Storz VITOM EAGLE User manual

Instructions for use
VITOMEAGLE
en

Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of KARLSTORZSE&Co.KG.
All rights reserved.
05-2023

Table of contents
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 3
Table of contents
1 General information ......................................................................................................................... 5
1.1 Read the instructions for use ..................................................................................................... 5
1.2 Read the instructions for use of compatible products............................................................... 5
1.3 Scope......................................................................................................................................... 5
1.4 General signs and symbols........................................................................................................ 5
1.5 Description of warning messages.............................................................................................. 6
2 Normal use........................................................................................................................................ 7
2.1 Intended use .............................................................................................................................. 7
2.2 Indications.................................................................................................................................. 7
2.3 Contraindications ....................................................................................................................... 7
2.4 Clinical benefits.......................................................................................................................... 7
2.5 Residual risks ............................................................................................................................. 7
2.6 Target user populations ............................................................................................................. 7
2.7 Patient population ...................................................................................................................... 7
2.8 Intended conditions of use ........................................................................................................ 7
3 Safety and warning .......................................................................................................................... 8
3.1 Serious incidents........................................................................................................................ 8
3.2 Correct handling and product testing ........................................................................................ 8
3.3 Combination with other components......................................................................................... 8
3.4 Product not clean....................................................................................................................... 8
3.5 Dangers from electrical current.................................................................................................. 9
3.6 Patient leakage current .............................................................................................................. 9
3.7 Electromagnetic interference ..................................................................................................... 9
3.8 Appropriate combination of product and fiber optic light cable................................................ 9
3.9 Hot components ........................................................................................................................ 9
3.10 High light intensity...................................................................................................................... 9
3.11 Failure of products ..................................................................................................................... 10
4 Product description ......................................................................................................................... 11
4.1 Product overview ....................................................................................................................... 11
4.2 Possible combinations ............................................................................................................... 11
4.3 Symbols on the packaging ........................................................................................................ 12
4.4 Symbols on the product............................................................................................................. 13
4.5 Technical data............................................................................................................................ 14
4.6 Ambient conditions .................................................................................................................... 14
5 Preparation ....................................................................................................................................... 15
5.1 Unpacking the product .............................................................................................................. 15
5.2 Reprocessing the product ......................................................................................................... 15
5.3 Assembling the IMAGE1 PILOT ................................................................................................. 15
5.4 Connecting the VITOMEAGLE .................................................................................................. 16
5.5 Attaching sterile drapes ............................................................................................................. 17
5.6 Performing the white balance .................................................................................................... 19
6 Application ........................................................................................................................................ 20
6.1 Adjusting the horizon ................................................................................................................. 20
6.2 Controlling the optical functions ................................................................................................ 20

Table of contents
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 4
6.3 Selecting the region of interest .................................................................................................. 21
6.4 Function buttons on the VITOM EAGLE .................................................................................... 23
6.4.1 Preset functions............................................................................................................ 23
6.4.2 Programmable functions .............................................................................................. 23
6.5 Controlling the IMAGE1 S with IMAGE1 PILOT ......................................................................... 24
6.6 Function buttons on the IMAGE1 PILOT ................................................................................... 25
6.7 Setting image lighting ................................................................................................................ 26
6.7.1 Activating Fluorescein (FL)............................................................................................ 26
6.7.2 Activating Blue Light Imaging (BLI)............................................................................... 27
6.7.3 Activating ICG............................................................................................................... 27
6.8 PIP-Swap function ..................................................................................................................... 28
7 Disassembly...................................................................................................................................... 29
7.1 Disassembling the product ........................................................................................................ 29
8 Maintenance, servicing, repairs, and disposal .............................................................................. 30
8.1 Safety inspection in accordance with IEC 62353 ...................................................................... 30
8.2 Repairs to the product ............................................................................................................... 30
8.3 Disposing of the product ........................................................................................................... 30
9 Accessories and spare parts .......................................................................................................... 31
9.1 Accessories................................................................................................................................ 31
10 Electromagnetic compatibility ........................................................................................................ 32
11 Subsidiaries ...................................................................................................................................... 33

General information
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 5
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, and third parties may be injured or the
product may be damaged.
Read the instructions for use carefully and follow all the safety notes and warnings.
Read the reprocessing instructions carefully and follow all the safety notes and warnings. The
reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering the item
number.
Keep the instructions for use and reprocessing instructions in a safe place.
1.2 Read the instructions for use of compatible products
If the instructions for use of compatible products are not followed, patients, users, and third parties
may be injured or the product may be damaged.
Read the instructions for use of the compatible products carefully and follow all the safety notes
and warnings.
Read the reprocessing instructions of the compatible products carefully and follow all the safety
notes and warnings.
1.3 Scope
This instruction manual is valid for:
The 3D Exoscope with NIR/ICG, 5-ALA, and Fluorescein function
Product name Item number
VITOMEAGLE TH201
1.4 General signs and symbols
The signs and symbols used in this document have the following meaning:
Practical tip
This sign refers to useful and important information.
Actions to be performed
Action to be carried out by several steps:
üPrerequisite that must be met before carrying out an action.
1. Step 1
ðInterim result of an action
2. Step 2
ðResult of a completed action
Actions in safety notes or in the case of a single step:
Step 1

