SIMS Deltec CADD-Legacy PLUS User manual

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PROOF (LR #3086), 2000-03-15 «3934-51D Cover, Legacy PLUS»
CONTINUOUS OR INTERMITTENT
DELIVERY
This Operator’s Manual is for clinician use only.
Read the entire Operator’s Manual before
operating the pump.
CADD-Legacy™PLUS
Ambulatory Infusion Pump
Model 6500
SIMS DELTEC, INC.
OPERATOR’S MANUAL
3934-51D Cover, Legacy PLUS 12/7/00, 11:23 AM1
This online version differs
from the printed version.
Certain information that is
not intended for patients has
been removed.
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PROOF (LR #3086), 2000-03-15 «3934-51D Cover, Legacy PLUS»
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 informa-
tion 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 [phone]
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.
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PROOF (LR #3086), 2000-03-15 «3934-51D Cover, Legacy PLUS»
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 informa-
tion 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 medi-
cation 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 lubric-
ity, 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
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syringe to the pump’s displayed values such as RES VOL and
GIVEN in order to determine whether under-delivery of medica-
tion 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™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.
• 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.
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• 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 prop-
erly.
• 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 prop-
erly 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 Cas-
sette™Reservoir, or cause leakage.
• Attach the cassette (the part of the Medication Cassette™Reser-
voir 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.
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• 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™Reservoir or CADD®Administration Set attached. Use
the Protective Cassette provided.
• Do not expose the pump to humidity levels below 20% or above
90% relative humidity.
• 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 radia-
tion.
• Do not expose the pump directly to ultrasound.
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PROOF (LR #3086), 2000-03-15 «3934-51D Cover, Legacy PLUS»
• 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.
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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
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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
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1
General
Description
Section 1: General Description
PROOF (LR #3086), 2000-03-15 «3934-51D Manual, Legacy PLUS»
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, intra-
arterial, subcutaneous, intraperitoneal, epidural space, or subarach-
noid 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. Administra-
tion of any drug by this pump is limited by any warnings, precau-
tions, or contraindications in the drug labeling.
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.
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General
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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
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.
• To prevent the infusion of drugs that are not indicated for
epidural space or subarachnoid space infusion, do not use ad-
ministration 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.
• If a Medication Cassette™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.
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General
Description
Section 1: General Description
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Symbols
~Alternating Current (Power Jack)
OAccessory Jack
!Attention, consult accompanying documents
(read Instructions for Use)
KClass II Equipment
JType CF Equipment
ESplashproof – water splashed against pump housing will
have no harmful effects (see Cleaning the Pump and
Accessories, Section 5, for additional important informa-
tion)
DDate 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.
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General
Description
Section 1: General Description
PROOF (LR #3086), 2000-03-15 «3934-51D Manual, Legacy PLUS»
Pump Diagram
Display
Power Jack
Accessory Jack
AC Indicator
Light
Air Detector
Keypad
Cassette
Front
View
Threaded
Mounting
Hole
Battery
Compartment
Cassette Lock
Power Jack
symbol
Accessory
Jack symbol
Rear
View
®
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General
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Section 1: General Description
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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).
‹is used to fill the tubing and to remove air bubbles from the
fluid path.
Œis 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.
Îallows you to “scroll down”or decrease a value, or scroll
through Biomed Function settings.
Åis used to put the pump into a low power state when not in
use or back into full power.
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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
supplied with those accessories.
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™Reservoir (50 or 100 ml), used with
the CADD®Extension Set with Anti-Siphon Valve
•CADD®Administration Set with integral Anti-Siphon Valve
•CADD®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
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7
General
Description
Section 1: General Description
PROOF (LR #3086), 2000-03-15 «3934-51D Manual, Legacy PLUS»
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 batter-
ies 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.
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 up-
stream 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 decreas-
ing 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
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General
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Section 1: General Description
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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.”
Reservoir Volume Alarm: The Reservoir Volume alarm indicates
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.
When running:
Status of pump
Reservoir Volume
Battery Status
Status of Reservoir
Volume
RUN LowBat
ResVol 50.0 ml
When stopped:
Status of pump
STOPPED
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General
Description
Section 1: General Description
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Lock Levels
Lock levels are used to limit patient access to certain programming
and operating functions. The table on the next page lists the func-
tions 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:
** text omitted from online version **
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 operat-
ing functions. Improper programming could result in death
or serious injury to the patient.
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10
General
Description
Section 1: General Description
PROOF (LR #3086), 2000-03-15 «3934-51D Manual, Legacy PLUS»
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
Mode = IDM
Pump Operations Stopped Running
and Programming LL0 LL1 LL2 Any
Lock Level
Stop/Start the pump Yes Yes Yes Yes
Reset Reservoir Volume Yes Yes Yes No
Prime Yes Yes No No
Change the lock level Yes, w/code Yes, w/code Yes, w/code No
Change Continuous Rate Yes Up to LL0 value No No
(CDM)*
Clear Given amount Yes Yes No No
(CDM & IDM)*
Change Dose Volume Yes No No No
(IDM)*
Change Dose Duration Yes No No No
(IDM)*
Change Dose Cycle (IDM)* Yes No No No
Change KVO Rate (IDM)* Yes No No No
Change Dose Starts in Yes Yes No No
delay (IDM)*
Biomed Functions
Access to Functions Yes, w/code No No No
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
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