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Directions for Use

1. M MY 21 LE Monitoring Options R 22 SmartSite Needle Free System Instructions eere eee eene enses en seen sensns tasses stas ta seta sinas en season seas ea sesta sss soa sno 26 Alarms Alerts and Prompts s cascssscescsecseconssncesostocsssoeuscsossseesecessacssveouecevesossonseveasecsGnoossseestencuesenoessnteedeeoseseuoeeseteaseeceseenses 27 LEE Ed S 27 AE E a a E E E A A E A E 28 LEMB Cinco 29 AU ciedducetete MM asea 31 Flow Sensor Operation optional eere eee eene eee eene eene anna in ea a 32 E e TEE EE 33 Configured Options Record 35 SPECIMCALI TC 36 Maintenante 38 Routine Maintenance Procedures ssesssssosseessososesossessoesosessssossessosscsesesosssossosssososssoesosssssoesesesossessoesosssossssssssosess 38 LEE Fil ASPelCIDI M 38 ME QS gl 38 Clearing and Storage 39 LMMPIDDILIe RR 39 RS232 Computer LINK dcc 40 rluPIsuiexdlM M 41 LEES Pressure MOE Ie
2. 42 XE E E E 44 High Resistance Mode e H M 45 ET ER en E 46 Uic TE E 47 1000DF00479 Issue 2 1 50 Introduction This document provides directions for use for the Alaris SE pump Models 7131 and 7231 The 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 Pump is available as either a single or a dual channel pump that supports the Guardrails Suite MX The Alaris SE Dual Channel Pump is a two channel pump intended to deliver multiple infusions to a single patient Guardrails Suite MX for the Pump brings a new level of medication error prevention to the point of patient care Guardrails Suite MX features programming guidelines for medication dosing delivery rate duration bolus dose and bolus dose administration rate concentration and optional initial programming values in up to 15 patient specific care areas referred to as profiles Each profile contains a specific Drug Library and an IV Fluid library as well as pump configurations appropriate for the care area
3. Starting the Infusion 1 To turn channel on press channel s POWER key The pump will run a short self test Check the display test pattern and ensure that no rows or pixels are missing 2 Confirm Profile Press change to change Profile Profile selection menu displays select profile and ok Go to step 3 Accept will retain profile and display NEW PATIENT screen 3 New Patient Answering Yes will clear all previous patient data No will retain previous patient data MENU Screen displays LJ MENU screen will show either Resume Previous Drug Resume Previous Fluid or Return to Patient is not selected Option shown will be dependent on previous infusion 4 MENU screen Select one of the following New Guardrails Drug allows a drug to be selected from the Drug Library in the data set New Guardrails Fluid allows a fluid to be selected from the Fluid Library in the data set e Basic Infusion allows infusions to be given when a drug is not listed or when a data set is not loaded e Previous infusion resume option if available 1 Before each use verify all infusion settings are appropriate for the patient New Guardrails Drug T 2 3 4 5 6 Select a drug name by pressing the adjacent soft key Select therapy or clinical indication if applicable Select Dose units and Concentration if applicable To confirm selection and continue programming press ok soft key To confirm clinical advisory
4. Optional drug specific or fluid specific clinical advisories provide visual messages Limits for each Guardrails drug or fluid entry may include Hard Limits that cannot be overridden during infusion programming and or Soft Limits that can be overridden based on clinical requirements A data set is developed and approved by the facility s own multi disciplinary team using the Editor Software the PC based authoring tool A data set is then transferred to the Pump by qualified personnel Approved data sets are maintained by the Editor Software for future updates and reference Information about a Guardrails alert that occurs during use is stored within the Pump and can be accessed using the CO Reporter The Pump may be operated with or without the Guardrails Suite MX protection When an approved data set is transferred to the Pump by qualified personnel and the Profiles feature is enabled ON in pump configuration then Guardrails Suite MX protection is available When the Profiles feature is not enabled OFF or when no data set has been transferred to the Pump Guardrails Suite MX protection is not available see Primary Infusion NO Guardrails Suite MX Protection and Secondary Infusion NO Guardrails Suite MX Protection Programming and navigation may differ when Guardrails Suite MX software is not in use About this Manual The user must be thoroughly familiar with the pump described in this manual prior to use All il
5. To enter desired VTBI use numeric keypad then press ENTER key If there is a VI value that needs to be cleared press CLEAR key or press 0 zero key then press ENTER key Verify that all parameters are correct then press run soft key or RUN HOLD key to start infusion To briefly view current profile from RUN HOLD page or during a running infusion press LM soft key En sop NS I 1000DF00479 Issue 2 13 50 Getting Started continued Resuming Previous Infusion If a channel has been powered off during an infusion previous programming may be resumed if One channel of a dual channel pump remained on Current profile is accepted and New Patient no is selected during start up 1 Select desired channel as necessary 2 Press soft key next to the resume option required Previous set up screen displays 3 Verify that all parameters are correct or change as required then press run soft key or RUN HOLD key to start infusion Pausing and Restarting Infusion 1 Aninfusion may be paused temporarily by pressing channel RUN HOLD key 2 Torestart infusion while on hold press channel RUN HOLD key Rate LED flashes while infusion is on hold After 2 minutes Hold Time Exceeded visual and audio prompts begin An additional 2 minute period may be initiated by pressing either hold soft key or channel RUN HOLD key Making Changes to Rate Dose or VTBI Continuous infusion parameters Rate Dose or VTBI may be changed without pausing t
6. x eo a 0 5 10 15 20 25 30 Observation Interval min Pressure Mode Trumpet Curve at 25 mL h 48 hr 15 o a eo a Ax o a a 0 5 10 15 20 25 30 Observation Interval min Mini Legend lll Maximum rate error Overall rate error mum rate error 1000DF00479 Issue 2 Pressure Mode Start up at 999 9 mL h initial 2000 1800 1600 1400 1200 1000 800 600 400 200 mL h 200 100 120 Time min Pressure Mode Trumpet Curve at 999 9 mL h initial Sie A e a o a Flow Rate Error a 10 15 0 5 10 15 20 25 30 Observation Interval min Pressure Mode Trumpet Curve at 999 9 mL h 24 hr 15 eo a Flow Rate Error dn o eo a 0 5 10 15 20 25 30 Observation Interval min 43 50 Resistance Mode Trumpet and Start Up Curves continued Resistance Mode Start up at 0 1 mL h initial 60 80 100 120 Time min Resistance Mode Trumpet Curve at 0 1 mL h initial 100 SE o e Oo O 20 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 0 1 mL h 48 hr 100 Boc e GG 20 Flow Rate Error 96 eo 40 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Start up at 25 mL h initial mL h 40 Legend ll Maximum rate error Overall rate error Minimum rate error 60 80 100 120 Time min 1000DF0047
7. Options continued The Multi Step feature allows a sequential drug delivery program up to 9 steps to be set delivering volumes of fluid at different rates during each step This allows the pump 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 Select desired channel as necessary Channel must be on hold in primary mode Press OPTIONS key Press Multi Step soft key Press Enter New Program soft key Select either Rate and Volume pump calculates step infusion time or Volume and Time pump calculates rate To enter values for rate volume or time as applicable use numeric keypad Press ENTER key To approve all displayed parameters and advance to next step press ok soft key Repeat steps 6 amp 7 for each additional step required 9 When all steps have been entered and accepted press done soft key 10 Toapprove and advance through review page s press ok soft key 11 To clear VI if required press CLEAR or 0 zero key Press ENTER key 12 Toapprove STEP TOTALS page press ok soft key 13 To start Multi Step infusion program press run soft key or RUN HOLD key o0 NO UT WN eS Making Changes During Multi Step The channel must b
8. KVO rate is not adjustable by the clinician Bolus Allows clinician to deliver a bolus when enabled Dose Rate Allows clinician to enter either flow rate or drug dose rate for a continuous infusion System then calculates Calculator alternate parameter based on drug concentration and weight if used For an intermittent infusion system calculates total dose based on drug amount and patient weight kg or BSA m2 if used Next clinician enters either volume and time to calculate rate or rate and volume to calculate time Dose rate calculator must be enabled in order to access Bolus Dose feature and Drug Library Loading Dose Allows clinician to set up an initial infusion rate for a specific volume to be followed automatically by a maintenance rate primary settings from same container This is useful for delivering fluid challenges Limits do not apply when using Loading Dose feature To deliver a loading dose of a medication selected from Drug Library Bolus Dose feature may be used Allows 1 24 doses to be programmed at equally spaced intervals on same pump over a 24 hour period This mode allows delivery of multiple equal doses from same IV container at regularly scheduled intervals Limits do not apply when using Multi Dose feature Within this mode a delayed start option allows pump to be programmed to delay infusion start for up to 8 hours Multi Dose Alert When enabled this feature alerts clinician of completion of each dose
9. bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Note 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1000DF00479 Issue 2 50 50 Alaris Guardrails AccuSlide and SmartSite are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries All rights reserved All other trademarks are property of their respective owners 2011 CareFusion Corporation or one of its subsidiaries All rights reserved This document contains proprietary information of CareFusion Corporation or one of its subsidiaries and its receipt or possession does not convey any rights to reproduce its contents or to manufacture or sell any product described Reproduction disclosure or use other than for the intended purpose without specific written authorization of CareFusion Corporation or one of its subsidiaries is strictly forbidden m CareFusion Switzerland 317 Sarl CH 1180 Rolle CareFusion U K 305 Ltd RG22 4BS UK 1000DF00479 Issue 2 carefusion com
10. been removed during an Reinstall set Press run soft key to restart infusion infusion setup time exceeded Pump has been turned on but Press hold soft key to return to hold mode no keys have been pressed for 10 Pump turns off if left in alarm more than 5 minutes minutes If an audio alarm remains on turn pump on and then off Battery Low Battery has 30 minutes or less of Plug power cord into an AC outlet as soon as possible charge remaining Check Entry Key press unclear Press CLEAR key to continue Checking Line Flow has been obstructed Auto Restart Plus feature must be on for downstream occlusion alerts Auto Restart Plus feature is on not required for upstream occlusion alerts Check infusion set for probable cause such as kinked tubing clogged filter etc Complete Entry ENTER was not pressed to accept a Press ENTER to confirm entry or press CLEAR twice to return to new value previous settings NOTE Channel operates as previously programmed until ENTER is pressed Resistance Alert Infusion set resistance has reached Check downstream line and site Raise resistance alert level if preset alert level appropriate Resistance Alert feature is on Additional Alerts Additional alerts provide notification of program completion and or transition to another mode Bolus Dose Complete Dose Complete Multi Dose Mode Loading Dose Complete Multi Step Complete Secondary Complete Infusion in KVO or VTBI 0 1000DF00479
