TSI Instruments Certifier 4090-AC User Manual

Pro flow analyzer test system

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Certifier

Pro Flow

Analyzer Test System

Model 4090

User Manual

P/N 6016808, Revision D

December 2024

www.tsi.com

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Page 1 ™ Certifier Pro Flow Analyzer Test System Model 4090 User Manual P/N 6016808, Revision D December 2024 www.tsi.com...
Page 2 Start Seeing the Benefits of Registering Today! ® ® Thank you for your TSI instrument purchase. Occasionally, TSI releases information on software updates, product enhancements ® and new products. By registering your instrument, TSI will be able to send this important information to you. http://register.tsi.com As part of the registration process, you will be asked for your comments on TSI products and services.
Page 3: Warranty
Warranty Copyright TSI Incorporated / 2023-2024 / All rights reserved. Address TSI Incorporated / 500 Cardigan Road / Shoreview, MN 55126 USA W A R N I N G Certifier™ Flow Analyzers employ a heated platinum sensor. They SHOULD NOT ®...
Page 4 OF DIRECT INFRINGEMENT AND EXCLUDES CLAIMS OF CONTRIBUTORY OR INDUCED INFRINGEMENTS. BUYER’S EXCLUSIVE REMEDY SHALL BE THE RETURN OF THE PURCHASE PRICE DISCOUNTED FOR REASONABLE WEAR AND TEAR OR AT SELLER’S OPTION REPLACEMENT OF THE GOODS WITH NON-INFRINGING GOODS. TO THE EXTENT PERMITTED BY LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE LIMIT OF SELLER'S LIABILITY FOR ANY AND ALL LOSSES, INJURIES, OR DAMAGES CONCERNING THE GOODS (INCLUDING CLAIMS BASED ON CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) SHALL BE THE RETURN OF GOODS TO SELLER AND THE REFUND OF THE PURCHASE PRICE, OR, AT THE OPTION OF SELLER, THE REPAIR OR...
Page 5: Table Of Contents
Contents Warranty ................................iii Contents ................................v CHAPTER 1 Introduction and Parts Identification ................... 1-1 Introduction ............................1-1 High Flow Channel ..........................1-1 Low Flow Channel ..........................1-1 Pressure Measurements ........................1-1 Oxygen Concentration ........................1-1 Anesthesia Sensor ..........................1-1 List of Standard Components .......................
Page 6 Pre-Test Checks ........................... 3-4 Flow Measurement ..........................3-4 Flow Directional Sensor ........................3-4 Low-Pressure and High-Pressure Transducer Zeroing ..............3-4 Oxygen Sensor Calibration ........................ 3-4 Flow Compare ............................ 3-5 CHAPTER 4 Touchscreen Operation ......................4-1 Display Interface Overview ........................4-1 Parameter Screen ..........................
Page 7 Replacing the Oxygen Sensor ......................6-3 Cleaning the Flow Analyzer ........................6-3 Factory Calibration (recommended annually) ..................6-4 Return Procedure ..........................6-4 CHAPTER 7 Specifications .......................... 7-1 Physical ..............................7-1 Environmental ............................7-1 Power ..............................7-1 Compliance ............................7-1 Measurements ............................7-2 Certifier™...
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Page 9: Chapter 1 Introduction And Parts Identification
CHAPTER 1 Introduction and Parts Identification Introduction The Certifier™ Pro Flow Analyzer is a multi-functional pneumatic test system designed for biomedical professionals to test respiratory medical equipment such as mechanical ventilators, anesthesia machines, PAP devices, oxygen concentrators, air-oxygen blenders, and insufflators. The Certifier™ Pro Flow Analyzer is used in manufacturing, hospital, field service, research, laboratory, and home care settings.
Page 10: List Of Standard Components
List of Standard Components Carefully unpack the test system components from the shipping container. Check the individual parts ® against the packing list and notify TSI immediately if any parts are missing or damaged. Certifier™ Pro Flow Analyzer Test System (Model 4090) Item Replacement Number...
Page 11: List Of Optional Accessories
