Revised per EO 27980.
Removed the picture from the title page.
Deleted the ESD warning from page 19.
Removed “O2 Sensor” and added the word
“measured” on page 30.
Changed “O2 sensor” to “fuel cell” on
pages 39, 45, 62, 68, 69, 73, 86, and 87.
Replaced the O2 senor row on page 50.
Updated the error codes on pages 56 and
57.
Replaced the warning on page 61.
Changed the Fitting procedure on pages
64, 68, and 75.
Changed step 6 on page 65.
Added Addendum A – Oxygen Leak Test
Changed Transducer Assy. to Transducer
Interface on page 88.
Revised per ECO 60329
Update address/contact info
Update battery remove/install procedure
Added note for fuel cell disposal
Update check valve assy remove/install
procedure
Update water trap & restrictor
remove/install procedure
Delete redundant leak test
Update list of service parts
675-120 Revision D May 2005
4 Infant Flow
Contact and Ordering Information
United States, Latin America, Asia Pacific:
Sales, Service and Clinical Support:
VIASYS Healthcare
Respiratory Care
22745 Savi Ranch Parkway
Yorba Linda, CA 92887
Phone: (714) 283-8444
(800) 381-3552
Fax: (714) 283-8493
www.VIASYShc.com
United Kingdom:
Sales, Service and Clinical Support:
VIASYS Healthcare
3 Welton Rd.
Warwick,
CV34 5PZ
Phone: 01926 490888
Fax: 01926 402262
®
SiPAP
Europe
Sales and Customer Service Technical Service
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, Respiratory Care, (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.
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:
Infant Flow® and SiPAP are trademarks of VIASYS Healthcare, Respiratory Care in
the U.S. and some other countries. All other brand names and product names
mentioned in this manual are trademarks, registered trademarks, or trade names of
their respective holders.
EMC Notice
This equipment radiates and is susceptible to radio frequency energy. If not installed
and used in accordance with the instructions in this manual, electromagnetic
interference may result. The equipment has been tested and found to comply with
the limits set forth in BS EN60601-1-2 for Medical Electrical Equipment Part 1-2:
General requirements for safety-collateral standard. Electromagnetic compatibility –
requirements and tests. These limits provide reasonable protection against
electromagnetic interference when operated in the intended use environments (e.g.
hospitals) described in this manual.
This device is also designed and manufactured to comply with the following
standards;
Safety:UL 60601-1: 2003 Medical Electrical Equipment, Part 1: General
Requirements for Safety.
CAN/CSA C22.2 No 601.1-M90, Medical Electrical Equipment - Part
1: General Requirements for Safety including C22.2 No. 601.1S1-94
(IEC601-1, Amendment 1:1991) Supplement No. 1-94 to CAN/CSA
22.2 No. 601.1-M90
675-120 Revision D May 2005
Service Manual 9
With regards to Electrical Safety:
Class 1 equipment
Contains type BF patient applied parts
Continuous Operation
MRI Notice
This equipment contains electromagnetic components whose operation can be
affected by intense electromagnetic fields.
Do not operate this device in a MRI environment or in the vicinity of high-frequency
surgical diathermy equipment, defibrillators, or short-wave therapy equipment.
Electromagnetic interference could disrupt the operation of the device.
Intended Use Notice
The Infant Flow® SiPAP, consisting of a Driver and Generator plus NCPAP Prongs
and Masks, is a medical device intended for the provision of Bi-Level CPAP to
produce a sigh. This system is for use in Hospital, Hospital Type facilities and intraHospital transport environments and is indicated for the treatment of Newborn and
Infant patients.
Ope r a t o r s o f t h i s e q u i p m ent a n d S e r v i c e Engi neers are required to read and thoroughly
understand the contents of this manual before using or maintaining the equipment.
This manual is intended for use by a competent, fully qualified Service
Engineer. It includes a description of the unit and how it works. It also contains
operating and diagnostic procedures and maintenance instructions. For usage
of associated equipment, refer to the Manufacturer’s literature.
Regulatory Notice
Federal law restricts the sale of this device except by or on order of a physician.
Classification
Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1
Protected, and uses type BF applied parts. Equipment is not suitable for use in
presence of flammable anesthetics.
675-120 Revision D May 2005
10 Infant Flow
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and
the following Technical Standards, to which Conformity is declared:
Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4)
Safety: EN 60601-1, EN 794-1
EMC: EN 60601-1-2:2001
Conformity Assessment: MDD Annex II
Quality System: ISO 13485
EU Notified Body: BSI (Reg. No. 0086)
Device Classification: IIb
SensorMedics Corporation
22745 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, Respiratory Care.
675-120 Revision D May 2005
Service Manual 11
675-120 Revision D May 2005
12 Infant Flow
Chapter 1 - Product Description
The Infant Flow® SiPAP is a non-invasive form of respiratory support designed for
use in hospital environments such as Neonatal and Pediatric Intensive Care Units. It
can also be used when transporting patients within the hospital environment.
The Infant Flow
configuration. The Plus configuration provides NCPAP and time triggered, BiPhasic
modes with and without breath rate monitoring. The Comprehensive configuration
offers these features plus patient BiPhasic mode with apnea backup breaths. The
Infant Flow
display, pressure time waveform graphics, integrated patient monitoring, alarms for
high and low pressure and FiO
As a result of the unique patented design, the Infant Flow
to provide the most stable CPAP at the lowest work of breathing for patients
compared to other devices. The outstanding performance of the Infant Flow
is irrespective of patient demand or expiratory flows. This system has been designed
and tested to perform optimally when used only with accessories available from
VIASYS Healthcare, Inc. These accessories include circuits and generators, prong
and mask patient interfaces and bonnets.
®
SiPAP is currently available in a Plus or Comprehensive
®
SiPAP comes standard in all configurations with an LCD touch screen
and up to 2 hours of backup battery power.
2
®
SiPAP has been proven
®
®
SiPAP
SiPAP
Infant Flow® SiPAP Features
The expanded capabilities of the Infant Flow® SiPAP Plus and Comprehensive
configurations allow for applications to broader range of patients who may otherwise
not be candidates for non-invasive respiratory support.
NCPAP – allows for continuous positive airway pressure based on clinician set
pressure. Breath rate monitoring/alarm can be activated in this mode.
BiPhasic - allows for time triggered pressure assists to be delivered based on
clinician set inspiratory time, rate, and pressure criteria. Breath rate monitoring/alarm
can be activated in this mode.
BiPhasic tr* - allows for patient triggered pressure assists to be delivered based on
clinician set inspiratory time and pressure criteria. Breath rate monitoring/alarm, and
Apnea backup breaths are automatically active in the mode.
®
Patented Infant Flow
the generation of consistent infant nasal CPAP with a low work of breathing
compared to other devices.
Fully integrated alarms packages – . Supply gases failure, High Patient Pressure,
Low patient pressure, high and low delivered Oxygen concentration, change from AC
to DC power source, low and flat battery charge status and Low breath rate/apnea
alarm.
Generator - The Infant Flow® Generator is a fluidic device for
Battery Backup – Up to 2 hours of battery backup allows for intra-hospital transport.
Clear indicators are provided for power supply in use (AC or DC), and battery charge
level.
675-120 Revision D May 2005
Service Manual 13
Screen Lock - After 120 seconds of no screen inputs, the screen changes to the
Locked Screen to prevent inadvertent changes. Upon activation of a high priority
alarm the screen changes to an unlocked state to allow for immediate interventions
as required.
Table 1 - Functions and Accessories
Functions & Accessories Plus Comprehensive*
NCPAP
NCPAP with breath rate monitoring
and alarm
BiPhasic
BiPhasic with breath rate monitoring
and alarm
BiPhasic tr*
Internal Battery
Manual Breath
Apnea Back up rate
Screen lock
Prioritization of alarms
*Comprehensive configuration not available for sale in the United States
CAUTION
The Infant Flow SiPAP™ has been designed and tested as a complete system using
Infant Flow™ accessories. Only accessories approved for use should be used. If in
doubt, please contact your local VIASYS representative.
• •
• •
• •
• •
• •
• •
• •
• •
•
•
675-120 Revision D May 2005
14 Infant Flow
Chapter 2 - Product Specifications
Modes
• NCPAP
• NCPAP with breath rate monitoring and low rate alarm
• BiPhasic (time triggered)
• BiPhasic (time triggered) with breath rate monitoring and low rate alarm
•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
®
SiPAP
675-120 Revision D May 2005
Service Manual 17
675-120 Revision D May 2005
18 Infant Flow
®
SiPAP
Chapter 3: Summary of Warnings and
Cautions
Please review the following safety information prior to operating the Infant Flow
SiPAP. Attempting to operate this equipment without fully understanding its features
and functions may result in unsafe operating conditions.
Warnings and Cautions, which are general to the use of the device under all
circumstances, are included in this section. Some Warnings and Cautions are also
inserted within the manual where they are most meaningful.
Notes are also located throughout the manual to provide additional information
related to specific features.
If you have a question regarding the installation, set up, operation, or maintenance of
the device, contact VIASYS Healthcare Customer Care.
Terms
WARNINGS identify conditions or practices that could result in serious adverse
CAUTIONS identify conditions or practices that could result in damage to the
NOTES identify supplemental information to help you better understand how
®
reactions or potential safety hazards.
ventilator or other equipment.
the ventilator works.
Warnings
• Whenever a patient is attached to respiratory care equipment, constant
attendance is required by qualified personnel. The use of an alarm or
monitoring system does not give absolute assurance of warning for every
malfunction that may occur in the system. In addition, some problems may
require immediate attention.
• The gas blender incorporated in this product is designed to mix medical
grade air and oxygen only. Do not modify the inlets to accommodate other
source gases such as anesthetic gases.
• Check that the water trap is empty before use and empty it frequently during
use.
• Liquid water or other contaminants in either gas supply, particularly the air
supply, may cause malfunction of this equipment and equipment connected
to it.
675-120 Revision D May 2005
Service Manual 19
• When filling a humidifier, do not move the stand. Moving or transporting the
stand while refilling may cause the stand and equipment to over balance.
• Do not use conductive patient circuits with the Infant Flow SiPAP Driver.
• Nasal CPAP can cause nasal irritation, septal distortion, skin irritation and
pressure necrosis. Observe the usage guidelines to minimize these
complications.
• This device exhausts O
during normal operation. Oxygen vigorously
2
accelerates combustion. To avoid fire hazard, do not place flammable
materials or sources of heat close to the exhaust.
• Do not use the equipment without the exhaust tube fitted (refer to Figure 2).
• To reduce trip hazard, always ensure cable and tubes are restrained away
from walking areas.
• The Abdominal Respiratory Sensor will not detect all forms of apnea.
Independent monitoring should always be used with this device.
• If the unit is shelf mounted, ensure that the unit is stable and that hoses and
cables are restrained to avoid hazard of toppling.
• This equipment is not suitable for use in the presence of a flammable
anesthetic mixture.
• The NCPAP Pres High flowmeter must be adjusted to zero when not required
for the patient.
• Under extreme conditions (minimum supply pressure and maximum gas
demand, including auxiliary output) output flow rates and delivered pressure
may be reduced.
• Only use the supplied AC cable to connect to the power supply.
• Do not attach the Generator to the patient until the initial set up is complete.
• The
indicates a connection between the transducer interface and the
unit. It does not indicate correct positioning of the Abdominal Respiratory
Sensor.
• Calibration must only be done when the unit is not connected to the patient.
• Ensure the whistle sounds during gas connection. If not, the device may be
faulty and should not be used. Refer to your Service Engineer.
• Verify that the displayed value for delivered FiO
corresponds to the value set
2
on the blender. Refer to Faults and Indications.
• Oxygen vigorously accelerates combustion. To avoid explosion hazard, do
not use any instrument or other equipment that may have been exposed to oil
or grease contamination.
675-120 Revision D May 2005
20 Infant Flow
Cautions
• Federal Law (USA) restricts this device to sale by or on the order of a
physician.
• The precision gas blender in this product may become non-functional or
damaged if used without the protective water trap and filters provided.
• The power switch on this unit does not isolate the external power supply.
Disconnect the power supply cable to ensure complete isolation.
• Before use, verify that this equipment has been authorized for use by a
qualified person.
• The Infant Flow SiPAP™ has been designed and tested as a complete
system using Infant Flow™ accessories. Only accessories approved for use
should be used. If in doubt, please contact your local VIASYS representative.
• Where the integrity of the external protective earth conductor is in doubt, the
equipment shall be powered by its internal power source (battery).
• Do not immerse any part of the IFSD in water or sterilize it with gas or steam.
®
SiPAP
• Ensure patient breathing circuit is replaced at regular intervals.
675-120 Revision D May 2005
Service Manual 21
675-120 Revision D May 2005
22 Infant Flow
Chapter 4: System Construction
CAUTION
Where the integrity of the external protective earth conductor is in doubt the
equipment shall be powered by its internal power source (battery).
The IFSD is AC powered with an integral rechargeable DC battery that provides
power for up to two hours without any interruption of performance or function. If the
AC power supply fails or is disconnected, the IFSD automatically switches to battery
power and gives an audio and visual alarm.
The IFSD is enclosed in a case with Operator controls and input connectors on the
front and rear panel. The front panel is shown in Figure 1. The back panel is shown
in Figure 2. The case incorporates non slip feet for table top use or must be fitted to
a dedicated stand. The major components within the casing are:
• a gas module
• an electronics module
®
SiPAP
• a front panel module
• a patient trigger module
• a firmware module
675-120 Revision D May 2005
Service Manual 23
Figure 1 - IFSD Front Panel
Gas Module
The function of the gas module is to take air and oxygen, blend them into the
required mixture and deliver this mixture to the patient at the prescribed flow rate.
The gas module also measures the oxygen concentration, m easures the patient
pressure, provides an auxiliary gas outlet (optional) and provides switched Biph asic flow.
The main components are an air/oxygen blend er, a f low manifold, a vent v alve, an
exhaust manifold with alarm whistle, NCPAP Pres low and NCPAP Pres high flowmeters,
and a valve/sensor PCB. The inlet gas connections are on an interchangeable inlet block
to allow for different gas fittings. The exhaust manifold discharges gas to the outside of
the case and is positioned away from the electrical connectors and switch to reduce any
potential explosive hazard.
675-120 Revision D May 2005
24 Infant Flow
Electronics Module
The function of the electronics module is to power the unit either by AC mains supply
or DC emergency battery supply, to control the gas module and read the gas module
sensors. The main components are a power supply unit, a rechargeable battery, a
main processor PCB, LED PCB, Valve/Sensor PCB and a LCD screen (touch
screen). The LCD screen includes a back-light which is always on when the IFSD is
powered. The touch screen displays information and receives inputs from the Operator
via the touch screen keyboard.
®
SiPAP
Figure 2 - IFSD Back Panel
Leak Test
Port
675-120 Revision D May 2005
Service Manual 25
Figure 3 -IFSD Internal Components
675-120 Revision D May 2005
26 Infant Flow
Front Panel Module
The function of the front panel module is to house the gas and electrical connections
to the patient, Operator controls and indicators. The module consists o f a front panel
plate, the touch screen with key pad, flowmeters and FiO
and indicators and an ambient light sensor. The backlight on the touch screen is
decreased if the ambient light sensor detects a low ambient light level and increased
if it detects a high ambient light level.
The green Power light is always on when AC power is connected to the unit.
control, patient connectors
2
®
SiPAP
The Alarm Warning Bar
Patient Trigger Module (Plus and Comprehensive Models)
The patient trigger module consists of a PCB which plugs into the main processor
PCB. Its function is to detect patient breaths a nd apne a and giv e this information to the
main processor in the electronics module. The main processor uses the signals from the
patient trigger module to instruct the biphasic pressure control to provide a timed sigh
to the patient.
Firmware Module
The firmware module is the unit’s embedded software. Its function is to instruct the
microprocessor how to control the unit and to interact with the Operator.
Touch Screen
The touch screen provides the Operator with a series of screens with icons to enable
settings, calibration and fault diagnosis. The Start Up Screen is shown in Figure 4.
The display includes a status bar which incorporates a battery status, mode
indicator, alarm button and patient trigger indicator. The center part of the display
shows icons which relate to the function being selected or perfo rmed. The display al so
includes a key pad with six keys. The icon in each key changes depending on the
function being performed.
flashes red to indicate an alarm.
Battery Status and Charging Indicator
If the battery status shows three bars or less, the display flashes alternately between
red bars on a white background and a pink background.
Alarm Button
The alarm button alerts the Operator to fault conditions. An audible alarm is activated
at the same time. In the unalarmed condition the button is green
high-priority alarm condition, the button flashes
alarm is heard. If the alarm button is pressed (to silence the audible alarm), the
button changes to
the button flashes
675-120 Revision D May 2005
and flashes red. In a medium-priority alarm condition,
yellow and an audible alarm is heard. In a low-priority
red and an audible
. In the
Service Manual 27
alarm condition, the button is solid yellow with an audible alarm. If any
alarm condition resets itself, the yellow alarm bar remains to alert the clinician of a
previous problem.
Caution/Information
The Caution/Information icon alerts the Operator to read this manual. It flashes
during an alarm condition.
Mode Indicator
The Mode Indicator shows four question marks when in Start up or Adjust and
changes to show the applicable mode in use (e.g. NCPAP).
Figure 4 - Touch Screen Display – Start Up
Patient Trigger Indicator (Plus and Comprehensive Models)
The Patient Trigger indicator changes to when the transducer interface is
connected and ready to be connected to the patient and indicates a
transducer interface is not connected.
when the
Alarm Conditions
Audible and visible alarm indications are given to alert the Operator to specified
conditions that affect the operation of the unit. The electronic alarm limits are
automatically set after two minutes without Operator inputs but the Operator can
manually set the alarm parameters for certain conditions if required. The IFSD has
the following alarms:
675-120 Revision D May 2005
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