DUOPA® is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Enteral suspension: 4.63 mg carbidopa and 20 mg levodopa per mL in a single-use cassette. Each cassette contains approximately 100 mL of suspension.

DUOPA is contraindicated in patients who are currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions (7.1 and 7.2)].

The following serious adverse reactions are discussed below and elsewhere in labeling:

• Gastrointestinal and Gastrointestinal Procedure-Related Risks [see Warnings and Precautions (5.1)]
  
• Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.2)]
  
• Orthostatic Hypotension [see Warnings and Precautions (5.3)]
  
• Hallucinations/Psychosis/Confusion [see Warnings and Precautions (5.4)]
  
• Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.5)]
  
• Depression and Suicidality [see Warnings and Precautions (5.6)]
  
• Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.7)]
  
• Dyskinesia [see Warnings and Precautions (5.8)]
  
• Neuropathy [see Warnings and Precautions (5.9)]
  
• Cardiovascular Ischemic Events [see Warnings and Precautions (5.10)]
  
• Laboratory Test Abnormalities [see Warnings and Precautions (5.11)]
  
• Glaucoma [see Warnings and Precautions (5.12)]

Management of acute overdosage with DUOPA is the same as management of acute overdosage with levodopa. Pyridoxine is not effective in reversing the actions of oral immediate-release carbidopa-levodopa.

In the event of an overdosage with DUOPA, the infusion should be stopped and the pump disconnected immediately. Administer intravenous fluids and maintain an adequate airway. Patients should receive electrocardiographic monitoring for arrhythmias and hypotension.

DUOPA is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid.

Carbidopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (2S)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropanoic acid monohydrate. Its empirical formula is C10H14N2O4•H2O, and its structural formula is:

The content of carbidopa in DUOPA is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. The 4.63 mg/mL of anhydrous carbidopa is equivalent to 5.0 mg/mL of carbidopa.

Levodopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (2S)-2-Amino-3-(3,4-dihydroxyphenyl) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:

The inactive ingredients in DUOPA are carmellose sodium and purified water.

The efficacy of DUOPA was established in a randomized, double-blind, double-dummy, active-controlled, parallel group, 12-week study (Study 1) in patients with advanced Parkinson's disease who were levodopa-responsive and had persistent motor fluctuations while on treatment with oral immediate-release carbidopa-levodopa and other Parkinson's disease medications.

Patients were eligible for participation in the studies if they were experiencing 3 hours or more of “Off” time on their current Parkinson's disease drug treatment and they demonstrated a clear responsiveness to treatment with levodopa. Seventy-one (71) patients enrolled in the study and 66 patients completed the treatment (3 patients discontinued treatment because of adverse reactions, 1 patient for lack of effect, and 1 patient for non-compliance).

Patients enrolled in this study had a mean age of 64 years and disease duration of 11 years. Most patients (89%) were taking at least one concomitant medication for Parkinson’s disease (e.g., dopaminergic agonist, COMT-inhibitor, MAO-B inhibitor) in addition to oral immediate-release carbidopa-levodopa. Thirty nine percent of patients were taking two or more of such concomitant medications.

Patients were randomized to either DUOPA and placebo capsules or placebo suspension and oral immediate-release carbidopa-levodopa 25/100 mg capsules. Patients in both treatment arms had a PEG-J device placement. DUOPA or placebo-suspension was infused over 16 hours daily through a PEG-J tube via the CADD®-Legacy 1400 model ambulatory infusion pump. The mean daily levodopa dose was 1117 mg/day in the DUOPA group and 1351 mg/day in the oral immediate-release carbidopa-levodopa group.

The clinical outcome measure in Study 1 was the mean change from baseline to Week 12 in the total daily mean “Off” time, based on a Parkinson's disease diary. The "Off" time was normalized to a 16-hour awake period, based on a typical person's waking day and the daily infusion duration of 16 hours. The mean score decrease (i.e., improvement) in “Off” time from baseline to Week 12 for DUOPA was significantly greater (p=0.0015) than for oral immediate-release carbidopa-levodopa. Additionally, the mean score increase (i.e., improvement) in “On” time without troublesome dyskinesia from baseline to Week 12 was significantly greater (p=0.0059) for DUOPA than for oral immediate-release carbidopa-levodopa. The treatment difference (DUOPA – oral immediate release carbidopa-levodopa) for decrease in “Off” time was approximately 1.9 hours and the treatment difference for the increase in “On” time without troublesome dyskinesia was approximately 1.9 hours. Results of Study 1 are shown in Table 4.

Figure 2 shows results over time according to treatment for the efficacy variable (change from baseline in “Off” time) that served as the clinical outcome measure at the end of the trial at 12 weeks.

Figure 2. Change in “Off” Time Over 12 Weeks.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Administration Information

Ask patients if they have had any previous surgery in the upper part of their abdomen that may lead to difficulty in performing the gastrostomy or jejunostomy [see Dosage and Administration (2.3)].

Advise patients that foods that are high in protein may reduce the effectiveness of DUOPA [see Drug Interactions (7.5) and Clinical Pharmacology (12.3)].

