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EndoPAT 2000
Itamar Medical EndoPAT 2000 Manuals
Manuals and User Guides for Itamar Medical EndoPAT 2000. We have
2
Itamar Medical EndoPAT 2000 manuals available for free PDF download: User Manual, Operation Manual
Itamar Medical EndoPAT 2000 User Manual (111 pages)
Brand:
Itamar Medical
| Category:
Medical Equipment
| Size: 3.87 MB
Table of Contents
User Manual
1
Table of Contents
5
1 General Information
10
Intended Use of the Endo PAT
10
TM 2000 Device
10
Performance and Clinical Study Information
10
Equipment Classification
12
Manufacturers Notice
12
Restrictions for Use
12
Quality Assurance System: ISO 9001 & ISO 13485
13
Conventions Used in this Manual
15
Safety Precautions
16
2 System Overview
18
How to Use this Manual
18
List of Figures Figure 1 Typical Set-Up
19
System Description
20
Connecting the Endo PAT
21
3 Installing the System
19
Basic System Configuration
19
TM 2000 Device to the Computer
21
Figure 3 - Connection of Pneumo-Electric Tubing and USB Adaptor
21
Endo PAT TM 2000 Software Installation
22
Figure 4 - Installshield Wizard
23
Figure 5 - License Agreement
23
Figure 6 - Installation Option
24
Figure 7 - Installation Folder Selection
24
Figure 8 - Ready to Install the Program Screen
25
Figure 9 - Completion of Installation
25
Installing the RS-232 to USB Adaptor
26
Registration
27
Figure 10 - Registration Reminder and Number of Left Trial Recording
28
Figure 11 - Registration
28
Figure 12 - Registration Dialog
29
Figure 13 - Registration Request File Instructions
30
Figure 14 Viewer Mode Registration
31
Uninstalling Endo PAT
32
TM 2000 Software
32
Figure 15 - Registration Request File Instructions (Viewer Mode)
32
Shutting down the System
33
4 Software Description
34
Main Screen
34
Figure 16 - Main Screen
34
Figure 17 - Fill Site Name Dialog Box
35
Main Screen Menu Commands
36
Main Screen Tool Bar
36
Figure 18 - Viewer Mode Registration Reminder
36
Table 1 - Main Screen Pull down Menu Commands
36
Table 2 - Tool Bar Buttons and Functions
37
Configuring the System
38
Figure 19 - Gain and Time-Base Scroll Boxes
38
Figure 20 - the Setup Command
39
Figure 21 - the Setup Dialog Box (Full Application and Viewer Mode)
39
Figure 22 - Report Setup Dialog Box
41
Figure 23 - the Example for Report Header
41
Figure 24 - the Patographer Information Dialog Box
42
Using the Timer (Countdown Clock) (Full Application Only)
43
Setting the Default Printer
43
5 Preparing for a Study
44
Preparing the System for a Study
44
Connecting the PAT™ Probe
44
Figure 25 - COM Port Search
44
Creating a Patient File
45
Figure 26 - Inserting into Slit
45
Figure 27 - Clicking in
45
Figure 28 - Press to Release
45
Figure 29 - Probe Disconnected
45
Figure 30 - Patient Information Dialog Box (Metric Version)
46
Figure 31 - "File ID Exists" Warning Message
47
Figure 32 - Patient Information - Risk Factors
49
Table 3 - Risk Factors Mandatory Fields
49
6 Conducting an Endo PAT 2000 Study
50
Pre-Study
50
Patient and System Setup
52
Figure 33 - Used Probes Warning
52
Figure 34 - Applying the PAT™ Probes
53
Performing the Study
54
Figure 35 - Hands Set-Up
54
Figure 36 - Standby Mode
55
Figure 37 - Recording
56
Figure 38 - Occlusion Quality Assessment
58
7 Review and Analysis
60
Study Data Retrieval
60
Automatic Analysis
60
Figure 39 - Open File Dialog Box
60
Figure 40 - Automatic Analysis
61
Figure 41 - Occlusion Popup Menu
62
Study Report
63
Endo PAT TM 2000 Study Results
63
Figure 42 - Non Selective Population Histograms of RHI
64
Figure 43 - Non Selective Population Histograms of Lnrhi
65
Figure 44 - Lnrhi Distribution in Non-Selective Population
65
Cardiovascular Risk
66
Figure 45- Historical Endoscore Results - Table and Chart
66
Additional / Research Features
67
Figure 46 - AI Calculation
68
Figure 47 - AI Result from the Report (Female Example)
