Instructions for Use
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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 OPMI LUMERA 700
Table of contents
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 1.5.1 1.5.2
Conventions in this document ... 11 Conventions in all text areas... 11 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 2.2.2
Intended use ... 15 Normal use... 15
2.3 2.3.1
Responsibilities and duties of the operator ... 16 Messages to manufacturer and authorities ... 17
2.4
Measures and duties of the operator... 18
2.5
Electromagnetic compatibility ... 19
2.6 2.6.1 2.6.2 2.6.3 2.6.4
Requirements for operation... 19 Before commissioning for the first time ... 19 Before every use... 20 During operation ... 22 After every use ... 23
2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5
Measures to prevent phototoxic injury ... 24 Illumination characteristics (spectral composition)... 24 Illumination intensity ... 24 Angle of illumination ... 25 Focus of the light source ... 25 Exposure time to light ... 25
2.8 2.8.1 2.8.2 2.8.3 2.8.4
Maximum radiation exposure... 27 Maximum radiation exposure times with red reflex illumination ... 27 Maximum radiation exposure times with surrounding field illumination... 28 Maximum radiation exposure times with integrated slit illuminator ... 28 References ... 28
3
Description of the device... 31
3.1
Device marking... 31
3.2 3.2.1 3.2.2 3.2.3
Device setup ... 35 CALLISTO eye Panel PC... 36 Support arm for CALLISTO eye Panel PC ... 36 Lamp housing ... 37
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Instructions for Use OPMI LUMERA 700
3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9 3.2.10 3.2.11 3.2.12 3.2.13 3.2.14 3.2.15 3.2.16 3.2.17 3.2.18 3.2.19 3.2.20 3.2.21 3.2.22
Suspension arm ... 39 XY coupling... 39 Overhead display... 40 Surgical microscope... 40 Assistant's microscope ... 42 14-function foot control panel ... 43 Stand base ... 43 Stand column ... 44 Support arm with connector panel ... 44 Integrated 22" monitor ... 45 Support arm for integrated 22" monitor... 45 Instrument tray... 46 Integrated keratoscope ring ... 46 Connections on the surgical microscope... 47 Connections on the assistant's microscope... 47 Connector panel... 48 Connector panel for the integrated HD camera ... 48 CALLISTO eye Panel PC connector panel (model I) ... 49 CALLISTO eye Panel PC connector panel (model II) ... 49
3.3
Control elements and displays ... 50
3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.3.9 3.3.10 3.3.11 3.3.12 3.3.13 3.3.14 3.3.15 3.3.16 3.3.17 3.3.18
Superlux Eye light source fault signal ... 50 Halogen light source fault signal... 51 LED light source fault signal... 51 Manual mode fault signal ... 52 Overhead display... 53 Surgical microscope... 54 Assistant's microscope ... 55 Invertertube E... 56 Widefield eyepiece ... 57 Handgrips... 57 14-function foot control panel ... 58 XY coupling... 59 Suspension arm ... 60 Control panel ... 61 CALLISTO eye Panel PC (model I) ... 62 CALLISTO eye Panel PC (model II) ... 63 Superlux Eye light source... 64 Halogen light source ... 64
3.4 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6 3.4.7 3.4.8 3.4.9 3.4.10 3.4.11
Software description ... 65 Structure of the operating panel... 65 Bottom bar... 65 Status bar... 66 Color code ... 67 Interactive buttons ... 67 Navigation buttons... 69 Control panel keyboard ... 70 Settings for daily operation - main menu, tab 1 ... 71 Basic device settings - main menu, tab 2 ... 72 Factory settings for handgrips and 14-function foot control panel... 73 Configurable assignments for handgrips and the 14-function foot control panel ... 76
3.5 3.5.1 3.5.2
Functional description ... 79 Operating concept ... 79 SCI illumination ... 81
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Table of contents
3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 3.5.10 3.5.11 3.5.12 3.5.13 3.5.14 3.5.15
Main and auxiliary light source ... 81 Total magnification ... 82 Fast focus... 82 RESIGHT functions... 83 DeepView ... 83 Reset options ... 83 Links... 84 Manual mode... 84 Assistant's microscope ... 85 IDIS (Integrated Data Injection System)... 85 Integrated slit illumination ... 86 Integrated HD camera ... 86 Integrated HD video and image recording ... 87
4
Installation ... 89
4.1
Safety during installation... 89
4.2 4.2.1
Preparing the installation ... 90 Requirements for connecting the device to an IT network ... 90
4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.3.7
Connections... 92 Connecting the power supply... 92 Connecting the 14-function foot control panel... 93 Setting up a network connection with the CALLISTO eye Panel PC ... 94 Setting up a network connection with integrated CALLISTO eye Panel PC ... 98 Connecting IDIS via CALLISTO eye Panel PC... 100 Connecting external video devices... 102 Connecting the strain relief ... 104
5
Daily startup... 105
5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5
Outfitting the surgical and assistant's microscopes with accessories ... 105 Replacing accessories and components ... 105 Connecting the Invertertube E ... 108 Connecting RESIGHT 700 ... 110 Connecting auxiliary illumination ... 110 Balancing the system... 111
5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6
Adjusting the surgical and assistant's microscopes ... 113 Adjusting the downward travel limit... 113 Adjusting friction... 114 Positioning the assistant's microscope ... 114 Adjusting microscope tilt ... 115 Adjusting the tubes and eyepieces... 116 Adjusting the working distance and magnification ... 117
5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5
Positioning the device in the OR... 118 Moving the device... 118 Swiveling the device over the surgical field ... 119 Placing the device in the working position... 120 Orienting the integrated CALLISTO eye Panel PC ... 121 Orienting the integrated 22" monitor ... 122
6
Before every use... 123
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Instructions for Use OPMI LUMERA 700
6.1
Safety during preparation... 123
6.2
Switching the device on ... 124
6.3 6.3.1 6.3.2
Function test ... 125 Device function tests ... 125 Function tests for device with fundus viewing system... 126
6.4 6.4.1 6.4.2
Preparing the system for sterile use ... 127 Attaching sterile accessories ... 127 Placing the drape ... 129
7
Operation ... 131
7.1
Safety during operation... 131
7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.2.5 7.2.6 7.2.7 7.2.8 7.2.9
Configuring user and surgery profiles... 132 Creating and activating users... 132 Changing the user language... 133 Deleting users ... 133 Creating a "Cataract" surgery profile ... 133 Creating a "Retina RESIGHT" surgery profile ... 134 Creating a "Retina Contact" surgery profile ... 135 Assigning the RESIGHT function to the surgery profile ... 136 Configuring working steps ... 137 Deleting a surgery profile ... 138
7.3
Device-specific software configuration ... 138
7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6
Setting the date and time ... 138 Configuring optics ... 139 Pairing... 140 Configuring the video signal of the integrated HD camera... 141 Configuring the network connection with CALLISTO eye ... 142 Configuring integrated HD video and image recording ... 144
7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5 7.4.6 7.4.7 7.4.8 7.4.9 7.4.10
Configuring the software for specific users ... 146 Configuring the 14-function foot control panel ... 147 Configuring the handgrips... 147 Configuring image inversion on the Invertertube E ... 148 Configuring the direction of the XY coupling... 149 Configuring speeds... 149 Configuring the speed of the RESIGHT 700 internal focus... 149 Configuring the overhead display ... 150 Configuring fast focus ... 150 Configuring links ... 151 Configuring reset options ... 152
7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.5.6 7.5.7 7.5.8 7.5.9 7.5.10
Daily operation ... 152 Setting the illumination ... 153 Setting the total magnification ... 157 Setting DeepView... 158 Setting the focus distance ... 159 Changing the XY coupling position ... 159 Setting the integrated keratoscope ring... 160 Setting the HD Digizoom ... 161 Setting the integrated HD camera ... 161 Recording... 165 Transferring control to CALLISTO eye ... 172
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Table of contents
7.5.11
Ending control via CALLISTO eye ... 173
7.6 7.6.1 7.6.2 7.6.3
Typical operating sequence ... 174 Starting work ... 174 Carrying out the working steps... 175 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 8.2.1 8.2.2 8.2.3
Cleaning ... 177 Cleaning optical surfaces ... 177 Cleaning mechanical surfaces ... 177 Fogging of optical surfaces... 177
8.3
Disinfection ... 178
8.3.1
Disinfection of surfaces ... 178
9
Maintenance ... 179
9.1 9.1.1
Maintenance schedule for the operator... 179 Every six months... 179
9.2 9.2.1 9.2.2 9.2.3 9.2.4 9.2.5
Maintenance schedule for the authorized service... 179 Every six months... 179 Every twelve months ... 179 Every two years ... 181 Every four years... 181 Every six years ... 181
9.3
Performing safety inspections ... 181
10
Troubleshooting... 183
10.1 10.1.1 10.1.2
Localizing malfunctions ... 183 Response to faults with messages ... 183 Exporting log files... 183
10.2
Faults (with messages) ... 184
10.3 10.3.1 10.3.2 10.3.3 10.3.4
Faults (without messages) ... 185 Device faults... 185 Integrated HD video and image recording faults... 187 14-function foot control panel faults ... 188 Wired 14-function foot control panel faults... 189
10.4 10.4.1 10.4.2 10.4.3 10.4.4 10.4.5 10.4.6 10.4.7 10.4.8
Troubleshooting work ... 190 Activating manual mode... 190 Operating the device in manual mode ... 191 Changing the halogen lamp ... 192 Swiveling the backup xenon lamp into position and resetting the remaining service hours ... 193 Changing the Superlux Eye light source lamp module... 194 Setting the gas spring on the integrated 22" monitor ... 195 Increasing mobility of the suspension arm on the integrated 22" monitor ... 196 Increasing mobility of the monitor mount on the integrated 22" monitor ... 197
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Instructions for Use OPMI LUMERA 700
10.4.9 10.4.10 10.4.11 10.4.12
Increasing mobility of the monitor mount on the integrated CALLISTO eye Panel PC support arm . 197 Establishing cable connections for the 14-function foot control panel ... 198 Displaying the firmware versions ... 198 Opening the service menu ... 198
11
Technical specifications... 201
11.1
Essential performance features ... 201
11.2
Compliance... 201
11.3 11.3.1 11.3.2 11.3.3 11.3.4 11.3.5 11.3.6
Electrical data... 202 Stand ... 202 Light sources ... 202 Integrated HD camera ... 203 Integrated HD video and image recording ... 204 Integrated keratoscope ring ... 205 Integrated 22" monitor ... 205
11.4
Mechanical data ... 205
11.4.1 11.4.2
Integrated slit illumination ... 205 Integrated 22" monitor ... 205
11.5
Optical data... 206
11.5.1 11.5.2 11.5.3 11.5.4
Surgical microscope... 206 Objective lenses... 206 Objective lenses with support ring... 206 Eyepieces ... 206
11.6 11.6.1 11.6.2 11.6.3 11.6.4 11.6.5
Dimensions and weights... 207 Dimensions and swiveling ranges ... 207 Support arm for integrated CALLISTO eye Panel PC ... 208 Support arm for integrated 22" monitor... 209 Maximum weight capacity... 210 Total weight... 210
11.7
Ambient requirements for operation ... 211
11.8
Ambient requirements for transport and storage ... 211
11.9 11.9.1
Guidance and manufacturer´s declaration – electromagnetic immunity... 211 EMC - electromagnetic compatibility IEC 60601-1-2 ... 213
12
Accessories and spare parts ... 215
12.1 12.1.1 12.1.2 12.1.3 12.1.4 12.1.5 12.1.6
Accessories ... 215 Video accessories ... 215 14-function foot control panel ... 215 Fundus viewing systems ... 215 Additional illumination ... 215 Sterilizable caps... 216 Drapes... 216
12.2 12.2.1 12.2.2 12.2.3 12.2.4
Spare parts ... 216 Lamps and light guides... 216 Dust cover... 216 Network cable... 216 Country-specific power cable... 217
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Table of contents
12.3 12.3.1 12.3.2 12.3.3 12.3.4 12.3.5 12.3.6 12.3.7
Components ... 217 Tubes for surgical and assistant's microscopes... 217 Eyepieces for surgical and assistant's microscopes ... 217 Intermediate pieces for surgical microscope ... 217 Objective lenses... 218 Coobservation ... 218 Integrated components (factory installed)... 218 CALLISTO eye ... 219
12.4
UC kits ... 219
13
Decommissioning ... 221
13.1 13.1.1
Cleaning before storage ... 221 Cleaning the device and accessories ... 221
14
Packaging and transport... 223
14.1 14.1.1
Preparing for transport... 223 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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Empty page, for your notes
Instructions for Use OPMI LUMERA 700
1 Notes on Instructions for Use 1.1 Device name
1 Notes on Instructions for Use 1.1 Device name OPMI LUMERA 700 is referred to as "device" in the present Instructions 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. u
Read these Instructions for Use before setting up and using the device the first time.
u
Keep the Instructions for Use accessible for all users at all times.
u
Pass the Instructions for Use to future owners of the device.
1.4 Questions and comments u
If 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.
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1 Notes on Instructions for Use 1.5 Conventions in this document
Instructions for Use OPMI LUMERA 700
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. u
CAUTION!
This is a measure with which hazards can be prevented.
This is warning information about hazards that can cause injuries if not avoided. The warning message names the possible consequences. u
NOTE
This is a measure with which hazards can be prevented.
This is warning information about hazards that can cause property damages if not avoided. The warning message names the possible consequences. u
This is a measure with which hazards can be prevented.
þ This 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. ð This is the result of a sequence of actions.
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Instructions for Use OPMI LUMERA 700
1 Notes on Instructions for Use 1.6 Other applicable documents
1.6 Other applicable documents
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Document type
Document title
Optional
Product overview
ZEISS Video Accessories
No
Instructions for Use
Preparation of Resterilizable 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 Yes Add-On for OPMI LUMERA 700 Control
Instructions for Use
CALLISTO eye - Software Add-On for VISALIS 500 Parameter Display
Yes
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Empty page, for your notes
Instructions for Use OPMI LUMERA 700
2 Safety notes 2.1 Target group
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 resterilizable 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 illumination 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 procedures 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.
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2 Safety notes 2.3 Responsibilities and duties of the operator
Instructions for Use OPMI LUMERA 700
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 resterilizable 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. u
Make sure that the operating personnel are appropriately trained and instructed.
u
Make sure that the operating personnel have read and understood the Instructions for Use.
u
Keep the Instructions for Use available at all times for the operating personnel.
u
To facilitate access for all operating personnel: Request additional copies of the Instructions for Use as required from ZEISS.
u
Specify the competencies for handling the device and state who is authorized to perform what tasks.
u
Determine the reporting obligations for malfunction and damage and make them known. Notification of the manufacturer and authorities. [} 17]
u
Provide the necessary protective clothing.
u
Regularly check that the legal regulations applicable in your country with regard to accident prevention and work safety are being complied with.
Safety inspections u
To 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. u
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Comply with the specified time limits.
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Instructions for Use OPMI LUMERA 700
2 Safety notes 2.3 Responsibilities and duties of the operator
u
Carry 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 u
To 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 u
WARNING: 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 u
If 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 requirements 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 requirements.
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.
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2 Safety notes 2.4 Measures and duties of the operator
Instructions for Use OPMI LUMERA 700
2.4 Measures and duties of the operator Electrical safety u
Always switch off the device before connecting it to or disconnecting it from the power supply, for cleaning its surface, or if it will not be used for a prolonged period of time.
u
Only connect the device to a power supply that complies with the values specified on the rating label.
u
Do not use multiple sockets!
u
Do not use extension cables!
u
Do not touch the device if your body is electrostatically charged and the device is not grounded.
u
Connect 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.
u
Please observe the information on electromagnetic compatibility (EMC).
The device contains freely accessible live components. If you remove the housing, you run the risk of electric shock. u
Never open the device!
Environmental conditions u
Make sure that the installation conditions and the operation of the device comply with the surgical requirements:
• Low vibration • Clean environment • Avoid extreme mechanical stress u
Do 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. u
Do not use or store the device in damp rooms. Do not expose the device to water splashes, dripping water or sprayed water.
u
Ensure that fluids cannot enter the device.
Symbols and labels u
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Note the symbols and labels attached to the device!
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2 Safety notes 2.5 Electromagnetic compatibility
Transport u
Only transport the device over long distances (e.g. relocation, return for repair) in its original packaging or special return packaging.
u
Please contact your dealer or ZEISS Service for this purpose.
2.5 Electromagnetic compatibility The device is subject to special requirements regarding electromagnetic 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 Instructions for Use and not sold by ZEISS as spare parts. You can prevent EMC disturbances by using the following precautionary measures: u
Please comply with the Instructions for Use.
u
Observe the EMC guidelines in the Technical Specifications chapter.
u
Only use accessories, transformers, cables and spare parts specified in the Instructions for Use or approved by ZEISS for this device.
u
If you are using radio communication equipment or components for radio transmission: Keep a distance of 30 cm to all components of the device.
u
If 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:
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u
Make sure that the connecting components are properly set and that all screw connections are securely tightened.
u
Make sure that all cables and plugs are in proper condition.
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2 Safety notes 2.6 Requirements for operation
Instructions for Use OPMI LUMERA 700
u
Make sure that the device is connected to an electrical outlet with a proper protective ground conductor.
u
Determine the supply voltage at the installation site and set the voltage of the device in accordance with the installation site's supply voltage.
u
Make 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: u
Check 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. u
If 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: u
Check the light source for visible damage.
u
Check the filter setting.
u
Switch 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:
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u
Never exceed the device's maximum permitted weight load.
u
Always route cables so that they do not hinder the user.
u
Never cover any ventilation openings. Doing so can cause the device to overheat and fail.
u
Never 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.
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