Smiths Medical CADD 2120 Technical Manual
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Smiths Medical CADD 2120 Technical Manual

Solis vip ambulatory infusion pump
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CADD®-Solis VIP
Ambulatory Infusion Pump
Technical Manual
Model 2120
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Summary of Contents for Smiths Medical CADD 2120

  • Page 1 ® CADD®-Solis VIP Ambulatory Infusion Pump Technical Manual Model 2120...

  • Page 2: Technical Assistance

    The issue date of this Technical 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 revision of this manual is available.

  • Page 3: Table Of Contents

    Table of Contents Hardware and Software Fault Detection 25 Technical Assistance ......2 System Fault Alarm ......25 Introduction .

  • Page 4: Introduction

    ® CADD product line are believed to be accurate and reliable, but do not constitute warranties. No agent, representative, or employee of Smiths Medical has authority to bind Smiths Medical to any representation or warranty, expressed or implied. Warnings •...

  • Page 5: Cautions

    All ® service and repair of CADD pumps must be performed by Smiths Medical or its authorized agents. • At the completion of the Downstream Occlusion Pressure Range Test 2, the pressure must be reduced to zero before detaching the cassette from the pump;...

  • Page 6: Pump Overview

    vervIew Pump Overview Delivery Modes ® The CADD -Solis VIP ambulatory infusion pump system provides measured drug therapy to patients ® in hospital or outpatient settings. The CADD -Solis VIP 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.

  • Page 7: Intermittent Delivery Profile

    vervIew Intermittent Delivery Profile Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval. Cycle Delayed start (optional) Duration Duration Dose Dose Time Step Delivery Profile Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

  • Page 8: Pump Diagram

    vervIew 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 Serial (Unlock/Lock) number Cassette Latch Cassette (The part of the CADD™ medication cassette reservoir or CADD®...

  • Page 9: Pca Delivery Mode Scroll Ranges

    vervIew PCA Delivery Mode Scroll Ranges PCA Continuous Rate Scroll Ranges Units Starting Value Increment Maximum 0.10 100.00 Milliliters 0.01 Concentration x 100 Milligrams 10% of Values between 0.01 and 0.5: only concentration Micrograms 10% of Values between 0.1 and 0.5: Concentration x 100 only concentration...
  • Page 10 vervIew PCA Dose and Clinician Bolus Scroll Ranges: Micrograms Concentration Increment Max. Concentration Increment Max. (mcg/mL) (mcg) (mcg) (mcg/mL) (mcg) (mcg) 0.05 1.75 1750 0.10 2.00 2000 0.15 2.25 2250 0.20 2.50 2500 0.25 2.75 2750 0.30 3.00 3000 0.35 3.25 3250 0.40...

  • Page 11: Specifications (Nominal)

    vervIew Specifications (Nominal) General Pump Specifications Used to test the ™ • medication cassette reservoirs, < 21-7002, 21-7308, 21-7302 CADD ® pump • extension sets, < 21-7045, 21-7046, 21-7047 CADD ® • administration sets, < 21-7091, 21-7034, 21-7021, 21-7321 CADD ®...
  • Page 12 vervIew Maximum time to Max. Time to Bolus at occlusion alarm Occlusion Occlusion Flow and Bolus volume Rate Tubing Set at occlusion alarm Spec. Spec. Test Test (mL/hr) Data Data (min) (mL) (min) (mL) CADD™ medication cassette reservoir < 21-7002 with ≤...
  • Page 13 vervIew System delivery ± 6% (nominal). At low infusion rates, this accuracy may not be achieved for short periods. During the total infusion time, the accuracy averages out. accuracy WARNING: • Ensure that the ± 6% system delivery accuracy specification is taken into account when programming the pump and/or filling the reservoir.

