Different symbols used in this manual draw your attention to safety aspects and useful tips. These symbols are explained in the following.
Warning!
The warning triangle indicates potential sources of danger which may
constitute a risk of injury for the user or a health hazard.
Caution:
The square indicates situations which may lead to malfunction, defects,
collision or damage of the system.
Note:
The hand indicates hints on the use of the system or other tips for the
user.
®
OPMI
GmbH
and Retrolux® are registered trademarks of Carl Zeiss Surgical
.
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Contents
3
–Key to symbols 2
Functions at a glance 7
–OPMI® VARIO 8
–S88 floor stand 10
Safety 13
–Notes on installation and use 15
–Phototoxic retinal injury in eye surgery 21
–Safety devices of the suspension systems 26
–Warning labels and notes 32
Description 37
OPMI Vario Retrolux System 38
–Intended use 38
–Components of the OPMI Vario Retrolux System 38
Components of the surgical microscope 40
–Controls, displays, connections 42
–Binocular tubes and eyepieces 50
–Retrolux illumination module 54
Components of the S88 floor stand 56
–Description of the modules 57
–Design 58
–Display field with control keys 60
–Lamp housing with xenon light source 62
–Suspension arm 68
–Stand base with column 70
–Connector panel 72
–Instrument tray (option) 74
–Video monitor (option) 76
Foot control panel (option) 84
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4
–Intended use 84
–Design 84
–Foot control panel with 14 functions 86
–Foot control panel with 8 functions 87
Preparations 89
Attaching the equipment 90
–Mounting the surgical microscope 90
–Attaching accessories 92
–Mounting the tube and eyepieces 94
–Mounting the Retrolux illumination module 96
–Bringing the Retrolux illumination module into its standby position
100
–Attaching the fundus imaging system to the illumination module 102
Connections 104
–Connecting the surgical microscope 104
–Mounting the light guide 104
–Aligning the X-Y coupling 108
–Strain relief device on S88 floor stand 110
–Connecting the S88 floor stand 112
Adjusting the supension system 114
–Adjusting the balance setting of the suspension arm 114
–Adjusting the limit of downward movement 116
Balancing the surgical microscope 118
Settings on the control and display panel 120
–Adjusting the suspension system 120
Adjusting the surgical microscope 121
Surgical microscope with a laser micromanipulator 123
Relocating the system 126
Operation 129
Checklist 130
Positioning the S88 floor stand 134
Using the display and key field 136
–General functions 136
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–OPMI Vario on the suspension system, user interface
with SpeedFokus option 140
Procedure 160
What to do in an emergency 162
–Failure of a xenon lamp 162
–Failure of lamp control 164
–Failure of the zoom function 165
–Failure of the focusing function 166
–Failure of magnetic brakes 167
Maintenance / Further information 169
–Trouble-shooting 170
–Changing the xenon lamp module 178
5
–Adjusting the monitor arm 180
–Magnifications / Fields of view 182
–Care of the unit 184
–Sterilization 185
–Disinfecting the control keys 186
–Ordering data 188
–Spare parts 190
–Accessories 191
–Disposal 193
Technical data 195
–Technical data of OPMI VARIO 197
–Technical data of S88 floor stand 198
–Ambient requirements 205
–CE conformity 205
–Changes to the system 205
Index 207
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6
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Functions at a glance7
Functions at a glance
OPMI® VARIO 8
S88 floor stand 10
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8Functions at a glance
OPMI® VARIO
1Adjusting the eyecup and the prescriptionpage 52
2Adjusting the interpupillary distancepage 50
3Adjusting the friction of vertical adjustmentpage 42
4Recentering the X-Y couplingpage 48
5Adjusting the friction of the OPMI® axis of rotationpage 48
6Manual zoom settingpage 44
7Manual focusingpage 44
8Manual setting of the illuminated field diameterpage 44
9Connecting the light guidepage 104
10 Balance setting of the microscope's
front-to-back tilt
11 Balance setting of the microscope's
lateral tilt
12 Motorized focusingpage 46
13 Motorized zoom settingpage 46
14 Display of the magnification factor of
the zoom system
15 Releasing the magnetic brakespage 46
16 Programmable release buttonspage 46
17 Switching off the electrical drive of the
focusing system
18 Connecting the mouth switchpage 42
page 42
page 42
page 42
page 44
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Functions at a glance9
5
186
1234
7811 12131415 16 17910
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10Functions at a glance
42153
S88 floor stand
Xenon illumination system
1Selecting a filterpage 64
2Manual activation of backup lamppage 62
3Resetting the counterpage 64
4Opening the lamp modulepage 64
5Red segment is lit - backup lamp is in usepage 62
6Control panelpage 66
