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Precision™ Spinal Cord Stimulator System Clinician Manual
SC-1110 Precision Implantable Pulse Generator SC-2158-xx Linear™ xxcm 8 Contact Lead SC-2158-xxE Linear xxcm 8 Contact Lead SC-2218-xx Linear ST™ xxcm 8 Contact Lead SC-2218-xxE Linear ST xxcm 8 Contact Lead SC-2352-xx Linear 3-4 xxcm 8 Contact Lead SC-2352-xxE Linear 3-4 xxcm 8 Contact Lead SC-2366-xx Linear 3-6 xxcm 8 Contact Lead SC-2366-xxE Linear 3-6 xxcm 8 Contact Lead SC-3138-xx xxcm 8 Contact Extension SC-3304-xx D4 Splitter 2x4 SC-3354-xx W4 Splitter 2x4 SC-5210 or SC-5212 Precision Remote Control SC-5305 Precision Base Station SC-5312 Precision Charger SC-8216-xx Artisan 2x8 Surgical Lead
: xx = (cm) xxE = (cm) Trial Lead
NMT-001
90851362-01A
Precision™ Spinal Cord Stimulator System Clinician Manual
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Clinician Manual NMT-001 3 / 68
SC-1110 Precision Implantable Pulse Generator SC-2158-xx Linear™ xxcm 8 Contact Lead SC-2158-xxE Linear xxcm 8 Contact Lead SC-2218-xx Linear ST™ xxcm 8 Contact Lead SC-2218-xxE Linear ST xxcm 8 Contact Lead SC-2352-xx Linear 3-4 xxcm 8 Contact Lead SC-2352-xxE Linear 3-4 xxcm 8 Contact Lead SC-2366-xx Linear 3-6 xxcm 8 Contact Lead SC-2366-xxE Linear 3-6 xxcm 8 Contact Lead SC-3138-xx xxcm 8 Contact Extension SC-3304-xx D4 Splitter 2x4 SC-3354-xx W4 Splitter 2x4 SC-5210 or SC-5212 Precision Remote Control SC-5305 Precision Base Station SC-5312 Precision Charger SC-8216-xx Artisan 2x8 Surgical Lead
: xx = (cm) xxE = (cm) Trial Lead
............................................................................................... 7 ............................................................................................................ 8
Implantable Pulse Generator .................................................................................................... 8 Lead ......................................................................................................................................... 8 Lead Extension ......................................................................................................................... 9 Lead Splitter ............................................................................................................................. 9
.......................................................................................................... 10 ....................................................................................................................................... 10
.......................................................................................................... 11 ...................................................................................................... 11
........................................................................................................................................ 11 .............................................................................................................................. 12 .............................................................................................................................. 13
............................................................................................................ 14
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............................................................................................. 15 IPG Kit .................................................................................................................................... 15 Percutaneous Permanent Lead Kit ......................................................................................... 15 Percutaneous Trial Lead Kit ................................................................................................... 15 Lead Extension Kit ................................................................................................................. 15 Lead Splitter Kit ...................................................................................................................... 15 Surgical Paddle Lead Kit ........................................................................................................ 15
.............................................................................. 16 ....................................................................................................................................... 16
IPG ....................................................................................................... 16 Lead Lead Extension Splitter ............................................... 17
................................................................................................... 18 Percutaneous Lead .................................................... 19 Surgical Paddle Lead .................................................. 21
Splitter Lead ................................................................................................... 21 OR Cable Assembly ........................................................................... 23
.......................................................................................... 24 Trial Lead ............................................................................................ 26
Lead ....................................................................... 27 Lead ......................................................................................................................... 27 Lead Lead Extension ..................................................................... 28 Lead Extension ........................................................................................................ 29
Trial Stimulator ............................................................................... 31 Trial Lead Lead Extension Splitter ........................................... 32
A: Percutaneous Lead ................................... 32 B: Lead Extension ...................................... 32 C: Splitter ................................................................. 32
IPG ................................................................................................... 33 IPG ................................................................................................... 34
Percutaneous Lead Dual Lead .............................................................. 34 Percutaneous Lead Single Lead ........................................................... 34 Surgical Paddle Lead ............................................................................................... 34
Clinician Manual NMT-001 5 / 68
IPG ................................................................................ 36 ............................................................................... 37
IPG ............................................................................................... 37 ......................................................................................................................... 38 Remote Control ................................................................................................ 40
................................................................................................................ 44 ....................................................................................................................................... 45
............................................................................................................ 46 ...................................................................................... 51
....................................................................................................................................... 51 1 ....................................................... 52
.......................................................................................................... 55 Stimulator Lead ................................................................................................... 55
......................................................................................... 55 ....................................................................................................... 56
................................................................................................................. 59
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© 2011 Boston Scientific Corporation or its affiliates. All rights reserved.
