CareFusion
Infant Flow SiPAP Model M675 Service Manual Rev F April 2010
Service Manual
92 Pages
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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. © 2008 – 2010 CareFusion Corporation or one of its subsidiaries. All rights reserved Infant Flow SiPAP model M675 is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are property of their respective owners.
USA
Authorized European Representative
CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887-4668
CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg, Germany District Court Wuerzburg HRB7004
800.231.2466 tel +1.714.283.2228 tel +1.714.283.8493 fax
+49.931.4972.0 tel +49.931.4972.423 fax
carefusion.com
Literature number: 675–120 Revision F
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Revision History Date
Revision
Changes
September 2003
675-120(1)
Release
November 2004
B
Release manual in VIASYS Healthcare template using VIASYS Healthcare Respiratory Care nomenclature.
December 2004
C
Revised per EO 27980. Removed the picture from the title page. Deleted the ESD warning from page 19. Removed “O2 Sensor” and added the word “measured” on page 30. Changed “O2 sensor” to “fuel cell” on pages 39, 45, 62, 68, 69, 73, 86, and 87. Replaced the O2 senor row on page 50. Updated the error codes on pages 56 and 57. Replaced the warning on page 61. Changed the Fitting procedure on pages 64, 68, and 75. Changed step 6 on page 65. Added Addendum A – Oxygen Leak Test Changed Transducer Assy. To Transducer Interface on page 88.
May 2005
D
Revised per ECO 60329 Update address/contact info Update battery remove/install procedure Added note for fuel cell disposal Update check valve assembly remove/install procedure Update water trap & restrictor remove/install procedure Delete redundant leak test Update list of service parts
August 2008
E
Updated company information Updated company information Corrected Table 2 and updated Table 3 Updated Figure 6 Updated Figure 10 Updated the section “Diagnostics.” Updated Table 6 starting on page 43
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Date
Revision
Changes
April 2010
F
Changed Ti to T-High throughout Figure 5 - Diagnostic screen updated Spelling correction from “GRD” to “GND” Added “Note: transducer must be attached.” Changed “10 V” to “11.10 V” Updated Table 6 - Error Codes (E50 - E54) and added E55 Removed “Blender (Check Valves and Filter) Annually” from table 7. Added “, and two screws on the case-bottom”. Added “and document L2879” Replaced Ti symbol with T-High symbol Changed “PL5” to “PL2” Replaced Figure 3 Replaced Figure 4 and 5. Changed “value doesn’t” to “value on the external oxygen analyzer doesn’t”. Changed “467352” to “68289”; changed “777245” to “52700A”; removed items 677-005A, 675-311, S117635, 467461, 467460. Removed item S117641; changed “675-310” to “M675AFRONT”
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Warranty The Infant Flow® SiPAP is warranted to be free from defects in material and workmanship and to meet the published specifications for One (1) year from date of shipment. The liability of 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. 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. Internal batteries are warranted for ninety (90) days from the date of receipt.
3.
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 ... i Warranty ... v Limitation of Liabilities ... v Notices ... viii EMC Notice ...viii MRI Notice ...viii Intended Use Notice ... ix Regulatory Notice ... ix Classification ... ix Declaration of Conformity Notice ... x
Chapter 1 – Product Description ... 1 Chapter 2 – Product Specifications ... 3
Modes ... 3 Controls ... 3 Monitors ... 3 Alarms ... 4 Pneumatic Supply ... 4 Electrical Supply ... 4 Atmospheric & Environmental ... 5 Physical ... 5
Chapter 3 – Warnings and Cautions... 7
Terms ... 7 Warnings ... 7 Cautions ... 9
Chapter 4 – System Construction... 11
Touch Screen ... 15 Alarm Conditions ... 17 Diagnostic Screen... 17
Chapter 5 – Operation ... 19
Gas Flow ... 19 Electronic Functions ... 22 Electrical Layout ... 23 Fault Management ... 24
Chapter 6 – Operation ... 25
Preparing and Connecting the Equipment... 25 Switching On the IFSD... 28 Alarms Test ... 29 Infant Flow® SiPAP™ User Verification Test Checklist ... 31 Setting Up the Equipment ... 32 Setting the NCPAP Parameters ... 33
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Setting the BiPhasic Parameters ...34 Setting the Triggered BiPhasic Parameters...35 Calibration...37 Giving a Manual Timed Sigh ...37 Operation Without Electrical Power ...37 Fault Indications ...38 Diagnostics ...44
Chapter 7 – Maintenance ... 51 Cleaning ... 51 Maintenance ... 51
