CareFusion Infant Flow SiPAP M675 User manual

Infant Flow® SiPAP™ Model M675

Service manual

ii Infant Flow

This document is protected by United States and International Copyright laws.

This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of CareFusion. Information in this document is subject to change without notice.

This document is for informational purposes only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement.

© 2008 – 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

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.

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

• 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%

• 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

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

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

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

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,

P).

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

Service Manual 19

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

A vent valve on the exhaust manifold incorporates a solenoid operated pilot valve and a large orifice spool valve. The vent valve is normally held in the open position by a spring to vent high flow rates with low pressure drops so that the patient pressure is minimal. The electrically actuated pilot valve is operated by blended gas so that the vent valve continues to operate if one gas supply is lost.

Blended gas flows through an electronically operated dump valve which is normally in the closed position. If over pressurization occurs, the sensors detect the condition and the controller signals the dump valve to open, sounds an alarm buzzer and at the same time closes the vent valve to rapidly reduce the patient pressure to near zero. When the over pressure condition stops, the controller signals the vent valve to open and the dump valve to close.

The NCPAP flowmeter is set by the Operator to the required flow. The flow rate is shown on the gauge on the flowmeter. When the flowmeter control knob is turned fully clockwise, the flow of gas is turned off.

675-120 Rev. F

20 Infant Flow

SiPAP

Figure 6: IFSD Gas Flow Schematic

675-120 Rev. F

Service Manual 21

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 flowmeter is set by the Operator to the 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.

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.

level. In

675-120 Rev. F

22 Infant Flow

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.

SiPAP

Figure 7: IFSD Electronic Enclosure

675-120 Rev. F

Service Manual 23

Electrical Layout

Figure 8 shows the electrical wiring and PCB connector layout.

Figure 8: IFSD Electrical Wiring Diagram

675-120 Rev. F

24 Infant Flow

BiPhasic

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

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

Battery status shows discharged battery.

Unit inoperable by software, operable in unpowered

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

   

  

     

NCPAP+

Apnea

+ Apnea

X X



675-120 Rev. F

Service Manual 25

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.

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.

675-120 Rev. F

26 Infant Flow

SiPAP

Figure 9: Patient Connections

WARNING

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

675-120 Rev. F

Service Manual 27

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 expiratory flows via the specially designed generator and nasal prongs. This 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 airway pressure and flow settings is shown in Figure 10. Example: 8 L/min gas flow provides 5 cm H

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

675-120 Rev. F

Figure 10: Flow Pressure Nomogram

28 Infant Flow

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.

SiPAP

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 the section “Calibration” on page 37.

Note

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

675-120 Rev. F

Service Manual 29

Alarm Test Initial Settings

NCPAP / Pres Low flow meter

For Step 9 Use the settings provided below

LBR

Alarms Test

WARNING

Prior to patient application, ensure that all User Verification testing and calibration procedures are successfully completed. User Verification testing and calibration procedures must be done off patient.

NOTE

Following each alarm verification test, ensure that control settings and alarm limits are reset as instructed before proceeding to the next test.

Air Supply Pressure

Supply Pressure

Patient Circuit

Generator

% O2

Pres High flow meter

Mode

Rate

T-High

Tapnea (Non-U.S. Configuration) / T

(U.S. Configuration)

Perform the Alarms Test on the Infant Flow® SiPAP™ using the following steps and the initial settings provided above.

1. Make appropriate connections for air and O

to appropriate AC outlet. Attach patient circuit, generator and patient interface (mask or prong) as shown in Figure 3. Occlude the opening to the patient.

2. Power up the driver and allow Power On Check to complete.

3. Low airway pressure alarm: From NCPAP operating mode, with alarms set,

remove occlusion from opening to patient. Verify that the low airway pressure alarm activates. Restore the patient interface occlusion and press the Alarm Mute / Silence button for 3 seconds to reset the alarms.

4. High airway pressure alarm: Adjust the NCPAP / Pres Low flow meter to 11

L/min. Verify that the high airway pressure alarm activates. Return the NCPAP / Pres Low flow meter to 8 L/min and press the Alarm Mute / Silence button for 3 seconds to reset the alarms.

