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RHYTHMIA HDx™

92022381-01AEPT-022

2017-06

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

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

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

iv RHYTHMIA HDx™

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

: ()

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

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

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)

•

•

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)•

•

6 RHYTHMIA HDx™

3.5 (Cables)• ECG

ECG SiSECG

• SiS

•

•

•

15

3.6 (Electrical)•

3.7 (Body Surface Electrodes)•

•

• ECG

3.8 (Environmental)•

•

•

•

15

RHYTHMIA HDx™ 7

3.9 (Magnetic Localization System)•

• 3cm 3cm

•

•

• SiS

•

•

• (CIED)

CIED

• CIED

3.10 (Cleaning and Disinfecting)•

•

•

•

•

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)

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)

10 RHYTHMIA HDx™

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

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

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

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

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 )

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

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

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

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

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

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

22 RHYTHMIA HDx™

14.

AC

AC

–

7.8 SiS (SiS Rear Panel Connections)7.8.1 (Localization Generator

Input Port)

( 15) ( 313 1)

15.

RHYTHMIA HDx™ 23

:

:

: CIED()

CIED: CIED

7.8.2 (Workstation Data Connection)( 16) SiS

16.

7.8.3 (Foot Switch) ( )( 17)

17.

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)

:

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

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"

RHYTHMIA HDx™ 27

SiS

•

• SiS LED –

: SiS

: SiS

:

8.4 (Ending the Study)SiS

1. SiS On/Off

2.

3. SiS ( 12)

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

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

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=

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)

32 RHYTHMIA HDx™

:

:

:

:

:

13 SiS (SiS TROUBLESHOOTING)LED

SiS

4:

SiS SiS 2

SiS1. SiS

2. LIVE

SiS

: LIVE

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

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:

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:

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%

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

38 RHYTHMIA HDx™

18. RHYTHMIA HDx

8:

{ IntellaMap Orion

ECG

CF

LOT

REF NONSTERILE

SN

EC REP

AUS

ARG

BRA

TUR

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

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