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Introduction and Safety

Manual 41018v0800

SIGMA Spectrum Infusion System

Revision B

Operator’s Manual

Conventions

 WARNING 

Indicates a potentially hazardous situation which, if not avoided, 
could result in death or serious injury. 

 CAUTION 

Indicates a potentially hazardous situation which, if not avoided, 
may result in minor or moderate personal injury or property 
damage. This word is used to also alert against unsafe 
practices.

NOTE:

Indicates supplemental information to accompany text.

Summary of Warnings and Cautions

General Warnings

 WARNING 

Motor Vehicle or Aircraft Use.

The SIGMA Spectrum Infusion Pump with Master Drug Library has 
not been tested or evaluated for use in motor vehicles or aircraft (for 
example, ambulance or MedFlight helicopter).

 WARNING 

Hyperbaric Chamber. 

The SIGMA Spectrum Infusion System has not been tested or 
evaluated for use in a hyperbaric chamber.

 WARNING 

Only Use the AC Power Adaptor Specified for this Equipment.

Using other AC Power Adaptors may cause personal injury or 
damage to equipment.

 WARNING 

Ensure Secure Mounting of Pump During Use and Transport.

During use and transport, securely mount Pumps to IV pole by 
centering the pole in the clamp and turning the mounting knob 
clockwise. To maintain IV pole stability, never exceed 210 cm (83 in) 
from floor to IV pole top and limit bag volume at this extended height 
to <1 liter (1000 cc).

 WARNING 

Battery Handling.

Do not short circuit battery terminals.

Do not disassemble or modify battery packs.

Do not dispose of batteries or battery pack in fire.

 WARNING 

Low Battery. 

Do not use battery operation or transport a patient when the Pump is 
in a low battery state.

Summary of Contents for 35700BAX2

Page 1: ...41018v0800 Rev B December 10 2014 Operator s Manual SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY 35700BAX2 Pump Operating Software Version 8 00 For use with Master Drug Library Version 8 0 ...

Page 2: ...nual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual 2014 Copyright Baxter Healthcare Corporation 711 Park Avenue Medina New York 14103 T 800 356 3454 F 585 798 3909 www sigmapumps com ...

Page 3: ...um Infusion System Illustrations 17 SIGMA Spectrum Infusion Pump Front View 18 SIGMA Spectrum Infusion Pump Front View with Door Open 18 SIGMA Spectrum Infusion Pump Rear View Without Battery 19 SIGMA Spectrum Infusion Pump Rear View with Battery Installed 19 SIGMA Spectrum Infusion Pump Display Features 20 Pump Icons 21 Keys Used to Program and Operate the Pump 22 Soft Keys 22 Hard Keys 23 Symbol...

Page 4: ...ions 48 Infusion Delivery Modes 49 Activating a Drug Library on a Pump with a Wireless Battery Module 49 Dose Error Reduction System DERS Programming 50 Secondary Infusion 58 Clearing the Secondary Infusion to Return to the Primary Infusion 63 Secondary Callback 64 Loading Dose 67 Bolus 69 Multi Step 70 Cyclic TPN 74 Dose Change or Rate Change of a Continuous Infusion 76 Changing the VTBI Without ...

Page 5: ...leted 116 Cleaning and Storage 117 Compatible Cleaners 117 Cleaning the Pump 118 Cleaning the Battery Module 120 Cleaning the AC Power Adaptor 120 Cleaning the Pole Clamp 121 Pump Handling Transport and Storage 122 Compatible IV Sets 123 Compatible Baxter IV Sets 123 Compatible Baxter IV Sets WARNINGS 127 Accessories 130 Tandem Carrier 130 Three Pump Carriers 130 Multi Pole 131 Double Rotating Pol...

Page 6: ...cclusion 150 Time to Occlusion Alarm 150 Bolus Volume 150 Appendix E Electromagnetic Compatibility 151 Emissions 151 Immunity ESD transient burst voltage disparity and magnetic field 152 Immunity Conducted and Radiated 154 Immunity Separation Distances 156 Appendix F Low Very Low Battery Alarm Instructions 157 Low Battery Alarm Instructions 158 Very Low Battery Alarm Instructions 159 Appendix G De...

Page 7: ...ibrary is suitable for a variety of patient care environments such as but not limited to hospitals and outpatient care areas The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming thereby helping to reduce errors The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professiona...

Page 8: ...bulance or MedFlight helicopter WARNING Hyperbaric Chamber The SIGMA Spectrum Infusion System has not been tested or evaluated for use in a hyperbaric chamber WARNING Only Use the AC Power Adaptor Specified for this Equipment Using other AC Power Adaptors may cause personal injury or damage to equipment WARNING Ensure Secure Mounting of Pump During Use and Transport During use and transport secure...

Page 9: ...p when storing the Pump for extended periods WARNING Proper Disposal Required To dispose of this device or the associated administration sets adhere to local state federal and or other governing regulations WARNING Magnetic Fields The SIGMA Spectrum Infusion System is not designed to be MRI compatible nor is it intended to be used in this manner Strong magnetic fields those beyond the level tested...

Page 10: ... upstream or downstream occlusions inability to charge battery and or decreased battery life WARNING Confirm Safe Operation Never operate the SIGMA Spectrum Infusion Pump unless all of the following safe operations are being practiced Always confirm safe accurate Pump operation by Ensuring that IV sets or container vents are properly functioning that tubing clamps are in the proper positions and t...

Page 11: ...the correct Drug Library is installed on the deployed Pumps Before implementation clinical users at each facility must thoroughly test and validate their Drug Library per their facility s procedure to ensure configuration and workflow reflect clinical practice WARNING Use the Specified Manufacturer s IV Set A label located on the top of the Pump indicates the specific type of IV tubing that the Pu...

Page 12: ... clamps Only the slide clamp on the pumping section or on the section with the main roller clamp should be used for pumping operation and clamp detection Other slide clamps on the set must be used with the set and need to be observed and controlled by the user To prevent free flow the slide clamp on the tubing that is loaded into the Pump should be used to open the Pump door 9 Blood sets with both...

Page 13: ...iff materials Using a dropped damaged dirty or wet Pump Pressurizing IV bags Non vented IV sets with rigid non vented containers Vents on sets or burettes left in the closed position when they should be open Using Minidrip chambers for flow rate settings greater than 200 mL hr Doing so may influence flow rate accuracy and cause air in line or upstream occlusion alarms Laying the IV container flat ...

Page 14: ...sition To open the Pump door the IV set s slide clamp must first be closed thus providing set based anti free flow protection Do not open the slide clamp when the door is open or during and after IV set unloading This can cause dangerous uncontrolled free flow to occur During IV container changes always close the set s roller clamp When the set is in the Pump and the door is closed the slide clamp...

Page 15: ...Pump with appropriate flow rate VTBI Volume To Be Infused patient weight and occlusion alarm limits Prior to connecting to patient prime IV set following the standard gravity priming instructions included with the administration set then close roller clamp load IV set open slide clamp and roller clamp to avoid possible bolus 0 2 mL that would result from a door opening set loading event If the Pum...

Page 16: ...based on specific test conditions The analytical related conditions are A distance of 1 2 m 48 in from the point of the downstream occlusion to the SIGMA Spectrum Infusion System s Downstream Occlusion sensor approximately the distance from the IV administration set s exit from the pumping channel to the point of occlusion The 1 2 m 48 in test administration set contained one Y injection site no f...

Page 17: ...ntained at the intended rate whenever the Pump door is open and when the set is outside of the Pump WARNING Radio Frequency Interference The SIGMA Spectrum Infusion System meets the electromagnetic compatibility EMC requirements as specified in the International Electrotechnical Commission s IEC 60601 1 2 2001 09 standard for emissions and immunity There may be potential difficulties if the Pump i...

Page 18: ... not closed above the Pump and respond appropriately to all primary and secondary check flow prompts Small bore catheters or needles may cause excessive back pressure at high flow rates Size the catheters according to expected flow rate and fluid viscosity CAUTION Upstream Backcheck Valve Use When connecting a secondary ensure the primary administration set contains an upstream backcheck valve CAU...

