B. Braun Aesculap DSM Instructions For Use/technical Description

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Aesculap®

Aesculap Power Systems

USA Instructions for use/Technical description

DSM (Digital Surgical Microscope)

USA

Aesculap®

DSM (Digital Surgical Microscope)

Note

CAUTION: RX only!

Legend

1 3D flat panel display 2 Touchscreen 3 Robotic arm 4 DSM head 5 Medical grade cart 6 Footswitch

The illustrations in these instructions for use (especially illustrations of the software) may deviate from the actual device.

Contents

1. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.1 Symbols on product and packaging . . . . . . . . . . . . . . . . . . . . . . 3

1.2 Applicable to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.4 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.5 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.6 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.1 Light emission risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.2 Fluorescent surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.3 Place of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.4 Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.5 DSM sterile drape PV012SU . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.6 Footswitch PV014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3.1 Robotic arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3.2 DSM head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3.2.1 LED indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3.2.2 Handle buttons (default setting) . . . . . . . . . . . . . . . . . . . . . . . . 6

3.3 DSM cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3.3.1 Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3.3.2 Cart LED indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.3.3 Cart connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.4 3D display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.5 3D display stand (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.6 Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.7 Footswitch PV014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.7.1 Default footswitch button functionality . . . . . . . . . . . . . . . . . . 8

3.7.2 Footswitch status LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.7.3 Backup USB cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.8 Isolation transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.9 Wireless keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.10 Polarized 3D glasses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3.11 Additional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

4. Preparation and setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

5. Working with the product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

5.1 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

5.2 System set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

5.2.1 3D display and robotic arm workspace . . . . . . . . . . . . . . . . . . . 9

5.2.2 Connecting the accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

5.2.3 Connecting the power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 10

5.3 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

5.4 Positioning the 3D display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

5.5 Turning the system on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

5.6 Setting up the robotic arm and the DSM head . . . . . . . . . . . . 11

5.6.1 Rotating the DSM using the yaw coupler. . . . . . . . . . . . . . . . . 11

5.6.2 Moving the robotic arm out of storage position and draping the

robotic arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

5.7 Starting a case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

5.8 Ending a case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

5.9 Saving case media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

5.9.1 Save to default location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

5.9.2 Copy media to drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5.10 Removing the drape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5.11 Shutdown procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5.11.1 Software shutdown and robotic arm storage. . . . . . . . . . . . . . 13

5.12 Changing footswitch batteries . . . . . . . . . . . . . . . . . . . . . . . . . 13

6. Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

6.1 Home screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

6.2 DSM setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.2.1 Preset positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.2.2 Rebalance scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.2.3 Robot recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.3 Live screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.3.1 Zoom, focus, and light controls . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.4 Fluorescence controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.4.1 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.4.2 DUV 400 imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.5 Touchscreen robot control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.5.1 Lock On Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.5.2 Robot Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.6 Quick Access Bar (QAB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.7 Robotic arm state indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

6.8 Software settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

6.8.1 Camera settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.8.2 Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.8.3 Digital Aperture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.8.4 DUV 400 (Fluorescence) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.8.5 Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.8.6 Recording. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

6.8.7 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

6.8.8 Input Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.8.9 DICOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.8.10 Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.8.11 Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6.8.12 About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

7. Reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

7.1 Single-use products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

USA

7.2 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

7.3 Limitations on reuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

7.4 Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

7.4.1 Product-specific safety instructions for the reprocessing

procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

7.5 Wipe disinfection for electrical devices . . . . . . . . . . . . . . . . . . . 21

7.6 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 21

7.7 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

7.8 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.1 Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.2 Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.2.1 Startup errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.2.2 License error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.2.3 Recording errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.2.4 DSM head errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

11. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

11.1 Performance data, information about standards . . . . . . . . . . . 23

11.2 Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

12. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

13. Distributor in the US/Contact in Canada for product

information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Symbol Location Description

Product label Date of manufacture

Product label CSA NRTL Mark

Product label CE marking acc. to DIR 93/42/EEC

Touchscreen mount label

Coupler label Yaw adjustment slider

Cart potential equalization conductor

Product label Marking of electric and electronic

Product label Catalog number

Product label Serial number

USB 3.0 port

Connection point for potential equalization conductor

devices according to directive 2002/96/EC (WEEE), see Chapter 12.

1. General information

1.1 Symbols on product and packaging

Symbol Location Description

Base of cart Main power switch.

Press to turn the system ON. Press again to turn the system OFF

Product label AC input

DSM head DC input

Product label Warning

Product label Risk of electric shock! Do not open.

Robotic arm Take care to avoid injury when in the

vicinity of the display arm or robotic arm.

Support arms Do not exceed load ratings for support

arms.

Product label Follow instructions for use.

Product label Revision

1.2 Applicable to

These instructions for use are applicable to the following products:

Art. no. Designation

PV010 Aesculap DSM (Digital Surgical Microscope)

PV022 Software module DUV 400

PV024 Software module DICOM

PV030 White balance card

1.3 Warnings

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 label System mass

Product label Manufacturer

Emergency stop control device

Indicates a possible threat of material damage. If not avoided, the product may be damaged.

CAUTION

1.4 Intended use

This device is for use with patients undergoing microsurgery within its indications for use.

There is no patient contact intended with this device.

USA

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 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

1.6 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

► 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

2.1 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.