List of Optional Accessories Description Part Number Image Carrying Case, Fitted for the 130378 Certifier™ Pro Flow Analyzer 19 x 14.75 x 6.5 inches (48 x 37.5 x 16.5 cm) Test Lung, Adult, 1.0L, includes 130396 elbow connector 15 mm ID x 22 mm OD Test Lung, Pediatric, 0.5L, includes one 130397 elbow connector and two straight...
Page 12: Anesthesia Sensor Kit (Model 4093)
Anesthesia Sensor Kit (Model 4093) Item Description Part Number Qty. Anesthesia Sensor Cell (with DB-9 connector cable) 130386 Anesthesia USB Serial Converter 130402 Anesthesia Airway Adapter, Adult/Pediatric 130403 Refer to the Anesthesia Sensor Kit User Manual for more detailed information. Flow Resistor Kit (PN 130395) Flow resistors are calibrated airway adapters used to simulate nominal levels of resistance.
Page 13: Hanging Clip (Pn 130395)
Hanging Clip (PN 130395) Used to hang the Certifier™ Pro instrument by its handle from a ventilator rail (the Hanging Clip is included as part of the Certifier™ Pro 4090 Kit). Mobilize™ Integration Chip (PN 130401) Plug-in dongle that enables the Certifier™ Plus Flow Analyzer to wirelessly communicate with the Mobilize™...
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Page 15: Chapter 2 Flow Analyzer Overview
CHAPTER 2 Flow Analyzer Overview Instrument Overview Model 4090 Instrument, Front Low Flow Channel Inlet Low Differential Pressure, Positive Port (+) High Flow Channel Inlet Low Differential Pressure, Negative Port (-) High Pressure Port (Max: 150 psi / 10 bar) Touchscreen Display Model 4090 Instrument, Back Low Flow Channel Outlet...
Page 16: Model 4090 Instrument, Bottom
Model 4090 Instrument, Bottom Battery/Oxygen Sensor Cover Rubber Feet Cover Knob Instrument Handle Cable Retainer The fan runs automatically based on the internal temperature of the instrument and cannot be controlled by the user. Operation Overview Flow Channels Measurements from both flow channels are available for simultaneous use. You can connect or disconnect your test circuit to or from the Certifier™...
Page 17: Lithium Ion Batteries
Lithium Ion Batteries The Certifier™ Pro Flow Analyzer utilizes a 4-cell lithium ion battery pack which can provide up to six (6) hours of continuous operation from a full charge. The battery pack is calibrated and installed into the instrument at the factory. The battery pack is rechargeable and can be charged internally by providing power via the AC power adapter.
Page 18: User Configurations
User Configurations A user configuration is a collection of setting values for the measurements, units, gas type and conditions, triggering, and graph settings that can be saved and recalled at a later time. This allows you to save and load different test setups for specific models of equipment or to ensure test setups conform with organizational standards or personal preference.
Page 19: Data Acquisition And Export
Data Acquisition and Export The Certifier™ Pro Flow Analyzer is capable of logging measurement data and capturing screenshots. Files are saved to the internal memory of the Certifier™ Flow Analyzer and can be exported through either of its two USB-A ports. Saved measurement data is exported as .csv files and screenshots are exported as .png files.
Page 20: Measurements And Units
Measurements and Units Available Measurement Parameters Some of the parameters listed are only available from the high flow channel. Symbol Description Symbol Description Plateau pressure – pressure at Flow rate PLAT the end of the inspiratory phase during no flow (4081 only) Peak flow rate –...
Page 21: Available Units Of Measurement
Available Units of Measurement Measurement Factory Default Units Optional User-Selectable Units V , V L/min mL/min, mL/s PEAK mL, L , V, MV kPa, Pa, hPa, mbar, mmHg, P, PIP, P O, PSI Δ PLAT kPa, bar HIGH O, Pa, hPa, mbar, bar, mmHg, PSI, inH kPa/s, Pa/s, hPa/s, mbar/s, mmHg/s, PSI/s, inH...
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Page 23: Chapter 3 Flow Analyzer Setup
CHAPTER 3 Flow Analyzer Setup Getting Started Power On/Off Press the power button located on the back of the Certifier™ Pro Flow Analyzer once to turn the instrument on. With the device powered on, press the power button once to begin the controlled shutdown procedure.
Page 24: Breath Triggers
Breath Triggers The Certifier™ Pro Flow Analyzer uses triggers to define start of the inspiratory and expiratory cycles. Triggers are based on the flow rate, pressure, or from a TTL voltage signal. The Certifier™ Flow Analyzer is set as its trigger default to automatically detect the breath cycles (using flow rate), but you can also set your own start and end trigger values.
