PROTEOR 1P130 / 1P130-KD 1P131 / 1P131-KD HYTREK Instruction Manual
- June 4, 2024
- PROTEOR
Table of Contents
- COMPONENTS INCLUDED
- **DESCRIPTION, PROPERTIES AND MECHANISM OF ACTION
- PRESSING A SECOND TIME ON THE BUTTON UNLOCKS THE KNEE. INTENDED
- CLINICAL BENEFITS
- OPERATION/INSTRUCTIONS FOR USE
- DETECTING ANY MALFUNCTIONING
- WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS
- MAINTENANCE, STORAGE, DISPOSAL, AND SERVICE LIFE
- DESCRIPTION OF THE SYMBOLS
- REGULATORY INFORMATION
- NAME AND ADDRESS OF MANUFACTURER
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
1P130 / 1P130-KD 1P131 / 1P131-KD HYTREK
Instruction Manual
Please read before use in the presence of your Prosthetist/Orthotist
COMPONENTS INCLUDED
Designation | Ref. | Included/Sold separately |
---|---|---|
Knee | 1P130(-KD) or 1P131(-KD) | Included |
Protective hood | 1P13055 | Included |
2.5 mm Allen (hex) key | WKF026 | Included |
Cover | 1P13029-B/-N |
1P13028-B/-N
1P13027-B/-N| Included
One-part cosmetic cover| 1G16| Sold separately
**DESCRIPTION, PROPERTIES AND MECHANISM OF ACTION
**
A. Description
A single-axis knee offering hydraulic regulation of the stance and swing
phases, fitted with a manual lock that halts the flexion of the knee.
It is available in four different versions:
- 1P130/1P131: Male pyramid proximal connector, suitable for patients who have had a transfemoral amputation or hip disarticulation
- 1P130-KD/1P131-KD: Threaded proximal connector (M36×1.5), suitable for patients with a long transfemoral amputation stump or who have had a knee disarticulation For all 4 versions, the distal connection is made via a Ø34 mm tube
B. Properties
Ref. | 1P130 | 1P131 | 1P130-KD | 1P131-KD |
---|---|---|---|---|
Colour | Blue | Black | Blue | Black |
Weight | 1265 g | 1285 g | ||
Maximum flexion | 120° | |||
Maximum patient weight (Including carried load) | 150 kg |
This device has undergone a three-million-cycle test, in accordance with standard NF EN ISO 10328 at a P7 load level (i.e. 150 kg), which corresponds to a service life of 4 to 5 years, depending on the patient’s mobility level.
C. Mechanism of action
The knee contains an oil-filled hydraulic cylinder.
The hydraulic system and the control of its operation provide safe management
of the stance phase (transition after the swing phase and resistance to
flexion) and the swing phase (impact at the end of extension and dampening of
flexion).
The angle of flexion of the knee is limited mechanically to 120°. This
amplitude lets the patient kneel down and ride a bicycle.
It offers four separate adjustments, an extension assist, and a system for locking the flexion.
The knee’s intrinsic characteristics (flexion, braking, hydraulic regulation)
allow patients to negotiate slopes and stairs using alternating feet. As a
precautionary measure, it is advisable to hold on to the handrail when walking
downstairs.
The braking torque when descending stairs is high (150 Nm) up to a significant
flexion angle (75°). This torque gradually reduces as the flexion angle
reduces.
Simply by pressing a flexion locking button, the knee can be locked to prevent
any flexion. With regard to extension, the lock halts the flexion and allows
the knee to extend. The patient can thus lock the knee to make it easier to
negotiate obstacles, stand without tiring and perform activities safely (e.g.
climbing up a ladder).
PRESSING A SECOND TIME ON THE BUTTON UNLOCKS THE KNEE. INTENDED
USERS/INDICATIONS
This medical device is supplied to healthcare professionals
(prosthetists/orthotists) 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.
This device is exclusively intended to be used as prosthetic equipment for patients who have undergone transfemoral amputation, hip disarticulation or knee disarticulation. It is specifically recommended for active to very active patients (L3/L4) as it allows them to carry out their everyday activities on all types of terrain as well as negotiate slopes and stairs.
Maximum weight (including carried load): 150 kg
Not suitable for children.
