Boston Scientific Maestro 4000, Maestro 3000 Connection Manual

Page 1
CONNECTIONS GUIDE
EP-305104-AA MAR2015
Page 2
CONNECTIONS GUIDE
1 Cheat 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
5 Blazer™ Open-Irrigated
5.1 Maestro 4000™
5.2 Stockert
5.3 IBI
6 IntellaTip 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
3
4
4
6
6
6
5
5
7
9
10
12
13
17
15
18
Page 3
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
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
20
26
32
34
36
38
40
42
Page 4
CATHETER GENERATOR CONNECTOR
MAX
POWER
GROUND PAD
UNITS
GROUND PAD CABLE
ADAPTER PUMP TUBING SET
FLUID INFUSION SPEED (ml/mi n)
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 (fi xed) 5% Dextrose MAESTRO 4K 681 50 1 Valley lab directly to gen CIRCUCOOL 352104 36 (fi xed) 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 tubi ng set 2/17/30 saline
*Provided by SJM **Provided by BW ^Provided by Covidien ^^115 is BSC reference, also provi ded 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
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.
Page 5
Maestro 4000Cardiac 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
1
2
3
4
5
View
Settings
Temperature
RF Power Control
Generator Ren
RPM
TM
Indiff
erent
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
1
2
3
4
5
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
Maestro 4000™
Cardiac Ablation System
Connection Guide
Page 6
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
1
2
3
4
5
Vie
w
Settings
Temperature
RF P
ower Control
Generator Ren
RPM
TM
Indifferent Electrode
In
d iff e re
n t
E
le c tro d
e
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 ci ted trademar ks are the prop erty of t heir respe ctive owners. C AUTION : The law res tricts t hese devices to sales b y or on the order o f a physicia n. Indicat ions, cont raindications, war nings and instructions for u se can be foun d in the prod uct labeli ng suppli ed with each de vice. Inf ormation f or the use only i n countries w ith applica ble healt h authority produ ct regis trations.
EP-2 5270 4-AA JU N2014 Pr inted in Ge rmany by medicalvisio n.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2215EA
Maestro 4000™ Controller to: Blazer
Open-Irrigated Ablation Catheter
Page 7
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
6
Maestro 3000™
Cardiac Ablation System
Page 8
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.
Blazer™ Open-Irrigated
Ablation Catheter
with Compatible Generator and Pump
Page 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
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.
Blazer™ Open-Irrigated
Ablation Catheter
with Compatible Generator and Pump
Page 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
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: +49 (0)7621-579 820 Email: ofce@medfact.eu
Blazer™ Open-Irrigated
Ablation Catheter
Connectivity to IBI generator
Page 11
IntellaTip MiFi XP
System Set Up
Step 1. Connecting the Catheter to the Filter Module and Pod with the M0046200 Cable
a. Connect yellow cable plug into the port marked “Catheter Cable” on the Filter Module b. Connect the red cable plug into the center port marked “STD/XP on the Pod c. Connect the black cable plug into the IntellaTip MiFi XP Catheter
Step 2. Connecting the Filter Module to the Recording System with the M004 653S 0 Cable
a. Connect the M004 653S 0 Cable cable plug into the green port marked “Recording
System” on the Filter Module. Connect the second M004 653S 0 Cable to Pod
b. Connect the 3 Mini Electrodes (ME’s) via the three pins D, 2, and 3 to the Catheter
Pin Connection Box. Pin 4 is not used.
Step 3. Connecting the Pod to the Recording System with the M004 653S 0 Cable
a. Connect the M004 653S 0 Cable plug to the Pod b. Connect the conventional bipoles via the pins 1, 2, 3 and 4 to the Catheter Pin
Connection Box
Step 4. Connecting the Pod to the Filter Module
a. Connect the shrouded pin-end (2mm shrouded pin) of Reference Cable to the port marked “Reference Cable” on the Filter Module b. Connect the 2 prong plug end of the Reference Cable to the Dispersive Indifferent Patch (DIP) port on the Pod c. Connect the DIP to the 2-prong socket end of the Reference Cable d. Connect 1 additional DIP directly to the remaining port marked “Indifferent Electrode” on the Pod
CATHETER PIN CONNECTION BOX
Cable M004 653S 0
(Yellow)
Cable:
Dispersive Indifferent Patch (Commercially Available)
IntellaTip MiFi Filter Module
(Green)
(2mm Shrouded Pin)
IntellaTip MiFi XP Cable
Maestro 3000 Cardiac Ablation Controller
Cable:
Dispersive Indifferent Patch
(Commercially Available)
RF Ablation Pod
IntellaTip MiFi XP Catheter
Reference Cable:
Step 3
Filter Module to RF Pod
(Black)
(Red)
Step 1
Step 2
Step 4
M004 653S 0
M004 21860T 0
M004 3636 0
M004 620 0
M004 653S 0
M004 1212 0
11
IntellaTip MiFi™ XP
Temperature Ablation Catheter
System Set Up
Page 12
Unparalleled Clarity
Filter Module
Reference Cable
Catheter Cable
IntellaTip MiFi XP
Temperature Ablation Catheter Product Specification
Bidirectional Curve Options
Standard Radius Curve
Large Radius Curve (K2)
Asymmetrical-4 Curve (N4)
Electrode Configuration: Quadripolar Electrode Spacing: 2.5 mm Indicated for use with an 8.5F sheath
Catheter Model No. Shaft Size Tip Size Curve Style Cable Model No.
M004 EPM4500 0 7F 8F/8 mm (straight) Standard M004 620 0
M004 EPM4500K2 0 7F 8F/8 mm (straight) Large M004 620 0
M004 EPM4500N4 0 7F 8F/8 mm (straight) Asymmetric-4 M004 620 0
M004 EPM4790 0 7F 8F/10 mm (straight) Standard M004 620 0
M004 EPM4790K2 0 7F 8F/10 mm (straight) Large M004 620 0
M004 EPM4790N4 0 7F 8F/10 mm (straight) Asymmetric-4 M004 620 0
Cables and Accessories
Model No. Description
M004 1212 0 Filter Module (reference cable included)
M004 3636 0 Reference Cable from Filter Module to Pod (32 in)
M004 620 0 Cable from Catheter to Pod and to Filter Module (10 ft)
M004 653S 0 Cable from Filter Module or Pod to Recorder (2 required)
7 F = 2.33 mm 8 F = 2.66 mm 8.5 F = 2.83 mm
IntellaTip MiFiXP Temperature Ablation Catheter
Unparalleled Clarity
Valleylab is a trademark of Covidien AG 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.
Information contained herein is for distribution outside the U.S. only. Illustrations for information purposes – not indicative of actual size or clinical outcome.
EP177405-AA AUG13 Printed in Germany by medicalvision.
Filter Module
Reference Cable
Catheter Cable
IntellaTip MiFi XP
Temperature Ablation Catheter Product Specification
www.bostonscientific-international.com
© 2013 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2200EA
Bidirectional Curve Options
Standard Radius Curve
Large Radius Curve (K2)
Asymmetrical-4 Curve (N4)
Electrode Configuration: Quadripolar Electrode Spacing: 2.5 mm Indicated for use with an 8.5F sheath
Catheter Model No. Shaft Size Tip Size Curve Style Cable Model No.
