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TSI Incorporated Certifier FA Plus, Руководство оператора

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ii 

Certifier

®

 FA Plus Test System 

CASE OF SOFTWARE, SELLER WILL REPAIR OR REPLACE DEFECTIVE SOFTWARE OR IF UNABLE TO 
DO SO, WILL REFUND THE PURCHASE PRICE OF THE SOFTWARE. IN NO EVENT SHALL SELLER BE 
LIABLE FOR LOST PROFITS, BUSINESS INTERRUPTION, OR ANY SPECIAL, INDIRECT, 
CONSEQUENTIAL OR INCIDENTAL DAMAGES. SELLER SHALL NOT BE RESPONSIBLE FOR 
INSTALLATION, DISMANTLING OR REINSTALLATION COSTS OR CHARGES. No Action, regardless of 
form, may be brought against Seller more than 12 months after a cause of action has accrued. The goods 
returned under warranty to Seller's factory shall be at Buyer's risk of loss, and will be returned, if at all, at 
Seller's risk of loss. 

Buyer and all users are deemed to have accepted this LIMITATION OF WARRANTY AND LIABILITY, which 
contains the complete and exclusive limited warranty of Seller. This LIMITATION OF WARRANTY AND 
LIABILITY may not be amended, modified or its terms waived, except by writing signed by an Officer of Seller. 

Service Policy 

Knowing that inoperative or defective instruments are as detrimental to TSI as they are to our customers, our 
service policy is designed to give prompt attention to any problems. If any malfunction is discovered, please 
contact your nearest sales office or representative, or call TSI's Customer Service department at (800) 874-
2811 / (1) 651 490-2811 (USA and International) or TSI Instruments in UK at: +44 (0) 1494 4 59200. 

Trademarks 

Certifier

®

 is a registered trademark of TSI Incorporated. 

Содержание Certifier FA Plus

Страница 1: ...CERTIFIER FA PLUS TEST SYSTEM OPERATOR S MANUAL P N 1980560 REVISION J FEBRUARY 2016...

Страница 2: ......

Страница 3: ...ERATOR S MANUAL P N 1980560 REVISION J FEBRUARY 2016 U S INTERNATIONAL TSI Instruments Ltd UK Sales and Customer Service Sales and Customer Service 800 874 2811 1 651 490 2811 44 0 1494 459200 Fax Fax...

Страница 4: ......

Страница 5: ...calibrated at the time of its manufacture Instruments returned for calibration are not covered by this warranty f This warranty is VOID if the instrument is opened by anyone other than a factory autho...

Страница 6: ...at all at Seller s risk of loss Buyer and all users are deemed to have accepted this LIMITATION OF WARRANTY AND LIABILITY which contains the complete and exclusive limited warranty of Seller This LIM...

Страница 7: ...th Trigger Types 26 2 3 7 Flow Triggering 27 2 3 8 Saving Loading Configurations 28 2 3 9 Print Save Button 29 2 3 9 1 Waveform Logging 30 2 3 9 2 Continuous Logging 31 2 3 10 Setup Key 32 2 3 10 1 Ad...

Страница 8: ...ow Standard Kit 4080 2 Figure 2 Certifier FA Test System Low Flow Module Kit 4082 4 Figure 3 Certifier FA Test System Oxygen Sensor Kit 4073 4 Figure 4 Certifier FA Test System Extra Battery and Charg...

Страница 9: ...Setup Menu 25 Figure 24 Trigger Options Menu 26 Figure 25 Configuration Save Screen 28 Figure 26 Print Save Options Screen 29 Figure 27 Add Comments Screen 30 Figure 28 Setup Menu 32 Figure 29 Advance...

Страница 10: ...vi Certifier FA Plus Test System This page intentionally left blank...

Страница 11: ...to 40 standard L min for CO2 A 150 PSI 10 Bar gauge transducer a barometric pressure transducer and a 150 cm H2O differential pressure transducer are also in the High Flow Module Low Flow Module Meas...

Страница 12: ...ot a medical device under the Medical Device Directive or FDA 510 k and in no situation should be used for human measurements 1 1 Parts List Carefully unpack the test system components from the shippi...

Страница 13: ...rap for use on High Flow Module 2913133 1 9 Adapter high pressure port 1611221 1 10 Cable flow module 1040219 1 11 4 Soft carrying case 1319289 1 12 Power supply 90 260 VAC to 12 VDC 2613237 1 13 Styl...

