Patient Safety; Patient Monitoring; Electromagnetic Compatibility (Emc) - Dräger Savina 300 Instructions For Use Manual

Patient safety

The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to persons familiar with the most
important inherent characteristics of the medical
device.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
The instructions for use do not contain any
information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring pa-
rameters.

Patient monitoring

The user of the medical device is responsible for
choosing a suitable patient monitoring system that
provides appropriate information on medical device
performance and patient condition.
Patient safety can be achieved by a wide variety of
means ranging from electronic surveillance of
medical device performance and patient condition
to direct observation of clinical signs.
The responsibility for selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Instructions for use Savina 300 SW 5.n
For your safety and that of your patients

Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility. During installation
and before initial operation, follow the information in
section: "EMC declaration" (page 219).
This device can be affected by other electrical
devices.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against elec-
trostatic discharge are employed in the follow-
ing situations:
– When touching the pins of connectors that
carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the follow-
ing measures and train the relevant person-
nel:
– Observe the ESD protective measures.
Such measures may include wearing anti-
static clothing and shoes, touching a po-
tential equalization pin before and while
making the connection, or using electrical-
ly insulating and antistatic gloves.
– Observe the requirements for the electro-
magnetic environment. Observe the fol-
lowing section: "Electromagnetic environ-
ment" (page 219).
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