M004 EPM4500 0 7F 8F/8 mm (straight) Standard M004 620 0
M004 EPM4500K2 0 7F 8F/8 mm (straight) Large M004 620 0
M004 EPM4500N4 0 7F 8F/8 mm (straight) Asymmetric-4 M004 620 0
M004 EPM4790 0 7F 8F/10 mm (straight) Standard M004 620 0
M004 EPM4790K2 0 7F 8F/10 mm (straight) Large M004 620 0
M004 EPM4790N4 0 7F 8F/10 mm (straight) Asymmetric-4 M004 620 0
Cables and Accessories
Model No. Description
M004 1212 0 Filter Module (reference cable included)
M004 3636 0 Reference Cable from Filter Module to Pod (32 in)
M004 620 0 Cable from Catheter to Pod and to Filter Module (10 ft)
M004 653S 0 Cable from Filter Module or Pod to Recorder (2 required)
7 F = 2.33 mm 8 F = 2.66 mm 8.5 F = 2.83 mm
IntellaTip MiFiXP Temperature Ablation Catheter
IntellaTip MiFi™ XP
Temperature Ablation Catheter
Product Specification
Page 13
Maestro 4000 Cardiac Ablation System
IntellaTip MiFiXP Temperature Ablation Catheter - System Setup
Maestro 4000 Controller to: IntellaTip MiFi XP Catheter
Step 1. Connecting the Catheter to the Filter Module and Pod with the M004 620 0 Cable
a. Connect yellow cable plug into the port marked “Catheter Cable” on the Filter Module b. Connect the red cable plug into the center port marked “STD/XP” on the Pod c. Connect the black cable plug into the IntellaTip MiFi XP Catheter
Step 2. Connecting the Filter Module to the Recording System with the M004 653S 0 Cable
a. Connect the M004 653S 0 Cable cable plug into the green port marked “Recording
System” on the Filter Module. Connect the second M004 653S 0 Cable to Pod
b. Connect the 3 Mini Electrodes (ME’s) via the three pins D, 2 and 3 to the Catheter Pin
Connection Box. (Pin 4 is not used)
Step 3. Connecting the Pod to the Recording System with the M004 653S 0 Cable
a. Connect the M004 653S 0 Cable plug to the Pod b. Connect the conventional bipoles via pins 1, 2, 3 and 4 to the Catheter Pin Connection Box
Step 4. Connecting the Pod to the Filter Module
a. Connect the shrouded pin-end (2mm shrouded pin) of Reference Cable to the port marked “Reference Cable” on the
Filter Module b. Connect the 2 prong plug end of the Reference Cable to the Dispersive Indifferent Patch (DIP) port on the Pod c. Connect the DIP to the 2-prong socket end of the Reference Cable d. Connect 1 additional DIP directly to the remaining port marked “Indifferent Electrode” on the Pod
CATHETER PIN CONNECTION BOX
Cable M004 653S 0
(Yellow)
Cable: M004 653S 0
Dispersive Indifferent Patch (Commercially Available)
IntellaTip MiFi Filter Module M004 1212 0
(Green)
(2mm Shrouded Pin)
IntellaTip MiFi XP Cable
M004 620 0
Cable: M004 653S 0
Dispersive Indifferent Patch
(Commercially Available)
RF Ablation Pod
M004 4010 0
IntellaTip MiFi XP Catheter
Reference Cable:
Step 3
Filter Module to RF Pod M004 3636 0
(Black)
(Red)
Step 1
Step 2
Step 4
Maestro 4000 Cardiac Ablation Controller
Maestro 4000™
Cardiac Ablation System
IntellaTip MiFi™ XP Temperature Ablation Catheter - System Setup
Page 14
Step 1. Connecting the IntellaTip MiFi XP Conventional Bipoles as a standard ablation catheter
a. Connect Dispersive Surface Electrode(s) to the Velocity EPT GenConnect Module.
b. Connect M004 620 0 Cable to the Filter Module (yellow plug) and the Velocity EPT GenConnect (red plug) .
c. Connect the M004 620 0 Cable (black plug) into the IntellaTip MiFi XP Ablation Catheter.
d. Connect Dispersive Interconnect Cable (SJM 100010915) to the Maestro Pod Dispersive Pad Inputs.
e. Connect Catheter Interconnect Cable (SJM 100010397) to the Maestro Pod Catheter Input.
f. Connect the M004 653S 0 Cable into the Pod. Pin out conventional Bipoles into the Pin Connection Box.
Step 2. Connecting the IntellaTip MiFi XP Mini Electrodes as a separate diagnostic catheter
a. Connect the M004 653S 0 Cable plug into the green port marked “Recording System” on the Filter Module.
Connect the pins to the Catheter Pin Connection Box.
b. Pin out the Mini Electrodes (MEs) - D, 2 and 3. Pin 4 is not used, but can be plugged into any unused channel.
c. Do Not Connect the Reference Cable (M004 3636 0) when using the EnSite Velocity System.
(Green)
(Black)
(Yellow)
Velocity EPT GenConnect
Catheter Pin Connection Box
Pannel on the front
of the Amplifier
IntellaTip MiFi Filter Module M004 1212 0
IntellaTip MiFi XP Catheter
Maestro 3000 Cardiac
TM
Ablation Controller
RF Ablation Pod
M004 21860T 0
Dispersive Indifferent Patch (Commercially Available)
IntellaTip MiFi XP Cable M004 620 0
M004 653S 0
Cable: Filter Module to Recorder
(Red)
Cable: Pod to Recorder
M004 653S 0
Do Not Connect the Reference Cable
IntellaTip MiFi XP Ablation Catheter
Basic Set Up with Ensite Velocity Cardiac Mapping System
IntellaTip MiFi™ XP
Ablation Catheter
Basic Set Up with Ensite™ Velocity™ Cardiac Mapping System
Page 15
In catheter set up mode
unclick the Mini Electrodes
Disable visualization
on the Mini Electrodes
A
Step 3. Defining the IntellaTip MiFi XP Ablation Catheter Parameters
a. The IntellaTip MiFi Catheter should be defined as both an ablation (ABL) and diagnostic (MIFI) catheter in the
Catheter Set Up Screen.
b. Input waveforms: D-2, 2-3 and 3-D, for the IntellaTip MiFi XP Ablation Catheter Mini Electrodes.
NAME ABL MIFI
Electrodes
4 3
Type:
Ablation Diagnostic
Diameter:
8 Fr
(2.67 mm)
8 Fr
(2.67 mm)
Distal Length:
8/10 mm 1 mm
Electrode Length:
1.27 mm 1 mm
Electrode Spacing:
2.5-2.5-2.5 1-1
IntellaTip MiFi XP Ablation Catheter
Basic Set Up with Ensite Velocity Cardiac Mapping System
In catheter set up mode
unclick the Mini Electrodes
Disable visualization
on the Mini Electrodes
A
Step 3. Defining the IntellaTip MiFi XP Ablation Catheter Parameters
a. The IntellaTip MiFi Catheter should be defined as both an ablation (ABL) and diagnostic (MIFI) catheter in the
Catheter Set Up Screen.
b. Input waveforms: D-2, 2-3 and 3-D, for the IntellaTip MiFi XP Ablation Catheter Mini Electrodes.
NAME ABL MIFI
Electrodes
4 3
Type:
Ablation Diagnostic
Diameter:
8 Fr
(2.67 mm)
8 Fr
(2.67 mm)
Distal Length:
8/10 mm 1 mm
Electrode Length:
1.27 mm 1 mm
Electrode Spacing:
2.5-2.5-2.5 1-1
IntellaTip MiFi XP Ablation Catheter
Basic Set Up with Ensite Velocity Cardiac Mapping System
www.bostonscientific.eu
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2227EA
IntellaTip MiFi XP is a registered trademark of Boston Scientific or its affiliates. All other trademarks are property of their respective owners.
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 labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations.
Information not intended for distribution in France.
EP-283103-AA DEC2014 Printed in Germany by medicalvision.
IntellaTip MiFi™ XP
Ablation Catheter
Basic Set Up with Ensite™ Velocity™ Cardiac Mapping System
Page 16
IntellaTip MiFi XP Ablation Catheter
Advanced Set Up with Ensite™ Velocity™ Cardiac Mapping System
Step 1. Connecting the IntellaTip MiFi XP Conventional Bipoles as a standard ablation catheter
a. Connect Dispersive Surface Electrode(s) to the Velocity EPT GenConnect Module. b. Connect M004 620 0 Cable to the Filter Module (yellow plug) and the Velocity EPT GenConnect (red plug). c. Connect the M004 620 0 Cable (black plug) into the IntellaTip MiFi XP Catheter. d. Connect Dispersive Interconnect Cable (SJM 100010915) to the Maestro Pod Dispersive Pad Inputs. e. Connect Catheter Interconnect Cable (SJM 100010397) to the Maestro Pod Catheter Input. f. Connect the M004 653S 0 Cable into the Pod. Pin out conventional Bipoles into the Pin Connection Box
Step 2. Connecting the IntellaTip MiFi XP Mini Electrodes as a separate diagnostic catheter
a. Connect the M004 653S 0 Cable plug into the green port marked “Recording System” on the Filter Module.
Connect the pins to the Catheter Pin Connection Box. b. Pin out the Mini Electrodes (MEs) - D, 2 and 3. Pin 4 is not used, but can be plugged into any unused channel. c. Do Not Connect the Reference Cable (M004 3636 0) when using the EnSite Velocity System.
Step 3. Defining the IntellaTip MiFi XP Catheter Parameters
a. The IntellaTip MiFi Catheter should be defined as both an ablation (ABL) and diagnostic (MIFI) catheter in the
Catheter Set Up Screen. b. Input waveforms: D-2, 2-3 and 3-D, for the IntellaTip MiFi XP Catheter Mini Electrodes.
