Smiths Cadd-Legacy 1 Plus 6500 User manual

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OPERATOR’S MANUAL

™

CADD-Legacy

Ambulatory Infusion Pump

Model 6500

CONTINUOUS OR INTERMITTENT

DELIVERY

PLUS

This Operator’s Manual is for clinician use only.

Read the entire Operator’s Manual before

operating the pump.

SIMS DELTEC, INC.

This manual pertains only to the Deltec CADD-Legacy™ PLUS Model 6500 ambulatory infusion pump. This pump can be programmed to deliver medication at a continuous rate or to deliver a specified amount of drug at a set programmed interval. This manual is intended for clinician use only. Do not permit patients to have access to this manual. The pump has three security levels designed to limit patient access. Do not disclose the pump’s security codes or any other information that would allow inappropriate access to programming and operating functions.

The issue date of this Operator’s Manual is included on the back cover for the clinician’s information. In the event one year has elapsed between the issue date and product use, the clinician should contact SIMS Deltec, Inc. to see if a later revision of this manual is available.

Technical Assistance

If you have comments or questions concerning the operation of the CADD-Legacy™ pump, please call the appropriate number given below. When calling, please specify your pump’s software module. This information is located on the start-up screen.

Our staff at Deltec is available to help clinicians twenty-four hours a day with the programming and operation of the CADD-Legacy™ infusion system.

U.S. Distribution European Representative SIMS Deltec, Inc. SIMS Graseby Ltd. 1265 Grey Fox Road WD2 4LG UK St. Paul, Minnesota 55112 U.S.A. 1-800-426-2448 +44 (0) 1923 246434

CADD, Medication Cassette Reservoir design, CADD-Legacy, and Medication Cassette are SIMS trademarks. (The symbol ® indicates it is registered in the U.S. Patent and Trademark Office and certain other countries.)

DURACELL® is a registered trademark of DURACELL Inc. EVEREADY® ENERGIZER® is a registered trademark of Union Carbide Corp. Super Sani-Cloth® is a registered trademark of Professional Disposables, Inc.

The products described are covered by one or more of the following: U. S. Patent Nos. 4,559,038; 4,565,542; 4,650,469; 5,364,242; 5,531,697; 5,538,399; 5,540,561; 5,564,915; 5,567,119; 5,567,136; 5,647,854; 5,695,473; Japanese Patent No. 2034590; European Patent No. 0182502; other patent(s) pending, foreign patent(s) pending.

Read this entire Operator’s Manual before operating the CADD-Legacy

™

ambulatory infusion pump.

Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.

Warnings

• This Operator’s Manual should be used by clinicians only. Do not permit patients to have access to this manual, as the information contained would allow the patient complete access to all programming and operating functions. Improper programming could result in death or serious injury to the patient.

• For those patients who are likely to be adversely affected by unintended operations and failures, including interrupted medication or fluid delivery from the device, close supervision and provision for immediate corrective action should be provided.

• If the pump is used to deliver life-sustaining medication, an additional pump must be available.

• The pump is not to be used for delivery of blood or cellular blood products.

• If the pump is dropped or hit, inspect the pump for damage. Do not use a pump that is damaged or is not functioning properly. Contact Customer Service to return a pump for service.

• Use of a syringe with the CADD

Administration Set may result in UNDER-DELIVERY of medication. Syringe function can be adversely affected by variations in plunger dimension and lubricity, which can result in greater force required to move the syringe plunger. A syringe plunger will lose lubrication as it ages and, as a result, the amount of under-delivery will increase which could on occasion, be significant. Therefore, the type of medication and delivery accuracy required must be considered when using a syringe with the CADD® pump.

Clinicians must regularly compare the volume remaining in the

iii

syringe to the pump’s displayed values such as RES VOL and GIVEN in order to determine whether under-delivery of medication is occurring and if necessary, take appropriate action.

• System delivery inaccuracies may occur as a result of back pressure or fluid resistance, which depends upon drug viscosity, catheter size, and extension set tubing (for example, microbore tubing).

• Do not administer drugs to the epidural space or subarachnoid space unless the drug is indicated for administration to those spaces.

• To prevent infusion of drugs that are not indicated for epidural space or subarachnoid space infusion, do not use administration sets that incorporate injection sites.

• If a Medication Cassette

™

• When the Air Detector is turned off, the pump will not detect air in the fluid path. Periodically inspect the fluid path and remove any air to prevent air embolism.

• You must use a CADD

Extension Set with an Anti-Siphon Valve or a CADD® Administration Set with either an integral or Add On Anti-Siphon Valve to protect against unregulated gravity infusion that can result from an improperly attached cassette.

• When the Upstream Occlusion Sensor is turned off, the pump will not detect occlusions upstream (between pump and fluid container). Periodically inspect the fluid container for decreasing volume, inspect the fluid path for kinks, a closed clamp, or other upstream obstructions. Upstream occlusions could result in under- or non-delivery of medications.

• Do not disclose to the patient the pump’s security codes or any other information that would allow the patient complete access to all programming and operating functions.

• Do not use rechargeable NiCad or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (“heavy duty”) batteries. They do not provide sufficient power for the pump to operate properly.

• Always have new batteries available for replacement. If power is lost, non-delivery of drug will occur.

• If the pump is dropped or hit, the battery door tabs may break. Do not use the pump if the battery door or tabs are damaged because the batteries will not be properly secured; this may result in loss of power and non-delivery of drug.

• If a gap is present anywhere between the battery door and the pump housing, the door is not properly latched. If the battery door becomes detached or loose, the batteries will not be properly secured; this could result in loss of power and nondelivery of drug.

• Close the fluid path tubing with the clamp before removing the cassette from the pump to prevent unregulated gravity infusion.

• For detailed instructions and warnings pertaining to Medication

™

Cassette

Reservoir or CADD® Administration Sets, please refer

to the instructions supplied with those products.

• Frozen medication must be thawed at room temperature only. Do not heat the Medication Cassette

™

Reservoir in a microwave oven as this may damage the medication, the Medication Cassette™ Reservoir, or cause leakage.

™

• Attach the cassette (the part of the Medication Cassette

Reservoir or CADD® Administration Set that attaches to the pump) properly. An improperly attached or detached cassette could result in unregulated gravity infusion of medication from the fluid container or a reflux of blood.

• Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism.

• Ensure that the entire fluid path is free of all air bubbles before connecting to the patient to prevent air embolism.

• Prior to starting infusion, inspect the fluid path for kinks, a closed clamp, or other upstream obstructions, and remove any air to prevent air embolism.

Cautions

• Do not operate the pump at temperatures below +2°C (36°F) or above 40°C (104°F).

• Do not store the pump at temperatures below -20°C (-4°F) or above 60°C (140°F). Do not store the pump with the Medication Cassette the Protective Cassette provided.

• Do not expose the pump to humidity levels below 20% or above 90% relative humidity.

™

Reservoir or CADD® Administration Set attached. Use

• Do not store the pump for prolonged periods with the batteries installed.

• Do not immerse the pump in cleaning fluid or water or allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment.

• Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners.

• Do not expose the pump to therapeutic levels of ionizing radiation.

• Do not expose the pump directly to ultrasound.

• Do not use the pump in the vicinity of magnetic resonance imaging (MRI) equipment.

• Do not use the pump near ECG equipment.

• Do not sterilize the pump.

• Do not use the pump in the presence of flammable anesthetics or explosive gases.

• Use only Deltec accessories as using other brands may adversely affect the operation of the pump.

™

• CADD-Legacy

pumps are sealed units. A broken or damaged seal will, therefore, be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD-Legacy™ pumps must be performed by Deltec or its authorized agents.

• Check appropriate medication stability for time and temperature to assure stability with actual pump delivery conditions.

vii

viii

Table of Contents

Warnings iii Cautions vi

Section 1: General Description 1

Introduction ............................................................................... 1

Indications ................................................................................. 1

Epidural/Subarachnoid Administration ...................................... 1

Symbols ..................................................................................... 3

Pump Diagram ........................................................................... 4

Description of the Keys, Display, and Features .......................... 5

The Main Screen ........................................................................ 8

Lock Levels ................................................................................ 9

Security Codes ........................................................................... 9

Lock Level Table ....................................................................... 10

Section 2: Pump Setup and Programming 11

Installing or Replacing the Batteries ........................................... 11

Watching Power Up ................................................................... 16

Changing to Lock Level 0 (LL0) ............................................... 17

Programming the Pump: General Instructions ............................ 18

Delivery Methods ...................................................................... 19

Programming Screens for Continuous Delivery ......................... 20

Programming Continuous Delivery ........................................... 22

Programming Screens for Intermittent Delivery ........................ 24

Programming in the Intermittent Delivery Mode ....................... 28

Removing a Cassette .................................................................. 31

Attaching a Cassette .................................................................. 32

Priming the Tubing and Connecting to the Patient ..................... 34

Inserting the Tubing into the Air Detector ................................. 36

Setting the Lock Level for the Patient ......................................... 38

CDM: Programming with Upper Limits, Adjusting Rate in

Lock Level 1 ........................................................................... 39

IDM: Stopping the Pump During the Dose ................................ 40

Section 3: Operating the Pump 43

Starting the Pump ...................................................................... 43

Stopping the Pump ..................................................................... 43

Turning the Pump On/Off ......................................................... 44

Resetting Reservoir Volume ...................................................... 44

Section 4: Biomed Functions 45

Overview: Accessing the Biomed Functions ............................... 45

Air Detector On/Off .................................................................. 46

Upstream Sensor On/Off ............................................................ 47

Changing the Delivery Method .................................................. 48

Section 5: Reference 49

Messages and Alarms, Alphabetical List .................................... 49

Cleaning the Pump and Accessories ........................................... 53

Exposure to Radiation, Ultrasound, Magnetic Resonance

Imaging (MRI), or Use near ECG Equipment ......................... 55

Technical Description ................................................................ 56

Specifications (Nominal) ...................................................... 57

Accuracy Test Results .......................................................... 62

Safety Features and Fault Detection ..................................... 64

Software Safety Features ...................................................... 66

Data Handling Software Safety Features .............................. 67

Annual Functional Inspection and Testing Procedures ......... 68

Inspection Procedures .......................................................... 68

Testing Procedures ............................................................... 69

Occlusion Pressure Range Tests ........................................... 74

Accuracy Tests ..................................................................... 77

Index ......................................................................................... 82

Limited Warranty ...................................................................... 84

Section 1: General Description

1.0 General Description

Introduction

The CADD-Legacy™ PLUS ambulatory infusion pump provides measured drug therapy to patients in hospital or outpatient settings. Therapy should always be overseen by a physician or a certified, licensed healthcare professional. As appropriate to the situation, the patient should be instructed in using and troubleshooting the pump.

Indications

The CADD-Legacy™ PLUS pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous or intermittent rate of infusion.

Epidural/Subarachnoid Administration

The selected drug must be used in accordance with the indications included in the package insert accompanying the drug. Administration of any drug by this pump is limited by any warnings, precautions, or contraindications in the drug labeling.

Description

General

Analgesics

Administration of analgesics to the epidural space is limited to use with indwelling catheters specifically indicated for either short-or long-term drug delivery.

Administration of analgesics to the subarachnoid space is limited to use with indwelling catheters specifically indicated for short-term drug delivery.

Section 1: General Description

Anesthetics

Administration of anesthetics to the epidural space is limited to use with indwelling catheters specifically indicated for short-term drug delivery.

