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- 4 -

Date of Manufacture

Attention, Consult Accompanying Documents

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

PD110090 Rev. A 
Revised 2012-11

 

Summary of Contents for Azur CX 35

Page 1: ...gle use only Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in...

Page 2: ...timate the size of the lesion to be treated 9 For aneurysm occlusion the diameter of the first and second coils should never be less than the width of the aneurysm neck or the propensity for the coils...

Page 3: ...otating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher which could result in coil migration Angiographic assessment should also be perf...

Page 4: ...ction including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Batteries are pre...

Page 5: ...age 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...

Page 6: ...use reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illnes...

Page 7: ...will allow for fluoroscopic road mapping during the procedure 6 Select a microcatheter with the appropriate inner diameter After the microcatheter has been positioned inside the lesion remove the guid...

Page 8: ...the introducer sheath Excessive tightening could damage the device 23 Push the coil into the lumen of the microcatheter Use caution to avoid catching the coil on the junction between the introducer s...

Page 9: ...e risk of aneurysm or vessel rupture Do NOT advance the delivery pusher once the coil has been detached 43 Verify the position of the coil angiographically through the guide catheter 44 Additional coi...

Page 10: ...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 diagnos...

Page 11: ...ation of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may...

Page 12: ...e may be increased For vessel occlusion it is suggested that the diameter of the initial coil placed be slightly larger than the actual vessel diameter to prevent displacement or migration For aneurys...

Page 13: ...catheter tip from moving away from the intended delivery location 20 Once the coil has been deployed and prior to removing the delivery catheter advance the guidewire through the catheter tip to verif...

Page 14: ...sequential 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 o...

Page 15: ...device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a risk of contamination of the device and or caus...

Page 16: ...er with the appropriate inner diameter After the microcatheter has been positioned inside the lesion remove the guidewire COIL SIZE SELECTION 7 Perform fluoroscopic road mapping 8 Measure and estimate...

Page 17: ...ppropriately sized coil Movement of the coil may indicate that the coil could migrate once it is detached DO NOT rotate the delivery pusher during or after delivery of the coil into the vasculature Ro...

Page 18: ...of the patient Batteries are pre loaded into the Azur Detachment Controllers Do not attempt to remove or replace the batteries prior to use After use dispose of the Azur Detachment Controller in a man...

Page 19: ...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...

Page 20: ...PD110323 Rev A 1 MicroVention Inc Instructions for Use Detachable...

Page 21: ...sitioned in the vessel or aneurysm within the specified reposition time from the time the device is first introduced into the microcatheter If the coil cannot be positioned and detached within this ti...

Page 22: ...ation replace the device If the green light remains solid green for the entire three second observation continue using the device 15 Hold the device just distal to the shrink lock and pull the shrink...

Page 23: ...The coil implant has been determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials ASTM International Designation F2503 08 Non clinical...

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