Carl Zeiss
Other Clinical & Surgical Microscopes and accessories
KINEVO 900 Instructions for Use sw rel 1.8 Dec 2021
Instructions for Use
316 Pages
Preview
Page 1
KINEVO 900 Software Release 1.8
Instructions for use
Copyright © 2021, Carl Zeiss Meditec AG, Jena Brands ZEISS KINEVO 900 is a trademark or registered trademark of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries. All other brands mentioned in this document are the property of their respective owners.
Instructions for use KINEVO 900
Table of Contents
Table of Contents 1
Notes on the instructions for use ... 11
1.1
Product name ...
11
1.2
Scope 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 ... Conventions in all text areas... Conventions in a course of action...
11 11 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 2.2.3 2.2.4 2.2.5
Intended use ... Indications... Normal use... Possible damage/injury from burns due to the high light intensity ... Electromagnetic compatibility...
15 16 16 18 21
2.3
Responsibilities and duties of the operator ...
21
2.3.1 2.3.2
Requirements for the network connection... Messages to manufacturer and authorities ...
23 25
2.4
Measures and duties of the operator...
25
2.5
Liability and warranty...
26
3
Device description ... 27
3.1
General ...
27
3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6
Innovative functionalities ... Kinematic and robot-assisted positioning functions ... QEVO handheld Micro-Inspection Tool (option) ... Integrated 3D video system for observation without eyepieces (option)... Data management... Navigation functionality ... Video recording functionality (option) ...
27 27 28 28 29 29 30
3.3 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
Device marking... Labeling on the microscope... Approval label / UDI label ... Labeling on stand, Part 1... Labeling on stand, Part 2... Labeling on stand, Part 3... Labeling on stand base ... Labeling on light source ... Labeling for autofocus option... Labeling on packaging ...
30 31 32 33 35 37 39 40 41 42
G-30-2094-en - 1.4 - 2021-12-07
3 / 300
Table of Contents
Instructions for use KINEVO 900
3.3.10 3.3.11
Displaying radio frequency approvals on the monitor ... Display Windows EULA on the monitor ...
43 44
3.4 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5
Structure of the device ... Device overview ... Overview of connector panel... Overview of video connector panel ... Overview of video connector panel (4K 2D/3D option)*... Overview of microscope ...
45 45 46 48 50 51
3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9
Control elements and displays ... Screen keyboard... Display: Editing... Online help... Error messages on the monitor... Controls on the microscope... Controls of binocular tubes ... Controls for widefield eyepieces ... Controls of handgrips... 14-function foot control panel ...
57 57 57 58 59 60 61 62 63 64
3.6 3.6.1 3.6.2 3.6.3 3.6.4 3.6.5 3.6.6 3.6.7 3.6.8 3.6.9 3.6.10 3.6.11 3.6.12 3.6.13 3.6.14 3.6.15 3.6.16 3.6.17 3.6.18 3.6.19 3.6.20 3.6.21 3.6.22 3.6.23 3.6.24 3.6.25 3.6.26 3.6.27 3.6.28
Software description ... General ... Interactive buttons ... User interface of the KINEVO 900... QEVO user interface (option) ... Status Information... “Patient data” menu... Importing patient data from the DICOM Worklist ... “Edit video recording” menu ... SmartLinks... Light... Tube... Focus ... Zoom ... Hand Grips ... Foot Control Panel (FCP)... Rock Switch ... Suspension system ... Displays... Audio ... Photo ... Video Camera... Connections ... Video recording... Fluorescence ... MultiVision ... Info ... Extras ... Service PC ...
