Care Fusion M675 User manual

675-120 Revision C November 2004
Service Manual
Infant Flow® SiPAP
Model M675
© Copyright 2004, VIASYS Healthcare Critical Care

2Infant Flow®SiPAP
675-120 Revision C November 2004

Service Manual 3
675-120 Revision C November 2004
Revision History
Date Revision Pages Changes
September 2003 675-120(1) All Release
November 2004 B All Release manual in VIASYS Healthcare
template using VIASYS Healthcare Critical
Care nomenclature.
December 2004 C Title page, 19,
30, 39, 45, 50,
56, 57, 61, 62,
64, 65, 68, 69,
73, 75, 81–83,
86, 87, 88
Revised per EO 27980.
Removed the picture from the title page.
Deleted the ESD warning from page 19.
Removed “O2 Sensor” and added the word
“measured” on page 30.
Changed “O2 sensor” to “fuel cell” on
pages 39, 45, 62, 68, 69, 73, 86, and 87.
Replaced the O2 senor row on page 50.
Updated the error codes on pages 56 and
57.
Replaced the warning on page 61.
Changed the Fitting procedure on pages
64, 68, and 75.
Changed step 6 on page 65.
Added Addendum A – Oxygen Leak Test
Changed Transducer Assy. to Transducer
Interface on page 88.

4Infant Flow®SiPAP
675-120 Revision C November 2004
Contact and Ordering Information
United States, Latin America, Asia Pacific:
Sales, Service and Clinical Support:
VIASYS Healthcare
Critical Care Division
22705 Savi Ranch Parkway
Yorba Linda, CA 92887
Phone: [phone]
[phone]
Fax: [phone]
www.VIASYShc.com
United Kingdom:
Sales, Service and Clinical Support:
VIASYS Healthcare
3 Welton Rd.
Warwick,
CV34 5PZ
Phone: [phone]
Fax: [phone]
Europe
Sales and Customer Service Technical Service
VIASYS Healthcare VIASYS Healthcare
Critical Care Division Leibnizstrasse 7
22705 Savi Ranch Parkway D-97204 Hoechburg
Yorba Linda, CA 92887 Germany
Phone: [phone] Phone [phone] – 0
[phone] Fax:[phone]
e-mail: [email protected]
website: www.VIASYShc.com

Service Manual 5
675-120 Revision C November 2004
Warranty
The Infant Flow® SiPAP is warranted to be free from defects in material and
workmanship and to meet the published specifications for One (1) year from date of
shipment.
The liability of VIASYS Healthcare, Critical Care Division, (referred to as the
Company) under this warranty is limited to replacing, repairing or issuing credit, at
the discretion of the Company, for parts that become defective or fail to meet
published specifications during the warranty period; the Company will not be liable
under this warranty unless (A) the Company is promptly notified in writing by Buyer
upon discovery of defects or failure to meet published specifications; (B) the
defective unit or part is returned to the Company, transportation charges prepaid by
Buyer; (C) the defective unit or part is received by the Company for adjustment no
later than four weeks following the last day of the warranty period; and (D) the
Company’s examination of such unit or part shall disclose, to its satisfaction, that
such defects or failures have not been caused by misuse, neglect, improper
installation, unauthorized repair, alteration or accident.
Any authorization of the Company for repair or alteration by the Buyer must be in
writing to prevent voiding the warranty. In no event shall the Company be liable to
the Buyer for loss of profits, loss of use, consequential damage or damages of any
kind based upon a claim for breach of warranty, other than the purchase price of any
defective product covered hereunder.
The Company warranties as herein and above set forth shall not be enlarged,
diminished or affected by, and no obligation or liability shall arise or grow out of the
rendering of technical advice or service by the Company or its agents in connection
with the Buyer's order of the products furnished hereunder.
Limitation of Liabilities
This warranty does not cover normal maintenance such as cleaning, adjustment or
lubrication and updating of equipment parts. This warranty shall be void and shall not
apply if the equipment is used with accessories or parts not manufactured by the
Company or authorized for use in writing by the Company or if the equipment is not
maintained in accordance with the prescribed schedule of maintenance.
The warranty stated above shall extend for a period of One (1) year from date of
shipment, with the following exceptions:
1. Components for monitoring of physical variables such as temperature,
pressure, or flow are warranted for ninety (90) days from date of receipt.
2. Elastomeric components and other parts or components subject to
deterioration, over which the Company has no control, are warranted for sixty
(60) days from date of receipt.
3. Internal batteries are warranted for ninety (90) days from the date of receipt.
The foregoing is in lieu of any warranty, expressed or implied, including, without
limitation, any warranty of merchantability, except as to title, and can be amended
only in writing by a duly authorized representative of the Company.

