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
HDCABEF
G
Plié® 2.0 MPC Knee (images not to scale)
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 3
NIJKLMO
Recommended Foot Components
PQR
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
• If the user changes shoe heel height, the Plié Control Threshold Setting may require adjustment as the knee
requires a minimum user toe loading (adjustable Toe Threshold) to release into swing phase.
• During repetitive activities without swing phase, such as the use of exercise equipment, the user should turn
the stance flexion resistance setting counterclockwise to the “Off” position with a 4mm allen key. After the
activity, the user should adjust the stance flexion resistance to its previous setting.
• The Plié® 2.0 MPC Knee intended use does not include knee stance flexion gait on level surfaces. Failure to
adhere to the alignment recommendations may result in undesirable user gait characteristics on level
surfaces. As the stance extension resistance is non-adjustable, certain undesirable gait characteristics may
only be eliminated via alignment, user physical therapy, and/or user gait training.
• The intended use of the Plié® 2.0 MPC Knee is normal ambulation. If the user intends to run with the Plié
MPC Knee, the computer and manual settings may require adjustment for optimal running function.
• The user should avoid stepping backwards as the knee stability may be compromised.
• The userʼs socket should not contact the hydraulic cylinder. Failure to comply may result in cylinder damage
and will void the warranty.
• The Plié® 2.0 MPC Knee should not be submerged in water to depths greater than 0.5 m (1.6 ft). The user
should not intentionally expose the knee to water during activities such as showering, swimming, fishing, etc.
Failure to comply may cause corrosion and/or noise and will void the warranty.
• If exposed to chlorinated and/or salt water environments, such as walking along the shore, the knee should
be rinsed with fresh water.
• While the Plié® 2.0 MPC Knee withstands moist environments, continual use in wet conditions may result in
corrosion and/or undesirable operational noise.
• If the hydraulic cylinder shaft seal causes noise during user ambulation, lubricate 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 needs of each Plié® 2.0 MPC Knee user prior to use.
• The Plié® 2.0 MPC Knee is not field-serviceable and may only be repaired by Freedom Innovations, LLC.
Attempts to disassemble, repair, or modify the Plié® 2.0 MPC Knee, including changes to the tension on any
of the threaded fasteners, could put the user at risk for serious injury and will void the warranty.
• If applying talcum powder when donning the prosthesis, the user should take care to prevent the powder from
contacting the hydraulic cylinder shaft. Talcum powder may cause noise and/or acceleration of shaft seal
wear.
• A thin film of oil on the hydraulic cylinder is normal. Only return the Plié® 2.0 MPC Knee for repair if the oil
appears to be leaking from the hydraulic cylinder.
• Freedom Innovations, LLC is responsible for radio frequency compliance. Changes to any portion of the
wireless system not expressly approved by Freedom Innovations may void the user's authority to operate the
equipment.
• A wireless USB adapter is supplied with the Plié® 2.0 MPC Knee. While other wireless adapters may be
compatible, Freedom Innovations, Inc. only provides technical support for the supplied device.
• During wireless transfer of data files from the knee to the computer, the Plié® 2.0 MPC Knee will remain in
stance phase. Instruct the user to refrain from ambulating by sitting or standing during data file transfers.
• If the Plié® 2.0 MPC Knee causes harmful interference with other wireless devices, the user may alleviate the
interference by: reorienting, relocating, and/or increasing the separation distance between the receiving
device and the Plié® 2.0 MPC Knee. To determine if the Plié® 2.0 MPC Knee is the cause of interference,
remove and reinsert the battery.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 7
Knee Functions
The Plié® 2.0 MPC Knee is a single axis prosthetic knee joint system providing microprocessor control of both the
swing and stance phases of gait. The microprocessor monitors an embedded load sensor and an angle sensor to
precisely control the transitions between the stance and swing phases of gait. Three manual settings allow the
hydraulic cylinder to provide adjustable resistance for stance flexion, swing flexion, and swing extension. The
hydraulic cylinder also provides non-adjustable stance extension resistance. The Plié Control software allows the
knee function to be optimized for each individuals userʼs gait, including the stumble recovery parameters. The
Gait Lab software provides the prosthetist with access to recorded data files of the microprocessor.
Technical Data
Plié® 2.0 MPC Knee Specifications
Microprocessor control cycle: 1000 Hz
Actuator speed: 10 milliseconds
Operating voltage: 3.6-4.2 VDC
Maximum user weight (moderate activity): 125 kg (276 lbs.)
