PROTEOR 1P650 Easy Ride Knee Instruction Manual

EASY RIDE
1P650
PROFESSIONAL

Instruction for use

1P650 Easy Ride Knee

****| EASY RIDE – 1P650 Instructions for use for Prosthetists/Orthotists
Please read before using or working on the device| 1P65099
2021-04
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It is important to read and explain the patient information leaflet to the patient.

COMPONENTS INCLUDED

DESCRIPTION, PROPERTIES AND MECHANISM OF ACTION

A. Description
A single-axis, multi-sport knee that can withstand high impacts, fitted with a state-of-the-art air/oil shock absorber, a distal connector and a proximal connector that can rotate.
The wearer can easily modify the knee position and settings to adapt it to the type of activity to be performed: SLIDING or BIKING
Male pyramid adapters provide its proximal and distal connection. These pyramids are designed to connect to a female pyramid. The male pyramids provided can be replaced by female pyramids, which can be ordered separately.
B. Properties

This device has undergone a one-million-cycle test, in accordance with the conditions described in standard NF EN ISO 10328 at a P6 load level (i.e. 125 kg). The service life depends on the activity performed and on how often and how intensively it is used by the patient.

INTENDED USERS/INDICATIONS

This medical device is supplied to healthcare professionals (prosthetists/orthotics) who then instruct the patient on how to use it. The prescription is drawn up by a doctor. The doctor works with a prosthetist/orthotist to assess whether the patient is suited to using the device.
** This device should be used on ONE PATIENT ONLY. It must not be reused on other patients.
INSTRUCTIONS FOR USE
** This device is exclusively intended to be used as prosthetic equipment by amputees wishing to engage in sports activities. It is specifically recommended for very active patients (L4) and allows them to practice sports such as surfing, snowboarding, cycling, mountain biking, roller skating, ice skating, and paddleboarding.
This device is not intended to be used for walking.
Maximum weight (including carried load): 125 kg Not suitable for children.

CLINICAL BENEFITS

The device allows:

• The patient is to practice many summer and winter sports (road cycling, skateboarding, surfing, snowboarding, etc.)
• Adjustment of the degree of shock absorption both in flexion and extension
• Adjustment of the resistance to flexion and of the extension assist force (by inflating the pneumatic system)
• Customization to different sports by changing the position of the pin which secures one end of the shock absorber.

ACCESSORIES AND COMPATIBILITIES

1K173 or 1K176
1K177 (max. weight 100 kg)
Connectors| 1K172 or 1K207-HD
Distal adapter| Tube and connector| 1G01-HD+ 1041HD
1D52-P6

ASSEMBLY AND FITTING TO THE PATIENT

A. Aligning
Preparation:
Mark the load lines and the center of the knee joint (with the patient standing and the knee fully extended).

Sliding position (e.g. for board sports, skiing, etc.):
Sagittal plane:
Mount the knee on the socket with slight flexion, such that the load line through the center of the hip joint is about 3 cm (depending on the activity) to the rear of the knee’s upper front pin and passes through the metatarsophalangeal joint of the foot.
The heel may lift off the ground.
Frontal plane:
Mount the knee in line with the socket.
Mount the leg section with an adduction angle of about 10° with respect to the knee (depending on the activity).
The load line through the center of the hip joint passes through the medial edge of the foot (depending on the activity).
Biking position:
Sagittal plane:
Mount the knee such that its axis is in line with the axis of the socket.
The load line must pass through the center of the hip joint, the center of the socket, and the rear of the axis of rotation of the knee.
The load line passes through the posterior of the foot, 1/3rd of its length from the back of the foot (depending on the alignment recommendations for the foot).
Frontal plane:
Mount the knee such that its axis is in line with the axis of the socket.
The load line passes through the center of the knee and the center of the foot.
An internal rotation of the leg segment may be necessary.
Note: These alignment recommendations draw on the results of laboratory tests and trials. When the patient is practicing a sport, these theoretical alignments can be modified so long as the setup of the device complies with the rules regarding safety and the rules applicable to the correct use of the device on the type of equipment used. The patient’s safety and comfort depend on them.
B. Change of position setting
To switch between the SLIDING (for sports performed on a board, skis, skates, etc.) and BIKING positions, move the pin that secures the upper end of the shock absorber from position 1 to position 2, as follows:

• Unscrew the two screws at the two ends of the pin using the two Torx T30 keys supplied.
• Remove the pin using the pin-removing tool supplied.
• Insert the pin in the desired position.
• Refit the two screws with their washers, apply a drop of XC048 low-strength thread-locking compound, and tighten the screws to a torque of 6 Nm.

SLIDING position
BIKING position

The screws must be tightened and untightened with a torque wrench fitted with a Torx T30 bit.
If the screw head becomes deformed, replace the screw with one of the two spares supplied.
** The maximum flexion stops in the BIKING position are only present to protect the shock absorber; they must not under any circumstances be subjected to stresses regularly and repeatedly.
C. Selecting the position and settings for different activities**
The shock-absorber fitted offers three setting controls:

• BLUE control (FIRM / MEDIUM / OPEN) sets the compression speed to slow, medium, and fast respectively.
• BLACK control (ADJUSTING TRAIL MODE) is used to fine-tune the compression speed, in OPEN mode only, with 3 positions available: 1, 2, and 3 from soft to firm.
• RED control (REBOUND) sets the extension speed.

D. Adjusting shock-absorber pressure
Using the pump provided, pressurize the shock absorber to the required pressure.
If the pressure is too high, reduce it using the air release button on the pump.
Only used the pump supplied or a pump fitted with a 20-bar gauge suitable for FOX shocks.
The combinations of positions and settings indicated below are provided as a guide only and may vary as a function of the activities performed and the patient’s weight:
Sporting activities:

1. Pin position:
   • BIKING: road cycling, cross-country MTB, downhill MTB and motocross
   • SLIDING: all other activities (on a board, skis, skates, etc.)

