physician's lead manual fineline ii sterox · 2020-05-21 · 1 +0[(description)fineline™ ii...

PHYSICIAN'S LEAD MANUAL

Implantable Lead

FINELINE™ II STEROX

4456/4457/4458/4459/4479/4480

2016-03

91095046-01A

Boston Scientific FINELINE IMAGEREADY IROX

(DESCRIPTION) ................................................................ 1MR Conditional (MR Conditional System

Information) ...................................................................................1MRI (Implant-related MRI Conditions

of Use) ...........................................................................................1(Lead Features) .........................................................2

(INDICATIONS) ................................................................. 2(CONTRAINDICATIONS) .................................................. 2(WARNINGS) ..................................................................... 2

(PRECAUTIONS) ................................................ 3(General) ....................................................................3

(Handling) .............................................................................4(Implanting) .......................................................................4

(POTENTIAL ADVERSE EVENTS) .......... 5(IMPLANT INFORMATION) ..................... 7

(Precautions) ..............................................................7(Sterilization) ............................................................................7(Storage) ..................................................................................7

(Handling) .............................................................................7(Precautions) ...........................................................8

(General Information) .................................................8(Precautions) ...........................................................8

(Insertion Procedures) .......................................................8(Threshold Measurements) ...........................................9

(Securing the Lead) ................................................. 10(POSTIMPLANT) ...................................................... 12

(RETURNING EXPLANTED PRODUCTS) .... 12(SYMBOLS ON PACKAGING) ............................. 13

(SPECIFICATIONS) ......................................................... 14

1

(DESCRIPTION)FINELINE™ II4456 4457 4458 4459 4479 4480

MR Conditional (MR Conditional System Information)

MR ConditionalMRI

MRI ( MR Conditional) MR Conditional

ImageReady MR Conditional Pacing System MRI Technical Guide ImageReady MR Conditional Defibrillation System MRI Technical Guide (MRI Technical Guide )

MRIMR Conditional

Programmer/Recorder/Monitor (PRM) PRM MR Conditional

MRIMRI Technical Guide

MRI (Implant-related MRI Conditions of Use)MRI

MRIMRI

Technical Guide MR Conditional

2

(Lead Features)0.75mg

21

(IROX™)

IS-11

(INDICATIONS)(4456 4457

4458 4459) (4479 4480)

(CONTRAINDICATIONS)

• ( )• 0.75mg

(WARNINGS)

: MRIMRI Technical Guide

• MRI ( MRI Technical Guide )MRI

MR Conditional


1. IS-1 ISO 5841-3:2013

3

• American College of Radiology Guidance Document for Safe MR Practices 2

Zone III MRI(

) MR ConditionalMRI MRI Zone

III IV•

•

•

• ( )

• 1

(PRECAUTIONS)(General)

•(7 " (Sterilization)" )

•

2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

4

: MR ConditionalMR Conditional

MR Conditional


: MRIMRI

•

•

Physicians' Desk Reference™ 3

(Handling)•

••

•

(Implanting)•

•

•

3. Physicians' Desk Reference Thomson Healthcare Inc.

5

(POTENTIAL ADVERSE EVENTS)

( )

• (Air embolism)• (Allergic reaction)• (Arterial damage with subsequent

stenosis)• (Bleeding)• (Bradycardia)• (Breakage/failure of the

implant instruments)• (Cardiac perforation)• (Cardiac tamponade)• (Chronic nerve damage)• (Component failure)• (Conductor coil fracture)• (Death)• (Electrolyte imbalance/dehydration)• (Elevated thresholds)• (Erosion)• (Excessive fibrotic tissue growth)• ( ) (Extracardiac stimulation

(muscle/nerve stimulation))• (Fluid accumulation)• (Foreign body rejection phenomena)• (Formation of hematomas or seromas)• (Heart block)• (Hemorrhage)• (Hemothorax)• (Inability to pace)• ( : ATP )

(Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing))

• (Incisional pain)

6

• (Incomplete lead connection with pulse generator)

• (Infection including endocarditis)• (Lead dislodgment)• (Lead fracture)• (Lead insulation breakage or

abrasion)• (Malignancy or skin

burn due to fluoroscopic radiation)• ( : ) (Myocardial trauma (e.g.,

tissue damage, valve damage))• (Myopotential sensing)• (Oversensing/

undersensing)• (Pericardial rub effusion)• (Pneumothorax)• (Pulse generator and/

or lead migration)• (Syncope)•

(Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation)

• (Thrombosis/thromboemboli)• (Valve damage)• (Vasovagal response)• (Venous occlusion)• ( : ) (Venous trauma (e.g.,

perforation, dissection, erosion))

MRIMRI MRI

Technical Guide

7

(IMPLANT INFORMATION)

: MR Conditional


(Precautions)•

•

(Sterilization)

( 1 2)

(Storage)25°C(77°F) 15 30°C(59 86°F)

50°C(122°F)

(Handling)

8

(Precautions)•

••

•

(General Information)

() (

)

(7Fr )

(Precautions)•

(Insertion Procedures)

( )

( )(

3 )

( 4 )

9

2

(Atrial Placement)1. J

2.

3.J

(Ventricular Placement)1.

( 5)

2.

3.

(Threshold Measurements)

10

(Ventricular)500 0.6V 1.2mA

1.0V 2.0mA5.0mV

200 2000

(Atrial)500 1.0V 2.0mA

1.5V 3.0mA0.5 4.0mV

1.5mV200 2000

:

()

(Securing the Lead)

( 6 )

:•

•

11

1.( 1)

2. ( 2)

3. ( 3)

4.( 4)

12

5.( 5)

6.( 6)

(POSTIMPLANT)

(RETURNING EXPLANTED PRODUCTS):

:

13

(SYMBOLS ON PACKAGING)

CE

14

(SPECIFICATIONS)

MR Conditional

4479/4480 ( )4456/4457 ( )

4458/4459( )

( )7 Fr/2.3 mm 7 Fr/2.3 mm

(0.75 mg) (0.75 mg)

( )

1.9 mm (5.7 Fr) 1.9 mm (5.7 Fr)5 mm2 5 mm2

IROX ( ) IROX ( )( )a

( )31 mm2 33 mm2

16 mm 16 mm

( ) ( )

55D 80A4456: 52 cm4457: 58 cm4479: 45 cm4480: 52 cm

4458: 52 cm4459: 58 cm

1.7 mm (5 Fr) 2 mm (6 Fr)

15

40 4040 40

3.2 mm (IS-1b ) 3.2 mm (IS-1b)316L 316L

c 10 N 10 N

1.6 mm 1.6 mm2.7 mm 2.7 mm5 mm 5 mm

a. (PEG)

b. IS-1 ISO 5841-3:2013

c. Intermedics prEN45502-2 (1996 9 16 )

4479/4480 ( )4456/4457 ( )

4458/4459( )

physician's lead manual fineline ii sterox · 2020-05-21 · 1 +0[(description)fineline™ ii...

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