Connection point for potential equalization conductor
devices according to directive
2002/96/EC (WEEE), see Chapter 12.
1.General information
1.1Symbols on product and packaging
SymbolLocationDescription
Base of cartMain power switch.
Press to turn the system ON.
Press again to turn the system OFF
Product labelAC input
DSM headDC input
Product labelWarning
Product labelRisk of electric shock! Do not open.
Robotic armTake care to avoid injury when in the
vicinity of the display arm or robotic
arm.
Support armsDo not exceed load ratings for support
arms.
Product labelFollow instructions for use.
Product labelRevision
1.2Applicable to
These instructions for use are applicable to the following products:
Art. no.Designation
PV010Aesculap DSM (Digital Surgical Microscope)
PV022Software module DUV 400
PV024Software module DICOM
PV030White balance card
1.3Warnings
Warnings make clear the dangers to patient, user and/or product that
could arise during the use of the product. Warnings are labeled as follows:
Danger of death or serious injury.
DANGER
Danger of minor injury or product damage.
WARNING
Cart emergency stop
Product labelSystem mass
Product labelManufacturer
Emergency stop control device
Indicates a possible threat of material damage. If
not avoided, the product may be damaged.
CAUTION
1.4Intended use
This device is for use with patients undergoing microsurgery within its
indications for use.
There is no patient contact intended with this device.
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1.5Indications for Use
Aesculap DSM (Digital Surgical Microscope) PV010
The Aesculap DSM (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® DSM 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
1.6Contraindications
The DSM system must not be used for ophthalmology.
2.Safe handling
CAUTION
Federal law restricts this device to purchase by, or on instruction by a
physician!
Risk of fatal injury from electric shock!
► Do not open the product.
DANGER
► Manually clean the new product after removing its transport packaging
and prior to first use.
► Prior to use, check that the product is in good working order.
► Observe “Notes on Electromagnetic Compatibility (EMC)“, see
TA015615-EMV.
► 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.
► Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
► Keep the instructions for use accessible for the user.
► 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, head, any external dis-
plays, and power supply are laid flat on the ground and out of hightraffic 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 DSM head
and arm.
► Ensure the E-stop is not locked prior to surgery.
► Use the protective stop on the touchscreen if there is unintended robot
arm movement.
► Use the E-Stop only if the protective stop malfunctions.
► Check fluorescence functionality prior to surgery using the provided
reference card.
► Ensure that the DSM head working distance is between 20 cm and
45 cm.
► The fluorescence reference card and the touchscreen are not sterile.
Perform fluorescence functional tests before surgery.
► Take precautions to avoid touching any system components and the
patient at the same time.
► Connect the product only to a grounded power
supply.
► Do not push or pull the product by the display, head, or power cable.
► To ensure optimal image quality, only use product with 3D glasses sup-
plied 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 head with the lens cap covering the main objective when it
is not in use.
► Do not cover the air vents of the system, touchscreen, or 3D display.
Note
When the emergency stop is pressed, the DSM head may move up to 3 cm
(depending on position) due to mechanical brakes locking into place.
This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instruction manual, may
cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in
which case the user will be required to correct the interference at his or
her own expense. You are cautioned that any changes or modifications not
expressly approved in this manual could void your authority to operate this
equipment.
All interface cables used to connect peripherals must be shielded in order
to comply with the limits for a digital device pursuant to Subpart B of Part
15 of FCC Rules. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
■ Mode of operation: Continuous
■ Protection against electric shock: Class I
2.1Light 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 DSM enters the patient’s eyes.
2.2Fluorescent surgery
► Only use fluorescent agents that are approved for the planned applica-
tion.
► Danger of injury to the eyes due to possibly hazardous UV light. Do not
look at the DSM illumination, minimize exposure to eyes or skin, and
use appropriate shielding.
► Use the lowest comfortable light intensity.
► Ensure that no tissue damage is caused by excessive illumination inten-
sity.
► The room lighting impairs the visualization of fluorescence. For surger-
ies using the DSM fluorescence modules, operate in a darkened room,
if possible.
► Always perform a functional test before using the fluorescence mod-
ules, see Chapter 6.4.1. Use the reference cards to check whether the
fluorescence medium can be excited for the DSM wavelength range
and whether it emits fluorescent light of sufficient intensity.
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.
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2.3Place of use
This system is not suitable for use in the presence of flammable anesthetics 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.
