NMT-003 90851363-01A Bionic NAVIGATOR SC-7150SC-7150-4NM-7152-12 Clinician Programmer (CP) Bionic NAVIGATOR 2 2011 Boston Scientific Corporation or its affiliates. All Rights Reserved. 1957 3 11 Boston Scientific Corporation
Bionic NAVIGATOR Bionic NAVIGATOR SC-7150SC-7150-4NM-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 Bionic NAVIGATOR NMT-003 2 / 24
1 Clinician Programmer (CP) 1 Clinician Programmer (CP) Clinician Programmer (CP) Remote Control Stimulator CP Remote Control CP PC 3 PC Windows [Windows ] [] [X] CP [] Bionic Navigator 1. SEL 1 SEL 2 Remote Control [] 2. [- ABC] CP CP PC PC [ ] (< ) www.toshiba.com Portege 3500M200M400 M750 PC 3. P Remote Control [] 4. "CP Mode" Remote Control [CP Ready] Remote Control IR IR Stimulator Remote Control 60cm (2 ) Clinician Programmer (CP) IR Remote Control IR Bionic NAVIGATOR NMT-003 3 / 24
Bionic NAVIGATOR Bionic Navigator Controller [OFF] "Mark" Clinician Programmer (CP) system Remote Control language Stimulator [System] "" [OK] [Cancel] (PC) PC "" [Sync Data] PC "" Clinician Programmer (CP) PCMCIA [START] / [Sync Data] [Select All] [] [delete] Stimulator Remote Control [System] [Backup Data/Logs] [Add Lead] Stimulator Remote Control [System Info] [EGL Scan] [] - "CLINIC" Backup Data/Logs - [OK] Boston Scientific " " Bionic NAVIGATOR NMT-003 4 / 24
1 Clinician Programmer (CP) EGL Scan [Add Lead] - Boston Scientific [OK] [Cancel] [Import] EGL Scan [EGL Scan] - EGL Scan Stimulator - EGL Scan External Trial Stimulator (ETS) EGL Scan EGL Scan [Print] EGL Scan [Cancel] [] Stimulator Clinician Programmer (CP) [System Info] Stimulator Remote Control [OK] Bionic NAVIGATOR NMT-003 5 / 24
Bionic NAVIGATOR 2 VAS OR Patient Profile " " [Profile] [Manual] Navigator [Finish] [Next] [Profile] () Patient Profile [] [Manual] Navigator "Coverage Area" " " 1 [] (RES) () [RES] [VIEW] OR Mapping OR (E-Troll) Boston Scientific SC-2108-xx "OR " [OR Mapping] [Finish] E-Troll E-Troll E-Troll [E-Troll] [] [] [] 3 1 Remote Control VAS Bionic NAVIGATOR NMT-003 6 / 24
2 VAS E-Troll [Electrodes] - (+) 1 - (-) 2 - (0) 3 [] X X VAS VAS "" "" "" "" Bionic Navigator VAS () () VAS Profile ManualNavigator Remote VAS VAS [OK] [Cancel] [] [] [] 0 10 VAS VAS VAS Reports VAS Bionic NAVIGATOR NMT-003 7 / 24
Bionic NAVIGATOR 3 "" [Profile][Case History] [OK] Reports Profile "" Start [Reason for Visit] OR Mapping Manual Navigator Remote Control Remote Reports Start Start Bionic Navigator Help Config Profile Sync Data Notes Start OR Navigator 3 () () "" Profile[Notes] - CP PC [OK] [Cancel] Profile Case History Reports Bionic Navigator [Start] "Start " [] Bionic Navigator [Patient Name] [New Patient] Bionic NAVIGATOR NMT-003 8 / 24
3 Profile VAS "" [Profile] Start [patient name] [new patient] Profile Start 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 Bionic NAVIGATOR NMT-003 9 / 24
Bionic NAVIGATOR 4 "" [Config] Hardware Configuration Summary Start [Finish] [Modify] Battery Status Stimulator () " " [Remote] [Battery] Remote Control [OK] Stimulator [Measure] 5 25 Remote Control 24 Stimulator Reports -Stimulator "" Stimulator 1-L 2-R Stimulator [Connections] [SWAP] Stimulator [OK] Connections [OK] [Cancel] Hardware Configuration Summary Stimulator Remote Control ( ) Bionic NAVIGATOR NMT-003 10 / 24