7Lamp housing of xenon illumination systempage 62
8Unlocking the magnetic brakes of the suspension
system
9Limiting the suspension arm's downward movementpage 116
10 Removing/mounting the coupling for the
surgical microscope
11 Balance settingpage 68
12 Locking the stand in positionpage 70
13 Locking the suspension arm in its horizontal positionpage 68
14 Connecting the foot control panel or hand switch,
connecting the remote control connector
15 Rated voltage displaypage 72
16 Connector panelpage 72
17 Turning on the suspension systempage 72
page 68
page 68
page 72
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Functions at a glance11
6798
1011
12913 14 15, 16, 17
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12Functions at a glance
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Safety
Safety13
Notes on installation and use 15
Phototoxic retinal injury in eye surgery 21
Safety devices of the suspension systems 26
Warning labels and notes 32
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14Safety
The device described in this manual has been designed and tested in accordance with Carl Zeiss safety standards as well as German and international standards. This guarantees a high degree of instrument safety.
The system described in this user manual has been designed in compliance with the requirements of:
–EN–IEC–UL–CSA
In accordance with Directive 93/42/EEC for medical devices, the complete quality management system of the company Carl Zeiss Surgical
GmbH, 73446 Oberkochen, Germany, has been certified by DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a
notified body, under registration number 250758 MP23.
–As per Directive 93/42/EEC, the unit is a Class I instrument.
–For USA: FDA classification Class I.
We would like to provide you with information about safety aspects which
must be observed when handling this device. This chapter contains a
summary of the most important information concerning matters relevant
to instrument safety.
Important safety information has been incorporated in this manual and is
marked with a warning triangle accordingly. Please give this information
your special attention.
The correct use of the system is absolutely vital for safe operation. Please
make yourself totally familiar with the contents of this manual prior to startup of the instrument. Please also observe the user manuals of any additional equipment. Further information is available from our service department or from authorized representatives.
•Please observe all applicable accident prevention regulations.
•The instrument must be connected to a special emergency backup
line supply in accordance with the regulations or directives which apply in your country.
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Safety15
Notes on installation and use
Safe working order
•Do not operate the equipment contained in the delivery package in
–explosion-risk areas,
–the presence of inflammable anesthetics or volatile solvents such
as alcohol, benzine or similar chemicals.
•Do not station or use the instrument in damp rooms. Do not expose
the instrument to water splashes, dripping water or sprayed water.
•Switch off the unit at the power switch if you notice any smoke, sparks
or unusual noise. Do not use the unit until it has been repaired by our
service team.
•Do not place any fluid-filled containers on top of the instrument. Make
sure that no fluids can seep into the instrument.
•Do not force cable connections. If the male and female parts do not
readily connect, make sure that they are appropriate for one another.
If any of the connectors are damaged, have our service representative
repair them.
•Potential equalization: The instrument can be incorporated into potential equalization measures. For this purpose, contact our service department.
•Do not use a mobile phone in the vicinity of the equipment because
the radio interference can cause the equipment to malfunction. The effects of radio interference on medical equipment depend on a number
of various factors and are therefore entirely unforeseeable.
•Modifications and repairs on these instruments or instruments used
with them may only be performed by our service representative or by
other authorized persons.
•The manufacturer will not accept any liability for damage caused by
unauthorized persons tampering with the instrument; this will also forfeit any rights to claim under warranty.
•Over longer distances (e.g. removal, return for repair, etc), the instrument may only be transported in the original packaging or in special
return packaging. Please contact your dealer or the Carl Zeiss service
team.
•Use this instrument only for the applications described.
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16Safety
•Only use the instrument with the accessories supplied. Should you
wish to use other accessory equipment, make sure that Carl Zeiss or
the equipment manufacturer has certified that its use will not impair
the safety of instrument.
