Zeiss VISUCAM C User manual

VISUCAM C
DigitalCamera
Gebrauchsanweisung
User´s Manual
Mode d’emploi
Instrucciones de uso

2

000000-1253-546 VISUCAM C 31.07.2003
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Knowledge of this manual is required for the operation of the
instrument. Would you therefore please make yourself familiar with the
contents of this manual and pay special attention to hints concerning
the safe operation of the instrument.
The specifications are subject to change; the manual is not covered by
an update service.
© Unless expressly authorized, forwarding and duplication of this
document, and the utilization and communication of its contents
are not permitted. Violations will entail an obligation to pay
compensation.
All rights reserved in the event of granting of patents or
registration of a utility model.
Copyright

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Windowsis a trademark of Microsoft Corporation, Inc.
In general, other brand names as well as names of software and
hardware products are subject to trademark or patent protection.
Quoting of product names is for information only and does not
represent any trademark misuse.
Trade mark

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Page
Copyright............................................................................................1
Trade mark .........................................................................................2
Contents .............................................................................................3
Safety Notes.......................................................................................5
General .......................................................................................5
Compliance with standards and regulations ................................5
Notes on installation and use.......................................................6
Safe function...............................................................................8
Electrical safety ..................................................................8
Light emission ....................................................................8
Data backup ......................................................................8
Correct use of the instrument......................................................8
Instrument Description......................................................................9
Design of basic unit.....................................................................9
Controls of the VISUCAM C ......................................................10
Connector panel of the VISUCAM C..........................................13
Power isolation transformer for external devices ........................14
Start-up.....................................................................................15
Installation .......................................................................15
Electrical connection ........................................................15
Optional accessories ..................................................................17
Printer..............................................................................17
Fixation device .................................................................17
Demonstration eye with holder ........................................17
USB Flash Drive ................................................................17
Functional description ...............................................................18
Software Description.......................................................................19
Program control ........................................................................19
General remarks on instrument control ............................19
Operation via keyboard and mouse ..................................20
Screen layout ............................................................................ 21
Overview..........................................................................21
Overview of menus and Icons...........................................23
Patient Manager desktop .................................................25
Image capture desktop..................................................... 26
Configuration dialog boxes .......................................................28
System settings ................................................................28
User-specific program settings..........................................29
Contents

Contents
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Survey of Operating Procedure ......................................................35
Operation .........................................................................................36
Preparing image capture............................................................36
Switching the instrument on.............................................36
Entry / editing of patient data...........................................36
Patient selection ...............................................................37
Choosing the image capture mode...................................38
Adjusting the instrument to the patient ............................40
Adjusting the instrument to the patient by infrared
observation ......................................................................41
Capturing images ......................................................................43
Color images (COLOR)......................................................43
GREEN images (REDFREE) .................................................43
RED images ......................................................................44
Presentation of images .............................................................45
Image comparison and image correction....................................46
Printing images..........................................................................49
Printing from the Patient Manager mode..........................49
Export of image data .................................................................51
Import/export patient list ...........................................................53
Switching off the VISUCAM C ...................................................54
Care and Maintenance.....................................................................55
Changing the bulb.....................................................................56
Changing the halogen lampe ...........................................56
Replacing the blinking diode of the fixation lamp .............57
Maintenance notes ....................................................................59
Disposal.....................................................................................59
Troubleshooting table................................................................60
Technical Data ..................................................................................61
Manufacturer's Declaration ............................................................62
Medical Products Act .................................................................62
DICOM Conformance Statement ...............................................62
Index .................................................................................................63
Important for safety:
Safety Notes ................................................................................5
Care and Maintenance ..............................................................55
Troubleshooting table................................................................60

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General
This instrument has been developed and tested in accordance with Carl
Zeiss safety standards and with national and international regulations. A
high degree of instrument safety is thus ensured.
Observe all safety notes and information in this manual and on the
labels on the device. These notes are marked by pictograms:
Danger to the instrument!
Danger to the user!
Type B Medical Device as per DIN EN 60601-1.
Disconnect the power cable before opening the instrument!
Note
Please see Fig. 3 and Fig. 4 for positions of warning and
information signs.
Warning
Correct operation of the VISUCAM C Digital Camera is imperative for
its safe function. Therefore, please read these operating instructions
thoroughly before using the instrument.
You may obtain further information from our service organization or
authorized representatives.
Compliance with standards and regulations
❏ Quality Assurance of Carl Zeiss meets the requirements as laid down
in DIN EN ISO 9001/ DIN EN ISO 13485.
❏ The instrument complies with the EC Medical Device Directive
93/42/EEC and their national equivalent in form of the German
Medical Product Act (MPG) (→Manufacturer’s Declaration on p. 62).
❏ The EC Medical Device Directive (MDD) classifies the device as a Class
I device.
Safety Notes

