physician's technical manual accolade ......physician's technical manual accolade ,...
TRANSCRIPT
PHYSICIAN'S TECHNICAL MANUAL ACCOLADE™,ACCOLADE™MRI,INGENIO™,INGENIO™MRI
PACEMAKER
REF L300, L301, L321, L310, L311, L331, J172, J173, J174, J175, J176, J177
92385051-01A92385051-01
目 次
1. 新旧対照表 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ i
2. PHYSICIAN’S TECHNICAL MANUAL 本文・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ iv
i
1. 新旧対照表
対象文書
PHYSICIAN'S TECHNICAL MANUAL
ACCOLADE™, ACCOLADE™ MRI,
INGENIO™, INGENIO™ MRI
PACEMAKER
本品の MRI 対応に伴い改訂した箇所を次ページからの新旧対照表に示します。改訂箇所は下線で示した部分です。
本新旧対照表で示したページは、PHYSICIAN’S TECHNICAL MANUAL 本文のページ数と対応しており、本文記載に対する最新の内
容は新旧対照表のとおりです。MRI 検査に関わる有害事象については、弊社の医療従事者向けの取扱説明書および製品マニュアル
のためのウェブサイトで公開している『ImageReady MR Conditional Pacing System MRI Technical Guide』をご参照ください。また、最新
の有害事象については、本品の添付文書をご参照ください。
弊社ウェブサイト
www.bostonscientific-elabeling.com
ii
【変更セクション】 2 ページ～4 ページ／プログラミングシステム(Programming System)
新 旧
プログラミングシステム(Programming System)
これらのパルスジェネレータは Model 3120 ZOOM LATITUDE プログラミングシステムまたは Model3300LATITUDE プログラミングシステムのどちらかと併用することができる。LATITUDE プログラミングシステムはパルスジェネレータシステムと併用する外部機器である。 3120 ZOOM LATITUDE プログラミングシステムには以下が含まれる。
⚫ Model 3120 Programmer/Recorder/Monitor (プログラマ、PRM)
⚫ Model 3140 ZOOM ワイヤレストランスミッタ ⚫ Model 2869 ZOOMVIEW ソフトウェアアプリケーション ⚫ Model 6577 テレメトリワンド
プログラミングシステム(Programming System)
これらのパルスジェネレータは Model 3120 ZOOM LATITUDE プログラミングシステムと併用することができる。LATITUDE プログラミングシステムはパルスジェネレータシステムと併用する外部機器である。 3120 ZOOM LATITUDE プログラミングシステムには以下が含まれる。
⚫ Model 3120 Programmer/Recorder/Monitor (プログラマ、PRM)
⚫ Model 3140 ZOOM ワイヤレストランスミッタ ⚫ Model 2869 ZOOMVIEW ソフトウェアアプリケーション ⚫ Model 6577 テレメトリワンド
Model 3300 LATITUDE プログラミングシステムには以下が含まれる。 ⚫ Model 3300 プログラマ ⚫ Model 3869 ソフトウェアアプリケーション ⚫ Ｍｏｄｅｌ 6395 テレメトリワンド
（新設）
プログラミングシステムを使用すると次のことができる。 ⚫ パルスジェネレータをイントロゲートする。
（・・・中略・・・）
⚫ 患者データを保存する。
パルスジェネレータは、2 通りの方法でプログラムすることができる。1 つは Indications-Based Programming (適応に基づく設定、IBP)を使用する自動的な方法、もう 1 つは手動による方法である。
プログラミングシステムを使用すると次のことができる。 ⚫ パルスジェネレータをイントロゲートする。
（・・・中略・・・）
⚫ 患者データを保存する。
パルスジェネレータは、2 通りの方法でプログラムすることができる。1 つは Indications-Based Programming (適応に基づく設定、IBP)を使用する自動的な方法、もう 1 つは手動による方法である。
iii
【変更セクション】 2 ページ～4 ページ／プログラミングシステム(Programming System)
新 旧
注記: プログラミングシステムはソフトウェアや該当地域での提供状況 に 応 じ て 複 数 の も の が 用 意 さ れ て お り 、 Model 3120 Programmer/Recorder/Monitor ( プ ロ グ ラ マ ) お よ び Model 3300 Programmer などさまざまなプログラミング装置を含む。本書におけるPRM およびプログラマとは、どちらもプログラミング装置を指すものとする。
注記: プログラミングシステムはソフトウェアや該当地域での提供状況 に 応 じ て 複 数 の も の が 用 意 さ れ て お り 、 Model 3120 Programmer/Recorder/Monitor (プログラマ)などさまざまなプログラミング装置を含む。本書における PRM およびプログラマとは、どちらもプログラミング装置を指すものとする。
Model 3300 LATITUDE プログラミングシステムの基本機能と使用目的は Model 3120 プログラミングシステムと同じである。異なる点としては、ソフトウェアアプリケーションのカタログ番号、ネットワーク機能および印刷機能、オンデバイスキー、データ保存オプションなどが挙げられる。詳細情報については Model 3300LATITUDE プログラミングシステムの『オペレーターズマニュアル／OPERATOR'S MANUAL』を参照すること。
(新設）
iv
2. PHYSICIAN’S TECHNICAL MANUAL 本文
(DEVICE DESCRIPTION) ............................................................................................. 1
