CareFusion Infant Flow SiPAP M675 User manual
Infant Flow® SiPAP™ Model M675
Service manual
ii Infant Flow
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This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any
form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the
written permission of CareFusion. Information in this document is subject to change without notice.
This document is for informational purposes only and should not be considered as replacing or
supplementing the terms and conditions of the License Agreement.
© 2008 – 2010 CareFusion Corporation or one of its subsidiaries. All rights reserved Infant Flow SiPAP
model M675 is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other
trademarks are property of their respective owners.
USA
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, California 92887-4668
800.231.2466 tel
+1.714.283.2228 tel
+1.714.283.8493 fax
Authorized European Representative
CareFusion Germany 234 GmbH
Leibnizstrasse 7
97204 Hoechberg, Germany
District Court Wuerzburg HRB7004
+49.931.4972.0 tel
+49.931.4972.423 fax
®
SiPAP
carefusion.com
Literature number: 675–120 Revision F
675–120 Rev. F
Service Manual iii
Revision History
Date Revision Changes
September 2003 675-120(1) Release
November 2004 B
December 2004 C
May 2005 D
Release manual in VIASYS Healthcare template using
VIASYS Healthcare Respiratory Care nomenclature.
Revised per EO 27980. Removed the picture
from the title page.
Deleted the ESD warning from page 19.
Removed “O2 Sensor” and added the word “measured”
on page 30.
Changed “O2 sensor” to “fuel cell” on pages 39, 45, 62,
68, 69, 73, 86, and 87.
Replaced the O2 senor row on page 50.
Updated the error codes on pages 56 and 57.
Replaced the warning on page 61.
Changed the Fitting procedure on pages
64, 68, and 75.
Changed step 6 on page 65.
Added Addendum A – Oxygen Leak Test
Changed Transducer Assy. To Transducer Interface on
page 88.
Revised per ECO 60329
Update address/contact info
Update battery remove/install procedure
Added note for fuel cell disposal
Update check valve assembly remove/install procedure
Update water trap & restrictor remove/install procedure
Delete redundant leak test
Update list of service parts
August 2008 E
675-120 Rev. F
Updated company information
Updated company information
Corrected Table 2 and updated Table 3
Updated Figure 6
Updated Figure 10
Updated the section “Diagnostics.”
Updated Table 6 starting on page 43
iv Infant Flow
Date Revision Changes
April 2010 F Changed Ti to T-High throughout
Figure 5 - Diagnostic screen updated
Spelling correction from “GRD” to “GND”
Added “Note: transducer must be attached.”
Changed “10 V” to “11.10 V”
Updated Table 6 - Error Codes (E50 - E54) and added
E55
Removed “Blender (Check Valves and Filter) Annually”
from table 7.
Added “, and two screws on the case-bottom”.
Added “and document L2879”
Replaced Ti symbol with T-High symbol
Changed “PL5” to “PL2”
Replaced Figure 3
Replaced Figure 4 and 5. Changed “value doesn’t” to
“value on the external oxygen analyzer doesn’t”.
Changed “467352” to “68289”; changed “777245” to
“52700A”; removed items 677-005A, 675-311, S117635,
467461, 467460.
Removed item S117641; changed “675-310” to “M675AFRONT”
®
SiPAP
675-120 Rev. F
Service Manual v
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 CareFusion, (referred to as the Company) under this warranty is
limited to replacing, repairing or issuing credit, at the discretion of the Company, for
parts that become defective or fail to meet published specifications during the
warranty period; the Company will not be liable under this warranty unless (A) the
Company is promptly notified in writing by Buyer upon discovery of defects or failure
to meet published specifications; (B) the defective unit or part is returned to the
Company, transportation charges prepaid by Buyer; (C) the defective unit or part is
received by the Company for adjustment no later than four weeks following the last
day of the warranty period; and (D) the Company’s examination of such unit or part
shall disclose, to its satisfaction, that such defects or failures have not been caused
by misuse, neglect, improper installation, unauthorized repair, alteration or accident.
Any authorization of the Company for repair or alteration by the Buyer must be in
writing to prevent voiding the warranty. In no event shall the Company be liable to
the Buyer for loss of profits, loss of use, consequential damage or damages of any
kind based upon a claim for breach of warranty, other than the purchase price of any
defective product covered hereunder.
The Company warranties as herein and above set forth shall not be enlarged,
diminished or affected by, and no obligation or liability shall arise or grow out of the
rendering of technical advice or service by the Company or its agents in connection
with the Buyer's order of the products furnished hereunder.