WARNING:

• Do not administer drugs to the epidural space or subarachnoid

General

Description

• To prevent the infusion of drugs that are not indicated for

• If a Medication Cassette

space unless the drug is indicated for administration to those spaces. Drugs not intended for epidural or subarachnoid space infusion could result in death or serious injury to the patient.

epidural space or subarachnoid space infusion, do not use administration sets that incorporate injection sites. The inadvertent use of injection sites for infusion of such drugs could result in death or serious injury to the patient.

™

Reservoir, CADD® Extension Set or CADD® Administration Set is used for drug delivery into the epidural or subarachnoid space, clearly differentiate them from those used for other routes of infusion, for example, by color coding, or other means of identification. Drugs not intended for epidural or subarachnoid space infusion could result in death or serious injury to the patient.

Symbols

~ Alternating Current (Power Jack)

Section 1: General Description

Accessory Jack

! Attention, consult accompanying documents

(read Instructions for Use)

K Class II Equipment

J Type CF Equipment

E Splashproof – water splashed against pump housing will

have no harmful effects (see Cleaning the Pump and Accessories, Section 5, for additional important information)

D Date of Manufacture

REF Catalog (reorder) number

SN Serial Number

Dispose of used batteries in an environmentally safe manner, and according to any regulations which may apply.

Description

General

Section 1: General Description

Pump Diagram

Accessory Jack

General

Description

Display

Power Jack

AC Indicator

Light

Air Detector

Front View

Keypad

Cassette

Threaded

Mounting

Hole

Battery

Compartment

Cassette Lock

Power Jack symbol

Accessory Jack symbol

Rear

View

Section 1: General Description

Description of the Keys, Display, and Features

AC Indicator Light

The green indicator light is on when you are using the AC adapter to power pump.

Display

The Liquid Crystal Display (LCD) shows programming information and messages. In this manual, the term “display” is synonymous with display panel or LCD.

Keypad

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

starts and stops pump delivery; silences alarms.

⁄

is used to enter (save) a new value in the pump’s memory

when programming pump settings or to clear values from record-keeping screens. It is also used to return from the Biomed Functions to the main screen (Section 4).

Description

General

is used to fill the tubing and to remove air bubbles from the

‹

fluid path.

is used to view or change the pump’s current lock level. Lock

levels are used to limit patient access to certain programming and operating functions. (See Lock Levels, this section.)

is used to move from one programming screen to the next

„

without changing the setting or value displayed; silences alarms.

allows you to “scroll up” or increase a value, or scroll

through Biomed Function settings.

allows you to “scroll down” or decrease a value, or scroll

through Biomed Function settings.

is used to put the pump into a low power state when not in

use or back into full power.

Section 1: General Description

Power Jack

You may plug an AC Adapter into the Power jack as an alternate source of power. The indicator light on the front of the pump will illuminate when the AC Adapter is in use.

Accessory Jack

This jack is used for accessory cables. See the Instructions for Use

General

supplied with those accessories.

Description

Air Detector

The Air Detector is on the pump in the area shown in the diagram. If air is detected in the part of the tubing that passes through the Air Detector, an alarm sounds and delivery stops. (See Section 5 for Air Detector specifications.) If an Air Detector is not required, it may be turned off. (See Section 4, Biomed Functions.)

WARNING: When the Air Detector is turned off, the pump will not detect air in the fluid path. Periodically inspect the fluid path and remove any air to prevent air embolism. Air embolism could result in death or serious injury to the patient.

Cassette

The cassette is the portion of the Medication Cassette™ Reservoir or CADD® Administration Set that attaches to the bottom of the pump. The following single-use products are compatible with the CADD-Legacy™ pump:

™

• Medication Cassette the CADD® Extension Set with Anti-Siphon Valve

• CADD

Administration Set with integral Anti-Siphon Valve

Administration Set with Add On Anti-Siphon Valve

WARNING: You must use a CADD® Extension Set with Anti-Siphon Valve or a CADD® Administration Set with either an integral or an Add On Anti-Siphon Valve to

Reservoir (50 or 100 ml), used with

Section 1: General Description

protect against unregulated gravity infusion that can result from an improperly attached cassette. Unregulated gravity infusion could result in death or serious injury to the patient.

Threaded Mounting Hole

The optional Polemount Bracket Adapter attaches to the threaded mounting hole in the back of the pump, allowing you to hang the pump on an IV pole.

Battery Compartment

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

Cassette Lock

This attaches the cassette (the part of the Medication Cassette Reservoir or CADD® Administration Set that attaches to the pump) to the pump. This allows you to secure the cassette to the pump. If the cassette becomes unlocked while the pump is running, delivery will stop and an alarm will occur. If the cassette becomes unlocked while the pump is stopped, an alarm will occur.

™

Description

General

Other Features Not Shown

Upstream Occlusion Sensor: The pump contains an upstream occlusion sensor. This feature may be turned on or off. (See Section 4, Biomed Functions.) When the sensor is turned on, and an upstream occlusion (between pump and fluid container) is detected, an alarm will sound, delivery will stop, and the display will show “Upstream Occlusion.”

WARNING: When the Upstream Occlusion Sensor is turned off, the pump will not detect occlusions upstream (between pump and fluid container). Periodically inspect the fluid container for decreasing volume, inspect the fluid path for kinks, a closed clamp, or other upstream obstructions. Upstream occlusions could result in under- or non-delivery of medications. If undetected, these

Section 1: General Description

occlusions could result in death or serious injury to the patient.

Downstream Occlusion Sensor: The pump contains a downstream

occlusion sensor. When a downstream occlusion (between the pump and patient access site) is detected, an alarm will sound, delivery will stop, and the display will show “High Pressure.”

General

Reservoir Volume Alarm: The Reservoir Volume alarm indicates

Description

when the fluid in the fluid container is low or depleted. Each time you change the fluid container, you may reset the Reservoir Volume to the originally programmed volume. Then, as medication is delivered, the Reservoir Volume automatically decreases. When the pump calculates that 5 ml remain in the fluid container, beeps sound and “ResVol Low” appears on the main screen. This alarm recurs at every subsequent decrease of 1 ml until the Reservoir Volume reaches 0 ml, at which point the pump stops and the Reservoir Volume empty alarm sounds.

The Main Screen

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

If no keys are pressed for a period of time (2 minutes), the display reverts to the main screen. When the two AA batteries are low, “LowBat” appears on the main screen.

Reservoir Volume

When running:

Status of pump

RUN LowBat ResVol 50.0 ml

Battery Status

Status of Reservoir Volume

When stopped:

Status of pump

STOPPED

Section 1: General Description

Lock Levels

Lock levels are used to limit patient access to certain programming and operating functions. The table on the next page lists the functions that are accessible in Lock Level 0 (LL0), Lock Level 1 (LL1), and Lock Level 2 (LL2). When a function is accessible, the key associated with the function beeps when pressed. If a function is not accessible, the pump ignores the key press and a beep does not sound. Section 2, Pump Setup and Programming, describes how to change the lock level.

Security Codes

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

• The Lock Level Code, 65 (the first two digits of the pump’s model number), allows you to change the pump’s lock level.

• The Biomed Functions Code, 165 (Lock Level Code + 100), allows access to the Biomed Functions. (See Section 4.)

Description

General

WARNING: Do not disclose to the patient the pump’s security codes or any other information that would allow the patient complete access to all programming and operating functions. Improper programming could result in death or serious injury to the patient.

Section 1: General Description

Lock Level Table

This table lists the operations that are accessible in each lock level while the pump is stopped and running. LL0 permits complete access to all programming and operating functions. LL1 permits limited control of pump programming and operations. LL2 permits only minimal control pump operations.

* Continuous Delivery Mode = CDM; Intermittent Delivery

General

Mode = IDM

Description

Pump Operations and Programming

Stop/Start the pump Yes Yes Yes Yes

Reset Reservoir Volume Yes Yes Yes

Prime Yes Yes

Change the lock level Yes, w/code Yes, w/code Yes, w/code

Change Continuous Rate Yes Up to LL0 value (CDM)*

Clear Given amount Yes Yes (CDM & IDM)*

Change Dose Volume Yes (IDM)*

Change Dose Duration Yes (IDM)*

Change Dose Cycle (IDM)* Yes

Change KVO Rate (IDM)* Yes

Change Dose Starts in Yes delay (IDM)*

Biomed Functions

Access to Functions Yes, w/code

Air Detector On/Off Yes, w/code View only View Only View Only

Upstream Occlusion Sensor On/Off Yes, w/code View only View Only View Only

Changing the Delivery Yes, w/code View only View Only View Only Mode

LL0 LL1 LL2

Stopped Running

Any

Lock Level

No No

No No No

Yes No No

No No No

Section 2: Pump Setup and Programming

2.0 Pump Setup and Programming

Installing or Replacing the Batteries

Use new, AA alkaline batteries such as DURACELL® or

EVEREADY

ENERGIZER® batteries. The pump retains all pro-

grammed values while the batteries are removed.

Dispose of used batteries in an environmentally safe manner, and according to any regulations which may apply.

WARNING:

• Do not use rechargeable NiCad or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (“heavy duty”) batteries. They do not provide sufficient power for the pump to operate properly, which could result in death or serious injury to the patient.

• Always have new batteries available for replacement. If power is lost, nondelivery of drug will occur and, depending on the type of drug being administered, could result in death or serious injury to the patient.

• If the pump is dropped or hit, the battery door or tabs may break. Do not use the pump if the battery door or tabs are damaged because the batteries will not be properly secured; this may result in loss of power, nondelivery of drug, and, depending on the type of drug being administered, death or serious injury to the patient.

Pump Setup &

Programming

Section 2: Pump Setup and Programming

In order to install or replace the batteries, be sure the pump is Stopped. Then, follow these steps:

1. Push down and hold the arrow button while sliding the

2. Remove the used batteries. Pulling on the end of the battery

Programming

Pump Setup &

3. Install the new batteries in the compartment, making sure

door off.

strap will make battery removal easier.

the battery strap is positioned correctly under the batteries.

NOTE:

• Be sure to match the polarity markings of the new batteries (+ and –) with those labeled in the battery compartment. If you put the batteries in backwards, the display panel will be blank, and you will not hear a beep.

Section 2: Pump Setup and Programming

• Use two new, AA alkaline batteries to power the pump. You may use any alkaline batteries, including DURACELL

Alkaline and EVEREADY® ENERGIZER® Alkaline, for example.

4. Place the battery door over the battery compartment and slide the door closed.

5. Ensure that the door is latched by trying to remove the door without pressing the arrow button.

NOTE: The power-up sequence will start, the pump will go through an electronic self-test, and the pump will beep six times at the end of the power-up sequence. All of the display indicators, the software revision level, and each parameter will appear briefly.

Pump Setup &

Programming

Section 2: Pump Setup and Programming

WARNING: If a gap is present anywhere between the battery door and the pump housing, the door is not properly latched. If the battery door becomes detached or loose, the batteries will not be properly secured; this could result in loss of power, nondelivery of drug, and, depending on the type of drug being administered, death or serious injury to the patient.

Programming

Pump Setup &

Section 2: Pump Setup and Programming

6. Resume operation of the current program by pressing and holding

to start the pump or proceed to program the

⁄

pump.

NOTE:

• The life of the batteries is dependent on the amount of medication delivered, delivery rate, battery age, and the temperature.

