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CADD Legacy Duodopa 1400 Operator's Manual

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Legacy
Duodopa
Operator's Manual
CADD-Legacy
Duodopa
®
®
Pump Model 1400
This Operator's Manual is for clinician use only.
Read the entire Operator's Manual before
operating the pump.

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Summary of Contents for CADD Legacy Duodopa 1400

  • Page 1 Legacy Duodopa Operator’s Manual CADD-Legacy Duodopa ® ® Pump Model 1400 This Operator’s Manual is for clinician use only. Read the entire Operator’s Manual before operating the pump.

  • Page 2: Technical Assistance

    ® 1400. There are other CADD-Legacy pump models available; review the ® ® rear label of the pump to ensure it is a CADD-Legacy Duodopa pump, Model 1400, before programming. The pump is designed for enteral ® delivery of Duodopa and can be programmed to deliver a Continuous Rate, a Morning Dose, and Extra Doses.

  • Page 3: Warnings

    ® Read this entire Operator’s Manual before operating the CADD-Legacy ® Duodopa pump. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient, and/or damage to the pump. Warnings • This Operator’s Manual should be used by clinicians only. Do not...
  • Page 4 Do not prime the fluid path with the tubing connected to a patient as ® this could result in over-delivery of Duodopa ® ® • System delivery accuracy of the CADD-Legacy Duodopa pump and ® attached Duodopa reservoir is ± 10%. System delivery inaccuracies...

  • Page 5: Cautions

    Cautions • Use only Smiths Medical accessories and replacement parts, as using other brands may adversely affect the operation of the pump. • Do not operate the pump at temperatures below 2°C (36°F) or above 40°C (104°F). • Do not store the pump at temperatures below -20°C (-4°F) or above ®...
  • Page 6 ® ® warranties. All service and repair of CADD-Legacy Duodopa pumps must be performed by Smiths Medical or its authorized agents.

  • Page 7: Table Of Contents

    Contents Warnings Cautions 1.0 General Description Introduction ......................1 Indications ......................1 Symbols ........................2 Pump Diagram ....................3 Description of the Keys, Display, and Features ..........4 The Main Screen ....................7 Lock Levels ......................8 Security Codes ....................8 Lock Level Table ....................9 2.0 Pump Setup and Programming Installing or Replacing the Batteries .............11 Watching Power Up ..................16 Changing to Lock Level 0 (LL0) ..............17...
  • Page 8 3.0 Operating the Pump Starting the Pump ....................31 Stopping the Pump ..................31 Turning the Pump On/Off ................32 Starting a Morning Dose.................33 Starting an Extra Dose ................... 34 Stopping an Extra Dose or Morning Dose ..........34 Resetting the Reservoir Volume ..............35 4.0 Biomed Functions Overview: Accessing the Biomed Functions and Programming the Lockouts .............37...

  • Page 9: Section 1: General Description

    Abbott. The Duodopa reservoir attaches to the bottom of the pump. ® ® ® WARNING: The CADD-Legacy Duodopa pump and Duodopa reservoir (supplied by Abbott) are designed for enteral delivery of ® Duodopa only. They are NOT intended for IV or other parenteral routes of infusion.

  • Page 10: Symbols

    Section 1: General Description Symbols Direct Current (Power Jack) Accessory Jack Caution 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 11: Pump Diagram

    Section 1: General Description Pump Diagram Display Power Jack Accessory Jack AC Indicator Light Front Not used in this application View (Do not place tubing in slot) Keypad ® Duodopa Reservoir Power Jack symbol Accessory Jack symbol Rear View Battery Compartment Cassette Latch...

  • Page 12: 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 the pump. Display The Liquid Crystal Display (LCD) shows programming information and messages.

  • Page 13: Battery Compartment

    See the Instructions for Use supplied with those accessories. ® Duodopa Reservoir ® The single-use reservoir is designed for use with the CADD-Legacy ® Duodopa pump. In this manual and on the pump’s display, the word ® “disposable” refers to the Duodopa reservoir.
  • Page 14 Section 1: General Description 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 occlusion in the reservoir is detected, an alarm will sound, delivery will stop, and the display will show “Upstream Occlusion.”...

  • Page 15: The Main Screen

    Section 1: General Description The Main Screen The Main Screen is the starting point for programming or viewing the pump’s settings. If no keys are pressed for 2 minutes, the display reverts to the Main Screen. When the two AA batteries are low, “LowBat” appears on the Main Screen.