Interruption of DUOPA Infusion

If the patient anticipates disconnecting the pump for a short period of time (less than 2 hours such as to swim, shower, or short medical procedure), no supplemental oral medication is needed, but the patient may be advised to take an extra-dose of DUOPA before disconnecting. Instruct the patient to stop the continuous rate, turn off the pump, clamp the cassette tube, disconnect the tubing, and replace the red cap on the cassette tube. The DUOPA cassette can remain attached to the pump until the tubing is reconnected. Refer the patient to the Patient Instructions for Use for additional information (i.e., changing the DUOPA Cassette: disconnecting Steps 1-5 and reconnecting Steps 10-16).

Advise the patient to contact their healthcare provider and to take oral carbidopa-levodopa until the patient is able to resume DUOPA infusion, if the patient will have prolonged interruption of therapy lasting more than 2 hours [see Dosage and Administration (2.4)].

Gastrointestinal and Gastrointestinal Procedure-Related Risks

Inform patients of the gastrointestinal procedure-related risks including abscess, bezoar, ileus, implant site erosion/ulcer, intestinal hemorrhage, intestinal ischemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumonia (including aspiration pneumonia), pneumoperitoneum, post-operative wound infection and sepsis. Advise patients of the symptoms of the above listed complications and instruct them to contact their healthcare provider if they experience any of these symptoms [see Warnings and Precautions (5.1)].

Falling Asleep during Activities of Daily Living and Somnolence

Alert patients to the potential sedating effects caused by DUOPA, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a common adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with DUOPA to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.

Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with DUOPA or when taking a concomitant medication that increases plasma levels of levodopa [see Warnings and Precautions (5.2)].

Orthostatic Hypotension

Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking DUOPA. Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with DUOPA [see Warnings and Precautions (5.3)].

Hallucinations/Psychosis/Confusion

Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations) and other symptoms of psychosis can occur while taking DUOPA. Tell patients to report hallucinations, abnormal thinking, psychotic behavior or confusion to their healthcare provider promptly should they develop [see Warnings and Precautions (5.4)].

Impulse Control/Compulsive Behaviors

Advise patients that they may experience impulse control and/or compulsive behaviors while taking DUOPA. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with DUOPA [see Warnings and Precautions (5.5)].

Depression and Suicidality

Inform patients that they may develop depression or experience worsening of depression while taking DUOPA. Instruct patients to contact their healthcare provider if they experience depression, worsening of depression, or suicidal thoughts [see Warnings and Precautions (5.6)].

Withdrawal-Emergent Hyperpyrexia and Confusion

Advise patients to contact their healthcare provider before stopping DUOPA. Tell patients to inform their healthcare provider if they develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness [see Warnings and Precautions (5.7)].

Dyskinesia

Inform patients that DUOPA may cause or exacerbate pre-existing dyskinesias [see Warnings and Precautions (5.8)].

Neuropathy

Inform patients that neuropathy may develop or they may experience worsening neuropathy on DUOPA, and to contact their healthcare provider if they develop any symptoms or features suggesting neuropathy [see Warnings and Precautions (5.9)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant during therapy [see Use in Specific Populations (8.1)].

Lactation

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)].

Manufactured by AbbVie Inc., North Chicago, IL 60064, USA
or by Fresenius Kabi Norge AS, 1788 Halden, Norway
For AbbVie Inc.
North Chicago, IL 60064, USA

© 2019-2022 AbbVie Inc.
20070164 Revised March 2022

MEDICATION GUIDE

DUOPA (Do-oh-pa)

(carbidopa and levodopa) enteral suspension

Read this Medication Guide before you start using DUOPA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about DUOPA?

DUOPA can cause serious side effects, including:

• Stomach and intestine (gastrointestinal) problems and problems from the procedure you will need to have to receive DUOPA (gastrointestinal procedure-related problems).
  Some of these problems may require surgery and may lead to death.
  ○ a blockage of your stomach or intestines (bezoar)
  ○ stopping movement through intestines (ileus)
  ○ drainage, redness, swelling, pain, feeling of warmth around the small hole in your stomach wall (stoma)
  ○ bleeding from stomach ulcers or your intestines
  ○ inflammation of your pancreas (pancreatitis)
  ○ infection in your lungs (pneumonia)
  ○ air or gas in your abdominal cavity
  ○ skin infection around the intestinal tube, pocket of infection (abscess), infection in your blood (sepsis) or abdominal cavity may occur, after surgery
  ○ stomach pain, nausea or vomiting
  
• Tell your healthcare provider right away if you have any of the following symptoms of stomach and intestine problems and gastrointestinal procedure-related problems:
  ○ stomach (abdominal) pain
  ○ constipation that does not go away
  ○ nausea or vomiting
  ○ fever
  ○ blood in your stool or a dark tarry stool (melanotic stool)

You will need to have a procedure to make a small hole (called a “stoma”) in your stomach wall to place a gastro-jejunostomy tube (called a PEG-J tube) in an area of your small intestine called the jejunum. DUOPA is delivered directly to your small intestine through this tube. Your healthcare provider will talk to you about the stoma procedure. Before the stoma procedure, tell your healthcare provider if you have ever had a surgery or problems with your stomach.

Talk to your healthcare provider about what you need to do to care for your stoma. After the procedure, you and your healthcare provider will need to regularly check the stoma for any signs of infection.

If your PEG-J tube becomes kinked, knotted, or blocked this may cause you to have worsening of your Parkinson’s symptoms or recurring movement problems (motor fluctuations). Call your healthcare provider if your Parkinson’s symptoms get worse or you have slow movement while you are treated with DUOPA.

What is DUOPA?

