PROTAC Calm Ball Blanket Instruction Manual

: June 8, 2024
: PROTAC

PROTAC Calm Ball Blanket

PROTAC Calm Ball Blanket

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, Australia and New Zealand 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. The Protac Ball Blanket® is certified according to STANDARD 100 by OEKO-TEX® no. 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 sewn into the foot of the blanket.

Key to label symbols: please refer to Key to symbols

General precautions – Safety

Not for unsupervised use by users unable to care for themselves.
Not for unsupervised use by users with low lung capacity.
Not to be used as a means of restraint.
Please pay attention to the reaction of the user, if he or she does not like lying under the quilt.
When the Protac Ball Blanket® is used with an incontinence cover, it is important to be aware of the possible risks. The same risk precautions apply as for the use of a plastic bag:
- Incontinence covers are dangerous toys for children.
- A Protac Ball Blanket® used with an incontinence cover must not be used for children without supervision.
- A Protac Ball Blanket® used with an incontinence cover must not be used for patients unable to care for themselves without supervision.
- Protac Ball Blanket® used with an incontinence cover must not be pulled over the head.
Protac Ball Blanket® with polystyrene granulate contain small particles, and must not be used for children below the age of 3 without supervision.
Smoking is forbidden under the Protac Ball Blanket®. Embers from cigarettes can cause burns.
Never leave a computer or other electrical appliances switched on in a bed with a Protac Ball Blanket®, as they emit heat which can be harmful to the blanket, or in extreme circumstances, cause the appliance to ignite, due to a build-up of heat.
Must not be used near an open fire.

Incidents

Incidents related to the use of Protac Ball Blanket® must be reported to the manufacturer
Serious incidents related to the use of Protac Ball Blanket® 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 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 Ball Blanket® was developed to help sufferers of function impairment. Children, young and old people can benefit from the Protac Ball Blanket®

Brain damage, including spasticity, Huntington’s Chorea, Parkinson’s Disease and other ailments
ADHD and autism
Psychiatric diseases, such as dementia, schizophrenia, depression, anxiety, anorexia etc.
Development problems, sensory problems, deaf/blind, etc.
Stress

The Protac Ball Blanket® can be used for patients with brain damage resulting in spasticity. The weight and pressure of the balls help suppress spasticity, and calm the body of patients with brain damage. Furthermore, the patient benefits from enhanced body awareness.
The Protac Ball Blanket® is used by ADHD and autism sufferers to sleep with, and as a source of comfort during the daytime. The pressure and weight of the balls impart sensory stimuli which help define the body, giving comfort and calm. ADHD sufferers often have a problem winding down at night, and the Protac Ball Blanket® gives the body a signal to relax through its pressure and weight.
Psychiatric patients often suffer from muscular and psychological unrest. The Protac Ball Blanket® is used to create calm and comfort for the user. The weight and pressure of the balls also give a better feeling of body awareness and enhanced wellness. The Protac Ball Blanket® is used to sleep with, and to provide comfort during the daytime.
The Protac Ball Blanket® is used for sufferers of a range of development problems, sensory problems, deaf/blindness and to create enhanced sensory stimuli in the body.
The Protac Ball Blanket® is used for sufferers of stress to provide calmness, comfort and better body awareness. It is used to sleep with, and to provide comfort during the daytime. Sufferers of stress often have a problem feeling their body, preventing them falling asleep at night. The pressure and weight of the Protac Ball Blanket® give the body a signal to relax.
The Protac Ball Blanket® can be used in institutions, sheltered housing, day centres, hospitals, patient lounges and private homes. The blanket can be used in schools in classrooms or association areas, for instance. At home, the blanket can be used in a bedroom or the lounge.

Using the product

The user must enclose the Protac Ball Blanket® in a normal quilt cover.

Using the product

If the Protac Ball Blanket® is to be used by a child, we recommend allowing the child to play with it first while awake by crawling under it, or sitting with the blanket over his/her legs.

The Protac Ball Blanket® is ready for use.

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

Protac Ball Blanket® Classic

Item nos. 100-101, 100-102, can be machine washed in a min. 16 kg capacity washing machine. Use detergent without bleaching agents and perfume. Fabric softner may not be used. with washing detergent with no bleaching agents – see also the washing instructions on the Protac Ball Blanket®
Item nos. 100-107 baby can be washed in a min. 7 kg capacity washing machine. Use detergent without bleaching agents and perfume. Fabric softner may not be used. with washing detergent with no bleaching agents – see also the washing instructions in the Protac Ball Blanket®.

Protac Ball Blanket® Flexible

Item nos. 100-201, 100-215, 100-202, 100-226 can be machine washed in a min. 7 kg washing machine. Use detergent without bleaching agents and perfume. Fabric softner may not be used.. Remove the bags from the cover. The laundrybag delivered with 100-215 and 100-226 must be used when washing the bags. Wash cover and bags separately. Spinning at low speed – see also the washing instructions in the cover.

Protac Ball Blanket® Calm

Item nos. 100-321 and 100-322 should be split in three (Junior blanket in 2) each washed in a min. 7 kg capacity machine. Use detergent without bleaching agents and perfume. Fabric softner may not be used. The enclosed laundrybag must be used. Spinning at low speed – see also the washing instructions in the Protac Ball Blanket®.

To remove spots using a spot remover, always try first on an area which is not visible to test for damage or discolouring. Protac does not recommend the use of spot remover.
Protac cannot be held liable for incorrect washing and maintenance.

Maintenance

We recommend hanging the Protac Ball Blanket® out to air on a regular basis.

Transport and storage

The Protac Ball Blanket® is delivered in a carrying case so it is easy to handle.
During transport, the Protac Ball Blanket® is packed in a carton, which protects the blanket from dirt and moisture. If the blanket is not in use, store it securely in the carrying case so that it is protected from dirt and moisture.

Disposal

The Protac Ball Blanket® 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 of the chair 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:

overloading
misuse
non-maintenance or incorrect maintenance

Accessories

Protac Incontinence Cover

Using the product

General precautions – Safety

We recommend that the opening of the incontinence cover is at the opposite end to that of the duvet cover (not applicable for incontinence cover with mesh top)
The same risk precautions apply as for the use of a plastic bag:
- Incontinence covers are dangerous toys for children.
- A blanket used with an incontinence cover must not be used for children without supervision.
- A blanket with incontinence cover must not be used for patients unable to care for themselves without supervision.
- A blanket used with an incontinence cover must not be pulled over the head.
We recommend using the incontinence cover version with a mesh top (breathable material) for users unable to care for themselves.

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 in 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

Accessories

Protac Incontinence cover
Protac Bedlinen
Protac Cover with thermolining
Protac Carrying case

Parts List

Cover for Flexible blankets
Ball bags for Flexible blankets
Laundry bag

Technical specifications

Dimensions:

Patent: Protac Ball Blanket® Calm is registered as a Utility Model and Patented. Protac Ball Blanket® Flexible is registered as a Utility Model and Patented.
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.
Ignitability test: ISO 12952-1 & 2 : 2010- applies to Protac Ball Blanket® made of Trevira CS

Service information
No other balls can be used in a Protac Ball Blanket® than those used by the manufacturer.

Guide
– to daily inspection of the blanket before use