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2016-08
91144204-01A
S-ICD
3200
Boston Scientific : EMBLEM ImageReady AF Monitor
1 http://www.bostonscientific.com/patents
© Copyright 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
AC Alternating Current ( ) LCD Liquid Crystal Display ( )
AF Atrial Fibrillation ( ) MRIMagnetic Resonance Imaging (
)
ATPAnti-tachycardia Pacing (
) NSR Normal Sinus Rhythm ( )
CRTCardiac Resynchronization Therapy ( ) RF Radio Frequency ( )
CPRCardiopulmonary Resuscitation (
) RFIDRadio Frequency Identification (
)
ECG Electrocardiogram ( ) S-ECGSubcutaneous Electrocardiogram ( )
EMI Electromagnetic Interference ( ) S-ICD
Subcutaneous Implantable Cardioverter Defibrillator (
)
EOL End of Life ( ) USBUniversal Serial Bus (
)
ERIElective Replacement Indicator (
) VAC Voltage Alternating Current ( )
ESD Electrostatic Discharge ( ) VF Ventricular Fibrillation ( )
FCCFederal Communications Commission ( ) VT Ventricular Tachycardia ( )
GUIGraphic User Interface (
)
(Description) ......................................................................................................................1
(Intended Use of Programmer) .............................................................1
(Indications for Use) ..........................................................................................................1
(Contraindications) ...........................................................................................................1
(Related Information) ................................................................................................2
(Programmer Warnings and Precautions) ..............2
(Programmer Warnings).....................................................................................2(General) .................................................................................................................................................2
(Conditions for Operation) .....................................................................................................3(Programmer Precautions) .............................................................4
(General) .................................................................................................................................................4(Storage and Handling) .......................................................................................4
(Implantation) ..................................................................................................................................5(Conditions for operation) ......................................................................................................5
S-ICD (S-ICD System Warnings and Precautions) .......5
S-ICD (S-ICD System Warnings) ............................................................................6(General) .................................................................................................................................................6
(Post-Implant) ..............................................................................................................................6(Clinical Considerations) ............................................................................................7
(Implantation) ..................................................................................................................................7(Device Programming) ......................................................................................7
S-ICD (S-ICD System Precautions) .....................................................8(Environmental and Medical Therapy Hazards) ..................8
(Hospital and Medical Environments) ..........................................................8(Follow-up Testing) ..............................................................................................12
(Explant and Disposal) ........................................................................................................13(Supplemental Precautionary Information) ...............................13
(OPERATION)
(Programmer Setup) ...................................................................................16
(Packaging) ................................................................................................................................................16(Programmer Controls and Connections) ................16
(Charging the Programmer) ........................................................................................17
(Using the Programmer) .............................................................................18
(Turning the Programmer On) ...........................................................................18
(Changing the Programmer Volume Level) .......................................... 18(Placing the Programmer in Suspend Mode) .......... 18
(Turning the Programmer Off) ........................................................................ 19(Using the Programmer Touch Screen) ....................................... 19
(Using the Wand) ................................................................................................................... 19(Navigation) .......................................................................................................................... 20
(Screen Header) .......................................................................................................................... 21(Navigation Bar) ......................................................................................................... 21(Restarting the Programmer) .............................................................................. 21
(Configuring the Programmer) ................................................................. 24
(Configuring Programmer Settings) ............................................................ 24(Date and Time Format) .................................................................................................... 25
(Time Zone) ............................................................................................................................... 26(Language Preference) ................................................................................................................ 27
(Printer Selection) .............................................................................................................. 27(Programmer Software Version) ................................................ 29
Bluetooth™ (Bluetooth™ Data Export) .............................................. 29
(Programmer Modes of Operation)................................................ 31
(Online Behavior) ...................................................................................................... 31(Offline Behavior) ...................................................................................................... 31
(Stored Patient Sessions) ................................................................... 31(To view stored patient sessions) ................... 32
(Modes of Operation for the Pulse Generator) ............... 32
Shelf ( ) (Shelf Mode) ................................................................................................................... 32Therapy On ( ) (Therapy On Mode) ............................................................................... 32Therapy Off ( ) (Therapy Off Mode) ............................................................................... 33MRI Protection (MRI ) (MRI Protection Mode) .................................................................... 33
S-ICD (Connecting and Disconnecting from the
S-ICD Pulse Generator) .......................................................................................................... 34
(Scanning for Pulse Generators) ..................................................... 34(Connecting to a Pulse Generator).................................................... 35
Shelf ( ) (Connecting to a Pulse Generator inShelf Mode)..................................................................................................................................................... 35
(Connecting to an Implanted Pulse Generator) ...... 35(Ending a Patient Session) ................................................................................. 36
(Programming the Pulse Generator at
