2110 Software version 4.
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.
Read this 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.
• When the upstream occlusion sensor is turned off, the pump does not detect occlusions upstream between the pump and the reservoir. Periodic inspection of the fluid path for kinks, a closed clamp, or other upstream obstructions is recommended. Upstream occlusions may result in underdelivery of medication. • 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.
• 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.
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.
Table of Contents General Description Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Epidural/Subarachnoid Administration . . . . . . . . . . 9 Analgesics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Anesthetics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms and Messages. . . . . . . . . . . . . . . . . . . . . . . . . . 55 Types of Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 System Fault Alarm. . . . . . . . . . . . . . . . . . . . . . . . 55 High Priority Alarm . . . . . . . . . . . . . . . . . . . . . . . . 55 Medium Priority Alarm. . . . . . . . . . . . . . . . . . . . . 55 Low Priority Alarm. . . . . . . . . . . . . . . . . . . . . . . . 56 Alarm Help Screens. . . . . . . . . . . . . . . . . . . . . . .
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.
• Intermittent bolus (IB): a series of doses automatically delivered at regular, programmed intervals • PCA (PCEA) 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 10.
General Description General Description Example 3: Intermittent Boluses (IB) and PCA doses, with Bolus Interval Type set as Bolus Interval Dosage Delivery of PCA dose moves out the delivery of the next IB.
General Description General Description Symbols Symbols on the Pump and Labels Symbol f < > J H @ P _ i J K IP24 Symbol Definition Caution Power on/off button Follow Instructions for Use (The symbol appears on the device with a blue background.
General Description General Description Symbols on the Pump Display Symbol 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.
General Description General Description Pump Diagram Compartment for AA batteries, rechargeable battery, or CADD®-Solis Communication Module (with integrated rechargeable battery) Front View 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) 14 Serial
General Description Pump Components, Ports, and Connectors General Description Indicator Lights 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.
General Description General Description WARNING: To avoid electric shock, do not touch the Power Jack, Remote Dose Cord Jack, USB Port, Battery Terminals, or any other connectors and the patient simultaneously. 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.
General Description Upstream Occlusion Sensor WARNING: When the upstream occlusion sensor is turned off, the pump does not detect occlusions upstream between the pump and the reservoir. Periodic inspection of the fluid path for kinks, a closed clamp, or other upstream obstructions is recommended. Upstream occlusions may result in underdelivery of medication. If undetected, these occlusions could lead to death or serious injury to the patient.
General Description General Description For more information about installing the CADD®-Solis Communication Module, see the documentation provided with the module. For configuration of the wireless network settings of the pump and communication module see operators manual for the Network Setup Utility software. Pump Key The pump key is used to securely lock a cassette or administration set to the pump. It can also be used to lock and unlock the keypad, if allowed by the protocol setting.
General Description Polemount Swivel General Description The polemount swivel allows the pump to rotate while it is attached to the CADD®-Solis polemount bracket. With the swivel attached, the pump can be tilted or rotated 230° for easy viewing of the display. The swivel can not be used in a LockBox. Pouches and Backpacks Several styles of pump pouches and backpacks are available.
Pump Setup Pump Setup Installing the Batteries Four AA, 1.5 volt primary (non-rechargeable) alkaline batteries (for example, Duracell® PC1500 / MN1500, IEC LR6), the Smiths Medical rechargeable battery pack, or the CADD®-Solis Communication Module (with integrated rechargeable battery) are required for use in the CADD®‑Solis pump. Note: Smiths Medical does not recommend mixing new and used AA batteries because it may affect low battery alarm times.
Pump Setup To install the batteries or rechargeable battery pack: 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 counterclockwise and open the battery door. – OR – Pump Setup 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.
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 and tests for alarm conditions. 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.
Pump Setup Programming the Pump: General Instructions The Pump Screen The sample screens 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. Pump Setup i The therapy, qualifier, and drug from the current protocol.
Pump Setup Color Display The CADD®-Solis pump display uses color to help the clinician recognize critical information quickly and easily. Protocol Screen Colors Your facility may choose to relate a specific color to each protocol in its library. This is customizable by your PharmGuard® Medication Safety Software system administrator.
