S8
OPMI
®
VARIO
on S8, S81 & S88
Suspension Systems
Instructions for use
G-30-1607-en
Issue 5.0
Printed on 30. 01. 2009
2
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
Key to symbols
Different symbols used in this manual draw your attention to safety as-
pects 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 instrument.
Note:
The hand provides hints on the use of the instrument or other tips for the
user.
OPMI
®
is a registered trademark of Carl Zeiss Surgical GmbH.
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
3
Contents
– Key to symbols 2
Functions at a glance 7
– OPMI® VARIO 8
– S88 floor stand 10
– S88 floor stand with lifting column 12
– S8 ceiling mount 14
– S81 ceiling mount 16
Safety 19
– Notes on installation and use 21
– Safety devices of the suspension systems 28
– Warning labels and notes 38
Description 47
OPMI® VARIO surgical microscope 50
– Intended use 50
– Special properties 51
– Design 52
– Controls, displays, connections 54
– Binocular tubes and eyepieces 62
Xenon illumination system 66
Identical modules of the suspension systems 72
– Suspension arm 72
– Display field with control keys 74
S88 floor stand 76
– Intended use 76
– Description of the modules 77
– Design 78
– Stand base with column 80
– Connection panel 82
4
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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– Instrument tray (option) 84
– Video monitor (option) 86
S88 floor stand with lifting column 94
– Intended use 94
– Description of the modules 95
– Design 96
– Stand base with lifting column 98
– Connector panel 100
S8 ceiling mount 102
– Intended use 102
– Description of the modules 103
–Design 104
– Power switch with connector (option) 106
S81 ceiling mount 108
– Intended use 108
– Description of the modules 109
–Design 110
– Power switch, connector and socket (option) 112
VARIO surgical microscope on S88 floor stand 114
– Intended use 114
–Design 114
VARIO surgical microscope on S88 floor stand
with lifting column 116
– Intended use 116
–Design 116
VARIO surgical microscope on S8 ceiling mount 118
– Intended use 118
–Design 118
VARIO surgical microscope on S81 ceiling mount 120
– Intended use 120
–Design 120
Foot control panel (option) 122
– Intended use 122
–Design 122
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5
– Foot control panel with 14 functions 124
– Foot control panel with 8 functions 125
Preparations 127
Attaching the equipment 128
– Mounting the surgical microscope 128
– Attaching accessories 130
– Mounting the tube and eyepieces 132
Connections 134
– Connecting the surgical microscope 134
– Mounting the light guide 134
– Aligning the X-Y coupling 138
– Strain relief device on S88 floor stand 140
– Connecting the S88 floor stand 142
Adjusting the supension system 144
– S88 floor stand with lifting column -
Setting the ergonomic working height 144
– Adjusting the balance setting of the suspension arm 146
– Adjusting the limit of downward movement 148
– Positioning the S8 ceiling mount 150
Settings on the control and display panel 153
– Adjusting the suspension system 153
Balancing the surgical microscope 154
Adjusting the surgical microscope 156
Surgical microscope with a laser micromanipulator 157
Relocating the system 160
Operation 163
Checklist 164
Positioning the S88 floor stand 168
Using the display and key field 170
– General functions 170
– OPMI Vario on the suspension system, user interface
with SpeedFokus option 174
Procedure 194
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G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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What to do in an emergency 196
– Failure of a xenon lamp 196
– Failure of lamp control 200
– Failure of the zoom function 201
– Failure of the focusing function 202
– Failure of magnetic brakes 203
Maintenance / Further information 205
– Trouble-shooting 206
– Changing the xenon lamp module 214
– Adjusting the monitor arm 218
– Magnifications / Fields of view 220
– Care of the unit 222
– Sterilization 223
– Disinfecting the control keys 224
– Ordering data 226
– Spare parts 230
– Accessories 231
– Disposal 233
Technical data 235
– Technical data of OPMI VARIO 237
– Technical data of S88 floor stand 238
– Technical data of S88 floor stand with lifting column 240
– Technical data of S8 ceiling mount 246
– Technical data of S81 ceiling mount 250
– Ambient requirements 253
– CE conformity 253
– Changes to the system 253
Index 255
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
Functions at a glance 7
Functions at a glance
OPMI® VARIO 8
S88 floor stand 10
S88 floor stand with lifting column 12
S8 ceiling mount 14
S81 ceiling mount 16
8 Functions at a glance
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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OPMI
®
VARIO
1 Adjusting the eyecup and the prescription page 64
2 Adjusting the interpupillary distance page 62
3 Adjusting the friction of vertical adjustment page 54
4 Recentering the X-Y coupling page 60
5 Adjusting the friction of the OPMI® axis of rotation page 60
6 Manual zoom setting page 56
7 Manual focusing page 56
