2. Information
2.1. Safety-related informations
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.
No alarm function available!
The device is not suitable for continuous monitoring
of vital or physiological functions (for example,
intensive monitoring, monitoring operation) since
there is no SpO2 alarm. No direct data analysis takes
place in the device.
No SIDS Monitoring
:
The device is not suitable for use as a SIDS monitor
(SIDS: Sudden Infants Death Syndrome, sudden
child death).
Patient instruction
:
Patient instruction must be provided by a healthcare
professional trained in the device. An attached short
manual does not replace the manual instructions or
the warning of possible hazards.
Separation from the supply network:
:
To isolate the device from the supply network, the
plug of the power supply must be disconnected.
Do not open the device!
Warning:
Additional devices that are connected to medical
electrical (ME) devices must be able to meet their
IEC or ISO standards. Anyone connecting additional
devices to ME devices is a system configurator and
is responsible for the ME system being in compliance
with the normative requirements (for example, IEC
60601-1).
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. Use of this equipment adjacent
to or stacked with other equipment should be
avoided because it could result in improper ope-
ration. If such use is necessary, this equipment and
the other equipment should be observed to verify that
they are operating normally. When operating the
device, ensure 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 interference.
Warnung:
The device has no defibrillator protected application
parts! Disconnect the device before defibrillation! A
direct application of the device to the heart (esp.
ECG!) is not allowed!
While the device is being worn, no invasive or
intracorporal measurements and interventions (e.g.,
electro- or HF-surgical devices) may take place.
Warning:
Using multiple devices for patient screening could re-
sult in excessive leakage current above the allowed
value!
Warning:
When using the device on patients with active
implants, such as Cardiac pacemakers, peripheral
nerve stimulation devices, tongue pacemaker etc.,
medical professionals should be alert to possible
interference with the device or the implant.
Warning:
Applying the device to more than one patient at any
one time is not allowed.
Warning:
The device must not be operated in vehicles and
aircraft.
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
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