SIMS Deltec CADD-1 5100 HFX User manual

i
Note: Colors are Black
and Cyan (as second color)
Model 5100 HFX
O perator’s Manual
Ambulatory Infusion Pum p
CADD-1
®
Deltec
SIMS Deltec, Inc., St . Pau l, M N 55112 U.S.A.
This online version differs 
from the printed version. 
Certain information that is 
not intended for patients 
has been removed.

ii
This manual pertains only to the Deltec CADD-1®, Model 5100 HFX, infusion
pump.
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. Do not
permit patients to have access to this manual or otherw ise disclose to the patient
the security code of the pump or any information w hich w ould allow the patient
to have complete access to all programming and operating functions.
CADD, CADD-1, Medication Cassette Reservoir and Medication Cassette Reservoir design are SIMS
trademarks.
These products are covered by U. S. Patent Nos. 4,559,038; 4,565,542; 4,650,469 and D294,733;
other patents pending.
DURACELL®is a registered trademark of DURACELL INC. EVEREADY®ENERGIZER®is a registered
trademark of UNION CARBIDE CORP. ULTRALIFE®is a registered trademark of ULTRALIFE
Batteries, Inc.

iii
Technical Assistance
If you have comments or questions concerning the operation of the CADD-1®
pump, please call this number: 800-426-2448.
Our staff is available to help clinicians twenty-four hours a day with the
programming and operation of the CADD-1®infusion pump.
SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, Minnesota 55112 U.S.A.

iv
CONTENTS
1.0 INTRODUCTION ........................................................................ 1
2.0 GENERAL DESCRIPTION OF CADD-1®PUMP
OPERATIONS ............................................................................ 1
2.1 WARNINGS and CAUTIONS ............................................. 2
2.1.1 WARNINGS.............................................................. 2
2.1.2 CAUTIONS............................................................... 3
2.2 Physical Description of the Pump and Accessories ........... 4
2.2.1 Items Packaged with the Pump ............................... 5
2.2.2 Description of the Function Keys and Display
Panel ....................................................................... 5
2.2.3 Description of the Reservoir or Administration
Set ........................................................................... 6
2.3 Understanding the Delivery Modes .................................... 7
2.3.1 Description of the Continuous Rate Mode .............. 7
2.3.2 Description of the High Flow Mode ......................... 7
2.3.3 The Continuous Rate (ML) ...................................... 8
2.3.4 The Milliliters Given (ML GIVEN) ............................ 8
2.3.5 The Reservoir-Residual Volume (RES VOL) .......... 8
3.0 OPERATOR INSTRUCTIONS ................................................... 9
3.1 Installing or Replacing the Battery ..................................... 10
3.2 Preparing to Program the CADD-1®Pump ........................ 13
3.3 Programming the CADD-1®Pump for Continuous Rate
Delivery .............................................................................. 16
3.3.1 Setting the Reservoir-Residual Volume
(RES VOL) .............................................................. 16
3.3.2 Setting the Continuous Rate (ML) ........................... 18
3.3.3 Reviewing the ML GIVEN (ML GIVEN) ................... 19

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3.4 Programming the CADD-1®Pump for High Flow
Delivery .............................................................................. 20
3.5 Attaching and Removing the Cassette ............................... 22
3.5.1 Removing a Used Cassette .................................... 22
3.5.2 Attaching the Cassette ............................................ 23
3.6 Priming the CADD-1®Pump Tubing ................................... 24
3.7 Programming the Patient Lock Levels (LL0, LL1, and
LL2) .................................................................................... 25
3.8 Starting and Stopping the Pump ........................................ 28
3.9 Reviewing the CADD-1®Programming Modes .................. 29
4.0 REFERENCE SECTION ............................................................ 30
4.1 Glossary ............................................................................. 30
4.2 Pump Maintenance and Cleaning ...................................... 32
4.3 Equipment Exposure to Radiation or Magnetic Resonance
Imaging (MRI) .................................................................... 32
4.4 Alarms and Troubleshooting Chart .................................... 33
4.4.1 The Reservoir-Residual (RES VOL) Volume
Alarm ....................................................................... 35
4.4.2 The High Pressure (HI P) Alarm .............................. 35
4.5 Specifications (Nominal) .................................................... 36
4.5.1 Programming Specifications ................................... 36
4.5.2 General Specifications ............................................ 36
4.6 Limited Warranty ................................................................ 38

