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Legacy - Information on Duodopa from Abbott Healthcare

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<str<strong>on</strong>g>Legacy</str<strong>on</strong>g><br />

Operator’s Manual<br />

<strong>Duodopa</strong><br />

CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g> ® <strong>Duodopa</strong> ®<br />

Pump Model 1400<br />

This Operator’s Manual is for clinician use <strong>on</strong>ly.<br />

Read the entire Operator’s Manual before<br />

operating the pump.


This manual refers <strong>on</strong>ly to the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump, Model<br />

1400. There are other CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® pump models available; review the<br />

rear label of the pump to ensure it is a CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump,<br />

Model 1400, before programming. The pump is designed for enteral<br />

delivery of <strong>Duodopa</strong>® and can be programmed to deliver a C<strong>on</strong>tinuous<br />

Rate, a Morning Dose, and Extra Doses.<br />

This manual is intended for clinician use <strong>on</strong>ly. Do not permit patients to<br />

have access to this manual. The pump has 3 security levels designed to<br />

limit patient access. Do not disclose the pump’s security codes or any other<br />

informati<strong>on</strong> that would allow inappropriate access to programming and<br />

operating functi<strong>on</strong>s.<br />

The issue date of this Operator’s Manual is included <strong>on</strong> the back cover for<br />

the clinician’s informati<strong>on</strong>. In the event <strong>on</strong>e year has elapsed between the<br />

issue date and product use, the clinician should c<strong>on</strong>tact Smiths Medical<br />

to see if a later revisi<strong>on</strong> of this manual is available.<br />

Technical Assistance<br />

If you have comments or questi<strong>on</strong>s c<strong>on</strong>cerning the operati<strong>on</strong> of the<br />

CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump, please call the appropriate number<br />

given below. When calling, please specify the pump’s software revisi<strong>on</strong>.<br />

This informati<strong>on</strong> is located <strong>on</strong> the pump’s display during power up.<br />

Our staff at Smiths Medical is available to help clinicians 24 hours a day<br />

with the programming and operati<strong>on</strong> of the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>®<br />

pump.<br />

Smiths Medical ASD, Inc. European Representative<br />

St. Paul, MN 55112 USA Smiths Medical Internati<strong>on</strong>al Ltd<br />

1 800.258.5361 (USA) WD24 4LG, UK<br />

1 214.618.0218 +44 (0)1923 246434<br />

www.smiths-medical.com<br />

ii


Read this entire Operator’s Manual before operating the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>®<br />

<strong>Duodopa</strong>® pump.<br />

Failure to properly follow warnings, cauti<strong>on</strong>s, and instructi<strong>on</strong>s could result<br />

in death or serious injury to the patient, and/or damage to the pump.<br />

Warnings<br />

• This Operator’s Manual should be used by clinicians <strong>on</strong>ly. Do not<br />

permit patients to have access to this manual, as the informati<strong>on</strong><br />

c<strong>on</strong>tained would allow the patient complete access to all<br />

programming and operating functi<strong>on</strong>s. Improper programming<br />

could result in death or serious injury to the patient.<br />

• To avoid explosi<strong>on</strong> hazard, do not use the pump in the presence of<br />

flammable anesthetics or explosive gases.<br />

• The CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump and <strong>Duodopa</strong>® reservoir<br />

(supplied by <strong>Abbott</strong>) are designed for enteral delivery of <strong>Duodopa</strong>®<br />

<strong>on</strong>ly. They are NOT intended for IV or other parenteral routes of<br />

infusi<strong>on</strong>.<br />

• Do not disclose to the patient the pump’s security codes or any other<br />

informati<strong>on</strong> that would allow the patient complete access to all<br />

programming and operating functi<strong>on</strong>s.<br />

• Always have new batteries available for replacement. If power is lost,<br />

n<strong>on</strong>-delivery of <strong>Duodopa</strong>® will occur.<br />

• If the pump is dropped or hit, the battery door or tabs may break. Do<br />

not use the pump if the battery door or tabs are damaged because the<br />

batteries will not be properly secured; this may result in loss of power<br />

and n<strong>on</strong>-delivery of <strong>Duodopa</strong>®.<br />

• If a gap is present anywhere between the battery door and the pump<br />

housing, the door is not properly latched. If the battery door becomes<br />

detached or loose, the batteries will not be properly secured; this<br />

could result in loss of power and n<strong>on</strong>-delivery of <strong>Duodopa</strong>®.<br />

• Programming the pump at a delivery rate other than what is<br />

prescribed will cause over- or under-delivery of <strong>Duodopa</strong>®.<br />

iii


iv<br />

• Clamp the fluid path tubing and/or disc<strong>on</strong>nect the tubing <strong>from</strong> the<br />

enteral access device before removing the <strong>Duodopa</strong>® reservoir <strong>from</strong><br />

the pump to prevent unc<strong>on</strong>trolled delivery of <strong>Duodopa</strong>®.<br />

• Use <strong>on</strong>ly <strong>Duodopa</strong>® reservoirs supplied by <strong>Abbott</strong> to maintain pump<br />

accuracy and assure proper pump operati<strong>on</strong>s.<br />

• Use <strong>on</strong>ly extensi<strong>on</strong> sets specified by <strong>Abbott</strong>, paying particular<br />

attenti<strong>on</strong> to all warnings and cauti<strong>on</strong>s associated with their use. DO<br />

NOT use extensi<strong>on</strong> sets with anti-siph<strong>on</strong> valves.<br />

• Attach the cassette (the part of the <strong>Duodopa</strong>® reservoir that attaches<br />

to the pump) properly. A detached or improperly attached cassette<br />

could result in unc<strong>on</strong>trolled delivery of <strong>Duodopa</strong>®.<br />

• Do not prime the fluid path with the tubing c<strong>on</strong>nected to a patient as<br />

this could result in over-delivery of <strong>Duodopa</strong>®.<br />

• System delivery accuracy of the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump and<br />

attached <strong>Duodopa</strong>® reservoir is ± 10%. System delivery inaccuracies<br />

may occur as a result of back pressure or fluid resistance, which<br />

depends up<strong>on</strong> medicati<strong>on</strong> viscosity, catheter size, and extensi<strong>on</strong> set<br />

tubing.<br />

• The use of Power Supplies and a Remote Dose Cord other than those<br />

listed in the Electromagnetic Emissi<strong>on</strong>s Declarati<strong>on</strong> may result in<br />

increased emissi<strong>on</strong>s or decreased immunity of the Pump.<br />

• The Pump should not be used adjacent to or stacked with other<br />

equipment. If adjacent or stacked use is necessary, the user should verify<br />

normal operati<strong>on</strong> of the pump in the c<strong>on</strong>figurati<strong>on</strong> in which it is to be<br />

used.<br />

• There are potential health hazards associated with improper disposal<br />

of batteries, electr<strong>on</strong>ics, and c<strong>on</strong>taminated (used) reservoirs and<br />

extensi<strong>on</strong> sets. Dispose of used batteries, reservoirs, extensi<strong>on</strong> sets<br />

and other used accessories, or a pump that has reached the end of its<br />

useful life, in an envir<strong>on</strong>mentally safe manner, and according to any<br />

regulati<strong>on</strong>s that may apply.


Cauti<strong>on</strong>s<br />

• Use <strong>on</strong>ly Smiths Medical accessories and replacement parts, as using<br />

other brands may adversely affect the operati<strong>on</strong> of the pump.<br />

• Do not operate the pump at temperatures below 2°C (36°F) or above<br />

40°C (104°F).<br />

• Do not store the pump at temperatures below -20°C (-4°F) or above<br />

60°C (140°F). Do not store the pump with the <strong>Duodopa</strong>® reservoir<br />

attached. Use the Protective Cassette provided.<br />

• Do not expose the pump to humidity levels below 20% or above 90%<br />

relative humidity.<br />

• Do not sterilize the pump or <strong>Duodopa</strong>® reservoir as this could cause<br />

damage.<br />

• When the Upstream Occlusi<strong>on</strong> Sensor is turned off, the pump will not<br />

detect occlusi<strong>on</strong>s in the reservoir. Periodically inspect the reservoir<br />

for decreasing volume. Undetected occlusi<strong>on</strong>s could result in under-<br />

or n<strong>on</strong>-delivery of <strong>Duodopa</strong>®.<br />

• Do not use rechargeable NiCd or nickel metal hydride (NiMH)<br />

batteries. Do not use carb<strong>on</strong> zinc (“heavy duty”) batteries. They do not<br />

provide sufficient power for the pump to operate properly.<br />

• Do not store the pump for prol<strong>on</strong>ged periods of time with the<br />

batteries installed. Battery leakage could damage the pump.<br />

• Prior to starting <strong>Duodopa</strong>® delivery, inspect the fluid path for kinks,<br />

a closed clamp, or other obstructi<strong>on</strong>. An undetected occlusi<strong>on</strong> may<br />

result in under- or n<strong>on</strong>-delivery of <strong>Duodopa</strong>® and/or nuisance alarms.<br />

• Do not use the Remote Dose Cord to pick up or carry the pump as<br />

damage to the pump or cord could result.<br />

• When you enter a new value, any lockout time already in effect will<br />

be cleared. An Extra Dose or Morning Dose could be requested and<br />

delivered immediately up<strong>on</strong> starting the pump, which may result in<br />

over-delivery of <strong>Duodopa</strong>®.<br />

v


vi<br />

• Do not immerse the pump in cleaning fluid or water. Do not allow<br />

soluti<strong>on</strong> to soak into the pump, accumulate <strong>on</strong> the keypad, or enter<br />

the battery compartment. Moisture buildup inside the pump may<br />

damage the pump.<br />

• Do not clean the pump with acet<strong>on</strong>e, other plastic solvents, or<br />

abrasive cleaners, as damage to the pump may occur.<br />

• Do not expose the pump to ther apeutic levels of i<strong>on</strong>izing radiati<strong>on</strong><br />

as permanent damage to the pump’s electr<strong>on</strong>ic circuitry may occur.<br />

The best procedure to follow is to remove the pump <strong>from</strong> the patient<br />

during therapeutic radiati<strong>on</strong> sessi<strong>on</strong>s. If the pump must remain in the<br />

vicinity during a therapy sessi<strong>on</strong>, it should be shielded, and its ability<br />

to functi<strong>on</strong> properly should be c<strong>on</strong>firmed following treatment.<br />

• Do not use the pump in the vicinity of magnetic res<strong>on</strong>ance imaging<br />

(MRI) equipment as magnetic fields may adversely affect the<br />

operati<strong>on</strong> of the pump. Remove the pump <strong>from</strong> the patient during<br />

MRI procedures and keep it at a safe distance <strong>from</strong> magnetic energy.<br />

• This pump may interfere with ECG equipment. M<strong>on</strong>itor ECG<br />

equipment carefully when using this pump.<br />

• CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pumps are sealed units. A broken or<br />

damaged seal will, therefore, be c<strong>on</strong>sidered c<strong>on</strong>clusive evidence that<br />

the pump has been misused and/or altered, which voids any and all<br />

warranties. All service and repair of CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pumps<br />

must be performed by Smiths Medical or its authorized agents.


C<strong>on</strong>tents<br />

Warnings iii<br />

Cauti<strong>on</strong>s v<br />

1.0 General Descripti<strong>on</strong> 1<br />

Introducti<strong>on</strong> ........................................................................................................1<br />

Indicati<strong>on</strong>s ...........................................................................................................1<br />

Symbols ................................................................................................................2<br />

Pump Diagram ...................................................................................................3<br />

Descripti<strong>on</strong> of the Keys, Display, and Features ............................................4<br />

The Main Screen .................................................................................................7<br />

Lock Levels ..........................................................................................................8<br />

Security Codes ....................................................................................................8<br />

Lock Level Table .................................................................................................9<br />

2.0 Pump Setup and Programming 11<br />

Installing or Replacing the Batteries .............................................................11<br />

Watching Power Up .........................................................................................16<br />

Changing to Lock Level 0 (LL0) ....................................................................17<br />

Programming the Pump: General Instructi<strong>on</strong>s ..........................................18<br />

Delivery Methods .............................................................................................19<br />

Programming Screens .................................................................................... 20<br />

Programming Delivery ...................................................................................22<br />

Programming a Morning Dose ......................................................................23<br />

Removing a <strong>Duodopa</strong>® Reservoir ...................................................................24<br />

Attaching a <strong>Duodopa</strong>® Reservoir ...................................................................25<br />

Priming the Tubing and C<strong>on</strong>necting to the Patient ....................................27<br />

Setting the Lock Level for the Patient .......................................................... 28<br />

Programming with Upper Limits, Adjusting Doses in Lock Level 1 .......29<br />

vii


viii<br />

3.0 Operating the Pump 31<br />

Starting the Pump ............................................................................................31<br />

Stopping the Pump ..........................................................................................31<br />

Turning the Pump On/Off ..............................................................................32<br />

Starting a Morning Dose.................................................................................33<br />

Starting an Extra Dose ................................................................................... 34<br />

Stopping an Extra Dose or Morning Dose .................................................. 34<br />

Resetting the Reservoir Volume ....................................................................35<br />

4.0 Biomed Functi<strong>on</strong>s 37<br />

Overview: Accessing the Biomed Functi<strong>on</strong>s<br />

and Programming the Lockouts .............................................................37<br />

Extra Dose Lockout .........................................................................................38<br />

Morning Dose Lockout ...................................................................................39<br />

Upstream Occlusi<strong>on</strong> Sensor On/Off ............................................................. 40<br />

5.0 Reference 41<br />

Messages and Alarms, Alphabetical List ......................................................41<br />

Cleaning the Pump and Accessories ............................................................ 44<br />

Exposure to Radiati<strong>on</strong>, Magnetic Res<strong>on</strong>ance Imaging (MRI)<br />

or Use near ECG Equipment .................................................................. 46<br />

C<strong>on</strong>tinuous Rate Scroll Ranges ......................................................................47<br />

Extra Dose, Morning Dose Scroll Ranges ....................................................47<br />

Technical Descripti<strong>on</strong> ..................................................................................... 48<br />

Specificati<strong>on</strong>s (Nominal) .........................................................................49<br />

Accuracy Test Results ...............................................................................53<br />

Electromagnetic emissi<strong>on</strong>s and immunity declarati<strong>on</strong>s .....................55<br />

Safety Features and Fault Detecti<strong>on</strong> .......................................................59<br />

Software Safety Features ..........................................................................61<br />

Data Handling Software Safety Features ...............................................62<br />

Annual Functi<strong>on</strong>al Inspecti<strong>on</strong> and Testing Procedures .....................63<br />

Collect Separately .............................................................................................63<br />

Index ................................................................................................................. 64<br />