General ...51 Maintenance Frequencies ...52 Removal and Fitting of Case ...53 Removal and Fitting of Battery ...54 Removal and Fitting of Oxygen Filter ...55 Removal and Fitting of Fuel Cell Filter/Restrictor ...56 Removal and Fitting of the Fuel Cell ...57 Removal and Fitting of Blender and Components ...58 Removal and Fitting of Water Trap Filter ...62 Removal and Fitting of Case Bleed Filtered Restrictor ... 63 Removal and Fitting of PA Solenoid Valve ...64
Chapter 8 – Explanation of Symbols ... 65 Appendix A – Oxygen Leak Test ... 69 Appendix B – Product Configurations ... 73
Non-US Configuration Parameters ...73 US Configuration Parameters ...73
Appendix C – Spare Parts... 75 Appendix D – Pneumatics Assembly ... 79 Glossary... 81
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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 (IEC601-1, Amendment 1:1991) Supplement No. 1-94 to CAN/CSA 22.2 No. 601.1-M90
With regards to Electrical Safety: Class 1 equipment Contains type BF patient applied parts Continuous Operation
MRI Notice This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate this device in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the device.
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Intended Use Notice The Infant Flow® SiPAP, consisting of a Driver and Generator plus NCPAP Prongs and Masks, is a medical device intended for the provision of Bi-Level CPAP to produce a sigh. This system is for use in Hospital, Hospital Type facilities and intraHospital transport environments and is indicated for the treatment of Newborn and Infant patients. Operators of this equipment and Service Engineers are required to read and thoroughly understand the contents of this manual before using or maintaining the equipment. This manual is intended for use by a competent, fully qualified Service Engineer. It includes a description of the unit and how it works. It also contains operating and diagnostic procedures and maintenance instructions. For usage of associated equipment, refer to the Manufacturer’s literature.
Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician.
Classification Type of Equipment: Medical Equipment, Class 1 and internally powered, IPX1 Protected, and uses type BF applied parts. Equipment is not suitable for use in presence of flammable anesthetics.
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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: Council Directive(s): MDD 93/42/EEC Annex II (excluding section 4) Safety: EN 60601-1, EN 794-1 EMC: EN 60601-1-2:2001 Conformity Assessment: MDD Annex II Quality System: ISO 13485 EU Notified Body: BSI (Reg. No. 0086) Device Classification: IIb
EU Notified Body: BSI (Reg. No. 0086) Trade names: Infant Flow SiPAP Manufactured by: CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887, USA If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion.
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Chapter 1 – Product Description The Infant Flow® SiPAP is a non-invasive form of respiratory support designed for use in hospital environments such as Neonatal and Pediatric Intensive Care Units. It can also be used when transporting patients within the hospital environment. The Infant Flow® SiPAP 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 patient BiPhasic mode with apnea backup breaths. The Infant Flow® SiPAP 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® SiPAP has been proven to provide the most stable CPAP at the lowest work of breathing for patients compared to other devices. The outstanding performance of the Infant Flow® SiPAP is irrespective of patient demand or expiratory flows. This system has been designed and tested to perform optimally when used only with accessories available from CareFusion. These accessories include circuits and generators, prong and mask patient interfaces and bonnets.
Infant Flow® SiPAP Features The expanded capabilities of the Infant Flow® SiPAP Plus and Comprehensive configurations allow for applications to broader range of patients who may otherwise not be candidates for non-invasive respiratory support. NCPAP – allows for continuous positive airway pressure based on clinician set pressure. Breath rate monitoring/alarm can be activated in this mode. BiPhasic - allows for time triggered pressure assists to be delivered based on clinician set inspiratory time, rate, and pressure criteria. Breath rate monitoring/alarm can be activated in this mode. BiPhasic tr* - allows for patient triggered pressure assists to be delivered based on clinician set inspiratory time and pressure criteria. Breath rate monitoring/alarm, and Apnea backup breaths are automatically active in the mode. Patented Infant Flow® 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. Fully integrated alarms packages – . Supply gases failure, High Patient Pressure, Low patient pressure, high and low delivered Oxygen concentration, change from AC to DC power source, low and flat battery charge status and Low breath rate/apnea alarm. 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.
