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Sims Deltec CADD

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1. The procedure for changing a programmed setting is similar for most programming screens e Make sure the pump is stopped and in Lock Level 0 e To begin programming start at the main screen and press e To change a setting press or Y until the desired setting appears Press and hold these keys to change values with increasing speed e Press within 25 seconds to confirm a change or the screen will revert to the previous setting D a SE OE a8 ES i a A e If any key other than is pressed Value not saved will appear Press to return to the screen being pro grammed scroll to the desired value and press 8 e Press wer to advance to the next screen e To leave a setting unchanged press Qer to go to the next screen 18 Section 2 Pump Setup and Programming Delivery Methods The CADD Legacy PLUS pump has two delivery methods and provides delivery in milliliters per hour e Continuous Delivery Mode up to 125 ml per hour e Intermittent Delivery Mode up to 125 ml per hour The Continuous Delivery Mode CDM permits a steady infusion rate In this mode you can program the pump to deliver medication at a constant rate in milliliters per hour y JU SES Gs z me 30 3 Delivery ZS Rate ml hr amp g Time The Intermittent Delivery Mode IDM delivers a specified dose volume over a specified duration You may repeat the dose in a cycle of up to 96 hours The K
2. Then when necessary you can adjust the Continuous Rate up to the maximum value that was programmed in LLO Programming the pump to use this feature 1 During initial programming in LLO enter the upper limit value for the Continuous Rate This will be the maximum value when the pump is in LL1 av 2 D 3 3 5 Co 33 dn s dund 2 After you are finished programming change the lock level to LL1 3 Decrease the Continuous Rate to its starting value then press GH Adjusting the rate while the pump is in use If it becomes necessary to increase the Continuous Rate during the course of therapy stop the pump but remain in LL1 1 Press wer until the Continuous Rate screen appears 2 Press a or Y to select the desired value then press B88 3 Restart the pump if appropriate 39 Section 2 Pump Setup and Programming IDM Stopping the Pump During the Dose Stopping the pump while a dose is in progress will shift all subse quent doses by the amount of time the pump is stopped Pump is All stopped subsequent for 10 doses shift by minutes 10 minutes oD ae OE mae ES ae If you wish to make up for the lost time in the cycle it is recom mended that you wait until the current dose is completed If the pump is stopped while a dose is infusing and you reprogram the Dose Starts in screen then the pump will not deliver the remain der of that dose To determine the amo
3. Watchdog Timer Circuit The microprocessor must send an appropriate signal to the watch dog circuit at least once per second If the microprocessor does not the watchdog circuit will time out and shut down the pump control ler 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 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 the memory and not strobing the watchdog the 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 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 transis tors passive components and two voltage comparators Built into the motor drive circuitry is an RC timer which times how long the motor runs each t
4. LLO permits complete access to all programming and operating functions LL1 permits limited control of pump programming and operations LL2 permits only minimal control pump operations Continuous Delivery Mode CDM Intermittent Delivery Mode IDM Pump Operations and Programming Stop Start the pump Stopped Running Yes LL1 Yes Yes Any Lock Level Reset Reservoir Volume Yes Yes Yes Prime Yes Yes No Change the lock level Yes w code Yes w code Yes w code Change Continuous Rate CDM Yes Up to LLO value No Clear Given amount CDM amp IDM Yes Yes No Change Dose Volume IDM Yes No No Change Dose Duration IDM Yes No No Change Dose Cycle IDM Yes No No Change KVO Rate IDM Yes No No Change Dose Starts in delay IDM Yes No Biomed Functions Access to Functions Yes w code No No No Air Detector On Off Yes w code View only View Only View Only Upstream Occlusion Sensor On Off Yes w code View only View Only View Only Changing the Delivery Mode 10 Yes w code View only View Only View Only Section 2 Pump Setup and Programming 2 0 Pump Setup and Programming Installing or Replacing the Batteries Use new AA alkaline batteries such as DURACELL or EVEREADY ENERGIZER batteries
5. 8 OD a 3 OE Aw ES ao 2 Press and hold eme You will hear a single beep and the word Prime will appear on the display 3 After Prime and three sets of dashes appear and you hear three beeps release Grma 4 Press and hold again to fill the fluid path and to eliminate air bubbles The screen displays Priming and you will hear a short beep each time the pump goes through a delivery cycle gt NOTE e The air detector alarm is automatically disabled when priming e Fluid delivered during priming is subtracted from the Reservoir Volume but is not added to the Given screen since this fluid is not delivered to the patient 5 If the tubing is not yet fully primed press and hold again If the tubing is primed press to return to the main screen 34 Section 2 Pump Setup and Programming NOTE Each time you press and hold eme you pump a maximum of 1 0 ml of fluid into the tubing The pumping action will stop automatically when 1 0 ml has been deliv ered If all of the air has not been removed from the fluid path repeat the above priming procedure If the Air Detector is in use go to the next section If not connect the tubing to the patient s infusion set or indwelling catheter and go to Setting the Lock Level for the Patient WARNING Ensure that the entire fluid path is free of all air bubbles before connecting to the patient to prevent air embolism Air emboli
6. 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 or 100 ml Medication Cassette Reser voir or a CADD Administration Set to the pump Using a coin turn the lock 1 4 turn counterclockwise 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 lock should be aligned with the arrow on the side of the pump e Gently twist and pull on the cassette to make sure it is firmly attached Testing Procedures Functional Testing 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 Last Error Code and four digits appear prior to the pump displaying the 32 character 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 sequentially display all of the programmed values and beep at each screen After all screens are displayed success EPET ETER 69 Section 5 Reference ful power up is indicated with six audible beeps and the STO
7. Reinstall batteries or install new batteries Press and hold to restart the pump a2ua1ajoy 49 3 5 c g o CY cc Section 5 Reference Messages and Alarms Description Corrective Action No message TWO TONE ALARM With no AC adapter attached the batteries have been removed while the pump is running The pump is now stopped and unpowered Install batteries to silence the alarm OR Batteries were removed within approxi mately 15 seconds after stopping the pump Install new batteries to silence the alarm if desired Otherwise the alarm will stop within a short period of time Error TWO TONE ALARM An error has occurred Remove the pump from service and contact Customer Service to return the pump for service High Pressure TWO TONE ALARM The pump has detected high pressure which may be resulting from a down stream blockage kink in the fluid path or a closed tubing clamp Remove the obstruction to resume operation Or press e or to stop the pump and silence the alarm for 2 minutes then remove the obstruction and restart the pump Key pressed Please release TWO TONE ALARM If a key is being pressed stop pressing it If the alarm persists close the tubing clamp and remove the pump from use Contact Customer Service to return the pump for service LowBat THREE TWO TONE BEEPS EVERY 5 MINUTES 50 The batteries are low but the pump is still operable
8. The pump retains all pro grammed values while the batteries are removed Dispose of used batteries in an environmentally safe manner and according to any regulations which may apply WARNING e Do not use rechargeable NiCad or nickel metal hydride NiMH batteries Do not use carbon zinc heavy duty batteries They do not provide sufficient power for the pump to operate prop erly which could result in death or serious injury to the patient ay e Ce 9 3 E j 33 dn s dund e Always have new batteries available for replacement If power is lost nondelivery of drug will occur and depending on the type of drug being administered could result in death or serious injury to the patient e If the pump is dropped or hit the battery door or tabs may break Do not use the pump if the battery door or tabs are damaged because the batteries will not be properly secured this may result in loss of power nondelivery of drug and depending on the type of drug being administered death or serious injury to the patient 11 Section 2 Pump Setup and Programming In order to install or replace the batteries be sure the pump is Stopped Then follow these steps 1 Push down and hold the arrow button while sliding the door off 2 Remove the used batteries Pulling on the end of the battery strap will make battery removal easier oD OE a8 ES D gt a A 3 Install the ne
9. 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 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 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 Real Time Clock is checked at regular intervals If the data is not reasonable the software will turn on a continuous 67 a2uaJajoy v v g 2 T oc Section 5 Reference two tone audible alarm and stop all drug delivery Annual Functional Inspection and Testing Procedures Deltec recommends annual functional inspections and tests on all CADD Legacy pumps The following inspection and testing procedures should be performed annually to verify function and a
10. delivered is compared to the amount that the pump is programmed to deliver 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 Medication Cassette Reser voir 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 50 or 100 ml Medication Cassette Reservoir 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 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 80 Section 5 Reference 3 Attach the end of the extension set to the fluid collection device 4 Attach the cassette 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 125 ml hr Start the pump and wait for the reservoir volume empty alarm 6 When delivery is complete record the volume of fluid deliv
11. has an expected life of 5 years 2 C to 40 C 35 F to 104 F System Storage Temperature oe System Delivery ACCULACY sennae System Definition High Pressure Alarm Air Detector Alarm Maximum Volume Infused under Single Fault Condition Delivery Rate during PRM S gaserna Alarm Disabled during PEIMING Core seoectassecceretenevee Section 5 Reference 20 C to 60 C 4 F to 140 F 6 nominal At low infusion rates this accuracy may not be achieved for short periods During the total infusion time the accuracy averages out see accuracy curves pages 62 and 63 System is defined as a CADD Legacy pump with an attached Medication Cassette Reservoir and CADD Exten sion Set with integral anti siphon valve or an attached CADD Administration Set with integral or add on anti siphon valve 26 14 psi 1 79 0 97 bar Single bubble Low sensitivity greater than 0 250 ml High Sensitivity greater than 0 100 ml Multi bubble 1 0 ml nominal CADD Administration Set with anti siphon valve 0 2 ml Approx 180 ml hr Air Detector EPES ETER 59 eD Uv c g o v x Section 5 Reference Continuous Delivery Mode Specifications Reservoir Volume Continuous Rate 0 1 to 9999 or Not In Use programmable in 1 ml increments displayed in 0 1 ml increments Default 1 0 ml 0 1 to 125
