CareFusion Infant Flow LP SiPAP M675 User manual

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Page 1

Infant Flow® LP SiPAP and SiPAP Model M675

Service manual

Page 2

ii Infant Flow

LP SiPAP Model M675

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

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

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

© 2008 – 2011 CareFusion Corporation or one of its subsidiaries. All rights reserved Infant Flow is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are property of their respective owners.

USA

CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887-4668

Authorized European Representative

CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany

800.231.2466 tel +1.714.283.2228 tel +1.714.283.8493 fax

carefusion.com

Literature number: 675–120 Revision G

+49.931.4972.0 tel

+49.931.4972.423 fax

675–120 Rev. G

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Service Manual iii

September 2003

675-120(1)

Release

page 88.

Update list of service parts

Updated Table 6 starting on page 43

Revision History

Date Revision Changes

November 2004 B

December 2004 C

May 2005 D

Release manual in VIASYS Healthcare template using VIASYS Healthcare Respir ator y Care nomenclature.

Revised per EO 27980. Removed the picture from the title page. Deleted the ESD warning from page 19. Removed “O2 Sensor” and added the word “measured” on page 30. Changed “O2 sensor” to “fuel cell” on pages 39, 45, 62, 68, 69, 73, 86, and 87. Replaced the O2 senor row on page 50. Updated the error codes on pages 56 and 57. Replaced the warning on page 61. Changed the Fitting procedure on pages 64, 68, and 75. Changed step 6 on page 65. Added Addendum A – Oxygen Leak Test Changed Transducer Assy. To Transducer Interface on

Revised per ECO 60329 Update address/contact info Update battery remove/install procedure Added note for fuel cell disposal Update check valve assembly remove/install procedure Update water trap & restrictor remove/install procedure Delete redundant leak test

August 2008 E

675-120 Rev. G

Updated company information Updated company information Corrected Table 2 and updated Table 3 Updated Figure 6 Updated Figure 10 Updated the section “Diagnostics.”

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iv Infant Flow

FRONT”

Model M675

Date Revision Changes

April 2010 F Changed Ti to T-High throughout

Figure 5 - Diagnostic screen updated Spelling correction from “GRD” to “GND” Added “Note: transducer must be attached.” Changed “10 V” to “11.10 V” Updated Table 6 - Error Codes (E50 - E54) and added E55 Removed “Blender (Check Valves and Filter) Annually” from table 7. Added “, and two screws on the case-bottom”. Added “and document L2879” Replaced Ti symbol with T-High symbol Changed “PL5” to “PL2” Replaced Figure 3 Replaced Figure 4 and 5. Changed “value doesn’t” to “value on the external oxygen analyzer doesn’t”. Changed “467352” to “68289”; changed “777245” to “52700A”; removed items 677-005A, 675-311, S117635, 467461, 467460. Removed item S117641; changed “675-310” to “M675A-

LP SiPAP Model M675

May 2011 G

Added instructions and specifications for LP SiPAP

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Service Manual v

Warranty

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

The liability of CareFusion, (referred to as the Company) under this warranty is limited to replacing, repairing or issuing credit, at the discretion of the Company, for parts that become defective or fail to meet published specifications during the warranty period; the Company will not be liable under this warranty unless (A) the Company is promptly notified in writing by Buyer upon discovery of defects or failure to meet published specifications; (B) the defective unit or part is returned to the Company, transportation charges prepaid by Buyer; (C) the defective unit or part is received by the Company for adjustment no later than four weeks followin g t he last day of the warranty period; and (D) the Company’s examination of such unit or part shall disclose, to its satisfaction, that such defects or failures have not been caused by misuse, neglect, improper installation, unauthorized repair, alteration or accident.

Any authorization of the Company for repair or alteration by the Buyer must be in writing to prevent voiding the warranty. In no event shall the Company be liable to the Buyer for loss of profits, loss of use, consequential damage or damages of any kind based upon a claim for breach of warranty, other than the purchase price of any defective product covered hereunder.

The Company warranties as herein and above set forth shall not be enlarged, diminished or affected by, and no obligation or liability shall arise or grow out of the rendering of technical advice or service by the Company or its agents in connect ion with the Buyer's order of the products furnished hereunder.

Limitation of Liabilities

This warranty does not cover normal maintenance such as cleaning, adjustment or lubrication and updating of equipment parts. This warranty shall be void and shall not apply if the equipment is used with accessories or parts not manufactured by the Company or authorized for use in writing by the Company or if the equipment is not maintained in accordance with the prescribed schedule of maintenance.

The warranty stated above shall extend for a period of One (1) year fr om date of shipment, with the following exceptions:

1. Components for monitoring of physical variables such as temperature, pressure, or flow are warranted for ninety (90) days from date of receipt.

2. Elastomeric components and other parts or components subject to deterioration, over which the Company has no control, are warranted for sixty (60) days from date of receipt.

3. Internal batteries are warranted for ninety (90) days from the date of receipt.

The foregoing is in lieu of any warranty, expressed or implied, including, without limitation, any warranty of merchantability, except as to title, and can be amended only in writing by a duly authorized representative of the Company.

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vi Infant Flow

LP SiPAP Model M675

Revision History ................................................................................ iii

Warranty ............................................................................................ v

Limitation of Liabilities ........................................................................ v

Notices ............................................................................................ viii

EMC Notice ............................................................................................................... viii

MRI Notice ................................................................................................................. viii

Intended Use Notice ................................................................................................... ix

Regulatory Notice ....................................................................................................... ix

Classification .............................................................................................................. ix

Declaration of Conformity Notice ................................................................................. x

Chapter 1 – Product Description ................................................................................ 1

Chapter 2 – Product Specifications ............................................................................ 3

Modes .......................................................................................................................... 3

Controls ....................................................................................................................... 3

Monitors ....................................................................................................................... 3

Alarms ......................................................................................................................... 4

Pneumatic Supply ........................................................................................................ 4

Electrical Supply .......................................................................................................... 4

Atmospheric & Environmental ...................................................................................... 5

Physical ....................................................................................................................... 5

Chapter 3 – Warnings and Cautions .......................................................................... 7

Terms .......................................................................................................................... 7

Warnings ..................................................................................................................... 7

Cautions ...................................................................................................................... 9

Chapter 4 – System Construction ............................................................................ 11

Touch Screen ............................................................................................................ 15

Alarm Conditions ....................................................................................................... 17

Diagnostic Screen ...................................................................................................... 17

Chapter 5 – Theory of Operation .............................................................................. 19

Gas Flow ................................................................................................................... 19

Electronic Functions .................................................................................................. 22

lectrical Layout ........................................................................................................ 23

Fault Management ..................................................................................................... 24

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Service Manual vii

Chapter 6 – Operational Setup ................................................................................ 25

Preparing and Connecting the Equipment ....................................... 25

Switching On the IFSD .................................................................... 29

User Verification Test ...................................................................... 30

Power-on Check ........................................................................................................ 30

Two Point O

Leak Test ................................................................................................................... 32

Alarms Test ................................................................................................................ 33

Infant Flow

Setting up the Equipment ........................................................................................... 36

Setting the NCPAP Parameters ................................................................................. 37

Setting the BiPhasic Parameters ................................................................................ 38

Setting the Triggered BiPhasic Parameters ................................................................ 39

Calibration .................................................................................................................. 41

Giving a Manual Timed Sigh ...................................................................................... 41

Operation Without Electrical Power ............................................................................ 41

Fault Indications ......................................................................................................... 42

Diagnostics ................................................................................................................ 48

Sensor Calibration ................................................................................ 31

LP SiPAP/SiPAP User Verification Test Checklist .................................. 35

Chapter 7 – Maintenance ......................................................................................... 55

Maintenance Frequencies ................................................................ 55

PM Procedure ............................................................................................................ 55

Tools Required........................................................................................................... 55

Cleaning .......................................................................................... 56

General ...................................................................................................................... 56

Removal and Fitting of Case ...................................................................................... 59

Removal and Fitting of Battery ................................................................................... 60

Removal and Fitting of Oxygen Filter ......................................................................... 61

Removal and Fitting of Fuel Cell Filter/Restrictor ....................................................... 62

Removal and Fitting of the Oxygen Sensor ................................................................ 63

Removal and Fitting of Blender and Components ...................................................... 64

Removal and Fitting of Water Trap Filter .................................................................... 68

Removal of the Pilot Drive Check Valves ................................................................... 68

emoval and Fitting of Case Bleed Filtered Restrictor ............................................... 69

Removal and Fitting of Valve/Sensor PCB ................................................................. 70

Removal and Fitting of the Muffler/Filter ..................................................................... 70

Chapter 8 – Explanation of Symbols ........................................................................ 71

Appendix A – Oxy g en Leak Test.............................................................................. 75

Appendix B – Produc t C on fig ur ati ons ...................................................................... 79

Non-US Configuration Parameters ............................................................................. 79

US Configuration Parameters .................................................................................... 79

Appendix C – Spare Parts ....................................................................................... 81

Appendix D – Pneumatics Assembly ....................................................................... 83

Glossary ................................................................................................................... 85

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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

LP SiPAP Model M675

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.

