rhythmia hdx - boston scientific- us · 2 rhythmia hdx™ g]g gwg4g5g0 v 1 Â i 1.2.2 2 ' ø...
TRANSCRIPT
![Page 1: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/1.jpg)
RHYTHMIA HDx™
92022381-01AEPT-022
2017-06
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RHYTHMIA HDx™ i
1. RHYTHMIA HDX™ (DEVICE DESCRIPTION) . . . . . . . . . . 1
1.1 (Operating Principle) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1.1 (Continuous Mapping) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1.2 (Catheter Localization and Tracking) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 (System Components) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.1 (Signal Station). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.2 (System Software) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.3 (Workstation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.4 (Accessories) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.5 (Intended Applied Parts) . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 (User Information) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4 (Intended Use) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.5 (Indications for Use) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.6 (Contraindications) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. (WARNINGS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3. (CAUTIONS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.1 (General) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.2 (Signal Station) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.3 (Intended Applied Parts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.4 (Workstation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.5 (Cables) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.6 (Electrical) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.7 (Body Surface Electrodes) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.8 (Environmental) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.9 (Magnetic Localization System) . . . . . . . . . . . . . . . . . . 7
3.10 (Cleaning and Disinfecting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.11 (Repair or Replacement) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.12 (Disposal) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4. (POTENTIAL ADVERSE EVENTS) . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.1 (Arrhythmias) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2 (Misinterpretation of Data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5. (CONFORMANCE TO STANDARDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
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ii RHYTHMIA HDx™
6. (HOW SUPPLIED). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7. (OPERATING INSTRUCTIONS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.1 (Setup and Installation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.2 (Major Hardware Components) . . . . . . . . . . . . . . . . . . . . . . . . 11
7.3 (Signal Station) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.4 SiS (SiS Front Panel Description) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.5 SiS (SiS Front Panel Inputs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.5.1 IntellaMap Orion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.5.2 (Breakout Box) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.5.3 ECG (ECG Input Cables). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.5.4 (Ablation Connection Box) . . . . . . . . . . . . . . . 16
7.5.5 (Stimulator Jumper Cables) . . . . . . . . . . . 17
7.5.6 (Location Reference Back Patch) . . . . . . 18
7.6 SiS (SiS Front Panel Outputs). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.6.1 (Direct Connect IC Cables) . . . . . . . . . . . . . . . . . . . . . 18
7.6.2 ECG (Direct Connect ECG Cables) . . . . . . . . . . . . . . 19
7.6.3 (Rhythmia IC Out 72 Cable) . . . . . . . . . . . . . . . . . . . . . . . 19
7.6.4 ECG (ECG Output Box) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.7 SiS (SiS Rear Panel Description) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
7.8 SiS (SiS Rear Panel Connections) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.8.1 (Localization Generator Input Port). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.8.2 (Workstation Data Connection) . . . . . . . . . . . . . . . . . . . . 23
7.8.3 (Foot Switch) ( ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.8.4 (Electric Power Input). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
7.9 (Workstation Description) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
7.10 (Workstation System Requirements). . . . . . . . . . . . 24
7.11 (Workstation Setup) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
8. (PREPARING FOR A MAPPING STUDY) . . . . . . . . . . . . . . . . . . . . . . . 25
8.1 (Prior to Patient Arrival) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8.1.1 (Setup the Hardware and Make the Cable Connections) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
8.1.2 (Prepare the Workstation) . . . . . . . . . . . . . . . . . . . . . . . 26
8.2 (Upon Patient Arrival) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
8.2.1 (Make Required Cable and Catheter Connections). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
8.2.2 IntellaMap Orion (Additional Connections When Using One of the IntellaMap Orion Family of Catheters) . . . . . . . . . . . . . . . . . . 26
8.3 (Important Considerations During a Study) . . . . . . . . . . . 26
8.4 (Ending the Study). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
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RHYTHMIA HDx™ iii
9. (INDIVIDUAL CABLES ASSOCIATED WITH SYSTEM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
10. (DIRECT CONNECT CHANNEL MAPPING) . . . . . . . . . 30
11. INTELLAMAP ORION (PREPARING INTELLAMAP ORION FAMILY OF CATHETERS FOR USE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
12. (CLEANING GUIDELINES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
12.1 (Routine Cleaning and Disinfecting) . . . . . . . . . . . . . . 31
12.2 (Decontaminating the Equipment Before Shipping) . . .31
13 SiS (SIS TROUBLESHOOTING) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
14. (ELECTROMAGNETIC EMISSIONS AND IMMUNITY). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
15. (TECHNICAL SPECIFICATIONS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
16. (SERVICE INFORMATION) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
17. (CONTACTS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
18. RHYTHMIA HDX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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iv RHYTHMIA HDx™
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RHYTHMIA HDx™ 1
1. RHYTHMIA HDx™ (DEVICE DESCRIPTION)1.1 (Operating Principle)
RHYTHMIA HDx™ ( ) EP 3D3D
2 (a.) ECG
(continuous mapping) (b.)
