PROTEOR 1P130 / 1P130-KD 1P131 / 1P131-KD HYTREK Instruction Manual

1P130 / 1P130-KD 1P131 / 1P131-KD HYTREK
Instruction Manual

Please read before use in the presence of your Prosthetist/Orthotist

COMPONENTS INCLUDED

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

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
[email protected] – www.proteor.com

References

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