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Service Manual ix

Intended Use Not ice

The Infant Flow® LP SiPAP system, consisting of a Driver and Generator plus NCPAP Prongs and Masks, is a medical device intended for the provision of Bi-Level CPAP to produce a sigh. This system is for use in Hospital, Hospital Type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

Operators of this equipment and Se rvice En gineers are required to read and thoroughly understand the contents of this manual before using or maintaining the equipment.

This manual is intended for use by a competent, fully qualified Service Engineer. It includes a description of the unit and how it w or ks. It also contains operating and diagnostic procedures and maintenance instructions. For usage of associated equipment, refer to the Manufacturer’s literature.

Regulatory No t ice

Federal law restricts the sale of this device except by or on order of a physician.

Classification

Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1 Protected, and uses type BF applied parts. Equipment is not suitable for use in presence of flammable anesthetics.

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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

LP SiPAP Model M675

EU Notified Body:

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

Manufactured by:

CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887, USA

If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion.

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Service Manual 1

Chapter 1 – Product Description

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

The Infant Flow Comprehensive configuration. The Plus configuration provides NCPAP and time triggered, BiPhasic modes with and without breath-rate monitoring. The Comprehensive configuration offers these features plus patient BiPhasic mode with apnea backup breaths. The Infant Flow standard in all configurations with an LCD touch screen display, pressure time waveform graphics, integrated patient monitoring, alarms for high and low pressure and FiO

and up to 2 hours of backup battery power.

As a result of the unique, patented design, the Infant Flow systems have been proven to provide the most stable CPAP at the lowest work-ofbreathing for patients compared to other devices. The outstanding performance of the Infant Flow expiratory flows. This system has been designed and tested to perform optimally when used only with accessories available from CareFusion. These accessories include circuits and generators, prong and mask patient interfaces and bonnets.

LP SiPAP and SiPAP systems are currently available in the Plus or

LP SiPAP and SiPAP systems come

LP SiPAP and SiPAP

LP SiPAP and SiPAP systems is irrespective of patient demand or

Infant Flow® LP SiPAP and SiPAP Features

The expanded capabilities of the Infant Flow® LP SiPAP and SiPAP, Plus and Comprehensive configurations, allow for applications to a broader range of patients who may otherwise not be candidates for non-invasive respiratory support.

NCPAP. Allows for continuous positive airway pressure based on clinician set pressure. Breath rate monitoring/alarm can be activated in this mode.

BiPhasic. Allows for time triggered pressure assists to be delivered based on clinician set inspiratory time, rate, and pressure criteria. Breath rate monitoring/alarm can be activated in this mode.

BiPhasic tr*. Allows for patient triggered pressure assists to be delivered based on clinician set inspiratory time and pressure criteria. Breath rate monitoring/alarm, and Apnea backup breaths are automatically active in the mode.

Patented Infant Flow

device for the generation of consistent infant nasal CPAP with a low work of breathing. The Infant Flow LP system has a lower driving pressure than other variable-flow devices.

Fully integrated alarms packages. Supply gases failure, High Patient Pressure, Low patient pressure, high and low delivered Oxygen concentration, change from AC to DC power source, low and flat battery charge status and Low breath rate/apnea alarm.

LP Generator. The Infant Flow® LP Generator is a fluidic

Battery Backup. Up to 2 hours of battery backup allows for intra-hospital transport.

Clear indicators are provided for power supply in use (AC or DC), and battery charge level.

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2 Infant Flow

NCPAP

•

NCPAP with breath rate monitoring and alarm

• •

BiPhasic

•

and alarm

• •

BiPhasic tr*

•

Internal Battery

•

Manual Breath

•

Apnea Back up rate

•

Screen lock

•

Prioritization of alarms

•

LP. Refers to the low driving pressure of the Infant Flow LP Generator. The Infant Flow LP SiPAP system is compatible only with the Infant Flow LP Generator. T he prescribed nCPAP level will not be obtained if other variable flow generators are used.

Screen Lock. After 120 seconds of no screen inputs, the screen changes to the Locked Screen to prevent inadvertent changes. Upon activation of a high priority alarm the screen changes to an unlocked state to allow for immediate interventions as required.

Table 1 - Functions and Accessories

Functions & Accessories Plus Comprehensive*

LP SiPAP Model M675

BiPhasic with breath rate monitoring

*Comprehensive configuration not available for sale in the United States

CAUTION!

The Infant Flow® LP SiPAP and SiPAP systems have been designed and tested as complete systems using Infant Flow® accessories. Only accessories approved for use should be used. If in doubt, please contact your local CareFusion representative.

WARNING!

The Infant Flow® LP SiPAP system is compatible only with the Infant Flow LP Generator. The prescribed nCPAP level will not be obtained if other variable flow generators are used.

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Service Manual 3

Chapter 2 – Product Specifications

Modes

• NCPAP

• NCPAP with breath rate monitoring and low rate alarm

• BiPhasic (t im e triggered)

• BiPhasic (t im e triggered) with breath rate monitoring and low rate alarm

• BiPhasic tr (patient triggered ) with breath rate monitoring, low breath rate

alarm, and apnea back up

Controls

• Inspiratory Time (T-High): 0.1-3.0 seconds

• Rate (R): 1-120 (Comprehensive only. The comprehensive configuration is

not available for sale in the United States.)

• Rate (R): 1-54 (Plus only)

• Apnea Inter val (T

• NCPAP/Pres Low flowmeter: 0-15LPM, accuracy +/- 15% of selected output

• NCPAP/Pres High flowmeter: 0-5LPM, accuracy +/- 15% of selected output

• Manual Breath: X 1

• Rate monitoring on/off: NCPAP

• %O

Monitors

• CPAP

• PEEP

• MAP

• PIP

• %O

• I:E r a ti o

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

: 21 - 100% - accuracy +/-3%

• Spontaneous rate (Rs)

• Battery charg e level

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4 Infant Flow

Alarms

• High airway pressure – 3 cmH20 above measured airway pressure

• Hig h cir cuit pressure – maximum 11 cmH20 in time triggered Biphasic mode

• Hig h cir cuit pressure – maximum 15 cmH20 in patient triggered Biphasic tr

mode (Comprehensive only. The comprehensive configuration is not available for sale in the United States.)

• Low airway pressure – 2 cmH20 below measured airway pressure or 1 cmH20 if otherwise would be zero

• Hig h and Low delivered Oxygen concentration +5% of setting

• Low breath r ate alarm

• Low or Flat battery charge level

• Alarm volume (electronic alarms) 70 dBa at 1 meter

Pneumatic Supply

• Patient Gas Outlet: 15 mm standard taper fitting

LP SiPAP Model M675

• Patient Pressure Input: 4.5 mm Luer taper fitting

• Gas Supply: Nominal 4 bar or 60 psi, clean, dry medical air and oxygen

• Range: 2.8 to 6 bar (40 to 90 psi); maximum differential pressure 2 bar

(30 psi)

• Manometer: Range 0 to + 20 cmH

• Gas Connecti ons: Standard DISS or NIST connectors

Electrical Supply

• Input Voltage:100-230 VAC

• Input Frequency: 50/60 Hz

• Power Consumption: 50 VA maximum

• Fuse Rating For 220 V nominal operation: “T” Type 2.5 A at 250 V

• Device Housing Prot ection rating level: IPX1

• Battery Worki ng Time: 2 hours (from fully charged state)

• Battery Charging Time: max. 16 hours

O, accuracy, ± 2% of span

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Service Manual 5

Atmospheric & Environmental

• Temperatur e Range-Operating: 5 – 40° C

• Storage: 0 - 50° C

• Relative Humidit y -Operating: 0 – 90% non-condensing

• Storage: 0 – 90% non-condensing

Physical

• Dimensions (driver only) -(W x H x D) 26 x38 x 23.5 cm /

10.25 x15 x 9.25 in

• Weight (driver only)-8.8 kg / 19.5 lb

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6 Infant Flow

Infant Flow

LP SiPAP an d SiPAP

Model M675

LP SiPAP Model M675

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Service Manual 7

Chapter 3 – Warnings and Cautions

Please review the following safety information before operating the Infant Flow® LP SiPAP or SiPAP system. Attempting to operate this equipment without fully understanding its features and functions may result in unsafe operating conditions.