™

• At the rate of one 50 ml Medication Cassette

Reservoir per

day, alkaline batteries will usually last about seven days.

• The power of the batteries will be quickly depleted at temperatures below +10°C (50°F).

CAUTION: Do not store the pump for prolonged periods of time with the batteries installed. Battery leakage could damage the pump.

Pump Setup &

Programming

Section 2: Pump Setup and Programming

Watching Power Up

When you install the batteries, the pump will start its power up sequence during which it performs self-tests and displays programmed values. Watch for the following:

• Pump model number and last error code (“LEC”) if any,

will appear.

• The software version will appear.

• The display will turn on, showing a series of blocks. Look

for any blank areas, which would indicate a faulty display.

• The display will turn off briefly.

Programming

Pump Setup &

• The pump’s program screens will appear, followed by

• When power up is complete, six beeps will sound, and the

screens showing the Air Detector status, Upstream Occlusion sensor status, and lock level setting. The pump will beep after each screen. If messages appear, see the Messages and Alarms Table in Section 5 of this manual for further explanation and instruction.

pump will be stopped on the main screen.

NOTE: To move quickly through the power-up screens, press

„ repeatedly. To skip the automatic review entirely,

press powered up, it will not respond.

. If you attempt to skip screens before the pump is

Section 2: Pump Setup and Programming

Changing to Lock Level 0 (LL0)

Before programming the pump, make sure the pump is set to LL0. LL0 allows the clinician to access all programming and operating functions.

1. Make sure the pump is stopped. Press lock level will appear. (If the lock level is already LL0, press

to exit.)

„

2. Press

3. Press

4. Press

5. Press

´ or Î until “LL0” appears.

again or

. “Code 0” will appear.

´ or Î until the Lock Level Code “65” appears.

to set the new lock level.

. The current

Pump Setup &

Programming

Section 2: Pump Setup and Programming

Programming the Pump: General Instructions

The procedure for changing a programmed setting is similar for most programming screens.

• Make sure the pump is stopped and in Lock Level 0.

• To begin programming, start at the main screen and press .

„

• To change a setting, press

• Press

Programming

Pump Setup &

• If any key other than

• Press

• To leave a setting unchanged, press

or Î until the desired

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

within 25 seconds to confirm a change or the

screen will revert to the previous setting.

is pressed, “Value not saved”

will appear. Press grammed, scroll to the desired value, and press

to advance to the next screen.

„

screen.

to return to the screen being pro-

„

to go to the next

„

Section 2: Pump Setup and Programming

Delivery Methods

The CADD-Legacy™ PLUS pump has two delivery methods, and provides delivery in milliliters per hour:

• Continuous Delivery Mode (up to 125 ml per hour)

• Intermittent Delivery Mode (up to 125 ml per hour)

The Continuous Delivery Mode (CDM) permits a steady infusion rate. In this mode, you can program the pump to deliver medication at a constant rate in milliliters per hour.

Delivery

Rate (ml/hr)

Time

Pump Setup &

Programming

The Intermittent Delivery Mode (IDM) delivers a specified dose volume over a specified duration. You may repeat the dose in a cycle of up to 96 hours. The KVO feature allows you to deliver a minimal amount of drug between doses to maintain catheter patency. You may also delay the start of dose delivery using the “Dose Starts In” feature.

Cycle

Delay

Start

Period

Volume (ml)

KVO KVO

Time

Section 2: Pump Setup and Programming

Programming Screens for Continuous Delivery

These are the programming screens for the CADD-Legacy™ PLUS pump, in the continuous delivery mode. Descriptions of the screens follow.

Reservoir Volume

Continuous Rate (ml/hr)

Programming

Pump Setup &

Given

Air Detector (Off, On-High, or On-Low)

Upstream Sensor (Off or On)

Reservoir Volume

Enter the volume of fluid contained in a filled fluid container. The Reservoir Volume value decreases as the pump delivers fluid or as you use prime the tubing. When you change the fluid container, reset the reservoir volume on this screen. If you do not wish to use the Reservoir Volume feature, scroll down to “Not In Use” (located before 1 and after 9999 in the range of values).

Reservoir Volume

100.0 ml

Continuous Rate

5.0 ml/hr

Given

2.50 ml

Air Detector On-High

Upstream Sensor On

The residual volume could be set higher than the capacity of the fluid container. Be sure to program the reservoir volume to reflect the actual volume of the medication being used.

Section 2: Pump Setup and Programming

Continuous Rate

Enter the continuous rate of medication delivery (in ml/hr). The maximum rate is 125 ml/hr.

Given

This screen shows the total amount of drug delivered since the last time the value was cleared. The amount shown is rounded to the nearest 0.05 ml. If this value reaches 99999.95, it automatically returns to 0 and continues counting. The Given amount does not include drug used when priming the tubing.

Air Detector Status

This screen indicates whether the Air Detector is on high sensitivity, low sensitivity or turned off. The Air Detector status cannot be changed without entering the Biomed Functions Code (see Section 4, Biomed Functions, to change the setting).

Upstream Sensor Status

This screen indicates whether the Upstream Occlusion Sensor is turned on or turned off. The Upstream Sensor status cannot be changed without entering the Biomed Functions Code (see Section 4, Biomed Functions, to change the setting).

Pump Setup &

Programming

Before programming in Continuous Delivery Mode:

• Stop the pump and change the Lock Level to LL0 as described in Section 1.

• Select the Continuous Delivery Mode (CDM) as described in Changing the Delivery Methods in Section 4. If the pump is already in the CDM, you may select it again to clear all programming screens to their default settings.

Section 2: Pump Setup and Programming

Programming Continuous Delivery

Be sure the pump is in the continuous delivery mode versus the intermittent delivery mode. To program the pump, enter the prescribed values.

1. Begin at the main screen.

• Make sure the pump is in LL0.

• Make sure STOPPED appears on the main screen.

• Press

2. Enter the Reservoir Volume.

Programming

Pump Setup &

• Press

3. Enter the Continuous Rate.

• Press

4. Clear Given.

• Press

to begin.

„

or Î to select the volume of a filled fluid con-

tainer. (If you do not wish to use the Reservoir Volume feature, scroll down to “Not In Use” located before 1.)

„

or Î to select the desired rate.

„

if you wish to clear the amount given.

„

5. Verify the Air Detector status.

• Make sure the desired setting is displayed. This screen will show whether the Air Detector is turned on (high or low)

Section 2: Pump Setup and Programming

or off.

• If you need to change the Air Detector setting, see Section 4, Biomed Functions.

Pump Setup &

Programming

• Press

6. Verify the Upstream Sensor status.

• Make sure the desired setting is displayed. This screen will show whether the Upstream Occlusion Sensor is turned on or off.

• If you need to change the Upstream Occlusion Sensor setting, see Section 4, Biomed Functions.

• Press

7. Review the program.

„

Press need to reprogram a setting, press screen appears and change the setting as described in this section.

repeatedly to review the programming screens. If you

„

until the appropriate

„

Section 2: Pump Setup and Programming

Programming Screens for Intermittent Delivery

These are the programming screens for the CADD-Legacy™ PLUS pump, in the intermittent delivery mode. Descriptions of the screens follow.

Reservoir Volume

Dose Volume

Programming

Pump Setup &

Dose Duration

Dose Cycle

KVO Rate

Dose Remaining

Reservoir Volume

100.0 ml

Dose Volume

0.0 ml

Dose Duration 00 hrs 30 min

Dose Cycle 04 hrs 00 min

KVO Rate

0.0 ml/hr

Dose Remaining 00 hrs 15 min

Dose Starts in

Given

Dose Starts in 3 hrs 15 min

Given

2.50 ml

Section 2: Pump Setup and Programming

Air Detector (Off, On-High, or On-Low)

Upstream Sensor (Off or On)

Air Detector On-High

Upstream Sensor On

Reservoir Volume

Enter the volume of fluid contained in a filled fluid container. The Reservoir Volume value decreases as the pump delivers fluid or as you prime the tubing. When you change the fluid container, reset the reservoir volume on this screen. If you do not wish to use the Reservoir Volume feature, select “Not In Use” (located before 1 and after 9999 in the range of values).

The reservoir volume could be set higher than the capacity of the fluid container. Be sure to program the reservoir volume to reflect the actual volume of the medication being used.

Dose Volume

Enter the volume of the dose in milliliters. The maximum volume is 1000 ml. Entering a Dose Volume will automatically reset the cycle and set the time that the “Next Dose Starts in” to “Immediate.” If you enter a Dose Volume that would cause the rate to be greater than the maximum rate of 125 ml/hr, the pump will automatically lengthen the Dose Duration to accommodate the new volume. You will then need to confirm the new Dose Duration or enter a different duration. The cycle may also be affected if the Dose Duration is lengthened; in this case, you would also need to confirm the new Dose Cycle or enter a different Dose Cycle.

Pump Setup &

Programming

Dose Duration

Enter the duration for delivery of the dose, up to 24 hours. You will not be able to select a duration that would cause the rate of delivery of the programmed Dose Volume to exceed 125 ml/hr. Entering a Dose Duration will automatically reset the Dose Cycle and set the Dose Starts in to “Immediate.”

Section 2: Pump Setup and Programming

Dose Cycle

The cycle is the time from the start of one dose to the start of the next dose. The programmable values for cycle are based on the Dose Duration. There must be at least 5 minutes between the end of one dose and the start of the next; therefore, the minimum programmable cycle is the Dose Duration plus 5 minutes. The maximum cycle is 96 hours. Entering a cycle automatically sets the Next Dose Start Time to “Immediate.”

KVO Rate

The KVO or “Keep Vein Open” rate is optional. It allows the delivery of a drug to help maintain catheter patency. The programming range is 0 to 125 ml/hr. If the time the next Dose Starts in is programmed, the KVO rate is active during the initial delay. The KVO rate is also active between doses.

Programming

Pump Setup &

Dose Remaining

The Dose Remaining screen is displayed during dosing or if a dose was interrupted. This screen displays the time in hours and minutes that are required to infuse the remaining portion of the dose.

NOTE: If the dose is interrupted and the pump is stopped, both the Dose Remaining and “Dose Starts in” screens will be displayed. The “Dose Starts in” screen, shown with “— hrs — min,” allows the user to reset the time after which the dose should start.

Dose Starts in

The “Dose Starts in” screen allows you to delay the start of delivery up to four days by allowing you to select the amount of time after which the first dose should begin. The pump must be running after the selected delay in order for delivery to begin. If a delayed start is not desired, program the Dose Starts in to “Immediate” so that delivery will begin as soon as you start the pump.

The delay of the start of the next dose can be programmed in Lock Level 0 or Lock Level 1 at any time, but if a dose is in progress, this will cancel the remainder of the dose.

Section 2: Pump Setup and Programming

Given

This screen shows the total amount of drug delivered since the last time this value was cleared. The amount shown is rounded to the nearest 0.01 ml. If this value reaches 99999.95, it automatically returns to 0 and continues counting. The Given amount does not include drug delivered with the priming feature.

Air Detector

Upstream Sensor Status

Before programming in Intermittent Delivery Mode:

Pump Setup &

Programming

• Stop the pump and change the Lock Level to LL0 as described in Section 1.

• Select the Intermittent Delivery Mode (IDM) as described in Changing the Delivery Method in Section 4. If the pump is already in the IDM, you may select it again to clear all programming screens to their default settings.

