ICU Medical CADD-Solis

Asset Type

Infusion Pump

Manufacturer

ICU Medical

Model

CADD-Solis

Manual Reference

CADD-Solis 2100/2110 Technical Manual, Pump Software Version 3.0, Smiths Medical, 2013-12.

Manufacturer Recommendation / AEM Status

This is a usable PM manual. The technical manual includes a manufacturer-listed Annual Inspection and Testing Procedures section. Smiths Medical recommends the inspection and test procedures be performed annually to verify function and accuracy of the CADD-Solis pump.

Manufacturer-listed PM / inspection items include:

• Visual inspection
• Mechanical inspection
• Functional testing
• Occlusion pressure range testing
• Accuracy testing
• Pump cleaning and functional testing checklist
• Cleaning and disinfecting after each patient use, in accordance with the manual and facility policy
• Battery inspection / replacement when damaged, depleted, or worn
• Rechargeable battery pack inspection for damage or wear
• Air detector sensor slot inspection and debris removal
• Pressure plate / pumping mechanism surface inspection for debris

Manufacturer-listed frequency:

• Annual: inspection and test procedures to verify function and accuracy
• After each patient use: clean and disinfect pump and reusable accessories
• Battery replacement: as needed when depleted, damaged, worn, or unusable
• Rechargeable battery pack: discontinue use if damaged or worn
• PM reminder setting: configurable from 1 to 24 months, but this is a setting range, not the annual PM recommendation itself

Important service limitation: The manual states that all servicing and repair of the CADD-Solis ambulatory infusion pump must be performed by Smiths Medical or its authorized agents. A broken or damaged seal is considered evidence that the pump has been misused and/or altered, and all service/repair must be performed by Smiths Medical or authorized agents.

AEM note: If a facility performs this PM at a different interval or changes the listed activities, that should be handled under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

• Annual visual, mechanical, functional, occlusion, and accuracy checks
• Battery compartment and power-up inspection
• Cassette latch, lock, and sensor verification
• Motor, alarm, air detector, remote dose cord, and battery fallout checks
• Downstream and upstream occlusion testing
• Accuracy testing using either gravimetric or volumetric method
• Electrical safety documentation considerations

Required Tools and Equipment

Manual-supported tools and supplies include:

• 4 AA batteries
• CADD key
• CADD medication cassette reservoir and/or CADD administration set
• Primed CADD medication cassette reservoir with fluid and CADD extension set with anti-siphon valve, or primed CADD administration set with anti-siphon valve
• Timer
• CADD-Solis remote dose cord
• Distilled water or room temperature water
• Tubing clamp, slide clamp, or hemostat
• Pressure gauge, 30 psi ± 1 psi, if using downstream occlusion pressure range test 2
• Pressure vessel partially filled with water, if using downstream occlusion pressure range test 2
• Pressure regulator, 30 psi, if using downstream occlusion pressure range test 2
• Safety glasses, if using downstream occlusion pressure range test 2
• Balance accurate to 0.1 g, if using gravimetric accuracy test
• 50 mL or 60 mL syringe
• Fluid collection device, burette, or Class A 25 mL graduated cylinder, if using volumetric accuracy test

Step-by-Step PM Procedure

1. Confirm Device Status and Remove From Patient Use

Action: Confirm the pump is not connected to a patient. Remove any medication cassette, administration set, or patient-use accessory per facility policy.

Expected outcome: Pump is safe to inspect and test.

Why it matters: This is an infusion pump. PM testing involves simulated delivery, priming, alarms, occlusion checks, and possible fluid handling.

2. Clean and Inspect External Surfaces

Action: Clean the pump with a mild detergent solution applied to a soft, lint-free cloth. Disinfect using a manual-supported disinfectant and allow the pump to dry completely before use.

Expected outcome: Pump is clean, dry, and free of residue.

Do not: Immerse the pump, oversaturate the keypad/chassis, allow liquid into the battery compartment, USB port, remote dose jack, or power jack, or use acetone, plastic solvents, or abrasive cleaners.

3. Perform Visual Inspection

Action: Inspect the following:

• LCD
• Occlusion sensor seals
• Valves and expulsor
• Cassette hinge area
• Latch handle
• USB connector
• Lock
• Cassette sensors
• Keypad
• Indicator lights
• AC power jack
• Remote dose jack
• Air detector sensor
• Pump housing
• Battery door and battery door seal
• Battery compartment for damage, fluid, or debris

Expected outcome: No damage, contamination, cracked parts, loose parts, blocked sensors, or abnormal wear.

Remove from service if: Housing is damaged, seal is broken, battery compartment is contaminated, sensors are damaged, display is faulty, or pump appears damaged from a drop or impact.

4. Perform Mechanical Inspection

Action: Press each keypad button and verify a distinct tactile feel. Close and latch the battery door. Attach a CADD medication cassette reservoir or CADD administration set and verify smooth latch operation. Gently twist and pull on the cassette to confirm secure attachment. Lock the cassette using the CADD key.

Expected outcome: Keypad feels normal, battery door fits snugly, cassette latches smoothly, cassette remains attached, and lock functions normally.

5. Power-Up and LCD Check

Action: Install 4 AA batteries and power on the pump. Observe the display during startup.

Expected outcome: Display flashes through the expected startup screens, no abnormal pixels/stripes are seen, six audible beeps occur, and no system fault appears.

Remove from service if: System fault screen appears and repeats, LCD is defective, or pump does not complete startup normally.

6. Latch, Lock, and Cassette Sensor Checks

Action: Attach, latch, lock, unlock, and remove the cassette/admin set as described in the manual.

