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Accuracy Tests

9-10

COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR’S MANUAL

071960491

Average of 8 pumps

2nd Hour Q (Flow Rate) = 1.01, A (Accuracy) = 0.71%

35%

25%

15%

-35%

-25%

-15%

-5%

min

Figure 9-4 Trumpet Graph, 2nd Hour of Delivery, 1 mL/hr

72nd Hour

1.4

1.2

1.0

0.8

0.6

0.4

0.2

0.0

Time (minutes)

Qi (mL/hr)

4260

4270

4280

4290

4300

4310

4320

Average of 8 pumps

Figure 9-5 Flow Accuracy, 72nd Hour, 1 mL/hr

Average of 8 pumps

72nd Hour Q (Flow Rate) = 1.04, A (Accuracy) = 3.86%

35%

25%

15%

-35%

-25%

-15%

-5%

min

Figure 9-6 Trumpet Graph, 72nd Hour of Delivery, 1 mL/hr

Summary of Contents for Colleague 3 CXE

Page 1: ...N PRODUCT CODES 2M91617 and 2M91637 Operator s Manual E CXE X C E C XE X C C O LLEAG U E G U A R D IA N Prior to using this pump read this manual carefully to fully understand the pump s functionality and to ensure safe and proper operation 071960491 ...

Page 2: ...f their respective owners Patent Information This device is protected under one of more of the following U S and foreign patents United States 5151019 5764034 5779207 5782805 5842841 6013057 6123524 D390654 RE37074E 2004 0193325A1 Australia 130693 706187 710286 712859 713132 721076 740655 Austria E248618 E255925 Belgium EP0833674 EP0836492 EP0837708 EP0891784 Canada 2223838 2223841 2223897 80218 D...

Page 3: ...North America 1 1 Outside North America 1 1 Overview 1 1 Safety Summary 1 3 Standards 1 3 Labeling Symbol Definitions 1 4 Warnings and Cautions 1 6 Definitions 1 6 Warnings 1 7 Cautions 1 9 Notes 1 10 Indications for Use 1 10 Chapter 2 Description 2 1 Overview 2 1 Description of Controls and Indicators 2 2 Front Panel Features 2 2 Pump Module Features 2 6 Rear Panel Features 2 8 Color Reference Gu...

Page 4: ...ume Time Infusions 2 20 COLLEAGUE GUARDIAN Feature 2 20 Dose Modes 2 23 How Concentration is Determined 2 23 How Doses and Rates are Calculated 2 23 Changing a Parameter After All Parameters Have Been Entered 2 24 Changing Units of Measure 2 24 Primary Delay Start Mode 2 25 Chapter 3 Preparation for Use 3 1 Environmental Conditions 3 1 Setup Instructions 3 1 Initial Installation 3 1 Mounting the P...

Page 5: ...Battery Charge 4 6 Low Battery Condition 4 7 Depleted Battery Condition 4 7 Operating on Battery Power 4 8 Battery Charge Icon Descriptions 4 8 Battery Charge Alerts and Alarms 4 10 Battery Charge Progress Indicator Alert 4 12 Damaged Battery Alert and Alarm 4 13 Preparing for an Infusion 4 13 Preparing the Primary Infusion Container and Set 4 13 Replacing the Primary Infusion Container Using the ...

Page 6: ... Infusions 4 45 Preparing a Secondary Infusion Set 4 46 Programming a Secondary Rate Volume Infusion 4 46 Programming a Secondary Volume Time Infusion 4 49 Enabling the Secondary Callback Alert Option 4 50 Standby Mode 4 50 Standby Activation Single Channel Pumps 4 51 Standby Activation Triple Channel Pumps 4 52 Standby Deactivation 4 54 Programming a Delay Start Infusion 4 54 Viewing Delay Start ...

Page 7: ...on 4 68 Infusion Complete Switch to KVO 4 69 Unloading the Administration Set 4 70 Automatic Unloading 4 70 Using the Manual Tube Release 4 71 Resetting the Manual Tube Release 4 72 Powering Off the Pump 4 73 Options Menu 4 74 Overview 4 74 Managing Occlusion Settings 4 75 Auto Restart 4 76 Viewing PERSONALITY Settings 4 77 Using Flow Check Display 4 77 Using the Configuration Service Function 4 7...

Page 8: ...tive Maintenance 7 2 Battery Care 7 3 Battery Service Life 7 4 Optimizing Battery Service Life 7 5 Charging the Batteries 7 5 Disposing of Used Batteries 7 6 Storage 7 6 Chapter 8 Troubleshooting 8 1 Alert Alarm and Failure Messages 8 1 Troubleshooting Failures 8 2 Overview 8 2 Device Failure 8 2 Channel Failures Single Channel Pumps 8 3 Channel Failures Triple Channel Pump 8 5 Troubleshooting Ala...

Page 9: ...Description 9 7 How Trumpet Curve Graphs are Interpreted 9 8 How Trumpet Curve Graphs are Created 9 8 How Trumpet Curves can be Used 9 9 Accuracy Tests 9 9 Tested at 1 mL hr 9 9 Tested at 25 mL hr 9 11 Electromagnetic Compatibility Statement 9 14 Chapter 10 Warranty and Service Information 10 1 Warranty 10 1 Service Information 10 2 Authorized Service Centers 10 2 Chapter 11 Quick Reference Guide ...

Page 10: ...RDIAN Infusion Rate Volume 11 8 Programming a COLLEAGUE GUARDIAN Dose Mode Infusion 11 10 Programming a Dose Mode Infusion 11 13 Programming a Secondary Rate Volume Infusion 11 14 Programming a Secondary Volume Time Infusion 11 15 Standby Mode 11 15 Unloading the Administration Set 11 17 Automatic Unloading 11 17 Using the Manual Tube Release MTR 11 17 Resetting the Manual Tube Release 11 18 Troub...

Page 11: ...ne Styrene ABS Acetal 25 Glass Fiber GF Reinforced Acetal Polytetrafluoroethylene PTFE Acrylic Aluminum A380 0 13 GF Nylon 30 GF Nylon 33 GF Nylon 30 GF Reinforced Polybutylene Terephthalate PBT 30 GF PBT PTFE 40 GF Polyphenylene Sulfide PPS Nylon PBT Polycarbonate PC PC ABS PC Polyethylene Terephthalate PET Polyetheretherketone PEEK PET Glycol PETG Polyester PBT Polyimide Polypropylene Poron Uret...

Page 12: ...ommunities concerning medical devices The electromagnetic compatibility EMC requirements are part of the essential requirements of the Medical Device Directive Device COLLEAGUE CXE Volumetric Infusion Pump COLLEAGUE 3 CXE Volumetric Infusion Pump Catalogue Number 2M91617 2M91637 Manufacturer Baxter Healthcare SA 8010 Zurich Switzerland Baxter Healthcare Corporation Deerfield IL 60015 USA Made in S...

Page 13: ...03 Outside North America Visit www baxter com baxter_worldwide html for contact information or call your Baxter customer service representative to locate the nearest service center Overview Note All information contained in this manual is applicable to the COLLEAGUE CXE single channel pump and COLLEAGUE 3 CXE triple channel pump unless otherwise noted The COLLEAGUE CXE and COLLEAGUE 3 CXE pump fea...

Page 14: ...hed by the facility an out of limits warning occurs The COLLEAGUE GUARDIAN feature is a configurable option that is available for both rate volume and dose mode programming Programmable air sensor with detection sensitivity ranging from 25 to 150 microliters Programmable downstream occlusion detection settings ranging from 2 psig to 15 psig 103 mmHg to 775 mmHg Automatic restart if downstream occl...

Page 15: ...601 1 this pump is classified as Class 1 Type CF Drip proof IPX1 Not suitable for use with flammable anesthetic mixtures with air oxygen or nitrous oxide Continuous operation This manual has been developed with consideration to the requirements in the International Standard IEC 60601 2 24 1998 Medical Electrical Equipment Part 2 24 Particular Requirements for Safety of Infusion Pumps and Controlle...

Page 16: ...ispose of properly For products where this mark is present the device is classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA C22 2 No 601 1 Brazil certification to INMETRO National Institute of Metrology Standardization and Industrial Quality USP IEE University of São Paulo Institute of Electrotechnic...

Page 17: ...ributed after August 13 2005 Battery Nonspillable lead acid sealed battery For more information on return recovery or recycling of this product please contact your local Baxter representative Fragile handle with care Keep dry Operating temperature limits Storage temperature limits Transport temperature limits Transport humidity limits Transport atmospheric pressure limits Carton stacking limit sin...

Page 18: ... not avoided could result in severe personal injury or death Caution messages indicate a problem or unsafe practice which if not avoided could result in minor or moderate personal injury product or property damage Note messages provide supplemental information to the accompanying text Labeling abbreviations COMM PORT Communications Port VOL Volume CONT Contrast SN 15040362DL Sequential Number Sing...

Page 19: ... infusion of drugs not indicated for epidural use do not use administration sets incorporating injection sites during epidural delivery Clearly distinguish pumps used for epidural drug delivery from pumps used for other routes of administration WARNING This device should be repaired only by Baxter authorized service personnel or Baxter trained hospital biomedical engineering personnel using only B...

Page 20: ...istration set labels When using the secondary infusion feature ensure the medication solution in the secondary source container is compatible with the medication solution in the primary source container the secondary administration set is connected to the appropriate injection site on the CONTINU FLO administration set the interruption of the primary infusion is clinically appropriate for the dura...

Page 21: ...ow fluid to enter the tubing channel or load wet tubing into the pump Contact your Baxter Service Center for assistance immediately if fluid enters the tubing channel The tubing channel should be cleaned as soon as possible by Baxter trained qualified personnel to minimize potential difficulties caused by fluid pooling and drying on the mechanism Fluid in the tubing channel can also cause false Ai...

Page 22: ...sion Pumps are capable of delivering medications solutions parenteral nutrition lipids blood and blood components The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps are capable of infusing from semi rigid containers rigid containers flexible IV bags and vented syringes The COLLEAGUE CXE and COLLEAGUE 3 CXE pumps are designed to deliver infusion therapies via clinically acceptable routes of administration...