Implant) .................................................................................................................................. 38
(Entering Electrode Information) .............................................................................. 38(Creating the Patient Chart) .................................................................................... 39
(Automatic Setup) ........................................................................................................... 40(Programming Therapy Parameters) ......................................... 43
(Defibrillation Testing) ............................................................................................................ 45
(Performing a Follow-up) .................................................................... 48
(Sensing Configuration and Automatic Setup) ........ 48(Viewing Pulse Generator Status) ........................................... 48
(Viewing Stored Episodes) ............................................................................... 49
(Printing Reports from the Programmer) ........................ 51
(Printing Reports) .............................................................................................................. 51(Summary Report) .............................................................................................................. 52
S-ECG (Captured S-ECG Report) ............................................................................. 53(Episode Reports) ........................................................................................................ 54
(Export Patient Data) ................................................................... 55
Bluetooth™ (Export using Bluetooth™ wireless tech-nology) ................................................................................................................................................................. 55microSD™ (Export using a microSD™ card) ........................................... 56
S-ECG (S-ECG Features) ................................................................................................... 57
S-ECG (S-ECG Rhythm Strip Markers) ......................................................................... 57S-ECG (S-ECG Scale Settings) ............................................................................................. 58S-ECG (Capturing and viewing S-ECG Strips) ......................................... 59
S-ECG (To manually capture a new S-ECG rhythm strip) ...................................................................................................................................................... 60
S-ECG (Viewing previously-captured S-ECGs) ............................... 60
(Utilities Menu) ................................................................................... 62
S-ECG (Acquire Reference S-ECG) .......................................................................... 62(Capture All Sense Vectors) ...................................................... 63
(Beeper Control) ..................................................................................................... 63(Reset Beeper)........................................................................................................ 64
(Enable/Disable Beeper) ................................................................ 65(Manual Setup) ................................................................................................................. 65
SMART (SMART Settings) ...................................................................................................................... 67SMART (SMART Charge) .......................................................................................................... 67SMART (Disabling SMART Pass) ................................................................................. 68
AF (AF Monitor) ................................................................................................................................. 69
(Additional Programmer Functions) ............................................. 69
(Rescue Shock) .............................................................................................................. 69(Manual Shock) ............................................................................................................. 71
S-ICD (S-ICD System Magnet Use) ........................................................... 71
(MAINTENANCE)
(Charging the Programmer) ..................................................................................... 73(Cleaning the Programmer) ...................................................................................... 73
(Service)...................................................................................................................................................... 73(Maintenance Check) .............................................................................................. 74
(Safety Measurements) ............................................................................................................... 74(Programmer End of Life) ................................................................. 74
(TROUBLESHOOTING)
(Inability to Print) .......................................................................................................................... 75(No Printer Available)....................................................................................... 75
AC (Touch Screen Inactive while Connected to AC Power) ....... 75(Loss of Communication with Printer) .......................................................... 75
(Inability to Communicate With the Pulse Generator) ....... 76
(COMPLIANCE STATEMENTS)
EMI/RFI (EMI/RFI) .............................................................................................................................................. 77(Essential Performance) .............................................................................................................. 77
1999/5/EC (R&TTE ) (1999/5/EC (R&TTE Directive)) ..................................................................... 77
(DECLARATIONS TABLES)
.................................................................................................................... 781 ........................................................................................................ 782 ........................................................................................................ 79
................................................................................................................................................... 80EMI/RFI .................................................................... 80EMI/RFI Bluetooth™ .................................................. 80
(SPECIFICATIONS)
............................................................................................................................................... 81 ....................................................................................................................................................................... 81
( ) ......................................................................................................................... 82
(DEFINITION OF PACKAGE LABEL SYMBOLS)
( 3200).................................................................................. 83
A: microSD™ ........................................................................... 85
1
S-ICD :
(Description)
S-ICD ( ) (S-ICD ) 1S-ICD
S-ICD S-ICD
(GUI)AC
RF S-ICDS-ICD
S-ICD S-ICD
(Intended Use of Programmer)
(Indications for Use)
S-ICD
(Contraindications)
S-ICD
2
S-ICD :
(Related Information)
S-ICD
• EMBLEM S-ICD, EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator User’s Manual ( S-ICD )
• S-ICD ( )
• S-ICD ( )
MRI MRI S-ICD MRI MRI TECHNICAL GUIDE ( MRI )
(Programmer Warnings and Precautions)
S-ICD ( 3200)
(Programmer Warnings)
(General)
•
• MR Unsafe MR Unsafe MRMRI III ( ) 1
MRI MRI III IV
1 Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
3
S-ICD :
• -10°C 55°C (14°F 131°F)
• 100°C (212° F)
•
(Conditions for Operation)
•
•
•
•
• 402 405MHz 2.4GHz
• ( 402405MHz 2.4GHz)
(CISPR)RF
" (Troubleshooting)"
4
S-ICD :
•
IEC/EN 60601-1Clause 16
•
(Programmer Precautions)
(General)
• ( 3203)•
•
•
• Bluetooth™ Bluetooth™
(Storage and Handling)
• ( )
•
•
Bluetooth™ Bluetooth SIG, Inc.
microSD™ SD-3C, LLC.