Limitation of Liabilities
This warranty does not cover normal maintenance such as cleaning, adjustment or
lubrication and updating of equipment parts. This warranty shall be void and shall not
apply if the equipment is used with accessories or parts not manufactured by the
Company or authorized for use in writing by the Company or if the equipment is not
maintained in accordance with the prescribed schedule of maintenance.
The warranty stated above shall extend for a period of One (1) year from date of
shipment, with the following exceptions:
1. Components for monitoring of physical variables such as temperature,
pressure, or flow are warranted for ninety (90) days from date of receipt.
2. Elastomeric components and other parts or components subject to
deterioration, over which the Company has no control, are warranted for sixty
(60) days from date of receipt.
3. Internal batteries are warranted for ninety (90) days from the date of receipt.
The foregoing is in lieu of any warranty, expressed or implied, including, without
limitation, any warranty of merchantability, except as to title, and can be amended
only in writing by a duly authorized representative of the Company.
675-120 Rev. F
vi Infant Flow
®
SiPAP
Contents
Revision History ............................................................................... i
Warranty .......................................................................................... v
Limitation of Liabilities ................................................................... v
Notices .......................................................................................... viii
EMC Notice ............................................................................................................... viii
MRI Notice ................................................................................................................. viii
Intended Use Notice ................................................................................................... ix
Regulatory Notice ....................................................................................................... ix
Classification .............................................................................................................. ix
Declaration of Conformity Notice ................................................................................. x
Chapter 1 – Product Description ........................................................ 1
Chapter 2 – Product Specifications .................................................... 3
Modes .......................................................................................................................... 3
Controls ....................................................................................................................... 3
Monitors ....................................................................................................................... 3
Alarms ......................................................................................................................... 4
Pneumatic Supply ........................................................................................................ 4
Electrical Supply .......................................................................................................... 4
Atmospheric & Environmental ...................................................................................... 5
Physical ....................................................................................................................... 5
Chapter 3 – Warnings and Cautions ................................................... 7
Terms .......................................................................................................................... 7
Warnings ..................................................................................................................... 7
Cautions ...................................................................................................................... 9
Chapter 4 – System Construction ..................................................... 11
Touch Screen ............................................................................................................ 15
Alarm Conditions ....................................................................................................... 17
Diagnostic Screen ...................................................................................................... 17
Chapter 5 – Operation ....................................................................... 19
Gas Flow ................................................................................................................... 19
Electronic Functions .................................................................................................. 22
Electrical Layout ........................................................................................................ 23
Fault Management ..................................................................................................... 24
Chapter 6 – Operation ....................................................................... 25
Preparing and Connecting the Equipment.................................................................. 25
Switching On the IFSD ............................................................................................... 28
Alarms Test ............................................................................................................... 29
Infant Flow
Setting Up the Equipment .......................................................................................... 32
Setting the NCPAP Parameters ................................................................................. 33
®
SiPAP™ User Verification Test Checklist ............................................... 31
675-120 Rev. F
Service Manual vii
Setting the BiPhasic Parameters ................................................................................ 34
Setting the Triggered BiPhasic Parameters ................................................................ 35
Calibration .................................................................................................................. 37
Giving a Manual Timed Sigh ...................................................................................... 37
Operation Without Electrical Power ............................................................................ 37
Fault Indications ......................................................................................................... 38
Diagnostics ................................................................................................................ 44
Chapter 7 – Maintenance ................................................................... 51
Cleaning ......................................................................................... 51
Maintenance ................................................................................... 51
General ...................................................................................................................... 51
Maintenance Frequencies .......................................................................................... 52
Removal and Fitting of Case ...................................................................................... 53
Removal and Fitting of Battery ................................................................................... 54
Removal and Fitting of Oxygen Filter ......................................................................... 55
Removal and Fitting of Fuel Cell Filter/Restrictor ....................................................... 56
Removal and Fitting of the Fuel Cell .......................................................................... 57
Removal and Fitting of Blender and Components ...................................................... 58
Removal and Fitting of Water Trap Filter .................................................................... 62
Removal and Fitting of Case Bleed Filtered Restrictor ............................................... 63
Removal and Fitting of PA Solenoid Valve ................................................................. 64
Chapter 8 – Explanation of Symbols ................................................ 65
Appendix A – Oxygen Leak Test ....................................................... 69
Appendix B – Product Configurations .............................................. 73
Non-US Configuration Parameters ............................................................................. 73
US Configuration Parameters .................................................................................... 73
Appendix C – Spare Parts .................................................................. 75
Appendix D – Pneumatics Assembly ................................................ 79
Glossary .............................................................................................. 81
675-120 Rev. F
viii Infant Flow
Notices
EMC Notice
This equipment radiates and is susceptible to radio frequency energy. If not installed
and used in accordance with the instructions in this manual, electromagnetic
interference may result. The equipment has been tested and found to comply with
the limits set forth in BS EN60601-1-2 for Medical Electrical Equipment Part 1-2:
General requirements for safety-collateral standard. Electromagnetic compatibility –
requirements and tests. These limits provide reasonable protection against
electromagnetic interference when operated in the intended use environments (e.g.
hospitals) described in this manual.