> 30 psig (2.1 bar)

Infant Flow® Patient Circuit

Infant Flow® Generator

8 L/min (for delivery of 5 cmH2O)

30%

3 L/min

NCPAP

30 bpm

0.3 sec

20 sec

gas supply. Connect power cord

675-120 Rev. F

30 Infant Flow

SiPAP

5. High %O2 Alarm: Adjust the % O2 control to 35%. Verify that the High %O

alarm activates. Return the O2 control setting to 30%. Reset alarms by pressing the Alarm Mute / Reset button for 3 seconds.

6. Low % O

Alarm: Adjust the % O2 control to 25%. Verify that the Low %O

alarm activates. Return the O2 control setting to 30%. Reset alarms by pressing the Alarm Mute / Reset button for 3 seconds.

7. Loss AC Alarm: Disconnect the AC power cord from the wall outlet. Verify that the Loss AC alarm activates. Reconnect the AC power cord. Clear the alarm by pressing the Alarm Mute / Reset button.

8. High Circuit Pressure Alarm: Increase nCPAP pressure to 11.1 cmH

O by

increasing the NCPAP/PRES Low Flow meter. Verify that the High Circuit pressure alarm activates. Return NCPAP/PRES Low Flow meter to 8 LPM and press the Alarm Mute/Silence button for three seconds to reset the alarms.

9. Low Breath Rate (Apnea) Alarm: Attach the transducer to the unit. Select and confirm BiPhasic+Apnea/LBR (U.S. Configuration). Change the mandatory rate control to setting for rate to 1 bpm. Verify that the Low Breath rate alarm activates after the default interval of 20 seconds. Return the rate control to 30 bpm and clear the alarm by pressing the Alarm Mute / Reset button for 3 seconds. Note: transducer must be attached.

675-120 Rev. F

Service Manual 31

Power On Check

Low Airway Pressure Alarm

High Airway Pressure Alarm

Infant Flow® SiPAP™ User Verification Test Checklist

Driver Serial Number:_____________________ Test Date:_________________

TEST PASS FAIL

Automated Tests

Manual Tests

Two Point O2 Sensor Calibration Patient Circuit Leak test

Manual Alarms Checks

High O

Low O Loss AC Alarm

High Circuit Pressure Alarm Low Breath Rate (Apnea) Alarm

Alarm

Signature of tester:_______________________________________________

Title___________________________________________________________

675-120 Rev. F

32 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

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.

if the patient trigger is connected.

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 Rev. F

Service Manual 33

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 button. When the settings have been accepted, the screen changes to the Locked Screen.

Touch the

• the display changes to the Parameter Adjust Screen

675-120 Rev. F

button to unlock the key pad.

34 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 (T

• the NCPAP Pres high respiration rate (R)

• the Inspiration/Expiration ratio (I/E)

-High)

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 T

Tapnea. Use the buttons to set the parameter for T-High, Rate, and Tapnea.

-High, Rate, and

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.

Parameters T

675-120 Rev. F

-High and Rate can now be adjusted.

button.

Service Manual 35

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

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

button to unlock the keypad.

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 (T

• the NCPAP Pres high backup respiration rate (Rb)

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

-High)

Press each individual button to select between the parameters T

Tapnea. Use the

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.

675-120 Rev. F

-High, Rb and

buttons to set the parameter for T-High, Rb and Tapnea.

36 Infant Flow

To adjust the parameters, touch the button.

The screen changes to the BIPHASIC TR Adjust Screen.

SiPAP

Parameters T

To return to the Mode Selection Screen, touch the

-High, Rb and Tapnea can now be adjusted.

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.

675-120 Rev. F

Service Manual 37

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

Touch the

The screen returns to the Start Up Screen .

control to 21 and confirm by touching the flashing button.

control to 100 and confirm by touching the flashing button.

button.

Note

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

fuel cell.

Giving a Manual Timed Sigh

In the Mode Select or Adjust 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

675-120 Rev. F

38 Infant Flow

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.

