Smiths Medical CADD Solis 2100 Technical Manual Download Page 38

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Annual Inspection and Testing

Example:

Actual Delivery Volume

19.5 mL

Intended Delivery Volume

– 20.0 mL

Inaccuracy Volume

= – 0.5 mL

Inaccuracy Volume

– 0.5 mL

Intended Delivery Volume

÷ 20.0 mL

Accuracy Error

= – 0.025

Accuracy Error

– 0.025

× 100.00

Accuracy Error Percentage

= – 2.5%

Summary of Contents for CADD Solis 2100

Page 1: ...2100 2110 Pump software version 3 0 X s ...

Page 2: ...tor Settings Guide supplied with the product Smiths Medical is available to help with the programming and operation of the CADD Solis ambulatory infusion pump If you have comments or questions call the number given below When calling specify the pump s software version number This information is located in the Device Information Report see the Reports section in the CADD Solis Operator s Manual fo...

Page 3: ...age 18 Battery Life 18 Battery Status 20 Collect Separately 20 Construction 21 Pumping Operation 22 Battery Backed RAM 22 LCD Circuitry 22 LED Status Indicators 22 Audible Alarm Circuitry 22 Power Circuitry 22 Pumping Mechanism 23 Pumping Characteristics 24 Cassette Type Sensor Circuit 24 Latch Lock Sensor Circuit 24 Hardware and Software Fault Detection 25 System Fault Alarm 25 Order of System Fa...

Page 4: ...ticular medical treatment or for any medical complications resulting from the use of the system The manufacturer shall not be responsible for any incidental damages or consequential damages to property loss of profits or loss of use caused by any defect or malfunction of the system If you wish to receive additional information about the extent of the warranty on these products please contact your ...

Page 5: ... 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 Do not store the pump for prolonged periods with the batteries installed Battery leakage could damage the pump Do not twist or turn the remote dose cord connector or...

Page 6: ...infusion and or an intermittent bolus and or with patient controlled demand doses Delivery Methods The pump provides the following methods of delivery Continuous rate infusion of drug at a constant programmed rate 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 t...

Page 7: ...l Type set as PCA Lockout PCA Lockout Delivery of PCA dose moves out the delivery of the next IB Example 3 Intermittent Boluses IB and PCA doses with Bolus Interval Type set as Bolus Interval IB PCA dose Time Dosage PCA dose denied IB IB Next Bolus delay Intermittent Bolus IB Interval IB Delivery of PCA dose moves out the delivery of the next IB Bolus Interval Type set as Bolus Interval Intermitte...

Page 8: ...cator Lights Amber Green AC Power Jack Keypad Blue AC Power Light Remote Dose Cord Jack USB Port 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 Serial number ...

Page 9: ...ntermittent 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 Increment mg Max mg Concentration mg mL Increment mg Max mg 0 1 0 01 5 20 1 00 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 25 2250 2 0 10 100 ...

Page 10: ... 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 75 3750 10 0 50 500 80 4 00 4000 11 0 55 550 85 4 25 4250 12 0 60 600 90 4 50 4500 13 0 65 650 95 4 75 4750 14 0 70 700 100 5 00 5000 15 0 75 750 200 10 00 10 000 20 1 00 1000 300 15 00 15 000 25 1 25 1250 400 20 00 20 000 30 1 50 150...

Page 11: ...cluding cassette and accessories 4 1 cm 10 2 cm 12 7 cm 1 6 in 4 in 5 in Weight Including 4 AA alkaline batteries excluding other accessories 595 g 21 oz System operating temperature 15 C to 40 C 59 F to 104 F System storage and transportation temperature 20 C to 60 C 4 F to 140 F Moisture protection Splashproof E per IEC 60529 Relative humidity 20 to 90 relative humidity non condensing Atmospheri...

Page 12: ...attery end of life Remote dose cord key stuck Reservoir volume empty Stop mode reminder Upstream occlusion Medium priority alarms 19 Low priority alarms 8 Informational messages alerts 23 Delivery rate during priming Standard volume cassette tubing approx 250 mL hr High flow volume cassette tubing 500 mL hr Alarm disabled during priming Air In Line Maximum infusion pressure 1 86 bar 27 0 psi High ...

Page 13: ...lusion Raw Test Data min Spec min Raw Test Data mL Spec mL 0 1 CADD medication cassette reservoir 21 7002 with CADD extension set 21 7047 90 160 0 107 0 25 CADD administration set 21 7091 122 190 0 139 0 30 CADD high volume administration set 21 7055 1140 1200 1 250 1 40 Flow Rate mL hr Tubing Set Max Time to Occlusion Max Bolus at Occlusion Raw Test Data sec Spec sec Raw Test Data mL Spec mL 10 C...

