Braun Aesculap Aeos Manual

AESCULAP®
USA Instructions for use/Technical description
Aesculap Aeos – Digital Surgical Microscope
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Aesculap, Inc. - Document No.: TA015615 - Version: 6.0 - Document ID: SOP-AIC-5001887 - Effective Date: 2022-10-06 - Status: Effective

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Aesculap, Inc. - Document No.: TA015615 - Version: 6.0 - Document ID: SOP-AIC-5001887 - Effective Date: 2022-10-06 - Status: Effective

USA
AESCULAP®
Aesculap Aeos – Digital Surgical Microscope
Legend
13D surgical screen
2Control screen
3Robotic arm
4Camera
5Base
6Footswitch
7Warranty seal
The illustrations in these instructions for use (especially illustrations of
the software) may deviate from the actual device.
Contents
1. About this document 3
1.1 Scope 3
1.2 Safety messages 3
2. Clinical use 3
2.1 Product description 3
2.1.1 Robotic arm 3
2.1.2 Camera 4
2.1.3 Base 4
2.1.4 3D display (optional) 6
2.1.5 3D display stand (optional) 6
2.1.6 Footswitch PV014 6
2.1.7 Keyboard 7
2.1.8 Polarized 3D glasses 7
2.1.9 Additional components 7
2.2 Areas of use and limitations of use 7
2.2.1 Intended use 7
2.2.2 Indications for use 7
2.2.3 Contraindications 7
2.2.4 Warnings 7
2.2.5 Essential performance 7
2.3 Safety information 8
2.3.1 Clinical user 8
2.3.2 Product 8
2.3.3 Sterility 9
2.4 System set-up 9
2.4.1 3D display and robotic arm workspace 10
2.4.2 Connecting the power supply 11
2.5 Functional test 11
2.6 Application 11
2.6.1 Positioning the 3D display 11
2.6.2 Turning the system on 12
2.6.3 Enable footswitch 12
2.6.4 Setting up the robotic arm and the camera 12
2.6.5 Starting a case 14
2.6.6 Taking videos and snapshots of live view 14
2.6.7 Ending a case 14
2.6.8 Saving case media 14
2.6.9 Removing the drape 15
2.6.10 Shutdown procedure 15
2.6.11 Putting out of operation 15
2.6.12 Changing footswitch batteries 16
3. Software 16
3.1 Home screen 16
3.2 Setup 16
3.2.1 Preset positions 16
3.2.2 Rebalance scope 17
3.2.3 Robot Recovery 17
3.3 Live screen 17
3.4 Control panel 18
3.4.1 Camera 18
3.4.2 Robot 19
3.4.3 Setup 20
3.4.4 Waypoints 20
3.5 Quick Access Bar (QAB) 20
3.5.1 Autofocus 20
3.5.2 Image modes 21
3.6 Software settings 21
3.6.1 Camera settings 21
3.6.2 Screen Layout 21
3.6.3 Digital Aperture 22
3.6.4 DUV 400 (Fluorescence) 22
3.6.5 Color 22
3.6.6 Recording 22
3.6.7 Display 23
3.6.8 Input Source 24
3.6.9 DICOM 24
3.6.10 Handles 24
3.6.11 Footswitch 25
3.6.12 About 26
3.7 Robotic arm state indicators 27
3.8 Robot malfunction 28
4. Troubleshooting 28
4.1 Malfunctions 28
4.2 Error messages in the software 29
5. Reprocessing procedure 30
5.1 Single-use products 30
5.2 Reusable products 30
5.3 Preparation before cleaning 30
5.4 Product-specific safety instructions for the reprocessing
procedure 30
5.5 Wipe disinfection 31
5.6 Inspection 31
5.6.1 Visual inspection 31
5.6.2 Functional test 31
5.7 Packaging 31
5.8 Storage and transport 31
6. Security 32
7. Maintenance and service 32
7.1 Maintenance 32
7.2 Technical Service 32
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8. Disposal 32
9. Technical data 33
9.1 Classification acc. to Directive 93/42/EEC and Regulation (EU)
2017/745 33
9.2 Performance data, information about standards 33
9.3 Voltage selector setting 33
9.4 Safe working load 33
10. Symbols on product and packaging 33
11. Distributor in the US/Contact in Canada for product
information and complaints 34
1. About this document
Note
General risk factors associated with surgical procedures are not described
in these instructions for use.
1.1 Scope
These instructions for use apply for the following products:
1.2 Safety messages
Safety messages make clear the dangers to patient, user and/or product
that could arise during the use of the product. Safety messages are
labeled as follows:
DANGER
Indicates a possible threat of danger. If not avoided, death or serious
injury may result.
WARNING
Indicates a possible threat of danger. If not avoided, minor or moder-
ate injury may result.
CAUTION
Indicates a possible threat of material damage. If not avoided, the
product may be damaged.
2. Clinical use
2.1 Product description
The Aesculap Aeos is a freestanding, digital surgical microscope in a look-
over configuration. The Aesculap Aeos does not utilize traditional micro-
scope binoculars within the field of use and is intended to be an alterna-
tive to traditional optical microscopes. The Aesculap Aeos software is a
component of the medical device.
The main components of the Aesculap Aeos system are:
■3D surgical screen 1– live surgical view
■Control screen 2– control interface
■Robotic arm 3
■Camera 4– 3D camera, illumination, and handle controls
■Base 5with embedded computers
■Footswitch 6
■Visualization software
■Sterile drape
Note
The essential performance feature is defined by the “robotic arm” specifi-
cations.
2.1.1 Robotic arm
The robotic arm is a six-jointed arm that supports the camera. Its touch-
guided movement allows the user to manipulate it through the work-
space. The robotic arm may be controlled via the handles, footswitch, or
control screen. On the 3D display, the robot state indicator shows the cur-
rent state of the robotic arm. The robotic arm workspace is illustrated
below.
Fig.1
Legend
aMax. radius
Art. no. Designation
PV008 26” Full HD 3D Monitor
PV010 Aesculap Aeos (Digital Surgical Microscope)
PV011 Upgrade kit for the integration of a 3D monitor
PV014 Aesculap Aeos foot switch wireless (including batter-
ies)
PV022 Software module DUV 400
PV023 Software module DIR 800
PV024 Software module DICOM
PV030 White balance card
PV031 Keyboard
PV032SU DUV 400 reference card
PV033SU DIR 800 reference card
PV012SU Aesculap Aeos sterile drape
425 mm
390 mm
a = 1,24 m
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2.1.2 Camera
The camera contains two sets of optics and two high-resolution sensors
to convert the analog signal to a digital video stream.
Fig.2
Legend
aBottom of camera
bMin. working distance
cMax. working distance
Camera LED indicator
The camera has an LED indicator on the back panel. The indicator colors
are explained below.