(Green)
(Black)
(Yellow)
Velocity EPT GenConnect
Catheter Pin Connection Box
Pannel on the front
of the Amplifier
IntellaTip MiFi Filter Module
M004 1212 0
IntellaTip MiFi XP Catheter
Maestro 3000 Cardiac Ablation Controller
RF Ablation Pod
M004 21860T 0
Dispersive Indifferent Patch (Commercially Available)
IntellaTip MiFi XP Cable M004 620 0
M004 653S 0
Cable: Filter Module to Recorder
(Red)
Cable: Pod to Recorder
M004 653S 0
NAME ABL MIFI
Electrodes
4 3
Type:
Ablation Diagnostic
Diameter:
8 Fr
(2.66 mm) 8 Fr (2.66 mm)
Distal Length:
8/10 mm 1 mm
Electrode Length:
1.27 mm 1 mm
Electrode Spacing:
2.5-2.5-2.5 1-1
IntellaTip MiFi™ XP
Ablation Catheter
Advanced Set Up with Ensite™ Velocity™ Cardiac Mapping System
Page 17
IntellaTip MiFi XP is a registered trademark of Boston Scientific or its affiliates. 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.
Information contained herein is for distribution outside the U.S. only. Illustrations for information purposes – not indicative of actual size or clinical outcome.
EP-238913-AA APR2014 Printed in Germany by medicalvision.
www.bostonscientific-international.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2206EA
IntellaTip MiFi XP Ablation Catheter
Advanced Set Up with Ensite™ Velocity™ Cardiac Mapping System
Enable visualization
on the Mini Electrodes
Before mapping, create a model with the Conventional Bipoles
Mapping with Mini Electrodes Point by Point Data Review
a) In the Collection Control Panel under
“Roving Source” select MIFI and ALL
b) Ensure to click “show all roving waves”
c) In the Filters Control Panel select
the desired filter settings
In catheter set up mode verify
the Mini Electrodes are selected
A
B
C D
Select the highest voltage Mini Electrode pair for each collection location
IntellaTip MiFi™ XP
Ablation Catheter
Advanced Set Up with Ensite™ Velocity™ Cardiac Mapping System
Page 18
Mifi XP with SJM IBI T1500 T9
IntellaTip MiFi XP
620 cable
3636 cable
First 354 ValleyLab ground pad
SJM IBI T1500 T9
SJM 1684 TH Adaptor cable*
653S cable
*Must be ordered directly through SJM by the hospital. Cannot be provided by BSC.
Second 354 ValleyLab ground pad
18
IntellaTip MiFi™ XP
Temperature Ablation Catheter
with SJM IBI T1500 T9
Page 19
Step 3. Connecting the Generator to the Recording System with the M004 653S 0 Cable
Step 4. Connecting the Generator to the Filter Module
Step 1. Connecting the Catheter to the Filter Module and Pod with the M00 4620 0 Cable
a. Connect the black 620 cable plug into the IntellaTip MiFi XP Ablation Catheter b. Connect the red 620 cable with the 115 cable c. Connect the red 115 cable to the front port marked “Catheter” on the generator d. Connect the yellow 620 cable plug into the port marked “Catheter Cable” on the Filter Module
Step 2. Connecting the Filter Module to the Recording System with the M004 653S 0 Cable
a. Connect the M004 653S 0 Cable plug into the green port marked “Recording System”
on the Filter Module. Connect the second M004 653S 0 Cable to Pod
b. Connect the 3 Mini Electrodes (ME’s) via the three pins D, 2, and 3 to the Catheter Pin
Connection Box. Pin 4 is not used.
a. Connect the M004 653S 0 Cable plug to the Generator b. Connect the conventional bipoles via the pins 1, 2, 3 and 4 to the Catheter Pin Connection Box
a. Connect the shrouded pin-end (2mm shrouded pin) of Reference Cable to the port marked “Reference Cable” on the front
of the Filter Module
b. Connect the 2 prong plug end of the Reference Cable to the Dispersive Indifferent Patch (DIP) c. Connect the 2 prong plug end of the Reference Cable to 39D82X Reference cable (required with Valley Lab DIP) d. Connect the 39D82X Reference cable to the front of the Generator with ‘Blue’ plug which has the DIP symbol
CATHETER PIN CONNECTION BOX
Cable M004 653S 0
Global Port Digital ECG
Connection Cable
Stockert
Global Port
Serial Computer
Interface Cable D-type
EGM Connection
Cable
ValleyLab
Ground Pad
M004 354 0
Stockert EP-Shuttle
Radiofrequency Generator
IntellaTip MiFi™ XP Cable
M004 620 0
IntellaTip MiFi™ XP Cable
M004 115 0
IntellaTip MiFi™ XP
Ablation Catheter
Cable: Filter Module to Recorder
M004 653S 0
Reference Cable
M004 3636 0
Reference Cable
M004 39D82X 0
IntellaTip MiFi™ XP Filter Module
M004 1212 0
Cable: M004 653S 0
Step 2
(Red)
(Yellow)
(Green)
Reference Cable: Filter Module to RF Pod M004 3636 0
Step 4
IntellaTip MiFi XP Cable M004 620 0
Step 1
Cable: M004 653S 0
Step 3
In order to connect 2 ValleyLab® Ground Pads, adaptor EO5O7B (provided by Covidien) is needed.
IntellaTip MiFi XP Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
IntellaTip MiFi™ XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
Page 20
IntellaTip MiFi XP Ablation Catheter is indicated for use with an 8.5F (2.83 mm) sheath. All IntellaTip MiFi XP Ablation Catheters are 110 cm in length; distal shaft length is approximately 11 cm.
Unparalleled Clarity
Filter Module
Reference Cable
Catheter Cable
Bidirectional
Curve Options
Standard Radius Curve Large Radius Curve (K2) Asymmetric 4 Curve (N4)
Valleylab is a trademark of Covidien AG 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 labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information contained herein is for distribution outside the U.S only. Illustrations for information purposes – not indicative of actual size or clinical outcome.
EP_300901_AA MAR2015 Printed in Germany by medicalvision.
www.bostonscientific-international.com
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2234EA
Catheter Model No. Shaft Size Tip Size Curve Style Cable Model No.
M004 EPM4500 0 7F (2.33 mm) 8F (2.66 mm) /8mm (straight) Standard M004 620 0
M004 EPM4500K2 0 7F (2.33 mm) 8F (2.66 mm) /8mm (straight) Large M004 620 0
M004 EPM4500N4 0 7F (2.33 mm) 8F (2.66 mm) /8mm (straight) Asymmetric 4 M004 620 0
M004 EPM4790 0 7F (2.33 mm) 8F (2.66 mm) /10mm (straight) Standard M004 620 0
M004 EPM4790K2 0 7F (2.33 mm) 8F (2.66 mm) /10mm (straight) Large M004 620 0
M004 EPM4790N4 0 7F (2.33 mm) 8F (2.66 mm) /10mm (straight) Asymmetric 4 M004 620 0
M004 115 0 is a Boston Scientific UPN for this cable, also available by Biosense Webster as reference number 16384. In order to connect 2 ValleyLab® Ground Pads, adaptor EO5O7B (provided by Covidien) is needed.
Cables and Accessories
Model No. Description
M004 115 0 Stockert Cable to Blazer EPT Thermistor
M004 620 0 Catheter Cable to Pod and to Filter Module (10 ft)
M004 653S 0 Catheter Cable from Filter Module or Pod to recorder (2 required)
M004 1212 0 Filter Module (reference cable included)
M004 3636 0 Reference Cable from Filter Module to Pod (32 in)
System Set Up with Stockert EP-Shuttle RF Generator
IntellaTip MiFi XP Temperature Ablation Catheter
IntellaTip MiFi™ XP
Temperature Ablation Catheter
System Set Up with Stockert EP-Shuttle RF Generator
Page 21
Maestro 3000™
Cardiac Ablation System
Set Up and Trouble-Shooting Guide
Page 22
Note: This Guide is not intended to replace the Operators Manual.
Thoroughly review the Manual before installing or operating this system. Installation diagrams are shown in the Maestro 3000™ Cardiac Ablation System Operators Manual.
1) Connect a Hospital Grade power
cord from the rear panel of the Controller to a properly grounded AC wall outlet designated “Hospital Grade” or “Hospital Only.”
2) Connect patient monitoring
system cable to the recording system to display ablation parameters or to a computer, if GUI software is installed.
3) Optional: If the optional
footswitch is being used, connect it to the back panel of the Controller.
4) Connect recording system
cable (Model 653S) to the back of the Pod.
5) Connect the Pod cable to
the”Isolated Patient Connector” socket of the Controller front panel.
6) Receive the DIP electrode
cable(s) from the sterile field.
Maestro 3000™ Controller Front Panel Maestro 3000™ Controller Rear Panel
Pod Cable
On/Off Switch
Power Cord
Remote Control
Patient Monitoring System
Footswitch
Maestro 3000™
Cardiac Ablation System
Set Up Guide
Page 23
7) Install one DIP electrode (or two,
if using a high power catheter) into either (or both) of the “Indifferent Electrode” receptacles on the front of the Pod.
8) Receive the Catheter Cable from
the sterile field.
