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DELTEC Cadd Legacy Infusion Pump Service Manual

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1. 23 CADD Legacy PCA pump scscscrwivexcavene 23 Air Detector 1 25 Upstream Occlusion Sensor 101 25 Occlusion Pressure Range Tests ssces0e 25 Accuracy Tesini ansarin 27 CADD Legacy 1 pump 2 29 Air Detector Test cv cissisvissessaevsccsatvesseasesstee 30 Upstream Occlusion Sensor 1651 30 Occlusion Pressure Range 1 0518 31 Accuracy Teng i xicsseieessiidaten cide tas 32 CADD Lesacy PLUS 34 Air Detector Test viccisssssvilentisisvienasiceniians 35 Upstream Occlusion Sensor 1051 36 Occlusion Pressure Range Tests sccseee0e 36 Accuracy TENNE arurae a 37 Cleaning and Functional Testing 40 Introduction This Technical Manual is intended to provide an understanding of the mechanical and electri cal operation of the CADD Legacy PCA CADD Legacy 1 and CADD Legacy PLUS Computerized Ambulatory Drug Delivery pumps to persons familiar with these devices The CADD Legacy PCA CADD Legacy 1 and CADD Legacy PLUS pump Operator s Manuals should be used in conjunction with this publication for complete information This manual also outlines cleaning and func tional testing procedures that can be performed on the CADD Legacy PCA CADD Legacy 1 and CADD Legacy PLUS pumps WARNING This Technical Manual must be used by Bio medical Technicians only Do not permit patients to have access to this manual Do not disclose to the patient the pump s security codes or any other infoma
2. 0 025 0 025 x 100 2 5 Table 12 Volumetric percentage calculation 28 9 If the accuracy error percentage is greater than 6 repeat the test with a new Medication Cassette Reservoir If the pump fails a second time call Deltec s Customer Service Department Example Actual Delivery Volume 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml Intended Delivery Volume 20 0 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 CADD Legacy 1 Pump Power up Check e Insert batteries or press and observe the LCD during power up The first screen will display the serial number model number and software number with revision level The second screen will display 32 character blocks If LEC and four digits appear prior to the pump displaying the 32 charac ter blocks the pump has experienced an electrical or mechanical fault and should be returned for service If no error message is immediately shown the pump has powered up normally The pump will then sequen tially display all of the programmed values and beep at each screen After all screens are displayed successful power up is indicated with six audible beeps and the STOPPED screen displayed Continue with the Lock check To Access Biomed Functions Loop 1 Press Cow The current lock level will appear 2 Press or Ge CODE 0 will appear 3 Press AN
3. CADD Legacy 1 Pump CADD Legacy PCA Pump CADD Legacy PLUS Pump Deltec 58 4 SMITHS INDUSTRIES SIMS Medical Systems For detailed instructions specifications warnings warranties and additional information on operat ing CADD pumps please refer to the Operator s Manual supplied with the product If you have additional comments or questions concerning the operation of CADD pumps please call this num ber 800 426 2448 Our staff is available to help you twenty four hours a day with the programming and operation of CADD pump infusion systems The issue date of this Technical Manual is included on the back cover for the user s information In the event one year has elapsed between the issue date and product use the user should contact SIMS Deltec Inc to see if a later revision of this manual is available Issue Date January 2000 Table of Contents 1 0 1 Limited Warranty Exposing CADD Pumps to Radiation Ultra sound or MRI or use near ECG equipment 1 CADD Legacy Pump Delivery Moaes serene e n 2 Specifications Nominal ecscccccsccccessccessseeeesees 5 Compatible Medication Cassette Reservoirs and CADD Administration Sets ccc 7 Remote Dose 7 0 nosica 8 Battery gt 8 DURACELL Alkaline Battery 1 1106 8 COMSEICHION corinne eienn 11 Theory of Operation e ssesessseresssesesessseess 12 Keyboard 77711
4. 5 minutes between 20 minutes and 24 hours Default 24 hours Doses Per Hour 1 to 12 doses in 1 dose increments will also be limited by the Demand Dose Lockout value Default 1 dose hr integral anti siphon valve or an attached CADD Administration Set with integral or add on anti siphon valve Doses Given 0 to 999 Doses Attempted 0 to 999 Given 0 to 99999 95 in 0 05 unit increments or 0 to 99999 99 in 0 01 unit increments increments converted to current units based on concentration Clinician Bolus 0 05 ml to 20 00 ml or mg or mcg equiva lent See Tables 1 2 and 3 for scroll ranges Delivery rate Continuous Rate Clinician Bolus 125 ml hr nominal CADD Legacy 1 pump Continuous Delivery Mode Specifications Reservoir Volume 1 to 9999 or Not In Use programmable in 1 ml increments displayed in 0 1 ml increments Default 1 ml Continuous Rate 1 to 3000 ml 24 hr in increments of 1 ml 24hr Default 0 ml 24hr Given 0 to 99999 95 in 0 05 ml increments CADD Legacy PLUS pump Intermittent Delivery Mode Specifications Reservoir Volume 1 to 9999 or Not In Use programmable in 1 ml increments displayed in 0 1 ml increments Default 1 ml Dose Volume 0 1 to 1000 0 ml in increments of 0 1 Default 0 0 ml Dose Duration 1 minute to 24 hours in the following increments 1 minute from 00 01 to 00 10 5 minutes from 00 10 to 24 00 Default 30 minutes Dose Cycle 10 minutes to 96 hours in
5. Start the pump When the pump is running note when the high pressure alarm is acti vated 7 The pump should alarm when the pump delivers between 1 and 2 activations Occlusion Pressure Range Test II Description An adjustable metered pressure source is connected to the Medication Cassette Reser voir tubing The pressure is slowly increased until the high pressure alarm sounds Equipment needed e Pressure gauge 40 psi 1 psi 2 76 bar 0 07 bar gt Pressure vessel partially filled with water e Pressure regulator 40 psi 2 76 bar 0 07 bar e 50 or 100 ml Medication Cassette Reser voir containing water CAUTION At the completion of the test the pressure must be reduced to zero before detaching the cassette from the pump otherwise the cassette may rupture Safety glasses should be worn while conducting or observing this test Procedure 1 Insert two AA batteries and wait for the pump to power up TM 2 Attach a Medication Cassette Reservoir to the pump Lock the cassette NOTE The pressure from the source must be zero when the cassette is attached 3 Assemble the apparatus as shown in Figure 13 4 Connect the Medication Cassette Reser voir outlet tube to the metered pressure source Testing Procedures CADD Legacy PLUS pump continued NOTE Do not use a CADD Extension Set with Anti siphon Valve 5 Program the pump for a continuous rate of 125 ml h
6. detection alarm Upstream Occlusion Sensor Test Verify that the Upstream Occlusion Sensor is turned on See page 29 To Access Biomed Functions Loop Obtain a CADD Administration Set with bag spike and anti siphon valve Also obtain a clamp slide clamp or hemostat Insert the CADD Administration Set spike into an appropriate standard IV bag filled with water Attach the cassette to the pump Prime the entire fluid path Program the pump to deliver a continuous maximum rate Press and hold to start the pump Clamp the tubing halfway between the IV bag and the pump The pump should alarm within three activations after clamping the tubing Testing Procedures CADD Legacy 1 pump continued Occlusion Pressure Range Tests Occlusion Pressure Range Test I Description Pressure is generated by activating the pump ing mechanism with an attached filled clamped Medication Cassette Reservoir The pump is started and a Demand Dose is given until the high pressure alarm sounds Equipment needed 50 or 100 ml Medication Cassette containing distilled water TM Reservoir Procedure 1 Insert two AA batteries and wait for the pump to power up 2 Attach a Medication Cassette Reservoir containing water to the pump Lock the cassette 3 Prime the Medication Cassette Reservoir tubing The tubing should be filled with fluid to the end of the luer lock connector The system must be free from a
7. s Manual for specific defaults Order of Error Code Events 1 There is a continuous two tone audible alarm and the display will read Error Detected E XXXX NOTE XXXX is a 4 digit code 2 To silence the error code alarm remove the batteries 3 At each subsequent power up the pump will display the initial power up screen and then the following screen LEC XXXX Thus there is always a display of the Last Error Code LEC detected by the micro processor 20 Error Code Range Description 1010 1040 1110 1160 1210 1270 1310 1340 1410 1450 1510 1530 1610 1670 1710 1720 1810 1872 Software Application Errors Software Control Errors CRC Errors Real Time Clock Errors Standard Delivery Calcula tion Errors Air Detector System Errors CPU Test Errors Miscellaneous Hardware Errors Motor Errors Table 10 CADD Legacy pump error codes Cleaning and Inspection Procedures Inspection Recommendation Deltec recommends annual functional inspec tion on the CADD Legacy 1 CADD Legacy PLUS and CADD Legacy PCA pumps The following inspection procedures should be performed annually to verify function and accuracy NOTE Persons performing the following tests and procedures should be familiar with the Deltec CADD Legacy pump Please read the Operator s Manual supplied with the pump before proceeding WARNING CADD Legacy pu
8. 01 Concentration MG Concentration Values between 0 50 and 100 0 0 10 x 50 Values between 100 0 and 1000 0 1 00 Values greater than 1000 0 10 0 MCG 10 of Values between 0 1 and 100 0 10 Concentration Concentration Values between 100 and 1000 1 00 x 50 Values greater than 1000 10 00 Table 1 PCA delivery mode continuous rate scroll ranges Milligrams Micrograms Concentration Demand Dose Clinician Bolus Concentration Demand Dose Clinician Bolus mg ml increment max increment max mcg ml increment max increment max 0 1 0 01 0 99 0 01 0 05 9 9 0 05 20 0 2 0 02 1 98 0 02 0 10 19 8 0 10 40 0 3 0 03 2 97 0 03 0 15 29 7 0 15 60 0 4 0 04 3 96 0 04 0 20 39 6 0 20 80 0 5 0 05 4 95 0 05 0 25 49 5 0 25 0 05 9 9 0 05 0 50 99 0 0 50 200 0 10 19 8 0 10 0 75 148 5 0 75 300 0 15 29 7 0 15 1 00 198 0 1 00 400 0 20 39 6 0 20 1 25 247 5 1 25 500 0 25 49 5 0 25 1 50 297 0 1 50 600 0 50 99 0 0 50 1 75 346 5 1 75 700 0 75 148 5 0 75 2 00 396 0 2 00 800 1 00 198 0 1 00 2 25 445 5 2 25 900 1 25 247 5 1 25 2 50 495 0 2 50 1 50 297 0 1 50 2 75 544 5 2 75 1 75 346 5 1 75 3 00 594 0 3 00 2 00 396 0 2 00 3 25 643 5 3 25 2 25 445 5 2 25 3 50 693 0 3 50 2 50 0 2 50 3 75 742 5 3 75 2 15 544 5 2 75 400 0 4 00 3 00 594 0 3 00 4 25 841 5 4 25 3 25 643 5 3 25 450 891 0 4 50 3 50 693 0 3 50 4 75 940 5 4 75 3 75 742 5 3 75 5 00 990 0 5 00 400 0 4 00 10 00 1980 0 10 00 4 25 841 5 4 25 15 00 0 15 00 45
9. 11 Gravimetric percentage calculation 27 Testing Procedures CADD Legacy PCA pump continued Example Pre delivery Weight 61 1 g Post delivery Weight 6 8 Weight of Amount Delivered 19 5 g 19 5 ml Volume of Amount Delivered 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml Intended Delivery Volume 20 0 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 Volumetric Accuracy Testing Description A predetermined amount of water is delivered into a collection device such as a burette or graduated cylinder The amount of water delivered is compared to the amount that the pump should have delivered Nominal system accuracy is given in the technical specifications section for the pump That is under the test conditions described below the accuracy of the pump and Medica tion Cassette Reservoir will be nominal with a 90 confidence level The nominal test conditions are as follows degassed water at 25 5 C without back pressure Equipment needed e 50 or 100 ml Medication Cassette Reser voir e 50 or 60 ml syringe CADD Extension Set with Anti siphon Valve e A fluid collection device such as a burette or a class A 25 ml capacity graduated cylinder gt 40 ml of room temperature water NOTE The test procedure calls for the use of a Medication Cassette Reservoir and a CADD Extension Set with Anti siphon Val
