General Information
4
Marquette Responder® 3000
227 490 02-C
General Information
The product Marquette Responder
®
3000 bears
the CE marking
CE-366
indicating its compliance with the provisions
of the Council Directive 93/42/EEC about
medical devices and fulfills the essential re-
quirements of Annex 1 of this directive.
The product complies with the electromagnetic
immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 "Electromagnetic
Compatibility - Medical Electrical Equip-
ment".
The radio-interference emitted by this device
is within the limits specified in CISPR11/EN
55011, class A.
The device is designed to comply with IEC 60601
requirements. It is a protection class I device
and has an internal power source. It is classi-
fied as an MDD class IIb device.
The CE mark covers only the accessories
listed in the "Order Information" chapter .
This manual reflects software version 2.
This manual is an integral part of the device. It
should always be kept near the device. Close
observance of the information given in the
manual is a prerequisite for proper device
performance and correct operation and ensures
patient and operator safety. Please note that
information pertinent to several chapters is
given only once. Therefore, carefully read
the manual once in its entirety.
The symbol
means: Consult accompany-
ing documents. It indicates points which are of
particular importance in the operation of the
device.
This manual is in conformity with the device
specifications and standards on safety of elec-
tromedical equipment valid at the time of
printing. All rights are reserved for devices,
circuits, techniques, software programs, and
names appearing in this manual.
On request Marquette Hellige will provide a
service manual.
The Marquette Hellige quality management
system complies with the standards DIN EN
ISO 9001 and EN 46001.
The safety information given in this manual is
classified as follows:
Danger
indicates an imminent hazard. If not avoided, the
hazard will result in death or serious injury.
Warning
indicates a hazard. If not avoided, the hazard can
result in death or serious injury.
Caution
indicates a potential hazard. If not avoided, this
hazard may result in minor personal injury and/or
product/property damage.
To ensure patient safety, the specified
measuring accuracy, and interference-free
operation, we recommend to use only original
Marquette Hellige components. The user is
responsible for application of accessories from
other manufacturers.
The warranty does not cover damage resulting
from the use of unsuitable accessories and
consumables from other manufacturers.
Marquette Hellige is responsible for the effects
on safety, reliability, and performance of the
device, only if
−
assembly operations, extensions, readjust-
ments, modifications, or repairs are carried
out by Marquette Hellige or by persons
authorized by Marquette Hellige,
−
the device is used in accordance with the
instructions given in this operator's manual.
Marquette Hellige GmbH 2000
Postfach 600265
79032 Freiburg, Germany
Tel49 761 45 43-0
Содержание Marquette Responder 3000
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