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Limited Warranty

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Limited Warranty

Smiths Medical ASD, Inc. (the “Manufacturer”) warrants to the Original Purchaser that the CADD®-Solis

Ambulatory Infusion Pump (“Pump”), not including accessories, shall be free from defects in materials and

workmanship under normal use, if used in accordance with this Operator’s Manual, for a period of two years from

the actual date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES.
This warranty does not cover normal wear and tear and maintenance items, and specifically excludes batteries,

administration sets, extension sets or any other accessory items or equipment used with the Pump.
Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or

replace at its option without charge (except for a minimal charge for postage and handling) any Pump (not including

accessories) which is defective if a claim is made during such two-year period.
The following conditions, procedures, and limitations apply to the Manufacturer’s obligation under this warranty:

A. Parties Covered by this Warranty:

This warranty extends only to the Original Purchaser of the Pump. This

warranty does not extend to subsequent purchasers. The Original Purchaser may be a patient, medical personnel,

a hospital, or institution which purchases the Pump for treatment of patients. The Original Purchaser should

retain the invoice or sales receipt as proof as to the actual date of purchase.

B. Warranty Performance Procedure:

Notice of the claimed defect must be made in writing or by telephone to

the Manufacturer as follows: Customer Service Department,

Smiths Medical ASD, Inc.,

1265 Grey Fox Road,

St. Paul, MN 55112, (800) 258-5361 (USA, Canada) or

Smiths Medical International Ltd.

WD24 4LG, UK, +44

(0) 1923 246434. Notice to the Manufacturer must include date of purchase, model and serial number, and a

description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any

repairs which may be necessary. Authorization must be obtained prior to returning the Pump. If authorized, the

Pump must be properly and carefully packaged and returned to the Manufacturer, postage prepaid. Any loss or

damage during shipment is at the risk of the sender.

C. Conditions of Warranty:

The warranty is void if the Pump has been 1) repaired by someone other than the

Manufacturer or its authorized agent; 2) altered so that its stability or reliability is affected; 3) misused; or,

4) damaged by negligence or accident. 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 replacement of the Pump or any component part thereof is the

EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply:
1. No agent, representative, or employee of the Manufacturer has authority to bind the Manufacturer to any

representation or warranty, expressed or implied.

2. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE PUMP FOR ANY

PARTICULAR PURPOSE.

3. The Pump can only be used under the supervision of medical personnel whose skill and judgment determine

the suitability of the Pump for any particular medical treatment.

4. All recommendations, information, and descriptive literature supplied by the Manufacturer or its agents are

believed to be accurate and reliable, but do not constitute warranties.

E. Computer Program License:

1. The Pump is intended to be used in conjunction with a particular Licensed Computer Program supplied by

Manufacturer and use of any other program or unauthorized modification of a Licensed Computer Program

shall void Manufac turer’s warranty as set forth above.

2. The Original Purchaser and any users authorized by the Original Purchaser are hereby granted a nonexclusive,

nontransferable license to use the Licensed Computer Program only in conjunction with the single Pump

supplied by Manufacturer. The Licensed Computer Program is supplied only in machine-readable object code

form and is based upon Manufacturer’s proprietary confidential information. No rights are granted under this

license or otherwise to decompile, produce humanly readable copies of, reverse engineer, modify or create any

derivative works based upon the Licensed Computer Program.

3. All other terms and conditions of this Limited Warranty shall apply to the Licensed Computer Program.

The Manufacturer disclaims responsibility for the suitability of the Pump for any particular medical treatment or

for any medical complications resulting from the use of the Pump. 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 Pump.
This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal

rights which may vary from state to state.

Summary of Contents for 2120

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

Page 2: ...urity codes to those who are authorized Access to the pump key should also be restricted The issue date of this Operator s 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 version of this manual is available Technical Assistance If you have comments or questions concerning the operation of the ...

Page 3: ...pect it for damage Do not use a pump that is damaged or not functioning properly Contact Smiths Medical Customer Service to return a pump for service Use of a syringe with the CADD administration set may result in UNDERDELIVERY of medication Syringe function can be adversely affected by variations in plunger dimension and lubricity which can result in greater force required to move the syringe plu...

Page 4: ... 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 nondelivery of drug occurs A rechargeable battery pack that has reached the end of its useful life must be replaced with either another CADD Solis rechargeable battery pack or with 4 AA batteri...

Page 5: ...mp above or below the level of the patient System delivery inaccuracy may result in under or overdelivery of medication 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 or stacked with other equipment If adjacent or stacked...

Page 6: ...amage the product and cause leakage If delivery of an infusion is affected by a time or date change an alarm message appears and must be confirmed 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 pump may damage the p...

Page 7: ...d Security Settings 22 Keypad Security 23 Keypad Code 23 Clinician Code 24 Administrator Code 24 Manual Programming 25 Pump Programming Protocols and Protocol Libraries 26 New Protocol Selection 26 Single Protocol Download 26 Protocol Selection from a Library 27 Start New Patient 27 Start New Protocol Same Patient 27 Manually Programmed Protocols 28 Delayed Start Next Dose Start Time 31 Delivery H...

Page 8: ... Sensor On Off 103 Downstream Sensor Sensitivity 104 Alarm Settings 105 Infusion Alerts On Off 105 Pump Stopped Alarm Type 105 Reservoir Low Trip Point 106 Reservoir Low Alarm Type 106 Reservoir Empty Alarm Type 107 PM Reminder On Off 107 PM Reminder 108 PM Interval 108 Reset to Factory Settings 109 References and Troubleshooting Alarms and Messages 110 Types of Alarms 110 System Fault Alarm 110 H...

Page 9: ...pump is not to be used in any intra articular space infusion Epidural Subarachnoid Administration The selected drug must be used in accordance with the indications included in the package insert accompanying the drug Administration of any drug by this pump is limited by any warnings precautions or contraindications in the drug labeling Analgesics Administration of analgesics to the epidural space ...

Page 10: ...tralian representative 9 Stop Start button P Temperature limitation PCA Dose button _ Humidity limitation AA battery location positive terminal faces up i Atmospheric pressure limitation AA battery location negative terminal faces up J Type CF equipment AA battery location positive terminal faces up K Class II equipment AA battery location negative terminal faces up E Splashproof water splashed ag...

Page 11: ...Adapter connected Appears next to a parameter that has been reviewed and accepted Pump status is Started or Running On edit screens Indicates current parameter value Press U or D to scroll up or down to edit the value Pump status is Paused On edit screens with a menu of options Indicates which setting is being selected Pump status is Stopped The requested action can not be performed There are more...

