Related Manuals for TSI Instruments CERTIFIER FA PLUS
Summary of Contents for TSI Instruments CERTIFIER FA PLUS
- Page 1 CERTIFIER FA PLUS ® TEST SYSTEM OPERATOR’S MANUAL P/N 1980560, REVISION L JULY 2018 1.800.561.8187 GlobalTestSupply information@itm.com www. www. .com .com Find Quality Products Online at: sales@GlobalTestSupply.com...
- Page 2 CERTIFIER FA PLUS ® TEST SYSTEM OPERATOR’S MANUAL P/N 1980560, REVISION L JULY 2018 1.800.561.8187 GlobalTestSupply information@itm.com www. www. .com .com Find Quality Products Online at: sales@GlobalTestSupply.com...
- Page 3 Copyright TSI Incorporated / 2010-2018 / All rights reserved. Address TSI Incorporated / 500 Cardigan Road / Shoreview, MN 55126 / USA Fax No. (651) 490-3824 Caution TSI flowmeters are not medical devices under FDA 510(k) and in no situation should be used for human measurements.
- Page 4 If any malfunction is discovered, please contact your nearest sales office or representative, or call TSI's Customer Service department at (800) 680- 1220 / (1) 651 490-2860 (USA and International) or TSI Instruments in UK at: +44 (0) 1494 4 59200. Trademarks Certifier ®...
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Page 5: Table Of Contents
CONTENTS INTRODUCTION ....................... 1 Parts List ......................2 Glossary ......................6 1.2.1 Symbols on Display ................6 SETUP AND OPERATION ..................11 Keypad Functions ..................14 Power up ....................... 15 Display Navigation ..................15 2.3.1 Measurement Selection ..............18 2.3.2 Graph Measurement Selection ............19 2.3.3 Available Measurement Parameters .......... - Page 6 MAINTENANCE ...................... 39 Recharging the Batteries (as required) ............39 Replacing the Oxygen Sensor ..............39 Cleaning (as required) ................... 39 Factory Calibration (recommended yearly) ........... 40 Return Procedure ..................40 SPECIFICATIONS ....................41 Physical ......................41 Environmental ....................41 Power ......................
- Page 7 Figure 16. Example of Graph Screen ................15 Figure 17. Parameter Screen Features ................. 16 Figure 18. Graph Screen Features ................17 Figure 19. Measurement Selection Screen ..............18 Figure 20. Graph Measurement Selection Screen ............19 Figure 21. Parameter Definitions ................... 21 Figure 22.
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Page 8: Introduction
1 Introduction The Certifier ® Flow Analyzer (FA) Test System is a 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. The Certifier ®... -
Page 9: Parts List
The Certifier FA Plus is not a medical device under the Medical Device Directive or FDA 510(k) and in no situation should be used for human measurements. - Page 10 Table 1. Certifier ® FA Test System Parts List Item Replacement Description Quantity Part Number High Flow Standard Kit (part number 4080) Interface Module 4088 High Flow Module 4081 1602341 Bacteria filter, 22-mm 22-mm male/female, for use with High Flow Module 1102091 Adapter, 22-mm ...
