ottobock 50P13 Manu Sensa Active Wrist and Hand Support Instruction Manual

: June 4, 2024
: ottobock

ottobock 50P13 Manu Sensa Active Wrist and Hand Support

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Foreword

INFORMATION
Date of last update: 2021-08-20

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 50P13 Manu Sensa wrist 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

The indication must be determined by the physician.

Irritation (e.g. tendovaginitis, tendomyopathy, minor joint effusion, post-traumatic [sprains], post-operative, reactive irritation, and arthralgia)
Rheumatoid arthritis
Carpal tunnel syndrome
Osteoarthritis of the wrist
Feeling of instability

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 provides targeted wrist compression and stabilization. The support promotes sensorimotor functions and activates muscular stabilization. The anatomically pre-shaped and individually adaptable volar plastic splint keeps the hand in an ideal position and limits wrist movement. The pad in the radial section of the wrist enhances the micro- massage and promotes the resorption of edemas, hematomas and effusions.

Lifetime

The product is designed for a maximum lifetime of 6 months.

Safety

Explanation of warning symbols

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

General safety instructions

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.

CAUTION
Contact with heat, embers or fire
Risk of injury (suchÂ 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.

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 wrist circumference.
Determine the size of the support (see size chart).

Adaptation

Improper molding or application
Damage to the product due to overloading of the material and improper fit of the product due to breakage of load-bearing components

The product may only be molded by qualified personnel.
Do not make any improper changes to the product.
Always apply the product according to the information in the instructions.

The plastic splint is anatomically pre-shaped. The splint can be heated and then individually shaped.

Heat the splint using a hot air gun.
Shape the splint.
Allow the splint to harden.
Insert the splint into the pocket on the inside of the support (see fig. 1).

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.
- Optional: The supplied strap can be used for additional stabilization. Pull the elastic strap around the wrist and fasten the hook-and-loop closure (see fig. 4).
- Check the proper fit of the support.

Cleaning

NOTICE
Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents

Remove all plastic splints.
Fasten all hook-and-loop closures.
Recommendation: Use a laundry bag or net.
Wash the support in warm water at 86 °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).
Reinsert the plastic splints in the support.

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.