USA

2.3 Place 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.

2.4 Ambient 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

2.5 DSM 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

3.1 Robotic 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.

2.6 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. ► 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 a Max. radius

USA

3.2 DSM 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 a Bottom of DSM head b Min. working distance c Max. working distance

3.2.1 LED indicator

The DSM head has an LED indicator on the back panel. The indicator colors are explained below.

Indicator Description

3.2.2 Handle 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.

b c

lml

Fig.4

Legend

Assisted drive

Zoom +

White light +

Focus -

Auto focus

White light -

Zoom -

Assisted drive

Record

Focus +

Snapshot

Move up

Move left

Move down

Assisted drive

Move forward

Way point save/delete

Move right

Lock-on mode

Waypoint select/move

Move backward

Assisted drive

p q

r s

t u

Blinking blue The DSM head is starting up

Solid green The DSM head is ready for use

Solid yellow A minor error has occurred. See software mes-

sage for details.

Solid red A major error has occurred. User should switch

to a backup system immediately

Fig.3

3.3 DSM 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.

3.3.1 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 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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3.3.2 Cart LED indicators

There are three LED indicators near the base of the cart that display the status of the DSM, system computer (EPU), and robotic arm components. The indicator colors are explained below.

Indicator Description

Solid green The component is ready for use.

Solid yellow A minor error has occurred.

Solid red Warning – the component is not ready for use.

3.3.3 Cart connections

► Connect the display to the HDMI output port c at the back of the cart,

see Fig.5.

► Configure the additional displays in the DSM software “Display” set-

tings panel, see Chapter 6.8.7.

The individual display settings are specially configured at the factory. When the PV644 or PV015 display is used in a high-temperature environment, the brightness of the display backlight is reduced to lower the temperature inside the unit. When this function is activated, the power indicator flashes in amber. It is not recommended to drape the displays.

Connecting a video stream from another device (input)

Video streams from other devices may be connected to facilitate display in conjunction with the 3D image from the 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

► 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.

b c d e f g h i j

Fig.5

On the touchscreen arm, there are the following connections:

■ 2 × USB 3.0 ports a

At the back of the cart, there are the following connections:

■ 2 × Ethernet ports b

■ 2 × HDMI output ports c

■ 2 × USB 2.0 ports d

At the front of the cart, there are the following connections:

■ 2 × Ethernet ports e

■ 1 × HDMI output port f

■ 1 × HDMI input port g

■ 1 × SDI input port h

■ Main power cord connection i

■ 6 mm potential equalization port j

Connecting a secondary display (output)

The system can support simultaneously displaying the live view on multiple displays.

The following 3D displays are approved for use with the DSM:

Art. no. Designation

PV008 26” display

PV646 32” display

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

There are two Ethernet ports on the both the front and back panels of the cart.

► Ensure that the Ethernet cable and connector comply with at least Cat-

5e EIA/TIA-568A-5, preferably Class D values from ISO/IEC 11801:2002 or EN 50173-I:2002.

► Connect an Ethernet cable to one of the Ethernet ports b or e to link

the system with the facility PACS server, see Fig.5.

► Configure the connection in the software DICOM settings. See

TA015615-DCS for the complete DICOM Conformance Statement.

3.4 3D display

The default 26” 3D display has a circularly-polarized, micro-polarizing filter that displays the right and left image alternately. Circularly-polarized glasses are worn to ensure that the left eye only sees the left image and the right eye only sees the right image. The 3D display has a refresh rate of 60 frames per second (FPS) simultaneously for each eye. The display comes optimally pre-configured from the factory.

► If the display settings are causing inadequate visualization, please con-

tact customer support for assistance.

3.5 3D display stand (optional)

The system can support remote 3D displays on a display stand approved by Aesculap. If the default 26” 3D display does not come with the system, an optional display can be the primary display.

The following display stands are approved for use with the DSM:

Art. no. Designation

PV644 31” 4K display

PV015 55” 4K display

PV016 Monitor stand for 55" monitor

PV818 Mobile monitor stand

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3.6 Touchscreen

The system can be controlled by using the touchscreen. The touchscreen is 2D only and not sterile.

► Position the touchscreen for quick and convenient access.

3.7 Footswitch PV014

The system can be controlled by using the wireless footswitch. The footswitch is uniquely paired with the DSM system in the DSM software “Footswitch” settings panel, see Chapter 6.8.11.

3.7.1 Default footswitch button functionality

Fig.6

Legend

Waypoint save/delete

Auto focus

Focus -

Zoom -

White light -

The footswitch button commands can be customized in the DSM software “Footswitch” settings panel, see Chapter 6.8.11.

Waypoint select/move

Lock-on mode toggle

Focus +

Zoom +

White light +

► Change the batteries of the footswitch when the battery indicator

flashes orange, see Chapter 5.12.

3.7.3 Backup USB cable

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 connected to the outlet power source – the isolation transformer outlet plug is the mains disconnect device. The isolation transformer prevents outages, sags, surges, and bad harmonics.

3.9 Wireless keyboard

The system includes a wireless keyboard with an integrated touchpad. The 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 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.

Indicator Description

Blinking green The battery is charging.

Solid green The battery has adequate charge, or charging is

complete.

Blinking red Battery power is low. Recharge the battery.

► To charge the battery, connect the keyboard to a USB port a on the side

of the touchscreen mount using the Micro-USB cable supplied, see Fig.5.

