ottobock 50A10 Omo Immobil Individual Immobilisation of the Shoueldr Instruction Manual

50A10 Omo Immobil Individual Immobilisation of the Shoulder
Instruction Manual

Instructions for use …

| Size| body height
(cm / inch)
---|---|---
50A10=S| 50A11=L / R – S| ~150 – 165| ~58.5 – 64.5
50A10=M| 50A11=L / R – M| ~165 – 175| ~64.5 – 68.5
50A10=L| 50A11=L / R – L| ab ~175| From ~ 68.5

Foreword

INFORMATION
Date of last update: 2021-10-18
► 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 import­ ant when there is a decline in the health state.
► Please keep this document for your records.
These instructions for use provide you with important information on the fit­ ting and application of the 50A10 Omo Immobile and 50A11 Omo Immobil Rotation shoulder orthoses.

Product Description

50A10 scope of delivery (see Fig. 1)

Item| Description
1| Upper arm strap
2| Shoulder strap with shoulder pad
3| Waist strap
4| Orthosis
5| Abductor, 15°
6| Abductor, 30°, 60°, 90°
7| Auxiliary strap (optional)
8| Hook strip, double-sided
9| Straps for pressure redistribution in the shoulder/neck area, two pcs. (optional)
10| Tubular frame with textile cover, 10°, 20°, 30°
11| Hand support, padded, hook-and-loop
12| Forearm straps
50A11 scope of delivery (not illustrated)

Item| Description
1-12| 50A10 scope of delivery
13| 29A222 set for setting external rotation (elements for10°, 20° and 30° external rotation)

Intended use

3.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the shoulder and exclusively for contact with intact skin.
The orthosis must be used in accordance with the indications.
3.2 Indications
Indications must be determined by the physician.
50A10 Omo Immobile

• Posterior shoulder dislocation

• Shoulder instability

• Osteoporosis after sub capital humerus fracture

• Shoulder prosthesis implantation

• Rotator cuff repair/shoulder impingement syndrome
  50A11 Omo Immobil Rotation

• Anterior shoulder dislocation

• Bankart lesion

• Labral refixation in case of Bankart lesion

3.3 Contraindications
3.3.1 Absolute Contraindications
Not known.
3.3.2 Relative Contraindications
The following complaints require consultation with a physician: skin dis­ eases/injuries, inflammation, prominent scars that are swollen, reddening, and hyperthermia in the area treated; lymphatic flow disorders, including unclear soft tissue swelling distal to the device; sensory and circulatory dis­ orders in the area of the arm and the hand.
3.4 Lifetime
The product is designed for a maximum lifetime of 1 year.
3.5 Effects
50A10 Omo Immobile

• Immobilises and relieves the shoulder joint at 0°, 15°, 30°, 60° or 90° of abduction
• Can relieve pain

50A11 Omo Immobil Rotation

• Immobilises and relieves the shoulder joint at 0°, 15°, 30°, 60° or 90° abduction and 10°, 20° or 30° external rotation
• Can relieve pain

Safety

4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 General safety instructions
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.
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.

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).
INFORMATION
The orthosis should be applied and removed by two people in order to sup­ port the patient’s arm and gently hold it in place.
We recommend wearing a T-shirt or undershirt beneath the orthosis.
5.1 Size Selection
► Select the orthosis size based on the user height (see sizing table).
5.2 Adaptation
CAUTION
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.
CAUTION
Direct skin contact with the product
Skin irritation due to chafing or sweat formation
► Do not wear this product directly on the skin.
The 50A10 shoulder orthosis is delivered ready for fitting on the right side of the body.
50A10 – adapting for the left side of the body

1. Loosen the waist strap and hand support.
2. Move the waist strap to the same position on the opposite side of the orthosis. The strap guide loop is at the front (see fig. 2).
3. Loosen the arm closures and shoulder strap without pulling the shoulder pad off the shoulder strap.
4. Perform the adjustment for the left shoulder.
5. Turn the shoulder pad on the strap so the seam faces away from the body.