1.1.1 (Continuous Mapping)
1.1.2 (Catheter Localization and Tracking)
(Magnetic-based localization)
(Impedance-based localization)
1.2 (System Components)1.2.1 (Signal Station)
(SiS) EP ECG
SiS
: ()
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2 RHYTHMIA HDx™
1.2.2 (System Software)RhythmiaSiS
• ECG• • 3D•
RHYTHMIA HDx™ (Software Directions for Use)
1.2.3 (Workstation)(
)
1.2.4 (Accessories)• SiS• ECG• • • • • • • • • • •
1.2.5 (Intended Applied Parts)
• IntellaMap Orion EP•
EP
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RHYTHMIA HDx™ 3
1.3 (User Information)
1.4 (Intended Use)EP 3D
SiS ()
1.5 (Indications for Use)
(ECG )
1.6 (Contraindications)
2. (WARNINGS)EP
•
• (RF)(
)
• ( )
•
• M A B ABL
1M A B
61 62ABL
1 2
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4 RHYTHMIA HDx™
• IntellaMap Orion
•
• IEC 60601-1
IEC 60601-1
• ( )
• Maestro™ EP-Shuttle
•
•
• ECG ( )
• ECGECG
ECG
•
• (CIED)20cm CIED
3. (Cautions)3.1 (General)
•
•
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RHYTHMIA HDx™ 5
• 2
• EMC 6 7 8
3.2 (Signal Station)•
(SiS) SiS
• SiS
• SiSSiS
• SiS
• SiS
• SiSSiS
• SiS SiS
• SiS
• SiS
• SiS SiS
3.3 (Intended Applied Parts)• IntellaNav™ XP IntellaNav™ MiFi XP
EP-Shuttle
3.4 (Workstation)•
•
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6 RHYTHMIA HDx™
3.5 (Cables)• ECG
ECG SiSECG
• SiS
•
•
•
15
3.6 (Electrical)•
3.7 (Body Surface Electrodes)•
•
• ECG
3.8 (Environmental)•
•
•
•
15
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RHYTHMIA HDx™ 7
3.9 (Magnetic Localization System)•
• 3cm 3cm
•
•
• SiS
•
•
• (CIED)
CIED
• CIED
3.10 (Cleaning and Disinfecting)•
•
•
•
•
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8 RHYTHMIA HDx™
• ECG
•
•
•
3.11 (Repair or Replacement)•
•
3.12 (Disposal)•
4. (POTENTIAL ADVERSE EVENTS)
4.1 (Arrhythmias)EP
EP RFRF
4.2 (Misinterpretation of Data)
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RHYTHMIA HDx™ 9
5. (CONFORMANCE TO STANDARDS)
• IEC 60601-1:2005+A1:2012 • IEC 60601-1-2:2007• IEC 60601-1-6:2010+A1:2013 • IEC 60601-2-27:2011 CORR 1:2012• IEC 62366:2007+A1:2014 • EN 55011:2009+A1:2010, Group 1,
Class A• CISPR 11:2009+A1:2010, Group 1, Class A
6. (HOW SUPPLIED)
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10 RHYTHMIA HDx™
![Page 17: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/17.jpg)
RHYTHMIA HDx™ 11
7. (OPERATING INSTRUCTIONS)7.1 (Setup and Installation)
7.2 (Major Hardware Components)2
• SiS ( EP )
• ( EP )
7.3 (Signal Station)(Function)