The battery indicator blinks green while charging.

► Charge until the indicator light stops blinking.

3.7.2 Footswitch status LEDs

Symbol State Designation

Connection

Battery

Solid green

Blinking green

Blinking red

Off Footswitch in power save mode

Solid orange

Blinking orange

Fast blinking orange

Off Depending on Connect LED:

Radio connection established, footswitch engaged

No radio connection, e.g. radio range error or receiver not online

Pairing mode active Follow pairing instructions, see Chapter 6.8.11.

Warning 1: “Battery low” Battery voltage = 3.3 V to 3.2 V (± 10 %)

Warning 2: “Battery low” Battery voltage ≤ 3.2 V (± 10 %)

Battery is empty: No further operation is possible. Battery voltage < 3.0 V (± 10 %)

Connect LED ON: Battery voltage > 3.55 V Connect LED OFF: Footswitch in sleep mode

Note

The keyboard can be used while it charges.

Note

If the battery power is low (indicator blinking red), the keyboard backlight is disabled.

3.10 Polarized 3D glasses

Passively, circularly-polarized glasses are needed to see the display in 3D. The glasses may be worn over prescription glasses. Keep the glasses clean and free of scratches. To ensure optimal image quality, the system should only be used with Aesculap-supplied 3D glasses. Polarized prescription glasses will distort the 3D effect and should not be used.

► Contact Aesculap if additional pairs are required.

The following 3D glasses are approved for use with the DSM:

Art. no. Designation

PV621 3D polarization glasses

PV622 3D anti-fog glasses

PV623 3D polarization glasses with clip

PV624 3D eye shield glasses kit

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3.11 Additional components

The DSM system comes with additional components to help configure the system to work best in the operating room.

Art. no. Designation Function

FS095 Mains cord

FS096 Europe

FS097 Great Britain and Ireland

FS098 Japan, USA, Canada

PV012SU DSM sterile drape Sterile drape for the head and robotic

PV030 White balance

PV032SU DUV 400 refer-

TA015635 Lens cap Protecting the lens of the DSM head

Aesculap doesn’t provide a sterile drape for the DSM cart. If required, the sterile drape should meet the following recommendations:

orange angled

card

ence card

Switzerland

arm, sold separately. Single use only

White-balancing the DSM head image sensors. The reverse side of the card is used for checking the focus and alignment of the DSM head optics.

For checking the functionality of the DUV 400 imaging module (optional). Single use only for accuracy check

when it is being stored

5. Working with the product

Risk of injury and/or product malfunction due to incorrect operation of the electromedical system!

WARNING

5.1 Transport

► Do not push the product while transporting. Only pull the product,

especially over elevator and door thresholds.

5.2 System set-up

5.2.1 3D display and robotic arm workspace

To help with positioning the DSM in the operating room, the cart dimensions, the minimum and maximum extensions of the 3D display arm, and the height and maximum extension of the robotic arm are shown below.

► Adhere to the instructions for use of any medi-

cal device.

a = 2,34 m

b = 2,03 m

c = 1,47 m

Minimum height

Maximum height 75 cm

Minimum width

Maximum width

Additional recommendations

30 cm

70 cm

115 cm

■ Must not hang over the castors

■ Must not cover the cart vents

4. Preparation and setup

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap.

► When setting up and operating the product, adhere to

– national regulations for installation and operation, – national regulations on fire and explosion protection.

Note

For the safety of patients and users it is essential that the mains power cord and, especially, the protective earth connection are intact. In many cases defective or missing protective earth connections are not registered immediately.

► Connect the device via the potential equalization terminal j at the front

of the cart to the potential equalization system of the room used for medical purposes, see Fig.5.

d = 1,86 m

e = 1,24 m

Fig.8

Legend a Max. length (arm fully extended) b Max. monitor height c Min. monitor height d Highest point (roll through doors) e Radius

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.

Neurosurgery operating room layout (example)

Fig.9

Legend a Surgeon b Assistant c Scrub nurse

Spinal surgery operating room layout (example)

Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, IEC/DIN EN 60601-1 for electromedical devices).

All configurations must comply with basic standard IEC/DIN EN 60601-1. 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

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.

5.2.3 Connecting the power supply

Risk of fatal injury from electric shock!

► Connect the product only to a grounded power

DANGER

► Connect the main power cable to a hospital-grade power outlet. Do not

supply.

use un-approved extension cords or power strips. Use uninterruptible power source when loss of power would result in an unacceptable risk.

► Lay the power cable in areas with minimal foot traffic.

5.3 Function checks

Before turning the DSM system on

► Check that the castors are locked once the cart is in the desired loca-

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.

Fig.10

Legend a Surgeon b Assistant c Scrub nurse

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 performance and safety characteristics of the products.

After turning the system on and before starting the surgery

► 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

apply the drape to the DSM head and robotic arm.

► Position DSM at the OR table. ► Position the 3D display for the surgeon’s viewing preference. ► Check that the “Zoom”, “Focus”, and “White Light Level” handle buttons

are functioning properly.

► Check that the 3D image colors, focus, and alignment look correct. ► Check that the robotic arm assisted drive is moving smoothly and pre-

dictably.

► Check that the footswitch is paired with the system and the buttons

are working properly.

