Smiths Medical CADD-Prizm VIP 6100 User manual

CADD-Prizm®VIP
Ambulatory Infusion Pump
Model 6100 and 6101
Clinician Information
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This booklet provides guidelines for the use, care and maintenance of
the CADD-Prizm®VIP Ambulatory Infusion Pump. The Operator’s Manual
provided with this product contains warnings and cautions that the
user should be aware of for the safe use of the product. If you have any
questions regarding these systems, please contact Smiths Medical’s
Clinical Services Department at 1-800-258-5361.
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i
This guide pertains only to the CADD-Prizm®VIP (Variable Infusion
Profile) Model 6100 and 6101 ambulatory infusion pump and the following
delivery modes:
PCA Continuous TPN Intermittent
PCA 6210 CONTIN 6220 TPN 6230 INTERMT 6240
(all revision letters) (all revision letters) (all revision letters) (all revision letters)
WARNING:
>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.
>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.
>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.
>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
protect against unregulated gravity infusion that can result from
an improperly attached cassette.
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ii
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iii
Table of Contents
Section 1 General Description and Basic Operations 1
Description of the CADD-Prizm®VIP Pump .............................................. 1
Pump Diagram ........................................................................................... 2
Callout Descriptions ................................................................................... 3
Keypad ........................................................................................................ 3
Installing a Battery .................................................................................... 5
The Main Screen ........................................................................................ 6
Getting Help Using the ÅKey ............................................................... 7
Lock Level Table ........................................................................................ 8
Changing the Lock Level ........................................................................... 9
Changing Delivery Modes ........................................................................ 10
Starting and Stopping the Pump ............................................................. 11
Section 2 Pump Programming 12
PCA Delivery Mode
PCA Cycle Graph and Programming Screens .................................... 12
PCA Programming .............................................................................. 13
PCA: Programming with Upper Limits, Adjusting Doses in
Lock Level 1 ........................................................................................ 17
PCA: Starting a Clinician Bolus .......................................................... 18
PCA: Starting a Demand Dose ........................................................... 18
PCA: Stopping a Demand Dose or Clinician Bolus ............................ 19
Continuous Delivery Mode
Continuous Cycle Graph and Programming Screens ........................ 20
Continuous Programming ................................................................. 21
CONTIN: Programming with Upper Limits, Adjusting Rate in
Lock Level 1 ........................................................................................ 23
TPN Delivery Mode
TPN Cycle Graph and Programming Screens .................................... 24
TPN Programming ............................................................................. 25
TPN: Starting Daily Infusion ............................................................... 28
Intermittent Delivery Mode
Intermittent Cycle Graph and Programming Screens ....................... 29
Intermittent Programming ................................................................. 30
INTERMT: Stopping the Pump During the Cycle ................................ 33
Time Remaining .................................................................................. 34
Changing the Next Dose Start Time.................................................... 34
Resuming the Dose ............................................................................. 34
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iv
Section 3 Medication Reservoir or Administration Set 35
Removing a Used Reservoir or Administration Set ................................. 35
Attaching a New Reservoir or Administration Set .................................. 36
Priming the Tubing and Connecting to the Patient ................................. 39
Resetting the Reservoir Volume .............................................................. 41
Section 4 Options 42
Overview: Accessing Options ................................................................... 42
Immediate Taper-Down: TPN .................................................................. 43
Prime ........................................................................................................ 43
Time Remaining: Intermittent ................................................................. 43
Extended History, Viewing: PCA .............................................................. 44
Changing Delivery Modes ........................................................................ 45
AutoLock .................................................................................................. 45
Time ......................................................................................................... 46
Date .......................................................................................................... 46
Air Detector On/Off .................................................................................. 46
Event Log, Viewing ................................................................................... 46
Communications ...................................................................................... 47
Biomed Toolbox ........................................................................................ 47
Section 5 Accessories 48
Printing Reports ....................................................................................... 48
Power Pack or AC Adapter ...................................................................... 48
Remote Dose Cord ................................................................................... 49
CADD®Pump Pouches .............................................................................. 50
Security Shell ........................................................................................... 50
Using the Lockable Polemount Bracket ................................................. 52
Section 6 Troubleshooting and Reference 54
Alarms and Messages, Alphabetical List ................................................ 54
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1
General Description and Basic Operations Section 1
Basic Operations
Description of the CADD-Prizm®VIP Pump
The CADD-Prizm®VIP ambulatory drug delivery pump provides measured
drug therapy to patients in hospital or outpatient settings.