vi

1
Description
1.0 INTRODUCTION
The Deltec CADD-1®pump provides measured drug therapy to patients in
hospital or outpatient settings. H ealthcare professionals should use this manual
to learn how to operate the pump.
The purpose of this manual is to familiarize you with the CADD-1®pump’s
functions, which are described in Section 2; and to instruct you in how to use
those functions, which are outlined in detail in Section 3. Section 4 is a reference.
2.0 GENERAL DESCRIPTION OF CADD-1®PUMP
OPERATIONS
The CADD-1®M odel 5100 H FX ambulatory drug delivery pump is indicated
for intravenous, intra-arterial, or subcutaneous infusion (excluding insulin).
Therapy should always be overseen by a physician or a certified, licensed healthcare
professional. The patient should be instructed in using and troubleshooting the
pump.
The pump’s flexibility in programming allows it to be used in a variety of settings,
including the home. The pump provides continuous delivery of medication.
• You can program the pump to deliver medication at a constant rate in
milliliters per 24-hour period.
• You may also select the High Flow Mode. H igh Flow delivery provides a rate
of approximately 90 ml/hr.

2
Description
2.1 WARNINGS and CAUTIONS
Read this entire Operator’s Manual before operating the CADD-1®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.
• Use only drugs and solutions which are stable under delivery conditions experienced
during use in the pump. O bserve warnings packaged with the M edication Cassette™
Reservoir or CADD®Administration Set.
• Do not use the pump in the presence of flammable anesthetics or explosive gases.
• The pump does not have an air-in-line alarm, an air entrapment mechanism, or an
upstream occlusion detector mechanism. Periodic visual inspection is therefore
recommended.
• Back-pressure or fluid resistance, which depends upon drug viscosity and catheter
size, may result in system delivery inaccuracies.
• Only the CADD®Extension Set with Anti-Siphon Valve must be used with this
pump; other extension sets will result in system delivery inaccuracies.
• This pump is capable of being set at a residual volume higher than the capacity of
the fluid container. The reservoir-residual volume value should be programmed to
reflect the actual volume of the medication being used.
• Avoid dropping the pump or hitting the pump against a hard surface, as this could
cause the cassette to become detached and the battery cover to become detached
or loose. If the cassette becomes detached, an uncontrolled flow of medication
from the fluid container or a reflux of blood may result, which could result in
death or serious injury to the patient. If the battery door becomes detached or
loose, the battery 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.
• If the pump is dropped or hit, inspect the pump to ensure that the cassette did not
become detached and the battery cover did not become dislodged. Inspection
should include closing the clamp on the tubing, detaching the pump and inspecting
the hinges, and checking the clips on the battery door to ensure they are not
broken. If there appears to be damage, the patient should be instructed to immediately
contact his or her health care provider, the pump should be taken out of service,
and Deltec’s Customer Service department should be contacted for return
authorization. If there appears to be no damage, reattach the cassette following
the instructions in the O perator’s M anual.

