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CADD-Prizm-6100-6101-Tech-manual

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Contents

1. LCD Lock Data In Out Jack Occlusion Sensor Seals Cassette Sensors 3 Air Detector or Port Cover Valves and Expulsors Keyboard Pump Housing Reservoir Hinge Area Indicator Light Battery Door Latch Power Jack Battery Compartment HI Mechanical Inspection Keyboard Cassette Latch Battery Door Cassette Lock IV Functional Inspection Power up RES VOL Alarm Dose Given Attempted Latch Lock Stop Start MG Given Cassette Sensor Activation Timing Air Detector LCD Dose Key Printer Tests Motor Gear Train Remote Dose Cord V Occlusion Tests Only need to perform 1 or 2 not both Downstream Option 1 Activations Before Alarm Downstream Option 2 High Pressure Alarm At psi Upstream Occlusion Sensor Test Pass Fail VI Accuracy Testing Only need to perform 1 or 2 not both Volumetric Accuaracy Test Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Volume Volume Percentage Gravimetric Accuracy Test Pre Delivery Post Delivery Amount Intended Inaccuracy Accuracy Accuracy Weights Weight Delivered Delivery Volume Error Error Volume ml ml Customer amp Clinical Services 1 800 426 2448 U S amp Canada www deltec com Deltec Deltec Inc St Paul MN 55112 USA CADD CADD Prizm and Medication Ca
2. CADD pumps 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 pumps must be performed by Deltec or its authorized agents Cleaning 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 compartment e Do not allow solution to enter the data in out jack or the power jack Make sure the jack covers are closed before cleaning e Do not expose the open air detector port area of the pump or the connector opening on the air detector to foreign material moisture or cleaning fluids If an air detector is not installed on the pump make sure the air detector port cover is securely attached before cleaning e Do not clean the pump with acetone other plastic solvents or abrasive cleaners Use any of the following solutions to clean the pump and accessories e Soap solution e Benzalkonium chloride concentrate 0 13 e Glutaral concentrate USP 2 e 10 percent solution of household bleach one part household bleach to nine parts water e Alcohol USP 93 e Isopropyl Alcohol USP 99 e PDI Super Sani Cloth e Mada Medical MadaCide 1 Dampen a soft lint free cloth with cleaning solution Apply the solution to exterior surface of the pump or acces
3. MODEL 6101 MODEL 6100 This online version differs Deltec from the printed version Certain information that is not intended for patients has been removed 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 24 hours a day with the programming and operation of CADD pump infusion systems The issue date of this Technical Manual is included for the user s information In the event one year has elapsed between the issue date and product use the user should contact Deltec Inc to see if a later revision of this manual is available Issue Date April 2002 Table of Contents TEE ICHION esinsin iia 1 Limited Warranty cccccccssscccesscceesseceeeeeeeees 1 Exposure to Radiation or Magnetic Resonance Imaging MRI sccsscccssetccecssscssactastenseseoohseeessves 1 CADD Prizm Putin py aisicisetchcs tied Seen 2 Delivery Modes ccccssccsssssceeseecssseeeseseeceees 2 Specifications Nominal ccccesccesseeeeeeeees 5 Batteries soeren sire ea aeiee 8 Battery Compatibility 0 0 0 eeesssceseeceteeenees 8 DURACELL Alkaline Battery Life 8 ULTRALIFE Lithium Battery Life 8 C nstr cti
4. cates an upstream occlusion Safety Features and Fault Detection Hardware Safety Features Key hardware safety features include a watch dog timer circuit motor driver and motor watchdog circuits cassette type sensor circuit latch lock sensor circuit and a voltage detector circuit Each safety circuit performs a unique function to insure the overall safety of the device See Figure 8 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 PROGRAM MEMORY MB LCD DISPLAY CPU IO KEYBOARD Figure 8 CADD Prizm pump hardware block diagram GATE ARRAY 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 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 microprocessor can force a watchdog time out After being reset the microprocesso
5. LL1 or LL2 Time 00 00 to 23 59 Air Detector Turned On or Turned Off Event Log 0 to 500 events Extended History Up to 48 hours in 1 hour increments Biomed Toolbox Specifications Micrograms On or Off Extended History On or Off Max Dose per Hour On or Off PCA software rev 6210G or higher only PM Preventive Maintenance Reminder 1 to 24 months in 1 month increments Not In Use Custom Lock Level Code Date Format US Standard mm dd yy or European Standard dd mm yy Power Source Display Always display or only Low Battery Upstream Sensor On or Off Model 6101 only Air Detector Required Required or Not Required Compatible Reservoirs and Administration Sets e 50 ml or 100 ml Medication Cassette reser voir used with the CADD extension set with anti siphon valve e CADD administration set with integral anti siphon valve with or without bag spike allows use of flexible plastic bag or sterile vial with injector e CADD administration set with add on anti siphon valve and bag spike allows for gravity priming before attaching the add on anti siphon valve e CADD Prizm high volume administration set with add on anti siphon valve with or without air eliminating filter Remote Dose Cord Deltec provides a Remote Dose Cord for the PCA delivery mode which is an extension of the DOSE key The push button switch is a Single Pole Double Throw SPDT which operates in the same
6. Table 4 PCA delivery mode Demand dose clinician bolus scroll ranges milliliters Specifications Nominal General Pump Specifications Resolution Medicaton Cassette reservoir or CADD administration set 0 050 ml pump stroke nominal CADD Prizm high volume administration set 0 100 ml pump stroke nominal Size 4 4 cm x 10 4 cm x 14 1 cm 1 7 in x 4 1 in x 5 6 in excluding cassette or other accessories Weight 568 g 20 oz including 9 volt battery and empty 100 ml Medication Cassette reservoir excluding other accessories Pump Alarms Low battery power depleted battery power external power source low faulty depleted pump stopped pump fault low reservoir volume high delivery pressure air in line air detector faulty or detached only with the use of the optional air detector air detector port cover detached delivery too slow key stuck cassette detached or unlocked print failure upstream occlusion model 6101 only Bolus Volume at Occlusion Alarm Pressure 0 050 ml resolution sets reservoirs lt 0 25 ml 0 100 ml resolution sets lt 2 0 ml Power Sources 9 volt alkaline or lithium battery such as DURACELL Alkaline MN 1604 or ULTRALIFE Lithium U9VL Power Pack reorder number 21 3801 AC adapter An internal battery powers the clock When it is depleted it cannot reliably maintain the clock time This battery must be replaced by the manufacturer The internal battery has an expected l
7. 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 driver 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 sensor must show that half a revolu tion has occurred within five 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 a 9 volt alkaline battery 9 volt lithium battery or AC adapter These types of batteries have a fairly low internal resistance over their dis charge range which will keep power supply noise low Other types of batteries 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 generates large spikes in the battery voltage This noise can cause the low battery detection circuit to shut down the pump The motor driver circuit power is taken di rectly from the battery but the microprocessor and its associated circuitry requires closely regulated and filtered 5 volt pow
8. 2 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 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 reservoir 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 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 extension set with anti siphon valve Prime the tubing so it is filled with fluid to the end of the extension set luer lock connector 3 Attach the end of the extension set to 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 Open all clamps 5 Program a continuous rate of 0 0 ml hr
