Wireless Footswitch; Danger; Scope Of Use; Intended Use - B. Braun Aesculap OrthoPilot Elite FS112 Gebrauchsanweisung/Technische Beschreibung

en
1.

Scope of Use

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For item-specific instructions for use and information electromagnetic
compatibility (EMC) and material compatibility see also the Aesculap
Extranet at https://extranet.bbraun.com
2.

Intended use

2.1

System description

® Elite
The OrthoPilot Hardware System is a navigation system and supports
the physician in joint surgeries, such as for individual patient positioning
of implants in the area of endoprosthetics. Using a video optical camera
system, the position and location in space of passive transmitters reflect-
ing infrared light are detected intraoperatively.
Using Aesculap-specific application software installed on the OrthoPilot
computing and display unit, the location and position of the transmitters
relative to each other can then be calculated. Through adaptation of the
transmitters to the instruments and patient, the location and position of
the instruments in relation to the patient can also be displayed.
By using this software, the measured values are calculated together with
additional data (e.g. implant geometries), supporting the user in aligning
and positioning the implant. In addition, the individual implant compo-
nents can be matched to one another in order to achieve optimized results
with regard to important criteria of the implantation
® Elite
The OrthoPilot Hardware System is a system that does not use expen-
sive and radiation-intensive image data, such as from CT or MRI.
It is a closed system; that is, it may only be used with application-specific
software, instrumentation and implant systems approved by Aesculap.
® Elite
The OrthoPilot Hardware System consists of the following compo-
nents:
Art. no. Designation
FS110 ®

OrthoPilot

4 stand
FS111 ®

OrthoPilot

4 wireless camera
FS112 ®
OrthoPilot 4 panel PC
FS113 ®
OrthoPilot

4 wireless footswitch

Optional:
FS082 ®
OrthoPilot 4 complete reusable transport box
The duration of use of the system depends on the indication and is nomi-
nally about 60 minutes.
The system components of the OrthoPilot
invasive, reusable products for use in non-sterile surgery areas.
Function/task of the OrthoPilot
®
The OrthoPilot 4 panel PC serves for the provision, execution, data pro-
cessing, data storage and display of the Aesculap-specific application
software and the data generated there as a foundation to enable com-
puter-supported, orthopedic surgery.
4
® Elite
Hardware System are non-
®
4 panel PC in the system
2.2

Indications

® Elite
The OrthoPilot Hardware System can be used for the following indi-
cations:
■
Bicondylar knee endoprosthesis (TKA), unicondylar knee endoprosthesis
(UKA) and for knee revision interventions (TKR) in conjunction with
approved Aesculap-implants
■
Hip endoprosthesis (THA) for various accesses (conventional or less
invasive techniques) in conjunction with approved Aesculap-implants
■
Corrective osteotomies
Note
The manufacturer is not responsible for any use of the product against the
specified indications and/or the described applications.
®
2.3

Contraindications

2.3.1

Absolute contraindications

Corresponding contraindications result from the specific medical applica-
tions or from the implants used; see corresponding usage instructions.
2.3.2

Relative contraindications

■
The following medical or surgical conditions (such as comorbidities)
can lead to delayed healing or compromise the success of the opera-
tion.
■
The clinically successful use of the product depends on the knowledge
and experience of the surgeon, whose responsibility it is to decide, in
consideration of the safety and warning notices in the usage instruc-
tions, whether the product can be used successfully.
■
Additional corresponding contraindications result from the specific
medical applications or from the implants used (see corresponding
usage instructions).
3.

Safe handling

CAUTION
Federal law restricts this device to sale by or on order of a physician!
Risk of death by electric shock!
►
Do not open the product.

DANGER

►
Connect the product only to a grounded power
supply.
►
Do not touch the device and patient at the same
time.
Risk of injury caused by incorrect operation of the
product!
►
Attend appropriate product training before
WARNING
using the product.
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For information about product training, please
contact your national B. Braun/Aesculap agency
Damage to the product from condensation water!
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Before commissioning the OrthoPilot
CAUTION
PC, let it acclimatize until there is no more con-
densation on the outer surfaces.
®
4 panel