CADD Legacy Plus 6500 Operator's Manual
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CADD Legacy Plus 6500 Operator's Manual

Ambulatory infusion pump
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Legacy
Operator's Manual
CADD-Legacy
Ths Operator's Manual s for Clncan use
only. Read the entre Operator's Manual
This online version differs from the printed version.
Certain information that is not intended for patients
Ambulatory Infusion Pump
Model 6500
CONTINUOUS OR
INTERMITTENT DELIVERY
Rate is in
ml/hr
before operatng the pump.
has been removed.
PLUS
PLUS
®


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  • Page 1 Legacy PLUS Operator’s Manual CADD-Legacy PLUS ® Ambulatory Infusion Pump Model 6500 CONTINUOUS OR INTERMITTENT DELIVERY Rate is in ml/hr Ths Operator’s Manual s for Clncan use only. Read the entre Operator’s Manual before operatng the pump. This online version differs from the printed version.
  • Page 2 This manual pertains only to the CADD-Legacy® PLUS Model 6500 ambulatory infusion pump. There are other CADD-Legacy® pump models available; review the rear label of the pump to ensure it is a CADD-Legacy® PLUS Model 6500 pump before programming. This pump delivers medica- tion at a continuous rate or intermittent rate in milliliters per hour (ml/hr).
  • Page 3 Smiths Medical MD, Inc. 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 lubricity, which can result in greater force required to move the syringe plunger.
  • Page 4 • If a Medication Cassette Reservoir, CADD™ Extension Set or CADD™ Administration Set is used for medication 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.
  • Page 5 • 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 prod- uct for use.

  • Page 6: Cautions

    If you are using a CADD™ Administration Set or Medication Cassette Reservoir that does not have the flow stop feature (catalog number does not start with 21-73xx): You must use a CADD™ Extension Set with an integral Anti-Siphon Valve or a CADD™ Administration...
  • Page 7 • Do not expose the pump to humidity levels below 20% or above 90% relative humidity. • Do not store the pump for prolonged periods of time with the batter- ies installed. • Frozen medication must be thawed at room temperature only. Do not heat the Medication Cassette Reservoir in a microwave oven as this may damage the medication, the Medication Cassette Reservoir, or cause leakage.
  • Page 8 Check appropriate medication stability for time and temperature to assure stability with actual pump delivery conditions. • Information regarding the recommended Medication Cassette Reser- voirs, CADD™ Extension Sets, CADD™ Administration Sets and ac- cessories is available in the Product List that accompanies the CADD- Legacy® pump. v...

  • Page 9: Table Of Contents

    Table of Contents Warnings Cautions 1.0 General Description Introduction ......................1 Indications ......................1 Epidural/Subarachnoid Administration ............1 Symbols ........................3 Pump Diagram ....................4 Description of the Keys, Display, and Features ..........5 The Main Screen ....................8 Lock Levels ......................9 Security Codes ....................9 Lock Level Table ....................10 2.0 Pump Setup and Programming Installing or Replacing the Batteries .............11 Watching Power Up ..................16...
  • Page 10 3.0 Operating the Pump Starting the Pump ................... 43 Stopping the Pump ..................43 Turning the Pump On/Off ................44 Resetting the Reservoir Volume ..............44 4.0 Biomed Functions Overview: Accessing the Biomed Functions ..........45 Air Detector On/Off ..................46 Upstream Sensor On/Off ................47 Changing the Delivery Method ..............

  • Page 11: General Description

    As appropriate to the situation, the patient should be instructed in using and troubleshooting the pump. Indications The CADD-Legacy® PLUS pump is indicated for intravenous, intra-ar- terial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a con- tinuous or intermittent rate of infusion.
  • Page 12 • If a Medication Cassette Reservoir, CADD™ Extension Set or CADD™ Administration Set is used for medication delivery into the epidural or subarachnoid space, clearly differentiate them from those used for other routes of infusion, for example, by color cod- ing, or other means of identification.

  • Page 13: Symbols

    Section 1: General Description Symbols Direct Current (Power Jack) Accessory Jack Attention, see Instructions for Use 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 information) Date of Manufacture <...

  • Page 14: Pump Diagram

    Section 1: General Description Pump Diagram Dsplay Power Jack Accessory Jack Front AC Indcator View Lght Ar Detector Keypad ® Cassette Power Jack symbol Threaded Mountng Hole Accessory Jack symbol Rear Battery View Compartment Cassette Lock...

