Zeiss opmi lumera 700 User manual

OPMI LUMERA 700
Software Release 3.1
Instructions for Use

Copyright
© 2018, Carl Zeiss Meditec AG, Jena
Brand names/Trademarks
CALLISTOeye, Invertertube, HaMode, KTRACK, MEDIALINK,
OPMILUMERA, RESIGHT, SCI, Superlux, VISULUX, Visionguard and
ZALIGN are either trademarks or registered trademarks of Carl
Zeiss Meditec AG or other companies of the ZEISS Group in
Germany and/or other countries.
All other trademarks mentioned in this document are the property
of their respective owners.

Instructions for Use Table of contents
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Table of contents
1 Notes on Instructions for Use..................................................................... 11
1.1 Device name .......................................................................................................................11
1.2 Area of application .............................................................................................................11
1.3 Purpose and storage of the documentation .......................................................................11
1.4 Questions and comments ...................................................................................................11
1.5 Conventions in this document ............................................................................................11
1.5.1 Conventions in all text areas............................................................................................................11
1.5.2 Conventions in a course of action....................................................................................................12
1.6 Other applicable documents...............................................................................................13
2 Safety notes ............................................................................................... 15
2.1 Target group ......................................................................................................................15
2.2 Area of use .........................................................................................................................15
2.2.1 Intended use ...................................................................................................................................15
2.2.2 Normal use......................................................................................................................................15
2.3 Responsibilities and duties of the operator ........................................................................16
2.3.1 Messages to manufacturer and authorities ......................................................................................17
2.4 Measures and duties of the operator..................................................................................18
2.5 Electromagnetic compatibility ............................................................................................19
2.6 Requirements for operation................................................................................................19
2.6.1 Before commissioning for the first time ...........................................................................................19
2.6.2 Before every use..............................................................................................................................20
2.6.3 During operation.............................................................................................................................22
2.6.4 After every use ................................................................................................................................23
2.7 Measures to prevent phototoxic injury ...............................................................................24
2.7.1 Illumination characteristics (spectral composition)............................................................................24
2.7.2 Illumination intensity .......................................................................................................................24
2.7.3 Angle of illumination .......................................................................................................................25
2.7.4 Focus of the light source .................................................................................................................25
2.7.5 Exposure time to light .....................................................................................................................25
2.8 Maximum radiation exposure.............................................................................................27
2.8.1 Maximum radiation exposure times with red reflex illumination ......................................................27
2.8.2 Maximum radiation exposure times with surrounding field illumination...........................................28
2.8.3 Maximum radiation exposure times with integrated slit illuminator .................................................28
2.8.4 References ......................................................................................................................................28
3 Description of the device............................................................................ 31
3.1 Device marking...................................................................................................................31
3.2 Device setup .......................................................................................................................35
3.2.1 CALLISTOeye Panel PC....................................................................................................................36
3.2.2 Support arm for CALLISTO eye Panel PC ..........................................................................................36
3.2.3 Lamp housing .................................................................................................................................37

