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Alaris Ivac 7130 Signature Gold Single Channel Infusion Pump Flow Sensor 4.54 - alaris_carefusion_7100_users

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1. 6 Enter VTBI Dose and press ENTER key AB OPTIONS ON Rate 250 0 mun 1 VTBI Dose EEES mL e No Doses en Frequency h el menu 5 4 7 Enter number of doses and press ENTER key Als OPTIONS ON Rate 250 0 min 4 VTBI Dose 100 0 mL e No Doses EE g Frequency h el menu 0 0 6 8 Enter dose frequency time interval from start of one dose AB OPTIONS until start of next and press ENTER key Oy OR O 1 VTBi Dose 100 0 mL of No Doses 4 A Frequency EE h el menu 5 4 9 Verify that all parameters are correct then press ok soft als OPTIONS ied ON Rate 250 0 mUh If Dose Complete Alert Option is enabled DOSE GO VTBI Dose 100 0 mL COMPLETE ALERT OPTION page appears of ice sn el menu OR 6 6 10 Press On or Off soft key as applicable ATB loprions OY bose COMPLETE e ALERT OPTION ef On GQ menu ok 5 4 User Manual Alaris SE Pump Rev2 X 35 Models 7100 7130 7200 7230 Programming Multi Dose Multi Dose Continued Program Continued 11 To continue programming press ok soft key All doses must be programmed to start within 24 hours e To start first dose immediately see Start First Dose Immediately e To delay start of first dose see Delay Start of First Dose Start First Do
2. 1 The channel does not need to be on hold to change the rate or VTBI values User Manual Alaris SE Pump Rev2 X 25 Models 7100 7130 7200 7230 Programming Secondary Infusion Secondary Infusion Continued Change Parameters During Infusion Continued 2 Press Primary Settings soft key _ al options e Primary rate Pri Rate primary volume to be infused Nye Rate 100 0 mL h Pri VTBI and total volume infused Total VI are O 1VTBI 50 0 mL displayed A canas e Display returns to normal secondary screen after six 1 Limitccotmm c seconds 1 6 T 3 Press aepiearie soft key to freeze display and highlight _ Gel OPTIONS value Rate 100 0 mL h Pri Rate 125 0 mL h Pri VTBI 950 0 mL Total VI 50 0 mL 4 Enter a new value and press ENTER key Clear Primary Volume Infused 1 Press Total VI soft key Current value is highlighted XF 2 To reset volume infused to 0 0 mL press CLEAR or 0 zero key 3 To accept new value press ENTER key Display returns to normal secondary screen after six seconds 1 If the flow sensor option is in use VTBI can be turned off by selecting VTBI pressing the CLEAR key and then pressing the ENTER key Or the primary VTBI can be deleted from the primary mode setup page see Configurable Options on page 92 2
3. 1 The illustrated pole clamp knob might not reflect the knob in use on the instrument User Manual Alaris SE Pump Rev2 X 67 Models 7100 7130 7200 7230 General Setup and Operation Start Up Start Up Continued Power On and Off Press POWER key e Instrument performs a self test e All indicators and displays momentarily light e An audio tone sounds e Hold indicator flashes e System startup page is briefly displayed 2 XX in example display represents current software revision ID No is instrument serial number AIB OPTIONS 3 NAS Model 7 XXX 1998 Alaris Medical SW Rev 2 XX ID No XXXXXXXXX 6 6 2 Press and hold POWER key until display turns off ae Audio Adjust This feature allows the audio volume to be adjusted for alarms alerts and KVO tone to either High Medium or Low if all audio volume levels are enabled in the hospital configuration settings Press 4n soft key next to lower LCD display e Audio volume level displays in lower LCD display Low dm Medium dim mM High dm m e Instrument can be configured to enable only Medium and High or High audio volume levels ZETA Each time the instrument is turned on verify and or set the monitoring mode resistance alert and or pressure alarm limit If the monitoring mode resistance alert and or pressure alarm limit are not verified the instr
4. 3 A B O Rate 25 0 mL h vVTBI 4 0 mL e Vl KK mL T v 174 TE 9 OPTIONS Rate 50 0 mL h VTBl 25 0 mL Totals Remaining VTBl 125 0 mL Time 1 h 30 min Adult ICU Lee 6 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Multi Step Multi Step Continued View Steps or Make Changes Continued View or Edit The channel must be on hold to view or edit the steps in the program 1 To place channel on hold press RUN HOLD key 2 To return to review page s press setup soft key aye OPTIONS e A tick mark I next to a step on review page indicates it o Rate 25 0 mL h has not started 1 VTBI 4 0 mL er Vi 1 0 mL e Only steps having a I can be edited of Completed steps or a step in progress do not have e eee al 4 e in progress step number is highlighted 3 To advance through review pages press ok soft key 4 To edit a parameter a Press soft key next to applicable step b Press soft key next to applicable parameter c Enter new value and press ENTER key d To accept changes press ok soft key 5 TO approve review page and STEP TOTALS page press ok soft key 6 Toresume infusion press run soft key or RUN HOLD key User Manual Alaris SE Pump Rev2 X 45 Models 7100 7130 7200 7230 Programming Multi Step Multi
5. Resistance has reached 100 Occlusion Upstream Flow is obstructed between fluid Check administration set for container and instrument s probable cause such as kinked pressure sensor tubing closed clamp Verify that blue thumb clamp on Flow Regulator has moved to open up position If not reload set Press run soft key to restart infusion Primary Flow Detected During Instrument detected flow from Verify that flow sensor is on Primary Secondary primary container during line and that setup is correct secondary infusion Alarm can occur only when using an optional flow sensor Set Out Set was removed during an Reinstall set Press run soft key to infusion restart infusion Setup Time Exceeded Instrument was turned on but no Press hold soft key to return to hold keys were pressed for ten mode minutes Instrument turns off if left in alarm more than five minutes If an audio alarm remains on turn instrument on and then off User Manual Alaris SE Pump Rev2 X 111 Models 7100 7130 7200 7230 Troubleshooting and Maintenance Alarms Alerts Prompts Battery Low Alarms Alerts Prompts Continued Meaning Battery has 30 minutes or less of charge remaining Response Plug power cord into an AC outlet as soon as possible Check Entry Key press unclear Press CLEAR key to continue Checking Line Flow is obstructed Auto Restart Plus feature is on Auto Restart P
6. Adjustable Pressure Alarm to provide an early warning of increases in downstream pressure Trend Graph to display downstream pressure or flow resistance over time Pressure Baseline to provide a starting point from which to measure changes in system pressure AZ M The Alaris SE pump is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected ltis a positive displacement delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice including resistances to flow imposed by small gauge catheters filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions Before each use verify that the pressure or resistance alarm limits are appropriate for the patient Each time the instrument is turned on verify and or set the monitoring mode and resistance alert and or pressure alarm limit If the monitoring mode and resistance alert and or pressure alarm limit are not verified the instrument might not be operating with the desired occlusion detection parameter s User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 49 Dynamic Monitoring System Monitoring Options General Monitoring Options General IV lines catheters and app
7. Hi lt 0 04 0 02 0 00 0 02 o a a ee 20 20 0 20 40 60 80 100 120 Time min Time min Pressure Mode Trumpet Curve at 0 1 mL h initial Pressure Mode Trumpet Curve at 1 mL h initial Flow Rate Error 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min Pressure Mode Trumpet Curve at 0 1 mL h 48 hr Pressure Mode Trumpet Curve at 1 mL h 48 hr Flow Rate Error Flow Rate Error 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min 102 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves Continued Pressure Mode Continued Pressure Mode Start up at 25 mL h initial Pressure Mode Start up at 999 9 mL h initial 50 2000 45 1800 40 1600 35 1400 30 1200 g 20 1000 E 20 E 800 15 600 10 400 5 200 0 0 5 200 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Time min Time min Pressure Mode Trumpet Curve at 25 mL h initial Pressure Mode Trumpet Curve at 999 9 mL h initial 15 15 o o al al Flow Rate Error o Flow Rate Error o 5 5 10 10 15 15 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min Pressure Mode Trumpet Curve at 25 mL h 48 hr Pressure Mode Trumpet Curve at 999 9 mL h 24 hr Flow Rate Error Flow Rate Error 0 5 10
8. e Dual channel instrument o Pressing split screen key A 6 o Replaced with a split screen display after one minute if both channels are infusing Upstream Occlusions Detection If the flow pathway between the fluid container and the Pressure Sensor is obstructed due to kinked tubing a closed clamp or an improperly installed set an OCCLUSION UPSTREAM condition exists Depending on where the upstream path is occluded flow might continue for a fraction of a mL before the OCCLUSION UPSTREAM alarm is produced At high infusion rates the instrument takes relatively little time to alarm At low infusion rates a longer time elapses before the instrument detects the condition and alarms In either case some flow continues from the instrument during the time prior to the alarm due to the elastic behavior of the tubing between the occlusion site and the pumping mechanism If an OCCLUSION UPSTREAM alarm occurs investigate and remedy the cause before resuming the infusion Ensure that the upstream flow path such as tubing is free of obstructions that any clamp is open and that the blue thumb clamp on the AccuSlide flow regulator is in the open up position 64 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Upstream Occlusions Detection Upstream Occlusions Detection Continued VVhen an upstream occlusion condition is detected e OCCLUSION UPSTREAM me
9. Silence Rey Silences audible alarm or alert for two minutes message remains on screen New alarm or alert reinstates audible tone CLEAR Key Clears selected numeric value gt i x E N NS S Audio Volume Key Sets audio volume for alarms alerts and KVO tone Numeric Keypad Enters and changes values 82 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Features and Displays Features and Displays Continued Operating Features Controls Indicators Continued Panel Lock Key RS 232 Connector Cover Flow Sensor Receptacle s RS 232 Connector Pole Clamp Rotation Lever Flow Control Actuator Pumping Mechanism Clamp Arms Loading Guide Pressure Transducer Air in Line Detector Air in Line Arm User Manual Alaris SE Pump Rev2 X 83 Models 7100 7130 7200 7230 General Information Features and Displays Features and Displays Continued Displays and Soft Keys Main Display The Main Display is backlit for easy viewing The backlight dims when operating on battery power as an energy saving feature Pressing any key automatically turns the backlight up again Rate Display The LED rate display is easily viewed from a distance lt indicates the current infusion rate s in mL h and flashes to indicate a hold or alarm condition Single channel display The
10. 5 4 4 If desired enter minutes 0 59 and press ENTER key acl OPTIONS Volumetric rate is automatically calculated and displayed O STEP 1 C Rate mL h ayi VTBI 5 0 mL o Time 0h HZ min 6 6 6 5 To approve all displayed information and advance to STEP 2 of infusion sequence press ok soft key 6 To set up each additional step of infusion sequence repeat steps 1 through 5 7 When all steps have been entered and accepted press done soft key Review page displays three sequence steps at a time User Manual Alaris SE Pump Rev2 X 43 Models 7100 7130 7200 7230 Programming Multi Step Multi Step Continued Program Continued Program Volume and Time Continued 8 To approve and advance through review pages press ok soft key 9 To clear VI if desired press CLEAR or 0 zero key and then press ENTER key 10 To approve STEP TOTALS page press ok soft key 11 To start multi step infusion press run soft key or RUN HOLD key View Steps or Make Changes Select the desired channel as necessary Clear Volume Infused The channel does not need to be on hold to clear the VI 1 Press VI soft key 2 Press CLEAR or 0 zero key 3 Press ENTER key View Totals Remaining The channel does not need to be on hold to view the totals remaining Press M soft key Remaining time and VTBI are displayed for a short interval OPTIONS
11. Rev2 X Models 7100 7130 7200 7230 User Manual Alaris SE Pump Rev2 X Models7100 7130 7200 7230
12. When the secondary VTBI reaches zero an audio tone sounds medication additions if enabled Secondary Complete message is briefly Underestimating the volume causes displayed and the primary infusion rate automatically resumes the remaining secondary solution to Delivery from the primary container also resumes when the be infused at the primary rate fluid level in the secondary line is level with the fluid in the overestimating results in the primary primary container solution being infused at the secondary rate Multiple doses from For information regarding flow sensor use with secondary a single container are not possible infusions see Flow Sensor on page 79 The clamp on the secondary administration set must be opened If the clamp is not opened the fluid is delivered from the primary container e The secondary administration set must be primed prior to beginning the secondary infusion e Verify that the secondary systems are properly set up to ensure that there is a proper flow 22 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Secondary Infusion Secondary Infusion Continued 1 Open secondary administration set package remove set and close clamp 2 Insert administration set spike into prepared fluid contain
13. fully charged battery e ambient room temperature 73 7 F 23 4 C e resistance monitoring modes e rate 100 mL h on a single channel instrument and 50 mL h on each channel of a dual channel instrument Battery run time is affected by operating mode rate monitoring options and back pressure see Battery Management System on page 77 Case Impact and flame resistant plastic Critical Volume Maximum incremental volume in case of single point failure does not exceed 1 0 mL at 999 9 mL h Dimensions nominal 7100 7130 7200 7230 Depth 5 0 in 12 7 cm 5 0 in 12 7 cm Height 8 6 in 21 8 cm 8 6 in 21 8 cm Power cord 10 ft 3 m 10 ft 3 m Weight 6 6 Ib 3 0 kg 8 4 Ib 3 8 kg Width 7 6 in 19 3 cm 10 7 in 26 7 cm Without pole clamp Without power cord 94 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Specifications Specifications Continued Time to Occlusion and Bolus Volume data tested to standards defined in AAMI ID26 1998 Section 51 101 b Downstream Occlusion Time to Alarm Bolus Volume Time to Detect Monitoring Options rok be EN Pressure Resistance and High minutes Resistance E 25 mmHg 600 mmHg 100 100 Threshold Settings 25 mmHg 600 mmHg Maximum 2 5 2 7 1 mL h Typical 0 6 30 0 6 4 Maximum 1 25 1 3 25 mL h Typical 0 1 1 0 1 1 When occlusion alarm pressure limit is set to maximum threshold setting max
14. 115 Troubleshooting and Maintenance Inspection Requirements Inspection Requirements To ensure that the system remains in good operating condition both regular and preventive maintenance inspections are required Refer to the applicable Alaris SE pump service manual for detailed inspection instructions REGULAR INSPECTIONS Procedure Frequency Inspect for Damage e Case e e Connector e e Keypad Each usage Each usage Each usage Cleaning As required Start Up Each usage WARNING Failure to perform these inspections can result in improper instrument operation CAUTION e Preventive maintenance inspections should only be performed by qualified service personnel e Inspect LCD for anomalies improperly lit unlit pixels Inspect and clean the Alaris SE pump as needed typically between patient uses DO NOT use e Solutions containing phosphoric acid Foamy Q amp A aromatic solvents such as naphtha or paint thinner chlorinated solvents such as Trichloroethane MEK Toluene ammonia acetone benzene xylene or alcohol other than as specified below e Hard or pointed objects to clean any part of instrument e Pressurized sprays on instrument Acceptable cleaning solutions are as follows use per manufacturers instructions 10 bleach solution one part bleach to nine parts water Vesphene Manu Klenz and warm water 1 Unplug power cord from AC outlet
15. Allows clinician to enter the flow rate or the drug dose rate for a continuous infusion The system then calculates the alternate parameter based on the drug concentration and if used the weight Loading Dose Allows the clinician to set up an initial infusion rate for a specific volume to be followed automatically by a maintenance rate primary settings from the same container This is useful for delivering fluid challenges Multi Dose Allows 1 to 24 doses to be programmed at equally spaced intervals on the same instrument over a 24 hour period This mode allows delivery of multiple equal doses from the same IV container at regularly scheduled intervals Within this mode a delayed start option allows the instrument to be programmed to delay the infusion start for up to 8 hours Multi Dose Alert When enabled this feature alerts the clinician of the completion of each dose delivered during a Multi Dose program Multi Step Allows a sequential drug delivery program up to nine steps to be set delivering volumes of fluid at different rates at each step This allows the instrument parameters to be set up once and deliver a step profile eliminating the need to change the rate and VTBI after each step of the infusion The infusion may be programmed in rate volume or volume time Rate Maximum Maximum infusion rate may be set from 0 1 mL h to 999 9 mL h in 0 1 mL h increments User Manual Alaris SE Pump Rev2 X 91 Models 7100 7130 720
16. Models 7100 7130 7200 7230 Programming Multi Dose Multi Dose Continued Resume an Interrupted Multi Dose Continued 3 To access setup parameters press Review Resume soft key e If infusion was in progress when interrupted see Infusion in Progress When Interrupted e If infusion was not in progress when interrupted see Infusion Not in Progress When Interrupted Infusion in Progress When Interrupted 1 To approve and advance to main hold page press ok soft key 2 To resume infusion press RUN HOLD key or run soft key Infusion Not in Progress When Interrupted Press ok soft key N Edit time to delivery of next dose as necessary Pa To begin timer s countdown to delivery of next dose press start timer soft key When final dose is complete e Dose of Complete displays until user takes action e No Continuous Infusion or KVO Rate occurs _ 13 OPTIONS 4 Review Resume Enter New Program el Quit Program el Y ULTLDOSE MENU ALT menu DOSE 1 of 4 0 6 6 AlB OPTIONS ON Rate 250 0 mun _ vTBI Dose 100 0 mL o Frequency 6h 2 DOSE 1 INCOMPLETE es menu OR 5 4 OO OATBI OPTIONS Rate 250 0 mL h VTBI 80 0 mL VI 20 0 mL run o User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 39 Programming Multi
17. Rev2 X 87 Models 7100 7130 7200 7230 General Information Configurable Settings Configurable Settings Continued Definitions Continued Dynamic Monitoring Auto Restart Plus Part of the Dynamic Monitoring system and designed to help minimize nuisance occlusion downstream alarms lt allows the instrument to automatically continue an infusion following the detection of a downstream occlusion if downstream pressure falls to an acceptable level within a 40 second Checking Line period lt may be set to off 0 restarts or to allow from 1 to 9 Checking Line restarts If the allowable number of restarts is exceeded or when resistance or pressure conditions indicate an occlusion an occlusion downstream alarm occurs Monitoring Options Dynamic monitoring allows one of the following monitoring modes to be selected Resistance mode High Resistance mode or Pressure mode All of these modes offer an optional Auto Restart Plus feature and optional trend graph display Trends Provides ability to display downstream pressure or flow resistance over time Trend graphs of 15 minutes 1 hour 4 hours and 12 hours are available during normal operation When Trends is enabled and the instrument is operating in pressure mode a pressure trend graph is available When Trends is enabled and the instrument is operating in resistance mode a resistance trend graph is available 88 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7
