PowerDot PD-01 - Standards Compliance; FCC and Bluetooth Certification

30
Limitations:equipmentisnotsuitableforuseintheenvironmentswithahigh concentrationofoxygen
and/orflammableliquidsand/orflammablegas;donotusewithequipmentforelectrosurgeryorshort‐
waveormicrowavetherapy.
STANDARDS
PowerDotisbaseddirectlyonmedicaltechnology.
To guarantee your safety, the design, manufacturing
 and distribution of Po werDot are in conformity
withtherequirementsoftheEuropeanMedicalDeviceDire ctive 94/42/EEC.
The device is in confor mity with the number of internationally recognized standards: standard for
general safety rules for electromedical devices IEC 60601‐1, the standard for electromagnetic
compatibilityIEC60601‐1‐2,the
standardformedicalelectricalequipmentusedinthehomehealthcare
environment IEC 60601‐1‐11 and the standard for safety rules for nerve and muscle stimulators IEC
60601‐2‐10.
Directive2002/96/CEEWasteelectricalandelectronicequipment(WEEE).
IPRatingIP22
FCCandEN300328compatibility
ThedevicecomplieswithPart15of
FCCrules.Operationissubjecttothefollowingconditions:
a.Thisdevicemaynotcauseharmfulinterference,and
b.Thisdevicemustacceptanyinterferencereceived,includinginterferencethat may causeundesired
operation.
FCCID:
2AC2KPD001201400SMT
BluetoothSmartReadycompatibility
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