Heidelberg HRT3 Installation manual
Heidelberg Retina Tomograph 3
Installation and
System Configuration
© Heidelberg Engineering GmbH 2005
Printed in Germany
Art. No. 97107-002
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Table of Contents HRT 3 Installation and System Configuration
Ta b l e o f C o n t e n t s
TABLE OF CONTENTS .................................................................................................................................................3
GENERAL INFORMATION.........................................................................................................................................4
THE MEDICAL DEVICE HRT 3.........................................................................................................................................................4
THE HRT 3 SYSTEM ............................................................................................................................................................................4
REGULATORY ISSUES...........................................................................................................................................................................4
SAFETY INFORMATION .......................................................................................................................................................................5
HARDWARE INSTALLATION....................................................................................................................................6
UNPACKING THE HRT 3....................................................................................................................................................................6
INSTALLING THE EXTERNAL FIXATION LIGHT..............................................................................................................................9
SETTING UP CABLE CONNECTIONS.............................................................................................................................................. 11
ELECTRICAL SYSTEM CONFIGURATION.......................................................................................................... 13
LEAKAGE CURRENTS .......................................................................................................................................................................13
MAINS POWER CONNECTION ....................................................................................................................................................... 14
ELECTROMAGNETIC COMPATIBILITY........................................................................................................................................... 15
SYSTEM CONFORMANCE ................................................................................................................................................................ 15
LIST OF SYSTEM COMPONENTS .....................................................................................................................................................15
PC REQUIREMENTS.................................................................................................................................................. 16
DRIVER AND OPERATING SOFTWARE INSTALLATION .............................................................................. 17
DRIVER INSTALLATION ...................................................................................................................................................................17
OPERATING SOFTWARE INSTALLATION ......................................................................................................................................19
APPENDIX A: HEYEX.INI SETTINGS................................................................................................................... 24
APPENDIX B: HRTS.INI SETTINGS ...................................................................................................................... 28
FREQUENTLY ASKED QUESTIONS ...................................................................................................................... 29
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HRT 3 Installation and System Configuration General Information
General Information
The Medical Device HRT 3
The Heidelberg Retina Tomograph 3 (HRT 3) is a confocal laser-scanning device for the acquisition and
analysis of three-dimensional images of the eye. The instrument specifically enables the quantitative
description of the optic nerve head topography and time-related changes to it.
The most important routine clinical application of the Heidelberg Retina Tomograph 3 is to detect
glaucomatous damage of the optic nerve head and the follow-up of glaucomatous progression. Another
application is the measurement of retinal thickness maps for the diagnosis of retinal edema. Additionally
the HRT 3 can be fitted with the optional Rostock Cornea Module that allows three-dimensional imaging of
the cornea.
The HRT 3 System
The HRT 3 cannot be used alone. The minimum system configuration consists of a HRT 3 device, a
personal computer with a display (e.g. a laptop or a desktop PC with a monitor) and the interconnecting
cables.
The HRT 3 together with the connected computer and other connected devices constitutes a medical
electrical system (“ME system”) according to IEC 60601-1-1. This system must meet specific safety criteria
as detailed in the standard and in this document. Note that every connected device will become part of the ME-
System even if the only connection is the power supply cord leading to a shared multiple socket outlet.
WAR N ING The ME system may only be assembled by qualified personnel with training and
knowledge in electrical safety, heeding all instructions and safety warnings contained in
this document. It is especially important that all users that de-install and reinstall the
system (for example in a mobile use scheme) are trained to do this in a safe way.
For setting up a safe system it is essential to read and understand the below sections Electrical System
Configuration and Safety Information. These sections summarize the standard’s requirements.
Regulatory Issues
The HRT 3 complies with the international IEC 60601 standard series concerning medical electrical
equipment. These standards are published by the International Electrotechnical Commission and are the
base of most national and regional standards for medical electrical equipment worldwide.
Some local standards contain deviations from the IEC versions. These standards include UL 60601-1
(USA), CAN/CSA C22.2 No. 601.1 (Canada), JIS T 0601-1 (Japan), AS 3200.1.0. (Australia) and others.
Wherever IEC 60601-Standards are mentioned inside this document, the according regulations of respective local
standards are also implied.
NOTICE Even though the HRT 3 already conforms to most local standards for medical devices in its
default configuration, actual conformance can only be ensured by buying it from your
authorized local Heidelberg Engineering distributor.
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General Information HRT 3 Installation and System Configuration
Safety Information
This section contains important safety information. Please read it carefully!
WAR N ING To avoid the risk of electric shock, the system must be installed in accordance to IEC
60601-1-1 or the corresponding local standard particularly with regard to the electrical
leakage currents (see section “leakage currents”). Every modification to the system
requires a new evaluation of the requirements of said standard.
WAR N ING If your system configuration includes a multiple socket outlet, do not place it on the floor
as this entails the risk of liquid ingress or accidental mechanical damage.
WAR N ING Do not connect an additional multiple socket outlet or an extension cable to the system.
This would lead to increased protective earth impedance and therefore to an increased
risk of electric shock.
WAR N ING Do not connect additional devices to the system that are not part of the system or not
specified as compatible to the system.
WAR N ING Do not use multiple socket outlets that are part of the HRT 3 system for other devices that
are not part of the system (e.g. office equipment, domestic appliances). This would lead to
increased electrical leakage currents and therefore to an increased risk of electric shock
for both patient and operator.
WAR N ING Devices intended to be used together with a separating transformer (or ‘isolating
transformer’) may not be used without that transformer. A bypass of the separating
transformer may lead to excessive electrical leakage currents and therefore to an
increased risk of electric shock.
WAR N ING Do not touch the patient and parts inside access covers or contacts of connectors of
nonmedical devices simultaneously.
WAR N ING Carry out all cleaning, adjustment, sterilization and disinfection procedures as specified
in the enclosed instructions for use of the particular system components. Refraining from
that may lead to infections or to bad measurement results that again may lead to a false
diagnosis.
If a multiple socket outlet is used as part of the system, it must conform to IEC 60601-1-1, in particular it
must only allow connection of power cords by using a tool.
All parts of the system can be used inside the patient environment if the requirements defined in this
document and in the according standards are met.
For instructions for cleaning and permissible environmental conditions, see the enclosed instructions for
use of the particular system component.
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HRT 3 Installation and System Configuration Hardware Installation
Hardware Installation
Unpacking the HRT 3
Carefully open the HRT 3 box (view from the top):
Cables, external
Fixation lamp
User Manual,
other documents
Remove the box on the right with the HRT 3 accessories (cables and external fixation lamp):
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Hardware Installation HRT 3 Installation and System Configuration
Remove the top foam cover:
Remove the bottom right foam cover:
Recessed grips
at instrument base
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HRT 3 Installation and System Configuration Hardware Installation
Take the whole HRT 3 system out of the box, using the two recessed grips on the bottom of the system and
place it on a plane surface:
Remove the front foam cover:
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Hardware Installation HRT 3 Installation and System Configuration
Remove the bottom foam cover:
Installing the External Fixation Light
The external fixation light is part of the HRT 3 accessories:
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