Aesculap®

Aesculap Power Systems

USA Instructions for use/Technical description

DSM (Digital Surgical Microscope)
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Aesculap®
DSM (Digital Surgical Microscope)
Note 5.1 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CAUTION: RX only! 5.2 System set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.2.1 3D display and robotic arm workspace . . . . . . . . . . . . . . . . . . . 9
Legend 5.2.2 Connecting the accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.2.3 Connecting the power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1 3D flat panel display
5.3 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 Touchscreen
5.4 Positioning the 3D display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3 Robotic arm
5.5 Turning the system on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 DSM head
5.6 Setting up the robotic arm and the DSM head . . . . . . . . . . . . 11
5 Medical grade cart
5.6.1 Rotating the DSM using the yaw coupler. . . . . . . . . . . . . . . . . 11
6 Footswitch
5.6.2 Moving the robotic arm out of storage position and draping the
robotic arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
The illustrations in these instructions for use (especially illustrations of the
5.7 Starting a case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
software) may deviate from the actual device.
5.8 Ending a case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.9 Saving case media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Contents 5.9.1 Save to default location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5.9.2 Copy media to drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.1 Symbols on product and packaging . . . . . . . . . . . . . . . . . . . . . . 3 5.10 Removing the drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.2 Applicable to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5.11 Shutdown procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5.11.1 Software shutdown and robotic arm storage. . . . . . . . . . . . . . 13
1.4 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5.12 Changing footswitch batteries . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.5 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6. Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.6 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6.1 Home screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6.2 DSM setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1 Light emission risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6.2.1 Preset positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2 Fluorescent surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6.2.2 Rebalance scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.3 Place of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.2.3 Robot recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.4 Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.3 Live screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.5 DSM sterile drape PV012SU . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.3.1 Zoom, focus, and light controls . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.6 Footswitch PV014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.4 Fluorescence controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.4.1 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1 Robotic arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6.4.2 DUV 400 imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2 DSM head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6.5 Touchscreen robot control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2.1 LED indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6.5.1 Lock On Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2.2 Handle buttons (default setting) . . . . . . . . . . . . . . . . . . . . . . . . 6 6.5.2 Robot Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3 DSM cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6.6 Quick Access Bar (QAB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3.1 Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6.7 Robotic arm state indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3.2 Cart LED indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6.8 Software settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3.3 Cart connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6.8.1 Camera settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.4 3D display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6.8.2 Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5 3D display stand (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6.8.3 Digital Aperture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.6 Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.4 DUV 400 (Fluorescence) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.7 Footswitch PV014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.5 Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.7.1 Default footswitch button functionality . . . . . . . . . . . . . . . . . . 8 6.8.6 Recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.7.2 Footswitch status LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.7 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.7.3 Backup USB cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.8 Input Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.8 Isolation transformer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.9 DICOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.9 Wireless keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.10 Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.10 Polarized 3D glasses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6.8.11 Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.11 Additional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6.8.12 About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4. Preparation and setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 7. Reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5. Working with the product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 7.1 Single-use products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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7.2 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Symbol Location Description
7.3 Limitations on reuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7.4 Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Product label Date of manufacture
7.4.1 Product-specific safety instructions for the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Product label CSA NRTL Mark
7.5 Wipe disinfection for electrical devices . . . . . . . . . . . . . . . . . . . 21
7.6 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 21
7.7 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Product label CE marking acc. to DIR 93/42/EEC
7.8 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Touchscreen USB 3.0 port
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 mount label
9.1 Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Coupler label Yaw adjustment slider
9.2 Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
9.2.1 Startup errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
9.2.2 License error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Cart potential Connection point for potential equal-
9.2.3 Recording errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 equalization ization conductor
9.2.4 DSM head errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 conductor
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Product label Marking of electric and electronic
11. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 devices according to directive
11.1 Performance data, information about standards . . . . . . . . . . . 23 2002/96/EC (WEEE), see Chapter 12.
11.2 Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Product label Catalog number
12. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
13. Distributor in the US/Contact in Canada for product Product label Serial number
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Product label Revision

1. General information
1.1 Symbols on product and packaging 1.2 Applicable to
These instructions for use are applicable to the following products:
Symbol Location Description

Base of cart Main power switch. Art. no. Designation

Press to turn the system ON.
PV010 Aesculap DSM (Digital Surgical Microscope)
Press again to turn the system OFF
PV022 Software module DUV 400
Product label AC input
PV024 Software module DICOM
DSM head DC input
PV030 White balance card
Product label Warning
1.3 Warnings
Product label Risk of electric shock! Do not open. 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:

Robotic arm Take care to avoid injury when in the Danger of death or serious injury.
vicinity of the display arm or robotic
arm. DANGER
Support arms Do not exceed load ratings for support
arms. Danger of minor injury or product damage.

Product label Follow instructions for use. WARNING

Indicates a possible threat of material damage. If

Cart emer- Emergency stop control device
not avoided, the product may be damaged.
gency stop
CAUTION
Product label System mass
1.4 Intended use
This device is for use with patients undergoing microsurgery within its
Product label Manufacturer
indications for use.
There is no patient contact intended with this device.

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1.5 Indications 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 view-
ing 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
1.6 Contraindications
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 ► Connect the product only to a grounded power
supply.
► 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 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 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.
4
► 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 interfer-
ence 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. Oper-
ation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interfer-
ence received, including interference that may cause undesired operation.
■ Mode of operation: Continuous
■ Protection against electric shock: Class I
2.1 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 DSM enters the patient’s eyes.
2.2 Fluorescent 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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2.3 Place of use Note
This system is not suitable for use in the presence of flammable anesthet- Wireless mode is not possible when the foot switch is connected via USB
ics mixture with air or with oxygen. cable.
► Do not use system in explosive atmospheres.
► To prevent fire or shock hazard, do not expose system to rain or mois- 3. Product description
ture.
The Aesculap DSM is a freestanding, digital surgical microscope in a look-
2.4 Ambient conditions over configuration. The DSM does not utilize traditional microscope bin-
oculars within the field of use and is intended to be an alternative to tra-
The following ambient conditions apply to the use of the product:
ditional optical microscopes. The DSM software is a component of the
Temperature 10 °C to 35 °C medical device.
The main components of the DSM system are:
Relative humidity 30 % to 90 %; non-condensing
■ 3D flat panel display 1 – live surgical view
Atmospheric pressure 700 hPa to 1 060 hPa ■ Touchscreen 2 – control interface
■ Robotic arm 3
2.5 DSM sterile drape PV012SU ■ DSM head 4 – 3D camera, illumination, and handle controls
Infection hazard for patients and/or users and
■ Medical-grade cart 5 with embedded computers
impairment of product functionality due to reuse. ■ Footswitch 6
WARNING Risk of injury, illness or death due to contamination ■ Visualization software
and/or impaired functionality of the product! ■ Sterile drape
► Do not reprocess the product.
3.1 Robotic arm
The product has been EO-sterilized and is supplied in sterile packaging. The robotic arm is a six-jointed arm that supports the DSM head. Its
The product must not be reused. touch-guided movement allows the user to manipulate it through the
The product is the only sterile component of the system. workspace. The robotic arm may be controlled via the handles, footswitch,
► Place a drape prior to surgery. or touchscreen. On the 3D display, the robot state indicator shows the cur-
rent state of the robotic arm. The robotic arm workspace is illustrated
► Do not use products from open or damaged sterile packaging.
below.
► 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.

2.6 Footswitch PV014

► Keep footswitch within a range of max. 10 m to the receiver.
► Do not place the footswitch in or near strong magnetic fields.
390 mm
► Do not use more than four wireless systems in the same area. m m
4 25
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. 4m
1,2
The maximum mechanical load which the operating elements may be sub- a=
jected 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.