SiPAP

• 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

• 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 fault by adjustment of the high pressure and touch the warning button for three seconds to reset.

675-120 Rev. F

Service Manual 39

returns to normal.

Table 5 - Faults and Indications

Alarm Method of Setting

Minimum oxygen concentration

18 FiO2).

Over pressure (Patient pressure > 11 cmH

O when in

Always active when power is on.

NCPAP mode).

Indications and Actions

Intermittent high level Audible Alarm.

Warning Bar flashes.

display flashes.

FiO

Digital O

alarm low

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

Method of Resetting or Canceling

Restore FiO

level to

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.

High oxygen concentration

5 FiO2 above set point

(> at time alarm is set for 15 seconds, or

104 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.

Intermittent high level Audible Alarm. Warning Bar flashes.

digital display

flashes. Digital O

alarm high

limit is highlighted. Alarm Button flashes.

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

alarm high limit

stays highlighted, Warning Bar still flashes).

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

675-120 Rev. F

40 Infant Flow

SiPAP

Alarm Method of Setting

Low oxygen concentration

5 FiO2 below set point

(< at time alarm is set for 15 seconds, or

20 FiO2 for > 15

< seconds).

High NCPAP pressure (> 3 cmH

O above set point

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.

Indications and Actions

Intermittent high level Audible Alarm.

Warning Bar flashes.

digital display

flashes. Digital O

alarm low

limit is highlighted. Alarm Button flashes.

Intermittent high level Audible Alarm.

Warning Bar flashes. Pressure display

flashes. Digital pressure high

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

alarm low limit

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

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.

Intermittent high level Audible Alarm.

Warning Bar flashes. Pressure display

flashes. Digital pressure low

limit is highlighted. Alarm Button flashes.

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).

675-120 Rev. F

Service Manual 41

Alarm Method of Setting

Over pressure (Patient pressure > 11 cmH

O when in

Always active when power is on.

BiPhasic or BiPhasic Tr mode).

High BiPhasic/ BiPhasic Tr pressure (MAP >

3 cmH2O above set point 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.

Indications and Actions

Intermittent high level Audible Alarm.

Warning Bar flashes.

digital display

flashes. Digital O

alarm low

limit is highlighted. Alarm Button flashes.

Intermittent high level Audible Alarm.

Warning Bar flashes. High MAP pressure

display flashes. Digital high MAP

pressure limit is highlighted.

Alarm Button flashes.

Method of Resetting or Canceling

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

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).

Low battery charge

40%).

Low battery voltage

11.10 V for 5 seconds).

Automatic Battery status indicator

changes from gray to red.

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

Intermittent medium level Audible Alarm.

Warning Bar flashes intermittently.

Battery status indicator flashes.

Unit starts a controlled shut down at a set limit.

Connect external power.

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

675-120 Rev. F

42 Infant Flow

number).

SiPAP

Alarm Method of Setting

Battery fault (Battery disconnected or failing to take or hold charge).

External power disconnected.

Automatic Intermittent high level

Indications and Actions

Audible Alarm. Warning Bar flashes

intermittently. Battery status indicator

flashes. Screen displays

flashing fault code (E number)

Audible Alarm. Warning Bar flashes

intermittently. Battery status indicator

and power indicator alternately flash.

Method of Resetting or Canceling

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

Refer to Service Engineer.

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.

Software fault Automatic Intermittent high level

Audible Alarm. Warning Bar flashes

intermittently. Screen displays

flashing fault code (E number).

Software not running with unit connected to power

Blender whistle Water trap blocked,

Oxygen cell calibration error.

Automatic Constant Audible

Alarm. Warning Bar on. Screen displays

flashing fault code (E

Audible Alarm. Refer to Service full or leaking; filters blocked; loss of wall pressure; imbalance of wall gas supply.

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

Difference between

displayed and set

value.

Cannot be reset. Refer to Service

Engineer.

Cannot be reset. Refer to Service

Engineer.

Calibrate or replace oxygen cell. Refer to Service Manual.

