Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System...

60
EPT-012 Maestro 3000 TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 Manufactured for: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 USA USA Customer Service 888-272-1001 Boston Scientific International S.A. 55 avenue des Champs Pierreux TSA 51101 92729 NANTERRE CEDEX FRANCE Made in USA: 1346 Bordeaux Drive Sunnyvale, CA 94089 USA 2011-07 ᵈᗧ ☨࿖ㅪ㇌ᴺޔࠅࠃߦᧄຠ⽼ߩޔߪකᏧ ޔ߆ࠆࠃߦߪߚ߹කᏧߩᜰ␜ߩߢ⟵߇ߣߎࠆࠇࠊߡࠇࠄߌߠ߹ ߔࡠ࠲⇟ภ Australian Sponsor Address Legal Manufacturer EU Authorized Representative Do not use if package is damaged. ࠤ࠶ࡄ߇ߡߒ႐วߪߥߒ ޕߣߎຠ⇟ภ 90851370-01A

Transcript of Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System...

Page 1: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

Maestro 3000TM Cardiac Ablation System

Operator’s Manual, 100

Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666

Manufactured for: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 USA USA Customer Service 888-272-1001

Boston Scientific International S.A. 55 avenue des Champs Pierreux TSA 51101 92729 NANTERRE CEDEX FRANCE

Made in USA: 1346 Bordeaux Drive Sunnyvale, CA 94089 USA

2011-07

Australian Sponsor Address

Legal Manufacturer

EU Authorized Representative

Do not use if package is damaged.

90851370-01A

Page 2: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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1.0 ......................................................................1 1.1 ............................................................................... 4 1.2 .......................................................................................... 5 1.3 ...................................................................................... 5

1.3.1 ......................................................................... 5 1.3.2 ......................................................................... 5

2.0 ..............................................................................7 2.1 ............................................................................... 7 2.2 ................................................................................................. 7

3.0 ....................................................8 3.1 ................................................................................................. 8 3.2 ................................................................................... 9 3.3 .......................................................................................... 11

4.0 - Remote Control UnitPod.........................................................................................12

4.1 ............................................................................... 12 4.1.1 (A & B) ......................................................... 14 4.1.2 (C & D) ........................................................ 14 4.1.3 (E & F) ................................... 15 4.1.4 (G & H) ........................................................ 17 4.1.5 (I) ............................................................. 17 4.1.6 (J) ................................................................ 17 4.1.7 (K) RF .............................................................. 17 4.1.8 (L) ON/OFF .................................................... 17 4.1.9 (M) ................................................. 17 4.1.10 (N) ............................................. 17 4.1.11 (O) .......................................................................... 17 4.1.12 (P) ............................................................ 18 4.1.13 (Q) ............................................................ 18 4.1.14 (R) ...................................... 19 4.1.15 (S & T) .................. 19

Page 3: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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4.1.16 (U) .......................................................................... 19 4.1.17 (V) .......................................................................... 20 4.1.18 .................................................................. 20

4.2 ................................................................................... 20 4.2.1 (A) RF TWA ............................................... 22 4.2.2 (B & C) ................................... 22 4.2.3 (D) ...................................................................... 22 4.2.4 (E) Footswitch ....................................... 22 4.2.5 (F) Remote Control ......... 22 4.2.6 (G) ............................................. 22 4.2.7 (H) ...................................................................... 23

4.3 Pod ....................................................................................... 23 4.3.1 Pod ............................................................... 25 4.3.2 Pod .................................................................. 25

4.4 Footswitch ................................................... 25 4.5 Remote Control Unit .................................... 25

5.0 .................................................................................27 5.1 .......................................................................................... 27

5.1.1 .................................................................. 28 5.1.2 DIP .............................................................................. 29 5.1.3 Footswitch ......................................... 29

