CooperSurgical Pipelle 8200 Instrucciones De Uso

8200 • Pipelle
DESCRIPTION
The Pipelle ®
a histologic biopsy of the uterine mucosal lining or sample extraction of uterine
menstrual content for microscopic examination or culturing.
The device consists of a clear, flexible, polypropylene sheath that is 26.5 cm
(overall) 23.5 cm (effective) length with a 3.1 mm OD (Outside Diameter) and
a 2.6 mm ID (Internal Diameter). The sheath is marked with colored, graduated
markings from 4 cm to 10 cm, distance from the distal tip of the sheath to
indicate the depth of insertion of the sheath into the uterus during use (see
diagram below).
B 4 cm
A
The 4, 7, 8, and 10 cm point depth markings on the sheath are accentuated
and numbered. At 4 mm from the distal tip of the sheath is the center of the
curette opening (A) which is 1.93 mm in diameter. This opening has sharp
edges and leads to the lumen of the sheath. An EVA piston (B) affixed to the
distal end of a soft acetal resin rod (E) can be moved forward and backward
within almost the full length of the lumen of sheath. This is accomplished by
manipulation of the knob (F) affixed to the proximal end of the piston rod which
extends beyond the proximal end of the sheath. The piston is prevented from
being totally pulled from within the sheath by means of an indentation (D) in
the sheath located 1 cm from its proximal end. An orientation mark (C)
indicates the position of the curette opening.
Rapid movement of the piston within the sheath from its fully inserted position to
its maximum retracted position creates a negative pressure (suction) within the
lumen of the sheath. This negative pressure draws the mucosal tissue through
the curette opening and into the lumen of the sheath as the curette scrapes
against the endometrial wall while it is maneuvered within the uterine cavity.
WARNINGS
• In patients with amenorrhea, obtaining an endometrial biopsy with the Pipelle
should be performed only after confirmation of the absence of detectable
circulating HCG levels.
• 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.
®
Endometrial Suction Curette
Instructions for Use (English)
is a single-use, sterile, disposable, suction curette for obtaining
8 cm
10 cm
7 cm
C E F
D
8200-DFU • Rev. A • 1/14