When using the backup cable:

► When connecting the backup cable, always ensure that connecting ele- Fig. 1
ments (plugs) are clean. Legend
► Ensure that the plug connections are not subjected to mechanical a Max. radius
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.

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3.2 DSM head 3.2.2 Handle buttons (default setting)
The DSM head contains two sets of optics and two high-resolution sensors The DSM is designed to be controlled primarily through the buttons on the
to convert the analog signal to a digital video stream. 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 o

b p
c i l q
d r
a j m
e s
f k n t
b = 200 mm g u

c = 450 mm h v
L R

Fig. 4

Legend
Fig. 2
a Assisted drive l Move up
Legend b Zoom + m Move left
a Bottom of DSM head c White light + n Move down
b Min. working distance d Focus - o Assisted drive
c Max. working distance e Auto focus p Move forward
f White light - q Way point save/delete
3.2.1 LED indicator g Zoom - r Move right
The DSM head has an LED indicator on the back panel. The indicator colors h Assisted drive s Lock-on mode
are explained below. i Record t Waypoint select/move
j Focus + u Move backward
Indicator Description k Snapshot v Assisted drive

Blinking blue The DSM head is starting up

3.3 DSM cart
Solid green The DSM head is ready for use The images acquired by the DSM head are delivered to the system com-
puter (EPU) in the cart. This is a special-purpose computer, optimized to
Solid yellow A minor error has occurred. See software mes-
process the images for storage, manipulation, and stereoscopic display.
sage for details.
The signals generated for display employ the Digital Video Interface (DVI),
Solid red A major error has occurred. User should switch delivering high resolution and high refresh rate stereoscopic display
to a backup system immediately 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 exter-
nal storage for backup and archival and to free space on the internal stor-
age drive.
The cart also holds a second computer controlling the robotic arm.

3.3.1 Emergency 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 touch-
screen.
► If the touchscreen does not respond, use the emergency stop to remove
power from the arm and cease all movement.
Fig. 3 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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3.3.2 Cart LED indicators ► Connect the display to the HDMI output port c at the back of the cart,
There are three LED indicators near the base of the cart that display the see Fig. 5.
status of the DSM, system computer (EPU), and robotic arm components. ► Configure the additional displays in the DSM software “Display” set-
The indicator colors are explained below. tings panel, see Chapter 6.8.7.
The individual display settings are specially configured at the factory.
Indicator Description When the PV644 or PV015 display is used in a high-temperature environ-
Solid green The component is ready for use. ment, the brightness of the display backlight is reduced to lower the tem-
perature inside the unit. When this function is activated, the power indi-
Solid yellow A minor error has occurred. cator flashes in amber. It is not recommended to drape the displays.
Solid red Warning – the component is not ready for use. Connecting a video stream from another device (input)
Video streams from other devices may be connected to facilitate display in
3.3.3 Cart connections conjunction with the 3D image from the DSM head.
The following devices are approved for providing video input:

Art. no. Designation

PV460 Full HD 3 chip camera control unit

PV470 Full HD CMOS camera control unit
PV480 2D camera platform
a
► Connect the device to the HDMI input port g or SDI input port h at the
front of the cart, see Fig. 5.
► Configure the video input in the DSM software “Input Source” settings
panel, see Chapter 6.8.8.
Connecting to a potential equalization system
Directly above the main power cord connection i, the DSM system is
equipped with a 6 mm potential equalization port j that can be connected
to the healthcare facility potential equalization system.
► Connect the display to the potential equalization port j at the front of
the cart, see Fig. 5.
Connecting to a PACS/RIS server
b c d e f g h i j There are two Ethernet ports on the both the front and back panels of the
cart.
Fig. 5
► Ensure that the Ethernet cable and connector comply with at least Cat-
On the touchscreen arm, there are the following connections: 5e EIA/TIA-568A-5, preferably Class D values from ISO/IEC 11801:2002
■ 2 × USB 3.0 ports a or EN 50173-I:2002.
At the back of the cart, there are the following connections: ► Connect an Ethernet cable to one of the Ethernet ports b or e to link
■ 2 × Ethernet ports b the system with the facility PACS server, see Fig. 5.
■ 2 × HDMI output ports c ► Configure the connection in the software DICOM settings. See
TA015615-DCS for the complete DICOM Conformance Statement.
■ 2 × USB 2.0 ports d
At the front of the cart, there are the following connections: 3.4 3D display
■ 2 × Ethernet ports e The default 26” 3D display has a circularly-polarized, micro-polarizing fil-
■ 1 × HDMI output port f ter that displays the right and left image alternately. Circularly-polarized
■ 1 × HDMI input port g glasses are worn to ensure that the left eye only sees the left image and
■ 1 × SDI input port h the right eye only sees the right image. The 3D display has a refresh rate
■ Main power cord connection i of 60 frames per second (FPS) simultaneously for each eye. The display
comes optimally pre-configured from the factory.
■ 6 mm potential equalization port j
► If the display settings are causing inadequate visualization, please con-
Connecting a secondary display (output) tact customer support for assistance.
The system can support simultaneously displaying the live view on multi-
ple displays. 3.5 3D display stand (optional)
The following 3D displays are approved for use with the DSM: 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
Art. no. Designation optional display can be the primary display.
The following display stands are approved for use with the DSM:
PV008 26” display
PV646 32” display Art. no. Designation

PV644 31” 4K display PV016 Monitor stand for 55" monitor

PV015 55” 4K display PV818 Mobile monitor stand

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3.6 Touchscreen ► Change the batteries of the footswitch when the battery indicator
The system can be controlled by using the touchscreen. The touchscreen is flashes orange, see Chapter 5.12.
2D only and not sterile.
3.7.3 Backup USB cable
► Position the touchscreen for quick and convenient access.

3.7 Footswitch PV014

The system can be controlled by using the wireless footswitch. The foot-
switch is uniquely paired with the DSM system in the DSM software “Foot-
switch” settings panel, see Chapter 6.8.11.
3.7.1 Default footswitch button functionality
a f
b g
Fig. 7
Alternatively, the footswitch can be powered by the 4.5 m optional backup
cable.
3.8 Isolation transformer
The system contains a medical-grade isolation transformer to ensure
patient and product safety. The transformer is configured at the factory to
accept 100 V AC, 120 V AC, or 220 V AC to 240 V AC from the supply
mains. The DSM computers, 3D display, and touchscreen are connected
directly to the isolation transformer. The isolation transformer is con-
nected to the outlet power source – the isolation transformer outlet plug
is the mains disconnect device. The isolation transformer prevents out-
ages, sags, surges, and bad harmonics.

3.9 Wireless keyboard

The system includes a wireless keyboard with an integrated touchpad. The
c h
wireless keyboard is rechargeable. There are no batteries to be replaced. A
three-hour charge provides up to ten days of use when typing about two
d i hours a day with the backlight on, or about one year without backlight. The
backlight is off by default. When the keyboard is turned on, the battery
indicator shows the charge level.
e j
Indicator Description
Fig. 6 Blinking green The battery is charging.
Legend Solid green The battery has adequate charge, or charging is
complete.
a Waypoint save/delete f Waypoint select/move
b Auto focus g Lock-on mode toggle Blinking red Battery power is low. Recharge the battery.
c Focus - h Focus + ► To charge the battery, connect the keyboard to a USB port a on the side
d Zoom - i Zoom + of the touchscreen mount using the Micro-USB cable supplied, see
e White light - j White light + Fig. 5.
The footswitch button commands can be customized in the DSM software The battery indicator blinks green while charging.
“Footswitch” settings panel, see Chapter 6.8.11. ► Charge until the indicator light stops blinking.

