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temperature: 50°C
Relative Humidity Range: 15-90%
Atmospheric Pressure Range: 700-1060 hPa
10.4.
Transport and Storage Conditions
Ambient Temperature Range: -20 to 50°C
Relative Humidity Range: 30 - 93% RH
10.4.1.
If
AcceleDent Optima
has been transported or stored at its maximum
or minimum transport or storage conditions, the product shall be allowed
to cool or warm for at least two hours within the environmental operating
conditions before use.
10.5.
The Activator is a Type BF Applied Part, meaning this medical device
has direct contact with the patient. Such devices shall be marked with
symbol.
10.6.
A Power Adapter intended for connection to the USB port of the Charging
Case shall comply with the relevant product standard e.g. IEC 60950-1 or
IEC 62368-1 for IT-equipment and the IEC 60601-series for Medical Electrical
Equipment. In addition, all such combinations – Medical Electrical Systems
– shall comply with the safety requirements stated in the general standard
IEC 60601-1, edition 3, clause 16. Any equipment not complying with the
leakage current requirements in IEC 60601-1 shall be kept outside the patient
environment i.e. at least 1.5 m from the patient support or shall be supplied
via a separation transformer to reduce the leakage currents.
10.7.
Use the provided Power Adapter or one that is certified as Class II
adapter with double or reinforced insulation. Such Power Adapter shall be
marked with
symbol or labeled Class II. The specifications of an appropriate
Power Adapter are detailed below:
10.7.1.
Certification: Class II, IEC 60950
Output Voltage: 5 V
Output Current Limit: 1 A
AC Input Voltage Range: 100-240 V
AC Input Current: 0.2 A
AC Input Frequency: 50/60 Hz
10.8.
Any person who connects external equipment to the USB connector
has formed a Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact a qualified medical
technician or your local representative.
