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Vercise Gevia MRI
92126470-01A
2017-08
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ii
M365DB12000 Vercise Gevia MRI DBS IPG
NM-3138-55 8 Kit 55
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iii
1 1 1 1
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iv
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v
..........................................................................................................1 ......................................................................................................... 1
.................................................................................................................. 1IPG ................................................................................2
IPG ..................................................................................................2DBS ................................................................................................ 2DBS ..................................................... 2
..................................................................4DBS .................................................. 4IPG ............................................................................................................ 6
MRI DBS ....................8DBS ................................................................................................ 8
.......................................................................... 9IPG ....................................................................................... 9
MRI DBS IPG .............................................................10IPG ...........................................................................................................11
IPG ......................................................... 12IPG .......................................................................... 13
...............................................................................14 .....................................................................................14 ....................................................................................15
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vi
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1
MRI DBS (IPG Vercise Gevia IPG )IPG DBS
MRI DBS IPG 2 DBSDBS IPG
DBS DBS DBSDBS
DBSIPG
IPG
IPG
• IPG• IPG• IPG (2 )•
: ( )
(55cm)
• • • ( )•
: ( )
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2
IPGIPG IPG IPG
IPG IPGIPG IPG
2
IPGDBS1. DBS DBS2. DBS
3. DBS4.
:
5. DBS
DBS
DBS
1. 1 2
DBS
DBS
DBS
:
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3
2. DBS DBS
DBSDBS
3. DBSDBS
: DBS
4. 5. 1 3 2 DBS 2
6. DBSDBS
"Intraoperative Testing ( )"7. 8.
:
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4
1.
a. b.
c.
DBS1. DBS IPG
: MRI IPG MRI DBS
Boston ImageReady™ MRI
a. b.
: IPG
c. 2cm 0.5cm 2cmIPG
2. 3.
:
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5
4. IPG
: ( )
5.
: 6.
7.
8. 2
9.
:
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6
IPG
C D
1. IPGa. IPGb.
c. d.
:
2. IPG
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7
: ( )
3. a. IPGb.
4. IPG5.
IPG
:
:
:
6. 1 5 2 IPG 22 IPG 1
IPG 27. This Side Up ( )
IPG
: IPG
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8
a. IPG
: IPGIPG
b. IPG IPG8.
: DBS IPG
:
MRI DBS
MRI DBS (IPG DBS) ( ) DBS
IPG
DBS: MRI DBS
DBS1. IPG2. (BHC)3. BHC BHC DBS DBS
4. BHC 2 3cm DBS5. BHC6. DBS
DBS
7. 8. DBS
9.
:
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9
10. DBS11. DBS
: DBS
12. DBSMRI DBS " "
1. IPG2. 3. DBS
4. ( )5.
: DBS
:
6.
7. "IPG " IPG
8. IPG
: DBS
: IPG
IPG1. IPG2. IPG3. IPG
: IPG
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10
: IPG
4. IPG5.
:
:
6. IPG7. IPG "IPG " IPG8.
9.
:
MRI DBS IPGIPG
• • • •
IPG IPGIPG
24IPG
IPG "IPG "IPG MRI DBS
(CP) 1 24MRI DBS
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11
IPG
IPG1.
2. IPG
3. IPGIPG
a. IPGIPG
: IPG
b. IPG IPG
c.
d. e. f. IPG
IPG
IPGIPG
:
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12
:
a.
b. (1)
c. IPG
IPG
: ( : )
4. 2 IPG
: IPG(2 )
: IPG
IPGIPG
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13
IPG2
IPG 2 DBS2 DBS
IPG 1
:
1: IPG
1 0.1 20mA2, 3 2 255Hz
4 20 450μs
( ) 1 90
1 10
16
(41 4 ) 16
1 12.7mA
20mA 11 12.7mA
7.3mA2 255Hz3 250Hz
( )4 60 450 s
( )
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14
88 DBS DBS
( )IPG DBS
2:
55cm
1.35mm
8
DBS
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Vercise GeviaTM
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ii
1 1 1 1
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iii
MRI DBS ..................................... 1
.................................................................................1 ..............................................................................................1
......................................................................1
.......................................................................... 2
