Mallinckrodt INOmax DSIR Plus MRI Operation Manual page 8

Use in a MR Environment continued
WARNING:
• The gauss alarm will sound if the INOmax DS
the MR scanner. If alarm sounds, move system away from the MR scanner until
the gauss alarm stops sounding.
• Always verify that the INOmax DS
positioning in the MR scanner room.
• Always verify that the INOmax DS
attached to the cart.
• Never attach an oxygen cylinder to the INOmax DS
• Arrange power cord, MR patient gas sample line, MR injector tubing and MR
injector module cable to avoid entanglement, strangulation and/or a trip hazard.
• If the cart fails to move when the brake handle is pulled, or moves when the brake
handle is not pulled, do not use the INOmax DS
representative.
Use Outside of Product Labeling
• The INOmax DS
usage, contraindications, warnings and precautions described in the INOMAX
(nitric oxide) drug package inserts and labeling. Refer to this material prior to use.
• Outside of the United States, use of the INOmax DS
the use in accordance with INOMAX nitric oxide for inhalation prescribing
information as established with the national health authority.
• Helium/oxygen mixtures should not be used with the INOmax DS
• The use of devices which radiate high-intensity electrical fields may affect the
operation of the INOmax DS
and life support equipment is mandatory whenever interfering devices are in
operation on or near a patient.
• The target patient population is controlled by the drug labeling for INOMAX and is
currently neonates. The INOmax DS
patient populations.
Ventilators and Breathing Devices
• The INOmax DS
sampling system at 230 mL per minute which can cause the ventilator to auto-
trigger. Adjusting the flow sensitivity may be necessary. The trigger sensitivity of
the ventilator should be checked after connecting the INOmax DS
the breathing circuit.
• Set the INOmax DS
to monitor any inadvertent changes in treatment.
• Be certain all cables and hoses are positioned to help prevent damaging or
occluding them.
• The use of pediatric and neonatal ventilator settings with adult size breathing
circuits can result in higher levels of NO
that is appropriate for the patient.
• The humidifier chamber volume should not be more than 480 mL to minimize
elevated NO
• The patient gas sample tee must have the INOmax DS
attached or be capped off to avoid loss of ventilator circuit pressure.
• Only use parts/accessories designated for use with this system.
vi
IR
IR
Plus MRI must only be used in accordance with the indications,
IR
Plus MRI. Constant surveillance of all monitoring
IR
Plus MRI subtracts gas from the breathing circuit via the gas
IR
Plus MRI alarm thresholds for the current patient conditions
IR
values.
2
Plus MRI system is too close to
IR
Plus MRI auto-brake is engaged after
Plus MRI and INOblender are securely
Plus MRI cart.
IR
Plus MRI and contact your local
IR
Plus MRI is limited to
IR
Plus MRI is not intended to be used in other
IR
. Always use the size of breathing circuit
2
Plus MRI sample line
IR
Plus MRI.
IR
Plus MRI to
IR
Part No. 20568 Rev-02
2015-08