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3
In the "Important Information" chapter, in the "About" section, in the introduction, added the following warning:
WARNING: The European Union REACH Regulation 1907/2006 requires Philips to provide chemical content information
for Substances of Very High Concern (SVHC), if they are present in the relevant article above a concentration of 0.1%
weight by weight. Information on substances contained in the Philips products can be found on the Philips REACH
website: www.philips.com/REACH.
4
In the "Important Information" chapter, in the "Electromagnetic Compatibility (EMC)" section, added the following values:
Devices
IP5 to MR400
MR400 to IP5
MR400 to wECG Module
MR400 to wSpO
Module
2
wECG Module to MR400
wSpO
Module to MR400
2
5
In the "Important Information" chapter, in the "Accessory List" section, added the following caution statement:
CAUTION: Do not modify the accessories.
6
In the "Getting Started" chapter introduction, added the following warnings:
WARNING: Closely monitor the patient during the MR procedure. If the patient reports sensations of heating or other
unusual sensation, discontinue the MR procedure immediately and perform a thorough assessment of the patient and
MR monitoring equipment.
WARNING: Artifacts due to proton emissions from accessories are possible. If artifacts occur, reposition the accessory or
change scan parameters to limit the impact on the image.
7
In the "Monitoring ECG" chapter introduction, added the following text:
•
The ECG cable is intended for multi-patient use.
•
WARNING: The ECG electrodes are single use. Do not reuse. Reusing a single use device can spread infection,
degrade performance and result in inaccurate measurements.
•
WARNING: Do not allow the ECG cable or ECG module to touch the patient's skin or the patient may be burned.
•
CAUTION: Use the electrodes immediately after opening the pouch.
8
In the "Monitoring ECG" chapter, in the "Quadtrode Electrodes" section, in the "Attaching the ECG Lead Cable"
subsection, step 2, edited the caution text as follows:
CAUTION: When inserting or removing the lead cable, or clip leads, only use the connector or clip; never pull or apply
excessive force to the wires. Otherwise, damage may occur.
9
In the "Monitoring ECG" chapter, added the following sections:
Intended Use
The ECG Cable's use enables the Intended Use of the connected compatible MRI Patient Monitoring System.
The ECG Electrode's use enables the Intended Use of the connected compatible MRI Patient Monitoring System.
2
Maximum Power
Level
Power Level
19.92 dBm
19.92 dBm
19.65 dBm
19.65 dBm
6 (4 dBm+2 dBi)
2.19 dBm
6 (4 dBm+2 dBi)
1.16 dBm
5.1 (4 dBm+1.1 dBi)
0.70 dBm
5.6 (4 dBm+1.6 dBi)
4.10 dBm
Expression Model MR400 MRI Patient Monitoring System, Instructions for Use Addendum
Measured
Frequency Range
2402-2470 MHz
2402-2470 MHz
2435-2472 MHz
2425-2471 MHz
2435-2480 MHz
2425-2479 MHz
Measured Duty
Modulation
Cycle
Type
09.12%
GFSK
35.16%
GFSK
30.40%
GFSK
30.30%
GFSK
14.20%
GFSK
03.33%
GFSK
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