SEFAM EcoStar, Practitioner And Home Care Provider Manual, Page: 19 / 26

EcoStar Technical characteristics

19
Maximum flow
(According to ISO 17510-1:2009, Appendix CC.1)
Test pressure (cmH
2
O)
4 8 12 16 20
Without humidifier :
Maximum flow (l/min) provoking a
pressure drop of 1
cmH
2
O at the
opening of the patient side connection
> 105.0 > 159.0 167.0 144.0 132
With GoodKnight H
2
O humidifier :
Maximum flow (l/min) provoking a
pressure drop of 1
cmH
2
O at the
opening of the patient side connection
48 47 45 44 43
Sound pressure level measured in accordance with NF EN ISO 17510-1:2009:
26 dB(A)
Sound power level measured in accordance with NF EN ISO 17510-1:2009:
34 dB(A)
Standards Compliance
Risks pertaining to this medical equipment were assessed in accordance with the ISO 14971: 2007
standard, specifically with reference to global residual risk.
The EcoStar device complies with the following directives and standards:
 IEC 60601-1:2005 + 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.
 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.

NF EN ISO 5356-1:2005 : Anaesthetic and
respiratory equipment. Conical connectors.
 Council Directive 93/42/EC concerning
medical equipment.
 European Parliament and Council Directive
2011/65/EC on the restriction of the use of
certain hazardous substances (RoHS) in
electrical and electronic equipment.

European Parliament and Council Directive
2012/19/EC on waste electrical and
electronic equipment (WEEE).