5.2 ON ............................................................... 29 5.3 ........................................................................ 30 5.4 ............................................................................ 30 5.5 .......................................................................................... 30 5.6 ............................................................................... 31 5.7 ................................................................. 32 5.8 ............................................................................... 32 5.9 ............................................................................ 32 5.10 ..................................................................... 32 5.11 .......................................................... 33 5.12 RF ON ......................................................................... 33 5.13 RF OFF ....................................................................... 34

6.0 ....................................................35 6.1 .......................................................................................... 35 6.2 ........................................................................ 35

Page 4: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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6.3 ...................................................................................... 35 6.4 ESD ........................................... 35 6.5 ...................................................................................... 36

7.0 .................................................................................37 7.1 .......................................................................................... 37 7.2 Maestro 3000TM Cardiac Ablation System ......................... 41 7.3 .......................................................................................... 45 7.4 ................................................................................................. 46 7.5 .......................................................................................... 49 7.6 ...................................................................................... 50

8.0 ..............................................................................51 8.1 ...................................................................................... 51

9.0 ............................................................52 9.1 .......................................................................................... 52 9.2 ................................................... 53 9.3 ........................................................................ 53

Page 5: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

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1.0 Maestro 3000TM Cardiac Ablation System 1-1 Radiofrequency (RF) Cardiac Ablation Maestro 3000 BSC

21000TC RF Cardiac Ablation System Maestro 3000 Pod

BSC 21860T

Hospital Grade Power Line Cord 2 Controller Power Line Cord1 Remote Control Power Line

Cord 1

Maestro 3000 Cardiac Ablation System BSC RF Cardiac AblationPod

Maestro 3000 Cardiac Ablation System 3

1-2

Maestro 3000 RF Cardiac Ablation Remote Control Unit BSC 21880

Remote Control )

Remote Control Unit

BSC SVGA25 25 (7.62 m)

BSC SVGA50 50 (15.24 m)

BSC SVGA75 75 (22.86 m)

Footswitch BSC 21840

Realtime Position Management (RPM ) Fiber Optic Cable

BSC 2064 3.3 (1 m)

BSC 2037 16.4 (5 m)

BSC 2049 65.6 (20 m)

Page 6: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EP

T-01

2

1-1

2

* *

*

*

RPM

*

*

*

R

PM*

*

POD

/EG

M

*

POD

RPM

*

2186

0T

POD

100

DIP

* D

IP*

*

*MA

ES

TRO

300

0TM C

ardi

ac A

blat

ion

Sys

tem

Page 7: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EP

T-01

2

1-2

Pod

3

651

9

3

652

69

3

703

S9

4

9 6

CH

ILLI

II™

2053

RPM

Pod

681

CH

ILLI

IIPo

d

"218

60T

POD

100

"

2160

0Po

dR

PM™

RPM

MAE

STR

O 3

000TM

(15

)

653S

6

3

APM

–EG

M

EGM

RPM

Page 8: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

4

1.1 Maestro 3000TM Cardiac Ablation System

Maestro 3000 460 kHz (RF)RPM™ )

Realtime Position Management (RPM) 84% 1 kHz 460 kHz RF RPM

RF RPM

(150 300 )

RF Temperature Control ( ) Power Control ( ) 2

RF

RF RF

Pod RF RF

Pod RPM Chilli II™BSC

Blazer II™ Blazer II HTD™ Blazer PrimeTM HTD Blazer RPMTM

SteeroCath-T™ Chilli IIBlazer II XP™ Blazer PrimeTM XP Blazer XP RPM™

5 5

Remote Control Remote Control Unit 25(7.62 m) 50 (15.24 m) 75 (22.86 m) 3

View Settings ( ) RF

Page 9: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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1.2 Maestro 3000TM Cardiac Ablation System IEC 60601

Maestro 3000 Cardiac Ablation System

50W RF 50 1

100W RF 25 1

(150 300 ) 1

85 1

95 1

5 C 4

Pod DIP 1.1

1.3 Power Control ( ) Temperature

Control ( ) 2

1.3.1

RF

1.3.2

Page 10: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

6

1-1 Pod

1-1

(W)

