Zeiss OPMI Lumera i on floor stand User manual

ZEISS
OPMI Lumera®i
on floor stand
Instructions for use
G-30-1720-en
Version 9.2
2020-10-06

OPMI Lumera®i on floor stand
Version 9.2
Page 2 G-30-1720-en
About this manual These instructions for use are part of the delivery scope.
•Carefully read them before you use the device.
•Keep them where you use the device.
•Store them for the entire service life of the device.
•Pass them on to any subsequent owner or user of the device.
Orientation aids – At the beginning of these instructions for use, there is a summary of the
different sections; this provides an overview of all the topics.
– The contents of each chapter are specified in detail at the beginning of
each section.
– A list of abbreviations, key words, and technical terms in the annex facili-
tates the search for specific terms.
Scope These instructions for use apply to OPMI Lumera i with the following identifi-
cation:
– Reference number: 6633
– Software release 1.5.1
Trademark OPMI, OPMI Lumera, Invertertube, CALLISTO eye, HaMode SCI (Stereo
Coaxial Illumination), MindStream, 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 change in design and scope of delivery as well as technical devel-
opment. Printed in Germany.
Copyright © Carl Zeiss Meditec AG 2020
All rights reserved. Reprints and reproductions, in whole or in part, are prohib-
ited. However, these instructions for use may be digitized and archived for
internal use. Access to these data by third parties is not permissible and must
be prevented.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
E-mail: [email protected]
Internet: www.zeiss.com/med

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Table of contents
Safety measures
Key to symbols ................................................................................11
Hazard symbols .........................................................................................11
Information symbols..................................................................................11
Target audience...............................................................................12
Intended field of application............................................................12
Intended use .............................................................................................12
Indications.................................................................................................13
Normal use................................................................................................13
Notes for the operator.....................................................................15
Duties of the operator ...............................................................................15
Requirements to be met by the user ..........................................................18
Liability and warranty ................................................................................18
Requirements for operation.............................................................20
Before every use........................................................................................20
During use.................................................................................................21
After every use ..........................................................................................21
Measures to prevent phototoxic injury ............................................22
Illumination characteristics (spectral composition)......................................22
Illumination intensity .................................................................................23
Angle of illumination .................................................................................23
Focus of the light source ...........................................................................23
Duration of exposure to light.....................................................................24

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Safety features.................................................................................28
Button for backup lamp............................................................................ 28
Filter wheel for protection filter ................................................................ 28
Switch for the manual mode..................................................................... 30
Locking lever for limiting vertical movement ............................................. 32
Position of the microscope with fundus viewing system............................ 32
Symbols and labels on the device ....................................................34
Overview of devices
System overview..............................................................................40
Components of the microscope .......................................................42
Controls on the microscope ...................................................................... 44
Control elements of the tubes................................................................... 48
Control elements of the widefield eyepieces ............................................. 49
Components of the stand ................................................................50
Control elements on the suspension arm .................................................. 51
Control elements on the carrier arm, stand column, stand base ................ 52
Control elements on the lamp housing ..................................................... 53
Connector panel on the floor stand .......................................................... 54
Control elements on the control and display panel.................................... 56
Components of the foot control panel.............................................57
Accessories for documentation and co-observation.........................59
EDIS – External Data Injection System (optional) .............................61
1Chip HD Camera (optional) ............................................................62

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Preparations for use
Relocating the device ......................................................................66
Configuring surgical microscope......................................................68
Changing tubes, eyepieces, or objective lens .............................................68
Mounting video and documentation accessories .......................................70
Connecting light guide to surgical microscope...........................................76
Balancing system.......................................................................................77
1Chip HD Camera option .................................................................78
Installing the 1Chip HD Camera.................................................................78
Cable connections for the 1Chip HD Camera .............................................79
Connecting system and accessories .................................................80
Connecting the stand to the power supply ................................................80
Connecting the foot control panel to the stand .........................................81
Connecting the strain relief device.............................................................82
Connecting video devices (option) .............................................................83
Setting up the system......................................................................84
Limiting downward movement of the suspension arm...............................84
Positioning the device in the OR ................................................................85
Adjusting the tilting...................................................................................86
Adjusting the surgical microscope .............................................................87
Preparing device for sterile use .......................................................89
Asepsis Caps..............................................................................................89
Drapes.......................................................................................................90
Operation
Powering system up/down ..............................................................93
Functional test before use ...............................................................95

