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SIMS Deltec CADD-PLUS 5400 Operator's Manual

Ambulatory infusion pump
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Deltec
SIM S D elt ec, In c., St . Pau l, M N 55112 U .S.A.
CADD-PLUS
Ambulatory Infusion Pump
Model 5400
O perator's Manual
®
i

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Summary of Contents for SIMS Deltec CADD-PLUS 5400

  • Page 1 This online version differs from the printed version. Note: Colors are Black and Cyan (as second color) Certain information that is not intended for patients has been removed. CADD-PLUS ® Ambulatory Infusion Pump Model 5400 O perator’s Manual Deltec SIM S D elt ec, In c., St . Pau l, M N 55112 U .S.A.
  • Page 2 The issue date of this Operator’s Manual is included 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. WARNING: It is intended that this O perator’s Manual only be utilized by clinicians.
  • Page 3 800-426-2448. Our staff is available to help clinicians twenty-four hours a day with the programming ® and operation of the CADD-PLUS infusion pump. SIMS Deltec, Inc. 1265 Grey Fox Road St. Paul, Minnesota 55112 U.S.A.

  • Page 4: Table Of Contents

    CONTENTS INTRODUCTION ................... 1 GENERAL DESCRIPTION OF CADD-PLUS PUMP OPERATIONS .. 1 ® WARNINGS and CAUTIONS ............2 2.1.1 WARNINGS ................. 2 2.1.2 CAUTIONS ................3 Physical Description of the Pump and Accessories ...... 4 2.2.1 Items Packaged with the Pump ......... 2.2.2 Description of the Function Keys and Display Panel ..
  • Page 5 3.4.4 Setting the Delivery period (PERIOD) ....... 28 3.4.5 Setting the Delivery CYCLE (CYCLE) ....... 29 3.4.6 Setting the KEEP VEIN OPEN (KVO) Function ....29 3.4.7 Setting the DELAY START (DELAY START) ....30 3.4.8 Reviewing the CYCLE GIVEN Mode ......... 30 3.4.9 Reviewing the GIVEN Mode ..........

  • Page 7: Introduction

    INTRODUCTION The Deltec CADD-PLUS pump provides measured drug therapy to patients in ® hospital or outpatient settings. Health care professionals should use this manual to learn how to operate the pump. ® The purpose of this manual is to familiarize you with the CADD-PLUS pump’s functions, which are described in Section 2;...

  • Page 8: Warnings And Cautions

    2.1 WARNINGS and CAUTIONS Read this entire Operator’s Manual before operating the CADD-PLUS ambulatory ® infusion pump. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. 2.1.1 WARNINGS • Do not use a pump that appears to have been damaged or tampered with, or is not functioning properly.

  • Page 9: Cautions

    • To prevent the uncontrolled flow of medication, use a CADD Extension Set with ® Anti-Siphon Valve, a CADD ® Administration Set with integrated anti-siphon valve, ® or a CADD Administration Set with an attached Add On Anti-Siphon Valve. ® •...

  • Page 10: Physical Description Of The Pump And Accessories

    Physical Description of the Pump and Accessories The following diagram, Figure 1, illustrates the CADD-PLUS pump and its ® major functions. DELAY STOP START GIVEN Display (LCD) PERIOD LO BAT CYCLE RES VOL ML/HR STOP Keyboard PRIME START CLEAR SELECT LOCK MODE Scroll Keys...

  • Page 11: Items Packaged With The Pump

    2.2.1 Items Packaged with the Pump Packaged with the pump are the following items: Battery (9-volt) ™ 50 ml Medication Cassette Reservoir (nonsterile, for demonstration only) Carrying case Carrying pouch Operator’s Manual with warranty information ® The following products are also compatible with the CADD-PLUS pump: ™...

  • Page 12: Description Of The Reservoir Or Administration Set

    2.2.3 Description of the Medication Cassette ™ Reservoir or CADD ® Administration Set The CADD-PLUS ® pump may use a detachable Deltec, single use Medication ™ Cassette Reservoir for holding the drug. They are available in 50 ml and 100 ml sizes. ®...

  • Page 13: Understanding The Delivery Modes

    Understanding the Delivery Modes This section introduces the two delivery modes and their associated program- ® ming modes that appear on the CADD-PLUS pump display: (1) the Continu- ous (C) delivery mode; and (2) the Intermittent (I) delivery mode. Further details concerning these delivery modes are introduced in Section 3.3, “Programming the CADD-PLUS Pump for Continuous Delivery,”...