10. 12 Data Memory in Real Time Clock RAM 12 12 Battery Backed RAM wisssccccsssecesssscessscceesseeees 12 Time Base 0 7 7 7 7 12 LGD CirCuttry scssidieeuidexisciadeciadess sic ctelesivacisahs 12 LED Indicator sissiseswsssiesaieciziassstnciessecte 13 Flash PROM Technology cccccccsscccessseeesseeeees 13 Audible Alarm Circuitry coccccccccccscccccssseesseeees 13 Watchdog Timer 70 13 Motor Drive Motor Watchdog Circuit 13 POWE CI CUIEPY siscesasvcctiaicadtatvieestieeianssevenciass 14 Voltage Reference Circuit ccccccccsccesssesseeerees 14 Pumping Mechanism cccccsccccsscsesscesseeerseeseees 14 Pumping Characteristics 8 07 15 Ar DOOF virsiin iiin AAN 15 Downstream Occlusion 9007080 16 Upstream Occlusion Sensor ccsccccssssceessseeees 16 Cassette Attachment 1201601107 16 Safety Features and Fault Detection 17 Hardware Safety Features gt 17 Software Safety Features cccccccccccccsssceessseeees 19 Hardware and Software Fault Detection 20 7 20 Order of Error Code 1207718 20 Cleaning and Inspection Procedures 21 Inspection Recommendation o cccscccccssseeevees 21 6 Mszacesvesscepstutnasstosteyeesstessaseteictassees 21 Battery Contact Cleaning wccccccssccccsssccesseeeeees 21 Visual Inspecties crevne EES 22 Mechanical Inspection gt 22 Testing Procedures scccccscenscnsaccontocavenarevecs 23 Testing Recommendation csscccsseceseesseeeees 23 Changing to Lock Level 0 1 1 0
11. a series of power FET transistors passive com ponents and two voltage comparators Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on If the motor runs for more than an average of 4 seconds the circuit will time out and disable the motor A unique feature of this circuit is that control lines to and from the microprocessor circuit allow the microprocessor to perform a com plete functional test of the motor drive circuit without running the motor The microproces sor performs this test function every several minutes to assure its continued functionality An input from the watchdog circuit prevents motor operation if the watchdog timer expires Rotation of the motor is sensed by the micro processor via an infrared sensitive photo detector An infrared light source is mounted 13 so that its light beam illuminates the infrared detector An opaque flag is mounted concentri cally to the camshaft and rotates with it be tween the infrared light source and detector When the flag interrupts the light beam the output of the detector is sensed by the micro processor via an input port bit Power to the infrared LED light source is controlled by the motor drive circuit and is off when the motor is not running to conserve battery life In the microprocessor software multiple checks are made on motion of the camshaft When the motor is commanded to start the infrared s
12. cassette is delivery weight This weight includes the then attached to the pump and the pump is set empty Medication Cassette Reservoir to deliver a certain amount of water The CADD Extension Set and weight of the cassette is then removed and weighed again water The amount of water delivered is compared to 4 Attach the Medication Cassette Reservoir the amount that the pump should have deliv to the pump Program the reservoir volume ered to 20 ml Now press This value is the Nominal system accuracy is given in the intended delivery volume Remove the slide technical specifications section for the pump clamp That is under the test conditions described 5 With the pump in Lock Level 0 program a below the accuracy of the pump and Medica continuous rate of 3000 ml 24hr Start the tion Cassette Reservoir will be nominal with pump and deliver 20 ml a 90 confidence level The nominal test p conditions are as follows degassed water at 25 6 Again secure the slide clamp hae close as 5 C without back pressure possible to end of the CADD Extension Set luer lock connector Remove the Medication Equipment needed Cassette Reservoir from the pump and weigh the entire Medication Cassette e 50 or 100 ml Medication Cassette Reser Reservoir CADD Extension Set assembly yom This is the post delivery weight e 50 or 60 ml syringe 7 Calculate the difference in weight between e CADD Fxtension Set with
13. syringe with 40 ml of water Transfer the water into a Medication Cassette Reservoir Volumetric Accuracy Testing 2 Remove any air from the Medication Cassette Reservoir by aspirating the air Description with the syringe Attach the CADD Exten sion Set with Anti siphon Valve Prime the A predetermined amount of water is delivered f tubing so it is filled with fluid to the end of into a collection device such as a burette or 2 the CADD Extension Set luer lock connec graduated cylinder The amount of water delivered is compared to the amount that the Qi pump should have delivered 3 Insert the end of the CADD Extension Set 2 ee into the fluid collection device Nominal system accuracy is given in the technical specifications section for the pump 4 Attach the Medication Cassette Reservoir That is under the test conditions described to the pump Program the Reservoir Volume below the accuracy of the pump and Medica to 20 ml This is the intended delivery tion Cassette Reservoir will be nominal with volume Remove all clamps a 90 confidence level The nominal test conditions are as follows degassed water at 25 5 C without back pressure Pre Post Weight of Intended Inaccuracy Accuracy Accuracy Delivery Delivery Amount Delivery Volume Error Error Percentage Weight Weight Delivered Volume 61 1 g 41 6 19 5 g 19 5 ml 20 ml 0 5 ml 0 5 ml 20 0 ml 0 025 x 100 2 5 0 0
14. the alarm in the instance where all power is lost while pump is in the RUN mode There is enough energy in the super capacitor to drive the audible alarm for 3 minutes when the pump has been in the RUN mode for 2 minutes or longer Watchdog Timer Circuit Watchdog timer circuitry is provided to moni tor the status of the microprocessor If the microprocessor fails to function properly the watchdog circuit issues a reset signal which disables the motor and enables the audible alarm To assure proper function the micro processor must strobe the watchdog circuit at least once every second in order to prevent the watchdog from performing its reset function The reset output from the watchdog circuit is a pulse output This acts to jump start the microprocessor This unique feature allows the microprocessor to test the watchdog circuit on every power up By setting a flag in memory and not strobing the watchdog the micropro cessor can force a watchdog time out After being reset the microprocessor checks the status flag to see if this was a time out test If so the microprocessor verifies the watchdog s ability to disable the motor and then continues normal power up activities If a reset occurs when the microprocessor is not expecting it the microprocessor traps the event sounds the audible alarm and displays an error message on the LCD Motor Drive Motor Watchdog Circuit The motor drive circuitry is composed of
15. when the microprocessor was not expecting it the microprocessor traps the event sounds the audible alarm and dis plays an error message on the LCD Motor Drive Motor Watchdog Circuit Motor drive circuitry is composed of a series of power FET transistors passive components and two voltage comparators Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on If the motor runs for more than an average of 4 seconds the circuit will time out and disable the motor A unique feature of this circuit is that control lines from the micropro cessor can perform a complete functional test of the motor drive circuit without running the motor The microprocessor performs this test function every several minutes to assure its continued functionality An input from the watchdog circuit prevents motor operation if the watchdog timer expires _ AUDIBLE ALARM VOLTAGE MONITOR MOTOR WATCHDOG POWER INPUT WATCHDOG KEYBOARD SENSORS REAL TIME CLOCK Figure 10 CADD Legacy pump hardware block diagram 17 Voltage Voltage Motor Status Source Trip Point Trip Point CADD Legacy Pump Status Audible alarm 3 beeps every 5 minutes Low Bat message appearst Audible alarm 3 beeps every 5 minutes Low Bat message appears lt 4 75V 5 Volt supply Running Battery Depleted message appears t motor voltage lt 1 0 V Battery Runnin
16. 0 891 0 4 50 20 00 3960 0 20 00 4 75 940 5 4 75 25 00 4950 0 25 00 5 00 0 5 00 Table 3 Demand dose clinician bolus scroll ranges Table 2 Demand dose clinician bolus scroll ranges micrograms milligrams Milliliters Demand Dose Clinician Bolus increment max increment max 0 05 9 9 0 05 20 Table 4 Demand dose clinician bolus scroll ranges 4 milliliters Specifications Nominal General Pump Specifications Resolution Medication Cassette Reservoir or CADD Administration Set 0 050 ml pump stroke nominal Size 4 1 cm x 9 5 cm 11 2 cm 1 6 in x 3 8 in x 4 4 in excluding cassette or other accessories Weight 391 g 13 8 oz including 2 AA batteries empty 100 ml Medication Cassette Reservoir and air detector excluding other accessories Pump Alarms Low battery power depleted battery power battery dislodged pump stopped pump fault low reservoir volume high delivery pressure air in line disposable not attached when run attempted motor locked upstream occlusion reservoir volume empty program incomplete remote dose cord removed key stuck disposable detached power removed value not saved Bolus Volume at Occlusion Alarm Pressure 0 050 ml resolution sets reservoirs lt 0 15 ml Power Sources Two AA alkaline batteries such as DURA CELL or EVEREADY Energizer AC adapter An internal battery powers the clock When it is depleted it cannot reliably maintain th
17. 25 Table 15 Gravimetric percentage calculation 38 Testing Procedures CADD Legacy PLUS pump continued 5 Program a continuous rate of 125 ml hr Start the pump and deliver 20 ml 6 When delivery is complete record the volume of fluid delivered This is the actual delivery 7 Find the difference between the volume of the amount delivered and the intended delivery volume This is the inaccuracy volume 8 Divide the inaccuracy volume by the intended delivery volume and multiply by 100 This is the accuracy error percentage See table 16 9 If the accuracy error percentage is greater than 6 repeat the test with a new Medication Cassette Reservoir If the pump fails a second time call Deltec s Customer Service Department Example Actual Delivery Volume 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml Intended Delivery Volume 20 0 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Percentage Volume Volume 20 ml 19 5 ml 0 5 ml 0 5 ml 20 0 ml 0 025 0 025 x 100 2 5 Table 16 Volumetric percentage calculation CADD Legacy Pump Cleaning and Functional Testing Checklist The following checklist is provided as a tional testing for the CADD Legacy guide only to assist in establ
18. 4 volts when motor is off or 1 8 volts when motor is active An Analog to Digital Con 18 verter ADC built into the microprocessor allows the microprocessor via software to monitor the battery voltage and motor voltage At the Low Battery Warning threshold the microprocessor enables a periodic series of beeps and displays a Low Bat warning message on the LCD The second level is Battery Depleted Warning threshold As the voltage operating the motor reaches a nominal value of 4 75 volts the software disables delivery places a Battery Depleted message on the LCD and enables a continuous two tone audible alarm The third level is a hardware reset which is reached when the battery voltage decays to a nominal value of 1 0 volt At this point a hardware reset circuit is triggered which places the microprocessor in reset This prevents ambiguous microprocessor operation as the battery voltage continues to decay The hard ware reset continues until the battery is com pletely discharged or until it is removed A hardware reset can only be cleared by replac ing the old batteries with two fresh ones t The pump emits 3 beeps every 5 minutes and the message Low Bat appears on the pump s display indicating that the battery power is low but the pump is operable tt The pump emits a continuous variable tone alarm and the message Battery Depleted appears on the display the battery power is too low to
19. 5 minute incre ments Default 4 hours KVO Rate 0 to 125 0 ml hr in increments of 0 1 ml hr Default 0 ml hr Dose Starts in Immediate or 1 minute to 96 hours in the following increments 00 01 from 00 00 to 00 10 00 05 from 00 10 to 96 00 Default Immediate Continuous Delivery Mode Specifications Reservoir Volume 1 to 9999 or Not In Use programmable in 1 ml increments displayed in 0 1 ml increments Default 1 ml Continuous Rate 0 1 ml hr to 125 0 ml hr in increments of 0 1 ml hr Default 0 0 ml hr Given 0 to 99999 95 in 0 05 ml increments Biomed Functions Specifications Air Detector Status Off On low On high Default On high Upstream Occlusion Status Off On Default On Delivery Mode CADD Legacy PLUS only Continuous Intermittent Default Intermittent Compatible Medication Cassette Reservoirs and CADD Administration Sets e 50 ml or 100 ml Medication Cassette Reservoir used with the CADD Extension Set with Anti siphon Valve CADD Administration Set with integral anti siphon valve with or without bag spike allows use of flexible plastic bag or sterile vial with injector CADD Administration Set with add on anti siphon valve and bag spike allows for gravity priming before attaching the add on anti siphon valve Remote Dose Cord Deltec provides a Remote Dose Cord for the CADD Legacy PCA pump which is an exten sion of the key The push b