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3.2.4 Suspension arm...............................................................................................................................39
3.2.5 XY coupling.....................................................................................................................................39
3.2.6 Overhead display.............................................................................................................................40
3.2.7 Surgical microscope.........................................................................................................................40
3.2.8 Assistant's microscope ....................................................................................................................42
3.2.9 14-function foot control panel ........................................................................................................43
3.2.10 Stand base ......................................................................................................................................43
3.2.11 Stand column ..................................................................................................................................44
3.2.12 Support arm with connector panel ..................................................................................................44
3.2.13 Integrated 22" monitor ...................................................................................................................45
3.2.14 Support arm for integrated 22" monitor..........................................................................................45
3.2.15 Instrument tray................................................................................................................................46
3.2.16 Integrated keratoscope ring ............................................................................................................46
3.2.17 Connections on the surgical microscope..........................................................................................47
3.2.18 Connections on the assistant's microscope......................................................................................47
3.2.19 Connector panel..............................................................................................................................48
3.2.20 Connector panel for the integrated HD camera ...............................................................................48
3.2.21 CALLISTOeye Panel PC connector panel (model I) ...........................................................................49
3.2.22 CALLISTOeye Panel PC connector panel (model II) ..........................................................................49
3.3 Control elements and displays ............................................................................................50
3.3.1 Superlux Eye light source fault signal ...............................................................................................50
3.3.2 Halogen light source fault signal......................................................................................................51
3.3.3 LED light source fault signal.............................................................................................................51
3.3.4 Manual mode fault signal................................................................................................................52
3.3.5 Overhead display.............................................................................................................................53
3.3.6 Surgical microscope.........................................................................................................................54
3.3.7 Assistant's microscope ....................................................................................................................55
3.3.8 Invertertube E..................................................................................................................................56
3.3.9 Widefield eyepiece ..........................................................................................................................57
3.3.10 Handgrips........................................................................................................................................57
3.3.11 14-function foot control panel ........................................................................................................58
3.3.12 XY coupling.....................................................................................................................................59
3.3.13 Suspension arm...............................................................................................................................60
3.3.14 Control panel ..................................................................................................................................61
3.3.15 CALLISTOeye Panel PC (model I) .....................................................................................................62
3.3.16 CALLISTOeye Panel PC (model II) ....................................................................................................63
3.3.17 Superlux Eye light source.................................................................................................................64
3.3.18 Halogen light source .......................................................................................................................64
3.4 Software description ..........................................................................................................65
3.4.1 Structure of the operating panel......................................................................................................65
3.4.2 Bottom bar......................................................................................................................................65
3.4.3 Status bar........................................................................................................................................66
3.4.4 Color code ......................................................................................................................................67
3.4.5 Interactive buttons ..........................................................................................................................67
3.4.6 Navigation buttons..........................................................................................................................69
3.4.7 Control panel keyboard ...................................................................................................................70
3.4.8 Settings for daily operation - main menu, tab 1 ...............................................................................71
3.4.9 Basic device settings - main menu, tab 2 .........................................................................................72
3.4.10 Factory settings for handgrips and 14-function foot control panel...................................................73
3.4.11 Configurable assignments for handgrips and the 14-function foot control panel .............................76
3.5 Functional description ........................................................................................................79
3.5.1 Operating concept ..........................................................................................................................79
3.5.2 SCI illumination ...............................................................................................................................81

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3.5.3 Main and auxiliary light source ........................................................................................................81
3.5.4 Total magnification .........................................................................................................................82
3.5.5 Fast focus........................................................................................................................................82
3.5.6 RESIGHT functions...........................................................................................................................83
3.5.7 DeepView .......................................................................................................................................83
3.5.8 Reset options ..................................................................................................................................83
3.5.9 Links................................................................................................................................................84
3.5.10 Manual mode..................................................................................................................................84
3.5.11 Assistant's microscope ....................................................................................................................85
3.5.12 IDIS (Integrated Data Injection System)............................................................................................85
3.5.13 Integrated slit illumination...............................................................................................................86
3.5.14 Integrated HD camera .....................................................................................................................86
3.5.15 Integrated HD video and image recording .......................................................................................87
4 Installation ................................................................................................. 89
4.1 Safety during installation....................................................................................................89
4.2 Preparing the installation ...................................................................................................90
4.2.1 Requirements for connecting the device to an IT network ...............................................................90
4.3 Connections........................................................................................................................92
4.3.1 Connecting the power supply..........................................................................................................92
4.3.2 Connecting the 14-function foot control panel................................................................................93
4.3.3 Setting up a network connection with the CALLISTO eye Panel PC ..................................................94
4.3.4 Setting up a network connection with integrated CALLISTO eye Panel PC .......................................98
4.3.5 Connecting IDIS via CALLISTO eye Panel PC...................................................................................100
4.3.6 Connecting external video devices.................................................................................................102
4.3.7 Connecting the strain relief ...........................................................................................................104
5 Daily startup............................................................................................. 105
5.1 Outfitting the surgical and assistant's microscopes with accessories ...............................105
5.1.1 Replacing accessories and components .........................................................................................105
5.1.2 Connecting the Invertertube E .......................................................................................................108
5.1.3 Connecting RESIGHT 700 ..............................................................................................................110
5.1.4 Connecting auxiliary illumination ...................................................................................................110
5.1.5 Balancing the system.....................................................................................................................111
5.2 Adjusting the surgical and assistant's microscopes ..........................................................113
5.2.1 Adjusting the downward travel limit..............................................................................................113
5.2.2 Adjusting friction...........................................................................................................................114
5.2.3 Positioning the assistant's microscope ...........................................................................................114
5.2.4 Adjusting microscope tilt ...............................................................................................................115
5.2.5 Adjusting the tubes and eyepieces.................................................................................................116
5.2.6 Adjusting the working distance and magnification ........................................................................117
5.3 Positioning the device in the OR.......................................................................................118
5.3.1 Moving the device.........................................................................................................................118
5.3.2 Swiveling the device over the surgical field ....................................................................................119
5.3.3 Placing the device in the working position.....................................................................................120
5.3.4 Orienting the integrated CALLISTO eye Panel PC ...........................................................................121
5.3.5 Orienting the integrated 22" monitor ............................................................................................122
6 Before every use....................................................................................... 123