Page 19: ...ay If display abnormalities are observed discontinue use of the Pump and refer servicing to qualified service personnel at your facility or return the Pump to Baxter for service CAUTION Unrecoverable System Error If unable to clear a fault condition during a system error occurrence discontinue using the Pump Refer to qualified service personnel at your facility or return the Pump to Baxter for ser...

Page 20: ...to greater than or equal to 100 watt incandescent bulb within 30 5 cm 1 ft above the Pump s keyhole load point 1 may affect the Pump s ability to recognize the blue slide clamp during set loading To prevent alarms or continuous system errors Increase the distance between the Pump and the light source Move the Pump to an adjacent location CAUTION Avoid Overheating When operating the Pump keep out o...

Page 21: ...ose of Properly The SIGMA Spectrum Infusion System contains a lithium ion rechargeable battery pack and a replaceable battery cell Improper disposal can result in hazards to humans or environmental conditions Do not dispose of batteries in trash or in fire These batteries are recyclable and should be disposed of properly Contact an authorized disposal center or return battery to Baxter for disposa...

Page 22: ...s per federal state and local regulations for biohazard waste disposal CAUTION Perform Preventive Maintenance Annually Pumps should be tested for proper performance annually and also whenever damage from drops fluid intrusion and other causes is suspected See SIGMA Spectrum Infusion System Service Manual P N 41019v0800 for complete information ...

Page 23: ...ong with associated Care Areas and infusion delivery parameters for each drug SIGMA Spectrum Infusion System Master Drug Library User Manual P N 41020v080 SIGMA Spectrum Infusion System Operator s Manual P N 41018v0800 SIGMA Spectrum Infusion System Service Manual P N 41019v0800 SIGMA Spectrum Infusion System Illustrations The illustrations in this section present the various features of the SIGMA...

Page 24: ...6 2 Door 3 Pump display See Figure 7 4 Soft keys 5 Hard keys 6 IrDA port Figure 3 SIGMA Spectrum Infusion Pump Front View 1 Tubing from IV container 2 Slide Clamp and tubing loading guide 1 3 Tubing channel 4 Tubing guides 2 3 and 4 These loading guides are indicated by numbers highlighted in red circles 5 Tubing to patient 6 Door latches Figure 4 SIGMA Spectrum Infusion Pump Front View with Door ...

Page 25: ...attery pin set 3 Drainage channel 4 Screw holes for cord retainer two screw holes above and one below the plug adaptor 5 6 pin plug adaptor 6 Speaker vent 7 Battery pocket 8 Pump side adaptor 9 Thumb screw 10 Slide Clamp keyhole color sensor assembly Figure 5 SIGMA Spectrum Infusion Pump Rear View without Battery 1 Wireless Battery antenna 2 Battery release 3 Battery module Figure 6 SIGMA Spectrum...

Page 26: ...more information see Pump Icons on page 21 3 Infusion Running screen status indicator 4 Soft key labels For more information see Keys Used to Program and Operate the Pump on page 22 5 Power status For more information see Pump Icons on page 21 6 Keypad lock status For more information see Keypad Lock on page 100 Figure 7 SIGMA Spectrum Infusion Pump Display Features 1 2 3 4 5 6 ...

Page 27: ...ing Red and White background A new Drug Library has been received and is ready for activation Keypad is locked Setting has been assigned in the Master Drug Library to the currently selected drug Callback feature is active Secondary infusion is active Primary infusion is active The AC Adaptor is connected and the Wireless Battery Module is being charged Battery segments bars indicate battery charge...

Page 28: ...s feature is available for Amount Time only hold Press to place the Pump in Standby mode info settings Press to select additional Pump features related to alarm settings display settings or information view multi step Press to access the Multi Step Programming mode no Press to indicate a negative acknowledgement of a prompt options menu Press to access the User Options and Biomed Options selection...

Page 29: ...n BASIC Zero key Displays the BASIC Mode CAUTION screen informing the user that BASIC Mode operation does not observe library limits During programming this key allows entry of the number zero ALPHANUMERIC 1 9 A Z and the decimal point key Programming screens enable numbers and drug selection screens enable letters Press alphanumeric keys once twice or three times to select corresponding letters o...

Page 30: ... against ingress of water with harmful effects Consult accompanying documents Read all instructions before using ISO 15223 1 CLASS II EQUIPMENT IEC 60417 5172 TYPE BF APPLIED PART IEC 60417 5333 Direct Current IEC 60417 5031 Alternating Current IEC 60417 5032 Recyclable dispose of properly ISO 7000 1135 Non ionizing electromagnetic radiation IEC 60417 5140 Classified Medical Electrical Equipment C...

Page 31: ...s used on the SIGMA Spectrum Infusion System NOTE The actual label may vary with laser mold Direction of Flow Company ID Located on the back of the Pump case Power Located on the back of the Pump case Certification Located on the back of the Pump case Serial Number Located on the bottom of the Pump case Tubing ID Located on the top of the Pump case ...

Page 32: ...andard Battery Located on the back of the battery module Wireless Battery 802 11b g Located on the back of the battery module Battery Caution Located on the front of the battery module Company ID Located on the back of the battery module Wireless Battery Module Located on the side of the battery module ...

Page 33: ...ration Battery Replacement CAUTION Recyclable Battery Pack Dispose of Properly The SIGMA Spectrum Infusion System contains a lithium ion rechargeable battery pack and a replaceable battery cell Improper disposal can result in hazards to humans or environmental conditions Do not dispose of batteries in trash or in fire These batteries are recyclable and should be disposed of properly Contact an aut...

Page 34: ...ally Pumps should be tested for proper performance annually and also whenever damage from drops fluid intrusion and other causes is suspected See SIGMA Spectrum Infusion System Service Manual P N 41019v0800 for complete information To check the correct functioning of alarms and operational safety of the device have preventive maintenance performed by qualified service personnel Refer to the SIGMA ...

Page 35: ...end caps 2 Save all packaging materials for reuse This is advised in the event that product repair or warranty replacement is necessary 3 Discard the desiccant package 4 A battery tab isolates the battery voltage from the Pump during transportation and distribution Remove the tab prior to charging the Pump s battery or operating the Pump To remove the battery tab pull the tab away from the Battery...

Page 36: ...y cause personal injury or damage to equipment CAUTION Handle AC Power Adaptor With Care Do not drop the AC Power Adaptor It is an electronic device and may break if dropped Do not twist or pull the AC Power Adaptor or cord at an angle This could bend the prongs Do not unplug the AC Power Adaptor by pulling on the power cord Do not connect two or more AC Power Adaptors side by side narrow side tou...

Page 37: ...aight direction Charging the Battery WARNING Low Battery Do not use battery operation or transport a patient when the Pump is in a low battery state WARNING Battery Handling Do not short circuit battery terminals Do not disassemble or modify battery packs Do not dispose of batteries or battery pack in fire WARNING Battery Removal Do not detach the battery during patient therapy Never touch the pat...

Page 38: ...er Adaptor is plugged into a powered outlet and is connected to the Pump It is not necessary to power on the Pump to charge the battery Ensure that the battery is fully charged prior to first use The approximate time to initially charge the battery is as follows Standard Battery charge time 12 hours Wireless Battery Module charge time 16 hours For battery power and capacity specifications see Appe...

Page 39: ...use the arrow soft key to select the desired tone and press OK Standby hr min Set the length of time to keep the Pump in Standby or Hold after setup of the infusion has been completed Settings are from 00 01 to 99 59 hr min Setting the value to 00 00 or Infinite results in an infinite Hold period Near Empty alert When enabled a Near Empty alert is displayed when 30 minutes or less of infusion rema...

Page 40: ...s approximately 400 mW when set to maximum brightness therefore battery life is maximized when the backlight is set to Off To adjust display brightness 1 Access the User Options menu screen From the Care Area selection screen press the options menu soft key Then use the arrow soft keys to select User Options and press OK From the Infusion Running screen press the info settings soft key 2 Using the...

Page 41: ...he Infusion Information screen identifies the infusion specific primary and secondary bag parameters that are not otherwise displayed on the Setup screen The information includes the following information for each bag if programmed audio level Near Empty Alert status primary only pressure setting KVO rate primary only and primary siphoning alert or secondary complete alert status secondary only Hi...

