PROTAC Sensory Stimulating Aids User Guide

: July 17, 2024
: PROTAC

Table of Contents

PROTAC Sensory Stimulating Aids
Product Information
Product Usage Instructions
FAQ
Directions for use
Using the product
Cleaning
Maintenance
Transport and storage
Key to symbols
Technical specifications
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

PROTAC Sensory Stimulating Aids

PROTAC-Sensory-Stimulating-Aids-PRODUCT

Product Information

Specifications

Manufacturer: Protac A/S
Address: Niels Bohrs Vej 31 D, Stilling DK-8660 Skanderborg
Contact: Tel.: 86 19 41 03, Email: protac@protac.dk
Product Type: Medical Device
Areas of Use: Designed for sensory stimulation in healthcare sectors

Product Usage Instructions

Safety Guidelines

Follow the safety guidelines provided in the manual for safe usage of the product.

Product Application

The product can be used by placing it in a pocket for known objects like keys.

Maintenance and Cleaning

Use a mild detergent without bleaching agents and perfume for cleaning. Follow the washing instructions on the cover.

Product Lifespan

The product is expected to have a service life of 5 years based on correct use, cleaning, washing, and maintenance.

FAQ

Q: Can I use spot removers on the product?

A: Protac does not recommend the use of spot removers as they may cause damage or discoloration. Always test on an inconspicuous area first.

Q: What should I do if the product exceeds its service life?

A: Products used beyond the stated service life should be evaluated for further use. The responsibility lies with the user for using the product beyond its recommended lifespan.

Directions for use

Protac KneedMe®

You have chosen a Protac quality product. Protac guarantees that you have purchased an original Danish-designed product developed in partnership with professionals.
Since 1994, Protac has developed, manufactured, and sold sensory stimulating aids to the healthcare sectors in Denmark, Europe, Australia, and New Zealand.
Protac products are developed from the theory of sensory integration and are well documented in research, documentation, and case descriptions.
Protac production process focuses on environment and safety. Protac plastic balls are certified STANDARD 100 by OEKO-TEX® nr. 2076-310 DTI.
For more details, go to www.protac.dk

Labeling

The products are labeled under Regulation (EU) 2017/745 Class I medical devices. CE- and care labels with information about the manufaturer, raw materials, washing instructions, and LOT number are placed inside the cover.
Key to label symbols: please refer to Key to symbols

General precautions – Safety

Please note that the Protac KneedMe® is not intended as a restriction of personal freedom or as a safety device.
If a user’s movements or impaired cognitive abilities accidentally cause the blanket to slip to the floor, we recommend keeping the user under supervision.
Take precautions to avoid pressure sores when using Protac KneedMe®.
Cease using the product if there are any signs of redness or irritation on the user’s thighs or buttocks as a result of using Protac KneedMe®.
Not suitable for use on children.
When using Protac KneedMe® in a car, it must not be used by the person driving the car.
If a passenger is using Protac KneedMe®, it must lie loosely over the knees
Must not be used near an open flame.

Incidents

Incidents related to the use of Protac KneedMe® must be reported to the manufacturer
Serious incidents related to the use of Protac KneedMe® be reported to the manufacturer and the competent authority of the country where the incident takes place.

Product purpose and areas of use

Sensory integration is the idea behind the development of all Protac products. The theory originated in the 1970s in the USA and was developed by A. Jean Ayres, an occupational therapist and psychologist.
The theory is based on how the brain processes sensory impressions, and how the various sensory stimuli can be influenced by applying weight and pressure to the tactile sense (the sense of touch) in the skin and the proprioceptive sense (the sense of movement) in muscles and joints.
The pressure, movement, and weight of the balls act on these senses in particular.
Protac KneedMe® has been developed as an aid for people with disabilities.

