Visante OCT Model 1000 System Software User Manual Ver 3.0

Contents iii Contents (1) Introduction ...1-1 •Intended Use ...1-1 •Indications for Use...1-1 •Purpose of This User Manual...1-1 •Visante OCT Technology... 1-3 •Visante OCT System Hardware... 1-4 •WARNING: User Changes to Software or Hardware ... 1-5 •Instrument Installation ... 1-5 •Tips to Avoid Damage... 1-5 •Embedded Windows License ... 1-6 •Product Compliance... 1-6 •Product Safety ... 1-6 •Electromagnetic Compatibility (EMC) ... 1-8 •Accessory Equipment...1-11 •Symbols and Labels ... 1-12 •Instrument Disposition ... 1-15 •Disposal... 1-15 (2) Operational Overview ... 2-1 •Chapter Overview ... 2-1 •System Start and Login... 2-1 •Initial System Setup ...2-4 •Operational Modes and Windows ...2-8 •Basic Screen Layout ...2-9 •Performance Verification Check...2-16 •Power Down the System...2-19 (3) Acquire Scans... 3-1 •Chapter Overview ... 3-1 •Prepare The Patient ... 3-1 •Identify a Patient ...3-2 •Select Exam Protocol ...3-6 •Align Eye and Acquire Scan ... 3-7 •Review Scan: Save or Try Again ...3-14 •Optional Adjustments Before Acquisition... 3-21 (4) Exam Protocols and Scan Types ... 4-1 •Chapter Overview ... 4-1 •Exam Protocols ... 4-1 •Exam Protocols Dialog...4-4 •Scan Types ...4-8 (5) Scan Analysis ... 5-1 •Chapter Overview ... 5-1 •Access Analysis... 5-1 •The Analysis Window...5-3

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Contents •Tool Palettes ...5-9 •Analyzing Anterior Segment Scans ... 5-10 •Analyzing High Res Corneal Scans... 5-21 •Advanced Pachymetry Analysis ... 5-24 •Comprehensive Topography Analysis (Optional)...5-30 •ATLAS Review Analysis ...5-42 •Presentation Export ... 5-43 •Printing...5-44 •Sample Reports ...5-45 (6) Data Management... 6-1 •Chapter Overview ... 6-1 •The admin User... 6-1 •Create Institution Name and Logo...6-2 •Staff Registration...6-3 •Equipment: Create a Station Name...6-6 •Record Search...6-6 •Create, Edit and Delete Patient Records ... 6-10 •Merge Patient Records ...6-15 •Categorize Patient Records...6-17 (7) Archive Management... 7-1 •Chapter Overview ...7-1 •The Patient Database...7-1 •Data Maintenance Requirements ... 7-2 •Clear Exam Data ... 7-3 •Archive/Synchronize Recommendations ... 7-4 •Archive/Synchronize Management... 7-8 •Manual Archive ...7-18 •Retrieve Archived Exams ...7-19 (8) Export and Import ... 8-1 •Chapter Overview ... 8-1 •Privacy and Data Integrity Features... 8-1 •Importing/Exporting Patient Data and Exams ...8-2 •Export Data ...8-2 •Import Data ...8-8 (9) Routine Maintenance... 9-1 •Chapter Overview ... 9-1 •Fuse Replacement... 9-1 •Handling Error Messages...9-4 •Hard Disk Defragmentation ...9-5 •Routine Cleaning ...9-5 •List of User Replacement Accessories ... 9-7

Visante OCT User Manual

Contents v (10) Specifications ...10-1 (11) Legal Notices...11-1 •Limited Warranty ...11-1 •Service Contract... 11-2 •Software Copyright... 11-3 •Software License Agreement ... 11-3 (A) Connect ATLAS Instrument to Visante OCT (Optional) ... A-1 •Overview... A-1 •Connect to ATLAS Model 9000 Instrument ... A-1 •Connect to ATLAS Model 900 Series Instrument...A-3 •Map a Drive Letter to a Network Drive/Shared Folder ...A-4 (B) Image Exporter 3.0... B-1 •Overview... B-1 •Launch Image Exporter...B-2 •Configuration: Select Source Database and Output Directory ...B-3 •Patient Selection: Search and Select Patients ...B-4 •Exam Selection: Select Images for Export by Exam Criteria ...B-6 •Export ... B-7 (C) DICOM Gateway (Optional) ... C-1 •Overview... C-1 •DICOM Gateway Configuration Steps ...C-2 •Network Broker Installation...C-3 •Network Broker Configuration...C-6 •Launching the Configuration Tool... C-7 •General Information ...C-8 •Network Broker Configuration Tool Steps... C-10 •Importing Patients from DICOM Worklists...C-22 •Exporting Exams and Reports to a DICOM Storage Provider ...C-23 (D) Networking Guidelines...D-1 •Notice ...D-1 •Network Capabilities ...D-1 •WARNING: Risks of Internet Connectivity...D-1 •Security Recommendations ...D-1 •Prohibited Activities ... D-5 •Network Activities Not Supported ... D-5 •Network File Server Minimum Requirements... D-6 •Network File Server Recommendations ... D-6 •Using the Network File Server ... D-6 •Configuration for Direct Export to a Personal Computer ... D-9 (E) Data Transfer Using Optical Disks ... E-1 •Overview... E-1 •Compatible Media Formats ... E-1 •Compatible Data Transfer Functions... E-1