General information
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 6
Lists
1. Numbered list
– Unnumbered list, 1st level
– Unnumbered list, 2nd level
1.5 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warnings use the following levels of danger:
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
NOTICE
NOTICE
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
3D Exoscope with NIR/ICG, 5-ALA and Fluorescein function
The 3D Exoscope with NIR/ICG, 5-ALA and Fluorescein function is intended for white light and
fluorophore visualization of the surgical field in the visible and near-infrared spectral range during
diagnostic and surgical interventions. The 3D Exoscope with NIR/ICG, 5-ALA and Fluorescein function
does not have body contact.
2.2 Indications
Exoscopes are suitable for visualization during diagnostic and surgical interventions.
2.3 Contraindications
The medical devices are not used in body contact with the patient but generate images which can be
used for visualization during diagnostic and surgical interventions.
Furthermore, the medical devices must not be used for ophthalmologic interventions because
KARLSTORZ light sources are contraindicated in this specialty.
2.4 Clinical benefits
Exoscopes (2D exoscopes and 3D exoscopes) and the support components assist surgical
interventions by providing “heads up” display and ergonomic features to the surgeon, providing high
quality imaging which improve the work efficiency and patient safety. They are non-inferior to the
standard treatments with regards to outcomes and safety for the chosen medical indications.
2.5 Residual risks
No residual risks directly related to the product were identified.
2.6 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant specialist
qualification.
2.7 Patient population
There are no restrictions in terms of patient groups for this product.
2.8 Intended conditions of use
The product may only be used in hospitals and doctors’ offices in suitable ambient conditions, see
chapter Ambient conditions [p.14] and see chapter Electromagnetic compatibility [p.32].

Safety and warning
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 8
3 Safety and warning
WARNING
Danger due to non-observance of warnings and safety notes
This chapter contains warnings and safety notes structured according to hazards and risks.
1. Carefully read and observe all warnings and safety notes.
2. Follow the instructions.
3.1 Serious incidents
A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or could have
any of the following consequences:
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user, or
another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Correct handling and product testing
If the product is not handled correctly, patients, users, and third parties may be injured.
Only persons with the necessary medical qualification and who are acquainted with the
application of the product may work with it.
Check that the product is suitable for the procedure prior to use.
Check the product for the following properties, for example, before and after every use:
– Functionality
– Damage
– Changes to the surface
– In the case of several components: completeness and correct assembly
Do not continue to use damaged products.
Dispose of the product properly.
Do not leave broken-off components inside the patient.
Do not overload the product with mechanical stress.
Do not bend bent products back to their original position.
3.3 Combination with other components
The use of unauthorized devices and components may result in injuries.
Only combine the product with devices and components that the manufacturer has approved for
combined use, see chapter Possible combinations.
Do not make any modifications to the product.
3.4 Product not clean
The product is not clean when delivered. The use of products that have not been cleaned poses a risk
of infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and every
subsequent use.

Safety and warning
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 9
3.5 Dangers from electrical current
An improper power supply may cause an electric shock and injure patients, users, or third parties.
Do not use multiple socket outlets with this device.
If the use of a multiple socket outlet cannot be avoided: Only use a multiple socket outlet with an
isolation transformer in accordance with IEC 60601-1.
3.6 Patient leakage current
If several products supplied with energy are used simultaneously, the patient leakage currents of the
product can accumulate. Excessively high leakage current levels may result in the patient becoming
injured.
Only use products of the same type together, particularly if CF products are required.
If the product is connected to a type BF generator, the product will also correspond to type BF.
3.7 Electromagnetic interference
Medical electrical devices are subject to special precautions regarding electromagnetic compatibility.
If other devices (e.g., MRT, CT, diathermy, electrocautery, or RFID) emit electromagnetic radiation, the
product’s functionality may be impaired. High-frequency (HF) communication equipment can affect
electrical medical devices and impair their performance.
During installation and operation of the product, please take note of the information on
electromagnetic compatibility, see chapter Electromagnetic compatibility.
3.8 Appropriate combination of product and fiber optic light
cable
If the fiber bundle diameter of the fiber optic light cable is too large, the product will heat up at the
light connection. This may cause damage to the product.
If the fiber bundle diameter of the fiber optic light cable is too small, not enough light will enter the
product. This may mean that the operating area is not sufficiently illuminated.
Use the product with a fiber optic light cable that has an appropriate fiber bundle diameter; see
Possible combinations.
3.9 Hot components
The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users, or third
parties.
Set the output of the adjustable light sources to a level that is just high enough to ensure optimal
illumination of the operating area.
Avoid contact with the distal end of the exoscope.
The surface of the product can get hot. This can cause burns to patients, users, or third parties.
Do not hold the product for an extended period of time.
Use a holding system instead.
3.10 High light intensity
The high level of light intensity produced by the light source may lead to permanent eye damage or
blindness, and may cause tissue and items facing the light output to heat up.
Do not look into the light output.