675-120 Rev. F

Service Manual 43

Alarm Method of Setting

Flowmeter fault. Flowmeter fault No flow indications or

Electrical fault. Electrical fault External power light

Low breath rate (Rr = 0 for > timeout as determined by patient trigger module).

breath rate

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

Indications and Actions

flow cannot be adjusted.

does not match screen icon.

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

Refer to Service Engineer.

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.

675-120 Rev. F

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.

44 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 pages 17-18):

• the alarm limits are disabled

• low level calibration procedure for pressure and oxygen 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. With nothing attached to the pressure line inlet port, touch the first key to calibrate at 0 cm H

O. Connect the pressure gauge inline on a patient circuit and connect the circuit to

the unit and the occlude prongs. Adjust the nCPAP Flowmeter until pressure reads 10 cm H

O ±0.2 cm H2O, and touch 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. Set the blender knob at 21% and touch the first key to calibrate at 21 %. Set the blender knob at 100% O

To return to the Diagnostics Menu Screen, touch the

and touch the second key to calibrate at 100 % O2.

button.

Select

to enter a security code.

In order to upgrade features on the unit, a security code must be obtained from CareFusion Technical Support (see Figure 11). After the code is entered, the customer’s unit can be upgraded to different feature sets as laid out by Marketing.

675-120 Rev. F

Service Manual 45

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, press the

675-120 Rev. F

button.

46 Infant Flow

Warning Bar on.

normal mode.

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

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.

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.

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

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

675-120 Rev. F

Service Manual 47

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.

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

and pressure sensors.

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.

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

and pressure sensors.

Replace the pneumatics PCB and recalibrate O

and pressure sensors.

675-120 Rev. F

48 Infant Flow

circuits.

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.

Restricted mode ‘Error number’ alarm prompt.

Corrective Action

Replace the pneumatics PCB and recalibrate O

and pressure sensors.

Replace the pneumatics PCB and recalibrate O

and pressure sensors.

Replace the pneumatics PCB and recalibrate O

and pressure sensors.

Replace the pneumatics PCB and recalibrate O

and pressure sensors.

E50 Oxygen sensor fault (ADC

hits rail).

E51 Oxygen sensor cannot be

calibrated by user (bad offset or high gain).

No oxygen monitor –

oxygen sensor

readings invalid.

No oxygen monitor –

possible fuel cell,

electronic, blender or

gas supply fault.

”E##” displayed; high priority alarm.

Replace the pneumatics PCB and recalibrate O

and pressure sensors / circuits.

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

sensor-

otherwise check the blender ,gas supplies, or

675-120 Rev. F

Service Manual 49

O2 sensor.

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 (oxygen value has been

E54

measured as outside range 18 – 104%)

Oxygen sensor disabled by the operator

E55

No oxygen monitor – oxygen sensor readings unreliable.

Oxygen sensor readings unreliable

No oxygen or alarm monitoring

Software Response

”E##” displayed; high priority alarm.

“E##” alarm displayed.

Corrective Action

Replace the

fuel cell

and recalibrate the

Replace the

fuel cell

and recalibrate the

sensor or

circuits.

Recalibrate

sensor. If

this fails replace the O cell and recalibrate.

Re-power the device to reenable oxygen monitoring.

E61 NCPAP Pres high valve

not connected (via sense).

E62 NCPAP Pres high valve

activation fault (via sense).

E70 PT module fault (PTRDY

or CAN bus failure).

Restricted - BiPhasic/BiPhasic unusable.

Restricted BiPhasic/BiPhasic Tr unusable.

Untriggerable - Apnea and PT unusable.

Restricted mode. ‘Error number’ alarm prompt.

Reduced functionality ‘Error number’ alarm prompt.

Replace the pneumatics PCB and recalibrate the

and

pressure sensor.

Replace the pneumatics PCB and recalibrate the

and

pressure sensor.

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

675-120 Rev. F

50 Infant Flow

alarm prompt.

board/cable.

SiPAP

Error

Code

Fault Condition Consequence

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.

E90* Spurious software

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

E90 Abnormal hardware,

software or watchdog reset.

Untriggerable - Patient

may be in Apnea but

PT module may be

dysfunctional.