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Contents •Visante OCT Data Transfer Instructions... E-2 •Proper Disk Care ... E-2 •Disk Formatting ... E-2 •Roxio Drag-to-Disc Software Configuration... E-5 (F) Network Storage Device Configuration ... F-1 •Introduction... F-1 •NAS Device Safety Warnings ... F-1 •NAS Device Requirements ... F-2 •NAS Device Recommendations... F-2 •Install and Configure the NAS Device ... F-3 •Cleaning the NAS Device ... F-6 (G) Printer Configuration ...G-1 •Introduction...G-1 •Approved Printers...G-1 •Printer Safety Warnings... G-2 •Installation Overview... G-2 •Network Configuration ... G-3 •USB Configuration ... G-3 •Peer-to-Peer Wireless Configuration... G-4 (H) License Registration ...H-1 •Registering Optional Features ...H-1 (I)

Database Repair ... I-1

(J) Measurement Data...J-1 •Visante OCT Accuracy, Repeatability and Reproducibility... J-1 •Pachymetry Data ...J-3 •LASIK Flap and Stroma Data...J-5 (K) Index ... K-1

Visante OCT User Manual

Introduction 1-1 (1) Introduction The ZEISS Visante™ OCT Model 1000 (Visante™ OCT) enables detailed in vivo examination of the anterior segment of the eye, without eye contact. The name Visante™ (“VISion-ANTErior”) highlights its numerous applications for enhancing vision as it relates to the anterior eye. Employing the advanced imaging technology of optical coherence tomography, Visante OCT enables you to visualize anterior eye structures with high-resolution, direct cross-sectional images, which can be analyzed, measured and used for evaluation. Visante OCT minimizes patient discomfort as it permits in vivo imaging and biometric measurement of the cornea, the anterior segment and the anterior chamber angle.

Intended Use The Visante OCT is intended for use in viewing and imaging of anterior segment ocular structures.

Indications for Use The Visante OCT is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal and LASIK flap thickness. The Visante OCT is not intended to be used as the sole diagnostic ☞ Note: for disease. It has not been evaluated by the FDA for the diagnosis of specific pathologies.

Purpose of This User Manual Carl Zeiss Meditec designed this User Manual to serve as a training, usage and reference guide. We assume that users are clinicians or technicians with professional training or experience in the use of ophthalmic imaging equipment, and in diagnostic interpretation of the images generated. While we offer training in the use of the Visante OCT, we do not offer instruction in diagnostic interpretation of the images generated. This manual does not attempt to do so. Organization of the Manual This introductory chapter provides a system description, installation and safety information. Chapters (2) through (5) are organized according to the normal sequence of operation of the Visante OCT, followed by data management and data transfer functions in Chapters (6) and (7), as follows: • Operational Overview, explained in Chapter (2). • Acquire Scans, explained in Chapter (3). • Exam Protocols and Scan Types, described in Chapter (4).

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Introduction • Scan Analysis, explained in Chapter (5). • Data Management, explained in Chapter (6). • Archive Management, explained in Chapter (7). Chapters (9), (10) and (11) cover Routine Maintenance, instrument Specifications and Legal Notices, respectively. Users who wish to use the Visante OCT in a networked environment should see (C) DICOM Gateway (Optional), (D) Networking Guidelines, and (F) Network Storage Device Configuration. (G) Printer Configuration provides instructions to use a printer in the wireless, USB or network configuration. (J) Measurement Data provides background clinical data. The manual includes an Index. Text Conventions • This manual means “left-click” when it says, “click,” except where “right-click” is specified. • Chains of menu items are indicated with the use of the “>” symbol between items. For example, “File > Exit” directs you to select Exit in the File menu. Access Menu Options To access the options offered through each menu, click on the menu headings. Then click on an option to select it. Click outside all menu options to make the options disappear. • Some menus are fields tagged with a down-arrow (drop-down lists). To access these menu options, click on the down-arrow. • Grayed-out menu options or buttons are not available. Electronic User Manual Access The Visante OCT User Manual is provided with the instrument electronically in two ways: 1. On CD: Included in the instrument accessory kit. You can view the user manual PDF either using the Visante system computer, or any other computer. 2. On the computer desktop: To access the computer desktop without exiting the system software: A. Press Ctrl+Esc on the keyboard. The Start button and Task Bar will appear along the bottom of the screen. B. Click the Show Desktop button in the Quick Launch area at lower left, next to the Start button. C. Double-click on the desktop shortcut to launch a PDF of the user manual.