65 65 65 67 70 71 72 74 76 78 79 80 81 82 83 85 86 87 88 89 90 91 94 103 104 107 109 110 111
4
Installation ... 115
4.1
Requirements ... 115
4.2
Attaching the tubes and eyepieces ... 116
4 / 300
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
Table of Contents
4.3
Using an integrated 3D video system for observation without eyepieces (option)... 118
4.4
Attaching the documentation/co-observer facility ... 119
4.5
Mounting the mouth switch ... 121
4.6
Moving the device ... 122
4.7
Connecting the device to the power supply... 124
4.8
Switching the device on ... 126
4.9
Initial device login ... 127
4.10
Connecting the wired foot control panel or rocker foot switch ... 128
4.11
Pairing the wireless foot control panel with the device... 129
4.12 4.12.1 4.12.2 4.12.3 4.12.4 4.12.5 4.12.6
Connecting video systems and external monitors... 132 Connecting video devices ... 134 Connection of the 4K 3D monitor ... 134 Connection of the 4K 2D monitor ... 138 Connection of the HD 3D monitor... 141 Connection of the HD 2D monitor... 144 Connecting the monitor of a third-party manufacturer ... 147
4.13
Connecting USB storage media ... 147
4.14
Configure network ... 148
4.14.1 4.14.2 4.14.3 4.14.4 4.14.5 4.14.6 4.14.7 4.14.8
Activating IT admin system rights ... Activate network connection via LAN ... Activate network connection via wireless LAN (option)... Creating and activating the device as a hotspot... Activating the web interface in the device ... Network drive ... Configure the network connection for DICOM (option). ... Changing the computer name of the device ...
4.15 4.15.1 4.15.2 4.15.3
Configuring the Service PC ... 153 Service ... 153 Settings ... 153 Log Files ... 154
4.16
Connecting the navigation system to the device ... 155
4.17
Mounting the laser micromanipulators... 156
5
Daily startup... 159
5.1
Safety during preparation... 159
5.2
Setting the position of the handgrips ... 160
5.3
Positioning the device in the OR... 161
5.4
Check that the system can move freely! ... 161
5.5
Configuring the device for applications ... 162
5.6
Drape position ... 162
5.7
Attaching a ZEISS SMARTDRAPE... 163
5.8
Autobalance ... 165
5.9
Setting the microscope ... 166
G-30-2094-en - 1.4 - 2021-12-07
148 149 150 150 151 151 152 152
5 / 300
Table of Contents
Instructions for use KINEVO 900
5.10
Connect QEVO Micro-Inspection Tool (option)... 167
5.11
Activate QEVO Micro-Inspection Tool (option) ... 168
5.12
Activating a connection to the navigation system ... 168
5.13
Preparing the device for the use of laser micromanipulators... 169
5.14
Device function tests ... 171
6
Operation ... 173
6.1
Safety during operation... 173
6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.2.8 6.2.9 6.2.10 6.2.11
Software configuration... 175 Touchscreen... 175 Configure microscope ... 175 Configuring the button assignment of the hand grips, foot control panel and rocker foot switch 180 Configure stand... 184 Configure displays ... 193 Configure audio ... 193 Configuring Photo ... 194 Configuring the video camera ... 194 Configuring the video recording ... 196 Configure fluorescence... 197 Configure MultiVision... 199
6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7
Manage User ... 201 Adding a user... 201 Configuration of users ... 202 Export user settings to a USB storage medium... 202 Importing the user settings from a USB storage device ... 203 Changing user ... 203 Copy a user ... 204 Delete User ... 204
6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.4.9
Patient administration ... 205 Adding a patient ... 205 Changing patients ... 205 Edit patient data... 205 Searching for a patient ... 206 Sorting patients... 206 Export Patient Data ... 206 Importing patient data from the USB port or network ... 208 Importing patient data from the DICOM Worklist ... 209 Deleting patients ... 210
6.5
Recording video files (option) ... 210
6.6 6.6.1 6.6.2
Additional recording of video files on a USB storage medium or network drive (parallel recording) ... 213 Parallel recording of video files on a USB storage medium ... 213 Parallel recording of video files on a network drive... 213
6.7
Recording video files via SmartRecording... 213
6.8
Streaming video files ... 215
6.9
Taking photos with the integrated video camera ... 216
6.10
Taking photos with the DSLR camera (option) ... 218
6 / 300
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
Table of Contents
6.11 6.11.1 6.11.2 6.11.3 6.11.4 6.11.5
Patient data, photographs and videos... 219 Opening the patient directory... 219 Display of media objects (files)... 219 Viewing patient images ... 219 Viewing patient videos ... 220 Editing patient videos ... 221
6.12 6.12.1 6.12.2
