Care Fusion Infant Flow LP SiPAP User manual

Infant Flow®LP SiPAP and SiPAP Model M675
Service manual

ii Infant Flow®LP SiPAP Model M675
675–120 Rev. G
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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.
© 2008 – 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved Infant Flow is a
registered trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are
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
800.231.2466 tel
+1.714.283.2228 tel
+1.714.283.8493 fax
+49.931.4972.0 tel
+49.931.4972.423 fax
carefusion.com
Literature number: 675–120 Revision G

Service Manual iii
675-120 Rev. G
Revision History
Date Revision Changes
September 2003
675-120(1)
Release
November 2004 B Release manual in VIASYS Healthcare template using
VIASYS Healthcare Respiratory Care nomenclature.
December 2004 C Revised per EO 27980. Removed the picture
from the title page.
Deleted the ESD warning from page 19.
Removed “O2 Sensor” and added the word “measured”
on page 30.
Changed “O2 sensor” to “fuel cell” on pages 39, 45, 62,
68, 69, 73, 86, and 87.
Replaced the O2 senor row on page 50.
Updated the error codes on pages 56 and 57.
Replaced the warning on page 61.
Changed the Fitting procedure on pages
64, 68, and 75.
Changed step 6 on page 65.
Added Addendum A – Oxygen Leak Test
Changed Transducer Assy. To Transducer Interface on
page 88.
May 2005 D Revised per ECO 60329
Update address/contact info
Update battery remove/install procedure
Added note for fuel cell disposal
Update check valve assembly remove/install procedure
Update water trap & restrictor remove/install procedure
Delete redundant leak test
Update list of service parts
August 2008 E Updated company information
Updated company information
Corrected Table 2 and updated Table 3
Updated Figure 6
Updated Figure 10
Updated the section “Diagnostics.”
Updated Table 6 starting on page 43

iv Infant Flow®LP SiPAP Model M675
675-120 Rev. G
Date Revision Changes
April 2010 F Changed Ti to T-High throughout
Figure 5 - Diagnostic screen updated
Spelling correction from “GRD” to “GND”
Added “Note: transducer must be attached.”
Changed “10 V” to “11.10 V”
Updated Table 6 - Error Codes (E50 - E54) and added
E55
Removed “Blender (Check Valves and Filter) Annually”
from table 7.
Added “, and two screws on the case-bottom”.
Added “and document L2879”
Replaced Ti symbol with T-High symbol
Changed “PL5” to “PL2”
Replaced Figure 3
Replaced Figure 4 and 5. Changed “value doesn’t” to
“value on the external oxygen analyzer doesn’t”.
Changed “467352” to “68289”; changed “777245” to
“52700A”; removed items 677-005A, 675-311, S117635,
467461, 467460.
Removed item S117641; changed “675-310” to “M675A-
FRONT”
May 2011 G Added instructions and specifications for LP SiPAP
Model M675

Service Manual v
675-120 Rev. G
Warranty
The Infant Flow® LP SiPAP and SiPAP systems are 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.
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.

vi Infant Flow®LP SiPAP Model M675
675-120 Rev. G
Contents
Revision History................................................................................iii
Warranty ............................................................................................v
Limitation of Liabilities........................................................................v
Notices............................................................................................viii
EMC Notice ...............................................................................................................viii
MRI Notice.................................................................................................................viii
Intended Use Notice ...................................................................................................ix
Regulatory Notice .......................................................................................................ix
Classification ..............................................................................................................ix
Declaration of Conformity Notice .................................................................................x
Chapter 1 – Product Description................................................................................1
Chapter 2 – Product Specifications............................................................................3
Modes..........................................................................................................................3
Controls.......................................................................................................................3
Monitors.......................................................................................................................3
Alarms.........................................................................................................................4
Pneumatic Supply........................................................................................................4
Electrical Supply..........................................................................................................4
Atmospheric & Environmental......................................................................................5
Physical.......................................................................................................................5
Chapter 3 – Warnings and Cautions..........................................................................7
Terms..........................................................................................................................7
Warnings .....................................................................................................................7
Cautions ......................................................................................................................9
Chapter 4 – System Construction ............................................................................11
Touch Screen ............................................................................................................15
Alarm Conditions .......................................................................................................17
Diagnostic Screen......................................................................................................17
Chapter 5 – Theory of Operation..............................................................................19
Gas Flow ...................................................................................................................19
Electronic Functions ..................................................................................................22
Electrical Layout ........................................................................................................23
Fault Management.....................................................................................................24

