Cardinal Health Infant Flow SiPAP User manual

675-101-101
Revision H
Operator’s Manual
Infant Flow®
SiPAP™
© Copyright 2009 Cardinal Health, Inc.

ii Infant Flow®SiPAP™
675-101-101
Revision H
Revision History
Date Revision Pages Changes
September 2003 675-101(3) All Release
August 2004 D All Release manual in VIASYS Respiratory
Care template using VIASYS Respiratory
Care nomenclature. Revise part number
list in Appendix B approved accessories.
November 2004 E All 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 8
10 Updated the contact information. Updated the Declaration of Conformity
Notice.
Throughout Updated the company name.
iii Updated the Contact and Ordering
Information.
11, 12, 23 Update the figures.
14 Added a Caution regarding back pressure.
Added a Note regarding the Hudson RCI
Humidification System.
17 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 O2
Sensor Calibration.
19 Changed step 8 regarding the nCPAP
pressure.
23 Changed the second and third paragraphs
under Changing a Control.
24 Added “Setting a Manual Breath.”
26 Added a note regarding the enabling of
manual breath or back-up apnea breath.
30 Added a warning concerning infant flow
consumables.
May 2006 G
39 Added the statement “Disconnect the air
and oxygen gas sources when the Infant

Operator’s Manual iii
675-101-101
Revision H
Flow SiPAP™is not in use.”
59 Removed Appendix E.
February 2009 H All Changed Ti to T-High and Inspiratory Time
to Time High.
All Replaced reference to VIASYS Respiratory
Care accessories with reference to
Cardinal Health accessories.
iv, viii, 9, 10, 16,
19, 43 Added “TM” superscript to “SiPAP”.
1, 21, 35
1, 35, 36, 51
Added reference to AirLifeTM Infant nCPAP
System Generator.
Removed “inspiratory time” or “inspiration
time”.
3 Replaced “Inspiratory Time (Time High)”
with “Time High (Thigh)”
4 Changed 1 cmH2O to 1.5 cmH2O; Added
“or 60 psi” to clarify 4 bar.
6
Added the parts list for both Infant Flow®
Products and AirLifeTM Products.
7 Added reference to Cardinal Health
contact information on page v.
8 Added reference to AirLifeTM Infant nCPAP
System accessories.
10
11
Added a warning about using an external
oxygen monitor.
Added reference to factory trained
technician and Service Manual P/N 675-
120.
11, 16, 19, 34, 43 Added “®” (registered symbol) superscript
to Infant Flow.
14 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.”
15 Replaced Figure 5.
17 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

iv Infant Flow®SiPAP™
675-101-101
Revision H
external oxygen monitor must be used.
28
28, 41, 48, 51
Added a Note regarding the 2nd Flow Meter
being used for manual breath delivery;
Added hyphen in “T-High”.
29 Clarified the “Mode Select Screen”
34 Added “Directions for using the AirLifeTM
Infant nCPAP System.
36
38 Changed 1 cmH2O to 1.5 cmH2O;
Corrected low battery voltage level from 10
to 11.10.
41 Added “or trained biomedical engineer”.
46 Added a table entry for the oxygen monitor
and alarms disable.
54 Changed 1 cmH2O to 1.5 cmH2O;
corrected low battery voltage level from 10
to 11.10.
58 Updated Table 10.
60 Updated Table 11.
63 Clarified the meaning of T-High.

Operator’s Manual v
675-101-101
Revision H
Contact and Ordering Information
USA
Cardinal Health
Respiratory Technologies
1100 Bird Center Drive
Palm Springs, California 92262-8099
Authorized European Representative
Cardinal Health Germany 234 GmbH
Leibnizstrasse 7
97204 Hoechberg
Germany
Telephone:
Fax:
800.231.2466
+1.714.283.2228
+1.714.283.8493
Telephone:
Fax:
+49.931.4972.0
+49.931.4972.423
cardinalhealth.com/viasys

vi Infant Flow®SiPAP™
675-101-101
Revision H
Warranty
Infant Flow® SiPAPTM 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 Cardinal Health (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.