3.7.2 Footswitch status LEDs Note

The keyboard can be used while it charges.
Symbol State Designation
Note
Solid Radio connection established, footswitch
If the battery power is low (indicator blinking red), the keyboard backlight
Connection green engaged
is disabled.
Blinking No radio connection, e.g. radio range error
green or receiver not online 3.10 Polarized 3D glasses
Blinking Pairing mode active Passively, circularly-polarized glasses are needed to see the display in 3D.
red Follow pairing instructions, see The glasses may be worn over prescription glasses. Keep the glasses clean
Chapter 6.8.11. and free of scratches. To ensure optimal image quality, the system should
Off Footswitch in power save mode only be used with Aesculap-supplied 3D glasses. Polarized prescription
glasses will distort the 3D effect and should not be used.
Solid Warning 1: “Battery low”
► Contact Aesculap if additional pairs are required.
orange Battery voltage = 3.3 V to 3.2 V (± 10 %)
Battery The following 3D glasses are approved for use with the DSM:
Blinking Warning 2: “Battery low”
orange Battery voltage ≤ 3.2 V (± 10 %) Art. no. Designation
Fast blink- Battery is empty: No further operation is PV621 3D polarization glasses
ing orange possible.
Battery voltage < 3.0 V (± 10 %) PV622 3D anti-fog glasses

Off Depending on Connect LED: PV623 3D polarization glasses with clip

Connect LED ON: Battery voltage > 3.55 V PV624 3D eye shield glasses kit
Connect LED OFF: Footswitch in sleep mode

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3.11 Additional components 5. Working with the product
The DSM system comes with additional components to help configure the
system to work best in the operating room. Risk of injury and/or product malfunction due to
incorrect operation of the electromedical system!
Art. no. Designation Function WARNING ► Adhere to the instructions for use of any medi-
FS095 Mains cord Switzerland cal device.
orange angled
FS096 Europe 5.1 Transport
FS097 Great Britain and Ireland ► Do not push the product while transporting. Only pull the product,
especially over elevator and door thresholds.
FS098 Japan, USA, Canada
PV012SU DSM sterile drape Sterile drape for the head and robotic 5.2 System set-up
arm, sold separately. Single use only 5.2.1 3D display and robotic arm workspace
PV030 White balance White-balancing the DSM head image To help with positioning the DSM in the operating room, the cart dimen-
card sensors. The reverse side of the card is sions, the minimum and maximum extensions of the 3D display arm, and
used for checking the focus and align- the height and maximum extension of the robotic arm are shown below.
ment of the DSM head optics.
PV032SU DUV 400 refer- For checking the functionality of the
4m ,03 m
ence card DUV 400 imaging module (optional). a = 2,3 b=2
Single use only for accuracy check
TA015635 Lens cap Protecting the lens of the DSM head
when it is being stored
,47 m
Aesculap doesn’t provide a sterile drape for the DSM cart. If required, the c=1
sterile drape should meet the following recommendations:

Minimum height 30 cm
Maximum height 75 cm
Minimum width 70 cm d = 1,86 m
Maximum width 115 cm
Additional recommenda- ■ Must not hang over the castors 4m
1,2
tions e=
■ Must not cover the cart vents

4. Preparation and setup

Non-compliance with the following instructions will preclude all respon-
sibility and liability in this respect on the part of Aesculap. Fig. 8
► When setting up and operating the product, adhere to Legend
– national regulations for installation and operation, a Max. length (arm fully extended)
– national regulations on fire and explosion protection. b Max. monitor height
Note c Min. monitor height
For the safety of patients and users it is essential that the mains power cord d Highest point (roll through doors)
and, especially, the protective earth connection are intact. In many cases e Radius
defective or missing protective earth connections are not registered imme-
diately.

► Connect the device via the potential equalization terminal j at the front
of the cart to the potential equalization system of the room used for
medical purposes, see Fig. 5.
Note
The potential equalization lead can be ordered from the manufacturer as
art. no. GK535 (4 m length) or TA008205 (0.8 m length).

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There are two recommended layouts for the operating room. Also note that any equipment connected at the interfaces must demon-
strably meet the respective IEC standards (e.g. IEC 60950 for data process-
Neurosurgery operating room layout (example)
ing equipment, IEC/DIN EN 60601-1 for electromedical devices).
All configurations must comply with basic standard IEC/DIN EN 60601-1.
b
Any individual 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.
► Please address the B. Braun/Aesculap partner or Aesculap Technical
a Service with any inquiries in this respect; for a contact address, see
Chapter 10.
► Every time a new piece of equipment is added and cables are connected
to the DSM system, power down the system prior to connecting cables,
then power it back up once the cables are connected.
c
5.2.3 Connecting the power supply

Risk of fatal injury from electric shock!

► Connect the product only to a grounded power
DANGER supply.

Fig. 9 ► Connect the main power cable to a hospital-grade power outlet. Do not
Legend use un-approved extension cords or power strips. Use uninterruptible
power source when loss of power would result in an unacceptable risk.
a Surgeon
► Lay the power cable in areas with minimal foot traffic.
b Assistant
c Scrub nurse 5.3 Function checks
Spinal surgery operating room layout (example) Before turning the DSM system on
► Check that the castors are locked once the cart is in the desired loca-
c a tion. Make sure the cart is stable and cannot roll in any direction.
► Connect the main power cable, see Chapter 5.2.3.
► Connect any external input or output video or Ethernet cables, see
Chapter 3.3.3.
► Check that there are no unnecessary objects or people within the range
of the robotic arm workspace.
► Check that the DSM head 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
b
► Position the yaw coupler as desired, see Chapter 6.2.1.
► Move the robotic arm from “Storage” to “Drape” position, see
Chapter 6.2.1.
► Follow the instructions printed on the drape packaging to correctly
Fig. 10 apply the drape to the DSM head and robotic arm.
► Position DSM at the OR table.
Legend
► Position the 3D display for the surgeon’s viewing preference.
a Surgeon
► Check that the “Zoom”, “Focus”, and “White Light Level” handle buttons
b Assistant
are functioning properly.
c Scrub nurse
► Check that the 3D image colors, focus, and alignment look correct.

5.2.2 Connecting the accessories
Risk of injury due to unapproved configuration
using additional components!
DANGER ► For all applied components, ensure that their
classification matches that of the application
component (e.g. Type BF or Type CF) of the
respective device.
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.
► 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 (DUV 400), check the fluorescence
module using a reference card to ensure proper working order.
5.4 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:

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b = 2,03 m

c = 1,47 m

a
Fig. 13
Legend
Fig. 11
a Sliders of the yaw coupler
Legend
a Top of the screen ► Unlock the sliders a and rotate the DSM manually into the desired posi-
b Max. monitor height (top of the screen) tion.
c Min. monitor height (top of the screen) The available coupler positions are illustrated below. The geometry lim-
its of the robotic arm will change based on the coupler position.
5.5 Turning the system on -90° 0° 90°
► Perform the relevant items of the function checks, see Chapter 5.3.

