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Infant Flow LP SiPAP M675
User manual
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CareFusion Infant Flow LP SiPAP M675 User manual

Infant Flow® LP SiPAP and SiPAP Model M675

Service manual

ii Infant Flow
®
This document is protected by United States and International Copyright laws.
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
carefusion.com
Literature number: 675–120 Revision G
+49.931.4972.0 tel
+49.931.4972.423 fax
675–120 Rev. G
Service Manual iii
September 2003
675-120(1)
Release
page 88.
Update list of service parts
Updated Table 6 starting on page 43

Revision History

Date Revision Changes
November 2004 B
December 2004 C
May 2005 D
Release manual in VIASYS Healthcare template using VIASYS Healthcare Respir ator y Care nomenclature.
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
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
August 2008 E
675-120 Rev. G
Updated company information Updated company information Corrected Table 2 and updated Table 3 Updated Figure 6 Updated Figure 10 Updated the section “Diagnostics.”
iv Infant Flow
FRONT”
Model M675
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-
®
May 2011 G
Added instructions and specifications for LP SiPAP
675-120 Rev. G
Service Manual v

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 followin g t he 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 connect ion 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 fr om 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.
675-120 Rev. G
vi Infant Flow
®

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
E
lectrical Layout ........................................................................................................ 23
Fault Management ..................................................................................................... 24
675-120 Rev. G
Service Manual vii
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 O
Leak Test ................................................................................................................... 32
Alarms Test ................................................................................................................ 33
Infant Flow
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
Sensor Calibration ................................................................................ 31
2
®
LP SiPAP/SiPAP User Verification Test Checklist .................................. 35
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
R
emoval 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 – Oxy g en Leak Test.............................................................................. 75
Appendix B – Produc t C on fig ur ati ons ...................................................................... 79
Non-US Configuration Parameters ............................................................................. 79
US Configuration Parameters .................................................................................... 79
Appendix C – Spare Parts ....................................................................................... 81
Appendix D – Pneumatics Assembly ....................................................................... 83
Glossary ................................................................................................................... 85
675-120 Rev. G
viii Infant Flow

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.
675-120 Rev. G
Service Manual ix

Intended Use Not ice

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 Se rvice En gineers 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 w or ks. It also contains operating and diagnostic procedures and maintenance instructions. For usage of associated equipment, refer to the Manufacturer’s literature.

Regulatory No t ice

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.
675-120 Rev. G
x Infant Flow

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.
675-120 Rev. G
Service Manual 1

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 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 standard in all configurations with an LCD touch screen display, pressure time waveform graphics, integrated patient monitoring, alarms for high and low pressure and FiO
and up to 2 hours of backup battery power.
2
As a result of the unique, patented design, the Infant Flow systems have been proven to provide the most stable CPAP at the lowest work-of­breathing for patients compared to other devices. The outstanding 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.
®
LP SiPAP and SiPAP systems are currently available in the Plus or
®
LP SiPAP and SiPAP systems come
®
LP SiPAP and SiPAP
®
LP SiPAP and SiPAP systems is irrespective of patient demand or
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
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.
®
LP Generator. The Infant Flow® LP Generator is a fluidic
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.
675-120 Rev. G
2 Infant Flow
NCPAP
•
•
NCPAP with breath rate monitoring and alarm
• •
BiPhasic
•
•
and alarm
• •
BiPhasic tr*
•
Internal Battery
•
•
Manual Breath
•
•
Apnea Back up rate
•
Screen lock
•
•
Prioritization of alarms
•
•
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. T he 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*
®
BiPhasic with breath rate monitoring
*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.
675-120 Rev. G
Service Manual 3

Chapter 2 – Product Specifications

Modes

• NCPAP
• NCPAP with breath rate monitoring and low rate alarm
• BiPhasic (t im e triggered)
• BiPhasic (t im e 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 Inter val (T
• Apnea Inter val (T
• 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
• %O

Monitors

• CPAP
• PEEP
• MAP
• PIP
• %O
• I:E r a ti o
apnea): 10-30 seconds, 5 second intervals (Comp* only) LBR): 10-30 seconds, 5 second intervals (Plus only)
: 21 - 100% - accuracy +/-3%
2
2
• Spontaneous rate (Rs)
• Battery charg e level
675-120 Rev. G
4 Infant Flow

