Ottobock 5055 Acro ComforT Instruction Manual

: June 3, 2024
: ottobock

Ottobock 5055 Acro ComforT

Ottobock-5055-Acro-ComforT-product-image

Foreword

INFORMATION

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 applying the 5055 Acro ComforT shoulder support.

Intended use

Indications for use

The support is intended exclusively for treating the upper limbs 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
Shoulder instability
Indications must be determined by the physician.

Contraindications

Absolute Contraindications
Not 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.

Effects

The support stabilizes the shoulder joint, supports shoulder guidance and relieves pain.

Safety

Explanation of warning symbols

CAUTION
Warning regarding possible risks of accident or injury.

NOTICE
Warning regarding possible technical damage.

General safety instructions

CAUTION
Use of a product with neoprene
Allergic reactions due to neoprene or heat allergies

Do not wear products with neoprene for more than 3 – 4 hours without interruption (unless explicitly instructed otherwise by the doctor).
Do not use the product in case of a known neoprene or heat allergy.

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
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
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 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).

Size Selection

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.
Open all hook-and-loop closures on the support.

Pull the support over the arm (see fig. 1).
Feed the long strap under the opposite arm and fasten it in front of the chest (see fig. 2).
Adjust and fasten the hook-and-loop closures at the shoulder (see fig. 3).

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:
1. Fasten all hook-and-loop closures.
2. Recommendation: Use a laundry bag or net.
3. Wash the support in warm water at 40 °C with standard mild detergent. Do not use fabric softener. Rinse thoroughly.
4. 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 laws of the country of use and may vary accordingly.

Liability

The manufacturer will only assume liability if the product is used in accordance 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 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.