12. intended to be used in conjunction with a particular Licensed Computer Program supplied by Manufacturer and use of any other program or unauthorized modifi cation of a Licensed Computer Program shall void Manufacturer s warranty as set forth above 2 The Original Purchaser and any users authorized by the Original Purchaser are hereby granted a nonexclusive nontransferable license to use the Licensed Computer Program only in conjunction with the single Pump supplied by Manufacturer The Licensed Com puter Program is supplied only in machine readable object code form and is based upon Manufacturer s proprietary confidential information No rights are granted under this li cense or otherwise to decompile produce humanly readable copies of reverse engineer modify or create any derivative works based upon the Licensed Computer Program 3 All other terms and conditions of this Limited Warranty shall apply to the Licensed Computer Program The Manufacturer disclaims responsibility for the suitability of the Pump for any particular medical treatment or for any medical complications resulting from the use of the Pump 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 Pump This warranty gives the Original Purchaser specific legal rights and the Original Purchaser may have other legal rights which may vary from stat
13. ml hr programmable in 0 1 ml hr increments Default 0 0 ml 0 to 99999 95 in 0 05 ml increments Intermittent Delivery Mode Specifications Reservoir Volume 60 Dose Volume Dose Duration Dose Cycle KVO Rate Dose Starts in 1 to 9999 or Not In Use programmable in 1 ml increments displayed in 0 1 ml increments Default 1 0 ml 0 1 to 1000 ml programmable in 0 1 ml increments Default 0 0 ml 1 min to 24 hrs in the following incre ments 1 minute for values between 1 min and 10 min 5 minutes for values above 10 min Duration is limited by Dose Volume so that rate does not exceed 125 ml hr Default 30 min 10 min to 96 hrs in 5 minute increments Default 4 hrs 0 to 125 ml hr in 0 1 ml hr increments Default 0 ml hr Immediate or 1 min to 96 hrs in the following increments 1 minute for values between 0 min and 10 min 5 minutes for values between 10 min and 96 hrs Default Immediate Section 5 Reference GIVEN ooeeeeccsccscescssesensceseneens 0 to 99999 95 in 0 05 ml increments Dose Remaining 1 minute increments Biomed Functions Air Detector wince Off On Low On High Default On High Upstream Sensor Off On Default On Delivery Mode cceeee Continuous Intermittent Default Intermittent J p h e fe A p 61 Section 5 Reference Accuracy Test Results The following graphs are designed to show flow accuracy o
14. warnings precau tions or contraindications in the drug labeling Analgesics Administration of analgesics to the epidural space is limited to use with indwelling catheters specifically indicated for either short or long term drug delivery Administration of analgesics to the subarachnoid space is limited to use with indwelling catheters specifically indicated for short term drug delivery Section 1 General Description Anesthetics Administration of anesthetics to the epidural space is limited to use with indwelling catheters specifically indicated for short term drug delivery WARNING e Do not administer drugs to the epidural space or subarachnoid space unless the drug is indicated for administration to those spaces Drugs not intended for epidural or subarachnoid space infusion could result in death or serious injury to the patient 5 i o z oo US m e To prevent the infusion of drugs that are not indicated for epidural space or subarachnoid space infusion do not use ad ministration sets that incorporate injection sites The inadvertent use of injection sites for infusion of such drugs could result in death or serious injury to the patient e Ifa Medication Cassette Reservoir CADD Extension Set or CADD Administration Set is used for drug delivery into the epidural or subarachnoid space clearly differentiate them from those used for other routes of infusion for example by color coding or other
15. whether the Upstream Occlusion Sensor is turned on or off 8 D eS SeE OE Ae ES a a WARNING When the Upstream Occlusion Sensor is turned off the pump will not detect occlusions upstream between pump and fluid container Periodically inspect the fluid container for decreasing volume inspect the fluid path for kinks a closed clamp or other upstream obstructions Upstream occlusions could result in under or non delivery of medications If undetected these occlusions could result in death or serious injury to the patient e If you need to change the Upstream Occlusion Sensor setting see Section 4 Biomed Functions e Press er 12 Review the program Press Qer repeatedly to review the programming screens If you need to reprogram a setting press wer until the appropri ate screen appears and change the setting as described in this section 30 Section 2 Pump Setup and Programming Removing a Cassette WARNING Close the fluid path tubing with the clamp before removing the cassette from the pump to prevent unregulated gravity infusion which could result in death or serious injury to the patient 1 Stop the pump 2 Close the tubing clamp 3 Insert a coin into the lock and turn it clockwise The lock will pop out when you unlock the cassette 4 A continuous alarm will sound and the pump will display No Disposable Clamp Tubing The alarm may be si lenced by pressing
16. 8 Biomed Functions 45 85 Air Detector on off 46 61 Upstream Sensor on off 47 61 82 Biomed Functions Code 9 45 C cassette 4 6 attaching 32 cautions vi removing 31 warnings v cassette lock 4 7 33 cleaning pump accessories 53 54 cautions vi Continuous Delivery Mode 19 Continuous Rate 10 21 39 60 programming 22 cycle 19 D definition system 59 delivery method 19 changing 48 Dose Cycle 26 60 Dose Duration 25 60 Dose Remaining 26 41 61 Dose Starts In 19 26 41 60 Dose Volume 25 60 Downstream occlusion sensor 8 E ECG equipment interference with vi 55 epidural administration warning iv Extension Set Anti Siphon Valve 6 warning iv G Given screen 22 27 29 60 61 clearing 22 28 29 indicator light 4 5 inspection procedures 68 Intermittent Delivery Mode 19 K keypad keys 4 5 KVO rate 19 26 60 L lock cassette 7 33 lock level 5 9 10 Lock Level Code 9 17 38 45 Magnetic Resonance Imaging caution vi 55 main screen 8 43 mounting hole threaded 4 P Polemount Bracket Adapter 7 power jack 3 4 power up 16 priming 27 warning v programming 18 programming screens Continuous delivery mode 20 Intermittent delivery mode 24 R radiation exposure to caution vi 55 reservoir 6 7 20 22 25 28 51 57 attaching 32 cautions vi Section 5 Reference removing 31 warnin
17. OPERATOR S MANUAL CADD Legacy PLUS Ambulatory Infusion Pump Model 6500 CONTINUOUS OR INTERMITTENT DELIVERY This Operator s Manual is for clinician use only Read the entire Operator s Manual before operating the pump SIMS DELTEC INC This manual pertains only to the Deltee CADD Legacy PLUS Model 6500 ambulatory infusion pump This pump can be programmed to deliver medication at a continuous rate or to deliver a specified amount of drug at a set programmed interval This manual is intended for clinician use only Do not permit patients to have access to this manual The pump has three security levels designed to limit patient access Do not disclose the pump s security codes or any other information that would allow inappropriate access to programming and operating functions The issue date of this Operator s Manual is included on the back cover for the clinician s information In the event one year has elapsed between the issue date and product use the clinician should contact SIMS Deltec Inc to see if a later revision of this manual is available Technical Assistance If you have comments or questions concerning the operation of the CADD Legacy pump please call the appropriate number given below When calling please specify your pump s software module This informa tion is located on the start up screen Our staff at Deltec is available to help clinicians twenty four hours a day with the programmin
18. P screen displayed Continue with the lock check Lock Check e Attach a 50 or 100 ml Medication Cassette Reservoir or CADD Administration Set to the pump The line on the lock should be aligned with the arrow on the side of the pump Cassette Sensor Check e Unlock the cassette by inserting a coin into the lock and turning clockwise e The pump will sound a continuous two tone alarm and the display should show No Disposable Clamp Tubing e Press or Cr to silence the alarm Press and hold to turn the pump off The following three checks LCD Motor and Gear Train and Reser voir Volume Empty Alarm Check should be performed in the se quence shown LCD Check e With the pump turned off press ED The second screen that the pump displays will consist of 32 blocks of charac ters Examine the LCD to verify that there are no missing dark in the character blocks D 5 c g o o g Motor and Gear Train Check e Program the Reservoir Volume to 2 0 ml e Attach a 50 or 100 ml Medication Cassette Reservoir or CADD Administration Set to the pump Lock the cassette e Press and hold until three series of dashes appear 70 Section 5 Reference Release tue Press and hold me While priming the tubing 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 Press to return to the ma
19. RUN Restol LowBat 50 8 ml Status of pump Reservoir Volume When stopped Status of pump STOPPED Section 1 General Description Lock Levels Lock levels are used to limit patient access to certain programming and operating functions The table on the next page lists the func tions that are accessible in Lock Level 0 LLO Lock Level 1 LL1 and Lock Level 2 LL2 When a function is accessible the key associated with the function beeps when pressed If a function is not accessible the pump ignores the key press and a beep does not sound Section 2 Pump Setup and Programming describes how to change the lock level g oO u A E e gt Security Codes The following security codes are preset by the manufacturer for the clinician s use e The Lock Level Code 65 the first two digits of the pump s model number allows you to change the pump s lock level e The Biomed Functions Code 165 Lock Level Code 100 allows access to the Biomed Functions See Section 4 WARNING Do not disclose to the patient the pump s security codes or any other information that would allow the patient complete access to all programming and operat ing functions Improper programming could result in death or serious injury to the patient Section 1 General Description Lock Level Table This table lists the operations that are accessible in each lock level while the pump is stopped and running
20. S SeE OE a8 ES i a A 4 Enter the Dose Duration e Press or y to select the desired duration e Press GH 28 Section 2 Pump Setup and Programming e Press we 5 Enter the Dose Cycle e Press or y to select the desired cycle e Press Ge e Press er 6 Enter the KVO rate e Press or iy to select the desired KVO rate e Press GH e Press wer 7 Acknowledge Dose Remaining if applicable e Press wer 8 Enter a delay or Immediate for Dose Starts in ay To D 3 5 Co 79 dnjas dung e Press or y to select the desired amount of delay until the next dose or Immediate e Press Ge e Press Qer 9 Clear Given e Press if you wish to clear the amount given e Press Qer 10 Verify the Air Detector status e Make sure the desired setting is displayed This screen will show whether the Air Detector is turned on high or low or off 29 Section 2 Pump Setup and Programming WARNING When the Air Detector is turned off the pump will not detect air in the fluid path Periodically inspect the fluid path and remove any air to prevent air embolism Air embolism could result in death or serious injury to the patient e If you need to change the Air Detector setting see Section 4 Biomed Functions e Press wer 11 Verify the Upstream Sensor status e Make sure the desired setting is displayed This screen will show