(Amp)

50 1

50 1

100 2

Chilli II™

50 1

Page 11: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7

2.0

2.1 Maestro 3000TM Cardiac Ablation System BSC

Maestro 3000 Cardiac Ablation System

Maestro 3000 Cardiac Ablation SystemMaestro 3000 Cardiac Ablation

System

2.2 Maestro 3000 Cardiac

Ablation System Maestro 3000 Cardiac Ablation System

Page 12: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

8

3.0 Maestro 3000TM

3.1

80 C

RF

OOO

RF

IEC 60601-1

Recorder ( ) Pod

Hospital Only ( ) Hospital Grade ( )

Page 13: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

9

IEC( IEC 950 IEC

60601-1)IEC 60601-1-1

IEC 60601-1-1

BSC

Booker BoxDIP

DIP

RF (EMI) 1

BSC RF

Maestro 3000TM Cardiac Ablation System

Maestro 3000 Cardiac Ablation System

Maestro 3000 Cardiac Ablation System

Maestro 3000 Cardiac Ablation System

3.2

BSC Maestro 3000 Cardiac Ablation System

RF Impedance ( ) RF

RF (ECG)

Page 14: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

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(DIP)

DIP

2 DIP

DIP

DIP

DIP

RF

Remote Control

Boston Scientific

Page 15: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

11

Pod

Remote ControlBSC

Pod

Maestro 3000TM Cardiac Ablation System EMC7.2 EMC

RF Maestro 3000 Cardiac Ablation SystemMaestro 3000 Cardiac Ablation System

ESD ESD

Maestro 3000 Cardiac Ablation SystemESD ESD

ESD 6.4

3.3

Maestro 3000 Cardiac Ablation System

Page 16: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

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4.0 - Remote Control Unit Pod

4.1 Maestro 3000TM Cardiac Ablation System

Remote Control

4-1 Remote ControlRemote

Control Unit 4.5Remote Control Unit

Page 17: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EP

T-01

2

4-

1

13

(A)

(B)

(U)

(T)

(S

)

(R)

(O)

(P)

(Q)

(D)

(C)

(F)

(E)

(H)

(G)

(I)

(J)

(K) R

F

(L)

(M)

(N)

(V)

Page 18: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EPT-012

14

4.1.1 (A & B)

[Power ( )] - RF 1W 100W1W

4-1 (A)

4-1 Pod

4-1:

(W) 1 - 50 1 - 100

Power ( ) - RF4-1 (B) )

4.1.2 (C & D)

[Temperature ( )] - 4-2 1

4-2:

30°C 90°C 30°C 80°C

4-31 4-1 (C)

4-3:

30°C 95°C 30°C 85°C

Temperature ( ) - STANDBY ( ) DELIVER ( )

30°C 4-1 (D) )

4-4

Page 19: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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15

4-4

30 C

20 C 120 C

(---)

85 C

20 C 120 C

(---)

(---)

4.1.3 (E & F)

[Impedance ( )] - 150 300 1 4-1 (E)

)

Impedance ( ) - 300

STANDBY ( ) DELIVER ( ) 4-1 (F) )

Page 20: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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16

4-5

4-5

60 150

RF

< 50

RF

LO( )

< 25

RF

LO( )

RF

HI( )

999 1

DIP1.1 Amp

RF

HI( )

1. 8-1

Page 21: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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17

4.1.4 (G & H)

[Time ( )] - RF 1 1201 RF

4 4-1 (G) )

Time ( ) - [RF Power Control (RF )] Footswitch

4-1 (H) )

4.1.5 (I)

[Clear ( )] - RFRF RF 4-1

(I) )

4.1.6 (J)

[View Settings ( )] - RF

4-1 (J) )

4.1.7 (K) RF

[RF Power Control (RF )] - RF 4-1 (K) )

4.1.8 (L) ON/OFF

[Mains ( )] - ON/OFF 4-1 (L) )

4.1.9 (M)

