User's Manual

US-ENGLISH – 27
─ EN 50371 (2002) : Generic standard to demonstrate the compliance
of low power electronic and electrical apparatus with the basic
restrictions related to human exposure to electromagnetic fields (10
MHz - 300 GHz)
─ EN 301 489-1 (v1.8.1) & EN 301 489-27 (v1.1.1): Electromagnetic
compatibility and Radio spectrum Matters (ERM); Electromagnetic
Compatibility (EMC) standard for radio equipment and services -
Part 1 : Technical Requirements and Part 27: Specific conditions for
Ultra Low Power Active Medical Implants (ULP-AMI) and related
peripheral devices (ULP-AMI-P)
─ EN 301839-1 (v1.3.1) & EN 301839-2 (v1.2.1): Electromagnetic
compatibility and Radio spectrum Matters (ERM); Short Range
Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI)
and Peripherals (ULP-AMI-P) operating in the frequency range 402
MHz to 405 MHz; Part 1: Technical characteristics and test methods
and Part 2: Harmonized EN covering essential requirements of
Article 3.2 of the R&TTE Directive
─ EN 62311 (2008) : Assessment of electronic and electrical
equipment related to human exposure restrictions for
electromagnetic fields (0Hz to 300 GHz)
─ EN 62209-2 (2010) : Human exposure to radio frequency fields from
hand-held and body-mounted wireless communication devices –
Human models, instrumentation and procedures – Part 2: Procedure
to determine the specific absorption rate (SAR) for wireless
communication devices used in close proximity to the human body
(frequency range of 30MHz to 6 GHz)
This information should not be used as a basis of comparisons
among devices since different parts of the standards mentioned may
have been used.
Sorin CRM declares that this device is in conformity with the essential
requirements of Directive 1999/5/EC on Radio and Telecommunications
Terminal Equipment, with the mutual recognition of their conformity
(R&TTE).