Boston Scientific Maestro 4000 Instruction Manual

CONNECTIONS GUIDE
EP-305104-AA MAR2015

CONNECTIONS GUIDE
1Cheat Sheet Connections
2 Blazer™II/Blazer Prime™4mm
2.1 Maestro 4000™
2.2 Maestro 3000™
3 Blazer™II / Prime™XP 8/10 mm
3.1 Maestro 4000™
3.2 Maestro 3000™
4 Chilli II™
4.1 Maestro 4000™
4.2 Maestro 3000™
5Blazer™Open-Irrigated
5.1 Maestro 4000™
5.2 Stockert
5.3 IBI
6IntellaTip MiFi™XP
6.1 Maestro 3000™set up
6.2 Maestro 4000™set up
6.3 Maestro 3000™/4000™with EnSite™Velocity™
6.3.1 Basic EnSite™Velocity™
6.3.2 Advanced EnSite™Velocity™
6.4 Connection Guide & IBI 18
6.5 Connection Guide & Stockert
1
3
4
4
6
6
6
5
5
7
9
10
12
13
17
15
18

CONNECTIONS GUIDE
8 Maestro 3000™ guide
9 CircuCool™ Instructions
10 Maestro 4000™
10.1 Controller Setup
10.2 Troubleshooting Guide
10.3 Diagnostic Messages Card
10.4 Operational Messages Card
11 MetriQ™
11.1 Set up
11.2 Messages Card
21
27
33
35
37
39
41
43
CONNECTIONS GUIDE
8Maestro 3000™guide
9 CircuCool™Instructions
10 Maestro 4000™
10.1 Controller Setup
10.2 Troubleshooting Guide
10.3 Diagnostic Messages Card
10.4 Operational Messages Card
11 MetriQ™
11.1 Set up
11.2 Messages Card
2
20
26
32
34
36
38
40
42

CATHETER GENERATOR CONNECTOR
MAX
POWER
GROUND PAD
UNITS
GROUND PAD CABLE
ADAPTER PUMP TUBING SET
FLUID INFUSION SPEED (ml/min)
no RF/< 30 W/30-50 W
FLUID FOR
INFUSION
MAESTRO 3K 651/613 100 1 Valley lab directly to gen - - - -
MAESTRO 4K 651/613 100 1 Valley lab directly to gen - - - -
STOCKERT 115^^ 100 1 39D82X0** - - - -
IBI1500T 1684TH*+613/651 100 1 Valley lab directly to gen - - - -
MAESTRO 3K 651/613 150 2 Valley lab directly to gen - - - -
MAESTRO 4K 651/613 150 2 Valley lab directly to gen - - - -
STOCKERT 115^^ 100 2 39D82X0**+ E0507B^ - - - -
IBI1500T 1684TH*+613/651 150 2 Valley lab directly to gen - - - -
MAESTRO 3K 620 150 2 Valley lab directly to gen - - - -
MAESTRO 4K 620 150 2 Valley lab directly to gen - - - -
STOCKERT 620+115^^ 100 2 39D82X0**+ E0507B^ - - - -
IBI1500T 1684TH*+620 150 2 Valley lab directly to gen - - - -
MAESTRO 3K 681 50 1 Valley lab directly to gen CIRCUCOOL 352104 36 (fixed) 5% Dextrose
MAESTRO 4K 681 50 1 Valley lab directly to gen CIRCUCOOL 352104 36 (fixed) 5% Dextrose
STOCKERT - - - - - - -
MAESTRO 3K - - - - - - -
MAESTRO 4K 671 50 1 Valley lab directly to gen METRIQ 117 2/17/30 saline
STOCKERT 691 50 1 39D82X0** COOLFLOW 116 or BW tubing set 2/17/30 saline
IBI 1500T 100-339 ADAPTOR + 691 50 1 Valley lab directly to gen COOL POINT SJ tubing set 2/17/30 saline
*Provided by SJM
**Provided by BW
^Provided by Covidien
^^115 is BSC reference, also provided by BW with their own reference (16384)
BLAZER II/PRIME
4 mm
BLAZER II/PRIME XP
8/10 mm
MIFI XP
CHILLI II
BLAZER OI
3
IntellaTip MiFi™XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a
physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device.
Information for the use only in countries with applicable health authority product registrations.
3

