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Indications For Use; Contra-indications - Philips Expression MR400 Instructions For Use Manual

Mri patient monitoring system.
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Indications for Use

The Expression MR400 MRI Patient Monitoring System is intended for use by healthcare 
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
optionally, invasive blood pressure (IBP), carbon dioxide (CO
agents, oxygen (O
Notes

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
Expression MR400 Instructions for Use                                                                                                                Important Information   1‐3
), nitrous oxide (N
2
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.
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.
), non‐invasive blood pressure (NIBP); and 
2
) and respiration rate, anesthetic 
2
O), and temperature.
2

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