11. delivered during a Multi Dose program Allows a sequential drug delivery program up to 9 steps to be set delivering volumes of fluid at different rates at each step This allows pump parameters to be set up once and deliver a step profile eliminating need to change rate and VTBI after each step of infusion Infusion may be programmed in rate volume or volume time Limits do not apply when using Multi Step feature Panel Lock When enabled this feature allows the Panel Lock keypad to be used to lock the main keypad Maximum infusion rate may be set to a value from 0 1 to 999 9 ml h in 0 1 ml h increments BSA Maximum Sets maximum patient body surface area for each profile May be set to a value from 0 05 to 3 m meters squared in 0 01 ml increments Dose Checking Dose Checking limit checking has 2 selectable options Mode Always checking option causes a Guardrails alert to occur each time a dose limit is exceeded If limit is overridden drug label displays an indicator TTT or arrows that infusion is beyond current Soft Limit Smart option causes an initial Guardrails alert to occur when a dose limit is exceeded Subsequent programming beyond dose limit does not cause an alert to display If limit is overridden drug label displays an indicator 117 or JJ arrows that infusion is beyond current Soft Limit Weight Sets maximum patient weight kg for each profile May be set to a value from 0 to 4534 kg in 1 kg increments Maxim
12. if applicable press ok soft key An optional hospital defined and editable starting value for continuous infusion dose may already be entered To enter or adjust a value use numeric keypad then press ENTER key Press ok soft key to confirm To enter desired VTBI use numeric keypad then press ENTER key If there is a VI value that needs to be cleared press CLEAR key or press 0 zero key then press ENTER key To continue programming press ok soft key Verify that all parameters are correct then press run soft key or RUN HOLD key to start infusion To briefly view setup parameters therapy concentration patient weight current profile from RUN HOLD page or during a running infusion press DN soft key 2 2 00 M New Guardrails Fluid Select a fluid name by pressing the adjacent soft key To confirm selection and continue programming press ok soft key To confirm clinical advisory if applicable press ok soft key Enter rate value use numeric keypad then press ENTER key To enter desired VTBI use numeric keypad then press ENTER key If there is a VI value that needs to be cleared press CLEAR key or press 0 zero key then press ENTER key Verify that all parameters are correct then press run soft key or RUN HOLD key to start infusion To briefly view current profile from RUN HOLD page or during a running infusion press LM soft key Co Qv Urs EE Basic Infusion Enter rate value use numeric keypad then press ENTER key
13. if no data set is loaded the configurations options are set in the configuration mode by qualified service personnel If the configuration settings need to be changed from the factory default settings reference the Technical Service Manual or contact CareFusion Technical Support for technical troubleshooting and preventive maintenance information mue Beim T Air in Line Sets upper limit for a single bolus of air to pass without alarm In other words it is amount of air allowed to pass Threshold through air in line detector before an air in line alarm sounds One of 4 different air in line detection settings can microliters be selected 50 100 200 500 ul AIL Accumulator Detects presence of multiple air bubbles that are too small to be detected by single bolus AIL detection limit Accumulator feature when enabled looks for 10 1596 of downstream fluid path to be air before giving an ACCUMULATED AIR IN LINE alarm Volume of air that trips accumulated air detection alarm varies based on current setting for single air bolus AIL Reset Allows clinician to respond to an air in line alarm assess its clinical significance and choose whether or not to continue infusion without removing air Reset feature allows only current bubble to proceed without tripping alarm Transition Tone Provides an audible tone when secondary VTBI reaches zero to indicate infusion has transitioned to primary rate Secondary to Primary Audio Volume Provides clin
14. key for desired channel Press menu soft key Press Quit Bolus soft key To start continuous infusion if one was programmed verify parameters are correct and then press run soft key or channel RUN HOLD key Bow 1000DF00479 Issue 2 15 50 Intermittent Infusion When using a drug listed in the Drug Library the drug parameters are automatically calculated based on drug amount weight entry or BSA entry if required VTBI entry time or rate entry 1 Press New Guardrails Drug soft key 2 Touse pre selection menu press soft key corresponding to first letter of desired drug 3 Press soft key next to desired drug name to select it If applicable an optional hospital defined therapy or clinical indication for delivery of this infusion may appear 4 If applicable multiple concentration listings for delivery of this infusion may appear press soft key next to desired selection 5 Toconfirm selection and continue programming press ok soft key If facility has defined a Clinical Advisory for selected drug a message appears To indicate that information has been noted and continue programming press ok soft key Enter parameters as needed Verify that all parameters are correct and press ok soft key to confirm To accept VTBI value press ENTER key or to enter another value use numeric keypad then press ENTER key If there is a VI value that needs to be cleared press CLEAR key or press 0 zero key then press ENTER key An o
15. measurements initiate the Checking Line condition the channel continues infusing in order to determine if the measured flow resistance has changed If the measured flow resistance falls to any value below 100 within 40 seconds the channel automatically resumes normal operating conditions excluding High Resistance Monitoring mode 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 data set 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 An OCCLUSION DOWNSTREAM condition is detected when 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 An OCCLUSION DOWNSTREAM condition is also detected when the configured pressure limit is exceeded This limit may be set by qualified service personnel from 1 mmHg to 600 mmHg Pressure Limit Max
16. opening closing the roller clamp H The pump is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes H This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide H Do not use the pump in a hyperbaric chamber Do not use the pump near Magnetic Resonance Imaging MRI including Stereotaxis technology 1000DF00479 Issue 2 7 50 Operating Precautions continued Operating Pressure The pumping pressure alarm system is not designed to provide protection against or detection of extravasation or tissuing complications which can occur The 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 Alarm Conditions H Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms Users must perform regular checks to e
17. selected Load Flow Regulator segment in selected channel during a manual pressure baseline setting channel Repeat manual pressure baseline operation setting Pressure Baseline feature is on SetOut sd 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 EU to go to exit SetPriVTBL Pri VTBI A primary VTBI was not AprimaryVTBI was not programmed Enter a Enter a primary VTB sd VTBI Set Pri VTBI gt Loading Dose Loading Dose VTBI entered is greater than primary Raise primary VTBI or lower Loading Dose VTBI VTBI VTBI as appropriate Stop Secondary and Infuse Run soft key was pressed in Primary Mode when a If return to primary parameters is appropriate Primary secondary infusion was on hold press yes soft key If continued secondary infusion is appropriate press no soft key Stop Timer to Change An invalid key was pressed while timer was running Wait several seconds for popup to finish Press in Multi Dose program stop timer soft key to make changes The Specified VTBI Will Only Secondary VTBI value is significantly less than bag Verify parameters are correct Press yes soft Deliver a Partial Dose volume programmed on set up page key to proceed or no soft key to return to programming Time Out of Range Programmed step time exceeds 24 hours a
18. soft key To use pre selection menu press soft key corresponding to first letter of desired drug Press soft key next to desired drug name to select it To approve all displayed information and advance to setup page press ok soft key or to change concentration or weight units press soft key next to parameter to be changed To scroll through available selections press VAN soft key When desired unit displays press ENTER key then press ok soft key to continue programming 8 Press ok soft key to confirm selection and dosing units 9 Toenter desired values use numeric keypad then press ENTER key 10 When all fields have been completed verify that all parameters are correct and press ok soft key to confirm 11 Toenter a VTBI value use numeric keypad then press ENTER key 12 If there is a VI value that needs to be cleared press CLEAR key or press 0 zero key then press ENTER key 13 Tocontinue programming press ok soft key 14 Verify that all parameters are correct and press run soft key or RUN HOLD key to start infusion 15 To briefly view current dose rate setup parameters concentration patient weight from RUN HOLD page or during a running infusion press LM soft key Qv Un Ze rb SS N If desired drug name is not listed use Drug NO DOSE LIMIT Profile features must be enabled Press New Guardrails Drug soft key Go to end of drug list and select Drug NO DOSE LIMIT Enter parameters as needed Verify that all
19. 8 Section 51 101 b 1000DF00479 Issue 2 36 50 Specifications continued Environmental Operating Storage Conditions Atmospheric Pressure 700 to 1060 hPa 500 to 1060 hPa Relative Humidity 20 to 90 Non condensing 5 to 95 Non condensing Temperature Range 5 to 40 C 41 to 104 F 40 to 60 C 40 to 140 F 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 Electrical leakage current enclosure 100 microamperes Leakage Electrical leakage current patient 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 For rates greater than 1 ml h up to 999 9 ml h 5 95 of time with 9596 confidence under conditions listed below For rates equal to or less than 1 ml h 56 596 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 6132 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 Variations of head height back pressure time monitoring mode option pump tilt or any combination of these may affect rate accuracy Factors that can influ
20. 9 Issue 2 mL h Flow Rate Error 96 E dn o a a a Flow Rate Error dn o a a a a 44 50 Resistance Mode Start up at 1 mL h initial 20 Resistance Mode Trumpet Curve at 1 mL h initial 5 Resistance Mode Trumpet Curve at 1 mL h 48 hr 5 40 10 60 Time min 15 8 20 Observation Interval min 10 Observation Interval min 15 20 0 100 25 25 Resistance Mode Start up at 999 9 mL h initial 20 40 60 Time min 80 100 120 30 30 120 Trumpet and Start Up Curves continued Resistance Mode continued Resistance Mode Trumpet Curve at 25 mL h initial Resistance Mode Trumpet Curve at 999 9 mL h initial 15 10 p 5 0 a g o g ZS 5 D D 10 15 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min i Resistance Mode Trumpet Curve at 25 mL h 48 hr Resistance Mode Trumpet Curve at 999 9 mL h 24 hr 5 10 B 5 2 0 2 5 uw D 10 15 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min High Resistance Mode bod High Resistance Mode Start up at 999 9 mL h initial High Resistance Mode Trumpet Curve at 999 9 mL h initial 1800 1600 4400 1200 1000 E 800 600 400 200 Flow Rate Error 96 200 0 20 40 60 80 100 120 0 5 10 15 20 25 30 Time min Observation Interval min High Resistance Mo
21. Alaris SE Pump Directions For Use Models 7130 7131 and 7230 7231 Supports Guardrails Suite MX en A ee e mt 2 Aboutthis Manual eer 2 FEATULES E E a a E 3 LEE eO ied nOD Cier ce 4 UIS DD Dnge 5 sg Display Features es m 6 Operating Precautions idare vovve H Getting Started WE 10 E EA m 10 Pole Clamp Installation isicscscccccsssncesdconcescvosscnncvccsuevenveteesccovssscsanvetsensesseotdesndesedvccedestesvecedeveevesdsaes cusedcvcucedednessucesevene 10 PHIMING aN INFUSION Set ssscsccsscsccssscsssessesesscssssiucsussssessocsssunseusssonssedsessnssussdsussedsasusssdstsessessssussadesdoccsssedensastedevsseessces 11 Loading an Infusion Set M 12 Starting the INTUSION E 13 LEM UE 15 uliicnisindhitilEe m 16 Secondary INFUSION pec 17 LEE Uinc 18 PrOMOtinig Basic DIL ID e M 18 Dose Rate Calculator cs sisssesiscessescsscsscesssvessessssesseasscassocsssunscesssonsseasesunssuasceuseodsasdessedstsesesasesuessdecsetssessstonsagveievescasstes 18 Loading DOSE mE 19 LEN UI Ee E 20 DEB CliCmee