9) Connect Catheter Cable to the
front of the Pod.
10) Optional: If the Remote Control
Unit is used, connect a Hospital Grade power cord from the Remote Control Unit to a properly grounded AC wall outlet designated “Hospital Grade” or “Hospital Only.”
11) Optional: If the optional Remote
Control Unit is used, connect the Remote Control cable to the back panel of the Controller.
12) Optional: If the Remote
Control Unit is used, connect the cable from the Controller to the rear panel of the Remote Control Unit.
13) Turn on the Controller by pressing
the power switch on the front panel of the Controller to the “I” position.
Maestro 3000™
Cardiac Ablation System
Maestro 3000™ Controller
Maestro 3000™ Pod
Maestro 3000™ Remote Control Unit
Maestro 3000™
Cardiac Ablation System
Set Up Guide
Page 24
Alphanumeric Display Window
Maestro 3000™ System
Diagnostic Codes
The Maestro 3000™ Cardiac Ablation System will display diagnostic codes during STANDBY and DELIVER modes of operation. The code will appear in the Alphanumeric Display Window, located on the front panel of the System as shown above. Below is a description of the various diagnostic codes and the action to be taken to clear the code. These and complete operating instructions may be found in the Operators Manual.
Display Description Action
D01-Low Impedance Displayed impedance below the low Check all connections.
impedance threshold of 50Ω for a standard catheter and 25Ω when using a high power catheter.
D02-High Impedance Displayed impedance above the Check application of impedance setting (150Ω – 300Ω). DIP electrode. Check all
connections. Remove and inspect catheter.
D03-Limit Exceeded V > 1.1 x V
max
or I > 1.1 x I
max
Restart System.
or P > 1.2 x P
max.
Contact Boston Scientific if error recurs.
D04-Temp Above Set Point Displayed temperature is greater than Check set temperature. set point by at least 5°C for more than four seconds.
D05-Excessive Temperature Displayed temperature greater than 95°C Check catheter. for more than one second or measured Reduce power and/or temperature exceeds setting in set temperature. Power Control mode.
Maestro 3000™
Cardiac Ablation System
Trouble-Shooting Guide
Page 25
Display Description Action
D06-Sensor Failure Input temperature <20°C +/- 2°C Replace Catheter. Replace Catheter or >120°C +/- 5°C
(bad temp sensor or reference).
D07-Temp Out Of Range Attempt to enter RF Power On mode Ensure correct Catheter with a measured temperature outside the positioning. Check rangeof 19.5°C to 43.5°C or less than 30 measured temperature seconds have elapsed since last ablation in READY mode. and the temperature is above the set point.
D08-Check Pod Missing or bad pod connection. Check connections.
Restart system. Call Boston Scientific if error recurs.
D09-Replace Catheter Invalid catheter ID. Replace Catheter. Invalid ID
D10-Check Remote There is a communications problem Restart system. Check Control Panel between the Remote Control Unit connections. If error recurs,
and the Controller. disconnect Remote Control
Unit and contact Boston Scientific.
M01-Limited Output TEMPERATURE MODE: Maximum Check DIP electrode power is not sufficient to achieve the placement and desired temperature. However ablation application prior to will continue. continued delivery. POWER MODE: Maximum temperature is reached. RF power will be titrated down by the generator to avoid excessive temperature. HIGH Impedance
Maestro 3000™
Cardiac Ablation System
Trouble-Shooting Guide
Page 26
© 2006 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2096EA
Maestro 3000™ Cardiac Ablation System
Model Number Description
M004 21000TC 0 Maestro 3000™ Controller
M004 21870T 0 Maestro 3000™ Pod M004 21880 0 Maestro 3000™ Remote Control Unit (Optional)
Cables and Accessories
Model Number Description
M004 SVGA25 0 Remote Control Unit Cable, 7.5 m (25 ft) M004 SVGA50 0 Remote Control Unit Cable, 15.0 m (50 ft) M004 SVGA75 0 Remote Control Unit Cable, 22.5 m (75 ft) M004 681 0 Maestro 3000™ Pod to Chilli II™ Cable M004 21600 0 Maestro 3000™ Pod to PAM Cable M004 653S 0 Maestro 3000™ Pod to Recorder Cable M004 651 0 Maestro 3000™ Pod to Blazer™ Cable M004 354 0 Indifferent Electrode M004 21840 0 RF Ablation System Foot Switch (Optional)
Important: Cable to be ordered from EPMedSystems:
43-1684-0015 Cable Assembly, EP WorkMate with RPM™
Combination Catheter Interface Module to Maestro 3000™ Pod
Power Cords
Model Number Description Length
M004 ITPWRCORD 0 Powercord for use in Italy 250 cm M004 SWPWRCORD 0 Powercord for use in Switzerland 250 cm M004 UKPWRCORD 0 Powercord for use in the UK 250 cm M004 3536010 20 Powercord - Generic Europe 250 cm
Maestro 3000™
Cardiac Ablation System
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 3261 Printed in the UK by Comevent/Applemed. MAY 2006
Ordering Information
Page 27
Chilli II™
Cooled Ablation Catheter
CircuCool™
Fluid Circulation Pump
Set Up and Trouble-Shooting Guide
Page 28
1) Connect the Model 2071 TTT Box
to the Model 822T APM™ Device.
2) Turn the knob on the front of the
CircuCool Pump counterclockwise until loose and open the front of the occlusion bed.
3) Lift the latch handle and open
the occlusion bed.
4) Using sterile technique, hold the
catheter lumens on the bottom and connect and tighten the luers to the catheter luers.
5) Using sterile technique, connect
the sterile cable to the catheter.
6) Hand off the tubing set
to someone in a non-sterile field.
7) Hand off the catheter cable to
someone in a non-sterile field.
8) Connect catheter cable to
the TTT Box (model 2071). Turn on the TTT Box; verify “on” light is illuminated.
9) Insert the hard Peristaltic
tubing into the lower portion of the occlusion bed.
CircuCool™
Fluid Circulation Pump
Set Up Guide
Page 29
10) Slide the hard Peristaltic tubing
into the upper slot of the occlusion bed. Make sure the Peristaltic tubing is inside the occlusion bed.
11) Close the occlusion bed latch.
Make sure that the burette chamber is not distorted by the holder.
12) Close the door. Push the knob
in and turn it clockwise until snug. Ensure the burette chamber and pulse dampener are in their slots.
13) Using a syringe, place 30cc of
sterile normal saline 0.9% or D5W, into the burette chamber.
14) Check that the blue float seal is
floating, then turn on the pump.
15) As the system circulates,
the fluid level will drop. When it drops by 10cc, add an additional 10cc of sterile normal saline 0.9% or D5W.
The unit is ready to use.
16) Caution: Perform system integrity check. Always prime the
tubing prior to inserting the catheter into the patient.
CircuCool™
Fluid Circulation Pump
Set Up Guide
Page 30
Pump does not turn on
• Check that Power Cord is plugged into wall
• Check that Power Cord is connected properly to the back of the pump
• Check that Power Cord is not frayed or damaged
• Ensure that occlusion bed cover knob is engaged and tightened
• Ensure that occlusion bed latch is engaged
Lack of cooling effect or temperature is increasing
• Check tubing for leaks
• Check that tubing is not kinked or occluded
• Check catheter connection with tubing
• Check blue oat seal in burette (should be oating)
• Check the TTT box (model 2071) is turned on
• Check batteries of TTT box (model 2071) - may need to be replaced (2 each-9 volt)
• The TTT box (model 2071) may be faulty and may need to be replaced
• Check all cable connections
• The catheter sensor may be faulty, the catheter may need to be replaced
CircuCool™
Fluid Circulation Pump
Trouble-Shooting Guide
Page 31
Tubing is leaking
• Ensure catheter to tubing kit Luer tting is correctly connected
• Replace tubing set for all other leaks
There is fluid in burette, but no return fluid is seen dripping back into burette chamber
(you may see an impedance rise)
• Check that the tubing is not kinked or occluded
• Check that the catheter shaft is not kinked
Blue float seal is stuck on bottom of burette chamber
• Turn pump off rst
• Open the occlusion bed latch slightly, this should release the oat seal
• Check for leaks
• Ensure there is ~10 cc of uid in burette chamber when pump is on
“Knocking” sound
(Note: Pump makes a continuous audible churn, this is normal)
• Ensure tubing set is pulled taut inside the occlusion bed
• If knocking continues, change the tubing set
CircuCool™
Fluid Circulation Pump
Trouble-Shooting Guide
Page 32
© 2006 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2084EB
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 3086 Printed in the UK by Comevent/Applemed. JULY 2006
Chilli II™ Cooled Ablation Catheters
Catheter Length 110cm, Shaft 7.5F (2.5mm), Electrode Spacing 2.5mm, Quadripolar
Model Number Curve Option Distal Shaft Length Distal Tip Ø (F) / Length (mm)
M004 EPT9031 0 Standard Standard 7F/4mm (2.33mm)
M004 EPT9031K2 0 Large (K2) Standard 7F/4mm (2.33mm) M004 EPT9031N4 0 Asymmetric (N4) Standard 7F/4mm (2.33mm)
CircuCool™ Fluid Circulation Pump
Model Number Description
M004 8005 0 CircuCool™ Fluid Circulation Pump M00435 2104 0 CircuCool™ Tubing Set
Accessories
Model Number Description
Accessories for use with Maestro 3000™ Cardiac Ablation System
M004 21000TC 0 Maestro 3000™ Controller M004 21870T 0 Maestro 3000™ Pod M004 681 0 Cable to connect Chilli II™ Catheter to
Maestro 3000™ Pod
Accessories for use with EPT-1000XP™ Cardiac Ablation System
M004 805XP 0 EPT-1000XP™ Generator M004 EPT822T 0 APM High Power M0046 2062 0 Cable for Chilli II™ Catheter M004 2071 0 Thermocouple to Thermistor Translator
Universal Accessories
M004 613 0 Extension Thermistor Cable M004 651 0 Standard Thermistor Cable M004 354 0 Indifferent Electrode M004EPT6 2031 0 Adaptor for Osypka
and Medtronic Generators
M004EPT6 2068 0 Adaptor for Stockert Generator
CircuCool™
Fluid Circulation Pump
Chilli II™
Cooled Ablation Catheter
Ordering Information
Page 33
Maestro 4000Cardiac Ablation System
Controller Setup Guide
Note: This Guide is not intended to replace the Maestro 4000 Operator’s Manual. Thoroughly review the manual before installing or operating this system. Complete installation diagrams are shown in the manual. Not all components shown in this setup guide will be used with every system.
