Related Manuals for TSI Instruments Certifier Plus 4080-F
Summary of Contents for TSI Instruments Certifier Plus 4080-F
- Page 1 ™ Certifier Plus Flow Analyzer Test System User Manual P/N 6016477, Revision B June 2022 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.
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Page 3: Warranty
Warranty Copyright TSI Incorporated / 2022 / All rights reserved. Address TSI Incorporated / 500 Cardigan Road / Shoreview, MN 55126 USA W A R N I N G ® flow meters employ a heated platinum sensor. They SHOULD NOT be used with flammable or explosive gases or mixtures. - Page 4 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 REPLACEMENT OF THE GOODS. IN THE CASE OF SOFTWARE, SELLER WILL REPAIR OR REPLACE DEFECTIVE SOFTWARE OR IF UNABLE TO DO SO, WILL REFUND THE PURCHASE PRICE OF THE SOFTWARE.
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Page 5: Table Of Contents
Contents Warranty ................................iii Contents ................................v CHAPTER 1 Introduction and Parts Identification ................... 1-1 Introduction ............................1-1 Interface Module ..........................1-1 High Flow Module ..........................1-1 Low Flow Module ..........................1-1 Oxygen Sensor ..........................1-1 List of Standard Components ....................... 1-2 Certifier Plus High Flow Test System, Standard Kit (Model 4080-S) .......... - Page 6 Connect the Oxygen Sensor ......................3-2 Breath Triggers ..........................3-2 Connect the Certifier™ Plus to a Ventilator ..................3-3 Connecting the Low Flow Module ......................3-5 Pre-Test Checks ........................... 3-5 Low Flow Module ..........................3-5 High Flow Module ..........................3-5 Flow Module Self-Check ........................
- Page 7 Cleaning the Flow Analyzer ........................6-2 Factory Calibration (Recommended annually) ..................6-3 Return Procedure ..........................6-3 CHAPTER 7 Specifications .......................... 7-1 Physical ..............................7-1 Environmental ............................7-1 Power ..............................7-1 Compliance ............................7-1 Measurements ............................7-2 APPENDIX A Data Export Formats ......................A-1 Snapshot Data File from the Parameter Screen ...................
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Page 9: Chapter 1 Introduction And Parts Identification
C H A P T E R 1 Introduction and Parts Identification I n t r o d u c t i o n The Certifier™ Plus Gas Flow Analyzer Test System is a portable, multi-functional pneumatic tester designed specifically for the medical industry. Specific measurements for ventilator testing are programmed and include flows, volumes, pressures, oxygen concentration, and breath timing. -
Page 10: List Of Standard Components
L i s t o f S t a n d a r d C o m p o n e n t s 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. -
Page 11: Certifier Plus High Flow Test System, Full Kit (Model 4080-F)
Certifier Plus High Flow Test System, Full Kit (Model 4080-F) Item Replacement Part Number Description Number Qty. 1-10, Certifier Plus High Flow Test System, Standard Kit 14 of 15 Standard Kit components 12-15 Certifier Oxygen Sensor Kit 4073 RAM Mounting Kit for Interface + Flow Module 130399 Adapter, 22 mm F to 22 mm F, Straight 130373... -
Page 12: List Of Accessory Kits
L i s t o f A c c e s s o r y K i t s Certifier Plus Low Flow Module Kit (Model 4082) Item Description Part Number Qty. Low Flow Module 4082 Inlet Filter, HEPA, 3/8 to 1/2-inch barb, plus 1602342 3/8-inch tubing Coupling, 3/8-inch tube... -
Page 13: Mounting Kit, For Certifier™ Plus Interface And Flow Module (Pn 130399)
Mounting Kit, for Certifier™ Plus Interface and Flow Module (PN 130399) Item Description Part Number Quantity RAM Double Socket Arm 130371 RAM Tough-Claw Small Clamp Base with Ball 130372 Adapter Plate for Interface + Flow Module, sheet metal 227099 (Attach either a 4081 high flow or 4082 low flow module) Certifier™... -
Page 14: Other Optional Accessories
O t h e r O p t i o n a l A c c e s s o r i e s Description Part Number Image Deluxe Carrying Case, Certifier™ 130393 Plus, fitted (13.8 x 9.5 x 8.1 in.) Test Lung, Adult, 1.0L, includes 130396 elbow connector... -
Page 15: Chapter 2 Flow Analyzer Overview
C H A P T E R 2 Flow Analyzer Overview I n s t r u m e n t O v e r v i e w 4089 Interface Module, Back 4089 Interface Module, Front Flow Module Connector (A) Screw hole for USB-C cable lock Flow Module Connector (B) Tilt Stand... -
Page 16: 4081 High Flow Module, Back
4081 High Flow Module, Back 4081 High Flow Module, Front Interface Module Connector Mounting holes (threaded #8-32) Low Pressure Ports (± 150 cmH Sensor Input Connect to “+” port for airway pressure TTL Trigger Input High Pressure Port (150 PSIG, 10 bar) 4082 Low Flow Module Interface Module Connector Mounting holes (threaded #6-32) -