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6.1 Safety during preparation.................................................................................................123
6.2 Switching the device on ...................................................................................................124
6.3 Function test ....................................................................................................................125
6.3.1 Device function tests .....................................................................................................................125
6.3.2 Function tests for device with fundus viewing system....................................................................126
6.4 Preparing the system for sterile use .................................................................................127
6.4.1 Attaching sterile accessories ..........................................................................................................127
6.4.2 Placing the drape ..........................................................................................................................129
7 Operation................................................................................................. 131
7.1 Safety during operation....................................................................................................131
7.2 Configuring user and surgery profiles...............................................................................132
7.2.1 Creating and activating users.........................................................................................................132
7.2.2 Changing the user language..........................................................................................................133
7.2.3 Deleting users ...............................................................................................................................133
7.2.4 Creating a "Cataract" surgery profile .............................................................................................133
7.2.5 Creating a "Retina RESIGHT" surgery profile ..................................................................................134
7.2.6 Creating a "Retina Contact" surgery profile ...................................................................................135
7.2.7 Assigning the RESIGHT function to the surgery profile ...................................................................136
7.2.8 Configuring working steps ............................................................................................................137
7.2.9 Deleting a surgery profile ..............................................................................................................138
7.3 Device-specific software configuration.............................................................................138
7.3.1 Setting the date and time..............................................................................................................138
7.3.2 Configuring optics.........................................................................................................................139
7.3.3 Pairing...........................................................................................................................................140
7.3.4 Configuring the video signal of the integrated HD camera.............................................................141
7.3.5 Configuring the network connection with CALLISTO eye ...............................................................142
7.3.6 Configuring integrated HD video and image recording ..................................................................144
7.4 Configuring the software for specific users ......................................................................146
7.4.1 Configuring the 14-function foot control panel .............................................................................147
7.4.2 Configuring the handgrips.............................................................................................................147
7.4.3 Configuring image inversion on the Invertertube E ........................................................................148
7.4.4 Configuring the direction of the XY coupling.................................................................................149
7.4.5 Configuring speeds........................................................................................................................149
7.4.6 Configuring the speed of the RESIGHT 700 internal focus..............................................................149
7.4.7 Configuring the overhead display ..................................................................................................150
7.4.8 Configuring fast focus ...................................................................................................................150
7.4.9 Configuring links ...........................................................................................................................151
7.4.10 Configuring reset options ..............................................................................................................152
7.5 Daily operation .................................................................................................................152
7.5.1 Setting the illumination .................................................................................................................153
7.5.2 Setting the total magnification ......................................................................................................157
7.5.3 Setting DeepView..........................................................................................................................158
7.5.4 Setting the focus distance .............................................................................................................159
7.5.5 Changing the XY coupling position ...............................................................................................159
7.5.6 Setting the integrated keratoscope ring.........................................................................................160
7.5.7 Setting the HD Digizoom...............................................................................................................161
7.5.8 Setting the integrated HD camera .................................................................................................161
7.5.9 Recording......................................................................................................................................165
7.5.10 Transferring control to CALLISTO eye ............................................................................................172

