Instructions for Use | Technical Specifications
Standards Compliance 91
Standards Compliance
This device conforms to the following standards:
• IEC 60601-1-1 Medical electrical equipment. Part 1-1: General requirements for
safety. Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-11 Home Health Care Environment according to transit-operable
Device essential performance is specified in each of the following standards:
• ISO 80601-2-12: Medical electrical equipment. Part 2-12: Particular
requirements for basic safety and essential performance of critical care
ventilators
• ISO 80601-2-61 Medical electrical equipment. Part 2-61: Particular
requirements for basic safety and essential performance of pulse oximeter
equipment
• ISO 80601-2-55 Medical electrical equipment. Part 2-55: Particular
requirements for the basic safety and essential performance of respiratory gas
communication
• Bluetooth Core Specification version 4.1
• ISO/IEC 18092:2013: Information technology. Telecommunications and
information exchange between systems. Near Field Communication. Interface
and Protocol (NFCIP-1)
• ISO IEC 21481 Ed 2.0: Information technology. Telecommunications and
information exchange between systems. Near Field Communication Interface
and Protocol -2 (NFCIP-2)
• ISO/IEC 14443 Ed 2.0: Identification cards. Contactless integrated circuit cards.
Proximity cards.
• WLAN Standard: IEEE 802.11 (2012) b/g/n: Information technology.
Telecommunications and information exchange between systems. Local and
metropolitan area networks. Specific requirements. Part 11: Wireless LAN
Medium Access Control (MAC) and Physical Layer (PHY) Specifications
• Hereby, Respironics Inc. declares that this class 1 radio equipment is in
compliance with Directive 2014/53/EU. The full text of the EU declaration of
conformity is available at the following internet
address: http://incenter.medical.philips.com/PMSPublic
To Next Page
Loading...