  • Page 14: Continuous Rate (Ml/Hr)

    2.4.2 Continuous Rate (ML/HR) The delivery rate in ML/HR (milliliters per hour) is the constant rate at which the pump delivers medication. The delivery rate range is from 00.1 ml/hr to 75.0 ml/hr in 00.1-ml/hr increments. If you program a delivery rate of 00.0 ml/hr, delivery will not occur.

  • Page 15: The Reservoir-Residual Volume (Res Vol)

    CYCLE DELAY START V olum e PERIOD PERIOD (M L ) (option) (option) (option) T im e (H R : M IN ) t0 to t1 = D EL A Y ST A R T t1 to t2 = PER IO D t1 to t3 = CY CL E Figure 4.

  • Page 16: The Delivery Cycle (Cycle)

    2.5.4 The Delivery CYCLE (CYCLE) To repeat delivery of a preset volume (ML), it is necessary to program the pump for a delivery CYCLE. (See Figure 4.) You will see the current CYCLE time in hours and minutes on the display. You can program the CYCLE from 20 min- utes to 12 hours and 10 minutes.

  • Page 17: The Cycle Given (Cycle Given)

    will not occur, and the pump will begin its delivery immediately. For example, if it is 4:30 pm, and you do not want the delivery of the drug to begin until 6:00 pm, you would program the DELAY START for 1HR:30MIN, which means that the delivery would not begin until 6:00 pm.

  • Page 18: Operator Instrctions

    OPERATOR INSTRUCTIONS This section describes how to operate the CADD-PLUS pump. It contains de- ® tailed, step-by-step instructions that will enable you to perform the following tasks. • Installing a battery and observing the Power-up Test (Section 3.1) .... • Preparing to program the pump (Section 3.2) ..........

  • Page 19: Installing Or Replacing The Battery

    Installing or Replacing the Battery Use a new, 9-volt alkaline or lithium battery to power the pump. (See Section 4.5.3, “General Specifications,” for further information regarding batteries.) WARNING: • Do not use rechargeable NiCad or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (“heavy duty”) batteries.
  • Page 20 STEP 3: Install the battery in the compartment (bot- tom-end first). NOTE: Be sure to m atch the polarity m ark ings of the new battery (+ and –) w ith those on the battery com part- m ent. If you put the battery in back w ards, the display panel w ill be blank , and you w ill not hear a beeping sound.
  • Page 21 will go through an electronic self test. All of the display indicators, the software revision level, and each parameter will appear briefly. If the pump is in LL0, all of the display indicators and software revision level appear, then the display will pause on either “I”...

  • Page 22: Preparing To Program The Cadd-Plus Pump

    Preparing to Program the CADD-PLUS ® Pump The CADD-PLUS pump must be in Lock Level 0 (LL0) in order to program ® the pump. You will need to perform three steps to ensure that the pump is in Lock Level 0 (LL0): 1.
  • Page 23 • Release the STOP/START key after the third dash appears and you hear a second beep. Œ STEP 2: Determine the current lock level of the pump. • Press and release the LOCK key. STOP This example shows that the pump is in Lock Level 1.
  • Page 24 • Press the LOCK key to enter the new lock level into the pump’s Œ memory. • Press the LOCK key again to verify that you are in LL0. Œ STOP • Press the LOCK key two more times in succession to return to Œ...

  • Page 25: Programming The Cadd-Plus Pump For Continuous Delivery

    Programming the CADD-PLUS ® Pump for Continuous Delivery NOTE: M ak e sure that the pum p is set in the Stop m ode and L ock L evel 0 (Section 3.2). 3.3.1 Selecting the Continuous Delivery Mode Remove the battery compartment cover and lift the battery at the contact end until the contacts disengage.

  • Page 26: Setting The Reservoir-Residual Volume (Res Vol)

    If the pump is in the Intermittent mode, „ • Press the SELECT MODE key to change the pump display from the Intermittent mode to the Continuous mode. ¤ • Press the SET/CLEAR key to enter the Continuous mode setting into the pump’s memory and to continue the power-up se- quence.
  • Page 27 NOTE: T he pum p does not actually m easure the volum e of drug rem aining in the fluid container. T he num ber displayed in the R eservoir-R esidual Volum e m ode (R ES V O L ) is calculated by subtracting the current m illiliters of drug given from the initial value you programmed for the R ES V O L .