Fig. 14

a
Fig. 12
Legend
a Main power button
► Press the main power button a located on the back panel of the DSM
cart, next to the power cable connection and LED indicators.
The displays, head, 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 DSM software has opened
and the notification “DSM initializing, please wait…” is no longer dis-
played.
5.6 Setting up the robotic arm and the DSM head
5.6.1 Rotating the DSM using the yaw coupler
Depending on the surgical approach and operating room layout, it may be
advantageous to rotate the DSM head 90° to the left or right.
Note
Only adjust the yaw coupler before draping, using the proper “Reconfigure
Coupler” workflow. Do not adjust the yaw coupler during surgery.
► Once the system has fully started up, go to the “Robot” tab in the DSM
home screen, see Fig. 22.
► Under “Coupler”, press the “Reconfigure Coupler” button.
► Press and hold the “Hold or Reconfigure position” button until the arm
is fully extended.
► Press the “Hold for Drape position” button in the DSM software until
the movement is finished.
5.6.2 Moving the robotic arm out of storage position and draping
the robotic arm
The DSM head and distal portion of the robotic arm must be draped using
the provided Aesculap sterile drape PV012SU prior to surgery.
Note
Additionally, the DSM cart may be draped at the user’s discretion (cart
drape not provided by Aesculap). For drape dimensions, see Chapter 3.11.
► Once the system has fully started up, move the robotic arm into the
“Drape” position, see Chapter 6.2.1.
► Once the DSM is in the “Drape” position, follow the instructions printed
on the drape packaging to correctly apply the drape to the DSM head
and robotic arm.
► If the drape affects the balance of the robotic arm, rebalance the DSM,
see Chapter 6.2.2.
► Perform all the remaining items of the function checks before starting
the surgery, see Chapter 5.3.

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5.7 Starting a case ► Press “Yes” to continue saving the media information.
Once the DSM arm has been draped and all pre-operative checks are com- – or –
plete, a new case can be started. ► 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.

Fig. 15

► Select a surgeon profile and a patient in the “Case” tab.

– or –
► Add a new Surgeon profile or Patient by using the Add button.
DSM settings and preferences are saved for each Surgeon profile.
The Delete button is disabled when the “Default Surgeon” or Fig. 17
“Default Patient” is selected, but it can be used to delete custom pro-
files. ► Enter a first and last name, then press Next button to continue, or
Cancel button to return to the “Save Recorded Media?” message.
► When the DICOM settings are configured to a networked database,
select the “DICOM” toggle and search for a patient. To search all listed ► Press the pencil button to add or update “Optional Patient Data”.
patients in the database, enter an asterisk (*) in the first and last name This option is enabled once a first and last name have been entered.
search fields. ► Press OK button when done editing to proceed.
► Once the desired surgeon and patient have been chosen, press “Start
Case” to advance to the live screen, see Chapter 6.3.

5.8 Ending a case

► Select the End Case button to end the current case.
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.

5.9 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.

5.9.1 Save to default location Fig. 18

After selecting to end the case: 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.

Fig. 16

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5.9.2 Copy media to drive
Fig. 19
► 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 con-
firmation 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.
5.10 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 6.2.1.
► Release the stripes on the drape bag.
► Detach the adapter from the camera head.Invert and remove the drape
along the robotic arm.
► Dispose the sterile drape in compliance with medical waste regulations.
5.11 Shutdown procedure
For safety, it is important to follow proper shutdown procedure when the
DSM system is not in use. The software will need to be shut down, the
robotic arm will need to be moved into storage position, and the system
power should be turned off with the main power button.
5.11.1 Software shutdown and robotic arm storage
► 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 6.2.1 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. 20
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5.12 Changing footswitch batteries
Battery type: 3 × IEC- LR14 (Type C – “Baby”)
► Shut down DSM, see Chapter 5.11.
► 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).
► Close battery housing: rotate both lockers back to original position.
6. Software
6.1 Home screen
The DSM software starts on the home screen on the touchscreen.
Fig. 21
Symbols
Protective stop
As a risk control, the software has a protective stop button in
the unlikely scenario that the robotic arm moves in an unpre-
dictable way. The protective 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
(On, movement disabled).
Press the button again to remove the protective 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.
TrueMedia application
Select the TrueMedia application playback button to view or
edit surgical content. The DSM 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.
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6.2 DSM setup 6.2.2 Rebalance scope
The “Setup” panel in the home screen provides the following functions: Moving the robotic arm to its limits can affect the DSM’s balance. To cor-
■ Move the robotic arm to a preset position rect the presence of any drift, the DSM can be rebalanced.
■ Rebalance the DSM The DSM robotic arm is factory-calibrated. It is recommended to rebalance
the robotic arm once annually or as needed, especially if the robotic arm
■ Enter recovery state feels unbalanced during movement with the handle brake-release buttons.
■ Reconfigure the coupler. ► Ensure the area of the robotic arm is clear.
Note ► Press “Rebalance Scope” in the “Setup” tab.
Setup should always take place before surgery. 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 DSM still results in unsatisfactory balance, con-
tact Aesculap Technical Service for assistance, see Chapter 10.

6.2.3 Robot recovery

If communication is lost with the force-torque sensor or the coupler and
the robotic arm becomes difficult or impossible to move, the arm joints
need to be manually repositioned.
► Press and hold “Robot Recovery” in the “Setup” tab.
► Manually reposition of the arm joints.

6.3 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 DSM head,
Fig. 22
robotic arm, recording, fluorescence, and access to settings.
6.2.1 Preset positions
The available preset positions are:
■ Drape
■ Storage

a = 450 mm
b = 1 240 mm

Fig. 24

6.3.1 Zoom, focus, and light controls

Fig. 23 The “DSM” tab within the “DSM Control” panel shows controls for zoom,
Legend focus, white light levels, and DUV light levels (if licensed). The DSM control
a Keep this area clear vertically during position change values can be adjusted by using the handles, footswitch, or the touch-
b Keep this area clear horizontally during position change screen.
► Press anywhere on the value bar or press and drag the slider to change
Risk of injury due to unintended movement of the the values.
robotic arm! ► Select the or buttons for fine tuning.
WARNING ► Make sure the area surrounding the robotic arm
is clear of objects or people. Setting Range
► Watch the robotic arm while it is moving.
Zoom 1.00 × to 10.00 ×

► Select a pre-configured position for the robotic arm in the “Position” Focus 200 mm to 450 mm
drop-down list. White Light 0 % to 100 %
► Press the “Press and Hold to auto-position” button until the robotic
arm movement fully stops in position. DUV Light 0 % to 100 %

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6.4 Fluorescence controls 6.5 Touchscreen robot control
Note
Fluorescence module (DUV 400) requires a license for use with the DSM sys-
tem.