Maestro 4000™ Cardiac Ablation System
Connection Guide
Maestro 4000™Controller to:
Blazer™II XP Catheter
Blazer Prime™XP Catheter
Maestro 4000™Controller to:
Blazer™II Temperature Ablation Catheter
Blazer™II Temperature Ablation Catheter
Blazer Prime™Temperature Ablation Catheter
Power
Power
Temp
Average Maximum Clear
Control
Panel
Power Temp Impedance
Impedance Time
Counter
TotalTime
Mem
Mem
Mem
Mem
Mem
12345
View
Settings
Temperature
RF Power Control
Generator Ren
RPM
TM
Indifferent
Electrode
Indifferent
Electrode
STD/XP
Ground Pad
M004 354 0
Ground Pad
M004 354 0
Cable: Pod to Recorder
M004 653S 0
Cable: Pod to Catheter
M004 651 0 or M004 613 0
Power
Power
Temp
Average Maximum Clear
Control
Panel
Power Temp Impedance
Impedance Time
Counter
Total
Time
Mem
Mem
Mem
Mem
Mem
12345
View
Settings
Temperature
RF Power Control
Generator Ren
RPM
TM
Indifferent
Electrode
Indifferent
Electrode
STD/XP
Cable: Pod to Recorder
M004 653S 0
Ground Pad
M004 354 0
Cable: Pod to Catheter
M004 651 0 or M004 613 0
4
IntellaTip MiFi™XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
Maestro 4000™
Cardiac Ablation System
Connection Guide
4

Maestro 4000™Controller to:
Chilli II™Cooled Ablation Catheter
Cable: Pod to Recorder
M004 653S 0
Cable: Pod to Catheter M004 681 0
Ground Pad
M004 354 0
Tubing Kit
M004 352104 0
Power
Power
Temp
Average Maximum Clear
Control
Panel
Power Temp Impedance
Impedance Time
Counter
Total
Time
Mem
Mem
Mem
Mem
Mem
12345
Vie
w
Settings
Temperature
RF P
ower Control
Generator Ren
RPM
TM
Indifferent
Electrode
Indifferent
Electrode
TP
Sterile, normal (0.9%), heparinized
(1 u heparin/ml) saline
MetriQ™ Irrigation Pump
Tubing Set
M004 117 0
Blazer Open Irrigated
Ablation Catheter
Blazer OI Pod to Catheter
Cable M004 671 0
Ground Pad
M004 354 0
Communication Cable
M004 661 0
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sales by or on the
order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling
supplied with each device. Information for the use only in countries with applicable health authority product registrations.
EP-252704-AA JUN2014 Printed in Germany by medicalvision.
www.bostonscientific.com
© 2014 Boston Scientific Corporation
or its affiliates. All rights reserved.
DINEP2215EA
Maestro 4000™ Controller to:
Blazer™Open-Irrigated Ablation Catheter
5
IntellaTip MiFi™XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
5

Maestro 3000 Controller to:
Blazer™ II Temperature Ablation Catheter
Blazer™ II HTD Temperature Ablation Catheter
Blazer Prime™ HTD Temperature Ablation Catheter
Maestro 3000 Controller to:
Blazer™ II XP Temperature Ablation Catheter
Blazer Prime™ XP Temperature Ablation Catheter
Ground Pad
M004 354 1
Cable: Pod to Catheter
M004 651 0 or M004 613 0
Cable: Pod to Recorder
M004 653S 0
Cable: Pod to Recorder
M004 653S 0
Ground Pad
M004 354 1
Ground Pad
M004 354 1
Cable: Pod to Catheter
M004 651 0 or M004 613 0
Maestro 3000 Controller to:
Chilli II™ Cooled Ablation Catheter
Cable: Pod to Recorder
M004 653S 0
Ground Pad
M004 354 1
Cable: Pod to Catheter M004 681 0
Tubing Kit
M004 352104 0
Maestro 3000™ Cardiac Ablation System
EP Cat 2013_inners_blueband_EP INNERS2012.qxd 11/04/2013 11:39 Page 4
6
IntellaTip MiFi™XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
Maestro 3000™
Cardiac Ablation System
6

Blazer™Open-Irrigated Ablation Catheter with
Compatible Generator and Pump
Product illustrations designed by Boston Scientific, not actual photos.
The Blazer Open-Irrigated Ablation Catheter has been tested and verified to operate safely with the
Stockert Radiofrequency Generator and Biosense Webster CoolFlow®Irrigation Pump. Data on file.
Sterile, normal (0.9%),
heparinized (1 u heparin/ml) saline
Stockert
Radiofrequency
Generator
Global Port Digital
ECG Connection Cable
Stockert
Global Port
Serial Computer
Interface Cable D-type
Biosense Webster
CoolFlow Irrigation Pump
Biosense Webster
CoolFlow Irrigation
Tubing Set
Blazer™Open-Irrigated
Ablation Catheter
Model 691 Cable
EGM Connection
Cable
Dispersive Indifferent Patch
Biosense Webster
Stockert CoolFlow
Pump Interface Cable
CoolFlow is a trademark of Cordis Corporation.
The Blazer™Open-Irrigated Ablation Catheter requires a generator, pump and tubing system
able to deliver 1W to 50W of power and irrigation flow to the catheter cooling lumen of
2ml/min during standby and 17-30 ml/min during RF delivery.
8
IntellaTip MiFi™XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
Blazer™Open-Irrigated
Ablation Catheter
with Compatible Generator and Pump
7

