OPERATOR’S MANUAL
This online version differs from
the printed version.
Certain information that is not intended
for patients has been removed.
OPERATOR’S MANUAL
h
PCS
Model 6100 and 6101 Ambulatory Infusion Pump
/
Pain Control System
This manual concerns only the CADD-Prizm® PCS (Pain Control System)
Model 6100 and 6101 ambulatory infusion pumps. This pump can be programmed to deliver medication at a constant rate and/or allow delivery of a
bolus dose at a specified time 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 for the clinician’s information. In the event one year has elapsed between the issue date and product use,
the clinician should contact Smiths Medical MD, 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 CADDPrizm® PCS pump, please call the number given below. When calling, please
specify the pump’s software module. This information is located in the pump’s
start-up screen.
Our staff at Smiths Medical MD is available to help clinicians twenty-four
®
hours a day with the programming and operation of the CADD-Prizm
PCS
infusion system.
Smiths Medical MD, Inc.
1265 Grey Fox Road
St. Paul, Minnesota 55112 U.S.A.
1 800.426.2448
+1 651.633.2556
www.smiths-medical.com
ii
Read this entire Operator’s Manual before operating the CADD-Prizm® PCS
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
DER-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.
™
Administration Set may result in UN-
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 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).
iii
• Do not administer drugs to the epidural space or subarachnoid space
unless the drug is indicated for those spaces.
• To prevent the 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 epidural space or subarachnoid space drug
delivery, it is strongly recommended that it be clearly differentiated from
those used for other routes of infusion, for example, by color coding, or
other means of identification.
• When the Air Detector is not installed, or is installed but turned off, the
pump will not detect air in the fluid path. It is recommended that you
periodically inspect the fluid path and remove any air to prevent air
embolism.
• Follow the Instructions for Use provided with the Medication Cassette
Reservoir and CADD
™
Extension Set, or the CADD™ Administration Set,
paying particular attention to all warnings and cautions associated with
their use.
• When the Upstream Occlusion Sensor is turned Off, the pump will not
detect occlusions upstream (between pump and fluid container). It is
recommended that you periodically inspect the fluid path for kinks, a
closed clamp, or other upstream obstructions. Upstream occlusions may
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.
• Ensure that the ±6% System Delivery Accuracy specification is taken into
account when programming the pump and/or filling the Medication
Cassette Reservoir. Failure to do so may result in medication in the reservoir becoming depleted sooner than expected.
• 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, nondelivery of drug will occur.
iv
• There is no pump alarm to alert users that a battery has not been properly
installed or has become dislodged. An improperly installed or dislodged
battery could result in loss of power and non-delivery of drug.
• If the pump is dropped or hit, the battery door may become broken or
damaged. Do not use the pump if the battery door is damaged because the
battery will not be properly secured; this may result in loss of power or
non-delivery of drug.
• When you enter a new Demand Dose Lockout time, any lockout time in
effect will be cleared. A Demand Dose could be requested and delivered
immediately upon starting the pump, resulting in over-delivery.
• When you enter a new Max Doses per Hour value, any lockout time in
effect will be cleared. A Demand Dose could be requested and delivered
immediately upon starting the pump, resulting in over-delivery.
• Exercise care when using the Clinician Bolus function. Since there are no
limits on the frequency of delivering a bolus, and since the amount of the
bolus can be set as high as 20 ml (or the mg or mcg equivalent), you
should not permit the patient to become familiar with the procedure for
giving a Clinician Bolus.
• To prevent the patient from accessing the Clinician Bolus function, do not
let the patient know the Clinician Bolus code.
• Always close the fluid path tubing with the clamp before removing the
cassette from the pump to prevent unregulated gravity infusion.
• Attach the cassette properly. A detached or improperly attached cassette
could result in unregulated gravity infusion of medication from the fluid
container or a reflux of blood.
If you are using a Deltec administration set or medication cassette
reservor that does not have the flow stop feature (reorder number does
not start with 21-73xx): you must use a CADD
™
Extension Set with antisiphon 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.
• Do not prime the fluid path with the tubing connected to a patient as this could result in over-delivery 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.
• If Demand Doses are currently locked out, changing the Date and/or Time
v
will cancel the lockout period. This will allow a Demand Dose to be
requested and delivered as soon as you restart the pump, resulting in overdelivery.
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 a Medication Cassette Reservoir or
CADD
• Do not expose the pump to humidity levels below 10% or above 90%
relative humidity.
• Do not store the pump for prolonged periods with the battery installed.
