10 Instructions for use Primus Infinity Empowered SW 4.5n
For your safety and that of your patients
Patient safety
The design of the medical device, the accompany-
ing documentation, and the labeling on the medical
device are based on the assumption that the pur-
chase and the use of the medical device are re-
stricted to persons familiar with the most important
inherent characteristics of the medical device.
Instructions and WARNING and CAUTION state-
ments are therefore largely limited to the specifics
of the Dräger medical device.
The instructions for use do not contain any informa-
tion 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 dif-
ferent underlying diseases
Medical device modification or misuse can be dan-
gerous.
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 med-
ical device performance and patient condition to di-
rect observation of clinical signs.
The responsibility for selecting the best level of pa-
tient monitoring lies solely with the user of the med-
ical device.
Information on electromagnetic compat-
ibility
General information on electromagnetic compatibil-
ity (EMC) according to international EMC standard
IEC 60601-1-2:
Medical electrical equipment is subject to special
precautionary measures concerning electromag-
netic compatibility (EMC) and must be installed and
put into operation in accordance with the EMC in-
formation provided (see page 271).
Portable and mobile radio frequency communica-
tion equipment can affect medical electrical equip-
ment.
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 meas-
ures can 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 users concerned must be instructed in
these ESD protective measures.
To Next Page
Loading...