Maximum user weight (high activity): 100 kg (220 lbs.)
Build clearance (pyramid top): 235mm (Figure J)
Build clearance: (Figure K)
Product weight (pyramid top): 1235 g (2.7 lbs.)
Product weight (threaded top): 1243 g (2.74 lbs.)
Maximum flexion angle (pyramid top): 125°
Maximum flexion angle (threaded top): 117°
Frame/cylinder construction: aluminum
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, 50/60 Hz
Environmental Specifications
Storage temperature range: -20 °C to 80 °C (-4 °F to 176 °F)
Operating temperature range: -5 °C to 45 °C (23 °F to 113 °F)
Storage and operating relative humidity range: 0% to 100%, including condensation
Storage and operating atmospheric pressure range: 500 hPa to 1060 hPa (7.3 psi to 15.4 psi)
Storage
Store the Plié® 2.0 MPC Knee in a fully extended, unbent position. To conserve battery power during storage,
remove the battery from the knee.
Water Resistance
The Plié® 2.0 MPC Knee resists low-pressure water spray and occasional, brief submersion in water up to a
depth of 0.5 m (1.6 ft). If the knee is sprayed by or submerged in salt water or chlorinated water, immediately rinse
with fresh water and allow to dry. When changing the battery, the user should verify that the battery cap is
correctly seated. If water enters the battery compartment, failure of the battery and/or knee electronics may result.
Cleaning
For cleaning, the outside surfaces of the frame and hydraulic cylinder may be wiped down with isopropyl alcohol.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 8
Finishing Options
Tip
The Plié® 2.0 MPC Knee may be finished with a cosmetic/protective cover. However, the choice of cover material
may affect normal knee function. A cover should be modified or not used if it detrimentally affects the knee
performance. A discontinuous, two-piece cover is recommended as its impact on knee performance is minimal.
!Care should be taken during cover fabrication to ensure the user has adequate access to the battery
!compartment and the posterior manual knee settings of the hydraulic cylinder.
Battery and Power Information
Two lithium-ion batteries and a battery charger are included with the Plié® 2.0 MPC Knee. A fully charged battery
will provide the user with approximately one day of typical use. The battery charger is compatible with both of the
included AC and DC charging cords.
!During transport, the spare battery should be stored in the provided plastic case to avoid the risk of a
!battery short circuit and to keep the battery terminals clean.
Battery Charging
It is not possible to overcharge the Plié® 2.0 MPC Knee batteries using the provided charger:
a. Connect the battery charger into an appropriate power source. The “Status” indicator LED will illuminate red,
indicating the battery charger is powered on.
b. Align the red dot on the battery with the red dot on the charger. Insert the battery into the charger so it is
completely seated. The “Charge” indicator LED will illuminate red, indicating the battery is charging.
c. When the battery is charged 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/or battery
!chargers may cause product malfunction and will void the warranty.
Software
The Plié® 2.0 MPC Knee requires software to program the knee via a wireless connection. The provided CDROM installs two programs, Plié Control and Plié Gait Lab. Although the default computer settings may function, it
is the responsibility of the prosthetist to optimize the computer settings for each user. Prior to software installation,
verify the computer meets the following minimum requirements:
• Microsoft Windows XP w/Service Pack 2 or later operating system
• 1.0 Mhz processor
• 256K Random Access Memory (RAM)
• USB port
Installation
To ensure successful installation of the software, follow these steps:
a. Login to the computer as an administrator.
b. Insert the provided Plié® 2.0 MPC Knee Prosthetist Set-Up Software CD-ROM.
c. Follow the subsequent installation screens, agreeing to the terms of the software License Agreement.
d. Access the software programs and an electronic version of this document (Start>All Programs>Plié).
! The software may be installed on an Apple Macintosh computer if a Microsoft Windows operating !syste m
! is installed in a separate partition. Apple Bootcamp or a third party emulation software is required.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 9
Tip
Figure A Figure B
11123456789101213
14
Plié 2.0 Control
The Plié 2.0 Control software is necessary for programming Plié® 2.0 MPC Knees (Figure A). The Plié 2.0 Control
consists of a main window and four auxiliary windows. The auxiliary windows may be accessed from the main
window. The Plié 2.0 Control software is compatible with Agility™ MPC Knees, Plié MPC Knees, and Plié® 2.0
MPC Knees. To access the Plié 2.0 Control, select from the All Programs menu (Start>All Programs>Plié>Plié
Control).
