ottobock 50A7 Epi Sensa Instruction Manual

: June 3, 2024
: ottobock

ottobock 50A7 Epi Sensa

Instructions for use

| Größe Size| Unterarmumfang
Forearm circumference
---|---|---
cm| inch
| XS| 17 – 19| 6.7 – 7.5
S| 19 – 21| 7.5 – 8.3
M| 21 – 23| 8.3 – 9.0
L| 23 – 25,5| 9.0 – 10.0
XL| 25,5 – 28| 10.0 – 11.0
XXL| 28 – 31| 11.0 – 12.2

ottobock-50A7-Epi-Sensa-03

Material	Gestrick / Knit Fabric: PA, EL

Frotteebezüge / Terry Cloth Covers: Baumwolle / Cotton, PES, EL
Pelotte / Pad: viskoelastisches Technogel® / viscoelastic Technogel®

Foreword

INFORMATION

Date of last update: 2021-02-12

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 in connection with the product, in particular a worsening of the state of health, to the manufacturer and to the relevant authority in your country.
Please keep this document for your records.

These instructions for use provide important information on the fitting and application of the 7126 shoulder support.

Intended use

Indications for use

The support is intended exclusively for orthotic fittings of the shoulder and exclusively for contact with intact skin.
The support must be used according to the indication.

Indications

Irritation in the shoulder region
Degeneration of the rotator cuff
Tend myopathy in the shoulder region
Osteoarthritis of the shoulder
The indication must be determined by the physician.

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 in the relevant area; pronounced varicose veins, especially with impaired blood return, lymph drainage disorders and unclear soft tissue swelling distal to the device; sensory and circulatory disorders in the area of the forearm and hand, e.g. associated with diabetic neuropathy.

Mechanism of Action

The form-knitted support with integrated shape-retaining pad provides elbow compression. The support promotes sensorimotor functions and thereby activates muscular stabilization.

Safety

Explanation of warning symbols

CAUTION
Warning regarding possible risks of accident or injury.
NOTICE
Warning regarding possible technical damage.

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 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.

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.

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.
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).

Selecting the Size

Measure the circumference of the upper arm.
Determine the size of the support (see size chart).

Application

CAUTION
Incorrect or excessively tight application
Skin irritation due to overheating, local pressure points due to tight application 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.

Fold over the top section of the support so that the pad pockets are exposed (see fig. 1).
Pull the support over the forearm up to the elbow.
Fold back the section of the support that was folded over and pull the support over the elbow (see fig. 2).
Position the support so that the epicondyles lateralis and epicondyles medial is are positioned in the pad openings (see fig. 3).
When the patient is given the support, it must be checked for proper fit and positioning.

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.

Clean the support regularly:

Recommendation: Use a laundry bag or net.
Wash the support in warm water at 40 °C (104 °F) with standard mild detergent. Do not use fabric softener. Rinse thoroughly.
Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, 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.

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.