  • Page 14: Delivery Specifications

    vervIew • Delivery rate Standard volume administration set: approx. 250 mL/hr • High volume administration set: approx. 500 mL/hr during priming Alarm disabled Air-In Line during priming Delivery Specifications Common Delivery Specifications Reservoir volume 0 to 9999 Programmable in 1 mL increments. Displayed in 0.1 mL increments.
  • Page 15 vervIew Common Delivery Specifications • Upstream • occlusion sensor Note: The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs. PCA Delivery Specifications Programming units If programming through manual mode. Otherwise the programming units are ™ preset through the CADD -Solis Medication Safety Software.

  • Page 16: Remote Dose Cord

    Remote Dose Cord Smiths Medical provides a remote dose cord for use by the patient. The push button is a single pole double throw (SPDT) switch. When the remote dose cord is attached to the pump, the patient may press the remote dose cord button to receive a PCA dose.

  • Page 17: Batteries

    -Solis VIP ambulatory infusion pump. Note: Smiths Medical does not recommend mixing new and used batteries; doing so may affect low battery alarm times. Always select four new batteries when replacing depleted batteries. 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.
  • Page 18 atterIes ® The following tables may be used to predict typical alkaline battery and CADD -Solis rechargeable battery pack life at different delivery rates. As expected, battery life decreases as the delivery rate increases. Alkaline battery These estimates are based on laboratory tests conducted at room temperature ®...
  • Page 19 atterIes Rechargeable These estimates are based on laboratory tests conducted at room temperature ® using a new CADD -Solis rechargeable battery pack. Actual battery life varies battery pack depending on temperature conditions, delivery rate, and frequency of screen life with screen display and backlighting.

  • Page 20: Collect Separately

    atterIes Collect Separately This product contains electrical and electronic components (including batteries) that may contain materials, which if disposed of with general waste, could be damaging to the environment. In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, residents of the European Union must follow specific disposal or recycling instructions for this product.

  • Page 21: Construction

    onstructIon Construction The pump housing is made of special, high-impact plastic with an internal metallized coating designed to reduce interference from electromagnetic fields and dissipate electrostatic discharge. It is composed of 3 sections: the base, cover, and battery housing. The pump housing is sealed to ensure that the pump is water resistant.

  • Page 22: Pumping Operation

    umPIng PeratIon Pumping Operation Battery Backed RAM The delivery and recordkeeping parameters for the pump are stored in a battery-backed random access memory (RAM). Battery backup is provided by a lithium manganese dioxide rechargeable battery. This battery is designed to provide a minimum of 10 months of backup power to the memory when the pump is turned off.

  • Page 23: Battery Status

    umPIng PeratIon Battery Status Battery State CADD®-Solis VIP Pump Status 25% to 100% No alarm • Low battery Transition to low battery condition • Battery low message appears • Pump emits 3 beeps every 5 minutes • Low battery warning message appears on pump display •...

  • Page 24: Pumping Characteristics

    umPIng PeratIon When the microprocessor commands the mechanism to pump, the camshaft begins to rotate, thus controlling the following pump cycle: 1. The inlet valve closes. 2. In synchrony with the expulsor moving down to compress the tubing, the outlet valve opens, expelling fluid.

  • Page 25: Hardware And Software Fault Detection

    AC power. Close the battery door and turn the pump back on. If the error code does not repeat, Smiths Medical Customer Service may suggest continued use of the pump. If the error is persistent, the pump must be returned for service.

  • Page 26: Cleaning Procedures

    leanIng Cleaning Procedures Cleaning Solutions The following solutions may be used to clean the pump and accessories, unless otherwise specified: • • Soap solution Chlorhexidine gluconate (4%) ® • • Benzalkonium chloride concentrate (0.13%) PDI Super Sani-Cloth • • Glutaral concentrate, USP (2%) Madacide (MADA Medical) •...

  • Page 27: Annual Inspection And Testing Procedures

    CAUTION: 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.

