Heidelberg HRA 2 User manual
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Heidelberg Retina Angiograph 2
HRA 2
Operation Manual
Revision 1.1-1E, March 2003
©Heidelberg Engineering GmbH
Printed in Germany
Technical Specifications are Subject to change without notice
Art.No. 97 039-002
The manufacturer 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).
This product is manufactured under one or more of the following patents:
US 5,170,276; DE 41 03 298 C2; EP 0 498 280 B1.
Heidelberg Engineering GmbH
Gerhart-Hauptmann-Strasse 30
69221 Dossenheim
Tel 06221 / 64 63 - 0
Fax 06221 / 64 63 62
Internet: http://www.HeidelbergEngineering.de
Internet: http://www.HeidelbergEngineering.com
In the United States of America:
Heidelberg Engineering, Inc. Heidelberg Engineering, Inc.
Sales and Marketing Technical Support
1499 Poinsetta Avenue, Suite 160 410 Harris Road
Vista, CA, 92083 Smithfield, RI 02917-1301
Tel (760) 598 3770 (800) 931-2230 Tel (401) 349-0500
Fax (760) 598 3060 Fax (401) 349-0504
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Heidelberg Retina Angiograph 2
HRA 2
Operation Manual
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Contents
1 Introduction....................................................................................................................................3
1.1 Intended use............................................................................................................................3
1.2 The Heidelberg Retina Angiograph 2...................................................................................3
2 Contraindications, Warnings, Precautions and Adverse Events.................................................4
2.1 Contraindications....................................................................................................................4
2.2 Warnings.................................................................................................................................4
2.3 Precautions.............................................................................................................................. 5
3 Installation and Safety Information ..............................................................................................6
3.1 Components of the Instrument ..............................................................................................6
3.2 Scope of delivery....................................................................................................................7
3.3 Installing the Instrument ........................................................................................................8
3.4 Instrument Safety ...................................................................................................................9
3.4.1 General Information........................................................................................................9
3.4.2 Laser Safety.....................................................................................................................9
3.5 Care .......................................................................................................................................10
4 General Operating Information...................................................................................................11
4.1 Turning the Instrument On and Off.....................................................................................11
4.1.1 Turning On....................................................................................................................11
4.1.2 Turning Off ...................................................................................................................11
4.2 Controls.................................................................................................................................11
4.2.1 Touch Panel...................................................................................................................11
4.2.2 Foot switch....................................................................................................................23
4.2.3 Keyboard.......................................................................................................................23
4.2.4 Mouse ............................................................................................................................23
4.2.5 Focus knob ....................................................................................................................23
4.2.6 Filter Lever....................................................................................................................23
4.2.7 Sensitivity Knob............................................................................................................24
5 Image Acquisition........................................................................................................................25
5.1 Preparation............................................................................................................................25
5.1.1 Preparing the Patient.....................................................................................................25
5.1.2 Preparing the Instrument..............................................................................................25
5.2 Image Acquisition................................................................................................................25
5.2.1 Creating a new patient record ......................................................................................25
5.2.2 Creating a new examination.........................................................................................26
5.2.3 Touch Panel Settings and Patient Alignment..............................................................27
5.2.4 Displaying and Changing Acquisition Parameters.....................................................28
5.2.5 Acquiring Images..........................................................................................................29
5.3 Image Acquisition Setup......................................................................................................31
5.3.1 Scan Parameter Setup...................................................................................................31
5.3.2 Resetting the injection timers.......................................................................................31
6 Image Inspection and Analysis ...................................................................................................32
6.1 Image Viewing .....................................................................................................................32
6.1.1 Image Display...............................................................................................................32
6.1.2 Image Enhancement......................................................................................................33
6.1.3 Movie Display...............................................................................................................34
6.1.4 Expanding a Movie.......................................................................................................35
6.2 Image Processing..................................................................................................................36
6.2.1 Computing Composite Images.....................................................................................36
6.2.2 Computing Mean Images .............................................................................................37
6.2.3 Eye Movement Correction ...........................................................................................38
6.3 Printing..................................................................................................................................38
7 Technical Data .............................................................................................................................40
7.1 Model Type and Manufacturer............................................................................................40
7.2 Environmental Specifications..............................................................................................40
7.3 Power Supply and fuses.......................................................................................................40
7.4 Isolation Transformer for PC- components........................................................................41
7.5 Laser Source .........................................................................................................................41
7.6 Scanning Specifications.......................................................................................................42
7.7 PC Requirements..................................................................................................................43
7.8 Service, Maintenance and Cleaning....................................................................................43
7.9 Labels....................................................................................................................................44
7.10
Disposal.............................................................................................................................46
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1 Introduction
1.1 Intended use
The Heidelberg Retina Angiograph 2 is a diagnostic device for the human eye.