Page 23: ...luated for use in care areas other than those listed above General Floor of the Hospital Critical Intensive Care Neonatal Intensive Care Pediatric Care Labor Delivery Postpartum Operating Room Anesthesia Post Anesthesia Recovery Cardiac Catheterization Lab Emergency Room Ground Ambulance Hospice Facility Outpatient Subacute Facilities Nursing Facilities Long Term Care Rehabilitation Facilities Dia...

Page 24: ...1 Indications for Use 1 12 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 25: ...dicators and displays on the pump and provides a brief functional description of the pump s features and infusion modes The following information is provided in this chapter Description of Controls and Indicators on page 2 2 Display Reference Guide on page 2 9 Label Location on page 2 16 Pump Software Features on page 2 18 Infusion Modes on page 2 19 ...

Page 26: ...and Indicators Front Panel Features Figure 2 1 is the front view of the single channel pump E C XE X C C O LLEAG U E G U A R D IA N Figure 2 1 Front View Single Channel Pump MAIN BODY See Table 2 1 PUMP MODULE See Table 2 2 MAIN DISPLAY PUMP MODULE DISPLAY SLOT FOR KEYED SLIDE CLAMP STATUS LEDS TUBING CHANNEL FLUID FLOW DIRECTION LABEL ...

Page 27: ...channel pump Table 2 1 describes the controls and indicators on the main body of the pump E C XE X C C O LLEAG U E G U A R D IA N Figure 2 2 Front View Triple Channel Pump CHANNEL A CHANNEL C CHANNEL B MAIN DISPLAY MAIN BODY See Table 2 1 PUMP MODULES See Table 2 2 PUMP MODULE DISPLAY SLOT FOR KEYED SLIDE CLAMP STATUS LEDS TUBING CHANNEL TUBING CHANNEL TUBING GUIDE ...

Page 28: ...ation for all three channels This key silences alarms and alerts for two minutes This key turns the back lights for the main display and the pump module display s on and off During battery powered operation this key illuminates the back lights for 60 seconds following the last key press Action Keys This key selects the Rate field This key selects the Vol Volume to be infused field This key initiat...

Page 29: ...ed into AC power Illumination of this icon also indicates the battery is being charged This yellow icon is lit only when the pump is operating on battery power MONITOR For Baxter diagnostic purposes only COMPUTER CONTROL FOR FUTURE USE Triple channel pumps only The color coded tubing guide on the left side of triple channel pumps assists the clinician in identifying lines during a multi channel in...

Page 30: ...sage options Rate Time Remaining Volume Infused Label The message displayed depends upon the specific options selected by the care site Specific operations such as tube loading are also indicated on the pump module display The pump module display also provides brief alarm and alert messages Key Description Triple channel pumps only When pressed once this key selects or deselects a particular pump ...

Page 31: ...ys ensure that the tubing from the container enters the left side of the pump This patient symbol below the right side of the tubing channel indicates the downstream side of the pump When loading the administration set always ensure that the tubing from the pump to the patient exits right side of the pump These arrows indicate the direction of fluid flow while the pump is running LEDs Description ...

Page 32: ... PANEL LOCKOUT BUTTON COMMUNICATION PORT MOUNTING CLAMP RELEASE LATCH MAIN DISPLAY CONTRAST CONTROL POWER CORD NOTE THE CORD MAY DIFFER FROM THAT SHOWN AUDIO SPEAKER VOLUME CONTROL FUSE HOLDERS BACKUP BEEPER GRILL AUDIO SPEAKER GRILL Table 2 3 Rear Panel Features Item Description Communication port An RS232 interface enables optional communication functions For service use only Fuse holders The pu...

Page 33: ...l attention to a condition Infusion program information is yellow Yellow is used in the display status line to indicate an alert condition The ALERT LED on the pump head module is yellow Red Red is used to indicate a serious condition or stop Red is used in the display status line to indicate an alarm or failure condition The red stop sign icon indicates that an infusion is stopped The ALARM LED a...

Page 34: ...er indicates that the current infusion is a secondary Yellow mortar and pestle indicates that the current infusion is using a label for which COLLEAGUE GUARDIAN feature limits have been configured Stopwatch indicates a Delay Start infusion has been programmed Infusion parameters The programmed values for the current or most recent infusion including rate time remaining and volume remaining Dose mo...

Page 35: ...ers Soft keys COLLEAGUE GUARDIAN feature icon mortar and pestle Up and down arrow keys Dose mode identifier Triple Channel Pump Single Channel Pump Infusion parameters Label Prompt line Battery Charge Icon blinking Operating State Icon Running Status line no message present Soft key identifiers Soft keys COLLEAGUE GUARDIAN feature icon mortar and pestle Up and down arrow keys Dose mode identifier ...

Page 36: ...ires that different information be programmed Programming screen examples are shown in Figure 2 5 Figure 2 5 Programming Screen Information Examples Pop up window Rate Field Volume Field Status Line Soft key identifiers Prompt line Soft keys Triple Channel Pump Single Channel Pump Rate Field Volume Field Status Line Soft key identifiers Prompt line Soft keys Pop up window Secondary Infusion Icon B...

Page 37: ... that appear on the Main Display Figure 2 6 Menu Example Table 2 6 Main Display Icons Icon Description This icon indicates that air has been detected by the air sensor This icon indicates that air has exited from the air sensor area and fluid is now detected The battery charge icon is displayed at all times in the upper left part of the screen The number of filled areas in the battery charge icon ...

Page 38: ... plugged in the battery charge icon alternates with the charging icon shown at left When the pump is unplugged and operating on battery power the battery charge icon alternates with the Plug In icon shown at left and the approximate battery operating time is displayed below the icon The pump should be plugged in whenever possible to maintain battery charge A drop icon is displayed for each channel...

Page 39: ... of each channel running an infusion utilizing a COLLEAGUE GUARDIAN label Yellow Triangle next to a label in the COLLEAGUE GUARDIAN label list indicates that the label allows non standard concentrations to be programmed by the clinician White triangle next to a field on the programming screen for a COLLEAGUE GUARDIAN infusion indicates that the clinician has changed the default value Triangle next...

Page 40: ...your local Baxter Service Center for replacement information Figure 2 7 Location of Pump Labeling Single Channel Pump ATTENTION MANUAL TUBE RELEASE MOUNTING CLAMP SIGNATURE RATINGS PATENTS ON UNDERSIDE MAINTAIN BATTERY CHARGE OPTIONAL SERIAL NUMBER BAR CODE COLLEAGUE GUARDIAN FEATURE CE MARK WORDMARK COLLEAGUE CXE FLUID FLOW VOLUME CONTROL FUSES EXTERNAL English pumps only ACCESSORIES POWER CORD W...

Page 41: ...ANNEL SELECT C LABEL WORDMARK FLUID FLOW VOLUME CONTROL FUSES EXTERNAL ACCESSORIES PATENTS ON UNDERSIDE CONTRAST CONTROL MANUAL TUBE RELEASE ATTENTION SERIAL NUMBER BAR CODE CE MARK SIGNATURE RATINGS English pumps only MAINTAIN BATTERY CHARGE OPTIONAL COLLEAGUE GUARDIAN FEATURE POWER CORD WARNING UL cUL WEEE SIGNATURE RATINGS English for non English pumps only SIGNATURE RATINGS local language for ...

Page 42: ...SONALITY feature set when the pump is powered on The PERSONALITY feature set can only be changed at power on For instructions on selecting a PERSONALITY feature set see Selecting a Pump PERSONALITY Feature Set 4 5 The Permanent Settings PERSONALITY feature set is the factory default and its parameters cannot be changed but it can be copied and modified to create custom PERSONALITY feature sets tai...

Page 43: ...a Label 4 23 Labels are chosen from a list of predefined or custom labels When the Label Library feature is enabled the user can select from the list of available labels For a list of predefined labels see Predefined Labels on page 6 7 When the label library is viewed the application labels are listed first followed by the medication solution labels For a list of application labels see Application...

Page 44: ...hout stopping the primary infusion For instructions on programming Volume Time infusions see Programming a Primary Volume Time Infusion 4 25 and Programming a Secondary Volume Time Infusion 4 49 COLLEAGUE GUARDIAN Feature The COLLEAGUE GUARDIAN feature is a configurable option that helps to reduce the potential for medication programming errors by allowing program limits to be predefined for label...

Page 45: ... or by pressing the Change Mode soft key and selecting Colleague Guardian from the Programming Modes menu Labels selected from the COLLEAGUE GUARDIAN list have predefined program limits If the clinician chooses to change the program so that the predefined limits are overridden a warning is displayed The warning pop up includes the programmed dose and the preprogrammed dose limits The clinician can...

Page 46: ...efault dose may be preconfigured if so the Dose field is prefilled on the programming screen when the label is selected For dose modes COLLEAGUE GUARDIAN parameters can be configured to allow changes to the standard concentration If changes to standard concentration are not allowed the Diluent Volume and Concentration fields cannot be edited by the clinician when programming an infusion If changes...

Page 47: ... infusion parameter Concentration is determined by dividing the drug amount into the diluent volume If the concentration is known it can be entered directly into the pump If concentration is the first parameter entered the Drug Amount and Diluent Volume fields are cleared How Doses and Rates are Calculated Concentration must be entered or calculated before the rate or dose can be calculated After ...

Page 48: ...Volume is changed the Concentration is recalculated If the Concentration is changed the Drug Amount and Diluent Volume will be cleared If a parameter that could indirectly affect the Dose or Rate such as patient weight is changed the Rate will change but the Dose remains constant Changing Units of Measure Units of measure can be changed for the Drug Amount and Concentration values Whenever a unit ...

Page 49: ...en when the Delay Start infusion begins the display changes to the Main Display When a Delay Start infusion has been programmed a wristwatch icon is displayed on the Main Display screen Figure 2 14 until it is time for the infusion to begin When a Delay Start infusion begins the pump channel s infusion mode changes to primary rate volume and the main display shows the programmed infusion informati...

Page 50: ...2 Infusion Modes 2 26 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 51: ...condensing Barometric Pressure 70 to 106 kPa Setup Instructions Initial Installation To ensure safe and proper operation read the manual and any instructions accompanying disposables or accessories before operating this device To charge a new pump s batteries 1 Plug the power cord into a 100 120 VAC 50 60 Hz or 220 240 VAC 50 60 Hz outlet 2 Confirm that the plug icon is lit This indicates that the...