  • Page 28: Iii. Functional Testing

    nnual nsPectIon and estIng III. Functional Testing ☐ Power Up Check / LCD Check Equipment needed 4 AA batteries Procedure Insert 4 AA batteries into the pump. Press and hold the power on/off switch. Observe the LCD during power up. The display should quickly flash gray, then blue. An amber ®...
  • Page 29 nnual nsPectIon and estIng ☐ Motor and “Reservoir Volume is Zero” Alarm Checks Note: Conduct the Motor and “Reservoir Volume is Zero” Alarm check, and Stopping/Starting the Pump and LED Indicator tests in sequence, as shown below. Equipment needed ™ ®...
  • Page 30 nnual nsPectIon and estIng 12. “Infusion is starting now…” should appear on the screen. 13. The main screen should appear with “Running” in the status bar, and the green LED indicator light should blink every 3 seconds. Note: When the display is blank, the green, amber, or both LED indicators periodically flash to indicate power and running status.
  • Page 31 nnual nsPectIon and estIng ☐ Doses Given and Doses Attempted Check 36. Stop the pump by pressing stop/start , then select Yes. From the View Reports menu, select Given and PCA Dose Counters. 38. The display should show “Total Given 1 mL” and “PCA Doses Given 1, PCA Doses Attempted 3.”...
  • Page 32 nnual nsPectIon and estIng ☐ Battery Fallout Alarm Test Equipment needed ™ medication cassette reservoir or • 1 CADD ® 1 CADD administration set • 1 CADD® key • Timer Procedure Program the continuous rate to 1.0 mL/hr. From the Tasks menu, select View Advanced Tasks, and then select Air and Occlusion Settings.

  • Page 33: Iv. Occlusion Pressure Range Tests

    nnual nsPectIon and estIng IV. Occlusion Pressure Range Tests Downstream occlusion and upstream occlusion use stored constants for offset and gain to maintain occlusion accuracy. Note: Perform either downstream test 1 or test 2, but not both. ☐ Downstream Occlusion Pressure Range Test 1 Description: ™...
  • Page 34 nnual nsPectIon and estIng Assemble the apparatus as shown. 30 psi Regulator Pressure Gauge ™ Connect the CADD medication cassette reservoir outlet tube to the metered pressure source. Program the pump to deliver a continuous rate of 30 mL/hr. Start the pump. Slowly increase the back pressure, noting when the high pressure alarm is activated.

  • Page 35: Accuracy Tests

    nnual nsPectIon and estIng V. Accuracy Tests Calibration is not required in order to maintain delivery accuracy. The pump does not require the use of stored calibration values in order to achieve or maintain delivery accuracy. Note: Perform either the gravimetric test or the volumetric test, but not both. ☐...
  • Page 36 ™ 18. If the accuracy error percentage is greater than ± 6%, repeat the test with a new CADD medication cassette reservoir. If the pump fails a second time, call Smiths Medical. Example Pre-delivery Weight 61.1 g Post-delivery Weight –...
  • Page 37 Divide the inaccuracy volume by the intended delivery volume and multiply by 100. This is the accuracy error percentage. ™ 15. If the accuracy error percentage is greater than ± 6%, repeat the test with a new CADD medication cassette reservoir. If the pump fails a second time, call Smiths Medical.
  • Page 38 nnual nsPectIon and estIng Example Actual Delivery Volume 19.5 mL Intended Delivery Volume – 20.0 mL = – 0.5 mL Inaccuracy Volume Inaccuracy Volume – 0.5 mL Intended Delivery Volume ÷ 20.0 mL Accuracy Error = – 0.025 Accuracy Error –...

  • Page 39: Pump Cleaning And Functional Testing

    hecklIst Pump Cleaning and Functional Testing Checklist The following checklist is only a guide to assist in establishing documentation of cleaning and functional ® testing for the CADD -Solis VIP pump. The procedures are described in this Technical Manual. If service is required, fill out a copy of this page and return it with the device.
  • Page 40 61 Brandl Street Eight Mile Plains, QLD 4113, Australia +61 (0) 7 3340 1300 CADD-Solis, CADD, and the CADD and Smiths Medical design marks are trademarks of Smiths Medical. ® The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries.

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