CareFusion Infant Flow SiPAP User manual

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Infant Flow® SiPAP™

Operator’s manual

ii Infant Flow

SiPAP™

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

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

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

© 2009–2010 CareFusion Corporation or one of its subsidiaries. All rights reserved. Infant Flow is a registered trademark and SiPAP is a trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners.

USA

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

Authorized European Representative

CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany District Court Wuerzburg HRB7004

800.231.2466 tel +1.714.283.2228 tel

+49.931.4972.0 tel

+49.931.4972.423 fax

+1.714.283.8493 fax

carefusion.com

Literature number: 675–101–101 Revision K

675–101–101 Rev. K

Infant Flow® SiPAP™ iii

R evision History

Date Revision Changes

September 2003 675-101(3) Release

August 2004 D Release manual in VIASYS Respiratory Care template using

VIASYS Respiratory Care nomenclature. Revise part number list in Appendix B approved accessories.

November 2004 E

March 2005 F Updated the contact information.

May 2006 G Updated the company name.

Revised contact/ordering information.

Ch 4. Sec. 5.b revised transducer LED illumination conditions.

Appendix A corrected units from "Pm" to bpm.

Appendix E added dimension ranges to bonnet sizes.

Appendix E Was 467350 Transducer Assembly Is: 677-002 Transducer Interface.

Updated the Declaration of Conformity Notice.

Updated the Contact and Ordering Information.

Update the figures.

Added a Caution regarding back pressure. Added a Note regarding the Hudson RCI Humidification System.

Added the sentence “Ensure there is a minimum 8 LPM set

on the NCPAP/PRES Low Flow meter”

under “Two Point O

Changed step 8 regarding the nCPAP pressure.

Changed the second and third paragraphs under Changing a Control.

Sensor Calibration.

to the first paragraph

Added “Setting a Manual Breath.”

Added a note regarding the enabling of manual breath or backup apnea breath.

Added a warning concerning infant flow consumables.

Added the statement “Disconnect the air and oxygen gas sources when the Infant Flow SiPAP

Removed Appendix E.

February 2009 H Changed Ti to T-High and Inspiratory Time to Time High.

Replaced reference to VIASYS Respiratory Care accessories with reference to Cardinal Health accessories.

Added “TM” superscript to “SiPAP”.

Added reference to AirLifeTM Infant nCPAP System Generator.

Removed “inspiratory time” or “inspiration time”.

Replaced “Inspiratory Time (Time High)” with “Time High

675–101–101 Rev. K

™ is not in use.”

iv Infant Flow

Date Revision Changes

(Thigh)”

Changed 1 cmH2O to 1.5 cmH2O; Added “or 60 psi” to clarify 4 bar.

Added the parts list for both Infant Flow® Products and AirLifeTM Products.

Added reference to Cardinal Health contact information on page v.

Added reference to AirLifeTM Infant nCPAP System accessories.

Added a warning about using an external oxygen monitor. Added reference to factory trained technician and Service

Manual P/N 675-120.

Added “®” (registered symbol) superscript to Infant Flow.

Updated CAUTION label: from “Back pressure from the humidifier chamber to some auto-feed water bags may occur.” To “Back pressure from some auto-feed humidifier chambers may cause the water bags to fill with air.”

SiPAP™

Replaced Figure 5.

Add content concerning a depleted or damaged internal oxygen cell.

Added a warning about using an external oxygen monitor. Added content to explain fault code E5X.

Replaced “key” with “button”; clarified oxygen alarm by adding “the audible”; added clarification of the internal monitoring being disabled and that an external oxygen monitor must be used.

Added a Note regarding the 2nd Flow Meter being used for manual breath delivery;

Added hyphen in “T-High”.

Clarified the “Mode Select Screen”

Added “Directions for using the AirLifeTM Infant nCPAP System.

Changed 1 cmH2O to 1.5 cmH2O; Corrected low battery voltage level from 10 to 11.10.

Added “or trained biomedical engineer”.

Added a table entry for the oxygen monitor and alarms disable.

Changed 1 cmH2O to 1.5 cmH2O; corrected low battery voltage level from 10 to 11.10.

Updated Table 10.

Updated Table 11.

Clarified the meaning of T-High.

February 2010 J Revised to comply with the revised Medical Device Directive

2007/42/EC.

675–101–101 Rev. K

Infant Flow® SiPAP™ v

Date Revision Changes

March 2010 K Rebranded the manual to the CareFusion style.

Updated the part number table.

675–101–101 Rev. K

vi Infant Flow

Warranty

Infant Flow® SiPAPTM 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 CareFusion (referred to as the Company) under this warranty is limited to replacing, repairing or issuing credit, at the discretion of the Company, for parts that become defective or fail to meet published specifications during the warranty period; the Company will not be liable under this warranty unless (A) the Company is promptly notified in writing by Buyer upon discovery of defects or failure to meet published specifications; (B) the defective unit or part is returned to the Company, transportation charges prepaid by Buyer; (C) the defective unit or part is received by the Company for adjustment no later than four weeks 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.

SiPAP™

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.

675–101–101 Rev. K

Infant Flow® SiPAP™ vii

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

Warranty .................................................................................................................... vi

Contents ................................................................................................................... vii

List of Figures .......................................................................................................... viii

List of Tables ........................................................................................................... viii

Notices ....................................................................................................................... ix

Chapter 1 - Product Description ................................................................................. 1

Chapter 2 - Product Specifications............................................................................. 3

Chapter 3 - Summary of Warnings and Cautions....................................................... 7

Chapter 4 - Unpacking & Setup ............................................................................... 11

Chapter 5 - Operation .............................................................................................. 23

Chapter 6 - Operating Modes .................................................................................. 33

Chapter 7 - Alarms and Indicators ........................................................................... 35

Chapter 8 - Maintenance & Cleaning ....................................................................... 41

Chapter 9 – Explanation of Symbols ........................................................................ 43

Appendix A - Product Configurations ....................................................................... 49

Appendix B - Pneumatic Diagram ............................................................................ 51

Appendix C - Alarm Troubleshooting ....................................................................... 53

Appendix D - Fault Management ............................................................................. 57

Glossary ................................................................................................................... 63

Index ........................................................................................................................ 65

675–101–101 Rev. K

viii Infant Flow

List of Figures

Figure 1 – Stand unpacking and assembly ........................................................ 11

Figure 2 – Stand and Driver assembly ............................................................... 12

Figure 3 – Driver assembled with patient circuit and /humidifier ........................ 13

Figure 4 – Attaching the Abdominal Respiratory Sensor ................................... 14

Figure 5 – Flow Pressure Nomogram ................................................................ 15

Figure 6 – Front Panel ....................................................................................... 23

Figure 7 – Rear Panel ........................................................................................ 24

Figure 8 – Set Up Screen .................................................................................. 27

Figure 9 – Alarm set/confirm Screen ................................................................. 28

Figure 10 – Mode Select Screen ....................................................................... 29

Figure 11 – Parameter Adjust Screens .............................................................. 29

Figure 12 – Main Screen .................................................................................... 30

SiPAP™

Figure 13 – Monitored Parameters Screen ........................................................ 30

Figure 14 – NCPAP ........................................................................................... 33

Figure 15 – BiPhasic .......................................................................................... 33

Figure 16 – BiPhasic tr....................................................................................... 34

Figure 17 - Flat Battery screen .......................................................................... 37

List of Tables

Table 1 – Functions and Accessories .................................................................. 2

Table 2 - Soft-key operation ............................................................................... 25

Table 3 – Parameter Default Value .................................................................... 27

Table 4 – Alarm Symbols and Indicators ........................................................... 38

Table 5 – Equipment Symbols ........................................................................... 43

Table 6 – Button Symbols .................................................................................. 45

Table 7 – Non-US Configuration Parameters .................................................... 49

Table 8 – US Configuration Parameters ............................................................ 49

Table 9 – Alarm Troubleshooting ....................................................................... 53

Table 10 – Fault Classification ........................................................................... 57

Table 11 – Fault Recovery ................................................................................. 58

675–101–101 Rev. K

Infant Flow® SiPAP™ ix

Notices

E MC Notic e

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

Electrical Safety:

Class 1 equipment

Contains type BF patient applied parts

Continuous Operation

MR I 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 intended for the provision of Bi-Level CPAP (SiPAP™) to produce a sigh. 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 personnel, under the direction of a physician.

SiPAP™ should only be operated by properly trained clinical

675–101–101 Rev. K

x Infant Flow

R egulatory 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.

Clas sification

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.

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:

EN60601-1 and EN60601-1-2 EN 10993 EN 14971

SiPAP™

EU Notified Body:

BSI (Reg. No. 0086)

Trade names:

Infant Flow

SiPAP™

Manufactured by:

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

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

675–101–101 Rev. K

Infant Flow® SiPAP™ 1

Chapter 1 - Product Description

Infant Flow® SiPAP™ provides a non-invasive form of respiratory support designed for infants in hospital environments such as Neonatal and Pediatric Intensive Care Units. It can also be used when transporting these patients within the hospital environment.

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 a patient triggered BiPhasic mode with apnea backup breaths. The Infant Flow LCD touch screen display, pressure time waveform graphics, integrated patient monitoring, alarms for high and low pressure and FiO battery power.

