
2. Information
2.1. Safety-related information
Observe the instruction manual
:
Every use of the device requires exact knowledge
and observance of this instruction manual. The
device is only intended for the use described herein.
Patient instruction
:
Patient instruction must only be carried out by the
doctor or staff authorized by that person. The
enclosed quick reference cannot take the place of
the
manuals
instructions
and
warnings
about
possible hazards.
Do not open the device!
Warning:
For online measuring you must use an electrical or
optical isolator for connection of the device to the PC
(available from your home care provider). A connec-
tion of the device to the PC without electrical or
optical isolator is only allowed if all patient connec-
tions have been removed first. Only Physicians or
trained staff is allowed to perform online measure-
ments.
Warning:
Magnetic and electrical fields can impact on the func-
tioning of the device. When operating the device, en-
sure that all third-party devices being operated in the
vicinity are meeting their relevant EMC requirements.
X-Ray equipment, HF surgical devices, tomography
devices etc. can interfere with other devices as they
may emit higher levels of electromagnetic interfe-
rence.
Warning:
The device has no defibrillator protected application
parts. A direct application of the device to the heart
(esp. ECG!) is not allowed.
Warning:
Using multiple devices for patient screening could re-
sult in excessive leakage current above the allowed
value!
Warning:
Using the device together with active implants as
pacemakers, peripheral nerve stimulation devices,
tongue pacemaker etc. can result in disturbances of
the active implant or the device.
Warning:
Applying the device to more than one patient at any
one time is not allowed.
Warning
:
When applying sensors to the patient, please ensure
that no electrical line of the device is in contact with
any
other
electrical
conductive
parts
including
ground.
Warning
:
Avoid placing this instrument in direct sunlight or in
close proximity to intense heat. Prevent also the
contact with dust, lint, dirt, moisture and liquids.
Warning
:
Children or incompetent persons should not use this
device unattended without first having obtained ins-
tructions for the safe use of the device. Ensure that
infants, children and animals cannot touch the device
unattended
2.2. General information
This instruction manual should be regarded as a
component of the device. It should be kept on hand
somewhere near the device at all times. Reading and
understanding the instruction manual is a prerequi-
site for proper use and correct handling of the device
in order to maintain the safety of the patient and
operator.
The guarantee is valid for a period of 24 months for
the device and 6 months for the equipment from the
date of sale.
Only accessories which are listed in this instruction
manual should be used with the device. We cannot
guarantee the safe operation and function of the
device if unknown proprietary accessories / consum-
ables are used that have not been tested. (E.g.
Patient leads, Sensors, Consumables, Memory
cards etc.)
Damages resulting from the use of third-party
accessories or consumables shall render this
warranty void.
The manufacturer will only assume responsibility for
the device in terms of safety, reliability and function
if:
1. assembly, add-ons, reinstallation, changes
and repairs are carried out by the manufac-
turer or a qualified agent authorized by the
manufacturer to do so;
2. The device is used in accordance with the
instruction manual.
All printed material relates to the model of the device
and the safety regulations at the time of printing. All
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