Warnings and Cautions, which are general to the use of the device under all circumstances, are included in this section. Some Warnings and Cautions are also inserted within the manual where they are most meaningful.

Notes are also located throughout the manual to provide additional information related to specific features.

If you have a question regarding the installation, set up, operation, or maintenance of the device, contact technical support at CareFusion.

Terms

WARNINGS identify conditions or practices that could result in serious adverse

reactions or potential safety hazards.

CAUTIONS identify conditions or practices that could result in damage to the

ventilator or other equipment.

NOTES identify supplemental information to help you better understand how

Warnings

• Whenever a patient is attached to respiratory care equipment, constant

attendance is required by qualified personnel. The use of an alarm or monitoring system does not give absolute assurance of warning for every malfunction that may occur in the system. In addition, some problems may require immediate attention.

• The gas blender incorporated in this product is designed to mix medical

grade air and oxygen only. Do not modify the inlets to accommodate other source gases such as anesthetic gases.

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

use.

• Liquid water or other contaminants in either gas supply, particularly the air

supply, may cause malfunction of this equipment and equipment connected to it.

• When f illing a humidifier, do not move the stand. Moving or transporting the

stand while refilling may cause the stand and equipment to over balance.

the ventilator works.

• The Infant Flow LP SiPAP system is compatible only with the Infant Flow LP

675-120 Rev. G

Generator. The prescribed nCPAP level will not be obtained if other variable flow g ener ators are used.

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8 Infant Flow

• Do not use conductive patient circuits with the Infant Flow® LP SiPAP Driver.

• Nasal CPAP can cause nasal irritation, septal distortion, skin irritation and

pressure necrosis. Observe the usage guidelines to minimize these complications.

LP SiPAP Model M675

• 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 extr eme conditions (minimum supply pressure and maximum gas demand, including auxiliary output) output flow rates and delivered pressure may be reduced.

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

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

• The

indicates a connection between the transducer interface and the unit. It does not indicate correct positioning of the Abdominal Respiratory Sensor.

• Calibration m ust only be done when the unit is not connected to the patient.

• Verif y that the displayed value for delivered FiO

corresponds to the value set

on the blender. Refer to Faults and Indications.

• Oxygen vigor ously accelerates combustion. To avoid explosion hazard, do not use any instrument or other equipment that may have been exposed to oil or grease contamination.

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Service Manual 9

Cautions

• Federal Law (USA) restricts this device to sale by or on the order of a

physician.

• The precision gas blender in this product may become non-functional or

damaged if used without the protective water trap and filters provided.

• The power switch on this unit does not isolate the external power supply.

Disconnect the power supply cable to ensure complete isolation.

• Before use, verif y that this equipment has been authorized for use by a

qualified person.

• The Infant Flow

tested as complete systems using Infant Flow accessories approved for use should be used. If in doubt, please contact your local CareFusion representative.

• Where the integrit y of the external protective earth conductor is in doubt, the

equipment shall be powered by its internal power source (battery).

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

LP SiPAP and SiPAP systems have been designed and

SiPAP accessories. Only

• Ensure patient breathing circuit is replaced at regular intervals.

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10 Infant Flow

Infant Flow

LP SiPAP and SiPAP

Model M675

LP SiPAP Model M675

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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

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12 Infant Flow

LP SiPAP Model M675

Figure 1: IFSD Front Panel

Gas Module

The function of the gas module is to take air and oxygen, blend them into the required mixture and deliver this mixture to the patient at the prescribed flow rat e. The gas module also measures the oxygen concentration, measures the patient pressure, provides an auxiliary gas outlet (optional) and provides switched Biphasic flow.

The main components are an air/oxygen blender, a flow manifold, a vent valve, an exhaust manifold with alarm whistle, NCPAP Pres low and NCPAP Pres high flowmeters, and a valve/sensor PCB. The inlet gas connections are on an interc han geable i nlet bl ock to allow for different gas fittings. The exhaust manifold discharges gas to the outside of the case and is positioned away from the electrical connectors and switch to reduce any potential explosive hazard.

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Service Manual 13

Leak Test

Electronics Module

The function of the electronics module is to power the unit either by AC mains supply or DC emergency battery supply, to control the gas module and read the gas module sensors. The main components are a power supply unit, a rechargeable batt ery, a main processor PCB, LED PCB, Valve/Sensor PCB and a LCD screen (touch screen). The LCD screen includes a back-light which is always on when the IFSD is powered. The touch screen displays information and receives inputs from the Operator via the touch screen keyboard.

Figure 2: IFSD Back Panel

Port

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14 Infant Flow

LP SiPAP Model M675

Figure 3: IFSD Internal Components

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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 (P lus and Comprehensive Models)

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

Firmware Module

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

Touch Screen

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

flashes red to indicate an alarm.

Battery Status and Chargi ng Indicator

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

Alarm Button

The alarm button alerts the Operator to fault conditions. An audible alarm is activated at the same time. In the unalarmed condition the button is green high-priority alarm condition, the button flashes

heard. If the alarm button is pressed (to silence the audible alarm), the button changes to flashes condition, the button is solid

675-120 Rev. G

. In the

red and an audible alarm is

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

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

yellow with an audible alarm. If any alarm

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16 Infant Flow

condition resets itself, the yellow alarm bar remains to alert the clinician of a previous problem.

Caution/Information

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

Mode Indicator

The Mode Indicator shows four question marks when in Start up or Adjust and changes to show the applicable mode in use (e.g. NCPAP).

LP SiPAP Model M675

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

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Service Manual 17

Alarm Conditions

Audible and visible alarm indications are given to alert the Operator to specified conditions that affect the operation of the unit. The electronic alarm limits are automatically set after two minutes without Operator inputs but the Operator can manually set the alarm parameters for certain conditions if required. The IFSD has the following alarms:

• an audible W histle which sounds a constant tone when the gas imbalance

limits are exceeded.

• an audible Alarm which sounds a constant tone or two different intermittent

tones; medium or high level (medium level sounds beep.beep.beep every 15 seconds and high level sounds beep .beep .beep beep beep every 10 seconds).

• a visual Warning Bar which flashes red continuously, flashes intermittently or

comes on continuously.

• an Al arm Button on the touch screen status bar which flashes continuously.

Other indications are given to indicate the status of the condition. Refer to Table 2 for alarms and indications for specified conditions.

Diagnostic Screen

A diagnostic screen is provided for low level calibration, test procedures for valves and an error log. Figure 5 shows the screen display. Labeling of Diagnostic screen

will be the same regardless of configuration.

Figure 5: Diagnostic Screen

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18 Infant Flow

Box

Description

PCB. Position 1 is on and 0 is off.

INDICATOR

contrast.

successfully completed and a if the calibration fails.

Box

Description

S/W

The S/W box shows the version and serial number of the loaded firmware.

(E2P).

The PT box shows the status of the Patient Trigger module.

inspiratory time, and breath rate (controlled by DIP 1).

(BLL) and if the backlight is operative (BLF - 1 for fail, O for on).

(BAT), the battery charge status (CHG) and the temperature (TMP).

8.2 and 10 V).

RS232

The RS232 box shows factory set data.

values.

(OSEN) and the software offset (OFFS) and gain (GAI N) values.

for the zero valve and the Z sensor (ZSEN) voltage.

for the dump valve and the D sensor (DSEN) voltage.

for the pressure assist valve and the P sensor (PSEN) voltage.