Limited Warranty ........................................................................................... 66


1.0 General Descripti<strong>on</strong><br />

Introducti<strong>on</strong><br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

The CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump provides measured <strong>Duodopa</strong>®<br />

therapy to patients in hospital or outpatient settings. Therapy should<br />

always be overseen by a physician or a certified, licensed healthcare<br />

professi<strong>on</strong>al. As appropriate to the situati<strong>on</strong>, the patient should be<br />

instructed in using and troubleshooting the pump.<br />

Indicati<strong>on</strong>s<br />

The CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump is indicated solely for enteral<br />

delivery of the drug <strong>Duodopa</strong>®. <strong>Duodopa</strong>® is c<strong>on</strong>tained in a reservoir<br />

supplied by <strong>Abbott</strong>. The <strong>Duodopa</strong>® reservoir attaches to the bottom of<br />

the pump.<br />

WARNING: The CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump and <strong>Duodopa</strong>®<br />

reservoir (supplied by <strong>Abbott</strong>) are designed for enteral delivery of<br />

<strong>Duodopa</strong>® <strong>on</strong>ly. They are NOT intended for IV or other parenteral<br />

routes of infusi<strong>on</strong>. Use of this product for medicati<strong>on</strong>s or therapies<br />

outside the intended use can result in death or serious injury to the<br />

patient.<br />

Refer to <strong>Abbott</strong>’ <strong>Duodopa</strong>® prescribing informati<strong>on</strong> for indicati<strong>on</strong>s and<br />

usage, c<strong>on</strong>traindicati<strong>on</strong>s, warnings, precauti<strong>on</strong>s, and adverse reacti<strong>on</strong>s.<br />

1<br />

General<br />

Descripti<strong>on</strong>


General<br />

Descripti<strong>on</strong><br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

Symbols<br />

O<br />

f<br />

K<br />

2<br />

Direct Current (Power Jack)<br />

Accessory Jack<br />

Cauti<strong>on</strong><br />

Class II Equipment<br />

J Type CF Equipment<br />

E Splashproof – Water splashed against pump housing will have<br />

no harmful effects (see Cleaning the Pump and Accessories,<br />

Secti<strong>on</strong> 5, for additi<strong>on</strong>al important informati<strong>on</strong>)<br />

J Date of Manufacture<br />

< Catalog Number<br />

> Serial Number<br />

6<br />

Z Collect<br />

Cauti<strong>on</strong>: Federal (USA) law restricts this device to sale by or<br />

<strong>on</strong> the order of a physician.<br />

Separately<br />

@ Authorized Representative in the European Community<br />

AUS Australian Representative<br />

P Temperature Limitati<strong>on</strong><br />

_ Humidity Limitati<strong>on</strong><br />

i Atmospheric Pressure Limitati<strong>on</strong>


Pump Diagram<br />

Display<br />

Power Jack<br />

Accessory Jack<br />

AC Indicator<br />

Light<br />

Not used in this<br />

applicati<strong>on</strong><br />

(Do not place<br />

tubing in slot)<br />

Keypad<br />

<strong>Duodopa</strong>®<br />

Reservoir<br />

Battery<br />

Compartment<br />

Cassette Latch<br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

Fr<strong>on</strong>t<br />

View<br />

Power Jack<br />

symbol<br />

Accessory<br />

Jack symbol<br />

Rear<br />

View<br />

3<br />

General<br />

Descripti<strong>on</strong>


General<br />

Descripti<strong>on</strong><br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

Descripti<strong>on</strong> of the Keys, Display, and Features<br />

AC Indicator Light<br />

The green indicator light is <strong>on</strong> when you are using the AC adapter to<br />

power the pump.<br />

Display<br />

The Liquid Crystal Display (LCD) shows programming informati<strong>on</strong> and<br />

messages. In this manual, the term “display” is syn<strong>on</strong>ymous with display<br />

panel or LCD.<br />

Keypad<br />

The keys <strong>on</strong> the keypad are described below. A key beeps when pressed if<br />

it is operable in the current Lock Level.<br />

⁄ Used to start and stop pump delivery; silences alarms.<br />

¤ Used to enter (save) a new value in the pump’s memory when<br />

programming doses or pump settings or to clear values <strong>from</strong><br />

record-keeping screens. It is also used to return <strong>from</strong> the Biomed<br />

Functi<strong>on</strong>s to the Main Screen (Secti<strong>on</strong> 4).<br />

‹ Used to fill the tubing with <strong>Duodopa</strong>®.<br />

Œ<br />

„ Used to move <strong>from</strong> <strong>on</strong>e programming screen to the next without<br />

´ Used to “scroll up” or increase a value, or scroll through Biomed<br />

Î<br />

4<br />

Used to c<strong>on</strong>firm and deliver the “Morning Dose” (typically used as<br />

a daily loading dose) when the pump is running. When the pump is<br />

stopped, it is used to view or change the pump’s current Lock Level.<br />

Lock Levels are used to limit patient access to certain programming<br />

and operating functi<strong>on</strong>s. (See Lock Levels, this secti<strong>on</strong>.)<br />

changing the setting or value displayed; silences alarms.<br />

Functi<strong>on</strong> settings.<br />

Used to “scroll down” or decrease a value, or scroll through<br />

Biomed Functi<strong>on</strong> settings.


Å<br />

Í<br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

Used to put the pump into a low power state when not in use or<br />

back into full power.<br />

Used by the patient to deliver a programmed amount of<br />

medicati<strong>on</strong> up<strong>on</strong> request (Extra Dose).<br />

Power Jack<br />

You may plug an AC Adapter into the Power Jack as an alternate source<br />

of power. The indicator light <strong>on</strong> the fr<strong>on</strong>t of the pump will illuminate<br />

when the AC Adapter is in use.<br />

Accessory Jack<br />

The Accessory Jack is used for attaching a Remote Dose Cord for remote<br />

operati<strong>on</strong> of the Í key and for accessory cables. See the Instructi<strong>on</strong>s<br />

for Use supplied with those accessories.<br />

<strong>Duodopa</strong>® Reservoir<br />

The single-use reservoir is designed for use with the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>®<br />

<strong>Duodopa</strong>® pump. In this manual and <strong>on</strong> the pump’s display, the word<br />

“disposable” refers to the <strong>Duodopa</strong>® reservoir.<br />

Battery Compartment<br />

Two AA batteries fit into the battery compartment. The AA batteries<br />

serve as the primary source of power, or as a backup when an AC<br />

Adapter is in use.<br />

Cassette Latch<br />

The Cassette Latch attaches the cassette (the part of the <strong>Duodopa</strong>®<br />

reservoir that attaches to the pump) to the pump. This allows you to<br />

secure the cassette to the pump. If the cassette becomes unlatched while<br />

the pump is running, delivery will stop and an alarm will occur. If the<br />

cassette becomes unlatched while the pump is stopped, an alarm will<br />

occur.<br />

5<br />

General<br />

Descripti<strong>on</strong>


General<br />

Descripti<strong>on</strong><br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

Other Features Not Shown<br />

Upstream Occlusi<strong>on</strong> Sensor: The pump c<strong>on</strong>tains an upstream occlusi<strong>on</strong><br />

sensor. This feature may be turned <strong>on</strong> or off (see Secti<strong>on</strong> 4, Biomed<br />

Functi<strong>on</strong>s). When the sensor is turned <strong>on</strong>, and an occlusi<strong>on</strong> in the<br />

reservoir is detected, an alarm will sound, delivery will stop, and the<br />

display will show “Upstream Occlusi<strong>on</strong>.”<br />

CAUTION: When the Upstream Occlusi<strong>on</strong> Sensor is turned off, the<br />

pump will not detect occlusi<strong>on</strong>s in the reservoir. Periodically inspect<br />

the reservoir for decreasing volume. Undetected occlusi<strong>on</strong>s could<br />

result in under- or n<strong>on</strong>-delivery of <strong>Duodopa</strong>®.<br />

Downstream Occlusi<strong>on</strong> Sensor: The pump c<strong>on</strong>tains a downstream<br />

occlusi<strong>on</strong> sensor. When a downstream occlusi<strong>on</strong> (between the pump and<br />

the patient) is detected, an alarm will sound, delivery will stop, and the<br />

display will show “High Pressure.”<br />

Reservoir Volume Alarm: The Reservoir Volume Alarm indicates when<br />

the volume of <strong>Duodopa</strong>® in the reservoir is low or depleted. Each time<br />

you change the reservoir, you may reset the Reservoir Volume to the<br />

originally programmed volume. Then, as <strong>Duodopa</strong>® is delivered, the<br />

Reservoir Volume automatically decreases. When the pump calculates<br />

that 5 ml remain in the reservoir, beeps sound and “ResVol Low” appears<br />

<strong>on</strong> the Main Screen. This alarm recurs at every subsequent decrease of<br />

1 ml until the Reservoir Volume reaches 0 ml, at which point the pump<br />

stops and the Reservoir Volume empty alarm sounds.<br />

6


The Main Screen<br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

The Main Screen is the starting point for programming or viewing the<br />

pump’s settings.<br />

If no keys are pressed for 2 minutes, the display reverts to the Main<br />

Screen. When the two AA batteries are low, “LowBat” appears <strong>on</strong> the<br />

Main Screen.<br />

When running:<br />

Status of pump<br />

Reservoir Volume*<br />

* Does not appear <strong>on</strong> the Main Screen if Reservoir Volume is programmed<br />

to Not In Use.<br />

When stopped:<br />

Status of pump<br />

RUN LowBat<br />

ResVol 50.0 ml<br />

STOPPED<br />

Battery Status<br />

Status of Reservoir<br />

Volume*<br />

7<br />

General<br />

Descripti<strong>on</strong>


General<br />

Descripti<strong>on</strong><br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

Lock Levels<br />

Lock Levels are used to limit patient access to certain programming and<br />

operating functi<strong>on</strong>s. The table <strong>on</strong> the next page lists the functi<strong>on</strong>s that<br />

are accessible in Lock Level 0 (LL0), Lock Level 1 (LL1), and Lock Level 2<br />

(LL2). When a functi<strong>on</strong> is accessible, the key associated with the functi<strong>on</strong><br />

beeps when pressed. If a functi<strong>on</strong> is not accessible, the pump ignores<br />

the key press and a beep does not sound. Secti<strong>on</strong> 2, Pump Setup and<br />

Programming, describes how to change the Lock Level.<br />

Security Codes<br />

The following security codes are preset by the manufacturer for the<br />

clinician’s use:<br />

• The Lock Level Code, 14 (the first 2 digits of the pump’s model<br />

number), allows you to change the pump’s Lock Level.<br />

• The Biomed Functi<strong>on</strong>s Code, 114 (Lock Level Code + 100), allows<br />

access to the Biomed Functi<strong>on</strong>s. (See Secti<strong>on</strong> 4.)<br />

8<br />

WARNING: Do not disclose to the patient the pump’s security<br />

codes or any other informati<strong>on</strong> that would allow the patient<br />

complete access to all programming and operating functi<strong>on</strong>s.<br />

Improper programming could compromise patient treatment.


Lock Level Table<br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

This table lists the operati<strong>on</strong>s that are accessible in each Lock Level while<br />

the pump is stopped or running. LL0 permits complete access to all<br />

programming and operating functi<strong>on</strong>s. LL1 permits limited c<strong>on</strong>trol of<br />

pump programming and operati<strong>on</strong>s. LL2 permits <strong>on</strong>ly minimal c<strong>on</strong>trol<br />

of pump operati<strong>on</strong>s.<br />

Pump Operati<strong>on</strong>s<br />

and Programming<br />

Stopped Running<br />

LL0 LL1 LL2<br />

Any Lock<br />

Level<br />

Stop/Start the pump Yes Yes Yes Yes<br />

Reset Reservoir Volume Yes Yes Yes No<br />

Prime Yes Yes No No<br />

Change the Lock Level Yes, w/code Yes, w/code Yes, w/code No<br />

Change Morning Dose No No No Yes*<br />

Start an Extra Dose No No No Yes<br />

Start a Morning Dose No No No Yes<br />

Change C<strong>on</strong>tinuous Rate Yes<br />

Change Extra Dose Yes<br />

Up to LL0<br />

value<br />

Up to LL0<br />

value<br />

No No<br />

No No<br />

Clear Given amount Yes Yes No No<br />

Biomed Functi<strong>on</strong>s<br />

Access to Functi<strong>on</strong>s Yes, w/code No No No<br />

Extra Dose Lockout Yes, w/code No No No<br />

Morning Dose Lockout Yes, w/code No No No<br />

Upstream Occlusi<strong>on</strong><br />

Sensor On/Off<br />

Yes, w/code No No No<br />

* When in LL0, programming in the full range is possible. When in LL1,<br />

you can program up to the LL0 value. No programming is allowed in LL2.<br />

9<br />

General<br />

Descripti<strong>on</strong>


General<br />

Descripti<strong>on</strong><br />

Secti<strong>on</strong> 1: General Descripti<strong>on</strong><br />

10


2.0 Pump Setup and Programming<br />

Installing or Replacing the Batteries<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Use new, AA alkaline batteries such as DURACELL® or EVEREADY®<br />

ENERGIZER® batteries to power the pump. The pump retains all<br />

programmed values while the batteries are removed.<br />

Dispose of used batteries in an envir<strong>on</strong>mentally safe manner, and<br />

according to any regulati<strong>on</strong>s which may apply.<br />

WARNING:<br />

• Always have new batteries available for replacement. If power is<br />

lost, n<strong>on</strong>-delivery of <strong>Duodopa</strong>® will occur, which could compromise<br />

patient treatment.<br />

• If the pump is dropped or hit, the battery<br />

door or tabs may break. Do not use the pump<br />

if the battery door or tabs are damaged<br />

because the batteries will not be properly<br />

secured; this may result in loss of power<br />

and n<strong>on</strong>-delivery of <strong>Duodopa</strong>®, which could<br />

compromise patient treatment.<br />

CAUTION: Do not use rechargeable NiCd or nickel metal hydride<br />

(NiMH) batteries. Do not use carb<strong>on</strong> zinc (“heavy duty”) batteries.<br />

They do not provide sufficient power for the pump to operate properly.<br />

11<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

In order to install or replace the batteries, be sure the pump is Stopped.<br />

Then, follow these steps:<br />

12<br />

1. Push down and hold the arrow butt<strong>on</strong> while sliding the door off.<br />

2. Remove the used batteries. Pulling <strong>on</strong> the end of the battery strap<br />

will make battery removal easier.<br />

3. Install the new batteries in the compartment, making sure the<br />

battery strap is positi<strong>on</strong>ed correctly under the batteries.<br />

NOTE:<br />

• Be sure to match the polarity markings of the new batteries (+ and –)<br />

with those labeled in the battery compartment. If you put the batteries in<br />

backwards, the display panel will be blank, and you will not hear a beep.<br />

• Use 2 new, AA alkaline batteries to power the pump. You may<br />

use any alkaline batteries, including DURACELL® Alkaline and<br />

EVEREADY® ENERGIZER® Alkaline, for example.


