Zeiss PLEX Elite 9000 - Page 36

Zeiss PLEX Elite 9000

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2 Introduction Instructions for Use

2660021169042 Rev. A 2018-032.6 PLEX® Elite 9000 Technology

36 / 246 2660021169042 Rev. A 2018-03

Table of Contents

Default Chapter3
- Table of Contents3
1 Safety and Certifications9
- Symbols and Labels9
- Definitions10
- Safety10
- Product Safety11
- Product Safety14
- Optical Safety17
- Laser Safety and Compliance19
- Electrical Safety19
- Printer and Peripherals Safety19
- Networking Safety21
- Record and Data Safety22
- Electromagnetic Compatibility (EMC)22
- Electromagnetic Emissions23
- Electromagnetic Immunity23
- Operator Training and Equipment Maintenance27
- Operator Training27
- Equipment Maintenance27
- Notification of Serious Incident28
- Rohs Compliance28
2 Introduction29
- Scope29
- Intended Use29
- Indications for Use29
- Usage29
- Essential Performance30
- Subject/Patient Profile30
- Operator Profile30
- Intended Demographic (Operators)30
- Required Occupational Skills (Operators)30
- Job Requirements (Operators)31
- Data Analyst Profile31
- Intended Demographic (Analysts)31
- Required Occupational Skills (Analysts)31
- Job Requirements (Analysts)32
- User Documentation32
- Purpose32
- Access32
- Organization32
- Other Applicable Documents32
- Conventions Used in this Document33
- Questions and Comments33
- PLEX® Elite 9000 Technology33
- New in Version 1.734
- Rev. a34
3 System Overview37
- Hardware Overview37
- Acquisition Device38
- Monitor39
- Network-Attached Storage (NAS)39
- Network Switch40
- Power Table40
- Software Overview40
- Screen Layout41
- Toolbar41
- Navigation44
- Basic Screens46
4 Installation47
- Safety During Installation47
- Installing the Instrument47
- Install Review Station Software48
- Software and Document Media49
- Review Station Requirements49
- Review Station Performance50
- Installing Review Station Software50
- Installing User Documentation53
5 Startup and Shutdown55
- System Startup55
- System Shutdown55
6 Configuring Software57
- System Administration57
- Initial Configuration Checklist57
- Log in as Admin59
- Configuring the Instrument or Review Station59
- Managing User Accounts61
- Managing Patient Categories65
- About Patient Categories65
- Adding a Category66
- Editing a Category66
- Deleting a Category67
- Setting Preferences67
- Setting Archive/Synchronize Alerts67
- Setting the Default Patient Screen68
- Enabling Automatic Worklist Search (DICOM)68
- Setting the Internet Protocol Version69
- Setting the Preventive Maintenance Schedule70
7 Before Every Use71
- Safety During Preparation for Use71
- Prepare the Device for Use72
- Read and Understand Physician Instructions72
8 Operation73
- User Login/Logout73
- Logging in as Operator or Data Analyst73
- Logging out73
- Select the Patient74
- Find an Existing Patient74
- Select from Today's Patients77
- Prepare the Patient78
- Dilating the Patient's Eyes (Optional)78
- Guiding the Patient through the Scan Procedure78
- Determine Scan Type80
- Scan Types80
- Acquire Data (Scan)82
- Acquire Angio Scans, Cube Scans, and HD 51 Scans82
- Acquire HD Spotlight Scans87
- Acquire Montage Angio Data91
- Repeating a Prior Scan (Track to Prior)96
- Check Scan Quality97
- Quality Check Screen (Angio)98
- Quality Check Screen (Montage)100
- Checking Scan Quality101
- Acceptance Criteria102
9 Analyzing Exam Data and Creating Reports107
- Analysis and Report Screen Elements108
- Reports109
- Angiography Analysis Report109
- En Face Report113
- Cube Report115
- OU Cube Report116
- Spotlight Report117
- High Definition Images Report Screen118
- Opening a Report or Analysis120