This device is also designed and manufactured to comply with the following
standards;
Safety: UL 60601-1: 2003 Medical Electrical Equipment, Part 1: General
Requirements for Safety.
CAN/CSA C22.2 No 601.1-M90, Medical Electrical Equipment - Part
1: General Requirements for Safety including C22.2 No. 601.1S1-94
(IEC601-1, Amendment 1:1991) Supplement No. 1-94 to CAN/CSA
22.2 No. 601.1-M90
®
SiPAP
With regards to Electrical Safety:
Class 1 equipment
Contains type BF patient applied parts
Continuous Operation
MRI Notice
This equipment contains electromagnetic components whose operation can be
affected by intense electromagnetic fields.
Do not operate this device in a MRI environment or in the vicinity of high-frequency
surgical diathermy equipment, defibrillators, or short-wave therapy equipment.
Electromagnetic interference could disrupt the operation of the device.
675-120 Rev. F
Service Manual ix
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.
Operators of this equipment and Service Engineers are required to read and thoroughly
understand the contents of this manual before using or maintaining the equipment.
This manual is intended for use by a competent, fully qualified Service
Engineer. It includes a description of the unit and how it works. It also contains
operating and diagnostic procedures and maintenance instructions. For usage
of associated equipment, refer to the Manufacturer’s literature.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
Classification
Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1
Protected, and uses type BF applied parts. Equipment is not suitable for use in
presence of flammable anesthetics.
675-120 Rev. F
x Infant Flow
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and
the following Technical Standards, to which Conformity is declared:
Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4)
Safety: EN 60601-1, EN 794-1
EMC: EN 60601-1-2:2001
Conformity Assessment: MDD Annex II
Quality System: ISO 13485
EU Notified Body: BSI (Reg. No. 0086)
Device Classification: IIb
®
SiPAP
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
Infant Flow SiPAP
Manufactured by:
CareFusion
22745 Savi Ranch Parkway
Yorba Linda, CA 92887, USA
If you have a question regarding the Declaration of Conformity for this product,
please contact CareFusion.
675-120 Rev. F
Service Manual 1
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
CareFusion. These accessories include circuits and generators, prong and mask
patient interfaces and bonnets.
®
SiPAP is currently available in a Plus or Comprehensive
®
SiPAP comes standard in all configurations with an LCD touch screen
and up to 2 hours of backup battery power.
2
®
SiPAP has been proven
®
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.
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.
®
Generator - The Infant Flow® Generator is a fluidic device for
675-120 Rev. F
2 Infant Flow
• •
• •
•
•
• •
•
•
•
• •
•
• •
•
•
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*
®
SiPAP
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 CareFusion representative.
675-120 Rev. F
Service Manual 3
Chapter 2 – Product Specifications
Modes
• NCPAP
• NCPAP with breath rate monitoring and low rate alarm
• BiPhasic (time triggered)
• BiPhasic (time triggered) with breath rate monitoring and low rate alarm
• BiPhasic tr (patient triggered ) with breath rate monitoring, low breath rate
alarm, and apnea back up
Controls
• Inspiratory Time (T-High): 0.1-3.0 seconds
• Rate (R): 1-120 (Comprehensive only. The comprehensive configuration is
not available for sale in the United States.)
• Rate (R): 1-54 (Plus only)
• Apnea Interval (T
• Apnea Interval (T
• NCPAP/Pres Low flowmeter: 0-15L/min, accuracy +/- 15% of selected output
• NCPAP/Pres High flowmeter: 0-5L/min, accuracy +/- 15% of selected output
• Manual Breath: X 1
• Rate monitoring on/off: NCPAP
• %O
Monitors
• CPAP
• PEEP
• MAP
• PIP
• %O
• I:E ratio
apnea): 10-30 seconds, 5 second intervals (Comp* only)
LBR): 10-30 seconds, 5 second intervals (Plus only)
: 21 - 100% - accuracy +/-3%
2
2
• Spontaneous rate (Rs)
• Battery charge level
675-120 Rev. F
4 Infant Flow
Alarms
• High airway pressure – 3 cmH20 above measured airway pressure
• High circuit pressure – maximum 11 cmH20 in time triggered Biphasic mode
• High circuit pressure – maximum 15 cmH20 in patient triggered Biphasic tr
mode (Comprehensive only. The comprehensive configuration is not
available for sale in the United States.)