Alarms

• High airway pressure – 3 cmH20 above measured airway pressure
• Hig h cir cuit pressure – maximum 11 cmH20 in time triggered Biphasic mode
• Hig h cir cuit 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
• Hig h and Low delivered Oxygen concentration +5% of setting
• Low breath r ate 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 cmH
• Gas Connecti ons: 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 Prot ection rating level: IPX1
• Battery Worki ng Time: 2 hours (from fully charged state)
• Battery Charging Time: max. 16 hours
O, accuracy, ± 2% of span
2
675-120 Rev. G
Service Manual 5

Atmospheric & Environmental

• Temperatur e Range-Operating: 5 – 40° C
• Storage: 0 - 50° C
• Relative Humidit y -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
675-120 Rev. G
6 Infant Flow
®
Infant Flow
LP SiPAP an d SiPAP
Model M675
®
675-120 Rev. G
Service Manual 7

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

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 f illing a humidifier, do not move the stand. Moving or transporting the
stand while refilling may cause the stand and equipment to over balance.
the ventilator works.
• The Infant Flow LP SiPAP system is compatible only with the Infant Flow LP
675-120 Rev. G
Generator. The prescribed nCPAP level will not be obtained if other variable flow g ener ators are used.
8 Infant Flow
• 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 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.
• 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 extr eme 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 m ust only be done when the unit is not connected to the patient.
• Verif y that the displayed value for delivered FiO
corresponds to the value set
2
on the blender. Refer to Faults and Indications.
• Oxygen vigor ously 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 Rev. G
Service Manual 9

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, verif y that this equipment has been authorized for use by a
qualified person.
• The Infant Flow
tested as complete systems using Infant Flow accessories approved for use should be used. If in doubt, please contact your local CareFusion representative.
• Where the integrit y 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.
®
LP SiPAP and SiPAP systems have been designed and
®
SiPAP accessories. Only
• Ensure patient breathing circuit is replaced at regular intervals.
675-120 Rev. G
10 Infant Flow
®
Infant Flow
LP SiPAP and SiPAP
Model M675
®
675-120 Rev. G
Service Manual 11

Chapter 4 – System Construction

CAUTION!
Where the integrity of the external protective earth conductor is in doubt the equipment shall be powered by its internal power source (battery).
The IFSD is AC powered with an integral rechargeable DC battery that provides power for up to two hours without any interruption of performance or function. If the AC power supply fails or is disconnected, the IFSD automatically switches to battery power and gives an audio and visual alarm.
The IFSD is enclosed in a case with Operator controls and input connectors on the front and rear panel. The front panel is shown in Figure 1. The back panel is shown in Figure 2. The case incorporates non slip feet for table top use or must be fitted to a dedicated stand. The major components within the casing are:
• a gas module
• an electronics module
• a front panel module
• a patient trigger module
• a firmware module
675-120 Rev. G
12 Infant Flow
®
Figure 1: IFSD Front Panel

Gas Module

The function of the gas module is to take air and oxygen, blend them into the required mixture and deliver this mixture to the patient at the prescribed flow rat e. The gas module also measures the oxygen concentration, measures the patient pressure, provides an auxiliary gas outlet (optional) and provides switched Biphasic flow.
The main components are an air/oxygen blender, a flow manifold, a vent valve, an exhaust manifold with alarm whistle, NCPAP Pres low and NCPAP Pres high flowmeters, and a valve/sensor PCB. The inlet gas connections are on an interc han geable i nlet bl ock to allow for different gas fittings. The exhaust manifold discharges gas to the outside of the case and is positioned away from the electrical connectors and switch to reduce any potential explosive hazard.
675-120 Rev. G
Service Manual 13
Leak Test

Electronics Module

The function of the electronics module is to power the unit either by AC mains supply or DC emergency battery supply, to control the gas module and read the gas module sensors. The main components are a power supply unit, a rechargeable batt ery, a main processor PCB, LED PCB, Valve/Sensor PCB and a LCD screen (touch screen). The LCD screen includes a back-light which is always on when the IFSD is powered. The touch screen displays information and receives inputs from the Operator via the touch screen keyboard.
Figure 2: IFSD Back Panel
Port
675-120 Rev. G
14 Infant Flow
®
Figure 3: IFSD Internal Components
675-120 Rev. G
Service Manual 15

