Zeiss OPMI Lumera T User manual

ZEISS
S88 / OPMI Lumera T
Instructions for Use
G-30-1682-en
Version 8.0
2018-11-08

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Version 8.0
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About This Manual These Instructions for Use are part of the delivery scope.
• Please read them carefully before using the device.
• Keep them at the site of use of the device.
• Store them for the entire service life of the device.
• Pass them on to any subsequent owner or user of the device.
Help with orientation – At the beginning of these Instructions for Use there is a summary of the
different sections; this provides an overview of all the the topics.
– You will also find a detailed table of contents at the beginning of each
section.
– The index facilitates searching via keywords.
Subject to change
without notice
Subject to changes in design and scope of delivery, as well as ongoing
technical development. Printed in Germany.
Scope These Instructions for Use apply to OPMI LUMERA T with the following stand
and identification:
– S88 floor stand, reference number: 305952-9940-000
Device names in
these Instructions for Use
For the purposes of clarity and improved readability, the device name
"S88 / OPMI Lumera T" has been shortened to "OPMI Lumera T" in these
Instructions for Use.
Trademark OPMI, OPMI Lumera, Superlux, Invertertube, HaMode and EDIS are
trademarks or registered trademarks of Carl Zeiss Meditec AG or another
company of the ZEISS group in Germany and/or other countries.
Manufacturer's details
Subject to changes in design and scope of delivery, as well as ongoing
technical development. Printed in Germany.
Copyright © Carl Zeiss Meditec AG 2018
All rights reserved. Reprints and reproductions, in whole or in part, are prohibited.
However, these Instructions for Use may be digitized and archived for internal
use. Access to this data by third parties is not permissible and must be prevented.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
Fax: + 49 (0) 7364 - 20 4823
Email: [email protected]
Internet: www.zeiss.com/med

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Summary of the section
Section: Safety measures 5
Section: Device overview 55
Section: Preparations for use 131
Section: Operation 165
Section: What to do in the event of malfunctions 193
Section: Care and Maintenance 211
Section: Device data 225
Section: Keyword index 251

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Safety measures
Key to symbols .................................................................................7
Hazard symbols ..........................................................................................7
Information symbols ...................................................................................7
Device names in these Instructions for Use .................................................8
Target group ....................................................................................8
Field of use .......................................................................................8
Intended use ..............................................................................................8
Normal use .................................................................................................9
Liability and warranty .......................................................................9
Notes for the operator ....................................................................10
Requirements for operation ............................................................13
Prior to the very first use ...........................................................................13
Before every use .......................................................................................14
During use ................................................................................................16
After every use .........................................................................................18
Phototoxic injury to the patient's retina ....................................................19
Stand safety equipment ............................................................................24
Symbols and labels on the device ...................................................36
Labels on the microscope .........................................................................36
Labels on S88 floor stand .........................................................................42
Labels on the connector panel of the S88 floor stand ...............................46
Additional label on the S88 floor stand (Instrument tray option) ...............48
Labels on the light sources of the suspension systems ..............................50
Labels on the control panel of the suspension systems .............................52

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S88 / OPMI Lumera T Safety measures
Key to symbols
We would like to inform you about safety requirements with which you must
comply when working with this system. This chapter contains a summary of
the most important information concerning matters relevant to instrument
safety.
Hazard symbols
The following safety information has been incorporated into the Instructions
for Use. Please note this information and be particularly careful in these cases.
Information symbols
The following information symbols are used in these Instructions for Use:
–Lists
9Requirements for an action
• Prompt for action
ÆResult of an action
Additional information and hints
WARNING Indicates a hazard which may lead to fatal injuries or severe injuries if
precautions are not followed.
CAUTION Indicates a hazard which may lead to moderately severe injuries
if precautions are not followed.
NOTE Indicates a hazard which may lead to minor injuries or property damage
if precautions are not followed.

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Device names in these Instructions for Use
For the purposes of clarity and improved readability, the device name
"S88 / OPMI Lumera T" has been shortened to "OPMI Lumera T" in these
Instructions for Use.
Target group
These instructions for use are intended for physicians, nurses and other
medical staff who prepare, operate or maintain the device after training by
ZEISS personnel. It is the duty of the device owner/operator to train and brief
all operating personnel.
Additional service activities are not part of these Instructions for Use. They will
be performed by staff specially trained for this purpose by ZEISS.
Field of use
Intended use
OPMI Lumera T is a surgical microscope intended for magnifying the surgical
area and for supporting visualization in surgical procedures in the field of
ophthalmology.