Table 2 - Diagnostics Screen Boxes

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

LP SiPAP Model M675

CONTRAST

CALIBRATION INDICATOR

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

The calibration indicator box shows

during calibration, a when

The following display boxes show if the values are within t he set parameters, a

if the values are outside the set parameters, a if the function is not

calibrated and a

if the function is disabled on the DIP switch.

Table 3 - Additional Diagnostics Screen Boxes

H/W The H/W box shows the status of the watchdog t i mer (WDG) and the EEPROM

CONFIG The CONFIG box shows the softw are con figurati on based on the DIP swit ch

settings and requirements. LAB = INTL or US (controlled by DIP 3), which is the Comprehensive or Plus model; tBiP = 1 or 0 (controlled by DIP 2 and 5), which indicates Triggered BiPhasic is enabled (1) or disabled (2); APB = 1 or 0 (controlled by D IP 2 ), w hi ch in dicates that Apnea BiPhasic is enabled (1) or disabled (0 ); The re maining sy mbols provi de the de fault and r ange s for

LCD The LCD box shows the ambient light sensor voltage (AMB), the back light level

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

RAILS The RAILS box shows the ground voltage (GND), and the control voltages (6.5,

PRESSURE The PRESSURE box shows cm H2O pressure value, the voltage from the

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

OXYGEN The OXYGEN box shows the FiO2 %, the voltage from the oxygen sensor

ZVALVE The ZVALVE box shows if the Z DRIVE is operative (ZDRV - 1 for fail, O for on)

DVALVE The DVALVE box shows if the D DRIVE is operative (DDRV - 1 for fail, O for on)

PVALVE The PVALVE box shows if the P DRIVE is operative (PDRV - 1 for fail, O for on)

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Service Manual 19

Chapter 5 – Theory of Operation

Gas Flow

With the oxygen and air connections connected and the power switch ed on, oxygen and air at 386 kPa (56 psig) flows to the blender. The air passes thr ough a water trap with an integral filter where any moisture in the air is removed. Oxygen and air are filtered before entering a non-return valve in the blender. The blender mixes the oxygen and air in the proportion set by the position of the FiO blender supplies blended gas between 2.5 and 30 LPM.

The blender incorporates an alarm/bypass module. If a single gas supply fails or there is an imbalance between the inlet gas pressures exceeding 200 kPa (30 psig), the module directs the flow through a reed whistle to warn the Operator of the condition and at the same time connects the inlet gas at the hig her pressure to the blender outlet.

The blended gas is filtered before passing through a flow control to an oxygen analyzer. The oxygen analyzer utilizes a galvanic fuel cell to measure and display the measured delivered oxygen concentration.

control valve. The

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

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

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

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20 Infant Flow

LP SiPAP Model M675

Figure 6: IFSD Gas Flow Schematic

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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 (Opti ona l)

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 LPM 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 Pr es 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 w hen 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 E lectrical Power

The IF SD 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 In this mode, visual indications and warnings are not given except for the gas failure alarm.

level.

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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.

LP SiPAP Model M675

Figure 7: IFSD Electronic Enclosure

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Service Manual 23

Electrical Layo ut

Figure 8 shows the electrical wiring and PCB connector layout.

Figure 8: IFSD Electrical Wiring Diagram

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24 Infant Flow

BiPhasic

Fault lockout

Unit inoperable by

Error code(s)

alternates

Unit restricted to Error code(s)

Patient trigger

Battery status

Unit will not

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

LP SiPAP Model M675

Alarm Functionality FiO2 CmH2O NCPAP

screen shows error code(s).

shown on mode selection screen. Status bar mode

software, operable in unpowered

NCPAP and NCPAP+Apnea modes.

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

X X X X X X

   

  

NCPAP+

Apnea

+ Apnea

X X



675-120 Rev. G

shows discharged battery.

operate on battery power when external power supply is removed.

     

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Service Manual 25

Chapter 6 – Operational Setup

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

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 If desired, connect the transducer module to the sensor and to the IFSD.

WARNING!

The Infant Flow LP SiPAP system is compatible only with the Infant Flow LP Generator. The prescribed nCPAP level will not be obtained if other variable generators are used.

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26 Infant Flow

Infant Flow® LP Generator

Infant Flow® LP

LP SiPAP Model M675

SiPAP Driver or SiPAP Driver

Figure 9: Patient Connections

675-120 Rev. G

or Generator

WARNING!

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

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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 IFSD’s ability to provide superior NCPAP. The IFSD is subject to a direct relationship between controlled enriched gas flow and NCPAP pressure.

Nomograms illustrating the relationship between constant airway pressure and flow settings are shown in Figure 10 and Figure 11. Example: 8 LPM gas flow provides 5 cm H

O NCPAP.

Verify the type of IFSD you are using, LP SiPAP or 675–CFG–XXX, to determine which nomogram to use.

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

Figure 10: Flow Pressure Nomogram for 675-CFG-XXX

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28 Infant Flow

performance.

Flow Pressure Nomogram (for reference only) to show typical flow pressure relationships. This is not meant to establish actual product

LP SiPAP Model M675

Figure 11 – Flow Pressure Nomogram for LP SiPAP

Individual devices have a tolerance of up to ±15 percent from that illustr ated in the nomogram and, in particular, at pressures below 2cmH

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Service Manual 29

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 (prog r am memory fault, power supply not connected or emergency battery voltage low), the screen remains black and the warning bar stays on.

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

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

• the screen image is shown in negative

• the warning bar comes on for one second

• the Apnea light comes on for one second

• the audible alarm sounds for one second

• the dump valve is tested

• the pressu r e 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 41.

Note:

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

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30 Infant Flow

User Verification Test

WARNING!

Do not attach the Infa nt Flow® LP Generator or the I nfant Flow® Generator to the patient until User Verification and initial setup into NCPAP mode is complete.

CAUTION!

Although failure of any of the above tests will not prevent the ventilator from functioning, it should be checked to make sure it is operating correctly before use on a patient.

Power-on Check

This test is run automatically on power up of the driver and automatically performs the following checks:

• Flash ROM

LP SiPAP Model M675

• Hardware Input s/Out puts

• Audible and visual alarms indicators

• Test and calibrat ion of pressure sensor

• Test of dump val ve

The unit carries out a full functional check during this time. If unsuccessful, the screen remains darkened and the warning bar remains on. In this case, check for the following;

• Power Supply not connected

• Battery voltage low

If the checks are successful, the screen changes to Power Up Screen. After two seconds, the screen changes to Power Up Check Screen.

During the Power Up check:

• Screen image shown in negative

• Warning bar comes on for one second

• Transducer Assembly LED comes on for one second

• Audible alarm sounds for one second

• Dump valve is tested

• Pressure is set to zero

After two seconds screen changes to Set Up Screen. Alarm limits are disabled and a flashing question mark appears under the NCPAP / Pres Low flowmeter screen indicator.

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Service Manual 31

Two Point O2 Sensor Calibratio n

1. Enter the Calibration Screen from the Setup Screen by pressing the calibration

button on the lower right hand corner of the touch screen.

2. Ensure there is a min i mum 8 LPM set on the NCPAP/PRES Low Flowmeter. In

addition, ensure there is a minimum of 3 LPM set on the NCPAP/High Flowmeter.

3. Adjust the %O

calibration by touching the associated flashing button.

4. Adjust the %O

touching the associated flashing button.

5. Return to the Start up Screen by pressing the Exit button.

control to 21%. Allow the %O2 display to stabilize. Confirm the

control to 100%. Allow the %O2 display to stabilize. Confirm by

Note:

If O2 calibration fails, a red “X” is shown.

If the internal oxygen cell is depleted or damaged, it may not be possible to calibrate the O button. This will disable oxygen monitoring and the audible oxyg en alarms unt il the device is powered off. Whenever the device is operating with oxygen monitor and alarms disabled, a fault code E55 displays, and measured FiO

sensor. The internal oxygen monitor may be disabled using the Disable O2

displays as dashes.

WARNING!

When the Infant Flow® LP SiPAP system unit or SiPAP system unit (part number 675-CFG-xxx) is connected to a patient and the internal oxygen

monitor is disabled, the Infant Flow® LP SiPAP system unit or SiPAP system unit must be used with an external oxygen monitor.