22. Ensure sets are not kinked as this may occlude the tubing Using Collapsible bags Glass Bottles and Semi Rigid containers It is recommended that the air vent be opened on the infusion set if using glass bottles or semi rigid containers to reduce the partial vacuum formed as the fluid is infused from the container This action will ensure the pump can maintain volumetric accuracy whilst the container empties The action of opening the air vent for semi rigid containers should take place after the spiking of the container and priming of the drip chamber Steps for Glass Bottles and Semi rigid containers Steps for the Collapsible bags Follow steps 1 to 3 as shown for the semi rigid containers however do not Spike the 4 open vent as in step 4 but prime the Open the air vent 3 Fill drip EE chamberto Si to allow pressure set as per step 5 Ensure the bag outlet AN equalisation ready is fully pierced before filling the drip for infusion chamber 1 Close the roller clamp Operating Environment H When using any infusion pump in conjunction with other pumps or devices requiring vascular access extra care is advised Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the fluid channels of such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications Prime the set by
23. F00479 Issue 2 24 50 Options continued Monitoring Options continued Pressure Baseline The Pressure Baseline feature when enabled through the hospital data set profile configuration settings provides a real time bar graph and numeric display of line pressure The pressure limit may be reduced if the pressure in the set 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 may need to be set a second time after the pressure readings have stabilized For dual channel pumps select the desired channel as necessary The pressure bar graph is not shown when the split screen display is active For optimal results set the baseline 15 minutes after starting an infusion The pressure baseline can be optimised 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 To place channel on hold press channel s RUN HOLD key All infusions connected to channel being baselined must be on hold Press OPTIONS key Press Set Pressure Baseline soft key Verify no pressure due to occlusi
24. Issue 2 28 50 Alarms Alerts and Prompts continued Air detector has detected air prior to starting infusion or is in poor contact with set Press continue soft key to allow infusion to continue An alarm occurs if air detector detects an air bubble larger than configured threshold Verify set is loaded correctly Prime and reload set or remove air Reshape tubing to ensure optimum contact with sensor Ensure air in line sensors are thoroughly cleaned Dose Out of Range Calculated dose is outside allowable range Verify and re enter settings Entry Invalid An invalid value was entered during programming Press CLEAR or 0 key to clear entry Enter appropriate value Instrument Self Check Is Due Please Eject the Set Pump channel has not performed self check within programmed interval Invalid Entry Rate Out of Range Latch Open Latch is open prior to starting an infusion Maintenance Reminder Periodic maintenance interval has elapsed Maintenance Reminder feature is on Max Rate XXX X ml h An attempt was made to enter a rate greater than maximum configured rate or pump has calculated a rate greater than maximum configured rate Default maximum rate is 999 9 ml h in primary mode 600 ml h in secondary mode XXX X represents maximum flow rate configured for pump or profile New Baseline Set A new Manual Pressure Baseline was successfully set Manual Pressure Baseline feature is on Occlusion Downstrea
25. 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 FLOW CHARACTERISTICS UNDER VARYING DELIVERY CONDITIONS Effects of Pressure Variations Under conditions of 100 mmHg pressure the Pump typically exhibits a long term accuracy offset of approximately 1 4 from mean values Under conditions of 300 mmHg pressure the Pump typically exhibits a long term accuracy offset of approximately 1 5 from mean values Under conditions of 100 mmHg pressure the Pump typically exhibits a long term accuracy offset of approximately 0 896 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 Pump typically exhibits a long term accuracy offset of approximately 5 896 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 Tests conducted in accordance with IEC EN 60601 2 24 Particular requirements for safety of infusi
26. UT gt 95 96 dip in UT for 0 5 cycle 40 96 UT 60 96 dip in UT for 5 cycles 7096 UT 30 96 dip in UT for 25 cycles lt 5 96 UT gt 95 96 dip in UT for 5 sec Note 1 Ur is the AC mains voltage prior to application of the test level Note 2 Compliance levels raised by IEC EN 60601 2 24 Note 3 Performed at the Minimum and Maximum Rated Input Voltage Note 4 CareFusion recommends using signal cables of less than 3 meters in length and this requirement is applicable only if signal cables are 3 meters or more in length IEC EN 60601 1 2 2002 Clause 36 202 4 1000DF00479 Issue 2 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 If connector testing exemption is used the following symbol for ESD sensitivity appears adjacent to each connector Caution Do Not Touch AA Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the pump requires continued operation during power mains interruptions it is recommended that the pump be powered from an uninterruptible power
27. all establishments including domestic Harmonic Emissions establishments and those directly connected to a public low voltage power supply network that supplies buildings used for domestic purposes IEC EN 61000 3 3 Voltage Fluctuations Complies Flicker Emissions 1000DF00479 Issue 2 47 50 Compliance continued Guidance and Manufacturer s Declaration Electromagnetic Immunity The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should assure that it is used in such an environment nm ES Compliance Level Electromagnetic Environment Guidance IEC EN 61000 4 2 Electro Static Discharge ESD IEC EN 61000 4 4 Electrical Fast Transient Burst EFT Note 3 IEC EN 61000 4 5 Power Line Surge Note 3 IEC EN 61000 4 8 Power Frequency Magnetic Field 50 60 Hz IEC EN 61000 4 11 Voltage Dips Short Interruptions and Voltage Variations Note 3 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV Line s to Line s 2 kV Line s to Earth lt 5 UT Note 1 gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 96 UT gt 95 96 dip in UT for 5 sec 8 kV contact Note 2 15 kV air Note 2 2 kV for power supply lines N A Note 4 1 kV Line s to Line s 2 kV Line s to Earth 400 A m 50 Hz Note 2 5 96
28. ance 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 Resistance Alert marker can be set by from 0 to 100 of scale in 5 increments Resistance Display must also be enabled To optimise alert feature it is advisable to set alert level 20 3096 higher than initial displayed resistance which should be read approximately 2 minutes after starting an infusion Resistance When enabled provides a bar graph on Main Display to indicate current 96 resistance on a scale of 0 100 When Display disabled resistance alert feature is unavailable 1000DF00479 Issue 2 33 50 Configurable Settings continued mue Beim Resistance Provides an Occlusion Downstream alarm when measured pressure reaches Resistance Pressure limit while Pressure Setting operating in Resistance Mode This threshold may be set from 1 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 2 ways measured resistance reaches 10096 of scale or configured Resistance Pressure Setting is exceeded KVO Rate KVO keep vein open mode automatically occurs when primary VTBI has counted down to 0 0 ml Channel switches to preset KVO rate or remains at current rate whichever is less KVO rate may be set to a value between 0 1 and 20 ml h in 0 1 ml h increments
29. aned battery depleted Plug In Battery is too low to operate Plug power cord into an AC outlet immediately Press run soft pump key or RUN HOLD to resume infusion channel malfunction Channel malfunction Turn channel off and then on If problem persists do not use Dual channel pump only channel Contact qualified service personnel computer link failure RS 232 connection to computer Check RS 232 connections was disrupted Clearing this alarm automatically puts pump in monitor mode Computer Link feature is in Reestablish infusion monitor mode flow sensor unplugged Flow sensor is unplugged from Plug flow sensor into flow sensor receptacle back of pump hold time exceeded Channel has been on hold for 2 Press hold soft key to return to hold mode minutes and no keys have been pressed on either channel if dual channel 1000DF00479 Issue 2 27 50 Alarms Alerts and Prompts continued Alarms continued instrument malfunction Pump malfunction For a dual Turn pump off and then on If problem persists do not use channel pump neither channel pump Contact qualified service personnel is functional key stuck A key is stuck or was held down Release key Turn pump off both channels if dual channel too long pump and then on If problem persists do not use pump Contact qualified service personnel latch open Latch was opened during an Check for proper set installation Close latch fully to the left infusion Press run s
30. annel is selected ALERT may indicate a 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 When using the dual channel pump some messages also display Channel A or Channel B to indicate which channel is affected Always verify the channel is selected before making any changes accumulated air in line Air detector has detected Air detector has detected multiple small bubbles multiple small bubbles Press hold soft key Open latch to remove set Clear air per hospital protocol Reinstall set Press Run Hold to resume infusion 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 detector has detected an air Air detector has detected an air bubble larger than configured bubble larger than configured threshold tolerance threshold tolerance Press hold soft key Open latch to remove set Clear air per hospital protocol Reinstall set Press RUN HOLD to resume infusion 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 upstream fluid path is unobstructed Ensure air in line sensors are thoroughly cle
31. ardrails alerts that are overridden Counter increments when yes is selected in response to soft override alert prompt Total number of Soft Limit Guardrails alerts that occur Counter increments when either yes or no is selected in response to soft override alert prompt Total number of infusion starts A start occurs when run key is selected from an inactive or paused condition For dual channel pumps the counters represent the total counts for both channels Theseare the counter labels as they appear on the Main Display 1000DF00479 Issue 2 31 50 Flow Sensor Operation optional The optional flow sensor notifies users of empty containers and or upstream Flow Sensor Connectors 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 delivered when changing from secondary to primary This is to account for overfill of secondary containers If a flow sensor is not connected to the pump ensure 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 pump 2 Attach flow sensor to upper portion of drip chamber Attach flow sensor to pump handle when not in use 4 Routinely clean flow sensor with warm water while actuating slider then dry thoroughly e Infusing fluids which form smaller drops through a 60 drop
32. ations regarding electromagnetic interference EMI For further information please refer to the product technical service manual TSM Alternatively contact your local CareFusion representative for further guidance Accessories Do not use any non recommended accessory with the pump The pump is tested and compliant with the relevant EMC claims only with the recommended accessories Use of any accessory transducer or cable other than those specified by CareFusion may result in increased emissions or decreased pump immunity Earth Conductor e The pump is a Class device therefore must be earthed when connected to an AC power supply This pump also has an internal power source e When connected to an external power source a three wire Live Neutral Earth supply must be used If the integrity of the external protective conductor on the AC power cable has been compromised the pump should be disconnected from the AC power source and operated utilising the internal battery 1000DF00479 Issue 2 8 50 Operating Precautions continued An explosion hazard exists if the pump is used in the presence of flammable anaesthetics Exercise care to locate the pump away from any such hazardous sources Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel If this pump is dropped subjected to excessive moisture fluid spillage humidity or high t