Page 14: ...zation of typical use An additional 4 8 change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 40 mL hr An additional 7 2 change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 250 mL hr Using CADD administration sets 6 nominal at 15 C to 40 C with no back pressure An additional 2 5 change may be ...

Page 15: ...crements PCA dose 0 mL to 50 mL or the mg or mcg equivalent Delivery rate 40 mL hr to the maximum delivery rate in 1 mL increments PCA dose lockout 1 minute to 24 hours in the following increments 1 minute for values between 1 and 20 minutes 5 minutes between 20 minutes and 24 hours Intermittent bolus 0 mL to 50 mL or the mg or mcg equivalent Intermittent bolus interval 0 to 4 hours Next bolus 0 t...

Page 16: ...Air detector sensitivity Low Sensitivity Single bubble 400 μL High Sensitivity Single bubble 150 μL Upstream occlusion sensor On Off Note The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs Downstream occlusion sensitivity High Sensitivity When the high pressure alarm threshold is reached the downstream occlusion alarm is triggered immediately Low...

Page 17: ...hs 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 button to receive a PCA PCEA dose For easy access the remote dose cord may be fastened to the patient s clothing or bedsheet with the attached clip Note To detach the remote dose cord from the...

Page 18: ...is AC adapter It can be plugged directly into the AC adapter or it recharges in the CADD Solis pump with an AC adapter attached Note Periodically inspect the rechargeable battery pack for damage or wear to the metal or plastic insulation Discontinue use if any damage is noted See the instructions for use supplied with the rechargeable battery pack for more information Battery Storage The CADD Soli...

Page 19: ...ilable for replacement Continuous Delivery Delivery Rate mL hr Operating Time hr Volume Delivered mL 0 4 142 56 1 139 139 5 0 124 620 10 0 113 1130 30 0 69 2070 Intermittent Bolus Delivery IB Volume mL IB Interval min Maximum Delivery Rate mL hr Operating Time hrs Volume Delivered mL 5 30 40 90 900 10 30 250 104 2080 10 30 500 88 1760 Rechargeable battery pack life with screen backlight intensity ...

Page 20: ... 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 Contact your local distributor or visit the following web site for specific instructions http www smiths medical ...

Page 21: ... tactile feel when the key is pressed The keypad keys are sensed by the pump microprocessor The top left and top right keys are designated soft keys meaning that they operate based on the messages displayed on the screen directly above them The liquid crystal display LCD also located on the front housing shows the pump status and programmed settings The content of the multicolor display is determi...

Page 22: ...life The backlight is shut off by the microprocessor when the LCD is turned off The LCD backlight flashes for 12 ms during each motor operation LED Status Indicators An amber and a green light emitting diode LED on the front panel of the pump provide pump status to the user Under software control the LEDs can either flash at a low duty cycle or be on continuously A flashing indicator typically ind...

Page 23: ...ng Inlet Valve Outlet Valve A simulated pumping mechanism in a CADD Solis pump Upstream Occlusion Sensor Air Detector Sensor Downstream Occlusion Sensor Expulsor Cassette Sensors Inlet Valve Outlet Valve Bottom view 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...

Page 24: ... the timer circuits to accurately time the 18 seconds in this example between mechanism activations Cassette Type Sensor Circuit The cassette Type sensor system consists of 3 pins protruding from the bottom of the pump mechanism that interface with the attached CADD administration set and associated circuitry Each type of administration set designed to work with the CADD Solis pump contains a uniq...

Page 25: ... not proceed with using the pump Follow your facility s procedures for downloading protocol libraries Note Document the error numbers displayed on the system fault screen to help Smiths Medical Customer Service identify the problem Order of System Fault Alarm Events 1 There is a continuous two tone audible alarm the amber LED indicator light is on continuously and the display looks like this Recor...

Page 26: ...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 The following steps may be used to clean and disinfect the pump and accessories unless otherwise specified in the instructions for use for an accessory 1 Clean the pump and its access...

Page 27: ...Inspection Visually inspect the pump for any damage to the LCD occlusion sensor seals valves and expulsor cassette hinge area latch handle USB connector lock 3 cassette sensors keypad indicator lights AC power jack remote dose jack air detector sensor and housings Check the battery door for proper operation It should not be cracked or broken Inspect the battery door seal for proper position Examin...