18. adjustable pressure modes the Alaris SE pump provides enhanced flow continuity at rates below 50 mL h 50 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options General Monitoring Options General Continued Select Monitoring Option Continued 4 Press soft key for applicable option Tam loprions 5 Press ok soft key 2 Sa e If Adjustable Pressure option is selected pressure aji High Resistance system accuracy may be enhanced by ensuring that no el occlusion or other pressure source exists in IV line els when activating RUN HOLD ry e If Resistance option is selected Resistance is ale arros displayed below bar graph while infusing ae ee VI 0 0 mL Ga VTBI 1000 0 mL 50 Resistance o 6 e If High Resistance option is selected Hi Resist is AJB oerions displayed below bar graph while infusing Rate 125 0 mL h VTBI 1000 0 mL a VI 0 0 mL o r Ba y Hi Sop o 6 6 1 If pressure limit adjustment is available selection reads Adjustable Pressure otherwise it reads Pressure 2 While the channel is on the selected option resistance alert and pressure alarm thresholds remain in effect until changed 3 Pressure alarm limits may be adjusted when operating in Adjustable Pressure
19. after starting an infusion Set Alert Marker To numerically display present alert level marker press 4 or P Taje OPTIONS soft key Vertical line on resistance bar graph visually indicates ON Rate er El the alert level Ga VTBI 1000 0 mL 7 nh 0 0 mL Each additional press of an arrow soft key increases or eka decreases the alert level marker and numeric value by 5 La 3 Alert 70 r 6 o Resistance Alert Message If flow resistance exceeds the alert level marker a Resistance AE oFrions Alert message is displayed and an alert tone sounds The O Rae 125 0 mL h channel continues to infuse and the message and tone Ga VTBI 1000 0 mL continue until one of the follovving resistance levels occurs a VI 0 0 mL e IV line site resistance falls below alert level marker s Resistance Alert e Resistance alert level marker increases above current ry measured resistance value Resistance rises to 100 initiating a Checking Line or OCCLUSION DOWNSTREAM condition 94 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Resistance Mode Monitoring Options Resistance Mode Continued Resistance Trend Graphs In Resistance and High Resistance monitoring modes a trend graph displays flow resistance over time Trend graphs of 15 minutes 1 hour 4 hours and 12
20. be of interest when certain drugs are being administered Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug being infused and on the degree of intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered The start up curves represent continuous flow rate versus operating time for two hours from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Tests were conducted in accordance with IEC 60601 2 24 Particular requirements for safety of infusion pumps and controllers and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers using a Model 72003 Administration Set includes Flow Regulator 100 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves Continued Flovv Characteristics Under Varying Delivery Conditions Effects of pressure variations Under conditions of 100 mmHg pressure the Alaris SE pump typically exhibits a long term accuracy offset of approximately 1 4 from mean values Under conditions of 300 mmHg pr
21. been tested and certified in accordance with applicable United States and Canadian electrical safety and performance standards CSA C22 2 No 125 O 6 T YY Es e Single Use Do not re use DEHP in fluid pathvvay No DEHP in fluid pathvvay Product contains latex Product is latex free Drops per milliliter specification for product is identified on drop symbol Product incorporates SmartSite needle free valve ports and should not be accessed by a needle 90 OD EO amp XX ml Approximate set priming volume 98 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Symbols and Terms Symbols and Terms Continued Expiration date for product is identified near hour glass symbol Do not use if package is damaged A rad Electrostatic discharge ESD K Radio frequency RF transmission a Depending on manufacturing and distribution timing the Alaris SE pump might bear either the CF or CF Defibrillator Proof symbol on the main rating label The Alaris SE pump has been tested and complies with IEC 60601 1 Amendment 2 Clause 17 h for Defibrillator Proof Equipment cm centimeter min minute gm gram g mL milliliter h hour mmol millimole HLD infusion in hold mode mUn milliunit In inch nan nanogram ng kg kilogram OPT optional mode KVO keep vein open infusion rate mode PRI primary infusion mode Ib pound SEC secondary infus
22. entered Silence Key Silences audible alarm or alert for two minutes message remains on screen New alarm or alert reinstates audible tone CLEAR Key Clears selected numeric value Audio Volume Key Sets audio volume for alarms alerts and KVO tone Numeric Keypad Enters and changes values User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 81 General Information Features and Displays Features and Displays Continued Operating Features Controls Indicators Continued Dual Channel Model Infusing Indicators Power Keys Turn Indicate instrument is instrument on and off infusing a Power Indicator Alarm Indicators Indicate Green Plugged in and instrument is in alarm and charging has stopped infusing Flashing Amber Battery power Channel Select Keys lee Indicators Select channel o A or B Is lit when channel a S a is selected na Fe RUN HOLD Reys Start and stop infusion To restart channel must be selected o A RUN HOLD OPTIONS Key Accesses OPTIONS ser additional features Secondary SEC Rey Selects secondary mode Split Screen Rey Displays information for both channels when both channels are infusing Primary PRI Rey Selects primary mode Channel must be selected ENTER Rey Accepts value or selection entered Soft Keys See Displays and Soft Reys on page 84
23. hours are available during normal operation when enabled through the hospital configuration settings Downstream Occlusions are indicated by a tick mark I at the top of the trend screen View Graph 1 Select applicable channel as necessary Trend graph is not available when the split screen is displayed 2 Press OPTIONS key el 12h RESISTANCE now Y return clear time 3 Press Resistance Trend soft key t3 ry 4 To change graph time frame press time soft key e A dashed horizontal line represents current resistance alert level e Gaps in graph might indicate noninfusing conditions such as turned off on hold in alarm e If channel has been placed in Pressure Monitoring mode for some portion of a trend graph window resistance data is not available and zero values are plotted e Atick mark I at top of graph indicates an occlusion e When viewing Resistance Trend Graphs in High AE OPTIONS Resistance mode HI RESIST is displayed under graph Or i e el 12h HI RESIST now Y return clear time ee User Manual Alaris SE Pump Rev2 X 55 Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Resistance Mode Monitoring Options Resistance Mode Continued Resistance Trend Graphs Continued Clear Graph 1 To clear graphed data press clear soft key 2 P
24. its proper function prior to reuse e If an instrument appears damaged contact CareFusion for authorization to return it for repair e Hyperbaric Chamber Operation o The Alaris SE pump is not certified for use in oxygen enriched environments o The healthcare facility s hyperbaric safety director is responsible for all equipment used in the hyperbaric chamber environment User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information VVarnings and Cautions Warnings and Cautions Continued Administration Sets e When priming o Ensure that patient is not connected o Ensure that air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient e Discard if packaging is not intact or protector caps are unattached e Use only sets dedicated for use with the Alaris SE pump The use of any other set might cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard CAUTION Before operating the instrument verify that the administration set is free from kinks and installed correctly in the instrument Epidural Administration e Epidural administration of drugs other than those indicated for epidural use might result in serious inj
25. keypress tone 1 p Y LA Inactive soft keys Entering Programming Values To enter or change a programming value select the applicable parameter by pressing the corresponding soft key Selecting a parameter highlights the field or existing value To enter a value use the numeric keys If the highlight is flashing the entry is incomplete When the entry is complete press the ENTER key To clear an existing value press the CLEAR key To restore the value press the CLEAR key a second time before pressing the ENTER key When the entry is complete press the ENTER key When all parameters required on a programming setup screen have been programmed press the ok soft key to confirm all entries and continue programming 86 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Configurable Settings Configurable Settings The configurable options are set in the configuration mode by qualified service personnel If the configuration settings need to be changed from the factory default settings refer to the Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information Air in Line Air in Line Threshold microliters Sets the upper limit for a single bolus of air to pass without an alarm In other words it is the amount of air allowed to pass through the air
26. mode using the soft keys located below the arrow symbols see Adjustable Pressure Alarm on page 58 4 Maximum pressure limit settings may be configured by qualified service personnel 5 Resistance alert limit may be adjusted using the soft keys located below the arrow symbols see Resistance Alert on page 54 6 High Resistance alert limit may be adjusted using the soft keys located below the arrow symbols User Manual Alaris SE Pump Rev2 X 51 Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Resistance Mode Monitoring Options Resistance Mode Detection of Downstream Occlusions In the Resistance or High Resistance monitoring mode a RESISTANCE ALERT condition occurs when the measured resistance reaches the alert limit An OCCLUSION DOWNSTREAM condition is detected when one of the following conditions occurs e The measured resistance reaches 100 of scale For the Resistance mode 100 results from a resistance producing 2 mmHg per mL h of flow For the High Resistance mode 100 results from a resistance producing 6 mmHg per mL h flow e The configured pressure limit is exceeded This limit may be set by qualified service personnel from 1 mmHg to 600 mmHg Pressure Limit Maximum When a Downstream Occlusion is detected one of the following responses occurs e If Auto Restart Plus feature is on Checking Line message is displayed and audible tone sounds e f Auto Rest
27. name is listed proceed to Drug Name Listed e If desired drug is not listed proceed to Drug Name Not Listed on page 30 Drug Name Listed 1 Press soft key next to a drug name to select it 1 To approve all displayed information and advance to first setup page perform one of the following steps e To make changes go to next step To change concentration height or weight units press 2 e Press ok soft key 3 soft key next to a unit to select it FaN soft key appears 1 Dose units cannot be changed 2 The vveight and height unit selections are displayed only if they are appropriate for the selected drug A B OPTIONS ON Dobutamine Qi Dopamine Mi Esmolol 01 heparin el menu page gt 5 4 A B OPTIONS o Dose in mcg kg min El 1 Conc in mg mL B el Weight in kg el menu ok 0 ee User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 29 Programming Drug Specific Dose Rate Calculator DRC Drug Specific Dose Rate Calculator DRC Continued Program Continued Drug Name Listed Continued 4 To scroll through available units press and release FA OO RB options soft key When correct unit is displayed press ENTER key Oy Dose in mcg kg min Concentration mcg mg gm Un mUn mEq Conc infgEjmL Weight kg Ib eft W
28. of a Power Line Surge mode mode typical commercial or hospital environment 2 kV common 2 kV common mode mode IEC 61000 4 8 3 A m 400 A m 50 Hz a Power frequency magnetic fields should be Power Frequency 400 Alm 60 Hz 2 at levels characteristic of a typical location Magnetic Field 50 in a typical commercial or hospital 60 Hz environment a Compliance levels raised by IEC 60601 2 24 b Performed at the minimum and maximum rated input voltage User Manual Alaris SE Pump Rev2 X 121 Models 7100 7130 7200 7230 Regulations and Standards Compliance Compliance Continued Electromagnetic Environment Continued Emissions Test IEC 61000 4 11 Voltage Dips Short Interruptions and Voltage Variations IEC 60601 1 2 Test Level lt 5 UT 29590 dip in UT for 0 5 cycle Table 2 Continued Electromagnetic Immunity Compliance Level 8 lt 5 UT 29590 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 seconds a Ut is the AC mains voltage prior to application of the test level b Performed at the minimum and maximum rated input voltage lt 5 UT gt 95 dip in UT for 5 seconds Electromagnetic Environment Guidance Mains power quality should be that of a typical com
29. ok soft key 7 To continue or restart program press run soft key or RUN HOLD key Quit Multi Step The channel must be on hold or the last dose complete Press menu soft key 2 To return to primary setup page press Quit Program soft key Primary setup page parameters might be different than those for the Multi Step program Verify all settings prior to resuming an infusion User Manual Alaris SE Pump Rev2 X 47 Models 7100 7130 7200 7230 Programming Multi Step THIS PAGE INTENTIONALLY LEFT BLANK 48 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System All features and options in this section are shovvn as enabled Options are enabled through the instrument configuration settings The Dynamic Monitoring System provides the ability to monitor downstream pressure or resistance allowing rapid detection of full and partial occlusions Resistance monitoring eliminates the impact of patient elevation and flow rate to provide the most direct assessment of patency Components of this system are Monitoring Options to select IV line site monitoring modes of resistance high resistance and adjustable or fixed pressure Auto Restart Plus Feature allows instrument to automatically resume operation when specific instrument operating conditions are met Adjustable Resistance Alert to provide an early warning of increases in downstream flow resistance
30. press run soft key or RUN HOLD key to start infusion 9 To briefly view current setup parameters from RUN HOLD page or during a running infusion press EH soft key Loading Dose This is an optional feature that is configured by the facility Options are enabled through the instrument configuration settings This feature allows an initial infusion rate to be set up for a WARNING specific volume automatically followed by a maintenance rate This mode is useful for delivering primary settings from the same container The primary VTBI fluid challenges This feature is for and VI include the loading dose volumes When the loading delivery from primary containers dose VTBI reaches zero a transition tone sounds if transition only Using this feature with two tone feature is enabled Load Dose Complete message is separate containers might result in et displayed and the primary settings automatically take inintended lowrstes effect Verify that the primary mode parameters are correct prior to accessing the Loading Dose option 1 Select desired channel as necessary Channel must be on hold in primary mode 2 Press OPTIONS key 32 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Loading Dose Program Continued Press Loading Dose soft key P a O N 0 Loading Dose Continued To program rate perform one of following steps e If current rate is appropriate press
31. sources e bag or vented bottle vent closed on administration set e drip chamber unvented bottle with vent open on administration set 17 Adjust fluid level in burette until meniscus is level with zero mark on burette 1 The factory default for the Monitoring Options mode is Pressure 2 A 30 inch head height was used in the initial qualification of this process and is the recommended head height for the Check In Rate Accuracy Test Based on observed field use a 24 inch head height was also tested and verified for the Rate Accuracy Specification 3 The instrument might need to be run to prime the line to the zero level of the burette step 14 6 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Rate Accuracy Qualification Test Continued 18 Verify that primary infusion rate is 400 mL h 19 Reset VTBI to 40 mL and clear volume infused 20 Press RUN HOLD key to start primary infusion 21 Instrument will run approximately 360 seconds six minutes to complete delivery and then go into RVO mode Stop instrument within one second of its entering RVO mode 22 Make a note of volume collected in burette 23 Note expected volume as identified on 80VCS set insert 24 Do not remove 80VCS set from instrument until one of following conclusions is determined e Instrument passes rate verification and calibrat
32. starting an infusion Resistance Display When enabled provides a bar graph on the Main Display to indicate the current resistance on a scale of 0 to 100 When disabled the resistance alert feature is unavailable Resistance Pressure Setting Provides an Occlusion Downstream alarm when the measured pressure reaches the Resistance Pressure limit while operating in Resistance Mode This threshold may be set from 1 mmHg to 600 mmHg in 1 mmHg increments In other words while operating in Resistance mode or High Resistance mode an Occlusion Downstream condition can be detected in two ways measured resistance reaches 100 of scale or configured Resistance Pressure Setting is exceeded KVO Rate KVO keep vein open mode automatically occurs when the primary VTBI has counted down to 0 0 mL The channel switches to the preset KVO rate or remains at the current rate whichever is less The KVO rate may be set from 0 1 mL h to 20 mL h in 0 1 mL h increments and cannot be adjusted by the clinician 90 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Configurable Settings Configurable Settings Continued Definitions Continued Optional Modes Optional modes include Loading Dose Dose Rate Calculator Multi Step and Multi Dose Each of these can be enabled or disabled When disabled they will not appear on the Options menu and cannot be accessed by the clinician Dose Rate Calculator
33. status bar indicates which mode the instrument is in Optional Modes Primary Hold Secondary or KVO Dual channel display The status bar indicates which mode the instrument is in KVO Optional Modes Hold Primary or Secondary Split Screen Dual Channel Only When both channels are infusing a split screen showing programmed information for both channels is displayed automatically after one minute Press alB key to switch immediately to split screen Press or key to stop split screen CAUTION Appearance of lines and or dots that remain on constantly when the instrument is powered on might indicate improper functioning of the Main Display Although the instrument is functioning properly return it to qualified service personnel A B OPTIONS o ER Rate 125 0 Rate 130 5 VTBI VTBI User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Features and Displays Features and Displays Continued Displays and Soft Keys Continued Lower Display The lower LCD display is backlit for easy viewing The display dims when operating on battery power as an energy saving feature Panel Lock Indicator Displayed if panel lock is on Audio Volume Indicator Indicates audio volume for alarms and alerts NJ gy 2 DY o Computer Mode Indicator AAIR Displayed if instrument is in computer monitor
34. system pressure value e The pressure measurement can be optimized particularly at low flow rates less than 3 mL h by pausing and restarting at least once every two hours for example when reprogramming VTBI This allows the pressure baseline to calibrate based on current system pressure e Prior to activation ensure that pressure has not built up in the IV line due to an occlusion or flow from other instruments through a common catheter This results in a more accurate pressure measurement e When loading a set connected to a small diameter catheter wait at least five seconds after loading the set before activating RUN HOLD This allows pressure generated by the loading process to dissipate and the sensor to stabilize Very small PICC catheters such as 28 gauge 1 2 French might require 60 seconds or more for stabilization e When multiple instruments are infusing through a common small diameter catheter pressure measurement accuracy can be optimized by temporarily stopping all infusions and then restarting all instruments beginning with the instrument delivering at the lowest rate User Manual Alaris SE Pump Rev2 X 59 Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Options Pressure Mode Continued Pressure Baseline The Pressure Baseline feature when enabled through the hospital configuration settings provides a real time bar graph and numeric disp