33. cause improper operation resulting in an inaccurate fluid delivery or other potential hazard Position the fluid container to avoid spillage onto the pump Slide Flow Regulator thumb clamp down until an audible click verifies it is in fully closed position Using both hands press top and bottom of Flow Regulator into pump until it snaps into place Verify 3 gray fingers clamp arms on each side of pumping mechanism have engaged Flow Regulator Let go of set A properly loaded set should stay in pump Press firmly just below blue thumb clamp on Flow Regulator with one hand while using other hand to close latch fully to left If resistance is met while closing latch remove set verify Flow Flow Regulator Regulator is fully closed and then reinstall set Verify thumb clamp has moved to open up position prior to starting infusion Attach set to patient s vascular access device Verify flow from IV container after starting infusion Place channel on hold Open latch Flow Regulator automatically closes to prevent accidental unintended flow Press latch fully to right Set is ejected from pump Verify the Flow Regulator is closed when the infusion set is removed from the pump to prevent unintended flow Do not attempt to force the infusion set from the pump Contact a qualified service engineer for investigation 1000DF00479 Issue 2 12 50 Getting Started continued
34. cobendas Madrid Espana Tel 34 902 555 660 Fax 34 902 555 661 FR CareFusion Parc d affaire le Val Saint Quentin 2 rue Ren Caudron 78960 Voisins le Bretonneux France T l 33 1 30 05 34 00 Fax 33 1 30 05 34 43 GB CareFusion The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 HU CareFusion D brentei t r 1 H 1013 Budapest Magyarorsz g Tel 36 1 488 0232 Tel 36 1 488 0233 Fax 36 1 201 5987 IT CareFusion Via Ticino 4 50019 Sesto Fiorentino Firenze Italia T l 39 055 30 33 93 00 Fax 39 055 34 00 24 NL CareFusion De Molen 8 10 3994 DB Houten Nederland Tel 31 0 30 2289 711 Fax 31 0 30 2289 713 NO CareFusion Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 1000DF00479 Issue 2 46 50 NZ CareFusion 14B George Bourke Drive Mt Wellington 1060 PO Box 14 518 Panmure 1741 Auckland New Zealand Tel 09 270 2420 Freephone 0508 422734 Fax 09 270 6285 PL CareFusion ul Rzymowskiego 53 02 697 Warszawa Polska Tel 48 225480069 Fax 48 225480001 SE CareFusion Hammarbacken 4B 191 46 Sollentuna Sverige Tel 46 8 544 43 200 Fax 46 8 544 43 225 US CareFusion 10020 Pacific Mesa Blvd San Diego CA 92121 USA Tel 1 800 854 7128 Fax 1 858 458 6179 ZA CareFusio
35. conds and allow to dry approximately 30 seconds NOTE Dry time is dependent on temperature humidity ventilation of the area 2 Prime valve port If applicable attach syringe to Needle Free Valve port and aspirate minuscule air bubbles 3 Replace every 72 hours for stand alone valves However if the valve is part of the set then the set change interval is as per the complete set or 100 activations which ever occurs first For infusions of blood blood products or lipid emulsions replace infusion set every 24 hours NOTE During use of Needle Free Valve port fluid may be observed between the housing and blue piston This fluid does not enter the fluid path and requires no action For product questions or needle free valve educational materials contact your Cardinal Health Alaris Products representative The Center for Disease Control Intravenous Nurses Society USA and other organizations publish guidelines useful in developing facility guidelines Consult facility protocols AU 1000DF00479 Issue 2 26 50 Alarms Alerts and Prompts There are 3 types of displayed messages listed on the following pages with a probable cause and suggested remedy next to each one Use this section in conjunction with the appropriate clinical practice of hospital procedure ALARM pump or channel problem e infusion stops e alarm bell icon illuminates alarm tone sounds e rate LED display flashes e message appears in Main Display when ch
36. correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient Prepare the primary solution container in accordance with the manufacturer s directions for use Use only sets dedicated for use with the Alaris SE Pump 1 Slide Flow Regulator thumb clamp down until an audible click verifies it is in fully closed position 2 Spike solution container 3 Fill drip chamber to 2 3 full Open the vent cap on the spike if the container requires venting Invert Flow Regulator Slide up to open Slide Flow Regulator thumb clamp to open position to slowly prime set for priming Close Flow Regulator clamp when priming is complete as in Step 1 Verify no fluid is flowing 7 A gravity flow rate may be adjusted with Flow Regulator thumb clamp if desired Slide down to close for loading 1000DF00479 Issue 2 11 50 Getting Started continued Removing the Infusion Set 1 2 3 4 Loading an Infusion Set After set installation verify no fluid is flowing through the infusion set s drip chamber to avoid free flow Before operating pump verify that infusion set is free from kinks and installed correctly in pump Ensure the appropriate infusion set for the fluid drug to be infused has been selected Follow the instructions supplied with the individual infusion set Use only sets dedicated for use with the pump The use of any other set may
37. d from those used for other types of administration The Pump can be used for epidural administration of anaesthetic and analgesic drugs This application is only appropriate when using anaesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use Use only sets dedicated for use with the Pump without a Y connector or injection port for epidural infusions Epidural administration of anaesthetic drugs Use indwelling catheters specifically indicated for short term 96 hours or less anaesthetic epidural drug delivery Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery 1000DF00479 Issue 2 9 50 Getting Started 1 Before operating the pump read this Directions For Use DFU manual carefully Initial Set Up 1 Check that the pump is complete undamaged and that the voltage rating specified on the label is compatible with your AC power supply 2 Items supplied are Alaris SE Pump Directions For Use CD AC Power Cable as requested Protective Packaging 3 SCC the pump to the AC power supply for at least 24 hours to ensure that the internal battery is charged verify that the AC Mains indicator is lit Maximum battery capacity as well as gauge accuracy is reached after several charge discharge recharge cycles in the refresh process CareFusion rec
38. de a pressure trend graph is available and when it is operating in resistance mode a resistance trend graph is available Manual Pressure Provides a real time bar graph and numeric display of line pressure Baseline When Pressure Display is enabled Pressure Alarm may be set to Adjustable Pressure mode or Fixed Pressure mode Pressure Display In Adjustable Pressure monitoring mode pressure alarm limit may be varied by from 25 mmHg to maximum configured pressure limit in 25 mmHg increments Pressure Display indicates current pressure limit and provides ability to adjust limit by pressing increase or decrease arrows In Fixed Pressure mode pressure limit of 600 mmHg displays with no means of adjusting it When Pressure Display is disabled pump automatically defaults to Fixed Pressure mode Pressure Limit This is default pressure alarm limit that is automatically set when pump is powered on and a new profile is selected Initial or New Patient Yes is selected Alarm level must be less than or equal to maximum pressure limit Pressure Limit In Adjustable Pressure monitoring mode pressure alarm limit may be varied by from 25 mmHg to this maximum Maximum configured pressure limit in 25 mmHg increments A value that exceeds this pressure limit cannot be selected Default Default resistance alert level that is automatically set when pump is powered on and a new profile is selected or Resistance Alert New Patient Yes is selected Resist
39. de Trumpet Curve at 999 9 mL h 24 hr Flow Rate Error 96 Legend ll Maximum rate error 0 5 10 15 20 25 30 Observation Interval min Overall rate error Minimum rate error 1000DF00479 Issue 2 45 50 Service Contacts For service contact your local Affiliate Office or Distributor AE CareFusion PO Box 5527 Dubai United Arab Emirates Tel 971 4 28 22 842 Fax 971 4 28 22 914 AU CareFusion 3 167 Prospect Highway PO Box 355 Seven Hills NSW 2147 Australia Tel 61 2 9838 0255 Fax 61 2 9674 4444 BE CareFusion Leuvensesteenweg 248 D 1800 Vilvoorde Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA CareFusion 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CH CareFusion Switzerland 221 Sarl Critical Care A One Business Centre Zone d activiti s Vers la Pi ce n 10 1180 Rolle Switzerland Ph 0848 244 433 Fax 0848 244 100 CN CareFusion BRR rhE ESTbSKEAER 500 amp EBRR DFA H A 24 B Hid 200122 if 86 21 58368018 H 86 21 58368017 DE CareFusion Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 604 0 Fax 49 2401 604 121 DK CareFusion Firskovvej 25 B 2800 Lyngby Danmark TIf 45 70 20 30 74 Fax 45 70 20 30 98 ES CareFusion Edificio Veganova Avenida de La Vega n 1 Bloque 1 Planta 1 28108 Al
40. ding the system or filtering the connection to the public mains network are examples of steps that can be taken to reduce or eliminate interference However this pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC EN60601 2 24 and IEC EN60601 1 2 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation Therapeutic Radiation Equipment Do not use the pump in the vicinity of any Therapeutic Radiation Equipment Levels of radiation generated by the radiation therapy equipment such as Linear Accelerator may severely affect functioning of the pump Please consult manufacturer s recommendations for safe distance and other precautionary requirements For further information please contact your local CareFusion representative Magnetic Resonance Imaging MRI The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices Therefore the pump is not considered an MRI compatible pump as such If use of the pump within an MRI environment is unavoidable then CareFusion highly recommends securing the pump at a safe distance from the magnetic field outside the identified Controlled Access Area in order to evade any magnetic interference to the pump or MRI image distortion This safe distance should be established in accordance with the manufacturers recommend
41. e function is performed 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 If current system pressure is same or higher than original baseline pressure baseline does not change If current system pressure is less than original baseline system automatically resets to new system pressure value Pressure measurement can be optimised particularly at low flow rates less than 3 ml h by pausing and restarting at least once every 2 hours This allows pressure baseline to calibrate based on current system pressure Prior to activation ensure that pressure has not built up in infusion set due to either occlusion or flow from other pumps through a common catheter This will result in a more accurate pressure measurement When loading a set connected to a small diameter catheter wait at least 5 seconds after loading set before activating RUN HOLD This allows pressure generated by loading process to dissipate and sensor to stabilise Very small PICC catheters such as 28 gauge 1 2 French may require 60 seconds or more for stabilisation When multiple pumps are infusing through a common small diameter catheter pressure measurement accuracy can be optimised by temporarily stopping all infusions then restarting all pumps beginning with pump delivering at lowest rate 1000D
42. e is required see Making Changes During Multi Step 7 Toapprove review page s and STEP TOTALS page press ok soft key 8 Tocontinue or restart program press RUN HOLD key or run soft key Quitting Multi Step The channel must be on hold or the last dose complete 1 Press menu soft key 2 Toreturn to primary set up page press Quit Program soft key 1000DF00479 Issue 2 21 50 Options continued Monitoring Options All features and options in this section are shown enabled Options are enabled through the hospital data set profile configuration settings or through the pump configuration settings if the Profiles feature is not enabled OFF 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 infusion set site monitoring modes of resistance high resistance and adjustable or fixed pressure Auto Restart Plus Feature allows pump to automatically resume operation when specific pump operating conditions are met Adjustable Resistance Alert to provide an early warning of increases in downstream flow resistance Adjustable Pressure Alarm to provide an early warning of increases in downstream pressure Trend Graph to display down