DICOM (option)... 222 Importing patient data from the DICOM Worklist ... 223 Exporting patient data to DICOM ... 223
6.13 6.13.1 6.13.2 6.13.3 6.13.4 6.13.5 6.13.6 6.13.7 6.13.8
Use QEVO Micro-Inspection Tool (option)... 224 Switch QEVO on / off ... 224 Display QEVO user interface ... 225 Switching the automatic switch-off function on/off ... 226 Perform white balance ... 226 Setting the image brightness ... 227 Change QEVO alignment... 228 Show / hide marker ... 231 Switching the light on/off... 231
6.14
BLUE 400 (option)... 232
6.14.1 6.14.2 6.14.3
Configuring BLUE 400 ... 233 Carry out BLUE 400 functional inspection ... 234 Starting the BLUE 400 fluorescence application ... 235
6.15 6.15.1 6.15.2 6.15.3
YELLOW 560 (option) ... 235 Configuring YELLOW 560... 236 Procedure for YELLOW 560 function test... 237 Starting the YELLOW 560 fluorescence application... 238
6.16
Using the device as a hotspot... 239
6.17
Connecting an external device to the device via web interface (option) ... 240
6.18 6.18.1 6.18.2 6.18.3
Using ZEISS Smart Services... 241 Activating ZEISS Smart Services ... 241 Send Diagnostic Package... 241 Allow Remote Service Access ... 241
6.19
Powering the device down ... 242
7
Cleaning and disinfection ... 243
7.1
Safety during cleaning and disinfection... 243
7.2
Contamination of the system... 243
7.3 7.3.1
Cleaning and disinfecting agent ... 243 Cleaning agents... 243
7.4 7.4.1 7.4.2 7.4.3 7.4.4
Cleaning ... 244 Cleaning optical surfaces ... 244 Cleaning the monitor (touchscreen)... 244 Cleaning mechanical surfaces ... 244 Prevention of fogging... 245
7.5 7.5.1
Disinfection ... 245 Disinfecting the mechanical surfaces ... 245
G-30-2094-en - 1.4 - 2021-12-07
7 / 300
Table of Contents
Instructions for use KINEVO 900
8
Maintenance ... 247
8.1
Safety during maintenance... 247
8.2 8.2.1
Maintenance schedule for the operator... 247 User maintenance intervals... 247
8.3 8.3.1 8.3.2
Maintenance schedule for the authorized service... 248 Service maintenance intervals ... 248 Performance of safety inspections ... 248
8.4
Remote service ... 249
9
Troubleshooting... 251
9.1 9.1.1 9.1.2 9.1.3
Localize faults... 251 React to disruptions with notifications... 251 Export Log Files ... 251 Service information ... 251
9.2
Remote service ... 252
9.3
Malfunctions without notifications... 252
9.4
Basic Function Mode following system control failure ... 254
9.5
Device in the de-energized state... 255
9.6
Automatic lamp change... 255
9.7
Manual lamp change ... 256
9.8
Replacing the lamp container ... 257
10
Technical specifications... 259
10.1
Regulatory information ... 259
10.2
Radio Frequency Approval... 259
10.3
Radio modules... 259
10.3.1 10.3.2 10.3.3
Bluetooth module ... 259 WLAN module (option)... 260 RFID module... 260
10.4
Electrical data... 261
10.5
Light source... 261
10.6
Aiming beam laser... 262
10.7
Integrated HD camera ... 262
10.8
4K camera ... 262
10.9
Digital video outputs ... 262
10.10
Digital video inputs... 263
10.11
4K video outputs ... 263
10.12
Audio input ... 263
10.13 Mechanical data ... 263 10.13.1 System data ... 263 10.13.2 Dimensions of rollers ... 264
8 / 300
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
Table of Contents
10.13.3 Component weights... 264 10.14 10.14.1 10.14.2 10.14.3
Optical data... 265 Surgical microscope... 265 Widefield eyepiece (magnification factor 10x) ... 265 Widefield eyepiece (magnification factor 12.5x) ... 266
10.15
Ambient requirements for operation ... 266
10.16
Ambient requirements for transport and storage ... 266
10.17
Operation with intraoperative MRT systems ... 266
10.18
Dimensional drawing... 267
10.19 Guidelines and manufacturer’s declaration for electromagnetic compatibility ... 268 10.19.1 EMC - Electromagnetic compatibility as per IEC 60601-1-2: 2007 (3rd Edition) ... 268 10.19.2 EMC - Electromagnetic compatibility as per IEC 60601-1-2: 2014 (4th Edition) ... 272 10.20 10.20.1 10.20.2 10.20.3 10.20.4 10.20.5 10.20.6
Security Concept... 275 Objective... 275 System overview... 275 General principles... 276 Cybersecurity relevant functions ... 277 Ensure trusted system setup ... 282 Protection of critical device functionality ... 283
11
Accessories and components ... 285
11.1
Video components... 285
11.2
QEVO... 285
11.3
Components for hybrid visualization ... 285
11.3.1 11.3.2 11.3.3 11.3.4 11.3.5 11.3.6 11.3.7 11.3.8 11.3.9 11.3.10 11.3.11 11.3.12 11.3.13
Main tube ... Eyepieces for main tube ... Co-observer tube... Tube for left/right co-observation ... Eyepieces for left/right co-observation ... Tube for face-to-face... Eyepieces for face-to-face... Tube for posterior fossa... Eyepieces for posterior fossa ... Canon EOS DSLR Adapter Kit... Mouth switch... Magnification Changer ... Adaptation of laser micromanipulators ...
