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Bionic NAVIGATOR™ 䉸䊐䊃䉡䉢䉝 䉧䉟䊄 SC-7150SC-7150-4NM-7152-12 Clinician Programmer (CP) Bionic NAVIGATOR 䉸䊐䊃䉡䉢䉝 䉧䉟䊄 2 ᧄ䊙䊆䊠䉝䊦䈲䇮⧷⺆ 䊙䊆䊠䉝䊦䉕㇌⸶䈚䈢ขᛒ⺑ᦠ䈪䈜䇯ຠ䈮ห䈘䉏䈩䈇䉎ઃᢥᦠ䈏ᧄ ㇌䈮ᣈ䈔䉎⮎ᴺ䈱ᱜᑼ䈭ᢥᦠ䈫䈭䉍䉁䈜䇯䉴䊕䊷䉴䈱⚂䇮ઃᢥᦠ䈪䈲⚦䈭ขᛒᣇᴺ╬ 䉕✂⟜䈪䈐䈭䈇䈢䉄䇮ຠ䉕䈗↪䈮䈭䉎೨䈮䈲ᧄ䊙䊆䊠䉝䊦䉕䈗ᾫ⺒䈇䈢䈣䈐䉁䈜䉋䈉䈍㗿䈇↳䈚 䈕䉁䈜䇯 ᧄ䊙䊆䊠䉝䊦䈱ᵈᗧ㗄䈮䈚䈩↪䈘䉏䈢႐ว䈮䈲䇮ᑷ␠䈲ㅧ⽿છ䈠䈱䈱ᴺ⊛⽿છ䉕⽶䈋 䈭䈒䈭䉎႐ว䈏䈅䉍䉁䈜䇯 © 2011 Boston Scientific Corporation or its affiliates. All Rights Reserved. 1957 3 11 ᣣ䈱ᴺᓞ䈱᧦㗄䈮䉋䉏䈳䇮ᧄᢥᦠ䈱ኈ䈱䈜䈼䈩䉁䈢䈲৻ㇱ䉕 Boston Scientific Corporation 䈱ᦠ㕙䈮䉋䉎␜⊛䈭⸵น䈭䈚䈮ⶄ౮䇮ⶄ䇮䉁䈢䈲⠡⸶䈜䉎䈖䈫䈲෩ኒ䈮䈛䉌䉏䈩䈇䉎䇯 NMT-003 90851363-01A

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Page 1: Bionic NAVIGATOR™ BxB B BaBbB] BgB B

Bionic NAVIGATOR™

SC-7150 SC-7150-4 NM-7152-12 Clinician Programmer (CP)

Bionic NAVIGATOR 2

© 2011 Boston Scientific Corporation or its affiliates. All Rights Reserved. 1957 3 11Boston Scientific Corporation

NMT-003

90851363-01A

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Bionic NAVIGATOR™ SC-7150 SC-7150-4 NM-7152-12 Clinician Programmer (CP)

:

1 Clinician Programmer (CP) .......................................................................................................................................... 3

................................................................................................................................................................................................ 3 ...................................................................................................................................................................................... 3

................................................................................................................................................................................................... 4 ....................................................................................................................................................................................................... 4

2 VAS .................................................................................................................. 6 ............................................................................................................................................................................ 6

OR .............................................................................................................................................................................................. 6 VAS ................................................................................................................................................................................................................. 7

3 ................................................................................................................................................................ 8 ...................................................................................................................................................................................................... 8

............................................................................................................................................................................................................... 8 ................................................................................................................................................................................................................ 8

........................................................................................................................................................................................ 9 ........................................................................................................................................................................................................ 9

4 ..................................................................................................................................................... 10 ................................................................................................................................................................................. 10

.......................................................................................................................................................................... 10 ( ) .............................................................................................................................................................................................. 11

........................................................................................................................................................................................... 11 ..................................................................................................................................................................................................... 12

5 ...................................................................................................................... 14 .................................................................................................................................................................................. 14

Navigator ........................................................................................................................................................................... 14 OR ............................................................................................................................................................................................ 16

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

Remote Control ............................................................................................................................................................................................ 18 ........................................................................................................................................................................................ 19

6 ...................................................................................................................................................................... 20 7 .......................................................................................................................................................................... 21

.......................................................................................................................................................................................... 21 OR ............................................................................................................................................................................................ 21

: Precision™ Precision

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1 Clinician Programmer (CP)

Bionic NAVIGATOR™ NMT-003 3 / 24

1 Clinician Programmer (CP)

CP

PC 3 PC

Windows

[Windows ]

[ ] [X]

CP CP

PC PC

[ ]