20. Anti siphon the pre delivery weight and the post deliv Valve ery weight This is the weight of the amount delivered One ml of water at 20 C weighs e A balance accurate to 0 1 g 1 gram 40 ml of room temperature water 8 Find the difference between the volume of the amount delivered and the intended delivery volume This is the inaccuracy volume Pre Post Weight of Intended Inaccuracy Accuracy Accuracy Delivery Delivery Amount Delivery Volume Error Error Percentage Weight Weight Delivered Volume 1 41 6 8 19 5 g 19 5 ml 20 ml 0 5 ml 0 5 ml gt 20 0 ml 0 025 100 2 5 0 025 Table 13 Gravimetric percentage calculation 32 Testing Procedures CADD Legacy 1 pump continued 9 Divide the inaccuracy volume by the in tended delivery volume and multiply by 100 This is the accuracy error percentage See Table 13 10 If the accuracy error percentage is greater than 6 repeat the test with a new Medication Cassette Reservoir If the pump fails a second time call Deltec s Customer Service Department Example Pre delivery Weight 61 1 g Post delivery Weight 41 6 Weight of Amount Delivered 19 5 g 19 5 ml Volume of Amount Delivered 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml Intended Delivery Volume 20 0 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 Volu
21. Hardware Safety Features Key hardware safety features include a watch dog timer circuit motor drive and motor watchdog circuits cassette present sensor circuit and a voltage detector circuit Each safety circuit performs a unique function to insure the overall safety of the device See Figure 10 Watchdog Timer Circuit The microprocessor must send an appropriate signal to the watchdog circuit at least once per second If the microprocessor does not the watchdog circuit will time out and shut down the pump controller Watchdog timer circuitry is provided to monitor the status of the microprocessor and disable the motor and enable the audible alarm if the microprocessor fails to function properly The microprocessor must strobe the watchdog circuit at least once every second in order to prevent the watchdog from performing its reset function The reset output from watchdog circuit is a pulse output This acts to jump start the microprocessor This unique feature allows the microprocessor to test the watchdog circuit on every power up By setting a flag in memory and not strobing the watchdog the LCD DISPLAY PROGRAM MEMORY microprocessor can force a watchdog time out After being reset the microprocessor checks the status flag to see if this was a time out test If so the microprocessor verifies the watchdog s ability to disable the motor and then continues normal power up activities If the reset occurred
22. activation should occur every three seconds Approximately twenty seven seconds and ten activations later the Reservoir Volume alarm should occur The display should show Reservoir Volume Empty GIVEN Mode Check Press Qer to advance to the Given screen The display should now show 1 00 ml If the above steps have not been followed exactly a different value may appear Press the key The display should now show 0 00 ml Air Detector Test This test will verify the function of the air detector To perform this test the air detector must be turned on The previous program from the Activation Timing Check can be used to perform this test 30 Attach an empty Medication Cassette Reservoir or CADD Administration Set to the pump Secure it using the lock button Thread the tubing through the air detector groove Start the pump The pump should respond with a continuous two tone alarm and the display should read Air In Line Detected Press Qer or to silence the alarm and remove the Medication Cassette Reservoir or CADD Administration Set Now attach a Medication Cassette Reser voir containing fluid or a primed CADD Administration Set to the pump Make certain there is no air in the fluid path Secure it using the lock button Thread the tubing through the air detector groove Program the Reservoir Volume to 1 0 ml Start the pump The pump should deliver without an air
23. ate only 2 patient activated dose only and 3 continuous rate and patient activated dose See figure 1 The CADD Legacy PLUS pump may be programmed to deliver in one of two modes 1 Continuous 2 Intermittent See figures 2 and 3 The CADD Legacy 1 pump operates in continuous mode See figure 2 Figure 4 shows a diagram of the CADD TM Legacy pump PCA Delivery Profile The PCA patient controlled analgesia delivery mode is used for therapies that require a continuous rate of infusion patient controlled demand doses or both such as patient controlled analgesia Continuous Mode Delivery Profile The Continuous delivery mode allows the infusion of drug at a constant programmed rate Intermittent Mode Delivery Profile The Intermittent delivery mode allows the infusion of a specific volume of drug at regular programmed intervals Power Jack Accessory Jack AC Indicator Cassette Dose Key on CADD Legacy PCA Front View Threaded Power Jack symbol Jack Symbol Battery Compartment Cassette Lock CADD Legacy PCA Cassette Lock Rear View Figure 4 Front and Rear views of the CADD Legacy Pump Features are identical on all CADD Legacy pumps except as illustrated for the CADD Legacy PCA pump PCA Delivery Mode Scroll Ranges Units Starting Increment Maximum ML 0 10 All values 0 10 50 00 10 of Values between 0 01 and 0 5 0
24. board status by accessing special memory locations in the keyboard encoder The Remote Dose Cord button CADD Legacy PCA pump only consists of an SPDT switch with one switch output going to the micropro cessor and the other going to the keyboard encoder The switch has a common input line and two output signal lines The two signal lines are complementary such that one line is always logic high and the other is always low When the Remote Dose Cord button is pressed both signal lines change to the alternate logic state This redundancy prevents a single line failure from starting a dose delivery The button allows the pump to be placed in a very low power mode by turning off all sensors and LCD but some battery energy is still used by the electronics To maximize battery life remove the batteries when pump is not in use Data Memory in Real Time Clock RAM Many settings of the pump s delivery and record keeping parameters are stored by the microprocessor in a Battery backed RAM in the Real Time Clock Data to and from the memory is presented serially Whenever the microproces sor uses data from the Real Time Clock the data is checked for validity 12 EEPROM Data describing the current delivery protocol is stored in an EEPROM included in the micro processor Whenever this data is used it is checked for validity Battery Backed RAM Additional settings of the pump s delivery and record keeping paramete
25. cantly at very low operating temperatures For example at 0 C 32 F an alkaline battery will yield approximately 30 of its normal capacity Alkaline batteries do not need to be stored in a refrigerator After four years of storage at 21 C 70 F an alkaline battery retains approxi mately 86 of its original capacity Battery life will be shorter if the battery is stored above room temperature An alkaline battery stored at 43 C 110 F will be down to approximately 80 of its capacity within one year Recommended storage conditions are 10 C to 25 C 50 F to 77 F with no more than 65 relative humidity noncondensing The following table may be used to predict typical alkaline battery life at different delivery rates when alkaline batteries are used in the CADD Legacy pump As expected battery life decreases as the delivery rate increases This table is based on laboratory tests using fresh DURACELL alkaline batteries in CADD Legacy pumps while the pumps were operating at room temperature Actual battery life may be significantly shorter depending on the operating temperature and the storage conditions of the battery Continuous Delivery Battery Life with Alkaline Batteries Rate Life Volume 0 4 ml hr 338 hrs 4 ml hr 178 hrs 10 ml hr 112 hrs 15 ml hr 96 hrs 30 ml hr 53 hrs 75 ml hr 18 hrs 125 ml hr 15 hrs 135 ml 712 ml 1120 ml 1440 ml 1590 ml 1350 ml 1875 ml Table 5 Two AA Al
26. ck button e Thread the tubing through the air detector groove Start the pump e Deliver a demand dose NOTE Five min utes must have passed since the delivery of the last demand dose e The pump should deliver the dose without an air detection alarm Upstream Occlusion Sensor Test e Verify that the Upstream Occlusion Sensor is turned on See page 23 To Access Biomed Functions Loop Obtain a CADD Administration Set with bag spike and anti siphon valve Also obtain a clamp slide clamp or hemostat Insert the CADD Administration Set spike into an appropriate standard IV bag filled with water Attach the cassette to the pump Prime the entire fluid path Program the pump to deliver a continuous maximum rate Press and hold to start the pump Clamp the tubing halfway between the IV bag and the pump The pump should alarm within three activations after clamping the tubing Occlusion Pressure Range Tests Occlusion Pressure Range Test I Description Pressure is generated by activating the pump ing mechanism with an attached filled clamped Medication Cassette Reservoir The pump is started and a Demand Dose is given until the high pressure alarm sounds Equipment needed 50 or 100 ml Medication Cassette containing distilled water TM Reservoir Procedure 1 Insert two AA batteries and wait for the pump to power up 2 Attach a Medication Cassette Reservoir containing water to
27. ct a single bubble greater than 0 250 ml Multi bubble Sensing The air detector is also designed to sense if an accumulation of more than 1 ml of air has passed through the outlet tubing path in the last 15 minutes This feature is active anytime the air detector is on The air detector is compatible with all of the Medication Cassette Reservoirs and CADD Administration Sets indicated for use with the CADD Legacy pump and all pump accessories It is powered directly from the pump and no additional power is required Theory of Operation The air detector consists of sensor electronics and two ultrasonic transducers positioned on oppo site sides of the fluid path One transducer acts as an acoustic transmitter and the other as an acoustic receiver Air detection occurs when air in the fluid path causes a reduction in the signal level to the receiver When the signal is inter rupted for a preset length of time the sensing circuitry sends a signal to the microprocessor indicating air in the fluid path To maximize the reliability of the system and to reduce false alarms the transmitted signal is swept over a frequency range This accommodates varying resonance frequencies of the transducer and reduces sensitivity to tubing tolerances and other mechanical variations 15 Downstream Occlusion Sensor The downstream occlusion sensor is designed to detect excessive pressure in the outlet tubing If the fluid path t
28. ct with the sensor In order to conserve battery power the upstream occlusion sensor circuit is only activated while the motor circuitry is enabled Pressure on the sensor is read just prior to the motor starting and after the end of the motor stroke The microprocessor uses an average of the pressure exerted by the unoccluded tubing to establish a baseline pressure If the tubing pressure at the end of a motor stroke is below the baseline pressure the upstream tubing is occluded Cassette Attachment Detection The pump uses the upstream occlusion sensor and cassette present sensor to verify the pres ence of a cassette If an infusion is started by pressing when there is no cassette installed or if a cassette is improperly seated the pump will initiate a visual and audible alarm Theory of Operation During manufacture of the pump upstream occlusion sensor readings are recorded for no cassette installed and typical cassette installed These readings are used to calculate threshold levels for cassette detection When a cassette is first attached to the pump the new sensor reading must be above the calculated threshold level Additional readings are taken periodically while the pump is in use If the sensor readings drop below the threshold when the motor is off or the cassette present sensor circuit does not sense the presence of a cassette the cassette is considered removed Safety Features and Fault Detection