DUV 400: The integrated DUV 400 fluorescence module of the DSM is
used to visualize near-UV fluorescent areas in the surgical field. The mod-
ule 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 fluorescence. In addition to
visualization, users can record fluorescent and auto-fluorescent light
emitted by tissue by enabling the “Overlay” feature.
Fluorescence controls can be adjusted by using the handles, footswitch, or
touchscreen.
Note
The “Autofocus” feature is disabled while fluorescence function DUV 400 is
Fig. 25
enabled. Use the touchscreen, handles, or footswitch to manually refocus
the target image. The robotic arm pan and rotation movements can be controlled from the
“Robot” tab in the “DSM Control” panel in precise, single-axis movements.
6.4.1 Function checks Each arrow (Forward, Back, Left, Right, Up, and Down) corresponds to a
directional movement in relation to the DSM head.
The fluorescence reference card and the touch-
screen are not sterile! Holding down one of the directional arrow buttons moves the robotic arm
until a joint limit is reached. Directional movements can also be employed
WARNING ► Perform fluorescence functional tests before
by configuring the corresponding commands to the handle buttons (see
surgery.
Chapter 6.8.10) or footswitch buttons (see Chapter 6.8.11).
► Before starting fluorescence visualization, always check the function-
6.5.1 Lock On Target
ality of the integrated fluorescence module.
The “Lock On Target” function locks the DSM onto a selected focal target
► Ensure that the DSM system is in a dark room, with no other illumina-
in the live image. When enabled, directional movement will rotate around
tion other than the DSM integrated lighting and the system displays.
the focal target instead of moving linearly. Up and Down directional
► Place the reference card on a level surface. movement remains unchanged while “Lock On Target” is enabled.
► Set the focus to 325 mm and the zoom to 5 × on the touchscreen. “Lock On Target” does not apply when moving the DSM by using the han-
► Refocus the image by moving the DSM head upwards or downwards dle brake-release buttons, even when enabled. After such a movement,
using assisted drive. Lock On Target movement will resume as long as it is enabled.
► Activate the fluorescence function by selecting the “DUV 400 On” but- ► Press the “Lock On Target” button to activate/deactivate the function.
ton on the touchscreen or the corresponding handle or footswitch but-
ton. 6.5.2 Robot Speed
► In the live image, check the following: If the slider position is closer to “Min” (minimum), the robotic arm move-
– DUV 400: There is distinct contrast (orange/pink) between the DUV ment will be slower, and if the slider position is closer to “Max” (maxi-
400 reactive compound and the reference card (green/white). mum), the robotic arm movement will be faster.
– The reactive compound must be clearly distinguishable and the live ► Change the speed of the robotic arm movement by clicking anywhere
image should not be washed out. Slight deviations in color and on the “Robot Speed” bar or by clicking and dragging the slider.
brightness are acceptable.
6.6 Quick Access Bar (QAB)
6.4.2 DUV 400 imaging The Quick Access Bar (QAB) can be configured to show the top four most-
The following factors influence the visualization of the fluorescence sig- used available functions in the home and live screens, as well as while in
nal: fullscreen.
■ Fluorescence medium and its concentration in the tissue
■ Illumination intensity of the light source in the defined wavelength
range (both blue and white light)
■ Transmission of the optical system Fig. 26
■ Working distance and the illuminated field diameter
■ DSM white light level ► Edit the QAB by selecting the pencil button and toggling on or off
► Activate the fluorescence function by selecting the “DUV 400 On” but- the available functions.
ton on the touchscreen or the corresponding handle or footswitch but- Selected QAB functions are highlighted in green and are added to the
ton. bar by order of selection.
The “DSM Control” panel will still be available and – additionally – the
“DUV Light Level” value bar can be adjusted while DUV 400 is on.
► 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.

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The following QAB functions are available:
State Icon Description
Function Description Footswitch Directional Displayed when moving the arm
Viewport Configure the format for multiple inputs on screen. Move with Restrictions with the footswitch and arm reaches
Select between primary input, secondary input, split a directional limit
screen, or picture-in-picture. Configure a second video Handle Directional Move Displayed when moving the arm
source in the input settings. with No Restrictions with the handle buttons and there
Swap Sources Switch between the primary and secondary input in the are no movement restrictions
main view. Handle Directional Move Displayed when moving the arm
Orientation Toggle the orientation of the primary input between Approaching Restric- with the handle buttons and arm
standard and inverted 180 degrees. tions approaches directional limit

Digital Aper- Toggle a digital aperture that blocks out the periphery Free Drive State Displayed when robot arm is in “Free
ture of the image. Adjust the size and transparency in the Drive State”
“Digital Aperture” settings, see Chapter 6.8.3.
Pre-Programmed Posi- Displayed when arm is moving to a
Autofocus Select to automatically focus the object in the center of tion Move pre-programmed position
the DSM image.Start the autofocus by:
Assisted Drive Move Displayed when moving the arm
■ Pressing an appropriately configured handle button,
with No Restrictions with the handles and there are no
see Chapter 6.8.10 movement restrictions
■ Pressing an appropriately configured footswitch
Assisted Drive Move Displayed when moving the arm
button, see Chapter 6.8.11
Approaching Restric- with the handles and arm
Note tions approaches directional limit
If “Auto-focus After Move” in the “Camera” settings panel is disabled, the Assisted Drive Move Displayed when moving the arm
focal target will not be reassessed after manual movement while “Lock On with Restrictions with the handles and arm reaches a
Target” is enabled. To refocus image manually, use the touchscreen, han- directional limit
dles, or footswitch.
Uncalibrated State Displayed when arm hasn’t been cal-
ibrated
6.7 Robotic arm state indicators
The robotic arm has defined force, speed, and geometric limits for safety. Handle Directional Move Displayed when moving the arm
As the arm approaches a limit, the indicator shown in the lower right of with Restrictions with the handles buttons and arm
the live screen will change its icon and color. reaches a directional limit

Specification Limit GUI Directional Move Displayed when moving the arm
with No Restrictions from the user interface and there are
Force 250 N no movement restrictions
Speed 1 m/s GUI Directional Move Displayed when moving the arm
Approaching Restric- from the user interface and arm
The Indicator states are pictured and described in the table below: tions approaches a directional limit

State Icon Description GUI Directional Move Displayed when moving the arm
with Restrictions from the user interface and arm
Initializing State Displayed during initial power ON, or reaches a directional limit
when arm is initializing
Failure State Displayed during a hardware mal-
Ready State Displayed when arm is ready for function
movement
Coupler in Unlocked Displayed when coupler in Unlocked
Emergency Stop State Displayed when Emergency Stop Position position and while changing coupler
button is engaged orientation

Protective Stop State Displayed when the robot is in a pro- Note

tective stop state after the arm
movement is interrupted
Soft Stop State Displayed when soft stop state is
selected
Footswitch Directional Displayed when moving the arm
Move with No Restric- with the footswitch and there are no
tions movement restrictions
Footswitch Directional Displayed when moving the arm
Move Approaching with the footswitch and arm
Restrictions approaches a directional limit
In the unlikely event that the robotic arm becomes difficult to move near a
geometric limit, it is recommended to move the robotic arm back to a preset
position (e.g. Drape).
6.8 Software settings
► Select the Settings button to open system settings panels.
The “Camera” settings panel will open by default the first time the set-
tings are accessed.
After that, the last used panel will be opened in subsequent accesses.
Selecting a different Settings button will automatically save any
changes made and switch panel.
Selecting the More Settings button reveals additional settings panels.

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Commonly found buttons in the settings panels include: DSM Settings
The “DSM Settings” drop-down list has the following options:
Icon Description
Option Description
Exit panel without saving changes made to current panel.
Auto-Hide The DSM control values (Zoom, Focus, and White Light)
(default) will be displayed over the live surgery screen for ~5 sec-
Reset the current panel to its default settings. onds and then hidden after adjusting the values.
(Not present for DICOM or Input panels.) Show The DSM control values will always been shown on the
surgery screen(s).
Save changes and close panel.
Hide The DSM control values will never be shown on the sur-
gery screen(s).
6.8.1 Camera settings
6.8.3 Digital Aperture
In the Camera settings panel the following settings of the DSM camera
The Digital Aperture feature enables a digital overlay where the live
can be modified:
image can be restricted to a circle in the center of the screen, with a dark
■ Orientation mask covering the rest of the image.
■ Auto-exposure ► Press the toggle button to disable (default) or enable the feature.
■ Auto-focus After Move
Diameter
Orientation ► Use the “Diameter” bar to select or slide the value anywhere between
The Orientation drop-down menu has the following options: 0.05 (smallest diameter) and 1.00 (largest diameter).
■ Standard (default, used for most configurations of the DSM head to The default Diameter is 0.75.
match the surgeon’s view)
■ Rotated (180° view from Standard orientation) Opacity
► Use the “Opacity” bar to select or slide the value anywhere between
The orientation applies to all connected monitors, unless “Assistant” view
0.05 (most transparent mask) and 1.00 (most opaque mask).
is being used; see Chapter 6.8.7 for more information on “Assistant” view
settings. The default Opacity is 0.50.

