General Information - Lowenstein Medical Samoa Gebrauchsanweisung

Samoa / Samoa lite
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.
Warning:
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
Warning:
Caution must be taken to ensure that cables do not
encircle the patients neck. Special attention is
needed in the case of children.
Warning:
Before the battery is charged, the charger and, if
using the charging cradle, the battery must also be
checked for external damage!
Warning:
Before every application, the housing of the device
as well as the cables and sensors must be checked
for external damage!
Warning:
The device and PC software are not intended for
automatic diagnosis only. The measurement data
must be always reviewed and evaluated manually by
a qualified physician or healthcare professionals.

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 9 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 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;
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