6Infant Flow®SiPAP
675-120 Revision C November 2004
Contents
Revision History.................................................................................... 3
Contact and Ordering Information ...................................................... 4
Warranty ................................................................................................ 5
Limitation of Liabilities ...................................................................................................5
Contents ................................................................................................ 6
Notices................................................................................................... 8
Copyright Notice............................................................................................................8
Trademark Notices........................................................................................................8
EMC Notice ...................................................................................................................8
MRI Notice.....................................................................................................................9
Intended Use Notice......................................................................................................9
Regulatory Notice..........................................................................................................9
Classification .................................................................................................................9
Declaration of Conformity Notice.................................................................................10
Chapter 1 - Product Description........................................................ 12
Infant Flow® SiPAP Features.............................................................. 12
Chapter 2 - Product Specifications ................................................... 14
Modes..........................................................................................................................14
Controls.......................................................................................................................14
Monitors.......................................................................................................................14
Alarms .........................................................................................................................15
Pneumatic Supply........................................................................................................15
Electrical Supply..........................................................................................................15
Atmospheric & Environmental.....................................................................................16
Physical.......................................................................................................................16
Chapter 3: Summary of Warnings and Cautions ............................. 18
Terms ................................................................................................... 18
Warnings .....................................................................................................................18
Cautions ......................................................................................................................20
Chapter 4: System Construction....................................................... 22
Touch Screen..............................................................................................................26
Alarm Conditions.........................................................................................................27
Diagnostic Screen .......................................................................................................28
Chapter 5 - Operation ......................................................................... 30
Gas Flow .....................................................................................................................30
Electronic Functions....................................................................................................32
Electrical Layout..........................................................................................................33
Fault Management.......................................................................................................34
Chapter 6 - Operation ......................................................................... 36

Service Manual 7
675-120 Revision C November 2004
Preparing and Connecting the Equipment...................................................................36
Setting Up the Equipment............................................................................................40
Setting the NCPAP Parameters...................................................................................41
Setting the BiPhasic Parameters.................................................................................42
Setting the Triggered BiPhasic Parameters.................................................................43
Calibration....................................................................................................................44
Giving a Manual Timed Sigh........................................................................................45
Operation Without Electrical Power.............................................................................45
Fault Indications...........................................................................................................45
Diagnostics..................................................................................................................52
Chapter 7- Maintenance......................................................................60
Cleaning ...............................................................................................60
Maintenance.........................................................................................60
General........................................................................................................................60
Maintenance Frequencies ...........................................................................................61
Removal and Fitting of Case .......................................................................................62
Removal and Fitting of Battery ....................................................................................62
Removal and Fitting of Oxygen Filter ..........................................................................65
Removal and Fitting of Fuel Cell Filter/Restrictor........................................................66
Removal and Fitting of the Fuel Cell............................................................................67
Removal and Fitting of Blender and Components.......................................................68
Removal and Fitting of Water Trap Filter.....................................................................71
Removal and Fitting of Case Bleed Filtered Restrictor................................................72
Removal and Fitting of PA Solenoid Valve..................................................................73
Firmware Reload/Upgrade...........................................................................................73
Testing.........................................................................................................................74
Chapter 8 – Explanation of Symbols.................................................75
Symbols used on buttons...................................................................77
Appendix A- Oxygen Leak Test..........................................................79
Appendix B- Product Configurations................................................82
Non-US Configuration Parameters.....................................................82
US Configuration Parameters................................................................82
Appendix C - Spare Parts.................................................................83
Additional Service Parts.....................................................................84
Glossary...............................................................................................87