► If using fluorescence visualization (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:

b = 2,03 m

c = 1,47 m

Fig.11

Legend a Top of the screen b Max. monitor height (top of the screen) c Min. monitor height (top of the screen)

5.5 Turning the system on

► Perform the relevant items of the function checks, see Chapter 5.3.

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Fig.13

Legend a Sliders of the yaw coupler

► Unlock the sliders a and rotate the DSM manually into the desired posi-

tion. The available coupler positions are illustrated below. The geometry lim-

its of the robotic arm will change based on the coupler position.

-90° 0° 90°

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 displayed.

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.

Fig.14

► 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

Once the DSM arm has been draped and all pre-operative checks are complete, a new case can be started.

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

“Default Patient” is selected, but it can be used to delete custom profiles.

► When the DICOM settings are configured to a networked database,

select the “DICOM” toggle and search for a patient. To search all listed patients in the database, enter an asterisk (*) in the first and last name search fields.

► Once the desired surgeon and patient have been chosen, press “Start

Case” to advance to the live screen, see Chapter 6.3.

► Press “Yes” to continue saving the media information.

– or –

► Press “No” to permanently delete all case media (this will require con-

firmation). – or –

► Press “Cancel” to return to the case.

Selecting “Yes” will allow the patient’s information to be added or updated. Patient information saved prior to starting the case will be retained at the end of the case.

Fig.17

► Enter a first and last name, then press Next button to continue, or

Cancel button to return to the “Save Recorded Media?” message.

► Press the pencil button to add or update “Optional Patient Data”.

This option is enabled once a first and last name have been entered.

► Press OK button when done editing to proceed.

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 nonDICOM 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

After selecting to end the case:

Fig.16

Fig.18

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.

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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 confirmation once it completes.

Note

The location where case media will be saved is F:\TVS\TrueVision\Surgeons\<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 “Cancel” button (return to the application).

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 unpredictable 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.

Fig.20

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

The “Setup” panel in the home screen provides the following functions:

■ Move the robotic arm to a preset position

■ Rebalance the DSM

■ Enter recovery state

■ Reconfigure the coupler.

Note

Setup should always take place before surgery.

Fig.22

6.2.1 Preset positions

The available preset positions are:

■ Drape

■ Storage

6.2.2 Rebalance scope

Moving the robotic arm to its limits can affect the DSM’s balance. To correct the presence of any drift, the DSM can be rebalanced.

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 feels unbalanced during movement with the handle brake-release buttons.

► Ensure the area of the robotic arm is clear. ► Press “Rebalance Scope” in the “Setup” tab.

In rare instances, some configurations can cause the robotic arm to lock up when reaching the joint limits.

► If this occurs, move the robotic arm to a preset position.

Note

If proper rebalancing of the DSM still results in unsatisfactory balance, contact 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, robotic arm, recording, fluorescence, and access to settings.

a = 450 mm

b = 1 240 mm

Fig.23

Legend a Keep this area clear vertically during position change b Keep this area clear horizontally during position change

Risk of injury due to unintended movement of the robotic arm!

WARNING

► Select a pre-configured position for the robotic arm in the “Position”

drop-down list.

► Press the “Press and Hold to auto-position” button until the robotic

arm movement fully stops in position.

► Make sure the area surrounding the robotic arm

is clear of objects or people.

► Watch the robotic arm while it is moving.

Fig.24

6.3.1 Zoom, focus, and light controls

The “DSM” tab within the “DSM Control” panel shows controls for zoom, focus, white light levels, and DUV light levels (if licensed). The DSM control values can be adjusted by using the handles, footswitch, or the touchscreen.

► Press anywhere on the value bar or press and drag the slider to change

the values.

► Select the or buttons for fine tuning.

Setting Range

Zoom 1.00 × to 10.00 ×

Focus 200 mm to 450 mm

White Light 0 % to 100 %

DUV Light 0 % to 100 %

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6.4 Fluorescence controls

Note

Fluorescence module (DUV 400) requires a license for use with the DSM system.

DUV 400: The integrated DUV 400 fluorescence module of the DSM is used to visualize near-UV fluorescent areas in the surgical field. The module has been designed for excitation in the wavelength range from 390 nm to 420 nm and for fluorescence visualization in the wavelength range greater than 510 nm. The module enables the surgeon to switch between white light and blue-violet excitation light for 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 enabled. Use the touchscreen, handles, or footswitch to manually refocus the target image.

6.4.1 Function checks

The fluorescence reference card and the touchscreen are not sterile!

WARNING

► Before starting fluorescence visualization, always check the function-

ality of the integrated fluorescence module.

► Ensure that the DSM system is in a dark room, with no other illumina-

tion other than the DSM integrated lighting and the system displays.

► Place the reference card on a level surface. ► Set the focus to 325 mm and the zoom to 5 × on the touchscreen. ► Refocus the image by moving the DSM head upwards or downwards

using assisted drive.

► Activate the fluorescence function by selecting the “DUV 400 On” but-

ton on the touchscreen or the corresponding handle or footswitch button.

► In the live image, check the following:

– DUV 400: There is distinct contrast (orange/pink) between the DUV

400 reactive compound and the reference card (green/white).

– The reactive compound must be clearly distinguishable and the live

image should not be washed out. Slight deviations in color and brightness are acceptable.

6.4.2 DUV 400 imaging

The following factors influence the visualization of the fluorescence signal:

► Perform fluorescence functional tests before

surgery.