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Normal use
OPMI Lumera T was designed for surgical procedures in the field of
ophthalmology. Through its specific SCI (Stereo Coaxial Illumination) system,
various light sources (halogen, Superlux Eye xenon), the clip-on RESIGHT
fundus viewing system and its mechanical construction, it is adapted to the
ophthalmic needs of the anterior and posterior segments of the eye.
Use the protective devices offered to reduce radiation exposure in patients
with a high degree of retinal impairment. These devices include the blue
barrier filter and the retinal protection device.
Liability and warranty
The warranty and liability depend on the contractually specified conditions.
CAUTION Not for diagnostic purposes!
Do not use the recorded video sequences, video clips (cut sequences)
and single images for diagnostic purposes. Visualized images may contain
variations in shape, contrast and color.
NOTE Loss of warranty
Modifications to this device are not permitted. The manufacturer is not liable
for damages caused by an unauthorized use of the device. Furthermore,
such unauthorized modifications will render the warranty and any claims
under warranty invalid.

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Notes for the operator
The correct use of the device is absolutely vital for safe operation. Therefore,
please thoroughly familiarize yourself with the content of these Instructions
for Use before starting up the system. Please comply with the Instructions for
Use of the other system components as well. You can obtain additional
information from ZEISS Service.
•Only operate the device within the scope of its intended use.
•The device may be operated only by properly instructed and trained
persons.
It is the responsibility of the customer or institution operating the
equipment to train and instruct all staff using the equipment.
•Keep the Instructions for Use available at all times for the operating
personnel.
•Note the symbols and labels attached to the device! (See page 36).
•Use only original accessories approved by ZEISS.
Legal regulations • Check regularly that the legal regulations applicable in your country with
regard to accident prevention and work safety are being complied with.
•This device must not be modified without the manufacturer’s approval.
If the system is modified after consultation with the manufacturer,
suitable inspections and testing must be completed to ensure subsequent
safe use.
The manufacturer is not liable for damage caused by an unauthorized
modifications to the device. Furthermore, such unauthorized modifications
will render the warranty and any claims under warranty invalid.
•If required by the applicable national laws and regulations, connect the
device to the special "equivalent power supply".
Ambient conditions • Do not use the power-operated devices included in the delivery package
– in areas where there is a risk of explosion,
– or at a distance of less than 25 cm from flammable anesthetics or
volatile solvents such as alcohol, benzine or similar substances.
•Do not use or store the device in damp rooms. Do not expose the system
to dripping water, running water, gushing water, sprayed water or splashes.

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S88 / OPMI Lumera T Safety measures
•Ensure that fluids cannot enter the device.
•Ensure that the installation conditions and the use of the device meet
surgical requirements:
–Lowvibration
– Clean environment
– Avoidance of extreme mechanical stress
Electrical safety • Always switch off the device before you disconnect connect it from the
electricity network or connect it, if you will not be using it for an extended
period of time, or want to clean its surface.
•Switch off the system at the power switch if you notice any smoke, sparks
or unusual noise. In this case, do not use the device again before it has
been repaired by our Service department.
A potential equalization connector is provided on the instrument's connection
panel (see IEC60601-1). This connector can be used to connect other active
devices to the same ground potential or for redundant connection to the
protective ground.
•Do not use multiplug strips or extension cords!
•Never open the device! The device contains freely accessible live components.
If you remove the housing, you run the risk of electric shock.
•Do not touch the device if your body is electrostatically charged and the
device is not grounded.
•Please note the information on EMC (electromagnetic compatibility) in the
chapter "System data" on page 246.
Transport & Service • The system may be transported over long distances (e.g. during relocation,
return for repair, etc.) only in its original packaging or in special return
packaging. Please contact your dealer or ZEISS Service for this purpose.
•This instrument 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.
•In order to prevent any impairment of the device’s safety due to age,
wear, etc., the user must ensure that the device is subjected to the
necessary safety checks (see section "Care and maintenance").
•Modifications and repairs on this device or any equipment operated
together with this device may only be performed by ZEISS SERVICE.

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Optics and light • Never look at the sun through the binocular tube, the objective lens or an
eyepiece.
•Avoid looking directly into the light source, e.g. into the microscope
objective lens or into the light guide, in order to prevent damage to
the eye!
• Start with the lowest brightness setting and gradually increase brightness
up to the necessary and still admissible level.
•With increasing age of the light source, the actual illumination intensity
delivered at the respective setting decreases (this is a normal property of
the system).