4.1.18

4.1.10 (N)

- RFRF 4-1 (N) )

4.1.11 (O)

- 4-6 4-1 (O) )

Page 22: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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18

4-6

STANDBY ( )

20 C 120 C

(---)

20 C 120 CHI ( ) LO ( )

0 999 999 HI ( )

2 RF4 RF

0 0 99 1

MM:SS ( )

[AVERAGE ( )] [MAXIMUM ( )]

DELIVER ( )

[AVERAGE ( )] [MAXIMUM ( )]

M01- LIMITED OUTPUT (M01- )

M01 (>150 ) DIP RF

DIP DIAGNOSTIC ( )

(

8

4.1.12 (P)

4.1.18

4.1.13 (Q)

Pod 4-1 (Q) )

Page 23: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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19

4.1.14 (R)

[RF Power Control (RF )] RF OFFRemote Control Unit

RF4-1 (R) )

4.1.15 (S & T)

[Control ( )] – Power ( ) Temperature ()

RF4-1 (S) )

– LED)

Chilli II™( 4-1 (T)

)

Chilli II)

4-1 (T) )

4.1.16 (U)

DELIVERY ( ) STANDBY ( )

4-1 (U) )

Page 24: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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20

4.1.17 (V)

DELIVERY ( ) STANDBY ( )

4-1 (V) )

4.1.18

System Fault ( ) – 4-1 (M) )

“Temperature Power ”– 4-1 (T) )

RF Power Control (RF ) –

Memory ( ) LED 5 )

Panel Active ( ) – 4-1 (P) )

Average ( ) LED )

Maximum ( ) LED )

4.2 4-2

4-4 Remote Control UnitRemote Control Unit

4.5 Remote Control Unit

Page 25: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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(

C)

(B)

(G)

(E)

(A) R

FTW

A

(H)

(D)

(F)

4-2

Page 26: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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4.2.1 (A) RF TWA

RPM™ PodBSC BSC Position Acquisition

Module (PAM) RF RPM4-2 (A) )

4.2.2 (B & C)

Hospital Grade ( )Hospital Grade ( ) Hospital Only ( )

AC 4-2 (B) (C) 4-4 (B) (C) )

4.2.3 (D)

4-2 (D) 4-4 (D) )

4.2.4 (E) Footswitch

Footswitch 4-2 (E) )

4.2.5 (F) Remote Control

Remote Control Unit 4-2 (F) 4-4 (F) )

4.2.6 (G)

PC / 4-

2 (G)

Page 27: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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23

4.2.7 (H)

4-2 (H) 4-4 (H) )

OFF

4.3 Pod Pod RF RF

PodBSC

Pod RF (460 kHz) 2 DIP

Pod 7-1

Page 28: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

EP

T-01

2

24

PO

D

4-3

Pod

PO

D

Page 29: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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4.3.1 Pod

4-3)

STD/XP 9 (XP) BSC 1-2

RPM 22 RPMTM

BSC 1-2

Indifferent Electrode ( ) 2 2DIP

4.3.2 Pod

EP Recorder (EP ) 6 BSC 653SPod

RPM Output (RPM ) 9 BSC 21600Pod RPM

Pod Pod Isolated Patient Connector ( )

Pod PodPod

IEC 60601

4.4 Footswitch RF ON OFF Footswitch

10 RF

4.5 Remote Control Unit Remote Control

4.1 4.2 )Remote Control 25 (7.62m) 50 (15.24m) 75

(22.86m)4-4

Page 30: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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(B)

(C)

(H)

(F)

4-4

(D)

Page 31: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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5.0

5.1

IEC 60601-1-1

IEC 60601-1-1 1-1

IEC 60601-1-1 1-2

IEC 60601-1-1

Hospital Grade ( ) Hospital Grade ( ) Hospital Only

( ) AC

AC Hospital Grade ( )Hospital Only ( )

