Infant Flow SiPAP Service Manual 3rd Edition Ver A

Infant Flow SiPAP ™

Third Edition Service Manual

33199-001 Version A (2021-11)

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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 Vyaire Medical, Inc. 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. Trademarks are the property of their respective owners. © 2021 Vyaire. Vyaire, the Vyaire logo, and Infant Flow are trademarks or registered trademarks of Vyaire Medical, Inc., or one of its affiliates.

Manufactured by

Authorized Representative in the European Community

Vyaire Medical, Inc. 26125 North Riverwoods Blvd. Mettawa, IL 60045, U.S.A. 1-833-327-3284

EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands

[email protected] www.vyaire.com

Technical and clinical support 1-800-231-2466 [email protected] After hours service: 1-800-231-2466 from within the United States Customer care helpline 24 hours, seven days a week 1-800-231-2466 from within the United States Product, accessories, and parts ordering 1-833-327-3284 [email protected]

33199-001 Version A (2021-11)

Australian Sponsor: Vyaire Medical Pty Ltd Suite 5.03, Building C Foundation Park 7-11 Talavera Road Macquarie Park, NSW, 2113 Australia

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Contents Chapter 1:

Product description ...1

Infant Flow™ SiPAP features ...1 Product configurations ...2 Chapter 2:

Product specifications ...5

Modes ...5 Controls ...5 Monitored parameters ...5 Pneumatic supply ...5 Electrical supply ...6 Ingress protection ...6 Isolation ...6 Atmospheric and environmental ...7 Physical ...7 Silencer/filter ...7 SiPAP gas monitor ...7 Button symbols ...11 Chapter 3:

System construction ...13

Gas module ...15 Electronics module ...15 Front panel module ...18 Patient trigger module ...18 Firmware module ...18 Touchscreen ...18 Alarm conditions ...22 Diagnostic screen ...22 Chapter 4:

Theory of operation ...25

Gas flow ...25 Electronic functions ...27 Electrical wiring and PCB connector layout...28 Fault management ...29 Chapter 5:

Operational setup ...31

Preparing and connecting the equipment...31

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iv Switching on the SiPAP ... 34 Setting up the equipment ... 35 Chapter 6:

Operational verification test... 43

Required equipment ... 43 OVP procedure ... 43 Power-on check ... 43 Two-point O2 sensor calibration ... 44 Leak test ... 45 Blender test ... 47 Alarms test ... 47 Infant Flow™ SiPAP user verification test checklist ... 49 Chapter 7:

Faults and indications ... 51

Fault indications ... 51 Diagnostics and error codes ... 58 Chapter 8:

Preventative maintenance ... 67

Maintenance frequencies ... 67 Tools required ... 67 Cleaning ... 67 Preventative maintenance procedure ... 68 Chapter 9:

Disassembly and reassembly ... 71

Removal and fitting of parts – general ... 71 Power cord ... 71 Case/cover ... 71 Battery ... 73 Oxygen filter ... 75 Oxygen filter/restrictor ... 76 Oxygen sensor ... 77 Front panel and blender ... 78 Water trap filter... 81 Pilot drive check valves ... 82 Case bleed filtered restrictor and muffler ... 82 Valve/sensor PCB ... 83 Appendix A: RS232 communications... 85

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v Appendix B: Oxygen leak test ...87 Appendix C: Spare parts ...89 Appendix D: Pneumatics assembly ...91 Appendix E: Glossary ...93

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Warranty The Infant Flow™ 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 Vyaire Medical, Inc., (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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Notices 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.

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. Please refer to electromagnetic environment specifications below.

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.

Electromagnetic environment specifications Guidance and manufacturer’s declaration – electromagnetic emissions SiPAP is intended for use in the electromagnetic environment specified below. The customer or the user of SiPAP should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2

Compliance Group 1

Class A

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

Electromagnetic environment – guidance SiPAP uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. SiPAP Infant Flow is suitable for use in all establishments other than domestic, and it may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: The SiPAP Infant Flow is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the SiPAP system or shielding the location.

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Guidance and manufacturer’s declaration – electromagnetic immunity SiPAP is intended for use in the electromagnetic environment specified below. The customer or the user of SiPAP should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

±1 kV for input/output lines

±1 kV for input/output lines

Surge

±1 kV differential mode

±1 kV differential mode

±2 kV common mode

±2 kV common mode

<5 % UT

<5% UT

(>95 % dip in UT) for 0,5 cycle

(>95 % dip in UT) for 0.5 cycle

40% UT

40% UT

(60 % dip in UT) for 5 cycles

(60% dip in UT) for 5 cycles

70% UT

70% UT

(30 % dip in UT) for 25 cycles

(30% dip in UT)

<5% UT

<5% UT

IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

(>95% dip in UT) for 5 s Power frequency (50/60 Hz) magnetic field

3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

for 25 cycles (>95% dip in UT) for 5 s 3 A/m

Magnetic fields should be that of a typical commercial or hospital environment.