Page 52: ...nly Note To help loosen the mounting clamp knob flip open and use the two wing shaped extensions on the knob 1 Check to see if the clamp bracket is positioned for headboard mounting or other horizontal applications as in Figure 3 2 If so continue with Step 2 otherwise see Changing the Mounting Bracket Orientation Single Channel Pumps Only 3 3 2 Attach mounting clamp by positioning the hinged clamp...

Page 53: ...is towards the floor see clamp in Figure 3 2 4 Slide the clamp up onto the plate until you hear the clamp lock into place D in Figure 3 3 The clamp should now be positioned as in Figure 3 2 5 Continue with attaching the clamp according to the applicable mounting procedure above Check out Perform the following visual inspections before each use Display screens and keypads check for wear scratches o...

Page 54: ...3 Check out 3 4 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 55: ...VAC 50 60 Hz or 220 240 VAC 50 60 Hz properly grounded 3 wire receptacle Grounding reliability can only be achieved when the pump is connected to an earth grounded hospital grade receptacle When grounding reliability is in doubt the pump should be powered by its battery The Note Pump Status If the pump status is unclear close any pop up win dows on the display and press the Main Display key to con...

Page 56: ... LEDs or the plug icon are not lit or the battery icon is lit A series of three beeps with two different tones is not heard during self diagnostic test Audible speaker is not heard during speaker test Damaged Battery icon is displayed on power on screens If a Damaged Battery Service Now alarm occurs during power on the pump cannot be used See About the Damaged Battery Alarm 8 8 1 With the pump plu...

Page 57: ...til Yes and No soft keys are displayed Figure 4 2 3 Do one of the following 3 1 If the continuous tone is heard press the Yes soft key The pump completes its self test and then displays the Power On Screen After Self Test Figure 4 4 3 2 If the continuous tone is not heard even after adjusting the volume control press the No soft key The pump displays a pop up to confirm whether the continuous tone...

Page 58: ...me history press the New Patient soft key Pressing the Change Personality soft key changes the display to the Pump PERSONALITY feature set selection screen where available preconfigured pump parameters can be selected Changing the PERSONALITY feature set also clears the volume history and the programming parameter settings such as Rate and Volume to be Infused See Selecting a Pump PERSONALITY Feat...

Page 59: ...ets is displayed 2 Use the Ø keys to highlight the desired PERSONALITY feature set Figure 4 6 3 Press the Select soft key Viewing PERSONALITY Feature Settings at Power Up To view the settings for all the parameters of a PERSONALITY feature set 1 Turn the pump on then press the Change Personality soft key Use the Ø keys to highlight the desired PERSONALITY feature set then press the View Personalit...

Page 60: ...handle 2 Rotate the contrast control to increase or decrease the contrast as needed Powering On Using Battery Power Full Partial Battery Charge If the pump is powered up on battery power a Plug In Now pop up is displayed Figure 4 8 prior to the speaker test showing the approximate battery time remaining and prompting the user to plug the pump into an AC power outlet To continue on battery power pr...

Page 61: ...he user to perform the speaker test Proceed to step 2 on page 4 3 Depleted Battery Condition If the pump is powered up on battery power and a Depleted Battery condition exists a Plug In Now alarm pop up is displayed prior to the speaker test alerting the user that battery damage will occur if the pump is not plugged in and the pump will shut down in less than 10 seconds Figure 4 10 To continue on ...

Page 62: ... discharge at a faster rate at higher infusion rates If the flow rate is changed during an infusion the battery time remaining will change accordingly Battery Charge Icon Descriptions See Table 4 1 for a list of battery charge icons and their meaning Battery time remaining is approximate Figure 4 11 Battery Charge Icon on Main Display Table 4 1 Battery Charge Icons and Descriptions Icon Descriptio...

Page 63: ... charge is achieved When the battery time remaining is only 5 minutes the battery charge icon appears as an empty outline as shown at left The icon will remain an empty outline until the battery is depleted and pump shuts itself off If the pump s batteries need replacement when the pump is first powered on a Damaged Battery Service Now alarm occurs and this icon flashes on the Power On screen The ...

Page 64: ...approximate battery time remaining The pop up will reappear every hour counting down the battery time until the battery time remaining reaches 60 minutes Pressing the Ok soft key will silence the alert and clear the pop up however the status line will continue to show the message Running on Battery Plug In Now When the battery time remaining reaches 60 minutes the Limited Battery Plug In Now alert...

Page 65: ...up but will not silence the audible tone Pressing the Alarm Silence key will silence the tone for two minutes The status line will continue to show the message LOW Battery Plug In Now When the battery time remaining reaches 5 minutes the DEPLETED Battery Plug In Now alert occurs An audible tone sounds and a Plug In Now pop up window displays Figure 4 15 alerting the user that infusions will stop i...

Page 66: ...ry power until the batteries have been fully recharged Charge the battery for at least 12 uninterrupted hours or until the battery operating time displayed under the battery charge icon in the upper left part of the screen is 3h 15m for triple channel pumps or 4h 00m for single channel pumps A complete charge may take longer than 12 hours Battery Charge Progress Indicator Alert When the pump is pl...

Page 67: ...set change interval For optimal pump performance set use should not exceed the change interval shown on the set s label copy or 72 hours whichever is less WARNING Clinicians are advised to verify the proper route of delivery and that the infusion site is patent When using this pump periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected The pump is capab...

Page 68: ...4 18 3 Ensure all air is expelled from the administration set 4 Close the regulating clamp on the administration set WARNING The pump may not detect an upstream occlusion if one or more of the following conditions exist All air removed from the source container Incomplete insertion of the spike into the source container Improper venting of a rigid glass bottle or semi rigid plastic container inclu...

Page 69: ...aying the infusion source container flat during an infusion increases the potential for air to enter the tubing resulting in an Air in Line alarm and interruption of patient therapy WARNING Use only Baxter standard administration sets equipped with keyed slide clamps that are labeled as being COLLEAGUE pump compatible or denoted with an s in the product code If you have questions about administrat...

Page 70: ...istration set Before loading the set into the pump position the keyed slide clamp at an appropriate location along the tube segment to ensure that there is adequate length of tubing between the patient and the pump to reduce tugging on the set Lastly ensure there is sufficient slack in the tubing between the distal end of the tubing channel and the patient to prevent tube tugging during activities...

Page 71: ...onfirm that the tubing coming from the source container enters the pump module on the left side and the tubing exiting the pump on the right side goes to the patient as shown in Figure 4 20 6 Open the regulating clamp Verify that no solution is flowing no free flow drops falling in the drip chamber and or no flow from the end of the administration set 7 Attach the primed administration set to the ...

Page 72: ...ed Priming the Administration Set Note The administration set s drip chamber should be at least one third full prior to using the prime function to ensure that fluid will enter the administration set Note Prime cannot be selected if an Air alarm is active Note Air detection is disabled when priming is active WARNING If flow is observed when tubing is loaded but the pump is not running close the re...

Page 73: ... the Programming screen 3 From the Programming screen press the Change Mode soft key The Programming Modes menu is displayed Figure 4 21 4 Use the Ø keys to highlight Prime under Functions then press the Select soft key The PRIME WARNING pop up Figure 4 22 is displayed Figure 4 21 Programming Modes Menu For single channel pumps For triple channel pumps press the Primary soft key or the Rate or Vol...

Page 74: ... the air is expelled from the administration set The PRIME ACTIVE pop up Figure 4 23 is displayed while the Prime soft key is pressed Release the Prime soft key when finished priming 6 When priming has been completed press the Done soft key to exit the priming function and return to the channel s primary infusion program screen Figure 4 23 Prime Active ...

Page 75: ...hese alarms Primary Infusions Programming a Primary Rate Volume Infusion 1 From the Main Display screen Figure 4 24 The display then changes to the Rate Volume programming screen Figure 4 25 The Rate field is highlighted Figure 4 24 Main Display Screen For single channel pumps For triple channel pumps press the Primary soft key or the Rate or Volume keys press the desired Channel Select key Note C...

Page 76: ...pears Figure 4 26 warning that a primary infusion is about to start when a secondary infusion has been programmed Press the Done soft key to clear the warning and do one of the following Press the Secondary soft key to access the secondary infusion programming screen For more information about secondary infusions see Secondary Infusions 4 45 Press the START key again to start the primary infusion ...

Page 77: ...s then press the Select soft key A list of labels and their abbreviations is displayed as shown in Figure 4 29 If the list consists of more than one screen use the Page Up and Page Down soft keys to view the next screen of labels Figure 4 27 Main Display Primary Running Note Programming Tips If an incorrect value is entered during programming press the CLR key to clear the field then enter the cor...

Page 78: ...ows the label Maintenance Line highlighted on the list of available labels Figure 4 29 Label List Note COLLEAGUE GUARDIAN Labels Labels configured using the COLLEAGUE GUARDIAN feature do not appear in the label list Note Clearing Labels To clear a label use the same procedure but select No Label from the label list No Label always appears first in the label list Note Appropriate Label Use Confirm ...

Page 79: ...ation must be less than or equal to 99 59 If a time greater than 99 59 is entered is displayed 6 Verify that the values are appropriate After the time duration is programmed the Volume to be infused or Rate can be changed The pump then calculates the new time duration automatically 7 Press the Confirm Primary soft key 8 Press the START key to start the infusion If a secondary infusion has been pro...

Page 80: ...Infusion Rate Volume 1 From the Main Display access the Programming screen 2 From the Programming screen press the Colleague Guardian soft key Figure 4 32 For single channel pumps For triple channel pumps press the Primary soft key or the Rate or Volume keys press the desired Channel Select key Figure 4 32 Colleague Guardian Soft Key ...

Page 81: ...l indicates that the standard concentration can be edited if clinically necessary 3 Use the Ø keys and Page Up Page Down soft keys if necessary to highlight the desired label then press the Select soft key The programming mode changes to the mode configured for the selected label and the Rate field is filled with the configured value Figure 4 34 Figure 4 33 COLLEAGUE GUARDIAN Label List Figure 4 3...

Page 82: ... container and administration route for the programmed infusion 9 Then press the Confirm Primary soft key If the values entered result in a dose that is outside the COLLEAGUE GUARDIAN rate limits a Limits Warning pop up is displayed showing the flow rate entered and the defined rate limits Figure 4 36 If this occurs do one of the following Press Cancel Rate Ø key to cancel the rate and return to t...

