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MN-040f Infutest 2000 Operators Manual

1. Re e e cat eR 32 45 Running a Test 26 xti ue Oh ee ae SERES EU EIS 33 4 6 Viewing the Test Summary used nxGo kd p TARTE RS 36 4 6 1 SUMMARY Screen for Single Rate 5 36 4 6 2 SUMMARY Screen for Dual Rate 37 4 6 3 SUMMARY Screen for PCA Pump Test 37 Table of Contents Page v INFUTEST 2000 OPERATING MANUAL 4 6 4 SUMMARY Screen for Occlusion Pressure Test 38 4 6 5 SUMMARY Screen Usage 39 47 Viewing the Data Log BERR EEG EER GES EG 40 4 7 1 Data Log Description eee LR wee EN oe BE OIE RR 40 4 7 2 DATA Screen Usage esos see oer deena eked essa ws 40 4 8 Output of Summary and Data 095 43 ZB A SFIIS acusa ted Too chosen a RUE Ue ate ea th AULUS Qa oe au 47 4 9 1 Nonrecoverable Alarms 47 4 9 2 Recoverable Alarms eor E RE UE RE OMEN 47 4 10 AUIOSCGUCNCES cin Ree a aa sus EYES DERE aie p Dee 49 5 TEST USAGE GUIDELINES RN ESE ESE 53 5 1 General Bulbs pde la accep Moos eg Po ce ope Mad 53 5d ccc yes eee ook eee ae eee eg eU 53 5 1 2 Pump IV Sets and Syringes esee RUE a 55 5 1 9 2 OI BAI co
2. 15 INFUTEST 2000E OPERATING MANUAL IMPORTANT IV sets which have or may have come in contact with saline or dextrose or other IV fluids should not be used on the Infutest If an administration set must re used i e as part of an incident investigation ensure the set has been flushed out thoroughly with clean water before connecting the set to the Infutest Most IV fluids contain salts and sugars which can degrade and potentially ruin the high precision flow sensors inside the Infutest It is always best to use a new administration set when testing a pump However the same administration set may be re used to test several pumps provided the set is primed only with distilled or sterile water Change IV set per the manufacturer s recommendations to ensure that test results reflect clinical use of the infusion device Overview Chapter 2 Page 16 INFUTEST 2000 OPERATING MANUAL Set up Chapter E 4 q This chapter describes the initial set up of the Infutest describes the basic fluid connections fluid priming and serial and parallel output connections 3 INITIAL SET UP 3 1 Connections a Place the instrument on a stable horizontally level surface Connect electrical power to the unit by inserting the power cable into the rear panel receptacle Figure 3 and connecting the cable to a grounded outlet Connect the input tubing set consisting of the IEC recomm
3. Elapsed Flow Avg Flow Volume B Pres Time ml h ml h anl mmHg PRINT 5 TO 25 1 RTA1 Send START command to Infutest Chan A SR Test 1 IFTdata Get Infutest s response DATA LOGGING LOOP V lt VUVVVA Delay 1 second Tzero TIMER DO WHILE TIMER Tzero lt 1 LOOP SLEEP 1 SLEEP 60 or 300 will pause for 60 or 300 seconds and reduce the number of data points saved but not ALL instantaneous points will be collected Get real time data from Infutest chan A PRINT 1 GRA INPUT 1 DataType If data is not x NO DATA READY echo data to screen and save in file IF DataType lt gt x THEN INPUT 1 Hr Min Sec Flow Avg Vol BPr PRINT Hr Min Sec PRINT Flow s AVvg Vol BPr PRINT 2 S CHr i Min See UO s PRINT 2 Flow Avg Vol gt BPr END IF C INKEY Loop until user hits ESCape key LOOP UNTIL C CHR 27 PRINT 1 STA Send STOP command to Infutest INPUT 1 IFTdata Get Infutest s response END IF PRINT 2 END OF DATA Close the data log file and turn off COM port CLOSE END Remote ControllChapter 6 98 INFUTEST 2000 OPERATING MANUAL 6 7 2 medTester Programming The Infutest is fully compatible with the DNI Nevada medTester 5000B and the Fluke Biomedical medTester 5000C Using the medTester you may control the Infutest
4. DATREND Systems Inc Infutest 2000 Sees E Dual Channel Infusion Pump Analyzer Operating Manual Infutest 2000 Series E Dual Channel Infusion Pump Analyzer Operating Manual 2005 2014 Datrend Systems Inc Unit 130 4020 Viking Way Richmond CANADA V6V 2L4 Tel 604 291 7747 or 800 667 6557 Fax 604 294 2355 e mail customerservice datrend com pOATREND Systems Inc To order this manual use Part Number 6100 109 Revision History Revision Description Date E Corporate Address Update 2011 Jul 21 F Update Power Requirements 2014 Nov 04 Copyright Datrend Systems Inc DSI agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications If you would like other reproductions or distributions submit a written request to Datrend Systems Inc Unpacking and Inspection Follow standard receiving practices upon receipt of the instrument Check the shipping carton for damage If damage is found stop unpacking the instrument Notify the freight carrier and ask for an agent to be present while the instrument is unpacked There are no special unpacking instructions but be careful not to damage the instrument when unpacking it Inspect the instrument for physical damage such as bent or broken parts dents or scratches Claims Our routine method of shipment is via common carrier Upon delivery if physic
5. Turn off COM port CLOSE END CommTimeOut Error interrupt handler If no response from Infutest after 1 second display timeout error PRINT TIMEOUT RESUME ReadKey Remote ControllChapter 6 Page 92 INFUTEST 2000 OPERATING MANUAL Example 2 Single Rate With Occlusion Test SROP_TST BAS Single Rate Plus Occlusion Pressure Test c Datrend Systems Inc 2005 This OBasic program illustrates how to use the Infutest Remote Control commands to run a Single Rate Test followed by an Occlusion Pressure Test After you input how long you want each test to run the program starts the Single Rate Test waits until the user input time has elapsed and then stops the test The program then gets and displays the Single Rate test summary An Occlusion Pressure Test is then started After this test is stopped the program gets and displays the peak pressure measured during the test When both test results have been displayed the program produces a bee bop from the speaker to remind the tech that coffee is over If you want to bypass either the Single Rate or Occlusion Pressure Tests enter zero 0 for the test duration when prompted If during either the Single Rate or Occlusion Pressure Test you want to skip the time remaining in the test press the lt ESC gt key DECLARE SUB Delay seconds Main Initialize COM1 for communication with Infutest OPEN COM1 96 0 N 8 1 CDQ C
6. ENTER SET SET SELECT Figure 13 Rate editing keys Operation Chapter 4 Page 29 INFUTEST 2000 OPERATING MANUAL Press SELECT to move the editing cursor to each digit of the displayed rate Press SET to increment the highlighted digit or SET to decrement the highlighted digit Press ENTER to input the displayed SET RATE Infutest will accept rate values ranging from 1 ml h to 1200 ml h Percentage error calculation can be enabled on each Infutest channel independently and each channel can have a different SET RATE value Percentage error calculation applies only to the Single Rate Test or to any AutoSequence test which incorporates a Single Rate Test as part of the test sequence The rate error calculation is not performed for Dual Rate PCA Pump or Occlusion Pressure Tests even if RATE ERROR on the menu of Figure 12 is set to Enable With the calculation enabled the percent error will be shown to the right of the Average Rate measurement which is displayed on the SUMMARY screen for the Single Rate Test refer to Section 4 6 1 In this case the Set Rate value from the menu of Figure 12 will also be incorporated into the Test Summary Report that may be printed or downloaded from Infutest refer to Section 4 8 Operation Chapter 4 Page 30 INFUTEST 2000E OPERATING MANUAL 4 3 Test Measurement Concepts The Series E Infutest introduces a number of new concepts to improve measurement accuracy and allow Infutest
7. XI Weight 10 lbs 4 5 ke IntroductionIlChapter 1 7 INFUTEST 2000 OPERATING MANUAL 1 7 Accessories I Standard Accessories AC line cord Country Voltage specific Universal Voltage Power Supply P N 3000 472 I O tubing set comprising two IEC recommended 21 gauge flow restrictors two three way stop cocks and two Luer lock to Delrin twistlock extension sets P N 7300 005 Flushing syringe 60cc Universal Product USB Drive including Infutest 2000 Operating Manual in Adobe PDF format and Data Transfer and Graphing Program DTP for Windows P N 6950 021 RS 232 Serial Port cable DB25F DB9F P N 3140 040 II Optional Accessories For a complete list of available accessories visit www datrend com or contact Datrend Customer Service see Appendix C for contact details IEC 601 2 24 Part 2 Particular requirements for safety of infusion pumps and controllers IntroductionIlChapter 1 8 INFUTEST 2000E OPERATING MANUAL Chapter Overview This chapter gives an overview of the capabilities of the Infutest the tests performed and test fluid recommendations 2 OVERVIEW OF INSTRUMENT 2 1 General Description The Infutest is an automated self contained system for performing flow rate effused volume and occlusion pressure tests on medical infusion devices In addition to the Single Rate test Infutest is also capable of automatically checking Patient Controlled
8. Analgesia PCA pumps for correct lockout operation and for testing pumps capable of delivering dual rates two preset volumes at differing flow rates i e primary secondary delivery or delivery piggybacking The Infutest has two independently functioning channels designated A and B for simultaneously performing any of four basic selectable test procedures on up to two infusion devices Tests performed simultaneously may be different for each infusion device being evaluated For example a Single Rate Test may be performed on a syringe pump connected to Channel A while a PCA pump is undergoing a lockout time measurement on Channel B In addition to the manual selection of the four basic tests Single Rate Dual Rate PCA and Occlusion Pressure Infutest has the ability to create pump test protocols termed AutoSequences The nine 9 test sequences are user configurable to automate testing and data collection based on manufacturer or user test protocols AutoSequences may greatly improve on productivity by standardizing on test protocols and minimizing user setup time In addition to the two channel Infutest a Remote Sensor Module RSM may be added to expand the Infutest to a four channel system Throughout the manual wherever reference is made to the capabilities of Channel A or B or switching from Channel A to B this may be extended to include channels C and D if an RSM is connected All actions of the RSM are controlled by the Infute
9. AutoSequences An AutoSequence must have ENABLED set to Yes otherwise the sequence cannot be selected v a Infutest s START screen Test UsagelChapter 5 Page 73 INFUTEST 2000 OPERATING MANUAL The default INF TIMER settings are derived from Service Manual test protocols published by the manufacturers of Infutest s default infusion devices These test protocols typically require the user to program the device under test DUT with a RATE and Volume to Be Infused VTBI or Dose Refer to the manufacturer s service manual of the DUT to review the relevant test procedure usually referred to as a flow accuracy or volumetric test setup of the DUT and performance specifications or ranges of acceptance for device performance in these tests In accordance with the manufacturer s recommended test protocols the Infutest s default infusion devices should be programmed as defined in the table below prior to running the AutoSequence TABLE II AUTOSEQUENCE MANUFACTURER FLOW RATE AND MODEL NO SETTING ml hr ABBOTT PLUM XL or PLUM 5000 modet3o00 29 4 McGAW Horizon model 6201 Before running a default AutoSequence the device under test DUT should be set up primed and connected to Infutest A printer should be connected to Infutest s printer port and should be LINE prior to starting the sequence Default AutoSequences automatically output the Test Summary Report which cons
10. OPtestTime Delay the desired number of seconds 1 STA Send STOP command to Infutest 1 IFTdata Get Infutest s response play the test results on the screen PRINT PRINT TEST RESULTS 1 GSA4 GET OCCL PR results command 1 IFTdata Get data from Infutest and display g Occlusion pressure IFTdata Output I m finished sound PLAY O3L8EC Turn off the COM port CLOSE END Delay seconds This SUBroutine is called to produce a delay of seconds allowing Infutest some time to collect measurement data after a test has been started The time remaining in the delay is continuously posted on the screen The time remaining can be skipped by pressing the ESC key on the keyboard SUB Delay seconds row CSRLIN PRINT Time remaining in test seconds sec PRINT Press lt ESC gt key to stop test DO WHILE seconds gt 0 AND INKEY lt gt CHR 27 Wait here for 1 0 seconds Tzero TIMER DO WHILE TIMER Tzero lt 1 LOOP 1 second elapsed decrement seconds counter seconds seconds 1 Update time posted on screen LOCATE row 25 PRINT seconds LOOP END SUB Remote ControllChapter 6 94 INFUTEST 2000E OPERATING MANUAL Example 3 Serial download from AutoSequence AUTOSEQ BAS AutoSequenced Test with Data Saved to File c Datrend Systems Inc 2005 This QBasic program illustrates how to use Remote Control commands to run an Infutest A
11. The Infutest incorporates a time date clock and a data logger capable of storing up to 900 flow measurements and 700 occlusion pressure measurements per channel A flow measurement comprises elapsed time in hours minutes and seconds flow rate average flow total effused volume and back pressure for the Single Rate Dual Rate and PCA Pump Tests A pressure measurement comprises elapsed time occlusion pressure and Nurse Call Alarm status for the Occlusion Pressure Test When an RSM is connected to the Infutest the data log is initialized to 450 flow and 350 pressure measurements for each of the four channels The Infutest also provides a Summary for each channel A Summary condenses the raw data obtained from a test into a few important values such as the average flow measured during the test and the total volume of fluid that was effused An Occlusion Pressure Summary is also included to provide a synopsis of Occlusion Pressure Test results Upon completion of a test contents of the channel Data Log the channel Summary or both may be output to a printer or downloaded to a personal computer via the serial port Multiple copies of the test results may be output in succession and each copy may be directed to either the printer or the serial port at the user s option Overview Chapter 2 Page 11 INFUTEST 2000 OPERATING MANUAL To accommodate long term testing or special testing needs the Infutest may be controlled remotely
12. AutoSequence detection of a Nurse Call alarm will cause the AutoSequence to stop the occlusion test and begin the automatic report printout ot download if enabled Test UsagelChapter 5 Page 72 INFUTEST 2000 OPERATING MANUAL 5 6 AutoSequences 5 6 1 Running Default Test Sequences Infutest is supplied to you with 9 automatic test sequences in battery backed memory These AutoSequences may be viewed enabled and edited by powering up the instrument and pressing the EDIT SEO key following the self test The first six default AutoSequences ate programmed as defined in the following table The sequences include a timed Single Rate Test with the duration of the test being set by the Report to the printer NF I MER followed by automatic output of the Test Summary TABLEI Sequence Parameter Factory Default Setting MFR MOD REMARK Depends on pump make model RATE TEST Single Rate OCCL TEST Off AUTO OUTPUT Test Summary Report OUTPUT TO Default AutoSequences 7 8 and 9 are almost identical ENABLED RATE TEST AUTO OUTPUT and OUTPUT TO fot these sequences ate the same as shown INF TIMER Depends on manufacturer s test protocol above For default AutoSequences 7 8 and 9 INF TIMER is set to 180 sec and OCCL TEST is set to 1 min MFR MOD and REMARK are left blank The EDIT SEQ screen may be used to edit the above settings as desired Refer to Section 4 10
13. Care providers may produce the most non steady flow of the devices mentioned so far Such pumps often deliver fluid by alternately turning on and off the motor of a rotary peristaltic mechanism Since the motor runs at one speed the duration of the motor s on cycle and the interval between on cycles determines the flow rate The bolus delivered in each on cycle may range from 0 2 ml to 2 ml with the zero flow interval between bolus deliveries ranging from a few seconds to several minutes Infutest s status indicator will show VPF when testing such devices and the FLOW graph may show large periodic rises and falls at rates over 100 ml hr Test UsagelChapter 5 Page 78 INFUTEST 2000 OPERATING MANUAL Because of these differences in short term delivery characteristics pump manufacturers choose to specify the accuracy of their products based on Average Flow or the total volume delivered in a test divided by the total time For most pumps operating at 50 to 500 ml hr Infutest s AVG graph will stabilize to a straight horizontal line after running the Single Rate Test for 5 to 10 minutes At this point most of the pumps described above will have produced a stable enough reading to verify the pump s accuracy Note this limit on the minimum test time is due to the quality and design of the pump being tested not the Infutest You should find flow accuracy or volumetric test procedure in the Service Manuals of the infusion devices you
14. Pacte ph ee Rr p PY gh Eae Da 8 2 OVERVIEW OF INSTRUMENT ii ex 9 2 1 General Description roh edite x ER eR MEN NE EX ea EE MR t 9 2 2 Description of Test Procedures a saa die za sacs oe so AR o OR d 13 2 2 1 Single Rate Test o ase onm eve n vede rens 13 2 2 2 Dual Rate TOS xia dex tix NR UA RAE Woah Gud a Wotan aod MASA AU 14 22 3 PCA P mp TeSt e scu ec oM xs Madd ching di ies 14 2 2 4 Occlusion Pressure Testen ete an a eR e tace mE e se 14 DOSE IUICIS tars Xe elt te E ule ath BAR dude Qut E bes ee P Dat 15 S INETPAE SETS a art a ud fane d 17 Sul GOMNBCHONS sar duet oe ed ore eee ob ee done weeded 17 Sub Pm ooo n acct eta mts accra et rr tn eaten as ix atero 18 3 3 Optional Connections id 24058 aah to eek iat tee ek eat dat ead 22 4 OPERATION AND RELATED DISPLAYS 25 4 1 Powering Up and Setting the 25 4 2 S Setting Up a ate EE lan Bugs he 28 4 3 Test Measurement Concepts 31 4 95 Sync OSA avus ants doce Sot Joe s 2a eo ati Sex xen dee ee wee 31 4 3 2 End of Infusion Analysis o eese geo evo em e ee Ee 31 4 3 3 Flow Pattern Classification 31 AA Test uto sud S tueri te ek ad Rec
15. THE WARRANTY Items such as cables and non serialized modules are not covered under this warranty This warranty gives you specific legal rights and you may have other rights which vary from province to province state to state or country to country This warranty is limited to repairing the instrument to DSI s specifications When you return an instrument to DSI for service repair or calibration we recommend shipment using the original shipping foam and container If the original packing materials are not available we recommend the following guide for repackaging Use double walled carton of sufficient strength for the weight being shipped e Use heavy paper or cardboard to protect all instrument surfaces Use nonabrasive material around all projecting parts e Use at least four inches of tightly packed industrial approved shock absorbent material all around the instrument DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper packaging or handling All warranty claim shipments must be made on a prepaid basis freight duty brokerage and taxes No returns will be accepted without a Return Materials Authorization number Please contact Datrend at 1 800 667 6557 to obtain an RMA number and receive help with shipping customs documentation Page ii Warranty Disclaimer Should you elect to have your instrument serviced and or calibrated by someone other than Datrend Sy
16. Test soft keys to pre empt the new test and recall results obtained from the last test executed on Channel A Note the Data Log and Summary of the Infutest channel are NOT erased until the GO key is pressed the START screen At any time before this the user may abort the start of a new test and recall the Summary and or Data Logs for the previous test by means of the PREV TST soft key on the START screen Note This following Menu item is not available in the German language version Press more and then SET RATE to view the SET RATE menu Figure 12 By means of this menu Infutest can be enabled to calculate a percentage error between a Set Rate value in milliliters per hour and the Average Flow Rate as measured and reported by Infutest upon conclusion of a Single Rate Test SET RATE CHAN A RATE ERROR Enable SET RATE 100 ml h MODIFY SELECT Figure 12 SET menu Channel A You can use the menu of Figure 12 to input the flow rate setting of the infusion device which is being tested While viewing the SET RATE menu press SELECT to toggle the prompt between RATE ERROR and SET RATE then press MODIFY to change the indicated item RATE ERROR may be set to either Enable or Disable the per cent error calculation which is performed at the end of a Single Rate Test With the prompt at SET RATE pressing MODIFY causes the editing keys of Figure 13 to appear at the bottom of the screen