! To achieve a successful user outcome, it is not necessary to understand all the features of the Plié
! 2.0 Control software. For instructions specific to setting-up a Plié® 2.0 MPC Knee, see section titled,
! “Set-Up.”
Main Window
The numbered items below refer to the corresponding numbers in the Plié 2.0 Control main window of Figure A.
1. Knee Connection - Active wireless knees are displayed in this drop-down menu.
2. Search - select the Search icon to find active wireless knees.
3. Connect/Disconnect - 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 and
selecting the “Enter” key. A green circle indicates the values shown are the values stored in the knee memory.
5. Swing Transition (T2) - The Swing Transition determines when the knee will release into swing phase. A
higher value will release into swing earlier as it corresponds to a point earlier on the userʼs moment curve.
The Swing Transition may be adjusted by moving the slider or typing a numerical value in the text box and
selecting the “Enter” key. A green circle indicates the values shown are the values stored in the knee memory.
6. Reset - Select Reset to restore a knee to the default computer settings.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 10
7. Calibrate - Select Calibrate to establish the reference zero values for the embedded sensors.
8. Wireless Sync - Select Wireless Sync if the software and knee fail to sync (circles remain red).
9. Setting Wizard - Select the Setting Wizard to open the Plié 2.0 Setup Wizard window (Figure B). The Plié 2.0
Setup Wizard includes a sophisticated algorithm designed to optimize the Toe Threshold, Swing Transition,
and the advanced Stumble Recovery (Plié Control>More Params). For advanced discussion 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
user ambulates (Figure C).
13. Steps Total - Indicates how many times the prosthetic toe of the user exceeded the Toe Threshold value.
14. Steps Swing - Indicates how many times the knee released into swing phase.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 11
Figure C
Tip
Figure D
Plié 2.0 Real Time Data Display
The Plié 2.0 Real Time Data Display allows the viewing of live data as the user ambulates. The Plié 2.0 Real Time
Data Display provides a data rate of 4 Hz (4 samples per second). Due to the limited data stream bandwidth
(knee microprocessor data rate is 1000 Hz), the Plié 2.0 Real Time Data Display should not be used for setting
the userʼs computer parameters. To access the Plié 2.0 Real Time Data Display, select the Live Data icon in the
Plié 2.0 Control main window. To stream live data, select the Stream Data icon. The Plié 2.0 Real Time 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 I & Level II). To optimize the advanced stumble recovery parameters, follow the steps provided in the Plié
2.0 Setup Wizard. To access the Additional Parameters window, select the More Params icon in the main Plié 2.0
Control window. The Additional Parameters window is illustrated in Figure D.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 12
trochanter
knee
ankle
Figure E Figure F Figure H Figure I
Manually adjusting the Additional Parameters is not recommended. If the Setup Mode box is checked, the
advanced stumble recovery is not active. The knee should only be in Setup Mode during set-up.
Plié 2.0 Setup Wizard
The Plié 2.0 Setup Wizard optimizes all the computer settings for Plié® 2.0 MPC Knees only. To access the Plié
2.0 Setup Wizard, select the Setting Wizard icon from the main Plié 2.0 Control window. The Plié 2.0 Setup
Wizard is illustrated in Figure B.
The Plié 2.0 Setup Wizard progresses through four steps to optimize the userʼs computer settings. Data is
recorded as the user ambulates. The Plié 2.0 Setup Wizard analyzes the recorded data to select the optimal Toe
Threshold, Swing Transition, and advanced Stumble Recovery Parameters (Levels I & II).
Figure G
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 proper Plié 2.0 MPC Knee function, and
documenting the progress of the user. The Plié Gait Lab is optional and not necessary for the successful fitting of
the Plié 2.0 MPC Knee. To access the Plié Gait Lab, select from the Programs menu (Start>All
Programs>Plié>Plié Gait Lab). The Plié Gait Lab software is illustrated in Figure L.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 13
Tip
Swing
Stance
14mm
Swing Flexion
235m
Swing
Figure J
! The white tabs on the bottom and left frames of the data window allow the data view to be modified. To
! scroll the data, simultaneously place the cursor between the white tabs, hold the left mouse button, and
! drag the mouse. To collapse or expand the data, simultaneously place the cursor on a white tab, hold the
! left mouse button, and drag the mouse.
Stance Flexion
Swing Extension
Figure K
235mm
Alignment
Careful attention to the alignment of the socket, Plié® 2.0 MPC Knee, and the prosthetic foot is essential to a
successful user outcome. The prosthesis alignment should account for the range of motion (ROM), voluntary
control, and balance of individual users. Proper alignment and user voluntary control are essential to knee stability
during stance phase.