8 Manual setting of the illuminated field diameter page 56
9 Connecting the light guide page 134
10 Balance setting of the microscope's
front-to-back tilt
page 54
11 Balance setting of the microscope's
lateral tilt
page 54
12 Motorized focusing page 58
13 Motorized zoom setting page 58
14 Display of the magnification factor of
the zoom system
page 54
15 Releasing the magnetic brakes page 58
16 Programmable release buttons page 58
17 Switching off the electrical drive of the
focusing system
page 56
18 Connecting the mouth switch page 54
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Functions at a glance 9
5
186
1 23 4
78 11 12 13 14 15 16 17910
10 Functions at a glance
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
S88 floor stand
1 Control panel page 70
2 Illumination system page 66
3 Releasing the magnetic brakes of the suspension
system
page 72
4 Limiting the suspension arm's downward movement page 72
5 Removing/mounting the coupling for the
surgical microscope
page 72
6 Balance setting page 72
7 Locking the stand in position page 80
8 Locking the suspension arm in its horizontal position page 72
9 Connecting the foot control panel or hand switch,
plugging in the remote control connector
page 82
10 Rated voltage display page 82
11 Connector panel page 82
12 Switching on the suspension system page 82
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Functions at a glance 11
12 43
56
7 4 8910,11,12
12 Functions at a glance
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
S88 floor stand with lifting column
Xenon illumination system
1 Selecting a filter page 68
2 Manual activation of backup bulb page 66
3 Resetting the counter page 68
4 Opening the lamp module page 68
5 Red segment is lit - backup bulb is in use page 66
6 Control panel
7 Lamp housing of xenon illumination system page 66
8 Unlocking the magnetic brakes of the suspension
system
page 72
9 Limiting the suspension arm's downward movement
10 Removing/mounting the coupling for the
surgical microscope
page 72
11 Balance setting
12 Locking the stand in position page 80
13 Raising/lowering the lifting column page 144
14 Locking the suspension arm in its horizontal position page 72
15 Connecting the foot control panel or hand switch,
Connecting the remote control connector
page 82
16 Rated voltage display page 82
17 Connector panel page 82
18 Turning on the suspension system page 82
421 53
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Functions at a glance 13
67 98
10 11
12 13 9 14 15 16, 17, 18
14 Functions at a glance
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
S8 ceiling mount
1 Locking the suspension arm in its horizontal position page 72
2 Releasing the magnetic brakes of the suspension system page 72
3 Balance setting page 72
4 Illumination system page 66
5 Control panel (rotatable through 180° or 70°) page 70
6 Connecting the foot control panel or hand switch,
plugging in the remote control connector
page 106
7 Switching on the suspension system page 106
8 Releasing - moving - locking the lift arm page 104
9 Removing/mounting the coupling for the
surgical microscope
page 72
10 Setting the limit of downward travel page 72
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Functions at a glance 15
102798
1
5623 4
16 Functions at a glance
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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S81 ceiling mount
1 Locking the suspension arm in its horizontal position page 72
2 Releasing the magnetic brakes of the suspension system page 72
3 Balance setting page 72
4 Illumination system page 66
5 Control panel (rotatable through 180° or 70°) page 70
6 Option: hand control panel socket for ceiling track mount page 112
7 Plugging in the remote control connector page 112
8 Connecting the foot control panel or hand switch page 112
9 Switching on the suspension system page 112
10 Removing/mounting the coupling for the
surgical microscope
page 72
11 Setting the limit of downward travel page 72
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Functions at a glance 17
10 112
9
456123 87
18 Functions at a glance
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Safety 19
Safety
Notes on installation and use 21
Safety devices of the suspension systems 28
Warning labels and notes 38
20 Safety
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
The device described in this manual has been designed and tested in ac-
cordance with Carl Zeiss safety standards as well as German and inter-
national standards. This guarantees a high degree of instrument safety.
The system described in this user manual has been designed in compli-
ance with the requirements of:
In accordance with Directive 93/42/EEC for medical devices, the com-
plete quality management system of the company Carl Zeiss Surgical
GmbH, 73446 Oberkochen, Germany, has been certified by DQS Deut-
sche 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 start-
up of the instrument. Please also observe the user manuals of any addi-
tional equipment. Further information is available from our service depart-
ment 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 ap-
ply in your country.