17. accidental contamination with dextrose TPN solution the following procedure should be adequate provided cleaning is performed immediately following contamination If cleaning does not appear to improve test results i e flow measurements are persistently erratic low or nonexistent contact your dealer and or Datrend Customer Service a Make up about 200 ml of cleaning solution by mixing 100 ml of distilled water with 100 ml of Sudsy Ammonia household cleaner e g AMEX brand by Colgate Palmolive Inc If Sudsy Ammonia is not available in your area add one half teaspoon of liquid dish detergent to the 200 ml of ammonia and water solution b Fill a disposable 60 ml syringe with the cleaning solution and discharge the syringe quickly into CHANNEL A at about 2 ml per second Don t use the same syringe you use to prime the Infutest because the cleaning solution will remove the syringe s lubricant Refill the syringe and inject CHANNEL B with the cleaning solution in the same mannet Test UsagelChapter 5 56 INFUTEST 2000 OPERATING MANUAL c the syringe with 20 ml of cleaning solution and connect the syringe to CHANNEL A Inject about 10 ml into the channel Under no circumstances should you quickly draw solution back into the syringe as the excessive suction may damage the pressure sensors d Repeat c for CHANNEL B e Letthe cleaning solution sit in the Infutest for about 10 to 15 minutes DO NOT leav
18. best to flush the channel before running a Single Rate Test Test UsagelChapter 5 59 INFUTEST 2000 OPERATING MANUAL 5 2 Single Rate Test 5 2 1 Test Description The Single Rate Test is the test you will select in most cases to verify flow and volumetric accuracy on all types of infusion devices ranging ftom acute care to home care pumps and including syringe pumps linear peristaltic pumps cassette pumps ambulatory pumps and enteral feeding and TPN TNA pumps The Single Rate Test measures flow over two ranges LOW and HIGH The LOW range is used for measuring flow below 170 ml hr and the HIGH range above 170 ml hr up to 1200 ml hr Transparent to the user the Infutest selects the most appropriate flow range automatically at the beginning of the Single Rate Test through execution of both range selection and flow pattern recognition software algorithms These algorithms will select the HIGH range if pulsatile or erratic flow is detected at the start of the test For pulsatile flow patterns a greater degree of volumetric averaging is applied to increase the accuracy of the flow measurement however measurement time may be substantially increased For pulsatile flow with an average tate of 5 ml hr a single measurement will require nearly 14 minutes to complete as opposed to a nominal 11 seconds for 5 ml hr continuous flow The type of flow detected will be displayed in the flow status indicator which appears in th
19. is started such extraneous bubbles may cause the flow and volume displayed to be multiplied by a factor of two or more If for example you ate testing a pump set to 400 ml hr and Infutest consistently reads around 800 ml hr or higher the error may be because the fluid channel was not flushed before the Single Rate Test was started This is the primary risk of not flushing the channel before test startup If the device under test is known to produce continuous flow and the device is being tested at rates below 170 ml hr this multiplication error maynot occur and so flushing prior to starting the Single Rate Test is optional The Infutest incorporates software algorithms to reject most air bubbles in the test fluid which arise from outgassing and which may accidentally drift into the fluid channel while running a test The Infutest will also reject some air bubbles in the fluid channel which it detects at test startup Infutest s bubble rejection software is highly effective in the Dual Rate and PCA Pump Tests which operate over a restricted range of flow rates up to 170 ml hr Flushing the fluid channel prior to starting a Dual Rate PCA Pump or Occlusion Pressure Test is rarely necessary unless the channel is completely dry However the bubble rejection software of the Infutest is somewhat less effective in the Single Rate Test than the other tests due to the extended range of flows which may be measured up to 1200 ml hr It is always
20. memory ENTER SET SET SELECT Figure 25 PUMP ID editing keys e The PUMP ID is continuously retained in the battery backed memory of the Infutest with power on or power off until the ID is changed by the user prevent the displayed PUMP ID from appearing in the Summary or Data Log output without actually editing or erasing the PUMP ID simply set ID TYPE to None f If output to a personal computer via the Infutest Serial Port is desired the user must first run a terminal emulation communication program after connecting the Infutest to one of the PC s COM ports Set up the COM port as follows 9600 baud No parity 8 bits character 1 stop bit Ensure that the correct COM port on the PC has been selected otherwise the download will not be initiated Refer to Section 3 3 for complete serial interface details g Once the REPORT PORT ID TYPE and if applicable the PUMP ID have been set as desired press GO to initiate the printout or download of the Summary or Data Log report h The data output system incorporates an output queue to handle all data output If the Infutest is already outputting data on either the serial or parallel port the STATUS line will read BUSY and the GO soft key will be changed to QUEUE Pressing the QUEUE key will place the output job into the output queue and the STATUS line will change to QUEUED If there is nothing already in th
21. not all IRC commands are compatible with all systems Refer to the operator s manual for your instrument especially with regard to serial port settings serial cable wiring data transmission format and data packet length This section of the manual describes the IRC commands and provides command examples Remote ControllChapter 6 Page 81 INFUTEST 2000 OPERATING MANUAL 6 2 Connections a Connect Infutest s serial port to your controller s serial port using an RS 232 extension cable with a DB 25 female connector at the Infutest end If your controller is a personal computer use an RS 232 cable with a DB 25 or DB 9 female connector for the computer end and connect to COM1 or COM2 of the computer an accessory RS 232 cable for use with the Infutest is available from Datrend Systems SSC 1 Each pin on the Infutest serial port connects to the same pin on your controller s serial port do NOT use a null modem cable or null modem adapter However use of a commonly available RS 232 computer to modem cable with a gender changer is acceptable Set the serial port on your controller as follows 9600 baud NO parity 8 data bits 1 stop bit d Refer to Section 3 3 tor complete serial interfacing details 6 3 Command Syntax All IRC commands follow the following very simple format COMMAND chan parameter where the COMMAND consists of two UPPER CASE letters chan is the channel of interest also UPPER CASE and
22. parameter is an additional numerical function parameter if required The complete command totals four 4 ASCII characters terminated by a carriage return OD hex and or a line feed OA hex For the basic Infutest the channel may be either A or B If a Remote Sensor Module RSM has been connected channel may also include C or D Remote ControllChapter 6 82 INFUTEST 2000E OPERATING MANUAL 6 4 Command Types and Return Values Test Control Commands are used to start or stop tests and AutoSequences If a Test Control command is received Infutest will return one of the following Acknowledged test may be started stopped Syntax error e Error test already running on channel n Channel specified does not exist Report Output Control Commands are used to put Summary or Data Logs for a completed test into the output queue Infutest will return one of the following Acknowledged output job has been queued Syntax error n Channel specified does not exist Get Data Commands are used to obtain specific data from Infutest s memory either during after a test If a Get Data Command is received Infutest returns the requested data as a string of up to 34 ASCII characters or one of the following error codes Syntax error e Test AutoSeq not stopped if summary data requested Test AutoSeq not started if real time data requested x No new data available if real time data requested n Channel specified does not exi
23. sec max above 6 ml hr f Accuracy Average flow t 1 0 1 1200ml hr g Ranges LOW 0 1 to 170 ml h HIGH 170 to 1200 ml h h Range selection Automatic i Internal nominal effective collection volume LOW range 0 014 ml HIGH range 1 1 ml IntroductioniChapter 1 Page 1 INFUTEST 2000 OPERATING MANUAL II III IV 1 1 2 II Volume Measurement a Range b Maximum display resolution c Accuracy Back Pressure Measurement a Range b Zeto offset error c Display resolution d Accuracy Elapsed Time Measurement a Range b Display format c Accuracy Pulsatile Flow Conditions Flow Measurement Nominal range Maximum display resolution Measuring time o coc f Accuracy Average flow g Ranges h Internal nominal effective collection volume Volume Measurement a Range b Maximum display resolution Accuracy Introduction Chapter 1 2 Maximum flow measurable and displayed Minimum flow measurable and displayed 0 9999 ml 0 001 ml 1 0 300 mmHg 5 mmHg 1 mmHg 1 FS zero offset error 0 100 hours hh mm ss 0 1second 5 1200 ml hr 1700 ml hr 2 75 ml hr 0 001 ml hr 14 min at 5 ml hr 20 sec max above 200 ml hr 1 HIGH range only internally selected 1 1 ml 0 9999 ml 0 001 ml 1 INFUTEST 2000 OPERATING MANUAL III IV Back Pressure Measurement Same a
24. size Appendix B 107 INFUTEST 2000 OPERATING MANUAL remains independent of pressures or moderate vacuums applied at the A amp B Output As shown in Figure 36 the collection tank of the pneumatic feedback system is mostly filled with air Because of this fluid draining from the Output is poorly correlated with flow entering the input B 3 Pressure Measurement System Figure 34 shows a pressure transducer located at each channel s input During Single Rate Dual Rate and PCA Pump Tests the transducer is used to measure pressure in the channel which is displayed as Back Pressure During the Occlusion Pressure Test a solenoid valve on the Sensor Chassis is activated which blocks fluid flow downstream of the pressure transducer Pressure developed by the infusion device against the blockage is sensed by the transducer and displayed e UM we PUMP 5 INPUT i COLLECTION TANK 27 ARN OUTPUT M WATER DRAIN mall Figure 36 Flow Sensing System Appendix B 108 INFUTEST 2000 OPERATING MANUAL Appendix ww APPENDIX C CALIBRATION C 1 Annual Calibration Calibration of Infutest by a Datrend Authorized Service facility is recommended on an annual basis and is requited to extend the p
25. to automatically start and stop tests and download test results into the medTester via the serial communications interface If you wish to interface the Infutest with a medTester please contact Datrend Systems for further information Remote ControllChapter 6 99 INFUTEST 2000 OPERATING MANUAL Remote ControllChapter 6 Page 100 INFUTEST 2000 OPERATING MANUAL Appendix Y Y 1 1 7 A y 7 APPENDIX A BACK PRESSURE TESTING A back pressure may be applied by the user to the infusion device under test DUT to oppose the flow from the device Back pressures up to 300 mmHg may be applied during the Single Rate Dual Rate and PCA Pump Tests at the A amp B Output of the Infutest The Infutest will measure and display the back pressure during each of these tests This appendix describes apparatus and provides instructions for testing an infusion device with a pneumatically applied back pressure The test apparatus and method discussed are similar to those recommended by the Association for the Advancement of Medical Instrumentation AAMI in their proposed standard for infusion devices Connect the apparatus shown in Figure 33 to the A amp B Output of the Infutest as illustrated The flask should have a large internal volume 1 to 2 litres so that the fluid level within the flask does not change substantially during the test The components and all seals should be capable of withst
26. to jump to the occlusion pressure portion of the automatic test sequence In the occlusion pressure test screen Figure 15 the operator will be presented with the STOP soft key to end the test prior to the preset time of the AutoSequence and start the automatic data output if data output is enabled OperationIlChapter 4 Page 35 INFUTEST 2000E OPERATING MANUAL 4 6 Viewing the Test Summary 4 6 1 SUMMARY Screen for Single Rate Test Figure 16 is SUMMARY screen for a Single Rate Test performed on Channel A SUMMARY CHAN A Jan 10 09 51 SINGLE RATE OCCL PRESSURE TEST Infusion Time 00 16 01 Volume Infused 2 642 ml Average Rate 9 900 ml h Back Pressure o mmHg OUTPUT CHANNEL OCCL PR START Figure 16 SUMMARY screen for Single Rate plus Occlusion Pressure Test Channel A The definition of the mnemonics displayed on the screen is Test is the type of test that was executed SINGLE RATE DUAL RATE PCA PUMP or OCCLUSION PRESSURE If an Occlusion Pressure Test was enabled in an AutoSequence for a Single Rate Dual Rate or PCA Pump Test the label OCCL PRESSURE TEST will appear with the title of the initial test as shown in Figure 16 Infusion isthe duration of the test in hours minutes and seconds Time Volume is the total volume of test fluid that was effused during the test in Infused milliliters Average is the flow rate averaged over the duration of the test in milliliters Rate per hour If p
27. to the Infutest parallel Printer Port Figure 2 The parallel Printer Port accepts a DB 25 male As an alternative or in addition to a above a personal computer PC or other data collection instrument may be connected to the Infutest Serial Port Figure 1 The Infutest Serial Port is configured as Data Communications Equipment DCE except that the Infutest Serial Port accepts a DB 25 female to distinguish it from the parallel Printer port Connect the Infutest to the COM port of a personal computer with a RS 232 cable having a DB 25 female at the Infutest end and a DB 25 or DB 9 female at the computer end Each pin on the computer s DB 25 connects to the same pin on the Infutest s DB 25 do not use a null modem adaptor or a null modem cable Alternatively you may use a conventional computer to modem RS 232 cable with a double female gender changer attached at the male end of the cable RS 232 cables for connecting the Infutest to a personal computer are available as accessories from Datrend Systems See Section 1 7 The Infutest Serial Port both transmits and receives and is configured as follows 9600 baud No parity 8 bits character 1 stop bit Infutest PC communications rely on hardware handshaking via the CTS lines The Infutest holds the CTS line high continuously The Infutest Serial Port may also be connected to an external controlling device to facilitate remote test control and data down loading For example th
28. 0 1 170 ml hr For high range flow 170 1200 ml hr optosensor 3 and the output optosensor 16 are used Continuous flow measurement is performed by injecting a new bubble every time the preceding bubble passes the fifteenth low range or sixteenth high range optosensor Volume of the glass capillary tube between adjacent optosensors is calibrated at the factory to within 0 0000052 ml using a precision microsyringe dispensing system These volume calibrations along with other flow sensor and pressure sensor calibrations are programmed into the TCO EEPROM Flow measurement is accomplished based on a transit time principle As described volume of the glass tube between optosensors is known precisely Flow 15 derived by measuring the time required for the bubble to cross these calibrated volumes Volume is derived by summing up the calibrated volumes incrementally as the bubble crosses them Signals from the optosensors are continuously analyzed and dynamic corrections may be applied by the software algorithms depending on rate and the fluid delivery pattern of the device under test flow pattern analysis Figure 36 illustrates how each flow sensor is incorporated into the patented Infutest flow sensing system After the test fluid passes through the flow sensots the fluid is collected in a large tank inside the Infutest before draining out the A amp B Output Pneumatic feedback from the tank to the air pump ensures the injected bubble
29. ENDIX A BACK PRESSURE TESTING 101 APPENDIX B OPERATIONAL OVERVIEW 105 B 1 General Description 2 secu see RE ED ta dal ERE Rex ss 105 B 2Flow Measurement System 106 Pressure Measurement System 108 APPENDIX C CALIBRATION 0000 cece 109 C Anndal GallBratio 3o sted ore eared Gade gles oe eee eee 109 G2 Calibrall n Verification xs oct Rer aerial steed ee QU t a e ated ate 110 C 2 1 Pressure Accuracy Verification Field Test 110 C 2 2 Flow Accuracy Verification Field Test 110 Table of Contents Page vii INFUTEST 2000 OPERATING MANUAL Table of Contents Page viii INFUTEST 2000E OPERATING MANUAL Chapter Introduction This chapter provides the performance specifications of the Infutest 2000E Infutest Infusion Device Analyzer 1 PERFORMANCE SPECIFICATIONS The following specifications apply to both channels of the Infutest 2000 Series E Dual Channel Infusion Device Analyzer 1 1 Single Rate Test 1 1 1 Continuous Flow Conditions I Flow Measurement a Nominal range 0 1 1200 ml hr b Maximum flow measurable and displayed 1700 ml hr c Minimum flow measurable and displayed 0 04 ml hr d Maximum display resolution 0 001 ml hr e Measuring time 10 min at 0 1 ml hr 20
30. ING MANUAL b Now rotate the Channel A stop cock to OFF and the Channel B stop cock to PRIME Repeat a above for Channel B c Prepare the device under test DUT by loading the device with an administration set and priming the set with water according to the manufacturer s instructions Connect the primed set to the Channel A stop cock and set the stop cock to ON d Prepare a second DUT as above and connect it to Channel B e To test a single infusion device connect the device to either Channel A or Channel B as desired and set the other channel s stop cock to OFF This will prevent water from draining out the unused channel s input if any pressure is developed within the internal fluid system If the input tubing set is not connected the Delrin twistlock input connector has an internal seal which will prevent fluid backflow f Ifnormal saline solution must used as a test fluid against Datrend s recommended practice prime as described above and flush the channel with distilled water immediately following the test Under no circumstances should an instrument channel be used or left primed with saline for an extended period of time g Unless the Infutest is stored for several months at a time leave the instrument primed between uses Following use flush the Infutest with distilled water set both channel stop cocks to OFF and store the instrument in the horizontal position IMPORTANT It is best to use a new administ
31. L PRES CHAN A mmHg psi Time 00 46 5004 10 Pressure 2504 5 5 2 psi 268 mmHg t CHANNEL STOP RESTART Figure 15 TEST screen for an Occlusion Pressure Test Channel A Pressure is the pressure obtained at the input at time mmiss after the channel has been internally occluded in units of psi and mmHg The right half of the TEST screen is reserved for the real time graph of either instantaneous and average flow or occlusion pressure The vertical axis is scaled automatically based on graph type and initial measurement data Rather than absolute time in minutes the horizontal axis represents time in number of measurements each tick indicating three consecutive data points As the test proceeds the graph scrolls to display data from the most recent 15 measurements The top right corner of the TEST screen is reserved for displaying test status messages and the blinking flow status indicator which indicates the test is in progress The Dual Rate PCA Pump and Occlusion Pressure Tests have a number of status messages which appear at this location in addition to the flow status indicator shown in Figure 14 Operation Chapter 4 34 INFUTEST 2000 OPERATING MANUAL The test status messages are Status Message Dual Rate PCA Pump RATE N the infusion device is currently operating at preprogrammed flow rate number N where N 1 or 2 WARNING PUL the infusion device produces pulsatile flow Switc
32. RATING MANUAL NNN and NNN 1 mm minutes ss seconds Occlusion Pressure test data 55 PP P pppp Where R occlusion pressure data indicator mm elapsed time minutes SS elapsed time seconds PP P pressure psi pressure mmHg End of Occlusion test data lt type gt mm ss PP P pppp Where T for nurse call alarm data lt type gt S for maximum pressure data mm ss PP P U for overpressure data exceeded 50 psi elapsed time minutes elapsed time seconds pressure psi pressure mmHg Error Codes Returned X e n No new data available from LCD since last GR command received No Data Ready Syntax error Test AutoSequence not running Channel specified does not exist 6 7 Programming Examples 6 7 1 QBasic Programming This section provides some examples of BASIC programs for controlling Infutest MS DOS QBasic program version 5 0 and 6 0 owners will be able to use Microsoft s The examples provided in this chapter were wtitten for QBasic version 1 0 and assume some familiarity with BASIC or other programming languages The examples include comments to explain what each program and each line does Remote ControllChapter 6 Page 90 INFUTEST 2000 OPERATING MANUAL Editing the programs to perform alternate tasks or translation of the programs to Visual Basic or other compilable languages should be straightforward Assuming your PC is e
