Intended Use/Indications - IPAS MVA Plus Manual Del Usuario

Device Descriptions
The Ipas manual vacuum aspiration (MVA) system consists
of an aspirator and cannulae. Differences in aspirators and
cannulae are noted in Instrument Characteristics on
pages 3–4.
Description of Aspirators
The Ipas aspirators consist of two models: the Ipas MVA
Plus ® , and the Ipas Single-Valve aspirator. Each aspirator
has a cylinder, plunger, and valve. Depending on the
model, each aspirator fits a variety of sizes of cannulae.
Adapters are required for some aspirator-cannulae
combinations. Ipas aspirators are clean, not sterile, when
shipped. Ipas aspirators and adapters are multiple-use
devices.
Description of Cannulae
The Ipas cannulae consist of three models: the Ipas
®
EasyGrip cannulae, the flexible Karman cannulae, and
the Ipas 3mm cannulae. Each cannula, depending on its
size, has either one (9, 10, 12mm) or two (3, 4, 5, 6, 7,
8mm) apertures. Each cannula is sterilized with ethylene
oxide after packaging and remains sterile until the stated
expiration date, as long as the package is intact. Ipas
EasyGrip cannulae are multiple-use devices. Ipas 3mm and
flexible Karman cannulae are single-use devices.

Intended Use/Indications

All Ipas aspirators and cannulae are intended for uterine
aspiration/uterine evacuation in obstetrics and gynecologic
patients. Clinical indications for uterine aspiration with this
product are: treatment of incomplete abortion for uterine
sizes up to 12 weeks from last menstrual period (LMP), and
endometrial biopsy.
Applications for endometrial biopsy may include cases
of infertility, abnormal uterine bleeding, amenorrhea,
and screening for endometrial cancer or screening for
endometrial infections.
Contraindications
Endometrial biopsy should not be performed in
cases of suspected pregnancy. There are no known
contraindications for treatment of incomplete abortion for
uterine sizes up to 12 weeks LMP.
Ipas Aspirators
plunger
handle
cylinder
base
Ipas Aspirators are mulitple-use devices
Ipas Cannulae
base
wing
base
(removable)
Ipas cannulae (from top to bottom):
the Ipas EasyGrip cannula, the Ipas 3mm
cannula and the flexible Karman cannula
with adapter.
Where regulations allow, Ipas EasyGrip
cannulae and adapters are reusable
after undergoing high-level disinfection
or sterilization.
Flexible Karman cannulae are single-use
devices. After use, treat soiled cannulae as
infectious waste.

cap release
tabs
valve buttons
collar stop
clasp
retaining
collar
clip
stop
plunger O-ring
cylinder base
plunger arms
valve
cylinder
collar
stop
valve
liner
plunger
O-ring
plunger
aperture
dots
lines
wing dots
adapters
cap
valve
button
aperture
aperture