Operators Manual
80 Pages
Preview
Page 1
X®
2100, 2110
Software version 3.0 or higher
s
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. The pump can be programmed with a protocol configuration consisting of a therapy, qualifier, and drug. Medication is delivered at a constant rate, and/or with an intermittent bolus, and/or with a patient dose. This manual concerns CADD®-Solis Ambulatory Infusion Pumps, models 2100 and 2110, with software version 3.0 or higher. Smiths Medical recommends that you maintain the same software version across all CADD®-Solis pump models in your facility. This manual is intended for clinician use only. Do not permit unauthorized clinicians or 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 security codes to those who are authorized. 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, contact Smiths Medical to see if an updated version is available.
Technical Assistance If you have comments or questions concerning the operation of the CADD®-Solis Ambulatory Infusion Pump, call the number given below. When calling, specify the pump software version number. This information is located in the device information report (See Reports on page 36). Smiths Medical is available to help with the programming and operation of the CADD®-Solis Ambulatory Infusion Pump. Smiths Medical ASD, Inc. St. Paul, MN 55112 USA 1 214.618.0218 www.smiths-medical.com European Distribution: Smiths Medical International Ltd. TN25 4BF, UK +44 (0) 1233 722100 Australian Distribution: Smiths Medical Australasia Pty. Ltd. 61 Brandl Street Eight Mile Plains, QLD 4113, Australia +61 (0) 7 3340 1300
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Read the entire Operator’s Manual before operating the CADD®-Solis Ambulatory Infusion Pump. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.
Contraindications • The pump is not to be used for delivery of blood or cellular blood products, as blood and cellular blood products will be damaged by the pumping mechanism.
• This pump is not to be used in any intra-articular space infusion.
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 allows 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 patients 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 suspends 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 suspends medication delivery.
• The user should ensure that the performance offered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended use.
• If the pump is dropped or hit, inspect it for damage. Do not use a pump that is damaged or 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 loses lubrication as it ages and as a result, the amount of under-delivery increases 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®-Solis pump.
The volume remaining in the syringe must be regularly compared to the displayed values on the pump (for example, reservoir volume and given), in order to determine whether under-delivery of medication is occurring. If necessary, appropriate action must be taken.
• The CADD®-Solis pump and accessories include small component pieces that could pose a choking hazard to young children.
• 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, CADD® extension set, or CADD® administration set is used
for epidural space or subarachnoid space drug delivery, it is strongly recommended that it be clearly differentiated from those used for other routes of infusion (for example, by color coding or other means of identification).
• 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, nondelivery of drug occurs. 3
• A rechargeable battery pack that has reached the end of it useful life must be replaced with either another CADD®-Solis rechargeable battery pack or with 4 AA batteries.
• 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.
• Carefully route tubing, cords, and cables to reduce the possibility of patient entanglement or strangulation.
• Attach the cassette properly. A detached or improperly attached cassette could result in unregulated gravity infusion of medication from the reservoir or a reflux of blood.
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 the tubing before removing the cassette from the pump. Removing the cassette without closing the clamp could potentially cause unregulated gravity infusion.
• Do not disclose pump security codes or any other information that would allow the patient or unauthorized clinician complete access to programming and operating functions.
• Do not leave the pump unattended while unlocked. Many programming functions are accessible while the pump is unlocked.
• Exercise care when using the clinician bolus function. Because there are no limits on the frequency
of delivering a bolus, and because the bolus amount may be set as high as 50 mL (or the mg or mcg equivalent), do 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 deliver the programmed value, or cancel to leave the screen.
• Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism.
• To prevent air embolism, ensure that the entire fluid path is free of all air bubbles before connecting to the patient.
• The remote dose cord is for patient use only. Operation by anyone other than the patient may cause overdelivery of medication.
• The manual mode does not contain programming limits. Carefully review each parameter to ensure it accurately matches the prescription.
• Ensure that debris is not allowed to build up on the pressure plate surface of the pumping mechanism.