If calibration is attempted, and fails, or if the oxygen cell fails while the device is in normal use, a Fault Code E55 displays, as tabulated in appendix D, and a high priority alarm is indicated visually and audibly. To enable continued operation, the internal oxygen monitoring may be disabled by pressing and holding the alarm mute / reset button for three seconds. This disables the internal oxygen monitor and alarms and clears the alarm condition. The E55 code remains to indicate that the oxygen monitor is inoperative. An external oxygen monitor must be used.

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32 Infant Flow

Leak Test

1. Have the patient circuit and generator assembled as shown in Figure 3.

2. Connect the patient interface (prong or mask) to the generator (see Chapter 5, Step by Step Fixation) and occlude the opening to the patient.

3. If not powered up already, switch on the power to the driver.

4. For LP SiPAP, adjust the NCPAP/Pres Low Flowmeter to 9 LPM. Verify that the measured pressure is 5 ±1 cmH confirm.

For SiPAP, part number 675-CFG-XXX, adjust the NCPAP/Pres Low Flowmeter to 8 LPM. Verify that the measured pressure is 5 ±1 cmH associated flashing screen icon to confirm.

O. Touch the associated flashing screen icon to

LP SiPAP Model M675

O. Touch the

5. Adjust %O

control as prescribed for the current patient. Verify that the blender

setting and the measured oxygen value are within 3%. Touch the associated flashing screen icon to confirm.

6. Adjust the Pres High Flowmeter as prescribed for the current patient. Touch the associated flashing screen icon to confirm.

7. If desired, connect the Transducer Interface to the front panel of the driver if breath monitoring is required during treatment. Touch the associated flashing screen icon to confirm.

8. The display screen changes to the Alarm Set/Confirm Screen. Press the NCPAP button or Alarm Mute/Reset button to set alarms and begin monitoring.

9. Monitored parameter for CPAP should be 4-5 cmH

O. If not, check circuit for

leaks or blockages, (including the humidification system).

10. Remove the occlusion to the patient interface. The monitored CPAP display should be 0-2 cmH

O. If not, check that the interface is not still occluded.

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Service Manual 33

Alarm Test Initial Settings

Air Supply Pressure

Supply Pressure

Patient Circuit

Generator

Infant Flow® LP Generator

8 LPM for SiPAP

% O2

Pres High Flowmeter

Mode

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.

> 30 psig (2.1 bar) > 30 psig (2.1 bar)

Infant Flow® LP Patient Circuit

NCPAP / Pres Low Flowmeter

9 LPM for LP SiPAP or

30% 3 LPM NCPAP

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

1. Make appropriate connections for air and O

gas supply. Connect power cord 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 Flowmeter to 11 LPM. Verify that the high airway pressure alarm activates. Return the NCPAP / Pres Low Flowmeter to 9 LPM for LP SiPAP or 8 LPM for SiPAP and press the Alarm Mute / Silence button for 3 seconds to reset the alarms.

5. High %O activates. Return the O

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

control setting to 30%. Reset alarms by pressing the

Alarm Mute / Reset button for 3 seconds.

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34 Infant Flow

6. Low % O2 Alarm: Adjust the % O2 control to 25%. Verify that the Low %O2 alarm activates. Return the O

control setting to 30%. Reset alarms by pressing the

Alarm Mute / Reset button for 3 seconds.

7. Loss AC Alarm: Disconnect the AC power cor d 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 increasing the NCPAP/PRES Low Flowmeter. Verify that the High Circuit pressure alarm activates. Return NCPAP/PRES Low Flowmeter to 8 LPM and press the Alarm Mute/Silence button for three seconds to reset the alarms.

Note:

If staff is using a transducer (P/N 677-002) for Apnea Monitoring, proceed to step 9. If staff is not using a transducer, mark N/A on checkout sheet and testing is finished.

9. Low Breath Rate (Apnea) Alarm: Attach the transducer and abdominal sensor to the unit. Set Mode to BiPhasic+Apnea/LBR (U.S. Configuration) or Biphasic + LBR, rate 30 Bpm, T-High 0.3 seconds and Tapnea or TLBR to 20 sec. Manually squeeze the abdominal sensor to simulate a spontaneous breath. No alarms should be active. Change the mandatory rate control to setting for rate to 1 Bpm and stop squeezing the abdominal sensor. 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.

LP SiPAP Model M675

O by

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Service Manual 35

TEST

PASS

FAIL

N/A

Automated Tests

Power On Check

Manual Tests

Two Point O2 Sensor Calibration

Patient Circuit Leak test

Manual Alarms Checks

Low Airway Pressure Alarm

High Airway Pressure Alarm

High O

Alarm

Low O

Alarm

Loss AC Alarm

High Circuit Pressure A larm

Low Breath Rate (Apnea) Alarm

Infant Flow® LP SiPAP/SiPAP User Verification Test Checklist

Driver Serial Number:_____________________ Test Date:_________________

Signature of tester:_______________________________________________

Title___________________________________________________________

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36 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

LP SiPAP Model M675

done, 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 f or 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.

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Service Manual 37

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

• The alarm limits are set.

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

Note:

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

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

• The key pad is locked.

• The display remains as shown for patient monitoring.

Touch the

• The display returns to the Mode Selection Screen.

button for three seconds to unlock the key pad.

Note:

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

Setting the NCPAP Parameters

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

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

• The patient respiration rate (Rsp).

• The delay time for the alarm to come on Tapnea.

• The Inspiratory time for a manual sigh.

Use the

buttons to set the alarm delay time.

button.

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

Touch the

• The display changes to the Parameter Adjust Screen.

675-120 Rev. G

button. When the settings have

button to unlock the key pad.

Page 48

38 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 BiPh asic Parameters

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

LP SiPAP Model M675

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. G

-High and Rate can now be adjusted.

button.

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Service Manual 39

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 Trigg er ed 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. G

-High, Rb and

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

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40 Infant Flow

To adjust the parameters, touch the button. The screen changes to the BIPHASIC TR Adjust Screen.

LP SiPAP Model M675

Parameters T

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

-High, Rb and Tapnea can now be adjusted.

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.

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Service Manual 41

Calibration

WARNING!

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

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

• The alarm limits are disabled. Turn the FiO Turn the FiO

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 whi ch wi ll operate un til pressures are b alanced.

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

675-120 Rev. G

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42 Infant Flow

Fault Indications

Refer to Table 1 (all models) and Table 2 (BiPhasic and BiPhasic T r 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

LP SiPAP Model M675

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

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

without electrical power.

• The related fault code numbers are shown on the screen.

• 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 r elease 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. G

Page 53

Service Manual 43

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 lim it 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).

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Page 54

44 Infant Flow

LP SiPAP Model M675

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).

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Service Manual 45

Alarm Method of Setting

Over pressure (Patient pressure > 11 cmH

O when in

Always active when power is on.

BiPhasic or BiPhas ic 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. G

Page 56

46 Infant Flow

number).

LP SiPAP Model M675

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 whist le 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.

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Service Manual 47

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. G

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.

Page 58

48 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.

Press to carry out a pressure calibration The diagnostic main screen stays the same and the key pad at the bottom of the

screen changes. With n othing attached to the pressure line inlet port, touch the first key to calibr ate at 0 cm H and connect the circuit to the unit and the occlude prongs. Adjust the nCPAP Flowmeter until pressure reads 10 cm H gauge, and touch the second key to calibrate at 10 cm H

O. Connect the pressure gauge inline on a patient circuit

O ±0.2 cm H2Oon the external pressure

LP SiPAP Model M675

To return to the Diagnostics Menu Screen, touch the

button.

Press

to carry out an oxygen calibration

The diagnostic main screen stays the same and the key pad at the bottom of the screen changes. Set the blender knob at 21% and touch the first key to calibrate at 21 %. Set the blender knob at 100% O 100 % O

To return to the Diagnostics Menu Screen, touch the

and touch the second key to calibrate at

button.

is currently inactive..

Press to carry out a valve test The diagnostic main screen stays the same and the key pad at the bottom of the

screen changes. Touch the first key to test the zero valve and listen for click of valve, the second key to test the dump valve and listen for click of the valve, and the third key to test the PA valve and listen for the click of the valve.

To return to the Diagnostics Menu Screen, touch the

675-120 Rev. G

button.

Page 59

Service Manual 49

Code

Warning Bar on.

power applied.

power).

assistance.

