PHYSICIAN'S LEAD MANUAL

INGEVITY™ MRI Pace/Sense Lead

IS-1 Bipolar Connector

Extendable/Retractable Fixation

Straight

7740, 7741, 7742

2018-06

92227277-01A

(INFORMATION FOR USE) ................................................................ 1 (Device Description) .................................................................... 1

(Related Information) ...................................................................... 2 MR Conditional (MR Conditional System Information) ........ 2

(Indications and Usage) ......................................................................... 3 (Contraindications) ................................................................................. 3 (Warnings) .............................................................................................. 3

(Precautions) ............................................................................ 4 (Potential Adverse Events) ............................................. 9

(PRE-IMPLANT INFORMATION) ........................................... 10 (Surgical Preparation) ................................................................ 10

(Items Included) ............................................................................ 11 (Accessories) .................................................................................... 11

(Vein Pick) ............................................................................. 11 (Radiopaque Suture Sleeve) ............ 11

(Stylets) .................................................................................. 11 (Fixation Tool) ............................................................ 12

(Lead Cap) .......................................................................... 13 (IMPLANTATION) ................................................................................. 13

(Inserting the Stylet) ......................................................... 13 (Handling the Fixation Helix) ................................... 14

(Inserting the Lead) .................................................................. 15 (Positioning Lead in Right Atrium) .......................... 18 (Positioning Lead in Right Ventricle) ...................... 19

(Lead Fixation) ......................................................................... 20 (Checking for Lead Stability) ...................................... 22

(Repositioning the Lead) ...................................................... 22 (Evaluating Lead Performance) ........................................ 23

(Securing the Lead) .................................................................. 24 (Connection to a Pulse Generator) .................... 27

(Electrical Performance) ................................................................ 27 (POSTIMPLANT) .............................................................................. 28

(Postimplant Evaluation) ..................................................... 28 (Explantation) ....................................................................................... 28

(SPECIFICATIONS) ................................................................................. 29 ( ) (Specifications (Nominal)) ...................................................... 29

(Lead Introducer)........................................................ 31 (Symbols on Packaging) ................................................. 31

1. Cathode (-) 2. Anode (+) 3. 4. IS-1

Boston Scientific Corporation : IMAGEREADYINGEVITY IROX

1

(INFORMATION FOR USE)

(Device Description)

• : ( )

• IS-1 1: IS-1

• MR Conditional: MR ConditionalMRI

("MR Conditional (MR Conditional System Information)" 2)

• IROX : IROX • :

(" 5 ( )" 29) • :

• :

()

Cathode (-)

• :

• :

MRI MR Conditional

(PTFE)(ETFE)

1. IS-1 ISO 5841-3:2013

2

• : (" (Stylets)" 11)

(Related Information)

MRI MRI Technical Guide

(Intended Audience)

MR Conditional (MR Conditional System Information)

MR ConditionalMRI 2MR Conditional MRI Technical Guide

MRIMR Conditional

Programmer/Recorder/Monitor ( PRM) PRMMR Conditional

MRIMRI Technical Guide

MRI (Lead Implant-related MRI Conditions of Use)

MRI MRI

MRI Technical Guide MR Conditional

• MRI 3 •

• • MRI

2. INGEVITY MRI SAMURAI

INGEVITY MRI 2 3. MRI

3

• MRI 6

• MRI • 2.0V ( )

(Indications and Usage)

• ()

(Contraindications)

• 0.91mg • ( )

(Warnings) (General)

•

• 1

•

•

CPR ( )

•

4

(Handling) •

•

(Implant Related) • MRI Zone III American

College of Radiology Guidance Document for Safe MR Practices4

Zone III MRI(

) MR Conditional MRIMRI Zone III IV

•

•

(Post-Implant) • (MRI) MRI ( MRI Technical

Guide ) MRIMR Conditional

MRI MRI Technical Guide

•

(Precautions) (Clinical Considerations)

•

Physicians' Desk Reference™5

4. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007. 5. Physicians' Desk Reference Thomson Healthcare, Inc.

5

(Sterilization and Storage) •

()

• 25°C(77°F) 15 30°C(59 86°F)

50°C(122°F) •

1 1 1 2

(Handling) •

•

•

•

•

•

(Implantation) •

•

6

•

• 10 A

•

•

•

•

•

•

•

•

( )

•

7

•

•

3 3 1

6 •

•

•

•

•

•

•

•

6. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator

leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE. 1993;16:445–457.

8

(Hospital and Medical Environments) •

• • •

•

•

• (RF)

(MTR)

•

• •

• PIC

9

(Follow-up Testing) •

(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) • (Incomplete lead connection with

pulse generator)

10

• (Infection including endocarditis) • (Lead dislodgment) • (Lead fracture) • (Lead insulation breakage or abrasion) • (Lead tip deformation and/or breakage) • (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)) MRI MRI Technical Guide

(PRE-IMPLANT INFORMATION)

(Surgical Preparation)

•

11

•

•

(Items Included) :

(Accessories)

(Vein Pick)

(Radiopaque Suture Sleeve)

:

( 6402)

:

(Stylets)

12

1.