IEC 61000-4-8 NOTE

U T is the a.c. mains voltage before application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity SiPAP is intended for use in the electromagnetic environment specified below. The customer or the user of SiPAP should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of SiPAP, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 V rms

Radiated RF IEC 61000-4-3

3 V/m

3 V rms

d = 1,2√P

3 V/m

d = 1,2√P

80 MHz to 800 MHz

d = 2,3√P

800 MHz to 2,5 GHz

150 kHz to 80 MHz

80 MHz to 2,5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as detera mined by an electromagnetic site survey, should be less than the compliance level in each frequency b range. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixe d RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SiPAP is used exceeds the applicable RF compliance level above, the SiPAP should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SiPAP.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between portable and mobile RF communications equipment and SiPAP SiPAP is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of SiPAP can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and SiPAP as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter M 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = 1,2√P

d = 1,2√P

d = 2,3√P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Intended use notice The Infant Flow nCPAP System, consisting of the Infant Flow SIPAP Driver and Generator Assembly plus nCPAP prongs and masks, is intended for the provision of nasal CPAP and BiPhasic CPAP (SiPAP) to produce a sigh. Nasal CPAP should only be used on a spontaneously breathing infant. The system is for use in hospitals, hospital-type facilities, and intra-hospital transport environments and is indicated for the treatment of newborn and infant patients. The Infant Flow SiPAP driver should only be operated by properly trained clinical personnel, under the direction of a physician.

Contraindications for use notice This device cannot detect obstructive apnea. Do not attempt to use this device to detect obstructive sleep apnea.

Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician. Reuse of single-patient use accessories may degrade the performance of the product or cause cross contamination.

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Classification Type of Equipment: • • • •

•

Medical Equipment Class 1 and internally powered IEC 60529 IPX1 Protected This equipment uses type BF applied parts (patient end of the patient circuit, generator, patient interface, transducer interface, and transducer abdominal sensor). Reference “Appendix C: Spare parts” on page 89 for parts and accessories. This equipment is not suitable for use in presence of flammable anesthetics.

System components • • • • • •

Infant Flow SIPAP Driver Generator Assembly plus nCPAP prongs and masks Patient circuits Transducer interface and transducer abdominal sensor Support stand/cart RS232 connected equipment (IEC60950 compliant)

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Standards The Infant Flow driver and essential accessories manufactured or provided by Vyaire Medical, Inc., comply with the following standards and regulatory requirements. IEC 60601-1Edition 2.0 (EN 60601-1:1990 + A1:1993 + A2:1995 + A11:1993 + A12:1993)–Medical electrical equipment Part 1: General requirements for basic safety. IEC 60601-1:2005 +A1:2012 Edition 3.1 (EN 60601-1:2005)–Medical electrical equipment– Part 1: General requirements for basic safety and essential performance. IEC 60601-1-8:2003; A1:2006–Medical electrical equipment–Part 1-8: General requirements for safety– Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. IEC 60601-1-8:2006 + A1:2012 (EN 60601-1-8:2007 + A1:2013)–Medical electrical equipment–Part 1-8: General requirements for safety–Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. CSA Z5359–Low-pressure hose assemblies for use with medical gases. ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors ISO 5359:2008/Amd 1:2011–Low-pressure hose assemblies for use with medical gases. EMC IEC 60601-1-2:2007–Medical electrical equipment–Part 1-2: General requirements for basic safety and essential performance–Collateral standard: Electromagnetic compatibility–Requirements and tests. Packaging ISTA 2A: 2008 Series Partial-Simulation Performance Test Procedure. Packaged-Products 150 lb (68 kg) or less IEC 60529:2001 Ed. 2.1 Degrees for protection provided by enclosures (IP Code).

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Warnings and cautions Please review the following safety information before operating the Infant Flow SiPAP driver. 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, operation, or maintenance of the device, contact Vyaire Medical, Inc., (see page ii). Terms

WARNING

Warnings identify conditions or practices that may result in serious adverse reactions or potential safety hazards.