•Only personnel who have undergone training and instruction are allowed to use this instrument. It is the responsibility of the customer or
institution operating the equipment to train and instruct all staff using
the equipment.
•Keep the user's manuals where they are easily accessible at all times
for the persons operating the instrument.
•Never look at the sun through the binocular tube, the objective lens or
an eyepiece.
•Do not pull at the light guide cable, at the power cord or at other cable
connections.
•This instrument is a high-grade technological product. To ensure optimum performance and safe working order of the instrument, its safety
must be checked once every 12 months. We recommend having this
check performed by our service representative as part of regular maintenance work.
If a failure occurs which you cannot correct using the trouble-shooting
table, attach a sign to the instrument stating it is out of order and contact our service representative.
•Observe the labels showing the symbol "Risk of crushing“!
Notes on EMC (electromagnetic compatibility)
The system meets the EMC requirements of IEC 60601-1-2. During use
of the system, the precautionary measures concerning EMC listed below
must be observed.
Only use accessories that have been approved by Carl Zeiss for this
system.
Do not use any portable or mobile high frequency communication devices
in the vicinity of the system, as this may lead to an impairment of its function.
The system complies with the limits for a Class A device concerning radio
frequency emission. However, the possibility of interference to high frequency receiving devices (e.g. TV sets or radios) being used in the surroundings cannot be ruled out. If interference of this type occurs, please
inform your Carl Zeiss Service.
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Safety17
Connection of a laser micromanipulator
The link-up of a laser micromanipulator with the OPMI results in a medical
system for which the system manufacturer must meet the necessary requirements (approval, qualification, laser protection, etc.). Please note
the user manuals provided by the laser micromanipulator manufacturer
and laser manufacturer. Further information is available from our service
department or from authorized representatives.
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18Safety
Connection of navigation systems (option)
The Carl Zeiss components "Surgical microscope on suspension system"
can be integrated into an external navigation system. An optional navigation interface is available.
•The manufacturer of the external navigation system (system supplier)
is responsible for the following:
–Confirmation that his navigation systems have been tested and
–Meeting all requirements (approval, qualifications, etc.) for the
–Provision of all accompanying documents required.
certified for operation with the respective Carl Zeiss surgical microscope on a suspension system in accordance with the requirements specified in the Carl Zeiss interface description "Navigation
Interface for Carl Zeiss Surgical Microscopes".
medical system created through coupling via the navigation interface.
–Ensuring that the navigation system is only connected by person-
nel who have undergone appropriate training and instruction.
–Contacting the local Carl Zeiss representative for any inquiries that
may arise.
–Implementation of a procedure that guarantees the calibration of
the surgical microscope which is absolutely vital for the use of the
Carl Zeiss components "Surgical microscope on suspension system" in combination with a connected navigation system.
This allows the calibrated surgical microscope combined with the
navigation system to be used like an optical pointer with a variable
length (corresponds to the working distance).
–Conducting complete functional testing, alignment and calibration
(landmark test) of the navigation system after every subsequent installation or exchange of navigation system components
–Incorporation of a regularly changing icon in the data injection dis-
play of surgical microscopes equipped with a data injection system, i.e. the "heartbeat" of the navigation system must be
constantly visible for the user to permit data transmission errors to
be immediately detected.
•To check the accuracy of the overall system, perform the test specified
by the navigation system manufacturer, e.g. the landmark test, also
using the surgical microscope. This allows you to ensure that the stereotactic data has been correctly generated and transmitted to the navigation system without errors.
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Safety19
•Do not use any rotatable tube dovetail mounts when operating the surgical microscope with a connected navigation system. If mounts of this
type have been attached to the microscope, they must be carefully
locked in their central positions (tighten the knurled screw for rotation).
Requirements on the antenna design (non-Zeiss antennas)
•The antenna manufacturer must confirm that his antenna has been
tested and certified for operation with the respective Carl Zeiss surgical microscope on a suspension system in accordance with the requirements specified in the Carl Zeiss interface description
"Navigation Interface for Carl Zeiss Surgical Microscopes".
•The following requirements, in particular, apply to the antenna:
–The surgical microscope with accessories and the antenna must
not exceed the admissible total weight (see label or the chapter
"Technical data").