Boston Scientific Corporation Boston Scientific Corporation
Boston Scientific Corporation
BionicNavigator™ Precision™ Boston Scientific Corporation
Clinician Manual NMT-001 7 / 68
Boston Scientific Precision
Spinal Cord Stimulator (SCS)
Boston ScientificPercutaneous Lead Lead Extension SplitterSurgical Paddle Lead Implantable Pulse Generator (IPG)
IPG
BionicNavigator
Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual NMT-001 8 / 68
Precision Implantable Pulse GeneratorLead Surgical Paddle Lead Lead Extension
Precision SCS
16 4
1 4
60 cm (2 )
Implantable Pulse Generator Precision Implantable Pulse Generator (IPG)
IPG
IPGRemote ControlBionicNavigator
IPG Patient Charging KitRF Charger
Lead Percutaneous Lead Surgical Paddle Lead
Precision SCS
Surgical Paddle Lead 2x8 Surgical Paddle Lead 50 cm 70 cm
Lead () 8 2
3 2 mm2 2Lead
Percutaneous Lead8
Paddle Lead
IPG Lead Extension
Percutaneous Lead Percutaneous Lead 30 cm 50 cm
70 cm Lead8
3 mm1 4 6 mm
Curved StyletLead Lead
Lead Extension SplitterIPG
Clinician Manual NMT-001 9 / 68
Percutaneous Lead Trial Lead Kit Linear™ Lead
Lead Extension Lead Extension Percutaneous LeadPaddle Lead Precision IPG
LeadIPG Lead
Lead Extension Lead
Lead Extension 25 cm 35 cm55 cm Lead Extension
8
3 mm1 mm Lead Extension
Trial Stimulator (Lead KitOR Cable Assembly )
Precision IPG
Lead Splitter Lead Splitter LinearLinear ST™ Lead Precision IPG
Linear Lead SplitterIPG 1
4 Linear LeadLinear Lead 8
4 SplitterDistal 4 (D4) Wide 4
(W4) 2 2
Precision™ Spinal Cord Stimulator System Clinician Manual
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Precision Spinal Cord Stimulator (Precision )
SCS
SCS
Clinician Manual NMT-001 11 / 68
Charger
Charging BeltCharger
(MRI) Precision SCSMRI
MRI
Lead Stimulator "
"
/
SCS
Lead
IPG
Stimulator
IPG
IPG
Stimulator
Stimulator
Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual NMT-001 12 / 68
/
Stimulator
:
14
14
/
2
2 kg (5 )
Lead
2
Stimulator Stimulator" "
StimulatorStimulator
Stimulator
Lead Lead
StimulatorLead
Clinician Manual NMT-001 13 / 68
LeadStimulator
( 4 )
Stimulator
Remote Control Charging System
35 °C (95 °F) Charger
Remote Control Charging System
–20 60 °C (-4 140 °F)
Remote ControlCharger
IPG
Boston Scientific
Remote Control Charging System
Lead
Lead
IPG
Precision™ Spinal Cord Stimulator System Clinician Manual
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(CSF)
MRI
Lead Lead
Lead
Stimulator
IPG Lead
Remote Control
/
5
IPG
IPG
IPG
IPG
Clinician Manual NMT-001 15 / 68
IPG Kit (1) Precision Implantable Pulse Generator (1) Hex Wrench (1) Tunneling Tool Assembly (1) IPG Pocket Template (2) Port Plugs (1) (1) ID (1)
Percutaneous Permanent Lead Kit (1) Pre-loaded Curved Stylet
Percutaneous Lead (1) Curved Straight Stylet
Stylet Ring (4) Suture Sleeves (1) Stylet Insertion Needle (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labels—
( ) (1) (1) ID (1)
Percutaneous Trial Lead Kit (1) Pre-loaded Curved Stylet
Percutaneous Lead (1) Suture Sleeves (1) Stylet Insertion Needle (1) Steering Cap (1) OR Cable Assembly
(2) Lead Position Labels— ( )
(1) (1) (1) ID
Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) (1) ID (1)
Lead Splitter Kit (1) Splitter (1) Hex Wrench (1) (1) ID (1)
