ottobock 50S5 Malleo Sensa Bock Active Stabilisation of the Ankle Instruction Manual
- June 3, 2024
- ottobock
Table of Contents
50S5 Malleo Sensa
Instructions for use
50S5 Malleo Sensa Bock Active Stabilisation of the Ankle
| Size| Side| Circumference above the ankle
---|---|---|---
cm| inch
| XS| links (L) / rechts (R)| 17 – 19| 6.7 – 7.5
S| links (L) / rechts (R)| 19 – 21| 7.5 – 8.3
M| links (L) / rechts (R)| 21 – 23| 8.3 – 9.1
L| links (L) / rechts (R)| 23 – 25| 9.1 – 9.8
XL| links (L) / rechts (R)| 25 – 27| 9.8 – 10.6
XXL| links (L) / rechts (R)| 27 – 29| 10.6 – 11.4
| Material | Knit Fabric: PA, EL |
|---|
Terry Cloth Covers: Baumwolle / Cotton, PES
Pad: viskoelastisches Technogel® / viscoelastic Technogel®
Foreword
INFORMATION
Date of last update: 2021-03-28
► Please read this document carefully before using the product and observe the
safety notices.
► Instruct the user on the safe use of the product.
► Please contact the manufacturer if you have questions about the prod uct 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 impor tant
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 50S5 Malleo Sensa ankle support.
Intended use
2.1 Indications for use
The support is intended exclusively for orthotic fittings of the ankle and
exclusively for contact with intact skin.
The support must be used according to the indication.
2.2 Indications
- Postoperative and posttraumatic irritation
- Joint effusion and periarticular swelling in case of arthrosis or arthritis
- Tendomyopathy
- Ligament weakness
- Feeling of instability
The indication must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
None known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin dis
eases/injuries, inflammation, prominent scars that are swollen, reddening, and
hyperthermia of the fitted limb/body area; lymphatic flow disorders, including
unclear soft tissue, swelling distant to the body area to which the medical
device will be applied; sensory and circulatory disorders in the foot area.
2.4 Mechanism of Action
The form-knitted support with an integrated shape-retaining pad provides ankle
compression. The support promotes sensorimotor functions and thereby activates
muscular stabilization.
Safety
3.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
3.2 General safety instructions
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.
CAUTION
Reuse of 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.
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.
Handling
INFORMATION
► The daily duration of use and period of application is generally deter
mined by the physician.
► The initial fitting and application of the product must be carried out by
qualified personnel.
► Instruct the patient in the handling and care of the product.
► Instruct the patient to see a physician immediately if any exceptional
changes are noted (e.g. worsening of the complaint).
4.1 Selecting the Size
- Measure the circumference above the ankle.
- Determine the size of the support (see size chart).
4.2 Application
CAUTION
Incorrect or excessively tight application
Skin irritation due to overheating, local pressure points due to tight appli
cation to the body
► Ensure that the product is applied properly and fits correctly.
► When in doubt, do not continue to use the product if skin irritation occurs.
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.
The L-shaped pad marks the outside of the ankle.
- Fold the support down enough so the heel can be grasped (see fig. 1).
- Pull the support over the foot up to the heel (see fig. 2).
- Unfold the section of the support that was folded over, i. e. unroll it upwards (see fig. 3).
- Pull up the support so that the openings in the pads are over the ankle bones (see fig. 4).
- When the patient is given support, it must be checked for proper fit and positioning.
4.3 Cleaning
NOTICE
Use of improper cleaning agents
Damage to the product due to the use of improper cleaning agents
► Only clean the product with the approved cleaning agents.
Clean the support regularly:
- Recommendation: Use a laundry bag or net.
- Wash the support in warm water at 30 °C (86°F) with standard mild detergent. Do not use fabric softener. Rinse thoroughly.
- Allow to air dry. Do not expose to direct heat (e.g. sunshine, stove, 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.
6.1 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 unautho
rized modification of the product.
6.2 CE Conformity
The product meets the requirements of Regulation (EU) 2017/745 on med medical
devices. The CE declaration of conformity can be downloaded from the
manufacturer’s website.
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Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0
F +49 5527 848-3360
healthcare@ottobock.de
www.ottobock.com
© Ottobock · 647G724=all_INT-13-2103
Documents / Resources
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ottobock 50S5 Malleo Sensa Bock Active Stabilisation of the
Ankle
[pdf] Instruction Manual
50S5 Malleo Sensa Bock Active Stabilisation of the Ankle, 50S5, Malleo Sensa
Bock Active Stabilisation of the Ankle, Bock Active Stabilisation, Active
Stabilisation, Stabilisation
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References
Read User Manual Online (PDF format)
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