–EN –IEC –UL –CSA
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Safety 21
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 poten-
tial equalization measures. For this purpose, contact our service de-
partment.
• Do not use a mobile phone in the vicinity of the equipment because
the radio interference can cause the equipment to malfunction. The ef-
fects 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 for-
feit any rights to claim under warranty.
• Over longer distances (e.g. removal, return for repair, etc), the instru-
ment 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.
22 Safety
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
• 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 al-
lowed 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 opti-
mum 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 main-
tenance 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 con-
tact 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 func-
tion.
The system complies with the limits for a Class A device concerning radio
frequency emission. However, the possibility of interference to high fre-
quency receiving devices (e.g. TV sets or radios) being used in the sur-
roundings cannot be ruled out. If interference of this type occurs, please
inform your Carl Zeiss Service.
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Safety 23
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 re-
quirements (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.
24 Safety
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
Connection of navigation systems (option)
The Carl Zeiss components "Surgical microscope on suspension system"
can be integrated into an external navigation system. An optional naviga-
tion 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
certified for operation with the respective Carl Zeiss surgical micro-
scope on a suspension system in accordance with the require-
ments specified in the Carl Zeiss interface description "Navigation
Interface for Carl Zeiss Surgical Microscopes".
– Meeting all requirements (approval, qualifications, etc.) for the
medical system created through coupling via the navigation inter-
face.
– Provision of all accompanying documents required.
– 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 sys-
tem" 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 in-
stallation 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 sys-
tem, 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 ster-
eotactic data has been correctly generated and transmitted to the nav-
igation system without errors.
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Safety 25
• Do not use any rotatable tube dovetail mounts when operating the sur-
gical 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 surgi-
cal microscope on a suspension system in accordance with the re-
quirements 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-to-
face 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 precau-
tions.
26 Safety
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
Printed on 30. 01. 2009
Requirements for operation
• For ceiling mounts only: Our service staff or a qualified person ap-
pointed by us will install the system on ceiling anchors which have
been properly mounted by the construction engineers responsible.
These ceiling anchors must comply with the specifications contained
in our planning manual.
• Our service representative or an expert authorized by us will install the
system. Please ensure that the following requirements are met for fur-
ther operation:
– All connecting components (details in the user's manual) which are
relevant to system safety have been properly connected, and the
screw connections have been firmly tightened.
– All cables and plugs are in perfect condition.
– The voltage set on the instrument corresponds to the rated line
voltage on the site of installation.
– The power cord has been plugged into a power outlet which has a
properly connected protective ground contact.
– The power cord being used is the one designed for use with this
system.
Before every use and after re-equipping the instrument
• Make sure that all ”Requirements for operation” are fulfilled.
• Go through the checklist.
• Re-attach or close any covers, panels or caps which have been re-
moved 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 ob-
jective 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.
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Safety 27
• Make sure that the instrument has been switched off before you
change the xenon lamp module. When switched on, the ignition sys-
tem 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:
– 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.
• Since the xenon lamp provides high light intensity and generates light
with a spectrum similar to daylight, it must not be used for ophthalmic
applications.
• 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.
S88 floor stand
• 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.
28 Safety
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Safety devices of the suspension systems
1 Release bar
Allows non-sterile persons to release the magnetic brakes of the sus-
pension system.
2 Adjustment 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
each surgical proce-
dure.
3 Locking 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 up-
ward when insufficient weight is attached. After attaching a unit, per-
form the balancing procedure.
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Safety 29
1
1
2
3
30 Safety
G-30-1607-en OPMI® VARIO on S8, S81 & S88 Suspension Systems Issue 5.0
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Stand lifting column
1 Key
to set the optimum viewing height of the surgical microscope or for
downward movement into the transport position.
As long as you keep switch (1) pressed down, the lifting column (2) in
the stand base moves upwards or downwards, depending on the po-
sition of the switch. When you release the switch, the lifting column
stops immediately.
– Before raising or lowering the suspension system, make sure that
there is sufficient clearance from other objects so that any collision is
avoided.
Warning!
– Do not
activate the lifting column during surgery!
– Do not
use the lifting column for focusing.
– When using the fundus imaging system which is installed between the
surgical microscope and the patient, make sure that the patient is nei-
ther put at risk nor injured
– by the motorized movement of the lifting column,
– by the motorized focusing system,
– by the movement of the suspension arm.
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