  • Page 28: Setting The Continuous Delivery Rate (Ml/Hr)

    NOTES: (1) If you do not w ish to use the reservoir-residual volum e feature, set the R ES V O L value to “000”. T hereafter, w hen R ES V O L is displayed, “O FF” w ill appear on the display, and the R ES V O L alarm w ill not function.

  • Page 29: Reviewing The Given Mode

    3.3.4 Reviewing the GIVEN Mode The GIVEN mode displays the total milliliters delivered since the mode was last cleared, including the quantities delivered in either the Continuous or Intermit- tent modes. The number of milliliters in GIVEN increases from 000 to 999 and then automatically resets to 000.

  • Page 30: Programming The Cadd-Plus Pump For Intermittent Delivery

    Programming the CADD-PLUS ® Pump for Intermittent Delivery NOTE: M ak e sure that the pum p is set in the Stop m ode and L ock L evel 0 (Section 3.2). 3.4.1 Selecting the Intermittent Delivery Mode Remove the battery compartment cover and lift the battery at the contact end until the contacts disengage.

  • Page 31: Setting The Reservoir-Residual Volume (Res Vol)

    If the pump is in the Continuous mode, „ • Press the SELECT MODE key to change the pump display from the Continuous mode to the Intermittent mode. ¤ • Press the SET/CLEAR key to enter the Intermittent mode setting into the pump’s memory and to continue the power-up se- quence.
  • Page 32 For example, if you were to program the RES VOL for 75 ml, and actually put 85 ml into the fluid container, the pump would stop its delivery after 75 ml had been delivered. The RES VOL alarm would beep to indicate that the pro- grammed amount had been delivered.

  • Page 33: Setting The Delivery Volume (Ml)

    3.4.3 Setting the Delivery Volume (ML) • Press and release the SELECT MODE key until ML appears on „ the display with a number in the range of 00.0 to 150.0. ´ • Press the SCROLL keys until the desired delivery volume appears on the pump’s display.

  • Page 34: Setting The Delivery Period (Period)

    3.4.4 Setting the Delivery PERIOD (PERIOD) „ • Press and release the SELECT MODE key until HR:MIN and PERIOD appear on the display, with a number in the range of 0:10 to 12:00. ´ • Press the SCROLL keys until the desired PERIOD appears on the pump’s display.

  • Page 35: Setting The Delivery Cycle (Cycle)

    3.4.5 Setting the Delivery CYCLE (CYCLE) • Press and release the SELECT MODE key until HR:MIN and „ CYCLE appear on the display, with a number in the range of 0:20 to 12:10 or 24:00. ´ • Press the SCROLL keys until the desired CYCLE appears on the pump’s display.

  • Page 36: Setting The Delay Start (Delay Start)

    NOTE: If you do not press the SET /CL EA R k ey w ithin 15 seconds, the pum p’s m em ory w ill retain the previous KV O rate. 3.4.7 Setting the DELAY START (DELAY START) „ • Press and release the SELECT MODE key until DELAY START and HR:MIN appear on the display with a number in the range of 0:10 to 12:00, or 0:00.

  • Page 37: Reviewing The Given Mode

    • Press and release the SELECT MODE key until CYCLE GIVEN „ and HR:MIN appear on the display. The number 0:00 will appear on the display if you have changed the pump’s program or DELAY START. A number between 0:00 1: 3 0 STOP and the current delivery CYCLE will appear...

  • Page 38: Attaching And Removing The Cassette

    Attaching and Removing the Cassette 3.5.1 Removing a Used Cassette WARNING: Alw ays close the fluid path tubing w ith the clamp before removing the cassette from the pump to prevent unregulated gravity infusion, w hich could result in death or serious injury to the patient. To remove the cassette, follow these steps: •...

  • Page 39: Attaching The Cassette

    3.5.2 Attaching the Cassette Obtain a new, filled Medication Cassette Reservoir, or CADD Administra- ™ ® tion Set attached to a non-vented fluid container. Refer to the instructions for use supplied with the product for preparing the product for use. •...

  • Page 40: Priming The Cadd-Plus Pump Tubing

    Priming the CADD-PLUS ® Pump Tubing To use the Prime mode, be sure that the pump is in the Stop mode and in either Lock Level 0 (LL0) or Lock Level 1 (LL1). You cannot prime the tubing in Lock Level 2 (LL2).