33. RTICULAR PURPOSE OR APPLICATION THIS PRODUCT CONTAINS NO USER SERVICEABLE COMPONENTS UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES Fluke is a registered trademark of Fluke Corporation MS DOS QBasic Visual Basic and Visual C Microsoft and Windows are registered trademarks of Microsoft Corp Brita is a registered trademark of BRITA Worldwide Jet Dry is a registered trademark of Reckitt Benckiser plc Page iii Page iv INFUTEST 2000 OPERATING MANUAL Table of Contents 1 PERFORMANCE SPECIFICATIONS 000 000 te ee 1 Ad OINGIS Rate TeSt o sers itcr heo kac 325 4 Josep Dore M ced que vos Se aee s 1 1 1 1 Continuous Flow Conditions eame hme e e Ee cepe e URS 1 1 1 2 Pulsatile Flow Conditions isse RE ERR RUE ERU KORR 2 12 DUAL Fate TBSE Rie ie XO t Ride Cice e dd Qe acte D d s 3 1 2 1 Continuous Flow Conditions ONLY 3 Lote CA PUMP NES s d e at uem t med tertium 8 hd Medd da diee Nd da qe idus 4 1 3 1 Continuous Flow Conditions ONLY 4 1 4 Occlusion Pressure Test s os eod De eee ed ER 5 1 4 1 Pressure Measurement 0 000 e eee ee 5 1 4 2 Nurse Call Detection ou ln o rcg QU aaa 5 Tata OGG 2 esso tcu REA RE RE RIA QE Ara dta Gray 5 REA mE a Mee RES eua Sale uo were ue EE uc e 6 TU ABDBSSOINBS quit wl
34. S DSO OPO RB2048 TB32 FOR RANDOM AS 1 Clear the PC s screen CLS Display some reminders on the screen PRINT Flush Channel A and start device pumping PRINT Input testing times for Single Rate and Occlusion Pressure portions of the program INPUT Enter duration of Single Rate Test sec SRtestTime INPUT Enter duration of Occlusion Pressure Test sec OPtestTime Conduct a Single Rate Test if test time was not set to zero IF SRtestTime lt gt 0 THEN RINT RINT Executing Single Rate Test RINT 1 RTA1 Send START command to Infutest Chan A SR Test UT 1 IFTdata Get Infutest s acknowledge response SRtestTime Delay the desired number of seconds 1 STA Send STOP command to Infutest 1 IFTdata Get Infutest s response play the test results on the screen PRINT PRINT TEST RESULTS 1 GSAL GET Summary up to 34 ASCII characters 1 IFTdata Get and display data from Infutest Remote ControllChapter 6 93 INFUTEST 2000 OPERATING MANUAL Example 2 Single Rate With Occlusion Test cont d RINT Time Volume Average Flow RINT IFTdata RINT END IF Conduct an Occlusion Pressure Test if test time was not set to zero IF OPtestTime lt gt 0 THEN RINT RINT Executing Occlusion Pressure Test RINT 1 RTA4 Send START command to Infutest Chan A OP Test 1 IFTdata Get Infutest s response
35. TEST 2000 OPERATING MANUAL 1 6 Interface I II III IV VI VII VIII User Interface Fluid interface Inputs A and B Common output A amp B PCA Pump Trigger Outputs Mechanical Electrical Nurse Call Inputs Mechanical Electrical Parallel Port Printer Driver Serial Port Mechanical Electrical 40 character by 8 line backlit LCD 4 front panel soft keys Internal beeper LCD contrast control rear panel Delrin twistlock self sealing Delrin twistlock One 1 4 female stereo phono jack per channel Relay contacts rated at 120 VAC 1 A normally open and normally closed contacts available One 1 4 female stereo phono jack per channel 50K ohm differential input impedance Centronix standard printer interface DB 25 female connector Epson MX FX Series 80 cps 80 columns and 66 lines per page DB 25 male connector RS 232C bidirectional CTS handshaking 9600 baud 8 data bits no parity bit 1 stop bit Power Supply Input 100 240VAC 50 60 Hz Output 12 VDC 1A Min IntroductionIlChapter 1 6 INFUTEST 2000 OPERATING MANUAL IX Environment Operating Temperature 15 C to 40 C Operating Relative Humidity Range 10 to 90 RH Storage Temperature 0 C to 40 C Storage Relative Humidity Range max 90 RH Indoor Use Only Category II Pollution Degree 2 X Dimensions 12 W x 12 Dx 6 H 30 5 W 30 5 D x 15 2 cm H
36. TIMER infusion timer from running until flow from the DUT detected Synchronizing the startup of the Single Rate Test to the flow produced by the DUT is important for accurately measuring the cyclic fluid delivery produced by pulsatile infusion devices and also for measuring the actual volume delivered by a DUT in a preset VTBI Volume to Be Infused or DOSE The table below lists nominal times required for the Infutest to obtain measurements at selected flow rates The theoretical values listed are approximate and assume continuous flow conditions FLOW RATE MEASUREMENT TIME ml hr 15 to 20 minutes first measurement 0 1 10 minutes subsequent measurements 1 minute subsequent measurements 9 seconds Test UsagelChapter 5 Page 61 INFUTEST 2000 OPERATING MANUAL 5 2 2 Test Usage The most basic use of the Single Rate Test is to verify rate accuracy of an infusion device To verify rate accuracy program the device with the desired test Rate and disable the Volume to Be Infused V TBI or Dose Limit function on the device Alternatively you may set the VIBI or Dose on the device under test DUT to an arbitrarily large value e g 9999 ml Connect the DUT to Infutest flush the channel start the test on the Infutest press GO and then run the DUT The length of time you choose to run the Single Rate Test will depend on the type of pump you are testing see Section 5 7 Understanding Your Test Results Refe
37. al damage is found retain all packing materials in their original condition and contact the carrier immediately to file a claim If the instrument is delivered in good physical condition but does not operate within specifications or if there are any other problems not caused by shipping damage please contact your local sales representative or DSI immediately Standard Terms and Conditions Refunds amp Credits Please note only serialized products products labelled with a distinct serial number and accessories are eligible for partial refund and or credit Non serialized parts and accessory items cables carrying cases auxiliary modules etc are not eligible for return or refund In order to receive a partial refund credit the product must not have been damaged and must be returned complete meaning all manuals cables accessories etc within 90 days of original purchase and in as new and resalable condition The Return Procedure must be followed Return Procedure Every product returned for refund credit must be accompanied by a Return Material Authorization RMA number obtained from Datrend Customer Service All items being returned must be sent prepaid freight duty brokerage and taxes to our factory location Restocking Charges Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 Products returned in excess of 30 days after purchase but prior to 90 days are subject to a mi
38. all Alarm produced by the infusion device may be any one of the following signals 1 normally open or normally closed relay contacts ii open collector output TTL output iv RS 232 level or v 20 mA current loop Refer to the manufacturer s technical service manual for the infusion device being tested when preparing a Nurse Call cable for connection with the Infutest TO INFUTEST 2000 1 4 PHONO FROM PUMP NRS CALL INPUT NURSE CALL OUTPUT gt CURRENT LOOP SHIELD HIGH LOW OR PUMP GND lt Q CURRENT LOOP Figure 32 Schematic of unterminated Nurse Call cable NCA 1 available from Datrend Systems For voltage output Nurse Call connect the higher potential to ring and the lower potential or pump ground to tip For current loop Nurse Call connect so that current flows in direction of the arrows as shown above For relay output Nurse Call the polarity of the connection is arbitrary In all cases the shield of the Nurse Call cable must not be connected to the pump During the Occlusion Pressure Test the Nurse Call Alarm signal is sampled once every 200 msec and may be in either logical state at the start of the test A change in the state of the Nurse Call signal will cause the pressure to be sampled immediately and stored in the Data Log with a NRS CALL message The Occlusion Pressure Test is then automatically stopped If the Occlusion Pressure Test is part of an
39. anding the maximum pressure applied to the system Appendix 101 INFUTEST 2000E OPERATING MANUAL FROM COMPRESSED AIR SOURCE STOPPER PRESSURE REGULATOR VALVE INFUTEST 2000E IMPORIANI A amp B OUTPUT Figure 33 Apparatus for applying Back Pressure Alternatively a syringe bulb may be used to pressurize the flask instead of the compressed air source and regulator valve shown in Figure 33 This approach although simple has the disadvantage in that the back pressure is unregulated If air leaks are present within the system or if the water level within the flask changes substantially the back pressure will be affected and the test results may be invalid To perform a Single Rate Dual Rate or PCA Pump Test with an applied back pressure Power up the Infutest with NO PRESSURE applied to the A amp B Output During its power on self test the Infutest will auto zero the internal pressure sensor b Ifa back pressure is detected at the time of power up the Infutest will produce alarm via the SELF TEST screen Refer to Section 4 9 Alarms Appendix A 102 INFUTEST 2000 OPERATING MANUAL c After the START screen has been selected the fluid system of Figure 33 may be primed with water see Section 3 2 Priming and the flask pressurized up to a maximum of 300 mmHg before starting the test Under no circumstances should a vacuu
40. background processes After pressing the GO or QUEUE soft key the user may press the SUMMARY soft key and then recall other screens while the Infutest outputs to the Printer Port or Serial Port Operation Chapter 4 45 INFUTEST 2000 OPERATING MANUAL m An example of a Test Summary Report corresponding to the OUTPUT screen is provided in Figure 28 Note that each report output from the Infutest will include blanks at the bottom for the technician s name and signature INFUTEST 2000 E Datrend Systems Inc TEST SUMMARY REPORT Start of Test Date Aug 01 2005 Time 09 38 Infusion Device Information Manufacturer Model Serial No Control No ECN1234567 Department Location Set Rate s ml h VTBI Infutest ID EDC05080651 Channel A SINGLE RATE TEST Infusion Time hh mm ss Volume Infused VVVVV ml Average Rate RRRRR ml h Back Pressure mmHg Signature Figure 28 Format of Summary Report printout Operation Chapter 4 46 INFUTEST 2000 OPERATING MANUAL 4 9 Alarms On power up Infutest may detect an alarm condition which may or may not indicate the need for service The alarm message screen will appear following the self test screen Most FAULT conditions will require factory service while WARNING conditions will require a user action but should not prevent the use of the instrument 4 9 1 Nonrecoverable Alarms The following FAULT
41. conditions will require the unit to be returned to the factory ot authorized service center for service FAULT TCO SCI Serial Communications Error FAULT TCO RAM Memory Error RAM FAULT TCO ROM Memory Error ROM FAULT TCO EPM Memory Error EEPROM 4 9 2 Recoverable Alarms The following WARNING and FAULT conditions will require user action before proceeding but should not prevent the use of the instrument for testing WARNING UNIT UNPRIMED Both flow sensors are completely dry and MUST be primed with water before a test can be initiated This will normally only appear after extended periods of storage with no fluid in the sensors i e after delivery of unit from dealer WARNING NVRAM ERROR The data and clock backup battery on the unit may be too low to retain data on power down or the clock may be incorrect The instrument will operate correctly however the data in the Data Log may be corrupted when the power is turned off or the time and date in the tests may be incorrect The battery should be replaced at the earliest opportunity Operation Chapter 4 47 INFUTEST 2000 OPERATING MANUAL FAULT Pressure Vacuum Applied to unit When the power was applied the pressure at the input or output was either too high or too low to be zeroed out by the internal pressure zero circuitry This could be caused by incorrect positioning of the collection container ot by a pump runnin
42. conds Gradually priming a channel in this way will prevent disturbances appearing on the other channel The Infutest may be used to test infusion devices immediately after priming both channels as described above However after shipping the Infutest or following a period of dry storage optimum results are obtained if the internal flow sensors are first wetted before performing tests The Infutest may be wetted by first priming the instrument then running Single Rate Tests on Channels A and B at approximately 500 ml hr for 10 to 15 minutes refer to Section 4 Operation and Related Displays The preferred method of wetting however is to flush the instrument with Sudsy Ammonia solution and distilled water following the cleaning procedure given in Section 5 1 3 Cleaning Wetting is optional however cleaning the instrument regularly is recommended depending on usage For instruments in daily use with distilled or domestic water cleaning is recommended monthly A thorough cleaning is essential if the instrument becomes contaminated with fluids other than water dextrose saline etc The procedure for cleaning the Infutest and RSM is given in Section 5 1 3 Cleaning Set up Chapter 3 Page 21 INFUTEST 2000 OPERATING MANUAL 3 3 Optional Connections a If complete test results are to be retained for documentation purposes connect an Epson FX compatible printer 80 columns and 66 lines per page 80 characters per second
43. creen of Figure 8 All utility settings will be retained in the battery backed memoty of the Infutest when the power is off 4 2 S Setting Up a Test Pressing the START soft key on the power up screen causes the START menu for Channel A to be displayed Figure 11 This screen is used to select the particular test type or test AutoSequence before starting a test START CHAN A Jan 10 09 37 FLUSH channel to purge air bubbles Se es Push GO Then start pump TEST AutoSeq 1 IVAC 565 Set pump rate to 50 ml h GO CHANNEL SET TEST lt more gt Figure 11 START menu Channel A a Press the SET TEST soft key to select one of four manual tests Single Rate Dual Rate PCA Test or Occlusion Test or one of up to nine AutoSequences Auto Sequences must be enabled via the EDIT SEQ screen before they can be selected using the SET TEST key b Each of the manual tests will run until STOPped by the operator The AutoSequences can be set up to run a flow rate test an occlusion test and print or serially download the results automatically to increase the test productivity Prior to starting a test you may c Press the CHANNEL soft key to display a screen reflecting the current status of Channel B C ot D or d Press the more then EDIT SEQ soft keys to access AutoSequence editing ot Operation Chapter 4 Page 28 INFUTEST 2000 OPERATING MANUAL Press the lt more gt then PREV TST Previous
44. d and the typical data Infutest would return to the controller 6 6 1 Test Control Commands RUN TEST Starts a test running on a channel Format RT chan parm chan A B C or D parm 1 for single rate SR 2 for dual rate DR 3 for PCA 4 for occlusion OP Examples run SR test on channel A RTC3 run PCA test on channel C RSM only Returns Remote ControllChapter 6 Page 84 INFUTEST 2000E OPERATING MANUAL Acknowledged test may be started stopped Syntax error Error test already running on channel Channel specified does not exist DO 6 6 2 Test Control Commands RUN AUTOSEQUENCE Starts a preset AutoSequence running on a channel Format RSIchanlI parm chan A B C or D parm 1 for AutoSeq 1 2 for AutoSeq 2 Etc 9 for AutoSeq 9 Examples RSA1 run AutoSequence 1 on channel A RSD5 run AutoSequence 5 on channel D RSM only Returns Acknowledged test may be started Syntax error e Error test already running on channel n Channel specified does not exist Note that the controlling device must be ready to receive serial data transfer of up to 60 000 characters if AutoSequence AUTO OUTPUT is set to Summary or DataLog andifOUTPUT issetto SERIAL Remote ControllChapter 6 Page 85 INFUTEST 2000 OPERATING MANUAL 6 6 3 Test Control Commands STOP TESTIABORT AUTOSEQUENCE Stops a running test or aborts an AutoSequence in progress on the specif
45. e OperationIlChapter 4 44 INFUTEST 2000 OPERATING MANUAL i output queue pressing the GO key will change the STATUS line to PRINTING DOWN LOADING depending on the output port selected Refer to Figure Z6 tor an example of an output screen OUTPUT CHAN A REPORT Summary lt ID TYPE Contrl No PORT Printer PUMP ID ECN1234567 STATUS PRINTING SUMMARY CANCEL Figure 26 OUTPUT submenu showing print job in progress To terminate an output job in progress press the CANCEL key The Infutest will detect if the Printer is off line within approximately 10 seconds For the case of the Printer being off line or out of paper an alarm tone will be produced and the STATUS line will appear as shown in Figure 27 As instructed by the screen press the O K soft key when the problem has been corrected or press KILL ALL to abort the selected output job s OUTPUT CHAN A REPORT Summary lt ID TYPE Contrl No PORT Printer PUMP ID ECN1234567 STATUS Printer OFF LINE Push O K when ON LINE KILL ALL Figure 27 OUTPUT submenu showing Printer is off line When the selected output job is complete the OUTPUT screen will return to its initial state as illustrated in Figure 24 The user may now modify the OUTPUT and SEND TO parameters to output additional copies of the Summary or the Data Log to either the Printer or Serial Port as desired Output jobs are run as
46. e Infutest Serial Port may be connected to COM2 of a Fluke Biomedical medTester 5000C Use of a SSC 1 accessory cable is recommended The same CTS handshaking rules described above for the PC interface apply to external controllers such as the medTester Set up Chapter 3 22 INFUTEST 2000 OPERATING MANUAL d The pin connections for the serial interface cables are as follows DB9F All other pin connections are open circuit e In order to download test results from the Infutest Serial Port you must run a terminal emulator program on your PC eg Windows HyperTerminal Datrend Systems can provide a Windows based software program DTP which has been specially designed for this purpose In addition to the serial interface connection DTP incorporates a number of additional utilities for viewing editing and printing test data or converting test data to spreadsheet ot database compatible files as well as producing Flow versus Time graphing and Trumpet error graphs Set up Chapter 3 23 INFUTEST 2000 OPERATING MANUAL Set up Chapter 3 24 INFUTEST 2000 OPERATING MANUAL Operation Chapter y This chapter describes the operation of the Infutest controls and the associated LCD screen displays In addition you are instructed how to modify the default settings and AutoSequence protocols 4 OPERATION AND RELATED DISPLAYS Powe
47. e STATUS indicator will be LOW or HI depending on the rate If the flow is delivered in very small spurts the indicator will be PUL If the flow is delivered in large pulses as in many home care pumps the indicator will be VPF and the rate will be measured on the HI range sensor This may increase the flow measurement times for pulsatile pumps measured at low flow rates 4 31 INFUTEST 2000E OPERATING MANUAL 4 4 Starting a Test Following the prompts on the START screen the flow sensor for the channel in use should be primed then simply press the GO soft key and start the infusion pump to begin the test The infusion pump under test does not need to be started until the GO key has been pressed If the pump has an unusual high flow condition that appears only on startup the pump may be started first This may avoid the automatic selection of the high range flow sensor when the pump is running at low rates OperationIlChapter 4 32 INFUTEST 2000E OPERATING MANUAL 4 5 Running a Test A running test will produce a display similar to that illustrated in Figure 14 As shown in the figure the top line of the TEST screen is reserved for the name of the test on the left SINGLE RATE DUAL RATE PCA PUMP or OCCL PR the channel identifier label in the center CHAN A or CHAN B and the current test status on the right BOLUS RATE plus the flashing flow status
48. e alarm you will disrupt Infutest s End Infusion Analysis feature and the Primary volume as measured by Infutest may be erroneously HIGH see Section 5 2 2 Test Usage Single Rate The Volume Infused displayed on Infutest s SUMMARY screen will flash to indicate this uncertainty in the End Infusion Analysis Some DUT s produce a brief audio visual indication at the end of the Secondary delivery Do not confuse this indication with the DUT s End Of Infusion alarm Audio tones produced at the conclusion of the Secondary delivery are usually not persistent whereas an End Of Infusion alarm will persist until the ALARM SILENCE or equivalent button on the DUT is pressed Stopping the Dual Rate Test at the appropriate time is important to obtaining an accurate measure of the Primary infused volume Infutest s programmable AutoSequences provide an infusion timer INF TIMER which may reduce uncertainty in the timing aspect of the Dual Rate Test Refer to the programming instructions in Section 4 10 AutoSequences Note that for a Dual Rate Test you will program the INF TIMER based on the expected durations of the Secondary delivery plus the Primary delivery as follows INF TIMER Secondary VTBI ml Secondary Rate ml h 3600 Primary VTBI ml Primary Rate ml h 3600 5 3 2 Testing Titrated Rates Some infusion devices although unable to switch flow rate automatically allow the user to change the rate whil