Note 6.8.4 DUV 400 (Fluorescence)

The DSM handle button layout will rotate if the view is set to "Rotated" in In the DUV 400 panel the following settings for the DUV 400’s overlay
software settings. can be modified:
■ Hue: can be adjusted on a range of yellow to blue (default: green)
Auto-exposure
When “Auto-exposure” is enabled, the live view automatically adjusts for
■ Opacity: can be adjusted from 0 to 100 (default: 100)
changing lighting conditions and is especially effective in reducing red ■ “Auto-Overlay”
color saturation. “Auto-Overlay”, when enabled, transitions from DUV 400 to Overlay after
When “Auto-exposure” is disabled, no adjustments to the live image will a set amount of time. “Overlay Mode Timer” can be adjusted from 1 to 60
be made. seconds. By default, “Auto-Overlay” is disabled and “Overlay Mode Timer”
is set to 30 seconds.
► Press the “Auto-exposure” toggle to disable (default) or enable the fea-
ture. 6.8.5 Color
Auto-focus After Move In the Color panel the following settings can be modified:
If “Auto-focus After Move” is enabled and the DSM is moved via any ■ Gain: can be adjusted from 0 to 80 (default: 0)
method, once the DSM stops movement the software will automatically ■ Picture: adjust Brightness, Contrast, Gamma, Hue and Saturation
refocus on the current focal point. ■ White Balance
When this feature is disabled, manual adjustment to achieve ideal focus
will be required (using the handles, footswitch, or touchscreen). Picture
► Select the “Auto-focus After Move” toggle to enable (default) or dis- Note
able the feature. These are advanced settings. It is not recommended to change these set-
tings.
6.8.2 Screen Layout
► Select the desired quality setting by pressing or pressing and dragging
In the Screen Layout settings panel the following settings of the DSM
the slider on any of these settings:
camera can be modified:
– Brightness: determines the intensity of the color in the live image
■ Picture in Picture (PiP) Location (range: 20 to 80, default: 48)
■ DSM Settings – Contrast: difference between the lightest and darkest regions of the
Picture in Picture (PiP) Location live image (range: 20 to 80, default: 55)
The “PiP Location” drop-down menu has the following options: – Gamma: non-linear operation used to encode and decode lumi-
■ Bottom Right (default) nance of the live image (range: 0.50 to 5.00, default: 1.20)
■ Top Left – Hue the degree to which a stimulus can be described as similar to
or different from stimuli that are described as red, green, blue, and
■ Top Right yellow (range: -180 to 180, default: 2)
■ Bottom Left – Saturation: the amount of white mixed into the hue (range: 0 to
300, default: 90)
► To return to the original settings, press the “Default” button.

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White Balance
Every DSM is shipped with pre-configured white balance settings.
Note
These settings may not be optimal for the specific lighting conditions.
► To reset the white balance to the factory settings, press “Reset to Fac-
tory WB” button.
For the best image, the DSM should be white-balanced.
► Set the DSM light to the surgeon’s normal working conditions.
► Place the white balance card PV030 under the light. Ensure that the
entirety of the live view is filled by the card. Never use gauze, tape,
sheets, or other fabrics which may have been bleached.
► Tilt the card and move it either closer or farther from the light as the
software instructs.
► Select White Balance button to perform white balance and follow
the on-screen instructions to complete the white balance process.
► Test the colors by viewing your hand under the DSM. Repeat the pro-
cess if the colors look incorrect.
6.8.6 Recording
In the Recording panel the following settings can be modified:
■ Movie or snapshot file formats
■ Auto-record
■ Fullscreen recording
■ Frame rate
■ Movie quality
■ DICOM 3D recording
Note
Recording settings cannot be changed while recording a case.
Basic settings
Note
Fullscreen recording is not recommended due to possible delays in the
image.
► Select the desired recording settings:
– Movie format: Press the radial button of either “AVI” or “MOV”
(default: MOV).
– Auto-Record: check the checkbox to have the software start record-
ing as soon as “Start Case” is selected (default: unchecked).
– Fullscreen: Check the checkbox to record the surgery screen with all
annotations and overlays. If unchecked, the software will only
record the raw DSM input (default: unchecked).
– Snapshot format: Press the radial button of either “JPEG” or “PNG”
(default: JPEG).
Advanced settings
Note
Increases or decreases to frame rate and quality can be expected to have
relative increases or decreases to file size.
► Select the desired advanced recording settings:
– Frame rate: frames per second that will be captured during a
recording. Select the desired frame rate by pressing or pressing and
dragging the slider from any value between 30 fps and 58 fps
(default: 45 fps).
– Quality: can be adjusted from 0 to 10, resulting in respective
changes to recording quality. Notably, minimizing the slider can
introduce compression elements such as haloing or blurry frames to
the recording with the benefit of reducing file size. Select the
desired quality setting by pressing or pressing and dragging the
slider from any value between 1 and 10 to change the quality for
recordings (default: 5).
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– Squeezed SxS (side by side): checking the checkbox reduces resolu-
tion of saved media to 1920 × 1080 (default: unchecked). Select
this option when smaller file sizes and/or the ability to edit with 3rd
party editing software are required.
– DICOM Record 3D: when a DICOM patient is selected at the start of
a case, all media recordings will be in 2D by default. Check the
checkbox to record all DICOM case media in 3D. Uncheck the check-
box to record in 2D again.
Note
Non-DICOM patient case media are in 3D by default, therefore the “DICOM
Record 3D” feature is disabled when a non-DICOM patient is selected.
6.8.7 Display
In the Display panel certain display settings can be modified, including
the view type, 3D format, and polarity of connected monitors (see
Chapter 3.3.3 for a list of compatible displays).
Identification information (numeric identifier, model number, 3D format,
polarity, resolution, and view type) will automatically appear on the live
image of each connected monitor while the Display settings panel is open.
Note
For displays intended for use (see Chapter 3.3.3), the 3D format and polarity
(“Swap 3D”) are automatically detected and set to their ideal pre-configu-
rations, as long as “Detect” remains enabled with the default panel settings.
► To return to the ideal pre-configuration after making changes, select
“return to defaults” button, then ensure “Detect” is enabled.
Detect
► Press the “Detect” button to turn this feature on or off.
Detect is set to “Off” by default to allow the software to automatically
configure the connected displays to their saved settings.
Display List
► To view or manually modify settings for a specific display, select the
corresponding numeric identifier for that display from the “Display”
drop-down list.
View
► Press the “View” drop-down list to assign a view type to the selected
display.
The available view types are:
■ Control
■ Surgery
■ Assistant 180
■ Assistant 90 CW
■ Assistant 90 CCW
“Surgery” view is a non-interactive secondary view with the primary func-
tion of displaying the live image. “Surgery” view will display relevant noti-
fications as they appear on the “Control” view.
“Assistant 180", “Assistant 90 CW” (clockwise), and “Assistant 90 CCW”
(counter-clockwise), are “Surgery” views that are rotated as indicated.
Note
At least one display must be assigned a “Control” view type. The touch-
screen display is assigned as the “Control” view by default.
3D Format
► When “Detect” is set to “Off”, press the “3D Format” drop-down list to
change the 3D format for the selected display from the following avail-
able options:
– Monoscopic
– Row-Interleaved
– Side-by-Side
– Top-Bottom
– Dimenco
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Swap 3D ► Exit out of the DSM software onto the Windows Desktop, see
“Swap 3D” switches the left and right eye polarity and can be used to help Chapter 5.11.
determine if the monitor is using the correct 3D polarity setting. ► Configure Ethernet connection using the Windows Control Panel.
► To check the polarity, close the right and left eye alternatively while
wearing 3D glasses and ensure the on-screen “Left” and “Right” text 6.8.10 Handles
matches the eye opened. In the Handles panel the layout and functions of the DSM head handles
using can be customized.
6.8.8 Input Source ► Press the “Left–Right” toggle to switch between handles.
In the Input Source panel external display devices, such as an endo- ► See below for a list and description of each button’s function.
scope, can be configured to the correct input type.
The available input source types are: Dual Mode
► Press the “Dual Mode” checkbox to enable/disable this function.
■ SDI
When Dual mode is enabled, both handles share the same configura-
■ HDMI
tion. Two Dual mode setups can be configured, A and B, and toggled
“Viewport 1" is set to the 3D live image from the DSM head.“Viewport 2" between. The A–B toggle is only accessible when “Dual Mode” is
can be configured to display either SDI or HDMI input from connected enabled.
external devices. Both SDI and HDMI devices can be connected simultane-
ously, however only one type can be displayed at a time. Available handle button functions
► Press the corresponding radial button of the desired input type.
Button description Functionality
The following Aesculap camera systems are supported by the DSM:
None No Function
Art. no. Supported settings Autofocus Microscope will automatically focus on the
center of the field of view.
PV460 60 Hz signal, DVI output on PV460, SDI input on DSM
Button Layout Map Displays the current button layout.
PV470 50 Hz signal, DVI output on PV470, HDMI input on DSM
Cycle DUV 400 Toggle to a blue-light filter to intraoperatively
PV480 50 Hz or 60 Hz signal, DVI output on PV480, HDMI or SDI differentiate between diseased and healthy tis-
input on DSM sue after a 5-ALA injection.
DUV Light Down Reduce the amount of light while DUV 400
6.8.9 DICOM mode is on.
DUV Light Up Increase the amount of light while DUV 400
mode is on.
Digital Aperture Tog- Toggle digital aperture overlay. Diameter and
gle Opacity can be changed in settings.
Focus (+) Move the objective lens closer.
Focus (-) Move the objective lens farther away.
Move (Down) Move the DSM head down.
Move (Up) Move the DSM head up.
Record Start/stop video recording.
Waypoint Save/Delete Press button once to save current location and
Fig. 27 configuration as a waypoint. Hold down button
In the DICOM panel the networking for uploading and downloading to delete selected waypoint.
media to and from a configured server database can be set up. Waypoint Press button to toggle through saved way-
Select/Move points. Hold down button to move to selected
Note
waypoint.
The DICOM module requires a license for use with the DSM system.
Snapshot Take a snapshot.
See DICOM Conformance Statement TA015615-DCS for information
related to the use of DICOM data exchange. Swap Sources Toggle between input sources. Can be config-
ured to either SDI or HDMI.
■ Network and DICOM addresses must be provided by the IT administra-
Lock-on Mode Toggle Toggle lock to target mode.
tor responsible
■ AE titles are case-sensitive Viewport Layout Cycle through available viewport settings. Can
Cycle be configured to “Source 2”, “Picture in Pic-
■ A connection test is automatically run prior to each DICOM upload to
ture”, or “Side by Side” view.
verify both servers are running and accepting the data type being sent
■ The information on the “DSM” tab is static. The settings in “HIS/RIS” White Light (-) Decrease white light.
and “PACS” tabs are editable and can be updated at any time. White Light (+) Increase white light.
Setting up network connection Zoom (+) Increase zoom.
► To set up the initial connection with the hospital network, consult with Zoom (-) Decrease zoom.
local network administrator.
► Connect an Ethernet cable to the hospital network installation and to
one of the Ethernet ports b/e on the cart, see Fig. 5 the system.
► Turn the DSM on, see Chapter 5.5.