Inspect the air detector sensor slot and remove any debris. A blocked air detector sensor may not detect air present in the fluid path.
• 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.
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• System delivery inaccuracies beyond ± 6% may occur as a result of back pressure or fluid resistance,
which depends upon temperature, drug viscosity, catheter size, extension set tubing (for example, microbore), in-line components (such as filters and needleless access connectors), and placing the infusion reservoir and/or pump above or below the level of the patient. System delivery inaccuracy may result in under or overdelivery of medication.
• 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
• The pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, you should verify normal operation of the pump in the configuration in which it is to be used.
• Common portable and mobile consumer electronic devices may cause interference with the pump.
Observe the pump to verify normal operation. If abnormal performance is observed, it may be necessary to reorient or relocate the pump away from radio frequency transmitting devices.
• Residential/facility wiring must comply with all applicable electrical codes. Do not bypass power cord connections. Do not remove a prong from the power cord.
• 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.
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Cautions • Do not operate the pump at temperatures below 2°C (36°F) or above 40°C (104°F) to avoid damaging the electronic circuitry.
• Do not store the pump at temperatures below –20°C (–4°F) or above 60°C (140°F) to avoid damaging
the electronic circuitry. Do not store the pump with a CADD™ medication cassette reservoir or CADD® administration set attached.
• Do not expose the pump to humidity levels below 20% or above 90% relative humidity to avoid damaging the electronic circuitry.
• CADD® pumps are sealed units. A broken or 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.
• 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.
• Use only Smiths Medical accessories that are specified for use with the CADD®-Solis Ambulatory Infusion Pump.
• If you are using a CADD™ medication cassette reservoir in which the medication is frozen, thaw at
room temperature only. Do not heat in a microwave oven as this may damage the product and cause leakage.
• Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak 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.
• The pump SHOULD NOT BE DIRECTLY IRRADIATED by therapeutic levels of ionizing radiation
due to 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 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. Exposing the pump to strong magnetic fields that exceed 600 gauss may cause irreversible damage, rendering the pump inoperable.
• 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 affect how the pump works and may also cause damage to the pump.
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Table of Contents
General Description
References and Troubleshooting
References and Troubleshooting
Understanding the Alarms and Messages... 50 System Fault Alarm... 50 High Priority Alarm... 50 Medium Priority Alarm... 50 Low Priority Alarm... 51 Informational Message... 51 Alarms and Messages, Alphabetical List... 52 Index
Installing the Batteries... 17 Replacing the Battery Door... 18 Power Up... 19 Power Down... 19 Description of Pump Accessories... 20 CADD™-Solis Medication Safety Software... 20 AC Adapter... 20 Rechargeable Battery Pack... 20 Cassette, Extension Set, Administration Set... 20 Remote Dose Cord... 21 Polemount Bracket Adapter... 21 Polemount Bracket... 21 Pump Key... 21 Programming the Pump: General Instructions . 22 The Pump Screen... 22 Color Display... 23 Before Programming... 23 Attach a Cassette... 24 Remove a Cassette... 26 Start the Pump... 26 Stop the Pump... 26
Programming and Operation
Pump Setup
Security Settings... 27 Security Level Table... 27 Autolock... 29 Entering Security Codes... 29 Tasks... 30 Give Clinician Bolus... 30 Start New Patient... 31 Start New Protocol, Same Patient... 32 Prime Tubing... 32 Set Time and Date... 33 Adjust Backlight Intensity... 34 Adjust Alarm Volume... 35 View Reports... 35 Adjust Admin Settings... 35 Reports... 36 Intermittent Bolus Status... 36 Given and PCA Dose Counters (Given and PCEA Dose Counters)... 36 PCA Dose Graph (PCEA Dose Graph)... 37 Intermittent Bolus Graph... 38 PCA and Intermittent Graph (PCEA and Intermittent Graph)... 38 Delivery History and Pie Chart... 38 Delivery Log... 39 Event Log... 39 Protocol Library Summary... 40 Device Information... 40 Patient Specific Parameters (Programming Screens)... 41 Intermittent Bolus... 42 Bolus Interval... 42 Next Bolus... 43 Continuous Rate... 43 PCA Dose (PCEA Dose)... 44 PCA Lockout (PCEA Lockout)... 44 Hourly Limit... 45 Max Doses/Hr... 46 Reservoir Volume... 46 Manual Mode Programming... 47
Pump Setup
Introduction... 9 Indications... 9 Contraindications... 9 Epidural/Subarachnoid Administration... 9 Analgesics... 9 Anesthetics... 9 Symbols... 10 Pump Diagram... 12 Description of the Keys, Components, Ports, and Connectors... 13 Indicator Lights... 13 Display with Backlighting... 13 Keypad... 13 Power Switch... 14 Power Jack... 14 USB Port... 14 Remote Dose Cord Jack... 14 Battery Compartment... 14 Cassette Latch... 14 Cassette/Keypad Lock... 14 Delivery Methods... 15
Programming and Operation
General Description
Technical Assistance... 2 Contraindications... 3 Warnings... 3 Cautions... 6
7
General Description Pump Setup
Cleaning the Pump and Accessories... 59 Exposure to Radiation or Magnetic Resonance Imaging (MRI)... 59 Scroll Ranges... 60 Technical Description... 62 Standards used in development of the pump... 62 Specifications (Nominal)... 63 General Pump Specifications... 63 Delivery Specifications... 68 Administrator Settings Specifications... 69 Electromagnetic Emissions and Immunity Declarations... 70 Collect Separately... 72 Programming Screens/Menus Maps... 73 Default Factory Settings... 74 Accuracy Test Results... 75 Limited Warranty... 76
Index
References and Troubleshooting
Programming and Operations
Index
8
General Description
General Description General Description
Introduction The CADD®-Solis Ambulatory Infusion System provides measured drug therapy to patients in hospital or outpatient settings. Therapy should always be overseen by a physician or a certified, licensed healthcare professional. As appropriate, the patient should be instructed in using the pump.
Indications The CADD®-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, and/or an intermittent bolus, and/or with patient-controlled demand doses.
Contraindications • The pump is not to be used for delivery of blood or cellular blood products, as blood and cellular blood products will be damaged by the pumping mechanism.
• This pump is not to be used in any intra-articular space infusion.
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. The inadvertent use of injection sites for infusion of such drugs may cause serious patient injury or death.
•
If a CADD™ medication cassette reservoir, CADD® extension set, or CADD® administration set is used for epidural space or subarachnoid space drug delivery, it is strongly recommended that it be clearly differentiated from those used for other routes of infusion (for example, by color coding, or other means of identification). Drugs not intended for epidural or subarachnoid space infusion could result in 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.
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General Description
General Description
Symbols Symbols on the Pump and Labels Symbol
f
Definition
Symbol
Caution
Power on/off button
1 Consult instructions for use < > J
B
Soft key
Serial number
U
Up button
Date of manufacture
D
Down button
S
Select button
9
Start/Stop button
@
PCA dose button
Authorized representative in the Australian representative
P Temperature limitation _ Humidity limitation i Atmospheric pressure limitation
E
Z
Cassette unlock/lock
Catalog number
@ European Community
J K
Definition
AA battery location, positive terminal faces up AA battery location, negative terminal faces up
Type CF equipment
AA battery location, positive terminal faces up
Class II equipment
AA battery location, negative terminal faces up
Splashproof-water splashed against the pump housing will have no harmful effects.
USB port
Collect separately
Direct current (power jack) Remote dose cord jack
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General Description Symbols on the Pump Display Definition
Symbol
Definition
Reservoir volume
Item highlighted in the work area is at the top of the menu. Press D to scroll down.
Charge level of rechargeable battery pack
Item highlighted in the work area is at the bottom of the menu. Press U to scroll up.
Charge level of rechargeable battery pack. AC adapter connected.
Home screen
Charge level of AA batteries
Keypad is locked
Charge level of AA batteries. AC adapter connected.
Keypad is unlocked
No battery installed, AC power only
Appears next to a parameter that was reviewed and accepted.
Incompatible battery
On edit screens. Indicates current parameter value. Press U or D to scroll up or down to edit the value.
Incompatible battery. AC Adapter connected.
On edit screens with a menu of options. Indicates which setting is being selected.
Pump status is Running.
The requested action can not be performed.
Pump status is Paused or in KVO.
More data is available. On PCA dose report only.
Pump status is Stopped.
Review screen
There are more items to see in the work area. Press U or D to scroll up or down.
Saving
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General Description
Symbol
General Description
General Description
Pump Diagram Front View Battery Compartment Display Indicator Lights Amber Green
USB Port Blue AC Power Light AC Power Jack Remote Dose Cord Jack Keypad
Rear View
Power Switch
Cassette/Keypad Lock (Unlock/Lock)
Cassette Latch Cassette (The part of the CADD™ medication cassette reservoir or CADD® administration set that attaches to the pump)
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Serial number
General Description
Description of the Keys, Components, Ports, and Connectors When the pump is powered, one or both of the indicator lights 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 briefly describes 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).
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.
• Therapies incorporating patient-controlled analgesia are configured with the CADD™-Solis Medication Safety Software to display either “PCA” (patient-controlled analgesia) or “PCEA” (patient-controlled epidural analgesia). The examples shown in this manual display only “PCA”. However, menus, submenus, and screens on the pump will appear with “PCEA” if they are programmed to do so.
• If you press stop/start 9, the display reappears with a message asking if you wish to start or stop the pump.
• If you press PCA dose @ while the pump screen is blank, the pump delivers a PCA dose, if available. Keypad The pump has either a gray or yellow 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 do not beep if the key beep function is turned off in the protocol or the administrator settings.
51
stop/start
select
PCEA dose
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. Used to select a menu item. Allows the patient to request a PCA (PCEA) dose. If the remote dose cord is connected this key is inactive. 13
General Description
Indicator Lights
General Description
General Description
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 AC Adapter on page 20 for more information.)
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 21 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 17 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 detects whether the cassette is latched properly. Delivery stops and an alarm occurs if the cassette becomes unlatched. (See Attach a Cassette on page 24 and Remove a Cassette on page 26.)
Cassette/Keypad Lock 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 27.)
14
General Description
Delivery Methods • • • •
General Description
The pump provides the following methods of delivery: Continuous rate: infusion of drug at a constant, programmed rate Intermittent bolus (IB): a series of doses automatically delivered at regular, programmed intervals PCA dose: a demand dose activated by the patient
Clinician bolus: a dose activated by the clinician Each of the methods may be programmed individually or in combination with each other. The figures below illustrate examples of combined delivery methods. Ranges, programming increments, rates, and volumes are listed in Specifications (Nominal) on page 63. Example 1: Continuous Rate, PCA Doses, and Clinician Bolus
Dosage
Clinician Bolus (used here as a loading dose) PCA Lockout
PCA dose
PCA dose denied
PCA dose
PCA dose
Continuous Rate
Time Example 2: Intermittent Boluses and PCA Doses (PIB)
Dosage
Delivery of PCA dose moves out the delivery of the next IB.
IB
IB
IB
IB PCA dose
Next Bolus delay
Intermittent Bolus (IB) Interval
Bolus Interval Type (set as PCA Lockout)
PCA dose denied
Time
PCA Lockout
15
General Description
Delivery of PCA dose moves out the delivery of the next IB.
Dosage
General Description
Example 3: Intermittent boluses and PCA doses (PIB).
IB
IB
IB
IB PCA dose
Next Bolus delay
16
Intermittent Bolus (IB) Interval
Bolus Interval Type (set as Bolus Interval)
PCA dose denied
Intermittent Bolus (IB) Interval
Time
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 because it may affect low battery alarm times. Always use four new batteries when replacing depleted ones. CAUTION: 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.
WARNING:
•
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, 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 occurs and depending on the type of drug being administered, could result in death or serious injury to the patient.
•
A rechargeable battery pack that has reached the end of it useful life must be replaced with either another CADD®-Solis rechargeable battery pack or with 4 AA batteries. Using rechargeable battery packs from other manufacturers could result in fire or explosion.
•
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 and, depending on the type of drug being administered, could result in death or serious injury to the patient.
•
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 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.
17
Pump Setup
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 stops. If an AC adapter is not connected and the batteries are removed, delivery stops and the pump loses power. Dispose of used batteries in an environmentally safe manner, and according to any regulations which may apply.
Pump Setup To install the batteries:
Pump Setup
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.
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.
OR
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.
Note: • 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 is 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).
18
Pump Setup
Power Up Press and hold the power switch to turn the pump on. The pump starts the power up sequence during which it performs various self-tests, test for alarm conditions, and then asks you if you want to start a new patient. Watch for the following during power-up:
• Both the green and amber indicator lights flash. • The display quickly flashes gray, then blue. An amber swirl then fills 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.
• 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. 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.
Power Down Press the power switch to turn the pump off. You must acknowledge the “Power down?” prompt by selecting Yes. The pump then powers down. Be aware of the following conditions when the pump is powered down:
• • • • • • • • • • •
The display is blank. Keypad presses are not detected. The remote dose cord does not function. Medication is not infused. Alarm conditions are not sensed. Audio alarms do not sound. Visual alarms are not displayed. Communication with CADD™-Solis Medication Safety Software is not possible. If the AC adapter is plugged in, the blue AC power light is on. No other lights are lit. The internal battery used to retain time and date does not charge. If the pump is connected to AC power and a rechargeable battery pack is installed, the battery pack continues to charge.
19
Pump Setup
• If any issues are found while the pump is performing the self tests, alarms will sound (e.g., if the battery
Pump Setup
Description of Pump Accessories CAUTION: Use only Smiths Medical accessories that are specified for use with the CADD®-Solis Ambulatory Infusion Pump.
CADD®-Solis accessories may be obtained through the Customer Service department at Smiths Medical. For detailed instructions and warnings applicable to each accessory, refer to the instructions for use provided with the product.
CADD™-Solis Medication Safety Software
The CADD™-Solis Medication Safety Software allows you to create and manage protocol libraries and then send them to the pump. See the installation guide and online help for more information.
Pump Setup
AC Adapter The 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.
Rechargeable Battery Pack The rechargeable battery pack is an alternative to using four AA batteries. The rechargeable battery pack can be recharged with the AC adapter, either inside or outside of the pump.
Cassette, Extension Set, Administration Set The cassette is the part of the CADD™ 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:
• CADD™ medication cassette reservoir with a CADD® extension set • CADD® administration set • CADD® high volume administration set (with pump model 2110 only) 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.
• Carefully route tubing, cords, and cables to reduce the possibility of patient entanglement or strangulation. Failure to observe this warning could result in patient injury or death.
Note: • A CADD® set with free-flow protection must be used in order to prevent free-flow.
• The maximum delivery rate is 250 mL/hr on a model 2100 pump, and 500 mL/hr on a model
2110 pump. Programmed delivery rates exceeding 250 mL/hr require the use of a high volume administration set and a model 2110 pump. Attempting to attach a high volume administration set to a model 2100 pump will result in an alarm, and the pump will not run. Do not manually adjust the delivery rate to override pump programming without written authorization from the prescribing physician.
• Smiths Medical recommends that the appropriate supplies needed to replace the cassettes are available in case of a damaged cassette.
• For detailed instructions and warnings pertaining to the CADD™ medication cassette reservoir or
CADD® administration set, refer to the instructions for use supplied with the product for preparing the product for use.
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