Physio Logic Essentia+ - Standards and Compliance Information

EssentiA
+
Instruction Manual
25
Disposal
• Please dispose of the device, components and optional accessories
in accordance with local regulations. Unlawful disposal may cause
environmental pollution. (Waste Electrical and Electronic Equipment).
• Contact your local distributor for information regarding disposal of the unit.
Storage Environment
Humidity
Classification:
Ingress Protection
Rating:
Temperature:
Internal Powered Equipment,Type BF .
Cuff is the Applied Part
IP20, Indoor Use Only
-25
o
C ~ 70
o
C (-13
o
F~158
o
F)
≤93% RH
Specifications are subject to change without notice.
International Standards:
1. IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
2. EN 60601-1-2: 2015 - Medical electrical equipment. General requirements for
basic safety and essential performance. Collateral Standard. Electromagnetic
disturbances. Requirements and tests.
3. IEC 60601-1-11:2015 - Medical electrical equipment – Part 1-11: General
requirements for basic safety and essential performance – Collateral Standard:
Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment.
4. Electromagnetic Compatibility: This device fulfills the stipulations
of the International Standard IEC 60601-1-2