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Screen Lock - After 120 seconds of no screen inputs, the screen changes to the Locked Screen to prevent inadvertent changes. Upon activation of a high priority alarm the screen changes to an unlocked state to allow for immediate interventions as required. Table 1 - Functions and Accessories Functions & Accessories 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
Plus
Comprehensive*
• •
• •
• •
• •
• • • •
• • • • • •
*Comprehensive configuration not available for sale in the United States
CAUTION The Infant Flow SiPAP™ has been designed and tested as a complete system using Infant Flow™ accessories. Only accessories approved for use should be used. If in doubt, please contact your local CareFusion representative.
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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
Controls •
Inspiratory Time (T-High): 0.1-3.0 seconds
•
Rate (R): 1-120 (Comprehensive only. The comprehensive configuration is not available for sale in the United States.)
•
Rate (R): 1-54 (Plus only)
•
Apnea Interval (Tapnea): 10-30 seconds, 5 second intervals (Comp* only)
•
Apnea Interval (TLBR): 10-30 seconds, 5 second intervals (Plus only)
•
NCPAP/Pres Low flowmeter: 0-15L/min, accuracy +/- 15% of selected output
•
NCPAP/Pres High flowmeter: 0-5L/min, accuracy +/- 15% of selected output
•
Manual Breath: X 1
•
Rate monitoring on/off: NCPAP
•
%O2: 21 - 100% - accuracy +/-3%
Monitors •
CPAP
•
PEEP
•
MAP
•
PIP
•
%O2
•
I:E ratio
•
Spontaneous rate (Rs)
•
Battery charge level
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Alarms •
High airway pressure – 3 cmH20 above measured airway pressure
•
High circuit pressure – maximum 11 cmH20 in time triggered Biphasic mode
•
High circuit pressure – maximum 15 cmH20 in patient triggered Biphasic tr mode (Comprehensive only. The comprehensive configuration is not available for sale in the United States.)
•
Low airway pressure – 2 cmH20 below measured airway pressure or 1 cmH20 if otherwise would be zero
•
High and Low delivered Oxygen concentration +5% of setting
•
Low breath rate alarm
•
Low or Flat battery charge level
•
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: 2.8 to 6 bar (40 to 90 psi); maximum differential pressure 2 bar (30 psi)
•
Manometer: Range 0 to + 20 cmH2O, accuracy, ± 2% of span
•
Gas Connections: Standard DISS or NIST 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 & Environmental •
Temperature Range-Operating: 5 – 40° C
•
Storage: 0 - 50° C
•
Relative Humidity -Operating: 0 – 90% non-condensing
•
Storage: 0 – 90% non-condensing
Physical •
Dimensions (driver only)-(W x H x D) 26 x38 x 23.5 cm / 10.25 x15 x 9.25 in
•
Weight (driver only)-8.8 kg / 19.5 lb
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Chapter 3 – 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 technical support at CareFusion.
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 ventilator or other equipment.
NOTES
identify supplemental information to help you better understand how the ventilator works.
Warnings •
Whenever a patient is attached to respiratory care equipment, constant attendance is required by qualified personnel. The use of an alarm or monitoring system does not give absolute assurance of warning for every malfunction that may occur in the system. In addition, some problems may require immediate attention.
•
The gas blender incorporated in this product is designed to mix medical grade air and oxygen only. Do not modify the inlets to accommodate other source gases such as anesthetic gases.
•
Check that the water trap is empty before use and empty it frequently during use.
•
Liquid water or other contaminants in either gas supply, particularly the air supply, may cause malfunction of this equipment and equipment connected to it.
•
When filling a humidifier, do not move the stand. Moving or transporting the stand while refilling may cause the stand and equipment to over balance.
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•
Do not use conductive patient circuits with the Infant Flow SiPAP Driver.
•
Nasal CPAP can cause nasal irritation, septal distortion, skin irritation and pressure necrosis. Observe the usage guidelines to minimize these complications.
