DIAMENTOR E2
General Information
2
D651.131.00/05 en
General Information
− The product bears the CE-mark "CE-0124" in
accordance with the Council Directive
93/42/EEC about Medical Devices and fulfills
the essential requirements of Annex I of this di-
rective. The product is a class IIb device
(MDD).
− Furthermore, the DIAMENTOR E2 helps fulfill
the requirements of the EC patient directive
97/43/EURATOM regarding the acquisition and
documentation of the radiation exposure of pa-
tients during X-ray examinations.
− Product standard
The product fully complies with the require-
ments of the following standards:
IEC 60580
− Electrical safety
The product fully complies with the require-
ments of the following standards:
IEC 60601-1
ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1
− Electromagnetic immunity
The product fully complies with the require-
ments of the following standards:
IEC 60601-1-2
IEC/CISPR 11 class B
− The user manual is an integral part of the prod-
uct. It should always be kept near the product.
Observance of the manual is a prerequisite for
proper product performance and correct opera-
tion.
− Operator safety, specified measuring accuracy
and interference-free operation can be guaran-
teed only if original products and parts are
used. Furthermore only the accessories listed in
this manual are approved by PTW-Freiburg and
may be used in conjunction with the product, or
else accessories whose use has been ex-
pressly permitted by PTW-Freiburg. Safe op-
eration and proper product performance are not
guaranteed if accessories or consumables from
other manufacturers are used.
− PTW-Freiburg cannot be held liable for dam-
ages resulting from the use of accessories,
consumables from other manufacturers or when
the user ignores the instructions and informa-
tion given in this manual.
− The warranty period is 1 (one) year and begins
on the day of delivery.
It is unaffected by repairs covered by the war-
ranty regulations.
− PTW-Freiburg considers itself responsible for
safety, reliability and performance of the prod-
uct only, if assembly, extension, readjustment,
modification or repair is carried out by
PTW-Freiburg or by persons authorized by
PTW-Freiburg, and if the product is used in
compliance with the technical documentation.
− In case of any questions concerning service,
support or warranty please contact your sup-
plier.
− This manual is in conformity with the product
specifications and all applicable safety stan-
dards valid at printing date. All rights are re-
served for devices, circuits, techniques, soft-
ware and names referred to in the manual.
− PTW-Freiburg reserves the right to make modi-
fications.
Please contact PTW or your local representa-
tive for the most current information concerning
the products of interest.
− No part of the technical documentation may be
reproduced without written permission from
PTW-Freiburg.
− PTW-Freiburg is registered manufacturer ac-
cording to the ElektroG (Elektro- und Elek-
tronikgeräte-Gesetz).
Elektro-Altgeräte-Register (EAR) Registration
number DE15599992.
To Next Page
Loading...
