| Introduction
In institutional care, the use of a restraining belt is a method
of treatment used when nothing else works, when the issue is the safety
of the patient as well as of others. This is the foundation and the basis of the design of the belt system TRYGGER. TRYGGER is a professional, approved belt system, manufactured in Sweden. Belts and similar devices intended for patient restraint in institutional care are, according to the Swedish Medical Products Agency, considered Medical Devices, and must comply with the requirements of LVFS 2003:11 based on EU directive 93/42/EEG. Medical devices, such as restraining belts and similar devices must have a CE marking. TRYGGER meets all these requirements and of course has the CE mark. TRYGGER is today the only belt system approved by the Swedish Medical Products Agency, manufactured in Sweden for use in institutional psychiatric care in Sweden. Today the belt system TRYGGER is the most frequently used system within institutional psychiatric care in Sweden and is used by several Swedish hospitals, such as St Görans Hospital, Stockholm, Karolinska University Hospital, Huddinge, Ulleråker Hospital, Uppsala, Sahlgrenska University Hospital, Göteborg, and others. The belt system TRYGGER is tested by SP, the Technical Research Institute of Sweden, where the system was submitted to a number of pulling tests and the tests showed high durability. The product is registered with the Swedish Medical Products Agency as a medical device, grade 1. The belt system TRYGGER is patented and the design is protected by the Swedish Patent and Registration Office. TRYGGER is marketed as TRYGGER 1 or TRYGGER 2,
the difference is the placing of the foot straps. It is also marketed
as TRYGGER-MOBIL, intended for transport/transfer of patients.
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