2.4Ambient conditions
The following ambient conditions apply to the use of the product:
Temperature
Relative humidity
Atmospheric pressure
10 °C to 35 °C
30 % to 90 %; non-condensing
700hPa to 1060hPa
2.5DSM sterile drape PV012SU
Infection hazard for patients and/or users and
impairment of product functionality due to reuse.
WARNING
The product has been EO-sterilized and is supplied in sterile packaging.
The product must not be reused.
The product is the only sterile component of the system.
► Place a drape prior to surgery.
► Do not use products from open or damaged sterile packaging.
► 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.
► Do not use the product after its use-by date.
Risk of injury, illness or death due to contamination
and/or impaired functionality of the product!
► Do not reprocess the product.
Note
Wireless mode is not possible when the foot switch is connected via USB
cable.
3.Product description
The Aesculap DSM is a freestanding, digital surgical microscope in a lookover configuration. The DSM does not utilize traditional microscope binoculars within the field of use and is intended to be an alternative to traditional optical microscopes. The DSM software is a component of the
medical device.
The main components of the DSM system are:
■ 3D flat panel display 1 – live surgical view
■ Touchscreen 2 – control interface
■ Robotic arm 3
■ DSM head 4 – 3D camera, illumination, and handle controls
■ Medical-grade cart 5 with embedded computers
■ Footswitch 6
■ Visualization software
■ Sterile drape
3.1Robotic arm
The robotic arm is a six-jointed arm that supports the DSM head. Its
touch-guided movement allows the user to manipulate it through the
workspace. The robotic arm may be controlled via the handles, footswitch,
or touchscreen. On the 3D display, the robot state indicator shows the current state of the robotic arm. The robotic arm workspace is illustrated
below.
2.6Footswitch PV014
► 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), 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 or backup cable.
► 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 switching element if the inclination passes 35°.
► Only use footswitch on a firm, even (horizontal) surface.
When using the backup cable:
► When connecting the backup cable, always ensure that connecting ele-
ments (plugs) are clean.
► Ensure that the plug connections are not subjected to mechanical
loads.
► Do not subject backup cable to excessive pulling, pressure or bending.
Do not drive over cable.
► Always perform function test in combination with the DSM when the
device is switched back on.
390 mm
425 mm
a = 1,24 m
Fig.1
Legend
aMax. radius
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3.2DSM head
The DSM head contains two sets of optics and two high-resolution sensors
to convert the analog signal to a digital video stream.
b = 200 mm
c = 450 mm
Fig.2
Legend
aBottom of DSM head
b Min. working distance
cMax. working distance
3.2.1LED indicator
The DSM head has an LED indicator on the back panel. The indicator colors
are explained below.
IndicatorDescription
3.2.2Handle buttons (default setting)
The DSM is designed to be controlled primarily through the buttons on the
handles of the sides of the head. The default layout of the handles is shown
below. In the software Handles settings, the handle button commands can
be customized.
a
b
c
d
a
e
f
g
h
i
lml
j
n
k
L
Fig.4
Legend
a
Assisted drive
b
Zoom +
c
White light +
d
Focus -
e
Auto focus
f
White light -
g
Zoom -
h
Assisted drive
i
Record
j
Focus +
k
Snapshot
l
Move up
m
Move left
n
Move down
o
Assisted drive
p
Move forward
q
Way point save/delete
r
Move right
s
Lock-on mode
t
Waypoint select/move
u
Move backward
v
Assisted drive
o
p
q
r
s
t
u
v
R
Blinking blueThe DSM head is starting up
Solid greenThe DSM head is ready for use
Solid yellowA 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
Fig.3
3.3DSM cart
The images acquired by the DSM head are delivered to the system computer (EPU) in the cart. This is a special-purpose computer, optimized to
process the images for storage, manipulation, and stereoscopic display.
The signals generated for display employ the Digital Video Interface (DVI),
delivering high resolution and high refresh rate stereoscopic display
images to the display devices. The DVI signals can be delivered to display
devices with DVI or HDMI cable connections.
The system computer is also fitted with a 2 TB storage drive or larger that
stores at least 100 hours of 3D HD videos. The videos can be immediately
accessed for playback due to real-time compression of the video stream as
it is recorded. The compressed video files can easily be transferred to external storage for backup and archival and to free space on the internal storage drive.
The cart also holds a second computer controlling the robotic arm.
3.3.1Emergency stop
The robotic arm emergency stop is located at the top of the cart. 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 Protective Stop button on the touchscreen.
► If the touchscreen 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 DSM head may move up to 3 cm
(depending on position) due to mechanical brakes locking into place.
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