21. VO feature allows you to deliver a minimal amount of drug between doses to maintain catheter pa tency You may also delay the start of dose delivery using the Dose Starts In feature Volume ml Time 19 Section 2 Pump Setup and Programming Programming Screens for Continuous Delivery These are the programming screens for the CADD Legacy PLUS pump in the continuous delivery mode Descriptions of the screens follow Reservoir Volume Reservoir Volume 164 68 ml D a S 5 Continuous Rate Continuous Rate a ml hr 5 4 ml Ap a D 4 o sx aA Given Given a o ml Saal Air Detector Off Air Detector On High or On Low On High Upstream Sensor eves Sensor Off or On On Reservoir Volume Enter the volume of fluid contained in a filled fluid container The Reservoir Volume value decreases as the pump delivers fluid or as you use prime the tubing When you change the fluid container reset the reservoir volume on this screen If you do not wish to use the Reservoir Volume feature scroll down to Not In Use located before 1 and after 9999 in the range of values The residual volume could be set higher than the capacity of the fluid container Be sure to program the reservoir volume to reflect the actual volume of the medication being used 20 Section 2 Pump Setup and Programming Continuous Rate Enter the continuous rate of medication delivery i
22. a Handling Software Safety Features sssccccssssescceses Annual Functional Inspection and Testing Procedures Inspection Procedures sierisesiresrissiiseiiineninis nininini Testing Procedures sescswessscnssevicatuins accunedcrervecsersdonsteutasaorentocks Occlusion Pressure Range Tests ssssessrsercrssseressseresssseersssses Accuracy Lest caterer KE R E ERE TE eines EEE E E ENE A T E E AS Limited Warranty x saccscescsceseencectvncinesnsiennaseeavnceniatemcencenesanondeeniecs 43 43 43 44 44 45 45 46 47 48 Section 1 General Description 1 0 General Description Introduction The CADD Legacy PLUS ambulatory infusion pump provides measured drug therapy to patients in hospital or outpatient settings Therapy should always be overseen by a physician or a certified licensed healthcare professional As appropriate to the situation the patient should be instructed in using and troubleshooting the pump g 0 un fa ES fe Indications The CADD Legacy PLUS pump is indicated for intravenous intra arterial subcutaneous intraperitoneal epidural space or subarach noid space infusion The pump is intended for therapies that require a continuous or intermittent rate of infusion Epidural Subarachnoid Administration The selected drug must be used in accordance with the indications included in the package insert accompanying the drug Administra tion of any drug by this pump is limited by any
23. appear on the display Refer to the Messages and Alarms Table in Section 5 WARNING Prior to starting infusion inspect the fluid path for kinks a closed clamp or other upstream obstructions and remove all air to prevent air embolism An undetected upstream occlusion may result in under or non delivery of medication and depending upon the type of medication being delivered could result in death or serious injury to the patient Air embolism could result in death or serious injury to the patient Bulyessdo ot 3 D v 3 5 To start the pump 1 Press and hold i Three sets of dashes appear on the display then they disap pear one by one each accompanied by a single beep 2 Release after the last set of dashes disappears and the pump beeps All of the programming screens appear for your review one after the other Stopping the Pump Stopping the pump stops delivery When the pump is stopped STOPPED will appear on the main screen and you will hear three beeps every 5 minutes To stop the pump 1 Press and hold i 43 Section 3 Operating the Pump Three sets of dashes will appear one by one on the pump s display each accompanied by a single beep 2 Release after the third set of dashes appears and the pump beeps Turning the Pump On Off When the pump is stopped you may put the pump into a low power state by turning it off The pump may be turned off when it is discon nected
24. assette Reservoir in a microwave oven as this may damage the medication the Medication Cas sette Reservoir or cause leakage Attach the cassette the part of the Medication Cassette Reser voir or CADD Administration Set that attaches to the pump properly An improperly attached or detached cassette could result in unregulated gravity infusion of medication from the fluid container or a reflux of blood e Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism e Ensure that the entire fluid path is free of all air bubbles before connecting to the patient to prevent air embolism e Prior to starting infusion inspect the fluid path for kinks a closed clamp or other upstream obstructions and remove any air to prevent air embolism Cautions e Do not operate the pump at temperatures below 2 C 36 F or above 40 C 104 F e Do not store the pump at temperatures below 20 C 4 F or above 60 C 140 F Do not store the pump with the Medication Cassette Reservoir or CADD Administration Set attached Use the Protective Cassette provided e Do not expose the pump to humidity levels below 20 or above 90 relative humidity e Do not store the pump for prolonged periods with the batteries installed e Do not immerse the pump in cleaning fluid or water or allow solution to soak into the pump accumulate on the keypad or enter t
25. ayed The Dose Starts in screen shown with hrs min allows the user to reset the time after which the dose should start Dose Starts in The Dose Starts in screen allows you to delay the start of delivery up to four days by allowing you to select the amount of time after which the first dose should begin The pump must be running after the selected delay in order for delivery to begin If a delayed start is not desired program the Dose Starts in to Immediate so that delivery will begin as soon as you start the pump The delay of the start of the next dose can be programmed in Lock Level 0 or Lock Level 1 at any time but if a dose is in progress this will cancel the remainder of the dose 26 Section 2 Pump Setup and Programming Given This screen shows the total amount of drug delivered since the last time this value was cleared The amount shown is rounded to the nearest 0 01 ml If this value reaches 99999 95 it automatically returns to 0 and continues counting The Given amount does not include drug delivered with the priming feature Air Detector This screen indicates whether the Air Detector is on high sensitivity low sensitivity or turned off The Air Detector status cannot be changed without entering the Biomed Functions Code see Section 4 Biomed Functions to change the setting as e Ce o 3 E gt ite 79 dnyas duing Upstream Sensor Status This screen indicates whe
26. c Section 5 Reference Technical Description Standards used in Development of the Pump The following standards were used in whole or part in the develop ment of the pump 56 Medical Electrical Equipment IEC 60601 1 Medical Electrical Equipment Part 1 General Re quirements for Safety IEC 60601 1 1 Medical Electrical Equipment Part 1 General Requirements for Safety Collateral Standard Safety requirements for medical electrical systems IEC 60601 1 2 1993 General Requirements for Safety Part 2 Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 2nd Edition 01 June 1996 Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 4 Medical Electrical Equipment Part 1 General Requirements for Safety 4 Collateral standard Programmable electrical medical systems IEC 60601 2 24 Medical Electrical Equipment Part 2 Particular Requirements for the Safety of Infusion Pumps and Controllers Electromagnetic Compatibility RTCA DO 160C Radiated Emissions Only Category A amp Z Limit CISPR11 Radiated and Conducted Emissions Group 1 Class B CISPR14 Radiated and Conducted Emissions device powered by AC adapter only For CISPR11 and CISPR14 tests the pump was fitted with an administration set with its inlet connected to a 250 ml bag and its outlet routed back to the ba
27. cassette the part of the Medication Cassette Reservoir or CADD Administration Set that attaches to the pump properly An improperly attached or detached cassette could result in unregulated gravity infu sion of medication from the fluid container or a reflux of blood which could result in death or serious injury to the patient ay ie ite o g E S Ce 79 dnyas A You must use a CADD Extension Set with Anti Siphon Valve or a CADD Administration Set with either an inte gral or an Add On Anti Siphon Valve to protect against unregulated gravity infusion that can result from an improp erly attached cassette 5 Gently twist push and pull on the cassette to make sure it is firmly attached If the cassette is not secure repeat the procedure from step 1 33 Section 2 Pump Setup and Programming Priming the Tubing and Connecting to the Patient The pump must stopped and in LLO or LL1 in order to prime the fluid path If the pump is in LL2 you cannot prime the fluid path NOTE If you are not changing the fluid container but wish to prime the fluid path you may follow the same procedure WARNING Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism which could result in death or serious injury to the patient 1 Make sure the tubing is disconnected from the patient and the tubing clamp is open
28. ccuracy The pump must be in Lock Level 0 LLO to perform the following inspections and tests NOTE Persons performing the following tests and procedures should be familiar with the CADD Legacy pump Please read the entire Operator s Manual before proceeding CAUTION CADD Legacy 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 Legacy pumps must be performed by Deltec or its authorized agents Inspection Procedures Visual Inspection e Visually inspect the pump for any damage to the LCD occlusion sensor seals valves and expulsor pump hinge area lock cassette sensor keypad indicator light power jack accessory jack air detector and housing 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 damage If the battery contacts appear corroded clean them with a cotton swab and isopropyl alcohol see Cleaning the Battery Contacts If the battery contacts appear to be bent or pushed in straight ening may be possible with a small screwdriver or other 68 Section 5 Reference suitable tool Care must be taken not to damage the pump housing or to incur further damage to the contacts Mechanical Inspection e
29. charge except for a minimal charge for postage and handling any Pump not including accessories which is defective if a claim is made during such one year period The following conditions procedures and limitations apply to the Manufacturer s obligation under this warranty A Parties Covered by this Warranty This warranty extends only to the Original Purchaser of the Pump This warranty does not extend to subsequent purchasers The Original Purchaser may be a patient medical personnel a hospital or institution which purchases the Pump for treatment of patients The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase B Warranty Performance Procedure Notice of the claimed defect must be made in writing or by telephone to the Manufacturer as follows SIMS Deltec 1265 Grey Fox Road St Paul MN 55112 U S A 1 800 426 2448 or SIMS Graseby Ltd WD2 4LG UK 44 0 1923 246434 Notice to the Manufacturer must include date of purchase model and serial number and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE PUMP If authorized the Pump must be properly and care fully packaged and returned to the Manufacturer postage prepaid Any loss or damage during shipment is at the risk of the sender C Conditions of Warranty The warranty is vo
