Cirrus HD-OCT Model 4000 User Manual Rev B

Contents iii Contents

DRAFT/PRE-RELEASE/CONFIDENTIAL

(1) Introduction... 1-1 Intended Use... 1-1 Indications for Use... 1-1 Purpose of This User Manual... 1-2 Cirrus HD-OCT Technology... 1-3 Cirrus HD-OCT System Hardware... 1-4 WARNING: User Changes to Software or Hardware... 1-5 Instrument Installation... 1-5 Tips to Avoid Damage... 1-6 Embedded Windows License... 1-6 Product Compliance... 1-7 Product Safety... 1-7 Electromagnetic Compatibility (EMC)... 1-9 Accessory Equipment... 1-13 Symbols and Labels... 1-14 Rear Connectors Illustrated... 1-17 Instrument Disposition... 1-18

(2) Operational Overview... 2-1 Chapter Overview... 2-1 System Start and Login... 2-1 Initial System Setup...2-4 Operational Modes and Screens... 2-7 Common Screen Elements...2-8 Performance Verification Check... 2-15 Power Down the System... 2-21

(3) Acquire Scans... 3-1 Chapter Overview... 3-1 Prepare the Patient... 3-1 Identify a Patient...3-2 Select Scan Type...3-5 Acquire Scan...3-8 Review Screen... 3-16

(4) Analyze Scans: Macula... 4-1 Chapter Overview... 4-1 Access Analysis... 4-1 Macular Thickness Analysis...4-3 Macular Change Analysis... 4-14 Macular Change Analysis–Manual Selection... 4-19

Cirrus HD-OCT User Manual

PN 2660021133273 B

iv

Contents Advanced Visualization...4-20 High Definition Image Analysis – 5 Line Raster...4-29 Reports and Printing...4-30

DRAFT/PRE-RELEASE/CONFIDENTIAL

(5) Analyze Scans: RNFL and Optic Nerve5-1 Chapter Overview... 5-1 Access Analysis... 5-1 RNFL Thickness Analysis...5-2 Advanced Visualization Analysis... 5-7 Guided Progression Analysis...5-8 Performance of Cirrus HD-OCT RNFL Analysis... 5-21

(6) Data Management... 6-1 Chapter Overview... 6-1 The admin User... 6-1 Create Institution Name and Logo...6-2 Equipment Edit: Create a Station Name...6-3 Staff Registration...6-4 Record Search...6-6 Create, Edit and Delete Patient Records...6-9 Merge Patient Records... 6-12 Categorize Patient Records... 6-15

(7) Archive and Retrieve... 7-1 Chapter Overview... 7-1 The Patient Database... 7-1 Data Maintenance Requirements... 7-2 Clear Exam Data... 7-2 Archive Recommendations... 7-4 Archive Management... 7-6 Manual Archive... 7-9 Retrieve Exam Data... 7-10

(8) Export and Import... 8-1 Chapter Overview... 8-1 Privacy and Data Integrity Features... 8-1 Export Data...8-2 Export to Optical Media...8-8 Import Data... 8-11

(9) Routine Maintenance... 9-1 Chapter Overview... 9-1 Fuse Replacement... 9-1

Cirrus HD-OCT User Manual

PN 2660021133273 B

Contents v Handling Error Messages...9-5 Hard Disk Defragmentation...9-6 Routine Cleaning...9-6 List of User Replacement Accessories...9-8

DRAFT/PRE-RELEASE/CONFIDENTIAL

(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) Networking Guidelines... A-1 Notice... A-1 Network Capabilities... A-1 WARNING: Risks of Internet Connectivity... A-1 Prohibited Activities...A-2 Network Activities Not Supported...A-2 Network File Server Minimum Requirements...A-2 Network File Server Recommendations...A-3 Using the Network File Server...A-3 Configuration for Direct Export to a Personal Computer...A-6

(B) Using a Network Storage Device... B-1 Introduction... B-1 NAS Device Safety Warnings... B-1 NAS Device Requirements...B-2 NAS Device Recommendations...B-2 Install and Configure the NAS Device...B-2 Cleaning the NAS Device...B-6

(C) Printer Configuration... C-1 Introduction... C-1 Approved Printers... C-1 Printer Safety Warnings...C-2 Installation Overview...C-2 Network Configuration...C-3 USB Configuration...C-3

(D) RNFL and Macula Normative Databases... D-1 Introduction...D-1 Inclusion and Exclusion Criteria...D-1 Data Collection... D-2 Cirrus RNFL and Macula Normative Database Development... D-3