Maestro 4000 Controller Front Panel Maestro 4000 Controller Back Panel
Power Cord
Pod
Cable
On/Off
Switch
Pump Remote VolumeFoot Switch
Recording System
1) Connect EP Recording sys-
tem cable to the back panel of the Controller.
5) Optional: If a Remote Con­trol Unit is used, connect the Remote Control cable to the Remote Connector.
2) Connect a Hospital Grade power cord from the rear panel of the Controller to properly grounded AC wall outlet designated “Hospital Grade” or “Hospital Only”.
3) Optional: If the optional footswitch will be used, con­nect it to the Foot Switch Cable Connector.
4) Optional: If a MetriQ
Pump is used, connect the Pump cable to the Peristal­tic Pump Connector.
7) Connect the cable from the Controller to the rear of the Remote Control Unit.
6) Optional: If a Remote Con­trol Unit is used, connect a Hospital Grade power cord from the Remote Control Unit to a properly grounded AC wall outlet designated “Hospi­tal Grade” or “Hospital Only”.
8) Connect the recording system cable (model 653S) to the back of the Pod.
Maestro 4000™ Cardiac Ablation System
Controller Setup Guide
Page 34
11) Attach Dispersive Pad electrodes to the “Indifferent Electrode” receptacles on the front of the Pod.
14) To prepare a MetriQ
Pump for use, follow the in- structions in the MetriQ Pump Setup Guide.
12) Receive the 671 catheter cable from the sterile field.
15) Turn on the Controller by pressing the Main power switch on the front panel to the “I” position.
13) Connect the 671 catheter cable to the front of the Pod.
9) Connect the Pod cable to the “Isolated Patient Connec- tor” socket on the Controller front panel.
10) Receive the Dispersive Pad electrode cable(s) from the sterile field. Two are required for a high-power catheter, one for other catheters.
All ci ted trademarks ar e the propert y of their respect ive owners. CAUTION: Th e law restrict s these devices to sales by or on t he order o f a physician. Indications , contraindicat ions, warnings and ins tructio ns for use can be found in t he product labelin g supplied wit h each device. Infor mation for the use only in cou ntrie s with ap plicable h ealth au thori ty product regist rations.
EP-2 5260 1-AA J UN20 14 Printed in Germany by medicalvision.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2208EA
11) Attach Dispersive Pad electrodes to the “Indifferent Electrode” receptacles on the front of the Pod.
14) To prepare a MetriQ
Pump for use, follow the in­structions in the MetriQ Pump Setup Guide.
12) Receive the 671 catheter cable from the sterile field.
15) Turn on the Controller by pressing the Main power switch on the front panel to the “I” position.
13) Connect the 671 catheter cable to the front of the Pod.
9) Connect the Pod cable to the “Isolated Patient Connec­tor” socket on the Controller front panel.
10) Receive the Dispersive Pad electrode cable(s) from the sterile field. Two are required for a high-power catheter, one for other catheters.
Page 35
Maestro 4000Cardiac Ablation System
Troubleshooting Guide for APC Mode
PUMP DOES NOT TURN ON
Check that AC cord is plugged into wall.
Check that AC cord is connected properly to pump.
Check that cord is not frayed or damaged.
If pump has power the green power light will be lit.
TUBING IS LEAKING
Ensure catheter to tubing kit Luer connection is tight.
Replace tubing set for all other leaks.
SYSTEM DELIVERS RF IMMEDIATELY WITHOUT WAITING FOR PRE-RF FLOW
Check the pump display; it should read “Automatic”. If not, refer to the next section.
Check the setting for PRE-RF delay on the pump.
PUMP AND MAESTRO ARE CONNECTED AND POWERED ON, BUT PUMP DOESN’T SHOW “AUTOMATIC”
Check to make sure an OI catheter is connected to the Pod and the Maestro display is not showing a message.
Tighten the connections at each end of the communications cable between the Maestro 4000 and MetriQ Pump.
Check Maestro for “D12” error. If Error is displayed, press RF Power to clear.
If the previous actions don’t resolve the problem, use the Mains switches on the pump and Maestro to power
them off and back on.
PUMP BUBBLE DETECTOR TRIGGERS WITH NO VISIBLE BUBBLES.
Check the tubing for blemishes where it goes through bubble detectors.
Remove catheter from patient and purge catheter.
Check Saline bag. If empty replace.
Reinsert catheter in patient.
PULSING SENSATION AT THE CATHETER
Insure tubing set is not pulled taut.
Maestro 4000™ Cardiac Ablation System
Troubleshooting Guide for APC Mode
Page 36
OCCLUSION SENSOR TRIGGERS, BUT SALINE FLOWS FREELY FROM THE TIP.
Open the pump door completely.
Pull the tubing out of the bubble detectors on either side of the pump head. Gently stretch the cable and reinsert into
the bubble detectors. LEDs for both detectors should be green and tubing should be straight where it passes over the occlusion sensor.
PUMP REMAINING VOLUME LEVEL DOESN’T MATCH AMOUNT IN SALINE BAG
Open pump menu and check that the selected bag size matches the actual size.
If “Start New Case” was selected at startup, but bag was not replaced after previous session; or bag was replaced
and “Continue Previous Case” was selected, the volume remaining will be incorrect.
“New Saline Bag” was selected from the menu, but saline bag was not changed.
PRE-RF OR POST-RF TIME DIFFERENT THAN EXPECTED
Open pump menu and check the POST-RF and PRE-RF settings.
PUMP ALARM IS INAUDIBLE OR TOO LOUD
Open pump menu and increase or decrease the volume level. The level will be saved for future sessions.
CATHETER NOT RECOGNIZED. (OI CATHETER IS ATTACHED, BUT MAESTRO SAYS “FINDING CATHETER…”)
Check connections at both ends of catheter cable.
Check cable number printed on the catheter cable. If it does not read “671” replace the cable with a 671 cable.
Replace existing 671 cable with a new 671 cable.
Replace OI catheter.
Replace Pod.
RED LIGHT IN THE BUBBLE DETECTOR DOES NOT TURN FROM RED TO GREEN
Gently stretch the tubing and push into slot on bubble detector.
Close and latch door to push tubing into place. Open door again to check that LEDs have turned green.
Check the tubing for blemishes where it passes through bubble detectors. Replace tubing if it has blemishes.
PUMP IS UNRESPONSIVE OR ERROR MESSAGE ON PUMP CANNOT BE CLEARED
If the Maestro is displaying an error, clear the error on the Maestro, then clear the pump error.
This may occur if pump is powered on with the catheter in the patient. Remove the catheter from patient,
clear the error, enable standby flow and re-insert catheter.
If the above steps don’t clear the error use the power switch on the back of the pump to turn the pump off and back on. If a procedure is in process select “Continue Previous Case “ from the start-up menu.
Resume procedure.
