CADD Solis VIP Model 2120 Continuous Delivery Mode Patient Information Guide Aug 2011

Your Clinician’s: Name: Phone number:

Instructions: Pump placement during bathing/showering:

Pump placement during sleep:

Storage of medication/fluid:

Notes:

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Table of Contents Introduction... 4 Warnings... 5 Cautions... 8 CADD®-Solis VIP Pump Diagrams...10 Installing New Batteries...13 Using the Rechargeable Battery Pack or AC Adapter...15 Turning the Pump On and Off...16 Pump Screens... 17 Removing a Cassette...20 Attaching a New Cassette...21 Priming the Tubing and Connecting to Your Catheter...25 Priming the Tubing without Changing the Cassette...27 Resetting the Reservoir Volume...29 Starting the Pump...31 Stopping the Pump...32 Setting a Delayed Start...33 Setting the Time and Date...34 What if I Drop or Hit the Pump?...37 Alarms and Messages...38 Alarm Help Screens...40 Notes...41

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Introduction Your doctor recommends the CADD®-Solis VIP ambulatory infusion pump as part of your treatment. The CADD®-Solis VIP pump can be carried with you and is designed to deliver medication into your body. Your physician has prescribed a therapy specifically for you. Your prescription is programmed into your pump by your health care provider according to your physician’s specific orders. This pump can be reprogrammed by your health care provider as your medication needs change. Your pump is programmed for Continuous delivery and is used for therapies that require an infusion of drug/fluid at a constant, programmed rate. Your health care provider will instruct you on the proper use of this pump. This guide is intended to supplement those instructions. Perform only those procedures for which you have received training. Before operating the pump, you should read the following list of warnings and cautions. It is important that you understand and follow these warnings and cautions.

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

Warnings • To avoid explosion hazard, do not use the pump in the presence of flammable anesthetics or explosive gases. • If the pump is used to deliver life-sustaining medication, an additional pump must be available. Pump failure suspends medication delivery. • Use of a syringe with the CADD® administration set may result in UNDERDELIVERY 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 underdelivery 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 VIP pump. You must regularly compare the volume remaining in the syringe to the displayed values on the pump (for example, Reservoir Vol. and Total Given) in order to determine whether underdelivery of medication is occurring. If necessary, contact your health care provider. • 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. Failure to observe this warning could result in patient injury or death.

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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. • 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. Failure to comply may result in fire or electrical shock. • When the pump is powered off, medication is not delivered, alarms are not sensed or indicated, the display is blank, the keypad does not respond to presses, and the amber and green lights are not lit. • A rechargeable battery pack that has reached the end of its useful life must be replaced with either another CADD®-Solis rechargeable battery pack or with 4 AA batteries. • 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. • 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

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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. • Do not use other AC adapters with the pump. AC adapters from other companies can damage the rechargeable battery pack and the pump, and could result in loss of power and nondelivery of drug. • Always clamp the tubing before removing the cassette from the pump. Removing the cassette without closing the clamp could potentially cause unregulated gravity infusion. • 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. • Do not prime the fluid path with the tubing connected to your catheter 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 your catheter. • If the pump is dropped or hit, inspect it for damage. Do not use a pump that is damaged or not functioning properly. If necessary, contact your health care provider.

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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. • 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. Contact your health care provider. • If delivery of an infusion is affected by a time or date change, an alarm message appears and must be confirmed. • Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment, 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 electronic circuitry. The best procedure to follow is to remove the pump 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

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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 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 affect how the pump works and may also cause damage to the pump. • Use only Smiths Medical accessories that are specified for use with the CADD®‑Solis VIP ambulatory infusion pump, as other brands may adversely affect pump operations. • Failure to push the AC adapter connector all the way into the power jack may result in an intermittent connection and the connector may dislodge, causing a loss of power to the 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.

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CADD®-Solis VIP Pump Diagrams Battery compartment Display Indicator lights Amber Green

USB port (used by clinician only) Blue AC power light AC power jack Remote dose cord jack (not used for Continuous therapy) Keypad

Green Light: Flashes when the pump is running and delivering medication. Amber Light: Flashes when the pump is stopped, an alarm exists, or the battery or the reservoir volume is low. If the amber light is continuously lit, the pump is inoperable and you must contact your health care provider. Note: At times, both indicator lights may flash. This means the pump is running, but will require your attention soon (for example, for a low battery or low reservoir volume).

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Display: Shows any information and messages. After a short time, the display turns itself off to save power. Press any key to turn the display back on.

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)

WARNING: When the pump is powered off, medication is not delivered, alarms are not sensed or indicated, the display is blank, the keypad does not respond to presses, and the amber and green lights are not lit.

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Keypad

   

  

 Starts and stops pump delivery.  “Soft keys” let you answer a question on the pump display. For example, the screen above this key may display “Yes,” in which case, pressing this key gives the question a “Yes” answer. “Soft keys” also let you move through some of the pump screens. Lets you scroll down menus or decrease values.

  Lets you scroll up menus or increase values.  Selects a menu item.  This key is not used for your therapy.

Note: The keys beep when pressed, if this feature has been turned on by your health care provider.

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Installing New Batteries Four new AA, 1.5 volt primary (non-rechargeable) alkaline batteries or the CADD®-Solis rechargeable battery pack must be used to power the pump. If the rechargeable battery pack is used, it can be recharged with the AC adapter. When Battery Low, Battery Depleted, or Rechargeable battery reached end of use appears in the pump display, change the batteries as soon as possible. Dispose of used batteries in an environmentally safe manner and according to any regulations that may apply. Note: Do not mix new and used batteries because it may affect low battery alarm times. Always select new batteries when replacing depleted ones. WARNING: • A rechargeable battery pack that has reached the end of its 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. • 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. • 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. • 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. • 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

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loss of power and nondelivery of drug and, depending on the type of drug being administered, could result in death or serious injury. • 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, and depending on the type of drug being administered, could result in death or serious injury. To install batteries or the rechargeable battery pack: 1. Make sure the pump is stopped and powered off.

2. Using your fingers or a coin, turn the knob on the battery door counterclockwise to open the battery door. 3. Hold the pump at an angle to remove the old batteries and insert 4 new AA batteries. Match the + and – markings on the batteries with the markings on the pump. OR: If using a rechargeable battery pack, insert it as shown. 4. Close the battery door and turn the knob on the battery door clockwise to lock. Note: • If the batteries are installed backwards, the pump will not power on. If the pump does not power on, check the batteries, making sure to match the + and – markings on the batteries to the pump. • Battery life may vary depending on the amount and rate of medication delivered, battery age, temperature, and active display time and backlight intensity (increasing backlight intensity shortens battery life). • Battery power is quickly depleted at temperatures below 10°C (50°F).

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Using the Rechargeable Battery Pack or AC Adapter You may have a rechargeable battery pack and an AC adapter to power your pump. The AC adapter can be used to power the pump and/or to recharge the rechargeable battery pack. When using the AC adapter, the pump must also have 4 AA batteries or the rechargeable battery pack installed as a backup. WARNING: Do not use other AC adapters with the pump. AC adapters from other companies can damage the rechargeable battery pack and the pump. This may 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. Note: For complete instructions, warnings and cautions, read the Instructions for Use that come with the rechargeable battery pack or AC adapter. To connect the AC Adapter:

Output power cord

1. Plug the AC power cord (the cord that plugs into your wall outlet) into the AC power input connector on the AC Adapter. AC power input 2. Plug the output power cord from the AC Adapter into the pump’s AC power jack (labeled “7V”). Push the connector firmly into the jack until it stops. When the AC adapter is AC power jack properly connected, the blue light and blue light next to the connector on the pump lights. If the pump is powered on, “AC Adapter Connected” appears briefly on the pump display and the battery status shows an AC power connection.

CAUTION: Failure to push the AC Adapter connector all the way into the power jack may result in an intermittent connection and the connector may dislodge, causing a loss of power to the pump.

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Turning the Pump On and Off To turn on the pump, press and hold the power switch .

When the pump powers on, it performs various self-tests. Watch and listen for the following:

Power Switch

• The green and amber lights flash. • The display shows a blue and amber rotating arc, followed by a CADD®‑Solis Ambulatory Infusion System display. If you see any stripes, or black or white pixels, or if your display appears faulty, contact your health care provider. • When power up completes, six beeps sound. Contact your health care provider if you do not hear the beeps, because there may be a problem with the audible alarms. • If any issues are detected during power on, alarms will sound and/or be displayed. If the alarms continue after you follow any on-screen help, contact your health care provider. To turn off the pump, press the power switch . When the “Power down?” message appears, press Yes. The pump then powers off.

When the pump is powered off: • • • •

The display is blank. Keypad presses are not detected. Medication is not infused. Alarms are not sensed, and audio and visual alarms are not displayed. • If the AC adapter is plugged in, the blue AC power light remains on. No other lights are lit. • If the pump is connected to AC power and a rechargeable battery pack is installed, the battery pack continues to charge.

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Pump Screens Menu screen













 

 Your therapy information  Pump status bar. This area may show messages and alerts.  Current reservoir volume  Delivery status of the pump: Stopped or Running  The battery type in use, approximate amount of battery life remaining, and AC adapter in use indicator

AA batteries

AA batteries with AC adapter

Rechargeable battery pack

Rechargeable battery with AC adapter

 Keypad lock status: locked or unlocked  Screen name and help text, if any  Work area/contents for the displayed screen 17

Note: The screens shown are examples. Your pump screens may vary based on your specific therapy. Home screen

      Current pump time  Current status of your infusion  A graphic of the infusion profile for your therapy, and the





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status of your infusion. The graphic uses the colors green, red, and gray. The colors indicate that the pump is running (green), or stopped (red). The graphic is entirely gray before the pump starts. Information about upcoming events that are important to the pump delivery. When the pump is running, messages may indicate: • When a delayed start will begin • When the reservoir will be empty Options for navigating the pump. Press the “soft key” below the displayed option to select it.

Pump Status Colors The colors green, amber, red, and blue in the pump status bar help you quickly recognize pump status. Similar to a traffic light, green means go, amber indicates caution, and red means stop: • Green: Pump conditions are satisfactory. • Amber: There is a condition to watch, but the current pump conditions are satisfactory. • Red: There is a warning condition that requires immediate attention and infusion has stopped. All high priority and system fault alarms display in red. • Blue: Low priority alarms and informational messages display in blue. On-screen text and help in the pump display provide more information when there are conditions or alarms that need your attention. If you cannot correct a condition or alarm by following the on-screen help, contact your health care provider. For information about alarm screens, see “Alarms and Messages” on page 38.

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Removing a Cassette The medication reservoir should be changed before new infusions, and when you receive reservoir volume empty or low alarms. Note: You should always have the supplies necessary to change your CADD™ medication cassette reservoir or CADD® administration set, as instructed by your health care provider. WARNING: Always clamp the 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 serious injury or death. To remove a cassette:

1. Make sure the pump is stopped before removing the cassette. For instructions, see “Stopping the Pump” on page 32. 2. Close the tubing clamp. 3. If the cassette is locked, insert the pump key into the cassette/keypad lock and turn it counter-clockwise to the unlocked position.

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

5. Remove and discard the CADD™ medication cassette reservoir or CADD® administration set as instructed by your health care provider.

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