Heidelberg Engineering SPECTRALIS Bedienungsanleitung
SPECTRALIS®
Ultra-Widefield Imaging
Module
User Manual
Software Version 6.16
June 2020
© Heidelberg Engineering GmbH
Article No. 230134-002 INT.AE20
© Heidelberg Engineering GmbH
Corporate Headquarters and Legal Manufacturer
Heidelberg Engineering GmbH
Max-Jarecki-Str. 8
69115 Heidelberg/Germany
Telephone: +49 (0) 6221 64 63 0
Fax: +49 (0) 6221 64 63 62
Australia
Heidelberg Engineering Pty Ltd
Suite E5, 63 Turner St
Port Melbourne 3270
Victoria
Telephone: +61 396 392 125
Fax: +61 396 392 127
UK
Heidelberg Engineering Ltd.
55 Marlowes
Hemel Hempstead
Hertfordshire HP1 1LE
Telephone: +44 (0) 1442 502 330
Fax: +44 (0) 1442 242 386
Switzerland
Heidelberg Engineering GmbH
Schulstrasse 161
8105 Regensdorf
Telephone: +41 (0) 44 8887 020
Fax: +41 (0) 44 8887 024
Email: [email protected]
Internet: http://www.HeidelbergEngineering.com
Please read this document and follow all operating instructions
before using the medical device.
Medical device
Heidelberg Engineering hereby declares that this product conforms
to the requirements of Directive 93/42/EEC of the Council of the
European Community dated 14 June 1993 regarding medical
products (MDD 93/42/EEC).
If the device is modified by someone other than authorized service
personnel, or if the software is not installed and configured as
specified, the warranty will become void. Heidelberg Engineering
does not take responsibility for modified devices.
Please note that images shown in this document may vary slightly
from the actual product.
This document describes or references hardware components
and/or software components that may not be part of your system
configuration. Accessories and software modules may need to be
purchased separately even if they are not explicitly marked as
optional in this document. Some features may not be available in
your country currently.
SPECTRALIS® is a registered trademark of
Heidelberg Engineering Inc. in the United States and/or other
countries.
Microsoft® and Windows® are either registered trademarks or
trademarks of Microsoft Corporation in the United States and/or
other countries.
ThunderboltTM is a trademark of Intel Corporation in the United
States and/or other countries.
Warranty
Supplemental instructions
© Heidelberg Engineering GmbH, Article No. 230134-002 INT 3
Table of Contents
1 Preface................................................................................. 5
1.1 Symbols Used in this Document................................... 5
1.2 Intended Use................................................................ 7
1.3 Compatibility................................................................. 7
2 Terms and Definitions........................................................ 9
3 General Safety Messages................................................. 11
3.1 Patient Safety.............................................................. 11
3.2 Data Security.............................................................. 13
4 Exchanging Objective Lenses......................................... 14
5 Acquiring Images.............................................................. 16
5.1 Preparations............................................................... 16
5.1.1 Available Acquisition Modes.................................... 16
5.1.2 Setting Acquisition Parameters................................ 18
5.2 Examining Patients with Deep-seated Eyes or Small
Orbits.......................................................................... 19
5.3 Acquiring Images........................................................ 20
5.3.1 Starting New Examinations...................................... 20
5.3.2 Aligning the cSLO Image......................................... 22
5.3.3 Acquiring cSLO Images........................................... 23
5.3.4 Acquiring Simultaneous IR and BAF Images........... 25
5.3.5 Performing Angiographies....................................... 27
6 Viewing Images................................................................. 31
7 Troubleshooting................................................................ 32
7.1 Artifacts....................................................................... 32
7.1.1 Artifacts in Cross-Polarized Images......................... 32
8 Index................................................................................... 33
Table of Contents
© Heidelberg Engineering GmbH, Article No. 230134-002 INT
4
1 Preface
This user manual serves as a reference guide for optional
accessory modules from Heidelberg Engineering. Read the entire
user manual to gain a full understanding of the software and/or the
hardware components. It is not necessary to read all the chapters
in chronological order. Begin with a topic of interest. Follow the
links and references included in the text for guidance to other
chapters.
If you have any further questions on the SPECTRALIS software,
hardware specifications, or HEYEX please refer to the following
applicable documents (° “Applicable documents”, p. 5):
Applicable documents
Article No. Revision Document Content
230131 006 et seq. SPECTRALIS Product Family
User Manual
In this document, you will find all information
on how to operate your SPECTRALIS device
safely.
230006 010 et seq. SPECTRALIS Hardware
Manual
In this document, you will find all information
on the hardware and software, setting up the
device, electrical safety, cleaning and
disinfection, disposing of the device, and
technical specifications.
230088 003 et seq. HEYEX User Manual In this document, you will find all information
on HEYEX.
Please have this document on hand if you are
working with HEYEX version 1.10.
230111 006 et seq. HEYEX 2 User Manual In this document, you will find all information
on HEYEX 2.
Please have this document on hand if you are
working with HEYEX 2 version 2.5.1 or higher.
230005 005 et seq. SPECTRALIS Accessories
Hardware Manual
In this document, you will find all information
on hardware for the Anterior Segment Module,
the Widefield Imaging Module, the High
Magnification Module and the Ultra-Widefield
Imaging Module.
1.1 Symbols Used in this Document
This chapter describes the definitions, formatting, and symbols
used in this document.
Keys are identified by their symbol, for example + .
The code of, for example, the heyex.ini file is identified by
monospaced typeface, for example DefaultDevice=1.
Elements of the graphical user interface such as buttons, window
names, or file names are identified by quoted “italic” font, for
example “Next” .