  • Page 16: 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 17: 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 or running. LL0 permits complete access to all programming and operating functions. LL1 permits limited control of pump programming and operations.
  • Page 18 Section 1: General Description...

  • Page 19: Section 2: Pump Setup And Programming

    Section 2: Pump Setup and Programming Pump Setup and Programming Installing or Replacing the Batteries ® ® Use new, AA alkaline batteries such as DURACELL or EVEREADY ® ENERGIZER batteries to power the pump. The pump retains all programmed values while the batteries are removed. Dispose of used batteries in an environmentally safe manner, and according to any regulations which may apply.
  • Page 20 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 21 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 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 6 times at the end of the power- up sequence.
  • Page 22 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;...
  • Page 23 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 Duodopa delivered, delivery rate, battery age, and the temperature.

  • Page 24: 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 last error code (“LEC”) if any, will appear. (If an error code appears, the pump should be removed from use and returned for service.) •...

  • Page 25: 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. Π1. Make sure the pump is stopped. Press .

  • Page 26: 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. • Make sure the pump is stopped and in Lock Level 0. • „ To begin programming, start at the Main Screen and press •...

  • Page 27: Delivery Methods

    Section 2: Pump Setup and Programming Delivery Methods ® ® The CADD-Legacy Duodopa pump offers 3 methods of delivery: • Continuous Rate • Extra Dose • Morning Dose The following graph illustrates the combined delivery methods. The Continuous Rate, Extra Dose, and Morning Dose are programmed as described in this section.

  • Page 28: Programming Screens

    Section 2: Pump Setup and Programming Programming Screens ® ® These are the programming screens for the CADD-Legacy Duodopa pump. Descriptions of the screens follow. Reservoir Volume (ml) Reservoir Volume 100.0 Continuous Rate (ml/hr) Continuous Rate ml/hr Extra Dose (ml)
  • Page 29 Section 2: Pump Setup and Programming Continuous Rate ® Enter the continuous rate of Duodopa delivery in ml/hr. The maximum rate is 20 ml/hr. If the prescription does not call for a Continuous Rate, enter zero. NOTE: If you intend to run the pump in Lock Level 1 so the Continuous Rate can be varied, you should enter the maximum allowable rate while programming in Lock Level 0. After programming, you may then change to Lock Level 1 and decrease the rate to its starting value. See Programming with Upper Limits, Adjusting Doses in LL1 at the end of Section 2.

  • Page 30: Programming Delivery

    Section 2: Pump Setup and Programming Programming Delivery WARNING: Programming the pump at a delivery rate other than ® what is prescribed will cause over- or under-delivery of Duodopa which could compromise patient treatment. To program the pump, enter the prescribed values. 1.

  • Page 31: Programming A Morning Dose

    Section 2: Pump Setup and Programming • Press „ 6. Review the program. Press repeatedly to review the programming screens. If you „ need to reprogram a setting, press until the appropriate „ screen appears and change the setting as described in this section. Programming a Morning Dose The pump must be running and a reservoir must be attached in order to program a Morning Dose.

  • Page 32: Removing A Duodopa® Reservoir

    Section 2: Pump Setup and Programming Removing a Duodopa® Reservoir WARNING: Clamp the fluid path tubing and/or disconnect the ® tubing from the enteral access device before removing the Duodopa reservoir from the pump to prevent uncontrolled delivery of ® Duodopa , which could compromise patient treatment.

  • Page 33: Attaching A Duodopa® Reservoir

    Section 2: Pump Setup and Programming Attaching a Duodopa® Reservoir ® Obtain a new, filled Duodopa reservoir. WARNING: ® • Use only Duodopa reservoirs supplied by Abbott to maintain pump accuracy and assure proper pump operations. • Use only extension sets specified by Abbott, paying particular attention to all warnings and cautions associated with their use. DO NOT use extension sets with anti-siphon valves.
  • Page 34 Section 2: Pump Setup and Programming 2001-01-15 D. Zurn 4. Insert a coin into the slot in the «Lgc Lock Coin Large Cass» Cassette Latch, push in, and turn counterclockwise until the line on the latch lines up with the arrow on the side of the pump and you feel the latch click into place.

  • Page 35: Priming The Tubing And Connecting To The Patient

    Section 2: Pump Setup and Programming Priming the Tubing and Connecting to the Patient WARNING: Do not prime the fluid path with the tubing connected ® to a patient as this could result in over-delivery of Duodopa , which could compromise patient treatment. The pump must be stopped and in LL0 or LL1 in order to prime the fluid path.