  • Page 15: Description Of The Keys, Display, And Features

    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.
  • Page 16 Cassette The cassette is the portion of the CADD™ 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: •...
  • Page 17 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 be- comes unlocked while the pump is running, delivery will stop and an alarm will occur.

  • Page 18: The Main Screen

    Section 1: General Description Downstream Occlusion Sensor: The pump contains a downstream oc- clusion 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.

  • Page 19: Lock Levels

    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 functions that are accessible in Lock Level 0 (LL0), Lock Level 1 (LL1), and Lock Level 2 (LL2).

  • Page 20: Lock Level Table

    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. LL0 permits complete access to all programming and operating functions. LL1 permits limited control of pump programming and operations.

  • Page 21: Pump Setup And Programming

    Section 2: Pump Setup and Programming Pump Setup and Programming Installing or Replacing the Batteries Use new, AA (IEC LR6) alkaline batteries such as DURACELL® or EVEREADY® ENERGIZER® batteries. The pump retains all programmed values while the batteries are removed. Some of the programmed values are retained in RAM memory that is supported by an internal battery for 5 years from date of manufacture.
  • Page 22 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.
  • Page 23 Section 2: Pump Setup and Programming 4. Place the battery door over the battery compartment and slide the door closed. 5. Ensure that the door is latched by trying to remove the door with- out 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 6 times at the end of the power-up sequence.
  • Page 24 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 bat- tery door becomes detached or loose, the batteries will not be properly secured;...
  • Page 25 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: • The life of the batteries is dependent on the amount of medication delivered, delivery rate, battery age, and the temperature.

  • Page 26: Watching Power Up

    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 programmed values. Watch for the following: • Pump model number and serial number appear unless an error has occurred, then the last error code (“LEC”) if any, will appear.

  • Page 27: Changing To Lock Level 0 (Ll0)

    Section 2: Pump Setup and Programming Changing to Lock Level 0 (LL0) Before programming the pump, make sure the pump is set to LL0. LL0 allows the clinician to access all programming and operating functions. 1. Make sure the pump is stopped. Press Œ...

  • Page 28: Programming The Pump: General Instructions

    Section 2: Pump Setup and Programming Programming the Pump: General Instructions The procedure for changing a programmed setting is similar for most programming screens. WARNING: Ensure that the ± 6% System Delivery Accuracy specifica- tion is taken into account when programming the pump and/or filling the Medication Cassette Reservoir.

  • Page 29: Delivery Methods

    The CADD-Legacy® PLUS pump has 2 delivery methods, and provides delivery in milliliters per hour: • Continuous Delivery Mode (up to 125 ml per hour) •...
  • Page 30 Section 2: Pump Setup and Programming 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 KVO feature allows you to deliver a minimal amount of medication between doses to maintain catheter patency.

  • Page 31: Programming Screens For Continuous Delivery

    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 100.0 Continuous Rate Continuous Rate (ml/hr) 5.0...
  • Page 32 Section 2: Pump Setup and Programming Continuous Rate Enter the continuous rate of medication delivery (in ml/hr). The maxi- mum rate is 125 ml/hr. Given This screen shows the total amount of medication delivered since the last time the value was cleared. The amount shown is rounded to the nearest 0.05 ml.

  • Page 33: Programming Continuous Delivery

    Section 2: Pump Setup and Programming Programming Continuous Delivery WARNING: This pump delivers medication at a continuous rate or intermittent rate in milliliters per hour (ml/hr). Programming the pump at a delivery rate other than what is prescribed will cause over or under delivery of medication, which could result in patient injury or death.
  • Page 34 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 serious injury or death to the patient. •...

  • Page 35: Programming Screens For Intermittent Delivery

    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 100.0 ml Dose Volume Dose Volume 0.0 Dose Duration...
  • Page 36 Section 2: Pump Setup and Programming Reservoir Volume Enter the volume of fluid contained in a filled fluid container. The Reser- voir 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.
  • Page 37 Section 2: Pump Setup and Programming KVO Rate The KVO or “Keep Vein Open” rate is optional. It allows the delivery of a medication to help maintain catheter patency. The programming 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.
  • Page 38 Section 2: Pump Setup and Programming 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).

  • Page 39: Programming Intermittent Delivery

    Section 2: Pump Setup and Programming Programming Intermittent Delivery WARNING: This pump delivers medication at a continuous rate or intermittent rate in milliliters per hour (ml/hr). Programming the pump at a delivery rate other than what is prescribed will cause over or under delivery of medication, which could result in patient injury or death.
  • Page 40 Section 2: Pump Setup and Programming 5. Enter the Dose Cycle. • Press ´ Î to select the desired cycle. • Press ¤ • Press „ 6. Enter the KVO rate. • Press ´ Î to select the desired KVO rate. ¤...
  • Page 41 Section 2: Pump Setup and Programming • Press „ 11. Verify the Upstream Sensor status. • Make sure the desired setting is displayed. This screen will show whether the Upstream Occlusion Sensor is turned on or off. WARNING: When the Upstream Occlusion Sensor is turned off, the pump will not detect occlusions upstream (between pump and fluid container).

