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WARNING:
High Frequency Oscillatory and Jet Ventilator Circuits
• Some high frequency ventilator circuits require a one-way valve to prevent high
NO delivery.
• Place the Bunnell Life Pulse in Standby prior to suctioning the patient to avoid
NO delivery transiently exceeding the set dose by up to 30 ppm. Press ENTER to
reestablish ventilation as soon as the catheter is removed from the airway. This
will limit the extent of over delivery above the NO set dose.
• Do not use dose settings above 40 ppm with the Acutronics Fabian HFO
ventilator. Bidirectional flow through the Injector Module may cause over-delivery
which can lead to measured NO values greater than 100 ppm
Maintenance
• For continued protection against hazard, replace the fuses only with the correct
fuse type and rating.
• Handle and dispose of sensors according to facility biohazard policies. Do not
incinerate.
• If the Injector Module has been used in the wet/humidified part of the breathing
circuit, it should be sterilized between each patient use.
• INOmax DS
- 4 kV input to output isolation
- 4 kV input to mains isolation, and
- an internal "reference voltage" "U" (as defined in section 20.3 of IEC60601-
1 ed. 2) of less than or equal to 50 VDC or 50 VRMS and dielectric isolation
certified in accordance with IEC 60601-1. Interface cabling must not go outside of
the room (e.g., into walls where potential isolation issues could exist). Adherence
to the above provides compliance to clause 20.3 "Value of test Voltage" in edition
2 and clause(s) 8.5.4 "Working Voltage" and Clause 8.8.3 "Dielectric Strength" in
edition 3.
• RS232 cable must be shielded. The RS232 cable shield shall have a minimum
of 90% coverage. The shield shall only be connected at one end of the cable to
minimize noise induced by ground currents.
Manually Bagging a Patient with an Injector Module
• The hyperinflation bag will, under some conditions, contain NO
one ppm. Use of large tidal volume breaths may expose the patients to the NO
present in the bag for part of the breath. In general, if the inspiratory flow rate
induced by the manual ventilation does not exceed the fresh gas flow rate,
the patient should not be exposed to the concentrations of NO
hyperinflation bag.
• Adult and infant hyperinflation bags generate more NO
minute ventilation. If use of the bag is interrupted (for example to adjust the
tracheal tube), before resuming ventilation of the patient, the user should squeeze
the bag several times to empty residual gas from the bag.
• Because of the potential for inhalation of excessive concentrations of NO
the difficulty in monitoring the peak inhaled NO
a hyperinflation bag or self-inflating bag is intended only for short term use.
• The monitoring system within the INOmax DS
within the hyperinflation bag or self-inflating bag devices and the alarms for
excessive NO
iv
should only be connected to RS-232 ports that have:
IR
cannot warn of NO
produced within the manual bag system.
2
2
in excess of
2
present in the
2
when used at lower
2
concentrations, ventilation with
2
will not detect generation of NO
IR
Part No. 20717 Rev-01
2
, and
2
2
2014-07
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