Safe Handling; Product Description; Scope Of Supply; Components Required To Operate The Device - Braun Aesculap OrthoPilot Elite OrthoPilot 4 FS112 Instrucciones De Manejo

3.

Safe handling

CAUTION
Federal law restricts this device to sale by or on order of a physician!
DANGER
Risk of death by electric shock!
►
Do not open the product.
►
Connect the product only to a grounded power supply.
►
Do not touch the device and patient at the same time.
WARNING
Risk of injury caused by incorrect operation of the product!
►
Attend appropriate product training before using the product.
►
For information about product training, please contact your
national B. Braun/Aesculap agency
CAUTION
Damage to the product from condensation water!
►
Before commissioning the OrthoPilot
until there is no more condensation on the outer surfaces.
■
General risk factors associated with surgical procedures are not
described in this documentation.
■
It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■
The operating surgeon must have a thorough understanding of both the
hands-on and conceptual aspects of the established operating tech-
niques.
■
In case of failure of the OrthoPilot
ing the continued use of the OrthoPilot
must be able to finish the operation using manual techniques.
►
Disinfect the new product by wiping after removing its transport pack-
aging.
►
Prior to use, check that the product is in good working order.
►
To prevent damage caused by improper setup or operation, and to not
compromise the manufacturer warranty and liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
– Operate the product only with the software approved by the manu-
facturer.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►
Always adhere to applicable standards.
►
The following instructions for use must be observed and kept accessible
for the user:
– Instructions for use of the OrthoPilot
FS112 and FS113)
– Instructions for use of the implants and instruments used in the
respective operation
– Instructions for use of the passive rigid bodies (transmitters)
– Instructions for use and manuals for the respective software appli-
cations
– Notes on the electromagnetic compatibility (EMC) for the
® Elite
OrthoPilot system TA015711
►
Do not operate the product in an oxygen-enriched environment or in
the presence of flammable substances (e.g. benzene, anesthetics).
►
Do not place containers filled with liquids on the device. Liquids pene-
trating into the device can damage the electrical components.
►
Do not connect multiple sockets/extension cords to the OrthoPilot
Hardware System.
®
4 panel PC, let it acclimatize
®
4 or any other malfunction preclud-
® Elite
Hardware System, the user
®
4 components (FS110, FS111,
►
Only pull cables on the plug.
►
Follow the safety information and maintenance instructions on the
product.
Note
The user agrees to report all serious incidents occurring in connection with
the product to the manufacturer and to the competent authority of the
country in which the user is registered.
4.

Product description

4.1

Scope of Supply

Art. no. Designation
FS112
OrthoPilot
FS112802
OrthoPilot
TA014963 Instructions for use of the OrthoPilot
4.2

Components required to operate the device

Art. no. Designation
FS110 OrthoPilot
– or –
FS112830 Power supply for the OrthoPilot
For operation with the external power supply, one of the
following power cables:
FS095 Angled power cable, Switzerland
FS096 Angled power cable, Euro plug
FS097 Angled power cable, UK and Ireland
FS098 Angled power cable, Japan/USA/Canada
FS099 Angled power cable, Brazil
Additional USB security keys are required for operation
for data protection reasons:
FS112802 OrthoPilot
4.3

Operating principle

®
The OrthoPilot 4 panel PC forms the central computing and display unit
® Elite
of the OrthoPilot
tons with which the system can be switched on and the brightness and
volume can be individually adjusted.
After switching on using the ON button 1, the OrthoPilot
screen 6 is loaded. This forms the central starting mask, to start the appli-
cation processes, adjust settings and administer the peripheral devices, see
Chapter 7.. Entries are made using the touch screen. A virtual keyboard is
faded in for keyboard entries.
The power supply of the OrthoPilot
®
OrthoPilot 4 stand FS110 or via the tabletop power supply FS112830
specially approved for the OrthoPilot
4.3.1 OrthoPilot
®
The OrthoPilot 4 wireless footswitch serves the OrthoPilot
System as a remote control option for the Aesculap-specific application
software.
®
The OrthoPilot 4 foot switch wireless is powered by an integrated battery.
®
The OrthoPilot 4 wireless footswitch has a large main pedal and two
small side pedals with which various commands are carried out through
short or longer depression.
Additional information on the OrthoPilot
described in the information for use TA014933.
® Elite
®
4 Panel PC
®
USB security keys
®
4 stand
®
4 panel PC
®
USB security keys
Hardware System. It has hardware operating but-
®
4 panel PC is either via the
®
4 panel PC.
®
4 wireless footswitch
®
4 wireless footswitch is
en
®
4 panel PC
®
4 home
® Elite
Hardware
5