Wireless Footswitch; About This Document; Scope Of Use; Warnings - Braun Aesculap OrthoPilot Elite OrthoPilot 4 FS112 Instrucciones De Manejo

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1.

About this document

Note
General risks of surgical interventions are not described in these instruc-
tions for use.
1.1

Scope of Use

These instructions for use apply to the product listed below:
Art. no. Designation
®
FS112

OrthoPilot

4 panel PC
►
For article specific instructions for use and material compatibility, see
B. Braun eIFU at eifu.bbraun.com
1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may
occur during the use of the product. Warnings are marked as follows:
DANGER
Indicates a potential danger. If it is not prevented, death or severe
injuries may result.
WARNING
Indicates a potential danger. If it is not prevented, minor or moderate
injuries may result.
CAUTION
Indicates a potential damage to property. If these are not prevented,
the product may be damaged.
2.

General information

2.1

System description

® Elite
The OrthoPilot Hardware System is a navigation system the physician
can use for support in surgical interventions in joints, e.g. for patient-spe-
cific positioning of implants in joint reconstruction and replacement.
Using a video optical camera system, the position and location of passive
transmitters reflecting infrared light are detected intraoperatively in 3
dimensions.
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.
4
® Elite
The OrthoPilot Hardware System consists of the following compo-
nents:
Art. no. Designation
FS110

OrthoPilot

FS111
OrthoPilot
FS112
OrthoPilot
FS113
OrthoPilot
Optional:
FS082
OrthoPilot
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.
2.2

Intended purpose

®
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.
2.3

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.
2.4

Contraindications

®
2.4.1

Absolute contraindications

Corresponding contraindications result from the specific medical applica-
tions or from the implants used; see corresponding usage instructions.
2.4.2

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).
®
4 stand
®
4 wireless camera
®
4 panel PC
®

4 wireless footswitch

®
4 complete reusable transport box
® Elite
Hardware System are non-