Service manual

10 Infant Flow
®
SiPAP
675-120 Revision D May 2005
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and
the following Technical Standards, to which Conformity is declared:
Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4)
Safety: EN 60601-1, EN 794-1
EMC: EN 60601-1-2:2001
Conformity Assessment: MDD Annex II
Quality System: ISO 13485
EU Notified Body: BSI (Reg. No. 0086)
Device Classification: IIb
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
Infant Flow SiPAP
Manufactured by:
SensorMedics Corporation
22745 Savi Ranch Parkway
Yorba Linda, CA 92887, USA
If you have a question regarding the Declaration of Conformity for this product,
please contact VIASYS Healthcare, Respiratory Care.