–The antenna must not project over the bottom edge of the micro-
scope body in the direction of the surgical field.
–The antenna must neither obstruct the movement and adjustability
of the accessories which can be used on the surgical microscope
(usually a stereo coobservation tube, a camera adapter, a face-toface tube for spinal surgery, a laser micromanipulator) nor collide
with these accessories.
–The antenna configuration must be implemented in such a way
that the localizer camera can always "see" the diodes or trackballs
when the surgical microscope and its accessories are in their usual
positions.
–When the system's internal antenna wiring is used, the EN60601-
1-2 standard (electromagnetic compatibility) must be complied
with.
–The output power of the LEDs or infrared LEDs (IRED) must al-
ways comply with the IEC 60825 laser safety standard, even in the
event of cable defects.
–The failure of one or several LEDs of the antenna may impair nav-
igation or lead to navigation failure. Take the necessary precautions.
Requirements for operation
•Our service representative or an expert authorized by us will install the
system. Please ensure that the following requirements are met for further operation:
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20Safety
–All connecting components (details in the user's manual) which are
–All cables and plugs are in perfect condition.
–The voltage set on the instrument corresponds to the rated line
–The power cord has been plugged into a power outlet which has a
–The power cord being used is the one designed for use with this
Before every use and after re-equipping the instrument
•Make sure that all ”Requirements for operation” are fulfilled.
•Go through the checklist.
relevant to system safety have been properly connected, and the
screw connections have been firmly tightened.
voltage on the site of installation.
properly connected protective ground contact.
system.
•Re-attach or close any covers, panels or caps which have been removed or opened.
•Pay special attention to warning symbols on the instrument (triangular
warning signs with exclamation marks), labels and any parts such as
screws or surfaces painted red.
•Do not cover any ventilation openings.
For every use of the instrument
General
•Never operate the system unattended.
•Avoid looking directly into the light source, e.g. into the microscope objective lens or a light guide.
•When the illumination is on, the light guide must be connected at both
ends. Otherwise there is a risk of fire or burn injuries.
•Make sure that the instrument has been switched off before you
change the xenon lamp module. When switched on, the ignition system generates high voltage.
•The xenon illumination system is a high-intensity light source which if used improperly - can cause thermal injury to skin or tissue. Keep
the exposed tissue moist and provide sufficient irrigation. Carefully
monitor the effects of the illumination on the tissue, in particular in the
following cases:
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Safety21
–during prolonged procedures on skin and tissue using objective
lenses with a short focal length (short working distance),
–during procedures on tissue with a low blood supply,
–with high brightness settings of the xenon lamp.
Warning!
Due to the high luminance of the xenon lamp and its light spectrum, which
resembles that of natural daylight, its use in ophthalmic applications is
only permissible in combination with the Retrolux illumination module.
•Any kind of radiation has a detrimental effect on biological tissue.This
also applies to the light illuminating the surgical field. Please therefore
reduce the brightness and duration of illumination on the surgical field
to the absolute minimum required.
•Using the locking pedal on the base, secure the stand in position.
Make sure that the stand is stable and cannot roll away.
After every use of the instrument
•Always use the main power switch of the instrument to turn it off.
•The main power switch must always be turned off when the instrument
is not in use.
Phototoxic retinal injury in eye surgery
General
1)-5)
Several papers
surgery have been published. A comprehensive review of these publications reveals five aspects of particular concern:
Studies on the exposure of the eye to light of varying spectral composition
date back to the early 1950s. These studies suggest that the potential
hazard of phototoxic injury to the patient's retina can be reduced by
blocking out the blue and ultraviolet light below a wavelength of 475 nm.
An important point to note here, however, is that the use of filters will inevitably change the perceived color of the light. For this reason, the physician may initially have to get used to the changed appearance of the anatomical structures.
Illumination intensity
The majority of researchers suggest that the surgeon should use the
lowest light intensity required at the patient's eye to guarantee good
viewing during surgery.
Carl Zeiss has addressed this aspect by providing its systems with a device for continuously varying the brightness of the light source. This permits the surgeon to optimally adapt the light intensity at the patient's eye
to the conditions existing in each case.
Angle of illumination
1)-4)
A number of publications
suggest that the microscope should be
tilted to reduce the exposure of the macula to direct illumination.