Safety Notes
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Notes on installation and use
❏ Only appropriately qualified or trained persons are allowed to
operate the VISUCAM C.
❏ Always keep the user’s manual at hand for reference.
❏ Make sure to avoid uncontrolled looking at the light source, for
instance at the objective! Risk of dazzling!
❏ The instrument may only be opened by service technicians employed
with or authorized by Zeiss.
(Exception: Replacement of halogen lamp)
❏ When replacing the halogen lamp, make sure the power cable is
disconnected.
Only use original lamps. The lamps should only be replaced by
trained personnel.
❏ Do not cover ventilation slots.
❏ Never pull at the power cable.
❏ To turn off the instrument, operate the power switch.
❏ The power cable must be connected to a socket with an earth wire.
Avoid the use of an extension cable. Do not interrupt the earth wire
either inside or outside the instrument, as this may endanger
operator, patient and instrument. Interruptions may not be made
intentionally. If the earthing is impaired, or if any electrical leads are
damaged, the instrument must be taken out of service and measures
taken to prevent inadvertent use. Customer service department
should then be informed.
❏ Clean optical components only externally following the instructions
given in this manual.
❏ The instrument must not be operated in an explosion hazard area.
Do not operate the instrument in explosion-risk rooms and in the
presence of flammable anesthetics and volatile solvents, such as
alcohol, benzine or similar agents.
❏ Do not install the instrument in damp rooms. Avoid dripping or
splashing water near the instrument.
❏ Only operate the instrument in combination with the accessories
described in this manual.
❏ Do not use mobile phones and other devices not compliant with
EMC class B in the vicinity of the equipment as their signals may
cause the equipment to malfunction. The effects of the radio signals
on medical instruments depend on various factors and are therefore
not foreseeable.
❏ Observe the relevant regulations for the prevention of accidents.

Safety Notes
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❏ This instrument may only be modified and repaired by service
technicians employed with or authorized by Zeiss. The responsibility
for any other use than the one intended and described herein
exclusively lies with the user.
❏ The retinal exposure dose for a photochemical hazard is a product of
the radiance and the exposure time. If the value of radiance were
reduced in half, twice the time would be needed to reach the
maximum exposure limit.
❏ Because prolonged intense light exposure can damage the retina, the
use of the device for ocular examination should not be unnecessarily
prolonged, and the brightness settings should not exceed what is
needed to provide clear visualization of the target structures.
Additionally the device includes appropriate filters which assure that
the limit values will be met in the pre-determined wavelength limits
as required by the standard ISO 10940 : 1998.
❏ Please also keep patient exposure to a minimum during setting of the
area to be examined with the infrared illumination.
❏ While no acute optical radiation hazards have been identified for the
VISUCAM C, it is recommended that the intensity of light directed
into the patient’s eye be limited to a minimum level which is
necessary for diagnosis. Infants, aphakes and persons with diseased
eyes will be a greater risk. The risk may also be increased if the
person being examined has had any exposure with the same
instrument or any other ophthalmic instrument using a visible light
source during the previous 24 hours. This will apply particularly if the
eye has been exposed to retinal photography.
❏ In the U.S. federal law restricts this device to sale by or on the order
of a Physician or Practitioner (CFR 801.109(b)(1)). The respective
personnel qualification requirements are defined in the appropriate
national directives.
Caution
This instrument is a high-quality technical product. To ensure perfect
and reliable operation, have it checked at least every 12 months by
authorized service technicians.

Safety Notes
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Safe function
Electrical safety
❏ The built-in power supply is short-circuit-proof and does not contain
any externally accessible fuses.
❏ If used properly, the device does not pose an electrical risk to patient
and operator.
❏ Only persons authorized by the manufacturer are allowed to open
the instrument!
Light emission
❏ The instrument emits visible and infrared light. The threshold values
as laid down in DIN EN ISO 15004 ”Ophthalmic Instruments – Basic
requirements and testing methods” are not exceeded.
Data backup
❏ Storing your image data on the hard disk is no substitute for
archiving. We urgently recommend you to export the image data
daily for data backup.
Correct use of the instrument
The VISUCAM C DigitalCamera is suitable for photographing, displaying
and storing the data of the retina and surrounding parts of the eye to
be examined. These photographs support the diagnosis and subsequent
observation of eye diseases which can be visually monitored and
photographically documented.

