Indications For Use; Contraindications - Smiths Medical Wallace TT1816 Gebrauchsanweisung

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Wallace®
Trial Transfer Catheter
INSTRUCTIONS FOR USE
Wallace® trial transfer catheters are closed ended single-use devices
provided sterile and should only be used to assess the passage
through the cervix prior to embryo transfer.
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.
•
THIS CATHETER IS NOT OPEN ENDED AND NOT FOR
EMBRYO TRANSFER. ONLY TO BE USED TO TEST
PASSAGE OF CATHETER THROUGH THE CERVIX IN A
NON-TREATMENT CYCLE.
•
DISCARD IF PRODUCT OR PACKAGING IS DAMAGED.
Description
These instructions are intended for use with sterile Wallace® trial
transfer catheters, product codes
Catheter Type Length
Classic 18cm
Classic 23cm
Sure View® *
18cm
Sure View® * 23cm
*Sure View® – for enhanced visibility under ultrasound.
The devices consist of closed inner catheter and a detachable outer
sheath that is attached to the inner catheter by a Luer compatible
adapter. The inner catheter is 16g with a series of 1cm graduations
at the proximal end. The inner catheter protrudes from the outer
sheath by 5cm and the outer sheath has a series of 1cm graduations
at the distal end. The material of the Sure View® inner catheter is
modified to contain small bubbles that improve ultrasound image
quality.

Indications for use

To determine whether the cervix is passable for a Wallace® embryo
replacement catheter

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
Cautions
Low resolution ultrasound equipment or use of 'Classic' embryo
catheters may compromise the visibility of the catheter.
When performing transabdominal ultrasound, ensure that the
patient has a full bladder.
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Code
TT1816
TT1816N
CE418
CE423
Instructions for Use
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.
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 should not be pulled back further than the
last graduation. Removing it from the outer sheath completely
may result in damage to the endometrial tissue and bleeding.
If slight resistance is experienced, withdraw the catheter and
advance the outer sheath until only the tip of the inner catheter is
visible. Aligning the most distal marking on the base of the inner
catheter with the hub of the outer sheath ensures a smooth radius
protrudes. 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. Advance the inner catheter into the mid-
uterine cavity. In the rare event where the cervical canal cannot be
negotiated by this method, stylets are available to assist insertion.
Use code no 1816ST with 18cm catheters and 1816NST with 23cm
catheters.
Place tip of catheter approximately 1cm from the fundus. Assess the
passage of the catheter in preparation for embryo transfer.
Remove and 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.
* The products described are covered by one or more of the following:
U.S. Patent No. 8,092,390 and counterpart foreign patent(s). Pat
pending. Patent applied for.
Sure View, 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.
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