Intended use is for the examination of the retina by laser scanning either with or without contrast
agent, resp. fluorescence agent). The purpose of the angiography testing is to assist in the diagnosis of eye diseases. The diagnostic result shall provide help to the physician for adequate therapy.
1.2 The Heidelberg Retina Angiograph 2
The Heidelberg Retina Angiograph 2 is a confocal laser scanning system for digital fluorescein
and indocyanine green angiography. Fluorescein and indocyanine green angiography can be performed either separately or simultaneously.
For acquisition of the digital confocal images, a laser beam with a wavelength suitable to excite
the fluorescent dye is focused on the retina. The laser
beam is deflected periodically by means of oscillating
mirrors to sequentially scan a two-dimensional section of the retina. The intensity of the emitted fluorescent light at each point is measured with a light
sensitive detector. In a confocal optical system, light
emitted outside of the adjusted focal plane is suppressed. This suppression increases with the distance
from the focal plane, and results in a high contrast
image. Furthermore (especially during indocyanine
green angiography), the confocal optical system allows the user to acquire three-dimensional images
layer by layer, which is comparable to laser scanning
tomography.
The laser sources contained in the Heidelberg Retina
Angiograph 2 emit laser light of three different wavelengths: for fluorescein angiography, the blue line of
a solid state laser (488 nm) is used to excite the fluorescein. A barrier filter at 500 nm edge wavelength
separates excitation and fluorescent light. The same
wavelength (but without barrier filter) is used to create red free reflectance images. For indocyanine green angiography, a diode laser at 795 nm wavelength is used to excite the dye, while a barrier filter at 810 nm edge wavelength separates excitation and fluorescent light. A second diode
laser at 830 nm wavelength serves to produce infrared reflectance images.
Several image acquisition modes are provided, i.e. pure fluorescein angiography, pure indocyanine green angiography, and simultaneous fluorescein / indocyanine green angiography. In the
simultaneous mode, each image line is scanned twice. During the first scan, fluorescein is excited
and its fluorescence is measured; during the subsequent second scan, indocyanine green is excited
and its fluorescence is measured. In every acquisition mode, individual images, time resolved image sequences, or a focal series of images (layered, three-dimensional images) can be acquired.
The images are immediately digitized with a resolution between 384 x 384 and 1536 x 1536 pixels. The digitized images are stored in the computer's main memory and then saved on the computer's hard disk. The size of the field of view can be set to 15 x 15 degrees, 20 x 20 degrees, or
30 x 30 degrees.
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2 Contraindications, Warnings, Precautions and
Adverse Events
2.1 Contraindications
• Be aware of possible allergic reactions when contrast or dye fluid is injected.
Asked the patient for known allergies and compare it with the contraindications of the
•
contrast or dye fluid.
2.2 Warnings
• Carefully read the instructions for use before operating the device. Misuse of the device
may lead to hazards for patient or user or lead to wrong diagnostic results.
• Do not open the device component housings. Doing so can lead to the possibility of electrical shock and laser radiation. See also subsection “3.4 Instrument Safety” and “3.4.2
Laser Safety”
• Do not use the device outside of the “Intended use” scope. Doing so may lead to malfunctions or damage of the device
• Do not use PCs, components or accessories that have not been approved by Heidelberg
Engineering. Do not install other software programs as they may interfere with the functionality of the Heidelberg Engineering software or equipment. This could include damage to the system as well as incorrect measurement results.
• Do not operate the system without connecting the PC and components to an IEC 60601-1
proven isolation transformer. Doing so could lead to electrical shock to the user and patient in the case of a failure of the PC or to a PC accessory.
• Do not use a network connection without network isolation in accordance to
IEC 60601-1. In case of a failure in the network, there could be a hazard of electrical
shock to the user and patient.
Make sure that the environmental requirements are met when the system is operated. Ex-
•
ceeding environmental conditions might damage the system or lead to wrong measuring
results. (See subsection 7 “Technical Data”).
Make sure the scanners are working (high pitched sound) before installing a patient in
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front of the device. No laser beam should be visible, when the scanners are off. A hazard
for an injury of the retina would exist if the laser beam hits the retina without being
scanned.
• Make sure the patient is correctly placed in front of the camera before starting the examination. Wrong positioning may lead to poor images and wrong diagnostic results.
Artifacts on the images might falsify the measured results. Do not use the measured re-
•
sults for further treatment if there are artifacts in the images.
• Do make a diagnostic decision on one single examination. Always use alternative
information; history data etc. to assist in a final diagnostic determination.
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• Prepare safeguards to ensure that only authorized personnel can access the patient data.
Data loss impedes follow up analyses and may result in wrong diagnostic decision.
• Be sure to perform periodic data backup procedures. Check the success of the backup to
avoid data losses caused by backup errors.