Prior to assembly of the 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 compromise the
userʼs function during standing and ambulation (Figures G & H).
!During standing, an unaccommodated hip flexion contracture may prevent the user from standing
!straight, compromising the userʼs balance (Figure G). Additionally, an unaccommodated hip flexion
!contracture may cause excessive lumbar lordosis, compromising the structural integrity of the userʼs
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 14
Figure L
! spinal column (Figure H).
!During ambulation, an unaccommodated hip flexion contracture may cause an excessively asymmetrical
!gait pattern.
Bench Alignment
The Plié® 2.0 MPC Knee was designed to be in a fully extended position during stance phase for level ground
ambulation. Consequently, an inherently stable trochanter-knee-ankle (TKA) alignment is essential to a successful
user outcome with the Plié MPC Knee. The referenced trochanter on the lateral socket should be placed on or up
to 5mm anterior to an imaginary vertical line falling through the knee joint axis (Figure I). Due to the unique
characteristics of each user, the optimal alignment may not fall within the recommended 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 the Plié® 2.0 MPC Knee may differ from other knee
!joints. Consequently, if a new socket is not fabricated for use with a Plié® 2.0 MPC Knee, the socket
!attachment component may require re-lamination to the socket to achieve the recommended alignment.
Static Alignment
Prior to ambulation, observe the overall alignment with the prosthesis donned on the user:
a. Instruct the user to stand between parallel bars.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 15
b. With equal weight on each limb, adjust the height of the prosthesis as necessary.
Tip
Tip
c. Ensure the trochanter-knee-ankle (TKA) alignment follows the recommendations of inherent stability.
d. Ensure the transverse rotation of the knee and foot is appropriate.
e. Instruct the user to sit in a chair. Adjust the height of the knee joint axis to match the contralateral limb as
closely as possible.
!To prevent risk of injury to the user, perform the static alignment, dynamic alignment, and set-up between
!parallel bars.
Dynamic Alignment
Prior to Set-Up, allow the user to adjust to the prosthesis:
a. Instruct the user to take a lunge step with the prosthesis. The lunge motion will allow the user to feel the
stance flexion resistance and develop confidence. Repeat as necessary.
b. Instruct the user to carefully ambulate. Teach the user to flex the ipsilateral hip extensor muscles at initial
contact to stabilize the knee joint.
c. Train the user to load the prosthetic toe to initiate the swing phase transition.
d. Train the user to take steps of equal length.
e. Adjust the alignment in the transverse, coronal, and sagittal planes as necessary.
f. Train the user to sit in a chair using the stance flexion resistance.
Set-Up
While the Plié® 2.0 MPC Knee may function adequately at the default settings, both the computer and manual
hydraulic settings should be optimized for each user. Follow the five steps below to set-up the Plié® 2.0 MPC
Knee.
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 wireless module for five
minutes.
d. Select the Search icon.
e. After the knee is found, select the Connect icon to establish a wireless connection. If the Connect icon
changes to a Disconnect icon, the wireless connection is verified.
! If the software and knee do not appear to be communicating, select the Wireless Sync icon to re-
! establish the wireless connection.
! The green LED inside the knee frame only remains illuminated when the a wireless connection has been
! established with a computer.
2. Plié 2.0 Setup Wizard
Open the Plié 2.0 Setup Wizard (Plié Control>Setting Wizard). The Welcome window will appear.
a. If you are programming a knee for the first time, select Next.
b. In the Setup and Calibration window, select Setup Mode.
The Setup mode should only be enabled when setting up a knee. The advanced Stumble Recovery
Parameters (Levels I & II) are not active and the stumble recovery function is limited in the Setup mode.
c. As the user unweights the prosthesis, select the Calibrate icon to calibrate the load sensor. Instruct the user
to ambulate or weight the prosthesis in a fully extended position to calibrate the angle sensor. Select OK
when finished.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 16
d. Instruct the user to ambulate. If the knee does not release into swing, lower the To e Threshold setting in the
Tip
Tip
Tip
Plié Control window until the knee releases.
e. Select Next to continue.
3. Adjust Manual Hydraulic Settings
Adjust the default manual hydraulic settings in the following order to ensure the knee motion is smooth and
symmetrical for the user (Figure K). Higher numerical values provide increased resistance for each hydraulic
resistance setting.
a. Using the pneumatic pump, adjust swing flexion resistance (heel rise).
