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NOTE: ETSI EN 300 328, clauses 4.3.1.7 and 4.3.1.12 require radios to automatically reduce power output when other
2.4 GHz energy sources are present. The radio complies with ETSI EN 300 328, excluding clauses 4.3.1.7 and 4.3.1.12
in order to provide wireless communication and patient monitoring. Communication verification instructions are provided
in the Instructions for Use.
22 In "Appendix A: Specifications," in the "General" section, in the "Environment" subsection, the following environmental
specifications override the specifications in revision E of the instructions for use:
Specification Type
Operating Temperature
Range
Storage and Transport
Temperature Range
Operating Relative Humidity
Range
Storage and Transport
Relative Humidity Range
Operating Pressure Range
Storage and Transport
Pressure Range
23 In "Appendix A: Specifications," in the "Explanation of Symbols" section, added the following:
Symbol
6
Specification
Cart and all other accessories not specified below: 10 to 35°C (50 to 95°F)
Universal Gating Interface: 18 to 24°C (64 to 75°F)
Cart and Universal Gating Interface: -20 to 50°C (-4 to 122°F)
ECG Electrodes: 10 to 32°C (50 to 90°F)
SpO2 attachments, ECG cables, Universal Gating Interface, and ECG electrodes: 15 to 80%,
non-condensing
NBP accessories: 10 to 80 percent, non-condensing
NBP accessories, SpO2 attachments, ECG cables, Universal Gating Interface, and ECG
electrodes:
5 to 80%, non-condensing
NBP accessories, SpO2 attachments, ECG cables, Universal Gating Interface, and ECG
electrodes:
708 hPA to 1020 hPA
NBP accessories, SpO2 attachments, ECG cables, Universal Gating Interface, and ECG
electrodes:
570 hPA to 1020 hPA
Meaning
Packaging Unit
ISO 7000-2794
To indicate the number of pieces in the package. Where a number is inserted
into the symbol to indicate the number of pieces in the package.
Medical Device
European Medical Device Regulation (EU) 2017/745
To indicate that the product is a medical device.
Importer
ISO 7000-3725
To indicate the entity importing the medical device into the locale.
Electronic Instructions for Use
ISO 7000-3500
To indicate that relevant information for use of the product is available in
electronic form in addition to, printed paper form.
Expression Model MR400 MRI Patient Monitoring System, Instructions for Use Addendum
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