DUOPA is a prescription medicine used for treatment of advanced Parkinson's disease. DUOPA contains 2 medicines, carbidopa and levodopa.

DUOPA should not be given to children (younger than 18 years).

Who should not use DUOPA?

Do not use DUOPA if you:

• take a medicine called a nonselective Monoamine Oxidase (MAO) Inhibitor (such as phenelzine or tranylcypromine) or have taken a nonselective MAO Inhibitor within the last 14 days.
  Ask your healthcare provider or pharmacist if you are not sure if you take an MAO Inhibitor.

What should I tell my healthcare provider before using DUOPA?

Before you use DUOPA, tell your healthcare provider if you:

• have or have had stomach ulcers or stomach surgery
  
• have low blood pressure (hypotension) or if you feel dizzy or faint, especially when getting up from sitting or lying down
  
• have had problems with fainting (syncope)
  
• feel sleepy or have fallen asleep suddenly during the day
  
• have or have had depression (feelings of hopelessness or sadness) or any mental problems
  
• drink alcohol. Alcohol can increase the chance that DUOPA will make you feel sleepy or fall asleep when you should be awake
  
• have trouble controlling your muscles (dyskinesia)
  
• have nerve problems (peripheral neuropathy)
  
• have or have had heart problems, an abnormal heart rate or have had a heart attack in the past
  
• have or have had high blood pressure (hypertension)
  
• have eye problems that cause increased pressure in your eye (glaucoma)
  
• have a history of attacks of suddenly falling asleep and without warning
  
• have any other medical conditions
  
• are pregnant or planning to become pregnant. It is not known if DUOPA will harm your unborn baby
  
• are breastfeeding or plan to breastfeed. DUOPA can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take DUOPA

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements.

Using DUOPA with certain other medicines may affect each other and cause serious side effects.

Especially tell your healthcare provider if you take:

• medicines used to treat high blood pressure (hypertension)
  
• medicines used to treat depression called nonselective Monoamine Oxidase (MAO) Inhibitor (such as phenelzine or tranylcypromine) or have taken one within the last 14 days
  
• dopamine D2 receptor antagonists (antipsychotics or metoclopramide), and isoniazid
  
• iron or multivitamins with iron

Eating high protein foods may affect how DUOPA works. Tell your healthcare provider if you change your diet.

Ask your healthcare provider or pharmacist for a list of these medicines or foods if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use DUOPA?

• Use DUOPA exactly as your healthcare provider tells you to use it.
  
• Your healthcare provider should show you how to use DUOPA before you use it for the first time. Ask your healthcare provider or pharmacist if you have any questions.
  
• Your prescribed dose of DUOPA will be programmed into your pump by a healthcare provider and should only be changed by your healthcare provider or while you are with your healthcare provider.
  
• Do not stop using DUOPA or change your dose unless you are told to do so by your healthcare provider. Tell your healthcare provider if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.
  
• Keep a supply of oral carbidopa-levodopa immediate release (IR) tablets with you in case you are unable to give your DUOPA infusion.
  
• DUOPA is given continuously over 16 hours through a tube that is put into your stomach called a PEG-J. A small pump (CADD-Legacy 1400) is used to move DUOPA from the medication cassette through your PEG-J tube.
  
• Your DUOPA dose has three parts:
  ○ a morning dose
  ○ a continuous dose
  ○ extra doses
  
• DUOPA can also be given for a short time (short-term) through a tube put into your nose called a naso-jejunal (NJ) tube.
  
• The CADD-Legacy 1400 portable infusion pump should be used to give DUOPA through your PEG-J tube. See the Instructions for Use that comes with your CADD-Legacy 1400 portable infusion pump for complete instructions on how to use the pump.
  
• DUOPA comes in a small plastic container (cassette) that you connect to the pump to get your medicine.
  ○ Each cassette can only be used 1 time. An opened cassette should not be reused.
  ○ The cassette should not be used for longer than 16 hours.
  ○ The cassette should be thrown away at the end of the infusion, even if there is some medicine still in the cassette.
  
• Disconnect the pump from your PEG-J tube after the 16 hour dosing time is finished. Use a syringe filled with room temperature water to flush your PEG-J tube. See the “Instructions for Use” for more information about how to flush your PEG-J tube with a syringe.
  
• After your daily DUOPA infusion, you should take your usual night-time dose of oral carbidopa-levodopa tablets as prescribed.
  
• If you stop your DUOPA infusion for more than 2 hours during your 16 hour dosing time for any reason, call your healthcare provider and take oral carbidopa-levodopa as prescribed until you are able to restart your DUOPA infusion.
  
• If you stop your DUOPA infusion for less than 2 hours, you do not need to take oral carbidopa-levodopa, but your healthcare provider may tell you to take an extra dose of DUOPA.

What should I avoid while using DUOPA?

• Do not drive, operate machinery, or do other activities until you know how DUOPA affects you. Sleepiness and falling asleep suddenly caused by DUOPA can happen as late as 1 year after you start your treatment.

What are the possible side effects of DUOPA?

DUOPA may cause serious side effects, including:

• See “What is the most important information I should know about DUOPA?”
  
• Falling asleep during normal daily activities. DUOPA may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating.
  ○ You could fall asleep without any warning.
  ○ Some people using DUOPA have had car accidents because they fell asleep while driving.
  Do not drive or operate machinery until you are sure how DUOPA affects you.
  Tell your healthcare provider if you take other medicines that can make you sleepy such as sleep medicines, antidepressants, or antipsychotics.
  