30. death or serious injury to the patient NOTE If the fluid path contains an air eliminating filter it is acceptable for air bubbles to be present on the vent side of the filter 37 Section 2 Pump Setup and Programming Setting the Lock Level for the Patient The Lock Level must be changed to LL1 or LL2 to prevent the patient from having complete access to all programming and oper ating functions NOTE You may change the lock level at any time by stopping the pump and following the procedure below To change the lock level 1 Press Cow 2 The current lock level will appear 3 Press AN or y until the desired lock level LL1 or LL2 appears 4 Press again or GB Code 0 will appear 5 Press or y until the Lock Level Code 65 appears 6 Press or to set the new lock level oD a S 3 OE a8 ES a A WARNING Do not disclose to the patient the pump s security codes or any other information that would allow the patient complete access to all programming and operat ing functions Improper programming could result in death or serious injury to the patient 38 Section 2 Pump Setup and Programming CDM Programming with Upper Limits Adjusting Rate in Lock Level 1 This feature may be used in the continuous delivery mode only If a prescription allows for the Continuous Rate to be adjusted during the course of therapy you may wish to operate the pump in LL1
31. default settings 1 With the pump stopped and in LLO access Biomed Func tions Refer to the beginning of the Biomed Functions section for instructions on how to access Biomed Functions 2 Press Ger until Delivery Mode appears 3 Press or y to select Continuous or Intermittent 4 Press to enter the change 48 5 0 Reference Section 5 Reference Messages and Alarms Alphabetical List Messages and Alarms Description Corrective Action Air In Line Detected TWO TONE ALARM The Air Detector has detected air in the fluid path the fluid path may contain air bubbles or the tubing may not be fully threaded through the Air Detector Press or wr to silence the alarm then e Make sure the tubing is threaded properly e If the fluid path contains air bubbles close the clamps and disconnect the fluid path from the patient Then follow the instructions for removing air by priming the pump described in Section 2 Restart the pump Battery Depleted TWO TONE ALARM The battery power is too low to operate the pump The pump is now stopped e Change the batteries immediately e Press and hold to restart the pump Battery Removed Pump won t run TWO TONE ALARM With the AC adapter attached the AA batteries have been removed while the pump is running or you have tried to start the pump with depleted batteries The pump is now stopped Press or wen to silence the alarm
32. 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 1 0 volts 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 depleted batteries with new ones will clear the condi tion EPET ETER 65 g g g T oc Section 5 Reference 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 series of bit patterns 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
33. e Change the batteries soon Messages and Alarms Section 5 Reference Description Corrective Action Motor Locked remove all power TWO TONE ALARM Batteries are depleted and the pump was powered up with the AC Adapter Install new AA batteries reconnect the AC adapter and restart the pump No Disposable clamp tubing TWO TONE ALARM The disposable CADD Administration Set or Medication Cassette Reservoir was removed Clamp the tubing immedi ately A CADD Administration Set or Medication Cassette Reservoir must be properly attached in order for the pump to run Press or wr to silence the alarm No Disposable Pump won t run TWO TONE ALARM You have tried to start the pump without a disposable CADD Administration Set or Medication Cassette Reservoir attached A CADD Administration Set or Medication Cassette Reservoir must be properly attached in order for the pump to run Press or wer to silence the alarm Power lost while pump was on TWO TONE ALARM The pump was on and running when power was removed Stop the pump before changing the battery or removing the power source Press or er to silence the alarm Programming Incomplete TWO TONE ALARM WHEN STARTING THE PUMP A rate or dose must be programmed to start the pump Press or er to silence the alarm EPES ETER Reservoir Volume Empty TWO TONE ALARM The Reservoir Volum
34. e Protection Splashproof IPX4 57 Section 5 Reference Pump Alarms Maximum Infusion Pressure Maximum Time to Occlusion Alarm Bolus Volume at Occlusion Alarm PRESSURE ss sssdectessciestedseeeiecees Power Sources D e c g o oO cc System Operating Temperature 58 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 key stuck disposable detached 40 0 psi 2 76 bar CADD Administration Set with anti siphon valve 2 0 hours 0 050 ml resolution CADD Administra tion Sets Medication Cassette Reser voirs lt 0 15 ml Two AA alkaline batteries AC Adapter The expected life of two AA batteries is 15 hours at 125 ml hour or approxi mately 14 days at 10 ml day nominal This estimate is based on laboratory tests conducted at room temperature using two new batteries Actual battery life will vary depending on the brand of battery battery shelf life temperature conditions and delivery rate It is recommended that two new AA batteries be kept available for replacement if necessary 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
35. e a CADD Extension Set with Anti Siphon Valve 5 Start the pump and run at 50 ml hr 6 Slowly increase the backpressure 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 between 12 and 40 psi 26 14 psi between 0 82 and 2 76 bar 1 79 0 97 bar 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 Section 5 Reference Accuracy Tests Gravimetric Accuracy Testing Description A Medication Cassette Reservoir is partially filled with water and weighed then attached to a pump that is set to deliver a certain amount of water The Medication Cassette Reservoir 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 technical specifications section for the pump That is under the test conditions described below the accuracy of the pump and Medication Cassette Reser voir will be nominal with a 90 confidence level The nominal test conditions are as follows degassed water at 25 5 C without back pressure Equipm
36. e has reached 0 0 ml Press or e to stop the alarm Then install a new fluid container if appropriate and reset the reservoir volume 51 Section 5 Reference Messages and Alarms Description Corrective Action RUN ResVol Low THREE SINGLE BEEPS The Reservoir Volume is low Change the fluid container soon See Reservoir Volume Alarm in Section 1 for more information Service Due TWO TONE ALARM Service is due for this pump based on clock battery age or total motor revolu tions This screen will appear while in LLO only for 60 days and then in all lock levels until returned for service Upstream Occlusion TWO TONE ALARM Fluid is not flowing from the fluid container to the pump Check for a kink in the tubing or a closed clamp between the fluid container and pump Press or to stop the pump and silence the alarm for 2 minutes then remove the obstruction and press to restart the pump Value not saved D e c g o oO cc 52 A value was not saved by pressing i Press C to resume programming Verify all programming screens before moving to the next screen or starting the pump Section 5 Reference Cleaning the Pump and Accessories CAUTION e 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 Moisture build up inside the pump may damage the pump e Do n
37. e to state 85 5 oi 2 D A o Deltec SIMS Deltec Inc St Paul MN 55112 U S A QS SMITHS INDUSTRIES SHS Medical Systems U S Distribution SIMS Deltec Inc 1265 Grey Fox Road St Paul Minnesota 55112 U S A 1 800 426 2448 European Representative SIMS Graseby Ltd WD2 4LG UK 44 0 1923 246434 2000 SIMS Deltec Inc All rights reserved Printed in U S A 2000 03 40 3934 51D
38. ent needed 50 or 100 ml Medication Cassette Reservoir 50 or 60 ml syringe CADD Extension Set with Anti Siphon Valve A balance accurate to 0 1 g 40 ml of room temperature water Procedure 5 u D A m 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 77 3 5 g o v cc Section 5 Reference 10 T1 78 lock connector Secure the slide 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 Medication Cassette Reservoir extension set and record the weight This is the predelivery weight This weight includes the empty Medication Cassette Reservoir extension set and weight of the water Attach the cassette to the pump Program the Reservoir Volume to 20 ml Now press amp This value is the in tended delivery volume One ml of water at 20 C weighs 1 gram Remove the slide clamp With the pump in Lock Level 0 program a Continuous Rate of 125 ml hr Start the pump and wait for the reservoir volume empty alarm The pump will deliver 20 ml Again
39. ered This is the actual delivery volume 7 Find the difference between the actual delivery volume 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 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 SIMS Deltec or SIMS Graseby Ltd Example Actual Delivery Volume 19 5 ml Intended Delivery Volume 20 0 ml Inaccuracy Volume 0 5 ml Inaccuracy Volume 0 5 ml 5 Intended Delivery Volume 20 0 ml z Accuracy Error 0 025 g Accuracy Error 0 025 8 x 100 00 Accuracy Error Percentage 2 5 81 g g 2 v oc Section 5 Reference Index Bold page numbers indicate figure references A AC Adapter 6 7 AC indicator light 4 accessory jack 3 4 accuracy tests 62 63 gravimetric 77 volumetric 80 Administration Set 6 attaching 32 cautions vi warnings iv Air Detector 4 16 46 61 inserting tubing into 36 status screen 21 22 27 29 30 testing 72 73 warning iv alarms 49 52 58 anesthetics caution vii Anti Siphon Valve 6 warning iv arrow keys 4 5 batteries AA 7 11 15 57 58 cautions vi installing 11 15 warnings v battery compartment 4 7 battery contacts cleaning 54 battery internal clock 58 battery life 15 5
40. f WARNING When the Upstream Occlusion Sensor is turned off the pump will not detect occlusions upstream between pump and fluid container Periodically inspect the fluid container for decreasing volume inspect the fluid path for kinks a closed clamp or other upstream obstructions Upstream occlusions could result in under or non delivery of medications If undetected these occlusions could result in death or serious injury to the patient e If you need to change the Upstream Occlusion Sensor setting see Section 4 Biomed Functions e Press Qer 7 Review the program Press Qer repeatedly to review the programming screens If you need to reprogram a setting press wer until the appropriate screen appears and change the setting as described in this section 23 Section 2 Pump Setup and Programming Programming Screens for Intermittent Delivery These are the programming screens for the CADD Legacy PLUS pump in the intermittent delivery mode Descriptions of the screens follow Reservoir Volume Reservoir Volume 1646 4 ml D af z Dose Volume Dose Uol ume No 4 8 ml a gt E J ee ao Dose Duration Dose Duration e hrs 38 min Dose Cycle f Dose Cycle 64 hes AA min KVO Rate KUD Rate 4 8 ml he Dose Remaining Dose Remaining AA hrs 15 min Dose Starts in Dose Starts in 3 hes 15 min Given iven 2 8 ml 24 Section 2 Pump Set
41. f the infusion system plotted against given time periods Flow rate immediately following startup Time Interval 0 5 min Total Time 120 min Programmed Rate 24 0000 ml hr Cassette used CADD Administration Set with Flow ml hr anti siphon valve T min Short term flow rate error Programmed Rate 24 0000 ml hr Average Flow Rate 23 9227 ml hr Mean Flow Error 0 32 Cassette used CADD Administration Set with anti siphon valve v z 10 o 2 51 Error ee Sat ee of Flow Se 5 4 10 22 38 62 p as 5 11 19 31 min T min 62 Section 5 Reference Flow rate immediately following startup Time Interval 15 min Total Time 1500 min Programmed Rate 0 1 ml hr Cassette Used CADD Administration Set with anti siphon valve 0 20 7 i nth oa oO a Short term flow rate error Programmed Rate 0 1 ml hr Average Flow Rate 0 0989 ml hr Mean Flow Error 1 05 Cassette Used CADD Administration Set with anti siphon valve of _ Epmin 5 ae de 4 10 22 38 62 p 2 5 11 19 31 min T min 63 g g g v oc Section 5 Reference Safety Features and Fault Detection Hardware Safety Features Key hardware safety features include a watchdog timer circuit motor driver and motor watchdog circuits and a voltage detector circuit Each safety circuit performs a unique function to insure the overall safety of the device