(RELATED INFORMATION) ............................................................................................. 4 (INDICATIONS AND USAGE) ................................................................................................. 5 (CONTRAINDICATIONS) ........................................................................................................ 6 (WARNINGS) .......................................................................................................................... 6
(PRECAUTIONS) ...................................................................................................... 9 (SUPPLEMENTAL PRECAUTIONARY INFORMATION) .................... 22
(Post-Therapy Pulse Generator Follow Up)...... 22 (MRI) (Magnetic Resonance Imaging (MRI)) .............................................. 22
(Minimizing Pacemaker/S-ICD Interaction) ............................................................................................. 25
(TENS) (Transcutaneous Electrical Nerve Stimulation (TENS)) ........... 27 (RF) (Electrocautery and Radio Frequency (RF)
Ablation) .............................................................................................................................. 29 (Ionizing Radiation) ............................................................................................ 30
(Elevated Pressures) .................................................................................................... 31 (POTENTIAL ADVERSE EVENTS) ................................................................ 33
(MECHANICAL SPECIFICATIONS) ............................................................................. 35 (ITEMS INCLUDED IN PACKAGE) ............................................... 40
(SYMBOLS ON PACKAGING) ............................................................................. 40 (CHARACTERISTICS AS SHIPPED) ...................................................................... 45
(X-RAY IDENTIFIER) .................................................................................... 47
(PULSE GENERATOR LONGEVITY) .................................................... 48 (PRODUCT RELIABILITY) ...................................................................................... 55
(PATIENT COUNSELING INFORMATION) ................................................ 56 (Patient Handbook) .................................................................................. 57
(LEAD CONNECTIONS) ............................................................................................ 57 (IMPLANTING THE PULSE GENERATOR) ....................................... 60
A: (Step A: Check Equipment) .................................................... 60 B: (Step B: Interrogate
and Check the Pulse Generator) .......................................................................................... 61 C: (Step C: Implant the Lead System) .......................... 61 D: (Step D: Take Baseline Measurements) ......................... 63 E: (Step E: Form the Implantation Pocket) ...................... 65 F: (Step F: Connect the Leads to
