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  9. uniprox JT06 User manual

uniprox JT06 User manual

JT06 Weight activated
brake knee manual lock
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – www.uniprox.de
Rev.2 2021 12_JT06
Qualität und Funktion
Gebrauchsanweisung
Instruction Manual
Distributed by:
Uniprox GmbH & Co.KG, H. Heine Str.4, 07937 Zeulenroda Triebes
ST&G USA Corp.
2691 Saturn Street
Brea, CA 92821, USA
MDSS GmbH
Schiffsgraben 41
30175 Hannover, Germany
2 3
Please read the I U carefully before fitting. Only correct usage will
warrant the function.
1. Intended Use
The JT06 Weight activated brake knee is designed for prosthetic limb users in the K1
and K2 activity scales with a maximum body weight of 125 kg. The knee joint has a
manual knee lock that can be used locked or un locked depending the rehabilitation
and activity development of the user.
2. Technical data
Materials: Aluminum Alloy, Stainless Steel, Steel,
Urethane
Tube clamp: Ø 30 mm
Tube clamp torque setting: 16 Nm
Operating /Storage Temperature Range: 10°C to 50°C
3. Indication/ Contraindication
Indications:
•Amputation of lower extremities
•Activity for K1 up to K2
•Weightlimit < 125 kg
Contraindications:
•Residual muscular weakness, contractures or proprioceptive dysfunction including
poor balance
•Inability to comprehend instructions
•Contra lateral joint instabilities or pathology
•Complicated conditions involving multiple disabilities
4. Side effects
Not known.
Order No. Installation height above
the axix center /
complete
Weight lexion
angle
Article No.
JT06 26 mm / 65 mm 495 g 145° 4 610 130 00 12 000
- English -
5. General safety instructions
•The medical device is designed for multiple use to a single patient.
•Fitting/service of the medical devise is only allowed by a certificated orthopedic
professional.
•Be aware of additional weight that the user is carrying often, as this weight needs
to be added to the users weight.
•The professional should instruct the correct use of the devise to the user.
•Be aware of finger trap hazard at all times.
•Any changes in performance of the knee e.g. inability to engage manual lock
mechanism, instability or lag in transition from flexion moment to full knee
extension moment in the knee, or unusual noise should be immediately reported
to the Clinician / Practitioner.
•Any excessive changes in heel height may adversely affect the stability of the knee.
•The user should be advised to contact their Clinician / Practitioner if their
condition changes.
•Avoid abrasive environments such as those containing dust or sand for example as
these may promote premature wear. Avoid contact with talcum powder.
•Operating & Storage Temperature Range: 10°C to 50°C (14°F to 122°F)
•Knee is not waterproof – do not submerge in water or prolonged exposure to salt
or chlorinated water environment! These types of exposure will cause corrosion
and can void warranty.
- English -
4 5
6. Alignment and Set-Up
Alignment for the L1311A should be adhered
to so as to enable a stable and safe functioning
prosthesis for the wearer. The recommended alignment is 10mm anterior
to the Knee Center which will have the weight line on
the centerline along the length of the pylon.
Weight line should also be along the centerline of the
Pylon in the sagittal plane so as to not promote undue
stress on the knee joint axis.
Important: If the weight line is too close to the knee
center, there is possibility of inadvertent knee
instability. Adhere to allowance for safety factor of at
least 3mm for initial fitting, and to reassess knee
alignment and function on a regular basis initially
(especially for new amputees) so as to gauge their
progression and ability with the need for fine tuning
knee function!
Do not insert any tube spacers into tube clamp section – This can lead to
potential failure. Only the intended pylon should be fully inserted to the
tube clamp bottom. Be sure that the 5mm Hex Wrench Tube Clamp Pinch Bolt torque is
set to 16Nm.
7. Adjustment
The knee joint is supplied by the factory in the basic setting. Carefully assess the brake
function with the wearer during the dynamic initial fitting to see if the basic setting is
optimal.
If adjustment is necessary, it is best to start with the Stance Phase adjustment and
then go to Swing Phase adjustments.
NOTE: There is a fine balance to adjusting this so as to ensure that the wearer will have
a smooth transition to swing. Overly adjusting will cause the knee to not release
during swing initiation!
- English -
7.1 STANCE PHASE –
Brake Sensitivity Stance Adjustment
The brake sensitivity adjustment is to fine tune the
amount of load required during stance phase to
activate the brake mechanism.
(See the image for the position of the brake set
screw).
To set the adjustment screw, flex the knee joint and
use a 4mm hex wrench:
•Clockwise adjustment = more weight is needed to
trigger the brake function
•Anti Clockwise adjustment = less weight is
needed to trigger the brake function