•
This device exhausts O2 during normal operation. Oxygen vigorously accelerates combustion. To avoid fire hazard, do not place flammable materials or sources of heat close to the exhaust.
•
Do not use the equipment without the exhaust tube fitted (refer to Figure 2).
•
To reduce trip hazard, always ensure cable and tubes are restrained away from walking areas.
•
The Abdominal Respiratory Sensor will not detect all forms of apnea. Independent monitoring should always be used with this device.
•
If the unit is shelf mounted, ensure that the unit is stable and that hoses and cables are restrained to avoid hazard of toppling.
•
This equipment is not suitable for use in the presence of a flammable anesthetic mixture.
•
The NCPAP Pres High flowmeter must be adjusted to zero when not required for the patient.
•
Under extreme conditions (minimum supply pressure and maximum gas demand, including auxiliary output) output flow rates and delivered pressure may be reduced.
•
Only use the supplied AC cable to connect to the power supply.
•
Do not attach the Generator to the patient until the initial set up is complete.
•
The indicates a connection between the transducer interface and the unit. It does not indicate correct positioning of the Abdominal Respiratory Sensor.
•
Calibration must only be done when the unit is not connected to the patient.
•
Verify that the displayed value for delivered FiO2 corresponds to the value set on the blender. Refer to Faults and Indications.
•
Oxygen vigorously accelerates combustion. To avoid explosion hazard, do not use any instrument or other equipment that may have been exposed to oil or grease contamination.
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Cautions •
Federal Law (USA) restricts this device to sale by or on the order of a physician.
•
The precision gas blender in this product may become non-functional or damaged if used without the protective water trap and filters provided.
•
The power switch on this unit does not isolate the external power supply. Disconnect the power supply cable to ensure complete isolation.
•
Before use, verify that this equipment has been authorized for use by a qualified person.
•
The Infant Flow SiPAP™ has been designed and tested as a complete system using Infant Flow™ accessories. Only accessories approved for use should be used. If in doubt, please contact your local CareFusion representative.
•
Where the integrity of the external protective earth conductor is in doubt, the equipment shall be powered by its internal power source (battery).
•
Do not immerse any part of the IFSD in water or sterilize it with gas or steam.
•
Ensure patient breathing circuit is replaced at regular intervals.
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Chapter 4 – System Construction CAUTION Where the integrity of the external protective earth conductor is in doubt the equipment shall be powered by its internal power source (battery). The IFSD is AC powered with an integral rechargeable DC battery that provides power for up to two hours without any interruption of performance or function. If the AC power supply fails or is disconnected, the IFSD automatically switches to battery power and gives an audio and visual alarm. The IFSD is enclosed in a case with Operator controls and input connectors on the front and rear panel. The front panel is shown in Figure 1. The back panel is shown in Figure 2. The case incorporates non slip feet for table top use or must be fitted to a dedicated stand. The major components within the casing are: •
a gas module
•
an electronics module
•
a front panel module
•
a patient trigger module
•
a firmware module
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Figure 1: IFSD Front Panel
Gas Module The function of the gas module is to take air and oxygen, blend them into the required mixture and deliver this mixture to the patient at the prescribed flow rate. The gas module also measures the oxygen concentration, measures the patient pressure, provides an auxiliary gas outlet (optional) and provides switched Biphasic flow. The main components are an air/oxygen blender, a flow manifold, a vent valve, an exhaust manifold with alarm whistle, NCPAP Pres low and NCPAP Pres high flowmeters, and a valve/sensor PCB. The inlet gas connections are on an interchangeable inlet block to allow for different gas fittings. The exhaust manifold discharges gas to the outside of the case and is positioned away from the electrical connectors and switch to reduce any potential explosive hazard.
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Electronics Module The function of the electronics module is to power the unit either by AC mains supply or DC emergency battery supply, to control the gas module and read the gas module sensors. The main components are a power supply unit, a rechargeable battery, a main processor PCB, LED PCB, Valve/Sensor PCB and a LCD screen (touch screen). The LCD screen includes a back-light which is always on when the IFSD is powered. The touch screen displays information and receives inputs from the Operator via the touch screen keyboard.
Leak Test Port
Figure 2: IFSD Back Panel
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