Page 25 Ventilator Test circuit for bi-directional flow Flow Analyzer Overview...
Page 26: Pre-Test Checks
Pre-Test Checks Flow Measurement To ensure proper operation of the system for safety, ensure the instrument’s flow calibration date is valid. If the calibration due date is approaching or past according to the factory attached label, return ® the instrument to TSI for calibration.
Page 27: Flow Compare
Flow Compare The Flow Compare feature provides an indication of flow accuracy by comparing the flow rate measurement of the low flow channel to the flow rate measurement of the high flow channel. The Flow Rate Delta parameter (shown below left) displays the difference in readings in a discreet value. The Flow Rate Delta Percent parameter (shown below right) displays the difference in flow rate readings as a percentage.
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Page 29: Chapter 4 Touchscreen Operation
CHAPTER 4 Touchscreen Operation Display Interface Overview The two primary screens on the Dashboard of the Certifier™ Pro Flow Analyzer are the Parameter Screen and the Graph Screen. The top, bottom, and right bars are always present on both screens. Edits made to the instrument through any of these bars apply to the entire instrument regardless of the screen in which you make changes from.
Page 30 Option Description An “L” in the low flow channel card and an “H” is displayed in the high flow 3. Module Indicator channel card. These letters correspond to the letters displayed for each measurement and are used to signal from which flow channel the readings are made.
Page 31: Warnings And Errors
Warnings and Errors Descriptions of any active warnings or errors can be viewed in the Active Warnings and Errors screen. Errors are shown highlighted in red, whereas warnings are not highlighted. You can clear warnings manually in this screen if desired. Errors can only be cleared if you take appropriate steps to resolve the error state or if the Certifier™...
Page 32: Graph Screen
Graph Screen 1. Plotted Measurements 4. Trigger Indicators 2. Y-Axis 5. Real-time Measurements 3. X-Axis 6. Edit Graph Option Description 1. Plotted Displays current values for the selected measurements and their units and Measurements plots the measurement on the graph. You can graph up to two measurements at a time.
Page 33: Channel Cards
Channel Cards A card is shown in the black header bar for both the high flow and low flow channels. Upon pressing a channel card, you will be able to edit gas type or gas condition settings for that particular module. Gas Type options available on the Certifier™...
Page 34: Menu Screen
Menu Screen The menu can be accessed from either the Parameter screen or Graph screen. Menu Description Dashboard Closes the Menu options and returns you to the previous screen. Manage Data Enters screen where you can organize, preview, export, and delete saved data.
Page 35 Press the (+) ADD tile to select an additional measurement, or press the measurement symbol of a currently selected measurement to change that measurement parameter. Once pressed, a list of available measurements will be displayed in alphabetical order (see below left). An H is displayed in the upper left to indicate the measurement is coming from the high flow channel, and an L is displayed for measurements coming from the low flow channel.
Page 36: Gas Type And Gas Condition
To remove a measurement from being displayed on the Parameter screen, press the X located next to the units for that measurement. Press the orange X button in the right navigation bar at any time to disregard all changes and return to the Parameter screen.
Page 37: Breath Triggers
Gas condition options available on the Certifier™ Flow Analyzer: Option Description Actual Temperature and Pressure. The gas flow rate and volumes at the actual temperature and pressure of the gas. ATP is the default gas condition for the Certifier™ Flow Analyzer. Standard Temperature and Pressure.
Page 38 Flow Rate – Manual Triggers If auto-triggering is not providing reasonable results, consider using manual flow triggering. Press the Auto Trigger box to unselect it and be able to specify flow rate values for the start and end of the breath.
Page 39: Averaging
