Avicenum ORTHO 2000 Knee Orthosis Medical Device Instruction Manual
- June 12, 2024
- Avicenum
Table of Contents
Avicenum ORTHO 2000 Knee Orthosis Medical Device
Product Information
- Product name: Avicenum ORTHO 2000 Knee orthosis type 01
- User profile: Avicenum ORTHO 2000 Knee orthosis type 01 is a medical device intended for use both at home and in medical care facilities.
- Intended use of the medical device: A medical device designed to support the knee during post-traumatic and post-operative therapy, prevent swelling, and serve as support for knee ligament and tendon laxity, inflammation, or injury.
- Target group: Patients with knee instability, post-operative and post-traumatic therapy of the knee, and patients with the above-mentioned indications. The knee orthosis is intended for use on healthy, intact skin. The orthosis is designed for all age groups and both genders. There are no restrictions for use during pregnancy.
- Side effects: Side effects may occur, especially if the knee orthosis does not fit properly or if it is worn when at rest. There may be bruising, impaired blood flow due to pressure on blood vessels, or impaired sensitivity due to a too-tightly-fitting knee orthosis. Sensitive and hypersensitive individuals may experience skin irritation (redness, itching, or blistering) at the place of contact of the knee orthosis with the skin.
Product Usage Instructions
- If you are using the knee orthosis for the first time, it is advisable to consult your attending doctor or have your health checked regularly by your doctor.
- In view of known contraindications, your attending doctor should evaluate possible risks and weigh them against the therapeutic benefits of using the medical device when considering the application of knee orthosis.
- How to choose the correct size of the knee orthosis:
- A proper fit is necessary to achieve the desired effect.
- Determine the size by measuring the circumference of the limb at the points indicated in the figure.
- If you are on the border between two sizes, choose the bigger one.
- If you are unsure of the size of your knee orthosis, visit a specialized medical supplies store or consult the manufacturer.
- If you have difficulties putting on the knee orthosis, visit a specialized medical supplies store and request a demonstration of the correct method of applying it.
- Note : Any swelling or instability of the knee should be assessed by a doctor. If this is the first time you have noticed swelling or instability of the knee, consult your doctor before using the knee orthosis. Do not start self-treatment with the knee orthosis unless you know the cause of the swelling or instability of the knee. Always consult your attending doctor before using this product in combination with other medical devices (such as compression stockings).
Dear customer,
you are holding a medical knee orthosis to support post-operative and post-
traumatic therapy. You can maximize the benefits of this product by its proper
use and maintenance.
Avicenum ORTHO 2000 Knee orthosis type 01 is made of 3D fabric. The materials used for its production are non-irritating and latex-free. On both sides, the orthosis integrates splints with a biaxial joint, which, in combination with the hook-and-loop fasteners, improves support and fixation of the knee joint. The mechanism of action of knee orthosis is based on the compression action and fixation in the knee area, which produces the necessary therapeutic effect. A proper fit is necessary to achieve the desired effect. For longer rest breaks, you should remove the orthosis unless otherwise directed by your attending doctor.
Product name:
Avicenum ORTHO 2000 Knee orthosis type 01
Product variants:
- double-sided, biaxial joint, size XS–XXL
User profile:
Avicenum ORTHO 2000 Knee orthosis type 01 is a medical device intended for use
both at home and in medical care facilities.
Intended use of the medical device:
A medical device designed to support the knee during post-traumatic and post-
ope-rative therapy, prevent swelling and serve as support for knee ligament
and tendon laxity, inflammation or injury.
Indications:
- acute or chronic instability of the knee
- follow-up treatment after severe or less severe knee distortions (sprains)
- post-traumatic swelling of the knee
- patellofemoral pain syndrome
- patellar chondropathy
- meniscopathies
- swelling of the knee in arthritis or arthrosis
- follow-up treatment after surgeries and fractures of the knee
- painful knee syndromes
- prevention of knee injuries
- instability of the ligamentous apparatus of the knee
If you are using the knee orthosis for the first time, it is advisable to consult your attending doctor or have your health checked regularly by your doctor.
Contraindications:
- skin diseases or injuries in the knee area
- acute weeping skin manifestations
- hypersensitivity to materials used
- lymphatic drainage disorders and non-specific soft tissue swelling in the knee area
- limb numbness disorders, peripheral neuropathy (e.g. in diabetes mellitus or varicose veins)
In view of known contraindications your attending doctor should evaluate possible risks and weigh them against the therapeutic benefits of use of medical device when considering application of the knee orthosis.
Target group:
Patients with knee instability, post-operative and post-traumatic therapy of the knee and patients with the above mentioned indications. The knee orthosis is intended for use on healthy, intact skin. The orthosis is designed for all age groups and both genders. There are no restrictions for use during pregnancy.
Side effects:
Side effects may occur, especially if the knee orthosis does not fit properly or if it is worn when at rest. There may be bruising, impaired blood flow due to pressure on blood vessels, or impaired sensitivity due to a too tightly fitting knee orthosis. Sensi-tive and hypersensitive individuals may experience skin irritation (redness, itching, or blistering) at the place of contact of the knee orthosis with the skin.