29. cy Delivered Delivery Volume Error Error Volume ml ml 40 Deltec SIMS 1261666 Inc St Paul MN 55112 U S A ms SMITHS INDUSTRIES BEREM Medical Systems CADD CADD Legacy Medication Cassette and Medication Cassette reservoir design are SIMS trademarks The products described are covered by one or more of the following U S Patent Nos 4 559 038 4 565 542 4 650 469 5 364 242 5 531 697 5 538 399 5 540 561 5 564 915 5 567 119 5 567 136 5 647 854 5 695 473 Japanese Patent No 2034590 European Patent No 0182502 other patent s pending foreign patents s pending DURACELL is a registered trademark of DURACELL Inc Energizer is a registered trademark of EVEREADY Battery Company Inc SaniCloth is a registered trademark of PDI 2000 SIMS Deltec Inc All rights reserved Printed in U S A 1 00 19876 ISO 9001 Registered C 6
30. e clock time This battery must be replaced by SIMS Deltec Inc The internal battery has an expected life of 5 years System Operating Temperature 2 C to 40 C 35 F to 104 F System Storage Temperature 20 C to 60 C 4 F to 140 F System Delivery Accuracy 6 nominal System is defined as a CADD Legacy pump with an attached Medication Cassette Reservoir and CADD Extension Set with High Pressure Alarm 26 14 psi 1 79 0 97 bar Air Detector Alarm Single bubble Low sensitivity greater than 0 250 ml High sensitivity greater than 0 100 ml Multi bubble 1 0 ml nominal Delivery Mode Specifications CADD Legacy PCA pump Reservoir Volume 1 to 9999 or Not In Use programmable in 1 ml increments displayed in 0 1 ml increments Default 1 ml Units Milliliters ml milligrams mg micro grams mcg Default milligrams Concentration Mg ml 0 1 0 2 0 3 0 4 0 5 1 2 3 4 5 10 15 95 100 Default 100 mg ml Mcg ml 1 2 3 4 5 10 15 95 100 200 300 400 500 Default 500 mcg ml Continuous Rate 0 to 50 ml hr or the mg or mcg equivalent See Table 1 for scroll ranges Demand Dose 0 to 9 9 ml in 0 05 ml increments or the mg or mcg equivalent See Tables 2 and 3 for scroll ranges Delivery rate Continuous Rate Demand Dose 125 ml hr nominal Dose Lockout 5 minutes to 24 hours in the following increments 1 minute for values between 5 and 20 minutes
31. e of the system The manufacturer shall not be responsible for any incidental damages or consequential damages to property loss of profits or loss of use caused by any defect or malfunction of the system If you wish to receive additional information about the extent of the warranty on these prod ucts please contact your Deltec representative or call Customer Service at 1 800 426 2448 All recommendations information and litera ture supplied by Deltec with respect to the CADD product line are believed to be accurate and reliable but do not constitute warranties No agent representative or employee of Deltec has authority to bind Deltec to any representa tion or warranty expressed or implied Exposure to Radiation Ultrasound or Magnetic Resonance Imaging MRI or use near ECG equipment CAUTION e Do not expose the pump to therapeutic levels of ionizing radiation as permanent damage to the pump s electronic circuitry may occur The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions If the pump must remain in the vicinity during a therapy session it should be shielded and its ability to function properly should be confirmed following treatment e Do not expose the pump directly to ultrasound as permanent damage to the pump s electronic circuitry may occur Do not use the pump in the vicinity of magnetic resonance imaging MRI equipment as mag netic f
32. e to 20 ml Now press 2 This value is the intended delivery volume Remove the slide clamp With the pump in Lock Level 0 program a continuous rate of 50 ml hr Start the pump and deliver 20 ml Again secure the slide clamp as close as possible to end of the CADD Extension Set luer lock connector Remove the Medication Cassette Reservoir from the pump and weigh the entire Medication Cassette Reservoir CADD Extension Set assembly This is the post delivery weight Calculate the difference in weight between the pre delivery weight and the post delivery weight This is the weight of the amount delivered 1 ml of water at 20 weighs 1 gram Find the difference between the volume of the amount delivered and the intended delivery volume This is the inaccuracy volume Divide the inaccuracy volume by the in tended delivery volume and multiply by 100 This is the accuracy error percentage See Table 11 10 If the accuracy error percentage is greater than 6 repeat the test with a new Medi cation Cassette Reservoir If the pump fails a second time call Deltec s Customer Service Department Pre Post Weight of Intended Inaccuracy Accuracy Accuracy Delivery Delivery Amount Delivery Volume Error Error Percentage Weight Weight Delivered Volume 61 1 g 41 6 19 5 g 19 5 ml 20 ml 0 5 ml 0 5 ml 20 0 ml 0 025 x 100 2 5 0 025 Table
33. ensor must show that half a revolu tion has occurred within four seconds and that the motor has stopped when half a rotation was completed In addition no camshaft rotation can take place when the motor has not been commanded to run Power Circuitry Power for the pump is normally supplied by two AA alkaline batteries two AA lithium batteries or an AC adapter These types of batteries have a fairly low internal resistance over their discharge range which will keep power supply noise low Other types of batter ies such as carbon zinc exhibit high internal resistance especially near depletion A voltage drop across the internal resistance occurs when current is drawn by the motor during pump activations This current is demanded in short pulses when the motor is first turned on and Pump Housing Expulsor Occlusion Sensor Cassette Hinge Pump Tubing generates large spikes in the battery voltage This noise can cause the low battery detection circuit to shut down the pump The power from the two AA batteries is boosted to 5VDC This 5V is used to power the motor and a 3 3V linear regulator The linear regulator provides power to all the other circuitry including the microprocessor Voltage Reference Circuit A voltage reference circuit provides a constant DC voltage to the microprocessor Analog to Digital Converter ADC By reading this input and comparing the value to a predetermined range the microprocess
34. g not running Hardware reset occurs Pump continues to indicate depleted battery condition Table 9 CADD Legacy pump low battery conditions Cassette Present Sensor Circuit The cassette present sensor system consists of a switch on the pump mechanism that interfaces to the attached cassette and associated cir cuitry This switch senses the presence of a cassette When a cassette is latched to the pump the cassette presses against the switch in the pump mechanism Electronic circuitry on the circuit board detects this and reports the information to the microprocessor This system acts as a safety feature to detect a damaged or detached cassette If during operation the microproces sor detects the switch open the pump will enable audible and visual alarms and stop delivery Redundancy with the upstream occlusion sensor prevents single fault failures from causing over or under delivery of fluid Addi tional circuitry allows these sensors to be turned on and off by the microprocessor to conserve battery power Voltage Detector Circuit Low voltage detection is performed by part of the watchdog circuit and by the microproces sor via software Three low voltage levels are detected The first two levels Low Battery and Battery Depleted are detected by software and the third by hardware The first level to be reached is the Low Battery Warning threshold which occurs when the battery voltage decays to a nominal value of 2
35. ication Cassette Reservoir containing water CAUTION At the completion of the test the pressure must be reduced to zero before detaching the cassette from the pump otherwise the cassette may rupture Safety glasses should be worn while conducting or observing this test Procedure 1 Insert two AA batteries and wait for the pump to power up TM 2 Attach a Medication Cassette Reservoir to the pump Lock the cassette NOTE The pressure from the source must be zero when the cassette is attached 3 Assemble the apparatus as shown in Figure 11 4 Connect the Medication Cassette Reservoir outlet tube to the metered pressure source NOTE Do not use a CADD Extension Set with Anti siphon Valve 5 Program the pump for a continuous rate of 50 ml hr Press 9 6 Slowly increase the back pressure noting when the high pressure alarm is activated NOTE The pressure may be increased rapidly to 8 psi 0 55 bar after which the pressure should be increased at 3 psi min 0 21 bar min or less until the alarm sounds 7 The high pressure alarm should sound within 1 79 0 97 bar or 26 14 psi Testing Procedures CADD Legacy PCA pump continued Accuracy Testing Gravimetric Accuracy Testing Description A Medication Cassette Reservoir is partially filled with water and weighed The cassette is then attached to the pump and the pump is set to deliver a certain amount of
36. ields may adversely affect the operation of the pump Remove the pump from the pa tient during MRI procedures and keep it at a safe distance from magnetic energy e Do not use the pump near ECG equipment as the pump may interfere with the operation of the equipment Monitor ECG equipment care fully when using this pump 1 2 CADD Legacy Pump Delivery Modes The CADD Legacy ambulatory drug delivery pump provides measured drug therapy to patients in hospital or outpatient settings The CADD Legacy pump is indicated for intrave nous intra arterial subcutaneous intraperi toneal epidural space or subarachnoid space infusion Epidural administration is limited to use with indwelling catheters for short term delivery of anesthetics and short or long term delivery of analgesics Subarachnoid administration is limited to use with indwelling catheters for short term delivery of analgesics Clinician Bolus used here as a loading dose Demand Doses Continuous Rate Figure 1 PCA mode delivery profile Delivery Rate CADD Legacy PLUS ML HR or CADD Legacy 1 ML 24 HR Continuous Delivery Figure 2 Continuous mode delivery profile Dose Cycle gt Dose Duration Duration a Time Intermittent Delivery Figure 3 Intermittent mode delivery profile 2 The CADD Legacy PCA pump may be programmed to deliver medication in one of three ways 1 continuous r
37. imately sixty six seconds and ten activations later the Reservoir Volume alarm should occur The display should show Reservoir Volume Empty DOSE Key Check CADD Legacy PCA pump only Check the key operation by program ming the pump with the following values Reservoir Volume 10 0 ml Units Milliliters Continuous Rate 0 0 ml hr Demand Dose 1 00 ml Dose Lockout 00 hrs 5 min Doses Per Hour 12 Doses Given 0 doses Press to clear 0 doses Press to clear 0 00 ml Press to clear Press and hold 8 The pump should sequentially display all of the programmed values Doses Attempted Given After RUN appears on the display press and note the time The pump should beep twice and begin to deliver Count the number of pump activations The pump should make ten double activations After ten double activations the display should show a Reservoir Volume of 9 0 ml Press s two more times within the next 5 minutes The pump should not deliver Remote Dose Cord Check CADD Legacy PCA pump only Wait 5 minutes after the dose given above then instead of pressing press the button on the Remote Dose Cord The pump should make ten double activations After ten double activations the display should show a Reservoir Volume of 8 0 ml Press Testing Procedures CADD Legacy PCA pump continued the Remote Dose Cord button two more times within the next 5 minutes The pump should
38. ir bubbles for this test 4 Close the slide clamp on the distal end of the tubing near the female luer of the Medication Cassette Reservoir 5 Program the pump to the following param eters Reservoir Volume 10 0 ml Continuous Rate 3000 0 ml 24hr Given 0 0 ml Press to clear 6 Start the pump When the pump is running note when the high pressure alarm is acti vated PSI EES Regulator Pressure Gauge Figure 12 Occlusion test set up 7 The pump should alarm when the pump delivers between 1 and 2 activations Occlusion Pressure Range Test II Description An adjustable metered pressure source is connected to the Medication Cassette Reser voir tubing The pressure is slowly increased until the high pressure alarm sounds Equipment needed e Pressure gauge 40 psi 1 psi 2 76 bar 0 07 bar e Pressure vessel partially filled with water e Pressure regulator 40 psi 2 76 bar 0 07 bar e 50 or 100 ml Medication Cassette Reser voir containing water CAUTION At the completion of the test the pressure must be reduced to zero before detaching the cassette from the pump otherwise the cassette may rupture Safety glasses should be worn while conducting or observing this test Procedure 1 Insert two AA batteries and wait for the pump to power up TM 2 Attach a Medication Cassette the pump Lock the cassette Reservoir