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

SiPAP™ is currently available in a Plus or Comprehensive*

SiPAP™ comes standard in all configurations with an

and up to 2 hours of backup

or AirLifeTM Infant nCPAP

(1)

Generator is irrespective of patient demand or

. The outstanding

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 from NCPAP alone

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. Breath rate monitoring/alarm can be activated in this mode.

BiPhasic tr* – patient triggered pressure assists delivered based on clinician set Time-High and pressure criteria. Breath rate monitoring/alarm and Apnea backup breaths are automatically active in this mode.

Patented Infant Flow

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 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 Low breath rate/apnea alarm.

or AirLifeTM Infant nCPAP System Generator - The Infant

(2,3)

(1)

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.

675–101–101 Rev. K

2 Chapter 1 - Product Description

•

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.

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

(1) 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

(2) 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

(3) 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:Pediatric Pulmonolgy: 26 (5): 349-53; 1996

675–101–101 Rev. K

Infant Flow® SiPAP™ 3

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 (Comprehensive models only)

Controls

• Time High (T-High) – 0.1 – 3.0 seconds

• Rate (R)

1-120 (Non-U.S. Configuration Parameters)

1-54 (U.S. Configuration Parameters)

• Apnea Interval

• (T

• (TLBR) – 10-30 seconds; 5 second intervals (U.S. Configuration

• NCPAP / Pres Low flow meter – 0-15 L/min, accuracy ± 15% of selected

output

• Pres High flow meter – 0-5 L/min, accuracy ± 15% of selected output

• Manual Breath – X 1

• %O

Monitors

• CPAP

• PEEP

• MAP

• PIP

) – 10-30 seconds, 5 second intervals (Non-U.S. Configuration

apnea

Parameters)

– 21 -100%

• %O

• I:E ratio

• Spontaneous rate (Rsp)

• Battery charge level

675–101–101 Rev. K

4 Chapter 2 - Product Specifications

Alarms

• High airway pressure – 3 cmH2O above measured airway pressure

• Airway over-pressure limit alarm

• maximum 11 cmH

• maximum 15 cmH2O in patient triggered BiPhasic tr mode

• Low airway pressure – 2 cmH

1.5 cmH

O if otherwise would be zero

• High and Low delivered Oxygen concentration ±5% of setting. Minimum and maximum delivered FiO2 is 18 and 104% respectively.

• Low breath rate alarm

• Low battery charge level

• Flat battery

• 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 or 60 psi, clean, dry medical air and oxygen

O in NCPAP and time triggered BiPhasic mode

O below measured airway pressure or

• Range: 40.61 to 87 PSI; Maximum differential pressure 29 PSI

• Manometer: Range 0 to + 20 cmH

• Gas Connections: Standard DISS, NIST or Air Liquide 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

O, accuracy, ± 2% of span

675–101–101 Rev. K

Infant Flow® SiPAP™ 5

Atmospheric & Environmental

• Temperature Range

Operating: 5 – 40° C

Storage: - 20 - 50° C

• Relative Humidity -Operating: 0 – 95% non-condensing

• Storage: 0 – 95% non-condensing

Physical

• Dimensions (Driver only)-

• (W x H x D) 26 x38 x 23.5 cm

• (W x H x D) 10.25 x15 x 9.25 in

• Weight (Driver only)-

• 8.8 kg

• 19.5 lb

Accessories

• Silencer / Bacterial Filter - The additional resistance of the D1420/100

Silencer / Bacterial Filter and adaptor is less than 0.56 cmH and less than 0.40 cmH

O at 5 LPM.

O at 15 LPM,

675–101–101 Rev. K

6 Chapter 2 - Product Specifications

F&P 730

773386–102

Patient Circuit w/Generator (box of 20)

773387–101

Patient Circuit (box of 20)

773388–105

Patient Circuit RCI 16V (box of 20)

Prongs

Masks

777086–101

Nasal Mask - Small (box of 10)

006905

NCPAP Generator Kit

006915

Nasal Prongs - Medium

006920

Nasal Prongs - Large

Part No. Description

Infant Flow® Products

D1420/100 Silencer (box of 20)

11541–101 Patient Circuit Assembly (box of 20) 11541–102 Patient Circuit Assembly w/Generator (box of 20) 773386–101 Patient Circuit (box of 20)

F&P 850

12204–101 Patient Circuit (box of 20) 12204–102 Patient Circuit w/Generator (box of 20)

12233–102 Patient AirLife Circuit w/Generator (box of 20) 12233–101 Patient AirLife Circuit (box of 20)

RCI

773388–103 Patient Circuit w/Generator RCI 16V (box of 20) 773389–105 Patient Circuit RCI 21V (box of 20) 773389–104 Patient Circuit w/Generator RCI 21V (box of 20)

11513–101 Nasal Prongs - Small (box of 10) 11513–102 Nasal Prongs - Medium (box of 10) 11513–103 Nasal Prongs - Large (box of 10)

777086–102 Nasal Mask - Medium (box of 10) 777086–103 Nasal Mask - Large (box of 10) 777086–104

Nasal Mask Extra Large (box of 10)

AirLifeTM Products (U.S.A. only)

Prongs

006910 Nasal Prongs - Small

Masks

006925 Nasal Mask - Small 006930 Nasal Mask - Medium 006935 Nasal Mask - Large

675–101–101 Rev. K

Infant Flow® SiPAP™ 7

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 CareFusion (see page v).

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.

driver or other equipment.

the driver works.

Warnings

• Infant Flow® SiPAP™ is intended for use by a trained practitioner, under the

direct supervision of a qualified physician.

• When the Infant Flow

care professional should be in attendance at all times to react to an alarm or other indications of a problem.

• Always have an alternate means of ventilation available whenever the Infant

Flow

• Do not attach the Generator to the patient until User Verification and initial set

up into NCPAP mode is complete.

• Water in the air supply can cause malfunction of this equipment.

• The operator should not touch the electrical connectors of the Infant Flow®

SIPAP™ or its accessories, and the patient simultaneously.

• An audible alarm indicates an anomalous condition and should never go

unheeded.

SiPAP™ is in use.

SiPAP™ is connected to a patient, a trained health

675–101–101 Rev. K

8 Chapter 3 - Summary of Warnings and Cautions

• Anti-static 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™, it must be removed from use and referred to qualified service personnel for servicing. Using inoperative equipment may result in patient injury.

• Prior to patient application, ensure that all User Verification testing and calibration procedures are successfully completed. User Verification testing and calibration procedures must be done off patient.

• The

indicates a connection between the Transducer Assembly and the driver. It does not indicate attachment or correct positioning of the Abdominal Respiratory Sensor.

• 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 must be adjusted to zero when not required for the

patient.

• 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 treatment in general can cause nasal irritation, septal distortion, skin irritation and pressure necrosis. Adherence to the recommended usage instructions for the Infant Flow

SiPAP™ and AirLifeTM Infant nCPAP System

accessories may reduce the incidence of these complications.

• It is strongly recommended that regular monitoring for gastric distention be carried out for patients receiving non-invasive ventilatory support. Refer to your facility’s policy and procedure for further guidance.

• This device exhausts O

during normal operation. Oxygen vigorously

accelerates combustion. To avoid fire hazard, do not place flammable materials or sources of heat close to the exhaust.

• The Abdominal Respiratory Sensor is used only to enable features associated with certain modes from the Infant Flow

SiPAP™. 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 SaO

• If the Infant Flow

SiPAP™ driver is shelf mounted, ensure that the driver is

monitoring.

stable and that all circuit tubing, hoses and cables are restrained to avoid hazard of toppling.

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

• Do not block or restrict the exhaust port located on the instrument back panel. Equipment malfunction may result.

675–101–101 Rev. K

Infant Flow® SiPAP™ 9

• Do not use the equipment without the expiratory tubing connected to the

generator.

• Only use 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.

• 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 %O

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, “walkie-talkies”, or cellular phones.

• Due to possible explosion hazard, the Infant Flow

SiPAP™ should not be

used in the presence of flammable anesthetics.

• Electric shock hazard – Do not remove any of the Infant Flow

SiPAP™ covers or panels. Refer all servicing to an authorized CareFusion service technician or factory trained technician (see Service Manual P/N 675-120).

• 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 ventilator, and make sure the power cord is in good condition.

• The Infant Flow

SiPAP™ is designed to ensure that the user and patient are not exposed to excessive leakage current per 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 internal oxygen monitor is disabled, the Infant Flow

SiPAPTM unit is connected to a patient, and the

SiPAPTM unit must be

used with an external oxygen monitor.

675–101–101 Rev. K

10 Chapter 3 - Summary of Warnings and Cautions

Cautions

• 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 (i.e. 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 CSA/IEC601/ETL.

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

• The Infant Flow CareFusion accessories. Only accessories approved for use by CareFusion should be used. If in doubt, please contact your local sales representative.

SiPAP™ has been designed and tested using only

Notes

• 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 driver or pour cleaning liquids over or into the driver.

• Following each alarm verification test, ensure that control settings and alarm

limits are reset as instructed before proceeding to the next test.