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Page 11: Figure 2. Certifier ® Fa Test System Low Flow Module Kit (4082)
Figure 2. Certifier ® FA Test System Low Flow Module Kit (4082) Item Replacement Description Quantity Part Number Low Flow Module Kit (optional—part number 4082) Low Flow Module 4082 Bacteria filter, for use with Low Flow Module 1602342 Mounting bracket (includes bracket, screws, and 1040044 Velcro strap) Coupling,... -
Page 12: Figure 4. Certifier ® Fa Test System Extra Battery And Charger Kit (1208061)
Item Replacement Description Quantity Part Number Oxygen sensor kit (optional—part number 4073) Oxygen sensor 2917019 Threaded tee 1313118 Oxygen sensor cable 1303741 Figure 4. Certifier ® FA Test System Extra Battery and Charger Kit (1208061) Item Replacement Description Quantity Part Number Extra Battery and Charger Kit (optional kit –... -
Page 13: Glossary
1.2 Glossary These labels, terms, and symbols appear on the Certifier FA Test System: ® Refer to manual: see Certifier ® FA Test System Operator’s Manual for important information. CE marking of European Conformity for the Low Voltage Directive (LVD) and the Directive for Electromagnetic Compatibility (EMCD). -
Page 14: Figure 5. Interface Module
Stylus Key Pad Touch Screen Display Figure 5. Interface Module 1: Introduction 1.800.561.8187 GlobalTestSupply information@itm.com www. www. .com .com Find Quality Products Online at: sales@GlobalTestSupply.com... -
Page 15: Figure 6. Back Of Interface Module
Module B Connector Module A Connector (not used) USB Connector SD Card Slot Wrist Strap Battery Cover Power Flip Out Stand Input Figure 6. Back of Interface Module Certifier ® FA Plus Test System 1.800.561.8187 GlobalTestSupply information@itm.com www. www. .com .com Find Quality Products Online at: sales@GlobalTestSupply.com... -
Page 16: Figure 7. High Flow Module (Arrow On Module Indicates Positive Flow Direction)
Low Pressure (150 cmH differential) High Pressure Use “+” port for airway Coiled Cable Connector (150 PSIG, 10 bar) pressure. Oxygen Sensor TTL Trigger Input Connector Figure 7. High Flow Module (arrow on module indicates positive flow direction) Coiled Cable Connector Figure 8. -
Page 17: Setup And Operation
2 Setup and Operation Follow these steps to set up the Certifier FA Test System: ® Caution To avoid damage to the Certifier ® FA Test System components, always use bacteria filters upstream of the flow modules, and always cap flow module ports when not in use. -
Page 18: Figure 11. Installing A Flow Module Into The Circuit For Measuring Bi-Directional Flow (Flow Direction Arrow Should Be Towards Test Lung)
4. Install the flow module into the test circuit. Align the flow direction arrow on the flow module with the positive direction of flow through the circuit; for ventilator testing the arrow should point towards the test lung or away from the “To Patient” port on the ventilator. -
Page 19: Figure 12. Test Circuit For Bi-Directional Flow
Figure 12. Test Circuit for Bi-Directional Flow N o t e If using a test lung with a built in restrictor or a separate restrictor, place the airway pressure fitting at least 15 cm of the 22 mm tubing between the restrictor and the flow module. -
Page 20: Keypad Functions
The low flow module is used for testing oxygen concentrators and other low flow devices. It is not designed for testing ventilators. The low flow module includes a push-to-fit tube fitting. To install, push tubes into coupling. To remove fittings, press or pry ring towards the coupling body with a small screwdriver while pulling... -
Page 21: Power Up
2.2 Power up If the device under test is running and creating flow or pressure, temporarily remove the flow module from the test circuit during power up. This allows the flow direction sensor on the high flow module to auto calibrate. Press the I/O (on/off) key on the Interface Module to power up the Certifier ®... -
Page 22: Figure 17. Parameter Screen Features
By touching on the active areas of the Parameter Screen, you can change the configuration of the display by choosing which parameters to monitor, units of measure, gas calibration, gas conditions, averaging, and triggering. You can also save the display configuration to a file or load a previously saved configuration. Stops/Starts data acquisition Figure 17. -
Page 23: Figure 18. Graph Screen Features
By touching on the active areas of the Graph Screen, you can change the configuration of the display by choosing which parameters to plot on the Graph, units of measure, gas calibration, gas conditions, averaging, triggering, x and y axis scale. -
Page 24: Measurement Selection
2.3.1 Measurement Selection To add a parameter to the Parameter Screen, touch the parameter and then touch the right direction arrow. The available parameters change depending on what module is attached. To remove a parameter from the Parameter Screen, touch the parameter and then touch the left direction arrow. -
Page 25: Graph Measurement Selection
2.3.2 Graph Measurement Selection To add a parameter to Graph, touch the parameter on the left and then touch the top right direction arrow. Only two parameters can be graphed at one time. The available parameters change depending on what module is attached. ... -
Page 26: Available Measurement Parameters