Page 42: ...tery Charge To maintain battery charge keep the Pump s AC Power Adaptor plugged into a powered outlet whenever possible including when the Pump is not in use 1 Mount the Pump on an IV pole by holding the Pump in one hand centering the pole in the clamp and with the other hand turning the mounting knob clockwise When using a three pump carrier avoid resting the Pump on the carrier plate Attach to t...

Page 43: ...alfway or to the fill IV line located within the drip chamber 5 Prime the IV set by opening the roller clamp half way and slowly prime the tubing As fluid is flowing invert and tap the upper backcheck valve and Y injection sites until all air is removed 6 When the IV tubing is completely primed position and close the slide clamp halfway between the upper Y injection site and the closed roller clam...

Page 44: ... expected flow rate and fluid viscosity NOTE Follow all loading steps as stated when reloading an IV set To load an IV set 1 Inspect the section of the IV set below the slide clamp that is to be loaded or reloaded into the Pump Ensure it is free of kinks bends or creases WARNING Do Not Reuse Tubing Do not reload pumped on tubing the tubing segment previously used in the pumping channel into the pu...

Page 45: ...emain in the keyhole during set loading NOTE Tubing should now be in front of the loading channel and not behind the door See Figure 14 WARNING IV Set Loading Load tubing directly from the slide clamp to the top of the tubing channel Confirm the tubing from the IV container enters the back of the slide clamp and exits the front of the slide clamp prior to loading the tubing section into the Pump c...

Page 46: ...bing follows the Direction of Flow diagram Ensure that the tubing is routed from the front of the slide clamp directly into the top of the tubing channel Load the tubing without slack This prevents the tubing from getting caught in the door or from being loose in the Pump Do not use excessive force when inserting the administration set into the channel 9 Push the tubing into load guide 2 and confi...

Page 47: ...tem Pump Operating Software Version 8 00 Operator s Manual For Use With MDL Version 8 0 The tubing is properly loaded when the screen displays three green bars and check marks for all four loading guides See Figure 16 Figure 16 IV Set Loaded in the Tubing Channel ...

Page 48: ...ING Bolus When the administration set is loaded the door is closed and the slide clamp is removed a fluid bolus will occur maximum of 0 1 mL 12 Remove and open the slide clamp from the keyhole by holding the tubing down on both sides of the keyhole with one hand and removing the slide clamp up and out with the other hand The slide clamp is open when it moves freely on the tubing Figure 17 Proper D...

Page 49: ...m the IV container to the Pump and from the Pump to the patient Follow the facility s procedure for labeling IV tubing 15 Attach the IV set to the patient access site 16 Prime all additional IV sets or add ons prior to attaching to the existing infusion If another IV set or add on is added to the existing infusion below the Pump the Pump is unable to detect any air that may be present in the addit...

Page 50: ... can safely be opened If gravity flow is to be used the Pump door will be open or the set will be outside the Pump Verify gravity flow is maintained at the intended rate whenever the Pump door is open and when the set is outside of the Pump To unload an IV set 1 If the Pump is running press STOP to stop the infusion 2 Close the roller clamp to prevent free flow 3 Push the slide clamp into the keyh...

Page 51: ...ctrum Infusion System Pump Operating Software Version 8 00 Operator s Manual For Use With MDL Version 8 0 NOTE To prevent the slide clamp from inadvertently opening do not unload the IV tubing from the top of the Pump Figure 19 Remove the IV Set ...

Page 52: ...luid flow back into the primary container CAUTION Upstream Backcheck Valve Use When connecting a secondary ensure the primary administration set contains an upstream backcheck valve 2 Use a primary set with an upper Y injection site and backcheck valve 3 Ensure the roller clamp on the secondary IV set is closed 4 Connect the secondary set to the primary set s upper Y injection site Lower the prima...

Page 53: ...o closed clamps or kinks in the tubing that might prevent flow and that drops are flowing in the drip chamber See Figure 20 Secondary Check Flow Error Prevention does not apply to Anesthesia and OR Care Areas During Secondary setup a pop up displays to verify that the Secondary VTBI Volume To Be Infused equals the secondary bag volume See Figure 21 The screen displays to verify that drops are fall...

Page 54: ...vents unauthorized activation of specific key entries For information on using the Keypad Lock feature see Keypad Lock on page 100 Infusion Programming Options The SIGMA Spectrum Infusion System provides two options for programming infusions Dose Error Reduction System DERS For information on programming the Pump using DERS see Dose Error Reduction System DERS Programming on page 50 BASIC Mode For...

Page 55: ...between each step Each step must be within the Drug Library defined dose rate limit Activating a Drug Library on a Pump with a Wireless Battery Module Activating a Drug Library is the process of replacing the current Drug Library or deploying a new Drug Library The Pump will receive a new Drug Library any time the Pump is on and at the Drug Library check interval specified in the Drug Library When...

Page 56: ...ts or container vents are properly functioning that tubing clamps are in the proper positions and that tubing is free from kinks or signs of collapse outside the Pump to prevent undetected upstream occlusions Observing the drip chamber to verify that there is no flow from the fluid container when the Pump is stopped Ensuring the drip rate approximates the Pump s flow rate during RUN operation Ensu...

Page 57: ...e CAUTION Confirm Audio Operation Listen for beeps when pressing keys If sound is not heard discontinue use of the Pump and refer servicing to qualified service personnel at your facility or return the Pump to Baxter for service CAUTION Confirm Display Operation Regularly observe the Pump s display If display abnormalities are observed discontinue use of the Pump and refer servicing to qualified s...

Page 58: ... See Figure 29 Select the drug from the Drug Library using the keypad press the alphanumeric hard key s labeled with the desired letter s to enter the first two letters of the drug name If an incorrect letter is displayed use the back arrow soft key to clear and reenter the correct letter See Figure 30 All drug names beginning with those two letters appear Figure 28 New Patient Screen Figure 29 Se...

Page 59: ...he facility s procedure to request the drug be added to the Pump NOTE After selecting a drug and concentration if applicable a clinical advisory may display A clinical advisory is configured in the Drug Library by drug It is an advisory that displays important information related to the delivery of a drug 6 Move the cursor to the correct drug concentration if more than one is offered and press OK ...

Page 60: ...nt weight if applicable 11 Enter the dose or flow rate value and press OK 12 Enter the VTBI Volume To Be Infused in mL 13 Verify that the VTBI equals the volume in the container and press OK 14 Confirm the calculated infusion time 15 Confirm the Total given mL value or press the clear total soft key to erase it NOTE VTBI counts down to zero while Total given counts from zero up 16 Review the value...

Page 61: ... may be exceeded by pressing OK followed by pressing the yes soft key to accept the dose rate displayed in the dialog box If the values are accepted they will appear in red on the Infusion Running screen Hard dose or mL hr limits is an alert that the dose or the mL hr rate has been programmed to exceed the facility s pre configured hard limits in the Drug Library or that the programming exceeded t...

Page 62: ... Anesthesia or OR and cannot be changed 17 After selection and review of all values select one of the following actions To start the infusion ensure that the slide clamp and roller clamp are open and press RUN To put the Pump in Standby mode press the hold soft key To set up a secondary infusion enabled using the Drug Library press the program secndry soft key For instructions on setting up a seco...

Page 63: ...the tubing outside of the Pump Drops are flowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable WARNING Manually Stopping the Pump If the Pump cannot be stopped by pressing the RUN STOP key Close the roller clamp below the Pump Insert the slide clamp into the keyhole Push the slide clamp down until the door opens To change the rate ...

Page 64: ...he infusion Secondary Infusion To program a secondary infusion 1 Prepare the IV sets and container for a secondary infusion using the steps in Secondary Infusion Setup on page 46 2 Follow the steps for programming the primary bag infusion as described in either Dose Error Reduction System DERS Programming on page 50 or BASIC Mode on page 94 NOTE The SIGMA Spectrum Infusion Pump does not deliver a ...

Page 65: ...ary bag See Figure 41 5 If the Pump is running press STOP See Figure 42 The Pump Stopped screen will appear 6 On the Pump Stopped screen press the program pri sec soft key See Figure 43 The Setup screen appears 7 On the Setup screen press the program secndry soft key See Figure 44 8 If the drug is to be delivered using the DERS select the drug from the Drug Library Figure 41 Programmed Primary Set...