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Menu structure ..............................................................................100
Controls on the 5.7″control panel with touchscreen functionality .......... 102
Managing user data.......................................................................104
Creating new user................................................................................... 104
Selecting users ........................................................................................ 105
Changing user name............................................................................... 105
Setting language..................................................................................... 106
Deleting users ......................................................................................... 106
Setting light source........................................................................107
Switching light source on/off .................................................................. 107
Setting start value of light source............................................................ 109
Setting magnification ....................................................................110
Setting start value of zoom system.......................................................... 110
Display of overall magnification .............................................................. 111
Zoom/focus link ...................................................................................... 111
Configuring foot control panel ......................................................112
Preconfigured button assignment ........................................................... 112
Changing button assignment.................................................................. 113
System settings..............................................................................114
Configure XY reset button ...................................................................... 114
Configuring parking position................................................................... 115
Setting speeds ........................................................................................ 116
Setting parameters for overall magnification........................................... 117
System information................................................................................. 117
Pairing with wireless foot control panel .................................................. 117
Typical procedure ..........................................................................119

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What to do in the event of malfunctions
Failure of the halogen light source ................................................124
Failure of a main function (XY, focus, zoom, light) ........................125
Troubleshooting ............................................................................126
For your safety ........................................................................................126
System malfunctions................................................................................126
Malfunctions of the FCP foot control panel..............................................129
Error messages on the 5.7″control panel ................................................129
Care and maintenance
System maintenance......................................................................132
Maintenance intervals..............................................................................132
Safety check ............................................................................................133
Changing the halogen lamp ...................................................................134
Care of the device..........................................................................136
Cleaning ..................................................................................................136
Sterilization .............................................................................................137
Disinfection .............................................................................................137
Environmental protection measures ..............................................138
Note on disposal .....................................................................................138
Device data
Technical data ...............................................................................140
Essential performance features OPMI Lumera i ........................................140
Accessories..............................................................................................145
Guidelines and manufacturer’s declaration for electromagnetic
compatibility..................................................................................148

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EMC - Electromagnetic compatibility
IEC 60601-1-2: 2014 (4th edition)..................................................150
Electromagnetic interference .................................................................. 150
Electromagnetic immunity for all ME equipment and systems ................. 151
Electromagnetic immunity for ME equipment or systems that are not
life-sustaining ......................................................................................... 152
System combinations.....................................................................153
Accessories and components .........................................................154
Components for surgical microscope ...................................................... 155
Other accessories.................................................................................... 155
Regulatory information..................................................................164
Ambient conditions........................................................................165
Indexes
Index of technical terms ................................................................167
List of abbreviations ......................................................................167
Index..............................................................................................169

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Safety measures
Key to symbols ................................................................................11
Hazard symbols .........................................................................................11
Information symbols..................................................................................11
Target audience...............................................................................12
Intended field of application............................................................12
Intended use .............................................................................................12
Indications.................................................................................................13
Normal use................................................................................................13
Notes for the operator.....................................................................15
Duties of the operator ...............................................................................15
Requirements to be met by the user ..........................................................18
Liability and warranty ................................................................................18
Requirements for operation.............................................................20
Before every use........................................................................................20
During use.................................................................................................21
After every use ..........................................................................................21
Measures to prevent phototoxic injury ............................................22
Illumination characteristics (spectral composition)......................................22
Illumination intensity .................................................................................23
Angle of illumination .................................................................................23
Focus of the light source ...........................................................................23
Duration of exposure to light.....................................................................24

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Safety features.................................................................................28
Button for backup lamp............................................................................ 28
Filter wheel for protection filter ................................................................ 28
Switch for the manual mode..................................................................... 30
Locking lever for limiting vertical movement ............................................. 32
Position of the microscope with fundus viewing system............................ 32
Symbols and labels on the device ....................................................34

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Key to symbols
We would like to inform you of the safety aspects that must be observed
when handling this device. 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
Requirement for an action
•Prompt for an action
Result of an action
Additional information and tips.
These do not contain any warnings of hazards.
WARNING Indicates a hazard which may lead to severe or fatal injuries if precautions
are not followed.
CAUTION Identifies a hazard which may lead to slight or moderate injuries if precau-
tions are not followed.
NOTICE Identifies a hazard which may lead to material damage if precautions are
not followed.

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Safety measures OPMI Lumera®i on floor stand
Target audience
These instructions for use are intended for physicians, nurses, and other
medical and technical staff who prepare, operate, or maintain the device after
training by ZEISS personnel. The operator must ensure that the personnel
working with the system possess the necessary qualifications and training.
Additional service activities are not part of these instructions for use. They will
be performed by staff specially trained for this purpose by ZEISS.
Intended field of application
Intended use
OPMI Lumera i is a surgical microscope intended for the illumination and
magnification of the surgical area and for the support of visualization in
surgical procedures in the field of ophthalmology.