Battery leakage could damage the pump.
• If you are using a Medication Cassette Reservoir in which the medication
is frozen, thaw at room temperature only. Do not heat in a microwave
oven as this may damage the product and cause leakage.
• 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, Data In/Out jack, Power jack or Air Detector port area.
Moisture build-up inside the pump may damage the pump.
™
Administration Set attached.
• Do not clean the pump with acetone, other plastic solvents, or abrasive
cleaners, as damage to the pump may occur.
• 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
vi
the operation of the equipment. Monitor ECG equipment carefully when
using this pump.
• Do not sterilize the pump.
• Do not use the pump in the presence of flammable anesthetics or explosive
gases.
• Use only Smiths Medical MD accessories as using other brands may
adversely affect the operation of the pump.
• Check appropriate medication stability for time and temperature to assure
stability with actual pump delivery conditions.
SYMBOLS
Collect Separately
CAUTION: Federal (USA) law restricts this device to sale by or on
the order of a physician.
vii
Table of Contents
Warnings iii
Cautions vi
Section 1: General Description 1
Introduction ......................................................................................... 1
Indications ........................................................................................... 1
Epidural/Subarachnoid Administration ................................................ 1
Pump Diagram .................................................................................... 3
Description of Keys, Display and Features .......................................... 4
The Main Screen ................................................................................. 8
Getting Help Using the
Lock Levels ......................................................................................... 10
AutoLock ...................................................................................... 10
Security Codes .............................................................................. 10
Customizing the Security Codes .................................................... 10
Lock Level Table ................................................................................. 11
Section 2: Pump Setup and Programming 13
Installing the Battery ........................................................................... 13
Watching Power Up ............................................................................ 15
Changing to Lock Level 0 (LL0) ......................................................... 16
Programming the Pump: General Instructions ..................................... 17
PCA Delivery Method .......................................................................... 18
PCA Programming Screens .................................................................. 19
PCA Programming Example ................................................................ 24
Removing a Cassette ........................................................................... 30
Attaching a Cassette ............................................................................ 31
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
Starting the Pump ................................................................................ 39
Programming with Upper Limits, Adjusting Doses in Lock Level 1 ..... 40
Key ........................................................ 9
Å
Section 3: Operating the Pump 41
Stopping the Pump .............................................................................. 41
Starting the Pump ................................................................................ 41
Starting a Clinician Bolus .................................................................... 43
Starting a Demand Dose ..................................................................... 45
Stopping a Demand Dose or Clinician Bolus ........................................ 46
viii
Resetting the Reservoir Volume .......................................................... 47
Section 4: Options 49
Overview: Accessing Options .............................................................. 49
Prime .................................................................................................. 50
Extended History, Viewing .................................................................. 51
AutoLock ............................................................................................ 53
Time ................................................................................................... 54
Date .................................................................................................... 55
Air Detector On/Off ............................................................................ 56
Event Log, Viewing ............................................................................. 57
Section 5: Biomed Toolbox 59
Overview: Accessing the Biomed Toolbox ........................................... 59
Micrograms On/Off ............................................................................ 60
Custom Concentrations ...................................................................... 60
Extended History On/Off ................................................................... 62
Max Doses Per Hour On/Off ................................................................ 62
PM (Preventive Maintenance) Reminder ............................................. 63
Custom Lock Level Code .................................................................... 63
Date Format ........................................................................................ 64
Power Source Status Display ................................................................ 65
Upstream Sensor On/Off (Model 6101 only) ....................................... 65
Air Detector Requirement ................................................................... 66
Description
General
Programming
Setup &
Operating
the Pump
Options
Section 6: Reference & Troubleshooting 67
Troubleshooting .................................................................................. 67
Alarms and Messages, Alphabetical List ............................................. 69
Cleaning the Pump and Accessories .................................................... 77
Cleaning the Battery Contacts ........................................................... 78
Exposure to Radiation or Magnetic Resonance Imaging (MRI) .......... 79
Continuous Rate Scroll Ranges ........................................................... 80
Demand Dose, Clinician Bolus Scroll Ranges: Milliliters ..................... 80
Demand Dose, Clinician Bolus Scroll Ranges: Milligrams ................... 81
Demand Dose, Clinician Bolus Scroll Ranges: Micrograms ................. 82
Military Time Conversion Chart ......................................................... 83
Specifications (Nominal) ..................................................................... 84
Printing Reports ................................................................................... 87
Index 88
Limited Warranty 91
ix
Toolbox
Biomed
Troubleshooting
Reference &
x
Section 1: General Description
Section 1: General Description
Introduction
The CADD-Prizm® PCS (Pain Control System) ambulatory infusion system
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, the patient should be instructed in
using the pump.