• Low blood pressure when you sit or stand up quickly. After you have been sitting or lying down, stand up slowly until you know how DUOPA affects you. This may help reduce the following symptoms while you are using DUOPA:
  ○ dizziness
  ○ nausea
  ○ sweating
  ○ fainting
  
• Seeing things that are not there, hearing sounds or feeling sensations that are not real (hallucinations). Hallucinations can happen in people who use DUOPA. Tell your healthcare provider if you have hallucinations.
  
• Unusual urges. Some people taking certain medicines to treat Parkinson’s disease, including DUOPA, have reported problems, such as gambling, compulsive eating, compulsive shopping, and increased sex drive.
  If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
  
• Depression and suicide. DUOPA can cause depression or make your depression worse. Pay close attention to sudden changes in your mood, behavior, thoughts, or feelings. Call your healthcare provider right away if you feel depressed or have thoughts of suicide.
  
• Uncontrolled sudden movements (dyskinesia). If you have new dyskinesia, or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of DUOPA or other medicines to control your Parkinson’s disease may need to be adjusted.
  
• Progressive weakness or numbness or loss of sensation in the fingers or feet (neuropathy).
  
• Heart attack or other heart problems. Tell your healthcare provider if you have experienced increased blood pressure, a fast or irregular heartbeat or chest pain.
  
• Abnormal blood tests. DUOPA may cause changes in certain blood tests, especially certain hormone and kidney function blood tests.
  
• Worsening of the increased pressure in your eyes (glaucoma). The pressure in your eyes should be checked after starting DUOPA.
  
• The most common side effects of DUOPA include:
  ○ swelling of legs and feet
  ○ nausea
  ○ high blood pressure (hypertension)
  ○ depression
  ○ mouth and throat pain

Call your healthcare provider or get medical care right away if you have any of the above symptoms. Your healthcare provider will tell you if you should stop treatment with DUOPA and if needed, tell you how to discontinue DUOPA.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of DUOPA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store DUOPA?

• Store DUOPA in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not freeze.
  
• Use at room temperature. Take one DUOPA cassette out of the carton and out of the refrigerator 20 minutes prior to use. Use the product at room temperature or you may not get the right amount of medication.
  
• Protect the cassette from light and keep it in the carton before using.
  
• Use DUOPA before the expiration date printed on the cassette.

Keep DUOPA and all medicines out of the reach of children.

General information about the safe and effective use of DUOPA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DUOPA for a condition for which it was not prescribed. Do not give DUOPA to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about DUOPA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about DUOPA that was written for healthcare professionals.

For more information go to www.DUOPA.com or call 1-844-386-4968.

What are the ingredients in DUOPA?

Active ingredients: carbidopa and levodopa

Inactive ingredients: carmellose sodium and purified water

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by AbbVie Inc., North Chicago, IL 60064, USA
or by Fresenius Kabi Norge AS, 1788 Halden, Norway
For AbbVie Inc.
North Chicago, IL 60064, USA

© 2019-2022 AbbVie Inc.
20070164 Revised: March 2022

INSTRUCTIONS FOR USE

Note: The original design of the Y-Connector is represented in the Figures throughout this Instructions for Use.

This Instructions for Use provides information for the CADD-Legacy® model 1400 pump only. There are other CADD-Legacy® pump models available. Read the label on the back of the pump to make sure it is a model 1400 pump.
Your healthcare provider prescribed DUOPA for you. Your healthcare provider programs your prescription into the CADD-Legacy® 1400 pump. The CADD-Legacy® 1400 pump is approved for use with DUOPA. DUOPA is provided as medication inside cassettes that connect to the CADD-Legacy® 1400 pump.

The pump delivers DUOPA in 3 ways:

• Continuous Rate: Steady delivery of DUOPA delivered throughout the day while pump is on
  
• Morning Dose: A large dose of DUOPA given each morning
  
• Extra Dose: A small dose of DUOPA given as needed during the day

You will need the following items to complete these steps:

• Pump
  
• DUOPA cassette
  
• Coin, like a quarter
  
• Carrying bag
  
• Syringe
  
• Syringe connector
  
• Room temperature water

WARNINGS and CAUTIONS

Failure to follow the Warnings and Cautions below could cause return of your symptoms, damage to the pump, serious injury, or may lead to death in rare cases.

WARNINGS

• Only use the pump in a manner described in this Instructions for Use, after you have received training by your healthcare provider.
  
• To avoid explosion hazard, do not use the pump near flammable explosive gases.
  
• Only use extension sets that are approved for use with DUOPA (See the Full Prescribing Information for DUOPA), pay attention to all warnings and cautions associated with their use.
  
• Always have new batteries available for replacement. If power is lost, DUOPA will not be delivered.
  
• 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 correctly secured. This may cause loss of power and DUOPA will not be delivered.
  
• If the pump is dropped or hit, look at the pump for damage. Do not use a pump that is damaged or is not functioning correctly.
  
• If a gap is present between the battery door and the pump housing, this means the door is not correctly latched. If the battery door becomes detached or loose, the batteries will not be correctly secured. This could cause loss of power and DUOPA will not be delivered.
  
• Use only DUOPA cassettes for pump accuracy and to make sure the pump works correctly. Attach the DUOPA cassette correctly. A detached or incorrectly attached DUOPA cassette could cause a problem with getting your DUOPA.