43. e on hold to view or edit the steps in the program 1 To place channel on hold press RUN HOLD key 2 Toreturn to review page s press setup soft key A tick mark I next to a step on review page s indicates it has not started e Only steps having a I can be edited A step number in progress is highlighted To advance through review page s of program press ok soft key To select a step for editing press a soft key To select value for editing press a soft key To enter new value use numeric keypad Press ENTER key To return to review page s when programming is complete press ok soft key To approve review page s and STEP TOTALS page press ok soft key To resume infusion press RUN HOLD key or run soft key 10 00 X Qv MY cud Viewing Totals Remaining Press M soft key Time and VTBI remaining in Multi Step program display for a short interval Resuming an Interrupted Multi Step The channel retains its place in the program if the pump is turned off The program can be restarted from step 1 or resume where it left off 1 Select desired channel as necessary 2 Select New Patient and Profile Options as necessary Return To Multi Step page appears 3 Press yes soft key 4 Press Review Resume soft key 5 Toresume program from point of interruption press Continue Program soft key or to restart program at beginning of step 1 press Restart Program soft key 6 Verify all settings are correct If a chang
44. econdary infusion set 6 Press the SEC key Secondary Menu displays 1 7 8 Choose Guardrails SEC Drug or Basic SEC at least 24cm Sn Enter parameters as required following on screen prompts See primary E H infusion set ups for more detail kaad 9 Verify all parameters are correct and press ok soft key 10 Press yes soft key to confirm Secondary Clamp is open 11 Verify that all parameters are correct and press run soft key or RUN HOLD J key to start infusion Primary 12 To briefly view setup parameters therapy total dose concentration patient container d weight or BSA current profile from RUN HOLD page or during a running infusion press M soft key Back Check u valve ah Y Site p Secondary Infusion Preparation WARNING Secondary applications require the use of a check valve set on the primary infusion set Secondary infusion applications using a check valve set must have a VTBI setting equal to the volume in the secondary container this will require consideration of such variables as factory overfill medication additions etc Underestimating the volume will cause remaining secondary solution to be infused at the primary rate overestimating will result in primary solution being infused at the secondary rate essential for proper operation 1 When using a flow sensor it must be on the primary infusion set Correct placement of a flow sensor is 1000DF00479 Iss
45. ectronic equipment please contact your CareFusion affiliate office or distributor for further information Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling Information on Disposal in Countries outside the European Union This symbol is only valid in the European Union The product should be disposed of taking environmental factors into consideration To ensure no risk or hazard remove the internal rechargeable battery and the Nickel Metal Hydride battery from the control board and dispose of as outlined by the local country regulations All other components can be safely disposed of as per local regulations 1000DF00479 Issue 2 39 50 RS232 Computer Link The optional Computer Link feature allows a hospital facility computer to interact with the pump The computer cannot start or stop the pump set the rate or make any change in status The feature may be enabled or disabled by qualified personnel in the pump configuration settings If the feature is enabled On the user may select Monitor to allow the computer to receive information from the pump or Off When Off is selected the computer cannot communicate with the pump To assure continued electromagnetic compatibility performance the communications cable attached to the pump should be no longer than 1 meter have fully shielded c
46. ed Separation Distances for LIFE SUPPORT Equipment between portable and mobile RF communications equipment and the Pump The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the pump as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Maximum Output Power of Transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Outside ISM bands In ISM bands For transmitters rated at a maximum output power not listed above 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 W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range apply Note 2 The ISM Industrial Scientific and Medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency
47. efully read the Directions For Use supplied with the infusion set prior to use Keep Vein Open KVO Mode When the primary VTBI reaches 0 0ml the pump automatically switches to the configured KVO rate or remains at the current infusion rate whichever is less KVO rate flashes in rate LED display Programmed infusion rate continues to display in Main Display KVO flashes in infusion status bar KVO alert tone sounds may be silenced for 2 minutes using Silence key VTBI 0 INFUSION IN KVO message flashes in Main Display To exit KVO mode press RUN HOLD key to place channel on hold Press VTBI soft key VTBI is highlighted To enter desired VTBI use numeric keypad then press ENTER key Toresume infusion press run soft key or RUN HOLD key PUPS Clearing Volume Infused The volume infused counter increments as fluids are infused through a given channel All fluids infused in primary mode including boluses all fluids infused in secondary mode and all fluids infused in KVO mode are counted 1 Toreset volume infused counter to 0 0ml press VI soft key VI field is highlighted 2 Press CLEAR key or press 0 zero key then press ENTER key 1000DF00479 Issue 2 14 50 A Bolus can be programmed at the beginning of or during a continuous infusion The drug being programmed must be a drug selected from the Drug Library that has bolus enabled Bolus volume must be at least 1 ml and not more than 999 9 ml Bolus paramete
48. emperature or otherwise suspected to have been damaged remove it from service for inspection by a qualified service engineer When transporting or storing the pump use original packaging where possible and adhere to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging If this pump behaves abnormally remove from service and contact a qualified service engineer Guardrails Suite MX The Guardrails Suite MX incorporates dosing limits and pump configuration parameters based on hospital facility protocol The software adds a test of reasonableness to drug programming based on the limits defined by the hospital facility Qualified personnel must ensure the appropriateness of drug dosing limits drug compatibility and pump performance as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates and pressure alarms and nuisance alarms When delivering an infusion with the Guardrails Suite MX protection ensure the correct profile for patient care area is selected prior to starting an infusion Failure to select the appropriate profile could cause serious consequences Epidural Administration Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient It is strongly recommended that the source container infusion set and Pump used for epidural drug delivery be clearly differentiate
49. ence head height and back pressure are Infusion set configuration IV solution viscosity and IV solution temperature Back pressure may also be affected by catheter type See Trumpet and Start up Curves for data on how certain factors influence rate accuracy Volume Infused 0 0 to 9999 9 ml in 0 1 ml increments Range VTBI Range 0 1 to 9999 9 ml in 0 1 ml increments Basic Infusion Drug Library Primary Infusion IV Fluid Infu sion and Multi Step mode 0 1 to 999 9 ml in 0 1 ml increments all other modes 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 1000DF00479 Issue 2 37 50 Maintenance Routine Maintenance Procedures To ensure that this pump remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below All servicing should only be performed by a qualified service engineer with reference to the Technical Service Manual TSM Circuit diagrams and components parts lists and all other servicing information which will assist the qualified service engineer in performing repair of the parts designated as repairable are available upon request from CareFusion If the pump is dropped damaged subjected to excessive moisture or high temperature immediately take it out of service for examination by a qualified service enginee
50. equirement that no modifications will be made to the system unless the changes or modifications are expressly approved by CareFusion This Class A B digital apparatus meets all requirements of the Canadian Interference Causing Equipment Regulation Tables The Pump is intended for use in the electromagnetic environments specified in the following tables Guidance and Manufacturer s Declaration Electromagnetic Emissions The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should assure that it is used in such an environment The pump is suitable for use in all establishments 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 CISPR 11 Group 1 Caution RF Emissions Class A The 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 may 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 CISPR 11 Group 1 RF Emissions Class B IEC EN 61000 3 2 Class A The pump is suitable for use in
51. es Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note 3 Compliance levels raised by IEC EN 60601 2 24 aThe compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges b Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and 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 pump is used exceeds the applicable RF compliance level above the pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the pump c Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 1000DF00479 Issue 2 49 50 Compliance continued Recommend
52. he infusion and VI may be cleared 1 Select desired channel as necessary 2 Press soft key next to parameter to be edited Current value is highlighted 3 Make changes To enter a new value use numeric keypad or to reset Volume Infused to 0 0 ml press CLEAR or 0 zero key 4 Toaccept new value press ENTER key Making Changes to Concentration or Patient Weight Infusion must be paused before making changes If a drug with a defined standard concentration was selected Conc concentration values are not editable 1 To pause infusion press channel s RUN HOLD key 2 Press set up soft key 3 Press soft key next to parameter to be edited Current value is highlighted 4 Toentera new value use numeric keypad then press ENTER key Changing the Infusion Set To pause infusion press channel s RUN HOLD key Close in line clamp and ensure the access to the patient is isolated Disconnect the infusion set from the patient Remove infusion set from the pump and discard the set and fluid container according to hospital protocol Prepare the new infusion set load infusion set into pump and close the door see Priming the Infusion Set and Loading the Infusion Set Restart infusion see Getting Started VIE NS o H When changing the infusion set or the fluid container use aseptic technique according to hospital protocol It is recommended that infusion sets are changed in accordance with the Directions For Use Car
53. ician with ability to adjust audio volume for alarms alerts and KVO tone to either High Medium or Low if all audio volume levels are enabled Audio volume indicator in lower LCD display indicates audio volume selected Pump can be configured to enable only Medium and High or only High audio volume levels if desired Allows a 4 digit pump ID label to appear in lower LCD display identifying patient care profile Name Auto Restart Plus Part of the Dynamic Monitoring system and designed to help minimize nuisance occlusion downstream alarms It allows pump to automatically continue an infusion following detection of a downstream occlusion if downstream pressure falls to an acceptable level within a 40 second Checking Line period May be set to off 0 restarts or to allow from 1 9 Checking Line restarts If allowable number of restarts is exceeded or when resistance or pressure conditions indicate an occlusion an occlusion downstream alarm occurs Monitoring Dynamic monitoring provides clinician ability to select one of following monitoring modes Resistance mode High Options 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 if pump is operating in pressure mo