Irrigation Flow Recommendations
The Stockert Radiofrequency Generator Operation:
•Select Catheter Type ‘THERMO-COOL’
•Confirm the ‘CoolFlow Cut-Off’ is set to 50° C (generator default)
•Set the initial power level to 15-20W
•Maximum power of 50W
•Power may be increased by 5-10W increments as needed
Power (W) Irrigation Flow Rate (ml/min)
Mapping/
Standby 0 2
Ablation ≤30 17
31-50 30
The Blazer™Open-Irrigated Ablation Catheter requires a generator, pump and tubing system
able to deliver 1W to 50W of power and irrigation flow to the catheter cooling lumen of
2ml/min during standby and 17-30 ml/min during RF delivery.
Blazer™Open-Irrigated Ablation Catheter with
Compatible Generator and Pump
•Initiate a higher flow rate (17ml/min) up to 5 seconds prior to start of RF delivery. Maintain high
flow 2-5 seconds after RF delivery terminates and then adjust accordingly.
•The application of RF energy must not be initiated until the increase in irrigation flow rate is
confirmed by at least a 2º C decrease.
© 2010 Boston Scientific Corporation
or its affiliates. All rights reserved.
DINEP2156EA
www.bostonscientific-international.com
Valleylab is a trademark of Covidien AG Corporation.
CoolFlow is a trademark of Cordis Corporation.
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a
physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device.
Information for the use only in countries with applicable health authority product registrations.
PSST IC 6390 Printed in Germany by medicalvision.
9
Irrigation Flow Recommendations
The Stockert Radiofrequency Generator Operation:
•Select Catheter Type ‘THERMO-COOL’
•Confirm the ‘CoolFlow Cut-Off’ is set to 50° C (generator default)
•Set the initial power level to 15-20W
•Maximum power of 50W
•Power may be increased by 5-10W increments as needed
Power (W) Irrigation Flow Rate (ml/min)
Mapping/
Standby 0 2
Ablation ≤30 17
31-50 30
The Blazer™Open-Irrigated Ablation Catheter requires a generator, pump and tubing system
able to deliver 1W to 50W of power and irrigation flow to the catheter cooling lumen of
2ml/min during standby and 17-30 ml/min during RF delivery.
Blazer™Open-Irrigated Ablation Catheter with
Compatible Generator and Pump
•Initiate a higher flow rate (17ml/min) up to 5 seconds prior to start of RF delivery. Maintain high
flow 2-5 seconds after RF delivery terminates and then adjust accordingly.
•The application of RF energy must not be initiated until the increase in irrigation flow rate is
confirmed by at least a 2º C decrease.
© 2010 Boston Scientific Corporation
or its affiliates. All rights reserved.
DINEP2156EA
www.bostonscientific-international.com
Valleylab is a trademark of Covidien AG Corporation.
CoolFlow is a trademark of Cordis Corporation.
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a
physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device.
Information for the use only in countries with applicable health authority product registrations.
PSST IC 6390 Printed in Germany by medicalvision.
9
IntellaTip MiFi™XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
Blazer™Open-Irrigated
Ablation Catheter
with Compatible Generator and Pump
8

BlazerTM Open-Irrigated
Ablation Catheter - Connectivity to IBI generator
MedFact Connect
Adapter Cable
Blazer OI
Connector cable
Blazer OI
Catheter Model
IBI Generator Model
Catalog Number 100-339 M0046910 EPT9620K2 (Large)
EPT9620 (Standard)
EPT9620N4 (Asymmetric)
1500T11
Adaptor List Price € 300 per box (€ 150 each), 2 nonsterile units per box, minimum order 1 box
© 2013 Boston Scientic Corporation
or its afliates. All rights reserved.
DINEP2201EB
www.bostonscientific-international.com
All cited trademarks are the property of their respective owners.
CAUTION: The law restricts these devices to sales by or on the order
of a physician. Indications, contrain-dications, warnings and instructions
for use can be found in the product labeling supplied with each device.
Information for the use only in countries with applicable health
authority product registrations.
EP-197002-AB OCT 2013 Printed in Germany by medicalvision.
Contact Information:
Phone: [phone]
Email: of[email protected]
10
BlazerTM Open-Irrigated
Ablation Catheter - Connectivity to IBI generator
MedFact Connect
Adapter Cable
Blazer OI
Connector cable
Blazer OI
Catheter Model
IBI Generator Model
Catalog Number 100-339 M0046910 EPT9620K2 (Large)
EPT9620 (Standard)
EPT9620N4 (Asymmetric)
1500T11
Adaptor List Price € 300 per box (€ 150 each), 2 nonsterile units per box, minimum order 1 box
© 2013 Boston Scientic Corporation
or its afliates. All rights reserved.
DINEP2201EB
www.bostonscientific-international.com
All cited trademarks are the property of their respective owners.
CAUTION: The law restricts these devices to sales by or on the order
of a physician. Indications, contrain-dications, warnings and instructions
for use can be found in the product labeling supplied with each device.
Information for the use only in countries with applicable health
authority product registrations.
EP-197002-AB OCT 2013 Printed in Germany by medicalvision.
Contact Information:
Phone: [phone]
Email: of[email protected]
10
Blazer™Open-Irrigated
Ablation Catheter
Connectivity to IBI generator
9