39. ishing documentation of cleaning and func pump If service is required fill out this sheet and return it with the device Serial Reference Number Date Refer to the Technical Manual procedures I Cleaning Completed II Visual Inspection LCD Occlusion Sensor Seals Valves and Expulsor Cassette Hinge Area Cassette Lock HI Mechanical Inspection Keypad Battery Door IV Functional Inspection Power up Cassette Lock Cassette Sensor LCD Motor Gear Train Yes No Cassette Sensor Accessory Jack Keypad Air Detector Indicator Light Pump Housing Power Jack Battery Door Battery Compartment Cassette Lock Reservoir Volume Empty Alarm Dose Given Attempted PCA Starting Stopping MG Given Given Activation Timing Air Detector Dose Key PCA Remote Dose Cord PCA V Downstream Occlusion Pressure Range Tests Test 1 Activations Before Alarm Test 2 High Pressure Alarm At psi VI Accuracy Testing Volumetric Accuracy Test Intended Actual Delivery Delivery Volume Volume Inaccuracy Accuracy Accuracy Volume Error Error Percentage Gravimetric Accuracy Test Pre Delivery Post Delivery Weights Weight Amount Intended Inaccuracy Accuracy Accura
40. ive noise or grinding sounds Count the number of pump activa tions The pump should prime ten double activations and then stop Press to return to the main menu Reservoir Volume Empty Alarm Check Program the Reservoir Volume to 1 0 ml Press and hold until three series of dashes appear Release eme Press and hold eme The pump should prime ten double activations and then stop The pump will alarm and display Reservoir Volume Empty Press Qer 29 Testing Procedures CADD Legacy 1 pump continued Starting Stopping the Pump Program the pump with the following values Reservoir Volume 1 0 ml Rate 3000 ml 24hrs Given 0 0 ml press to clear Program the Air Detector Off Press and hold QH Starting appears followed by three sets of dashes each ac companied by a beep A review of the programmed parameters then appears The main screen should appear with RUN in the display To stop the device press and hold G Stopping appears followed by three sets of dashes that disappear one at a time each accompanied by a beep The main screen should appear with STOPPED in the display Activation Timing Check Reprogram the Reservoir Volume to 1 0 and clear the Given screen Press and hold until three dashes disappear from the display The pump should sequentially display all of the pro grammed values Start a timer at the first motor activation Count the activations One
41. kaline type batteries used with the CADD Legacy pumps 8 Intermittent Delivery Battery Life with Alkaline Batteries Dose Volume Duration Dose Cycle KVO Volume 23 5 ml 1 00 hr 5 00 hr 0 2 ml hr 61 ml 1 00 hr 6 00 hr 0 2 ml hr 125 ml 1 00 hr 6 00 hr 0 2 mi hr Table 6 Two AA Alkaline type batteries used with the CADD Legacy pumps 915 ml 1224 ml 1356 ml 135 120 105 90 75 60 45 30 15 Rate ml hr 10 20 30 40 50 60 Hours 100 Figure 5 Operating time to low battery alarm using alkaline batteries Rate ml hr oOo NA OQO 50 100 150 200 Hours 250 300 350 Figure 6 Operating time to low battery alarm using alkaline batteries Continuous Delivery Battery Life with Lithium Batteries Rate Life Volume 0 4 ml hr 413 hrs 165 ml 4 ml hr 307 hrs 1228 ml 10 ml hr 190 hrs 1900 ml 15 ml hr 163 hrs 2445 ml 30 ml hr 90 hrs 2700 ml 75 ml hr 33 hrs 2475 ml 125 ml hr 22 hrs 2750 ml Table 7 Two AA Lithium type batteries used with the CADD Legacy pumps Intermittent Delivery Battery Life with Lithium Batteries Dose Volume Duration Dose Cycle KVO Life Volume 23 5 ml 1 00 hr 5 00 hr 0 2 ml hr 300 hrs 1458 ml 61 ml 1 00 hr 6 00 hr 0 2 ml hr 185 hrs 1911 ml 125 ml 1 00 hr 6 00 hr 0 2 ml hr 125 hrs 2625 ml Table 8 Two AA Lithium type batteries used with the CADD Legacy pumps 135 120 105 90 75 60 45 30 15 0 Ra
42. main menu Reservoir Volume Empty Alarm Check Program the Reservoir Volume to 1 0 ml Press until Reservoir Volume is dis played on the LCD Press N or y until 1 0 ml is displayed Then press E Press and hold until three series of dashes appear Release eme Press and hold rme The pump should prime ten double activations and then stop The pump will alarm and display Reservoir Volume Empty Press er Starting Stopping the Pump Program the pump with the following values Reservoir Volume 1 0 ml Units milliliters Continuous Rate 50 ml hr Demand Dose 0 00 ml Given 0 00 Press amp Program the Air Detector Off Press and hold G Starting appears followed by three sets of dashes each ac companied by a beep A review of the programmed parameters then appears The main screen should appear with RUN in the display To stop the device press and hold G Stopping appears followed by three sets of dashes that disappear one at a time each accompanied by a beep The main screen should appear with STOPPED in the display 24 Activation Timing Check Reprogram the Reservoir Volume to 1 0 and clear the Given screen Press and hold until three dashes disappear from the display The pump should sequentially display all of the pro grammed values Start a timer at the first motor activation Count the activations One activation should occur every six seconds Approx
43. metric Accuracy Testing Description A predetermined amount of water is delivered into a collection device such as a burette or graduated cylinder The amount of water delivered is compared to the amount that the pump should have delivered Nominal system accuracy is given in the technical specifications section for the pump That is under the test conditions described below the accuracy of the pump and Medica tion Cassette Reservoir will be nominal with a 90 confidence level The nominal test conditions are as follows degassed water at 25 5 C without back pressure Equipment needed e 50 or 100 ml Medication Cassette Reser voir e 50 or 60 ml syringe e CADD Extension Set with Anti siphon Valve e A fluid collection device such as a burette or a class A 25 ml capacity graduated cylinder e 40 ml of room temperature water NOTE The test procedure calls for the use of a Medication Cassette Reservoir and a CADD Extension Set with Anti siphon Valve An IV bag and CADD Admini stration Set with integral or add on anti siphon valve can be substituted for the Medication Cassette Reservoir and CADD Extension Set with Anti siphon Valve Procedure 1 Fill the 50 or 60 ml syringe with 40 ml of water Transfer the water into a Medication Cassette Reservoir 2 Remove any air from the Medication Cassette Reservoir by aspirating the air with the syringe Attach the CADD Exten sion Se
44. microprocessor causes the pump mechanism to deliver fluid pulses timed according to the desired rate At rates of 15 ml hr or less the microprocessor delivers a single pulse to the motor circuit causing a half revolution of the camshaft and fluid delivery in 0 05 ml increments At rates greater than 15 ml hr the microprocessor delivers two back to back pulses to the motor circuit causing a full revolution of the camshaft and fluid delivery in 0 1 ml increments Thus to deliver 20 ml hr for example the micropro cessor solves these equations Mechanism activations per hr 20 ml per hr 0 1 ml per activation 20 0 1 200 Time seconds between activations 3600 sec per hr number of activations per hr 3600 200 18 NOTE At rates 15 ml br the pump delivers 0 05 ml per stroke This allows a more contin uous delivery at low rates The microprocessor uses its timer circuits to accurately time the 18 seconds in this ex ample between mechanism activations The timebase accuracy is ultimately determined by the 3 6864 MHz quartz crystal oscillator Air Detector The air detector is designed to detect air in the outlet tubing fluid path The air detector can be set to On high sensitivity On low sensitivity or Off by accessing Biomed Functions When the On high sensitivity setting is selected the pump will detect a single bubble greater than 0 100 ml When the On low sensitivity setting is selected the pump will dete
45. mp should issue an audible alarm and the display should read No Disposable Clamp Tubing Press or vem to silence the alarm Press and hold to turn the pump off The following three checks LCD Motor and Gear Train and Reservoir Volume Empty Alarm Check should be performed in the sequence shown LCD Check e With the pump turned off press Ea The second screen that the pump displays will consist of 32 blocks of characters Examine the LCD to verify that there are no missing dark pixels in the character blocks Motor and Gear Train Check e Program the Reservoir Volume to 2 0 e Program Biomed to Continuous Mode Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Percentage Volume Volume 20 ml 19 5 ml 0 5 ml 0 5 ml 20 0 ml 0 025 0 025 x 100 2 5 Table 14 Volumetric percentage calculation 34 Testing Procedures CADD Legacy PLUS pump continued e Attach either a 50 or 100 ml Medication Cassette Reservoir or CADD Administra tion Set to the pump Lock the cassette e Press and hold until three series of dashes appear Release Pre Press and hold rane While priming the pump listen to the motor for excessive noise or grinding sounds Count the number of pump activa tions The pump should prime ten double activations and then stop Press to return to the main menu Reservoir Volume Empty Alarm Check e Program the Reservoir Vol
46. mps are sealed units A broken or damaged seal will therefore be considered conclusive evidence that the pump has been misused and or altered which voids any and all warranties All service and repair of CADD Legacy pumps must be performed by Deltec or its author ized agents Cleaning Use any of the following solutions to clean the pump and accessories Soap solution Benzalkonium chloride concentrate 0 13 Glutaral concentrate USP 2 10 percent solution of household bleach one part household bleach to nine parts water Alcohol USP 93 Isopropyl Alcohol USP 99 PDI Super Sani Cloth Mada Medical MadaCide 70 Chlorohexine 1 Dampen a soft lint free cloth with cleaning solution Apply the solution to exterior surface of the pump or accessory Do not allow the solution to soak into the pump or accessory 2 Wipe the entire surface dry with another soft lint free cloth Allow the pump to dry completely before use CAUTION Do not immerse the pump in cleaning fluid or water Do not allow solution to soak into the pump accumulate on the keypad or enter the battery compart ment Moisture build up inside the pump may damage the pump e Do not clean the pump with acetone other plastic solvents or abrasive cleaners as damage to the pump may occur Battery Contact Cleaning Pump battery contact cleaning can be per formed easily using a clean cotton swab wetted with Isopropyl Alcohol
47. nd anti siphon valve Also obtain a clamp slide clamp or hemostat Insert the CADD Administration Set spike into an appropriate standard IV bag filled with water Attach the cassette to the pump Prime the entire fluid path Program the pump to deliver a continuous maximum rate Press and hold to start the pump Clamp the tubing halfway between the IV bag and the pump The pump should alarm within three activations after clamping the tubing Occlusion Pressure Range Tests Occlusion Pressure Range Test I Description Pressure is generated by activating the pump ing mechanism with an attached filled clamped Medication Cassette Reservoir The pump is started until the high pressure alarm sounds Equipment needed 50 or 100 ml Medication Cassette Reservoir containing distilled water Procedure 1 Insert two AA batteries and wait for the pump to power up 2 Attach a Medication Cassette Reservoir containing water to the pump Lock the cassette 3 Prime the Medication Cassette Reservoir tubing The tubing should be filled with fluid to the end of the luer lock connector The system must be free from air bubbles for this test 4 Close the slide clamp on the distal end of the tubing near the female luer of the Medication Cassette Reservoir 36 5 Program the pump to the following param eters Reservoir Volume 10 0 ml Continuous Rate 125 0 ml hr Given 0 0 ml Press to clear 6
48. not deliver Doses Given and Doses Attempted Check CADD Legacy PCA pump only Stop the pump by pressing and holding G Use to advance to the Doses Given screen The screen should show 2 Use Qer to advance to the Doses Attempted screen The display should show 6 If the above steps have not been followed exactly differ ent values may appear GIVEN Mode Check e Press Cer to advance to the Given screen The display should now show 2 00 ml If the above steps have not been followed exactly a different value may appear Press the key The display should now show 0 00 ml Air Detector Test This test will verify the function of the air detector To perform this test the air detector must be turned on The previous program from the key check can be used to perform this test e Attach an empty Medication Cassette Reservoir or CADD Administration Set to the pump e Secure it using the lock button e Thread the tubing through the air detector groove Start the pump e The pump should respond with a continuous two tone alarm and the display should read Air In Line Detected e Press wer or to silence the alarm and remove the Medication Cassette Reservoir or CADD Administration Set e Now attach a Medication Cassette Reser voir containing fluid or a primed CADD Administration Set to the pump Make certain there is no air in the fluid path e Secure it using the lo
