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 logo, and Infant Flow are trademarks of CareFusion Corporation or one of its subsidiaries.
All other trademarks are the property of their respective owners.
CareFusion
22745 Savi Ranch Parkway
Yorba
Linda, CA 92887
U.S.A.
CareFusion Germany 234 GmbH
Leibnizstrasse
7
97204 H
oechberg
Germany
800.231.2466 toll-free
714
.283.2228 tel
714.283.
8493 fax
+49 931 4972.0 tel
[phone].
423 fax
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

Infant Flow SiPAP xi
675–101–101 Rev. P

xii 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.

Infant Flow SiPAP xiii
675–101–101 Rev. P
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:
EN60601-1 and EN60601-1-2
EN 10993
EN 14971
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
Infant Flow
SiPAP
Manufactured by:
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, CA 92887-4668
If you have a question regarding the Declaration of Conformity for this product,
please contact CareFusion.

xiv Infant Flow SiPAP
675–101–101 Rev. P
Infant Flow SiPAP

Infant Flow SiPAP 1
675–101–101 Rev. P
Chapter 1 Product Description
Infant Flow™ SiPAP driver provides a non-invasive form of respiratory support
designed for infants in hospital environments such as Neonatal and Pediatric
Intensive Care Units. It can also be used when transporting these patients within the
hospital environment.
Infant Flow SiPAP driver is currently available in a Plus or Comprehensive*
configuration. The Plus configuration provides NCPAP and time triggered BiPhasic
modes with and without breath rate monitoring. The Comprehensive* configuration
offers these features plus a patient triggered BiPhasic mode with apnea backup
breaths. The Infant Flow SiPAP driver comes standard in all configurations with an
LCD touch screen display, pressure time waveform graphics, integrated patient
monitoring, alarms for high and low pressure and FiO2and up to 2 hours of backup
battery power.
As a result of the unique, patented design, the Infant Flow, Infant Flow LP or AirLife
Infant nCPAP System Generators have been proven to provide the most stable
CPAP at the lowest work of breathing for patients compared to other devices (1). The
outstanding performance of variable flow generators is irrespective of patient
demand or expiratory flows. The SiPAP driver has been designed and tested to
perform optimally when used only with accessories available from CareFusion.
These accessories include the variable flow generator, single limb breathing circuit,
nasal prongs, nasal masks, and fixation device, either bonnet or headgear.
Infant Flow SiPAP Features
The expanded capabilities of the Infant Flow SiPAP Plus and Comprehensive*
configurations allow for applications to broader range of patients who may otherwise
not be candidates for non-invasive respiratory support from NCPAP alone (2,3).
NCPAP – continuous positive airway pressure based on clinician set pressure.
Breath rate monitoring/alarm can be activated in this mode.
BiPhasic – time triggered pressure assists are delivered based on clinician set
Time-High, rate and pressure criteria. Breath rate monitoring/alarm can be activated
in this mode.
BiPhasic tr*– patient triggered pressure assists delivered based on clinician set
Time-High and pressure criteria. Breath rate monitoring/alarm and Apnea backup
breaths are automatically active in this mode.
Infant Flow, Infant Flow LP, or AirLife Infant nCPAP System Generator – The
Infant Flow Generator is a fluidic device for the generation of consistent infant nasal
CPAP with a low work of breathing compared to other devices(1).
Fully integrated alarm package – Supply gases failure, High Patient Pressure, Low
patient pressure, high and low delivered Oxygen concentration, change from AC to
DC power source, low and flat battery charge status and Low breath rate/apnea
alarm.

2Chapter 1 Product Description
675–101–101 Rev. P
Battery Backup – Up to 2 hours of battery backup allows for intra-hospital transport.
Clear indicators are provided for power supply in use (AC or DC), and battery charge
level.
Screen Lock – After 120 seconds of no screen inputs, the screen changes to the
Locked Screen to prevent inadvertent changes. Upon activation of a high priority
alarm the screen changes to an unlocked state to allow access to controls.
Table 1 Functions and Accessories
Functions and Accessories Plus Comprehensive*
NCPAP
•
•
NCPAP with breath rate monitoring
and alarm
•
•
BiPhasic
•
•
BiPhasic with breath rate monitoring
and alarm
•
•
BiPhasic tr*
•
Internal Battery
•
•
Manual Breath
•
•
Apnea Back up rate
•
Screen lock
•
•
Prioritization of alarms
•
•
*Comprehensive configuration not available for sale in the United States
(1) Decreased imposed work with a new nasal continuous positive airway pressure
device. Klausner, James F., PhD, Lee, Amy., Hutchison, Alastair A., FRACP.
Pediatric Pulmonology 22: 188-194; 1996
(2) A Prospective Randomized, Controlled Trial Comparing Synchronized Nasal
Intermittent Positive Pressure Ventilation versus Nasal Continuous Positive
Airway Pressure as Modes of Extubation. Khalaf Nabeel, M., Brodsky Nancy,
Hurley John, Bhandari Vineet. PEDIATRICS 108 (1): 13-17: 2001
(3) Efficacy of Nasal Intermittent Positive Pressure Ventilation in Treating Apnea of
Prematurity. Lin Chyi-Her, MD, Wang Shan-Tair, PhD, Lin Yuh-Jyh, MD, Yeh
Tsu-Fuh, MD: Pediatric Pulmonology: 26 (5): 349-53; 1996

