Smiths Medical CADD 2120 Technical Manual Download Page 38 | Manualshive

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38

a

nnual

I

nsPectIon

and

t

estIng

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%

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Summary of Contents for CADD 2120

Page 1: ...CADD Solis VIP Ambulatory Infusion Pump Technical Manual Model 2120 s X ...

Page 2: ...ction in the CADD Solis VIP Operator s Manual for more information Your facility may load a unique single protocol or protocol library on the CADD Solis VIP ambulatory infusion pump When a pump is returned to Smiths Medical for service the protocol or protocol library may be cleared as part of the service or repair process If this occurs the pump will be labeled with a sticker indicating the chang...

Page 3: ...ttery Life 17 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 Battery Status 23 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 Fault Alarm...

Page 4: ...e 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 contact your Smiths Medical representative or call Customer Service at 1 800 258 5361 USA or 1 2...

Page 5: ...e 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 use any instrument to remove it from the pump Inspect the AA batteries for damage or wear to the metal or plastic insulati...

Page 6: ...nfusion Epidural administration is limited to short term infusion of anesthetics and either long or short term infusion of analgesics Subarachnoid administration is limited to short term infusion of analgesics PCA Delivery Profile PCA patient controlled analgesia delivery is used for therapies that require a continuous rate of infusion patient controlled demand doses or both such as patient contro...

Page 7: ...ivery Profile Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and or end and has a programmable KVO rate at the end of the infusion Time Delivery Rate Delayed start optional KVO KVO Dose Dose Duration Duration Cycle KVO Time Delivery Rate Plateau rate Initial rate Rate step increase Delayed start optional KVO Rate step increase KVO Infusion volume Step...

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: ...PCA Dose and Clinician Bolus Scroll Ranges Units Starting Value Increment Max Milliliters 0 0 05 50 PCA Dose and Clinician 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 50 2 50 ...

Page 10: ... 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 1500 500 25 ...

Page 11: ...e detected Battery depleted while delivering Battery removed while delivering Battery unusable while delivering Disposable attached improperly Disposable detached while delivering Disposable locked but not latched Disposable type high flow administration set not allowed Disposable type high flow administration set required Disposable type invalid Downstream occlusion Key stuck Pressure sensor faul...

Page 12: ... CADD extension set 21 7045 4 45 0 069 0 25 CADD administration set 21 7091 4 45 0 072 0 30 CADD high volume administration set 21 7055 32 90 1 059 1 40 Power sources AC adapter CADD Solis rechargeable battery pack Four AA alkaline batteries for example Duracell PC1500 MN1500 IEC LR6 Charging system for internal memory backup battery The internal memory backup battery uses lithium manganese dioxid...

Page 13: ...e reservoirs 6 nominal at 15 C to 40 C with no back pressure An additional 2 5 change may be seen at 100 mmHg 1 9 psi Using CADD administration sets 6 nominal at 15 C to 40 C with no back pressure An additional 2 5 change may be seen at 100 mmHg 1 9 psi Using CADD high volume administration sets 6 nominal at 15 C to 40 C with no back pressure An additional 5 change may be seen at 100 mmHg 1 9 psi ...

Page 14: ...rm volume High Medium Low PM preventive maintenance reminder Interval 1 to 24 months in 1 month increments Enable On or off Custom keypad code 001 to 899 in increments of 1 Custom clinician code 001 to 899 in increments of 1 Custom administrator code 001 to 899 in increments of 1 Date format US standard month day year European standard day month year International standard ISO 8601 2004 year month...

Page 15: ...mcg equivalent PCA dose 0 mL to 50 mL or the mg or mcg equivalent Max delivery rate continuous rate PCA dose 40 to 250 mL hr 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 Max doses per hour 1 to 60 Delivery limit amount 0 1 to 1900 mL or the mg or mcg equivalent in increments of 0 01 mL from ...

Page 16: ...Solis VIP ambulatory infusion pump is limited by any warnings precautions or contraindications in the drug labeling Route of Delivery Drug Tested Intravenous subarachnoid space intrathecal Morphine Sulfate Injection Intra arterial Floxuridine for Injection USP Intraperitoneal Dianeal with dextrose Epidural space local infiltration subcutaneous perineural surgical site Ropivacaine HCl Injection Rem...