42. from the patient and it is going to be stored for short periods of time CAUTION Do not store the pump for prolonged periods of time with the batteries installed Battery leakage could damage the pump To turn the pump off e Press and hold GY Three sets of dots will appear one by one on the pump s display each accompanied by a single beep oga Eg 5 a a2 on To turn the pump on e Press and hold Ce The pump will power up and auto matically review all screens Resetting Reservoir Volume To reset the Reservoir Volume to the value programmed in LLO the pump may be in any lock level 1 Stop the pump 2 Press er to display the Reservoir Volume screen 3 Press to reset the volume to the programmed value 44 Section 4 Biomed Functions 4 0 Biomed Functions Overview Accessing the Biomed Functions The Biomed Functions are pump configurations that are less fre quently changed The Biomed Functions are accessible only when the pump is stopped and in Lock Level 0 To Access the Biomed Functions 1 Press ocr The current lock level will appear 2 Press or Ge Code 0 will appear 3 Press or Y until the Biomed Functions Code 165 appears Lock Level Code 100 Then press or GH WARNING Do not disclose to the patient the pump s security codes or any other information that would allow the patient complete access to all programming and operat ing functio
43. g and operation of the CADD Legacy infusion system U S Distribution European Representative SIMS Deltec Inc SIMS Graseby Ltd 1265 Grey Fox Road WD2 4LG UK St Paul Minnesota 55112 U S A 1 800 426 2448 44 0 1923 246434 CADD Medication Cassette Reservoir design CADD Legacy and Medication Cassette are SIMS trademarks The symbol indicates it is registered in the U S Patent and Trademark Office and certain other countries DURACELL is a registered trademark of DURACELL Inc EVEREADY ENERGIZER is a registered trademark of Union Carbide Corp Super Sani Cloth is a registered trademark of Professional Disposables Inc 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 patent s pending Read this entire Operator s Manual before operating the CADD Legacy ambulatory infusion pump Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient Warnings This Operator s Manual should be used by clinicians only Do not permit patients to have access to this manual as the informa tion contained would allow the patient complete access to all programming and operating functions Improper programm
44. g forming a closed loop system A total of six feet of tubing was used to form the closed loop IEC 61000 3 2 Harmonic Distortion Class A equipment only for devices powered 220 VAC or greater Section 5 Reference IEC 61000 3 3 Voltage Functions and Flicker only for devices powered 220 VAC or greater IEC 61000 4 2 8 kV contact discharge 15 kV air discharge IEC 61000 4 3 Radiated Susceptibility 26 MHz to 2500 MHz 10 V m 1 kHz 80 AM modulation IEC 61000 4 4 AC Fast Transients at 500 volts 1000 volts and 2000 volts AC mains plug IEC 61000 4 5 AC Surges 1 kV differential mode 2 kV common mode IEC 61000 4 6 Conducted Disturbances AC mains plug 3V 150 kHz 80 MHz IEC 61000 4 8 AC Magnetic field at 400 Amperes meter at 50 Hz IEC 61000 4 11 AC Steady State Dropout amp Slow Sags Surges ENV 50204 Digital Radio Telephone 10 V m 900 5 MHz 50 duty cycle and 200 rep frequency Specifications Nominal General Pump Specifications Resolution ossee Medication Cassette Reservoir or CADD Administration Set 0 050 ml per pump stroke nominal SEn A 4 1 cm x 9 5 cm x 11 2 cm 1 6 in x 3 8 in X 4 4 in excluding cassette or other accessories Ed Weight vesens 392 g 13 8 oz including two AA T batteries empty 100 ml Medication Cassette Reservoir and excluding other al accessories Classification IEC 601 1 ccrcdhencogeen CF Y Class 11 E Moistur
45. gs iv Reservoir Volume 8 10 20 22 25 28 34 51 52 58 60 resetting 44 safety features hardware 64 software 66 67 security codes Biomed Functions Code 9 45 Lock Level Code 9 17 38 service due 52 software version ii 16 specifications Biomed Functions 61 general 57 standards 62 starting the pump 43 stopping the pump 43 subarachnoid administration warning iv symbols 3 syringe warning iii system definition 59 T turning pump on off 44 U a2uaJajoy ultrasound 55 caution vi 55 Upstream occlusion sensor 7 21 23 27 47 61 testing 73 W warnings and cautions iii vii 83 S i g o CY cc Section 5 Reference Limited Warranty SIMS Deltec Inc the Manufacturer warrants to the Original Purchaser that the infusion pump the Pump not including accessories shall be free from defects in materials and work manship under normal use if used in accordance with this Operator s Manual for a period of one year from the actual date of sale to the Original Purchaser THERE ARE NO OTHER WARRANTIES This warranty does not cover normal wear and tear and maintenance items and specifically excludes batteries administration sets extension sets or any other accessory items or equip ment used with the Pump Subject to the conditions of and upon compliance with this Limited Warranty the Manufac turer will repair or replace at its option without
46. he Air Detector groove Start the pump The pump should deliver without activation of the air detection alarm Upstream Occlusion Sensor Test Verify the Upstream Occlusion Sensor is turned On see Section 4 Biomed Functions 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 appro priate 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 EPET ETET Clamp the tubing halfway between the IV bag and the pump The pump should alarm within three activations after clamping the tubing 73 D 5 c g o v cc Section 5 Reference Occlusion Pressure Range Tests Occlusion Pressure Range Test Description Pressure is generated by activating the pumping mechanism with an attached filled clamped Medication Cassette Reservoir The pump is started and fluid is injected until the high pressure alarm sounds Equipment needed 50 or 100 ml Medication Cassette Reservoir containing distilled water 1 ml syringe Procedure 1 Insert two AA batteries or turn pump on and wait for the pump to power up 2 Attach a Medication Cassette Reservoir containing water to the pump 3 Prime the Medication Cassette Reservoir tubing The tubing should be f
47. he battery compartment e Do not clean the pump with acetone other plastic solvents or abrasive cleaners e Do not expose the pump to therapeutic levels of ionizing radia tion e Do not expose the pump directly to ultrasound vi Do not use the pump in the vicinity of magnetic resonance imaging MRI equipment Do not use the pump near ECG equipment Do not sterilize the pump Do not use the pump in the presence of flammable anesthetics or explosive gases Use only Deltec accessories as using other brands may adversely affect the operation of the pump CADD Legacy 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 Legacy pumps must be performed by Deltec or its authorized agents Check appropriate medication stability for time and temperature to assure stability with actual pump delivery conditions vii viii Table of Contents Warnings Cautions iii vi Section 1 General Description Introduction a pacassiard canta caotaarceaetesanesqnedeqnsanasesmteduiontadeoearsesanceatatas Indications sscisnssssarnnaannmsiamineiinnannoeusiexeienianeineiD Epidural Subarachnoid Administration c ccssesssnesesvessscceses STON Ge eeen ee E EEEE E EE EAE E Pump DIA STAI ssssccasucewsssceasecasscvennseosasetensdadeckeodnasdeseancenavechadoeres Descriptio
48. id if the Pump has been 1 repaired by someone other than the Manufacturer or its authorized agent 2 altered so that its stability or reliability is affected 3 misused or 4 damaged by negligence or accident Misuse includes but is not limited to use not in compliance with the Operator s Manual or use with nonapproved accesso ries The Pump is a sealed unit and the fact that the seal has been broken will be considered conclusive evidence that the Pump has been altered or misused Removal or damage to the Pump s serial number will invalidate this warranty D Limitations and Exclusions Repair or replacement of the Pump or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer The following exclusions and limitations shall apply 1 No agent representative or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty expressed or implied 2 THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE PUMP FOR ANY PARTICULAR PURPOSE 3 The Pump can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the Pump for any particular medical treatment 4 All recommendations information and descriptive literature supplied by the Manufac turer or its agents are believed to be accurate and reliable but do not constitute warranties 84 Section 5 Reference E Computer Program License 1 The Pump is
49. illed with fluid to the end of the luer lock connector The system must be free from air bubbles for this test 4 Withdraw the plunger of the empty 1 ml syringe to the 1 0 ml marking Now attach the syringe to the end of the Medication Cassette Reservoir tubing 5 Start the pump 6 When the pump is running slowly depress the plunger of the syringe noting when the High Pressure alarm is acti vated 74 Section 5 Reference 7 The pump should alarm when the syringe is between 0 5 and 0 1 ml Occlusion Pressure Range Test Il Description An adjustable metered pressure source is connected to the Medication Cassette Reservoir tubing The pressure is slowly increased until the high pressure alarm sounds Equipment needed Pressure gauge 40 1 psi 2 76 0 07 bar Pressure vessel partially filled with water Pressure regulator 40 psi 2 76 bar 50 or 100 ml Medication Cassette Reservoir containing water Procedure 1 Insert two AA batteries and wait for the pump to power up 2 Attach a Medication Cassette Reservoir to the pump NOTE The pressure from the source must be zero when the cassette is attached 3 Assemble the apparatus as shown EPET ETER 40 PSI 2 76 bar Regulator Pressure Gauge 75 eD s c g o YY cc Section 5 Reference 76 4 Connect the Medication Cassette Reservoir outlet tube to the metered pressure source NOTE Do not us
50. ime it is turned on If the motor runs for more than an average of 3 seconds the circuit will time out and disable 64 Section 5 Reference 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 with out 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 The software verifies this function during the watchdog test described above 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 2 4 volts when the motor is off or 1 8 volts when the motor is active An Analog to Digital Converter ADC built into the microprocessor allows the microprocessor via soft ware to monitor the battery voltage At the Low Battery Warning threshold the microprocessor enables a periodic series of beeps and displays a low battery warning message on the LCD As the voltage operating the motor reaches a nominal value of 4 75 volts the software
51. in menu Reservoir Volume Empty Alarm Check e Program the Reservoir Volume to 1 0 ml Press wer until Reservoir Volume is displayed on the LCD Press or y until 1 0 ml is displayed Then press ER e Press and hold until three series of dashes appear Release rme Press and hold tue The pump should prime ten double activations and then stop The pump will alarm and display Reservoir Volume Empty Press wen Starting Stopping the Pump e Program the pump with the following values Reservoir Volume 1 0 ml Continuous Rate 50 ml hr Given 0 00 press GD e Program the Air Detector Off see Section 4 Biomed Func tions e Press and hold G Starting appears followed by three sets of dashes each accompanied by a beep A review of the programmed parameters then appears The main screen should appear with RUN in the display EPET ETET e To stop the pump press and hold D 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 71 Section 5 Reference Activation Timing Check e Reprogram the Reservoir Volume to 1 0 ml and clear the Given screen e Press and hold until three dashed disappear from the display The pump should sequentially display all of the programmed values Start a timer at the first motor activa tion e Count the activations One activation sh
