Smiths Medical CADD-Solis Operator's Manual

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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
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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 +44 (0) 1923 246434
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.
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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.
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.
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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.
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
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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.
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.
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
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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
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
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.
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
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.
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.
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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
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