(<–)

www.toshiba.com Portege

3500 M200 M400 M750 PC

Clinician Programmer (CP) Remote Control

StimulatorCP

Remote Control

CP [ ] Bionic Navigator™

1. SEL 1 SEL 2 Remote Control [ ]

2. [ - ABC]

3. P Remote Control [ ]

4. "CP Mode"

Remote Control [CP Ready] Remote ControlIR IR

Stimulator Remote Control 60cm (2 )

Clinician Programmer (CP) IRRemote Control IR

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Bionic Navigator™ Controller

[OFF]

"Mark"

Clinician Programmer (CP)

(PC)

PC " "

[Sync Data]

PC " "

Clinician Programmer (CP) PCMCIA

[START]

/

[Sync Data] [Select All]

[ ]

[delete]

Boston Scientific

" "

system

Remote Control language

Stimulator

[System] " "

[OK]

[Cancel]

Stimulator Remote Control

[System]

[Backup Data/Logs]

[Add Lead] Stimulator Remote Control

[System Info] [EGL Scan]

[ ]

- "CLINIC"

Backup Data/Logs -

[OK]

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1 Clinician Programmer (CP)

Bionic NAVIGATOR™ NMT-003 5 / 24

[Add Lead]

- Boston Scientific

[OK] [Cancel]

[Import]

Stimulator Clinician Programmer (CP)

[System Info] Stimulator Remote Control

[OK]

EGL Scan™

EGL Scan

[EGL Scan] - EGL Scan Stimulator

- EGL Scan External Trial Stimulator (ETS)

EGL Scan EGL Scan

[Print] EGL Scan [Cancel]

[ ]

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2 VAS

Patient Profile

" " [Profile]

[Manual] Navigator [Finish] [Next]

[Profile]

( ) Patient Profile

[ ]

[Manual] Navigator "Coverage Area"

" " 1 [ ]

( )

(RES) [RES]

[VIEW]

Remote Control VAS

OR

OR Mapping

OR (E-Troll)

Boston Scientific SC-2108-xx

"OR "

[OR Mapping] [Finish]

E-Troll E-Troll

E-Troll

[E-Troll] [ ] [ ]

[ ]

3

1

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2 VAS

Bionic NAVIGATOR™ NMT-003 7 / 24

E-Troll

[Electrodes] - (+) 1 - (-) 2 - (0) 3

[ ]

X

X

VAS

VAS " " " "

" " " " Bionic Navigator™ VAS

( ) ( )

VAS

Profile

Manual Navigator Remote VAS VAS [OK]

[Cancel]

[ ] [ ]

[ ]

0 10

VAS VAS

VAS Reports VAS

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3

" " [Profile] [Case History]

[OK]

Reports Profile " " Start

Start

OR Navigator 3 ( )

( )

Bionic Navigator™

[Start] "Start " [ ]

Bionic Navigator

[Patient Name]

[New Patient]

[Reason for Visit]

OR Mapping Manual Navigator Remote Control

Remote Reports

Start Start Bionic Navigator

Help

Config Profile Sync Data

Notes

" " Profile [Notes]

- CP PC

[OK] [Cancel] Profile

Case History

Reports

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3

Bionic NAVIGATOR™ NMT-003 9 / 24

Profile

VAS

" "

[Profile] Start [patient name]

[new patient]

ProfileStart

Start[Patient Name]

Start Profile

1. CP PC

2. [Finish] "Start "

Graphic Module

VAS OK

Notes

Case History

Report

" "

[Reports] [Finish]

[ ]

VAS

() /

[Qualifiers] [Create a Report] print export

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4

Battery Status Stimulator ( )

" "

[Remote] [Battery] Remote Control [OK]

Stimulator [Measure]

5

25

Remote Control24

Stimulator Reports

Hardware Configuration Summary

Stimulator Remote Control(

)

" "

[Config] Hardware Configuration

Summary

Start [Finish]

[Modify]

-Stimulator " " Stimulator 1-L 2-R

Stimulator[Connections]

[SWAP] Stimulator[OK]

Connections [OK] [Cancel]

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4

Bionic NAVIGATOR™ NMT-003 11 / 24

( )

3 Navigator

" "

[Config]

Hardware Configuration Summary Modify

[Finish]

Lead Model

[ ] 2

[Next] 2Lead Configuration 1Lead Orientation

Lead Configuration

[ ] [Next]

Lead Orientation

[Retrograde]

[Vertebral Control]

[Next] [Finish] Start

Hardware Configuration Summary

Hardware Configuration Summary [Modify] IPG [Connections]

[ ]

Stimulator (

IPG) Remote ControlBoston

Scientific Remote Control Trial Stimulator

Physician Trial Kit Remote Control

Trial Stimulator Clinician Programmer (CP) " "

Trial Stimulator A Remote Control

Trial Stimulator B IPGTrial Stimulator A

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Remote Control Remote Control

