Smiths Medical CADD-Solis Operator's Manual

X

This online version differs from the printed

version.

Certain information that is not intended for

patients has been removed.

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The CADD®-Solis ambulatory infusion system
is designed to promote patient care and safety
for a variety of adult and pediatric patients and
clinical care areas, including, but not limited to,
post-operative, trauma, critical care, oncology, and
labor and delivery. This manual concerns only the
CADD
pump can be programmed with a pump protocol
configuration, consisting of a therapy, qualifier,
and drug. The pump can deliver medication at a
constant rate and/or with a bolus dose.

This manual is intended for clinician use only, do
not permit patients to have access to it. The pump
has three security levels designed to limit overall
patient access and clinician access to certain pump
features. Only disclose the pump’s security codes to
those who are authorized. Patient and unauthorized
clinician access to the pump key should also be
restricted.

The issue date of this Operator’s Manual is included
on the back cover. In the event one year has elapsed
between the issue date and product use, the clinician
should contact Smiths Medical to see if an updated
revision of this manual is available.

-Solis ambulatory infusion pump. This

®

Technical Assistance

If you have comments or questions concerning the
operation of the CADD®-Solis ambulatory infusion
pump, please call the number given below. When
calling, please specify the pump’s software version
number. This information is located in the Device
Information Report (See Reports on page 27).

Our staff at Smiths Medical is available to help twenty­four hours a day with the programming and operation
of the CADD®-Solis ambulatory infusion pump.

U.S. Distribution:

Smiths Medical MD, Inc.

1265 Grey Fox Road
St. Paul, MN 55112
1 800.426.2448
+1 651.633.2556
www.smiths-medical.com

European Distribution:

Smiths Medical International Ltd.

WD24 4LG, UK
[phone]

Read this entire Operator’s Manual before operating
the CADD

Failure to properly follow warnings, cautions, and
instructions could result in death or serious injury to
the patient.

-Solis ambulatory infusion pump.

®

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.

• To avoid explosion hazard, do not use the

pump in the presence of flammable anesthetics
or explosive gases.

• 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 in order
to assure minimum medication delivery
interruption. Pump failure will suspend
medication delivery, and unintended
pump operations could lead to a variety of
consequences for the patient.

• If the pump is used to deliver life-sustaining

medication, an additional pump must be
available, and close supervision and provision
for immediate corrective action should be
provided to assure minimum medication
delivery interruption in the event of a pump
failure. Pump failure will suspend medication
delivery.

• The pump is not to be used for delivery of

blood or cellular blood products, as blood
and blood products will be damaged by the
pumping mechanism.

• 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 Smiths Medical Customer Service to
return a pump for service.

1

• Use of a syringe with the CADD

administration set may result in UNDER
DELIVERY of medication. Syringe function
can be adversely affected by variations in
plunger dimension and 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

Clinicians must regularly compare the volume

remaining in the syringe to the pump’s
displayed values such as reservoir volume
and given in order to determine whether the
under-delivery of medication is occurring and
if necessary, take appropriate action.

-Solis pump.

®

®

• There are potential health hazards associated

with improper disposal of batteries,
electronics, and contaminated (used)
reservoirs and extension sets. Dispose of used
batteries, reservoirs, extension sets, and other
used accessories, or a pump that has reached
the end of its useful life, in an environmentally
safe manner, and according to any regulations
that may apply.

• Do not administer drugs to the epidural space

or subarachnoid space unless the drug is
indicated for administration to 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 CADD™ medication cassette reservoir or

CADD® extension or 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.

• Do not use rechargeable NiCd 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, non-delivery of
drug will occur.

• There is no pump alarm to alert users that a

battery has not been properly installed. An
improperly installed battery could result in
loss of power and nondelivery of drug.

• Always check the battery compartment for

fluid or debris before inserting the batteries
and do not allow any fluid or debris to fall
into the battery compartment. Fluid or debris
in the battery compartment may damage the
battery contacts and could result in loss of
power and nondelivery 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 batteries will not be properly
secured; this may result in loss of power and
nondelivery of drug.

• Follow the instructions for use provided

with the CADD™ medication cassette
reservoir, CADD® extension set, or CADD®
administration set, paying particular attention
to all warnings and cautions associated with
their use.

• 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,
which could result in death or injury to the
patient.

If you are using a CADD® administration set

or CADD™ medication cassette reservoir that
does not have the flow stop feature: 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.

2

• Per general rules of safe practice, always clamp

tubing before removing the cassette from the
pump. Removing the cassette without closing
the clamp could potentially cause unregulated
gravity infusion.

• The use of power supplies and a remote

dose cord other than those listed in the
electromagnetic emissions declaration may
result in increased emissions or decreased
immunity of the pump

• 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 security codes.

• Never leave the pump unattended while on

the clinician bolus edit screen. You must
press “Confirm” or “Deliver” to deliver the
programmed value or cancel to leave the
screen. Failure to do so could result in serious
patient injury or death.

• Do not prime the fluid path with the tubing

connected to a patient as this could result in
overdelivery of medication or air embolism.

• Ensure that the entire fluid path is free of all

air bubbles before connecting to the patient to
prevent air embolism.

• The manual mode does not contain

programming limits. Be sure to carefully
review each parameter to ensure it accurately
matches the prescription.

• The pump should not be used adjacent to

or stacked with other equipment. If adjacent
or stacked use is necessary, the user should
verify normal operation of the pump in the
configuration in which it is to be used.

CAUTIONS

• To avoid damaging the pump’s electronics, do

not operate the pump at temperatures below
2°C (36°F) or above 40°C (104°F)

• To avoid damaging the pump’s electronics,

do not store the pump at temperatures below
–20ºC (–4°F) or above 60°C (140°F). Do not
store the pump with a medication cassette
reservoir or CADD® administration set
attached.

• To avoid damaging the pump’s electronics, do

not expose the pump to humidity levels below
20% or above 90% relative humidity.

• CADD

damaged seal will, therefore, be considered
conclusive evidence that the pump has been
misused and/or altered, which voids any
and all warranties. All service and repair of
CADD® pumps must be performed by Smiths
Medical or its authorized agents.

pumps are sealed units. A broken or

®

• Ensure that the ± 6% system delivery accuracy

specification is taken into account when
programming the pump and/or filling the
reservoir. Failure to do so may result in
medication in the reservoir becoming depleted
sooner than expected.

• 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), and placing the infusion
reservoir and/or pump above or below the
level of the patient.

• Inspect the AA batteries for damage or wear

to the metal or plastic insulation prior to use,
or after the pump has been dropped or hit.
Replace the batteries if any damage is noted.

• Do not store the pump for prolonged periods

with the batteries installed. Battery leakage
could damage the pump.

• If the power up results in an error message

indicating that the protocol library was lost, do
not proceed with using the pump. Follow your
facility’s procedures for downloading protocol
libraries.

3

• Only use accessories that are specified for use

with the CADD®-Solis ambulatory infusion
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.

• If the power up results in an error message

indicating that the protocol library was lost, do
not proceed with using the pump. Follow your
facility’s procedures for downloading protocol
libraries.

• Do not immerse the pump in cleaning fluid

or water. Do not allow solution to soak in to
the pump, accumulate on the keypad, or enter
the battery compartment, USB port, remote
dose cord jack, or power jack areas. Moisture
buildup inside the pump may damage the
pump.

• Use of this pump on patients monitored by

electronic equipment may cause artifactual
interference. As with all electronic equipment,
electrical artifacts which affect the
performance of other equipment, such as ECG
monitors, can occur. The user should check
the correct function of the equipment prior to
use.

• Do not use the pump in hyperbaric chambers

as they will affect how the pump works and
may also cause damage to the pump.

• Do not clean the pump with acetone, other

plastic solvents, or abrasive cleaners, as
damage to the pump may occur.

• The pump SHOULD NOT BE DIRECTLY

IRRADIATED by therapeutic levels of ionizing
radiation because of the risk of permanent
damage to the pump’s electronic circuitry.
The best procedure to follow is to remove the
pump from the patient during therapeutic
radiation sessions or diagnostic levels of
radiographic and fluoroscopic radiation. If
the pump must remain in the vicinity during
a diagnostic or 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.

• Magnetic fields produced by magnetic

resonance imaging (MRI) equipment 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.

4

Table of Contents

Technical Assistance ............................................................ 1

WARNINGS .............................................................................. 1

CAUTIONS ...............................................................................3

General Description ............................................7

Introduction ...........................................................................7

Indications ............................................................................... 7

Epidural/Subarachnoid Administration ........................7

Analgesics ...................................................................... 7

Anesthetics ................................................................... 7

Symbols .................................................................................... 8

Features of the pump system ...........................................9

Pump Diagram.....................................................................11

Description of the Keys, Components, Ports,

and Connectors ...................................................................11

Indicator Lights ..........................................................11

Display with backlighting ...................................... 11

Keypad ......................................................................... 12

Power Switch .............................................................. 12

Power Jack ...................................................................12

USB Port ....................................................................... 12

Remote Dose Cord Jack ..........................................12

Battery Compartment .............................................12

Cassette Latch ............................................................ 12

Cassette/Keypad Lock ............................................. 12

Delivery Methods ............................................................... 13

Pump Setup ....................................................... 14

Installing the Batteries ...................................................... 14

Replacing the battery door ................................... 15

Power Up ............................................................................... 15

Description of pump accessories .................................. 15

CADD

Desktop AC Adapter ................................................15

Rechargeable Battery Pack .................................... 15

Cassette ........................................................................ 16

Remote Dose Cord ................................................... 16

Polemount Bracket Adapter..................................16

Polemount Bracket ...................................................16

Pump Key ..................................................................... 16

Programming the Pump: General Instructions ........ 17

The Pump Screen ...................................................... 17

Color Display ..............................................................17

Before Programming ............................................... 18

Attach a Cassette ................................................................ 18

Remove a Cassette ............................................................. 19

Start the Pump.....................................................................19

Stop the Pump .....................................................................20

-Solis Medication Safety Software ....... 15

®

Programming and Operation ..........................21

Security Settings ................................................................. 21

Security Level Table .................................................21

Autolock .......................................................................22

Tasks ........................................................................................22

Give Clinician Bolus ..................................................22

Start New Patient ......................................................23

Start New Protocol, Same Patient ....................... 24

Prime Tubing ..............................................................24

Set Time and Date ....................................................25

Adjust Backlight Intensity ...................................... 26

Adjust Alarm Volume ...............................................26

View Reports ..............................................................26

Adjust Admin Settings ............................................27

Reports ................................................................................... 27

Given and PCA Dose Counters .............................27

PCA Dose Graph ........................................................28

Delivery History and Pie Chart .............................28

Delivery Log ................................................................ 28

Event Log .....................................................................28

Protocol Library Summary .....................................29

Device Information ..................................................29

Patient Specific Parameters (Programming Screens) .29

Continuous Rate ........................................................ 30

PCA Dose .....................................................................30

PCA Lockout ...............................................................30

Hourly Limit ................................................................ 31

Max Doses/Hr ............................................................. 31

Reservoir Volume ...................................................... 32

Manual Mode Programming .......................................... 32

References and Troubleshooting ....................35

Understanding the Alarms and Messages .................35

Alarms and Messages, Alphabetical List .....................36

Cleaning the Pump and Accessories ............................ 43

Exposure to Radiation

or Magnetic Resonance Imaging (MRI) .......................43

Continuous Rate Scroll Ranges ......................................44

PCA Dose, Clinician Bolus Scroll Ranges: Milliliters ......44

PCA Dose, Clinician Bolus Scroll Ranges: Milligrams .....44

PCA Dose, Clinician Bolus Scroll Ranges: Micrograms ..44

Technical Description ........................................................ 45

Specifications (Nominal) ..................................................46

General Pump Specifications ...............................46

Delivery Specifications ...........................................48

Administrator Settings Specifications ...............48

Electromagnetic Emissions

and Immunity Declarations ................................... 49

5

Collect Separately ................................................... 51

Z

Programming Screens/Menus Maps .................. 51

Default Factory Settings ...................................................52

Accuracy Test Results ........................................................53

Start-up curve over the stabilization period

Flow rate: Intermediate (10 mL/hr) ..................... 53

Trumpet Curve over T(2) Period:

Intermediate rate (10 mL/hr) .................................53

Index ..................................................................55

Limited Warranty .............................................59

6

General Description

General Description

Introduction

The CADD®-Solis ambulatory infusion pump
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®-Solis ambulatory infusion pump
is indicated for intravenous, intra-arterial,
subcutaneous, intraperitoneal, in close proximity
to nerves, into an intraoperative site (soft tissue,
body cavity/surgical wound site), 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).

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.

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
serious patient injury or death.

• 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. e
inadvertentuseofinjectionsitesforinfusion
of such drugs may cause serious patient injury
or death.

• IfaCADD™medicationcassettereservoiror

CADD® extension or administration set is used
for epidural space or subarachnoid space drug

delivery,itisstronglyrecommendedthatit

be clearly dierentiated from those used for
other routes of infusion, for example, by color
coding, or other means of identication. Drugs
not intended for epidural or subarachnoid
space infusion could result in serious patient
injury or death.

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.

Anesthetics

Administration of anesthetics to the epidural
space is limited to use with indwelling catheters
specifically indicated for short-term drug delivery.

7

General Description

Symbols

Direct Current (Power Jack)

1
f

K
J

E

D

<
>

6

Consult Instructions for Use

Caution

Class II Equipment

Type CF Equipment

Splashproof—water splashed against pump
housing will have no harmful effects (see
Cleaning the Pump and Accessories on p. 44
for additional important information)

Date of Manufacture

Catalog Number

Serial Number

CAUTION:Federal (USA) law restricts
this device to sale by or on the order of a
physician.

Collect Separately

Z

P
_
i

@

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Authorized Representative in the European
Community

Symbols on the pump’s display

Indicates reservoir volume

Rechargeable battery pack charge level

Rechargeable battery pack charge level, with
AC adapter

AA battery charge level

AA battery charge level, with AC adapter

No battery installed, AC power only

Incompatible battery

Incompatible battery, with AC adapter

Pump status is running

Pump status is paused or in KVO

Pump status is stopped

Arrows used in the soft key bar indicating there
are more items to see by pressing U or D

Arrows used in the soft key bar indicating the
top of the menu, press D to move through the
menu

Arrows used in the soft key bar indicating
the bottom of the menu, press U to move
through the menu

Home screen

Indicates keypad is locked

Australian Representative

Power on/off button

USB port

Remote dose cord jack

Cassette lock/unlock

AA battery location, positive terminal
faces up

AA battery location, negative terminal
faces up

AA battery location, positive terminal
faces up

AA battery location, negative terminal
faces up

8

Indicates keypad is unlocked

Appears next to parameter if it has been
reviewed and accepted

Appears on edit screens where a value is scrolled;
indicates where the value is being scrolled

Appears on edit screens where there is a
menu of options; indicates which setting is
being selected

Indicates the requested action could not be
performed (e.g., wrong security code entered)

Appears on PCA dose report to indicate
more data is available

Review screen

Appears when the pump is saving an edited
parameter

General Description

Features of the pump system

The CADD®-Solis ambulatory infusion system
delivers break-through advancements in patient­centered pain management infusion solutions.
The CADD®-Solis ambulatory infusion pump
and CADD®-Solis Medication Safety Software are
designed to help promote optimal patient safety,
patient care, and a scalable connectivity platform
designed to grow with evolving clinical and
technology needs.

Patient Safety—Built-in medication delivery
safety features and advancements in programming
simplicity enable a patient-focused, treatment­orientated infusion system designed to help address
medication safety goals and reduce the risk of
programming errors:

• State-of-the-art technology designed to meet

advanced dose-error reduction guidelines:

– Initial programming set-up.
– Dose limits.
– Indication of overridden soft limits.
– Configure protocol library to current

practices.
– Software that is simple to operate.
– Display protocol and drug name at all

times.
– Tracks limit overrides and programming

changes.

• Customizable therapy-based protocol libraries

deploy user’s best practices in all care areas:

– Facility-defined protocol library includes

the therapy, qualifier, drug, unit/

concentration, dose limits, and drug

delivery parameters.
– Personalize therapy within user-defined soft

and hard limits.
– Simulates standard flow sheet used in many

healthcare facilities.

• Secure access and simple menu structure with

soft-key interface and familiar CADD® pump
scroll keys:

– Soft key interface helps make programming

and navigating intuitive and easy.
– Scroll keypad prevents entering values

outside of defined program limits.
– Designate authorized users with levels of

security access.

Patient Care—A versatile multi-therapy infusion
system designed to support pain management
medication delivery needs. The compact,
lightweight design promotes patient mobility, which
is associated with improved clinical outcomes,
reduced length-of-stay, and reduced treatment costs:

• A highly versatile, multi-therapy pain

management infusion system:

– IV PCA, epidurals, nerve blocks, surgical

site infusion therapies.