Front Panel Module

The function of the front panel module is to house the gas and electrical connections to the patient, Operator controls and indicators. The module consists of a front panel plate, the touch screen with key pad, flowmeters and FiO and indicators and an ambient light sensor. The backlight on the touch screen is decreased if the ambient light sensor detects a low ambient light level and increased if it detects a high ambient light level.
The green Power light is always on when AC power is connected to the unit.
control, patient connectors
2
The Alarm Warning Bar

Patient Trigger Module (P lus and Comprehensive Models)

The patient trigger module consists of a PCB which plugs into the main processor PCB. Its function is to detect patient breaths and apnea and give this information to the main processor in the electronics module. The main processor uses the signals from the patient trigger module to instruct the biphasic pressure control to provide a timed sigh to the patient.

Firmware Module

The firmware module is the unit’s embedded software. Its function is to instruct the microprocessor how to control the unit and to interact with the Operator.

Touch Screen

The touch screen provides the Operator with a series of screens with icons to enable settings, calibration and fault diagnosis. The Start Up Screen is shown in Figure 4. The display includes a status bar which incorporates a battery status, mode indicator, alarm button and patient trigger indicator. The center part of the display shows icons which relate to the function being selected or performed. The display also includes a key pad with six keys. The icon in each key changes depending on the function being performed.
flashes red to indicate an alarm.

Battery Status and Chargi ng Indicator

If the battery status shows three bars or less, the display flashes alternately between red bars on a white background and a pink background.

Alarm Button

The alarm button alerts the Operator to fault conditions. An audible alarm is activated at the same time. In the unalarmed condition the button is green high-priority alarm condition, the button flashes
heard. If the alarm button is pressed (to silence the audible alarm), the button changes to flashes condition, the button is solid
675-120 Rev. G
. In the
red and an audible alarm is
and flashes red. In a medium-priority alarm condition, the button
yellow and an audible alarm is heard. In a low-priority alarm
yellow with an audible alarm. If any alarm
16 Infant Flow
condition resets itself, the yellow alarm bar remains to alert the clinician of a previous problem.

Caution/Information

The Caution/Information icon alerts the Operator to read this manual. It flashes during an alarm condition.

Mode Indicator

The Mode Indicator shows four question marks when in Start up or Adjust and changes to show the applicable mode in use (e.g. NCPAP).
®
Figure 4: Touch Screen Display – Start Up

Patient Trigger Indicator (Plus and Comprehensive Models)

The Patient Trigger indicator changes to when the transducer interface is connected and ready to be connected to the patient and indicates a
transducer interface is not connected.
when the
675-120 Rev. G
Service Manual 17

Alarm Conditions

Audible and visible alarm indications are given to alert the Operator to specified conditions that affect the operation of the unit. The electronic alarm limits are automatically set after two minutes without Operator inputs but the Operator can manually set the alarm parameters for certain conditions if required. The IFSD has the following alarms:
• an audible W histle which sounds a constant tone when the gas imbalance
limits are exceeded.
• an audible Alarm which sounds a constant tone or two different intermittent
tones; medium or high level (medium level sounds beep.beep.beep every 15 seconds and high level sounds beep .beep .beep beep beep every 10 seconds).
• a visual Warning Bar which flashes red continuously, flashes intermittently or
comes on continuously.
• an Al arm Button on the touch screen status bar which flashes continuously.
Other indications are given to indicate the status of the condition. Refer to Table 2 for alarms and indications for specified conditions.

