CADD Prizm 6100, 6101 User Manual
OPERATOR’S
This online version differs from
the printed version.
Certain information that is not intended
for patients has been removed.
MANUAL
Model 6100 and 6101
Ambulatory
Infusion
Pump
This manual concerns only the CADD-Prizm® VIP (Variable Infusion Profile)
Model 6100 and Model 6101 ambulatory infusion pumps. The pump has the
following delivery modes:
PCA PCA 6210 (all revision letters)
Continuous CONTIN 6220 (all revision letters)
TPN TPN 6230 (all revision letters)
Intermittent INTERMT 6240 (all revision letters)
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® 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
infu-
sion system.
Smiths Medical MD, Inc.
1265 Grey Fox Road
St. Paul, Minnesota 55112 U.S.A.
1 800.426.2448
+1 651.633.2556
ii
Read this entire Operator’s Manual before operating the CADD-Prizm® VIP
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
UNDER-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 underdelivery 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
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 medication cassette reservoir
that does not have the flow stop feature (reorder number does not start
™
with 21-73xx): you must use a CADD
Extension Set with 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.
• 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.
v
• If Demand Doses are currently locked out, changing the Date and/or Time
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.
vi
• Do not use the pump near ECG equipment as the pump may interfere with
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.
vii
Table of Contents
WARNINGS iii
CAUTIONS vi
Section 1: General Description and Basic Operations 1
Introduction ............................................................................................... 1
Indications ................................................................................................. 1
Epidural/Subarachnoid ............................................................................... 1
Pump Diagram ........................................................................................... 3
Description of Keys, Display and Features ................................................. 4
The Main Screen ........................................................................................ 8
Getting Help Using the Å Key ................................................................. 9
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 a battery ...................................................................................... 13
Watching Power-Up .................................................................................... 15
Changing the Lock Level ............................................................................ 16
PCA Delivery Method
PCA Programming Screens ............................................................... 18
PCA Programming Example ............................................................ 23
PCA: Programming with Upper Limits, Adjusting Doses in
Lock Level 1 ............................................................................... 29
PCA: Starting a Clinician Bolus ........................................................ 30
PCA: Starting a Demand Dose ......................................................... 32
PCA: Stopping a Demand Dose or Clinician Bolus ........................... 33
viii
Continuous Delivery Mode
Continuous Programming Screens .................................................... 34
Continuous Programming Example ................................................. 37
CONTIN: Programming with Upper Limits, Adjusting Rate in
Lock Level 1 ............................................................................... 39
TPN Delivery Mode
TPN Programming Screens .............................................................. 40
TPN Programming Example ............................................................ 44
TPN: Starting Daily Infusion ............................................................ 47
Intermittent Delivery Mode
Intermittent Programming Screens ................................................... 48
Intermittent Programming Example ................................................. 52
INTERMT: Stopping the Pump During the Cycle ............................ 55
Section 3: Operating the Pump 57
Removing a Cassette .................................................................................. 57
Attaching a Cassette .................................................................................. 58
Priming the Tubing and Connecting to the Patient ..................................... 61
Setting the Lock Level for the Patient ......................................................... 63
Starting the Pump ...................................................................................... 65
Stopping the Pump...................................................................................... 65
Resetting the Reservoir Volume ................................................................. 66
Description
General
Programming
Setup &
Reservoir or
Admin Set
Options
Section 4: Options 67
Overview: Accessing Options ..................................................................... 67
Immediate Taper-Down: TPN .................................................................... 68
Prime ......................................................................................................... 69
Time Remaining: Intermittent .................................................................... 70
Extended History, Viewing: PCA ............................................................... 71
Change the Delivery Mode ........................................................................ 73
AutoLock ................................................................................................... 74
Time .......................................................................................................... 75
Date ........................................................................................................... 76
Air Detector On/Off .................................................................................. 77
Event Log, Viewing .................................................................................... 78
ix
Toolbox
Biomed
Troubleshooting
Reference &
Section 5: Biomed Toolbox 79
Overview: Accessing the Biomed Toolbox .................................................. 79
Micrograms On/Off (PCA Only) ............................................................... 80
Concentration Customization (PCA Only) ................................................. 80
Extended History On/Off (PCA Only) ....................................................... 82
Max Doses Per Hour On/Off (PCA Only) .................................................. 82
PM (Preventive Maintenance) Reminder .................................................... 83
Custom Lock Level Code ........................................................................... 83
Date Format .............................................................................................. 84
Power Source Status Display ...................................................................... 85
Upstream Sensor On/Off (Model 6101 only) ............................................. 85
Air Detector Requirement .......................................................................... 86
Section 6: Reference & Troubleshooting 87
Troubleshooting ......................................................................................... 87
Alarms and Messages, Alphabetical List .................................................... 89
Cleaning the Pump and Accessories ........................................................... 98
Exposure to Radiation or Magnetic Resonance Imaging (MRI) ................. 100
PCA Delivery Mode: Continuous Rate Scroll Ranges ................................ 101
PCA Delivery Mode: Demand Dose, Clinician Bolus Scroll Ranges,
Milliliters ............................................................................................. 101
PCA Delivery Mode: Demand Dose, Clinician Bolus Scroll Ranges,
Milligrams ........................................................................................... 102
PCA Delivery Mode: Demand Dose, Clinician Bolus Scroll Ranges,
Micrograms ......................................................................................... 103
Military Time Conversion Chart ................................................................ 104
Specifications (Nominal) ............................................................................ 105
Printed Reports ........................................................................................... 109
Index ......................................................................................................... 110
Limited Warranty ...................................................................................... 114
x
Section 1: General Description
Section 1: General Description and Basic Operations
Introduction
The CADD-Prizm® 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, the patient should be instructed in using the pump.
