Precision Novi™ - Boston Scientific- US · 2019. 9. 18. · SC-1140 Precision Novi™ Ü3¸G...

Precision Novi™

2017-5

92043207-01A

i

( )

SCS

SC-1140 Precision Novi™

ii

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Precision Novi IPG .............................................................................................. 2

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IPG .............................................................................. 5

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IPG ................................................................................................................ 5

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IPG ............................... 8

IPG .................................................................................................10

IPG ...................................................................................................................................10

1

Precision Novi (IPG)

IPG

IPG IPG

Precision Novi 16 : 8 2 16 1 16 (2x8) 1

Precision Novi

Artisan™ 2x8

82x42x8

: xx

2

Precision Novi IPG

(1) (1) (1) (1) IPG(2)

)

3

( )

4

( ) 4

0

2 1200ppsa 40pps

20 1000 secb 210 sec

1 90

1 10 3

1 16 : +100% -100% 1 16 :

a. 130pps 1b. C

3 ( )

IPG BSC S1140

5

IPG

• IPG• • IPG• IPG

• IPG 0°C 45°C(32°F 113°F)

IPG

1. ( )2. (ETS)

( )

IPG

1.

2. 3. IPG IPG

IPG4. IPG IPG

5. IPG: IPG

IPG

6

1.

2.

3. 4. :5. 6.

7

7.

8.

9.

10.

8

11.

:

: 2x8

IPG

IPG

IPG :• IPG C D•

1 8) C9 16) D

• Artisan 2x8 C( ) 9 16 D

9

1. IPG

2. IPG:

( )

:

IPG3. IPG

:

:

: 4. IPG5. IPG

10

6. IPG IPG

:

7.

IPG

1. IPG2. IPG

3.

4. "IPG "(8 ) IPG

IPGPrecision Novi IPG

IPG IPG (EOS)

IPG

Precision Novi™

i

SCS

ii

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

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Precision Novi IPG ....................................................................................... 16

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1

Precision Novi (IPG)OR

Precision Novi• • 16• 1 4 16

• • • •

(SCS)• SCS• • •

:

(MRI) : Precision Novi SCS MRI

MRIIPG

IPGPrecision Novi ( ) MRI

2

Precision Novi MRIPrecision Novi MRI

MRI

:

: SCSIPG

IPG: SCS IPG

IPGIPG : IPG

:

IPG: IPG

: IPG

• (EAS )

IPG

• • • •

3

IPGIPG

( EAS )

SCS:

IPG

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)• •

CT

CT IPG"

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:

: 2

4

• 2.27kg(5 )•

• 2

2

IPG : IPGIPG

IPG

: IPG

: IPG

IPG

: 10 40°C (50 104°F) Precision Novi IPG 8°C

IPGIPG 8°C

:

( )

5

-20 60°C(-4 140°F)

:

:

:

IPG• : • :

•

• IPG• (CSF)

6

•

• MRI IPG

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•

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:

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CT

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7

Precision Novi

• : » IPG ) » IPG )

• : 1.5

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5 5 IPG

»5

5 »

Precision Novi( )

: 119 131kHzRF )

(ETS IPG)

RC )

2RC

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8

• • RFID

Precision Novi )Precision Novi

" "

360°

360

1:

RF )

3)

)

2:

9

Precision NoviPrecision Novi

RF CISPR 11 1 Precision NoviRF

RF

RF CISPR 11 B Precision Novi

IEC 61000-3-2B

IEC 61000-3-3

10


IEC 60601

(ESD) IEC 61000-4-2

± 6 kV± 8 kV

± 6 kV± 8 kV

30%

IEC 61000-4-4

± 2 kV± 1 kV

± 2 kV± 1 kV

IEC 61000-4-5

± 1 kV

± 2 kV

± 1 kV

± 2 kV

11

IEC 61000-4-11

<5% UT

(>95% UT )0.5

40% UT

(60% UT )5

70% UT

(30% UT )25

<5% UT

(>95% UT )5

<5% UT

(>95% UT )0.5

40% UT

(60% UT )5

70% UT

(30% UT )25

<5% UT

(>95% UT )5

Precision Novi™

Precision Novi

IEC 61000-4-8

: UT

12


IEC 60601

RFPrecision Novi

RFIEC 61000-4-6 150kHz

80MHz150kHz80MHz

RFIEC 61000-4-3 80MHz

2.5GHz

80MHz2.5GHz

80MHz 800MHz

800MHz 2.5GHz

P(W)

a

RF

b

13

1 80MHz 800MHz2

a ( )AM FM TV

RFPrecision Novi

RF Precision Novi

Precision Novi

b 150kHz 80MHz

14

RF Precision NoviPrecision Novi RF

Precision NoviRF (

) Precision Novi

(m)

RFCISPR 11

(W)

150kHz 80MHzd=1.2 P

80MHz 800MHzd=1.2 P

800MHz 80GHzd=2.3 P

0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.17 1.17 2.3310 3.69 3.69 7.38100 11.67 11.67 23.33

150kHz ( RFID )

P (W)

1 80MHz 800MHz2

15

Precision Novi

•

• • • • • •

: (EO)

16

Precision Novi IPGPrecision Novi IPG IPG

• ()

• • • 1•

Precision Novi IPG 1 1(12 24 )

1

Precision Novi(" " )

: Precision NoviPrecision Novi IPG

: Precision Novi IPG

1 Bionic Navigator™ 3D

30 s 1(12 ) 2( 24 )

30 s 3(12 ) 4(

24 )1 4

12

17

1: 1 12 >30μs

2: 1 24 >30μs

18

3: 1 12 30μs

4: 1 24 30μs

19

:

*

276 s 43Hz 1.55 3434

13 1: 12

5.2

* Oakley Stimulation Power by Disease Diagnosis in Spinal Cord Stimulation (2006 )

IPG(ERI) IPG

IPGIPG

ERI 12(ERI) 4

IPG IPG

IPG (EOS)

IPG

Precision Novi 12Precision Novi 12

20

• - 61

1• - 6

IPG

91005926-01 REV D 2017-0391005929-01 REV B 2015-07

Precision Novi™ - Boston Scientific- US · 2019. 9. 18. · SC-1140 Precision Novi™ Ü3¸G...

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