Press to carry out a user interface test. 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 Press the

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

Error

- Program memory

Fault Condition Consequence

checksum error.

button to show the Error Log Screen

button.

Table 6 - Error Codes

Unusable – Software corrupt, execution inhibited.

button.

Software Response

Hardware held in permanent reset condition with

button.

Corrective Action

Reload software.

- Battery too discharged (<6.5 V) to operate LCD, analogue and valve driver circuits (no external power).

- Battery too discharged (<10 V) to operate analogue and valve driver circuits but sufficient for LCD driver (no external

E10 Non-volatile memory fault. Unusable - unable to

675-120 Rev. G

Unusable - no user interface display.

Unusable – sensor readings invalid.

retrieve/set unit configuration and calibration data.

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

User lockout ‘Plug in external power’ prompt

User lockout ‘Error number’ prompt.

Plug in external power.

Call CareFusion technical support for

Page 60

50 Infant Flow

Code

sensors.

normal mode.

prompt.

alarm prompt.

support.

support

LP SiPAP Model M675

Error

Fault Condition Consequence

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.

Software Response

User lockout ‘Error number’ prompt.

Corrective Action

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

and pressure

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

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.

Battery fault icon flashes and ‘Error number’ alarm

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

User lockout ‘Error number’ prompt.

Replace the battery.

Contact CareFusion technical support.

Contact CareFusion technical

675-120 Rev. G

Page 61

Service Manual 51

Code

support.

sensors.

Error

Fault Condition Consequence

E24 Hardware safe-start

watchdog disabled.

E30 Pressure sensor fault

(ADC hits rail).

E31 Zero valve not connected

(via sense).

E32 Zero valve activation fault

(via sense).

Unusable – valve disabled.

Unusable – pressure sensor readings invalid.

Unusable – pressure sensor readings unreliable.

Software Response

User lockout ‘Error number’ prompt.

Corrective Action

Power cycle unit. If fault still occurs, Contact CareFusion technical

Replace the Valve/Sensor PCB and recalibrate O

and pressure

Replace the Valve/Sensor PCB and recalibrate O

and pressure

Replace the Valve/Sensor PCB and recalibrate O

and pressure

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.

Restricted - no over pressure protection.

User lockout ‘Error number’ prompt.

Restricted mode ‘Error number’ alarm prompt.

Replace the Valve/Sensor PCB and recalibrate O

and pressure

Replace the Valve/Sensor PCB and recalibrate O

and pressure sensors.

Replace the Valve/Sensor PCB and recalibrate O

and pressure

675-120 Rev. G

Page 62

52 Infant Flow

Code

sensors

circuits.

O2 sensor.

circuits.

calibrate.

LP SiPAP Model M675

Error

Fault Condition Consequence

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.

Software Response

”E50” displayed; high priority alarm.

”E51 displayed; high priority alarm.

Corrective Action

Replace the O2 Sensor and recalibrate O

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

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

”E52” displayed; high priority alarm.

”E53 displayed; high priority alarm.

”E54 displayed; high priority alarm.

“E55” alarm displayed.

Replace the

fuel cell

and recalibrate the

Replace the

fuel cell

and recalibrate the

sensor or

Recalibrate

sensor. If

this fails replace the O cell and re-

Re-power the device to reenable oxygen monitoring.

675-120 Rev. G

Page 63

Service Manual 53

Code

sensor.

connected.

Apnea.

dysfunctional.

alarm prompt.

support

alarm prompt.

support

Error

Fault Condition Consequence

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.

Software Response

Restricted mode. ‘Error number’ alarm prompt.

Reduced functionality ‘Error number’ alarm prompt.

Corrective Action

Replace the Valve/Sensor PCB and recalibrate the

and

pressure

Replace the Valve/Sensor PCB and recalibrate the

and

pressure

Check the Patient Trigger interface module/cables are correctly

E71 No breath signal from PT

module although CAN data does not report

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.

E91 Internal software error

detected.

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

Untriggerable – No BiPhasic Tr treatment given to patient.

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

Spurious – software restarts possibly during treatment.

Unusable – software unreliable.

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.

User lockout ‘Error number’ prompt.

Contact CareFusion technical

Contact CareFusion technical support.

Contact CareFusion technical

675-120 Rev. G

Page 64

54 Infant Flow

Code

support

LP SiPAP Model M675

Error

E99 Unknown error detected. Unusable – software

* - Generated as a c onsequenc e of the fault.

Fault Condition Consequence

unreliable.

Software Response

User lockout ‘Error number’ prompt.

Corrective Action

Contact CareFusion technical

675-120 Rev. G

Page 65

Service Manual 55

Chapter 7 – Maintenance Maintenance Frequencies

There are three different types of Preventative Maintenances required for the LP SiPAP/SiPAP system.

1. Annual PM- Placement of annual PM Kit, P/N 777242-101 in unit. Contents include: battery, O2 sensor, various filters and O-rings.

2. Two Year PM- Placement of annual PM Kit and blender overhaul. Annual PM Kit and Low Flow MicroBlender Overhaul Kit P/N 10003 required.

3. Five Year PM- Placement Five Year PM Kit, P/N 777242-103. Contents include: annual PM kit and Valve/Sensor PCB.

PM Procedure

1. Replacement of designated parts

2. User Verification Test (UVT)

3. Oxygen Leak Test

Tools Required

• #1 Phillips Screwdriver

• #2 Phillips Screwdriver

• Flathead Screwdriver

• Pliers

• Circle Plie r s

• If unit has blender knob P/N 22562, blender knob removal tool P/N 93244

• If unit has blender knob P/N467472, 5/16 nut driver

675-120 Rev. G

Page 66

56 Infant Flow

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 Spray cleaning solution onto a cloth, and then wipe the exterior of the unit. DO

NOT spray the solution directly onto the driver, because liquid may get inside the unit and cause damage .Make sure that cleaning agents do not enter the unit through patient connection ports.

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.

LP SiPAP Model M675

General

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

unit.

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

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

3 Technical Assistance can be obtained from the offices listed at the beg inning of

this manual.

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

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.

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

the unit from the power supply. 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 numbers

on the associated figure.

675-120 Rev. G

Page 67

Service Manual 57

Number

777244

Battery

06804

Oxygen Filter

465474

Banjo Screw O-Ring

465457

68289

O2 Sensor

465476

O-Ring on Front Panel

64 – 65, Steps 1 – 12

467269

Water Trap Filter

675-230

Pilot Drive Check Valves

Restrictor

11507

Muffler Filter

Table 7 shows the part numbers, components and page reference for removal directions for the annual pm kit.

Table 7- Annual PM Kit Components

Part Number Components

672-024-SA

465474

Fuel Cell Filter/Restr ictor

and O-rings

467542 Case Bleed Filtered

Removal Directions Page

675-120 Rev. G

Page 68

58 Infant Flow

Number

11329 or 11798

Blender

64 – 67

Overhaul Kit

Service Manual

777242-101

Annual PM Kit

See Table 7

Number

777242-101

Annual PM Kit

See Table 7

52700A

Valve/Sensor PCB

Table 8 shows the two year pm components and page number references.

Table 8- Two Year PM Components

Part Number Component

Removal Direction Page

LP SiPAP Model M675

10003 Low Flow MicroBlender

Table 9 shows the fiver year PM components and page number references.

Table 9- Five Year PM Components

Part Number Component

L1130 Low Flow MicroBlender

Removal Direction Page

675-120 Rev. G

Page 69

Service Manual 59

Removal and Fitting of Case

Refer to Figure 12.

Removal

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

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 75) 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.

Figure 12: Case Removal/Fitting

675-120 Rev. G

Page 70

60 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.

5. Disconnect the positive and negative leads from the battery. Make note of where each lead goes.

LP SiPAP Model M675

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. Reconnect positive and negative leads to battery.

CAUTION!

Verify that the leads are connected correctly. If leads are connected incorrectl y , damag e to the system will result.

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

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

4 Install the spacer (3) and secure in position with the screw (2). Tighten the

screw (2).

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

Processor PCB.

6 Install new cable tie securing the battery against the metal tab.

675-120 Rev. G

Page 71

Service Manual 61

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 (P/N 465476) (4) on the banjo screw (1). 2 Install a new filter (P/N 467464) (3) in the air/oxygen mounting block and install

the banjo screw (1).

