Starck Sefam S.Box, Service Manual, Page: 33 / 56

Sefam S.Box Technical characteristics  33
On the packaging: this symbol
means "Fragile" because the
package must be handled with
care. On the packaging: this symbol means
"Keep dry" because the package
must be protected against moisture
and water.
On the packaging, this symbol
means "Temperature limit".
Refer to the user manual.
CE marking
Date of CE marking of SEFAM S.Box®: 2017
Regulatory Requirements
Risks concerning this medical device are evaluated according to the ISO 14971 standard, specifically
with regard to global residual risk.
The SEFAM S.Box
®
complies with the following Directives and standards:
 Directive 93/42/CEE of the European Parliament and of the Council concerning medical devices,
modified by the European Directive 2007/47/CE
 Directive 2014/53/EU of the European Parliament and of the Council on the harmonization of the
laws of the Member States relating to the making available on the market of radio equipment
 Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use
of certain hazardous substances in electrical and electronic equipment (RoHS)
 Directive 2012/19/EU of the European Parliament and of the Council on waste electrical and
electronic equipment (WEEE)

Federal Aviation Administration RTCA/DO-160G section 21 category M

IEC 60601-1:2005 + AC1:2006 + AC2:2007 + Amd1:2012: Medical electrical equipment. Part 1:
General requirements for basic safety and essential performance

IEC 60601-1-2:2014: Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests

IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests

ISO 80601-2-70-1:2015: Medical electrical equipment -- Part 2-70: Particular requirements for
basic safety and essential performance of sleep apnea breathing therapy equipment

EN ISO 8185:2009: Respiratory tract humidifiers for medical use -- Particular requirements for
respiratory humidification systems
End of life disposal of the device
In European Union this device has to be considered as an electrical and electronic piece of
equipment as defined in Directive 2012/19/EU, and must be collected and processed separately from
household waste for disposal as indicated by the symbol of the crossed out garbage bin (see
"Definition of symbols").
In other countries, this device must be processed following local regulation.
Unsuitable disposal of the device at the end of its life could harm the environment.