9. Cassette reservoir tubing The pressure is slowly increased until the high pressure alarm sounds Equipment needed e Pressure gauge 30 psi 1 psi e Pressure vessel partially filled with water e Pressure regulator 30 psi e 50 or 100 ml Medication Cassette reservoir containing water Procedure 1 Insert a battery and wait for the pump to power up 2 Attach a Medication Cassette reservoir to the pump Latch and 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 9 oie 30 0 PSI Regulator Pressure Gauge Figure 9 Occlusion test set up 4 Connect the Medication Cassette reser voir outlet tube to the metered pressure source NOTE Do not use a CADD extension set with anti siphon valve 5 Start the pump and run at 30 ml hr 6 Slowly increase the back pressure noting when the high pressure alarm is activated NOTE The pressure may be increased rapidly to 8 psi after which the pressure should be increased at 3 psi min or less until the alarm sounds 7 The high pressure alarm should sound between 9 and 27 psi 189 psi Upstream Occlusion Sensor Test Model 6101 pumps only Description The tubing between the fluid reservoir and the pump is occluded while the pump is running until the occlusion alarm sounds Equip
10. alarm should occur The display should show Reservoir Volume is Zero with a Milligrams Given of 1 0 mg DOSE Key Check Check the DOSE key operation by program ming the pump with the following values Reservoir Volume 10 0 ml Units Milligrams Concentration 1 0 mg ml Continuous Rate 0 0 mg hr Demand Dose 1 0 mg Demand Dose Lockout 0 hrs 5 min Max Doses Per Hour 12 Dose Counters 0 0 Press the ENTER key to clear 0 0 mg Press the ENTER key to clear Press the STOP START key Press the Y key The pump should sequentially display all of the programmed values After RUNNING appears on the display press the DOSE key 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 the DOSE key two more times within the next 5 minutes The pump should not deliver and the message Dose Not Deliv ered Dose Locked Out should be displayed Milligrams Given Remote Dose Cord Check if applicable Wait 5 minutes after the dose given above then instead of pressing the DOSE key 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 the DOSE key two more times within the next 5 minutes The pump should not deliver
11. and the message Dose Not Deliv ered Dose Locked Out should be displayed Doses Given and Doses Attempted Check Stop the pump by pressing the STOP START key then the Y key Use the NEXT key to advance to the Dose Counters screen The display should show 2 6 if the DOSE key and Remote Dose cord were tested If only the DOSE key was tested the display will show 1 3 If the above steps have not been followed exactly different values may appear 25 e Press the ENTER key The display should now show 0 0 MG GIVEN Mode Check e Press the NEXT key to advance to the Milligrams Given screen The display should now show 2 0 mg if the DOSE key and Remote Dose cord were tested If only the DOSE key was tested the display will show 1 0 If the above steps have not been followed exactly different values may appear Press the ENTER key The display should now show 0 0 mg Air Detector Test if applicable This test will verify the function of the optional air detector To perform this test the CADD Prizm pump must have an air detector installed and the air detector must be turned on The previous program from the DOSE key check page 26 can be used to perform this test e Attach an empty Medication Cassette reservoir or CADD administration set to the pump Latch and lock the set to the pump e Open the air detector door and thread the tubing through the groove Close the door making sure the tubing does
12. attempt to deliver medication During every pump activation 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 turn on a continuous two tone audible alarm and stop all drug delivery Keyboard Encoder Check Every time the software receives data from the keyboard encoder it is checked If the data is not of the proper form the software will turn on a continuous two tone audible alarm and stop all drug delivery The DOSE key has two independent signal lines to prevent single fault failures 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 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 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 by calculating a CRC on the data and then comparing it with the CRC stored wit
13. not get pinched or kinked Start the pump The pump should respond with a continuous two tone alarm and the display should read Air in line detected Pump will not run Next to silence Press NEXT to silence the alarm and re move the Medication Cassette reservoir or CADD administration set e Now attach a Medication Cassette reservoir containing fluid and a primed extension set with anti siphon valve or a primed CADD administration set with anti siphon valve to the pump Make certain there is no air in the fluid path 26 e Latch and lock the set to the pump e Open the air detector door and thread the tubing through the groove e Close the door making sure the tubing does not get punched or kinked e Start the pump e Deliver a demand dose NOTE five minutes must have passed since the delivery of the last demand dose e The pump should deliver the dose without an air detection alarm Occlusion Accuracy Tests This manual provides two testing options for the Occlusion Pressure Range Test and the Accuracy Test Only one option needs to be performed It is not necessary to perform both Option 1 and Option 2 Downstream Occlusion Pressure Range Test Option 1 Description Pressure is generated by activating the pumping 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 neede
14. 00 hr 5 ml hr 6333 ml 5833 ml Table 10 9 volt Lithium type batteries used with the CADD Prizm pump Volume Period Taper Up Taper Down KVO Volume 1 00 hr 1 00 hr 5 ml hr 2000 10 00 hr 3000 10 00 hr 1 00 hr 1 00 hr 5 ml hr 12777 ml 13498 ml Table 11 EPS System used with the CADD Prizm pump 10 Construction The pump s housing is made of a special high impact plastic designed to reduce interference from electromagnetic fields and to dissipate electrostatic discharge It is composed of two sections the base and cover housing The pump housing is sealed to ensure that the pump is water resistant The battery compart ment is not water resistant NOTE The CADD Prizm ambulatory infusion pump is water resistant but not waterproof The battery compartment is accessed through a removable door on the side of the base hous ing Within the battery compartment is space for the battery and the two battery contacts 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 administra tion set are then placed in an upright position on a firm flat surface The reservoir or the administration set can be latched in place by inserting a coin in the slot on the pump s latching button pushing the button in and turning the button one quarter tu
15. CADD Prizm pump As expected battery life decreases as the delivery rate increases These tables are based on laboratory tests using fresh DURACELL alkaline batteries in CADD Prizm 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 Battery life is shortened significantly 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 tables are based on laboratory tests conducted at room temperature using fresh DURACELL alkaline batteries and a CADD administration set Actual battery life will vary depending on the brand of battery battery shelf life and temperature conditions ULTRALIFE Lithium Battery Life The following tables may be used to predict typical lithium battery life at different delivery ra
16. Delivery IREO aion Rate Ea T optional Time Intermittent Delivery Figure 4 Intermittent mode delivery profile lt lt Infusion Period _4 lt Taper Up Taper Down gt Period Optional Period Optional KVO Rate 5 ML HR INFUSION VOLUME Figure 5 TPN mode delivery profile 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 a regular programmed interval TPN Mode Delivery Profile The TPN total parenteral nutrition delivery mode allows the infusion of nutritional solu tions or other fluids with optional tapering at the beginning and end of infusion and an optional KVO PCA Delivery Mode Scroll Ranges Units Starting Increment Maximum Milliliters 0 10 0 10 30 00 Milligrams amp 10 of Mg only Values between 0 01 and 0 5 0 01 Concentration Micrograms concentration Mcg only Values between 0 1 and 0 5 0 1 x 30 Values between 0 5 and 100 0 1 Values between 100 and 1000 1 0 Values greater than 1000 10 0 Table 1 PCA delivery mo