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6.8.11 Footswitch More
In the Footswitch panel the footswitch can be paired with the DSM ► Press “More” to open a separate panel with two pages.
and the layout and function of the footswitch can be configured. Page 1 contains system information, including Computer Name, Mac
See below for a list and description of each button’s function. Address, Camera, Licenses, and Software Part Number.
Note Page 2 contains regulatory information.
► Press Back button to return to the main “About” panel.
The footswitch has a red colored status indicator when unpaired.

Pairing the footswitch

► Ensure that the footswitch is in sleep mode and there is no active radio
7. Reprocessing procedure
connection: 7.1 Single-use products
– Do not press switches for at least 2.5 seconds.
– Ensure that all LEDs on the footswitch are off. Art. no. Designation
► Simultaneously press and hold buttons 1 and 2 on footswitch until the PV012SU DSM sterile drape
LED slowly blinks red, then select the Pair button in the DSM soft-
ware.
The fooswitch is ready for pairing. The footswitch LED will blink red Risk of infection for patients and/or users and
until a new dongle is found or until pairing mode times out after ~30 impairment of product functionality due to reuse.
seconds. WARNING Risk of injury, illness or death due to contamination
and/or impaired functionality of the product!
► To stop the pairing process, press “Cancel”.
► Do not reprocess the product.
Once successfully paired, the status indicator in the software will be
green and the footswitch will have a green LED when commands are
sent to the software. 7.2 Preparation before cleaning
A yellow status indicator means the footswitch is paired but inactive ► Remove any visible surgical residues as much as possible with a damp,
(no current command is being sent to the software). lint-free cloth.
A green status indicator means the footswitch is paired and in use (a
current command is being sent to the software).
7.3 Limitations on reuse
The camera housing can be disinfected up to 140 times with the proper
By pressing any of the control components the footswitch changes into
care. Any additional reprocessing falls under the responsibility of the user.
active mode and tries to establish a radio connection with the receiver.
If there is no pressed button or switch for more than 120 seconds, the For the other parts of the DSM there is no set maximum number of uses
footswitch falls back to sleep mode. In this mode all indication LEDs are and reprocessing cycles.
turned off. The life of the product is limited by damage, normal wear and tear, type
and duration of use, as well as handling, storage and transport of the prod-
Available footswitch button functions uct.
The same button functions as for the handle are also available for the foot-
A careful visual and functional inspection before the next use is the best
switch, see Chapter 6.8.10
opportunity to recognize a product that is no longer functional.
6.8.12 About
7.4 Cleaning/disinfection
In the About panel the following system information is shown:
■ Software version 7.4.1 Product-specific safety instructions for the reprocessing pro-
cedure
■ Technical support contact information
■ Language selection Risk of electric shock and fire hazard!
■ Link to the user manual ► Unplug the device before cleaning.
■ Other software and regulatory information DANGER ► Do not use flammable or explosive cleaning or
Language selection disinfecting solutions.
► From the drop-down list, select the desired language, then select Save ► Ensure that no fluids will penetrate the product.
button.
The DSM application will need to restart after changing the language. Damage to, or destruction of the product caused by
mechanical cleaning/disinfection!
► Select Cancel button to keep the current language.
CAUTION ► Only clean and disinfect the product manually.
Note ► Do not sterilize the product under any circum-
Patient data saved in a language other than the current language will not stances.
be displayed.
Damage to the product due to inappropriate clean-
User manual
ing/disinfecting agents!
► Press “User Manual” to open the user manual folder found on the desk-
CAUTION ► Only use cleaning/disinfecting agents approved
top.
for surface cleaning. Follow the manufacturer’s
► Double-click on the DSM user manual to open the PDF version.
instructions for the respective cleaning/disin-
Note fecting agent.
The DSM application does not need to be closed in order to view the user
manual.

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Damage to the product due to inappropriate clean-
ing/disinfecting agents and/or excessive tempera-
CAUTION tures!
► Use cleaning and disinfecting agents according
to the manufacturer’s instructions which
– are approved for plastic material and high-
grade steel,
– do not attack softeners (e.g. in silicone).
► Observe specifications regarding concentration,
temperature and exposure time.

