CareFusion Infant Flow SiPAP User manual
Infant Flow® SiPAP™
Operator’s manual
ii Infant Flow
®
SiPAP™
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This document may not be copied, reproduced, translated, stored in a retrieval system,
transmitted in any form, or reduced to any electronic medium or machine-readable form,
in whole or in part, without the written permission of CareFusion. Information in this
document is subject to change without notice.
This document is for informational purposes only and should not be considered as
replacing or supplementing the terms and conditions of the License Agreement.
© 2009–2010 CareFusion Corporation or one of its subsidiaries. All rights reserved. Infant
Flow is a registered trademark and SiPAP is a trademark of CareFusion Corporation or one
of its subsidiaries. All other trademarks are the property of their respective owners.
USA
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, California 92887-4668
Authorized European Representative
CareFusion Germany 234 GmbH
Leibnizstrasse 7
97204 Hoechberg, Germany
District Court Wuerzburg HRB7004
800.231.2466 tel
+1.714.283.2228 tel
+49.931.4972.0 tel
+49.931.4972.423 fax
+1.714.283.8493 fax
carefusion.com
Literature number: 675–101–101 Revision K
675–101–101 Rev. K
Infant Flow® SiPAP™ iii
R evision 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
March 2005 F Updated the contact information.
May 2006 G Updated the company name.
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.
Updated the Declaration of Conformity Notice.
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”
under “Two Point O
Changed step 8 regarding the nCPAP pressure.
Changed the second and third paragraphs under Changing a
Control.
Sensor Calibration.
2
to the first paragraph
Added “Setting a Manual Breath.”
Added a note regarding the enabling of manual breath or backup apnea breath.
Added a warning concerning infant flow consumables.
Added the statement “Disconnect the air and oxygen gas
sources when the Infant Flow SiPAP
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
675–101–101 Rev. K
™ is not in use.”
iv Infant Flow
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 AirLifeTM 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.”
®
SiPAP™
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 2nd Flow Meter being used for
manual breath delivery;
Added hyphen in “T-High”.
Clarified the “Mode Select Screen”
Added “Directions for using the AirLifeTM 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.
675–101–101 Rev. K
Infant Flow® SiPAP™ v
Date Revision Changes
March 2010 K Rebranded the manual to the CareFusion style.
Updated the part number table.
675–101–101 Rev. K
vi Infant Flow
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 CareFusion (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.
®
SiPAP™
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.
675–101–101 Rev. K
Infant Flow® SiPAP™ vii
Contents
Revision History ......................................................................................................... iii
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
675–101–101 Rev. K
viii Infant Flow
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
®
SiPAP™
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
675–101–101 Rev. K
Infant Flow® SiPAP™ ix
Notices
E MC Notic e
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
MR I 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
personnel, under the direction of a physician.
®
SiPAP™ should only be operated by properly trained clinical
675–101–101 Rev. K
x Infant Flow
R egulatory 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.
Clas sification
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.
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
®
SiPAP™
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
®
Infant Flow
SiPAP™
Manufactured by:
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, California 92887-4668
If you have a question regarding the Declaration of Conformity for this product,
please contact CareFusion.
675–101–101 Rev. K
Infant Flow® SiPAP™ 1
Chapter 1 - Product Description
Infant Flow® SiPAP™ 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
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
LCD touch screen display, pressure time waveform graphics, integrated patient
monitoring, alarms for high and low pressure and FiO
battery power.
As a result of the unique, patented design, the Infant Flow
System Generator has been proven to provide the most stable CPAP at the lowest
work of breathing for patients compared to other devices
performance of the Infant Flow
expiratory flows. This system has been designed and tested to perform optimally
when used only with accessories available from CareFusion. These accessories
include circuits and generators, prong and mask patient interfaces and bonnets.
®
SiPAP™ is currently available in a Plus or Comprehensive*
®
SiPAP™ comes standard in all configurations with an
and up to 2 hours of backup
2
®
or AirLifeTM Infant nCPAP
(1)
®
Generator is irrespective of patient demand or
. The outstanding
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
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.