  • Page 36: 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 37: Programming With Upper Limits, Adjusting Doses In Lock Level 1

    Section 2: Pump Setup and Programming Programming with Upper Limits, Adjusting Doses in Lock Level 1 If a prescription allows for the Continuous Rate, Extra Dose, or Morning Dose to be adjusted during the course of therapy, you may wish to operate the pump in LL1.
  • Page 38 Section 2: Pump Setup and Programming...

  • Page 39: Section 3: Operating The Pump

    Section 3: Operating the Pump Operating the Pump Starting the Pump When you start the pump, programmed values will be automatically ® reviewed. Then Duodopa delivery will begin as programmed, and “RUN” will appear on the Main Screen. If the pump will not start, a message will appear on the display.

  • Page 40: 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 41: Starting A Morning Dose

    Section 3: Operating the Pump Starting a Morning Dose A Morning Dose may be delivered in any Lock Level while the pump is ® running. It allows you to deliver a specified amount of Duodopa , as a loading dose for example. If the patient attempts to deliver a Morning Dose during the lockout time, the pump will not deliver the dose.

  • Page 42: Starting An Extra Dose

    Section 3: Operating the Pump Starting an Extra Dose If an Extra Dose has been programmed, the patient may start an Extra Dose while the pump is running. The amount delivered is added to the amount provided by the Continuous Rate. If the patient attempts to deliver an Extra Dose during the lockout time, the pump will not deliver the dose.

  • Page 43: Resetting The Reservoir Volume

    Section 3: Operating the Pump Resetting the Reservoir Volume To reset the Reservoir Volume to the value programmed in LL0, the pump may be in any Lock Level. 1. Stop the pump. 2. Press „ to display the Reservoir Volume screen. 3.
  • Page 44 Section 3: Operating the Pump...

  • Page 45: Section 4: Biomed Functions

    Section 4: Biomed Functions Biomed Functions Overview: Accessing the Biomed Functions and Programming the Lockouts 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 46: Extra Dose Lockout

    Section 4: Biomed Functions Extra Dose Lockout The Extra Dose Lockout time determines how often a patient can receive ® an Extra Dose of Duodopa . The lockout time is the minimum amount of time that must elapse between the start of one dose and the start of the next.

  • Page 47: Morning Dose Lockout

    Section 4: Biomed Functions Morning Dose Lockout The Morning Dose Lockout time determines how often a patient can receive a Morning Dose. The lockout time is the minimum amount of time that must elapse between the start of one dose and the start of the next.

  • Page 48: Upstream Occlusion Sensor On/Off

    Section 4: Biomed Functions Upstream Occlusion Sensor On/Off The Upstream Occlusion Sensor can be set to On or Off. If this screen is set to On, and an occlusion in the reservoir is detected, an alarm will sound, delivery will stop, and the display will show “Upstream Occlusion.”...

  • Page 49: Section 5: Reference

    Section 5: Reference Reference Messages and Alarms, Alphabetical List Messages and Alarms Description / Corrective Action [No message] With no AC adapter attached, the batteries have been removed while the pump is running. Two-tone alarm The pump is now stopped and unpowered. Install batteries to silence the alarm.
  • Page 50 Section 5: Reference Messages and Alarms Description / Corrective Action Error An error has occurred. Remove the pump from use and contact Smiths Medical to Two-tone alarm return the pump for service. High Pressure The pump has detected high pressure, which may be resulting from a downstream Two-tone alarm blockage, kink in the fluid path, or a closed...
  • Page 51 Section 5: Reference Messages and Alarms Description / Corrective Action Power lost while The pump was running when power was pump was on removed. Stop the pump before changing the batteries or removing the power source. Press Two-tone alarm ⁄ „...

  • Page 52: 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 buildup inside the pump may damage the pump. • Do not 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.

  • Page 53: Cleaning The Battery Contacts

    Section 5: Reference Cleaning the Battery Contacts Routinely clean the battery contacts, possibly as part of the preventative 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 54: Exposure To Radiation, Magnetic Resonance Imaging (Mri) Or Use Near Ecg Equipment

    Section 5: Reference Exposure to Radiation, Magnetic Resonance Imaging (MRI) or Use near ECG Equipment CAUTION: • Do not expose the pump to ther a peutic levels of ionizing radiation as permanent damage to the pump’s electronic circuitry may occur. The best procedure to fol low is to remove the pump from the patient during therapeutic radia tion sessions.