Page 17: Operation Overview
O p e r a t i o n O v e r v i e w Flow Modules You can connect or disconnect Certifier™ flow modules from the Certifier™ interface module at any time during normal operation without having to reboot the instrument or change settings. Flow modules can be connected to either of the flow module ports (A or B) on the interface module. -
Page 18: Touchscreen Display
If the Certifier™ Plus test system is turned off with the battery installed while connected to power via the power cable, then the power button will display the following LED states: • Solid yellow: Battery is charging • Blinking yellow: Battery is full, no charging needed If no battery is installed and the Certifier™... -
Page 19: Measurements And Units
M e a s u r e m e n t s a n d U n i t s Available Measurement Parameters The list parameters available for selection is dependent on the model of the connected flow module. Symbol Description Symbol Description... -
Page 20: Measurement Parameter Definitions
Measurement Parameter Definitions Certifier™ Plus Flow Analyzer Test System... -
Page 21: Chapter 3 Flow Analyzer Setup
C H A P T E R 3 Flow Analyzer Setup G e t t i n g S t a r t e d Power On/Off Press the power button on the 4089 Interface Module once to turn the instrument on. Press and hold the power button for 5 seconds to begin the controlled shutdown procedure. -
Page 22: Connect The Low Pressure Measurement
Connect the Low Pressure Measurement Low pressure is available from the 4081 high flow module only. To connect the oxygen sensor kit, attach the airway pressure fitting with screen (1) to the outlet of the flow module. Cut a length of silicon tubing (2), connect one end of the tubing to the barb on the airway pressure fitting, and connect the other end of the tubing to the (+) port of the flow module. -
Page 23: Connect The Certifier™ Plus To A Ventilator
Start and end of the breath can also be triggered by a TTL voltage signal given at the connector on the Certifier™ Plus 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. C o n n e c t t h e C e r t i f i e r ™... - Page 24 7. Connect the low pressure measurement and oxygen sensor (if applicable) to the flow module. Refer to the Instrument Setup section for low pressure and oxygen sensor setup instructions. 8. Configure the Certifier Plus settings from the interface display as desired for the instrument under test.
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Page 25: Connecting The Low Flow Module
NOTICE If using a test lung with a built-in restrictor or a separate restrictor, connect the airway pressure fitting with less than 15 cm length of the 22 mm tubing between the restrictor and the flow module. If this is not done, the flow direction sensor may not work properly. C o n n e c t i n g t h e L o w F l o w M o d u l e The 4082 low flow module is used for testing flow in oxygen concentrators and other low flow devices. -
Page 26: Flow Module Self-Check
Flow Direction Sensor The model 4081 High Flow Module has a sensor that is used to detect the direction of flow. This sensor will normally auto-zero if there is no flow for a fraction of a second. To manually zero the direction sensor, remove the high flow module from the flow source and cover one or both ends of the flow tube for a couple of seconds. -
Page 27: Chapter 4 Touchscreen Operation
C H A P T E R 4 Touchscreen Operation D i s p l a y I n t e r f a c e O v e r v i e w The two primary screens on the Dashboard of the Certifier™ Plus Flow Analyzer are the Parameter Screen and the Graph Screen. -
Page 28: Warnings And Errors
4. Battery Indicator – Displays the current charge remaining between 0 to 100%. A lightning bolt symbol will be shown inside the battery icon if the Certifier™ Plus battery is actively charging. An exclamation point will be shown inside the battery icon if the Certifier™ Plus flow analyzer is powered but no battery is connected. -
Page 29: Graph Screen
Graph Screen 1. Plotted Measurements 4. Trigger Indicators 2. Y-Axis 5. Real-time Measurements 3. X-Axis 6. Edit Graph 1. Plotted Measurements – Displays current values for the selected measurements and their units and plots the measurement on the graph. Press either the measurement symbol, reading, or units to edit elements of the graph screen. -
Page 30: Module Cards
Module Cards A module card is generated at the top of the dashboard for each flow module connected to the Certifier™ interface. Upon pressing a module card, you will be able to view and edit settings related to that particular module. Item Description Serial Number... -
Page 31: 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 32 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). If more than one module is connected, then a letter (ex.