Do not operate the system directly after obvious climate changes. Let the device accli-
•
mate itself for a minimum of 2 hours to avoid device damage or wrong measurement results.
2.3 Precautions
The operator shall be sure that the device settings and adjustments are correct before ex-
•
amination and diagnostic decision. Wrong settings and adjustments may lead to poor image quality or wrong examination information.
The physician shall be sure to have the correct patient data before a diagnostic decision.
•
Mismatched patient data may lead to wrong diagnostic decisions.
• Read chapter “5.1 Preparation” carefully before starting the examination. Incorrect preparation of the patient may lead to poor image quality and incorrect diagnoses.
• Do not start an examination without informing the patient about the examination procedure. Wrong patient behavior during the examination may lead to poor image quality and
incorrect diagnoses.
• Clean and disinfect chin rest and head rest after each examination. Contaminated parts
may lead to infections or disease contraction.
• Read chapter “7.8 Service, Maintenance and Cleaning” carefully. Missing maintenance or
incorrect adjustment of the device may lead to poor image quality and incorrect diagnoses.
• Do not perform more than 1 examination per day on the same patient. Multiple injections
of the contrast or dye fluid may lead to allergic reactions or shock.
• Before starting the system check the regional power supply specifications to verify that
they fit the required tolerances (100V < U < 240V; 50Hz < f < 60Hz). Wrong power
supply conditions might lead to malfunctions of the system.
• Be aware that the influence of other physical effects (vibrations, strong electromagnetic
fields as caused by big machines etc. running close-by), might disturb the proper operating of the device.
• A computer failure during picture acquisition or analysis could lead to incorrect results.
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3 Installation and Safety Information
3.1 Components of the Instrument
The HRA2 system applies to the applicable standards of IEC 60601-1, IEC 60601-1-2, UL2601,
and IEC 60825.
The basic components of the Heidelberg Retina Angiograph 2 are the:
• Laser scanning camera
• Camera mount with headrest
• Touch panel
• Power supply with Laser module
• Computer
• Isolation Transformer
• Operation software.
The laser scanning camera is the core of the Heidelberg Retina Angiograph 2. It contains the
three-dimensional scanning system, the detector and the main part of the electronics. The solid
state 488nm laser source is located in the laser module and is coupled to the camera via an optical
fiber. The diode lasers for infrared and indocyanine green angiography are located in the laser
scanning camera. The scanning laser beam emerges from the objective on the front of the camera.
The intensity of the emitted fluorescent light is also measured through this objective.
The laser scanning camera is mounted on a special camera mount which also contains the headrest for the patient. The camera mount is designed so that the measuring position on the ocular
fundus can be selected by rotating the camera around two orthogonal axes.
The control panel is used to control image acquisition. Here, the basic image acquisition parameters such as angiography type, laser intensity, detector sensitivity, size of the scanning field and
position of the focal plane are specified. The image acquisition itself is initiated from the control
panel.
The laser module contains one solid state laser. The laser light is transmitted into the laser scanning camera via one fiber optic. The laser scanning camera contains two diode lasers.
The power supply supplies voltage to the laser scanning camera. The on/off switch is located on
the front panel. With the switch in position O, the power supply is turned off.
The Heidelberg Retina Angiograph 2 is operated by a PC-compatible personal computer in combibnation with a IEC 60601-1 proven isolation transformer. The computer receives the image data
generated by the laser scanning camera and performs the entire image analysis. For this purpose,
special hardware is installed in the computer in addition to the Heidelberg Retina Angiograph 2
operation software.
The operation software includes functions to communicate with the user, to control image acquisition, to store images and data, to process and analyze the acquired images, and to document the
examination results.
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3.2 Scope of delivery
The scope of delivery for this instrument consists of the following parts:
Laser scanning camera
•
• Touch panel
Foot switch
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• Camera mount with integrated headrest
Power supply with Laser module
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• Frame grabber module for installation in the personal computer
Cable - touch panel to power supply
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• Cable - frame grabber module to power supply
Cable - frame grabber module to camera
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• CD containing operation software
Software protector
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• Operation manual
• Personal computer with hard disk, floppy drive, magneto-optic drive, VGA board, color
monitor, keyboard, mouse, Microsoft Windows 2000/XP operating system.
• Isolation transformer with connector cables.
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eration)
eration)
3.3 Installing the Instrument
(1) Assemble the headrest according to the separate set of instructions. The headrest should be
mounted firmly on the table top.
(2) Place the camera mount onto the sliding platform of the headrest.
(3) Install the frame grabber board into the computer.
(4) Assemble the computer and connect the monitor, keyboard and mouse.
(5) Connect all the power cables (PC, Monitor, Printer and Power Supply) to the isolation
transformer.
Caution:
Do not operate the system without an isolation transformer. Doing so will void the warranty !