Carl Zeiss ophthalmic surgical microscopes are therefore equipped with
the following:
–Tilting mechanism for the microscope body
Focus of the light source
Studies show that injuries are likely to occur if the filament of the light
source is imaged on the patient's retina. The peak intensity of a filament
is considerably higher than that of an even and extended light source
such as a light guide.
This is the reason why Carl Zeiss uses fiber optic illumination in its surgical microscope systems.
Exposure time to light
According to some publications, the phakic and aphakic eye should not
be exposed to the light source longer than a few minutes. In all surgical
cases, the retinal exposure time depends on the type and duration of the
procedure and possible case complications. It is therefore recommended
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Safety23
in ophthalmic surgery to keep the light intensity as low as possible, or to
use a device which prevents the light from entering through the patient's
pupil. It is alsorecommended to make sure that the patient's eye is not additionally exposed to the light of surrounding light sources. This problem
has been solved by Carl Zeiss by the use of a retinal protection device that
can be swung into the illumination beam path of the Retrolux illumination
module.
Brightness control
The brightness control scale of our systems has a linear structure with
values ranging from 1 to 10. The stipulations of standard ISO/DDIS
15004-2:2006(E) result in maximum radiation exposure times for the different illumination configurations as specified in the table "Maximum radiation exposure times".
The microscope light source - like any bright light source - may present a
hazard to the patient's eye both in the form of immediately visible thermal
damage to the retina as well phototoxic chemical reactions which may
lead to photoretinitis. The factors which play an important role in determining the phototoxic risk are:
–Lamp brightness.
–Spectral distribution of the light (UV and blue are more dangerous
that longer wavelengths).
–Duration of direct exposure.
–Pupil size.
–Clarity of ocular media (infants and young children, for example,
may be at a higher risk).
–Phakic status of the eye (aphakic and pseudo-aphakic eyes with-
out UV and blue filtering IOLs are at a higher risk).
–Previous exposure to bright light such as retinal photography, es-
pecially within the last 24 hrs.
The following table is intended to provide the surgeon with a guideline in
determining the potential hazard. The data has been calculated for a
worst-case scenario of direct, uninterrupted exposure of an aphakic eye
with an 8 mm dilated pupil. The calculations are based on the recom-
6)
mended occupational health daily exposure limits as defined in
. A
safety factor of 10 has been used in determining these limits.
During cataract procedures, factors such as lenticular material, instruments such as the phaco handpiece, and movement of the eye provide
interruption of the exposure and would be expected to significantly
lengthen the time before photoretinits might be expected to occur.
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24Safety
A prospective study 7) of the effects of microscope illumination during surgery did not reveal any phototoxic retinal injuries for procedure times of
up to 30 minutes if the calculated maximum recommended exposure time
was 150 seconds. However, it was also found that at the same brightness
setting, phototoxic retinal injury could be expected after approximately
100 min.
Carl Zeiss recommends the following measures in order to minimize phototoxic risk:
•Always use the lowest possible brightness setting.
•When working on the exterior eye, use the retinal protection device to
prevent light from entering the pupil, especially when the pupil is dilated.
•Turn off the microscope illumination system or cover the patient's eye
during pauses in surgery.
The following table shows the maximum radiation exposure to the xenon
illumination.
Maximum radiation exposure times
Illumination display scaleMax. exposure time
2,53.4 minutes
5,01.5 minutes
7,51.0 minutes
100.8 minutes
Warning!
This exposure time must not be exceeded, as serious eye injury could
otherwise be caused by the xenon illumination.
Note:
A UV blocking filter is contained as a standard feature in the Retrolux illumination module on the microscope side.
This helps the surgeon to reduce the risk of phototoxic retinal injury in the
patient.
List of references
1)
H. Stiller, and B. Rassow, "Light hazards to the patient's retina from
G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
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Safety25
2)
American Conference of Governmental Industrial Hygienists, "Documentation of the Threshold Limit Values for physical agents. 7th Edition,"
(American Conference of Governmental Industrial Hygienists, Cincinnati,
2001).
3)
S. G. Khwarg, F. A. Linstone, S. A. Daniels, S. J. Isenberg, T. A.
Hanscom, M. Geoghegan, and B. R. Straatsma, "Incidence, risk factors,
and morphology in operating microscope light retinopathy," Am. J. Ophthalmol. 103, 255-263 (1987).