• CareFusion cannot ensure product performance as stated in this manual with the use of Non-CareFusion accessories.

675–101–101 Rev. K

Infant Flow® SiPAP™ 11

Chapter 4 - Unpacking & Setup

Assembly and physical setup

Optional

Accessory

Figure 1 – Stand unpacking and assembly

675–101–101 Rev. K

12 Chapter 4 - Unpacking & Setup

Infant Flow

SiPAP Driver

Optional

Accessory

Figure 2 – Stand and Driver assembly

675–101–101 Rev. K

Infant Flow® SiPAP™ 13

Attaching a patient circuit

Infant Flow

SiPAP Driver

Optional

Accessory

Figure 3 – Driver assembled with patient circuit and /humidifier

Note

We recommend between 96.8 °F (36 °C) and 98.6 °F (37 °C) but never higher than

98.6 °F (37 °C) for inspired gases.

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14 Chapter 4 - Unpacking & Setup

CAUTION

Back pressure from some auto-feed humidifier chambers may cause the water bags to fill with air. Ensure that the humidifier chambers are adequately filled according to the manufacturer’s instructions.

Note

When the Hudson RCI Humidification System is being used with Infant Flow® SiPAP

, it is recommended that the standard compliance column be used.

Attaching the Abdominal Respiratory Sensor

Figure 4 – Attaching the Abdominal Respiratory Sensor

1. Connect the Transducer Assembly to the front panel of the driver (Fig. 3)

2. Connect Abdominal Respiratory Sensor to the Transducer interface.

3. Apply gentle compression to sensor. Verify function with illumination of LED on transducer interface.

4. Apply sensor with suitable tape (Fig 4).

a. Pressure line perpendicular to tape

b. Sensor between umbilicus and xiphisternum

c. Placement on the side of the abdomen may be necessary

5. Verify correct placement

a. Observe spontaneous breathing

b. Transducer LED illuminates on expiration; Front panel Transducer LED

illuminates on inspiration

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Infant Flow® SiPAP™ 15

Flow / Pressure Relationship

The Infant Flow® SiPAP™ is subject to a direct relationship between the controlled enriched gas flow and airway pressure. A nomogram illustrating the relationship between constant airway pressure and flow settings is shown in Figure 5. For example, 8 L/min gas flow provides approximately 5 cmH

Note

Individual devices have a tolerance of up to ± 10% from that illustrated in the nomogram and in particular, at pressures below 2 cmH

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

Figure 5 – Flow Pressure Nomogram

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16 Chapter 4 - Unpacking & Setup

User Verification Test

WARNING

Do not attach Generator to the patient until User Verification and initial set up into NCPAP mode is complete.

CAUTION

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

Power-on Check

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

• Flash ROM

• Hardware Inputs/Outputs

• Audible and visual alarms indicators

• Test and calibration of pressure sensor

• Test of dump valve

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

• Power Supply not connected

• Battery voltage low

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

During the Power Up check:

• Screen image shown in negative

• Warning bar comes on for one second

• Transducer Assembly LED comes on for one second

• Audible alarm sounds for one second

• Dump valve is tested

• Pressure is set to zero

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Infant Flow® SiPAP™ 17

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

Two Point O2 Sensor Calibration

Enter the Calibration Screen from the Set Up Screen by pressing the calibration button on the lower right hand corner of the touch screen. Ensure there is a minimum 8 LPM set on the NCPAP/PRES Low Flow meter. In addition, ensure there is a minimum of 3 LPM set on the NCPAP/High Flow meter. Adjust the %O 21%. Allow the %O associated flashing button.

display to stabilize. Confirm the calibration by touching the

control to

Adjust the %O touching the associated flashing button. Return to the Start up Screen by pressing the Exit button.

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

Note

If O2 calibration fails, a red “X” is shown. Refer to the Service Manual.

If the internal oxygen cell is depleted or damaged, it may not be possible to calibrate the O button. This will disable oxygen monitoring and the audible oxygen alarms until the device is powered off. Whenever the device is operating with oxygen monitor and alarms disabled, a fault code E5x displays, and measured FiO

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

displays as dashes.

WARNING!

When the Infant Flow® SiPAPTM unit is connected to a patient, and the internal oxygen monitor is disabled, the Infant Flow® SiPAPTM unit must be used with an external oxygen monitor.

If calibration is attempted, and fails, or if the oxygen cell fails while the device is in normal use, a Fault Code E5X displays, as tabulated in appendix D, and a high priority alarm is indicated visually and audibly. To enable continued operation, the internal oxygen monitoring may be disabled by pressing and holding the alarm mute / reset button for 3 seconds. This disables the internal oxygen monitor and alarms and clears the alarm condition. The E5X code remains to indicate that the oxygen monitor is inoperative. An external oxygen monitor must be used.

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18 Chapter 4 - Unpacking & Setup

Leak Test

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

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

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

4. Adjust the NCPAP / Pres Low flow meter to 8 L/min. Verify that the measured pressure is 5 ± 1 cmH

5. Adjust %O2 control as prescribed for the current patient. Verify that the blender setting, and the measured oxygen value, are within 3%. Touch the associated flashing screen icon to confirm.

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

7. Connect the Transducer Interface to the front panel of the driver if breath monitoring is desired in treatment. Touch the associated flashing screen icon to confirm.

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

9. Monitored parameter for CPAP should be 4-5 cmH leaks or blockages, (including the humidification system).

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

O. Touch the associated flashing screen icon to confirm.

O. If not, check circuit for

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

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Infant Flow® SiPAP™ 19

Alarm Test Initial Settings

nCPAP System Patient Circuit

Pres High flow meter

For Step 9 Use the settings provided below

Alarms Test

WARNING

Prior to patient application, ensure that all User Verification testing and calibration procedures are successfully completed. User Verification testing and calibration procedures must be done off patient.

NOTE

Following each alarm verification test, ensure that control settings and alarm limits are reset as instructed before proceeding to the next test.

Air Supply Pressure

Supply Pressure

Patient Circuit

Generator

NCPAP / Pres Low flow meter

% O2

Mode

Rate

T-High

Tapnea (Non-U.S. Configuration) / T

(U.S. Configuration)

LBR

> 30 psig (2.1 bar)

Infant Flow® or AirLifeTM Infant

Infant Flow® or AirLifeTM Infant nCPAP System Generator

8 L/min (for delivery of 5 cmH2O)

30%

3 L/min

NCPAP

30 bpm

0.3 sec

20 sec

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20 Chapter 4 - Unpacking & Setup

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

1. Make appropriate connections for air and O to appropriate AC outlet. Attach patient circuit, generator and patient interface (mask or prong) as shown in Figure 3. Occlude the opening to the patient.

2. Power up the driver and allow Power On Check to complete.

3. Low airway pressure alarm: From NCPAP operating mode, with alarms set, remove occlusion from opening to patient. Verify that the low airway pressure alarm activates. Restore the patient interface occlusion and press the Alarm Mute / Silence button for 3 seconds to reset the alarms.

4. High airway pressure alarm: Adjust the NCPAP / Pres Low flow meter to 11 L/min. Verify that the high airway pressure alarm activates. Return the NCPAP / Pres Low flow meter to 8 L/min and press the Alarm Mute / Silence button for 3 seconds to reset the alarms.

5. High %O

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

alarm activates. Return the O2 control setting to 30%. Reset alarms by pressing the Alarm Mute / Reset button for 3 seconds.

6. Low % O

Alarm: Adjust the % O2 control to 25%. Verify that the Low %O

alarm activates. Return the O2 control setting to 30%. Reset alarms by pressing the Alarm Mute / Reset button for 3 seconds.

7. Loss AC Alarm: Disconnect the AC power cord from the wall outlet. Verify that the Loss AC alarm activates. Reconnect the AC power cord. Clear the alarm by pressing the Alarm Mute / Reset button.

8. High Circuit Pressure Alarm: Increase nCPAP pressure to 11.1 cmH increasing the NCPAP/PRES Low Flow meter. Verify that the High Circuit pressure alarm activates. Return NCPAP/PRES Low Flow meter to 8 LPM and press the Alarm Mute/Silence button for three seconds to reset the alarms.

9. Low Breath Rate (Apnea) Alarm: Select and confirm BiPhasic+Apnea/LBR (U.S. configuration). Using the abdominal sensor, manually tap the abdominal sensor to simulate a spontaneous breath rate. The default mandatory breath rate should be left alone. No alarms should be present. Change the mandatory rate control setting to 1 bpm and stop tapping the abdominal sensor. Verify that the Low Breath rate alarm activates after the default interval of 20 seconds. Resume simulating spontaneous breath rate, turn the rate control to the default setting and clear the alarm by pressing the Alarm Mute/Reset button for 3 seconds. Note: a transducer must be connected to perform the alarm check.

gas supply. Connect power cord

O by

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Infant Flow® SiPAP™ 21

Two Point O2 Sensor Calibration

Patient Circuit Leak test

Low O

Alarm

Infant Flow® SiPAP™ User Verification Test Checklist

Driver Serial Number:_____________________ Test Date:_________________

TEST PASS FAIL

Automated Tests

Power On Check

Manual Tests

Manual Alarms Checks

Low Airway Pressure Alarm

High Airway Pressure Alarm

High O

Loss AC Alarm

High Circuit Pressure Alarm

Low Breath Rate (Apnea) Alarm

Alarm

Signature of tester:_______________________________________________

Title___________________________________________________________

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22 Chapter 4 - Unpacking & Setup

Infant Flow®

SiPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 23

Chapter 5 - Operation

Front Panel Indicators and Controls

The front panel consists of a LCD touch screen display with key pad, separate flow meter controls for adjustment of NCPAP /Pres Low and Pres High and a %O blender control. Patient circuit connections are located along the bottom panel. LEDs along the top of the front panel indicate power on, connection to wall AC, active alarms and Transducer Interface connection to the driver. An ambient light sensor is located under the front panel to adjust the backlight of the screen display in high and low light environments

Figure 6 – Front Panel

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24 Chapter 5 - Operation

Rear Panel

Figure 7 – Rear Panel

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Infant Flow® SiPAP™ 25

Table 2 - Soft-key operation

Description Example

A button which is enabled.