Service Manual vii
675-120 Rev. G
Chapter 6 – Operational Setup................................................................................25
Preparing and Connecting the Equipment .......................................25
Switching On the IFSD ....................................................................29
User Verification Test ......................................................................30
Power-on Check ........................................................................................................30
Two Point O2Sensor Calibration................................................................................31
Leak Test...................................................................................................................32
Alarms Test................................................................................................................33
Infant Flow®LP SiPAP/SiPAP User Verification Test Checklist..................................35
Setting up the Equipment...........................................................................................36
Setting the NCPAP Parameters .................................................................................37
Setting the BiPhasic Parameters................................................................................38
Setting the Triggered BiPhasic Parameters................................................................39
Calibration..................................................................................................................41
Giving a Manual Timed Sigh......................................................................................41
Operation Without Electrical Power............................................................................41
Fault Indications.........................................................................................................42
Diagnostics................................................................................................................48
Chapter 7 – Maintenance......................................................................................... 55
Maintenance Frequencies................................................................55
PM Procedure............................................................................................................55
Tools Required...........................................................................................................55
Cleaning ..........................................................................................56
General......................................................................................................................56
Removal and Fitting of Case......................................................................................59
Removal and Fitting of Battery...................................................................................60
Removal and Fitting of Oxygen Filter.........................................................................61
Removal and Fitting of Fuel Cell Filter/Restrictor .......................................................62
Removal and Fitting of the Oxygen Sensor................................................................63
Removal and Fitting of Blender and Components......................................................64
Removal and Fitting of Water Trap Filter....................................................................68
Removal of the Pilot Drive Check Valves...................................................................68
Removal and Fitting of Case Bleed Filtered Restrictor...............................................69
Removal and Fitting of Valve/Sensor PCB.................................................................70
Removal and Fitting of the Muffler/Filter.....................................................................70
Chapter 8 – Explanation of Symbols........................................................................ 71
Appendix A – Oxygen Leak Test..............................................................................75
Appendix B – Product Configurations...................................................................... 79
Non-US Configuration Parameters.............................................................................79
US Configuration Parameters ....................................................................................79
Appendix C – Spare Parts .......................................................................................81
Appendix D – Pneumatics Assembly.......................................................................83
Glossary................................................................................................................... 85

viii Infant Flow®LP SiPAP Model M675
675-120 Rev. G
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
With regards to 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.

Service Manual ix
675-120 Rev. G
Intended Use Notice
The Infant Flow® LP SiPAP system, consisting of a Driver and Generator plus
NCPAP Prongs and Masks, is a medical device intended for the provision of Bi-Level
CPAP to produce a sigh. This system is for use in Hospital, Hospital Type facilities
and intra-Hospital transport environments and is indicated for the treatment of
Newborn and Infant patients.
Operators of this equipment and Service Engineers are required to read and thoroughly
understand the contents of this manual before using or maintaining the equipment.
This manual is intended for use by a competent, fully qualified Service
Engineer. It includes a description of the unit and how it works. It also contains
operating and diagnostic procedures and maintenance instructions. For usage
of associated equipment, refer to the Manufacturer’s literature.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
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.

xInfant Flow®LP SiPAP Model M675
675-120 Rev. G
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:
Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4)
Safety:EN 60601-1, EN 794-1
EMC: EN 60601-1-2:2001
Conformity Assessment: MDD Annex II
Quality System: ISO 13485
EU Notified Body: BSI (Reg. No. 0086)
Device Classification: IIb
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
Infant Flow LP SiPAP
Manufactured by:
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, CA 92887, USA
If you have a question regarding the Declaration of Conformity for this product,
please contact CareFusion.

