- 5 -
scanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software
14X.M5, General Electric Healthcare, Milwaukee, WI) MR system.
Therefore, the MRI-related heating experiments for the coil
implant at 3 Tesla using a transmit/receive RF body coil at an MR
system reported whole body averaged SAR of 2.9 W/kg (i.e.,
associated with a calorimetry measured whole body averaged
value of 2.7 W/kg) indicated that the greatest amount of heating
that occurred in association with these specific conditions was
equal to or less than 1.7°C.
Image Artifact Information
MR image quality may be compromised if the area of interest is in
the exact same area or relatively close to the position of the coil
implant. Therefore, optimization of MR imaging parameters to
compensate for the presence of this device may be necessary.
Terumo Corporation recommends that the patient register the MR
conditions disclosed in this IFU with the MedicAlert Foundation or
equivalent organization.
MATERIALS
The Azur system does not contain latex or PVC materials.
SYMBOLS
Lot Number
Order Number
Content
Sterilized Using Irradiation
Sterilized Using Ethylene Oxide
Do Not Reuse
Use-by Date
Date of Manufacture
Attention, Consult Accompanying Documents
Type BF Applied Part
Power ON and OFF
CE Mark
Manufacturer
Authorized European Representative
MR Conditional
Non-pyrogenic
Upper limit of temperature
WARRANTY
Terumo warrants that reasonable care has been used in the
design and manufacture of this device. This warranty is in lieu of
and excludes all other warranties not expressly set forth herein,
whether expressed or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of
merchantability or fitness for particular purpose. Handling,
storage, cleaning, and sterilization of the device as well as factors
relating to the patient, diagnosis, treatment, surgical procedure,
and other matters beyond Terumo’s control directly affect the
device and the results obtained from its use. Terumo’s obligation
under this warranty is limited to the repair or replacement of this
device through its expiration date. Terumo shall not be liable for
any incidental or consequential loss, damage or expense directly
or indirectly arising from the use of this device. Terumo neither
assumes, nor authorizes any other person to assume for it, any
other or additional liability or responsibility in connection with this
device. Terumo assumes no liability with respect to devices
reused, reprocessed or resterilized and makes no warranties,
expressed or implied, including, but not limited to, merchantability
or fitness for intended use, with respect to such device.
Prices, specifications, and model availability are subject to
change without notice.
© Copyright 2012 Terumo Corporation. All rights reserved.
Terumo
and Azur
are registered trademarks of Terumo Corporation.
MicroVention
®
and HydroCoil
®
are registered trademarks of MicroVention, Inc.
Manufacturer:
MicroVention, Inc.
1311 Valencia Avenue
Tustin, CA 92780 USA
Tel: 714.247.8000
www.microvention.com
Distributed by:
Terumo Medical Corporation
2101 Cottontail Lane
Somerset, NJ 08873
Tel: (800) 862-4143
Authorized European Representative:
MicroVention Europe
30 bis, rue du Vieil Abreuvoir
78100 Saint-Germain-en-Laye
France
Tel: +33 (0)1 39 21 77 46
Fax: +33 (0)1 39 21 16 01
0297
PD110088 Rev. B
Revised 2012-11
Pulse Sequence:
T1-SE
T1-SE
GRE
GRE
Plane Orientation: Parallel
Perpendicular Parallel
Perpendicular
Signal Void Size:
511 mm
2
80 mm
2
633 mm
2
179 mm
2