  • Page 42: Removing A Cassette

    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.

  • Page 43: Attaching A Cassette

    Section 2: Pump Setup and Programming Attaching a Cassette Obtain a new, filled Medication Cassette Reservoir, or CADD™ Adminis- tration 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 prepar- ing the product for use.
  • Page 44 If you are using a CADD™ Administration Set or Medication Cassette Reservoir that does not have the flow stop feature (catalog number does not start with 21-73xx): You must use a CADD™...

  • Page 45: Priming The Tubing (Using The Pump) And Connecting To The Patient

    Section 2: Pump Setup and Programming Priming the Tubing (Using the Pump) and Connecting to the Patient The pump must be stopped and in LL0 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.
  • Page 46 Section 2: Pump Setup and Programming 6. 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 bub- bles before connecting to the patient to prevent air embolism.

  • Page 47: Inserting The Tubing Into The Air Detector

    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.
  • Page 48 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. Retenton nubs 4. Connect the tubing to the patient’s infusion set or indwelling catheter.

  • Page 49: Setting The Lock Level For The Patient

    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 operating functions. NOTE: You may change the lock level at any time by stopping the pump and following the procedure below.

  • Page 50: Cdm: Programming With Upper Limits, Adjusting Rate In Lock Level 1

    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.

  • Page 51: Idm: Stopping The Pump During The Dose

    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 subsequent doses by the amount of time the pump is stopped. Pump is stopped for subsequent 10 minutes doses shift by...
  • Page 52 Section 2: Pump Setup and Programming Stopping the pump during the KVO will not affect the start time of sub- sequent doses.

  • Page 53: Operating The Pump

    Section 3: Operating the Pump Operating the Pump Starting the Pump When you start the pump, programmed values will be automatically re- viewed. Then fluid delivery will begin as programmed, and “RUN” will ap- pear on the main screen. If the pump will not start, a message will appear on the display.

  • Page 54: Turning The Pump On/Off

    Section 3: Operating the Pump 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 disconnected 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.

  • Page 55: Biomed Functions

    Section 4: Biomed Functions Biomed Functions Overview: Accessing the Biomed Functions The Biomed Functions are pump configurations that are less frequently changed. The Biomed Functions are accessible only when the pump is stopped and in Lock Level 0. To Access the Biomed Functions 1.

  • Page 56: Air Detector On/Off

    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.

  • Page 57: Upstream Sensor On/Off

    Section 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.”...

  • Page 58: Changing The Delivery Method

    Section 4: Biomed Functions Changing the Delivery Method Delivery can be changed between Continuous Delivery and Intermit- tent Delivery. This allows for either continuous medication delivery or infusion of a prescribed volume of a medication over a specified time period. When the delivery method is changed, programming will revert to default settings.

  • Page 59: Reference

    Section 5: Reference Reference Messages and Alarms, Alphabetical List Messages and Alarms Description/Corrective Action Air In Line Detected The Air Detector has detected air in the fluid path; the fluid path may contain air Tone alarm bubbles, or the tubing may not be fully threaded through the Air Detector.
  • Page 60 Section 5: Reference Messages and Alarms Description/Corrective Action High Pressure The pump has detected high pressure, which may be resulting from a Tone alarm downstream blockage, kink in the fluid path, or a closed tubing clamp. Remove the obstruction to resume operation. „...
  • Page 61 No Disposable, You have tried to start the pump without Pump won’t run a disposable (CADD ™ Administration Set or Medication Cassette Reservoir) attached, Tone alarm or the disposable is attached but is not aligned with the pump or is damaged, or a malfunction of the pump sensor(s) is occurring.
  • Page 62 Section 5: Reference Messages and Alarms Description/Corrective Action Power lost while The pump was on and running when pump was on power was removed. Stop the pump before changing the battery or removing Tone alarm the power source. Press ⁄ „...

