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Para Systems Life Support Policy
As a general policy, Para systems Inc. (Para Systems) does not recommend the use of any
of its products in life support applications where failure or malfunction of the Para Systems
product can be reasonably expected to cause failure of the life support device or to signifi-
cantly affect its safety or effectiveness. Para Systems does not recommend its products for
use in direct patient care. Para Systems will not knowingly sell its products for use in such
applications unless it receives in writing assurances satisfactory to Para Systems that (a) the
risks of injury or damage have been minimized, (b) the customer assumes all such risks, and
(c) the liability of Para Systems Inc. is adequately protected under the circumstances.
Examples of devices considered to be life support devices are neonatal oxygen analyzers,
nerve stimulators (whether used for anesthesia, pain relief, or other purposes), auto transfu-
sion devices, blood pumps, defibrillators, arrhythmia detectors and alarms, pacemakers,
hemodialysis systems, peritoneal dialysis systems, neonatal ventilator incubators, ventila-
tors for both adults and infants, anesthesia ventilators, and infusion pumps as well as any
other devices designated as “critical” by the United States FDA.
Hospital grade wiring devices and leakage current may be ordered as options on many PARA
SYSTEMS UPS systems. PARA SYSTEMS does not claim that units with this modification
are certified or listed as Hospital Grade by PARA SYSTEMS or any other organization.
Therefore, these units do not meet the requirements for use in direct patient care.
EEC Conformity Declaration
- These devices comply with the regulations of the following guide-lines:
- 73/23/EEC guideline of the Council for approximation of the legal regulations of the
EC countries concerning the electrical apparatus within certain voltage toler-
ances, modified by the guideline RL 93/68/EEC of the Council.
- 89/336/EEC guideline of the Council for approximation of the legal regulations of
the EC countries concerning the electromagnetic compatibility, modified by the
guidelines RL 91/236/EEC, and 93/68/EEC of the Council.
- The compliance with the following standards proves the conformity:
- EN 50091-1
- EN 55022/EN 55011, class B.
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