Instructions for Use
202 Pages
Preview
Page 1
CLARUS® 700
Instructions for Use
Copyright ©2019, Carl Zeiss Meditec, Dublin, CA Trademarks All Zeiss products mentioned herein are either registered trademarks or trademarks of Carl Zeiss Meditec, Inc. in the United States and/or other countries. Windows, Windows Media, Windows Server, and Microsoft are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Mac OS, iMac, iPad, and QuickTime are either registered trademarks or trademarks of Apple Inc. in the United States and/or other countries. All other trademarks used in this document are the property of their respective owners. Patents http://www.zeiss.com/meditec/en_us/imprint/patents
Instructions for Use CLARUS® 700
Table of Contents
Table of Contents 1
Safety and Certifications ... 9
1.1 1.1.1 1.1.2 1.1.3 1.1.4
Compliance... 9 Laser Safety and Compliance ... 9 Optical Safety ... 9 RoHS Compliance ... 9 Electrical Safety ... 9
1.2
Symbols and Labels ... 10
1.3 1.3.1 1.3.2 1.3.3 1.3.4
Warnings, Cautions, and Notes ... 12 Definitions... 12 Warnings... 12 Cautions... 15 Notes ... 17
1.4
Report Serious Accidents... 18
1.5
Essential Performance ... 18
1.6 1.6.1 1.6.2
Electromagnetic Compatibility (EMC)... 18 Electromagnetic Emissions... 19 Electromagnetic Immunity ... 19
1.7
Wireless Communications... 21
2
Introduction ... 23
2.1 2.1.1 2.1.2
Scope... 23 Intended Use / Indications for Use ... 23 Contraindications for Angiography ... 23
2.2
Usage ... 23
2.3 2.3.1 2.3.2 2.3.3 2.3.4
Intended Audience ... 23 Patient Profile... 24 Operator Profile... 24 Doctor Profile ... 24 Administrator Profile ... 24
2.4 2.4.1 2.4.2 2.4.3
User Documentation... 25 Purpose... 25 Access ... 25 Conventions Used in This Document... 25
2.5
Questions and Comments ... 26
2.6 2.6.1 2.6.2 2.6.3 2.6.4
System Overview ... 26 System Description ... 26 Hardware Overview... 27 Application Overview ... 30 Networking Overview... 37
3
Installation ... 39
3.1 3.1.1
Hardware Installation ... 39 Preparing to Install ... 40
2660021170014 Rev. C 06-2019
3 / 202
Table of Contents
Instructions for Use CLARUS® 700
3.2 3.2.1 3.2.2 3.2.3
Software Installation ... 40 Preparing to Install Software ... 40 Installing Review Software... 41 Upgrading Instrument Software and the Review Application ... 45
4
Daily Startup ... 47
4.1
Turn on the Instrument ... 47
4.2
Logging In ... 47
5
Configuration ... 49
5.1
About User Roles ... 49
5.2
Opening Settings ... 49
5.3
Setting All Options ... 50
5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5
Managing Data... 51 Manage Patient Records... 51 Manage Users ... 66 Manage Backups ... 69 Log Files ... 72 Data Storage ... 72
5.5 5.5.1 5.5.2 5.5.3
Managing Connections ... 73 Connecting to a Wireless Printer... 73 Mapping Networked Drives ... 74 Connecting to a LAN ... 74
5.6
Managing Licenses ... 75
5.6.1 5.6.2 5.6.3 5.6.4
Activating Licenses Online ... 76 Activating Licenses Offline... 76 Returning Product Licenses... 78 Repairing Product Licenses ... 81
5.7
Configuring Local Settings... 82
5.8
Configuring Report Settings ... 83
5.9
Configuring Acquisition Settings ... 84
5.10
Clearing Alert History ... 85
5.11 5.11.1 5.11.2 5.11.3 5.11.4
System Administration ... 86 Windows Patches and Updates ... 86 Data Safety... 86 Networking ... 87 Windows 10 System Administration ... 89
6
Operation ... 101
6.1
Safety During Operation ... 101
6.2 6.2.1 6.2.2 6.2.3
Preparing the Device ... 101 Retrieving Images from FORUM in Advance... 102 Finding a Patient ... 102 Selecting the Patient... 102
6.3
Preparing the Patient ... 103
4 / 202
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
Table of Contents