TTL Trigger The start and end of the breath can also be triggered by a TTL voltage signal given at the connector on the Certifier™ Pro High Flow Module labeled “Trigger Input”. This is only available for the 4081 High Flow Module. The connector is a 3.5 mm mono audio jack plug. To trigger using TTL voltage, select the Flow Direction (TTL) radio button option and select the TTL voltage.
Page 40: Using Configurations
Using Configurations A configuration is a collection of Certifier™ Flow Analyzer settings that can be saved to internal memory and later recalled. This allows you to save and use specific setups to test different equipment, to comply with organizational test standards, or for personal preferences. Configurations record the measurements and units selected, gas calibrations, gas conditions, triggers and averaging, and graph setup.
Page 41: Loading Configurations
The check boxes are used to select multiple files so you may export or delete more than one configuration at a time. Press a check box to select and press again to deselect. Press the checkbox in the Name column heading to select all configuration files. NOTICE The Default configuration file cannot be overwritten, renamed, exported, or deleted.
Page 42: Saving Configurations
Saving Configurations To save the current Certifier™ Pro Flow Analyzer setup as a configuration, navigate to the Local tab of the Configurations screen and click the save (disk) icon. A pop-up screen provides the options to overwrite the active configuration [SAVE] or to create a new configuration [NEW]. NOTICE Only one configuration file can be saved at a time, the check boxes are not used for saving configurations.
Page 43: Exporting Configurations
Exporting Configurations Configurations are stored in the internal memory of the Certifier™ Pro Flow Analyzer and can be exported from either of the two USB-A ports located on the back of the instrument. To export one or more configurations, insert a USB flash drive into the Certifier™ Flow Analyzer and navigate to the Local tab of the Configurations screen.
Page 44: Importing Configurations
Importing Configurations The Certifier™ Pro Flow Analyzer can import configurations from a USB flash drive inserted into either of the two USB-A ports located on the back of the instrument. The Certifier™ Flow Analyzer will recognize any configuration files and display them in the External Configurations tab. To import a single configuration, either click on the 3-dot menu of that particular configuration file and select the Import menu option, or check the corresponding box and press the export icon (down arrow).
Page 45: Plotted Measurements
Plotted Measurements Either 1 or 2 measurements can be plotted on the graph at a time. The primary measurement is displayed on the left side of the screen and the secondary measurement on the right. The color of the borders around the plotted measurements in the edit screen correspond to the colors shown for the Y-axes and traces on the graph.
Page 46: Y-Axis Scaling
Y-Axis Scaling Scaling for the Y-axis is displayed in the same units as those selected for the plotted measurement. The color of the borders around the Y-Axis Scales in the edit graph screen correspond to the colors shown for the Y-axes and traces on the graph. The Y-axis is set to scale automatically as the default.
Page 47: Trigger Indicators
Trigger Indicators When enabled, the trigger timing being used by the Certifier™ Flow Analyzer to define the breath cycles will be shown on the graph as vertical lines. The first (green) line indicates the start of the inspiratory phase, and the second (red) line indicates the start of the expiratory phase of the breath cycle.
Page 48: Zeroing And Calibration
To remove a measurement from being displayed on the Parameter screen, press the X located next to the units for that measurement. Press the orange X button in the right navigation bar at any time to disregard all changes and return to the Parameter screen.
Page 49: Calibrate Oxygen Sensor
After zeroing, a status is displayed for each pressure sensor to indicate the result of the zero process. The pressure sensors can be zeroed more than once by you while in the Zero Pressure Sensors screen. Press the DONE button to return to the Certifier™ dashboard screen. NOTICE The barometric pressure sensor (used for absolute pressure measurements) does not require zeroing;...
Page 50: Set Installation Date