7.5 Wipe disinfection for electrical devices

Phase Step T t Conc. Water quality Chemical
[°C/°F] [min] [%]

I Cleaning RT - - - 55% isopropyl alcohol,

0,25% n-alkyl dimethyl ethyl benzyl ammonium chloride,
0,25% n-alkyl dimethyl benzyl ammonium chloride*
II Wipe disinfection RT ≥2 - - 55% isopropyl alcohol,
0,25% n-alkyl dimethyl ethyl benzyl ammonium chloride,
0,25% n-alkyl dimethyl benzyl ammonium chloride*

RT: Room temperature

* The manufacturer recommends Super Sani-Cloth® Germicidal Disposable Wipe (PDI, EPA register number 9480-4)

Phase I 7.8 Storage and transport

► Remove any visible residues with a disposable disinfectant wipe.

Phase II
► Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
► Observe the specified application time (2 min minimum).

7.6 Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
► Set aside the product if it is damaged.
► Periodically download or delete video files on the system computer to
avoid filling up the storage drive.
The DSM system will not allow the user to make new recordings if the
storage drive is filled up.
7.7 Packaging
► Ensure that the packaging will prevent a recontamination of the prod-
uct.
Fig. 28
► Ensure that the robotic arm is in “Storage” position before moving the
cart, see Chapter 6.2.1.
► Wrap the power cable around its wrapping post and hang the wireless
footswitch from its on the front of the cart.Release the brakes on each
of the four casters and move the 3D display into the position illustrated
above.
► Twist the arm joint handles to lock the arm in place.
► Lock the cart castors after moving the system.

8. Maintenance
Preventive maintenance
The Digital Surgical Microscope does not consist of any device that
requires a regularly maintenance within a defined time frame.
However, in an interval of 12 month a regular repeat inspection is manda-
tory. The repeat inspection has also to be carried out after each kind of
repair, if the device or one component was dropped or damaged or if the
medical device was not used according to its intended use.

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9. Troubleshooting list
9.1 Malfunctions 9.2 Error messages
Malfunction Remedy 9.2.1 Startup errors

Colors look wrong Perform a white balance of the DSM head in the Error message Remedy
software settings. Already initialized Restart the system.
3D looks inverted Switch the 3D polarity in the software settings. If that does not help, contact the
DSM Head Manager failed
local Aesculap representative or
Image is upside- Rotate the DSM head orientation in the software Cursor Manager failed Aesculap Technical Service, see
down settings. Chapter 10.
DSM failed
Hard to see 3D Position the display so that it is directly in front
of the surgeon. Some displays have a small ideal Event Manager failed
viewing angle. Adjust the height and tilt of the
Message System failed
display for the best view.
Core functions failed
DSM head not If the software reports that the DSM head is not
detected connected, check the DSM head cable connection Patient Manager failed
at the EPU and at the DSM head.
Playback Manager failed
Unplug the cable connection at the DSM head
and plug it back in to check if the software is Procedure Manager failed
operating correctly now.
Ensure that the DSM head indicator is green. Recording Manager failed

Light, zoom, or Check that the DSM head power cable is con- Storage Manager failed
focus not working nected. Surgeon Manager failed
Ensure that the DSM head indicator is green.
Restart the system. QAB settings failed
If issues remain, contact Aesculap Technical Ser- Video Capture Manager failed
vice, see Chapter 10.
Widget Manager failed
Display not recog- If a display is turned on after the EPU has started,
nized it may not recognize the display. Invalid init parameters
Check that the display cable is securely plugged Failed to run
into the back of the display.
Restart the EPU.
9.2.2 License error
Spots on the display If the displayed image develops spots that do not
move as the viewing target is moved, the DSM Error message Remedy
head optics may have dust on the viewing sur-
DSM license not found. Contact the local Aesculap representative or
faces. Clean the optics and screen.
Please contact Aesculap Aesculap Technical Service, see Chapter 10.
If the spots remain, the dust may be inside the
for support.
DSM head. Contact Aesculap Technical Service,
see Chapter 10.
9.2.3 Recording errors
Robotic arm not Reboot the system or follow the error messages
working shown on the display. Error message Remedy

Touchscreen not Re-connect the touchscreen. Recording failed. Not Download any videos from the system that
working enough disk space avail- should be kept and delete any extra files to
able. free up space on the computer.
Erasing recordings less Any recordings shorter than three seconds
than [3] seconds. are automatically deleted. Create a longer
recording.
Insufficient space on Download any videos from the system that
external drive. Internal should be kept and delete any extra files to
drive has approx. [time] free up space on the connected drive.
remaining. Recordings will only save locally.
[Drive volume name] Download any videos from the system that
drive connected. Insuffi- should be kept and delete any extra files to
cient recording space. free up space on the connected drive.

22
 USA
9.2.4 DSM head errors 11. Technical data
Error message Remedy 11.1 Performance data, information about standards
DSM head is too hot. The DSM head is overheating. The maximum Weight (unpacked) 454 lbs. / 206 kg
Maximum white light white light setting has been capped at 50%.
reduced to 50%. Turn the system off and allow it to cool when Weight (in crate) 600 lbs. / 272 kg
safe. Dimensions (unpacked, L 32.5” × 48.3” × 76.3” /
Connect DSM head. The system is not connected to the DSM × W × H) 826 mm × 1 227 mm × 1 938 mm
head. Connect the DSM head while the sys- Dimensions (in crate, L × 39.7” × 48” × 71.6” /
tem is off. W × H) 1 008 mm × 1 219 mm × 1 819 mm
Wait 30 seconds and restart.
If the connection is failing, contact Aesculap Power input 100/120/240 V AC, 850 W, 50 Hz / 60 Hz
Technical Service, see Chapter 10. EMC IEC/DIN EN 60601-1-2
Possible image degrada- Frame rate from the DSM head is not accept- Conforming to standard IEC/DIN EN 60601-1
tion detected. able.
Check DSM head cable connections.
Contact Aesculap Technical Service, see 11.2 Ambient conditions
Chapter 10.
Operation Storage and transport

Temperature 10 °C to 35 °C -10 °C to 50 °C
10. Technical Service
Relative 30 % to 90 % 10 % to 90 %
Risk of death for patient and operator due to mal- humidity non-condensing non-condensing
function and/or failure of safety measures! Atmospheric 700 hPa to 1 060 hPa 500 hPa to 1 060 hPa
WARNING ► Do not perform any service or maintenance pressure
while using the product on the patient.
► Do not modify the product.
12. Disposal
Modifications carried out on medical technical Note
equipment may result in loss of guarantee/war- The user institution is obliged to process the product before its disposal, see
CAUTION ranty rights and forfeiture of applicable licenses! Chapter 7.
► For service and repair, contact the local
B. Braun/Aesculap representative. Adhere to national regulations when disposing of or recy-
cling the product, its components and its packaging!
Service addresses
The recycling pass can be downloaded from the Extranet
Aesculap Technischer Service as a PDF document under the respective article number.
Am Aesculap-Platz (The recycling pass includes disassembling instructions for
78532 Tuttlingen / Germany the product, as well as information for proper disposal of
Phone: +49 (7461) 95-1601 components harmful to the environment.)
Fax: +49 (7461) 16-2887 Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
E-Mail: ats@aesculap.de
European Union, disposal is taken care of by the manufac-
Or in the US: turer as a free-of-charge service.
Aesculap Inc.
Attn. Aesculap Technical Services ► Detailed information concerning the disposal of the product is avail-
able through the national B. Braun/Aesculap agency, see Chapter 10.
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA 13. Distributor in the US/Contact in Canada
Aesculap Repair Hotline for product information and complaints
Phone: +1 (800) 214 -3392
Aesculap Inc.
Fax: +1 (314) 895 -4420
3773 Corporate Parkway
Other service addresses can be obtained from the address indicated above.
Center Valley, PA, 18034,
USA

23
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com

Aesculap® – a B. Braun brand SOP-AIC-5001887 (TA015615)

2019-02