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Infant Flow SiPAP
675–101–101 Rev. P
Intended Use Notice
The Infant Flow nCPAP System, consisting of the Infant Flow SIPAP Driver and
Generator assembly plus NCPAP Prongs and Masks, is intended for the provision of
nasal CPAP and BiPhasic CPAP (SiPAP) to produce a sigh. Nasal CPAP should
only be used on a spontaneously breathing infant. The system is for use in hospitals,
hospital-type facilities, and intra-hospital transport environments and is indicated for
the treatment of newborn and infant patients. The Infant Flow SiPAP driver should
only be operated by properly trained clinical personnel, under the direction of a
physician.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
Reuse of single-patient use accessories may degrade the performance of the
product or cause cross contamination.
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.
Summary of Contents for Infant Flow SiPAP
Page 1: ...Infant Flow SiPAP Operator s Manual ...
Page 10: ...x Infant Flow SiPAP 675 101 101 Rev P Electromagnetic Environment Specifications ...
Page 11: ...Infant Flow SiPAP xi 675 101 101 Rev P ...
Page 14: ...xiv Infant Flow SiPAP 675 101 101 Rev P Infant Flow SiPAP ...
Page 20: ...6 Chapter 2 Product Specifications 675 101 101 Rev P Infant Flow SiPAP ...
Page 38: ...24 Chapter 5 Operation 675 101 101 Rev P Rear Panel Figure 8 Rear Panel ...
Page 48: ...34 Chapter 5 Operation 675 101 101 Rev P Infant Flow SiPAP ...
Page 64: ...50 Appendix A Product Configurations 675 101 101 Rev P Infant Flow SiPAP ...
Page 65: ...Infant Flow SiPAP 51 675 101 101 Rev P Appendix B Pneumatic Diagram ...
Page 66: ...52 Appendix B Pneumatic Diagram 675 101 101 Rev P Infant Flow SiPAP ...
Page 70: ...56 Appendix C Alarm Troubleshooting 675 101 101 Rev P Infant Flow SiPAP ...
Page 76: ...62 Appendix D Fault Management 675 101 101 Rev P Infant Flow SiPAP ...