the Pulse Generator) ........................................................................................................... 66 G: (Step G: Evaluate Lead Signals) ....................................... 70 H: (Step H: Program the Pulse Generator) .. 71 I: (Step I: Implant the Pulse Generator) ................ 72 J: (Step J: Complete and Return
the Implantation Form) ......................................................................................................... 73 (BIDIRECTIONAL TORQUE WRENCH) ........................................................... 74 (FOLLOW UP TESTING) ................................................................................ 76
(EXPLANTATION) .................................................................................................................. 77
1
(DEVICE DESCRIPTION) ACCOLADE INGENIO
( " (Mechanical Specifications)" )
• SR— • DR—
:
MRI MRI ICDICD (ICD CRT-D S-ICD )
(Therapies)
(Leads) 1
2
• IS-11 1 • IS-1 1
: IS-1 IS-1
: MRI MRIMRI MRI Technical Guide
: MRIMRI
MRI Technical Guide
(Programming System) Model 3120 ZOOM LATITUDE
LATITUDE 3120 ZOOM LATITUDE • Model 3120 Programmer/Recorder/Monitor ( PRM) • Model 3140 ZOOM • Model 2869 ZOOMVIEW • Model 6577
1. IS-1 ISO 5841-3:2013
3
• • • • • • ECG/EGM 12 • • •
2 1 Indications-Based Programming ( IBP) 1
4
: Model 3120 Programmer/Recorder/Monitor ( )
PRM
(RELATED INFORMATION)
PRM ZOOMPRM MRI MRI Technical Guide LATITUDE NXT
LATITUDE NXT LATITUDE NXT ACCOLADE INGENIO • —
5
• — LATITUDE
LATITUDE NXT LATITUDE NXT LATITUDE NXT
LATITUDE NXT
(Intended Audience)
(INDICATIONS AND USAGE)
• 2 3 • • AV (
(SA) ) • •
(MV)
6
• • VVI ( : ) •
(CONTRAINDICATIONS) (ICD)
• (S-ICD) MV
S-ICD • (MV) • • ( )
•
•
(WARNINGS) (General)
• :
7
• : 1
• :
• :
("(Minimizing Pacemaker/S-ICD Interaction)")
• Safety Core ( ) : Safety Core Safety Core
ICD ("(Minimizing Pacemaker/S-ICD Interaction)")
Safety Core MRI Protection (MRI ) "(MRI) (Magnetic Resonance Imaging (MRI))" (Handling)
• :
(Programming and Device Operations) • :
• Lead Safety Switch ( ): ICD Lead Safety Switch Off
Lead Safety Switch ICD
8
• Automatic Lead Recognition ( ): ICD Automatic Lead Recognition Off ICD
• RAAT : RAAT ICD Off
RAAT • EMI: 0.15mV
Fixed Sensitivity ( ) 2.0mV
(Post-Implant)
• :
• (MRI) : ACCOLADE MRI INGENIO MRI MRI
MRI MRIMRI
MRI MRIMRI
MRI Technical Guide" (MRI) (Magnetic Resonance Imaging (MRI))"
9
• :
(PRECAUTIONS) (Clinical Considerations)
• STAT PACE( ): STAT PACE STAT PACES-ICD
• (PMT): Minimum PVARP ( PVARP) V-APMT
• Automatic Capture ( ): Automatic CaptureAmplitude ( ) Auto ( )
• MV : MV
• MV : MVMV Off
• : 1 ( 1 60 )MV
MV( LRL )
MV • ICD
• MV
10
• MV
• MV
(Sterilization and Storage) • :
( )
• :
61cm(24 )
• : 0 50°C (32 122°F)
• :
(EMI) • :
1 11 2
(Implantation) • :
11
• :
• :
• : ZIP
• : 10μA
• :
•
• :
• RV : AAI(R)
RV RVAAI(R)
12
• :
•
•
•
• :
• MV : MVOn
• MV : MV
(Device Programming)
• :
• STAT PACE( ) : STAT PACESTAT PACE STAT PACE
• :
13
• 1.5V 3V
• R 5mV P 2mV
• Low Impedance Limit ( )High Impedance Limit ( )