Страница 14: ...le Kit optional part number 4082 20 Low Flow Module 4082 1 21 Bacteria filter for use with Low Flow Module 1602342 1 22 Mounting bracket includes bracket screws and Velcro strap 1040044 1 23 Coupling...

Страница 15: ...xygen sensor cable 1303741 1 Figure 4 Certifier FA Test System Extra Battery and Charger Kit 1208061 Item No Description Replacement Part Number Quantity Extra Battery and Charger Kit optional kit par...

Страница 16: ...t detecting a significant amount of negative flows When testing ventilators unidirectional flow is used when the flow module is connected to the To Patient line Flow module is in bi directional flow m...

Страница 17: ...1 Introduction 7 Figure 5 Interface Module Touch Screen Display Key Pad Stylus...

Страница 18: ...Certifier FA Plus Test System 8 Figure 6 Back of Interface Module Module B Connector not used Module A Connector USB Connector SD Card Slot DC Power Input Flip Out Stand Battery Cover Wrist Strap...

Страница 19: ...n module indicates positive flow direction Figure 8 Low Flow Module High Pressure 150 PSIG 10 bar Low Pressure 150 cmH2O differential Use port for airway pressure Coiled Cable Connector TTL Trigger In...

Страница 20: ...Certifier FA Plus Test System 10 Figure 9 Oxygen Sensor Kit...

Страница 21: ...y charge the battery overnight before using with battery alone 2 Install SD flash memory card into card slot on top of the interface module This step is necessary only if planning to log data 3 Connec...

Страница 22: ...low 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 Figure 11 Inst...

Страница 23: ...l Flow Note 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 If...

Страница 24: ...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 cou...

Страница 25: ...On OFF key Zeroing Key Press this key to zero the high and low pressure transducers Print Save Key Press this key to print and or save data See Print Save section pg 29 in this manual for more informa...

Страница 26: ...stem components At power up the Interface Module shows information in this sequence below After this return the flow module into the test circuit 1 Logo screen appears on display for several seconds 2...

Страница 27: ...2 Setup and Operation 17 2 3 Display Navigation The main two screens are the Parameter Screen and the Graph Screen Figure 15 Example of Parameter Screen Figure 16 Example of Graph Screen...

Страница 28: ...he 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 o...

Страница 29: ...by choosing which parameters to plot on the Graph units of measure gas calibration gas conditions averaging triggering x and y axis scale You can also save the display configuration to a file or load...

Страница 30: ...then touch the left direction arrow To move a parameter higher on the Parameter Screen touch the parameter and then use the up and down direction arrows To change the gas calibration used touch the g...

Страница 31: ...op left direction arrow To change the gas calibration used touch the gas dropdown list and select the desired gas To add a parameter to the label section below the graph touch the parameter and then t...

Страница 32: ...s used on the Graph Screen Oxygen concentration with both 4081 and 4073 only Inhaled tidal volume Temperature of gas accurate for flows above 5 L min Exhaled tidal volume 4081 only Frequency Breath ra...

Страница 33: ...2 Setup and Operation 23 Figure 21 Parameter Definitions I E t E t I I E IP t E t I P f 1 t I P t E MV V TI f...

Страница 34: ...emperature and Pressure Saturated The gas flow rate and volumes are displayed in terms of what the gas flow rate and volume would be if the gas was changed to 37 C the actual pressure and also saturat...

Страница 35: ...ll breath parameters are averaged over the selected number of breaths Second Average for Real Time Values All displayed transducer measurements are averaged over the selected number of seconds Transdu...

Страница 36: ...Pressure Start and end of the breath is determined by the specified pressure levels Positive slope changed through the first value is used for the start of inspiratory and a negative slope through th...

Страница 37: ...veform of interest 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 o...

Страница 38: ...lues displayed gas conditions triggering and graph setup can be saved and recalled This allows the user to save configurations for different equipment See section 2 3 10 1 to learn how to transfer con...

Страница 39: ...current data record to a file without printing Select Waveform logging function This feature saves 15 seconds of raw flowmeter data at a rate of 1 millisecond reading to a file requires an SD Flash me...

Страница 40: ...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 All data files exported from Certifier test system use the ASCII c...

Страница 41: ...ter Screen will be logged See section 2 3 on how to add or remove parameters The data is exported into comma separated value CSV format readable by many common spreadsheet and database applications Se...

Страница 42: ...k Touch Screen Disables the touch screen once the Setup Menu is closed To enable the touch screen press the Setup button Lock Configuration Disables the saving of configurations The user will be able...