Stimulator P

Stimulator

Stimulator

Remote Control

Stimulator

Remote Control P 3

Enter Clinician Options

Enter Clinician Options "To Clear Link"

Remote Control

Remote Control Remote Control [ - ABC]

[Reset]

[Change Patient]

Remote Control IPG[Change Link]

Clinician Programmer (CP) IR /USB USB

Remote Control Remote Control IR IR

Remote Control [ ] "CP Ready"

System

Remote Control language

Stimulator

[System] " "

[OK]

[Cancel]

Stimulator Remote Control

[System]

[Backup Data/Logs]

[Add Lead] Stimulator Remote Control

[System Info] [EGL Scan]

[ ]

"CLINIC"

Backup Data/Logs

[OK]

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4

Bionic NAVIGATOR™ NMT-003 13 / 24

[Add Lead]

Boston Scientific

[OK] [Cancel]

[Import]

Stimulator Clinician Programmer (CP)

[System Info] Stimulator Remote Control

[OK]

EGL Scan™ EGL Scan

[EGL Scan] EGL Scan Stimulator

EGL Scan External Trial Stimulator (ETS)

EGL Scan EGL Scan

[Print] EGL Scan [Cancel]

[ ]

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5

Manual Programming

Manual

" "

[Manual] [Next] Remote Control

4

1 1

[SEL]

[ ]

[Electrodes]

(+) (-) ( )

[ /

]

130 Hz

3

1 Global

Global

Global

[ ]

[ ]

X Reports VAS System

1

Navigator

3

Navigator 4

"Navigator"

[Navigator] [Next] Navigator

[Finish]

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5

Bionic NAVIGATOR™ NMT-003 15 / 24

( ) ( ) " " " "

[ ] [Min]

[ ] [Max]

"Next"

[Next] Navigator

Navigator

Bionic Navigator™ Controller NavigatorNavigator

[ ]

3

1 [ ]

11

[ ]

[ ] [ ] 2Remote Control

1

E [Next] Coverage Area

Coverage Area

[ ]

[ ]

[Add Another Area] Navigator Navigator

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() [ ]

[ ] [X] [Redo]

Redo navigator

[Next] Remote ControlStimulator/Remote Control

Manual Navigator ( )

1 1 Coverage Area

Calibration 1 1

2

1

OR

OR Mapping

OR (E-Troll)

Boston Scientific SC-2108-xx

"OR "

[OR Mapping] [Finish]

E-Troll E-Troll

E-Troll

[E-Troll] [ ] [ ]

[ ]

3

1

E-Troll

[Electrodes] (+) 1 (-) 2 (0) 3

[ ]

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5

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X

X

Patient Options

Remote Control

Remote Control Remote Control/Stimulator

" " [Remote] [Patient Options]

[OK]

[OK] Remote Control ( "Remote Control" "

" ) 1

: [OK] 1

[Cancel]

"Cycle"

"Ramp Up"

1 (1) (2)

(3) Bionic Navigator™ (4) OR 4

mA mA mA

Remote Control/Stimulator

Remote Control

Remote Control

[Battery Use] [Program Use] / [Charge Profile]

[Retrieve] () (

)

System

Program Database

" " [Remote]

[Program Database] [Remote] [Back] "Remote

Control" [Finish] "Start "

[Preview]

[End Preview] [End Preview]

[ ] [Preview]

[End Preview]

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Bionic NAVIGATOR™ NMT-003 18 / 24

Activate

[ ] [Activate] [Activate (Stim off)]

[Activate (Stim off)]

[Manual] Remote Control [Re-NAV] Navigator /

"Remote"

Manual

[ ] [Delete]

[Manual]

[VAS]

Remote Control

Remote Control Remote Control

Remote Control

"Remote Control"

[Remote] "Remote Control" "Start " [Finish]

[Back]

( ) Remote Control

4 1

[ ] [Save To]

Remote Control 4

[Save To] [3]

Activate Remote Control

( )

[ ] [Activate] [Activate (Stim off)]

[Activate (Stim off)]

[Manual] Remote Control

[Re-NAV] Navigator /Remote Control

Remote Control

Remote Control[Preview]

[End Preview] [End Preview]

Remote Control

Remote Control [ ] [Preview]

[End Preview]

Re-NAV [Re-NAV]

(Navigator ) Navigator " " Coverage Area

[ ]

[ ] [Delete] Remote Control

[Delete] ( "

" ) 2 : [Delete]

2

[Program Database]

[Manual] [Battery] [Patient Options] [VAS]

2 (1) (2) (3)

Bionic Navigator™ (4) OR 4

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(Stim)

[Stop]

[Turn on]

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6

Report

" "

[Reports] [Finish]

[ ]