17. PORTANT NOTICE CADD Prizm pump operations and safety features are based on a microcomputer design Inadequate servicing or tampering with the safety features of the pump may seriously affect performance and safety For that reason ALL SERVICING AND REPAIR OF THE CADD Prizm PUMP 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 Prizm pump 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 compli cations resulting from the use 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 th
18. a definite feel when the latch pulls the reservoir or administration set firmly against the bottom of the pump The mark on the latch should be aligned with the solid dot Lock the device by inserting a key into the lock and turn counterclockwise until the mark lines up with the solid dot Gently twist and pull on the cassette to make sure it is firmly attached NOTE In the PCA delivery mode the cassette must be locked in order to start the pump 22 9 Testing Procedures Functional Testing The Power up Check Latch Lock Check and Cassette Sensor Check using a Medication Cassette reservoir or CADD administration set can be performed with the pump in any of the four delivery modes The Cassette Sensor Check using the CADD Prizm high volume administration set can be performed in any delivery mode except the PCA delivery mode Power up Check e Insert a battery in the pump and observe the LCD during power up R code Pump model number CADD PRIZM 61 K lec KARR Sh ARARA 8254 4 620 AARAA ARAR A Terminal Serial number Software revision level The number values may vary depending on the current mode and software revision e If lec XXXXX last error code with 5 digit number appears on the display prior to the pump reviewing the current program settings the pump has experienced an electrical or mechanical fault and should be returned for service If no error message is immedia
19. air detector and will automatically turn the sensor on when powered up in LLO When the optional air detector is installed the Biomed Toolbox feature allows the air detector to be required or not required When the air detector is not required it can be turned on or turned off using the Options menu When the air detector is required the option for turning the air detector on or off will not be available When the air detector is turned on the pump will detect the presence of air in the outlet tubing fluid path If the air detector settings are not required and turned off it will default to turned on each time the pump powers up in Lock Level 0 The air detector is compatible with all of the reservoirs and sets indicated for use with the CADD Prizm pump and all pump accessories It is powered directly from the CADD Prizm pump and no additional power is required Specifications The air detector will alarm when it senses a single air bubble greater than 100 microliters 0 1 milliliters Construction The air detector housing is made of a special high impact plastic and has a metalized film coating on the inside surface to reduce interfer ence from electromagnetic fields The air detector is composed of a single base compartment with a detachable door It is sealed against the pump housing to ensure the overall assembly is water resistant The air detector is mounted to the pump hou
20. and a Demand Dose of 1 0 ml but do not deliver a Demand Dose Start the pump and deliver a clinician bolus of 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 29 delivery volume This is the inaccuracy volume Divide the inaccuracy volume by the intended delivery volume and multiply by 100 This is the accuracy error percentage See Table 15 9 If the accuracy error percentage is greater than 6 repeat the test with a new reservoir If the pump fails a second time call Deltec s Customer Service Department Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Percentage Volume Volume 20 ml 19 5 ml 0 5 ml 0 5 20 0 ml 0 025 0 025 x 100 42 5 Table 15 Volumetric percentage calculation 30 CADD Prizm Pump Cleaning and Functional Testing Checklist The following checklist is provided as a guide only to assist in establishing documentation of cleaning and functional testing for the CADD Prizm pump If service is provided fill out this sheet and return it with the device Serial Reference Number Date Refer to the Technical Manual procedures I Cleaning Completed Yes No II Visual Inspection
21. atter 12 ies These batteries are designed to provide 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 high impedance low power special drive signals for the liquid crystal display are provided by the LCD drivers Each alpha or numeric character on the LCD is formed by darkening combinations of dots Commands to display dots are issued via data bus commands to the LCD drivers by the microprocessor The LCD circuit also contains a power supply which provides bias voltage to the LCD panel This voltage controls the relative brightness of the characters Additional circuitry allows the microprocessor to disable the LCD when not in use in order to conserve battery power A two brightness level LCD backlight is provided to improve LCD viewing under low light conditions When the microprocessor enables the LCD it also enables the low brightness backlight Low brightness is used to conserve battery power If the AC adapter is connec
22. ch a 50 or 100 ml Medication Cassette reservoir to the pump Latch the cassette to the pump The display should show Reser voir latched NOTE The message displayed depends on the type of reservoir or adminis tration set attached See Table 13 e Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot The display should show Cassette Locked e Unlock the cassette The display should show Cassette Unlocked Unlatch the cassette The display should show Cassette Unlatched Close Clamp To Prevent Free Flow 23 Remove the 50 or 100 ml reservoir and attach a CADD administration set to the pump Latch the cassette to the pump The display should show Admin Set Latched e Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot The display should show Cassette Locked Unlock the cassette The display should show Cassette Unlocked Unlatch the cassette The display should show Cassette Unlatched Close Clamp To Prevent Free Flow e Remove the administration set and attach a CADD Prizm high volume administration set to the pump excludes PCA delivery mode Latch the cassette to the pump The display should show High Volume Admin Set Latched Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up w
23. ch type of administration set designed to work with the CADD Prizm pump contains a unique code programmed into the set via nubs molded into the plastic When a set is latched to the pump the nubs press against the pins in the pump mechanism in a pattern unique to that set type Optical detectors and electronic circuitry on the circuit board encode this pattern and report the information to the microprocessor This feature allows automatic rate selection dependent on the type of set attached This system also acts as a safety feature to detect a damaged or detached set If during operation the microprocessor detects all pins extended the pump will enable audible and visual alarms and stop delivery Redundancy in the pattern prevents single fault failures from causing over or under delivery of fluid Additional circuitry allows these sensors to be turned on and off by the microprocessor to conserve battery power Additionally control of sensor power allows the microprocessor to test the sensor inputs in both the powered and unpowered states thus allowing detection of sensor fault conditions Care should be taken not to damage these sensor pins 18 Latch Lock Sensor Circuit Latch and Lock sensors allow the microproces sor to detect the positions of the latch and lock buttons This prevents attempted fluid delivery when the set is not correctly latched to the pump In addition it allows the microprocessor to stop fluid deliv
