PROTAC SenSit Healthcare Chair Instruction Manual

PROTAC SenSit Healthcare Chair

Protac SenSit®

You have chosen a Protac quality product. Protac guarantees that you have purchased an original Danish designed product developed in partnership with professionals. Since 1994, Protac has developed, manufactured and sold sensory stimulating aids to the healthcare sectors in Denmark, Europe, Australia and New Zealand.
Protac products are developed from the theory of sensory integration and are well documented with respect to research, documentation and case descriptions.
Protac production process focuses on environment and safety. Protac plastic balls are certified STANDARD 100 by OEKO-TEX® nr. 2076-310 DTI.

For more information, go to www.protac.dk – includes instructional video on how to change the cover.

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 chair.
Symbol explanation on label: see the Key to symbols section

General precautions – Safety

• Please pay attention to the reaction of the user, if he or she does not like being encased in the chair’s neck and side wings.
• Make sure that the user does not overheat if he/she is embraced by the chair’s neck and side wings.
• Users with poor breathing must use the side and neck wings with care and never unsupervised.
• The chair must not be used unsupervised with individuals who require special care.
• Check to see whether any balls might be irritating the user. This is particularly important if the user is incapable of independent movement.
•   The chair must not be used by individuals with bedsores.
• You must not retrofit the chair with loose parts: for example, straps and belts.
• Make sure that children and other users do not get their hands and feet caught in the carrying straps.
• Protac SenSit® is not designed for outdoor use.
• Protac SenSit® may only be used by individuals with a maximum weight of 200 kg.
• Only original stand, Protac SenSit® Frame may be used.
• Avoid smoking in the chair. Lost embers or cigarettes can cause burns.
• Never leave a turned on computer or other electrical devices in the chair as they generate heat which may cause the cover to deteriorate, or in the worst case cause the electrical unit to ignite as the heat cannot escape.
• Must not be used near an open fire.

Incidents

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

Purpose and function of the product

All Protac products are developed from the theory of sensory integration. The theory originates in the USA and was developed by occupational therapist and psychologist A. Jean Ayres back in the 1970s. The theory is based on how the brain processes sensory impressions and how the different sensory stimuli can be influenced through weight and pressure on the tactile sense (sense of touch) in the skin and the proprioceptive sense (sense of movement) in muscles and joints. The pressure, movement and weight of the balls stimulate these particular senses.

The Protac SenSit® chair was developed as an aid for individuals with functional impairments.
The Protac Sensit® chair is suitable for children, youths, adults and the elderly.

• Brain damage, including spasticity, Huntington’s chorea, Parkinson’s disease etc.
• ADHD and autism
• Mental illnesses such as dementia, schizophrenia, depression, anxiety, anorexia etc.
• Developmental disorders, sensory disruptions, deaf-blindness etc.
• Stress

The Protac SenSit® chair is used to give relief or as a supplement for individuals with brain damage who are wheelchair users or bedridden. The chair’s stable shape supports the neck, head and body, and the balls in the seat and back make it easy to adjust the chair and create a comfortable sitting and resting position.

Individuals with ADHD and autism can use the Protac SenSit® chair as a ‘contained space’ where the user is surrounded by the balls and receive the sensory stimuli needed to ensure calm and a sense of security. The chair can be used to eliminate sensory impressions so that the user can concentrate on school homework for example.

Individuals with mental illness often suffer from motor and mental restlessness. The Protac SenSit® chair can be used as a ‘safe place’ to ensure calm and a sense of security for the user. Weight and pressure of the balls also lead to better body awareness and improved well-being.

The Protac SenSit® chair is used for individuals with for example developmental disorders, sensory disruption and deaf-blindness in order to increase the body’s sensory stimulation.

The Protac SenSit® chair is used for individuals with stress to ensure calm and a sense of security as well as better body awareness.

The Protac SenSit® chair can be used in institutions, care facilities and hospitals, for example in common rooms or private rooms. In schools the SenSit chair can be used in the class room, in the library or in common rooms. In private homes the SenSit chair can be used in the user’s room or in the living room.

Using the product

The Protac SenSit® is delivered fully assembled and ready for use

Product lifetime

The product’s expected lifetime is five 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

It is recommended to clean and wash the covers as the Protac SenSit® chair may become dirty over time. The need and frequency of washing depend on the use of the chair.
Follow the instructions below when washing and cleaning the chair.

• The cover can be washed in a washing machine, min. 7 kg, using a detergent without bleach and perfume. Fabric softener must not be used. See the washing instructions inside the cover.
• The seat cover with incontinence fabric on the reverse side, can be unzipped and washed separately using a detergent without bleach and perfume. Fabric softener must not be used. See the washing instructions inside the cover.
• Neck and side wings can be washed in a washing machine, min. 7 kg, using the supplied washing bags. Use detergent without bleach and perfume. Fabric softener must not be used. See the washing instructions inside the wings.

Instructions before wash:

1. Remove the innerbag from the neck support.

2. Remove the ball bags from side-/ neck wings. The ball bags must be washed separately.
   The included laundry bag must be used.

