48
49
5 features
features
5.11 Protection
Electrical protection by two delayed action fuses, 6.3 x 32mm ceramic: T16A
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Protection against AC overvoltage and microcuts.
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Thermal protection by thermal switch, 125 °C +/- 5 on pumps.
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Thermal protection on power supply.
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Protection Index: IP 20
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Motor insulation class: Class B
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5.12 Maintenance
cleaning:
Cleaning the outside of the device:
Damp sponge and rag with a household cleaning product
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without alcohol.
Cleaning treatment heads:
Wipes soaked in an antiseptic, bactericide, and fungicide solution.
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Avoid alcohol-based products.
Maintenance Frequency:
Replacement of filter cartridges:
When the warning message appears.
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Replacement of Lift head flaps:
When the flaps no longer treat the skin properly, they should be
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replaced. They should be replaced approximately every 14 hours.
5.13 MiScellaneouS
Available color: White
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Noise level at 1 meter (indicative values, not normalized):
Without sequentiality: 50 dB A
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With sequentiality: 60 dB A
Degree of impurity filtration: 5 µm
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Product identification by individual serial number located on the identification label.
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Product traceability by individual manufacturer sheet.
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INPI-registered model (Institut National de la Propriete Industrielle)
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5.14 aPPlicaBle directiVe & StandardS
Electrical protection class:
Class 1
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Applicable European Directive:
93/42/EC. MDD
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Medical device (class IIa, rule 9) marked CE under Appendix V of the directive
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IEC 60601–1 standards and collateral EMC, Usability and Risk Management standards
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DEEE 01 and 02 (RoHS)
Labeling, graphical symbols:
ISO15223-1; EN980; EN1041
Risk Management:
ISO14971
FMEA IEC60812
Biocompatibility:
ISO10993-5/-10
Clinical trials:
ISO 14155-1/-2
Quality Management System: ISO9001, ISO13485, ISO13485 CMDCAS, FDA QSR,
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configuration and maintenance menus
6 configuration and maintenance menus
6 .1
introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6 .2
changing the language . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6 .3
date and time adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6 .4
preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6 .5
changing the filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6 .6
software updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6 .7
periodic locking function . . . . . . . . . . . . . . . . . . . . . . . . . . 53
6 .8
system information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6 .9
maintenance access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
a) machine state tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
b) unitary tests screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
c) functional tests tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
d) setup tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
6 .10
error management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