Page 12: ... Display Indicator 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 13: ...ode NOTE When the display is blank you can determine that the pump is powered by observing either the green or amber or both indicator lights periodically flashing If you press stop start 9 the display reappears with a message asking if you wish to start or stop the pump If you press PCA dose while the pump screen is blank the pump delivers a PCA dose if that option is available Keypad The keys on...

Page 14: ...ell as the keypad This is configured by the CADD Solis system administrator See Security Settings on page 18 Air Detector The air detector may be turned on or off depending on facility or therapy requirements see Air Detector On Off on page 102 If air is detected in the part of the tubing that passes the air detector sensor an alarm sounds and delivery stops If an air detector is not required it m...

Page 15: ...d to the pump and provided to the patient as an alternative to pushing the PCA dose key to request a PCA dose Polemount Bracket The polemount bracket is used along with the polemount bracket adapter to attach the pump to an IV pole Polemount Bracket Adapter The polemount bracket adapter attaches to the back of the pump so that it can be hung from an IV pole or in a lockbox Polemount Swivel The pol...

Page 16: ... Delivery status of the pump stopped or running The type of battery in use and the approximate amount of life remaining Also indicates if an AC adapter is in use Keypad lock status locked or unlocked iUnits of measurement and concentration if applicable for the drug or solution used in the current protocol Screen name and help text if there is any The work area contents for the displayed screen Th...

Page 17: ...o yellow by using the CADD Solis Medication Safety Software Depending on the needs of your pain management program your facility may choose to relate a purple or yellow screen to a specific protocol including Route of administration for example all epidural protocols or Patient type for example all pediatric protocols or Any other hierarchy which fits the needs of your institution Refer to your fa...

Page 18: ...ed All programming functions are accessible while the pump is unlocked and improper programming could result in serious patient injury or death Security Level Tables The keypad code is for clinicians who need to modify and review patient specific parameters and manage air and occlusion parameter settings The clinician code allows access to all the functions the keypad code allows In addition it al...

Page 19: ... Taper Down Now Taper only Taper Down Period of Taper Down Now Taper only Set Delayed Start Next Dose Start Time Intermittent only Prime Tubing View Delivery Settings Edit Delivery Settings Therapy type determines which submenus appear Display and Sound Settings menu Backlight Intensity Alarm Volume Sound Theme Key Beep On Off Numeric Format Change Time and Date menu Current Time Current Date Time...

Page 20: ... only Step Up Step only Give Clinician Bolus PCA only Patient Permissions Air and Occlusion Settings Alarm Settings Security Settings menu Keypad Security Keypad Code Clinician Code Admin Code Manual Programming Security Start New Patient Select a manual mode protocol Start New Protocol Same Patient Select a manual mode protocol Delivery Hard and Soft Limits menu Therapy type determines which subm...

Page 21: ...sclose pump security codes or any other information that would allow the patient or unauthorized clinician complete access to programming and operating functions Improper programming could result in serious patient injury or death Do not leave the pump unattended while unlocked All programming functions are accessible while the pump is unlocked and improper programming could result in serious pati...

Page 22: ...re or in the security settings under Advanced Tasks See your CADD Solis system administrator for more information or to learn the security code you should use if the codes have been customized The security settings option in the Advanced Tasks menu allows you to customize the pump security codes The keypad code clinician code and administrator code can all be customized to a unique three digit num...

Page 23: ...tor code To set the keypad security 1 From the Security Settings menu press U or D to highlight Keypad Security and press S 2 Unlock the keypad 3 Press U or D to highlight Code Only or Code Or Key and select Save Keypad Code This screen allows you to create a keypad code that is unique to your facility Note The keypad code changes only for the current protocol The change remains in effect until an...

Page 24: ... and press S 2 Unlock the keypad 3 Choose any 3 digit combination of numbers from 001 to 899 Press U or D to enter the new code Press S to advance to the next digit Once the code has been entered select Accept Value 4 Verify the new clinician code by reentering it on the next screen Once the code has been entered press Accept Value Administrator Code This screen allows you to create an administrat...

Page 25: ...y reentering it on the next screen Once the code has been entered press Accept Value Manual Programming The manual programming security option allows you to choose either the clinician or administrator security code to allow access to the manual program protocol To select the code for manual programming 1 From the Security Settings menu press U or D to highlight Manual Programming Security and pre...

Page 26: ...r identify the type of infusion to be delivered Examples of qualifiers include pediatric TPN and epidural Drugs are designated by a name concentration units drug ID combination New Protocol Selection Single Protocol Download 1 Make sure the pump is stopped and on the home screen 2 Connect the pump to the PC using the USB cable Use the CADD Solis Medication Safety Software to load a single protocol...

Page 27: ... starting a new patient However the event log does not insert a new patient marker All other reports are cleared except the delivery log NOTE When starting a new protocol attach a new reservoir with the proper medication To start a new patient and run an existing protocol from a library 1 Make sure the pump is stopped 2 In the Advanced Tasks menu see page 99 press U or D to highlight Start New Pat...

Page 28: ...d be created Manually programming a protocol or making changes to an individual protocol for a single use may occur when the doctor s orders do not match any of the protocols in the library or when a protocol library is not available Unlike protocols that are created and downloaded into the pump by the CADD Solis Medication Safety Software manual programming allows you to choose units and concentr...

Page 29: ...tion 2 hr Dose volume 0 1 mL hr KVO rate 0 mL hr Step Mode Specific Attributes Value Defaults to Infusion alerts Off Initial rate 0 4 mL hr KVO rate 0 mL hr Plateau rate 0 4 mL hr Step duration 30 min Step rate increment 0 4 mL hr Total infusion volume 1 mL Taper Mode Specific Attributes Value Defaults to Infusion duration 24 hr Infusion volume 24 mL KVO rate 1 mL hr Plateau rate upper limit 500 m...

Page 30: ... to back out of the screen allowing you to start over 7 The Review pump settings screen appears Select Review 8 Press U or D to scroll through all the settings If the highlighted setting is correct select Accept Value A green check mark appears next to the setting If the setting is incorrect press S to edit Press U or D to modify the setting and then select Save or Confirm see note NOTE If you edi...

Page 31: ...fusion should begin The pump must be running on the selected date and time in order for delivery to begin If Set Delayed Start is programmed the keep vein open KVO rate is active until the infusion begins NOTE In step and taper therapies you may not set a delayed start after an infusion has been started To Set Delayed Start 1 From the Tasks menu press U or D until Set Delayed Start is highlighted ...

Page 32: ...n Doses appears on the home screen The Next Dose Start Time may also be set to delay delivery of the first dose of the infusion by up to 96 hours The pump must be running on the selected date and time in order for delivery to begin To set the next dose start time 1 Stop the pump if it is running If a dose was delivering when the pump was stopped the Interrupted screen appears NOTE If a dose is in ...

