2.7 Reporting
Please note that any serious incident that has occurred in relation to the device
shall be reported to the manufacturer and the national authority of the country in
which the user and/or patient resides.
3. Technical specifications
Description
Operating temperature (to
maintain optimal battery life)
Storage and transport
temperature
(to maintain optimal battery life)
Operating humidity
(to maintain optimal battery life)
Storage humidity
Expected service life
Applied part
Mode of operation
Power source
Dimensions
Weight
Charge specification
4. Compliance
Device is tested and conforms to the IEC 60601-1-2 with test level adopted for
domestic environment.
14
Specification
+5 °C to +25 °C
+41 °F to +77 °F
-20 °C to +25 °C
-4°F to +77 °F
15% to 93% relative humidity,
700 hPa to 1060 hPa
0% to 45% relative humidity
1-5 years
Type BF Applied Part (entire device)
30 minutes of activation during a 24 hour
period
Internally powered
Provox SolaTone Plus 118 mm (4.6 inch);
Provox TruTone Emote 113 mm (4.5 inch);
Provox TruTone Plus 113 mm (4.5 inch)
Provox SolaTone Plus 130 g (0.29 pounds);
Provox TruTone Emote 130 g (0.29 pounds);
Provox TruTone Plus 131 g (0.29 pounds)
5 V, 750 mA minimum (or 0.75 A minimum)