35. the the instrument RS 232 connector must remain in place when the connector is not To ensure continued electromagnetic compatibility in use performance the communications cable attached to the instrument should be no longer than 3 feet 3 inches or 1 meter have fully shielded connector housings and have a 100 coverage braid foil shield attached to the connector housings around the signal conductors with the cable jacket Connect to a Computer Press OPTIONS key e Only equipment that complies with IEC EN 60601 1 or UL 1069 approved medical or hospital signaling equipment is to be connected to the RS 232 connector To advance to next page press page soft Rey Press Computer Link soft key Press Monitor soft key oY a ee da Press ok soft key User Manual Alaris SE Pump Rev2 X 71 Models 7100 7130 7200 7230 General Setup and Operation RS 2323 Computer Link RS 2323 Computer Link Continued Connect to a Computer Continued 6 Connect an RS 232 cable from hospital computer to RS 232 port on instrument s rear panel e During communication between host computer and instrument MNTR Monitor Mode appears in lower LCD MNTR remains in lower display when mode is GOLD selected and communication with computer is IL established e If communication is interrupted MNTR flashes for 60 seconds Disconnect from a Computer Press OPTIONS key To advance
36. to reduce or eliminate interference CISPR 11 Group 1 The Alaris SE pump is suitable for use in all establishments RF Emissions Class B including domestic establishments and those directly connected to a public low voltage power supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Class A Harmonic Emissions IEC 61000 3 2 Complies Voltage Fluctuations Flicker Emissions 120 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Regulations and Standards Compliance Compliance Continued Electromagnetic Environment Continued Table 2 Electromagnetic Immunity missions Test IEC 60601 1 2 Compliance Electromagnetic Environment Test Level Level Guidance IEC 61000 4 2 6 kV contact 8 kV contact 2 Floors should be wood concrete or EL 8 RV air 15 RV air ele Discharge ESD 7 If the floors are covered with synthetic material relative humidity should be at least 30 If a connector testing exemption is used the following ESD sensitivity symbol appears adjacent to each connector Do Not Touch A Ales IEC 61000 4 4 2 kV for power 2 kV for power Mains power quality should be that of a Electrical Fast supply lines supply lines typical commercial or hospital environment ae Burst 1 kV for input 1 kV for input EFT output lines output lines IEC 61000 4 5 1 RV differential 1 RV differential Mains power quality should be that
37. when instrument is operating on battery power e Automatic battery power if instrument is unplugged or in the event of a power failure e Low battery alert indicates battery depletion is imminent beginning at least 30 minutes prior to a BATTERY DEPLETED alarm Maximum battery capacity as well as optimal gauge accuracy is reached after several complete charge discharge recharge cycles in the refresh process It is recommended that the battery be fully charged discharged recharged using the refresh cycle before placing the instrument in use Refer to the Technical Service Manual for detailed information on the refresh cycle User Manual Alaris SE Pump Rev2 X 17 Models 7100 7130 7200 7230 General Information Battery Management System Battery Management System Continued Battery Power Gauge and Indicator The gauge indicates approximate battery run time remaining under current operating conditions It is located in the lower du 2 display and is always on To ensure a more accurate battery GOLD gauge reading review the remaining battery run time EL LLULL approximately five minutes after starting an infusion Battery run time might be affected by the operating mode rate monitoring options and back pressure The gauge accuracy is based on the last refresh cycle and is affected by the number of charge discharge recharge cycles The instrument label and battery gauge are alwa
38. ww y EEN F 0 6 6 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 33 Programming Multi Dose This feature allovvs 1 to 24 infusions to be preprogrammed vvith the same rate and volume to be delivered at equally spaced intervals over a period of up to 24 hours It also offers a delayed start option for up to 8 hours and a Dose Complete Alert Option These features can be turned on or off Programming a multi dose infusion requires another infusing line to keep the vein open between programmed doses because there is no KVO infusion between doses or following program completion Select desired channel as necessary Channel must be on hold in primary mode h 2 Press OPTIONS key 3 Press Multi Dose soft key A B OPTIONS GN Multi Step 1 Multi Dose el Loading Dose E View Curr Settings el return 4 page 4 Press Enter New Program soft key Tala OPTIONS A MULTI DOSE MENU 1 ReviewResume e Enter Nevv Program el Quit Program 5 Enter infusion rate and press ENTER key ABB OPTIONS o Ratera mL h 1 VTBi Dose mL eo No Doses g Frequency h el menu dd 4 34 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Multi Dose Multi Dose Continued Program Continued
39. 0 7230 General Information Configurable Settings Configurable Settings Continued Configurable Options The follovving features can be customized by qualified service personnel in the Configuration or Diagnostic Modes Feature Air in Line Air in Line Accumulator Air in Line Threshold Air in Line Reset Audio Transition Tone Volumes Computer Link Baud Rate Mode Parity Configuration Name Options On Off 50 100 200 or 500 mcL On Off On Off Low Med Hi Med Hi or Hi 300 600 1200 1800 2400 4800 9600 Monitor Off Off Even Odd None four alphanumeric characters Default On Low Med Hi GOLD Instrument ID nine digits 000000000 KVO Rate 0 1 to 20 mL h 5 0 mL h Language Language English English Monitoring Options Auto Restart Plus Monitoring Options Trends O Off or 1 to 9 Resistance High Resistance Pressure On Off 3 Pressure On Optional Features Multi Dose Alert Panel Lock VTBI On Off On Off On Off Optional Modes Dose Rate Calculator Loading Dose Multi Dose Multi Step On Off On Off On Off On Off 92 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Configurable Settings Configurable Settings Continued System Configurable Options Continued Feature Options Default PM Setup 2 Maintenance Interval Maintena
40. 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min User Manual Alaris SE Pump Rev2 X 103 Models 7100 7130 7200 7230 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves Continued Resistance Mode Resistance Mode Start up at 0 1 mL h initial 0 20 0 18 0 16 0 14 0 12 0 10 0 08 120 mL h 0 06 0 04 0 02 0 00 0 02 Time min Resistance Mode Trumpet Curve at 0 1 mL h initial 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 0 1 mL h 48 hr 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Start up at 1 mL h initial 20 1 8 1 6 1 4 1 2 1 0 0 8 0 6 0 4 0 2 0 0 0 2 mL h 0 20 40 60 80 100 120 Time min Resistance Mode Trumpet Curve at 1 mL h initial Flow Rate Error 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 1 mL h 48 hr o al al Flow Rate Error O o A o dx o 0 5 10 15 20 25 30 Observation Interval min 104 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves Continued Resistance Mode Continued Resistance Mode Start up at 25 mL h initial AN f LA Nl UI All qt LU WV UT ML TON UN VAN VA VIU mL h 0 20 40 60 80 100 120 Time min Resi
41. 230 General Information Configurable Settings Configurable Settings Continued Definitions Continued Dynamic Monitoring Pressure Adjustable pressure is designed to monitor IV line site pressure and provide user adjustable pressure alarm limits It is used for Precision Flow mode or for high resistance systems such as infusion through transducers into dialysis systems and through highest resistance catheters The pressure mode may be configured to operate with a fixed pressure alarm limit threshold so that it is not user adjustable Manual Pressure Baseline Provides a real time bar graph and numeric display of line pressure Pressure Alarm When Pressure Display is enabled Pressure Alarm may be set to Adjustable Pressure mode or Fixed Pressure mode Pressure Display In the Adjustable Pressure monitoring mode the pressure alarm limit may be varied from 25 mmHg to the maximum configured pressure limit in 25 mmHg increments The pressure display indicates the current pressure limit and provides the ability to adjust the limit by pressing the increase or decrease arrows In the Fixed Pressure mode the pressure limit of 600 mmHg is displayed with no means of adjusting it When Pressure Display is disabled the instrument automatically defaults to Fixed Pressure mode Pressure Limit Initial Default pressure alarm limit that is automatically set when the instrument is powered on The alarm level must be less than or equa
42. 6 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Drug Specific Dose Rate Calculator DRC Drug Specific Dose Rate Calculator DRC ZETA This is an optional feature that is configured by the facility It allows the clinician to select a drug name to calculate a volumetric rate or a dose rate for continuous drug infusions Ensure the correct entry of all drug The calculation is based on parameters such as drug dosage calculation infusion parameters patient weight and concentration When the calculation is complete the instrument displays the drug name selected on the infusion screen A generic calculation Drug is provided for drugs not available on the drug list When the DRC VTBI has counted down to 0 0 mL the channel switches to the preset KVO rate or remains at the current rate whichever is less Qualified service personnel can turn the DRC feature on or off DRC notes e The patient weight drug concentration and diluent volume cannot be changed during infusion Changes to any of these parameters while on hold recalculates the volumetric rate to maintain the dose rate e All drug names are generic On a dual channel instrument a drug name longer than ten letters scrolls when displayed on the split screen e The Drug selection may be used for calculating when a particular drug name is not available on the drug list e When a drug amount is greater than 10 000 units Un a
43. AAA A dei atacada as pee 112 ELO PIS a lo ii erica 113 ISPS CON ReQquUIFemMe MiS A A a E 116 A O Sosa A orienta sim o 116 SEVICE Into Mao este ens ies 117 TECNICAS UDI a e ae 117 Regulations and Standards COMPLIANCE 119 EICCIFOMAGNEIIG ENVIO MEN ra E a 119 SAA o a eat boro das al Noites 126 Trademark a Sia 126 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 THIS PAGE INTENTIONALLY LEFT BLANK vi User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started introduction Introduction This document provides directions for use for the Alaris SE pump Models 7100 7130 and 7200 7230 It is used in conjunction with WARNING a Read all instructions before using the Alaris SE pump e Instructions for Alaris SE pump administration IV sets e Drug product labeling e Alaris SE pump Technical Service Manual e Ground test equipment instructions R Only e ECG monitoring system instructions The Alaris SE pump is intended for use in professional healthcare environments including healthcare facilities home care and medical transport that utilize infusion pumps for the delivery of fluids medications blood and blood products It is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous IV intra arterial IA subcutaneous epidural enteral and irrigation of fluid spaces The Alaris SE pump is availab
44. CAUTION Variations of head height back pressure time monitoring mode option pump tilt or any combination of these might affect rate accuracy Factors that can influence head height and back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure might also be affected by catheter type See Trumpet and Start Up Curves on page 100 for data on how certain factors influence rate accuracy For rates greater than 1 mL h up to 999 9 mL h 5 95 of time with 95 confidence under conditions listed below For rates equal to or less than 1 mL h 6 5 95 of time with 95 confidence under conditions listed below Rate Accuracy Test Conditions Infusion rate range 0 1 to 999 9 mL h Head height 24 1 in 61 2 5 cm Test solution distilled water Environment temperature 68 8 F 20 4 C Back pressure 0 psi Needle 18 gauge Set Model 72003 Minimum collection volume 6 mL Volume Infused Range 0 0 to 9999 9 mL in 0 1 mL increments VTBI Range 0 1 to 9999 9 mL in 0 1 mL increments Basic Infusion Drug Library Primary Infusion IV Fluid Infusion and Multi Step mode 0 1 to 999 9 mL in 0 1 mL increments all other modes 96 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Symbols and Terms Symbols and Terms a A co Ceppo CE 0086 an gt gt ge ae Alarm indicator Caution Refer to acc
45. ENTER key e Enter a new rate and press ENTER key To program VTBI must be less than primary VTBI perform one of following steps e If current VTBI is appropriate press ENTER key e Enter anew VTBI and press ENTER key To start loading dose infusion press RUN HOLD key To briefly view current profile press KA soft key To change or briefly view primary settings during loading dose infusion press Primary Settings soft key To change settings perform following steps a Press soft key next to parameter to be edited b Enter a new value c To reset volume infused to 0 0 mL press CLEAR or 0 Zero key d To accept new value and begin infusion press ENTER key When loading dose infusion is complete Loading Dose Complete is displayed and primary infusion resumes AB OPTIONS O Multi Step Q 1 Multi Dose af Loading Dose View Curr Settings el return page d __ fale gt OPTIONS a Rate M0 mL en VIBI 500 0 mL ef Primary Settings LOADING DOSE e Ars TT mmHG 0 6 6 OPTIONS ME Rate 200 0 mL VTBI ER mL Primary Settings LOADING DOSE Le q Limit 600 T 6 3 o OPTIONS E Rate 200 0 mL O vrBi E mL Eo of Primary Settings _ LOADING DOSE 2
46. Fusion Service Representative e altered in any way so as to affect in CareFusion s judgment the product s stability or reliability e subjected to misuse or negligence or accident or which has had the product s serial or lot number altered effaced or removed or e improperly maintained or used in any manner other than in accordance with the written instructions furnished by CareFusion This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of CareFusion and CareFusion does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of CareFusion any other liability in connection with the sale or use of Alaris SE pump products CAREFUSION DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION Refer to packing inserts for international warranty if applicable 118 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Regulations and Standards Compliance Electromagnetic Environment This system complies with part 18 of the FCC Rules Operation CAUTION is subject to the follovving tvvo conditions Any changes or modifications not expressiy approved by the personnel responsible for compliance could void the user s authority to operate the system e This system may not cause harmful interference e
47. GHz 2 W At 80 MHz and 800 MHz the higher frequency range applies These guidelines might not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Oo The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHZ to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment might cause interference if inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges d The ISM Industrial Scientific and Medical bands between 150 kHz and 80 MHz are 6 765 to 6 795 MHz 13 553 to 13 567 MHZ 26 957 to 27 283 MHZ and 40 66 to 40 70 MHz User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 125 Regulations and Standards Trademarks Compliance Continued Standards The Alaris SE pump has been assessed and complies with the following standards IEC EN 60601 1 BS 5724 including amendments A1 and A2 IEC EN 60601 2 24 CISPR 11 Group 1 Class A B Emissions IEC EN 60601 1 2 UL 60601 1 CAN CSA No 601 1 M90 Alaris AccuSlide and SmartSite are registered trademarks of CareFusion or one of its subsidiaries All other trademarks belong to their respective owners 126 User Manual Alaris SE Pump
48. IF 0 0mL view settings el Panel Locked e To turn panel lock feature off press and hold until disappears from lower display CE pupam User Manual Alaris SE Pump Rev2 X 69 Models 7100 7130 7200 7230 General Setup and Operation Respond to Maintenance Reminder Respond to Maintenance Reminder If the Preventive Maintenance Reminder option is enabled and ale ame the instrument is due for preventive maintenance a Or Maintenance Reminder message appears at power up e Maintenace 1 Notify appropriate facility personnel if a Maintenance el dci Reminder message appears C Es 2 If necessary press continue soft key to temporarily ry ry e bypass reminder Nurse Call 7130 7230 Only If the instrument is equipped with the optional nurse call feature alarms and some alerts from the instrument are relayed to the hospitals existing nurse call system No instrument operating features are changed The instrument alarms with or without the nurse call installed Activate Nurse Call Feature 1 Plug nurse call cable into RS 232 connector on instrument s rear panel 2 Press POWER key Instrument beeps briefly to signal proper operation 3 Plug nurse call cable into nurse call system 4 Operate instrument as described in this document 2 1 A false remote alarm might
49. If problem persists do not use instrument Contact qualified service personnel Key Stuck A key is stuck or was held down Release key Turn instrument off too long and then on If problem persists do not use instrument Contact qualified service personnel Latch Open Latch was opened during an Check for proper set installation infusion Close latch fully to the left Press run soft key No Upstream Flow Detected Flow is obstructed between Check to see if container is empty container and instrument when flow sensor is mispositioned or using a flow sensor clouded tubing is kinked or air vent is closed Verify correct set connections and open fluid path Press run soft key to restart infusion Infusing fluids which form smaller drops through a 60 drops mL set at high rates might result in a No Upstream Flow Detected alarm small rapidly falling drops form a continuous stream that does not trigger the flow sensor In this event unplug the flow sensor from the instrument 110 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance Alarms Alerts Prompts Alarms Alerts Prompts Continued Alarms Continued Alarm Meaning Response Occlusion Downstream Pressure in IV line exceeded a Check administration set for pressure alarm threshold probable cause such as kinked tubing closed stopcock high resistance catheter Press run soft key to restart infusion
50. K is used to indicate a value multiplied by 1 000 for example 1 000 000 1 000K e DRC cannot be used in conjunction with secondary or other operating modes User Manual Alaris SE Pump Rev2 X 27 Models 7100 7130 7200 7230 Programming Drug Specific Dose Rate Calculator DRC Drug Specific Dose Rate Calculator DRC Continued Program 1 Select the desired channel as necessary 2 Press OPTIONS key Cala OPTIONS ON Rate 250 mL Qua VTBI 4 0 mL ef 1 0 mL ol a e y G Resistance e 6 3 Press Dose Rate Calculator soft key aps OPTIONS l o Resistance Trend 4 Monitoring Options Dose Rate Calculator mM Set Pressure Baseline Qi return page mb dd d 4 Press Enter New Program soft key als arros ON DOSE RATE MENU 0 1 Review Resume e Enter New Program pe Program 6 6 1 The channel must be infusing in the primary mode or on hold in the primary mode secondary mode or a loading dose program 28 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Drug Specific Dose Rate Calculator DRC Drug Specific Dose Rate Calculator DRC Continued Program Continued 5 Press soft key corresponding to applicable drug To view additional drug name selections press page soft key e If desired drug
