Idiomas disponibles
Idiomas disponibles
5. Classification according to Medical Devices Directive 93/42/EEC
Medical Devices are classified into Class I, IIa, IIb and III. Classification is set out in Annex IX of
Directive 93/42/EEC and its amendment 2007/47/EC according to the following general rules.
Rule 9 says:
All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their
characteristics are such that they can manage the human body energy exchange with the same potentially
hazardous way, taking into account the nature, the density and point of application of energy, in which
case they were in class IIb. All active devices intended to control the operation of active therapeutic
devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.
According to that Annex, the Hubbard tank is Class I by Rule 9.
Classification with EN 60601-1:2006 (6)
According to point 6.2 is Class I
According to point 6.3 is IPX0
According to point 6.6 is Working mode= continuous
Fulfilling with 60601-1:2006 (7.2, 7.9)
According to point 7.2.2. the product is clearly identified in 4.1 and 4.2 of this document. In 12.4 you
can find the label that will finally appear in the product. The label is the same than for all models with the
only difference of model number and electrical features.
According to 7.2.3 the symbol
According to point 7.2.6.the product is clearly marked. The symbol
12.4 you can find the label that appears in the product. The label is the same than for both models with the
only difference of model number and electrical features. The unit shows a label in the same part of the
mains connection with this information:
230 V
115 V
50 Hz
2A
According to 7.2.6 the symbol
According to 7.2.10 the symbol
According to 7.9.2.15 it is clearly stated that:
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There is no risk when the product reaches the end of the life cycle. Materials are Inox Steel for the major
part of the product. No materials or components could damage to people or goods.
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Ortotecsa always suggest to get in contact with the Wastes Management Entities in your country to
dispose correctly the product when it is in the end of the life cycle
According to 7.9.2.16 it is clearly stated that:
Classifications and markings: please see 5
6. Operator skills and training
SKILLS
Operators using the tank need:
To have knowledge and experience of aquatic physical-therapy procedures.
The ability to assist the patient.
TRAINING
Operation and maintenance manual Rev2
when it is necessary in the document
60 Hz
2A
is used in the labels on products. See 12.4.
appears in the external surface of product in a label like this
is used in the labels on products. In
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