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21 In "Appendix A: Specifications," in the "General" section, added the following note related to radio performance:
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, replaced the "Environment" subsection with the following:
Environment
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
6
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)
Batteries: 0 to 40°C (32 to 104°F)
Cart and Universal Gating Interface: -20 to 50°C (-4 to 122°F)
Wireless modules and all other accessories not specified be-
low: -20 to 60°C (-4 to 140°F)
Calibration gas: 18 to 25°C (65 to 77°F)
ECG Skin Prep Gel: Follow instructions on tube
ECG Electrodes: 10 to 32°C (50 to 90°F)
(When storing or transporting in temperatures beyond the
ranges specified above, remove the designated component
and store or move it appropriately.)
Cart, Universal Gating Interface, and all other accessories not
specified below: 15 to 80%, non-condensing
Module batteries: 15 to 90%, non-condensing
NBP accessories: 10 to 80%, non-condensing
Cart and all other accessories not specified below: 15 to 80%,
non-condensing
Module batteries: 15 to 90%, non-condensing
NBP accessories, ECG accessories, Universal Gating Inter-
face, and SpO2 accessories: 5 to 80%, non-condensing
Cart and all accessories: 708 hPA to 1020 hPA
Cart and all accessories not specified below: 708 hPA to
1020 hPA
NBP accessories, ECG accessories, Universal Gating
Interface, and SpO2 accessories: 570 hPA to 1020 hPA
Expression Model MR200 MRI Patient Monitoring System, Instructions for Use Addendum
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