Infant Flow SiPAP Operators Manual Rev P June 2013

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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. © 2009–2013 CareFusion Corporation or one of its subsidiaries. All rights reserved. CareFusion, the CareFusion logo, and Infant Flow are trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners. CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 U.S.A.

CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg Germany

800.231.2466 toll-free 714.283.2228 tel 714.283.8493 fax

+49 931 4972.0 tel +49 931 4972.423 fax

carefusion.com

Literature number: 675–101–101 Revision P

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Revision 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

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.

March 2005

F

Updated the contact information. Updated the Declaration of Conformity Notice.

May 2006

G

Updated the company name. 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” to the first paragraph under “Two Point O2 Sensor Calibration. Changed step 8 regarding the nCPAP pressure. Changed the second and third paragraphs under Changing a Control. 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 is not in use.” 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”. TM

Added reference to AirLife Infant nCPAP System Generator. Removed “inspiratory time” or “inspiration time”. Replaced “Inspiratory Time (Time High)” with “Time High

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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 AirLife Products.

TM

Added reference to Cardinal Health contact information on page v. Added reference to AirLife™ 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.” 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 2 manual breath delivery; Added hyphen in “T-High”.

nd

Flow Meter being used for

Clarified the “Mode Select Screen” Added “Directions for using the AirLife™ 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.

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Infant Flow SiPAP Date

Revision

Changes

March 2010

K

Rebranded the manual to the CareFusion style. Updated the part number table.

January 2011

L

Changed the logo and company references to VIASYS.

January 2011

M

Changed the logo and company references to CareFusion.

March 2013

N

Corrected the pneumatic supply range specification. Corrected the atmospheric and environmental storage specification.

June 2013

P

Removed TM from SiPAP. Changed ® to TM for the name Infant Flow. Updated the address information to include symbols. In the “Flow/Pressure Relationship” section, added the Flow pressure nomogram for the Infant Flow LP generator. In the Leak Test procedure, step 4, added “(for the Infant Flow LP generator, adjust the flow meter to 9 L/M).” In the “Alarms Test” section, in the Alarm Test Initial Settings table, added “Infant Flow LP: 9L/min (for delivery of 5 cmH2O)” to the NCPAP / Pres Low flow meter specification. Updated figures to remove references to VIASYS.

Corrected the Intended Use Notice. Added the “SiPAP Gas Monitor” section. Added the “Electromagnetic Environment Specifications” section. Fixed paragraph misalignment where needed.

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Infant Flow SiPAP

Warranty Infant Flow™ SiPAP is warranted to be free from defects in material and workmanship and to meet the published specifications for One (1) year from date of shipment. The liability of CareFusion Corporation (referred to as the Company) under this warranty is limited to replacing, repairing or issuing credit, at the discretion of the Company, for parts that become defective or fail to meet published specifications during the warranty period; the Company will not be liable under this warranty unless (A) the Company is promptly notified in writing by Buyer upon discovery of defects or failure to meet published specifications; (B) the defective unit or part is returned to the Company, transportation charges prepaid by Buyer; (C) the defective unit or part is received by the Company for adjustment no later than four weeks following the last day of the warranty period; and (D) the Company’s examination of such unit or part shall disclose, to its satisfaction, that such defects or failures have not been caused by misuse, neglect, improper installation, unauthorized repair, alteration or accident. Any authorization of the Company for repair or alteration by the Buyer must be in writing to prevent voiding the warranty. In no event shall the Company be liable to the Buyer for loss of profits, loss of use, consequential damage or damages of any kind based upon a claim for breach of warranty, other than the purchase price of any defective product covered hereunder. The Company warranties as herein and above set forth shall not be enlarged, diminished or affected by, and no obligation or liability shall arise or grow out of the rendering of technical advice or service by the Company or its agents in connection with the Buyer's order of the products furnished hereunder. Limitation of Liabilities This warranty does not cover normal maintenance such as cleaning, adjustment or lubrication and updating of equipment parts. This warranty shall be void and shall not apply if the equipment is used with accessories or parts not manufactured by the Company or authorized for use in writing by the Company or if the equipment is not maintained in accordance with the prescribed schedule of maintenance. The warranty stated above shall extend for a period of One (1) year from date of shipment, with the following exceptions: 1. 2.

