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For your safety and that of your patients
16
Instructions for use – Infinity Acute Care System – Monitoring Applications VG6.n
Electrical safety
Connection to hospital network
Many medical devices manufactured by Dräger use
networks to transmit patient data in real-time and to
notify clinical users of alarm conditions. Hospitals
should refer to IEC 80001-1 before attempting to
connect such medical devices to their IT networks.
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.
These 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 dif-
ferent underlying diseases
Medical device modification or misuse can be
dangerous.
WARNING
The leakage current increases when multiple
medical devices are connected to a patient.
Make sure that the galvanic isolation of each
device is suitable for the intended application.
Connect only equipment that is set up and
tested according to IEC standards to the
analog and digital signal inputs and outputs.
Connect only passive USB devices to the
IACS (Infinity Acute Care System) Cockpit.
To protect the patient from possible injury due
to electrical shock, peripheral devices should
only be connected to a monitor within the
same room. The installer or service provider
should verify that the leakage current of the
interconnected system meets the electrical
safety requirements of IEC 60601-1.
WARNING
Because of the risk of electric shock, never
remove the cover of a device while it is in use
or plugged into a power socket.
CAUTION
Connect the PS250 or the P2500 with an attached
power cable only to hospital-grade electrical
power sockets to make sure that it is properly
grounded.
CAUTION
To avoid injuring the patient, do not touch any
connector or mounting screw on the device when
you are touching the patient. Do not allow the
conductive parts of electrodes and cables to
contact other conductive parts or the ground.