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Design of basic unit
Fig. 1 Design of basic instrument
Instrument Description
1 Cap for fixation lamp
2 Fixation lamp, freely (3D) movable
3 Headrest with vertically adjustable chinrest, forehead support and mount for fixation lamp
4 Monitor for observation of patient eye and display of instrument-specific information
5 USB Flash Drive (optional accessory)
6 Keyboard and mouse for the entry of patient data and operation of the instrument
7 Instrument base with joystick positioning of camera head, controls for lamp brightness and headrest
8 Camera head containing illumination and viewing system with filters and image sensors
23
4
6
7
8
1
5

Instrument Description
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Controls of the VISUCAM C
Fig. 2 Controls of the VISUCAM C, view from the right
3
2
5
6
4
8
10
11
1
9
7

Instrument Description
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In the right-hand view of the VISUCAM C, the following controls and
components are shown (Fig. 2):
1 Lid of lamp housing
2 Inside fixation device (optional accessory)
3 Fastening pins for paper pads
4 Knurled knob for locking the instrument base
5 Mouse
6 Keyboard
7 Connector panel
8 Control for adjusting the brightness of the halogen lamp
9 Joystick for 3D adjustment of instrument base (X/Y-axis: by tilting;
Z-axis: by turning),
X/Y coarse adjustment by pushing the instrument base into the
desired direction
10 Release button for taking photographs
11 Focusing control

Instrument Description
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Fig. 3 Controls of the VISUCAM C, view from the left
1
2
5
6
3
4
8
7
9 10

Instrument Description
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In the left-hand view of the VISUCAM C, the following controls and
components are shown (Fig. 3):
1 Sleeve nut for fixation lamp
2 Forehead strap for the patient
3 Red eye level marks (patient eye level needed for optimum
photographs)
4 Protective cap of front lens
5 Patient chinrest
6 Knurled sleeve for vertical adjustment of chinrest
7 Type label
8 CD-R/RW drive
9 Warning sign: Disconnect the instrument from the line
10 Information sign: Software package / Software version; Windows
license
Connector panel of the VISUCAM C
Fig. 4 Connector panel
Fig. 4 shows the connector panel:
1 Power switch
2 Power cable
3 Monitor (VGA)
4 2x USB port, preferably for printer (USB)*
5 Camera head connector (DEVICE)
6 Mouse (with USB / PS2 adapter)
7 Keyboard
8 Identification plate and plug ID plate
9 Parallel printer port (LPT1)*
10 Serial port (COM)*
11 Network connector (NET)*
12 Warning sign: Danger zone
Warning
* When connecting external units, observe the safety requirements as
per DIN EN 60601-1-1 (medical electrical systems) (see also next page)!
For the connection to an external network (NET) you can order a
network isolator from Carl Zeiss.
12354
9
10
11
67
8
12

Instrument Description
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Power isolation transformer for external devices
Caution
Make sure you always connect all external devices, printer and monitor,
to the power isolation transformer.
No other components than those system components described may be
connected to the power isolation transformer or instrument table.
Non-compliance presents a violation of the regulations for the use of
medical devices as per DIN EN 60601-1-1.
If you use the IT 3L or IT 2S Instrument Table from Carl Zeiss for the
VISUCAM C, the power isolation transformer can be mounted to the
underside of the tabletop. Otherwise, it must be set up safely, but not
on the floor.
1
2
1Power cable connector with
fuses
2
Power switch
Fig. 5 Power isolation
transformer, front view
2
1
2
2
1Appliance connector
2
Power junction connector
Fig. 6 Power isolation
transformer, rear view

Instrument Description
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Start-up
Installation
As a rule, the following operations are carried out by the user.
❏ Remove and unpack the accessory cardboard box (keyboard, mouse,
etc.).
❏ Remove the instrument from the cardboard box at the plastic taut
strap.
❏ Remove the taut strap and plastic foam pads.
❏ Place the instrument on the table (handle it carefully; do not lift or
carry the instrument at the camera head!).
❏ Remove the plastic-foam transport locks.
❏ To remove the red transport fixation plate, loosen the knurled knob
(4, Fig. 2) and turn the joystick (2, Fig. 7) clockwise until the mark
for the center position of the height adjustment becomes visible
(1, Fig. 7)
❏ Then pull out the plate from the patient side.
❏ If used, plug the fixation lamp into the corresponding mount and
lock it by means of sleeve nut (1, Fig. 3).
Electrical connection
Caution
Before establishing electrical connections, make sure the power plugs
on basic unit and power isolation transformer have been disconnected.
• Connect the cable of the camera head (DEVICE) to the connector
panel (5, Fig. 4) and tighten the two screws.
• Connect the monitor cable (VGA) to the connector panel (3, Fig. 4)
of the VISUCAM C.
• Connect the optional printer to a free USB port of the connector
panel (4, Fig. 4) of the VISUCAM C.
• Connect the keyboard and mouse to the connector panel (6 and 7,
Fig. 4).
• Connect the cable of the USB Flash Drive to a free USB port of the
connector panel (4, Fig. 4) of the VISUCAM C.
• Connect the power cables of monitor and printer to the power
isolation transformer (see Fig. 6).
• Connect the basic unit via power connector (2, Fig. 4) and the
power isolation transformer via power connector (1, Fig. 5) to
separate permanently installed mains power outlets.
The VISUCAM C is switched on by the power switch (1, Fig. 4) located
on the connector panel).
The external units printer and monitor are connected and switched on
via the power isolation transformer.
Note
Please also see the monitor instruction manual.
1Mark for center position
2
Joystick
Fig. 7 Height adjustment
instrument base