■ 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

■ Working distance and the illuminated field diameter

■ DSM white light level

► Activate the fluorescence function by selecting the “DUV 400 On” but-

ton on the touchscreen or the corresponding handle or footswitch button.

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.

6.5 Touchscreen robot control

Fig.25

The robotic arm pan and rotation movements can be controlled from the “Robot” tab in the “DSM Control” panel in precise, single-axis movements. Each arrow (Forward, Back, Left, Right, Up, and Down) corresponds to a directional movement in relation to the DSM head.

Holding down one of the directional arrow buttons moves the robotic arm until a joint limit is reached. Directional movements can also be employed by configuring the corresponding commands to the handle buttons (see Chapter 6.8.10) or footswitch buttons (see Chapter 6.8.11).

6.5.1 Lock On Target

The “Lock On Target” function locks the DSM onto a selected focal target in the live image. When enabled, directional movement will rotate around the focal target instead of moving linearly. Up and Down directional movement remains unchanged while “Lock On Target” is enabled.

“Lock On Target” does not apply when moving the DSM by using the handle brake-release buttons, even when enabled. After such a movement, Lock On Target movement will resume as long as it is enabled.

► Press the “Lock On Target” button to activate/deactivate the function.

6.5.2 Robot Speed

If the slider position is closer to “Min” (minimum), the robotic arm movement will be slower, and if the slider position is closer to “Max” (maximum), the robotic arm movement will be faster.

► Change the speed of the robotic arm movement by clicking anywhere

on the “Robot Speed” bar or by clicking and dragging the slider.

6.6 Quick Access Bar (QAB)

The Quick Access Bar (QAB) can be configured to show the top four mostused available functions in the home and live screens, as well as while in fullscreen.

Fig.26

► Edit the QAB by selecting the pencil button and toggling on or off

the available functions. Selected QAB functions are highlighted in green and are added to the

bar by order of selection.

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The following QAB functions are available:

Function Description

Viewport Configure the format for multiple inputs on screen.

Select between primary input, secondary input, split screen, or picture-in-picture. Configure a second video source in the input settings.

Swap Sources Switch between the primary and secondary input in the

main view.

Orientation Toggle the orientation of the primary input between

standard and inverted 180 degrees.

Digital Aperture

Autofocus Select to automatically focus the object in the center of

Toggle a digital aperture that blocks out the periphery of the image. Adjust the size and transparency in the “Digital Aperture” settings, see Chapter 6.8.3.

the DSM image.Start the autofocus by:

■ Pressing an appropriately configured handle button,

see Chapter 6.8.10

■ Pressing an appropriately configured footswitch

button, see Chapter 6.8.11

Note

If “Auto-focus After Move” in the “Camera” settings panel is disabled, the focal target will not be reassessed after manual movement while “Lock On Target” is enabled. To refocus image manually, use the touchscreen, handles, or footswitch.

6.7 Robotic arm state indicators

The robotic arm has defined force, speed, and geometric limits for safety. As the arm approaches a limit, the indicator shown in the lower right of the live screen will change its icon and color.

State Icon Description

Footswitch Directional Move with Restrictions

Handle Directional Move with No Restrictions

Handle Directional Move Approaching Restrictions

Free Drive State Displayed when robot arm is in “Free

Pre-Programmed Position Move

Assisted Drive Move with No Restrictions

Assisted Drive Move Approaching Restrictions

Assisted Drive Move with Restrictions

Uncalibrated State Displayed when arm hasn’t been cal-

Handle Directional Move with Restrictions

Displayed when moving the arm with the footswitch and arm reaches a directional limit

Displayed when moving the arm with the handle buttons and there are no movement restrictions

Displayed when moving the arm with the handle buttons and arm approaches directional limit

Drive State”

Displayed when arm is moving to a pre-programmed position

Displayed when moving the arm with the handles and there are no movement restrictions

Displayed when moving the arm with the handles and arm approaches directional limit

Displayed when moving the arm with the handles and arm reaches a directional limit

ibrated

Displayed when moving the arm with the handles buttons and arm reaches a directional limit

Specification Limit

Force 250 N

Speed 1 m/s

The Indicator states are pictured and described in the table below:

State Icon Description

Initializing State Displayed during initial power ON, or

when arm is initializing

Ready State Displayed when arm is ready for

movement

Emergency Stop State Displayed when Emergency Stop

button is engaged

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

tective stop state after the arm movement is interrupted

Soft Stop State Displayed when soft stop state is

selected

Footswitch Directional Move with No Restrictions

Footswitch Directional Move Approaching Restrictions

Displayed when moving the arm with the footswitch and there are no movement restrictions

Displayed when moving the arm with the footswitch and arm approaches a directional limit

GUI Directional Move with No Restrictions

GUI Directional Move Approaching Restrictions

GUI Directional Move with Restrictions

Failure State Displayed during a hardware mal-

Coupler in Unlocked Position

Note

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).

Displayed when moving the arm from the user interface and there are no movement restrictions

Displayed when moving the arm from the user interface and arm approaches a directional limit

Displayed when moving the arm from the user interface and arm reaches a directional limit

function

Displayed when coupler in Unlocked position and while changing coupler orientation

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 settings 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:

Icon Description

Exit panel without saving changes made to current panel.

Reset the current panel to its default settings. (Not present for DICOM or Input panels.)

Save changes and close panel.