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Page 33: 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 34: 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 35 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.
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Page 36: Averaging
Averaging Access the Averaging screen by pressing on the area around the Breaths and Averaging Time fields or gear icon located at the bottom of the screen. Averaging can also be accessed through the Menu by selecting Settings and then the Triggers and Averaging option. Number of Breaths This setting specifies the maximum number of breaths over which to average the breathing parameter measurements. -
Page 37: Managing Configurations
Note that an asterisk will be displayed in front of the configuration name to indicate that the settings have been changed and differ from what is saved in the original configuration. The asterisk will be removed if the Certifier™ flow analyzer is changed back to the original configuration settings or if the configuration is reloaded. -
Page 38: Loading Configurations
Loading Configurations Locate the configuration in the list under Local Configurations and press the 3-dot icon for the file row. Select the Load option from the pop-up menu. Note that only one configuration can be loaded and active on the Certifier™ flow analyzer at a time, the check boxes are not used for loading configurations. -
Page 39: Exporting Configurations
If you choose to create a new configuration to save the setup, the Certifier™ flow analyzer will generate a new configuration named “New Configuration”. To rename the new configuration, press the 3-dot menu and select the Rename option. Press on the text field in the Edit Configuration pop- up screen to bring up the onscreen keyboard. -
Page 40: Importing Configurations
Importing Configurations The Certifier™ Plus flow analyzer can import configurations from a USB flash drive inserted into either of the 2 USB-A ports located on the top side of the 4089 Interface Module. 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 Export menu option, or check the corresponding box and press the export icon (up arrow). -
Page 41: 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 42: 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 43: Trigger Timing
Trigger Timing 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 44: 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 45: Calibrate Oxygen Sensor
After zeroing, a status is displayed for each connected 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. Note that the barometric pressure sensor (used for absolute pressure measurements) does not require zeroing and;... -
Page 46: Data Logging And Export
D a t a L o g g i n g a n d E x p o r t The Certifier™ Plus 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. - Page 47 Note that after pressing the SAVE button, the Certifier will return to the previous screen with the display still paused. Press the play button (triangle icon) in the right navigation bar to resume updating the display. Pressing the CANCEL button from the Data Save screen will return you to the previous screen and automatically resume updating the display.
- Page 48 Waveform Logging Waveform logging is used to record raw sensor data with high resolution. Waveform logs include data for flow rate, low pressure, high pressure, absolute pressure, temperature, and oxygen concentration (if connected) regardless of the screen from which logging was initiated. The sampling rate for waveform logging is fixed at 1 ms (1000 Hz).
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Page 49: Managing Data
Managing Data Saved screenshots and data log files are stored in the internal memory of the Certifier™ Plus flow analyzer and can be viewed from the Manage Data screen. Access the Manage Data screen by pressing the Menu and selecting the Manage Data menu option. From this screen you can preview, export, or delete screenshots and saved files. - Page 50 Preview Saved Files You can preview screenshots and data logs from the Certifier™ Plus display prior to exporting. To do this, press anywhere on the row of the file you want to view. 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.
