60 78 104 D 3488
4
D 3488.201.01.07.02
11.2009
1 Warning and safety information
Operating Instructions SIROEndo
1
Warning and safety information
1.1
General safety information
Retention of documentation
It is very important to make sure that this manual is stored together with the
unit so that it will also be available at any time in the future. In case the unit is
sold or the right to use it is transferred to a different owner, make sure that the
manual always remains located near the unit. This is necessary to ensure that
the new owner can use the unit properly and has all required information.
Read carefully before starting!
These instructions serve to promote safety. Be sure to read them carefully
before installing and using the unit.
This symbol appears on the rating plate to remind the user to observe the
manual.
Medical electrical devices may be used only with reference to the risk of elec-
trical shock, fire or mechanical hazards according to IEC 60601-1.
WARNING!
There is a risk for patients with cardiac pacemakers that the pacemaker
can be disturbed during treatment with the SIROEndo unit. We recom-
mend not using the SIROEndo for these patients.
Intended use
SIROEndo
is an electrical digital control system for endodontics. It may be
used only by qualified dental personnel.
Disclaimer
The manufacturer assumes no liability whatsoever in cases involving:
z
work or repairs performed by any personnel not authorized by the manu-
facturer or importer.
z
an application which does not correspond to the ones described in this
manual.
z
the use of non-OEM components or any components not described in the
section entitled
Parts list
.
z
clinical use of this unit, especially in cases involving possible breakage of
the respective file in the root canal.
Electromagnetic compatibility
In order to prevent possible risks caused by electromagnetic interference, no
medical electrical or other equipment should be used near the SIROEndo.
The unit complies with the currently valid directives concerning electromag-
netic compatibility
(IEC 60601-1-2).
Only medical devices which comply with the IEC 60601-1 standard may be
connected to the SIROEndo. Any non-medical devices connected also must
comply with the IEC 60601-1-1 standard for medical devices.
¾
This unit does not cause any harmful interferences. It can, however, pick
up interferences from other devices, including interferences which cause
undesirable operation.
Operating environment
Never use this unit in the presence of flammable anesthetics or anesthetic
agents mixed with air, oxygen or nitrogen.
Inspection and maintenance
No preventive inspections or maintenance are required.
Connected devices
SIROEndo is supplied without endo files and without contra-angle hand-
pieces.
The SIROEndo can accommodate any contra-angle handpiece with an ISO
standard coupling that complies with the ISO 3964 standard.
When using files, please comply with the manufacturer's instructions.
