4
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 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!
►
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.
►
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.
DANGER
Risk of fatal injury from electric shock!
►
Do not open the product.
►
Connect the product only to a grounded power
supply.
Summary of Contents for Aesculap DSM
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