A button which is inhibited due to non-availability of the designated feature or pending acknowledgement of an active alarm condition.

A selected mode or control pending confirmation is visually highlighted and intermittently flashes between yellow and white text.

While a button is pressed the edges are highlighted to provide a pressed appearance.

When there is an active alarm associated with a measured value the measured value concerned is displayed with RED FLASHING text. The associated limit value (if any) is displayed in RED.

When an alarm that is associated with a measured value is resolved, the device remains in a LOW priority alarm state, with the measured value displayed in YELLOW FLASHING text and the associated limit displayed in YELLOW, until the alarms are cleared by the operator.

When parameter adjustments cause a reduction in another parameter to maintain requirements for minimum breath interval, the reduced parameter is displayed in RED for 15 seconds

Changing a control

When a control such as Time-High is selected, increase and decrease buttons appear. The control and the displayed value for the selected parameter are highlighted. Use the decrease or increase keys to adjust the parameter. You may accept the action by pressing the control button again. If no action is taken, the new parameter will take effect after 15 seconds.

In normal treatment screens, parameter changes take immediate effect.

When you change the mode, such as NCPAP to BiPhasic, press the flashing mode button to accept the change.

If no screen interactions occur for a period of 120 seconds and there are not active alarms, then the screen goes to a ‘locked’ state to prevent inadvertent entries. To unlock the screen, press the screen lock button. In the case of a high priority alarm, the screen immediately unlocks to allow access to controls.

CAUTION!

When changing a control, use only your finger. Damage to the touch screen could result if a pen or similar item is used to make changes.

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26 Chapter 5 - Operation

Increase / Decrease buttons

Pressing the ‘increase’ or ‘decrease’ buttons causes a currently-selected control to be changed to the next valid greater or lesser value. Each press of the increase or decrease button is accompanied by an audible click. If the control limit is reached an audible beep sounds to alert the operator.

Displays of calculated values (such as I:E ratio) dependent on a control setting change will change with acceptance of the parameter change.

Incompatible Control Settings

When a change to one control requires a change to a separate control to avoid an incompatible control setting, the required change is made automatically by the driver software.

If the adjusted control setting is restored prior to 15 seconds elapsed time or prior to pressing any other control, then the required change action is reversed.

For example in BiPhasic mode with T-High = 2.0, as R is increased above 28 b/min the constraint on minimum T-Low can be met only through a reduction in T-High. If R is increased to 29, then T-High shall reduce automatically to 1.9s. If R is then

immediately reduced to 28, the previous setting for T-High shall be restored.

Parameter default value on change of mode

Some controls are active in more than one operating mode. In these instances, there is a separate default value for operating modes as illustrated with the following table. Settings that are changed by the operator in one specific mode will be maintained if the mode is changed to another mode within the same mode group. All defaults shall revert to factory default on power-cycling or software restart.

Setting a Manual Breath

The manual-breath function is available in CPAP, Biphasic, and Biphasic tr modes. For manual breath to be active when the manual button is selected, the pre-use pressure-high check has been completed and the pressure high-flow meter is set for preferred manual breath. One manual breath is delivered per button-press.

Note:

The Pressure High Flow Meter must have flow above zero in order to deliver manual breaths.

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Infant Flow® SiPAP™ 27

apnea

LBR

Table 3 – Parameter Default Value

Mode

Parameter

T-High Default for NCPAP apply Default for BiPhasic apply Default for

Rate Default for BiPhasic apply

Rb Default for

/ T

NCPAP NCPAP + rate

monitoring

This setting applies to all modes: system-wide default applies to all modes

BiPhasic BiPhasic + rate

monitoring

BiPhasic tr

User Interface Display

Screen Displays

1. Set Up Screen – The Set Up screen prompts the user to confirm settings for base line pressure level (NCPAP / Pres Low), %O High) controls and confirmation of connection of the Transducer Interface (XDCR) to the driver.

, upper level pressure (Pres

Figure 8 – Set Up Screen

Adjust the NCPAP / Pres Low flow meter counter clockwise to increase the control to the required flow rate and clockwise to decrease the flow. Touch the associated flashing icon to confirm. The icon changes to a check mark and the next button flashes.

Set the %O

as prescribed. Touch the associated flashing button to confirm. The

icon changes to a check mark and the next button flashes.

Adjust the Pres High flow meter as desired for delivery of BiPhasic, BiPhasic tr or manual breaths using counterclockwise turns to increase and clockwise turns to decrease the flow. Touch the associated flashing button to confirm. The icon changes to a check mark and the next button flashes.

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28 Chapter 5 - Operation

If breath rate monitoring is desired, attach the Transducer Interface and the abdominal sensor. Refer to Chapter 4 for instructions on application of the Abdominal Respiratory Sensor. Touch the flashing button to confirm.

If an alarm is activated as a result of any of the settings, the button displays a flashing “X”. Alarm conditions must be cleared and all settings must be confirmed with a green check mark before other screens can be entered.

2. Alarm set/confirm Screen

Figure 9 – Alarm set/confirm Screen

Touch the NCPAP button or the Alarm Mute / Reset button for 3 seconds to set the alarms and to move to the next screen. If either button is not touched within 2 minutes, the alarm limits will be set automatically. When the alarm limits have been set, the screen display changes to the Mode Select Screen with the driver operating in NCPAP mode.

Note:

Press High Flow meter must be checked through the Start-up screen and be set during operation. This enables manual breath or back-up apnea breath, where applicable, to be active.

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Infant Flow® SiPAP™ 29

Figure 10 – Mode Select Screen

3. Mode Select Screen - Here the operator can select the desired mode of

operation. Once selected, the operator has the ability to adjust the screen controls for the mode selected. Only the relevant controls available for the selected mode are visible.

To make a change to a control, touch the control. Both the control and its

associated numeric display highlight and the adjust buttons appear. Press up or down buttons to adjust the setting as desired. Confirm the change by pressing the control again.

4. Parameter Adjust Screen – During normal operation, active controls for the current operating mode can be adjusted by touching the control, using the increase or decrease arrows to make the adjustments and then pressing the control again to confirm the change.

Figure 11 – Parameter Adjust Screens

5. Main screen– The Main Screen provides the operator with displays of current

mode of operation, alarm status, battery charge status, monitored parameters and a pressure time graphic display. Active controls are available for adjustment in this screen.

675–101–101 Rev. K

30 Chapter 5 - Operation

Figure 12 – Main Screen

6. Monitored Parameter Screen – This screen is accessed by pressing the

change screen button. The monitored parameters screen displays measured values and control settings. Adjustments to controls active for the currently selected mode are possible from this screen. To return to the main screen press the screens button again.

Figure 13 – Monitored Parameters Screen

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Infant Flow® SiPAP™ 31

Step by Step Fixation for Infant Flow System Generators

Following this fixation technique closely helps to ensure:

• Enhanced stability of the Generator

• Minimal disturbance to the infant

WARNING

Do not attach Generator to the patient until User Verification and initial set up into NCPAP mode is complete.

Patient Interfaces from CareFusion accommodate a wide range of patients. Application of an incorrectly sized prong, mask or bonnet will affect stability of the generator. The clinician may consider alternating the use of prong and mask interfaces at set intervals for a single patient in order to change pressure points on the infant’s face and reduce the risk of skin breakdown.

1. Measure for prong/mask size using the nose guide. Connect the interface to the generator.

2. Measure for bonnet size from the middle of the forehead to the nape of the neck and then back to the middle forehead. DO NOT use a “head

circumference” measurement to determine bonnet size.

3. Loosely weave Generator straps through the buttonholes. Begin from the inside of the colour coded buttonhole. Place the Generator on top of the bonnet above the central Velcro strip.

4. Place the bonnet onto the infant’s head, checking that the ears are in a normal position. Ensure the bonnet is pulled well down over the ears and down to the nape of the neck.

Switch on the power to the driver and complete Set Up Screen steps to enter

NCPAP mode with the prescribed settings for the current patient.

5. Lift the Generator from the top of the bonnet and bring towards the nose. Gently insert the nasal prongs/mask into position while supporting the Generator. Secure the generator straps horizontally across the infant’s cheeks.

Do not over tighten.