Cirrus HD-OCT User Manual

PN 2660021133273 B

vi ... D-9 Conclusion... D-9

DRAFT/PRE-RELEASE/CONFIDENTIAL DRAFT/PRE-RELEASE/CONFIDENTIAL

(E) Study: Retinal Segmentation Algorithms in Cirrus HD-OCT... E-1 Introduction... E-1 Purpose... E-1 Methods... E-1 Results and Discussion...E-2 Conclusion...E-9

Index... I-1

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction 1-1

The ZEISS Cirrus™ HD-OCT Model 4000 (Cirrus HD-OCT or Cirrus) enables examination of the posterior and anterior of the eye at an extremely fine spatial scale, without surgical biopsy or even any contact with the eye. The Cirrus HD-OCT builds on and refines the retinal imaging technology first introduced with the ZEISS Stratus OCT™. HD-OCT stands for “high-definition optical coherence tomography.”

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

(1) Introduction

Employing the advanced imaging technology of spectral domain optical coherence tomography, Cirrus HD-OCT acquires OCT data about 70 times faster (27,000 vs. 400 A-scans per second) and with better resolution (5 μm vs. ~10 μm axial resolution in tissue), compared to first-generation OCT technology. Cirrus acquires whole cubes of OCT image data, composed of hundreds of line scans, in about the same time as Stratus acquires a six-line scan. You can view these data cubes in three planes, or through three dimensions, giving you access to an extensive amount of retinal image data in one scan.

Intended Use The Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

Indications for Use The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula, and optic disc. The Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL) and Macular Normative Databases is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma. The Cirrus HD-OCT is not intended to be used as the sole diagnostic ☞ Note: for disease.

Cirrus HD-OCT User Manual

PN 2660021133273 B

1-2

Introduction

Carl Zeiss Meditec designed this User Manual to serve as a training, usage and reference guide for proper scanning and operation. 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 Cirrus HD-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

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Purpose of This User Manual

This introductory chapter provides a system description, installation and safety information. Chapters (2) through (4) are organized according to the normal sequence of operation of the Cirrus HD-OCT, followed by data management and data transfer functions in Chapters (6) through (8), as follows: • Operational Overview, explained in Chapter (2). • Acquire Scans, explained in Chapter (3). • Analyze Scans: Macula, explained in Chapter (4). • Data Management, explained in Chapter (6). • Archive and Retrieve, explained in Chapter (7). • Export and Import, explained in Chapter (8). Chapters (9), (10) and (11) cover Routine Maintenance, instrument Specifications and Legal Notices, respectively. Users who wish to use the Cirrus HD-OCT in a network environment should see Appendix (A) Networking Guidelines and Appendix (B) Using a Network Storage Device. Appendix (C) Printer Configuration provides instructions to use a printer in the USB or network configuration. 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.

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction 1-3 Electronic User Manual Access

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

The Cirrus HD-OCT User Manual is provided with the instrument electronically in three ways: 1. On-Line Manual: Select On-Line Manual from the Help (click Help > On-Line Manual) menu to access the user manual information through the Cirrus software. 2. On CD: Included in the instrument accessory kit. You can view the user manual PDF either using the Cirrus system computer, or any other computer. 3. On the computer desktop: To access the computer desktop without exiting the system software: A. Press Ctrl+Esc on the keyboard. Select My Computer. B. Open the pull down menu and scroll up to highlight Desktop. C. Double-click on the folder User Manuals. D. Double-click on the Cirrus HD-OCT User Manual. Once opened, you can switch between the user manual and the Cirrus ☞ Note: application by pressing Alt+Tab.

Cirrus HD-OCT Technology The Cirrus HD-OCT is a computerized instrument that acquires and analyzes cross-sectional and three-dimensional tomograms of the eye using spectral domain optical coherence tomography (SD-OCT). SD-OCT is a form of non-invasive, low-coherence interferometry that produces high-resolution tomograms 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 an 840 nm superluminescent light emitting diode (SLD). Light returning from the sample and reference paths is combined at the detector, which is a spectrometer in SD-OCT. The spectrometer resolves the interference signals throughout the depth of each A-scan immediately by means of a Fourier transformation. This is possible because the spectrometer resolves the relative amplitudes and phases of the spectral components scattered back from all depths of each A-scan tissue sample, without varying the length of the reference path. Eliminating the necessity of moving a mechanical reference arm makes it possible to acquire OCT image data about 70 times faster than conventional (time domain) OCT. The vast increase in scan speed makes it possible for Cirrus HD-OCT to acquire three-dimensional data sets, or entire cubes of data in about the same time (depending on the selected scan type) as conventional OCT. In spite of the increased speed of scanning, spectral detection of the interference signal provides superior resolution. Tomograms are stored on the computer and/or on an archive medium, and can be quantitatively analyzed. Besides the HD-OCT imaging system, Cirrus employs two additional live imaging systems simultaneously to facilitate ease of use: a CCD video camera monitors the exterior eye and assists with scan alignment, while a line scanning ophthalmoscope (LSO) provides a clear image of the retinal area addressed by the scan.

