Patient Safety; Patient Monitoring; Information On Electromagnetic Compatibility - Dräger Fabius Tiro Instructions For Use Manual

For your safety and that of your patients

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 users, and that certain
inherent characteristics of the medical device are
known to the user. Instructions and WARNING and
CAUTION statements are therefore largely limited
to the specifics of the Dräger medical device.
These instructions for use do not contain
references to various hazards which are obvious to
users who operate this medical device as well as
references to the consequences of medical device
misuse, and to potentially adverse effects in
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
parameters.

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.
10
Information on electromagnetic
compatibility
General information on electromagnetic
compatibility (EMC) according to the international
EMC standard IEC 60601-1-2:
Medical electric 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 page 182).
Portable and mobile RF communications
equipment can affect medical electrical equipment.
WARNING
Risk of electric shock
Do not connect connectors with an
ESD warning symbol and do not
touch the pins of such connectors
without implementing ESD protective
measures. Such protective measures may
include antistatic clothing and shoes,
touching a potential equalization pin before
and during connection of the pins, or using
electrically insulating and antistatic gloves.
All relevant users must be instructed in these
ESD protective measures.
WARNING
Risk of device failure
Electromagnetic fields, e.g., those generated
by radio frequency communication
equipment such as mobile phones, high-
frequency electrical surgery equipment,
defibrillators or shortwave therapy devices
can disrupt the function of the medical
device.
Only operate radio frequency devices at a
sufficient safety clearance of at least
20 cm (7.9 in).
Instructions for use Fabius Tiro SW 3.n