(SiS) ( 1) EP ECG
(3) SiS ECG
SiS
( 1)
1. SiS
![Page 18: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/18.jpg)
12 RHYTHMIA HDx™
7.4 SiS (SiS Front Panel Description)SiS ( 2
1) 2 1 5 6 7 8 9M A B 3
ECG B8
IntellaMap OrionM
( 3) M A BECG ( 4)
ECG
2. SiS
( 9) ( 11) SiSM A
B ECG ( 10) ECG( 12) ECG
ECG
SiS 1 2
![Page 19: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/19.jpg)
RHYTHMIA HDx™ 13
1: SiS
61 62
LEDSiS
LED 2SiS
1 2
1 M• IntellaMap Orion
•
2 A
3 B
4 ECGECG
ECG TRUNKSiS
5
6 MM :
IntellaMap Orion
7 A + ABLA
8 B B
9 ECG ECG ( 12)ECG
10 PATCH
11 CONDITION IntellaMap Orion
12
13 : IEC 60601
14
![Page 20: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/20.jpg)
14 RHYTHMIA HDx™
2: SiS LED
SiS SiS 2
SiS
1. SiS
2. LIVE
SiS
: LIVE
7.5 SiS (SiS Front Panel Inputs)7.5.1 IntellaMap Orion
IntellaMap Orion IN-M
( 11)
7.5.2 (Breakout Box)( 3) SiS
SiS2mm
( 64 ) 1 A1( )
1
M A BSiS
64 261( ) 62( ) M A B( ) SiS
61 62M A B
![Page 21: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/21.jpg)
RHYTHMIA HDx™ 15
3.
7.5.3 ECG (ECG Input Cables)ECG ( 4) 3 (TRUNK ) 2
(LIMB CHEST )ECG SiS
SiS IN-ECG SiS
4. ECG ( AAMI )
![Page 22: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/22.jpg)
16 RHYTHMIA HDx™
7.5.4 (Ablation Connection Box)
: Maestro™ EP-Shuttle
RF
• • • SiS ( 2 1 5)
2
5 6IntellaNav™ IntellaNav™
STANDARD CATHETER IntellaTip MiFi™
STANDARD CATHETER IntellaTip MiFi™
: IntellaNav™ XP IntellaNav™ MiFi XPEP-Shuttle
5.
Maestro EP-Shuttle
![Page 23: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/23.jpg)
RHYTHMIA HDx™ 17
6.
IntellaTip MiFi™
IntellaNav™
7.5.5 (Stimulator Jumper Cables)( 7) (
2 1 13) ( 2 1 )
• SiSRhythmia
• M A B ABLM A B
61 62ABL
1 2
7.
Standard Catheter
![Page 24: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/24.jpg)
18 RHYTHMIA HDx™
7.5.6 (Location Reference Back Patch)
( )
( 8) SiSPATCH ( 2 1 10)
8.
7.6 SiS (SiS Front Panel Outputs)3
IC 3 OUT-MOUT-A+ABL OUT-B
7.6.1 (Direct Connect IC Cables)( 9) SiS
Clearsign™ CardioLab™ 2
( 10)
• Clearsign Direct Connect Clearsign™ IC Orion™ IntellaMap Orion
OUT-M Direct Connect Clearsign™ IC A/B
3OUT-A+ABL
65 72
• CardioLab Direct Connect CardioLab™ IC3
OUT-A+ABL33 40 33 40
![Page 25: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/25.jpg)
RHYTHMIA HDx™ 19
9.
Direct Connect Clearsign™ IC Orion™ Direct Connect Clearsign™ IC A/B Direct Connect CardioLab™ IC
7.6.2 ECG (Direct Connect ECG Cables)ECG ( 10) SiS
Clearsign™ CardioLab™ OUT-ECG
( 2 1 9)
10.