6.3.1 6.3.2 6.3.3 6.3.4
Dilating the Patient’s Eyes (Optional) ... 103 Lifting the Patient's Eyelid (Optional) ... 104 Positioning the Patient ... 104 Aligning and Focusing on the Patient's Eye... 106
6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.4.9
Acquire Images... 108 About Acquisition... 108 Capturing a Widefield Image ... 113 Capturing an Ultra-widefield Image (2-Image Montage) ... 114 Capturing an AutoMontage Image (4-Image Montage) ... 115 Capturing a Montage Image (2-6 Images) ... 117 Capturing a Stereo Image... 118 Capturing an External Eye Image ... 119 Capturing a Fluorescein Angiography (FA) Image Series... 120 Common Acquire Tasks ... 123
6.5
Analyze Images ... 127
6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.5.8 6.5.9 6.5.10 6.5.11 6.5.12 6.5.13
About Image Analysis... 127 Proof ... 129 Review ... 129 Analyze an FA Image Series ... 130 Opening the Analyze Window ... 132 Sorting and Selecting Images... 133 Hiding or Showing Image Details... 134 Editing Images... 135 Manually Creating a Montage ... 149 Locating the Optic Nerve Head... 150 Viewing Stereo Images ... 151 Saving Edited Images... 151 Creating a Report ... 152
7
Shutdown... 155
7.1
Logging Off ... 155
7.2
Shutting Down ... 155
8
Cleaning and Disinfection... 157
8.1
Safety During Cleaning ... 157
8.2
Cleaning Agents ... 157
8.3 8.3.1 8.3.2 8.3.3
Cleaning the Front Lens... 157 Removing Fluid Splashes... 157 Removing Minor Dust Accumulation ... 157 Removing Severe Contamination ... 158
8.4 8.4.1 8.4.2 8.4.3 8.4.4
Cleaning the Front Window Lens... 159 Cleaning Heavy Contamination... 159 Brush Cleaning Method ... 159 Wipe Cleaning Method... 160 Dust Cleaning... 160
8.5
Cleaning the Chinrest and Forehead Support ... 161
8.6
Peripherals and Table ... 161
8.7
Cleaning the PC Screen... 161
2660021170014 Rev. C 06-2019
5 / 202
Table of Contents
Instructions for Use CLARUS® 700
9
Troubleshooting... 163
9.1
Safety During Troubleshooting... 163
9.2 9.2.1 9.2.2 9.2.3 9.2.4 9.2.5 9.2.6
Error Messages ... 164 System Startup Errors ... 164 Import Error Messages ... 164 Export Error Messages... 165 Networking Error Messages... 165 Montage Error Messages... 166 Other Error Messages ... 166
9.3
Information Messages ... 167
9.4
Installation Troubleshooting... 169
9.5
Image Quality Troubleshooting ... 170
9.6
Connection Troubleshooting... 171
10
Specifications ... 173
10.1
Electrical Specifications ... 173
10.2
Instrument Specifications ... 173
10.3
Dimensions and Weight... 173
10.4
Ambient Requirements ... 174
10.5
Fundus Camera Specifications ... 174
10.6
Laser Classification ... 174
11
Legal Notices ... 175
12
Accessories and User-Replaceable Parts... 177
12.1 12.1.1 12.1.2
Parts Orders ... 177 U.S. Domestic Parts Ordering... 177 International Service Operations ... 177
12.2
Accessory Kit Parts List (Replaceable Parts)... 178
12.3
Additional Replaceable Parts ... 179
12.4 12.4.1 12.4.2
Returning Defective Parts ... 180 Equipment Return Authorization ... 180 Packing for Shipment ... 180
13
Decommissioning ... 181
13.1
Safety During Decommissioning ... 181
14
Packaging and Transport ... 183
14.1
Safety During Transport ... 183
14.2
Instrument Disposal... 183
15
Disposal ... 185
6 / 202
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
Table of Contents
15.1
Packaging Disposal... 185
15.2
Device Disposal... 185
Index ... 191
2660021170014 Rev. C 06-2019
7 / 202
Empty page, for your notes
Instructions for Use CLARUS® 700
1 Safety and Certifications 1.1 Compliance
1 Safety and Certifications 1.1 Compliance CLARUS® 700 instruments from ZEISS are compliant with ISO 10940:2009 and ISO 15004-1:2006.
