ICU Medical LifeCare PCA, Technical & Service Manual, Page: 16 / 148

SECTION 1 INTRODUCTION
LifeCare PCA 1 - 6 Technical Service Manual
The electromagnetic environment should be managed to permit the infusion system
to perform as intended without disturbing other equipment. The infusion system should
not be used adjacent to or stacked with other equipment. If the device must be used
adjacent to or stacked with other equipment, monitor the equipment to assure there is no
electromagnetic interference, and verify normal infuser operation.
Use of a shielded Ethernet cable (CAT5 STP or better) for plugging into the RJ-45 connector
is required. Using an unshielded Ethernet cable may result in increased emissions.
1.9
FCC INFORMATION
The LifeCare PCA has been tested and found to comply with the Class B limits for list
number 20837-04 Class a/b/g digital devices, pursuant to Part 15 of the FCC rules. These
limits are designed to provide reasonable protection against harmful interference.
The wireless LAN device in the connectivity engine has been evaluated and found to be
compliant with the requirements of FCC radio frequency exposure standards
(see the System Operating Manual) .
1.10
INFUSION SYSTEM INSTALLATION
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (e.g., IEC 60601-1 for medical equipment). If in
doubt,
contact ICU Medical .
Infusion system installation consists of unpacking, inspection, self test, and setting
the time and date.
1.10.1
UNPACKING
Inspect the shipping container as detailed in Section 1.10.2 . Use care when unpacking
the infusion system. Retain the packing slip and save all packing material in the event
it is necessary to return the infuser to the factory. Verify the shipping container contains
a copy of the
System Operating Manual .
1.10.2
INSPECTION
Inspect the shipping container for damage. Should any damage be found, contact
the delivering carrier immediately.
Inspect the infusion system periodically for signs of defects such as worn accessories,
broken connections, or damaged cable assemblies. Also inspect the infuser after repair
or during cleaning. Replace any damaged or defective external parts.
CAUTION: Infusion system damage may occur unless proper care is exercised
during product unpacking and installation. The battery may not be fully
charged upon receipt of the infuser.
CAUTION: Inspect the infuser for evidence of damage. Do not use the device
if it appears to be damaged. Should damage be found, contact ICU Medical.