MRI Head and Extremity Scans

MRI Head and
Extremity Scans
for the Senza System
®
Patients with the Senza system can safely undergo MRI
head and extremity scans under specific conditions
Key MRI Examination Requirements
•M
RI scan should be performed on the head or extremities only
•A
ll spinal cord stimulation (SCS) components should be outside of the RF head
coil or other transmit/receive RF volume coil (wrist coil, knee/foot coil, etc.)
•M
aximum specific absorption rate (SAR) and maximum gradient field should be
set to the guidelines in the MRI labeling
•F
or the full labeling, refer to the Senza MRI guidelines or visit
www.nevro.com/ous/mri
Key MRI Equipment Requirements
•T
he MRI should be performed on a 1.5T or 3T cylindrical bore machine
•U
se only a transmit/receive RF head or other transmit/receive RF
volume coil (wrist coil, knee/foot coil, etc.)
Patients can experience durable back and
leg pain relief with HF10™ therapy 1 — now
with access to MRI head and extremity scans
MR Conditional
Detailed information for
MRI head and extremity scans
with the Senza system
• Use only a 1.5 or 3 Tesla cylindrical bore MRI system
TRANSMIT/RECEIVE
RF HEAD COIL
CYLINDRICAL
CLOSED BORE 1.5T
OR 3T MR SCANNER
PATIENT IMPLANTED
WITH NEVRO SENZA
SYSTEM
•U
se only a transmit/receive RF head coil or other
transmit/receive RF volume coil (wrist coil, knee/foot
coil, etc.)
• Limit
the gradient dB/dt field to 200 Tesla per meter
per second per axis or less
•U
se MRI examination parameters that limit the head
specific absorption rate (SAR) level lower than 3.2 W/kg
• Conduct wrist MR scans with wrist placed above the head as shown in the diagram
•N
o part of the implanted system (implantable pulse
generator [IPG], extensions, or leads) may be within
the RF transmit/receive head coil and other RF
transmit/receive volume coils
TRANSMIT/RECEIVE
RF WRIST COIL
CYLINDRICAL
CLOSED BORE 1.5T
OR 3T MR SCANNER
PATIENT IMPLANTED
WITH NEVRO SENZA
SYSTEM
•D
o not perform an MRI if the patient has a device
or device component from a different manufacturer
attached to the Nevro IPG
•D
o not conduct an MRI if there are any lead fragments
or leads not connected to the Nevro IPG (“orphan
leads”) in the patient
•D
o not perform an MRI if any contact impedance is
greater than 10 kOhms
• Ensure
that MR-conditional labeling from all implanted
devices are followed
• Stimulation must be turned OFF
PATIENT IMPLANTED
WITH NEVRO SENZA
SYSTEM
CYLINDRICAL
CLOSED BORE 1.5T
OR 3T MR SCANNER
• Limit total scan time to 15 minutes
For the full labeling, refer to the Senza MRI
guidelines or visit www.nevro.com/ous/mri
TRANSMIT/RECEIVE
RF KNEE COIL
Reference
1. Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency
spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study
[published online ahead of print Dec 5 2013]. Pain Med. 2013. doi: 10.1111/pme.12294.
Do not perform an MRI until the full labeling has been read and understood
Nevro Corp.
Effective
4 May 2010
NOT FOR SALE IN USA
MDSS GMBH
Schiffgraben 41
D-30175 Hannover,
Germany
Australian Sponsor:
Emergo Asia Pacific Pty Ltd
201 Sussex Street, Darling Park,
Tower II, Level 20
Sydney, NSW 2000
Australia
4040 Campbell Avenue, Suite 210
Menlo Park, CA 94025 USA
www.nevro.com
Senza, HF10, Nevro, and the Nevro logo are trademarks of Nevro Corp.
© 2015 Nevro Corp. All Rights Reserved.
2014002 Rev. B