24. d 50 or 100 ml Medication Cassette reservoir containing water Procedure 1 Insert a battery and wait for the pump to power up 2 Attach a Medication Cassette reservoir contain ing water to the pump Latch and 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 5 Program the pump to the following param eters Reservoir Volume 10 0 ml Units Milligrams Concentration 1 0 mg ml Continuous Rate 0 0 mg hr Demand Dose 1 0 mg Demand Dose Lockout 0 hrs 5 min Max Doses Per Hour 12 Dose Counters 0 0 Press the ENTER key to clear 0 0 mg Press the ENTER key to clear 6 Start the pump When the pump is running activate a Demand Dose noting when the high pressure alarm is activated Milligrams Given 7 The pump should alarm when the pump delivers between 1 and 2 activations 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 Downstream Occlusion Pressure Range Test Option 2 Description An adjustable metered pressure source is connected to the Medication
25. d and the Remote Dose cord The keys on the keyboard feed individually into the Gate Array on the microprocessor board A key closure applies a ground to the associated input of the Gate Array Key debounce cir cuitry resident in the Gate Array provides a clean output signal to the microprocessor for the duration of the key closure The micropro cessor reads keyboard status by accessing special memory locations in the Gate Array The Remote Dose button consists of an SPDT switch with its own dedicated input to the microprocessor circuitry 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 button is pressed both signal lines change to the alternate logic state This redundancy prevents a single line failure from starting a dose delivery Data Memory EEPROM Many settings of the pump s delivery and record keeping parameters are stored by the microprocessor in an Electrically Erasable Programmable Read Only Memory EEPROM Data to and from the memory is presented serially Whenever the microproces sor uses data from the EEPROM the data is checked for validity Battery Backed RAM Additional settings of the pump s delivery and record keeping parameters are stored in a battery backed Random Access Memory RAM Battery backup is provided by two printed circuit board mounted lithium b
26. de continuous rate scroll ranges Micrograms Concentration Demand Dose Clinician Bolus mcg ml increment max increment max 0 05 9 9 0 05 20 0 10 19 8 0 10 40 0 15 29 7 0 15 60 0 20 39 6 0 20 80 0 25 49 5 0 25 0 50 99 0 0 50 200 0 75 148 5 0 75 300 1 00 198 0 1 00 400 1 25 247 5 1 25 500 1 50 297 0 1 50 600 1 75 346 5 1 75 700 2 00 396 0 2 00 800 2 25 445 5 2 25 900 2 50 495 0 2 50 2 75 544 5 2 75 3 00 594 0 3 00 3 25 643 5 3 25 3 50 693 0 3 50 3 75 742 5 3 75 4 00 792 0 4 00 4 25 841 5 4 25 4 50 891 0 4 50 4 75 940 5 4 75 5 00 990 0 5 00 10 00 1980 0 10 00 15 00 2970 0 15 00 20 20 BE Br 4 75 940 5 4 75 5 00 999 0 5 00 Table 3 Demand dose clinician bolus scroll ranges micrograms Milligrams Concentration Demand Dose Clinician Bolus mg ml increment max increment max 0 1 0 01 0 99 0 01 0 02 1 98 0 02 0 03 2 97 0 03 0 04 3 96 0 04 0 05 4 95 0 05 0 05 9 9 0 05 0 10 19 8 1 10 0 15 29 7 1 15 0 20 39 6 0 20 0 25 49 5 0 25 0 50 99 0 0 50 0 75 148 5 0 75 1 00 198 0 1 00 1 25 247 5 1 25 1 50 297 0 1 50 1 75 346 5 1 75 2 00 396 0 2 00 2 25 445 5 2 25 2 50 495 0 2 50 2 75 544 5 2 75 3 00 594 0 3 00 3 25 643 5 3 25 3 50 693 0 3 50 3 75 742 5 3 75 4 00 792 0 4 00 4 25 841 5 4 25 Table 2 Demand dose clinician bolus scroll ranges milligrams Milliliters Demand Dose Clinician Bolus increment max increment max 0 05 9 9 0 05 20
27. e warranty on these prod ucts please contact your Deltec representative or call Customer Service at 800 426 2448 All recommendations information and litera ture supplied by Deltec with respect to the CADD product line are believed to be accu rate and reliable but do not constitute warran ties No agent representative or employee of Deltec has authority to bind Deltec to any representation or warranty expressed or implied Exposure to Radiation or Magnetic Resonance Imaging MRI CAUTIONS 1 The pump SHOULD NOT BE DIRECTLY IRRADIATED by therapeutic levels of ionizing radiation because of the risk of permanent damage to the pump s electronic circuitry The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions or diagnostic levels of radiographic and fluoroscopic radiation If the pump must remain in the vicinity during a diagnostic or therapy session it should be shielded and its ability to function properly should be confirmed following treatment 2 Magnetic fields produced by magnetic resonance imaging MRI equipment may adversely affect the operation of the pump Remove the pump from the patient during MRI procedures and keep it at a safe distance from magnetic energy CADD Prizm Pump Delivery Modes The Deltec CADD Prizm pump provides measured drug therapy to patients in hospital or outpatient settings The CADD Prizm pump is indicated
28. ect the Concentra tion of 1 0 mg and press the ENTER key Select the Continuous Rate of 30 0 mg hr then press the ENTER key Select the Demand Dose of 0 0 mg then press the ENTER key Clear the Milligrams Given register by press ing the ENTER key Milligrams Given Motor and Gear Train Check e Attach either a 50 or 100 ml Medication Cassette reservoir or CADD administration set to the pump Latch and lock the cassette Select Prime from the Options menu by pressing the OPTIONS key then the ENTER key Now press and continue to hold the Y key The pump should begin to prime While priming the pump listen to the motor for excessive noise or grinding sounds Count the number of pump activations The pump should prime ten double activations and then stop The display should show Continue Priming Press Y or N Press the N key Then press the NEXT key twice until the Reservoir Volume screen appears The reser voir volume should show 1 0 ml Reservoir Volume is Zero Alarm Check e Press the OPTIONS key and select the Prime function by pressing the ENTER key Repeat priming by pressing and holding the Y key The pump should prime ten double activa tions and then stop The pump will alarm and display Reservoir Volume is Zero Press the NEXT key Reprogram the reservoir volume to 1 0 ml Press the NEXT key until Reservoir Volume is displayed on the LCD Press the Y or N key until 1 0 ml is displayed Then pre
29. er of Error Code Events c scccsceereeees 20 Cleaning and Inspection Procedures 21 Inspection Recommendation s csseeseees 21 Cleaning nenea a a iea 21 Visual Inspection s sssssssssssseseresseseressessesseeses 21 Mechanical Inspection ccccessccesteesteeeeeees 22 Testing Procedures sssseccccsesseescsssenes 23 Functional Testing ssssessseseeeresseseressesseseees 23 Air Detector Test if Applicable 26 Occlusion Tests cssssesieisesesstessssonreessestvosees 26 ACCULACYVeSting sctscessevsstarsseetiistessesestestevers 28 Cleaning and Functional Testing Checklist 31 1 Introduction The Technical Manual is intended to provide a basic but limited understanding of the mechanical and electrical operation of the Deltec CADD Prizm Computerized Ambulatory Drug Delivery pump to persons familiar with this device The CADD Prizm Operator s Manual 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 Prizm pump This technical manual is applicable to both the CADD Prizm PCS and CADD Prizm VIP pumps For information on the CADD Prizm PCS pump refer to the information regarding the CADD Prizm VIP PCA application in this manual Testing procedures in the back of this manual are intended to be performed with the pump in the PCA delivery mode IM
30. er which is supplied from the micropower voltage regula tor This regulator will supply 5 volt power until its input voltage is approximately 5 3 volts After that point the output of the regulator will follow the input voltage down 14 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 microprocessor can validate the accuracy of the 5 volt power supply Variations in the 5 volt supply left undetected can result in inaccuracy in the low battery alarm set points and variations in other calculated values Voltage CADD Pump Status Trip Point gt 7 0V No alarm 6 4 7 0V Transition to low battery condition battery low message appears 3 beeps every 5 min Transition to depleted battery condition battery depleted message appears continuous alarmtt Hardware reset occurs Pump continues to indicate depleted battery condition 5 25 5 95V Voltage ranges are due to component tolerances Actual trip values are guaran teed to be non overlapping Table 12 CADD Prizm pump low battery conditions t The pump emits 3 beeps every 5 minutes and the message 9 Volt Battery Low 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 mes