69
Tabular Report
70
Figure 48- Time Domain HRV in the Report
70
Figure 49- Frequency Domain HRV in the Report
70
Table 4 - Table Information
72
Batch Analysis
73
Manual Analysis (Manual Research Mode Only)
73
Figure 50 - Marking Segments and Artifacts
74
7.10 Study Printing
76
7.11 Uploading Data to the Server
76
8 Maintenance
77
Device Maintenance
77
Probe Data
77
9 Troubleshooting
78
Figure 51 - Probes Information
78
Table 5 - Troubleshooting
79
Table 6 - Troubleshooting License
81
Table 7 - Error Messages
82
10 Technical Information
83
10.1 System Minimum Requirements
83
10.2 Operating System
83
10.3 Technical Information about Labeling
83
10.4 Labeling
85
TM 2000 System
87
Table 8 - Specifications
87
Appendix A: License Agreement and Limited Warranty
88
Appendix B: Regulatory Authorized Representative
94
Appendix C: Installing the USB Adaptor for Windows XP
95
Figure 52 - MOXA USB Installation - XP1
95
Figure 2 - Endo PAT TM 2000 Device
96
Figure 53 - MOXA USB Installation - XP2
96
Figure 54 - MOXA USB Installation - XP3
96
Figure 55 - MOXA Adapter
97
Figure 56 - MOXA Adapter Configuration - XP2
97
Figure 57 - MOXA Adapter Configuration - XP3
98
Figure 58 - MOXA Adapter Configuration - XP4
98
Figure 59 - MOXA Adapter Configuration - XP5
99
Figure 60 - MOXA Adapter Configuration - XP6
99
Figure 61- Connect MOXA Adaptor
100
Figure 62 - Connect COM to COM
100
Appendix D: Installing the USB Adapter for Windows 7 or 8
101
Figure 63 - Win Security
101
Figure 64 - Win7 Security
102
Figure 65 - MOXA Uport Driver Installation
102
Figure 66 - MOXA Driver Installation Folder
103
Figure 67 - MOXA Driver Folder Confirmation
103
Figure 68 - MOXA Driver Installation Finish
104
Figure 69 - the MOXA Adapter
104
Figure 70- Connect MOXA Adaptor
106
Figure 71 - Connect COM to COM
106
Appendix E: Manufacturing Declarations According to Iec 60601-1-2
107
Recommended Separation Distances
110
Appendix F: Spare Parts List
111
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Itamar Medical EndoPAT 2000 Operation Manual (87 pages)
Brand:
Itamar Medical
| Category:
Diagnostic Equipment
| Size: 3.13 MB
Table of Contents
Table of Contents
4
1 General Information
7
Intended Use of the Endopat TM X Device
7
Performance and Clinical Study Information
7
Equipment Classification
9
Manufacturers Notice
9
Restrictions for Use
9
Quality Assurance System: en ISO 13485
10
Conventions Used in this Manual
13
Safety Precautions
13
2 System Overview
16
How to Use this Manual
16
3 Installing the System
17
Basic System Configuration
17
System Description
18
Connecting the Endopat TM X Device to the Computer
19
Endopat
20
Uninstalling Endopat TM X Software
21
Shutting down the System
22
4 Endopatx Application Description
23
Endopatx User Roles
23
Login Screen
23
Search for Patient Screen - Operator
24
Conducting Endopatx Study - Operator
32
Reviewing the Endopatx Study - Reviewer
42
5 Preparing for a Study
49
Preparing the System for a Study
49
Connecting the PAT™ Probe
49
Creating/Updating Patient's Record
50
6 Conducting an Endopat
53
Pre-Study
53
Patient and System Setup
55
Performing the Study
56
7 Review and Analysis
60
Study Data Retrieval
60
Automatic Analysis
60
Study Report
61
Endopat
61
Cardiovascular Risk
63
Additional / Research Features
65
Study Printing
68
8 Maintenance
69
Device Maintenance
69
9 Troubleshooting
70
System Error Messages
72
10 Technical Information
73
System Minimum Requirements
73
Operating System
73
Technical Information about Labeling
73
Labeling
75
Specifications of Endopat TM X System
77
Appendix A: License Agreement and Limited Warranty
78
Appendix B: Regulatory Authorized Representative
79
Appendix C: Manufacturing Declarations According to Iec 60601-1-2
80
Appendix D: Spare Parts List
87
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