! The pressure on the air pumpʼs pressure gauge indicates the air pressure inside the knee. Air pressure
! in the knee drops when the air pump is inserted in the knee, not when it is removed. When the air
! pump is removed from the knee, a sound of air leaking may be heard. This sound is the expelling of air
! from the air !pump hose to the atmosphere. Approximately ½ the pressure in the knee is lost when the air
! pump is inserted.
b. Adjust swing extension resistance with a 4mm allen key (terminal impact).
! The extension control valve used to modify the swing extension resistance is a cam and rotates 360°
! without damaging the knee. A line indicates the value of the current setting (0-9).
c. Adjust stance flexion resistance with a 4mm allen key (stair/ramp descent resistance). Optimize performance
for stair/ramp descent.
d. After completing the manual hydraulic settings, select Next in the Manuel Adjustment window to continue.
!The stance flexion resistance also doubles as the resistance provided for stumble recovery. Caution must
!be exercised when adjusting the stance flexion resistance to ensure adequate resistance is present for
!stumble recovery.
4. Optimize Microprocessor Settings
For 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 minimal variance with the
Toe Threshold and Swing Transition values in the Plié 2.0 Control window.
! As the data is collected for the T1 and T2 values, instruct user to finish ambulating with his/her slowest
! walking speed to ensure T1 is set appropriately.
b. Select the Next icon to proceed to the main Record Normal Walk window.
c. In the Record Normal Walk window, select the Start Recording icon. Instruct the user to take twenty steps at
his/her normal walking speed. Once complete, select the Stop Recording icon.
!The dialog box, “Notify user download is about to start,” functions as a reminder to instruct the user to sit
!or stand as the knee will not release into swing during data file transfers.
d. Select the Save Data icon. The normal walk recorded data file will be transferred wirelessly to the computer.
e. Select the Next icon to proceed to the main Record Fast Walk window.
f. In the Record Fast Walk window, select the Start Recording icon. Instruct the user to take twenty steps at
his/her fastest walking speed. Once complete, select the Stop Recording icon.
g. Select the Save Data icon. The fast walk recorded data file will be transferred wirelessly to the computer.
h. Select the Next icon to proceed to the main Record Slow Walk window.
i. In the Record Slow Walk window, select the Start Recording icon. Instruct the user to take twenty steps at
his/her slowest walking speed. Once complete, select the Stop Recording icon.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 17
j. Select the Save Data icon. The slow walk recorded data file will be transferred wirelessly to the computer.
Tip
Tip
Tip
k. Select the Next icon to proceed to the Set Knee window.
l. In the Set Knee window, select the Apply to Knee icon. The Plié 2.0 Setup Wizard will transfer the optimal
Stumble Recovery (Levels I & II) parameters to the knee.
! When recording the three data files, capture the best data possible to ensure the advanced Stumble
! Recovery parameters (Levels I & II) are optimal. Instruct the user to ambulate outside the parallel bars if
! ! stability is not a concern.
5. Document
After completing the knee set-up, provide documentation in the userʼs records.
a. Record the knee Serial Number in the userʼs chart. To maintain user confidentiality, the Serial Number is
referenced when technical support, warranty repairs, or warranty service is required.
! The Serial Number can be found on the sticker inside the knee frame or in the main Plié 2.0 Control
! window when a wireless connection is established with the knee.
b. Record the three manual hydraulic settings in the userʼs chart: swing flexion, swing extension, stance flexion.
c. Save the userʼs computer settings on 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 Freedom Innovations toll-free at 1-888-818-6777.
Warranty
The Plié® 2.0 MPC Knee purchase includes a 36 month warranty covering all manufacturer defects. The warranty
remains in place only when the product is used as intended, without modifications, following all manufacturerʼs
recommendations. Additionally, the Plié MPC Knee must be returned for service at the specified intervals for the
warranty to remain in effect.
The batteries, battery charger, and accessories are provided with a 12 month warranty.
Service and Repair
For the warranty to remain in effect, the knee must be serviced 12 and 24 months after purchase. A loaner knee is
provided at the time of knee service.
For knee repairs, please contact Freedom Innovations toll-free at 1-888-818-6777. A loaner knee will be provided
upon request. For service and/or repair, please ship the knee in the provided shipping case.
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 18
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.
30 Fairbanks, Suite 114
Irvine, California 92618
Toll Free (888) 818-6777
FAX (949) 672-0084
Plié® 2.0 MPC Knee Instructions for Use (R-720-109 Rev. E), English! ! ! ! ! 19
Loading...