Itamar Medical OM1695230 Manuals

Manuals and User Guides for Itamar Medical OM1695230. We have 1 Itamar Medical OM1695230 manual available for free PDF download: Operation Manual

Itamar Medical OM1695230 Operation Manual (89 pages)

Brand: Itamar Medical | Category: Medical Equipment | Size: 4 MB

Table of Contents
5
General Information
9
Intended Use of the Endopat TM X Device
9
Performance and Clinical Study Information
9
Equipment Classification
11
Manufacturers Notice
11
Restrictions for Use
11
Quality Assurance System: en ISO 13485
12
Conventions Used in this Manual
14
Safety Precautions
14
System Overview
17
How to Use this Manual
17
Installing the System
18
Basic System Configuration
18
Figure 1 - Typical Setup of Endopat™X Study
18
System Description
19
Figure 2 - Endopat™X System
19
Connecting the Endopat TM X Device to the Computer
20
Figure 3 - Knob for USB Cable
20
Endopat TM X Software Installation
21
Uninstalling Endopat TM X Software
23
Shutting down the System
23
Endopat TM X Application Description
24
Endopat TM X User Roles
24
Creating User Roles
24
Figure 4 - Login Screen
24
Figure 5 - Local Admin Pull down Menu
25
Figure 6 - List of Users
25
Figure 7- Create User
25
Operator - Patient Management Screens
26
Figure 8 - Search/Create Patient
26
Figure 9 - Selecting Name/ID from List
27
Figure 10 - Search Button List
27
Figure 11- Add New Patient
27
Figure 12 - New Patient
28
Figure 13 - Patient Record and New Study
28
Figure 14 - Edit/Update Patient Info
29
Figure 15 - Insert Risk Factors-Framingham
30
Figure 16 - Insert Risk Factor - Reynolds
30
Figure 17 - Insert Risk Factor - European
30
Figure 18 - List of Previous Studies
31
Figure 19 - Previous Study Options
32
Figure 20 - View Signal Screen
32
Figure 21 - Exported Endopat TM X File
33
Figure 22 - Report File
33
Figure 23 - CSV File
33
Conducting Endopat TM X Study - Operator
34
Figure 24 - Initiating New Test
34
Figure 25 - Open Probs
34
Figure 26 - New Study Screen
35
Figure 27 - Baseline
37
Figure 28 - End of Study Comment
39
Figure 29 - Study Screen
39
Figure 30 - Error Indicator
41
Figure 31 - Detail of Error
41
Reviewing the Endopat TM X Study - Doctor (Reviewer)
43
Figure 32 - Search Patient
43
Figure 33 - Search Button List of Patients
43
Figure 34 - Patient Record - Doctor View
44
Figure 35 - Patient Record - Doctor View: Single Study Review Options
44
Figure 36 - Patient Record - Patient View
45
Figure 37 - Endopat TM X Study Review Main Screen
46
Figure 38 - Manual Research Mode Analysis and Signal View Screen
48
Figure 39 - Print Report through Browser Menu
49
Preparing for a Study
50
Preparing the System for a Study
50
Connecting the PAT™ Probe
50
Figure 40 - Inserting into Slit
50
Figure 41 - Clicking in
50
Creating/Updating Patient's Record
51
Figure 42 - Press to Release
51
Figure 43 - Probe Disconnected
51
Table 1 - Risk Factors Mandatory Fields
53
Conducting an Endopat TM X Study
54
Pre-Study
54
Patient and System Setup
56
Figure 44 - Applying the PAT™ Probes
57
Figure 45 - Hands Set-Up
57
Performing the Study
58
Figure 46 - Occlusion Quality Assessment
60
Review and Analysis
61
Study Data Retrieval
61
Automatic Analysis
61
Study Report
62
Endopat TM X Study Results
62
Figure 47 - Non Selective Population Histograms of RHI
63
Figure 48 - Non Selective Population Histograms of Lnrhi
63
Figure 49 - Lnrhi Distribution in Non-Selective Population
63
Additional / Research Features
64
Figure 50 - AI Calculation
65
Figure 51 - AI Result (Female Example)
65
Figure 52- Time Domain HRV
66
Figure 53- Frequency Domain HRV
66
Study Printing
67
Maintenance
68
Device Maintenance
68
Troubleshooting
69
Table 2 - Troubleshooting
70
System Error Messages
71
Table 3 - Error Messages
73
Technical Information
74
System Minimum Requirements
74
Operating System
74
Technical Information about Labeling
74
Labeling
77
Specifications of Endopat TM X System
79
Table 4 - Specifications
79
Appendix A: License Agreement and Limited Warranty
80
Appendix B: Regulatory Authorized Representative
81
Appendix C: Manufacturing Declarations According to Iec 60601-1-2
82
Appendix D: Spare Parts List
89

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Itamar Medical OM1695230 Operation Manual (89 pages)

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