Heidelberg HRC User manual

Heidelberg Retina
Camera (HRC)

Installation Instructions

Version 001, May 2009

© Heidelberg Engineering GmbH 2009

Art. No. 20924

QM-Nr. 97 128-001

HRC Installation Instructions Vers. 001 1

0482

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).

Caution! Do not use the Heidelberg Retina Camera
without reading this manual. This manual contains
important safety information.

Corporate Headquarters

Heidelberg Engineering GmbH • Tiergartenstr. 15 • 69121 Heidelberg • Germany

Phone [phone] • Fax [phone] • www.HeidelbergEngineering.de

US Main Office

Heidelberg Engineering, Inc. • 1499 Poinsettia Avenue, Suite 160 • Vista, CA 92081

Phone [phone] • Fax [phone] • www.HeidelbergEngineering.com

US Service Center

Heidelberg Engineering, Inc. • 410 Harris Road • Smithfield, RI 02917

Phone [phone] • Fax [phone] • www.HeidelbergEngineering.com

HRC Installation Instructions Vers. 001 2

Table of Contents

1 GENERAL INTRODUCTION ................................................................................................................5

1.1 THE HEIDELBERG RETINA CAMERA......................................................................................................................5

1.2 SAFETY INFORMATION: CAUTIONS AND WARNINGS .......................................................................................5

1.3 MAINTENANCE, CLEANING AND SERVICE..........................................................................................................9

1.4 ACCESSORIES........................................................................................................................................................... 11

2 ELECTRICAL SYSTEM CONFIGURATION.....................................................................................12

3 PC REQUIREMENTS.............................................................................................................................12

4 HARDWARE INSTALLATION ...........................................................................................................13

4.1 CONTROL UNIT (POWER SUPPLY UNIT)............................................................................................................ 14

4.2 HRC CAMERA......................................................................................................................................................... 15

4.3 ASSEMBLY INSTRUCTIONS ....................................................................................................................................16

4.4 CABLE CONNECTIONS........................................................................................................................................... 22

4.5 SOFTWARE PROTECTOR (DONGLE).................................................................................................................... 24

4.6 MOBILE APPLICATION........................................................................................................................................... 25

4.7 MOUNTING AND CHANGING THE LENS ...........................................................................................................25

4.8 FOOT SWITCH .........................................................................................................................................................25

4.9 EXTERNAL FIXATION LAMP.................................................................................................................................. 25

4.10 INSTALLATION OF THE HRC ONTO A SLIT LAMP .......................................................................................... 26

5 TURNING THE INSTRUMENT ON AND OFF...............................................................................27

6 DRIVER AND OPERATING SOFTWARE INSTALLATION.........................................................28

6.1 OPERATING SOFTWARE - FIRST INSTALLATION............................................................................................... 28

6.2 FIREWIRE PERFOMANCE MANGAGER - INSTALLATION ................................................................................32

6.3 VIDEO CONVERTER - DRIVER INSTALLATION ..................................................................................................34

7 TECHNICAL SPECIFICATIONS........................................................................................................37

7.1 OPERATIONAL ENVIRONMENT AND USER TRAINING.................................................................................... 38

7.2 LABELING ................................................................................................................................................................. 39

HRC Installation Instructions Vers. 001 3

HRC Installation Instructions Vers. 001 4

1 General Introduction

1.1 The Heidelberg Retina Camera

The Heidelberg Retina Camera (HRC) is a scanning digital
opthalmoscope for the examination of the anterior and the posterior­segment of the eye with or without contrast or fluorescence agent. The
resulting images aid the physician in the diagnosis and the follow up of
various diseases of the anterior and the posterior-segment of the eye.

1.2 Safety Information: Cautions and Warnings

Please read this section carefully and always follow its contents!

1.2.1 General Safety Information

WARNING The light emitted from this instrument is potentially hazardous. The

longer the duration of exposure, the greater the risk of ocular damage.
Exposure to light from this instrument when operated at maximum
intensity will exceed the safety guideline after 30 minutes.