49. e software version of the Display Unit ie 3 7 3 2 Appendix B Page 105 INFUTEST 2000 OPERATING MANUAL CHAN A PRES SENSOR CHAN 2 CHASSIS A amp B OUTPUT I fe ON FLOW VALVE x SIGNALS CONTROL PRES lt V SENSOR lo gt TEST T CONTROLLER TCO PCA TRIG lt lt DATA DISPLAY UNIT AS lt AUX LCD KEYPAD Figure 34 Infutest Block Diagram B 2 Flow Measurement System Figure 3515 schematic diagram of the patented Infutest flow sensor Pressure developed by an air pump is released through an injector valve introducing an air bubble into the flowing fluid via a needle located at the sensor input Fluid entering the flow sensor pushes the injected bubble through a glass capillary tube having an end to end volume of approximately 1 2 ml Bubble position is tracked continuously using an array of 16 optical sensors located along the glass tube as shown in Figure 35 Appendix B 106 INFUTEST 2000E OPERATING MANUAL AIR E PUMP NEEDLE AIR BUBBLE WATER GLASS TUBE OUTPUT INJECTOR VALVE Yu UN FLOW OPTICAL SENSORS INPUT lt Low RANGE lt HIGH d RANGE Figure 35 Flow Sensor schematic diagram The first 15 optosensors are used to measure flow over the low range
50. e the cleaning solution in the Infutest any longer than 15 minutes as prolonged exposure to the solution may damage the neoprene seals of the internal valves f Rinse the fluid channel thoroughly with distilled water to remove all ammonia from the fluid system Ifthe fluid system has been contaminated with a sticky liquid e g D5W D25W TPN solution etc you may need to perform this procedure using undiluted Sudsy Ammonia to clean the flow sensors In this case DO NOT leave ammonia in the Infutest for more than 10 minutes and be sure to thoroughly flush the instrument with distilled water afterwards 5 1 4 Input and Output Connections The input tubing sets supplied with your Infutest incorporate a calibrated flow restriction so as to be in conformance with IEC recommendations simulating viscous fluids 601 2 24 Pt 2 Always connect the device under test DUT to the flow restriction not the prime flush port of the input stopcock see Figure 4 Do not attempt to bypass or remove the flow restriction Accutacy of the Infutest is specified only with the IEC flow restriction in line When using only one Infutest channel to test a single infusion device do not leave the unused channel s input open to air Ensure that the stopcock of the unused channel is rotated to the CHANNEL OFF position to block off the unused input see Figure 6 If the unused input is not blocked Infutest s internal fluid system will fill up and will ev
51. e the device is pumping This feature is sometimes referred to as titration Provided the flow rate can be reduced quickly enough the Dual Rate Test may be used to evaluate a titratable infusion device at two different rates without stopping the test Although using the Dual Rate Test may be quicker than conducting two Single Rate Tests in succession the restrictions desctibed in the previous section must be observed Test UsagelChapter 5 Page 65 INFUTEST 2000 OPERATING MANUAL 5 3 3 Testing KVO Operation Most infusion devices incorporate Keep Vein Open KVO function Such pumps will automatically switch to the KVO Rate after delivery of a preset Volume to Be Infused VTBJ or Dose The KVO Rate depends on the make and model of the infusion device being tested although most pumps have a preset KVO Rate in the range 1 to 5 ml hr Some infusion devices e g MedFusion 2001 allow the KVO Rate to be programmed over a restricted range The Dual Rate Test may be used to check the KVO function of an infusion device even though the device may not be capable of piggybacked deliveries In accordance with the Dual Rate Test restrictions ensure the primary delivery rate is at least fives times the KVO Rate of the pump for the switch to KVO operation to be detected For example you could program an infusion device with the following rate schedule and check the device s switch to KVO mode using the Dual Rate Test Infutest will indicate t
52. e upper right hand corner of the test measurement screen The flow status indicator may show LOW or HI if the flow pattern is relatively smooth and continuous PUL if moderately pulsatile flow is detected pulses having volume 0 035 to 0 070 ml typical of Abbott Lifecare 4P and similar pumps or VPF if very pulsatile flow is detected pulses having volume over 0 070 ml typical of enteral feeding Kangaroo pumps Infutest will always assume LOW flow at the start of the test and will if necessary make a change after 0 2 to 1 2 mlhas been delivered In some instances the flow status indicator may intermittently read IFL interrupted flow when running a LOW flow test This is an indication that the pump under test has generally continuous flow with intermittent pauses in flow This is typical of some linear peristaltic pumps which have a pause in their flow pattern when the pump mechanism reaches the bottom of its travel and recycles to the top e g Baxter FloGard 6201 Sigma 6000 Test UsagelChapter 5 Page 60 INFUTEST 2000 OPERATING MANUAL The Single Rate Test also incorporates a software algorithm called SynchroStart When you start the Single Rate Test SynchroStart places Infutest on standby until fluid flow is actually detected from the device under test DUT As flow from the DUT is detected SynchroStart automatically initializes the flow and volume measurements In an AutoSequence SynchroStart also prevents the INF
53. ended 21 gauge flow restrictor three way stop cock and extension set to the Channel A fluid input Figure 1 Figure 4 Similarly connect the second input tubing set to Channel B This arrangement is recommended for proper instrument operation Connect the output extension set to the Channel A amp B common output Figure 2 Figure 7 The A amp B Output should drain into a collection vessel of appropriate volume ideally located on the bench near the Infutest A small 250 to 500 ml beaker will suffice for most test situations The collection vessel should not be located more than 36 below the level of the A amp B Output This will prevent a vacuum from being applied to the Infutest which could damage the internal pressure sensors or cause a pressure zero error when the Infutest is powered up Refer to the instructions in Appendix A if a Back Pressure is to be applied to the Infutest to oppose the flow from the infusion device Set up Chapter 3 Page 17 INFUTEST 2000 OPERATING MANUAL 3 2 Priming Figure 4 Figure 5and Figure on the following page show the three possible positions of the stop cock connected to a channel input As illustrated the three positions are referred to as ON PRIME or FLUSH and OFF CHANNEL ON FROM PUMP INFUTEST 2000E CHANNEL INPUT 0000 F 21 gauge flow re
54. entually drain out the open input Although this will cause no damage to the Infutest the resulting drainage may adversely affect nearby electronic equipment Test UsagelChapter 5 Page 57 INFUTEST 2000 OPERATING MANUAL Do not extend the length of the supplied A amp B Output tubing set by more than 12 30 cm Do not restrict the output tubing set or extend it with narrow gauge IV tubing Follow the instructions in Appendix A when applying a back pressure to the A amp B Output Do not attempt to verity calibration of the Infutest by connecting the A amp B Output to a burette or other volumetric or gravimetric measuring device The output of Infutest s two flow channels are combined in an internal reservoir or collection tank before draining via the A amp B Output port see Appendix B Operational Overview The tank is filled mostly with air when the pressure applied to the A amp B Output is near zero Therefore the flow of test fluid into the Infutest and the exit of test fluid from the A amp B Output are poorly related except in a gross sense You should ensure no fluid pressure is applied to the Infutest s inputs or output when you first turn the instrument on This is important because Infutest attempts to zero the offset of its pressure transducers as part of an internal self test Remember if you allow gravity free flow through a pump from an IV bag to the Infutest you will be applying a pressure to the Infutest by virtue of
55. equences 15 5 6 3 Adding the Occlusion Test to Sequences 75 5 7 Understanding Your Test Results osc ces cod eek ee deen a 77 6 REMOTE CONTROL E Qn e She ecru ie Y ew d 81 6 TL OVEIMMOW RADEON RAK QU RETRO EMR A dn 81 6 2 GONNCCHONS Aino nae Macc te Waban es RR Mata eae 82 6 3 Command Syntax ei btn Ce ces ete d EMI LM M rco M ie El 82 6 4 Command Types and Return Values 83 6 5 Command Lists o iore Soa eb ane quede eru was e eins 84 Table of Contents Page vi INFUTEST 2000 OPERATING MANUAL 6 6 Command Descriptions oot erede Sua epee oe ee ee Oe bee ee 84 6 6 1 Test Control Commands RUN TEST 84 6 6 2 Test Control Commands RUN AUTOSEQUENCE 85 6 6 3 Test Control Commands STOP TEST ABORT AUTOSEQUENCE 86 6 6 4 Report Output Control PRINT REPORT 86 6 6 5 Report Output Control DOWNLOAD REPORT 86 6 6 6 Get Data Commands GET TEST SUMMARY 87 6 6 7 Get Data Commands GET REAL TIME DATA 88 6 7 Programming Examples ER FERE HESS 90 6 7 1 QBasic Programming 224 02 uses hon t tech Que Kit RR 90 6 7 2 medTester Programming 0 000 eee ees 99 APP
56. equency is not covered under the warranty During the warranty period DSI will at our option either repair or replace a product at no charge that proves to be defective provided you return the product shipping duty brokerage and taxes prepaid to DSI Any and all transportation charges incurred are the responsibility of the purchaser and are not included within this warranty This warranty extends only to the original purchaser and does not cover damage from abuse neglect accident or misuse or as the result of service or modification by other than DSI INNO EVENT SHALL DATREND SYSTEMS INC BE LIABLE FOR CONSEQUENTIAL DAMAGES No warranty shall apply when damage is caused by any of the following Introduction of fluids not specified in the instruction manual Application of excessive pressure or vacuum suction to the device inputs Failure to rinse or clear the fluid flow path as instructed in the manual Power failure surges or spikes Damage in transit or when moving the instrument Improper power supply such as low voltage incorrect voltage defective wiring or inadequate fuses Accident alteration abuse or misuse of the instrument Fire water damage theft war riot hostility acts of God such as hurricanes floods etc Only serialized products those items bearing a distinct serial number tag and their accessory items are covered under this warranty PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER
57. er 4 minutes at 200 ml hr Calculate the average rate in ml hr by dividing the mass by the specific gravity 0 9973 gm ml at 24 C and then by the test time Compare this result to Infutest s Average Flow from a Single Rate Test of 10 minute 50 ml hr or 4 minute 200 ml hr duration Three runs consisting of a gravimetric measurement followed by the Infutest Single Rate Test should be conducted to obtain repeatability of both the standard gravimetric and the Infutest Appendix C 110
58. ercent error calculation has been enabled on the Infutest channel a percent error value will be displayed to the right of the Average Rate see Section 4 2 paragraph f Back is the back pressure measured at the end of the test in mmHg Pressure Operation Chapter 4 36 INFUTEST 2000 OPERATING MANUAL The SUMMARY screen shown in Figure 16 is from an AutoSequence with an Occlusion Pressure test enabled In this case pressing the OCCL PR key displays the summary for the Occlusion Pressure test see Section 4 6 4 For manually run Single Rate Dual Rate or PCA pump tests or if the occlusion test is not enabled in the AutoSequence the OCCL PR key is labelled DATA Pressing the DATA key displays the contents of the data log 4 6 2 SUMMARY Screen for Dual Rate Test The SUMMARY screen for a Dual Rate Test is shown in Figure 17 SUMMARY CHAN B Jan 10 10 21 DUAL RATE TEST RATE 1 RATE 2 Back Pr Inf Time 00 02 08 00 01 26 1 mmHg Vol Inf 1 604 ml 0 116 ml Avg Rate 45 09 ml h 4 905 ml h OUTPUT CHANNEL DATA START Figure 17 SUMMARY screen for Dual Rate Test Channel As with the Single Rate Test if an Occlusion Pressure Test is started by an AutoSequence the DATA soft key will be replaced by OCCL PR Pressing the OCCL PR key will access the pressure summary screen If the user chooses to stop a Dual Rate Test before the infusion device switches to Rate 2 no values will appear on the right ha
59. est detects that the infusion device produces pulsatile flow a WARNING message will be displayed on the test measurement screen and the flow status indicator will flash PUL The PCA Pump Test will still detect bolus deliveries and lockout intervals even if the WARNING message is activated However flow and volume measurements displayed on screen may be erroneously LOW Test UsagelChapter 5 Page 70 INFUTEST 2000E OPERATING MANUAL 5 5 Occlusion Pressure Test 5 5 1 Measuring Occlusion Pressure Use the Occlusion Pressure Test to determine the maximum pressure generated by an infusion device when its output is occluded Set the infusion device to produce a suitable flow rate e g 50 to 100 ml hr and start the device pumping Starting the Occlusion Pressure Test will cause the channel to be occluded by an internal valve and the pressure at the input to be sampled and displayed once every two seconds If the infusion device is operating properly the displayed pressure will increase until the device detects the occlusion stops pumping and produces an alarm After this point the displayed pressure will remain approximately constant or may decrease slightly The pressure at which the device produces the alarm is the occlusion pressure If the test is terminated by the test timer or terminated with the STOP key the Summary will report the maximum pressure reading from the test If the Nurse Call is activated during the occlusion press
60. flow data in the Data Log by overwriting the oldest data that is the data which was first acquired at the start of the test This will continue until the user stops the test The Data Log therefore retains the most recently acquired 900 flow measurements Similarly the most recent 700 pressure measurements will be maintained in the pressure Data Log For longer tests of more than 900 measurements the Infutest provides real time data output through the use of the computer interfacing commands IRC In this case all measurements obtained may be sent both to the Data Log and to the Serial Port 4 7 2 DATA Screen Usage Pressing the DATA soft key of the SUMMARY screen will cause the channel s Data Log to be displayed in tabular format as shown in Figure 20 The DATA screen allows the user to scroll line by line through the contents of the channel s Data Log The XX XX illustrated in the example of Figure 20 represent arbitrary numerical data OperationIlChapter 4 Page 40 INFUTEST 2000 OPERATING MANUAL CHAN A Flow Avg Flow Volume ml h ml h anl SCROLL SCROLL Figure 20 Data table for Single Rate Dual Rate and PCA Pump Tests no event markers a Press the SCROLL soft key to scroll forward through the Data Log line by line If the key is pressed and held the data will continuously scroll until the key is released b Press the SCROLL soft key to scroll backward through the Data L
61. fluid should be colourless and should not contain visible particulate matter An agent for reducing surface tension of the test fluid 15 normally not required for routine use However wetting agent such as Jet Dry may be added if required In the case of Jet Dry a concentration of 1 0 ml per litre of test fluid is recommended as a starting point Wetting agent concentration may have to be varied depending the purity of the test fluid IMPORTANT THE USE OF SALINE SOLUTION AS A TEST FLUID IS STRONGLY DISCOURAGED AND WILL VOID THE WARRANTY IN THE EVENT SALINE SOLUTION IS ACCIDENTALLY USED THE INFUTEST SHOULD BE FLUSHED WITH DISTILLED WATER DO NOT USE DEXTROSE IN WATER eg D5W D25W OR OTHER VISCOUS TEST FLUIDS WITH THE INFUTEST USE OF SUCH FLUIDS WILL VOID THE WARRANTY If the instrument is in daily use both channels should be kept primed between tests provided that distilled water or low hardness domestic water 15 employed If the instrument is to be stored for several months or transported fluid should be drained from the unit by forcing air into each channel input with a large syringe while the alternate input is blocked The instrument should then be carefully blown out from the A and B inputs to the common output using clean dry compressed air For the remainder of this manual the test fluid is assumed to be distilled water ot low hardness domestic water and is referred to generically as water Overview Chapter 2
62. g at the input while the output is blocked Remove the cause of the pressure or vacuum and re power the unit If the Infutest is left in a partially primed state e g the glass and tubing are filled with sections of air and small columns of water simply connecting then disconnecting a collection vessel to the O P may result in enough pressure being applied then stored in the system to cause a fault when the unit is powered on and the self test is performed There are two methods for clearing the fault and removing the pressure One method is to release the pressure by opening the I P shutoff valve This can be accomplished by connecting the appropriate coupling to the shut off valve thus releasing the pressure The applied coupling may not be connected to an Infusion pump or any other device it must be open to atmosphere The second method is to prime the unit and then remove any connections to the I P and O P couplings In either case re power the unit FAULT TCO SCI Serial Communications Error When unit power is rapidly cycled on and off this message may be displayed on some units Shut the unit off for a minimum of 30 seconds before attempting to power up the unit If the error persists contact Datrend Customer Service with the unit serial number for further instructions Operation Chapter 4 Page 48 INFUTEST 2000 OPERATING MANUAL 4 10 AutoSequences To assist in standardizing test protocols the Infutes
63. h cold water drawn directly from the tap Infutest is calibrated using distilled water as the test fluid For this reason you should also use distilled water as the test fluid if you want to get maximum accuracy from your Infutest Distilled water may be left in the Infutest for months or even years without damaging the internal sensors or causing rusting of the valves Test UsagelChapter 5 Page 53 INFUTEST 2000 OPERATING MANUAL b Use tap water with caution Water drawn from the cold faucet is an acceptable test fluid provided it is soft low mineral content clean and perfectly clear Do not use water from the hot tap as foreign material from your building s water heater may damage the Infutest s flow sensors Tap water that s been left open to air may collect dust and dirt and may even grow algae if exposed to sunlight To maintain cleanliness tap water should be kept in an enclosed vessel and should be replaced daily If you use water from the tap collect the cold water in a clean container and leave it for a few hours to de gas and warm up to room temperature It is also good practice to pass tap water through a domestic water filter before use for example a Brita filter c DON T use coloured water The Infutest s flow sensors incorporate optoelectronics which are calibrated to detect transparent i e distilled water Using water mixed with food dye or other colouring may cause Infutest to display erroneous f
64. h from RATE 1 to RATE 2 will not be detected Flow and volume measurements may be low see Section 5 3 5 BOLUS NNN The triggered delivery of bolus number NNN from the PCA pump is in progress or has been completed NNN 1 to 255 After delivery the average delivery rate and the volume of the bolus are posted beside the Avg and Vol labels respectively WARNING PUL the infusion device produces pulsatile flow Flow and volume measurements may be low see Section 5 4 3 MM SS flow status indicator Lockout The lockout time between bolus deliveries number NNN and number NNN 1 measured in mm ss minutes and seconds The screen shown in Figure 1415 for an AutoSequence test with an occlusion pressure test enabled In a manually selected test or if the pressure test has not been enabled in the AutoSequence the OCCL PR soft key will read STOP To operate the Infutest proceed as follows when viewing the TEST screen a Press the RESTART soft key to cause the test or AutoSequence to abort and return to the START screen Press the CHANNEL soft key to cause a Channel B screen to be displayed if the channel is not running a test the Channel B STARTscreen will appear allowing the user to set up and start a test on Channel B see Section 4 2 Setting Up a Tesh Press the STOP soft key to cause the test to stop running and the SUMMARY screen to be displayed or if the OCCL PR soft key is displayed press it