Pump Setup Attaching a Cassette WARNING: • 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, which could result in death or injury to the patient.
Pump Setup Pump Setup 6. Lift the cassette latch into the closed position. You should be able to move the latch into the closed position with minimal to no resistance. If you experience resistance when lifting the cassette latch, DO NOT FORCE the latch. If you are unable to attach the cassette to the pump with minimal to no resistance, the cassette is not in the proper latching position. If the pump does not latch easily, unlatch the cassette and repeat the process.
Pump Setup Removing a Cassette WARNING: 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, which could result in patient injury or death. To remove the cassette: 1. Make sure the pump is stopped before removing the cassette. 2. Close the tubing clamp. 3.
Programming and Operation Programming and Operation Security Settings Security settings are used to limit patient and unauthorized clinician access to certain programming and operating functions of the pump. Pump functions are protected by three different security codes, and may also be protected by the cassette/keypad lock. The security level table below lists the functions that are available under each security code.
Programming and Operation Pump Operations and Programming Stop/Start 9 Keypad Security Locked Keypad Security Unlocked Administrator Security Unlocked Running Stopped Running Stopped Running Stopped Running Stopped * * Reset Reservoir Volume Start PCA Dose @ Clinician Security Unlocked Change (Titrate) Continuous Rate * * * * Change (Titrate) Intermittent Bolus * * * * Change (Titrate) Bolus Interval * * * * Change Next Bo
Programming and Operation Autolock The CADD®-Solis ambulatory infusion pump is designed to meet both safety and usability needs. The autolock feature reduces the chance of unauthorized pump programming. When the keypad is unlocked with a security code and left unlocked, the software automatically locks the keypad. The autolock feature takes affect on the Home screen approximately 30 seconds after the last key press, or when reverting back to the Home screen from other screens.
Programming and Operation Tasks The tasks menu leads you to most of the pump’s operating functions. On this menu, you can perform a range of tasks from giving a clinician bolus, starting a new patient, to changing the date and time, turning wireless on/off, or adjusting the PharmGuard® system administrator settings. Some of the items on the tasks menu are protected by the various security levels. To learn more about the security codes, see Security Settings on page 28.
Programming and Operation 4. Unlock the keypad using the pump key (if allowed) or press U or D to enter the clinician code (or a higher level code). Press S to advance to the next digit. Once the code is entered, select Accept Value. Note: If you enter a code that you believe is correct and receive a wrong code error, check the screen to see if the clinician code is customized. If the code was not customized, it was entered incorrectly. Retry. If the code is customized, use the custom clinician code.
Programming and Operation 6. Press U or D to highlight the desired qualifier and press S. 7. Press U or D to highlight the desired drug(s) and concentration, and press S. 8. Unlock the keypad using the security code. 9. The new protocol is displayed on the screen and the pump asks if you have selected the correct therapy, qualifier, drug, and concentration. Confirm that you have selected the correct profile, therapy, qualifier, drug, and concentration or units.
Programming and Operation Prime Tubing Priming the tubing is done to fill the tubing downstream of the pump with fluid, removing any air bubbles. Prime the tubing before connecting it to the patient’s infusion set or indwelling catheter. The pump must be stopped and you must enter the security code or the cassette/keypad lock must be unlocked. Note: The air detector is disabled while the pump is priming.
Programming and Operation Note: • If you manually update the time while the pump is in use, the timestamps in the event and delivery logs are not updated to reflect daylight saving time prior to the change. All events record the reported pump time from when the event actually occurred. For your reference, the event log records the time when it was changed.
Programming and Operation 2. Unlock the keypad using the security code or the pump key. 3. Press U or D to scroll to the correct month and press S to navigate to the day. 4. Press U or D to scroll to the correct day and press S to navigate to the year. 5. Press U or D to scroll to the correct year and select Save. To set the time format: 1. Press U or D until Time Format is highlighted and press S. 2. Unlock the keypad using the administrator code. 3.
