uniprox JT40 User manual

JT40
Dolphin Monocentric Knee
Joint with Hydraulics
unique prosthetic solutions
A company of the Bauerfeind Group
Ein Unternehmen der Bauerfeind Gruppe –www.uniprox.de
Rev.1-2022-12_JT40
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. Only correct usage will warrant the
function.
1. Intended Use
The knee joint JT40 is only suitable for prosthetic care of the lower extremities. The JT40
contains an effective hydraulic swing phase control. The back shifted pivot point ensures the
safety in the stance phase. The knee joint is intended for Mobility level 3 and 4 and is limited
to a body weight of max 100 kg.
Additional loads and patient activities must be taken into account when
calculating the load.
2. Technical Data
Proximal connection: pyramid
Distal connection: 30 mm Tube clamp
3. Indications/ Contraindications
Indications:
•Transfemoral amputation
•Knee disarticulation
•Hip disarticulation
•Congenital limb deficiency
Contraindications:
•The patient is over 100 kg (220 lbs) and/or mobility level 1-2
•The doctor decides the prescription of the product is inappropriate.
4. Side effects
There are no known side effects.
Order
No.
Material Installation height Weight Flexion angle Article No.
JT40 Aluminum 140 mm 496 g 170° 4 610 070 00 00 000
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5. General 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, make a new hitting
point on the distal part of the knee to reduce moment force (Fig. 1-b).
•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.
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6. Construction and assembly instructions
6.1 Static construction
The load line should run 10 –15 mm before
the middle of the knee joint axis. (pic. 1).
The screw of the tube clamp must be
tightened with 8 Nm.
Note:
Make sure that the socket has no contact with
The knee joint during the maximum flexion or
Otherwise protect them against damage.
6.2 Dynamic adjustment
6.2.1 Adjustment of the flexion
To change the flexion resistance
of the hydraulic turn the hydraulic
cylinder in the desired direction.
The turning clockwise reduces the
resistance; the turning counter-
clockwise increases the resistance.
The hydraulic cylinder can be turned
maximal 2 full turns.
Increase the
flexion resistance
reduce the flexion
resistance
10～15mm
(pic. 1)
weight
bearing line
6.2.2 Adjustment of the extension resistance
The adjustment of the extension resistance is made
over the socket screw, on the top suspending of the
piston rod which is on the backside of the knee joint,
with a 2 mm-Allen key. The turning clockwise
increases the extension resistance, unscrewing
counterclockwise reduces the extension resistance.
7. Cleaning and maintenance instructions
The function of the prosthetic knee joint must be checked at regular intervals of no more than
12 months.
The JT40 can be cleaned with compressed-air (2bar).
Do not use any aggressive cleaner.
In case of failure please send the knee joint to our Uniprox customer service for inspection and
reparation.
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]
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