Surgical Paddle Lead Kit (1) Paddle Lead (4) Suture Sleeves (2) OR Cable Assembly (2) Lead Position Labels—
( ) (1) (1) ID (1)
Precision™ Spinal Cord Stimulator System Clinician Manual
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Precision
Boston Scientific
" "
1
: (EO)
Boston Scientific
1
1
Lead
/
IPG IPG
IPG 30 cm (1 )
IPG IPG
IPGBoston Scientific
IPG 0 °C 45 °C (32 °F 113 °F)
Clinician Manual NMT-001 17 / 68
IPG
Lead Lead ExtensionSplitter
Lead
Lead Lead Extension Splitter
Lead Lead Extension Splitter
Suture Sleeve Percutaneous Lead Lead
BlankLead
Lead
Lead
Lead
Lead
Lead connector
Lead stylet Lead Lead stylet
0 °C 45 °C (32 °F
113 °F)
Precision™ Spinal Cord Stimulator System Clinician Manual
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1. IPG
IPG IPGCharger
IPG
2. (16
)
3. Trial StimulatorTrial Stimulator
4. Trial Stimulator Remote Control
(44)
5. Patient Trial Kit
19 Percutaneous Lead
6. IPG32 Trial Lead Lead Extension
Splitter
Percutaneous Lead
Clinician Manual NMT-001 19 / 68
Percutaneous Lead 1.
2. XInsertion Needle 45°
: Boston ScientificInsertion Needle
Lead
"14" (Curved Epimed needle )
Lead45° Lead
: Insertion Needle 45°Stylet
Stylet Lead
3. Insertion Needle Stylet
4. : X Lead BlankInsertion Needle
Lead Blank
5. Lead stylet handle Stylet handle Steering Cap
Lead Stylet Insertion NeedleLead stylet Lead
6. : Lead styletStylet
Stylet Stylet Lead
Stylet 3 cm Lead Stylet Stylet
Stylet
Precision™ Spinal Cord Stimulator System Clinician Manual
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: Lead Insertion NeedleLead stylet
Stylet Insertion Needle Lead
Insertion NeedleLead stylet Lead
Lead
: Lead styletStylet Lead
Stylet Lead
7. XLead Lead
Lead ( 10 cm3 )
8. 23 OR Cable Assembly
Surgical Paddle Lead
Clinician Manual NMT-001 21 / 68
Surgical Paddle Lead 1. X Lead
2.
3. : Paddle LeadPassing Elevator
Passing ElevatorPaddle Lead
Passing Elevator
Passing Elevator
Passing Elevator Lead
: Passing
ElevatorPassing
Elevator
4. Paddle Lead
5. Lead
Paddle Lead23 OR Cable Assembly
Splitter Lead 1. Splitter Lead Stylet
2. Lead
3. Splitter
4. Hex WrenchSplitter
: Lead
Precision™ Spinal Cord Stimulator System Clinician Manual
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5. LeadSplitter receptacle
Lead
( ) Splitter receptacle
6. 23 OR Cable Assembly7
7.
: Splitter receptacle1 4
5 8Splitter receptacle
Lead
8. Hex Wrench
Splitter Lead
OR Cable Assembly
Clinician Manual NMT-001 23 / 68
OR Cable Assembly OR Cable Assembly Lead Trial Stimulator
: OR Cable
OR Cable Assembly 1
1. Lead 2 "1-L" "2-R" Trial StimulatorLead
2. Trial Stimulator
: Trial Stimulator
3. OR Cable "0"
4. Percutaneous Lead Stylet Steering Cap LeadStylet Splitter
OR Cable
5. Lead Splitter
Lead "1"
6. OR Cable Assembly "1-L" ( )
"2-R" ( ) Trial Stimulator
( ) Lead "1-L" ( ) Lead "2-R" Lead1 "1-L"
7. 24
Precision™ Spinal Cord Stimulator System Clinician Manual
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:
BionicNavigator
1. Splitter
Splitter Lead
Splitter
BionicNavigatorSplitter
2. Clinician Programmer (CP) Trial Stimulator
Lead IPG 16
4500
X
3. Lead
: Lead
4. LeadSplitter
SplitterLead
Lead Splitter Stylet Lead
5. Lead
6. Stylet LeadSplitter
7.
