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

OPMI Lumera®i on floor stand
Version 9.2
G-30-1720-en Page 3
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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OPMI Lumera®i on floor stand
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

OPMI Lumera®i on floor stand
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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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OPMI Lumera®i on floor stand
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

OPMI Lumera®i on floor stand
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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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OPMI Lumera®i on floor stand
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

OPMI Lumera®i on floor stand Safety measures
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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 measures OPMI Lumera®i on floor stand
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