.......................................................................................................2 .................................................................................................2
................................................................................4 .........................................................................................8
2 (ETS 2) ................................. 10
................................................. 10
...................................................................................... 11
............................................................................................ 17
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iv
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1
MRI DBSMRI DBS
DBS DBSMRI
DBS DBS 1 8 ( )
Vercise Neural Navigator
: MRI DBS
MRI DBS
( )
• • •
• •
• IPG:
• : 119kHz 131kHz• : FSK• : 0.05mW (-13dBm)• ( 3m): 46 A/m
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2
MRI DBS
: MRI DBS
: MRI DBS
: MRI DBS
: (status dystonicus) (
)DBS
DBS () DBS
( )
:
:
DBS
:
: MRI DBS
MRI DBS
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3
(MRI): MRI DBS MRIImageReady™ MRI
1.5T ()MRI MRI
MRI DBS MRIBoston Scientific ImageReady™ MRI
: ((ETS) ETS OR
) MR Unsafe MRI MR
:
•
• ()
• • • • • (RF) (LoJack
)
• RF
: (CISPR)
: DBS
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4
:
:
: DBS
: ( MRI IPG )( )
: MRI DBS
MRI DBS
DBS
: DBS ()
DBS
: MRI DBS
:
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5
: MRI DBS
(CP) MRI DBSMRI DBS
: 2cm This Side Up ( )
( )
:
DBS
: DBSDBS DBS
: DBS
: DBS
(4 )
:
:
: 2
( )
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6
:
DBS
:
:
• DBS
•
•
•
•
• MRI DBS
• CT
CT•
:
: 1
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7
DBS
• •
• •
• •
: ETS 10 40 (50°F 104°F) 35 (95°F)
: 0 45 (32°F 113°F)
( ETS OR) -20 60 (-4°F 140°F)
( )
DBS
![Page 34: Vercise Gevia MRI 7Á 'G GyGGGFG5G[GzG GM · 2020. 5. 21. · m365db12000 vercise gevia mri dbs ipgg;gqgv nm-3138-55 8gag gmg=gvgxg gwg6g=gggtg gegug kit 55 ú ô g b ñ $ Ü3¸g](https://reader030.vdocument.in/reader030/viewer/2022013023/5fc58661c2fb00620176503b/html5/thumbnails/34.jpg)
8
• DBS• DBS• DBS
DBS• DBS
• ( ) DBS
:• •
:
:
• • (
)• (CSF)• ( )• ( )• (
)
![Page 35: Vercise Gevia MRI 7Á 'G GyGGGFG5G[GzG GM · 2020. 5. 21. · m365db12000 vercise gevia mri dbs ipgg;gqgv nm-3138-55 8gag gmg=gvgxg gwg6g=gggtg gegug kit 55 ú ô g b ñ $ Ü3¸g](https://reader030.vdocument.in/reader030/viewer/2022013023/5fc58661c2fb00620176503b/html5/thumbnails/35.jpg)
9
• ( )( )
• ( )• • ( (
) ( ) )• • ( )
• • ( )• (
)• • MRI DBS
ImageReady™ MRI• (
)• • ( )• ( )• • (CT )• • • • • (
)• ( )
( )• • (
)•
![Page 36: Vercise Gevia MRI 7Á 'G GyGGGFG5G[GzG GM · 2020. 5. 21. · m365db12000 vercise gevia mri dbs ipgg;gqgv nm-3138-55 8gag gmg=gvgxg gwg6g=gggtg gegug kit 55 ú ô g b ñ $ Ü3¸g](https://reader030.vdocument.in/reader030/viewer/2022013023/5fc58661c2fb00620176503b/html5/thumbnails/36.jpg)
10
2 (ETS 2)ETS 2
1: (ETS) 2
ETS 2 ETS 2 ON/OFF ( 1)ETS 2 ETS 2
3 2
()
:
1.
2. ETS 23. 4. 3 2 (+) (-)5.
6. 15
1 15 30 1 23 4
1 24
2
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11
BS EN 60601-1-2
Precision™ Montage SCS MRI DBS 1999/5/EC
• • • • II
MRI DBSMRI DBS
RF CISPR 11
1 MRI DBSRF
RF
RF CISPR 11
B MRI DBS
IEC 61000-3-2
B
IEC 61000-3-3.
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12
MRI DBSMRI DBS
IEC 60601
(ESD) IEC 61000-4-2
6kV8kV
6kV8kV
30%
: IPG
() IEC
61000-4-4
2kV1kV
2kV1kV
IEC 61000-4-5 1kV2kV
1kV2kV
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13
IEC 61000-4-11
<5% UT
(UT >95% )0.5
40% UT
(UT 60% )5
70% UT
(UT 30% )25
<5% UT
(UT >95% )5
<5% UT
(UT >95% )0.5
40% UT
(UT 60% )5
70% UT
(UT 30% )25
<5% UT
(UT >95% )5
MRI DBS
MRI DBS
(50/60Hz)
IEC 61000-4-8
3A/m 30A/m
UT AC
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MRI DBSMRI DBS
IEC 60601
RFMRI DBS
( )
RFIEC 61000-4-6
3Vrms150kHz 80MHz
3Vrms150kHz 80MHzISM
a
d=1.2
6Vrms150kHz 80MHzISM
a
d=0.58
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RFIEC 61000-4-3
3V/m80MHz 2.5GHz
10V/m80MHz 2.5GHz
d=0.35 80MHz 800MHzd=0.70 800MHz 2.5GHz
P
(W) d(m)
b
RF
c
1 80MHz 800MHz2
a 0.15MHz 80MHz ISM ( ) 6.765MHz 6.795MHz 13.553MHz13.567MHz 26.957MHz 27.283MHz 40.66MHz 40.70MHz 0.15MHz 80MHz
1.8MHz 2.0MHz 3.5MHz 4.0MHz 5.3MHz 5.4MHz 7.0MHz 7.3MHz10.1MHz 10.15MHz 14MHz 14.2MHz 18.07MHz 18.17MHz 21.0MHz 21.4MHz 24.89MHz24.99MHz 28.0MHz 29.7MHz 50.0MHz 54.0MHzb ( ) AM FM
RFMRI DBS
RF MRI DBS
MRI DBS
c 150kHz 80MHz 3V/m
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RF MRI DBS
MRI DBS RFMRI DBS
RF ( )MRI DBS
( )
RFCISPR 11
W
150kHz 80MHzd=1.2
ISM ()
150kHz 80MHzd=0.58
ISM
80MHz 800MHzd=0.35
800MHz 80GHzd=0.70
0.01 0.12 0.06 0.04 0.07
0.1 0.37 0.18 0.11 0.22
1 1.2 0.58 0.35 0.70
10 3.7 1.8 1.1 2.2
100 12 5.8 3.5 7.0
150kHz ( RFID )1.17m
(m) dP
(W)
1 80MHz 800MHz
2
MRI DBS 1999/5/EC
Industry Canada ( ) :
Industry Canada RSS2
1. 2.
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91168761-01 REV A 2016-1191168753-01 REV A 2016-11