User's Manual

Item Standard
User manual EN 1041 Medical equipment manufacturers to provide
information
General Requirements for Safety
IEC 60601-1+A1 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
IEC 60601-1-11 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
Electromagnetic compatibility 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
Software life-cycle processes
IEC/EN 62304+AC Medical device software - Software life
cycle processes
Usability
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
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.
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.
Note 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
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 Compliance Electromagnetic environment - guidance
14 Appendices Welch Allyn Remote Monitoring Scale RPM-Scale100