Once opened, you can switch between the user manual and the Visante ☞ Note: application by pressing Alt+Tab.

Visante OCT User Manual

Introduction 1-3 Visante OCT Technology The Visante OCT is computerized instrument that acquires and analyzes cross-sectional tomograms of the anterior eye segment (cornea, anterior chamber, iris and the central portion of the lens). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Visante OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. In low-coherence interferometry, light is sent along two optical paths, one being the sample path (into the eye) and the other the reference path of the interferometer. The light source is a 1310 nm superluminescent light emitting diode (SLD), which wavelength has a limited penetration depth into the eye. Light returning from the sample and reference paths are combined at the photodetector. Because of the short coherence length of the SLD, the strength of the combined return signal is a measure of the reflectance of a small volume of tissue at each location of the scanning spot. By varying the optical length of the reference path, the interferometer parses the return signal at each scanning spot to determine the axial depth of the tissue reflectivity signal (analogous to an ultrasound A-scan). By moving the scanning spot laterally across the eye, Visante OCT acquires multiple A-scans and aligns them to construct 2-dimensional images (analogous to an ultrasound B-scan). Tomograms are stored on the computer and/or on an archive medium, and can be quantitatively analyzed. A video camera monitors the eye and the path taken by the scanning spot.

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Introduction Visante OCT System Hardware With the exception of the keyboard, mouse and printer., the Visante OCT integrates all hardware components in a unit, which includes the scan acquisition optics, the interferometer, the system computer and video monitor. Carl Zeiss Meditec offers optional wheelchair accessible motorized power tables (one shown below), which accommodate elevation adjustment to each patient's height. The illustration below labels hardware elements. System specifications are in Chapter (10). Head Rest

External Fixation Port Imaging Aperture

Integrated Video Monitor

Connectors (USB, network, etc.) and labels under rear cover

Dual Chin Rest with Automatic Right/Left Sensors

Table Height Controls

3-D Motorized Patient Alignment Unit

(Optional) Power Table System Power Switch

Keyboard

Mouse

Figure 1-1 Visante OCT System Hardware Software All software necessary to operate the Visante OCT is pre-installed. Software updates with installation instructions may be provided on CD or on our website. Data Storage Storage of Visante OCT exam data is designed to occur in a network environment. We recommend archiving data to a network file server or an network attached storage device (also known as a network hard drive), which operates just as a network file server. For more information, see Chapter (7) Archive Management and (D) Networking Guidelines.

Visante OCT User Manual

Introduction 1-5 WARNING: User Changes to Software or Hardware The Visante OCT is a medical device. The software and hardware have been designed in accordance with U.S., European and other international medical device standards designed to protect clinicians, users and patients from potential harm caused by mechanical, diagnostic or therapeutic failures. Unauthorized modification of Visante OCT software or hardware (including peripherals) can jeopardize the safety of operators and patients, the performance of the instrument, and the integrity of patient data; it also voids the instrument warranty. Approved Software Use of software supplied or approved by Carl Zeiss Meditec for the Visante OCT is authorized. Please refer to the Visante OCT Technical Support section of our website (www.meditec.zeiss.com/visante) for the current list of approved software. Carl Zeiss Meditec does not provide technical support for the use of ☞ Note: unapproved third party software.

Instrument Installation Only an authorized Carl Zeiss Meditec service representative should install the Visante OCT. We do not provide assembly and installation instructions. In consultation with the buyer, Carl Zeiss Meditec schedules a free on-site installation appointment to coincide with delivery. System installation and initial calibration require approximately one business day. Care in Handling Use extreme care when handling and transporting the Visante OCT shipping boxes. The instrument contains fragile optics that require high precision alignment. Installation Requirements • The Visante OCT should operate on a dedicated power outlet. Based on your specification, we configure your Visante OCT at the factory to use either 100V, 115V, or 230V line voltage.

