Werbung
3
In the "Important Information" chapter, in the "Safety" 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 "Safety" section, in the "Electromagnetic Compatibility (EMC)" subsection,
added the following values:
Devices
IP5 to MR200
MR200 to wECG Module
MR200 to wSPO
Module
2
MR200 to IP5
wECG Module to MR200
wSPO
Module to MR200
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 text:
•
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, 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.
The MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to
provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System is intended for use by
healthcare professionals.
The MRI Patient Monitoring System provides monitoring for the following vital sign parameter: Electrocardiograph (ECG)
2
Maximum Power
Level
Power Level
19.63 dBm
19.63 dBm
6 (4 dBm+2 dBi)
1.50 dBm
6 (4 dBm+2 dBi)
0.50 dBm
19.54 dBm
19.54 dBm
5.6 (4 dBm+1.6 dBi)
1.00 dBm
5.6 (4 dBm+1.6 dBi)
0.55 dBm
Expression Model MR200 MRI Patient Monitoring System, Instructions for Use Addendum
Measured
Frequency Range
2402-2470 MHz
2402-2418 MHz
2404-2420 MHz
2402-2470 MHz
2402-2426 MHz
2404-2428 MHz
Measured Duty
Modulation
Cycle
Type
05.99%
GFSK
04.65%
GFSK
04.69%
GFSK
35.73%
GFSK
22.00%
GFSK
07.90%
GFSK
Werbung
