GEM COUPLER Instructions D'utilisation page 15

DISCLAIMER OF WARRANTY:
EN
Synovis Micro Companies Alliance, Inc., a subsidiary of Baxter
International Inc. warrants that reasonable care has been used in
the manufacture of this device. This warranty is exclusive and in
lieu of all other warranties whether expressed, implied, written
or oral, including, but not limited to, any implied warranties
of merchantability or fitness. Since SMCA has no control over
the conditions under which the device is used, diagnosis of the
patient, methods of administration or its handling after it leaves
its possession, SMCA does not warrant either a good effect or
against an ill effect following its use. The manufacturer shall
not be liable for any incidental or consequential loss, damage or
expense arising directly or indirectly from the use of this device.
SMCA will replace any device which is defective at the time of
shipment. No representative of SMCA may change any of the
foregoing or assume any additional liability or responsibility in
connection with this device.
REFERENCES:
1. DeLacure M and Wang H: Magnetic Resonance Imaging
Assessment of a Microvascular Anastomotic Device for
Ferromagnetism. Journal of Reconstructive Microsurgery 13:8,
1997.
2. Caution needed when performing MRI scans on patients with
aneurysm clips. FDA Medical Bulletin Volume 23, Number 2,
June 1993.
3. Synovis MCA Internal report, V-0718R rev A, Coupler MR
Compatibility Verification Report.
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