• Low airway pressure – 2 cmH20 below measured airway pressure or 1
cmH20 if otherwise would be zero
• High and Low delivered Oxygen concentration +5% of setting
• Low breath rate alarm
• Low or Flat battery charge level
• Alarm volume (electronic alarms) 70 dBa at 1 meter
Pneumatic Supply
• Patient Gas Outlet: 15 mm standard taper fitting
®
SiPAP
• Patient Pressure Input: 4.5 mm Luer taper fitting
• Gas Supply: Nominal 4 bar or 60 psi, clean, dry medical air and oxygen
• Range: 2.8 to 6 bar (40 to 90 psi); maximum differential pressure 2 bar
(30 psi)
• Manometer: Range 0 to + 20 cmH2O, accuracy, ± 2% of span
• Gas Connections: Standard DISS or NIST connectors
Electrical Supply
• Input Voltage:100-230 VAC
• Input Frequency: 50/60 Hz
• Power Consumption: 50 VA maximum
• Fuse Rating For 220 V nominal operation: “T” Type 2.5 A at 250 V
• Device Housing Protection rating level: IPX1
• Battery Working Time: 2 hours (from fully charged state)
• Battery Charging Time: max. 16 hours
675-120 Rev. F
Service Manual 5
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
675-120 Rev. F
6 Infant Flow
®
®
SiPAP
Infant Flow
SiPAP™
Model M675
675-120 Rev. F
Service Manual 7
Chapter 3 – 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 technical support at CareFusion.
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.
• 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.
675-120 Rev. F
8 Infant Flow
• 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.
®
SiPAP
• 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.
• Verify that the displayed value for delivered FiO
corresponds to the value set
2
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 Rev. F
Service Manual 9
Cautions
• Federal Law (USA) restricts this device to sale by or on the order of a
physician.
• The precision gas blender in this product may become non-functional or
damaged if used without the protective water trap and filters provided.
• The power switch on this unit does not isolate the external power supply.
Disconnect the power supply cable to ensure complete isolation.
• Before use, 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 CareFusion
representative.
• Where the integrity of the external protective earth conductor is in doubt, the
equipment shall be powered by its internal power source (battery).
• Do not immerse any part of the IFSD in water or sterilize it with gas or steam.
• Ensure patient breathing circuit is replaced at regular intervals.
675-120 Rev. F
10 Infant Flow
®
®
SiPAP
Infant Flow
SiPAP™
Model M675
675-120 Rev. F
Service Manual 11
Chapter 4 – System Construction
CAUTION
Where the integrity of the external protective earth conductor is in doubt the
equipment shall be powered by its internal power source (battery).
The IFSD is AC powered with an integral rechargeable DC battery that provides
power for up to two hours without any interruption of performance or function. If the
AC power supply fails or is disconnected, the IFSD automatically switches to battery
power and gives an audio and visual alarm.
The IFSD is enclosed in a case with Operator controls and input connectors on the
front and rear panel. The front panel is shown in Figure 1. The back panel is shown
in Figure 2. The case incorporates non slip feet for table top use or must be fitted to
a dedicated stand. The major components within the casing are:
• a gas module
• an electronics module
• a front panel module
• a patient trigger module
• a firmware module
675-120 Rev. F
12 Infant Flow
®
SiPAP
Figure 1: IFSD Front Panel
Gas Module
The function of the gas module is to take air and oxygen, blend them into the
required mixture and deliver this mixture to the patient at the prescribed flow rate.
The gas module also measures the oxygen concentration, measures the patient
pressure, provides an auxiliary gas outlet (optional) and provides switched Biphasic flow.
The main components are an air/oxygen blender, a flow manifold, a vent valve, an
exhaust manifold with alarm whistle, NCPAP Pres low and NCPAP Pres high flowmeters,
and a valve/sensor PCB. The inlet gas connections are on an 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 Rev. F
Service Manual 13
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.