65. he KVO delivery as RATE 2 Flow Rate or Infusion Dose KVO RATE 2 5 ml hr N A Remember to start the Dual Rate Test first and then the infusion device so that the actual volume infused at RATE 1 is measured accurately After the infusion device switches to KVO operation allow the test to continue for at least few minutes so that an accurate measure of the average KVO Rate is obtained The DUT s KVO alarm indicator will usually continue to sound and must be ignored for the duration of the KVO rate measurement 5 3 4 Testing Bolus Plus Basal Mode Operation Some Patient Controlled Analgesia PCA pumps are capable of infusing a preset Bolus volume while simultaneously delivering medication at a background Basal flow rate The Dual Rate Test may be used to evaluate this feature Refer to the PCA pump manufacturer s manuals regarding Basal delivery Test UsagelChapter 5 Page 66 INFUTEST 2000 OPERATING MANUAL Set the Basal Rate equal to or less than one fifth the Bolus delivery rate of the PCA pump If the Bolus delivery rate of the pump is unknown try a Basal Rate of 10 ml hr Program the pump to deliver a suitable Bolus Volume e g 2 ml and start the device pumping at the Basal rate Set up the Infutest for a Dual Rate Test Start the Dual Rate Test then at the same time trigger the PCA Pump manually with the patient s medication delivery switch After Bolus delivery leave the pump running at the Basal ra
66. ices Am J Hosp Pharm vol 45 pp 361 5 Feb 1988 Auty B Equipment for intravenous infusion some aspects of performance Agressologie vol 29 12 824 828 1988 Tam Y Automated performance checking of infusion equipment C Phys and Physiol Meas vol 10 pp 311 318 1989 Infutest s Average Flow is a cumulative measurement of the total volume delivered from the pump divided by the total time taken to deliver it All medical infusion devices will produce a stable Average Flow reading i e a horizontal line on Infutest s AVG graph if given enough time Infutest s instantaneous flow reading and FLOW graph however will be highly dependent on the functional type manufacturer and model of pump being tested Test UsagelChapter 5 Page 77 INFUTEST 2000E OPERATING MANUAL Syringe pumps e g AutoSyringe 5205 Bard 150 XL MedFusion 2001 may exhibit a startup characteristic in which flow is initially low and then gradually increases to the set rate as slack in the lead screw mechanism 15 taken up Syringe pumps may also produce erratic flow if the syringe has been re used so often that its internal lubricant has worn off Such anomalies may be avoided however by installing a new syringe and allowing the pump to run for several minutes before testing Linear peristaltic pumps e g Baxter 6200 Sigma 6000 tend to be mote erratic in their instantaneous flow at lower rates you will normally see large peaks and
67. ied channel Format STi chan chan A B C or D Examples STA stop test AutoSequence on channel A STC stop test AutoSequence on channel C RSM Only Returns Acknowledged test may be stopped Syntax error e Error no test currently running on channel n Channel specified does not exist 6 6 4 Report Output Control PRINT REPORT Places a print job in the report output queue Format PRI chan parm chan A B C or D parm 1 for Summary Report 2 for Data Log Report Examples PRA1 put channel A Summary report in output queue print PRD2 put channel D Data Log in output queue print RSM only Returns Acknowledged job placed in queue Syntax error n Channel specified does not exist 6 6 5 Report Output Control DOWNLOAD REPORT Remote ControllChapter 6 Page 86 INFUTEST 2000 OPERATING MANUAL Places a serial download job in the report output queue Format DL chan parm chan A B C D parm 1 for Summary Report 2 for Data Log Report Examples DLA1 put channel A Summary report in output queue serial DLD1 put channel D Summary report in output queue seriall RSM only Returns Syntax error n Channel specified does not exist Otherwise Summary or Data Log report up to 60 000 bytes 6 6 6 Get Data Commands GET TEST SUMMARY Returns summarized test results as a string of up to 34 ASCII characters terminated by a catriage return after a test has been stopped or a prese
68. indicator one of LOW HI 2 PUL VPF LOCKOUT SINGLE RATE Time 00 01 35 Flow 23 31 ml h Avg 25 41 ml h Vol 0 671 ml Back Pr 3 mmHg 15 AVG FLOW OCCL PR RESTART Figure 14 TEST screen for Single Rate Test Channel A The definitions of the displayed mnemonics on the left half of the screen are Time is the total time elapsed since the start of the test in hours minutes and seconds hh mm ss For Single Rate Dual Rate and PCA Pump Tests Flow Avg Vol Back Pr is the instantaneous flow rate in milliliters per hour obtained by measuring a small volume of effused test fluid over a fixed interval of time ranging from a minimum of 4 seconds to a maximum of approximately 10 minutes is the average flow rate from the start of the test in milliliters per hour derived by calculating the ratio of the total effused volume to the total elapsed time is the total volume of fluid which has been effused through since the test was started in milliliters is the back pressure in mmHg appearing at the input which is approximately equal to the positive pressure optionally applied by the user at the Infutest A amp B Output to oppose the flow from the infusion device see Appendix A Back Pressure Testing Operation Chapter 4 33 INFUTEST 2000 OPERATING MANUAL For the Occlusion Pressure Test the TEST screen will appear as in Figure 15 OCC
69. ists of a single printed page Test UsagelChapter 5 Page 74 INFUTEST 2000 OPERATING MANUAL Ifthe OUTPUT TO port of a default AutoSequence is changed to Serial the Infutest should be connected to COM port on the receiving device i e the PC ptior to starting the sequence The PC should be running a terminal emulation program e g Windows Hyperterminal or Datrend s DTP software which will save the down loaded test report to disk when the report 1s transmitted from Infutest at the end of the AutoSequence Refer to Section 3 3 for the necessary interface connections Verify the Rate and VTBI dose settings for the DUT are programmed as defined in TABLE II Before running the DUT clear the DUT s Total Volume Infused display Most infusion devices provide a separate button on the front panel which will reset the Total Volume Infused Flush the Infutest Start the selected AutoSequence first and then start the pump This will activate Infutest s SynchroStart feature so the actual volume infused by the DUT is measured by the end of the rate test which may then be compared to the acceptance range for delivered volume published in the manufacturer s Service Manual for the DUT 5 6 2 Reloading Default Test Sequences If you make changes to the factory default AutoSequences and wish to restore the original settings power up the Infutest while holding down the front panel key second from the left Infutest will prompt you to repr
70. l mmHg hh mm ss XX XX XX XX X XXX X END OF LOG SCROLL SCROLL Figure 23 Data table showing the end of the Data Log has been reached OperationIlChapter 4 42 INFUTEST 2000 OPERATING MANUAL 4 8 Output of Summary and Data Logs Pressing the OUTPUT soft key on a channel s SUMMARY screen causes the OUTPUT submenu for the channel to be displayed Figure 24 This submenu is used for sending the Summary and or Data Log to either the parallel Printer Port or the Serial Port or both if desired a To set the type of report to be output press the SELECT key until the gt prompt is pointing to REPORT Press MODIFY to change the report type to Summary Data Log or Port Tst OUTPUT CHAN A REPORT Summary lt ID TYPE Contrl No PORT Printer PUMP ID ECN1234567 STATUS READY SUMMARY MODIFY SELECT Figure 24 OUTPUT submenu With REPORT set to Summary a Test Summary Report which will list the contents of the Summary Log will be output to the selected PORT If REPORT is set to Data Log the entire contents of the Data Log up to 2000 lines of measurement data will be output to the selected PORT If REPORT is set to Port Tst two lines of characters will be sent to the selected PORT allowing the user to ensure the receiving device is on line and functioning as expected Press SELECT so that the prompt moves to the PORT parameter Press MODIFY to se
71. lChapter 5 Page 76 INFUTEST 2000E OPERATING MANUAL 5 7 Understanding Your Test Results Infutest measures Instantaneous Flow Average Flow and Infused Volume Of these Average Flow and Infused Volume are the most important because it is these measures which the pump manufacturers use in specifying the accuracy of theirt ptoducts At this time manufacturers do not specify pump performance in terms of instantaneous flow However Infutest s ability to measure instantaneous flow and Infutest s FLOW graph display may be useful in comparing the quality of fluid delivery of pumps of differing makes and models Infutest measures instantaneous flow by observing the volume delivered from a pump over relatively short time intervals These time intervals nominally range from 4 to 20 seconds the exact interval depending on the rate The majority of medical infusion devices do not produce steady flow when the volume delivered is measured over such short time intervals This fact has been previously described in the scientific literature For example refer to the test results and graphs in Stull et al Flow rate variability from electronic infusion devices Crit Care Medicine vol 16 pp 888 891 1988 Farrington Flow rate variability from selected syringe and mobile infusion pumps Drug Intellegence and Clin Pharm Vol 22 pp 687 690 Sept 1988 Leff et al Accuracy continuity and pattern of flow from five macrorate infusion dev
72. lect either Printer or Serial as the output destination If the selected PORT is not already busy outputting data the STATUS line will indicate READY as shown in Figure 24 c Press SELECT so that the prompt moves to the TYPE parameter Press MODIFY to select either Control No Serial No or None as the pump ID TYPE The I D TYPE refers to the pump being tested and allows the user to enter either the serial number or control number of the pump on the PUMP ID line If the ID TYPE is set to Control No Serial No the PUMP ID Operation Chapter 4 Page 43 INFUTEST 2000 OPERATING MANUAL will appear in the appropriate area of the report when the Summary or Data Log is printed or downloaded from the Infutest If there is no desire to include a pump serial number or control number in the report document press MODIFY to set the ID TYPE to None d If ID TYPE has been set to either Control No or Serial No press SELECT so that the gt prompt moves to the PUMP ID parameter Press MODIFY to edit the displayed PUMP ID The keys will change to the editing keys of Figure 25 allowing each character of the PUMP ID to be changed individually Up to 10 characters may be input using SET and SET Note that SET and SET may be held down to continuously scroll through the character set Once editing is complete press ENTER to save the PUMP ID in
73. led To test Bolus Plus Basal mode delivery use the Dual Rate Test as described in Section 5 3 4 Some PCA Pumps do not provide an electrical trigger input suitable for connection to Infutest s PCA trigger output Ambulatory PCA Pumps may have only a front panel push button which is pressed to deliver a bolus Other PCA Pumps may have a pneumatically based trigger switch Such PCA pumps may be tested manually using the real time display of the lockout posted on the test measurement screen as a prompt Test UsagelChapter 5 Page 69 INFUTEST 2000 OPERATING MANUAL For manual PCA Pump testing the lockout interval of the pump is presumed to be preset to an integer number of minutes e g 5 0 minutes During the lockout period Infutest will produce an audio alert tone every time the seconds indicator of the lockout time display passes 45 seconds The audio alert is meant to signal the user to manually activate the trigger button on the PCA pump as the end of the preset lockout approaches The PCA Pump should be repeatedly triggered about once per second after Infutest produces an alert tone which is close to the preset lockout time until the pump actually begins to deliver a bolus At the start of a bolus delivery the Infutest trigger relay will stop and the state of the test measurement screen will change 5 4 3 PCA Pump PULSATILE Warning The PCA Pump Test is suitable for use only with continuous flow infusion devices If Infut
74. lf of the SUMMARY screen 4 6 3 SUMMARY Screen for PCA Pump Test The SUMMARY screen for a PCA Pump Test is shown in Figure 18 The data displayed are averages calculated from the individual values of each of the respective measurements from the beginning of the test If a appears at the end of the Average Bolus Volume line this indicates that one or more individual bolus volumes has exceeded the first measured bolus by 10 Similarly a on the Average Lockout Time line indicates a variation in excess of 10 in the measured lockout times with the first lockout time used as a reference To review the complete data for the test press the DATA soft key to access the complete log of measurement data Operation Chapter 4 Page 37 INFUTEST 2000 OPERATING MANUAL SUMMARY CHAN A Jan 10 10 29 P C A PUMP TEST Average Bolus Volume 1 438 ml 1 Average Delivery Rate 92 68 ml h Average Lockout Time 05 02 mm ss Number of Deliveries 3 OUTPUT CHANNEL DATA START Figure 18 SUMMARY screen for PCA Pump Test Channel A The Number of Deliveries refers to the number of complete bolus deliveries If a test is STOPped during a lockout time measurement the Number of Deliveries will include the last bolus measured 4 6 4 SUMMARY Screen for Occlusion Pressure Test The SUMMARY screen for an Occlusion Pressure Test initially selected on the SETUP menu or executed as part of an Au
75. low and volume measurements Dyes may also stain the tubing and fittings of Infutest s internal fluid system which will void the warranty d DON T use saline You may use normal saline e g 0 9 Sodium Chloride Injection USP if you must but you may damage the Infutest if you don t flush out the fluid channel thoroughly with distilled water immediately after testing the pump Never use saline to test a pump and then leave the saline in the instrument or simply drain the Infutest and store the instrument away on the shelf Since Infutest s occluder valves are made of magnetic stainless steel exposure to both salt water droplets and oxygen will eventually cause the valves to rust At this point you will find you can t prime the Infutest or you can t perform the Occlusion Pressure Test Damage to the Infutest s valves from use of saline as a test fluid is not covered under warranty Test UsagelChapter 5 Page 54 INFUTEST 2000 OPERATING MANUAL DON T use D5W D25W D50W The Infutest s flow sensors are designed and calibrated to work with distilled water D5W D25W and similar dextrose solutions in addition to being too viscous leave a sticky residue in the glass tubes of the flow sensors which prevents proper operation Never allow dextrose TPN solution to get into the Infutest If you do Infutest will probably display erratic and or erroneously low measurements You will then have to clean the sticky material ou
76. m be applied to the A amp B Output as this may damage the internal pressure sensor d Water may be pumped out of the flask into the Infutest s A amp B Output during pressurization of the apparatus If this happens reprime the Infutest once the apparatus has been pressurized so that the tubing connecting the A amp B Output to the flask is completely filled with water e Prepare the DUT then set up and start a Single Rate Dual Rate or PCA Pump Test see Sections 4 2 4 3 The back pressure applied to the DUT will be measured displayed on the TEST screen and stored in the Data and Summary logs along with the measured flow and volume data f The back pressure should not be allowed to change for the duration of the test IV tubing is compliant and an increase in back pressure may cause a drop in measured flow and volume simply because the IV tubing is being stretched by the increased pressure in the system Variations in device performance may therefore be more an effect of the tubing than of the device itself Appendix A 103 INFUTEST 2000 OPERATING MANUAL Appendix Page 104 INFUTEST 2000 OPERATING MANUAL Appendix APPENDIX B OPERATIONAL OVERVIEW B 1 General Description Figure 34 is a block diagram showing the major assemblies of the Infutest Test fluid flows from the Channel A and B inputs to the Sensor Chassis where the flow sensing system comprising two flow sensors and a nu
77. mber of solenoid valves is located Channel pressure is measured via a transducer connected at each input via a tee Fluid exiting the flow sensor on the Sensor Chassis is combined in a collection tank which drains out the A amp B Output Analog signals from the flow and pressure sensors are A D converted and analyzed by the Test Controller TCO which also outputs valve control signals to the Sensor Chassis 16 bit CPU of the TCO interacts with the sensors and valves executing software algorithms SynchroStart flow pattern analysis Single Rate Test etc which perform the actual measurements Calibration data for the flow and pressure sensors are stored in a 512 byte EEPROM located on the TCO Calibration of the Infutest is completely software based there are no manual adjustments or controls inside the unit Measurement data obtained by the TCO is serially transmitted to the Display Unit for display to the user The Display Unit is based on an 8 bit CPU which operates the LCD keypad printer serial and AUX interface ports The Display Unit includes a real time clock and a 32K RAM where measurement data from the TCO are stored the data log Contents of the 32K RAM are preserved by a 3 V lithium battery in the Display Unit when the Infutest is powered down After powering up the Infutest the LCD will display two software version numbers following a successful self test The versions are displayed as IFT TCO where is th
78. n PRINT AUTOSEQUENCE DOWNLOADER PRINT PRINT Flush Infutest Channel A PRINT Press any key to proceed or lt ESC gt to abort now Wait here for user to press a key DO C INKEYS LOOP WHILE C IF C lt gt CHR 27 THEN PRINT INPUT Enter file name for storage of test report filename PRINT PRINT 1 RSA1 Send START command to Infutest Chan A AutoSequence 1 INPUT 1 IFTdata Get Infutest s response PRINT AutoSequence 1 started PRINT Start infusion pump running anytime Remote ControllChapter 6 Page 95 INFUTEST 2000 OPERATING MANUAL Example 3 Serial download trom AutoSequence cont d SERIAL DATA DOWNLOAD Substitute APPEND for OUTPUT if you want the data appended to the end of an existing file OPEN filename FOR OUTPUT AS 2 Open the file for the test report If you are not interested in AutoSequences you can use a loop like this to download test data collected during ordinary Single Rate Dual Rate PCA Pump or Occlusion Pressure tests Just precede this DO loop by the statement PRINT 1 DLA1 for the summary or PRINT 1 DLA2 for the data log DO IFTdata INPUT 1 1 Wait here for a character from Infutest PRINT 2 IFTdata Print character to file Echo character to screen When printing to the screen Qbasic translates newline to carriage return and blanks the screen for formfeed characters This IF statement
79. nimum restocking fee of 20 Additional charges for damage and or missing parts and accessories will be applied to all returns Products which are not in as new and resalable condition are not eligible for credit return and will be returned to the customer at their expense Certification This instrument was thoroughly tested and inspected and found to meet DSI s manufacturing specifications when it was shipped from the factory Calibration measurements are traceable to the National Research Council of Canada NRC and or the National Institute of Standards and Technology NIST Devices for which there are no NRC NIST calibration standards are measured against in house performance standards using accepted test procedures Page i Warranty Datrend Systems Inc DSI warrants this instrument to be free from defects in materials and workmanship under normal use and service for one 1 year from the date of original purchase This warranty will be automatically extended to a maximum of five 5 years from the date of original purchase provided that calibration is performed on an annual basis by a Datrend Authorized Service Center refer to Appendix C of this manual This warranty is subject to the following limitations Occluder Valves 1 year limited warranty e Pressure Transducers 1 year limited warranty Standard Accessories 90 day limited warranty e Re calibration of the instrument which has a recommended annual calibration fr