Page 17: ...the CADD Solis AC adapter It can be plugged directly into the AC adapter or it recharges in the CADD Solis VIP 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 Stora...

Page 18: ...d Continuous delivery Max delivery rate 100 mL hr when using the PCA delivery mode Delivery Rate mL hr Operating Time hrs Vol Delivered mL 0 4 142 56 1 0 139 139 5 0 124 620 10 0 113 1130 30 0 69 2070 50 0 59 2950 125 0 37 4625 200 0 29 5800 350 0 15 5250 500 0 11 5500 Intermittent delivery Volume mL Duration hr Cycle hr KVO mL hr Operating Time hrs Vol Delivered mL 20 2 1 4 0 2 131 684 40 7 0 1 4...

Page 19: ...e hrs Volume mL 0 4 74 29 1 0 67 67 5 0 60 300 10 0 50 500 30 0 40 1200 50 0 35 1750 125 0 30 3750 200 0 20 4000 350 0 13 4550 500 0 10 5000 Intermittent delivery Volume mL Duration hr Cycle hr KVO mL hr Operating Time hrs Vol Delivered mL 20 2 1 4 0 2 81 436 40 7 0 1 4 0 2 68 702 61 0 1 6 0 2 85 929 125 0 1 6 0 2 53 1133 200 0 1 12 0 2 95 2424 Step delivery Volume to Deliver mL Starting Rate mL h...

Page 20: ...butor or visit the following web site for specific instructions http www smiths medical com recycle index html Non European Union residents must dispose of or recycle this product including batteries in accordance with the local laws or regulations that apply WARNING There are potential health hazards associated with improper disposal of batteries electronics and contaminated used reservoirs and e...

Page 21: ...ain domes to provide a 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 multico...

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: ...elivery operation stops Shut down Pump shuts off due to too low operating voltage Pumping Mechanism The pumping mechanism is linear peristaltic with 2 active valves Pumping occurs when the expulsor presses on the reservoir tubing in sequence with the inlet and outlet valves At rest the outlet valve is pressing down fully on the tubing and the expulsor and inlet valve are retracted Motor Camshaft L...

Page 24: ...r 20 mL hr for example the microprocessor solves the following equations Mechanism activations per hour Time seconds between activations Rate mL hr Volume Resolution mL Cassette or Admin Set 0 15 15 1 500 0 050 0 100 The microprocessor uses the timer circuits to accurately time the 18 seconds in this example between mechanism activations Cassette Type Sensor Circuit The cassette Type sensor system...

Page 25: ...lost do 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 thi...

Page 26: ...or slot and remove any debris A blocked air detector sensor may not detect air present in the fluid path which could result in serious patient injury or death CAUTION Do not immerse the pump in cleaning fluid or water Do not allow solution to soak into the pump accumulate on the keypad or enter the battery compartment USB port remote dose cord jack or power jack areas Moisture buildup inside the p...

Page 27: ...ual 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 Ex...

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: ...ue for that setting j When the review is complete select Next k 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 Unlock the keypad if required and select Prime c The scr...

Page 30: ...tions 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 From the Tasks menu select View Delivery Settings Program the pump with the following parameters Continuo...

Page 31: ...2 From the Tasks menu select View Delivery Settings 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...

Page 32: ...on 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 Display and Sound Setti...

Page 33: ... 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 2 CAUTION At the completion of the Downstream Occlusion Pressure Range Test 2 the pressu...

Page 34: ...re 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 running until the occlusion alarm sounds Equipment needed CADD administration set with anti siphon ...

Page 35: ... 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 the clamp as close as possible to the distal end anti siphon valve end of the CADD extension set This should assure a minimum water loss from the tubing when ...

Page 36: ...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 Delivered 19 5 g 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...

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: ...lock 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 pre...

Page 40: ...ries All other names and marks mentioned are trade names trademarks or service marks of their respective owners 2012 Smiths Medical All rights reserved Smiths Medical ASD Inc St Paul MN 55112 USA 1 800 258 5361 USA 1 214 618 0218 www smiths medical com Smiths Medical International Ltd TN25 4BF UK 44 0 1233 722100 Aus Smiths Medical Australasia Pty Ltd 61 Brandl Street Eight Mile Plains QLD 4113 Au...

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