ENG
35
Page
of 44
09360 Issue 2
Vitalograph micro - Instructions for Use
customer or the user of the micro should assure that it is not used
in such an environment.
The Model
6300 micro
has been tested in accordance with:
EN60601-1:2006 + A1:2013 - Medical electrical equipment. General
requirements for basic safety and essential performance
EN 60601-1-2:2015
+
A1: 2021 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential performance
- Collateral Standard: Electromagnetic disturbances - Requirements
and tests.
EN 60601-1-11:2015 - Medical electrical equipment – Part 1-11:
General requirements for basic safety and essential performance –
collateral standard: Requirement for medical electrical equipment
and medical electrical systems used in the home healthcare
environment.
Coexistence: ANSI C63.27-2017 American National Standard for
Evaluation of Wireless Coexistence.
EN 60601-1-2:2015 + A1:2021 - Emissions tests
During the immunity testing below the device continued to
operate within specification
Emissions test
Compliance
Electromagnetic
environment - guidance
RF emissions
CISPR 11
Group 1
The Model 6300 micro
uses RF energy only for its
internal function. Therefore,
its RF emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