All ci ted trad emarks ar e the property o f their respective owners. CAUT ION: The la w restricts t hese devi ces to sales by or on the order o f a physici an. Indica tions, contraindications, war nings and instructions f or use can be found in the p roduct lab eling supplied with each device . Information f or the use only in coun tries w ith appl icable heal th author ity pr oduct reg istra tions.
EP-2 5260 2-AA JU N2014 Printed in German y by medical vision.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2209EA
Page 37
Maestro 4000Cardiac Ablation System
Maestro Diagnostic Messages
Measured impedance below the low impedance threshold of 25 when using a high power catheter, or 50 for all other catheters.
Press RF Power button to clear the Diagnostic code.
Check all connections while monitoring the real-time Impedance on the alphanumeric display.
Replace components that appear damaged.
Resume RF delivery once the real-time
Impedance value is above the Low Impedance threshold.
Measured Impedance value is above the user defined set point between 150 to 300Ω.
Press RF Power button to clear the Diagnostic code. Ensure that the Impedance set point is above the appropriate Impedance value. Check the real­time Impedance display. If not below desired set point go through the following steps:
1. Ensure that the in-vivo catheter is connected to the appropriate extension cable – a list of catheter to cable pairings can be found in the catheter DFU.
2. Check all connections while monitoring real­time Impedance on the alphanumeric display. Begin with connections outside the sterile field (DIP connection to POD, extension Cable to POD). Finally verify good patient to DIP Electrodes surface contact.
3. If unsuccessful then replace components one at a time with new components. (catheter extension cable, DIP electrodes, POD if available, catheter).
Diagnostic Codes are displayed on the Alphanumeric Display. They indicate a condition that must be investigated before proceeding. If the Maestro is delivering RF energy when a diagnostic condition occurs, RF Delivery is terminated. To clear a Diagnostic Code, resolve the problem, then press the RF Power Button. Some diagnostic codes will require that the error be cleared prior to resolving the issue (eg. Low/High Impedance) in order to monitor the real time display. Below is a sampling of codes and corrective actions. All codes and complete operating instructions are in the Maestro Operator’s Manual.
Alphanumeric Display
D01-LOW IMPEDANCE
D02-HIGH IMPEDANCE
The Voltage, Current or Power has exceeded maximum values.
Restart Maestro 4000.
If error recurs and only 1 DIP electrode is in use,
apply a 2nd Electrode to patient.
Contact Boston Scientific.
Measured catheter tip temperature is at least 5°C greater than the set point for more than 4 seconds.
Press RF Power button to clear the Diagnostic code.
Verify normal body temperature reading from the in vivo catheter.
Verify that an appropriate Temperature set point, Power set point and Control Mode is selected for the desired catheter.
Restart the Maestro 4000 using the main switch.
Ensure that the POD is not covered, has adequate
ventilation and is not exposed to heat or cold sources.
Measured catheter tip temperature greater than 95°C for more than one second, or measured temperature exceeds set point temperature in Power Control mode.
Press RF Power button to clear the Diagnostic code.
Verify normal body temperature reading from the in-vivo catheter.
Verify that an appropriate Temperature set point, Power set point and Control Mode is selected for the desired catheter.
Restart the Maestro 4000 using the main switch.
Ensure that the POD is not covered, has adequate
ventilation and is not exposed to heat or cold sources.
D03-LIMIT EXCEEDED
D04-TEMP ABOVE SET POINT
D05-EXCESSIVE TEMPERATURE
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Maestro 4000™ Cardiac Ablation System
Maestro Diagnostic Messages
Page 38
Measured Catheter Tip temperature is either less than 15°C or greater than 95°C. (This code may also be dis-
played when a catheter is disconnected from the pod.)
Press RF Power button to clear the Diagnostic code.
Ensure that the catheter is in-vivo before connect­ing the extension cable.
Verify normal body temperature reading from the in-vivo catheter.
Restart the Maestro 4000 using main power switch.
Ensure that the POD is not covered, has adequate ventilation and is not exposed to sources of either heat or cold.
RF delivery was attempted when the measured temp­erature is greater than either 43°C or the temperature set point (whichever is lower), within 30 seconds of the previous RF delivery.
Press RF Power button to clear the Diagnostic code.
Ensure that the catheter is in-vivo before connect­ing the extension cable.
Verify normal body temperature reading from the in-vivo catheter.
Verify that an appropriate Temperature set point, Power set point and Control Mode are selected for the desired catheter.
If temperature changes with agitation, replace suspected components one at a time.
Restart the Maestro 4000 using the main power switch.
Ensure that the POD is not covered, has adequate ventilation and is not exposed to sources of either heat or cold.
The Maestro 4000 detects an issue with the pod connection.
Press RF Power button to clear the Diagnostic code.
• Disconnect the catheter extension cable from the POD.
Power down the Maestro 4000 using the main
power switch.
Verify that the POD Cable is connected correctly to the front of the Maestro 4000 Patient Isolated Connector.
Ensure that there are no kinks or tight loops in the cable. Switch on the Maestro 4000 using main power switch and allow Self Test to complete. Once Self Test is complete and “Finding (cont...)
D06-TEMP OUT OF RANGE [15C-95C]
D07-TEMPERATURE TOO HIGH
D08-CHECK POD
Cause:
Action:
Cause:
Action:
(Cont...) Catheter” is displayed on the screen, connect the catheter extension cable to the POD. The Maestro 4000 should then return to a Ready/ Standby state, displaying both real-time tempera­ture and impedance. If this does not resolve the issue, replace the POD.
Generator doesn’t recognize catheter ID.
Press RF Power button to clear the Diagnostic code.
Replace catheter cable.
If error recurs replace catheter.
If error recurs replace pod.
There is a communications problem between the Remote and Maestro 4000 or the Remote was discon­nected or connected during RF.
Check cable and connections between the Maestro 4000 and Remote, tightening the thumb screws on the connectors. Replace cable or Remote if dam­age is suspected.
A diagnostic condition occurred on the MetriQ or there is a communication error between the Maestro 4000 and the MetriQ.
Resolve problem on pump and clear the diagnos­tic condition there, then press RF Power to clear the error on the Maestro 4000.
Check the communications cable connections between the Maestro 4000 and MetriQ. Tighten thumb screws on the connectors.
Replace the communications cable if damage is suspected.
D08-CHECK POD (Cont.)
D10-INVALID CATHETER ID
D11-CHECK REMOTE
D12-CHECK PUMP
Cause: Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
All ci ted trademarks are t he property of the ir respec tive ow ners. C AUTION: The law rest ricts t hese devices t o sales by or on the order o f a physician. Indica tions, co ntrain dications , warnings and instructions for use can be found in the product l abeling supplied with e ach device. Information for the use onl y in countri es with applicable h ealth au thority produ ct regis trations .
EP-2 5260 3-AA J UN20 14 Print ed in Germany by medical vision.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2210EA
Page 39
Maestro 4000Cardiac Ablation System
Maestro Operational Messages
This message is displayed in temperature control mode when the delivered power reaches the power set point value. It indicates that the temperature set point cannot be reached at the current power level.
Reduce temperature set point or increase power set point, as appropriate.
Maestro 4000 limits the amount of current through a single dispersive pad to prevent burns to the patient. This message is displayed periodically while power is limited. The limit may be reached if a high power catheter is used with a single dispersive pad.
If using a high-powered catheter with a single Dispersive Indifferent Patch (DIP), add a 2nd DIP if additional power is required.
Monitor the real-time impedance display. If imped-
ance is below the expected range, replace compo­nents one at a time with new components. (catheter extension cable, DIP electrodes, POD if available, catheter).
This message indicates a higher than expected imped­ance. Higher than typical impedance measurements may indicate a faulty DIP application or failure of an electrical lead. Check real-time Impedance value. If it’s above expected impedance go through the following steps:
1. Ensure that the in-vivo catheter is connected to the appropriate extension cable – a list of catheter-to­cable pairings can be found in the catheter’s DFU.
2. Check all connections while monitoring real-time impedance on the alphanumeric display. Begin with connections outside the sterile field (DIP connection to POD, extension Cable to POD). Verify good patient to DIP Electrodes surface contact.
3. If unsuccessful, then replace components one at a time with new components. (catheter extension cable, DIP electrodes, POD if available, catheter)
This message indicates a normal condition. It is displayed during an open-irrigated ablation sequence while the pump delivers fluid at the ablation flow rate during pre-RF and post-RF delay.
Wait for MetriQ Pump to complete pre-RF delay or post-RF delay (or adjust the delay duration on MetriQ Pump as appropriate).
This message is displayed when RF power is requested but the MetriQ’s menu is open (when Maestro 4000 is operating with MetriQ Pump in Automatic mode). RF delivery is prevented until the pump menu is closed.
Close the pump menu before requesting RF Power delivery.
This message indicates a normal condition. It is dis­played if RF power is requested and the time setting has not been changed from the default 0 seconds.