51. ONS DOWNSTREAM alarm occurs Or A eo OCCLUSION La DOWNSTREAM e el 600 mmHg run So end Auto Restart Plus Feature The Auto Restart Plus feature provides the ability to automatically continue an infusion if downstream pressure measurements indicate that an occlusion condition has cleared within a 40 second Checking Line period excluding High Resistance Monitoring mode The Checking Line message and tone occur whenever a pressure measurement exceeds the selected alarm threshold If the pressure falls to less than one third of the alarm limit within 40 seconds normal flow resumes The Adjustable Pressure mode allows control of the pressure alarm limit If the condition is not cleared the OCCLUSION DOWNSTREAM alarm occurs and infusion stops until manually restarted User Manual Alaris SE Pump Rev2 X 57 Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Options Pressure Mode Continued Auto Restart Plus Feature Continued This feature can be configured through the hospital configuration settings to allow from one to nine Checking Line restarts After the programmed number of restarts has occurred or the 40 second Checking Line period has been exceeded the channel immediately alarms OCCLUSION DOWNSTREAM when resistance or pressure conditions indicate an occlusion Adjustable Pressure Alarm In the Adjustable Pressure monitoring mode the pressure alarm l
52. Step Multi Dose Continued Quit Multi Dose The channel must be on hold or the last dose complete 1 Press menu soft Rey 2 To return to primary setup page press Quit Program soft key Primary setup page parameters might be different than those for the Multi Dose program Verify all settings prior to resuming an infusion This is an optional feature that is configured by the facility Options are enabled through the instrument configuration settings The Multi Step feature allows a sequential drug delivery program up to nine steps to be set delivering volumes of fluid at different rates during each step This allows the instrument parameters to be set up once and to deliver a sequence eliminating the need to change the rate and VTBI after each infusion step The infusion may be programmed in either rate and volume or volume and time At completion of the last programmed step the channel switches to the preset KVO rate or remains at the current rate whichever is less 1 Select desired channel as necessary Channel must be on hold in primary mode 2 Press OPTIONS key 3 Press Multi Step soft key 4 Press Enter New Program soft key 40 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Multi Step Multi Step Continued Program Continued 5 Determine applicable setup method as follows e Rate and Volume Instrument calculates step infusion time Se
53. Step Continued Resume an Interrupted Infusion The channel retains its place in the program if the instrument is turned off The program can be restarted from step 1 or be resumed where it left off 1 Select desired channel as necessary Return To Multi Dose page is displayed 1 2 Press yes soft key 2 AJB OPTIONS A go Return To e Multi Step gi no yes d 3 Press Review Resume soft key Als OPTIONS o MULTI STEP MENU ge Review Resume el Enter New Program el Quit Program N 4 To resume program from point of interruption press aTe OPTIONS Continue Program soft key Oy E OR go In Progess o e Continue Program To restart program at beginning of step 1 press Restart Du Restart Program Program soft key O menu 5 Verify that all settings are correct If a change is required 6 6 see View Steps or Make Changes on page 44 1 If resuming an infusion on a dual channel instrument with an infusion currently running the display goes directly to Return To Multi Step during startup 2 Pressing no soft key returns screen to primary setup page 46 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Multi Step Multi Step Continued Resume an Interrupted Infusion Continued 6 To approve review page and STEP TOTALS page press
54. This system must accept any interference received including interference that might cause undesired operation The digital apparatus does not exceed the Class B limits for radio noise emissions from digital apparatus set out in the radio interference regulations of the Canadian Department of Communications DOC Le present appareil numerique n emet pas de bruits radiolelectriques depassant les limites applicables aux appareils numeriques de la Classe A B prescrites dans le reglement sur le brouillage radioelectrique edicte par le Ministere des Communications du Canada This system has been tested and found to comply with either the limits for a Class B digital device without Model 180 Flow Sensor or as a Class A digital device with Model 180 Flow Sensor pursuant to Part 18 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the system is operated in a commercial environment This system generates uses and can radiate radio frequency energy If it is not installed and used in accordance with the applicable directions for use it might cause harmful interference to radio communications Operation of this system in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their own expense The authority to operate this system is conditioned by the requirement that no modifications will be made to the syst
55. User Manual Alaris SE Pump Models 7100 7130 and 7200 7230 Rev2 X April 2011 General Contact Information CareFusion San Diego California United States Authorized EU Representative CareFusion The Cresent Jays Close Basingstoke Hampshire RG22 4BS United Ringdom carefusion com Customer Advocacy North America Clinical and technical feedback Phone 888 876 4287 E mail CustomerFeedback carefusion com Customer Advocacy International Clinical and technical feedback E mail cai carefusion com Technical Support North America Maintenance and service information support troubleshooting Phone United States 888 876 4287 Phone Canada 800 387 8309 Technical Support United Kingdom Maintenance and service information support troubleshooting Phone 0800 389 6972 E mail UK Technical Support carefusion com Customer Care North America Product return service assistance and order placement Phone United States 888 876 4287 Phone Canada 800 387 8309 Customer Care United Kingdom Product return service assistance and order placement Phone 0800 917 8776 E mail UR Customer ServiceQcarefusion com Technical Support and Customer Service International Maintenance and service information support Product return service assistance and order placement www carefusion com customer support custome
56. able Pressure Mode Continued 4 Press Set Pressure Baseline soft key Set Pressure Baseline screen appears 5 Verify that no pressure due to occlusion or other infusions through a common line is present in IV line 6 For best results verify that set outlet for example stopcock is located at patient s heart level 7 Press ok soft key A B OPTIONS Set Pressure Baseline aes return ok 5 4 Verify that pressure readout is 0 zero mmHg 7 ee 1 To return to the normal screen without setting the baseline press the return soft key 2 True baseline pressure will be zero or within a few mmHg of zero If not and the pressure is unstable allow the pressure to drop to the lowest level and then repeat the Set Pressure Baseline process aJe OPTIONS ON Rate 125 0 mu s VTBI 500 0 mL rv New 54 Baseline el Set i 6 6 al OPTIONS Rate 125 0 mL h VTBl 1000 0 mL VI 0 0 mL es ee 0 mmHg d E User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 61 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Options Pressure Mode Continued Pressure Baseline Continued 9 Pressure Trend Graphs Manually Set Pressure Baseline While Operating in Adjustable Pressure Model Continued To start
57. act qualified CareFusion service personnel If it is necessary to return the instrument for service obtain a return authorization number prior to shipment Carefully package the instrument preferably in the original packaging reference the return authorization information and return it to the appropriate service or distribution center CareFusion does not assume any responsibility for loss of or damage to returned instruments while in transit Technical Support Technical support service information applications and manuals may be obtained by contacting a CareFusion representative When submitting any request for service include e model number e a description of difficulty experienced e instrument settings e administration set lot number e solution s used e message displayed at time of difficulty The instrument case should only be opened by qualified personnel using proper grounding techniques Prior to performing maintenance disconnect the Alaris SE pump from AC power During servicing an instruments configuration settings might be reset to the factory defaults Qualified hospital facility personnel are responsible for checking in the instrument and ensuring that the current hospital approved instrument system configuration settings are correct User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 117 Troubleshooting and Maintenance Service Information Warranty CareFusion war
58. anes 52 Auto Restan PIUS FO QUE totor A a 53 REeSIStance AISR ns er oe Dada 94 Resistance FENG PAS cocina 55 Monitoring Options Pressure Mode c ooccoccncocccccccoccccncncncnnonnnoncnnnononnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnns 57 Downstream Occlusi n DetecUONM ecir E E es 57 AUO Restart PIUS CSUC Cit nat Dec a a aia a a aA 57 AAUStaDIE PFESS URS ALAIN di 58 Pressi DOS CME unida a ali e 60 Pressure Trend ORDIS Bt iii 62 Upstream Occl sions DetectioN mari td pois 64 General Setup and Operation A tia ala tac at lema eds 67 1 ES mea me mentat cates tea anette st as cede ten ees tetoes 67 RO AO O A e eee 68 A tot tn 68 Tamper Resist Panel Lock Feature ooocooccconcccnconcconococconocononnnconononooncnonononcononanenancanenanenaninnos 69 Respond to Maintenance Reminder ccccccecceseceeeeeeceeecueeceecesecaeeseueaeeceueseeseesauesseesenseeesenesseesanes 70 Nurse Gale 1 90 7230 ONY icones cie Ec can Serene Secale a a eases tedeeceee 70 Activate Nurse Call Feature winds ee ee ae lo 70 anA OC CES eis ts ca In A 71 R9 2929 Computer LINK o echo eenals 71 Connect to a Computer vestir and eos li il Auden 71 Disconnect roma Computer cic a ad 72 General Information Wamings and CAU UONS cit recs messi at 73 A aA 3 FXCIMIMISW ALON SOS lc olla 75 EDIGUFall AGIMIAISU ALIOM A eds 15 Electromagnetic Compatibility cooccoocncconcconcconnoconononoconcnonccnonononcnnnonannonnnonannn
59. annel A or Channel B to indicate which channel is affected Always verify that the channel is selected before making any changes ALARM instrument or channel problem e infusion stops e alarm bell icon illuminates e alarm tone sounds e rate LED display flashes e message appears in Main Display when channel is selected Opening the latch or turning the channel off clears air memory 108 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance Alarms Alerts Prompts Alarms Alerts Prompts Continued ALERT possible change in infusion status e channel continues to operate e alert tone sounds e message appears in Main Display PROMPT infusion status not changed Startup procedures were not completed or an invalid key was pressed Meaning Response Accumulated Air In Line Air detector detected multiple Press hold soft key Open latch to small bubbles remove set Clear air per hospital protocol Reinstall set Press RUN HOLD to resume infusion OR If reset key is active and air bubbles are clinically insignificant press reset soft key and then press run soft key to resume infusion Ensure air in line sensors are thoroughly cleaned Air In Line Air detector detected an air Press hold soft key Open latch to bubble larger than configured remove set Clear air per hospital threshold tolerance protocol Reinstall set Press RUN HOLD to resum
60. anonannnnnnenons 76 Battery Management Stem some cele e AA 171 Battery Power Gauge and Indicator ccoocccocncccncnoccccnnncccncnononononnnncnnnnnnnnnnnonnnnnnnnnnnnonnnnnnnnonenonens 78 Battery TROCMANGG deien temes te sin aO 78 Battery Replacement and Disposal oocoocccoccocncocncocononcnconocononcnnnnnnonononnnnnnonnronnronrnnnnnaronnnnnnnnanenas 78 FOW SENSON PP a bates aa eee ae muah sana basses T a oauatete 79 Fealures ana DIS pla Sua lso ios 81 Operating Features Controls Indicators cocccocccoccccnconnconiccncnnnconocononnonononononronononnnnanonanonos 81 Displays ana SOMO Sisa lc iria 84 COnIGUTADIE SCUINGS it etc SU a cle isla 87 BS F Pe mei sers co totalitat eres tateteia 87 Conmtigurable OPTIONS a coo 92 SpecmcatlOns ricardo daba 94 SVMDOIS ANC TEMS e barat cames 97 Trumpet and StartUD CUIVOS ii ia 100 Flow Characteristics Under Varying Delivery Conditions ccooccccocccccncccncccnconcnononcnnnnoncnnncnnncnnnons 101 Pressure Mode casta tud Ges meca Ges ae o imita tia anat ci 102 Resistance Mode setma meses Edit teal cate Sadat ds 104 High Resistance Mode asis oo 106 IV User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance AICLE AASSEMIDIY emet tenen ves ered ee Ni cena aden ikea eaten ee Motes 107 FAI UD DIS Detecta imat oci 108 Alarms Aler S PIOMDIS Gema sa sges acres ee eta Recerca eta 108 A A A A mt et estats 109 PAIGTUS iii
61. art Plus feature is off OCCLUSION DOWNSTREAM alarm occurs OPTIONS _ are ME Rate 125 0 mL h 1 TBI 1000 0 mL 0 0 mL a VI v a al Resistance Alert 6 OPTIONS AJB Ara 125 0 mL h 4VTBI 1000 0 mL Vi 0 0 mL Checking Line O T 0 OPTIONS OCCLUSION Lee A DOWNSTREAM eu e 92 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Resistance Mode Monitoring Options Resistance Mode Continued Auto Restart Plus Feature The Auto Restart Plus feature provides the ability to automatically continue an infusion if downstream resistance or pressure measurements indicate that an occlusion condition has cleared within a 40 second Checking Line period excluding High Resistance Monitoring mode The Checking Line message and tone are presented when a resistance measurement exceeds the alarm threshold of 100 If resistance measurements initiate the Checking Line BI options condition the channel continues infusing in order to determine La ee ener if the measured flow resistance has changed If the measured 4VTBI 1000 0 mL flow resistance falls to any value below 100 within ya VI 0 0 mL 40 seconds the channel aut
62. as follows Continue infusing from step 8h Verify that rate is set to 460 mL h Clamp off IV line just below insttument about two inches to simulate a downstream occlusion Allow instrument to run until it alarms OCCLUSION DOWNSTREAM Verify that this occurs within 60 seconds Press RUN HOLD key to silence alarm and put instrument on hold Release or open clamp and remove from tubing Press RUN HOLD key to resume infusion Alarm should not reoccur Press RUN HOLD key to stop infusion Flow Stop Test 1 With an administration set primed and loaded in instrument turn power off With all tubing clamps open and fluid container two or more feet above instrument verify that no fluid flows through set Open latch and remove set Verify that no fluid flows through set User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Storage Check in and Configuration Continued Ground Current Leakage Test Use a DNI Nevada Model 232D or equivalent to measure the ground leakage current Refer to the test equipment s operation manual for the proper setup and measurement technique Leakage current must be lt 100 uA for normal and reversed line polarity Ground Resistance Test Use a DNI Nevada Model 232D or equivalent to measure the CAUTION ground resistance Measure resistance from the AC povver plug ground pin to the screw for the power cord strap or to the Do not c
63. at manual pressure baseline setting Set Out Flow Regulator segment is not installed correctly Reinstall Flow Regulator segment Set Pressure Baseline Set Pressure Baseline was selected in options mode Press ok soft key to set Pressure Baseline or press return soft key to go to exit Set Pri VTBI A primary VTBI was not programmed Enter a primary VTBI Set Pri VTBI gt Loading Dose VTBI Loading dose VTBI entered is greater than primary VTBI Raise primary VTBI or lovver loading dose VTBI as appropriate Stop Timer to Change An invalid Rey vvas pressed vvhile timer vvas running in Multi Dose program VVait several seconds for popup to finish Press stop timer soft key to make changes Time Out of Range Programmed step time exceeds 24 hours and 59 minutes or is less than 1 minute Invalid Keypress During Programming Verify and reenter settings The following Prompts might be seen if an invalid key is pressed during programming Both A and B not Running Channel Not On Complete or OK Setup No Numeric Entries Select Channel Invalid Keypress During Infusion During an infusion if an invalid key is pressed the following prompts might be seen Dose Rate Running Loading Dose Running Multi Dose Running Multi Step Running Pri Running Sec Running or Timer Running Multi Dose program User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230
64. ates greater than 1 mL h and up to 999 9 mL h and 6 5 for rates equal to or less than 1 mL h 95 of the time with 95 confidence see Trumpet and Start Up Curves on page 100 for additional information The system performance with a calibration set produces a smaller variability In order to ensure overall accuracy is achieved new instruments are tested to an accuracy of 3 with the Model 80VCS set during a new instrument check in Due to the dynamic monitoring feature the rate is varied during operation For this reason CareFusion does not recommend using automatic testers to check rate accuracy Generally these devices collect small samples and might cause the results to be incorrect even though the instrument is accurate Do not use the Model 80VCS Calibration Set for more than 30 rate verification runs 15 rate calibration number changes Keep track of the number of times the set is used by recording each use on the 80VCS insert or on a separate record 4 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check in and Configuration Continued Rate Accuracy Qualification Test Continued Test Setup po RA Burette Clamp Equipment Stand Burette 50 ml 1 Source 30 1 in 6 2 2 5 cm Table or B
65. before cleaning 1 Excluding 10 bleach solution in water EZA Turn the instrument off and unplug the power cord from AC power before cleaning Do not spray fluids directly onto the instrument or into any connector Do not steam autoclave EtO sterilize immerse the instrument or allow fluids to enter the instrument case Failure to follow these instructions might result in an electrical hazard CAUTION The solutions solvents identified as NOT to be used can damage the surfaces of the instrument 116 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance Service Information Cleaning Continued N Verify that RS 232 connector is covered o Use a soft cloth dampened vvith vvarm vvater and a mild nonabrasive cleaning solution e Asoft bristled brush may be used to clean narrow areas e Use light pressure when cleaning pressure transducer and air in line detector areas of pumping channels gt Routinely clean flow sensor by running warm water over it while actuating slider and then thoroughly dry it Service Information If the instrument shows evidence of damage in transit notify the carrier s agent immediately Do not return damaged equipment to the factory before the carrier s agent has authorized repairs If the instrument fails to respond as described in this document and the cause cannot be determined do not use the instrument Cont
66. d level in drip chamber must be checked re established after each empty container condition e When using flow sensor option while ambulating or transporting a patient from one area to another use care to avoid excessive swinging of solution container 3 Attach flow sensor to instrument handle when not in use 4 Routinely clean flow sensor with warm water while CAUTION actuating slider and then dry thoroughly Do notuse solvents ordena agents Damage to plastic parts of the flow sensor might occur 80 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Features and Displays Features and Displays Operating Features Controls Indicators Single Channel Model PRI SEC e E IEA ea PoveR e co A HOLD I 4 still o NN ml hr OPT PRI HLD SEC KVO Power Key Turns instrument on and off Power Indicator Green Plugged in and charging Flashing Amber Battery power Infusing Indicator Indicates instrument is infusing Alarm Indicator Indicates instrument is in alarm and has stopped infusing RUN HOLD Key Starts and stops infusion OPTIONS Key Accesses additional features Secondary SEC Key Selects secondary mode Primary PRI Key Selects primary mode Soft Keys See Displays and Soft Keys on page 64 ENTER Key Accepts value or selection