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Indications
Information on the intended medical indications for use, contraindications,
and the target patient group has been set out in the following table.
Normal use
OPMI Lumera i is intended exclusively for ophthalmic surgical procedures.
With its specific illumination system SCI (Stereo Coaxial Illumination), halogen
light sources, the attachable fundus viewing system RESIGHT, and its mechan-
ical design, it is tailored to suit the requirements of surgery on the front and
side of the eye.
Preparing floor stands
The four casters enable the floor stand to be moved easily from one position
to another, and the flexible arms allow the surgeon to adopt an ergonomic
position during the operation.
Preparation
After switching on the power button, you can move the system safely and
smoothly into the working position.
Intended medical indications for use
Medical discipline: Ophthalmology
Indication: OPMI Lumera i is intended exclusively for ophthalmic
surgical procedures performed on the eye. It illuminates
and magnifies the structures of the eye (intraocular,
extraocular) during a surgical procedure.
All types of surgical procedure on the anterior and
posterior segments of the eye can be performed for a
number of different applications, e.g. cataracts, glau-
coma, diseases of the retina, diseases of the cornea,
vitrectomy, etc.
Contraindication: When using OPMI Lumera i within its indication of
use, there are no known contraindications.
Patient target
group
Age: No restriction
Gender: All

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Before the start of the surgery, a sterile person covers the microscope or
applies resterilizable caps.
Surgery
The surgeon or a sterile person positions the microscope and roughly focuses
it. During surgery, the most common functions, e.g. focus, zoom, XY move-
ment, light intensity up/down, are mainly operated by the surgeon using the
foot control, enabling hands-free surgical intervention. Some settings, e.g.
illumination ratio (SCI), movement of microscope, or insertion of RESIGHT for
surgery on the posterior segment of the eye, are made manually. For training
purposes or to show employees the steps involved in the surgical workflow,
a video cable can be connected to the system.
After surgery
Once the surgical procedure is finished, the surgeon swings the microscope
out of the operating area into the parking position of the suspension arm. By
pressing the reset button on the XY coupling, the system position is initialized
to a start value, and the system is ready for the next patient. The drape or the
resterilizable caps are removed by the surgeon or by another sterile person.
The drapes are disposed of in accordance with national hospital regulations.
The caps can be resterilized.
OPMI Lumera i can be cleaned and disinfected.
Disposal
After the end of its service life, the product must be disposed of as an elec-
tronic device in accordance with national laws.

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Notes for the operator
Correct operation of the device is required in order to ensure safe use:
•Please familiarize yourself thoroughly with these instructions for use
before using the device for the first time.
•Please also observe the instructions for use applicable to other equipment.
You can obtain additional information from ZEISS Service.
•The instructions for use contain warnings and safety information that
describe the possible residual risks.
Follow these instructions carefully to reduce the residual risks for users
and patients to a minimum!
Duties of the operator
•Only operate the device within the scope of its intended use.
•Note the labels attached to the system! (see page 34)
Legal regulations •Observe the applicable legal provisions concerning accident prevention
and occupational safety in your country.
•If required by the applicable national laws and regulations, connect the
device to the “Special Emergency Power Supply”.
Reporting to manufacturer
and authorities
•If a serious incident occurs in connection with this medical device affecting
the operator or another person, the operator (or person responsible) must
report this serious incident to the manufacturer or seller of the medical
device. In the European Union, the operator must report this serious inci-
dent to the competent authority in his country.
Notes on the system •Make sure that the installation conditions and the use of the device meet
the surgical requirements:
–Lowvibration
– Clean environment
– Avoid extreme mechanical stress

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Safety measures OPMI Lumera®i on floor stand
•Never look at the sun through the binocular tube, the objective lens, or an
eyepiece.
•The maximum brightness of the lamp(s) can drop over time (normal prop-
erty of device).
Ambient conditions •Do not operate the supplied devices under power,
– in explosive atmospheres,
– at a distance of less than 25 cm from flammable anesthetics or volatile
solvents such as alcohol, benzene, or similar substances.
•Do not store or use this device in damp areas. Do not expose the system
to dripping water, running water, gushing water, sprayed water, or
splashes.
•Ensure that no liquids can enter the device.
Electrical safety •Always switch off the device before you disconnect or connect it from the
electricity network, if you will not be using it for an extended period of
time, or if you want to clean its surface.
•Switch off the device at the power switch if you notice any smoke, sparks,
or unusual noise. Do not use the device until it has been repaired by the
ZEISS Service team.
A potential equalization connector is provided on the instrument’s connection
panel (see IEC 60601-1). 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 multiple sockets!
•Do not remove any parts of the housing! The system contains components
that carry high voltage and may cause electric shock.
•Do not touch the device if your body is electrostatically charged and the
device is not grounded.
•Do not pull at the light guide, power cord, or any other connecting cables.
•Please note the information on EMC (electromagnetic compatibility) in the
section “Device data” on page 150.