IMPORTANT Before you start working with the instrument, make sure that you know the

correct procedures for turning the instrument on and off (Chapter 5).

IMPORTANT Carefully read the instructions for use before operating the device. Misuse of

the device may lead to hazards for the patient or the operator or can lead to
wrong diagnostic results. Use outside the “intended use” scope may also lead
to instrument damage.

The instrument must not be used if there is a mechanical, electrical, or optical defect.
Modifications or additions lead to loss of the CE mark. Heidelberg Engineering does not
take responsibility for modified HRC devices.

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 Heidelberg Engineering
or an authorized distributor.

1.2.2 Contraindications for Performing Angiography

• Always ask the patient for known allergies and compare it with the
contraindications of the contrast or dye fluid.

• Be aware of possible allergic reactions when contrast or dye fluid is injected.

HRC Installation Instructions Vers. 001 5

1.2.3 Cautions, Warnings, and Contraindications

WARNING Carefully read the operation manual before operating the device. Misuse of

the device may lead to incorrect diagnostic results.

WARNING Do not examine a patients eye longer then 30 minutes. A too long

examination time might lead to damages of the retina.

WARNING The camera housing can get very hot after continuous operation. It is

recommended to switch off the device between examinations. Caution is
recommended when touching the camera housing.

WARNING Do not open the device component housings. Doing so may result in

electrical shock.

WARNING Do not use the device outside the scope of its “Intended use”. Doing so may

lead to malfunctions or damage of the device.

WARNING Do not use PCs, components or accessories that have not been approved by

Heidelberg Engineering. Do not install other software, as this may interfere
with the functionality of the Heidelberg Engineering software or equipment,
cause damage to the system or lead to incorrect measurement results.

WARNING Always use a network connection with network isolation in accordance with

IEC 60601-1 (isolating transformer). Without isolation transformer, user and
patient could be at risk of electrical shock in the event of an error.

WARNING Make sure that the environmental requirements are met when the system is

operated. Exceeding environmental conditions may damage the system or
lead to incorrect measuring results.

WARNING Wrong examination preparation of the device and the patient may lead to

bad or insufficient pictures.

WARNING Be aware of possible allergic reactions, when contrast or dye fluid is injected.

Closely follow the package information leaflet. Do not perform more than
one examination per day on the same patient. Multiple injections of the
contrast or dye fluid may result in allergic reactions or shock.

WARNING Incorrect application of contrast / dye fluid may cause allergic reactions or

shock, injury or illness. It may also cause follow up treatment or bad
examination results.

WARNING Make sure the patient is correctly positioned in front of the device before

starting the examination. Wrong positioning may lead to poor images and
incorrect diagnostic results.

WARNING Artefacts on the images could falsify the measured results. Do not use the

measured results if there are artefacts in the images.

WARNING Do not make a diagnostic decision on the basis of one single examination.

The device is not clinically evaluated for the diagnosis of specific
pathologies. So always use alternative information; history data etc. to assist
in a final diagnostic determination.

WARNING Prepare safeguards to ensure that only authorized personnel can access the

patient data. Data loss impedes follow-up analyses and may result in
inappropriate diagnostic decisions.

HRC Installation Instructions Vers. 001 6

WARNING Be sure to perform periodic data backup procedures. Check the success of the

backup to avoid data loss caused by backup errors.

WARNING To avoid the risk of electric shock, this equipment must only be connected to

a grounded power supply.

WARNING To avoid the risk of electric shock, do not touch conductive parts of

connectors and the patient simultaneously.

WARNING Do not operate the system directly after large temperature changes. Let the

device acclimate itself for a minimum of two hours to avoid device damage
or incorrect measurement results.

WARNING Clean and disinfect chin rest and headrest or other soiled parts after each

examination, Contaminated parts may lead to infections or disease
contraction.

