Smiths Medical Wallace Mode D'emploi page 2

English
Wallace® Intra-uterine
Insemination Catheters
INSTRUCTIONS FOR USE
Wallace® intra-uterine insemination catheters are single-use
devices provided sterile for the introduction of washed
spermatozoa into the uterine cavity.
These instructions contain important information
for safe use of the product. Read the entire contents
of these Instructions For Use, including Warnings
and Cautions, before using this product. Failure to
properly follow warnings, cautions and instructions
could result in death or serious injury to the patient
and/or clinician.
NOTE: DISTRIBUTE THIS INSERT SHEET TO ALL
PRODUCT LOCATIONS.
WARNING:
•
THESE PROCEDURES SHOULD ONLY BE
PERFORMED BY PERSONS HAVING ADEQUATE
TRAINING AND FAMILIARITY WITH THESE
TECHNIQUES. CONSULT MEDICAL LITERATURE
REGARDING TECHNIQUES, COMPLICATIONS AND
HAZARDS PRIOR TO PERFORMANCE OF THESE
PROCEDURES.
•
TO BE USED BY, OR UNDER THE DIRECTION
OF, QUALIFIED PERSONS IN LINE WITH
LOCAL GUIDELINES GOVERNING IN VITRO
FERTILISATION, IF APPLICABLE.
•
DISCARD IF PRODUCT OR PACKAGING IS
DAMAGED.
Description
These instructions are intended for use with sterile Wallace®
intra-uterine insemination catheters, product code AIC18.
The devices consist of a flexible inner catheter and an outer
sheath which is attached to the inner catheter by a Luer
compatible connector.
The inner catheter is 16g with a lumen that is uniform
throughout its length, and capable of containing 0.2ml of
fluid. The catheter has 2 side eyes located at the smooth,
closed distal tip.
The inner catheter protrudes from the outer sheath by 5cm,
and the outer sheath has a series of 1cm graduations at the
distal end.
Indications for use
Introduction of washed spermatozoa into the uterine cavity.
(Intra-uterine artificial insemination)
Contraindications
The catheter should not be used:
•
In the presence of chronic cervical infection
•
In the presence of or after recent pelvic
inflammatory disease
•
For intra-fallopian procedures
Instructions for Use
1 Place patient in the lithotomy, dorsal, or left lateral
position. The cervix should be exposed with a speculum
and gently swabbed with cotton wool moistened with
normal saline or medium.
When using transabdominal ultrasound follow normal
procedures such that an optimal image of the uterine
cavity is achieved.
2 With the plunger fully depressed firmly attach a syringe
(preferably 3ml or 5ml) to the inner catheter.
3 Draw 1ml of air into the syringe, then place the distal tip of
the catheter into the specimen of washed spermatozoa so
that both lateral ports are immersed. Aspirate the desired
quantity of specimen into the catheter.
2
WARNING
-
Always use washed spermatozoa when performing
intra-uterine insemination. The introduction of
unwashed spermatozoa into the uterus will almost
always result in severe adverse reaction which may
include anaphylactic shock. Refer to medical literature
for methods of preparing spermatozoa for intra-uterine
insemination before performing this procedure.
4 With the hubs locked in position, advance the catheter so
that the inner catheter passes through the external and
internal os, into the mid-uterine cavity. It may be necessary
to twist the catheter as it negotiates the cervical canal.
When using ultrasound manipulate the probe to obtain
the best image of the inner catheter.
WARNING
The catheter should never be forced against digitally
felt resistance while inside the uterine cavity, as forcing
the catheter may result in damage to the endometrial
tissue and bleeding.
The outer sheath should not be advanced further than
the internal os, and should certainly never enter the
uterine cavity, as this may result in damage to the
endometrial tissue and bleeding.
The inner catheter tip should not be pulled back
further than the end of the outer sheath, as this
may result in damage to the endometrial tissue and
bleeding.
5 If slight resistance is experienced, withdraw the catheter
and advance the outer sheath until only the tip of the inner
catheter is visible. Using thumb and forefinger curve the
outer sheath to complement the patient's anatomy and
pass the catheter in this position to the internal os. In the
rare event where the cervical canal cannot be negotiated
by this method, stylets are available to assist insertion. Use
code no 1816ST. Advance the inner catheter into the mid-
uterine cavity.
6 Place tip of catheter approximately 1cm from the fundus
and slowly inject the washed spermatozoa and 1ml of air
in the syringe to ensure full expulsion of the specimen.
Should there be any doubt about the complete expulsion,
remove the syringe from the catheter; reload with air;
reattach the syringe and slowly inject the air to expel any
remaining specimen.
7 Leave time for the uterine environment to equilibrate and
slowly remove the catheter.
8 Remove the speculum and allow the patient to rest.
9 Dispose of the catheter in accordance with local medical
hazardous waste practices.
The above are only suggested instructions for use. The
final decision on the technique used is the responsibility
of the clinician in charge.
References
[1] Lopata A, Patullo MJ, Chang A, James B 1976
A method for collecting motile spermatozoa from
human semen. Fertil Steril 27:677
Wallace, Wallace design mark and Smiths Medical design mark
are trademarks of Smiths Medical. The symbol ® indicates
the trademark is registered in the U.S. Patent and Trademark
Office and certain other countries. All other names and marks
mentioned are the trade names, trademarks or service marks of
their respective owners.
© 2014 Smiths Medical. All rights reserved.
[1]
3