Care Fusion Infant Flow SiPAP User manual

Infant Flow™SiPAP
Operator’s Manual

ii Infant Flow SiPAP
675–101–101 Rev. P
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CareFusion
22745 Savi Ranch Parkway
Yorba
Linda, CA 92887
U.S.A.
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Leibnizstrasse
7
97204 H
oechberg
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.283.2228 tel
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8493 fax
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[phone].
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carefusion.com
Literature number: 675–101–101 Revision P

Infant Flow SiPAP iii
675–101–101 Rev. P
Revision History
Date
Revision
Changes
September 2003 675-101(3) Release
August 2004 D Release manual in VIASYS Respiratory Care template using
VIASYS Respiratory Care nomenclature. Revise part number
list in Appendix B approved accessories.
November 2004 E Revised contact/ordering information.
Ch 4. Sec. 5.b revised transducer LED illumination conditions.
Appendix A corrected units from "Pm" to bpm.
Appendix E added dimension ranges to bonnet sizes.
Appendix E Was 467350 Transducer Assembly Is: 677-002
Transducer Interface.
March 2005 F Updated the contact information.
Updated the Declaration of Conformity Notice.
May 2006 G Updated the company name.
Updated the Contact and Ordering Information.
Update the figures.
Added a Caution regarding back pressure. Added a Note
regarding the Hudson RCI Humidification System.
Added the sentence “Ensure there is a minimum 8 LPM set
on the NCPAP/PRES Low Flow meter” to the first paragraph
under “Two Point O2Sensor Calibration.
Changed step 8 regarding the nCPAP pressure.
Changed the second and third paragraphs under Changing a
Control.
Added “Setting a Manual Breath.”
Added a note regarding the enabling of manual breath or back-
up apnea breath.
Added a warning concerning infant flow consumables.
Added the statement “Disconnect the air and oxygen gas
sources when the Infant Flow SiPAP is not in use.”
Removed Appendix E.
February 2009 H Changed Ti to T-High and Inspiratory Time to Time High.
Replaced reference to VIASYS Respiratory Care accessories
with reference to Cardinal Health accessories.
Added “TM” superscript to “SiPAP”.
Added reference to AirLifeTM Infant nCPAP System Generator.
Removed “inspiratory time” or “inspiration time”.
Replaced “Inspiratory Time (Time High)” with “Time High

iv Infant Flow SiPAP
675–101–101 Rev. P
Date
Revision
Changes
(Thigh)”
Changed 1 cmH2O to 1.5 cmH2O; Added “or 60 psi” to clarify 4
bar.
Added the parts list for both Infant Flow Products and AirLifeTM
Products.
Added reference to Cardinal Health contact information on page
v.
Added reference to AirLife™ Infant nCPAP System accessories.
Added a warning about using an external oxygen monitor.
Added reference to factory trained technician and Service
Manual P/N 675-120.
Added “®” (registered symbol) superscript to Infant Flow.
Updated CAUTION label: from “Back pressure from the
humidifier chamber to some auto-feed water bags may occur.”
To “Back pressure from some auto-feed humidifier chambers
may cause the water bags to fill with air.”
Replaced Figure 5.
Add content concerning a depleted or damaged internal oxygen
cell.
Added a warning about using an external oxygen monitor.
Added content to explain fault code E5X.
Replaced “key” with “button”; clarified oxygen alarm by adding
“the audible”; added clarification of the internal monitoring being
disabled and that an external oxygen monitor must be used.
Added a Note regarding the 2
nd
Flow Meter being used for
manual breath delivery;
Added hyphen in “T-High”.
Clarified the “Mode Select Screen”
Added “Directions for using the AirLife™ Infant nCPAP System.
Changed 1 cmH2O to 1.5 cmH2O; Corrected low battery voltage
level from 10 to 11.10.
Added “or trained biomedical engineer”.
Added a table entry for the oxygen monitor and alarms disable.
Changed 1 cmH2O to 1.5 cmH2O; corrected low battery voltage
level from 10 to 11.10.
Updated Table 10.
Updated Table 11.
Clarified the meaning of T-High.
February 2010 J Revised to comply with the revised Medical Device Directive
2007/42/EC.