Safety and warning
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 10
3.11 Failure of products
The product may fail during use.
Have a replacement product ready for each application or plan for an alternative surgical
technique.

Product description
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 11
4 Product description
4.1 Product overview
8
7
3
6
1
2
54
1 Function buttons 5 Connection for holding system
2 Release button for manual positioning 6 Power cord connection socket
3 Fiber optic light cable 7 Video cable
4 Cover glass 8 Aperture filter rotating wheel
4.2 Possible combinations
It is recommended that the suitability of the products for the intended procedure be checked prior to
use. Please note that the described products in this medium may not be available in all countries due
to different regulatory requirements.
CAUTION
Overload! Malfunction!
Make sure that devices attached to the exoscope do not exceed a weight of 1.5kg.
The product can be combined with the following components:
Camera Sys-
tem
Light Source Holding Sys-
tem
Router Sterile Drape Monitor
TC014
TC019
TC304
TC201
TL400
TL410
with 495VTE
UR500B
UR500C
UR400B
UR400C
UR007
WO10240 041130-10 TM350
TM450
Interface between telescope and light cable
If there is an identification symbol on light cables and exoscopes, the matching combinations should
be assigned according to the symbols shown. Special exoscopes may deviate from this.

Product description
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 12
Light cable diameter Symbol Endoscope diameter Symbol
2.0 mm ... 2.5 mm 0.8 mm ... 2.9 mm
3.0 mm ... 3.5 mm 3.0 mm ... 6.5 mm
4.8 mm ... 5.0 mm 6.6 mm ... 12.0 mm
4.3 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unique Device Identifier
Consult the printed or electronic instructions for use
Note for the user to consult the instructions for use for important cautionary in-
formation such as warnings and precautions.
Fragile, handle with care

Product description
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 13
Symbol Meaning
Keep dry
Federal (USA) law restricts this device to sale by or on the order of a physician.
CE marking
With this marking, the manufacturer declares the conformity of the product
with the applicable EU directives. A code number after the CE mark indicates
the responsible notified body.
The EU directives relevant to the product can be found in the EU Declaration
of Conformity, which can be requested from KARLSTORZ.
4.4 Symbols on the product
Symbol Meaning
Manufacturer
Data matrix code (example display)
Product information, e.g., UDI
Serial number
Light cable diameter
Article no.
Follow the instructions for use.
The color may differ on the product. The symbol is black/white on the packag-
ing label.
Type BF device
CE marking
With this marking, the manufacturer declares the conformity of the product
with the applicable EU directives. A code number after the CE mark indicates
the responsible notified body.
The EU directives relevant to the product can be found in the EU Declaration
of Conformity, which can be requested from KARLSTORZ.

Product description
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 14
4.5 Technical data
VITOMEAGLE
Description Value
Weight 4.5kg
Dimensions (WxHxL) 97x227x366mm
Max. temperature 48°C (118°F)
Requirements for a US power cord for external power supply
Description Value
Socket IEC60320C7
Connector NEMA1-15
Nominal dataUL/CSA 10A/125VAC;50/60Hz
Electric strength >2kVDCbetweenL-N
>2kVACbetweenL/N-PE
(1min/50Hz)
Permissible operating temperature -25°C...70°C (-13°F...158°F)
IP protection class FrontIP20according toIEC60529
4.6 Ambient conditions
Transport and storage conditions
Temperature -18°C...+60°C (-0.4°F...+140°F)
Relative humidity
(non-condensing)
0–85%
Air pressure 600–1,080hPa
Operating conditions
Temperature 5°C...35°C (41°F...95°F)
Relative humidity
(non-condensing)
5–85%
Air pressure 700–1,060hPa