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Transport & service •The system may be transported over long distances (e.g. during reloca-
tion, return for repair, etc.) only in its original packaging or in special
return packaging. Please contact your dealer or ZEISS Service for this
purpose.
•If there is a malfunction, and you cannot resolve the issue by referring to
the section “What to do in the event of malfunctions”, attach an “Out of
order” sign to the device and contact ZEISS Service.
Safety inspection •To prevent any impairment of the system’s safety as a result of ageing,
wear, etc., the operator must ensure, in accordance with the applicable
national regulations, that the regular technical safety checks defined for
this system are performed on schedule and to the stipulated extent.
The technical safety checks must only be performed by ZEISS or persons
authorized by ZEISS. The following safety inspections should be
performed as a minimum for the system:
– Availability of the instructions for use
– Visual inspection of the device and its accessories for damage, as well
as legibility of markings and labels
– Leakage current test
– Test of protective ground conductor
– Function and wear test of the brakes
– Functional check of all switches, buttons, connectors, and indicator
lamps on the device
– Functional test of the manual mode without the patient, at least every
six months
Medical electrical systems Any additional equipment you connect to medical electrical devices
must demonstrably comply with the applicable standards and directives
(e.g. IEC 60950-1 for data processing equipment).
In addition, all configurations must meet the standard requirements for
medical electrical systems (see IEC 60601-1).
Anyone connecting additional equipment to medical electrical devices is a
system configurer and, as such, is responsible for compliance of the system
with the normative requirements for medical electrical systems.
Please note that local legislation takes priority over the above-mentioned
normative requirements. If you have any questions, contact your local dealer
or ZEISS Service.

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•Never attempt to forcefully connect any electrical connectors (plugs, sock-
ets). If connection is not readily possible, check again whether the plug fits
the socket. If any of the connectors are damaged, have the ZEISS Service
team repair them.
•When mounting accessory equipment, please make sure that the admissi-
ble total weight of the surgical microscope is not exceeded.
(See label “Maximum load” or chapter “Technical data”.)
•When mounting non-ZEISS equipment, make sure that sufficient free
space is available for focus positioning.
Requirements to be met by the user
The device may be operated only by properly instructed and trained persons.
The operator must ensure that the personnel working with the system possess
the necessary qualifications and training.
•Keep the instructions for use accessible to the operating personnel at all
times.
•Modifications and repairs on this device or any ZEISS equipment operated
together with this device may only be performed by ZEISS Service.
Liability and warranty
Warranty and liability depend on the contractually stipulated conditions.
Loss of warranty
The manufacturer is not liable for damage caused by unauthorized persons
modifying the system. Furthermore, this will forfeit any rights to claims under
the warranty.

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Not for diagnostic purposes You must not use stored video sequences, video clips (extracted sequences),
single images, and live images for diagnostic purposes.
Since the video cameras and monitors have not been calibrated, the visualized
video sequences, video clips, and single images may include deviations in
scale, color, and shape. Transmission to other monitors, in particular, may
change the display of the images.
Incorrect data might be used as a basis for subsequent treatment. This could
lead to unnecessary or incorrect surgery.
•Make sure that stored video sequences, video clips, single images, and live
images are never used for diagnostic purposes.

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Requirements for operation
ZEISS Service or an expert authorized by ZEISS will install the system.
Please make sure that the following requirements continue to be met
for further operation:
The connecting components have been properly connected. The screw
connections have been firmly tightened.
All cables and plugs must be in perfect working condition.
The voltage set on the system corresponds to the rated line voltage at the
site of installation.
The power cord has been plugged into a power outlet which is properly
grounded.
The device is connected with the power cord supplied.
Before every use
•Make sure that all functional tests prior to use are performed, and the
requirements specified above fulfilled.
•Go through the checklist in the section “Operation” (see page 95).
•Comply with all symbols, instructions, and labels on the device.
•Never cover any ventilation openings.
•Press the locking tabs on the stand base
to secure the stand in position. Make sure that the floor stand is stable and
cannot roll away.
•Check that the movement of the surgical microscope is unobstructed to
avoid any collisions and damage to cables.
•Check the user settings in the software to avoid unexpected behavior of
the system.