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EPT-1000 XP
Boston Scientific EPT-1000 XP User Manual
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EPT-1000 XP
TM
Cardiac Ablation System
Aflutter IDE 110V
Operator’s Manual
CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
EP Tec
hnologies, Inc.
2710 Orchar
d Park
way
San Jose, CA 95134
Phone: 408.895.3500
P/N 13754-901 EAW
Ver AA 6/01
2
Table of Contents
Preface
3
General Information
3
Table of Contents
4
1 System Description
9
System Features
10
Safety Features
10
Control Modes
11
Table 1-1: Power Delivery Protocol
11
Figure 1-1: System Installation Diagram
12
Figure 1-2: Cable Configuration for Quick Connect XP APM
13
2 Indications/Contraindications
15
Indications for Use
15
Contraindications
15
3 Warnings, Precautions, and Adverse Reactions
17
Warnings
17
Precautions
18
Adverse Reactions
20
4 Unpacking the Controller
21
Unpacking
21
Repackaging the Controller
21
5 Controls and Displays
23
Front Panel
23
Figure 5-1: Controller Front Panel
23
CONTROL Panel
24
Figure 5-2: CONTROL Panel Indicator Leds and Button
24
Table 5-1: Maximum Amount of Power Output for Catheters
25
Figure 5-3: POWER Display and Buttons
26
POWER Panel
26
Figure 5-4: TEMPERATURE Display and Buttons
27
TEMPERATURE Panel
27
Table 5-2: Summary of TEMPERATURE Display Readings
28
IMPEDANCE Panel
29
Figure 5-5: IMPEDANCE Display
30
Figure 5-6: TIME Display and Buttons
31
TIME Panel
31
COUNTER Panel
32
Figure 5-7: COUNTER Display and Clear Button
32
RF POWER CONTROL Panel
32
CALIBRATION Panel
33
Figure 5-8: RF POWER CONTROL Panel and Button/Light
33
Isolated Patient Connector
34
MAINS (Power "ON") Display
34
Table 5-3: Individual Analog Outputs
34
Rear Panel
35
Figure 5-10: Controller Rear Panel
35
Accessories
38
Footswitch
38
High Power Automatic Personality Module (XP APM)
38
Figure 5-11: High Power Automatic Personality Module with Quick Connect
39
6 Operational Sequence
41
Initial Installation
41
Figure 6-1: Connecting the XP APM to the Controller Front Panel
41
Figure 6-2: Connecting the XP APM to the Recording Equipment
42
Figure 6-3: Connecting the Catheter to the XP APM Front Panel
43
Figure 6-4: Connecting the Disposable Indifferent Patch Electrodes
44
Turning the Controller "ON
45
Figure 6-5: Connecting the Footswitch to the Controller Rear Panel
45
READY Mode
46
Figure 6-6: Turning the Controller to the on Position
46
Figure 6-7: Ready Mode, Initialization - Catheter(T°) Connected
47
Figure 6-8: Ready Mode, Initialization - Catheter(Non-T) Connected
47
Calibrating the Controller Analog Outputs for the Recorder
48
Selecting the Control Mode
48
Figure 6-9: Calibrating the Controller Analog Outputs
48
Selecting the Power Output
49
Selecting the Desired Catheter Tip Temperature
50
Control Mode
50
Mode
51
Setting the Time Control
51
Clearing the Counter
52
Adjusting the Audio Control
53
Figure 6-10: Adjusting Audio Control
53
Turning the RF Power Delivery "ON
54
Table 6-1: TEMPERATURE Display Readings
55
Table 6-2: Impedance Display Readings
56
Directions for Use
58
Turning the RF Power Delivery "OFF
59
Possible Causes of RF Power Delivery Interruption
59
7 Service and Maintenance
61
Cleaning/Disinfecting
61
Replacing the Fuses
61
8 Product Specifications
63
General Specifications
63
Table 8-1: System Specifications
63
Environmental Specifications
67
Table 8-2: Environmental Specifications
67
Power Delivery
68
Figure 8-1: Output Power Vs. Tissue Impedance
68
Error Codes
69
Table 8-3: Error Codes
69
Figure 8-2: Labeling Symbols
70
9 Limited Warranty and Disclaimer
71
Limited Warranties
71
Disclaimer and Exclusion of Other Warranties
71
Limitation of Liability for Damages
71
10 Index
73
4
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Boston Scientific EPT-1000 XP Specifications
General
Brand
Boston Scientific
Model
EPT-1000 XP
Category
Medical Equipment
Language
English
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