3 Tighten the banjo screw (1).

Figure 14: Oxygen Filter Removal/Fitting

675-120 Rev. G

Page 72

62 Infant Flow

LP SiPAP Model M675

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

Install a new O-ring (P/N 465474) (5) on the oxygen filter screw (1). Install a new Oring (P/N 465457) (4) and the filter/ restrictor (P/N 672-024-SA) (3) into the flow mixer block (2). Install the oxygen filter screw (1) and tighten.

Figure 15: Oxygen Filter Restrictor Removal/Fitting

675-120 Rev. G

Page 73

Service Manual 63

Removal and Fitting of the Oxygen Sensor

Refer to Figure 16.

Removal

1 Remove the case. 2 Disconnect the connector SK12 (1) from the top of the oxygen sensor. 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 oxygen sensor (4) from the flow mixer block (5).

Note:

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

5 Discard the oxygen sensor (4) and attached O-ring.

Note:

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

Fitting

1 Check the expiration date of the new sensor. Remove the O2 Sensor (P/N

68289) from the sealed package and check that the fuel cell has an O-ring

installed above the threads. 2 Screw the sensor (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 Connect the connector SK12 (1) to the sensor.

675-120 Rev. G

Page 74

64 Infant Flow

Figure 16: Fuel Cell Removal/Fitting

LP SiPAP Model M675

Removal and Fitting of Blender and Components

Refer to Figure 17.

Note:

Two different blenders are used in the LP SiPAP, P/N 11329 and 11798. These blenders are NOT interchangeable. Contact CareFusion technical support for further assistance.

Removal

1 Remove the case. 2 Remove the battery. 3 Disconnect the connector SK1 (1) on the LED PCB. 4 Disconnect the connector PL5 (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.

/8 “ silicone

Note:

There are trwo types of blender knobs used on the LP SiPAP. P/N 467472 has a removable front cap and the knob can be removed with a 5/16 Nut driver. PN 22562 requires the blender knob removal tool, P/N 93244.

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7 For blender knob P/N 467472, remove the cover (6) from the front of the FiO2

control knob (7). Using the 5/16 nut driver, unscrew the collet on the front of the

FiO

control knob (7), remove the collet and pull off the control knob (7).

For blender knob P/N 22562, use the blender knob removal tool, P/N 93244, to

remove the blender knob. 8 Remove 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. 9 Using a screwdriver or Circle pliers, unscrew the central securing nuts for the

flowmeter knobs and pull off the control knobs (9). 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) from the Pop Off valve on the Front Panel.

Replace the O-Ring (P/N 46546) 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 f ive 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 from the back of the PCB and the PA flow

tube and remove the Valve/Sensor PCB.

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

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

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

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

16 Overhaul blender per instructions in Low Flow MicroBlender Service Manual P/N

L1130.

17 To replace the alarm reed components, locate the reed alarm cap.

This will be located either on the back of the unit to the right of t he inlet block or on the inlet gas block itself. Refer to directions in the blender service manual to replace the reed alarm.

Note:

If the alarm cap is not in either location, contact CareFusion technical support.

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66 Infant Flow

LP SiPAP Model M675

Figure 17: Blender and Components Removal/Fitting

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Fitting

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

frame panel.

2 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.

3 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.

4 Fit the front panel assembly (11) and install the eight screws (10). 5 Set the FiO

so that the pointer is in the 21 % position and install the control knob. For P/N 467472, install the cover (6).

6 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). 7 Install the input connection tube (4) on the elbow of the 8 Connect the connector at PL2 (3) on the Patient Trigger PCB. 9 Connect the connector PL5 (2) on the Main Processor PCB. 10 Connect the connector SK1 (1) on the LED PCB. 11 Install the battery.

collet on the blender to the 21 % position. Align the contr ol knob (7)

/8 “ silicone tube.

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68 Infant Flow

Removal and Fitting of Water Trap Filter

Refer to Figure 18.

Removal

1 Remove the filter bowl (1) using the water trap tool (P/N 673-051-A) included

with the IFSD.

2 Pull out and discard the filter (2) from the water trap.

Fitting

1 Install the new filter (P/N 467269) (2) in the water trap. 2 Screw on the water trap bowl (1) and tighten using the water trap tool.

Removal of the Pilot Drive Check Valves

LP SiPAP Model M675

Removal

1 Locate the pilot valve check valve behind the NCPAP flowmeter.

2. Cut the cable tie securing the valve to the flowmeter.

3. Remove the pilot drive check valve from tubing and discard.

4. Locate the pilot drive check valve behind the Pressure High Flowmeter. 5 Cut the cable tie securing the valve to the flowmeter.

6. Remove the pilot drive check valve from tubing and discard.

Fitting

1 Install the pilot drive check valve in tubing behind NCPAP Flowmeter .

2. Zip tie the check valve to the flowmeter.

3. Install the pilot drive check valve in tubing behind the Pressure Hig h Flowmeter. 4 Zip-tie the check valve to the flowmeter.

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Removal and Fitt ing of Case Bleed Filt ered Restrictor

Refer to Figure 18.

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 (P/N 467542) (3) to the tube in the

proper orientation. 2 Re-secure the restrictor to the sheet metal..

Figure 18: Water Trap Filter Removal/Fitting

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70 Infant Flow

LP SiPAP Model M675

Removal and Fitting of Val ve/Sensor PCB

See Figure 17.

Removal

1 Remove the case. 2 Disconnect the fuel cell connector SK1 (14) at PL1 on the Valve/sensor PCB. 3 Disconnect the dump/vent/valve connector SK3 (15) at PL3 on the Valve/Sensor

PCB.

4. Remove the five screws (16).

5. Pull the Valve/Sensor PCB (13) downwards and out forward to disconnect the PCB from the D Plug PL-2

6 Disconnect the exhaust tubes on the back of the PCB and the flow tube and

remove the Valve/Sensor PCB.

Fitting

1 Connect the exhaust tubes to back of PCB and PA Flow tube. 2 Fit the Valve/Sensor PCB (13) into the D plug PL2.

3. Fit the five screws (16).

4. Connect the fuel cell connector SK! (14) at PL1 on the Valve/Sensor PCB.

5 Connect the dump/vent valve connector to SK3 (15) at PL3 on the Valve/Sensor

PCB.

Removal and Fitting of the Muffler/Filter

Removal

1. Remove the screw that secures the Muffler/Filter to the rear panel.

2. Remove the Muffler/Filter from the tubing and discard.

Fitting

1 Insert the Muffler/Filter (P/N 11507) into the tubing. 2 Install screw that secures Muffler/Filter to the rear panel.

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Symbol

Source / Compliance

Meaning

DOCUMENTS

Symbol #01-14 IEC 30878

Symbol #5031 IEC 60417

This symbol indicates DIRECT CURRENT (DC)

Symbol #01-01 IEC 60878

Symbol #01-02 IEC 60878

Chapter 8 – Explanation of Symbols

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

2.5A/T 250 V 101010

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

Symbol #5032 IEC 60417

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

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

Symbol #5007 IEC 60417

Indicates ATTENTION, consult ACCOMPANYING

This symbol indicates an INTERNAL BATTERY FUSE

Fuse holder and fuse rating

Electrical AC in le t

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

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Symbol #5008 IEC 60417

Power ON (for part of the equipment)

MDD Directive 93/42/EEC CE Mark

Power OFF

Power OFF (for part of the equipment)

ETL Mark and Registration Number

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72 Infant Flow

Symbol

Source / Compliance

Meaning

connection.

LP SiPAP Model M675

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

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Service Manual 73

Symbol

Description

Symbols used on buttons: The following symbols are used to label user input areas within the g r aphical display.

As needed displays in this table are shown separately as Domestic US config urat ion 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

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74 Infant Flow

cycle is delivered regardless of button press duration

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

Toggle between Main Screen and Monitored Parameter Screen

Go to user calibration mode screen

LP SiPAP Model M675

%. One breath

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,

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Appendix A – Oxygen Leak Test

Oxygen Leak Test

This test should be performed after and Preventative Maintenance and/or repair has been done on the LP SiPAP. 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. Plug unit into Main AC.

2. Connect the oxygen analyzer sampling tube to the driver by replacing the M6 pan screw with an M6 fitting. Before operating the driver, take an initial O2 concentration reading. Plug the fitting.