– Therapies that require a continuous rate of

infusion, patient-controlled PCA doses, or
both (such as patient-controlled analgesia).

– Post-op, labor and delivery, trauma, and

pediatrics.

• Medication delivery focused on the point of

care:

– Strikingly clear screen displays therapy

protocol, drug, medication delivery settings,
and status.

– Color indicators of therapy protocol, pump

operating status, and alarms/alerts.

• Immediate access to patient data to assist

with patient assessment with on-screen color
graphs and trending data:

– Unique graphs, trend reports and user

audit trail facilitate patient-centered care
management and promote continuous
quality indicators (CQI) processes.

– Reports include: given and PCA dose

counters, PCA dose graph, delivery
history and pie chart, delivery log, event
log, protocol summary library, device
information.

• Human factors design testing to help ensure

ease-of-use:

– Rigorous testing and analysis resulting in

an intuitive design with easy to operate
controls and high contrast display to help
save time and lower the risk of user error.

• Versatile administration set options:

– Smiths Medical offers a wide variety of

CADD® administration sets, featuring
exclusive medication cassette reservoirs to
promote patient mobility.

9

General Description

ScalableConnectivity—The flexible architectural
platform is ideal to grow with your evolving clinical
and technology road map.

• Flexible design supports future point of care

expansion needs:

– Unique platform provides immediate

clinical care benefits and flexibility to
sustain our vision of evolutionary IT
infrastructure needs.

– Promotes maximum patient safety,

personalized therapy for patient needs,
supports best practices and enables
continuous quality improvements.

Additional features of the CADD®-Solis ambulatory
infusion system:

• Use with CADD®-Solis Medication Safety

Software to optimize capabilities:

– Use with CADD®-Solis Medication

Safety Software to optimize medication
delivery safety features and comprehensive
management and analysis capabilities of the
CADD®-Solis ambulatory infusion system.

• Firmware design highlights:

– TALL/short man display style along with

units of measurement and/or concentration
promotes added safety.

– Status bar displays reservoir volume

status, delivery status, and power status
at all times, unless there is an alarm/alert
condition, and each indicator is color-coded
green, amber or red for an immediate visual
indication of pump operating status.

– Screen title bar with help text helps the user

easily identify their location in the pump
menu.

– Alarm/alert screens are color coded to low,

medium, and high priority conditions.

– Therapy, qualifier, drug, concentration/

units, and keypad lock status displayed at
all times except when viewing reports or
during alarm/alert conditions.

– Print bar codes and prescription forms.

• Hardware design highlights

– Cassette latch designed to help easily attach

the medication cassette reservoir.

– PCA dose @ key on pump for convenient

PCA dose availability while patient is
ambulatory.

– Remote PCA dose cord with LED

ergonomically designed to facilitate patient’s
ease of use.

– Agile polemount bracket adapter attached

to back of pump enhances visibility on IV
pole.

– Three power sources offer versatile

and economic options: 4 AA batteries;
rechargeable battery pack, and AC power.

– Integral air-in-line detection to notify user

of presence of air-in-tubing.

– PM (preventative maintenance) reminder

available.

– Splash proof (IPX4) moisture protection.

• Additional highlights

– User-friendly, easy-to-teach programming/

navigation menu may help shorten staff in­service time and promotes patient bedside
care.

– Three levels of customizable security

access levels: keypad code; clinician code;
administrator code, allows facility to
designate user access.

– Cassette/keypad lock promotes added

safety.

– On-board library holds up to 500 therapy

protocols.

– Adjustable alarm/alert volumes to meet

specific clinical setting needs.
– Event log holds up to 5,000 events.
– Clinical, technical, and implementation

support are offered 24/7 by Smiths Medical.

10

General Description

Pump Diagram Description of the Keys,

Components, Ports, and Connectors

Front View

Battery Compartment

Display

Indicator Lights

Amber

Green

USB Port

Blue AC
Power Light

AC Power Jack

Remote
Dose Cord
Jack

Keypad

Indicator Lights

When the pump is powered, one or both of the
indicator lights will flash.

Green: The green light flashes to indicate

that the pump is running and delivering fluid
as programmed.

Amber: The amber light flashes when the

pump is stopped, an alarm condition exists,
or the battery or the reservoir volume is low.
It stays on continuously when the pump is
inoperable. The display will briefly describe
the alarm condition when the amber light is
flashing.

NOTE: At times both lights may flash. This
indicates that the pump is running, but there
is a condition the clinician should be aware of
(e.g., low battery or low reservoir volume).

Rear View

Power Switch

Cassette/Keypad Lock

(Unlock/Lock)

Cassette Latch

Display with backlighting

The liquid crystal display (LCD) shows
programming information and messages.
Backlighting helps keep the display visible in low
light. In this manual, “display” is synonymous with
display panel or LCD.

After a period in which no keys are pressed, the
backlighting turns off and the display goes blank
to save battery power (except during an alarm or
when an external power source is in use). You may
press any key to turn the display back on.

NOTE: When the display is blank, you can
determine that the pump is powered by observing
either the green or amber (or both) LED indicators
periodically flashing.

NOTE: If you press stop/start 9, the display will
reappear with a message asking if you wish to start
or stop the pump.

Cassette (the part
of the medication

cassette reservoir

or CADD®

administration set

that attaches to

the pump)

NOTE:If you press PCA dose @ while the pump
screen is blank, the pump will deliver a PCA dose,
if available.

11

General Description

Keypad

The keys on the keypad are described below. A key
beeps when pressed if it is operable in the current
state of the pump. However, the keys will not beep
if the key beep function has been turned off in the
protocol or the administrator settings.

 





 Starts and stops pump delivery.

 Allows you to answer a question on the pump’s

display. For example, the screen above this
key may display “Yes,” in which case pressing
this key would give the question displayed
on the screen an answer of “Yes.” Also allows
you to navigate through some of the pump’s
screens (e.g., canceling an action, opening the
reports/tasks menus, or backing out of an open
screen). Referred to as “soft keys.”

Allows you to navigate through the menus on



the pump, scrolling down.

Allows you to navigate through the menus on



the pump, scrolling up.







USB Port

A mini-B USB cord can be attached to the USB
port for communications with the CADD®-Solis
Medication Safety Software.

Remote Dose Cord Jack

The remote dose cord jack is used for attaching the
remote dose cord. (See Remote Dose Cord on page 16
for more information.)

Battery Compartment

Four AA batteries or the rechargeable battery pack
fit into this compartment. The batteries serve as the
primary source of power, or as a backup when the
AC adapter is in use. (See Installing the Batteries
on page 14 for information on how to install the
batteries.)

Cassette Latch

This is used to attach the cassette to the pump.
When the pump is turned on, it will detect whether
the cassette is latched properly. Delivery will stop
and an alarm will occur if the cassette becomes
unlatched. (See Attach a Cassette on page 18 and
Remove a Cassette on page 19.)

Cassette/Keypad Lock

Used to select a menu item.

Allows the patient to request a PCA dose, if



the remote dose cord is not connected. If the
remote dose cord is connected this key will be
inactive.

Power Switch

Turns the pump on or off. Press and hold the switch
to turn the pump on. Press the switch to turn the
pump off and confirm that you want to power down
by selecting Yes.

Power Jack

You may plug the AC adapter into the power jack.
When the AC adapter is plugged in, the blue power
light turns on. This light is on regardless of the
pump’s on or off status. (See Desktop AC Adapter on
page 15 for more information.)

This allows you to secure the cassette to the pump
using the pump key provided. The cassette latch
must be latched before it can be locked. The
cassette/keypad lock can be configured to unlock
only the cassette latch or to unlock the cassette latch
as well as the keypad. This is configured by your
CADD®-Solis system administrator. (See Security
Settings on page 21.)

12

Delivery Methods

The pump provides the following methods of delivery:

• Continuous Rate (see page 30).

• PCA Dose (see page 30).

• Clinician Bolus (see page 22).

Clinician Bolus
(used here as a
loading dose)

PCA Doses

Dosage

General Description

Continuous Rate

Time

13

Pump Setup

Pump Setup

Installing the Batteries

AA 1.5 volt primary (non-rechargeable) alkaline
batteries or the Smiths Medical rechargeable battery
pack are recommended for use in the CADD®-Solis
pump.

NOTE:Smiths Medical does not recommend
mixing new and used batteries; doing so may affect
low battery alarm times. Always select four new
batteries when replacing them.

CAUTION:InspecttheAAbatteriesfordamage

or wear to the metal or plastic insulation prior to
use, or aer the pump has been dropped or hit.
Replace the batteries if any damage is noted.

The pump retains all programmed values while the
batteries are removed. The pump’s batteries must be
in place during delivery. If the batteries are removed
while the pump is delivering, and an AC adapter is
connected, delivery will stop. If an AC adapter is not
connected and the batteries are removed, delivery
will stop and the pump will lose power.

Dispose of used batteries in an environmentally safe
manner, and according to any regulations which
may apply.

• Always check the battery compartment for uid

or debris before inserting the batteries and do
not allow any uid or debris to fall into the
battery compartment. Fluid or debris in the
battery compartment may damage the battery
contacts and could result in loss of power and

nondeliveryofdrugand,dependingonthetype

of drug being administered, could result in
death or serious injury to the patient.

• 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 batteries will not be properly
secured; this may result in loss of power,

nondeliveryofdrugand,dependingonthetype

of drug being administered, could result in
death or serious injury to the patient.

Toinstallthebatteries:

1. Make sure the
pump is stopped
or powered off.
Using your fingers,
the pump key, or a
coin, turn the knob
on the battery door
counter-clockwise and open the battery door.

WARNING:

• Do not use rechargeable NiCd or nickel metal

hydride (NiMH) batteries. Do not use carbon

zinc(“heavyduty”)batteries.eydonot
providesucient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.

• ere is no pump alarm to alert users that a

battery has not been properly installed. An
improperly installed battery could result

inlossofpowerandnondeliveryofdrug

and, depending on the type of drug being
administered, could result in death or serious
injury to the patient.

2. Hold the pump at an
angle and place 4 AA
batteries in the pump,
from the bottom up
(see picture). Match
the + and - markings
on the new batteries
with the markings on
the pump.

OR: If using a
rechargeable battery
pack, insert it into the
pump as shown.

14

Pump Setup

3. Close the battery door and using your fingers,
the pump key, or a coin, turn the knob on the
battery door clockwise to lock.

NOTE: If you put the batteries in backwards, the
pump will not power up. Check the batteries,
making sure to match the + and - markings.

CAUTION:Donotstorethepumpforprolonged

periods with the batteries installed. Battery
leakage could damage the pump.

NOTES:

• Battery life is dependent on the amount of

medication delivered, delivery rate, battery
age, temperature, active display time, and
backlight intensity.

• The power of the battery will be quickly

depleted at temperatures below 10°C (50°F).

Replacing the battery door

If the battery door
is removed or needs
replacing, simply snap the
door onto the bar that is
located on the pump (see
picture).

Power Up

• After the power up is completed, listen for

the Morse Code “OK” sound (a series of six
audible beeps). If you do not hear this sound,
there may be a problem with the audible
alarms. If you believe there is a problem,
remove the pump from service and contact
Smiths Medical Customer Service.

• If any issues are found while the pump is

performing the self tests, alarms will sound
(e.g., if the battery is low or a key on the
keypad is stuck in the pressed position).

CAUTION:Ifthepowerupresultsinanerror

message indicating that the protocol library
was lost, do not proceed with using the pump.
Follow your facility’s procedures for downloading
protocol libraries.

Description of pump accessories

CAUTION:Onlyuseaccessoriesthatarespecied

for use with the CADD®-Solis ambulatory
infusion pump.

CADD®-Solis Medication Safety Software

The CADD®-Solis Medication Safety Software
allows you to create and manage protocol libraries
and then import them into the pump. See the
installation guide and help files that come with the
system for more information.

Press and hold the power switch to turn the pump
on. The pump will start the power up sequence
during which it will perform various self-tests,
test for alarm conditions, and then ask you if you
want to start a new patient. Watch for the following
during power-up:

• Both the green and amber indicator lights will

flash.

• The display will quickly flash gray, then blue.

An amber swirl will then fill the display,
followed by a CADD®-Solis Ambulatory
Infusion System display. Look for any stripes
or black or white pixels, which would indicate
a faulty display. If you see any indication of a
faulty display, remove the pump from service
and contact Smiths Medical Customer Service.

Desktop AC Adapter

The desktop AC adapter can be used as an alternate
source of power for the pump and/or to recharge the
rechargeable battery pack. The pump requires that
4 AA batteries or the rechargeable battery pack are
installed as a backup while using the AC adapter.
You can obtain a desktop AC adapter through the
Customer Service department at Smiths Medical.
See the desktop AC adapter’s instructions for use for
more information.

Rechargeable Battery Pack

The rechargeable battery pack is an alternate
to using four AA batteries and can be obtained
through the Customer Service department at Smiths

15

Pump Setup

Medical. The rechargeable battery pack can easily
be recharged with the AC adapter, either inside or
outside of the pump. See the rechargeable battery
pack’s instructions for use for more information.

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 pump:

• Medication cassette reservoir, used with a

CADD® extension set.

• CADD

WARNING: Follow the instructions for use

providedwiththeCADD™medicationcassette
reservoir,CADD® extension set, or 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.

administration set.

®

Polemount Bracket Adapter

The optional polemount bracket adapter attaches
onto the back of the pump. This allows you to attach
the pump to an IV pole. Refer to the instructions for
use provided with the polemount bracket adapter
for information.

Polemount Bracket

The polemount bracket is used along with the
polemount bracket adapter to attach the pump to an
IV pole. Refer to the instructions for use provided
with the polemount bracket for information.

Pump Key

The pump key is used to securely lock the cassette
to the pump. It can also be used to lock and unlock
the keypad, if allowed by the CADD®-Solis system
administrator.

NOTE: A CADD® set with free-flow protection
must be used in order to prevent free-flow.

NOTE: Smiths Medical recommends that the
appropriate supplies needed to replace the cassettes
are available in case of a damaged cassette.

NOTE: For detailed instructions and warnings
pertaining to the medication cassette reservoir
or CADD® administration set, please refer to the
instructions for use supplied with the product for
preparing the product for use.

Remote Dose Cord

The remote dose cord can be attached to the pump
and provided to the patient as an alternative to
pushing the PCA dose @ key when requesting
a PCA dose. The LED on the remote dose cord
indicates PCA dose status:

• Off: A PCA dose is not available.

• Flashing: A PCA dose is available.

• On: A PCA dose has been requested and

delivery has started.

Refer to the instructions for use provided with the
remote dose cord for more information.

16

Pump Setup

Programming the Pump: General
Instructions

The Pump Screen

The screen shots that you will see in this manual
are only examples of what might be displayed.
The protocols (consisting of therapies, qualifiers,
drugs and concentrations, and all associated pump
settings) in your pump library will be established by
your facility.

  









i



1)

1!

 The type of battery being used and the

approximate amount of life it has, as well as
AC indication.

Rechargeable
AA battery
source

Keypad lock status—locked or unlocked. In



battery source

Battery with AC
Adapter—may be
AA or rechargeable
battery

this example, the keypad is locked.

iThe units of measurement (mL, mg, or mcg)

and the concentration (if units are mg or
mcg) for the current protocol.

The name of the screen displayed and help



text for the screen, if there is any. This
screen, for example, is the home screen.

The work area/contents for the screen being



displayed (in this example, the patient
specific parameters are on display).

Options for navigating the pump. These



options will change depending on the screen
you are on and what functions you are
performing with the pump.

The therapy, qualifier, and drug from the



current protocol.

The status bar shows the status of the pump. It

also displays messages and alerts, for example,
if you locked or unlocked the cassette/keypad
lock or the keypad, attached a cassette, or
reached delivery limit.

The current value of the reservoir volume.



 The color of the screen is dependent on how

the protocol was set up in the CADD®-Solis
Medication Safety Software. If the screen color
is black, the protocol has been modified in the
administrator settings (see the Administrator
Settings Guide for more information) or the
pump is in manual mode (see Manual Mode
Programming on page 32).

The delivery status of the pump—stopped or



running.

Color Display

The CADD®-Solis pump display uses color to
help the clinician recognize critical information
quickly and easily. For example, your facility may
choose to relate a specific color to each protocol in
its library. This is customizable by your CADD®­Solis system administrator. Protocols may be
color coded in several different ways depending
on the needs of your pain management program,
including:

• Routeofadministration(e.g.,allepidural

protocols may be yellow and used with a
pump with a yellow keypad, yellow cassette
reservoir or administration set, yellow
extension set, and a yellow lockbox).

• Patienttype(e.g.,allpediatricprotocolsmay
be blue).

