User's Manual

US-ENGLISH – 31
 IEC 60601-1-2 (2007): Electromagnetic compatibility - Medical
electrical equipment. General requirements for basic safety and
essential performance - Collateral standard
 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