- Working with Viewport Images120
- Comparing the Current and Prior Scans121
- Verifying the Avascular Slab121
- Hide or Show a Fundus Overlay122
- Editing the Fundus Overay123
- Creating a Custom Slice124
- Editing Images124
- Exporting Images and Movies132
- Rev. a133
- Image Navigation137
- Using Presets142
- About Presets142
- Show or Hide Presets142
- Angiography Analysis Presets143
- Enface and Cube Report Presets146
- Creating Custom Presets149
- Show or Hide the Fundus Image150
- Editing B-Scans150
- Editing Segmentation Results151
- Changing Viewport Layout153
- Exporting a Report or Analysis153
10 Data Management155
- Protection of Patient Health Information155
- Database Selection155
- Select a Database155
- Patient Data156
- Patient Privacy156
- Merge Patients156
- Move Scan157
- Editing Patient Records158
- Edit Patient Records158
- Print Patient Lists158
- Add a New Patient159
- Finding a Worklist Patient Record (DICOM)161
- Data Archiving and Retrieval163
- Setting up an Archive164
- Data Export165
- Data Export Options165
- Patient Identifying Information Omission Options166
- Exporting Data167
- Create, View and Export a Montage169
- Exporting to Montage Editor169
- Create and View a Montage169
- Export a Montage170
- Data Import171
- Data Integrity of Imported Records171
- Importing Data171
- Log Files173
11 Networking175
- Network Capabilities175
- Configuring Windows Automatic Updates176
- Connecting Review Stations to Instrument Data Archives178
- Adding a Network Storage Device179
- NAS Device Requirements179
- Network File Server Minimum Requirements180
- Setting up a Network File Server (External NAS)180
12 Cleaning and Disinfection183
- Safety During Cleaning and Disinfection183
- Cleaning Agents183
- Cleaning Optical Components184
- Brush Cleaning Method184
- Wipe Cleaning Method184
- Dust Cleaning185
- Cleaning Heavy Contamination185
- Cleaning the Chin Cup and Forehead Rest185
- Cleaning Peripherals and Table185
13 Maintenance and Repair187
- Safety During Maintenance187
- Device Access188
- Remove Rear Cover188
- Fan Filter Replacement188
- Performance Verification Check189
- Installing the Verification Test Tool189
- Run the Performance Verification190
- Pass/Fail Conditions194
- Performance Verification Examples195
- Power Entry Module Fuse Replacement203
- Power Table Fuse Replacement204
- Maintenance Schedule206
14 Troubleshooting207
- Safety During Troubleshooting207
- Status Messages208
15 Specifications211
- Imaging Parameters211
- OCT and OCT Angiography Imaging211
- Fundus Imaging212
- Iris Imaging212
- Laser Classification212
- Electrical213
- Mechanical214
- Dell Tower 5810214
- Network Attached Storage214
- Dlink DGS-1008 Switch215
- Rev. a215
- Supporting Power Table216
- Dimensions and Weight216
- Environmental Conditions216
- Environmental Conditions of Use216
- Storage Conditions217
- Transport Conditions217
16 Legal Notices219
- Software Copyright219
- Software License Agreement219
- License Terms and Conditions219
- Acknowledgment220
17 Accessories and User Replaceable Spare Parts221
- Accessories and User Replaceable Parts221
- Parts Orders221
- Domestic Parts Ordering221
- International Service Operations221
- Returning Defective Parts222
- Equipment Return Authorization222
- International Service Operations222
- Part Numbers222
- Power Cords222
- Cables223
- Cleaner223
- Kit, Test Eye223
- Miscellaneous Spare Parts223
18 Decommissioning225
- Safety During Decommissioning225
19 Packaging and Transport227
- Safety During Packaging and Transport227
20 Disposal229
- Packaging Disposal229
- Device Disposal229
  - Glossary231
  - Index233

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