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Our aim has been to develop a float-system that would meet the strict European
regulations in order to guarantee safety above all.
Yet, the Koan Float-System is not only marked with CE but has been approved as
a medical therapeutical aid as well.
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Means of conformity
Electrical safety i.a.w. EN/IEC 60601-1 Medical Electrical Euipment Part 1,
Amendment 1 and Amendment 2, Class I type B
EMC 92/42/EEC and 89/336/EEC
Immunity: Conform EN/IEC 60601-1-2
ESD EN/IEC 61000-4-2
RF EN/IEC 61000-4-3
Transients EN/IEC 61000-4-4
Surges EN/IEC 61000-4-5
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The Koan Float-System meets the following European regulations:
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The directive govering medical aids: Medical Devices and Equipment 93/42/EEC |
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The low voltage directive: EMC Directive 89/336/EEC |
Emission: Conform EN/IEC 60601-1-2
Conducted EN/IEC 55011 CISPER 11 Group 1 Class B
EN/IEC 55014 CISPER 14 Quasi peak average
Rafiated RF EN/IEC 55011 Group 1 Class B Quasi peak
The Koan Float-System is provided with a CE Mark
Additional documentation:
Omegam:
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"General guidelines regarding the waterquality of Floataria" , Omegam, 11
December 1998, projectno. 22.0.72231 |
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"Risk Analysis in connection with legionella bacteria in Floataria" , Omegam,
24 March 1999, projectno. 22.0.98135 |
TNO:
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"EMC test according to EN 60601-1-2/IEC 60602-1-2 on the Koan Float-Tank", TNO
Prevention & Health, 1 July 1999, PG/TG/99.047 |
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"EN 60601-1/IEC 60601-1 compliance test on the Koan Float-Tank"
, TNO Pevention & Health, 28 January 2000, PG/TG/99.037 |
Protonic:
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"EMC testreport" , Protonic, 12 January 1999, project P4890 |
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"Analyse beveiligingen in hard- en software t.b.v. de besturing voor de floatcabine",
Protonic, 5 March 1999, Projectno. P4890 |
The Koan Float-System has been developed in conjunction with:
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Syntens : General advises |
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National Aerospace Laboratoy: Advices with reference to the development of
the electrcal control system. |
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TNO Prevention & Health, notified body for medical devises: Inspections,
testing end advises with reference to the entire system. |
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Omegam: research and advises with reference to the quality of water. |
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Protonic : Development of the electronical control system |
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