5
S-ICD :
• microSD™
(Implantation)
•
•
(Conditions for operation)
• AC
• AC
•
• S-ICD
• (ESD) ESD ESD
ESD
S-ICD (S-ICD System Warnings and Precautions)
S-ICD
( )
6
S-ICD :
S-ICD (S-ICD System Warnings)
(General)
• S-ICD S-ICDS-ICD
•
CPR
•
S-ICD
(Post-Implant)
• S-ICD
• ()
• S-ICDS-ICD
• (MRI) EMBLEM S-ICD ( A209A219) MR Conditional MRI
MRI MR Conditional
MR Conditional MR Conditional MRI
7
S-ICD :
•
• EMI 80 V
16.6Hz
(Clinical Considerations)
• S-ICD
• S-ICD• S-ICD (CRT)
(ATP)
(Implantation)
•
Shelf ( ) Therapy Off ( )
(Device Programming)
•
•
• (SVT) SVTSVT
8
S-ICD :
S-ICD (S-ICD System Precautions)
(Environmental and Medical Therapy Hazards)
• (EMI)
EMIEMI EMI
EMI1
»
»
» TENS
» ( EKG )
(Hospital and Medical Environments)
•
»
»
» (" " )
• (CPR)
• ( )
(VAD)
9
S-ICD :
•
»
»
(" " )
1 1
(1 )
10
S-ICD :
• (RF) RF
RF
»
»
»
»
» RF
(" " )
• (ESWL)ESWL
»
»
• ( )
( )
•
(TENS)
("" )
11
S-ICD :
• (TENS) TENSTENS TENS
» TENS
» TENS
» TENS TENS
» TENS
TENS
( ) TENS
» TENS
» TENS
» TENS TENSTENS
1.
2. TENS ( ) S-ECG
3. TENS
TENS(" " )
12
S-ICD :
• (EAS) (RFID)
• (HBOT)(ISO) HBOT
HBOT
HBOT("
" )
(Follow-up Testing)
•
25
25
•
(DFT)
13
S-ICD :
•
(Explant and Disposal)
•
»
» ( )
»
(Supplemental Precautionary Information)
•
»
» S-ECG
»
»
»
»
»
14
S-ICD :
(Potential Adverse Events)
S-ICD ()
•
•
•
•
•
•
•
•
•
•
•
• ( )
•
•
•
•
•
•
•
•
•
•
•
•
15
S-ICD :
•
•
•
•
•
•
•
•
•
•
•
S-ICD
S-ICD ()
•
•
•
•
16
S-ICD : (OPERATION)
(Programmer Setup)
(Packaging)
• ( 3200)
• ( 3203)
• AC ( 3204)
(Programmer Controls and Connections)
microSD™
1:
17
S-ICD : (OPERATION)
(Charging the Programmer)
ACAC
: 45 AC
5
• 4 ( ) - 100%
• 3 ( ) - 75%
• 2 ( ) - 50%
• 1 ( ) - 25%
• Programmer Battery Low ( )
• Programmer Battery Critical ( )
• Out Of Power ( )
1. ( 1)
18
S-ICD : (OPERATION)
2. AC
:
:
: 230VAC AC
(Using the Programmer)
(Turning the Programmer On)
( 1)
: AC
AC
(Changing the Programmer Volume Level)
( 1)
(Placing the Programmer in Suspend Mode)
•
• S-ICD15
19
S-ICD : (OPERATION)
(Turning the Programmer Off)
2
1.Power off ( ) OK
2. Power Off OK
(Using the Programmer Touch Screen)
LCD
:
(Using the Wand)
3203 ( )
: ( 3203)
:
:
( 1)
20
S-ICD : (OPERATION)
:
: ( 402 405MHz 2.4GHz)
(CISPR)RF
" (Troubleshooting)"
Communication Loss ( )
:
(Navigation)
(GUI) S-ICD
( ) (S-ECG)
21
S-ICD : (OPERATION)
(Screen Header)
( )
•
•
•
( )
•
•
•
•
•
• Rescue shock ( )
(Navigation Bar)
1
(Restarting the Programmer)
•
•
22
S-ICD : (OPERATION)
OK
23
S-ICD : (OPERATION)
1:
Main Menu ( ) Main Menu
Automatic Setup ( ) Automatic Setup
Device Settings ( ) S-ICD Device Settings
Device Status ( ) (
)
S-ICD Device Status
S-ICD
Patient View ( )S-ICD
S-ECG S-ECG
Induction Test ( )
Manual Shock ( ) Manual Shock
S-ECG S-ECG
S-ECG Display Settings (S-ECG )S-ECG
Rescue Shock ( )
Option Selection Switch ( ) 2 (A B) 1
24
S-ICD : (OPERATION)
(Configuring the Programmer)
(Configuring Programmer Settings)
1. ( 2) Programmer Settings ( ) Programmer Settings ( 3)
2:
25
S-ICD : (OPERATION)
3: Programmer Settings
2.
•
•
•
•
(Date and Time Format)
1. Programmer Settings ( ) Set Date and Time Format () ( 3) Date and Time Settings ( )
2.
3. Save ( ) Programmer Settings Cancel ( )Programmer Settings
26
S-ICD : (OPERATION)
(Time Zone)
( )( (EMI) ) 2
S-ICD
50Hz 60Hz
1. Programmer Settings ( ) Set Time Zone ( )( 4)
2.