80. o which disables the autosequences Press the MODIFY key to change the setting Operation Chapter 4 Page 49 INFUTEST 2000 OPERATING MANUAL MFR The pump manufacturer s name may be keyed into this space or any other prompt you wish The MFR parameter is seven characters long and may be changed by pressing the MODIFY key when the arrow lt points to the MFR line On entering the text editor the display of Figure 30 will appear with the first character of the text highlighted To change the highlighted character press SET or SET to scroll through the available character set If the key remains pressed the scroll will be continuous until it is released When the correct character is found press SELECT to move to the next character When all the characters have been selected press ENTER to return to the main sequence editing screen MOD The model of the pump may be optionally inserted or edited when the arrow points to this parameter The MOD parameter is seven characters long and is edited as described in the MFR section AutoSequence 1 ENABLED Yes RATE TEST Single MFR ABBOTT lt INF TIMER 90 sec MOD PLUM XL OCCL TEST off REMARK AUTO OUTPUT Summary Set pmp rate OUTPUT PORT Printer ENTER SET SET SELECT Figure 30 Text editing screen REMARK The remark entry consists of 24 characters and is generally a user prompt which will appear on the test START screen It is intended a
81. o nine 9 automated test sequences Refer to section 4 10 for complete instructions on the setup and use of automated sequence testing or h Press the START soft key to set up and start a new test i Press the UTILITY key to display the screen of Figure 9 which allows setting of the internal time date clock or entry of a user defined test equipment identification number for the Infutest UTILITY gt DATE Jun 01 2005 TIME 09 36 FORMAT USA ID No EDC05080651 MODIFY SELECT Figure 9 UTILITY screen OperationIChapter 4 Page 26 INFUTEST 2000 OPERATING MANUAL j To set the date press the SELECT key until the gt prompt is pointing to DATE Press MODIFY to change the DATE The editing keys of Figure 10 will then appear at the bottom of the screen ENTER SET SET SELECT Figure 10 DATE TIME and ID No editing keys k Press SELECT to move the editing cursor between the month day and year displayed on the screen Press SET to increment the highlighted item or SET to decrement the highlighted item SET and SET may be held down to continuously increment or decrement the selected item Press ENTER to input the displayed DATE into the Infutest clock The clock will support all dates for years 1999 through 2098 including Feb 29 of leap years l Press SELECT to move the prompt to the TIME displayed on the screen Press MODIFY to change the TIME The editing keys of Figu
82. og line by line If the key is pressed and held the data will continuously scroll until the key is released c Press the SUMMARY soft key to return to the SUMMARY screen d While scrolling through the log with the SCROLL and SCROLL soft keys event markers will appear in line with the numerical data for the Dual Rate PCA Pump and Occlusion Pressure Tests Refer to Figure 21 for an example of BOLUS and LOCKOUT event markers which are inserted into the Data Log of the PCA Pump Test DATA CHAN A Elapsed Flow Avg Flow Volume Time ml h ml h ml mmHg hh mm ss XX XX XX XX X XXX X LOCKOUT TIME 06 01 BEGIN BOLUS 2 hh mm ss XXX X XXX X X XXX X SUMMARY SCROLL SCROLL Figure 21 Data table for PCA Pump Test showing BOLUS and LOCKOUTTIME event markers 4 41 INFUTEST 2000 OPERATING MANUAL e Ifan Occlusion Pressure Test was conducted manually or as part of an AutoSequence the DATA screen will appear as shown in Figure 22 DATA CHAN A Elapsed Time Occlusion Pressure psi mmHg 00 00 0 0 0 00 00 5 00 00 10 00 00 15 SUMMARY SCROLL SCROLL Figure 22 Data table showing Occlusion Pressure Test data f When the DATA screen has been scrolled to the end of the Data Log the END OF LOG message will be displayed as shown in Figure 23 DATA CHAN A Elapsed Flow Avg Flow Volume B Pres Time ml h ml h m
83. ogram the AutoSequences with factoty default settings 9 AutoSequences will be reprogrammed with factory defaults if you enter YES 5 6 3 Adding the Occlusion Test to Sequences Most pumps sample their internal pressure signal at a relatively slow rate If the Occlusion Pressure Test is run with the pump set at too high a rate it is quite likely that the actual occlusion pressure will be higher than the maximum specified by the manufacturer Because of this pump limitation Occlusion Pressure Tests are best conducted with the pump rate set between 50 and 100 ml hr see Section 5 5 Occlusion Pressure Test The manufacturer specified test flow rates may be too high to conduct an Occlusion Pressure Test However the Occlusion Pressure Test may be added to the default AutoSequences if the pumps are programmed to decrease the flow rate at the onset of the pressure test This may be accomplished by programming the pump with a piggyback delivery Test UsagelChapter 5 75 INFUTEST 2000 OPERATING MANUAL Follow these instructions to add an occlusion test to an AutoSequence and then run the sequence a Runa manual Occlusion Pressure Test with the pump set to 50 ml hr to determine the nominal time required for the device to produce an occlusion alarm For the devices listed in the preceding table the required time is expected to be less than 2 minutes b Use the EDIT SEQ screen to program the desired AutoSequence wi
84. olus volume must be at least 0 5 ml iv flow must be zero during the lockout period The PCA Pump Test requires a cable to connect a trigger output on the Infutest rear panel Figure 3 to the patient control switch input on the PCA pump A of unterminated cables with two insulated conductors plus braided shield is available as an accessory from Datrend Systems PCA 1 A schematic of the unterminated cable is shown in Figure 31 The Infutest PCA trigger incorporates both normally open or normally closed relay contacts which are activated during the PCA Pump Test to simulate the patient actuating the medication delivery switch Connection of the Infutest to the PCA Pump is dependent on the make and model of the pump refer to the manufacturer s technical service manual when preparing a PCA trigger cable When the PCA Pump Test is started the Infutest will activate the trigger relay until flow from the pump is detected Flow and cumulative volume measurements are obtained until the programmed bolus is delivered and flow falls to zero The Infutest detects this condition and begins to time the lockout period simultaneously attempting to trigger the pump to deliver another bolus via its internal trigger relay During the lockout period a timer posted in the upper right corner of the test measurement screen keeps track of the elapsed time of the lockout When flow is detected the trigger relay is stopped and the delivery lockout measurement
85. ominal effective collection volume 0 014 ml Volume Measurement See 1 1 SINGLE RATE TEST Continuous Flow Measurement Back Pressure Measurement See 1 1 SINGLE RATE TEST Continuous Flow Measurement Elapsed Time Measurement See 1 1 SINGLE RATE TEST Continuous Flow Measurement Lockout Time Measurement a b C Range 0 100 minutes Display format mm ss Accutacy t 2 seconds IntroductionIlChapter 1 Page 4 INFUTEST 2000E OPERATING MANUAL 1 4 Occlusion Pressure Test 1 4 1 Pressure Measurement a Display Units mmHg psi b Range 0 2586 mmHg 0 50 psi c Display resolution 1 mmHg 0 1 psi d Measuring time 2 seconds e Zero offset error 5 mmHg 0 1 psi f Accuracy 1 zero offset error 1 4 2 Nurse Call Detection a Nurse Call signal from pump sampled once per second b Nurse Call signal can be produced by any of relay contacts open collector output TTL output RS 232 level or 20 mA current loop c Nurse Call signal may be in either logical state at start of Occlusion Pressure Test 1 5 Data Logger I Memory Type NVRAM battery backed II Capacity 2 channel 900 flow measurements per channel 700 pressure measurements per channel 4 channel 450 flow measurements per channel 350 pressure measurements per channel III Data Output Directable to printer or serial port following completion of a test or AutoSequence Introduction Chapter 1 Page 5 INFU
86. prevents this from happening IF IFTdata lt gt CHR 10 AND IFTdata lt gt CHR 12 THEN PRINT IFTdata END IF Continue downloading until Infutest sends BELL character LOOP UNTIL IFTdata CHR 7 PRINT Output I m finished sound PLAY O3L8EC END IF Close the data file and turn off COM port CLOSE END Remote ControllChapter 6 Page 96 INFUTEST 2000 OPERATING MANUAL Example 4 Hard Disk Data Logger LOGGER BAS Log Infutest Data to Disk c Datrend Systems Inc 2005 Infutest s data log memory is limited to a maximum of 900 measurements per channel or about 2 hours of testing at 100 ml hr This QBasic program shows you how to convert your PC into a data logger with capacity limited only by the size of your hard disk The program runs a Single Rate Test on Infutest Channel A and uses the Get Real Time commands to retrieve test data from Infutest as it is measured The Single Rate Test is run until the user hits the ESC key LOGGER BAS is a simple program which is ideal for saving the large amount of data produced during overnight tests LOGGER BAS begins with some input prompts allowing the user to enter the pump make model ECN and so on More INPUT statements can be added here to input other info Department Location etc LOGGER BAS creates a new file for your test data or overwrites existing files If you want the test data appended onto a file which already exists in the current working directory u
87. process is repeated The number of boluses delivered the average bolus volume average lockout time and average bolus flow rate is provided in the channel Summary Full details of each bolus delivered is available in the channel Data Log Test UsagelChapter 5 Page 68 INFUTEST 2000 OPERATING MANUAL FROM INFUTEST 2000E PHONO PCA TRIG OUTPUT Pd TO PCA PUMP PATIENT CONTROL INPUT RING P TIP U SHIELD NORMALLY OPEN CONTACTS e LL L NORMALLY CLOSED CONTACTS Figure 31 Schematic of unterminated PCA trigger cable PCA 1 available from Datrend Systems The trigger output is provided by floating relay contacts normally open contacts are available between ring and shield normally closed contacts are available between tip and shield 5 4 2 Test Usage Connect the trigger cable to the trigger output of the Infutest and select the PCA Pump Test via the START screen Program the pump to deliver several boluses the test algorithm works well with bolus volumes of approximately 1 0 to 2 5 ml Programming the lockout time to the minimum setting available on the pump typically 1 to 5 minutes will shorten total testing time while providing adequate verification of lockout operation If the bolus delivery rate is also programmable set it between 25 and 100 ml hr If the PCA pump is capable of producing a Basal Flow ensure the Basal tate is set to zero or that Basal delivery is disab
88. quipped with DOS 5 or a later version power up your PC and then type qbasic at the DOS command prompt QBasic should boot showing the Welcome screen Press to clear the screen or press f to view the QBasic HELP index When typing in the programs be sure to include all punctuation marks which appear in the programs These punctuation marks and so on are critical to proper functioning of the programs However you may delete the rematk lines from the programs if you wish In QBasic remark lines begin with the quote character Each program example must be typed in and then saved as a separate BAS file After you have finished entering one of the following example programs save it by typing aF followed by 5 To run the example connect Infutest to COMI set up the pump and then type aR followed by S To quit QBasic type aF followed by X You can access QBasic s HELP system by typing aH If you need help on a QBasic keyword move the cursor to the first letter of the keyword and then press F1 1 The inclusion of this information with this manual should not be considered in any way to be an endorsement of a Microsoft product 2 The INPUT statement of QBasic version 1 1 supplied with MS DOS version 6 0 may sometimes produce anomalous results on a high speed computer when reading data from Infutest No such problems have been detected with QBasic version 1 0 supplied as part of MS DOS version 5 0 Remote Con
89. r hour iv Keep Vein Open Rate following primary delivery v PCA pump Delivery Rate during bolus infusion ranging from 0 1 up to 170 milliliters per hout vi Bolus Volume delivered by PCA pump vii Number of Boluses delivered from PCA pump up to 255 vii Lockout Time between PCA pump bolus deliveries in minutes and seconds ix pump Basal Rate following bolus delivery using Dual Rate Test x Back Pressure applied to infusion device up to 300 mmHg xi Occlusion Pressure produced by infusion device up to 2586 mmHg 50 psi and xii Status of Nurse Call Alarm from infusion device ON OFF The above measurements are organized into four basic test protocols These test protocols are 2 2 1 Single Rate Test Use the Single Rate Test to evaluate the basic performance of all medical infusion devices The Single Rate Test measures Flow Rate instantaneous and average Effused Volume and Back Pressure In addition to accommodating continuous flow infusion devices the Single Rate test also incorporates automated detection and averaging of pulsatile flow for increased measurement accuracy of bolus discharge and other non continuous pumping devices Overview Chapter 2 13 INFUTEST 2000 OPERATING MANUAL 2 2 2 Dual Rate Test Use the Dual Rate Test to evaluate infusion devices capable of ptimary secondary delivery or delivery piggybacking that is delivery of a first preset volume at a first
90. r to the manufacturer s recommendations with respect to volumetric accuracy testing which should be included in the manufacturer s Service Manual for the DUT If the DUT produces continuous flow e g syringe pump you may start the Single Rate Test either before or after starting the DUT if you are simply checking for basic rate accuracy If the DUT is pulsatile and especially if the DUT is used in enteral feeding or TPN applications e g Kangaroo pump you should start the Infutest first and then start the DUT running after Infutest switches from the START to TEST display This will activate Infutest s SynchroStart feature so that the Single Rate Test is synchronized with the delivery cycle of the DUT Flow pattern recognition is ongoing throughout the Single Rate Test At the start of the test the flow pattern recognition may select PUL or VPF measurement algorithms based on a startup surge or other flow anomaly that the DUT produces when it first starts running If you wish to avoid this start the Single Rate Test after letting the DUT run and stabilize for a few minutes In addition to rate accuracy testing you may also use the Single Rate Test to verify accuracy of the DUT in delivering a preset Volume to Be Infused VTBI Dose Program the DUT with the desired Rate and VT BI Dose Suitable Rate and VTBI settings for this type of test will usually appear in the Service Manual of the DUT under a flow accuracy or volumetric
91. rate followed by delivery of a second preset volume at a second rate The Dual Rate Test measures Flow Rate instantaneous and average Effused Volume and Back Pressure for each delivery programmed into the Dual Rate pump Also use the Dual Rate Test to evaluate Keep Vein Open KVO operation and PCA Bolus Plus Basal mode delivery with infusion devices which incorporate these features 2 2 3 PCA Pump Test Use the PCA Pump Test to evaluate the basic performance of Patient Controlled infusion devices The PCA Pump Test measures Flow Rate instantaneous and average and Bolus Volume for each bolus delivery the Lockout Time between bolus deliveries and the Number of Boluses delivered during the test Back Pressure is also measured 2 2 4 Occlusion Pressure Test Use the Occlusion Pressure Test to measure the maximum pressure generated by an infusion device when its output is occluded Also use the Occlusion Pressure Test to check the operation of the Nurse Call Alarm on pumps which incorporate this feature Overview Chapter 2 Page 14 INFUTEST 2000E OPERATING MANUAL 2 3 Test Fluids The following test fluids are acceptable for use with the Infutest 1 DISTILLED WATER 2 CLEAN DOMESTIC WATER i e tap water Common distilled water is the preferred test fluid If domestic water is employed occasional flushing with distilled water may be required following use depending on hardness and quality of the local water The test
92. ration set when testing an infusion device or at least change the set periodically according to the manufacturer s recommendations Use of IV sets which have or may have been used with saline dextrose or other IV fluids should be avoided See section 2 3 Test Fluids IMPORTANT After powering up Infutest will attempt to obtain a zero pressure reference To avoid a pressure zero alarm ensure no pressure is applied at the Infutest inputs or output when applying power to the unit Install the IV set in the DUT and leave the DUT on standby while the Infutest performs its self test routines to prevent a pressure zero alarm Set up Chapter 3 Page 20 INFUTEST 2000E OPERATING MANUAL IMPORTANT When testing a syringe pump always use a new disposable syringe Prelubricate the syringe by drawing on the plunger a few times before loading the syringe with water and installing it in the pump After priming and connecting the administration set to a channel always flush the channel before starting the test using a technique similar to that described to prime the Infutest Injecting about 5 cc of water should be sufficient to remove any air bubbles in the channel The Infutest reminds the user to do this via the LCD prior to starting a test If a test is already running on one channel flush or prime the other channel by injecting water into it gradually rather than rapidly discharge about 10 cc of water into the channel over 5 se
93. re 10 will appear and will operate in a manner similar to setting the date The clock employs a 24 hour format m Press SELECT to move the prompt to FORMAT on the utility screen Press MODIFY to select one of the three available formats for the clock date as follows USA Month Day Year EUR ope Day Month Year ISO Year Month Day n Press SELECT to move the prompt to ID No on the utility screen For Infutests shipped from the factory the default ID No is the unit serial number If desired press MODIFY to edit the ID number displayed on the screen The keys will change to the editing keys of Figure 10 allowing each character of the ID No to be changed individually Up to 12 characters may be input using SET and SET Once editing is complete press ENTER to save the ID No in memoty The ID No shown on the utility screen is provided as a test equipment identification numbet and as such will appear in each Test Summary or Data Log report printed or downloaded from the Infutest This allows each test document to be traced to the Infutest which produced the document a requirement for ISO 9000 compliant institutions and service providers 4 27 INFUTEST 2000 OPERATING MANUAL o Once the DATE TIME date FORMAT and Infutest ID No have been set as desired press the EXIT key to quit the utility function and return to the power up s
94. ring Up and Setting the Clock Set the Infutest power switch on the rear panel Figure f to ON The Infutest LCD will display a power up screen while performing a number of internal self tests If required adjust the LCD contrast control on the rear panel Figure 3 using a trimpot adjustment tool If an abnormal condition is detected during the power on self test the Infutest will report the fault by means of an alarm tone and message on the display Refer to Section 4 9 Alarms if this should happen Upon successful completion of the self test the screen illustrated in Figure 8 will appear The label displayed above each front panel key corresponds to the function of the key for the currently viewed screen These keys are referred to as soft keys A real time clock appears in the upper right hand corner of the LCD on most menus and screens as shown in Figure 8 The clock has 24 hour format and may be displayed as MONTH DAY hours min USA or DAY MONTH hours min EUR and ISO Operation Chapter 4 25 INFUTEST 2000 OPERATING MANUAL Jun 10 09 35 Datrend Systems Inc INFUTEST 2000 Series E Version 3 7 3 2 LIDSI 2005 START LOGS EDIT SEQ UTILITY Figure 8 Power on screen following successful self test f Press the LOGS soft key to recall previously acquired test results stored in the non volatile Summary and Data Log or g Press the EDIT SEQ soft key to create edit and enable up t
95. roduct warranty The basic one 1 year warranty can be extended to a maximum of five 5 years provided that calibration is performed a Datrend Authorized Service Center on an annual basis The Infutest can only be CALIBRATED with specialized equipment and software found at Datrend authorized service facilities This equipment allows proper adjustment of the internal electronics of the instrument Independent service providers may be able to perform a performance VERIFICATION however they will NOT be able to perform repairs or adjustments to your Infutest Use of an unauthorized facility for service and or calibration will void your warranty When calibration is due contact Datrend Customer Service to determine the authorized service facility nearest your location and to obtain an RMA number In North America 1 800 667 6557 Outside North America 604 291 7747 e Mail customerservice datrend com Appendix C 109 INFUTEST 2000 OPERATING MANUAL C 2 Calibration Verification C 2 1 Pressure Accuracy Verification Field Test Calibration of Infutest s pressure measurement system may be verified in the field by running an Occlusion Pressure Test with an external pressure gauge connected via a tee to the input Validity of the pressure calibration verification will be dependant on the accuracy and traceability of the external gauge used C 2 2 Flow Accuracy Verification Field Test Calibration of the flow measuremen