Page 83: ...ss the Colleague Guardian soft key The labels for which COLLEAGUE GUARDIAN limits have been configured are displayed in a pop up window Figure 4 38 A yellow triangle beside the label indicates that the standard concentration can be edited if clinically necessary 3 Use the Ø keys and Page Up Page Down soft keys if necessary to highlight the desired label then press the Select soft key Figure 4 37 I...

Page 84: ...overridden 5 Optional If the label is set up to allow non standard concentration programming the drug amount diluent volume and concentration can be changed by using the Ø keys to highlight the appropriate field and entering new values using the numeric keypad 6 Use the Ø key to highlight the Dose field 7 Enter the desired dose or change the default dose if clinically appropriate using the numeric...

Page 85: ...istration route for the programmed infusion 9 Press the Confirm Primary soft key If the values entered result in a dose that is outside the COLLEAGUE GUARDIAN dose limits a Limits Warning pop up is displayed showing the calculated dose and the dose limits Figure 4 42 If this occurs do one of the following Press Cancel Dose Ø key to cancel the dose and return to the programming screen then enter a ...

Page 86: ...gramming screen 2 From the Programming screen press the Colleague Guardian soft key The labels for which COLLEAGUE GUARDIAN limits have been configured are displayed in a pop up window Figure 4 44 A yellow triangle beside the label indicates that the standard concentration can be edited if clinically necessary 3 Use the Ø keys and Page Up Page Down soft keys if necessary to highlight the desired l...

Page 87: ... or ounces if appropriate To change weight units highlight the Weight field press the Units soft key to display the weight units list Figure 4 46 highlight the desired weight unit then press the Select soft key 5 Enter patient weight using the numeric keypad Depending on how the pump has been configured at the facility the kg or lbs field may not be available for data entry Fields not available fo...

Page 88: ...imits soft key Press the Done soft key to close the pop up and continue Concentration limits cannot be overridden 9 Optional If the label is set up to allow non standard concentration programming the drug amount diluent volume and concentration can be changed by using the Ø keys to highlight the appropriate field and entering new values using the numeric keypad Figure 4 47 Calculated Values Figure...

Page 89: ...the preset limits If the clinical decision is to proceed with the override of the COLLEAGUE GUARDIAN limits press Accept Dose key to accept the out of limits dose and continue with the infusion as programmed Figure 4 49 Non Standard COLLEAGUE GUARDIAN Programming Weight Based Note Weight Differences Triple Channel Pumps Only The pump will detect weight differences and display a pop up window for t...

Page 90: ... Display access the Programming screen 2 From the Programming screen press the Change Mode soft key The Programming Modes menu is displayed Figure 4 51 3 Use the Ø and or Page Up Page Down soft keys to highlight the appropriate dose formula selection if configured Some or all of the following dose modes may be available depending on pump configuration at the facility Colleague Guardian mg hr mg mi...

Page 91: ...r new values or press the CLR key for each value 5 Check the units of measure displayed for the Drug Amount To enter the drug amount in units other than the one displayed 5 1 Press the Units soft key to display the Units Change list Figure 4 53 5 2 Use the Ø keys to highlight the desired units 5 3 Press the Select soft key to change to the highlighted units 6 Enter the desired Drug Amount using th...

Page 92: ...ts to the Diluent Volume The Volume to be infused may be less than the Diluent Volume but cannot be greater than the Diluent Volume 11 If appropriate change the Volume to be infused value Figure 4 54 Value High Prompt Note Concentration Too High The pump calculates the concentration as diluent vol ume is entered In Figure 4 54 the concentration is too high because the pump is calculating as the nu...

Page 93: ...te START key to begin the infusion The Main Display screen shows the rate volume remaining and the dose Figure 4 57 If a secondary infusion has been programmed but not started a pop up appears Figure 4 26 warning that a primary infusion is about to start when a secondary infusion has been programmed See step 7 on page 4 22 for more information Figure 4 56 Unconfirmed Primary Program Note Unconfirm...

Page 94: ...igure 4 58 3 Use the Ø and or Page Up Page Down soft keys to highlight the appropriate dose mode selection Figure 4 59 Some or all of the following dose modes may be available depending on pump configuration at the facility mcg kg min mg kg hr mEq kg hr mg kg min mcg kg hr units kg hr For single channel pumps For triple channel pumps press the Primary soft key or the Rate or Volume keys press the ...

Page 95: ...the parameters enter new values or press the CLR key for each value 5 Check the units of measure displayed for the Drug Amount To enter the drug amount in units other than the one displayed 5 1 Press the Units soft key to display the Units Change list Figure 4 61 5 2 Use the Ø keys to highlight the desired units 5 3 Press the Select soft key to change to the highlighted units 6 Enter the desired D...

Page 96: ...small patients weight can be entered in grams or ounces if appropriate Highlight the Weight field press the Units soft key to display the weight units list Figure 4 63 highlight the desired weight unit then press the Select soft key Figure 4 62 Value High Prompt Note Concentration Too High The pump calculates the concentration as diluent vol ume is entered In Figure 4 62 the concentration is too h...

Page 97: ...gramming matches the label on the source container and the physician s order that the loaded administration set is connected to the correct source container and administration route for the programmed infusion 14 Press the Confirm Primary soft key Figure 4 64 Example of Out of Range Weights Note Weight Limits The pump is capable of accepting patient weights within the range 0 2 to 600 kg 0 44 to 1...

Page 98: ... weight differences and display a pop up window for the following If a patient weight is entered on one channel and a different patient weight is entered on another channel If a patient weight is entered on one channel and the same patient weight is entered on another channel using different units lbs on one channel and kg on the other for example and the units conversion causes the weights to app...

Page 99: ...ned from the primary source container during infusions causing concurrent flow WARNING Use only CONTINU FLO standard administration sets equipped with keyed slide clamps and labeled as COLLEAGUE pump compatible or denoted with an s in the product code as the primary fluid line when administering a secondary medication solution See Recommended Administration Sets 4 15 Carefully follow the direction...

Page 100: ...accompany the source container and administration sets you are using Carefully follow any label copy instructions for loading removing and reloading the set as well as the recommended set change interval For optimal pump performance set use should not exceed the change interval shown on the set s label copy or 72 hours whichever is less WARNING COLLEAGUE pumps do not support same bag loading dose ...

Page 101: ...pump close the regulating clamp Open the On Off clamp on the secondary medication solution set and press the START key If a primary infusion has been programmed but not confirmed an Unconfirmed Primary Program alarm occurs and a message is displayed on the prompt line Complete the following Press the Primary soft key to review the primary infusion program For more information about primary infusio...

Page 102: ...rimary container will occur when the secondary container empties After the secondary volume remaining reaches zero the program automatically reverts to the primary rate or to a KVO Keep Vein Open rate if no primary infusion has been programmed Figure 4 69 Main Display Secondary Running Note Programming Tips If an incorrect value is entered during programming press the CLR key to clear the field th...

Page 103: ...Confirm Secondary soft key is pressed the calculated time is displayed as Time Remaining instead of the time duration entered The time duration must be less than or equal to 99 59 If a time greater than 99 59 is entered is displayed 6 When all infusion parameters have been entered verify that pump programming matches the label on the source container and the physician s order the loaded administra...

Page 104: ... the clinician uses the Ø key to highlight the Callback field then selects Yes or No for using the callback option by pressing the Yes No soft key Figure 4 72 To cancel this alert press the Alarm Silence key or any of the programming keys If Callback is not displayed on the secondary programming screen this feature has not been enabled Standby Mode The Standby mode allows the user to preprogram a ...

Page 105: ...Optional To preprogram the pump for future use program the infusion but do not press the START key 3 From the Programming screen press the Change Mode soft key The Programming Modes menu is displayed Figure 4 73 4 Use the Ø keys to highlight Standby then press the Select soft key The Standby pop up is displayed Figure 4 74 5 Press the key next to the YES shown on the pop up to place the pump into ...

Page 106: ...e Channel Pumps Note Channels B and C are on Standby when the device is first powered on 1 Ensure the pump channel is stopped Press the Channel Select key for the channel to be put on Standby 2 Optional To preprogram the channel for future use program the infusion but do not press the START key 3 Press the Channel Select key again The Standby pop up is displayed Figure 4 76 4 Press the key next to...

Page 107: ...cted while programming the standby infusion the label is also shown Figure 4 77 Programming Modes Menu Note Alternate Standby Method Standby can also be selected from the Programming Modes menu Figure 4 77 After Channel Select is pressed step 1 above press the Change Mode soft key then use the Ø keys to highlight Standby and press the Select soft key The Standby pop up is dis played Figure 4 76 Co...

Page 108: ...s displayed 3 Use the Ø keys to highlight Primary Delay Start from the Programming Modes menu Figure 4 79 then press the Select soft key For single channel pumps For triple channel pumps press the Primary soft key the Rate key or the Vol key press the desired Channel Select key Note Reconfirm Programming After exiting Standby all confirmed programming will require an additional confirmation Press ...

Page 109: ...he Done soft key when the time or date is changed The channel s Primary Delay Start programming screen Figure 4 81 is displayed 5 Using the numeric keypad enter the desired infusion rate for the delayed infusion in the Rate field 6 Press the Vol key or the Ø key to highlight the Volume to be infused field 7 Use the numeric keypad to enter the desired volume to be infused for the delayed infusion 8...

Page 110: ...y Start infusion so it will begin at the programmed start time The screen displays the wristwatch icon and the programmed start time for the Delay Start infusion Figure 4 83 Viewing Delay Start Settings Prior to the Start of Infusion To view preprogrammed Delay Start settings prior to the start of the infusion Figure 4 82 Delay Start Infusion Programming Note Optional Labels To add an optional lab...

Page 111: ...he pump channel s STOP key The Start At time hours are cleared Delay Start is still the active infusion mode but the infusion has not been completely programmed For single channel pumps For triple channel pumps press the Primary soft key or the Rate key press the desired Channel Select key Note Changing Infusion Information If the Rate or Volume to be Infused is changed the Start At information is...

Page 112: ...the infusion has not been completely programmed The Delay Start mode will be cancelled by using the Change Personality pop up and pressing the Select soft key or by pressing the New Patient soft key Note Delay Start and Standby A completely programmed Delay Start infusion may not be placed into Standby If the pump channel is placed into Standby with a completely programmed Delay Start infusion the...

Page 113: ...he Volume History screen reverts to the previously displayed screen if no keys are pressed for 30 seconds Figure 4 84 Volume History Screen For single channel pumps For triple channel pumps press the Clear All soft key to clear volume history for the entire device if desired then press the Done soft key to return to the previous screen press the Clear All soft key to clear volume history for the e...

Page 114: ...sing at the previous rate Figure 4 85 Enter New Rate For single channel pumps For triple channel pumps press the Primary soft key or the Rate key press the desired Channel Select key Note Secondary Infusions If a secondary infusion is running secondary icon is displayed the secondary Rate field is highlighted To change the primary rate stop the secondary infusion then press the Primary soft key Pr...

Page 115: ...nfusion using the new dose If the START key is not pressed the pump continues infusing at the previous dose Changing Volume Weight or Concentration During an Infusion Use this procedure to change volume to be infused patient weight or concentration of the infusion currently shown on the display Figure 4 87 Primary Programming Screen Infusion Running For single channel pumps For triple channel pump...

Page 116: ...usion is running secondary icon is displayed the secondary Rate field is highlighted To change primary infusion parameters stop the second ary infusion then press the Primary soft key Primary infusion programs cannot be altered while a secondary infusion is running Note Changing Concentration If the Concentration field is changed the pump forces the Drug Amount and Diluent Volume to be entered If ...

Page 117: ...n one screen use the Page Up and Page Down soft keys to view the next screen of labels 4 Highlight the label to be selected using the Ø keys then press the Select soft key When the Select soft key is pressed the Programming screen is displayed showing the selected label 5 Press the START key to resume the infusion Viewing COLLEAGUE GUARDIAN Limits During an Infusion Use this procedure to view the ...

Page 118: ...reen For single channel pumps For triple channel pumps press the Primary soft key or the Rate or Volume keys press the desired Channel Select key Figure 4 92 View Limits Soft Key Figure 4 93 Limits Display Pop up Note Changing COLLEAGUE GUARDIAN Labels To change to a different COLLEAGUE GUARDIAN drug label the infusion must first be stopped Press the STOP key on the desired pump channel then press...

Page 119: ...the secondary infusion is running The Rate field is highlighted Figure 4 94 2 Enter a new value using the keypad The pump clears the Time Remaining value 3 Press the Confirm Secondary soft key 4 Press the START key to begin infusing at the new rate If the START key is not pressed the pump continues infusing at the previous rate Figure 4 94 Enter New Secondary Rate For single channel pumps For trip...

Page 120: ... are met no alarms or alerts are present for single channel pumps an infusion is running for triple channel pumps all infusions are running or up to two infusions are on Standby Panel Lockout cannot be enabled if all three pump modules are on Standby To enable the panel lockout function press the PANEL LOCKOUT button located on the back of the pump The Lock icon is displayed between the second and...

Page 121: ...priate pump module A stop icon displays on the Main Display Figure 4 97 and the RUNNING LED is no longer illuminated for that channel The pump module displays STOPPED If the pump is not restarted within two minutes or no keys are pressed for 30 seconds a Channel Stopped alert will sound Figure 4 97 Infusion Stopped Note Do not cut the tubing to remove the administration set from the channel If the...

Page 122: ...primary set if applicable open the On Off clamp on the secondary administration set and For single channel pumps For triple channel pumps press the Primary soft key then press the START key press the Channel Select key on the desired pump channel then press the START key Figure 4 98 Secondary Stopped For single channel pumps For triple channel pumps press the Primary soft key then press the START ...

Page 123: ...whichever is less See Configurable Options 6 1 To exit the alert press the STOP key on the appropriate pump channel and program the pump for the next infusion if appropriate place the channel in standby or power off the pump Figure 4 99 KVO Display Note Standby Triple Channel Pumps For triple channel pumps If other channels are being used this pump channel should be placed in Standby mode so that ...

Page 124: ...mechanism closes automatically 60 seconds after the administration set has been removed The administration sets should be disposed of in an appropriate manner considering the nature of the residual fluid that may be contained within in accordance with the facility disposal practices WARNING While the pump automatically closes the keyed slide clamp always close the regulating clamp on the administr...

Page 125: ...ee Figure 4 100C This closes the keyed slide clamp and opens the pump mechanism 5 Remove the administration set from the pump The Reset Manual Tube Release screen may not display if a pump failure has occurred If the pump is on with no administration set in the tubing channel a Reset Manual Tube Release alarm occurs and the Reset Manual Tube Release screen is displayed Figure 4 101 If the pump is ...

Page 126: ...into its socket 3 For triple channel pumps Repeat the steps above as needed for additional channels 4 The Done soft key is displayed when the Manual Tube Release is reset for all affected channels Press the Done soft key to clear the alarm Figure 4 101 Reset Manual Tube Release Pop up Note MTR After Channel Failure If the Manual Tube Release is used following a chan nel failure to remove the admin...

Page 127: ...eted battery the pop up window alerts the user to that condition Figure 4 103 To resume operation press the Return soft key WARNING While the pump automatically closes the keyed slide clamp always close the regulating clamp on the administration set before loading or removing the administration set from the pump Figure 4 102 Standard Power Off Pop up Figure 4 103 Battery Power Off Pop ups Power Of...

Page 128: ...d required Note Panel Lockout The ON OFF CHARGE key is disabled if the front panel is locked Press the PANEL LOCK button on the back of the pump to unlock the panel then power off the pump Note MTR If a Manual Tube Release has been used due to a channel failure the Manual Tube Release pop up will be displayed prior to power off Any open Manual Tube Release s must be fully reset before the device c...

Page 129: ...minutes and a battery charge icon shows an indication of the current battery charge level See Battery Charge Icon Descriptions 4 8 for more information about the battery charge level icons To exit the Options Menu and return to the Main Display screen press the Done soft key or the Main Display key Managing Occlusion Settings When enabled the clinician can temporarily modify the downstream occlusi...

Page 130: ...turn to the Main Display Screen If the Options Menu is used to modify the Downstream Occlusion values the override values are not permanently saved When the pump is powered off the downstream occlusion values revert to the configuration defined by the facility Auto Restart When configured by facility authorized personnel the Auto Restart option enables the pump to automatically restart itself when...

Page 131: ... Configurable Options 6 1 for factory settings Using Flow Check Display The Flow Check display feature provides a visual indication of downstream resistance to flow for each pump channel The Flow Check display appears on the Main Display screen Resistance to flow is indicated by the number of filled triangles One filled triangle indicates normal conditions If Flow Check is enabled in the currently...

Page 132: ... 3 To exit the Options Menu press the Done soft key or the Main Display key to return to the Main Display screen Using the Configuration Service Function This function is for use by Baxter trained qualified personnel only Accessing this function requires a passcode Figure 4 110 See the COLLEAGUE Pump Global Service Manual and the COLLEAGUE Pump Configuration Manual for details Figure 4 109 Flow Ch...

Page 133: ...rovided with the Syringe Adapter and syringe adapter administration set This accessory is suitable for use in the patient environment WARNING The use of accessories and cables other than those specified in this manual with the exception of cables sold by Baxter as replacement parts for internal components may result in increased emissions decreased immunity or may result in operation that is not w...

Page 134: ...RDIAN Feature The pump should not be connected to a patient while the COLLEAGUE GUARDIAN Configuration Tool is in use it is not suitable for use in the patient environment COLLEAGUE DL2 Event History Download Application The COLLEAGUE DL2 Event History Download Application Baxter product code 2M9530 is a PC based tool that allows the event history information from COLLEAGUE pumps to be downloaded ...

Page 135: ... by facility authorized personnel To change settings an access code is required To create a custom PERSONALITY feature set or to change initial factory settings see the COLLEAGUE Pump Configuration Manual or the COLLEAGUE Guardian Configuration Tool User s Guide The PERSONALITY feature set named Permanent Settings cannot be changed Note Authorized healthcare professionals should establish the sett...

Page 136: ... using the COLLEAGUE GUARDIAN feature Custom labels can then be enabled or disabled individually for each PERSONALITY feature set No custom labels defined COLLEAGUE GUARDIAN Feature For all predefined medication labels and custom labels in the pump s label library programming limits can be configured which will result in warnings to the clinician if they try to program parameters which exceed the ...

Page 137: ...ionally a default rate can also be entered mg hr mg min mcg hr mcg min units hr mEq hr mg kg hr mg kg min mcg kg hr mcg kg min units kg hr mEq kg hr Drug Amount Any amount within the pump s specifications The values are recalculated as values are entered for the other parameters If the resulting value is outside the pump s capabilities High or Low is displayed Diluent Volume Any amount within the ...

Page 138: ...ble Unavailable Disable Enabled Dose Infusion Modes Available Enable Unavailable Disable Enabled Individual dose formulas mg hr mg min mcg hr mcg min units hr mEq hr mg kg hr mg kg min mcg kg hr mcg kg min units kg hr mEq kg hr When Dose Infusion Modes is enabled individual modes can be enabled or disabled Enabled Enabled Enabled Enabled Enabled Disabled Enabled Enabled Enabled Enabled Enabled Dis...

Page 139: ...te limit whichever is less 1200 mL hr Volume To Be Infused Limit 0 1 mL to 9999 mL 9999 mL KVO Rate Limit 0 1 mL hr to 5 mL hr Pump infuses at the preselected KVO rate or the programmed rate whichever is lower Cannot exceed the infusion rate limit 5 mL hr Air Alarm Sensitivity Measured accumulations of approximately 25 Microliters 50 Microliters 100 Microliters 150 Microliters 150 Microliters Nomi...

Page 140: ...djustment of time between audible tones 1 second Auto Lock Available Enable Unavailable Disable Disabled Label Library Feature Available Enable Unavailable Disable Enabled Select Available Labels YES Enable NO Disable Note Individual labels can be enabled or disabled using the Library Setup soft key Note If labels have been configured using the COLLEAGUE GUARDIAN feature those labels must also be ...

Page 141: ...acility Note If a label is configured using the COLLEAGUE GUARDIAN fea ture it is selectable from the COLLEAGUE GUARDIAN list and is not displayed in the Label Line list Predefined Labels Table 6 4 is a list of the predefined medication labels and abbreviations available within the label library configuration setup Table 6 4 Predefined Medication Labels Name Abbreviation Abciximab ABCIXIMA Alfenta...

Page 142: ...enol ISPROTER Ketamine KETAMINE Labetalol LABETALO Lidocaine LIDOCAIN Magnesium Sulfate MAGNESIU Methohexital METHOHEX Methotrexate METHOTRE Midazolam MIDAZOLA Milrinone MILRINON Mivacurium MIVACURI Morphine Sulfate MORPHINE Naloxone NALOXONE Nicardipine NICARDIP Nitroglycerin NITROGLY Nitroprusside NITROPRU Norepinephrine NOREPINE Octreotide OCTREOTI Oxytocin OXYTOCIN Paclitaxel PACLITAX Table 6 ...

Page 143: ... with the application labels Phenylephrine PHENYLEP Plicamycin PLICAMYC Procainamide PROCAINA Propofol PROPOFOL Prostaglandin E1 PROSTAGL Rocuronium ROCURONI Sufentanil SUFENTAN Tirofiban TIROFIBA Vecuronium VECURONI Table 6 4 Predefined Medication Labels continued Name Abbreviation Table 6 5 Predefined Application Labels Name Abbreviation Application Labels Antibiotic ANTIBIOT Arterial Line ARTER...

Page 144: ... select from the predefined and custom labels Custom labels appear in the list in alphabetical order See the COLLEAGUE Pump Configuration Manual or the COLLEAGUE Guardian Configuration Tool User s Guide for instructions on configuring custom labels Maintenance Line MAINTENA Subcutaneous SUBCUTAN Total Parenteral Nutrition TPN Umbilical Arterial Catheter UAC Umbilical Venous Catheter UVC Table 6 5 ...

Page 145: ...y Baxter trained qualified personnel to minimize potential difficulties caused by fluid pooling and drying on the mechanism Fluid in the tubing channel can also cause false Air In Line alarms See Authorized Service Centers 10 2 CAUTION Do not clean disinfect or sterilize any part of the pump by autoclaving or with ethylene oxide gas Doing so may damage the pump and void the warranty Only external ...

Page 146: ...ng solutions listed below 70 0 Isopropanol IPA alcohol 2 7 Sodium hypochlorite bleach diluted with 90 water to create a 10 bleach solution 3 0 Hydrogen peroxide Final concentration is 3 1 7 g Sodium dichloroisocyanurate tablets Use blood concentration or 10 tablets per liter of water 10 000 PPM chlorine Isopropanol 17 2 Disobutylphenoxyethyl dimethyl benzyl ammonium chloride 0 28 No further diluti...

Page 147: ... cord Check the cord and connectors for cracks and damage Do not use the pump if the connectors appear damaged Feet Verify that the feet are free of cuts or deterioration and that they are securely fastened Rear housing Verify that there are no loose or missing parts and that connectors and accessories are undamaged Contrast and Volume controls Verify that both controls are undamaged and rotate fr...

Page 148: ...ten a lead acid battery is discharged to a low battery or deep discharge state the sooner it requires replacement Leaving batteries in a discharged condition If the batteries have been discharged do not store the pump without first fully charging the batteries The batteries may be permanently damaged if the pump is stored unplugged with discharged batteries for more than two weeks If a Damaged Bat...

Page 149: ...minimum of 12 uninterrupted hours or until the battery operating time displayed under the battery charge icon in the upper left part of the screen is 3h 15m for triple channel pumps or 4h 00m for single channel pumps A complete charge may take longer than 12 hours Charging the Batteries When a NO BATTERY Plug in Now alarm occurs plug the pump in immediately Do not use the pump on battery power unt...

Page 150: ...wer cord plugged into an AC outlet to maintain the batteries at full charge whenever possible Doing so will maintain the batteries at full charge If the batteries have been discharged do not store the pump without first fully charging the batteries The batteries may be permanently damaged if the pump is stored unplugged with discharged batteries for more than two weeks To help prolong battery life...

Page 151: ...rmed to room temperature before using the pump When unpackaged ensure the pump is stored in a clean and dry 20 95 RH non condensing environment to safeguard against prolonged exposure to dust and moisture In conditions falling outside the Environmental Operating Limits see Technical Specifications 9 1 Baxter recommends that the pump be repackaged in the original shipping materials ...

Page 152: ...7 Storage 7 8 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 153: ...etical order Active alert alarm and failure messages are displayed on the status line at the top of the Main Display Figure 8 1 An abbreviated form of the message is also shown on the pump module display Figure 8 1 Main Display Status Line Note Messages on a triple channel pump For triple channel pumps two status lines may be dis played Channel identifiers A B C accompany the messages STATUS LINE ...

Page 154: ...ning on the device When a device failure has occurred follow the directions below 1 Close the regulating clamp on the administration set Unload the administration set see Step 5 on page 8 3 for single channel pumps or Step 4 on page 8 6 for triple channel pumps 2 Request a replacement pump immediately 3 Cycle power on the pump by powering off and then powering on again Do this only once 4 Based on...

Page 155: ...echanism in the closed position Close the regulating clamp on the administration set Press the Open key If the mechanism opens remove the set If the mechanism does not open or if the device has been powered off due to depleted batteries use the Manual Tube Release to remove the set see Using the Manual Tube Release 4 71 Figure 8 2 Channel Failure Status Line Display Note Failures occurring on batt...

Page 156: ... set into the same channel open the regulating clamp and continue using the pump 9 Monitor the pump until replacement pump arrives and transfer any infusions to the replacement pump as soon as it is clinically safe 10 Have the failed pump serviced as soon as possible according to instructions provided in the COLLEAGUE Pump Global Service Manual Figure 8 4 Channel Out of Service Display Note Using ...

Page 157: ...will be displayed on the Main Display the ALARM LED will light and the audible tone will occur Note Using Manual Tube Release Use Manual Tube Release only when the Tube Load ing Mechanism is NOT functioning or if a channel fail ure occurs If the Manual Tube Release is used when the pump channel is functioning normally program ming either of the remaining pump channels is not pos sible until the Ma...

Page 158: ...e device has been powered off due to depleted batteries use the Manual Tube Release to remove the set see Using the Manual Tube Release 4 71 5 Press the Done soft key The Main Display shows that the pump channel is out of service Figure 8 7 6 Allow any infusions running on the other pump channels to complete The failed pump channel cannot be used to deliver infusions but the Volume History key can...

Page 159: ... two minutes press the Alarm Silence key Note How alarms appear on the pump module display Selected label information may alternate with an abbre viation of the alarm message shown in the status line on the pump module display Alternating messages are represented in this chapter by using a mark between the pump module message and the label For example AIR label indicates that the AIR alarm message...

Page 160: ...by replacing the batteries Turn the pump off plug it in and have it serviced as soon as possible so its batteries can be replaced Use a different pump to deliver the infusion The pop up shown in Figure 8 8 will also appear if the pump detects that the battery is damaged when powered on but not in use If the pump detects that the battery is damaged during an infusion the Damaged Battery Service Now...

Page 161: ...te length of tubing between the patient and the pump to reduce tugging on the set Lastly ensure there is sufficient slack in the tubing between the distal end of the tubing channel and the patient to prevent tube tugging during activities such as moving the patient from one bed to another or transportation of the patient from one facility location to another In order to avoid false alarms the pump...

Page 162: ... primary infusion or KVO mode If pump assisted viewing of the detected air is not desired press the Ø key No to manually purge the air Remove the administration set as described in Unloading the Administration Set 4 70 and remove the air from the tubing in accordance with the recommended practice of the facility When manual purge has been completed go to Step 5 of these instructions Pressing the N...

Page 163: ...infusing Figure 8 12 4 Press the Done soft key The Air Detected alarm is reset Visually inspect the air and follow the facility s procedures for manually removing the air 5 After the air has been removed the infusion may be restarted Press the Primary or Secondary soft key to access the appropriate programming screen and then press the START key Figure 8 11 Fluid Detected Figure 8 12 Fluid Detecte...

Page 164: ...e Advance Air Limit screen is displayed Fig ure 8 13 and the Advance Air soft key is disabled Remove the administration set from the pump and remove the air manually WARNING While the pump automatically closes the keyed slide clamp always close the regulating clamp on the administration set before loading or removing the administration set from the pump Note Alarm Alert messages on triple channel ...

Page 165: ...r on the pump cannot be used See About the Damaged Battery Alarm 8 8 for more information X Downstream Occlusion DWN OCCL label A closed clamp stopcock clogged filter or other occlusion is preventing fluid flow between the pump and patient Correct the problem causing the occlusion Restart the infusion for single channel pumps press the Primary or Secondary soft key to access the appropriate progra...

Page 166: ...een pressed for longer than 5 seconds Do one of the following as appropriate Release the button Relocate any objects next to the pump that may be pressing the button Ensure the pump s power cord is not wrapped around the pump in such a way as to press the button If unresolved for more than 50 seconds a failure will result X Primary Out of Range X Secondary Out of Range STOPPED A programming value ...

Page 167: ...oading action to complete then press the START key X Tube Misloaded PATIENT The administration set is improperly loaded The administration set was not fully removed from the tubing channel A hardware problem may have occurred Close the regulating clamp on the administration set and remove the administration set See Unloading the Administration Set 4 70 If alarm occurs again a hardware problem may ...

Page 168: ...he pump for closed clamps or kinks Ensure that BURETROL administration sets or source containers are vented Restart the infusion for single channel pumps press the Primary or Secondary soft key to access the appropriate programming screen and then press the START key for triple channel pumps press the Channel Select key to access the appropriate programming screen and then press the START key Tabl...

Page 169: ...dule alert message The pump s battery requires replacement because it is nearing the end of its life The alert occurs when the pump detects that the battery has been charged and discharged 195 or more times This alert occurs even if the pump is plugged in Do not use the pump on battery power Send the pump for servicing as soon as possible so its battery can be replaced X Changing Secondary Program...

Page 170: ...an AC power outlet Switch the patient s infusions to another pump as soon as possible Do not use the pump for transport Send the pump for servicing This alert can be silenced but not cleared See Battery Charge Alerts and Alarms 4 10 for more information DEPLETED Battery Plug In Now BATTERY DEPLETED The pump s battery has been discharged to a level where it is depleted and less than 5 minutes of ba...

Page 171: ...ming or prior to completing a change to the rate or dose Enter the missing parameter value s and press the Confirm Primary or Confirm Secondary soft key followed by the START key Limited Battery Plug in Now no pump module alert message The pump is operating on battery power Approximate infusion time remaining on the batteries is displayed and decrements until the pump is plugged in Figure 8 17 If ...