Service Manual 1
675-120 Rev. G
Chapter 1 – Product Description
The Infant Flow® LP SiPAP and SiPAP systems are non-invasive forms of respiratory
support designed for use in hospital environments such as Neonatal and Pediatric
Intensive Care Units. They can also be used when transporting patients within the
hospital environment.
The Infant Flow® LP SiPAP and SiPAP systems are currently available in the 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 patient BiPhasic mode with
apnea backup breaths. The Infant Flow® LP SiPAP and SiPAP systems come
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® LP SiPAP and SiPAP
systems have been proven to provide the most stable CPAP at the lowest work-of-
breathing for patients compared to other devices. The outstanding performance of
the Infant Flow® LP SiPAP and SiPAP systems is irrespective of patient demand or
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.
Infant Flow® LP SiPAP and SiPAP Features
The expanded capabilities of the Infant Flow® LP SiPAP and SiPAP, Plus and
Comprehensive configurations, allow for applications to a broader range of patients
who may otherwise not be candidates for non-invasive respiratory support.
NCPAP. Allows for continuous positive airway pressure based on clinician set
pressure. Breath rate monitoring/alarm can be activated in this mode.
BiPhasic. Allows for time triggered pressure assists to be delivered based on
clinician set inspiratory time, rate, and pressure criteria. Breath rate monitoring/alarm
can be activated in this mode.
BiPhasic tr*. Allows for patient triggered pressure assists to be delivered based on
clinician set inspiratory time and pressure criteria. Breath rate monitoring/alarm, and
Apnea backup breaths are automatically active in the mode.
Patented Infant Flow® LP Generator. The Infant Flow® LP Generator is a fluidic
device for the generation of consistent infant nasal CPAP with a low work of
breathing. The Infant Flow LP system has a lower driving pressure than other
variable-flow devices.
Fully integrated alarms packages. 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.
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.

2Infant Flow®LP SiPAP Model M675
675-120 Rev. G
LP. Refers to the low driving pressure of the Infant Flow LP Generator. The Infant
Flow LP SiPAP system is compatible only with the Infant Flow LP Generator. The
prescribed nCPAP level will not be obtained if other variable flow generators are
used.
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 for immediate interventions
as required.
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
CAUTION!
The Infant Flow®LP SiPAP and SiPAP systems have been designed and tested
as complete systems using Infant Flow®accessories. Only accessories approved
for use should be used. If in doubt, please contact your local CareFusion
representative.
WARNING!
The Infant Flow®LP SiPAP system is compatible only with the Infant Flow
LP Generator. The prescribed nCPAP level will not be obtained if other
variable flow generators are used.

Service Manual 3
675-120 Rev. G
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
Controls
•Inspiratory Time (T-High): 0.1-3.0 seconds
•Rate (R): 1-120 (Comprehensive only. The comprehensive configuration is
not available for sale in the United States.)
•Rate (R): 1-54 (Plus only)
•Apnea Interval (Tapnea): 10-30 seconds, 5 second intervals (Comp* only)
•Apnea Interval (TLBR): 10-30 seconds, 5 second intervals (Plus only)
•NCPAP/Pres Low flowmeter: 0-15LPM, accuracy +/- 15% of selected output
•NCPAP/Pres High flowmeter: 0-5LPM, accuracy +/- 15% of selected output
•Manual Breath: X 1
•Rate monitoring on/off: NCPAP
•%O2: 21 - 100% - accuracy +/-3%
Monitors
•CPAP
•PEEP
•MAP
•PIP
•%O2
•I:E ratio
•Spontaneous rate (Rs)
•Battery charge level

4Infant Flow®LP SiPAP Model M675
675-120 Rev. G
Alarms
•High airway pressure – 3 cmH20 above measured airway pressure
•High circuit pressure – maximum 11 cmH20 in time triggered Biphasic mode
•High circuit pressure – maximum 15 cmH20 in patient triggered Biphasic tr
mode (Comprehensive only. The comprehensive configuration is not
available for sale in the United States.)
•Low airway pressure – 2 cmH20 below measured airway pressure or 1
cmH20 if otherwise would be zero
•High and Low delivered Oxygen concentration +5% of setting
•Low breath rate alarm
•Low or Flat battery charge level
•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:2.8 to 6 bar (40 to 90 psi); maximum differential pressure 2 bar
(30 psi)
•Manometer:Range 0 to + 20 cmH2O, accuracy, ±2% of span
•Gas Connections:Standard DISS or NIST 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

