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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
AF 7740 7741 7742 www.bostonscientific.jp © 2017 Boston Scientific or its affiliates All rights reserved. 358659-077 2017-03