Page 33: ...the hard maximum value Soft Maximum The soft maximum value should be the highest common value for the setting you are programming The setting may be programmed above this value although extra confirmation is required Current Value Displays the current value for the setting in the therapy Changing this setting changes the programmed value in the current therapy Soft Minimum The soft minimum value s...

Page 34: ... most commonly used for the protocol Any programmed value outside the soft limits but within the hard limits is displayed in amber The hard limits are the highest and lowest values that can be programmed for each protocol Changes to any of these settings have a direct impact on the amount of drug delivered to the patient and any changes made in the Delivery Settings menu affect only the therapy th...

Page 35: ... Save NOTE If the new value is above the maximum soft limit or below the minimum soft limit it appears in amber on the screen To select a value above the maximum soft limit or below the minimum soft limit select Confirm and then select Yes Change any additional settings by scrolling through the remaining delivery settings until all values are correct NOTE Changes to any of the delivery settings mu...

Page 36: ...nt To review pump settings 1 When the Review pump settings screen appears select Review 2 Press U or D to scroll through and review all the settings If the highlighted setting is correct press Accept Value A green check mark appears next to the setting and the next setting is highlighted If the highlighted setting is incorrect press S to edit the setting Press U or D to modify the setting and then...

Page 37: ...t a graphic in a shape unique to the therapy and with the colors green red and gray The colors indicate that the pump is running green or stopped red If a new patient or new infusion is programmed but the pump has not been started or if a delayed start time was programmed and the start time passed while the pump was stopped and not yet started the graphic is entirely gray The location of the color...

Page 38: ...A Lockout This is the minimum time that must elapse between the time one PCA dose starts and the time that the next PCA dose is available Delivery Limit This is used to restrict the amount of drug delivered to the patient within a specified time frame The programmable range is 1 hour to 12 hours The limit includes the continuous rate and PCA doses but does not include clinician boluses The frequen...

Page 39: ...ent or Same Patient New Protocol task is selected Start Time This is the time that the next infusion will begin It is displayed only if a delayed start is programmed Programming Example WARNING Ensure that the 6 system delivery accuracy specification is taken into account when programming the pump and or filling the reservoir Failure to do so may result in medication in the reservoir becoming depl...

Page 40: ...onfirm and Review the Settings Review the information on the screen and select Yes if they are correct or No to edit the settings The pump displays the Review pump settings screen Select Review to continue 5 Enter the Continuous Rate Press U or D to highlight Continuous Rate If the value shown is set at the desired rate select Accept Value and go to step 6 If the value shown does not show the desi...

Page 41: ...step 7 If the value shown does not show the desired dose press S Press U or D until the value reads 2 mg and select Save The pump then returns to the Review screen 7 Enter the PCA Lockout Press U or D to highlight PCA Lockout If the time shown is set at the desired value select Accept Value and go to step 8 If the value shown does not show the desired time press S Press U or D until the value read...

Page 42: ...alue reads 2 and select Save The pump then returns to the Review screen 9 Review the KVO Rate In this example the KVO Rate is a calculated value and cannot be edited 10 Enter the Reservoir Volume Press U or D to highlight Reservoir Vol If the value shown is correct select Accept Value and go to step 11 If the value is not correct press S Press U or D until the value reads 100 mL and select Save Th...

Page 43: ...g for example as a loading dose A clinician bolus cannot be started while a PCA dose is in progress The amount delivered decreases the reservoir volume and increases the given amount but does not add to the dose counters or to the delivery limit A clinician bolus may be stopped in progress NOTE If a clinician bolus is manually stopped by a clinician or automatically stopped by an alarm power failu...

Page 44: ...iver the bolus WARNING Never leave the pump unattended while on the clinician bolus edit screen You must deliver the programmed value or cancel and leave the screen Failure to do so could result in serious patient injury or death 6 The screen shows the decreasing amount as the bolus is delivered You may stop the bolus at any time by selecting Stop Bolus 7 When the bolus has been delivered the scre...

Page 45: ...Dose Graph reports 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 indicates PCA dose status Off A PCA dose is not available Flashing A PCA dose is available On A PCA dose has been requested and delivery has started WARNING The remote dose cord is for patient use on...

Page 46: ...unt of the bolus remaining to be delivered You may stop the clinician bolus from this screen by selecting Stop Bolus To stop a PCA dose 1 From the PCA dose started screen you may stop the PCA dose while it is delivering by selecting Stop Dose OR 2 If the pump is on the home screen press the stop start 9 button You will be asked if you want to stop the pump as well as the PCA dose Select No to stop...

Page 47: ...r on the graphic also indicates the status of the infusion The examples below are specific to the continuous delivery mode The pump is running with a programmed delayed start The pump is stopped It will deliver at a continuous rate once it is started Continuous delivery mode graphics do not depict the relative rate of delivery Programming Screens Continuous Rate This is the desired continuous rate...

Page 48: ... system delivery accuracy specification is taken into account when programming the pump and or filling the reservoir Failure to do so may result in medication in the reservoir becoming depleted sooner than expected If the pump is used to deliver critical or life sustaining medication the interruption in the delivery of medication could result in patient injury or death Example Medication is provid...

Page 49: ...e correct or No to edit the settings The pump displays the Review pump settings screen Select Review to continue 5 Enter the Continuous Rate Press U or D to highlight Continuous Rate If the value shown is set at the desired rate select Accept Value and go to step 6 If the value shown does not show the desired rate press S Press U or D until the value reads 125 mL hr and select Save The pump return...

Page 50: ...ol If the value shown is correct select Accept Value and go to step 8 If the value is not correct press S Press U or D until the value reads 1000 mL and select Save The pump then returns to the Review screen 8 Accept Values If any values have not already been accepted press U or D to highlight each setting and select Accept Value if the setting is correct A green check mark appears next to each ac...

Page 51: ...ith the colors green red and gray The colors indicate that the pump is running green or stopped red If a new patient or new infusion is programmed but the pump has not been started or if a next dose start time was programmed and the next dose start time passed while the pump was stopped and not yet started the graphic is entirely gray The location of the color on the graphic also indicates the sta...

Page 52: ...se duration Therefore programming the dose duration may result in an automatic lengthening of the dose cycle in order to maintain the 5 minute difference Entering a dose duration automatically resets the dose cycle and sets the next dose start time to begin immediately Dose Cycle This is the time from the start of one dose to the start of the next dose The programmable values for the dose cycle ar...

Page 53: ...le WARNING Ensure that the 6 system delivery accuracy specification is taken into account when programming the pump and or filling the reservoir Failure to do so may result in medication in the reservoir becoming depleted sooner than expected If the pump is used to deliver critical or life sustaining medication the interruption in the delivery of medication could result in patient injury or death ...

Page 54: ...ey are correct or No to edit the settings The pump displays the Review pump settings screen Select Review to continue 5 Enter the Dose Volume Press U or D to highlight Dose Volume If the value shown is set at the desired volume select Accept Value and go to step 6 If the value shown does not show the desired volume press S Press U or D until the value reads 23 5 mL and select Save The pump returns...

Page 55: ...l the value reads 1 Hrs 0 Min and select Save The pump then returns to the Review screen 7 Enter the Dose Cycle Press U or D to highlight Dose Cycle If the value shown is set at the desired cycle select Accept Value and go to step 8 If the value shown does not show the desired cycle press S Press U or D until the value reads 6 Hrs 0 Min and select Save The pump then returns to the Review screen 8 ...

Page 56: ...ress U or D until the value reads 8 00 PM and select Confirm Confirm the next dose start time by selecting Yes The pump then returns to the Review screen 10 Enter the KVO Rate Press U or D to highlight KVO Rate If the value shown is correct select Accept Value and go to step 10 If the value is not correct press S Press U or D until the value reads 0 2 mL hr and select Save The pump then returns to...

Page 57: ... and select Save The pump then returns to the Review screen 12 Accept Values If any values have not already been accepted press U or D to highlight each setting and select Accept Value if the setting is correct A green check mark appears next to each accepted value After your review is complete select Next 13 Prepare the Pump for the Patient Follow the instructions for attaching a cassette priming...

Page 58: ...t Time For additional information see Next Dose Start Time on page 32 Resuming the Dose To resume delivery of a dose stopped in progress simply restart the pump by pressing stop start 9 Resetting the Cycle To reset the cycle stop the pump between doses and reprogram the Next Dose Start Time When a dose is stopped in progress the Interrupted screen appears To cancel the current dose and reset the c...

Page 59: ...usion is programmed but the pump has not been started or if a delayed start time was programmed and the start time passed while the pump was stopped and not yet started the graphic is entirely gray The location of the color on the graphic also indicates the status of the infusion The examples below are specific to the step delivery mode The pump is running with a programmed delayed start The pump ...

Page 60: ...a new rate increment resets the infusion so that delivery starts at the beginning of the infusion duration Plateau Rate This is the maximum rate at which you want the medication to be delivered The pump begins at the initial rate and increases by the rate increment until the plateau rate is reached The pump runs at the plateau rate until the infusion volume is fully delivered Entering a new platea...

Page 61: ... is primed or delivers fluid Entering a new reservoir volume resets the infusion so that delivery starts at the beginning of the infusion duration The CADD Solis system administrator may choose a standard reservoir volume which allows the reservoir volume to be quickly reset to that value The clinician can edit the reservoir volume to another amount The reservoir volume should not be edited to les...

Page 62: ...to the patient The initial dose must be given at 30 mL hr stepping up by 50 mL hr in 30 minute increments until a plateau rate of 350 mL hr is reached 1 Select the Therapy Stop the pump if it is running Select Tasks then View Advanced Tasks and then Start New Patient Unlock the keypad Press U or D to highlight the Step therapy and press S See Start New Patient on page 27 if you need more informati...

Page 63: ...does not show the desired volume press S Press U or D until the value reads 700 mL and select Save If the infusion volume is greater than the displayed reservoir volume you will be asked to confirm the change in the reservoir volume by selecting OK The pump returns to the Review screen 6 Enter the Initial Rate Press U or D to highlight Initial Rate If the value shown is set at the desired rate sel...

Page 64: ...t Accept Value and go to step 8 If the value shown does not show the desired increment press S Press U or D until the value reads 50 mL hr and select Save The pump then returns to the Review screen 8 Enter the Plateau Rate Press U or D to highlight Plateau Rate If the rate shown is correct select Accept Value and go to step 9 If the value is not correct press S Press U or D until the value reads 3...

Page 65: ...value reads 30 Min and select Save The pump then returns to the Review screen 10 Review the Infusion Duration Infusion Duration is a calculated value and cannot be edited 11 Enter the KVO Rate Press U or D to highlight KVO Rate If the value shown is correct select Accept Value and go to step 12 If the value is not correct press S Press U or D until the value reads 0 mL hr and select Save The pump ...

Page 66: ...ect Save The pump then returns to the Review screen 13 Accept Values If any values have not already been accepted press U or D to highlight each setting and select Accept Value if the setting is correct A green check mark appears next to each accepted value After your review is complete select Next 14 Prepare the Pump for the Patient Follow the instructions for attaching a cassette priming and att...

Page 67: ...message Infusion was interrupted before completion Finish interrupted infusion or start from beginning with new bag Select New Bag to reset the reservoir volume and reset the infusion Or select Finish to resume the infusion from the point it was at when it was last running Step Up This option allows you to increase the rate of infusion at a time other than what is programmed You cannot step up to ...

Page 68: ...automatic step increases after each step duration are cancelled Delivery continues at the step down hold rate The step up task can be used to restart the automatic step increases To step down from the current rate 1 In the Advanced Tasks menu press U or D to highlight Step Down and press S 2 The pump displays a screen that tells you the current rate and asks you if you want to step down to the pre...

Page 69: ...sion is programmed but the pump has not been started or if a delayed start time was programmed and the start time passed while the pump was stopped and not yet started the graphic is entirely gray The location of the color on the graphic also indicates the status of the infusion The graphic used for taper delivery also identifies if taper up and or taper down are programmed as part of the delivery...

Page 70: ...n is limited by a combination of the plateau rate infusion duration infusion volume and taper up You cannot select a taper down duration that would cause the plateau rate to exceed the maximum allowable rate In addition the infusion duration must be at least 10 minutes more than the combined total of the taper up and taper down periods Therefore changing taper down may result in the pump automatic...

Page 71: ... choose a standard reservoir volume which allows the reservoir volume to be quickly reset to that value The clinician can edit the reservoir volume to another amount that should not be less than the programmed infusion volume This change is for the current protocol only and remains in effect until the Start New Patient or Same Patient New Protocol task is selected If KVO delivery is intended at th...

Page 72: ...hours The TPN bag contains 1050 mL of solution Delivery must taper up over 90 minutes at the beginning of the delivery and taper down over 90 minutes at the end of delivery 1 Select the Therapy Stop the pump if it is running Select Tasks then View Advanced Tasks and then Start New Patient Unlock the keypad Press U or D to highlight the Taper therapy and press S See Start New Patient on page 27 if ...

Page 73: ... 6 If the value shown does not show the desired volume press S Press U or D until the value reads 1000 mL and select Save If the infusion volume is greater than the displayed reservoir volume you will be asked to confirm the change in the reservoir volume by selecting OK The pump returns to the Review screen 6 Enter Taper Up Press U or D to highlight Taper Up If the value shown is correct select A...

Page 74: ...nd go to step 8 If the value shown is not correct press S Press U or D until the value reads 1 Hrs 30 Min and select Save The pump then returns to the Review screen 8 Enter the Infusion Duration Press U or D to highlight Infusion Duration If the value shown is correct select Accept Value and go to step 9 If the value shown is not correct press S Press U or D until the duration reads 12 Hrs 0 Min a...

Page 75: ...e and go to step 11 If the value is not correct press S Press U or D until the value reads 0 mL hr and select Save The pump then returns to the Review screen 11 Enter the Reservoir Volume Press U or D to highlight Reservoir Vol If the value shown is correct select Accept Value and go to step 12 If the value is not correct press S Press U or D until the value reads 1050 mL and select Save The pump ...

Page 76: ...ttaching the pump to the patient in Operating the Pump on page 78 Starting Daily Infusion When a new cassette is attached to the pump at the beginning of infusion the reservoir volume should be reset This also resets the infusion Follow the instructions in Operating the Pump beginning on page 78 for attaching a cassette and resetting the reservoir Then when the pump is started delivery will start ...

Page 77: ...ing conditions are necessary for Taper Down Now The pump must be running The pump must be delivering at the plateau rate or already be in taper down To access the Taper Down Now option 1 From the Tasks menu see page 88 press U or D until Taper Down Now is highlighted and then press S NOTE If a taper down was not programmed you can edit the setting by pressing S Enter the security code and then pre...

Page 78: ...ient Always have new batteries available for replacement If power is lost nondelivery of drug occurs and depending on the type of drug being administered could result in death or serious injury to the patient A rechargeable battery pack that has reached the end of its useful life must be replaced with either another CADD Solis rechargeable battery pack or with 4 AA batteries Using rechargeable bat...

Page 79: ... door and using your fingers the pump key or a coin turn the knob on the battery door clockwise to lock NOTE If you put the batteries in backwards the pump will not power up Check the batteries making sure to match the and markings CAUTION Do not store the pump for prolonged periods with the batteries installed Battery leakage could damage the pump NOTES Battery life is dependent on the amount of ...

Page 80: ... If any issues are found while the pump is performing the self tests alarms will sound for example if the battery is low or a key on the keypad is stuck in the pressed position CAUTION If the power up results in an error message indicating that the protocol library was lost do not proceed with using the pump Follow your facility s procedures for downloading protocol libraries Power Down Press the ...

Page 81: ...on set is required for rates above 250 mL hr Appropriate supplies needed to replace cassettes should be available if a cassette is damaged For detailed instructions on preparing the product for use refer to the instructions for use supplied with the product Remove a Cassette 1 Make sure the pump is stopped before removing the cassette 2 Close the tubing clamp WARNING Per general rules of safe prac...

Page 82: ...AUTION If you are using a CADD medication cassette reservoir in which the medication is frozen thaw at room temperature only Do not heat in a microwave oven as this may damage the product and cause leakage Before attaching a new cassette make sure the pump is powered on Once the cassette is attached the pump automatically displays screens that allow you to verify the cassette type prime the fluid ...

Page 83: ...ime Tubing screen always appears When priming security is set to On under patient permissions a screen similar to the one on the right appears and a security code is required to proceed If you do not have permission to prime the tubing or if the tubing is pre primed select No For additional information see Patient Permissions on page 100 If you have permission to prime the tubing select Yes Unlock...

Page 84: ... Do not prime the fluid path with the tubing connected to a patient as this could result in overdelivery of medication or air embolism which could result in serious patient injury or death 5 Stop priming at any time by selecting Stop Priming Priming automatically stops after 10 mL or 20 mL if a high volume set is attached are primed Continue priming as needed WARNING To prevent air embolism ensure...

Page 85: ...ot completed the infusion was not fully delivered a screen appears with the message Infusion was interrupted before completion Finish interrupted infusion or start from beginning with new bag Select New Bag to reset the reservoir volume and reset the infusion Or select Finish to resume the infusion from the point it was at when it was last running 2 When Start Pump appears select Yes NOTE To set a...

Page 86: ...es to stop the dose In a PCA protocol if a clinician bolus is in progress Stop clinician bolus appears Select Yes to stop the bolus A confirmation screen appears stating Clinician bolus stopped Select OK to continue In a taper protocol Taper down instead appears Select No to stop the infusion see Taper Down Now on page 77 if you want to taper down rather than stop the pump 2 When Stop Pump appears...

Page 87: ...trator may set a standard reservoir volume for each therapy that allows you to quickly reset the reservoir volume to that value To reset the reservoir volume to a quantity other than the default setting refer to Editing Delivery Settings on page 35 NOTE If you are running a step or taper therapy resetting the reservoir volume also resets the infusion When you restart the pump delivery starts at th...

Page 88: ...efer to Security Settings on page 18 The following functions are on the Tasks menu Task Menu Function Description on Page Reset Reservoir Volume 87 Taper Down Now Taper therapy 77 Set Delayed Start all therapies except Intermittent 31 Set Next Dose Start Time Intermittent therapy 32 Prime Tubing 83 View Delivery Settings 34 Display and Sound Settings 89 Change Time and Date 92 View Reports 95 View...

Page 89: ... with 1 being low and 10 being high NOTE Increasing the backlight intensity shortens the battery life For example an increase of the backlight intensity from 5 to 10 reduces the battery life by 25 To adjust the backlight intensity 1 In the Display and Sounds Settings menu press U or D to highlight Backlight Intensity and press S 2 Press U or D to scroll from 1 to 10 The pump displays the intensity...

Page 90: ...edium Priority Alarm Low Priority Alarm Informational Alarm To choose a sound theme 1 In the Display and Sounds Settings menu press U or D to highlight Sound Theme and press S 2 Press U or D to highlight Standard Intense or Distinctive and press S to preview the theme or select Save to save the theme without a preview 3 To preview the theme press U or D to scroll through the alarms and beeps Press...

Page 91: ...ecurity code To turn the key beeps on or off 1 In the Display and Sounds Settings menu press U or D to highlight Key Beep On Off and press S 2 Press U or D to highlight Off or On and select Save Numeric Format The numeric format setting allows you to select the character or space used to indicate the decimal point and thousands units separators The formats available are 1 234 56 1 234 56 1 234 56 ...

Page 92: ...matically recharges when the pump is powered on If the pump is off for a long period of time it may not show the correct time and date when it is powered on Check the time and date and edit these settings if necessary CAUTION If delivery of an infusion is affected by a time or date change an alarm message appears and must be confirmed In the Tasks menu press U or D to highlight Change Time and Dat...

Page 93: ...ress U or D to scroll to the correct day and press S to navigate to the year 4 Press U or D to scroll to the correct year and select Save Time Format The time format setting allows you to select either a 12 hour or 24 hour clock format and to set the character used for indicating the hours minutes and seconds separators The formats available are as follows 12 00 00 am pm 12 00 00 am pm 24 00 00 24...

Page 94: ... savings time If you live in a geographical area that follows daylight savings time you must manually update the time and date You may choose to change the time while the pump is currently being used by a patient or wait until the patient is finished with the infusion However because delivery of some therapies is affected by a time and or date change it is recommended that you wait until the infus...

Page 95: ...unning or stopped In the Tasks menu press U or D to highlight View Reports and press S Total Given NOTE This report is not available for PCA therapies See Given and PCA Dose Counters on page 96 and PCA Dose Graph on page 96 for reports specific to PCA therapies The total given report shows the amount of drug given since the date and time indicated which is the last time the counter was cleared man...

Page 96: ...ncluding those that were delivered locked out and stopped in progress To clear total given and or the dose counters 1 In the View Reports menu press U or D to highlight Given and PCA Dose Counters and press S 2 Press U or D until the counter you wish to clear is highlighted 3 Select Clear Given or Clear Doses to clear the counter This also updates the time and date on this screen PCA Dose Graph NO...

Page 97: ... Continuous Rate Continuous Rate Doses Step and Plateau Taper and Plateau PCA Dose Clinician Bolus To view the Delivery History and Pie Chart In the View Reports menu press U or D to highlight Delivery History and Pie Chart and press S Delivery Log The delivery log is a subset of the event log and contains specific information regarding delivery events The delivery log is maintained by the pump an...

Page 98: ...Library Summary The protocol library summary allows you to view information about the protocol library currently installed in the pump This screen tells you the name of the protocol library the revision and the number of protocols in the library To view the Protocol Library Summary In the View Reports menu press U or D to highlight Protocol Library Summary and press S Device Information The device...

Page 99: ...to unlock the keypad This step is necessary only if the keypad is not already unlocked WARNING Do not disclose the pump security codes or any other information that would allow the patient or unauthorized clinician complete access to programming and operating functions Improper programming could result in serious patient injury or death Do not leave the pump unattended while unlocked All programmi...

Page 100: ...amming could result in serious patient injury or death Do not leave the pump unattended while unlocked All programming functions are accessible while the pump is unlocked and improper programming could result in serious patient injury or death In the Advanced Tasks menu press U or D to highlight Patient Permissions and press S Priming Security On Off Setting this value to Off allows patients to pr...

Page 101: ... for Intermittent therapies without having to enter a security code To set patient permissions for delayed start security 1 Make certain the pump is stopped 2 In the Patient Permissions menu press U or D to highlight Delayed Start Security On Off and press S 3 Unlock the keypad 4 Press U or D to highlight On security code required or Off no security code required and select Save ...

Page 102: ...her the air detector is turned on or off If the air detector is turned on an alarm sounds when air is detected in the fluid path For certain therapies for example subcutaneous infusions it may be desirable to turn the air detector off WARNING If the air detector is turned off the pump does not detect air in the fluid path It is recommended that you periodically inspect the fluid path and remove an...

Page 103: ... be set to On or Off If this sensor is set to On and an upstream occlusion is detected an alarm sounds delivery stops and the display shows that there is an upstream occlusion An upstream occlusion is detected only when administration sets and bags are being used NOTE The pump does not test for an upstream occlusion when using a medication cassette reservoir even if the upstream occlusion sensor i...

Page 104: ...u to specify a high or low degree of response to pressure buildup in the downstream tubing When a downstream occlusion is detected an alarm sounds delivery stops and the display shows High Pressure NOTE The downstream sensor is always On To set the downstream sensor sensitivity 1 Make certain the pump is stopped 2 In the Air and Occlusions Settings menu press U or D to highlight Downstream Sensor ...

Page 105: ...able for Step delivery mode only Turning this setting On results in infusion notification screens 5 minutes before each automatic step up occurs To set the infusion alerts 1 Make certain the pump is stopped 2 In the Alarm Settings menu press U or D to highlight Infusion Alerts On Off and press S 3 Unlock the keypad 4 Press U or D to highlight Off or On and select Save Pump Stopped Alarm Type The p...

Page 106: ...ed 2 In the Alarm Settings menu press U or D to highlight Reservoir Low Trip Point and press S 3 Unlock the keypad 4 Press U or D to set the trip point to the desired volume and select Save Reservoir Low Alarm Type The reservoir low alarm type allows you to select either an Insistent and One Time Only alarm medium priority or a Non Insistent and Repeating alarm low priority to inform the user that...

Page 107: ...s S 3 Unlock the keypad 4 Press U or D to highlight One Time Only or Repeat Until Removed or Reset and select Save PM Reminder On Off If your facility establishes a maintenance program for the pump you can use the PM reminder on off option to program the pump to sound an alarm when it is time for preventive maintenance The message begins appearing on the date programmed and during every power up u...

Page 108: ...ettings menu press U or D to highlight PM Reminder and press S 2 PM Interval is highlighted see step 4 below to edit the settings PM Interval To edit the PM interval 1 Make certain the pump is stopped 2 In the Alarm Settings menu press U or D to highlight PM Reminder and press S 3 Unlock the keypad if necessary 4 PM Interval is highlighted Press S to edit it Press U or D to choose the number of mo...

Page 109: ...tings all protocol library information is lost To reset the pump to factory settings 1 Make sure the pump is stopped 2 In the Advanced Tasks menu press U or D to highlight Reset to Factory Settings and press S 3 Unlock the keypad 4 A screen appears that explains that you are about to erase the protocol library and pump settings Select Yes 5 The pump powers down and restarts in the continuous mode ...

Page 110: ...ower Close the battery door and turn the pump back on If the error code does not repeat Customer Service may suggest continued use of the pump If the error is persistent the pump must be returned for service NOTE Document the error numbers displayed on the system fault screen to help Customer Service identify the problem CAUTION If the power up results in an error message indicating that the proto...

Page 111: ...onal examples are Cassette Locked and Cassette Unlocked Alarm Help Screens Additional information may be displayed when certain alarms occur The help screens describe what you can do to try to solve the current problem that is causing the alarm 1 When an alarm occurs select Silence to quiet the alarm 2 If help screens are available for the alarm Help appears above the right soft key To view the he...

Page 112: ...it was lost Medium A parameter was being manually edited but it was not saved and the pump reverted to the home screen Select Acknowledge to clear the alarm and if appropriate edit the parameter and save AC adapter disconnected Low The AC adapter was disconnected and the pump is being powered by the 4 AA batteries or the rechargeable battery pack Select Acknowledge to clear the alarm or the alarm ...

Page 113: ... If appropriate start the pump Cannot start pump with a depleted battery Medium The battery power is too low to operate the pump To start delivery good batteries must always be installed even when an external source of power is connected Select Acknowledge to clear the alarm Install 4 new AA batteries or a fully charged rechargeable battery pack If appropriate start the pump Cannot start pump with...

Page 114: ... the pump before it was reattached and the pump s sensors are not able to detect the cassette type Remove the cassette and reattach it then verify the cassette type in the pump display If the alarm persists replace the cassette NOTE You must remove the cassette to continue Check for empty tubing or reservoir Pump stopped High The tubing beneath the pump may not contain fluid or the fluid container...

Page 115: ...d silence the alarm for 2 minutes then remove the obstruction and restart the pump NOTE To reduce the potential for a bolus delivery after an occlusion perform the following 1 Select Stop Pump to stop the pump 2 Close the distal clamp If the distal clamp is the cause of obstruction keep it closed and continue with step 4 3 Remove the obstruction 4 Detach the CADD medication cassette reservoir or C...

Page 116: ... adjustment to the next dose start time in order to keep the interval unchanged from the current date and time PCA dose cord button stuck Release or remove cord High The PCA remote dose cord button may be pressed down The pump is stopped and will not run Make sure nothing is pressing on the PCA remote dose cord button If the alarm persists remove the PCA remote dose cord to clear the alarm and con...

Page 117: ...tall 4 new AA batteries or a fully charged rechargeable battery pack To start delivery good batteries must always be installed even when an external source of power is connected If appropriate restart the pump Remove and reattach cassette High The pump has detected a damaged cassette Close the tubing clamp and inspect the cassette for damage The pump is stopped and will not run Replace cassette if...

Page 118: ...e rechargeable battery pack is not compatible with the pump Select Acknowledge to clear the alarm Remove the battery or batteries from service Install 4 new AA batteries or a fully charged rechargeable battery pack To start delivery good batteries must always be installed even when an external source of power is connected If appropriate start the pump Upstream occlusion Clear occlusion between pum...

Page 119: ... Do not immerse the pump in cleaning fluid or water Do not allow solution to soak in to 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 pump may damage the pump Do not clean the pump with acetone other plastic solvents or abrasive cleaners as damage to the pump may occur 1 Ensure that debris is not al...

Page 120: ...n properly should be confirmed following treatment Do not expose the pump directly to ultrasound as permanent damage to the electronic circuitry may occur Magnetic fields produced by MRI equipment may adversely affect the operation of the pump Remove the pump from the patient during MRI procedures and keep it at a safe distance from magnetic energy Use of this pump on patients monitored by electro...

Page 121: ...004 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 Electromagnetic Compatibility EMC Part 4 3 Testing and measurement techniques Radiated radio fre...

Page 122: ...n Revision 1 1 September 23 1998 USB org EN 1041 1998 Information supplied by the manufacturer with medical devices IEC TR 60878 2003 Graphical symbols for electrical equipment in medical practice EN 980 2003 Graphical symbols for use in the labeling of medical devices IEC 60529 2001 Degrees of protection provided by enclosures IP Code ...

Page 123: ...s greater than 1000 10 0 PCA Dose and Clinician Bolus Scroll Ranges Milliliters Milliliters Increment Max 0 05 50 PCA Dose and Clinician Bolus Scroll Ranges Milligrams Concentration Milligrams Concentration Milligrams mg mL Increment Max mg mL Increment Max 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 ...

Page 124: ...5 550 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 00 25 000 Military Time Military Time Conversion 12 Hour Time 24 Hour Time 12 Hour Time 24 Hour Time 12 00 am Midnight 00 00 12 00 pm Noon 12 00 1 00 am 01 00 1 00 pm 13 00 2 00 am 02 00 2 00 pm 1...

Page 125: ...ccessories Pump alarms High priority alarms Air in line 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 inval...

Page 126: ...p shuts off due to too low operating voltage Alkaline battery life with screen backlight intensity set to 3 These estimates are based on laboratory tests conducted at room temperature using new batteries Actual battery life varies depending on the battery brand shelf life temperature conditions delivery rate and frequency of screen display and backlighting It is recommended that new batteries be k...

Page 127: ...stimates are based on laboratory tests conducted at room temperature using a new CADD Solis rechargeable battery pack Actual battery life varies depending on temperature conditions delivery rate and frequency of screen display and backlighting It is recommended that new batteries be kept available for replacement PCA and Continuous delivery Rate mL hr Life hrs Volume mL 0 4 119 47 6 1 0 89 89 0 5 ...

Page 128: ...o occlusion alarm and Bolus volume at occlusion alarm Flow Rate mL hr Tubing Set Maximum Time to Occlusion Bolus at Occlusion Raw Test Data minutes Specification minutes Raw Test Data mL Specification mL 0 1 CADD medication cassette reservoir 21 7002 with CADD extension set 21 7045 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...

Page 129: ...p is being used to deliver critical or life sustaining medication the interruption in the delivery of medication could result in patient injury or death System delivery inaccuracies may occur as a result of back pressure or fluid resistance which depends upon drug viscosity catheter size and extension set tubing for example microbore tubing and placing the infusion reservoir and or pump above or b...

Page 130: ...h standard volume cassette tubing 500 mL hr with high flow volume cassette tubing Alarm disabled during priming Air In Line Delivery Specifications Common Delivery Specifications Reservoir volume 0 to 9999 Programmable in 1 mL increments Displayed in 0 1 mL increments Given 0 to 99 999 99 in 0 01 unit increments Res vol low trip point 1 to 999 mL in increments of 1 mL Res vol empty alarm Insistent...

Page 131: ... This allows for the pressure to stabilize before a possible alarm If the pressure stabilizes below the high pressure alarm threshold before the 2 second delay is complete the alarm will not occur Upstream occlusion sensor On or off NOTE The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs PCA Delivery Specifications Programming units If programmin...

Page 132: ...rom 0 01 to 0 5 mL 0 5 mL from 0 5 to 100 mL 1 0 mL from 100 to 1 000 mL Clinician bolus 0 mL to 50 mL or mg or mcg equivalent Delivery limit method Delivery limit Max doses per hour Not in use Delivery limit period 1 to 12 hours in increments of 1 hour Maximum delivery rate combined bolus and continuous rate 40 to 250 mL hr in increments of 1 mL KVO rate 0 mL hr or 0 1 mL hr Continuous Delivery S...

Page 133: ...rement 0 4 to 499 mL hr Infusion volume 1 to 9990 mL Step duration 15 min to 24 hr KVO rate 0 to 10 mL hr Step infusion alerts On or Off Taper Delivery Specifications Infusion volume 1 to 9990 mL Taper up 0 min to 99 40 hr min Taper down 0 min to 99 40 hr min Infusion duration 10 min to 99 50 hr min KVO rate 0 to 10 mL hr Plateau rate upper limit 0 1 to 500 mL hr ...