Patented Infant Flow
®
Flow
Generator is a fluidic device for the generation of consistent infant nasal CPAP
with a low work of breathing compared to other devices
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.
®
or AirLifeTM Infant nCPAP System Generator - The Infant
(2,3)
.
(1)
.
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.
675–101–101 Rev. K
2 Chapter 1 - Product Description
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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 & 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 Pulmonolgy:
26 (5): 349-53; 1996
675–101–101 Rev. K
Infant Flow® SiPAP™ 3
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
• (T
• (TLBR) – 10-30 seconds; 5 second intervals (U.S. Configuration
• 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
• %O
Monitors
• CPAP
• PEEP
• MAP
• PIP
) – 10-30 seconds, 5 second intervals (Non-U.S. Configuration
apnea
Parameters)
Parameters)
– 21 -100%
2
• %O
• I:E ratio
• Spontaneous rate (Rsp)
• Battery charge level
675–101–101 Rev. K
2
4 Chapter 2 - Product Specifications
Alarms
• High airway pressure – 3 cmH2O above measured airway pressure
• Airway over-pressure limit alarm
• maximum 11 cmH
• maximum 15 cmH2O in patient triggered BiPhasic tr mode
• Low airway pressure – 2 cmH
1.5 cmH
O if otherwise would be zero
2
• 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
O in NCPAP and time triggered BiPhasic mode
2
O below measured airway pressure or
2
• Range: 40.61 to 87 PSI; Maximum differential pressure 29 PSI
• Manometer: Range 0 to + 20 cmH
• 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
O, accuracy, ± 2% of span
2
675–101–101 Rev. K
Infant Flow® SiPAP™ 5
Atmospheric & Environmental
• Temperature Range
Operating: 5 – 40° C
Storage: - 20 - 50° C
• Relative Humidity -Operating: 0 – 95% non-condensing
• Storage: 0 – 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 cmH
and less than 0.40 cmH
O at 5 LPM.
2
O at 15 LPM,
2
675–101–101 Rev. K
6 Chapter 2 - Product Specifications
F&P 730
773386–102
Patient Circuit w/Generator (box of 20)
773387–101
Patient Circuit (box of 20)
773388–105
Patient Circuit RCI 16V (box of 20)
Prongs
Masks
777086–101
Nasal Mask - Small (box of 10)
006905
NCPAP Generator Kit
006915
Nasal Prongs - Medium
006920
Nasal Prongs - Large
Part No. Description
Infant Flow® Products
D1420/100 Silencer (box of 20)
11541–101 Patient Circuit Assembly (box of 20)
11541–102 Patient Circuit Assembly w/Generator (box of 20)
773386–101 Patient Circuit (box of 20)
F&P 850
12204–101 Patient Circuit (box of 20)
12204–102 Patient Circuit w/Generator (box of 20)
12233–102 Patient AirLife Circuit w/Generator (box of 20)
12233–101 Patient AirLife Circuit (box of 20)
RCI
773388–103 Patient Circuit w/Generator RCI 16V (box of 20)
773389–105 Patient Circuit RCI 21V (box of 20)
773389–104 Patient Circuit w/Generator RCI 21V (box of 20)
11513–101 Nasal Prongs - Small (box of 10)
11513–102 Nasal Prongs - Medium (box of 10)
11513–103 Nasal Prongs - Large (box of 10)
777086–102 Nasal Mask - Medium (box of 10)
777086–103 Nasal Mask - Large (box of 10)
777086–104
Nasal Mask Extra Large (box of 10)
AirLifeTM Products (U.S.A. only)
Prongs
006910 Nasal Prongs - Small
Masks
006925 Nasal Mask - Small
006930 Nasal Mask - Medium
006935 Nasal Mask - Large
675–101–101 Rev. K
Infant Flow® SiPAP™ 7
Chapter 3 - Summary of Warnings and Cautions
Please review the following safety information prior to operating the Infant Flow
SiPAP™. Attempting to operate this equipment without fully understanding its
features and functions may result in unsafe operating conditions.
