PROTAC Granulate Ball Blanket Instructions

PROTAC Granulate Ball Blanket

Directions for use

Protac Granulate Blanket®
Protac Granulate Blanket® Flexible

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. Protac Granulate 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 to avoid irritating the user.
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.

• Pay attention to the reaction of the user, if he or she does not like lying under the quilt.

• When the Protac Granulate 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 Granulate Blanket®,used with an incontinence cover must not be used for children with out supervision.
  • A Protac Granulate Blanket®, used with an incontinence cover must not be used for patients unable to care for themselves without supervision.
  • A Protac Granulate Blanket®, used with an incontinence cover must not be pulled over the head.

• Protac Granulate Blanket®, with polypropylene granulate contain small particles,
  and must not be used for children below the age of 3 without supervision.

• Smoking is forbidden under the Protac Granulate Blanket®. Embers from cigarettes can cause burns.

• Never leave a computer or other electrical appliances switched on in a bed with a Protac Granulate Blanket®, as they emit heat which can be harmful to the Protac Granulate 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 Granulate Blanket® must be reported to the manufacturer
• Serious incidents related to the use of Protac Granulate 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 impressi-ons, 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 Granulate Blanket® were developed to help sufferers of function impairment. Children, young and old people can benefit from the Protac Granulate 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 Granulate Blanket® can be used for patients with brain damage resulting in spasticity. The weight of the blanket helps suppress spasticity, and calm the body of patients with brain damage. Furthermore, the patient benefits from enhanced body awareness.

The Protac Granulate Blankets are used by ADHD and autism sufferers to sleep with, and as a source of comfort during the daytime. The pressure of the blanket imparts sensory stimuli which helps define the body, giving comfort and calm. ADHD sufferers often have a problem winding down at night, and the Protac Granulate Blanket® gives the body a signal to relax through its weight.
Psychiatric patients often suffer from muscular and psychological unrest. The Protac Granulate Blankets are used to create calm and comfort for the user. The weight of the blanket also gives a better feeling of body awareness and enhanced wellness. Protac Granulate Blankets are used to sleep with, and to provide comfort during the daytime.

The Protac Granulate Blankets are used for sufferers of a range of development problems, sensory problems, deaf/blindness and to create enhanced sensory stimuli in the body.
The Protac Granulate Blankets are 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 Granulate Blanket® gives the body a signal to relax.

Protac Granulate Blanket® can be used in institutions, sheltered housing, day centres, hospitals, patient lounges and private homes. The Protac Granulate Blanket® can be used in schools in classrooms or association areas, for instance. At home, the Protac Granulate Blanket® can be used in a bedroom or the lounge.

Using the product
The user must enclose the Protac Granulate Blanket® in a normal quilt cover.

If the Protac Granulate 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 Granulate Blanket® is delivered 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

All Protac Granulate Blanket® can be washed. The regularity and need for washing depends on the use. See below for washing and cleaning instructions.

Protac Granulate Blanket®

Item nos. 100-419, 100-429 must be split in two parts. Each part to be washed separately in a washing machine with min 7 kg capacity. Use detergent without bleaching agents and perfume. Fabric softner may not be used. Use the enclosed laundrybag. Spinning at low speed – see also the washing instructions on the cover.

Protac Granulate Blanket® Flexible

• Item nos. 100-219, 100-220 can be machine washed in a in a washing machine with min. 7 kg capacity. Use detergent without bleaching agents. Fabric softner may not be used. Remove the bags from the cover. Wash the cover and bags separately. Use the enclosed laundrybag. Spinning at low speed – see also the washing instructions on the cover.

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 Granulate Blanket® out to air on a regular basis.

Transport and storage

• The Protac Granulate Blanket® is delivered in a carrying case so it is easy to handle.
• During transport, the Protac Granulate 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 Granulate Blanket® can be broken down into the following components for disposal: Plastic and textile.
All components can be disposed of as combustible refuse.
Always dispose of refuse according to local rules.

Warranty

There is a two-year warranty against manufacturer’s defects.

The warranty will be voided in the following cases

• 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 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

Accessories

• Protac Incontinence cover
• Protac Bedding
• Protac Cover with thermolining
• Protac Carrying case

Spare parts

• Cover for Flexible
• Ballbags for Flexible
• Laundry bag

Technical specifications

Dimensions:
Protac Granulate Blanket®

• length: 200/220 cm
• width: 140 cm

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 : 2010 – applies only to blankets made of Trevira CS

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

Guide to daily inspection of the blanket before use No. Check

• All parts are in place, no loose parts
• No sign of holes, damage to the textile or seams

Protac A/S
Niels Bohrs Vej 31 D, Stilling DK-8660 Skanderborg Denmark
Tel.: +45 86 19 41 03
e-mail: protac@protac.dk

Distributor list: Please refer to: www.protac.dk/kontakt

References

• Protac.dk | Beroligende og sansestimulerende hjælpemidler med kugler

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>