General Information - SCHILLER MEDICAL SAS FRED easy User Manual

General Information

®
•
FRED easy bears the CE mark
CE-0459
indicating its compliance with the provisions
of the Council Directive 93/42/EEC about
medical devices and fulfills the essential re-
quirements of Annex I of this directive. FRED
easy® is a class IIb device.
•
The product complies with the electromag-
netic immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 "Electromagnetic
Compatibility - Medical Electrical Equipment".
•
The radio interference emitted by this device
is within the limits specified in the CISPR 11
standard.
•
The user guide is an integral part of the
device and should always be kept near the
device. Close observance of the information
given in the user guide is a prerequisite for
using the device as intended for and correct
operation and ensures patient and operator
safety. Therefore, be sure to read the
complete user guide.
•
To ensure patient safety, the specified meas-
uring accuracy, and interference-free opera-
tion, we recommend to use only original
SCHILLER accessories. The user is respon-
sible if accessories from other manufacturers
are used. The warranty does not cover dam-
age resulting from the use of unsuitable ac-
cessories and consumables from other
manufacturers.
•
SCHILLER is responsible for the effects on
safety, reliability, and performance of the de-
vice, only if
− assembly operations, extensions, read-
justments, modifications, or repairs are
carried out by SCHILLER or by persons
authorized by SCHILLER
− the device is used in accordance with the
instructions given in this manual.
•
The customer is responsible, if the device is
employed in a manner different from the
method described in this manual.
•
On request SCHILLER will provide a detailed
field service manual.
•
The manufacturer is only liable for
SCHILLER-supplied accessories.
4
General Information
•
The user guide informs the device operator
about the intended use, exact function, op-
eration and required preventive maintenance.
It is not a substitute for a product training.
•
The safety information given in this manual is
classified as follows:
indicates an imminent hazard. If not
avoided, the hazard will result in death or
serious injury.
indicates a hazard. If not avoided, the
hazard can result in death or serious in-
jury.
indicates a potential hazard. If not
avoided, this hazard may result in minor
personal injury or product/property dam-
age.
•
This manual conforms with the device speci-
fications and safety standards valid at the
time of printing. All rights are reserved for de-
vices, circuits, techniques, software pro-
grams, and names appearing in this manual.
•
The SCHILLER quality management system
complies with the international standards ISO
9001 and ISO 13458.
•
No part of this manual may be reproduced
without written permission from SCHILLER.
Manufacturer
SCHILLER MEDICAL SAS
4, Rue Louis Pasteur
F-67162 Wissembourg – Cedex, France
Telephone **33 (0) 3 88 63 36 00
FAX **33 (0) 3 88 94 12 82
E-mail info@schiller.fr
FRED easy®
Danger
Warning
Caution