49. o the patient becomes blocked the pump tubing will expand as pumping occurs When there has been an amount of inflation corresponding to 179 3 kPa 96 5 kPa 1 79 0 97 bar or 26 14 psi the occlusion sensor trips whereupon the microprocessor stops the pump mechanism and issues visual and audible alarms Thus the maximum pressure which can be developed is 276 kPa 2 76 bar 40 psi Construction The downstream occlusion sensor consists of a membrane switch located on the bottom of the pump next to the outlet valve The switch is fastened to the housing with an adhesive to ensure that the overall assembly is water resistant Theory of Operation The membrane switch is in contact with the outlet tubing when a cassette is installed Tubing expansion caused by a downstream occlusion results in closure of the membrane switch Switch closure sends a logic low to the microprocessor indicating a downstream occlusion Upstream Occlusion Sensor The upstream occlusion sensor detects an occlusion in the inlet tubing which would prevent or restrict the flow of fluid to the pump 16 Construction The upstream occlusion sensor consists of a strain gauge sensor located on the bottom of the pump next to the inlet valve The sensor is fastened to the housing with an adhesive to ensure that the overall assembly is water resistant Theory of Operation When a cassette is installed on the pump the inlet tubing is in conta
50. ock level is already LLO press to exit 2 Press 4 or until LLO appears 3 Press again or GS Code 0 will appear 4 Press or until the Lock Level Code 63 appears for CADD Legacy PCA 64 for CADD Legacy 1 or 65 for CADD Legacy PLUS 5 Press or to set the new lock level CADD Legacy PCA Pump Power up Check Insert batteries or press and observe the LCD during power up The first screen will display the serial number model number and software number with revision level The second screen will display 32 character blocks If LEC and four digits appear prior to the pump displaying the 32 charac ter blocks the pump has experienced an electrical or mechanical fault and should be returned for service If no error message is immediately shown the pump has powered up normally The pump will then sequen tially display all of the programmed values and beep at each screen After all screens are displayed successful power up is indicated with six audible beeps and the STOPPED screen displayed Continue with the Lock check To Access Biomed Functions Loop 1 Press Cow The current lock level will appear 2 Press or amp CODE 0 will appear 3 Press N or Y7 until the Biomed function code 163 ap a Code 100 Then press or as Air Detector ON OFF 1 Press wom until Air Detector appears 2 Use or
51. op all drug delivery Keypad Encoder Check Key presses are routed to the microprocessor via a keypad encoder Every time the software receives data from the keypad encoder it is checked If the data is not a valid key press the software disregards it The keypad contains a redundant switch in the key key and key CADD Legacy PCA The redundant switch in each of these keys is routed to the microprocessor via an I O chip The microprocessor must see a valid signal simultaneously from the redundant switch and the normal switch routed through the keypad encoder before it will start infusing Data Handling Software Safety Features Data Stored in RAM Before use data associated with delivery and stored in RAM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data If the stored and calculated CRCs do not match the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Data Stored in EEPROM Before use data associated with delivery and stored in EEPROM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data If the stored and calculated CRCs do not match the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Data Stored in NOVRAM Before use data associated with delivery and stored in NOVRAM is tested b
52. operate the pump and pump operation has stopped Software Safety Features Hardware related Software Safety Features Program Memory Check At power up and at regular intervals thereafter the program memory is tested by calculating a Cyclic Redundancy Code CRC on the program and then comparing it with the CRC stored with the program If the stored and calculated CRCs do not match the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery RAM Memory Check At power up the random access memory is checked A particular bit pattern is written to and read from each address in the RAM If the read data is different from the written data the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Motor Circuit Check At power up and at regular intervals thereafter the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on If the software detects power being applied to the motor at any other time it will sound a continuous two tone audible alarm and will no longer attempt to deliver medication During every pump activa tion the software checks to see whether the motor completes one activation If the motor fails to turn or fails to complete a cycle the software will display a system fault screen turn on a continuous two tone audible alarm and st
53. or y until the Biomed function code 164 appears Lock Code 100 Then press or R Air Detector ON OFF 1 Press wer until Air Detector appears 2 Use AN or y to select Off 3 Press to enter the change Lock Check Attach a 50 or 100 ml Medication Cas sette Reservoir or a CADD Administra tion Set to the pump The slot on the Cas sette Lock button should be aligned with the Locked symbol Cassette Sensor Check Unlock the cassette by inserting a coin into the latch and turning clockwise The pump should issue an audible alarm and the display should read No Disposable Clamp Tubing Press or wer to silence the alarm Press and hold to turn the pump off The following three checks LCD Motor and Gear Train and Reservoir Volume Empty Alarm Check should be performed in the sequence shown LCD Check With the pump turned off press G The second screen that the pump displays will consist of 32 blocks of characters Examine the LCD to verify that there are no missing dark pixels in the character blocks Motor and Gear Train Check Program the Lock Level to LLO Program the Reservoir Volume to 2 0 ml Attach either a 50 or 100 ml Medication Cassette Reservoir or CADD Administra tion Set to the pump Lock the cassette Press and hold until three series of dashes appear Release eume Press and hold me While priming the pump listen to the motor for excess
54. or by using a pre moistened Alcohol swab Use a minimum of 70 concentration by volume Isopropyl Alcohol Do not use Alcohol formulation that has other additives besides Alcohol and water e Using a cotton swab wetted with Alcohol or the pre moistened Alcohol swab rub with medium pressure over the entire contact surface a minimum of ten back and forth cycles twenty total wipes over the contact e Select a fresh surface of the swab and repeat the cleaning process on the second battery contact Dispose of the swab when finished e Using a second Alcohol wetted swab rub over each contact surface again a minimum of four back and forth cycles eight total wipes over the contact Allow the contacts to dry for a few minutes 21 Visual Inspection Visually inspect the pump for any damage to the LCD occlusion sensor seals valves and expulsor cassette hinge area cassette lock cassette sensor keypad indicator light power jack accessory jack air detector and housing If any damage is noted the pump should be returned for service Check the battery door for proper operation It should not be broken or damaged The battery door mating tabs on the pump housing should not be broken or damaged Examine the battery compartment for damage If the battery contacts appear corroded clean them as instructed on page 20 If the battery contacts appear to be bent or pushed in straightening may be possible with a small screwdri
55. or can validate the accuracy of the 3 3 volt power supply Varia tions in the 3 3 volt supply left undetected can result in inaccuracy in the low battery alarm set points and variations in other calculated values Also refer to Voltage Detector Circuit description on page 18 Pumping Mechanism The pumping mechanism is linear peristaltic with two active valves and an expulsor Pump ing occurs when the expulsor presses on the reservoir pump tubing in sequence with the inlet and outlet valves At rest the outlet valve is pressing down fully on the tubing and the expulsor and inlet valve are retracted See Figure 9 Camshaft Lock Cassette Upstream Sensor Pressure Plate Inlet Valve Outlet Valve Figure 9 A simulated pumping mechanism in a CADD Legacy pump 14 When the microprocessor commands the mecha nism to pump the camshaft begins to rotate thus controlling the following pump cycle 1 The inlet valve closes 2 In synchrony with the expulsor moving down to compress the tubing the outlet valve opens expelling 0 050 ml of fluid toward the patient 3 The outlet valve closes 4 The inlet valve opens as the expulsor is retracted causing fluid from the reservoir to again fill the pump tubing segment 5 The camshaft rotation stops after half a revolution and the cycle is completed Pumping Characteristics To deliver the amount of drug specified by the parameter settings the pump s
56. quarter turn counter clockwise NOTE The Medication Cassette Reservoir and the administration set are intended for single use only The keyboard located on the front housing is composed of eight membrane switches nine membrane switches on the CADD Legacy PCA pump and is sealed against moisture All of the keys contain domes to provide a tactile feel when the key is pressed The keyboard keys are sensed by the pump s microprocessor The Liquid Crystal Display LCD also located on the front housing shows the pump status and programmed settings The dot matrix display consists of 16 character columns with 2 rows of characters and is selected by the pump s microprocessor according to status conditions and keyboard entries The microprocessor and other circuitry which control the pump are located on a printed circuit board The board contains the Central Processing Unit CPU motor driver circuitry and other circuitry The circuitry is designed to reduce susceptibility to interference from electromagnetic fields and to dissipate electro static discharge The LCD controller is mounted on the LCD using chip on glass technology The pumping mechanism subassembly contains the motor gear train camshaft valves expul sor sensing disk infrared light source infrared detector occlusion sensors disposable sensor and cassette locking button Via the motor driver circuitry the pump s microprocessor controls mo
57. r Press GH 6 Slowly increase the back pressure noting when the high pressure alarm is activated NOTE The pressure may be increased rapidly to 8 psi 0 55 bar after which the pressure should be increased at 3 psi min 0 21 bar min or less until the alarm sounds 7 The high pressure alarm should sound within 1 79 0 97 bar or 26 14 psi Accuracy Testing Gravimetric Accuracy Testing Description A Medication Cassette Reservoir is partially filled with water and weighed The cassette is then attached to the pump and the pump is set to deliver a certain amount of water The cas sette is then removed and weighed again The amount of water delivered is compared to the amount that the pump should have delivered Nominal system accuracy is given in the techni cal specifications section for the pump That is under the test conditions described below the accuracy of the pump and Medication Casssette Reservoir will be nominal with a 90 confidence level The nominal test condi tions are as follows degassed water at 25 5 C without back pressure Equipment needed e 50 or 100 ml Medication Cassette Reservoir 50 or 60 ml syringe 40 Q PSI i Regulator Pressure Gauge Figure 13 Occlusion test set up e CADD Extension Set with Anti siphon Valve e A balance accurate to 0 1 g 40 ml of room temperature water Procedure 1 Fill the 50 o
