PROTEOR PLIE 3 Microprocessor Knee Instruction Manual

PROTEOR PLIE 3 Microprocessor Knee

INCLUDED ITEMS

#| Part Description| Part Number| Included/Sold Separately
---|---|---|---
1| Pyramid Top Plie Knee with Black Cover

or

Threaded Top Plie Knee with Black

Cover

| ****

KS3-00-KNEE1-00

or

KD3-00-KNEE2-00

| ****

Included

2| Wireless USB Adapter| KS1-00-BLUE1-00| Included
3| Lithium Ion Battery (2 pc)| KS1-00-BATT2-00| Included
4| Battery Charger| OTS0401| Included
5| Air Pump with Hose Adapter| KS1-00-AIRP1-00| Included
6| Smooth Hose Adapter for Air Pump| SGK0213| Included

DESCRIPTION AND PROPERTIES

A. Description
The Plié® 3 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 individual user’s gait, including the stumble recovery parameters. The Gait Lab software provides the prosthetist with access to recorded data files of the microprocessor for analysis and documentation.

B. Properties
Device Information

Battery Information

Expected Lifetime

The expected lifetime of the Plié 3 MPC Knee is defined by the warranty period and contingent on adherence to the service plan

INTENDED USE/INDICATIONS

The Plie© 3 MPC Knee is appropriate for users who would benefit from the safety inherent in the stability of a microprocessor-controlled knee. This medical device is supplied to healthcare professionals (prosthetists) who will train the patient in its use. The prescription is made by a doctor together with the prosthetist, who assess the patient’s ability to use it. This device is for SINGLE PATIENT use. It should not be reused on another patient.

The Plia 3 MPC Knee is intended for use as a component in a prosthetic leg for individuals with lower-limb loss including:

• transfemoral amputees
• knee disarticulation amputees
• hip disarticulation amputees
• individuals with congenital lower-limb abnormalities

It is recommended specifically for patients with medium activity level (2.5) to high activity patients (4):Maximum weight (load carrying included):

• for moderate activity: 125 kg / 275 lbs.
• for high activity: 100 kg / 220 lbs.

CLINICAL BENEFITS

The Plie 3 MPC Knee is appropriate for users who would benefit from the safety inherent in the stability of a microprocessor-controlled knee. These users should also have the ability or have the potential to:

• negotiate obstacles in the community or workplace
• exert sufficient hip joint or pelvic voluntary muscle control
• ambulate with variable cadence
• descend stairs and ramps

ACCESSORIES AND COMPATIBILITIES

The device incorporates a male pyramid link that allows it to be used with female pyramid connectors for the Pyramid Top version and a M36 x 1.5 thread for the Threaded Top version.

ASSEMBLY AND PATIENT FITTING

A. Battery and Battery Cap

• Follow the Plié 3 Owner’s Guide on battery handling and charging.
• If power is lost from the Plié 3 knee, it will default to the Stance Flexion resistance setting and will not release into swing.
• Insert a charged battery when the Plié 3 MPC Knee low battery indicator is visible (symbolized by red blinking light visible on the left side of the knee viewed from posterior) prior to complete power loss to prevent potential personal injury.
• Use ONLY compatible Plié 3 MPC Knee batteries and charger.
• Store spare battery in the battery bag to avoid the risk of battery short circuit.
• Use a lint free cloth with or without isopropyl alcohol to wipe the battery compartment area and gasket on the bottom side of the cap (see pictures below). These areas need to be debris and lint free.

Battery Cap Opening & Closing

To open the battery cap, press down latch, this will cause the cap to spring open. To close the battery cap, press firmly on entire cap until latch engages. Do not submerse the knee in water when the battery cap is open at any time.

The following picture show the proper steps to open and close the battery cap. Steps to Open or Close the Cap

The following pictures shows the proper steps to utilizing the air pump.

1. Remove the Valve Plug
2. Insert Pump Tube and Pump Air
3. Remove the Pump Tube
4. Re-insert Valve Plug

• Pump tip must be clean and free of debris and lint before inserting.
• Knee must be fully extended when adjusting air pressure.
• After re-attachment, gauge reads about half of the pressure in the knee.

Alignment and Setup

Follow the Prosthetist Setup Guide to properly align and adjust the device. Two installation programs, Plié Control and Plié Gait Lab, are provided to optimize the computer settings for each patient. Verify the computer system minimum requirements before software installation (Microsoft Windows 7 or later operating system, 1.0 MHz Processor, 256K RAM and USB Port).

D. Alignment
Careful attention to the alignment of the socket in relation to the Plié® 3 MPC Knee and the prosthetic foot is essential for 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 the optimal function of the prosthesis. Prior to assembly of the prosthesis, the prosthetist should measure the patient’s hip joint range of motion (ROM) on the prosthetic side to determine if the user has a hip flexion contracture (Figure 1). If present, the user’s hip flexion contracture should be accommodated by attaching the socket to the prosthesis with an appropriate amount of flexion (Figure 2). Failure to sufficiently accommodate a hip flexion contracture can compromise the patient’s function during standing and ambulation (Figures 3 and 4). During standing, an unaccommodated hip flexion contracture may prevent the patient from standing straight, compromising the patient’s balance (Figure 5). Additionally, an unaccommodated hip flexion contracture can cause excessive lumbar lordosis, compromising the structural integrity of the patient’s spinal column (Figure 4).
During ambulation, an unaccommodated hip flexion contracture can cause an excessively asymmetrical gait pattern.