52. ing could result in death or serious injury to the patient For those patients who are likely to be adversely affected by unintended operations and failures including interrupted medi cation or fluid delivery from the device close supervision and provision for immediate corrective action should be provided If the pump is used to deliver life sustaining medication an additional pump must be available The pump is not to be used for delivery of blood or cellular blood products If the pump is dropped or hit inspect the pump for damage Do not use a pump that is damaged or is not functioning properly Contact Customer Service to return a pump for service Use of a syringe with the CADD Administration Set may result in UNDER DELIVERY of medication Syringe function can be adversely affected by variations in plunger dimension and lubric ity which can result in greater force required to move the syringe plunger A syringe plunger will lose lubrication as it ages and as a result the amount of under delivery will increase which could on occasion be significant Therefore the type of medication and delivery accuracy required must be considered when using a syringe with the CADD pump Clinicians must regularly compare the volume remaining in the syringe to the pump s displayed values such as RES VOL and GIVEN in order to determine whether under delivery of medica tion is occurring and if necessary take appropriate action Sy
53. ing Rate in Fock LEVEE eree e E a IDM Stopping the Pump During the Dose sscsissccsseesveseseuesees Section 3 Operating the Pump Starting the PUMP op cescccocesuncenensancencsdenizosenantesauncataaneadonebasadsnsenens Stopping the PUMP nccuracsscenedieed oceanencennansncesilennncssimardconcmnieteueeuchacs Turning the Pump On Off cccssiecssvns cscsccnevstawecercvotesnecssscntsnvexsenen Resetting Reservoir Volume joconecesvutessecdoestnnrcesndedounvanevevencee Section 4 Biomed Functions Overview Accessing the Biomed Functions ssssssssssssssessssessseese Air Detector On OM so3oecacicaccconseeentencidaadvceces deasksciedudaceutldedsdnadieess Upstream Sensor On Off xcacescverscostncnntmesacnssseasnnnadsoseiaccwasenemesnnss Changing the Delivery Method sssssssessseesessesessesssssssesssessseessresse Section 5 Reference Messages and Alarms Alphabetical List 0esecsccssssescsssess Cleaning the Pump and Accessories seerssssressesreessseseessssreessseeees Exposure to Radiation Ultrasound Magnetic Resonance Imaging MRI or Use near ECG Equipment cscssercesicccsesedues Technical Description icccdsverctsdussevantaiecensiuedinescbeuncevusucnieneanctuers Specifications Nominal ssid icoicecdeevacsiasncenencowenaiscenceanneteansenans Accuracy Test Results zarenian Safety Features and Fault Detection cccssssseceessneeeeeees Software Safety Features eesesesssesssssesresssreesssrecesssecesssssesee Dat
54. les twenty total wipes over the contact Using a clean surface of the swab repeat process for second battery contact Using a clean swab wetted with alcohol rub each battery contact again a minimum of four back and forth cycles eight total wipes over the contact Allow the contacts to dry completely before use Section 5 Reference Exposure to Radiation Ultrasound Magnetic Resonance Imaging MRI or Use near ECG Equipment CAUTION 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 func tion properly should be confirmed following treatment 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 magnetic fields 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 Do not use the pump near ECG equipment as the pump may interfere with the operation of the equipment Monitor ECG equipment carefully when using this pump a2uasajay 55 3 5 g o v c
55. level setting The pump will beep after each screen If messages appear see the Messages and Alarms Table in Section 5 of this manual for further explanation and instruction e When power up is complete six beeps will sound and the pump will be stopped on the main screen NOTE To move quickly through the power up screens press repeatedly To skip the automatic review entirely press Y If you attempt to skip screens before the pump is powered up it will not respond 16 Section 2 Pump Setup and Programming Changing to Lock Level 0 LLO Before programming the pump make sure the pump is set to LLO LLO allows the clinician to access all programming and operating functions 1 Make sure the pump is stopped Press ocr The current lock level will appear If the lock level is already LLO press Qer to exit 2 Press or until LLO appears 3 Press again or GB Code 0 will appear 4 Press or y until the Lock Level Code 65 appears ay D 3 3 5 Co 79 dnyas duing WARNING Do not disclose to the patient the pump s security codes or any other information that would allow the patient complete access to all programming and operat ing functions Improper programming could result in death or serious injury to the patient 5 Press or to set the new lock level 17 Section 2 Pump Setup and Programming Programming the Pump General Instructions
56. m obstructions Upstream occlusions could result in under or non delivery of medications Do not disclose to the patient the pump s security codes or any other information that would allow the patient complete access to all programming and operating functions Do not use rechargeable NiCad or nickel metal hydride NiMH batteries Do not use carbon zinc heavy duty batteries They do not provide sufficient power for the pump to operate prop erly Always have new batteries available for replacement If power is lost non delivery of drug will occur If the pump is dropped or hit the battery door tabs may break Do not use the pump if the battery door or tabs are damaged because the batteries will not be properly secured this may result in loss of power and non delivery of drug If a gap is present anywhere between the battery door and the pump housing the door is not properly latched If the battery door becomes detached or loose the batteries will not be prop erly secured this could result in loss of power and nondelivery of drug Close the fluid path tubing with the clamp before removing the cassette from the pump to prevent unregulated gravity infusion For detailed instructions and warnings pertaining to Medication Cassette Reservoir or CADD Administration Sets please refer to the instructions supplied with those products Frozen medication must be thawed at room temperature only Do not heat the Medication C
57. means of identification Drugs not intended for epidural or subarachnoid space infusion could result in death or serious injury to the patient Section 1 General Description Symbols y o IPX4 xp 2 8 amp Alternating Current Power Jack Accessory Jack Attention consult accompanying documents read Instructions for Use g oO wu A mE e Class II Equipment Type CF Equipment Splashproof water splashed against pump housing will have no harmful effects see Cleaning the Pump and Accessories Section 5 for additional important informa tion Date of Manufacture Catalog reorder number Serial Number Dispose of used batteries in an environmentally safe manner and according to any regulations which may apply Section 1 General Description Pump Diagram Display xe Power Jack 4 A Jack 5 ccessory Jac 3 AC Indicat X roni ndicator Light VIEW Air Detector 1 Keypad e D Cassette Power Jack symbol Threaded Mounting Accessory Hole Jack symbol ieai hl view View ORES Cassette Lock Section 1 General Description Description of the Keys Display and Features AC Indicator Light The green indicator light is on when you are using the AC adapter to power pump Display The Liquid Crystal Display LCD shows programming information and messages In this manual the term display is synonymous with display pa
58. n ml hr The maximum rate is 125 ml hr Given This screen shows the total amount of drug delivered since the last time the value was cleared The amount shown is rounded to the nearest 0 05 ml If this value reaches 99999 95 it automatically returns to 0 and continues counting The Given amount does not include drug used when priming the tubing Air Detector Status This screen indicates whether the Air Detector is on high sensitivity low sensitivity or turned off The Air Detector status cannot be changed without entering the Biomed Functions Code see Section 4 Biomed Functions to change the setting ay D 3 3 5 Co 33 dn s dund Upstream Sensor Status This screen indicates whether the Upstream Occlusion Sensor is turned on or turned off The Upstream Sensor status cannot be changed without entering the Biomed Functions Code see Section 4 Biomed Functions to change the setting Before programming in Continuous Delivery Mode e Stop the pump and change the Lock Level to LLO as de scribed in Section 1 e Select the Continuous Delivery Mode CDM as described in Changing the Delivery Methods in Section 4 If the pump is already in the CDM you may select it again to clear all programming screens to their default settings 21 Section 2 Pump Setup and Programming Programming Continuous Delivery Be sure the pump is in the continuous delivery mode versus the intermittent delivery mode To
59. n of the Keys Display and Features 0ssseereses The Main Scree iaccsie acted eea E deus Lock Levels sestssts seahceysiettedusiinatances euch isar ias o eR ies aae EES Security Codes cciscosessascvadiasssdecnesasenstaaesananagdeserndensauentenceorinenecddens Lock Level Table siduiciniiansndisteimnidnodimimmonrassaenionta Section 2 Pump Setup and Programming Installing or Replacing the Batteries x cssecs secadestacvesceavacdexsosceusdes Watching Power UP isisiceriesasiassedaccetauseneieieenrnsttieneanideteane Changing to Lock Level 0 LLO essessssssesssssssssssessssesseeessresssee Programming the Pump General Instructions sratisicccssndcsscicesectes Delivery Methods lt sachustscavwseanaxdcqurbinecxtesteieudseutspuinceshisenchecteocedsend Programming Screens for Continuous Delivery ssssssssessessessee Programming Continuous Delivery saiiisncsiechevencuscceacvarevateieceues Programming Screens for Intermittent Delivery eeseeeeees Programming in the Intermittent Delivery Mode eeeeeeeees Removing a Cassette csavciscciistecctacccttenssineceineestaeeeettisertesetasteeiav es Attaching a CASSEttG sessctacvecaccarnitan cesisenesetnseisaneiedeaaianeaanreds Priming the Tubing and Connecting to the Patient eee Inserting the Tubing into the Air Detector eeceeeeeeeeseeeeeeeeees Setting the Lock Level for the Patient 0ssescssesrrcssseseeressees CDM Programming with Upper Limits Adjust
60. nel or LCD g oO u A E e Keypad The keys on the keypad are described below A key beeps when pressed if it is operable in the current lock level starts and stops pump delivery silences alarms is used to enter save a new value in the pump s memory when programming pump settings or to clear values from record keeping screens It is also used to return from the Biomed Functions to the main screen Section 4 is used to fill the tubing and to remove air bubbles from the fluid path is used to view or change the pump s current lock level Lock levels are used to limit patient access to certain programming and operating functions See Lock Levels this section vem is used to move from one programming screen to the next without changing the setting or value displayed silences alarms allows you to scroll up or increase a value or scroll through Biomed Function settings allows you to scroll down or decrease a value or scroll through Biomed Function settings is used to put the pump into a low power state when not in use or back into full power lt D s o p Q v 7 O a Section 1 General Description Power Jack You may plug an AC Adapter into the Power jack as an alternate source of power The indicator light on the front of the pump will illuminate when the AC Adapter is in use Accessory Jack This jack is used for accessory cables See the Instruction
