CADD-Legacy 1400 Operators Manual Rev C Jan 2015

This manual pertains only to the CADD-Legacy® 1400 pump. There are other CADD-Legacy® pump models available; review the rear label of the pump to ensure it is a CADD-Legacy® 1400 pump before programming. This pump is designed for enteral delivery of medication and can be programmed to deliver a continuous rate, a morning dose, and extra doses. This manual is intended for clinician use only. Do not permit patients to have access to this manual. The pump has 3 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 Smiths Medical 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® 1400 pump, please call the number given below. When calling, please specify the pump’s software revision. This information is located on the pump’s display during power up. Our staff at Smiths Medical is available to help clinicians 24 hours a day with the programming and operation of the CADD-Legacy® 1400 pump. Smiths Medical ASD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 USA Tel: 1 800 258 5361 (USA) Tel: +1 614 210 7300 www.smiths-medical.com

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Read this entire operator’s manual before operating the CADD‑Legacy® 1400 pump. Failure to follow the warnings and cautions below could result in return of symptoms, damage to the pump, serious injury, or death in extreme cases. Please refer to the full prescribing information for DUOPA (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions.

Warnings • This operator’s manual should be used by clinicians only. Do not permit patients to have access to this manual, as the information contained would allow the patient complete access to all programming and operating functions. Improper programming could compromise patient treatment. • To avoid explosion hazard, do not use the pump in the presence of flammable anesthetics or explosive gases. • The CADD-Legacy® 1400 pump and medication cassette reservoir are designed for enteral delivery of medication only. They are NOT intended for IV or other parenteral routes of infusion. • 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. Improper programming could compromise patient treatment. • Always have new batteries available for replacement. If power is lost, non-delivery of medication will occur. • 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 and non-delivery of medication. • 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 and non-delivery of medication.

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• System delivery inaccuracies beyond the stated accuracy may occur as a result of back pressure or fluid resistance, which depends upon temperature, medication viscosity, catheter size, extension set tubing, flow rate, and orientation of the pump system. • Programming the pump at a delivery rate other than what is prescribed will cause over- or under-delivery of medication. • Clamp the fluid path tubing and/or disconnect the tubing from the enteral access device before removing the medication cassette reservoir from the pump to prevent unintended delivery of medication. • Use only approved DUOPA medication cassette reservoirs to maintain pump accuracy and assure proper pump operations. • Use only extension sets approved for use with DUOPA, paying particular attention to all warnings and cautions associated with their use. • Attach the cassette properly. The cassette is the part of the medication cassette reservoir that attaches to the pump. A detached or improperly attached cassette could result in unintended delivery of medication. • Do not prime the fluid path with the tubing connected to a patient as this could result in over-delivery of medication. • 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, as this could compromise patient treatment. • The use of power supplies and a remote dose cord other than those listed in the electromagnetic emissions declaration may result in increased emissions or decreased immunity of the pump. • 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. • There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply.

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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 60°C (140°F). Do not store the pump with the medication cassette reservoir attached. Use the protective cassette provided. • Do not expose the pump to humidity levels below 20% or above 90% relative humidity. • Do not sterilize the pump or medication cassette reservoir as this could cause damage. • When the upstream occlusion sensor is turned off, the pump will not detect occlusions in the medication cassette reservoir. Periodically inspect the medication cassette reservoir for decreasing volume. Undetected occlusions could result in under- or non-delivery of medication. • Do not use rechargeable NiCd 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 properly. • Do not store the pump for prolonged periods of time with the batteries installed. Battery leakage could damage the pump. • Prior to starting medication delivery, inspect the fluid path for kinks, a closed clamp, or other obstruction. An undetected occlusion may result in under- or non-delivery of medication and/or nuisance alarms. • When you enter a new value, any lockout time already in effect will be cleared. An extra dose or morning dose could be requested and delivered immediately upon starting the pump, which may result in over-delivery of medication. • 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. vi

• Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners, as damage to the pump may occur. • Do not expose the pump to ther­apeutic levels of ionizing radiation as permanent damage to the pump’s electronic circuitry may occur. The best procedure to fol­low is to remove the pump from the patient during therapeutic radia­tion sessions. If the pump must remain in the vicinity during a ther­apy session, it should be shielded, and its ability to function properly should be confirmed following treatment. • Do not expose the pump directly to ultrasound, as permanent damage to the 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. • This pump may interfere with ECG equipment. Monitor ECG equipment carefully when using this pump. • CADD-Legacy® 1400 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® 1400 pumps must be performed by Smiths Medical or its authorized agents. • Review programming screens when complete to make sure desired programming has been entered. Check to make sure unintended changes were not made to the morning dose, continuous rate, or extra dose volume. If unintended changes were made, go to the appropriate screen and program the desired value.