NOTE: Adjustment as little as 5 degree turn makes a
notable difference!
Resetting Brake sensitivity to factory setting: Brake
sensitivity adjustment screw head should be flush
with the knee brake mechanism surface.
7.2 SWING PHASE –
riction Adjustment
The Knee Friction Adjustment screw is located
towards the bottom of the knee joint on the anterior
and can be adjusted with a 3mm hex wrench:
•Clockwise adjustment = increased friction (more
resistance in the swing phase)
•Anti Clockwise = decreased friction (smoother to
free swingphase)
NOTE: Minor adjustments of as little as 3 degree turn
will provide a notable difference!
The knee friction effect may occur anyway during
initial swing (prosthesis sticks) depending on the
user’s weight or walking habits which could impair
the safety and the user’s walking behavior.
- English -
4 7
Reassess knee function during walking and adjust accordingly.
Important: flexion and extension must be possible at all settings!
Resetting Friction to factory setting: Friction adjustment screw should be reset to be
flush with knee frame surface.
7.3 SWING PHASE – Spring Extension Assist
The Knee Spring Extension Adjustment screw is located
Within the tube clamp portion of the knee joint and is
adjusted with with a 5 mm hex wrench :
•Clockwise adjustment = increases extension assist
•Anti Clockwise adjustment =
decreases extesion assist
Important: Knee action should be smooth. This knee is
a low activity knee, so do not expect for very rapid
extension assist to occur. Excessive spring tension could
possibly affect knee friction tension.
7.4 Unlocked Knee Mode –
Manual Lock Disable Procedure
Note: Lock should only be disabled by the prosthetist when patient has been released
to have the ability to control the prosthesis without the need for the manual lock
mechanism!
Manual Lock Disable:
•Push the locking lever (a) upwards and secure in
this position by turning the set screw (b) with a
2 mm hex wrench clockwise. Apply thread locker!
•Lanyard can be removed by removing the retainer
screw with 2.5mm hex wrench.
IMPORTANT: Set screw (b) should be tightened to a torque of 5 Nm and
secured with thread locker when finishing the prosthesis. Do not over
tighten! Use a torque wrench!
- English -
Note: Failure to adequately secure the set screw (b) when disabling the locking lever
(a), can result in loss of function of the knee and / or makes it impossible to move the
knee freely.
Note: If being used with the locking function, the disable set screw (b) must not
impede the function of the locking lever (a) and must be secured with Loctite to rule
out inadvertent loosening and inadvertent function.
7.5 The Lanyard Handle
The Lanyard Handle has the ability to keep the knee in either the temporary unlocked
or locked position.
Setting the Lanyard Handle on the Cable:
Once the retainer screw is mounted with the star nut on
the socket, adjust the cable to the in desired length:
•Set the lanyard length by having knee in locked position
and handle in the locked position.
•Take out unwanted slack in the lanyard cable by pushing
excess length out of the handle, and remove ferrule by
unscrewing but do not remove handle.
•Mark cable as indicated.
•Cut cable at a 45 degree angle as indicated.
•Screw ferrule onto cable.
•Confirm lock function by cycling the lanyard handle to assess that the knee locks,
and unlocks. Adjust length as needed by screwing ferrule more onto the cable and
cut excess.
•If used with the locking function, the locking lever or lanyard cable must not be
impeded by the cosmesis. The cable must run freely.
IMPORTANT! Secure the cable so that it cannot catch in grinding tools
when modifications are required to socket! Hazard potential!
7.6 Attachment of Star Nut
The Star Nut needs to be laminated into the socket. For attachment an M4 thread
should be drilled into the button.
- English -
8 9
8. Maintenance and Cleaning
The Maintenance must be carried out by qualified personnel. Bi Annual inspection is
recommended. Check for visual defects that may affect proper function.
Use a damp cloth and mild soap to clean the outside surfaces.
DO NOT use aggressive cleaning agents or lubricants.
If the knee comes into contact with salt or chlorinated water, or bodily fluids, it should
be rinsed with fresh water and dried.
9. CE- Conformity
The product satisfies the requirements of Regulation (EU) 2017/745 of the European
Parliament and of the Council (MDR) and bears the CE mark. All major incidents related
to the product needs to be informed to Uniprox and/or ST&G USA Corp. as well as to the
competence European Authority.
10. Warranty
Warranty is provided under the terms of sale and supply of Uniprox GmbH & Co. KG
provided that the above conditions are met.
11. Disposal
The product is disposable with standard household garbage.
Please direct any questions to:
Customer Service: + 49 (0) 36628 66 33 70
Fax: + 49 (0) 36628 66 33 77
E mail: [email protected]
- English -

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