Electromagnetic Compatibility - MolecuLight i:X Manual Del Usuario

2.2.4 Symbols Used for MolecuLight DarkDrape Label
The following table lists the symbols and statements used on the MolecuLight DarkDrape label.
Symbol Source & Meaning
Source: ISO 15223-1:2012
Meaning: Catalog number
Source: ISO 15223-1:2012
Meaning: Batch code
Source: ISO 15223-1:2012
Meaning: Date of manufacture
Source: ISO 7010:2011
Meaning: Read User Manual
Source: ISO 15223-1:2012
Meaning: Caution, consult
accompanying documents
Table 4: Symbols and statements on the MolecuLight DarkDrape label
2.2.5 Symbols Used for MolecuLight DarkDrape Package Label
The following table lists the symbols and statements used on the MolecuLight DarkDrape packaging label.
Symbol Source & Meaning
Source: ISO 15223-1:2012
Meaning: Catalog number
Source: ISO 15223-1:2012
Meaning: Batch code
Source: ISO 15223-1:2012
Meaning: Date of manufacture
Source: ISO 7010:2011
Meaning: Read User Manual
Source: ISO 15223-1:2012
Meaning: Fragile
Source: ISO 15223-1:2012
Meaning: Caution, consult
accompanying documents
Table 5: Symbols and statements on the MolecuLight DarkDrape package label (10-pack and 50-pack)
2.3 Certifications
The MolecuLight i:X Imaging Device complies with the following standards:
Safety Testing per IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013
including Canadian National Differences per CAN/CSA-C22.2 No. 60601-1:14 and
US National Differences per ANSI/AAMI ES 60601-1:2005/A1:2012
Safety EMC Testing per IEC 60601-1-2:2007 3rd Edition including FCC Part 15 Subpart B: 2015 & ICES-003:2012 / EN
60601-1-2:2007
Safety LED testing per IEC 60601-2-57:2011 and IEC 62471:2006 / EN 60601-2-57:2011 and EN 62471:2008
Usability Testing per IEC 60601-1-6:2010+A1:2013 / EN 60601-1-6:2010 and EN 62366:2008
TM
MolecuLight i:X User Manual Revision 1.0
Symbol Source & Meaning
Source: ISO 15223-1:2012
Meaning: Do not use if package is damaged
Source: ISO 15223-1:2012
Meaning: For single use only
Source: ISO 15223-1:2012
Meaning: Non sterile
Source: IEC 60417 – 5840
Meaning: Type B applied part
Source: European Conformity Marking
Meaning: Manufacturer's declaration that the
product meets the requirements of the applicable EC
directives
Symbol Source & Meaning
Source: ISO 15223-1:2012
Meaning: Keep dry
Source: ISO 15223-1:2012
Meaning: Do not use if package is damaged
Source: ISO 15223-1:2012
Meaning: For single use only
Source: ISO 15223-1:2012
Meaning: Non sterile
Source: IEC 60417 – 5840
Meaning: Type B applied part
Source: European Conformity Marking
Meaning: Manufacturer's declaration that
the product meets the requirements of the
applicable EC directives
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Risk Management per ISO 14971:2007 / EN ISO 14971:2012
Quality Management System Requirements per ISO 13485:2003 / EN ISO 13485:2012
The MolecuLight DarkDrape complies with ISO 10993-1:2009 / EN ISO 10993-1:2009: Biological evaluation of medical
devices.
2.3.1 Classifications
MolecuLight i:X has an operational duty cycle of 15 minutes on, 5 minutes off. The implication for this duty cycle is that if
the MolecuLight i:X is continuously used in Fluorescence Imaging Mode for 15 minutes, the device will need to be switched
to Standard Imaging Mode for 5 minutes before selecting Fluorescence Imaging Mode again to allow for optimal
performance of the Violet Wavelength LEDs.
The medical device classification of the MolecuLight i:X in Canada is Class II medical device and a Class IIa medical device in
Europe. Alone, the MolecuLight i:X does not require patient contact for use. The MolecuLight DarkDrape (used in
combination with the MolecuLight Adapter and MolecuLight i:X to achieve an optimal lighting environment for imaging
wounds) is a Type B patient applied part which complies with medical device biocompatibility requirements.
The MolecuLight i:X is classified as "IPX0" for fluid ingress, therefore it has no inherent protection against damage from
exposure to liquids.

2.4 Electromagnetic Compatibility

The MolecuLight i:X Imaging Device meets the requirements of IEC 60601-1-2:2007 3
Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be used
according to the instructions in this User Manual.
While unlikely, it is possible that high levels of emitted radio-frequency (RF) electromagnetic interference (EMI) from other
portable and mobile RF communications equipment or nearby radio-frequency sources could result in performance
disruption of the MolecuLight i:X Imaging Device.
To avoid the risk of increased electromagnetic emissions or decreased immunity from such emissions, use only accessories
recommended by MolecuLight (i.e. MolecuLight Power Cable, see Section 3.1). Connection of accessories not recommended
by MolecuLight will void product warranty and could result in malfunctioning of the MolecuLight i:X Imaging Device or other
devices located in the area.
This device complies with Part 15 of the US FCC Rules. This device complies with Canadian ICES-003 (B).
2.5 Information on Laser Radiation Output
The MolecuLight i:X Imaging Device uses a miniature pulsed laser-based range finder to determine the optimal distance
between the device and the wound for superior image quality. The laser module in the range finder emits light at 850 nm
which is invisible to the human eye. The laser's individual pulse duration is 3.33 ns and the pulse train is 52.3 ms at a 200 ms
repetition rate. The laser complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.50.
The laser is a Class 1 certified laser
Caution Do not point the laser (from the Range Finder sensor) into eyes (Figure 2, item 14).
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MolecuLight i:X User Manual Revision 1.0
rd
edition / EN 60601-1-2:2007.
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