6. Secure all three tubes from the Generator with the central Velcro strip. Split the inspiratory and pressure lines and secure with secondary Velcro strips. Tie the open end of the bonnet if desired.

7. Final check:

• Nose in neutral position; eyes visible; ears not folded

• Desired upper and lower pressure levels and FiO

• Infant settles quickly after fixation

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are delivered

32 Chapter 5 - Operation

Every hour

Repeat checks listed above in Final Check.

Every 3-4 hours

Loosen the generator straps and release the tubes from the central Velcro strip. The nasal area can be cleaned with warm sterile water. Do not apply creams or ointments.

Ensure that:

• Nasal prongs/mask is not occluded with mucus/water droplets

• Patient prongs/mask and bonnet continue to fit appropriately.

• Re-apply the generator as described above.

Directions for using the AirLife™ Infant nCPAP System

Please refer to P/N 36-5569 included in the AirLifeTM Infant nCPAP Fixation Device for the Directions for Use.

WARNING!

CareFusion consumables are specifically designed to be used with Infant Flow® Drivers and are the only consumables validated for use with Infant Flow® devices.

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Infant Flow® SiPAP™ 33

Chapter 6 - Operating Modes

NCPAP

The Nasal CPAP mode can be enabled to have breath rate monitoring displayed (NCPAP +Apnea Mode, or NCAP +LBR Mode), or the system can operate without having the breath rate monitoring displayed (NCPAP Mode). Breath rate monitoring requires the use of the Transducer Assembly (part number 677-002) and the Abdominal Respiratory Sensor (part number 467349).

Figure 14 – NCPAP

BiPhasic

Allows for time triggered pressure assists, with or without breath rate monitoring and adjustable low breath rate alarm, delivered based on clinician set Time High (T-High) criteria, rate and pressure settings.

Figure 15 – BiPhasic

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34 Chapter 6 - Operating Modes

BiPhasic tr*

Allows for patient triggered pressure assists with breath rate monitoring enabled, adjustable apnea time interval, apnea alarm and adjustable apnea back up rate. The upper level pressure is delivered based on operator set Time High (T-High) and pressure settings.

Figure 16 – BiPhasic tr

* This mode available in Comprehensive configurations only.

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Infant Flow® SiPAP™ 35

Chapter 7 - Alarms and Indicators

Audible and visual indications are given to alert the Operator to specified conditions that affect operation. The electronic alarm limits are automatically set after two minutes without the necessity of Operator inputs.

Alarms can be manually set at any time if required (i.e. after settings change or patient disconnect/ reconnect) by pressing the Alarm Mute / Reset button for 3 seconds.

Alarm Priority

On activation of a MEDIUM or HIGH priority alarm, a locked screen will automatically revert to the unlocked display. The alarm status indicator flashes intermittently, based on the current, highest alarm priority. Distinct audible alarms represent a HIGH, MEDIUM or LOW priority alarm.

Measured parameters and alarm limits associated with a high or medium priority alarm condition flash RED (HIGH priority) or YELLOW (MEDIUM priority) to denote alarm condition and priority.

Silencing audible alarms

Pressing the Alarm Mute / Reset button will silence active alarms for up to 30 seconds. If a new high priority alarm condition occurs during the alarm silence time period, the silence will be cancelled to alert the operator of the new alarm condition.

Resetting alarms

Press the Alarm Mute / Reset button for 3 seconds to clear resolved and LOW Priority alarms and to reset alarm limits (i.e. after a control setting change). Where the alarm cause remains, the appropriate alarm will immediately reoccur.

Audible alarm priority

High Priority – a series of 10 tones (2 groups of 3 tones followed by a pause and 2

more tones) every 10 seconds

Medium Priority – three audible tones every 15 seconds

Low Priority – two audible tones every 30 seconds

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36 Chapter 7 - Alarms and Indicators

Alarm Types

The following alarm systems are provided with the Infant Flow® SiPAP™. Electronic alarms are set after 2 minutes of operation without operator intervention although the operator can manually set or reset them if required. Refer to Appendix C for information on troubleshooting alarms.

Supply Gases Failure

If the differential pressure between the two inlet gases falls outside of the limit of 30 PSI (2.0 bar) or one gas fails completely, an alarm will sound and the gas at the higher pressure only will be delivered to the patient.

High Airway Pressure

A HIGH priority audible and visual high pressure alarm activates when pressure reaches 3 cmH

Airway Over-Pressure Limit Alarm

A HIGH priority audible and visual high pressure alarm activates at 11 cmH2O during NCAP and time triggered BiPhasic modes and 15 cmH activation of this alarm, the patient circuit pressure drops to near zero. Pressure is restored after 3 seconds, and reduces to near zero again should the condition causing the alarm remain.

O above the measured airway pressure.

O in BiPhasic tr mode. Upon

Low Airway Pressure

A HIGH priority audible and visual low pressure alarm activates if pressures fall to 2 cmH otherwise be less than zero.

O below the measured airway pressure or at 1.5 cmH2O, if this would

High and Low % O2

HIGH priority audible and visual alarms are provided at ± 5% of the measured FiO2 with an upper maximum limit of 104% and a lower minimum limit of 18%.

A low hazard warning occurs at 18% Oxygen or below.

Low Battery Charge

If the battery charge falls below 40% the battery charge indicator changes from green to red as a warning indicator. In this instance, plug the driver into an approved AC power source.

Low Battery Voltage

If the battery voltage falls to < 11.10 V for 5 seconds a MEDIUM priority audible and visual alarm is activated. In this instance, plug the driver into an approved AC power source.

675–101–101 Rev. K

Infant Flow® SiPAP™ 37

Flat Battery

If the battery charge is too low to reliably power the analogue and valve driver circuits, the unit enters a safe ‘flat battery’ screen, until it is either switched off, or plugged into a suitable external power source. The screen display will go completely blank when the battery charge is too low to power it. While sufficient power is available, audible and visual indication of the high-priority alarm is maintained.

Figure 17 - Flat Battery screen

Operation without Electrical Power (No AC or DC power)

The Infant Flow® SiPAP™ will continue to deliver NCPAP flow only as set from the NCPAP / Pres Low flow meter and the set %O DC power. In this mode, visual indications and audible alarm warnings are not given except for the supply gases failure alarm.

in the event of a total loss of AC and

Error code indication

When a unit error is active, and this does not cause complete device failure, then a non-mutable HIGH priority alarm is activated with the error code displayed in flashing RED text in the upper right hand of the display screen, alternating with any currently displayed mode information. Refer to Appendix D for a listing of error codes. Remove driver from service and refer to a qualified service technician.

675–101–101 Rev. K

38 Chapter 7 - Alarms and Indicators

Alarm Symbols and Indicators

The following displays are shown within the graphical display. As needed displays in this table are shown separately as Domestic US configuration displays (left-hand column) and non-US configuration displays (right-hand column).

Table 4 – Alarm Symbols and Indicators

Indicator Meaning

Battery status/charge level; Green indicates full charge; red indicates charge < 40%)

External power source not connected

Flat battery

Battery fault (battery unable to hold charge) or supply fault

Respiratory transducer interface has become detached during breath monitoring

Indication during pre-use checks that the NCPAP / Pres Low flow meter should be set as desired and pressure verified

Indication during pre-use checks that the Pres High flow meter should be set as desired and pressure verified

Indication during pre-use checks and/or calibration that % O2 should be set and verified.

675–101–101 Rev. K

Infant Flow® SiPAP™ 39

Indicator Meaning

Indication during pre-use checks that operator should attach the respiratory sensor (cross indicates that transducer assembly is not connected)

Indication during pre-use checks that the operator should attach the respiratory sensor (indicates that transducer assembly is connected)

Does not verify attachment of sensor to patient

Refer to manual

Power has failed; re-connect external power source

Display of % O2 measured value and associated alarms

Display of NCPAP airway pressure measured value and alarms (NCPAP modes only)

Display of mean airway pressure measured value and alarms (BiPhasic and BiPhasic tr* modes only)

I:E ratio

Spontaneous breathing rate

Set parameter T-High

Set parameter Rate (BiPhasic modes only; mandatory rate)

Set parameter RB (BiPhasic tr* mode only; backup rate)

Set parameter low breath rate or apnea alarm timeout

675–101–101 Rev. K

40 Chapter 7 - Alarms and Indicators

Indicator Meaning

Display of measured airway pressure graph. With breath monitoring active, spontaneous breaths are indicated in yellow, below delivered airway pressure graph.

Device fault (fault code will be indicated). Refer to manual. Contact qualified service technician.

Note

Provision of labeling in this manual for any function should not be taken as evidence that the function is available. For example parameter RB relates to BiPhasic tr* mode, not currently approved for use in the US.

675–101–101 Rev. K

Infant Flow® SiPAP™ 41

Chapter 8 - Maintenance & Cleaning

Cleaning

Examine the exterior of the case and the stand for damage and dirt. If necessary clean the unit and stand. If damage to either is apparent, always seek qualified Technical advice.

Clean the exterior surfaces of the driver, Transducer Assembly and stand with a mild soap or liquid disinfectant solution. Do not use cleaning agents that contain abrasives. Make sure that cleaning agents do not enter the driver through patient connections or other ports.