Page 28: ...medication cassette reservoir to the pump The status bar should temporarily show Reservoir Cassette Latched 2 Lock the cassette by inserting a key into the lock and turning clockwise The status bar should temporarily show Cassette Locked 3 Unlock the cassette by inserting a key into the lock and turning counterclockwise The status bar should temporarily show Cassette Unlocked 4 Unlatch the cassett...

Page 29: ...or that setting i When the review is complete select Next j The screen displays Cassette not attached Attach cassette before starting pump Select Home 2 Attach a CADD medication cassette reservoir or CADD administration set to the pump Latch and lock the cassette 3 The screen displays Prime tubing Prime the pump as follows a Select Yes b Select Prime c The screen displays Reservoir Volume low Are ...

Page 30: ... and count the activations One activation should occur every 12 seconds After approximately 1 minute 50 seconds 1 50 and 10 activations the reservoir empty alarm should occur 23 The display should show Reservoir volume is zero Pump stopped Select Acknowledge Remote Dose Cord Check 24 Attach the remote dose cord 25 Program the pump with the following parameters Continuous Rate PCA Dose PCA Lockout ...

Page 31: ...Go back to the Home screen and then program the pump with the following parameters Continuous Rate PCA Dose PCA Lockout Reservoir Volume 0 0 mL hr 1 0 mL 1 min 10 0 mL 3 Attach latch and lock an empty CADD medication cassette reservoir or CADD administration set to the pump 4 When the screen displays Reset reservoir volume to 10 mL select Yes 5 When the screen displays Prime tubing select No 6 Whe...

Page 32: ... medication cassette reservoir or CADD administration set to the pump 5 Start the pump and allow it to run for a minimum of 4 minutes 6 Start a timer to measure the time the audible alarm is active Open the battery door 7 The pump should respond with a continuous 2 tone alarm The alarm should sound for a minimum of 2 minutes Audible Alarm Check Procedure 1 From the Tasks menu select Adjust Alarm V...

Page 33: ...female Luer of the CADD medication cassette reservoir 4 Program the pump to the following parameters Units Continuous Rate PCA Dose PCA Lockout Reservoir Volume mL 0 0 mL hr 1 0 mL 1 min 10 0 mL 5 Start the pump and activate a PCA dose noting when the high pressure alarm is activated 6 The pump should alarm when the pump delivers between 1 and 2 activations Downstream Occlusion Pressure Range Test...

Page 34: ...0 62 bar CAUTION 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 otherwise the cassette may rupture Safety glasses should be worn while conducting or observing this test Upstream Occlusion Sensor Test Description The tubing between the fluid reservoir and the pump is occluded while the pump is runn...

Page 35: ...0 mL water 2 Transfer the water into a CADD medication cassette reservoir Remove any air from the CADD medication cassette reservoir by aspirating the air with the syringe 3 Fill the syringe with 3 5 mL water 4 Attach the syringe to the end of the CADD extension set that does not contain the anti siphon valve Prime the tubing so it is filled with fluid to the end of the CADD extension set 5 Secure...

Page 36: ... This is the inaccuracy volume 17 Divide the inaccuracy volume by the intended delivery volume and multiply by 100 This is the accuracy error percentage 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 41 6 g Weight of Amount...

Page 37: ...L water 4 Attach the syringe to the end of the CADD extension set that does not contain the anti siphon valve Prime the tubing so it is filled with fluid to the end of the CADD extension set 5 Secure the clamp on the CADD extension set 6 Remove the CADD extension set from the syringe and attach it to the CADD medication cassette reservoir 7 Attach the end of the CADD extension set to the fluid col...

Page 38: ... Example Actual Delivery Volume 19 5 mL Intended Delivery Volume 20 0 mL Inaccuracy Volume 0 5 mL Inaccuracy Volume 0 5 mL Intended Delivery Volume 20 0 mL Accuracy Error 0 025 Accuracy Error 0 025 100 00 Accuracy Error Percentage 2 5 ...

Page 39: ...ck III Functional Testing Power up LCD Stop Start pump LED Air detector Latch Lock Activation timing Battery fallout alarm Cassette sensor Remote dose cord Audible alarm Motor reservoir is zero Doses given attempted IV Occlusion Pressure Range Tests Note Perform either downstream test 1 or test 2 but not both Downstream Test 1 Activations before alarm _________________ Downstream Test 2 High press...

Page 40: ... 0 1233 722100 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 Patent and Trademark Office and certain other countries All other names and marks mentioned are the trade names trademarks or service marks of their respective owners 2013 Smiths Medical All rights reserved 2 x ...

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