11.4
Tube covers ... 288
11.5
Fluorescence targets... 288
11.6
Foot control panel ... 288
11.7
FCP cable/FCP backup cable ... 288
11.8
Rocker foot switch ... 288
11.9
Sterile covers/drapes ... 289
11.10
Country-specific cables ... 289
11.11
Stereo glasses... 289
G-30-2094-en - 1.4 - 2021-12-07
285 286 286 286 286 286 287 287 287 287 287 287 288
9 / 300
Table of Contents
Instructions for use KINEVO 900
11.12
Medical loupes ... 289
11.13
Lamp container of the xenon light source ... 290
11.14
USB stick ... 290
11.15
USB memory medium ... 290
12
Disposal ... 291 Glossary ... 293 Index ... 295
10 / 300
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
1 Notes on the instructions for use 1.1 Product name
1 Notes on the instructions for use 1.1 Product name KINEVO 900 is referred to as "Device" in these Instructions for Use.
1.2 Scope of application The present instructions for use apply to KINEVO 900 with software release 1.8 and the following identification: •
Reference number: 6640
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 functioning. Action
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 Action
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: Conventions in this document [} 11]. This is highlighted text. This is software code or program text.
G-30-2094-en - 1.4 - 2021-12-07
11 / 300
1 Notes on the instructions for use 1.5 Conventions in this document
Instructions for use KINEVO 900
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.
Prerequisite
þ This is a requirement that must be met before the start of a sequence of actions.
Action
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.
12 / 300
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
1 Notes on the instructions for use 1.6 Other applicable documents
1.6 Other applicable documents
G-30-2094-en - 1.4 - 2021-12-07
Document type
Document title
Document number
Training record
Briefing report for newly installed systems
G-30-1714
User manual
INFRARED 800 with FLOW 800 Option
G-30-1956
User manual
Mouth switch (option)
G-30-1469
User manual
14-function foot control panel, wired (FCP) or wireless (FCP WL) (option)
G-30-1706
User manual
QEVO and QEVO ECU (option)
G-30-1976
Reprocessing instructions
QEVO
G-30-1989
User manual
Loupe EyeMag Pro S
G-30-1688
User manual
SMARTDRAPE
G-30-1996
Product overview
ZEISS Video Accessories
G-30-1888
Conformance statement
DICOM Declaration of Conformity
G-30-1952
License agreements
MICROSOFT SOFTWARE LICENSE accessible via TERMS for WINDOWS 10 IOT the device's ENTERPRISE & MOBILE user software
Release Notes
Release Notes for ZEISS KINEVO 900
RN-30-9063
13 / 300
Empty page, for your notes
Instructions for use KINEVO 900
2 Safety notes 2.1 Target group
2 Safety notes 2.1 Target group Only to be operated by trained personnel!
CAUTION!
