Terumo Azur CX 35 Instructions For Use Manual Download Page 5

- 5 -

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 2015 Terumo Corporation.  All rights reserved.

Terumo

 and Azur

 are registered trademarks of Terumo Corporation. 

MicroVention

®

 is a registered trademark 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  
265 Davidson Avenue, Suite 320 
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 

PD111138 Rev. A 

Revised 2015-06

 

 

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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