67. de resistance alert and or pressure alarm limit If the monitoring mode resistance alert and or pressure alarm limit are not verified the instrument might not operate within the desired occlusion detection parameter s e Before each use verify that the pressure or resistance alarm limits are appropriate for the patient e A new alarm or alert reinstates the audio tone e Assess patient s condition before silencing an alarm Do not silence alarm if patient safety might be compromised e Disconnect from main AC and battery power when performing maintenance User Manual Alaris SE Pump Rev2 X 73 Models 7100 7130 7200 7230 General Information VVarnings and Cautions Warnings and Cautions Continued General Continued MG e To disconnect from main AC unplug the power cord from the back of the instrument e Electrical shock hazard Do not open case Refer to qualified service personnel CAUTION e The Alaris SE pump is not intended to replace supervision by medical personnel The user must become thoroughly familiar with the Alaris SE pump features operation and accessories prior to use e Always use a grounded three wire receptacle Where the integrity of the protective earth grounding system is in doubt operate on internal battery e If an instrument or accessory is dropped or severely jarred immediately remove it from use and have it inspected by qualified service personnel to ensure
68. e baseline User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 113 Troubleshooting and Maintenance Alarms Alerts Prompts Alarms Alerts Prompts Continued Prompts Continued Prompt OR Entry Meaning Attempt vvas made to go to another page before pressing ok soft key Response Verify that all parameters are correct and press ok soft key Panel Locked A key was pressed Panel lock feature is on Turn panel lock off to access panel controls Panel lock key is located behind handle Place on Hold to Change A key was pressed during KVO Channel must be on hold to make changes Place on Hold to Set Pressure Baseline SET PRESSURE BASELINE function was selected while running Pressure Baseline feature is on Place instrument on hold before performing manual SET PRESSURE BASELINE operation Press and Hold Key to Turn Off POWER key was pressed Press and hold POWER key until display turns off Pressure Limit XXX mmHg XXX represents configured maximum pressure An elevated pressure was present in fluid path when pressure baseline was established This might reduce maximum available pressure range Reload administration set and verify that no obstruction exists which could cause excess pressure e If Pressure Baseline feature is on repeat manual setting of pressure baseline e If Pressure Baseline feature is off restart infu
69. e 87 for a list of the configurable features Check In and Configuration This is a quick reference procedure for check in and WARNING configuration of new and recently serviced instruments Instruments returned from the e Rate Accuracy Qualification Test Rate Verification service depot might be set to e Set Sensor Check Pressure Calibration Verification factory defaults Biomedical e Functional Test personnel in the facility are e Flow Stop Test responsible for checking in the e Ground Current Leakage Test instrument and ensuring the current Ground Resistance Test hospital approved configurations are e Instrument Configuration loaded CAUTION Charge the battery for a minimum of 24 hours prior to performing the check in and configuration procedures Batteries without a full charge on initial use might become damaged and or cause a malfunction User Manual Alaris SE Pump Rev2 X 3 Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Rate Accuracy Qualification Test This procedure is to be used only when testing an instrument during a new instrument check in or when just received from the service depot center This test is to verify that damage or changes to the instrument did not occur during shipment and handling Rate accuracy should be tested using a Model 80VCS Calibration Set The system is designed to produce overall accuracy of 5 for r
70. e Primary rate Pri Rate primary volume to be infused Pri VTBI and total volume infused Total VI are displayed e Display returns to normal secondary page after six seconds The secondary mode must be set to ON in the instrument system configuration settings If the secondary mode is OFF an invalid keypress tone sounds and Secondary Not Allowed is displayed when the SEC key is pressed User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Secondary Infusion Secondary Infusion Continued Infusion Continued 8 To change Primary settings press soft Rey for Pri Rate Pri VTBI or Total VI to freeze display and highlight desired value and then edit as usual 9 When secondary infusion is complete e An audio tone sounds if enabled e Channel Secondary Complete is briefly displayed e Infusion automatically transitions to primary rate Change Parameters During Infusion Change Secondary Parameters 1 Select desired channel as necessary 2 Press soft key next to parameter to be edited Current value is highlighted Care OPTIONS Gu OPTIONS OD ato To mL h ON Rate 100 0 mL Qua VTBI 50 0 mL Qua VTBI EN mL ef settings ef NT settings el e eo mmHG r lt T mmHG r o 3 Enter a new value and press ENTER key Change Primary Settings 1 Select desired channel as necessary
71. e Program Rate and Volume on page 41 e Volume and Time Instrument calculates rate See Program Volume and Time on page 43 Program Rate and Volume 1 Press Rate and Volume soft key A B OPTIONS a PROGRAMMING OPTIONS E Q Rate and Volume ar and Time el menu e 6 2 Enter a rate and press ENTER key AB OPTIONS o STEP 1 GO Rate EES L h e VTBI mL g Time h min el menu o 6 3 Enter VTBI and press ENTER key aTe OPTIONS Time in hours and minutes is automatically calculated and o STEP 1 displayed Gi Rate 25 0 mL h e VIBHE mL La Time h min menu 5 4 4 To approve all displayed information and advance to Tala OPTIONS STEP 2 of infusion sequence press ok soft key O a STEP 1 Rate 25 0 mL h es VTBI 5 0 mL Time 0 h 12 min el menu Oh 5 4 User Manual Alaris SE Pump Rev2 X 41 Models 7100 7130 7200 7230 Programming Multi Step Multi Step Continued Program Continued Program Rate and Volume Continued 5 To set up each additional step of infusion sequence repeat steps 2 through 4 6 When all s
72. e infusion OR If reset key is active and air bubbles are clinically insignificant press reset soft key and then press run soft key to resume infusion At flow rates of 1 0 mL h and below verify that upstream fluid path is unobstructed Ensure air in line sensors are thoroughly cleaned Battery Depleted Plug In Battery is too low to operate Plug power cord into an AC outlet instrument immediately Press run soft key or RUN HOLD to resume infusion User Manual Alaris SE Pump Rev2 X 109 Models 7100 7130 7200 7230 Troubleshooting and Maintenance Alarms Alerts Prompts Alarms Alerts Prompts Continued Alarms Continued Alarm Meaning Response Channel Malfunction Channel malfunction Turn channel off and then on If Dual channel instrument only problem persists do not use channel Contact qualified service personnel Computer Link Failure RS 232 connection to computer Check RS 232 connections was disrupted Computer Link feature is in Clearing this alarm automatically monitor mode puts instrument in monitor mode Re establish infusion Flow Sensor Unplugged Flow sensor is unplugged from Plug flow sensor into flow sensor back of instrument receptacle Hold Time Exceeded Channel has been on hold fortwo Press hold soft key to return to hold minutes and no keys have been mode pressed Instrument Malfunction Instrument malfunction Turn instrument off and then on
73. e other than those specified might result in increased emissions or decreased Alaris SE pump immunity CAUTION e Do not use the Alaris SE pump adjacent to or stacked with other equipment If adjacent or stacked use is necessary observe the Alaris SE pump to verify normal operation in the configuration in which it will be used 76 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Battery Management System Warnings and Cautions Continued Electromagnetic Compatibility Continued e Portable and Mobile RF communications can affect Medical Electrical Equipment e The Alaris SE pump is intended for use under the supervision of healthcare professionals only This is a CISPR 11 Class B device without the use of the Model 180 Flow Sensor and CISPR 11 Class A when the Model 180 Flow Sensor is used In a domestic environment this system might cause radio interference Reorienting relocating or shielding the system or filtering the connection to the public mains network are examples of steps that can be taken to reduce or eliminate interference Battery Management System The Battery Management System incorporates features that enhance battery maintenance in order to maximize the life of the battery reduce associated costs and increase instrument availability The system provides the following features e Green gf lights when instrument is plugged in e Amber af flashes
74. eight in kg Height cm inches el 5 To approve all displayed information and advance to first setup page press ok soft key Drug Name Not Listed 1 To use generic dose calculation feature navigate using _ pil Corrs the page soft key and press the Drug option gt e e S menu page 2 To scroll through available units press and release Fay soft key e Weight based dosing versus non weight based dosing perform one of following steps o Weight based dosing Press ENTER key to advance to time segment o Non weight based dosing Press EM soft key to clear segment and then press ENTER key weight field disappears 30 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Drug Specific Dose Rate Calculator DRC Drug Specific Dose Rate Calculator DRC Continued Program Continued Drug Name Not Listed Continued e Time unit perform one of following steps o If time unit is appropriate press ENTER key to advance to concentration field o Press E soft key to scroll through available time unit choices Press ENTER key when correct unit is displayed e Concentration unit perform one of following steps o If concentration unit is appropriate press ENTER key to advance o Press lA soft key to scroll through available concentration unit choices Press ENTER key when correct unit is dis
75. elivered when changing from secondary to primary This is to account for overfill of secondary containers If a flow sensor is not connected to the instrument ensure that protective plugs are installed at the connector site to prevent entry of foreign material 1 Plug a Model 180 Flow Sensor into applicable channel connector on back of instrument 2 Attach flow sensor to upper portion of drip chamber e When using a flow sensor correct placement is essential for proper operation o Some administration set drip chambers have a flange to which a flow sensor can be attached Attachment on flange ensures proper placement o Upper surface of flow sensor should be slightly below drop forming orifice but above level of fluid in drip chamber WARNING ml The protective cover over the RS 232 connector must remain in place when the connector is not in use Flow Sensor Connectors CAUTION Infusing fluids which form smaller drops through a 60 drops mL set at high rates might result in a No Upstream Flow Detected alarm This is because the small rapidly falling drops form a continuous stream that does not trigger the flow sensor In this event unplug the flow sensor from the instrument User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 79 General Information Flow Sensor Flow Sensor Continued o Ensure that drip chamber is at least full and sensor optics are clean Flui
76. em unless the changes or modifications are expressly approved by CareFusion User Manual Alaris SE Pump Rev2 X 119 Models 7100 7130 7200 7230 Regulations and Standards Compliance Compliance Continued Electromagnetic Environment Continued This Class A B digital apparatus meets all requirements of the Canadian Interference Causing Equipment Regulation Cet appareil numerique de la Classe A B respecte toutes les exigences du Reglement sur le materiel brouilleur du Canada Tables The Alaris SE pump is intended for use in the electromagnetic environments specified in the following tables Table 1 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance CISPR 11 The Alaris SE pump is suitable for use in all establishments RF Emissions including domestic establishments and those directly connected to a public low voltage power supply network that supplies buildings used for domestic purposes provided the following Caution is heeded CAUTION The Alaris SE pump is intended for use under the supervision of healthcare professionals only This is a CISPR 11 Class A when the Model 180 Flow Sensor accessory is used and a CISPR 11 Class B when the Model 180 is not used In a domestic environment this system might cause radio interference Reorienting relocating or shielding the system or filtering the connection to the public mains network are examples of steps that can be taken
77. ench Es D vas any Used Fluid Receptacle Fill solution container vvith clean tap vvater Ma 80VCS Calibration Set Instrument Stand Close AccuSlide flow regulator clamp on 80VCS set and then insert spike into solution container Open AccuSlide flow regulator clamp and prime set Ensure that all air is expelled from set Close AccuSlide flow regulator clamp Connect output of set to one side of three way stopcock Load set into instrument and close latch Verify no fluid flow or drops falling in drip chamber User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Rate Accuracy Qualification Test Continued 8 Plug instrument into a properly grounded AC outlet 9 Set stopcock to output into a class A or B burette 10 Press POWER key to turn channel on 11 Set primary infusion rate to 400 mL h 12 Set VTBI to 20 mL 13 Ensure that instrument both channels if dual channel is set to Pressure mode 14 Press RUN HOLD key to start primary infusion Infuse until tubing and burette are fully primed approximately one minute 15 Press RUN HOLD key to stop infusion 16 Adjust height of instrument and or fluid container to attain a head height of 30 1 inches 76 2 2 5 centimeters between middle of pumping mechanism and fluid level in one of following
78. er and hang secondary container following accepted hospital facility procedure 3 Fill drip chamber to full 4 Open secondary administration set clamp and prime set 5 Close clamp 6 Attach secondary administration set to upper injection site on primary set 7 Using hanger s provided with secondary administration set lower primary fluid container until bottom of secondary container is at least 974 inches above fluid level in primary container Hanger Secondary Container at least 91 2 P Primary Container Es H z User Manual Alaris SE Pump Rev2 X 23 Models 7100 7130 7200 7230 Programming Secondary Infusion Secondary Infusion Continued Place primary infusion on hold by pressing RUN HOLD key ND Oa gt D o N Press SEC key e Secondary setup page is displayed e Secondary rate is highlighted If current secondary infusion rate is appropriate perform one of the following steps e Press ENTER key e Enter a new rate maximum allowed rate is 270 mL h and then press ENTER key Secondary VTBI is highlighted If Secondary VTBI is appropriate perform one of the following steps e Press ENTER key e Enter a new VTBI and then press ENTER key To start secondary infusion press RUN HOLD key Verify that secondary clamp is open before proceeding and then press yes soft key To briefly view primary settings during secondary infusion press Primary Settings soft key
79. es o si ROER e stop timer dd d 4 To briefly view multi dose programmed information press Are oPrions soft key 0N Rate 250 0 mLh VIB1 100 0 mL al 100 0mL 250 0mL h e Q6hx4 VI 100 0 o Adult ICU 6 Change Time Interval Until Next Dose 1 Press stop timer soft key AB OPTIONS gt 12 min ay Until Dose 2 of 4 La stop timer 6 6 User Manual Alaris SE Pump Rev2 X 37 Models 7100 7130 7200 7230 Programming Multi Dose Multi Dose Continued Program Continued Change Time Interval Until Next Dose Continued 2 Press soft key next to value to be edited fall OPTIONS Return To Multi Dose page is displayed o o lg Until Dose 2 of 4 el VI 100 0 mL el menu start timer 5 4 3 Enter new value and press ENTER key _ REI ole 4 When editing is complete press start timer soft key 2h Qua 12 min el Until Dose 2 of 4 Vl 100 0 mL el menu start timer Resume an Interrupted Multi Dose Select desired channel as necessary Return To Multi Dose page is displayed 2 Press yes soft key Gn ree Pressing no soft key returns screen to primary setup page Oy go Return To Multi Dose o G no yes d 38 User Manual Alaris SE Pump Rev2 X
80. es in Main Display Resume Infusion from KVO Mode 1 To place channel on hold press RUN HOLD key 2 Press VTBI soft key VTBI is highlighted 3 Enter desired VTBI 4 Press ENTER key 5 To resume infusion press RUN HOLD key User Manual Alaris SE Pump Rev2 X 21 Models 7100 7130 7200 7230 Programming Secondary Infusion Primary Infusion Continued Clear Volume Infused The volume infused counter increments as fluids are infused through a given channel All fluids infused in primary mode all fluids infused in secondary mode and all fluids infused in KVO mode are counted 1 To reset volume infused counter to 0 0 mL press VI soft key 2 Press CLEAR or 0 zero key and then press ENTER key Secondary Infusion This mode is designed to support automatic secondary infusions piggybacking in the same channel When the e Secondary applications require the instrument is programmed and delivering in the secondary use of a check valve set on the mode the primary infusion is temporarily stopped and fluid is primary IV line drawn from the secondary container e The secondary solution container must be higher than the primary The primary infusion must be programmed and on hold before solution container a secondary infusion is programmed The maximum rate for a k Gen The secondary VTBI settings secondary Infusion is 270 mL h require consideration of variables such as factory overfill and
81. essure the Alaris SE pump typically exhibits a long term accuracy offset of approximately 1 5 from mean values Under conditions of 100 mmHg pressure the Alaris SE pump typically exhibits a long term accuracy offset of approximately 0 8 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under these pressure conditions Effects of negative solution container heights With a negative head height of 0 5 meters the Alaris SE pump typically exhibits a long term accuracy offset of approximately 5 8 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under negative head height conditions Effects of rate For applications where flow uniformity is a concern use of the Pressure Mode at rates of 1 0 mL h or above is recommended User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 101 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves Continued The plot range has been increased to 100 to allow visualization of the graph Legend mM Maximum rate error Overall rate error Minimum rate error Pressure Mode Pressure Mode Start up at 0 1 mL h initial Pressure Mode Start up at 1 mL h initial WN hdl NN WH init 0 10 mL h E 0 08 J
82. ew calibration number e If result is outside a range of 5 5 to 7 0 from expected volume return instrument to CareFusion for repair or replace mechanism 2 Empty flask and reset scale to zero in preparation for next test Set Sensor Check Pressure Calibration Verification 1 Access DIAGNOSTICS MODE by pressing and holding _ AB oPnons upper left soft key on power up For details refer to Or SONS CST CE 5 Technical Service Manual Troubleshooting chapter for ID No 000000000 details or contact CareFusion Technical Support Ja SW Rev XX XX 7 O PM Due 52 weeks XX XX in illustrated display represents current software el revision di 2 Advance to D6 page and choose Cal Pressure both Channel A and Channel B for dual channel instruments 3 Verify that both 0 mmHg and 500 mmHg readings indicate Pass User Manual Alaris SE Pump Rev2 X 11 Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Set Sensor Check Pressure Calibration Verification Continued 4 Install a standard set and close latch Verify that reading is over 170 to confirm set sensor operation 5 Remove standard set and verify that Sensor reading is in 80 mmHg to 30 mmHg range to verify pressure calibration If reading is out of range refer to Technical Service Manual Pre