Pod Remote Control Footswitch

Pod

Pod Isolated Patient Connector ( ) Pod

Footswitch Remote Control

ESD ESD

Maestro 3000TM Cardiac Ablation SystemESD ESD

ESD 6.4

Remote Control 25 (7.62m) 50(15.24m) 75 (22.86m)

Page 32: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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28

IEC 60601-1

RS232

5.1.1

Pod 1-2 Maestro 3000TM Cardiac Ablation SystemBlazer II™ Blazer II HTD™ Blazer PrimeTM HTD Blazer II XP™ Blazer PrimeTM XP Blazer RPM™ Blazer XP RPM SteeroCath-T™ Chilli II™BSC

Maestro 3000TM Cardiac Ablation SystemMaestro 3000 Cardiac

Ablation System

Page 33: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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29

5.1.2 DIP

BSC Megadyne DIP

DIP 1 2 PodIndifferent Electrode ( ) 24-3

DIP

DIP 1.1 RF

RF DIP

5.1.3 Footswitch

FootswitchFootswitch Footswitch [RF POWER CONTROL

(RF )] RF FootswitchRF Footswitch

5.2 ON ON

I ) 4-1

Remote Control Remote Control ONRemote Control I )

4-1

2STANDBY ( )

Pod

OFF ON

8

Page 34: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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5.3 STANDBY ( ) RF

Remote Control [RF Power Control (RF )]

Temperature ( ) Impedance ( ) Power () Time ( ) Counter ( )

300 4-1

4-4 )

5.4 [Control ( )] Power Control ( )

Temperature Control ( )BSC

Chilli II™ BSC) RF

4-1

5.5 RF Temperature Control ( ) Power Control (

)

RF (W) [Power ( / ) ( )] RF1W

[Power ( / ) ( )] ( 4-1 (A) (B) )

RF

RF RF [Power ( / ) ( )]1W

RF RF [Power ( / ) ( )]

)

Page 35: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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31

Chilli II™

)

RF

Pod 100W RF

50W

Chilli II 50W

5.6 [Temperature ( / ) ( )]

1°C [Temperature ( / ) ( )] 4-1 (C)

(D)

RF RF [Temperature ( / ) ( )]1°C

RF RF [Temperature ( / ) ( )]

)

30° 80°C 1°C

30° 85°C 1°C

(55 C70 C)

Page 36: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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32

5.7 [Impedance ( / ) (

)] 1 [Impedance ( / ) ( )]

4-1 (E)(F) 150 300

RF RF [Impedance ( / )( )]1

RF RF [Impedance ( / ) ( )]

)

5.8 RF [Time ( / ) ( )]120 ) [ Time ( / )( )] [Time ( / ) ( )]

44-1 (G) (H)

[(Time ) ( )] [(Time ) ( )] )

5.9 RF [Clear ( )]

2020

99

5.10 [Maximum ( )] [Average ( )][Maximum ( )] [Average ( )]

21 2

4-1 (U) (V)

Page 37: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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33

5.11 RF [Memory ( )]

4-1 (N)

[Maximum ( )] [Average ( )]

ON OFF

[ ] 2

[ ]

5.12 RF ON

Remote Control [Generator Remote ( )] 4-1 (R)

)

RF [RF Power Control (RF )]Footswitch Power( ) RF (W)

RF

Remote Control ON

[RF Power Control (RF )] )

RF Remote Control

RF

[RF Power Control (RF )] – RFRF

5.13 RF OFF

Power ( ) – RF (W)

Temperature ( ) – ( C)

[View Settings ( )]

Page 38: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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34

Time ( ) – RF ( )

Impedance ( ) – ( )

M01- LIMITED OUTPUT (M01- )

5.13 RF OFF RF

RF (RF )

Remote Control [RF Power Control (RF)]

Footswitch

RF

RF RF

Pod DIP 2 1.1

50 1

25 1

(150 300 ) 1

5oC 4)

85oC 1)

1

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35

6.0

6.1

Boston Scientific

6.2

Boston Scientific

6.3 Pod Remote Control

Remote Control

6.4 ESD Maestro 3000TM Cardiac Ablation SystemESD

EDSESD

ESDESD

Page 40: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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36

ESD

6.5

BSC BSC1-800-949-6708)

Page 41: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7.0 7.1

7-1 Remote Control Unit Pod

7-1

100-120/220-240 V~

Remote Control

4 A, 50/60 Hz 1 A, 50/60 Hz

Remote Control

2(x) T4A/250 V 2(x) T1A/250 V

(3.0 m) 10 ft.