Infant Flow SiPAP v
675–101–101 Rev. P
Date
Revision
Changes
March 2010 K Rebranded the manual to the CareFusion style.
Updated the part number table.
January 2011 L Changed the logo and company references to VIASYS.
January 2011 M Changed the logo and company references to CareFusion.
March 2013 N Corrected the pneumatic supply range specification.
Corrected the atmospheric and environmental storage
specification.
June 2013 P Removed TM from SiPAP.
Changed ® to TM for the name Infant Flow.
Updated the address information to include symbols.
In the “Flow/Pressure Relationship” section, added the Flow
pressure nomogram for the Infant Flow LP generator.
In the Leak Test procedure, step 4, added “(for the Infant Flow
LP generator, adjust the flow meter to 9 L/M).”
In the “Alarms Test” section, in the Alarm Test Initial Settings
table, added “Infant Flow LP: 9L/min (for delivery of 5 cmH2O)”
to the NCPAP / Pres Low flow meter specification.
Updated figures to remove references to VIASYS.
Corrected the Intended Use Notice.
Added the “SiPAP Gas Monitor” section.
Added the “Electromagnetic Environment Specifications”
section.
Fixed paragraph misalignment where needed.

vi Infant Flow SiPAP
675–101–101 Rev. P
Warranty
Infant Flow™ SiPAP is warranted to be free from defects in material and workmanship
and to meet the published specifications for One (1) year from date of shipment.
The liability of CareFusion Corporation (referred to as the Company) under this
warranty is limited to replacing, repairing or issuing credit, at the discretion of the
Company, for parts that become defective or fail to meet published specifications
during the warranty period; the Company will not be liable under this warranty unless
(A) the Company is promptly notified in writing by Buyer upon discovery of defects or
failure to meet published specifications; (B) the defective unit or part is returned to
the Company, transportation charges prepaid by Buyer; (C) the defective unit or part
is received by the Company for adjustment no later than four weeks following the last
day of the warranty period; and (D) the Company’s examination of such unit or part
shall disclose, to its satisfaction, that such defects or failures have not been caused
by misuse, neglect, improper installation, unauthorized repair, alteration or accident.
Any authorization of the Company for repair or alteration by the Buyer must be in
writing to prevent voiding the warranty. In no event shall the Company be liable to
the Buyer for loss of profits, loss of use, consequential damage or damages of any
kind based upon a claim for breach of warranty, other than the purchase price of any
defective product covered hereunder.
The Company warranties as herein and above set forth shall not be enlarged,
diminished or affected by, and no obligation or liability shall arise or grow out of the
rendering of technical advice or service by the Company or its agents in connection
with the Buyer's order of the products furnished hereunder.
Limitation of Liabilities
This warranty does not cover normal maintenance such as cleaning, adjustment or
lubrication and updating of equipment parts. This warranty shall be void and shall not
apply if the equipment is used with accessories or parts not manufactured by the
Company or authorized for use in writing by the Company or if the equipment is not
maintained in accordance with the prescribed schedule of maintenance.
The warranty stated above shall extend for a period of One (1) year from date of
shipment, with the following exceptions:
1. Components for monitoring of physical variables such as temperature, pressure,
or flow are warranted for ninety (90) days from date of receipt.
2. Elastomeric components and other parts or components subject to deterioration,
over which the Company has no control, are warranted for sixty (60) days from
date of receipt.
3. Internal batteries are warranted for ninety (90) days from the date of receipt.
The foregoing is in lieu of any warranty, expressed or implied, including, without
limitation, any warranty of merchantability, except as to title, and can be amended
only in writing by a duly authorized representative of the Company.