83. fusion 21 Instrument runs approximately 360 seconds six minutes to complete delivery and then goes into RVO mode Stop instrument within one second of its entering RVO mode 22 Make a note of scale reading in grams 23 Note expected volume as identified on 80VCS set insert 24 Do not remove 80VCS set from instrument until one of following conclusions is determined e Instrument passes rate verification and calibration is not needed e Rate calibration number was changed and instrument now passes verification e Mechanism replacement is required 10 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check in and Configuration Continued Alternative Rate Accuracy Qualification Test Continued 25 Calculate gravimetric accuracy as follows Gravimetric Volume Accuracy Error Computation Vcollected volume in flask in grams Vexpected characterized volume printed on 80VCS set insert Step 1 A Vcollected Vexpected Step 3 B Ax 100 Step 3 Error round Error to nearest tenth of a percent B 100 A passing result is 0 043 26 If result is outside required range of 3 from expected volume perform one of following steps e If result is inside a range of 5 5 to 7 0 from expected volume perform rate calibration refer to Technical Service Manual Set rate calibration number to 0 0 before running rate test to determine a n
84. gs and cautions provide information needed to safely and effectively use the Alaris SE pump See Warnings and Cautions on page 73 A lt DANGER gt is an alert to an imminent hazard which could result in serious personal injury and or product damage if proper procedures are not followed A Wue is an alert to a potential hazard which could result in serious personal injury and or product damage if proper procedures are not followed A atel ie is an alert to a potential hazard which could result in minor personal injury and or product damage if proper procedures are not followed 2 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Unpacking Remove instrument from carton WARNING 2 IMPORTANT Plug instrument into an AC outlet a minimum Failure to properly charge the of 24 hours prior to use battery results in an instrument malfunction Biomedical personnel Maximum battery capacity as well as gauge accuracy is in the facility are responsible for reached after several charge discharge recharge cycles in unpacking the instrument and the refresh process CareFusion recommends that the ensuring that the battery is fully battery be fully charged discharged recharged using the charged before placing the refresh cycle before placing the instrument in use instrument in use 3 Perform regular inspections see Inspection Requirements on page 776 See Configurable Settings on pag
85. ifies that it is in fully closed position 2 Using both hands press top and bottom of AccuSlide flow regulator into instrument until it snaps into place a Verify that three gray fingers clamp arms on each side of pumping mechanism have engaged AccuSlide flow regulator b Let go of set A properly loaded set stays in instrument 3 Press firmly just below blue thumb clamp on AccuSlide flow regulator while fully closing latch to left After set installation verify that no fluid is flowing through the set s drip chamber to avoid free flow e If resistance is met while closing latch remove set verify that AccuSlide flow regulator is fully closed and then reinstall set CAUTION Before operating the instrument e Verify that thumb clamp has moved to open up position prior to starting infusion verify that the administration set is free from kinks and installed 4 Attach set to patients vascular access device correctly in the instrument 5 Verify flow from IV container after starting infusion User Manual Alaris SE Pump Rev2 X 17 Models 7100 7130 7200 7230 Getting Started Administration Set Information Administration Set Information Continued Remove Set 1 Place channel on hold WARNING 2 Open latch Even though the instrument automatically closes the AccuSlide flow regulator verify that the AccuSlide flow regulator is closed when the set is removed from the instrumen
86. ime Exceeded visual and audio prompts begin An additional two minute period may be initiated by pressing hold soft key or RUN HOLD key 2 To restart infusion while on hold press channel RUN HOLD key 1 If the flow sensor option is in use VTBI can be turned off by selecting VTBI pressing the CLEAR key and then pressing the ENTER key Or the primary VTBI can be deleted from the primary mode setup page see Configurable Options on page 92 20 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Primary Infusion Primary Infusion Continued Change Parameter During Infusion Continuous infusion parameters Rate or VTBI may be changed without pausing the infusion and VI may be cleared 1 Select applicable channel as necessary 2 Press soft key next to parameter to be edited Current value is highlighted 3 Perform one of following steps e To change rate or VTBI enter a new value e To reset VI to 0 0 mL press CLEAR or 0 zero key 4 To accept change press ENTER key KVO Mode When the primary VTBI reaches 0 0 mL the instrument automatically switches to the configured KVO keep vein open rate or remains at the current infusion rate whichever is less e Programmed infusion rate continues to be displayed in Main Display e KVO flashes in infusion status bar e KVO alert tone sounds may be silenced for two minutes using Silence key e VTBI 0 message flash
87. imit may be varied from 25 mmHg to the maximum configured pressure limit in 25 mmHg increments A default alarm level and a maximum pressure limit are set through the hospital configuration settings Set Alarm Limit Marker Pressing the 4 or P soft key changes the alarm limit by 25 mmHg in the corresponding direction It is advisable to select an alarm limit appropriate for the flow rate At lower flow rates the alarm limit should be set lower to shorten the time to alarm Automatic Baseline Calibration Used to Monitor Pressure The auto pressure baseline calibration remains in effect until the instrument is turned off the latch is opened the set is reloaded or the Set Pressure Baseline function is performed e The first activation of RUN HOLD for a new infusion automatically establishes a pressure baseline based on current system pressure An optimal baseline is maintained upon subsequent activations of RUN HOLD as follows 58 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Options Pressure Mode Continued Adjustable Pressure Alarm Continued Automatic Baseline Calibration Used to Monitor Pressure Continued o If current system pressure is same or higher than original baseline pressure baseline does not change o If current system pressure is less than original baseline system automatically resets to new
88. imum infusion pressure generated into a hard occlusion at 25 mL h is 11 6 3 9 psi Bolus Volume Released Monitoring Options Upon Correcting Downstream Occlusion Pressure Resistance and High mL Resistance 25 mmHg 600 mmHg 100 100 Threshold Settings 25 mmHg 600 mmHg Maximum 0 5 0 5 0 5 0 5 1 mL h Typical lt 0 1 0 3 lt 0 1 lt 0 1 Maximum 0 5 0 5 0 5 0 5 25 mL h Typical lt 0 1 0 3 lt 0 1 0 3 Testing performed using Model 72003 administration set at 68 8 F 20 4 C Environmental Conditions Operating Storage Atmospheric Pressure 700 to 1060 hPa 500 to 1060 hPa Relative humidity 20 to 90 5 to 95 Noncondensing Noncondensing 41 to 104 F 5 to 40 C 40 to 140 F 40 to 60 C Temperature Range Fluid Ingress Protection IPX1 Drip Proof User Manual Alaris SE Pump Rev2 X 95 Models 7100 7130 7200 7230 General Information Specifications Specifications Continued Flow Rate Range 0 1 to 600 0 mL h in 0 1 mL h increments secondary mode 0 1 to 999 9 mL h in 0 1 mL h increments all other modes Ground Current Leakage Electrical leakage current enclosure lt 100 microamperes Electrical leakage current patient lt 10 microamperes KVO Flow Range 0 1 to 20 0 mL h in 0 1 mL h increments Mode of Operation Continuous Power Requirements 100 240 V 50 60 HZ 72 VA MAX 3 wire grounded system Class 1 with Internal Power Source Rate Accuracy
89. in line detector before an air in line alarm sounds One of four different air in line detection settings can be selected 50 100 200 500 mcL Air in Line Accumulator Detects the presence of multiple air bubbles that are too small to be detected by a single bolus AIL detection limit The accumulator feature when enabled looks for 10 15 of the downstream fluid path to be air before giving an ACCUMULATED AIR IN LINE alarm The volume of air that trips the accumulated air detection alarm varies based on the current setting for a single air bolus Air in Line Reset This allows the clinician to respond to an air in line alarm assess its clinical significance and choose whether or not to continue infusion without removing air The reset feature allows only the current bubble to proceed without tripping an alarm Transition Tone secondary to primary Provides an audible tone when the secondary VTBI reaches zero to indicate the infusion has transitioned to a primary rate Volume If all audio volume levels are enabled the audio volume can be adjusted for alarms alerts and KVO tone to either High Medium or Low The audio volume indicator in the lower LCD display indicates the selected audio volume The instrument can be configured to enable only Medium and High or only High audio volume levels if desired Configuration Name Allows a 4 digit instrument ID label to appear in the lower LCD display User Manual Alaris SE Pump
90. infusion press RUN HOLD key 123 In Pressure Monitoring mode a trend graph displays monitored pressure over time Trend graphs of 15 minutes 1 hour 4 hours and 12 hours are available during normal operation when enabled through the hospital configuration settings Downstream Occlusions which occur in Pressure or Resistance modes are indicated by a tick mark I at the top of the trend screen View Graph 5 Select applicable channel as necessary Trend graph is not available while split screen is displayed Press OPTIONS key Press Pressure Trend soft key N Sd The pressure baseline calibration remains in effect until the instrument is turned off the latch is opened the set is reloaded or the set Pressure Baseline function is performed again Setting the manual baseline overrides the auto baseline until the instrument is turned off the latch is opened set is loaded or another manual baseline is set Setting a manual Pressure Baseline displays a horizontal real time bar graph and numeric pressure readings The vertical line on the pressure bar graph visually indicates the pressure alarm limit A B OPTIONS Oy 600 m gt m a H el a 12h PRESSURE now return clear time dd d User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Op
91. ion is not needed e Rate calibration number was changed and instrument now passes verification e Mechanism replacement is required 25 Calculate volume accuracy as follows Volumetric Volume Accuracy Error Computation Vcollected volume in burette in milliliters Vexpected characterized volume printed on 80VCS set insert Step 1 A Vcollected Vexpected Step 2 B Ax 100 Step 3 Error round Error to nearest tenth of a percent B 100 A passing result is 0 043 User Manual Alaris SE Pump Rev2 X 7 Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Rate Accuracy Qualification Test Continued 26 If result is outside required range of 3 from expected volume perform one of following steps e If result is inside a range of 5 5 to 7 0 from expected volume perform rate calibration refer to Technical Service Manual Set rate calibration number to 0 0 before running rate test to determine a new calibration number e If result is outside a range of 5 5 to 7 0 from expected volume return instrument to CareFusion for repair or replace mechanism 27 Set stopcock to drain fluid in burette to zero level in preparation for next test Alternative Rate Accuracy Qualification Test This procedure is to be used only when testing an instrument during a new instrument check in or when just received from the service dep
92. ion mode mcg microgram ug Un unit mcL microliter uL VI volume infused mEq milliequivalent VTBI volume to be infused mg milligram User Manual Alaris SE Pump Rev2 X 99 Models 7100 7130 7200 7230 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual administration sets cause short term fluctuations in rate accuracy The following graphs show typical performance of the system for both Pressure and Resistance modes in two ways e Accuracy during various time periods over which fluid delivery is measured trumpet curves e Delay in onset of fluid flow when infusion commences start up curves Product operation is not affected by the selection of Resistance or High Resistance at 0 1 mL h 1 0 mL h and 25 mL h therefore High Resistance graphs are not included Trumpet curves are named for their characteristic shape They display discrete accuracy data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows might
93. ir in line sensors are thoroughly cleaned Dose Out of Range Calculated dose is outside allowable range Verify and reenter settings Entry Invalid Instrument Self check is Due Please Eject the Set Invalid Entry Rate Out of Range An invalid value was entered during programming Instrument or channel did not perform self check within programmed interval Instrument calculated a rate less than 0 1 mL h Press CLEAR key or 0 key to clear entry Enter appropriate value If set is loaded Eject set wait five seconds and then reload set If no set is loaded Load set wait one minute and then eject set Wait five seconds and then reload set Verify and reenter settings Latch Open Latch is open prior to starting an infusion Close latch fully to left Maintenance Reminder Periodic maintenance interval elapsed Maintenance Reminder feature is on Notify Biomedical Engineering department If desired press continue soft key to temporarily bypass reminder New Baseline Set A new Manual Pressure Baseline was successfully set Manual Pressure Baseline feature is on Baseline remains set until a new manual baseline is set instrument is turned off or latch is opened Occlusion Downstream A very high pressure exists in fluid line while baseline is being set Pressure Baseline feature is on Remove source of high pressure and repeat setting of pressur
94. ir is expelled from set Close AccuSlide flow regulator clamp Place flask in middle of scale Load set into instrument and close latch Verify no fluid flow or drops falling in drip chamber Plug instrument into a properly grounded AC outlet Place output of set so it drips into flask Do not let set rest on flask Press POWER key to turn channel on Set primary infusion rate to 400 mL h Set VTBI to 20 mL Ensure that instument both channels if dual channel is set to Pressure mode 1 Press RUN HOLD key to start primary infusion Infuse until tubing is fully primed approximately one minute Press RUN HOLD key to stop infusion 1 The factory default for the Monitoring Options mode is Pressure User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Alternative Rate Accuracy Qualification Test Continued 16 Adjust height of instrument and or fluid container to attain a head height of 30 1 inches 76 2 12 5 centimeters between middle of pumping mechanism and fluid level in one of following sources e bag or vented bottle vent closed on administration set e drip chamber unvented bottle with vent open on administration set 17 Zero reading on scale 18 Verify that primary infusion rate is 400 mL h 19 Reset VTBI to 40 mL and clear volume infused 20 Press RUN HOLD key to start primary in
95. l to the maximum pressure limit Pressure Limit Maximum In Adjustable Pressure monitoring mode the pressure alarm limit may be varied from 25 mmHg to this maximum configured pressure limit in 25 mmHg increments A value that exceeds this pressure limit cannot be selected User Manual Alaris SE Pump Rev2 X 89 Models 7100 7130 7200 7230 General Information Configurable Settings Configurable Settings Continued Definitions Continued Dynamic Monitoring Resistance Resistance monitoring eliminates the impact of patient elevation and flovv rate to provide the most direct assessment of patency It is designed to monitor IV line site resistance providing optimum sensitivity for most IV applications High resistance is designed to monitor IV line site resistance with optimum sensitivity where higher resistance catheters are used Default Resistance Alert Default resistance alert level that is automatically set when the instrument is powered on The resistance alert marker can be adjusted up or down from this default setting as needed Resistance Alert Provides an early warning of increasing flow resistance When enabled the resistance alert marker can be set from 0 to 100 of scale in 5 increments Resistance Display must also be enabled To optimize the alert feature it is advisable to set the alert level 20 to 30 higher than the initial displayed resistance which should be read approximately two minutes after
96. lay of line pressure The pressure limit might be reduced if the pressure in the line is high or changing This results in the pressure limit being lowered from the selected setting If this occurs first try to remove or reduce the downstream pressure Following that try to reload the set wait 15 to 30 seconds and then perform a Set Pressure Baseline operation The pressure baseline might need to be set a second time after the pressure readings have stabilized Manually Set Pressure Baseline While Operating in Adjustable Pressure Mode For optimal results set the baseline 15 minutes after starting an infusion The pressure baseline can be optimized particularly at low flow rates less than 3 mL h by resetting the pressure baseline when the readings are negative Check periodically for negative readings for example when programming VTBI This allows the pressure baseline to calibrate based on current system pressure 1 Select applicable channel as necessary Pressure bar graph is not shown when split screen display is active 2 Press RUN HOLD key All infusions connected to channel being base lined must be on hold 3 Press OPTIONS key 60 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Options Pressure Mode Continued Pressure Baseline Continued Manually Set Pressure Baseline While Operating in Adjust
97. le as either a single or a dual channel pump The dual channel pump is a two channel device intended to deliver multiple infusions to a single patient The Alaris SE pump uses a wide variety of administration sets for the AccuSlide flow regulator The 72 Series administration sets are designed for use with the instruments as well as for gravity flow stand alone use The unique patented AccuSlide flow regulator has an integral flow control device that minimizes accidental free flow when the set is removed from the instrument and provides accurate rate control during gravity administration Qualified service personnel can configure many features of the instrument to meet specialized needs See Configurable Options on page 92 for a list of the configurable options and their default settings Refer to the Technical Service Manual for the procedure on how to set selected configuration parameters Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area User Manual Alaris SE Pump Rev2 X 1 Models 7100 7130 7200 7230 Getting Started Introduction Introduction Continued Administration Sets See Administration Set Information on page 14 Alarms Alerts Prompts See Alarms Alerts Prompts on page 108 Electromagnetic Environment See Regulations and Standards on page 119 Contraindications None known Warnings and Cautions VVarnin
98. lications create various levels of resistance to flow Monitoring mode options are available to meet each clinical need Select Monitoring Option Resistance designed to monitor IV line site resistance providing optimum sensitivity for most IV applications High Resistance designed to monitor IV line site resistance with optimum sensitivity where higher resistance catheters are used Adjustable Pressure designed to monitor IV line site pressure and provide user adjustable pressure alarm limits Used for Precision Flow mode or for high resistance systems such as infusion through transducers into dialysis systems and through highest resistance catheters Pressure designed to monitor IV line site pressure and alarm based on a fixed pressure limit A B OPTIONS ON sic 125 0 mL h VTBI 1000 0 mL ET we 50 Resistance LJ LJ A B OPTIONS o Rate 125 0 mL h s VTBI 1000 0 mL Viz 0 0 mL e 450 mmHg 4 E 1 Select applicable channel as necessary Bar graph and numeric displays are not available when split screen is displayed 2 Press OPTIONS key 3 Press Monitoring Options soft key aE OPTIONS o Resistance Trend 1 Monitoring Options e Dose Rate Calculator al Set Pressure Baseline return page m dd 1 Precision Flow In fixed and
