Freedom KS2-00-KNEE1-KT, KD2-00-KNEE2-KT, Plié 2.0 Instructions For Use Manual

INSTRUCTIONS FOR USE

Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 1

Table of Contents

Product Number: KS2-00-KNEE1-KT/KD2-00-KNEE2-KT

Appropriate Use! 5
Symbols Legend! 6
Safety Information! 6
Knee Functions! 8
Technical Data! 8

Plié® 2.0 MPC Knee Specifications! 8
Battery and Battery Charger Specifications! 8
Environmental Specifications! 8
Storage! 8
Water Resistance! 8
Cleaning! 8
Finishing Options! 9

Battery and Power Information! 9

Battery Charging! 9

Software! 9

Installation! 9
Plié 2.0 Control! 10
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 Classification! 19
Directive 2002/96/EC on Waste Electronic & Electrical Equipment (WEEE)! 19
Conformite Europeenne and Authorized Representative Identification! 19

Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 2

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Plié® 2.0 MPC Knee (images not to scale)

Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 3

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Recommended Foot Components

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Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 4

Pictured

Part Description

Part Number

Included w/knee

Quantity

Available

Separately

A

BCDEFGHIJKLMNOPQR

Plié MPC Knee

KS2-00-KNEE1-00

NA

Plié® 2.0 MPC Knee, Threaded Top

KD2-00-KNEE2-00

NA

Wireless USB Adapter

KS1-00-BLUE2-00

✓

1

✓

Battery Case

✓

1

Software CD-ROM

KS2-00-SFTW1-00

✓

1

✓

Lithium Ion Battery (w/battery case)

KS1-00-BATT1-00

✓

2

✓

Battery Charger with Car Adapter

KS1-00-CHRG1-00

✓

1

✓

Air Pump with Hose Adapter

KS1-00-AIRP1-00

✓

1

✓

Hose Adapter for Air Pump

KS1-00-VALV1-00

✓

1

✓

Stance Bezel Kit, Replacement

KS1-00-BEZL1-KT

1

✓

O-rings, set of 5

KS1-00-RING1

5

✓

Air Cap, Replacement

KS1-00-PLUG1-00

1

✓

EUROPEAN ADAPTER

KS1-00-ADPTE-00

International only

1

✓

EUROPEAN BATTERY CHARGER

KS1-00-CHRGE-00

International only

1

✓

Battery Cap, Replacement

KS1-00-BCAP1-00

1

✓

Plié MPC Knee Case

KS1-00-CASE1-00

✓

1

✓

Protective Cover, Replacement

KS2-00-PROC1-00

1

✓

Quick Reference Guide

KS2-00-QREF1-00

✓

1

✓

Instructions for Use

KS2-00-TMAN1-00

✓

1

✓

User Guide

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 is appropriate for users with the potential or capability:

• of negotiating obstacles in the community or workplace.

• exerting sufficient hip joint voluntary muscle control.

• who would benefit from microprocessor controlled knee stability.

• of ambulating with variable cadence and/or descending stairs and ramps.

The Plié® 2.0 MPC Knee is not appropriate for users:

• having inadequate hip joint voluntary muscle control.

• having inadequate cognitive ability to charge the batteries and care for the device.

• desiring stance flexion knee motion on level ground.

• with body weight exceeding: 125 kg (276 lbs.) for moderate activity.

• with body weight exceeding: 100 kg (220 lbs.) for high activity.

Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 5

Symbols Legend

Tip

The following symbols are found on the Plié® 2.0 MPC Knee:

• Attention, refer to Plié® 2.0 MPC Knee Instructions for Use.

• Type BF applied part.

• Conformité Européene (European conformity).

• Federal Communications Commission (USA conformity).

• Separate collection for electrical and electronic equipment.

The following symbols are found within this Prosthetist Instructions for Use:

• Warning! Failure to adhere to this warning may result in user injury, knee damage, or limit the
function of the knee.

• Tip! This information will help the prosthetist and/or user understand the knee.

Safety Information

Prior to use, the prosthetist should discuss the following warnings with the user to prevent injury.

• (Threaded top) The rotation set screw of a three- or four-prong lamination adapter should be aligned posterior
and square to the knee. The proximal threaded top should be disengaged a maximum of 259º from full
insertion into a three- or four- prong lamination adapter. Failure to properly insert the threaded top into a
three- or four-prong lamination adapter may result in damage, cause user injury, and will void the warranty.

• Without power, the Plié® 2.0 MPC Knee will not release into swing phase. In this powered-down mode, the
knee will default to the stance flexion resistance setting. Insert a charged battery to resume normal knee
function.

• 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
may be required to increase the air pressure to resume normal function.

• The Plié® 2.0 MPC Knee requires air pressure for normal operation. A cylinder air pressure of less than 20
PSI may detrimentally affect the stance flexion resistance. The user should be provided with the included air
pump and instructed of its proper use. The user will be required to maintain sufficient air pressure by
periodically recharging the air reservoir, using the provided air pump. The cylinder air pressure should not
exceed 100 PSI.

• The threaded cap for the swing flexion resistance should remain threaded in the port except when the user is
adjusting the air pressure. The threaded cap functions as a secondary seal and prevents lint and debris from
contaminated the air valve seat. The threaded cap should be gently tightened with fingers or a 4mm allen key.

• If the user changes shoe heel height, the alignment may become unstable. An adjustable heel height
prosthetic foot is recommended or the user should be provided with heel wedges to accommodate various
heel heights.

Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 6