: Stylet Lead
8. Lead 1 3
9.
a) Trial Stimulator
b) OR Cable ConnectorLead
c) Percutaneous Lead Stylet
10. XLead Lead
11. Splitter LeadSplitter Hex Wrench
: Lead
Clinician Manual NMT-001 25 / 68
A: 26 Trial Lead
B: 27 Lead
C: Percutaneous LeadIPG 27
Lead
D: Paddle LeadIPG 27 Lead
SCS
Precision™ Spinal Cord Stimulator System Clinician Manual
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Trial Lead 1. Lead Insertion Needle
LeadInsertion Needle
2. Insertion Needle
LeadLead
3. Lead
4.
5. Splitter 21 Splitter Lead
Lead
Clinician Manual NMT-001 27 / 68
Lead
Insertion Needle 1. Lead
Insertion Needle
2. Lead Insertion NeedleLead
Insertion Needle
3. Insertion Needle
LeadLead
Lead 1. Percutaneous Lead X
LeadLead stylet
2. Lead Suture Sleeve
3. 2-0
Suture SleeveLead
: Suture Sleeve
LeadLead
Lead
: 4 cm 2.3 cm Suture Sleeve3
4. Suture Sleeve
5. Suture SleeveLead
: Lead Lead
6. 28Lead Lead Extension
7. IPG 33IPG
Precision™ Spinal Cord Stimulator System Clinician Manual
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Lead Lead Extension
1. Tunneling Tool
2.
3.
4. :
5.
6.
7. Tunneling Tool
Lead
Clinician Manual NMT-001 29 / 68
8. Tunneling
Tool
9. Lead Lead Extension
: Splitter
10. Trial Lead 29Lead Extension
11. IPG Lead Extension 29
Lead Extension
12. IPG Splitter21 Splitter
Lead
13. IPG 34IPG
Lead Extension 1. Lead
Lead Extension connectorSplitter
( )
: Lead Lead Extension connector
Hex Wrench (
) Lead
2. Lead Lead
3. Hex WrenchLead
Extension connector
: Hex Wrench
Hex Wrench
Precision™ Spinal Cord Stimulator System Clinician Manual
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4. Lead Lead
Extension connector
5. LeadLead
Lead
: Lead Lead
6. Lead Extension
7. Lead Extension
31 Trial Stimulator
8. 34 IPG
Trial Stimulator
Clinician Manual NMT-001 31 / 68
Trial Stimulator 1. Lead 2 "1-L"
Lead "2-R" Lead
Splitter 2"1-L"
Splitter "2-R" Splitter
2. OR Cable Trial Stimulator
Lead 1OR Cable Trial Stimulator "1-L"
3. Trial Belt
Trial Stimulator
1. OR Cable
2. OR Cable Connector
3. External Trial Stimulator (ETS)
4. Trial Belt
5. Lead Lead Extension
Precision™ Spinal Cord Stimulator System Clinician Manual
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Trial Lead Lead ExtensionSplitter
A: Percutaneous Lead 1. Trial Lead
2. Lead
3. Trial Lead Percutaneous Lead19
Percutaneous Lead
4. Trial Lead Paddle Lead21 Surgical
Paddle Lead
B: Lead Extension 1. Lead Extension
2. Lead ExtensionLead
3.
Lead Extension
4. Hex Wrench Lead Extension connector
Lead
5. 33 IPG
C: Splitter
1. SplitterLead Splitter
2. Hex Wrench Splitter receptacle
3. Splitter component
IPG
Clinician Manual NMT-001 33 / 68
IPG 1. Lead Tunneling
ToolLead Suture Sleeve
2. IPG IPG
3. IPG2.0 cm
2.0 cm
: IPG
IPG
4. IPG28 Lead Lead
Extension
Precision™ Spinal Cord Stimulator System Clinician Manual
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IPG
Percutaneous Lead – Dual Lead
( ) LeadLead Extension Splitter IPG
"1-L" ( ) Lead
Lead Extension Splitter IPG "2-R"
Percutaneous Lead – Single Lead
Single Lead Lead ExtensionSplitter IPG "1-L"
Port Plug
Surgical Paddle Lead Lead IPG "1-L"
Lead IPG "2-R"
: Paddle Lead
1. Lead Lead Extension Splitter
IPGLead Lead Extension
LeadLead
IPG
Clinician Manual NMT-001 35 / 68
: Lead Lead Extension Port Plug
Hex Wrench (
) Lead
:
2. IPGHex Wrench " "
: Lead Lead
: • Port PlugPort Plug
• Hex Wrench
3. IPG
4. Lead Lead Extension IPG
5. IPG IPG
6.