Page 172: ... rate or the programmed rate whichever is lower Do one of the following as appropriate Prepare a new infusion For triple channel pumps stop the channel and place it in Standby mode Power off the pump X Priming PRIMING The Prime soft key is being pressed Release the Prime soft key after the set is primed X Programming Secondary xx x or xxx mL hr where xx x or xxx primary infusion rate Programming o...

Page 173: ...ts next to the pump that may be pressing the button Ensure the pump s power cord is not wrapped around the pump in such a way as to press the button Running on Battery Plug in Now no pump module alert message The pump is running on battery power Plug the pump into AC power as soon as possible to maintain battery charge See Battery Charge Alerts and Alarms 4 10 for more information X Secondary Call...

Page 174: ...nconfirmed Secondary Program no pump module alert message With a primary infusion running the START key was pressed prior to confirming programming information Press the Confirm Primary or Confirm Secondary soft key followed by the START key Table 8 2 Troubleshooting Alert Messages continued Alert Message Cause Recommended Action ...

Page 175: ...rth leakage tested per UL 60601 1 External Fuses 1 6 amp Type T time delay 250V Power Cord Approximately 2 7 m 9 feet long with integrally molded plug Battery Supply System For single channel pumps Fully charged new batteries typically provide approximately 4 hours of operation at 100 mL hr Battery run time is dependent on the channel flow rate and device clinician interaction For triple channel p...

Page 176: ...lb to 1322 lb in 1 lb increments Note For each PERSONALITY feature set patient weight range in kg and the units for patient weight entry lb or kg can also be configured within the limits specified above KVO 0 1 to 5 mL hr in 0 1 mL increments configurable option or programmed rate whichever is less Priming Rate 500 mL hr Note To be used only when the administration set is not connected to patient ...

Page 177: ...tion allows 0 to 9 restarts before manual intervention is required Delay Start Infusion parameters may be entered and the pump programmed to delay the start of the programmed infusion for up to 23 hours The infusion will start automatically when the programmed start time is reached Size Single channel pump is approximately 259 x 197 x 203 mm 10 2 H x 7 75 W x 8 0 D Triple channel pump is approxima...

Page 178: ...imits Transport 29ºC to 57ºC 20ºF to 135ºF 20 to 85 Relative Humidity non condensing 50 106 kPa Barometric Pressure Storage 15ºC to 40ºC 5ºF to 104ºF 20 to 95 Relative Humidity non condensing 70 106 kPa Barometric Pressure See Storage 7 6 for additional information Accessories Syringe Adapter Baxter product code 2D0300 COLLEAGUE GUARDIAN Configuration Tool Baxter product code 2M9541 COLLEAGUE DL2 ...

Page 179: ...t History Download Application The pump should not be connected to the patient when the COLLEAGUE Communication Cable is attached it is not suitable for use in the patient environment External Monitoring The External Monitoring feature is for Baxter diagnostic purposes only Recommended Practices Connections of this pump into the same patient line with other infusion systems or accessories may alte...

Page 180: ...ombinations of conditions that may involve but are not limited to the following position of the infusion container fluid density positive and negative pressure and the environment Flow fluctuations are most likely to occur when the conditions mentioned above are exacerbated or when the pump is operated in conditions outside of its normal limits See the Component Description Table on page 9 1 for d...

Page 181: ...mp may be erratic during the 120 minute startup period Therefore we have included the startup or stabilization data It should be noted that as the time interval over which accuracy is measured is lengthened all pumps show considerable improvement in flow accuracy Table 9 2 Accuracy Information Variable Condition Average Deviation Maximum Deviation Back Pressure 100 mmHg 4 1 6 9 100 mmHg 3 0 5 8 30...

Page 182: ...mum percentage error points corresponding to the 5 minute interval point on the Observation Interval axis you would be looking at the average flow variance for any 5 minute period throughout the infusion Similarly if you were to look at the 60 minute interval point on the Observation Interval axis you would be looking at the average flow variance for any 60 minute period throughout the infusion Ho...

Page 183: ...esirable to ensure that the deviations in plasma level also remained small The pump s ability to deliver very closely to the programmed rate would ensure that the drug s efficacy was being maintained In this example the medical professional would be wise to select a pump whose trumpet curve indicated a small or narrow range of deviations in flow rate Accuracy Tests Tested per Sub Clause 50 102 of ...

Page 184: ...19 31 min Figure 9 4 Trumpet Graph 2nd Hour of Delivery 1 mL hr 72nd Hour 1 4 1 2 1 0 0 8 0 6 0 4 0 2 0 0 Time minutes Qi mL hr 4260 4270 4280 4290 4300 4310 4320 Average of 8 pumps Figure 9 5 Flow Accuracy 72nd Hour 1 mL hr Average of 8 pumps 72nd Hour Q Flow Rate 1 04 A Accuracy 3 86 35 25 15 35 25 15 5 5 5 2 11 19 31 min Figure 9 6 Trumpet Graph 72nd Hour of Delivery 1 mL hr ...

Page 185: ...0 5 0 0 0 5 0 120 110 100 90 80 70 60 50 40 30 20 10 0 Figure 9 7 Delivery Startup First Two Hours 25 mL hr Average of 8 pumps 2nd Hour Q Flow Rate 25 02 A Accuracy 0 07 10 8 6 4 2 0 2 4 6 8 10 5 2 11 19 31 min Figure 9 8 Trumpet Graph 2nd Hour of Delivery 25 mL hr 72nd Hour Time minutes Qi mL hr 4260 4270 4280 4290 4300 4310 4320 Average of 8 pumps 50 0 45 0 40 0 35 0 30 0 25 0 20 0 15 0 10 0 5 0...

Page 186: ...etect Downstream Occlusions Average of 8 pumps 72nd Hour Q Flow Rate 25 32 A Accuracy 1 29 5 2 11 19 31 min 10 8 6 4 2 0 2 4 6 8 10 Figure 9 10 Trumpet Graph 72nd Hour of Delivery 25 mL hr Rate Occlusion Alarm Pressure Setting Typical Time to Alarm Activation Maximum Time to Alarm Activation 1 mL hr Minimum 103 mmHg 2 psig Moderate 258 mmHg 5 psig Maximum 465 mmHg 9 psig 3 min 50 sec 9 min 42 sec ...

Page 187: ...2 seconds Rate Occlusion Alarm Pressure Setting Typical Bolus Volume Maximum Bolus Volume 1 mL hr Minimum 103 mmHg 2 psig Moderate 258 mmHg 5 psig Maximum 465 mmHg 9 psig 0 1 mLs 0 1 mLs 0 2 mLs 0 1 mLs 0 2 mLs 0 3 mLs 25 mL hr Minimum 207 mmHg 4 psig Moderate 414 mmHg 8 psig Maximum 620 mmHg 12 psig 0 1 mLs 0 2 mLs 0 3 mLs 0 2 mLs 0 2 mLs 0 3 mLs At least 90 of the observed values 95 confidence w...

Page 188: ...t within the constraints and parameters of the device Use only accessory equipment complying with the device s safety requirements failure to do so may lead to reduced safety levels of the resulting system Consideration relating to accessory choice shall also include Use of the accessory in the patient vicinity evidence the safety certification of the accessory has been performed in accordance wit...

Page 189: ...age fluctuations flicker emissions IEC 61000 3 3 Not applicable Table 9 4 Guidance and Manufacturer s Declaration Electromagnetic Immunity The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance El...

Page 190: ...ve battery installed per Operator s Manual Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic characteristic of a typical location in a typical commercial or hospital environment 400 A m 1 The pump functions normally when exposed to power frequency magnetic fields of 400 A m Notes for Table 9 4 Note 1 The pump was tested to the requirements of IEC 60601 1 2 ...

Page 191: ...the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz TO 80 MHz outside ISM bandsa 10 Vrms 10 Vrms 150 kHz to 80 MHz in ISM bandsb 10 Vrms Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 5 GHz 10 V m 26 MHz to 1 0 GHz 20 V m 80 MHz to 2 5 GHz 10 V m 10 V m 3 20 V m 4 80 MHz to 800 MHz 800 MHz to 2 5 GHz 80 MHz to 800 MHz ...

Page 192: ...0 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for...

Page 193: ... 2 5 GHz 0 01 N A N A 0 06 0 12 0 1 N A N A 0 19 0 36 1 N A N A 0 6 1 2 10 N A N A 1 9 3 6 100 N A N A 6 12 Notes for Table 9 6 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W ...

Page 194: ...9 Electromagnetic Compatibility Statement 9 20 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 195: ...ing anything other than the recommended Baxter designated IV administration sets with this pump will result in operation that is not within the constraints and parameters of the device Baxter s warranty to repair or replace the product will be null and void if this product is used contrary to the directions for use contained in the labeling or if used with non recommended sets Baxter will assume n...

Page 196: ...enter In the event that your pump needs to be returned for service obtain a Return Authorization by calling 1 800 THE PUMP or your local service center Shipping costs for all pumps returned to Baxter shall be paid for by the customer The pump must be packed in its original container or in another Baxter approved container that will provide adequate protection during shipment To ensure prompt retur...

Page 197: ...uctions including all warnings and cautions prior to operating the COLLEAGUE CXE Volumetric Infusion Pump User Assistance Information North America For technical service of the COLLEAGUE pump call 1 800 THE PUMP For product usage information or clinical questions call Baxter Medication Delivery Product Information Center at 1 800 933 0303 Outside North America Visit www baxter com baxter_worldwide...

Page 198: ...ated for epidural use could result in serious injury to the patient Epidural administration of anesthetics is limited to short term infusion not to exceed 96 hours with indwelling catheters specifically indicated for short term anesthetic epidural drug delivery Epidural administration of analgesics is limited to use with indwelling catheters specifically indicated for either short term or long ter...

Page 199: ...eys are displayed Figure 11 1 The pump produces sound for as long as the Speaker Test soft key is pressed 3 Do one of the following If the tone is heard press Yes The pump completes self test and displays the Power On screen If the tone is not heard even after adjusting the volume control press No then press No again when prompted to confirm Do not use the pump If the continuous tone is not heard ...

Page 200: ... slide clamp at an appropriate location along the tube segment to ensure that there is adequate length of tubing between the patient and the pump to reduce tugging on the set Lastly ensure there is sufficient slack in the tubing between the distal end of the tubing channel and the patient to prevent tube tugging during activities such as moving the patient from one bed to another or transportation...

Page 201: ...lide it all the way into and along the tubing channel Figure 11 2c The pump pulls in the keyed slide clamp then loads the administration set into the pumping mechanism Figure 11 2d The pump module displays LOADING and then STOPPED Note A Tube Misloaded alarm will occur if the tubing is not loaded properly 5 Open the regulating clamp Verify that no solution is flowing 6 Attach the primed administra...

Page 202: ...me to be infused VTBI field 4 Enter the VTBI using the numeric keypad 5 Press the Confirm Primary soft key 6 Press START to start the infusion The green RUNNING LED will illuminate on the pump channel and a moving drop icon will appear on the Main Display Confirm that flow is occurring by observing drops falling into the drip chamber Note Pump Status If the pump status is unclear close any pop up ...

Page 203: ...and Page Down soft keys to highlight the appropriate label then press the Select soft key When the Select soft key is pressed the Programming screen is displayed showing the selected label Note Labels configured using the COLLEAGUE GUARDIAN feature do not appear in the label list To clear a label use the same procedure but select No Label from the label list No Label always appears first in the la...

Page 204: ...to be infused using the keypad 5 Highlight Time Duration using the Ø keys Use the keypad to enter the time period for the infusion in hours and minutes The pump automatically calculates the flow rate 6 Press the Confirm Primary soft key 7 Press the START key to start the infusion The green RUNNING LED will illuminate on the pump channel and a moving drop icon will appear on the Main Display Confir...

Page 205: ...sired label then press the Select soft key The programming mode changes to the mode configured for the selected label and the Rate field is filled with the configured value 4 Use the Ø key to highlight the The Volume To Be Infused field 5 Enter the volume using the numeric keypad 6 Press the Confirm Primary soft key If the values entered result in a dose that is outside the COLLEAGUE GUARDIAN rate...

Page 206: ...le channel pumps press the Primary soft key For triple channel pumps press the desired Channel Select key 2 Press the Colleague Guardian soft key The labels for which COLLEAGUE GUARDIAN limits have been defined are displayed in a pop up window Figure 11 8 3 Use the Ø keys to highlight the desired label then press the Select soft key The programming mode changes to the mode configured for the selec...

Page 207: ...e for data entry Fields not available for data entry appear as shaded For small patients weight can be entered in grams or ounces if appropriate To change weight units highlight the Weight field press the Units soft key to display the weight units list highlight the desired weight unit then press the Select soft key 5 Optional To view the limits for the label press the View Limits soft key The Lim...

Page 208: ...ow rate If values are changed so that the resulting drug amount diluent volume or concentration is non standard the changed values are indicated by white triangles beside them Figure 11 12 8 Press the Confirm Primary soft key If the dose entered is outside the dose limits a Limits Warning pop up is displayed Figure 11 13 Do one of the following Press Cancel Dose Ø key to cancel the dose then enter...

Page 209: ...ghlight indicating that the programmed dose is outside of the limits Programming a Dose Mode Infusion 1 For single channel pumps press the Primary soft key For triple channel pumps press the desired Channel Select key 2 Press the Change Mode soft key The Programming Modes Menu is displayed Use the Ø keys and or the Page Up and Page Down soft keys to highlight the appropriate dose mode then press t...

Page 210: ...ress the desired Channel Select key then press the Secondary soft key The Main Display shows the Secondary Rate Volume programming screen and the Rate field is highlighted 2 Enter the flow rate using the numeric keypad 3 Press the Vol key or use the Ø keys to highlight the Volume to be infused VTBI field 4 Enter the VTBI using the numeric keypad 5 Press the Confirm Secondary soft key 6 If the prim...

Page 211: ...ey The Volume Time Programming screen is displayed Figure 11 5 4 Enter the Volume to be infused using the keypad 5 Highlight Time Duration using the Ø keys Use the keypad to enter the time period for the infusion in hours and minutes The pump automatically calculates the flow rate 6 Press the Confirm Secondary soft key 7 Press the START key to start the infusion Confirm that flow is occurring by o...

Page 212: ...ect key for the channel to be put on Standby 2 Optional To preprogram the channel for future use program the infusion but do not press the START key 3 Press the Channel Select key again The Standby pop up is displayed 4 Press the key next to the YES shown on the pop up to place the channel into Standby mode To exit Standby 1 For single channel pumps press the Primary soft key For triple channel pu...

Page 213: ...ing the Manual Tube Release MTR Use Manual Tube Release only when the Tube Loading Mechanism is NOT functioning or if a channel failure occurs The MTR feature is for emergency use Never use the MTR to load or unload the administration set during normal operation Note The pump will not turn on if the MTR is in the open position For triple channel pumps If the MTR is used the remaining pump channels...

Page 214: ... This closes the keyed slide clamp and opens the pump mechanism so the administration set can be removed 6 Remove the administration set from the pump If the pump is on with no administration set in the tubing channel a Reset Manual Tube Release alarm occurs If the pump is on and the administration set is in the tubing channel when the MTR is activated a Close Regulating Clamp alarm occurs Close t...

Page 215: ...til it stops and push the tab into its socket For triple channel pumps Repeat the steps above as needed for additional channels 3 Press the Done soft key to clear the alarm Note If the MTR is used following a channel failure to remove the administration set the pump cannot be powered off until the MTR has been reset A Reset Manual Tube Release pop up message will be displayed Note If three unsucce...

Page 216: ...el open the regulating clamp and continue using the pump 5 Monitor the pump until replacement pump arrives and transfer any infusions to the replacement pump as soon as it is clinically safe Have the failed pump serviced as soon as possible Channel Failures 1 For single channel pumps press the Primary or Secondary soft key For triple channel pumps press the desired Channel Select key 2 For single ...

Page 217: ...wering on again Do this only once Proceed to step 8 For triple channel pumps allow any infusions running on the other pump channels to complete Remove the pump from service and have it inspected by Baxter trained qualified personnel as soon as possible Do not continue with this procedure 8 Based on the result do one of the following If the failure code recurs after the pump is turned back on stop ...

Page 218: ...ally restart if the occlusion is resolved within one minute after detec tion Auto Restart will be disabled if any key is pressed during a Downstream Occlusion alarm NO BATTERY Plug in Now Pump module display message current infusion information Cause The batteries are depleted and infusions have stopped The pump must be plugged into AC power before infusions may be restarted After 5 minutes in thi...

Page 219: ...re is being used to move an air bubble through the tubing Action The Advance Air alert is active when the Advance Air soft key is pressed This alert clears when the Done soft key is pressed Channel Stopped Pump module display message STOPPED Cause The pump is ON and the infusion is not running Action Complete the remaining programming steps and press the START key or power off the pump LOW Battery...

Page 220: ...11 Troubleshooting Alerts 11 24 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 221: ...temperature too low 8 15 troubleshooting 8 7 tube loading 8 15 tube misloaded 8 15 tube not loaded 8 15 unconfirmed primary program 8 15 unconfirmed secondary program 8 15 upstream occlusion 8 16 alarm silence key 2 4 alarms battery related 4 10 alert messages advance air 8 17 battery approaching end of life 8 17 changing primary program 8 17 changing secondary program 8 17 channel stopped 8 17 ch...

Page 222: ...rging the battery 7 3 check out 3 3 cleaning 7 1 approved cleaners 7 2 clear key 2 5 clearing volume history 4 59 clinician override 4 76 close regulating clamp alarm 8 13 COLLEAGUE communication cable 9 5 COLLEAGUE DL2 Event History Download Application 5 2 COLLEAGUE GUARDIAN Configuration Tool 5 2 COLLEAGUE GUARDIAN feature changed dose icon triangle 2 15 description 2 20 guidelines for using 2 ...

Page 223: ... volume to be infused 4 47 environmental operating limits 9 3 environmental storage specifications 9 4 epidural infusion warning 1 7 11 2 exiting standby 4 54 F failure channel 8 5 device 8 2 11 20 messages 8 2 troubleshooting 8 2 feature list 1 1 flow check description 2 13 display 4 77 icon 2 14 flow rate changing 4 60 4 65 during advance air 9 2 during priming 9 2 range specifications 9 2 fluid...

Page 224: ...ump channel abbreviations list of 6 7 label list screen 4 24 4 63 labeling information and locations 2 16 label part numbers 2 16 symbol definitions 1 4 labels adding after programming 4 63 application 6 9 selecting for display 4 23 leakage current 9 1 LEDs 2 7 library pump labels 2 19 limit override indication while running 4 29 4 32 4 36 limited battery alert 8 19 lithium battery low alert 8 19 ...

Page 225: ...reparing secondary infusions 4 46 preparing the infusion container 4 13 pressure maximum 9 12 preventive maintenance 7 2 primary infusion 4 21 primary out of range alarm 8 14 prime alert 8 20 priming 4 18 flow rate during 9 2 product features 1 1 programming dose based on patient weight 4 40 for future use 4 51 4 52 primary rate volume infusion 4 21 secondary infusion 4 45 secondary infusions 4 46...

Page 226: ...4 49 11 8 11 15 secondary 2 13 callback alert 4 50 icon 2 14 preparing administration set 4 46 programming 4 45 stopping 4 68 VTBI 4 47 secondary infusions 4 45 programming 4 46 4 49 secondary out of range alarm 8 14 selecting a label 4 23 4 63 self diagnostic testing 4 2 serial number 1 6 service information 10 2 setting up the pump 3 1 silence key 8 7 8 17 silencing alarm tones 8 7 soft key 2 10...

Page 227: ...dary callback alert 8 21 secondary out of range alarm 8 14 stuck key detected alarm 8 15 stuck key detected alert 8 21 temperature too high alarm 8 15 temperature too low alarm 8 15 tube loading alarm 8 15 tube misloaded alarm 8 15 tube not loaded alarm 8 15 unconfirmed primary program alarm 8 15 unconfirmed primary program alert 8 22 unconfirmed secondary program alarm 8 15 unconfirmed secondary ...

Page 228: ...Index 8 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP OPERATOR S MANUAL 071960491 ...

Page 229: ...071960491 ...

Page 230: ...ng a percentage of recycled fiber Baxter Healthcare SA 8010 Zurich Switzerland Baxter Healthcare Corporation Deerfield IL 60015 USA Copyright 1998 2010 Baxter Healthcare Corporation All rights reserved Original Release 07 2010 071960491 0123 ...

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