Untriggerable – No

BiPhasic Tr treatment

given to patient.

Spurious – software

interrupted and restarts

(possibly during

treatment).

Spurious – software

restarts possibly during

treatment.

Software Response

Reduced functionality ‘Error number’ alarm prompt.

Reduced functionality ‘Error number’

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

Software restarts ‘Error number’ alarm prompt.

Corrective Action

Replace the Patient Trigger board/cable.

Replace the Patient Trigger

Replace the main control PCB and recalibrate O

and pressure sensors.

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

E91 Internal software error

detected.

Unusable – software

unreliable.

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.

675-120 Rev. F

Service Manual 51

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 CareFusion 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.

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

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, moisture and foreign objects. If the unit is not being used for a long period of time, remove the battery.

the unit from the power supply.

numbers on the associated figure.

675-120 Rev. F

52 Infant Flow

blender or Blender Overhaul Kit

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

Water Trap Filter Annually

SiPAP

Pilot Drive Check Valves Annually

Case Bleed Filtered Restrictor Annually

Blender Alarm and Bypass Components (by replacement of

Solenoid Valve (by replacement of Valve/Sensor PCB)

Every Two Years

Every Five Years

675-120 Rev. F

Service Manual 53

Removal and Fitting of Case

Refer to Figure 12.

Removal

1 Remove eight screws (1) on the rear panel and two screws on the case-

bottom.

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 on page 69) 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.

675-120 Rev. F

Figure 12: Case Removal/Fitting

54 Infant Flow

Removal and Fitting of Battery

Refer to Figure 13.

Removal

1 Remove the case.

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 spacer (3). Note position of cable tie securing battery, then cut and remove cable tie.

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

Note

The battery is held in position in the compartment by a tab on the frame and secured by cable tie P/N 461964.

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

recessed hole in the frame and remove the battery.

SiPAP

Note

Exhausted batteries and oxygen fuel cells both contain lead and must be disposed of according to local regulations.

Fitting

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

PCB.

2 Slide the battery into the compartment against the tab (5) and position the

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

3 Install the spacer (3) 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 Install new cable tie securing the battery against the metal tab.

6 Refit the case.

675-120 Rev. F

Service Manual 55

Figure 13: Battery Removal/Fitting

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 Rev. F

Figure 14: Oxygen Filter Removal/Fitting

56 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 the

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 on page 69) and functional

check of the IFSD and calibrate the fuel cell.

SiPAP

Figure 15: Oxygen Filter Restrictor Removal/Fitting

675-120 Rev. F

Service Manual 57

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.

Note

Exhausted batteries and oxygen fuel cells both contain lead and must be disposed of according to local regulations.

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 on page 69) and functional

check of the IFSD and calibrate the fuel cell.

675-120 Rev. F

58 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 PL2 (3) on the Patient Trigger PCB.

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

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

675-120 Rev. F

Service Manual 59

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 pilot drive check valves as follows:

a Note location of cable ties securing the check valve assemblies behind

the flowmeters, then cut and remove the cable ties.

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).

16 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.

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 To replace the blender alarm bypass components, first locate the reed alarm

cap on the blender. This will be located either on the back of the unit to the right of the inlet block or on the inlet gas block itself. Refer to directions in the Blender Service Manual to replace components.

Note

Should the alarm cap not be in either location, contact CareFusion Technical Support.

675-120 Rev. F

60 Infant Flow

SiPAP

Figure 17: Blender and Components Removal/Fitting

675-120 Rev. F

Service Manual 61

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 Hold check valve assembly against cable tie mounts behind flowmeter

and install new cable tie. Repeat for the other check valve assembly.

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).

Note

See Appendix D for the tubing diagram.

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

a Connect the exhaust tubes and the PA flow tube.

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

(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

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 on page 69) and functional

check of the IFSD and calibrate the fuel cell.

15 Install the case.

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

/8 “ silicone tube.

675-120 Rev. F

62 Infant Flow

Removal and Fitting of Water Trap Filter

Refer to Figure 18 and document L2879.