Page 66: ... the desired drug name and press OK See Figure 45 9 Press OK to select the secondary bag or press the arrow soft keys to change to the primary bag if needed See Figure 46 10 Confirm the values on the Setup screen Confirm the drug and concentrations are correct if selected Enter all required values and press OK after each entry NOTE Secondary VTBI should equal the secondary bag volume to avoid infu...

Page 67: ...lly extending the hanger Open the secondary roller clamp Press RUN to begin the secondary infusion 12 Once RUN is pressed the infusion will start and the Secondary Check Flow screen is displayed Confirm there are no drops falling in the primary drip chamber and there are drops falling in the secondary drip chamber See Figure 48 If the yes soft key is pressed the Secondary infuses as programmed unt...

Page 68: ...ed apply clamp to primary IV line above upper Y injection site see Figure 51 and press OK to confirm primary IV line is clamped See Figure 52 NOTE If the primary IV line is clamped the secondary infuses until completion and the rate will decrease to a KVO Keep Vein Open rate with alarm See Figure 53 13 At the completion of the secondary infusion if secondary callback has been applied the Secondary...

Page 69: ...ing to prevent any remaining drug in the secondary bag from being delivered at the primary delivery rate Upon completion of the secondary infusion and once the transition is made to the primary infusion a Primary icon one IV bag replaces the Secondary icon two IV bags on the Infusion Running screen 17 In the event the secondary IV bag is still attached confirm flow from primary drip chamber yes no...

Page 70: ... appears 7 To start the infusion press RUN Once RUN is pressed the infusion will start and the Primary Check Flow screen is displayed Check the flow and confirm All clamps are open There are no kinks or collapses in the tubing outside of the Pump Drops are flowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling i...

Page 71: ...ring secondary infusion Press the yes soft key to receive a callback at the end of the infusion Press the no soft key to automatically transition to the primary infusion If NEVER The Pump will automatically transition to the primary infusion upon completion of the secondary infusion To select Secondary Callback 1 When finished programming a secondary infusion if Secondary Callback is enabled as op...

Page 72: ...omplete notification screen will display See Figure 59 2 Press STOP 3 Select the infusion Press the SECONDARY soft key to return to the secondary setup screen This allows reprogramming of the last secondary infusion or programming with a new drug Press the review PRIMARY soft key to return to the primary infusion See Figure 60 After reviewing the primary program if the primary IV line is clamped r...

Page 73: ... and limits can be assigned to a drug in the Drug Library To program a loading dose 1 If the drug has been configured in the Drug Library to allow a loading dose a prompt is displayed after the drug has been selected See Figure 61 If the yes soft key is pressed the Loading Dose Setup screen is displayed See Figure 62 If the no soft key is pressed the Primary Setup screen is displayed NOTE The load...

Page 74: ...the primary program 5 To start the infusion ensure that the slide clamp and roller clamp are open and press RUN to start the delivery of the Loading Dose Once RUN is pressed the infusion will start and the Primary Check Flow screen is displayed Check the flow and confirm All clamps are open There are no kinks or collapses in the tubing outside of the Pump Drops are flowing in the drip chamber Note...

Page 75: ... value will increase Observe the Loading Dose Infusion Running screen on the Pump At the completion of the Loading Dose transition to the Primary Infusion rate is automatic Bolus A Bolus is a higher dose of a drug and can be delivered throughout the infusion A bolus is configured per drug in the Drug Library but is always available in BASIC mode A bolus can be programmed while the Pump is stopped ...

Page 76: ...g Library defined Dose Rate limits WARNING Do Not Exceed Total Volume To prevent Air in Line ensure the total VTBI of all the steps in a multi step program does not exceed the total volume contained in the IV bag Multi Step Programming is allowed when programming in one of the following DERS for drugs configured with the following delivery bag Primary Only Multi Step only available during primary ...

Page 77: ... the primary bag when a secondary program exists in memory NOTE If the drug has been configured in the Drug Library as a Primary Only Multi step infusion bag selection will be bypassed and the Multi Step Program setup screen will be displayed See Figure 66 NOTE Multi Step Program is not available as a secondary infusion 5 Enter the infusion parameters as described in the BASIC or DERS programming ...

Page 78: ... key to navigate to the step indicator bar located at the top of the setup screen Then using the left and right arrow soft keys move from step to step NOTE A one second delay exists from the time a step is selected when its setup value is displayed to allow rapid scrolling along the step bar To change any setup value when the Pump is stopped press the review or program pri sec soft key and navigat...

Page 79: ...th the program step indicator screen See Figure 68 The Pump will automatically advance to programmed steps while infusing NOTE Any value missing within the program is identified in a popup message when the user starts the Pump The program is complete when all programmed steps have been delivered The program schedule automatically resets itself and may be restarted without entering or re entering a...

Page 80: ...e desired step in the step bar NOTE Press the clr step soft key The last step of the program is the only step that can be cleared Cyclic TPN Cyclic TPN delivers TPN Total Parenteral Nutrition over a prescribed period of time in an automatic ramp up infusion rate to a main rate before tapering down This process increases the delivery rate at the start of an infusion and decreases the delivery rate ...

Page 81: ... and the Primary Check Flow screen is displayed Check the flow and confirm All clamps are open There are no kinks or collapses in the tubing outside of the Pump Drops are flowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling in the drip chamber press the yes soft key If no drops are falling press the no soft ke...

Page 82: ...During a Continuous Infusion if the dose or rate change exceeds the limits defined in the Drug Library a dialog box is displayed See Prompts that may appear during programming on page 55 To change dose without stopping the Pump 1 Press the dose change soft key See Figure 73 2 The current dose is displayed along with the dose soft limits Observe the displayed dose soft limits See Figure 74 3 Enter ...

Page 83: ...e the change in the mL hr rate based on the new dose entry 6 Press RUN to begin delivery at the new dose rate To change rate mL hr without stopping the Pump 1 At the Infusion Running screen press the rate change soft key See Figure 76 2 Observe the displayed mL hr soft limits See Figure 77 3 Enter a new mL hr flow rate See Figure 77 4 Press OK to confirm new flow rate See Figure 77 If soft limits ...

Page 84: ...the new flow rate Changing the VTBI Without Stopping the Pump To change VTBI without stopping the Pump 1 At the Infusion Running screen press the review edit VTBI soft key See Figure 78 2 At the Review screen press the edit VTBI soft key See Figure 79 3 Enter new value and verify the VTBI is equal to or less than the volume in the container See Figure 79 4 Press OK to confirm VTBI See Figure 79 Fi...

Page 85: ... 00 01 to 12 00 hr min for the delay run parameter and press OK 2 After the infusion programming is complete and the set is loaded press RUN to begin the infusion delay timer The delay running screen is displayed with the remaining delay time shown in a flashing format 3 When the delay time period expires the Pump begins delivery of the programmed infusion Primary Check Flow will display 4 An inac...

Page 86: ... 4 Press RUN to start the delay timer Confirming Weight and BSA The Weight or BSA confirmation screen set up in the Drug Library requires the patient weight or BSA parameter to be re entered to confirm that the value was entered correctly If the weight or BSA values do not match the Values Differ popup message is displayed Press OK and enter an accurate value See Figure 80 Also see Figure 81 NOTE ...

Page 87: ...using the keypad Press the alphanumeric hard key s labeled with the desired letter s to enter the first two letters of the drug name All drug names beginning with those two letters appear 3 If the selected drug has modifiers scroll to the desired modifier and press OK NOTE A Modifier is used to differentiate drug therapies on the Pump based on dose modes concentrations limits or configuration sett...

Page 88: ...Secondary Check Flow screen is displayed Check the flow and confirm All clamps are open There are no kinks or collapses in the tubing outside of the Pump Drops are flowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling in the drip chamber press the yes soft key If no drops are falling press the no soft key and f...

Page 89: ... mL hr rate while running press the rate change soft key and enter the new rate To program a Standard Concentration Drug Amount mL The standard concentration may not be changed at the Pump For example 4 mg mL 1 Enter drug amount Press OK 2 Confirm standard concentration and press OK See Figure 86 Also see Figure 87 NOTE VTBI is automatically calculated and displayed NOTE After RUN is pressed the V...

Page 90: ...lowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling in the drip chamber press the yes soft key See Figure 90 If no drops are falling press the no soft key and follow the screen prompts See Figure 90 NOTE If additional action is required To display infusion status while the Pump is infusing press the review sof...

Page 91: ...UN is pressed the VTBI cannot be edited in any Amount Time infusion The CONFIRM ADMIXTURE dialog box is displayed Press the yes soft key to confirm See Figure 95 3 Enter patient s weight or BSA if required Press OK See Figure 96 4 Enter duration of infusion Press OK See Figure 97 Dose if weight or BSA based is calculated and displayed See Figure 98 Figure 90 Primary Check Flow Screen Figure 91 Inf...

Page 92: ...g in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling in the drip chamber press the yes soft key See Figure 99 If no drops are falling press the no soft key and follow the screen prompts See Figure 99 NOTE If additional action is required Figure 96 Enter Patient Weight or BSA See important note on page 81 Figure 97 E...

Page 93: ...id volume VTBI in the container after subtraction of the priming volume This feature helps prevent early container depletion which may result in air in line alarms at the end of the primary infusion The infusion rate remains the same NOTE The Pump does not prime the IV set Priming needs to be done manually See Preparing and Priming an IV Set on page 36 To adjust the priming volume 1 Follow the dis...

Page 94: ...at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling in the drip chamber press the yes soft key If no drops are falling press the no soft key and follow the screen prompts Line Flush Line Flush feature allows delivery of any residual drug volume remaining in the IV container of a primary Amount Time infusion The Line Flush feature is enabled ...

Page 95: ...ill deliver the Line Flush amount at the mL hr rate of the previous infusion NOTE If additional action is required To change the line flush volume mL after entering and confirming it press the clear amount soft key 4 To start the infusion ensure that the slide clamp and roller clamp are open and press RUN Once RUN is pressed the infusion will start and the Primary Check Flow screen is displayed Ch...

Page 96: ... falling in the drip chamber press the yes soft key If no drops are falling press the no soft key and follow the screen prompts The volume remaining and an indicator that the IV line is being flushed are displayed See Figure 106 Line Flush will continue until the entered flush volume has been delivered or the air in line detector senses air See Figure 107 Figure 106 Primary Line Flush Status Scree...

Page 97: ...aining in the IV container of a secondary Amount Time infusion Line Flush is available for secondary infusions when the Secondary Callback feature is set to Required or Optional in the Drug Library Line Flush infuses at the same rate as the last programmed infusion rate Line Flush feature may be repeated up to three times Line Flush volume can be set to between 1 mL and 100 mL Line Flush is only a...

Page 98: ... ensure that the slide clamp and roller clamp are open and press RUN Once RUN is pressed the infusion will start and the Secondary Check Flow screen is displayed Check the flow and confirm All clamps are open There are no kinks or collapses in the tubing outside of the Pump Drops are flowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if appli...

Page 99: ...a Select Infusion screen displays to return to the Secondary Setup or Review Primary infusion See Figure 113 Changing the Rate of an Amount Time Infusion NOTE During an Amount Time Infusion a dialog box is displayed if the limits defined in the Drug Library for the selected drug are exceeded Values exceeding the Soft Limits can be accepted by pressing the yes soft key or declined by pressing the n...

Page 100: ... continuous infusion where Drug Library limits do not exist BASIC mode allows the user to manually specify a dose mode rate volume time or other parameters for the infusion Safety features available in BASIC mode are Primary Check Flow Secondary Check Flow and Single Step Rate or Dose Change When the Pump is running in BASIC BASIC MODE appears on a red background in the title bar of the Pump displ...

Page 101: ...ft key to retain the previously programmed infusion values See Figure 116 3 Press the arrow soft keys to select the Care Area and press OK See Figure 117 4 Using the keypad enter the letters BA select BASIC and press OK See Figure 118 Figure 116 New Patient Screen Figure 117 Select Care Area Screen Figure 118 Selecting BASIC at Drug Identification Screen ...

Page 102: ...s OK See Figure 120 Also see Figure 121 If a dose mode is selected entering a concentration will be required 7 To enter a concentration press the arrow soft keys to select a unit of measurement for example mg mcg g and so forth Press OK See Figure 122 Figure 119 BASIC Mode Bag Selection Screen Figure 120 BASIC Mode Dose Rate Selection Screen Figure 121 Arrow Soft Keys used to scroll through Dose M...

Page 103: ...ter the VTBI Volume To Be Infused in mL 13 Verify the VTBI equals the volume in the container and press OK 14 Confirm the calculated infusion time 15 Confirm the Total given mL value or press the clear total soft key to erase it NOTE VTBI counts down to zero while Total given counts from zero up 16 To start the infusion ensure that the slide clamp and roller clamp are open and press RUN to begin t...

Page 104: ...s the no soft key and follow the screen prompts Placing the Pump in STANDBY Hold Place the Pump in standby to prevent the Inactivity Alarm for the period of time specified in Alarm Settings in the menu option The default setting is set to an infinite period of time however this value may be changed from 1 minute up to 99 hours and 59 minutes To place the Pump in standby 1 Load the set and complete...

Page 105: ...clamp are open and press RUN Once RUN is pressed the infusion will start and the Primary Check Flow screen is displayed Check the flow and confirm All clamps are open There are no kinks or collapses in the tubing outside of the Pump Drops are flowing in the drip chamber Note at very low rates it may take several minutes to see drops Vents are open if applicable If drops are falling in the drip cha...

Page 106: ...e injury to the patient Automatic keypad lock When configured in the Drug Library the keypad will lock automatically by activating the Auto Keypad Lock feature by Care Area The keypad will lock 60 seconds after the RUN key is pressed To manually lock the keypad While the Pump is infusing enter the keypad lock code 429 A popup message appears briefly indicating that the keypad has been locked See F...

Page 107: ...d is unlocked while reviewing setup and the Pump is not stopped the keypad will automatically relock upon returning to the Infusion Running screen NOTE Pressing the STOP key while the keypad is locked will not stop the Pump To stop the Pump re enter the keypad lock code and press STOP To view infusion setup while the keypad is locked Press the review soft key or the review edit VTBI soft key No va...

Page 108: ...d service personnel at your facility or return the Pump to Baxter for service CAUTION Confirm Display Operation Regularly observe the Pump s display If display abnormalities are observed discontinue use of the Pump and refer servicing to qualified service personnel at your facility or return the Pump to Baxter for service NOTE The following shows some of the alarms that use the drug audio alarm se...

Page 109: ... the alarm tone for 2 minutes If the alarm has not been cleared after 2 minutes the alarm tone will resume NOTE Pressing the ON OFF key will cause the Pump to shutdown Clearing an Alarm To clear an alarm follow all of the prompts and instructions in the alarm message The alarm clears after the alarm condition has been corrected and all of the prompts followed Upstream Occlusion Downstream Occlusio...

Page 110: ... When programming the Pump the Clinician Alert Tone will occur if an action is not accepted or needs confirmation The Clinician Alert Tone is a triple beep tone that occurs every 10 seconds To silence the Clinician Alert Tone enter the necessary information until the action is accepted or enter a confirmation ...

Page 111: ...heck for an upstream occlusion from kinks in the tubing and closed clamps 6 Confirm the IV line is free of air and kinks 7 Unload the IV set to remove the air if necessary 8 Follow facility policy and procedures to remove the air manually 9 Reload the IV set 10 Close the Pump door If air is no longer detected by the Pump 11 Open the slide clamp and roller clamp 12 Press RUN to resume infusion If u...

Page 112: ...facility policy and procedures to remove the air manually 6 Reload the IV set 7 Close the Pump door 8 Confirm the IV line has been assessed 9 Open the slide clamp and roller clamp 10 Press RUN to resume the infusion OR To continue the infusion 1 Press confirm and continue the infusion with air detected 2 Press RUN to continue the infusion If using multiple Pumps Confirm correct IV line when checki...

Page 113: ...r to connecting to patient prime IV set following the standard gravity priming instructions included with the administration set remove all air close roller clamp and slide clamp load IV set into the Pump close the door open slide clamp and roller clamp AUDIO The audio alarm may be silenced for 2 minutes by pressing any key or the silence soft key BAG NEAR EMPTY 30 minutes remain Displays when the...

Page 114: ...ice CLOSE CLAMP RELOAD SET Displays when an IV set is loaded into the Pump before the Pump has completely powered on 1 Unload the IV set 2 Press ON OFF to power off the Pump 3 Press ON OFF to power on the Pump 4 After the Pump has completely powered on reload the IV set See Loading an IV Set on page 37 DOOR NOT FULLY LATCHED Displays when the Pump s door is closed but not fully in the locked posit...

Page 115: ... key to reset to the default setting or Select the no soft key to keep the current setting INACTIVITY ALARM Displays when the Pump has been inactive for 2 minutes and no action has been taken 1 Follow the on screen prompts 2 Resume or restart the Pump by pressing RUN IMPROPER SHUTDOWN Displays when data is lost from the previously programmed infusion 1 Press OK to clear the message 2 Re program th...

Page 116: ... selected during the Secondary Check Flow tutorial and yes is selected in response to Clamp Applied during tutorial See Secondary Infusion on page 58 At the end of a secondary infusion 1 Press the review Primary soft key 2 Remove applied clamp from primary line SECONDARY INFUSION COMPLETE Displays when the programmed secondary VTBI has counted down to zero and secondary callback is applied by eith...

Page 117: ... alarm occur with no direction on the screen 1 Disconnect the battery from the Pump and unplug the AC Power Adaptor from the AC outlet 2 Wait approximately 5 or more seconds reconnect the battery and plug the AC Power Adaptor into an AC power outlet 3 Press ON 4 If neither procedure clears the fault return the Pump for service CAUTION Unrecoverable System Error If unable to clear a fault condition...

Page 118: ...he programmed rate NOTE If unable to locate an occlusion see Troubleshooting Alarm Causes on page 114 WARNING Time to Upstream Occlusion at Lower Flow Rates When infusing at flow rates below 5 mL hr the Pump may take an extended period of time to detect an upstream occlusion and sound an alarm Ensure the following All clamps are open There are no kinks or collapses in the tubing outside of the Pum...

Page 119: ...he infusion transitions from Secondary to Primary 4 Any alarm condition that stops the Pump and when the Pump is powered OFF and then back ON WARNING Upstream Occlusion Alarm Suspension Do not use the Upstream Occlusion Alarm Suspension when delivering critical drugs where the risk of flow stoppage due to an undetected upstream occlusions outweighs that of flow interruption due to alarms where no ...

Page 120: ...iners by properly setting VTBI values Plug in the Pump s AC Power Adaptor to maintain battery charge Use the medium or high DS Pressure Limit Downstream Occlusion Pressure Limit setting at flow rate settings above 500 mL hr to avoid downstream occlusion alarms that are created by IV set pulsation Managing Bolus before Occlusion Downstream Release When a downstream occlusion alarm occurs pressure a...

Page 121: ...arm Instructions on page 157 If the Pump is not plugged in the battery will continue to slowly discharge even if the Pump is powered off Low Battery When the battery is low the Pump sounds a triple beep audio alarm every 5 seconds Press OK to temporarily suspend this alarm While suspended the Low Battery status will be indicated in the alert bar and a tone will be generated once every 5 minutes to...

Page 122: ...o dims to reduce battery usage See Figure 133 NOTE When the Very Low Battery warning initiates a minimum of 15 minutes of runtime remains Battery Depleted If the battery level drops below the Very Low Battery level the message changes to Battery Depleted See Figure 134 The Pump will stop running If the Pump is not plugged in within 3 minutes the Pump will shut itself off Figure 133 Very Low Batter...

Page 123: ... not immerse any part of the Pump or battery Do not use phenol based cleaners disinfectants Phenols degrade plastics and membrane switches Do not use abrasive cleaners Do not use rigid cleaning instruments Always use a lint free foam tipped swab to clean the tube channel Always dispose of all cleaning materials per federal state and local regulations for biohazard waste disposal Compatible Cleaner...

Page 124: ...ing of the battery terminals as well as to prevent any power from being applied to Pump circuitry while liquid cleaning solution is present which may cause corrosion 3 If a pole clamp is attached to the Pump remove the pole clamp by loosening the thumb screw on the Pump side adaptor back of the Pump and slide the Pump off of the pole clamp 4 Place the Pump in an upright position keyhole assembly u...

Page 125: ...pt to clean inside latch holes adjacent to the Direction of Flow label NOTE When cleaning the tubing channel do not allow cleaning fluids to seep into or between the Pump components 14 Wipe down the surface of door and tubing channel areas 15 Visually inspect the tubing channel and remove any foreign material An obstruction in the tubing channel could cause free flow 16 Clean the battery module fo...

Page 126: ...p 3 Apply cleaning agent to a dampened cloth per the manufacturer s instructions using appropriate dilution ratio Do not spray solutions directly on the AC Power Adaptor 4 Wrap the cloth on the AC Power Adaptor cord and clean the full length of the cord 5 Wipe the power cord housing and the connector and carefully clean the AC Power Adaptor prongs 6 Dry the AC Power Adaptor thoroughly 7 Inspect th...

Page 127: ...de the Pump off of the pole clamp 3 If the pole clamp is still attached to an IV pole turn the mounting knob counter clockwise to remove 4 Apply cleaning agent to a dampened cloth per the manufacturer s instructions using appropriate dilution ratio 5 Wipe the entire pole clamp including the screw mechanism 6 Use a soft brush to clear debris from the screw mechanism 7 Dry the pole clamp thoroughly ...

Page 128: ...ARNING Pump Storage Remove the Battery Module from the Pump when storing the Pump for extended periods WARNING Ensure Secure Mounting of Pump During Use and Transport During use and transport securely mount Pumps to IV pole by centering the pole in the clamp and turning the mounting knob clockwise To maintain IV pole stability never exceed 210 cm 83 in from floor to IV pole top and limit bag volum...

Page 129: ...ble set list See Compatible Baxter IV Sets WARNINGS on page 127 All sets must include a Blue Slide Clamp on the section of the set to be placed into the Pump See Figure 136 Figure 136 Blue Slide Clamp No Brief Description Primary Set Macro 10 drops mL 1C8109s Solution Set 101 2 6 m Male Luer Lock Adapter 1C8160s Solution Set 69 1 8 m Male Luer Lock Adapter 1C8296s Solution Set 125 3 2 m Male Luer ...

Page 130: ...FLO Solution Set 112 2 8 m 2 Luer Activated Valves Male Luer Lock Adaptor2 2C8537s CLEARLINK System CONTINU FLO Solution Set 109 2 8 m 3 Luer Activated Valves Male Luer Lock Adapter with Retractable Collar2 2C8541s CLEARLINK System CONTINU FLO Solution Set with DUO VENT Spike 105 2 7 m 3 Luer Activated Valves male Luer Lock Adapter with Retractable Collar2 8 3C0062s INTERLINK System CONTINU FLO So...

Page 131: ...e Extended Life Filter 2 Luer Activated Valves Male Luer Lock Adapter with Retractable Collar2 4 Primary Filter Set Minidrip 60 drops mL 2C6572 Continu Flo Solution Set 105 2 7 m 0 22 Micron High Pressure Extended Life Filter 2 Injection Sites Male Luer Lock Adapter1 2 4 Buretrol Minidrip 60 drops mL 2C7562s INTERLINK System BURETROL Solution Set 115 2 9 m 150 mL Valveless Burette 4 Injection Site...

Page 132: ... m Luer Activated Valve Male Luer Lock Adapter with Retractable Collar11 2H8519 CLEARLINK System Non DEHP CONTINU FLO Solution Set 96 2 4 m 2 Luer Activated Valves Male Luer Lock Adapter with Retractable Collar11 2H8537 CLEARLINK System Non DEHP CONTINU FLO Solution Set 109 2 8 m 3 Luer Activated Valves Male Luer Lock Adapter with Retractable Collar11 2H8454 CLEARLINK System Non DEHP CONTINU FLO S...

Page 133: ...icable with non DEHP tubing because 250 mL hr is the maximum flow rate per warning statement Buretrol Minidrip 60 drops mL 2H8862 CLEARLINK System Non DEHP BURETROL Solution Set 115 2 9 m 150 mL Valveless Burette 4 Luer Activated Valves Male Luer Lock Adaptor with Retractable Collar1 5 8 11 2H8864 CLEARLINK System Non DEHP BURETROL Solution Set 105 2 7 m 150 mL Burette Drip Chamber Filter Valve 3 ...

Page 134: ...lamps Only the slide clamp on the pumping section or on the section with the main roller clamp should be used for pumping operation and clamp detection Other slide clamps on the set must be used with the set and need to be observed and controlled by the user To prevent free flow the slide clamp on the tubing that is loaded into the Pump should be used to open the Pump door 9 Blood sets with both c...

Page 135: ...uate drugs prescribed therapies and patient populations NOTE See Appendix D Downstream Occlusion on page 150 for downstream occlusion times and bolus release information WARNING Use the Specified Manufacturer s IV Set A label located on the top of the Pump indicates the specific type of IV tubing that the Pump has been calibrated for The use of other manufacturers brands or type tubing could produ...

Page 136: ...right tubes and aluminum plate C clamp jaw opening expands to 3 8 cm 1 5 in C clamp knob comes off if semi permanent attachment of carrier is desired Figure 137 Baxter P N 55092NS Holds three Pumps Stainless upright tubes and aluminum plate UL CSA four outlet power strip for multi pole plug in 1 cord from IV pole to wall outlet C clamp jaw opening expands to 3 8 cm 1 5 in C clamp knob comes off if...

Page 137: ...imit bag volume at this extended height to 1 liter 1000 cc CAUTION Entanglement Always route IV set tubing and AC Power Adaptor cabling to prevent patient hazard or entanglement Use the supplied strap to secure excess power cord length Identify the individual IV set lines when multiple Pumps and routes of administration are practiced Holds five Pumps Adjustable height stainless steel pole 7 hook t...

Page 138: ... the clamp on the IV pole by rotating the triangular knob clockwise The cylindrical protrusion on the triangular knob helps to rotate the knob faster The Pump mounted on the adaptor can be rotated clockwise or counterclockwise in 90 increments by pressing the lever located on the arm The Pump can be offset by the length of the arm by rotating the arm in clockwise or counterclockwise in 90 incremen...

Page 139: ...me and Concentration Programming mode Delivery Bag Dose mode and Upper and Lower Hard and Soft Limits and Starting rates where applicable The Care Area enables Same name same concentration drugs to have different dose rate limits Configurations for Patient Weight and BSA Limits Downstream Occlusion Pressure settings Priming Volume adjustments and Auto Keypad Lock Drug Library Transfer The Drug Lib...

Page 140: ...high medium and low For more detail see Appendix G Default Settings on page 160 Alarms and Alerts Air In Line dual beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass Detects air bubbles 2 5 cm 1 in approximately 140 µL in Baxter sets Detects 1 mL of accumulated air over 15 min excluding 10 µL bubbles at room temperature Detects 1 5 mL of accumulated air over 15 mi...

Page 141: ...System is classified according to Medical Electrical Equipment standards as Class II Equipment Type BF Applied Part Continuous Operation Disinfect according to Cleaning and Storage on page 117 Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide IPX0 Enclosure does not protect equipment against ingress of water with harmful effects Tested ...

Page 142: ...rotocol Flow Rate 0 5 to 999 mL hr with 0 1 mL hr increments from 0 5 to 99 9 mL hr and 1 0 mL hr increments from 100 to 999 mL hr Infusion Delivery Modes Continuous Primary and Secondary Multi Step Cyclic TPN and Amount Time Primary and Secondary KVO At the completion of a primary infusion the Pump will infuse at the KVO rate configured per drug in the Drug Library or the current infusion rate wh...

Page 143: ...kPa 30 psi Downstream Occlusion Pressure Adjustable Low 41 kPa 27 kPa 6 4 psi Medium 89 kPa 41 kPa 13 6 psi High 131 kPa 62 kPa 19 9 psi Operational Conditions With Standard Battery Operating temperature 15 6 to 32 2 C 60 to 90 F 20 to 90 relative humidity non condensing With Wireless Battery Module Operating temperature 15 6 to 26 7 C 60 to 80 F 20 to 90 relative humidity non condensing WARNING E...

Page 144: ...ar peristaltic Single Fault Condition A maximum bolus of 0 56 mL may be generated as a result of a Single Fault Condition a failure of the SIGMA Spectrum Infusion Pump which stops the Pump motor and results in an alarm Timekeeping Real Time Clock battery backed 10 year life NOTE Clock is set to GMT Total Volume 0 1 to 9999 mL with 0 1 mL increments from 0 1 to 99 9 mL and 1 0 mL increments from 10...

Page 145: ...1 kg 26 5 oz 1 0 oz With IV pole clamp 0 978 kg 34 5 oz 1 0 oz Wireless Network Interface Wireless Battery Module 802 11b g Baxter P N 35162 Frequency 2 4 Ghz Standard IEEE 802 11b IEEE 802 11g Typical Transmit Power 18 dBm 1Mbps 16 dBm 11 Mbps 14 dBm 6 Mbps 12 dBm 54 Mbps Wireless Security WEP Wired Equivalent Privacy Encryption 64 128 bit RC4 WPA WPA2 802 11i Encryption TKIP CCMP AES WPA PSK 802...

Page 146: ...a 50 cm 20 in fluid head height resulting in a flow rate accuracy of 5 to 9 Effect of Back Pressure Positive back pressure can influence the flow rate accuracy of the infusion Back pressure equivalent to 300 mmHg may reduce the flow rate causing a deviation in accuracy by 9 Negative back pressure of 100 mmHg may increase flow rate causing a deviation in accuracy of 7 in Baxter IV Sets WARNING Baxt...

Page 147: ...he slide clamp on the tubing that is loaded into the Pump should be used to open the Pump door 9 Blood sets with both clamps closed above the blood filter will cause upstream occlusions that may not be detected by the Pump 10 Sets containing a manifold may require longer times to detect downstream occlusions 11 When using the compatible non DEHP IV administration sets in the Pump the following per...

Page 148: ...ainer flat Doing so may influence flow rate accuracy and cause upstream occlusion and air in line alarms Exceeding 500 mL hr flow rate settings when using sets with backcheck valves Doing so may influence flow rate accuracy or cause air in line or upstream occlusion alarms Flow rates above 300 mL hr may cause fluid to be siphoned from the primary container during a secondary infusion See Secondary...

Page 149: ...Infusion System mean flow over a specific measurement interval is provided NOTE It is important for the clinician to understand the pharmacological influence of specific drugs based on concentrations and patient response when used in conjunction with the SIGMA Spectrum Infusion System Pumping mechanisms produce fluctuation in fluid flow by design based on the specific mechanism type peristaltic pi...

Page 150: ...144 Appendix B Flow Rate Accuracy Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual Baxter Administration Set Accuracy Graphs ...

Page 151: ...Appendix B Flow Rate Accuracy 145 SIGMA Spectrum Infusion System Pump Operating Software Version 8 00 Operator s Manual For Use With MDL Version 8 0 ...

Page 152: ...146 Appendix B Flow Rate Accuracy Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual ...

Page 153: ...Appendix B Flow Rate Accuracy 147 SIGMA Spectrum Infusion System Pump Operating Software Version 8 00 Operator s Manual For Use With MDL Version 8 0 ...

Page 154: ...148 Appendix B Flow Rate Accuracy Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual ...

Page 155: ...r the bolus delivery The limit constraints are contained within the software of the SIGMA Spectrum Infusion System and are necessary to control the maximum or minimum flow rate of the bolus infusion The accuracy of the bolus volume is dependent on the resultant flow rate that is obtained from the calculation of volume to be delivered in the time requested For example if the bolus volume is 300 mL ...

Page 156: ...um downstream occlusion alarm threshold is 0 25 mL The maximum bolus volume generated as a result of operation at 25 mL hr and reaching the maximum downstream occlusion alarm threshold is 0 8 mL WARNING Specifications for Downstream Occlusion detection times and bolus volume after release of occlusion are based on specific test conditions The analytical related conditions are A distance of 1 2 m 4...

Page 157: ...ectrosurgical equipment that may generate strong radio frequency interference RFI See Immunity Separation Distances on page 156 for the recommended minimum distance Guidance and manufacturer s declaration electromagnetic emissions for all equipment and systems The SIGMA Spectrum Infusion System is intended for use in the electromagnetic environment specified below The customer or user of the Pump ...

Page 158: ... 2 kV for power supply lines Not applicable Supply power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode Not applicable Supply power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61...

Page 159: ...ch it will be used NOTE The SIGMA Spectrum Infusion System has been tested to operate normally when used stacked or adjacent to other SIGMA Spectrum Infusion Systems CAUTION ECG Artifacts Related to the Use of the SIGMA Spectrum Infusion System Peristaltic infusion pumps may produce what is known as piezoelectric artifact on ECG monitors and similar types of monitoring instruments The SIGMA Spectr...

Page 160: ...SM bands b 10 V m 80 MHz to 2 5 GHz 3 Vrms 10 Vrms 10 V m Portable and mobile RF communications equipment should 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 Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2 5 GHz Where P is the maximum output power rating...

Page 161: ...ons equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 3K is used in calculating the recommended separation distance for transmitters in these frequency ranges c Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio amateur radio AM and FM radio broadcast an...

Page 162: ...on distance according to frequency of transmitter m 150 kHz to 80 MHz outside ISM bands 150 kHz to 80 MHz in ISM bands 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 12 23 0 1 0 38 0 38 0 38 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at maximum output power not listed above the recommended separation distance d in meters m can be determined using the equa...

Page 163: ...se With MDL Version 8 0 APPENDIX F LOW VERY LOW BATTERY ALARM INSTRUCTIONS The Low Battery and Very Low Battery alarms provide on screen step by step instructions for confirming that the external power supply is connected to the wall outlet the power light is illuminated and the power cord is properly connected to the SIGMA Spectrum Infusion Pump ...

Page 164: ...ery Alarm Instructions Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual Low Battery Alarm Instructions The Pump displays the following screen by screen instructions when the Low Battery alarm is activated ...

Page 165: ...SIGMA Spectrum Infusion System Pump Operating Software Version 8 00 Operator s Manual For Use With MDL Version 8 0 Very Low Battery Alarm Instructions The Pump displays the following screen by screen instructions when the Very Low Battery alarm is activated ...

Page 166: ...um High Yes Drug Level Configuration Audio Tone Long Long Short No Standby Delay Infinite Infinite Specified Time frame No Bag Near Empty Alarm Off On Off Yes Drug Level Configuration DS Pressure Limit Downstream Occlusion Pressure Limit Medium Low Medium High Yes Care Area Level Configuration DS Pressure Limit can be set in the Drug Library by Care Area The user still retains the ability to chang...

Page 167: ...gle Step Rate Change of 101 CAUTION BASIC Programming Use BASIC programming should only be used when the desired drug or concentration is not available in the facility s Drug Library Table 3 BASIC Fixed Settings BASIC Configuration Settings Fixed Settings Allow Bolus Yes Allow Loading Dose No Bolus Amount Units mL Bolus Time Units Minutes and Seconds 00 00 Completion Alarm Not Available Delayed Ru...

Page 168: ...e See the description of Upstream Occlusion Alarm Suspension in Alarm Messages on page 105 Table 6 Dose Modes Available in BASIC Mode BASIC Configuration Settings Default Settings Any Infusion while in BASIC Mode mL hr mL kg min mL kg hr g hr mg hr mg kg hr mg min mg kg min mg kg day mcg hr mcg kg hr mcg min mcg kg min mcg kg day ng min ng kg min Units hr Units kg hr Units min Units kg min mUnits ...

Page 169: ...l Corporation BASIC A method of programming a continuous infusion where Drug Library limits are not present BCC Battery Charger Controller BDL Binary Drug Library A BDL file is created and saved using the MDL software and the file is transferred to the SIGMA Spectrum Infusion Pump BF Body Floating A medical safety standard rating Type BF for devices that have conductive contact with the patient or...

Page 170: ...rent DEHP Bis 2 ethylhexyl phthalate A plasticizer used to make IV tubing flexible DERS Dose Error Reduction System DHCP Dynamic Host Configuration Protocol Automates the assignment of IP addresses Distal Downstream of the pump Farthest from the center or midline of the body or trunk or from the point of attachment DL Drug Library DNS Domain Name System Dongle A device that attaches to a computer ...

Page 171: ...r than 1 standard atmosphere of pressure Hz Hertz ICU Intensive Care Unit IEC International Electrotechnical Commission IEEE Institute of Electrical Electronic Engineers in Inch IO PCB Input Output Printed Circuit Board IP Address Internet Protocol Address A 4 byte value with 4 numbers ranging from 0 255 separated by decimals that is unique for each smart IV pump and other devices on a network For...

Page 172: ...s a PC based software tool used to enter and configure facility specific intravenous drugs for therapy delivery by the SIGMA Spectrum Infusion Pump MDLA Master Drug Library Administrator Person responsible for creating editing and maintaining the Drug Library Med Surg Medical Surgical mEq Milliequivalent 1 1000 10 3 of an equivalent mg Milligram 1 1000 10 3 of a gram MHz Megahertz min Minute mL Mi...

Page 173: ... PDF Portable Document Format A file format that has captured all the elements of a printed document as an electronic image that you can view navigate print or forward PEAP Protected Extensible Authentication Protocol Pediatric Medical care of infants children and adolescents PEM Privacy Enhanced Mail PIC I O processor I O Board 60091 CFG2 Microchip PIC 16F family micro controller with on chip A D...

Page 174: ...ring the user to reject or accept the value entered SPI Serial Peripheral Interface SSID Service Set Identifier The name of an individual wireless local area network Can be public in which the SSID is broadcast for all to see on the WLAN or private in which the SSID is not broadcast A private SSID requires that each connecting device must know the SSID ahead of time TCP Transmission Control Protoc...

Page 175: ...se With MDL Version 8 0 VLAN Virtual local area network Vrms Volts root mean square VTBI Volume To Be Infused WBM WIreless Battery Module WEP Wired Equivalent Privacy Wireless Frequency Security Method WLAN Wireless Local Area Network WPA PSK Wireless Protected Access Pre Shared Key µ Micro µL Microliter ...

Page 176: ...170 Glossary Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual ...

Page 177: ...Low Battery 157 Alarm Instructions 159 Volume Specifications 134 Alarms and Alerts Specifications 134 Anti Free Flow System Specifications 134 Audio Tone 33 Volume 33 B BASIC Configurations List of Available Dose Modes 162 List of Configurable Settings 161 List of Settings Configurable in the Drug Library 162 List of Settings that Cannot be Changed 161 BASIC Mode Programming 94 Battery 802 11b g W...

Page 178: ...with a Wireless Battery Module 49 Information 35 Transfer Specifications 133 E Electromagnetic Compatibility Information 151 Error Log Drug 35 System 35 External Interfaces Specifications 136 F Flow Rate Specifications 136 Flush Primary Line 88 Secondary Line 91 H Hard keys 23 Hard Limits 55 Below 55 Exceeding 55 History Log Event Log Viewing 35 I Icons Battery 21 Callback 21 DL Drug Library 21 49...

Page 179: ...g 122 Transporting 122 Unpacking 29 Pumping Mechanism Specifications 138 R Rate Change 58 Continuous Infusion 76 Regulatory Information 1 Run Screen Options 34 S Secondary Infusion Bag height 46 Clearing 63 Error Reduction 47 Line Flush 91 Programming 58 Setup 46 VTBI 47 Single Fault Condition Specifications 138 Single Step BASIC Fixed Settings 161 Dose Change 47 56 Rate Change 47 56 Soft keys 22 ...

Page 180: ...n System Revision B Operator s Manual Changing Without Stopping the Pump 78 W Weight Confirmation 80 Weight of Pump Specifications 139 Weight BSA Confirmation screen 55 Wireless Network Interface Specifications 139 Wireless Security Specifications 139 ...

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