Diagnostic Screen

A diagnostic screen is provided for low level calibration, test procedures for valves and an error log. Figure 5 shows the screen display. Labeling of Diagnostic screen
will be the same regardless of configuration.
Figure 5: Diagnostic Screen
675-120 Rev. G
18 Infant Flow
Box
Description
PCB. Position 1 is on and 0 is off.
INDICATOR
contrast.
successfully completed and a if the calibration fails.
Box
Description
S/W
The S/W box shows the version and serial number of the loaded firmware.
(E2P).
PT
The PT box shows the status of the Patient Trigger module.
inspiratory time, and breath rate (controlled by DIP 1).
(BLL) and if the backlight is operative (BLF - 1 for fail, O for on).
(BAT), the battery charge status (CHG) and the temperature (TMP).
8.2 and 10 V).
RS232
The RS232 box shows factory set data.
values.
(OSEN) and the software offset (OFFS) and gain (GAI N) values.
for the zero valve and the Z sensor (ZSEN) voltage.
for the dump valve and the D sensor (DSEN) voltage.
for the pressure assist valve and the P sensor (PSEN) voltage.
Table 2 - Diagnostics Screen Boxes
DIPS The DIPS box shows the position of the DIP switches on the main processor
®
CONTRAST
CALIBRATION INDICATOR
The contrast indicator box is for use in the factory for setting the screen
The calibration indicator box shows
during calibration, a when
The following display boxes show if the values are within t he set parameters, a
if the values are outside the set parameters, a if the function is not
calibrated and a
if the function is disabled on the DIP switch.
Table 3 - Additional Diagnostics Screen Boxes
H/W The H/W box shows the status of the watchdog t i mer (WDG) and the EEPROM
CONFIG The CONFIG box shows the softw are con figurati on based on the DIP swit ch
settings and requirements. LAB = INTL or US (controlled by DIP 3), which is the Comprehensive or Plus model; tBiP = 1 or 0 (controlled by DIP 2 and 5), which indicates Triggered BiPhasic is enabled (1) or disabled (2); APB = 1 or 0 (controlled by D IP 2 ), w hi ch in dicates that Apnea BiPhasic is enabled (1) or disabled (0 ); The re maining sy mbols provi de the de fault and r ange s for
LCD The LCD box shows the ambient light sensor voltage (AMB), the back light level
PSU The PSU box shows the external power supply voltage (EXT), the battery voltage
RAILS The RAILS box shows the ground voltage (GND), and the control voltages (6.5,
PRESSURE The PRESSURE box shows cm H2O pressure value, the voltage from the
pressure sensor (PSEN) and the software offset (OFFS) and gain (GAIN)
OXYGEN The OXYGEN box shows the FiO2 %, the voltage from the oxygen sensor
ZVALVE The ZVALVE box shows if the Z DRIVE is operative (ZDRV - 1 for fail, O for on)
DVALVE The DVALVE box shows if the D DRIVE is operative (DDRV - 1 for fail, O for on)
PVALVE The PVALVE box shows if the P DRIVE is operative (PDRV - 1 for fail, O for on)
675-120 Rev. G
Service Manual 19

Chapter 5 – Theory of Operation

Gas Flow

With the oxygen and air connections connected and the power switch ed on, oxygen and air at 386 kPa (56 psig) flows to the blender. The air passes thr ough a water trap with an integral filter where any moisture in the air is removed. Oxygen and air are filtered before entering a non-return valve in the blender. The blender mixes the oxygen and air in the proportion set by the position of the FiO blender supplies blended gas between 2.5 and 30 LPM.
The blender incorporates an alarm/bypass module. If a single gas supply fails or there is an imbalance between the inlet gas pressures exceeding 200 kPa (30 psig), the module directs the flow through a reed whistle to warn the Operator of the condition and at the same time connects the inlet gas at the hig her pressure to the blender outlet.
The blended gas is filtered before passing through a flow control to an oxygen analyzer. The oxygen analyzer utilizes a galvanic fuel cell to measure and display the measured delivered oxygen concentration.
control valve. The
2
A vent valve on the exhaust manifold incorporates a solenoid operated pilot valve and a large orifice spool valve. The vent valve is normally held in the open position by a spring to vent high flow rates with low pressure drops so that the patient pressure is minimal. The electrically actuated pilot valve is operated by blended gas so that the vent valve continues to operate if one gas supply is lost.
Blended gas flows through an electronically operated dump valve which is normally in the closed position. If over pressurization occurs, the sensors detect the condition and the controller signals the dump valve to open, sounds an alarm buzzer and at the same time closes the vent valve to rapidly reduce the patient pressure to near zero. When the over pressure condition stops, the controller signals the vent valve to open and the dump valve to close.
The NCPAP flowmeter is set by the Operator to the required flow. The flow rate is shown on the gauge on the flowmeter. When the flowmeter control knob is turned fully clockwise, the flow of gas is turned off.
675-120 Rev. G
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