Page 134: ...eclaration Electromagnetic Immunity The CADD Solis pump is intended for use in the electromagnetic environment specified below The customer or user of the CADD Solis pump should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 8 kV contact 15 kV air ...

Page 135: ...OTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 ...

Page 136: ...to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference i...

Page 137: ...Rate Continuous Rate Dose Volume Infusion Volume Infusion Volume PCA Dose Dose Duration Initial Rate Taper Up PCA Lockout Dose Cycle Rate Increment Taper Down Delivery Limit Dose Rate Plateau Rate Infusion Duration Max Doses Hr Next Dose Step Duration Plateau Rate Infusion Duration KVO Rate KVO Rate KVO Rate KVO Rate KVO Rate Reservoir Vol Reservoir Vol Reservoir Vol Reservoir Vol Reservoir Vol St...

Page 138: ...ery History and Pie Chart Delivery Log Event Log Protocol Library Summary Device Information Advanced Tasks Step Down Step only Step Up Step only Give Clinician Bolus PCA only Patient Permissions Air and Occlusions Settings Alarm Settings Security Settings Start New Patient Start New Protocol Same Patient Delivery Hard and Soft Limits Reset to Factory Settings ...

Page 139: ...rip Point Reservoir Low Alarm Type Reservoir Empty Alarm Type PM Reminder On Off PM Reminder Interval Security Settings Keypad Security Keypad Code Clinician Code Admin Code Manual Programming Security Delivery Hard and Soft Limits Mode Settings PCA Continuous Rate PCA Dose PCA Lockout Delivery Limit Method Delivery Limit Period Delivery Limit Amount Max Doses Hr Max Delivery Rate Clinician Bolus ...

Page 140: ...ff On Numeric Format 1 234 56 Change Time and Date Time Format 12 00 00 AM PM Date Format Month Day Year View Advanced Tasks Patient Permissions Priming Security On Off On Delayed Start Security On Off On Air and Occlusions Settings Air Detector On Off On Air Detector Sensitivity Low Upstream Sensor On Off On Downstream Sensor Sensitivity Low Alarm Settings Pump Stopped Alarm Type Informational Re...

Page 141: ...0 mL hr Continuous Continuous Rate 0 1 mL hr KVO Rate 0 mL hr Intermittent Dose Volume 0 1 mL Dose Duration 2 Hrs 0 Min Dose Cycle 24 Hrs 0 Min Dose Rate 0 1 mL hr Next Dose current time KVO Rate 0 mL hr Step Infusion Volume 1 mL Initial Rate 0 4 mL hr Rate Increment 0 4 mL hr Plateau Rate 0 4 mL hr Step Duration 30 Min Infusion Duration 2 Hrs 30 Min KVO Rate 0 mL hr Taper Infusion Volume 24 mL Ta...

Page 142: ...ntinuous Rate Hard Max Soft Max 500 mL hr 0 1 mL hr Soft Min Hard Min 0 1 mL hr 0 1 mL hr Intermittent Dose Volume Hard Max Soft Max 1 000 mL hr 0 1 mL hr Soft Min Hard Min 0 1 mL hr 0 1 mL hr Dose Duration Hard Max Soft Max 24 Hrs 0 Min 24 Hrs 0 Min Soft Min Hard Min 24 Hrs 0 Min 1 Min Dose Cycle Hard Max Soft Max 96 Hrs 0 Min 96 Hrs 0 Min Soft Min Hard Min 96 Hrs 0 Min 10 Min Step Initial Rate H...

Page 143: ...ta The tests were performed per IEC 60601 2 24 standard Over long observation windows short term fluctuations have minimal effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have an increasing effect as represented by the mouth of the trumpet Being aware of system accuracy over various observation windows may be of interest ...

Page 144: ...iod Low rate 10 mL hr Intermediate rate 150 mL hr T min Epmax 4 78 Overall Error Epmin Percentage error of flow Observation Interval 0 1 2 3 4 5 6 7 8 2 5 0 11 19 31 T min Epmax Epmin Percentage error of flow Observation Interval 0 00 0 25 0 50 0 75 1 00 1 25 1 50 1 75 2 00 2 25 2 5 0 11 19 31 ...

Page 145: ...negligence or accident 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...

Page 146: ...rm type 107 Reservoir low alarm type 106 Reservoir low trip point 106 Alarm volume 89 Amber indicator light 12 13 80 86 110 Analgesics 9 Anesthetics 9 Autolock 21 B Backlight intensity 89 Batteries 78 129 AA batteries 14 16 78 79 AC adapter 12 15 78 Battery compartment 12 14 79 Battery life 126 Battery status 16 126 Installing batteries 79 Rechargeable battery pack 14 15 78 79 Symbols 10 11 16 C C...

Page 147: ...Display and sound settings 89 137 Alarm volume 89 Backlight intensity 89 Key beep on off 91 Numeric format 91 Sound theme 90 Dose cycle 52 55 Dose duration 52 55 Dose rate 52 55 Dose volume 52 54 Downstream occlusion sensor 14 Sensitivity 104 131 Drug 16 26 E Edit delivery settings 35 Epidural administration 9 Event log 98 Examples See Programming examples F Factory settings reset 109 G Given and ...

Page 148: ...umeric format 91 O Occlusion and air settings 102 139 Air detector on off 102 Air detector sensitivity 103 130 Downstream sensor sensitivity 131 Upstream sensor on off 103 Occlusion sensor Downstream 14 Upstream 14 P Patient permissions 100 139 Delayed start security on off 101 Priming security on off 100 PCA dose 10 38 41 45 46 PCA dose counters 96 PCA dose graph 96 PCA lockout 38 41 PCA therapy ...

Page 149: ...75 87 130 Reset reservoir volume 87 Reset to factory settings 109 Review pump settings 30 36 40 49 54 62 72 S Same patient new protocol 27 Screens and display 16 Security codes See Security settings Security settings 18 139 Admin code 18 24 Autolock 21 Clinician code 18 24 Customized settings 21 22 Entering security codes 21 Keypad code 18 23 Keypad security 23 Manual programming 25 Tables 19 20 S...

Page 150: ...133 Home screen 69 Infusion duration 70 Infusion volume 70 KVO rate 71 Plateau rate 70 Programming example 72 Reservoir vol 71 Set delayed start 31 Start time 71 Taper down 70 Taper up 70 Taper up 70 73 Tasks menu 88 Change time and date 92 Display and sound settings 89 Menu maps 137 Next dose start time 32 Prime tubing 83 Reset reservoir volume 87 Set delayed start 31 Set next dose start time 32 ...

Page 151: ......

Page 152: ...Mile Plains QLD 4113 Australia 61 0 7 3340 1300 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 2010 Smiths...

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