58. r 60 ml syringe with 40 ml of water Transfer the water into a Medication Cassette Reservoir 2 Remove any air from the Medication Cassette Reservoir by aspirating the air with the syringe Attach the CADD Exten sion Set with Anti siphon Valve Prime the tubing so it is filled with fluid to the end of the CADD Extension Set luer lock connector 3 Weigh the entire Medication Cassette Reservoir CADD Extension Set assembly and record the weight This is the pre delivery weight This weight includes the empty Medication Cassette Reservoir CADD Extension Set and weight of the water 4 Attach the Medication Cassette Reservoir to the pump Program the reservoir volume to 20 ml Now press Ge This value is the intended delivery volume Remove the slide clamp 5 With the pump in Lock Level 0 program a continuous rate of 125 ml hr Start the pump and deliver 20 ml 6 Again secure the slide clamp as close as possible to end of the CADD Extension Set luer lock connector Remove the Medication Cassette Reservoir from the pump and weigh the entire Medication Cassette Reservoir CADD Extension Set assembly This is the post delivery weight 7 Calculate the difference in weight between the pre delivery weight and the post deliv ery weight This is the weight of the amount delivered One ml of water at 20 C weighs 1 gram 8 Find the difference between the volume of the amount delivered and
59. rs are stored in a battery backed Random Access Memory RAM Battery backup is provided by a printed circuit board mounted lithium battery This battery provides a minimum of five years of memory retention during normal pump usage Whenever the microprocessor uses data from the RAM the data is checked for validity Time Base Circuitry An accurate 3 6864 MHz timebase is provided by a quartz crystal The 3 6864 MHz signal is connected to the microprocessor where it is frequency divided to access the program memory at a cycle rate of 921 kHz In addition an accurate 32 768 kHz timebase is provided by a second quartz crystal The 32 768 kHz signal is used for the real time clock LCD Circuitry The CADD Legacy pumps feature a 2 line by 16 character Liquid Crystal Display LCD The characters on this dot matrix display are formed by a matrix of 5 by 7 dots It is reflec tive only with a black on silver appearance with no backlight The display includes a controller chip mounted directly on the glass capable of interfacing with 4 and 8 bit systems to display 92 kinds of characters numerals symbols and special characters under control of a built in character generator ROM A RAM is also included to make other special characters possible LED Indicator A green Light Emitting Diode LED is pro vided under the pump s front panel overlay to provide pump power status to the user When this LED is lit it indica
60. t with Anti siphon Valve Prime the tubing so it is filled with fluid to the end of the CADD Extension Set luer lock connector 3 Insert the end of the CADD Extension Set into the fluid collection device 4 Attach the Medication Cassette Reservoir to the pump Program the Reservoir Volume to 20 ml This is the intended delivery volume Remove all clamps 5 Program a continuous rate of 3000 ml 24hr Start the pump and deliver 20 ml 6 When delivery is complete record the volume of fluid delivered This is the actual delivery 7 Find the difference between the volume of the amount delivered and the intended delivery volume This is the inaccuracy volume 8 Divide the inaccuracy volume by the in tended delivery volume and multiply by 100 This is the accuracy error percentage See Table 14 9 If the accuracy error percentage is greater than 6 repeat the test with a new Medication Cassette Reservoir If the pump fails a second time call Deltec s Customer Service Department 33 Example Actual Delivery Volume 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml Intended Delivery Volume 20 0 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 CADD Legacy PLUS Pump Power up Check e Insert batteries or press and observe the LCD during power up The first screen will display the serial number model number and soft
61. te ml hr 20 40 60 80 100 120 140 160 180 200 Hours Figure 7 Dual stroke operating time on lithium batteries 18 16 14 12 1 Rate ml hr ON DD DO O 50 100 150 200 250 300 350 400 450 Hours Figure 8 Single stroke operating time on lithium batteries 10 Construction The pump s housing is made of a special high impact plastic It is composed of two sections the rear and front housing The pump housing is sealed to ensure that the pump is water resistant The battery compartment is not water resistant NOTE The CADD Legacy ambulatory infusion pump is water resistant but not waterproof The pump is Splashproof and is characterized by the IEC code of 14 The battery compartment is accessed through a removable door on the rear housing Within the battery compartment is space for the batteries and the four battery contacts On CADD Legacy pumps the Medication Cassette Reservoir or the administration set is attached to the bottom of the pump by inserting the two hooks on the cassette into the mating hinge pins on the pump The pump and the reservoir or the administration set are then placed in an upright position on a firm flat surface The reservoir or the administration set must be secured in place by inserting a coin or key if using the CADD Legacy PCA pump in the slot on the pump s locking button pushing the button in and turning the button one
62. tes that an AC adapter is being used to power the pump Flash PROM Technology Program memory for the pump is stored in Flash Programmable Read Only Memory Flash PROM This type of memory allows modification of the contents without physically removing the device from the circuit board Under certain circumstances the program can also be downloaded Several layers of redun dancy in the programming system prevent accidental erasing or modification of the PROM Audible Alarm Circuitry Audible alarm circuitry consists of two piezo electric disks and an independent oscillator The disks flex or bend in resonance with the output of the oscillator The piezo disks are mounted to the pump housing to enhance sound level The microprocessor controls the audible alarm by selecting the alarm control line for more than 0 5 seconds The oscillator which drives the piezo disks is capable of providing two driving frequencies The low frequency is in the range of 700 to 1500 Hz and the high fre quency is in the range of 1600 to 2500 Hz When the microprocessor selects the audible alarm the alarm enters a warble mode where it oscillates between the low and high frequency sound at a rate of 0 8 and 2 Hz Low battery voltage detection and watchdog timer circuitry also have the ability to enable the audible alarm via the microprocessor The audible alarm circuitry is backed up by a super capacitor The super capacitor provides energy for
63. the intended delivery volume This is the inaccuracy volume 37 Testing Procedures CADD Legacy PLUS pump continued 9 Divide the inaccuracy volume by the in tended delivery volume and multiply by 100 This is the accuracy error percentage See Table 15 10 If the accuracy error percentage is greater than 6 repeat the test with a new Medication Cassette Reservoir If the pump fails a second time call Deltec s Customer Service Department Example Predelivery Weight 61 1 Postdelivery Weight 68 Weight of Amount Delivered 19 5 g 19 5 ml Volume of Amount Delivered 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml Intended Delivery Volume 20 0 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 Equipment needed 50 or 100 ml Medication Cassette Reser voir 50 or 60 ml syringe CADD Extension Set with Anti siphon Valve A fluid collection device such as a burette or a class A 25 ml capacity graduated cylinder 40 ml of room temperature water NOTE The test procedure calls for the use of a Medication Cassette Reservoir and a CADD Extension Set with Anti siphon Valve An IV bag and CADD Admini stration Set with integral or add on anti siphon valve can be substituted for the Medication Cassette Reservoir and CADD Extension Set with Anti siphon Valve Procedure 1 Fill the 50 or 60 ml
64. the pump Lock the cassette 25 Testing Procedures CADD Legacy PCA pump continued 3 Prime the Medication Cassette Reservoir tubing The tubing should be filled with fluid to the end of the luer lock connector The system must be free from air bubbles for this test 4 Close the slide clamp on the distal end of the tubing near the female luer of the Medication Cassette Reservoir 5 Program the pump to the following param eters Reservoir Volume 10 0 ml Units Milliliters Continuous Rate 0 00 ml hr Demand Dose 1 00 ml Dose Lockout 00 hrs 5 min Doses Per Hour 12 Dose Given 0 Press to clear Dose Attempts 0 Press to clear Milligrams Given 0 00 ml Press to clear 6 Start the pump When the pump is running activate a Demand Dose noting when the high pressure alarm is activated 7 The pump should alarm when the pump delivers between 1 and 2 activations Occlusion Pressure Range Test II Description An adjustable metered pressure source is connected to the Medication Cassette Reser voir tubing The pressure is slowly increased until the high pressure alarm sounds 2 PSI Regulator Pressure Gauge Figure 11 Occlusion test set up 26 Equipment needed e Pressure gauge 40 psi gt 1 psi 2 76 bar 0 07 bar e Pressure vessel partially filled with water e Pressure regulator 40 psi 2 76 bar 0 07 bar e 50 or 100 ml Med
65. tion that would allow the patient complete access to all programming and operating functions Improper programming could result in death or serious injury to the patient IMPORTANT NOTICE CADD Legacy PCA CADD Legacy 1 and CADD Legacy PLUS pump operations and safety features are based on a microcomputer design Inadequate servicing or tampering with the safety features of the pumps may seriously affect performance and safety For that reason ALL SERVICING AND REPAIR OF THE CADD Legacy PUMPS MUST BE PERFORMED BY DELTEC OR ITS AUTHORIZED AGENTS The manufacturer s warranty agreement shall become null and void if the pump is not used in accordance with the Operator s Manual and Instructions for Use for the pump accessories or the pump is serviced by persons other than Deltec or those authorized by Deltec Limited Warranty The limited warranty associated with the CADD Legacy PCA CADD Legacy 1 and CADD Legacy PLUS pumps can be found in the product literature supplied with the product when originally purchased which is incorpo rated herein by reference DELTEC SPECIFI CALLY DISCLAIMS ANY OTHER WAR RANTY WHETHER EXPRESS IMPLIED OR STATUTORY INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR USE Deltec further disclaims responsibility for the suitability of the system for a particular medical treatment or for any medical complica tions resulting from the us
66. to NOTE The pressure from the source must be zero when the cassette is attached 3 Assemble the apparatus as shown in Figure 12 4 Connect the Medication Cassette Reser voir outlet tube to the metered pressure source TM NOTE Do not use a CADD Extension Set with Anti siphon Valve 5 Program the pump for_a continuous rate of 3000 ml 24hr Press GR 6 Slowly increase the back pressure noting when the high pressure alarm is activated 31 Testing Procedures CADD Legacy 1 pump continued NOTE The pressure may be increased rapidly to 8 psi 0 55 bar after which the pressure should be increased at 3 psi min 0 21 bar min or less until the alarm sounds Procedure ik Fill the 50 or 60 ml syringe with 40 ml of water Transfer the water into a Medication Cassette Reservoir 2 Remove any air from the Medication 7 The high pressure alarm should sound Cassette Reservoir by aspirating the air within 1 79 0 97 bar or 26 14 psi with the syringe Attach the CADD Exten sion Set with Anti siphon Valve Prime the tubing so it is filled with fluid to the end of Accuracy Testing the CADD Extension Set luer lock connec Gravimetric Accuracy Testing oe 3 Weigh the entire Medication Cassette Description Reservoir CADD Extension Set assembly A Medication Cassette Reservoir is partially and record the weight This 1s the pre filled with water and weighed The
67. to select Off 3 Press to enter the change Lock Check e Attach a 50 or 100 ml Medication Cas sette Reservoir or a CADD Administra tion Set to the pump The mark on the Cassette Lock button should be aligned with the Locked symbol Cassette Sensor Check e Unlock the cassette by inserting a key into the lock and turning clockwise The pump should issue an audible alarm and the display should read No Disposable Clamp Tubing e Press or wer to silence the alarm Press and hold to turn the pump off The following three checks LCD Motor and Gear Train and Reservoir Volume Empty Alarm Check should be performed in the sequence shown LCD Check e With the pump turned off press G The second screen that the pump displays will consist of 32 blocks of characters Examine the LCD to verify that there are no missing dark pixels in the character blocks 23 Testing Procedures CADD Legacy PCA pump continued Motor and Gear Train Check Program the Reservoir Volume to 2 0 ml Attach either a 50 or 100 ml Medication Cassette Reservoir or CADD Administra tion Set to the pump Lock the cassette Press and hold until three series of dashes appear Release eume Press and hold eme While priming the pump listen to the motor for excessive noise or grinding sounds Count the number of pump activa tions The pump should prime ten double activations and then stop Press to return to