6.8.1 Camera settings

In the Camera settings panel the following settings of the DSM camera can be modified:

■ Orientation

■ Auto-exposure

■ Auto-focus After Move

Orientation

The Orientation drop-down menu has the following options:

■ Standard (default, used for most configurations of the DSM head to

match the surgeon’s view)

■ Rotated (180° view from Standard orientation)

The orientation applies to all connected monitors, unless “Assistant” view is being used; see Chapter 6.8.7 for more information on “Assistant” view settings.

Note

The DSM handle button layout will rotate if the view is set to "Rotated" in software settings.

Auto-exposure

When “Auto-exposure” is enabled, the live view automatically adjusts for changing lighting conditions and is especially effective in reducing red color saturation.

When “Auto-exposure” is disabled, no adjustments to the live image will be made.

► Press the “Auto-exposure” toggle to disable (default) or enable the fea-

ture.

Auto-focus After Move

If “Auto-focus After Move” is enabled and the DSM is moved via any method, once the DSM stops movement the software will automatically refocus on the current focal point.

When this feature is disabled, manual adjustment to achieve ideal focus will be required (using the handles, footswitch, or touchscreen).

► Select the “Auto-focus After Move” toggle to enable (default) or dis-

able the feature.

6.8.2 Screen Layout

In the Screen Layout settings panel the following settings of the DSM camera can be modified:

■ Picture in Picture (PiP) Location

■ DSM Settings

Picture in Picture (PiP) Location

The “PiP Location” drop-down menu has the following options:

■ Bottom Right (default)

■ Top Left

■ Top Right

■ Bottom Left

DSM Settings

The “DSM Settings” drop-down list has the following options:

Option Description

Auto-Hide (default)

Show The DSM control values will always been shown on the

Hide The DSM control values will never be shown on the sur-

6.8.3 Digital Aperture

The Digital Aperture feature enables a digital overlay where the live image can be restricted to a circle in the center of the screen, with a dark mask covering the rest of the image.

► Press the toggle button to disable (default) or enable the feature.

Diameter

► Use the “Diameter” bar to select or slide the value anywhere between

0.05 (smallest diameter) and 1.00 (largest diameter). The default Diameter is 0.75.

Opacity

► Use the “Opacity” bar to select or slide the value anywhere between

0.05 (most transparent mask) and 1.00 (most opaque mask). The default Opacity is 0.50.

6.8.4 DUV 400 (Fluorescence)

In the DUV 400 panel the following settings for the DUV 400’s overlay can be modified:

The DSM control values (Zoom, Focus, and White Light) will be displayed over the live surgery screen for ~5 seconds and then hidden after adjusting the values.

surgery screen(s).

gery screen(s).

■ Hue: can be adjusted on a range of yellow to blue (default: green)

■ Opacity: can be adjusted from 0 to 100 (default: 100)

■ “Auto-Overlay”

“Auto-Overlay”, when enabled, transitions from DUV 400 to Overlay after a set amount of time. “Overlay Mode Timer” can be adjusted from 1 to 60 seconds. By default, “Auto-Overlay” is disabled and “Overlay Mode Timer” is set to 30 seconds.

6.8.5 Color

In the Color panel the following settings can be modified:

■ Gain: can be adjusted from 0 to 80 (default: 0)

■ Picture: adjust Brightness, Contrast, Gamma, Hue and Saturation

■ White Balance

Picture

Note

These are advanced settings. It is not recommended to change these settings.

► Select the desired quality setting by pressing or pressing and dragging

the slider on any of these settings: – Brightness: determines the intensity of the color in the live image

(range: 20 to 80, default: 48)

– Contrast: difference between the lightest and darkest regions of the

live image (range: 20 to 80, default: 55)

– Gamma: non-linear operation used to encode and decode lumi-

nance of the live image (range: 0.50 to 5.00, default: 1.20)

– 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 yellow (range: -180 to 180, default: 2)

– 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.

– 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 checkbox 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-configurations, 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.

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).

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 function of displaying the live image. “Surgery” view will display relevant notifications 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 touchscreen 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 available options:

– Monoscopic – Row-Interleaved – Side-by-Side – Top-Bottom –Dimenco

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Swap 3D

“Swap 3D” switches the left and right eye polarity and can be used to help determine if the monitor is using the correct 3D polarity setting.

► To check the polarity, close the right and left eye alternatively while

wearing 3D glasses and ensure the on-screen “Left” and “Right” text matches the eye opened.

6.8.8 Input Source

In the Input Source panel external display devices, such as an endoscope, can be configured to the correct input type.

The available input source types are:

■ SDI

■ HDMI

“Viewport 1" is set to the 3D live image from the DSM head.“Viewport 2" can be configured to display either SDI or HDMI input from connected external devices. Both SDI and HDMI devices can be connected simultaneously, however only one type can be displayed at a time.

► Press the corresponding radial button of the desired input type.

The following Aesculap camera systems are supported by the DSM:

Art. no. Supported settings

PV460 60 Hz signal, DVI output on PV460, SDI input on DSM

PV470 50 Hz signal, DVI output on PV470, HDMI input on DSM

PV480 50 Hz or 60 Hz signal, DVI output on PV480, HDMI or SDI

input on DSM

6.8.9 DICOM

Fig.27

In the DICOM panel the networking for uploading and downloading media to and from a configured server database can be set up.

Note

The DICOM module requires a license for use with the DSM system. See DICOM Conformance Statement TA015615-DCS for information

related to the use of DICOM data exchange.