• Lead Safety Switch ( ):
Lead Safety Switch Off • :
• (SVT) : SVT
SVT
• : Rate Adaptive Pacing ( )
• (VRP): MSR
Dynamic AV Delay ( AV) Dynamic PVARP AV Delay
• MTR/MSR : MTR MSR S-ICD
14
• :
• ATR Entry Count (ATR ): ATR Duration (ATR ) Entry
CountATR 2 ATR 0
2
• ATR Exit Count (ATR ): Exit CountExit Count 2
• : (
)
• Off : DDI(R) DDD(R) Off
• :
Off
• : Smart Blanking ( )
15
• Signal Artifact Monitor ( ) :
MV(SAM) MV
• Signal Artifact Monitor Off : MV
• Single-pass VDD : Single-pass VDD
• MV : MV MV
MV
( : ) • : Sensitivity ( )
Sensitivity ( )( )
• :
Fixed Sensitivity ( ) • (Patient Triggered Monitor) :
16
•
• PTM 160 PTM
• EGM ( 60 ) PTM Magnet Response
( ) Pace Async ( )3
(Environmental and Medical Therapy Hazards)
• (EMI) : EMIEMI
EMI EMI OFF
EMI
• • • • • • (EAS) ( ) • ( )
17
• TENS
• ( EKG )
(Hospital and Medical Environments) • : MV Off Off
• MV
•
• :
• ( ECG )
MV ( )
• (TENS)
Electrocautery Protection ( )("
(Post-Therapy Pulse Generator Follow Up)")
18
MV MV MVOff PRM
• :
• : 15
MVOff
•
• - -
•
("(Post-Therapy Pulse Generator Follow Up)")
• : (ESWL)ESWL
• ESWL 15cm (6 )
19
• Brady ( ) VVI VOO
• : ( )
( )
• : ( )
• (RF) :
RF ZIPRF PRM
869.85MHz • •
• : PIC
(Home and Occupational Environments)
• : EMI
20
• : (10 1 )
• • MRI
: MRI Protection Mode (MRI )" (MRI) (Magnetic Resonance Imaging (MRI))" MRI
Technical Guide • • 1.27cm (0.5 ) •
• Electronic Article Surveillance (EAS) ( ) : (RFID)
• :
15cm (6)
21
(Follow-up Testing) • :
• :
(Explant and Disposal)
• :
• :
• Brady Mode ( ) Off
• Ventricular Tachy EGM Storage ( EGM ) Off
22
(SUPPLEMENTAL PRECAUTIONARY INFORMATION) (Post-Therapy Pulse Generator Follow Up)
• • • (EGM) • EGM • ( ) • MV MV MV
• • • •
(MRI) (Magnetic Resonance Imaging (MRI)) MRI MRI
MRI MRIMRI Technical Guide
(www. bostonscientific-elabeling.com)
23
MRI (MR Conditional Pacing System Warnings and Precautions)
: ACCOLADE MRI INGENIO MRI MRIMRI MRI
MRIMRI
MRI MRI
MRI Technical Guide" (MRI) (Magnetic Resonance Imaging (MRI))"
: MRI MRIMRI
Technical Guide MRIMRI Technical Guide
: (EXPLANT) MRIEXPLANT MRI
(" (Post-Therapy Pulse Generator Follow Up)")
: MRI Protection Mode (MRI ) Brady Mode ( ) Off
MRI Protection Mode (MRI)
( ) MRI Protection Mode (MRI) Brady Mode ( ) Off
: MRI Protection Mode (MRI ) Safety Mode ()
24
• • MRI Protection Mode (MRI ) Pacing Mode ( ) Off
: MRI American College of Radiology Guidance Document for
Safe MR Practices 2 Zone III MRI MRIMRI Zone III IV
: American College of Radiology Guidance Document for Safe MR Practices 2 Zone III MRI
( ) MR ConditionalMRI MRI Zone III IV
: MRI Protection Mode (MRI )
( ) MRI
: MRI MRI Protection Safety Core ( )Pacing Mode ( ) Off MRI
Protection Safety Mode ( ) VOO RV( ) 5.0V 1.0ms
72.5min-1 : MRI
MRI
2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
25
MRI (MRI Conditions of Use) MRI MRI
MRI
MRIMRI MRI
Technical Guide (www.bostonscientific-elabeling.com) (Cardiology)
1. MRI 2. 3. MRI 4. MRI 6 5. MRI
6. 2.0V ( ) 7.
(Minimizing Pacemaker/S-ICD Interaction)
(S-ICD)
26
S-ICD • S-ICD
S-ICDS-ICD