68. tor rotation Two external port connectors are utilized for remote dose and external power input The accessory jack is used for attachment of the Remote Dose Cord CADD Legacy PCA pump only and interface cable The Remote Dose Cord enables the patient to use either of two options to begin a Demand Dose when using the PCA delivery mode 1 the Remote Dose button or 2 the key The second port allows connection to an AC adapter The keyboard is connected to the printed circuit board via a flex circuit tail Discrete wires connect the pumping mechanism motor and sensors to the printed circuit board The accessory jack in conjunction with the interface cable allows download of events using the CADD DIPLOMAT software 11 Theory of Operation Keyboard Circuitry The CADD Legacy pumps are controlled by a microprocessor The actions of the microproces sor are controlled by a program which is contained in the memory Commands are issued to the microprocessor from the user via the eight keys on the keyboard nine keys and Remote Dose Cord on CADD Legacy PCA pump The keys on the keyboard are arranged in a 3x3 matrix which feeds into the keyboard encoder A key closure applies a ground to the associated input of the keyboard encoder Key debounce circuitry resident in the keyboard encoder provides a clean output signal to the microprocessor for the duration of the key closure The micropro cessor reads key
69. uld now show 1 00 mil If the above steps have not been followed exactly a different value may appear Press the key The display should now show 0 00 ml Air Detector Test This test will verify the function of the air detector To perform this test the air detector must be turned on The previous program from the Activation Timing Check can be used to perform this test 1 Attach an empty Medication Cassette Reservoir or CADD Administration Set to the pump Secure it using the lock button Thread the tubing through the air detector groove Start the pump The pump should respond with a continuous two tone alarm and the display should read Air in Line Detected Press wer or to silence the alarm and remove the Medication Cassette Reservoir or CADD Administration Set Now attach a Medication Cassette Reser voir containing fluid or a primed CADD Administration Set to the pump Make certain there is no air in the fluid path Secure it using the lock button Thread the tubing through the air detector groove Program the Reservoir Volume to 1 0 ml Start the pump The pump should deliver without an air detection alarm 35 Testing Procedures CADD Legacy PLUS pump continued Upstream Occlusion Sensor Test e Verify that the Upstream Occlusion Sensor is turned on See page 34 To Access Biomed Functions Loop Obtain a CADD Administration Set with bag spike a
70. ume to 1 0 ml e Press and hold until three series of dashes appear Release eme Press and hold eme The pump should prime ten double activations and then stop The pump will alarm and display Reservoir Volume Empty Press er Starting Stopping the Pump e Program the pump with the following values Reservoir Volume 1 0 ml Rate 125 ml hr Given 0 0 ml press to clear e Program the Air Detector Off e Press and hold 6 Starting appears followed by three sets of dashes each ac companied by a beep A review of the programmed parameters then appears The main screen should appear with RUN in the display e To stop the device press and hold G Stopping appears followed by three sets of dashes that disappear one at a time each accompanied by a beep The main screen should appear with STOPPED in the display Activation Timing Check e Reprogram the Reservoir Volume to 1 0 and clear the Given Screen e Press and hold until three dashes disappear from the display The pump should sequentially display all of the pro grammed values Start a timer at the first motor activation Count the activations One activation should occur every three seconds Approximately twenty seven seconds and ten activations later the Reservoir Volume alarm should occur The display should show Reservoir Volume Empty GIVEN Mode Check Press wer to advance to the Given screen The display sho
71. utton is a Single Pole Double Throw SPDT switch which operates in the same manner as the key When the Remote Dose Cord is attached to the pump the patient may press either the Remote Dose button or the 8 key to receive a Demand Dose The clinician may also use either the Remote Dose button or the key to deliver a clinician activated bolus For easy access the Remote Dose Cord may be fastened to the patient s clothing or bedsheet with the attached clip There is an alarm function present in the CADD Legacy PCA pump If the Remote Dose Cord is removed the display shows a message Remote Dose Removed The pump sounds an audible alarm until the key is pressed to acknowledge the alarm NOTE To detach the Remote Dose Cord from the pump grasp the Remote Dose Cord connector and pull back using a straight steady motion Batteries Battery Compatibility Recommended Batteries Two AA alkaline batteries are recommended for use in the CADD Legacy pumps Carbon zinc mercury nickel cadmium nickel metal hydride or zinc air AA batteries should not be used Battery Life The CADD Legacy pumps have been de signed to provide optimal battery life The expected battery life in the CADD Legacy pumps depends on the following factors Programmed delivery rate Operating temperatures e Battery type and brand e Battery age DURACELL Alkaline Battery Life Battery life is shortened signifi
72. ve An IV bag and CADD Admini stration Set with integral or add on anti siphon valve can be substituted for the Medication Cassette Reservoir and CADD Extension Set with Anti siphon Valve Procedure 1 Fill the 50 or 60 ml syringe with 40 ml of water Transfer the water into a Medication Cassette Reservoir 2 Remove any air from the Medication Cassette Reservoir by aspirating the air with the syringe Attach the CADD Exten sion Set with Anti siphon Valve Prime the tubing so it is filled with fluid to the end of the CADD Extension Set luer lock connec tor 3 Insert the end of the CADD Extension Set into the fluid collection device TM 4 Attach the Medication Cassette Reservoir to the pump Program the Reservoir Volume to 20 ml This is the intended delivery volume Remove all clamps 5 Program a continuous rate of 50 ml hr Start the pump and deliver 20 ml 6 When delivery is complete record the volume of fluid delivered This is the actual delivery 7 Find the difference between the volume of the amount delivered and the intended delivery volume This is the inaccuracy volume 8 Divide the inaccuracy volume by the in tended delivery volume and multiply by 100 This is the accuracy error percentage See Table 12 Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Percentage Volume Volume 20 ml 19 5 ml 0 5 ml 0 5 ml 20 0 ml
73. ver or other suitable tool Care must be taken not to damage the pump housing or to incur further damage to the contacts 22 Mechanical Inspection e Press each key on the keypad Each key should have a distinctive dome feeling The keys should not feel flat e Attach the battery door The battery door should fit snugly in place when it is closed on the pump e Attach either a 50 ml or 100 ml Medication Cassette Reservoir or a CADD Adminis tration Set to the pump Using a coin key for the CADD Legacy PCA pump turn the lock 1 4 turn counter clockwise Check for smooth operation and a definite feel when the lock pulls the cassette firmly against the bottom of the pump The slot on the cassette lock should be aligned with the LOCKED indicator on the side of the pump e Gently twist and pull on the cassette to make sure it is firmly attached Testing Procedures Testing Recommendation Deltec recommends annual functional testing on the CADD Legacy pumps The following testing procedures should be performed annu ally to verify function and accuracy NOTE To perform the following functional tests the pump must be in Lock Level 0 Changing to Lock Level 0 LLO Before programming the pump make sure the lock level is 0 LLO allows the operator to access all programming and operating func tions 1 Make sure the pump is stopped Press oer The current lock level will appear If the l
74. ware number with revision level The second screen will display 32 character blocks If LEC and four digits appear prior to the pump displaying the 32 charac ter blocks the pump has experienced an electrical or mechanical fault and should be returned for service If no error message is immediately shown the pump has powered up normally The pump will then sequen tially display all of the programmed values and beep at each screen After all screens are displayed successful power up is indicated with six audible beeps and the STOPPED screen displayed Continue with the Lock check To Access Biomed Functions Loop 1 Press Cow The current lock level will appear 2 Press or Gm CODE 0 will appear 3 Press AN or y until the Biomed function code 165 appears Lock Code 100 Then press or GB Air Detector ON OFF 1 Press Cer until Air Detector appears 2 Use or to select Off 3 Press to enter the change Changing Delivery Modes 1 Press om until Delivery Mode appears 2 Press or v to select Continuous 3 Press to enter the change Lock Check e Attach a 50 or 100 ml Medication Cas sette Reservoir or a CADD Administra tion Set to the pump The slot on the Cas sette Lock button should be aligned with the Locked symbol Cassette Sensor Check e Unlock the cassette by inserting a coin into the lock and turning clockwise The pu
75. water The cassette is then removed and weighed again The amount of water delivered is compared to the amount that the pump should have deliv ered Nominal system accuracy is given in the techni cal specifications section for the pump That is under the test conditions described below the accuracy of the pump and Medication Cassette Reservoir will be nominal with a 90 confi dence level The nominal test conditions are as follows degassed water at 25 5 C without back pressure Equipment needed e 50 or 100 ml Medication Cassette voir TM Reser e 50 or 60 ml syringe e CADD Extension Set with Anti siphon Valve e A balance accurate to 0 1 g e 40 ml of room temperature water Procedure 1 Fill the 50 or 60 ml syringe with 40 ml of water Transfer the water into a Medication Cassette Reservoir 2 Remove any air from the Medication Cas sette Reservoir by aspirating the air with the syringe Attach the CADD Extension Set with Anti siphon Valve Prime the tubing so it is filled with fluid to the end of the CADD Extension Set luer lock connector 4 Weigh the entire Medication Cassette Reservoir CADD Extension Set assembly and record the weight This is the pre delivery weight This weight includes the empty Medication Cassette Reservoir CADD Extension Set and weight of the water Attach the Medication Cassette Reservoir to the pump Program the reservoir volum
76. y calculating a CRC on the data and then comparing it with the CRC stored with the data If the stored and calculated CRCs do not match the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Data Used in Calculations Calculations on data used in some way to control the delivery of drug are performed redundantly The two calculated values are then compared If the two values do not match the software will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Timer Data Registers The data in the timer Real Time Clock is checked at regular intervals If the data is not reasonable the software will turn on a con tinuous two tone audible alarm and stop all drug delivery 19 Hardware and Software Fault Detection Overview If the CADD Legacy pump displays an error code a hardware or software fault has been detected by the microprocessor and the pump should be returned for servicing When hardware or software faults are detected by the microprocessor pump operation stops and a continuous two tone audible alarm will be activated An error message will be dis played on the LCD On the next power up the error code will again be displayed If the error detected was a data fault the pump will be in Lock Level 2 and all other programmed functions will have default values See the pump s Operator

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