3. Save ( ) Programmer Settings Cancel () Programmer Settings
1 2
()
27
S-ICD : (OPERATION)
4: ( )
(Language Preference)
1. Programmer Settings ( ) Set Language ( )Language Settings ( )
2. Save ( ) Cancel ( )Programmer Settings
(Printer Selection)
Bluetooth™
1.USB
28
S-ICD : (OPERATION)
2. Programmer Settings ( ) Printer Setup ( )Printer Setup ( ) ( 5)
5: Printer Setup
3.Scan Again ( )
Cancel ( ) Programmer Settings ( )
4. (15 ) ID
5. Save ( ) Programmer Settings Cancel () Programmer Settings
: " (Troubleshooting)"
29
S-ICD : (OPERATION)
(Programmer Software Version)
1. Programmer Settings ( ) About Programmer ( )Programmer Software Version ( )
2. Programmer Software VersionContinue ( ) Programmer Settings
:
Bluetooth™ (Bluetooth™ Data Export)
Bluetooth™
: Windows
1.
: Microsoft Windows Bluetooth
2. Export Programmer Data ( ) Export Programmer Data Over Bluetooth ( Bluetooth ) Set Up Authorized Computers ( )
3. (Bluetooth™ 3 )Unauthorized Computers Nearby (
) ( 6)
30
S-ICD : (OPERATION)
4.2
5. Unauthorized Computers Nearby Authorized Computers ( )
6. Rename an Authorized Computer ( )
6: Bluetooth™
31
S-ICD : (OPERATION)
(Programmer Modes of Operation)
(Online Behavior)
( )( )
5
Rescue Shocks ( )
1
: ( )
(Offline Behavior)
Programmer Settings ( )
(Stored Patient Sessions)
50 51
• S-ECG ( S-ECG )• ( )• •
32
S-ICD : (OPERATION)
(To view stored patient sessions:)
1. Stored Patient Sessions ( )
2.
(Modes of Operation for the Pulse Generator)
• Shelf ( )
• Therapy On ( )
• Therapy Off ( )
• MRI Protection Mode (MRI )
Shelf ( ) (Shelf Mode)
Shelf ShelfShelf
Therapy Off ( )Shelf
Shelf
Therapy On ( ) (Therapy On Mode)
Therapy On
33
S-ICD : (OPERATION)
Therapy Off ( ) (Therapy Off Mode)
Therapy Off
(S-ECG)
Shelf Therapy Off
: Therapy OnTherapy Off
" (Automatic Setup)"
MRI Protection (MRI ) (MRI Protection Mode)
MRI Protection S-ICD
MRI Protection S-ICD MRIMRI Protection MR
Conditional MRIMRI Protection
MRI Protection MR Conditional S-ICDMRI
MRI S-ICD MRI ProtectionMRI Protection
•
• Time-out ( ) 6 6 912 24
•
MRI Protection Time-out (MRI )MRI Protection (MRI Protection
MRI )MRI Protection MRI Protection
( )
: MRI Protection
34
S-ICD : (OPERATION)
S-ICD (Connecting and Disconnecting from
the S-ICD Pulse Generator)
: S-ICD S-ICD
(Scanning for Pulse Generators)
1. Scan For Devices ( )( 2) Device List (
) Cancel ( )
2. ( 16 )Device List ( 7) Shelf ( ) Not Implanted (
) Shelf Implanted ()
7: ( )
35
S-ICD : (OPERATION)
3. Scan Again ( )Cancel
: " (Troubleshooting)" "(Inability to Communicate With the Pulse Generator)"
(Connecting to a Pulse Generator)
Device List ( ) ( 7)
:
Shelf ( ) (Connecting to a Pulse Generator inShelf Mode)
1.
2. Device Identification ( ID)
: ID Shelf ( )
3.Continue ( ) Shelf
Cancel ( ) Device List ( )
(Connecting to an Implanted Pulse Generator)
Device List ( )
1.
2. Device Status ( )( 16)
36
S-ICD : (OPERATION)
(Ending a Patient Session)
1. Main Menu ( ) Main Menu ()
2. End Session ( ) ( 8)
8: Main Menu
3. ( 9)
•
• Reference S-ECG ( S-ECG)
• Automatic or Manual Setup ( )
• Optimization ( ) Automatic Setup () Setup Optimization ( )
37
S-ICD : (OPERATION)
9:
4. Continue ( )Cancel ( ) Main Menu
: Continue
: 1 4End Session
: End Session
38
S-ICD : (OPERATION)
(Programming the Pulse Generator at
Implant)
: ( 3203)
:
:
: S-ICD
(Entering Electrode Information)
1. Main Menu ( )
2. Implant ( )
3. Automatic Setup ( )( 12)
4. Set Electrode ID ( ID )
39
S-ICD : (OPERATION)
10: Set Electrode ID
: ECGAutomatic Setup Electrode ID setup ( ID )
5.