These Instructions for Use are intended for physicians, nurses and other medical and technical staff who prepare, operate or maintain the device after appropriate training. It is the duty of the device owner/operator to train and brief all the operating personnel. u
Initial instruction in preparation, operation, warnings/hazards, emergency operation and transport of the device shall be provided according to Training record G-30-1714 in connection with the present Instructions for Use.
u
Any further training and instruction of planned operating personnel shall be performed by the operator of the device based on these Instructions for Use.
2.2 Area of use 2.2.1 Intended use The KINEVO 900 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures.
CAUTION!
Injury to the patient's eye! The device must not be used for ophthalmological procedures. u
Make sure that no xenon light and no laser radiation enters the patient's eyes.
Optional functionalities The BLUE 400 option is designed for a surgical microscope and can be used in tumor surgery to visualize tumor tissue marked with fluorescence dyes. The YELLOW 560 option is an accessory for the intraoperative illumination of the surgical area with light in the wavelength range from 460 nm to 500 nm. Light in the wavelength range between 540 and 690 nm is particularly highlighted.
G-30-2094-en - 1.4 - 2021-12-07
15 / 300
2 Safety notes 2.2 Area of use
Instructions for use KINEVO 900
2.2.2 Indications Information on the indication of use, contraindications and the target patient group is set out in the following table. Indication of use Discipline:
•
Neurosurgery and spine surgery
•
Orthopaedic surgery
•
Oral and maxillofacial microsurgery
•
P&R procedure
•
Not applicable for ophthalmology
Indication:
The ZEISS KINEVO 900 is a surgical microscope intended to illuminate and magnify the surgical area and to support visualization in surgical procedures.
Contraindication:
Provided that ZEISS KINEVO 900 is used within its indication of use, there are no known contraindications.
Patient target group:
No restriction
Age:
No restriction
Gender:
All
2.2.3 Normal use The complete system comprises a surgical microscope with a highly flexible floor stand containing the electronics, the light source, a graphic touchscreen with video display and an optional second monitor (2D or 3D). The stand supports the operation of the system in the following combinations: •
as an optical system
•
as a digital system
•
as a combined optical-digital ("hybrid"), robotic visualization system
The visualization system can use mono or stereo video functionalities combined with or without optical observation (tubes/ eyepieces). ZEISS KINEVO 900 is ideally suited for cranial and spinal applications in neurosurgery as well as ENT applications in the area of the auditory nerve and the base of the skull. Further fields of application include P&R procedures and oral and maxillo-facial surgery. The system is also ideally suited to multidisciplinary use in microsurgery. It is also designed for surgical interventions in which an endoscope and a surgical microscope are used at the same time, particularly with its microvisualization tool which can be added as an optional extra
16 / 300
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
2 Safety notes 2.2 Area of use
and simply plugged into the system so that the surgeon can detect hidden details or "see around the corner". The system is equipped for the connection of navigation systems, intraoperative neuromonitoring systems and for the data communication with external network systems. Optional fluorescence modules enable a better visualization of tumor and healthy tissue as well as better vascular visualization. The system is intended for use in hospitals, clinics or other medical facilities. The functions of the surgical microscope (OPMI) and the stand are controlled via the central control unit in the console. The interactive graphic touchscreen enables the user to configure all necessary settings. The user may trigger these functions using the buttons on the handgrips or on an optional foot control panel. The system may be operated only by physicians, nurses and other medically trained OR staff who have received appropriate training and observe the instructions for use. The installation conditions and the use of the system must meet microsurgical requirements:
G-30-2094-en - 1.4 - 2021-12-07
•
Low vibration
•
Dust-free environment
•
Level, horizontal positioning
•
Avoidance of extreme mechanical stress
•
EMC-specific environment based on a professional healthcare facility (use of RF surgical devices in combination with the microscope)
17 / 300
2 Safety notes 2.2 Area of use
Instructions for use KINEVO 900
2.2.4 Possible damage/injury from burns due to the high light intensity
CAUTION!
Tissue damage and burns at high light intensity! A high light intensity over a longer period of time can damage tissue and cause burns in the area of the illuminated surgical field. u
Read and observe the factors which can increase the risk of burns described below.
u
Read and observe the recommendations on how you can reduce the risk of burns.
u
Make sure that the "Focus Light Link" function is always switched on. ð The "Focus Light Link" function limits the maximum adjustable light intensity in the focal plane depending on the working distance. Possible tissue damage due to an unintentional high light intensity can thus be avoided. This function should only be deactivated if a higher light intensity is required for the current application.