Precision™ Spinal Cord Stimulator System Clinician Manual
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IPG 1. IPG
2. IPG
3. LeadLead Extension Splitter
4. 34 IPGIPG
Lead
5. Boston ScientificIPG
Clinician Manual NMT-001 37 / 68
Precision Stimulator
1 1
Boston Scientific
Bionic Navigator1 24
10 4
ChargerRemote Control 3
Stimulator5 Stimulator
Stimulator
Stimulator
IPG StimulatorRemote Control Stimulator
Remote Control ("Recharge Stimulator Soon"
) Stimulator
Precision™ Spinal Cord Stimulator System Clinician Manual
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24"Recharge Stimulator Now"
Remote ControlStimulator
Stimulator Remote Control
:
Charger
Charging BeltCharger
Boston Scientific
ChargerBase Station Charger
Charger
Stimulator
1. Base Station Charger
2. Charger
Stimulator
3. Charger StimulatorCharger Stimulator
Charger Stimulator
StimulatorCharger Stimulator
(Charger
) Charger
Charger
Clinician Manual NMT-001 39 / 68
4. Charging BeltCharger Stimulator
:
Charger
StimulatorCharger Stimulator
( )
Charger : Charger Charging Belt
Charging BeltCharger
Stimulator ()
: Charging Belt
Charger
Charger
5. Stimulator2 ChargerCharger Charging Belt
ChargerBase Station
( 2 ) ChargerStimulator
: • 10
4 1 4
4
• 2
• Remote Control IPG
Precision™ Spinal Cord Stimulator System Clinician Manual
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Remote Control
Remote Control (RF)
60 cm (2 ) Stimulator
Remote Control ()
Remote Control"Release P To Unlock" P
1. 4.
2. / 5. /
3. /
/ /
Remote ControlStimulator
Clinician Manual NMT-001 41 / 68
Remote ControlStimulator
Remote Control StimulatorRemote Control
1 2
Remote Control Stimulator
3 4Stimulator
Remote Control "Searching"
StimulatorRemote Control
( ) Remote ControlStimulator
:
: Remote ControlStimulator
Remote Control
Remote Control " "
Precision™ Spinal Cord Stimulator System Clinician Manual
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Stimulator Stimulator
Stimulator 3
Stimulator " "
Remote Control "Recharge Battery Soon" Stimulator
Zero Volt™
Stimulator
:
( _ )
[ ]
1. P1
2. P
4 P
1
3.
(44 )
1. P 1
P
:
(__)
Clinician Manual NMT-001 43 / 68
2.
3. P
1. P 31
2. P
3.
4
( )
1.
2. ( )
Precision™ Spinal Cord Stimulator System Clinician Manual
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Remote Control
BionicNavigator
(BionicNavigator)
1. Remote Control 3
"Width"
2. 1
3.
4.
3
"Rate" 5. 1
6.
7.
3
Remote Control 1Stimulator 1
Remote Control Stimulator
1. P Remote ControlRemote Control
Stimulator
2. StimulatorRemote Control "Link?"
PRemote Control
Stimulator
Clinician Manual NMT-001 45 / 68
Stimulator Remote Control
Stimulator
(46)
3. Remote ControlStimulator
4. P
Trial Stimulator Remote ControlTrial Stimulator
Trial Stimulator
Remote Control
Remote Control IPG IPG
IPGRemote Control
Remote Control
Remote Control
Stimulator " " Remote Control StimulatorRemote ControlStimulator
Precision™ Spinal Cord Stimulator System Clinician Manual
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Remote Control Stimulator
P
Remote Control
Clinician Programmer (CP) Remote Control Stimulator
1. P 3
2.
