Instructions for Use Addendum - English
This addendum contains a list of changes and new information for the Expression Model MR400 MRI Patient Monitoring
System Instructions for Use, Revision E. Keep this addendum with the instructions for use.
1
In the front matter, in the "Regulatory" section, added the following subsections:
Authorized Representative
ECG cables, ECG electrodes,
compliant to European Medical Device Regulation (EU MDR) 2017/745. The Authorized Representative for the
European Union (as required by the EU MDR 2017/745) is:
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684PC, Best
The Netherlands
CE Mark
ECG cables, ECG electrodes,
accessories compliant to EU MDR
EU Importer
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Straße 2
71034, Böblingen
Germany
Brazilian Sponsor and Registration
Registro ANVISA
10216710332
Responsável Técnico:
Thiago Medeiros de Abreu
CREA/SP: 5070149021
Detentor do Registro
Philips Medical Systems Ltda.
Av. Marcos Penteado de Ulhoa Rodrigues, 401 Setor
Parte 39 - Tamboré, Barueri/SP,
Brasil – CEP 06460-040
2
In the "Important Information" chapter, in the "About" section, added the following statement:
Any serious incident that has occurred in relation to this device should be reported to Philips and the competent authority
of the Member State in which the user and/or patient is established.
SpO
clips and grips, Universal Gating Interface, and NBP cuffs are Class I accessories
2
SpO
clips and grips, Universal Gating Interface, and NBP cuffs are Class I
2
1