Figure 2: IFSD Back Panel
Leak Test
Port
675-120 Rev. F
14 Infant Flow
®
SiPAP
Figure 3: IFSD Internal Components
675-120 Rev. F
Service Manual 15
Front Panel Module
The function of the front panel module is to house the gas and electrical connections
to the patient, Operator controls and indicators. The module consists of a front panel
plate, the touch screen with key pad, flowmeters and FiO
and indicators and an ambient light sensor. The backlight on the touch screen is
decreased if the ambient light sensor detects a low ambient light level and increased
if it detects a high ambient light level.
The green Power light is always on when AC power is connected to the unit.
control, patient connectors
2
The Alarm Warning Bar
Patient Trigger Module (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 and apnea and give this information to the
main processor in the electronics module. The main processor uses the signals from the
patient trigger module to instruct the biphasic pressure control to provide a timed sigh
to the patient.
Firmware Module
The firmware module is the unit’s embedded software. Its function is to instruct the
microprocessor how to control the unit and to interact with the Operator.
Touch Screen
The touch screen provides the Operator with a series of screens with icons to enable
settings, calibration and fault diagnosis. The Start Up Screen is shown in Figure 4.
The display includes a status bar which incorporates a battery status, mode
indicator, alarm button and patient trigger indicator. The center part of the display
shows icons which relate to the function being selected or performed. The display also
includes a key pad with six keys. The icon in each key changes depending on the
function being performed.
flashes red to indicate an alarm.
Battery Status and 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
alarm condition, the button is solid
675-120 Rev. F
. 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
yellow with an audible alarm. If any
16 Infant Flow
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).
®
SiPAP
Figure 4: Touch Screen Display – Start Up
Patient Trigger Indicator (Plus and Comprehensive Models)
The Patient Trigger indicator changes to when the transducer interface is
connected and ready to be connected to the patient and indicates a
transducer interface is not connected.
when the
675-120 Rev. F
Service Manual 17
Alarm Conditions
Audible and visible alarm indications are given to alert the Operator to specified
conditions that affect the operation of the unit. The electronic alarm limits are
automatically set after two minutes without Operator inputs but the Operator can
manually set the alarm parameters for certain conditions if required. The IFSD has
the following alarms:
• an audible 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.
Figure 5: Diagnostic Screen
675-120 Rev. F
18 Infant Flow
PCB. Position 1 is on and 0 is off.
INDICATOR
contrast.
Box
Description
PT
The PT box shows the status of the Patient Trigger module.
RS232
The RS232 box shows factory set data.
Table 2 - Diagnostics Screen Boxes
Box Description
DIPS The DIPS box shows the position of the DIP switches on the main processor
®
SiPAP
CONTRAST
CALIBRATION
INDICATOR
The contrast indicator box is for use in the factory for setting the screen
The calibration indicator box shows
successfully completed and a
if the calibration fails.
during calibration, a when
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 Diagnostics Screen Boxes
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
CONFIG The CONFIG box shows the software configuration based on the DIP switch
LCD The LCD box shows the ambient light sensor voltage (AMB), the back light level
PSU The PSU box shows the external power supply voltage (EXT), the battery voltage
RAILS The RAILS box shows the ground voltage (GND), and the control voltages (6.5,
2
P).
(E
settings and requirements. LAB = INTL or US (controlled by DIP 3), which is the
Comprehensive or Plus model; tBiP = 1 or 0 (controlled by DIP 2 and 5), which
indicates Triggered BiPhasic is enabled (1) or disabled (2); APB = 1 or 0
(controlled by DIP 2), which indicates that Apnea BiPhasic is enabled (1) or
disabled (0); The remaining symbols provide the default and ranges for
inspiratory time, and breath rate (controlled by DIP 1).
(BLL) and if the backlight is operative (BLF - 1 for fail, O for on).
(BAT), the battery charge status (CHG) and the temperature (TMP).
8.2 and 10 V).
PRESSURE The PRESSURE box shows cm H2O pressure value, the voltage from the
pressure sensor (PSEN) and the software offset (OFFS) and gain (GAIN)
values.
OXYGEN The OXYGEN box shows the FiO2 %, the voltage from the oxygen sensor
(OSEN) and the software offset (OFFS) and gain (GAI N) values.
ZVALVE The ZVALVE box shows if the Z DRIVE is operative (ZDRV - 1 for fail, O for on)
for the zero valve and the Z sensor (ZSEN) voltage.
DVALVE The DVALVE box shows if the D DRIVE is operative (DDRV - 1 for fail, O for on)
for the dump valve and the D sensor (DSEN) voltage.
PVALVE The PVALVE box shows if the P DRIVE is operative (PDRV - 1 for fail, O for on)
for the pressure assist valve and the P sensor (PSEN) voltage.
675-120 Rev. F
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