Preparation
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 15
5 Preparation
5.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and possible damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and extent
and contact the manufacturer or supplier immediately.
4. Keep packaging for further transport.
5.2 Reprocessing the product
Reprocess the product in line with the reprocessing instructions before using it.
5.3 Assembling the IMAGE1 PILOT
The product is designed for use indoors, particularly in operating rooms and similar surgical or
clinical establishments.
The product is operated with the IMAGE1 PILOT (TC014).
1. Fasten the IMAGE1PILOT to the operating table using a KARLSTORZ articulated stand.
2. Position the IMAGE1PILOT in such a way that the control unit can be reached with ease.
3. Fasten the holding arm to the operating table and place in position.
4. Open the KSLOCK quick release coupling (female) on the articulated stand by turning it in the
“OPEN” direction.
5. Insert the KSLOCK quick release coupling (male) on the bottom of the IMAGE1PILOT until it
audibly clicks into place.

Preparation
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 16
6. Make sure that the IMAGE1PILOT has engaged.
7. Lock the KSLOCK quick release coupling (female) on the articulated stand by turning it in the
“CLOSE” direction.
8. Attach the USB cable of the control unit to a USB socket on the IMAGE1SCONNECTII.
ðThe message “IMAGE1PILOT connected” appears on the display.
ðThe LED indicating the function status lights up.
5.4 Connecting the VITOMEAGLE
Only connect intact cables. Connectors must be correctly connected in order to ensure that the
system functions properly. Always plug in connectors all the way. Do not use excessive force
when plugging in or removing the connectors. After plugging in the connectors, check the
connection. Keep the connection to the power supply accessible at all times.
1. Connect the power cord for the VITOMEAGLE to the power supply.

Preparation
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 17
2. Connect the fiber optic light cable to the VITOMEAGLE connection socket for fiber optic light
cables.
3. Insert the fiber optic light cable in the holder on the VITOMEAGLE.
4. Connect the fiber optic light cable to a light source.
5. Connect the video cable of the VITOMEAGLE to the camera control unit of the IMAGE1S.
5.5 Attaching sterile drapes
The VITOMEAGLE and the IMAGE1PILOT cannot be sterilized and must therefore be fitted
with a sterile drape for the duration of the procedure.
Have a second sterile drape ready.
1. Remove the sterile drape (041130-10) from its packaging.

Preparation
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 18
2. Unfold the sterile drape as indicated.
3. Pull the plastic frame of the sterile drape over the cover glass.
4. Pull the sterile drape over the VITOMEAGLE and the holding system.
5. Remove the sterile drape for the IMAGE1PILOT (041150-20) from its packaging.
6. Cover the IMAGE1PILOT control unit with the sterile drape.

Preparation
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 19
7. Ensure that the elastic insert on the tip of the sterile drape is placed directly over the
IMAGE1PILOT.
5.6 Performing the white balance
The white balance must be performed before every procedure.
Failure to perform proper white balance of system may result in color distortion.
1. Ensure that an imaging instrument is connected and a live image appears on the monitor.
2. Connect the light source to the imaging instrument via the light cable.
3. Point the VITOMEAGLE at a white and clean surface, e.g., white gauze.
4. Make sure that the light source emits enough light to sufficiently illuminate the surface.
ðThe monitor displays a completely white and well illuminated live image.
5. Press the White Balance button on the IMAGE1SCONNECTII or the button in the Live menu.
ðThe white balance is performed.
6. Check the monitor to see whether the white balance was successful.
7. Repeat the white balance if required.

Application
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 20
6 Application
6.1 Adjusting the horizon
The functions listed here may not yet be available in all countries due to differences in approval
requirements.
The VITOM EAGLE image is rotated around the center point. This enables flexible positioning of the
VITOM EAGLE and correction of the horizontal image alignment during the application.
1. Rotate the VITOMEAGLE about its axis.
ðThe image can be rotated by approx. 270°.
2. To rotate the image further, open the IMAGE1S menu and select the ImageFlip button.
3. To rotate the image 180°, select the >180° button.
ðA 360° image rotation is possible.
6.2 Controlling the optical functions
The IMAGE1PILOT can be used to control the optical functions of the VITOMEAGLE. Alternatively,
the microscope footswitch(TC019) can be used instead of controlling the optical functions of the
VITOMEAGLE using the IMAGE1PILOT.
Two IMAGE1PILOTs can be connected. This allows both operation from the sterile field by the
surgeon and also from the unsterile field by the assistant.
If the IMAGE1PILOT fails during the surgical procedure, it must be ensured that a replacement
system can be introduced within a reasonable timeframe.
Zoom
The VITOMEAGLE uses the optical zoom and digital zoom modes; the VITOMEAGLE zoom function
switches between these modes. When the VITOMEAGLE is using digital zoom mode, an overview
appears at the top right.
1. To magnify the image, push the 3D Wheel down.