Zeiss OPMI Vario User manual

OPMI Vario®
Retrolux®System
Instructions for use
G-30-1721-en
Issue 1.0
Printed on 12. 03. 2008

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G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
Printed on 12. 03. 2008
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 system.
Note:
The hand indicates hints on the use of the system or other tips for the
user.
OPMI®and Retrolux®are registered trademarks of Carl Zeiss Surgical
GmbH.

G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
Printed on 12. 03. 2008
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Contents
– 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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– 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
– 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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G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
Printed on 12. 03. 2008
Functions at a glance 7
Functions at a glance
OPMI® VARIO 8
S88 floor stand 10

8Functions at a glance
G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
Printed on 12. 03. 2008
OPMI®VARIO
1 Adjusting the eyecup and the prescription page 52
2 Adjusting the interpupillary distance page 50
3 Adjusting the friction of vertical adjustment page 42
4 Recentering the X-Y coupling page 48
5 Adjusting the friction of the OPMI® axis of rotation page 48
6 Manual zoom setting page 44
7 Manual focusing page 44
8 Manual setting of the illuminated field diameter page 44
9 Connecting the light guide page 104
10 Balance setting of the microscope's
front-to-back tilt
page 42
11 Balance setting of the microscope's
lateral tilt
page 42
12 Motorized focusing page 46
13 Motorized zoom setting page 46
14 Display of the magnification factor of
the zoom system
page 42
15 Releasing the magnetic brakes page 46
16 Programmable release buttons page 46
17 Switching off the electrical drive of the
focusing system
page 44
18 Connecting the mouth switch page 42

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Functions at a glance 9
5
186
123 4
78 11 12 13 14 15 16 17910

10 Functions at a glance
G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
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S88 floor stand
Xenon illumination system
1 Selecting a filter page 64
2 Manual activation of backup lamp page 62
3 Resetting the counter page 64
4 Opening the lamp module page 64
5 Red segment is lit - backup lamp is in use page 62
6 Control panel page 66
7 Lamp housing of xenon illumination system page 62
8 Unlocking the magnetic brakes of the suspension
system
page 68
9 Limiting the suspension arm's downward movement page 116
10 Removing/mounting the coupling for the
surgical microscope
page 68
11 Balance setting page 68
12 Locking the stand in position page 70
13 Locking the suspension arm in its horizontal position page 68
14 Connecting the foot control panel or hand switch,
connecting the remote control connector
page 72
15 Rated voltage display page 72
16 Connector panel page 72
17 Turning on the suspension system page 72
421 53

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Functions at a glance 11
67 9810 11
12 9 13 14 15, 16, 17

12 Functions at a glance
G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
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G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
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Safety 13
Safety
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

14 Safety
G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
Printed on 12. 03. 2008
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

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Safety 15
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.

16 Safety
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• 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.

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Safety 17
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.

18 Safety
G-30-1721-en OPMI® VARIO Retrolux System Issue 1.0
Printed on 12. 03. 2008
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.

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Safety 19
• 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.
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 fur-
ther operation:

20 Safety
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– 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.
• 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: