Smiths Medical CADD-Solis Operator'S Manual Download Page 64

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Smiths Medical MD, Inc.

St. Paul, MN 55112 USA

1 800.426.2448 (USA)

+1 651.633.2556

www.smiths-medical.com

Smiths Medical International Ltd.

WD24 4LG, UK

Tel: +44 (0) 1923 246434

Smiths Medical Australasia Pty. Ltd.

61 Brandl Street,

Eight Mile Plains, QLD 4113, Australia.

Tel: +61 (0) 7 3340 1300

2009-01

40-5497-51D

2 6

CADD-Solis, CADD, and the CADD and Smiths Medical design marks are trademarks of the Smiths Medical family of companies.

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 trade names, trademarks, or service marks of their respective owners.

The products described are covered by one or more of the following U.S. Patent Nos.: 5181910, 5695473, 5935106, 5338157,

6024539, 5531697, 5647854, 6123686, 5364242, 5658250, 5935099, 6241704, 6475180, 7347836, 5876370. Other U.S. and

foreign patents pending.

Summary of Contents for CADD-Solis

Page 1: ...s X This online version differs from the printed version Certain information that is not intended for patients has been removed ...

Page 2: ......

Page 3: ...Inc 1265 Grey Fox Road St Paul MN 55112 1 800 426 2448 1 651 633 2556 www smiths medical com European Distribution Smiths Medical International Ltd WD24 4LG UK 44 0 1923 246434 Read this entire Operator s Manual before operating the CADD Solis ambulatory infusion pump Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient WARNINGS This ...

Page 4: ...r other routes of infusion for example by color coding or other means of identification Do not use rechargeable NiCd or nickel metal hydride NiMH batteries Do not use carbon zinc heavy duty batteries They do not provide sufficient power for the pump to operate properly Always have new batteries available for replacement If power is lost non delivery of drug will occur There is no pump alarm to ale...

Page 5: ...pon drug viscosity catheter size and extension set tubing for example microbore tubing and placing the infusion reservoir and or pump above or below the level of the patient The use of power supplies and a remote dose cord other than those listed in the electromagnetic emissions declaration may result in increased emissions or decreased immunity of the pump The pump should not be used adjacent to ...

Page 6: ...of permanent damage to the pump s electronic circuitry The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions or diagnostic levels of radiographic and fluoroscopic radiation If the pump must remain in the vicinity during a diagnostic or therapy session it should be shielded and its ability to function properly should be confirmed following treatme...

Page 7: ...ty Settings 21 Security Level Table 21 Autolock 22 Tasks 22 Give Clinician Bolus 22 Start New Patient 23 Start New Protocol Same Patient 24 Prime Tubing 24 Set Time and Date 25 Adjust Backlight Intensity 26 Adjust Alarm Volume 26 View Reports 26 Adjust Admin Settings 27 Reports 27 Given and PCA Dose Counters 27 PCA Dose Graph 28 Delivery History and Pie Chart 28 Delivery Log 28 Event Log 28 Protoc...

Page 8: ...reens Menus Maps 51 Default Factory Settings 52 Accuracy Test Results 53 Start up curve over the stabilization period Flow rate Intermediate 10 mL hr 53 Trumpet Curve over T 2 Period Intermediate rate 10 mL hr 53 Index 55 Limited Warranty 59 ...

Page 9: ...stration of analgesics to the epidural space is limited to use with indwelling catheters specifically indicated for either short or long term drug delivery Anesthetics Administration of anesthetics to the epidural space is limited to use with indwelling catheters specifically indicated for short term drug delivery WARNING Do not administer drugs to the epidural space or subarachnoid space unless t...

Page 10: ...eable battery pack charge level Rechargeable battery pack charge level with AC adapter AA battery charge level AA battery charge level with AC adapter No battery installed AC power only Incompatible battery Incompatible battery with AC adapter Pump status is running Pump status is paused or in KVO Pump status is stopped Arrows used in the soft key bar indicating there are more items to see by pres...

Page 11: ... keypad prevents entering values outside of defined program limits Designate authorized users with levels of security access Patient Care A versatile multi therapy infusion system designed to support pain management medication delivery needs The compact lightweight design promotes patient mobility which is associated with improved clinical outcomes reduced length of stay and reduced treatment cost...

Page 12: ... menu Alarm alert screens are color coded to low medium and high priority conditions Therapy qualifier drug concentration units and keypad lock status displayed at all times except when viewing reports or during alarm alert conditions Print bar codes and prescription forms Hardware design highlights Cassette latch designed to help easily attach the medication cassette reservoir PCA dose key on pum...

Page 13: ...elps keep the display visible in low light In this manual display is synonymous with display panel or LCD After a period in which no keys are pressed the backlighting turns off and the display goes blank to save battery power except during an alarm or when an external power source is in use You may press any key to turn the display back on NOTE When the display is blank you can determine that the ...

Page 14: ... the power jack When the AC adapter is plugged in the blue power light turns on This light is on regardless of the pump s on or off status See Desktop AC Adapter on page 15 for more information USB Port A mini B USB cord can be attached to the USB port for communications with the CADD Solis Medication Safety Software Remote Dose Cord Jack The remote dose cord jack is used for attaching the remote ...

Page 15: ...linician Bolus used here as a loading dose PCA Doses Continuous Rate Time Dosage Delivery Methods The pump provides the following methods of delivery Continuous Rate see page 30 PCA Dose see page 30 Clinician Bolus see page 22 ...

Page 16: ...e CADD Solis 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 them 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 Replace the batteries if any damage is noted The pump retains all programm...

Page 17: ...After the power up is completed listen for the Morse Code OK sound a series of six audible beeps If you do not hear this sound there may be a problem with the audible alarms If you believe there is a problem remove the pump from service and contact Smiths Medical Customer Service If any issues are found while the pump is performing the self tests alarms will sound e g if the battery is low or a ke...

Page 18: ...nstructions and warnings pertaining to the medication cassette reservoir or CADD administration set please refer to the instructions for use supplied with the product for preparing the product for use Remote Dose Cord The remote dose cord can be attached to the pump and provided to the patient as an alternative to pushing the PCA dose key when requesting a PCA dose The LED on the remote dose cord ...

Page 19: ... i The units of measurement mL mg or mcg and the concentration if units are mg or mcg for the current protocol The name of the screen displayed and help text for the screen if there is any This screen for example is the home screen The work area contents for the screen being displayed in this example the patient specific parameters are on display Options for navigating the pump These options will ...

Page 20: ...libraries are created with the CADD Solis Medication Safety Software and can be imported into the pump by your CADD Solis system administrator Before programming the pump for a patient make sure the pump contains a protocol library If you are not using the CADD Solis pump with a protocol library see Manual Mode Programming on page 32 A protocol from the library may be manually edited in the admini...

Page 21: ...tte from the pump Removing the cassette without closing the clamp could potentially cause unregulated gravity infusion which could result in patient injury or death To remove the cassette 1 Close the tubing clamp 2 If locked insert the pump key and turn the cassette keypad lock counter clockwise into the unlocked position Cassette Unlocked will briefly appear in the status bar 3 Push down on the c...

Page 22: ...tus bar and the amber indicator light will flash while the green indicator light will be off To stop the pump 1 Press stop start 9 NOTE If a PCA dose or clinician bolus is in progress Stop PCA dose or Stop clinician bolus will appear Select Yes to stop the dose 2 When Stop Pump appears select Yes Press here to select Press here to select ...

Page 23: ...curity LevelTable The keypad code should be used by clinicians who need to set up and manage a protocol for a patient The clinician code will allow access to all the functions the keypad code allows as well as the clinician bolus feature The administrator code will allow access to all functions of the pump and its use should be restricted to the CADD Solis system administrator and certain designee...

Page 24: ...ed to meet both safety and usability needs The autolock feature reduces the chance of non authorized pump programming When the keypad is unlocked using the security code and left unlocked pushing the right soft key twice from the home screen will ensure that the pump has been locked the software will eventually lock the keypad This autolock feature takes affect on the home screen approximately 30 ...

Page 25: ...t the clinician bolus where it left off or to start with a new clinician bolus WARNING Exercise care when using the clinician bolus function Since there are no limits on the frequency of delivering a bolus and since the amount of the bolus can be set as high as 20 mL or the mg or mcg equivalent you should not permit the patient to become familiar with the procedure for giving a clinician bolus Imp...

Page 26: ...herwise priming will automatically stop once it has primed 10 mL Continue priming as needed 2 Unlock the keypad using the security code or the pump key 3 Press U or D to highlight the desired therapy and press S 4 Press U or D to highlight the desired qualifier and press S 5 Press U or D to highlight the desired drug and concentration and press S 6 The new protocol will display on the screen and t...

Page 27: ...t s therapy The pump must be stopped and you ll need the keypad code or a higher level code or the cassette keypad lock must be unlocked To access the set time and date feature from the tasks menu 1 Press U or D to choose Set Time and Date and press S To set the current time 1 Press U or D until Current Time is highlighted and press S 2 Unlock the keypad using the security code or the pump key 3 P...

Page 28: ...ess S 2 Unlock the keypad using the security code or the pump key Press here to Save 3 Press U or D to scroll from 1 to 10 The pump will display the intensity of each number as it appears Once you have found the desired backlight intensity select Save Adjust AlarmVolume The adjust alarm volume feature allows you to determine the volume of the alarms in the protocol You may choose between 3 volumes...

Page 29: ...olis Medication Safety Software The administrator settings only allow you to make changes to the protocol currently displayed To access the administrator settings 1 From the tasks menu Press U or D to choose Adjust Admin Settings and press S NOTE You cannot access the administrator settings without the administrator code See the Administrator Settings Guide for more information Reports The reports...

Page 30: ...hart 1 From the reports menu press U or D to choose Delivery History and Pie Chart and press S Delivery Log The delivery log is a subset of the event log and contains information having to do specifically with delivery events Delivery log information includes PCA dose deliveries Clinician boluses Changes to the patient specific parameters including continuous rate PCA dose PCA dose lockout deliver...

Page 31: ... the protocol If the option is available use the pump key to place the pump in the unlocked position see picture OR Enter the keypad code see Security Settings on page 21 NOTE Using the pump key to unlock the keypad also unlocks the cassette latch see Attach a Cassette on page 18 for more information To view the event log 1 From the Reports menu press U or D to choose Event Log and press S While v...

Page 32: ...pump key NOTE When using the pump key to unlock the keypad be sure to keep the cassette latch in the latched position Continuous Rate The continuous rate is the constant hourly rate the drug is delivered at while the pump is running The continuous rate value can be edited while the pump is running or stopped if the keypad is unlocked To edit the continuous rate 1 From the Home screen press U or D ...

Page 33: ...until you reach the desired PCA lockout time and select Save NOTES If the delivery limit is reached while a PCA dose is in progress the PCA dose will not be completed A PCA dose cannot be started while another PCA dose or a clinician bolus is in progress Pressing the remote dose cord button will turn the display back on AND deliver a PCA dose if available A blank display will not require two key p...

Page 34: ...ts of the previous protocol will be erased The hard and soft limits are all set to the factory default which means the delivery ranges are not limited See the following chart for details NOTE If the pump was set to the factory default or if you are using the pump for the first time the previously selected protocol is the factory default settings Refer to the table on page 52 to see what the factor...

Page 35: ... Air detector sensitivity Remains the same as the previously used protocol Time and date settings Remains the same as the previously used protocol PM reminder on off Remains the same as the previously used protocol PM reminder interval Remains the same as the previously used protocol Display and sound settings Remains the same as the previously used protocol Security settings Remains the same as t...

Page 36: ...t limit override on each screen see page 52 for the factory default settings The parameter and value will be displayed in amber WARNING The manual mode does not contain programming limits Be sure to carefully review each parameter to ensure it accurately matches the prescription Failure to set the manual mode to the correct values could result in serious patient injury or death 7 Once you have acc...

Page 37: ...tanding the Alarms and Messages There are multiple alarms that the pump can sound Many of the alarms will give you the option to acknowledge or silence Choosing to acknowledge the alarm will clear it from the screen choosing to silence the alarm will keep it on the screen but silence it for 2 minutes before it sounds again It will continue until the alarm is acknowledged or resolved The alarms may...

Page 38: ... acknowledge to clear the alarm then If the fluid path contains air bubbles close the clamps and disconnect the fluid path from the patient Then follow the instructions for removing air by priming see Prime Tubing on page 24 for more information on priming Restart the pump Battery depleted Pump stopped High The pump was delivering and is now stopped and the battery power is too low to operate the ...

Page 39: ...voir volume in the pump is set to zero Select acknowledge to clear the alarm Edit the reservoir volume to the correct value If appropriate start the pump See Patient Specific Parameters on page 29 for more information about the reservoir volume Cannot start pump with rechargeable battery reached end of use Medium The rechargeable battery pack is at the end of its life It has been discharged and re...

Page 40: ...knowledge to clear the alarm Reattach the cassette and if appropriate restart the pump Cassette locked but not latched Unlock and reattach the cassette High The cassette keypad lock is locked but there is no cassette attached The pump is stopped and will not run Select acknowledge to clear the alarm Unlock the cassette keypad lock and reattach the cassette Cassette not attached properly Reattach c...

Page 41: ...y activities and does not have sufficient resources to support the programmed delivery rate The delivery has fallen behind by 1 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 charging Low The rechargeable battery pack is depleted and is being recharged with the A...

Page 42: ...urn the pump for service New pump settings downloaded Press Acknowledge then review Low A new protocol was just downloaded into the pump from the CADD Solis Medication Safety Software Select acknowledge to clear the alarm Review the protocol to ensure the correct one has been downloaded PCA dose cord button stuck Release or remove cord High The PCA remote dose cord button may be pressed down The p...

Page 43: ... use Replace battery Medium The rechargeable battery pack is near the end of its life It has been discharged and recharged so many times that it will soon be at the end of its use You may continue to use it in this state Rechargeable battery reached end of use Pump will not run High The rechargeable battery pack is at the end of its life It has been discharged and recharged so many times that it i...

Page 44: ...f batteries to use see Installing the Batteries on page 14 Unusable battery Pump will not run Medium The batteries installed are either the wrong kind of AA batteries or you are using a rechargeable battery pack that is not compatible with the pump Select acknowledge to clear the alarm Remove the batteries and install a fully charged rechargeable battery pack or 4 new AA batteries For more informa...

Page 45: ...e surface of the pumping mechanism see the Technical Manual for a diagram of the pumping mechanism Inspect the air detector sensor slot and remove any debris 2 Allow the pump to dry completely before use Exposure to Radiation or Magnetic Resonance Imaging MRI CAUTION The pump SHOULD NOT BE DIRECTLY IRRADIATED by therapeutic levels of ionizing radiation because of the risk of permanent damage to th...

Page 46: ... 1600 85 4 25 1700 90 4 50 1800 95 4 75 1900 100 5 00 2000 0 1 0 01 2 0 2 0 02 4 0 3 0 03 6 0 4 0 04 8 0 5 0 05 10 1 0 05 20 2 0 10 40 3 0 15 60 4 0 20 80 5 0 25 100 6 0 30 120 7 0 35 140 8 0 40 160 9 0 45 180 10 0 50 200 11 0 55 220 12 0 60 240 13 0 65 260 14 0 70 280 15 0 75 300 Milligrams increment max Concentration mg mL Milligrams increment max Concentration mg mL 45 2 25 900 50 2 50 1000 55 ...

Page 47: ...dard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 Edition 2 1 2004 11 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests IEC 61000 4 2 2001 Electromagnetic Compatibility EMC Part 4 2 Testing and measurement techniques Electrostatic Discharge immunity test IEC 61000 4 3 2006 Electromagn...

Page 48: ...perly Disposable type high flow administration set Disposable type invalid Disposable locked but not latched Reservoir volume empty Pressure sensor faulty Downstream occlusion Upstream occlusion Air in line detected Remote dose cord key stuck Key stuck Stop mode reminder Pump was automatically stopped There are an additional 19 medium priority alarms 8 low priority alarms and 20 informational mess...