Programming and Operation 3. Unlock the keypad using the security code or the pump key. 4. Press U or D to scroll from 1 to 10. The pump displays the intensity of each number as it appears. Once you have found the desired backlight intensity, select Save. Adjust Alarm Volume The adjust alarm volume feature allows you to determine the volume of the alarms in the protocol. You may choose between 3 volumes: low, medium, and high. Note: • Use of a pouch, lockbox, or backpack may muffle audible alarms.
Programming and Operation Turn Wireless On/Off When the pump has a CADD®-Solis Communication Module installed, its wireless radio can be turned off (and on) as necessary. The wireless capabilities are used to allow the pump to communicate to a PharmGuard® Server system (i.e., sending pump data to the server, and receiving pump library and software updates from the server).
Programming and Operation Reports The reports screen is used to access a variety of reporting and record-keeping functions. Note: Therapies incorporating patient-controlled analgesia are configured with the PharmGuard® Medication Safety Software to display either “PCA” or “PCEA”. Most examples shown in this manual display “PCA”. However, menus, submenus, and screens on the pump will appear with “PCEA” if they are programmed to do so. You may access the reports from the Home screen or the Tasks menu.
Programming and Operation To view the Given and PCA dose counters: 1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Given and PCA Dose Counters and press S. To clear the total given counters: 1. Press U or D until the Given Amount and Given Volume section is highlighted. 2. Select Clear Given. To clear the PCA doses given and attempted counters: Programming and Operation 1. Press U or D until the PCA Doses Given and PCA Doses Attempted section is highlighted. 2.
Programming and Operation Intermittent Bolus Graph This screen displays the number of intermittent boluses given in 30 minute increments starting from the current time to 8 hours in the past or to the start of a new protocol or patient. The intermittent bolus graph can be viewed at any time, with the pump running or stopped. To view the intermittent bolus graph: 1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Intermittent Bolus Graph and press S.
Programming and Operation Current Profile / Protocol (if configured) The Current Profile / Protocol screen shows the profile, therapy, qualifier, drug and units in use based on your selected protocol or manually programmed protocol. To view the current profile / protocol: 1. From the Home screen, select Reports. 2. From the Reports menu, press U or D to choose Current Profile / Protocol and press S.
Programming and Operation Event Log The event log records the following types of events: hourly given totals, dose delivery, alarms, error codes, power source changes (including power losses), cassette changes, protocol library changes, and changes to pump programming or settings. The pump records the time and date of each event, and lists events in order, with the most recent at the bottom of the screen through the last 5000 events.
Programming and Operation Wireless Status This screen is available only when a CADD®-Solis Communication Module is installed. This report is used by network or systems adminstrators to view the current status of the pump wireless module and its connectivity to the wireless network If the Communication Module is incompatible with the wireless network configuration programmed in the pump, the status reported on the screen will be “Incompatible Configuration”.
Programming and Operation Patient Specific Parameters (Programming Screens) The patient specific parameters are found on the Home screen and can be edited within limits that are set up by the PharmGuard® system administrator in the protocol. The PharmGuard® system administrator determines which parameters can be viewed and/or edited on the Home screen, as well as the initial values of the parameters.
Programming and Operation Intermittent Bolus Each intermittent bolus is the infusion of a specific volume of drug at the programmed max delivery rate value. Programming the intermittent bolus is limited by the values of the max delivery rate, bolus interval, and continuous rate. Intermittent boluses are delivered at regular time intervals based on the programmed Bolus Interval, and as allowed by intermittent bolus limits, bolus interval limits, and bolus type.
Programming and Operation Next Bolus The Next Bolus setting is the length of time between when the pump starts “Running” until when the first intermittent bolus will be delivered. After the initial intermittent bolus is delivered, Next Bolus functions as a timer to count down the time remaining until the next intermittent bolus is programmed to deliver. Note: The Next Bolus countdown does not begin until you start the pump by pressing the stop/start 9 button.