Removal

1 Remove the filter bowl (1) using the water trap tool included with the IFSD (P/N

673-051-A).

2 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 water trap tool.

SiPAP

675-120 Rev. F

Service Manual 63

Removal and Fitting of Case Bleed Filtered Restrictor

Refer to Figure 18 and document L2879.

Removal

1 Remove the case and loosen the clamp securing the restrictor to sheet metal.

2 Note restrictor flow direction, then remove the case bleed filtered restrictor (3)

from the 4mm tube.

3 Discard the case bleed filtered restrictor (3).

Fitting

1 Install the new case bleed filtered restrictor (3) to the tube in the proper

orientation.

2 Re-secure the restrictor to the sheet metal.

3 Install the case.

675-120 Rev. F

Figure 18: Water Trap Filter Removal/Fitting

64 Infant Flow

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 on page 69) and functional

check of the IFSD and calibrate the fuel cell.

SiPAP

675-120 Rev. F

Service Manual 65

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.

CareFusion 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 Rev. F

Power OFF (for part of the equipment)

ETL Mark and Registration Number

66 Infant Flow

connection.

Symbol Source / Compliance Meaning

SiPAP

CareFusion Symbol

CareFusion 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

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

Keep Away from Heat

RS232 Connection

675-120 Rev. F

Service Manual 67

Symbol

Description

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).

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

675-120 Rev. F

68 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

-High, NCPAP Pres high and O

for T cycle is delivered regardless of button press duration

Toggle between Main Screen and Monitored Parameter Screen

Go to user calibration mode screen

%. One breath

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,

675-120 Rev. F

Service Manual 69

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 (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) Flowmeter to about 8 LPM then push the soft key button below the left flowmeter icon (Figure A–1).

Figure A–1

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

6. Set the pressure High Flowmeter to about 2 LPM then push its soft key button under the right flowmeter icon. The Respiratory Sensor option is not required, but to finish, select this soft key button.

675-120 Rev. F

70 Infant Flow

SiPAP

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

Figure A–2

8. The next screen varies but select BiPhasic soft key (Figure A–3).

Figure A–3

675-120 Rev. F

Service Manual 71

9. Accept the default BiPhasic settings by selecting the BiPhasic soft key again

(Figure A–4).

Figure A–4

10. Verify that the measured value on the external oxygen analyzer 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 A–5).

675-120 Rev. F

Figure A–5

72 Infant Flow

SiPAP

Infant Flow

SiPAP™

Model M675

675-120 Rev. F

Service Manual 73

Parameter

Min

Max

Accuracy

Units

± 0.005

0.5

15%

apnea

Appendix B – Product Configurations

Non-US Configuration Parameters

Set Oxygen concentration, %O2 21 100

CPAP flow rate 0 15

Bi-level additional flow rate 0 5

BiPhasic on time, T-High (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

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

1 120

±15%

± 15%

± 0.5

± 1

L/min

seconds

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, T-High (inspiration time)

BiPhasic rate, R (respiration rate) 1 54

Breath rate timeout 10 30

0.1 3.0 *

±3

±15%

± 0.005

± 0.5

L/min

seconds

Seconds

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

DEFAULT SETTINGS

Inspiration Time T-High: 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

675-120 Rev. F

: 20 seconds (+/- 1%)

74 Infant Flow

SiPAP

Infant Flow

Model M675

SiPAP™

675-120 Rev. F

Service Manual 75

Appendix C – Spare Parts

To identify a part referenced in this manual, refer to the associated Figure and Item number in Table 8.

