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
, Lumera®, Superlux®, Invertertube® and HaMode® are regis-
tered trademarks of Carl Zeiss Surgical GmbH.
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Contents
–Key to symbols 2
Functions at a glance 7
–OPMI Lumera T with integrated assistant's microscope 8
–OPMI Lumera T (option) 9
–Light sources 10
–S88 floor stand 12
–S8 ceiling mount 14
–S81 ceiling mount 16
Safety 19
–Notes on installation and use 21
–When using a wide-angle observation system (e.g. BIOM 3) 25
–Phototoxic retinal injury in eye surgery 25
–Safety devices of the suspension systems 32
–Warning labels and notes 44
Description 51
Lumera T surgical microscope 54
–Intended use 54
–Description of components 54
–Illumination system 60
–Controls, displays, connections 64
–Binocular tubes and eyepieces 72
Light sources 78
–Halogen light source (option) 80
–Superlux Eye light source 84
–Superlux Eye with integrated halogen light source (option) 92
Identical components of the suspension systems 98
–Suspension arm 98
–Display field with control keys 100
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S88 floor stand 102
–Intended use 102
–Description of components 103
–Design 104
–Stand base with column 106
–Connection panel 108
–Instrument tray (option) 110
–Video monitor (option) 112
S8 ceiling mount 120
–Intended use 120
–Description of components 121
–Design 122
–Power switch with connector (option) 124
S81 ceiling mount 126
–Intended use 126
–Description of components 127
–Design 128
–Power switch, connector and socket (option) 130
OPMI Lumera T with integrated assistant's microscope
on S88 floor stand 132
–Intended use 132
–Design 132
OPMI Lumera T with integrated assistant's microscope
on S8 ceiling mount 134
–Intended use 134
–Design 134
OPMI Lumera T with integrated assistant's microscope
on S81 ceiling mount 136
–Intended use 136
–Design 136
Foot control panel 138
–Intended use 138
–Design 138
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Preparations 143
Attaching the equipment 144
–Mounting the surgical microscope 144
–Mounting the tube, the eyepieces and the objective lens 148
–Changing the microscope accessories 152
Connections 154
–Connecting the surgical microscope 154
–Connecting the light guide 154
–Strain relief device on S88 floor stand 158
–Connecting the S88 floor stand 160
–Relocating the system 162
Adjusting the supension system 164
–Adjusting the balance setting of the suspension arm 164
–Adjusting the limit of downward movement 166
–Positioning the S8 ceiling mount 168
Settings on the control and display panel 170
–Setting up the suspension system 170
Adjusting the surgical microscope 171
–Optimizing the red reflex 172
–Adjusting the tilt angle 174
Preparing the system for sterile use 176
Operation 179
Checklist 180
–When using a wide-angle observation system (e.g. BIOM 3) 183
Positioning the S88 floor stand 184
Using the display and key field 186
–General functions 186
–Operating the OPMI® on the suspension system 190
Procedure 203
What to do in the event of malfunctions 205
What to do in an emergency 206
–Lamp failure of the halogen light source 206
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–Lamp failure in the Superlux Eye light source 208
–Failure of lamp control 212
–Failure of the focusing function 212
–Failure of magnetic brakes 214
–Failure of the X-Y coupling 214
–Failure of the zoom function 215
Causes of malfunctions and remedies 216
–Malfunctions in the surgical microscope 216
–Malfunctions in the surgical microscope with integrated
assistant's microscope 218
–Malfunctions in the S8, S81 or S88 suspension system 219
–Malfunctions in the video monitor 221
–Malfunctions in the halogen light source 223
–Malfunctions in Superlux Eye light source 224
Care and maintenance 227
–Care of the unit 228
–Sterilization 229
–Disinfecting the control keys 230
–Changing the halogen lamp 232
–Changing the Superlux Eye xenon lamp module 234
–Balancing the monitor arm 236
System data 239
–Technical data 240
–Magnifications / Fields of view 256
–Ordering data 257
–Spare parts 259
–Disposal 260
–Ambient requirements 261
–CE conformity 261
–Changes to the system 261
Index 263
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Functions at a glance7
Functions at a glance
OPMI Lumera T with integrated assistant's microscope 8
OPMI Lumera T (option) 9
Light sources 10
S88 floor stand 12
S8 ceiling mount 14
S81 ceiling mount 16
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8Functions at a glance
1
2
3
4
5
6
910127141311
5
7
341516 178
OPMI Lumera T with integrated assistant's microscope
1Resetting X-Y coupling and focus to their initial positions page 64
2Adjusting the interpupillary distancepage 72
3Adjusting the eyecupspage 76
4Setting your prescriptionpage 76
5Unlocking the magnetic brakespage 66
6Display of the zoom system's magnification factorpage 66
7Changing the magnification of assistant's microscopepage 70
8Setting the inverter functionpage 70
9Focusing the assistant's microscopepage 70
10 Tilting the surgical microscopepage 174
11 Arrows indicating the focusing rangepage 64
12 Locking screw for assistant's microscope (vertical)page 70
13 Zoom adjustment (manual emergency operation)page 215
14 Adjusting knob for different types of illuminationpage 68
15 Connecting the light guidepage 154
16 Locking screw for assistant's microscope (horizontal)page 174
17 Setting the depth of field (DeepView)page 68
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Functions at a glance9