Tips to Avoid Damage Users are not authorized to dismantle (except to remove the rear cover) or ☞ Note: modify the Visante OCT hardware. To transport the instrument outside the office, you must consult with a Carl Zeiss Meditec service technician. Failure to do so voids all warranties offered with the Visante OCT. • Only Carl Zeiss Meditec authorized technicians should disassemble or service this instrument. In the case of malfunction, error messages or operational problems, call Carl Zeiss Meditec customer service: In the U.S., call 800-341-6968. Outside the U.S., contact your local CZM distributor.

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Introduction • This instrument has no special measures to protect against harmful ingress of water or other liquids (classified IPXO-ordinary equipment). Do not place containers of liquid on or near the instrument, nor use aerosols on or near it. • In case of emergency related to the instrument, unplug the power cord from the wall outlet and call for service immediately. • With the exception of the main power fuses, there are no user-replaceable parts in the instrument. For the replacement of any component, accessory, or peripheral, except fuses, call Carl Zeiss Meditec customer service: In the U.S., call 800-341-6968. Outside the U.S., contact your local CZM distributor. • Although this instrument is designed for continuous operation, it should be turned off when not in use for an extended period.

Embedded Windows License Each Visante OCT instrument is issued with an embedded Windows license located under the rear cover.

Product Compliance Complies with 93/42/EEC Medical Device Directive. 0297

Complies with US and Canadian medical electrical system safety requirements.

Product Safety • IEC 60601-1 • UL 60601-1 • CSA C22.2 No. 601.1-M90 This instrument is classified as follows: • Class I Equipment – Protection against electrical shock. • Type B – Degree of protection against electric shock of applied part (chin and forehead rests). • Ordinary Equipment (IPX0)– Degree of protection against ingress of liquids (none). • Continuous Operation – Mode of operation. WARNING: To prevent electric shock, the instrument must be plugged into an earthed ground outlet. Do not remove or disable the ground pin. Only an authorized Carl Zeiss Meditec service representative may install the instrument.

Visante OCT User Manual

Introduction 1-7 WARNING: Do not use the printer or the instrument or an optional power table with an extension cord or a power strip (multiple portable socket outlet). For additional safety, do not plug the printer and the instrument (or an optional power table) into the same wall outlet. Failure to observe this warning could result in electrical shock to the patient and/or examiner. WARNING: Do not open the instrument covers. (Exception: You may remove the rear cover to access the fuses, labels and connectors.) Opening the instrument covers could expose you to electrical and optical hazards. WARNING: To maintain patient safety, the Visante OCT isolation transformer is required when connecting externally powered peripheral devices (i.e., printer, USB drive, etc.) within 1.5 meters (4.9 feet) from the patient. In addition, the isolation transformer is required for all externally powered peripheral devices outside this distance unless these devices are (1) connected to the Visante OCT using an Unshielded Twisted Pair (UTP) network cable (CZMI recommends using a least a CAT 5 UTP network cable), (2) plugged into a different power outlet than the Visante OCT, and (3) qualified by CZM for use with the Visante OCT. Failure to observe this warning could result in electrical shock to the patient and/or examiner. WARNING: This instrument may cause ignition of flammable gases or vapors. Do NOT use in the presence of flammable anesthetics such as nitrous oxide, or in the presence of pure oxygen. WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped surface. Also, do not roll an optional power table in deep pile carpet or over objects on the floor such as power cords. Failure to observe these precautions could result in tipping of the instrument and/or table and resulting injury to operator or patient and damage to the instrument. Optical Safety This instrument complies with the following standards and regulations: • 21 CFR 1040.10 and 1040.11 • IEC 60825-1 • EN ISO 15004-2 The Visante OCT Visual Aiming Beam is a low-power laser diode device: • 845 nm wavelength with < 5 μW average power at the cornea. • Class 1 Laser Product – Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. • Group 1 Instrument – Per EN ISO 15004-2, Group 1 instruments are ophthalmic instruments for which no potential light hazard exists.

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Introduction The Visante OCT Scanning Beam is a low-power superluminescent diode (SLD) device: • 1310 nm wavelength with < 6.5 mW average power at the cornea. • Group 1 Instrument – Per EN ISO 15004-2, Group 1 instruments are ophthalmic instruments for which no potential light hazard exists.