How to choose the correct size of the knee orthosis:
A proper fit is necessary to achieve the desired effect. Determine the size by measu-ring the circumference of the limb at the points indicated in the figure.
Note:
Any swelling or instability of the knee should be assessed by a doctor. If this is the first time you have noticed swelling or instability of the knee, consult your doctor before using the knee orthosis. Do not start self- treatment with the knee orthosis unless you know the cause of the swelling or instability of the knee. Always consult your attending doctor before using this product in combination with other medical devices (such as compression stockings).
- use a tape measure
- ask someone to help you
- measured values may change during the therapy – always verify the correct size before using a new knee orthosis
Measured 18 cm above the centre of the knee joint
XS| S| M
35 – 41| 41 – 47| 47 – 53
L| XL| XXL
53 – 60| 60 – 67| 67 – 74
If you are on the border between two sizes, choose the bigger one. If you are
unsure of your size of your knee orthosis, visit a specialised medical
supplies store or consult the manufacturer.
If you have difficulties putting on the knee orthosis, visit a specialised
medical supplies store and request a demonstration of the correct method of
applying it.
With the correctly selected size:
- you feel a noticeable but not uncomfortable pressure in the knee area
- the knee orthosis does not slip or come down when walking
- the knee orthosis does not pinch at any point
Size and manufacturer information can be found on the label sewn to the top edge of the knee orthosis.
Application of the knee orthosis:
- Push your thumb through the hole in the orthosis. The orthosis is placed on the wrist so The orthosis is placed on the knee so that both support splints fit on the outer and inner part of the knee.
- Tighten the orthosis using the hook-and-loop fasteners so that the pressure on the knee is not uncomfortable. When putting on the orthosis, it shou-ld not come into contact with sharp objects (e.g. jewellery) or long nails.
- The orthosis must be stretched evenly, without folds, so as to achieve the efficient pressure distribution.
- If you use body cosmetics, wait about 15 minutes after application before putting on the orthosis.
- Should the orthosis become visibly mechanically damaged, stop wearing it and repla-ce it with a new one.
Care and maintenance
Avicenum ORTHO 2000 Knee Orthosis Type 01 is a medical device intended for re- peated use by one person. The product will maintain its properties and safety for 12 months from the first use under these conditions:
- the knee orthosis can be machine washed after removing the splints (max. temperature 30 °C, gentle cycle) with a soapy solution or a special detergent for compression stockings and bandages, in a protective cover (washing bag)
- always leave the hook-and-loop fasteners fastened when washing
- do not use fabric softener
- do not use centrifugation, squeeze the wet knee orthosis between two towels
- lay flat to dry, away from a direct heat source (radiator, direct sunlight)
- do not iron the knee orthosis
- maximum number of washing cycles is 60
- store in a dark, dry place in the original packaging
- do not alter the knee orthosis in any way, do not repair areas damaged by use, do not trim the edges
- keep the knee orthosis away from organic solvents and bleaching agents
This medical device may be used safely for 36 months from the date of manufacture. This data is part of the product batch number expressed in the format YY/MM-1234567, where YY is the year and MM the month of manufacture.
Care symbols:
- Do not use fabric softeners
When not to use:
Stop using the medical device immediately if any of the following conditions apply:
- it shows sign of mechanical damage (replace the orthosis with a new one)
- you notice a deterioration in your health that may be associated with the use of the knee orthosis – consult your attending doctor in such case
Composition:
PAD Nylon, elastane, PES, metal
This medical device does not contain any active substance, including human
blood or plasma derivatives, tissues or cells of human origin or derivatives
thereof, or tissues or cells of animal origin or derivatives thereof
Disposal:
- The knee orthosis can be disposed of with normal household waste or recycled as a textile. Although the product is intended for use on healthy, intact skin, it may beco-me contaminated with body fluids during use. In this case, the knee orthosis should be disposed of as infectious material.
- The material used is non-toxic unless ignited. Never burn a used orthosis.
- Any serious adverse event occurring in connection with the product in question should be reported to the manufacturer and to the competent authority of the Member State where the user and/or patient is located:
Czech Republic| State Institute for Drug Control, Šrobárova 48, 100 41 Prague
10
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Slovakia| State Institute for Drug Control, Kvetná 1024/11, 821 08 Bratislava
Poland
| Office of Registration of Medical Products, Medical Products and Biological
Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Germany| Federal Institute for Drugs and Medical Devices, Kurt Georg Kiesinger
Allee 3, 53175 Bonn
Russia| Roszdravnadzor, Address: 4, bld. 1, Slavyanskaya Square, Moscow,
109074
Ukraine| Ministry of Health Ukraine, 7 Hrushevskoho Street, Kyiv, 01601
Australia| Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston
ACT 2609
Manufacturer:
ARIES, a.s., Studenec 309, 512 33 Studenec Last reviewed: 17.05.2021
ARIES, a.s., 512 33 Studenec 309 MADE IN CZECH REPUBLIC
ISO 9001:2015
www.avicenum.eu
References
Read User Manual Online (PDF format)
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