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Requirements for operation
Prior to the very first use
A ZEISS Service representative or an expert authorized by ZEISS will install the
system. Please make sure that the following requirements continue to be met
for further operation:
9The connecting components have been properly connected. The screw
connections have been firmly tightened.
9All cables and plugs are in perfect condition, i.e. without signs of wear,
kinks or other damage.
9The voltage set on the system corresponds to the rated line voltage on the
site of installation.
9The device is connected with the power cord supplied.
9When connecting the device to a network, please make sure that the
network does not carry any hazardous voltage.
•Never place multiple connectors on the floor.
• Do not connect any additional multiple electrical outlets.
• Only connect compatible components to the system.
• Do not exceed the max permissible electrical load of multiple electrical
outlets.
• Use multiple electrical outlets only for components of the system.
WARNING The device must not be modified without any approval!
Do not modify the device without approval from the manufacturer.
If the device is modified, suitable inspections and testing must be carried out
to ensure that it can still be used safely.
The manufacturer is not liable for damages caused by an unauthorized use
of the device. Furthermore, such unauthorized modifications will render the
warranty and any claims under warranty invalid.
WARNING Danger! Electrical voltage!
• To avoid the risk of electrical shock, this device may only be connected to
a power supply network which is provided with a protective ground
conductor.

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Before every use
•When mounting accessory equipment, please make sure that the
admissible total weight of the surgical microscope is not exceeded.
(see "Maximum load" label or the section entitled "Technical Data").
•Before every use, make certain to compensate for any added weight;
this will enable the surgical microscope to maintain its balance in all
positions of the working range.
•Before every use, limit the stroke of the suspension arm to prevent any
contact with the patient if the surgical microscope is lowered accidentally.
•Check the surgical microscope for sufficient freedom of movement. The
device itself or accessories may be damaged if conflicting with each other.
•To ensure that no accessories can fall off the system, check the unit before
each use to makes sure that the accessories are firmly attached and that
the securing screws are properly tightened.
•When mounting accessories (e.g. fundus viewing systems) on the system,
make sure that sufficient free space is available for focus positioning and
that the surgical microscope cannot touch the patient.
• Before using a fundus viewing system, make sure that the space available
for movement is greater than the downward travel path of the
microscope.
•Always route cables so that they do not hinder the user.
•Before every use, switch off the light source for light guides that are not
being used and attach them on the mount provided.
•Before every use, check the light source in order to prevent phototoxic
injuries to the patient’s eye.
•If the xenon lamp is used beyond its maximum service life of 500 hours,
a sudden failure may occur. Replace the xenon lamp in due time and reset
the service hour counter to "0".
•Have an OR illuminator or an Endo-Illuminator ready during every procedure.
•Before every use, check the filter settings in order to prevent phototoxic
injuries to the patient’s eye.
•Never cover any ventilation openings. This may cause the light source of
the device to overheat and fail.

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•In the event of overheating, the lamp switches off automaticall. When the
lamp has cooled down, it switches on again automatically. The patient's
eye may be injured by the sudden high light intensity.
Activate the backup lamp immediately after the lamp failure or switch off
the illumination system.
•Never use force when trying to connect any electrical connectors
(plugs, sockets). If connection is not readily possible, check whether
the plug fits the socket. If any of the connectors are damaged,
have ZEISS Service repair them.
•Position the suspension system in such a way that you can slide or swing
it away from the patient at any time.
•Prior to using the wireless foot control panel (FCP WL), make sure that its
batteries are fully charged. Inadequate power supply to the wireless foot
control panel may cause the device to malfunction.
•Go through the checklist in the chapter "Operation".
•Depending on the application, take appropriate precautions to ensure
that the surgical procedure or treatment can be completed without the
full functionality of this microscope (e.g. illumination) if necessary.
•If you operate the device in a sterile area, make sure that you use the
corresponding sterile accessories for the device.
Sterile single-use drapes are available to cover the system.
• When draping the system, make sure there is enough slack in the drapes
to allow for movement of the microscope carrier and surgical microscope.
•Comply with the instructions for use of the sterile drape and attach the
drape in such a way that your field of view is not impaired.
•Use the grab handle on the floor stand for moving.
• Mind the maximum vertical clearance when passing through doorways.
• Avoid any jolting.
• Be extremely careful when moving over slopes.
• Do not park the device on sloped surfaces.
•Secure the system in position by locking at least three of the tabs on the
stand base to prevent the stand from rolling away inadvertently.

