IP21
IX. Executive Standards
The product should be in accordance with the following standards and
regulations:
1) Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance (EN 60601-1:2006 + A1:2013)
2) Medical electrical equipment - 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 (EN60601-1-11:2015)
Standby
Please refer to the user manual
Temperature limitations. It indicates the range of temperature
to which medical devices can be safely exposed. The upper
and lower temperature limits shall be indicated near the upper
and lower horizontal lines.
Humidity limits. It indicates the range of humidity to which
medical devices can be safely exposed. The humidity limits
shall be indicated near the upper and lower horizontal lines.
Atmospheric pressure limits. It indicates the range of
atmospheric pressure to which medical devices can be safely
exposed. The atmospheric pressure limits shall be indicated
near the upper and lower horizontal lines.
Direct Current
Electrodes
Dustproof and waterproof level, to avoid the falling of solid
objects larger than 12.5mm and the vertical penetration of
water to cause adverse effects.