Страница 43: ...gure 29 Advanced Function Menu 2 3 10 1 1 Configuration Import Export This feature enables you to both download and upload configuration files to and from the SD card This is convenient when multiple...

Страница 44: ...n Importing a configuration file will not erase existing configuration files which already exist in memory but under a different configuration name This feature is not designed for creating configurat...

Страница 45: ...unable to do this at power up or at least every 10 minutes a appears on the screen Touch the symbol on the display for an explanation of the warning To manually zero the direction sensor remove the H...

Страница 46: ...ration box on the display Follow the directions on the screen Note that either an air only or an air and 100 oxygen calibration can be done The two point air 100 oxygen calibrations provide the best a...

Страница 47: ...ugh Interface Module is turned on Flow module is not connected to Interface Module Connect flow module to Interface Module If connected disconnect and then reconnect Measurements are not changing or g...

Страница 48: ...the screen between the flow module and the test lung see Figure 12 Minimize length of tubing between the test lung and the airway pressure fitting I E ratio or I time readings do not appear correct It...

Страница 49: ...epeat calibration Replace oxygen sensor Use constant flow rates to supply calibration gas Pressure trigger gives erroneous results Pressure signal supplied to high flow module not correct Change sourc...

Страница 50: ...40 Certifier FA Plus Test System This page intentionally left blank...

Страница 51: ...ns before the expiration date Replace the oxygen sensor every year or two of normal use or if the sensor cannot be calibrated or sensor readings are erratic 4 3 Cleaning as required Table 5 summarizes...

Страница 52: ...ule for factory calibration Follow the steps in Section 4 5 to return Certifier FA Test System flow modules for factory calibration 4 5 Return Procedure Follow these steps to return Certifier FA Test...

Страница 53: ...low outlet 3 8 in Weight Approximately 0 7 kg 1 5 lb interface with high flow module and cable 5 2 Environmental Temperature Operating 5 to 40 C 41 to 104 F 15 to 80 relative humidity from 5 to 31 C d...

Страница 54: ...g or 0 075 standard L min whichever is greater Nitrogen and carbon dioxide 3 of reading or 0 075 standard L min whichever is greater Air Oxygen mixture 4 of reading or 0 100 standard L min whichever i...

Страница 55: ...conds Accuracy 2 of reading or 0 01 seconds whichever is greater 2 of reading or 0 01 seconds whichever is greater I E Ratios Range 1 100 0 to 100 0 1 1 100 0 to 100 0 1 Accuracy 4 of reading typical...

Страница 56: ...whichever is greater Not applicable Absolute Pressure Range 375 to 1200 mmHg 500 to 1600 mbar 375 to 1500 mmHg 500 to 2000 mbar Accuracy 8 mmHg 11 m bar 8 mmHg 11 mbar Oxygen Concentration Range 21 to...

Страница 57: ...f reading per 1 03 kPa 0 15 psia above 101 3 kPa 14 7 psia 0 022 of reading per 1 03 kPa 0 15 psia below 101 3 kPa 14 7 psia 0 07 of reading per 1 relative humidity above 30 relative humidity The Low...

Страница 58: ...48 Certifier FA Plus Test System This page intentionally left blank...

Страница 59: ...ments 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 G...

Страница 60: ...Module A Module A Flow Rate Low Pressure PEEP Pressure Date Time L Min cmH2O cmH2O 27 12 2007 12 03 20 19 2 0 256 0 Notes When Continuous logging is used each additional reading is given on a separat...

Страница 61: ...218 99 489 0 315 43928 11 034 22 808 24 207 99 463 0 338 44159 10 987 22 876 24 223 99 409 0 242 44181 10 973 22 769 24 223 99 463 0 397 43925 10 969 22 708 24 218 99 46 0 461 44098 11 058 22 726 24 2...

Страница 62: ...al graph time 10 seconds 0 0 421556 0 673527 0 041 0 197457 0 678888 0 082 0 095008 0 693449 0 123 0 043302 0 699908 0 1639 0 027286 0 712823 0 2049 0 027088 0 723274 0 2459 0 022927 0 730932 0 2869 0...

Страница 63: ...ation USA Tel 1 800 874 2811 UK Tel 44 149 4 459200 France Tel 33 1 41 19 21 99 Germany Tel 49 241 523030 India Tel 91 80 67877200 China Tel 86 10 8219 7688 Singapore Tel 65 6595 6388 P N 1980560 Rev...

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