Pulse oximeter MySign
®
S
2
Safety information
Unit
•
The MySign
®
S may not be operated in atmospheres that pose explosion risks.
•
The MySign
®
S may not be used during defibrillation.
•
A defective unit may not be used. Parts that are broken, worn out or contaminated must be
replaced.
•
The MySign
®
S and all accessory parts may only be used by persons who have the
appropriate education to guarantee proper handling.
•
Portable and mobile RF (radio frequency) communication devices (e.g. mobile phones) can
interfere with and disrupt electrical medical devices. Additional information about
electromagnetic compatibility (EMC) can be found in this manual or on our homepage.
•
Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided in this Operating Manual.
•
MySign
®
S is not suitable for operation in the vicinity of MRI devices or X-ray radiation and
may not be operated in the above environments.
•
Exceeding the operating parameters or disregarding the measurement conditions will lead
to incorrect measurements or, in severe cases, damage to the MySign
®
S
•
Incorrect use or positioning of the sensors can result in measurement errors and can lead to
constriction of body parts by the sensor cable, shearing off of skin portions by the sensor, etc.
•
Only the sensors and accessory parts approved by EnviteC-Wismar GmbH may be used
with the MySign
®
S. Sensors and accessories must be in flawless condition. The use of
foreign articles can lead to functional failures or loss of biocompatibility and may endanger
the patient.
•
The use of accessories, transducers and cables other than those specified could result in
increased EMC emissions or decreased EMC immunity. See section “15. Order Information”
for details.
•
The equipment should not be used adjacent to or stacked with other equipment and if
adjacent or stacked use is necessary, the equipment should be observed to verify normal
operation in the configuration in which it will be used.
•
The taking of medications that alter the blood color, the administration of intravascular dyes
(such as methylene blue or indocyanine green and other dyes) or a high level of
dysfunctional haemoglobin (e.g. carbon monoxide poisoning) can significantly falsify the
measurement result.
•
MySign
®
S is intended to support a diagnosis. MySign
®
S may only be used for
determination of a diagnosis within the context of other clinical evidence and symptoms. A
clinical evaluation based solely on the use of MySign
®
S is not permitted.
•
MySign
®
S is delivered in an appropriate shipping packaging. Do not use MySign
®
S or the
compatible sensors if one of the parts exhibits transport damage or other damage.
•
When using the system with patients, the system may not be connected to a computer by
the data cable.
•
The setting of extreme alarm limits can override the alarm function, which could be
dangerous for the patient.
Rechargeable battery
•
Do not throw into fires.
•
Do not damage or change the battery's structure in any way.
•
Do not allow to come into contact with fluids.
•
Do not store with other metallic objects as this could cause the battery to short-circuit.
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