vercise gevia mri 7Á 'g gygggfg5g[gzg gm · 2020. 5. 21. · m365db12000 vercise gevia mri...

44
Vercise Gevia MRI 㟁ᘧ䝟䝹䝇䝆䜵䝛䝺䞊䝍 ㄝ᭩ 92126470-01A 2017-08

Upload: others

Post on 19-Aug-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: 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

Vercise Gevia MRI

92126470-01A

2017-08

Page 2: 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

ii

M365DB12000 Vercise Gevia MRI DBS IPG

NM-3138-55 8 Kit 55

Page 3: 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

iii

1 1 1 1

Page 4: 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

iv

Page 5: 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

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

Page 6: 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

vi

Page 7: 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

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)

• • • ( )•

: ( )

Page 8: 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

2

IPGIPG IPG IPG

IPG IPGIPG IPG

2

IPGDBS1. DBS DBS2. DBS

3. DBS4.

:

5. DBS

DBS

DBS

1. 1 2

DBS

DBS

DBS

:

Page 9: 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

3

2. DBS DBS

DBSDBS

3. DBSDBS

: DBS

4. 5. 1 3 2 DBS 2

6. DBSDBS

"Intraoperative Testing ( )"7. 8.

:

Page 10: 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

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.

:

Page 11: 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

5

4. IPG

: ( )

5.

: 6.

7.

8. 2

9.

:

Page 12: 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

6

IPG

C D

1. IPGa. IPGb.

c. d.

:

2. IPG

Page 13: 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

7

: ( )

3. a. IPGb.

4. IPG5.

IPG

:

:

:

6. 1 5 2 IPG 22 IPG 1

IPG 27. This Side Up ( )

IPG

: IPG

Page 14: 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

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.

:

Page 15: 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

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

Page 16: 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

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

Page 17: 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

11

IPG

IPG1.

2. IPG

3. IPGIPG

a. IPGIPG

: IPG

b. IPG IPG

c.

d. e. f. IPG

IPG

IPGIPG

:

Page 18: 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

12

:

a.

b. (1)

c. IPG

IPG

: ( : )

4. 2 IPG

: IPG(2 )

: IPG

IPGIPG

Page 19: 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

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

( )

Page 20: 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

14

88 DBS DBS

( )IPG DBS

2:

55cm

1.35mm

8

DBS

Page 21: 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

15

Page 22: 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

16

Page 23: 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

Vercise GeviaTM

Page 24: 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

ii

1 1 1 1

Page 25: 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

iii

MRI DBS ..................................... 1

.................................................................................1 ..............................................................................................1

......................................................................1

.......................................................................... 2

.......................................................................................................2 .................................................................................................2

................................................................................4 .........................................................................................8

2 (ETS 2) ................................. 10

................................................. 10

...................................................................................... 11

............................................................................................ 17

Page 26: 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

iv

Page 27: 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

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

Page 28: 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

2

MRI DBS

: MRI DBS

: MRI DBS

: MRI DBS

: (status dystonicus) (

)DBS

DBS () DBS

( )

:

:

DBS

:

: MRI DBS

MRI DBS

Page 29: 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

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

Page 30: 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

4

:

:

: DBS

: ( MRI IPG )( )

: MRI DBS

MRI DBS

DBS

: DBS ()

DBS

: MRI DBS

:

Page 31: 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

5

: MRI DBS

(CP) MRI DBSMRI DBS

: 2cm This Side Up ( )

( )

:

DBS

: DBSDBS DBS

: DBS

: DBS

(4 )

:

:

: 2

( )

Page 32: 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

6

:

DBS

:

:

• DBS

• MRI DBS

• CT

CT•

:

: 1

Page 33: 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

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

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

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

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

Page 37: 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

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.

Page 38: 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

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

Page 39: 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

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

Page 40: 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

14

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

Page 41: 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

15

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

Page 42: 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

16

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.

Page 43: 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

17

Page 44: 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

91168761-01 REV A 2016-1191168753-01 REV A 2016-11