Programming and Operation Continuous Rate The continuous rate is the constant, hourly rate the drug is delivered at while the pump is running. Programming the continuous rate is limited by values of the max delivery rate, bolus interval, and intermittent bolus. For more information, contact your PharmGuard® system administrator. The continuous rate value can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the continuous rate: 1.
Programming and Operation PCA Lockout (PCEA Lockout) The PCA lockout is the minimum amount of time that must pass after a PCA dose and before the patient can successfully request another PCA dose. It is also the minimum time that must elapse between the time an intermittent bolus starts and the time that the next PCA dose is available. The PCA lockout can be edited while the pump is running or stopped (if the keypad is unlocked). To edit the PCA lockout: 1.
Programming and Operation Note: If the hourly limit or the max doses/hr settings are not visible on the Home screen, your facility’s PharmGuard® system administrator has chosen not to require a delivery limit beyond the PCA lockout. To edit the max doses/hr: 1. From the Home screen, press U or D to choose Max Doses/Hr and press S. 2. Unlock the keypad using the security code or the pump key. 3. Press U or D until you reach the desired max doses/hr value and select Save.
Programming and Operation Manual Mode Programming The manual mode is for situations when the doctor’s orders may not match any of the protocols in the library, or when a protocol library is not available. The screen for the manual mode is always black in color and the therapy, qualifier, and drug and concentration listing will look like this (see page 23 for a diagram of the pump screen): Units and concentration chosen after the manual mode is selected.
Programming and Operation Manual Mode Initial Settings Programming and Operation Pump Function Protocol Setting Programming Units User selects mL, mg, or mcg Concentration User selects if the programming units are mg or mcg. Range is 0.1–100 mg/mL or 1–500 mcg/mL Continuous Rate On/Off On Continuous Rate Limits Range is 0–100 mL/hour (or mg or mcg equivalent). Value is 0 PCA Dose On/Off On PCA Dose Limits Range is 0–50 mL (or mg or mcg equivalent).
Programming and Operation To use the manual mode: 1. Determine whether you are starting a new patient, or starting a new protocol with the same patient. Select the appropriate task from the tasks menu. 2. On the Select Therapy screen, scroll to the bottom of the therapies until [Program Manually] is highlighted and press S. The protocol title bar is displayed in the color black. Instead of a therapy and qualifier, you see the Manual Program screen (see page 51). 3. Unlock the keypad using the security code.
Programming and Operation Wireless Function (Communication Module) When the pump has the optional CADD®-Solis Communication Module installed, its wireless capabilities allow the pump to communicate to a PharmGuard® Server system (i.e., sending pump data to the server, receiving pump library updates, and software updates (pump and communication module) from the server). The communication module also features a built in rechargeable battery to power the pump.
References and Troubleshooting References and Troubleshooting Alarms and Messages The pump can produce multiple alarms. For many of the alarms, you have one or more options available: • Acknowledge—the alarm clears from the screen. • Silence—the alarm stays on the screen, but is silenced for 2 minutes before it sounds again. The alarm continues until it is acknowledged or resolved. • Power Down—available from some select alarms, this option powers the pump down.
References and Troubleshooting Low Priority Alarm A low priority alarm does not stop the pump if it is running. The alarm is accompanied by a blue screen, and it persists for 5 seconds unless it is acknowledged by the press of a key or the condition that triggered the alarm goes away before the 5 seconds have passed. (Some low priority alarms persist for longer than 5 seconds.
References and Troubleshooting 3. Follow the applicable instructions provided on the help screen. To page through all available help screens, press Next repeatedly. Press Acknowledge at any time to exit Help. 4. “Retry Help” appears when no additional help steps are available. To page through the help screens again, press Retry Help. The Alarm screen reappears as in Step 2 above. Repeat Steps 2 and 3. When the alarm clears, the help screens will no longer be displayed.
References and Troubleshooting Alarms and Messages, Alphabetical List Alarms and Messages (Screen is blank and alarm is sounding) Description / Corrective Action High The pump was delivering and the batteries or the CADD®-Solis Communication Module with integrated rechargeable battery was removed, the battery door was opened, or the batteries are too depleated to power the pump. The pump lost power and is no longer delivering.
