Emissions And Immunity Information - Welch Allyn RPM-Scale100 Mode D'emploi

A-14 Appendices
Item
Electromagnetic compatibility
Software life-cycle processes
Usability

Emissions and immunity information

The Welch Allyn Remote Monitoring Scale RPM-SCALE100 is intended for use in the
electromagnetic environment specified below. The customer or user of the Welch Allyn
Remote Monitoring Scale RPM-SCALE100 should assure that it is used in such an
environment.
This equipment needs to be installed and put into service in accordance with the
information provided in the user manual.
Note
The Welch Allyn Remote Monitoring Scale RPM-Scale100 is intended for use in the electromagnetic environment
specified below. The customer or user of the Welch Allyn Remote Monitoring Scale RPM-Scale100 should assure that it
is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
CAUTION Wireless communications equipment, such as wireless home
network devices, mobile phones, cordless telephones and their base
stations, walkie-talkie can affect this equipment and should be kept at least
a distance d=3,3m away from the equipment.
As indicated in Table 6 of IEC 60601-1-2:2007 for ME Equipment, a typical
cell phone with a maximum output power of 2 W yields d=3,3m at an
IMMUNITY LEVEL of 3V/m).
Electromagnetic emissions
Compliance Electromagnetic environment - guidance
Group 1 The Welch Allyn Remote Monitoring Scale RPM-Scale100 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.
Class B
The Welch Allyn Remote Monitoring Scale RPM-Scale100 is suitable
for use in all establishments other than domestic establishments and
those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Not applicable
Welch Allyn Remote Monitoring Scale RPM-Scale100
Standard
IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC/EN 62304+AC Medical device software - Software life
cycle processes
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366)
IEC 60601-1-6 Medical electrical equipment - Part 1 -6 :
General requirements for basic safety and essential
performance - collateral standard : Usability