Instructions for use Primus Infinity Empowered SW 4.5n 11
For your safety and that of your patients
Sterile accessories
Storing the instructions for use
Training
Training for users is available from the Dräger or-
ganization responsible, see www.draeger.com.
Emission of Radio Frequency Energy
For wireless communication with Infinity ID acces-
sories, this medical device is equipped with an
RFID (Radio Frequency Identification) system.
Any changes or modifications to the RFID system
must be implemented by properly trained service
personnel; otherwise patient safety may be nega-
tively affected.
This medical device was developed and produced
in such a manner that the emission limits for radio
frequency (RF) energy will not be exceeded. These
limit values are incorporated in international safety
standards such as IEC 60601-1-2 (EN 60601-1-2)
and have been defined by regulatory bodies such
as the Federal Communications Commission
(FCC Rules), Industry Canada (Radio Standards
Specifications), and the European Telecommunica-
tions Standards Institute (ETSI Standards).
The RFID system in this medical device complies
with Part 15 of the FCC regulations and its opera-
tion is subject to the following conditions: (1) This
device may not cause harmful interference, and (2)
this device must accept any interference received,
including interference that may cause undesired
operation.
WARNING
Risk of electric shock
Connecting equipment to the
auxiliary outlets on the an-
esthesia machine may result in
increased leakage current. If
the protective conductor on one of these de-
vices fails, the leakage current may exceed
the permissible values.
Check the leakage current when connecting
devices to the auxiliary outlets. If connecting
a device (or devices) increases the leakage
current to a value which exceeds the permis-
sible value, do not use the auxiliary outlets of
the anesthesia machine: use a separate wall
socket.
The system must fulfill the requirements for
medical electrical equipment in accordance
with the relevant standards, see "Technical
data", page 270.
CAUTION
Risk of medical device failure and of patient injury
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged, or if
there are other signs of non-sterility. Disposable
articles must not be reprocessed and resterilized.
Reuse, reprocessing, or resterilization can lead to
a failure of the medical device and cause injury to
the patient.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.
To Next Page
Loading...