References and Troubleshooting Alarms and Messages Description / Corrective Action Battery removed. Pump stopped. High The rechargeable battery pack, CADD®-Solis Communication Module with integrated rechargeable battery, or the 4 AA batteries were removed. The pump was delivering and is now stopped. Select Acknowledge to clear the alarm. • Install 4 new AA batteries, a fully charged rechargeable battery pack, or CADD®-Solis communication module.
References and Troubleshooting Alarms and Messages Alarm Priority Description / Corrective Action Cannot start pump without a battery. Medium The pump does not have any batteries installed. To start delivery, good batteries must always be installed even when an external source of power is connected. Select Acknowledge to clear the alarm. Install 4 new AA batteries, rechargeable battery pack, or the CADD®-Solis Communication Module with integrated rechargeable battery. If appropriate, start the pump.
References and Troubleshooting Alarms and Messages Current settings require standard volume set. Change cassette. Alarm Priority Description / Corrective Action High The CADD® high volume administration set cannot be used with the selected protocol. The pump is stopped and will not run. Replace the high volume administration set with a standard volume cassette to continue.
References and Troubleshooting Alarms and Messages Alarm Priority Description / Corrective Action Medium The AC adapter’s output voltage is too high. Select Acknowledge to clear the alarm. The AC adapter is faulty, remove from service. High A key may be pressed down. The pump is stopped and will not run. Make sure there is nothing pressing on any of the keys.
References and Troubleshooting Alarms and Messages Alarm Priority Description / Corrective Action Protocol library updating. Reselect protocol when update is complete. Medium A new or updated library is currently being downloaded into the pump. You cannot select any new protocols while this update is in process. Select Acknowledge to clear the alarm or it will automatically clear when the update is complete. Pump does not have a protocol library.
References and Troubleshooting Alarms and Messages Reservoir volume low. Alarm Priority Description / Corrective Action Medium / Medium: The programmed reservoir volume trip point has been Low* reached, indicating the level of fluid in the reservoir is low. Select Acknowledge to clear the alarm. Low: The reservoir volume value is low, indicating that the level of fluid in the fluid container is low. Select Acknowledge to clear the alarm or the alarm automatically clears after 5 seconds.
References and Troubleshooting WARNING: • A hazard can exist if different alarm styles are used on multiple pumps in the same single care area, for example, a critical care area or operating room. Auditory alarm signal sound levels that are less than ambient levels can hinder operator recognition of alarm conditions. • Always set the Delivery Limit amount alarm, Reservoir Volume Low alarm, and all other variable alarm settings to clinically appropriate settings.
References and Troubleshooting Note: Refer to the instructions for use for each accessory before proceeding with cleaning. For optimal efficiency, it is recommended best practice to clean first and then disinfect. All disinfectants require pre-cleaning, except for disinfectant cleaners that are tested to disinfect in the presence of 5% of organic matter. 1. Inspect the Downstream Occlusion (DSO) seal for damage or wear to the rubber material during cleaning and at each preventative maintenance service.
References and Troubleshooting PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges Units Starting Value Increment Max. Milliliters 0 0.05 50 PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Milligrams Concentration (mg/mL) 0.1 Increment (mg) 0.01 Max. (mg) 5 Concentration (mg/mL) 20 Increment (mg) 1.00 Max. (mg) 1000 0.2 0.02 10 25 1.25 1250 0.3 0.03 15 30 1.50 1500 0.4 0.04 20 35 1.75 1750 0.5 0.05 25 40 2.00 2000 1 0.05 50 45 2.
References and Troubleshooting PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Micrograms References and Troubleshooting Concentration (mcg/mL) 1 68 Increment (mcg) 0.05 Max. (mcg) 50 Concentration (mcg/mL) 35 Increment (mcg) 1.75 Max. (mcg) 1750 2 0.10 100 40 2.00 2000 3 0.15 150 45 2.25 2250 4 0.20 200 50 2.50 2500 5 0.25 250 55 2.75 2750 6 0.30 300 60 3.00 3000 7 0.35 350 65 3.25 3250 8 0.40 400 70 3.50 3500 9 0.45 450 75 3.
