For your safety and that of your patients
10
Instructions for use Babylog 8000 plus SW 5.n
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.
Patient monitoring
The user of the medical device is responsible for
choosing suitable monitoring that provides
appropriate information about medical device
performance and the patient's condition.
Patient safety may be achieved by a wide variety
of means ranging from electronic surveillance of
medical device performance and patient condition
to simple, direct observation of clinical signs.
The responsibility for selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Information on electromagnetic
compatibility
General information on electromagnetic
compatibility (EMC) according to international
EMC standard IEC 60601-1-2:
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information provided (see ''EMC
Declaration'').
Portable and mobile radio frequency
communication equipment can affect medical
electrical equipment.
WARNING
Risk of electric shock
Do not connect connectors with an ESD
warning symbol and do not touch their pins
without implementing ESD protective
measures. Such protective measures can
include antistatic clothing and shoes,
touching a potential equilization pin before
and during connection of the pins, or using
electrically insulating and antistatic gloves.
All users concerned must be instructed in
these ESD protective measures.
WARNING
Risk of device failure
Electromagnetic fields can compromise
proper operation of the device.
Electromagnetic fields are generated by, e.g.,:
– Mobile phones
– Radio frequency electrosurgical equipment
– Defibrillators
– Shortwave therapy equipment
Maintain sufficient safety distances, see EMC
declaration in chapter ''Technical data''.