Viasys Advance Infant Flow System User manual

Operator’s Manual

Infant Flow

Advance™ System

E.M.E. (Electro Medical Equipment) Ltd.
A subsidiary of VIASYS Healthcare inc.

© Copyright 2004, VIASYS Healthcare Critical Care

777077-101 Revision B June 2004

2 Infant Flow Advance™ System

Revision History

Date Revision Pages Changes

December 2003 A All Release

June 2004 B All Release manual in VIASYS Healthcare

template using VIASYS Healthcare Critical
Care nomenclature. Add Appendix C,
Abdominal Respiratory Sensor Placement.
Revise part number list in Appendix B.

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Operator’s Manual 3

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: [e-mail]
website: www.VIASYShc.com

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4 Infant Flow Advance™ System

CAUTION

Federal law (USA) restricts this device to sale by or on the order of a physician.

CAUTION

Not suitable for use in the presence of flammable anesthetics.

CAUTION

Always read the Operator’s Manual before applying treatment.

CAUTION

The Infant Flow Advance™ has been designed and tested as a complete system
using Infant Flow™ accessories. Use only approved accessories (Refer to Appendix
B for a list of approved accessories).

CAUTION

Service and/or repair of this instrument is restricted to VIASYS Healthcare authorized
or VIASYS Healthcare Trained Personnel only.

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Warranty

The Infant Flow Advance 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.

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Contents

Revision History....................................................................................2

Contact and Ordering Information ...............................................................................3

Warranty .........................................................................................................................5

Limitation of Liabilities....................................................................................................5

Contents .........................................................................................................................7

Chapter 1: Product Description ...........................................................9

Applications .................................................................................................................10

Intended Use ................................................................................................................10

Chapter 2: Product Specification.......................................................11

ETL Classification........................................................................................................13

EN 60601-1 Classification ...........................................................................................13

Chapter 3: Summary of Warnings and Cautions..............................15

Terms ............................................................................................................................15

Chapter 4: Operating Instructions.....................................................21

Step by Step Instructions............................................................................................22

Chapter 5: Clinical References...........................................................31

Chapter 6: Routine Maintenance........................................................33

Oxygen Analyzer Calibration......................................................................................33

Cleaning........................................................................................................................34

Battery Maintenance....................................................................................................34

Chapter 7: Summary of Symbols.......................................................37

Appendix A: Screen Flow Diagrams.................................................39

Appendix A: Screen Flow Diagrams.................................................39

Appendix B: Approved Accessories .................................................41

Appendix C: Abdominal Respiratory Sensor Placement.................43

Glossary of Terms...............................................................................45

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Chapter 1: Product Description

TM

The Infant Flow Advance
Analyzer, Flow meter and Pressure Manometer with integral alarm systems designed
specifically to be used in conjunction with the Infant Flow
generator, and patient interfaces consisting of a selection of masks and prongs.
Together these products make up the Infant Flow Advance System.

The Infant Flow Advance Driver is assembled in a sheet metal enclosure from
standard and commercial components. These are a Medical Air/Oxygen Blender, a
Flow meter calibrated for mixed gas between 0 and 15 L/min, a galvanic Oxygen
Fuel Cell with associated electronics, a self activating electronic pressure measuring
and limiting system and a power supply.

The Infant Flow Advance Driver is supplied with a pole mount bracket to fit round or
square section poles from 10 to 35 mm (0.4 to 1.4 in) diameter.

The Medical Air and Oxygen gas inlets are standard NIST, DISS or other appropriate
inlets. High-pressure Medical Air and Oxygen hoses must be ordered separately.

Driver is a combined Air/Oxygen Mixer, Oxygen

TM

nasal CPAP circuits,

The patient outlet is an ISO standard 15 mm female taper fitting and the pressure
monitoring inlet is a standard Luer taper fitting. The Oxygen monitor is an integral
part of the driver and does not require any additional external fittings.

The Oxygen monitor uses a galvanic fuel cell sensor which is fitted in a pressure
controlled path to avoid variations in delivered gas pressure altering the measured
value. The gas which is used for the Oxygen analyzer is subsequently vented from
the rear of the Infant Flow Driver.

The Infant Flow Advance™ Driver is designed to supply a periodic or patient­triggered additional flow of oxygen-enriched air to the patient, and to provide an
apnea monitoring and alarm facility when used in conjunction with the appropriate
accessories.

The Infant Flow Advance™ Driver can be used in the following modes:

• Nasal CPAP, via the Infant Flow generator, with or without apnea monitoring
using a respiration sensor that is attached to the patient’s abdomen.

• Pressure Assist (PA), whereby an elevated pressure is intermittently
delivered to the patient via the Infant Flow™ generator. This can be applied
at a variable rate (R) and for varying lengths of time (Ti) and with or without
apnea monitoring using a respiration sensor that is attached to the patient’s
abdomen.

• Triggered PA (trPA), whereby an elevated pressure is intermittently delivered
to the patient via the Infant Flow™ generator. This is triggered by the
patient’s own respiratory effort by using a respiration sensor that is attached
to the patient’s abdomen and for varying lengths of time (Ti). Apnea
monitoring is a feature of this mode and a back-up rate (Rb) is available.

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Applications

Applications are prescribed by the clinician depending on the needs of the patient.

Intended Use

The Infant Flow Advance System consisting of a driver and generator plus nasal
CPAP prongs and masks, is intended for the provision of periodic and patient
triggered bi-Level CPAP. The system is for use in hospitals, hospital-type facilities
and intra-hospital transport environments.