The PCA (Patient-Controlled Analgesia) delivery mode is used for thera-
pies that require a continuous rate of infusion, patient-controlled demand
doses, or both, such as patient-controlled analgesia.
The Continuous delivery mode allows the infusion of drug at a constant,
programmed rate.
The TPN (Total Parenteral Nutrition) delivery mode allows the infusion of
nutritional solutions or other fluids, with optional tapering at the begin-
ning and end of infusion.
The Intermittent delivery mode 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. 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 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.
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2
Section 1 General Description and Basic Operations
?
START
STOP
Y
N
LOCK
DOSE
NEXT
ENTER OPTIONS
NO AIR
DETECTOR
INSTALLED
Power Data In/Out
Cassette
Display
Polemount
Bracket
Recess
Power Jack
Keypad
Cassette Lock
Cassette Latch
Battery
Compartment
Data In/Out
Jack
Air Detector
Port Cover
Air Detector (op-
tional)
Indicator Lights
Amber Green
Rear View
Front View
Pump Diagram
Upstream Occlusion Sensor
(Model 6101 only)
®
®
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3
General Description and Basic Operations Section 1
Basic Operations
Callout Descriptions
Indicator lights
Green: flashes when the pump is running
Amber: flashes when the pump is stopped or alerting to an alarm; lit
continuously when the pump is inoperable
Display
Shows programming information and messages
Power jack
Connects to a CADD®External Power Source (EPS) System Power
Pack or an AC adapter for wall outlet
Data in/out jack
Used for attaching accessories:
>Interface Cable to connect to a PC
>Remote Dose Cord for remote operation of the dose key
Cassette
The portion of the reservoir or administration set that attaches to the
bottom of the pump
Polemount bracket recess
Bracket slides into the recess on the back of the pump, for attaching
the pump to an IV pole
Keypad
⁄starts and stops pump delivery
Œdisplays or changes the lock level; allows access to the
clinician bolus in the PCA delivery mode
Ådisplays more information for a screen or an alarm message
€saves a new value when programming; records a selection
from a menu; clears recordkeeping screens
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4
Section 1 General Description and Basic Operations
Keypad (continued)
„scrolls through programming screens without changing the
settings; returns you from the Biomed Toolbox menu to the
Options menu, or from the Options Menu to the main screen
Íin the PCA delivery mode, delivers a programmed amount
of medication
‹displays the Options menu
´answers “yes,” increases values on programming screens,
or scrolls through items on a menu
Îanswers “no,” decreases values on programming screens,
scrolls through items on a menu, or cancels printing
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5
General Description and Basic Operations Section 1
Basic Operations
Door w/Button»
«Prizm Match
Battery»
Installing a Battery
Use a fresh, 9 volt alkaline or lithium battery such as the DURACELL®
Alkaline MN 1604 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.
CAUTION:
>Do not store the pump for prolonged periods with the battery installed. Battery
leakage could damage the pump.
WARNING:
>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.
>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.
>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.
>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.
To install a battery
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.
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6
Section 1 General Description and Basic Operations
The Main Screen
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
Continuous Delivery Mode
TPN Delivery Mode
Intermittent Delivery Mode
* 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.
*** PCA 6210X ***
Battery Low RUNNING
Res Vol 50.0 ml
Press NEXT to advance
Power source status*
Delivery mode
RUNNING if the pump is running
DOSING if a demand dose is in
progress
STOPPED if the pump is stopped
RUNNING if the pump is running
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 Kif delivering the KVO
RUNNING Iif immediately
tapering down
STOPPED if the pump is stopped
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)
*** CONT 6220X ***
Battery Low RUNNING
Res Vol 50.0 ml
Press NEXT to advance
*** INT 6240X ***
Battery Low DOSING
Res Vol 50.0 ml
Press NEXT to advance
*** TPN 6230X ***
Battery Low RUNNING €
Res Vol 50.0 ml
Press NEXT to advance
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7
General Description and Basic Operations Section 1
Basic Operations
Getting Help Using the ÅKey
For more information about a screen or message on the pump’s display,
press the Åkey to view help screens.
>To page through all the help screens, press Årepeatedly. The
original screen will reappear when no further help is available.
>To exit help, press any key (other than the Åkey). This will 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 is the
calculated amount of
fluid left in the
reservoir. ?≥
This symbol in the lower right
corner means there are additional
help screens. Press the Åkey
again to see the next help screen.
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Section 1 General Description and Basic Operations
Lock Level Table
Lock levels are used to limit patient access to certain programming and
operating functions.
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.
* In PCA and CONTIN delivery modes
Pump Operations
Stopped
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* No
Change Next Dose Start Yes No No
Time (INTERMT)
Clear Given amount Yes Yes No
Clear Dose Counters (PCA) Yes Yes No
Immediate Taper-Down Yes, Yes, Yes, not
(TPN) programmable programmable programmable
Prime Yes Yes No
Time Remaining, view (INTERMT) Yes Yes Yes
Extended History, view (PCA) Yes Yes Yes
Change Delivery Modes Yes, w/code No No
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 No No
Options
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General Description and Basic Operations Section 1
Basic Operations
Changing the Lock Level
Before programming the pump, make sure the lock level is LL0 so you
can access all programming screens.
After programming, the lock level must be changed to LL1 or LL2 to
prevent the patient from having complete access to all programming and
operating functions.
If AutoLock is not in use and the lock level is LL0 when you attach a
cassette, the message “AutoLock not in use / Change Lock Level from
LL0?” will appear; this allows you to set the lock level to LL1 or LL2 with
the steps below. For detailed information on lock levels, see page 8.
NOTE: You may change the lock level at any time by stopping the pump and
pressing Œ. Then begin with step 2 below.
To change the lock level
1. With this message displayed, press
´. (If you do not wish to change the
lock level at this time, press Î.)
2. The current lock level will appear.
3. Press ´or Îuntil the desired lock
level (LL1 or LL2) appears.
4. Press
Œagain. “000” will appear.
5. Press ´or Îuntil the Lock Level
Code appears.
6. Press
Œto set the new lock level.
Watch the display to verify that the
correct lock level is being entered.
Lock Level
LL1
<Changing...>
AutoLock not in use.
Change Lock Level
from LL0?
Press Y or N
Lock Level
LL0
Lock Level
LL1
Lock Level Code
000
Lock Level Code
XXX
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Section 1 General Description and Basic Operations
Changing Delivery Modes
The CADD-Prizm®VIP pump contains four delivery modes: PCA, CONTIN,
TPN, INTERMT. To change the mode, you must know the access code
(Lock Level code plus 10). When you change the mode, the program will
revert to the default settings, and the event log will clear. Therefore, you
may wish to print the event log before changing the mode. Other Options
settings will not be affected.
To change the delivery mode
The pump must be stopped and in LL0.
1. Press
‹.
Press ´or Îuntil “Delivery
Modes” appears, then press €.
2. Press
´or Îuntil the Access
Code appears (See the Operator’s
Manual; Lock Code +10).
Then press €.
NOTE: If the Lock Level code has been
customized, use the new Lock Level
code+10.
3. Press ´or Îto select the desired
delivery mode. Then press €.
4. Press
´to confirm the change.
The pump will go through the power
up sequence in the new delivery
mode. If messages appear, refer to
the table on page 54 or press Å
for help.
5. After the power up sequence, this
message will appear followed by the
first programming screen in the new
delivery mode.
Options
| Delivery Modes
Press § or fl or ENTER
Access Code
XXX
Pump is ready to
program
NEXT to continue
Change Delivery Mode
to CONTIN 6220X?
Press Y or N
Select
| CONTIN 6220X
Press § or fl or ENTER
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11
General Description and Basic Operations Section 1
Basic Operations
Starting the Pump
When you start the pump, programmed values will be automatically
reviewed. Then fluid delivery will begin as programmed and the
green indicator light will blink. If the pump will not start, a message
will appear on the display. Refer to the Alarms and Messages Table
on page 54.
To start the pump
1. Press
⁄“Start the Pump?”
will appear.
2. Press
´. “Starting Pump”
will appear.
The pump will review the program,
lock level, AutoLock setting,
Air Detector status, time, and date.
If AutoLock is in use, “AutoLock is
changing lock level to (LL1 or LL2)”
will appear.
Stopping the Pump
When the pump is stopped, no delivery occurs. “STOPPED” appears on
the main screen and the amber indicator light blinks.
To stop the pump
1. Press
⁄.
If a demand dose or clinician bolus is
in progress, “Stop Demand Dose?” or
“Stop Clinician Bolus?” will
appear. Press ´to stop the dose.
2. When “Stop the Pump?” appears,
press ´.
Stop Demand Dose?
Press Y or N
Stop the Pump?
Press Y or N
Start the Pump?
Press Y or N
AutoLock is
changing Lock Level
to LL2
Starting pump...
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12
Section 2 Pump Programming - PCA Delivery Mode
Clinician Bolus
(used here as
a loading dose)
Demand Doses
Continuous Rate
Time
Dosage
New Patient Marker
Reservoir Volume
Units
Concentration
Continuous Rate
Demand Dose
Demand Dose Lockout
Max Doses Per Hour
Dose Counters
(Units) Given
*** PCA 6210X ***
STOPPED
Press NEXT to advance
If Units are
mg or mcg
If a Demand Dose
is programmed
Air Detector (Review)
If Extended
History is on
If Air Detector
is installed
PCA Cycle Graph and Programming Screens
The PCA delivery mode provides the following methods
of delivery:
> Continuous Rate
> Demand Dose, activated by the patient
> Clinician Bolus, a loading dose activated by the clinician.
You may program a continuous rate, a demand dose, or both.
The clinician bolus is described later in this section.
The following figure shows the programming screens in the
PCA delivery mode:
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13
Pump Programming - PCA Delivery Mode Section 2
Pump
Programming
PCA Programming
Before programming:
>Stop the pump and change the Lock Level to LL0 as described
on page 9.
>Select the PCA delivery mode as described in Changing Delivery
Modes on page 10. If the pump is already in the PCA delivery mode,
you may select it again to clear all programming screens to their
default settings.
1. Begin at the main screen
>Make sure the pump is in LL0.
>Make sure PCA and STOPPED appear
on the main screen.
>Press
„to begin.
2. Enter the reservoir volume
>Press ´or Îto select the volume
of fluid in a filled reservoir. (If you do
not wish to use the reservoir volume
feature, scroll down to “Not In Use”
located before 1.)
>Press
€.
3. Enter the units
To accept the current programming units,
press „.
Or, to change the units:
>Press
´or Îto select the desired
programming units.
>Press
€.
>Press
´to confirm the change.
NOTE: If the prescription calls for milliliters,
enter milliliters and skip to step 5.
Units
| Milligrams
<Range: mg or ml>
Reservoir Volume
| 100.0 ml
<Range: 1 - 9999>
*** PCA 6210X ***
STOPPED
Press NEXT to advance
Change Units to
Milligrams?
Press Y or N
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14
Section 2 Pump Programming - PCA Delivery Mode
4. Enter the concentration of the drug
This screen will not appear if the units are milliliters; go to step 5.
>Press
´or Îto select the
desired concentration. (If you
cannot select the desired
concentration, it may have been
turned off in the biomed toolbox.)
>Press
€.
>Press
´to confirm the change.
NOTE: If you change the concentration,
you must enter the continuous rate and
demand dose.
5. Enter the hourly continuous rate
>Press ´or Îto select the
desired continuous rate of drug
delivery.
>Press
€.
NOTE: If “Change Rate to...?” appears, you
must confirm the rate because the units
or concentration was changed, or the
rate is greater than or equal to 100 mg/hr
or mcg/hr. Press ´to confirm, or press
Îand re-enter the rate.
6. Enter the demand dose amount
>Press ´or Îto select the
desired amount delivered when
patient presses the dose key.
>Press
€.
NOTE: If “Change demand dose to...?”
appears, you must confirm the dose
because the units or concentration was
changed, or the dose is greater than or
equal to 100 mg or mcg. Press ´to
confirm, or press Îand re-enter the dose.
Concentration
| 1.0 mg/ml
<Range: 0.1 - 100>
Change Concentration
to 1.0 mg/ml?
Press Y or N
Continuous Rate
| 5.00 mg/hr
<Range: 0 - 30.00>
Demand Dose
| 2.50 mg
<Range: 0 - 9.90>
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