Cirrus HD-OCT User Manual

PN 2660021133273 B

1-4

Introduction

With the exception of the keyboard, mouse and printer, the Cirrus HD-OCT integrates all hardware components in a unit, which includes the scan acquisition optics, the interferometer and spectrometer, the system computer and video monitor. Carl Zeiss Meditec offers an optional wheelchair accessible motorized power table (shown below), which accommodates elevation adjustment to each patient's height. The illustration below labels hardware elements. System specifications are in Chapter (10). Port for External Fixation Arm Head Rest Integrated Video Monitor

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

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Cirrus HD-OCT System Hardware

Imaging Aperture

Dual Chin Rest with Automatic Right/Left Sensors CD drive and USB port 3-D Motorized Patient Alignment Unit

Table Height Controls

(Optional) Power Table

System Power Switch

Keyboard

Mouse

Figure 1-1 Cirrus HD-OCT system hardware Software Carl Zeiss Meditec pre-installs all software necessary to operate the Cirrus HD-OCT. Software updates with installation instructions may be provided on CD or on our website. Data Storage The system computer stores data locally. Archival storage of Cirrus HD-OCT exam data is designed to occur in a network environment. We recommend archiving data to a network file server or a 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 and Retrieve, (A) Networking Guidelines, and (B) Using a Network Storage Device.

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction 1-5

The Cirrus HD-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 Cirrus HD-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. Unauthorized modification also voids the instrument warranty. Approved Software

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

WARNING: User Changes to Software or Hardware

Please refer to the Cirrus HD-OCT Technical Support section of our website (www.meditec.zeiss.com/cirrus) for the current list of approved software. Carl Zeiss Meditec does not provide technical support for the use of third party ☞ Note: software.

Instrument Installation Only an authorized Carl Zeiss Meditec service representative should install the Cirrus HD-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. Only trained CZM personnel may perform calibration. The Performance ☞ Note: Verification Check (see page 2-15) is not calibration. Care in Handling Use extreme care when handling and transporting the Cirrus HD-OCT shipping boxes. The instrument contains fragile optics that require highly precise alignment. Installation Requirements • The instrument with the optional power table requires an area at least 6' x 8' (1.80 m by 2.4 m) for installation and patient comfort during use. • You must install it in a ventilated room and must not block the ventilated instrument covers that allow heat to dissipate from the device. For more information on acceptable operating conditions, see the specifications for Environmental Conditions on page 10-2. WARNING: Failure to provide proper ventilation could potentially lead to heat buildup, which could cause component failure and/or fire. • The Cirrus HD-OCT should operate on a dedicated power outlet. Based on your specification, we configure your Cirrus HD-OCT at the factory to use either 100/120V or 220/240V line voltage.

Cirrus HD-OCT User Manual

PN 2660021133273 B

1-6

Introduction • When using the optional power table, the instrument must be powered through the table-see Power the Instrument Through the Table on page 1-19.

Users are not authorized to dismantle (except to remove the rear cover) or ☞ Note: modify the Cirrus HD-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 Cirrus HD-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.

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Tips to Avoid Damage

• 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, and do not use aerosols on or near it. • The optional power table has an IP21 classification, which provides the specified degree of protection against harmful ingress of water. Still, do not place containers of liquid on or near the table where spillage onto the instrument or table could occur, resulting in a safety hazard and/or damage to the instrument or the table. • In case of a non-medical emergency related to the instrument, unplug the power cord from the wall outlet and call for service immediately. • To prevent heat buildup that could damage the instrument, you must install it in a ventilated room and must not block the ventilated instrument covers that allow heat to dissipate from the device. For more information on acceptable operating conditions, see the specifications for Environmental Conditions on page 10-2. • 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 Cirrus HD-OCT instrument is issued with an embedded Windows license located under the rear cover.

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction 1-7 Product Compliance

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:

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Complies with 93/42/EEC Medical Device Directive.