VAS

() /

[Qualifiers] [Create a Report] print export

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7

Bionic NAVIGATOR™ NMT-003 21 / 24

7

Impedance

IPG 164,500

X

(Config) OR [ ] [Measure] [Close]

X

OR

OR Mapping

OR (E-Troll)

Boston Scientific SC-2108-xx

"OR "

[OR Mapping] [Finish]

E-Troll E-Troll

E-Troll

[E-Troll] [ ] [ ]

[ ]

3

1

E-Troll

[Electrodes] (+) 1 (-) 2 (0) 3

[ ]

X

X

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Contacting Boston Scientific

AUS Australian Sponsor Address Boston Scientific (Australia) Pty Ltd

PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666

EC REP EU Authorised Representative Boston Scientific International S.A.

55 Avenue des Champs Pierreux TSA 51101 92729 NANTERRE CEDEX FRANCET: +33 1 57 66 80 00 F: +33 1 57 66 84 99European Headquarters – ParisT: +33 1 57 66 80 00 F: +33 1 57 66 84 99ArgentinaT: +5411 4896 8556 F: +5411 4896 8550Australia / New ZealandT: 1800 676 133 F: 1800 836 666AustriaT: +43 1 60 810 F: +43 1 60 810 60BalkansT: 0030 210 95 37 890 F: 0030 210 95 79 836BelgiumT: 080094 494 F: 080093 343BrazilT: +55 11 5853 2244 F: +55 11 5853 2663BulgariaT: +359 2 986 50 48 F: +359 2 986 57 09CanadaT: +1 888 359 9691 F: +1 888 575 7396ChileT: +562 445 4904 F: +562 445 4915China – BeijingT: +86 10 8525 1588 F: +86 10 8525 1566China – GuangzhouT: +86 20 8767 9791 F: +86 20 8767 9789China – ShanghaiT: +86 21 6391 5600 F: +86 21 6391 5100ColombiaT: +57 1 629 5045 F: +57 1 629 5082Czech RepublicT: +420 2 3536 2911 F: +420 2 3536 4334DenmarkT: 80 30 80 02 F: 80 30 80 05FinlandT: 020 762 88 82 F: 020 762 88 83FranceT: +33 1 39 30 49 00 F: +33 1 39 30 49 01GermanyT: 0800 072 3301 F: 0800 072 3319GreeceT: +30 210 95 42401 F: +30 210 95 42420Hong KongT: +852 2960 7100 F: +852 2563 5276

HungaryT: +36 1 456 30 40 F: +36 1 456 30 41India – BangaloreT: +91 80 5112 1104/5 F: +91 80 5112 1106India – ChennaiT: +91 44 2648 0318 F: +91 44 2641 4695India – DelhiT: +91 11 2618 0445/6 F: +91 11 2618 1024India – MumbaiT: +91 22 5677 8844 F: +91 22 2617 2783ItalyT: +39 010 60 60 1 F: +39 010 60 60 200KoreaT: +82 2 3476 2121 F: +82 2 3476 1776MalaysiaT: +60 3 7957 4266 F: +60 3 7957 4866MexicoT: +52 55 5687 63 90 F: +52 55 5687 62 28Middle East / Gulf / North AfricaT: +961 1 805 282 F: +961 1 805 445The NetherlandsT:+31 30 602 5555 F: +31 30 602 5560NorwayT: 800 104 04 F: 800 101 90PhilippinesT: +63 2 687 3239 F: +63 2 687 3047PolandT: +48 22 435 1414 F: +48 22 435 1410PortugalT: +351 21 3801243 F: +351 21 3801240SingaporeT: +65 6418 8888 F: +65 6418 8899South AfricaT: +27 11 840 8600 F: +27 11 463 6077SpainT +34 901 11 12 15 F +34 902 26 78 66SwedenT: 020 65 25 30 F: 020 55 25 35SwitzerlandT: 0800 826 786 F: 0800 826 787TaiwanT: +886 2 2747 7278 F: +886 2 2747 7270ThailandT: +66 2 2654 3810 F: +66 2 2654 3818Turkey – IstanbulT: +90 216 464 3666 F: +90 216 464 3677United StatesT: +1 661 949 4747 Toll Free: +1 866 360 4747F: +1 661 949 4022UruguayT: +59 82 900 6212 F: +59 82 900 6212UK & EireT: +44 844 800 4512 F: +44 844 800 4513VenezuelaT: +58 212 959 8106 F: +58 212 959 5328

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NOTE: Phone numbers and fax numbers may change. For the most current contact information, please refer to our website at http://www.bostonscientific-international.com/ or write to the following address:Boston Scientific Neuromodulation25155 Rye Canyon LoopValencia, CA 91355 USA

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NMT-003

Bionic Navigator

24 6 11 1

22200BZX00761000

SCS