Service Manual 5
675-120 Rev. G
Atmospheric & Environmental
•Temperature Range-Operating: 5 – 40° C
•Storage: 0 - 50° C
•Relative Humidity -Operating: 0 – 90% non-condensing
•Storage: 0 – 90% non-condensing
Physical
•Dimensions (driver only)-(W x H x D) 26 x38 x 23.5 cm /
10.25 x15 x 9.25 in
•Weight (driver only)-8.8 kg / 19.5 lb

6Infant Flow®LP SiPAP Model M675
675-120 Rev. G
Infant Flow®LP SiPAP and SiPAP
Model M675

Service Manual 7
675-120 Rev. G
Chapter 3 – Warnings and Cautions
Please review the following safety information before operating the Infant Flow® LP
SiPAP or SiPAP system. 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 technical support at CareFusion.
Terms
WARNINGS identify conditions or practices that could result in serious adverse
reactions or potential safety hazards.
CAUTIONS identify conditions or practices that could result in damage to the
ventilator or other equipment.
NOTES identify supplemental information to help you better understand how
the ventilator works.
Warnings
•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 problems may
require immediate attention.
•The gas blender incorporated in this product is designed to mix medical
grade air and oxygen only. Do not modify the inlets to accommodate other
source gases such as anesthetic gases.
•Check that the water trap is empty before use and empty it frequently during
use.
•Liquid water or other contaminants in either gas supply, particularly the air
supply, may cause malfunction of this equipment and equipment connected
to it.
•When filling a humidifier, do not move the stand. Moving or transporting the
stand while refilling may cause the stand and equipment to over balance.
•The Infant Flow LP SiPAP system is compatible only with the Infant Flow LP
Generator. The prescribed nCPAP level will not be obtained if other variable
flow generators are used.

8Infant Flow®LP SiPAP Model M675
675-120 Rev. G
•Do not use conductive patient circuits with the Infant Flow®LP SiPAP Driver.
•Nasal CPAP can cause nasal irritation, septal distortion, skin irritation and
pressure necrosis. Observe the usage guidelines to minimize these
complications.
•This device exhausts O2during normal operation. Oxygen vigorously
accelerates combustion. To avoid fire hazard, do not place flammable
materials or sources of heat close to the exhaust.
•Do not use the equipment without the exhaust tube fitted (refer to Figure 2).
•To reduce trip hazard, always ensure cable and tubes are restrained away
from walking areas.
•The Abdominal Respiratory Sensor will not detect all forms of apnea.
Independent monitoring should always be used with this device.
•If the unit is shelf mounted, ensure that the unit is stable and that hoses and
cables are restrained to avoid hazard of toppling.
•This equipment is not suitable for use in the presence of a flammable
anesthetic mixture.
•The NCPAP Pres High flowmeter must be adjusted to zero when not required
for the patient.
•Under extreme conditions (minimum supply pressure and maximum gas
demand, including auxiliary output) output flow rates and delivered pressure
may be reduced.
•Only use the supplied AC cable to connect to the power supply.
•Do not attach the Generator to the patient until the initial set up is complete.
•The indicates a connection between the transducer interface and the
unit. It does not indicate correct positioning of the Abdominal Respiratory
Sensor.
•Calibration must only be done when the unit is not connected to the patient.
•Verify that the displayed value for delivered FiO2corresponds to the value set
on the blender. Refer to Faults and Indications.
•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.
675-120(1) 23/9/03 Page 8 of 60

Service Manual 9
675-120 Rev. G
Cautions
•Federal Law (USA) restricts this device to sale by or on the order of a
physician.
•The precision gas blender in this product may become non-functional or
damaged if used without the protective water trap and filters provided.
•The power switch on this unit does not isolate the external power supply.
Disconnect the power supply cable to ensure complete isolation.
•Before use, verify that this equipment has been authorized for use by a
qualified person.
•The Infant Flow®LP SiPAP and SiPAP systems have been designed and
tested as complete systems using Infant Flow®SiPAP accessories. Only
accessories approved for use should be used. If in doubt, please contact your
local CareFusion representative.
•Where the integrity of the external protective earth conductor is in doubt, the
equipment shall be powered by its internal power source (battery).
•Do not immerse any part of the IFSD in water or sterilize it with gas or steam.
•Ensure patient breathing circuit is replaced at regular intervals.

10 Infant Flow®LP SiPAP Model M675
675-120 Rev. G
Infant Flow®LP SiPAP and SiPAP
Model M675