Protac KneedMe Sensory Stimulating Knee Blanket Instruction Manual

Protac KneedMe ® To Go
Directions for use Medical Device

Protac KneedMe Sensory Stimulating Knee Blanket

You have chosen a Protac quality product. Protac guarantees that you have acquired an original, Danish design product, developed in cooperation with professional business partners.Since 1994, Protac has been designing, producing and selling sensory-stimulating devices for the health sector in Denmark, Europe and Australia.
Protac’s products are developed on the basis of theories about sensory integration and are well-evidenced in terms of research, documentation and case studies. In the manufacturing process. Protac plastic balls are certified STANDARD 100 by OEKO-TEX ® nr. 2076-310 DTI.
For further information see www.protac.dk
Labelling
The products are labeled in accordance with Regulation (EU) 2017/745 Class I medical devices. CE- and carelabels with information about the manufaturer, raw materials and washing instructions are placed inside the cover.
Key to label symbols: please refer to Key to symbols

General precautions – Safety

Please note that Protac KneedMe® To Go is not intended to curtail personal freedom or to be asafety device.

• The shoulder strap of the knee blanket can be used as a belt. This must only be fastened
  around the waist of the user, and never around the back of a chair. The belt prevents the kneeblanket from slipping down when being used. When the strap has been adjusted and tightened correctly, it should fit closely around the user, comfortably and without being too tight.

• Users who are unable to unfasten the belt and free themselves from the knee blanket withoutassistance, should always be supervised.

• If a user’s movements or reduced cognitive abilities inadvertently lead to release from the knee blanket, we recommend that the user should also be supervised.

• Do not use near an open flame.

• Avoid tripping over the shoulder strap/belt.

• 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. Do not use theshoulder strap around your waist as a belt.

The product’s purpose and application environment
Sensory integration is the basis for the design of all Protac’s products. This theory originated in the United States and was developed by A. Jean Ayres, an occupational therapist and psychologist, back in the 1970s. The theory is based on how the brain processes sensory impressions, and how one can influence the various sensory stimuli via weight and tactile sense (the sense of touch) in the skin and the proprioceptive sense (sense of movement) in the muscles and joints. The pressure, movement and weight of the balls have an impact on these senses.
Protac KneedMe® To Go is developed as an aid for people with disabilities.
Children from the age of 5/6 can use Protac KneedMe® To Go:

• Motoric and mental unrest
• Difficulty concentrating
• Sensory disturbance
• ADHD
• Autism
• Developmental irregularities

Protac KneedMe® To Go is ideal for users with motoric and mental unrest. Many children and young people have problems sensing themselves, but when they have one of these knee blankets on, they get an excellent awareness of their body. They calm down and concentrate. Protac KneedMe® To Go can be used in institutions, residences, day care facilities, hospitals, common rooms and private rooms. In the home, Protac KneedMe® To Go can be used, for example, in the user’s bedroom and in the living room.

Use of the product

The product’s service life
The product has an expected service life of 5 years.
The service life is based on proper use, cleaning, washing, service and maintenance. Products, which are used for longer than the above-mentioned service life, should be assessed prior to further use. It is the responsibility of the user to check regularly whether the product can be used for longer than the stipulated service life.

Cleaning

Protac KneedMe® To Go is washable. How frequently it needs washing depends on use. When washing and cleaning, please follow the instructions below.
Protac KneedMe® To Go

• Protac KneedMe® To Go can be washed in a washing machine with a min. capacity of 7kg, using washing detergent without bleach. Spinning at low speed. Also see the washing instructions in the cover.
• The cover and ball bag should be washed separately. For the ball bag, we advise you to use the washing bag that comes with the product.

For removing stains, when you are considering using a stain remover, first try it on a place that is not visible, to see whether it might damage the fabric or affect the colour. Protac does not recommend the use of stain removers.
Protac reserves the right not to replace a product that has been wrongly washed and maintained.

Maintenance

We recommend airing the knee blanket regularly. Check your Protac KneedMe® To Go every time you use it for flaws and defects, and once a year inspect the knee blanket’s seams, zip, fabric, plastic balls and general condition.If you become aware of a serious flaw or defect, stop usingyour Protac KneedMe®
To Go until the flaw has been remedied and safety restored.

Transport and storage
Protac KneedMe® To Go comes ready to use.
During transport, the knee blanket is packed in plastic to protect it against dirt and moisture.
When the knee blanket is not being used, it should be stored safely to protect it against dirt and moisture.
Disposal
When disposing of a Protac KneedMe® To Go, it can be divided into the following parts: plastic and fabric.
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.
Warranty
There is a 2-year warranty for manufacturing defects
The warranty is void in the following instances:

• Overload of the Protac KneedMe® To Go
• Heavy-handed use of the Protac KneedMe® To Go
• Lack of, or improper maintenance of the Protac KneedMe® To Go

Traceability: Production month, year and batch 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  Class I
| Manufacturer
| Batch number

Technical specifications

Standards: Comply with general requirements for aids acc. to the following harmonized standards:
Clinical evaluation: EN 12182:2012
Risk analysis: DS/EN ISO 14971
Service information
Do not use balls in your Protac KneedMe® To Go other than those used by the manufacturer.
Guide
– to daily inspection Protac KneedMe® To Go prior to use

Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Tel.: 86 19 41 03
e-mail: protac@protac.dk
Distributor list: Please refer to: www.protac.dk/kontakt
5.7-1 – Protac KneedMe® To Go – Oktober 2021 – Vers. 2
www.protac.dk

References

• Protac.dk | Beroligende og sansestimulerende hjælpemidler med kugler

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