CAUTIONS

• Use only Smiths Medical accessories and replacement parts for the pump as using other brands may adversely affect the operation of the pump.
  
• Do not operate the pump at temperatures below 36°F (2°C) or above 104°F (40°C).
  
• Do not store the pump at temperatures below -4°F (-20°C) or above 140°F (60°C). Do not store the pump with a DUOPA cassette attached. Use the protective cassette provided when storing the pump.
  
• Do not keep the pump in humidity levels below 20% or above 90% relative humidity.
  
• Do not place the pump in cleaning fluid or water, or allow solution to soak into the pump, keypad, or battery compartment.
  
• Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners.
  
• Do not use rechargeable NiCd or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (heavy duty) batteries. They do not provide enough power for the pump to operate correctly.
  
• Do not store the pump for long periods of time with the batteries installed. Battery leakage could damage the pump.

For instructions on changing a DUOPA cassette, see Changing the Cassette.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

03-B884 Revised: March 2019

Legacy 1400 Operator's Manual

CADD-Legacy® 1400 Pump
Model 1400

This online version differs from the printed version. Certain information that is not intended for patients has been removed.

This operator’s manual is for clinician use only. Read the entire operator’s manual before operating the pump.

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

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.
  
• 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.

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.
  
• 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.

1.0 General Description

Introduction

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.

Refer to AbbVie’s full prescribing information for DUOPA (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions.

Symbols

Pump Diagram

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. 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.

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.

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.

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.

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.

*Does not appear on the main screen if reservoir volume is programmed to Not In Use.

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**

Lock Level 0 (LL0) Table

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.

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.

*When in LL1, you can program up to the LL0 value. No programming is allowed in LL2.

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.

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.

3. Install the new batteries in the compartment, making sure the battery strap is positioned correctly under the batteries.

NOTE:

• 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 will remain blank, and you will not hear a beep.
  
• 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.

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. All of the display indicators, the software revision, and each parameter will appear briefly.

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.
  
• At the rate of 100 ml per day, alkaline batteries will usually last about 7 days.
  
• The power of the batteries will be quickly depleted at temperatures below 10°C (50°F).

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.)
  
• The software revision will appear.
  
• The display will turn on, showing a series of blocks. Look for any blank areas, which would indicate a faulty display.
  
• The display will turn off briefly.
  
• The pump’s program screens will appear, followed by the current lock level setting. The pump will beep after each screen. If messages appear, see Messages and Alarms Table, Section 5 for further explanation and instruction.
  
• When power up is complete, 6 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

If you attempt to skip screens before the pump is powered up, it will not respond.

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

The current lock level will appear. (If the lock level is already LL0, press

to exit.)

**Text Omitted**

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

• To change a setting, press

or

until the desired setting appears. (Press and hold these keys to change values with increasing speed.)

• Press

within 25 seconds to confirm a change or the screen will revert to the previous setting.

• If any key other than

is pressed, Value not saved will appear. Press

to return to the screen being programmed, scroll to the desired value, and press

• Press

to advance to the next screen.

• To leave a setting unchanged, press

to go to the next screen.

Delivery Methods

The CADD-Legacy® 1400 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. Ranges and programming increments are listed in the Specifications in Section 5.

Programming Screens

These are the programming screens for the CADD-Legacy® 1400 pump. Descriptions of the screens follow.

Reservoir Volume

NOTE: The default setting for Reservoir Volume is Not in Use. Programming a reservoir volume value is not required for general use, but is available at provider discretion.

If you wish to use the reservoir volume feature, enter the volume of medication contained in the filled medication cassette reservoir. The reservoir volume value decreases as the pump delivers medication or as you prime the tubing. When you change the medication cassette reservoir, reset the reservoir volume value 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 reservoir volume value could be set higher than the capacity of the medication cassette reservoir. Be sure to program the reservoir volume to reflect the actual volume in the reservoir.

Continuous Rate

Enter the continuous rate of medication 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.

Extra Dose

Enter the amount of medication to be delivered when the patient presses

If the prescription does not call for an extra dose, enter zero.

NOTE: If you intend to run the pump in lock level 1 so the extra dose can be varied, you should enter the maximum allowable dose while programming in lock level 0. After programming, you may then change to lock level 1 and decrease the dose to its starting value. See Programming with Upper Limits, Adjusting Doses in LL1 at the end of Section 2.

Given

This screen shows the total amount of medication delivered since the last time this 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. When using the pump’s

key, the amount of medication used is not included in the Given amount.

Other Programming Information

The morning dose should be programmed separately following programming of the above. Information on programming the morning dose can be found later in this section.

Programming Delivery

To program the pump, enter the prescribed values.

1. Begin at the main screen.

• Make sure the pump is in LL0.
  
• Make sure STOPPED appears on the main screen.
  
• Press

to begin.

 2. Enter the reservoir volume (optional – not required for general use).

NOTE: The default setting for Reservoir Volume is Not in Use. Programming a reservoir volume value is not required for general use, but is available at provider discretion.

• Press

or

to select the volume in the filled medication cassette reservoir. (If you do not wish to use the reservoir volume feature, scroll down to Not In Use located before 1 or after 9999.)

• Press

• Press

3. Enter the continuous rate.

• Press

or

to select the desired continuous rate.