Infant Flow SiPAP 3
675–101–101 Rev. P
Chapter 2 Product Specifications
Modes
•NCPAP
•NCPAP with breath rate monitoring and low rate alarm
•BiPhasic (time triggered)
•BiPhasic (time triggered) with breath rate monitoring and low rate alarm
•BiPhasic tr (patient triggered) with breath rate monitoring, low breath rate alarm
and apnea back up (Comprehensive models only)
Controls
•Time High (T-High) – 0.1 – 3.0 seconds
•Rate (R)
•1-120 (Non-U.S. Configuration Parameters)
•1-54 (U.S. Configuration Parameters)
•Apnea Interval
•(Tapnea) – 10-30 seconds, 5 second intervals (Non-U.S. Configuration
Parameters)
•(TLBR) – 10-30 seconds; 5 second intervals (U.S. Configuration Parameters)
•NCPAP / Pres Low flow meter – 0-15 L/min, accuracy ±15% of selected output
•Pres High flow meter – 0-5 L/min, accuracy ±15% of selected output
•Manual Breath – X 1
•%O2– 21 -100%
Monitors
•CPAP
•PEEP
•MAP
•PIP
•%O2
•I:E ratio
•Spontaneous rate (Rsp)
•Battery charge level

4Chapter 2 Product Specifications
675–101–101 Rev. P
Alarms
•High airway pressure – 3 cmH2O above measured airway pressure
•Airway over-pressure limit alarm
•maximum 11 cmH2O in NCPAP and time triggered BiPhasic mode
•maximum 15 cmH2O in patient triggered BiPhasic tr mode
•Low airway pressure – 2 cmH2O below measured airway pressure or
1.5 cmH2O if otherwise would be zero
•High and Low delivered Oxygen concentration ±5% of setting. Minimum and
maximum delivered FiO2 is 18 and 104% respectively.
•Low breath rate alarm
•Low battery charge level
•Flat battery
•Input gases failure
•Alarm volume (electronic alarms) 70 dBa at 1 meter
Pneumatic Supply
•Patient Gas Outlet: 15 mm standard taper fitting
•Patient Pressure Input: 4.5 mm Luer taper fitting
•Gas Supply: Nominal 4 bar or 60 psi, clean, dry medical air and oxygen
•Range: 4.8 to 6 bar (40.6 to 87 PSI); Maximum differential pressure 2 bar,
(30 psi)
•Manometer: Range 0 to + 20 cmH2O, accuracy, ±2% of span
•Gas Connections: Standard DISS, NIST or Air Liquide connectors
Electrical Supply
•Input Voltage: 100-230 VAC
•Input Frequency: 50/60 Hz
•Power Consumption: 50 VA maximum
•Fuse Rating For 220 V nominal operation: “T” Type 2.5 A at 250 V
•Device Housing Protection rating level: IPX1
•Battery Working Time: 2 hours (from fully charged state)
•Battery Charging Time: max. 16 hours

Chapter 2 Product Specifications 5
675–101–101 Rev. P
Atmospheric and Environmental
•Temperature Range
•Operating: 5 to 40° C
•Storage: - 20 to 60° C
•Relative Humidity -Operating: 0 to 95% non-condensing
•Storage: 0 to 95% non-condensing
Physical
•Dimensions (Driver only)
•(W x H x D) 26 x38 x 23.5 cm
•(W x H x D) 10.25 x15 x 9.25 in
•Weight (Driver only)
•8.8 kg
•19.5 lb
Accessories
•Silencer / Bacterial Filter - The additional resistance of the D1420/100 Silencer /
Bacterial Filter and adaptor is less than 0.56 cmH2O at 15 LPM, and less than
0.40 cmH2O at 5 LPM.
SiPAP Gas Monitor
•Total system response time: 8.61 seconds
•Drift: No drift after six hours of operation
•Cyclical pressure: Up to 10 Kpa (100 cmH2O)—has no effect on the gas monitor
accuracy
•Accuracy of the oxygen reading at 30, 40 and 60%: No drift when cycling the
ventilator
•With non-diverting flow at 10 mL/min at a pressure of 60 Kpa (60 cmH2O), the
ventilator and sensor show no leaks.
•The gas monitor uses the internal battery and is not affected by power
interruptions or fluctuations of the external power.

6Chapter 2 Product Specifications
675–101–101 Rev. P
Infant Flow SiPAP