Warnings and Cautions, which are general to the use of the device under all
circumstances, are included in this section. Some Warnings and Cautions are also
inserted within the manual where they are most meaningful.
Notes are also located throughout the manual to provide additional information
related to specific features.
If you have a question regarding the installation, set up, operation, or maintenance of
the device, contact CareFusion (see page v).
Terms
WARNINGS identify conditions or practices that could result in serious adverse
CAUTIONS identify conditions or practices that could result in damage to the
NOTES identify supplemental information to help you better understand how
®
reactions or potential safety hazards.
driver or other equipment.
the driver works.
Warnings
• Infant Flow® SiPAP™ is intended for use by a trained practitioner, under the
direct supervision of a qualified physician.
• When the Infant Flow
care professional should be in attendance at all times to react to an alarm or
other indications of a problem.
• Always have an alternate means of ventilation available whenever the Infant
Flow
• Do not attach the Generator to the patient until User Verification and initial set
up into NCPAP mode is complete.
• Water in the air supply can cause malfunction of this equipment.
• The operator should not touch the electrical connectors of the Infant Flow®
SIPAP™ or its accessories, and the patient simultaneously.
• An audible alarm indicates an anomalous condition and should never go
unheeded.
®
®
SiPAP™ is in use.
SiPAP™ is connected to a patient, a trained health
675–101–101 Rev. K
8 Chapter 3 - Summary of Warnings and Cautions
• Anti-static or electrically conductive hoses or tubing should not be used within
the patient circuit.
• If a mechanical or electrical problem is recognized while operating the Infant
®
Flow
SiPAP™, it must be removed from use and referred to qualified service
personnel for servicing. Using inoperative equipment may result in patient
injury.
• Prior to patient application, ensure that all User Verification testing and
calibration procedures are successfully completed. User Verification testing
and calibration procedures must be done off patient.
• The
indicates a connection between the Transducer Assembly and the
driver. It does not indicate attachment or correct positioning of the Abdominal
Respiratory Sensor.
• Under certain conditions (minimum supply pressure and maximum gas
demand, including auxiliary output) output flow rates and therefore pressure
delivered to the generator may be reduced.
• The Pres High
flow meter must be adjusted to zero when not required for the
patient.
• Whenever a patient is attached to respiratory care equipment, constant
attendance is required by qualified personnel. The use of an alarm or
monitoring system does not give absolute assurance of warning for every
malfunction that may occur in the system. In addition, some alarm conditions
may require immediate attention.
• Nasal CPAP treatment in general can cause nasal irritation, septal distortion,
skin irritation and pressure necrosis. Adherence to the recommended usage
instructions for the Infant Flow
®
SiPAP™ and AirLifeTM Infant nCPAP System
accessories may reduce the incidence of these complications.
• It is strongly recommended that regular monitoring for gastric distention be
carried out for patients receiving non-invasive ventilatory support. Refer to
your facility’s policy and procedure for further guidance.
• This device exhausts O
during normal operation. Oxygen vigorously
2
accelerates combustion. To avoid fire hazard, do not place flammable
materials or sources of heat close to the exhaust.
• The Abdominal Respiratory Sensor is used only to enable features
associated with certain modes from the Infant Flow
®
SiPAP™. When using
the Abdominal Respiratory Sensor, always use an additional, external device
for monitoring of the respiratory rate and detection of apneic episodes as well
as an appropriate monitor for continuous SaO
®
• If the Infant Flow
SiPAP™ driver is shelf mounted, ensure that the driver is
monitoring.
2
stable and that all circuit tubing, hoses and cables are restrained to avoid
hazard of toppling.
• Check that the water trap is empty before use and empty it frequently during
use.
• Do not block or restrict the exhaust port located on the instrument back panel.
Equipment malfunction may result.
675–101–101 Rev. K
Infant Flow® SiPAP™ 9
• Do not use the equipment without the expiratory tubing connected to the
generator.
• Only use the supplied AC cable to connect to the power supply.