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Chapter 2: Product Specification

This manual describes the operation and routine maintenance of the M674 models of
the Infant Flow Advance™ Driver when fitted with Version 1.00 software and above.
Identification of the particular version of software fitted in the equipment may be
made at power-up. When the Infant Flow Advance Driver is turned on, the 7 segment
displays show first three "8"s, then blanks, then the software version number as part
of the start-up procedure.

• Gas supply - Nominal 50 PSI (3.5 bar) clean, dry Medical Air and Oxygen.

• Range - Minimum 30 psig (2.1 bar), maximum 80 psig (5.6 bar). Maximum

differential pressure 30 psig (2.1 bar).

• Power Supply – 95-135 Vac, 0.30A, 50-60 Hz or 200-265 Vac, 0.15A,
50-60 Hz. Internal lead acid battery (2 hours running time when fully
charged).

CAUTION

Equipment must be used with approved power supplies. Refer to Appendix B for a
list of approved accessories.

• Power and Battery status indicators – indicates connection to an external
power source and the battery status.

- Top indicator shows green when an external 12V DC power source is

connected and indicates the battery is being charged.

- The full battery indicator shows green when the battery is fully charged.

- The low battery indicator shows red when the battery is low. With this

LED illuminated, approximately 15 minutes of power remain before a
complete discharge of the battery occurs.

• Dimensions: 11in (27.5 cm) x 8.5 in (22.25 cm) x 5.5 in (13.75 cm)
(excluding gas inlets, patient outlets and mounting bracket)

• Weight: 16 lbs (7.2 kg)

• Air/Oxygen Mixer - Range 21 to 100% Oxygen, accuracy ± 3% of selected

output

• Flow meter - Range 0 to 15 L/min, accuracy ± 5% of selected output

• Pressure relief valve - 2 systems incorporated

- Patient safety - automatic electronic valve system pre-set to vent to

ambient at 11 cmH2O.

- System and delivery circuit safety - mechanical internal relief valve pre-

set at 205 cmH2O.

• Manometer - Range, 0 to 12 cmH

• Oxygen Monitor – Range, 0 to 100% Oxygen, accuracy ± 2% of span.

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O, accuracy ± 1 cmH2O.

2

12 Infant Flow Advance™ System

• Alarm System - Four separate alarm systems are provided all of which are
automatic. The electronic alarms are set after 2 minutes of operation without
operator intervention although the operator can manually set or reset them if
required.

1 Supply gases failure: If the differential pressure between the two inlet

gases falls outside of the limit of 20 PSI (1.4 bar) or one gas fails
completely, an alarm will sound and the gas at the higher pressure only
will be delivered to the patient.

2 High patient pressure: An audible and visual high pressure alarm is

pre-set at 11 cmH
relieving solenoid which instantly reduces the pressure in the patient
circuit to near zero. The pressure is restored after 3 seconds, but will be
reduced to near zero should the cause of the alarm condition still exist. A
second high pressure alarm with audible and visual indication is set 3
cmH

O above the measured CPAP pressure.

2

3 Low patient pressure: An audible and visual low pressure alarm is set

at 2 cmH

O below the measured CPAP pressure or at 0 cmH2O if this

2

would otherwise be negative.

4 Failure to deliver correct Oxygen concentration: Audible and visual

alarms are provided at ± 5% of the measured FiO
of the alarms with an upper maximum limit of 101% and a lower
minimum limit of 20%. There is a low hazard warning at 18% Oxygen or
below. Additionally, the Infant Flow Advance has the following
characteristics:

O. This alarm automatically activates a pressure

2

at the time of arming

2

• Variable augmented flow: 0 to 5 L/min of the mixed gas

• Pressure display with time: 0 to 10 cm H

O; accuracy: 10% of full

2

scale

• Timing accuracy: 1% of setting

• Input connection: 8-way self-locking socket for Transducer Interface

• Apnea alarm indicator (red)

• Breath indicator (yellow) – indicates inspiration when the Transducer

Interface and abdominal respiratory sensor are properly fitted.

• Environment: Keep dry and do not expose to direct sunlight.

- Temperature
Operating: 50 to 104 ºF (10 to 40 ºC)

Storage: 32 to 122 ºF (0 to 50 ºC)

- Humidity
Operating : <90% non condensing
Storage: <90% non condensing

- Atmospheric Pressure
Storage: 8.7 to 20.3 PSI (0.6 to 1.4 bar)

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Operator’s Manual 13

ETL Classification

With respect to applicable requirements of Standard for Safety Medical Electrical
Equipment, UL 60601-1 1
General Instructions No. 1, CAN/CSA C22.2 No. 601.1-M90.

st

Ed. 04/25/03 and General Requirements for Safety

EN 60601-1 Classification

Equipment is Class 1 and internally powered, IPX0 Protected, and uses Type B and
Type BF applied parts.

Equipment not suitable for use in presence of flammable anesthetics.

NOTE

For use of Model M674A in Australia and New Zealand, Power supply Part Number
777223 must be used. This replaces Power Supply 674-037. With Power Supply Part
Number 777223 in use, M674A equipment is Class 2 and internally protected, and
uses Type B applied parts.

NOTE

Although the Infant Flow™ Advance meets the requirements of current EMC/RFI
legislation, this does not guarantee immunity from all sources of radiated energy.
Some mobile telephones and other products containing radio transmitting
components may cause malfunction of the Infant Flow™ Advance and should not be
used in the vicinity of the device.

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