Section 2: Pump Setup and Programming

Programming in the Intermittent Delivery Mode

Be sure the pump is in the intermittent delivery mode versus the continuous delivery mode. To program the pump, enter the prescribed values.

1. Begin at the main screen.

• Make sure the pump is in LL0.

• Make sure STOPPED appears on the main screen.

• Press

2. Enter the Reservoir Volume.

Programming

Pump Setup &

• Press

3. Enter the Dose Volume.

• Press

4. Enter the Dose Duration.

„ to begin.

´ or Î to select the volume of a filled fluid con-

tainer. (If you do not wish to use the Reservoir Volume feature, scroll down to “Not In Use” located before 1.)

¤.

„

´ or Î to select the desired volume.

„

NOTE: The maximum rate of the pump is 125 ml/hr. The pump will only allow a dose duration that will not cause a rate greater than 125 ml/hr for the programmed volume.

• Press

´ or Î to select the desired duration.

Section 2: Pump Setup and Programming

• Press

5. Enter the Dose Cycle.

• Press

6. Enter the KVO rate.

• Press

7. Acknowledge Dose Remaining (if applicable).

• Press

8. Enter a delay or “Immediate” for Dose Starts in _____ .

• Press the next dose (or “Immediate”).

„

´ or Î to select the desired cycle.

„

´ or Î to select the desired KVO rate.

„

´ or Î to select the desired amount of delay until

Pump Setup &

Programming

• Press

9. Clear Given.

• Press

10. Verify the Air Detector status.

• Make sure the desired setting is displayed. This screen will show whether the Air Detector is turned on (high or low) or off.

„

if you wish to clear the amount given.

„

Section 2: Pump Setup and Programming

• If you need to change the Air Detector setting, see Section 4, Biomed Functions.

• Press

11. Verify the Upstream Sensor status.

• Make sure the desired setting is displayed. This screen will

Programming

Pump Setup &

• If you need to change the Upstream Occlusion Sensor

• Press

12. Review the program.

„

show whether the Upstream Occlusion Sensor is turned on or off.

setting, see Section 4, Biomed Functions.

„

Press you need to reprogram a setting, press ate screen appears and change the setting as described in this section.

repeatedly to review the programming screens. If

„

until the appropri-

„

Section 2: Pump Setup and Programming

Removing a Cassette

WARNING: Close the fluid path tubing with the clamp before removing the cassette from the pump to prevent unregulated gravity infusion, which could result in death or serious injury to the patient.

1. Stop the pump.

2. Close the tubing clamp.

3. Insert a coin into the lock and turn it clockwise. The lock will pop out when you unlock the cassette.

4. A continuous alarm will sound and the pump will display “No Disposable, Clamp Tubing.” The alarm may be silenced by pressing

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

⁄

„

Pump Setup &

Programming

Section 2: Pump Setup and Programming

Attaching a Cassette

Obtain a new, filled Medication Cassette™ Reservoir, or CADD Administration Set attached to a non-vented, flexible IV bag.

WARNING: For detailed instructions and warnings pertaining to the Medication Cassette please refer to the instructions for use supplied with the product for preparing the product for use.

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

WARNING: Frozen medication must be thawed at room temperature only. Do not heat the Medication Cassette™ Reservoir in a

Programming

Pump Setup &

microwave oven as this may damage the medication, the Medication Cassette™ Reservoir, or cause leakage.

To attach the cassette to the pump

1. Clamp the tubing.

2. Insert the cassette hooks into the hinge pins on the pump.

3. Place the pump upright on a firm, flat surface. Press down

™

Reservoir or CADD® Administration Set,

so the cassette fits tightly against the pump.

1999-08-17 D. Zurn «Lgc Attach Cass Coin»

Section 2: Pump Setup and Programming

4. Insert a coin into the lock, push in, and turn counterclockwise until the line on the lock lines up with the arrow on the side of the pump and you feel the lock click into place.

WARNING: Attach the cassette (the part of the Medication Cassette™ Reservoir or CADD® Administration Set that attaches to the pump) properly. An improperly attached or detached cassette could result in unregulated gravity infusion of medication from the fluid container or a reflux of blood, which could result in death or serious injury to the patient.

You must use a CADD® Extension Set with Anti-Siphon Valve or a CADD® Administration Set with either an integral or an Add On Anti-Siphon Valve to protect against unregulated gravity infusion that can result from an improperly attached cassette.

Pump Setup &

Programming

5. Gently twist, push, and pull on the cassette to make sure it is firmly attached. If the cassette is not secure, repeat the procedure from step 1.

1999-01-23 D. Zurn «Lgc Twist 50 ml»

Section 2: Pump Setup and Programming

Priming the Tubing and Connecting to the Patient

The pump must stopped and in LL0 or LL1 in order to prime the fluid path. If the pump is in LL2, you cannot prime the fluid path.

NOTE: If you are not changing the fluid container but wish to prime the fluid path, you may follow the same procedure.

WARNING: Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism, which could result in death or serious injury to the patient.

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

Programming

Pump Setup &

the tubing clamp is open.

2. Press and hold word “Prime” will appear on the display.

3. After “Prime” and three sets of dashes appear, and you hear three beeps, release

4. Press and hold eliminate air bubbles. The screen displays “Priming . . .” and you will hear a short beep each time the pump goes through a delivery cycle.

NOTE:

• The air detector alarm is automatically disabled when

priming.

• Fluid delivered during priming is subtracted from the

Reservoir Volume, but is not added to the Given screen since this fluid is not delivered to the patient.

5. If the tubing is not yet fully primed, press and hold again. If the tubing is primed, press main screen.

. You will hear a single beep, and the

‹

again to fill the fluid path and to

‹

to return to the

„

‹

Section 2: Pump Setup and Programming

NOTE: Each time you press and hold maximum of 1.0 ml of fluid into the tubing. The pumping action will stop automatically when 1.0 ml has been delivered. If all of the air has not been removed from the fluid path, repeat the above priming procedure.

6. If the Air Detector is in use, go to the next section. If not, connect the tubing to the patient’s infusion set or indwelling catheter and go to Setting the Lock Level for the Patient.

WARNING: Ensure that the entire fluid path is free of all air bubbles before connecting to the patient to prevent air embolism. Air embolism could result in death or serious injury to the patient.

NOTE: If the fluid path contains an air eliminating filter, it is acceptable for air bubbles to be present on the vent side of the filter.

, you pump a

‹

Pump Setup &

Programming

Section 2: Pump Setup and Programming

Inserting the Tubing into the Air Detector

(See Section 4, Biomed Functions, for instructions on how to turn the air detector on and off.)

1. If the Air Detector is in use, make a small loop of tubing

2. Place the tubing over the groove in the air detector and tuck

Programming

Pump Setup &

underneath the air detector and hold it with your thumb.

it under the catch.

Catch

Section 2: Pump Setup and Programming

3. To seat the tubing into the groove, gently pull the tubing, until it is under the retention nubs and flat in the groove.

Retention

nubs

4. Connect the tubing to the patient’s infusion set or indwelling catheter.

WARNING: Ensure that the entire fluid path is free of all air bubbles before connecting to the patient to prevent air embolism. Air embolism could result in death or serious injury to the patient.

Pump Setup &

Programming

NOTE: If the fluid path contains an air eliminating filter, it is acceptable for air bubbles to be present on the vent side of the filter.

Section 2: Pump Setup and Programming

Setting the Lock Level for the Patient

The Lock Level must be changed to LL1 or LL2 to prevent the patient from having complete access to all programming and operating functions.

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

To change the lock level

1. Press

2. The current lock level will appear.

3. Press

Programming

Pump Setup &

4. Press

5. Press

6. Press

or Î until the desired lock level (LL1 or LL2)

appears.

again or

or Î until the Lock Level Code “65” appears.

. “Code 0” will appear.

to set the new lock level.

Section 2: Pump Setup and Programming

CDM: Programming with Upper Limits, Adjusting Rate in Lock Level 1

This feature may be used in the continuous delivery mode only. If a prescription allows for the Continuous Rate to be adjusted during the course of therapy, you may wish to operate the pump in LL1. Then, when necessary, you can adjust the Continuous Rate up to the maximum value that was programmed in LL0.

Programming the pump to use this feature

1. During initial programming in LL0, enter the upper limit value for the Continuous Rate. (This will be the maximum value when the pump is in LL1.)

2. After you are finished programming, change the lock level to LL1.

3. Decrease the Continuous Rate to its starting value, then press

Adjusting the rate while the pump is in use

If it becomes necessary to increase the Continuous Rate during the course of therapy, stop the pump but remain in LL1.

1. Press

2. Press

3. Restart the pump if appropriate.

until the Continuous Rate screen appears.

„

or Î to select the desired value, then press

Pump Setup &

Programming

Section 2: Pump Setup and Programming

IDM: Stopping the Pump During the Dose

Stopping the pump while a dose is in progress will shift all subsequent doses by the amount of time the pump is stopped.

Programming

Pump Setup &

If you wish to make up for the lost time in the cycle, it is recommended that you wait until the current dose is completed. If the

pump is stopped while a dose is infusing and you reprogram the “Dose Starts in” screen, then the pump will not deliver the remainder of that dose. (To determine the amount of time remaining in the current dose, use the Dose Remaining screen in the programming loop.) Then stop the pump, change to LL0 or LL1, and reprogram the delay on the “Dose Starts in” screen.

Resuming the Dose

Dose

Pump is

stopped

for 10

minutes

All

subsequent

doses shift by

10 minutes

Dose

KVOKVO

To resume delivery of a dose that has been stopped in progress, simply restart the pump.

Resetting the Cycle

If you wish to reset the cycle, stop the pump during KVO, change to LL0 or LL1, and reprogram the start of the Next Dose.

If a dose has been stopped in progress and you wish to cancel the current dose and reset the cycle, make sure the pump is in Lock

Section 2: Pump Setup and Programming

Level 0 or Lock Level 1. The Dose Remaining screen with the remaining hours and minutes of the dose will be displayed, followed by the “Dose Starts in” screen. Reprogram the “Dose Starts in” screen, which will cancel the remainder of the dose, and the next cycle will start after the delay you selected.

Stopping the pump during the KVO will not affect the start time of subsequent doses.

Pump Setup &

Programming

Section 2: Pump Setup and Programming

Programming

Pump Setup &

Section 3: Operating the Pump

3.0 Operating the Pump

Starting the Pump

When you start the pump, programmed values will be automatically reviewed. Then fluid delivery will begin as programmed, and “RUN” will appear on the main screen. If the pump will not start, a message will appear on the display. Refer to the Messages and Alarms Table in Section 5.

WARNING: Prior to starting infusion, inspect the fluid path for kinks, a closed clamp, or other upstream obstructions, and remove all air to prevent air embolism. An undetected upstream occlusion may result in under- or non-delivery of medication, and, depending upon the type of medication being delivered, could result in death or serious injury to the patient. Air embolism could result in death or serious injury to the patient.

To start the pump

Operating

the Pump

1. Press and hold

Three sets of dashes appear on the display; then they disappear one-by-one, each accompanied by a single beep.

2. Release pump beeps. All of the programming screens appear for your review one after the other.

after the last set of dashes disappears, and the

⁄

Stopping the Pump

Stopping the pump stops delivery. When the pump is stopped, STOPPED will appear on the main screen, and you will hear three beeps every 5 minutes.