8Infant Flow®SiPAP
675-120 Revision C November 2004
Notices
Copyright Notice
Copyright © 2004 VIASYS Healthcare, Critical Care Division, California.
This work is protected under Title 17 of the U.S. Code and is the sole property of the
Company. No part of this document may be copied or otherwise reproduced, or
stored in any electronic information retrieval system, except as specifically permitted
under U.S. Copyright law, without the prior written consent of the Company. For
more information, contact:
World Headquarters European Office
1100 Bird Center Drive Rembrandtlaan 1b
Palm Springs, CA 92262-8099 3723 BG Bilthoven
U.S.A. P.O. Box 299, 3720 AG Bilthoven
Phone: [phone] The Netherlands
[phone] Phone:[phone]
Fax: [phone] Fax: [phone]
www.VIASYSCriticalCare.com
Trademark Notices
Infant Flow® and SiPAP are trademarks of VIASYS Healthcare, Critical Care Division
in the U.S. and some other countries. All other brand names and product names
mentioned in this manual are trademarks, registered trademarks, or trade names of
their respective holders.
EMC Notice
This equipment radiates and is susceptible to radio frequency energy. If not installed
and used in accordance with the instructions in this manual, electromagnetic
interference may result. The equipment has been tested and found to comply with
the limits set forth in BS EN60601-1-2 for Medical Electrical Equipment Part 1-2:
General requirements for safety-collateral standard. Electromagnetic compatibility –
requirements and tests. These limits provide reasonable protection against
electromagnetic interference when operated in the intended use environments (e.g.
hospitals) described in this manual.
This device is also designed and manufactured to comply with the following
standards;
Safety: UL 60601-1: 2003 Medical Electrical Equipment, Part 1: General
Requirements for Safety.
CAN/CSA C22.2 No 601.1-M90, Medical Electrical Equipment - Part
1: General Requirements for Safety including C22.2 No. 601.1S1-94
(IEC601-1, Amendment 1:1991) Supplement No. 1-94 to CAN/CSA
22.2 No. 601.1-M90

Service Manual 9
675-120 Revision C November 2004
With regards to Electrical Safety:
Class 1 equipment
Contains type BF patient applied parts
Continuous Operation
MRI Notice
This equipment contains electromagnetic components whose operation can be
affected by intense electromagnetic fields.
Do not operate this device in a MRI environment or in the vicinity of high-frequency
surgical diathermy equipment, defibrillators, or short-wave therapy equipment.
Electromagnetic interference could disrupt the operation of the device.
Intended Use Notice
The Infant Flow® SiPAP, consisting of a Driver and Generator plus NCPAP Prongs
and Masks, is a medical device intended for the provision of Bi-Level CPAP to
produce a sigh. This system is for use in Hospital, Hospital Type facilities and intra-
Hospital transport environments and is indicated for the treatment of Newborn and
Infant patients.
Operators of this equipment and Service Engineers are required to read and thoroughly
understand the contents of this manual before using or maintaining the equipment.
This manual is intended for use by a competent, fully qualified Service
Engineer. It includes a description of the unit and how it works. It also contains
operating and diagnostic procedures and maintenance instructions. For usage
of associated equipment, refer to the Manufacturer’s literature.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
Classification
Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1
Protected, and uses type BF applied parts. Equipment is not suitable for use in
presence of flammable anesthetics.

10 Infant Flow®SiPAP
675-120 Revision C November 2004
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and
the following Technical Standards, to which Conformity is declared:
Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4)
Safety:EN 60601-1, EN 794-1
EMC: EN 60601-1-2:2001
Conformity Assessment: MDD Annex II
Quality System: ISO 13485
EU Notified Body: BSI (Reg. No. 0086)
Device Classification: IIb
EU Notified Body:
BSI (Reg. No. 0086)
Trade names:
Infant Flow SiPAP
Manufactured by:
SensorMedics Corporation
22705 Savi Ranch Parkway
Yorba Linda, CA 92887, USA
If you have a question regarding the Declaration of Conformity for this product,
please contact VIASYS Healthcare, Critical Care Division.

Service Manual 11
675-120 Revision C November 2004

12 Infant Flow®SiPAP
675-120 Revision C November 2004
Chapter 1 - Product Description
The Infant Flow® SiPAP is a non-invasive form of respiratory support designed for
use in hospital environments such as Neonatal and Pediatric Intensive Care Units. It
can also be used when transporting patients within the hospital environment.
The Infant Flow® SiPAP is currently available in a Plus or 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® SiPAP comes standard in all configurations with an LCD touch screen
display, pressure time waveform graphics, integrated patient monitoring, alarms for
high and low pressure and FiO2and up to 2 hours of backup battery power.
As a result of the unique patented design, the Infant Flow® SiPAP has been proven
to provide the most stable CPAP at the lowest work of breathing for patients
compared to other devices. The outstanding performance of the Infant Flow® SiPAP
is irrespective of patient demand or expiratory flows. This system has been designed
and tested to perform optimally when used only with accessories available from
VIASYS Healthcare, Inc. These accessories include circuits and generators, prong
and mask patient interfaces and bonnets.
Infant Flow® SiPAP Features
The expanded capabilities of the Infant Flow® SiPAP Plus and Comprehensive
configurations allow for applications to broader range of patients who may otherwise
not be candidates for non-invasive respiratory support.
NCPAP – allows for continuous positive airway pressure based on clinician set
pressure. Breath rate monitoring/alarm can be activated in this mode.
BiPhasic - allows for time triggered pressure assists to be delivered based on
clinician set inspiratory time, rate, and pressure criteria. Breath rate monitoring/alarm
can be activated in this mode.
BiPhasic tr* - allows for patient triggered pressure assists to be delivered based on
clinician set inspiratory time and pressure criteria. Breath rate monitoring/alarm, and
Apnea backup breaths are automatically active in the mode.
Patented Infant Flow® Generator - The Infant Flow® Generator is a fluidic device for
the generation of consistent infant nasal CPAP with a low work of breathing
compared to other devices.
Fully integrated alarms packages – . Supply gases failure, High Patient Pressure,
Low patient pressure, high and low delivered Oxygen concentration, change from AC
to DC power source, low and flat battery charge status and Low breath rate/apnea
alarm.
Battery Backup – Up to 2 hours of battery backup allows for intra-hospital transport.
Clear indicators are provided for power supply in use (AC or DC), and battery charge
level.

