Instruction Manual
DIAMENTOR E
- 2 -
Security Information
[D151.131.0/3]
Security Information
•
The instruction manual is an integral part of the
device. It should always be kept near the device.
Observance of the manual is a prerequisite for
proper device performance and correct
operation.
•
Operator safety, specified measuring accuracy
and interference-free operation can be
guaranteed only if original devices 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 device, or
else accessories whose use has been expressly
permitted by PTW-Freiburg. Safe operation and
proper device performance are not guaranteed if
accessories or consumables from other
manufacturers are used.
•
PTW-Freiburg cannot be held liable for damages
resulting from the use of accessories or
consumables from other manufacturers.
•
The warranty period is 1 (one) year and begins
on the day of delivery.
It is unaffected by repairs covered by the
warranty regulations.
•
Devices on which moisture has developed as a
result of temperature changes may not be
switched on unless completely dry.'
•
PTW- Freiburg considers itself responsible for
safety, reliability and performance of the device
only, if assembly, extension, readjustment,
modifi-cation or repair is carried out by PTW-
Freiburg or by persons authorized by PTW-
Freiburg,and if the device is used in compliance
with the technical documentation.
•
This technical documentation is in conformity
with the device specifications and all applicable
safety standards valid at printing date. All
rights are reserved for devices, circuits,
techniques and names appearing in the manual.
•
No part of the technical documentation may be
reproduced without written permission from
PTW-Freiburg.
CE-Marking
•
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 1 of this
directive. The product is a class IIb device
(MDD).
Electromagnetic immunity
•
The product fully complies with the
electromagnetic immunity requirements of
standard EN 60601-1-2 `Electromagnetic
Compatibility - Medical Electrical Equipment`.
Safety Instructions
•
Dispose the packaging material according the
applicable waste disposal regulations and keep it
out of children's reach.
•
The product is a medical device. Only person
with sufficient knowledge and skill may use the
device.
•
Before using the device, the operator must
ascertain that it is in correct working order and
operating condition.
•
The operator must be trained in the use of the de-
vice.
•
Set up the device so that the operator has a clear
and unobstructed view of the control panel.
•
The product is not suitable for operation in
areas of risk where an
explosion hazard
may
occur. Explosion hazards may be caused by the
use of combustible anesthetics, skin-cleansing
agents and disinfectants. Furthermore the
device is of restricted suitability for application
in
oxygen-enriched atmospheres.
The
atmosphere is considered to be oxygenenriched
when more than 25% of oxygen or nitrous oxide
is added to the ambient air.
•
Set up the device in a location which affords
sufficient ventilation. The air gaps of the device
must not be obstructed. Always observe the
ambient conditions as indicated in the `Technical
Specifications`.