31. ery and enable audible and visual alarms if the set is unlatched during fluid delivery Opposing infrared transmitters and receivers on both the latch and lock buttons allow the microprocessor to detect their open and closed positions Additional circuitry allows these sensors to be turned on and off by the microprocessor to conserve battery power Additionally control of sensor power allows the microprocessor to test the sensor inputs in both the powered and unpowered states thus allowing detection of sensor fault conditions Voltage Detector Circuit Low voltage detection is performed by part of the watchdog circuit and by the microprocessor via software Three low voltage levels are detected The first two levels 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 6 8 volts An Analog to Digital Converter ADC built into the microprocessor allows the micropro cessor via software to monitor the battery voltage At the Low Battery Warning thresh old the microprocessor enables a periodic series of beeps and displays a low battery warning message on the LCD As the battery voltage reaches a nominal value of 6 3 volts the software disables delivery places a battery depleted message on the LCD and enables a constant two tone audible alarm When the battery voltage decays to a nominal value of 5 6 volt
32. eservoir 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 28 Procedure 1 Fill the 50 or 60 ml syringe with 40 ml of water Transfer the water into a Medication Cassette reservoir Remove any air from the Medication Cassette 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 extension set luer lock connector Secure the clamp as close to the extension set luer lock connector as possible This should assure a minimum water loss from the tubing when the syringe is removed Weigh the entire reservoir extension set assem bly and record the weight This is the pre delivery weight This weight includes the empty Medication Cassette reservoir exten sion set and weight of the water Attach the Medication Cassette reservoir to the pump Program the reservoir volume to 20 ml Now press the ENTER key This value is the intended delivery volume One ml of water at 20 C weighs 1 gram Open the clamp With the pump in Lock Level 0 program a continuous rate of 0 ml hr and a dose of 1 0 ml but do not deliver a Demand Dose Start the pump and deliver a clinician bolus of 20 ml Again secure the clamp as close as possible to the end of the extension set luer lock connec tor Remove the Medicat
33. for intravenous intra arterial subcutaneous intraperitoneal epidu ral space or subarachnoid space infusion Epidural administration is limited to short term infusion of anesthetics and either long or short term infusion of analgesics Subarach noid administration is limited to short term infusion of analgesics The pump s flexibility Indicator Lights Amber Green Display Data In Out Jack Air Detector Port Cover Mi Air Detector optional Upsteam Occlusion Sensor Model 6101 only Front View Figure 1 Front and back views of the CADD Prizm pump allows it to be used in a variety of settings The CADD Prizm VIP Variable Infusion Profile pump may be programmed to deliver medication in one of four delivery modes 1 PCA patient controlled analgesia 2 Continuous 3 Intermit tent and 4 TPN total parenteral nutrition See Figures 2 through 5 The CADD Prizm PCS Pain Control System pump may be programmed to provide patient controlled analgesia therapy Figure 1 shows a diagram of the CADD Prizm pump Polemount Bracket Recess Battery Compartment Cassette Lock Cassette Latch Cassette Rear View Clinician Bolus used here as a loading dose Demand Doses Continuous Rate Figure 2 PCA mode delivery profile Delivery Rate ML HR Continuous Delivery Figure 3 Continuous mode delivery profile oer YCLE DELAY pant Eaa
34. h the data If the stored and calculated CRCs do not match the software will 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 turn on a continuous two tone audible alarm and stop all drug delivery Timer Data Registers The data stored in the timer control register is checked at regular intervals If the data is not correct the software will turn on a continuous two tone audible alarm and stop all drug delivery 19 Hardware and Software Fault Detection Overview Order of Error Code Events If the CADD Prizm pump displays an error 1 There is a continuous two tone audible code a hardware or software fault has been alarm a continuous amber indicator light detected by the microprocessor and the pump and the display will read should be returned for servicing When hardware or software faults are detected by the microprocessor pump operation stops Error Detected and a continuous audible alarm will be acti E XXXXX vated as well as the amber warning LED An error message will be displayed On the next power up the error code will again be dis played with the software level see illustration NOTE below If the error detected was a data fault dio the pump wi
35. hus the maximum pressure which can be developed is 186 kPa 1 86 bar 27 psi To deliver the amount of drug specified by the parameter settings the pump s microprocessor Pump Housing Expulsor B Occlusion Sensor Cassette BA Pump _ causes the pump mechanism to deliver 0 05 ml or 0 1 ml with a CADD Prizm high volume administration set fluid pulses timed according to the desired rate At rates higher than 3 ml hr 2 pulses in succession will be given Thus to deliver 20 ml hr for example the microprocessor 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 Volume Resolution ml Cassette or 0 0 050 Admin Set 1 0 100 0 100 0 200 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 Camshaft Ta Lock Button Latch Button Ss Mes Plate Inlet Valve Outlet Valve Figure 7 A simulated pumping mechanism in a CADD Prizm pump 15 Air Detector The air detector is designed to detect air in the outlet tubing fluid path The air detector is detachable if not needed The CADD Prizm pump automatically detects the presence of the
36. ife of 5 years System Operating Temperature 2 C to 40 C 36 F to 104 F System Storage Temperature 20 C to 60 C 4 F to 140 F Power Pack Charging Temperature 10 C to 35 C 50 F to 95 F System Delivery Accuracy 6 nominal High Pressure Alarm 18 9 psi Air Detector Alarm Single bubble greater than 0 100 ml PCA 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 Units Milliliters ml milligrams mg micrograms 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 Mcg ml 1 2 3 4 5 10 15 95 100 200 300 400 500 Default 1 mg ml Continuous Rate 0 to 30 ml hr or the mg or mcg equivalent See Table 1 for scroll ranges Default 0 mg hr Demand Dose 0 to 9 9 ml or the mg or mcg equivalent See Tables 2 3 and 4 for scroll ranges Default 0 mg hr Delivery rate Continuous Rate Demand Dose 125 ml hr nominal Demand Dose Lockout 5 minutes to 24 hours in the following increments 1 minute for values between 5 and 20 minutes 5 minutes between 20 minutes and 24 hours Default 5 minutes Max Doses Per Hour 1 to 12 doses in 1 dose increments will also be limited by the Demand Dose Lockout value Default 1 Demand Doses Given 0 to 999 Demand Dose Attempts 0 to 999 System is defined as a CADD Prizm pump
37. in resonance with the output of the oscillator The piezo disk is mounted to the pump housing to enhance sound level The oscillator which drives the piezo disk is capable of providing two driving frequencies The low frequency is in the range of 700 to 1500 Hz and the high frequency is in the range of 1600 to 2500 Hz The micropro cessor controls the audible alarm via control lines from the Gate Array When the micropro cessor selects both the low and high frequency control lines the audible 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 watch dog timer circuitry also have the ability to enable the audible alarm via the Gate Array Watchdog Timer Circuit Watchdog timer circuitry is provided to moni tor 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 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 microprocessor can force a watchdog time out After being reset the microprocessor chec