3
Description
• 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 O n Anti-Siphon Valve.
• Use of a syringe with the CADD®Administration Set may result in UN DER-
DELIVERY of medication. Syringe function can be adversely affected by variations
in plunger dimension and lubricity, which can result in greater force being r equired
to move the plunger. A syringe will lose plunger lubrication as it ages and, as a
result, the amount of under-deliver y will increase which could, on occasion, be
significant. Therefore, the type of medication therapy and delivery accuracy required
must be considered when using a syringe with the CADD®pump.
Clinicians must regularly compare the volume remaining in the syringe to the
pump’s displayed values such as RES VOL and GIVEN in order to determine
whether under-deliver y of medication is occurring and, if necessar y, take appropriate
action.
2.1.2 CAUTIONS
• This device is not intended to be used for delivery of blood or cellular blood
products.
• This device may interfere with ECG equipment. Monitor ECG equipment carefully
when using this device.
• The pump is not sterile. It is not designed to be sterilized. Sterilization could
damage the microcomputer and other pump parts.
• The pump should be routinely cleaned and kept free of dirt, liquids, and foreign
objects.
• Do not store the pump at temperatures below -40°C (-40°F ) or above 55°C
(131°F).
• Do not operate the pump at temperatures below +2°C (35°F) or above 40°C
(104°F).
• Do not expose the pump to humidity levels above 90% R. H .
• The pump is water resistant. H owever, total immersion is not recommended be-
cause moisture buildup within the case may damage the parts. Do not use pump
in the shower, sauna, or steam bath.
• Do not store the pump for prolonged periods with a battery; the battery could
leak and damage the pump.
• Avoid using the pump in close proximity to sources of strong static electricity or
strong electromagnetic fields.
• The use of a Deltec Pump Pouch is recommended. If the pump is dropped or
inadvertently hit against a hard surface, the pump pouch is designed to minimize
the need for servicing.

4
Description
2.2 Physical Description of the Pump and Accessories
The following diagram, Figure 1, illustrates the CADD-1®pump and its major
functions.
Figure 1. The CADD-1®pump.
ML
LO BAT
RES VOL
RATE
GIVEN
STOP
CADD-1®
Rate is in
l/24 hrs
Display (LCD)
Keyboard
Scroll Keys
Cassette (the part of the
Medication Cassette™ Res-
ervoir or CADD® Ad inis-
tration Set that attaches to
the pu p)
®

5
Description
2.2.1 Items Packaged with the Pump
Packaged with the pump are the following accessories:
1 Battery (9-volt)
1 50 ml M edication Cassette™Reservoir (non-sterile, for demonstration
only)
1 Carrying case
1 Carrying pouch
1 Operator’s M anual with warranty information
The following products are also compatible with the CADD-1®pump:
• Medication Cassette™Reservoir (50- or 100-ml), to be used with the
Extension Set with Anti-Siphon Valve
• CADD®Administration Set with integrated or Add O n Anti-Siphon
Valve
• Pump Pouches
2.2.2 Description of the Function Keys and Display Panel
Liquid Crystal Display (LCD). This is the pump’s display panel; the screen
which shows the pump’s various functions or modes and the values you program
for them. In this manual, the term “ display” is synonymous with display panel
or LCD.
STO P/START Key. Press and hold the STOP/START key to start or stop pump
delivery.
SET/CLEAR Key. Use the SET/CLEAR key for programming, setting or resetting,
and clearing of numbers in the computer’s memory.
PRIME Key. Use the PRIME key to fill the tubing and to remove air bubbles
from the fluid path.
LO CK Key. Use the LO CK key to lock out or limit the patient’s operation of the
pump.
SELECT MO DE Key. Use the SELECT M ODE key to view the various modes,
such as the Continuous Rate and RES VO L modes. When the pump is in the
Stop or Start mode, and you press and release the SELECT M O DE key, the
pump will display each mode in succession. You will have to press the SELECT
MODE key each time you wish to access another mode. (See Section 3.9,
“Reviewing the CADD-1®Programming Modes” .)
SCRO LL Keys. Use the up or down SCROLL keys to increase or decrease the
numeric value shown on the pump’s display.

6
Description
2.2.3 Description of the Medication Cassette™Reservoir or
CADD®Administration Set
The CADD-1®pump may use a detachable, single use Medication Cassette™
Reservoir for holding the drug. They are available in 50 ml and 100 ml sizes.
A CADD®Administration Set may also be used to deliver medication from IV
bags of various sizes.
The procedures for attaching and removing the cassette (the part of the Medication
Cassette™Reservoir or CADD®Administration Set that attaches to the pump)
are located in Section 3.
Figure 2. Discard a used Medication Cassette™Reservoir or CADD®
Administration Set immediately.
LOCKED
®

7
Description
2.3 Understanding the Delivery Modes
This section introduces the three delivery modes that appear on the CADD-1®
HFX pump display: (1) the Continuous Rate (M L) M ode; (2) the M illiliters
Given (ML GIVEN ) M ode; and (3) the Reservoir-Residual Volume (RES VOL)
Mode. Further details concerning these delivery modes are introduced in Section
3.3, “Programming the CADD-1®Pump for Continuous Rate Delivery.”
2.3.1 Description of the Continuous Rate Mode
Programming the pump in the Continuous Rate Mode permits a steady infusion
rate. (See Figure 3.) In this mode, you can program the pump to deliver medication
at a constant rate in milliliters per 24-hour period.
2.3.2 Description of the High Flow Mode
You may also select the High Flow Mode. H igh Flow delivery provides a rate of
approximately 90 ml/hr.
Figure 3. The Continuous Rate Mode.
Time (24-hour period)
Delivery
Volum e
(ML)

8
Description
2.3.3 The Continuous Rate (ML)
The delivery rate in M L (milliliters in a 24-hour period) is the constant rate at
which the pump delivers medication. The delivery rate range is from 1 ml to 299
ml/24 hours in 1 ml increments. If you program a delivery rate of 000 ml,
delivery will not occur.
2.3.4 The Milliliters Given (ML GIVEN)
The M L GIVEN refers to the number of milliliters delivered since the M L GIVEN
register was last cleared.
The number of milliliters in M L GIVEN accumulates from 000 to 999 and then
automatically resets to 000. Please note that the M L GIVEN counter functions
in a way that is similar to your automobile’s odometer. After the M L GIVEN
counter reaches 999, it will start at 000 again and continue counting.
2.3.5 The Reservoir-Residual Volume (RES VOL)
The Reservoir-Residual Volume (RES VO L) refers to the initial amount of
medication (in milliliters), contained in the fluid container, that you wish to
deliver. You must enter that amount into the computer’s memory to determine
the amount of medication remaining in the fluid container. [See Section 3.3.1,
“Setting the Reservoir-Residual Volume (RES VO L)”.]

9
Operating Instructions
3.0 OPERATOR INSTRUCTIONS
This section describes how to operate the CADD-1®pump. It contains detailed,
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)
• Setting the reser voir-residual volume ................................. (Section 3.3.1)
• Setting the continuous rate ................................................ (Section 3.3.2)
• Programming for H igh Flow delivery ................................... (Section 3.4)
• Attaching the Cassette ....................................................... (Section 3.5.2)
• Priming the tubing ............................................................... (Section 3.6)
• Setting the lock levels (LL0, LL1, or LL2) ............................ (Section 3.7)
• Starting and stopping the pump ........................................... (Section 3.8)
• Reviewing the CADD-1®programming modes ..................... (Section 3.9)

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Operating Instructions
3.1 Installing or Replacing the Battery
Use a new, 9-volt alkaline or lithium battery to power the pump. (See Section
4.5.2, “ 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. They do not provide sufficient pow er
for the pump to operate properly, w hich could result in death or serious injury
to the patient.
• Alw ays have new batteries available for replacement. If pow er is lost, non-
delivery of drug, and, depending on the type of drug being administered, death
or serious injury to the patient could result.
• There is no pump alarm to alert users that the battery
has not been properly installed or has become dislodged.
An improperly installed or dislodged battery could
result in loss of pow er and non-delivery of drug 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 w ill not be
properly secured; this may result in loss of power, non-delivery of drug, and,
depending on the type of drug being administered, death or serious injury to the
patient.
As soon as you install the battery, the pump will be
on; there is no O n/O ff switch. In order to install or
replace a battery, be sure to place the pump in the
Stop mode. Then, follow these steps:
STEP 1: Push down and hold the battery door release
button while sliding the door off.
STEP 2: Remove the used battery.
STEP 3: Install the battery in the compartment (bottom-
end first).
11/04/96 D. Zurn
«Remove Batt 11/96»
11/04/96 D. Zurn
«Batt Compart Tabs 11/96»
11/26/96
D. Zurn
«Open
Locking
Door
11/96»

11
Operating Instructions
NOTE:
Be sure to match the polarity m ark ings of the new
battery (+ and –) with those on the battery
compartm ent. If you put the battery in back wards,
the display panel w ill be blank, and you w ill not hear
a beeping sound.
Use a new, 9-volt alkaline or lithium battery to power
the pump. You may use any alkaline battery, including
DURACELL®Alkaline MN 1604 and EVEREADY®
ENERGIZ ER®Alkaline #522, for example; or, use
the ULTRALIFE®Lithium U9VL batter y. You may
also use an external power source to run the pump.
STEP 4: Place the battery doorhalfway overthe battery
compartment and press the battery into the
compartment by pushing down on top of the
door with your thumb.
STEP 5: Slide the door closed. Ensure that the door is
latched by trying to remove the door without
pressing the release button.
WARNING:
If a gap is present anyw here betw een 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 pow er,
nondelivery of drug, and, depending on the type of drug being administered,
death or serious injury to the patient.
The power up sequence will start, and the pump will go through an electronic
self-test, which lasts about 50 seconds. All of the display indicators and the
software revision level will appear briefly.
11/04/96 D. Zurn
«Match Batt 11/96»
11/26/96
D. Zurn
Close
Locking
Door
11/96

12
Operating Instructions
STEP 6: Begin operation of the current program by pressing and holding the
STOP/START key to enter the Start mode (Section 3.8), or proceed to
Section 3.2 to program the pump.
NOTE:
You w ill not be able to change the delivery rate until the infusion period has been
completed, unless you stop the pum p and reprogram in L ock L evel 0.
The battery’s life is dependent on the amount of medication delivered and the
temperature. At the infusion rate of one 50 ml M edication Cassette™Reservoir
per day, an alkaline battery will usually last about seven days. If you use an
ULTRALIFE®lithium battery, you will have power for approximately ten days.
Be sure to stop the pump before removing the battery, or up to 10 ml of solution
may not be accounted for by the ML GIVEN function. A battery’s power will be
quickly depleted at temperatures below +10°C (50°F).
CAUTION:
Do not store the pump for prolonged periods of time w ith the battery installed.
Battery leakage could damage the pump.

13
Operating Instructions
*STOP
---
⁄
3.2 Preparing to Program the CADD-1®Pump
The CADD-1®pump must be in Lock Level 0 (LL0) in order to program the
pump.
You will need to perfor m three steps to ensur e that the pump is in Lock Level 0
(LL0):
1. Make sure that the pump is in the Stop mode.
2. Determine the current lock level of the pump.
3. Change the lock level to Lock Level 0 (LL0)
When the pump is set at LL0, you are ready to turn to Section 3.3, “Programming
the CADD-1®Pump.” Section 3.6, “Programming the Patient Lock Levels (LL0,
LL1, and LL2)” provides more information about the pump’s lock levels.
NOTE:
W hile you are using the L O CK k ey, you m ust proceed to the nex t step in the
sequence w ithin 15 seconds. If you do not perform the nex t step w ithin
15 seconds, the pum p will retain the previous setting.
STEP 1: Make sure the pump is in the Stop mode.
When the pump is in the Stop mode, the word
“STO P” flashes in the lower left corner of the
display, and you will hear three beeps ever y
5 minutes. If the pump is in the Stop mode, go to
Step 2.
• Press and hold the STO P/START key.
You will hear a single beep, and three dashes will
appear one-by-one on the pump’s display.
• Release the STO P/START key after the third dash appears and you hear a
second beep.

14
Operating Instructions
STEP 2:Determine the current lock level of the pump.
•Press and release the LO CK key.
This example shows that the pump is in Lock
Level 1.
STEP 3:Change the lock level to Lock Level 0 (LL0).
•Press the up or down SCRO LL key until LL0 appears on the
display.
•Press the LO CK key.
The display shows “ 000.”
•Press the up SCRO LL key (** text omitted from online version**)
on the pump’s display.
NOTE:
(** 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
LL1
*STOP
LL0
STOP
*
STOP
000
*
Œ
Œ
´
´
Î