CareFusion Infant Flow LP SiPAP, Service Manual

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Service Manual
ix
675-120 Rev. G
Intended Use Notice
The Infant Flow
®
LP SiPAP system, consisting of a Driver and Generator plus
NCPAP Prongs and Masks, is a medical device intended for the provision of Bi-Level
CPAP to produce a sigh. This system is for use in Hospital, Hospital Type facilities
and intra-Hospital transport environments and is indicated for the treatment of
Newborn and Infant patients.
Operators of this equipment and Service Engineers are required to read and thoroughly
understand the contents of this manual before using or maintaining the equipment.
This manual is intended for use by a competent, fully qualified Service
Engineer. It includes a description of the unit and how it works. It also contains
operating and diagnostic procedures and maintenance instructions. For usage
of associated equipment, refer to the Manufacturer’s literature.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
Classification
Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1
Protected, and uses type BF applied parts. Equipment is not suitable for use in
presence of flammable anesthetics.