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Page 51: Exporting Data
Press on the image in the File Preview screen to increase its size for easier viewing. Press on the image again to return the expanded image to its original size. 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. -
Page 52: Viewing Exported Data
While actively exporting files, a loading icon will appear and the export progress is shown in the bottom screen bar. The Certifier™ flow analyzer will provide notification when the export has completed. Snapshots are exported as .png image files and data is exported as .csv files. The delimiter for data export can be set as comma, pipe, semicolon, or tab delimited. -
Page 53: Device Settings
D e v i c e S e t t i n g s 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™... -
Page 54: Triggers And Averaging
Triggers and Averaging You can navigate to the triggers and averaging settings through the menu screen as an alternative to accessing these settings from the dashboard screens. Refer to the Breath Triggers Averaging sections for detailed instructions. Oxygen Sensor In the Oxygen Sensor screen is where you can field calibrate their connected oxygen sensor(s). Refer to the section Calibrate Oxygen Sensor for oxygen calibration instructions. -
Page 55: Chapter 5 Troubleshooting
C H A P T E R 5 Troubleshooting The table below lists the symptoms, possible causes, and recommended corrective actions for problems that may be encountered while operating the Certifier™ Plus 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 56 Symptom Possible Cause Corrective Action It’s possible the inspiratory I:E ratio or I time readings do Display the I time, T , and not appear correct. pause function is turned on ratio when the inspiratory inside the ventilator. pause is activated on the ventilator.
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Page 57: Chapter 6 Maintenance
C H A P T E R 6 Maintenance R e c h a r g i n g t h e B a t t e r y The fastest charging method is to charge the internal batteries with the Certifier™ Plus Flow Analyzer Test System turned off. -
Page 58: Replacing The Oxygen Sensor
To install a battery into the Certifier™ Plus flow analyzer: • Turn the Certifier™ interface module off and disconnect any cables • Remove the protective cover (if attached) • Plug the battery pigtail connector into the Certifier™ Plus flow analyzer •... -
Page 59: Factory Calibration (Recommended Annually)
• Package the Certifier™ Plus flow analyzer components carefully to avoid damage during shipping. Note that it is not necessary to return the interface module for calibration. TSI Instruments Singapore Pte Ltd TSI Incorporated 150 Kampong Ampat 500 Cardigan Road... - Page 60 (This page intentionally left blank) Certifier™ Plus Flow Analyzer Test System...
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Page 61: Chapter 7 Specifications
C H A P T E R 7 Specifications Note that specifications are subject to change without notice. P h y s i c a l Dimensions ....... Interface Module: 20.5 cm x 10.6 cm x 7.3 cm High Flow Module: 15 cm x 6.7 cm x 6.1 cm Low Flow Module: 12.7 cm x 5.1 cm x 2.8 cm Flow connectors ....... -
Page 62: Measurements
M e a s u r e m e n t s See additional notes listed at the end of the specifications. Measurement High Flow Module (4081) Low Flow Module (4082) V ̇ , V ̇ , V ̇ Flows PEAK Range -200 to +300 SLPM air, oxygen,... - Page 63 Measurement High Flow Module (4081) Low Flow Module (4082) Absolute Pressure Range 375 to 1200 mmHg 375 to 1200 mmHg Accuracy ±8 mmHg ±8 mmHg Oxygen Concentration Range 21 to 100% Not available Accuracy 2% concentration Not available Temperature Range 5 to 40 °C 5 to 40 °C Accuracy...
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Page 65: Appendix A Data Export Formats
A P P E N D I X A Data Export Formats S n a p s h o t D a t a F i l e f r o m t h e P a r a m e t e r S c r e e n Note that Snapshots of the Parameter screen capture a single data point for all selected measurements. -
Page 66: Continuous Log File (Initiated From The Parameter Screen Or Graph Screen
C o n t i n u o u s L o g f i l e ( I n i t i a t e d f r o m t h e P a r a m e t e r S c r e e n o r G r a p h S c r e e n ) Certifier™... -
Page 67: Waveform Log File (Initiated From The Parameter Screen Or Graph Screen
W a v e f o r m L o g f i l e ( I n i t i a t e d f r o m t h e P a r a m e t e r S c r e e n o r G r a p h S c r e e n ) Note that the cells in the “Time”... - Page 68 (This page intentionally left blank) Certifier™ Plus Flow Analyzer Test System...
- Page 70 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 6016477 Rev B ©2022 TSI Incorporated...
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