Service Manual 13
675-120 Revision C November 2004
Screen Lock - After 120 seconds of no screen inputs, the screen changes to the
Locked Screen to prevent inadvertent changes. Upon activation of a high priority
alarm the screen changes to an unlocked state to allow for immediate interventions
as required.
Table 1 – Functions and Accessories
Functions & Accessories Plus Comprehensive*
NCPAP ••
NCPAP with breath rate monitoring
and alarm ••
BiPhasic ••
BiPhasic with breath rate monitoring
and alarm ••
BiPhasic tr* •
Internal Battery ••
Manual Breath ••
Apnea Back up rate •
Screen lock ••
Prioritization of alarms ••
*Comprehensive configuration not available for sale in the United States
CAUTION
The Infant Flow SiPAP™ has been designed and tested as a complete system using
Infant Flow™ accessories. Only accessories approved for use should be used. If in
doubt, please contact your local VIASYS representative.

14 Infant Flow®SiPAP
675-120 Revision C November 2004
Chapter 2 - Product Specifications
Modes
•NCPAP
•NCPAP with breath rate monitoring and low rate alarm
•BiPhasic (time triggered)
•BiPhasic (time triggered) with breath rate monitoring and low rate alarm
•BiPhasic tr (patient triggered ) with breath rate monitoring, low breath rate
alarm, and apnea back up
Controls
•Inspiratory Time (Ti) – 0.1-3.0 seconds
•Rate (R) – 1-120 (Comprehensive* only)
•Rate (R) – 1-54 (Plus only)
•Apnea Interval (Tapnea) – 10-30 seconds, 5 second intervals (Comp* only)
•Apnea Interval (TLBR) – 10-30 seconds, 5 second intervals (Plus only)
•NCPAP/Pres Low flow meter – 0-15L/min, accuracy +/- 15% of selected
output
•NCPAP/Pres High flow meter – 0-5L/min, accuracy +/- 15% of selected
output
•Manual Breath – X 1
•Rate monitoring on/off – NCPAP
•%O2– 21 - 100% - accuracy +/-3%
Monitors
•CPAP
•PEEP
•MAP
•PIP
•%O2
•I:E ratio
•Spontaneous rate (Rs)
•Battery charge level

Service Manual 15
675-120 Revision C November 2004
Alarms
•High airway pressure – 3 cmH20 above measured airway pressure
•High circuit pressure – maximum 11 cmH20 in time triggered Biphasic mode
•High circuit pressure – maximum 15 cmH20 in patient triggered Biphasic tr*
mode
•Low airway pressure – 2 cmH20 below measured airway pressure or 1
cmH20 if otherwise would be zero
•High and Low delivered Oxygen concentration +5% of setting
•Low breath rate alarm
•Low or Flat battery charge level
•Input gases failure
•Alarm volume (electronic alarms) 70 dBa at 1 meter
Pneumatic Supply
•Patient Gas Outlet - 15 mm standard taper fitting
•Patient Pressure Input - 4.5 mm Luer taper fitting
•Gas Supply - Nominal 4 bar, clean, dry medical air and oxygen
•Range - 2.8 - 6 bar; Maximum differential pressure 2 bar
•Manometer - Range 0 to + 20 cmH2O, accuracy, ±2% of span
•Gas Connections - Standard DISS or NIST connectors
Electrical Supply
•Input Voltage -100-230 VAC
•Input Frequency -50/60 Hz
•Power Consumption -50 VA maximum
•Fuse Rating For 220 V nominal operation-“T” Type 2.5 A at 250 V
•Device Housing Protection rating level -IPX1
•Battery Working Time -2 hours (from fully charged state)
•Battery Charging Time –max. 16 hours