54. ify parameters are correct and press ok soft key to transition from continuous to bolus infusion 7 When bolus dose completes an audio tone sounds and Bolus Dose Complete briefly displays and infusion automatically transitions back to continuous rate dou aes o Bolus Only The Bolus Only feature is used to deliver single boluses from a fluid container without delivering a continuous infusion The feature is not available once a continuous dose or rate has been entered or if an initial value for continuous infusion dose has been entered in the data set 1 Prior to entering a dose or rate press BolusOnly soft key 2 Anoptional hospital defined and editable starting value for bolus dose may already be entered or to enter a value use numeric keypad then press ENTER key 3 Anoptional hospital defined bolus dose administration rate may have been used to calculate an editable Time in minutes 1 99 to deliver programmed bolus dose or to enter a time value use numeric keypad then press ENTER key Verify parameters are correct and press ok soft key Verify that bag contains an adequate volume to deliver programmed dose as specified and press ok soft key Verify that all parameters are correct and press run soft key or RUN HOLD key to start infusion When bolus dose completes an audio tone sounds and Bolus Dose Complete displays until user takes action Press menu key to return to Bolus Menu d n ZS Stopping a Bolus Press RUN HOLD
55. imum 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 data set 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 2 minutes after starting an infusion Setting Alert Marker e To numerically display present alert level marker press either 41 or r soft key Vertical line on resistance bar graph visually indicates alert level e Each additional press of either arrow soft key increases or decreases alert level marker and numeric value by 5 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 hours are available during normal operation when enabled through the hospital data set Downstream Occlusions are indicated by a tick mark I at the top of the trend screen For dual channel pumps select the desired channel as necessary The trend graph is not available while the split screen is displayed 1 Press OPTIONS key 2 Press Resistance Trend soft key 3 Tochange graph time frame press time soft key e A dashed horizontal line represents current resistance alert level e Gaps
56. in graph may indicate non infusing 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 A tick mark I at top of graph indicates an occlusion When viewing Resistance Trend Graphs in High Resistance mode HI RESIST displays under graph To clear graphed data press clear soft key and then ok to confirm Press return soft key to return to normal operating screen 1000DF00479 Issue 2 23 50 Options continued Monitoring Options continued Adjustable Pressure Alarm 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 A default alarm level and a maximum pressure limit are set through the hospital data set profile configuration settings or through the pump confirmation settings if the Profiles feature is not enabled OFF Pressing either arrow tor soft key changes alarm limit by 25 mmHg in corresponding direction It is advisable to select an alarm limit appropriate for flow rate At lower flow rates alarm limit should be set lower to shorten time to alarm Pressure Monitoring Using Automatic Baseline Calibration The auto pressure baseline calibration remains in effect until the pump is turned off the latch is opened the set is reloaded or the Set Pressure Baselin
57. ing dose infusion press Primary Settings soft key 9 Tochange Primary Settings during a loading dose infusion press Primary Settings soft key 10 Press soft key next to parameter to be edited 11 To enter a new value use numeric keypad or to reset volume infused to 0 0 ml press CLEAR or 0 zero key 12 To accept new value press ENTER key This mode is useful for delivering fluid challenges This feature is for delivery from primary containers only Using this feature with 2 separate containers may result in unintended flow rates 1000DF00479 Issue 2 19 50 Options continued This feature allows 1 to 24 infusions to be preprogrammed with 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 up to 8 hours and a Dose Complete Alert Option These features can be turned on or off This program requires another infusing line to keep the vein open between programmed doses since there is no KVO infusion between doses or following program completion OS NO UT B wo c o Select desired channel as necessary Channel must be on hold in primary mode Press OPTIONS key Press Multi Dose soft key Press Enter New Program soft key To enter infusion rate use numeric keypad Press ENTER key To enter VTBI Dose use numeric keypad Press ENTER key To enter number of doses use numeric keypad Press ENTER key To enter dose frequency time in
58. l inspection They do not represent a full calibration check See the Technical Service Manual for a complete list of the test procedures and calibration procedures 1000DF00479 Issue 2 38 50 Maintenance continued Cleaning and Storage Cleaning the pump Before the transfer of the pump to a new patient and periodically during the use clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution A soft bristled brush may be used to clean narrow areas Before cleaning always switch off and disconnect from the AC power supply Do not allow liquid to enter the casing and avoid excess fluid build up on the pump Do not spray fluid directly into any connector and before cleaning verify that the RS232 connector is covered Use light pressure when cleaning pressure transducer and air in line detector areas of the pump Do not use aggressive cleaning agents as these may damage the exterior surface of the pump Do not steam autoclave ethylene oxide sterilise or immerse this pump in any fluid Recommended cleaners are e Bleach solution 1096 v v e Vesphene e Manu Klenz e Warm Water Do not use the following disinfectant types e phosphoric acid Foamy Q amp A e aromatic solvents naphtha paint thinner etc e chlorinated solvents Trichloroethane MEK Toluene etc ammonia acetone benzene xylene or alcohol other than as specified above Sto
59. lugged Primary Flow Detected During Secondary Rechargeable nickel cadmium A single channel pump operates for 4 hours nominal and a dual channel pump operates for 3 hours nominal under following conditions new fully charged battery ambient room temperature 23 4 C 73 7 F resistance monitoring modes rate 100 ml h ona single channel pump and 50 ml h on each channel of a dual channel pump Battery run time is affected by operating mode rate monitoring options and back pressure Maximum incremental volume in case of single point failure does not exceed 1 0 ml at 999 9 ml h 7131 7231 Depth 127mm 127mm Height 218mm 218mm Width 193mm 267mm Weight 3 0 kg 3 8kg Without pole clamp Without power cord Time to Alarm Time to Detect Downstream Occlusion Monitoring Options minutes Resistance and High Resistance 25 600 10096 10096 Threshold Settings 25 mmHg 600 mmHg Dest 95 9 Ca 2 1 When occlusion alarm pressure limit is set to maximum threshold setting maximum infusion pressure generated into a hard occlusion at 25 ml h is 11 6 3 9 psi Bolus Volume Bolus Volume released upon Monitoring Options correcting Downstream Occlusion ml Pressure Resistance and High Resistance 25 600 100 100 Threshold Settings mma 25 mmHg 600 mmHg Testing performed using Model 72003 infusion set at 20 4 C 68 8 F Time to Occlusion and Bolus Volume data tested to standards defined in AAMI ID26 199
60. lustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump These settings and values are for illustrative use only The complete range of settings and values are detailed in the specifications section Conventions used in this manual H Important Information Wherever this symbol is shown an Important note is found These notes highlight an aspect of use that is important to know about Defined terms The following table identifies the defined terms used throughout this document for certain products and product features 1000DF00479 Issue 2 2 50 AC power indicator Rate Display s p P S A a n Uhr ml hr m KVO OPT HLD PRI SEC i PRI SEC HLD OPT kvo a RUN HOLD Pumping Mechanism Pressure Transducer E as A Air in line Detector Main Display Lower Display Air in line Arm Panel Lock Keypad Flow Sensor Receptacle s RS232 Connector iN lt Pole Clamp AC Power Connector t 1000DF00479 Issue 2 3 50 Controls and Indicators Controls Numeric Keypad keys Enters changes values Channel Select keys and indicators Select channel A or B Lights to indicate which channel is selected Split Screen key Di
61. m A very high pressure exists in infusion set while baseline is being set Pressure Baseline feature is on If set is loaded Eject set wait 5 seconds and then reload set If no set is loaded Load set wait 1 minute and then eject set Wait 5 seconds and then reload set Pump has calculated a rate less than 0 1ml h Verify and re enter settings Close latch fully to left Notify Biomedical Engineering department If desired press continue soft key to temporarily bypass reminder Verify and re enter settings Baseline remains set until a new manual baseline is set pump is turned off or latch is opened Remove source of high pressure and repeat setting of pressure baseline OkEntry Attempt was made to go to another page before Verify all parameters are correct and press ok pressing ok soft key soft key Panel Locked A key was pressed Turn panel lock off to access panel controls Panel lock feature is on 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 SET PRESSURE BASELINE function was selected while running Pressure Baseline feature is on Place on Hold to Set Pressure Baseline Press and Hold Key to Turn Off Pressure Limit XXX mmHg XXX represents configured maximum pressure An elevated pressure was present in fluid path when pressure baseline was established This may reduce maximum available pressure range Pres
62. mmed as a Basic SEC or Guardrails SEC drug When the secondary VTBI reaches zero an audio tone sounds if enabled Secondary Complete message displays briefly and the primary infusion rate automatically resumes When the pump is programmed and delivering in the secondary mode the primary infusion is temporarily stopped and fluid is drawn from the secondary container Delivery from the primary container resumes when the fluid level in the secondary infusion setis level with the fluid in the primary container Primary infusion must be on hold to program secondary infusion A secondary infusion may be programmed only after a primary IV Fluid that supports secondary mode or a primary Basic Infusion has been programmed The secondary key is unavailable for selections that have been designated as inappropriate for secondary delivery Pressing the SEC key after programming a fluid that does not support secondary infusions results in a message Secondary not allowed with this fluid Secondary 1 Loadthe primed set See Loading the Infusion Set for instructions container 2 Preparethe secondary infusion using a secondary solution container and the check valve primary set lower the primary container See illustration right 3 Prime the secondary infusion set in accordance with the set Directions for Hanger CA Use 4 Attach secondary infusion set to the upper Y site of the primary infusion set 5 Fully open the regulating clamp on the s
63. n Unit 2 Oude Molen Business Park Oude Molen Road Ndabeni Cape Town 7405 South Africa Tel 27 0 860 597 572 Tel 27 21 510 7562 Fax 27 21 5107567 Compliance This system complies with part 18 of the FCC Rules Operation is subject to the following 2 conditions This system may not cause harmful interference This system must accept any interference received including interference that may 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 This system has been tested and found to comply with either the limits for a Class B digital pump without Model 180 Flow Sensor or as a Class A digital pump 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 itis not installed and used in accordance with the applicable directions for use it may 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 r
64. n 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 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 1 0 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 may 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
65. nd 59 Verify and re enter settings minutes or is less than 1 minute Verify Time Internal clock needs to be reset following depleted Press change soft key battery Re enter settings and press ok soft key to confirm Soft Limit Programmed parameter is outside Soft Limit for If it is clinically appropriate and necessary to that care area override Soft Limit press yes soft key Otherwise press no soft key and enter new value within limit Important Prior to overriding a Soft Limit prompt confirm the infusion parameters are correct Programmed parameter is outside Hard Limit for Use numeric keys to enter a new value then that care area press ENTER key Invalid Keypress During Programming The following Prompts may 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 may be seen Dose Rate Running Loading Dose Running Multi Dose Running Multi Step Running Pri Running Sec Running or Timer Running Multi Dose program Resuming Previous Programming When a pump has been powered off then on again previous parameters may be preserved if Current Profile is accepted and New Patient No is selected The following prompts may be seen Return to Dose Rate Return to Loading Dose Return to Multi Dose Return to Multi S
