Application, Safety Information
Application, Safety Information
10
PHYSIO-PORT / PHYSIO-PORT AS
A8136 Revision A
1.3 Safety Information
Danger
Risk to Persons —
The equipment is not designed for use in
areas where an explosion hazard may
occur. Explosion hazards may result
from the use of flammable anesthetic
mixtures with air or with oxygen, nitrous
oxide (N2O), skin cleansing agents, or
disinfectants.
Warning
Risk to Persons —
Equipment may be connected to other
equipment or to parts of systems only when it
has been made certain that there is no danger to
the patient, the operators, or the environment as
a result. In those instances where there is any
element of doubt concerning the safety of
connected equipment, the user must contact the
manufacturers concerned or other informed
experts to find out whether there is any possible
danger to the patient, the operator, or the
environment as a result of the proposed
combination of equipment. The standards IEC
60601-1 or IEC 60950-1 must be observed in
any case.
Connection of this device to an IT-network that
includes other equipment could result in
previously unidentified risks to patients,
operators or third parties. The responsible
organization should identify, analyze, evaluate
and control these risks.
Changes to the IT-network could introduce new
risks that require additional analysis.
Changes to the IT-network include:
o
changes in network configuration
o
connection of additional items
(e.g. connecting another device to
another port of the PC can lead to
interference during data transfer)
o
disconnection of items
o
update or upgrade of equipment
PHYSIO-PORT devices may be connected to a
PC with PhysioPortWin. While the PHYSIO-
PORT devices are connected to a PC, they have
to be disconnected from the patient.
Chemicals required, for example, for the
maintenance of the equipment must under all
circumstances be prepared, stored, and kept at
hand in their specific containers. Failure to
observe this instruction may have severe
consequences.
