CooperSurgical Wallace DNS1633-950 Notice D'utilisation page 2

English
Dual Lumen Oocyte Recovery System
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
NOTE: DISTRIBUTE THIS INSERT SHEET TO ALL PRODUCT LOCATIONS.
Description
These instructions are intended for use with sterile Wallace® Dual Lumen Oocyte
Recovery System, product codes:
Code
DNS1633-950
DNS1633-750
DNS1633-500
DNS1733-950
DNS1733-750
DNS1733-500
The devices consist of a dual lumen stainless steel needle with 1cm of echo
marking at the distal end. Attached to the proximal end are a plastic hub and a
tubing set. The tubing set consists of a transfer tube leading through a silicone
bung, and a vacuum tube also passing through the bung and terminating in
a Luer compatible connector. Attached to the plastic hub is a flushing tube,
terminating in a clear Luer compatible connector.
The silicone bung is compatible with test tubes within the following
specifications:
Smallest Diameter - 14.0mm
Largest Diameter - 18.0mm
A pump adaptor is supplied in the pack to connect the vacuum tube to a vacuum
source (if required), and is compatible with elastic tubing internal diameter 4mm-
10.5mm.
Indications for use
The Wallace® Dual Lumen Oocyte Recovery System is a sterile single-use device
for ultrasound-guided, transvaginal collection of oocytes from the ovarian
follicles.
Certification of Analysis
• 1 - Cell MEA ≥ 80% blastocysts within 96 H
• Endotoxin LAL ≤ 20 EU/device
Note: The result of each batch are stated on a certificate of Analysis which is
available at www.origio.com
Contraindications
The Dual Lumen Oocyte Recovery System should not be used:
In the presence of or after recent pelvic inflammatory disease.
For intra-fallopian procedures.
Warnings
READ THE COMPLETE DIRECTIONS FOR USE BEFORE USE.
FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS AND
CAUTIONS MAY LEAD TO SERIOUS SURGICAL CONSEQUENCES OR
INJURY TO THE PATIENT.
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.
THE SHARP NEEDLE MUST BE HANDLED CAREFULLY TO AVOID
NEEDLE-STICK INJURY, WHICH MAY RESULT IN TISSUE DAMAGE OR
CROSS-INFECTION.
DISCARD IF PRODUCT OR PACKAGING IS DAMAGED.
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician.
2
Wallace®
INSTRUCTIONS FOR USE
in death or serious injury to the patient and/or clinician.
16g 33cm dual lumen needle with 95cm transfer tubing
16g 33cm dual lumen needle with 75cm transfer tubing
16g 33cm dual lumen needle with 50cm transfer tubing
17g 33cm dual lumen needle with 95cm transfer tubing
17g 33cm dual lumen needle with 75cm transfer tubing
17g 33cm dual lumen needle with 50cm transfer tubing
Description
en