SIMS Deltec CADD-PLUS 5400 Manuel utilisateur
i
Note: Colors are Black
and Cyan (as second color)
Model 5400
O perator’s Manual
Am bulatory Infusion Pum p
CADD-PLUS®
Deltec
SIM S D e lt e c, In c., St . Pau l , M N 5511 2 U .S.A.
This online version differs
from the printed version.
Certain information that
is not intended for patients
has been removed.
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CADD, CADD-PLUS, 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 regis-
tered trademark of Union Carbide Corp. ULTRALIFE®is a registered trademark of ULTRALIFE
Batteries, Inc.
This manual pertains only to the Deltec CADD-PLUS®, Model 5400, 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 otherwise disclose to the patient
the security code of the pump or any information w hich would allow the patient
to have complete access to all programming and operating functions.
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TECHNICAL ASSISTANCE
If you have comments or questions concerning the operation of the CADD-PLUS®
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-PLUS®infusion pump.
SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, Minnesota 55112 U.S.A.
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CONTENTS
1.0 INTRODUCTION ................................................................................... 1
2.0 GENERAL DESCRIPTION OF CADD-PLUS®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
2.4 Description of the Continuous Delivery Mode .............................. 7
2.4.1 The Reservoir-Residual Volume (RES VOL) .................... 7
2.4.2 Continuous Rate (ML/HR) ................................................. 8
2.4.3 The Amount GIVEN (GIVEN) ........................................... 8
2.5 Description of the Intermittent Delivery Mode ............................... 8
2.5.1 The Reservoir-Residual Volume (RES VOL) .................... 9
2.5.2 The Delivery Volume (ML) ................................................. 9
2.5.3 The Delivery PERIOD (PERIOD) ...................................... 9
2.5.4 The Delivery CYCLE (CYCLE) .......................................... 10
2.5.5 The KEEP VEIN OPEN (KVO) Rate ................................. 10
2.5.6 The DELAY START Function (DELAY START) ................ 10
2.5.7 The CYCLE GIVEN (CYCLE GIVEN) ............................... 11
2.5.8 The Amount GIVEN (GIVEN) ........................................... 11
3.0 OPERATOR INSTRCTIONS ................................................................. 12
3.1 Installing or Replacing the Battery ................................................ 13
3.2 Preparing to Program the CADD-PLUS®Pump ........................... 16
3.3 Programming the CADD-PLUS®Pump for Continuous Delivery .. 19
3.3.1 Selecting the Continuous Delivery Mode .......................... 19
3.3.2 Setting the Reservoir-Residual Volume (RES VOL) ......... 20
3.3.3 Setting the Continuous Delivery Rate (ML/HR) ................. 22
3.3.4 Reviewing the GIVEN Mode .............................................. 23
3.4 Programming the CADD-PLUS®Pump for Intermittent Delivery .. 24
3.4.1 Selecting the Intermittent Delivery Mode ........................... 24
3.4.2 Setting the Reservoir-Residual Volume (RES VOL) ......... 25
3.4.3 Setting the Delivery Volume (ML) ...................................... 27
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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 .............................................. 31
3.5 Attaching and Removing the Cassette ......................................... 32
3.5.1 Removing a Used Cassette ............................................... 32
3.5.2 Attaching the Cassette ...................................................... 33
3.6 Priming the CADD-PLUS®Pump Tubing ...................................... 34
3.7 Programming the Patient Lock Levels (LL0, LL1, and LL2) ......... 35
3.8 Starting and Stopping the Pump .................................................. 38
3.9 Reviewing the CADD-PLUS®Programming Modes ..................... 39
4.0 REFERENCE SECTION ....................................................................... 40
4.1 Glossary ....................................................................................... 40
4.2 Pump Maintenance and Cleaning ................................................ 42
4.3 Equipment Exposure to Radiation or Magnetic Resonance
Imaging (MRI) ............................................................................... 42
4.4 Alarms and Troubleshooting Chart ............................................... 43
4.4.1 The Reservoir-Residual (RES VOL) Volume Alarm .......... 45
4.4.2 The High Pressure (HI P) Alarm ........................................ 45
4.5 Specifications (Nominal) ............................................................... 46
4.5.1 Continuous ........................................................................ 46
4.5.2 Intermittent ........................................................................ 46
4.5.3 General ............................................................................. 47
4.6 Limited Warranty .......................................................................... 48
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1
Description
1.0 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; and to instruct you in how to use
those functions, which are outlined in detail in Section 3. Section 4 is a refer-
ence.
2.0 GENERAL DESCRIPTION OF CADD-PLUS®PUMP
OPERATIONS
The CADD-PLUS®Model 5400 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 set-
tings, including the home. The clinician may program the pump in either of two
modes: the Continuous mode or the Intermittent mode. In the Continuous mode,
the pump delivers medication at a constant rate; in the Intermittent mode, it
delivers medication at regular, preset intervals.
Description
2
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.
•Use only drugs and solutions which are stable under delivery conditions experi-
enced during use in the pump. Observe warnings packaged with the Medication
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 inspect-
ing 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 imme-
diately 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 Operator’s Manual.
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 On Anti-Siphon Valve.
•Use of a syringe with the CADD®Administration Set may result in UNDER-
DELIVERY of medication. Syringe function can be adversely affected by varia-
tions in plunger dimension and lubricity, which can result in greater force being
required to move the plunger. A syringe will lose plunger lubrication as it ages
and, as a result, the amount of under-delivery will increase which could, on occa-
sion, be significant. Therefore, the type of medication therapy and delivery accu-
racy 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-delivery of medication is occurring and, if necessary, take appro-
priate 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 care-
fully 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. However, 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.
Description
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2.2 Physical Description of the Pump and Accessories
The following diagram, Figure 1, illustrates the CADD-PLUS®pump and its
major functions.
Figure 1. The CADD-PLUS®pump.
STOP
START
LO K SELE T
MODE
SET
LEAR
STOP
GIVEN
LO BAT
RES VOL
ML/HR
DELAY
START
PERIOD
CYCLE
KVO HR MIN
CADD-PLUS
®
08/25/94 D. Zurn “PLUS w/4 callouts”
PRIME
Display (L D)
Keyboard
Scroll Keys
assette (the part of the
Medication assette™ Res-
ervoir or ADD® Adminis-
tration Set that attaches to
the pump)
®
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