24
Standards Compliance
This device is designed to conform to the following standards:
•
IEC 60601-1 Medical Electrical Equipment, Part 1: General Safety Requirements
•
IEC 60601-1-2 3.1 Edition, Medical Electrical Equipment, Part 1-2: General Safety
Requirements – Collateral Standard: Electromagnetic Compatibility; Requirements and
Tests
•
ISO 8359 Oxygen Concentrators for Medical Use – Safety Requirements. RTCA DO 160
Note: IT-network is a system composed of wireless (Bluetooth) transmission
between the Inogen One G5 and the Inogen Connect Application.
•
Connection of the Inogen One G5 to an IT-Network could result in previously unidentified
risks to patients, operators or third parties.
•
Subsequent changes to the IT-network could introduce new risks and require additional
analysis
•
Changes to the IT-network include:
º Changes in the IT-network configuration;
º Connection of additional items to the IT-network
º Disconnecting items from the IT-network
º Updating equipment connected to the IT-network
Summary of Contents for One G5
Page 1: ...1 USER MANUAL ...
Page 2: ...2 ...