References and Troubleshooting Technical Description Standards used in development of the pump The following standards were used in whole or part in the development of the pump. Medical Electrical Equipment: EN 60601-1 (2006 + A1:2013 + A11:2011 + A12:2014) Ed3.1, Medical Electrical Equipment, Part I: General Requirements for Safety. Amendment A1 (1993) Amendment A13 (1996) Amendment A2 (1995).
References and Troubleshooting Specifications (Nominal) General Pump Specifications System definition CADD®-Solis pump with 1 of the following attached: • Medication cassette reservoir and CADD® extension set • Medication cassette reservoir with Flow Stop feature and CADD® extension set • CADD® administration set • CADD® administration set with Flow Stop feature Classification CF J Class II K Used to test the pump • • • • • • • Resolution CADD™ medication cassette reservoirs, < 21-7002 and < 21-7309
References and Troubleshooting Battery status Battery State 25% to 100% No alarm Low battery • • • • • • • • • • • • Depleted battery Shut down Alkaline battery life with screen backlight intensity set to 3 CADD®-Solis Pump Status Transition to low battery condition Battery low message appears Pump emits 3 beeps every 5 min Low battery warning message appears on pump display Pump is operable LCD backlight flashes for 12 ms during each motor operation Transition to depleted battery condition Battery d
References and Troubleshooting Rechargeable battery pack life with screen backlight intensity set to 3 These estimates are based on laboratory tests conducted at room temperature using a new CADD®-Solis rechargeable battery pack. Actual battery life varies depending on the temperature conditions, delivery rate, and frequency of screen display and backlighting. It is recommended that new batteries be kept available for replacement.
References and Troubleshooting Maximum time to occlusion alarm and Maximum Bolus volume at occlusion alarm The pressure build-up that occurs after an occlusion may cause fluid to accumulate or be stored in the line. This extra fluid may be delivered as a bolus when the occlusion is released. For corrective action, see the steps listed under “Downstream occlusion” in the Alarms and Messages, Alphabetical List on page 58. Flow Rate Tubing Set Max. Time to Occlusion Max. Bolus at Occlusion Spec.
References and Troubleshooting System Delivery Accuracy ± 6% at nominal (at 90/90 tolerance level). At low infusion rates, stated accuracy may not be achieved for short periods. During the total infusion time, the accuracy averages out. System delivery accuracy is determined under the following nominal conditions: • Infusion rate of 10mL/hr • Ambient temperature of 22 degree C • Fluid viscosity of 0.89 cP (i.e., water) • 0.2 mmHg (0.004 PSI) back pressure (i.e.
References and Troubleshooting Patient Selection It is important to consider patient selection with regard to clinical factors and environmental factors. These factors can include the route of administration, the prescribed medication, and the system configuration chosen to ensure acceptable delivery accuracy is appropriate for your patient. Consideration of Continuous Flow at Low Rates Delivery accuracy is not tested below 10 mL/hr.
References and Troubleshooting Delivery Specifications Programming units • Milliliters (mL) • Milligrams (mg) • Micrograms (mcg) Concentration Reservoir volume Given Delivery limit amount Continuous rate Clinician bolus PCA dose PCA dose lockout References and Troubleshooting Intermittent bolus Intermittent bolus interval Next bolus Maximum doses per hour mg/mL: • 0.1 to 0.5 mg/mL in increments of 0.1 mg/mL • 0.5 to 1 mg/mL in increments of 0.
References and Troubleshooting Administrator Settings Specifications KVO rate • 0 mL/hr if continuous rate is 0 mL/hr • 0.1 mL/hr if continuous rate > 0 mL/hr, with standard administration set • 0.2 mL/hr if continuous rate > 0 mL/hr, with high volume administration set Bolus interval type • Bolus interval • PCA lockout Maximum delivery • With standard administration set: 250 mL/hr rate (PCA dose, • With high volume administration set: 500 mL/hr clinician bolus, • Max.