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7.5.11 Ending control via CALLISTO eye ...................................................................................................173
7.6 Typical operating sequence ..............................................................................................174
7.6.1 Starting work ................................................................................................................................174
7.6.2 Carrying out the working steps......................................................................................................175
7.6.3 Stopping work ..............................................................................................................................175
7.7 Switching the device off ...................................................................................................176
8 Cleaning and disinfection ......................................................................... 177
8.1 Safety during cleaning and disinfection............................................................................177
8.2 Cleaning ...........................................................................................................................177
8.2.1 Cleaning optical surfaces ...............................................................................................................177
8.2.2 Cleaning mechanical surfaces ........................................................................................................177
8.2.3 Fogging of optical surfaces............................................................................................................177
8.3 Disinfection ......................................................................................................................178
8.3.1 Disinfection of surfaces .................................................................................................................178
9 Maintenance ............................................................................................ 179
9.1 Maintenance schedule for the operator............................................................................179
9.1.1 Every six months............................................................................................................................179
9.2 Maintenance schedule for the authorized service.............................................................179
9.2.1 Every six months............................................................................................................................179
9.2.2 Every twelve months .....................................................................................................................179
9.2.3 Every two years .............................................................................................................................181
9.2.4 Every four years.............................................................................................................................181
9.2.5 Every six years ...............................................................................................................................181
9.3 Performing safety inspections ..........................................................................................181
10 Troubleshooting....................................................................................... 183
10.1 Localizing malfunctions ....................................................................................................183
10.1.1 Response to faults with messages .................................................................................................183
10.1.2 Exporting log files..........................................................................................................................183
10.2 Faults (with messages) .....................................................................................................184
10.3 Faults (without messages) ................................................................................................185
10.3.1 Device faults..................................................................................................................................185
10.3.2 Integrated HD video and image recording faults............................................................................187
10.3.3 14-function foot control panel faults .............................................................................................188
10.3.4 Wired 14-function foot control panel faults...................................................................................189
10.4 Troubleshooting work ......................................................................................................190
10.4.1 Activating manual mode................................................................................................................190
10.4.2 Operating the device in manual mode ...........................................................................................191
10.4.3 Changing the halogen lamp ..........................................................................................................192
10.4.4 Swiveling the backup xenon lamp into position and resetting the remaining service hours ............193
10.4.5 Changing the Superlux Eye light source lamp module....................................................................194
10.4.6 Setting the gas spring on the integrated 22" monitor ....................................................................195
10.4.7 Increasing mobility of the suspension arm on the integrated 22" monitor ....................................196
10.4.8 Increasing mobility of the monitor mount on the integrated 22" monitor......................................197