4 () 3 Navigator "" [Config] Hardware Configuration Summary Modify [Finish] Lead Model Lead Orientation [Retrograde] [Vertebral Control] [Next] [Finish] Start Hardware Configuration Summary Hardware Configuration Summary [Modify] IPG [Connections] [] [] 2 [Next] 2 Lead Configuration 1 Lead Orientation Lead Configuration [] [Next] Stimulator ( IPG) Remote Control Boston Scientific Remote Control Trial Stimulator Physician Trial Kit Remote Control Trial Stimulator Clinician Programmer (CP) "" Trial Stimulator A Remote Control Trial Stimulator B IPG Trial Stimulator A Bionic NAVIGATOR NMT-003 11 / 24
Bionic NAVIGATOR 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] Bionic NAVIGATOR NMT-003 12 / 24
4 [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] [] Bionic NAVIGATOR NMT-003 13 / 24
Bionic NAVIGATOR 5 [ ] X Reports VAS System 1 Manual Programming Manual "" [Manual] [Next] Remote Control 4 1 1 [SEL] [] [Electrodes] (+) (-) () [/ ] 130 Hz 3 1 Global Global Global [] Navigator 3 Navigator 4 "Navigator" [Navigator] [Next] Navigator [Finish] Bionic NAVIGATOR NMT-003 14 / 24
5 () () "" "" [] [Min] [] [Max] "Next" [Next] Navigator 3 1 [] 1 1 [] [] [] 2 Remote Control 1 E [Next] Coverage Area Coverage Area Navigator Bionic Navigator Controller Navigator Navigator [] [] [ ] [Add Another Area] Navigator Navigator Bionic NAVIGATOR NMT-003 15 / 24
Bionic NAVIGATOR ( ) [] [] [X] [Redo] Redo navigator [Next] Remote Control Stimulator/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 [] Bionic NAVIGATOR NMT-003 16 / 24
5 X X ma ma ma Remote Control/Stimulator Remote Control Remote Control [Battery Use][Program Use] / [Charge Profile] [Retrieve] ( ) ( ) Patient Options Remote Control Remote Control Remote Control/Stimulator System "" [Remote][Patient Options] [OK] [OK] Remote Control ( "Remote Control" " " ) 1 : [OK] 1 [Cancel] "Cycle" "Ramp Up" Program Database " " [Remote] [Program Database] [Remote] [Back] "Remote Control" [Finish] "Start " [Preview] [End Preview] [End Preview] 1 (1) (2) (3) Bionic Navigator (4) OR 4 [] [Preview] [End Preview] Bionic NAVIGATOR NMT-003 17 / 24
Bionic NAVIGATOR Activate [] [Activate] [Activate (Stim off)] [Activate (Stim off)] [Manual] Remote Control [Re-NAV] Navigator / "Remote " Manual [] [Delete] [Manual] [VAS] Remote Control 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 [] 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] [ ] [Delete] Remote Control [Delete] ( " " ) 2 : [Delete] 2 [Program Database] [Manual] [Battery] [Patient Options] [VAS] 2 (1) (2) (3) Bionic Navigator (4) OR 4 Bionic NAVIGATOR NMT-003 18 / 24
5 (Stim) [Stop] [Turn on] Bionic NAVIGATOR NMT-003 19 / 24
Bionic NAVIGATOR 6 Report "" [Reports] [Finish] [ ] VAS ( )/ [Qualifiers] [Create a Report] print export Bionic NAVIGATOR NMT-003 20 / 24