• S-ICD2 S-ICD
S-ICD • S-ICD S-ICD
S-ICD Safety Mode ( )
Safety Mode ( )S-ICD S-ICD
• 0.25mV AGC AGC Safety Mode ( )LRL 72.5min-1
S-ICD • 5.0V 1.0ms
• S-ICD Safety
Mode LRL 2 (145min-1) S-ICD S-ICD
•
S-ICD
27
• (1) Amplitude ( )(2) Sensitivity ( )
( ) (3)
S-ICD • (EGM) S-ICD S-ICD
:
• S-ICD
S-ICDS-ICD
S-ICD Off : (1)
(2) (3)
S-ICD S-ICD
S-ICD S-ICD S-ICD " (Warnings)"
(TENS) (Transcutaneous Electrical Nerve Stimulation (TENS)) : TENS TENS
TENS
28
• TENS
• TENS • TENS
TENS • TENS • • TENS
( ) TENS
• TENS • TENS • TENS TENS
TENS PRM 1. TENS
EGM : 1 TENS
2. TENS
29
TENS(" (Post-Therapy Pulse Generator Follow Up)")
(RF) (Electrocautery and Radio Frequency (RF) Ablation)
:
MTR
• Electrocautery Protection Mode ( )
Brady Mode ( ) VVI
• •
• •
•
30
• PRM ( )
Electrocautery
Protection Mode (Ionizing Radiation)
:
• •
(" (Post-Therapy Pulse Generator Follow Up)")
31
1 1( 1 )
(Elevated Pressures)
(HBOT)(ISO)
HBOT : HBOT
5.0ATA 1000
( )( 1" (Pressure Value
Equivalencies)")
32
1. (Pressure Value Equivalencies)
5.0ATA a 40m (130 )
72.8psia b 58.1psig
Bar 5.0
kPa 500
a. 1030kg/m3 b. (psia = psig + 14.7psi)
HBOT
HBOT
("(Post-Therapy Pulse Generator Follow Up)")
HBOT
33
(POTENTIAL ADVERSE EVENTS)
( ) • (Air embolism) • (Allergic reaction) • (Bleeding) • (Bradycardia) • (Cardiac tamponade) • (Chronic nerve damage) • (Component failure) • (Conductor coil fracture) • (Death) • (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) • RV (Heart failure following chronic RV apical pacing) • (Inability to pace) • (Inappropriate pacing)
34
• (Incisional pain) • (Incomplete lead connection with pulse generator) • (Infection including endocarditis) • (Lead dislodgment) • (Lead fracture) • (Lead insulation breakage or abrasion) • (Lead perforation) • (Lead tip deformation and/or breakage) • (Local tissue reaction) • (Loss of capture) • (Myocardial infarction MI) • (Myocardial necrosis) • ( : ) (Myocardial trauma (e.g., tissue damage, valve damage)) • (Myopotential sensing) • (Oversensing/undersensing) • (PMT) ( ) (Pacemaker-mediated tachycardia,
PMT (applies to dual-chamber devices only)) • (Pericardial rub effusion) • (Pneumothorax) • (Pulse generator migration) • (Shunting current during defibrillation
with internal or external paddles) • (Syncope) • (Tachyarrhythmias, which
include acceleration of arrhythmias and early, recurrent atrial fibrillation) • (Thrombosis/thromboemboli)
35
• (Valve damage) • (Vasovagal response) • (Venous occlusion) • ( : ) (Venous trauma (e.g., perforation, dissection, erosion)) • (Worsening heart failure) MRI MRI Technical Guide
• (Dependency) • (Depression) • (Fear of premature battery depletion) • (Fear of device malfunction)
(MECHANICAL SPECIFICATIONS) ACCOLADE
36
2. - (Mechanical Specifications - All Pacemakers)
SR DR DR EL
(cm2) 29.10 28.92 35.05
(Ah) 1.0 1.0 1.6
Explant(Ah)
0.07 0.09 0.09
3. - ACCOLADE (Mechanical Specifications - ACCOLADE Pacemakers)
W x H x D (cm) (g) (cm3)
L300 4.45 x 4.81 x 0.75 23.6 11.7 RA/RV: IS-1
L301 4.45 x 5.02 x 0.75 24.8 12.2 RA: IS-1 RV: IS-1
MRI
37
