Optos P200TxE - Page 2

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G110230-003-ENG

WARNING

Before using this system:

The system should be used by trained professionals. Before using the system, please

read the operating instructions and safety recommendations in this user guide.

Failure to follow the instructions for use and safety recommendations provided in this

user guide can cause injury to the patient, to the operator, or to other persons.

CAUTION

In the United States of America, Federal law restricts this device to sale by or on the

order of a physician.

Page 2 of 84 Part Number: G110230-003-ENG

Main Page

Table of Contents5
Warnings and Cautions11
General Safety11
Laser Safety13
Electrical Safety14
Environmental Safety15
EMC Safety15
Device Failure16
Cleaning Guidelines16
Maintaining Information Security18
Data Security18
Software on Optos-Supplied Pcs19
Symbol and Label Information19
Introduction21
Device Description21
Clinical Benefits Statement21
Intended Use21
Intended Users22
Target Environment22
Contraindications22
System Configuration22
System Parts23
FIGURE 1: P200Txe Device Connected to Network23
Network Specification and Characteristics24
Image Modalities24
TABLE 1: Network Specification24
FIGURE 2: Network Data Flow24
SLO Imaging Modalities25
OCT Imaging Modalities25
FIGURE 3: Optos OCT Line Scan Example Position and Scan Pattern26
FIGURE 4: Optos OCT Raster Scan Example Area, Scan Pattern and Fixed Center26
FIGURE 5: Optos OCT Retina Scan Example Scan Area and Cross Hairs26
FIGURE 6: Optos OCT Optic Nerve Head Scan Example Target and Scan Lines26
Multi-Mode Workflow27
System Software27
Understanding the Review Software27
Accessories and Detachable Parts28
TABLE 2: List of Parts28
Get Started29
Switch on each Day29
Switch on the Image Server29
Switch on the Scan Head29
Switch on Browser-Based Review Clients30
Use Standby Mode at the End of each Day30
How to Shut down the Scan Head31
Install Software Updates31
Log off the Image Server each Day31
Restart the Image Server each Week32
Use the System32
Using the Touch Screen32
TABLE 3: List of Touch Screen Icons32
Using the Touch Screen Keyboard33
Using the Hand Control33
TABLE 4: List of Hand Control Buttons33
FIGURE 7: Hand Control33
Using the Chin Rest and Head Rest34
FIGURE 8: Chin Rest and Head Rest34
Capture Images35
Selecting and Managing Patient Details35
FIGURE 9: Example Capture and Review Workflow35
Adding a New Patient36
Selecting and Editing Existing Patient36
Selecting a Patient Order from MWL36
Working with Modality Work List (MWL)36
How to Search Using MWL36
How to Prepare for Image Capture36
How to Align the Patient37
Patient Coaching37
Align the Patient37
FIGURE 10: Position of the Canthus Mark on the Covers38
FIGURE 11: Aligned Patient38
How to Capture SLO Images39
What to Do after the Image Is Captured40
How to Capture SLO Eye Steered Images40
TABLE 5: Examples of Eye Steering Buttons40
How to Capture SLO Stereo Images41
TABLE 6: Examples of Stereo Buttons41
How to Capture SLO Angiography Images42
Control Contrast42
How to Capture OCT Images43
FIGURE 12: OCT Capture Workflow43
The Patient's View of OCT Alignment44
How to Optimize OCT Scan Quality44
FIGURE 13: Indication of What the Patient will See When Being Aligned for OCT Imaging44
Capture Scans Quickly and Recapture if Necessary45
Using the Auto-Routines45
Live OCT Positioning45
Minimizing Eye Dryness45
How to Capture an OCT Follow-Up Scan45
How to Check OCT Scans46
TABLE 7: Scan Results46
Artifacts - Low Signal Strength47
FIGURE 14: Examples of Local Weak Signal Strength48
FIGURE 15: Example of Local Weak Signal Near the Fovea48
FIGURE 16: Example of Local Weak Signal with Acceptable Global SNR48
Artifacts - Eye Movements49
Artifacts - Blinks49
FIGURE 17: Possible Movement Detected49
FIGURE 18: Possible Blink Detected49
Artifacts - Clipping50
Artifacts - Alignment of Essential Structures50
How to Capture Using Multi-Mode50
FIGURE 19: Example of Clipped B-Scan50
FIGURE 20: Example of Clipping Near the Fovea50
FIGURE 21: Example of Clipping Near the Optic Disc50
How to Manage the Patient Session51
Review Images53
Starting the Review Software53
How to Start the Application53
Reviewing Patient Images and Scans53
FIGURE 22: Reviewing Images Workflow53
Exiting the Review Software54
Manage the System55
Managing User Details55
How to Create User Accounts for Use on the Scan Head55
How to Create User Accounts on the Image Server55
How to Change Users56
How to Change the Language on the Scan Head56
How to Change the Language Displayed in the Review Application56
Storing and Archiving Images56
Managing Connections56
Managing the Modality Work List56
Quality Checks57
Self-Tests57
Status Indicator57
Software Update57
TABLE 8: List of Status Indicator Lights57
Maintenance and Cleaning59
Servicing59
Warranty59
Cleaning60
General Cleaning60
Cleaning before each Patient61
How to Remove the Head and Chin Rests61
Cleaning the Main Mirror61
Disinfection62
Battery Replacement63
Cable Management63
Troubleshooting65
TABLE 9: List of Problems and Solutions65
Why Can't I Login66
What Information Do I Need When Contacting Optos67
How Do I Image if the Alignment System Does Not Recognize the Eye67
How Do I Restart the Scan Head67
How Do I Restart the Image Server67
What Should I Do if the PC Drive on the Image Server Is Full68
Technical Specification69
Safety Designation (IEC 60601-1)69
Scan Head69
TABLE 10: Scan Head Safety Designation Details69
Connections70
FIGURE 23: Sample of the Connection Label70
Scan Head Dimensions71
Review Client Properties71
Touch Screen Properties71
TABLE 11: Scan Head Dimensions71
TABLE 12: Review Client Properties71
Battery72
Environmental Considerations (Ambient)72
TABLE 13: Touch Screen Properties72
TABLE 14: Table Size Requirements72
Laser Safety Designation (IEC 60825-1)73
External Laser Warning Information73
TABLE 15: Environmental Ranges73
Internal Laser Warning Information74
Electromagnetic Compatibility (EMC)74
Guidance and Manufacturer Declaration - Electromagnetic Emissions74
Guidance and Manufacturer Declaration - Electromagnetic Immunity74
TABLE 16: List of Electromagnetic Emission Compliance74
TABLE 17: List of Electromagnetic Immunity Compliance74
Recommended Separation Distances76
TABLE 18: List of Recommended Separation Distances76
Contact Us79
Global Headquarters79
Regional Offices79
United States and Canada79
Australia80
Denmark80
France80
Germany and Austria80
Norway80
Spain81
Sweden81
Switzerland81
United Kingdom and Other European Countries81
European Authorized Representative82
Patient Alignment Guide83

Optos P200TxE - Page 2

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