38. ion Cassette reservoir from the pump and weigh the entire reservoir extension set assembly This is the postdelivery weight Calculate the difference in weight between the predelivery weight and the postdelivery weight This is the weight of the amount delivered Find the difference between the volume of the amount delivered and the intended delivery volume This is the inaccuracy volume 10 Divide the inaccuracy volume by the intended delivery volume and multiply by 100 This is the accuracy error percentage See Table 14 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 19 5 ml 20 ml 0 5 ml 0 5 ml 20 0 ml 0 025 x 100 2 5 0 025 Table 14 Gravimetric percentage calculation 11 If the accuracy error percentage is greater than 6 repeat the test with a new reservoir If the pump fails a second time call Deltec s Customer Service Department EXAMPLE Predelivery Weight 61 1 Postdelivery 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 ml Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 Volumetric Accuracy Testing Option
39. ith the solid dot The display should show Cassette Locked Unlock the cassette The display should show Cassette Unlocked Unlatch the cassette The display should show Cassette Unlatched Close Clamp To Prevent Free Flow NOTE The basic electrical and mechanical functions of the CADD Prizm pump are the same for each of the four delivery modes Regardless of the delivery mode the delivery accuracy and timing circuitry remains unchanged Although functional testing of the CADD Prizm pump can be performed in any mode the remaining tests are intended to be performed in the PCA delivery mode Additional tests may be performed with the pump in a different delivery mode if desired The following three checks LCD motor and gear train and Reservoir Volume is Zero alarm should be performed in the sequence shown LCD Check e Remove and reinsert the battery After a few seconds the LCD will display all off pixels dots followed by all on pixels Examine the LCD for missing dark or light pixels 24 e Program the pump to the following parameters Reservoir Volume 2 0 ml Units Milligrams Concentration 1 0 mg ml Continuous Rate 30 0 mg hr Demand Dose 0 0 mg 0 0 mg press the ENTER key to clear Press the NEXT key until reservoir volume is displayed on the LCD Press the Y or N key until 2 0 ml is displayed Then press the ENTER key Select Milligrams for units and press the ENTER key Sel
40. ks the status flag to see if this was a time out test If so the microprocessor continues normal power up activities If the reset occurred when the microprocessor was not expecting it the microprocessor traps the event sounds the audible alarm and displays an error message on the LCD Motor Driver 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 to and from the microprocessor circuit allow the microproces sor to 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 watch dog timer expires Rotation of the motor is sensed by the micro processor via an infrared sensitive photo 13 detector An infrared light source is mounted 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
41. ll be in Lock Level 2 and all other A AA programmed functions will have default 2 To silence the error code alarm remove the values See the pump s Operator s Manual for battery specific defaults 3 At the next power up the last error code lec will be visible on the display The er cpus Pumpmodelnumber microprocessor will also record an error CADD PRIZH ELY code in the Event Log The description lec WHARY Error Detected along with five digits will Sh AMAA ee 8254 8 appear in the LCD in the Event Log These 625 AAARK BAAB A five digits will remain in memory and will appear on the Event Log record until 500 Terminal Serial number Software revision level data writes have occurred or until the mode has been changed See Testing Procedures starting on page 23 of this manual for detailed instructions regarding the power up check Thus there is always a record of the last internal fault detected by the micropro cessor 20 Cleaning and Inspection Procedures Inspection Recommendation Deltec recommends annual functional inspec tion on the CADD Prizm pump The follow ing inspection and testing 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 Prizm pump Please read the Operator s Manual supplied with the pump before proceeding WARNING
42. manner as the DOSE key When the Re mote Dose Cord is attached to the pump the patient may press either the Remote Dose button or the DOSE key to receive a Demand Dose The clinician may also use either the Remote Dose button or the DOSE key to deliver a clinician bolus For easy access the Remote Dose cord may be fastened to the patient s clothing or bedsheet with the attached clip NOTE To detach the Remote Dose cord from the pump grasp the Remote Dose cord connector and pull back using a straight steady motion Do not twist or turn the connector or use any instrument to remove it For additional specifications refer to the Operator s Manual provided with the product Batteries Battery Compatibility Recommended Batteries Nine volt alkaline or lithium batteries are recommended for use in the CADD Prizm pump Carbon zinc mercury nickel cadmium or zinc air 9 volt batteries should not be used Battery Life The CADD Prizm pump has been designed to provide optimal battery life The expected battery life in the CADD Prizm pump depends on the following factors e Programmed delivery rate e Operating temperatures e Frequency of display backlighting e Frequency of printing e Battery type and brand e Battery age DURACELL Alkaline Battery Life The following tables may be used to predict typical alkaline battery life at different delivery rates when an alkaline battery is used in the
43. ment needed e CADD administration set with anti siphon valve e Tubing clamp slide clamp or hemostat 27 Procedure 1 Spike an appropriate standard I V bag 2 Prime the entire fluid path 3 Program the pump to deliver a continuous rate of 20 ml hr 4 Start the pump 5 Clamp the tubing halfway between the fluid reservoir and the pump 6 The pump should alarm within three activa tions after clamping the tubing Note Make sure the upstream occlusion sensor is turned on in the Biomed Toolbox Accuracy Testing Accuracy testing may be performed in any delivery mode This manual shows an example of delivery accuracy testing with the pump in the PCA delivery mode Gravimetric Accuracy Testing Option 1 Description A Medication Cassette reservoir is partially filled with water and weighed The reservoir is then attached to the pump and the pump is set to deliver a certain amount of water The reser voir 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 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 r
44. nfrared light source infrared detector occlusion sensor cassette sensors lock and latch Via the motor driver circuitry the pump s microprocessor controls motor rotation Two external port connectors are utilized for communication and external power input One of these connectors the data in out jack is used for attachment of the Remote Dose cord This 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 DOSE key This jack can also be connected to an external printer via the interface cable With this feature the patient or clinician can print various pump reports The second port is for external power connection This port the power jack can receive input from either an AC adapter or the External Power Source rechargeable power pack Connections between the printed circuit boards are designed for ease of manufacturing and serviceability The keyboard is connected to the microprocessor board via a flex circuit tail Flexible circuitry and discrete wires connect the pumping mechanism motor and sensors to the printed circuit boards 11 Theory of Operation Keyboard Circuitry The CADD Prizm pump is controlled by a microprocessor The actions of the micropro cessor are controlled by a program which is contained in the memory Commands are issued to the microprocessor from the user via the nine keys on the key boar