2. Flexion settings:
   • OPEN (blue control)

3. Extension settings:
   • REBOUND generally set to maximum and adjusted as required (red control)

4. Pressure:
   • 0 bar: Road cycling, cross country MTB
   • 1 to 3 bars: Surfing, paddleboarding, waterskiing, wakeboarding
   • 4 to 6 bars: Downhill MTB, snowboarding, piste skiing
   • 5 to 10 bars: Fitness training, racket sports, combat sports, motocross
   The air pressure in the shock absorber must never exceed 20.6 bars.
   It is essential to release all the air from the shock absorber when traveling at high altitudes (e.g. in an airplane).
   **** Refit the cap to the valve after adjusting the air pressure.

Moving between activities/getting past obstacles/need for safety:

1. Flexion setting:
   • FIRM (blue control)

DETECTING ANY MALFUNCTIONING

If you notice that the device is behaving abnormally or if its characteristics feel different, or if it has been badly knocked, consult your prosthetist/orthotist.

WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS

A. Warnings
When using the knee again after a period of inactivity, traces of oil may appear. Wipe them away with a soft cloth.
The shock absorber has been prepared specifically for use as part of the knee and must not under any circumstances be disassembled or used for any other purpose.
Leave the shock absorber to cool down after use; be aware that it may be hot enough to burn skin.
If the temperature of the shock-absorber changes significantly its behavior may vary.
The shock absorber is unpressurized when delivered to eliminate any problems while in transit.
It is possible to trap a finger or pinch clothing in the knee joint. To avoid any injury caused by the movement of the joint, make sure that no one’s hand or fingers is near the mechanism.
B. Contraindications
Never lubricate the knee pins; this can cause them to degrade rapidly.
If a load is being carried, the operation of the knee may be disrupted.
The warranty does not cover damage or degradation caused by misuse, unsuitable alignment, use in an unsuitable environment, or any other inappropriate use.
If a malfunction occurs or if premature wear or traces of rust are detected, consult your prosthetist/orthotist as soon as possible
Never leave this device near a source of heat since it might burn or release toxic fumes.
The use of solvents is prohibited.
C. Side effects
There are no side effects directly associated with the device.
Any serious incident that occurs which relates to the device must be reported to the manufacturer and to the competent authority of the member state in which the incident occurred.

MAINTENANCE, STORAGE, DISPOSAL, AND SERVICE LIFE

A. Maintenance/cleaning
Check regularly the condition of the maximum flexion stop screws
Check regularly that the M6 screws are tight (tightening torque of 6 Nm).
If a malfunction occurs or if premature wear or traces of rust are detected, consult your prosthetist/orthotist as soon as possible
You can clean the knee using a damp sponge
Clean the knee after exposing it to potential contamination (water, mud, etc.) and if it is immersed.
After immersion in seawater, rinse carefully in fresh water and then dry completely.
Do not use a solvent or other aggressive product when cleaning
To clean the shock absorber, refer to the manufacturer’s instructions provided with the knee.

B. Fitting the spare components in the covers kit
As part of the normal and expected use of the EASY RIDE sports knee, certain parts may age more quickly than others, depending on the activities performed. PROTECTOR provides replacements for the most exposed parts in a covers kit (1P653) consisting of:

• Right shell (x1)
• Upper shell (x1)
• Left shell (x1)
• M3 washers (x8)
• M3x8 screws (x8)

The parts are assembled as described below:

1. Remove the eight M3x8* screws using a 2 mm Allen key, then detach the three shells (you may need to apply some solvent, such as acetone).
   

2. Clean any glue residues off the surfaces of the side frames and upper plate.

3. Degrease the surfaces to be bonded using a dry solvent (aluminum surfaces and covers), then coat one of the two surfaces with cyanoacrylate adhesive (Ref. XC053) (a single line of adhesive following the outline of the surface to be bonded is generally sufficient).

4. Position the covers and apply uniform pressure for at least 3 minutes.
   **** Once the two surfaces are in contact, do not try to move or reposition the parts in any way.

5. Fit the eight washers and the eight screws provided and apply XC047 medium-strength thread-locking compound. Tighten to a torque of 0.25 Nm
   The screws must be tightened using a torque wrench fitted with a 2 mm hex head bit.
   After bonding a cover, the knee must be left to dry for at least 24 h before use.

C. Storage
** Service and storage temperature: -25°C to +40°C
Relative humidity of the air: no restrictions
D. Disposal
The various components of this device are considered as special waste: aluminum, stainless steel pins, screws, titanium connectors, plastic bushes, and oil. They must be treated in accordance with current, applicable legislation.
E. Service life**
The knee must be serviced after every 100 hours of use by your prosthetist/orthotist (i.e. every year if used at moderate activity levels or every 6 months at a higher level of activity).

DESCRIPTION OF THE SYMBOLS

| Manufacturer| | Identified risk| ****| CE marking and year of first declaration of conformity
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REGULATORY INFORMATION

**** This product is a CE-marked medical device that is certified as conforming with regulation (EU) 2017/745

NAME AND ADDRESS OF MANUFACTURER

PROTECTOR SAS
6 rue de la Redoute – 21850
Saint-Apollinaire – France
Tel.: +33 3 80 78 42 42 –
Fax: +33 3 80 78 42 15
[email protected]
www.proteor.com

Documents / Resources

| PROTEOR 1P650 Easy Ride Knee [pdf] Instruction Manual
1P650 Easy Ride Knee, 1P650, Easy Ride Knee, Ride Knee, Knee
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References

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