Operator’s Manual vii
675-101-101
Revision H
Contents
Revision History....................................................................................ii
Contact and Ordering Information.......................................................v
Warranty................................................................................................vi
Contents...............................................................................................vii
List of Figures.....................................................................................viii
List of Tables ......................................................................................viii
Notices ..................................................................................................ix
Chapter 1 - Product Description ..........................................................1
Chapter 2 - Product Specifications......................................................3
Chapter 3 - Summary of Warnings and Cautions...............................7
Chapter 4 - Unpacking & Setup..........................................................11
Chapter 5 - Operation..........................................................................23
Chapter 6 - Operating Modes .............................................................33
Chapter 7 - Alarms and Indicators.....................................................35
Chapter 8 - Maintenance & Cleaning.................................................41
Chapter 9 – Explanation of Symbols.................................................43
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
Revision H
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 ........................................................................15
Figure 6 – Front Panel.................................................................................................23
Figure 7 – Rear Panel ..................................................................................................24
Figure 8 – Set Up Screen.............................................................................................27
Figure 9 – Alarm set/confirm Screen .........................................................................28
Figure 10 – Mode Select Screen.................................................................................29
Figure 11 – Parameter Adjust Screens......................................................................29
Figure 12 – Main Screen..............................................................................................30
Figure 13 – Monitored Parameters Screen................................................................30
Figure 14 – NCPAP ......................................................................................................33
Figure 15 – BiPhasic....................................................................................................33
Figure 16 – BiPhasic tr................................................................................................34
Figure 17 - Flat Battery screen ...................................................................................37
List of Tables
Table 1 – Functions and Accessories..........................................................................2
Table 2 - Soft-key operation........................................................................................25
Table 3 – Parameter Default Value.............................................................................27
Table 4 – Alarm Symbols and Indicators...................................................................38
Table 5 – Equipment Symbols....................................................................................43
Table 6 – Button Symbols...........................................................................................45
Table 7 – Non-US Configuration Parameters ............................................................49
Table 8 – US Configuration Parameters ....................................................................49
Table 9 – Alarm Troubleshooting...............................................................................53
Table 10 – Fault Classification....................................................................................57
Table 11 – Fault Recovery...........................................................................................58

Operator’s Manual ix
675-101-101
Revision H
Notices
Copyright Notice
© Copyright 2009 Cardinal Health, Inc.
This work is protected under Title 17 of the U.S. Code and is the sole property of the
Company. No part of this document may be copied or otherwise reproduced, or
stored in any electronic information retrieval system, except as specifically permitted
under U.S. Copyright law, without the prior written consent of the Company.
For more information, contact:
USA
Cardinal Health
Respiratory Technologies
1100 Bird Center Drive
Palm Springs, California 92262-8099
Authorized European Representative
Cardinal Health Germany 234 GmbH
Leibnizstrasse 7
97204 Hoechberg
Germany
Telephone:
Fax:
800.231.2466
+1.714.283.2228
+1.714.283.8493
Telephone:
Fax:
+49.931.4972.0
+49.931.4972.423
cardinalhealth.com/viasys
Trademark Notice
Infant Flow® and SiPAP™ are trademarks of the Cardinal Health group of companies
in the United States and some other countries. All other brand names and product
names mentioned in this manual are trademarks, registered trademarks, or trade
names of their respective holders.

xInfant Flow®SiPAP™
675-101-101
Revision H
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
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.
Intended Use Notice
The Infant Flow® SiPAP™, consisting of a Driver and Generator plus NCPAP Prongs
and Masks, is intended for the provision of Bi-Level CPAP (SiPAP™) to produce a sigh.
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™ should only be operated by properly trained clinical
personnel, under the direction of a physician.