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During use
•Reduce the brightness and duration of light exposure of the surgical area
to the absolute minimum level required to prevent phototoxic injuries to
the patient’s eye.
•When operating on the eye, always use the retina protection filter
(blue barrier filter) installed in the light source and/or the retina protection
device in order to prevent phototoxic injuries to the patient’s eye.
•Adjust the intensity of the irradiation and the resulting irradiation time by
selecting the appropriate illumination setting in order to prevent phototoxic
injuries to the patient's eye. You'll find the values recommended by
ZEISS in the table "Maximum radiation exposure times" on page 22.
Any deviation from these values is only permissible when medically justified.
•Avoid looking directly into the light source, e.g. into the microscope
objective lens or light guide, in order to prevent phototoxic injuries to the
patient's eye.
•If the light guide is not connected at both ends, there may be a risk of fire
or burning when the illumination system is activated.
•Never leave a device unattended when its light source is switched on.
•Do not swing the assistant's microscope into the horizontal viewing
direction. Otherwise the lock might be released inadvertently and the
entire assistant's microscope might drop on the patient.
•If you have mounted the RESIGHT fundus viewing system on the underside
of the microscope and steeply tilt the microscope, the RESIGHT fundus
viewing system may unintentionally move in and injure the patient.
Remove the RESIGHT fundus viewing system before steeply tilting the
microscope.
•Defective or unidentified accessories may lead to increased leakage
current on the device and injure the patient. Never connect any defective
or unidentified accessories and never touch the power outlet or video
interfaces while in contact with the patient.
•If you replace the lamp shortly after it has failed, the lamp will still be very
hot. Use heat-resistant protective gloves when replacing the lamp to
prevent burns.
•Malfunctions in the motor's electronic system may cause the main
functions to fail (XY movement, focus, zoom) and affect other functions.
Change to manual mode.

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•In the event that the zoom function can no longer be controlled via the
foot control panel or the control panel, adjust the zoom factor manually
at the microscope.
• In the event that the focusing function can no longer be controlled via the
foot control panel or the control panel, use the suspension arm to focus
the surgical field. This may cause injury to the patient or damage to
mounted accessories. Ensure to provide sufficient clearance between
equipment and patient (min. 40 mm) when focusing manually. Ensure
that attached accessories may not come into contact with other objects.
• In the event that the X-Y movement of the surgical microscope can no
longer be controlled via the foot control panel or the control panel,
position the device manually via the suspension arm. Again, you should
ensure to provide sufficient clearance between equipment and patient
(min. 40 mm).
• In the event that the light intensity can no longer be controlled via the foot
control panel or the control panel, regulate the illumination manually at
the suspension system.
•If there is a failure and you cannot get any help from the chapter "What
to do in the event of malfunctions", attach a sign "Out of order" to the
system and contact ZEISS service representative.
•Do not pull at the light guide, power cord or any other connecting cables.
•Constantly monitor the system during use.
•Risk of crushing - mind your fingers!
Fingers may be crushed in the areas marked with the "Risk of crushing" sign.
Do not touch these areas while the device is being moved.

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After every use
•Always use the master switch to turn off the device if it is not in use.
•Insufficient, incorrect or wrong cleaning or disinfection deviating from
these Instructions for Use may lead to an infection of the patient or the
medical staff.
•Step on at least three pedals to secure the floor stand in position.
Make sure that the floor stand is stable and cannot roll away.

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Phototoxic injury to the patient's retina
Several papers1)-5) dealing with the problem of phototoxicity in ophthalmic
surgery have been published. A comprehensive review of these publications
reveals five aspects of particular concern:
– Illumination characteristics (spectral composition)
– Illumination intensity
– Angle of illumination
– Focus of the light source
– Exposure time to light
In the following, comments on these aspects are given and a description of
how ZEISS, as a manufacturer, makes allowance for them in its systems.
Illumination characteristics (spectral composition)
Studies on exposing the eye to light with varying spectral compositions have
been conducted since as early as the 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.
ZEISS offers the blue barrier filter (retina protection filter) for surgical
microscopes recommended for use in ophthalmic surgery. 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 surgeon
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.
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.

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Angle of illumination
Several publications1)-4) suggest tilting the microscope to reduce the exposure
of the macula to direct illumination.
The surgical microscope features a tilting mechanism for the main microscope
to enable indirect illumination.
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.
For this reason, 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 to light 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 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
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 setting
The brightness control scale of our systems has a linear structure with values
ranging from 0.5 through 10. The stipulations of ISO Standard 15004-2:2007
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.