  • Page 63: Cleaning The Pump And Accessories

    Section 5: Reference Cleaning the Pump and Accessories CAUTION: • Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment. Moisture build-up inside the pump may damage the pump.
  • Page 64 Section 5: Reference Cleaning the Battery Contacts Routinely clean the battery contacts, possibly as part of the preventa- tive maintenance cycle, to remove buildup of foreign material on the contacts. Use the following to clean the battery contacts: • Cotton swab wetted with Isopropyl Alcohol (70% minimum) NOTE: Do not use an alcohol formulation that contains components other than alcohol and water.

  • Page 65: Exposure To Radiation, Ultrasound, Magnetic Resonance Imaging (Mri), Or Use Near Ecg Equipment

    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 radia- tion 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.

  • Page 66: Technical Description

    Section 5: Reference Technical Description Standards used in Development of the Pump The following standards were used in whole or part in the development of the pump. Medical Electrical Equipment EN 60601-1 (1990), Medical Electrical Equipment, Part 1: General Re- quirements for Safety.

  • Page 67: Specifications (Nominal)

    Amendment 1 (1999) Amendment 2 (2002). Specifications (Nominal) General Pump Specifications CADD ™ Medication Cassette Reservoir P/N 21-7002 and CADD ™ Extension Set P/N 21-7045 were used to test the pump. Resolution ......Medication Cassette Reservoir or CADD™ Admin- istration Set, 0.050 ml per pump stroke nominal...
  • Page 68 Section 5: Reference Pump Alarms .....Low battery power; depleted battery power; bat- tery dislodged; pump stopped; pump fault; low reservoir volume; high delivery pressure; air in line; disposable not attached when run attempt- ed; motor locked; upstream occlusion; reservoir volume empty; program incomplete; key stuck; disposable detached.
  • Page 69 System Definition ....System is defined as a CADD-Legacy® pump with an attached Medication Cassette Reservoir and CADD™ Extension Set with integral anti- siphon valve, or an attached CADD™...
  • Page 70 Section 5: Reference Continuous Delivery Mode Specifications Reservoir Volume ....1 to 9999 or Not In Use; programmable in 1 ml increments, displayed in 0.1 ml increments Default: 1.0 ml Continuous Rate ....0.1 to 125 ml/hr; programmable in 0.1 ml /hr increments Default: 0.0 ml Given ........0 to 99999.95 in 0.05 ml increments...
  • Page 71 Section 5: Reference Biomed Functions Air Detector .......Off On-Low On-High Default: On-High Upstream Sensor ....Off Default: On Delivery Mode ....Continuous Intermittent Default: Intermittent...

  • Page 72: Accuracy Test Results

    Section 5: Reference Accuracy Test Results The following graphs are designed to show flow accuracy of the infusion system plotted against given time periods. Flow rate: Intermediate Time Interval: 0.5 min Total Time: 120 min Programmed Rate: 24.0 ml/hr Flow Flow (ml/hr) (ml/hr)
  • Page 73 Section 5: Reference Flow rate: Minimum Time Interval: 15 min Total Time: 1500 min Programmed Rate: 0.1 ml/hr Flow (ml/hr) T (hr) Trumpet curve: Minimum rate Programmed Rate: 0.1 ml/hr Average Flow Rate: 0.0989 ml/hr Mean Flow Error: -1.05 % % Error of Flow T (min)

  • Page 74: Electromagnetic Emissions And Immunity Declarations

    Section 5: Reference Electromagnetic Emissions and Immunity Declarations Electromagnetic emissions declaration The Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump should assure that it is used in such an environment. Emssons test Complance Electromagnetc envronment –...
  • Page 75 Section 5: Reference WARNING: The Pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the user should verify normal operation of the pump in the configura- tion in which it is to be used. Electromagnetic immunity declaration The Pump is intended for use in the electromagnetic environment specified below.
  • Page 76 Section 5: Reference Electromagnetic immunity declaration The Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump should assure that it is used in such an environment. Immunty test IEC 00 Complance Electromagnetc envronment –...
  • Page 77 Section 5: Reference Recommended separation distances between portable and mobile RF communications equipment and the Pump The Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pump can help prevent electro- magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pump as recommended below, accord- ing to the maximum output power of the communications equipment.

  • Page 78: Safety Features And Fault Detection

    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.
  • Page 79 Section 5: Reference the motor drive circuit without running the motor. The microprocessor performs this test function every several minutes to assure its continued functionality. An input from the watchdog circuit prevents motor opera- tion if the watchdog timer expires. The software verifies this function during the watchdog test described above.

  • Page 80: Software Safety Features

    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 medication delivery.

  • Page 81: Data Handling Software Safety Features

    Section 5: Reference 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 medication delivery.