CAUTION

Cautions identify conditions or practices that may result in damage to the device or other equipment.

NOTE

Notes identify supplemental information to help you better understand how the device works. Warnings Read the following list of warnings before using this instrument. • • • • • • • • • • • • • •

Infant Flow SiPAP driver is intended for use by a trained practitioner, under the direct supervision of a qualified physician. When the Infant Flow SiPAP driver is connected to a patient, a trained health care professional should be in attendance at all times in order to react promptly to an alarm or other indications of a problem. Do not operate the Infant Flow SiPAP with dry unheated gas. No modification of this equipment is allowed. Always have an alternate means of ventilation available whenever the Infant Flow SiPAP driver is in use. Do not attach the generator to the patient until the user verification procedure and initial setup into the nCPAP mode are complete. Water in the air supply can cause this equipment to malfunction. Check the water trap at least every 24 hours (more frequently if needed, depending on amount of water in the air supply). Do not touch the electrical connectors of the Infant Flow SIPAP driver or its accessories, and the patient simultaneously. Do not use a multiple socket outlet or an extension cord when using the Infant Flow SiPAP. An audible alarm indicates an anomalous condition and should never go unheeded. Antistatic or electrically conductive hoses or tubing should not be used within the patient circuit. If a mechanical or electrical problem is recognized while operating the Infant Flow SiPAP driver, it must be removed from use and referred to qualified service personnel for servicing. Using inoperative equipment may result in patient injury. Before 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. symbol indicates a connection between the transducer interface and the driver. It does not The indicate attachment or correct positioning of the abdominal respiratory sensor.

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Under certain conditions (minimum supply pressure and maximum gas demand, including auxiliary output) output flow rates and therefore pressure delivered to the generator may be reduced. The Pres High flow meter may be adjusted to zero when the BiPhasic mode is not required for the patient.

NOTE

To deliver manual breaths, the Pressure High flow meter must indicate a flow that is above zero. •

• • • • •

• • • • • • • • • • • • • • • •

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 alarm conditions may require immediate attention. Nasal CPAP therapy in general can cause nasal irritation, septal distortion, skin irritation and pressure necrosis. Adherence to the recommended usage instructions for the Infant Flow nCPAP System and AirLife™ Infant nCPAP System may reduce the incidence of these complications. We strongly recommend that regular monitoring for gastric distention be carried out for patients receiving noninvasive support. Refer to your facility’s policy and procedure for further guidance. Oxygen vigorously accelerates combustion. To avoid explosion hazard, the Infant Flow SiPAP should be operated in a well-ventilated environment. Do not to position the Infant Flow SiPAP so that it is difficult to disconnect the power cord from the wall outlet. This device exhausts O2 during normal operation. Oxygen vigorously accelerates combustion. To avoid fire hazard, do not place flammable materials or sources of heat close to the exhaust. The Abdominal Respiratory Sensor is used only to enable features associated with certain modes from the Infant Flow SiPAP driver. When using the Abdominal Respiratory Sensor, always use an additional, external device for monitoring of the respiratory rate and detection of apneic episodes as well as an appropriate monitor for continuous SaO2 monitoring. Always use an additional, external device for monitoring respiration and oxygenation when using the Infant Flow SiPAP. If the Infant Flow SiPAP driver is shelf mounted, ensure that the driver is stable and that all circuit tubing, hoses and cables are restrained to avoid hazard of toppling and disconnection. If a patient water trap is to be used, empty it before using it, and empty it frequently during use (at least every hour). Empty the water trap according to approved, hospital procedures. Do not block or restrict the exhaust port located on the instrument back panel. Equipment malfunction may result. Do not use the equipment without the expiratory tubing connected to the generator. Use only the supplied AC cable to connect to the power supply. The Transducer LED indicator on the front panel of the driver only signifies connection to the driver. It does not indicate connection to or proper positioning of the Abdominal Respiratory Sensor. Do not overload the pole and stand. Face the Infant Flow SiPAP driver when moving it on the stand. This is the safest transport position for the unit. 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. When a low gas supply alarm occurs, the oxygen concentration delivered to the patient will differ from that set on the %O2 control. A source gas failure will change the FiO2 and may result in patient injury. The functioning of this equipment may be adversely affected by the operation of other equipment nearby, such as high frequency surgical (diathermy) equipment, defibrillators, short-wave therapy equipment, two-way radios, or cellular phones. The Infant Flow SiPAP is not equipped with automatic barometric pressure sensor. Due to possible explosion hazard, the Infant Flow SiPAP driver should not be used in the presence of flammable anesthetics. Electric shock hazard-do not remove any of the Infant Flow SiPAP driver covers or panels. Refer all servicing to an authorized Vyaire Medical, Inc., service technician or factory trained technician.