61. ns Improper programming could result in death or serious injury to the patient 4 Press er to select the setting you wish to view or change then follow the instructions in this section for the appropri ate screen pawolg n c gt Q e gt a NOTE To leave a Biomed Function unchanged press wer 5 To exit the Biomed Functions press er until you get to the screen that reads NEXT for Biomed ENTER for main 6 Press to return to the main screen 45 w 2 G 2 5 re Section 4 Biomed Functions Air Detector On Off The Air Detector screen can be set to On High On Low or Off WARNING When the Air Detector is turned off the pump will not detect air in the fluid path Periodically inspect the fluid path and remove any air to prevent air embolism Air embolism could result in serious injury or death to the patient 46 With the pump stopped and in LLO access Biomed Func tions Refer to the beginning of the Biomed Functions section for instructions on how to access Biomed Functions Press vem until Air Detector appears Use 2 or y to select On High On Low or Off e On high is the highest sensitivity where the smallest bubbles will be detected e On low is lower sensitivity where only the larger bubbles will be detected See Specifications in Section 5 Press to enter the change 8 Press to go to the next screen 8 Sec
62. on for delivery of the dose up to 24 hours You will not be able to select a duration that would cause the rate of delivery of the programmed Dose Volume to exceed 125 ml hr Entering a Dose Duration will automatically reset the Dose Cycle and set the Dose Starts in to Immediate 25 Section 2 Pump Setup and Programming Dose Cycle The cycle is the time from the start of one dose to the start of the next dose The programmable values for cycle are based on the Dose Duration There must be at least 5 minutes between the end of one dose and the start of the next therefore the minimum pro grammable cycle is the Dose Duration plus 5 minutes The maxi mum cycle is 96 hours Entering a cycle automatically sets the Next Dose Start Time to Immediate KVO Rate The KVO or Keep Vein Open rate is optional It allows the delivery of a drug to help maintain catheter patency The program ming range is 0 to 125 ml hr If the time the next Dose Starts in is programmed the KVO rate is active during the initial delay The KVO rate is also active between doses 8 Dd a 3 OE Aa ES ao Dose Remaining The Dose Remaining screen is displayed during dosing or if a dose was interrupted This screen displays the time in hours and minutes that are required to infuse the remaining portion of the dose NOTE If the dose is interrupted and the pump is stopped both the Dose Remaining and Dose Starts in screens will be displ
63. ons Upstream occlusions could result in under or non delivery of medications If undetected these 2 p Q 5 wn o a Section 1 General Description occlusions could result in death or serious injury to the patient Downstream Occlusion Sensor The pump contains a downstream occlusion sensor When a downstream occlusion between the pump and patient access site is detected an alarm will sound delivery will stop and the display will show High Pressure Reservoir Volume Alarm The Reservoir Volume alarm indicates when the fluid in the fluid container is low or depleted Each time you change the fluid container you may reset the Reservoir Volume to the originally programmed volume Then as medication is delivered the Reservoir Volume automatically decreases When the pump calculates that 5 ml remain in the fluid container beeps sound and ResVol Low appears on the main screen This alarm recurs at every subsequent decrease of 1 ml until the Reservoir Volume reaches 0 ml at which point the pump stops and the Reservoir Volume empty alarm sounds The Main Screen The main screen is the starting point for programming or viewing the pump s settings If no keys are pressed for a period of time 2 minutes the display reverts to the main screen When the two AA batteries are low LowBat appears on the main screen Battery Status When running Status of Reservoir Volume
64. or wer av ie ite o g 3 S ite 79 dnyas dung 5 Remove the cassette hooks from the pump hinge pins 31 Section 2 Pump Setup and Programming Attaching a Cassette Obtain a new filled Medication Cassette Reservoir or CADD Administration Set attached to a non vented flexible IV bag WARNING For detailed instructions and warnings pertaining to the Medication Cassette Reservoir or CADD Administration Set please refer to the instructions for use supplied with the product for preparing the product for use After attaching the cassette proceed to the Reservoir Volume screen to reset the value for the volume and then prime the tubing WARNING Frozen medication must be thawed at room tempera ture only Do not heat the Medication Cassette Reservoir in a microwave oven as this may damage the medication the Medica tion Cassette Reservoir or cause leakage oD T OE Ae Eo a a To attach the cassette to the pump 1 Clamp the tubing 2 Insert the cassette hooks into the hinge pins on the pump 3 Place the pump upright on a firm flat surface Press down so the cassette fits tightly against the pump 32 Section 2 Pump Setup and Programming 4 Insert a coin into the lock push in and turn counterclock wise until the line on the lock lines up with the arrow on the side of the pump and you feel the lock click into place WARNING Attach the
65. ot clean the pump with acetone other plastic solvents or abrasive cleaners as damage to the pump may occur Routinely clean the pump to keep it free of dirt liquids and foreign objects Use any of the following solutions to clean the pump and accesso ries Soap solution Benzalkonium Chloride concentrate 0 13 Glutaral Concentrate USP 2 10 percent solution of household bleach one part house hold bleach to nine parts water Alcohol USP 93 Isopropyl Alcohol USP 99 Chlorohexidine 70 PDI Super Sani Cloth Mada Medical MadaCide 1 Dampen a soft lint free cloth with cleaning solution and wipe the exterior surface of the pump Do not allow the solution to soak into the pump EPES ETER 2 Wipe the entire surface dry with another soft lint free cloth Allow the pump to dry completely before use 53 D e c g o v cc Section 5 Reference Cleaning the Battery Contacts Routinely clean the battery contacts possibly as part of the preven tative maintenance cycle to remove buildup of foreign material on the contacts Use the following to clean the battery contacts 54 Cotton swab wetted with Isopropyl Alcohol 70 mini mum NOTE Do not use an alcohol formulation that contains components other than alcohol and water OR Pre moistened alcohol swab Using a swab wetted with alcohol rub the entire battery contact for a minimum of ten back and forth cyc
66. ould occur every six seconds Approximately 66 seconds and ten activations later the Reservoir Volume empty alarm should occur The display should show Reservoir Volume empty GIVEN Check e Stop the pump by pressing and holding Ea Press om to advance to the Given screen The display should show 2 00 ml If the above steps have not been followed exactly a different value may appear e Press amp The display should now show 0 00 ml Air Detector Test e Turn the Air Detector On see Section 4 Biomed Functions e Reprogram the Reservoir Volume to 10 0 ml Press until Reservoir Volume is displayed on the LCD Press or Y until 10 0 ml is displayed Then press B D 5 c g o v cc e Attach an empty 50 or 100 ml Medication Cassette Reser voir or CADD Administration Set to the pump Secure it using the lock button e Thread the tubing through the Air Detector groove e Start the pump 72 Section 5 Reference 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 empty Medication Cassette Reservoir or CADD Adminis tration Set Now attach a Medication Cassette Reservoir containing fluid or a primed CADD Administration Set to the pump Lock the cassette Make certain that there is no air in the fluid path Secure it using the lock button Thread the tubing into t
67. program the pump enter the pre scribed values 1 Begin at the main screen e Make sure the pump is in LLO e Make sure STOPPED appears on the main screen e Press wer to begin 2 Enter the Reservoir Volume e Press or y to select the volume of a filled fluid con tainer If you do not wish to use the Reservoir Volume feature scroll down to Not In Use located before 1 e Press GH e Press wer 3 Enter the Continuous Rate e Press or y to select the desired rate e Press GH e Press Qer 4 Clear Given 8 D a 3 OE a8 ES i a A e Press if you wish to clear the amount given y 8 e Press er 5 Verify the Air Detector status e Make sure the desired setting is displayed This screen will show whether the Air Detector is turned on high or low 22 Section 2 Pump Setup and Programming or off WARNING When the Air Detector is turned off the pump will not detect air in the fluid path Periodically inspect the fluid path and remove any air to prevent air embolism Air embolism could result in serious injury or death to the patient e If you need to change the Air Detector setting see Section 4 Biomed Functions e Press Qer 6 Verify the Upstream Sensor status d Puiwwepo y c g M oa E Ro e Make sure the desired setting is displayed This screen will show whether the Upstream Occlusion Sensor is turned on or of
68. s for Use supplied with those accessories Air Detector The Air Detector is on the pump in the area shown in the diagram If air is detected in the part of the tubing that passes through the Air Detector an alarm sounds and delivery stops See Section 5 for Air Detector specifications If an Air Detector is not required it may be turned off See Section 4 Biomed Functions WARNING When the Air Detector is turned off the pump will not detect air in the fluid path Periodically inspect the fluid path and remove any air to prevent air embolism Air embolism could result in death or serious injury to the patient Cassette The cassette is the portion of the Medication Cassette Reservoir or CADD Administration Set that attaches to the bottom of the pump The following single use products are compatible with the CADD Legacy pump e Medication Cassette Reservoir 50 or 100 ml used with the CADD Extension Set with Anti Siphon Valve e CADD Administration Set with integral Anti Siphon Valve e CADD Administration Set with Add On Anti Siphon Valve WARNING You must use a CADD Extension Set with Anti Siphon Valve or a CADD Administration Set with either an integral or an Add On Anti Siphon Valve to Section 1 General Description protect against unregulated gravity infusion that can result from an improperly attached cassette Unregulated gravity infusion could result in death or serious injury
69. secure the slide clamp as close as possible to end of the extension set luer lock connector Remove the cassette from the pump and weigh the entire Medication Cassette 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 actual delivery volume and the intended 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 If the accuracy error percentage is greater than 6 repeat the test with a new Medication Cassette Reservoir If the Section 5 Reference pump fails a second time call SIMS Deltec or SIMS Graseby Ltd Example Predelivery Weight 61 1 g Postdelivery Weight 41 6 Weight of Amount Delivered 19 5 g 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 Accuracy Error 0 025 x 100 00 Accuracy Error Percentage 2 5 EPET ETER 79 D 5 c g o v cc Section 5 Reference 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
70. sm could result in death or serious injury to the patient av ie ite o g E S ite 79 dnyas dung NOTE If the fluid path contains an air eliminating filter it is acceptable for air bubbles to be present on the vent side of the filter 35 Section 2 Pump Setup and Programming Inserting the Tubing into the Air Detector WARNING When the Air Detector is turned off the pump will not detect air in the fluid path Periodically inspect the fluid path and remove any air to prevent air embolism Air embolism could result in death or serious injury to the patient See Section 4 Biomed Functions for instructions on how to turn the air detector on and off 1 If the Air Detector is in use make a small loop of tubing underneath the air detector and hold it with your thumb 2 Place the tubing over the groove in the air detector and tuck it under the catch oD oS Se OE a8 ES 5 gt a A Catch 36 Section 2 Pump Setup and Programming 3 To seat the tubing into the groove gently pull the tubing until it is under the retention nubs and flat in the groove Retention nubs ay To 2 D 3 3 5 Co 79 dnyas dung 4 Connect the tubing to the patient s infusion set or indwell ing catheter WARNING Ensure that the entire fluid path is free of all air bubbles before connecting to the patient to prevent air embolism Air embolism could result in
