applied to the anterior lip of the cervix. If the uterus
should not be used in patients who are pregnant or in patients
8200-DFU • Rev. A • 1/14