4)
G. Kleinmann, P. Hoffman, E. Schechtman, and A. Pollack, "Microscope-induced retinal phototoxicity in cataract surgery of short duration,"
Ophthalmology 109, 334-338 (2002).
5)
ISO/FDIS 15004-2:2006(E) Optical instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection
6)
David Sliney, Danielle Aron-Rosa, Francois DeLori, Franz Fankhauser,
Robert Landry, Martin Mainster, John Marshall, Bernard Rassow, Bruce
Stuck, Stephen Trokel, Teresa Motz West, and Michael Wolffe, Adjustment of guidelines for exposure of the eye to optical radiation from ocular
instruments: statement from a task group of the International Commission
on Non-Ionizing Radiation Protection (ICNIRP) APPLIED OPTICS Vol.
44, No. 11, p 2162 (10 April 2005)
7)
Byrnes, G.A., Antoszyk, A.N., Mazur, D.O., Kao, T.C., Miller, S.A.,
Photic maculopathy after extracapsular cataract surgery. A prospective
study, 1992/05/01 Ophthalmology, VL - 99, IS - 5, SP - 731, EP - 737,
PB - Elsevier
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26Safety
Safety devices of the suspension systems
1Release bar
Allows non-sterile persons to release the magnetic brakes of the suspension system.
2Adjustment screw for limiting the downward travel
Use this screw to set the minimum vertical distance (working distance)
from the surgical field. Check this setting before
dure.
3Locking knob
for locking the suspension arm in its horizontal position.
Before removing or attaching a unit (microscope, tube, etc.), move the
suspension arm into a horizontal position. Pull out the locking knob
and turn it clockwise or counterclockwise through 180°, while slightly
moving the suspension arm up and down until the lock engages.
When locked, the suspension arm can no longer suddenly spring upward when insufficient weight is attached. After attaching a unit, perform the balancing procedure.
each surgical proce-
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Safety27
1
1
2
3
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28Safety
Xenon illumination system
Warning!
The xenon lamp has a limited service life of 500 h.
If used beyond its maximum service life, the xenon lamp may explode.
•Replace the xenon lamp in good time.
•Reset the service hour counter to "0" after replacing the lamp.
1Switching to the backup bulb
The lamp module contains two xenon bulbs. The second bulb is used
as a backup bulb which must be swung into the illumination beam path
if the first bulb fails.
•If the xenon bulb fails, open the lamp module as follows: Press
button (7). The lamp module is slightly ejected.
•Pull out the lamp module as far as it will go.
•Turn knob (1) 180° until it snaps in place. This moves the backup bulb
into the illumination beam path.
•Push the lamp module all the way back into the lamp housing.
•Reset service hour counter (6) to "0". Use a pointed object and press
it into the recess of reset button (5).
2Indicator: backup bulb is in use
When the red segment in the knob (1) lights up, the backup bulb is in
use.
Note:
If the first bulb has failed and the backup bulb is in use, make sure to
have a backup lamp module at hand as a precaution.
3Yellow indicator lamp
Lights when the bulb has failed, or if the lamp module is defective.
After activation and ignition of the backup bulb, the yellow indicator
lamp turns off again.
4Manual function
When the manual function has been activated, all electrical control
systems are disabled. The bulb brightness is automatically adjusted to
a fixed setting.
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Safety29
3
4
7
1
2
256
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30Safety
Manual function
1Manual key
The Manual key permits you to switch to manual operation. The motorized control functions of the surgical microscope are deactivated.
The lamp brightness is automatically adjusted to a fixed setting, the
value being shown in the first display section.
When the manual mode is activated, the yellow LED is lit and the word
"MANUAL" blinks in the third display section.
The surgical microscope can no longer be operated via the foot control
panel, the handgrips or the display and key field.
In the manual mode, you can only switch the illumination on and off on
the foot control panel and release the magnetic brakes by pressing the
appropriate key on the surgical microscope.
The manual mode is retained even if you turn the power switch of the
instrument off and on again.
Press the Manual key once again to reactivate electronic control; the
display in the display and key field then returns to the basic mode.
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