Handle buttons (default setting)
The Aesculap Aeos is designed to be controlled primarily through the but-
tons on the handles of the sides of the camera. The default layout of the
handles is shown below. In the software Handles settings, the handle but-
ton commands can be customized.
Fig.3
Legend
2.1.3 Base
Emergency stop
The robotic arm emergency stop is located at the top of the base. The
robotic arm movement is always under the control of the operator.
►If there is a malfunction and the robotic arm moves in an unintended
way, first attempt to press the soft stop button on the control
screen.
►If the control screen does not respond, use the emergency stop to
remove power from the arm and cease all movement.
Note
When the emergency stop is pressed, the camera may move up to 3 cm
(depending on position) due to mechanical brakes locking into place.
Base LED indicators
There are three LED indicators near the bottom of the base that display
the status of the camera, system computer (EPU), and robotic arm com-
ponents. The indicator colors are explained below.
Control screen
The system can be controlled by using the control screen. The control
screen is 2D only and not sterile.
►Position the control screen for quick and convenient access.
Isolation transformer
The system contains a medical-grade isolation transformer to ensure
patient and product safety. The transformer is configured by a service
technician to accept the required voltage from the alternating current
supply mains.
Indicator Description
Blinking blue The camera is starting up
Solid green The camera is ready for use
Solid yellow A minor error has occurred. See software mes-
sage for details.
Solid red A major error has occurred. User should switch
to a backup system immediately
425 mm
390 mm
a
b = 200 mm
c = 450 mm
425 mm
390 mm
b
= 2
0
0
m
m
c
= 4
50
m
m
a
b
c
d
e
f
g
h
i
j
k
L
l
m
l
n
o
p
q
r
s
t
u
v
R
a
b
c
d
e
f
g
h
i
j
k
Assisted drive
Zoom +
White light +
Focus -
Auto focus
White light -
Zoom -
Assisted drive
Image Mode (Next)
Focus +
Image Mode (Previous)
l
m
n
o
p
q
r
s
t
u
v
Move up
Move left
Move down
Assisted drive
Move forward
Way point save/delete
Move right
Lock-on mode
Waypoint select/move
Move backward
Assisted drive
Indicator Description
Camera:
Green The camera is powered on.
Red The camera is powered off / power failure.
Off The system is powered off.
System computer (EPU):
Green The EPU is powered on.
Red The EPU is powered off / power failure.
Off The system is powered off.
Robotic arm:
Green The robotic arm is functional.
Orange The robotic arm is booting.
Red The robotic arm is powered off / power failure.
Off The system is powered off.
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Uninterruptible Power Supply (UPS)
The system contains an uninterruptible power supply (UPS) which is con-
nected to the isolation transformer. By that means, components such as
the Aesculap Aeos computers, robotic arm, 3D display and control screen
are safely powered.
The UPS is able to buffer the Aesculap Aeos system for at least 5 seconds
in the case of an external power interruption.
If no case is started, the system will shut down after 2 minutes without
mains power. If a case is started the system will be provided with power
until the batteries are empty, which.depends on factors like the charging
state of the batteries.
The UPS is not designed to be used as a replacement for a mains power
connection.
►While in use, do not deliberately disconnect system from mains power.
Base connections
Fig.4
On the control screen arm, there are the following connections:
Note
Depending on the system configuration it could be that only one of the DP
Ports (c/h) can be used and the other one is covered by a blind cover.
The service technician will check with the operator during system installa-
tion to determine which one to use.
DANGER
Risk of injury due to unapproved configuration using additional com-
ponents!
►Make sure that all configurations comply with basic standard
IEC/DIN EN 60601-1 requirements for ME-systems. Any individ-
ual connecting devices with one another is responsible for such
configuration and must ensure compliance with basic standard
IEC/DIN EN 60601-1 or applicable national standards.
Combinations of accessories that are not mentioned in the present
instructions for use may only be employed if they are specifically intended
for the respective application, and if they do not compromise the perfor-
mance and safety characteristics of the products.
Also note that any equipment connected at the connections must demon-
strably meet the respective IEC standards (e.g. IEC 60950 for data pro-
cessing equipment, IEC/DIN EN 60601-1 for electromedical devices).
►Please address the B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact address, see
Chapter 7.2
►Every time a new piece of equipment is added and cables are con-
nected to the Aesculap Aeos system, power down the system prior to
connecting cables, then power it back up once the cables are con-
nected.
Connecting a video stream from another device (input)
Video streams from other devices may be connected to facilitate display
in conjunction with the 3D image from the camera.
The following device is approved for providing video input:
►Connect the device to the SDI input port iat the front of the base, see
Fig.4.
►Configure the video input in the Aesculap Aeos software “Input
Source” settings panel, see Chapter 3.6.8.
Connecting to a potential equalization system
Directly above the main power cord connection j, the Aesculap Aeos sys-
tem is equipped with a 6 mm potential equalization pin jthat can be con-
nected to the healthcare facility potential equalization system.
►Connect the healthcare facility potential equalization system to the
potential equalization pin jat the front of the base, see Fig.4.
Connecting to a PACS/RIS server
There are two Ethernet ports on the both the front and back panels of the
base.
►Ensure that the Ethernet cable and connector comply with at least
Cat-5e EIA/TIA-568A-5, preferably Class D values from ISO/IEC
11801:2002 or EN 50173-I:2002.
Note
Power over Ethernet (PoE) is not allowed.
►Connect an Ethernet cable to one of the Ethernet ports bor eto link
the system with the facility PACS server, see Fig.4.
►Configure the connection in the software DICOM settings. See
TA015615-DCS for the complete DICOM Conformance Statement.
Reference Port Connect to
aUSB 3.0 Keyboard, storage device
b, fEthernet Clinical network
c, hDisplay Port External monitor
dHDMI (output) External monitor
eUSB 2.0 Storage device
gHDMI (input) (not used)
iSDI Video source
j6 mm potential
equalization pin
Potential equalization system
kMains power cord
connection
Mains socket outlet
a
b
f
c
h
d e
g i j k
Art. no. Designation Connection Cable
PV480 2D camera platform BNC Cable
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2.1.4 3D display (optional)
The 3D display has a circularly-polarized, micro-polarizing filter that dis-
plays the right and left image alternately. Circularly-polarized glasses are
worn to ensure that the left eye only sees the left image and the right eye
only sees the right image. The display is set up by your Aesculap represen-
tative for optimal visualization.
►If the display settings are causing inadequate visualization, please
contact customer support for assistance.
Connecting a secondary display (output)
The system can support simultaneously displaying the live view on multi-
ple displays.
The following 3D displays are recommended for use with the
Aesculap Aeos:
►Connect the display to the DisplayPort output port crespectively to
HDMI dat the back of the base or hat the front of the base, see Fig.4.
