Bauerfeind uniprox JT30 User manual

JT30
Swan Polycentric Knee Joint with
Hydraulics and flexible
Stance-Control
unique prosthetic solutions
A company of the Bauerfeind Group
Ein Unternehmen der Bauerfeind Gruppe –www.uniprox.de
Rev.2-2022-12_JT30
Quality and Function
Instruction Manual
Distributed by:
Uniprox GmbH & Co.KG, H.-Heine-Str.4, 07937 Zeulenroda-Triebes
Imasen Engineering Corporation
3-1-8 Techno Plaza Kakamigahara,
Gifu, 509-0109 Japan
MedNet EC-REP GmbH
Borkstrasse 10,
48163 Münster, Germany

Please read the IFU carefully before fitting. Comply with all instructions, especially
the safety instructions. Only a conscientious fitting guarantees the trouble free
function.
1. Intended Use
The knee joint JT30 is only suitable for prosthetic care of the lower extremities. It contains a
hydraulic swing phase control. Thanks to its special 5-axis geometry the JT30 allows a primary
diffraction up to 5 ° at heel strike with knee-save moving of the joint pivot point.
The JT30 prosthetic knee joint is intended for Mobility level 2 & 3 (according to MDS)
and is limited to a body weight of 125 kg.
Additional loads and patient activities must be taken into account when
calculating the load.
2. Technical data
Proximal connection: pyramid
Distal connection: pyramid
Included in delivery:
1 prosthetic knee joint with preassembled
extension assist spring („hard“) on the left side
Order No. Material Installation height Weight Flexion angle Article No.
JT30 Aluminum 164 mm 840 g 150° 4 610 060 00 00 000
3
2.1. Service parts for JT30
The spring-set contains springs in ‚hard‘ and ‚soft‘ for the right side of the joint and ‚soft‘
springs for the left side. So you can choose from six different options for setting the extension.
See Table 1:
3. Indications/ Contraindications
Indications:
•Transfemoral amputation
•Knee disarticulation
•Hip disarticulation
•Congenital limb deficiency
Contraindications:
•The patient is over 125 kg (275 lbs) and/or has a mobility level of 1 or 4
•The doctor decides the prescription of the product is inappropriate.
4. Side effects
There are no known side effects.
Order No. Model Article No.
E-JT30-EFS Extension spring-set 4 610 069 00 00 000
Strength Left Side Right Side
1 (Soft) - -
2 soft spring -
3 (Factory setting) hard spring -
4 soft spring soft spring
5hard spring soft spring
6 (Hard) hard spring hard spring
The color of the spring cap
indicates the strenght of
the spring:
soft spring - white
hard spring - black
2

5. General safety instructions
•This medical device is designed for single patient, multiple use.
•Fitting/service of this medical device is only allowed by a certificated orthopedic
professional.
•The professional should instruct the correct use of the device to the user.
•The joint must be protected against dust, moisture, aggressive media, and mechanical
forces so its function is not affected.
•The joint is intended for use at temperatures from -10°C to 50°C.
•Do not longer use the knee joint if its function is impaired. This may be due to stiffness,
restricted extension, noise generation, faulty swing phase control or stance phase safety,
as well as impact from an external force (for example, if dropped). In such cases, it must
be checked by a professional and, if necessary, sent to Uniprox GmbH & Co.KG.
•There is a risk of jamming when the joint is in use.
•The product must not be changed or applied in any improper way. Non-compliance can
impair the function of the product and thus no liability will be accepted.
•The safety of the user is not guaranteed if the product is not used for its intended purpose.
This will also terminate the warranty of the product.
•Joint components may heat up slightly during walking.
•Silicone spray should be used to prevent noises being generated by contact between the
cosmetic foam and knee joint. Do not use Talcum powder as it removes lubricant from the
bearings and may lead to impaired function as a result.
•Avoid loading onto the prosthetic knee joint in the maximum flexed position.
•In case of maximum flexion, posterior part of the socket or other components may hit and
damage the knee device and the socket (Fig. 1-a). If it is inevitable, place a soft pad
between socket and the knee for shock reduction (Fig. 1-b) and make a new hitting point
to distal part of the knee to reduce moment force (Fig. 1-c).
•When the knee joint is bent, never put hands around the device.
•Insertion of fingers between knee components or the knee device and another prosthetic
component could cause severe injury such as laceration or fracture.
•This instruction should be given to users as well.
5
6. Construction and installation instructions
6.1 Static construction
The weight bearing line (load line) should run through the center of the front, top axis and the
lower connecting axis of the hydraulic cylinder (pic.2).
6.2 Dynamic adjustment
6.2.1 Adjustment of the axes position
To reduce the knee safety, the JT30
can be tilted forward. So the initial
rotation point moves anteriorly and
the knee can be bent easily.
At the same time the bouncing effect
is reduced. (pic. 3A)
To increase the knee safety the JT30
can be tilted backwards. So the initial
rotation point is located more posteriorly.
Therefore it becomes harder to bend the joint.
The bouncing-effect increases. (pic. 3B)
weight bearing line
front upper axis
lower axis of the hydraulic
cylinder
weight bearing line
4

6.2.2 Adjusting the flexible stance control (bouncing)
In addition, the bouncing buffer can be adjusted. First open the locking screw on the right side
(pic.4A) with a 2 mm Allen key. By screwing in the rear screw clockwise with a 4 mm Allen key,
you increase the bouncing resistance. (pic.4B) Then secure the bouncing buffer setting by
tightening the locking screw. (pic. 4C)
6.2.3 Adjustment of the hydraulic swing phase
Only the flexion in the hydraulic system can be
adjusted. Please rotate the hydraulic housing with
the knurled ring. A counter-clockwise rotation
Increases the flexion, clockwise on the other hand,
reduces the flexion. The maximum adjustment is
1 1/4 turns. Upon delivery the JT30 is adjusted to
minimum resistance (pic. 5).
Due to the polycentric structure an additional
damping of the extension is not necessary. The
pendulum motion of the lower leg can be adjusted
via the extension springs. At higher walking
speeds, a higher flexion resistance is required.
The extension spring can impede the pendulum
movement and should be removed during fast
running style.
67
reduce
flexion
resistance
increase
flexion
resistance
②
①④
6.2.4 Adjustment of the springs
To remove the springs please turn the screw out in the center of the spring. Prevent a sudden
uncontrolled movement of the spring by some pressure on the wound spring area from
posterior to anterior. Please note that the color of the plastic sleeve corresponds to the spring
strength.
Apply some grease on all contact surfaces of the spring and plastic parts. Now insert the
plastic sleeve with the screw from outside in the spring. Push the disc on the inside on the
screw and then insert the angled ends into the provided holes of the joint. Press the spring in
the wound area towards anterior to make sure that the spring can be screwed using the hole
intended. In the final installation, the screw must be secured with Loctite.
7. Maintenance and Cleaning
The function of the JT30 must be checked at regular intervals not exceeding 12 months. The
extension spring must be cleaned and all moving and sliding areas must be greased.
•Compressed air up to 2 bar can be used for cleaning.
•Do not use any aggressive cleansers.
In case of defects please return the knee joint to the Uniprox customer service for inspection or
repair.
8. 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 Imasen Engineering Corporation
as well as to the competence European Authority.
9. Warranty an Guarantee
Depending on the degree of usage, the knee joints can generally be used for 5 years with
regular maintenance.
Warranty is provided as stated in the terms of sale and supply (T &C) of Uniprox GmbH & Co.
KG provided that the above conditions are met.
10. Storage and Disposal
This product has no special storage regulations.
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: [e-mail]