6. Program ( )Automatic Setup Cancel ( )
(Creating the Patient Chart)
1. Main Menu ( )
2. Implant ( )
3. Patient View ( ) Patient View ( 11)
4. 12 3
• Patient Name ( ): 25
• Doctor Name ( ): 25
40
S-ICD : (OPERATION)
• Doctor Info ( ): 25
• Notes ( ): 100
11: Patient View
: Notes 1
5. Save ( )
:
(Automatic Setup)
S-ICD Automatic Setup ( )
Automatic Setup
1. Main Menu ( )
2. Implant ( )
41
S-ICD : (OPERATION)
3. Automatic Setup ( ) Automatic Setup Automatic Setup ( )
4. 130min-1 Continue ( ) ( 12)130min-1 Cancel ( ) (Manual Setup)
12: Automatic Setup
5. Automatic Setup
• (Sub-threshold) 400
• ECGSMART Pass (SMART )
Manual Setup ( )SMART Pass (On/Off) SMART Settings programmer (SMART) Summary Report ( ) (SMART
Charge (SMART ) SMART Pass "SMART (SMART Settings)" )
• Manual Setup
42
S-ICD : (OPERATION)
13:
Automatic Setup ( 13)
6. Automatic SetupAutomatic Setup
Skip ( )Automatic Setup
7. Automatic Setup Continue ( ) Automatic Setup
8. Acquire Reference S-ECG ( S-ECG )Continue ( ) S-ECG
9. S-ECG1
QRS Cancel () S-ECG
Continue ( )
43
S-ICD : (OPERATION)
(Programming Therapy Parameters)
Automatic Setup ( )
1. Main Menu ( )
2. Implant ( )
3. Device Settings ( ) Device Settings ( 14)
14: Device Settings
4. Therapy: ON/OFF ( )
5. Conditional Shock ( ) ( ) Shock ( ) ( )
: 1 S-ICD1
1 Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee Kl, Smith W, Burke MC.Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128:944–953
44
S-ICD : (OPERATION)
• Shock 10min-1 170 250min-1
• Conditional Shock 10min-1 170 240min-1
Conditional Shock
• Shock Conditional Shock 2 10min-1 Conditional Shock
( ) Shock ( ) 21 Shock
6. Post Shock Pacing ( )( 50min-1
30 50min-1 )
7. Program ( )
Continue ( ) Device Settings ( )
8. Device SettingsContinue
: ( 402 405MHz 2.4GHz)
(CISPR)RF
" (Troubleshooting)"
9. Continue ( )
: Device Settings ( )Pending Program Changes (
) Cancel ( ) Device Settings Continue
45
S-ICD : (OPERATION)
(Defibrillation Testing)
: CPR
:
(DFT)
: VF S-ICD
: Hold to Induce ( ( ))
("S-ECG (Capturing and viewing S-ECG Strips)" "S-ECG (Captured S-ECG Report)" )
VF S-ICD
1. Main Menu ( ) Main Menu
2. Patient Test ( ) ( 15)
3. STD ( ) REV ( )
4.10 80J 15J
46
S-ICD : (OPERATION)
15:
5. Continue ( ) Induction Test Cancel ( )Main Menu
: S-ECG ( N )
6. Hold To Induce ( ( ))
• S-ICD 50Hz 200mA (AC)Hold To Induce (1 10 )
:
• S-ECG Hold to Induce
47
S-ICD : (OPERATION)
• S-ICD
: (
)
• 1(80J)
: Hold To InduceS-ICD T
: 1 580J Rescue Shock (
)
• Hold to Induce S-ECGCaptured S-ECG ( S-ECG) Hold to Induce 6
102 108 Induction S-ECGs (S-ECG) S-ECG S-ECG
7. Abort ( )
8. Exit ( ) Main Menu
48
S-ICD : (OPERATION)
(Performing a Follow-up)
(Sensing Configuration and Automatic Setup)
Automatic Setup ( )
S-ECGQRS S
Manual Setup ( )
:
: Automatic Setup
ECG S-ECG Acquire Reference S-ECG ( S-ECG )
(Viewing Pulse Generator Status)
Device Status ( )
1. Main Menu ( )
2. Follow Up ( )
3. Device Status ( ) Device Status
4. Device Status ( 16)
49
S-ICD : (OPERATION)
16: Device Status
•
•
•
•
• AF
: Episodes ( ) View ( )( 17)
•
(Viewing Stored Episodes)
S-ICD ( A209) 2520 MRI S-ICD ( A219) S-ECG
20 15 AF 7
50
S-ICD : (OPERATION)
:
1. Main Menu ( )
2. Follow Up ( )
3. Captured and Stored Episodes S-ECG ( S-ECG)
4. Episodes Episodes ( 17)
5.
: Episodes
17: Episodes ( )
6.S-ECG
51
S-ICD : (OPERATION)
7. Continue ( ) Episodes
128 S-ECG
• S-ECG: 44
• : 24 S-ECG 12 S-ECG
• : 6 S-ECG 6 S-ECG
Untreated Episode ( )
Untreated Episode 1 128 S-ECG
• S-ECG: 44 S-ECG
• S-ECG: 84 S-ECG
(Printing Reports from the Programmer)
(Printing Reports)
3
• Summary Report ( )
• Captured S-ECG Report ( S-ECG )
• Episode Reports ( )
1. Main Menu ( ) Main Menu
52
S-ICD : (OPERATION)
2. Print Reports ( ) Print Reports ( 18)
18: Print Reports
3.