3. - ACCOLADE (Mechanical Specifications - ACCOLADE Pacemakers) ( )
W x H x D (cm) (g) (cm3) L310 4.45 x 4.81 x 0.75 23.6 11.7 RA/RV: IS-1 L311 4.45 x 5.02 x 0.75 24.8 12.2 RA: IS-1 RV: IS-1
4. - ACCOLADE EL (Mechanical Specifications - ACCOLADE EL Pacemakers)
W x H x D (cm) (g) (cm3) L321 4.45 x 5.88 x 0.75 29.1 14.2 RA: IS-1 RV: IS-1
MRI
L331 4.45 x 5.88 x 0.75 29.2 14.2 RA: IS-1 RV: IS-1 ACCOLADE 402 405MHz ZIP
• : • : • (ACCOLADE) SR DR :
(402290) • (ACCOLADE) DR EL :
(402294)
38
INGENIO 5. - (Mechanical Specifications - All Pacemakers)
SR DR DR EL
(cm2) 29.78 29.78 35.98
(Ah) 1.05 1.05 1.47
Explant(Ah)
0.06 0.08 0.08
39
6. - INGENIO (Mechanical Specifications - INGENIO Pacemakers)
W x H x D (cm)
(g) (cm3)
J172 4.45 x 4.57 x 0.75 23.5 11.5 RA/RV: IS-1
J173 4.45 x 4.70 x 0.75 24.5 12.0 RA: IS-1 RV: IS-1
MRI
J175 4.45 x 4.57 x 0.75 23.5 11.5 RA/RV: IS-1
J176 4.45 x 4.70 x 0.75 24.5 12.0 RA: IS-1 RV: IS-1
7. - INGENIO EL (Mechanical Specifications - INGENIO EL Pacemakers)
W x H x D (cm)
(g) (cm3)
J174 4.45 x 5.56 x 0.75 32.0 14.0 RA: IS-1 RV: IS-1
MRI
J177 4.45 x 5.56 x 0.75 32.0 14.0 RA: IS-1 RV: IS-1
INGENIO 869.85MHz ZIP
40
• : • : • (INGENIO) SR DR : Greatbatch
(2808) • (INGENIO) DR EL :
(402125) (ITEMS INCLUDED IN PACKAGE)
• 1 •
: ( ) 1 : American College of Radiology Guidance Document for Safe MR
Practices 3 Zone III MRI( ) MR Conditional
MRI MRI Zone III IV
(SYMBOLS ON PACKAGING) ( 19" (Symbols on packaging)")
3. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
41
8. (Symbols on packaging)
42
8. (Symbols on packaging) ( )
43
8. (Symbols on packaging) ( )
(www. bostonscientific-elabeling.com)
CE
44
8. (Symbols on packaging) ( )
MRI
RV
RA RV
CRT-P RA RV LV
RF
45
(CHARACTERISTICS AS SHIPPED) ( 9" (Characteristics as shipped)")
9. (Characteristics as shipped)
Pacing Mode ( ) Storage ( )
Pacing Therapy available ( )
DDDR (DR ) SSIR (SR )
Sensor ( ) ( )
Pace/Sense Configuration ( )
RA: BI/BI (ACCOLADE )
Pace/Sense Configuration ( )
RV: BI/BI (ACCOLADE )
Pace/Sense Configuration ( )
RA: UNI/UNI (INGENIO )
46
9. (Characteristics as shipped) ( )
Pace/Sense Configuration ( )
RV: UNI/UNI (INGENIO )
Magnet Rate ( ) 100min-1
Storage ( )Storage • ( ) • • STAT PACE
StorageStorage • STAT PACE • (" (Implanting the Pulse Generator)" ) • Device Mode ( ) Exit Storage ( )
Storage Storage
47
(X-RAY IDENTIFIER)
• BSC Boston Scientific
: BSC MRI ( ) • ACCOLADE 012 • INGENIO 011
( 1" (X-ray identifier)")
1.
PRM PRM
48
PRM Summary (PRM )
(PULSE GENERATOR LONGEVITY) Explant ( )
• LRL 60min-1 0.4ms On • EGM Onset On 6
Storage ( ) ACCOLADE
10. ( ) (Pulse generator life expectancy estimation (implant to explant))
a
500750 1000 ( )
500 750 1000
SR DR DR EL SR DR DR EL SR DR DR EL
A V 3.5V
49
10. ( ) (Pulse generator life expectancy estimation (implant to explant)) ( )
a
500750 1000 ( )
500 750 1000
SR DR DR EL SR DR DR EL SR DR DR EL
50% 9.2 7.6 12.2 9.7 8.3 13.2 10.0 8.7 13.9
100% 7.9 5.9 9.5 8.6 6.8 10.9 9.1 7.4 11.8
A V 2.5V
50% 10.0 8.8 14.0 10.4 9.3 14.8 10.5 9.5 15.2
100% 9.2 7.6 12.1 9.7 8.2 13.2 10.0 8.7 13.9