16 Infant Flow®SiPAP
675-120 Revision C November 2004
Atmospheric & Environmental
•Temperature Range-Operating: 5 – 40° C
•Storage: 0 - 50° C
•Relative Humidity -Operating: 0 – 90% non-condensing
•Storage: 0 – 90% non-condensing
Physical
•Dimensions (driver only)-(W x H x D) 26 x38 x 23.5 cm /
10.25 x15 x 9.25 in
•Weight (driver only)-8.8 kg / 19.5 lb

Service Manual 17
675-120 Revision C November 2004

18 Infant Flow®SiPAP
675-120 Revision C November 2004
Chapter 3: Summary of Warnings and
Cautions
Please review the following safety information prior to operating the Infant Flow®
SiPAP. Attempting to operate this equipment without fully understanding its features
and functions may result in unsafe operating conditions.
Warnings and Cautions, which are general to the use of the device under all
circumstances, are included in this section. Some Warnings and Cautions are also
inserted within the manual where they are most meaningful.
Notes are also located throughout the manual to provide additional information
related to specific features.
If you have a question regarding the installation, set up, operation, or maintenance of
the device, contact VIASYS Healthcare Customer Care.
Terms
WARNINGS identify conditions or practices that could result in serious adverse
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
the ventilator works.
Warnings
•Whenever a patient is attached to respiratory care equipment, constant
attendance is required by qualified personnel. The use of an alarm or
monitoring system does not give absolute assurance of warning for every
malfunction that may occur in the system. In addition, some problems may
require immediate attention.
•The gas blender incorporated in this product is designed to mix medical
grade air and oxygen only. Do not modify the inlets to accommodate other
source gases such as anesthetic gases.
•Check that the water trap is empty before use and empty it frequently during
use.
•Liquid water or other contaminants in either gas supply, particularly the air
supply, may cause malfunction of this equipment and equipment connected
to it.

Service Manual 19
675-120 Revision C November 2004
•When filling a humidifier, do not move the stand. Moving or transporting the
stand while refilling may cause the stand and equipment to over balance.
•Do not use conductive patient circuits with the Infant Flow SiPAP Driver.
•Nasal CPAP can cause nasal irritation, septal distortion, skin irritation and
pressure necrosis. Observe the usage guidelines to minimize these
complications.
•This device exhausts O2during normal operation. Oxygen vigorously
accelerates combustion. To avoid fire hazard, do not place flammable
materials or sources of heat close to the exhaust.
•Do not use the equipment without the exhaust tube fitted (refer to Figure 2).
•To reduce trip hazard, always ensure cable and tubes are restrained away
from walking areas.
•The Abdominal Respiratory Sensor will not detect all forms of apnea.
Independent monitoring should always be used with this device.
•If the unit is shelf mounted, ensure that the unit is stable and that hoses and
cables are restrained to avoid hazard of toppling.
•This equipment is not suitable for use in the presence of a flammable
anesthetic mixture.
•The NCPAP Pres High flowmeter must be adjusted to zero when not required
for the patient.
•Under extreme conditions (minimum supply pressure and maximum gas
demand, including auxiliary output) output flow rates and delivered pressure
may be reduced.
•Only use the supplied AC cable to connect to the power supply.
•Do not attach the Generator to the patient until the initial set up is complete.
•The indicates a connection between the transducer interface and the
unit. It does not indicate correct positioning of the Abdominal Respiratory
Sensor.
•Calibration must only be done when the unit is not connected to the patient.
•Ensure the whistle sounds during gas connection. If not, the device may be
faulty and should not be used. Refer to your Service Engineer.
•Verify that the displayed value for delivered FiO2corresponds to the value set
on the blender. Refer to Faults and Indications.
•Oxygen vigorously accelerates combustion. To avoid explosion hazard, do
not use any instrument or other equipment that may have been exposed to oil
or grease contamination.

20 Infant Flow®SiPAP
675-120 Revision C November 2004
Cautions
•Federal Law (USA) restricts this device to sale by or on the order of a
physician.
•The precision gas blender in this product may become non-functional or
damaged if used without the protective water trap and filters provided.
•The power switch on this unit does not isolate the external power supply.
Disconnect the power supply cable to ensure complete isolation.
•Before use, verify that this equipment has been authorized for use by a
qualified person.
•The Infant Flow SiPAP™ has been designed and tested as a complete
system using Infant Flow™ accessories. Only accessories approved for use
should be used. If in doubt, please contact your local VIASYS representative.
•Where the integrity of the external protective earth conductor is in doubt, the
equipment shall be powered by its internal power source (battery).
•Do not immerse any part of the IFSD in water or sterilize it with gas or steam.
•Ensure patient breathing circuit is replaced at regular intervals.