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10.4.9 Increasing mobility of the monitor mount on the integrated CALLISTO eye Panel PC support arm .197
10.4.10 Establishing cable connections for the 14-function foot control panel ...........................................198
10.4.11 Displaying the firmware versions ...................................................................................................198
10.4.12 Opening the service menu.............................................................................................................198
11 Technical specifications............................................................................ 201
11.1 Essential performance features ........................................................................................201
11.2 Compliance.......................................................................................................................201
11.3 Electrical data...................................................................................................................202
11.3.1 Stand ............................................................................................................................................202
11.3.2 Light sources .................................................................................................................................202
11.3.3 Integrated HD camera ...................................................................................................................203
11.3.4 Integrated HD video and image recording .....................................................................................204
11.3.5 Integrated keratoscope ring ..........................................................................................................205
11.3.6 Integrated 22" monitor .................................................................................................................205
11.4 Mechanical data ...............................................................................................................205
11.4.1 Integrated slit illumination.............................................................................................................205
11.4.2 Integrated 22" monitor .................................................................................................................205
11.5 Optical data......................................................................................................................206
11.5.1 Surgical microscope.......................................................................................................................206
11.5.2 Objective lenses.............................................................................................................................206
11.5.3 Objective lenses with support ring.................................................................................................206
11.5.4 Eyepieces ......................................................................................................................................206
11.6 Dimensions and weights...................................................................................................207
11.6.1 Dimensions and swiveling ranges ..................................................................................................207
11.6.2 Support arm for integrated CALLISTO eye Panel PC .......................................................................208
11.6.3 Support arm for integrated 22" monitor........................................................................................209
11.6.4 Maximum weight capacity.............................................................................................................210
11.6.5 Total weight..................................................................................................................................210
11.7 Ambient requirements for operation ................................................................................211
11.8 Ambient requirements for transport and storage .............................................................211
11.9 Guidance and manufacturer´s declaration – electromagnetic immunity............................211
11.9.1 EMC - electromagnetic compatibility IEC 60601-1-2 ......................................................................213
12 Accessories and spare parts ..................................................................... 215
12.1 Accessories .......................................................................................................................215
12.1.1 Video accessories ..........................................................................................................................215
12.1.2 14-function foot control panel ......................................................................................................215
12.1.3 Fundus viewing systems ................................................................................................................215
12.1.4 Additional illumination ..................................................................................................................215
12.1.5 Sterilizable caps.............................................................................................................................216
12.1.6 Drapes...........................................................................................................................................216
12.2 Spare parts .......................................................................................................................216
12.2.1 Lamps and light guides..................................................................................................................216
12.2.2 Dust cover.....................................................................................................................................216
12.2.3 Network cable...............................................................................................................................216
12.2.4 Country-specific power cable.........................................................................................................217

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12.3 Components .....................................................................................................................217
12.3.1 Tubes for surgical and assistant's microscopes...............................................................................217
12.3.2 Eyepieces for surgical and assistant's microscopes.........................................................................217
12.3.3 Intermediate pieces for surgical microscope ..................................................................................217
12.3.4 Objective lenses.............................................................................................................................218
12.3.5 Coobservation ...............................................................................................................................218
12.3.6 Integrated components (factory installed)......................................................................................218
12.3.7 CALLISTO eye ................................................................................................................................219
12.4 UC kits ..............................................................................................................................219
13 Decommissioning ..................................................................................... 221
13.1 Cleaning before storage ...................................................................................................221
13.1.1 Cleaning the device and accessories ..............................................................................................221
14 Packaging and transport.......................................................................... 223
14.1 Preparing for transport.....................................................................................................223
14.1.1 Placing the device in the transport position ...................................................................................223
15 Disposal ................................................................................................... 225
15.1 Disposal of the device.......................................................................................................225
Glossary ................................................................................................... 227
Keyword index ......................................................................................... 231

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Instructions for Use 1 Notes on Instructions for Use
OPMI LUMERA 700 1.1 Device name
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1 Notes on Instructions for Use
1.1 Device name
OPMILUMERA700 is referred to as "device" in the present Instruc-
tions for Use
1.2 Area of application
The present Instructions for Use apply to OPMILUMERA700 with
Software Release 3.1 and the following identification:
• Reference number: 6634 OPMILUMERA700
1.3 Purpose and storage of the documentation
These Instructions for Use explain the safety features, functions and
performance parameters of the device. They contain instructions on
the safe use of the device and identify measures for its care and
maintenance.
Correct operation of the device is imperative for its safe and
successful function.
uRead these Instructions for Use before setting up and using the
device the first time.
uKeep the Instructions for Use accessible for all users at all times.
uPass the Instructions for Use to future owners of the device.
1.4 Questions and comments
uIf you have any questions or comments concerning these
Instructions for Use or the device itself, please contact ZEISS
Service.
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med
1.5 Conventions in this document
Certain types of information are specially marked in this document
for better recognition.
1.5.1 Conventions in all text areas
• This is a list.
– This is a second level list.
This is a cross-reference: Questions and comments [}11].
This is bold type.
This is software code or program text.