Footswitch

(3.0 m) 10 ft

Pod

(4.6 m) 15 ft. 14

Pod

( )

(5.8 cm) 2.3 in. (17.3 cm) 6.8 in. (15.7 cm) 6.2 in.

(1.0 kg) 2.2 lb.

Pod - CF -

RPM™ - CF -

Page 42: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7-1

Pod

RPM™

9 - CF -

22 - CF -

Pod 2 - CF -

Pod

–3 dB 5 kHz 1 kHz

1.1 AmpRF

RF @ 460 kHz

50 W 50

1.1 Amp 100 W 25

2 Amp 132 Vrms 186 Vpk RF

Blazer RPMTM Blazer XP RPMTM

Page 43: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7-1

4-5

STANDBY ( ) 0 999

DELIVER ( )

50W RF 50

100WRF 25

50 ( 25 ) 300 LO ( )

HI ( )

30 C 80 C ( )

---

20 120 C

LO ( ) HI ( )

(18.3 cm) 7.2 in. (32.8 cm) 12.9 in. (38.1 cm) 15.0 in.

(7.7 kg) 16.95 lb.

1 0 120

RF 0 99

Page 44: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7-1

– RF 3

500 Hz – 1.5 kHz – 2.5 kHz 1 kHz 500 Hz 300 Hz

Remote Control Unit

(18.3 cm) 7.2 in. (32.8 cm) 12.9 in. (18.8 cm) 7.4 in.

(2.6 kg) 5.8 lb.

Page 45: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7.2 Maestro 3000TM Cardiac Ablation System

I CF IPX0 AP/APG

EMC Maestro 3000 Cardiac Ablation System IEC 60601-1-2:2001

TUV Rheinland of North America, Inc.

IEC 60601-1

IEC 60601-1

Maestro 3000 Cardiac Ablation SystemMaestro 3000 Cardiac Ablation System

RF

CISPR 11

2 Maestro 3000 Cardiac Ablation System

RF

CISPR 11

A

IEC 61000-3-2

A

IEC 61000-3-3

Maestro 3000 Cardiac Ablation System

Page 46: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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Maestro 3000TM Cardiac Ablation SystemMaestro 3000 Cardiac Ablation System

IEC 60601

ESD

IEC 61000-4-2

±6 kV

±8 kV ±6 kV

±8 kV

30%

IEC 61000-4-4

±2 kV

±1 kV ±2 kV

±1 kV

IEC 61000-4-5 ±1 kV

±2 kV ±1 kV

±2 kV

IEC 61000-4-11

<5% UT

(UT >95%) 0.5

40% UT

(UT 60%) 5

70% UT

(UT 30%) 25

<5% UT

(UT >95%) 5

<5% UT

(UT >95%) 0.5

40% UT

(UT 60%) 5

70% UT

(UT 30%) 25

<5% UT

(UT >95%) 5

Maestro 3000 Cardiac Ablation System

UPS

(50/60 Hz

IEC 61000-4-8

3 A/m 3 A/m

UT

Page 47: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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Maestro 3000TM Cardiac Ablation SystemMaestro 3000 Cardiac Ablation System

IEC 60601

RF IEC 61000-4-6

RF

IEC 61000-4-3

3 Vrms 150 kHz 80 MHz

3 V/m 80 MHz 2.5 GHz

3 Vrms

3 V/m

RF

Maestro 3000 Cardiac Ablation System

)