Set Installation Date You can input a date in order to keep an on-instrument record of the installation for the oxygen sensor. Press the Set Installation Date button, select a date in the calendar pop-up window, and Save. Data Logging and Export The Certifier™...
Page 51 Snapshot The Snapshot feature saves a screenshot image as well as saves the data currently displayed on the screen, either from the Parameter screen or Graph screen. Upon executing a snapshot, the Certifier™ Flow Analyzer will create two files, an image file for the screen capture and a data file with a single data point.
Page 52 Continuous Logging Continuous logging initiated from the Parameter screen will save data for the measurements currently selected on screen. Initiated from the Graph screen, Continuous will save data for the plotted graph measurements. The sampling rate at which data is collected can be set from 1 second to 10 minutes. The collection time can be set from 15 seconds to up to 5 days (120 hours) of continuous logging.
Page 53: Managing Data
Cancel/Stop an Active Log The Certifier™ display is disabled while actively collecting data from a Continuous or Waveform log, and you can only toggle between the Parameter and Graph screens during this time. The collection time remaining is shown counting down on the left side of the header bar (circled in green below). During active logging the right navigation bar will populate buttons for you to cancel or stop logging (circled below in red).
Page 54 The Manage Data screen lists all the individual saved data files and screenshots available to the user. The Data Type column corresponds to the Certifier™ logging options and files are labeled as either Snapshot, Continuous, Waveform, or Graph. The # of Samples column denotes the number of data points collected for each file and equals the sampling rate multiplied by the collection time.
Page 55 In the File Preview screen, you can preview screen captures or logged data in graph form. For data log files, the preview screen displays the number of data points collected, log start time, total logging time, sampling rate, the active configuration, comments, and the module from which the data came from.
Page 56: Exporting Data
Delete Saved Files In the Manage Data screen, use the check boxes to select one file or multiple files. Press a check box to select and press again to deselect. Click the check box in the heading to select all files. Press the delete button (garbage can icon) to delete selected files;...
Page 57: Viewing Exported Data
Viewing Exported Data ® ® Exported .csv files can be opened and viewed within Microsoft Excel or an equivalent spreadsheet program. See Appendix A for examples of exported data formats for Snapshots, Continuous, and Waveform data logs. NOTICE The cell in the “Time” column will need to be reformatted in order to display properly. To format: 1.
Page 58: Device Settings
Device Settings Access the device settings by choosing the Settings option from the Menu drop-down. From this screen, you can select which functional settings to view and adjust. General Settings In this screen you can set the Export Delimiter and Decimal format for the Certifier™ instrument. The export delimiter is used to specify how exported data is separated on the .csv file.
Page 59: Flow Channel Power Toggles
Flow Channel Power Toggles The default mode for the Certifier™ Pro Flow Analyzer is to always power on both flow channels. In order to reduce power consumption and extend battery operation, you have the option to turn either flow channel off. The high flow channel controls flow or pressure triggers as the default. Power off the high flow channel in order for the low flow channel to control triggering for the Certifier instrument.
Page 60: Device Information
Device Information The device information screen displays information about the Certifier™ Pro instrument. Access this screen by selecting the Device Information option from the menu drop-down. The Version field lists the firmware version currently implemented for the Certifier™ Pro Flow ®...
Page 61: Chapter 5 Troubleshooting
CHAPTER 5 Troubleshooting The table below lists the symptoms, possible causes, and recommended corrective actions for problems that may be encountered while operating the Certifier™ Pro system. If the symptom is not listed or if none of the recommended corrective actions solve the problem, contact technical support at technical.services@tsi.com or customer support at 800-680-1220 or 651-490-2860 for assistance.