CAUTION

Do not immerse any part of the Infant Flow® SiPAP™ driver in water or sterilize it with gas or steam.

Maintenance

No special maintenance is required by the operator other than that listed below. There are no operator serviceable parts. The unit must only be maintained and serviced by an approved service supplier or trained biomedical engineer. Only parts approved by CareFusion may be used in this unit. Refer to the Service Manual or your Service Supplier for an approved service parts list

WARNING

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

Calibrate the oxygen analyzer regularly. Calibration of the oxygen analyzer must be done with the unit off patient.

Regularly check and empty the water trap accessed from the rear panel of the driver enclosure. Push the button on the bottom of the water trap to release the water into a suitable waste receptacle.

Disconnect the air and oxygen gas sources when the Infant Flow use.

SiPAP™ is not in

675–101–101 Rev. K

42 Chapter 8 - Maintenance & Cleaning

Storage and Battery Care

Store the unit in a clean dry location. Make sure that all connections and ports are suitably covered to prevent the ingress of dirt, moisture and foreign objects. If the unit is not being used for a long period of time, remove the battery (refer to the Service Manual or your Service Technician).

Dispose of scrap units in accordance with the local regulations. Refer to the Service Manual or your Service Supplier.

675–101–101 Rev. K

Infant Flow® SiPAP™ 43

IEC 60878

IEC 30878

IEC 60878

Chapter 9 – Explanation of Symbols

Equipment Symbols

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

Table 5 – Equipment Symbols

Symbol

Symbol #5031 IEC

Source / Compliance

Symbol #03-02 IEC 60878

Symbol #5016 IEC 60417

60417

Symbol #5019 IEC 60417

Symbol #01-20

Meaning

Indicates ATTENTION, consult ACCOMPANYING DOCUMENTS

This symbol indicates a FUSE.

This symbol indicates DIRECT CURRENT (DC)

This symbol indicates protective EARTH (ground).

Symbol #5021 IEC 60417

Symbol # 01-24 IEC 60878

Symbol # 5333 IEC 60417

Symbol #02-03 IEC 60878

Symbol #5032 IEC 60417

Symbol #01-14

Symbol #5007 IEC 60417 Symbol #01-01 IEC 60878

Symbol #5008 IEC 60417 Symbol #01-02

MDD Directive 93/42/EEC

This symbol indicates the EQUIPOTENTIAL connection used to connect various parts of the equipment or of a system to the same potential, not necessarily being the earth (ground) potential (e.g., for local bonding).

This symbol indicates TYPE B equipment, which indicates equipment that provides a particular degree of protection against electric shock, particularly with regards to allowable leakage current and reliability of the protective earth connection.

This symbol is located on the rating plate. It indicates the equipment is suitable for alternating current.

Indicates ON (Power)

Indicates OFF (Power)

CE Mark

CareFusion Symbol

675–101–101 Rev. K

This symbol indicates an INTERNAL BATTERY FUSE

44 Chapter 9 – Explanation of Symbols

ISO 15223:2000

Symbol

2.5A/T 250 V 101010

XDCR

Source / Compliance

ISO 7000:2004 (2616)

ISO 15223:2000 (3.11)

EN 980:2003 (5.7.3)

N/A

CareFusion Symbol

IEC 60878:1988 (01-41)

ISO 7000:2004 (2301)

IEC 60878:1988 (02-03)

Meaning

Electrical AC inlet

Operating temperature range of unit

Fuse holder and fuse rating

Transducer Assembly

Warning Bell

Type BF patient applied part

ETL Mark and Registration Number

Intertek Group

ISO 15223: 2000 (3.13)

EN 980:2003 (4.4)

IEC 60878 (03-02)

ISO 15223:2000 (3.1.4)

EN 980:2003 (4.4)

(3.12)

EN 980:2003 (4.3)

ISO 15223:2000 (3.2)

EN 980:2003 (4.2)

Year of Manufacture

Read Accompanying Documents

Unique Batch Number Identifier

Use Before Expiry Date shown Year-Month

Single Use Only - Do NOT Re-use

675–101–101 Rev. K

Infant Flow® SiPAP™ 45

Symbol

Source / Compliance

ISO 15223:2000 (3.8)

Meaning

Keep Dry

Keep Away from Heat

Symbols used on buttons

The following symbols are used to label user input areas within the graphical display. As needed displays in this table are shown separately as Domestic US configuration displays (left-hand column) and non-US configuration displays (right-hand column).

Table 6 – Button Symbols

Symbol Description

High Priority Alarm Active, red flashing

Medium Priority Alarm Active, yellow flashing

Low Priority Alarm Active, yellow, does not flash.

No alarms are present, green, does not flash

Active alarm silenced

Adjust BiPhasic rate

Adjust BiPhasic tr* backup rate

Adjust apnea alarm timeout

Adjust low breath rate alarm timeout

Adjust BiPhasic, BiPhasic tr* on time, and NCPAP manual breath function

675–101–101 Rev. K

46 Chapter 9 – Explanation of Symbols

Symbol Description

Decrease / Increase currently selected parameter

Go to mode select screen.

Nasal CPAP mode

Nasal CPAP mode with breath rate monitoring

BiPhasic mode

BiPhasic mode with breath rate monitoring

BiPhasic tr* mode with breath rate monitoring

Manual Breath. Single BiPhasic cycle at current

. One BiPhasic

settings for T-High, Pres High and % O cycle is delivered regardless of button press duration

Toggle between Main Screen and Monitored Parameter Screen

Go to user calibration screen

Confirm

Wait

Completed

Action has failed

Press to un-lock keypad

Warning message. To clear, press any of the three icons.

Oxygen monitor and alarms disable

675–101–101 Rev. K

Infant Flow® SiPAP™ 47

Note

Provision of labeling in this manual for any function should not be taken as evidence that the function is available. For example parameter R not currently approved for use in the US.

relates to BiPhasic tr* mode,

675–101–101 Rev. K

48 Chapter 9 – Explanation of Symbols

Infant Flow®

SiPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 49

High

15%

Appendix A - Product Configurations

Non-US Configuration Parameters

Table 7 – Non-US Configuration Parameters

Parameter Min Max Accuracy Units Default

Set Oxygen concentration, %O2 21 100

NCPAP / Pres Low flow rate 0 15

Pres High flow rate 0 5

BiPhasic / BiPhasic tr* on time, T-

0.1 3.0

±15%

± 15%

± 0.005

% N/A

L/min N/A

seconds .3 sec

BiPhasic rate, R (mandatory rate) 1 120

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

Apnea timeout, Tapnea 10 30

1 120

± 0.5

bpm 30 bpm

bpm 10 bpm

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

US Configuration Parameters

Table 8 – US Configuration Parameters

Parameter Min Max Accuracy Units Default

Set Oxygen concentration, %O2 21 100

NCPAP / Pres Low flow rate 0 15

Pres High flow rate 0 5

BiPhasic on time, T-High 0.1 3.0 *

BiPhasic rate, R (Mandatory rate) 1 54

Low Breath Rate timeout, T

10 30

LBR

±3

± 15%

± 0.005

± 0.5

% N/A

L/min N/A

seconds 1.0 sec

bpm 10 bpm

Seconds 20 sec

Note

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

675–101–101 Rev. K

50 Appendix A - Product Configurations

Infant Flow®

SiPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 51

Appendix B - Pneumatic Diagram

675–101–101 Rev. K

52 Appendix B - Pneumatic Diagram

Infant Flow®

SiPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 53

Appendix C - Alarm Troubleshooting

Table 9 – Alarm Troubleshooting

Alarm

%O2 < 18% High

%O2 > 104% High

High %O2

(> 5% above setting for 15

seconds).

Low %O2

(> 5 % below setting for 15

seconds).

Over pressure

(> 11 cmH in NCPAP and BiPhasic modes)

Over pressure

(> 15 cmH in BiPhasic tr* mode)

Low battery charge

(< 40%).

Priority Possible Cause

• O

required.

• O

High

required.

• Blender setting changed.

• Supply gas failure

• Water trap overflow

High

• Blender setting changed.

• Supply gas failure

• Water trap overflow

High

• Flow rate set too high.

• Occlusion of exhalation limb

• Blocked silencer/bacteria filter

High

• Flow rate set too high.

• Occlusion of exhalation limb

• Blocked silencer/bacteria filter

Warning indication.

• Battery status indicator changes from green to red.

calibration

Actions

• Restore FiO2 level to above the minimum limit

• Press Alarm Reset for 3 seconds.

• Recalibrate O

as soon as

practicable.

• Restore FiO2 level to below the maximum limit

• Press Alarm Reset for 3 seconds.

• Recalibrate O

as soon as

practicable.

• Press Alarm Mute to silence the alarm

• Correct delivered oxygen concentration

• Press Alarm Reset for 3 seconds to set new limits

• Press Alarm Mute to silence the alarm

• Correct delivered oxygen concentration

• Press Alarm Reset for 3 seconds to set new limits

• Check exhaust tube / filter

• Reduce flow rate to achieve

pressure below high pressure limit

• Press Alarm reset for 3 seconds to set new limits

• Check exhaust tube / filter

• Reduce flow rate to achieve

pressure below high pressure limit

• Press Alarm reset for 3 seconds to set new limits

• Connect external power

675–101–101 Rev. K

54 Appendix C - Alarm Troubleshooting

Alarm

Priority Possible Cause

Battery fault High (Cannot be

reset)

Low battery

Medium

voltage < 11.10 V for

5 seconds).

