During transport or storage, the temperature should not exceed the limit values of -20 °C (-4 °F) to +60° C
(+140 °F) at a relative humidity of 90% RH, non-condensing (for a limited time).
Non-clinical testing (US only)
The devices covered within this user guide have undergone tests for the relevant non-clinical performance
testing and biological endpoints in accordance with standards identified below:
•
Electrical safety testing is performed according to IEC 60601-1:2005 + A1:2012+A2:2020, IEC 60601-2-
66:2019, IEC 60601-1-11 Edition 2.0 2015-1, IEC 62133-2 Edition 1.0 2017- 02 and IEC 62368-
1:2018/COR1:2020.
•
Electromagnetic compatibility (EMC) testing is performed according to IEC 62479:2010, ANSI IEEE C63.19-
2019 and IEC 60601-1-2:2014+A1:2020.
•
Radio and Telecommunication testing is performed to be in compliance with applicable parts of the FCC rules
in title 47 of the CFR.
•
Electroacoustic testing is performed according to ANSI/ASA S3.22-2014 and ANSI/CTA 2051:2017
•
Usability Engineering was performed in compliance with IEC 62366-1:2015
The devices covered in this user guide passed all tests for the relevant non-clinical performance testing and
biological endpoints, namely cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO
10993-10:2010).
Similarly, usability testing and software verification and validation demonstrated mitigation of risks to an
acceptable level as well as reasonable assurance of safe and effective device performance.
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Regulatory information