To stop the pump

1. Press and hold

⁄

Section 3: Operating the Pump

Three sets of dashes will appear one-by-one on the pump’s display, each accompanied by a single beep.

2. Release pump beeps.

Turning the Pump On/Off

When the pump is stopped, you may put the pump into a low power state by turning it off. The pump may be turned off when it is disconnected from the patient and it is going to be stored for short periods of time.

CAUTION: Do not store the pump for prolonged periods of time with the batteries installed. Battery leakage could damage the pump.

To turn the pump off

• Press and hold

the Pump

Operating

Operating Instructions

To turn the pump on

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

after the third set of dashes appears and the

⁄

• Press and hold matically review all screens.

. The pump will power up and auto-

Resetting Reservoir Volume

To reset the Reservoir Volume to the value programmed in LL0, the pump may be in any lock level.

1. Stop the pump.

2. Press

3. Press

to display the Reservoir Volume screen.

„

to reset the volume to the programmed value.

Section 4: Biomed Functions

4.0 Biomed Functions

Overview: Accessing the Biomed Functions

The Biomed Functions are pump configurations that are less frequently changed. The Biomed Functions are accessible only when the pump is stopped and in Lock Level 0.

To Access the Biomed Functions

1. Press

2. Press

3. Press appears (Lock Level Code + 100). Then press

4. Press then follow the instructions in this section for the appropriate screen.

NOTE: To leave a Biomed Function unchanged, press

5. To exit the Biomed Functions, press the screen that reads, “NEXT for Biomed, ENTER for main.”

6. Press

. The current lock level will appear.

or Î until the Biomed Functions Code “165”

. “Code 0” will appear.

to select the setting you wish to view or change,

„

until you get to

„

to return to the main screen.

„

Functions

Biomed

Section 4: Biomed Functions

Air Detector On/Off

The Air Detector screen can be set to On-High, On-Low, or Off.

1. With the pump stopped and in LL0, access Biomed Functions. (Refer to the beginning of the Biomed Functions section for instructions on how to access Biomed Functions.)

Biomed

Functions

2. Press

3. Use

• On-high is the highest sensitivity, where the smallest

bubbles will be detected.

• On-low is lower sensitivity, where only the larger bubbles

will be detected. See Specifications in Section 5.

4. Press

5. Press

until “Air Detector” appears.

„

or Î to select On-High, On-Low, or Off.

to enter the change.

to go to the next screen.

„

Section 4: Biomed Functions

Upstream Sensor On/Off

The Upstream Occlusion Sensor screen can be set to On or Off. If this screen is set to On, and an upstream occlusion (between pump and fluid container) is detected, an alarm will sound, delivery will stop, and the display will show “Upstream Occlusion.”

1. With the pump stopped and in LL0, access Biomed Functions. (Refer to the beginning of the Biomed Functions section for instructions on how to access Biomed Functions.)

2. Press

3. Press

4. Press

until “Upstream Sensor” appears.

„

or Î to select Off or On.

to enter the change.

Functions

Biomed

Section 4: Biomed Functions

Changing the Delivery Method

Delivery can be changed between Continuous Delivery and Intermittent Delivery. This allows for either continuous drug delivery or infusion of a prescribed volume of a drug over a specified time period. When the delivery method is changed, programming will revert to default settings.

1. With the pump stopped and in LL0, access Biomed Functions. (Refer to the beginning of the Biomed Functions section for instructions on how to access Biomed Functions.)

Biomed

Functions

2. Press

3. Press

4. Press

until “Delivery Mode” appears.

„

or Î to select “Continuous” or “Intermittent.”

to enter the change.

Section 5: Reference

5.0 Reference

Messages and Alarms, Alphabetical List

Messages and Alarms Description / Corrective Action

Air In Line Detected

TWO-TONE ALARM

Battery Depleted

TWO-TONE ALARM

Battery Removed Pump won’t run

TWO-TONE ALARM

The Air Detector has detected air in the fluid path; the fluid path may contain air bubbles, or the tubing may not be fully threaded through the Air Detector. Press

or „ to silence the alarm, then:

⁄

• Make sure the tubing is threaded properly.

• If the fluid path contains air bubbles, close the clamps and disconnect the fluid path from the patient. Then follow the instructions for removing air by priming the pump, described in Section 2. Restart the pump.

The battery power is too low to operate the pump. The pump is now stopped.

• Change the batteries immediately.

• Press and hold ⁄ to restart the pump.

With the AC adapter attached, the AA batteries have been removed while the pump is running, or you have tried to start the pump with depleted batteries. The pump is now stopped. Press ⁄ or

to silence the alarm. Reinstall

„

batteries or install new batteries. Press and hold ⁄ to restart the pump.

Reference

Section 5: Reference

Messages and Alarms Description / Corrective Action

[No message]

TWO-TONE ALARM

Error

TWO-TONE ALARM

High Pressure

TWO-TONE ALARM

With no AC adapter attached, the batteries have been removed while the pump is running. The pump is now stopped and unpowered. Install batteries to silence the alarm.

Batteries were removed within approximately 15 seconds after stopping the pump. Install new batteries to silence the alarm, if desired. Otherwise, the alarm will stop within a short period of time.

An error has occurred. Remove the pump from service and contact Customer Service to return the pump for service.

The pump has detected high pressure, which may be resulting from a downstream blockage, kink in the fluid path, or a closed tubing clamp. Remove the obstruction to resume operation. Or, press „ or ⁄ to stop the pump and silence the alarm for 2 minutes, then remove the obstruction and restart the pump.

Key pressed, Please release

TWO-TONE ALARM

Reference

LowBat

THREE TWO-TONE BEEPS EVERY 5 MINUTES

If a key is being pressed, stop pressing it. If the alarm persists, close the tubing clamp and remove the pump from use. Contact Customer Service to return the pump for service.

The batteries are low, but the pump is still operable.

• Change the batteries soon.

Section 5: Reference

Messages and Alarms Description / Corrective Action

Motor Locked, remove all power

TWO-TONE ALARM

No Disposable, clamp tubing

TWO-TONE ALARM

No Disposable, Pump won’t run

TWO-TONE ALARM

Power lost while pump was on

TWO-TONE ALARM

Batteries are depleted and the pump was powered up with the AC Adapter. Install new AA batteries, reconnect the AC adapter, and restart the pump.

The disposable (CADD® Administration Set or Medication Cassette™ Reservoir) was removed. Clamp the tubing immediately. A CADD® Administration Set or Medication Cassette™ Reservoir must be properly attached in order for the pump to run. Press ⁄ or „ to silence the alarm.

You have tried to start the pump without a disposable (CADD® Administration Set or Medication Cassette™ Reservoir) attached. A CADD® Administration Set or Medication Cassette™ Reservoir must be properly attached in order for the pump to run. Press ⁄ or „ to silence the alarm.

The pump was on and running when power was removed. Stop the pump before changing the battery or removing the power source. Press ⁄ or „ to silence the alarm.

Reference

Programming Incomplete

TWO-TONE ALARM WHEN

THE PUMP

STARTING

Reservoir Volume Empty

TWO-TONE ALARM

A rate or dose must be programmed to start the pump. Press ⁄ or „ to silence the alarm.

The Reservoir Volume has reached

0.0 ml. Press ⁄ or „ to stop the alarm. Then install a new fluid container if appropriate and reset the reservoir volume.

Section 5: Reference

Messages and Alarms Description / Corrective Action

RUN ResVol Low

THREE SINGLE BEEPS

Service Due

TWO-TONE ALARM

Upstream Occlusion

TWO-TONE ALARM

Value not saved

The Reservoir Volume is low. Change the fluid container soon. See Reservoir Volume Alarm in Section 1 for more information.

Service is due for this pump based on clock battery age or total motor revolutions. This screen will appear while in LL0 only for 60 days and then in all lock levels until returned for service.

Fluid is not flowing from the fluid container to the pump. Check for a kink in the tubing or a closed clamp between the fluid container and pump. Press or ⁄ to stop the pump and silence the alarm for 2 minutes, then remove the obstruction and press ⁄ to restart the pump.

A value was not saved by pressing ¤. Press „ to resume programming. Verify all programming screens before moving to the next screen or starting the pump.

„

Reference

Section 5: Reference

Cleaning the Pump and Accessories

CAUTION:

• Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment. Moisture build-up inside the pump may damage the pump.

• Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners, as damage to the pump may occur.

Routinely clean the pump to keep it free of dirt, liquids, and foreign objects.

Use any of the following solutions to clean the pump and accessories:

• Soap solution

• Benzalkonium Chloride concentrate (0.13%)

• Glutaral Concentrate, USP (2%)

• 10 percent solution of household bleach (one part household bleach to nine parts water)

• Alcohol, USP (93%)

• Isopropyl Alcohol, USP (99%)

• Chlorohexidine (70%)

• PDI — Super Sani-Cloth

• Mada Medical — MadaCide

1. Dampen a soft, lint-free cloth with cleaning solution and wipe the exterior surface of the pump. Do not allow the

solution to soak into the pump.

2. Wipe the entire surface dry with another soft, lint-free cloth. Allow the pump to dry completely before use.

Reference

Section 5: Reference

Cleaning the Battery Contacts

Routinely clean the battery contacts, possibly as part of the preventative maintenance cycle, to remove buildup of foreign material on the contacts.

Use the following to clean the battery contacts:

• Cotton swab wetted with Isopropyl Alcohol (70% minimum)

NOTE: Do not use an alcohol formulation that contains components other than alcohol and water.

• Pre-moistened alcohol swab

1. Using a swab wetted with alcohol, rub the entire battery contact for a minimum of ten back and forth cycles (twenty total wipes over the contact).

Reference

2. Using a clean surface of the swab, repeat process for second battery contact.

3. Using a clean swab wetted with alcohol, rub each battery contact again, a minimum of four back and forth cycles (eight total wipes over the contact).

4. Allow the contacts to dry completely before use.

Section 5: Reference

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

CAUTION:

• Do not expose the pump to therapeutic levels of ionizing radiation as permanent damage to the pump’s electronic circuitry may occur. The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions. If the pump must remain in the vicinity during a therapy session, it should be shielded, and its ability to function properly should be confirmed following treatment.

• Do not expose the pump directly to ultrasound, as permanent damage to the pump’s electronic circuitry may occur.

• Do not use the pump in the vicinity of magnetic resonance imaging (MRI) equipment as magnetic fields may adversely affect the operation of the pump. Remove the pump from the patient during MRI procedures and keep it at a safe distance from magnetic energy.

• Do not use the pump near ECG equipment as the pump may interfere with the operation of the equipment. Monitor ECG equipment carefully when using this pump.

Reference

Section 5: Reference

Technical Description

Standards used in Development of the Pump

The following standards were used in whole or part in the development of the pump.

Medical Electrical Equipment

IEC 60601-1, Medical Electrical Equipment, Part 1: General Re-

quirements for Safety.

IEC 60601-1-1, Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Safety requirements for medical electrical systems.

IEC 60601-1-2 (1993), General Requirements for Safety, Part 2: Electromagnetic Compatibility — Requirements and Tests.

IEC 60601-1-2, (2nd Edition, 01-June-1996) Medical Electrical Equipment, Part 1: General Requirements for Safety. 2. Collateral Standard: Electromagnetic Compatibility — Requirements and Tests.

IEC 60601-1-4, Medical Electrical Equipment, Part 1: General Requirements for Safety — 4. Collateral standard: Programmable electrical medical systems.

