HLD PhysioTouch A02 - Page 35

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Environmental conditions
Use 10°C - 40°C,
humidity 15 - 93% non-condensing,
altitude 0 - 3000 m
Storage and transport 0° - 40° C,
humidity 15 - 95% non-condensing,
altitude 0 - 3000 m
Classification
Medical device (CE-MDD), class 2a
Conformity to standards
ISO 13485:2003
IEC 60601-1
IEC 60601-1-11
Performance specifications
Negative pressure
adjustment
Range 0-250 mmHg
Accuracy ± 10% + ± 10 mmHg
Pulsation adjustment Range 0.5-5 s
Accuracy ± 10% + ± 0.05s
Vibration adjustment Range 20-90 Hz
Accuracy ± 10%
Designed lifetime
5 years