Regulatory Compliance, Disclosures, and Classification
Wireless Operation
Plié® 2.0 MPC Knee Bluetooth Certification QPLN Ref. No.: Q31606_WT11_SGS
The Plié® 2.0 MPC Knee complies with the following:
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FCC ID AMPCK001 or FCC ID QOQWT11. This device complies with Part 15 of the FCC Rules. 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.
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The Plié® 2.0 MPC Knee has been tested and found to comply with the EMC limits for the Medical Device
Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2). These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. The Plié® 2.0 MPC Knee generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with these
instructions, may cause harmful interference to other devices in the vicinity.
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IC Certificate 5123A-BGTWT11E
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EU Certificate EC/2006.20013C
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Radio Equipment Japan No: 07215089/AA/00 and 07215089/AA/01
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STSI EN 300-328 under R&TTE Directive 1999/5/EC
IEC/EN 60601 Classification
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Internally powered
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Type BF applied part
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Mode of operation: continuous
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Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Directive 2002/96/EC on Waste Electronic & Electrical Equipment (WEEE)
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We have marked the Plié® 2.0 MPC Knee with the “crossed out wheeled bin” as instructed by Article 10.3 of
WEEE, per Annex IV
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We include the following instruction required by Article 10 of WEEE for the Prosthetist to convey to the End
User:
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We instruct Users of the Plié® 2.0 MPC Knee in private households in the European Union not to dispose of
this device as unsorted municipal waste. Instead, contact the European distributor that imported this device
and follow their instructions concerning:
a. the return and collection systems available to you.
b. your role in contributing to the reuse, recycling and recovery of Waste Electronic and Electrical
Equipment and
c.
the potential effects on the environment and human health that result from the presence of hazardous
substances in electrical and electronic equipment.
Conformite Europeenne and Authorized Representative Identification
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We have marked the Plié® 2.0 MPC Knee with the CE Marking of Conformity required by Article 17 of
Directive 93/42/EEC concerning Medical Devices (Medical Device Directive), per Annex XII.
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Below, we mark this Instruction for Use with the required CE Marking of Conformity and identify our
Authorized Representative to the European Union.
Plié® 2.0 MPC Knee Instructions for Use
(R-720-109 Rev. E), English
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