Adjust time setting to an appropriate value before requesting RF delivery.
This message indicates a normal condition. It is dis­played when RF power is requested but the power setting has not been changed from the default 0 Watts.
Adjust power setting to an appropriate value before requesting RF delivery.
Operational Codes are displayed on the Alphanumeric Display. Operational Codes explain Maestro 4000 behavior or indicate a non­hazardous condition that may require action. Below is a sampling of codes and suggested actions. A complete description of all codes and complete operating instructions are in the Maestro 4000 Operator’s Manual.
Alphanumeric Display
M02-POWER LIMITED, POWER SETTING M04-POWER LIMITED, HIGH IMPEDANCE (Cont.)
M05-WAIT FOR PUMP
M03-POWER LIMITED, LOW IMPEDANCE
M04-POWER LIMITED, HIGH IMPEDANCE
M06-CLOSE PUMP MENU
M07-SET TIME
M08-SET POWER
Cause:
Action:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Maestro 4000™ Cardiac Ablation System
Maestro Operational Messages
Page 40
This message indicates a normal condition. It is displayed when RF power is requested for a non-OI catheter but the temperature setting has not been changed from the default.
Adjust temperature setting to an appropriate value before requesting RF delivery.
Communication has been interrupted between the Maestro and Pump while the Maestro is in STANDBY mode. When the Maestro 4000 and MetriQ are con­nected and have an OI catheter attached, they oper­ate in Automatic mode. In this state the pump will display “Automatic” at the top of the display screen. If they become disconnected, the system will switch to manual mode and the pump will display “Manual”. In manual mode the Maestro 4000 and MetriQ Pump operate independently. The Maestro 4000 will not wait for the pump to start ablation flow before deliver­ing RF Power to the catheter. If the message is displayed while the communications cable is connected, do the following:
1. Check the cable connections between the Maestro 4000 and MetriQ Pump. Tighten the thumb screws on the connectors.
2. Replace the communications cable.
The default Power/Temperature mode for non-OI cath­eters is Temperature mode. If Power mode is selected instead, the Maestro reduces power by 50% and dis­plays this message when the temperature exceeds the temperature set point.
Verify that power-control mode is the desired mode of operation.
Decrease the power setting and/or increase the temperature setting as appropriate.
M09-SET TEMPERATURE M11-RF REDUCED 50%, MAX TEMP REACHED
M10-RECONNECT PUMP
Cause:
Action:
Cause:
Action:
Cause:
Action:
This message indicates a normal condition. It is displayed when RF power is requested for a non-OI catheter but the temperature setting has not been changed from the default.
Adjust temperature setting to an appropriate value before requesting RF delivery.
Communication has been interrupted between the Maestro and Pump while the Maestro is in STANDBY mode. When the Maestro 4000 and MetriQ are con- nected and have an OI catheter attached, they oper- ate in Automatic mode. In this state the pump will display “Automatic” at the top of the display screen. If they become disconnected, the system will switch to manual mode and the pump will display “Manual”. In manual mode the Maestro 4000 and MetriQ Pump operate independently. The Maestro 4000 will not wait for the pump to start ablation flow before deliver- ing RF Power to the catheter. If the message is displayed while the communications cable is connected, do the following:
1. Check the cable connections between the Maestro 4000 and MetriQ Pump. Tighten the thumb screws on the connectors.
2. Replace the communications cable.
The default Power/Temperature mode for non-OI cath- eters is Temperature mode. If Power mode is selected instead, the Maestro reduces power by 50% and dis- plays this message when the temperature exceeds the temperature set point.
Verify that power-control mode is the desired mode of operation.
Decrease the power setting and/or increase the temperature setting as appropriate.
M09-SET TEMPERATURE M11-RF REDUCED 50%, MAX TEMP REACHED
M10-RECONNECT PUMP
Cause:
Action:
Cause:
Action:
Cause:
Action:
All ci ted trademarks are the propert y of their res pective owner s. CAU TION: T he law res tricts t hese dev ices to sales by or on th e order o f a physician. Indications, contraindica tions, warnings and instructions for use can be foun d in the product labeling supplied wit h each device. Information for the use only in countries wit h applicab le healt h authority product r egist ratio ns.
EP-2 5260 4-AA JUN2014 Prin ted in Ger many by medicalvi sion.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2211EA
Page 41
Note: This Guide is not intended to replace the MetriQ Operator’s Manual. Thoroughly review the manual before installing or operating the MetriQ Pump. Complete installation diagrams are shown in the manual.
Sterile
Field
1) Connect the power cord to the back of the MetriQ Pump.
4) Use the power switch on the back of the MetriQ Pump to power it on.
7) Open the MetriQ Pump door completely. Gently stretch the tubing and insert it ac­cording to the diagram on the inside of the door.
10) Connect the tubing to the heparinized saline (0.9%) irrigation source.
3) Connect the other end of the cable Gen­erator to Pump or Remote to the Peristaltic Pump port on the back of the Maestro 4000.
6) Receive the tubing from inside the sterile field.
2) Connect the MetriQ Pump to Maestro 4000 cable, Generator to Pump or Remote.
5) Note: Select one and press Enter. Starting a New Case resets dispensed and infused fluid volumes to 0ml. Continuing Previous Case retains previous volumes.
8) Close the door and wait for the MetriQ Pump to finish calibration.
Start New Case YES
Continue Previous Case: NO
Automatic Mode
2
17
30
2000
mL remaining
PLEASE WAIT
IN PROGRESS
CALIBRATION
11) Purge the tubing and catheter to remove air bubbles. Bubbles may be purged manually or with the
PURGE
button. Press and hold the Purge button to deliver 60 ml/min of saline flow. Release to stop flow.
9) Use the menu buttons to modify settings or press a memory button to select saved settings.
To save settings, press down the memory button until the LED light flashes green and generator makes a tone.
Maestro 4000Cardiac Ablation System
MetriQ Pump Setup Guide
Maestro 4000™ Cardiac Ablation System
MetriQ™ Pump Setup Guide
Page 42
Select the size of the saline bag (500mL, 1000mL, 1500mL or 2000mL).
Press to open and close menu, and to abort changes.
Press to select item and accept changes.
Move through menu and adjust settings.
Select the point at which the Low Fluid warning will be triggered (OFF, 0, 100, 200, 300, 400, 500 mL).
Select the volume measurement to be displayed on the front panel, Infused, Remaining or Dispensed.*
Select YES to reset the Volume Remaining to the current setting for Saline Bag Size. Selecting NO has no effect.
Change the Pre-RF and Post-RF ablation flow delays (Pre-RF=1-15 sec, Post-RF=0-15 sec).
Select YES to reset the dispensed and infused irrigation fluid volumes to 0. Selecting NO has no effect.
If catheter tip temperature fails to drop by this amount during Pre-RF delay, the generator will not deliver RF (may be set from 0° to 5°C).**
Set the volume for audible alarms and tones. This setting is retained when MetriQ Pump is shut off. (1-5 loudest)
When Maestro 4000 power exceeds this point, MetriQ Pump will switch from LOW ABLATION FLOW to HIGH
ABLATION FLOW ( 1W to 50 Watt).
SILENCE ALARM: Stops Alarm from beeping temporarily.
Alarm LED continues flashing.
CLEAR MESSAGE: Press to clear alarm
when problem has been resolved.
Menu Settings
Alarms
Saline Bag Size: 2000 mL
Fluid Vol. Display: Remaining
New Procedure? YES
Loudness: 3
Low Fluid Warning: 100 mL
New Saline Bag? YES
Min. Temp.Drop: 5 deg. C
To Trigger Hi Flow: 30 Watts
Pre-RF Delay: 2 sec
Post-RF Delay: 4 sec
Select the size of the saline bag (500mL, 1000mL, 1500mL or 2000mL).
Press to open and close menu, and to abort changes.
Press to select item and accept changes.
Move through menu and adjust settings.
Select the point at which the Low Fluid warning will be triggered (OFF, 0, 100, 200, 300, 400, 500 mL).
Select the volume measurement to be displayed on the front panel, Infused, Remaining or Dispensed.*
Select YES to reset the Volume Remaining to the current setting for Saline Bag Size. Selecting NO has no effect.
Change the Pre-RF and Post-RF ablation flow delays (Pre-RF=1-15 sec, Post-RF=0-15 sec).
Select YES to reset the dispensed and infused irrigation fluid volumes to 0. Selecting NO has no effect.
If catheter tip temperature fails to drop by this amount during Pre-RF delay, the generator will not deliver RF (may be set from 0° to 5°C).**
Set the volume for audible alarms and tones. This setting is retained when MetriQ Pump is shut off. (1-5 loudest)
When Maestro 4000 power exceeds this point, MetriQ Pump will switch from LOW ABLATION FLOW to HIGH
ABLATION FLOW ( 1W to 50 Watt).