Keys
Code
Elements of the graphical user
interface
Preface
Symbols Used in this Document
1
© Heidelberg Engineering GmbH, Article No. 230134-002 INT 5
Menu paths in the software are identified by quoted “italic” font.
Each menu item is separated by a black triangle u, for example
“File ► Save as”.
Information available on websites is identified by underlined text,
for example http://www.heidelbergengineering.com. Click on the
URL to open the corresponding website.
Cross-references are identified by parentheses and a black arrow
(°), for example: (° “Cross-references”, p. 6).
Safety messages are indicated by symbols in this document. They
are marked by a signal word and a safety alert symbol indicating
the category of the hazard.
Safety messages answer the following questions:
▪What is the hazard?
▪What are possible consequences of not avoiding the hazard?
▪How should the hazard be avoided?
WARNING!
Warning indicates a hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION!
Caution with the safety alert symbol indicates a
hazardous situation which, if not avoided, could
result in minor or moderate injury.
NOTICE!
Notice is used to address practices not related to
personal injury.
Safety messages can also be integrated into the step of a
procedure if they apply to that specific step only.
Example:
This is step 1.
L CAUTION! This is an embedded safety message of the type
"Caution".
This is step 2.
Notes provide important information or tips.
Menu paths
URL
Cross-references
Safety messages
Notes
Preface
Symbols Used in this Document
1
© Heidelberg Engineering GmbH, Article No. 230134-002 INT
6
Examples are identified by a gray background over the entire
width of the page.
Examples
Procedures are used for supporting the reader in completing a task
and are marked by red triangles:
Step 1.
Step 2.
Lists are used for structuring information and are marked by red
squares:
▪List entry
▪List entry
1.2 Intended Use
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging
device. It is intended for:
▪viewing the posterior segment of the eye, including two- and three-
dimensional imaging
▪cross-sectional imaging (SPECTRALIS HRA+OCT and
SPECTRALIS OCT)
▪fundus imaging
▪fluorescence imaging (fluorescein angiography, indocyanine green
angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
▪autofluorescence imaging (SPECTRALIS HRA+OCT,
SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
▪performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management
of various ocular diseases, including:
▪age-related macular degeneration
▪macular edema
▪diabetic retinopathy
▪retinal and choroidal vascular diseases
▪glaucoma
The device is indicated for viewing geographic atrophy as well as
changes in the eye that result from neurodegenerative diseases.
The SPECTRALIS OCT Angiography Module is indicated as an aid
in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include
reference databases for measurements of retinal layer and optic
nerve head anatomy, which are used to quantitatively compare
measurements in the human retina and optic nerve head to values
found in normal subjects.
1.3 Compatibility
The following software versions are required to run the Ultra-
Widefield Imaging Module with all of the features described in this
manual:
▪Heidelberg Eye Explorer (HEYEX) software version 1.10
▪Heidelberg Eye Explorer (HEYEX 2) software version 2.5.1 or
higher
Procedures
Lists
Preface
Compatibility
1
© Heidelberg Engineering GmbH, Article No. 230134-002 INT 7
▪SPECTRALIS Acquisition Module (AQM) software version 6.16 or
higher
▪SPECTRALIS Viewing Module (VWM) software version 6.16 or
higher
Preface
Compatibility
1
© Heidelberg Engineering GmbH, Article No. 230134-002 INT
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2 Terms and Definitions
Acquisition module
Automatic Real Time Mean
With ART Mean, mean images are created automatically. These
mean images enhance image quality as a result of noise reduction.
For performance reasons, this process has a tolerance, so the
actual number of frames used to create the mean image may differ
by a few scans from the configured value. However, the
improvement of the signal-to-noise ratio never varies more than
±10 %. The effect on the q-value is ±0.5 or less.
To check the number of images averaged, select
“Image ► Image Information” from the menu bar of the analysis
window. In the “OCT Image” section, the number of images
averaged is given in the “ART Mode” entry.
BluePeak Blue Laser Autofluorescence
Cross-polarized images can be acquired while the filter wheel is
pointed at “P” . Cross-polarized images will be darker than normal
reflectance images and may contain polarization effects. This
image contrast effect is caused by birefringent properties of the
examined structure.
Corneal Curvature
confocal Scanning Laser Ophthalmoscopy
Data interchange format of the Heidelberg Eye Explorer
Fluorescein Angiography
Heidelberg Eye Explorer
Heidelberg Eye Explorer 2
HEYEX 2 is the next generation Heidelberg Eye Explorer platform
which provides centralized management of image data in
ophthalmology.
High resolution
If you select HR as the scan resolution mode in the acquisition
module, images are acquired with a higher spatial scan resolution,
but with a low scan rate. HR acquires more data points over a
longer time period and requires more time and space for data
storage.
Heidelberg Retina Angiograph
AQM
ART Mean
BAF
Cross-polarized mode
C-Curve
cSLO
E2E
FA
HEYEX
HEYEX 2
HR
HRA
Terms and Definitions 2
© Heidelberg Engineering GmbH, Article No. 230134-002 INT 9
High speed
If you select HS as the scan resolution mode, images are acquired
at a faster rate but will be of a lower scan resolution. HS is
optimized for fast image acquisition with a high frame rate and
reduced data storage.
Heidelberg Retina Angiograph
Indocyanine Green Angiography
Infrared reflectance
Optical coherence tomography
Oculus dexter; right eye
Oculus sinister; left eye
Viewing module; also referred to as analysis window
Cross-polarized infrared reflectance
For further information, please refer to (° “Cross-polarized
mode”, p. 9).
HS
HRA
ICGA
IR
OCT
OD
OS
VWM
XP-IR
Terms and Definitions2
© Heidelberg Engineering GmbH, Article No. 230134-002 INT
10
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