66. nnel is in alarm and has stopped infusing 1000DF00479 Issue 2 4 50 Symbol Definitions Labelling Symbols Defibrillation proof Type CF applied part Degree of protection against electrical shock Protected against vertically falling drops of water Ce Device complies with the requirements of Council Directive 93 42 EEC as amended by 2007 47 EC Not for Municipal Waste Functional Earth RS232 Nurse Call Connector Canadian and U S Certification Mark Products bearing this mark have been tested and certified in accordance with applicable U S and Canadian electrical safety and performance standards U S Certification Mark Products bearing this mark have been tested and certified in accordance with applicable Federal Communications Comission Guidelines Flow Sensor receptacle Channel A Flow Sensor receptacle Channel B Authorised representative in the European Community 1000DF00479 Issue 2 5 50 Display Features 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 A B OPTIONS the backlight up again DEE fat Dose 0 8 mg kg h C4 Conc 100 mg 100 mL j Wt 70 kg Appearance of lines and or dots that remain on constantly menu when the pump is powered on may indicate improper ok m m functioning of the Main Display Although the pump is 6 A A functioning p
67. nsure that the infusion is progressing correctly and no alarms are operating Electromagnetic Compatibility and Interference This pump is protected against the effects of external interference including high energy radio frequency emissions magnetic fields and electrostatic discharge for example as generated by electrosurgical and cauterising equipment large motors portable radios cellular telephones etc and is designed to remain safe when unreasonable levels of interference are encountered In some circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv or by radio frequency radiation close to or above 10v m If the pump is affected by this external interference the pump will remain in a safe mode the pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms Should any encountered alarm condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel H This pump is a CISPR 11 Group 1 Class A device when the model 180 Flow Sensor is used and a CISPR 11 Group 1 Class B device without the use of the model 180 Flow Sensor The pump uses RF energy only for its internal function in the normal product offering In a domestic environment this system may cause radio interference Reorienting relocating or shiel
68. oft key no upstream flow detected Flow has been obstructed Check to see if container is empty flow sensor is mispositioned between container and pump or clouded tubing is kinked or air vent is closed Verify correct when using a flow sensor set connections and open fluid path Press run soft key to restart infusion Note Infusing fluids which form smaller drops through a 60 drops ml set at high rates may result in a No Upstream Flow Detected alarm This is because the small rapidly falling drops form a continuous stream which does not trigger the flow sensor In this event unplug the flow sensor from the pump occlusion downstream Pressure in infusion set has Check infusion set for probable cause such as kinked tubing exceeded a pressure alarm closed stopcock high resistance catheter Press run soft key to threshold or Resistance has restart infusion reached 100 occlusion upstream Flow has been obstructed Check infusion set for probable cause such as kinked tubing between fluid container and closed clamp Verify that blue thumb clamp on Flow Regulator pump s pressure sensor has moved to open up position If not reload set Press run soft key to restart infusion primary flow detected during Pump detected flow from Verify that flow sensor is on Primary infusion set and that set up secondary primary container during is correct secondary infusion NOTE Alarm can only occur when using optional flow sensor Set has
69. ommends that the battery be fully charged discharged recharged using the refresh cycle before placing the pump in use The pump will automatically operate from its internal battery if the pump is switched on without being connected to the power supply Should the pump fail to perform correctly replace in its original protective packaging where possible and contact a qualified service engineer for investigation Pole Clamp Installation The uniquely designed pole clamp adapts to a wide variety of surfaces such as poles bed rails to provide greater versatility and to simplify transports It features 360 rotation in 909 increments ergonomically designed knob accommodates diameters from 15 to 35 millimetres Changing Pole Clamp Orientation 1 Pressand hold rotation lever 2 Reposition clamp 3 Release lever at desired position Lever The illustrated pole clamp knob may not reflect the knob in use on the pump When using multiple pumps care should be taken to evenly distribute the pumps to ensure stability To ensure proper occlusion detection do not operate the pump tilted back more than 45 from the upright position 1000DF00479 Issue 2 10 50 Getting Started continued Priming an Infusion Set When priming Ensure patient is not connected Ensure air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime
70. on 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 1000DF00479 Issue 2 41 50 Trumpet and Start Up Curves continued Pressure Mode Pressure Mode Start up at 0 1 mL h initial om 0 08 0 06 0 04 0 02 0 00 0 02 mL h 0 20 40 60 80 20 Time min Pressure Mode Trumpet Curve at 0 1 mL h initial 0 5 10 15 20 25 30 Observation Interval min Pressure Mode Trumpet Curve at 0 1 mL h 48 hr ZS o e CG o00 6 Flow Rate Error 96 0 5 10 15 20 25 30 Observation Interval min Legend ll Maximum rate error Overall rate error Minimum rate error 1000DF00479 Issue 2 Pressure Mode Start up at 1 mL h initial mL h 0 20 40 60 80 100 120 Time min Pressure Mode Trumpet Curve at 1 mL h initial Flow Rate Error 0 5 10 15 20 25 30 Observation Interval min Pressure Mode Trumpet Curve at 1 mL h 48 hr Flow Rate Error 96 0 5 10 15 20 25 30 Observation Interval min 42 50 Trumpet and Start Up Curves continued Pressure Mode continued mL h Flow Rate Error 96 a Flow Rate Error Pressure Mode Start up at 25 mL h initial o N o D o o 2 o 100 120 Time min Pressure Mode Trumpet Curve at 25 mL h initial a
71. on or other infusions through a common set is present in infusion set at this time For best results verify set outlet for example stopcock is located at patient s heart level before continuing with next step Press ok soft key Verify pressure readout is 0 zero mmHg To start infusion press RUN HOLD key Oo Lv Ut de UU NI To return to the normal screen without setting the baseline press return soft key 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 The pressure baseline calibration remains in effect until the pump 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 pump 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 1000DF00479 Issue 2 25 50 Options continued Monitoring Options continued Pressure Trend Graphs 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
72. onnector housings and have a 100 coverage braid foil shield attached to the connector housings around the signal conductors with the cable jacket Connecting to a Computer Press OPTIONS key To advance to next page press page soft key Press Computer Link soft key Press Monitor soft key Press ok soft key Connect an RS232 cable from hospital computer to RS232 port on pump back panel During communication between host computer and pump MNTR Monitor Mode appears in lower LCD e If communication is interrupted MNTR flashes for 60 seconds Ov urs uM Disconnecting from a Computer Press OPTIONS key To advance to next page press page soft key Press Computer Link soft key Press Off soft key Press ok soft key Disconnect RS232 cable from RS232 port on pump back panel Sr Sr uS M NS Use of any accessory or cable other than those specified may result in increased emissions or decreased Pump immunity The protective cover over the RS232 connector must remain in place when not in use Only equipment that complies with IEC EN 60601 1 or UL 1069 approved medical or hospital signaling equipment should be connected to the RS232 connector 1000DF00479 Issue 2 40 50 Trumpet and Start Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND START UP CURVES In this pump as with all infusion systems the action of the pumping mechanism and variations in individual administration sets cause short term fluctuations i
73. parameters are correct and press run soft key or RUN HOLD key to start infusion 1000DF00479 Issue 2 18 50 Options continued Loading Dose This feature allows an initial infusion rate to be set up for a specific volume automatically followed by a maintenance rate primary settings from the same container If delivering a bolus dose of medication to load prior to the start of a continuous infusion see Primary Infusion With Guardrails Suite MX Protection Bolus Dose The primary VTBI and VI include the loading dose volumes When the loading dose VTBI reaches zero a transition tone sounds if transition tone feature is enabled Load Dose Complete message displays briefly and the primary settings automatically take effect Verify the primary mode parameters 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 3 Press Loading Dose soft key Loading Dose infusion rate is highlighted 4 If current value is appropriate press ENTER key or to enter a new infusion rate use numeric keypad and press ENTER key 5 Loading Dose VTBI is highlighted If current value is appropriate press ENTER key or to enter a new VTBI use numeric keypad and press ENTER key 6 To start loading dose infusion press RUN HOLD key 7 Tobriefly view current profile press DN soft key 8 Tobriefly view primary settings Pri Rate Pri VTBI Total VI during load
74. pointing up or below pointing down the rate 1000DF00479 Issue 2 6 50 Operating Precautions H Use only sets dedicated for use with the pump The use of any other set may cause improper operation resulting in an inaccurate fluid delivery or other potential hazard It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use When combining several apparatus and or instruments with infusion sets and other tubing for example via a 3 way tap or multiple infusion the performance of the pump may be affected and should be monitored closely H Uncontrolled flow may result if the infusion set is not properly isolated from the patient i e closing a tap in the set or activating an in line clamp roller clamp The infusion set may be fitted with an in line clamp which can be used to occlude tubing in case it is required to stop fluid flow H The pump is a positive pressure pump which should use infusion sets fitted with Luer lock fittings or equivalent locking connectors To infuse from a burette close the roller clamp above the burette and open the clamp on the vent on top of the burette Before operating the pump verify the infusion set is free from kinks and installed correctly in the pump H Discard infusion set if the packaging is not intact or the protector cap is detached
75. ptional hospital defined and editable starting value for time may already be entered or to enter a value use numeric keypad to enter hours 0 99 then minutes 0 59 Press ENTER key to accept each entry Se o o ch 0 Time can be entered to calculate rate or if rate entry is desired press rate ma softkey It changes to EH time indicating that rate may be entered 12 Verify that all parameters are correct and press ok soft key 13 Verify that all parameters are correct and press run soft key or RUN HOLD key to start infusion 14 To briefly view setup parameters therapy total dose concentration patient weight or BSA current profile from RUN HOLD page or during a running infusion press DN soft key Making Changes During Intermittent Infusion Intermittent infusions must be paused to change parameters Rate VTBI or Time or to clear VI Press RUN HOLD key for desired channel Press soft key next to parameter to be edited To enter a new value use numeric keypad To reset volume infused to 0 0 ml press CLEAR or 0 zero key To accept new value press ENTER key Ui Wen a rate Olm indicating that time may be entered LJ Rate can be entered to calculate time or if time entry is desired press E time softkey It changes to 1000DF00479 Issue 2 16 50 Secondary Infusion This mode is designed to support automatic secondary infusions piggybacking in the same channel A secondary infusion can be progra