3. Zipp off the seat cover.

4. Detach the inner bag, with balls and granulate, from the velcro in the back and take it out of the chair.

5. Zipp off the bottom cover.

6. Unzip the chambers for the back and front-foam plates at the bottom.

7. Remove the front and back foam plates.

8. Close all zippers. Zipp seat / bottom covers to the cover, before washing.

Assembly after wash:

1. Unzip the seat and bottom cover.
2. Unzip the front foam plate chamber.
3. Insert the front foam plate in the chamber, remember to turn the side with the plastic plate inward. Close the chamber with the zipper.
4. Unzip the chamber for the back foam plate.
5. Insert the back foam plate in the chamber, remember to turn the side with the plastic plate inward. Close the chamber with the zipper.
6. Zip on the bottom cover
7. Place the innerbag inside the cover. Make sure the velcro pieces fit at the back
8. Zip on the seat cover. Attach the velcro on the seat cover to the velcro on the inner bag.
9. Insert the innerbag in the neck support, the ball bags for neck and side wings in the chambers. Closes with zipper. Remember to attach the ball bags to the neck and side wings inside with velcro.

Find video showing how to assemble the SenSit chair at: www.protac.dk

Please note! This is a job for two people!

Before using any stain removers, do a test on a non-visible area (bottom of chair) 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.

• Do not wash the inner bag with balls and granulate
• Do not wash the inner bag in the neck rest

Maintenance

Over time a recess will form in the seat as the granulate at the bottom ‘settle’ through use. It is therefore important to turn the chair upside down once in a while and shake it a little to allow the granulate to become evenly distributed again. This will restore the shape of the seat. Inspect the chair for defects and deficiencies prior to each use, and inspect the chair’s seams, zips, fabric, straps, balls and general condition once a year. If serious defects or deficiencies are discovered, the Protac SenSit® chair must not be used until the defects have been repaired and safety has been restored.
The Protac SenSit® can be wiped with a well-wrung cloth soaked in warm soapy water. Can be wiped off with alcohol.

Transport and storage

It is easy to move the Protac SenSit® chair using the two carrying straps fitted on each side of the chair.

During transport, the chair is wrapped in protective plastic in a cardboard box, which protects the chair against dirt and moisture.
The chair must be stored in a safe place when not in use, preferably covered to protect it against dirt and moisture.

Disposal

Protac SenSit® 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 two-year warranty against manufacturer’s defects.

The warranty will be voided in the following cases:

• Overload of Protac SenSit®
• Harsh use of Protac SenSit®
• Lack of or incorrect maintenance of Protac SenSit®

Accessories

• Protac SenSit® Puff
• Protac SenSit® Frame
• Protac SenSit® Incontinence cover
• Protac SenSit® Carry bag

Protac SenSit® Incontinence cover

Use of the product

The incontinence cover is pulled over the inner bag

General Precautions – Safety

When using the incontinence cover, the same risk regulations apply as when using a plastic bag.

• Incontinence covers are dangerous toys for children

Cleaning

• Incontinence covers can be washed in a washing machine min. 5 kg. at max. 90⁰ with detergent without bleach and perfume – see washing instructions in the incontinence cover.

Protac SenSit® Puff

Protac SenSit® Puff is a foot/leg rest that may be used together with the Protac SenSit®.

Use of the product

General precautions – Safety

• Must not be used unsupervised with individuals who require special care.
• Must not be used by individuals with pressure ulcers on their calves and heels
• Take care not to trip over the footstool if the user is unsure of his/her balance.
• Do not use to sit on if you have decubitur.
• Do not place on a plate with wheels.
• Avoid smoking when sitting on the Puff.
• Must not be used near an open fire.
• May only be used as a stool by individuals with a maximum weight of 150 kg

Cleaning

• The cover can be washed in a washing machine, min. 7 kg, using a detergent without bleach and perfume. Fabric softener must not be used. See the washing instructions inside the cover.

Protac SenSit® Frame

Protac SenSit® Frame is a stand specially made for Protac SenSit® . The stand makes it easy to get up from the chair, while at the same time adjusting the seat height.

• The wheels must be locked when a person is sitting in the SenSit chair.
• Do not move around when a person is sitting in Protac SenSit® .
• When using Protac SenSit® with the Protac SenSit® Frame, the chair must be placed
  correctly in the Frame stand.

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
| Manufacturer
| Batch number

Spare parts

• Banana-shaped cushion with granulate
• Cover for chair
• Foam plate for back
• Foam plate for front
• Innerbag with balls and granulate.
• Ballbags for neck- and side wings
• Innerbag for neckrest

Technical specifications

Dimensions:

Protac SenSit®| Back height: 78 cm.| diameter: 90 cm.| weight: approx. 22 kg.
Protac SenSit®| Back height: 85 cm.| diameter: 90 cm.| weight: approx. 23 kg.

Patent: Protac SenSit® is 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.

Crash test: EN15377: 2007
Ignitability test: EN1021- 1 and 2:2014

Service information

Only the balls used by the manufacturer may be used in the Protac SenSit® chair.

Guide

– to daily pre-use inspection of the Protac SenSit® chair

1

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• All parts are in place, no loose parts. (wings and neck pillow)

|

2

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• Straps are not loose, seams are OK.

|

3

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• Straps are not loose, seams are OK.

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4

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• Seat height is OK (no sinking of the seat)

|

5

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• No sign of holes or damage to the fabric and seams

|

Customer Support

Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Tel.: +45 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

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