43
Environmental conditions during operation
Temperature +41° - +104°F
Air pressure 700 … 1060 hPa 3000 m (ASL)
Relative humidity 15 … 93 % RH, +158 °F non-condensing
Storage and transportation
Temperature -13° - +158°F
Air pressure 700 … 1060 hPa 3000 m (ASL)
Relative humidity 15 … 93 % RH, +158°F non-condensing
Protection against moisture
IP 21 protection against vertically dripping water
IP 22 protection against dripping water when the enclosure
is tilted up to 15°
Expected lifetime
Expected minimum lifetime of the equipment and its
applicators is 10 years. The determined minimum lifetime
of 10 years is a purely statistical value that is influenced by
many factors, such as the intensity of the application, the
maintenance, climatic conditions, etc.
Maximum temperatures
B.SPOT 108°F
Standard marking
IEC 60601-1 Medical electronic equipment
IEC 60601-1-2 Electromagnetic compatibility
IEC 60601-1-6 Usability
IEC 60601-1-11 Requirements for medical electrical
equipment and medical electrical
systems used in the home
healthcare environment
IEC ISO 14971 Application of risk management
on medical products
IEC 62304 Software life cycle processes
IEC 62366 Application of usability on
medical products
1960-2002-BEDIENANL-B.BOX-USA-FDA-2020-US-en-v13-Akku Rev20_4.indd 431960-2002-BEDIENANL-B.BOX-USA-FDA-2020-US-en-v13-Akku Rev20_4.indd 43 04.11.2020 08:47:3104.11.2020 08:47:31
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