96. rt Dele ead Walid uota Vc db aas 56 5 1 4 Input and Output Connections 57 5 1 5 Flushing Prior to Test Startup inem ERE 58 5 2 Single Rate Test sete 00654 0045 S45 eee 60 5 2 1 Test Description nes ERA bU 60 522 Test USAC oa ce sud vetu Sr aeta Ea d oue ies 62 5S Dual Bate Test recor vetat o equ ere tee Utt ad dew 64 5 3 1 Testing Piggyback Operation 64 5 3 2 Testing Titrated Rates ss Seu cea RR EE ER EE A 65 5 3 3 Testing KVO Operation 22008 ies See owe Be Bowe BEE ows 66 5 3 4 Testing Bolus Plus Basal Mode Operation 66 5 3 5 Dual Rate PULSATILE Warning 67 5 4 PGA Pump Test oi Sogi cu La M ni eA 68 5 41 T st DSSCripuoly gt cee te uy Sur axes died ga 68 D42 TOSTUSAGS E goes oe oe so educ e quede gee QUE 69 5 4 3 PCA Pump PULSATILE Warning 70 5 5 Occlusion Pressure ele ied feierte e eR 71 5 5 1 Measuring Occlusion Pressure 71 5 5 2 Checking the Nurse Call Alarm 71 5 6 AUIOSEQUENCES X RRERERERRRRAERKERRROK RR EREE RAE 73 5 6 1 Running Default Test Sequences 73 5 6 2 Reloading Default Test S
97. rt at the end of the test If an automatic output has been enabled the output port may be selected from either the Printer or the Serial port If the automatic output has been turned off the output port will indicate None and cannot be modified Operation Chapter 4 Page 52 INFUTEST 2000E OPERATING MANUAL Chapter Low Test Usage This chapter discusses the basic guidelines that should be followed to ensure good test results Also discussed are the test methods to follow for each of the test types and typical usage criteria 5 TEST USAGE GUIDELINES 5 1 General Rules 5 1 1 Test Fluids Infutest must be used with the right test fluid to ensure accuracy of the measurements displayed and to promote longevity of the internal valves and flow sensors Here are some recommendations regarding the use of various fluids in the Infutest a Use distilled water Distilled water may be obtained in bags or bottles from several areas in your hospital e g pharmacy stores If your hospital does not stock plain distilled or sterile water in a convenient container you may buy a gallon jug which may provide enough distilled water to supply several months of PM testing The advantage of using distilled water is you may keep your Infutest set up and primed all the time without damaging the internal valves or flow sensors Outgassing is less likely to occur with room temperature distilled water than wit
98. s a reminder to the user to set the pump to a specific rate VIBI etc before the test is begun The REMARK is presented as two lines of twelve characters in the sequence editor in order to fit on the screen Each of the two 12 character segments will flash alternately on the screen until the text editor is chosen When editing the rematk the first twelve character segment will be displayed with the first character highlighted As described under MFR each highlighted character may be changed with the or SET keys and the character to change is chosen with the SELECT key When the last character of the twelve character segment is highlighted and the SELECT key 15 pressed the second twelve Operation Chapter 4 Page 50 INFUTEST 2000 OPERATING MANUAL character remark segment will be presented for editing When the remark is complete press ENTER to accept the new text RATE TEST The rate test parameter has four preset options Single Dual PCA and None With the arrow gt pointing at RATE TEST press MODIFY to change the type of flow rate test desired The None option allows the selection of an occlusion test alone if desired Depending on the RATE TEST selected other parameters may change for consistency in the logic ie None will turn the timer Of f INF TIMER The infusion timer parameter sets the time limit for the rate test and should be calculated based on the desired rate and vol
99. s for Continuous Flow Measurement Elapsed Time Measurement Same as for Continuous Flow Measurement 1 2 Dual Rate Test 1 2 1 Continuous Flow Conditions ONLY I II III IV Flow Measurement coc g h i Nominal range Maximum flow measurable and displayed Minimum flow measurable and displayed Maximum display resolution Measuring time Accuracy Average flow Ranges Delivery period determination Internal nominal effective collection volume Volume Measurement 0 1 170 ml hr 200 ml hr 0 04 ml hr 0 001 ml hr 10 min at 0 1 ml hr 20 sec max above 6 ml hr 1 LOW range only Automatic 0 014 ml See 1 1 SINGLE RATE TEST Continuous Flow Measurement Back Pressure See 1 1 SINGLE RATE TEST Continuous Flow Measurement Elapsed Time Measurement See 1 1 SINGLE RATE TEST Continuous Flow Measurement Introduction Chapter 1 Page 3 INFUTEST 2000E OPERATING MANUAL 1 3 PCA Pump Test 1 3 1 Continuous Flow Conditions ONLY I II III IV Flow Measurement Bolus Delivery period o coc g h i Nominal range 0 1 170 ml hr Maximum flow measurable and displayed 200 ml hr Minimum flow measurable and displayed 0 04 ml hr Maximum display resolution 0 001 ml hr Measuring time 10 min at 0 1 ml hr 20 sec max above 6 ml hr Accuracy Average flow 1 Ranges LOW range only Lockout detection Automatic Internal n
100. se APPEND instead of OUTPUT as the file mode in the OPEN statement for device 2 Main Initialize COMI for communication with Infutest OPEN COMI 9600 N 8 1 CDO CSO DSO OPO RB2048 TB32 FOR RANDOM AS 1 Clear the PC s screen and prompt user to input pump info CLS RINT HARD DISK DATA LOGGER RINT Enter file name for storage of test data filename Enter pump make and model number Pump Enter pump equipment control no ECN Enter test rate ml hr TestRate Flush Channel A then start device pumping Press any key to proceed or lt ESC gt to abort now Wait here for user to press a key WUUUH UH UHTUH U Y DO C LOOP WHILE C IF C lt gt CHR 27 THEN Open data file and print header info Substitute APPEND for OUTPUT if you want the data appended to the end of an existing file OPEN filename FOR OUTPUT AS 2 PRINT 2 DATA LOG Remote ControllChapter 6 Page 97 INFUTEST 2000 OPERATING MANUAL Example 4 Hard Disk Data Logger cont d 2 TEST DATA FILE filenames 2 TEST DATE TIME DATE 2 PUMP MAKE MODEL Pumps 2 CONTROL NUMBER ECN 2 TEST FLOW RATE TestRate ml hr 2 SINGLE RATE TEST 2 2 Elapsed Flow Avg Flow Volume B Pres 2 Time ml h ml h anl mmHg lear PC screen and display data table headings Press lt gt to stop test anytime
101. ser to set up and start a test on the channel see Section 4 2 Setting Up a ot Press the DATA soft key to cause the channel s Data Log sub screen to be displayed This screen allows the user to scroll through the raw data which was acquired during the test If an occlusion pressure test was performed as part of an AutoSequence the DATA key will be replaced with OCCL PR The DATA selection will then be available from the Occlusion Pressure Summary screen or 5 Press the START soft key to return to the START menu to set up and start a new test If this key is pressed accidentally the SUMMARY screen may be restored by means of the PREV TST soft key on the channel s START more screen Operation Chapter 4 39 INFUTEST 2000E OPERATING MANUAL 4 7 Viewing the Data Log 4 7 1 Data Log Description Measurements acquired during a test and displayed on the TEST screen are saved inthe Data Log The Data Logis non volatile and has a maximum capacity of 900 flow measurements per channel 450 measurements in four channel mode This corresponds to approximately 2 hours and 15 minutes of Single Rate Test data at a flow of 100 ml hr The pressure Data Log may hold up to 700 data points 350 in four channel mode The Data Logis based on a circular memory which means that after the Data Log has been filled up with 900 flow measurements the Infutest data logger will continue to save newly acquired
102. splayed by Infutest may be erroneously HIGH The Volume Infused displayed on Infutest s SUMMARY screen will flash to indicate this potential uncertainty in the End Infusion Analysis When testing a pump for VTBI or Dose delivery accuracy stopping the test at the appropriate time is important to obtaining an accurate measure of the Volume Infused Infutest s programmable AutoSequences provide an infusion timer INF TIMER which may reduce this uncertainty in VTBI or Dose delivery test Refer to the programming instructions in Section 4 10 AutoSequences Test UsagelChapter 5 Page 63 INFUTEST 2000E OPERATING MANUAL 5 3 Dual Rate Test 5 3 1 Testing Piggyback Operation Piggybacking is the clinical term most often used to describe delivery of a Secondary Volume to Be Infused VTBI or Dose at a first rate followed by delivery of a Primary VTBI or Dose at a second and often lower flow rate Use the Dual Rate Test to evaluate Primary Secondary delivery or delivery piggybacking on continuous flow infusion devices which provide this feature Restrictions which apply to the Dual Rate Test are 1 continuous flow conditions only non pulsatile ii maximum flow rate is 170 ml hr average 200 ml hr peak atleast 1 0 ml of fluid must be delivered at the Secondary rate Infutest RATE 1 iv to detect the switch from Secondary delivery to Primary delivery the Secondary flow rate setting on the pump must be at least fi
103. st All data returned from Infutest to the controller including the error codes are terminated with a carriage return CR character In some cases Infutest will not transmit a response to a command For example Infutest may be busy sending measurement data to the controller and still receive additional commands from the controller These commands will not be acknowledged to prevent interference with the data transmission already in progress Infutest requires at least 50 milliseconds to interpret and begin executing a command once it has been received You must ensure that your computer programs do not transmit commands to Infutest faster than one command every 50 milliseconds To prevent overloading Infutest with commands it would be easiest to program your system to wait for a response from Infutest before proceeding to the next command Remote ControllChapter 6 Page 83 INFUTEST 2000E OPERATING MANUAL 6 5 Command List Test Control commands RT Run Test RS Run Sequence ST Stop Test Sequence Report Output commands PR Place Data to Print parallel in Output Queue DL Place Data to Download serial in Output Queue Get Data commands GS Get Test Summary Data up to 34 characters GR Get Real time Data during test up to 34 characters 6 6 Command Descriptions This section presents the IRC commands with detailed descriptions of each command Examples of each command show exactly how the command should be type
104. st base unit and all results are presented on the Infutest LCD display Overview Chapter 2 Page 9 INFUTEST 2000 OPERATING MANUAL On its front panel the Infutest provides a menu driven user interface which is implemented with a liquid crystal display LCD and four multi function software defined push buttons soft keys The left panel of the Infutest Figure f provides both a Centronix standard parallel port DB25 female for connection to an Epson Series or compatible printer and a RS 232 serial port DB25 male for data output to a personal computer or other data collection instrument Also located on the left panel are two Delrin twistlock self sealing connectors which serve as a fluid inputs for Channels A and B Fluid exits the Infutest via a Delrin twistlock connector which provides the Channel A amp B common output Figure 2 Inputs for pump Nurse Call signals and outputs for triggering PCA pumps are provided on the Infutest rear panel Figure 3 CHANNEL A INPUT SERIAL PORT i ES CHANNEL B INPUT PRINTER PORT Figure 1 Infutest left panel A amp B COMMON OUTPUT Figure 2 Infutest right panel Overview Chapter 2 Page 10 INFUTEST 2000E OPERATING MANUAL LCD CONTRAST _ ADJUSTMENT E NURSE CALL INPUTS _Z CHANNELS A amp B T T T POWER SUPPLY RECEPTACLE POWER SWITCH Figure 3 Infutest rear panel
105. stems please be advised that the original warranty covering your product becomes void when the tamper resistant Quality Seal is removed or broken without proper factory authorization We strongly recommend therefore that you send your instrument to Datrend Systems for service and calibration especially during the original warranty period In all cases breaking the tamper resistant Quality Seal should be avoided at all cost as this seal is the key to your original instrument warranty In the event that the seal must be broken to gain internal access to the instrument e g in the case of a customer installed firmware upgrade you must first contact Datrend Systems at 1 800 667 6557 You will be required to provide us with the serial number for your instrument as well as a valid reason for breaking the Quality Seal You should break this seal only after you have received factory authorization Do not break the Quality Seal before you have contacted us Following these steps will help ensure that you will retain the original warranty on your instrument without interruption WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation Datrend Systems will not be responsible for any injuries sustained due to unauthorized equipment modifications DSI DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PA
106. strictor TWISTLOCK EXTENSION SET Figure 4 Connection of stop cock to channel input channel ON gt FROM 21 gauge PUMP flow restrictor PRIME FLUSH 60 CC SYRINGE TO INFUTEST 2000 Figure 5 Stop cock position for priming flushing Set up Chapter 3 18 INFUTEST 2000 OPERATING MANUAL CHANNEL OFF EET ye FROM 219808 2000 Figure 6 Stop Cock position for channel OFF INFUTEST 2000E a La A amp B OUTPUT ra 36 MA COLLECTION NV VESSEL Figure 7 Connection fo A e Output To prime dry instrument a Rotate the Channel A stop cock to PRIME Figure 5 and the Channel B stop cock to OFF Figure 6 Fill the 60 cc syringe supplied with the Infutest with 60 cc of water connect the syringe to the open port on the Channel A stop cock and discharge the syringe into the fluid channel Rotate the Channel A stop cock to OFF and disconnect and refill the syringe Repeat this priming action at least five times Eventually water will begin to drain out of the A amp B Output as air is forced out of the Channel A fluid system and reservoir Set up Chapter 3 19 INFUTEST 2000 OPERAT
107. t AutoSequence has completed Format GS chanl parm l chan A B C or D parm 1 for SR Summary or for DR Summary RATE Z1 2 for DR Summary RATE 2 3 for PCA Summary 4 for OP Summary Examples GSA1 Get SR test Summary for channel A GSB3 Get DR test Summary for RATE 2 from channel B GSD5 Get OP test Summary from channel D RSM only Returns For parm 10r 2 Remote ControllChapter 6 Page 87 INFUTEST 2000 OPERATING MANUAL hh mm ss VVVVV ml AAAAA ml h Where hh mm ss infusion time hrs min sec VVVVV infused volume AAAAA average infusion rate For parm 3 VVVVV ml AAAAA ml h mm ss or VVVVV ml AAAAA ml h mm 55 Where VVVVV average bolus volume AAAAA average bolus delivery rate mm SS average lockout time between deliveries min sec uncertainty indicator for volume or time See Section 4 6 3 For parm 4 type PP P psi mmHg at mm ss Where type OVR for overpressure data MAX for maximum pressure data NRS for nurse call pressure data PP P occlusion pressure in psi pppp occlusion pressure in mmHg mm SS elapsed time to indicated pressure min sec Error Codes Returned Syntax error e Test AutoSequence not stopped Summary not available n Channel specified does not exist 6 6 7 Get Data Commands GET REAL TIME DATA Retrieves data in real time as displayed on the LCD during test execution Useful for logging data from e
108. t of the Infutest s flow sensors see Section 5 1 3 Contamination of Infutest s fluid system from use of dextrose TPN or other similar solutions is not covered under warranty 5 1 2 Pump IV Sets and Syringes The condition of the IV set or syringe you install in the device under test will largely determine the quality validity and accuracy of your test results You should obtain a new IV set for each make of pump you will be testing Use the IV set only with distilled water or clean tap water After testing the pump drain the IV set and store it in an air tight bag or container until another pump of the same type needs testing Do not store the set in a pump or use the set s roller clamp or pinch clamps to keep the set primed Doing so will quickly degrade the IV set and will likely influence the set s accuracy Test IV sets may remain usable up to several weeks if you treat them carefully as described above However accuracy of IV sets is usually not guaranteed by the manufacturer over such long intervals Ideally IV sets should be replaced in accordance with manufacturer s recommendations e g every 48 hours of testing so that test results reflect clinical usage of the infusion device Always install a new disposable syringe before testing a syringe pump The lubrication in disposable syringes tends to wear off after a few uses causing the syringe plunger to stick in the barrel A syringe pump equipped with an old worn ou
109. t provides nine 9 user programmable autosequences An AutoSequence defines a series of steps that the user would normally perform on a given make of infusion pump The steps consist of a timed flow rate test single rate dual rate or PCA a timed occlusion pressure test and an automatic output to either the serial or printer port Six pump test protocols have been preprogrammed as examples of how the AutoSequence testing is setup These tests may be overwritten or modified based on the user s needs Any changes made to the autosequences are retained in nonvolatile memory for future use To enter the AutoSequence Editor select EDIT SEQ from either the power up screen following the system self test or the START screen during normal operation The sequence editing screen is shown in Figure 29 and provides access to all of the test parameters that make up a test sequence The arrow lt or gt points to the parameter to be modified or edited and may be moved using the SELECT key AutoSequence 1 ENABLED No lt RATE TEST Single MFR ABBOTT INF TIMER 90 sec MOD PLUM XL OCCL TEST Off REMARK AUTO OUTPUT Summary Set pmp rate OUTPUT PORT Printer EXIT AUTOSEQ MODIFY SELECT Figure 29 AutoSequence editing screen The definition of the prompts displayed on the screen are ENABLED Determines if the test sequence will be available in the series of tests selectable for each channel The factory default setting is N
110. t syringe will deliver erratically and inaccurately and this will be evident as spikes appearing on Infutest s flow graph display Test UsagelChapter 5 55 INFUTEST 2000E OPERATING MANUAL If somebody gives you a pump to test and that pump has a used set or syringe in it take the set out of the pump and throw it away A set which has been used on a patient may contain saline dextrose or other solutions which may potentially damage the Infutest If you must re use an IV set for an incident investigation first rinse the IV set with distilled water and flush the Infutest thoroughly after the tests have been completed 5 1 3 Cleaning NOTE The cleaning procedure for the Infutest Series E is different ftom previous series of Infutest Improper cleaning of the unit may result in damage which is not covered under warranty The following cleaning procedure should be performed on the Infutest once per month if the instrument is used with tap water or once every three months if the Infutest is used exclusively with distilled water These recommendations apply to instruments which remain set up and primed at all times If the Infutest spends most of its time dry and in storage cleaning should be conducted more frequently ideally when the dry instrument is first primed during setup Cleaning after a period of dry storage is the preferred method of wetting the fluid system prior to use see Section 3 2 Priming In the event of
111. t system CANNOT be verified in the field using infusion devices intended for medical applications Such devices lack the stability and repeatability required for checking calibration Calibration of the flow measurement system CANNOT be verified in the field using measuring devices connected to the A amp B Output see Appendix Calibration of the flow measuring system may be checked using a precision syringe pump of laboratory grade which has itself been calibrated using a gravimetric test protocol and apparatus similar to that defined in IEC 601 2 24 Part 2 or equivalently ANSI Standard ID 26 We recommend Harvard Apparatus model 22 or model 44 with a precision ground glass syringe or glass microsyringe having the minimum volume necessary for the verification depending on the verification rates of interest Harvard Apparatus USA Holliston MASS 800 272 2775 ENGLAND Edenbridge Kent 44 1732 864001 www harvardapparatus com For verification rates in the range 50 to 200 ml hr B D Yale 2313 precision 20 cc is recommended If the test pump is a Harvard model 22 equipped with B D Yale 2313 the test pump should be tested gravimetrically at 50 ml hr and 200 ml hr prior to each verification run on the Infutest The pump should be allowed to dispense 1 ml at the selected rate before any test measurement is started Use an analytical balance to measure the mass of distilled water effused from the test pump over 10 minutes at 50 ml hr and ov
