St. Jude Medical Wi-Box AO Instrucciones De Uso página 11

Table 7. Classifications
Wi-Box external power supply
AO IN, AO OUT
XPRESS/PSU
*Isolation
Compliance with Regulatory Requirements
Hereby, St. Jude Medical, declares that the Wi-Box™ AO transmitter is in compliance with the
essential requirements and other relevant provisions of Medical Device Directive (93/42/EEC), Radio
and Telecommunications Terminal Directive (1999/5/EC) and Quality System Regulation (US). A
copy of the Full Declaration of Conformity can be obtained by contacting the EU Representative.
This device complies with part 15 of the FCC Rules and RSS-210 of the IC Rules. C-tick compliance
with AS/NZS 4268. Operation is subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Guidance and Manufacturer's Declaration - Electromagnetic
Emissions
Wi-Box™ AO transmitter is intended for use in the electromagnetic environment specified below.
The customer or the user of this device should assure that it is used in such an environment.
Table 8. Guidance and manufacturer's declaration – Electromagnetic emissions
Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Electrical safety Class II
Galvanically connected together.
CF, Defibrillation Proof
CF, Defibrillation Proof
Electromagnetic environment - guidance
This device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
This device is suitable for use in all establishments
including domestic establishments and those directly
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