Precision Spinal Cord Stimulator System Clinician Manual...Precision Spinal Cord Stimulator System Clinician Manual SC-1110 Precision Implantable Pulse Generator SC-2158-xx Linear

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


Clinician Manual NMT-001 2 / 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



............................................................................................. 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


IPG ................................................................................ 36 ............................................................................... 37

IPG ............................................................................................... 37 ......................................................................................................................... 38 Remote Control ................................................................................................ 40

................................................................................................................ 44 ....................................................................................................................................... 45

............................................................................................................ 46 ...................................................................................... 51

....................................................................................................................................... 51 1 ....................................................... 52

.......................................................................................................... 55 Stimulator Lead ................................................................................................... 55

......................................................................................... 55 ....................................................................................................... 56

................................................................................................................. 59



© 2011 Boston Scientific Corporation or its affiliates. All rights reserved.

Boston Scientific Corporation Boston Scientific Corporation

Boston Scientific Corporation

BionicNavigator™ Precision™ Boston Scientific Corporation


Boston Scientific Precision

Spinal Cord Stimulator (SCS)

Boston ScientificPercutaneous Lead Lead Extension SplitterSurgical Paddle Lead Implantable Pulse Generator (IPG)

IPG

BionicNavigator



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


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 (Precision )

SCS

SCS


Charger

Charging BeltCharger

(MRI) Precision SCSMRI

MRI

Lead Stimulator "

"

/

SCS

Lead

IPG

Stimulator

IPG

IPG

Stimulator

Stimulator



/

Stimulator

:

14

14

/

2

2 kg (5 )

Lead

2

Stimulator Stimulator" "

StimulatorStimulator

Stimulator

Lead Lead

StimulatorLead


LeadStimulator

( 4 )

Stimulator

Remote Control Charging System

35 °C (95 °F) Charger


–20 60 °C (-4 140 °F)

Remote ControlCharger

IPG

Boston Scientific


Lead

Lead

IPG



(CSF)

MRI

Lead Lead

Lead

Stimulator

IPG Lead

Remote Control

/

5

IPG

IPG

IPG

IPG


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

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)


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)



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


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



: 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


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



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


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



:

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


A: 26 Trial Lead

B: 27 Lead

C: Percutaneous LeadIPG 27

Lead

D: Paddle LeadIPG 27 Lead

SCS



Trial Lead 1. Lead Insertion Needle

LeadInsertion Needle

2. Insertion Needle

LeadLead

3. Lead

4.

5. Splitter 21 Splitter Lead

Lead


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



Lead Lead Extension

1. Tunneling Tool

2.

3.

4. :

5.

6.

7. Tunneling Tool

Lead


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



4. Lead Lead

Extension connector

5. LeadLead

Lead

: Lead Lead

6. Lead Extension

7. Lead Extension

31 Trial Stimulator

8. 34 IPG

Trial Stimulator


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



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


IPG 1. Lead Tunneling

ToolLead Suture Sleeve

2. IPG IPG

3. IPG2.0 cm

2.0 cm

: IPG

IPG

4. IPG28 Lead Lead

Extension



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


: 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.



IPG 1. IPG

2. IPG

3. LeadLead Extension Splitter

4. 34 IPGIPG

Lead

5. Boston ScientificIPG


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



24"Recharge Stimulator Now"

Remote ControlStimulator

Stimulator Remote Control

:

Charger


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


4. Charging BeltCharger Stimulator

:

Charger

StimulatorCharger Stimulator

( )

Charger : Charger Charging Belt


Stimulator ()

: Charging Belt

Charger

Charger

5. Stimulator2 ChargerCharger Charging Belt

ChargerBase Station

( 2 ) ChargerStimulator

: • 10

4 1 4

4

• 2

• Remote Control IPG



Remote Control

Remote Control (RF)

60 cm (2 ) Stimulator

Remote Control ()

Remote Control"Release P To Unlock" P

1. 4.

2. / 5. /

3. /

/ /




Remote Control StimulatorRemote Control

1 2

Remote Control Stimulator

3 4Stimulator

Remote Control "Searching"

StimulatorRemote Control

( ) Remote ControlStimulator

:

: Remote ControlStimulator

Remote Control

Remote Control " "



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

:

(__)


2.

3. P

1. P 31

2. P

3.

4

( )

1.

2. ( )



Remote Control

BionicNavigator

(BionicNavigator)

1. Remote Control 3

"Width"

2. 1

3.

4.

3

"Rate" 5. 1

6.

7.

3

Remote Control 1Stimulator 1


1. P Remote ControlRemote Control

Stimulator

2. StimulatorRemote Control "Link?"

PRemote Control

Stimulator


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




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


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



: Stimulator

Remote Control

1 8 ("1-L" Lead )

19 16 ("2-R" Lead )

9

(4500 )

( / )

1 8

9 16


"Measure Again?"

P

3 – "Clear

Link" Stimulator

P



Enter Password

P /

Remote Control StimulatorRemote Control "Link?"

Remote Control

Remote Control

4 –

"Language" 7

P

P

Remote Control


( ) 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 ( )



1


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%



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%


Stimulator Lead

Boston ScientificLead/Lead Extension/Splitter

Lead

1Boston Scientific1 1

1



Precision

2005 CE


1

: BF

WEEE



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


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



1. Precision

2. 1

()

Precision

Stimulator

: • "*" Precision

"*"

•

Boston Scientific


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



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


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. : = _____



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)


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


24 6 6 1

22200BZX00761000

SCS

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