References and Troubleshooting Electromagnetic Emissions and Immunity Declarations Guidance and Manufacturer’s Declaration—Electromagnetic Emissions The CADD®-Solis pump is intended for use in the electromagnetic environment specified below. The customer or the user of the CADD®-Solis pump should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment—Guidance RF emissions CISPR 11 Group 1 The Pump uses RF energy only for its internal function.
References and Troubleshooting Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The CADD®-Solis pump is intended for use in the electromagnetic environment specified below. The customer or user of the CADD®-Solis pump should assure that it is used in such an environment.
References and Troubleshooting Recommended separation distances between portable and mobile RF communications equipment and the CADD®-Solis pump The CADD®-Solis pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
References and Troubleshooting Programming Screens/Menus Maps Patient Specific Parameters and/or Home Screen Continuous Rate* Intermittent Bolus* Bolus Interval* Reports Intermittent Bolus Status Given and PCA† Dose Counters PCA† Dose Graph Intermittent Bolus Graph Next Bolus* PCEA† and Intermittent Graph PCA† Dose* PCA† Lockout* Hourly Limit* Max Doses / Hour* Reservoir Vol.
References and Troubleshooting Default Factory Settings The first time you use the pump, the protocol is set to the factory default. You may reset the pump to the factory default at any time. Refer to the Administrator Settings Guide for more information on how to reset the pump to the factory default. The factory default is a manual mode programming, see page 51.
References and Troubleshooting Accuracy Test Results In this device, as with all infusion pumps, the motion of the pumping mechanism and variations in individual disposables cause short-term fluctuations in rate accuracy. The following curves show typical performance of the pump system in two ways: 1. A flow versus time graph during the stabilization period (start-up curves). 2. The accuracy of fluid delivery of particular time periods or ‘observation windows’ is measured (trumpet curves).
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Index Index A AC adapter 17 Alarms and messages 58, 61, 62 Battery backup 16, 20 CADD-Solis Communication Module 17 Power jack 16 Rechargeable battery pack 17 Symbols 13, 23 Accessories 17 Accuracy Bolus accuracy specification 75 System delivery 74 Test results 83 Adjust admin settings 38 Adjust alarm volume 37 Adjust backlight intensity 36 Administrator (admin) code 28 Admin settings 38 See also Administrator Settings Guide Air detector 34, 65 Alarms and messages 55, 72 Alphabetical list 58 Amber indicato
Index F Factory settings 82 G Medium priority alarms 55 Menu maps 81 Messages See Informational messages Help screens 56 MRI exposure 65 Give clinician bolus 31 Given and PCA dose counters 39 H Hard limits 45, 51 Hardware version 44 Help Screens 56 High priority alarms 55, 73 Home screen Symbols 13 Hourly limit 49 I Indications 9 Indicator lights See Lights Informational messages 56, 58 Intermittent bolus 10, 46, 77 Bolus interval 46, 77 Intermittent bolus graph 41 Intermittent bolus status 39 Next bo
Index R Radiation exposure 65 Rechargeable battery pack 17 AC adapter 17 Alarms and messages 59, 61, 63 Battery life 73 Installing 21 Symbols 13, 23 Recycling the pump 80 Remote dose cord 18 Alarms and messages 62 PCA dose delivery 48 Remote dose cord jack 12, 14, 16 Reports 37, 39 Current profile / protocol 42 Daylight saving time 43 Delivery history and pie chart 41 Delivery log 42 Device information 44 Event log 43 Given and PCA dose counters 39 Intermittent bolus graph 41 Intermittent bolus status 39 P
Manufacturer: Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA Tel: 1 800 258 5361 (USA/CA) Tel: +1 614 210 7300 European Representative: Smiths Medical Czech Republic a.s. Olomoucká 306, Hranice 1 - Město, 753 01 Hranice, Czech Republic Tel: +44 (0) 1233 722100 www.smiths-medical.com CADD-Solis, CADD, the CADD design mark, and the Smiths Medical design mark are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S.