►Configure the additional displays in the Aesculap Aeos software “Dis-
play” settings panel, see Chapter 3.6.7.
The individual display settings are specially configured at the factory.
When this function is activated, the power indicator flashes in amber. It
is not recommended to drape the displays.
►If two external displays in addition to the central 3D monitor PV008
should be connected, contact Aesculap Technical Service, see
Chapter 7.2.
2.1.5 3D display stand (optional)
The system can support remote 3D displays on a display stand approved
by Aesculap. If the default 26” 3D display does not come with the system,
an optional display can be the primary display.
The following display stands are approved for use with the Aesculap Aeos:
2.1.6 Footswitch PV014
The system can be controlled by using the wireless footswitch. The foot-
switch is uniquely paired with the Aesculap Aeos system in the
Aesculap Aeos software “Footswitch” settings panel, see Chapter 3.6.11.
Default footswitch button functionality
Fig.5
Legend
The footswitch button commands can be customized in the
Aesculap Aeos software “Footswitch” settings panel, see Chapter 3.6.11.
Footswitch status LEDs
Art. no. Designation Connection cable
PV008 26” display DisplayPort to DVI
PV644 31” 4K display HDMI / DP-HDMI
PV648 32” display DisplayPort to DVI
PV015 55” 4K display HDMI / DP-HDMI
Art. no. Designation
PV016 Mobile monitor stand for 55" monitor
PV818 Mobile monitor stand for 26" to 32" monitors
a
b
c
d
e
Waypoint save/delete
Auto focus
Focus -
Zoom -
White light -
f
g
h
i
j
Waypoint select/move
Lock-on mode toggle
Focus +
Zoom +
White light +
Symbol State Designation
Connection
Solid
green
Radio connection established, footswitch
engaged
Blinking
green
No radio connection, e.g. radio range error
or receiver not online
Blinking
red
Warning: possible loss of connectivity
Pairing mode active for ≈ 30 s; user action
required
Follow pairing instructions, see
Chapter 3.6.11.
Off Footswitch in power save mode
Battery
Solid
orange
Warning 1: “Battery low”
Battery voltage = 3.3 V to 3.2 V (± 10 %)
Blinking
orange
Warning 2: “Battery low”
Battery voltage ≤ 3.2 V (± 10 %)
Fast blink-
ing orange
Battery is empty: No further operation is
possible.
Battery voltage < 3.0 V (± 10 %)
Off Depending on Connect LED:
Connect LED ON: Battery voltage > 3.55 V
Connect LED OFF: Footswitch in sleep mode
a
b
c
d
e
f
g
h
i
j
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2.1.7 Keyboard
The system includes a keyboard with an integrated touchpad.
The keyboard is intended to be connected to the system via an USB inter-
face.
►Preferably connect the keyboard via the mast USB interface
►Only use the enclosed keyboard PV031 (US english layout), as the input
of country-specific character sets is not supported by the software.
2.1.8 Polarized 3D glasses
Passively, circularly-polarized glasses are needed to see the display in 3D.
The glasses may be worn over prescription glasses. Keep the glasses clean
and free of scratches. To ensure optimal image quality, the system should
only be used with Aesculap-supplied 3D glasses. Polarized prescription
glasses will distort the 3D effect and should not be used.
►Contact Aesculap if additional pairs are required.
The following 3D glasses are approved for use with the Aesculap Aeos:
2.1.9 Additional components
The Aesculap Aeos system comes with additional components to help
configure the system to work best in the operating room.
Aesculap doesn’t provide a sterile drape for the base. If required, the ster-
ile drape should meet the following recommendations:
2.2 Areas of use and limitations of use
2.2.1 Intended use
This device is for use with patients undergoing microsurgery within its
indications for use. The fluorescence functions of the Aesculap Aeos are
intended only for patients undergoing a procedure where the appropriate
fluorescent dyes and treatments are being used.
There is no patient contact intended with this device.
2.2.2 Indications for use
Note
The manufacturer is not responsible for any use of the product against the
specified indications and/or the described applications.
The Aesculap Aeos (Digital Surgical Microscope) generates a magnified
3D view of the surgical field.
Software module DUV 400 PV022
The DUV 400 is an accessory for the Aesculap Aeos and is used for viewing
fluorescence of fluorophores, comprising:
■An excitation filter for blue spectral range between 390 nm and
420 nm
■An observation filter for visible light with spectral range greater than
510 nm
Software module DIR 800 PV023
The DIR 800 is an accessory for the Aesculap Aeos and is used in viewing
intra-operative blood flow in the cerebral vascular area including, but not
limited to, assessing cerebral aneurysm and vessel branch occlusion, as
well as patency in neurosurgery. It also aids in the visual assessment of
intraoperative blood flow and vessel patency in bypass surgical proce-
dures in neurosurgery.
2.2.3 Contraindications
The Aesculap Aeos system must not be used for ophthalmology.
2.2.4 Warnings
Warnings include, but are not limited to, medical and/or surgical condi-
tions that could prevent the success of the procedure.
In the presence of warnings, the user decides individually regarding the
use of the product.
2.2.5 Essential performance
Prevent unintended and unprecise movement of robot arm while robot is
in movement.
Art. no. Designation
PV621 3D polarization glasses
PV622 3D anti-fog glasses
PV623 3D polarization glasses with clip
PV624 3D eye shield glasses kit
Art. no. Designation Function
FS095 Mains cord
orange angled
Switzerland
FS096 Europe
FS097 Great Britain and Ireland
FS098 Mains cord black
angled
Japan, USA, Canada
GK537 Equipotential
bonding lead 5 m
Connecting the device to the poten-
tial equalization system of the room
PV030 White balance
card
White-balancing the camera image
sensors. The reverse side of the card is
used by the technical service.
PV032SU DUV 400 refer-
ence card
For checking the functionality of the
DUV 400 imaging module (optional).
Single use only for accuracy check
PV033SU DIR 800 reference
card
For checking the functionality of the
DIR 800 imaging module (optional).
Single use only for accuracy check
PV034 HDMI cable 5 m Cable for connecting an external
monitor
PV035 HDMI cable 10m Cable for connecting an external
monitor
PV052 DP-HDMI cable
5m
Cable for connecting an external
monitor
PV053 DP-HDMI cable
10m
Cable for connecting an external
monitor
PV057 BNC cable 5 m Cable for connecting an endoscope
video input device
PV056 DisplayPort - DVI
cable 5 m
Cable for connecting an external
monitor
TA015635 Lens cap Protecting the lens of the camera
when it is being stored
Minimum height 30 cm
Maximum height 75 cm
Minimum width 70 cm
Maximum width 115 cm
Additional recommenda-
tions
■Must not hang over the castors
■Must not cover the base vents
Art. no. Designation Function
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2.3 Safety information
2.3.1 Clinical user
General safety information
CAUTION
Federal law restricts this device to sale by or on order of a physician!
To prevent damage caused by improper setup or operation, and to not
compromise the manufacturer warranty and liability:
►Use the product only according to these instructions for use.
►Follow the safety and maintenance instructions.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge and experience.
►Store any new or unused products in a dry, clean, and safe place.
►Prior to use, check that the product is in good working order.
►Keep the instructions for use accessible for the user.
Note
The user is obligated to report all severe events in connection with the pro-
duct to the manufacturer and the responsible authorities of the state in
which the user is located.
Notes on surgical procedures
It is the user's responsibility to ensure that the surgical procedure is per-
formed correctly.
Appropriate clinical training as well as a theoretical and practical profi-
ciency of all the required operating techniques, including the use of this
product, are prerequisites for the successful use of this product.
The user is required to obtain information from the manufacturer if there
is an unclear preoperative situation regarding the use of the product.
2.3.2 Product
Product-specific safety information
Risk of fatal injury from electric shock!
►Do not open the product.
►To avoid the risk of electric shock, only connect this equipment to a
supply mains with protective earth.
►Never connect the product using a multiple socket-outlet.
►Observe “Notes on electromagnetic compatibility (EMC) for the Aes-
culap Aeos (Digital Surgical Microscope) PV010” TA015615-EMV, see
B.Braun eIFU at eifu.bbraun.com.
►To prevent damage caused by improper setup or operation, and in
order not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►Always adhere to applicable standards.
►Set up and connect any external video input or output before the sys-
tem is turned on.
►Ensure that exposed cables for the footswitch, camera, any external
displays, and power supply are laid flat on the ground and out of high-
traffic areas to minimize potential tripping hazards.
►Do not use the robotic arm as an armrest or to support any unapproved
accessories. Do not place other equipment on the system.
►Do not place objects around or on top of the E-stop or on the camera
and arm.
►Prior to starting a case, unplug any USB devices (i. e. keyboard, exter-
nal hard drives) from external USB ports.
►Ensure the E-stop is not locked prior to surgery.
►Use the soft stop on the control screen if there is unintended robot
arm movement.
►Use the E-Stop only if the soft stop malfunctions.
►Check fluorescence functionality prior to surgery using the provided
reference card.
►Ensure that the camera working distance is between 20 cm and 45 cm.
►The fluorescence reference card and the control screen are not sterile.
Perform fluorescence functional tests before surgery.
►Take precautions to avoid touching any system components and the
patient at the same time.
►Do not push or pull the product by the display, camera, or power cable.
►To ensure optimal image quality, only use product with 3D glasses
supplied by Aesculap. Contact Aesculap if additional pairs are
required.
►Do not use polarized prescription glasses as they will distort the 3D
effect.
►Always return the robot to storage position before shutdown.
►Store the camera with the lens cap covering the main objective when
it is not in use.
►Do not cover the air vents of the system, control screen, or 3D display.
►Make sure that in case of a system failure or other malfunctions that
prevents further use of the system, the user is able to finish the pro-
cedure using a reserve system (e.g. traditional optical microscope).
Note
When the emergency stop is pressed, the camera may move up to 3 cm
(depending on position) due to mechanical brakes locking into place.
Light emission risks
Retinal blue light and Near-UV emission risk.
►Do not stare at the lamp emission area during operation.
►Minimize exposure to eyes and skin.
►Use appropriate shielding.
►Make sure that no light from the Aesculap Aeos enters the patient’s
eyes.
Fluorescent surgery
►Only use fluorescent agents that are approved for the planned appli-
cation.
►Danger of injury to the eyes due to possibly hazardous infrared and UV
light. Do not look at the Aesculap Aeos illumination, minimize expo-
sure to eyes or skin, and use appropriate shielding.
►Use the lowest comfortable light intensity.
►Ensure that no tissue damage is caused by excessive illumination
intensity.
►The room lighting impairs the visualization of fluorescence. For sur-
geries using the Aesculap Aeos fluorescence modules, operate in a
darkened room, if possible.
►Always perform a functional test before using the fluorescence mod-
ules, see Chapter 3.4.1. Use the reference cards to check whether the
fluorescence medium can be excited for the Aesculap Aeos wave-
length range and whether it emits fluorescent light of sufficient inten-
sity.
Note
As in almost all diagnostic procedures, false-positive and false-negative
results can occur in the fluorescence-based digital overlay. Evaluation by
the user based on other methods may be necessary.
Place of use
This system is not suitable for use in the presence of flammable anesthet-
ics mixture with air or with oxygen.
►Do not use system in explosive atmospheres.
►To prevent fire or shock hazard, do not expose system to rain or mois-
ture.
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Footswitch PV014
►Always carry and lift the footswitch using the carrying handle.
►Place footswitch on hanger at the base of the Aesculap Aeos when not
in use.
►Switch off Aesculap Aeos before cleaning or maintenance work on the
footswitch.
►Keep footswitch within a range of max. 10 m to the receiver.
►Do not place the footswitch in or near strong magnetic fields.
►Do not use more than four wireless systems in the same area.
The footswitch is regularly powered by three alkaline batteries of type C
“Baby” (IEC-LR 14; included in delivery), which are placed behind the
backside battery cover.
►If they need changing, the terminal must be switched off first in order
to rule out any unintended triggering of functionality.
►Only use footswitch with the specified batteries.
►To prevent the footswitch from battery leakage, remove battery from
the case during long periods of non-use.
►Never touch the battery contacts and the patient at the same time.
The maximum mechanical load which the operating elements may be
subjected to is max. 1350 N.
The integrated accelerometer prevents an accidental actuation of switch-
ing element if the inclination passes 35°.
►Only use footswitch on a firm, even (horizontal) surface.
►During use, do not tilt (> 35°) or move the footswitch because this can
lead to immediate cancellation of signals and functionality.
Ambient conditions
The following environmental conditions apply to the use of the product:
2.3.3 Sterility
Non-sterile packaged products
The product is supplied non-sterile and must be used under non-sterile
conditions.
►Inspect the new product after removing its transport packaging and
prior to first use to ensure it is in good working order.
Sterile products
The product is the only sterile component of the system.
►Place an Aesculap Aeos sterile drape prior to surgery.
►Do not use the product if it is damaged or defective.
►In case of intraoperative damage of the drape: remove the system
from the operating table and replace the drape.
The product has been EO-sterilized and is supplied in sterile packaging.
►Do not use products from open or damaged sterile packaging.
►Do not use the product after its use-by date.
►Do not reuse the product.
The reprocessing of the product affects its functionality. Risk of injury, ill-
ness or death due to soiling and/or impaired functionality of the product.
►Do not reprocess the product.
2.4 System set-up
Non-compliance with the following instructions will preclude all respon-
sibility and liability in this respect on the part of Aesculap.
►When setting up and operating the product, adhere to
– national regulations for installation and operation,
– national regulations on fire and explosion protection.
►Make certain that the control elements, mains power switch and
power socket are freely accessible for the user.
►Set up the product in such a way that it can be easily disconnected
from the mains.
►Lay non-system cables and cords separately. RF cables in particular
can cause strong interference.
►If interference from external devices is suspected, immediately deac-
tivate those devices, if possible, until the source of interference is
found. If necessary, consult a specialist in medical electrical devices to
remedy the interference.
►Make certain that the ventilation slots at the back of the housing are
not covered, e.g. by an OR cloth.
Note
For the safety of patients and users it is essential that the mains power
cord and, especially, the protective earth connection are intact. In many
cases defective or missing protective earth connections are not registered
immediately.
►Connect the device via the potential equalization pin jat the front of
the base to the potential equalization system of the room used for
medical purposes, see Fig.4.
Note
Installation and initial commissioning may only be performed by Aesculap
representatives.
Aesculap Aeos (Digital Surgical Microscope) PV010
Temperature 10 °C to 30 °C
Relative humidity 30 % to 90 %; non-condensing
Atmospheric pressure 700 hPa to 1 060 hPa
Aesculap Aeos foot switch wireless PV014
Temperature 10 °C to 40 °C
Relative humidity 30 % to 90 %; non-condensing
Atmospheric pressure 800 hPa to 1 060 hPa
Art. no. Designation
PV008 26” Full HD 3D Monitor
PV010 Aesculap Aeos (Digital Surgical Microscope)
PV011 Upgrade kit for the integration of a 3D monitor
PV014 Aesculap Aeos foot switch wireless
PV022 Software module DUV 400
PV023 Software module DIR 800
PV024 Software module DICOM
PV030 White balance card
Art. no. Designation
PV012SU Aesculap Aeos sterile drape
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2.4.1 3D display and robotic arm workspace
To help with positioning the Aesculap Aeos in the operating room, the
base dimensions, the minimum and maximum extensions of the 3D dis-
play arm, and the height and maximum extension of the robotic arm are
shown below.
Fig.6
Legend
aMax. length (arm fully extended)
bMax. monitor height
cMin. monitor height
dHighest point (roll through doors)
eRadius
fMinimum width to roll through doors
There are three recommended layouts for the operating room.
Note
For additional operating room layout examples, please contact your local
B.Braun/Aesculap representative
Neurosurgery operating room layout (example)
Fig.7
Legend
aSurgeon
bAssistant
cScrub nurse
Spinal surgery operating room layout (example)
Fig.8
Legend
aSurgeon
bAssistant
cScrub nurse
f = 668 mm
763 mm
a = 2,34 m
e = 1,24 m
390 mm
515 mm
350 mm
400 mm
425 mm
d = 1,86 m
c = 1,47 m
b = 2,03 m
a
b
c
a
b
c
45°
20 cm
<5 cm
80°
a
b
c
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Semi-sitting operating room layout
Fig.9
Legend
aSurgeon
bAssistant
cScrub nurse
2.4.2 Connecting the power supply
DANGER
Risk of fatal injury from electric shock!
►Connect this equipment only to a supply mains with protective
earth.
►Connect the main power cable directly to a power outlet. Do not use
un-approved extension cords or multiple socket-outlets. Use uninter-
ruptible power source when loss of power would result in an unac-
ceptable risk.
►Lay the power cable in areas with minimal foot traffic.
►Place power cable on hanger at the base of the Aesculap Aeos when
not in use.
2.5 Functional test
Before turning the Aesculap Aeos system on
►Check that the castors are locked once the base is in the desired loca-
tion. Make sure the base is stable and cannot roll in any direction.
►Connect the main power cable, see Chapter 2.4.2.
►Connect any external input or output video or Ethernet cables, see
Chapter 2.1.3.
►Check that there are no unnecessary objects or people within the
range of the robotic arm workspace.
►Check that the camera optical path is clean and free from dust.
►Ensure that exposed cables for the footswitch, any external displays,
and power supply are laid flat on the ground and out of high-traffic
areas to minimize potential tripping hazards.
After turning the system on and before starting the surgery
►Position the universal coupler as desired, see Chapter 3.2.1.
►Move the robotic arm from “Storage” to “Drape” position, see
Chapter 3.2.1.
►Follow the instructions printed on the drape packaging to correctly
apply the drape to the camera and robotic arm.
►Position Aesculap Aeos at the OR table.
►Position the 3D display for the surgeon’s viewing preference.
►Check that the “Zoom”, “Focus”, and “White Light Level” handle but-
tons are functioning properly.
►Check that the 3D image colors, focus, and alignment look correct.
►Check that the robotic arm assisted drive is moving smoothly and pre-
dictably.
►Check that the footswitch is paired with the system and the buttons
are working properly.
►If using fluorescence visualization (DIR 800 or DUV 400), check the
fluorescence module using a reference card to ensure proper working
order.
2.6 Application
2.6.1 Positioning the 3D display
►For ideal viewing, position the 3D display next to the patient table,
between 4 and 6 feet (1 to 2 meters) away from the surgeon.
►Position the screen perpendicular to and at the same height as the sur-
geon’s eyes when he or she is seated at the operating table.
The 3D display arm’s maximum extension and height are shown below:
Fig.10
Legend
aTop of the screen
bMax. monitor height (top of the screen)
cMin. monitor height (top of the screen)
a
b
c
c
80°
b
515 mm
350 mm
400 mm
a
b = 2,03 m
c = 1,47 m
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2.6.2 Turning the system on
►Perform the relevant items of the function checks, see Chapter 2.5.
Fig.11
Legend
aMain power button
►Press the main power button alocated on the front panel of the base,
next to the power cable connection and LED indicators.
The LED ring around the main power button lights up green.
The displays, camera, computers, robotic arm, and software are set to
automatically start when the system is turned on.
►Wait for the system to initialize (about 90 seconds).
The system will be ready for use once the Aesculap Aeos software has
opened and the notification “Aesculap Aeos initializing, please wait…”
is no longer displayed.
2.6.3 Enable footswitch
After every restart of the Aesculap Aeos software, the first time a but-
ton on a paired footswitch is pressed a message will appear on the
screen to confirm footswitch usage.
Fig.12
►Press “Confirm” button to confirm the usage of the footswitch.
►Press “Cancel” button if the footswitch is not needed and confirm the
second message with “Yes” button.
The footswitch is deactivated until the next start of the Aesculap Aeos
software.
2.6.4 Setting up the robotic arm and the camera
Rotating the Aesculap Aeos using the universal coupler
Depending on the surgical approach and operating room layout, it may be
advantageous to rotate the camera 90° to the left or right.
Note
For semi-sitting approaches it may be necessary to flip down the universal
coupler (camera NOT rotated).
►Only flip down the universal coupler before draping, using the proper
“Reconfigure Coupler” workflow. Do not flip down the universal cou-
pler during surgery.
CAUTION
When the coupler is set to the semi-sitting position, there are 3
known possible contact points.
►Use caution to avoid the following positions:
–When set to Semi Sitting Elbow Down, it is possible to contact
the elbow joint with the arm base of the cart. Observe patient
and avoid contact.
–When moving from positions Semi Sitting Left Elbow Up to
Semi Sitting Right Elbow Up, move to the drape position first
instead of moving directly from one position to the next. This
will prevent the camera from contacting the elbow to wrist
joint.
–When moving from positions Semi Sitting Right Elbow Up to
Semi Sitting Left Elbow Up, move to the drape position first
instead of moving directly from one position to the next. This
will prevent the camera from contacting the elbow to wrist
joint
Note
To flip down the universal coupler it is recommended to slightly lift the
camera to avoid potential sticking of the slider.
►Once the system has fully started up, go to the “Robot” tab in the
Aesculap Aeos home screen, see Fig.31.
►Under “Coupler”, press the “Reconfigure Coupler” button.
►Press and hold the “Hold or Reconfigure position” button until the arm
is fully extended.
Fig.13
Legend
aSliders to rotate camera
bSliders to flip down camera
►Unlock the sliders a/band rotate the Aesculap Aeos manually into the
desired position.
For available coupler positions, see Fig.14. The geometry limits of the
robotic arm will change based on the coupler position.
a
a
b
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Fig.14
►Press the “Hold for Drape position” button in the Aesculap Aeos soft-
ware until the movement is finished.
Moving the robotic arm out of storage position and draping the
robotic arm
The camera and distal portion of the robotic arm must be draped using
the provided Aesculap Aeos sterile drape PV012SU prior to surgery.
►Only use sterile drape PV012SU, as sterile covers from other manufac-
turers can impair system performance as well as image quality.
Note
Additionally, the base may be draped at the user’s discretion (base drape
not provided by Aesculap). For drape dimensions, see Chapter 2.1.9.
Fig.15
►Once the system has fully started up, move the robotic arm into the
“Drape” position, see Fig.15.
►Move the universal coupler into the position used during the proce-
dure.
Fig.16
►Remove drape from sterile packaging and unfold, see Fig.16.
Fig.17
►Notice the correct position of the drape lens, see Fig.17.
Fig.18
►Put the drape over the camera, align the lens using the locking pin and
attach the lens housing to the ocular ring using snap elements on the
side, see Fig.18.
Fig.19
►Pull the drape bag completely over the robot arm, see Fig.19.
Fig.20
►Attach the adhesive tape as follows, see Fig.20:
– Attach tape 1.
– Attach tape 2. Ensure that it fits loosely and that the cables are not
squeezed (force on sensor between camera and universal coupler).
– Attach tapes 3and 4.
-90° 0°
90° 90°
1
21
3
4
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Fig.21
►Remove the protective lens film, see Fig.21.
Note
It is recommended to rebalance the Aesculap Aeos after draping, see
Chapter 3.2.2.
►Perform all the remaining items of the function checks before starting
the surgery, see Chapter 2.5.
Note
If the universal coupler has to be rotated during the procedure, the adhe-
sive tapes must be loosened beforehand in order to avoid tension on the
sensor.
Tension on the sensor may cause the balancing process to fail.
2.6.5 Starting a case
Once the Aesculap Aeos arm has been draped and all pre-operative
checks are complete, a new case can be started.
Fig.22
►Select a surgeon profile and a patient in the “Case” tab.
– or –
►Add a new Surgeon profile or Patient by using the Add button.
Aesculap Aeos settings and preferences are saved for each Surgeon
profile.
The Delete button is disabled when the “Default Surgeon” or
“Default Patient” is selected, but it can be used to delete custom pro-
files.
►When the DICOM settings are configured to a networked database,
select the “DICOM” toggle and search for a patient. To search all listed
patients in the database, enter an asterisk (*) in the first and last name
search fields.
►Once the desired surgeon and patient have been chosen, press “Start
Case” to advance to the live screen, see Chapter 3.3.
2.6.6 Taking videos and snapshots of live view
Snapshots and videos of the current live image can be taken with the two
buttons in the upper left corner.
2.6.7 Ending a case
►Select the End Case button to end the current case.
If settings have been changed during the case, a message window will
appear with options to discard changes, overwrite current profile or
create a new surgeon profile.
Fig.23
►Press the corresponding option and confirm selection.
If recordings or snapshots were taken during the case, there will be
options to save and/or upload the case media for both DICOM and
non-DICOM patients to the DICOM server (if applicable), local drives,
or connected external drives.
2.6.8 Saving case media
If snapshots and/or images were recorded, ending the current case will
prompt users to save the media. The patient information can also be
updated at this time, even if the case was started with previously saved
information.
Save to default location
After selecting to end the case:
Fig.24
►Press “Yes” to continue saving the media information.
– or –
►Press “No” to permanently delete all case media (this will require con-
firmation).
– or –
►Press “Cancel” to return to the case.
Selecting “Yes” will allow the patient’s information to be added or
updated. Patient information saved prior to starting the case will be
retained at the end of the case.
Button Description
Start/stop video recording of current live view.
Take image snapshot of current live view.
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Fig.25
►Enter a first and last name, then press Next button to continue, or
Cancel button to return to the “Save Recorded Media?” message.
►Press the pencil button to add or update “Optional Patient Data”.
This option is enabled once a first and last name have been entered.
►Press OK button when done editing to proceed.
Fig.26
From the “Media Information” screen, optionally keyword(s) can be
entered or the folder name changed.
►Press Back button to return to the previous screen or press OK
button to proceed.
Copy media to drive
Fig.27
►To copy case media to an available local or externally connected drive,
select the drive letter from the drop-down list, then press “Yes”
– or –
►Press “No” to save to the default location only.
The save media screens will close and the application returns to the
home screen.
There will be progress messages for the copy in progress, as well as
confirmation once it completes.
Note
The location where case media will be saved is F:\TVS\TrueVision\Sur-
geons\<SurgeonName>. Selecting an additional drive to copy to will be in
addition to the default location.
2.6.9 Removing the drape
At the end of the case or when the robotic arm drape needs to be
removed:
►Ensure the area is clear of objects or people and move the robotic arm
into the “Drape” position, see Chapter 3.2.1.
►Release the adhesive tape on the drape bag.
►Remove the lens housing of the sterile cover from the camera using
the buttons on the side.
►Invert and remove the drape along the robotic arm.
►Dispose the sterile drape in compliance with medical waste regula-
tions.
2.6.10 Shutdown procedure
For safety, it is important to follow proper shutdown procedure when the
Aesculap Aeos system is not in use.
►After the drape has been removed from the robotic arm, press the Exit
button.
►Once the 3D display is cleared from the robotic arm movement path,
move the robotic arm to “Storage” position, see Chapter 3.2.1 or press
“Cancel” button (return to the application).
Once the robotic arm is fully in “Storage” position, the software will
automatically provide further options to “Shut Down”, or press “Can-
cel” button (return to the application).
Fig.28
►Press “Shut Down” button.
The system shut down sequence starts.
After the EPU shuts down, the LED at the front panel (Camera, Robot,
EPU) and also the system fans will turn off.
Fig.29
Legend
aMain power button
►Once the system is shut down turn off the system power with the main
power button a.
2.6.11 Putting out of operation
Note
The safe and all-pole disconnection of the Aesculap Aeos system from the
supply mains is only guaranteed when the power supply cord is unplugged.
►Shut down the Aesculap Aeos system, see Chapter 2.6.10.
►Unplug the power supply cord from the supply mains.
a
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2.6.12 Changing footswitch batteries
►Shut down Aesculap Aeos, see Chapter 2.6.10.
►Open battery housing: Rotate both lockers near battery housing by
90°. While doing so, lightly press down the battery cover.
►Lift the empty batteries by the ejector belt and remove them.
►Insert new batteries. Keep attention to the right polarity (see marking
on battery compartment bottom).
►Only use alkaline batteries. The use of rechargeable batteries is not
allowed.
►Never mix used and new batteries.
►Close battery housing: rotate both lockers back to original position.
►To protect the footswitch from battery leakage during long periods of
non-use, remove the batteries from the battery compartment.
3. Software
3.1 Home screen
The Aesculap Aeos software starts on the home screen on the control
screen.
Fig.30
Symbols
3.2 Setup
The “Setup” panel in the home screen provides the following functions:
■Move the robotic arm to a preset position
■Rebalance the Aesculap Aeos
■Enter recovery state
■Reconfigure the coupler.
Fig.31
3.2.1 Preset positions
The available preset positions are:
■Drape
■Drape Standby
■Semi-Sitting Left (Elbow Down)
■Semi-Sitting Left (Elbow Up)
■Semi-Sitting Right (Elbow Down)
■Semi-Sitting Right (Elbow Up)
■Storage
Note
Semi-Sitting presets are only available in Semi-Sitting coupler configura-
tion.
Soft stop
As a risk control, the software has a soft stop button in the
unlikely scenario that the robotic arm moves in an unpredict-
able way. The soft stop button halts all robotic arm movement
when pressed. The button is available in both the home and
live screens.
The button will change color from red to gray when engaged.
Press the button again to remove the soft stop and allow the
robotic arm to move again. The button will change back to red.
Eject drive
When an external USB drive is connected to the system, select
the Eject button to properly eject the drive. The software will
confirm the drive has been ejected and can be physically
removed.
Media Upload Queue
Here the queued DICOM uploads can be seen and the upload
process can be started.
Software settings
see Chapter 3.6
TrueMedia application
Select the TrueMedia application playback button to view or
edit surgical content. The Aesculap Aeos software will need to
close in order to open TrueMedia.
Fullscreen view
Select the fullscreen button to enter fullscreen mode, which
displays the surgery view and contains active status messages
and the buttons for emergency stop, settings, and exit
fullscreen mode. The fullscreen view button is available in both
the home and live screens.
Select the close fullscreen button to exit fullscreen mode.
System shutdown
see Chapter 2.6.10
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Fig.32
Legend
aKeep this area clear vertically during position change
bKeep this area clear horizontally during position change
WARNING
Risk of injury due to unintended movement of the robotic arm!
►Make sure the area surrounding the robotic arm is clear of objects
or people.
►Watch the robotic arm while it is moving.
►Select a pre-configured position for the robotic arm in the “Position”
drop-down list.
►Press the “Press and Hold to auto-position” button until the robotic
arm movement fully stops in position.
3.2.2 Rebalance scope
Moving the robotic arm to its limits can affect the Aesculap Aeos’ bal-
ance. To correct the presence of any drift, the Aesculap Aeos can be rebal-
anced.
The Aesculap Aeos robotic arm is factory-calibrated. It is recommended to
rebalance the robotic arm once annually or as needed, especially if the
robotic arm feels unbalanced during movement with the handle brake-
release buttons.
►Ensure the area of the robotic arm is clear.
►Press “Rebalance Scope” in the “Setup” tab.
In rare instances, some configurations can cause the robotic arm to lock
up when reaching the joint limits.
►If this occurs, move the robotic arm to a preset position.
Note
If proper rebalancing of the Aesculap Aeos still results in unsatisfactory
balance, contact Aesculap Technical Service for assistance, see
Chapter 7.2
3.2.3 Robot Recovery
CAUTION
Robot Recovery can damage the system or its cables by moving the
robot outside its defined limits.
►Only use Robot Recovery in emergencies.
►First try the following steps before using Robot Recovery:
–Position the robot via handle / foot switch.
–Position the robot via preset positions (e.g. Drape Position,
Standy Positon, see Fig.31) on the touch screen.
Fig.33
►Press and hold the white arrow buttons to move the robot.
►Avoid collisions of the robot or jamming of the cables.
3.3 Live screen
Selecting “Start Case” in the “Case” tab advances to the live screen,
intended for live surgery. The Live Screen shows controls for the camera,
robotic arm, recording, fluorescence, and access to settings.
Fig.34
Legend
1Settings bar
2Control panel
3Live image
4Quick Access Bar (QAB)
b = 1 240 mm
a = 450 mm
1
2
3
4
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3.4 Control panel
Fig.35
Legend
1“Camera” tab
2“Robot” tab
3“Setup” tab
4“Waypoints” tab
3.4.1 Camera
The “Camera” tab within the control panel shows controls for zoom,
focus, white light levels, and fluorescence light levels (if licensed). The
control values can be adjusted by using the handles, footswitch, or the
control screen.
►Press anywhere on the value bar or press and drag the slider to change
the values.
►Select the or buttons for fine tuning.
Fluorescence controls
Note
Fluorescence modules (DUV 400 and DIR 800) require a license for use with
the Aesculap Aeos system.
DUV 400: The integrated DUV 400 fluorescence module of the
Aesculap Aeos is used to visualize near-UV fluorescent areas in the surgi-
cal field. The module has been designed for excitation in the wavelength
range from 390 nm to 420 nm and for fluorescence visualization in the
wavelength range greater than 510 nm. The module enables the surgeon
to switch between white light and blue-violet excitation light for fluores-
cence. In addition to visualization, users can record fluorescent and auto-
fluorescent light emitted by tissue by enabling the “Overlay” feature.
DIR 800: The integrated DIR 800 fluorescence module of the
Aesculap Aeos is used to visualize infrared fluorescent areas in the surgi-
cal field and includes features to record and play back a video clip of the
area of focus where fluorescent light is emitted. The module has been
designed for excitation in the wavelength range from 740 nm to 800 nm
and for fluorescence visualization in the wavelength range from 820 nm
to 900 nm. The fluorescence feature generates an image in the infrared
spectrum, which means it cannot be seen by the naked eye.
Fluorescence controls can be adjusted by using the handles, footswitch,
or control screen.
Note
The “Autofocus” feature is disabled while fluorescence functions DUV 400
or DIR 800 are enabled. Use the control screen, handles, or footswitch to
manually refocus the target image.
Function checks
WARNING
The fluorescence reference card and the control screen are not ster-
ile!
►Perform fluorescence functional tests before surgery.
►Before starting fluorescence visualization, always check the function-
ality of the integrated fluorescence module.
►Ensure that the Aesculap Aeos system is in a dark room, with no other
illumination other than the Aesculap Aeos integrated lighting and the
system displays.
►Place the reference card on a level surface.
►Set the focus to 325 mm and the zoom to 5 × on the control screen.
►Refocus the image by moving the camera upwards or downwards
using assisted drive.
►Activate the fluorescence function by selecting the “DUV 400 On” or
“DIR 800 On” button on the control screen or the corresponding han-
dle or footswitch button.
►In the live image, check the following:
–DUV 400: There is distinct contrast (orange/pink) between the
DUV 400 reactive compound and the reference card (green/white).
–DIR 800: There is distinct contrast (black/white) between the DIR
800 reactive compound and the reference card.
– The reactive compound must be clearly distinguishable and the live
image should not be washed out. Slight deviations in color and
brightness are acceptable.
DUV 400 imaging
The following factors influence the visualization of the fluorescence sig-
nal:
■Fluorescence medium and its concentration in the tissue
■Transmission of the optical system
■Working distance and the illuminated field diameter
■Selected white light level
■Selected fluorescence light level
►Ensure that no navigation systems are directed at the surgical field
during the DUV 400 application and turn off the ambient lights or any
lamp that can illuminate the field of view.
►Activate the fluorescence function by selecting the “DUV 400 On” but-
ton on the control screen or the corresponding handle or footswitch
button.
The white light level can be increased to allow for better visualization
of the surrounding area.
The “Aesculap Aeos Control” panel will still be available and – addi-
tionally – the “Fluorescence Light Level” value bar can be adjusted
while DUV 400 is on (default value: 100 %).
►Select “Overlay” to show an overlay of captured fluorescence in the
live view.
►Select “FL Off” to turn off near-ultraviolet light and return to white
light only.
Setting Range
Zoom 1.00 × to 10.00 ×
Focus 200 mm to 450 mm
White Light 0 % to 100 %
Fluorescence
Light (DUV)
0 % to 100 %
Fluorescence
Light (DIR)
75 % to 100 %
1
2
3
4
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Aesculap, Inc. - Document No.: TA015615 - Version: 6.0 - Document ID: SOP-AIC-5001887 - Effective Date: 2022-10-06 - Status: Effective

USA
DIR 800 imaging
Optimum illumination in DIR 800 fluorescence module is achieved if the
illuminated field of focus diameter on the Aesculap Aeos is set to the
middle position of the live image, i.e. a small depth of field is set, as well
as the smallest acceptable working distance.
The following factors influence the visualization of the fluorescence sig-
nal:
■Fluorescence medium and its concentration in the tissue
■Transmission of the optical system
■Working distance and the illuminated field diameter
■Selected white light level
■Selected fluorescence light level
■Working distance
CAUTION
The light output of the LED decreases as they heat up (for example,
with increased operating time of the light source) and, as a result, the
brightness of fluorescence decreases.
►When using DIR 800, do not exceed a working distance of 300 mm
as indicated by the Focus slider.
►Ensure that no navigation systems are directed at the surgical field
during the DIR 800 application and turn off the ambient lights or any
lamp that can illuminate the field of view.
►Activate the fluorescence function by selecting the “DIR 800 On” but-
ton on the control screen or the corresponding handle or footswitch
button.
The “Aesculap Aeos Control” panel will still be available and – addi-
tionally – the “Fluorescence Light Level” value bar can be adjusted
between 75 % and 100 % while DIR 800 is on (default value: 100 %).
The software will begin a recording with a 01:40.00 (MM:SS.MS)
countdown timer that will continue until either the “Playback” or “FL
Off” button is selected or the timer reaches 00:00.00. If the timer is
allowed to reach 00:00.00, DIR 800 will automatically advance to
“Playback” mode.
The white light level can be increased to allow for better visualization
of the surrounding area.
Once in “Playback” mode, the captured DIR 800 recording will loop
playback in “Picture in Picture (PiP)” view, until “FL Off” is selected.
►Take multiple DIR 800 recordings by selecting “DIR 800 On” again.
Selecting “Playback” will continue to loop through all recordings,
starting with the most recent. All DIR 800 recordings taken within a
case will be available for playback during the case and will be saved
as separate recordings, if select to do so when ending the case.
►Navigate through DIR 800 recordings using the dedicated buttons in
the “PiP” view on the control screen or by using configured control
buttons on the handles or footswitch.
►Select “FL Off” to stop playback and return to white light only.
Changing DIR 800 recording quality
Fig.36
►Select the Settings button to open system settings panels.
►Select the Recording button.
►In the “Recording” panel, press the “Advanced” tab.
The recording quality can be adjusted using the “DIR 800 Quality”
slider.
The recording quality and the corresponding file size can be increased
from left to right.
►Save changes and close panel using the OK button.
3.4.2 Robot
“Control” tab
Fig.37
The robotic arm pan and rotation movements can be controlled from the
“Robot” tab in the control panel in precise, single-axis movements. Each
arrow (Forward, Back, Left, Right, Up, and Down) corresponds to a direc-
tional movement in relation to the camera.
Holding down one of the directional arrow buttons moves the robotic arm
until a joint limit is reached. Directional movements can also be employed
by configuring the corresponding commands to the handle buttons (see
Chapter 3.6.10) or footswitch buttons (see Chapter 3.6.11).
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Aesculap, Inc. - Document No.: TA015615 - Version: 6.0 - Document ID: SOP-AIC-5001887 - Effective Date: 2022-10-06 - Status: Effective