Reference

IEC 60601-2-24, Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Infusion Pumps and Controllers.

Electromagnetic Compatibility

RTCA/DO -160C, Radiated Emissions Only, Category A & Z Limit.

CISPR11, Radiated and Conducted Emissions, Group 1, Class B.

CISPR14, Radiated and Conducted Emissions, device powered by

AC adapter only.

For CISPR11 and CISPR14 tests, the pump was fitted with an administration set with its inlet connected to a 250 ml bag and its outlet routed back to the bag forming a closed loop system. A total of six feet of tubing was used to form the closed loop.

IEC 61000-3-2, Harmonic Distortion, Class A equipment, only for devices powered @ 220 VAC or greater.

Section 5: Reference

IEC 61000-3-3, Voltage Functions and Flicker, only for devices powered @ 220 VAC or greater.

IEC 61000-4-2, 8 kV contact discharge, 15 kV air discharge.

IEC 61000-4-3, Radiated Susceptibility, 26 MHz to 2500 MHz,

10 V/m, 1 kHz – 80% AM modulation.

IEC 61000-4-4, AC Fast Transients, at ±500 volts, ±1000 volts, and ±2000 volts – AC mains plug.

IEC 61000-4-5, AC Surges, 1 kV differential mode, 2 kV common mode.

IEC 61000-4-6, Conducted Disturbances, AC mains plug, 3V, 150 kHz - 80 MHz.

IEC 61000-4-8, AC Magnetic field, at 400 Amperes/meter at 50 Hz.

IEC 61000-4-11, AC Steady State, Dropout & Slow Sags/Surges.

ENV 50204, Digital Radio Telephone, 10 V/m, 900 ± 5 MHz, 50 %

duty cycle and 200 rep. frequency.

Specifications (Nominal)

General Pump Specifications

Resolution .......................... Medication Cassette™ Reservoir or

CADD® Administration Set, 0.050 ml per pump stroke nominal

Size ...................................... 4.1 cm × 9.5 cm × 11.2 cm (1.6 in. × 3.8

in. × 4.4 in.) excluding cassette or other accessories

Weight ................................ 392 g (13.8 oz.) including two AA

batteries, empty 100 ml Medication Cassette™ Reservoir, and excluding other accessories

Classification

(IEC 601-1) ........................ CF J, Class II K

Moisture Protection .......... Splashproof (E)

Reference

Section 5: Reference

Pump Alarms ..................... Low battery power; depleted battery

power; battery dislodged; pump stopped; pump fault; low reservoir volume; high delivery pressure; air in line; disposable not attached when run attempted; motor locked; upstream occlusion; reservoir volume empty; program incomplete; key stuck; disposable detached.

Maximum Infusion

Pressure .............................. 40.0 psi [2.76 bar]

Maximum Time to

Occlusion Alarm ............... CADD® Administration Set with anti-

siphon valve: 2.0 hours

Bolus Volume at Occlusion Alarm

Pressure .............................. 0.050 ml resolution CADD® Administra-

tion Sets/Medication Cassette™ Reservoirs: <0.15 ml

Power Sources ................... Two AA alkaline batteries; AC Adapter.

The expected life of two AA batteries is 15 hours at 125 ml/hour, or approximately 14 days at 10 ml/day (nominal). This estimate is based on laboratory tests conducted at room temperature using two new batteries. Actual battery life will vary depending on the brand of battery, battery shelf life, temperature conditions, and delivery rate. It is recommended that two new AA batteries be kept available for replacement if necessary.

Reference

An internal battery powers the clock. When it is depleted, it cannot reliably maintain the clock time. This battery must be replaced by the manufacturer. The internal battery has an expected life of 5 years.

System Operating

Temperature ...................... +2°C to 40°C (35°F to 104°F)

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System Storage

Temperature ...................... -20°C to 60°C (-4°F to 140°F)

System Delivery

Accuracy ............................ ± 6% (nominal). At low infusion rates,

this accuracy may not be achieved for short periods. During the total infusion time, the accuracy averages out (see accuracy curves, pages 62 and 63)

System Definition .............. System is defined as a CADD-Legacy

™

pump with an attached Medication Cassette™ Reservoir and CADD® Extension Set with integral anti-siphon valve, or an attached CADD® Administration Set with integral or add-on anti-siphon valve.

High Pressure Alarm ........ 26 ± 14 psi [1.79 ± 0.97 bar].

Air Detector Alarm ........... Single bubble

Low sensitivity = greater than 0.250 ml High Sensitivity = greater than 0.100 ml Multi-bubble = 1.0 ml nominal

Maximum Volume Infused under Single

Fault Condition ................. CADD® Administration Set with anti-

siphon valve: 0.2 ml.

Delivery Rate during

priming ............................... Approx. 180 ml/hr

Alarm Disabled during

priming ............................... Air Detector

Reference

Section 5: Reference

Continuous Delivery Mode Specifications

Reservoir Volume .............. 1 to 9999 or Not In Use; programmable

in 1 ml increments, displayed in 0.1 ml increments Default: 1.0 ml

Continuous Rate ............... 0.1 to 125 ml/hr; programmable in

0.1 ml /hr increments Default: 0.0 ml

Given .................................. 0 to 99999.95 in 0.05 ml increments

Intermittent Delivery Mode Specifications

Reservoir Volume .............. 1 to 9999 or Not In Use; programmable

in 1 ml increments, displayed in 0.1 ml increments Default: 1.0 ml

Dose Volume ..................... 0.1 to 1000 ml programmable in 0.1 ml

increments Default: 0.0 ml

Dose Duration ................... 1 min to 24 hrs in the following incre-

ments: 1 minute for values between 1 min and 10 min 5 minutes for values above 10 min Duration is limited by Dose Volume so that rate does not exceed 125 ml/hr. Default: 30 min

Reference

Dose Cycle ......................... 10 min to 96 hrs in 5 minute increments:

Default: 4 hrs

KVO Rate .......................... 0 to 125 ml/hr in 0.1 ml/hr increments

Default: 0 ml/hr

Dose Starts in .................... Immediate or 1 min to 96 hrs in the

following increments: 1 minute for values between 0 min and 10 min 5 minutes for values between 10 min and 96 hrs Default: Immediate

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Given .................................. 0 to 99999.95 in 0.05 ml increments

Dose Remaining ................ 1 minute increments

Biomed Functions

Air Detector ....................... Off

On-Low On-High Default: On-High

Upstream Sensor

Delivery Mode ................... Continuous

............... Off

On Default: On

Intermittent Default: Intermittent

Reference

Section 5: Reference

Accuracy Test Results

The following graphs are designed to show flow accuracy of the infusion system plotted against given time periods.

Flow rate immediately following startup

Time Interval: 0.5 min Total Time: 120 min Programmed Rate: 24.0000 ml/hr Cassette used: CADD® Administration Set with

anti-siphon valve

Flow

(ml/hr)

0 12012010080604020 1109070503010

Short term flow rate error

Programmed Rate: 24.0000 ml/hr Average Flow Rate: 23.9227 ml/hr Mean Flow Error: -0.32% Cassette used: CADD® Administration Set with

Reference

% Error of Flow

T (min)

anti-siphon valve

T (min)

Flow rate immediately following startup

Time Interval: 15 min Total Time: 1500 min Programmed Rate: 0.1 ml/hr Cassette Used: CADD® Administration Set with anti-

siphon valve

Flow

(ml/hr)

Short term flow rate error

Programmed Rate: 0.1 ml/hr Average Flow Rate: 0.0989 ml/hr Mean Flow Error: -1.05% Cassette Used: CADD® Administration Set with anti-

siphon valve

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T (min)

% Error of Flow

Reference

T (min)

Section 5: Reference

Safety Features and Fault Detection

Hardware Safety Features

Key hardware safety features include a watchdog timer circuit, motor driver and motor watchdog circuits, and a voltage detector circuit. Each safety circuit performs a unique function to insure the overall safety of the device.

Watchdog Timer Circuit

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

Watchdog timer circuitry is provided to monitor the status of the microprocessor and disable the motor and enable the audible alarm if the microprocessor fails to function properly. The microprocessor must strobe the watchdog circuit at least once every second in order to prevent the watchdog from performing its reset function. The reset output from the watchdog circuit is a pulse output. This acts to “jump start” the microprocessor. This unique feature allows the microprocessor to test the watchdog circuit on every power-up.

By setting a flag in the memory and not strobing the watchdog, the microprocessor can force a watchdog time-out. After being reset, the microprocessor checks the status flag to see if this was a timeout test. If so, the microprocessor continues normal power-up activities. If the reset occurred when the microprocessor was not expecting it, the microprocessor traps the event, sounds the audible alarm and displays an error message on the LCD.

Reference

Motor Driver/Motor Watchdog Circuit

Motor drive circuitry is composed of a series of power FET transistors, passive components, and two voltage comparators. Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on. If the motor runs for more than an average of 3 seconds, the circuit will time out and disable

Section 5: Reference

the motor. A unique feature of this circuit is that control lines to and from the microprocessor circuit allow the microprocessor to perform a complete functional test of the motor drive circuit without running the motor. The microprocessor performs this test function every several minutes to assure its continued functionality. An input from the watchdog circuit prevents motor operation if the watchdog timer expires. The software verifies this function during the watchdog test described above.

Voltage Detector Circuit

Low voltage detection is performed by part of the Watchdog Circuit and by the microprocessor via software. Three low voltage levels are detected. The first two levels are detected by software and the third by hardware. The first level to be reached is the Low Battery Warning threshold which occurs when the battery voltage decays to a nominal value of 2.4 volts when the motor is off or 1.8 volts when the motor is active. An Analog to Digital Converter (ADC) built into the microprocessor allows the microprocessor, via software, to monitor the battery voltage. At the Low Battery Warning threshold, the microprocessor enables a periodic series of beeps and displays a low battery warning message on the LCD. As the voltage operating the motor reaches a nominal value of 4.75 volts, the software disables delivery, places a battery depleted message on the LCD, and enables a constant two tone audible alarm. When the battery voltage decays to a nominal value of 1.0 volts, a hardware reset circuit is triggered which places the microprocessor in reset. This prevents ambiguous microprocessor operation when the battery voltage continues to decay. The hardware reset continues until the battery is completely discharged or until it is removed. Once the pump controller goes into low battery shutdown, only replacing the depleted batteries with new ones will clear the condition.

Reference

Section 5: Reference

Software Safety Features

Hardware-related Software Safety Features

Program Memory Check

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

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

RAM Memory Check

At power up, the random access memory is checked. A series of bit patterns is written to and read from each address in the RAM. If the read data is different from the written data, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all drug delivery.

Motor Circuit Check

At power up and at regular intervals thereafter, the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on. If the software detects power being applied to the motor at any other time, it will sound a continuous two-tone audible alarm and will no longer attempt to deliver medication. During every pump activation, the software checks to see whether the motor completes one activation. If the motor fails to turn, or fails to complete a cycle, the software will display a system fault screen, turn on a continuous two-tone audible alarm,

Reference

and stop all drug delivery.

Keyboard Encoder Check

Every time the software receives data from the keyboard encoder, it is checked. If the data is not a valid key press, the software will disregard the key press. The keyboard is designed with redundant

Section 5: Reference

switches for switches are activated before taking any action.