99. lus feature must be on for downstream occlusion alerts not required for upstream occlusion alerts Check administration set for probable cause such as kinked tubing clogged filter Complete Entry Resistance Alert Additional Alerts ENTER was not pressed to accept a new value IV line resistance reached preset alert level Resistance Alert feature is on Press ENTER key to confirm entry or press CLEAR key twice to return to previous settings Note Channel operates as previously programmed until ENTER key is pressed Check downstream line and site Raise resistance alert level If appropriate Additional alerts provide notification of program completion and or transition to another mode Dose Complete Multi Dose mode Loading Dose Complete Multi Step Complete Secondary Complete Infusion in KVO or VTBI 0 112 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance Alarms Alerts Prompts Alarms Alerts Prompts Continued Prompt Air In Line Meaning Air detector detected air prior to starting infusion or is in poor contact with set Response Press continue soft key to allow infusion to continue An alarm occurs if air detector detects an air bubble larger than configured threshold Verify that set is loaded correctly Prime and reload set or remove air Reshape tubing to ensure optimum contact with sensor Ensure a
100. mercial or hospital environment If continued operation of the Alaris SE pump is required during power mains interruptions it is recommended that the Alaris SE pump be powered from an uninterruptible power supply or a battery The Alaris SE pump does employ an internal short duration battery 122 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Regulations and Standards Compliance Compliance Continued Electromagnetic Environment Continued Table 3 Electromagnetic Immunity Life Support Equipment IEC 60601 1 2 Compliance Electromagnetic Environment Emissions T SIISE Test Level Level 2 Guidance P c IEC 61000 4 6 3 Vrms 10 Vrms Portable and mobile RF communications Conducted RF 150 kHz 80 MHZ equipment should be used no closer to the IEC 61000 4 3 3V m 10 V m Alaris SE pump including cables than recommended separation distance da SO MRA oz calculated from the equation applicable to frequency of transmitter Recommended Separation Distance 12 VP V 12 VP 80 MHz 800 MHz E 12 d VP 80 MHz 2 5 GHz Es d recommended separation distance in meters m 4 P maximum output power rating of transmitter in watts W according to transmitter manufacturer Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than compliance level in each frequency range 91 Interference migh
101. mode ULV hr E ALS LLA LL hy Instrument ID Label Identifies selected configuration ownership location and so forth Battery Power Gauge Indicates approximate battery time remaining under current infusing conditions The instrument label and battery power gauge are always displayed even when the instrument is turned off however the battery power gauge does not represent the battery time remaining when the instrument is turned off To ensure a more accurate battery power gauge reading review the gauge approximately five minutes after starting an infusion The gauge updates for each program change during an infusion Battery run time might be affected by the operating mode rate monitoring options and back pressure User Manual Alaris SE Pump Rev2 X 85 Models 7100 7130 7200 7230 General Information Features and Displays Features and Displays Continued Displays and Soft Keys Continued Soft Keys Soft keys are the keys located on the left side and the bottom of Active soft keys the main LCD display They serve a variety of functions as EJ orrions indicated by the text in the display at the time O Rac 1050 mL A soft key is active if there is a tick mark I next to the key If VTB ED m A VI 0 0 mL there is no tick mark next to the key then it is not active and e cannot be selected Pressing an inactive Rey results in an el Limit 600 mmHG invalid
102. nce Reminder Pressure Options Manual Pressure Baseline Pressure Alarm Pressure Display Pressure Limit Initial Configuration Mode Def Alarm Pressure Limit Maximum 1 to 52 weeks On Off On Off Adjustable Fixed On Off 25 to 600 mmHg 600 mmHg 25 to 600 mmHg 52 weeks On On Adjustable On 600 mmHg 600 mmHg Pressure Sensor a Self Check Interval 1 to 52 weeks 12 weeks Resistance Options Default Resistance Alert Resistance Alert Resistance Display Resistance Pressure Setting O to 100 On Off On Off 1 to 600 mmHg 100 On On 600 mmHg Rate Maximum 0 1 to 999 9 mL h a This feature is configured in the Diagnostics Mode 999 9 mL h User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 93 General Information Specifications Specifications Administration Sets Use only administration sets for Alaris SE pump Alarms Accumulated Air In Line Key Stuck Air In Line Latch Open Battery Depleted No Upstream Flow Detected Channel Malfunction Occlusion Downstream Computer Link Failure Occlusion Upstream Flow Sensor Unplugged Primary Flow Detected During Secondary Hold Time Exceeded Set Out Instrument Malfunction Set Up Time Exceeded Battery Rechargeable nickel cadmium A single channel instrument operates for four hours nominal and a dual channel instrument operates for three hours nominal under following conditions e new
103. occur if the nurse call plug is not properly inserted 2 All alarms and some alerts activate the nurse call system The following alerts will not activate the nurse call system Checking Line Load Dose Complete Secondary Complete 3 Disconnecting the nurse call cable from the wall or turning off the instrument activates the nurse call system Disconnecting the nurse call cable from the instrument will not activate the nurse call system 70 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Setup and Operation RS 2323 Computer Link Nurse Call 7130 7230 Only Continued If an Alarm Occurs 1 Determine cause and appropriate corrective action see Alarms Alerts Prompts on page 108 2 Reset nurse call system as required RS 2323 Computer Link The optional Computer Link feature allows a hospital facility WARNING computer to interact with the instrument The computer cannot Use of any accessory or cable start or stop the instrument set the rate or make any change in other than those specified might status The feature may be enabled or disabled by qualified esitin ic Gacedem ecion Or personnel in the instrument configuration settings If the decreased Alaris SE pump feature is enabled On the user may select Monitor to allow que immunity the computer to receive information from the instrument or Off I When Off is selected the computer cannot communicate with The protective cover over
104. omatically resumes normal epn operating conditions excluding High Resistance Monitoring a 00 Resistance mode J T Pressure measurements initiate the Checking Line period when the pressure exceeds the configured limit If the pressure falls to less than one third of the configured limit within 40 seconds normal flow resumes If the condition is not cleared the OCCLUSION DOWNSTREAM alarm occurs and infusion stops until manually restarted This feature can be configured through the hospital configuration settings to allow from 1 to 9 Checking Line restarts After the programmed number of restarts has occurred or the 40 second Checking Line period has been exceeded the channel immediately alarms OCCLUSION DOWNSTREAM when resistance or pressure conditions indicate an occlusion User Manual Alaris SE Pump Rev2 X 53 Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Resistance Mode Monitoring Options Resistance Mode Continued Resistance Alert The Resistance Alert provides an early warning of increasing flow resistance The Resistance Alert marker can be set from 0 to 100 of scale in 5 increments This feature can be enabled or disabled and a power on default alert level is set through the hospital configuration settings To optimize the alert feature it is advisable to set the alert level 20 30 higher than the initial displayed resistance Read the resistance approximately two minutes
105. ompanying documentation Audio volume Approximate battery time remaining under current infusing conditions Battery gauge does not represent battery time remaining when instrument is turned off Conformit Europ enne CE Marking notified body 0086 British Standards Institution Electrical shock protection rating Type CF Type CF defibrillation proof equipment Explosion risk if used in presence of flammable anesthetics Flow sensor receptacle optional channel A Flow sensor receptacle optional channel B Infusing indicator Indicates degree of protection liquid ingress Manufacturing Date Number adjacent to symbol indicates month and year of manufacture Nurse Call optional for 7130 7230 Consult operating instructions User Manual Alaris SE Pump Rev2 X 97 Models 7100 7130 7200 7230 General Information Symbols and Terms Symbols and Terms Continued 0 Panel lock af Green instrument plugged into AC power and battery being charged Flashing amber instrument running on battery power and battery being depleted RS 232 RS 232 connector ROn Caution Federal United States law restricts this device to sale by or on the order of a y physician Silence mode A B Split screen dual channel instrument only Transition Tone A brief tone during transition from one mode to another Canadian and United States Certification Mark Products bearing this mark have
106. ondary IMUSION duts lec tr rt 22 SGUD A o demandes escena cent el escenes tues E er csc ee 23 IS IO sara tallado ladilla 24 Change Parameters During Infusion ccoocccccnoccncconccconononononnnnononononononannonanonanonnnnonanonaninaninanns 25 Drug Specific Dose Rate Calculator DRC coocccoccoconoconncocnoconoconocanononnonanonanonannonnnonnnnnnnnnnnonnnonaninnanes 27 TOGKAMMN anar Id ind 28 EO CCE AA E E O we ern Nr Wee en Cea re me ene rein T N 32 PROOTON ao ao 32 SUSI OS urllist tro 34 Fe FOG AIM OPONE E CO 50 O re ania ms ecm nna Sines nliretate 34 Resume an Interrupted MuIti DOSe cooocconcconooncconcconconcconononononoononononnnnnnonnnonnnonnennncnnnnanenons 38 Quit Multi DOS Eric is es ei eo eet 40 MES e td e iu 40 ROO ari iia 40 View Steps or Make Changes ae iamcaioctesteacetdis meta ase acean ota iii Aa 44 Resume an Interrupted Infusion cccoonococnconnoconcconcconncnnnocanonnnnonnnonnnonnnnonnnonanonanonannennnonanenaninnons 46 QUIEUMO Ps St ee ed tomata 47 User Manual Alaris SE Pump Rev2 X jii Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options GENn Cra este nt id 50 SEICCEMOR OAC ODOM i i tt le ona 50 Monitoring Options Resistance Mode occoccccccccccccncnoncnononononncnnnonononononnnnonnnnnnnonanonannnnnnnnnnonanonaninaninnnns 52 Detection of Downstream OCCIUSIONS oocccocccocccnccncocnconnonononncnnnnnonnnonnnnnnrnnnnnnnnnnnnnnnnnnnnaninnnnnnnnen
107. onnect the ground screw for the battery cover on the chassis Refer to the test resistance probe to the pressure equipment s operation manual for the proper setup and transducer measurement technique Resistance must be lt 0 100 Instrument Configuration Instrument configuration is set by qualified personnel in the Configuration and Diagnostics modes Plug the instrument into an AC outlet during storage to ensure that the battery is fully charged when needed The AC indicator light is green when the instrument is plugged in Close the latch es when the instrument is not in use Administration Set Information The Alaris SE pump uses a wide variety of AccuSlide flow regulator administration sets The sets dedicated for use with the Alaris SE pump are designed for use with the instruments as well as for gravity flow stand alone use The unique patented AccuSlide flow regulator has an integral flow control device that minimizes the risk of unintended flow when the set is removed from the instrument and provides accurate rate control during gravity administration 4 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Administration Set Information Administration Set Information Continued General Continued e For specific administration set instructions refer to directions for use provided with set e Use aseptic technique when handling sets and syringes e Administra
108. ot center This test is to verify that damage or changes to the instrument did not occur during shipment and handling Due to the dynamic monitoring feature the rate is varied during operation For this reason CareFusion does not recommend using automatic testers to check rate accuracy Generally these devices collect small samples and might cause the results to be incorrect even though the instrument is accurate Do not use the Model 80VCS Calibration Set for more than 30 rate verification runs 15 rate calibration number changes Keep track of the number of times the set is used by recording each use on the 80VCS insert or on a separate record The test setup is the same as for the Rate Accuracy Qualification Test with the following exceptions e Burette and equipment stand are replaced with a digital scale Acculab Vic 212 or equivalent and 50 mL or 100 mL flask plastic or glass e Three way stopcock and used fluid receptacle are not needed User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Alternative Rate Accuracy Qualification Test Continued 1 2 E O OU EE 11 12 13 14 15 Fill solution container with clean tap water Close AccuSlide flow regulator clamp on 80VCS set and then insert spike into solution container Open AccuSlide flow regulator clamp and prime set Ensure that all a
109. played e Weight perform one of following steps o If weight entry in kg kilograms is desired press ok soft key to advance to programming page o If weight entry in Ib pounds is desired press FX soft key and then press ENTER key Press ok soft key to advance to programming page Patient weight in pounds is used to automatically calculate dose per kilogram per time 3 Enter parameters as needed als OPTIONS Dose field is highlighted for first entry but soft keys can be o Rate mL h pressed to highlight another parameter to be entered prior Dose mg kg h to a dose entry To automatically calculate dose instead of CON mg mL ga Wi kg rate press rate soft key and enter a rate value When all el entries have been completed dose or rate as applicable is automatically calculated 4 0 6 4 Verify that all parameters are correct and press ok soft key 5 Enter a VTBI value and then press ENTER key User Manual Alaris SE Pump Rev2 X 31 Models 7100 7130 7200 7230 Programming Loading Dose Drug Specific Dose Rate Calculator DRC Continued Program Continued Drug Name Not Listed Continued 6 Ifthere is a VI value that needs to be cleared press CLEAR key or press 0 zero key and then press ENTER key 7 To continue programming press ok soft key 8 Verify that all parameters are correct and
110. ps see Start Up on page 67 e Primary setup page is displayed e Primary infusion rate is highlighted 2 Perform one of following steps e If current primary infusion rate is appropriate press ENTER key e Enter new infusion rate and press ENTER key VTBI is highlighted EZA Prior to initiating a RUN HOLD verify that all displayed programming parameters are correct A B OPTIONS O 1VTBI ef e Oy Rate El mL h 0 0 mL 0 0 mL 24 y a A 6 6 o User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Primary Infusion Primary Infusion Continued 3 Perform one of following steps ale orrovs e If current primary VTBI is appropriate press ENTER OD sie 100 0 mL h key 1 Ga vIB Hm ef 0 0 mL e Enter new infusion rate and press ENTER key ol VI is highlighted Taa dius p LA 4 Ifthere is a VI value that needs to be cleared press CLEAR key or press 0 zero key and then press ENTER key 5 Verify that all parameters are correct and press run soft key or RUN HOLD key to start infusion 6 To briefly view current profile from RUN HOLD page or during a running infusion press M soft key Pause and Restart Infusion 1 An infusion may be paused temporarily by pressing RUN HOLD key Rate LED flashes while infusion is on hold e After two minutes Hold T
111. r service DIR 10000149477 2006 2011 CareFusion Corporation or one of its subsidiaries All rights reserved 0086 II User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Table of Contents Getting Started INTFOQUCHION sarria A A A De a Ne 1 UD ACH cad lion oia 3 CHECKIN ANC OMMOUPAIOMN atletes eo ae ies 3 Rate Accuracy Qualification Test a il 4 Alternative Rate Accuracy Qualification Test ooncconcccocncocnnoncncncnnncnncononnnnnnnnnnononanonanononnnncnnnnns 8 Set Sensor Check Pressure Calibration Verification occcooccconncccncocnconnnonnnoncnonnnonanonanonnnnnnonos 11 FUNCIONA MES Crta dle iio 12 o AAA A A O Da ee ee ee 13 Ground Current Leakage ME la 14 GhOUNGMRESISIANGO NOS P peses eres empedrat a 14 IS UE EC ONTIGUIATION oi sito 14 OAIE gener ete gee tios nedar Gel ates ioen triats este CO ara dd tat Se ee ee eee 14 AMISTOSO Ei ces 14 tc A Lee camisetes o A e A tat ee 14 omansite Needie Rree Vale uni li 15 Prepare Solution Container and Set occcoccccccoconoconncucnncanonononononononnnnonnnonannnnnnnnnnennnonnnnnnnnnaninnnnenens 16 Teo 72 6 New A A ee 17 FS NOW Ch Oly ae tetas sete e E edit ente seated aie decanter sees ense cuit lot deien cere gen 18 Change Sol on COMA la alta cales 18 Programming AM a ES 19 Pause and Restart INTUSION estira sitat este ont mels tetas 20 Change Parameter During Infusion esse sitats A tios si can 21 KYO MOUGN a 21 Clear Volume INIUSEd cui 22 Sec
112. rants that e Each new Alaris SE pump is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by CareFusion to the original purchaser e The battery and each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by CareFusion to the original purchaser If any product requires service during the applicable warranty period the purchaser should communicate directly with CareFusion to determine the appropriate repair facility Except as provided otherwise in this warranty repair or replacement will be carried out at CareFusion s expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to the repair facility shall be at purchaser s risk In no event shall CareFusion be liable for any incidental indirect or consequential damages in connection with the purchase or use of any Alaris SE pump product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and CareFusion shall not be responsible for any loss or damage arising in connection with the purchase or use of any Alaris SE pump product which has been e repaired by anyone other than an authorized Care
113. ress ok soft key al OPTIONS O e All trend data will be cleared k el el return aus oe o All data is cleared from graphs A B OPTIONS QS 100 A el el 12h RESISTANCE now return clear time 1 El El El oe Return to Normal Operating Screen Press return soft key Normal operating screen appears The following events also turn off trend graph e Pressing RUN HOLD key e An alarm e Dual channel instrument o Pressing split screen key a 5 o Replaced with a split screen display after one minute if both channels are infusing 56 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Dynamic Monitoring System Monitoring Options Pressure Mode Monitoring Options Pressure Mode Downstream Occlusion Detection When using the Adjustable Pressure monitoring mode a pressure alarm limit may be varied from 25 mmHg to the maximum configured pressure limit in 25 mmHg increments When measured pressure exceeds this level an OCCLUSION DOWNSTREAM condition occurs When a Downstream Occlusion is detected one of following responses occurs e If Auto Restart Plus feature is on a Checking Line message appears along with an audible tone see Auto Restart Plus Feature for further details e f Auto Restart Plus feature is off an OCCLUSION Caral OPTI
114. rms The tubing may be reshaped to ensure U optimum contact with the sensors Periodically clean the air in line detector to ensure a clear signal can be received see a Cleaning on page 116 0 b Air is detected by an emitter air in line arm which rotates into position as the latch is closed A receiver air in line detector opposite the arm and just below the pumping mechanism sends the air in line information to the main processor Air in Line Detector y Air in Line Arm User Manual Alaris SE Pump Rev2 X 107 Models 7100 7130 7200 7230 Troubleshooting and Maintenance Air Bubble Detection Air in Line Assembly Continued Qualified biomedical personnel may configure one of four possible sensitivity levels The instrument is also configurable to permit the operator to clear reset any air registered in the instruments memory Air Bubble Detection To place channel on hold press hold soft key N Remove air per hospital protocol 1 2 To resume infusion reinstall set and then press RUN HOLD key e If air volume is clinically insignificant press reset soft key or RUN HOLD key followed by run soft key or RUN HOLD Rey to resume infusion e Subsequent air bubbles trigger alarm Alarms Alerts Prompts Use this section in conjunction with the appropriate clinical practice of hospital procedure When using the dual channel instrument some messages also display Ch