CAUTION In the rare event of defe

ctive
illumination slit, the live image will
appear as shown to the r

ight. The
image shows a small streak in
horizontal direction on the monitor,
whereas the upper and l
the live image are dar

ower parts of

k. In this case,
please turn the instrument off
immediately and contact Heidelber

g
Engineering or the local distributor.
Do not attempt to repai

r the

instrument yourself.

CAUTION Please evaluate all images concerning their image quality (e.g. brightness,

noises, artifacts) before making a diagnostic decision.

CAUTION Please note that the distance or diameter values issued by the Imaging

software are only pixel values and not correlating to a linear dimension. The
real distances are depending on the camera setup, patient distance and
image quality.

CAUTION If the camera or the objective were fallen off, please contact the Heidelberg

Engineering Service for a device check.

CAUTION Please note that vibrations of the device location (e.g. caused by strong

machines) might lead to bad or distorted images.

CAUTION Never leave the patient alone with the instrument during the examination!

CAUTION The instrument must not be used under any circumstances if mechanical,

optical or electrical faults occur. Any change or addition to the system must
comply with the relevant legal guidelines. Repairs, particularly to the
electronic and optical components, must be carried out only by Heidelberg
Engineering authorized, trained personnel.

HRC Installation Instructions Vers. 001 7

CAUTION Unusual noises and/or vibrations can indicate a fault. Should this happen,

please turn the instrument off immediately and contact Heidelberg
Engineering or the local distributor. Do not attempt to repair the instrument
yourself in the event of a fault.

CAUTION This equipment was tested in accordance to IEC 60601-1-2, Electromagnetic

Compatibility (EMC). Nevertheless, it might be affected by strong
electromagnetic fields. Portable high frequency communication devices may
affect the device.

CAUTION The operator must be sure that the device settings and adjustments are

correct before starting an examination and making any diagnostic decision.
Wrong settings and adjustments may lead to poor image quality or incorrect
examination information.

CAUTION The physician must be sure to have the correct patient data before making a

diagnostic decision. Mismatched patient data may lead to inappropriate
diagnostic decisions.

CAUTION Do not start an examination without informing the patient about the

examination procedure. Inappropriate patient behaviour during the
examination may lead to poor image quality and incorrect diagnoses.

CAUTION Read subsection 1.5 “ Maintenance, Cleaning and Service” carefully. A

failure to carry out maintenance or incorrect adjustment of the device may
lead to poor image quality and incorrect diagnoses.

CAUTION Before starting the system, check the regional power supply specifications to

verify that they comply with the required tolerances. Wrong power supply
conditions may lead to malfunctions of the system.

CAUTION A computer failure during image acquisition or analysis could lead to

incorrect results.

CAUTION Please note that the effect of environment light might influence the image

quality.

United States of America:
Federal law restricts this device to sale by or on the order of a Physician or Practitioner.

IMPORTANT The HRC light bulb is an especially modified component and not an over

the counter product. Only original spare parts from Heidelberg
Engineering GmbH shall be used.

CONTRAINDICATIONS No contraindications are known.

HRC Installation Instructions Vers. 001 8

1.3 Maintenance, Cleaning and Service

The Heidelberg Retina Camera is a precision optical instrument. Protect the instrument
against dust and moisture, and avoid shocks and the action of strong forces.

Beyond the procedures described in this chapter, the operator should not work on the
instrument. Please be aware that only authorized service personnel can do service and
repair of the HRC device. Do not open the camera or power supply unit. If the device is
opened by someone other than an authorized service personnel, the warranty will be
discontinued. For maintenance, adjustment and repair of the equipment contact
Heidelberg Engineering or your local distributor.

A yearly inspection of the device by a Heidelberg Engineering service engineer is highly
recommended to ensure proper and exact operation.

1.3.1 Cleaning and Disinfection

Before cleaning the instrument, turn the instrument off and disconnect the power plug.

The lenses should be carefully cleaned at regular intervals. For this purpose, it is best to use
a cotton swab slightly moistened with 99% ethanol. Do not use disinfection alcohol for
cleaning the optics, as deposits may remain on the lens surface.

