Heidelberg Engineering SPECTRALIS User Manual Download Page 7

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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

Summary of Contents for SPECTRALIS

Page 1: ...SPECTRALIS Ultra Widefield Imaging Module User Manual Software Version 6 16 June 2020 Heidelberg Engineering GmbH Article No 230134 002 INT AE20...

Page 2: ...y 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...

Page 3: ...t 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 softw...

Page 4: ...odes 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...

Page 5: ...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 2...

Page 6: ...d 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 injur...

Page 7: ...tection 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...

Page 8: ...CTRALIS 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 I...

Page 9: ...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 structur...

Page 10: ...idelberg 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...

Page 11: ...ive lens in front of the patient Dirty device parts can transmit pathogenic germs causing infections CAUTION Artifacts due to reflections from internal optics can be visible in reflectance images Resi...

Page 12: ...consider performing additional examinations possibly with other diagnostic devices to obtain a good clinical judgment WARNING If the patient is not correctly positioned in front of the device poor im...

Page 13: ...xamined Ensure that enough memory is available on the disk where the patient data are saved Archive data regularly CAUTION A hardware or software failure during image acquisition may cause the softwar...

Page 14: ...ve lens and the red dot on the lens mount at the 12 o clock position The Ultra Widefield objective lens weighs about 1 kilogram The Ultra Widefield objective lens is larger and heavier than the SPECTR...

Page 15: ...tive lens The focus range for a properly focused image acquired with the Ultra Widefield objective lens is significantly larger than with the SPECTRALIS standard objective lens Therefore the displayed...

Page 16: ...SPECTRALIS standard objective lens Therefore the displayed Focus value in the Settings section is not reliable and may vary significantly from the patient s actual refraction Please note that only the...

Page 17: ...ssible Please check the filter wheel position and the mounted objective Turn the filter wheel to the filter wheel position A or P accordingly Please note that you cannot acquire OCT images with the Ul...

Page 18: ...will receive a message in the acquisition window indicating that acquisitions are currently not possible Please select either a different acquisition mode or turn the filter wheel to the filter wheel...

Page 19: ...elect To switch on the external fixation light press External All squares are now red and the external fixation light is switched on To return to the main menu press 5 2 Examining Patients with Deep s...

Page 20: ...dy been created within HEYEX Start the HEYEX software Switch on the device Prepare the device Prepare the patient From the patient list select the desired patient and select from the tool bar of the d...

Page 21: ...ndow p 21 Select to open the Start examination window The Start examination window shows all orders that have been placed for your modality Select the desired order and click Start examination to star...

Page 22: ...age is sharply displayed If the cSLO image has dark edges move the camera closer to the patient s eye Fig 3 If the cSLO image is too dark in the upper part turn the joystick counterclockwise to move t...

Page 23: ...er layer Start a new examination 5 3 1 Starting New Examinations p 20 Set the acquisition parameters 5 1 2 Setting Acquisition Parameters p 18 Turn the filter wheel to the filter wheel position P 5 1...

Page 24: ...images without ART Mean Watch the small live image for an even illumination Keep your hands on the device and readjust the camera as needed When the adjusted number of frames is reached either press A...

Page 25: ...1 Available Acquisition Modes p 16 Select XP IR as the acquisition mode 5 1 1 Available Acquisition Modes p 16 To examine the right eye move the camera to the left and to examine the left eye move th...

Page 26: ...ire images without ART Mean Watch the small live images for an even illumination Keep your hands on the device and readjust the camera as needed Press either Acquire on the touch panel or press the bu...

Page 27: ...s which may result in incorrect therapeutic approaches Follow the instructions given on the contrast agent package insert WARNING Allergic reactions may occur due to unidentified allergies or intolera...

Page 28: ...ed and the injection timer Inj is activated the indocyanine green angiography starts In the acquisition window ICGA and ICG Angiography are displayed On the touch panel press Inj and inject the dye im...

Page 29: ...ean activated To acquire images with ART Mean press on the touch panel ART Mean is activated The small live images are displayed The gray progression bar increases as the ART Mean counts to 100 frames...

Page 30: ...turns to To quit the examination and close the acquisition window click or press on the keyboard The acquired images and movies are saved The acquisition window closes The acquired images are displaye...

Page 31: ...lays please refer to the SPECTRALIS Product Family User Manual Fig 7 Analysis window For images acquired with the SPECTRALIS Ultra Widefield Module all viewing functions are available that are also of...

Page 32: ...A bow tie pattern within the macula due to the Henle fibers Inhomogeneous appearance of the birefringent retinal nerve fiber layer Furthermore less reflected light will be detected in cross polarized...

Page 33: ...l fixation light 18 F FA angiography 28 FA ICGA angiography 28 FA IR angiography 28 filter wheel position A 18 position P 18 position R 18 filter wheel position selecting 16 fixation light external 18...

Page 34: ...S scan resolution High resolution 18 High speed 18 selecting acquisition mode 16 filter wheel position 16 starting angiography 28 U Ultra Widefield objective lens objective lense 14 UWF acquisition mo...

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