4. Print ( )
5. Cancel ( )
(Summary Report)
Print Reports ( ) Summary Report () Print ( ) (
) ( )
•
• (Programmer Software Version)
•
•
53
S-ICD : (OPERATION)
•
•
•
•
•
•
• SMART
• SMART (On/Off)
•
• ( )
•
• AF
• AF
• ( )
• MRI
• :
•
•
S-ECG (Captured S-ECG Report)
Captured S-ECG ( S-ECG)
1. Print Reports ( ) Captured S-ECG Report ( S-ECG )
2. Captured S-ECG ( S-ECG) Induction S-ECG ( S-ECG)( 19) S-ECG
54
S-ICD : (OPERATION)
19: S-ECG ( )
3. Continue ( ) Print Reports
4. Print ( )
5. Cancel ( )
(Episode Reports)
1. Print Reports ( ) Episode Reports ( )
2. Select Episode Reports ( )( 20)
: Episodes ( )( 17)
55
S-ICD : (OPERATION)
20: Select Episode Reports ( )
3. Continue ( ) Print Reports Episode Reports12 44 S-ECG
Episode Report Onset ( ) 12
4. Print ( )
5. Cancel ( )
(Export Patient Data)
21 Bluetooth™
1 3205 microSD™ Bluetooth™
"Bluetooth™ "
Bluetooth™ (Export using Bluetooth™ wireless technology)
Bluetooth™ 10m (33 )
56
S-ICD : (OPERATION)
1. Export Programmer Data () Export Programmer Data Over Bluetooth ( Bluetooth
)
2. 3 (Export Today’s Data ( ) Export Last Seven Days ( 7 ) Export All (
)) 1 Select a receiving computer ( )
: Export Today’s Data Export Last Seven Days Export All
3.
: 10m (33 )3 1
10m 10mExport Programmer Data Over Bluetooth
( Bluetooth ) 31
microSD™ (Export using a microSD™ card)
microSD™ 3205 microSD™
microSD™ ( )
1.
2. A: microSD™ microSD™ 3205 microSD™
microSD™ Copy Data ( )
: 3205 microSD™ 3205
OK
57
S-ICD : (OPERATION)
3. Copy Data
4. OK
5. ( A) microSD™
: microSD™
S-ECG (S-ECG Features)
S-ECG
S-ECG (S-ECG Rhythm Strip Markers)
S-ECG "S-ECG "( 2)
58
S-ICD : (OPERATION)
2: S-ECG
a C
S
N
P
T
•
NSR a
a
S-ECG (S-ECG Scale Settings)
S-ECG
1. S-ECG S-ECG Display Settings (S-ECG )S-ECG Setting (S-ECG )
2. ( 21) S-ECG
1x2x 1/2
S-ECG25mm/
59
S-ICD : (OPERATION)
: S-ECG S-ECG
21:
S-ECG (Capturing and viewing S-ECG Strips)
S-ECG15
1. S-ECG 12 S-ECG
• S-ECG 8.5
• S-ECG 3.5
60
S-ICD : (OPERATION)
2. S-ECG
• 6
• 102
: 1.6 S-ICD1.6 S-ECG
15
S-ECG (To manually capture a new S-ECG rhythm strip:)
1. S-ECG S-ECG S-ECGCaptured S-ECG ( S-ECG)
12
: Induction S-ECG ( S-ECG)
2. S-ECG
3. Continue ( )
Utilities ( ) Capture All Sense Vectors ( )3 (Primary ( ) Secondary ( )
Alternate ( )) S-ECG ( 22)
S-ECG (Viewing previously-captured S-ECGs)
1. Main Menu ( )
2. Follow Up ( )
3. Captured and Stored Episode S-ECG ( S-ECG )Captured S-ECG ( S-ECG)
4. S-ECG Induction S-ECG ( S-ECG) 1 S-ECG
61
S-ICD : (OPERATION)
5.
6. Captured S-ECG Continue ( )
1. Main Menu ( ) Stored Patient Sessions ( )
2.
3. Captured S-ECG ( S-ECG) 1 Captured S-ECG Details (S-ECG )
: S-ECGS-ECG
Main MenuEnd Session ( )
4.
5. Captured S-ECG Continue ( )
62
S-ICD : (OPERATION)
(Utilities Menu)
Utilities ( )Acquire Reference S-ECG ( S-ECG ) Capture All Sense Vectors (
) Beeper Control ( ) Manual Setup ( )SMART Settings (SMART ) AF Monitor (AF )
Utilities
1. Main Menu ( ) Main Menu
2. Utilities Utilities ( 22)
22: Utilities
S-ECG (Acquire Reference S-ECG)
Reference S-ECG ( S-ECG)
1. Utilities ( ) (Main Menu ( ) ) Acquire Reference S-ECG ( S-ECG ) Acquire Reference S-ECG
63
S-ICD : (OPERATION)
2. Continue ( ) Reference S-ECG Reference S-ECG
S-ECG QRS
3. Continue Utilities Cancel ( )S-ECG Utilities
(Capture All Sense Vectors)
Utilities ( ) Capture All Sense Vectors ( ) 3(Primary ( ) Secondary ( ) Alternate (
)) S-ECG1 S-ECG
3
1. Utilities (Main Menu ( ) ) Capture All Sense Vectors
2. Capturing 12 Second S-ECG (S-ECG (12 ))
" S-ECG (Viewing previously-captured S-ECGs)"3 S-ECG
(Beeper Control)
( )
•
•
•
•
64
S-ICD : (OPERATION)
9 16
:
: Reset Beeper ( )
: MRI MRIMR
MRI Protection MRIMR
MRI LATITUDE NXT () 3 1
(Reset Beeper)
Utilities ( ) (Main Menu ( )) Beeper Control ( ) Set Beeper Function (
)
Reset Beeper ( )S-ICD
65
S-ICD : (OPERATION)
(Enable/Disable Beeper)
S-ICD
: S-ICD Test Beeper ( )
1. Utilities ( ) Beeper Control ( )
2. Set Beeper Function ( ) Test Beeper ( )
3.