115. s routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instruments repairable components Maintenance procedures are intended to be performed only by qualified personnel Artifacts It is normal for an infusion device to produce nonhazardous currents when infusing electrolytes These currents vary proportional to the infusion device flow rate When an ECG monitoring system is not functioning under optimal conditions these currents might appear as artifacts simulating actual ECG readings To determine if ECG abnormalities are caused by patient condition or the ECG equipment place the Alaris SE pump on hold If the ECG readings become normal the ECG equipment requires attention Proper setup of the ECG equipment should eliminate these artifacts Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance Air in Line Assembly The Air in Line Detection System provides clinicians the ability to detect inappropriate amounts of air in the IV line The instrument is configurable to allow single bubble and accumulated air detection Accumulated air detection is based on measurement of the average percentage produced by small air bubbles passing the detector Ensure that the tubing is properly inserted into the air detector to avoid false ala
116. s used exceeds the applicable RF compliance level the Alaris SE pump should be observed to verify normal operation If abnormal performance is observed additional measures might be necessary such as reorienting or relocating the Alaris SE pump Over the frequency range of 150 kHz to 80 MHz field strengths should be less than V V m 124 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Regulations and Standards Compliance Compliance Continued Electromagnetic Environment Continued Table 4 Recommended Separation Distances Reduce the potential for electromagnetic interference by maintaining a minimum distance betvveen portable and mobile RF communications equipment transmitters and the Alaris SE pump as recommended in this table based on the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed in this table the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts VV based on the transmitter manufacturer Rated Maximum Separation Distance Based on Transmitter Frequency m 2 0 0 Output Power of Transmitter W 150 kHz 80 MHz Outside ISM Bands 3 5 d VP 150 kHz 80 MHz Inside ISM Bands d 12 d VP 80 MHz 800 MHz 800 MHz 2 5
117. se Immediately A displayed time of 0 hours 0 minutes identifies that first dose starts immediately after programming 1 To approve and advance to main hold page press ok soft ATs OPTIONS sey Ou 0 min e Until First Dose a VI 0 0 mL el ok 656 6 OPTIONS ON Raie 250 0 mLh oe 2 To start infusion press RUN HOLD key or run soft key 3 VTBI 100 0 mL e VI 0 0 mL F menu run 4 4 Delay Start of First Dose Enter number of hours until first dose and press ENTER Rey AIB OPTIONS 2 Enter number of minutes 0 to 59 until first dose and press nd ENTER key M 3h ges a min aj Until First Dose el VI 0 0 mL el menu start timer 4 36 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Multi Dose Multi Dose Continued Program Continued Delay Start of First Dose Continued 3 To advance to timer hold page press start timer soft key ABB OPTIONS As Ga 12 min lt y Until First Dose e VIz 0 0 mL el menu start timer 5 4 e Hourglass icon flashes to indicate timer is counting ale OPTIONS down to start of dose Or e Dose automatically starts its infusion when timer 12 min aq reaches 0 hours 0 minut
118. sion to automatically set pressure baseline Pressure Limit Must Be Less Than or Equal to XXX mmHg XXX represents configured maximum pressure Attempt was made to increase pressure alarm limit to a level higher than configured maximum pressure Choose a pressure alarm limit that is less than or equal to configured maximum pressure Pressure Unstable Cannot Set Baseline Excessive variation in pressure due to motion flow from other instruments or blood pressure prevents accurate setting of pressure baseline Pressure Baseline feature is on Reduce or temporarily remove sources of variation while performing manual baseline setting operation User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance Alarms Alerts Prompts Alarms Alerts Prompts Continued Prompts Continued Program Lost Re Enter Setting Meaning A memory or power failure was detected Existing operating parameters were erased Response Press continue soft key and reenter all infusion settings Configurable options are not affected Rate Out of Range Instrument has calculated a rate less than 0 1 mL h Verify and reenter settings Set Must Be Loaded Flow Regulator segment is not loaded in selected channel during a manual pressure baseline setting operation Pressure Baseline feature is on Load Flow Regulator segment in selected channel Repe
119. ssage appears e Audio alarm sounds and infusion stops e In certain conditions upstream alarm system might briefly pause instrument and present Checking Line message for 10 seconds to confirm or rule out presence of an occlusion If occlusion condition is determined not to exist flow resumes and no alarm is produced User Manual Alaris SE Pump Rev2 X 65 Models 7100 7130 7200 7230 Dynamic Monitoring System Upstream Occlusions Detection THIS PAGE INTENTIONALLY LEFT BLANK 66 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Setup and Operation Secure to Pole The uniquely designed pole clamp adapts to a vvide variety Of WARNING surfaces such as poles and bed rails to provide greater To ensure proper occlusion versatility and to simplify transports 1 detection do not operate the It features instrument tilted back more than 45 degrees from the upright position e 360 degrees rotation in 90 degree increments e ergonomically designed knob e accommodates diameters from 15 to 35 millimeters When using multiple instruments use care to evenly distribute the instruments to ensure stability Change Pole Clamp Orientation 1 Press and hold rotation lever lt lt i j W Ne D Reposition clamp ad Release lever at desired position
120. ssure Calibration section or contact CareFusion Technical Support for assistance Functional Test 1 Turn instrument on without set installed Verify that it beeps and that red alarm light flashes but does not stay lit 2 Set infusion rate to 460 mL h and VTBI to 100 mL 3 With latch closed press RUN HOLD key and rate and VTBI 0 to cause Set Out and Air In Line messages 4 Open latch 5 Install primed administration set with latch open 6 Verify that instrument displays Air In Line and Latch Open messages 7 Close latch and verify that display returns to setup page 8 Perform Upstream Occlusion Test as follows a Verify that infusion rate is set to 460 mL h b With instrument on hold or at start up verify that primary VTBI is set to greater than 100 mL Press RUN HOLD key to begin infusion Clamp off IV line just above instrument about two inches to simulate an upstream occlusion e Verify that instrument stops running alarms and displays OCCLUSION UPSTREAM within 60 seconds 12 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Check In and Configuration Check In and Configuration Continued Functional Test Continued f h Press RUN HOLD key to silence alarm and put instrument on hold Release or open clamp and remove from tubing Press RUN HOLD key to resume infusion Alarm should not reoccur Perform Downstream Occlusion Test
121. stance Mode Trumpet Curve at 25 mL h initial Flow Rate Error 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 25 mL h 48 hr Flow Rate Error 90 O o o o o A o 15 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Start up at 999 9 mL h initial 0 20 40 60 80 100 120 Time min Resistance Mode Trumpet Curve at 999 9 mL h initial Flow Rate Error 90 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 999 9 mL h 24 hr Flow Rate Error 99 0 5 10 15 20 25 30 Observation Interval min User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 105 General Information Trumpet and Start Up Curves Trumpet and Start Up Curves Continued High Resistance Mode High Resistance Mode Start up at 999 9 mL h initial 2000 1800 1600 1400 1200 1000 E 800 0 20 40 60 80 100 120 Time min High Resistance Mode Trumpet Curve at 999 9 mL h initial e o al al Flow Rate Error O o Es o 15 0 5 10 15 20 25 30 Observation Interval min High Resistance Mode Trumpet Curve at 999 9 mL h 24 hr Flow Rate Error 0 5 10 15 20 25 30 Observation Interval min 106 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Troubleshooting and Maintenance The Alaris SE pump Technical Service Manual is available from CareFusion It include
122. t to prevent unintended flow CAUTION Do not attempt to force the set from the instrument Send the instrument to qualified service AccuSlide flow regulator automatically closes to prevent accidental unintended flow 3 Press latch fully to right Set is ejected from instrument personnel Change Solution Container 1 Place channel on hold 2 Remove empty solution container 3 Spike new container 4 Ensure that drip chamber is filled to full 18 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 References throughout this procedure to specific drugs and drug doses are for illustration purposes only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages IMPORTANT e Prior to starting or restarting an infusion verify that the prescribed therapy is displayed e Listen for audible tones e Observe the flow rate in the IV tubing drip chamber to verify the expected flow Displays See Features and Displays on page 81 for a description of the displays and soft keys and instructions on how to enter programming values Powering on and off See Power On and Offon page 68 for instructions on how to turn the instrument on and off Maintenance Reminder See Respond to Maintenance Reminder on page 70 for instructions on how to respond to a Maintenance Reminder message Primary Infusion 1 Perform Start Up ste
123. t occur in the vicinity of equipment marked with the following symbol 4 1 User Manual Alaris SE Pump Rev2 X 123 Models 7100 7130 7200 7230 Regulations and Standards Compliance Compliance Continued Electromagnetic Environment Continued Table 3 Continued Electromagnetic Immunity Life Support Equipment Compliance levels raised by IEC 60601 2 24 At 80 MHz and 800 MHz the higher frequency range applies These guidelines might not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment might cause interference if inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and mobile radios amateur radio AM FM radio broadcast TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Alaris SE pump i
124. teps have been entered and accepted press AB OPTIONS done soft key O EDS Review page displays three sequence steps at a time Qi Rate mL h el VTBI mL ee Time h min el menu done dd 4 7 To approve and advance through review pages press ok ale de soft key O SN RATE VTBI TIME Gea i 50 5 0 0h12m 2 10 0 25 0 0h30m e 3 100 0 100 0 1h Om Y menu ok dd 4 8 To clear VI if desired press CLEAR or 0 zero key and 18 OPTIONS then press ENTER key QS STEP TOTALS 3 VTBI 130 0 mL g Times 1 h 42 min C VI E mL el menu OR d 6 9 To accept STEP TOTALS page press ok soft key ma oPrions Oy STEP TOTALS 3 VTBI 130 0 mL g Time 1 h 42 min el VI 0 0mL Y menu ok dd 4 42 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Programming Multi Step Multi Step Continued Program Continued Program Rate and Volume Continued 10 To start multi step infusion press run soft key or RUN als OPTIONS POED KC A Rate 25 0 mL h VTBi 5 0 mL of Vi 0 0 mL a 49 menu setup run 4 Program Volume and Time 1 Press Volume and Time soft key 2 Enter a VTBI and press ENTER key 3 Enter hours and press ENTER key Tal OPTIONS ON ster 1 Rate mL h ayi VTBI 5 0 mL el Time Eh min menu
125. tion Set Information Administration Set Information Continued Prepare Solution Container and Set 1 Prepare the primary solution container in accordance with WARNING the manufacturer s directions for use e Use only sets dedicated for use 2 Slide AccuSlide flow regulator thumb clamp down until an with the Alaris SE pump The audible click verifies that it is in fully closed position use of any other set might cause AccuSlide flow regulator improper instrument operation S resulting in an inaccurate fluid T delivery or other potential hazard gi N e Discard if packaging is not intact or protector caps are unattached Thumb Clamp Naz 3 Spike solution container 4 Fill drip chamber to full 5 If container requires venting open vent cap on spike 6 Invert AccuSlide flow regulator 7 Slide AccuSlide flow regulator thumb clamp to open Slide up to open position to slowly prime set for priming 8 Close AccuSlide flow regulator clamp when priming is complete as in Step 2 Verify that no fluid is flowing 9 If desired a gravity flow rate may be adjusted with AccuSlide flow regulator thumb clamp Slide down to close for loading 16 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 Getting Started Administration Set Information Administration Set Information Continued 1 Slide AccuSlide flow regulator thumb clamp down until an audible click ver
126. tion sets are supplied with a sterile and non pyrogenic fluid path for one time use Do not re sterilize or re use e For administration set replacement interval refer to facility protocol and or government standards such as CDC guidelines in the United States and see SmartSite Needle Free Valve on page 15 e Discard administration set per facility protocol e For IV push medication put instrument on hold and occlude tubing above injection port during administration e Flush port s per facility protocol e Place a sterile replacement cap on open end of tubing connector when not in use Discard tubing when integrity has been compromised SmartSite Needle Free Valve The SmartSite needle free valve is designed to permit injection and aspiration of fluids without the use of needles 1 Use proper hand hygiene procedures Wash hands with conventional antiseptic containing soap and water or disinfect with waterless alcohol based gels or foams 2 Prepare SmartSite needle free valve e Always swab top of valve port prior to every access with sterile 70 isopropyl alcohol wipe and allow to dry For multiple syringes swab prior to each syringe access e Replace every 72 hours or 100 activations whichever comes first Exception For infusions of blood blood products or lipid emulsions replace every 24 hours User Manual Alaris SE Pump Rev2 X 15 Models 7100 7130 7200 7230 Getting Started Administra
127. tions Pressure Mode Continued Pressure Trend Graphs Continued View Graph Continued 4 To change graph time frame press time soft key e A solid horizontal line represents current pressure alarm limit level e Gaps in graph might indicate noninfusing conditions such as turned off on hold in alarm e If channel has been placed in Resistance Monitoring mode for some portion of a trend graph window pressure data is not available and zero values are plotted e Atick mark I at top of graph indicates an occlusion ATB options 600 I i 12h PRESSURE now return clear time 6 4 Les Clear Graph 1 To clear graphed data press clear soft key 2 Press ok soft key NE ions N oe All trend data ee will be cleared ei return ok EA All data is cleared from graphs AJB OPTIONS Oy 600 o gt H o aed 12h PRESSURE now return clear time 6 4 User Manual Alaris SE Pump Rev2 X 63 Models 7100 7130 7200 7230 Dynamic Monitoring System Upstream Occlusions Detection Monitoring Options Pressure Mode Continued Pressure Trend Graphs Continued Return to Normal Operating Screen Press return soft key Normal operating screen appears Following events also turn off trend graph e Pressing RUN HOLD key e An alarm
128. to next page press page soft Rey Press Computer Link soft key Press Off soft key Press ok soft key gt Pe e N Disconnect RS 232 cable from RS 232 port on instrument rear panel 2 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Warnings and Cautions dl DANGER amp Explosion risk if used in the presence of flammable anesthetic agents or combustible vapors A AA MN e The Alaris SE pump is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected It is a positive displacement delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice including resistances to flow imposed by small gauge catheters filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions e Do not port the Alaris SE pump with a gravity flow infusion system The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site can impede the flow of common gravity only systems affecting their performance Hospital facility personnel must ensure the performance of the common IV site is satisfactory under these circumstances e Each time the Alaris SE pump is turned on verify and or set the monitoring mo
129. ument might not be operating with the desired occlusion detection parameters CAUTION e Appearance of lines and or dots that remain on constantly when the instrument is powered on might indicate improper functioning of the Main Display Although the instrument is functioning return it to qualified service personnel e Inspect LCD for anomalies improperly lit or unlit pixels User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Setup and Operation Start Up Start Up Continued Tamper Resist Panel Lock Feature The panel lock feature helps prevent unauthorized changes to the instrument settings including turning the instrument off The panel lock feature must be set to ON in the hospital configuration settings To make changes or respond to an alarm the panel lock must be turned off The panel lock key 60 is located behind the handle The panel lock feature is always off when the instrument is powered on because it must be off to power down the instrument e To turn panel lock feature on press and hold g until appears in lower display a a af dm w 0 A O o vg Panel Locked appears in Main LCD Display if any o fel Cornons other key is pressed ON Rate 125 0 muh o Dual channel instruments When panel lock feature is 0 1 VTBI 1000 0 mL on channel select and split screen keys can be used to o V
130. ury to the patient e Itis strongly recommended that the source container administration set and Alaris SE pump used for epidural drug delivery be clearly differentiated from those used for other types of administration User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 5 General Information VVarnings and Cautions Warnings and Cautions Continued Epidural Administration Continued WARNING MA e The Alaris SE pump can be used for epidural administration of anesthetic and analgesic drugs This application is appropriate only when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use Use only sets dedicated for use with the Alaris SE pump without a Y connector or injection port for epidural infusions o Epidural administration of anesthetic drugs Use indwelling catheters specifically indicated for short term 96 hours or less anesthetic epidural drug delivery o Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery Electromagnetic Compatibility e Do not use the Alaris SE pump near Magnetic Resonances Imaging MRI equipment including Stereotaxis technology e Do not use the Alaris SE pump near Therapeutic Radiation equipment such as Linear Accelerators e Use of any accessory transducer or cabl
131. ys displayed even when the instrument is turned off however the battery gauge does not represent the battery time remaining when the instrument is turned off Battery Recharge The battery recharges whenever the instrument is plugged into an AC outlet The battery can be replaced when charging capacity gets too low All batteries gradually lose their capacity to hold a charge over time and use To maintain optimal battery performance ensure that the instrument is connected to AC power whenever possible including when it is powered off or stored Battery Replacement and Disposal Battery replacement should be performed by qualified service CAUTION personnel while the instrument is not in use Use only CareFusion batteries e Do not open incinerate or short circuit the battery e Worn out batteries must be properly disposed of according to facility protocol 78 User Manual Alaris SE Pump Rev2 X Models 7100 7130 7200 7230 General Information Flow Sensor If the flow sensor option is in use VTBI can be turned off by selecting VTBI pressing the CLEAR key and then pressing the ENTER key Or primary VTBI can be deleted from the primary mode setup page see Configurable Options on page 92 The optional flow sensor notifies users of empty containers and or upstream occlusions A handle cap accessory is available for storing the flow sensor when not in use The flow sensor is not used for the first 25 mL d

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