Infant Flow SiPAP vii
675–101–101 Rev. P
Contents
Revision History .........................................................................................................iii
Warranty ....................................................................................................................vi
Contents ...................................................................................................................vii
List of Figures .......................................................................................................... viii
Notices.......................................................................................................................ix
Chapter 1 Product Description .................................................................................. 1
Chapter 2 Product Specifications.............................................................................. 3
Chapter 3 Summary of Warnings and Cautions........................................................ 7
Chapter 4 Unpacking and Setup............................................................................. 11
Chapter 5 Operation ............................................................................................... 23
Chapter 6 Operating Modes.................................................................................... 35
Chapter 7 Alarms and Indicators............................................................................. 37
Chapter 8 Maintenance and Cleaning..................................................................... 43
Chapter 9 Explanation of Symbols.......................................................................... 45
Appendix A Product Configurations ........................................................................ 49
Appendix B Pneumatic Diagram ............................................................................. 51
Appendix C Alarm Troubleshooting ........................................................................ 53
Appendix D Fault Management............................................................................... 57
Glossary................................................................................................................... 63
Index........................................................................................................................ 65

viii Infant Flow SiPAP
675–101–101 Rev. P
List of Figures
Figure 1 Stand unpacking and assembly..........................................................11
Figure 2 Stand and Driver assembly................................................................. 12
Figure 3 Driver assembled with patient circuit and /humidifier ..........................13
Figure 4 Attaching the Abdominal Respiratory Sensor .....................................14
Figure 5: Flow pressure nomogram for 675-CFG-XXX when used with the Infant
Flow variable-flow generator..............................................................................15
Figure 6: Flow pressure nomogram for 675-CFG-XXX when used with the Infant
Flow LP or AirLife variable-flow generator .........................................................16
Figure 7 Front Panel .........................................................................................23
Figure 8 Rear Panel.......................................................................................... 24
Figure 9 Setup Screen......................................................................................28
Figure 10 Alarm set/confirm Screen .................................................................29
Figure 11 Mode Select Screen ......................................................................... 29
Figure 15 NCPAP .............................................................................................35
Figure 16 BiPhasic............................................................................................35
Figure 17 BiPhasic tr.........................................................................................36
Figure 18 Flat Battery screen............................................................................ 39

Infant Flow SiPAP ix
675–101–101 Rev. P
Notices
EMC Notice
This equipment radiates and is susceptible to radio frequency energy. If not installed
and used in accordance with the instructions in this manual, electromagnetic
interference may result. The equipment has been tested and found to comply with
the limits set forth in BS EN60601-1-2 for Medical Electrical Equipment Part 1-2:
General requirements for safety-collateral standard, Electromagnetic compatibility –
requirements and tests. These limits provide reasonable protection against
electromagnetic interference when operated in the intended use environments (e.g.
hospitals) described in this manual.
This device is also designed and manufactured to comply with the following
standards:
Safety: UL 60601-1: 2003 Medical Electrical Equipment, Part 1: General
Requirements for Safety.
CAN/CSA C22.2 No 601.1-M90, Medical Electrical Equipment - Part 1:
General Requirements for Safety including C22.2 No. 601.1S1-94 (IEC601-
1, Amendment 1:1991) Supplement No. 1-94 to CAN/CSA 22.2 No. 601.1-
M90, EN ISO 21647
Electrical Safety:
Class 1 equipment
Contains type BF patient applied parts
Continuous Operation
MRI Notice
This equipment contains electromagnetic components whose operation can be
affected by intense electromagnetic fields.
Do not operate this device in a MRI environment or in the vicinity of high-frequency
surgical diathermy equipment, defibrillators, or short-wave therapy equipment.
Electromagnetic interference could disrupt the operation of the device.

xInfant Flow SiPAP
675–101–101 Rev. P
Electromagnetic Environment Specifications