Page 49: ... F System Storage and Transportation Temperature 20 C to 60 C 4 F to 140 F Relative Humidity 20 to 90 relative humidity non condensing Atmospheric Pressure 70 kPa 10 2 psi to 106 kPa 15 4 psi System Delivery Accuracy 6 nominal At low infusion rates this accuracy may not be achieved for short periods During the total infusion time the accuracy averages out WARNING Ensure that the 6 system delivery ...

Page 50: ...ncentration 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 15 to 100 mg mL in increments of 5 mg mL mcg mL 1 to 15 mcg mL in increments of 1 mcg mL 15 to 100 mcg mL in increments of 5 mcg mL 00 to 500 mcg mL in increments of 100 mcg mL Continuous Rate 0 to 30 mL hr or the mg or mcg equivalent PCA Dose 0 mL to 20 mL...

Page 51: ...ring use with medication cassette reservoirs 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 env...

Page 52: ...be used no closer to any part of the Pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz outside ISM bandsa 3 Vrms Recommended separation distance d 1 2 Conducted RF IEC 61000 4 6 10 Vrms 150 kHz to 80 MHz in ISM bandsb 10Vrms Recommended separation distance d ...

Page 53: ... is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Z 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 env...

Page 54: ... Volume Low trip point 5 0 mL Reservoir Volume Low Alert Type Insistent and One Time Only Repeat Reservoir Volume Empty Alert Type One Time Only Clinician Bolus Amount 0 mL Maximum Fluid Delivery Rate combined bolus and continuous 175 mL hr Pump Stopped Alert Type Informational Upstream Sensor On Downstream Occlusion Sensitivity Low Air Detector Enabled Yes Air Detector Sensitivity Low Date Format...

Page 55: ...uracy of fluid delivery of particular time periods or observation windows is measured trumpet curves The start up curve displays flow rate continuously from the start of the infusion The curve visually represents flow rate uniformity Trumpet curves are derived from the sixth hour of this data Tests performed per IEC60601 2 24 standard Over long observation windows short term fluctuations have mini...

Page 56: ...54 References and Troubleshooting ...

Page 57: ...a Cassette 19 Cassette Keypad Lock 11 12 21 22 29 38 Cassette Latch 11 12 29 CAUTIONS 3 Clinician Bolus 20 21 22 27 28 31 33 48 51 52 Clinician Code 21 Continuous Rate 21 27 28 30 31 33 39 48 51 52 Counters 22 27 30 51 Given 27 PCA Dose 27 Current Date 25 Current Time 25 Curve Start up 53 Trumpet 53 D Date Format 26 Default Factory Settings 51 52 Delivery History and Pie Chart 28 Delivery Limit 22...

Page 58: ...h 11 Power Up 15 Prime Tubing 21 22 24 36 37 51 Programming Screens 29 51 Programming the Pump 17 18 21 28 32 33 48 52 Before Beginning Program 18 Manual Mode 32 Patient Specific Parameters 29 Programming Screens 29 51 Start the Pump 19 Stop the Pump 20 Protocol Library Summary 29 51 Pump development 45 standards 45 Pump Accessories 15 CADD Solis Medication Safety Software 15 cassette 16 desktop A...

Page 59: ...nistration 7 Symbols 8 System Fault Alarm 35 T Tasks 21 22 51 Adjust Admin Settings 22 27 51 Adjust Alarm Volume 21 22 26 51 Adjust Backlight Intensity 21 22 26 Give Clinician Bolus 21 22 51 Prime Tubing 21 22 24 51 Set Time and Date 21 22 25 51 Start New Patient 21 22 23 51 Start New Protocol Same Patient 21 22 24 51 View Reports 22 26 51 Tests Accuracy Tests 53 Time and Date 21 22 25 28 33 51 Tr...

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Page 61: ...t Misuse includes but is not limited to use not in compliance with the Operator s Manual or use with nonapproved accessories The Pump is a sealed unit and the fact that the seal has been broken will be considered conclusive evidence that the Pump has been altered or misused Removal or damage to the Pump s serial number will invalidate this warranty D Limitations and Exclusions Repair or replacemen...

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Page 64: ...demarksoftheSmithsMedicalfamilyofcompanies 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 trade names trademarks or service marks of their respective owners 2009 Smiths Medical family of companies All rights reserved The products described are covered by one or more of the following U S Pat...

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