• 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 earth grounded outlet. Do not remove or disable the ground pin. Only an authorized Carl Zeiss Meditec service representative may install the instrument. WARNING: Do not use the printer or the instrument or the 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 the 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, peripheral devices, such as printers, must be placed at least 1.5 meters (4.9 feet) away from the patient, such that the patient cannot touch a peripheral device with any part of his or her body while being examined. In addition, the instrument operator must not attempt to touch the patient and a peripheral device at the same time while examining the patient. The optional Cirrus HD-OCT Power Table is safe to use within the patient ☞ Note: environment when the instrument is powered through it, as instructed herein.

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction WARNING: Do not reconfigure system components on the table, nor add non-system devices or components to the table, nor replace original system components with substitutes not approved by Carl Zeiss Meditec. Such actions could result in failure of the table height adjustment mechanism, instability of the table, tipping and damage to the instrument, and injury to operator and patient. 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.

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

1-8

WARNING: Avoid tipping. Do not use the instrument on an uneven or sloped surface. Also, do not roll the 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. WARNING: When you complete scan acquisition and before you click the Finish or ID Patient buttons in the Acquire Screen, always prompt the patient to sit back and move the head away from the chinrest. Clicking either of these buttons in the Acquire Screen causes the chinrest to reposition itself beyond the point where the patient’s eye would contact the lens if the head remained in the chinrest. Failure to observe this warning could result in injury to the patient. WARNING: The operator should check that the patient is not holding on to the instrument before or during tests. Although movement of the motorized chinrest is slow, giving plenty of warning for patients to remove their fingers, there is potential for fingers to be squeezed and possibly injured. WARNING: Do not scan patients who have been injected with photo-dynamic therapy (PDT) treatment drugs, such as Visudyne®, in the previous 48 hours. Failure to observe this warning could result in unintended exposure and uncontrolled treatment of neovascular vessels. Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner. WARNING: This device contains visual stimuli, including flickering light and flashing patterns, between 5 and 65 Hz. Medical professionals need to determine whether this device should be used for patients who may be photosensitive, including those with epilepsy.

Cirrus HD-OCT User Manual

PN 2660021133273 B

Applicable Phototoxicity Statements (FDA CDRH Ophthalmoscope Guidance #71): Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged. While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the exposure time for the patient’s eye be limited to the minimum time that is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. Note: This medical device has no user adjustable intensity settings for light incident on the retina, nor does it produce UV radiation or short-wavelength blue light.

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Introduction 1-9

Electromagnetic Compatibility (EMC) EN 60601-1-2:2001 compliant The Cirrus HD-OCT has special EMC precaution requirements 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 Cirrus HD-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.

Cirrus HD-OCT User Manual

PN 2660021133273 B

1-10

Introduction

Guidance and manufacturer’s declaration - electromagnetic emissions

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

The Cirrus HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the Cirrus HD-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 A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

Cirrus HD-OCT User Manual

Electromagnetic environment - guidance The Cirrus HD-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 Cirrus HD-OCT is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

PN 2660021133273 B

Introduction 1-11

Guidance and manufacturer’s declaration - electromagnetic immunity

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

The Cirrus HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the Cirrus HD-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 Cirrus HD-OCT requires continued operation during power mains interruptions, it is recommended that the Cirrus HD-OCT be powered from an uninterruptible source.

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

Cirrus HD-OCT User Manual

PN 2660021133273 B

1-12

Introduction

Guidance and manufacturer’s declaration - electromagnetic immunity

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 Cirrus HD-OCT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

The Cirrus HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the Cirrus HD-OCT should assure that it is used in such an environment

Recommended separation distance 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 Cirrus HD-OCT is used exceeds the applicable RF compliance level above, the Cirrus HD-OCT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Cirrus HD-OCT. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction 1-13

The Cirrus HD-OCT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cirrus HD-OCT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cirrus HD-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

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Recommended separation distances between portable and mobile RF communications equipment and the Cirrus HD-OCT

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.

Cirrus HD-OCT User Manual

PN 2660021133273 B

1-14

Introduction

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.

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

Symbols and Labels

Fuse

Type B applied parts

Manufacturer

Authorized European Community Representative

Serial number

Catalog number / part number

Model number

European Conformity

Cirrus HD-OCT User Manual

PN 2660021133273 B

Introduction 1-15 Protective Packing Symbols

Handling Requirements Fragile, Handle with Care

Keep Dry

5/15/09

DRAFT/PRE-RELEASE/CONFIDENTIAL

The protective packing symbols specify the handling requirements and the transport and storage conditions.

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)

☞ Note: The instrument is not intended to be transported outside its original package.

Cirrus HD-OCT User Manual

PN 2660021133273 B