A V 2.0V
50% 10.4 9.4 15.0 10.6 9.7 15.4 10.7 9.9 15.7
100% 9.8 8.4 13.5 10.2 9.0 14.3 10.4 9.3 14.8
A V 2.0V MV
50
10. ( ) (Pulse generator life expectancy estimation (implant to explant)) ( )
a
500750 1000 ( )
500 750 1000
SR DR DR EL SR DR DR EL SR DR DR EL
50% 11.1 10.0 15.8 11.3 10.3 16.4 11.5 10.5 16.7
100% 10.5 8.9 14.2 10.8 9.5 15.1 11.1 9.8 15.6
a. ZIP 1 1 40
5.0V 500 1.0ms ( ) • 70min-1 : SR 3.3 DR 1.8 DR EL 3.1 • 100min-1 : SR 2.5 DR 1.2 DR EL 2.1 LRL 70min-1 500 0.5ms 100% On
SR 8.6 (2.5V) 5.0 (5.0V) DR6.8 (2.5V) 3.0 (5.0V) DR EL 10.9 (2.5V) 5.1 (5.0V)
51
:
• • • •
• • (Patient Triggered Monitor) 60 On
5 • ZIP 1 8 • Daily Device Check (1 1 ) On 1 (
4 ) 10 Daily Device Check 4 9
• LATITUDE 1 5 40
• MRI Protection (MRI ) ( On ) 245
• 6 Storage ( ) 80LRL 60min-1 2.5V 0.4ms
500 100%
52
• • •
INGENIO 11. ( ) (Pulse generator life expectancy
estimation (implant to explant)) a b
500750 1000 ( )
500 750 1000
SR DR DR EL SR DR DR EL SR DR DR EL
A V 3.5V
50% 8.5 7.0 9.9 9.0 7.5 10.7 9.2 7.8 11.2
100% 7.3 5.5 8.0 7.9 6.3 9.0 8.4 6.8 9.6
A V 2.5V
53
11. ( ) (Pulse generator life expectancy estimation (implant to explant)) ( )
a b
500750 1000 ( )
500 750 1000
SR DR DR EL SR DR DR EL SR DR DR EL
50% 9.3 7.9 11.3 9.5 8.4 11.8 9.6 8.6 12.1
100% 8.5 6.9 9.8 8.9 7.5 10.7 9.2 7.9 11.2 a. ZIP 1 3 20
b. LATITUDE Daily Alert Interrogation (1 1
) On 1 4 5.0V 500 1.0ms ( ) • 70min-1 : SR 3.2 DR 1.7 DR EL 2.7 • 100min-1 : SR 2.4 DR 1.1 DR EL 1.9 LRL 70min-1 500 0.5ms 100% On
SR 7.9 (2.5V) 4.7 (5.0V) DR6.3 (2.5V) 2.9 (5.0V) DR EL 8.9 (2.5V) 4.3 (5.0V)
54
:
• • • •
• • MV Off 5 • (Patient Triggered Monitor) 60 On
5 • ZIP 1 9 • LATITUDE 1 5 14
• MRI Protection (MRI ) ( On ) 24
5 • 6 Storage ( ) 80 LRL
60min-1 2.5V 0.4ms500 100%
• •
55
• PRM Summary (PRM ) Battery
Detail Summary ( )
(PRODUCT RELIABILITY)
• (Premature battery depletion) • (Sensing or pacing issues) • (Error codes) • (Loss of telemetry)
( )www.bostonscientific.com CRM Product Performance Report
56
(PATIENT COUNSELING INFORMATION)
• —
• • (
) • —
• MRI — MRI • EMI • (" (Product Reliability)") • ( ) • ( ) • • —
• ID — ID
: MRI ID
57
(Patient Handbook)
MRI
(LEAD CONNECTIONS)
:
: MRIMRI
MRI Technical Guide
:
ACCOLADE
58
RA/RV: RA/RV
2. RA/RV: IS-1 (Lead connections and setscrew locations, RA/RV: IS-1)
RA: RV: RA RV
3. RA: IS-1 RV: IS-1 (Lead connections and setscrew locations, RA: IS-1, RV: IS-1)
IS 1UNI/BI
IS 1
IS 1UNI/BI
UNI/BI RV
RA
59
INGENIO
RA/RV
4. RA/RV: IS-1 (Lead connections and setscrew
locations, RA/RV: IS-1)
5. RA: IS-1 RV: IS-1 (Lead connections and setscrew locations, RA: IS-1 RV: IS-1)
:
60
(IMPLANTING THE PULSE GENERATOR)
: American College of Radiology Guidance Document for Safe MR
Practices 4 Zone III MRI( ) MR Conditional
MRI MRI Zone III IV
A: (Step A: Check Equipment)
PRM ( )
• • • PSA •
4. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
61
B: (Step B: Interrogate and Check the Pulse Generator)
1. PRM
Storage ( )
ACCOLADE ZIP ZOOM USBPRM
PRMPRM ZIP
LED End Session ( )RF
ZIP ZOOMZIP ZIP
2.
BOL ( )
3.