Direct Connect Clearsign™ ECG Direct Connect CardioLab™ ECG
ECG
7.6.3 (Rhythmia IC Out 72 Cable)( 11) 3 IC
![Page 26: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/26.jpg)
20 RHYTHMIA HDx™
11.
7.6.4 ECG (ECG Output Box)ECG ( 12) SiS ECG
ECG SiSOUT-ECG ( 2 1 9) ECG
: ECG
ECG
12.
IEC
ECG
![Page 27: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/27.jpg)
RHYTHMIA HDx™ 21
7.7 SiS (SiS Rear Panel Description)SiS ( 13) SiSSiS 3
14
13. 3: SiS
1
2
3
4
5SiS
6 : SiS
SiS
7
![Page 28: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/28.jpg)
22 RHYTHMIA HDx™
14.
AC
AC
–
7.8 SiS (SiS Rear Panel Connections)7.8.1 (Localization Generator
Input Port)
( 15) ( 313 1)
15.
![Page 29: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/29.jpg)
RHYTHMIA HDx™ 23
:
:
: CIED()
CIED: CIED
7.8.2 (Workstation Data Connection)( 16) SiS
16.
7.8.3 (Foot Switch) ( )( 17)
17.
![Page 30: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/30.jpg)
24 RHYTHMIA HDx™
7.8.4 (Electric Power Input)( 18) SiS 24 V DC
250WSiS
AC(UPS)
18. SiS
7.9 (Workstation Description)
( 19) SiS
19.
SiS
7.10 (Workstation System Requirements):100 240 V 50/60Hz 8A
7.11 (Workstation Setup)
:
![Page 31: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/31.jpg)
RHYTHMIA HDx™ 25
8. (PREPARING FOR A MAPPING STUDY)8.1 (Prior to Patient Arrival)
8.1.1 (Setup the Hardware and Make the Cable Connections)
SiS SiS
SiS
SiS
SiS SiS LED SiS IN-M IN-A IN-B
(M A B)
ECG SiS (
) SiS EP (OUT-M OUT-A+ABL
OUT-B)• Clearsign™ : Direct Connect
Clearsign™ IC Orion™ IntellaMap OrionOUT-M Direct
Connect Clearsign™ IC A/B3
• GE CardioLab™ :Direct Connect CardioLab™ IC 3
OUT-A+ABL33 40 33 40
•
ECG ECG ECG
SiS PATCH
![Page 32: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/32.jpg)
26 RHYTHMIA HDx™
SiSSTIM IN
()
8.1.2 (Prepare the Workstation)
Rhythmia
8.2 (Upon Patient Arrival)8.2.1 (Make Required Cable and
Catheter Connections) ECG
ECG LIMB CHEST ECG
• ECG LIMB CHEST
• LIMB CHEST TRUNK
IN-A
1
61 62
8.2.2 IntellaMap Orion (Additional Connections When Using One of the IntellaMap Orion Family of Catheters)
IN-M ( 11)
8.3 (Important Considerations During a Study)
SiS "resume"
![Page 33: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/33.jpg)
RHYTHMIA HDx™ 27
SiS
•
• SiS LED –
: SiS
: SiS
:
8.4 (Ending the Study)SiS
1. SiS On/Off
2.