Components for monitoring of physical variables such as temperature, pressure, or flow are warranted for ninety (90) days from date of receipt. Elastomeric components and other parts or components subject to deterioration, over which the Company has no control, are warranted for sixty (60) days from date of receipt.

3.

Internal batteries are warranted for ninety (90) days from the date of receipt.

The foregoing is in lieu of any warranty, expressed or implied, including, without limitation, any warranty of merchantability, except as to title, and can be amended only in writing by a duly authorized representative of the Company.

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Contents Revision History ... iii Warranty ... vi Contents ... vii List of Figures ... viii Notices ... ix Chapter 1 Product Description ... 1 Chapter 2 Product Specifications ... 3 Chapter 3 Summary of Warnings and Cautions ... 7 Chapter 4 Unpacking and Setup ... 11 Chapter 5 Operation ... 23 Chapter 6 Operating Modes... 35 Chapter 7 Alarms and Indicators... 37 Chapter 8 Maintenance and Cleaning... 43 Chapter 9 Explanation of Symbols ... 45 Appendix A Product Configurations ... 49 Appendix B Pneumatic Diagram ... 51 Appendix C Alarm Troubleshooting ... 53 Appendix D Fault Management... 57 Glossary... 63 Index ... 65

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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 for 675-CFG-XXX when used with the Infant Flow variable-flow generator ... 15 Figure 6: Flow pressure nomogram for 675-CFG-XXX when used with the Infant Flow LP or AirLife variable-flow generator ... 16 Figure 7 Front Panel ... 23 Figure 8 Rear Panel ... 24 Figure 9 Setup Screen ... 28 Figure 10 Alarm set/confirm Screen ... 29 Figure 11 Mode Select Screen ... 29 Figure 15 NCPAP ... 35 Figure 16 BiPhasic ... 35 Figure 17 BiPhasic tr... 36 Figure 18 Flat Battery screen... 39

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Notices EMC Notice This equipment radiates and is susceptible to radio frequency energy. If not installed and used in accordance with the instructions in this manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in BS EN60601-1-2 for Medical Electrical Equipment Part 1-2: General requirements for safety-collateral standard, Electromagnetic compatibility – requirements and tests. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments (e.g. hospitals) described in this manual. This device is also designed and manufactured to comply with the following standards: Safety: UL 60601-1: 2003 Medical Electrical Equipment, Part 1: General Requirements for Safety. CAN/CSA C22.2 No 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety including C22.2 No. 601.1S1-94 (IEC6011, Amendment 1:1991) Supplement No. 1-94 to CAN/CSA 22.2 No. 601.1M90, EN ISO 21647 Electrical Safety: Class 1 equipment Contains type BF patient applied parts Continuous Operation

MRI Notice This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate this device in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the device.

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Electromagnetic Environment Specifications

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

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

Classification Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1 Protected, and uses type BF applied parts. Equipment is not suitable for use in presence of flammable anesthetics.

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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

EU Notified Body: BSI (Reg. No. 0086) Trade names: Infant Flow SiPAP Manufactured by: CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887-4668 If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion.

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Infant Flow SiPAP

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Chapter 1 Product Description Infant Flow™ SiPAP driver 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 SiPAP driver is currently available in a Plus or Comprehensive* configuration. The Plus configuration provides NCPAP and time triggered BiPhasic modes with and without breath rate monitoring. The Comprehensive* configuration offers these features plus a patient triggered BiPhasic mode with apnea backup breaths. The Infant Flow SiPAP driver comes standard in all configurations with an LCD touch screen display, pressure time waveform graphics, integrated patient monitoring, alarms for high and low pressure and FiO2 and up to 2 hours of backup battery power. As a result of the unique, patented design, the Infant Flow, Infant Flow LP or AirLife Infant nCPAP System Generators have been proven to provide the most stable CPAP at the lowest work of breathing for patients compared to other devices (1). The outstanding performance of variable flow generators is irrespective of patient demand or expiratory flows. The SiPAP driver has been designed and tested to perform optimally when used only with accessories available from CareFusion. These accessories include the variable flow generator, single limb breathing circuit, nasal prongs, nasal masks, and fixation device, either bonnet or headgear.