Expected outcome: Pump displays the expected latch, lock, unlock, and removal status messages.

Remove from service if: Cassette detection, latch detection, or lock detection fails.

7. Motor and Reservoir Volume Zero Check

Action: Program the pump per the manual’s annual functional test setup. Use the listed reservoir volume and delivery settings to verify motor operation and reservoir zero alarm behavior.

Expected outcome: Pump primes/delivers as expected, motor does not grind or sound abnormal, reservoir volume reaches zero, and the pump displays the reservoir volume zero / pump stopped message.

8. Stop/Start Pump and LED Indicator Test

Action: Start and stop the pump following the manual sequence.

Expected outcome: Pump starts, status bar shows running, green LED blinks during running status, alarm behavior occurs as expected, pump stops, amber LED blinks, and status bar shows stopped.

9. Activation Timing Check

Action: Run the manual-listed activation timing check.

Expected outcome: One activation occurs every 12 seconds. After approximately 1 minute 50 seconds and 10 activations, the reservoir empty alarm occurs.

10. Remote Dose Cord Check

Action: Attach the remote dose cord and program the pump using the manual-listed PCA test parameters.

Expected outcome: Remote dose button initiates delivery when available. Pump performs 10 double activations for a 1 mL PCA dose, reservoir volume decreases appropriately, and additional attempts during lockout are denied with the lockout message.

11. Doses Given and Doses Attempted Check

Action: View and clear the Given and PCA Dose Counters report as described in the manual.

Expected outcome: Total Given, PCA Doses Given, and PCA Doses Attempted match expected values after the remote dose cord check, then clear to zero.

12. Air Detector Test

Action: Turn the air detector on. Test with an empty cassette/admin set, then test again with a primed fluid path containing no air.

Expected outcome: Pump alarms and prevents start with air in line. Pump delivers without air detection alarm when the fluid path is properly primed and free of air.

13. Battery Fallout Alarm Test

Action: Run the pump for at least 4 minutes, then open the battery door while timing the alarm.

Expected outcome: Pump sounds a continuous two-tone alarm for at least 2 minutes.

14. Audible Alarm Check

Action: Verify low, medium, and high alarm volume settings.

Expected outcome: Pump sounds each alarm volume when selected.

15. Occlusion Pressure Range Testing

Action: Perform either downstream occlusion pressure range test 1 or downstream occlusion pressure range test 2. Do not perform both unless facility policy requires it.

Downstream Test 1 expected outcome: Pump alarms when it delivers between 1 and 2 activations against the clamped cassette reservoir tubing.

Downstream Test 2 expected outcome: High pressure alarm sounds between 9 psi and 27 psi.

Safety note: For downstream test 2, reduce pressure to zero before detaching the cassette. Safety glasses should be worn.

Upstream occlusion expected outcome: With the upstream occlusion sensor turned on, pump alarms within 3 activations after tubing is clamped.

16. Accuracy Testing

Action: Perform either the gravimetric accuracy test or the volumetric accuracy test. Do not perform both unless facility policy requires it.

Expected outcome: Accuracy error percentage is within ±6%.

If failed: Repeat the test with a new CADD medication cassette reservoir. If the pump fails a second time, call Smiths Medical.

Electrical Safety Testing

The manual identifies the pump as Class II and CF classification. The annual inspection and testing section does not list a protective earth/ground resistance test or a leakage current PM test procedure for the pump.

Because this is Class II equipment, protective earth ground resistance is generally not applicable unless facility policy has a specific reason to document it.

Ground resistance:
Not applicable for Class II equipment unless facility policy requires otherwise.
Result = N/A / Tested per facility policy =

Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =

Do not invent a leakage limit from this manual. Use facility policy, test equipment settings, and applicable electrical safety program criteria.

Pass / Fail Criteria

Pass PM if:

• Visual inspection passes
• Mechanical inspection passes
• Power-up and LCD check pass
• Latch, lock, cassette sensor, and keypad checks pass
• Motor, reservoir zero alarm, start/stop, LED, activation timing, remote dose cord, dose counter, air detector, battery fallout alarm, and audible alarm checks pass
• Occlusion pressure test passes
• Accuracy test is within ±6%
• No repeated system fault occurs
• Pump is clean, dry, intact, and safe for use

Remove from service if:

• Pump is damaged or not functioning properly
• System fault repeats
• Protocol library lost message appears
• Seal is broken or damaged
• Battery compartment has fluid/debris damage
• Display, keypad, latch, lock, cassette sensors, air detector, occlusion sensors, or alarms fail
• Downstream or upstream occlusion test fails
• Accuracy test fails twice
• Pump requires repair beyond facility-approved inspection/testing

Optional Short Procedure Blocks

Scheduled PM

Completed annual PM on ICU Medical CADD-Solis infusion pump per manufacturer-listed annual inspection and testing procedure. Visual, mechanical, functional, occlusion, alarm, air detector, remote dose cord, battery fallout, and accuracy checks completed. Accuracy result within ±6%: Result =. Final status: Returned to service / Removed from service =.

Cleaning / Disinfection Only

Cleaned and disinfected ICU Medical CADD-Solis pump per manual-supported cleaning guidance and facility policy. Pump was not immersed or oversaturated. Battery compartment, ports, keypad, air detector area, and pump housing inspected. Pump allowed to dry completely before return to use. Final status: Returned to service / Removed from service =.

Failed PM / Remove From Service

ICU Medical CADD-Solis pump failed PM inspection/testing. Failed item(s): ____. Pump removed from service. Per technical manual, service/repair is to be performed by Smiths Medical or authorized agents. Final status: Removed from service.

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.