E. Bench Alignment
The Plié® 3 MPC Knee should be in a fully extended position during stance phase for level ground ambulation. An inherently stable trochanter-knee-ankle (TKA) alignment is essential to a successful user outcome with the Plié MPC Knee. A plumbline dropped from the trochanter reference point on the lateral socket should fall at or up to 5mm anterior to the knee joint axis (Figure 5). Align the foot as recommended by the foot manufacturer. An inherently unstable trochanter-knee-ankle (TKA) alignment can cause a rapid extension moment at the knee joint after mid stance. The non-adjustable stance extension resistance could 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 3 MPC Knee may differ from other knee joints. Consequently, if a new socket is not fabricated for use with a Plié 3 MPC Knee, the socket attachment component may require re-lamination to the socket to achieve the recommended alignment

F. Static Alignment

• Instruct the user to stand between parallel bars.
• With equal weight on each limb, adjust the height of the prosthesis as necessary.
• Ensure the trochanter-knee-ankle (TKA) alignment follows the recommendations of inherent stability.
• 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.

G. Dynamic Alignment

• 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.
• Instruct the user to carefully ambulate. Teach the user to flex the ipsilateral hip extensor muscles at initial contact to stabilize the knee joint.
• Train the user to load the prosthetic toe to initiate the swing phase transition.
• Train the user to take steps of equal length.
• Adjust the alignment in the transverse, coronal and sagittal planes as necessary.

H. Plie Control 6

The Plie Control 6 software is required to program a Plié 3 MPC Knee. Download software from the following website to install the program at https://www.pliesupport.com/download. This software is for use by prosthetists to program the knee. This software should not be used by the patient.

I. Plie 3 Setup
Thoroughly read and follow the instructions as stated in the Prosthetist Setup Guide and Plié Setup Wizard to set up and program the knee. Utilize the “Help” function in the Plie Control software to assist with issues that may arise.

J. Finishing Options
A discontinuous, two-piece cover is recommended for cosmetic finishing. Care should be taken to ensure that the battery compartment and manual adjustments are accessible.

DETECTION OF MALFUNCTIONS

If you notice any abnormal behavior or feel any changes in the characteristics of the device, or if the device has received a severe impact, consult your prosthetist.

WARNINGS, CONTRAINDICATIONS, AND SIDE EFFECTS

A. Warnings
Inappropriate use of the device, in relation to the recommendations of your prosthetist, can cause the degradation of parts of the device (carrying heavy loads for example, excessive stress, exceeding the service life, etc.). Never attempt to loosen the bolts affixing the pyramid connector. If unusual movement or product wear is detected in a structural part of a prosthesis at any time, immediately discontinue use of the device and consult a clinical specialist. Water resistant: The device is safe for occasional submersion in fresh water up to 1 m (3 ft) for up to 30 minutes. The device should not be used for bathing and should not be immersed in salt water or chlorinated water as these may cause corrosion. Failure to follow the safety precautions can result in device malfunctioning and risk injury to the user.

B. Contraindications
The device is inappropriate for users with:

• insufficient hip joint or pelvic voluntary muscle control
• insufficient cognitive ability to charge the batteries and care for the device

C. Side effects

There are no known negative side effects. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority.

MAINTENANCE, STORAGE, DISPOSAL, AND DURABILITY

A. Maintenance / Cleaning

• No maintenance operation such as lubrication, work on the screws, or other parts is required.
• Inspect the device every six months. If the user is more active, more frequent inspection may be necessary. Service as necessary. After use in water:
  • Dry the knee with a towel once out of the water
• If the device is sprayed by, or accidentally submerged in, salt water or chlorinated water immediately rinse with fresh water and allow to dry.
• The device may be cleaned with mild soap and warm water.

B. Storage

• Battery temperature range for charging: 0°C to 45°C (32°F to 113°F)
• Storage and shipping 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 pressure range: 500 hPa to 1060 hPa (7.3 psi to 15.4 psi)
• Water and Dust Resistance: Rated to IP67 per IEC 60529 (Protected against dust and the effect of submersion in water up to 1m for 30 minutes)

C. Disposal
The different items of the device are special wastes and must be handled according to local laws.

D. Technical Support
For Technical Support in the USA, please contact PROTEOR USA toll-free at 1-855-450-7300. For Technical Support in the EU, please contact PROTEOR France at +33 3 80 78 42 08.

E. Warranty and Service
The Plié® 3 MPC Knee purchase includes a 36-month warranty covering all manufacturer defects effective only if the product is used according to manufacturer recommendations. The batteries, battery charger, and accessories are provided with a 12-month warranty. An extended warranty is available. See product catalog for details.

F. Service and Repair

For the warranty to remain in effect, the knee must be serviced 12 and 24 months after purchase. For knee service or repair, please contact PROTEOR. A loaner knee will be provided upon request. For service and/or repair, please ship the knee in the provided shipping case to the following address:

PROTEOR USA
425 East 400 North (PO Box 50) Gunnison, UT 84634 USA Toll-free: 1-855-450-7300 [email protected]

PROTEOR France Rue du Cheffin 21250 Seurre France +33 3 80 78 42 08 [email protected] 

DESCRIPTION OF SYMBOLS

electronic equipment, which should not be

disposed of in regular wastes at the end of its usable life

REGULATORY INFORMATION

This product is tested and certified to comply with the MDR 2017/745 (EN 55011 Class B and EN60601-1 and EN60601-1-2), STSI EN 300-328 under R&TTE Directive 1999/5/EC and, ISO 10328 – P6 – 125 kg. The device complies with Part 15 of the FCC Rules and carries the CE mark

References

• Freedom Innovations | Plié Support
• Home - Proteor
• Spark Inspiration - Proteor USA
• Freedom Innovations Plié Support
• Freedom Innovations | Plié Support

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