It is not allowed to operate PC components in the patients environment without separation via an isolation transformer.
(5) Connect all cables between camera, laser box and PC in accordance to the connection
diagram shown below.
Make sure that all cables are in good condition correctly inserted.
The picture below shows the cable connections to the back of the Laser Box:
camera
Foot Switch
(110 / 230V)
AC- Power Supply
nected to the camera
Metal shielded fiber con-
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Debug and Service interface
Expansion Interface
Data Cable connected to the
(not connected in normal op-
(not connected in normal op-
nected to camera mount
Left- Right recognition con-
nected to the camera
Touch panel interface
Camera power supply con-
the camera
port (COM1, COM2)
Frame grabber Signals to
Frame Grabber Signals from
RS232 interface to PC-serial
PC- Frame Grabber Board
W
ARNING
3.4 Instrument Safety
Important! Before you start working with the instrument, make sure that you know the correct
procedures for turning the instrument on and off (“Chapter 4 General Operating Information”). Do not leave the patient alone with the instrument during the examination.
3.4.1 General Information
The instrument must not be used if there is a mechanical, electrical, or optical defect. Any modifications or additions which are made to the instrument must comply with the relevant legal
guidelines. Any repair, especially of the instrument's electric and electronic systems, and any service work on the instrument components, must only be carried out by appropriately qualified and
authorized staff.
Caution! Unusual noises and/or vibrations may be symptoms of a fault in the instrument.
Please turn the instrument off and contact your local service office. Do not attempt to
repair any faults with the instrument yourself.
3.4.2 Laser Safety
This instrument contains a solid state laser and two diode lasers. The instrument emits visible and
invisible laser light through the objective lens on the front of the laser scanning camera. The Heidelberg Retina Angiograph 2 is a Class 1 laser system. It does not pose any safety hazard whatsoever. The laser class label is located on the rear panel of the camera housing and the rear panel of
the laser module:
LASER CLASS 1
However, hazardous laser radiation may be accessible when the camera housing or the housing of
the laser module is open.
Caution! Never open the housing of the laser scanning camera or the laser module. When the
camera housing or the laser module housing are open, visible and/or invisible laser
radiation of Class IIIB is accessible and can lead to injuries. The camera housing and
laser module housing must only be opened by qualified service staff.
Laser warning labels to this effect are positioned on the cover of the camera housing (underneath
the electronics card which is located there) and on the rear side of the laser module:
LASER BEAM CLASS 3B WHEN
OPEN AVOID DIRECT
EXPOSURE TO BEAM
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To guarantee the safety of the user and the patient at all times, a limit has been imposed on the
maximum period of time for which the laser beam can be switched on. If this limit is exceeded,
the screen shows the message: 'Laser Safety; laser timed out'. Image acquisition is automatically
interrupted and can only be continued after a specified waiting period (about 3 hours). However,
this will not usually occur during normal use of the instrument.
3.5 Care
The Heidelberg Retina Angiograph 2 is a precision optical instrument. Please protect the instrument from dust and moisture, and avoid subjecting it to shocks or strong forces.
The lens surface on the front of the camera should be carefully cleaned at regular intervals (possibly every day). For this purpose, it is best to use acetone and a soft cotton ball.
The non-optical surfaces of the instrument can be cleaned and/or disinfected as usual whenever
necessary. Before doing this, please turn the instrument off and pull out the power plug.
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4 General Operating Information
4.1 Turning the Instrument On and Off
4.1.1 Turning On
To turn the Heidelberg Retina Angiograph 2 on, proceed as follows:
(1) Turn the computer on. After the boot sequence has been completed, the computer will start
the Windows operating system.
(2) Turn on the power supply. The power switch is located on the front panel of the power sup-
ply. The 'off' position is marked O.
(3) Use the Heidelberg Eye Explorer shortcut on the desktop to start the application.
This will start the Heidelberg Eye Explorer software.
Note: It is not recommended to turn the instrument on and off frequently. Even if you are
not using the instrument constantly during the course of a day, it is best to turn it on
in the morning and not to turn it off again until the evening.
4.1.2 Turning Off
To turn the Heidelberg Retina Angiograph 2 off, proceed as follows:
(1) If the acquisition dialog is open and the live image is visible on the screen, stop the image
acquisition with the 'freeze' button on the touch panel and leave the acquisition dialog.
(2) Turn off the power supply. The power switch is located on the front panel of the power sup-
ply. The 'off' position is marked O.
Important! Never turn off the power supply while the laser scanning camera is acquiring im-
ages. This can result in damage to the camera.
Never turn the computer off without quitting the Heidelberg Retina Angiograph 2
operation software first. This can result in the loss of data stored on the computer's hard disk. Before you turn off your computer, select "Shut Down" from
the Windows "Start" menu.
4.2 Controls
4.2.1 Touch Panel
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