45. o sersa aes 11 Theory of Operation sccssssccccsssseees 12 Keyboard Circuitry ccccccssscceesceessecceeneeeees 12 Data Memory EEPROM ccssssececceceeeeees 12 Battery Backed RAM ecescceessecesseceeeneeeees 12 Time Base Circuitry oannes 12 ECD Cir Cunt ry iss heise tues itinira t tates 12 LED Status Indicators cescesscceseeesteeeneeees 13 Flash PROM Technology ccscceseeesteeee 13 Gate Array Circuitry cccsscssccccccceceeeseeeeeees 13 Audible Alarm Circuitry ccccccccssscceeseeees 13 Watchdog Timer Circuit cccscceseesreeeeees 13 Motor Driver Motor Watchdog Circuit 13 Power Gircultry ai cients nannies 14 Voltage Reference Circuit cccccceeseseseeees 14 Pumping Mechanism cssccesseeereeereeeeeeees 14 Pumping Characteristics cccssccsseeeseeeeees 15 Alt Detector anara a a 16 Upstream Occlusion Sensor ssssssesseeesseeessee 16 Safety Features and Fault Detection 17 Hardware Safety Features c ccccsscceeeseeees 17 Watchdog Timer Circuit ccccccecsscceereeees 17 Motor Driver Motor Watchdog Circuit 18 Cassette Type Sensor Circuit eseeeeeeeeeeee 18 Latch Lock Sensor Circuit cc cecssceeseeeteees 18 Voltage Detector Circuit ccccccesesceeeseeees 18 Software Safety Features ccccccccsscceseseceees 19 Hardware and Software Fault Detection 20 OVERVIOW oserei rata teil pa aE EEEE E R 20 Ord
46. r checks the status flag to see if this was a time out test If so the microprocessor continues normal power up activities If the reset occurred when the microprocessor was not expecting it the microprocessor traps the event sounds the audible alarm and displays an error message on the LCD AUDIBLE ALARM VOLTAGE REFERENCE MOTOR WATCHDOG VOLTAGE DETECTOR WATCHDOG REAL TIME CLOCK gt SENSORS 17 Motor Driver 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 to and from the microprocessor circuit allow the microprocessor to 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 watch dog timer expires Cassette Type Sensor Circuit The cassette Type sensor system consists of three pins protruding from the button of the pump mechanism that interface to the attached administration set and associated circuitry Ea
47. rn counter clockwise The reservoir or the administration set is locked into place by inserting a key into the pump s lock and turning the lock one quarter turn counterclockwise NOTE The cassette lock must be unlocked before attempting to unlatch the disposable 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 nine membrane switches 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 custom Liquid Crystal Display LCD also located on the front housing shows the pump status and programmed settings The dot matrix display consists of 21 character col umns with 4 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 two printed circuit boards The microprocessor board contains the Central Processing Unit CPU and its associated circuitry motor driver circuitry and other miscellaneous circuitry The LCD board contains the Liquid Crystal Display with its associated circuitry and the backlight module with its associated circuitry The pumping mechanism subassembly contains the motor gear train camshaft valves expulsor sensing disk i
48. s a hardware reset circuit is triggered which places the microprocessor in reset This prevents ambiguous microprocessor operation when the battery voltage continues to decay The hardware reset continues until the battery is completely discharged or until it is removed Once the pump controller goes into low battery shutdown only replacing the old battery with a fresh one will clear the condition 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 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 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
49. s 1610 ml 30 ml hr 79 hrs 2370 ml 50 ml hr 60 hrs 3000 ml 100 ml hr 30 hrs 3000 ml 200 ml hr 32 hrs 6400 ml 350 ml hr 17 hrs 5950 ml Table 5 9 volt Lithium type batteries used with the CADD Prizm pump Rate Volume 100 ml hr 6400 ml 200 ml hr 13400 ml 350 ml hr 13650 ml Table 6 EPS System used with the CADD Prizm pump Intermittent Delivery Battery Life Note Results are without air detector Duration Cycle KVO Life Volume 0 2 ml hr 0 2 ml hr 1 00 hr 5 00 hr 1 00 hr 6 00 hr 1 00 hr 6 00 hr 0 2 ml hr 1 00 hr 12 00 hr 0 2 ml hr 117 hrs 477 ml 71 hrs 733 ml 38 hrs 798 ml 84 hrs 1415 ml Table 7 9 volt Alkaline type batteries used with the CADD Prizm pump Volume Duration Cycle KVO Life Volume 0 2 ml hr 0 2 ml hr 23 5 1 00 hr 5 00 hr 61 1 00 hr 6 00 hr 125 1 00 hr 6 00 hr 0 2 ml hr 200 1 00 hr 12 00 hr 0 2 ml hr Table 8 9 volt Lithium type batteries used with the CADD Prizm pump 301 hrs 1229 ml 183hrs 1891 ml 120 hrs 2520 ml 186 hrs 3134 ml TPN Delivery Battery Life Note Results are without air detector Volume Period Taper Up Taper Down KVO Volume 2000 10 00 hr 1 00 hr 1 00 hr 5 ml hr 3000 10 00 hr 1 00 hr 1 00 hr 5 ml hr 2333 ml 2497 ml Table 9 9 volt Alkaline type batteries used with the CADD Prizm pump Volume Period Taper Up Taper Down KVO Volume 2000 10 00 hr 1 00 hr 1 00 hr 5 ml hr 3000 10 00 hr 1 00 hr 1
50. sage 9 Volt Battery Depleted appears on the display the battery power is too low to operate the pump and pump operation has stopped Pumping Mechanism The pumping mechanism is linear peristaltic with two active valves Pumping 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 7 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 or 0 100 ml of fluid with a CADD Prizm high volume administration set 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 If the fluid path to the patient becomes blocked the pump tubing will expand as pumping occurs When there has been an amount of inflation corresponding to 124 62 kPa 1 24 0 62 bar 18 9 psi the occlusion analog sensor trips whereupon the micropro cessor stops the pump mechanism and issues visual and audible alarms T
51. sing with two screws and electrically connected with a ten pin connector 16 Theory of Operation The air detector consists of sensor electronics and two ultrasonic transducers positioned on opposite sides of the tubing 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 Upstream Occlusion Sensor Theory of Operation The upstream occlusion sensor is a strain gauge device capable of detecting pressure changes in the disposable tubing set This is accomplished by using a loading ball or sphere located on the bottom of the pump This loading ball contacts the pump tubing when a tubing set is attached to the pump Under normal operation the pump tube pushes outward and applies a specified force on the sensor When an upstream occlusion is present the upstream tubing collapses pulling away from the sensor reducing the force on the sensor It is this change of the force that indi
52. sory 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 Visual Inspection e Visually inspect the pump for any damage to the LCD occlusion sensor seals valves and expulsor reservoir hinge area latch lock cassette sensors 3 keyboard indicator lights power jack data in out jack air detector port cover or air detector and housing If any damage is noted the pump should be returned for service e Check the battery door for proper operation It should not be broken or damaged The mating tabs on the pump housing should not be broken or damaged e Examine the battery compartment for dam age If the battery contacts appear corroded clean them with a cotton swab and isopropyl alcohol If the battery contacts appear to be bent or pushed in straightening may be possible with a small screwdriver or other suitable tool Care must be taken so as not to damage the pump housing or to incur further damage to the contacts 21 Mechanical Inspection Press each key on the keyboard Each key should have a distinctive dome feeling The keys should not feel flat Attach the battery door The battery door should fit snugly in place when it is closed on the pump Attach either a 50 or 100 ml Medication Cassette reservoir or a CADD administra tion set to the pump Check for smooth operation and