General •
The device is equipped with a powerful xenon illumination.
•
If used improperly, excessive illumination intensities may lead to third-degree burns.
•
A device with light source switched on must never be left unattended.
Various factors contribute to the risk of burn injuries: System-related factors •
18 / 300
If a high magnification is used, the diameter of the field of view and the light intensity at the surgeon's eye and on the integrated cameras both decrease whereas the light intensity in the surgical field remains the same. This effect is increased by the use of certain components, such as e.g. eyepieces with higher magnification or the foldable tube f170/f260 with tube magnification (PROMAG function). When working at maximum magnification, you should therefore pay particular attention to the set light intensity to prevent burns, especially of the surrounding tissue.
G-30-2094-en - 1.4 - 2021-12-07
Instructions for use KINEVO 900
2 Safety notes 2.2 Area of use
Surgery-related factors •
The size of the luminous field influences the risk of injury in two respects: With a large luminous field diameter, areas of the skin are illuminated which are not monitored as strictly by the surgeon and which are not moistened sufficiently. These areas are particularly at risk of injury. These injuries can be prevented by adjusting the illuminated-field diameter to the smallest size required for the relevant operation.
•
If the luminous field is reduced in size, the intensity increases because the light is focused more. So, if possible, the intensity should be lowered as soon as the size of the illuminated field is reduced. The device can optionally be equipped with Automatic Light Field Limitation.
•
A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual.
•
Injuries in the peripheral area can be prevented by covering this area with moist, sterile gauze. Moisten the gauze at regular intervals to prevent the area from drying out or heating up. The risk is increased if dry drapes are used to cover such areas.
•
Some areas of the patient's body may be more sensitive than others.
•
Certain preparations of the surgical field, local vasoconstrictive medications and drapes at the wound edge may also result in a higher risk of injury (drapes may heat up to varying degrees depending on their color and moisture content).
•
When working in deep channels, the working distance from the illuminated wound edges is shorter than the distance from the actual surgical field. If you increase the light intensity to better illuminate a deeper surgical field, the risk of burns increases for the wound edges.
Patient-related factors
G-30-2094-en - 1.4 - 2021-12-07
•
The general condition of a patient's health may contribute to the risk of injury.
•
The skin type may be decisive for the risk of burns or injuries caused by light.
•
Certain medications (e.g. light sensitizing substances) also affect the sensitivity to light.
•
The interaction of heat and antimicrobial substances in incision foils may lead to an increased reaction of the patient to these substances.
19 / 300
2 Safety notes 2.2 Area of use
Instructions for use KINEVO 900
Recommendations
20 / 300
•
Make sure that the "Focus Light Link" function is switched on. The "Focus Light Link" function limits the maximum adjustable light intensity in the focal plane depending on the working distance. Possible tissue damage due to an unintentional high light intensity can thus be avoided. This function should be deactivated temporarily at most and only if a higher light intensity is required for the current application. Therefore, please note the recommendations for preventing burns.
•
The initial illumination intensity should be preset to a low value.
•
If used, drapes should also be remoistened at regular intervals in order to prevent heat from accumulating underneath the drape.
•
The risk of burns can be reduced by constantly irrigating the illuminated surgical field and by keeping it moist.
•
Using the buttons on the hand grip or foot control panel, the surgeon can set the illumination intensity to the value required for the procedure. Please note that the intensity increases with decreasing luminous field size if the spot function is used. For this reason, the intensity should be set only after the size of the illuminated field has been changed.
•
The device features an "Automatic Light Field Limitation" which should not be turned off.
•
Reduce the luminous field diameter when working in deep channels, so that the wound edges are not illuminated at a high light intensity wherever possible.
•
If the magnification factor is increased during surgery, the light intensity on the observer's side decreases. For balancing, the illumination intensity must be increased. This loss in image brightness is automatically compensated if the "Auto Brightness" function is activated.
•
Never leave a device unattended when its light source is switched on.
•
Switch off the light when the microscope is not being used, and ensure it is not directed at unprotected bare skin.
G-30-2094-en - 1.4 - 2021-12-07