1.6 USER QUALIFICATION
Technical Service Manual
1 - 5
LifeCare PCA
1.6
USER
QUALIFICATION
The LifeCare PCA with ICU Medical MedNet
infusion system is intended for use at the
direction or under the supervision of licensed physicians or certified health care
professionals who are trained in the use of the pump and the administration of parenteral
and epidural fluids and drugs and the corresponding warnings and precautions. Training
should emphasize the assessment and monitoring of patients receiving potent analgesic
medications, and appropriate treatment for possible adverse reactions.
1.7
ARTIFACTS
Nonhazardous, low-level electrical potentials are commonly observed when fluids
are administered using infusion devices. These potentials are well within accepted safety
standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG,
and EEG machines. These artifacts vary at a rate that is associated with the infusion rate.
If the monitoring machine is not operating correctly or has loose or defective connections
to its sensing electrodes, these artifacts may be accentuated so as to simulate actual
physiological signals.
To determine if the abnormality in the monitoring equipment is caused by the infuser
instead of some other source in the environment, set the device so that it is temporarily
not delivering fluid. Disappearance of the abnormality indicates that it was probably
caused by electronic noise generated by the infuser. Proper setup and maintenance
of the monitoring equipment should eliminate the artifact. Refer to the appropriate
monitoring system documentation for setup and maintenance instructions.
1.8
ELECTROMAGNETIC
COMPATIBILITY
The LifeCare
PCA has been tested and found to comply with electromagnetic compatibility
(EMC) limits as specified in IEC 60601-1-2:2007. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
The equipment generates, uses, and may radiate radio frequency energy if not installed
and used in accordance with the instructions. It may interfere with other devices
in the vicinity
(see the System Operating Manual)
.
There is a shared responsibility between manufacturers, customers, and users to assure
that medical equipment and systems are designed and operated as intended.
Medical electrical equipment requires special precautions regarding electromagnetic
compatibility.
CAUTION:
Portable and mobile RF communications equipment, such as
cellular telephones, two-way radios, Bluetooth
™
devices, and microwave ovens
in close proximity to the infusion system may affect wireless and wired
communications and degrade performance of the system. Operation of the
infuser under such conditions should be avoided.