Secti<strong>on</strong> 2: Pump Setup and Programming<br />

4. Place the battery door over the battery compartment and slide the<br />

door closed.<br />

5. Ensure that the door is latched by trying to remove the door<br />

without pressing the arrow butt<strong>on</strong>.<br />

NOTE: The power-up sequence will start, the pump will go through an<br />

electr<strong>on</strong>ic self-test, and the pump will beep 6 times at the end of the powerup<br />

sequence. All of the display indicators, the software revisi<strong>on</strong>, and each<br />

parameter will appear briefly.<br />

13<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

WARNING: If a gap is present anywhere between the battery door<br />

and the pump housing, the door is not properly latched. If the battery<br />

door becomes detached or loose, the batteries will not be properly<br />

secured; this could result in loss of power and n<strong>on</strong>-delivery of<br />

<strong>Duodopa</strong>®, which could compromise patient treatment.<br />

14


Secti<strong>on</strong> 2: Pump Setup and Programming<br />

6. Resume operati<strong>on</strong> of the current program by pressing and holding<br />

⁄ to start the pump or proceed to program the pump.<br />

NOTE:<br />

• The life of the batteries is dependent <strong>on</strong> the amount of <strong>Duodopa</strong>®<br />

delivered, delivery rate, battery age, and the temperature.<br />

• At the rate of 100 ml per day, alkaline batteries will usually last<br />

about 7 days.<br />

• The power of the batteries will be quickly depleted at temperatures<br />

below 10°C (50°F).<br />

CAUTION: Do not store the pump for prol<strong>on</strong>ged periods of time with<br />

the batteries installed. Battery leakage could damage the pump.<br />

15<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Watching Power Up<br />

When you install the batteries, the pump will start its power up sequence<br />

during which it performs self-tests and displays programmed values.<br />

Watch for the following:<br />

• Pump model number and last error code (“LEC”) if any, will appear.<br />

(If an error code appears, the pump should be removed <strong>from</strong> use and<br />

returned for service.)<br />

• The software revisi<strong>on</strong> will appear.<br />

• The display will turn <strong>on</strong>, showing a series of blocks. Look for any<br />

blank areas, which would indicate a faulty display.<br />

• The display will turn off briefly.<br />

• The pump’s program screens will appear, followed by the current<br />

Lock Level setting. The pump will beep after each screen. If messages<br />

appear, see the Messages and Alarms Table in Secti<strong>on</strong> 5 of this<br />

manual for further explanati<strong>on</strong> and instructi<strong>on</strong>.<br />

• When power up is complete, 6 beeps will sound, and the pump will be<br />

stopped <strong>on</strong> the Main Screen.<br />

16<br />

NOTE: To move quickly through the power-up screens, press „<br />

repeatedly. To skip the automatic review entirely, press Î. If you<br />

attempt to skip screens before the pump is powered up, it will not<br />

resp<strong>on</strong>d.


Changing to Lock Level 0 (LL0)<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Before programming the pump, make sure the pump is set to LL0.<br />

LL0 allows the clinician to access all programming and operating<br />

functi<strong>on</strong>s.<br />

1. Make sure the pump is stopped. Press Œ. The current Lock Level<br />

will appear. (If the Lock Level is already LL0, press „ to exit.)<br />

2. Press ´ or Î until “LL0” appears.<br />

3. Press Œ again or ¤. “Code 0” will appear.<br />

4. Press ´ or Î until the Lock Level Code “14” appears.<br />

5. Press Œ or ¤ to set the new Lock Level.<br />

WARNING: Do not disclose to the patient the pump’s security<br />

codes or any other informati<strong>on</strong> that would allow the patient<br />

complete access to all programming and operating functi<strong>on</strong>s.<br />

Improper programming could compromise patient treatment.<br />

17<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Programming the Pump: General Instructi<strong>on</strong>s<br />

The procedure for changing a programmed setting is similar for most<br />

programming screens.<br />

• Make sure the pump is stopped and in Lock Level 0.<br />

• To begin programming, start at the Main Screen and press „.<br />

• To change a setting, press ´ or Î until the desired setting<br />

appears. (Press and hold these keys to change values with increasing<br />

speed.)<br />

• Press ¤ within 25 sec<strong>on</strong>ds to c<strong>on</strong>firm a change or the screen will<br />

revert to the previous setting.<br />

• If any key other than ¤ is pressed, “Value not saved” will appear.<br />

Press „ to return to the screen being programmed, scroll to the<br />

desired value, and press ¤.<br />

• Press „ to advance to the next screen.<br />

• To leave a setting unchanged, press „ to go to the next screen.<br />

18


Delivery Methods<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

The CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump offers 3 methods of delivery:<br />

• C<strong>on</strong>tinuous Rate<br />

• Extra Dose<br />

• Morning Dose<br />

The following graph illustrates the combined delivery methods. The<br />

C<strong>on</strong>tinuous Rate, Extra Dose, and Morning Dose are programmed as<br />

described in this secti<strong>on</strong>. Ranges and programming increments are listed<br />

in the Specificati<strong>on</strong>s in Secti<strong>on</strong> 5.<br />

19<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Programming Screens<br />

These are the programming screens for the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>®<br />

pump. Descripti<strong>on</strong>s of the screens follow.<br />

20<br />

Reservoir Volume (ml)<br />

C<strong>on</strong>tinuous Rate (ml/hr)<br />

Extra Dose (ml)<br />

Given (ml)<br />

Reservoir Volume<br />

Reservoir Volume<br />

100.0 ml<br />

C<strong>on</strong>tinuous Rate<br />

5.0 ml/hr<br />

Extra Dose<br />

2.5 ml<br />

Given<br />

2.5 ml<br />

Enter the volume of medicati<strong>on</strong> c<strong>on</strong>tained in the filled <strong>Duodopa</strong>®<br />

reservoir. The Reservoir Volume value decreases as the pump delivers<br />

<strong>Duodopa</strong>® or as you prime the tubing. When you change the <strong>Duodopa</strong>®<br />

reservoir, reset the Reservoir Volume <strong>on</strong> this screen. If you do not wish to<br />

use the Reservoir Volume feature, scroll down to “Not In Use” (located<br />

before 1 and after 9999 in the range of values).<br />

NOTE: If the Reservoir Volume is programmed to “Not in Use,” the<br />

Upstream Occlusi<strong>on</strong> Sensor (if turned On in Biomed Functi<strong>on</strong>s) may<br />

indicate that the <strong>Duodopa</strong>® reservoir is nearly empty and needs to be<br />

replaced.<br />

The Reservoir Volume could be set higher than the capacity of the<br />

reservoir. Be sure to program the Reservoir Volume to reflect the actual<br />

volume in the reservoir.


C<strong>on</strong>tinuous Rate<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Enter the c<strong>on</strong>tinuous rate of <strong>Duodopa</strong>® delivery in ml/hr. The maximum<br />

rate is 20 ml/hr. If the prescripti<strong>on</strong> does not call for a C<strong>on</strong>tinuous Rate,<br />

enter zero.<br />

NOTE: If you intend to run the pump in Lock Level 1 so the C<strong>on</strong>tinuous<br />

Rate can be varied, you should enter the maximum allowable rate while<br />

programming in Lock Level 0. After programming, you may then change to<br />

Lock Level 1 and decrease the rate to its starting value. See Programming<br />

with Upper Limits, Adjusting Doses in LL1 at the end of Secti<strong>on</strong> 2.<br />

Extra Dose<br />

Enter the amount of <strong>Duodopa</strong>® to be delivered when the patient presses<br />

Í (or the butt<strong>on</strong> <strong>on</strong> the Remote Dose Cord, if attached). If the<br />

prescripti<strong>on</strong> does not call for an Extra Dose, enter zero.<br />

NOTE: If you intend to run the pump in Lock Level 1 so the Extra Dose<br />

can be varied, you should enter the maximum allowable dose while<br />

programming in Lock Level 0. After programming, you may then change to<br />

Lock Level 1 and decrease the dose to its starting value. See Programming<br />

with Upper Limits, Adjusting Doses in LL1 at the end of Secti<strong>on</strong> 2.<br />

Given<br />

This screen shows the total amount of <strong>Duodopa</strong>® delivered since the last<br />

time this value was cleared. The amount shown is rounded to the nearest<br />

0.05 ml. If this value reaches 99999.95, it automatically returns to 0 and<br />

c<strong>on</strong>tinues counting. The Given amount does not include the amount of<br />

<strong>Duodopa</strong>® used when priming the tubing.<br />

Other Programming <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g><br />

The Morning Dose should be programmed separately following<br />

programming of the above. <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> programming the Morning<br />

Dose can be found later in this secti<strong>on</strong>.<br />

21<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Programming Delivery<br />

WARNING: Programming the pump at a delivery rate other than<br />

what is prescribed will cause over- or under-delivery of <strong>Duodopa</strong>®,<br />

which could compromise patient treatment.<br />

To program the pump, enter the prescribed values.<br />

22<br />

1. Begin at the Main Screen.<br />

• Make sure the pump is in LL0.<br />

• Make sure STOPPED appears <strong>on</strong> the Main Screen.<br />

• Press „ to begin.<br />

2. Enter the Reservoir Volume.<br />

• Press ´ or Î to select the volume in the filled <strong>Duodopa</strong>®<br />

reservoir. (If you do not wish to use the Reservoir Volume<br />

feature, scroll down to “Not In Use” located before 1 or after<br />

9999.)<br />

• Press ¤.<br />

• Press „.<br />

3. Enter the C<strong>on</strong>tinuous Rate.<br />

• Press ´ or Î to select the desired C<strong>on</strong>tinuous Rate.<br />

• Press ¤.<br />

• Press „.<br />

4. Enter the Extra Dose amount.<br />

• Press ´ or Î to select the desired Extra Dose amount.<br />

• Press ¤.<br />

• Press „.<br />

NOTE: If required, program the Extra Dose Lockout time, as<br />

instructed in Secti<strong>on</strong> 4, Biomed Functi<strong>on</strong>s.<br />

5. Clear the amount Given.<br />

• Press ¤ if you wish to clear the amount Given.


• Press „.<br />

6. Review the program.<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Press „ repeatedly to review the programming screens. If you<br />

need to reprogram a setting, press „ until the appropriate<br />

screen appears and change the setting as described in this secti<strong>on</strong>.<br />

Programming a Morning Dose<br />

The pump must be running and a reservoir must be attached in order to<br />

program a Morning Dose.<br />

To program a Morning Dose<br />

1. Make sure the pump is running and in LL0 or LL1. Start the pump,<br />

if necessary.<br />

NOTE: In LL0, programming in the full range is possible. In LL1,<br />

you can program up to the LL0 value.<br />

2. Press Œ. The current Morning<br />

Dose value will appear.<br />

3. Press ´ or Î to select the<br />

desired Morning Dose value.<br />

Morning Dose<br />

5.0 ml<br />

4. Press ¤ to enter the value into<br />

the pump’s memory. (If desired,<br />

press Πagain to begin delivering the Morning Dose.)<br />

Once entered, the Morning Dose amount is retained in the pump’s<br />

memory. The patient can then press Πtwice to display and deliver the<br />

Morning Dose.<br />

NOTE: If required, program the Morning Dose Lockout time, as instructed<br />

in Secti<strong>on</strong> 4, Biomed Functi<strong>on</strong>s.<br />

23<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Removing a <strong>Duodopa</strong>® Reservoir<br />

WARNING: Clamp the fluid path tubing and/or disc<strong>on</strong>nect the<br />

tubing <strong>from</strong> the enteral access device before removing the <strong>Duodopa</strong>®<br />

reservoir <strong>from</strong> the pump to prevent unc<strong>on</strong>trolled delivery of<br />

<strong>Duodopa</strong>®, which could compromise patient treatment.<br />

To remove the <strong>Duodopa</strong>® reservoir <strong>from</strong> the pump<br />

24<br />

1. Stop the pump.<br />

2. Close the tubing clamp. If necessary, disc<strong>on</strong>nect the tubing <strong>from</strong><br />

the enteral access device.<br />

3. Insert a coin into the slot in the Cassette Latch and turn it<br />

clockwise. The latch will pop out when you unlock the cassette (the<br />

part of the <strong>Duodopa</strong>® reservoir that attaches to the bottom of the<br />

pump).<br />

4. A c<strong>on</strong>tinuous alarm will sound and the pump will display<br />

“No Disposable, Clamp Tubing” (the pump is not sensing proper<br />

cassette attachment). The alarm may be silenced by pressing ⁄<br />

or „.<br />

5. Remove the cassette hooks <strong>from</strong> the pump hinge pins.


Attaching a <strong>Duodopa</strong>® Reservoir<br />

Obtain a new, filled <strong>Duodopa</strong>® reservoir.<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

WARNING:<br />

• Use <strong>on</strong>ly <strong>Duodopa</strong>® reservoirs supplied by <strong>Abbott</strong> to maintain<br />

pump accuracy and assure proper pump operati<strong>on</strong>s.<br />

• Use <strong>on</strong>ly extensi<strong>on</strong> sets specified by <strong>Abbott</strong>, paying particular<br />

attenti<strong>on</strong> to all warnings and cauti<strong>on</strong>s associated with their use.<br />

DO NOT use extensi<strong>on</strong> sets with anti-siph<strong>on</strong> valves.<br />

After attaching the <strong>Duodopa</strong>® reservoir, proceed to the Reservoir Volume<br />

screen to reset the value for the volume, and then prime the tubing.<br />

To attach the <strong>Duodopa</strong>® reservoir to the pump<br />

1. Clamp the tubing.<br />

2. Insert the cassette hooks into the hinge<br />

pins <strong>on</strong> the pump.<br />

3. Place the pump upright <strong>on</strong> a firm, flat<br />

surface. Press down so the cassette (the<br />

part of the <strong>Duodopa</strong>® reservoir that<br />

attaches to the bottom of the pump) fits<br />

tightly against the pump.<br />

2001-01-15 D. Zurn<br />

«Lgc Attach Large Cass Coin»<br />

25<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

26<br />

4. Insert a coin into the slot in the<br />

Cassette Latch, push in, and turn<br />

counterclockwise until the line <strong>on</strong><br />

the latch lines up with the arrow<br />

<strong>on</strong> the side of the pump and you<br />

feel the latch click into place.<br />

2001-01-15 D. Zurn<br />

«Lgc Lock Coin Large Cass»<br />

WARNING: Attach the cassette (the part of the <strong>Duodopa</strong>® reservoir<br />

that attaches to the pump) properly. A detached or improperly<br />

attached cassette could result in unc<strong>on</strong>trolled delivery of <strong>Duodopa</strong>®,<br />

which could compromise patient treatment.<br />

5. Gently twist, push, and pull <strong>on</strong> the <strong>Duodopa</strong>® reservoir to make<br />

sure the cassette is firmly attached. If<br />

the cassette is not secure, repeat the<br />

procedure <strong>from</strong> step 1.<br />

1999-01-23 D. Zurn<br />

«Lgc Twist 50 ml»<br />

2001-01-15 D. Zurn<br />

«Lgc EMS Locked Side»


Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Priming the Tubing and C<strong>on</strong>necting to the Patient<br />

WARNING: Do not prime the fluid path with the tubing c<strong>on</strong>nected<br />

to a patient as this could result in over-delivery of <strong>Duodopa</strong>®, which<br />

could compromise patient treatment.<br />

The pump must be stopped and in LL0 or LL1 in order to prime the fluid<br />

path. If the pump is in LL2, you cannot prime the fluid path.<br />

NOTE: If you are not changing the <strong>Duodopa</strong>® reservoir but wish to prime the<br />

fluid path, you may follow the same procedure.<br />

1. Make sure the tubing is disc<strong>on</strong>nected <strong>from</strong> the patient’s enteral<br />

access device and the tubing clamp is open.<br />

2. Press and hold ‹. You will hear a single beep, and the word<br />

“Prime” and 3 sets of dashes, each accompanied by a beep, will<br />

appear <strong>on</strong> the display.<br />

3. After “Prime” and 3 sets of dashes ap pear, release ‹.<br />

4. Press and hold ‹ again to fill the fluid path. The screen displays<br />

“Priming . . .” and you will hear a short beep each time the pump<br />

goes through a delivery cycle.<br />

NOTE: <strong>Duodopa</strong>® delivered during priming is subtracted <strong>from</strong> the<br />

Reservoir Volume, but is not added to the Given screen since this<br />

amount is not delivered to the patient.<br />

5. If the tubing is not yet fully primed, press and hold ‹ again. If<br />

the tubing is primed, press „ to return to the Main Screen.<br />

NOTE: Each time you press and hold ‹, you pump a maximum<br />

of 1 ml of <strong>Duodopa</strong>® into the tubing. The pumping acti<strong>on</strong> will stop<br />

automatically when 1 ml has been delivered. If the fluid path is not<br />

fully primed, repeat the above priming procedure.<br />

6. C<strong>on</strong>nect the tubing to the patient’s enteral access device.<br />

7. Set the Lock Level for the patient as instructed in “Setting the Lock<br />

Level for the Patient”.<br />

27<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Setting the Lock Level for the Patient<br />

The Lock Level must be changed to LL1 or LL2 to prevent the patient <strong>from</strong><br />

having complete access to all programming and operating functi<strong>on</strong>s.<br />

NOTE: You may change the Lock Level at any time by stopping the pump<br />

and following the procedure below.<br />

To change the Lock Level<br />

28<br />

1. Press Œ. The current Lock Level will appear.<br />

2. Press ´ or Î until the desired Lock Level (LL1 or LL2)<br />

appears.<br />

3. Press Œ again or ¤. “Code 0” will appear.<br />

4. Press ´ or Î until the Lock Level Code “14” appears.<br />

5. Press Œ or ¤ to set the new Lock Level.<br />

WARNING: Do not disclose to the patient the pump’s security<br />

codes or any other informati<strong>on</strong> that would allow the patient<br />

complete access to all programming and operating functi<strong>on</strong>s.<br />

Improper programming could compromise patient treatment.


Secti<strong>on</strong> 2: Pump Setup and Programming<br />

Programming with Upper Limits, Adjusting Doses in<br />

Lock Level 1<br />

If a prescripti<strong>on</strong> allows for the C<strong>on</strong>tinuous Rate, Extra Dose, or Morning<br />

Dose to be adjusted during the course of therapy, you may wish to<br />

operate the pump in LL1. Then, when necessary, you can adjust values up<br />

to the maximum value that was programmed in LL0.<br />

Programming the pump to use this feature<br />

1. During initial programming in LL0, enter the upper limit values<br />

for the C<strong>on</strong>tinuous Rate, Extra Dose and/or Morning Dose. (These<br />

will be the maximum values when the pump is in LL1.)<br />

2. After you are finished programming, change the Lock Level to LL1.<br />

3. Decrease the C<strong>on</strong>tinuous Rate, Extra Dose and/or Morning Dose<br />

to its starting value, then press ¤.<br />

Adjusting the rate or doses while the pump is in use<br />

If it becomes necessary to increase or decrease the C<strong>on</strong>tinuous Rate and/<br />

or Extra Dose during the course of therapy, stop the pump but remain<br />

in LL1. To increase or decrease the Morning Dose, the pump must be in<br />

LL1, but it must remain running.<br />

1. To change the C<strong>on</strong>tinuous Rate or Extra Dose, press „ until the<br />

C<strong>on</strong>tinuous Rate or Extra Dose screen appears.<br />

To change the Morning Dose, press Œ.<br />

2. Press ´ or Î to select the desired value, then press ¤.<br />

NOTE: You will not be able to adjust the C<strong>on</strong>tinuous Rate, Extra Dose,<br />

or Morning Dose bey<strong>on</strong>d the value originally programmed in LL0.<br />

3. Restart the pump if appropriate.<br />

29<br />

Pump Setup<br />

& Programming


Pump Setup &<br />

Programming<br />

Secti<strong>on</strong> 2: Pump Setup and Programming<br />

30


3.0 Operating the Pump<br />

Starting the Pump<br />

Secti<strong>on</strong> 3: Operating the Pump<br />

When you start the pump, programmed values will be automatically<br />

reviewed. Then <strong>Duodopa</strong>® delivery will begin as programmed, and<br />

“RUN” will appear <strong>on</strong> the Main Screen. If the pump will not start, a<br />

message will appear <strong>on</strong> the display. Refer to the Messages and Alarms<br />

Table in Secti<strong>on</strong> 5.<br />

CAUTION: Prior to starting <strong>Duodopa</strong>® delivery, inspect the fluid<br />

path for kinks, a closed clamp, or other obstructi<strong>on</strong>. An undetected<br />

occlusi<strong>on</strong> may result in under- or n<strong>on</strong>-delivery of <strong>Duodopa</strong>® and/or<br />

nuisance alarms.<br />

To start the pump<br />

1. Press and hold ⁄.<br />

“Starting” and 3 sets of dashes appear <strong>on</strong> the display; then the<br />

dashes disappear <strong>on</strong>e-by-<strong>on</strong>e, each accompanied by a single beep.<br />

2. Release ⁄ after the last set of dashes disappears, and the pump<br />

beeps. All of the programming screens appear for your review <strong>on</strong>e<br />

after the other.<br />

Stopping the Pump<br />

Stopping the pump stops delivery. When the pump is stopped, STOPPED<br />

will appear <strong>on</strong> the Main Screen, and you will hear 3 beeps every 5 minutes.<br />

To stop the pump<br />

1. Press and hold ⁄.<br />

“Stopping” and 3 sets of dashes will appear <strong>on</strong>e-by-<strong>on</strong>e <strong>on</strong> the<br />

pump’s display, each accompanied by a single beep.<br />

2. Release ⁄ after the third set of dashes appears and the pump<br />

beeps.<br />

31<br />

Operating<br />

the Pump


Operating<br />

the Pump<br />

Secti<strong>on</strong> 3: Operating the Pump<br />

Turning the Pump On/Off<br />

When the pump is stopped, you may put the pump into a low power state<br />

by turning it off. The pump may be turned off when it is disc<strong>on</strong>nected <strong>from</strong><br />

the patient and it is going to be stored for short periods of time.<br />

CAUTION: Do not store the pump for prol<strong>on</strong>ged periods of time with<br />

the batteries installed. Battery leakage could damage the pump.<br />

To turn the pump off<br />

32<br />

1. Press and hold Å. “Turning Off” and 3 sets of dots will appear<br />

<strong>on</strong>e-by-<strong>on</strong>e <strong>on</strong> the pump’s display, each accompanied by a single<br />

beep.<br />

2. Release Å. The display turns off.<br />

To turn the pump <strong>on</strong><br />

1. Press and hold Å until the display turns <strong>on</strong>.<br />

2. Release Å. The pump will power up and automatically review all<br />

screens.


Starting a Morning Dose<br />

Secti<strong>on</strong> 3: Operating the Pump<br />

A Morning Dose may be delivered in any Lock Level while the pump is<br />

running. It allows you to deliver a specified amount of <strong>Duodopa</strong>®, as a<br />

loading dose for example.<br />

If the patient attempts to deliver a Morning Dose during the lockout<br />

time, the pump will not deliver the dose. The lockout time is determined<br />

by the value entered in Morning Dose Lockout, in Biomed Functi<strong>on</strong>s.<br />

The Extra Dose Lockout setting has no effect <strong>on</strong> Morning Dose<br />

frequency. A Morning Dose may be stopped in progress.<br />

NOTE: A Morning Dose cannot be started while an Extra Dose or another<br />

Morning Dose is in progress.<br />

To start a Morning Dose<br />

1. Make sure the pump is running (in any Lock Level). Start the<br />

pump if necessary.<br />

2. Press Œ.<br />

The current Morning Dose value (or the default value of 0 ml)<br />

will appear UNLESS the Morning Dose is currently locked out<br />

(in which case the screen will not appear). If the desired Morning<br />

Dose amount appears in the display, press Πagain to begin<br />

delivery.<br />

NOTE: If the desired Morning Dose amount does not appear in the<br />

display, program the desired Morning Dose amount as instructed in<br />

Secti<strong>on</strong> 2, Pump Setup and Programming.<br />

The screen will show the value decreasing as the Morning Dose is<br />

delivered.<br />

33<br />

Operating<br />

the Pump


Operating<br />

the Pump<br />

Secti<strong>on</strong> 3: Operating the Pump<br />

Starting an Extra Dose<br />

If an Extra Dose has been programmed, the patient may start an Extra<br />

Dose while the pump is running. The amount delivered is added to the<br />

amount provided by the C<strong>on</strong>tinuous Rate.<br />

If the patient attempts to deliver an Extra Dose during the lockout time,<br />

the pump will not deliver the dose. The lockout time is determined by the<br />

value entered in Extra Dose Lockout, in Biomed Functi<strong>on</strong>s.<br />

NOTE: An Extra Dose cannot be started while another Extra Dose or a<br />

Morning Dose is in progress.<br />

To start an Extra Dose<br />

34<br />

1. Make sure the pump is running (in any Lock Level). Start the<br />

pump if necessary.<br />

2. Press Í (or the butt<strong>on</strong> <strong>on</strong> the Remote Dose Cord, if attached).<br />

Two beeps will sound and the pump will begin delivering the Extra<br />

Dose.<br />

As the Extra Dose is delivered, the Main Screen will show “DOSE”<br />

in place of “RUN”.<br />

CAUTION: Do not use the Remote Dose Cord to pick up or carry the<br />

pump as damage to the pump or cord could result.<br />

Stopping an Extra Dose or Morning Dose<br />

An Extra Dose or Morning Dose can be stopped in progress. The pump<br />

may be in any Lock Level.<br />

To stop an Extra Dose or Morning Dose in progress<br />

• Press and hold ⁄ to stop the pump. All delivery is stopped,<br />

including the C<strong>on</strong>tinuous Rate. The remaining porti<strong>on</strong> of the Extra<br />

Dose or Morning Dose will be cancelled.


Resetting the Reservoir Volume<br />

Secti<strong>on</strong> 3: Operating the Pump<br />

To reset the Reservoir Volume to the value programmed in LL0, the<br />

pump may be in any Lock Level.<br />

1. Stop the pump.<br />

2. Press „ to display the Reservoir Volume screen.<br />

3. Press ¤ to reset the volume to the programmed value.<br />

35<br />

Operating<br />

the Pump


Operating<br />

the Pump<br />

Secti<strong>on</strong> 3: Operating the Pump<br />

36


4.0 Biomed Functi<strong>on</strong>s<br />

Secti<strong>on</strong> 4: Biomed Functi<strong>on</strong>s<br />

Overview: Accessing the Biomed Functi<strong>on</strong>s and<br />

Programming the Lockouts<br />

The Biomed Functi<strong>on</strong>s are pump c<strong>on</strong>figurati<strong>on</strong>s that are less frequently<br />

changed. The Biomed Functi<strong>on</strong>s are accessible <strong>on</strong>ly when the pump is<br />

stopped and in Lock Level 0.<br />

To Access the Biomed Functi<strong>on</strong>s<br />

1. Press Œ. The current Lock Level will appear.<br />

2. Press Œ or ¤. “Code 0” will appear.<br />

3. Press ´ or Î until the Biomed Functi<strong>on</strong>s Code “114” appears<br />

(Lock Level Code + 100). Then press Œ or ¤.<br />

WARNING: Do not disclose to the patient the pump’s security<br />

codes or any other informati<strong>on</strong> that would allow the patient<br />

complete access to all programming and operating functi<strong>on</strong>s.<br />

Improper programming could compromise patient treatment.<br />

4. Press „ to select the setting you wish to view or change, then<br />

follow the instructi<strong>on</strong>s in this secti<strong>on</strong> for the appropriate screen.<br />

NOTE: To leave a Biomed Functi<strong>on</strong> setting unchanged, press „.<br />

5 To exit the Biomed Functi<strong>on</strong>s, press „ until you get to the<br />

screen that reads, “NEXT for Biomed, ENTER for Main.”<br />

6. Press ¤ to return to the Main Screen.<br />

37<br />

Biomed<br />

Functi<strong>on</strong>s


Biomed<br />

Functi<strong>on</strong>s<br />

Secti<strong>on</strong> 4: Biomed Functi<strong>on</strong>s<br />

Extra Dose Lockout<br />

The Extra Dose Lockout time determines how often a patient can receive<br />

an Extra Dose of <strong>Duodopa</strong>®. The lockout time is the minimum amount<br />

of time that must elapse between the start of <strong>on</strong>e dose and the start of the<br />

next.<br />

To program an Extra Dose Lockout time<br />

38<br />

1. With the pump stopped and in LL0, access Biomed Functi<strong>on</strong>s.<br />

(Refer to the beginning of the Biomed Functi<strong>on</strong>s secti<strong>on</strong> for<br />

instructi<strong>on</strong>s <strong>on</strong> how to access Biomed Functi<strong>on</strong>s.)<br />

2. Press „ until “Extra Dose”<br />

appears.<br />

3. Press ´ or Î to scroll to the<br />

desired lockout time.<br />

4. Press ¤ to enter the value.<br />

Extra Dose<br />

01 hrs 00 min<br />

CAUTION: When you enter a new value, any lockout time in effect<br />

will be cleared. An Extra Dose could be requested and delivered<br />

immediately up<strong>on</strong> starting the pump, which may result in overdelivery<br />

of <strong>Duodopa</strong>®.