1.1.1 Laser Safety and Compliance
1.1.2 Optical Safety CLARUS® 700 is compliant with the following optical safety standards: • IEC 60825-1 • ANSI Z80.36 • ISO 15004-2 • Classification: Group 1 Instrument - Per ANSI Z80.36 and ISO 15004-2 Group 1 instruments are ophthalmic instruments for which no potential light hazard exists. • Class 1 Laser Product – Per IEC 60825-1.
1.1.3 RoHS Compliance The product is RoHS-compliant according to Directive 2011/65/EU.
1.1.4 Electrical Safety Electrical Safety Class I Equipment - Protection against electrical shock (per IEC 60601-1).
2660021170014 Rev. C 06-2019
9 / 202
1 Safety and Certifications 1.2 Symbols and Labels
Instructions for Use CLARUS® 700
1.2 Symbols and Labels Symbol
Meaning Warning
Caution
Note
Electricity
Must follow Instructions for Use
Power On (computer)
Power Off (computer)
Protective Earth
Fuse Direct Current Type B Applied Parts
10 / 202
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
Symbol
1 Safety and Certifications 1.2 Symbols and Labels
Meaning Manufacturer Authorized European Community Representative
Serial Number
Catalog Number/Part Number
Model Number Certification mark of CSA – Nationally Recognized Testing Laboratory for US and Canada
Disposal of the Product within the E.U. Do not dispose via domestic waste disposal system or communal waste disposal facility.
Fragile
Keep Dry
This End Up
2660021170014 Rev. C 06-2019
11 / 202
1 Safety and Certifications 1.3 Warnings, Cautions, and Notes
Symbol
Instructions for Use CLARUS® 700
Meaning Transport conditions: humidity (10% to 95%)
Transport conditions: temperature (-40°C to 70°C)
Transport conditions: atmospheric pressure (500 hPa to 1060 hPa)
Caution: Federal law (or United States) restricts this device to sale by or on the order of a licensed healthcare practitioner
1.3 Warnings, Cautions, and Notes 1.3.1 Definitions Warnings and cautions are defined as follows:
WARNING!
Indicates hazards that, if not avoided, could cause severe injury or death. u
CAUTION!
These are actions that can be taken to prevent the hazard.
Indicates hazards that, if not avoided, could cause minor or moderate injury. u
These are actions that can be taken to prevent the hazard.
1.3.2 Warnings
WARNING!
Opening the device covers may result in injury. u
12 / 202
Only ZEISS authorized service technicians may remove device covers.
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
WARNING!
1 Safety and Certifications 1.3 Warnings, Cautions, and Notes
Tipping the device may result in injury. u
WARNING!
WARNING!
Modifying this device may increase risks and decrease the service life of the device. u
Do not use in the presence of flammable gasses.
u
Do not use in oxygen rich environments.
Using this device in the presence of flammable gases may cause ignition and result in a fire hazard. u
WARNING!
Do not allow the patient to lean on the table or use it as a support to stand up.
Do not use this device in the presence of flammable anesthetics or oxidizers such as pure oxygen or nitrous oxide.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. u
WARNING!
If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. u
WARNING!
2660021170014 Rev. C 06-2019
Use only the accessories, transducers, and cables specified or provided by ZEISS.
Adding peripheral equipment or replacing parts may result in noncompliance with the safety requirements of IEC 60601-1. u
You are responsible for ensuring that the system meets the safety requirements of IEC 60601-1.
u
Only approved equipment to their respective IEC/ISO standards such as IEC 60601-1 or IEC 60950 are allowed to be connected to the Signal Input/Output parts (SIP/SOPs).
u
Place any AC-powered, non-medical device peripherals at least 1.5 m away from the instrument and connect them to a separation device, unless an isolation transformer is used.
13 / 202
1 Safety and Certifications 1.3 Warnings, Cautions, and Notes
WARNING!
Instructions for Use CLARUS® 700
Unplugging the power cord is the means of disconnecting from the power supply. Blocking access to the plug may result in an electrical hazard. u
WARNING!
WARNING!
WARNING!
Using parts that are not authorized by ZEISS may compromise device safety during operation. u
Use only accessories authorized by ZEISS.
u
In the U.S., call 800–341–6968. Outside the U.S., contact your local Zeiss distributor. You can find the ZEISS contact partner for your country on our website: www.zeiss.com.