  • Page 82: Annual Functional Inspection And Testing Procedures

    Annual Functional Inspection and Testing Procedures Smiths Medical MD, Inc. 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 accuracy. The pump must be in Lock Level 0 (LL0) to perform the follow- ing inspections and tests.

  • Page 83: Testing Procedures

    • Attach either a 50 or 100 ml Medication Cassette Reservoir 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.
  • Page 84 Motor and Gear Train Check • Program the Reservoir Volume to 2.0 ml. • Attach a 50 or 100 ml Medication Cassette Reservoir or CADD™ Ad- ministration Set to the pump. Lock the cassette. • ‹ Press and hold until 3 series of dashes appear.
  • Page 85 Section 5: Reference • Press and hold ‹ until 3 series of dashes appear. Release ‹ Press and hold . The pump should prime 10 double activations ‹ and then stop. The pump will alarm and display “Reservoir Volume Empty.” Press „...
  • Page 86 Î is displayed. Then press ¤ • Attach an empty 50 or 100 ml Medication Cassette Reservoir or CADD™ Administration Set to the pump. Secure it using the lock button. • Thread the tubing through the Air Detector groove. •...
  • Page 87 Verify the Upstream Occlusion Sensor is turned On (see Section 4, Biomed Functions). • Obtain a CADD™ Administration Set with bag spike. Also obtain a clamp (slide clamp or hemostat). • Insert the CADD™ Administration Set spike into an appropriate, standard IV bag filled with water.

  • Page 88: Occlusion Pressure Range Tests

    Section 5: Reference Occlusion Pressure Range Tests Occlusion Pressure Range Test I 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...
  • Page 89 0 PSI [2.76 bar] Regulator Pressure Gauge 4. Connect the Medication Cassette Reservoir outlet tube to the me- tered pressure source. NOTE: Do not use a CADD™ Extension Set with Anti-Siphon Valve. 5. Start the pump and run at 50 ml/hr.
  • Page 90 Section 5: Reference 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.

  • Page 91: Accuracy Tests

    Medication Cassette Reservoir. 2. Remove any air from the Medication Cassette Reservoir by aspi- rating the air with the syringe. Attach the CADD™ Extension Set. Prime the tubing so it is filled with fluid to the end of the extension...
  • Page 92 Section 5: Reference 3. Secure the slide clamp as close to the extension set Luer lock con- nector as possible. This should assure a minimum water loss from the tubing when the syringe is removed. 4. Weigh the entire Medication Cassette Reservoir/extension set and record the weight.
  • Page 93 Section 5: Reference Example: Predelivery Weight: 61.1 g Postdelivery Weight: – 41.6 g 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: ÷...
  • Page 94 Medication Cassette Reservoir. 2. Remove any air from the Medication Cassette Reservoir by aspi- rating the air with the syringe. Attach the CADD™ Extension Set. Prime the tubing so it is filled with fluid to the end of the extension set Luer.
  • Page 95 Section 5: Reference 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 delivered. This is the actual delivery volume. 7. Find the difference between the volume of the amount delivered and the intended delivery volume.

  • Page 96: Index

    Section 5: Reference Index cassette, 4, 6 attaching, 33 Bold page numbers indicate figure caution, vi references. removing, 32 warnings, iv-vi cassette lock, 4, 7, 33 cleaning pump, accessories, 53 accessory jack, 3, 4 cautions, vii accuracy tests, 62-63 Continuous Delivery Mode, 19 gravimetric, 81 Continuous Rate, 10, 22, 40, 60 volumetric, 84...
  • Page 97 Section 5: Reference attaching, 33 removing, 32 indicator light, 4 Reservoir Volume, 8, 10, 21, 23, 26, 29, inspection procedures, 72-73 35, 52, 58, 60 Intermittent Delivery Mode, 20 resetting, 44 keypad, keys, 4, 5 safety features KVO rate, 20, 27, 60 hardware, 68-69 software, 70-71 security codes...

  • Page 98: Limited Warranty

    Section 5: Reference Limited Warranty Smiths Medical MD, 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 workmanship 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.
  • Page 99 Section 5: Reference E. Computer Program License: 1. The Pump is intended to be used in conjunction with a particular Licensed Computer Program supplied by Manufacturer and use of any other program or unauthorized modification of a Licensed Computer Program shall void Manufacturer’s warranty as set forth above. 2.
  • Page 100 CADD, CADD-Legacy, the Medcaton Cassette Reservor desgn mark, and the Smths desgn mark ® are trademarks of the Smths Medcal famly of companes. The symbol ndcates the trademark s regstered n the U.S. Patent and Trademark Office and certan other countres.

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