4. Yes, Enable BeeperNo, Disable Beeper
:
3 1 LATITUDE NXT
MRI
(Manual Setup)
Manual Setup ( )
SMART Pass (SMART ) ( )
1. Utilities ( ) (Main Menu ( ) ) Manual Setup Measure Impedance ( )
66
S-ICD : (OPERATION)
2. Test ( )
3. Continue
4. Manual Setup 3 ( 23)
• Primary ( ):
• Secondary ( ):
• Alternate ( ):
S-ECG Select Gain ( )
23: ( )
• 1x ( 4mV): 2x1x
• 2x ( 2mV):2x 2x
1x 2
67
S-ICD : (OPERATION)
1. Program ( )
2. Continue ( ) Continue SMART Pass (SMART )SMART Pass S-ICD
3. Acquire Reference S-ECG ( S-ECG )Continue ( ) S-ECG
S-ECG
SMART (SMART Settings)
SMART Settings (SMART ) SMART Charge (SMART )SMART Pass
SMART (SMART Charge)
SMART Charge (SMART )
SMART Charge
SMART ChargeSMART Charge SMART Charge
1. Utilities ( ) (Main Menu ( ) ) SMART Settings (SMART ) SMART Settings ( 24)
68
S-ICD : (OPERATION)
24: SMART Settings
2. Reset ( ) SMART Charge Cancel ( )SMART Charge Utilities
3. SMART Charge successfully reset. (SMART )
4. Continue ( ) Utilities
SMART (Disabling SMART Pass)
SMART Pass (SMART )ECG
SMART Pass
SMART Settings Disable ( )SMART Pass
: SMART Pass
69
S-ICD : (OPERATION)
AF (AF Monitor)
AF Monitor (AF )
Utilities ( ) AF Monitor On/Off AF Monitor/ Program ( )
AF Monitor
• AF 90 AF
• AF 90 AF
AF Monitor S-ICD
(Additional Programmer Functions)
(Rescue Shock)
Setup ( )Rescue Shock ( )
(80J)
1. Rescue Shock Rescue Shock( 25)
70
S-ICD : (OPERATION)
25: Rescue Shock
2. Shock ( )Charging ( ...) Abort ( )
Device Settings ( )
3.
: 25
25
The shock could not be delivered. ()
: Rescue Shocks
71
S-ICD : (OPERATION)
(Manual Shock)
Manual Shock ( )10 80J
( 26)
Manual Shock ( ) Patient Test () Induction Test ( )
Manual Shock ( ) Manual Shock Test ( )
26:
S-ICD (S-ICD System Magnet Use)
( 6860 4520)
Cameron Health ( 4520)
S-ICD
72
S-ICD : (OPERATION)
•
•
•
• QRS 60 ()
: S-ICD
: ()
:
: Rescue Shock ( )
Rescue Shock
:
73
S-ICD : (MAINTENANCE)
(MAINTENANCE)
(Charging the Programmer)
AC AC
(Cleaning the Programmer)
1.
2.
3.
4.
(Service)
74
S-ICD : (MAINTENANCE)
(Maintenance Check)
•
•
• ()
(Safety Measurements)
IEC/EN 62353IEC/EN 62353 24
( 11)
(Programmer End of Life)
75
S-ICD : (TROUBLESHOOTING)
(TROUBLESHOOTING)
(Inability to Print)
1.
2.
3. Bluetooth™ USB
(No Printer Available)
No Printer Available ( )Try Again ( ) " (Printer Selection)"
AC (Touch Screen Inactive while Connected to AC Power)
AC
(Loss of Communication with Printer)
Error while printing reports. Press 'Continue' to try printing any remaining reports, or 'Cancel' to cancel the current print job. ( Continue ( )
Cancel ( ))
76
S-ICD : (TROUBLESHOOTING)
1. Try Again ( )
2. Bluetooth™ USB
3.
4. RF
(Inability to Communicate With the Pulse Generator)
1.
2. Scan For Devices ( )Device List ( ) Scan Again ( )
3. RF
4. S-ICD
5.