Invisible Class 3B Laser Radiation Max 200mW @ 784nm. This instrument incorporates a Class 3B Laser and exposure to potentially hazardous invisible laser radiation is possible. u
Avoid direct eye exposure. Protective eyewear required.
u
Do not open the acquisition head cover to avoid exposure to Class 3B laser beam.
u
Do not disassemble the Light Box while the laser is energized. In the case that the Light Box is disassembled with the laser energized, protective eyewear is required. See your manager.
Contact with the patient and a peripheral device may cause an electric shock. u
WARNING!
Set up the instrument so that it can be unplugged easily.
Do not touch the patient and a peripheral device at the same time.
Device produces visual stimuli, including flickering light and flashing patterns, between 5 and 65 Hz may adversely affect certain patients, although this effect is yet unproven. u
14 / 202
Medical professionals need to determine whether this device should be used for patients who may be photosensitive, including those with epilepsy.
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
1 Safety and Certifications 1.3 Warnings, Cautions, and Notes
Unqualified personnel
WARNING!
may injure themselves or cause damage to the instrument. u
Only trained, qualified personnel may use this device.
u
This device may be used only for its intended purpose.
u
Only ZEISS authorized personnel may perform maintenance or repair procedures not described in this manual.
Use of the acquisition device, a printer, or the power table with an extension cord or a power strip (multiple portable socket outlet)
WARNING!
could cause electrical shock to the patient or operator. u
Do not use extension cords with the instrument.
u
If you plug something other than an instrument into the Multiple Socket Outlet (MSO), the MSO may not have the designed level of safety.
u
Do not use power strips with the instrument.
u
Do not plug in any other equipment into the same wall outlet as the instrument.
u
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
1.3.3 Cautions
CAUTION!
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous optical radiation exposure.
CAUTION!
Attempting to carry out activities not specifically endorsed by ZEISS may void your warranty and could result in damage to the instrument.
CAUTION!
u
Read the user documentation.
u
Follow directions carefully.
u
Do not make upgrades, or carry out repairs or modifications, without specific guidance and instruction from ZEISS or an authorized ZEISS represenative.
Improper cleaning may result in inadequately disinfected equipment. u
2660021170014 Rev. C 06-2019
Refer to the cleaning instructions in this Instructions for Use and local and national disinfecting regulations.
15 / 202
1 Safety and Certifications 1.3 Warnings, Cautions, and Notes
CAUTION!
CAUTION!
Instructions for Use CLARUS® 700
Connecting the instrument to the Internet increases its vulnerability to serious security risks, including viruses and worms that could disable your system or adversely affect its performance and may void the instrument warranty. u
Transfer data through internal networks.
u
Ensure that all firewalls and internet security applications are up-to-date and running.
u
Connecting the device to the internet or transferring data via USB devices may result in compromised patient privacy and expose the network to malware.
Installing or putting the device into service without regard to EMC information provided may void your Device warranty, result in damage to the instrument and/or compromise safety for patients and operators. u
CAUTION!
This instrument has special EMC precaution requirements and needs to be installed and put into service according to the EMC information provided herein.
Using this instrument with patients who are light-sensitive, including epileptics may cause nausea or harm to the patient.
CAUTION!
CAUTION!
CAUTION!
Attempting to decommission your system may result in damaged equipment and danger to personnel. u
Never attempt to decommission a ZEISS system or instrument. Only ZEISS approved representatives are qualified to safely decommission your system.
u
Contact your ZEISS approved representatives to set up an appointment for system or instrument decommissioning.
Packaging and transport by non-ZEISS personnel could result in damage, loss, or non-compliance within the country of transit. u
Allow only change to Zeiss approved representative to prepare the instrument and associated components for transport.
u
Allow only ZEISS-approved personnel to transport the instrument and associated components.
Do not lift or carry the instrument using the patient support. The patient support could break if used as a carrying handle. u
16 / 202
Make sure you support the instrument from the base whenever you carry the instrument.
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
1 Safety and Certifications 1.3 Warnings, Cautions, and Notes
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
CAUTION!
should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. u
Otherwise, degradation of the performance of this equipment could result.
This instrument is intended for use in a professional healthcare facility environment.
CAUTION!
Using the instrument in any other environment may void the warranty and compromises the safety of the patient and/or operator. Image Degradation
CAUTION!
If image quality is degraded or image is absent from display, please contact Zeiss customer service. u
The physician must decide whether the image is appropriate for diagnosis
Injected dye can have side effects for some patients.
CAUTION!
