2021-04
Remarks
General Remarks
• Read the Instructions for Use carefully before first use. If you have difficulty reading, please have them read to you.
If the copy of the Instructions for Use is missing, you can download one from www.thomashilfen.de. The contents of
the digital Instructions for Use can be enlarged.
• Check the packaging for any transport damage and to be sure the product is in flawless condition.
• Changes to the product are only permitted within the scope of the intended adjustment options.
• Cleaning and daily care can be provided by relatives and caregivers. Maintenance and inspection are done by the
distributor.
• All labels have to remain on the product and should not be tampered with.
Exception: The maintenance label has to be updated and completed after each maintenance.
Safety Instructions
• Please do not overload the product and note the maximum user weight and the maximum load capacity (see techni-
cal data).
• The product should only be used by one user at a time. No other individuals should be placed in or on the product.
• All users have to be familiar with how the product works. This way in an emergency the user can be removed
quickly from the product.
• Heavy perspiration, high humidity, and extreme changes in temperature can have an impact on the foam in the mat-
tress. Pay attention to changes such as sagging in the mattress.
• If there is a serious and unexpected accident with the product, please inform our company immediately and the
responsible authorities.
Intended Purpose
Intended Use / Application Areas
The ThevoSleeping Star micro-stimulation system is a class 1 medical device.
The system is suitable for caring for sick children at home and in professional settings. It consists of a mattress and a
system of springs with the MiS micro-stimulation effect that promotes natural movement and the user’s body awareness.
The system allows users to lie a specific way; it can be complemented as required by other positioning aids. Adapters
can target and relieve pressure from vulnerable areas of the body. Special air channels in the foam core allow for very
good air circulation so that moisture can be removed. The micro-stimulation system is intended to treat and prevent
pressures sores and to reduce pain caused by lying down.
The system replaces a standard mattress and goes into existing bed frames with the reclining surface and is also used in
beds in care settings. The adjustment options of the existing bed frame are not limited by the micro-stimulation system.
The system does not replace manually changing positions, but the system can lengthen the lying intervals. It is suitable
for use in combination with digital assistance systems in care settings.
Any use that goes above and beyond this does not comply with the intended use.
Indication / Patient Target Group / Intended Users
The micro-stimulation system is suitable for children and adolescents with limited mobility and / or impaired body
awareness, circumstances that adversely impact changes or shifts to body position. Furthermore, the product is used if
the user has or is at risk of having pressure sores on the skin and subcutaneous tissue, such as on the back, buttocks, or
heels. It is especially suited to children who should be encouraged to move more on their own when lying down.
This can definitely be used if there are illness-related difficulties falling asleep and sleep disturbances and impaired body
awareness during sleep.
Instructions for Use –
Thevo
Sleeping Star
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