Morning Dose Lockout<br />

Secti<strong>on</strong> 4: Biomed Functi<strong>on</strong>s<br />

The Morning Dose Lockout time determines how often a patient can<br />

receive a Morning Dose. The lockout time is the minimum amount of<br />

time that must elapse between the start of <strong>on</strong>e dose and the start of the<br />

next.<br />

To program a Morning Dose Lockout time<br />

1. With the pump stopped and in LL0, access Biomed Functi<strong>on</strong>s.<br />

(Refer to the beginning of the Biomed Functi<strong>on</strong>s secti<strong>on</strong> for<br />

instructi<strong>on</strong>s <strong>on</strong> how to access Biomed Functi<strong>on</strong>s.)<br />

2. Press „ until “Morning Dose”<br />

appears.<br />

3. Press ´ or Î to scroll to the<br />

desired lockout time.<br />

4 Press ¤ to enter the value.<br />

Morning Dose<br />

20 hrs 00 min<br />

CAUTION: When you enter a new value, any lockout time in effect<br />

will be cleared. A Morning Dose could be requested and delivered<br />

immediately up<strong>on</strong> starting the pump, which may result in overdelivery<br />

of <strong>Duodopa</strong>®.<br />

39<br />

Biomed<br />

Functi<strong>on</strong>s


Biomed<br />

Functi<strong>on</strong>s<br />

Secti<strong>on</strong> 4: Biomed Functi<strong>on</strong>s<br />

Upstream Occlusi<strong>on</strong> Sensor On/Off<br />

The Upstream Occlusi<strong>on</strong> Sensor can be set to On or Off. If this screen<br />

is set to On, and an occlusi<strong>on</strong> in the reservoir is detected, an alarm<br />

will sound, delivery will stop, and the display will show “Upstream<br />

Occlusi<strong>on</strong>.”<br />

CAUTION: When the Upstream Occlusi<strong>on</strong> Sensor is turned off, the<br />

pump will not detect occlusi<strong>on</strong>s in the reservoir. Periodically inspect<br />

the reservoir for decreasing volume. Undetected occlusi<strong>on</strong>s could<br />

result in under- or n<strong>on</strong>-delivery of <strong>Duodopa</strong>®.<br />

40<br />

1. With the pump stopped and in LL0, access Biomed Functi<strong>on</strong>s.<br />

(Refer to the beginning of the Biomed Functi<strong>on</strong>s secti<strong>on</strong> for<br />

instructi<strong>on</strong>s <strong>on</strong> how to access Biomed Functi<strong>on</strong>s.)<br />

2. Press „ until “Upstream<br />

Sensor” appears.<br />

3. Press ´ or Î to select Off or<br />

On.<br />

4. Press ¤ to enter the change.<br />

Upstream Sensor<br />

Off


5.0 Reference<br />

Messages and Alarms, Alphabetical List<br />

Secti<strong>on</strong> 5: Reference<br />

Messages and Alarms Descripti<strong>on</strong> / Corrective Acti<strong>on</strong><br />

[No message]<br />

Two-T<strong>on</strong>e alarm<br />

[Screen displays<br />

current pump status]<br />

Two beeps (l<strong>on</strong>g-shorT)<br />

Battery Depleted<br />

Two-T<strong>on</strong>e alarm<br />

Battery Removed<br />

Pump w<strong>on</strong>’t run<br />

Two-T<strong>on</strong>e alarm<br />

With no AC adapter attached, the batteries have<br />

been removed while the pump is running.<br />

The pump is now stopped and unpowered.<br />

Install batteries to silence the alarm.<br />

OR<br />

Batteries were removed within approximately<br />

15 sec<strong>on</strong>ds after stopping the pump. Install<br />

new batteries to silence the alarm, if desired.<br />

Otherwise, the alarm will stop within a short<br />

period of time.<br />

The <strong>Duodopa</strong>® reservoir is not aligned with<br />

the pump or <strong>Duodopa</strong>® is not flowing <strong>from</strong><br />

the medicati<strong>on</strong> bag inside the <strong>Duodopa</strong>®<br />

reservoir to the pumping mechanism. Press<br />

⁄ or „ to silence the alarm. The pump<br />

c<strong>on</strong>tinues to run. Make sure the <strong>Duodopa</strong>®<br />

reservoir is properly aligned with the pump<br />

and <strong>Duodopa</strong>® is flowing <strong>from</strong> the medicati<strong>on</strong><br />

bag to the pumping mechanism. Very cold or<br />

extremely thick medicati<strong>on</strong> may cause this<br />

alarm as well. Allow the <strong>Duodopa</strong>® reservoir<br />

to thaw to room temperature before attaching<br />

to the pump.<br />

The battery power is too low to operate the<br />

pump. The pump is now stopped.<br />

• Change the batteries immediately.<br />

• Press and hold ⁄ to restart the pump.<br />

With the AC adapter attached, the AA<br />

batteries have been removed while the pump<br />

is running, or you have tried to start the<br />

pump with depleted batteries. The pump is<br />

now stopped. Press ⁄ or „ to silence<br />

the alarm. Reinstall batteries or install new<br />

batteries. Press and hold ⁄ to restart the<br />

pump.<br />

41<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Messages and Alarms Descripti<strong>on</strong> / Corrective Acti<strong>on</strong><br />

Error<br />

Two-T<strong>on</strong>e alarm<br />

High Pressure<br />

Two-T<strong>on</strong>e alarm<br />

Key pressed,<br />

Please release<br />

Two-T<strong>on</strong>e alarm<br />

LowBat<br />

Three Two-T<strong>on</strong>e beeps every 5 minuTes<br />

Motor Locked,<br />

remove all power<br />

Two-T<strong>on</strong>e alarm<br />

No Disposable,<br />

Clamp Tubing<br />

Two-T<strong>on</strong>e alarm<br />

No Disposable,<br />

Pump w<strong>on</strong>’t run<br />

Two-T<strong>on</strong>e alarm<br />

42<br />

An error has occurred. Remove the pump<br />

<strong>from</strong> use and c<strong>on</strong>tact Smiths Medical to<br />

return the pump for service.<br />

The pump has detected high pressure,<br />

which may be resulting <strong>from</strong> a downstream<br />

blockage, kink in the fluid path, or a closed<br />

clamp. Remove the occlusi<strong>on</strong> to resume<br />

operati<strong>on</strong>. Or, press ⁄ or „ to stop the<br />

pump and silence the alarm for 2 minutes,<br />

then remove the occlusi<strong>on</strong> and restart the<br />

pump.<br />

If a key is being pressed, stop pressing it. If<br />

the alarm persists, close the tubing clamp and<br />

remove the pump <strong>from</strong> use. C<strong>on</strong>tact Smiths<br />

Medical to return the pump for service.<br />

The batteries are low, but the pump is still<br />

operable.<br />

• Change the batteries so<strong>on</strong>.<br />

Batteries are depleted and the pump was<br />

powered up with the AC Adapter. Install new<br />

AA batteries, rec<strong>on</strong>nect the AC adapter, and<br />

restart the pump.<br />

The disposable (the <strong>Duodopa</strong>® reservoir)<br />

was removed. The pump is not sensing proper<br />

cassette attachment. Clamp the tubing or<br />

disc<strong>on</strong>nect <strong>from</strong> the enteral access device. A<br />

<strong>Duodopa</strong>® reservoir must be properly attached<br />

in order for the pump to run. Press ⁄ or<br />

„ to silence the alarm.<br />

You have tried to start the pump without a<br />

disposable (<strong>Duodopa</strong>® reservoir) attached.<br />

A <strong>Duodopa</strong>® reservoir must be properly<br />

attached in order for the pump to run. Press<br />

⁄ or „ to silence the alarm.


Secti<strong>on</strong> 5: Reference<br />

Messages and Alarms Descripti<strong>on</strong> / Corrective Acti<strong>on</strong><br />

Power lost while<br />

pump was <strong>on</strong><br />

Two-T<strong>on</strong>e alarm<br />

Programming Incomplete<br />

Two-T<strong>on</strong>e alarm<br />

when sTarTing The pump<br />

Remote Dose<br />

Cord Removed<br />

Two single beeps when pump sTopped;<br />

Two-T<strong>on</strong>e alarm when pump running<br />

Reservoir Volume<br />

Empty<br />

Two-T<strong>on</strong>e alarm<br />

RUN<br />

ResVol Low<br />

Three single beeps<br />

Service Due<br />

Two-T<strong>on</strong>e alarm<br />

Upstream Occlusi<strong>on</strong><br />

Two-T<strong>on</strong>e alarm<br />

The pump was running when power was<br />

removed. Stop the pump before changing the<br />

batteries or removing the power source. Press<br />

⁄ or „ to silence the alarm.<br />

A rate or dose must be programmed to start<br />

the pump. Press ⁄ or „ to silence the<br />

alarm.<br />

The remote dose cord was removed. Reinsert<br />

c<strong>on</strong>nector or press „ to silence the alarm.<br />

The Reservoir Volume has reached 0.0<br />

ml. Press ⁄ or „ to stop the alarm.<br />

Then install a new <strong>Duodopa</strong>® reservoir if<br />

appropriate and reset the Reservoir Volume.<br />

The Reservoir Volume is low. Change the<br />

<strong>Duodopa</strong>® reservoir so<strong>on</strong>. See Reservoir<br />

Volume alarm in Secti<strong>on</strong> 1 for further details.<br />

The pump is functi<strong>on</strong>al but is due for service<br />

based <strong>on</strong> clock battery age or total motor<br />

revoluti<strong>on</strong>s. This screen appears in LL0 for<br />

60 days and then in all Lock Levels until<br />

returned for service.<br />

If the Upstream Occlusi<strong>on</strong> Sensor is set to On<br />

and an occlusi<strong>on</strong> in the <strong>Duodopa</strong>® reservoir is<br />

detected, the Upstream Occlusi<strong>on</strong> alarm will<br />

sound. Press ⁄ or „ to stop the pump<br />

and silence the alarm for 2 minutes, then<br />

remove the occlusi<strong>on</strong> and restart the pump.<br />

You may have to detach the cassette <strong>from</strong> the<br />

pump, then reattach it.<br />

Value not saved A value was not saved by pressing ¤. Press<br />

„ to resume programming. Verify all<br />

programming screens before moving to the<br />

next screen or starting the pump.<br />

43<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Cleaning the Pump and Accessories<br />

CAUTION:<br />

• Do not immerse the pump in cleaning fluid or water. Do not allow<br />

soluti<strong>on</strong> to soak into the pump, accumulate <strong>on</strong> the keypad, or enter<br />

the battery compartment. Moisture buildup inside the pump may<br />

damage the pump.<br />

• Do not clean the pump with acet<strong>on</strong>e, other plastic solvents, or<br />

abrasive cleaners, as damage to the pump may occur.<br />

Routinely clean the pump to keep it free of dirt, liquids, and foreign<br />

objects.<br />

Use any of the following soluti<strong>on</strong>s to clean the pump and accessories:<br />

44<br />

• Soap soluti<strong>on</strong><br />

• Benzalk<strong>on</strong>ium Chloride c<strong>on</strong>centrate (0.13%)<br />

• Glutaral C<strong>on</strong>centrate, USP (2%)<br />

• 10% soluti<strong>on</strong> of household bleach (<strong>on</strong>e part household bleach to<br />

9 parts water)<br />

• Alcohol, USP (93%)<br />

• Isopropyl Alcohol, USP (99%)<br />

• Chlorohexidine (4%)<br />

• PDI — Super Sani-Cloth®<br />

• Mada Medical — MadaCide<br />

1. Dampen a soft, lint-free cloth with cleaning soluti<strong>on</strong> and wipe the<br />

exterior surface of the pump. Do not allow the soluti<strong>on</strong> to soak<br />

into the pump.<br />

2. Wipe the entire surface dry with another soft, lint-free cloth. Allow<br />

the pump to dry completely before use.


Cleaning the Battery C<strong>on</strong>tacts<br />

Secti<strong>on</strong> 5: Reference<br />

Routinely clean the battery c<strong>on</strong>tacts, possibly as part of the preventative<br />

maintenance cycle, to remove buildup of foreign material <strong>on</strong> the c<strong>on</strong>tacts.<br />

Use the following to clean the battery c<strong>on</strong>tacts:<br />

• Cott<strong>on</strong> swab wetted with Isopropyl Alcohol (70% minimum)<br />

NOTE: Do not use an alcohol formulati<strong>on</strong> that c<strong>on</strong>tains comp<strong>on</strong>ents<br />

other than alcohol and water.<br />

OR<br />

• Pre-moistened alcohol swab<br />

1. Using a swab wetted with alcohol, rub the entire battery c<strong>on</strong>tact<br />

for a minimum of 10 back and forth cycles (20 total wipes over the<br />

c<strong>on</strong>tact).<br />

2. Using a clean surface of the swab, repeat process for sec<strong>on</strong>d battery<br />

c<strong>on</strong>tact.<br />

3. Using a clean swab wetted with alcohol, rub each battery c<strong>on</strong>tact<br />

again, a minimum of 4 back and forth cycles (8 total wipes over the<br />

c<strong>on</strong>tact).<br />

4. Allow the c<strong>on</strong>tacts to dry completely before use.<br />

45<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Exposure to Radiati<strong>on</strong>, Magnetic Res<strong>on</strong>ance<br />

Imaging (MRI) or Use near ECG Equipment<br />

CAUTION:<br />

• Do not expose the pump to therapeutic levels of i<strong>on</strong>izing radiati<strong>on</strong><br />

as permanent damage to the pump’s electr<strong>on</strong>ic circuitry may<br />

occur. The best procedure to fol low is to remove the pump <strong>from</strong><br />

the patient during therapeutic radia ti<strong>on</strong> sessi<strong>on</strong>s. If the pump<br />

must remain in the vicinity during a ther apy sessi<strong>on</strong>, it should be<br />

shielded, and its ability to functi<strong>on</strong> properly should be c<strong>on</strong>firmed<br />

following treatment.<br />

• Do not use the pump in the vicinity of magnetic res<strong>on</strong>ance imaging<br />

(MRI) equipment as magnetic fields may adversely affect the<br />

operati<strong>on</strong> of the pump. Remove the pump <strong>from</strong> the patient during<br />

MRI procedures and keep it at a safe distance <strong>from</strong> magnetic<br />

energy.<br />

• This pump may interfere with ECG equipment. M<strong>on</strong>itor ECG<br />

equipment carefully when using this pump.<br />

46


C<strong>on</strong>tinuous Rate Scroll Ranges<br />

Secti<strong>on</strong> 5: Reference<br />

Starting<br />

Value Increment Maximum<br />

0.0 ml/hr 0.1 ml/hr 20.0 ml/hr<br />

Extra Dose, Morning Dose Scroll Ranges<br />

Extra Dose<br />

Increment max.<br />

0.1 ml 9.9 ml<br />

Morning Dose<br />

Increment max.<br />

0.1 ml 20 ml<br />

47<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Technical Descripti<strong>on</strong><br />

Standards used in Development of the Pump<br />

The following standards were used in whole or part in the development<br />

of the pump.<br />

Medical Electrical Equipment<br />

EN 60601-1 (1990), Medical Electrical Equipment, Part 1: General<br />

Requirements for Safety. Amendment A1 (1993) Amendment A13 (1996)<br />

Amendment A2 (1995).<br />

48<br />

EN 60601-1-2 (2001), Medical Electrical Equipment, Part 1-2: General<br />

Requirements for Safety – Collateral Standard: Electromagnetic<br />

Compatibility – Requirements and Tests.<br />

EN 60601-2-24 (1998), Medical Electrical Equipment, Part 2-24: Particular<br />

Requirements for Safety of Infusi<strong>on</strong> Pumps and C<strong>on</strong>trollers.<br />

EN 60601-1-4 (1996), Medical Electrical Equipment, Part 1-4: General<br />

Requirements for Safety – Collateral standard: Programmable electrical<br />

medical systems. Amendment A1: 1999.<br />

IEC 60601-1-1, (2nd Editi<strong>on</strong>, 1988) Medical Electrical Equipment, Part 1:<br />

General Requirements for Safety. Amendment 1 (1991) Amendment 2 (1995).<br />

IEC 60601-1-2, (Editi<strong>on</strong> 2.1, 2004-11), Medical Electrical Equipment,<br />

Part 1-2: General Requirements for Safety – Collateral Standard:<br />

Electromagnetic Compatibility – Requirements and Tests.<br />

IEC 60601-1-4, Medical Electrical Equipment, Part 1: General<br />

Requirements for Safety – Collateral standard: Programmable electrical<br />

medical systems.<br />

EN 980 (2003), Graphical symbols for use in the labeling of medical devices.<br />

Electromagnetic Compatibility<br />

IEC 61000-4-2 (2001), Electromagnetic Compatibility (EMC), Part 4:<br />

Testing and measurement techniques. Secti<strong>on</strong> 2: Electrostatic Discharge<br />

immunity test. Basic EMC Publicati<strong>on</strong>.<br />

IEC 61000-4-3 (2002), Electromagnetic Compatibility (EMC), Part<br />

4: Testing and measurement techniques. Secti<strong>on</strong> 3: Radiated, radio<br />

frequency, electromagnetic fields immunity test. Basic EMC Publicati<strong>on</strong>.<br />

Amendment 1 (1998-06).<br />

IEC 61000-4-8 (2001), Electromagnetic Compatibility (EMC), Part 4:<br />

Testing and measurement techniques. Secti<strong>on</strong> 8: Power frequency magnetic<br />

field immunity test, 1993.


Secti<strong>on</strong> 5: Reference<br />

RTCA/DO -160C, Radiated Emissi<strong>on</strong>s Only, Category A & Z Limit.<br />

CISPR11 (1990), Limits and methods of measurement of electromagnetic<br />

disturbance characteristics of industrial, scientific and medical (ISM) radio<br />

frequency equipment. Amendment 1 (1996) Amendment 2 (1996).<br />

CISPR14, Radiated and C<strong>on</strong>ducted Emissi<strong>on</strong>s, device powered by AC<br />

adapter <strong>on</strong>ly.<br />

CISPR14 (1993), Internati<strong>on</strong>al Special Committee <strong>on</strong> Radio Interference,<br />

limits and methods of measurement of radio interference characteristics<br />

of household electrical appliances, portable tools and similar electrical<br />

apparatus. Amendment 1 (1996).<br />

For CISPR11 and CISPR14 tests, the pump was fitted with an<br />

administrati<strong>on</strong> set with its inlet c<strong>on</strong>nected to a 250 ml bag and its outlet<br />

routed back to the bag forming a closed loop system. A total of 6 feet of<br />

tubing was used to form the closed loop.<br />

Specificati<strong>on</strong>s (Nominal)<br />

General Pump Specificati<strong>on</strong>s<br />

Resoluti<strong>on</strong> ...............................<strong>Duodopa</strong>® reservoir: 0.05 ml per pump<br />

activati<strong>on</strong> nominal<br />

Size ...........................................4.1 cm × 9.5 cm × 11.2 cm [1.6in.×3.8 in.×4.4 in.]<br />

excluding reservoir or other accessories<br />

Weight .....................................392 g [13.8 oz.] including 2 AA batteries,<br />

empty reservoir, excluding other accessories<br />

Classificati<strong>on</strong><br />

(IEC 60601-1) .........................CF J, Class II K<br />

Moisture Protecti<strong>on</strong> ..............Splashproof (E)<br />

Pump Alarms ............................Low battery power; depleted battery power;<br />

battery dislodged; pump stopped; pump<br />

fault; low reservoir volume; high pressure;<br />

disposable not attached when run attempted;<br />

motor locked; upstream occlusi<strong>on</strong>; reservoir<br />

volume empty; program incomplete; remote<br />

dose cord removed; key stuck; disposable<br />

detached.<br />

Maximum Infusi<strong>on</strong><br />

Pressure ...................................40.0 psi [2.76 bar]<br />

49<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

50<br />

Maximum Time to<br />

Occlusi<strong>on</strong> Alarm ...................7.0 hours.<br />

Bolus Volume at<br />

Occlu si<strong>on</strong> Alarm<br />

Pressure ...................................


Secti<strong>on</strong> 5: Reference<br />

* Therapy test used to determine System Delivery Accuracy: the system was<br />

programmed to deliver a 10 ml Morning Dose with 5 ml/hr C<strong>on</strong>tinuous<br />

Rate and three 3 ml Extra Doses, with a total of 100 ml of <strong>Duodopa</strong>®<br />

delivered. During the total infusi<strong>on</strong> time, the accuracy averages out (see<br />

Accuracy Test Results, this secti<strong>on</strong>).<br />

WARNING: System delivery accuracy of the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>®<br />

<strong>Duodopa</strong>® pump and attached <strong>Duodopa</strong>® reservoir is ± 10%. System<br />

delivery inaccuracies may occur as a result of back pressure or fluid<br />

resistance, which depends up<strong>on</strong> medicati<strong>on</strong> viscosity, catheter size,<br />

and extensi<strong>on</strong> set tubing. Failure to carefully c<strong>on</strong>sider this may<br />

compromise patient treatment.<br />

System Definiti<strong>on</strong> ..................System is defined as a CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>®<br />

<strong>Duodopa</strong>® pump with an attached<br />

<strong>Duodopa</strong>® reservoir<br />

High Pressure Alarm ............26 ± 14 psi [1.79 ± 0.97 bar]<br />

Bolus Accuracy at Set<br />

Value of 0.1 ml .......................± 10%<br />

Bolus Accuracy at Set<br />

Value of 9.9 ml .......................–17% to –8%<br />

Maximum Volume<br />

Infused under Single<br />

Fault C<strong>on</strong>diti<strong>on</strong> .....................0.2 ml<br />

Delivery Rate during<br />

priming ...................................Approx. 125 ml/hr<br />

51<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Delivery Specificati<strong>on</strong>s<br />

52<br />

Reservoir Volume ....................... 1 to 9999 ml or Not In Use; programmable in<br />

1 ml increments, displayed in 0.1 ml increments<br />

Default: Not In Use<br />

C<strong>on</strong>tinuous Rate ....................0 to 20 ml/hr in 0.1 ml/hr increments<br />

Default: 0.1 ml/hr<br />

Extra Dose ..............................0 to 9.9 ml in 0.1 ml increments<br />

Delivery rate (C<strong>on</strong>tinuous Rate + Extra<br />

Dose): 40 ml/hr nominal<br />

Default: 0 ml<br />

Given .......................................0 to 99999.95 ml in 0.05 ml increments<br />

Morning Dose ........................0.1 to 20.00 ml in 0.1 ml increments<br />

Delivery rate (C<strong>on</strong>tinuous Rate + Morning<br />

Dose): 40 ml/hr nominal<br />

Default: 0 ml<br />

Biomed Functi<strong>on</strong>s<br />

Extra Dose Lockout ................... 15 minutes to 24 hours in 15 minute increments<br />

Default: 1 hour<br />

Morning Dose Lockout ........1 to 24 hours in 1 hour increments<br />

Default: 20 hours<br />

Upstream Sensor ...................Off<br />

On<br />

Default: Off


Accuracy Test Results<br />

Secti<strong>on</strong> 5: Reference<br />

The following graphs are designed to show flow accuracy of the infusi<strong>on</strong><br />

system plotted against given time periods. The reservoir used for flow<br />

accuracy tests was supplied by <strong>Abbott</strong>.<br />

Flow rate immediately following startup<br />

Flow<br />

(ml/hr)<br />

Time Interval: 0.5 min<br />

Total Time: 120 min<br />

Programmed Rate: 20.0000 ml/hr<br />

Reservoir Used: <strong>Duodopa</strong>® reservoir<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

0 20 40 60 80 100<br />

Short term flow rate error<br />

% Error<br />

of Flow<br />

Programmed Rate: 20.0000 ml/hr<br />

Average Flow Rate: 19.7272 ml/hr<br />

Mean Flow Error: –1.36%<br />

Reservoir Used: <strong>Duodopa</strong>® reservoir<br />

5<br />

0<br />

-5<br />

-10<br />

-15<br />

-20<br />

-25<br />

Epmax<br />

Epmin<br />

D. Zurn 2000-12-20, «Graph Trumpet Duo short.eps»<br />

120<br />

T (min)<br />

-30<br />

0 2 5 11 19<br />

T (min)<br />

31<br />

53<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Flow rate immediately following startup<br />

Flow<br />

(ml/hr)<br />

54<br />

Time Interval: 15 min<br />

Total Time: 1545 min<br />

Programmed Rate: 0.1 ml/hr<br />

Reservoir Used: <strong>Duodopa</strong>® reservoir<br />

0.20<br />

0.15<br />

0.10<br />

0.05<br />

0.00 0 3 6 9 12 15 18 21 24<br />

T (hr)<br />

Short term flow rate error<br />

% Error<br />

of Flow<br />

Programmed Rate: 0.1 ml/hr<br />

Average Flow Rate: 0.1008 ml/hr<br />

Mean Flow Error: –0.83%<br />

Reservoir Used: <strong>Duodopa</strong>® reservoir<br />

56<br />

40<br />

24<br />

8<br />

-8<br />

-24<br />

-40<br />

Epmax<br />

Epmin<br />

-56<br />

0 60 150 330 570 T (min) 930


Secti<strong>on</strong> 5: Reference<br />

Electromagnetic emissi<strong>on</strong>s and immunity declarati<strong>on</strong>s<br />

Electromagnetic emissi<strong>on</strong>s declarati<strong>on</strong><br />

The Pump is intended for use in the electromagnetic envir<strong>on</strong>ment specified below. The<br />

customer or the user of the Pump should assure that it is used in such an envir<strong>on</strong>ment.<br />

Emissi<strong>on</strong>s test Compliance Electromagnetic envir<strong>on</strong>ment – guidance<br />

RF emissi<strong>on</strong>s<br />

CISPR 11<br />

RF emissioins<br />

CISPR 11<br />

Harm<strong>on</strong>ic emissi<strong>on</strong>s<br />

IEC 61000-3-2<br />

Voltage fluctuati<strong>on</strong>s/<br />

flicker emissi<strong>on</strong>s<br />

IEC 61000-3-3<br />

Compliance using:<br />

Group 1 The Pump uses RF energy <strong>on</strong>ly for its internal<br />

functi<strong>on</strong>. Therefore, its RF emissi<strong>on</strong>s are very<br />

low and are not likely to cause any interference<br />

in nearby electr<strong>on</strong>ic equipment.<br />

Class B The Pump is suitable for use in all establishments,<br />

including domestic establishments and<br />

those directly c<strong>on</strong>nected to the public low-<br />

Not applicable<br />

voltage power supply network that supplies<br />

buildings used for domestic purposes.<br />

Not applicable<br />

1. 100VAC/50HZ to 8VDC Power Adapter (JPN) with a cord length of 274 ±<br />

10 cm (108 ± 4 in).<br />

2. 230VAC/50HZ to 8VDC Desktop Power Adapter (EU) with a cord length of<br />

366 ± 20 cm (144 ± 8 in).<br />

3. 115VAC/60HZ to 8VDC Power Adapter (US) with a cord length of 274 ±<br />

10 cm (108 ± 4 in).<br />

4. 230VAC/50HZ to 8VDC Desktop Power Adapter (UK) with a cord length of<br />

366 ± 20 cm (144 ± 8 in).<br />

5. 230VAC/50HZ to 8VDC Desktop Power Adapter (AUS) with a cord length of<br />

366 ± 20 cm (144 ± 8 in).<br />

6. 230VAC/50HZ to 8VDC Power Adapter (AUS) with a cord length of 274 ±<br />

10 cm (108 ± 4 in).<br />

7. 230VAC/50HZ to 8VDC Power Adapter (UK) with a cord length of 274 ±<br />

10 cm (108 ± 4 in).<br />

8. 230VAC/50HZ to 8VDC Power Adapter (EU) with a cord length of 274 ±<br />

10 cm (108 ± 4 in).<br />

9. Remote Dose Cord with a length of 152 ± 5 cm (60 ± 2 in).<br />

WARNING: The use of Power Supplies and a Remote Dose Cord<br />

other than those listed in the Electromagnetic Emissi<strong>on</strong>s Declarati<strong>on</strong><br />

may result in increased emissi<strong>on</strong>s or decreased immunity of the Pump.<br />

55<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

56<br />

WARNING: The Pump should not be used adjacent to or stacked<br />

with other equipment. If adjacent or stacked use is necessary,<br />

the user should verify normal operati<strong>on</strong> of the pump in the<br />

c<strong>on</strong>figurati<strong>on</strong> in which it is to be used.<br />

Electromagnetic immunity declarati<strong>on</strong><br />

The Pump is intended for use in the electromagnetic envir<strong>on</strong>ment specified below. The<br />

customer or the user of the Pump should assure that it is used in such an envir<strong>on</strong>ment.<br />