• Press

• Press

4. Enter the extra dose amount.

• Press

or

to select the desired extra dose amount.

• Press

• Press

 

NOTE: If required, program the extra dose lockout time, as instructed in Section 4, Biomed Functions.

5. Clear the amount given.

• Press

if you wish to clear the amount given.

• 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

To program a morning dose the pump must be running and a medication cassette reservoir must be attached.

To program a morning dose

1. Make sure the pump is running and in LL0 or LL1. Start the pump, if necessary.
NOTE: In LL0, programming in the full range is possible. In LL1, you can program up to the LL0 value.

2. Press

The current morning dose value will appear.

3. Press

or

to select the desired morning dose value.

4. Press

to enter the value into the pump’s memory. (If desired, press

again to begin delivering the morning dose.)

Once entered, the morning dose amount is retained in the pump’s memory. The patient can then press

twice to display and deliver the morning dose.

NOTE: If required, program the morning dose lockout time, as instructed in Section 4, Biomed Functions.

Removing a Medication Cassette Reservoir

To remove the medication cassette reservoir from the pump

1. Stop the pump.

2. Close the tubing clamp. If necessary, disconnect the tubing from the enteral access device.

3. Insert a coin into the slot in the cassette latch and turn it clockwise. The latch will pop out when you unlatch the cassette (the part of the medication cassette reservoir that attaches to the bottom of the pump).

4. A continuous alarm will sound and the pump will display No Disposable, Clamp Tubing (the pump is not sensing proper cassette attachment). The alarm may be silenced by pressing

or

5. Remove the cassette hooks from the pump hinge pins.

Attaching a Medication Cassette Reservoir

Obtain a new, filled medication cassette reservoir.

After attaching the medication cassette reservoir, proceed to the reservoir volume screen to reset the value for the volume, and then prime the tubing.

Priming the Tubing 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 medication cassette reservoir but wish to prime the fluid path, you may follow the same procedure.

1. Make sure the tubing is disconnected from the patient and the tubing clamp is open.

2. Press and hold

You will hear a single beep, and the word Prime and 3 sets of dashes, each accompanied by a beep, will appear on the display.

3. After Prime and 3 sets of dashes appear, release

4. Press and hold

again to fill the fluid path. The screen displays Priming . . . and you will hear a short beep each time the pump goes through a delivery cycle.

NOTE: Medication delivered during priming is subtracted from the reservoir volume, but is not added to the given screen since this amount 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.

NOTE: Each time you press and hold

you pump a maximum of 1 ml of medication into the tubing. The pumping action will stop automatically when 1 ml has been delivered. Release

if you finish priming the fluid path sooner. If the fluid path is not fully primed, repeat the above priming procedure.

6. Connect the tubing to the patient’s enteral access device.

7. Set the lock level for the patient (see Setting the Lock Level for the Patient in this section).

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.

To change the lock level

**Text Omitted**

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. Then, when necessary, you can adjust values up to the maximum value that was programmed in LL0.

Programming the pump to use this feature

1. During initial programming in LL0, enter the upper limit values for the continuous rate, extra dose and/or morning dose. (These will be the maximum values when the pump is in LL1.)
   
2. After you are finished programming, change the lock level to LL1.
   
3. Decrease the continuous rate, extra dose and/or morning dose to its starting value, then press

Adjusting the rate or dose while the pump is in use

• If it becomes necessary to increase or decrease the continuous rate, and/or extra dose during the course of therapy, stop the pump but remain in LL1.
  
• To increase or decrease the morning dose, the pump must be in LL1, but it must remain running.

1. To change the continuous rate or extra dose, press

until the continuous rate or extra dose screen appears.

To change the morning dose, press

2. Press

or

to select the desired value, then press

NOTE: You will not be able to adjust the continuous rate, extra dose, or morning dose beyond the value originally programmed in LL0.

3. Restart the pump if appropriate.

3.0 Operating the Pump

Starting the Pump

When you start the pump, programmed values will be automatically reviewed. Then medication 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. Refer to the Messages and Alarms Table in Section 5.

To start the pump

1. Press and hold

Starting and 3 sets of dashes appear on the display; then the dashes disappear 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 3 beeps every 5 minutes.

To stop the pump

1. Press and hold

Stopping and 3 sets of dashes 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 disconnected from the patient and it is going to be stored for short periods of time.

To turn the pump off

1. Press and hold

Turning off and 3 sets of dots will appear one-by-one on the pump’s display, each accompanied by a single beep.

2. Release

The display turns off.

To turn the pump on

1. Press and hold

until the display turns on.

2. Release

The pump will power up and automatically review all screens.

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 medication, 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. The lockout time is determined by the value entered in Morning Dose Lockout, in biomed functions. The extra dose lockout setting has no effect on morning dose frequency. A morning dose may be stopped in progress.

NOTE: A morning dose cannot be started while an extra dose or another morning dose is in progress.

To start a morning dose

To program a morning dose, the pump must be running and a medication cassette reservoir must be attached.

NOTE: The

key must be pressed twice for morning dose delivery to start.

1. Make sure the pump is running (in any lock level). Start the pump if necessary.
   
2. Press

The current morning dose value (or the default value of 0 ml) will appear UNLESS the morning dose is currently locked out (in which case the screen will not appear). If the desired morning dose amount appears in the display, press

again to begin delivery.

NOTE: If the desired morning dose amount does not appear in the display, program the desired morning dose amount as instructed in Section 2, Pump Setup and Programming.