Table 8 - Spare Parts

Figure Item Number Part Name Part Number

13 3 Battery, Packaged 777244

14 3 Filter 06804

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 68289

17 12 O-ring, 7/16” x 9/16” 465476

22 Blender 11329

26 Pilot Drive Check Valves 675-230

18 2 Water Trap Filter Element 467269

3 Case Bleed Filtered Restrictor 467542

Valve/Sensor PCB Assembly, Packaged

777245

675-120 Rev. F

76 Infant Flow

Part Number

Description

467469

FLOWMETER KNOB

467466

WASHER M3 CRINKLE BECU (FOR CASE)

777244

PACKAGED BATTERY, MK3

673-051-A

WATERTRAP TOOL

465474

O-RING, O2 FILTER

52700A

VALVE/SENSOR PCB (PACKAGED ASSEMBLY)

467458

POWER INPUT TWIN FUSE

675-300

EXHAUST TUBE 90 DEGREE

03895

VALVE CHECK DCKBL BLACK

22562

BLENDER KNOB (for blender part number 11798)

Additional Service Parts:

467472 BLENDER CONTROL KNOB (for blender part number 11329)

467468 CAP, BLENDER CONTROL KNOB

467471 POINTER, BLENDER CONTROL KNOB

467470 CAP, FLOWMETER KNOB

675-308 CASE

467467 FOOT, POLYURETHANE .5OD

675-200 FLOWMETER MK3 HIGH

675-201 FLOWMETER MK 3 LOW

09220 FLOWMETER, AUXILIARY

47072 SPACER ROUND M4X155MM NYLON

467595 COMPRESSION PAD

465464 FILTER, WATERTRAP

SiPAP

465476 O-RING, PATIENT CONNECTOR

672-024-SA ASSEMBLY, FILTER

465457 O-RING, O2 SCREW/FLOWMETER/GAS BLOCK

68289 FUEL CELL

675-230 PILOT DRIVE DUCKBILL ASSY

467542 CASE BLEED FILTER RESTRICTOR

675-260 LCD CABLE 12

675-257 LED BOARD CABLE-6

467459 FUSE TIME LAG 2.5A 250V

675-307 AUX FLOW MOUNTING BLOCK

11798 ASSY BIRD BLENDER

10003 MAINT KIT MCRBLNDR+LOFLO

675-101-xxx OPS MAN INF FLOW SiPAP

677-002 TRANSDUCER INTERFACE

467349 ABDOMINAL RESP SENSOR 25PK

06804 FILTER NYLON CONE INL

467269 FILTER ELEMENT (WATERTRAP)

467455 SWITCH COVER

675-120 Rev. F

Service Manual 77

675-310-FR

FRONT PANEL

675-316

MK3 TRIGGER LEUR

777072-101

ASSY O2 /AIR FITTINGS MARK III DISS

461964

CABLE TIE, BATTERY

Part Number Description

675-256

675-310-EN FRONT PANEL

675-310-RO FRONT PANEL

675-312 CONNECTOR PATIENT INLET

675-209 O2 SENSOR CABLE

777072-xxx BLOCK, INLET O2/AIR System

777242-101 SERVICE KIT, Mk3 DRIVER ANNUAL

777242-103 SERVICE KIT, Mk3 DRIVER 5 YEAR

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

52000-00239 CABLE TIE, CHECK VALVE ASSEMBLY

11431 ASSEMBLY, AUXILLIARY FLOWMETER

SWITCH CABLE ASSY

675-120 Rev. F

78 Infant Flow

SiPAP

Infant Flow

SiPAP™

Model M675

675-120 Rev. F

Service Manual 79

Appendix D – Pneumatics Assembly

675-120 Rev. F

80 Infant Flow

SiPAP

675-120 Rev. F

Service Manual 81

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)

RSP Patient’s spontaneous respiratory rate (per minute)

s / sec Seconds

Sigh A single pulse of additional gas flow

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 Rev. F

82 Infant Flow



Term Meaning

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

apnea

/ T

LBR

T-High 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 Rev. F

CareFusion Infant Flow SiPAP M675 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Infant Flow® SiPAP™ Model M675

Revision History

Warranty

Limitation of Liabilities

Contents

Notices

Chapter 1 – Product Description

Chapter 2 – Product Specifications

Chapter 3 – Warnings and Cautions

Chapter 4 – System Construction

Chapter 5 – Operation

Chapter 6 – Operation

Chapter 7 – Maintenance

Chapter 8 – Explanation of Symbols

Appendix A – Oxygen Leak Test

Appendix B – Product Configurations

Appendix C – Spare Parts

Appendix D – Pneumatics Assembly

Glossary