Immunity test IEC 60601<br />

test level<br />

Electrostatic<br />

discharge (ESD)<br />

IEC 61000-4-2<br />

Electrical fast<br />

transient/burst<br />

IEC 61000-4-4<br />

Surge<br />

IEC 61000-4-5<br />

Voltage<br />

dips, short<br />

interrupti<strong>on</strong>s<br />

and voltage<br />

variati<strong>on</strong>s <strong>on</strong><br />

power supply<br />

input lines<br />

IEC 61000-4-11<br />

Power frequency<br />

50/60 Hz)<br />

magnetic field<br />

IEC 61000-4-8<br />

±8 kV c<strong>on</strong>tact<br />

±15 kV air<br />

±2 kV for<br />

power supply<br />

lines<br />

±1 kV for<br />

input/output<br />

lines<br />

±1 kV<br />

differential<br />

mode<br />

±2 kV<br />

comm<strong>on</strong><br />

mode<br />

95 % dip<br />

in UT) for<br />

0,5 cycle<br />

40 % UT<br />

(60 % dip in<br />

UT) for 5 cycles<br />

70 % UT<br />

(30 % dip in UT)<br />

for 25 cycles<br />

95 % dip in<br />

UT) for 5 sec<br />

Compliance<br />

level<br />

±8 kV c<strong>on</strong>tact<br />

±15 kV air<br />

±2 kV for<br />

power supply<br />

lines<br />

Not applicable<br />

±1 kV<br />

differential<br />

mode<br />

±2 kV<br />

comm<strong>on</strong><br />

mode<br />

95 % dip<br />

in UT) for<br />

0,5 cycle<br />

40 % UT<br />

(60 % dip in<br />

UT) for 5 cycles<br />

70 % UT<br />

(30 % dip in UT)<br />

for 25 cycles<br />

95 % dip in<br />

UT) for 5 sec<br />

3 A/m 400 A/m<br />

(IEC 60601-2-24)<br />

NOTE UT is the a.c. mains voltage prior to applicati<strong>on</strong> of the test level.<br />

Electromagnetic envir<strong>on</strong>ment –<br />

guidance<br />

Floors should be wood, c<strong>on</strong>crete or<br />

ceramic tile. If floors are covered with<br />

synthetic material, the relative humidity<br />

should be at least 30%.<br />

Mains power quality should be that<br />

of a typical commercial or hospital<br />

envir<strong>on</strong>ment.<br />

Mains power quality should be that<br />

of a typical commercial or hospital<br />

envir<strong>on</strong>ment.<br />

Mains power quality should be that<br />

of a typical commercial or hospital<br />

envir<strong>on</strong>ment. If the user of the Pump<br />

requires c<strong>on</strong>tinued operati<strong>on</strong> during<br />

power mains interrupti<strong>on</strong>s, it is recommended<br />

that the Pump be powered<br />

<strong>from</strong> an uninterruptible power supply<br />

or a battery.<br />

Power frequency magnetic fields<br />

should be at levels characteristic of a<br />

typical locati<strong>on</strong> in a typical commercial<br />

or hospital envir<strong>on</strong>ment.


Electromagnetic immunity declarati<strong>on</strong><br />

Secti<strong>on</strong> 5: Reference<br />

The Pump is intended for use in the electromagnetic envir<strong>on</strong>ment specified below. The<br />

customer or the user of the Pump should assure that it is used in such an envir<strong>on</strong>ment.<br />

Immunity test IEC 60601<br />

test level<br />

C<strong>on</strong>ducted RF<br />

IEC 61000-4-6<br />

Radiated RF<br />

IEC 61000-4-3<br />

3 Vrms<br />

150 kHz to<br />

80 MHz<br />

3 V/m<br />

80 MHz to<br />

2,5 GHz<br />

Compliance<br />

level<br />

Electromagnetic envir<strong>on</strong>ment –<br />

guidance<br />

Portable and mobile RF communicati<strong>on</strong>s<br />

equipment should be used no closer to<br />

any part of the Pump, including cables,<br />

than the recommended separati<strong>on</strong><br />

distance calculated <strong>from</strong> the equati<strong>on</strong><br />

applicable to the frequency of the<br />

transmitter.<br />

13 V Recommended separati<strong>on</strong> distance<br />

d=0.27*P 1/2<br />

13 V/m d=0.27*P 1/2 80MHz to 800 MHz<br />

d=0.54*P 1/2 800MHz to 2,5 GHz<br />

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.<br />

Where P is the maximum output power<br />

rating of the transmitter in watts (W) according<br />

to the transmitter manufacturer<br />

and d is the recommended separati<strong>on</strong><br />

distance in meters (m).<br />

Field strengths <strong>from</strong> fixed RF transmitters,<br />

as determined by an electromagnetic<br />

site survey, a should be less than<br />

the compliance level in each frequency<br />

range. b<br />

Interference may occur in the vicinity of<br />

equipment marked with the following<br />

symbol: R<br />

NOTE 2 These guidelines may not apply in all situati<strong>on</strong>s. Electromagnetic propagati<strong>on</strong> is affected<br />

by absorpti<strong>on</strong> and reflecti<strong>on</strong> <strong>from</strong> structures, objects and people.<br />

a Field strengths <strong>from</strong> fixed transmitters, such as base stati<strong>on</strong>s for radio (cellular/cordless) teleph<strong>on</strong>es<br />

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast<br />

cannot be predicted theoretically with accuracy. To assess the electromagnetic envir<strong>on</strong>ment due<br />

to fixed RF transmitters, an electromagnetic site survey should be c<strong>on</strong>sidered. If the measured<br />

field strength in the locati<strong>on</strong> in which the Pump is used exceeds the applicable RF compliance<br />

level above, the Pump should be observed to verify normal operati<strong>on</strong>. If abnormal performance<br />

is observed, additi<strong>on</strong>al measures may be necessary, such as reorienting or relocating the Pump.<br />

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 13 V/m.<br />

57<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Recommended separati<strong>on</strong> distances between portable and mobile RF<br />

communicati<strong>on</strong>s equipment and the Pump<br />

The Pump is intended for use in an electromagnetic envir<strong>on</strong>ment in which radiated RF<br />

disturbances are c<strong>on</strong>trolled. The customer or the user of the Pump can help prevent<br />

electromagnetic interference by maintaining a minimum distance between portable and<br />

mobile RF communicati<strong>on</strong>s equipment (transmitters) and the Pump as recommended<br />

below, according to the maximum output power of the communicati<strong>on</strong>s equipment.<br />

Rated maximum<br />

output power of<br />

transmitter<br />

W<br />

58<br />

Separati<strong>on</strong> distance according to frequency of transmitter<br />

m<br />

150 kHz to 80 MHz<br />

d=0.27*P 1/2<br />

80 MHz to 800 MHz<br />

d=0.27*P 1/2<br />

800 MHz to 2,5 GHz<br />

d=0.54*P 1/2<br />

0,01 0.03 0.03 0.05<br />

0,1 0.09 0.09 0.17<br />

1 0.27 0.27 0.54<br />

10 0.85 0.85 1.7<br />

100 2.7 2.7 5.4<br />

For transmitters rated at a maximum output power not listed above, the recommended<br />

separati<strong>on</strong> distance d in meters (m) can be determined using the equati<strong>on</strong> applicable to the<br />

frequency of the transmitter, where P is the maximum output power rating of the transmitter in<br />

watts (W) according to the transmitter manufacturer.<br />

NOTE 1 At 80 MHz and 800 MHz, the separati<strong>on</strong> distance for the higher frequency range applies.<br />

NOTE 2 These guidelines may not apply in all situati<strong>on</strong>s. Electromagnetic propagati<strong>on</strong> is affected<br />

by absorpti<strong>on</strong> and reflecti<strong>on</strong> <strong>from</strong> structures, objects and people.


Safety Features and Fault Detecti<strong>on</strong><br />

Hardware Safety Features<br />

Secti<strong>on</strong> 5: Reference<br />

Key hardware safety features include a watchdog timer circuit, motor<br />

driver and motor watchdog circuits, and a voltage detector circuit. Each<br />

safety circuit performs a unique functi<strong>on</strong> to insure the overall safety of<br />

the device.<br />

Watchdog Timer Circuit<br />

The microprocessor must send an appropriate signal to the watchdog<br />

circuit at least <strong>on</strong>ce per sec<strong>on</strong>d. If the microprocessor does not, the<br />

watchdog circuit will time out and shut down the pump c<strong>on</strong>troller.<br />

Watchdog timer circuitry is provided to m<strong>on</strong>itor the status of the<br />

microprocessor and disable the motor and enable the audible alarm if<br />

the microprocessor fails to functi<strong>on</strong> properly. The microprocessor must<br />

strobe the watchdog circuit at least <strong>on</strong>ce every sec<strong>on</strong>d in order to prevent<br />

the watchdog <strong>from</strong> performing its reset functi<strong>on</strong>. The reset output <strong>from</strong><br />

the watchdog circuit is a pulse output. This acts to “jump start” the<br />

microprocessor. This unique feature allows the microprocessor to test the<br />

watchdog circuit <strong>on</strong> every power-up.<br />

By setting a flag in the memory and not strobing the watchdog, the<br />

microprocessor can force a watchdog time-out. After being reset, the<br />

microprocessor checks the status flag to see if this was a time-out test.<br />

If so, the microprocessor c<strong>on</strong>tinues normal power-up activities. If<br />

the reset occurred when the microprocessor was not expecting it, the<br />

microprocessor traps the event, sounds the audible alarm and displays an<br />

error message <strong>on</strong> the LCD.<br />

Motor Driver/Motor Watchdog Circuit<br />

Motor drive circuitry is composed of a series of power FET transistors,<br />

passive comp<strong>on</strong>ents, and 2 voltage comparators. Built into the motor<br />

drive circuitry is an RC timer which times how l<strong>on</strong>g the motor runs<br />

each time it is turned <strong>on</strong>. If the motor runs for more than an average<br />

of 3 sec<strong>on</strong>ds, the circuit will time out and disable the motor. A unique<br />

feature of this circuit is that c<strong>on</strong>trol lines to and <strong>from</strong> the microprocessor<br />

circuit allow the microprocessor to perform a complete functi<strong>on</strong>al test of<br />

59<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

the motor drive circuit without running the motor. The microprocessor<br />

performs this test functi<strong>on</strong> every several minutes to assure its c<strong>on</strong>tinued<br />

functi<strong>on</strong>ality. An input <strong>from</strong> the watchdog circuit prevents motor<br />

operati<strong>on</strong> if the watchdog timer expires. The software verifies this<br />

functi<strong>on</strong> during the watchdog test described above.<br />

Voltage Detector Circuit<br />

Low voltage detecti<strong>on</strong> is performed by part of the Watchdog Circuit and<br />

by the microprocessor via software. Three low voltage levels are detected.<br />

The first 2 levels are detected by software and the third by hardware. The<br />

first level to be reached is the Low Battery Warning threshold, which<br />

occurs when the battery voltage decays to a nominal value of 2.4 volts<br />

when the motor is off or 1.8 volts when the motor is active. An Analog<br />

to Digital C<strong>on</strong>verter (ADC) built into the microprocessor allows the<br />

microprocessor, via software, to m<strong>on</strong>itor the battery voltage. At the Low<br />

Battery Warning threshold, the microprocessor enables a periodic series<br />

of beeps and displays a low battery warning message <strong>on</strong> the LCD. As<br />

the voltage operating the motor reaches a nominal value of 4.75 volts,<br />

the software disables delivery, places a battery depleted message <strong>on</strong> the<br />

LCD, and enables a c<strong>on</strong>stant two-t<strong>on</strong>e audible alarm. When the battery<br />

voltage decays to a nominal value of 1.0 volts, a hardware reset circuit<br />

is triggered which places the microprocessor in reset. This prevents<br />

ambiguous microprocessor operati<strong>on</strong> when the battery voltage c<strong>on</strong>tinues<br />

to decay. The hardware reset c<strong>on</strong>tinues until the battery is completely<br />

discharged or until it is removed. Once the pump c<strong>on</strong>troller goes into low<br />

battery shutdown, <strong>on</strong>ly replacing the depleted batteries with new <strong>on</strong>es<br />

will clear the c<strong>on</strong>diti<strong>on</strong>.<br />

60


Software Safety Features<br />

Hardware-related Software Safety Features<br />

Program Memory Check<br />

Secti<strong>on</strong> 5: Reference<br />

At power up and at regular intervals thereafter, the program memory is<br />

tested by calculating a Cyclic Redundancy Code (CRC) <strong>on</strong> the program<br />

and then comparing it with the CRC stored with the program.<br />

If the stored and calculated CRCs do not match, the software will display<br />

a system fault screen, turn <strong>on</strong> a c<strong>on</strong>tinuous two-t<strong>on</strong>e audible alarm, and<br />

stop all medicati<strong>on</strong> delivery.<br />

RAM Memory Check<br />

At power up, the random access memory is checked. A series of bit<br />

patterns is written to and read <strong>from</strong> each address in the RAM. If the read<br />

data is different <strong>from</strong> the written data, the software will display a system<br />

fault screen, turn <strong>on</strong> a c<strong>on</strong>tinuous two-t<strong>on</strong>e audible alarm, and stop all<br />

medicati<strong>on</strong> delivery.<br />

Motor Circuit Check<br />

At power up and at regular intervals thereafter, the motor circuit is<br />

checked to ensure that no power is being applied to the motor unless<br />

the motor is actually <strong>on</strong>. If the software detects power being applied to<br />

the motor at any other time, it will sound a c<strong>on</strong>tinuous two-t<strong>on</strong>e audible<br />

alarm and will no l<strong>on</strong>ger attempt to deliver medicati<strong>on</strong>. During every<br />

pump activati<strong>on</strong>, the software checks to see whether the motor completes<br />

<strong>on</strong>e activati<strong>on</strong>. If the motor fails to turn, or fails to complete a cycle, the<br />

software will display a system fault screen, turn <strong>on</strong> a c<strong>on</strong>tinuous twot<strong>on</strong>e<br />

audible alarm, and stop all medicati<strong>on</strong> delivery.<br />

Keyboard Encoder Check<br />

Every time the software receives data <strong>from</strong> the keyboard encoder, it is<br />

checked. If the data is not a valid key press, the software will disregard<br />

the key press. The keyboard is designed with redundant switches for<br />

‹, Í, and ⁄. The software must detect that both switches are<br />

activated before taking any acti<strong>on</strong>.<br />

61<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Data Handling Software Safety Features<br />

Data Stored in RAM<br />

Before use, data associated with delivery and stored in RAM is tested<br />

by calculating a CRC <strong>on</strong> the data and then comparing it with the CRC<br />

stored with the data. If the stored and calculated CRCs do not match, the<br />

software will display a system fault screen, turn <strong>on</strong> a c<strong>on</strong>tinuous twot<strong>on</strong>e<br />

audible alarm, and stop all medicati<strong>on</strong> delivery.<br />

Data Stored in EEPROM<br />

Before use, data associated with delivery and stored in EEPROM is tested<br />

by calculating a CRC <strong>on</strong> the data and then comparing it with the CRC<br />

stored with the data. If the stored and calculated CRCs do not match, the<br />

software will display a system fault screen, turn <strong>on</strong> a c<strong>on</strong>tinuous twot<strong>on</strong>e<br />

audible alarm, and stop all medicati<strong>on</strong> delivery.<br />

Data Stored in NOVRAM<br />

Before use, data associated with delivery and stored in NOVRAM is<br />

tested by calculating a CRC <strong>on</strong> the data and then comparing it with<br />

the CRC stored with the data. If the stored and calculated CRCs do<br />

not match, the software will display a system fault screen, turn <strong>on</strong> a<br />

c<strong>on</strong>tinuous two-t<strong>on</strong>e audible alarm, and stop all medicati<strong>on</strong> delivery.<br />

Data Used in Calculati<strong>on</strong>s<br />

Calculati<strong>on</strong>s <strong>on</strong> data used in some way to c<strong>on</strong>trol the delivery of<br />

medicati<strong>on</strong> are performed redundantly.<br />

The 2 calculated values are then compared. If the 2 values do not match,<br />

the software will display a system fault screen, turn <strong>on</strong> a c<strong>on</strong>tinuous twot<strong>on</strong>e<br />

audible alarm, and stop all medicati<strong>on</strong> delivery.<br />

Timer Data Registers<br />

The data in the Real Time Clock is checked at regular intervals. If the<br />

data is not reas<strong>on</strong>able, the software will turn <strong>on</strong> a c<strong>on</strong>tinuous two-t<strong>on</strong>e<br />

audible alarm and stop all medicati<strong>on</strong> delivery.<br />

62


Annual Functi<strong>on</strong>al Inspecti<strong>on</strong> and Testing<br />

Procedures<br />

Secti<strong>on</strong> 5: Reference<br />

Smiths Medical recommends annual functi<strong>on</strong>al inspecti<strong>on</strong>s and tests<br />

<strong>on</strong> the CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pump. C<strong>on</strong>tact Smiths Medical to<br />

coordinate return and inspecti<strong>on</strong> of the pump.<br />

CAUTION: CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>® <strong>Duodopa</strong>® pumps are sealed units. A<br />

broken or damaged seal will, therefore, be c<strong>on</strong>sidered c<strong>on</strong>clusive<br />

evidence that the pump has been misused and/or altered, which voids<br />

any and all warranties. All service and repair of CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>®<br />

<strong>Duodopa</strong>® pumps must be performed by Smiths Medical or its<br />

authorized agents.<br />

Collect Separately<br />

Z<br />

This product c<strong>on</strong>tains electr<strong>on</strong>ic and other comp<strong>on</strong>ents (such as batteries)<br />

that may c<strong>on</strong>tain materials which, if disposed of with general household<br />

waste, could be damaging to the envir<strong>on</strong>ment.<br />

In accordance with Directive 2002/96/EC Waste Electrical and Electr<strong>on</strong>ic<br />

Equipment, Smiths Medical requires that residents of the European Uni<strong>on</strong><br />

return this product for proper disposal at the end of it’s useful life.<br />

If you are unsure of the proper disposal method, c<strong>on</strong>tact your local<br />

distributor for specific disposal instructi<strong>on</strong>s.<br />

WARNING: There are potential health hazards associated with<br />

improper disposal of batteries, electr<strong>on</strong>ics, and c<strong>on</strong>taminated (used)<br />

reservoirs and extensi<strong>on</strong> sets. Dispose of used batteries, reservoirs,<br />

extensi<strong>on</strong> sets and other used accessories, or a pump that has reached<br />

the end of its useful life, in an envir<strong>on</strong>mentally safe manner, and<br />

according to any regulati<strong>on</strong>s that may apply.<br />

63<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

64<br />

Index<br />

Bold page numbers indicate figure<br />

references<br />

A<br />

Accessory Jack, 3, 5<br />

accuracy, 50<br />

accuracy tests, 53<br />

AC Adapter, 5, 50<br />

AC indicator light, 3, 4<br />

arrow keys, 4<br />

B<br />

batteries, AA, 5, 41, 42, 50<br />

installing, 11<br />

battery, internal clock, 43, 50<br />

battery compartment, 3, 5<br />

battery c<strong>on</strong>tacts, cleaning, 45<br />

battery life, 15, 50<br />

Biomed Functi<strong>on</strong>s, 9, 37<br />

Extra Dose Lockout, 9, 38<br />

Morning Dose Lockout, 9, 39<br />

specificati<strong>on</strong>s, 52<br />

Upstream Occlusi<strong>on</strong> Sensor On/<br />

Off, 9, 40<br />

Biomed Functi<strong>on</strong>s Code, 8, 37<br />

C<br />

Cassette Latch, 3, 5<br />

cleaning pump, accessories, 44<br />

C<strong>on</strong>tinuous Rate, 19, 21, 47, 52<br />

programming, 9, 22, 29<br />

D<br />

Downstream occlusi<strong>on</strong> sensor, 6<br />

<strong>Duodopa</strong>® reservoir, 3, 5<br />

attaching, 25-26<br />

removing, 24<br />

E<br />

ECG equipment, interference with,<br />

46<br />

Electromagnetic emissi<strong>on</strong>s and<br />

immunity declarati<strong>on</strong>s, 55-58<br />

Extra Dose, 19, 21, 47, 52<br />

programming, 9, 22, 29<br />

starting, 9, 34<br />

stopping, 34<br />

Extra Dose key, 5<br />

Extra Dose Lockout, 9, 38, 52<br />

Given, 21, 52<br />

clearing, 9, 22<br />

keypad, keys, 3, 4<br />

G<br />

K<br />

L<br />

Latch, Cassette, 3, 5<br />

Lock Level, 4, 8<br />

changing, 9, 17, 28<br />

Lock Level Code, 8, 17, 28<br />

M<br />

Magnetic Res<strong>on</strong>ance Imaging, 46<br />

Main Screen, 7<br />

Morning Dose, 19, 47, 52<br />

programming, 9, 23, 29<br />

starting, 9, 33<br />

stopping, 34<br />

Morning Dose Lockout, 9, 39, 52


P<br />

power-up, 16<br />

Power Jack, 3, 5<br />

priming, 9, 27<br />

programming, 22<br />

programming, general, 18<br />

programming screens, 20<br />

R<br />

radiati<strong>on</strong>, exposure to, 46<br />

Remote Dose Cord, 5, 21, 34<br />

Reservoir Volume, 6, 20, 27, 43, 52<br />

programming, 22<br />

resetting, 9, 35<br />

S<br />

safety features<br />

hardware, 59<br />

software, 61<br />

security codes<br />

Biomed Functi<strong>on</strong>s Code, 8, 37<br />

Lock Level Code, 8, 17, 28<br />

service due, 43<br />

software revisi<strong>on</strong>, 16<br />

specificati<strong>on</strong>s, 49<br />

Biomed Functi<strong>on</strong>s, 52<br />

delivery, 52<br />

general, 49<br />

standards, 48<br />

starting pump, 31<br />

stopping pump, 31<br />

system definiti<strong>on</strong>, 51<br />

T<br />

turning pump <strong>on</strong>/off, 32<br />

Secti<strong>on</strong> 5: Reference<br />

65<br />

Reference


Reference<br />

Secti<strong>on</strong> 5: Reference<br />

Limited Warranty<br />

Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original Purchaser that the<br />

infusi<strong>on</strong> pump (the “Pump”), not including accessories, shall be free <strong>from</strong> defects in materials and<br />

workmanship under normal use, if used in accordance with this Operator’s Manual, for a period<br />

of <strong>on</strong>e year <strong>from</strong> the actual date of sale to the Original Purchaser. THERE ARE NO OTHER<br />

WARRANTIES.<br />

This warranty does not cover normal wear and tear and maintenance items, and specifically<br />

excludes batteries, administrati<strong>on</strong> sets, extensi<strong>on</strong> sets or any other accessory items or equipment<br />

used with the Pump.<br />

Subject to the c<strong>on</strong>diti<strong>on</strong>s of and up<strong>on</strong> compliance with this Limited Warranty, the Manufacturer<br />

will repair or replace at its opti<strong>on</strong> without charge (except for a minimal charge for postage and<br />

handling) any Pump (not including accessories) which is defective if a claim is made during such<br />

<strong>on</strong>e-year period.<br />

The following c<strong>on</strong>diti<strong>on</strong>s, procedures, and limitati<strong>on</strong>s apply to the Manufacturer’s obligati<strong>on</strong><br />

under this warranty:<br />

A. Parties Covered by this Warranty: This warranty extends <strong>on</strong>ly to the Original Purchaser of<br />

the Pump. This warranty does not extend to subsequent purchasers. The Original Purchaser may<br />

be a patient, medical pers<strong>on</strong>nel, a hospital, or instituti<strong>on</strong> which purchases the Pump for treatment<br />

of patients. The Original Purchaser should retain the invoice or sales receipt as proof as to the<br />

actual date of purchase.<br />

B. Warranty Performance Procedure: Notice of the claimed defect must be made in writing or<br />

by teleph<strong>on</strong>e to the Manufacturer as follows: Smiths Medical ASD, Inc., 1265 Grey Fox Road,<br />

St. Paul MN 55112 USA, 1 800.258.5361, or Smiths Medical Internati<strong>on</strong>al Ltd., WD24 4LG UK,<br />

+44 (0)1923 246434. Notice to the Manufacturer must include date of purchase, model and serial<br />

number, and a descripti<strong>on</strong> of the claimed defect in sufficient detail to allow the Manufacturer<br />

to determine and facilitate any repairs which may be necessary. AUTHORIZATION MUST BE<br />

OBTAINED PRIOR TO RETURNING THE PUMP. If authorized, the Pump must be properly and<br />

carefully packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during<br />

shipment is at the risk of the sender.<br />

C. C<strong>on</strong>diti<strong>on</strong>s of Warranty: The warranty is void if the Pump has been 1) repaired by some<strong>on</strong>e<br />

other than the Manufacturer or its authorized agent; 2) altered so that its stability or reliability is<br />

affected; 3) misused; or, 4) damaged by negligence or accident. Misuse includes, but is not limited<br />

to, use not in compliance with the Operator’s Manual or use with n<strong>on</strong>approved accessories. The<br />

Pump is a sealed unit, and the fact that the seal has been broken will be c<strong>on</strong>sidered c<strong>on</strong>clusive<br />

evidence that the Pump has been altered or misused. Removal or damage to the Pump’s serial<br />

number will invalidate this warranty.<br />

D. Limitati<strong>on</strong>s and Exclusi<strong>on</strong>s: Repair or replacement of the Pump or any comp<strong>on</strong>ent part<br />

thereof is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusi<strong>on</strong>s and<br />

limitati<strong>on</strong>s shall apply:<br />

66<br />

1. No agent, representative, or employee of the Manufacturer has authority to bind the<br />

Manufacturer to any representati<strong>on</strong> or warranty, expressed or implied.<br />

2. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE<br />

PUMP FOR ANY PARTICULAR PURPOSE.


Secti<strong>on</strong> 5: Reference<br />

3. The Pump can <strong>on</strong>ly be used under the supervisi<strong>on</strong> of medical pers<strong>on</strong>nel whose skill and<br />

judgment determine the suitability of the Pump for any particular medical treatment.<br />

4. All recommendati<strong>on</strong>s, informati<strong>on</strong>, and descriptive literature supplied by the<br />

Manufacturer or its agents are believed to be accurate and reliable, but do not c<strong>on</strong>stitute<br />

warranties.<br />

E. Computer Program License:<br />

1. The Pump is intended to be used in c<strong>on</strong>juncti<strong>on</strong> with a particular Licensed Computer<br />

Program supplied by Manufacturer and use of any other program or unauthorized<br />

modificati<strong>on</strong> of a Licensed Computer Program shall void Manufac turer’s warranty as set forth<br />

above.<br />

2. The Original Purchaser and any users authorized by the Original Purchaser are hereby<br />

granted a n<strong>on</strong>exclusive, n<strong>on</strong>transferable license to use the Licensed Computer Program <strong>on</strong>ly<br />

in c<strong>on</strong>juncti<strong>on</strong> with the single Pump supplied by Manufacturer. The Licensed Computer<br />

Program is supplied <strong>on</strong>ly in machine-readable object code form and is based up<strong>on</strong><br />

Manufacturer’s proprietary c<strong>on</strong>fidential informati<strong>on</strong>. No rights are granted under this license<br />

or otherwise to decompile, produce humanly readable copies of, reverse engineer, modify or<br />

create any derivative works based up<strong>on</strong> the Licensed Computer Program.<br />

3. All other terms and c<strong>on</strong>diti<strong>on</strong>s of this Limited Warranty shall apply to the Licensed<br />

Computer Program.<br />

The Manufacturer disclaims resp<strong>on</strong>sibility for the suitability of the Pump for any particular<br />

medical treatment or for any medical complicati<strong>on</strong>s resulting <strong>from</strong> the use of the Pump. The<br />

Manufacturer shall not be resp<strong>on</strong>sible for any incidental damages or c<strong>on</strong>sequential damages to<br />

property, loss of profits, or loss of use caused by any defect or malfuncti<strong>on</strong> of the Pump.<br />

This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may<br />

have other legal rights which may vary <strong>from</strong> state to state.<br />

67<br />

Reference


CADD, CADD-<str<strong>on</strong>g>Legacy</str<strong>on</strong>g>, and the Smiths Medical design mark are trademarks of the Smiths<br />

Medical family of companies. The symbol ® indicates the trademark is registered in the<br />

U.S. Patent and Trademark Office and certain other countries.<br />

All other names and marks menti<strong>on</strong>ed are the trade names, trademarks or service marks<br />

of their respective owners.<br />

© 2010 Smiths Medical family of companies. All rights reserved.<br />

Smiths Medical ASD, Inc.<br />

St. Paul, MN 55112 USA<br />

1 800.258.5361 (USA),<br />

1 214.618.0218<br />

www.smiths-medical.com<br />

@<br />

Smiths Medical Internati<strong>on</strong>al Ltd.<br />

WD24 4LG, UK<br />

+44 (0)1923 246434<br />

2010-05<br />

40-5025-51H<br />

2<br />

s

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