Opsens OptoMonitor 3 Manuals

Opsens OptoMonitor 3 Manuals

Manuals and User Guides for Opsens OptoMonitor 3. We have 2 Opsens OptoMonitor 3 manuals available for free PDF download: Instructions For Use Manual

Opsens OptoMonitor 3 Instructions For Use Manual

Opsens OptoMonitor 3 Instructions For Use Manual (122 pages)

Brand: Opsens | Category: Measuring Instruments | Size: 6 MB

Table of Contents

Table of Contents
2
Introduction
8
Indications for Use
9
Intended User
9
Intended Environment
9
Contraindications
9
Safety
9
Warnings
9
Cautions
10
Precautions
11
Notes
11
Storage and Handling
12
Symbols
13
Cybersecurity
15
Compliance with Regulatory Requirements
15
Compliance with Standards and Directives
15
RF Compliance
19
United States
19
Canada
20
Japan
20
Essential Performance
20
Deviation from the Standards
20
Overview of the Optomonitor 3 System
21
Optomonitor 3 Optical Unit (Opm3-OU)
22
Cathlab Interface Cables
22
AUX in (AUX Interface Cable)
23
Aortic in (AO Transducer Interface Cable)
23
Aortic out Cable (Pressure Output Interface Cable)
23
Distal out (Pressure Output Interface Cable)
23
Optomonitor 3 Display Unit (Opm3-DU)
23
Overview of the du
24
Optomonitor 3 Handle Unit (Opm3-HU)
25
Accessories
25
Optowire™ Pressure Guidewire (Not Supplied)
25
Savvywire™ Pressure Guidewire (Not Supplied)
25
Aortic Transducer (Supplied by Others)
26
Audio and LED Indicators
26
Audio Indicators
26
Color Indicators
27
Graphical User Interface
29
Coronary Procedure Main Menu Screen Functions
30
Structural Procedure Main Menu Screen Functions
32
Playback Mode Functions
33
Universal Menu Functions
35
Archive Menu Functions
38
Optomonitor 3 Installation
40
Unpacking the Optomonitor 3 System
40
Mounting the Devices
41
Mounting the Optical Unit
41
Mounting the Display Unit
41
Connecting the Handle Unit
42
Connecting to Mains Supply
43
Connecting to Cathlab Hemodynamic High-Level Aortic Output
43
Connecting to Aortic Transducer (Aortic Input)
43
Connecting Aortic Output to Cathlab Hemodynamic- Compulsory When Using the AO Transducer Interface Cable
44
Connecting Distal Output to Cathlab Hemodynamic- Optional
44
Connecting DICOM
45
Connecting an External Screen
45
Instrument Settings
46
Dpr Mode
46
Dpr Disabled
47
Dpr Enabled
47
TAVI/TAVR Mode
48
Prospective Equalization
48
Hide Patient Info
49
Show ECG
50
Pressure Scale
50
Time Scale
51
Pullback Time Scale
51
Color Selection
52
Audio and Brightness Level
52
Averaging Period
53
Pressure Wire Delay
54
Adjustments Via the Maintenance Menu
55
Accessing the Maintenance Menu
55
Adjusting Time, Date and Language
56
Activation Key
56
Activation Card
57
Activation Management Menu
57
Activating the Software
58
Edit or Remove the Activation Key
58
Patient Case Management
59
Opening a New Case
59
Opening a New Case Without DICOM
59
Opening a New Case from DICOM List
60
Refreshing the DICOM List
61
Ending an Open Case/ Starting a Second Case
61
PERFORMING a PROCEDURE
63
Starting the System
64
Verifying Optimal Aortic Pressure Waveform and Ensuring Ao Zero
64
Using Aortic Input from Cathlab Hemodynamic System
64