7 7 E-Troll E-Troll E-Troll Impedance IPG 16 4,500 X [E-Troll] [] [] [] 3 1 (Config) OR [] [Measure] [Close] X OR E-Troll [Electrodes] (+) 1 (-) 2 (0) 3 [] X X OR Mapping OR (E-Troll) Boston Scientific SC-2108-xx "OR " [OR Mapping] [Finish] Bionic NAVIGATOR NMT-003 21 / 24
Contacting Boston Scientific Australian Sponsor Address AUS Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 EU Authorised Representative EC REP Boston Scientific International S.A. 55 Avenue des Champs Pierreux TSA 51101 92729 NANTERRE CEDEX FRANCE T: +33 1 57 66 80 00 F: +33 1 57 66 84 99 European Headquarters Paris T: +33 1 57 66 80 00 F: +33 1 57 66 84 99 Argentina T: +5411 4896 8556 F: +5411 4896 8550 Australia / New Zealand T: 1800 676 133 F: 1800 836 666 Austria T: +43 1 60 810 F: +43 1 60 810 60 Balkans T: 0030 210 95 37 890 F: 0030 210 95 79 836 Belgium T: 080094 494 F: 080093 343 Brazil T: +55 11 5853 2244 F: +55 11 5853 2663 Bulgaria T: +359 2 986 50 48 F: +359 2 986 57 09 Canada T: +1 888 359 9691 F: +1 888 575 7396 Chile T: +562 445 4904 F: +562 445 4915 China Beijing T: +86 10 8525 1588 F: +86 10 8525 1566 China Guangzhou T: +86 20 8767 9791 F: +86 20 8767 9789 China Shanghai T: +86 21 6391 5600 F: +86 21 6391 5100 Colombia T: +57 1 629 5045 F: +57 1 629 5082 Czech Republic T: +420 2 3536 2911 F: +420 2 3536 4334 Denmark T: 80 30 80 02 F: 80 30 80 05 Finland T: 020 762 88 82 F: 020 762 88 83 France T: +33 1 39 30 49 00 F: +33 1 39 30 49 01 Germany T: 0800 072 3301 F: 0800 072 3319 Greece T: +30 210 95 42401 F: +30 210 95 42420 Hong Kong T: +852 2960 7100 F: +852 2563 5276 Hungary T: +36 1 456 30 40 F: +36 1 456 30 41 India Bangalore T: +91 80 5112 1104/5 F: +91 80 5112 1106 India Chennai T: +91 44 2648 0318 F: +91 44 2641 4695 India Delhi T: +91 11 2618 0445/6 F: +91 11 2618 1024 India Mumbai T: +91 22 5677 8844 F: +91 22 2617 2783 Italy T: +39 010 60 60 1 F: +39 010 60 60 200 Korea T: +82 2 3476 2121 F: +82 2 3476 1776 Malaysia T: +60 3 7957 4266 F: +60 3 7957 4866 Mexico T: +52 55 5687 63 90 F: +52 55 5687 62 28 Middle East / Gulf / North Africa T: +961 1 805 282 F: +961 1 805 445 The Netherlands T:+31 30 602 5555 F: +31 30 602 5560 Norway T: 800 104 04 F: 800 101 90 Philippines T: +63 2 687 3239 F: +63 2 687 3047 Poland T: +48 22 435 1414 F: +48 22 435 1410 Portugal T: +351 21 3801243 F: +351 21 3801240 Singapore T: +65 6418 8888 F: +65 6418 8899 South Africa T: +27 11 840 8600 F: +27 11 463 6077 Spain T +34 901 11 12 15 F +34 902 26 78 66 Sweden T: 020 65 25 30 F: 020 55 25 35 Switzerland T: 0800 826 786 F: 0800 826 787 Taiwan T: +886 2 2747 7278 F: +886 2 2747 7270 Thailand T: +66 2 2654 3810 F: +66 2 2654 3818 Turkey Istanbul T: +90 216 464 3666 F: +90 216 464 3677 United States T: +1 661 949 4747 Toll Free: +1 866 360 4747 F: +1 661 949 4022 Uruguay T: +59 82 900 6212 F: +59 82 900 6212 UK & Eire T: +44 844 800 4512 F: +44 844 800 4513 Venezuela T: +58 212 959 8106 F: +58 212 959 5328 Bionic NAVIGATOR NMT-003 22 / 24
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 Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355 USA Bionic NAVIGATOR NMT-003 23 / 24
NMT-003 Bionic Navigator 24 6 11 1 22200BZX00761000 SCS