The maximum flexion of the knee is 120°. This flexion may, however, be limited by the volume of the socket or by the cosmetic covering.
CLINICAL BENEFITS
The device allows:
- The patient to walk down stairs and slopes by bearing weight on the amputated leg to limit the effort on the sound leg.
- The knee is to be locked in flexion using a manual lock to allow certain activities to be performed safely (e.g. climbing a ladder).
- The prosthetist/orthotist adjusts certain settings to adapt the knee to the patient.
- Walking at different speeds thanks to hydraulic regulation.
- The hip to do less work since some of the knee extension force is provided by an extension assist spring.
OPERATION/INSTRUCTIONS FOR USE
A. Use in Lock mode
The knee is fitted with a lock which can be activated when you are standing or
sitting. It prevents all knee flexion and is useful when climbing a ladder,
for example.
To lock the knee, press the button at the rear of the knee.
Always check that the lock has been engaged before applying load to the knee.
Press the button next to the lock button to unlock the knee.
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
Caution, a knee with an electronic braking mechanism does not behave like a
braked knee; the patient may need some time to get used to a new knee when
switching between the two.
To reduce the risk of falling when going downstairs, it is advisable to hold
on to the handrail.
If the knee is not used for a few hours, it may make a clicking or cracking
noise when first used. This does not impair its operation.
So as not to damage the knee, do not apply talcum powder to eliminate rubbing
noises – use silicon spray instead. Talc degrades the mechanical components,
which might cause a malfunction and possibly a fall.
PROTECTOR disclaims all liability if talcum powder is used.
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 are near the mechanism.
If the knee is immobilized for a prolonged period is very cold conditions
(<10°C), the hydraulic system will not return to normal operation until the
patient has completed a few steps. Walk carefully until it feels normal again.
The knee is resistant to bad weather but needs to be dried if it does get
wet.
B. Contraindications
Your knee has been set up by your prosthetist/orthotist; you must not change
these adjustments, since this might result in a fall or lead to a serious
malfunction of the knee.
The following are strictly prohibited: removing the covers, screwing in, or
unscrewing any screws on the knee. If any play or looseness develops or your
knee starts to malfunction, please arrange to see your prosthetist/orthotist.
Never lubricate the knee pins; this might cause them to degrade rapidly.
The knee has been designed for patients with a maximum weight of 150 kg
(including carried load). If overloaded, a safety feature releases the
hydraulic system which can lead to rapid flexion of the knee.
If a load is being carried, the operation of the knee may be disrupted.
Particularly, the resistance when going down stairs may be insufficient, or
the knee may lock up suddenly.
If your weight increases significantly, arrange for your prosthetist/orthotist
to readjust the knee’s safety settings.
The warranty does not cover damage or degradation caused by misuse, unsuitable
alignment, use without suitable protection in a very dusty environment, or any
other inappropriate use.
The knee should not be exposed to environments that might induce corrosion of
the metal components (freshwater, seawater, chlorinated water, acids, etc.).
Showering or taking a bath while wearing the prosthesis is prohibited; this
might impair its properties and its correct operation.
Intensive use of the knee brake (e.g. due to a prolonged period of walking
down a slope or stairs) may cause the hydraulic system to overheat and the
braking effect to diminish. Do not touch the knee and reduce the activity
level to give the components time to cool down.
Never leave this device near a source of heat since it might burn or release
toxic fumes.
If used in very cold (<10°C) or very hot (>40°C) conditions the behavior of
the knee may change significantly. In this case, take precautions when walking
and going down slopes or stairs.
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
You can clean the knee using a damp sponge
Do not immerse the knee or hold it under running water
Dry your knee if it is exposed to bad weather (rain) or accidental splashing.
B. Storage
Service and storage temperature: -10°C to +40°C
Relative humidity of the air: no restrictions
C. Disposal
The various components of this device are considered special waste: elastomer,
plastic, aluminum, titanium, steel, brass, and oil.
They must be treated in accordance with current, applicable legislation.
D. Service life
It is advisable to arrange for a prosthetist/orthotist to check the product
once a year.
DESCRIPTION OF THE SYMBOLS
| Manufacturer| | Identified risk| 2
0
1
6| CE marking and year of the first declaration of conformity
---|---|---|---|---|---
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
cs@proteor.com –
www.proteor.com
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>