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viii

Table of Contents Warnings

iv

Cautions

vi

1.0 General Description

1

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 0 (LL0) Table...9 Lock Levels 1 and 2 (LL1, LL2) Table...10

2.0 Pump Setup and Programming

11

Installing or Replacing the Batteries...11 Watching Power Up...16 Changing to Lock Level 0 (LL0) ...17 Programming the Pump: General Instructions...18 Delivery Methods...19 Programming Screens... 20 Programming Delivery...22 Programming a Morning Dose...23 Removing a Medication Cassette Reservoir...24 Attaching a Medication Cassette Reservoir...25 Priming the Tubing and Connecting to the Patient...27 Setting the Lock Level for the Patient... 28 Programming with Upper Limits, Adjusting Doses in Lock Level 1...29

3.0 Operating the Pump

31

Starting the Pump...31 Stopping the Pump...31 ix

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

37

Overview: Accessing the Biomed Functions and Programming the Lockouts...37 Extra Dose Lockout...38 Morning Dose Lockout...39 Upstream Occlusion Sensor On/Off... 40

5.0 Reference

41

Messages and Alarms, Alphabetical List...41 What if the pump is dropped or hit?... 44 Cleaning the Pump and Accessories...45 Exposure to Radiation, Ultrasound, Magnetic Resonance Imaging (MRI), or Use near ECG Equipment...47 Continuous Rate Scroll Ranges... 48 Extra Dose, Morning Dose Scroll Ranges... 48 Technical Description...49 Specifications (Nominal)...50 Accuracy Test Results... 54 Electromagnetic Emissions and Immunity Declarations... 56 Safety Features and Fault Detection... 60 Software Safety Features...62 Data Handling Software Safety Features...63 Annual Functional Inspection... 64 Collect Separately ... 64 Limited Warranty...65 Index...67

Appendix A – Pump Programming Quick Reference for Healthcare Providers

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71

Section 1: General Description

1.0

General Description

Introduction General Description

The CADD‑Legacy® 1400 pump provides enteral delivery of medication 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.

Indications The CADD-Legacy® 1400 pump is indicated solely for the enteral delivery of medication contained in a medication cassette reservoir supplied by AbbVie. The medication cassette reservoir attaches to the bottom of the pump. WARNING: The CADD-Legacy® 1400 pump and medication cassette reservoir are designed for enteral delivery of medication only. They are NOT intended for IV or other parenteral routes of infusion. Use of this product for medications or therapies outside the intended use can result in death or serious patient injury. Refer to AbbVie’s full prescribing information for DUOPA (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions.

1

Section 1: General Description

Symbols Direct current (power jack)

General Description

O

f K

Caution Class II equipment

J

Type CF equipment

E

Splashproof – water splashed against the pump housing will have no harmful effects (see Cleaning the Pump and Accessories, Section 5, for additional important information).

< > J H

Catalog number Serial number Date of manufacture Manufacturer

6

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Z

Collect separately

P _ i 

2

Accessory jack

Temperature limitation Humidity limitation Atmospheric pressure limitation MR Unsafe

Section 1: General Description

Pump Diagram Front View Display

General Description

Power Jack Accessory Jack AC Indicator Light Not used in this application (Do not place tubing in slot)

Keypad Medication Cassette Reservoir Power Jack symbol

Rear View

Accessory Jack symbol

Battery Compartment

Cassette Latch

3

Section 1: General Description

Description of the Keys, Display, and Features

General Description

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. In this manual, the term “display” is synonymous with display panel or LCD.

Keypad The keys on the keypad are described below. A key beeps when pressed if it is operable in the current lock level.

⁄ used to start and stop pump delivery; silences alarms. used to enter (save) a new value in the pump’s memory when ¤ programming doses or pump settings or to clear values from

record-keeping screens. It is also used to return from the biomed functions to the main screen (see Section 4).

‹ used to fill the tubing with medication. used to confirm and deliver the morning dose (typically used as a Œ daily loading dose) when the pump is running. When the pump is

stopped, it 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.)

used to move from one programming screen to the next without „ changing the setting or value displayed; silences alarms. used to “scroll up” or increase a value, or scroll through biomed ´ function settings. used to “scroll down” or decrease a value, or scroll through Î biomed function settings.

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Section 1: General Description

used to put the pump into a low power state when not in use or Å back into full power.