■ Network and DICOM addresses must be provided by the IT administra-

tor responsible

■ AE titles are case-sensitive

■ A connection test is automatically run prior to each DICOM upload to

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”

and “PACS” tabs are editable and can be updated at any time.

Setting up network connection

► To set up the initial connection with the hospital network, consult with

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.

► Exit out of the DSM software onto the Windows Desktop, see

Chapter 5.11.

► Configure Ethernet connection using the Windows Control Panel.

6.8.10 Handles

In the Handles panel the layout and functions of the DSM head handles using can be customized.

► Press the “Left–Right” toggle to switch between handles. ► See below for a list and description of each button’s function.

Dual Mode

► Press the “Dual Mode” checkbox to enable/disable this function.

When Dual mode is enabled, both handles share the same configuration. Two Dual mode setups can be configured, A and B, and toggled between. The A–B toggle is only accessible when “Dual Mode” is enabled.

Available handle button functions

Button description Functionality

None No Function

Autofocus Microscope will automatically focus on the

center of the field of view.

Button Layout Map Displays the current button layout.

Cycle DUV 400 Toggle to a blue-light filter to intraoperatively

differentiate between diseased and healthy tissue after a 5-ALA injection.

DUV Light Down Reduce the amount of light while DUV 400

mode is on.

DUV Light Up Increase the amount of light while DUV 400

mode is on.

Digital Aperture Toggle

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

Waypoint Select/Move

Snapshot Take a snapshot.

Swap Sources Toggle between input sources. Can be config-

Lock-on Mode Toggle Toggle lock to target mode.

Viewport Layout Cycle

White Light (-) Decrease white light.

White Light (+) Increase white light.

Zoom (+) Increase zoom.

Zoom (-) Decrease zoom.

Toggle digital aperture overlay. Diameter and Opacity can be changed in settings.

configuration as a waypoint. Hold down button to delete selected waypoint.

Press button to toggle through saved waypoints. Hold down button to move to selected waypoint.

ured to either SDI or HDMI.

Cycle through available viewport settings. Can be configured to “Source 2”, “Picture in Picture”, or “Side by Side” view.

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6.8.11 Footswitch

In the Footswitch panel the footswitch can be paired with the DSM and the layout and function of the footswitch can be configured.

See below for a list and description of each button’s function.

Note

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

connection: – Do not press switches for at least 2.5 seconds. – Ensure that all LEDs on the footswitch are off.

► Simultaneously press and hold buttons 1 and 2 on footswitch until the

LED slowly blinks red, then select the Pair button in the DSM software.

The fooswitch is ready for pairing. The footswitch LED will blink red until a new dongle is found or until pairing mode times out after ~30 seconds.

► To stop the pairing process, press “Cancel”.

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.

A yellow status indicator means the footswitch is paired but inactive (no current command is being sent to the software).

A green status indicator means the footswitch is paired and in use (a current command is being sent to the software).

By pressing any of the control components the footswitch changes into 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 footswitch falls back to sleep mode. In this mode all indication LEDs are turned off.

Available footswitch button functions

The same button functions as for the handle are also available for the footswitch, see Chapter 6.8.10

6.8.12 About

In the About panel the following system information is shown:

■ Software version

■ Technical support contact information

■ Language selection

■ Link to the user manual

■ Other software and regulatory information

Language selection

► From the drop-down list, select the desired language, then select Save

button.

The DSM application will need to restart after changing the language.

► Select Cancel button to keep the current language.

Note

Patient data saved in a language other than the current language will not be displayed.

User manual

► Press “User Manual” to open the user manual folder found on the desk-

top.

► Double-click on the DSM user manual to open the PDF version.

Note

The DSM application does not need to be closed in order to view the user manual.

► Press “More” to open a separate panel with two pages.

Page 1 contains system information, including Computer Name, Mac Address, Camera, Licenses, and Software Part Number.

Page 2 contains regulatory information.

► Press Back button to return to the main “About” panel.

7. Reprocessing procedure

7.1 Single-use products

Art. no. Designation

PV012SU DSM sterile drape

Risk of infection for patients and/or users and impairment of product functionality due to reuse.

WARNING

7.2 Preparation before cleaning

► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth.

7.3 Limitations on reuse

The camera housing can be disinfected up to 140 times with the proper care. Any additional reprocessing falls under the responsibility of the user.

For the other parts of the DSM there is no set maximum number of uses and reprocessing cycles.

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 product.

A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

7.4 Cleaning/disinfection

7.4.1 Product-specific safety instructions for the reprocessing procedure

DANGER

CAUTION

Risk of injury, illness or death due to contamination and/or impaired functionality of the product!

► Do not reprocess the product.

Risk of electric shock and fire hazard!

► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or

disinfecting solutions.

► Ensure that no fluids will penetrate the product.

Damage to, or destruction of the product caused by mechanical cleaning/disinfection!

► Only clean and disinfect the product manually. ► Do not sterilize the product under any circum-

stances.

Damage to the product due to inappropriate cleaning/disinfecting agents!

► Only use cleaning/disinfecting agents approved

for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

Damage to the product due to inappropriate cleaning/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

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Phase Step T

[°C/°F]t[min]

I Cleaning RT - - - 55% isopropyl alcohol,

II Wipe disinfection RT ≥2 - - 55% isopropyl alcohol,

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

Phase I

► 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).