3.
1 – CP 1. "CP
Mode" P
Remote Control Clinician Programmer (CP) CP Mode Remote Control"CP Ready"
2. Remote Control IR
IR Holder
3. IR USB CP
Clinician Manual NMT-001 47 / 68
4. BionicNavigator"Communication Established"
: •
Remote Control 15 CP Ready
• CP Ready
Remote Control
• CP Ready
• Remote Control
Clinician Programmer (CP) External Trial Stimulator IPG
Stimulator
Remote Control 60 cm (2 ) Clinician Programmer (CP) BionicNavigator
IPGRemote Control
BionicNavigator
2 –
"Impedances" Remote Control Lead
10
Precision™ Spinal Cord Stimulator System Clinician Manual
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: Stimulator
Remote Control
1 8 ("1-L" Lead )
19 16 ("2-R" Lead )
9
(4500 )
( / )
1 8
9 16
Clinician Manual NMT-001 49 / 68
"Measure Again?"
P
3 – "Clear
Link" Stimulator
P
Precision™ Spinal Cord Stimulator System Clinician Manual
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Enter Password
P /
Remote Control StimulatorRemote Control "Link?"
Remote Control
Remote Control
4 –
"Language" 7
P
P
Remote Control
Clinician Manual NMT-001 51 / 68
( ) 4 —
0 20 mAa 0 mA
2 1200 ppsb 40 pps
0 – 1000 sec 210 sec
0 90 min
1 10 sec 3 sec
1 16: + - 1 – 16: a. Precision 12.7 mA
20 mA12.7 mA
7.3 mA b. 130 pps 1
/ 55 mm x 45 mm x 11 mm / 20.7 cm3 ( )
Precision™ Spinal Cord Stimulator System Clinician Manual
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1
Clinician Manual NMT-001 53 / 68
Linear™ Lead
Lead 30 50 70 cm
Lead
Lead 1.3 mm
8
3 mm
1 4 6 mm
/
MP35N-DFT- 28%
Lead Extension
Lead Extension 25 35 55 cm
Lead Extension 1.3 mm
8
/ MP35N
MP35N-DFT- 28%
Precision™ Spinal Cord Stimulator System Clinician Manual
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Lead Splitter
Splitter 25 cm
Splitter 1.3 mm ( )
8 (1 4)
/ MP35N
MP35N-DFT- 28%
Surgical Lead
Lead 50 70 cm
Lead 2 x 8
Lead 8 mm
16
3 mm
1 mm
/
MP35N-DFT- 28%
Clinician Manual NMT-001 55 / 68
Stimulator Lead
Boston ScientificLead/Lead Extension/Splitter
Lead
1Boston Scientific1 1
1
Precision™ Spinal Cord Stimulator System Clinician Manual
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Precision
2005 CE
Clinician Manual NMT-001 57 / 68
1
: BF
WEEE
Precision™ Spinal Cord Stimulator System Clinician Manual
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EN 60601-1
II
201 – – – (6.8.3.201 a ) 3))
– IPG IPG
RF CISPR 11 1 IPG RFRF
RF CISPR 11 B
IEC 61000-3-2
IPG
/
IEC 61000-3-3
Boston Scientific Precision 1999/5/EC
Clinician Manual NMT-001 59 / 68
Stimulator Stimulator
5Stimulator 25
(40 ) 1 (40 ) 1
Boston Scientific
a) :
b) : 50%
2750
/10.2
: 6 mA
: 240 Hz
: 400 μsec
: 750
750 500 11.3
1000 9.7
Precision™ Spinal Cord Stimulator System Clinician Manual
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1. Precision
2. 1
()
Precision
Stimulator
: • "*" Precision
"*"
•
Boston Scientific
Clinician Manual NMT-001 61 / 68
1.
= 1____+ 2____+ 3____+ 4 ____ = _____Hz
2. 1
(RWPW)
RWPW1 = PW1 x 1/ = _______ RWPW2 = PW2 x 2/ = _______ RWPW3 = PW3 x 3/ = _______ RWPW4 = PW4 x 4/ = _______
3. 2 (TWPW)
TWPW = RWPW1____+ RWPW2____+ RWPW3____+ RWPW4____ TWPW = _________ μsec
4.
