Cooper Surgical SM610 MiniSpace Handbuch

SM610 • MiniSpace
IUI Catheter
For intrauterine artificial insemination
WARNING: NEVER ATTEMPT TO RESTERILIZE.
MOUSE EMBRYO ASSAY (MEA) 2-CELL SURVIVAL >80%
This device is not intended for use for intrafallopian tube procedures,
In vitro fertilization (IVF) and Gamete intrafallopian transfer (GIFT).
DEVICE DESCRIPTION
The MiniSpace ® IUI Catheter is a single-use, sterile,
disposable, flexible catheter designed for use in
intrauterine insemination. The opening is at the tip of
the catheter which has been rounded and beveled
for the comfort of the patient.
The device has an overall length of 19.9 cm
including a 2.7 cm long polyethylene Luer-lock hub
which is permanently affixed to its proximal end.
The effective portion of the catheter (intended for
insertion) comprises a 17.2 cm long clear
polyethylene tube with a 1.6 mm O.D. (outer
diameter) and a 0.7 mm I.D. (inner diameter). When
filled, the MiniSpace contains 0.07 ml of fluid.
The proximal 12.7 cm length of the catheter is tightly
surrounded by a clear polypropylene sheath with a
2.6 mm O.D. for all but the distal 1 mm length, which
joins the inner tube to the outer sheath. At this 1 mm
joining length, the O.D. tapers inward from 2.6 mm
to 1.6 mm over the 1 mm spindle-shaped portion.
This leaves 4.5 cm of the inner catheter tube
exposed at the distal end.
The proximal inner tube and the outer sheath
circumference are molded directly onto the distal
end of the Luer-lock hub so that only the lumen of
the inner tube can provide a channel for flow. This
design results in a single-channel catheter with two
segments each having different degrees of flexibility
(i) a highly flexible 1.6 mm O.D., 4.5 cm long distal
portion and (ii) a more rigid 2.6 mm O.D., 12.7 cm
long proximal portion.
Graduation markings are at 5, 6, 7, 8, 9, and 10 cm
distance from the extreme distal tip of the catheter.
INDICATIONS FOR USE
Intrauterine artificial insemination
CONTRAINDICATIONS
The MiniSpace shall not be used in:
• pregnant patients or in patients suspected of
being pregnant
• the presence of acute or chronic cervical
infection
• the presence of, or after recent Pelvic
Inflammatory Disease (PID)
WARNINGS
ALWAYS PREPARE THE SPERMATOZOA TO
SEPARATE THE MOTILE SPERM FROM THE
® Instructions for Use (English)
Length: 17.2 cm (effective) 19.9 cm (overall)
O.D.:
I.D.:
2.6 mm stepped down to
1.6 mm for distal 4.5 cm of length
0.7 mm for the 17.2 cm effective length
REST OF THE SEMEN SAMPLE BEFORE
PERFORMING INTRAUTERINE INSEMINATION
(INCLUDING INTRACERVICAL
INSEMINATION) USING, FOR EXAMPLE, THE
®
Sperm Select SYSTEM.
THE INTRODUCTION
SPERMATOZOA INTO THE UTERUS WITH
THE MiniSpace OR BY ANY OTHER MEANS
WILL ALMOST ALWAYS RESULT IN SEVERE
ADVERSE REACTIONS, WHICH MAY INCLUDE
ANAPHYLACTIC SHOCK. PLEASE REFER TO
PUBLISHED MEDICAL LITERATURE FOR
METHODS OF PREPARING SPERMATOZOA
FOR INTRAUTERINE INSEMINATION BEFORE
PERFORMING THIS PROCEDURE .
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
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.
PRECAUTIONS
Due to its flexibility, small diameter, spindle-shaped
rounded tip, the MiniSpace can be introduced into
the uterus with minimal risk of uterine wall
perforation.
However, CARE SHOULD BE TAKEN prior
to catheter insertion to ascertain the depth of the
uterus and any uterine retroflexion or anteflexion
present in each patient. (This should be performed
during a previous examination and not on the day of
insemination when disturbance of the uterus should
be minimized.)
IN NO CASE shall the device be forced against
resistance. If passage of the MiniSpace through the
cervical canal cannot be achieved, the device should
not be forced and the possibility of pathologic cervical
stenosis should be considered. IN NO CASE should
air be injected into the uterine cavity.
R x Only
ARTIFICIAL
OF UNWASHED
or cross-infection,
SM610-DFU • Rev. A • 3/14