Protac Senscircle 100% Polyester Multi Pillow User Manual

PROTAC SensCircle 100% Polyester Multi Pillow

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, producingand selling sensory-stimulating devices for the health sector in Denmark, Europe, Australia and New Zealand. 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 focuses on environmental and safety issues. Protac plastic balls are certified STANDARD 100 by OEKO-TEX® nr. 2076-310 DTI.
For more information, go to www.protac.dk
Labelling
The products are labeled in accordance with Regulation (EU) 2017/745 Class I medical devices. CE- and care labels with information about the manufacturer, raw materials and washing instructions are attached inside the cover to protect the user from discomfort when being used. Key to label symbols: please refer to Key to symbols

General precautions – Safety

• Pay attention to the user’s reaction if s/he does not like being encased by the pillow. This might be expressed by bursts of anger or anxiety.
•  Make sure that the user does not feel too hot, when encased by the pillow.
• Make sure you use Protac SensCircle® appropriately to avoid the danger of tripping up.
• Be aware of whether any balls are causing the user discomfort. This is particularly important if the user is unable to move.
•  It must never be used, without supervision, for users who have breathing difficulties.
•  It must never be used, without supervision, for users who cannot take care of themselves, either physically or mentally.
•  Do not use outdoors.
•  Do not use near an open flame.

Incidents

•  Incidents related to the use of Protac SensCircle® must be reported to the manufacturer
•  Serious incidents related to the use of Protac SensCircle® must be reported to the manufac-turer and the competent authority of the country where the incident takes place.

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 SensCircle® is designed as an aid for people with disabilities. Adults, youngsters and children can use Protac SensCircle®:

• Psychiatric illnesses such as schizophrenia, depression, anxiety, anorexia etc.
• Children and youngsters with sensory disturbance
•  ADHD and autism
•  Dementia problems, Alzheimers disease
• Brain damage, including Huntingtons disease, Parkinsons disease etc.
•  Developmental irregularities, deafness and blindness
•  Stress

Protac SensCircle® can be used for individuals suffering from psychiatric illness, who often experience motoric and mental unrest. Protac SensCircle® provides a sense of security. It encases and demarcates the body, making the user feel safe and calm. Protac SensCircle® can be used for elderly people in care homes, who may suffer from dementia. Protac SensCircle® provides a sense of security and can be positioned so that the user can lie down and relax. Protac SensCircle® can be used for the sensory stimulation of individuals with brain damage. Protac SensCircle® can be used for individuals with ADHD and autism, encasing them with the balls and providing them with the sensory stimuli necessary to create a sense of security and calm. Protac SensCircle® can be used for individuals with the likes of developmental irregularities, sensory disturbance and deafness and blindness to enhance sensory stimuli for the body and improve users’ body-awareness. Protac SensCircle® can be used for individuals with stress to give them calm, a sense of security and enhanced body-awareness. Protac SensCircle® can be used to promote a good night’s sleep. It helps calm down the central nervous system, because the user gets a sense of him/herself. Protac SensCircle® can be used in hospitals, care homes, institutions, residential facilities, daycare centres, common rooms and private rooms.

Use of the product

Protac SensCircle® consists of 3 modules and an outer cover. Each individual module is filled with 50-mm plastic balls or polypropylene granulate.
The uses of Protac SensCircle®include:

• Sitting up as a back support, for example in bed
•  A personalized reclining position
• Packing the body
•  Demarcating other other parts of the body
•  A chair
•  A cave
•  Lying on

Protac SensCircle® comes ready assembled.
The product’s service life 
The product has an expected service life of 3 years, though the polypropylene granulate modules have a service life of 2 years. The product’s lifetime is based on correct use, cleaning, washing, service and maintenance. Products that are used in excess of the above lifetime must be assessed for future use. The user is responsible for continuously assessing whether the product can be used in excess of the lifetime stated.

Cleaning

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. Both the outer cover for the Protac SensCircle® and the covers of the individual modules containing the balls are washable. The covers of the modules can be wiped with spirit. How frequently it needs washing depends on use. For washing and cleaning the Protac SensCircle®, please follow the instructions below.

•  The outer cover can be washed in a washing machine with a min. capacity of 7 kg, using washing powder without bleach. Also see the washing instructions in the cover.
• The modules can be washed separately in a washing machine in the wash bags supplied. Min. 16 kg using washing powder without bleach. Also see the washing instructions in the individual modules.
• The covers of the modules can be wiped with spirit.

Before using any stain removers, do a test on a non-visible area to make sure that it does not damage or change the colour of the fabric. Protac does not recommend the use of stain removers. Protac accepts no liability for damages resulting from incorrect washing and maintenance.

Taking apart prior to washing:

1. Zip open the outer cover and remove the 3 modules.
2.  Close the zip in the outer cover prior to washing.

Assembly after washing:

1. Zip open the outer cover.
2. Insert the 3 modules.
3.  Zip up the outer cover.

Spare parts:

• Outer cover
• Modules with 50-mm plastic balls
• Modules with polypropylene granulate

Maintenance

Every time you use Protac SensCircle® check for flaws and defects. Once a year inspect the seams, zip, fabric, filling and general condition. If you become aware of a serious flaw or defect, stop using your Protac SensCircle® until the flaw has been remedied and safety restored.

Transport and storage

For transport, the Protac SensCircle® is packed in a carrying bag and in a box to protect it against dirt and moisture. If the Protac SensCircle® is not in use, store it securely in the carrying case so that it is protected from dirt and moisture.

Disposal
Protac Sens Circles® can be divided into the following components for waste disposal purposes: Plastic and fabric. 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.

Warranty

There is a 2-year warranty for manufacturing defects

The warranty is void in the following instances:

• Overload of the Protac SensCircle®
•  Heavy-handed use of the Protac SensCircle®
• Lack of, or improper maintenance of the Protac SensCircle®

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

Technical specifications

• Dimensions and weight:
• Length/height:                                                                                             2.50/0.35 m
• Total weight – Oxford 3820 model with plastic balls and granules: approx. 4.5 kg.
• Total weight – Medley 2600 model with granules:                                        approx. 3.5 kg.
• Weight of outer cover:                                                                                approx. 1.0 kg.
• Weight per module with plastic balls:                                                          approx. 2.0 kg.
• Weight per module with granules:                                                              approx. 0.8 kg.

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: Tested in accordance with the standards stipulated in the table

The Protac SensCircle® contains 3 modules, filled with either EVA plastic balls or polypropylene granulate

Service information

Do not use balls in your Protac SensCircle® other than those used by the manufacturer.

Guide
– to daily inspection of the your Protac SensCircle® before use

Protac A/S
Kystvejen 17, 1.
DK- 8000 Aarhus C
Tel.: 86 19 41 03
e-mail: [email protected]
Distributor list: Please refer to: www.protac.dk/kontakt

References

• Protac.dk | Beroligende og sansestimulerende hjælpemidler med kugler