= __________ mA
5. TWPW ( )
StimulatorStimulator
1 2
1: = 5.0 mA = 30 Hz PW = 200 μsec
2: = 8.0 mA = 60 Hz PW = 400 μsec
1. (TR)
= 1 30 Hz + 2 60 Hz = 90 Hz
Precision™ Spinal Cord Stimulator System Clinician Manual
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2. (RWPW)
RWPW1 = PW1 x 1/ = (30 x 200)/90 = 66.67 RWPW2 = PW2 x 2/ = (60 x 400)/90 = 266.667
3. (TWPW)
TWPW = RWPW1 66.67 + RWPW2 266.667 TWPW = 333.33 μsec
4.
= 8.0 mA
5. TWPW
90 Hz 333.33 μsec 8.0 mA 90 Hz 330 μsec8.0 mA 25
2 3
1: = 6 mA = 120 Hz PW = 200 μsec
2: = 4 mA = 120 Hz PW = 400 μsec
3: = 8 mA = 100 Hz PW = 300 μsec
1. (TR)
= 1 120 Hz + 2 120 Hz + 3 100 Hz = 340 Hz
2. (RWPW)
RWPW1 = PW1 x 1/ = (120 x 200)/340 = 70.58 RWPW2 = PW2 x 2/ = (120 x 400)/340 = 141.17 RWPW3 = PW3 x 3/ = (100 x 300)/340 = 88.23
Clinician Manual NMT-001 63 / 68
3. (TWPW)
TWPW = RWPW1 70.58 + RWPW2 141.17 + RWPW3 88.23 TWPW = 299.98 μsec
4.
= 8.0 mA
5. TWPW
340 Hz 299.98 μsec 8.0 mA 340 Hz 300 μsec8.0 mA 8.0
:
()
1. 1
2. 124
1 ____ x 1 ____ / 24 = _____
2 ____ x 1 ____ / 24 = _____
3 ____ x 1 ____ / 24 = _____
4 ____ x 1 ____ / 24 = _____
3. : = _____
Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual NMT-001 64 / 68
10 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 24,9 22,7 20,160 >25 >25 >25 >25 >25 >25 >25 >25 >25 22,9 18,9 15,4 12,4 11,0 10,390 >25 >25 >25 >25 >25 >25 24,7 20,4 18,2 15,6 11,7 10,5 9,7 9,2 8,6120 >25 >25 >25 >25 24,7 21,2 19,4 15,2 13,1 11,0 10,0 9,2 8,5 8,1 7,6240 >25 18,6 11,1 9,8 8,5 7,9 7,4 6,6 *340 22,6 12,4 9,6 8,3 7,2 *1200 8,5 *
12 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 23,3 20,8 18,7 16,860 >25 >25 >25 >25 >25 >25 >25 22,2 19,4 16,8 13,6 11,1 10,5 10,0 9,690 >25 >25 >25 >25 23,4 20,8 18,3 14,9 12,2 10,8 10,0 9,4 8,8 8,3 7,9120 >25 >25 >25 23,7 18,1 15,6 13,2 10,9 10,2 9,6 8,8 8,2 7,7 7,3 6,9240 22,8 12,8 9,5 8,3 7,3 6,7 6,4340 16,5 10,1 8,1 7,0 * *1200 7,3
14 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 23,3 20,5 18,1 15,9 14,160 >25 >25 >25 >25 >25 24,7 22,2 18,1 15,9 14,1 11,1 10,4 9,9 9,4 8,990 >25 >25 >25 >25 19,9 17,3 14,9 11,1 10,6 10,1 9,4 8,7 8,2 7,8 7,4120 >25 >25 >25 20,1 14,7 12,2 10,9 9,9 9,4 8,9 8,2 7,6 7,2 6,8 6,5240 19,1 10,7 8,6 7,6 6,6 *340 12,9 9,2 7,3 6,4 * *
16 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 24,2 20,8 18,1 15,7 13,6 11,860 >25 >25 >25 >25 24,9 22,2 19,8 15,7 13,6 11,8 10,5 9,9 9,3 8,8 8,490 >25 >25 >25 22,9 17,4 14,9 12,6 10,5 10,0 9,6 8,8 8,2 7,7 7,3 6,9120 >25 >25 23,0 17,7 12,4 10,9 10,3 9,3 8,8 8,4 7,7 7,2 6,7 6,4 6,1240 16,7 10,1 8,1 7,1 6,2 *340 11,0 8,7 6,9 * * *
18 30 >25 >25 >25 >25 >25 >25 >25 >25 24,0 22,0 18,7 15,9 13,6 11,5 10,860 >25 >25 >25 >25 22,7 19,4 17,6 13,6 11,5 10,8 10,0 9,4 8,8 8,3 7,990 >25 >25 >25 20,8 15,3 12,2 11,0 10,0 9,5 9,1 8,3 7,8 7,3 6,9 6,6120 >25 >25 20,8 15,6 11,0 10,2 9,8 8,8 8,3 7,9 7,3 6,8 6,4 6,1 *240 14,6 9,6 7,7 6,7 * *340 10,5 8,2 6,5 * * *
20 30 >25 >25 >25 >25 >25 >25 >25 24,2 22,0 20,1 16,8 14,1 11,8 10,8 10,360 >25 >25 >25 >25 20,7 17,5 15,8 11,8 10,8 10,3 9,6 8,9 8,4 7,9 7,690 >25 >25 24,2 18,9 13,5 11,0 10,6 9,6 9,1 8,6 7,9 7,4 6,9 6,6 6,3120 >25 >25 18,9 13,7 10,5 9,7 9,3 8,4 7,9 7,6 6,9 6,5 6,1 * *240 12,8 9,2 7,3 6,4 * *340 10,1 7,8 *