Adjusting the abduction angle
The desired abduction angle can be set with the hook-and-loop abductors.

1. Unfold the orthosis and position the abductor on the arm support from above where the torso and arm support meet (see fig. 3).
2. Fold over the arm support.
3. At 0° abduction, fasten the double-sided hook strip in the described pos­ edition.

Shortening the shoulder or waist strap (qualified personnel only)
Has the strap been shortened by qualified personnel?

The orthosis has been applied.
The hook-and-loop connections are on the front of the torso.

1. Mark the desired position on the strap.
2. Loosen the hook-and-loop closure from the strap.
3. Shorten the strap.
4. Fasten the hook-and-loop closure on the strap again.

50A11 – setting the external rotation
Required materials: 29A222 Elements for external rotation

1. Loosen the hook-and-loop connection of the upper arm and forearm pads so that the forearm pad can be pulled off the tubular frame (see fig. 4).
2. Remove the locking pins.
3. Pull off the forearm element and replace it with the chosen element for external rotation (see fig. 5). External rotation can be set to 10°, 20° or 30°, as desired.
4. Secure the tubular frame with the locking pins and cover it with the fore­ arm pad.
5. Refasten the hook-and-loop connection between the upper arm and fore arm pads.

5.3 Application
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 patient’s elbow is bent.

1. Open the shoulder strap, waist strap, and arm straps.

2. Pull the orthosis onto the arm and torso from below and guide the shoulder strap diagonally over the contralateral (sound) side (see fig. 6).

3. Position the shoulder pad fastened to the shoulder strap directly at the neck.

4. Pull the strap through the strap guide loop attached to the torso section and fasten it with the hook-and-loop. The strap guide loop is attached with a hook-and-loop patch that allows its position to be individually adjusted.

5. Pull the waist strap through the strap guide loop and fasten it (see fig. 7). The height of the waist strap that is attached with a hook-andloop patch can be individually adjusted.

6. Position the hook-and-loop hand support appropriately (see fig. 8).

7. Fasten the forearm straps and then the upper arm strap (see fig. 9).
   INFORMATION: The direction in which the arm straps are fastened can be individually selected (from inside to outside or from out­ side to inside). The optional auxiliary strap included in the scope of delivery can be used to further immobilize the upper arm (see fig. 10).

8. Optional: Use the enclosed straps for pressure redistribution in the area of the shoulder and neck. Use the hook strips attached to the shoulder pad for attachment. Shorten the straps if desired (see fig. 11).

5.4 Delivery
► Check that the orthosis is fitted properly before handing it over to the patient.
► Make sure that the orthosis does not cause pressure points in the armpit and the humeral head is not pushed up.
► Option: The qualified personnel can individually adapt the tubular frame in the area of the iliac crest.

5.5 Removal

1. Open the arm straps, waist strap and shoulder strap one after the other.
2. Move the orthosis sideways to remove it from the forearm and torso.

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.
Cleaning the textile cover and straps

1. Loosen the hook-and-loop hand support and the abductor from the orthosis.
2. Remove all hook-and-loop closures and the tubular frame.
3. Wash the textile cover and straps in warm water at 30 °C with a standard mild detergent. Rinse thoroughly.
4. Allow airing dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
5. The textile cover can be dried in a tumble dryer at a low-temperature set­ ting (gentle cycle).
6. After drying, pull the textile cover over the tubular frame. Refasten the hand support, hook-and-loop closures and abductor on the orthosis with hook-and-loop.

Optional: 29A217 spare cover available. We recommend using this when cleaning the textile cover.

Disposal

Dispose of the product in accordance with national regulations.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
8.1 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.
8.2 Liability
The manufacturer will only assume liability if the product is used in accord­ ance with the descriptions and instructions provided 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 unauthor­ used a modification of the product.
8.3 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic­ al devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

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

References

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