  • Page 55: Continuous Rate Scroll Ranges

    Section 5: Reference Continuous Rate Scroll Ranges Starting Value Increment Maximum 0.0 ml/hr 0.1 ml/hr 20.0 ml/hr Extra Dose, Morning Dose Scroll Ranges Extra Dose Increment max. 0.1 ml 9.9 ml Morning Dose Increment max. 0.1 ml 20 ml...

  • Page 56: 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 Requirements for Safety. Amendment A1 (1993) Amendment A13 (1996) Amendment A2 (1995).

  • Page 57: Specifications (Nominal)

    Section 5: Reference RTCA/DO -160C, Radiated Emissions Only, Category A & Z Limit. CISPR11 (1990), Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment. Amendment 1 (1996) Amendment 2 (1996). CISPR14, Radiated and Conducted Emissions, device powered by AC adapter only.
  • Page 58 Section 5: Reference Maximum Time to Occlusion Alarm ....7.0 hours. Bolus Volume at Occlu sion Alarm Pressure ........<1.1 ml Power Sources ......Two AA alkaline batteries; AC Adapter The expected life of 2 AA batteries is 100 hours at 100 ml/16 hours, or approximately 14 days at 10 ml/day (nominal).
  • Page 59 Failure to carefully consider this may compromise patient treatment. ® System Definition ....System is defined as a CADD-Legacy ® Duodopa pump with an attached ®...

  • Page 60: Delivery Specifications

    Section 5: Reference Delivery Specifications Reservoir Volume ....... 1 to 9999 ml or Not In Use; programmable in 1 ml increments, displayed in 0.1 ml increments Default: Not In Use Continuous Rate ....0 to 20 ml/hr in 0.1 ml/hr increments Default: 0.1 ml/hr Extra Dose ......0 to 9.9 ml in 0.1 ml increments Delivery rate (Continuous Rate + Extra...

  • Page 61: 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. The reservoir used for flow accuracy tests was supplied by Abbott. Flow rate immediately following startup Time Interval: 0.5 min Total Time:...
  • Page 62 Section 5: Reference Flow rate immediately following startup Time Interval: 15 min Total Time: 1545 min Programmed Rate: 0.1 ml/hr ® Reservoir Used: Duodopa reservoir 0.20 0.15 Flow 0.10 (ml/hr) 0.05 0.00 T (hr) Short term flow rate error Programmed Rate: 0.1 ml/hr Average Flow Rate: 0.1008 ml/hr...

  • Page 63: 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. Emissions test Compliance Electromagnetic environment –...
  • Page 64 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 configuration in which it is to be used. 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.
  • Page 65 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. Immunity test IEC 60601 Compliance Electromagnetic environment –...
  • Page 66 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 electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pump as recommended below, according to the maximum output power of the communications equipment.

  • Page 67: 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 68: Voltage Detector Circuit

    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 operation if the watchdog timer expires. The software verifies this function during the watchdog test described above.

  • Page 69: 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 70: 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 71: Annual Functional Inspection And Testing Procedures

    ® any and all warranties. All service and repair of CADD-Legacy ® Duodopa pumps must be performed by Smiths Medical or its authorized agents.

  • Page 72: Index

    Section 5: Reference Index attaching, 25-26 removing, 24 Bold page numbers indicate figure references ECG equipment, interference with, Accessory Jack, 3 Electromagnetic emissions and accuracy, 50 immunity declarations, 55-58 accuracy tests, 53 Extra Dose, 19 AC Adapter, 5 programming, 9 AC indicator light, 3 starting, 9 arrow keys, 4...
  • Page 73 Section 5: Reference power-up, 16 Power Jack, 3 priming, 9 programming, 22 programming, general, 18 programming screens, 20 radiation, exposure to, 46 Remote Dose Cord, 5 Reservoir Volume, 6 programming, 22 resetting, 9 safety features hardware, 59 software, 61 security codes Biomed Functions Code, 8 Lock Level Code, 8 service due, 43...

  • Page 74: Limited Warranty

    Section 5: Reference Limited Warranty Smiths Medical ASD, 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 75 Section 5: Reference 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 Manufacturer or its agents are believed to be accurate and reliable, but do not constitute warranties.
  • Page 78 CADD, CADD-Legacy, and the Smiths Medical design mark are trademarks of Smiths ® Medical. The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.

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