Adverse patient reactions to dye can interfere with FA image series completion or require a second FA image series (including dye injection). u
Read all dye manufacturer’s documentation carefully.
u
Heed all information regarding dye side effects and contraindications.
u
If repeating an FA image series, consult the manufacturer's documentation regarding contraindications before additional dye injections.
1.3.4 Notes
NOTE
Transferring data via USB devices may result in compromised patient privacy and expose the network to malware. u
2660021170014 Rev. C 06-2019
Use access controls to ensure that only authorized personnel use the device.
17 / 202
1 Safety and Certifications 1.4 Report Serious Accidents
NOTE
Instructions for Use CLARUS® 700
Connecting the device to a network that includes other equipment may result in previously unidentified risks.
NOTE
u
You are responsible for analyzing and controlling these risks.
u
You must reassess these risks when you make any changes to the network, including connecting, disconnecting, or upgrading equipment.
Unprotected devices may be at risk from unauthorized individuals. u
Select and set the Password strength setting in the User management screen.
1.4 Report Serious Accidents Report any serious incident related to this instrument, the operator, patient, or anyone else: • To the instrument manufacturer or distributor. • (European Union only) To the competent authority in the state where the instrument operator is established.
1.5 Essential Performance The main clinical performance of the CLARUS® 700 instrument is to capture, display and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. Since there are no surgical or treatment decisions made solely on data obtained by the instrument, it was determined that the CLARUS® 700 has no “essential performance” as defined in IEC 60601-1 standard.
1.6 Electromagnetic Compatibility (EMC) WARNING!
Installing or putting the device into service without regard to EMC information provided may void your ZEISS instrument warranty, result in damage to the instrument and/or compromise safety for patients and operators. u
18 / 202
This instrument has special EMC precaution requirements and needs to be installed and put into service according to the EMC information provided herein.
2660021170014 Rev. C 06-2019
Instructions for Use CLARUS® 700
1 Safety and Certifications 1.6 Electromagnetic Compatibility (EMC)
This instrument is intended for use in a professional healthcare facility environment.
CAUTION!
Using the instrument in any other environment may void the warranty and compromises the safety of the patient and/or operator. The emissions characteristics of this equipment
NOTE
make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). u
If it is used in a residential environment, this equipment might not offer adequate protection to radio-frequency communication services.
u
The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
Electromagnetic Emissions [} 19] and Electromagnetic Immunity [} 19] are required per IEC 60601-1-2:2014.
1.6.1 Electromagnetic Emissions This instrument complies with the following emission requirements: Phenomenon
Standard
Conducted and radiated RF emissions
Group 1 CISPR 11 Class A
Harmonic distortion
IEC 61000-3-2 Class A
Voltage fluctuations and flicker
IEC 61000-3-3: Complies
Table 1: Electromagnetic Emissions
1.6.2 Electromagnetic Immunity This instrument complies with the following immunity requirements: Phenomenon
Basic EMC standard or test method
Immunity test levels
Electrostatic Discharge
IEC 61000-4-2
± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields
IEC 61000-4-3
3 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz
Proximity fields from RF wireless communications equipment
IEC 61000-4-3
See Wireless Communications [} 21]
Rated power frequency magnetic fields
IEC 61000-4-8
30 A/m 50 Hz or 60 Hz
2660021170014 Rev. C 06-2019
19 / 202
1 Safety and Certifications 1.6 Electromagnetic Compatibility (EMC)
Instructions for Use CLARUS® 700
Phenomenon
Basic EMC standard or test method
Immunity test levels
Electrical fast transients / bursts
IEC 61000-4-4
± 2 kV 100 kHz repetition frequency
Surges line-to-line
IEC 61000-4-5
± 0,5 kV, ± 1 kV
Surges line-to-ground
IEC 61000-4-5
± 0,5 kV,± 1 kV, ± 2 kV
Conducted disturbances induced by RF fields
IEC 61000-4-6
3V 0,15 MHz – 80 MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
Voltage dips, short interruptions, and voltage variations on power supply input lines
IEC 61000-4-11
0 % UT1; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT1; 1 cycle and 70 % UT1; 25/30 cycles Single phase: at 0°
Voltage Interruptions
IEC 61000-4-11
0 % UT1; 250/300 cycle
Table 2: Electomagnetic Immunity 1
20 / 202
UT is the a.c. mains voltage prior to application of the test level.
2660021170014 Rev. C 06-2019