The non-optical surfaces of the instrument can be cleaned and/or disinfected as necessary.
Any standard cleaning product appropriate for plastic surfaces which does not contain
acetone or hydrogen peroxide (e.g. ethanol and isopropyl alcohol disinfectants) may be
used for this purpose. Make sure that no cleaning agent penetrates into the equipment.

1.3.2 Changing the Fuse

WARNING: Before changing a fuse the HRC must be switched off and disconnected from the

mains!

The fuses are located in a cartridge (1) in the socket for the mains supply (2) at the back of
the power supply unit.

Remove the cartridge by inserting a small screwdriver behind the flap of the cartridge and
lift the cartridge out of the fuse socket. After exchanging the fuses, insert the cartridge into
the socket.

2

1

1

IMPORTANT: Only fuses with the following specifications are to be used:

100 V-240 V: 2x T 2.0 AL; Size: 5 x 20 mm each, 2-pole fuses.

Always exchange both fuses.

HRC Installation Instructions Vers. 001 9

1.3.3 Changing the Halogen Lamp

WARNING: Before changing a halogen lamp, the HRC must be switched off and

disconnected from the mains!

WARNING: The halogen lamp can be very hot! Wait until the halogen lamp is cool and

use a cloth or metal tweezers to replace the halogen lamp. Only touch the
metal socket of the new halogen lamp, never touch the bulb directly.

To remove the halogen lamp, open the cover which is fixed with a magnet. Remove the
sheet metal protective covering by lifting it up and pressing the lever inside upwards. Pull
the halogen lamp out of the socket in an upward direction.

Insert the new halogen lamp into the ceramic socket using tweezers. Insert the sheet metal
protective covering again, then mount the cover (a pin clasps into position).

IMPORTANT: The HRC bulb is an especially modified component

and not an over the counter product. Only original
spare parts from Heidelberg Engineering GmbH
shall be used.

HRC Installation Instructions Vers. 001 10

1.4 Accessories

The following accessories and spare parts are available:

- Adjustable camera mount with joystick

- Headrest with fixation light

- Exchangeable lenses

- 50° lens for retinal imaging - standard

- 25° lens for ONH imaging - optional

- Anterior segment lens - optional

- Adapter for the following slit lamps

- HS BM/BC 900

- HS BQ 900

- Variable adapter for HS

- CZ 20/30 SL

- CZ 120/160 SL

- RO 2000

- RO 4000/5000

- CSO SL 980

- Halogen lamp 6V/35W, item order no. 18947

HRC Installation Instructions Vers. 001 11

2 Electrical System Configuration

The HRC 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 standards and in this document.

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.

Example: The HRC is connected to a laptop computer, the laptop computer is connected to
a printer (via USB or WLAN). All devices are connected to the main power supply using a
multiple socket outlet. An electrical table is also connected to the same multiple socket
outlet. In this case, the “ME-system” consists of all devices: HRC, laptop, printer and table.

The basic principle when setting up a ME-system is that the overall safety of the system
inside the patient environment is comparable to the safety of a single medical device. To
ensure this, nonmedical devices that are part of the system must conform to their
respective IEC or ISO standards (e. g. IEC 60950) and additionally must conform to the
leakage current limits of the 60601-standard for medical devices.

Caution: Use isolation transformer conforming to IEC 60601-1.

Note that every

3 PC Requirements

The laptop or desktop computer to be used for the HRC must mee the following
requirements:

Operating System: Windows 2000 professional or Windows XP professional

Processor: 1.7 GHz Intel Pentium III (minimum)

RAM: 512 MB minimum

VGA Board: High performance VGA board with at least 1024 x 768 resolution,

16 bit

Monitor: 1024 x 768 minimum resolution

High-Speed Interface: IEEE1394 (FireWire / i.LINK) interface (1 port required)

HRC Installation Instructions Vers. 001 12