AC power

High

disconnected

High

High NCPAP / Pres Low

(CPAP > 3

cmH

above set

for 15 seconds).

Low NCPAP

High / Pres Low

( CPAP < 2

cmH

below set

for 15 seconds)

< 1.5 cmH

at any time).

High

High BiPhasic or BiPhasic tr* pressure

(MAP > 3

cmH

above

set for 15 seconds).

BiPhasic or BiPhasic tr*)

High (Cannot be

silenced) mode fails to operate as set.

• Battery disconnected

• Battery failing to hold charge

• Battery disconnected

• Battery failing to hold charge

• AC power disconnected

• NCPAP / Pres Low setting change

• Circuit disconnect / reconnect

• NCPAP / Pres Low setting change

• Circuit disconnect / reconnect

• Circuit leak

• Pres High setting

change

• Circuit disconnect / reconnect

• See description of error code displayed

Actions

• Push Alarm Mute button for 3 seconds to silence alarm

• Refer to Service Engineer.

• Push Alarm Mute button for 3

seconds to silence alarm

• Connect AC power

• Push Alarm Mute button for 3

seconds to silence alarm

• Reconnect the AC power.

• Push Alarm Mute button for 3

seconds to silence and reset alarm limits

• Reset alarm limits after setting change and patient circuit disconnect / reconnect

• Push Alarm Mute button for 3 seconds to silence and reset alarm limits

• Reset alarm limits after setting change and patient circuit disconnect / reconnect

• Check for leaks in patient circuit

• Push Alarm Mute button for 3

seconds to silence and reset alarm limits

• Reset alarm limits after setting change and patient circuit disconnect / reconnect

• Revert to nCPAP mode

• Refer to Service Technician

675–101–101 Rev. K

Infant Flow® SiPAP™ 55

rate

fails completely

power

Alarm

Low breath rate

Flow meter fault.

Gas Supply failure

Oxygen cell calibration error.

Electrical fault.

Water trap blocked

Software fault

Software not running with

unit connected to

Priority Possible Cause

High

• Plus: audible / visual alarms only

• Comprehensive : audible / visual alarms and backup

N/A

High

(Cannot be reset)

High

(Cannot be reset)

• Rr = 0 for > low breath (apnea) interval timeout

• No flow indications

• Flow can’t be

adjusted.

• Differential pressure between the two inlet gases falls outside of the limit of 30 PSI (2.0 bar) or one gas

• Oxygen cell incorrectly calibrated, damaged or depleted

• AC power LED does not match screen icon.

• Full or leaking

• Filter blocked

• Loss of wall

pressure

• Imbalance in gas supply

• See description of error code displayed

Actions

• Push Alarm Mute button once to silence alarm

• Restore patient breathing.

• Check placement / connection of

abdominal Respiratory Sensor

• Refer to Service Technician.

• Check gas inlet supplies

• Check inlet water trap

• Refer blender to service technician

• Calibrate or replace oxygen cell.

• Refer to Service Manual.

• Refer to Service Technician

*BiPhasic tr mode not currently available in the United States

675–101–101 Rev. K

56 Appendix C - Alarm Troubleshooting

Infant Flow®

S iPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 57

and BiPhasic tr*)

worst error code

Appendix D - Fault Management

The general philosophy when handling a software detectable fault condition is to still allow a basic level of treatment to be applied to the patient - with over pressure protection, oxygen alarms and apnea monitoring (where possible), but inhibiting the higher level features of the unit (such as BiPhasic modes).

Fault classification

Each fault condition is classified according to the severity ratings (where  means not available under software control,

(

) means may or may not be available depending on other severity rating 3 and 4

conditions, which may occur individually or simultaneously):

Table 10 – Fault Classification

 means available under software control, and

Measurements

Control Modes and Features

Severity

(major)

Classification

Un-usable

Restricted

Untriggerable

Impact On Unit Functionality

Unit is inoperable under software control, but can still be used in an unpowered pneumatic mode

Unit functionality is restricted to NCPAP modes only

Patient trigger functions not available (NCPAP and BiPhasic with breath monitoruing on

Reporting Mechanism

A list of error codes are presented to the user via the "Fault lockout" display

Where applicable, error codes listed on mode selection screen. Status bar mode alternates with worst error code

Where applicable, error codes listed on mode selection screen. Status bar mode alternates with

O2 %

     

     

     

CmH

NCPAP

+apnea

Biphasic

biphasic

Unit will not

(minor)

No backup

operate on battery when the external power is removed

Battery status appears as if flat battery

  

() () ()

675–101–101 Rev. K

58 Appendix D - Fault Management

worst error code

error code.

Clas-

Software

Corrective

(minor)

Severity

Classification

Spurious

No oxygen monitor

Impact On Unit Functionality

Spurious software exception trapped

Non-fatal error trapped

Oxygen monitor and alarm functions are not available.

Reporting Mechanism

Software restarts, and status bar extended mode alternates with

High-priority alarm; status bar extended mode alternates with worst error code

High priority alarm may be cleared by operator reset; status bar extended mode alternates with

Measurements

O2 %

  

     

    

Control Modes and Features

CmH

NCPAP

() () ()

+apnea

Biphasic

biphasic

Fault recovery / action

If a detectable fault condition occurs (either before treatment begins or while being applied) the software will respond in the following way:

Table 11 – Fault Recovery

E## Fault condition Consequence

Program memory

checksum error

Battery too flat (<6.5V) to operate LCD,

analogue and valve driver circuits (no external power) Battery too flat (<10.25V) to operate analogue and valve driver

circuits but

sufficient for LCD driver (no external power)

Software corrupt execution inhibited

No user interface display

Sensor readings invalid

sification

Unusable

Response

Hardware held in permanent reset condition with alarm bar lit (status LED on)

Hardware held in reset condition with alarm bar lit (status LED off) until external power applied

User lockout: "Plug in external power" prompt

Action Required

Service: Reload software

User: Plug in external power

675–101–101 Rev. K

Infant Flow® SiPAP™ 59

calibration data

and Flow)

flat)

"E##" alarm

circuits

rail)

prompt

sense)

E## Fault condition Consequence

Unable to

Non-volatile

E10

memory fault

Calibration data

E11

lost

retrieve/set unit configuration and

Sensor readings invalid

Configuration DIP settings and/or PT PRESENT

E12

different to nonvolatile

Possible incomplete unit

set-up performed configuration record Charged battery voltage too low

E20

(<11V) when

Battery capacity

low under test load External supply voltage too low

E21

(<14V) to charge battery (battery

Battery will not

charge

Clas-

sification

Unusable

No backup

Software Response

User lockout: Error "E##" prompt

Battery fault icon flashes and "E##" alarm

Battery low alarm continues even through external power applied -

Corrective Action Required

Service: Fix or replace PCB

Service: Low level calibration

, Pressure

Service: Perform set-up procedure

Service: Fix Battery or charger

User: Plug in correct external supply Service: Fix PSU

Analogue supply

E22

rails out of limits

Valve driver

E23

supply rails out of limits Hardware 'safe-

E24

start' watchdog disabled Pressure sensor

E30

fault (ADC hits

Zero valve not

E31

connected (via sense) Zero valve

E32

activation fault (via sense) Unable to auto-

E33

zero pressure sensor Dump valve not

E41

connected (via

Dump valve

E42

activation fault (via sense)

Unreliable sensor

readings

Valve operations

unreliable

Unusable

Valves disabled Unusable

Pressure sensor

readings invalid

Unusable

Pressure sensor

readings

Unusable unreliable Pressure sensor readings

Unusable unreliable

No over pressure protection

Restricted

User lockout: Error "E##" prompt User lockout: Error "E##" prompt User lockout: Error "E##" prompt User lockout: Error "E##"

User lockout: Error "E##" prompt User lockout: Error "E##" prompt User lockout: Error "E##" prompt

Restricted mode: Error "E##" alarm

Service: Fix circuits

Service: Fix valve supply rail

Service: Fix reset/safe-start circuits

Service: Fix sensor/circuits

Service: Fix valve/circuits

Service: Fix valve/sensor/circ uits

Service: Fix valve/circuits

675–101–101 Rev. K

60 Appendix D - Fault Management

or high gain)

blender.

timeout)

blender.

report Apnea

E## Fault condition Consequence

Oxygen sensor

E50

fault (ADC hits rail) Oxygen sensor can not be

E51

recalibrated by user (bad offset

Oxygen sensor calibrates but the

E52

fuel cell is wornout (low gain)

Oxygen sensor readings invalid

Possible fuel cell, electronic, blender or gas supply fault

Oxygen sensor readings unreliable

Oxygen sensor

Oxygen sensor readings unreliable

E53

too noisy to calibrate (calibration

Oxygen calibration may be invalid (O

E54

reading below 17% or above

Oxygen sensor readings unreliable

104% detected)

Oxygen sensor

E55

disabled by the operator

BiPhasic valve

E61

not connected (via sense) BiPhasic valve

E62

activation fault (via sense)

Oxygen sensor readings unreliable

BiPhasic modes unusable

Apnea and/or

PT transducer

disconnected

patient trigger unusable/interrup ted

PT module fault

E70

(PTRDY or CAN bus failure) No breath signal from PT module

E71

although CAN data does not

Apnea and patient trigger unusable

Patient may be in apnea but PT module dysfunctional?