Using Aortic Input from the Aortic Transducer (Use with BP-22 Compatible Transducer)
64
Connect the FOIC Connector to the Optomonitor 3 Handle Unit
65
Zeroing Pressure Guidewire to Atmosphere
66
Automatic Zero
66
Manual Zero
66
Equalization
67
Ffr/Dpr Procedure Equalization
67
TAVI/TAVR Procedure Equalization
68
Performing an FFR Procedure
68
Inducing Maximum Hyperemia
68
Recording Pressure - FFR
68
Performing a Dpr Procedure
70
Dpr Calculation
70
Performing a Dpr Pullback
70
Viewing FFR, Dpr, and Pullback in Playback Mode
72
Viewing FFR in Playback Mode
72
Viewing Dpr in Playback Mode
73
Viewing Dpr Pullback in Playback Mode
74
Viewing Pd/Pa Pullback in Playback Mode
75
Performing TAVI/TAVR Procedure
75
When to Record
75
Recording Pressure - TAVI/TAVR
75
Viewing TAVI/TAVR in Playback Mode
76
Select Indices Period
77
Compare/View Screen
78
Playback Gradients and Regurgitation Indicators
78
Playback Functions
81
Creating or Updating Patient Information
81
Ffr/Dpr Notes
82
TAVI/TAVR Notes
84
Reviewing Data
87
Archiving and Deleting Data
87
Terminate Operation
89
Maintenance
90
Accessing the Maintenance Menu
90
Adjusting the Time, Date, and Language
91
Input/Output Calibration with Cathlab Hemodynamic System
91
Calibrating Aortic Input Reference to Aortic Transducer
92
Calibrating Aux Input Reference to Cathlab Hemodynamic System
92
Calibrating Distal Output to Cathlab Hemodynamic System
92
Calibrating Aortic Output to Cathlab System
93
Reviewing Optical Sensor Performance
93
Testing DICOM
94
Testing DICOM
95
Filtering the Modality Worklist
95
Display Information on the Exported Images
95
Security
95
Setting up a Startup Password
96
Changing the Maintenance Access Code
96
Reviewing Message History
97
Reviewing Network and Communication
97
DU LAN1 Connection to DICOM
97
DU-15" LAN2 Connection to the Optical Unit
97
Wireless
98
Software Update for Display Unit or Optical Unit
99
Factory Settings
100
DUMP Logs
100
Adjustable Settings
101
Settings Menu
101
MAINTENANCE MENU Input/Output Calibration
101
MAINTENANCE MENU Security
101
MAINTENANCE MENU Network and Communication
102
Field Service Information
102
General Care and Cleaning
102
Cleaning
102
Optical Unit and Display Unit
103
Handle Unit
103
Optical Connectors
104
Leakage Current Measurement
105
Visual Inspection
105
General Routine Inspection
105
Annual Visual Inspection
105
Disposal
106
Troubleshooting
107
Verify the Connection of the Pressure Guidewire
107
Zeroing Failed
107
Wire Zeroed Twice
107
Aortic Input Zeroing Failed
108
Equalization Failed
108
Pressure Wire Delay Messages
108
Re-Equalized
109
GFC and Optowire™ Mismatch
109
Specifications
110
Technical Specifications
110
Ordering Information
112
Optomonitor 3 System Log - Distal Input Value
113
Appendix A: Optomonitor 3 Installation Instructions
114
Parameters
118
AUX in Calibration Using the Optomonitor 3 and Cathlab Hemodynamic System
118
Pa Input Calibration Using Optomonitor 3 and Aortic Transducer
119
Pd Output Calibration
119
Aortic Output Calibration
119
Installation Acknowledgement
120
Appendix B- Installation Checklist
121