Adults and the elderly can use Protac KneedMe®:

Brain damage and other neurological diseases.
ADHD and Autism
Psychiatric diseases
Developmental disorders, sensory disorders.
Physical and mental unrest.
Concentration problems and learning difficulties.
Protac KneedMe® is used by people with brain injuries and other neurological diseases. These patients often suffer from neurogenic disorders.
The movements and pressure of the balls give the body sensory stimuli that contribute to an increased body sensation.
For people with ADHD and autism, Protac KneedMe® is used to create calm and concentration. The movements and pressure of the balls on the body provide sensory stimuli that create calmness and help to define the body.
The use of the knee blanket enables users to maintain concentration for longer periods.
Protac KneedMe® is used for people with psychiatric illnesses. Many have violent movements and psychotic behavior which subsides when they get the knee blanket over them. Patients become more present in contact with others.
Protac KneedMe® is used for people with eg developmental disorders, and sensory disorders to create increased sensory stimulation for the body.
Protac KneedMe® is used for people with physical and mental unrest, such as restlessness in the legs. The movement of the balls in the knee blanket provides sensory stimuli in the legs and an increased body sensation and calmness
Protac KneedMe® is used for people with concentration problems and learning difficulties. The balls in the knee blanket provide sensory stimuli which contribute to an increased body sensation.

Using the product

The Protac KneedMe® is laid over the user’s lap.
Non-slip grip sheet on the reverse side.
A carabiner hook is sewn into the top of the pocket for objects such as keys which the user likes to touch.

Product service life

The product has an expected service life of 5 years.
This is based on correct use, cleaning, washing, service, and maintenance.
Products used beyond the aforementioned service life should be assessed for further use. Responsibility for using the product beyond the stated service life rests with the user.

Cleaning

Protac KneedMe® is washable. The regularity and need for washing depends on use. When washing Protac KneedMe®, follow the instructions below.
Protac KneedMe® can be machine washed in a minute. 7 kg capacity washing machine. Use a detergent with no bleaching agents and perfume – see the washing instructions on the cover.
The cover and ball bag must be washed separately. The laundry bag supplied is recommended for washing the ball bag.
To remove spots using a spot remover, always try first on an area that is not visible to test for damage or discoloring. Protac does not recommend the use of spot remover.
Protac cannot be held liable for incorrect washing and maintenance.

Maintenance

We recommend airing the knee blanket regularly.
Check the Protac KneedMe® every time it is used for defects and deficiencies, and inspect the seams, zip, fabric, balls, and general condition once a year.
If any serious defects are found, withdraw the blanket from use until repairs have been made and it is safe to use again.

Transport and storage

The Protac KneedMe® is supplied in a handy carrying case.
If the blanket is not in use, store it carefully in its bag.

Disposal

The Protac KneedMe® can be broken down into the following components for disposal.
Plastic and textile.
The plastic balls can be disposed of as hard plastic
All parts can be disposed of as combustible waste.
Waste must be disposed of in accordance with applicable rules.

Guarantee

2-year guarantee against manufacturing defects.
The guarantee will be invalid in the event of the following.
over-use
misuse
non-maintenance or incorrect maintenance
Traceability: Production month, year, and LOT number are marked on the washing label. These must not be removed from the product.

Key to symbols

Example only. Always follow the recommended care instructions on the label found inside the product.
Washing bowl: Maximum washing temperature (see care label)
Triangle: Do not bleach
Square with a circle: tumble drying possible (see care label)
Iron: Do not iron
Circle: Do not dry clean
Warning: See under Safety
User information
For indoor use
CE marked according to (EU) 2017/745 Class I medical devices
Manufacturer
LOT number

Technical specifications

Standards: Comply with general requirements for aids acc. to the following harmonized standards.
EN ISO 13485:2016/A11:2021: Medical Devices – Quality Management systems
EN ISO 14971:2019/A11:2021: Medical devices – Application of risk management to medical devices DS/EN ISO 21856:2022: Medical devices – Assistive products – General requirements and test methods.

Service Information