Conc. [%]

Water quality Chemical

0,25% n-alkyl dimethyl ethyl benzyl ammonium chloride, 0,25% n-alkyl dimethyl benzyl ammonium chloride*

7.8 Storage and transport

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

Colors look wrong Perform a white balance of the DSM head in the

software settings.

3D looks inverted Switch the 3D polarity in the software settings.

Image is upsidedown

Hard to see 3D Position the display so that it is directly in front

DSM head not detected

Light, zoom, or focus not working

Display not recognized

Spots on the display If the displayed image develops spots that do not

Robotic arm not working

Touchscreen not working

Rotate the DSM head orientation in the software settings.

of the surgeon. Some displays have a small ideal viewing angle. Adjust the height and tilt of the display for the best view.

If the software reports that the DSM head is not connected, check the DSM head cable connection at the EPU and at the DSM head. Unplug the cable connection at the DSM head and plug it back in to check if the software is operating correctly now. Ensure that the DSM head indicator is green.

Check that the DSM head power cable is connected. Ensure that the DSM head indicator is green. Restart the system. If issues remain, contact Aesculap Technical Service, see Chapter 10.

If a display is turned on after the EPU has started, it may not recognize the display. Check that the display cable is securely plugged into the back of the display. Restart the EPU.

move as the viewing target is moved, the DSM head optics may have dust on the viewing surfaces. Clean the optics and screen. If the spots remain, the dust may be inside the DSM head. Contact Aesculap Technical Service, see Chapter 10.

Reboot the system or follow the error messages shown on the display.

Re-connect the touchscreen.

9.2.1 Startup errors

Error message Remedy

Already initialized Restart the system.

DSM Head Manager failed

Cursor Manager failed

DSM failed

Event Manager failed

Message System failed

Core functions failed

Patient Manager failed

Playback Manager failed

Procedure Manager failed

Recording Manager failed

Storage Manager failed

Surgeon Manager failed

QAB settings failed

Video Capture Manager failed

Widget Manager failed

Invalid init parameters

Failed to run

9.2.2 License error

Error message Remedy

DSM license not found. Please contact Aesculap for support.

9.2.3 Recording errors

Error message Remedy

Recording failed. Not enough disk space available.

Erasing recordings less than [3] seconds.

Insufficient space on external drive. Internal drive has approx. [time] remaining.

If that does not help, contact the local Aesculap representative or Aesculap Technical Service, see Chapter 10.

Contact the local Aesculap representative or Aesculap Technical Service, see Chapter 10.

Download any videos from the system that should be kept and delete any extra files to free up space on the computer.

Any recordings shorter than three seconds are automatically deleted. Create a longer recording.

Download any videos from the system that should be kept and delete any extra files to free up space on the connected drive. Recordings will only save locally.

[Drive volume name] drive connected. Insufficient recording space.

Download any videos from the system that should be kept and delete any extra files to free up space on the connected drive.

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9.2.4 DSM head errors

Error message Remedy

DSM head is too hot. Maximum white light reduced to 50%.

Connect DSM head. The system is not connected to the DSM

Possible image degradation detected.

The DSM head is overheating. The maximum white light setting has been capped at 50%. Turn the system off and allow it to cool when safe.

head. Connect the DSM head while the system is off. Wait 30 seconds and restart. If the connection is failing, contact Aesculap Technical Service, see Chapter 10.

Frame rate from the DSM head is not acceptable. Check DSM head cable connections. Contact Aesculap Technical Service, see Chapter 10.

10. Technical Service

Risk of death for patient and operator due to malfunction and/or failure of safety measures!

WARNING

CAUTION

Service addresses

Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1601 Fax: +49 (7461) 16-2887 E-Mail: ats@aesculap.de Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

► Do not perform any service or maintenance

while using the product on the patient.

► Do not modify the product.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses!

► For service and repair, contact the local

B. Braun/Aesculap representative.

11. Technical data

11.1 Performance data, information about standards

Weight (unpacked) 454 lbs. / 206 kg

Weight (in crate)

Dimensions (unpacked, L × W × H)

Dimensions (in crate, L × W × H)

Power input

EMC

Conforming to standard IEC/DIN EN 60601-1

600 lbs. / 272 kg

32.5” × 48.3” × 76.3” / 826 mm × 1 227 mm × 1 938 mm

39.7” × 48” × 71.6” / 1 008 mm × 1 219 mm × 1 819 mm

100/120/240 V AC, 850 W, 50 Hz / 60 Hz

IEC/DIN EN 60601-1-2

11.2 Ambient conditions

Operation Storage and transport

Temperature 10°C to 35°C -10°C to 50°C

Relative humidity

Atmospheric pressure

30 % to 90 % non-condensing

700 hPa to 1 060 hPa 500 hPa to 1 060 hPa

10 % to 90 % non-condensing

12. Disposal

Note

The user institution is obliged to process the product before its disposal, see Chapter 7.

Adhere to national regulations when disposing of or recycling the product, its components and its packaging! The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service.

► Detailed information concerning the disposal of the product is avail-

able through the national B. Braun/Aesculap agency, see Chapter 10.

13. Distributor in the US/Contact in Canada for product information and complaints

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

Aesculap

– a B. Braun brand

SOP-AIC-5001887 (TA015615) 2019-02

B. Braun Aesculap DSM Instructions For Use/technical Description

Specifications and Main Features

Frequently Asked Questions

User Manual