1
2
3
4
5
6
8
10
7
1211
9
5
2
OPMI Lumera T (option)
1Resetting X-Y coupling and focus to their initial positions page 64
2Tilting the surgical microscopepage 174
3Adjusting the eyecupspage 76
4Setting your prescriptionpage 76
5Unlocking the magnetic brakespage 66
6Display of the zoom system's magnification factorpage 66
7Setting the depth of field (DeepView)page 68
8Setting the illuminationpage 62
9Arrows indicating the focusing rangepage 64
10 Adjusting the interpupillary distancepage 72
11 Zoom adjustment (manual emergency operation)page 215
12 Connecting the light guidepage 154
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10Functions at a glance
1243
568
7
9
Light sources
Halogen light source
1- Closed flap: main lamp is on
- Open flap: backup lamp is on
2Selecting a filterpage 80
3Opening the lamp modulepage 80
4Manual activation of backup lamppage 80
Superlux Eye light source
5Selecting a filterpage 84
6Resetting the counterpage 88
7Opening the lamp modulepage 84
8Manual activation of backup lamppage 84
9Red segment is lit - backup lamp is in usepage 84
page 80
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Functions at a glance11
245678 913
Superlux Eye light source with
integrated halogen light source (option)
1Selecting the filter for Superlux Eye light sourcepage 93
2Switching manually to the backup lamp of
page 93
Superlux Eye light source
3Resetting the counterpage 38
4Opening the Superlux Eye lamp modulepage 80
5Additional integrated halogen light source:
page 94
- Closed flap: main lamp is on
- Open flap: backup lamp is on
6Selecting the filter for additional integrated halogen
page 94
light source
7Opening the lamp module of integrated halogen
page 94
light source
8Manual activation of the halogen light source's
page 94
backup lamp
9Superlux Eye light source:
page 94
red segment is lit - backup lamp is in use
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12Functions at a glance
S88 floor stand
1Control unitpage 186
2Light sourcepage 78
3Unlocking the magnetic brakes of the suspension
system
4Limiting the suspension arm's downward movement page 166
5Removing/mounting the coupling for the
surgical microscope
6Balancing the suspension armpage 164
7Locking the stand in positionpage 106
8Locking the suspension arm in its horizontal position page 98
9Connecting the foot control panel,
connecting the remote control connector
10 Rated voltage displaypage 108
11 Connector panelpage 108
12 Switching on the suspension systempage 108
page 98
page 98
page 108
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Functions at a glance13
1243
56
748910,11,12
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14Functions at a glance
S8 ceiling mount
1Locking the suspension arm in its horizontal positionpage 98
2Unlocking the magnetic brakes of the suspension
system
3Balancing the suspension armpage 164
4Light sourcepage 78
5Control unit (rotatable through 180° or 70°)page 186
6Connecting the foot control panel,
connecting the remote control connector
7Switching on the suspension systempage 124
8Releasing - moving - locking the lift armpage 122
9Removing/mounting the coupling for the
surgical microscope
10 Limiting the suspension arm's downward movementpage 166
page 98
page 124
page 98
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Functions at a glance15
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1
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16Functions at a glance
S81 ceiling mount
1Locking the suspension arm in its horizontal positionpage 98
2Unlocking the magnetic brakes of the suspension
system
3Balancing the suspension armpage 164
4Light sourcepage 78
5Control unit (rotatable through 180° or 70°)page 186
6Connecting the foot control panel if the suspension
system is installed on a ceiling track mount (option)
7Connecting the remote control connectorpage 130
8Connecting the foot control panelpage 130
9Switching on the suspension systempage 130
10 Removing/mounting the coupling for the
surgical microscope
11 Limiting the suspension arm's downward movementpage 166
page 98
page 130
page 98
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Functions at a glance17
10112
9
45612387
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18Functions at a glance
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Safety
Safety19
Notes on installation and use 21
When using a wide-angle observation system (e.g. BIOM 3) 25
Phototoxic retinal injury in eye surgery 25
Safety devices of the suspension systems 32
Warning labels and notes 44
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20Safety
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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Safety21
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: If requested, the instrument can be incorporated into potential equalization measures.
•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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22Safety
•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.
•When mounting accessory equipment, please make sure that the admissible total weight of the surgical microscope is not exceeded. (See
label or chapter "Technical data").
•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 system is a high-grade technological product. To ensure optimum
performance and safe working order, we recommend having it checked
by our service representative as part of regular scheduled maintenance.