2.3.3 Available Measurement Parameters Table 3. Parameters (parameter list changes depending on module attached) Flow Rate. “Q” is used on the High pressure transducer Graph Screen. (4081 only) Peak Flow Rate—Peak Inhaled Absolute pressure in flow tube. Flow Rate. “Qpeak” is used on If flow tube open to the Graph Screen. -
Page 27: Figure 21. Parameter Definitions
Figure 21. Parameter Definitions 2: Setup and Operation 1.800.561.8187 GlobalTestSupply information@itm.com www. www. .com .com Find Quality Products Online at: sales@GlobalTestSupply.com... -
Page 28: Gas Conditions Selection Box
2.3.4 Gas Conditions Selection Box Figure 22. Gas Conditions Selection Box Standard Temperature and Pressure. The gas flow rate and volumes are displayed in terms of what the gas flow rate and volume would be if the gas was 21°C and 1 atmosphere (101.3 kPa) of pressure. Actual Temperature and Pressure. -
Page 29: Averaging Setup Menu
2.3.5 Averaging Setup Menu Figure 23. Averaging Setup Menu Number of All breath parameters are averaged over the selected number of Breaths breaths. Averaged Second All displayed transducer measurements are averaged over the Average for selected number of seconds. Transducer measurements include: Real-Time flow, low pressure, high pressure, absolute pressure, oxygen Values... -
Page 30: Breath Trigger Types
2.3.6 Breath Trigger Types This screen defines how the start of the inspiratory breath cycle and the expiratory breath cycle are detected. Under most circumstances, it is recommended that the auto- trigger be used. Figure 24. Trigger Options Menu Flow Rate Start and end of the breath is determined by the specified flow rate. -
Page 31: Flow Triggering
There are two suggested methods for determining the appropriate start and end trigger values: 1) switch the Certifier FA Plus Test System to the graphing screen and observe the flow or pressure readings at the start and the end of inspiration and 2) observe the flow and pressure wave form from the ventilator being tested. -
Page 32: Saving/Loading Configurations
2.3.8 Saving/Loading Configurations Configuration is saved under current name and location Figure 25. Configuration Save Screen Configuration of the values displayed, gas, conditions, triggering, and graph setup can be saved and recalled. This allows the user to save configurations for different equipment. -
Page 33: Print/Save Button
2.3.9 Print/Save Button If the Print/Save button is pressed while viewing the Parameter Screen, the "Print/Save Options" screen will appear. By selecting the various options on this screen you will be able to: Print the current data record without saving to a file. ... -
Page 34: Waveform Logging
To retrieve data from the Certifier test system, simply connect the device to a PC using an USB standard A to mini-B cable. Use the Setup function “Select Mass Storage Target” (see section 2.3.10 “Setup Key”) to choose whether the host PC will access the Certifier test system’s built-in memory, or an SD Flash card inserted in the card slot of the Certifier test system. -
Page 35: Setup Key
To initiate Continuous logging: Press the Print/Save button on the Certifier test system keypad. Select Continuous from the Logging Features section. You may choose to Add Comments if you would like to annotate the data. Click OK, add comments (if selected) and name the file. ... -
Page 36: Advanced Features
Lock Disables the saving of configurations. The user will be able to load Configuration existing configurations and change the current configuration, but not save it. Advanced Section 2.3.10.1 for a complete list of advanced features which Features can be accessed through this menu. About Device Displays information about the Certifier Interface Module and any connected flow module. -
Page 37: Format Settings
This feature requires an SD card to be inserted in the instrument. If it is desired to view the configuration file on a PC, be sure the Select Mass Storage Device setting is configured to SD card as mentioned in section 2.3.10. Press Export button to export the configuration file to the SD card. -
Page 38: Required Pre-Test Calibrations
Caution To ensure accurate measurements, wait one minute for the Certifier FA Test ® System to warm up. If environmental conditions have changed significantly, more time may be necessary. To avoid damage to the Certifier ® FA Test System components, always use ... -
Page 39: Oxygen Sensor Calibration
2.4.2.3 Oxygen Sensor Calibration Follow these steps daily and following an altitude change or sensor replacement to calibrate the oxygen sensor: 1. Power up the Certifier ® FA Test System with the High Flow Module and oxygen sensor attached, allow one minute to warm up. 2. -
Page 40: Troubleshooting
3 Troubleshooting Table 4 lists the symptoms, possible causes, and recommended corrective actions for problems you may encounter with the Certifier FA Test System. If the symptom is not ® listed, or if none of the recommended corrective actions solve the problem, Table 4. - Page 41 Symptom Possible Cause Corrective Action Volume, minute Less than two Wait for at least two consecutive volume, peak flow, consecutive full breaths full breaths to be supplied to the peak pressure, PEEP, have been supplied to flow module. respiratory rate, or I:E flow module, or flow is not ratio measurements supplied as a breathing...
