gk-medizinmechanik GK Hera, User Manual

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9
Intended use / Standards & regulations
■ Intended use
Bathing system for bathing patients with restricted mobility. The
bathing system is mainly used in care institutes, to a lesser de-
gree also on hospital wards. It is used in a professional environ-
ment by trained and competent personnel.
■ Standards & regulations
The bathtub complies with the essential requirements pursuant to
Appendix I of the Medical Device Directive 93/42/EEC.
In accordance with the classification regulations pursuant to Ap-
pendix IX of the Medical Device Directive 93/42/EEC, the bathtub
is a Class I medical device.
ISO 9001
Our production is subject to a quality management
system according to ISO 9001.