Indications
The CADD-Prizm® pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion.
PCA (Patient-Controlled Analgesia) delivery is used for therapies that require a
continuous rate of infusion, patient-controlled demand doses, or both, such as
patient-controlled analgesia.
Continuous delivery allows the infusion of drug at a constant, programmed
rate.
Description
General
TPN (Total Parenteral Nutrition) delivery allows the infusion of nutritional
solutions or other fluids, with optional tapering at the beginning and end of
infusion.
Intermittent delivery allows the infusion of a specific volume of drug at a
regular, programmed interval.
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.
1
General
Description
Section 1: General Description
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.
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 incor-
porate 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
Display
Indicator Lights
Amber
Green
Section 1: General Description
Description
General
Power jack
Data In/Out
jack
Air Detector
Port Cover
Air Detector
(optional)
Polemount
Bracket
Recess
Battery
compartment
2000-03-07 D. Zurn
«Prizm Rear 3/4 (dark BW)»
Front View
®
Rear View
Cassette
lock
Cassette
latch
Cassette
®
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 condi-
tion 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
the display back on; this may deliver an inadvertent dose.
Keypad
The keys on the keypad are described below. A key beeps when pressed if it is
operable in the current lock level.
, the display will reappear with a message asking if
⁄
or Î. Do not use
´
Í
to turn
⁄
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 in the PCA delivery mode.
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 pump settings. It is also used to select an item
from the Options Menu (Section 4) or Biomed Toolbox Menu
(Section 5).
„
Section 1: General Description
Description
General
is used to move from one programming screen to the next without
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.)
Í
‹
´
Î
is used only in the PCA delivery mode. It 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.
5
General
Description
Section 1: General Description
WARNING: 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.
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-Prizm® pump:
• Medication Cassette Reservoir (50 or 100 ml), used with a CADD
Extension Set
• CADD
• CADD-Prizm
™
Administration Set
™
High Volume Administration Set, for rates up to 350 ml/hr
(not for use in PCA mode)
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 (the part of the Medication Cassette Reservoir or
CADD
detects whether the cassette is latched properly. Delivery will stop and an alarm
will occur if the cassette becomes unlatched.
™
Administration Set that attaches to the pump) to the pump. The pump
Cassette lock
6
Section 1: General Description
This allows you to secure the cassette to the pump using the key provided. The
cassette must be latched before it can be locked. In the PCA delivery mode, the
cassette must be locked onto the pump or the pump will not run.
Downstream Occlusion Sensor (Not Shown)
The pump contains a downstream occlusion sensor. When a downstream
occlusion (between pump and patient) is detected, an alarm will sound, delivery will stop, and the display will show “High Pressure.”
Upstream Occlusion Sensor (Model 6101 only; Not Shown)
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 obstructions 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.
Description
General
Reservoir Volume Alarm (Not Shown)
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.
™
Medication Cassette Reservoir or CADD
pump calculates that 5 ml remain in the fluid container and a “Reservoir
Volume Low” message appears. This alarm recurs at every subsequent decrease
of 1 ml until the Reservoir Volume reaches 0 ml, at which point the pump
stops.
™
CADD-Prizm
High Volume Administration Set: When the pump calculates
that 25 ml remain in the fluid container, beeps sound and “Reservoir Volume
Low” appears. This alarm recurs at every subsequent decrease of 5 ml until the
Reservoir Volume reaches 0 ml, at which point the pump stops.
Administration Set: When the
7
Section 1: General Description
The Main Screen
General
Description
The main screen is the starting point for programming or viewing the pump’s
settings. If no keys are pressed, the display will eventually revert to the main
screen. The main screen within each delivery mode displays information about
the delivery status, as shown below.
PCA Delivery Mode
Power source status†
*** PCA 6210X ***
Battery Low RUNNING
Res Vol 50.0 ml
Press NEXT to advance
Delivery mode
“RUNNING” if the pump is running
“DOSING” if a Demand Dose is in progress
“STOPPED” if the pump is stopped
Continuous Delivery Mode
“RUNNING” if the pump is running
*** CONTIN 6220X ***
Battery Low RUNNING
Res Vol 50.0 ml
Press NEXT to advance
TPN Delivery Mode
*** TPN 6230X ***
Battery Low RUNNING ¤
Res Vol 50.0 ml
Press NEXT to advance
“STOPPED” if the pump is stopped
The current Reservoir Volume
Reminder that the NEXT key advances to
programming screens
“RUNNING ¤” if delivery is tapering up
“RUNNING ≥” if delivering at the plateau rate
“RUNNING ™” if delivery is tapering down
“RUNNING K” if delivering the KVO
“RUNNING I” if immediately tapering down
“STOPPED” if the pump is stopped
Intermittent Delivery Mode
*** INTERMT 6240X ***
Battery Low DOSING
Res Vol 50.0 ml
Press NEXT to advance
† The Power Source Status will only display when the 9 volt battery is low, unless the
pump has been customized to always show the type of power source in use. (See
Biomed Toolbox, Section 5.)
8
“DOSING” if a dose is in progress
“KVO” if the KVO rate is in progress
“KVO=0” if the pump is running but no KVO is
programmed
“STOPPED” if the pump is stopped
“DELAY” if the dose is delayed by Next Dose
Start Time (KVO is delivering)
Section 1: General Description
Getting Help Using the
For more information about a screen or message on the pump’s display, press
the
display. They may also explain why a screen or message appeared and what to
do next.
key to view help screens. Help screens describe what you see on the
Å
Å
Key
Description
General
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.
This 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:
• The Lock Level Code, 061 (the first two digits of the pump’s model
number), allows you to change the pump’s lock level.
• The Access Code, 071 (Lock Level Code + 10), allows you to
change the delivery mode and access Communications.
• The Clinician Bolus Code, 997, allows you to deliver a ClinicianActivated bolus.
• The Biomed Toolbox Code, 161 (Lock Level Code + 100), allows
access to the Biomed Toolbox settings.
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, Access 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 shows the features that can be accessed in each lock level. LL0
permits complete access to all programming and operating features. LL1
permits limited programming and access, and LL2 permits only minimal access.
Description
General
Pump Operations
and Programming LL0 LL1 LL2
Stop/Start the pump Yes Yes Yes
View Help screens Yes Yes Yes
Print Yes Yes Yes
Reset Reservoir Volume Yes Yes Yes
Reset Infusion Profile (TPN) Yes Yes Yes
Change the lock level Yes, w/code Yes, w/code Yes, w/code
Change the program Yes Within LL0 Limits†
Change Next Dose Start Yes
Time (INTERMT)
Clear Given amount Yes Yes
Clear Dose Counters (PCA) Yes Yes
Options
Immediate Taper-Down Yes, Yes, Yes, not
(TPN) programmable programmable programmable
Prime Yes Yes
Time Remaining, view (INTERMT) Yes Yes Yes
Extended History, view (PCA) Yes Yes Yes
Change Delivery Modes Yes, w/code
AutoLock Yes View only View only
Time Yes View only View only
Date Yes View only View only
Air Detector On/Off Yes View only View Only
Event Log, view Yes Yes Yes
Biomed Toolbox Yes, w/code
Stopped
No
No No
No
No
No
No No
No No
† In PCA and CONTIN delivery modes
11
General
Description
Section 1: General Description
12
Section 2: Pump Setup and Programming
Section 2: Pump Setup and Programming
Installing a 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.
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.
NOTE: If you put the battery in
backwards, the display will remain
blank. Reinsert the battery, making
sure to match the + and - markings.
/Button»
atch
ery»
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 modes contained in the pump and its software version
will appear. Make sure the desired delivery modes are displayed.
• 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 for further explanation and instructions.
Programming
Setup &
NOTE:
• When power up is complete, “Power Up Successful” will appear, six
beeps will sound, and the pump will be stopped.
• Make sure the pump is in the desired delivery mode. If not, change
the delivery mode before programming (Section 4, Options).
• 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 the Lock Level
Before programming the pump, make sure the lock level is LL0. LL0 allows the
clinician to access all programming and operating functions.
Setup &
Programming
To change the lock level
1. Make sure the pump is stopped.
Press
appear. (If the pump is already in the
desired lock level, press
. The current lock level will
Œ
„
to exit.)
Lock Level
| LL2
or
2. Press
3. Press
4. Press
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 or operating functions. Improper programming of the pump could result in
death or serious injury to the patient.
5. Press
´
level appears.
Œ
NOTE: If <Custom> appears on the
screen, the Lock Level Code has been
customized. Enter the custom Lock
Level Code in the next step.
´
Code “061” (or the custom code)
appears.
Œ
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.
until the desired lock
Î
again. “000” will appear.
or
until the Lock Level
Î
to set the new lock level.
Lock Level
LL0
Lock Level Code
000
Lock Level Code
061
Lock Level
LL0
<Changing...>
NOTE: To check the lock level, press
To return to the screen you were on, press
16
Œ
. The current lock level will appear.
.
„
Section 2: Pump Setup and Programming
PCA Delivery Method
The PCA delivery method provides the following methods of delivery:
• Continuous Rate
• Demand Dose, activated by the patient
• Clinician Bolus, a dose activated by the clinician.
You may program each of the methods individually or in combination with
each other. The following graph illustrates the combined delivery methods.
Ranges and programming increments are listed in the Specifications in Section 6.
Clinician Bolus
(used here as a
loading dose)
Demand Doses
Dosage
Continuous Rate
Programming
Setup &
Time
17
Section 2: Pump Setup and Programming
PCA Programming Screens
These are the programming screens for the PCA delivery method. Descriptions
of the screens follow.
Setup &
Programming
PCA Main Screen
Reservoir Volume
Units
*** PCA 6210X ***
STOPPED
Press NEXT to advance
Reservoir Volume
| 100.0 ml
<Range: 1 - 9999>
Units
| Milligrams
<Range: mg or ml>
Concentration
(ml, mg or mcg)
Continuous Rate
Demand Dose
Demand Dose Lockout
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>
Demand Dose Lockout
| 15 Min
<Range: 5 min-24 hr>
18
Max. Doses per Hour
Dose Counters
(Units) Given
Air Detector (review)
Section 2: Pump Setup and Programming
Max Doses Per Hour
| 2
<Range: 1 - 4>
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>
Programming
Setup &
To insert New Patient
New Patient Marker (optional)
Marker and clear
Extended History press
ENTER
Reservoir Volume
Enter the volume of fluid contained in a filled 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
19
Section 2: Pump Setup and Programming
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.
Concentration
If Units are mg or mcg, enter the concentration of drug in mg/ml or mcg/ml.
When you enter a new Concentration, the pump requires you to enter a new
Setup &
Continuous Rate and Demand Dose.
Programming
Continuous Rate
Enter the continuous rate of medication delivery (in mg/hr, ml/hr, or mcg/hr,
depending on the Units). The maximum rate is 30 ml/hr or the mg or mcg
equivalent. If the prescription does not call for a Continuous Rate, enter zero.
NOTE: If you intend to run the pump in Lock Level 1 so the Continuous Rate
can be varied, you should enter the maximum allowable rate while programming in Lock Level 0. After programming, you may then change to Lock Level
1 and decrease the rate to its starting value. See Programming with Upper
Limits, Adjusting Doses in LL1 at the end of this section
Demand Dose
Enter the amount of drug to be delivered when the patient presses the
(or the Remote Dose Cord button, if attached). If the prescription does not call
for a Demand Dose, enter zero.
NOTE: If you intend to run the pump in Lock Level 1 so the Demand Dose
can be varied, you should enter the maximum allowable dose while programming in Lock Level 0. After programming, you may then change to Lock Level
1 and decrease the dose to its starting value. See Programming with Upper
Limits, Adjusting Doses in LL1 at the end of this section.
Í
key
Demand Dose Lockout
If you programmed a Demand Dose, enter the minimum amount of time that
must elapse between the time one Demand Dose starts and the time the next
Demand Dose starts. This lockout period is unaffected by removal of the
battery or stopping of the pump.
20
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