User's Manual

28 Regulatory Information
Safety Evaluations
The Hub has been tested by Underwriters Laboratories
(UL Classified) for safety in accordance with the following
safety standards:
USA
• ANSI/AAMI ES60601-1 Medical Electrical Equipment – Part 1:
General requirements for basic safety and essential performance
EU and CB Scheme
• IEC 60601-1 Medical Electrical Equipment – Part 1: General
requirements for basic safety and essential performance
• IEC 60601-1-6 General requirements for basic safety and
essential performance – Collateral Standard: Usability
• IEC 60601-1-8 General requirements for basic safety and
essential performance – Collateral Standard: General
requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
• IEC 60601-1-11 General requirements for basic safety and
essential performance – Collateral Standard: Requirements for
medical electrical equipment and medical electrical system used
in the home healthcare environment
Federal Communications Commission (FCC)
Information
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to
operate the equipment.
The Hub complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not
cause harmful interference and (2) this device must accept any
interference received, including interference that may cause
undesired operation.