Instrument Description
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Caution
The connecting cables of USB components such as printer or USB Flash
Drive may not be plugged and unplugged when the system is being run
up and down. This also applies when the red LED on the USB Flash Drive
is alight. The instrument must be switched off when plugging and
unplugging the USB cable.
Note
If the VISUCAM C is used in connection with a Carl Zeiss
instrument table, the cable connections must be properly secured
with cable clamps and laid in the cable ducts provided.
Also use the VISUCAM C connection diagram enclosed to connect
the system components.
After switch on at the power switches, an internal self-test is run. If the
self-test is successful, you can start working with the instrument.
Some of the operating parameters are set to factory defaults and can be
changed via the Options menu of the VISUCAM C software (refer to
page 29).
Warning
The instrument must be inspected visually before start-up. The
instrument may not be started if it shows obvious signs of damage. In
this case contact the Zeiss Service immediately.

Instrument Description
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Optional accessories
Printer
The printer is used to print the captured images. It is connected either to
a free USB port of the VISUCAM C (4, Fig. 4) or the conventional
parallel port LPT1.
Caution
For operation, observe the corresponding user’s manual provided by
the manufacturer.
Fixation device
The internal fixation device is located directly behind the aspherical
lens. The manipulator allows the fixation point to be moved freely in
this plane. By moving the fixation mark axially along the optical axis, an
ametropia of ±5 D of the patient can be compensated. Every point of
the field of view is accessibly by moving the control handle.
• To install the fixation device, unscrew the stopper and replace it by
the internal fixation device.
Demonstration eye with holder
The demonstration eye is designed for practising the operation of the
VISUCAM C.
When required, plug the holder with the demonstration eye into the
holes of the fastening pins (3, Fig. 2) at the headrest. By moving the
unit longitudinally, an ametropia of ±5 D can be adjusted.
USB Flash Drive
The USB Flash Drive can be used for fast data transfer. It is connected to
a free USB interface of the VISUCAM C connector panel.
Note
The connecting cable to the USB Flash Drive may not be
unplugged and plugged when the system is being run up or
down or when the red LED on the USB Flash Drive is alight. The
instrument must be switched off when plugging or unplugging
the USB cable.
Fig. 8 Fixationseinrichtung

Instrument Description
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Functional description
The VISUCAM C allows the representation of the fundus of the eye with
the pupil being dilated. Easy operation of the camera provides quick
findings. The camera is particularly suitable for routine use. The fundus
of the eye can be assessed on the live image or the higher-quality single
image. Image capture and presentation permitted fully electronically.
The VISUCAM C employs the ophthalmoscope principle of the modern
fundus camera imaging the fundus of the eye at a field angle of 45º
and 25°. The instrument operates in non-contact mode. The setting
(positioning and focussing) can be done with visible light or infrared
light. The use of the infrared light allows you to work with the naturally
dilated pupil (i.e. without mydriaticum).
The halogen lamp used as light source ensures comparability of
captured images with customary ophthalmoscope and contact-lens
examinations.
The capture modes COLOR, RED and GREEN are possible with the
VISUCAM C, video clips can also be recorded if required. Operation is
easy and quickly learned by the user. Camera adjustment (freedom from
reflections, image sharpness) has to be assessed on the monitor.
When capturing images, the set image displayed on the monitor will be
saved as single image of improved quality. Setting errors are almost
precluded (what you see is what you get). The operating principle of the
VISUCAM Ce corresponds to that of a well known digital photographic
camera (adjustment, photographing, printing or exporting).
Capture sensors are special CCD color sensors depending on the image
angle. Observation is exclusively on the 15” monitor.
Dedicated, easily comprehensible software is available for the
adjustments of image capture, presentation and image export or
printout. A patient database ensures the correct assignment of the
images.
Like with a commercial digital camera, images can be stored only
temporarily, i.e. long-term storage of images must be done using an
external archiving system (e. g. VISUPAC /System) or simply by the
keeping of printouts.
Besides, the export of captured images to DICOM files ensures transfer
of all relevant data: images, time and patient data.
A network link or the optionally available USB Flash Drive is
recommended for simple export and transfer to another computer
system.