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 The accessory jack is used for attaching accessory cables. See the instructions for use supplied with those accessories.

Medication Cassette Reservoir The medication cassette reservoir is the single-use reservoir designed for use with the CADD-Legacy® 1400 pump. In this manual and on the pump’s display, the word “disposable” refers to the medication cassette reservoir. In AbbVie’s patient instructions for use, medication cassette reservoir is referred to as DUOPA cassette.

Battery Compartment Two AA batteries fit into the battery compartment. The AA batteries serve as the primary source of power, or as backup power when an AC adapter is in use.

Cassette Latch The cassette latch attaches the cassette to the pump. The term “cassette” refers to the part of the medication cassette reservoir that attaches to the bottom of the pump. If the cassette becomes unlatched while the pump is running, delivery will stop and an alarm will occur. If the cassette becomes unlatched while the pump is stopped, an alarm will occur.

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General Description

used by the patient to deliver a programmed amount of Í medication upon request (extra dose).

Section 1: General Description

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. CAUTION: When the upstream occlusion sensor is turned off, the pump will not detect occlusions in the medication cassette reservoir. Periodically inspect the medication cassette reservoir for decreasing volume. Undetected occlusions could result in under- or non-delivery of medication. Downstream Occlusion Sensor: The pump contains a downstream occlusion sensor. When a downstream occlusion (between the pump and the patient) 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 volume of medication in the medication cassette reservoir is low or depleted. Each time you change the medication cassette reservoir, you may reset the reservoir volume to the originally programmed value. Then, as medication is delivered, the reservoir volume automatically decreases. When the pump calculates that 5 ml remain in the medication cassette reservoir, 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. NOTE: The default setting for Reservoir Volume is Not in Use. The reservoir volume alarm is activated only when a value is programmed into the Reservoir Volume screen. Programming a reservoir volume value is not required for general use, but is available at provider discretion.

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Section 1: General Description

The Main Screen The main screen is the starting point for programming or viewing the pump’s settings.

Battery Status

When running: Status of pump Reservoir Volume*

RUN ResVol

LowBat nn.n ml

Status of Reservoir Volume

*Does not appear on the main screen if reservoir volume is programmed to Not In Use. When stopped: Status of pump

STOPPED

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General Description

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.

Section 1: General Description

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). 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.

Security Codes The following security codes are preset by the manufacturer for the clinician’s use:

**Text Omitted**

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 operating functions. Improper programming could compromise patient treatment.

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Section 1: General Description

Lock Level 0 (LL0) Table

Pump Operations and Programming

Stopped

Running

LL0

Any Lock Level

Stop/Start the pump

Yes

Yes

Reset reservoir volume

Yes

No

Prime

Yes

No

Change the lock level

Yes, w/code

No

Change morning dose

No

Yes

Start an extra dose

No

Yes

Start a morning dose

No

Yes

Change continuous rate

Yes

No

Change extra dose

Yes

No

Clear given amount

Yes

No

Access to functions

Yes, w/code

No

Extra dose lockout

Yes, w/code

No

Morning dose lockout

Yes, w/code

No

Upstream occlusion Sensor On/Off

Yes, w/code

No

General Description

This table lists the operations that are accessible in lock level 0 (LL0) while the pump is stopped and running. LL0 permits complete access to all programming and operating functions.

Biomed Functions

9

Section 1: General Description

General Description

Lock Levels 1 and 2 (LL1, LL2) Table This table lists the operations that are accessible in lock level 1 (LL1) and lock level 2 (LL2) while the pump is stopped and running. LL1 permits limited control of pump programming and operations. LL2 permits only minimal control of pump operations. Stopped

Running

Pump Operations and Programming

LL1

LL2

Any Lock Level

Stop/Start the pump

Yes

Yes

Yes

Reset reservoir volume

Yes

Yes

No

Prime

Yes

No

No

Change the lock level

Yes, w/code

Yes, w/code

No

Change morning dose

No

No

Yes*

Start an extra dose

No

No

Yes

Start a morning dose

No

No

Yes

Change continuous rate

Yes*

No

No

Change extra dose

Yes*

No

No

Clear given amount

Yes

No

No

*When in LL1, you can program up to the LL0 value. No programming

is allowed in LL2.

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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 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.

• 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 and non-delivery of medication, which could compromise patient treatment. CAUTION: Do not use rechargeable NiCd 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 properly.

11

Pump Setup & Programming

WARNING: • Always have new batteries available for replacement. If power is lost, non-delivery of medication will occur, which could compromise patient treatment.