1 Notes on Instructions for Use Instructions for Use
OPMI LUMERA 7001.5 Conventions in this document
12 / 236 G-30-1673-en - 14.0 - 2018-07-12
Names of software dialogs, fields or menus, and software
messages are marked by quotation marks:
• "View" menu.
• "Do you want to save the settings?"
The steps in menu and file paths are separated by slashes:
• "File / Save as"
• "My documents / Documents"
Keys, buttons, knobs, levers and other operating controls are
marked by square brackets:
• [START] key
• [Next] button
1.5.2 Conventions in a course of action
WARNING! This is warning information about hazards that can cause
death or severe injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
CAUTION! This is warning information about hazards that can cause
injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
NOTE This is warning information about hazards that can cause
property damages if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
þThis is a requirement that must be met before the start of a
sequence of actions.
1. This is a command.
2. CAUTION!This is a warning message about hazards that
can occur during a single action. This is a command.
ðThis is the result of a sequence of actions.

Instructions for Use 1 Notes on Instructions for Use
OPMI LUMERA 700 1.6 Other applicable documents
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1.6 Other applicable documents
Document type Document title Optional
Product overview ZEISS Video Accessories No
Instructions for Use Preparation of Resteril-
izable Products
No
Instructions for Use VISULUX Yes
Instructions for Use RESIGHT500 &
RESIGHT700
Yes
Instructions for Use CALLISTOeye Yes
Instructions for Use CALLISTOeye Panel PC
(model I)
Yes
Instructions for Use CALLISTOeye Panel PC
(model II)
Yes
Instructions for Use CALLISTOeye Basic
Functions
Yes
Instructions for Use CALLISTOeye - Software
Add-On for Assistance
Functions
Yes
Instructions for Use CALLISTOeye - Software
Add-On for
OPMILUMERA700 Control
Yes
Instructions for Use CALLISTOeye - Software
Add-On for VISALIS500
Parameter Display
Yes

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Instructions for Use 2 Safety notes
OPMI LUMERA 700 2.1 Target group
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2 Safety notes
2.1 Target group
These Instructions for Use are intended for physicians, medical and
technical staff, and nurses who are responsible for preparing,
operating or maintaining the device following training.
It is the duty of the equipment owner/operator to train and instruct
all operating personnel.
2.2 Area of use
2.2.1 Intended use
The OPMI LUMERA 700 is a surgical microscope designed for the
illumination and magnification of the surgical area and for the
support of visualization in surgical procedures in the field of
ophthalmology.
2.2.2 Normal use
On account of its mechanical construction and the characteristics
listed below, the device is suited for performing surgical procedures
on the anterior and posterior segments of the eye:
• SCI illumination system (Stereo Coaxial Illumination)
• A range of illumination sources
• Attachable fundus viewing systems (RESIGHT500,
RESIGHT700)
Once the power switch has been activated, the device can be safely
and easily moved into its operating position after the magnetic
brakes have been released, either by using the handgrips or the
suspension arm. Before the start of surgery, a sterile personnel
member covers the microscope with drapes and applies resteril-
izable caps.
The surgeon or a sterile personnel member positions the
microscope and focuses it. During surgery, the most frequently
used operator functions, such as focus, magnification, XY
movement, light intensity up/down and adjustment of the illumi-
nation level, are controlled by means of the foot control panel,
allowing the hands to remain free for operating. Certain settings,
such as the illumination level, unlocking of the magnetic brakes or
the insertion of RESIGHT 500 or RESIGHT 700 for surgical proce-
dures conducted on the anterior segment of the eye, are made by
hand. Additional video accessories can be attached to the device
for training purposes or to visually display the progress of surgery
for personnel.

2 Safety notes Instructions for Use
OPMI LUMERA 7002.3 Responsibilities and duties of the operator
16 / 236 G-30-1673-en - 14.0 - 2018-07-12
When finished, the surgeon swivels the microscope out of the
surgical field and into the park position. Pressing the reset button
on the XY coupling, or positioning the device in the park position,
resets the device to its initial values and makes it ready for the next
operation. The drape or the resterilizable caps are removed by the
surgeon or by a nurse. The drape is to be disposed of in accordance
with the hospital regulations of the respective country. The resteril-
izable caps can be sterilized again. The device can be cleaned and
disinfected.
The product must be regularly checked for full functionality by a
hospital technician.
At the end of the electronic device's service life, it must be disposed
of in accordance with the regulations of the respective country.
2.3 Responsibilities and duties of the operator
Operating personnel
The device may be operated only by properly instructed and trained
persons.
uMake sure that the operating personnel are appropriately
trained and instructed.
uMake sure that the operating personnel have read and under-
stood the Instructions for Use.
uKeep the Instructions for Use available at all times for the
operating personnel.
uTo facilitate access for all operating personnel: Request
additional copies of the Instructions for Use as required from
ZEISS.
uSpecify the competencies for handling the device and state
who is authorized to perform what tasks.
uDetermine the reporting obligations for malfunction and
damage and make them known. Notification of the manufac-
turer and authorities. [}17]
uProvide the necessary protective clothing.
uRegularly check that the legal regulations applicable in your
country with regard to accident prevention and work safety are
being complied with.
Safety inspections
uTo prevent a decrease in device safety due to aging and wear:
Implement regular safety inspections as specified for this device
by the applicable national regulations.
The safety inspections may only be performed by the manufacturer
or qualified personnel.
uComply with the specified time limits.

Instructions for Use 2 Safety notes
OPMI LUMERA 700 2.3 Responsibilities and duties of the operator
G-30-1673-en - 14.0 - 2018-07-12 17 / 236
uCarry out checks according to the extent specified.
The safety inspections of the device should at least comprise the
following points:
• Availability of the Instructions for Use
• Visual inspection of the device and accessories for damage, as
well as legibility of the labels
• Leakage current test
• Test of protective ground conductor
• Function and wear test of the brakes
• Function test of all switches, buttons, sockets and indicator
lamps of the device
Maintenance and inspection
uTo ensure safe operation of the device and reach the expected
service life: Comply with the maintenance and inspection
intervals specified in these Instructions for Use.
Modifications to the product
uWARNING: This device must not be modified without the
manufacturer’s approval. If the device is modified, suitable
inspections and testing must be completed to ensure that it can
still be used safely.
Accessories and additional equipment
uIf you want to connect accessories or additional equipment to
the device: Contact your ZEISS contact partner [}11].
Any additional equipment connected to medical electrical devices
must demonstrably comply with the applicable IEC or ISO standards
(e.g. IEC60950 for data processing equipment).
In addition, all configurations must meet the normative require-
ments for medical systems (see IEC60601-1-1 or Clause 16 of the
3rd edition of IEC60601-1 respectively).
Anyone connecting additional equipment to medical electrical
systems is a system configurer and as such responsible for
compliance of the system with the standards for systems.
Local legislation has priority over the above normative require-
ments.
2.3.1 Messages 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 incidence to the manufacturer
or seller of the medical product. In the European Union, the
operator must report this serious incident to the responsible
authorities in the applicable country.

2 Safety notes Instructions for Use
OPMI LUMERA 7002.4 Measures and duties of the operator
18 / 236 G-30-1673-en - 14.0 - 2018-07-12
2.4 Measures and duties of the operator
Electrical safety
uAlways switch off the device before connecting it to or discon-
necting it from the power supply, for cleaning its surface, or if
it will not be used for a prolonged period of time.
uOnly connect the device to a power supply that complies with
the values specified on the rating label.
uDo not use multiple sockets!
uDo not use extension cables!
uDo not touch the device if your body is electrostatically charged
and the device is not grounded.
uConnect the device via the potential equalization connection
(according to IEC 60601-1) to other active devices with the
same ground potential or connect it to a protective ground
connection.
uPlease observe the information on electromagnetic compati-
bility (EMC).
The device contains freely accessible live components. If you
remove the housing, you run the risk of electric shock.
uNever open the device!
Environmental conditions
uMake sure that the installation conditions and the operation of
the device comply with the surgical requirements:
• Low vibration
• Clean environment
• Avoid extreme mechanical stress
uDo not use power-operated devices included in the delivery
package
• in explosive atmospheres,
• at a distance of less than 25 cm from flammable anesthetics or
volatile solvents such as alcohol, benzine or similar substances.
uDo not use or store the device in damp rooms. Do not expose
the device to water splashes, dripping water or sprayed water.
uEnsure that fluids cannot enter the device.
Symbols and labels
uNote the symbols and labels attached to the device!

Instructions for Use 2 Safety notes
OPMI LUMERA 700 2.5 Electromagnetic compatibility
G-30-1673-en - 14.0 - 2018-07-12 19 / 236
Transport
uOnly transport the device over long distances (e.g. relocation,
return for repair) in its original packaging or special return
packaging.
uPlease contact your dealer or ZEISS Service for this purpose.
2.5 Electromagnetic compatibility
The device is subject to special requirements regarding electromag-
netic compatibility (EMC). The following factors can cause EMC
disturbances:
• Portable and mobile HF communication equipment in the
vicinity of the device.
• Other devices set up in the vicinity or stacked together with the
device.
• Accessories, cables and spare parts not specified in the Instruc-
tions for Use and not sold by ZEISS as spare parts.
You can prevent EMC disturbances by using the following precau-
tionary measures:
uPlease comply with the Instructions for Use.
uObserve the EMC guidelines in the Technical Specifications
chapter.
uOnly use accessories, transformers, cables and spare parts
specified in the Instructions for Use or approved by ZEISS for
this device.
uIf you are using radio communication equipment or compo-
nents for radio transmission: Keep a distance of 30cm to all
components of the device.
uIf you are installing the device near or stacking it with other
devices: Check to make sure the device is operating correctly in
this configuration.
2.6 Requirements for operation
2.6.1 Before commissioning for the first time
Installation performed by technical personnel or ZEISS
Service
Please make sure that the following requirements continue to be
met for further operation:
uMake sure that the connecting components are properly set
and that all screw connections are securely tightened.
uMake sure that all cables and plugs are in proper condition.

2 Safety notes Instructions for Use
OPMI LUMERA 7002.6 Requirements for operation
20 / 236 G-30-1673-en - 14.0 - 2018-07-12
uMake sure that the device is connected to an electrical outlet
with a proper protective ground conductor.
uDetermine the supply voltage at the installation site and set the
voltage of the device in accordance with the installation site's
supply voltage.
uMake sure the device is connected using the provided power
cable.
Hazards arising from connecting the device to an IT network
The following safety measures should be observed in order to
prevent injuries or damage:
uCheck to make sure that the requirements for connecting the
device to an IT network are met. [}90]
Hazards arising from condensation of air humidity
Moving the device from a cold environment (T<10°C) to a warm
one may cause air humidity to condense.
uIf you move the device from a cold environment to a warm
one, wait at least one hour before switching the device on to
allow it to reach the environment's ambient temperature.
2.6.2 Before every use
Hazards arising from phototoxicity
To prevent phototoxic damage to the patient's eye:
uCheck the light source for visible damage.
uCheck the filter setting.
uSwitch off the light source for light guides that are not being
used and attach them to the mount provided.
Hazards arising from attached accessories and components
The following safety measures should be observed in order to
prevent injuries or damage:
uNever exceed the device's maximum permitted weight load.
uAlways route cables so that they do not hinder the user.
uNever cover any ventilation openings. Doing so can cause the
device to overheat and fail.
uNever attempt to forcefully connect any electrical connectors. If
a connection cannot be made, check to make sure the plug fits
the socket. If any of the connectors are damaged, have the
ZEISS Service team or an authorized service representative
repair them.