The screen will show the value decreasing as the morning dose is delivered.

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. The lockout time is determined by the value entered in Extra Dose Lockout, in biomed functions.

NOTE: An extra dose cannot be started while another extra dose or a morning dose is in progress.

To start an extra dose

1. Make sure the pump is running (in any lock level). Start the pump if necessary.
   
2. Press

Two beeps will sound and the pump will begin delivering the extra dose.

As the extra dose is delivered, the main screen will show DOSE in place of RUN.

Stopping an Extra Dose or Morning Dose

An extra dose or morning dose can be stopped in progress. The pump may be in any lock level.

To stop an extra dose or morning dose in progress

• Press and hold

to stop the pump. All delivery is stopped, including the continuous rate.

Resetting the Reservoir Volume

NOTE: The default setting for Reservoir Volume is Not in Use. Programming a reservoir volume value is not required for general use, but is available at provider discretion.

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. Press

to reset the volume to the programmed value.

4.0 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 (LL0).

To access the Biomed Functions

**Text Omitted**

4. Press

to select the setting you wish to view or change, then follow the instructions in this section for the appropriate screen.

NOTE: To leave a biomed function setting unchanged, press

5. To exit the biomed functions, press

until you get to the screen that reads, NEXT for Biomed, ENTER for Main.

6. Press

to return to the main screen.

Extra Dose Lockout

The extra dose lockout time determines how often a patient can receive an extra dose of medication. The lockout time is the minimum amount of time which must elapse between the start of one dose and the start of the next.

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 which must elapse between the start of one dose and the start of the next.

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 medication cassette reservoir is detected, an alarm will sound, delivery will stop, and the display will show Upstream Occlusion.

5.0 Reference

Messages and Alarms, Alphabetical List

If the medication cassette reservoir or the battery door is loose or damaged, do not use the pump. Immediately stop the pump, close the tubing clamp, and contact Smiths Medical.

• If the pump is accidentally dropped in water, retrieve it quickly, dry it off with a towel, and contact Smiths Medical.

Cleaning the Pump and Accessories

NOTE: Refer to the Instructions for Use for each accessory before proceeding with cleaning.

The following solutions may be used to clean the pump and accessories, unless otherwise specified:

• Soap solution
  
• Benzalkonium chloride concentrate (0.13%)
  
• Glutaral concentrate, USP (2%)
  
• 10% solution of household bleach (one part household bleach to 9 parts water)
  
• Alcohol, USP (93%)
  
• Isopropyl Alcohol, USP (99%)
  
• Chlorhexidine gluconate (4%)
  
• PDI Super Sani-Cloth®
  
• MadaCide, Mada Medical

1. Dampen a soft, lint-free cloth with cleaning solution. Apply the solution to the exterior surface of the pump (per manufacturer’s instructions). Do not allow the solution to soak into the pump or accessory.
   
2. Wipe the entire surface dry with another soft, lint-free cloth. Allow the pump to dry completely before use.

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.
  
  OR

• Pre-moistened alcohol swab

1. Using a swab wetted with alcohol, rub the entire battery contact for a minimum of 10 back and forth cycles (20 total wipes over the contact).
   
2. Using a clean surface of the swab, repeat process for second battery contact.
   
3. Using a clean swab wetted with alcohol, rub each battery contact again, a minimum of 4 back and forth cycles (8 total wipes over the contact).
   
4. Allow the contacts to dry completely before use.

Exposure to Radiation, Ultrasound, Magnetic Resonance Imaging (MRI), or Use near ECG Equipment

Continuous Rate Scroll Ranges

Extra Dose, Morning Dose Scroll Ranges

Technical Description

Specifications (Nominal)

Accuracy Test Results

The following graphs are designed to show flow accuracy of the infusion system plotted against given time periods. The medication cassette reservoir used for flow accuracy tests was supplied by AbbVie.

Electromagnetic Emissions and Immunity Declarations

Compliance using:

1. 115VAC/60HZ to 8VDC Power Adapter (US) with a cord length of 274 ± 10 cm (108 ± 4 in).
   
2. Remote Dose Cord with a length of 152 ± 5 cm (60 ± 2 in).

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.

Watchdog Timer Circuit

The microprocessor must send an appropriate signal to the watchdog circuit at least once per second. If the microprocessor does not, the watchdog circuit will time out and shut down the pump controller.

Watchdog timer circuitry is provided to monitor the status of the microprocessor and disable the motor and enable the audible alarm if the 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 startˮ 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 transistors, passive components, and 2 voltage comparators. Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on. If the motor runs for more than an average of 3 seconds, the circuit will time out and disable the motor. A unique feature of this circuit is that control lines to and from the microprocessor circuit allow the microprocessor to perform a complete functional test of the motor drive circuit without running the motor. The microprocessor performs this test function every several minutes to assure its continued functionality. An input from the watchdog circuit prevents motor operation if the 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 2 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 software, 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 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 condition.

Software Safety Features

Hardware-related Software Safety Features

Program Memory Check

At power up and at regular intervals thereafter, the program memory is tested by calculating a cyclic redundancy code (CRC) on the program and then comparing it with the CRC stored with the program.

If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication 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 medication delivery.

Motor Circuit Check

At power up and at regular intervals thereafter, the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on. If the software detects power being applied to the motor at any other time, it will sound a continuous two-tone audible alarm and will no longer 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 medication 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 switches for

,

, and

. 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 medication delivery.

Data Stored in EEPROM

Before use, data associated with delivery and stored in EEPROM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication 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 medication delivery.

Data Used in Calculations

Calculations on data used in some way to control the delivery of medication 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 medication 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 two-tone audible alarm and stop all medication delivery.

Annual Functional Inspection

Smiths Medical recommends annual functional inspections and tests on the CADD-Legacy® 1400 pump. Contact Smiths Medical to coordinate return and inspection of the pump.

Collect Separately

This product contains electronic and other components (such as batteries) that may contain materials which, if disposed of with general household waste, could be damaging to the environment.

In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, Smiths Medical requires that residents of the European Union return this product for proper disposal at the end of its useful life.

If you are unsure of the proper disposal method, contact your local distributor for specific disposal instructions.

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. 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 equipment used with the Pump.

Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without 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: Smiths Medical ASD, Inc. 1265 Grey Fox Road, St. Paul MN 55112 USA, 1 800.258.5361 (USA). 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 carefully 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 void 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 accessories. 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 Manufacturer or its agents are believed to be accurate and reliable, but do not constitute warranties.

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. 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 Computer 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 license 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 state to state.

Index

Appendix A – Pump Programming Quick Reference for Healthcare Providers

This quick reference provides for step-by-step directions for several of the common pump programming tasks performed with the CADD-Legacy® 1400 pump. Additional pump information including warnings, cautions and more information on pump operations is located in the referenced sections of the pump Operator’s Manual. Please refer to the full prescribing information for DUOPA (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions.

Begin programming the pump by:

• Attaching a medication cassette reservoir
  
• Turning on the pump

For instruction on attaching a medication cassette reservoir, see Section 2, Pump Setup and Programming.

You will need the following items to complete these steps:

• Pump
  
• Medication cassette reservoir

Changing to Lock Level 0 (LL0)

Lock level 0 (LL0) allows the health care provider to adjust settings so they are appropriate for the patient. For more information on lock levels descriptions, see Section 1, General Description. For more information on changing the lock level, see Section 2, Pump Setup and Programming.

**Text Omitted**

Pump Programming Settings

Program the pump settings to customize the medication delivery inputs for the patient. For more information see Section 2, Pump Setup and Programming.

NOTE: Ensure that the pump is in lock level 0 (LL0) and

appears on the screen.

1. Press

Check for

on the screen.

NOTE: Not in Use is the default setting for the reservoir volume. The reservoir volume feature is not required for use, but is available at provider discretion.

2. Press

again. Check for

on the screen.

3. Press

or

to select the desired continuous rate.

4. Press

Pump Status: The continuous rate is now set.

5. Press

Check for

on the screen.

6. Press

or

to select the extra dose amount.

7. Press

Pump Status: The extra dose amount is now set.

8. Press

check for

on the screen

9. Press

if you wish to clear the amount given.

10. Press

NOTE: To change a setting again, press NEXT until the appropriate screen appears. Press

or

to adjust the setting, then press

to confirm.

Changing Lockout Times

Program the dose lockout times to customize medication delivery inputs for each patient. Lockout times will determine how often a patient can deliver a morning dose and an extra dose. These values should be determined during titration. For more information on DUOPA titration, refer to the full prescribing information for DUOPA (carbidopa and levodopa) enteral suspension.

The biomed functions allow the health care provider access to the extra dose lockout and morning dose lockout settings. For more information about biomed functions, see Section 4, Biomed Functions.

NOTE:

• Ensure that the pump is in lock level 0 (LL0) and

is on the screen.

• When entering a new lockout value, any lockout time previously in effect will be cleared.

**Text Omitted**

Programming the Morning Dose

Program the morning dose to customize medication delivery for the patient. For more information, see Section 2, Pump Setup and Programming.

1. The pump must be running with a cassette attached and in LL0 or LL1. Start the pump, if necessary and confirm the lock level settings.

NOTE: In LL0, programming in the full range is possible. In LL1, you can program up to the LL0 value.

2. Press

should appear on the screen.

3. Press

or

to select the desired morning dose volume.

4. Press

to store the morning dose volume.

Setting the Lock Level

For patient use, the pump must be set to lock level 2 (LL2) or lock level 1 (LL1). For more information on lock levels descriptions, see Section 1, General Description. For more information on changing the lock level, see Section 2, Pump Setup and Programming.

**Text Omitted**

Manufacturer:
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 USA
Tel: 1 800 258 5361 (USA), +1 614 210 7300
www.smiths-medical.com

CADD, CADD-Legacy, and 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.

© 2015 Smiths Medical. All rights reserved.

2015-01
40-6756-01C

NDC 0074-3012-07

Duopa®

carbidopa and levodopa
enteral suspension

4.63 mg / 20 mg per mL

7 Cassettes (100 mL each)

THIS PACKAGE NOT INTENDED FOR
HOUSEHOLDS WITH YOUNG CHILDREN

Each mL contains 5 mg of carbidopa monohydrate

(equivalent to 4.63 mg of carbidopa anhydrous) and 20 mg of levodopa.

Pharmacist: Store frozen.
Thaw in refrigerator prior to dispensing.

See package insert for full prescribing information.

Store in the refrigerator between 36°-46°F (2°-8°C).

Protect from light.

Store cassettes in the carton until use.

Rx only

abbvie