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 (2,3). 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. Infant Flow, Infant Flow LP, or AirLife Infant nCPAP System Generator – The Infant Flow Generator is a fluidic device for the generation of consistent infant nasal CPAP with a low work of breathing compared to other devices(1). 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.

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Chapter 1 Product Description

Battery Backup – Up to 2 hours of battery backup allows for intra-hospital transport. Clear indicators are provided for power supply in use (AC or DC), and battery charge level. Screen Lock – After 120 seconds of no screen inputs, the screen changes to the Locked Screen to prevent inadvertent changes. Upon activation of a high priority alarm the screen changes to an unlocked state to allow access to controls. Table 1 Functions and Accessories Functions and 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 Pulmonology: 26 (5): 349-53; 1996

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

•

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

•

%O2 – 21 -100%

Monitors •

CPAP

•

PEEP

•

MAP

•

PIP

•

%O2

•

I:E ratio

•

Spontaneous rate (Rsp)

•

Battery charge level

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Chapter 2 Product Specifications

Alarms •

High airway pressure – 3 cmH2O above measured airway pressure

•

Airway over-pressure limit alarm • maximum 11 cmH2O in NCPAP and time triggered BiPhasic mode • maximum 15 cmH2O in patient triggered BiPhasic tr mode

•

Low airway pressure – 2 cmH2O below measured airway pressure or 1.5 cmH2O 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

•

Range: 4.8 to 6 bar (40.6 to 87 PSI); Maximum differential pressure 2 bar, (30 psi)

•

Manometer: Range 0 to + 20 cmH2O, accuracy, ± 2% of span

•

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

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Atmospheric and Environmental •

Temperature Range • Operating: 5 to 40° C • Storage: - 20 to 60° C

•

Relative Humidity -Operating: 0 to 95% non-condensing

•

Storage: 0 to 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 cmH2O at 15 LPM, and less than 0.40 cmH2O at 5 LPM.

SiPAP Gas Monitor •

Total system response time: 8.61 seconds

•

Drift: No drift after six hours of operation

•

Cyclical pressure: Up to 10 Kpa (100 cmH2O)-has no effect on the gas monitor accuracy

•

Accuracy of the oxygen reading at 30, 40 and 60%: No drift when cycling the ventilator

•

With non-diverting flow at 10 mL/min at a pressure of 60 Kpa (60 cmH2O), the ventilator and sensor show no leaks.

•

The gas monitor uses the internal battery and is not affected by power interruptions or fluctuations of the external power.

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Infant Flow SiPAP

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Infant Flow SiPAP

Chapter 3 Summary of Warnings and Cautions Please review the following safety information prior to operating the Infant Flow SiPAP driver. Attempting to operate this equipment without fully understanding its features and functions may result in unsafe operating conditions. Warnings and Cautions, which are general to the use of the device under all circumstances, are included in this section. Some Warnings and Cautions are also inserted within the manual where they are most meaningful. Notes are also located throughout the manual to provide additional information related to specific features. If you have a question regarding the installation, operation, or maintenance of the device, contact CareFusion (see page ii).

Terms WARNINGS identify conditions or practices that could result in serious adverse reactions or potential safety hazards. CAUTIONS

identify conditions or practices that could result in damage to the driver or other equipment.

NOTES

identify supplemental information to help you better understand how the driver works.

Warnings •

Infant Flow SiPAP driver is intended for use by a trained practitioner, under the direct supervision of a qualified physician.

•

When the Infant Flow SiPAP driver is connected to a patient, a trained health care professional should be in attendance at all times to react to an alarm or other indications of a problem.

•

Always have an alternate means of ventilation available whenever the Infant Flow SiPAP driver is in use.

•

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

•

Water in the air supply can cause this equipment to malfunction. Check the water trap at least every 24 hours (more frequently if needed, depending on amount of water in the air supply).

•

The operator should not touch the electrical connectors of the Infant Flow SIPAP driver or its accessories, and the patient simultaneously.

•

An audible alarm indicates an anomalous condition and should never go unheeded.

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