Philips Expression MR400 - Indications for Use; Contra-indications

ExpressionMR400InstructionsforUseImportant Information1‐3
Indications for Use
TheExpressionMR400MRIPatientMonitoringSystemisintended forusebyhealthca re
professionalstomonitorvitalsignsofpatientsundergoingMRIproceduresandtoprovidesignals
forsynchronizationfortheMRIscanner(alsoreferredtoas“triggering”or“gating”). The
ExpressionMR400providesmonitoringforthefollowingvitalsignsand
parameters:
electrocardiogram(ECG),pulseoximetry(SpO
2
),non‐invasivebloodpressure(NIBP);and
optionally,invasivebloodpressure(IBP),carbondioxide(CO
2
)andrespirationrate,anesthetic
agents,oxygen(O
2
),nitrousoxide(N
2
O),andtemperature.
Notes
• The MR400 is intended to be used to monitor the vital signs of a patient in an MR magnet
room. Monitoring outside the magnet room (e.g., the MR induction and/or MR recovery
areas) is acceptable for the short duration of time in which the patient is being prepared for
the MR scan and during the recovery period within the MR. This system is not intended for
use on a patient being transported outside of a health care facility.
• The MR400 is intended for use on patients receiving MR scans, which may include
neonatal, pediatric, or adult patients. If determined by a qualified healthcare provider, this
may also include pregnant patients.
• The bellows-derived respiration rate measurement is not intended for vital sign monitoring.
Contra-indications
ThisPhilipsproductshouldnotbeusedifanyofthefollowingcontra‐indicationsexistorare
thoughttoexist.Thisdeviceiscontra‐indicatedforpatientswithmetallicwires,implants,stents,
etcetera.Screenall patientsformetallicwires, implants,stents,etceterapriortoMR
procedures.Theseelectricalconductors
willreactwiththeMRenvironmentorwiththe
accessory(ifapplieddirectlyovertheconductor),thusincreasingtheriskofheating.The
warningsbelowrefertotheExpressionMR400MRIPatientMonitoringSysteminitsentirety.
WARNINGS
• The Expression MR400 MRI Patient Monitoring System is not intended for use with
patients using pacemakers or electrical stimulators.
• Do not use if MR workers are present who have metallic wires, implants, stents, et
cetera. Screen all MR workers for metallic wires, implants, stents, et cetera, prior to
MR procedures when using the Expression MR400 MRI Patient Monitoring System in
the MR magnet room.
• Do not use on patients with metallic wires, implants, stents, et cetera. Screen all
patients for metallic wires, implants, stents, et cetera, prior to MR procedures. These
electrical conductors will react with the MR environment or with the accessory (if
applied directly over the conductor), thus increasing the risk of heating.