‹

and

. The software must detect that both

⁄

Data Handling Software Safety Features

Data Stored in RAM

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

Data Stored in EEPROM

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

Data Stored in NOVRAM

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

Data Used in Calculations

Calculations on data used in some way to control the delivery of drug are performed redundantly.

The two calculated values are then compared. If the two values do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all drug delivery.

Timer Data Registers

The data in the Real Time Clock is checked at regular intervals. If the data is not reasonable, the software will turn on a continuous

Reference

Section 5: Reference

two-tone audible alarm and stop all drug delivery.

Annual Functional Inspection and Testing Procedures

Deltec recommends annual functional inspections and tests on all CADD-Legacy™ pumps. The following inspection and testing procedures should be performed annually to verify function and accuracy. The pump must be in Lock Level 0 (LL0) to perform the following inspections and tests.

NOTE: Persons performing the following tests and procedures should be familiar with the CADD-Legacy entire Operator’s Manual before proceeding.

CAUTION: CADD-Legacy™ pumps are sealed units. A broken or damaged seal will, therefore, be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD-Legacy™ pumps must be performed by Deltec or its authorized agents.

™

pump. Please read the

Inspection Procedures

Visual Inspection

• Visually inspect the pump for any damage to the LCD, occlusion sensor seals, valves and expulsor, pump hinge area, lock, cassette sensor, keypad, indicator light, power jack, accessory jack, air detector, and housing.

Reference

• Check the battery door for proper operation. It should not be broken or damaged. The mating tabs on the pump housing should not be broken or damaged.

• Examine the battery compartment for damage. If the battery contacts appear corroded, clean them with a cotton swab and isopropyl alcohol (see Cleaning the Battery Contacts). If the battery contacts appear to be bent or pushed in, straightening may be possible with a small screwdriver or other

Section 5: Reference

suitable tool. Care must be taken not to damage the pump housing or to incur further damage to the contacts.

Mechanical Inspection

• Press each key on the keypad. Each key should have a distinctive dome feeling. The keys should not feel flat.

• Attach the battery door. The battery door should fit snugly in place when it is closed on the pump.

• Attach either a 50 or 100 ml Medication Cassette voir or a CADD® Administration Set to the pump. Using a coin, turn the lock 1/4 turn counterclockwise. Check for smooth operation and a definite “feel” when the lock pulls the cassette firmly against the bottom of the pump. The slot on the lock should be aligned with the arrow on the side of the pump.

• Gently twist and pull on the cassette to make sure it is firmly attached.

™

Reser-

Testing Procedures

Functional Testing

Power-up Check

• Insert batteries or press Å and observe the LCD during power up. The first screen will display the serial number, model number, and software number with revision level. The second screen will display 32 character blocks. (If “LEC” (Last Error Code) and four digits appear prior to the pump displaying the 32 character blocks, the pump has experienced an electrical or mechanical fault and should be returned for service.) If no error message is immediately shown, the pump has powered up normally. The pump will then sequentially display all of the programmed values and beep at each screen. After all screens are displayed, success-

Reference

Section 5: Reference

ful power up is indicated with six audible beeps and the “STOP” screen displayed. Continue with the lock check.

Lock Check

• Attach a 50 or 100 ml Medication Cassette™ Reservoir or CADD® Administration Set to the pump. The line on the lock should be aligned with the arrow on the side of the pump.

Cassette Sensor Check

• Unlock the cassette by inserting a coin into the lock and turning clockwise.

• The pump will sound a continuous two-tone alarm and the display should show “No Disposable, Clamp Tubing.”

• Press

The following three checks (LCD, Motor and Gear Train and Reservoir Volume Empty Alarm Check) should be performed in the sequence shown.

⁄ or „ to silence the alarm. Press and hold Å

to turn the pump off.

LCD Check

• With the pump turned off, press Å. The second screen that the pump displays will consist of 32 blocks of characters. Examine the LCD to verify that there are no missing dark in the character blocks.

Motor and Gear Train Check

Reference

• Program the Reservoir Volume to 2.0 ml.

™

• Attach a 50 or 100 ml Medication Cassette CADD® Administration Set to the pump. Lock the cassette.

• Press and hold

until three series of dashes appear.

‹

Reservoir or

Section 5: Reference

Release tubing, listen to the motor for excessive noise or grinding sounds. Count the number of pump activations. The pump should prime ten double activations and then stop. Press

. Press and hold

‹

. While priming the

‹

„ to return to the main menu.

Reservoir Volume Empty Alarm Check

• Program the Reservoir Volume to 1.0 ml. Press „ until

Reservoir Volume is displayed on the LCD. Press

until 1.0 ml is displayed. Then press

• Press and hold Release ten double activations and then stop. The pump will alarm and display “Reservoir Volume Empty.” Press

Starting/Stopping the Pump

• Program the pump with the following values:

Reservoir Volume: 1.0 ml

Continuous Rate: 50 ml/hr

. Press and hold

‹

until three series of dashes appear.

‹

. The pump should prime

‹

„

Given: 0.00 (press

• Program the Air Detector Off (see Section 4, Biomed Functions).

• Press and hold sets of dashes, each accompanied by a beep. A review of the programmed parameters then appears. The main screen should appear with “RUN” in the display.

• To stop the pump, press and hold followed by three sets of dashes that disappear one at a time, each accompanied by a beep. The main screen should appear with “STOPPED” in the display.

. “Starting” appears followed by three

⁄

¤)

. “Stopping” appears

⁄

Reference

Section 5: Reference

Activation Timing Check

• Reprogram the Reservoir Volume to 1.0 ml and clear the Given screen.

• Press and hold display. The pump should sequentially display all of the programmed values. Start a timer at the first motor activation.

• Count the activations. One activation should occur every six seconds. Approximately 66 seconds and ten activations later, the Reservoir Volume empty alarm should occur. The display should show “Reservoir Volume empty.”

⁄ until three dashed disappear from the

GIVEN Check

• Stop the pump by pressing and holding ⁄. Press „ to advance to the Given screen. The display should show 2.00 ml. (If the above steps have not been followed exactly, a different value may appear.)

• Press

¤. The display should now show 0.00 ml.

Air Detector Test

• Turn the Air Detector On (see Section 4, Biomed Functions).

• Reprogram the Reservoir Volume to 10.0 ml. Press until Reservoir Volume is displayed on the LCD. Press or Î until 10.0 ml is displayed. Then press

„

Reference

• Attach an empty 50 or 100 ml Medication Cassette voir or CADD® Administration Set to the pump. Secure it using the lock button.

• Thread the tubing through the Air Detector groove.

• Start the pump.

™

Reser-

Section 5: Reference

• The pump should respond with a continuous two-tone alarm and the display should read “Air In Line Detected.”

• Press

„ or ⁄ to silence the alarm and remove the

™

empty Medication Cassette

Reservoir or CADD® Adminis-

tration Set.

™

• Now attach a Medication Cassette

Reservoir containing fluid, or a primed CADD® Administration Set to the pump. Lock the cassette. Make certain that there is no air in the fluid path. Secure it using the lock button.

• Thread the tubing into the Air Detector groove.

• Start the pump. The pump should deliver without activation of the air detection alarm.

Upstream Occlusion Sensor Test

• Verify the Upstream Occlusion Sensor is turned On (see Section 4, Biomed Functions).

• Obtain a CADD anti-siphon valve. Also obtain a clamp (slide clamp or hemostat).

• Insert the CADD priate, standard IV bag filled with water. Attach the cassette to the pump. Prime the entire fluid path.

Administration Set with bag spike and

Administration Set spike into an appro-

Reference

• Program the pump to deliver a continuous maximum rate. Press and hold

to start the pump.

⁄

• Clamp the tubing halfway between the IV bag and the pump. The pump should alarm within three activations after clamping the tubing.

Section 5: Reference

Occlusion Pressure Range Tests

Occlusion Pressure Range Test I

Description

Pressure is generated by activating the pumping mechanism with an attached filled, clamped Medication Cassette™ Reservoir. The pump is started and fluid is injected until the high pressure alarm sounds.

Equipment needed

50 or 100 ml Medication Cassette™ Reservoir containing distilled water

1-ml syringe

Procedure

1. Insert two AA batteries or turn pump on and wait for the pump to power up.

Reference

2. Attach a Medication Cassette

™

Reservoir containing water

to the pump.

™

3. Prime the Medication Cassette

Reservoir tubing. The tubing should be filled with fluid to the end of the luer lock connector. The system must be free from air bubbles for this test.

4. Withdraw the plunger of the empty 1-ml syringe to the 1.0ml marking. Now attach the syringe to the end of the

™

Medication Cassette

Reservoir tubing.

5. Start the pump.

6. When the pump is running, slowly depress the plunger of the syringe, noting when the High Pressure alarm is activated.

Section 5: Reference

7. The pump should alarm when the syringe is between 0.5 and 0.1 ml.

Occlusion Pressure Range Test II

Description

An adjustable metered pressure source is connected to the Medication

™

Cassette

Reservoir tubing. The pressure is slowly increased until the

high pressure alarm sounds.

Equipment needed

Pressure gauge, 40 ± 1 psi [2.76 ± 0.07 bar]

Pressure vessel, partially filled with water

Pressure regulator, 40 psi [2.76 bar]

™

50 or 100 ml Medication Cassette

Reservoir containing water

Procedure

1. Insert two AA batteries and wait for the pump to power up.

™

2. Attach a Medication Cassette

NOTE: The pressure from the source must be zero when the cassette is attached.

3. Assemble the apparatus as shown.

Reservoir to the pump.

Reference

1999-01-23 D. Zurn «Lgc Occlusion NoText»

Regulator Pressure Gauge

Section 5: Reference

4. Connect the Medication Cassette™ Reservoir outlet tube to the metered pressure source.

NOTE: Do not use a CADD

Extension Set with Anti-Siphon

Valve.

5. Start the pump and run at 50 ml/hr.

6. Slowly increase the backpressure, noting when the high pressure alarm is activated.

NOTE: The pressure may be increased rapidly to 8 psi [0.55 bar], after which the pressure should be increased at 3 psi/min [0.21 bar/min] or less until the alarm sounds.

7. The high pressure alarm should sound between 12 and 40 psi (26 ± 14 psi) [between 0.82 and 2.76 bar (1.79 ± 0.97 bar)].

CAUTION: At the completion of the test, the pressure must be reduced to zero before detaching the cassette from the pump; otherwise, the cassette may rupture. Safety glasses should be worn while conducting or observing this test.

Reference

Section 5: Reference

Accuracy Tests

Gravimetric Accuracy Testing

Description

A Medication Cassette™ Reservoir is partially filled with water and weighed, then attached to a pump that is set to deliver a certain amount of water. The Medication Cassette removed and weighed again. The amount of water delivered is compared to the amount that the pump should have delivered.

Nominal system accuracy is given in the technical specifications section for the pump. That is, under the test conditions described below, the accuracy of the pump and Medication Cassette voir will be nominal with a 90% confidence level. The nominal test conditions are as follows: degassed water at 25 ± 5°C without back pressure.

Equipment needed

™

Reservoir is then

™

Reser-

50 or 100 ml Medication Cassette™ Reservoir

50 or 60 ml syringe

CADD

Extension Set with Anti-Siphon Valve

A balance accurate to 0.1 g

40 ml of room temperature water

Procedure

1. Fill the 50 or 60 ml syringe with 40 ml of water. Transfer the water into a Medication Cassette™ Reservoir.

2. Remove any air from the Medication Cassette by aspirating the air with the syringe. Attach the CADD Extension Set with Anti-Siphon Valve. Prime the tubing so it is filled with fluid to the end of the extension set luer

™

Reference

Reservoir

Section 5: Reference

lock connector.