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Opsens OptoMonitor 3 Instructions For Use Manual

Opsens OptoMonitor 3 Instructions For Use Manual (105 pages)

Brand: Opsens | Category: Monitor | Size: 5 MB

Table of Contents

Table of Contents
2
Introduction
8
Indications for Use
9
Intended User
9
Intended Environment
9
Contraindications
9
Safety
9
Warnings
9
Cautions
10
Precautions
11
Notes
11
Storage and Handling
12
Symbols
13
Cybersecurity
14
Compliance with Regulatory Requirements
16
Compliance with Standards and Directives
16
RF Compliance
20
United States
20
Canada
20
Japan
21
Essential Performance
21
Deviation from the Standards
21
Overview of the Optomonitor 3 System
22
Optomonitor 3 Optical Unit (Opm3-OU)
23
Cathlab Interface Cables
23
AUX in (AUX Interface Cable)
24
Aortic in (AO Transducer Interface Cable)
24
Aortic out (Pressure Output Interface Cable)
24
Distal out (Pressure Output Interface Cable)
24
Optomonitor 3 Display Unit (Opm3-DU)
24
Overview of the du
25
Optomonitor 3 Handle Unit (Opm3-HU)
26
Accessories
26
Optowire Pressure Guidewire (Not Supplied)
26
Aortic Transducer (Supplied by Others)
26
Audio and LED Indicators
27
Audio Indicators
27
Color Indicators
28
Graphical User Interface
29
Main Menu Screen Functions
32
Playback Mode Functions
33
Universal Menu Functions
35
Archive Menu Functions
37
Optomonitor 3 Installation
38
Unpacking the Optomonitor 3 System
39
Mountings the Devices
39
Mounting the Devices
39
Mounting the Optical Unit
39
Mounting the Display Unit
39
Connecting the Handle Unit
40
Connecting to Mains Supply
41
Connecting to Cathlab Hemodynamic High-Level Aortic Output
41
Connecting to Aortic Transducer (Aortic Input)
41
Connecting Aortic Output to Cathlab Hemodynamic- Compulsory When Using the AO Transducer Interface Cable
42
Connecting Distal Output to Cathlab Hemodynamic- Optional
42
Connecting DICOM
42
Connecting an External Screen
43
Instrument Settings
44
Dpr Mode
44
Dpr Disabled
44
Dpr Enabled
45
Prospective Equalization
45
Hide Patient Info
46
Pressure Scale
46
Time Scale
47
Pullback Time Scale
47
Pa, Pd, Pd/Pa, Dpr Curves Color Selection
48
Audio and Brightness Level
48
Averaging Period
49
Pd Delay
49
Input/Output Calibration with Cathlab Hemodynamic System, and Time/Date/Language Adjustments Via the Maintenance Menu
51
Accessing the Maintenance Menu
51
Adjusting Time, Date and Language
52
Patient Case Management
53
Opening a New Case
53
Opening a New Case Without DICOM
53
Opening a New Case from DICOM List
54
Refreshing the DICOM List
55
Ending an Open Case/ Starting a Second Case
55
PERFORMING an FFR or Dpr PROCEDURE
56
Starting the System
57
Verifying Optimal Aortic Pressure Waveform and Ensuring Pa Zero
57
Using Aortic Input from Cathlab Hemodynamic System
57
Using Aortic Input from the Aortic Transducer (Use with BP-22 Compatible Transducer)
58
Connect the Optowire Cable FOIC Connector to the Optomonitor 3 Handle Unit
58
Zeroing Optowire to Atmosphere
59
Automatic Zero
59
Manual Zero
59
Equalization
60
Positioning Sensor Distal to Stenosis
60
Performing an FFR Procedure
61
Inducing Maximum Hyperemia
61
Recording Pressure - FFR
61
Performing a Dpr Procedure
62
Dpr Calculation
62
Performing a Dpr Pullback
63
Viewing FFR, Dpr, and Pullback in Playback Mode
64
Viewing FFR in Playback Mode
64
Viewing Dpr in Playback Mode
65
Viewing Dpr Pullback in Playback Mode
66
Viewing Pd/Pa Pullback in Playback Mode
67
Playback Functions
68
Creating or Updating Patient Information
68
Segments
70
Reviewing Data
72
Archiving Data
72
Terminate Operation
72
Maintenance
73
Accessing the Maintenance Menu
73
Adjusting the Time, Date, and Language
74
Input/Output Calibration with Cathlab Hemodynamic System
75
Calibrating Aortic Input Reference to Aortic Transducer
75
Calibrating Aortic Input Reference to Cathlab Hemodynamic System
75
Calibrating Distal Output to Cathlab Hemodynamic System
76
Calibrating Aortic Output to Cathlab System
77
Reviewing Optical Sensor Performance
77
Testing DICOM
79
Filtering the Modality Worklist
79
Display Information on the Exported Images
80
Security
80
Setting up a Startup Password
80
Changing the Maintenance Access Code
81
Reviewing Message History
81
Reviewing Network and Communication
81
DU LAN1 Connection to DICOM
81
DU-15" LAN2 Connection to the Optical Unit
82
Wireless
82
Software Update for Display Unit or Optical Unit
84
Factory Settings
84
DUMP Logs
84
Adjustable Settings
85
Settings Menu
85
MAINTENANCE MENU Input/Output Calibration
86
MAINTENANCE MENU Security
86
MAINTENANCE MENU Network and Communication
87
Field Service Information
87
General Care and Cleaning
88
Cleaning
88
Optical Unit and Display Unit
88
Handle Unit
89
Optical Connectors
89
Leakage Current Measurement
90
Visual Inspection
90
General Routine Inspection
90
Annual Visual Inspection
90
Disposal
91
Troubleshooting
92
Verify the Connection of the Optowire
92
Optowire Zeroing Failed
92
Optowire Zeroed Twice
92
Aortic Input Zeroing Failed
93
Equalization Failed
93
Re-Equalized
93
Resetting Equalization
93
GFC and Optowire Mismatch
93
Specifications
94
Technical Specifications
94
Ordering Information
95
Optomonitor 3 System Log - Distal Input Value
96
Appendix A: Optomonitor 3 Installation Instructions
97
Parameters
101
AUX in Calibration Using the Optomonitor 3 and Cathlab Hemodynamic System
101
Pa Input Calibration Using Optomonitor 3 and Aortic Transducer
102
Pd Output Calibration
103
Aortic Output Calibration
103
Installation Acknowledgement
103
Appendix B- Installation Checklists
104

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