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• •

• • • • • • • • • • •

A protective ground connection by way of the grounding conductor in the power cord is essential for safe operation. Upon loss of protective earth ground, all conductive parts including knobs and controls that may appear to be insulated can render an electrical shock. To avoid electrical shock, plug the power cord into a properly wired receptacle, use only the power cord supplied with the device, and make sure the power cord is in good condition. To avoid the risk of electric shock, the Infant Flow SiPAP should be connected to a supply main with protective ground (earth). The Infant Flow SiPAP driver is designed to ensure that the user and patient are not exposed to excessive leakage current according to applicable standards. However, this cannot be guaranteed when external devices are attached to the driver. In order to prevent the risk of excessive enclosure leakage current from external equipment attached to the driver, isolation of the protective earth paths must be provided to ensure proper connection. This isolation should ensure that the cable shields are isolated at the peripheral end of the cable. When the Infant Flow SiPAP driver is connected to a patient, and the internal oxygen monitor is disabled, the Infant Flow SiPAP driver must be used with an external oxygen monitor. To ensure a full battery charge, the Infant Flow SIPAP driver should be plugged into an AC outlet when not in use. Always disconnect the infant from the Infant Flow SiPAP driver, before turning off the SiPAP device and disconnection from gas source. Before use, ensure the Infant Flow SiPAP driver is situated where no injury could arise as a result of the device over-balancing or falling. Before use, ensure that that all cables, tubes and the stand are situated away from walkways. When power is lost for less than or equal to 30 seconds, the ALARM SETTINGS before the power loss are restored automatically. Used disposable circuits and accessories are considered a Biohazard and should be disposed of as contained waste. Always monitor patient temperature when connected to neonatal/infant patients. Never service the SiPAP unit in the patient environment. Do not connect a SiPAP unit that does not have a cover installed to a patient. Do not modify the SiPAP driver. Cautions

Read the following list of cautions before using this instrument. • • • • • •

• • • •

Before use, verify that this equipment has been authorized for use by qualified technical service personnel. Ensure that the voltage and installed fuses are set to match the voltage of the wall outlet, or damage may result. A battery that is fully drained (that is, void of any charge) may cause damage to the driver and should be replaced. All accessory equipment that is connected to the driver should comply with IEC60601-1. The Infant Flow SiPAP driver meets IEC 60601-1-2 test levels and use of the unit in an environment outside of these values may cause abnormal operation or unit degradation. Although failure of any of the operational verification tests do not prevent the Infant Flow SiPAP driver from functioning, the unit should be checked to make sure it is operating correctly before use on a patient. (See “Chapter 6: Operational verification test” starting on page 43 for the operational verification test procedures.) The Infant Flow SiPAP driver has been designed and tested using only Vyaire Medical, Inc., accessories. Only use accessories, preventative maintenance kits, and repair parts approved by Vyaire Medical, Inc. If in doubt, contact your local service representative. Employ safe lifting procedures when assembling the unit. Do not sterilize the driver. The internal components are not compatible with sterilization techniques. Do not submerge the SiPAP driver, spray the driver with liquid, or pour cleaning liquids over or into the driver.

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Following each alarm verification test, ensure that control settings and alarm limits are reset as instructed before proceeding to the next test. Only use power cords supplied by Vyaire Medical, Inc. Failure to use Vyaire Medical, Inc., parts may result in loss of electrical or mechanical safety in unanticipated ways during operation. If the Infant Flow SiPAP is turned off or if the battery is depleted, the current patient settings will be lost. The Infant Flow SiPAP will return to the default settings when turned back on. If the patient pressure is inconsistent with set flow, be aware of possible leaks, connection faults or occlusion. Monitor the breathing circuit for excessive condensation and drain and replace circuit as necessary. Vyaire Medical, Inc., cannot ensure product performance as stated in this manual with the use of accessories not provided by Vyaire Medical, Inc. The stand can be transported in any direction, but for the purposes of parking the unit on a grade, the three locking wheels must be facing downhill. Do not lean on the SiPAP unit or stand, because doing this may cause them to tip over. Do not push or pull on the SiPAP unit to move the stand, because doing this may cause the stand to tip over. Use the stand handle for moving the stand.