  • Page 41: Programming The Patient Lock Levels (Ll0, Ll1, And Ll2)

    the entire fluid path is free of all air bubbles. Air embolism could result in death or serious injury to the patient. Programming the Patient Lock Levels (LL0, LL1, and LL2) ® The CADD-PLUS pump has three different lock levels. They appear on the pump’s display as “LL0”, “LL1”, and “LL2”.
  • Page 42 Table 1. Control limits of the CADD-PLUS ® pump. Lock Description Level Use this lock level for programming the pump’s functions. In the Continuous mode, the patient may prime the tubing and reset the RES VOL to the original programmed value. In the Intermittent mode, the patient may program the DELAY START function, prime the tubing, and reset the RES VOL to the original programmed value.
  • Page 43 • Scroll to ´ ** Text omitted from online version ** You should not let the patient know this code, in order to prevent the patient from programming the pump. STOP Œ • Press the LOCK key again to complete the final step in the locking sequence.

  • Page 44: Starting And Stopping The Pump

    Starting and Stopping the Pump To start the pump, follow these steps: ⁄ STEP 1: Press and hold the STOP/START key. Three dashes appear on the display; then they disappear one-by-one. STEP 2: Release the STOP/START key after the last dash disappears, and the pump beeps;...

  • Page 45: Reviewing The Cadd-Plus Programming Modes

    Reviewing the CADD-PLUS ® Programming Modes Drug delivery begins in the Start mode. When the pump is in the Start mode, programming is not possible, but there can be a review of the pump’s program- ming modes. To review each mode in succession, press and release the SELECT MODE key after each mode appears on the display.

  • Page 46: Reference Section

    REFERENCE SECTION Glossary Aspirate. This term refers to the removal of air from the fluid path by suction. ® . A trademark acronym for Computerized Ambulatory Drug Delivery. CADD ® Administration Set. The device that allows the pump to operate with large CADD ®...
  • Page 47 Lock Level. This term refers to a keyboard LOCK setting that restricts the patient’s operation of the pump. You program the pump in Lock Level 0 (LL0); you permit the patient to have some control of drug delivery in Lock Level 1 (LL1); and in Lock Level 2 (LL2), you permit the patient to have only minimal control.

  • Page 48: Pump Maintenance And Cleaning

    Pump Maintenance and Cleaning CAUTIONS: • Do not immerse the pump in cleaning fluid or w ater. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment. • Do not clean the pump w ith acetone, other plastic solvents, or abrasive cleaners. Use any of the following solutions to clean the pump and accessories: •...

  • Page 49: Alarms And Troubleshooting Chart

    Alarms and Troubleshooting Chart The CADD-PLUS pump (Model 5400) has a number of alarms to alert you to ® conditions that require corrective actions. The alarms are audible and can be distinguished as shown in Table 2. Table 2. Alarms/conditions that require corrective actions. Alarm/Condition Cause Corrective Action...
  • Page 50 Table 2— continued . Alarm/Condition Cause Corrective Action All indicators appear on the A power-up fault has oc- • Remove and reinsert the battery; or, display; a continuous, vari- curred, or the battery is • Inser t a battery; or, able-tone alarm sounds.

  • Page 51: The Reservoir-Residual (Res Vol) Volume Alarm

    00.0; PER IO D = 12:00; CY CL E = 12:10; D EL AY STA RT = 00:00; CY CL E G IV EN = 00:00; KV O M L /H R = 00.0; M L G IV EN = 000; R ES V O L = O FF;...

  • Page 52: Specifications (Nominal)

    Specifications (Nominal) 4.5.1 Continuous GIVEN Range 000–999 ml in 1-ml increments rounded down to ..... nearest ml. RES VOL Alarm Range 000–1,500 ml in 1-ml increments rounded up to the ..nearest ml; 000 ml for alarm off. ML/HR Range 0.00–75.0 ml/hr in 00.1-ml increments.

  • Page 53: General

    4.5.3 General Medication Cassette ™ Reservoir Capacity 50 ml or 100 ml....Pump Operating Temperature Range +2°C to 40°C (35°F to 104°F)..... Pump Storage Temperature Range -40°C to 55°C (-40°F to 131°F)..... Pump Humidity Range 10% to 90% Relative Humidity..

  • Page 54: Limited Warranty

    SIMS Deltec, Inc., 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 SIMS Deltec, Inc.
  • Page 56 © 2000 SIMS Deltec, Inc. 19522_2652-01G All rights reserved. 2000-03 Printed in U.S.A. 40-2652-01G...

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