3. SiS ( 12)
![Page 34: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/34.jpg)
28 RHYTHMIA HDx™
9. (INDIVIDUAL CABLES ASSOCIATED WITH SYSTEM)
IntellaMap OrionSiS
IN-M
IntellaMap OrionSiS 64
SiSIN-M IN-A
IN-B
SiS (IN-MIN-A IN-B)
ECGECG IN CHEST
ECG SiSIN-ECG
CHEST LIMB ECG TRUNKECG IN LIMB
ECG IN TRUNK TRUNK CHEST LIMBSiS SiS
- - 2-2
()
SiS SiS
-Direct Connect Clearsign™ Direct Connect Clearsign™ ECG (3m 6m)
SiS OUT-ECG
Clearsign SiSClearsign
SiS
Direct Connect Clearsign™ IC Orion (3m 6m)
SiS OUT-M
–
Direct Connect Clearsign™ IC A/B (3m 6m)
SiS OUT-A+ABLOUT-B
–
-Direct Connect CardioLab™ Direct Connect CardioLab™ ECG (3m 6m)
SiS OUT-ECGCardioLab SiS GECardioLab
SiSDirect Connect CardioLab™ IC (3m 6m)
SiS OUT-MOUT-A+ABL OUT-B
![Page 35: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/35.jpg)
RHYTHMIA HDx™ 29
-SiS OUT-MOUT-A+ABL OUT-B SiS (OUT-M OUT-A+ABL OUT-B)
USB RS232
DB9 RS232Strt Thr M/F
10ft
USBRS232 Maestro™
DB9 RS232F/F 10ft
USBRS232 EP-Shuttle
Rhythmia SiS SiS PATCH
RHYTHMIA HDx™ : AC: SiS
AC SiS DCSiS
SiS
SiSSiS
SiS SiS
AC
AC
![Page 36: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/36.jpg)
30 RHYTHMIA HDx™
10. (DIRECT CONNECT CHANNEL MAPPING)
Clearsign™ IC Orion™
( )
Clearsign™ ICA/B
( )
CardioLab™ ( 3 )
OUT-M OUT-A+ABL OUT-M OUT-B OUT-M OUT-A+ABL OUT-B
Orion
A1 A8 1-8 BB 1 64 1-64 BB 1 64 1-64 Orion A1 H8 1-64
BB 1 32 1-32 BB 1 64 1-64
B1 B8 11-18 ABL 1 8 65-72 BB 1 64 ABL 1 8 33-40
C1 C8 21-28 BB 33 40 N/A
D1 D8 31-38 BB 41 64 41-64
E1 E8 41-48
F1 F8 51-58
G1 G8 61-68
H1 H8 71-78
: BB= ABL=
![Page 37: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/37.jpg)
RHYTHMIA HDx™ 31
11. IntellaMap Orion (PREPARING INTELLAMAP ORION FAMILY OF CATHETERS FOR USE)
IntellaMap Orion
1. IntellaMap Orion
2. SiS M
3. SiS
4. SiS
5.
6.
7. IntellaMap Orion
8. SiS Condition10
9.
: RHYTHMIA HDx™ RHYTHMIA HDx™ MAPPING SYSTEM
SOFTWARE DIRECTIONS FOR USE
12. (CLEANING GUIDELINES)12.1 (Routine Cleaning and Disinfecting)
•
•
•
•
12.2 (Decontaminating the Equipment Before Shipping)
![Page 38: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/38.jpg)
32 RHYTHMIA HDx™
:
:
:
:
:
13 SiS (SiS TROUBLESHOOTING)LED
SiS
4:
SiS SiS 2
SiS1. SiS
2. LIVE
SiS
: LIVE
![Page 39: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/39.jpg)
RHYTHMIA HDx™ 33
14. (ELECTROMAGNETIC EMISSIONS AND IMMUNITY)
5: –
RHYTHMIA HDx
– RF EN 55011 CISPR 11
1 RHYTHMIA HDx RFRF
RHYTHMIA HDx
:RHYTHMIA HDx
RHYTHMIA HDx
RF EN 55011 CISPR 11
A
EN 61000-3-2
A
EN 61000-3-3
A
![Page 40: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/40.jpg)
34 RHYTHMIA HDx™
6: – RHYTHMIA HDx
IEC 60601
(ESD)IEC 61000-4-2
6kV8kV
30%
IEC 61000-4-4
2kV AC1kV
(AC )IEC 61000-4-5
1kV2kV -
IEC 61000-4-11
>95% (UT )0.560% (UT )530% 25>95% (UT )5
RHYTHMIA HDxRHYTHMIA HDx