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Chapter 1:

Product description

The Infant Flow SiPAP driver systems are non-invasive forms of respiratory support designed for use on infants 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 driver is available in the 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 driver comes standard in all configurations with an LCD touchscreen display, pressure time waveform graphics, integrated patient monitoring, alarms for high and low pressure and FiO2 and up to 2 hours of backup battery power. As a result of the unique, patented design, the Infant Flow, Infant Low LP or AirLife™ Infant nCPAP System Generators have 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 systems 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 Vyaire Medical, Inc. These accessories include circuits and generators, prong and mask patient interfaces and bonnets. * Comprehensive configuration is not available for sale in the United States

Infant Flow™ SiPAP features The expanded capabilities of the Infant Flow SiPAP Plus and Comprehensive* configurations allow applications to a broader range of patients who may otherwise not be candidates for non-invasive respiratory support from NCPAP alone. 1, 2 NCPAP. Continuous positive airway pressure based on clinician set pressure. Breath rate monitoring/alarm can be activated in this mode. BiPhasic. time triggered pressure assists are delivered based on clinician set Time-High, rate and pressure criteria. Apnea monitoring/alarm can be activated in this mode. BiPhasic tr*. patient triggered pressure assists delivered based on clinician set Time-High and pressure criteria. Apnea monitoring/alarm and apnea backup breaths are automatically active in this mode. Infant Flow , Infant Flow LP or AirLife Infant nCPAP System 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. 3 Fully integrated alarm package. 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 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. 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 access to controls. 1 A Prospective Randomized, Controlled Trial Comparing Synchronized Nasal Intermittent Positive Pressure Ventilation versus

Nasal Continuous Positive Airway Pressure as Modes of Extubation. Khalaf Nabeel, M., Brodsky Nancy, Hurley John, Bhandari Vineet. PEDIATRICS 108 (1): 13-17: 2001 2 Efficacy of Nasal Intermittent Positive Pressure Ventilation in Treating Apnea of Prematurity. Lin Chyi-Her, MD, Wang Shan-Tair, PhD, Lin Yuh-Jyh, MD, Yeh Tsu-Fuh, MD:PediatricPulmonology: 26 (5): 349-53; 1996 3 Decreased imposed work with a new nasal continuous positive airway pressure device. Klausner, James F., PhD, Lee, Amy., Hutchison, Alastair A., FRACP. Pediatric Pulmonology 22: 188-194; 1996

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Chapter 1: Product description

Product configurations Table 1-1. Non-U.S. configuration parameters Parameter

Min

Max

Accuracy

Units

Default

Set Oxygen concentration, %O2

21

100

±3 (≥ 3 L/min)

%

n/a

nCPAP / Pres Low flow rate

0

15

±15%

L/min

n/a

Pres High flow rate

0

5

±15%

L/min

n/a

Main and Auxiliary Outlet

0

30

n/a

L/min

n/a

BiPhasic / BiPhasic tr* on time, T-High

0.1

3.0

±0.005

seconds

0.3 sec

BiPhasic rate, R (mandatory rate)

1

120

±0.5

bpm

30 bpm

BiPhasic tr* backup rate, Rb (apnea backup rate)

1

120

±0.5

bpm

10 bpm

Apnea timeout, Tapnea

10

30

±1

seconds

20 sec

Note: BiPhasic tr mode not currently available in the United States. In non-US configurations, T-High automatically reduces at higher R and Rb rate settings to maintain a minimum off time of 100 milliseconds. Table 1-2. U.S. configuration parameters Parameter

Min

Max

Accuracy

Units

Default

Set Oxygen concentration, %O2

21

100

±3 (≥ 3 L/min)

%

n/a

nCPAP / Pres Low flow rate

0

15

±15%

L/min

n/a

Pres High flow rate

0

5

±15%

L/min

n/a

Main and Auxiliary Outlet

0

30

n/a

L/min

n/a

BiPhasic on time, T-High

0.1

3.0 *

± 0.005

seconds

1.0 sec

BiPhasic rate, R (Mandatory rate)

1

54

±0.5

bpm

10 bpm

Apnea timeout, Tapnea

10

30

±1

seconds

20 sec

Note: In U.S. configurations, T-High automatically reduces at higher R and Rb rate settings to maintain a minimum off time of 1.0 seconds.

33199-001 Version A (2021-11)

Chapter 1: Product description

3

Table 1-3. Functions Functions

Plus

Comprehensive*

nCPAP

•

•

nCPAP with Apnea monitoring and alarm

•

•

BiPhasic

•

•

BiPhasic with Apnea 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

33199-001 Version A (2021-11)