Page 188 of 191
800581-2.11 NeurOne System User Manual.doc
A
A
P
P
P
P
E
E
N
N
D
D
I
I
X
X
1
1
4
4
:
:
M
M
R
R
C
C
O
O
N
N
D
D
I
I
T
T
I
I
O
O
N
N
A
A
L
L
S
S
T
T
A
A
T
T
E
E
M
M
E
E
N
N
T
T
O
O
F
F
C
C
O
O
M
M
P
P
L
L
I
I
A
A
N
N
C
C
E
E
F
F
O
O
R
R
N
N
E
E
U
U
R
R
O
O
N
N
E
E
T
T
E
E
S
S
L
L
A
A
A
A
M
M
P
P
L
L
I
I
F
F
I
I
E
E
R
R
,
,
B
B
A
A
T
T
T
T
E
E
R
R
Y
Y
P
P
A
A
C
C
K
K
A
A
N
N
D
D
A
A
C
C
C
C
E
E
S
S
S
S
O
O
R
R
I
I
E
E
S
S
NeurOne System parts: Tesla amplifier, battery pack, Bipolar Connection Box and MRI EEG
cap have been demonstrated to be MR Conditional
The MR Conditional marking information is based on non-clinical testing in various MRI
environments. The guideline for testing has based on the standards:
ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced
Heating On or Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213 Standard Test Method for Measurement of Magnetically Induced
Torque on Medical
ASTM F2052 Standard Test Method for Measurement of Magnetically Induced
Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from
Passive Implants
Tests have demonstrated that stated NeurOne system parts are conditional with listed MRI
scanners. Listed scanners are suitable for working with NeurOne system without any fore
seeable operational issues of the scanner having a negative effect on the MR conditional
labeled NeurOne system parts or vice versa.