71. stem delivery inaccuracies may occur as a result of back pressure or fluid resistance which depends upon drug viscosity catheter size and extension set tubing for example microbore tubing Do not administer drugs to the epidural space or subarachnoid space unless the drug is indicated for administration to those spaces To prevent infusion of drugs that are not indicated for epidural space or subarachnoid space infusion do not use administration sets that incorporate injection sites If a Medication Cassette Reservoir CADD Extension Set or CADD Administration Set is used for drug delivery into the epidural or subarachnoid space clearly differentiate them from those used for other routes of infusion for example by color coding or other means of identification When the Air Detector is turned off the pump will not detect air in the fluid path Periodically inspect the fluid path and remove any air to prevent air embolism You must use a CADD Extension Set with an Anti Siphon Valve or a CADD Administration Set with either an integral or Add On Anti Siphon Valve to protect against unregulated gravity infusion that can result from an improperly attached cassette When the Upstream Occlusion Sensor is turned off the pump will not detect occlusions upstream between pump and fluid container Periodically inspect the fluid container for decreasing volume inspect the fluid path for kinks a closed clamp or other upstrea
72. ther the Upstream Occlusion Sensor is turned on or turned off The Upstream Sensor status cannot be changed without entering the Biomed Functions Code see Section 4 Biomed Functions to change the setting Before programming in Intermittent Delivery Mode e Stop the pump and change the Lock Level to LLO as de scribed in Section 1 e Select the Intermittent Delivery Mode IDM as described in Changing the Delivery Method in Section 4 If the pump is already in the IDM you may select it again to clear all programming screens to their default settings 27 Section 2 Pump Setup and Programming Programming in the Intermittent Delivery Mode Be sure the pump is in the intermittent delivery mode versus the continuous delivery mode To program the pump enter the pre scribed values 1 Begin at the main screen e Make sure the pump is in LLO e Make sure STOPPED appears on the main screen e Press vom to begin 2 Enter the Reservoir Volume e Press or 7 to select the volume of a filled fluid con tainer If you do not wish to use the Reservoir Volume feature scroll down to Not In Use located before 1 e Press Ge e Press vem 3 Enter the Dose Volume e Press or 7 to select the desired volume e Press ER e Press Qer NOTE The maximum rate of the pump is 125 ml hr The pump will only allow a dose duration that will not cause a rate greater than 125 ml hr for the programmed volume 8 D o
73. tion 4 Biomed Functions Upstream Sensor On Off The Upstream Occlusion Sensor screen can be set to On or Off If this screen is set to On and an upstream occlusion between pump and fluid container is detected an alarm will sound delivery will stop and the display will show Upstream Occlusion WARNING When the Upstream Occlusion Sensor is turned off the pump will not detect occlusions upstream between pump and fluid container Periodically inspect the fluid container for decreas ing volume inspect the fluid path for kinks a closed clamp or other upstream obstructions Upstream occlusions could result in under or non delivery of medications If undetected these occlu sions could result in death or serious injury to the patient 1 With the pump stopped and in LLO access Biomed Func tions Refer to the beginning of the Biomed Functions section for instructions on how to access Biomed Functions 2 Press wer until Upstream Sensor appears 3 Press AN or y to select Off or On 4 Press to enter the change n c Q e gt a 47 wn c 2 G LL Section 4 Biomed Functions Changing the Delivery Method Delivery can be changed between Continuous Delivery and Intermit tent Delivery This allows for either continuous drug delivery or infusion of a prescribed volume of a drug over a specified time period When the delivery method is changed programming will revert to
74. to the patient Threaded Mounting Hole The optional Polemount Bracket Adapter attaches to the threaded mounting hole in the back of the pump allowing you to hang the pump on an IV pole g 0 un A ES fe e Battery Compartment Two AA batteries fit into the battery compartment The AA batter ies serve as the primary source of power or as a backup when an AC Adapter is in use Cassette Lock This attaches the cassette the part of the Medication Cassette Reservoir or CADD Administration Set that attaches to the pump to the pump This allows you to secure the cassette to the pump If the cassette becomes unlocked while the pump is running delivery will stop and an alarm will occur If the cassette becomes unlocked while the pump is stopped an alarm will occur Other Features Not Shown Upstream Occlusion Sensor The pump contains an upstream occlusion sensor This feature may be turned on or off See Section 4 Biomed Functions When the sensor is turned on and an up stream occlusion between pump and fluid container is detected an alarm will sound delivery will stop and the display will show Upstream Occlusion WARNING When the Upstream Occlusion Sensor is turned off the pump will not detect occlusions upstream between pump and fluid container Periodically inspect the fluid container for decreas ing volume inspect the fluid path for kinks a closed clamp or other upstream obstructi
75. unt of time remaining in the current dose use the Dose Remaining screen in the programming loop Then stop the pump change to LLO or LL1 and reprogram the delay on the Dose Starts in screen Resuming the Dose To resume delivery of a dose that has been stopped in progress simply restart the pump Resetting the Cycle If you wish to reset the cycle stop the pump during KVO change to LLO or LL1 and reprogram the start of the Next Dose If a dose has been stopped in progress and you wish to cancel the current dose and reset the cycle make sure the pump is in Lock 40 Section 2 Pump Setup and Programming Level 0 or Lock Level 1 The Dose Remaining screen with the remaining hours and minutes of the dose will be displayed followed by the Dose Starts in screen Reprogram the Dose Starts in screen which will cancel the remainder of the dose and the next cycle will start after the delay you selected Stopping the pump during the KVO will not affect the start time of subsequent doses ay ie ite o 3 S Ce 3 dn s dund 41 Section 2 Pump Setup and Programming oD e OE moe D Eo aa 42 Section 3 Operating the Pump 3 0 Operating the Pump Starting the Pump When you start the pump programmed values will be automatically reviewed Then fluid delivery will begin as programmed and RUN will appear on the main screen If the pump will not start a message will
76. up and Programming On High or On Low On High Upstream Sensor Upstream Sensor Off or On On Reservoir Volume Enter the volume of fluid contained in a filled fluid container The Reservoir Volume value decreases as the pump delivers fluid or as you prime the tubing When you change the fluid container reset the reservoir volume on this screen If you do not wish to use the Reservoir Volume feature select Not In Use located before 1 and after 9999 in the range of values Air Detector Off Air Detector ay 2 D Ej 3 5 Co 33 dn s dund The reservoir volume could be set higher than the capacity of the fluid container Be sure to program the reservoir volume to reflect the actual volume of the medication being used Dose Volume Enter the volume of the dose in milliliters The maximum volume is 1000 ml Entering a Dose Volume will automatically reset the cycle and set the time that the Next Dose Starts in to Immediate If you enter a Dose Volume that would cause the rate to be greater than the maximum rate of 125 ml hr the pump will automatically lengthen the Dose Duration to accommodate the new volume You will then need to confirm the new Dose Duration or enter a differ ent duration The cycle may also be affected if the Dose Duration is lengthened in this case you would also need to confirm the new Dose Cycle or enter a different Dose Cycle Dose Duration Enter the durati
77. 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 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 display a system fault screen 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 a valid key press the software will disregard the key press The keyboard is designed with redundant 66 Section 5 Reference switches for and amp The software must detect that both switches are activated before taking any action 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
78. us injury to the patient eal x Rs 14 Section 2 Pump Setup and Programming 6 Resume operation of the current program by pressing and holding to start the pump or proceed to program the pump NOTE e The life of the batteries is dependent on the amount of medication delivered delivery rate battery age and the temperature e At the rate of one 50 ml Medication Cassette Reservoir per day alkaline batteries will usually last about seven days The power of the batteries will be quickly depleted at tem peratures below 10 C 50 F ay ie ite o g E S Ce 79 dnyas A CAUTION Do not store the pump for prolonged periods of time with the batteries installed Battery leakage could damage the pump 15 Section 2 Pump Setup and Programming Watching Power Up When you install the batteries the pump will start its power up sequence during which it performs self tests and displays pro grammed values Watch for the following e Pump model number and last error code LEC if any will appear e The software version will appear e The display will turn on showing a series of blocks Look for any blank areas which would indicate a faulty display e The display will turn off briefly 8 D oS SE OE a8 ES i a A e The pump s program screens will appear followed by screens showing the Air Detector status Upstream Occlu sion sensor status and lock
79. w batteries in the compartment making sure the battery strap is positioned correctly under the batteries NOTE e Be sure to match the polarity markings of the new batteries and with those labeled in the battery compartment If you put the batteries in backwards the display panel will be blank and you will not hear a beep 12 Section 2 Pump Setup and Programming e Use two new AA alkaline batteries to power the pump You may use any alkaline batteries including DURACELL Alkaline and EVEREADY ENERGIZER Alkaline for example 4 Place the battery door over the battery compartment and slide the door closed ay ie ite o 3 S ice 79 dnyas dung 5 Ensure that the door is latched by trying to remove the door without pressing the arrow button NOTE The power up sequence will start the pump will go through an electronic self test and the pump will beep six times at the end of the power up sequence All of the display indicators the software revision level and each parameter will appear briefly 13 Section 2 Pump Setup and Programming WARNING If a gap is present anywhere between the battery door and the pump housing the door is not properly latched If the battery door becomes detached or loose the batteries will not be properly secured this could result in loss of power nondelivery of drug and depending on the type of drug being administered death or serio

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