2.4 Regulatory Symbols
The following Table 1 gives an explanation of the symbols used on the device itself, on the
packaging and the accompanying documents including the Operation Manual.
Table 1 Regulatory Symbols
Caution, consult accompanying documents
Warning, consult accompanying documents
Return to authorized representative, special disposal required
Applied part type B according to IEC 60601-1
Refer to operation manual (mandatory)
Transport and storage temperature range
Transport and storage humidity limitations
Transport and storage atmospheric pressure limitations
Conforms to European Medical Device Directive 93/42/EEC
2.5 Device Control
The user of the device should perform a subjective device check once a week
(ISO 8253-1). See Section 6.5 for a checklist.
For annual calibration see Sections 2.6 and 3.2.