SILENCE ALARM: Stops Alarm from beeping temporarily.
Alarm LED continues flashing.
CLEAR MESSAGE: Press to clear alarm
when problem has been resolved.
Menu Settings
Alarms
Saline Bag Size: 2000 mL
Fluid Vol. Display: Remaining
New Procedure? YES
Loudness: 3
Low Fluid Warning: 100 mL
New Saline Bag? YES
Min. Temp.Drop: 5 deg. C
To Trigger Hi Flow: 30 Watts
Pre-RF Delay: 2 sec
Post-RF Delay: 4 sec
* Infused is the tot al amount of heparinized saline (0 .9%) pumped wh ile the ca theter is in the pa tient . Dispensed includes the
infused volume plus heparinized saline (0.9%) pumped when the catheter is outside the patient.
** T his is a safety feature to ensure the MetriQ Pump is properly cooling t he cathe ter tip.
All ci ted trademarks are the propert y of their respect ive owners. CAU TION : The law res trict s these devices to sales by or on the order o f a physician. Indications , contr aindications, w arnings and instructions for use can be found in the product labeli ng supplied wit h each device. Infor mation for the us e only in countries with applicable health authority pr oduct registrations .
EP-25 2702-A A JUN20 14 Prin ted in Germany by medicalvis ion.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2213EA
Page 43
Maestro 4000Cardiac Ablation System
MetriQ Pump Messages
This message indicates that a bubble has been detected in the tubing.
Remove the catheter from the patient. Check saline bag leve and replace if necessary. Check drip chamber level and adjust if necessary. Press CLEAR
MESSAGE. Press and hold the PURGE button until air
bubbles have been purged from the system. Press
STANDBY FLOW to resume pump operation. Return
the catheter to the patient and resume procedure.
Indicates pressure above expected levels during both purge and non-purge flow. This can indicate a blockage in the tubing or catheter.
Inspect tubing for kinks or defects. Replace if necessary. Remove the catheter from the patient. If occlusion appears to be in the catheter, replace the catheter. Press CLEAR MESSAGE. Press and hold
PURGE button until air has been purged from the new
catheter and/or tubing, then press STANDBY FLOW to resume pump operation. Return the catheter to the patient (if appropriate) and resume procedure.
The temperature drop detected at the catheter tip during Pre-RF delay is less than the Min. Temp. Drop setting.
Press CLEAR MESSAGE. Adjust the Min. Temp. Drop and Pre-RF delay menu items, or adjust flow rate, if appropriate. Check tubing set and catheter for poor connections or leaks. Correct connections as appropriate. If leaking continues, replace catheter or tubing set.
Check drip chamber for indication of flow. If no flow and the pump head is turning, the catheter may be occluded and the pump occlusion sensor inoperative.
Replace the catheter and pump. Press STANDBY
FLOW to resume pump operation. Return the
catheter to the patient (if appropriate) and resume procedure.
The pump door has come unlatched during fluid flow, or force is applied to open the door during flow.
Do not try to open the door during flow. If open, close and latch the door. Press the CLEAR
MESSAGE button. Press the STANDBY FLOW but-
ton to resume pump operation.
Displayed if the RF generator detects the catheter is in the patient and the pump is not running in STANDBY or ablation flow.
Remove catheter from patient and press the
PURGE button (if appropriate). Press the STANDBY FLOW button. Press the CLEAR MESSAGE button. Return the catheter to the
patient and resume the procedure.
Indicates the pump has lost communication with the RF generator or catheter during ablation flow.
Check the Pump to RF Generator Cable. Reconnect the catheter cable to the Pod. Press the CLEAR MESSAGE button.
This diagnostic error indicates that the measured pump speed is 85% or 120% of the calculated nominal speed based on the flow rate setting during Standby or Ablation flow.
• Open door completely and inspect the tubing set. Reinstall the tubing set. Install a new tubing set if the set appears damaged or defective. Press CLEAR
MESSAGE.
MetriQ displays messages on the Alphanumeric Display as shown to the left. Below is a sampling of codes and corrective actions. More complete information can be found in the MetriQ Operator’s Manual.
Diagnostic Messages
Diagnostic messages stop the flow of fluid and indicate a condition that must be investigated before proceeding. To clear the message, first resolve the problem, then press CLEAR MESSAGE. A diagnostic message on the MetriQ will cause “D12-CHECK PUMP” on the Maestro 4000. The errors must be cleared on both devices before an ablation can be performed. Clear the pump error first.
P01 - BUBBLE DETECTED
P03 – NO TEMP DROP (Cont.)
P04 - COVER OPEN
P02 - OCCLUSION DETECTED
P03 – NO TEMP DROP
P05 - CHECK STANDBY FLOW
P06 - COMM ERROR
P07 - PUMP SPEED ERROR
Cause:
Action:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Alphanumeric Display
Maestro 4000™ Cardiac Ablation System
MetriQ™ Pump Messages
Page 44
Pump is under control of the Maestro 4000™. This mode is entered when the Maestro 4000 and pump are powered on and communicating; and an open-irrigated (OI) catheter is connected.
No action required.
Maestro 4000 has a diagnostic error, or pump lost com­munication with Maestro during RF delivery.
Check the Maestro 4000 for a diagnostic error and resolve the error according to the Maestro 4000 Operator manual. If there is no error and Maestro 4000 is delivering RF energy when this message is displayed, check connection of the communica­tion cable between the MetriQ and Maestro 4000. Tighten thumbscrews on connectors.
After the power on self-test is complete, the Pump will prompt the user to select “Start New Case” or “Continue Previous Case”
Select “Continue Previous Case” to keep the previ­ous dispensed and infused volume levels. Note: If
the saline bag size is smaller than 2000 mL you must also reset the bag size through the menu. Otherwise the remaining volume will be incorrect.
The pump door is open and a Standby, Low, High or Purge flow button was pressed. (This message has the
same text as P04, but is only displayed when there is no flow).
Close the door, then press the desired flow button.
If door is already closed it may not be completely latched. Twist the door knob to the right.
Pump lost communication with the Maestro 4000. This could occur if the communications cable is not securely attached to both devices. It will also occur if the Maestro 4000 has a Safe state error. This message is only displayed if the pump is in Automatic Mode when the error occurs.
Check the Maestro 4000 for errors. Refer to the Maestro 4000 manual to resolve generator errors.
If message is displayed while the communications cable is connected, do the following:
1. Check the cable connections between the Maestro 4000 and MetriQ. Tighten thumb screws on the connectors.
2. Replace the communications cable.
Displayed if the Pump is not under control of a Maestro
4000. The pump will also be in manual mode if the pump and Maestro 4000 are connected, but an OI cath­eter is not attached to the Maestro 4000.
If you intend to operate the pump in automatic mode, but the pump shows “Manual Mode”, first check to make sure the OI catheter and pod are securely connected. Next check the cable as described under “GENERATOR DISCONNECTED
The fluid remaining in the saline bag is below the menu setting for “Low Fluid Warning”.
Check bag to verify saline volume. User error may cause a discrepancy between actual and calcu­lated. If low, press the stop button to stop flow. Change saline bag. Then go to menu and set the parameter “New Saline Bag” to Yes.
After the power on self-test, the Pump will prompt the user to select “Start New Case” or “Continue Previous Case”
Select “Start New Case” to reset the dispensed and infused volume levels to zero.
An unrecoverable error has occurred on the pump. Pump enters SAFE mode and ignores all input.
Record the error number, power off the pump and contact BSC field service for further assistance.
Tubing is not loaded correctly.
Open the pump door. Check that the tubing “stops” are in the recesses on either side of the pump head.
Automatic Mode Manual Mode
SALINE VOL. LOW < XXX ML
Start New Case
SYSTEM FAULT
TUBING NOT LOADED
CHECK GENERATOR
Continue Previous Case
COVER OPEN
GENERATOR DISCONNECTED
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause: Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Cause:
Action:
Operational Messages
Operational messages explain MetriQ™ Pump behavior or indicate a non-hazardous condition. Not all operational messages are listed here. For a description of all messages see the Operator’s Manual.
All ci ted trademar ks are the prop erty of t heir respective o wners. C AUTION : The law res tricts t hese devices t o sales by or on the order o f a physicia n. Indications, co ntrain dicatio ns, warni ngs and instr uctions fo r use can be fou nd in the pro duct labeling supplied with e ach device. I nformat ion for the u se only in co untries with ap plicable he alth aut hority p roduct regis tration s.
EP-2 52701-AA JUN2014 P rinted in Ger many by medical vision.
www.bostonscientific.com
© 2014 Boston Scientific Corporation or its affiliates. All rights reserved. DINEP2212EA
44
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