- Page 42 Symptom Possible Cause Corrective Action Oxygen sensor 21% oxygen and/or 100% Verify that calibration gases are calibration fails. oxygen not supplied for 21% oxygen and 100% oxygen calibration. and repeat calibration. Oxygen sensor is Replace oxygen sensor. expired. Non-steady flow or tidal Use constant flow rates to flows used.
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Page 43: Maintenance
The fastest charging method is to charge the battery in the instrument with the instrument turned off. The Certifier FA Plus uses SBL-160, Lithium Ion Batteries, which are available from many battery supply houses or TSI. -
Page 44: Factory Calibration (Recommended Yearly)
4.4 Factory Calibration (recommended yearly) Certifier ® FA Test System flow modules are designed for one year of normal use following each factory calibration. If the test system has been dropped or liquid has penetrated any of its components, do not use, and return to the factory for calibration. Recalibrated flow modules come with a certificate of calibration and a summary of performance before and after the calibration. -
Page 45: Specifications
5 Specifications NOTE: Specifications are subject to change without notice. 5.1 Physical Dimensions Interface module: 17.3 cm 10.5 cm 4.5 cm (6.8 in. 4.1 in. 1.8 in.) High Flow Module: 15 cm 6.7 cm 6.1 cm (5.9 in. 2.7 in. 1.4 in.). Low Flow Module: 12.7 cm ... -
Page 46: Data Transfer And Storage
5.4 Data Transfer and Storage Internal Memory 1 MB (500 typical records) External Memory SD Flash Card. Supports up to 1 GB cards. 5.5 Test Measurements See notes at end of section. See Table 3 for symbol definitions.) Measurement High Flow Module Low Flow Module Flows Range... - Page 47 Measurement High Flow Module Low Flow Module Volumes Range 0.01 to 10 L STP Not applicable Accuracy Not applicable Air and oxygen: 3% of reading plus 0.030 L Air/oxygen mixtures: 4% of reading plus 0.040 L STP Minute Volume Range 0.01 to 100 L STP 0 to 10 L STP Accuracy...
- Page 48 Measurement High Flow Module Low Flow Module High Pressure Range -10 to 150.0PSIG Not applicable (-0.7 to 10 bar) Accuracy 1% of reading or 0.1 PSI Not applicable (7 mbar), whichever is greater. Absolute Pressure Range 375 to 1200 mmHg 375 to 1500 mmHg (500 to 1600 mbar) (500 to 2000 mbar)
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Page 49: Calibration Recommendations
Measurement High Flow Module Low Flow Module NOTES 1. Standard conditions are defined as 21.1C (70F) and 101.3 kPa (14.7 psia). 2. Flow and volume accuracy is applicable at these standard conditions (see note 1). 3. For the High Flow Module the temperature of the gas and the ambient air must be within 10C (18F) of each other and the gas must be less than 30% relative humidity at 21.1C (70F). -
Page 50: Appendix A Data File Formats
Appendix A Data File Formats Parameter Screen Single Sample and Continuous Logging Data Format Raw Text Example: Filename:,\NV1FLASH\EXAMPLE.csv Comments:,Custom comments here Configuration:,*Current Configuration Module A Model:,4081 Module A SN:,40810705010 Trigger Type:,Flow Rate Start Trigger:,Auto End Trigger:,Auto Module A Conditions:,STP Module A Gas:,AIR Data Section:,,Module A,Module A,Module A ,,Flow Rate,Low Pressure,PEEP Pressure Date,Time,L/Min,cmH2O,cmH2O... - Page 51 As Formatted By spreadsheet application: Filename: \NV1FLASH\EXAMPLE.csv Comments: Custom comments here Configuration: *Current Configuration Module A 4081 Model: Module A SN: 40810705010 Trigger Type: Flow Rate Start Trigger: Auto End Trigger: Auto Module A Conditions: Module A Gas: Data Section: Module A Module A Module A...
- Page 52 Raw Text Example (waveform logging): Appendix A Data File Formats 1.800.561.8187 GlobalTestSupply information@itm.com www. www. .com .com Find Quality Products Online at: sales@GlobalTestSupply.com...
- Page 53 Graph Screen Data Format The Graph Display data is formatted as 2 (1 parameter on Graph) or 3 (2 parameters on Graph) columns of text. The first column is the X axis (relative time), the second and third columns will contain the Graph data. Q L/Min P cmH2O Total graph time: 10 seconds.
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