Pd 17.1

Pd 17.1 80 MHz 800 MHz

Pd 33.2 800 MHz 2.5 GHz

PW d

m RF

a b

1 80 MHz 800 MHz 2

a AM FM TV

RFMaestro 3000 Cardiac

Ablation SystemRF Maestro 3000 Cardiac Ablation System

Maestro 3000 Cardiac Ablation System

b 150 kHz 80 MHz 3 V/m

Page 48: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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Maestro 3000TM Cardiac Ablation System RFMaestro 3000 Cardiac Ablation System RF

Maestro 3000 Cardiac Ablation System

M

W

150 kHz 80 MHz

Pd 17.1

80 MHz 800 MHz

Pd 17.1

800 MHz 2.5 GHz

Pd 33.2 0.01 0.18 0.18 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.70 3.70 7.37

100 11.7 11.7 23.3

d PW

1 80 MHz 800 MHz

2

Page 49: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7.3 7-2

7-2

–40 C 70 C

10% 100%

500 1060 mb

15 C 40 C

30% 75%

700 1060 mb

Page 50: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7.4

50W 100W

7-1 7-2 7-3, 7-47-5 100

Maestro 3000TM

7-1 Maestro 3000

20

25

30

35

40

45

50

55

0 50 100 150 200 250 300 350

( )

(W)

50 W, 1 A 50 W, 1 A25 W, 1 A 25 W, 1 A

Page 51: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7-2 Maestro 3000TM

7-3 Maestro 3000 RPM

30

40

50

60

70

80

90

100

110

0 50 100 150 200 250 300 350

( )

(W)

- 100 W, 2 A - 100 W, 2 A - 50 W, 2 A - 50 W, 2 A

15

20

25

30

35

40

45

50

55

0 50 100 150 200 250 300 350

( )

(W)

- 50W, 1A - 50W, 1A

- 25W, 1A - 25W, 1A

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7-4 Maestro 3000TM RPM™

7-5 Maestro 3000

20

30

40

50

60

70

80

90

100

110

0 50 100 150 200 250 300 350

( )

(W)

- 100 W, 2 A - 100 W, 2 A - 50 W, 2 A - 50 W, 2 A

0

10

20

30

40

50

60

70

80

90

100

110

120

130

140

150

160

170

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170

(W)

100

(W)

Page 53: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7.5

7-10

ON OFF

(°C)

CF

ON OFF

CTUVUSUL 60601-1 CAN/CSA

22.2 601.1 M90

Page 54: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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7.6

21860T

Page 55: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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8.0

8.1

8-1

D01 Low Impedance

50 25

D02 High Impedance (150 300 )

DIP

D03 Limit Exceeded

V > 1.1 x Vmax I > 1.1 x Imax

P > 1.2 x Pmax BSC D04 Temp Above

Set Point 5 C 4

D05 Excessive Temperature

95 C 1

D06 Sensor Failure – Replace Catheter

<20°C +/- 2 C >120°C +/- 5 C

)

D07 Temp Out Of Range

19.5°C 43.5°C

30

RF ON

READY ( )

D08 Check Pod

Pod

BSC D09 MultiSense

Sensor Failure BSC

D10 Replace Catheter Invalid ID

ID

D11 Check Remote Control Panel

Remote Control

Remote ControlBSC

Page 56: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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9.0

9.1 Boston Scientific Corporation (BSC)

BSC12

BSC BSC

BSC

BSC

BSC BSCBSC

BSC

BSC

Page 57: Operator’s Manual, 100 - Boston Scientific...EPT-012 Maestro 3000TM Cardiac Ablation System Operator’s Manual, 100 Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455

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9.2

Boston Scientific Corporation

9.3

Boston Scientific CorporationBoston Scientific Corporation Boston Scientific CorporationBoston Scientific Corporation

Boston Scientific Corporation

One Boston Scientific Place

Natick, MA 01760-1537

USA

© 2011 Boston Scientific Corporation or its affiliates. All rights reserved.

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EPT-012