77
S-ICD : (COMPLIANCE STATEMENTS)
EMI/RFI (EMI/RFI)
IEC 60601-1-2:2007 90/385/EEC
• • •
•
(Essential Performance)
( 3200) S-ICD
1999/5/EC (R&TTE ) (1999/5/EC (R&TTE Directive))
S-ICD 402 405MHz 2402 2480MHz Bluetooth
Directive 1999/5/EC
:
(COMPLIANCE STATEMENTS)
78
S-ICD : (DECLARATIONS TABLES)
4: 1
3:
( 3200) ( 3200)
RF CISPR 11 1 ( 3200)
RF RF
RF CISPR 11 A ( 3200)
IEC 61000-3-2 A
IEC 61000-3-3
( 3200) 3200
IEC 60601
(ESD)
IEC 61000-4-2
6kV
8kV
6kV
8kV
30%
IEC 61000-4-4
2kV
1kV
2kV
1kV
IEC 61000-4-5
1kV -
2kV -
1kV -
2kV -
IEC 61000-4-11
0.5 <5% UT (>95% UT
)
5 40% UT (60% UT
)
25 70% UT (30% UT
)
5 <5% UT (>95% UT )
0.5 <5% UT (>95% UT
)
5 40% UT (60% UT
)
25 70% UT (30% UT
)
5 <5% UT (>95% UT )
( 3200)
(50/60Hz)
IEC 61000-4-8
3A/m 3A/m
: UT AC
79
S-ICD : (DECLARATIONS TABLES)
5: 2( 3200) ( 3200)
IEC 60601
RF
IEC 61000-4-6
3Vrms
150kHz
80MHz
3V RF
( 3200)
3.5 √ Pd = [ ]3.5 √ Pd = [ ]7 √ Pd = [ ]
80MHz 800MHz
800MHz 2.5GHz
150KHz 80MHz
P (W)
d (m)
a RFb
RF
IEC 61000-4-3
3V/m
80MHz
2.5GHz
3V/m
1: 80MHz 800MHz
2:
a ( ) AM/FM TV
RF
( 3200)
RF ( 3200)
( 3200)
b 150kHz 80MHz 3V/m
V1
E1
E1
80
S-ICD : (DECLARATIONS TABLES)
6:
RF ( 3200)
RF
RF ( )
W
m
150KHz 80MHz 3.5V1
d = [ ]√ P80MHz 800MHz
3.5E1
d = [ ]√ P800MHz 2.5GHz
7E1
d = [ ]√ P0.01 0.117 0.117 0.233
0.1 0.369 0.369 0.738
1 1.17 1.17 2.34
10 3.69 3.69 7.38
100 11.7 11.7 23.3
(m)
d p (W)
1: 80MHz 800MHz
2:
7: EMI/RFI :
(MICS)
402 405MHz
FSK
<25μW
< 300KHz
8: EMI/RFI : Bluetooth™
Bluetooth™
2.402 2.480GHz
GFSK /4-DQPSK 8DPSK
<10mW
< 1.5MHz
81
S-ICD : (SPECIFICATIONS)
9:
DC
4000mAh 3.7V
5
100 240VAC 50 60Hz 0.5A
5.5VDC 3.64A
:20W
Elpac Power Systems MWA020005A
15°C +38°C
(+59°F +100°F)
-10°C +55°C
(+14°F +131°F)
40°C 5% 93% 40°C 5% 93%
50kPa 106kPa
(7.252psi 15.374psi)
50kPa 106kPa
(7.252psi 15.374psi)
10:
x x
24.0cm x 12.7cm x 2.6cm
(9.4in x 5.0in x 1.0in)
0.6kg 1.3lbs
WVGA 1024 x 600 16M TFT
82
S-ICD : (SPECIFICATIONS)
11: ( )
– IEC 60601-1:2005/ANSI/AAMI ES60601-1:2005
5mA ( (NC))
10mA ( (SFC))
100μA ( (NC))
500μA ( (SFC)) ( )
– IEC 62353:2008
500μA
( BF)<= 5000μA
5000V 400J
83
S-ICD : (DEFINITION OF PACKAGE LABEL SYMBOLS)
12: : ( 3200)
( 3200)
www.bo
stonsc ien t i f i c -elabeli ng.com
BF
ACMA
microSD™
WEEE (WEEE)
(
) IDCE
84
S-ICD : (DEFINITION OF PACKAGE LABEL SYMBOLS)
( 3200)
R-NZ RF MR Unsafe
mic
roS
Dスロットのカバー
を持ち上げ回転させる。ス
ロット内にカードがないこ
とを確認する。
カードに文字が記載されてい
る面をプログラマ画面と同じ
方向に向けて空のスロット内
にm
icro
SDカードを挿入する。
カードのラッチが所定の位置に収
まるまでスロット内にカードを静
かに押し込む。スプリングテン
ショナに押し戻される力を強く感
じるようになった後、小さなカ
チッという音が聞こえたら、ラッ
チがロックされた状態である。
カードが適切に挿入されてい
る場合はスロットの開口部面と
カード端が揃っている。
mic
roS
Dスロットのカバー
を閉じる。
mic
roS
Dスロットのカバーを
持ち上げ回転させる。スロッ
ト内にカードがあることを確
認する。
ラッチが解除されてカチッとい
う音が聞こえるまで指先でカー
ドの端を押す。もう一度カチッ
という音が聞こえるまでカード
がゆっくり出てきたら、指を離す。
この状態になったら、カード
を安全に取り外すことができ
るが、カードを指でつかむの
が難しい場合もある。その場
合はスロット内のスプリング
テンショナの力を使ってカー
ドを外に出すことができる。
指先でスロット内にカードを少
し押し戻し、カードのラッチが
所定の位置に戻る前に、指をす
ばやく後ろに離す。カードはあ
る程度遠くまで飛び出すことが
あるため注意すること。
カードが出てくるまでこの手順を
繰り返す。
mic
roS
Dスロットのカバー
を閉じる。
S-IC
Dプログラマ
(モデル
3200
)
microSDの挿入 microSDの取り外し85
A: microSD™ (INSERTION AND REMOVAL OF THE microSD™ CARD)
359465-001 en Europe 2015-10
S-ICD 3200