112. te for a few minutes The Dual Rate Test will measure the volume of the Bolus delivered the rate at which it was delivered RATE 1 and the background Basal flow rate RATE 2 5 3 5 Dual Rate PULSATILE Warning The Dual Rate Test is suitable for use only with continuous flow infusion devices If Infutest detects that the infusion device produces pulsatile flow a WARNING message will be displayed on the test measurement screen and the flow status indicator will flash PUL In this case changes in flow rate will not be detected and Infutest will remain measuring RATE 1 indefinitely Flow and volume measurements displayed on screen may also be erroneously LOW if the pulsatile warning message is posted during the Dual Rate Test Pulsatile infusion devices should be evaluated using the Single Rate Test see Section 5 2 Test UsagelChapter 5 Page 67 INFUTEST 2000E OPERATING MANUAL 5 4 PCA Pump Test 5 4 1 Test Description Use the PCA Pump Test to determine volumetric accuracy and verity lockout operation of continuous flow patient controlled infusion devices The volume of each Bolus delivered is precisely measured using the LOW range of the flow sensor and lockout time is determined to the nearest second based on observation of flow onset and cessation Restrictions which apply to the PCA Pump Test are i continuous flow conditions only non pulsatile ii maximum flow rate is 170 ml hr average 200 ml hr peak ii b
113. test procedure Prior to starting the test clear ot teset the Total Volume Infused on the DUT Most infusion devices provide a separate button for clearing the Total Volume Infused Test UsagelChapter 5 Page 62 INFUTEST 2000 OPERATING MANUAL When testing a pump for VTBI or Dose delivery accuracy Infutest should always be started first and the DUT started afterwards If the DUT is started before the Single Rate Test you will defeat Infutest s SynchroStart feature and the infused volume as measured by Infutest may be erroneously LOW If the test is not SynchroStarted it is likely that the volume dispensed from the DUT at the beginning of the infusion will be missed The DUT will typically produce an audio visual alarm the End Of Infusion alarm when it completes delivery of the VTBI or Dose Infutest s STOP key should be depressed the instant this alarm is produced to obtain an accurate measure of the actual volume delivered by the DUT Pressing the STOP key will activate Infutest s End Infusion Analysis EIA feature EIA calculates the total volume infused by the DUT using the measured Average Flow and the elapsed time at which the test was STOPped The EIA will be accurate provided the pump is running or just coming to a stop at the the STOP key is pressed If the STOP key is depressed substantially after the DUT ends the VTBI delivery you will introduce an error in the elapsed time of the test and the infused volume as di
114. th an appropriate OCCL TEST time based on the findings of your experiment in step a Choices available for the OCCL TEST include 0 5 min 1 min 2 min 3 min and so on Refer to Section 4 10 AutoSequences for programming instructions c Leave RATE TEST set to Single Ensure that the desired AutoSequence has ENABLED set to Yes Exiting the AutoSequence screen will save the changes you made d Set up and prime the pump Program the pump s SECONDARY RATE and V TBI or Dose with the settings listed in the previous table Set the pump s PRIMARY RATE to 50 ml hr and or Dose to 100 ml Clear the Total Volume Infused display on the pump e On Infutest s START screen select the desired AutoSequence Flush the fluid channel and press the GO key f After starting the Infutest start the SECONDARY infusion on the pump At completion of the Secondary delivery the pump rate should switch to 50 ml hr and about two seconds later Infutest should begin the pressure test the primary rate will not actually be tested the switch is intended only to set the rate to a suitable value for occlusion pressure testing Automatic report printout ot download if enabled will follow the end of the timed pressure test g The next time you choose to tun this AutoSequence an occlusion test will be performed along with the timed rate test and automatic report output Follow instructions d f each time you run the sequence Test Usage
115. the head created by elevation of the IV bag Install the set into the pump to stop the ftee flow and eliminate the pressure head before turning on the power to the Infutest Otherwise Infutest may display a pressure zero alarm at the end of its self test see Section 3 2 Priming 5 1 5 Flushing Prior to Test Startup Before starting a Single Rate Test or any AutoSequence incorporating a Single Rate Test the channels should be flushed to purge extraneous air bubbles from the channel s flow sensor This is always the safest way to avoid potential problems Do not forcefully inject large volumes of water into the channel when flushing Such action will generate troublesome air bubbles rather than purge them To minimize bubbles generated by turbulence gradually inject about 5cc from the priming syringe over a few seconds Test UsagelChapter 5 Page 58 INFUTEST 2000E OPERATING MANUAL You may also use the device under test DUT to purge the fluid channel if you wish If the DUT is pumping at 100 ml hr prior to test startup it will take the DUT at least 90 seconds to infuse the minimum amount required for purging If the DUT is set to a lower rate a proportionally longer time must be allowed In the process of measuring flow and volume Infutest deliberately introduces air bubbles into the test fluid as flow markers see Appendix B Operational Overview If air bubbles are present in the channel before a Single Rate Test
116. to more readily deal with pulsatile pumps 4 3 1 SynchroStart When a test is started the Infutest prompt reads Push GO then start pump At first this may seem backwards however Infutest will not start its first measurement until after it detects actual fluid flow This synchronizes the flow measurements with the beginning of fluid flow which is important on pumps which have a pulsatile flow pattern 4 3 2 End of Infusion Analysis End of Infusion Analysis ELA calculates the volume infused at the instant the STOP key is depressed or the automatic sequence reaches the end of the preset test time The only caveat with this calculation is it will be in error if the pump is stopped before the test is stopped To bring this to the user s attention the Volume Infused displayed on SUMMARY screens will flash on and off to remind the user that this value may be in error If there 1s any question about the accuracy of this value the full test DATA LOG may be reviewed and the second last value used 4 3 3 Flow Pattern Classification Different flow measurement algorithms are used based on the type of flow pattern detected During initial flow detection and continuously thereafter the flow pattern is analyzed to determine if it is smooth pulsatile or very pulsatile The flow pattern classification is indicated on the display in the STATUS indicator on the upper right corner of the screen If the flow is smooth and continuous th
117. toSequence for a Single Rate Dual Rate or PCA Pump Test is shown in Figure 19 SUMMARY CHAN B Jan 10 11 02 OCCLUSION PRESSURE TEST Max Occlusion Pr 3 6psi 186 mmHg measured at time 00 52 mm ss OUTPUT CHANNEL DATA START Figure 19 SUMMARY screen for Occlusion Pressure Test Channel B Operation Chapter 4 Page 38 INFUTEST 2000 OPERATING MANUAL This summary screen will include one of the following Max is the maximum pressure detected during the test in psi and Occlusion mmHg The time displayed corresponds to the time of the Pr detected maximum Nrs Call is the pressure measured at the time the nurse call signal was Alarm Pr activated The time displayed also coincides with the detection of the nurse call signal Overpressr indicates that the maximum system pressure of 50 psi was Reading exceeded during the test and the test was terminated The time displayed corresponds to the time of the overpressure condition 4 6 5 SUMMARY Screen Usage Operate the Infutest as follows when viewing the SUMMARY screens shown in Figure 16 to Figure 20 a Press the OUTPUT soft key to cause the channel s output submenu to be displayed This menu may be used to output the Summary and or Data Log to either the printer or serial port Press the CHANNEL soft key to cause the next channel s screen to displayed if the channel is not running a test the channel s SETUP menu will appear allowing the u
118. trol Chapter 6 Page 91 INFUTEST 2000 OPERATING MANUAL Example 1 Serial Connection Diagnostic SPTST BAS Serial Connection Test Infutest to PC c Datrend Systems Inc 2005 This diagnostic tests the serial connection between Infutest and the PC by sending a single character out 1 If Infutest is powered and properly connected to the PC Infutest should respond by sending back a character If the response returned is not ERROR is displayed on the PC screen If there is a fault in the connection itself e g bad cable wrong or defective COM port the PC displays TIMEOUT The OPEN COM statement may be edited to set the port to COM2 if desired However don t change any of the other parameters in the statement This is a good program to try first Main CLS PRINT SERIAL CONNECTION TEST INFUTEST TO PC PRINT Initialize COMI for communication with Infutest OPEN COMI1 9600 N 8 1 CDO CS1000 DS OPO RB2048 TB32 FOR RANDOM AS 1 Display TIMEOUT error message if no CTS on COMI within 1 second ON ERROR GOTO CommTimeOut DO DO Read character from keyboard C LOOP WHILE C Send test character to Infutest via RINT 1 C Read response from Infutest via COM1 If response takes more than 1 second device timeout error is generated NPUT 1 IFTdata Expected response is F IFTdata THEN PRINT O K ELSE PRINT ERROR END IF ReadKey LOOP UNTIL C x
119. ume to be infused for the pump test protocol For instance if the protocol recommends setting the pump to 400 ml hr and the volume to be infused to 10 ml the test time would be 10 ml 400 ml hr 3600 90 sec The infusion time may be changed by pressing the MODIFY key The timer edit screen works the same as the text edit screen except the available characters are limited to the numerical values 0 9 The maximum time selectable is 9999 sec 167 min OCCL TEST The occlusion test parameter has ten preset options 0 5 min 1 min 2 min 3 min 5 min 10 min 20 min 30 min 50 min and Off The time required for an occlusion test will depend on the flow rate and the occlusion pressure limit set on the pump Some experimentation may be required in setting up this parameter For each of the factory preset sequences the occlusion test has been turned off AUTO OUTPUT The test results may optionally be automatically output to the printer or the serial port at the end of the test There are three preset options Summary Log and Off If a test finishes while another channel is outputting data to the selected port the test results will be placed in the output queue as described in section 4 8 Output of Summary and Data Logs 4 51 INFUTEST 2000 OPERATING MANUAL OUTPUT PORT As described above the test results may optionally be automatically output to the printer or the serial po
120. ure test the Summary will report the pressure reading when the Nurse Call signal occurred This will normally coincide with the pump s occlusion alarm If the measured pressure exceeds 2586 mmHg 50psi during the test the internal occluding valve will be automatically opened the test will be stopped and the Summary will indicate an Over Pressure Reading It is important to note that most pumps sample their internal pressure signal at a relatively slow rate Ifthe pump is tested at too high a rate it is quite likely that the actual occlusion pressure will be higher than the maximum specified by the manufacturer In many cases Infutest will measure and report the actual pressure which may seem high If this occurs rerun the test at a lower rate try 50 ml hr and see if the occlusion pressure seems more reasonable 5 5 2 Checking the Nurse Call Alarm The Occlusion Pressure Test may also be used to check the operation of the Nurse Call Alarm output on an infusion device which incorporates this feature The test requires a cable with two insulated conductors plus braided shield to connect the Nurse Call input on the Infutest rear panel Figure 3 to the Nurse Call output of the infusion device A pair of unterminated cables for this purpose is available as an accessory from Datrend Systems NCA 1 A schematic of the unterminated cable is shown in Figure 32 Test UsagelChapter 5 Page 71 INFUTEST 2000 OPERATING MANUAL The Nurse C
121. utoSequence and have the report automatically output by the AutoSequence saved in a disk file on your computer The program first asks you to input a name for the file to save the data output at the end of the AutoSequence The program starts AutoSequence 1 running on Channel A after you input the file name and then asks you to run the pump AutoSequence 1 should be programmed with AUTO OUTPUT set to Summary or Log and OUTPUT TO set to Serial You can set the other parameters of AutoSequence 1 to whatever you wish The part of the program that does the downloading is fairly simple and can be easily transplanted to other programs which run just a Single Rate Dual Rate etc test as opposed to a complete AutoSequence AUTOSEQ BAS relies on the fact that all test reports sent from Infutest via the serial port are terminated with the BELL character CHR 7 as an end of file indicator This tells AUTOSEQ BAS that all the test data has been downloaded and the disk file can be closed AUTOSEQ BAS creates a new file for your test data or overwrites existing files If you want the test data appended onto a file which already exists in the current working directory use APPEND instead of OUTPUT as the file mode in the OPEN statement for device 2 Initialize COM1 for communication with Infutest OPEN COM1 96 0 N 8 1 CD CS DSO OPO RB2048 TB32 FOR RANDOM AS 1 Clear the PC s screen CLS Display some reminders on the scree
122. valleys in Infutest s FLOW graph when testing many linear peristaltic pumps at rates below 50 ml hr Such instantaneous variations are related to the design and precision of the finger mechanism which squeezes the tubing and to the quality and compliance of the tubing section being squeezed The opposite is true of many cassette pumps e g IMED 960 MedSystem 3 McGaw Horizon Siemens MiniMed III These pumps often produce more erratic instantaneous flow at higher rates as the pump compensates between delivering the required volume and refilling its cassette on alternating cycles Infutest s FLOW graph will normally show large peaks and valleys when testing many cassette pumps at rates over 500 ml hr Depending on the cassette pump large dips in the FLOW graph may appear at periodic intervals Caution should be exercised when testing some cassette pumps When set to high delivery rates such pumps may produce brief bursts of flow which are beyond Infutest s ability to measure peak flow exceeding 1700 ml hr In this case Infutest will appear to lock up failing to begin a measurement or halting a measurement in progress For example the IMED model 960 pump should not be tested at rates over 700 ml hr If set to 800 ml hr the IMED 960 will produce a vety high flow exceeding 1800 ml hr immediately following the cassette refill cycle Enteral feeding and TPN pumps e g Abbott Provider Sherwood Kangaroo 324 inventoried by many Home
123. ve times higher than the Primary rate setting For example an infusion device capable of piggyback operation might be programmed with the delivery schedule listed below and the actual delivered volumes and rates could be verified using the Dual Rate Test In a piggybacked infusion the Secondary medication is delivered first Infutest will display the Secondary delivery as RATE 1 and the Primary delivery as RATE 2 Delivery Flow Rate VTBI or Dose Infusion Setting Time Once the above rates and volumes have been programmed into the device under test DUT the Total Volume Infused on the DUT must be cleared or reset before starting the test Most infusion devices provide a separate button for clearing the Total Volume Infused Test UsagelChapter 5 Page 64 INFUTEST 2000 OPERATING MANUAL In a Piggyback test Infutest should a ways be started first and the DUT started afterwards 1f the DUT is started before the Dual Rate Test you will defeat Infutest s SynchroStart feature and the Secondary volume as measured by Infutest may be erroneously LOW sce Section 5 2 2 Test Usage Single Rate The DUT will typically produce an audio visual alarm the End Of Infusion alarm when it completes delivery of the Primary VIBI or Dose Infutest s STOP key should be depressed the instant this alarm is produced to obtain an accurate measure of the Primary volume delivered by the DUT If the STOP key is depressed after the DUT produces th
124. via RS 232C using the Infutest Remote Control IRC command set see Section 6 This command set allows the Infutest to be setup and controlled by a user designed program Data may be collected in real time allowing long term testing and data collection The Infutest incorporates a non volatile memory which allows the instrument to be disconnected from the line and transported without losing previously acquired test results At power up the user may select to view or output the contents of a channel s Data Log or Summary which are both retained in the non volatile memory Initial test settings are also preserved when the AC supply is disconnected A Windows based software accessory available from Datrend Systems the Infutest Data Transfer Program DTP facilitates transfer of test results from the Infutest to a personal computer and conversion of Infutest Data Log and Test Summary Report files to numeric data files suitable for importing into most spreadsheet or database programs DTP also has the ability to graphically display and print flow versus time graphs and trumpet error bounds graphs Overview Chapter 2 12 INFUTEST 2000 OPERATING MANUAL 2 2 Description of Test Procedures Each channel of the Infutest is capable of making the following measurements I Flow Rate ranging from 0 1 up to 1200 milliliters per hour i Effused Volume up to 9999 milliliters ii Pulsatile Flow ranging from 5 up to 1200 milliliters pe
125. will be testing These procedures will define the manufacturers recommendations for pump settings minimum test time and or collected volume The pump Service Manuals will include specifications for device performance or an acceptance range based on the volumetric test results Always refer to the manufacturer s procedures and recommendations before using Infutest to test your pumps Test UsagelChapter 5 79 INFUTEST 2000 OPERATING MANUAL Test UsagelChapter 5 Page 80 INFUTEST 2000 OPERATING MANUAL Remote Control This chapter describes the Infutest serial communications features and explains the use of the commands used to request information from the Infutest or to remotely control its operation 6 REMOTE CONTROL 6 1 Overview Infutest Remote Control IRC is the interactive software communications protocol command structure which allows Infutest to communicate with an external controller such as a personal computer or other device via RS 232 Using these communications protocols Infutest may receive and respond to commands to start tests stop tests and transmit measurement data through the serial communications port IRC s comprehensive and flexible set of commands allows the creation of simple programs on a personal computer to automatically perform and document any pump test to any desired protocol IRC is also compatible with other manufacturer s automated test instrumentation However
126. xtremely long pump tests or to run multiple tests or to create Visual Basic Visual C data acquisition programs Data is Remote ControllChapter 6 Page 88 INFUTEST 2000E OPERATING MANUAL returned as a comma delimited string of up to 34 ASCII characters terminated by a carriage return Data must be retrieved from the LCD before it changes or that particular data is lost Format GRI chan chan A B C or D Examples GRA Get displayed data from channel A GRD Get displayed data from channel D RSM only Returns For SR DR and PCA test data lt type gt hh mm ss FFFFF AAAAA VVVVV ppp Where type A SR low range flow LOW B SR high flow range HI C SR pulsatile flow PUL D SR very pulsatile flow VPF E SR interrupted flow IFL F DR rate 1 data G DR rate 2 data H PCA bolus flow data I DR PCA pulsatile warning data J DR PCA end of delivery data K SR or DR end of infusion data L PCA end of test averages hh Elapsed time hours mm Elapsed time minutes ss Elapsed time seconds FFFFF Instantaneous flow rate ml h AAAAA Average flow rate ml h VVVVV Effused volume ml ppp Back Pressure mmHg Additional DR test data indicates start of rate 1 indicates start of rate 2 M N Additional PCA test data O NNN Q mm ss start of PCA bolus delivery NNN lockout time between bolus delivery Remote ControllChapter 6 Page 89 INFUTEST 2000 OPE

MN-040f Infutest 2000 Operators Manual

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