3. Attach circuit and generator with prongs to unit. Switch the power on.

4. Press the Cal Icon on the touch screen and do a 2 point calibration of the O2 sensor (Figure A-1).

5. Set the NCPAP (Low Pressure) Flowmeter to about 8 LPM

SiPAP,

and then push the soft key button below the left Flowmeter icon (Figure A–

1).

, or 9 LPM on the LP

Figure A–1

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

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76 Infant Flow

7. Set the pre ssure Hi gh 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.

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

LP SiPAP Model M675

Figure A–2

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

Figure A–3

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Service Manual 77

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

(Figure A–4).

Figure A–4

11. Verify that the measured value on the external oxygen analyzer doesn’t exceed

23% FiO

. If so, then troubleshoot for an oxygen leak. Check all the fittings and

connections and repeat the Oxygen Leak Test (Figure A–5).

Figure A–5

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78 Infant Flow

Infant Flow

LP SiPAP an d SiPAP

Model M675

LP SiPAP Model M675

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Service Manual 79

Parameter

Min

Max

Accuracy

Units

Set Oxygen concentr ati on, %O2

100

15%

BiPhasic on time, T

(inspiration time)

0.1

3.0 *

± 0.005

seconds

BiPhasic rate, R (respiration rate)

120

0.5

respiration rate)

Parameter

Min

Max

Accuracy

Units

15%

Bi-level additional flow rate

15%

LPM

time)

0.5

Breath rate timeout

Seconds

DEFAULT SETTINGS

Inspiration Time

: 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

apnea

: 20 seconds (+/- 1%)

Appendix B – Product Configurations

Non-US Configuration Parameters

CPAP flow rate 0 15 Bi-level additional flow rate 0 5

-High

BiPhasic Tr backup rate, Rb (backup

1 120

± 0.5

LPM LPM

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.

US Configuration Parameters

Inspired oxygen fraction, FiO2 21 100 CPAP flow rate 0 15

BiPhasic on time, T-High (inspiration

BiPhasic rate, R (respiration rate) 1 54

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

0.1 3.0 *

-High

± 0.005

seconds

% LPM

seconds

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Infant Flow

LP SiPAP an d SiPAP

Model M675

LP SiPAP Model M675

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Service Manual 81

Part Number

Description

467472

BLENDER CONTROL KNOB (for blender part number 11329)

467468

CAP, BLENDER CONTROL KNOB

467471

POINTER, BLENDER CONTROL KNOB

467469

FLOWMETER KNOB

467470

CAP, FLOWMETER KNOB

675-308

CASE

467467

FOOT, POLYURETHANE .5OD

467466

WASHER M3 CRINKLE BECU (FOR CASE)

675-200

FLOWMETER MK3 HIGH

675-201

FLOWMETER MK 3 LOW

777244

PACKAGED BATTERY, MK3

47072

SPACER ROUND M4X155MM NYLON

467595

COMPRESSION PA D

673-051-A

WATERTRAP TOOL

465476

O-RING, PATIENT CONNECTOR

672-024-SA

ASSEMBLY, FILTER

465457

O-RING, O2 SCREW/FLOWMETER/GAS BLOCK

465474

O-RING, O2 FILTER

68289

FUEL CELL

675-230

PILOT DRIVE DUCKBILL ASSY

467542

CASE BLEED FILTER RESTRICTOR

52700A

VALVE/SENSO R PCB

467459

FUSE TIME LAG 2.5A 250V

467458

POWER INPUT TWIN FUSE

675-307

AUX FLOW MOUNTING BLOCK

11798

ASSY BLENDER (Manufactured in 2008 or later)

10003

MAINT KIT MCRBLNDR+LOFLO

675-300

EXHAUST TUBE 90 DEGREE

675-101-xxx

OPS MAN INF FLOW LP SiPAP SYSTEM

677-002

TRANSDUCER INTERFACE

467349

ABDOMINAL RESP SENSOR 25PK

03895

VALVE CHECK DCKBL BLACK

06804

FILTER NYLON CONE INL

467269

FILTER ELEMENT (WATERTRAP)

Appendix C – Spare Parts

09220 FLOWMETER, AUXILIARY

465464 FILTER, WATERTRAP

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82 Infant Flow

Part Number

Description

467455

SWITCH COVER

22562

BLENDER KNOB (for blender part number 11798)

675-256

SWITCH CABLE ASSY

675-310-EN

FRONT PANEL (English)

675-310-FR

FRONT PANEL (French)

675-310-RO

FRONT PANEL (Icon)

675-316

MK3 TRIGGER LEUR

675-209

O2 SENSOR CABLE

777242-101

SERVICE KIT, Mk3 DRIVER ANNUAL

777242-103

SERVICE KIT, Mk3 DRIVER 5 YEAR

777072-101

ASSY O2 /AIR FITTINGS MARK III DISS

777072-102

ASSY O2 AIR FITTINGS MARK III NIST

777072-103

ASSY O2 /AIR FIT MARKIII FEMALE DISS

777072-103

ASSY O2 AIR FIT MARKIII AIR LIQUIDE

461964

CABLE TIE, BATTERY

52000-00239

CABLE TIE, CHECK VALVE ASSEMBLY

11329

ASSEMBLY BLENDER (MANUFACTURED BEFORE 2008)

93244

BLENDER KNOB REMOVAL TOOL FOR KNOB P/N 22562

L1130

LOW FLOW MICROBLENDER SERVIC E MANUAL

675-312 CONNECTOR PATIENT INLET

LP SiPAP Model M675

11431 ASSEMBLY, AUXILLIARY FLOWMETER

675-316 PROXIMAL PRESSURE LINE PORT

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Service Manual 83

Appendix D – Pneumatics Assembly

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84 Infant Flow

LP SiPAP Model M675

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Service Manual 85

Glossary

Term Meaning

Apnea

Bpm

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

Generator I/E Inspiration/Expiration ratio

IFSD Infant Flow® LP SiPAP Driver LBR Low Breath Rate monitoring (US labeling) LPM Liters per minute MAP Mean Airway Pressure

BiPhasic BiPhasic+Apnea BiPhasic Ventilation with Apnea monitoring (non-US labe ling)

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 Pressur e PIP Peak Inspired Pressure BiPhasic Flow Inspiratory Pressure

Rate Mandatory BiPhasic rate ( per minute) RB 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

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

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86 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 

LP SiPAP Model M675

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. G

CareFusion Infant Flow LP SiPAP M675 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Service manual

Revision History

Warranty

Limitation of Liabilities

Contents

Notices

EMC Notice

MRI Notice

Intended Use Not ice

Regulatory No t ice

Classification

Declaration of Conformity Notice

Chapter 1 – Product Description

Chapter 2 – Product Specifications

Modes

Controls

Monitors

Alarms

Pneumatic Supply

Electrical Supply

Atmospheric & Environmental

Physical

Chapter 3 – Warnings and Cautions

Terms

Warnings

Cautions

Chapter 4 – System Construction

Gas Module

Electronics Module

Front Panel Module

Patient Trigger Module (P lus and Comprehensive Models)

Firmware Module

Touch Screen

Battery Status and Chargi ng Indicator

Alarm Button

Caution/Information

Mode Indicator

Patient Trigger Indicator (Plus and Comprehensive Models)

Alarm Conditions

Diagnostic Screen

Chapter 5 – Theory of Operation

Gas Flow

Auxiliary Output (Opti ona l)

Inspiratory Pressure

Triggered BiPhasic

Operation without E lectrical Power

Electronic Functions

Electrical Layo ut

Fault Management

Chapter 6 – Operational Setup

Preparing and Connecting the Equipment

Switching On the IFSD

User Verification Test

Power-on Check

Two Point O2 Sensor Calibratio n

Leak Test

Alarms Test

Infant Flow® LP SiPAP/SiPAP User Verification Test Checklist

Setting up the Equipment

Setting the NCPAP Parameters

Setting the BiPh asic Parameters

Setting the Trigg er ed BiPhasic Parameters

Calibration

Giving a Manual Timed Sigh

Operation Without Electrical Power

Fault Indications

Discharged Battery

Fault Lockout

Over Pressure Indications

Diagnostics

PM Procedure

Tools Required

Cleaning

General

Removal and Fitting of Parts – General

Removal and Fitting of Case