Page 62 Symptom Possible Cause Corrective Action Oxygen sensor 21% oxygen and/or 100% Verify that calibration gases are calibration fails. oxygen not supplied for 21% and 100% O and repeat calibration. Oxygen sensor is calibration. Replace oxygen expired. Non-steady flow or sensor. Use constant flow rates tidal flows used.
Page 63: Chapter 6 Maintenance
CHAPTER 6 Maintenance Recharging the Battery The fastest charging method is to charge the internal batteries with the Certifier™ Pro Flow Analyzer Test System turned off. With new batteries and the Certifier™ instrument turned off, the charging time to go from empty to a full charge is approximately four hours. When connected to AC power, the Certifier™...
Page 64: Battery Calibration
To install a battery into the Certifier™ Pro Flow Analyzer: 1. Turn the Certifier™ instrument off and disconnect any cables. 2. Remove the back plate and plug the battery pigtail connector into the Certifier™ Pro Flow Analyzer. 3. Lift the retainer plate and insert the battery pack underneath, secure plate with one (1) screw. 4.
Page 65: Replacing The Oxygen Sensor
Replacing the Oxygen Sensor The oxygen sensor will function for one or more years of normal operation if use begins before the expiration date. Replace the oxygen sensor after every year or two of normal use, if the sensor cannot be calibrated, or if sensor readings are erratic.
Page 66: Factory Calibration (Recommended Annually)
4. Package the Certifier™ Pro Flow Analyzer carefully to avoid damage during shipping. Please note that it is not necessary to return accessories for calibration service. TSI Instruments Singapore Pte Ltd TSI Incorporated 150 Kampong Ampat 500 Cardigan Road...
Page 67: Chapter 7 Specifications
CHAPTER 7 Specifications Specifications are subject to change without notice. Physical Dimensions Instrument: 11 x 8.3 x 4.5 inches (27.9 x 21.1 x 11.4 cm) Flow connectors High Flow Channel: ▪ Inlet: 22 mm female ISO taper ▪ Outlet: 22 mm male ISO taper Low Flow Channel: ▪...
Page 68: Measurements
Measurements See additional notes listed at the end of the specifications. Measurement High Flow Channel Low Flow Channel V , V Flows PEAK Range -200 to +300 SLPM for air, oxygen, 0.01 to 20 SLPM for air, oxygen, nitrogen, and air/oxygen mixtures nitrogen, carbon dioxide, and nitrous oxide -40 to +40 SLPM for carbon dioxide...
Page 69 Measurement High Flow Channel Low Flow Channel P PIP P Low Pressures Δ PLAT Range -25 to +150 cm H Not available Accuracy ±0.5% of reading or ±0.15 cm H Not available whichever is greater Leak Rate Range ±30 cmH Not available Accuracy ±0.5% of reading or ±0.2 cmH...
Page 70: Certifier™ Pro Flow Analyzer Pressure Drop
Certifier™ Pro Flow Analyzer Pressure Drop Low Flow Channel High Flow Channel Certifier™ Pro Flow Analyzer Test System...
Page 71: Appendix A Data Export Formats
APPENDIX A Data Export Formats Snapshot Data File from the Parameter Screen NOTICE Snapshots initiated from the Parameter screen capture a single data point of the current reading for all measurements selected on the Parameter screen. Snapshot Data File from the Graph Screen NOTICE Snapshots initiated from the Graph screen capture all the data currently displayed in the graph at the time the “Save”...
Page 72: Continuous Log File (Initiated From The Parameter Screen Or Graph Screen
Continuous Log file (Initiated from the Parameter Screen or Graph Screen) Certifier™ Pro Flow Analyzer Test System...
Page 73: Waveform Log File (Initiated From The Parameter Screen Or Graph Screen
Waveform Log file (Initiated from the Parameter Screen or Graph Screen) NOTICE The cells in the “Time” column will need to be reformatted in order to display millisecond data. properly. To format the cells, select all the data in the column, select “Format Cells,” choose the Custom category, select h:mm:ss as the Type, and enter “.000”...
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Page 76 TSI Incorporated – Visit our website www.tsi.com for more information. Tel: +1 800 680-1220 India Tel: +91 80 67877200 Tel: +44 149 4 459200 China Tel: +86 10 8219 7688 France Tel: +33 1 41 19 21 99 Singapore Tel: +65 6595 6388 Germany Tel: +49 241 523030 P/N 6016808 Rev D ©2024 TSI Incorporated...

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