ottobock 8320N Knee Brace Patella Pro Instructions
- June 5, 2024
- ottobock
Table of Contents
ottobock 8320N Knee Brace Patella Pro
Foreword
INFORMATION
Date of last update: 2022-02-18
- Please read this document carefully before using the product and observe the safety notices.
- Instruct the user in the safe use of the product.
- Please contact the manufacturer if you have questions about the product or in case of problems.
- Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
- Please keep this document for your records.
These instructions for use provide important information on the fitting and application of the 8320N Patella Pro patella re-alignment brace.
Product description
8320N Patella Pro (see fig. 1 )
Item| Designation| Item| Designation
1| Donning loops| 5| Re-alignment element
2| Ratchet straps| 6| Doffing loops
3| Hook-and-loop guides| 7| Ratchet strap buckle
4| Patella cutout| 8| Patella support
Intended use
Indications for use
The brace is intended exclusively for orthotic fittings of the lower limbs and
exclusively for contact with intact skin. The brace must be used in
accordance with the indications.
Indications
The indication must be determined by the physician.
- Patellofemoral misalignment
- Patellofemoral pain syndrome
- Retropatellar osteoarthritis
- Chondropathy/chondromalacia patellae
- Condition after patella luxations and subluxations
- Condition after injury to the patellar tendon
- Anterior knee pain after surgical procedures on the knee joint (e.g. total knee replacement, lateral release surgery)
Contraindications
Absolute Contraindications
None known.
Relative Contraindications
The following indications require consultation with a physician: skin
diseases/injuries; inflammation; prominent, swollen scars; reddening and
hyperthermia of the treated limb; pronounced varicose veins, especially with
impaired return flow; lymphatic flow disorders, including unclear soft tissue
swelling distal to the body area where the device will be applied; sensory and
circulatory disorders in the legs, e. g. associated with diabetic neuropathy.
Lifetime
The product is designed for a maximum lifetime of 1 year.
Restrictions for use
Inform the patient that the brace should not be used without the sports cover
for sports where there may be bodily contact with other persons. The brace is
suitable for sports that may involve bodily contact with other persons
(contact sports) exclusively in combination with the 29K129 sports cover.
Mechanism of Action
The dynamic re-alignment mechanism provided by the brace guides the patella
within the physiologically correct patellofemoral groove. It does this
without increasing the pressure caused by the tracking system in relation to
the flexion angle.
Safety
Explanation of warning symbols
CAUTION
Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.
General safety instructions
Reuse on other persons and improper cleaning Skin irritation, formation of
eczema or infections due to contamination with germs
- The product may be used by one person only.
- Clean the product regularly.
CAUTION
Contact with heat, embers or fire Risk of injury (such as burns) and risk
of product damage Keep the product away from open flames, embers and other
sources of heat.
NOTICE
Contact with oils, salves, lotions or other products that contain oils or
acids Insufficient stabilization due to loss of material functionality Do not
expose the product to oils, salves, lotions or other products that contain
oils or acids.
NOTICE
Improper use and changes Change in or loss of functionality as well as damage
to the product
- Use this product with care and only for its intended purpose.
- Do not make any improper changes to the product.
NOTICE
Use of a worn or damaged product Limited effectiveness
- Before each use, check the product for functional reliability and for possible wear or damage.
- Do not continue using a product that is no longer functional, or that is worn or damaged.
Handling
INFORMATION
- The daily duration of use and period of application are generally determined by the physician.
- The initial fitting and application of the product must be carried out by qualified personnel according to the instructions of the treating physician.
- Consult a physician if any exceptional changes are noted (such as worsening of the complaint).
Selecting the Size
- Measure the circumference of the thigh 15 cm above the center of the patella.
- Measure the circumference of the lower leg 15 cm below the center of the patella.
- Determine the size of the brace (see size chart).
Adaptation
Incorrect or excessively tight application Risk of local pressure and
constriction of blood vessels and nerves due to improper or excessively tight
application Ensure that the product is applied properly and fits correctly.
INFORMATION
Adaptation of the brace by the patient The patient may only use the ratchet
strap buckle. Other adaptations
- Make sure that the ratchet strap buckle of the patella support and the closures of the ratchet straps are open.
- Ask the patient to grasp the brace on the donning loops and pull it over the leg until the patella is positioned in the center of the patella cutout.
- Check the position of the patella in the patella cutout and correct the fit of the brace if necessary.
- Close the ratchet strap buckle of the patella support in the neutral position (N)
- Position the patient’s leg at 20° to 30° of flexion.
- Guide the patella support to the edge of the patella by tightening the two ratchet straps The position is correct when the patella support is up against the edge of the patella. Observe the following table if further corrections are required.
- Align the hook-and-loop guides at the front of the patella support to correct the position of the patella support on the patella.
- Cut off the two spring pull-out limiters
- Carefully flex and extend the patient’s leg, only moving it within the range approved by the attending doctor (see fig. 8). Check the fit of the patella support and springs, and make corrections as needed (see the following table).
- Mark the final length of the ratchet straps
- Ask the patient to open the ratchet strap buckle and pull the brace down off the leg by the doffing loops
- Shorten the ratchet straps along the markings and debur the cut edges.
- Insert the ratchet straps fully into the closures and fasten the closures
- Remove the remains of the spring pull-out limiters from the inside of the brace.
Optional correction of the fit
Re-alignment ele ment(see fig. 1 , item 5):| 1. To adjust the position of the patella support, move the two hook- and-loop closures lying above each other horizontally together.
2. Move the upper hook-and-loop closure to adjust the freedom of movement. Always position the hook-and-loop closures on top of each other horizontally.
Additional fixation:| Use the 29K283 strap set for additional fixation of the brace.
Application
Prerequisite: The ratchet strap buckle on the patella support has been opened
(see fig. 2).
- Grasp the brace on the donning loops and pull it over the leg until the patella is positioned in the center of the patella cutout.
- Close the ratchet strap buckle of the patella support in the middle position. In case of volume fluctuations in the course of the day, the ratchet strap buckle can be closed in the tighter or looser position.
Removal
- Open the ratchet strap buckle of the patella support.
- NOTICE! Do not pull on the patella cutout. Grasp the brace on the doffing loops and pull it down off the leg.
Cleaning
NOTICE
Use of improper cleaning agents Damage to the product due to use of improper
cleaning agents
- Only clean the product with the approved cleaning agents.
- NOTICE! Use a laundry bag or net when washing.
- INFORMATION : Do not open or move any hook-and-loop closures. That changes the adjustment of the brace. Close the ratchet strap buckle.
- Wash the brace in warm water at 30 °C with standard mild detergent. Do not use fabric softener. Rinse thoroughly.
- Allow to air dry. Avoid exposure to direct heat (e.g. from the sun, an oven or radiator).
Disposal
Dispose of the product in accordance with national regulations.
Legal Information
All legal conditions are subject to the respective national law of the country of use and may vary accordingly.
Local Legal Information
Legal information that applies exclusively to specific countries is written in
the official language of the respective country of use after this chapter.
Liability
The manufacturer shall be liable in the event that the product is used in
accordance with the descriptions and instructions in this document. The
manufacturer will not assume liability for damage caused by disregarding the
information in this document, particularly due to improper use or unauthorized
modification of the product.
CE Conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical
devices. The CE declaration of conformity can be downloaded from the
manufacturer’s website.