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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:

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.

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.

IC Certificate 5123A-BGTWT11E   

EU Certificate EC/2006.20013C

Radio Equipment Japan No: 07215089/AA/00 and  07215089/AA/01

STSI EN 300-328 under R&TTE Directive 1999/5/EC

IEC/EN 60601 Classification

Internally powered

Type BF applied part

Mode of operation: continuous

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)

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

We include the following instruction  required by Article 10  of  WEEE  for  the Prosthetist to convey to the End 
User:

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

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.

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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        19

30 Fairbanks, Suite 114
Irvine, California 92618
Toll Free (888) 818-6777     
FAX (949) 672-0084

Содержание KD2-00-KNEE2-KT

Страница 1: ...Plié 2 0 MPC Knee Instructions for Use R 720 109 Rev E English 1 INSTRUCTIONS FOR USE ...

Страница 2: ...0 Plié Gait Lab 13 Alignment 14 Bench Alignment 15 Static Alignment 15 Dynamic Alignment 16 Set Up 16 1 Establish Wireless Connection 16 2 Plié 2 0 Setup Wizard 16 3 Adjust Manual Hydraulic Settings 17 4 Optimize Microprocessor Settings 17 5 Document 18 Technical Support 18 Warranty 18 Service and Repair 18 Regulatory Compliance Disclosures and Classification 19 Wireless Operation 19 IEC EN 60601 ...

Страница 3: ...Plié 2 0 MPC Knee Instructions for Use R 720 109 Rev E English 3 H D C A B E F G Plié 2 0 MPC Knee images not to scale ...

Страница 4: ...Plié 2 0 MPC Knee Instructions for Use R 720 109 Rev E English 4 N I J K L M O Recommended Foot Components P Q R ...

Страница 5: ...e KS2 00 UMAN1 00 1 Plié Lower Shank Cosmetic Foam KS2 00 COVR 00 Highlander foot component FS3 Runway foot component RS2 or RS2 K1 Renegade foot component RS1 or RS6 Appropriate Use The Plié 2 0 MPC Knee should only be used by individuals with lower limb loss including knee disarticulation hip disarticulation transfemoral amputees and or individuals with congenital anomalies The Plié 2 0 MPC Knee...

Страница 6: ...unction Use only the batteries and battery charger intended for use with the Plié 2 0 MPC Knee Extreme temperatures will affect the performance of the Plié 2 0 MPC Knee Allow sufficient time for the knee to return to temperatures within the specified operating temperature range before use High elevations and cold temperatures will affect the knee internal air pressure In these conditions the user ...

Страница 7: ...ricate the shaft with a few drops of 3 in1 oil All purchased serviced and repaired Plié 2 0 MPC Knees are sent to customers with the following default hydraulic cylinder manual settings swing flexion 30 psi swing extension 0 stance flexion 5 Additionally the computer settings are sent to customers with default settings The prosthetist should adjust the manual and computer settings to meet the need...

Страница 8: ...Hydraulic cylinder default manual settings swing flexion 30 psi swing extension 0 stance flexion 5 Patents USPO 5 190 126 6 978 872 and 7 655 050 Other patents pending Battery and Battery Charger Specifications Battery type lithium ion Battery voltage 3 7 VDC Battery capacity 710 mAh Battery life 24 hours depending on use Charger input voltage 12 VDC AC power adapter input voltage 100 240 VAC 50 6...

Страница 9: ...ed to 90 capacity the Charge indicator LED will flash red and green When the battery is fully charged the Charge indicator LED will illuminate green Charging of a fully discharged battery takes approximately two hours Use only approved batteries and battery charger battery part AG BATT XX and battery charger part AG CHRG XX where XX specifies current revision number Use of unapproved batteries and...

Страница 10: ...isconnect Select the Connect Disconnect to establish or discontinue a wireless connection 4 Toe Threshold T1 The Toe Threshold determines how much force the user must load the toe to initiate swing phase during ambulation A higher value requires more toe loading by the user to initiate swing phase The Toe Threshold may be adjusted by moving the slider or typing a numerical value in the text box an...

Страница 11: ...ssion of the Plié 2 0 Setup Wizard see section titled Set Up 10 More Params Select More Params to open the auxiliary Additional Parameters window for the advanced Stumble Recovery parameters Figure D 11 Data Monitor Select Data Monitor to open an auxiliary window for diagnostic use only 12 Live Data Select Live Data to view the auxiliary Plié Real Time Data Display window for viewing data as the u...

Страница 12: ...ime Data Display is illustrated in Figure C The Plié 2 0 Real Time Data Display is useful for verifying calibration of the sensors If the user unweights the knee the Moment trace should have zero value If the knee is fully extended the Angle trace should have zero value Additional Parameters The Additional Parameters window provides access to advanced stumble recovery parameters via two tabs Level...

Страница 13: ...lect the optimal Toe Threshold Swing Transition and advanced Stumble Recovery Parameters Levels I II Plié Gait Lab The Plié Gait Lab software allows the prosthetist access to the userʼs gait data as viewed by the microprocessor The Plié Gait Lab may be used as a tool for comparing the performance of various prosthetic feet identifying gait anomalies simulating the microprocessor algorithm ensuring...

Страница 14: ...he prosthesis the prosthetist should measure the userʼs hip joint range of motion ROM on the prosthetic side to determine if the user has a hip flexion contracture Figure E If present the userʼs hip flexion contracture should be accommodated by attaching the socket to the prosthesis with an appropriate amount of flexion Figure F Failure to sufficiently accommodate a hip flexion contracture may com...

Страница 15: ...guidelines An inherently unstable trochanter knee ankle TKA alignment may cause a rapid extension moment at the knee joint after midstance The non adjustable stance extension resistance may be insufficient to dampen the extension moment if the user does not exert sufficient voluntary control and or if the alignment recommendations are not implemented The recommended inherently stable alignment of ...

Страница 16: ...e 1 Establish Wireless Connection To optimize the microprocessor communication must first be established between the programming computer and the userʼs Plié 2 0 MPC Knee a Open the Plié 2 0 Control software Start All Programs Plié Plié Control b Insert the provided USB wireless adapter in any available USB port c Remove and re insert the battery in the knee Battery insertion activates the knee wi...

Страница 17: ...or the remainder of the knee set up proceed with the Plié 2 0 Setup Wizard Plié Control Setting Wizard a Instruct the user to ambulate with variable cadences including fastest and slowest walking speeds until 20 steps are shown in the Steps box The Plié 2 0 Setup Wizard will select optimal T1 T2 values and transfer them to the knee The suggested values in the Set T1 and T2 boxes should have minima...

Страница 18: ...n a secure computer To save select Save Settings for the File menu Plié Control File Save Settings The userʼs saved settings can be transferred to a loaner knee However due to continuous design improvements the settings may not be optimal If problems are experienced with a loaner knee simply follow the steps provided in this Set Up section Technical Support For Technical Support please contact Fre...

Страница 19: ...mable anesthetic mixture with air or with oxygen or nitrous oxide Directive 2002 96 EC on Waste Electronic Electrical Equipment WEEE 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 We include the following instruction required by Article 10 of WEEE for the Prosthetist to convey to the End User We instruct Users of the Plié 2 ...

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