• The Transducer LED indicator on the front panel of the driver only signifies
connection to the driver. It does not indicate connection to or proper
positioning of the Abdominal Respiratory Sensor.
• Do not overload the pole and stand.
• Oxygen vigorously accelerates combustion. To avoid explosion hazard, do
not use any instrument or other equipment that may have been exposed to oil
or grease contamination.
• When a low gas supply alarm occurs, the oxygen concentration delivered to
the patient will differ from that set on the %O
control.
2
• A source gas failure will change the FiO2 and may result in patient injury.
• The functioning of this equipment may be adversely affected by the operation
of other equipment nearby, such as high frequency surgical (diathermy)
equipment, defibrillators, short-wave therapy equipment, “walkie-talkies”, or
cellular phones.
• Due to possible explosion hazard, the Infant Flow
®
SiPAP™ should not be
used in the presence of flammable anesthetics.
• Electric shock hazard – Do not remove any of the Infant Flow
®
SiPAP™
covers or panels. Refer all servicing to an authorized CareFusion service
technician or factory trained technician (see Service Manual P/N 675-120).
• A protective ground connection by way of the grounding conductor in the
power cord is essential for safe operation. Upon loss of protective earth
ground, all conductive parts including knobs and controls that may appear to
be insulated can render an electrical shock. To avoid electrical shock, plug
the power cord into a properly wired receptacle, use only the power cord
supplied with the ventilator, and make sure the power cord is in good
condition.
• The Infant Flow
®
SiPAP™ is designed to ensure that the user and patient are
not exposed to excessive leakage current per applicable standards.
However, this cannot be guaranteed when external devices are attached to
the driver. In order to prevent the risk of excessive enclosure leakage current
from external equipment attached to the driver, isolation of the protective
earth paths must be provided to ensure proper connection. This isolation
should ensure that the cable shields are isolated at the peripheral end of the
cable.
• When the Infant Flow
internal oxygen monitor is disabled, the Infant Flow
®
SiPAPTM unit is connected to a patient, and the
®
SiPAPTM unit must be
used with an external oxygen monitor.
675–101–101 Rev. K
10 Chapter 3 - Summary of Warnings and Cautions
Cautions
• Before use, verify that this equipment has been authorized for use by
qualified technical service personnel.
• Ensure that the voltage and installed fuses are set to match the voltage of the
wall outlet, or damage may result.
• A battery that is fully drained (i.e. void of any charge) may cause damage to
the driver and should be replaced.
• All accessory equipment that is connected to the driver should comply with
CSA/IEC601/ETL.
• Although failure of any of the above tests will not prevent the ventilator from
functioning, it should be checked to make sure it is operating correctly before
use on a patient.
• The Infant Flow
CareFusion accessories. Only accessories approved for use by CareFusion
should be used. If in doubt, please contact your local sales representative.
®
SiPAP™ has been designed and tested using only
Notes
• Employ safe lifting procedures when assembling the unit.
• Do not sterilize the driver. The internal components are not compatible with
sterilization techniques.
• Do not submerge the driver or pour cleaning liquids over or into the driver.
• Following each alarm verification test, ensure that control settings and alarm
limits are reset as instructed before proceeding to the next test.
• CareFusion cannot ensure product performance as stated in this manual with
the use of Non-CareFusion accessories.
675–101–101 Rev. K
Infant Flow® SiPAP™ 11
Chapter 4 - Unpacking & Setup
Assembly and physical setup
Optional
Accessory
Figure 1 – Stand unpacking and assembly
675–101–101 Rev. K
12 Chapter 4 - Unpacking & Setup
Infant Flow
SiPAP Driver
Optional
Accessory
Figure 2 – Stand and Driver assembly
675–101–101 Rev. K
Infant Flow® SiPAP™ 13
Attaching a patient circuit
Infant Flow
SiPAP Driver
Optional
Accessory
Figure 3 – Driver assembled with patient circuit and /humidifier
Note
We recommend between 96.8 °F (36 °C) and 98.6 °F (37 °C) but never higher than
98.6 °F (37 °C) for inspired gases.
675–101–101 Rev. K
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