(UPS)
(50/60Hz)
IEC 61000-4-8
3A/m
RFIEC 61000-4-6
3V rms150kHz 80MHz
RFRHYTHMIA HDx
RFIEC 61000-4-3
3v/m80MHz 2.5GHz
:
1.17V1
√Pd =[ ] 150kHZ 80MHz
√Pd = 1.17E1[ ] 80MHz 800MHz
√Pd = 2.33E1[ ] 800MHz 2.5GHz
P
( W) d (m)
1: UT AC2: 80MHz 800MHz3:
![Page 41: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/41.jpg)
RHYTHMIA HDx™ 35
7: RF
RF RHYTHMIA HDx
RHYTHMIA HDx RFRF ( ) RHYTHMIA HDx
W
m150kHz 80MHz
1.17V1
√Pd =[ ]80MHZ 800MHz
√Pd = 1.17E1[ ]
800MHZ 2.5GHz
√Pd = 2.33E1[ ]
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
d( m)P (
W)1: 80MHz 800MHz2:
![Page 42: RHYTHMIA HDx - Boston Scientific- US · 2 RHYTHMIA HDx™ G]G GWG4G5G0 v 1 Â i 1.2.2 2 ' ø ù ô(System Software) RhythmiaGKGcGVG4G5G0FÿF¸G}G G=GGGTG GEGuG VF÷ 8 ·FéG F¹FãFþGKGcGVG4G5G0FÿF¸](https://reader031.vdocument.in/reader031/viewer/2022011900/5f02cbf97e708231d4060e5e/html5/thumbnails/42.jpg)
36 RHYTHMIA HDx™
15. (TECHNICAL SPECIFICATIONS)
SiS SiS
12 ECG
IntellaMap Orion (64)
(128 )+(8 ): ( 2 )
:
: Maestro™ EP-Shuttle
: XP Power
: AHM250PS24-XD0653
: 100 240VAC/50Hz 100 220VAC/60Hz
: 2.3A 115VAC 1.2A 230VAC
: 24VDC
: 250W : 10.41A
IEC 60601-1:2005+A1:2012 IEC 60601-1-2:2007 IEC 60601-1-6:2010+A1:2013 IEC 60601-2-27:2011 CORR 1:2012 IEC 62366:2007+A1:2014EN 55011:2009+A1:2010, Group 1, Class A; CISPR 11:2009+A1:2010, Group 1, Class A
: Class I Type CF
: IPX1 : 5
LinuxSiS
: 100 240VAC
: 8.0A
: 50 60Hz
• : 10 (50 ) 30 (86 )• : 30% 75%• : 580 760 mmHg
• – 29 +60• 10 90%
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RHYTHMIA HDx™ 37
16. (SERVICE INFORMATION)
17. (CONTACTS)
( )
( )
( )
800 949 6708 0031 (0)45 5467707 0120-177-779 510 624 2493 0031 (0)45 5467805
[email protected] [email protected] [email protected]
CardioLab GE Medical Systems
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38 RHYTHMIA HDx™
18. RHYTHMIA HDx
8:
{ IntellaMap Orion
ECG
CF
LOT
REF NONSTERILE
SN
EC REP
AUS
ARG
BRA
TUR
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RecyclablePackage
LegalManufacturer
Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752USAUSA Customer Service 888-272-1001
Do not use if packageis damaged.
EU AuthorizedRepresentative
Boston Scientific LimitedBallybrit Business ParkGalwayIRELAND
EC REP
Boston Scientific (Australia) Pty LtdPO Box 332BOTANYNSW 1455AustraliaFree Phone 1800 676 133Free Fax 1800 836 666
Sponsor AddressAustralian
AUS
ArgentinaLocal Contact
Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link www.bostonscientific.com/arg
ARG
TurkeyLocal Contact
Boston Scientific Tıp Gereçleri Ltd. Şti.Altunizade Mah. Ord. Prof. Fahrettin Kerim Gökay Cad. 45/1Üsküdar 34662, İstanbulTel +90 216 544 47 00 Faks +90 216 544 47 01
TUR
BrazilLocal ContactBRA
Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra