PROTAC KneedMe Sensory Stimulating Knee Blanket Instruction Manual

: June 8, 2024
: PROTAC

PROTAC KneedMe Sensory Stimulating Knee Blanket

PROTAC KneedMe Sensory Stimulating Knee Blanket

Directions for use

Protac KneedMe®

You have selected a quality Protac product. Protac guarantees that you have purchased an
original, Danish designed product developed in consultation with experts. Protac has developed, produced and sold sensory-stimulating aids to the healthcare sector in
Denmark, the rest of Europe and Australia since 1994. Protac products are developed on the basis of theories on sensory integration, and are supported by extensive research, documentation and case studies. Protac focuses strongly on protection of the environment and safety during its production process. Protac plastic balls are certified STANDARD 100 by OEKO-TEX® nr. 2076-310 DTI.

For more details, go to 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 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 heavy products.
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 the blanket.
Not suitable for use on children.
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 impresions, and how the various sensory stimuli can be influenced via 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.

The Protac Kneed Me® is developed as an aid for people with disabilities. It can be used by adults and the elderly. Protac Kneed Me® is used for patients suffering from physical and psychiatric restlessness. Sudden, violent movements and aggressive behavior are common, which rescind when wearing the blanket. Patients become more approachable when in contact with others. The Protac Kneed Me® can be used in institutions, sheltered housing, day centers, hospitals, patient lounges and private homes. At home, the blanket can be used in a bedroom or the lounge.

Using the product

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® blankets can be washed. The regularity and need for washing depends on use. See below for washing and cleaning instructions.

Protac Kneed Me® can be machine washed in a min. 7 kg capacity washing machine. Use a detergent with no bleaching agents – see also 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.
The laundry bag supplied is recommended for washing.

To remove spots using a spot remover, always try first on an area which 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 blanket regularly.
Check the Protac Kneed Me® 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 to protect from dirt and damp.

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 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
| Manufacturer
Batch 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.