Clas-

sification

No oxygen

monitor

No oxygen

monitor

No oxygen

monitor

No oxygen

monitor

No oxygen

monitor

No oxygen

monitor

Restricted

Un-

triggerable

Un-

triggerable

Untriggera

ble

Software Response

High priority alarm; Error "E##" prompt

Error “E##” prompt

Restricted mode: Error "E##" alarm

NCPAP and BiPhasic modes with breath monitoring on, inhibited (or low breath rate alarm given if treatment started) Reduced functionality "E##" alarm

Reduced functionality "E##" alarm

Corrective Action Required

Service: Fix sensor/circuits.

User: Check gas supplies. Service: Fix sensor/circuits/

User: Check gas supplies. Service: Replace sensor. User: Check gas supplies. Service: Fix sensor/circuits/

User: recalibrate the oxygen cell.

User: re-power the device to reenable oxygen monitoring

Service: Fix valve/circuits

User: Reconnect PT transducer

Service: Fix PT/circuits

No trigger signal

E72

from PT module

BiPhasic tr* mode inoperable.

Untriggera

ble

Reduced functionality "E##" alarm

Service: Fix PT/circuits

675–101–101 Rev. K

Infant Flow® SiPAP™ 61

E## Fault condition Consequence

Spurious software interrupt, XTAL

(E9

fails, stack

0) overflow/underflo

w, CPU Class B exception

Abnormal hardware,

E90

software or watchdog reset

Internal software

E91

error detected

Unknown error

E99

detected

Software interrupted and restarts (possibly during treatment)

Software restarts possibly during treatment

Software unreliable

[1] Error codes in parentheses (brackets) are generated as an indirect consequence of the problem.

* Biphasic tr mode not currently available in the United States

Clas-

sification

Spurious

Unusable

Software Response

Hardware reinitialized (disabled) with alarm bar lit and beeper sounding to identify root cause

Software restarts

- "E##" alarm

User lockout: Error "E##" prompt User lockout: Error "E##" prompt

Corrective Action Required

Software: Fix persistent exceptions

Software: Fix persistent exceptions Service: Fix abnormal reset

Software: Fix software error

Fault code display screen

The fault lockout screen shall incorporate item ref. (as appropriate to build) and shall display a list of all active fault codes. Faults not resulting in user lockout shall result in indication on the status bar.

675–101–101 Rev. K

62 Appendix D - Fault Management

Infant Flow®

SiPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 63

Term

Meaning

Apnea

Temporary inability to breathe.

mandatory)

CPAP

Continuous Positive Airway Pressure

mask

NCPAP+Apnea

NCPAP with Low Breath Rate monitoring (non-US labeling)

Rate

Mandatory rate (per minute); active in BiPhasic mode

RSP

Patient’s spontaneous respiratory rate (per minute)

s / sec

Seconds



US labeling

Labeling using English text in place of symbols and/or icons

PEEP

Positive End-Expiratory Pressure

PIP

Peak Inspiratory Pressure

Glossary

LBR Low Breath Rate

Bpm

Breaths per minute (applies to each of spontaneous, triggered and

Generator

BiPhasic

BiPhasic+LBR BiPhasic with Low Breath Rate monitoring (US labeling)

BiPhasic tr*

BiPhasic tr+Apnea* NCPAP Nasally applied CPAP NCPAP+LBR NCPAP with Low Breath Rate monitoring (US labeling)

/ T

apnea

T-High Length of time (in seconds) for a sigh or manual breath (Time High).

Non-US labeling

LBR

Patient attachment for delivering CPAP, used with nasal prongs or

Time triggered, time cycled pressure assists at two separate pressures levels.

Patient triggered, time cycled pressure assists at two separate pressure levels. *This mode currently not available in the United States. BiPhasic tr* with Low Breath Rate monitoring (non-US labeling). *This mode currently not available in the United States.

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

Apnea Interval (non-US labeling) or Low Breath Rate (LBR) monitor alarm time (US-labeling); both in seconds This mnemonic may also be associated with an alarm icon

Labeling using non-linguistic symbols in place of English text wherever possible

Pres Low

Pres High

675–101–101 Rev. K

Adjustable lower baseline pressure level control in BiPhasic and BiPhasic tr modes Adjustable upper pressure level control in BiPhasic and BiPhasic tr modes

Infant Flow®

SiPAP™

675–101–101 Rev. K

Infant Flow® SiPAP™ 65

Index

fixation, 31

Absominal Respiratory Sensor, 14 Accessories, 2 airway pressure, 15 alarm priority, 35 Alarm set/confirm Screen, 28 Alarm Symbols, 38 alarms, 4 Alarms, 35 Alarms Test, 19 assembly, 11

Battery Backup, 1 Battery Care, 42 BiPhasic, 1, 33 BiPhasic tr, 1, 34 button symbols, 45

Flat Battery alarm, 37 front panel, 23 Fully integrated alarm package, 1

gas flow, 15

High Airway Pressure alarm, 36 High and Low % O High Patient Circuit Pressure alarm, 36

alarm, 36

incompatible control settings, 26 increase buttons, 26 Indicators and Controls, 23 intended use, ix

calibration

O2 sensor, 17

cautions, 7 Circuit Occlusion Alarm, 20 classification, x Cleaning, 41 configuration

Comprehensive, 1 Plus, 1

Configurations, 49 control buttons, 25 controls, 3

decrease buttons, 26

electrical supply, 4 electromagnetic components, ix EMC, ix environmental requirements, 5 Error code indication alarm, 37

fault lockout screen, 61 faults, 57 features, 1

Leak Test, 18 Low Airway Pressure alarm, 36 Low Battery Charge alarm, 36 Low Battery Voltage alarm, 36

Main Screen, 29 Maintenance, 41 manual breath

setting, 26

Mode Confirm Screen, 29 modes, 3 Monitored Parameter Screen, 30 monitors, 3 MRI, ix

NCPAP, 1, 33 notes, 7

O2 sensor

calibration, 17

Operating Modes, 33 Operation without Electrical Power alarm, 37

675–101–101 Rev. K

66 Index

Parameter Adjust Screen, 29 parameter default values, 26 Patented Infant Flow patient circuit, 13 physical specifications, 5 Pneumatic Diagram, 51 pneumatic supply, 4 power-on check, 16

Generator, 1

radio frequency energy, ix Rear Panel, 24 reset alarm limits, 35

safety information, 7 Screen Displays, 27 Screen Lock, 2 Set Up screen, 27

silence active alarms, 35 Silencer / Bacterial Filter, 5 Soft-key operation, 25 specifications, 3 Storage, 42 Supply Gases Failure alarm, 36 symbols, 43

Troubleshooting, 53

User Interface, 27

User Verification Test, 16 User Verification Test Checklist, 21

warnings, 7 warranty, vi

675–101–101 Rev. K

CareFusion Infant Flow SiPAP User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Infant Flow® SiPAP™

Operator’s manual

R evision History

Warranty

Contents

List of Figures

List of Tables

Notices

Chapter 1 - Product Description

Infant Flow® SiPAP™ Features

Chapter 2 - Product Specifications

Modes

Controls

Monitors

Alarms

Pneumatic Supply

Electrical Supply

Atmospheric & Environmental

Physical

Accessories

Chapter 3 - Summary of Warnings and Cautions

Terms

Warnings

Cautions

Notes

Chapter 4 - Unpacking & Setup

Assembly and physical setup

Attaching a patient circuit

Attaching the Abdominal Respiratory Sensor

Flow / Pressure Relationship

User Verification Test

Power-on Check

Two Point O2 Sensor Calibration

Leak Test

Alarms Test

Infant Flow® SiPAP™ User Verification Test Checklist

Chapter 5 - Operation

Front Panel Indicators and Controls

Rear Panel

Changing a control

Increase / Decrease buttons

Incompatible Control Settings

Parameter default value on change of mode

Setting a Manual Breath

User Interface Display

Screen Displays

Step by Step Fixation for Infant Flow System Generators

Every hour

Repeat checks listed above in Final Check.

Every 3-4 hours

Directions for using the AirLife™ Infant nCPAP System

Chapter 6 - Operating Modes

NCPAP

BiPhasic

BiPhasic tr*

Chapter 7 - Alarms and Indicators

Alarm Priority

Silencing audible alarms

Resetting alarms

Alarm Types

Supply Gases Failure

High Airway Pressure

Airway Over-Pressure Limit Alarm

Low Airway Pressure

High and Low % O2

Low Battery Charge

Low Battery Voltage

Flat Battery

Operation without Electrical Power (No AC or DC power)

Error code indication

Alarm Symbols and Indicators

Chapter 8 - Maintenance & Cleaning

Cleaning

Maintenance

Chapter 9 – Explanation of Symbols

Equipment Symbols