6
USA
1.
About this document
Note
General risk factors associated with surgical procedures are not described
in these instructions for use.
►
Article-specific instructions for use and material compatibility infor-
mation can be obtained by visiting our website at www.aesculapusa-
ifus.com
1.1
Scope
This document describes all necessary instructions and steps for the pro-
vision, setting and safe operation of the ELAN 4 electro system and its
accessory components.
Additional instructions and steps regarding the accessory components, in
particular on their connection and reprocessing, can be found in the
respective instructions for use or supplement for the components.
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 not prevented, minor or moderate inju-
ries may result.
CAUTION
Indicates a potential damage to property. If not prevented, the pro-
duct may be damaged.
2.
General information
2.1
Intended use
The ELAN 4 electro control unit GA800 together with the accessory forms
an electrically operated motor system.
The ELAN 4 electro control unit GA800 supplies the energy and monitors
the motors in the ELAN 4 electro applied parts. The control unit receives
the speed request via the hand or foot control. The direction of rotation is
preselected by means of the foot control buttons, by means of the display
when using a hand control and by means of the pushers for the drill tool.
The purpose of the integrated coolant and irrigation pump is to deliver
coolant or irrigation fluid to the operating field for cooling the tool and
tissue or irrigating the operating field. It is activated via the buttons on the
foot control or via the display.
2.2
Application Environment
The motor system fulfills the requirements of Type BF in accordance with
IEC/DIN EN 60601-1.
For use in operating rooms, outside of the explosive hazard zone (e.g. areas
with highly pure oxygen or anesthetic gases).
2.3
Indications
The ELAN 4 Electro Motor System is intended for high speed cutting, saw-
ing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofa-
cial Surgery.
2.4
Contraindications
The ELAN 4 electro motor system is not authorized for use in the central
nervous system or central circulatory system.
Note
The safe and effective use of electrically driven applied parts depends heav-
ily on influences that only the user can control him or herself. Therefore the
specifications provided represent framework conditions only.
Note
The clinical success of the use of the ELAN 4 electro motor system is depen-
dent on the knowledge and experience of the surgeon. The surgeon must
decide which structures it is sensible to treat and take into account the
safety and warning information contained in these instructions for use.
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
WARNING
Risk of injury and material damage due to inappropriate use of the
product!
►
Use the product only in accordance with the intended use.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
The ELAN 4 electro control unit GA800 together with the accessory
forms an electronically operated motor system.
►
Follow the instructions for use of ELAN 4 electro accessories.
►
Follow the instructions for use of all products used.
■
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.
■
The ELAN 4 electro control unit GA800 fulfills the requirements of
CISPR11, Class A.
►
Inspect the new product after removing its transport packaging and
prior to first use to ensure it is in good working order.
►
Observe “Notes on Electromagnetic Compatibility (EMC) for
ELAN 4 electro control unit GA800“ TA022452 , see Instructions for Use
at www.aesculapusaifus.com
►
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.
Maximum delivery rate of the pump
65 ml/min
Control unit
Application Environment
In the unsterile area
Set-up location
Table, ceiling supply unit, equipment cart,
or similar
Document No.: IFU - Version: 3.0 - Document ID: SOP-AIC-5001568 Date/Time Printed/Viewed: 2022-04-13 15:59 (CET)
Effective