( )

(cm) (

)

( )

7740 ( )

45 5012 ( )

=

5003 ( ) X =

6053 ( J )

=

6506 ( J )

=

7741 ( )

52 5013 ( )

=

5004 ( ) X =

6054 ( J )

=

6586 ( J )

=

7742 ( )

59 5014 ( )

=

5005 ( ) X =

6055 ( J )a

=

6603 ( J )a

=

a.

:

(Fixation Tool)

(" 1 " 13)

13

1.

(Lead Cap)

(IMPLANTATION) :

5 10cm

: MR ConditionalMRI Technical Guide

MR Conditional MR Conditional MR Conditional

MRI Technical Guide

: MRIMRI

(Inserting the Stylet)

1.

2. ( 10cc 12cc )

(" 2 " 14) :

14

2.

3. (" 3 " 14)

:

3.

4. :

(Handling the Fixation Helix)

1.

4.

2. (11 )

:

(" 5 ( )" 29)

15

:

:

:

:

3.

:

4.

(Inserting the Lead)

•

1

:

5.

16

•

: 3

3 1

7

( ) 8

1. St ( ) Cp ( ) (" 6

" 17)

7. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator

leads, and failure of central venous catheters adjacent to the sternoclavicular joint PACE. 1993;16:445–457.

8. Magney JE, et al. A new approach to percutaneous subclavian venipuncture to avoid lead fracture or central venous catheter occlusion. PACE. 1993;16:2133–2142.

17

6.

2. St Cp 3(Ax )

3. 3 (V )

4. 1 2cm(

2cm ) (" 7 " 17)

7.

18

5.

(Positioning Lead in Right Atrium) 2 J

1.

:

2. 3. J

4.

(" 8 " 19) 5.

(" (Lead Fixation)" 20) :

19

8.

(Positioning Lead in Right Ventricle)

1.

:

2.

Anode (+)

3. 4.

:

5.

:

20

9.

6. :

(Lead Fixation)

( )

:

1.

a. b.

21

10.

2. 3. (1

1 ) :

:

:

: (" 5 ( )" 30)

( )

4.

(" 2 " 21) 2.

5.

:

22

(Checking for Lead Stability)

1. 8 10cm ( 5 ) :

2.

3.

• J

• J L L

4.

5. :

(Repositioning the Lead)

1.

2.

: (" 5 ( )" 30)

( )

:

23

3.

(Evaluating Lead Performance) (PSA)

1.

2. PSA

• Cathode (-) PSAAnode (+)

3. 3.

( 0.5ms) 1.5V 1.0V

P R 2.0mV 5.0mV

200 2000 200 2000

• PSA

•

4. • PSA •

•

•

24

• 10

•

•

5.

PSA

6. (PSA)

(Securing the Lead)

:

:

:

:

:

25

(Percutaneous Implant Technique) 1.

(" 11 " 25)

11.

26

2. 2

3.

(Venous Cutdown Technique) 1.

2. 3. (" 12

" 26)

12.

27

4. 2

5.

(Connection to a Pulse Generator)

1.

2.

3.

:

4.

:

:

5.

(Electrical Performance) 1. 2.

(" (Connection to a Pulse Generator)"27)

3. EGM •

28

•

•

4.

(POSTIMPLANT)

(Postimplant Evaluation)

:

:

CPR ( )

:

(Explantation) : 1

• • ( )

•

29

:

• • • •

•

•

(SPECIFICATIONS)

( ) (Specifications (Nominal)) 4.

(cm) 7740 45 7741 52 7742 59

5. ( )

IS-1BI

IS-1 IS-1

(1 1 )a 7

J 8

30

5. ( ) ( )

a 30

()

1.8 mm

0.1 mm

:

4.5 mm2

10.7 mm

Anode (+) 20 mm2

:

2.0 mm (6F)

Anode (+) 2.0 mm

1.9 mm

1.2 mm

:

(55D)

316L

IS-1 316L

(IROX) Pt-Ir

Anode (+) (IROX) Pt-Ir

MP35N™ b

0.91 mg

Pt-Ir

31

5. ( ) ( )

Maximum Lead Conductor Resistance ( ):

Anode (+) ( )

45 cm: 130 52 cm: 152 59 cm: 174

45 cm: 180 52 cm: 209 59 cm: 238

a.

b. MP35N SPS Technologies, Inc.

(Lead Introducer) 6.

6F (2.0mm)

9F (3.0mm)

(Symbols on Packaging)

7.

32

7. ( )

CE

MR Conditional

Memo

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