Indications
The CADD-Prizm® PCS pump is indicated for intravenous, subcutaneous, epidural space, or subarachnoid space infusion. The pump is intended for therapies
that require a continuous rate of infusion, patient-controlled demand doses, or
both (such as patient-controlled analgesia).
Description
General
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.
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.
Anesthetics
Administration of anesthetics to the epidural space is limited to use with
indwelling catheters specifically indicated for short-term drug delivery.
1
General
Description
Section 1: General Description
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 administration sets that incorporate injection sites. The inadvertent use of injection sites for infusion of such
drugs may cause death or serious injury to the patient.
• If a Medication Cassette Reservoir, CADD
™
Extension Set or CADD
™
Administration Set is used for epidural space or subarachnoid space drug
delivery, it is strongly recommended that it be clearly differentiated 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.
2
Pump Diagram
Keypad
Power jack
Data In/Out
Air Detector
Port Cover
Display
jack
Indicator Lights
Amber Green
Section 1: General Description
Front View
Description
General
Air Detector
(optional)
Polemount
Bracket
Recess
Battery
compartment
Cassette
lock
Cassette
latch
Cassette
®
2000-03-07 D. Zurn
«Prizm Rear 3/4 (dark BW)»
Rear View
®
3
Section 1: General Description
Description of Keys, Display and Features
General
Description
Indicator Lights
Green: The green light blinks approximately every 3 seconds when the pump is
running and delivering fluid as programmed.
Amber: The amber light flashes when the pump is stopped or an alarm condition exists. It stays on continuously when the pump is inoperable. The display
briefly describes the condition.
If both lights blink, delivery is still occurring but a condition exists of which
you should be aware (for example, a low battery). Look at the display for a
brief description of the condition.
Display with backlighting
The liquid crystal display (LCD) shows programming information and messages. Backlighting helps keep the display visible in low light.
After a period of no key presses, backlighting turns off and the display blanks
to save battery power (except during an alarm or when an external power
source is in use). Press any key to turn the display back on.
NOTE: If you press
you wish to start or stop the pump; press ´or Î. Do not use
the display back on; this may deliver an inadvertent dose.
, the display will reappear with a message asking if
⁄
Í
to turn
Keypad
The keys on the keypad are described below. A key beeps when pressed if it is
operable in the current lock level.
⁄
Œ
Å
¤
„
4
starts and stops pump delivery.
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.) This key is also used
to access the Clinician Bolus while the pump is running.
is the “Help” key. It is used to display help for a screen or an alarm
message. (See Getting Help, this section.)
is used to enter, or save, a new value in the pump’s memory when
programming new doses or new pump settings. It is also used to
select an item from the Options Menu (Section 4) or Biomed
Toolbox Menu (Section 5).
is used to move from one programming screen to the next without
Section 1: General Description
changing the setting or value displayed. It is also used to return
from the Biomed Toolbox Menu to the Options Menu, or from the
Options Menu to the main screen. (See Sections 4 and 5.)
Description
General
Í
‹
´
Î
allows the patient to deliver a programmed amount of medication
upon request.
is used to access the Options Menu, which contains such features as
time, date, and the Event Log. (See Section 4, Options.)
allows you to answer “yes” to a question on the pump’s display,
“scroll up” or increase a value (for example, a dose amount), or
scroll through items on a menu.
allows you to answer “no” to a question on the pump’s display,
“scroll down” or decrease a value, scroll through items on a menu,
or cancel printing.
Power jack
You may plug a CADD™ External Power Source (EPS) system power pack or
an AC Adapter into the Power jack as an alternate source of power.
Data In/Out jack
The Data In/Out jack is used for attaching the following accessories:
• Interface Cable for printing reports
• Remote Dose Cord for remote operation of the dose key
• Modem Cable for communications
For more information on the Remote Dose Cord, printing or communications,
see the instructions for use provided with those products.
Air Detector Port Cover
This encloses the Air Detector port when the Air Detector is not attached.
Air Detector accessory (optional)
The Air Detector attaches to 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 6 for Air Detector specifications.)
The pump may be customized to require an Air Detector. (See Section 5,
Biomed Toolbox.) If an Air Detector is attached but not required, it may be
turned off.
WARNING: When the Air Detector is not installed, or is installed but turned
5
General
Description
Section 1: General Description
off, the pump will not detect air in the fluid path. It is recommended that you
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 part 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-Prizm® pump:
• Medication Cassette Reservoir (50 or 100 ml), used with a CADD
Extension Set
• CADD
™
Administration Set
WARNING: Follow the Instructions for Use provided with the Medication
Cassette Reservoir and CADD™ Extension Set, or the CADD™ Administration
Set, paying particular attention to all warnings and cautions associated with
their use. Incorrect preparation and/or use of these products could result in
serious patient injury or death.
™
™
Polemount Bracket recess
The optional Polemount Bracket slides into the recess on the back of the pump,
allowing you to attach the pump to an IV pole.
Battery compartment
The 9 volt battery fits into this compartment. The 9 volt battery serves as the
primary source of power, or as a backup when an EPS System power pack or
AC Adapter is in use.
Cassette latch
This attaches the cassette to the pump. The pump detects whether the cassette
is latched properly. Delivery will stop and an alarm will occur if the cassette
becomes unlatched.
Cassette lock
This allows you to secure the cassette to the pump using the key provided. The
cassette must be latched before it can be locked. The cassette must be locked
onto the pump or the pump will not run.
6
Section 1: General Description
Other Features Not Shown
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.”
Upstream Occlusion Sensor: (Model 6101 only) The pump contains an upstream occlusion sensor. This feature may be turned on or off (see Section 5,
Biomed Toolbox). 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). It is
recommended that you periodically inspect the fluid path for kinks, a closed
clamp, or other upstream obstructions. Upstream occlusions may result in
under- or non-delivery of medications to the patient. If undetected, these
occlusions could lead to death or serious injury to the patient.
Reservoir Volume Alarm: Reservoir Volume is a feature that 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 “Reservoir Volume Low” appears. This alarm recurs at every
subsequent decrease of 1 ml until the Reservoir Volume reaches 0 ml, at which
point the pump stops.
Description
General
7
General
Description
Section 1: General Description
The Main Screen
The main screen is the starting point for programming or viewing the pump’s
settings. The following information may be displayed:
Active delivery mode
When running:
Power source display
The current
*** PCA 6210X ***
Battery Low RUNNING
Res Vol 50.0 ml
Press NEXT to advance
Reservoir Volume
If no keys are pressed for a period of time (2 minutes when the pump is
stopped, 1 minute when running), the display reverts to the main screen. When
the 9 volt battery is low, “Battery Low” appears on the main screen. You can
configure the pump so the main screen always displays the type of power
source in use. (See Power Source Display, Section 5.)
running, stopped, or
dosing
A reminder that the
key lets you
„
advance (to program
or review settings)
Whether the pump is
8
Section 1: General Description
Description
General
Getting Help Using the
If you have a question about a screen, press the
tion of the screen will appear along with instructions for pump operations you
may be trying to perform. The following is an example of help for the Reser-
voir Volume screen:
This is the
calculated amount of
fluid left in the
reservoir. ?≥
• To page through all the help screens, press
original screen will reappear when no further help is available.
• To exit help, press any key (other than the
bring you back to the original screen.
• If a help screen tells you to press a certain key, first exit help, then
press that key.
Help screens are lock level dependent. If the pump’s current lock level prevents
access to a certain function, the function will not be described in the help
screens.
ÅÅ
Å
ÅÅ
Key
key for help. A descrip-
Å
The symbol in the lower right
corner means there are additional
help screens. Press the
again to see the next help screen.
repeatedly. The
Å
key). This will
Å
Å
key
9
Section 1: General Description
Lock Levels
General
Description
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.
AutoLock
AutoLock is one of the Options. This feature automatically changes the lock
level from LL0 to LL1 or LL2 when the pump is started (instead of requiring
you to manually change the lock level before giving the pump to the patient).
See Section 4 for more information on using AutoLock.
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 operating functions. Improper programming could result in death or
serious injury to the patient.
Customizing the Security Codes
If it becomes necessary to change the Lock Level Code and Biomed Toolbox
Code to ensure that a patient will be unable to access these features, you may
customize the Lock Level Code in the Biomed Toolbox. (See Section 5.) Customizing the Lock Level Code will not affect the Clinician Bolus Code.
10
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 of the pump.
Description
General
Pump Operations
and Programming LL0 LL1 LL2 Any Lock Level
Stop/Start the pump Yes Yes Yes Yes
View Help screens Yes Yes Yes Yes
Print Yes Yes Yes Yes
Reset Reservoir Volume Yes Yes Yes
Change the lock level Yes, w/code Yes, w/code Yes, w/code
Start a Demand Dose
Start a Clinician Bolus
Change Units Yes
Change Concentration Yes
Change Continuous Rate Yes Up to LL0 value
Change Demand Dose Yes Up to LL0 value
Clear Dose Counters Yes Yes
Clear Given amount Yes Yes
Add New Patient Marker Yes
Pump Options
No No No
No No No
Stopped Running
No
No
Yes
Yes, w/code
No No No
No No No
No No
No No
No No
No No
No No No
Prime Yes Yes
Extended History (view) Yes Yes Yes Yes
AutoLock Yes View only View only View only
Time Yes View only View only View only
Date Yes View only View only View only
Air Detector On/Off Yes View only View Only View Only
Event Log (view) Yes Yes Yes Yes
Biomed Toolbox Yes, w/code
No No No
No No
11
General
Description
Section 1: General Description
12
Section 2: Pump Setup and Programming
Section 2: Pump Setup and Programming
Installing the Battery
Use a new, 9 volt alkaline or lithium battery such as the DURACELL® Alkaline
MN 1604, the EVEREADY® ENERGIZER® Alkaline #522 or the ULTRALIFE® Lithium U9VL battery. The pump retains all programmed values while
the battery is removed. If the pump is running, you may connect an external
power source to keep the pump running for 3 minutes while you change the
battery.
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.
• There is no pump alarm to alert users that a battery has not been properly
installed or has become dislodged. An improperly installed or dislodged
battery could result in loss of power and non-delivery of drug and, depending on the type of drug being administered, could result in death or serious
injury to the patient.
Programming
Setup &
• If the pump is dropped or hit against a hard surface, the battery door may
become broken or damaged. DO NOT USE the pump if it has been damaged in this way because the battery will 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.
13
Section 2: Pump Setup and Programming
Ope
t
To install a battery
Setup &
Programming
1. Make sure the pump is stopped. Press the
button on the battery door and slide the
battery door forward. Remove the used
battery.
2. Match the + and – markings on
the new battery with the markings on the pump. Insert the
battery. The pump will beep if
the battery is inserted correctly.
3. Replace the battery door. The
pump will begin to power up.
NOTE: If you put the battery
in backwards, the display will
remain blank. Reinsert the
battery, making sure to match
the + and – markings.
atch
ery»
/Button»
CAUTION: Do not store the pump for prolonged periods with the battery
installed. Battery leakage could damage the pump.
NOTE:
• Battery life is dependent on the amount of medication delivered,
delivery rate, battery age, temperature, frequent screen display and
backlighting and frequent printing.
• The power of the battery will be quickly depleted at temperatures
below +10˚C (50˚F).
14
Section 2: Pump Setup and Programming
Watching Power Up
When you install a battery, 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, last error code (“lec”) if any, and serial
number (“sn”) will appear.
• The delivery mode contained in the pump and its software version
will appear.
• The display will turn completely on. Look for any stripes, which
would indicate a faulty display.
• If no Air Detector is attached, “No Air Detector attached” will
appear. The pump’s program screens will appear, followed by
screens showing the lock level setting, AutoLock setting (if in use),
Air Detector status (if an Air Detector is attached), time, and date.
You may need to confirm certain settings before power up will
continue. If messages appear, see the Alarms and Messages Table in
Section 6 of this manual for further explanation and instruction.
Programming
Setup &
NOTE:
• The pump will briefly pause. Then a message will appear showing
that the PCA delivery mode is currently active.
• When power up is complete, “Power Up Successful” will appear, six
beeps will sound, and the pump will be stopped.
• When the pump is powered up in Lock Level 0 with an Air Detector
attached, the pump will automatically turn on the Air Detector (the
Air Detector setting in Options will change to “Turned On.”)
• To move quickly through the power up screens, press
edly. To skip the automatic review entirely, press Î.
„
repeat-
15
Section 2: Pump Setup and Programming
Changing to Lock Level 0 (LL0)
Before programming the pump, make sure the lock level is LL0. LL0 allows the
clinician to access all programming and operating functions.
To change the lock level
Setup &
Programming
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 of the pump could
result in death or serious injury to the patient.
1. Make sure the pump is stopped.
Press
appear. (If the lock level is already
LL0, press
2. Press
3. Press
NOTE: If <Custom> appears on the
screen, the Lock Level Code has been
customized. Enter the custom Lock
Level Code in the next step.
4. Press ´ or
** Text Omitted **
. The current lock level will
Œ
to exit.)
„
or
´
Œ
until “LL0” appears.
Î
again. “000” will appear.
until
Î
Lock Level
| LL2
Lock Level
LL0
Lock Level Code
000
Lock Level Code
***
5. Press
Watch the display to verify that the
correct lock level is being entered. If
you do not see this message, the lock
level has not changed. Repeat the
above steps.
NOTE: To check the lock level, press
To return to the screen you were on, press
16
to set the new lock level.
Œ
Œ
Lock Level
LL0
<Changing...>
. The current lock level will appear.
.
„
Section 2: Pump Setup and Programming
Programming the Pump: General Instructions
The procedure for changing a programmed setting is similar for most programming screens. The following example of the Reservoir Volume screen illustrates
the typical features of a programming screen:
The | symbol means you
may use the
key to change the setting
´
or
Î
Reservoir Volume
| 10.0 ml
Screen
name
Programming
Setup &
“Range” shows the
minimum and
maximum settings
• 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
pears. (Press and hold these keys to change values with increasing
speed.) Then press
will appear automatically.
• To leave a setting unchanged, press
¤
<Range: 1 - 9999>
or
´
to save the new setting. The next screen
until the desired setting ap-
Î
to go to the next screen.
„
Setting
„
Messages you may see during programming
During programming, the following messages may appear:
“Press ENTER to save” will appear 10 seconds after you change a setting to
remind you to press
“Entering...” “Changing...” or “Resetting...” means the new setting is being
entered into the pump’s memory. The pump will display this message, then
automatically go to the next screen.
“Change — to...?” may appear for the following reasons:
¤
.
.
• you entered a new setting that must be confirmed,
• entry is required because you changed Units or Concentration, or
• you changed a setting and pressed a key other than
Press
20 seconds, or if you press
setting.PCA Delivery Method
to confirm the setting. If you do not press ´ within
´
, the screen will revert to the previous
Î
¤
.
17
Section 2: Pump Setup and Programming
PCA Delivery Method
The PCA delivery mode provides the following methods of delivery:
• Continuous Rate
• Demand Dose, activated by the patient
• Clinician Bolus, a dose activated by the clinician.
Setup &
Programming
You may program each of the methods individually or in combination with
each other. The Continuous Rate and Demand Dose are programmed as
described in this section. The Clinician Bolus feature is described in Section 3,
Operating the Pump. Ranges and programming increments are listed in the
Specifications in Section 6.
Clinician Bolus
(used here as a
loading dose)
Demand Doses
Continuous Rate
Dosage
18
Time
Section 2: Pump Setup and Programming
Programming Screens for PCA Delivery
The following figure illustrates the programming screens that are available in
the PCA delivery mode:
Reservoir Volume
Units
Concentration
(ml, mg or mcg)
Continuous Rate
Demand Dose
Reservoir Volume
| 100.0 ml
<Range: 1 - 9999>
Units
| Milligrams
<Range: mg or ml>
Concentration
| 1.0 mg/ml
<Range: 0.1 - 100>
Continuous Rate
| 5.00 mg/hr
<Range: 0 - 30.00>
Demand Dose
| 2.50 mg
<Range: 0 - 9.90>
Programming
Setup &
Demand Dose Lockout Time
Max Doses per Hour
Demand Dose Lockout
| 15 Min
<Range: 5 min-24 hr>
Max Doses Per Hour
| 2
<Range: 1 - 4>
19
Section 2: Pump Setup and Programming
Dose Counter
Given
Setup &
Programming
Air Detector (review)
Dose Counters
Given/Attempt: 0/ 0
since 06/08/05 10:35
Press ENTER to clear
Milligrams Given
0.00 mg
since 06/08/05 10:35
Press ENTER to clear
Air Detector
Required
<Review Only>
New Patient Marker (optional)
To insert New Patient
Marker and clear
Extended History
press ENTER
Reservoir Volume
Enter the volume of fluid contained in the fluid container. The Reservoir
Volume value decreases as the pump delivers fluid or you use the priming
feature. When you change the fluid container and reset the Reservoir Volume,
the value resets to the value entered 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).
Units
Enter the programming units. Possible settings are milliliters and milligrams.
Micrograms will also be one of the choices if the Micrograms settings in the
Biomed Toolbox is “On.” When you change the Units, the pump requires you
to enter or verify the Continuous Rate and Demand Dose. If the units are mg
or mcg, you must also enter the Concentration. Changing the Units clears the
amount Given and the Extended History.
20
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