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 ®...
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• 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. • To avoid patient injury and electric shock, remove the pump from patient use prior to any preventative maintenance and servicing of the pump.
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• 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.
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• Serious harm to the patient or operator may result from the use of modified parts or parts not authorized by Smiths Medical. Do not modify the system, parts, or accessories. • 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.
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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, as other brands may adversely affect pump operation. •...
Administration of any drug by this pump is limited by any warnings, precautions, or contraindications in the drug labeling. Smiths Medical has performed neurotoxicological testing using 0.9% saline to represent aqueous drugs infused into epidural and subarachnoid spaces.
eneral escription 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.
CADD -Solis pump. Note: Smiths Medical does not recommend mixing new and used AA batteries because it may affect low battery alarm times. Always use four new batteries when replacing depleted ones.
etuP 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.
etuP 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®...
rogramming and Peration 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.
rogramming and Peration 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.
rogramming and Peration 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...
rogramming and Peration 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...
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rogramming and Peration Manual Mode Initial Settings 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 Continuous Rate Limits Range is 0–100 mL/hour (or mg or mcg equivalent).
rogramming and Peration 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).
If this screen appears, an unrecoverable error may have occurred, such as a hardware or software fault. The amber indicator light is continuously illuminated during these conditions and is accompanied by an audible two-tone alarm. If a system fault occurs, the fault should be reported to Customer Service at Smiths Medical or Smiths Medical International Ltd.
efeRences and RoubleshooTing Alarms and Messages, Alphabetical List Alarms and Alarm Description / Corrective Action Messages Priority (Screen is blank High The pump was delivering and the batteries or the CADD®-Solis and alarm is Communication Module with integrated rechargeable battery sounding) was removed, the battery door was opened, or the batteries are too depleated to power the pump.
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efeRences and RoubleshooTing Alarms and Alarm Description / Corrective Action Messages Priority Battery removed. High The rechargeable battery pack, CADD®-Solis Communication Pump stopped. 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.
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If the alarm persists after trying the above, the pump’s pressure sensor is faulty. Remove the pump from service and contact Smiths Medical Customer Service. Current settings High...
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2 mL. Select Acknowledge to clear the alarm. If this alarm occurs regularly, the pump may be faulty. Remove the pump from use and contact Smiths Medical Customer Service. Depleted battery is The rechargeable battery pack or the CADD®-Solis Communication charging.
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PCA remote dose cord button. If the alarm persists, remove the cord. PCA remote dose cord to clear the alarm and contact Smiths Medical Customer Service. You may continue using the pump with another PCA remote dose cord, or using the PCA (PCEA) dose @ button on the pump.
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efeRences and RoubleshooTing Alarms and Alarm Description / Corrective Action Messages Priority Protocol library Medium A new or updated library is currently being downloaded into the updating. pump. You cannot select any new protocols while this update is in process. Select Acknowledge to clear the alarm or it will Reselect protocol when update is automatically clear when the update is complete.
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Down to power down the pump. Service personnel shall attempt to pump. re-install the CADD®-Solis Communication Module and power the pump back up. If the alarm persists, install another communication module or contact Smiths Medical Customer Service to return the pump for service.
efeRences and RoubleshooTing 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.
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1. Inspect the Downstream Occlusion (DSO) seal for damage or wear to the rubber material during cleaning and at each preventative maintenance service. DSO seals that show signs of cracking or abrasion(s) should be returned to a Smiths Medical Service Center for replacement of the DSO seal, sensor, and bezel.
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efeRences and RoubleshooTing PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges Units Starting Value Increment Max. Milliliters 0.05 PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Milligrams Concentration Increment Max. Concentration Increment Max. (mg/mL) (mg) (mg) (mg/mL) (mg) (mg) 0.01 1.00...
efeRences and RoubleshooTing 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.
efeRences and RoubleshooTing 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 •...
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efeRences and RoubleshooTing Battery status Battery State CADD®-Solis Pump Status 25% to 100% No alarm • Low battery Transition to low battery condition • Battery low message appears • Pump emits 3 beeps every 5 min • Low battery warning message appears on pump display •...
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efeRences and RoubleshooTing Rechargeable These estimates are based on laboratory tests conducted at room temperature battery pack using a new CADD®-Solis rechargeable battery pack. Actual battery life varies life with screen depending on the temperature conditions, delivery rate, and frequency of backlight intensity screen display and backlighting.
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efeRences and RoubleshooTing Maximum time to The pressure build-up that occurs after an occlusion may cause fluid to occlusion alarm 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”...
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efeRences and RoubleshooTing System Delivery ± 6% at nominal (at 90/90 tolerance level). Accuracy 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: •...
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efeRences and RoubleshooTing 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.
efeRences and RoubleshooTing Delivery Specifications • Programming units Milliliters (mL) • Milligrams (mg) • Micrograms (mcg) Concentration mg/mL: • 0.1 to 0.5 mg/mL in increments of 0.1 mg/mL • 0.5 to 1 mg/mL in increments of 0.5 mg/mL • 1 to 15 mg/mL in increments of 1 mg/mL •...
efeRences and RoubleshooTing 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 •...
efeRences and RoubleshooTing 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...
efeRences and RoubleshooTing 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.
efeRences and RoubleshooTing 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.
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ndex Index CADD-Solis Communication Module 17, 20, 21, 44 AC adapter 17 CADD-Solis Network Setup Utility 19 Alarms and messages 58, 61, 62 Cassettes 14, 18 Battery backup 16, 20 CADD-Solis Communication Module 17 Alarms and messages 60, 61, 62, 63, 64 Power jack 16 Attaching a cassette 25 Rechargeable battery pack 17...
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ndex Medium priority alarms 55 Menu maps 81 Factory settings 82 Messages See Informational messages Help screens 56 MRI exposure 65 Give clinician bolus 31 Given and PCA dose counters 39 New patient 32 New protocol, same patient 33 Next bolus 10, 11, 47, 76 Hard limits 45, 51 Hardware version 44 Help...
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ndex Tasks 31 Radiation exposure 65 Adjust admin settings 38 Rechargeable battery pack 17 Adjust alarm volume 37 AC adapter 17 Adjust backlight intensity 36 Alarms and messages 59, 61, 63 Give clinician bolus 31 Battery life 73 Prime tubing 34 Installing 21 Set time and date 34 Symbols 13, 23...
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