C: (Step C: Implant the Lead System)
62
• •
: : : MRI MRI
MRI MRI Technical Guide
: MRIMRI
MRIMRI Technical Guide
:
: AAI(R) RVRV AAI(R)
:
63
:
: MRI MRIMRI Technical Guide
D: (Step D: Take Baseline Measurements)
()
• (PSA) • 10 ( ) ( )
PSA 12. (Lead measurements)
( ) ( )
R Amplitudea b > 5mV > 5mV
P a b > 1.5mV > 1.5mV
R b c d < 100ms < 100ms
64
12. (Lead measurements) ( ) ( ) ( )
( ) < 1.5V < 2.0V
< 3.0V < 3.5V
( ) < 1.5V < 3.0V 5.0V 0.5ms
()
> Low Impedance Limit
( )e < High
Impedance Limit ( )f
> Low Impedance Limit
( )e < High
Impedance Limit ( )f
a. 2mV
b. R
c. R 135ms ( )
d. e. Low Impedance Limit ( ) 200 500 f. High Impedance Limit ( ) 2000/2500
3000
• •
65
• E: (Step E: Form the Implantation Pocket)
()
: MR Conditional MRI
MRI Technical Guide ( )
• Penrose
• •
66
F: (Step F: Connect the Leads to the Pulse Generator)
Automatic Lead Detection ( )
( )
( )(200 2000 200 2000 )
( )Storage
:
: (2000 )
: EGM PaceSafe2
ACCOLADE (ALR)
ALR On On Off ALR (200 2000 )
ALR
2
67
Storage
EGM
StorageLRL 2
(" (Lead Connections)" )
: RA RV 1. RV RV
RV : RV
• IS-1 RV IS-1 RV
2. • IS-1 RA IS-1
68
( "(Bidirectional Torque Wrench)" )
1.
2. 3. 90
( 6 " (Inserting the torque wrench)")
:
:
•
•
•
69
6. (Inserting the torque wrench)
4. EasyView
:
:
: IS-11mm
5.
70
6. 7. 8.
9.
:
G: (Step G: Evaluate Lead Signals)
1. 2. EGM
( 23 " (Lead measurements)")
:
3.
71
ACCOLADE High Impedance Limit ( ) 20002000 3000 250 Low Impedance Limit ( )
200 200 500 50 INGENIO High Impedance Limit ( ) 20002000 2500 250 Low Impedance Limit ( )
200 200 500 50
• ( )
• : High Impedance Limit
Low Impedance Limit • • ( )
H: (Step H: Program the Pulse Generator) 1. PRM
2.
•
2 3
72
• R •
• MTR MTR
• MSR
MSR • Atrial Refractory ( ) AV Delay (AV )
MTR 2:1 • RVAC On
• AGC
Fixed Sensing ( ) • Noise Response (
) Inhibit Pacing ( )
• MV MV Off
I: (Step I: Implant the Pulse Generator) 1.
73
2. ( "
(Lead Connections)" )
:
3.
4. Electrocautery 5.
: Sensitivity ( )Sensitivity ( )
( )
6. PRM ( ) J: (Step J: Complete and Return the Implantation Form)
10 Warranty Validation and Lead Registration
Warranty Validation and Lead Registration
74
(BIDIRECTIONAL TORQUE WRENCH) ( 6628) #2-56
( )
:
()
1. 20 30 ( 7 "
(Rotating the torque wrench to loosen a stuck setscrew)")
2. ( ) () 3 ( 7 "
(Rotating the torque wrench to loosen a stuck setscrew)")
75
3. 46501 #2
4. 5.
7. (Rotating the torque wrench to loosen a stuck setscrew)
76
(FOLLOW UP TESTING)
(" (Implanting the Pulse Generator)"" " )
(Predischarge Follow-up) PRM ( )
1. Summary ( ) 2. 3. 4. 5. Quick Notes Patient Data ( ) 6.
Histogram ( ) Tachy Counters ( )Brady Counters ( ) Reset ( )
(Routine Follow-up) 3 4
One Year Remaining ( 1 ) 90min-1
3 1
77
: (Explant ( ) ) 3 One Year Remaining 3
1. Summary ( ) 2. 3. Quick Notes Patient Data ( ) 4. Arrhythmia Logbook ( )
5.
6. ( AV Delay
) : AV Delay
(EXPLANTATION) :
: 1
78
• • ( ) •
:
: :
:
• Brady Mode ( ) Off • Ventricular Tachy EGM Storage ( EGM ) Off
• • •
79
•
•
•
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