If a failure occurs which you cannot correct with the aid of the chapter
"What to do in the event of malfunctions“, attach a sign to the system
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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Safety23
Requirements for operation
•For ceiling mounts only: Our service staff or a qualified person appointed 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 further operation:
–All mechanical connections (details in the user's manual) which are
relevant to safety are properly connected and screw connections tightened.
–All cables and plugs are in good working condition.
–The voltage setting on the instrument conforms to the rated voltage of
the line supply on site.
–The instrument is 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 in-
strument.
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 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.
•Excessive radiation exposure times may lead to retinal injury in the patient's eye. Never leave a system unattended when the light source
has been activated.
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24Safety
•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.
Xenon lamps feature high luminance and a spectrum resembling that of
natural daylight. Therefore, only special xenon lamps approved by Carl
Zeiss must be used in ophthalmology.
•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.
•Phototoxic effect of light beams. When operating on the eye, always
use the yellow protection filter to ensure that the patient's eye is not
exposed to unnecessary (blue) radiation (risk of retinal injury).
•Adjust the illumination intensity as required for the type of illumination
used and the radiation exposure time. You will find the values recommended by Carl Zeiss in the table "Maximum radiation exposure
times" on page 29.
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.
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Safety25
1
2
Risk of collision!
When using a wide-angle observation system (e.g. BIOM 3)
When using a wide-angle observation system (e.g. BIOM 3 from Oculus)
which is usually installed between the surgical microscope and the patient, make sure that the patient is neither put at risk nor injured by the motorized focusing system or the movement of the suspension system arm.
Only use accessories expressly certified by the manufacturer for combination with the surgical microscopes described in this manual.
Warning!
•With the wide-angle observation system swung out of position, always
position the microscope body in such a way that index dot (1) of the
microscope's focus is in the middle of triangle (2) of the marking.
•Select a medium magnification (e.g. 1.0).
•Lower the surgical microscope toward the surgical field until you see
the patient's cornea sharply defined.
•Turn the setting screw for limiting the downward movement clockwise
as far as it will go and check without the patient that the suspension
arm cannot be lowered any further.
It is vital that you read the user manual for the wide-angle observation
system used (e.g. BIOM 3 from Oculus).
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.
For protection of the retina, Carl Zeiss offers the blue barrier filter (retina
protection filter) as a standard feature of the OPMI Lumera surgical microscopes. This reduces not only the exposure of the patient's eye to light,
but also that of the surgeon's.
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
–Surrounding field illumination with brightness control
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
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 also recommended 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 microscope's illumination beam path
and a blue barrier filter (retina protection filter).
Brightness control
The brightness control scale of our systems has a linear structure with
values ranging from 0.5 to 10. The stipulations of standard ISO/FDIS
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 as 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
than longer wavelengths).
–Duration of direct exposure.
–Pupil size.
–Clarity of ocular media (infants and young children, for example,
may be at a higher risk).
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28Safety
–Phakic status of the eye (aphakic and pseudo-aphakic eyes with-
–Previous exposure to bright light such as retinal photography, es-
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 recommended occupational health daily exposure limits as defined in
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 photoretinitis might be expected to occur.
A prospective study
gery 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.
out UV and blue filtering IOLs are at a higher risk).
pecially within the last 24 hrs.
7)
of the effects of microscope illumination during sur-
6)
. A
The red reflex illumination (stereo coaxial illumination) of OPMI Lumera
has been designed to provide a bright red reflex using only very small
quantities of light at the center of the light spot. The peripheral field illumination causes higher exposure of the retina, but usually not directly of the
macula, depending on the position of the eye. For cataract procedures,
we recommend adjusting the surrounding field illumination to be somewhat darker than the central red reflex spot. Not only does this setting
minimize phototoxic risk, but it also reduces glare from the patient's
sclera.
Other recommendations for minimizing phototoxic risk are:
•Always use the lowest possible brightness setting.
•Use the blue barrier filter (retina protection filter) to block the blue
spectrum of light. The blue barrier filter will increase the recommended
exposure times by factor three.
•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.
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Safety29
Maximum radiation exposure times
The use of the blue barrier filter (retina protection filter) increases the recommended exposure time by a factor of 3 compared with the values specified below.
Red reflex illumination (stereo coaxial illumination)
Scale display
of Illumination
Max. exposure time in minutes
HalogenXenonXenon with
HaMode filter
2.5508.228
5214.216.5
7.5132.910.3
1092.28.5
Surrounding field illumination
Scale display
of Illumination
Max. exposure time in minutes
HalogenXenonXenon with
HaMode filter
2.58.72.58.9
53.71.35.2
7.52.20.93.3
101.60.72.7
Note:
The illumination system of the surgical microscope contains a UV
blocking filter as a standard feature.
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
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).
G-30-1682-en OPMI® Lumera® T Issue 4.0
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30Safety
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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