mA pps 60 100 156 200 260 300 330 400 450 500 600 700 800 900 10001 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25
60 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2590 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25120 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25240 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25340 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 * * *1200 >25 >25 >25 * * ***
*
*******
*********
*********
2 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2560 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2590 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25120 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25240 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 23,7 20,8 18,4 16,3 14,4340 >25 >25 >25 >25 >25 >25 >25 24,7 22,6 20,6 17,3 14,6 * *1200 >25 >25 18,9 ** *
4 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2560 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2590 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25120 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 24,2240 >25 >25 >25 >25 >25 23,7 21,9 18,4 16,3 14,4 11,3 10,5 9,6 9,1 8,4340 >25 >25 >25 24,7 19,9 17,3 15,6 12,3 10,9 10,5 9,7 9,0 * * *1200 23,7 14,4 10,1 * *
******
********
**
******
*****
*********
*********
*********
*********
*********
**
*************
**********
*********
*********
*********
*********
*********
***
************
*
*
*
***** *
6 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2560 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 23,990 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 21,5 19,4 16,5120 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 23,7 19,7 16,3 14,2 11,5240 >25 >25 >25 22,2 16,1 13,6 11,9 10,2 9,7 9,0 8,3 * * * *340 >25 >25 20,4 15,9 10,9 10,3 9,9 8,8 8,31200 16,3 10,2 *
8 30 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >2560 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 >25 22,4 20,0 17,1 14,490 >25 >25 >25 >25 >25 >25 >25 >25 >25 22,9 18,7 15,1 12,8 10,9 10,2120 >25 >25 >25 >25 >25 >25 >25 22,7 20,5 17,7 13,6 10,9 10,3 9,6 9,0240 >25 >25 17,7 12,3 10,3 9,4 9,0 8,1 7,6 7,1 *340 >25 20,6 11,6 9,9 8,8 8,0 7,7 * *1200 10,2 8,1 * *
******* *
(μs)
Clinician Manual NMT-001 65 / 68
Precision
FCC 15
(1) (2)
2
PrecisionBoston Scientific
Boston Scientific CorporationFCC
AUS Australian Sponsor AddressBoston Scienti c (Australia) Pty LtdPO Box 332BOTANYNSW 1455AustraliaFree Phone 1800 676 133Free Fax 1800 836 666
EC REP EU Authorised RepresentativeBoston Scienti c International S.A.55 Avenue des Champs PierreuxTSA 5110192729 NANTERRE CEDEXFRANCEEuropean 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 42420
Hong KongT: +852 2960 7100 F: +852 2563 5276HungaryT: +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 / NorthAfricaT: +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: +34 901 111 215 F: +34 902 267 888SwedenT: 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 3677UruguayT: +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
NMT-001
Precision™ Spinal Cord Stimulator System Clinician Manual
24 6 6 1
22200BZX00761000
SCS
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