Or by any other hierarchy which fits the needs
of your institution. There are five protocol colors
available. The color of the protocol is displayed

17

Pump Setup

in the protocol title bar () as well as the soft key
bar (). A protocol displayed in black signifies that
the protocol being used is a non-standard protocol
or that the pump is programmed using the manual
mode (see Manual Mode Programming on page 32).
Refer to your facility’s policies and procedures to
understand how colors will be used to identify your
protocols.

The pump also uses color to help the clinician
recognize the pump’s status. The colors blue, green,
amber, and red are used in the status bar as well as
on alarm screens.

Similar to a traffic control light: green means go,
amber indicates caution, and red means stop:

• Green—indicates the conditions in the pump
are good (e.g., the reservoir volume is above
the low reservoir trip point).

• Amber—indicates there is a condition to
watch, but the current conditions of the pump
are satisfactory (e.g., the low reservoir trip
point has been reached).

Attach a Cassette

Obtain a new, filled medication cassette reservoir, or
CADD® administration set attached to a flexible IV
bag. Refer to the instructions for use supplied with
the product for information on preparing the
product for use.

CAUTION: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.

To attach the cassette to the pump:

1. Make sure the cassette latch
is unlocked and open the
cassette latch.

• Red—indicates a warning condition that
requires immediate attention and that the
infusion has stopped (e.g., the reservoir
volume has reached zero).

The color blue is also used in the status bar to give
informational messages (e.g., remote dose cord
attached).

To understand how colors relate to alarm screens,
refer to the alarms and messages section on p. 36.

Before Programming

Protocol libraries are created with the CADD®-Solis
Medication Safety Software and can be imported
into the pump by your CADD®-Solis system
administrator. Before programming the pump for
a patient, make sure the pump contains a protocol
library. If you are not using the CADD®-Solis
pump with a protocol library, see Manual Mode
Programming on page 32.

A protocol from the library may be manually edited
in the administrator settings. If you are authorized,
see the Administrator Settings Guide or contact
your facility’s CADD®-Solis system administrator for
further information.

2. Clamp the tubing.
Insert the cassette
hooks into the hinge
pins on the bottom
of the pump.

3. Holding the pump
in your hands, push
down on the cassette
latch, and push up
on the cassette until
it firmly clicks into
place.

4. Lift the cassette latch
into the closed
position. A message
will briefly appear in
the status bar so you
can verify the type
of cassette you have
attached.

18

Pump Setup

5. Insert the pump key
into the cassette/
keypad lock and turn
clockwise into the
locked position.

NOTE: The cassette
must be locked in
order to start the
pump. “Cassette Locked” will
appear briefly in the status bar.

WARNING: Attach the cassette properly. A

detached or improperly attached cassette

couldresultinunregulatedgravityinfusionof

medication from the uid container or a reux
of blood, which could result in death or injury
to the patient.

If you are using a CADD® administration set or

CADD™medicationcassettereservoirthatdoes
nothavetheowstopfeature: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.

Unregulatedgravityinfusioncanresultin

death or serious injury.

“Cassette Unlocked” will briefly appear in the
status bar.

3. Push down on
the cassette latch
until the cassette
detaches.

Start the Pump

Starting the pump starts delivery. When the
pump is running, “Running” will appear with
green highlighting on the status bar and the green
indicator light will flash. If the pump will not start,
a message will appear on the display. Refer to the
Alarms and Messages table on page 36.

NOTE: Before starting the pump, ensure correct
protocol and patient specific parameters are
displayed (see Patient Specific Parameters page 29).
Also be sure the tubing is primed and the pump is
connected to the patient, according to your facility’s
standards of practice.

To start the pump:

1. Press stop/start 9.

Remove a Cassette

Make sure the pump is stopped before removing the
cassette.

WARNING: Per general rules of safe practice,

alwaysclamptubingbeforeremovingthe
cassettefromthepump.Removingthecassette

without closing the clamp could potentially

causeunregulatedgravityinfusion,which

could result in patient injury or death.

To remove the cassette:

1. Close the tubing clamp.

2. If locked, insert the
pump key and turn the
cassette/keypad lock
counter-clockwise into
the unlocked position.

NOTE: If the patient
specific parameters have
not been reviewed and
the values have not been
accepted, the pump will
require you to do so
before the pump will run.

2. When “Start Pump?”
appears, select Yes.

Press here to select

19

Pump Setup

Stop the Pump

Stopping the pump stops delivery. When the
pump is stopped, “Stopped” will appear with red
highlighting on the status bar and the amber
indicator light will flash, while the green indicator
light will be off.

To stop the pump:

1. Press stop/start 9.

NOTE: If a PCA dose
or clinician bolus is in
progress, “Stop PCA
dose?” or “Stop clinician
bolus?” will appear. Select
Yes to stop the dose.

Press here to select

2. When “Stop Pump?”
appears, select Yes.

Press here to select

20

Programming and Operation

Programming and Operation

Security Settings

The security settings are used to limit patient and clinician access to certain programming and operating
functions of the pump. The various functions of the pump are protected by three different security codes,
and may also be protected by the cassette/keypad lock. The security level table below lists the functions that
are available under each security code. The factory default settings for the security codes are as follows:

** Text omitted from online version ** Administrator Code: See your CADD®-Solis system administrator.

The keypad code, clinician code, and administrator code can all be customized by the CADD®-Solis system
administrator while setting up the protocol using the CADD®-Solis Medication Safety Software, or in the
administrator settings. The CADD®-Solis system administrator also determines whether or not to allow
use of the cassette/keypad lock to unlock the keypad. See your CADD®-Solis system administrator for more
information or to learn the security code you should use if the codes have been customized.

Security Level Table

The keypad code should be used by clinicians who need to set up and manage a protocol for a patient. The
clinician code will allow access to all the functions the keypad code allows, as well as the clinician bolus
feature. The administrator code will allow access to all functions of the pump and its use should be restricted
to the CADD®-Solis system administrator and certain designees. The administrator code gives the user the
ability to change protocol ranges and all settings in the pump.

Keypad Security Locked Keypad Security

Pump Operations

and Programming

Stop/Start
Reset Reservoir Volume • • •
Start PCA Dose • • • •
Change (Titrate) Continuous Rate • • • • • •
Change (Titrate) PCA Dose • • • • • •
Change (Titrate) • • • • • •
Change (Titrate) Delivery Amount • • • • • •
Change (Titrate) Max Doses/Hr • • • • • •

Pump Tasks

Give Clinician Bolus
Start New Patient • • •
Start New Protocol/Same Patient • • •
Prime Tubing • • •
Set Time and Date • • •
Adjust Backlight Intensity • • • • • •
Adjust Alarm Volume • • • • • •
View/Clear Reports • • • • • • • •
Access Administrator Settings •

Running Stopped Running Stopped Running Stopped Running Stopped

• • • • • • • •

Keypad Security Locked Keypad Security

Running Stopped Running Stopped Running Stopped Running Stopped

Unlocked

Unlocked

Clinician Security

Unlocked

Clinician Security

Unlocked

• •

Administrator

Security Unlocked

Administrator

Security Unlocked

Security Level Table Key

Yes

•

No

21

Programming and Operation

Autolock

The CADD®-Solis pump has been designed to
meet both safety and usability needs. The autolock
feature reduces the chance of non-authorized pump
programming.

When the keypad is unlocked using the security
code and left unlocked (pushing the right soft
key twice from the home screen will ensure that
the pump has been locked), the software will
eventually lock the keypad. This autolock feature
takes affect on the home screen approximately 30
seconds after the last key press. It will take longer
on programming or task screens where the user
typically needs more time to perform an action
(Depending on which screen the pump was left on,
it will take up to 4.5 minutes after the last key press,
if the pump is not alarming. When the pump is
alarming the autolock does not take affect).

If using the key to unlock the keypad while the
pump is running, you will be able to edit the
program values. You should then relock the keypad
using the key.

NOTE:The keypad can always be re-locked by
pushing the right soft key twice from the home
screen (or once from the tasks menu). As a
recommended safety precaution, always be sure to
manually lock the pump using this feature.

• Adjust Alarm Volume

• View Reports

• Adjust Admin Settings

Depending on the level of security required and how
the CADD®-Solis system administrator has set up
the protocol, you may be able to use the cassette/
keypad lock to unlock the keypad. When a code or
the pump key is required, the pump will always ask
for it with one of the following screens:

To unlock the keypad with the pump key, turn the

or

pump key counter-clockwise
to put the cassette/keypad lock
in the unlocked position.

NOTE: It is possible for the
keypad to be locked while
the cassette/keypad lock is
unlocked. To use the pump
key to unlock the keypad, first
lock the cassette/keypad lock,
and then unlock it.

To access the tasks menu,
select Tasks on the home
screen.

Tasks

The tasks menu will lead you to most of the pump’s
operating functions. On this menu, you can perform
a range of tasks from giving a clinician bolus,
starting a new patient, to changing the date and
time, or adjusting the administrator settings. Some
of the items on the tasks menu are protected by the
various security levels. To learn more about the
security codes, see Security Settings on page 21.

The following functions can be found on the tasks
menu:

• Give Clinician Bolus

• Start New Patient

• Start New Protocol, Same Patient

• Prime Tubing

• Set Time and Date

• Adjust Backlight Intensity

22

Press here to select

Give Clinician Bolus

A clinician bolus may only be delivered while the
pump is running. It allows you to deliver a specified
amount of drug, for example, as a loading dose. A
clinician bolus cannot be started while a PCA dose
is in progress. The amount delivered decreases the
reservoir volume and increases the given amount,
but does not add to the dose counters or to the
delivery limit. A clinician bolus may be stopped in
progress.

NOTE: If a clinician bolus is manually stopped by
a clinician or automatically stopped by an alarm,
power failure, or other condition that stops delivery,
the pump will remember what point the bolus was
at when it stopped. The next time you choose to give

a clinician bolus, it will give you the option to restart
the clinician bolus where it left off or to start with a
new clinician bolus.

WARNING: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.

Improper programming could result in serious
patient injury or death.

NOTE: The maximum clinician bolus may be limited
by the settings in the protocol, which is determined
by the CADD®-Solis system administrator.

To start a clinician bolus:

1. Make sure the pump is running. Start the pump
if necessary.

2. From the Tasks menu,
press U or D until
GiveClinicianBolusis
highlighted, then press
S.

3. Unlock the keypad using
the pump key (if allowed)
or press U or D to
enter the clinician code
(or a higher level code).
Press S to advance to
the next digit. Once the
code has been entered,

Press here to Accept Value

select Accept Value.

NOTE: If you enter a
code that you believe
is correct and receive
a wrong code error,
check the screen to see
if the clinician code
has been customized.
If the code has not been customized, it was
entered incorrectly. Retry. If the code has been
customized, use the custom clinician code.
If you do not know this code, contact your
CADD®-Solis system administrator.

Programming and Operation

WARNING:Topreventthepatientfrom

accessing the clinician bolus function, do
not let the patient know the security codes.
Improper programming could result in
serious patient injury or death.

4. Make sure the clinician
bolus amount is at the
desired value and select

Deliver.

NOTE: If you enter a

value outside the soft
limit, a screen will
appear asking you to

Press here to Deliver

confirm the soft limit
override.

5. The screen will show the
amount decreasing as the
bolus is delivered. You
may stop the bolus at any
time by selecting Stop
Bolus.

Press here to Stop Bolus

WARNING:Neverleavethepumpunattended

while on the clinician bolus edit screen. You

mustpress“Confirm”or“Deliver”todeliver
theprogrammedvalueorcanceltoleavethe

screen. Failure to do so could result in serious
patient injury or death.

Start New Patient

Each time a new patient is started, it will be
recorded in the event log. All other reports will be
cleared.

The pump must be stopped and you’ll need the
keypad code (or a higher level code) or the cassette/
keypad lock must be unlocked, if allowed. To start a
new patient:

1. From the Tasks menu,
press U or D until
Start New Patient is
highlighted and press
S.

23

Programming and Operation

2. Unlock the keypad using the security code or
the pump key.

3. Press U or D to
highlight the desired
therapy and press S.

4. Press U or D to
highlight the desired
qualifier and press S.

5. Press U or D to
highlight the desired
drug and concentration,
and press S.

6. The new protocol will
display on the screen and
the pump will ask you
if you have chosen the
correct Therapy, Qualifier,
Drug, and Concentration.

Confirmthatyouhave

selected the correct

Press here to select

Therapy,Qualifier,Drug,

and Concentration or Units.

NOTE: If programming in mL, you will not be
asked to confirm the concentration.

Selecting Yes will program the pump with the
protocol you have chosen.

Selecting No will bring you back to the Select
Drug screen. If you desire to change the drug,
repeat the process for selecting a new drug.
Otherwise, select Back until you reach the screen
you desire to change (therapy or qualifier).

Start New Protocol, Same Patient

The process for starting a new protocol for the same
patient is much like starting a new patient; however,
the event log does not insert a new patient marker
(all other reports will be cleared, except the delivery
log). See Start New Patient on page 23 for directions

on selecting a therapy, qualifier, and drug for the
new protocol.

NOTE: When starting a new protocol, be sure to
attach a new reservoir with the proper drug and
concentration.

Prime Tubing

Priming the tubing is done to fill the tubing
downstream of the pump with fluid, removing any
air bubbles. Prime the tubing before connecting it to
the patient’s infusion set or indwelling catheter. The
pump must be stopped and you’ll need the keypad
code (or a higher level code) or the cassette/keypad
lock must be unlocked.

NOTE: The air detector is disabled while the pump
is priming.

WARNING: Do not prime the uid path with

the tubing connected to a patient as this could

resultinoverdeliveryofmedicationorair

embolism, which could result in serious patient
injury or death.

To prime the tubing:

1. From the Tasks menu,

press U or D until
PrimeTubing is
highlighted and press
S.

2. Unlock the keypad using the security code or
the pump key.

3. If you have not already
done so, disconnect the
tubing from the patient,
open clamps, and select
Prime.

Press here to select

You may stop priming

at any time by selecting
Stop Priming. Otherwise
priming will automatically
stop once it has primed
10mL. Continue priming
as needed.

Press here to stop

24

Programming and Operation

WARNING:Ensurethattheentirefluidpathis

free of all air bubbles before connecting to the

patienttopreventairembolism.Airembolism

could result in serious patient injury or death.

NOTE: If the fluid path contains an air
eliminating filter, it is acceptable for air bubbles
to be present on the vent side of the filter. See
the cassette’s instructions for use for more
information.

Set Time and Date

The set time and date screen allows you to edit the
time and date, as well as to choose a date format.
The date format options are Month/Day/Year or
Day/Month/Year.

The time option should reflect the current time.
The pump shows the time of day in 24-hour time
according to the pump’s internal clock. The clock is
powered by a separate, internal battery which retains
the time even when the 4 AA batteries or the battery
pack is removed. The pump uses its clock to record
the time of events in the delivery and event logs, as
well as in other reports.

The date option should reflect the current date. The
pump uses this feature to record the date of events
in the delivery and event logs, in other reports, and
to determine when the preventative maintenance
(PM) reminder alarms will occur.

NOTE: Protocol information will remain the same
regardless of changing the time and/or date during a
patient’s therapy.

To set the current time:

1. Press U or D

until CurrentTime is
highlighted and press
S.

2. Unlock the keypad using
the security code or the pump key.

3. Press U or D to
scroll to the correct
hour and press S to
navigate to the minutes.

4. Press U or D to
scroll to the correct
minutes and select Save.

Press here to Save

Updatingthetimeanddatetodaylightsavingstime.

The pump’s time and date will not automatically
update during daylight savings. If you live in a
geographical area that follows daylight savings time,
you will need to manually update the time and date.
You may choose to change the time while the pump
is currently being used by a patient, or to wait until
the patient is finished with therapy.

NOTE: If you update the pump’s time while it is
being used on a patient, the timestamps in the event
and delivery logs will not be updated to reflect
daylight savings prior to the change. All events
will record the reported time from when the event
actually occurred. For your reference, the event log
will record the time it was changed.

The pump must be stopped and you’ll need the
keypad code (or a higher level code) or the cassette/
keypad lock must be unlocked.

To access the set time and date feature from the
tasks menu:

1. Press U or D to

choose SetTimeand
Date and press S.

To set the current date:

1. Press U or D
until Current Date is
highlighted and press
S.

2. Unlock the keypad
using the security code or the pump key.

3. Press U or D to scroll to the correct month
and press S to navigate to the day.

25

Programming and Operation

4. Press U or D to

scroll to the correct
day and press S to
navigate to the year.

5. Press U or D to

scroll to the correct year
and select Save.

Press here to Save

To set the date format:

NOTE: You cannot change the date format without
the administrator code.

1. Press U or D

until Date Format is
highlighted and press
S.

2. Unlock the keypad
using the administrator
code.

3. Press U or D to
choose either the
Month/Day/Year format
or the Day/Month/Year
format and select Save.

Press here to Save

3. Press U or D to

scroll from 1 to 10. The
pump will display the
intensity of each number
as it appears. Once you
have found the desired
backlight intensity, select
Save.

Press here to Save

Adjust Alarm Volume

The adjust alarm volume feature allows you to
determine the volume of the alarms in the protocol.
You may choose between 3 volumes: low, medium,
and high.

To adjust the alarm volume from the tasks menu:

1. Press U or D to

choose Adjust Alarm
Volume and press S.

2. Unlock the keypad
using the security code
or the pump key.

3. Press U or D to
choose Low, Medium, or
High and select Save.

Adjust Backlight Intensity

The backlight intensity feature allows you to adjust
the backlight intensity within the range of 1 to 10.

NOTE: Increasing the backlight intensity will
shorten the battery life.

To adjust the backlight intensity from the tasks
menu:

1. Press U or D

to choose Adjust
Backlight Intensity and
press S.

2. Unlock the keypad using the security code or
the pump key.

26

Press here to Save

View Reports

The reports screen is used to access a variety of
reporting and record-keeping functions.

To access reports from the tasks menu:

1. Press U or D to

choose View Reports
and press S.

NOTE: Reports may
also be accessed from
the home screen.

See Reports on page 27 for more information.

Programming and Operation

Adjust Admin Settings

The administrator settings contain pump
configurations that are set up by the CADD®-Solis
system administrator. Protocol libraries are created
using the CADD®-Solis Medication Safety Software.
The administrator settings only allow you to make
changes to the protocol currently displayed.

To access the administrator settings:

1. From the tasks menu,

Press U or D to
choose Adjust Admin
Settings and press S.

NOTE: You cannot
access the administrator
settings without the administrator code.

See the Administrator Settings Guide for more
information.

• PCA Doses Attempted shows the total

number of PCA doses attempted by the patient
while the pump was running, including those
that were delivered, locked out, and stopped in
progress.

The dose counters can be viewed or cleared while
the pump is running or stopped.

NOTE: If the PCA dose is not available in the
current protocol and has been programmed to not
be visible on the home screen, you will only see the
“Total Given” when viewing this report.

To view the given and PCA dose counters:

1. From the reports menu,

press U or D to
choose GivenandPCA
Dose Counters and
press S.

Reports

The reports screen is used to access a variety of
reporting and record-keeping functions.

You may access the reports
from the home screen or
the tasks menu. To access
the reports from the home
screen, select Reports.

(To access the reports from
the tasks menu, see “View
Reports” in the previous
section.)

Given and PCA Dose Counters

This screen shows the number of PCA doses given
and attempted since the date and time indicated,
which is the last time they were cleared manually, or
when a new protocol or new patient has been started.

• TotalGivenshows the amount of drug (in

programming units) that has been given in
continuous rate, clinician boluses, and PCA
doses.

• PCADosesGiven shows the number of

PCA doses actually delivered to the patient,
including any doses stopped in progress.

Press here to select

To clear the total given:

1. Press U or D until

the Total Given section
is highlighted.

2. Select ClearGiven.

Press here to select

To clear the PCA doses given and attempted:

1. Press U or D until

the PCA Doses Given
and Attempted section
is highlighted.

2. Select Clear Doses.

Press here to select

27

Programming and Operation

PCA Dose Graph

This screen displays the
number of doses attempted
and given in 30 minute
increments starting from
the current time to 8 hours
in the past or to the start of
a new protocol or patient.

In this example, the patient has attempted 7 doses
and 2 of those doses were given.

This is a good place to review the number of
attempted doses for a particular time frame.

The PCA dose graph can be viewed at any time,
with the pump running or stopped.

To view the PCA dose graph:

1. From the reports menu,
press U or D to
choose PCA Dose
Graph and press S.

Delivery Log

The delivery log is a subset of the event log and
contains information having to do specifically with
delivery events. Delivery log information includes:

• PCA dose deliveries.

• Clinician boluses.

• Changes to the patient specific parameters

(including continuous rate, PCA dose, PCA
dose lockout, delivery limit).

• Manually stopping a PCA dose and/or a

clinician bolus.

• Starting a new protocol.

• Pump started, stopped, powered up, and

powered down.

The delivery log is maintained by the pump, and
displays all entries since the last time a new patient
was started. The delivery log can be viewed at any
time, with the pump running or stopped.

To view the delivery log:

Delivery History and Pie Chart

The delivery history and pie
chart is a pie chart view
of the total given over a
specified time frame or to
the start of a new patient or
protocol. The time frame
can be adjusted in various
intervals from 30minutes
to 7 days.

Press U or D to view the time chart in the
various time frames. This will provide a quick
review of the methods of delivery over the interval
selected.

The delivery history is displayed in the units for the
current protocol.

The delivery history and pie chart can be viewed at
any time, with the pump running or stopped.

To view the delivery history and pie chart:

1. From the reports
menu, press U or D
to choose Delivery
History and Pie Chart
and press S.

1. From the reports menu,

press U or D to
choose DeliveryLog
and press S.

While viewing the delivery log, you may quickly
scroll from the oldest to newest by selecting Show
Oldest or Show Newest.

Event Log

The event log records the following types of events:
hourly given totals, dose delivery, alarms, error
codes, power source changes, cassette changes,
protocol library changes, and changes to pump
programming or settings. The pump records the
time and date of each event, and lists events in order,
with the most recent at the bottom of the screen
through the last 5000 events.

The event log can be viewed at any time, with the
pump running or stopped.

28

Programming and Operation

To view the event log:

1. From the Reports

menu, press U or D
to choose EventLog
and press S.

While viewing the event log, you may quickly scroll
from the oldest to newest by selecting Show Oldest
or Show Newest.

Protocol Library Summary

The protocol library summary allows you to view
the protocol library currently installed in the pump.
This screen will tell you the name of the protocol
library, the revision, and the number of protocols in
the library.

To view the protocol library summary:

1. From the reports

menu, press U or D
to choose Protocol
Library Summary and
press S.

Device Information

Patient Specific Parameters
(Programming Screens)

The patient specific parameters are found on
the home screen and can be edited within limits
that are set up by the CADD®-Solis system
administrator in the protocol. The CADD®-Solis
system administrator determines which parameters
can be viewed and/or edited on the home screen,
as well as the initial values of the parameters.
While determining the initial values, the CADD®­Solis system
administrator will
also set up hard
and soft limits
which may allow
you to modify
the parameters as
necessary. The soft limits (displayed in green) will
be the range most commonly used for the protocol,
and the hard limits (displayed in amber) extend to
the highest and lowest amount that the CADD®­Solis system administrator chooses to allow for
the protocol. If the doctor’s orders do not match
the initial values, they should be edited to match.
Editing the parameters above or below the soft
limits will result in a
screen that requires
you to confirm the
soft limit override.

Outside
soft limit
range
(amber)

Max. Hard
limit range
(amber)

Soft limit
range
(green)

Min. hard
limit range
(amber)

The device information
screen allows you to view
the pump’s information.
On this screen you will find
the pump’s serial number,
software and hardware
version numbers, and the
last error code (if one exists).

NOTE: Review your facility’s procedure for
handling error codes (see Understanding the Alarms
and Messages on page 35 for more information).

To view the device information:

1. From the reports

menu, press U or
D to choose Device
Information and press
S.

You will need the
keypad (or a higher
level) code or the pump key
to edit the patient specific parameters. The CADD®­Solis system administrator determines if the pump
key can be used to unlock the keypad when setting
up the protocol.

If the option is available, use the
pump key to place the pump
in the unlocked position (see
picture)

OR

Enter the keypad code
(see Security Settings on page 21).

NOTE: Using the pump key to unlock the keypad
also unlocks the cassette latch (see Attach a Cassette
on page 18 for more information).

29

Programming and Operation

NOTE: When using the pump key to unlock the
keypad, be sure to keep the cassette latch in the
latched position.

Continuous Rate

The continuous rate is the constant, hourly rate the
drug is delivered at while the pump is running.

The continuous rate value can be edited while
the pump is running or stopped (if the keypad is
unlocked).

To edit the continuous rate:

1. From the Home screen,
press U or D to
choose Continuous
Rate and press S.

2. Unlock the keypad
using the security code
or the pump key.

3. Press U or D until
you reach the desired
Continuous Rate and
select Save.

CADD

-Solis system administrator, the pump

®

will display the message, “PCA dose not available
because no dose programmed.”

The PCA dose amount can be edited while the
pump is running or stopped (if the keypad is
unlocked).

To edit the PCA dose:

1. From the Home screen,

press U or D to
choose PCA Dose and
press S.

2. Unlock the keypad using
the security code or the
pump key.

3. Press U or D until
you reach the desired
PCA dose and select
Save.

Press here to Save

Press here to Save

PCA Dose

A PCA dose is a bolus of drug delivered by the
pump in response to a request from the patient. The
patient either presses the PCA dose @ key on the
keypad or presses the remote dose cord button (if
attached) to request a PCA dose.

NOTE: If a remote dose cord is attached to the
pump, the PCA dose @ key on the keypad will be
inactive.

If the CADD®-Solis system administrator has
programmed a PCA dose into the protocol, the
patient may start a PCA dose while the pump is
running. The amount delivered is added to the
amount provided by the continuous rate. Each time
the patient requests a PCA dose, the pump will
automatically add it to the dose counters screen.
If a PCA dose has not been programmed by the

PCA Lockout

A PCA lockout is a program setting that specifies
the minimum amount of time that must pass
between the start of each PCA dose. If the patient
attempts to deliver a PCA dose during the lockout
time, “PCA dose not available. Currently locked
out.” will appear on the display and the pump will
not deliver the dose. The parameters for the PCA
lockout are determined by the CADD®-Solis system
administrator.

The PCA lockout time can be edited while the pump
is running or stopped (if the keypad is unlocked).

To edit the PCA lockout:

1. From the Home screen,
press U or D to
choose PCA Lockout
and press S.

2. Unlock the keypad using the security code or
the pump key.

30

Programming and Operation

3. Press U or D until

you reach the desired
PCA lockout time and
select Save.

NOTES:

If the delivery limit is reached while a PCA

•

Press here to Save

dose is in progress, the PCA dose will not be
completed.

A PCA dose cannot be started while another

•

PCA dose or a clinician bolus is in progress.

Pressing the remote dose cord button will turn

•

the display back on AND deliver a PCA dose
(if available). A blank display will not require
two key presses to start a PCA dose.

Hourly Limit

2. Unlock the keypad
using the security code
or the pump key.

3. Press U or D until
you reach the desired
hourly limit amount
and select Save.

Press here to Save

If the hourly limit is not visible on the home screen,
your CADD®-Solis system administrator has chosen
not to require it. Instead you may be required to
program the Max Doses/Hr.

Max Doses/Hr

If the max doses/hr setting is turned on, you may
use it to further restrict the number of PCA doses
available to the patient in 1 hour. The max doses/hr
feature allows you to restrict the PCA doses beyond
the PCA lockout time.

The hourly limit is the amount of drug which can be
delivered in a specified time frame (1-12 hours). The
time frame is determined by your facility’s CADD®­Solis system administrator. This limit includes
the continuous rate and PCA doses, but does not
include clinician boluses.

If the delivery limit is reached and a continuous rate
is programmed (value other than zero), the status
bar will display “Delivery Limit” and the pump will
deliver a KVO rate of 0.1 mL/hr. If the delivery limit
is reached and no continuous rate is programmed
(value=zero), the status bar will display “KVO = 0”
and the KVO rate will be zero.

NOTE: If the delivery limit is reached while a
PCA dose is in progress, the PCA dose will not be
completed.

The hourly limit can be edited while the pump is
running or stopped (if the keypad is unlocked).

To edit the hourly limit:

1. From the Home screen,

press U or D to
choose X* Hour Limit
and press S.

*X will be the number of hours set up by the CADD®-Solis system

administrator. In the example shown, a 4 hour limit is being used.

The max doses/hr time can be edited while the
pump is running or stopped (if the keypad is
unlocked).

To edit the max doses/hr:

1. From the Home screen,
press U or D to
choose Max Doses/Hr
and press S.

2. Unlock the keypad
using the security code
or the pump key.

3. Press U or D until
you reach the desired
max doses/hr value and
select Save.

Press here to Save

If max doses/hr is not visible on the home screen,
your CADD®-Solis system administrator has chosen
not to require it. Instead you may be required to
program the hourly limit.

NOTE: If the hourly limit and the max doses/hr
settings are not displayed on your programming
screen, your facility’s CADD®-Solis system
administrator has chosen not to require a delivery
limit beyond the PCA lockout.

31

Programming and Operation

Reservoir Volume

The reservoir volume is a program setting that
allows you to set the amount of fluid that is
contained in the reservoir. Once you set this
number, the software keeps track of how much fluid
has been delivered and adjusts the reservoir volume
accordingly.

The pump must be stopped, and the keypad
unlocked, to adjust the reservoir volume amount.

To edit the reservoir volume:

1. From the Home screen,

press U or D to
choose ReservoirVol.
and press S.

2. Unlock the keypad
using the security code or the pump key.

3. Press U or D until
you reach the desired
reservoir volume and
select Save.

You may press S
to reset the pump
to a default amount
which will appear
on the screen in blue
text, under the current value. In this example,
pressing S will reset the reservoir volume to
100 mL.

Press here to Save

Manual Mode Programming

The manual mode is for situations when the doctor’s
orders may not match any of the protocols in the
library, or when a protocol library is not available.
The screen for the manual mode will always be
black in color and the therapy, qualifier, and drug
and concentration listing will look like this (see page
17 for a diagram of the pump screen):

This will
display the
units and
concentration
chosen after
the manual
mode has been
selected.

NOTE: The protocol title bar may be black even
when the pump is not in manual mode if the
protocol has been modified in the administrator
settings (see the Administrator Settings Guide for
more information). Be sure to check the therapy,
qualifier, drug, and concentration or units displayed
to ensure you are in manual mode.

Unlike protocols that are created and downloaded
into the pump by the CADD®-Solis Medication
Safety Software System, the manual mode
allows you to choose the units (mL, mg, mcg)
and concentration, and does not contain any
programming limits. Many of the parameters in
the manual mode will remain the same as the
parameters from the previously used protocol. For
example, if the previous protocol had delivery limit
set as its delivery limit method, the manual mode
will also have delivery limit as its delivery limit
method. However, the actual programming limits of
the previous protocol will be erased. The hard and
soft limits are all set to the factory default, which
means the delivery ranges are not limited. See the
following chart for details.

32

NOTE: If the pump was set to the factory default,
or if you are using the pump for the first time, the
previously selected protocol is the factory default
settings. Refer to the table on page 52 to see what the
factory default settings are.

If you desire to set programming limits after
choosing the manual mode, you may do so. See the
Administrator Settings Guide for more information.

Programming and Operation

The following chart includes the initial settings of
the Manual Mode.

Pump Function What Changes in the Protocol

Programming Units User chooses mL, mg, or mcg

Concentration Range is 0.1–100 mg or/mL or

1–500 mcg/mL

Continuous Rate Range is 0–30 mL/hour (or mg or

mcg equivalent), Default 0

PCA dose Range is 0–20 mL (or mg or mcg

equivalent), Default 0

PCA dose lockout Range is 1 min–24 hours,

Default 1hr (when PCA dose is
programmed).

Delivery limit amount* Range is 0.1–1000 mL (or mg or

mcg equivalent)

Max doses/hour* Range is 1–60

Reservoir volume 1 mL

Reservoir volume reset
value

Delivery limit method Remains the same as the

Reservoir volume low
trip point

Reservoir low alarm
type

Clinician bolus amount Range is 0–20 mL (or mg or mcg

Delivery limit period Remains the same as the

Maximum delivery rate Remains the same as the

Pump stopped alarm
type

Upstream sensor on/off Remains the same as the

Downstream sensor
sensitivity

Air detector on/off Remains the same as the

Air detector sensitivity Remains the same as the

Time and date settings Remains the same as the

PM reminder on/off Remains the same as the

PM reminder interval Remains the same as the

Display and sound
settings

Security settings Remains the same as the

*Only if feature was used in the previous protocol.

100 mL

previously used protocol

5.0 mL

Remains the same as the
previously used protocol

equivalent)

previously used protocol

previously used protocol

Remains the same as the
previously used protocol

previously used protocol

Remains the same as the
previously used protocol

previously used protocol

previously used protocol

previously used protocol

previously used protocol

previously used protocol

Remains the same as the
previously used protocol

previously used protocol

To use the manual mode:

1. Determine whether you are starting a new
patient, or starting a new protocol with the same
patient. Select the appropriate task from the
tasks menu.

2. On the Select Therapy
screen, scroll to the
bottom of the therapies
until [Program
Manually] is highlighted
and press S.
The protocol title bar will be displayed in the
color black. Instead of a therapy and qualifier, you
will see the Manual Program screen (see page 32).

NOTE: You may need to enter a higher level
security code to proceed. If you do not know
which code to enter, contact your CADD®-Solis
system administrator.

3. Press U or D to
select the desired units
(mL, mg, mcg) and
press S.

If you selected mg or

mcg, press U or D
to select the desired
concentration and select
Confirm. If you selected
mL, proceed to the next
step.

Press here to Confirm

4. The therapy,
qualifier, units and
concentration, if
applicable, that you
have selected will
now appear. Confirm
that you have selected
the correct units and
concentration and
select Yes.

Press here to select

33

Programming and Operation

NOTE: If the information displayed is incorrect,
selecting the left soft key will back you out of
each screen, allowing you to start over.

5. The pump will take
a moment to set the
program before it asks
you to review the pump
settings. Select Review.

Press here to Review

6. Carefully review each patient specific parameter.

If the parameters are not at the desired
values, press S to edit. (See Patient Specific
Parameters on page 29 for more information.)

If the parameters are correct, select Accept Value.

NOTE: When the pump is in the manual mode,
only the factory default settings are considered
to be within the soft limits. If you edit any of the
parameters outside of the factory default, you
are exceeding the soft limit range and you will
be asked to confirm the soft limit override on
each screen (see page 52 for the factory default
settings). The parameter and value will be
displayed in amber.

WARNING:Themanualmodedoesnot

contain programming limits. Be sure to

carefullyrevieweachparametertoensureit

accurately matches the prescription. Failure

tosetthemanualmodetothecorrectvalues

could result in serious patient injury or death.

7. Once you have accepted each of the values,
follow the instructions on the pump to attach
the cassette, prime the set, and start the pump.

NOTE: The manual mode is designed to be used in
unusual circumstances when an order is received
which is different than any of your standard
protocols. Use of the manual mode does not allow
you to use all of the medication safety features built
into the CADD®-Solis pump. If you find the manual
mode is being used frequently, consider contacting
your CADD®-Solis system administrator to discuss
if additional protocols should be created.

34

References and Troubleshooting

References and Troubleshooting

Understanding the Alarms and
Messages

There are multiple alarms that the pump can
sound. Many of the alarms will give you the
option to “acknowledge” or “silence.” Choosing
to acknowledge the alarm will clear it from the
screen; choosing to silence the alarm will keep it
on the screen, but silence it for 2 minutes before
it sounds again. It will continue until the alarm is
acknowledged or resolved.

The alarms may sound different depending on the
sound theme selected in the administrator settings.
There are 3 different sound themes for the alarms
and beeps that the pump makes. The 3 themes
are standard, intense, and distinctive. See the
Administrator Settings Guide for more information
on previewing and selecting the sound themes.

The alarm/message types are as follows:

System Fault Alarm –

If this screen
appears, an
unrecoverable
error may have
occurred, such
as a hardware or
software fault. The
amber indicator
light will be continuously illuminated during these
conditions and is accompanied by an audible two­tone alarm. If a system fault occurs, the fault should
be reported to Customer Service at Smiths Medical
MD, Inc. at: 1800.426.2448 (USA) or Smiths
Medical International Ltd at: +44(0)1923246434.
To clear this alarm, you must remove power from
the pump by opening the battery door and, if
necessary, removing the AC power. Turn the pump
back on. If the error code does not repeat, Smiths
Medical Customer Service may suggest continued
use of the pump. However, if the error is persistent,
the pump will need to be returned for service.

CAUTION:Ifthepowerupresultsinanerrormessage

indicating that the protocol library was lost, do not
proceed with using the pump. Follow your facility’s
procedures for downloading protocol libraries.

(System Fault alarm

= red screen)

These
numbers
relate
to the
error that
caused
the
system
fault

NOTE: Document the error numbers displayed
on the system fault screen to help Smiths Medical
Customer Service identify the problem.

High Priority Alarm –

If the pump is running, it
will always stop running

(High priority alarm

= red screen)

when a high priority alarm
is activated. The alarm
is accompanied by a red
screen, and it will persist until acknowledged by the
press of a key on the pump or until the condition
that triggered the alarm goes away (e.g., high
pressure going down). The alarm can be silenced
with a key press and will sound again after 2 minutes
if the alarm condition still exists.

Medium Priority Alarm –

If the pump is running, a
medium priority alarm will

(Medium priority alarm

= amber screen)

not stop the pump. The
alarm is accompanied by
an amber screen, and it
will persist until acknowledged by the press of a key
on the pump or until the condition that triggered
the alarm goes away (e.g., a remote dose cord is
reattached while the pump is running). The alarm
can be silenced with a key press and will sound
again after 2 minutes if the alarm condition still
exists.

Low Priority Alarm –

If the pump is running, a
low priority alarm will not

(Low priority alarm

= blue screen)

stop the pump. The alarm
is accompanied by a blue
screen, and it will persist for
5 seconds, unless it is acknowledged by the press of
a key or the condition that triggered the alarm goes
away before the 5 seconds have passed.

Informational Message – If the pump is running,
an informational priority message will not stop the
pump. This message shows up in the status bar, it
does not display a new alarm screen. It will persist
for 5 seconds and is generally silent, requiring no
acknowledgement. Some informational examples
are, “Cassette Locked,” and “Cassette Unlocked.”

35

References and Troubleshooting

Alarms and Messages, Alphabetical List

Alarms and Messages Alarm Priority Description / Corrective Action

(Screen is blank and alarm is
sounding)

A setting was edited, but not
saved, and the edit was lost.

AC Adapter disconnected. Low The AC adapter was disconnected and the pump is being

Air in-line detected. Press
‘Acknowledge’ then prime
tubing.

Battery depleted. Pump
stopped.

Battery depleted. Pump will not
run.

Battery low. Replace battery. Low The rechargeable battery pack or the 4 AA batteries are low

High The pump was delivering and the batteries were removed or the

battery door was opened. The pump has lost power and is no
longer delivering. Clear this alarm by turning the pump back
on, or the alarm will stop after the power has been off for a
minimum of 2 minutes.

Medium A parameter was being manually edited, but it wasn’t saved and

the pump reverted to the home screen. Select acknowledge to
clear the alarm, and if appropriate, edit the parameter and save.

powered by the 4 AA batteries or the rechargeable battery
pack. Select acknowledge to clear the alarm or the alarm will
automatically clear after 5 seconds. If desired, reconnect the AC
adapter.

High The air detector has detected air in the fluid path; the f luid

path may contain air bubbles. The pump was delivering and is
now stopped and will not run. Select acknowledge to clear the
alarm, then:

• Ifthefluidpathcontainsairbubbles,closetheclampsand

disconnect the fluid path from the patient. Then follow the
instructions for removing air by priming (see Prime Tubing on
page 24 for more information on priming). Restart the pump.

High The pump was delivering and is now stopped and the battery

power is too low to operate the pump. If the AC adapter is
attached, select acknowledge to clear the alarm.

• Removethebatteries.

• Install4newAAbatteriesorafullychargedrechargeable

battery pack. In order to start delivery, good batteries must
always be installed, even when an external source of power is
connected.

• Ifappropriate,restartthepump.

Medium The battery power is too low to operate the pump. If the AC

adapter is attached, select acknowledge to clear the alarm.

• Removethebatteries.

• Installafullychargedrechargeablebatterypackor4new

AA batteries. In order to start delivery, good batteries must
always be installed, even when an external source of power is
connected.

but the pump is still operable. Select acknowledge to clear the
alarm or the alarm will automatically clear after 5 seconds.

• Rechargeorchangetherechargeablebatterypackorreplace

the 4 AA batteries soon.

36

References and Troubleshooting

Alarms and Messages Alarm Priority Description / Corrective Action

Battery removed. Pump
stopped.

Battery removed. Pump will
not run.

Cannot start pump with a
depleted battery.

Cannot start pump with a
reservoir volume of zero.

Cannot start pump with
rechargeable battery reached
end of use.

Cannot start pump without a
battery.

Cannot start the pump with air
in-line. Prime tubing.

High The rechargeable battery pack or the 4 AA batteries were

removed. The pump was delivering and is now stopped. Select
acknowledge to clear the alarm.

• Installafullychargedrechargeablebatterypackor4new

AA batteries. In order to start delivery, good batteries must
always be installed, even when an external source of power is
connected.

• Ifappropriate,restartthepump.

Medium The pump is stopped and the rechargeable battery pack or the

4 AA batteries were removed, but the pump is still powered by
the AC adapter. Select acknowledge to clear the alarm.

• Installafullychargedrechargeablebatterypackor4new

AA batteries. In order to start delivery, good batteries must
always be installed, even when an external source of power is
connected.

Medium The battery power is too low to operate the pump. In order

to start delivery, good batteries must always be installed
even when an external source of power is connected. Select
acknowledge to clear the alarm. Install 4 new AA batteries or a
fully charged rechargeable battery pack. If appropriate, start the
pump.

Medium The reservoir volume in the pump is set to zero. Select

acknowledge to clear the alarm. Edit the reservoir volume to
the correct value. If appropriate, start the pump.
See Patient Specific Parameters on page 29 for more information
about the reservoir volume.

Medium The rechargeable battery pack is at the end of its life. It has been

discharged and recharged so many times that it is no longer
able to hold a good charge. Remove the battery from service.
In order to start delivery, good batteries must always be
installed even when an external source of power is connected.
Select acknowledge to clear the alarm. Install 4 new AA
batteries or a new rechargeable battery pack. If appropriate,
start the pump.

Medium The pump does not have any batteries installed. In order

to start delivery, good batteries must always be installed
even when an external source of power is connected. Select
acknowledge to clear the alarm. Install 4 new AA batteries or a
rechargeable battery pack. If appropriate, start the pump.

Medium The air detector has detected air in the fluid path directly

under the air detector; the fluid path may contain air bubbles.
Select acknowledge to clear the alarm, then:

• Ifthefluidpathcontainsairbubbles,closetheclampsand

disconnect the fluid path from the patient. Then follow the
instructions for removing air by priming (see page 24 for more
information).

• Ifappropriate,startthepump.

37

References and Troubleshooting

Alarms and Messages Alarm Priority Description / Corrective Action

Cannot start pump with an
unusable battery

Cannot start pump without a
latched and locked cassette.

Cassette damaged. Remove
cassette.

Cassette detached. Pump
stopped.

Cassette locked, but not
latched. Unlock and reattach
the cassette.

Cassette not attached properly.
Reattach cassette.

Cassette unlocked. Lock
cassette.

Cassette was partially
unlatched. Fully remove and
reattach the cassette.

Check for empty tubing or
reservoir. Pump stopped.

Medium The batteries installed are either the wrong kind of AA

batteries, or you are using a rechargeable battery pack that is
not compatible with the pump. In order to start delivery, good
batteries must always be installed even when an external source
of power is connected. Select acknowledge to clear the alarm.
Remove the batteries and install the rechargeable battery pack
or 4 new AA batteries. If appropriate, start the pump.
For more information on what type of batteries to use, see
Installing the Batteries on page 14.

Medium The pump will not start without a cassette attached. Select

acknowledge to clear the alarm. Make sure a cassette is
properly attached, then start the pump.

High The pump detects the cassette is damaged. Close the tubing

clamp and inspect the cassette for damage. The pump is
stopped and will not run. Replace cassette if necessary.

NOTE: You must remove the cassette to continue.
NOTE: This alarm will also occur if a cassette is attached

during one of the following situations:

• Thepumpissettothefactorydefaultandthenpoweredoff,

then on.

• Thepumpwasloadedwithnewsoftwareandthenpowered

off, then on.

High The cassette was detached while the pump was delivering

and the pump is now stopped. Select acknowledge to clear the
alarm. Reattach the cassette and, if appropriate, restart the
pump.

High The cassette/keypad lock is locked, but there is no cassette

attached. The pump is stopped and will not run. Select
acknowledge to clear the alarm. Unlock the cassette/keypad
lock and reattach the cassette.

High The pump detects the cassette is not properly attached. Close

the tubing and remove the cassette, then reattach. If the alarm
persists, replace the cassette.
NOTE: You must remove the cassette to continue.

Medium This is a reminder that the cassette is not locked while the

pump is delivering. If this alarm is sounding, lock the cassette
to clear it.

Medium The cassette was not completely removed from the pump before

it was reattached and, therefore, the pump’s sensors are not able
to detect the cassette type. Remove the cassette and reattach it,
then verify the cassette type in the pump’s display. If this alarm
persists, replace the cassette.
NOTE: You must remove the cassette to continue.

High The tubing beneath the pump may not contain fluid, or the

fluid container may be empty. The pump is stopped and will
not run. Select acknowledge to clear the alarm. Check whether
the fluid container is empty; or clamp the tubing, remove the
cassette, and check for air in the tubing. If the alarm persists
after trying the above, it means the pump’s pressure sensor
is faulty. Remove the pump from service and contact Smiths
Medical Customer Service.

38

References and Troubleshooting

Alarms and Messages Alarm Priority Description / Corrective Action

Delivery limit reached. (Pump’s
status bar will read “KVO = 0”)

OR

Delivery limit reached and
partial dose delivered. (Pump’s
status bar will read “KVO = 0”)

Delivery limit reached.
(Pump’s status bar will read
“DelLimit”)

OR

Delivery limit reached
and partial dose delivered.
(Pump’s status bar will read
“DelLimit”)

Delivery too slow. 1 mL of uid
not delivered.

Depleted battery is charging. Low The rechargeable battery pack is depleted and is being

Downstream occlusion. Clear
occlusion between pump and
patient.

Low The programmed delivery limit has been reached, and the

pump is not delivering fluid. This alarm occurs when the
continuous rate is programmed to 0 mL/hr, and either a PCA
dose or the continuous rate has caused the delivery limit to be
exceeded. Select acknowledge to clear the alarm or the alarm
will automatically clear after 5 seconds.
NOTE: The status bar display will remain after the alarm has
cleared.

Low The programmed delivery limit has been reached, and the

pump is delivering fluid at the KVO rate of 0.1 mL/hr. This
alarm occurs when the continuous rate is programmed to
greater than 0 mL/hr, and either a PCA dose or the continuous
rate has caused the delivery limit to be exceeded. Select
acknowledge to clear the alarm or the alarm will automatically
clear after 5 seconds.
NOTE: The status bar display will remain after the alarm has
cleared.

Medium The pump is busy with too many activities and does not have

sufficient resources to support the programmed delivery rate.
The delivery has fallen behind by 1 mL. Select acknowledge
to clear the alarm. If this alarm occurs regularly, the pump
may be faulty. Remove the pump from use and contact Smiths
Medical Customer Service.

recharged with the AC adapter. Select acknowledge to clear the
alarm or the alarm will automatically clear after 5 seconds.

High The pump has detected high pressure, which may be resulting

from a downstream blockage, kink in the fluid path, or a
closed tubing clamp. Delivery is paused and will resume if
the occlusion is removed. Remove the obstruction to resume
operation. Or select Stop Pump to stop the pump and silence
the alarm for 2 minutes, then remove the obstruction and
restart the pump.

NOTE: To reduce the potential bolus delivery after an
occlusion, perform the following:

1. Select Stop Pump to stop the pump.

2. Close the distal clamp. If the distal clamp is the cause of
obstruction, keep it closed and continue with step 4.

3. Remove the obstruction.

4. Detach the medication cassette reservoir or CADD®
administration set from the pump.

5. Open the ow stop feature, if present.

6. Wait 10 seconds.

7. Close the ow stop feature, if present.

8. Reattach the medication cassette reservoir or CADD®
administration set to the pump.

9. Open the distal clamp.

10. Review the pump’s program.

11. Restart the pump.

39

References and Troubleshooting

Alarms and Messages Alarm Priority Description / Corrective Action

External power source faulty.
Change power source.

High Flow Admin Set not
allowed. Remove cassette.

Key stuck. Release key or
remove power. Pump stopped.

Lock cassette to start pump. Medium The cassette must be locked onto the pump before beginning

Loss of power occurred while
pump was running.

Motor service due. Medium The pump’s motor requires service. Select acknowledge to clear

New pump settings
downloaded. Press
‘Acknowledge’ then review.

PCA dose cord button stuck.
Release or remove cord.

PCA dose cord disconnected. Medium / Low Medium: The PCA remote dose cord was disconnected from

Preventive maintenance due. Medium Your facility may have established a maintenance program for

Protocol library updating.
Reselect protocol when update
is complete.

Medium The AC adapter’s output voltage is too high. Select acknowledge

to clear the alarm. The AC adapter is faulty, remove from
service.

High The CADD® high volume administration set cannot be used

with the PCA delivery mode. The pump is stopped and will not
run.
NOTE: You must remove the administration set to continue.

High A key may be pressed down. The pump is stopped and will not

run. Make sure there is nothing pressing on any of the keys. If
the alarm persists, close the tubing clamp, remove the batteries
to turn off the pump, and remove the pump from use. Contact
Smiths Medical Customer Service to return the pump for
service.

delivery. If this alarm is sounding, lock the cassette to clear the
alarm and the pump will automatically start.

Medium The pump lost power while it was running. This alarm will

occur when the pump restarts. Select acknowledge to clear the
alarm and, if appropriate, restart the pump.

the alarm. Remove the pump from use at the next cassette
change and contact Smiths Medical Customer Service to return
the pump for service.

Low A new protocol was just downloaded into the pump from the

CADD®-Solis Medication Safety Software. Select acknowledge
to clear the alarm. Review the protocol to ensure the correct
one has been downloaded.

High The PCA remote dose cord button may be pressed down. The

pump is stopped and will not run. Make sure there is nothing
pressing on the PCA remote dose cord button. If the alarm
persists, remove the PCA remote dose cord to clear the alarm
and contact Smiths Medical Customer Service. You may
continue using the pump with another PCA remote dose cord,

or using the

the pump while the pump is delivering. Select acknowledge to
clear the alarm or reattach the PCA remote dose cord.
Low: The PCA remote dose cord was disconnected from the
pump while the pump is stopped. Select acknowledge to clear
the alarm or the alarm will automatically clear after 5 seconds.

the pump, and the pump is due for preventive maintenance.
Select acknowledge to clear the alarm and refer to your facility’s
policy for preventive maintenance.

Medium A new or updated library is currently being downloaded into

the pump. The pump will not allow you to select any new
protocols while this update is in process. Select acknowledge to
clear the alarm or it will automatically clear when the update is
complete.

PCA dose @ button on the pump.

40

References and Troubleshooting

Alarms and Messages Alarm Priority Description / Corrective Action

Pump does not have a protocol
library.

Pump settings and patient data
lost.

Pump stopped by an alarm that
has since cleared.

Pump stopped reminder. High This is a reminder that the pump has been stopped and is not

Rechargeable battery near end
of use. Replace battery.

Rechargeable battery reached
end of use. Pump will not run.

Reservoir volume is zero. Pump
stopped.

Reservoir volume low. Medium / Low* Medium: The programmed reservoir volume trip point has

Medium If the pump had a protocol library the last time it was powered

on, but now it does not, you will see this alarm. This would
happen if the pump was manually reverted to the factory
default, has recently had a software update, or if an attempt
to install a protocol library failed. Select acknowledge to clear
the alarm and refer to your facility’s CADD®-Solis system
administrator to download a new protocol library.

Medium The pump reverted to the factory default. The pump was

either manually reverted to this default, has recently had a
software update, or it has not been in use for some time. Select
acknowledge to clear the alarm and refer to your facility’s
CADD®-Solis system administrator to reprogram the pump.

High The pump was stopped by another high priority alarm. That

alarm was not acknowledged, but the problem has since
cleared. Select acknowledge to clear the alarm and restart the
pump, if appropriate. The event log has recorded the alarm that
stopped the pump. For information on accessing the event log,
see Reports on page 27.

delivering. Select acknowledge to clear the alarm. Start the
pump, if appropriate. The alarm will repeat in 5 minutes if the
pump has not been restarted or powered down.

Medium The rechargeable battery pack is near the end of its life. It has

been discharged and recharged so many times that it will soon
be at the end of its use. You may continue to use it in this state.

High The rechargeable battery pack is at the end of its life. It has been

discharged and recharged so many times that it is no longer
able to hold a good charge. Remove the battery from service.

• Install4newAAbatteriesorafullychargedrechargeable

battery pack. In order to start delivery, good batteries must
always be installed even when an external source of power is
connected.

High The reservoir volume has reached 0.0 mL. The pump was

delivering and is now stopped and will not run. Select
acknowledge to clear the alarm. Install a new f luid container
and edit the value of the reservoir volume, if appropriate.

been reached indicating the level of fluid in the reservoir is low.
Select acknowledge to clear the alarm.
Low: The reservoir volume value is low, indicating that the level
of fluid in the fluid container is low. Select acknowledge to clear
the alarm or the alarm will automatically clear after 5 seconds.

Prepare to install a new fluid container and edit the value of the
reservoir volume, if appropriate.

* The low reservoir alarm can be set to one of two alarm types: “Insistent and One Time Only” alarm (Medium) or “Non-Insistent and
Repeating” (Low). The “Insistent and One Time Only” alarm will not reoccur once it has been acknowledged. The “Non-Insistent and
Repeating” alarm will repeat at the 75%, 50%, and 25% marks of the Reservoir Low Trip Point.

41

References and Troubleshooting

Alarms and Messages Alarm Priority Description / Corrective Action

Unknown cassette type.
Remove cassette.

Unusable battery. Pump
stopped

Unusable battery. Pump will
not run.

Upstream occlusion. Clear
occlusion between pump and
reservoir.

High The pump detects the cassette is incompatible with the pump.

The pump is stopped and will not run. Close the tubing clamp,
remove and then reattach the cassette. If the alarm persists,
replace the cassette.
NOTE: You must remove the cassette to continue.

High The batteries installed are either the wrong kind of AA

batteries, or you are using a rechargeable battery pack that is
not compatible with the pump. The pump was delivering and
is now stopped and will not run. Select acknowledge to clear
the alarm. Remove the batteries and install a fully charged
rechargeable battery pack or 4 new AA batteries. For more
information on what type of batteries to use, see Installing the
Batteries on page 14.

Medium The batteries installed are either the wrong kind of AA

batteries, or you are using a rechargeable battery pack that is
not compatible with the pump. Select acknowledge to clear
the alarm. Remove the batteries and install a fully charged
rechargeable battery pack or 4 new AA batteries. For more
information on what type of batteries to use, see Installing the
Batteries on page 14.

High Fluid is not flowing from the fluid container to the pump,

which may be resulting from a kink, a closed clamp, or air
bubble in the tubing between the f luid container and pump.
Delivery is paused and will resume if the occlusion is removed.
Remove the obstruction to resume operation. The alarm will
clear when the occlusion is removed. You will be required to
acknowledge this alarm after it clears if it has occurred and
cleared more than 3 times within 15 minutes.

42

References and Troubleshooting

Cleaning the Pump and Accessories

Cleaning Solutions

The following solutions may be used to clean the
pump and accessories, unless otherwise specified:

NOTE: Refer to the instructions for use for each
accessory before proceeding with cleaning.

• Soapsolution

• Benzalkoniumchlorideconcentrate(0.13%)

• Glutaralconcentrate,USP(2%)

• 10%solutionofhouseholdbleach(onepart

household bleach to nine parts water)

• Alcohol,USP(93%)

• Isopropylalcohol,USP(99%)

• Chlorhexidinegluconate(4%)

• PDISuperSani-Cloth

• Madacide,MADAMedical

• VirexIImadebyJohnsonWax

• CoverageSprayandCoverageHBPlusby

Steris

• CaviCide® by Metrex

• QuikFillCompac(A-456-N)byAirkem

CAUTION:

• Do not immerse the pump in cleaning fluid

or water. Do not allow solution to soak in
to the pump, accumulate on the keypad, or
enter the battery compartment, USB port,
remote dose cord jack, or power jack areas.
Moisture buildup inside the pump may
damage the pump.

• Do not clean the pump with acetone, other

plasticsolvents,orabrasivecleaners,as

damage to the pump may occur.

1. Dampen a soft, lint-free cloth with cleaning
solution. Apply the solution to the exterior
surface of the pump or accessory (per
manufacturer’s instructions). Do not allow the

solution to soak into the pump or accessory.

®

NOTE: Ensure that debris is not allowed to build
up on the pressure plate surface of the pumping
mechanism (see the Technical Manual for a
diagram of the pumping mechanism). Inspect
the air detector sensor slot and remove any
debris.

2. Allow the pump to dry completely before use.

Exposure to Radiation or Magnetic
Resonance Imaging (MRI)

CAUTION:

• ThepumpSHOULDNOTBEDIRECTLY

IRRADIATEDbytherapeuticlevelsof

ionizing radiation because of the risk of
permanent damage to the pump’s electronic

circuitry.Thebestproceduretofollowisto
removethepumpfromthepatientduring

therapeutic radiation sessions or diagnostic

levelsofradiographicandfluoroscopic

radiation. If the pump must remain in the

vicinityduringadiagnosticor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.

• Magnetic fields produced by magnetic

resonance imaging (MRI) equipment 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.

• Use of this pump on patients monitored by

electronic equipment may cause artifactual
interference. As with all electronic
equipment, electrical artifacts which affect
the performance of other equipment, such as

ECGmonitors,canoccur.Theusershould

check the correct function of the equipment
prior to use.

• Do not use the pump in hyperbaric

chambers as they will affect how the pump
works and may also cause damage to the
pump.

43

References and Troubleshooting

Continuous Rate Scroll Ranges PCA Dose, Clinician Bolus Scroll

Ranges: Milligrams

Units Starting Increment Maximum
Value

Milliliters 0 0.10 30.00

Milligrams 10% of mg only: Values between 0.01 and 0.5: 0.01 Concentration
& Micrograms concentration mcg only: Values between 0.1 and 0.5: 0.1 x 30
Values between 0.5 and 100: 0.1
Values between 100 and 1000: 1.0
Values greater than 1000: 10.0

PCA Dose, Clinician Bolus Scroll
Ranges: Milliliters

Milliliters

increment max

0.05 20

Concent ration

mg/mL

0.1 0.01 2

0.2 0.02 4

0.3 0.03 6

0.4 0.04 8

0.5 0.05 10
1 0.05 20
2 0.10 40
3 0.15 60
4 0.20 80
5 0.25 100
6 0.30 120
7 0.35 140
8 0.40 160
9 0.45 180
10 0.50 200
11 0.55 220
12 0.60 240
13 0.65 260
14 0.70 280
15 0.75 300

Millig rams

increm ent max

Concent ration

mg/mL

20 1.00 400
25 1.25 500
30 1.50 600
35 1.75 700
40 2.00 800
45 2.25 900
50 2.50 1000
55 2.75 1100
60 3.00 1200
65 3.25 1300
70 3.50 1400
75 3.75 1500
80 4.00 1600
85 4.25 1700
90 4.50 1800
95 4.75 1900
100 5.00 2000

Millig rams

increm ent max

PCA Dose, Clinician Bolus Scroll
Ranges: Micrograms

Concent ration

mcg/mL

1 0.05 20
2 0.10 40
3 0.15 60
4 0.20 80
5 0.25 100
6 0.30 120
7 0.35 140
8 0.40 160
9 0.45 180
10 0.50 200
11 0.55 220
12 0.60 240
13 0.65 260
14 0.70 280
15 0.75 300
20 1.00 400
25 1.25 500
30 1.50 600
35 1.75 700
40 2.00 800

Microg rams

increm ent max

Concent ration

mcg/mL

45 2.25 900
50 2.50 1000
55 2.75 1100
60 3.00 1200
65 3.25 1300
70 3.50 1400
75 3.75 1500
80 4.00 1600
85 4.25 1700
90 4.50 1800
95 4.75 1900
100 5.00 2000
200 10.00 4000
300 15.00 6000
400 20.00 8000
500 25.00 10000

Microg rams

increm ent max

44

References and Troubleshooting

Technical Description

Standardsusedindevelopmentofthepump

The following standards were used in whole or part
in the development of the pump.

MedicalElectricalEquipment

 EN60601-1(1990), Medical Electrical

Equipment, Part I: General Requirements for
Safety. Amendment A1 (1993) Amendment
A13 (1996) Amendment A2 (1995).

 EN60601-2-24(1998), Medical Electrical

Equipment, Part 2-24: particular Requirements
for Safety of Infusion Pumps and Controllers.

 EN60601-1-4(1996), Medical Electrical

Equipment, Part 1-4: General Requirements
for Safety - Collateral Standard: Programmable
electrical medical systems. Amendment A1:

1999.

 IEC60601-1(2ndEdition,1988), Medical

Electrical Equipment, Part 1: General
Requirements for Safety. Amendment 1 (1991)
Amendment 2 (1995).

 IEC60601-1-4(2000), Medical Electrical

Equipment, Part 104: General Requirements
for Safety - Collateral Standard: Programmable
electrical medial systems.

 IEC60601-2-24(1998), Medical Electrical

Equipment, Part 2-24: Particular Requirements
for Safety of Infusion Pumps and Controllers.

 IEC60601-1-2(Edition2.1,2004-11),

Medical Electrical Equipment, Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility ­Requirements and Tests.

 IEC61000-4-2(2001), Electromagnetic

Compatibility (EMC), Part 4-2: Testing
and measurement techniques. Electrostatic
Discharge immunity test.

 IEC61000-4-3(2006), Electromagnetic

Compatibility (EMC), Part 4-3: Testing and
measurement techniques. Radiated, radio
frequency, electromagnetic field immunity
test.

 IEC61000-4-4(2004), Electromagnetic

Compatibility (EMC), Part 4-4: Testing and
measurement techniques. Electrical fast
transient/burst immunity test.

 IEC61000-4-5(2005), Electromagnetic

Compatibility (EMC), Part 4-5: Testing and
measurement techniques. Surge immunity test.

 IEC61000-4-6(2004), Electromagnetic

Compatibility (EMC), Part 4-6: Testing
and measurement techniques. Immunity to
conducted disturbances, induced by radio­frequency fields.

 IEC61000-4-8(2001), Electromagnetic

Compatibility (EMC), Part 4-8: Testing and
measurement techniques. Power frequency
magnetic field immunity test.

 CAN/CSA-C22.2601.1-M90,Medical

Electrical Equipment, Part 1: General
Requirements for Safety - November 1990
(Canadian Deviations to IEC 60601-1) Update
No. 2 (November 2003).

ElectromagneticCompatibility

 RTCA/DO-160E(2004),Radiated Emissions

Only, Category M Limit.

 EN60601-1-2(2001), Medical Electrical

Equipment, Part 1-2: General Requirements
for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements
and Tests.

 IEC61000-4-11(2004), Electromagnetic

Compatibility (EMC), Part 4-11: Testing and
measurement techniques. Voltage dips, short
interruptions and voltage variations immunity
test.

 CISPR11(2004), Limits and methods of

measurement of electromagnetic disturbance
characteristics of industrial, scientific and
medical (ISM) radio frequency equipment.
Amendment 1 (1999) Amendment 2 (2002).

 EN45502-1(1998),Active implantable

medical devices. Part 1. General requirements
for safety, marking and information to be
provided by the manufacturer.

45

References and Troubleshooting

 EN55011(1998), Industrial, scientific and

medical (ISM) radio frequency equipment

- Radio disturbance characteristics - Limits
and methods of measurement. Amendment 1
(1999), Amendment 2 (2002)

Miscellaneous Standards

 USB1.1Universal Serial Bus (USB)

Specification, Revision 1.1, September 23,
1998 – USB.org

EN1041(1998), Information supplied by the

manufacturer with medical devices.

 IEC/TR60878(2003), Graphical symbols for

electrical equipment in medical practice.

 EN980(2003), Graphical symbols for use in

the labeling of medical devices.

 IEC60529(2001), Degrees of protection

provided by enclosures (IP Code).

Specifications (Nominal)

General Pump Specications

Medication cassette reservoir, part number 21-7002,
CADD® extension sets, part number 21-7045, and
CADD® administration sets, part number 21-7091
were used to test the pump.

Resolution

Medication cassette reservoir or CADD
administration set, 0.050 mL per pump stroke
nominal.

®

Disposable type invalid; Disposable locked but
not latched; Reservoir volume empty; Pressure
sensor faulty; Downstream occlusion; Upstream
occlusion; Air in line detected; Remote dose
cord key stuck; Key stuck; Stop mode reminder;
Pump was automatically stopped.

There are an additional 19 medium

priority alarms, 8 low priority alarms, and
20informational messages alerts.

Battery Fallout Alarm

Alarm sounds for 2 minutes if the pump has
been powered up for a minimum of 2 minutes.
NOTE: Only enabled while pump is in run
mode.

Battery Status

Battery State CADD® Pump Status

25%—100% No alarm

Low battery Transition to low battery

condition; battery low message
appears; 3 beeps every 5min.†
LCD backlight will ash for 12ms
during each motor operation.

Depleted
battery

Shut down Pump shuts o due to too low

CADD®-Solis pump low battery conditions.

†

The pump emits 3 beeps every 5 minutes, and the low battery warning

message appears on the pump’s display, indicating that the battery

power is low, but the pump is operable.

Transition to depleted battery
condition; battery depleted
message appears; pump beeps
continuously.

operating voltage.

††

Size

4.1 cm × 10.2 cm × 12.7 cm [1.6 in. × 4 in. ×

5in.] excluding cassette or other accessories.

Weight

595 g [21 oz.] including 4 AA alkaline batteries,
excluding other accessories.

Pump Alarms

The following alarms are all considered to be
high priority alarms: Battery depleted while
delivering; Battery removed while delivering;
Battery unusable while delivering; Rechargeable
battery end of life; Disposable detached while
delivering; Disposable attached improperly;
Disposable type high flow administration set;

46

††

The pump emits a continuous, variable-tone alarm, and the depleted

battery warning message appears on the display, the battery power is

too low to operate the pump, and the pump delivery operation has

stopped.

ContinuousDeliveryAlkalineBatteryLife

withscreenintensitysetto3

Rate Life Volume

0.4 mL/hr 260 hrs 104 mL

1 mL/hr 210 hrs 210 mL

5 mL/hr 165 hrs 825 mL

10 mL/hr 150 hrs 1500 mL

30 mL/hr 70 hrs 2100 mL

References and Troubleshooting

ContinuousDeliveryRechargeableBatteryPack

Lifewithscreenintensitysetto3

Rate Life Volume

0.4 mL/hr 119 hrs 47.6 mL

1 mL/hr 89 hrs 89 mL

5 mL/hr 88 hrs 440 mL

10 mL/hr 86 hrs 860 mL

30 mL/hr 43 hrs 1290 mL

Classification

CF , Class II

Moisture Protection

Splashproof (

Maximum Infusion Pressure

27.0 psi [1.86 bar].

MaximumTimetoOcclusionAlarm

0.1 mL/hr - medication cassette reservoir:
108minutes. CADD® administration set:
122minutes.
10 mL/hr - medication cassette reservoir:
44seconds. CADD® administration set:
122seconds.

NOTE: Values are nominal and based on

actual test data.

.



) per IEC 60529.

SystemOperatingTemperature

2°C to 40°C (36°F to 104°F).

SystemStorageandTransportationTemperature

–20°C to 60°C (–4°F to 140°F).

RelativeHumidity

20% to 90% relative humidity, non-condensing.

Atmospheric Pressure

70 kPa (10.2 psi) to 106 kPa (15.4 psi).

SystemDeliveryAccuracy

± 6% (nominal). At low infusion rates, this
accuracy may not be achieved for short periods.
During the total infusion time, the accuracy
averages out.

WARNING:

• Ensurethatthe±6%systemdeliveryaccuracy

specication is taken into account when
programming the pump and/or lling the

reservoir.Failuretodosomayresultin
medicationinthereservoirbecomingdepleted

sooner than expected. If the pump is being used

todelivercriticalorlifesustainingmedication,
theinterruptioninthedeliveryofmedication

could result in patient injury or death.

Bolus Volume at Occlusion Alarm

0.1 mL/hr - medication cassette reservoir:

0.107mL. CADD® administration Set: 0.136 mL.
10 mL/hr - medication cassette reservoir:

0.116mL. CADD® administration set: 0.124 mL.

NOTE: Values are nominal and based on

actual test data.

Power Sources

Four AA (IEC LR6) alkaline batteries; AC
adapter; rechargeable battery pack.

Charging System for Internal Memory Backup
Battery

The internal memory backup battery utilizes
lithium manganese dioxide technology. It
charges whenever the pump is powered on and
has a 10month memory capacity once it has
been charged for 250 hours at 20°C (68°F).

• Systemdeliveryinaccuraciesmayoccuras

a result of back pressure or uid resistance,

whichdependsupondrugviscosity,catheter

size, and extension set tubing (for example,
microbore tubing), and placing the infusion

reservoirand/orpumpaboveorbelowthelevel
ofthepatient.Systemdeliveryinaccuracymay
resultinunderorover-deliveryofmedication,

which could result in death or serious injury to
the patient.

System Definition

CADD

-Solis pump with:

®

• An attached medication cassette reservoir

and CADD® extension set or

• an attached CADD

CADD®-Solis pump with:

administration set or

®

• an attached medication cassette reservoir

with flow stop feature and CADD® extension
set or

• A CADD

feature.

administration set with flow stop

®

47

References and Troubleshooting

HighPressureAlarmThreshold

18 ± 9 psi [1.24 ± 0.62 bar].

Air Detector Alarm

Sensitivity:
Low - Single bubble greater than 400 μL .
High - Single bubble greater than 150 μL .
Accumulated Air: Greater than 1 mL air over
15minutes (nominal).

BolusAccuracySpecification ±6%

Actual Test Data for Bolus Accuracy at 0.05 mL:

Average 0.0508 mL
% Error 1.6%
Minimum Error % –3.0%
Maximum Error % 4.2%

Actual Test Data for Bolus Accuracy at 20 mL:

Average 20.108 mL
% Error 0.5%
Minimum Error % –2.9%
Maximum Error % 4.5%

Maximum Volume Infused Under Single-Fault
Conditions

CADD

administration set: 0.15 mL.

®

Concentration

mg/mL:

0.1 to 0.5 mg/mL in increments of 0.1 mg/mL.

0.5 to 1 mg/mL in increments of 0.5 mg/mL.
1 to 15 mg/mL in increments of 1 mg/mL.
15 to 100 mg/mL in increments of 5 mg/mL.

mcg/mL:

1 to 15 mcg/mL in increments of 1 mcg/mL.
15 to 100 mcg/mL in increments of 5 mcg/mL.
00 to 500 mcg/mL in increments of 100mcg/mL.

Continuous Rate

0 to 30 mL/hr (or the mg or mcg equivalent).

PCA Dose

0 mL to 20 mL (or the mg or mcg equivalent).
Delivery rate (continuous rate + PCA dose):
programmable from 40 to 175 mL/hr.

PCA Dose Lockout

1 minute to 24 hours in the following
increments:
1 minute for values between 1 and 20 minutes.
5 minutes between 20 minutes and 24 hours.

Max Doses per Hour

1 to 60.

DeliveryRateduringpriming

Approx. 250 mL/hr.

Alarm disabled during priming

Air-In Line.

Delivery Specications

ReservoirVolume

0 to 9999; programmable in 1 mL increments,
displayed in 0.1 mL increments.

Programming Units

Milliliters (mL), milligrams (mg), micrograms
(mcg).*

*If programming through the manual mode.
Otherwise the programming units are preset
through the CADD
Software.

-Solis Medication Safety

®

DeliveryLimitAmount

0.1 to 1000 mL (or the mg or mcg equivalent)
in increments of:

0.01 mL from 0.01 to 0.5 mL.

0.5 mL from 0.5 to 100 mL.

1.0 mL from 100 to 1,000 mL.

Given

0 to 99,999.99 in 0.01 unit increments.

Clinician Bolus

0 mL to 20 mL (or mg or mcg equivalent)
delivery rate (continuous rate + clinician bolus):
programmable from 40 to 175 mL/hr.

Administrator Settings Specications

DeliveryLimitMethod

Delivery limit, max doses per hour, or not in
use.

DeliveryLimitPeriod

1 to 12 hours in increments of 1 hour.

48

References and Troubleshooting

MaximumDeliveryRate(combinedbolusand

continuous)

40 to 175 mL/hr in increments of 1 mL.

Key Beeps

On or off.

ResVolLowTripPoint

1 to 999 mL in increments of 1 mL.

ResVolEmptyAlarm

Insistent and one time only or non-insistent
and repeating.

Pump Stopped Alarm

Informational or high priority.

Air Detector

Turned on or turned off.

AirDetectorSensitivity

Low Sensitivity - Single bubble greater than
400μL .
High Sensitivity - Single bubble greater than
150μL .

Alarm Volume

High, medium, or low.

PM(PreventativeMaintenance)Reminder

Interval: 1 to 24 months in 1 month increments.
Enable: On or off.

the pressure to settle before a possible alarm
(if the pressure settles below the high pressure
alarm threshold before the 2 second delay is
complete, the alarm will not happen).

Upstream Occlusion Sensor

On or off.
NOTE: The upstream occlusion sensor
is automatically disabled during use with
medication cassette reservoirs.

Electromagnetic Emissions and Immunity
Declarations

Guidance and manufac turer’s declaration - electromagnetic emissions

The CADD®-Solis pump is intended for use in the electromagnetic environment sp ecified
below. The customer or the user of the CADD®-Solis pump should assure that i t is used in such
an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Voltage fluc tuations/
flicker emissions
IEC 61000-3-3

Compliance using:

Group 1 The Pump uses RF energy only for its inter nal

Class B The Pump is suitable for use in all establishments,

Not applicable

Not applicable

function. Therefore, it s RF emissions are very low
and are not likely to cause any inter ference in
nearby elect ronic equipment.

including domes tic establishments and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.

Custom Keypad Code

001 to 899 in increments of 1.

Custom Clinician Code

001 to 899 in increments of 1.

Custom Administrator Code

001 to 899 in increments of 1.

Date Format

US standard (mm/dd/yy) or European standard
(dd/mm/yy).

Time

00:00 to 23:59.

DownstreamOcclusionSensitivity

High Sensitivity - once the high pressure alarm
threshold is reached, the downstream occlusion
alarm is triggered immediately.
Low Sensitivity - once the high pressure alarm
threshold is reached, the downstream occlusion
alarm is delayed for 2 seconds, this allows for

1. 100-240 VAC 50/60Hz to 7VDC switching
desktop AC adapter, with an AC power cord
length of 1.8 m (6 feet).

2. Rechargeable battery pack.

3. Remote dose cord with a length of 152 cm ± 5
cm (60 in. ± 2 in.).

4. USB cable length of less than 2 m (6.5 feet).

WARNING:

• e use of power supplies and a remote

dose cord other than those listed in the
electromagnetic emissions declaration may
result in increased emissions or decreased
immunity of the pump.

• e pump should not be used adjacent to or

stacked with other equipment. If adjacent
or stacked use is necessary, the user should

verifynormaloperationofthepumpinthe

conguration in which it is to be used.

49

References and Troubleshooting

Guidance and manufac turer’s declaration - electromagnetic immuni ty

The CADD®-Solis pump is intended for use in the electromagnetic environment sp ecified
below. The customer or user of the CADD®-Solis pump should assure that it is u sed in such an
environment.

Immunit y
Test

Electro static
discharge (ESD)
IEC 61000-4-2

IEC 60601
test level

± 6 kV contact

± 8 kV air

Compliance
level

± 8 kV contact

± 15 kV air

(IEC 60601-

Electr omagnetic environment ­guidance

Floors should b e wood, concrete,
or ceramic tile. If f loors are covered
with synthetic material, the relative
humidity should be at least 30%.

2-24)

Electr ical fast
transient/burst
IEC 61000-4- 4

± 2 kV for
power supply
lines

± 1 kV for

± 2 kV for
power supply
lines

Not applicable

Mains power qualit y should be that
of a typical commercial or hospital
environment.

input/output
lines

Surge
IEC 61000-4-5

Voltage
dips, short
interruptions,
and voltage
variations on
power supply
input lines
IEC 61000-4-11

Power
frequenc y
50/60 Hz)
magnetic field

± 1 kV line(s)
to line(s)

± 2 kV line(s)
to earth

<5 % Ut (>95
% dip in Ut)
for 0.5 cycle

40 % Ut (60 %
dip in Ut) for 5
cycles

70 % Ut (30 %
dip in Ut) for
25 cycles

<5 % Ut (>95
% dip in Ut)
for 5 sec

± 1 kV line(s)
to line(s)

± 2 kV line(s)
to earth

<5 % Ut (>95
% dip in Ut)
for 0.5 cycle

40 % Ut (60 %
dip in Ut) for 5
cycles

70 % Ut (30 %
dip in Ut) for
25 cycles

<5 % Ut (>95
% dip in Ut)
for 5 sec

3 A/m 400 A/m

(IEC 60601­2-24)

Mains power qualit y should be that
of a typical commercial or hospital
environment.

Mains power qualit y should be that
of a typical commercial or hospital
environment. If the user of the
Pump requires continued operatio n
during power mains inter ruptions,
it is recommende d that the Pump
be powered from an uninterruptible
power supply or a bat tery.

Power frequenc y magnetic fields
should be at levels characterist ic
of a typical lo cation in a typical
commercial or hospit al environment.

IEC 61000-4- 8

NOTE Ut is the a.c. mains voltage prior to application of the te st level.

Guidance and manufac turer’s declaration - electromagnetic immuni ty

The CADD®-Solis pump is intended for use in the electromagnetic environment sp ecified
below. The customer or user of the CADD®-Solis pump should assure that it is u sed in such an
environment.

Immunit y
Test

IEC 60601
test level

Compliance
level

Electr omagnetic environment ­guidance

Portable and mobile RF
communications equipment should
be used no clos er to any part of the
Pump, including cables, t han the
recommended separation distance
calculated from the equation
applicable to the f requency of the
transmitter.

Conducted RF
IEC 61000-4- 6

Conducted RF
IEC 61000-4- 6

Radiated RF IEC
61000-4-3

3 Vrms
150 kHz to 80
MHz outside
ISM bands

10 Vrms
150 kHz to 80
MHz in ISM

b

bands

10 V/m
80 MHz to 2.5
GHz

3 Vrms Recommended separation dis tance

d=1.2

a

10Vrms Recommended separation dis tance

d=1.2

10 V/m

d=1.2
d=2.3

80 MHz to 800 MHz

800MHz to 2.5 GH z

Where P is the maximum output
power rating of the t ransmitter
in watts ( W) according to the
transmitter manufact urer and d is the
recommended separation distance in

b

meters (m).

Field strengths from fi xed RF
transmitters, as determined by an
electromagnetic site sur vey,c should
be less than the compliance level in
each frequency range.

d

Interference may occur in the vicinit y
of equipment marked with the
following symb ol:

R

NOTE 1 At 80 MHz and 800 MHz, the higher fre quency range applies.

NOTE 2 These guidelines may not apply in all situat ions. Electromagnetic p ropagation is

affected by absor ption and reflection from structure s, objects, and people

a

The ISM (industrial, scientific, and medical) bands b etween 150 kHz and 80 MHz are 6.765

MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to

40.70 MHz.

b

The compliance levels in the ISM f requency bands bet ween 150 kHz and 80 MHz and in
the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/
portable communications equipment could cause interference if it is inadvertently brought
into patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmi tters in these frequ ency ranges.

c

Field strengths from fi xed transmitters, such as b ase stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast c annot be predicted theoretically with accuracy. To assess the elec tromagnetic
environment due to fi xed RF transmitters, an electromagnetic site survey should be
considered. If the measured field s trength in the location in which the CADD®-Solis pump
is used excee ds the applicable RF compliance level above, the C ADD®-S olis pump should
be observed to verif y normal operation. If abnormal p erformance is observed, additional
measures may be nece ssary, such as reorienting or relo cating the CADD®-Solis pump.

d

Over the fre quency range 150 kHz to 80 MHz, field s trengths should be less than 3 V/m.

50

References and Troubleshooting

Recommended separation distances bet ween portable and mobile RF
communic ations equipment and the CADD®-Solis pump

The CADD®-Solis pump is intended for use in an ele ctromagnetic environment in which
radiated RF disturbances are cont rolled. The customer or the user of the CADD®-Solis pump
can help prevent elec tromagnetic interference by maintaining a minimum distance betwe en
portable and mobile RF communications equipment (transmitters) and the CADD®-Solis pump
as recommended b elow, according to the maximum out put power of the communic ations
equipment.

Rated

maxim um

outpu t power

or trans mitter

W

0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.73

1 1.2 1.2 1.2 2.3

10 3.8 3.8 3.8 7.3

100 12 12 12 23

For transmit ters rated at a maximum outpu t power not listed above, the recommende d
separation dis tance d in meters (m) can be determined using the equation applicable to the
frequenc y of the transmitter, where P is the maximum output power r ating of the transmitter
in watts ( W) according to the transmitter manu facturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for t he higher frequency range
applies.

NOTE 2 The ISM (industr ial, scientific, and medical) bands between 150 kHz and 80 MHz are

6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.

NOTE 3 An additional f actor of 10/3 is used in calculating the recommended separation
distance for transmitter s in the ISM frequency bands b etween 150 kHz and 80 MHz and
in the frequency range 80MHz to 2.5 GHz to decrease the likelihood that m obile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas.

NOTE 4 These guidelines may not apply in all situat ions. Electromagnetic p ropagation is
affected by absor ption and reflection from structure s, objects, and people.

Separation distance according to frequency of transmit ter

m

150 kHz to 80

MHz outsi de ISM

bands

d=1.2

80 MHz to 800

MHz in ISM

bands

d=1.2

80 MHz to 800

MHz

d=1.2

800 MHz to

2.5 GHz

d=2.3

extensionsets.Disposeofusedbatteries,reservoirs,

extension sets, and other used accessories, or a
pump that has reached the end of its useful life, in

anenvironmentallysafemanner,andaccordingto

any regulations that may apply.

Programming Screens/Menus Maps

Patient Spec ific Parameters

and/or Home Sc reen

Continuous Rate*

PCA Dose*

PCA Lockout *

Hourly Limit*

Max Doses / Hour*

Reservoir Vol.

*If configured in the administrator settings to appear.

Tasks

Give Clinician Bolus

Start New Patient

Start New Proto col, Same Patient

Prime Tubing

Set Time and Date

Adjust Background Intensity

Adjust Alarm Volume

View Repor ts

Adjust Admin Set tings

Collect Separately

Z

This product contains electrical and electronic
components (including batteries) that may contain
materials, which if disposed of with general waste,
could be damaging to the environment.

In accordance with Directive 2002/96/EC Waste
Electrical and Electronic Equipment, residents of
the European Union must follow specific disposal or
recycling instructions for this product. Contact your
local distributor, or visit the following web site for
specific instructions:
http://www.smiths-medical.com/recycle/index.html

Non-European Union residents must dispose of or
recycle this product (including batteries) in accordance
with the local laws or regulations that apply.

WARNING: ere are potential health hazards

associated with improper disposal of batteries,

electronics,andcontaminated(used)reservoirsand

Report s

Given and PCA Dose Counters

PCA Dose Graph

Delivery His tory and Pie Chart

Delivery Log

Event Log

Protocol Librar y Summary

Device Information

Administrator Set tings

Delivery

Alarms

Securit y

Set Time and Date

Display and Sound

Default to Factor y Settings

NOTE: See the Administrator Settings Guide
for detailed information on navigating the
administrator settings menu.

51

References and Troubleshooting

Default Factory Settings

The first time you use the pump, the protocol will
be set to the factory default. If you desire to reset the
pump to the factory default, you may do so at any
time (refer to the Administrator Settings Guide for
more information on how to reset the pump to the
factory default).

The following chart details the factory default
parameters:

Programming Units mL
Continuous Rate 0 mL/hr
PCA Dose Amount 0 mL
PCA Dose Lockout

Period
Delivery Limit Method Not in Use
Reservoir Volume 1 mL
Reservoir Volume Reset

Value
Reservoir Volume Low

trip point
Reservoir Volume Low

Alert Type
Repeat Reservoir Volume

Empty Alert Type
Clinician Bolus Amount 0 mL
Maximum Fluid Delivery

Rate (combined bolus
and continuous)

Pump Stopped Alert Type Informational
Upstream Sensor On
Downstream Occlusion

Sensitivity
Air Detector Enabled Yes
Air Detector Sensitivity Low
Date Format mm/dd/yy
Preventative

Maintenance Reminder
Sound Volume High
Unlock Security Code ** Text Omitted **
Clinician Security Code ** Text Omitted **
Administrator Security

Code

Keypad Security Code only
Backlight Intensity 3
Color Theme Black
Sound Theme Standard
Key Beeps Enabled Yes
Manual Mode

Programming Code

1 hour

100 mL

5.0 mL

Insistent and One Time
Only

One Time Only

175 mL/hr

Low

Off

See your CADD
system administrator
for default security
codes

Administrator Code

®

-Solis

52

T (min)

(ml/hr)

Accuracy Test Results

References and Troubleshooting

In this device, as with all infusion pumps, the
motion of the pumping mechanism and variations
in individual disposables cause short-term
fluctuations in rate accuracy. The following curves
show typical performance of the pump system in
two ways:

1. A flow versus time graph during the
stabilization period (start-up curves).

2. The accuracy of fluid delivery of particular
time periods or ‘observation windows’ is
measured (trumpet curves).

The start-up curve displays flow rate continuously
from the start of the infusion. The curve visually
represents flow rate uniformity. Trumpet curves
are derived from the sixth hour of this data. Tests
performed per IEC60601-2-24 standard.

Over long observation windows, short term
fluctuations have minimal effect on accuracy
as represented by the flat part of the curve. As
the observation window is reduced, short term
fluctuations have an increasing effect as represented
by the “mouth” of the trumpet. Being aware of
system accuracy over various observation windows
may be of interest when certain drugs are being
administered. Short term fluctuations in rate
accuracy may have clinical impact depending on
the half-life of the drug being infused, both the
trumpet curve and drug half-life should be taken
into consideration.

Start-up curve over the stabilization period
Flow rate: Intermediate (10 mL/hr)

12

10

8

Flow

6

4

2

0

0 30 60 90 120 150 180 210 240 270 300

Trumpet Curve over T(2) Period:
Intermediate rate (10 mL/hr)

2.25

2.00

1.75

1.50

1.25

1.00

0.75

0.50

0.25

Percentage error of ow

0.00

Ep

max

Ep

min

2 50 11 19 31

Observation Interval

T (min)

53

References and Troubleshooting

54

Index

A

AC Adapter, 12, 14, 15, 16, 36, 40, 49
AC Power Jack, 11
AC Power Light, 11
Administration,

analgesics, 7
anesthetics, 7
epidural, 7

subarachnoid, 7
Administrator Code, 21, 49, 52
Administrator Settings, 22, 27, 51
Admin Settings, 22, 27, 51
Air Detector, 33
Alarms, 35

Alarms and Messages, Alphabetical List, 36

High Priority Alarm, 35

Low Priority Alarm, 35

Medium Priority Alarm, 35

System Fault Alarm, 35
Alarm Volume, 21, 22, 26
Analgesics, 7
Anesthetics, 7
Autolock, 22

Index

Current Date, 25
Current Time, 25
Curve,

Start-up, 53
Trumpet, 53

D

Date Format, 26
Default Factory Settings, 51, 52
Delivery History and Pie Chart, 28
Delivery Limit, 22, 28, 31, 33, 39, 48

Delivery Limit Amount, 33
Delivery Limit Method, 48, 52

Delivery Limit Period, 33, 48
Delivery Log, 28
Delivery Methods, 13

Clinician Bolus, 13

Continuous Rate, 13

PCA Dose, 13
Device Information, 1, 29, 51
Display, 11, 51

B

Backlighting, 11, 15
Backlight Intensity, 21, 22, 26
Battery, 14, 37, 38, 42

Battery Depleted, 36, 37, 39
Battery Low, 36
Battery Removed, 37
Installing the Batteries, 14
Rechargeable Battery Pack, 15, 37, 41, 49

Battery Compartment, 11, 12

C

CADD-Solis Medication Safety Soware System, 15, 27
Cassette, 11, 16, 38, 40, 42

Attach a Cassette, 18

Remove a Cassette, 19
Cassette/Keypad Lock, 11, 12, 21, 22, 29, 38
Cassette Latch, 11, 12, 29
CAUTIONS, 3
Clinician Bolus, 20, 21, 22, 27, 28, 31, 33, 48, 51, 52
Clinician Code, 21
Continuous Rate, 21, 27, 28, 30, 31, 33, 39, 48, 51, 52
Counters, 22, 27, 30, 51

Given, 27

PCA Dose, 27

E

Emissions Declarations, 49
Epidural Administration, 7
Event Log, 23, 24, 25, 28, 51

F

Factory Settings, 51, 52
Features of the pump system, 9

G

Given counter, 27

PCA Doses Attempted, 27
PCA Doses Given, 27
Total Given, 27

H

Hard Limit, 29

maximum, 29

minimum, 29
High Priority Alarm, 35
Home Screen, 17, 29

Patient Specic Parameters 29

Programming Screens, 29
Hourly Limit, 31, 51

55

Index

I

Immunity Declarations, 49
Indicator Lights, 11, 15
Informational Message, 35
Installing the Batteries, 14

K

Keypad, 11, 12, 22, 29
Keypad Code, 21

L

Lock, 11
Log, 28

Delivery, 28
Event, 28

Low Priority Alarm, 35

M

Magnetic Resonance Imaging, 43
Manual Mode, 32, 52
Max Doses/Hr, 21, 31
Maximum Delivery Rate, 33, 49
Medium Priority Alarm, 35
Menus Maps, 51
Messages, 11, 17, 35

Alarms and Messages, Alphabetical List, 36
Informational Message, 35

MRI, 43

N

New Patient, 22, 23, 28, 51
New Protocol, 21, 24, 28, 40, 51

P

Patient Specic Parameters, 17, 28, 29, 51

Continuous Rate, 30
Hourly Limit, 31
Max Doses/Hr, 31
PCA Dose, 30
PCA Lockout, 30

Reservoir Volume, 32
PCA Delivery, 40
PCA Dose, 12, 13, 16, 20, 21, 22, 27, 28, 30, 31, 33, 39, 40, 48,

51
PCA Dose counter, 27
PCA Dose Graph, 28
PCA Lockout, 30, 31, 48, 51
Pie Chart, Delivery History, 28

Polemount Bracket Adapter, 16
Power Jack, 8, 12
Power Switch, 11
Power Up, 15
Prime Tubing, 21, 22, 24, 36, 37, 51
Programming Screens, 29, 51
Programming the Pump, 17, 18, 21, 28, 32, 33, 48, 52

Before Beginning Program, 18
Manual Mode, 32
Patient Specic Parameters, 29
Programming Screens, 29, 51
Start the Pump, 19

Stop the Pump, 20
Protocol Library Summary, 29, 51
Pump,

development, 45

standards, 45
Pump Accessories, 15

CADD-Solis Medication Safety Soware, 15

cassette, 16

desktop AC Adapter, 15

Polemount Adapter Bracket, 16

Rechargeable Battery Pack, 15

Remote Dose Cord, 16
Pump Diagram, 11

front view, 11

rear view, 11
Pump Key, 16
Pump Screen, 17

R

Radiation, 43
Range,

hard limit, 29

so limit, 29
Rechargeable Battery Pack, 14, 15, 37, 39, 41, 49
Remote Dose Cord, 16, 30, 31, 40, 49
Remote Dose Cord Jack, 11, 12
Reports, 21, 22, 27, 51

Delivery History and Pie Chart, 28

Delivery Log, 28

Device Information, 29

Event Log, 28

Given and PCA Dose Counters, 27

PCA Dose Graph, 28

Protocol Library Summary, 29

View Reports, 26
Reservoir Volume, 17, 21, 22, 32, 33, 37, 41, 48, 52

S

Same Patient, 24
Security Settings, 21

administrator code, 21

clinician code, 21

keypad code, 21

56

Security Level Table, 21
Set Time and Date, 21, 22, 25, 51
So Limit, 29
Specications, 46

Administrator Settings Specications, 48

Delivery Specications, 48

General Pump Specications, 46
Start New Patient, 21, 22, 23, 51
Start New Protocol, Same Patient, 21, 22, 24, 51
Start the Pump, 19, 37, 38
Start-up curve, 53
Stop the Pump, 20
Subarachnoid Administration, 7
Symbols, 8
System Fault Alarm, 35

T

Tasks, 21, 22, 51

Adjust Admin Settings, 22, 27, 51

Adjust Alarm Volume, 21, 22, 26, 51

Adjust Backlight Intensity, 21, 22, 26

Give Clinician Bolus, 21, 22, 51

Prime Tubing, 21, 22, 24, 51

Set Time and Date, 21, 22, 25, 51

Start New Patient, 21, 22, 23, 51

Start New Protocol, Same Patient, 21, 22, 24, 51

View Reports, 22, 26, 51
Tests,

Accuracy Tests, 53
Time and Date, 21, 22, 25, 28, 33, 51
Trumpet Curve, 53

Index

U

Unlock, 11, 12, 21, 22, 29, 38, 52
USB Port, 11, 12

V

Volume,

alarm, 21, 22, 26, 51

reservoir, 17, 21, 22, 32, 33, 37, 41, 48, 52

sound, 52

W

WARNINGS, 1

57

58

Warranty

Limited Warranty

Smiths Medical MD, Inc. (the “Manufacturer”) warrants to
the Original Purchaser that the CADD®-Solis Ambulatory
Infusion Pump (“Pump”), not including accessories, shall
be free from defects in materials and workmanship under
normal use, if used in accordance with this Operator’s
Manual, for a period of two years from the actual date of
sale to the Original Purchaser. THERE ARE NO OTHER
WARRANTIES.

This warranty does not cover normal wear and tear and
maintenance items, and specifically excludes batteries,
administration sets, extension sets or any other accessory
items or equipment used with the Pump.

Subject to the conditions of and upon compliance with this
Limited Warranty, the Manufacturer will repair or replace
at its option without charge (except for a minimal charge for
postage and handling) any Pump (not including accessories)
which is defective if a claim is made during such two-year
period.

The following conditions, procedures, and limitations apply
to the Manufacturer’s obligation under this warranty:

A. PartiesCoveredbythisWarranty: This warranty
extends only to the Original Purchaser of the Pump. This
warranty does not extend to subsequent purchasers. The
Original Purchaser may be a patient, medical personnel,
a hospital, or institution which purchases the Pump for
treatment of patients. The Original Purchaser should retain
the invoice or sales receipt as proof as to the actual date of
purchase.

B. Warranty Performance Procedure: Notice of the
claimed defect must be made in writing or by telephone to
the Manufacturer as follows: Customer Service Department,
Smiths Medical MD, Inc., 1265 Grey Fox Road, St. Paul, MN
55112, [phone] (USA, Canada) or Smiths Medical
International Ltd. WD24 4LG, UK, [phone].
Notice to the Manufacturer must include date of purchase,
model and serial number, and a description of the claimed
defect in sufficient detail to allow the Manufacturer to
determine and facilitate any repairs which may be necessary.
AUTHORIZATION MUST BE OBTAINED PRIOR TO
RETURNING THE PUMP. If authorized, the Pump must
be properly and carefully packaged and returned to the
Manufacturer, postage prepaid. Any loss or damage during
shipment is at the risk of the sender.

C. Conditions of Warranty: The warranty is void if the
Pump has been 1) repaired by someone other than the
Manufacturer or its authorized agent; 2) altered so that its
stability or reliability is affected; 3) misused; or, 4) damaged
by negligence or accident. Misuse includes, but is not limited
to, use not in compliance with the Operator’s Manual or use
with nonapproved accessories. The Pump is a sealed unit,
and the fact that the seal has been broken will be considered
conclusive evidence that the Pump has been altered or
misused. Removal or damage to the Pump’s serial number
will invalidate this warranty.

D. LimitationsandExclusions: Repair or replacement of
the Pump or any component part thereof is the EXCLUSIVE
remedy offered by the Manufacturer. The following exclusions
and limitations shall apply:

1. No agent, representative, or employee of the
Manufacturer has authority to bind the Manufacturer to
any representation or warranty, expressed or implied.

2. THERE IS NO WARRANTY OF MERCHANTABILITY
OR FITNESS OR USE OF THE PUMP FOR ANY
PARTICULAR PURPOSE.

3. The Pump can only be used under the supervision of
medical personnel whose skill and judgment determine
the suitability of the Pump for any particular medical
treatment.

4. All recommendations, information, and descriptive
literature supplied by the Manufacturer or its agents are
believed to be accurate and reliable, but do not constitute

warranties.

E. Computer Program License:

1. The Pump is intended to be used in conjunction with
a particular Licensed Computer Program supplied
by Manufacturer and use of any other program or
unauthorized modification of a Licensed Computer
Program shall void Manufac turer’s warranty as set forth
above.

2. The Original Purchaser and any users authorized by the
Original Purchaser are hereby granted a nonexclusive,
nontransferable license to use the Licensed Computer
Program only in conjunction with the single Pump
supplied by Manufacturer. The Licensed Computer
Program is supplied only in machine-readable object
code form and is based upon Manufacturer’s proprietary
confidential information. No rights are granted under
this license or otherwise to decompile, produce humanly
readable copies of, reverse engineer, modify or create
any derivative works based upon the Licensed Computer
Program.

3. All other terms and conditions of this Limited Warranty

shall apply to the Licensed Computer Program.

The Manufacturer disclaims responsibility for the suitability
of the Pump for any particular medical treatment or for any
medical complications resulting from the use of the Pump.
The Manufacturer shall not be responsible for any incidental
damages or consequential damages to property, loss of profits,
or loss of use caused by any defect or malfunction of the
Pump.

This warranty gives the Original Purchaser specific legal
rights, and the Original Purchaser may have other legal rights
which may vary from state to state.

59

Smiths Medical MD, Inc.

St. Paul, MN 55112 USA
1 800.426.2448 (USA)
+1 651.633.2556
www.smiths-medical.com

x

2 6

@

Smiths Medical International Ltd.

WD24 4LG, UK
Tel: [phone]

Smiths Medical Australasia Pty. Ltd.

61 Brandl Street,
Eight Mile Plains, QLD 4113, Australia.
Tel: [phone]

CADD-Solis, CADD, and the CADD and Smiths Medical design marks are trademarks of the Smiths Medical family of companies.
The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries.
Allother names and marks mentioned are trade names, trademarks, or service marks of their respective owners.

© 2009 Smiths Medical family of companies. All rights reserved.

The products described are covered by one or more of the following U.S. Patent Nos.: 5181910, 5695473, 5935106, 5338157,
6024539, 5531697, 5647854, 6123686, 5364242, 5658250, 5935099, 6241704, 6475180, 7347836, 5876370. Other U.S. and
foreign patents pending.

2009-01
40-5497-51D

s