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Compliance

Taska Prosthetics is certified to ISO 13485

TASKA Hand

CE Marked for MDR in Europe

General Safety:

IEC60601-1-1:2012
Protection against electrical shock – Class II.
Not suitable for use in the presence of flammable gases.

IEC 60601-1-2:2014
Rated to CISPR 11 (Class B): Suitable for use in a Home Healthcare and Professional Healthcare Facility.

Protection Rating against ingress of water and dust:
IP67

Intentional RF transmitter (Bluetooth RF transmitter):
Complies with FCC title 47 part 15
Contains Transmitter Module FCC ID: QOQBLE113
Contains Transmitter Module IC: 5123A-BGTBLE113

FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter meets both portable and mobile limits as demonstrated in the RF Exposure Analysis. This transmitter must not be co-located or operate in conjunction with any other antenna or transmitter except in accordance with FCC multi-transmitter product procedures.

IC Statements:
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 10 11 Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. Statements for Radio Equipment Directive:

Hereby, TASKA Prosthetics Limited declares that the TASKA Hand is in compliance with Directive 2014/53/EU.

Operational frequency band: 2402 to 2480 MHz
Maximum radio-frequency power: 1 dBm

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