53. ss the ENTER key NOTE The remaining testing procedures should be performed using a 50 or 100 ml Medication Cassette reservoir containing fluid and a primed extension set with anti siphon valve or a primed CADD administration set with anti siphon valve Starting Stopping the Pump Check the STOP START key by pressing it Start the Pump should be displayed Press the Y key The display should show Starting Pump followed by a review of the pro grammed parameters The main screen should appear with RUNNING in the display and the green LED indicator light should blink every 3 seconds To stop the device press the STOP START key When the message Stop the Pump appears press Y STOPPED appears in the display and the amber LED indicator light blinks Activation Timing Check Check the activation timing by programming the pump with the following values Reservoir Volume 1 0 ml Units Milligrams Concentration 1 0 mg ml Continuous Rate 30 0 mg hr Demand Dose 0 0 mg Milligrams Given 0 0 mg press the ENTER key to clear Press the STOP START key Press the Y key Starting Pump should appear on the display The pump should sequentially dis play all of the programmed values Start a timer at the first motor activation Count the activations One activation should occur every twelve seconds Approximately one minute fifty seconds 1 50 and ten activations later the RES VOL
54. ssette reservoir design are Deltec Inc trademarks DURACELL is a DURACELL Inc trademark ULTRALIFE is a ULTRALIFE Batteries Inc trademark LEMO is a LEMO USA INC trademark SaniCloth is a PDI trademark 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 5 181 910 5 338 157 5 364 242 5 485 408 5 531 697 5 531 698 5 538 399 5 540 561 5 564 915 5 567 136 5 567 119 5 695 473 Model 6101 only other patent s pending 2002 Deltec Inc All rights reserved Printed in U S A 4 02 19824 C ISO 9001 Registered smiths Smiths Medical a part of Smiths Group plc
55. ted the microprocessor will enable the high brightness backlight since this does not consume power from the battery The backlight automatically shuts off when the LCD is turned off LED Status Indicators An amber and a green Light Emitting Diode LED are provided under the pump s front panel overlay to provide pump status to the user Under software control the LEDs can either flash at a low duty cycle or be on con tinuously A flashing indicator typically indi cates a normal mode of operation and a steady on indicator typically indicates a fault condition 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 through the I O port on the side of the pump Several layers of redun dancy in the programming system prevent accidental erasing or modification of the PROM Gate Array Circuitry The Gate Array contains circuitry which controls memory address decoding keyboard debounce Light Emitting Diode LED indica tor status LCD command buffering Battery Backed RAM interface and miscellaneous signal line buffering functions Audible Alarm Circuitry Audible alarm circuitry consists of a piezo electric disk and independent oscillator The disk flexes or bends
56. tely shown the pump has powered up normally The pump should sequentially display all of the programmed values The words Self Test Complete should appear then the text Power Up Successful with six audible beeps Continue with the Latch Lock check Latch Lock Check e Attach a 50 or 100 ml Medication Cassette reservoir or a CADD administration set to the pump The mark on the latch should be aligned with the solid dot The display should show that the reservoir or administration set is latched See Table 13 Reservoir Latched The Medication Cassette reservoir has been latched onto the pump Admin set Latched The CADD adminis tration set has been latched onto the pump High Volume The CADD Prizm Admin Set Latched high volume adminis excluding PCA tration set has been genes mode latched onto the pump Table 13 e Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot The display should show Cassette Locked e Unlock the device by inserting a key into the lock and turning clockwise until the mark lines up with the open dot The display should show Cassette Unlocked e Unlatch the reservoir by inserting a coin into the latch slot and turning clockwise until the mark lines up with the open dot The display should show Cassette Unlatched Close Clamp to Prevent Free Flow Cassette Sensor Check e Atta
57. tes when a lithium battery is used in the CADD Prizm pump As expected battery life decreases as the delivery rate increases These tables are based on laboratory tests using fresh ULTRALIFE lithium batteries in CADD Prizm 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 Lithium battery life is dependent upon the temperature and relative humidity of storage Recommended storage conditions are less than 20 C 68 F with a desiccant to ensure less than 10 relative humidity The following tables are based on laboratory tests conducted at room temperature using fresh ULTRALIFE lithium batteries and a CADD administration set Actual battery life depends upon the brand of battery selected the particular battery selected battery shelf life and temperature conditions Deltec s testing indicates a large variability in battery life Continuous and PCA Delivery Battery Life Max Delivery Rate PCA Mode 30 ml hr Note Results are without air detector Rate Life Volume 0 4 ml hr 120 hrs 48 ml 10 ml hr 86 hrs 860 ml 30 ml hr 37 hrs 1110 ml 50 mi hr 26 hrs 1300 ml 100 ml hr 13 hrs 1300 ml 200 ml hr 14 hrs 2800 ml 350 ml hr 7 hrs 2450 ml Table 4 9 volt Alkaline type batteries used with the CADD Prizm pump Rate Life Volume 0 4 ml hr 212 hrs 85 ml 10 ml hr 161 hr
58. ttery for rates up to 250 ml hr use power pack or AC adapter for rates up to 350 ml hr KVO Rate Calculated by pump 1 10 of Plateau Rate up to 5 ml hr Given 0 to 99999 in 0 1 unit increments 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 ml in the following increments 0 1 for values between 0 0 and 100 1 for values between 100 and 1000 Default 0 0 ml Dose Duration 1 min to 24 hrs in the following increments 1 minute for values between 1 min and 10 min 5 minutes for values above 10 min Default 30 min Duration is limited by Dose Volume so that rate does not exceed 350 ml hr Use 9 volt battery for rates up to 250 ml hr use power pack or AC adapter for rates up to 350 ml hr Dose Cycle 10 min to 96 hrs in 5 minute increments Default 4 hrs KVO Rate 0 to 10 ml hr in 0 1 ml hr increments Default 0 ml hr Next Dose Start Time 10 min to 96 hrs X min where X equals a 10 minute increment in the 96th hour or Imme diate programmable in 10 minute increments Default Immediate Given 0 to 99999 9 in 0 1 unit increments Time Remaining Dose and Cycle display in 1 minute increments Options Specifications Immediate Taper Down TPN 0 to time remaining in the infusion period in 10 minute increments defaults to the currently programmed Taper Down AutoLock Not In Use
59. with an attached Medication Cassette reservoir and CADD extension set with integral anti siphon valve or an attached CADD administration set with integral or add on anti siphon valve Given 0 to 99999 99 in 0 01 unit increments Clinician Bolus 0 1 ml to 20 00 ml or mg or mcg equiva lent See Tables 2 3 and 4 for scroll ranges Delivery rate Continuous Rate Clinician Bolus 125 ml hr nominal 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 to 350 ml hr in the following increments 0 1 for values between 0 1 and 100 1 for values between 100 and 350 Default 0 ml hr Use 9 volt battery for rates up to 250 ml hr use power pack or AC adapter for rates up to 350 ml hr Given 0 to 99999 9 in 0 1 unit increments TPN Delivery Mode Specifications Reservoir Volume 10 0 to 9990 or Not In Use program mable in 1 ml increments displayed in 0 1 ml increments Default 10 ml Infusion Volume 10 to 9990 ml in 10 ml increments Default 10 ml Infusion Period 0 hrs 10 min to 99 hrs 50 min in 10 minute increments Default 1 hr 0 min Taper Up Period 0 hrs 0 min to 99 hrs 40 min in 10 minute increments Default 0 hrs 0 min Taper Down Period 0 hrs 0 min to 99 hrs 40 min in 10 minute increments Default 0 hrs 0 min Plateau Rate Calculated by pump 10 to 350 ml hr Use 9 volt ba

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