3. Secure the slide clamp as close to the extension set luer lock connector as possible. This should assure a minimum water loss from the tubing when the syringe is removed.

™

4. Weigh the entire Medication Cassette

Reservoir/extension set and record the weight. This is the predelivery weight. (This weight includes the empty Medication Cassette Reservoir, extension set, and weight of the water.)

5. Attach the cassette to the pump. Program the Reservoir Volume to 20 ml. Now press

. This value is the in-

tended delivery volume. (One ml of water at 20°C weighs 1 gram.) Remove the slide clamp.

6. With the pump in Lock Level 0, program a Continuous Rate of 125 ml/hr. Start the pump and wait for the reservoir volume empty alarm. The pump will deliver 20 ml.

7. Again, secure the slide clamp as close as possible to end of the extension set luer lock connector. Remove the cassette from the pump and weigh the entire Medication Cassette Reservoir/extension set assembly. This is the postdelivery weight.

™

Reference

8. Calculate the difference in weight between the predelivery weight and the postdelivery weight. This is the weight of the amount delivered.

9. Find the difference between the actual delivery volume and the intended delivery volume. This is the inaccuracy volume.

10. Divide the inaccuracy volume by the intended delivery volume and multiply by 100. This is the accuracy error percentage.

11. If the accuracy error percentage is greater than ± 6%, repeat

™

the test with a new Medication Cassette

Reservoir. If the

Section 5: Reference

pump fails a second time, call SIMS Deltec or SIMS Graseby Ltd.

Example: Predelivery Weight: 61.1 g

Postdelivery Weight: – 41.6 g

Weight of Amount Delivered: = 19.5 g

Volume of Amount Delivered: 19.5 ml Intended Delivery Volume: – 20.0 ml

Inaccuracy Volume: = –0.5 ml

Inaccuracy Volume: –0.5 ml Intended Delivery Volume: ÷ 20.0 ml

Accuracy Error: = –0.025

Accuracy Error: -0.025

× 100.00

Accuracy Error Percentage: = –2.5%

Reference

Section 5: Reference

Volumetric Accuracy Testing

Description

A predetermined amount of water is delivered into a collection device such as a burette or graduated cylinder. The amount of water delivered is compared to the amount that the pump is programmed to deliver.

Nominal system accuracy is given in the technical specifications section for the pump. That is, under the test conditions described

™

below, the accuracy of the pump and Medication Cassette

Reservoir will be nominal with a 90% confidence level. The nominal test conditions are as follows: degassed water at 25 ± 5°C without back pressure.

Equipment needed

50 or 100 ml Medication Cassette™ Reservoir

50 or 60 ml syringe

Procedure

Reference

CADD

Extension Set with Anti-Siphon Valve

A fluid collection device such as a burette or a Class A, 25 ml

capacity graduated cylinder

40 ml of room temperature water

1. Fill the 50 or 60 ml syringe with 40 ml of water. Transfer the water into a Medication Cassette™ Reservoir.

™

2. Remove any air from the Medication Cassette aspirating the air with the syringe. Attach the CADD

Reservoir by

Extension Set with Anti-Siphon Valve. Prime the tubing so it is filled with fluid to the end of the extension set luer lock connector.

Section 5: Reference

3. Attach the end of the extension set to the fluid collection device.

4. Attach the cassette to the pump. Program the Reservoir Volume to 20 ml. This is the intended delivery volume. Remove all clamps.

5. Program a Continuous Rate of 125 ml/hr. Start the pump and wait for the reservoir volume empty alarm.

6. When delivery is complete, record the volume of fluid delivered. This is the actual delivery volume.

7. Find the difference between the actual delivery volume and the intended delivery volume. This is the inaccuracy volume.

8. Divide the inaccuracy volume by the intended delivery volume and multiply by 100. This is the accuracy error percentage.

9. If the accuracy error percentage is greater than ± 6%, repeat

™

the test with a new Medication Cassette

Reservoir. If the pump fails a second time, call SIMS Deltec or SIMS Graseby Ltd.

Example: Actual Delivery Volume: 19.5 ml

Intended Delivery Volume: – 20.0 ml

Inaccuracy Volume: = –0.5 ml

Inaccuracy Volume: –0.5 ml Intended Delivery Volume: ÷ 20.0 ml

Accuracy Error: = –0.025

Accuracy Error: -0.025

× 100.00

Accuracy Error Percentage: = –2.5%

Reference

Section 5: Reference

Index

Bold page numbers indicate figure references

AC Adapter, 6, 7 AC indicator light, 4 accessory jack, 3, 4 accuracy tests, 62–63

gravimetric, 77 volumetric, 80

Administration Set, 6

attaching, 32 cautions, vi warnings, iv

Air Detector, 4, 16, 46, 61

inserting tubing into, 36 status screen, 21, 22, 27, 29, 30 testing, 72–73

warning, iv alarms, 49–52, 58 anesthetics

caution, vii Anti-Siphon Valve, 6

warning, iv arrow keys, 4, 5

Biomed Functions Code, 9, 45

cassette, 4, 6

attaching, 32 cautions, vi removing, 31

warnings, v cassette lock, 4, 7, 33 cleaning pump, accessories, 53–54

cautions, vi Continuous Delivery Mode, 19 Continuous Rate, 10, 21, 39, 60

programming, 22 cycle, 19

definition, system, 59 delivery method, 19

changing, 48 Dose Cycle, 26, 60 Dose Duration, 25, 60 Dose Remaining, 26, 41, 61 Dose Starts In, 19, 26, 41, 60 Dose Volume, 25, 60 Downstream occlusion sensor, 8

batteries, AA, 7, 11–15, 57, 58

cautions, vi

Reference

installing, 11–15

warnings, v battery compartment, 4, 7 battery contacts, cleaning, 54 battery, internal clock, 58 battery life, 15, 58 Biomed Functions, 45–85

Air Detector on/off, 46, 61

Upstream Sensor on/off, 47, 61

ECG equipment, interference

with, vi, 55

epidural administration

warning, iv

Extension Set

Anti-Siphon Valve, 6 warning, iv

Given screen, 22, 27, 29, 60, 61

clearing, 22, 28, 29

Section 5: Reference

indicator light, 4, 5 inspection procedures, 68 Intermittent Delivery Mode, 19

keypad, keys, 4, 5 KVO rate, 19, 26, 60

lock, cassette, 7, 33 lock level, 5, 9, 10 Lock Level Code, 9, 17, 38, 45

Magnetic Resonance Imaging

caution, vi, 55 main screen, 8, 43 mounting hole, threaded, 4

Polemount Bracket Adapter, 7 power jack, 3, 4 power-up, 16 priming, 27

warning, v programming, 18 programming screens

Continuous delivery mode, 20

Intermittent delivery mode, 24

radiation, exposure to

caution, vi, 55 reservoir, 6, 7, 20, 22, 25, 28, 51, 57

attaching, 32

cautions, vi

removing, 31 warnings, iv

Reservoir Volume, 8, 10, 20, 22,

25, 28, 34, 51, 52, 58, 60

resetting, 44

safety features

hardware, 64 software, 66–67

security codes

Biomed Functions Code, 9, 45

Lock Level Code, 9, 17, 38 service due, 52 software version, ii, 16 specifications

Biomed Functions, 61

general, 57 standards, 62 starting the pump, 43 stopping the pump, 43 subarachnoid administration

warning, iv symbols, 3 syringe, warning, iii system definition, 59

turning pump on/off, 44

ultrasound, 55

caution, vi, 55 Upstream occlusion sensor, 7, 21,

23, 27, 47, 61

testing, 73

warnings and cautions, iii–vii

Reference

Section 5: Reference

Limited Warranty

SIMS Deltec, Inc. (the “Manufacturer”) warrants to the Original Purchaser that the infusion pump (the “Pump”), not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with this Operator’s Manual, for a period of one year from the actual date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.

This warranty does not cover normal wear and tear and maintenance items, and specifically excludes batteries, administration sets, extension sets or any other accessory items or equipment used with the Pump.

Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any Pump (not including accessories) which is defective if a claim is made during such one-year period.

The following conditions, procedures, and limitations apply to the Manufacturer’s obligation under this warranty:

A. Parties Covered by this Warranty: This warranty extends only to the Original Purchaser of the Pump. This warranty does not extend to subsequent purchasers. The Original Purchaser may be a patient, medical personnel, a hospital, or institution which purchases the Pump for treatment of patients. The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase.

B. Warranty Performance Procedure: Notice of the claimed defect must be made in writing or by telephone to the Manufacturer as follows: SIMS Deltec 1265 Grey Fox Road, St. Paul MN 55112 U.S.A., 1-800-426-2448 or SIMS Graseby Ltd. WD2 4LG UK, +44 (0)1923 246434. Notice to the Manufacturer must include date of purchase, model and serial number, and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE PUMP. If authorized, the Pump must be properly and carefully packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of the sender.

C. Conditions of Warranty: The warranty is void if the Pump has been 1) repaired by someone other than the Manufacturer or its authorized agent; 2) altered so that its stability or reliability is affected; 3) misused; or, 4) damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Operator’s Manual or use with nonapproved accessories. The Pump is a sealed unit, and the fact that the seal has been broken will be considered conclusive evidence that the Pump has been altered or misused. Removal or damage to the Pump’s serial number will invalidate this warranty.

D. Limitations and Exclusions: Repair or replacement of the Pump or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply:

Reference

1. No agent, representative, or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty, expressed or implied.

2. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE PUMP FOR ANY PARTICULAR PURPOSE.

3. The Pump can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the Pump for any particular medical treatment.

4. All recommendations, information, and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reliable, but do not constitute warranties.

Section 5: Reference

E. Computer Program License:

1. The Pump is intended to be used in conjunction with a particular Licensed Computer Program supplied by Manufacturer and use of any other program or unauthorized modification of a Licensed Computer Program shall void Manufacturer’s warranty as set forth above.

2. The Original Purchaser and any users authorized by the Original Purchaser are hereby granted a nonexclusive, nontransferable license to use the Licensed Computer Program only in conjunction with the single Pump supplied by Manufacturer. The Licensed Computer Program is supplied only in machine-readable object code form and is based upon Manufacturer’s proprietary confidential information. No rights are granted under this license or otherwise to decompile, produce humanly readable copies of, reverse engineer, modify or create any derivative works based upon the Licensed Computer Program.

3. All other terms and conditions of this Limited Warranty shall apply to the Licensed Computer Program.

The Manufacturer disclaims responsibility for the suitability of the Pump for any particular medical treatment or for any medical complications resulting from the use of the Pump. The Manufacturer shall not be responsible for any incidental damages or consequential damages to property, loss of profits, or loss of use caused by any defect or malfunction of the Pump.

This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights which may vary from state to state.

Reference

U.S. Distribution:

SIMS Deltec, Inc. 1265 Grey Fox Road St. Paul, Minnesota 55112 U.S.A. 1-800-426-2448

European Representative:

SIMS Graseby Ltd. WD2 4LG UK +44 (0)1923 246434

2000-03

40-3934-51D

Smiths Cadd-Legacy 1 Plus 6500 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual