CareFusion M675 Service Manual

Service Manual

®

Infant Flow

Model M675

SiPAP

© Copyright 2004, VIASYS Healthcare Critical Care

675-120 Revision C November 2004

2 Infant Flow

®

SiPAP

675-120 Revision C November 2004

Service Manual 3

Revision History

Date Revision Pages Changes

September 2003 675-120(1) All Release

November 2004 B All Release manual in VIASYS Healthcare

template using VIASYS Healthcare Critical
Care nomenclature.

December 2004 C Title page, 19,

30, 39, 45, 50,
56, 57, 61, 62,
64, 65, 68, 69,
73, 75, 81–83,
86, 87, 88

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.

675-120 Revision C November 2004

4 Infant Flow

Contact and Ordering Information

United States, Latin America, Asia Pacific:

Sales, Service and Clinical Support:
VIASYS Healthcare
Critical Care Division
22705 Savi Ranch Parkway
Yorba Linda, CA 92887
Phone: [phone]
[phone]
Fax: [phone]
www.VIASYShc.com

United Kingdom:

Sales, Service and Clinical Support:
VIASYS Healthcare
3 Welton Rd.
Warwick,
CV34 5PZ
Phone: [phone]
Fax: [phone]

®

SiPAP

Europe
Sales and Customer Service Technical Service

VIASYS Healthcare VIASYS Healthcare
Critical Care Division Leibnizstrasse 7
22705 Savi Ranch Parkway D-97204 Hoechburg
Yorba Linda, CA 92887 Germany
Phone: [phone] Phone [phone] – 0
[phone] Fax:[phone]
e-mail: [e-mail]
website: www.VIASYShc.com

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Service Manual 5

Warranty

The Infant Flow® SiPAP is warranted to be free from defects in material and
workmanship and to meet the published specifications for One (1) year from date of
shipment.

The liability of VIASYS Healthcare, Critical Care Division, (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.

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6 Infant Flow

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SiPAP

Contents

Revision History.................................................................................... 3

Contact and Ordering Information ...................................................... 4

Warranty ................................................................................................ 5

Limitation of Liabilities ...................................................................................................5

Contents ................................................................................................ 6

Notices................................................................................................... 8

Copyright Notice............................................................................................................ 8

Trademark Notices........................................................................................................8

EMC Notice ...................................................................................................................8

MRI Notice.....................................................................................................................9

Intended Use Notice...................................................................................................... 9

Regulatory Notice..........................................................................................................9

Classification .................................................................................................................9

Declaration of Conformity Notice.................................................................................10

Chapter 1 - Product Description........................................................ 12

Infant Flow® SiPAP Features.............................................................. 12

Chapter 2 - Product Specifications ................................................... 14

Modes..........................................................................................................................14

Controls.......................................................................................................................14

Monitors.......................................................................................................................14

Alarms .........................................................................................................................15

Pneumatic Supply........................................................................................................15

Electrical Supply.......................................................................................................... 15

Atmospheric & Environmental.....................................................................................16

Physical.......................................................................................................................16

Chapter 3: Summary of Warnings and Cautions ............................. 18

Terms ................................................................................................... 18

Warnings .....................................................................................................................18

Cautions ......................................................................................................................20

Chapter 4: System Construction....................................................... 22

Touch Screen..............................................................................................................26

Alarm Conditions.........................................................................................................27

Diagnostic Screen .......................................................................................................28

Chapter 5 - Operation ......................................................................... 30

Gas Flow .....................................................................................................................30

Electronic Functions....................................................................................................32

Electrical Layout..........................................................................................................33

Fault Management.......................................................................................................34

Chapter 6 - Operation ......................................................................... 36

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Service Manual 7

Preparing and Connecting the Equipment...................................................................36

Setting Up the Equipment............................................................................................40

Setting the NCPAP Parameters...................................................................................41

Setting the BiPhasic Parameters.................................................................................42

Setting the Triggered BiPhasic Parameters.................................................................43

Calibration....................................................................................................................44

Giving a Manual Timed Sigh........................................................................................45

Operation Without Electrical Power.............................................................................45

Fault Indications...........................................................................................................45

Diagnostics..................................................................................................................52

Chapter 7- Maintenance......................................................................60

Cleaning ...............................................................................................60

Maintenance.........................................................................................60

General........................................................................................................................60

Maintenance Frequencies ...........................................................................................61

Removal and Fitting of Case .......................................................................................62

Removal and Fitting of Battery ....................................................................................62

Removal and Fitting of Oxygen Filter ..........................................................................65

Removal and Fitting of Fuel Cell Filter/Restrictor........................................................66

Removal and Fitting of the Fuel Cell............................................................................67

Removal and Fitting of Blender and Components.......................................................68

Removal and Fitting of Water Trap Filter.....................................................................71

Removal and Fitting of Case Bleed Filtered Restrictor................................................72

Removal and Fitting of PA Solenoid Valve..................................................................73

Firmware Reload/Upgrade...........................................................................................73

Testing.........................................................................................................................74

Chapter 8 – Explanation of Symbols.................................................75

Symbols used on buttons...................................................................77

Appendix A- Oxygen Leak Test..........................................................79

Appendix B- Product Configurations................................................82

Non-US Configuration Parameters.....................................................82

US Configuration Parameters................................................................82

Appendix C - Spare Parts.................................................................83

Additional Service Parts.....................................................................84

Glossary...............................................................................................87

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8 Infant Flow

Notices

Copyright Notice

Copyright © 2004 VIASYS Healthcare, Critical Care Division, California.
This work is protected under Title 17 of the U.S. Code and is the sole property of the

Company. No part of this document may be copied or otherwise reproduced, or
stored in any electronic information retrieval system, except as specifically permitted
under U.S. Copyright law, without the prior written consent of the Company. For
more information, contact:

World Headquarters European Office

1100 Bird Center Drive Rembrandtlaan 1b
Palm Springs, CA 92262-8099 3723 BG Bilthoven
U.S.A. P.O. Box 299, 3720 AG Bilthoven
Phone: [phone] The Netherlands
[phone] Phone: [phone]
Fax: [phone] Fax: [phone]
www.VIASYSCriticalCare.com

®

SiPAP

Trademark Notices

Infant Flow® and SiPAP are trademarks of VIASYS Healthcare, Critical Care Division
in the U.S. and some other countries. All other brand names and product names
mentioned in this manual are trademarks, registered trademarks, or trade names of
their respective holders.

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

675-120 Revision C November 2004

Service Manual 9

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.

Intended Use Notice

The Infant Flow® SiPAP, 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 intra­Hospital transport environments and is indicated for the treatment of Newborn and
Infant patients.

Ope r a t o r s o f t h i s e q u i p m ent and S ervice E n g i neers 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.

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10 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

®

SiPAP

EU Notified Body:

BSI (Reg. No. 0086)
Trade names:
Infant Flow SiPAP

Manufactured by:

SensorMedics Corporation
22705 Savi Ranch Parkway
Yorba Linda, CA 92887, USA

If you have a question regarding the Declaration of Conformity for this product,
please contact VIASYS Healthcare, Critical Care Division.

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Service Manual 11

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12 Infant Flow

Chapter 1 - Product Description

The Infant Flow® SiPAP is a non-invasive form of respiratory support designed for
use in hospital environments such as Neonatal and Pediatric Intensive Care Units. It
can also be used when transporting patients within the hospital environment.

The 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 patient BiPhasic mode with apnea backup breaths. The
Infant Flow
display, pressure time waveform graphics, integrated patient monitoring, alarms for
high and low pressure and FiO

As a result of the unique patented design, the Infant Flow
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
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
VIASYS Healthcare, Inc. 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 LCD touch screen

and up to 2 hours of backup battery power.

2

®

SiPAP has been proven

®

®

SiPAP

SiPAP

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.

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

the generation of consistent infant nasal CPAP with a low work of breathing
compared to other 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.

Generator - The Infant Flow® Generator is a fluidic device for

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.

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Service Manual 13

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 SiPAP™ has been designed and tested as a complete system using
Infant Flow™ accessories. Only accessories approved for use should be used. If in
doubt, please contact your local VIASYS representative.

• •

• •

• •

• •

• •

• •

• •

• •

•

•

675-120 Revision C November 2004

14 Infant Flow

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 (Ti) – 0.1-3.0 seconds

• Rate (R) – 1-120 (Comprehensive* only)

®

SiPAP

• Rate (R) – 1-54 (Plus only)

• Apnea Interval (T

• Apnea Interval (T

• NCPAP/Pres Low flow meter – 0-15L/min, accuracy +/- 15% of selected

output

• NCPAP/Pres High flow meter – 0-5L/min, accuracy +/- 15% of selected

output

• Manual Breath – X 1

• Rate monitoring on/off – NCPAP

• %O

Monitors

• CPAP

• PEEP

• MAP

• PIP

apnea) – 10-30 seconds, 5 second intervals (Comp* only)
LBR) – 10-30 seconds, 5 second intervals (Plus only)

– 21 - 100% - accuracy +/-3%

2

• %O

• I:E ratio

• Spontaneous rate (Rs)

• Battery charge level

675-120 Revision C November 2004

2

Service Manual 15

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

• 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

• 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, clean, dry medical air and oxygen

• Range - 2.8 - 6 bar; Maximum differential pressure 2 bar

• 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

675-120 Revision C November 2004

16 Infant Flow

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

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SiPAP

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Service Manual 17

675-120 Revision C November 2004

18 Infant Flow

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SiPAP

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 VIASYS Healthcare Customer Care.

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.

ventilator or other equipment.

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.

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Service Manual 19

• 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.

• Do not use conductive patient circuits with the Infant Flow 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 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.

• Ensure the whistle sounds during gas connection. If not, the device may be

faulty and should not be used. Refer to your Service Engineer.

• Verify that the displayed value for delivered FiO
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 Revision C November 2004

corresponds to the value set

2

20 Infant Flow

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 SiPAP™ has been designed and tested as a complete
system using Infant Flow™ accessories. Only accessories approved for use
should be used. If in doubt, please contact your local VIASYS 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.

®

SiPAP

• Ensure patient breathing circuit is replaced at regular intervals.

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Service Manual 21

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22 Infant Flow

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

®

SiPAP

• a front panel module

• a patient trigger module

• a firmware module

675-120 Revision C November 2004

Service Manual 23

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 rate.
The gas module also measures the oxygen concentrat ion, m easures th e patie nt
pressure, provides an auxiliary gas outlet (optional) and provides switched Biph asic flow.

The main components are an air/oxygen blend er, a f low manifold, a vent v alve, 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 interchangeable inlet block
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 Revision C November 2004

Figure 1 - IFSD Front Panel

24 Infant Flow

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 battery, 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.

®

SiPAP

Figure 2 - IFSD Back Panel

Ground test
point

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Service Manual 25

Figure 3 -IFSD Internal Components

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26 Infant Flow

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

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SiPAP

The Alarm Warning Bar

Patient Trigger Module (Plus 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 a nd apne a and giv e 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 perfo rmed. The display al so
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 Charging 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
alarm is heard. If the alarm button is pressed (to silence the audible alarm), the

button changes to
the button flashes

675-120 Revision C November 2004

. In the

red and an audible

and flashes red. In a medium-priority alarm condition,

yellow and an audible alarm is heard. In a low-priority

Service Manual 27

alarm condition, the button is solid yellow with an audible alarm. If any
alarm 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

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:

675-120 Revision C November 2004

28 Infant Flow

• an audible Whistle 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 Alarm 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.

®

SiPAP

675-120 Revision C November 2004

-

Figure 5 - Diagnostic Screen

Service Manual 29

Table 2 – Diagnostic Screen Boxes

Box Description

DIPS The DIPS box shows the position of the DIP switches on the main processor

PCB. Position 1 is on and O is off.

CONTRAST
INDICATOR

The contrast indicator box is for use in the factory for setting the screen
contrast.

CALIBRATION
INDICATOR

The calibration indicator box shows

during calibration, a when

successfully completed and a

if the calibration fails.

The following display boxes show if the values are within the 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 Diagnostic Screen Boxes

Box Description

S/W The S/W box shows the version and serial number of the loaded firmware.
H/W The H/W box shows the status of the watchdog timer (WDG) and the EEPROM

PT The PT box shows the status of the Patient Trigger module.
LCD The LCD box shows the am bient light sensor volt age (AMB), the back light lev el

PSU The PSU box shows the external power supply voltage (EXT), the batt ery voltage

RAILS The RAILS box shows the ground voltage (GRD), and th e control voltages (6.5,

RS232 The RS232 box shows factory set data.
PRESSURE The PRESSURE box shows cm H

FLOW The FLOW box shows the flow rate (LPM), the voltage from the flow 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 PV ALVE box sho w s i f t h e P D R I V E i s operative (PDRV - 1 for fail, O for on)

2

(E

P).

(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).

O pressure value, the voltage from the

2

pressure sensor (PSEN) and the software offset (OFFS) and gain (GAIN)
values.

(FSEN) 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.

675-120 Revision C November 2004

30 Infant Flow

Chapter 5 - Operation

Gas Flow

With the oxygen and air connections connected and the power switched on, oxygen
and air at 386 kPa (56 psig) flows to the blender. The air passes through 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 L/min.

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 higher 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

®

SiPAP

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.

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Service Manual 31

Figure 6 - IFSD Gas Flow Schematic

The patient pressure is shown on the touch screen and is monitored by a pressure
sensor which sends the signal to the main processor. A zeroing valve automatically
checks the pressure readings against atmospheric pressure to ensure accuracy of
the patient pressure readings.

A mechanical pop-off valve is factory set to limit the delivered pressure to a safe
level sufficient to achieve the maximum required patient pressure at the generator.
Adjustment of the pop-off valve is not required by Operators.

Auxiliary Output (Optional)

Blended gas flows through a fixed flow control and non-return valve to a standard
DISS fitting on the back panel to supply a maximum 15 L/min for delivery to the
patient via other sources.

Inspiratory Pressure

Blended gas passes through a variable outlet flow control and through the NCPAP
Pres high flowmeter. The NCPAP Pres high flowme t e r is set by the Oper a t o r t o t h e
required flow. The outlet from the NCPAP Pres high flowmeter when not delivering to
the patient flows through a restrictor to exhaust, allowing the flowmeter to be
adjusted without delivering gas to the patient. 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. The flow is directed to the patient via a high speed selector valve
which operates when requested by the NCPAP Pres high timing.

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32 Infant Flow

WARNING

The NCPAP Pres high must be adjusted to zero when not required for the
patient.

Triggered BiPhasic

For BiPhasic Tr, a micro controller provides reliable indications of breaths derived
from the patient abdominal respiratory sensor. It sends signals to operate the
NCPAP Pres high valve to provide a timed sigh.

WARNING

Under extreme conditions (minimum supply pressure and maximum gas
demand, including auxiliary output) output flow rates may reduce.

Operation Without Electrical Power

The IFSD can be used without electrical power. In this mode, NCPAP Pres low flow
only is delivered, set by the NCPAP Pres low flowmeter and the required FiO
this mode, visual indications and warnings are not given except for the gas failure
alarm.

®

SiPAP

level. In

2

Electronic Functions

Sensors mounted on the valve/sensor PCB monitor pressure, flow rate and oxygen.
Sense signals for each of the valves allow the micro-controller to monitor the valve’s
state and determine whether the valve is connected or short circuited. Current to the
valve sensor PCB is limited via the fuses below a 10 VA limit to ensure safety in a
possible oxygen enriched environment.

The patient trigger PCB interfaces with the main processor PCB via a 20 way head.
Communication between the two PCB’s is via a CAN bus. The main processor PCB
also supplies +5 V power to this PCB and monitors other control signals.

675-120 Revision C November 2004

Service Manual 33

Figure 7 - IFSD Electronic Enclosure

Electrical Layout

Figure 8 shows the electrical wiring and PCB connector layout.

675-120 Revision C November 2004

Figure 8 - IFSD Electrical Wiring Diagram

34 Infant Flow

Fault Management

When a software detectable fault condition occurs, the unit still allows a basic level of
treatment to the patient. Table 4 shows the fault conditions and the level of control
available.

Table 4 - Faults, Available Modes and Control Functions

Measurements Software Control Modes

®

SiPAP

Alarm Functionality FiO2 CmH2O NCPAP

Fault lockout
screen shows
error
code(s).

Error code(s)
shown
on mode
selection
screen. Status
bar
mode
alternates with

Error code(s)
shown
on mode
selection
screen. Status
bar
mode

Battery status
shows
discharged
battery.

Unit inoperable by
software, operable in
unpowered
pneumatic

Unit restricted to
NCPAP and
NCPAP+Apnea
modes.

Patient trigger
(NCPAP+Apnea,
BiPhasic+Apnea and
BiPhasic Tr) modes
not
available.

Unit will not operate
on battery power
when external power
supply is removed.

X X X X X X

3 3 3 3

3 3 3

3 3 3 3 3 3

NCPAP+

Apnea

X

BiPhasic

+ Apnea

BiPhasic

Tr

X X

3

X

675-120 Revision C November 2004

Service Manual 35

675-120 Revision C November 2004

Service Manual 36

Chapter 6 - Operation

The operating procedures below show the procedures for all models. Reference
should only be made to the procedures for the model in use. Read the Warnings and
Cautions at the beginning of this manual before you start the procedures.

Preparing and Connecting the Equipment

WARNING

Ensure the whistle sounds during gas connection, if not the device may be
faulty and should not be used.

1 Connect the Medical Air and Oxygen hoses to the IFSD connections on the

back panel.

Note

The gas failure alarm/bypass warning whistle sounds until the pressures balance.

WARNING

Only use the supplied AC cable to connect to the power supply.

2 Connect the power supply cable to a suitable power supply outlet. The green

power light will come on regardless of the position of the power switch.

3 Connect the patient circuit to the IFSD as required. Figure 9 shows a typical

configuration, the actual configuration may vary dependent on the type of ancillary
equipment used and the clinical needs prescribed for the patient. For functional
test purposes, the Generator nasal prongs can be occluded to simulate patient
responses.

4 Connect the transducer module to the sensor and to the IFSD. For functional

test purposes, lightly tap the abdominal respiratory sensor to simulate patient
breathing.

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Service Manual 37

WARNING

Check that the water trap is empty before use and empty it frequently during
use.

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Figure 9 - Patient Connections

38 Infant Flow

5 Make sure that the water trap is empty. If necessary, empty any water from the

trap (refer to Chapter 3, Maintenance).

6 Gas Flow Pressure Setting
The IFSD provides a virtually constant airway pressure irrespective of patient

demand or expira t ory flow s v ia the sp ecially d e s igned ge n e rator an d n asal pro n g s . T h i s
is the reason for the IFSDs ability to provided superior NCPAP. The IFSD is subject
to a direct relationship between controlled enriched gas flow and NCPAP pressure.

A nomogram illustrating the relationship between constant airw ay pressure and flow
settings is shown in Figure 10. Example: 8 L/min gas flow provides 5 cm H

2

O

NCPAP.

Note

Individual devices have a tolerance of up to ± 10% from that illustrated in the
nomogram and in particular, at pressures below 2 cm H

2

O.

®

SiPAP

675-120 Revision C November 2004

Figure 10 - Flow Pressure Nomogram

Service Manual 39

Switching On the IFSD

WARNING

Do not attach the Generator to the patient until the initial set up is complete.

Put the power switch on the back panel to the position.

• the warning bar comes on

• the green power light remains on

• the audible alarm sounds

The unit carries out a full functional check. If the checks are not successful (program
memory fault, power supply not connected or emergency battery voltage low), the
screen remains black and the warning bar stays on.

If the checks are successful, the warning bar goes off and the screen changes to the
Power Up Screen.

After two seconds the screen changes to the Power Up Check Screen.
During the power up checks:

• the screen image is shown in negative

• the warning bar comes on for one second

• the Apnea light comes on for one second

• the audible alarm sounds for one second

• the dump valve is tested

• the pressure is set to zero

After two seconds the screen changes to the Start Up Screen.

• the alarm limits are disabled

A flashing question mark alternating with a red cross appears under the first
adjustment to be made.

To calibrate

the O2 fuel cell, refer to Page 42.

Note

Where a mode is not applicable (e.g. Patient Trigger), the button is blank and the
icons are not shown.

675-120 Revision C November 2004

40 Infant Flow

Setting Up the Equipment

The procedures show the screen set up for all modes. If a mode is not applicable to
the model in use, go to the next applicable step.

Adjust the NCPAP Pres low flowmeter to indicate the required flow rate. When done,

®

SiPAP

touch the flashing
The button icon changes to a

Set the FiO
confirm each time.

and NCPAP Pres high flow as appropriate, touching the button to

2

button to confirm the initial setting

and the next button starts flashing.

WARNING

Ensure that the pressure is consistent with the flow rate.

WARNING

Verify that the displayed value for delivered FiO2 corresponds to the value set
on the blender. Refer to Faults and Indications.

If an alarm is activated, the button displays a flashing cross. The alarm condition
must be cleared before the setting is confirmed (refer to Table 1).

WARNING

The indicates a connection between the transducer interface and the unit.
It does not indicate correct positioning of the abdominal respiratory sensor.

Note

All triggered modes (NCPAP+Apnea, BiPhasic+Apnea, BiPhasic Tr) are
automatically confirmed with a

When all of the initial settings have been confirmed (NCPAP Pres low, FiO2, NCPAP
Pres high and/or Respiratory sensor) the screen changes to the Adjust Screen.

• the alarm limits remain disabled

To set the alarm limits, touch the NCPAP button or the alarm button for three
seconds. If a button is not touched within two minutes, the alarm limits will be
automatically set.

Note

NCPAP+Apnea, BiPhasic+Apnea, BiPhasic Tr selection buttons are not lit if the
transducer interface box is not connected to the IFSD.

675-120 Revision C November 2004

if the patient trigger is connected.

Service Manual 41

When the alarm limits have been set, the screen changes to the Mode Selection
Screen and defaults to the nCPAP mode.

• the alarm limits are set

Touch NCPAP, NCPAP+Apnea, BiPhasic, BiPhasic+Apnea, or BiPhasic Tr to enter
the Parameter Set up Screen for each mode.

Note

When the Mode Selection screen is showing, NCPAP treatment will always be
delivered.

After two minutes if the Operator has not made any inputs, the screen changes to the
Locked Screen.

• the key pad is locked

• the display remains as shown for patient monitoring

Touch the

• the display returns to the Mode Selection Screen

button for three seconds to unlock the key pad.

Note

If a high priority alarm occurs, the keypad automatically unlocks.

Setting the NCPAP Parameters

For NCPAP+Apnea function the transducer interface and the abdominal respiratory
sensor must be connected.

From the Mode Select Screen touch the NCPAP + Apnea
The screen changes to the Parameter Set Up Screen and shows:

• the patient respiration rate (Rsp)

• the delay time for the alarm to come on Tapnea

• the Inspiratory time for a manual sigh

Use the

buttons to set the alarm delay time.

button.

Confirm the settings by touching the flashing
been accepted, the screen changes to the Locked Screen.

Touch the

• the display changes to the Parameter Adjust Screen

675-120 Revision C November 2004

button. When the settings have

button to unlock the key pad.

42 Infant Flow

Note

If a high priority alarm occurs, the key pad automatically unlocks.

To return to the Mode Selection Screen, touch the button.

Setting the BiPhasic Parameters

For BiPhasic+Apnea function the transducer interface and the abdominal respiratory
sensor must be connected.

®

SiPAP

From the Mode Select Screen touch the Biphasic
The screen changes to the Parameter Set Up Screen and shows:

• the NCPAP Pres high inspiration time (Ti)

• the NCPAP Pres high respiration rate (R)

• the Inspiration/Expiration ratio (I/E)

button.

Note

If a transducer interface is connected to the unit, is displayed and BiPhasic +
Apnea monitoring mode is enabled. In addition to the above parameters, the screen
shows:

• the detected breath bar graph

• the detected breath rate (Rsp)

• the delay time for the alarm to come on (Tapnea)

Push the individual buttons to select between the parameters Ti, Rate, and Tapnea.
Use the

buttons to set the parameter for Ti, Rate, and Tapnea.

Note

The I/E rate changes accordingly.

Confirm the BiPhasic settings by touching the flashing BiPhasic or BiPhasic + Apnea
button.

When the settings have been accepted, the screen changes to the locked screen
and treatment starts.

To adjust the parameters, touch the
The screen changes to the BiPhasic or BiPhasic + Apnea Adjust Screen.

675-120 Revision C November 2004

button.

Service Manual 43

Parameters Ti and Rate can now be adjusted.

Note

The I/E rate changes accordingly.

To return to the Mode Selection Screen, touch the button.

Note

The button is shown with a pink background if an alarm condition occurs. If this
occurs, the button cannot be operated until the alarm condition has been cleared or
silenced using the alarm button.

After two minutes if the Operator has not made any inputs, the screen changes to the
Locked Screen.

• the key pad is locked

• the display remains as shown for patient monitoring

Touch the button to unlock the keypad.

• the display returns to the BiPhasic or BiPhasic + Apnea Adjust Screen

Note

If a high priority alarm occurs, the keypad automatically unlocks.

Setting the Triggered BiPhasic Parameters

From the Mode Select Screen touch the BiPhasic Tr button.

Note

The transducer interface must be connected to enter this mode.

The screen changes to the Parameter Set Up Screen and shows:

• the patient’s respiration rate (Rsp)

• the NCPAP Pres high inspiration time (Ti)

• the NCPAP Pres high backup respiration rate (Rb)

• the delay time for the apnea alarm to come on (Tapnea)

Press each individual button to select between the parameters Ti, Rb and Tapnea.
Use the

675-120 Revision C November 2004

buttons to set the parameter for Ti, Rb and Tapnea.

44 Infant Flow

Confirm the BiPhasic Tr settings by touching the flashing BiPhasic Tr button.
When the settings have been accepted, the screen changes to the locked screen

and treatment starts.

®

SiPAP

To adjust the parameters, touch the
The screen changes to the BIPHASIC TR Adjust Screen.
Parameters Ti, Rb and Tapnea can now be adjusted.

To return to the Mode Selection Screen, touch the

button.

button.

Note

The button is blank if an alarm condition occurs. If this occurs, the button
cannot be operated until the alarm condition has been cleared or silenced using the
alarm button.

After two minutes if the Operator has not made any inputs, the screen changes to the
Locked Screen.

• the key pad is locked

• the display remains as shown for patient monitoring

Touch the

• the display returns to the BiPhasic Tr Adjust Screen

button to unlock the key pad.

Note

If a high priority alarm occurs, the key pad automatically unlocks.

Calibration

WARNING

Calibration must only be done when the unit is not connected to the patient.

From the Start Up Screen touch the button.
The screen changes to the Calibration Screen.

• the alarm limits are disabled

Turn the FiO
Turn the FiO

control to 21 and confirm by touching the flashing button.

2

control to 100 and confirm by touching the flashing button.

2

675-120 Revision C November 2004

Service Manual 45

Touch the button.

The screen returns to the Start Up Screen .

Note

If the calibration procedure fails, a red is shown in the applicable button. Re­calibrate and if necessary, replace the O

fuel cell.

2

Giving a Manual Timed Sigh

In th e Mode Se l ect or Ad just screens of NCPAP+Apnea, BiPhasic+Apnea or BiPhasic
Tr - touch the

button to give the patient a manual timed sigh.

Operation Without Electrical Power

The IFSD can be used without mains or battery power. To use the IFSD in this
mode, set the required NCPAP flow on the NCPAP Pres low flowmeter and the
required FiO
except for the gas failure alarm/bypass which will operate until pressures are balanced.

level. All audible and visual indications and warnings are not given

2

Fault Indications

Refer to Table 1 (all models) and Table 2 (BiPhasic and BiPhasic Tr models only) for

the fault indications for specific faults and the procedures for resetting or canceling.

Discharged Battery

When the battery voltage is too low to power the circuits, the screen changes to the
Power Down Screen.

• all functions and controllable inputs are disabled

• the controller waits for the power source to be connected

• when external power is restored, the screen changes to the Power Up Screen

• the screen goes blank when the battery power is too low to power the Power

Down Screen

Fault Lockout

If a fault occurs which is detectable by the software and prevents the unit from
operating correctly, the screen changes to the Fault Lockout Screen.

• all functions and controllable inputs are disabled but the unit can still be used

without electrical power

• the related fault code numbers are shown on the screen

675-120 Revision C November 2004

46 Infant Flow

• the alarm bar comes on and the predominant fault code number is shown in
the status bar

If an error code is shown, refer to the Service Manual or contact your Service
Engineer to rectify the faults.

Over Pressure Indications

If an over pressure occurs, the software opens the dump valve to release the
pressure.

• the upper pressure limit is shown in red

• the pressure display flashes

• when the pressure drops below the lower limit, the lower limit is shown in red

and the pressure flashes alternately between the limits

Rectify the fau lt by adjustment of the hi gh pressure and touch the warning button for
three seconds to reset.

Table 5 - Faults and Indications

®

SiPAP

Alarm Method of Setting

Minimum oxygen
concentration
(<

18 FiO2).

Over pressure
(Patient pressure
> 11 cmH
NCPAP mode).

O when in

2

Always active when
power is on.

Always active when
power is on.

Indications and
Actions

Intermittent high level
Audible Alarm.

Warning Bar flashes.
FiO

display flashes.

2

Digital O
limit is highlighted.

Alarm Button flashes.

Intermittent high level
Audible Alarm.

Warning Bar flashes.
Pressure display

flashes.
Digital high-pressure

alarm limit is
highlighted.

Alarm Button flashes.
Dump valve actuated

for three seconds to
stop flow to patient and
repeated until flow
returns to normal.

alarm low

2

Method of Resetting
or Canceling

Restore FiO
above the low limit
then push Alarm
Button for three
seconds.

Reduce pressure to
below the high
pressure limit then
push the Alarm
Button for three
seconds.

level to

2

675-120 Revision C November 2004

Service Manual 47

Alarm Method of Setting

High oxygen concentration
(>

5 FiO2 above set point
at time alarm is set for 15
seconds,
or
>

104 FiO2 for > 15

seconds).

Low oxygen concentration
(< 5 FiO

below set point

2

at time alarm is set for 15
seconds,
or
<

20 FiO2 for > 15

seconds).

Set automatically on
entering NCPAP
mode for the first time
after start up or by
pushing the Alarm
Button for three
seconds at any time.

Set automatically on
entering NCPAP
mode for the first time
after start up or by
pushing the alarm
button for three
seconds at any time.

Indications and
Actions

Intermittent high level
Audible Alarm.
Warning Bar flashes.
O

digital display

2

flashes.
Digital O

alarm high

2

limit is highlighted.
Alarm Button flashes.

Intermittent high level
Audible Alarm.

Warning Bar flashes.

digital display

O

2

flashes.
Digital O

alarm low

2

limit is highlighted.
Alarm Button flashes.

Method of Resetting
or Canceling

Push the Alarm
Button once to stop
the Audible Alarm for
30 seconds (Alarm
Button flashes, digital
O

alarm high limit

2

stays highlighted,
Warning Bar still
flashes).

Push the Alarm
Button for three
seconds to reset the
limit (alarms clear).

Push the Alarm
Button once to stop
the Audible Alarm for
30 seconds (Alarm
Button flashes, digital

alarm low limit

O

2

stays highlighted,
Warning Bar still
flashes).

Push the Alarm
Button for three
seconds to reset the
limit (alarms clear).

High NCPAP pressure (>
3 cmH

O above set point

2

at time alarm is set for 15
seconds).

Set automatically on
entering NCPAP
mode for the first time
after start up or by
pushing the alarm
button for three
seconds at any time.

Intermittent high level
Audible Alarm.

Warning Bar flashes.
Pressure display

flashes.
Digital pressure high

limit is highlighted.
Alarm Button flashes.

Push the Alarm
Button once to stop
the audible alarm for
30 seconds (Alarm
Button flashes, digital
pressure high limit
stays highlighted,
Warning Bar still
flashes). Push the
Alarm Button for
three seconds to
reset the limit (alarms
clear).

675-120 Revision C November 2004

48 Infant Flow

®

SiPAP

Alarm Method of Setting

Low pressure
(<

2 cmH2O below set
point for 15 seconds)
or
<

1 cmH2O at any time).

Set automatically on
entering NCPAP
mode for the first time
after start up or by
pushing the alarm
button for three
seconds at any time.

Over pressure (Patient
pressure
> 11 cmH

O when in

2

Always active when
power is on.

BiPhasic or BiPhasic Tr
mode).

Indications and
Actions

Intermittent high level
Audible Alarm.

Warning Bar flashes.
Pressure display

flashes.
Digital pressure low

limit is highlighted.
Alarm Button flashes.

Intermittent high level
Audible Alarm.

Warning Bar flashes.
O

digital display

2

flashes.
Digital O

alarm low

2

limit is highlighted.
Alarm Button flashes.

Method of Resetting
or Canceling

Push the Alarm
Button once to stop
the Audible Alarm for
30 seconds (Alarm
Button flashes, digital
pressure low limit
stays highlighted,
Warning Bar still
flashes ).

Push the Alarm
Button for three
seconds to reset the
limit (alarms clear).

Reduce pressure to
below the high
pressure limit then
push the Alarm
Button for three
seconds.

High BiPhasic/ BiPhasic
Tr pressure
(MAP >

3 cmH2O above
set point at time alarm is
set for 15 seconds).

Low battery charge
(<

40%).

Set automatically on
entering NCPAP
mode for the first time
after start up or by
pushing the alarm
button for three
seconds at any time.

Intermittent high level
Audible Alarm.

Warning Bar flashes.
High MAP pressure

display flashes.
Digital high MAP

pressure limit is
highlighted.

Alarm Button flashes.

Automatic Battery status indicator

changes from gray to
red.

Push the Alarm
Button once to stop
the Audible Alarm for
30 seconds (Alarm
Button flashes, digital
high MAP pressure
limit stays
highlighted, Warning
Bar still flashes).

Push the Alarm
Button for three
seconds to reset the
limit (alarms clear).

Connect external
power.

675-120 Revision C November 2004

Service Manual 49

Alarm Method of Setting

Low battery voltage
(<

10 V for 5 seconds).

Automatically
constantly monitored
with the power switch
in the on position with
no external power
connected.

Battery fault

Automatic Intermittent high level
(Battery disconnected or
failing to take or hold
charge).

Indications and
Actions

Intermittent medium
level Audible Alarm.

Warning Bar flashes
intermittently.

Battery status indicator
flashes.

Unit starts a controlled
shut down at a set limit.

Audible Alarm.
Warning Bar flashes

intermittently.
Battery status indicator

flashes.
Screen displays

flashing fault code (E
number)

Method of Resetting
or Canceling

Push the Alarm
Button once to stop
the Audible Alarm for
three minutes (Alarm
Button flashes,
battery status
indicator stays
flashing).

Connect external
power (alarms clear).

Visual alarms remain
until battery charge
state is above low

Cannot be reset.
Push the Alarm
Button once to stop
the Audible Alarm for
60 seconds.

Refer to Service
Engineer.

External power
disconnected.

Automatic Intermittent high level

Audible Alarm.
Warning Bar flashes

intermittently.
Battery status indicator

and power indicator
alternately flash.

Software fault Automatic Intermittent high level

Audible Alarm.
Warning Bar flashes

intermittently.
Screen displays

flashing fault code (E
number).

Push the Alarm
Button once to stop
the audible alarm.
(The Warning Bar
stops flashing and
the battery status
indicator is
displayed.)

Reconnect the
external power.

Cannot be reset.
Refer to Service

Engineer.

675-120 Revision C November 2004

50 Infant Flow

)

®

SiPAP

Alarm Method of Setting

Software not running with
unit connected to power

Blender whistle Water trap blocked,

Oxygen cell calibration
error.

Flowmeter fault. Flowmeter fault No flow indications or

Automatic Constant Audible

full or leaking; filters
blocked; loss of wall
pressure; imbalance
of wall gas supply.

Automatic monitoring
(oxygen cell
incorrectly calibrated,
damaged or depleted).

Indications and
Actions

Alarm.
Warning Bar on.
Screen displays

flashing fault code (E
number

Audible Alarm. Refer to Service

Difference between
displayed and set
value.

flow cannot be
adjusted.

.

Method of Resetting
or Canceling

Cannot be reset.
Refer to Service

Engineer.

Engineer.

Calibrate or replace
oxygen cell. Refer to
Service Manual.

Refer to Service
Engineer.

Electrical fault. Electrical fault External power light

does not match screen
icon.

Refer to Service
Engineer.

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Service Manual 51

Alarm Method of Setting

Low breath rate
(Rr = 0 for >

breath rate
timeout as determined by
patient trigger module).

Set automatically on
entering BiPhasic Tr,
NCPAP + Apnea or
BiPhasic +Apnea
modes if patient
trigger is installed and
selected.

Indications and
Actions

Intermittent high level
Audible Alarm.

Warning Bar flashes.
Breath rate digital

display flashes.
Breath rate icon

flashes.
In BiPhasic models

with monitored NCPAP
+ Apnea, a single sigh
is given.

In BiPhasic Tr Mode
backup sighs at the set
rate are given.

Alarm Button flashes.
The timer is reset and

the applicable sigh
function is repeated
until breathing
restoration is detected
or the Operator
intervenes.

Method of Resetting
or Canceling

Push the Alarm
Button once to stop
the Audible Alarm for
30 seconds (Alarm
Button flashes,
breath rate icon and
digital display still
flashes, Warning Bar
still flashes, in
BiPhasic Tr Mode
backup sighs at the
set rate continue).

Restore patient
breathing.

If breath detection is
restored before the
next breath rate
timeout period has
elapsed, the alarm
condition is
automatically
cleared.

BiPhasic/BiPhasic Tr
mode fails to operate as
set.

Automatic monitoring Intermittent high level

Audible Alarm.
Warning Bar flashes

intermittently.
NCPAP Pres high on

time display flashes.
Screen displays

flashing fault code (E
number).

Cannot be silenced
Revert to NCPAP
mode or refer to
Service Engineer.

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52 Infant Flow

Diagnostics

Diagnostic mode is accessed by enabling DIP switch 6 and exited by disabling it.
Enable DIP switch 6 during Start Up, Adjust or Mode Selection.
The screen changes to the Diagnostics Menu Screen (for a description of the

displayed information refer to paragraph 1.2.5):

• the alarm limits are disabled

• low level calibration procedure for pressure, oxygen and flow sensors are

available via the key pad

• test procedures for valves and user interface are available via the key pad

• the error log is accessible via the key pad

Select to carry out a pressure calibration
The diagnostic main screen stays the same and the key pad layout changes. Touch

the first key to calibrate at 0 cm H2O followed by the second key to calibrate at 10
cm H2O.

®

SiPAP

To return to the Diagnostics Menu Screen, touch the

button.

Select

to carry out an oxygen calibration

The diagnostic main screen stays the same and the key pad layout changes. Touch
the first key to calibrate at 21 % O
O

.

2

To return to the Diagnostics Menu Screen, touch the

followed by the second key to calibrate at 100 %

2

button.

Select

to enter a security code.

In order to upgrade features on the unit, a security code must be obtained from
VIASYS Technical Support (see fig 5a). After the code is entered, the customer’s
unit can be upgraded to different feature sets as laid out by Marketing.

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Service Manual 53

Figure 11 – Security Screen

To return to the Diagnostics Menu Screen, touch the button.

Select

to carry out a valve test

The diagnostic main screen stays the same and the key pad layout changes. Touch
the first key to test the zero valve, the second key to test the dump valve and the third
key to test the PA valve.

To return to the Diagnostics Menu Screen, touch the
Select

to carry out a user interface test

button.

The diagnostic main screen stays the same and the key pad layout changes. Touch
the first key to test the battery, the second key to test the audible alarm and the third
to test the respiratory indicator.

To return to the Diagnostics Menu Screen, touch the
Touch the

button to show the Error Log Screen

button.

The screen changes to the Error Log Screen and shows a list of error code numbers.
The error code is:

• shown normal if it has occurred since the last reset

• shown grayed if it is inactive since the last reset

• flashing if the error is active since power up or last cleared

To mute flashing errors, the
Refer to Table 6 for the details of error codes and corrective action.

When the corrective action has been taken, to clear all faults the

675-120 Revision C November 2004

button.

button.

54 Infant Flow

Table 6 - Error Codes

®

SiPAP

Error
Code

- Program memory

Fault Condition Consequence

Unusable – Software

checksum error.

corrupt, execution
inhibited.

- Battery too discharged
(<6.5 V) to operate LCD,

Unusable - no user

interface display.
analogue and valve driver
circuits (no external
power).

- Battery too discharged
(<10 V) to operate

Unusable – sensor

readings invalid.
analogue and valve driver
circuits but sufficient for
LCD driver (no external
power).

E10 Non-volatile memory fault. Unusable - unable to

retrieve/set unit

configuration and

calibration data.

Software
Response

Hardware held in
permanent reset
condition with
Warning Bar on.

Hardware held in
reset condition
with Warning Bar
(status LED off)
on until external
power applied.

User lockout
‘Plug in external
power’ prompt

User lockout
‘Error number’
prompt.

Corrective
Action

Reload
software.

Plug in
external
power.

Plug in
external
power.

Replace main
control PCB.

E11 Calibration data lost. Unusable – sensor

readings invalid.

E12 Configuration DIP settings

and/or PT PRESENT
different to non-volatile

Unusable – possible

incomplete unit set up

performed.
configuration record.

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

Put the unit
into
diagnostics
mode (DIP6
ON) and re­calibrate O

2

and pressure
sensors.

Ensure that all
the DIP switch
settings are
correct and
the patient
trigger
board/cable
are correctly
attached (if
required). Put
the unit into
diagnostics
mode, clear
the E12 error,
then return to
normal mode.

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Service Manual 55

Error
Code

Fault Condition Consequence

E20 Charged battery voltage

too low (<11 V) when
under test load.

E21 External supply voltage too

low (<14 V) to charge
battery (battery flat).

E22 Analog supply rails out of

limits.

E23 Valve driver supply rails

out of limits.

No backup – battery
capacity low.

No backup – battery will
not charge.

Unusable - unreliable
sensor readings.

Unusable - unreliable
valve operations.

Software
Response

Battery fault icon
flashes and ‘Error
number’ alarm
prompt.

Battery low alarm
continues even
when external
power applied.
‘Error number’
alarm prompt.

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

Corrective
Action

Replace
battery or
charger.

Replace the
PSU module.

Replace the
main control
PCB and
re-calibrate O
and pressure
sensors.

Replace the
main control
PCB and re­calibrate O

2

and pressure
sensors.

2

E24 Hardware safe-start

watchdog disabled.

E30 Pressure sensor fault

(ADC hits rail).

E31 Zero valve not connected

(via sense).

Unusable – valve
disabled.

Unusable – pressure
sensor readings invalid.

Unusable – pressure
sensor readings
unreliable.

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

Power cycle
unit. If fault
still occurs,
replace the
main control
PCB and
re-calibrate O
and pressure
sensors.

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

2

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56 Infant Flow

®

SiPAP

Error
Code

Fault Condition Consequence

E32 Zero valve activation fault

(via sense).

E33 Unable to auto zero

pressure sensor.

E41 Dump valve not connected

(via sense).

E42 Dump valve activation fault

(via sense).

Unusable – pressure
sensor readings
unreliable.

Unusable – pressure
sensor readings
unreliable.

Restricted - no over
pressure protection.

Restricted - no over
pressure protection.

Software
Response

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

Restricted mode
‘Error number’
alarm prompt.

Restricted mode
‘Error number’
alarm prompt.

Corrective
Action

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

E50 Oxygen sensor fault (ADC

hits rail).

E51 Oxygen sensor cannot be

calibrated by user (bad
offset or high gain).

Unusable – oxygen
sensor readings invalid.

Unusable – possible
fuel cell, electronic,
blender or gas supply
fault.

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

Replace the
pneumatics
PCB and re­calibrate O

2

and pressure
sensors.

Check the
Error Log
screen in
diagnostics
mode. If an
E52 error also
occurs, replace
the fuel cell
and re­calibrate the
O

sensor-

2

otherwise
check the
blender and
gas supplies.

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Service Manual 57

Error
Code

Fault Condition Consequence

E52 Oxygen sensor calibrates

but the fuel cell is worn out
(low gain).

E53 Oxygen sensor too noisy

to calibrate (calibration
timeout).

Oxygen calibration suspect

E54

(oxygen value has been
measured as outside range
18 – 104%)

E61 NCPAP Pres high valve

not connected (via sense).

Unusable – oxygen
sensor readings
unreliable.

Unusable – oxygen
sensor readings
unreliable.

Oxygen sensor
readings unreliable

Restricted -
BiPhasic/BiPhasic
unusable.

Software
Response

User lockout
‘Error number’
prompt.

User lockout
‘Error number’
prompt.

“E##” alarm, non­mutable, pending
oxygen re­calibration

Restricted mode.
‘Error number’
alarm prompt.

Corrective
Action

Replace the
O

fuel cell

2

and re­calibrate the
O

sensor.

2

Replace the
O

fuel cell

2

and re­calibrate the
O

sensor.

2

Recalibrate O
sensor. If this
fails replace
the O

cell

2

and re­calibrate.

Replace the
pneumatics
PCB and re­calibrate the
O

and

2

pressure
sensor.

2

E62 NCPAP Pres high valve

activation fault (via sense).

E70 PT module fault (PTRDY

or CAN bus failure).

E71 No breath signal from PT

module although CAN
data does not report
Apnea.

E72 No trigger signal from PT

module in BiPhasic Tr
mode.

Restricted ­BiPhasic/BiPhasic Tr
unusable.

Untriggerable - Apnea
and PT unusable.

Untriggerable - Patient
may be in Apnea but
PT module may be
dysfunctional.

Untriggerable – No
BiPhasic Tr treatment
given to patient.

Restricted mode.
‘Error number’
alarm prompt.

Reduced
functionality
‘Error number’
alarm prompt.

Reduced
functionality
‘Error number’
alarm prompt.

Reduced
functionality
‘Error number’
alarm prompt.

Replace the
pneumatics
PCB and re­calibrate the
O

and

2

pressure
sensor.

Check the
Patient
Trigger
interface
module/cables
are correctly
connected.

Replace the
Patient
Trigger
board/cable.

Replace the
Patient
Trigger
board/cable.

675-120 Revision C November 2004

58 Infant Flow

®

SiPAP

Error
Code

Fault Condition Consequence

E90* Spurious software

interrupt, XTAL fails, stack
overflow/ underflow, CPU
Class B exception.

E90 Abnormal hardware,

software or watchdog
reset.

E91 Internal software error

detected.

Spurious – software
interrupted and restarts
(possibly during
treatment).

Spurious – software
restarts possibly during
treatment.

Unusable – software
unreliable.

Software
Response

Hardware
reinitialized
(disabled) with
alarm bar on and
audible alarm
sounding to
identify root
cause.

Software restarts
‘Error number’
alarm prompt.

User lockout
‘Error number’
prompt.

Corrective
Action

Replace the
main control
PCB and re­calibrate O

2

and pressure
sensors.

Replace the
main control
PCB and
re-calibrate O
and pressure
sensors.

Replace the
main control
PCB and
re-calibrate O
and pressure
sensors.

2

2

E99 Unknown error detected. Unusable – software

unreliable.

* - Generated as a consequence of the fault.

User lockout
‘Error number’
prompt.

Replace the
main control
PCB and
re-calibrate O
and pressure
sensors.

2

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Service Manual 59

675-120 Revision C November 2004

Service Manual 60

Chapter 7- Maintenance

Cleaning

CAUTION

Do not immerse any part of the IFSD in water or sterilize it with gas or steam.

1 Clean the exterior surfaces of the IFSD and the transducer interface with a mild

soap or liquid disinfectant solution. Do not use cleaning agents that contain
abrasives.

2 Make sure that cleaning agents do not enter the unit through patient

connection ports.

Maintenance

WARNING

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.

General

1 Examine the exterior of the case for damage and dirt. If necessary clean the

2 Check the water trap on the back panel. If water is visible in the water trap,

3 Technical Assistance can be obtained from the offices listed at the beginning

4 Store the unit in a clean dry location. Make sure that the connections and ports

5 Dispose of scrap units in accordance with the local regulations

Removal and Fitting of Parts – General

1 Only parts approved by VIASYS Healthcare may be used in this unit.
2 Remove all attached patient connections before removal of parts. Disconnect

3 Place the unit on a stable, clean work surface before removal of parts.

unit.

push the button on the bottom of the water trap to release the water.

of this manual.

are suitably blanked to prevent the ingress of dirt, moistur e and for eign ob jects. If
the unit is not being used for a long period of time, remove the battery.

the unit from the power supply.

675-120 Revision C November 2004

Service Manual 61

4 Numbers in parenthesis in the Removal/Fitting procedures are the item

numbers on the associated figure.

5 Lubricate new O-rings before installation with grease, Krytox 240AC before

installation.

Maintenance Frequencies

Table 7 shows the recommended frequencies for replacement of components.

Table 7 - Maintenance Frequencies

Component Replacement Frequency

Battery Annually

Oxygen Filter Annually

Fuel Cell Filter/Restrictor Annually

Fuel Cell Annually

Blender (Check Valves and Filter) Annually

Water Trap Filter Annually

Pilot Drive Check Valves Annually

Case Bleed Filtered Restrictor Annually

Blender Alarm and Bypass
Components (by replacement of
blender or Blender Overhaul Kit

Solenoid Valve (by replacement of
Valve/Sensor PCB)

Every Two Years

Every Five Years

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62 Infant Flow

Removal and Fitting of Case

Refer to Figure 12.

Removal

1 Remove the ten screws (1) on the rear panel.
2 Pull off the case (2).

Fitting

1 Install the case (2) over the main frame, making sure that all wires and pipes

are secure and cannot be trapped by the case.
2 Install the ten screws (1) on the rear panel and tighten.
3 Carry out an Oxygen Leak check (see Appendix A) and functional check of the

IFSD.

Note: An Oxygen Leak test must be done after every service that requires removal of
the case to ensure no buildup of oxygen is present within the case.

®

SiPAP

Removal and Fitting of Battery

Refer to Figure 13.

Removal

1 Remove the case.

675-120 Revision C November 2004

Figure 12 - Case Removal/Fitting

Service Manual 63

2 Disconnect the battery lead connector SK3 (1) (cable 5) from the plug PL3 on

the Main Processor PCB. Remove the screw (2) on the rear panel and remove
the s p acer (3) c o m p l e te with compression pad.

3 Pull the battery (4) complete with lead from the compartment.

Note

The battery is held in position in the compartment by up stands (5) on the frame.

4 Feed the battery lead through the frame, pull the grommet (6) from the

recessed hole in the frame and remove the battery.

Fitting

1 Feed the battery lead through the frame to plug PL3 on the Main Processor

PCB.

2 Slide the battery into the compartment between the two upstands (5) and

position the grommet (6) in the recessed hole in the frame.

3 Install the spacer (3) the correct way round so that the compression pad is

located in the center of the battery and secure in position with the screw (2).
Tighten the screw (2).

4 Connect the battery lead connector SK3 (1) to the plug PL3 on the Main

Processor PCB.
5 Refit the case.
6 Carry out an Oxygen Leak check (See Appendix A)and functional check of the

IFSD.

675-120 Revision C November 2004

64 Infant Flow

Figure 13 - Battery Removal/Fitting

®

SiPAP

675-120 Revision C November 2004

Service Manual 65

Removal and Fitting of Oxygen Filter

Note

This procedure can be done without removing the case.

Refer to Figure 14.

Removal

1 Remove the banjo screw (1) on the end of the air/oxygen mounting block (2).
2 Remove the filter (3).
3 Remove and discard the O-ring (4).

Fitting

1 Install a new O-ring (4) on the banjo screw (1).
2 Install a new filter (3) in the air/oxygen mounting block and install the banjo

screw (1).
3 Tighten the banjo screw (1).

675-120 Revision C November 2004

Figure 14 - Oxygen Filter Removal/Fitting

66 Infant Flow

Removal and Fitting of Fuel Cell Filter/Restrictor

Refer to Figure 15.

Removal

1 Remove the case .
2 Remove the oxygen filter screw (1) from the flow mixer block (2). Remove th e

filter/restrictor (3). Remove and discard the O-ring (4) and the O-ring (5) from
the oxygen filter screw (1).

Fitting

1 Install a new O-ring (5) on the oxygen filter screw (1). Install a new O-ring (4)

and the filter/ restrictor (3) into the flow mixer block (2). Install the oxygen filter

screw (1) and tighten.
2 Refit the Case.
3 Carry out an Oxygen Leak check (see Appendix A)and functional check of the

IFSD and calibrate the fuel cell.

®

SiPAP

Figure 15 - Oxygen Filter Restrictor Removal/Fitting

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Service Manual 67

Removal and Fitting of the Fuel Cell

Refer to Figure 16.

Removal

1 Remove the case.
2 Disconnect the connector SK12 (1) from the top of the fuel cell.
3 If necessary, remove the screw (2) securing the C clip (3) and release the C

clip securing the cable (cable 7) and the ferrite.

4 Unscrew the fuel cell (4) from the flow mixer block (5).

Note

The fuel cell is installed finger tight, but it may be necessary to use a suitable wrench
on the flats at the top of the fuel cell to remove it. The leak compensation pipe (6)
can also be disconnected from the elbow to gain access.

5 Discard the fuel cell (4) and attached O-ring.

Fitting

1 Check the expiration date of the new fuel cell. Remove the fuel cell from the

sealed package and check that the fuel cell has an O-ring installed above the

threads.
2 Screw the fuel cell (4) into the flow mixer block (5) and tighten finger tight.
3 If removed, secure the cable (cable 7) and the ferrite with C clip (3) and the

screw (2).
4 5 Connect the connector SK12 (1) to the fuel cell.
5 Refit the case.
6 Carry out an Oxygen Leak check (see Appendix A)and functional check of the

IFSD and calibrate the fuel cell.

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68 Infant Flow

Figure 16 - Fuel Cell Removal/Fitting

®

SiPAP

Removal and Fitting of Blender and Components

Refer to Figure 17.

Removal

1 Remove the case.
2 Remove the battery.
3 Disconnect the connector SK1 (1) on the LED PCB.
4 Disconnect the connector SK5 (2) on the Main Processor PCB.
5 Disconnect the connector at PL5 (3) on the Patient Trigger PCB.

1

6 Remove the input connection tube (4) by pulling the elbow off the

tube, taking care not to break the barbs on the elbow.

7 Remove the cover (6) from the front of the FiO

control knob (7) and the two

2

covers (8) from the front of the NCPAP Pres low and NCPAP Pres high flow
control knobs (9) by gently prying out of the recess in the knob with a small
screwdriver.

8 Using a screwdriver or Circle pliers, unscrew the central securing nuts for the

flowmeter knobs and pull off the control knobs (9).

9 Using the Special wrench, unscrew the collet on the front of the FiO

knob (7), remove the collet and pull off the control knob (7).
10 Remove the eight screws (10) from the front panel (11).
11 Pull the front panel assembly (11) off the frame, taking care not to damage any

tubes.
12 Remove and discard the O-ring (12).

/8 “ silicone

control

2

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Service Manual 69

13 Remove the Valve/Sensor PCB (13) as follows:

a Disconnect the fuel cell connector SK1 (14) at PL1 on the Valve/Sensor

PCB.

b Disconnect the dump/vent valve connector SK3 (15) at PL3 on the

Valve/Sensor PCB.
c Remove the five screws (16).
d Pull the Valve/Sensor PCB (13) downwards and out forward to

disconnect the PCB from the D plug PL2.
e Disconnect the exhaust tubes and the PA flow tube and remove the

Valve/Sensor PCB.

14 At the blender, disconnect the air supply (17), the oxygen supply (18), the

whistle outlet tube (19) and the main outlet (20).

15 Remove the four screws (21) securing the blender (22) and remove the

blender. Do not remove the collet knob on the front of the blender.

16 Remove the pilot drive check valves as follows:

a Disconnect the cylinder body (23) from the tee piece (24) and elbow

(29).
b Hold the nut (25) and unscrew the cylinder body (23).
c Remove the duckbill check valves (26), guide (27) and seat (28).
d Discard the duckbill check valves (26).

17 Replace the blender check valves and filter at the blender inlet (refer to the

Blender Service Manual if installing the Blender Overhaul Kit).

18 Replace the blender alarm bypass components (refer to the Blender Service

Manual if installing the Blender Overhaul Kit).

675-120 Revision C November 2004

70 Infant Flow

®

SiPAP

Figure 17 - Blender and Components Removal/Fitting

Fitting

1 Fit new pilot drive check valves as follows:

a Fit the seat (28), a duckbill check valve (26), the guide (27), the second

duck bill check valve into the cylinder (23).
b Hold the nut (25) and tighten the cylinder body (23).
c Connect the cylinder bodies (23) to the tee pieces (24) and connect the

elbows (29).

2 Fit the blender or refurbished blender (22) with the four screws (21) into the

front frame panel.

3 Connect the air supply (17), the oxygen supply (18), the whistle outlet tube (19)

and the main outlet (20).

4 Fit the Valve/Sensor PCB (13) as follows:

a Connect the exhaust tubes and the PA flow tube.

675-120 Revision C November 2004

Service Manual 71

b Fit the Valve/Sensor PCB (13) to the D plug PL2.
c Fit the five screws (16).
d Connect the fuel cell connector SK1 (14) at PL1 on the Valve/Sensor

PCB.

e Connect the dump/vent valve connector SK3 (15) at PL3 on the

Valve/Sensor PCB.
5 Fit a new O-ring (12) to the front panel assembly.
6 Fit the front panel assembly (11) and install the eight screws (10).
7 Set the FiO

collet on the blender to the 21 % position. Align the control knob

2

(7) so that the pointer is in the 21 % position and install the control knob. Secure
the control knob with the nut and tighten. Install the cover (6).

8 Install the NCPAP Pres low and NCPAP Pres high flow control knobs (9) on

the spindles. Using a screwdriver or Circle pliers tighten the central securing
nuts. Install the covers (8).

9 Install the input connection tube (4) on the elbow of the

1

/8 “ silicone tube.
10 Connect the connector at PL5 (3) on the Patient Trigger PCB.
11 Connect the connector SK5 (2) on the Main Processor PCB.
12 Connect the connector SK1 (1) on the LED PCB.
13 Install the battery.
14 Carry out an Oxygen Leak check (see Appendix A )and functional check of the

IFSD and calibrate the fuel cell.

15 Install the case.

Removal and Fitting of Water Trap Filter

Refer to Figure 18.

Removal

1 Remove the case.
2 Remove the filter bowl (1) with the Special Spanner.
3 Pull out and discard the filter (2) from the water trap.

Fitting

1 Install the new filter (2) in the water trap.
2 Screw on the water trap bowl (1) and tighten using the Special Spanner.
3 Install the case.

675-120 Revision C November 2004

72 Infant Flow

Removal and Fitting of Case Bleed Filtered
Restrictor

Refer to Figure 18.

Removal

1 Remove the case.
2 Remove the case bleed filtered restrictor (3) from the pipe.
3 Discard the case bleed filtered restrictor (3).

Fitting

1 Install the new case bleed filtered restrictor (3).
2 Screw on the water trap bowl (1) and tighten using the Special Spanner.
3 Install the case.

®

SiPAP

675-120 Revision C November 2004

Figure 18 Water Trap Filter Removal/Fitting

Service Manual 73

Removal and Fitting of PA Solenoid Valve

The PA Solenoid Valve is replaced by replacing the Valve/Sensor PCB

Removal

1 Remove the case.
2 Remove the Valve/Sensor PCB.

Fitting

1 Install the new Valve/Sensor PCB.
2 Carry out an Oxygen Leak check (see Appendix A)and functional check of the

IFSD and calibrate the fuel cell.

Firmware Reload/Upgrade

The firmware reload/upgrade uses a Software Download Utility (P/N 675-821) and a
download cable (P/N 675-819). Please contact Technical Support for Security
Password. To reload/upgrade the firmware:

1 Remove the case from the IFSD.
2 Connect the Download Cable to the COM port on the PC (running Windows 95

or later) and to the pin strip plug PL4 on the Main Processor PCB. Cable should

only be connected/disconnected with unit turned OFF.
3 Switch on the PC and insert the CD into the disk drive on the PC.
4 Run the download program (Downloader.exe).
5 Select the Serial Port and Baud rate as appropriate.

Note

Auto baud rate may fail for 115200 bps on some PC’s. If this happens, manually
select 57600 bps.

6 If necessary, edit the path and file name of the hardware BSL file name and

Firmware file name. Make sure that the BSL file name matches.
7 Enter the serial number for the target unit (in the range 1 to 65535).
8 Switch on the IFSD. Switch to Diagnostics Mode.

Note

The audible alarm sounds continuously.

9 Click on the Check File button and check that the firmware file checksum and

image checksum are the same.

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74 Infant Flow

10 Click on the Download button. The download takes approximately 1 minute at

57600 bps. When th e do w n l o a d i s c o m p le t e , t h e a u d i b l e a l a r m o n t h e I FS D s t o p s

and t h e unit ent e rs the normal operational mode.
11 Disconnect the Download Cable from plug PL4 on the Main Processor PCB.
12 Refit the case.
13 Carry out a functional check of the IFSD.

Testing

Leak Check

WARNING

Ensure the whistle sounds during gas connection, if not the device may be
faulty and should not be used.

1 With the case removed, connect the Medical Air and Oxygen hoses to the IFSD

connections on the back panel and set both gas supply pressures to 4 bar.

Set FiO

to 60% and NCPAP Pres low flowmeter to >= 3lpm.

2

®

SiPAP

Note

The gas failure alarm/bypass warning whistle sounds until the pressures balance.

2 Listen for signs of leaks at pipe connections. Make sure there are no leaks

from any valves and connections. Rectify any leaks by replacing tubing as

required.
3 Refit the case after leak checking. Functional Check
4 Connect the IFSD to the air and gas supplies and the power cable to a suitable

power supply outlet. Connect the patient outlets.
5 Carry out a functional check of NCPAP, BiPhasic and BiPhasic Tr . Calibration
6 Calibrate the unit at 21 % and 100% using the calibration screen or the

diagnostic screen.

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Service Manual 75

Chapter 8 – Explanation of Symbols

The following symbols may be referenced on the Infant Flow® SiPAP driver or in
accompanying documentation

Symbol Source / Compliance Meaning

Symbol #03-02 IEC 60878
Symbol #5016 IEC 60417 This symbol indicates a FUSE.
VIASYS Healthcare Symbol

2.5A/T 250 V
101010

Symbol #5031 IEC 60417 This symbol indicates DIRECT CURRENT (DC)

Symbol #5032 IEC 60417
Symbol #01-14 IEC 30878

Symbol #5019 IEC 60417
Symbol #01-20 IEC 60878

Symbol #5021 IEC 60417
Symbol # 01-24 IEC 60878

Symbol #5007 IEC 60417
Symbol #01-01 IEC 60878

Symbol #5008 IEC 60417
Symbol #01-02 IEC 60878

Indicates ATTENTION, consult ACCOMPANYING
DOCUMENTS

This symbol indicates an INTERNAL BATTERY
FUSE

Fuse holder and fuse rating

Electrical AC inlet

The equipment is suitable for alternating current.

This symbol indicates protective EARTH (ground).
This symbol indicates the EQUIPOTENTIAL

connection used to connect various parts of the
equipment or of a system to the same potential, not
necessarily being the earth (ground) potential (e.g.,
for local bonding).

Power ON

Power OFF

Power ON (for part of the equipment)

MDD Directive 93/42/EEC CE Mark

675-120 Revision C November 2004

Power OFF (for part of the eq uipme nt)

ETL Mark and Registration Number

76 Infant Flow

Symbol Source / Compliance Meaning

®

SiPAP

VIASYS Healthcare Symbol

VIASYS Healthcare Symbol Respiratory Connection and Indicator

Symbol # 5333 IEC 60417
Symbol #02-03 IEC 60878

Operating temperature range of unit

Warning Bell

This symbol indicates TYPE B equipment, which
indicates equipment that provides a particular
degree of protection against electric shock,
particularly with regards to allowable leakage
current and reliability of the protective earth
connection.

Type BF patient applied part

Year of Manufacture
Unique Batch Number Identifier

Use Before Expiry Date shown
Year-Month

Single Use Only - Do NOT Re-use

Keep Dry

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Keep Away from Heat

RS232 Connection

Service Manual 77

Symbols used on buttons

The following symbols are used to label user input areas within the graphical display.
As needed displays in this table are shown separately as Domestic US configuration
displays (left-hand column) and International configuration displays (right-hand
column).

Symbol Description

High Priority Alarm Active

Medium Priority Alarm Active

Low Priority Alarm Active; medium and high priority
alarms are resolved. Alarm does not flash.

No alarms (active or resolved) are present

Active alarm silenced

Adjust BiPhasic rate

Adjust BiPhasic Tr backup rate

Adjust apnea alarm timeout

Adjust low breath rate alarm timeout

Adjust BiPhasic, BiPhasic Tr on time, and NCPAP
manual breath function

Decrease / Increase currently selected parameter

Go to mode select screen.

Nasal CPAP mode

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78 Infant Flow

Nasal CPAP mode with breath rate monitoring

BiPhasic mode

BiPhasic mode with breath rate monitoring

BiPhasic Tr mode with breath rate monitoring

Manual Breath. Single breath cycle at current settings
for Ti, NCPAP Pres high and O
delivered regardless of button press duration

Toggle between Main Screen and Monitored Parameter
Screen

Go to user calibration mode screen

%. One breath cycle is

2

®

SiPAP

Confirm

Wait

Completed

Action has failed

Press to un-lock keypad
Warning message. To clear, press any of the three

icons.

Note

Provision of labeling in this manual for any function should not be taken as evidence
that the function is available. For example parameter R
not currently approved for use in the US.

relates to BiPhasic Tr mode,

B

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Service Manual 79

Appendix A- Oxygen Leak Test

Oxygen Leak Test

This test will check for leaks within the enclosure.
Test equipment needed:

Calibrated oxygen analyzer

1. Connect the driver to the air and oxygen supplies. Use adaptors to couple to the
customer-specified gas block on the driver.

2. Connect the oxygen analyzer sampling tube to the driver by replacing the M6 Pan Screw
(Item 31, 675-002) with an M6 fitting. Before operating the driver, take an initial O2
concentration reading and record on TIR-004. Plug the fitting.

3. Switch the power on. The next step will setup the unit to operate in Bi-phasic mode for
any Comprehensive or Plus version.

4. Set the NCPAP (Low Pressure) Flow Meter to about 8 LPM then push the softkey button
below the left flowmeter icon (Figure 1).

5. Set the %O2 to 100% then push the softkey button below the blender icon.

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Figure 1

80 Infant Flow

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SiPAP

6. Set the pressure High Flow Meter to about 2 LPM then push its softkey button under the
right flowmeter icon.

7. The Respiratory Sensor option is not required, but to finish, select this soft key button.

8. Accept the NCPAP settings by selecting the NCPAP soft key. (%O2 should display 100)
(Figure 2).

Figure 2

9. The next screen varies but select BiPhasic soft key (Figure 3).

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Figure 3

Service Manual 81

10. Accept the default BiPhasic settings by selecting the BiPhasic soft key again (Figure 4).

Figure 4

11. Verify that the measured value doesn’t exceed 23% FiO2. If so, then troubleshoot for an

oxygen leak. Check all the fittings and connections and repeat the Oxygen Leak Test
(Figure 5).

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Figure 5

82 Infant Flow

®

Appendix B- Product Configurations

Non-US Configuration Parameters

Parameter Min Max Accuracy Units

Set Oxygen concentration, %O2 21 100
CPAP flow rate 0 15
Bi-level additional flow rate 0 5
BiPhasic on time, Ti (inspiration time) 0.1 3.0 *
BiPhasic rate, R (respiration rate) 1 120
BiPhasic Tr backup rate, Rb (backup

respiration rate)
Breath rate timeout 10 30

* Ti automatically reduces at higher R and Rb rate settings to maintain a minimum off time of 100
milliseconds.

1 120

±3
±15%
± 15%
± 0.005
± 0.5
± 0.5

± 1

%
L/min
L/min
seconds
pm
pm

seconds

SiPAP

US Configuration Parameters

Parameter Min Max Accuracy Units

Inspired oxygen fraction, FiO2 21 100
CPAP flow rate 0 15
Bi-level additional flow rate 0 5
BiPhasic on time, Ti (inspiration time) 0.1 3.0 *
BiPhasic rate, R (respiration rate) 1 54
Breath rate timeout 10 30

* Ti automatically reduces at higher R and Rb rate settings to maintain a minimum off time of 1000
milliseconds.

±3
±15%
± 15%
± 0.005
± 0.5
± 1

DEFAULT SETTINGS

Inspiration Time Ti: 0.3 seconds (1.0 sec U.S) +/- 1%.
Rate during BiPhasic modes R: 30 / minute (10 / minute U.S.)
Back Up Rate During BiPhasic Tr Rb: 10 / minute
Apnea Interval T

: 20 seconds (+/- 1%)

apnea

%
L/min
L/min
seconds
Pm
Seconds

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Service Manual 83

Appendix C - Spare Parts

To identify a part referenced in this manual, refer to the as sociated F igure a nd Item
number in Table 8.

Table 8 - Spare Parts

Figure Item Number Part Name Part Number

13 3 Battery 777244

14 3 Filter 467464

4 O-ring, 7/16” x 9/16” 465476

15 3 Filter/Restrictor 672-024-SA

4 O-ring, 1/8” x ¼” 465474
5 O-ring, ¼” x 3/8” 465457

16 4 Fuel Cell 467352

17 12 O-ring, 7/16” x 9/16” 465476

13 Valve/Sensor PCB Assembly 777245

22 Blender 675-213
26 Pilot Drive Check Valves 675-230

18 2 Water Trap Filter 467269

3 Case Bleed Filtered Restrictor 467542

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84 Infant Flow

Additional Service Parts

Part Number Description

467472 KNOB GREY 6MM SHAFT (LOW FLOWMETER)
467468 CAP PLAIN GREY OD29
467471 POINTER GREY OD29
467469 KNOB GREY 3/16 SHAFT (HIGH FLOWMETER)
467470 CAP PLAIN GREY OD15
675-308 CASE
467467 FOOT, POLYURETHANE .5OD
467466 WASHER M3 CRINKLE BECU (FOR CASE)
675-200 FLOWMETER MK3 HIGH (2-15)
675-201 FLOWMETER MK 3 LOW (0-4-5)
B09220 FLOWMETER, 0-15 LPM OXYGEN
777244 PACKAGED BATTERY, MK3
467463 SPACER ROUND M4X155MM NYLON
675-206 COMPRESSION PAD
467462 FILTER, WATERTRAP
M673051 WATERTRAP TOOL
465476 O-RING, 7/16" X 9/16"
672-024-SA ASSEMBLY, FILTER
465457 O-RING, 1/4" x 3/8"
465474 O-RING, 1/8" x 1/4"
467268 O-RING, 1-3/16 x 1-5/16
690-024 DIAPHRAGM
467352 FUEL CELL
675-230 PILOT DRIVE DUCKBILL ASSY
467542 CASE BLEED FILTER RESTRICTOR
777245 VALVE/SENSOR PCB (PACKAGED ASSEMBLY)
677-005 PATIENT TRIGGER CONTROLLER PCB
675-311 PATIENT TRIGGER CABLE
S117635 ASSY PCB MAIN PROCESSOR
467461 LCD 5.5 INCH
467460 PCB BACKLIGHT INVERTER LCD
675-260 LCD CABLE 12
675-257 LED BOARD CABLE-6
467459 FUSE TIME LAG 2.5A 250V
467458 POWER INPUT TWIN FUSE
675-307 AUX FLOW MOUNTING BLOCK
675-213 ASSY BIRD BLENDER
B10003 MAINT KIT MCRBLNDR+LOFLO

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SiPAP

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Service Manual 85

Part Number Description

675-300 EXHAUST TUBE 90 DEGREE
675-101 OPS MAN INF FLOW SiPAP
677-002 TRANSDUCER INTERFACE
467349 ABDOMINAL RESP SENSOR 25PK
B03895 VALVE CHECK DCKBL BLACK
467464 FILTER NYLON CONE INL
467269 FILTER ELEMENT (WATERTRAP)
777235 POWER SUPPLY MK3
467455 SWITCH COVER
675-256 SWITCH CABLE ASSY
S117641 ASSY PCB LED AMBIENT SENSOR
M675A-FRONT FRONT PANEL ASSY
675-312 CONNECTOR PATIENT INLET
675-316 MK3 TRIGGER LEUR
675-209 O2 SENSOR CABLE
777061 BLOCK, INLET O2/AIR System
777242-101 SERVICE KIT, Mk3 DRIVER ANNUAL
777242-102 SERVICE KIT, Mk3 DRIVER 2 YEAR
777242-103 SERVICE KIT, Mk3 DRIVER 5 YEAR
777072-101 ASSY O2 /AIR FITTINGS MARK III DISS
777072-102 ASSY O2 AIR FITTINGS MARK III NIST
777072-103 ASSY O2 /AIR FIT MARKIII FEMALE DISS
777072-103 ASSY O2 AIR FIT MARKIII AIR LIQUIDE
675-821 SWR MK3 IFD DOWNLOAD UTILITY
675-819 MK3 DOWNLOAD CABLE

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86 Infant Flow

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SiPAP

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Service Manual 87

Glossary

Term Meaning

Apnea

Bpm
Bps Bytes per second

cmH2O Centimeters of Water (Pressure)
CPAP Continuous Positive Airway Pressure
FiO2 Fraction of Inspired Oxygen

Generator
I/E Inspiration/Expiration ratio

IFSD Infant Flow SiPAP Driver
LBR Low Breath Rate monitoring (US labeling)
L/min Liters per minute
MAP Mean Airway Pressure

BiPhasic
BiPhasic+Apnea BiPhasic Ventilation with Apnea monitoring (non-US labeling)

Temporary inability to breathe; monitoring of breathing (non-US
labeling)

Breaths per minute (applies to each of spontaneous, triggered
and mandatory)

Patient attachment for delivering CPAP, used with nasal prongs or
mask

BiPhasic Ventilation - CPAP with additional pressure pulses,
time-triggered and time-cycled

BiPhasic +LBR BiPhasic with low breath rate monitoring (US labeling)
BiPhasic Tr
NCPAP Nasally applied CPAP

NCPAP+LBR NCPAP with Low Breath Rate monitoring (US labeling)
NCPAP+Apnea NCPAP with Low Breath Rate monitoring (non-US labeling)
Non-US labeling Labeling using non-linguistic symbols in place of English text
PEEP Positive End-Expiratory Pressure
PIP Peak Inspired Pressure
BiPhasic Flow Inspiratory Pressure

PRS
Rate Mandatory BiPhasic rate (per minute)

RB
RSP Patient’s spontaneous respiratory rate (per minute)

s / sec Seconds

Triggered BiPhasic Ventilation - CPAP with additional pressure
pulses, patient-triggered and time-cycled

Product Requirement Specification. A fully controlled baseline
document

Backup ventilator rate (in BiPhasic Tr mode during apnea alarm,
per minute; non-US labeling)

675-120 Revision C November 2004

88 Infant Flow

Term Meaning

Sigh A single pulse of additional gas flow

Apnea Interval (non-US labeling) or Low Breath Rate (LBR)

T

/ T

apnea

LBR

Ti Machine breath inspiration time (seconds)

monitor alarm time (US-labeling); both in seconds
This mnemonic may also be associated with an alarm icon 

®

SiPAP

Treatment

Application of NCPAP, BiPhasic, BiPhasic Tr, with or without
breath monitoring, to the patient

US labeling Labeling using English text in place of symbols and/or icons

675-120 Revision C November 2004