Electromagnetic Compatibility (EMC) EN 60601-1-2 The Visante OCT needs special precautions regarding EMC and needs to be ☞ Note: installed and put into service according to the EMC information provided herein. Portable and mobile RF communications equipment can affect medical ☞ Note: electrical equipment. WARNING: The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment. WARNING: The Visante OCT should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Guidance and manufacturer’s declaration - electromagnetic emissions The Visante OCT is intended for use in the electromagnetic environment specified below. The customer or user of the Visante OCT should assure that it is used in such an environment Emissions Test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

Visante OCT User Manual

Electromagnetic environment - guidance The Visante OCT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Visante OCT is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Introduction 1-9

Guidance and manufacturer’s declaration - electromagnetic immunity The Visante OCT is intended for use in the electromagnetic environment specified below. The customer or user of the Visante OCT should assure that it is used in such an environment Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

± 2 kV for power supply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines. IEC 61000-4-11

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Visante OCT requires continued operation during power mains interruptions, it is recommended that the Visante OCT be powered from an uninterruptible source.

Note: UT is the a.c. mains voltage prior to application of the test level.

Visante OCT User Manual

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Introduction

Guidance and manufacturer’s declaration - electromagnetic immunity The Visante OCT is intended for use in the electromagnetic environment specified below. The customer or user of the Visante OCT should assure that it is used in such an environment Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Visante OCT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.17 P

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

d = 1.17 P 80 MHz to 800 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

d = 2.33 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Visante OCT is used exceeds the applicable RF compliance level above, the Visante OCT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Visante OCT. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Visante OCT User Manual

Introduction 1-11

Recommended separation distances between portable and mobile RF communications equipment and the Visante OCT The Visante OCT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Visante OCT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Visante OCT as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.17

80 MHz to 800 MHz

P

d = 1.17

P

800 MHz to 2,5 GHz d = 2.33

0,01

0.117

0.117

0.233

0,1

0.370

0.370

0.737

1

1.170

1.170

2.330

10

3.700

3.700

7.368

100

11.700

11.700

23.300

P

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Accessory Equipment WARNING: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

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Introduction Symbols and Labels Caution, consult accompanying documents. Note: There are important operating and maintenance instructions found in the manual.

Presence of electrical shock hazard. Note: Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the instrument. Do not remove the instrument cover or parts.

Fuse

Type B applied parts

Manufacturer

Authorized European Community Representative

Serial number

Catalog number / part number

European Conformity

Visante OCT User Manual

Introduction 1-13 Protective Packing Symbols The protective packing symbols specify the handling requirements and the transport and storage conditions. Handling Requirements Fragile, Handle with Care

Keep Dry

This end up

Transport and Storage Conditions Relative Humidity (10% to 100%, including condensation)

Temperature (-40 to +70 deg. C) Atmospheric Pressure Limits (500 hPa to 1060 hPa)

Product Labels and Serial Number Location Just above the rear cover is the product label:

Figure 1-2 Product Label on Exterior, Rear

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Introduction To gain access to the label showing the serial number, you must remove the rear cover: To remove the rear cover, depress the two snaps at its top edge.

Depress both snaps to remove rear cover.

Figure 1-4 Product Label with Serial Number A second label under the rear cover identifies the authorized EC representative:

Figure 1-3 Removing rear cover

Figure 1-5 Label Identifying EC Representative A small Manufactured month and year label is on the bottom of the instrument:

Figure 1-6 Manufactured Month and Year Label A small laser classification label is on the bottom of the instrument.

Figure 1-7 Class 1 Laser Label A small FDA laser notice label is on the bottom of the instrument.

Figure 1-8 Laser Notice No. 50 Label

Visante OCT User Manual

Introduction 1-15 Rear Connectors Illustrated Under the rear cover, a label illustrates the types of connectors found on the rear of the device, as shown below.

label Mouse Keyboard USB (2)

Serial (2)

Ethernet (network)

Figure 1-9 Rear Connectors and Associated Label

Instrument Disposition When it comes time to upgrade the Visante OCT, please contact Carl Zeiss Meditec to inquire about trade-in or upgrade values we may offer. Should you not wish to trade in the instrument, please see the Disposal section below.

Disposal This product contains electronic components. At the end of its lifetime, the product should be disposed of in accordance with the relevant national regulations. Disposal of the Product within the EU In accordance with applicable EU guidelines at the time at which the product was brought onto the market, the product specified on the consignment note is not to be disposed of via the domestic waste disposal system or communal waste disposal facilities. For further information on disposal of this product, please contact your local dealer or the manufacturer or its legal successor company. Please read the latest internet information provided by the manufacturer. Where the product or its components are resold, the seller must inform the buyer that the product must be disposed of in accordance with the currently applicable national regulations.

Visante OCT User Manual