76. r All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied CareFusion Alaris Products will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion Refer to the Technical Service Manual for access to diagnostic and configuration modes for technical service The Technical Service Manual is available in electronic format on the World Wide Web at www carefusion com alaris intl A username and password are required to access our manuals Please contact a local customer services representative to obtain login details INTERVAL ROUTINE MAINTENANCE PROCEDURE As per Hospital policy Thoroughly clean external surfaces of the pump before and after prolonged period of EE At least once per year Inspect AC power supply plug and cable for damage Refer to TSM for identification j Perform functional tests as outlined in the Technical Service Manual of parts Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging calibration procedure are standard SI The International System of Units units 1 Please refer to Technical Service Manual for calibration procedures The units of measurement used in the Battery Operation The Battery Management System incorporates features which enhance battery main
77. ring the pump If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged Store in a clean dry atmosphere at room temperature and if available employ the original packaging for protection Once every 3 months during storage carry out functional tests as described in the technical service manual and ensure that the internal battery is fully charged Cleaning and storing the infusion set The infusion set is a disposable single use item and should be discarded after use according to hospital protocol Cleaning the Flow Sensor Before the transfer of the flow sensor to a new infusion set and periodically during use clean the flow sensor by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Ensure the connector does not get wet Dry flow sensor before use Flow sensor should be routinely cleaned by running warm water over it while actuating slider and then thoroughly dried After cleaning the sensor should be allowed to dry fully prior to use The plug of the flow sensor must not be immersed in water as damage will occur Disposal Information on Disposal for Users of Waste Electrical amp Electronic Equipment This X symbol on the product and or accompanying documents means that used electrical and electronic products should not be mixed with household waste If you wish to discard electrical and el
78. roperly return it to qualified service personnel Rate Display Indicates current infusion rate s in ml h Flashes to indicate hold or alarm condition and when in KVO mode Indicates which mode pump is in OPT Optional Modes PRI Primary HLD Hold SEC Secondary KVO Keep Vein Open LED rate display is easily viewed from a distance Lower Display am mp mi The lower LCD display is backlit for easy viewing The display dims when G OL D operating on battery power as an energy saving feature CEJ Screen Icons BATTERY POWER GAUGE icon Indicates approximate battery time remaining under current infusing condi ea tions To ensure a more accurate gauge reading review the remaining battery run time 5 minutes after starting an infusion The battery gauge does not represent the battery time remaining when the pump is turned off CN PANEL LOCK icon Indicates that panel lock is on 4 vm m Audio Volume Indicator Indicates audio volume for alarms and alerts Low m Medium High 4m ER Computer Mode Indicator Displayed if pump is in computer monitor mode G D Pump ID Label Characters are entered to identify selected Profile or configuration ownership location etc EA Hourglass icon Flashes to indicate timer is counting down to start of dose in Multi dose mode TTT I I I limit for that profile SOFT LIMIT icon Indicates the pump is running at a rate above
79. rs may not be edited during bolus infusion If new parameters are desired select New Bolus from the Bolus menu Delivering a Bolus Prior to Beginning an Infusion 1 On VTBI and VI setup page press Bolus soft key 2 Anoptional hospital defined and editable starting value for bolus dose may already be entered or to enter a value use numeric keypad then press ENTER key 3 Anoptional hospital defined bolus dose administration rate may have been used to calculate an editable Time in minutes 1 99 to deliver programmed bolus dose or to enter a Time value use numeric keypad then press ENTER key 4 Verify parameters are correct and press ok soft key Verify that all parameters are correct then press run soft key or RUN HOLD key to start infusion 6 When bolus dose completes an audio tone sounds and Bolus Dose Complete briefly displays and infusion automatically transitions to continuous rate n Delivering a Bolus During an Infusion Press OPTIONS key Press Bolus soft key Press New Bolus soft key or to repeat a previous bolus press Repeat Last Bolus soft key An optional hospital defined and editable starting value for bolus dose may already be entered or to enter a value use numeric keypad then press ENTER key 5 Anoptional hospital defined bolus dose administration rate may have been used to calculate an editable Time in minutes to deliver programmed bolus dose or to enter a value use numeric keypad then press ENTER key Ver
80. s ml set at high rates may result in a No Upstream Flow Detected alarm This is because the small rapidly falling drops form a continuous stream which does not trigger the flow sensor In this event unplug the flow sensor from the pump Do not use solvents or cleaning agents Damage to plastic parts of the flow sensor could occur When using flow sensor correct placement is essential for proper operation Some infusion set drip chambers have a flange at top to which flow sensor can be attached Attachment on flange ensures proper placement Upper surface of flow sensor should be slightly below drop forming orifice but above level of fluid in drip chamber Ensure drip chamber is at least 2 3 full and sensor optics are clean Fluid level in drip chamber must be checked re established after each empty container condition 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 s If the flow sensor option is in use VTBI can be turned off by selecting VTBI pressing CLEAR and then ENTER keys or Primary VTBI can be deleted from the primary mode setup page 1000DF00479 Issue 2 32 50 Configurable Settings With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice data set must be uploaded to enable the Profiles feature If the Profiles feature is not enabled off or
81. splays information for both channels when both channels are infusing Audio Volume key Sets audio volume for alarms alerts and KVO tone Press key to adjust volume Audio volume level displays in the lower LCD display H Pump can be configured to enable only Medium and High or only High audio volume levels Clear Clear key Clears selected numeric value LON Enter key Accepts value or selection entered pw Power key Turn channel s on and off OPTIONS Options key Accesses additional features Silence key Silences audible alarm or alert for 2 minutes message remains on screen New alarm or alert reinstates the audible tone eri Primary key Selects Primary mode Channel must be selected if applicable sec Secondary key Selects Secondary mode Channel must be selected if applicable AA Run Hold key Start and stop infusion on selected channel Channel must be selected to restart if applicable 60 Panel Lock key Located behind the handle this key helps prevent unauthorised changes to the pump settings EY Softkeys Access main display menu options A soft key is active if there is a tick mark I next to the key Indicators Infusing indicator s Indicates a channel is infusing Power indicator When illuminated Green the pump is connected to an AC power supply and the battery is being charged When flashing Amber the pump is running on the internal battery GE Alarm indicator s Indicates a cha
82. stream pressure or flow resistance over time Pressure Baseline to provide a starting point from which to measure changes in system pressure Infusion sets catheters and applications create various levels of resistance to flow Monitoring mode options are available to meet each clinical need Resistance designed to monitor IV infusion set site resistance providing optimum sensitivity for most IV applications High Resistance designed to monitor IV infusion set site resistance with optimum sensitivity where higher resistance catheters are used Adjustable Pressure designed to monitor IV infusion set 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 infusion set site pressure and alarm based on a fixed pressure limit Precision Flow in fixed and adjustable pressure modes the Pump provides enhanced flow continuity at rates below 50 ml h Selecting Monitoring Option For dual channel pumps select the desired channel as necessary The bar graph and numeric displays are not available when the split screen is displayed 1 Press OPTIONS key 2 Press Monitoring Options soft key 3 Press soft key for Resistance High Resistance or Adjustable Pressure 4 Press ok soft key Display automatically returns to normal opera
83. supply or a battery The pump does employ an internal short duration battery 48 50 Compliance continued Guidance and Manufacturer s Declaration Electromagnetic Immunity LIFE SUPPORT Equipment The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should ensure that it is used in such an environment IEC EN 60601 1 2 Compliance Test Level Level Electromagnetic Environment Guidance Immunity Test Portable and mobile RF communications equipment should be used no closer to any part of the pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance IEC EN 61000 4 6 3 V rms 10V rms Conducted RF 150 kHz to 80 MHz Note 3 VP 80 MHz to 800 MHz 3 V m IEC EN 61000 4 3 80 MHz to 2 5 GHz Radiated RF VP 80 MHz to 800 MHz VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m a Field strengths from fixed RF transmitters as determined by an electromagnetic site survey b should be less than the compliance level in each frequency range c Interference may occur in the vicinity of equipment marked with the following symbol Dei Note 1 At 80 MHz and 800 MHz the higher frequency range appli
84. sure 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 1000DF00479 Issue 2 29 50 Place pump on hold before performing manual SET PRESSURE BASELINE operation POWER was pressed Press and hold POWER until display turns off Reload infusion set and verify no obstruction exists which could cause excess pressure e If Pressure Baseline feature is on repeat manual setting of pressure baseline otherwise e Restarting infusion automatically sets pressure baseline Choose a pressure alarm limit that is less than or equal to configured maximum pressure Alarms Alerts and Prompts continued Prompts continued Response Pressure Unstable Cannot Excessive variation in pressure due to motion flow Reduce or temporarily remove sources of Set Baseline from other pumps or blood pressure prevents variation while performing manual baseline accurate setting of pressure baseline setting operation Pressure Baseline feature is on Program Lost Re Enter Pump detected a memory or power failure Existing Press continue soft key and re enter all infusion Settings operating parameters were erased settings Configurable options are not affected Rate Out of Range Pump has calculated a rate less than 0 1 ml h Verify and re enter settings Set Must Be Loaded Flow Regulator segment is not loaded in
85. tenance in order to maximize the life of the battery reduce associated costs and increase pump availability The system provides Green lights when pump is plugged in Amber flashes when pump is operating on battery power e Automatic battery power if pump 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 pump in use Reference the Technical Service Manual for detailed information on the refresh cycle The battery recharges whenever the pump 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 the pump is connected to AC power whenever possible including when it is powered off or stored Following certain battery depleted conditions it is necessary to reset the internal clock so the COI Reporter data integrity is maintained Test Routines The test routines are designed to allow confirmation of many of the pump functions defaults and calibrations without requiring interna
86. tep or Return to Secondary 1000DF00479 Issue 2 30 50 Alarms Alerts and Prompts continued Alerts Counter The pump keeps a running count of Guardrails Alerts that occur that can be viewed with the Alerts Counter feature 1 Press OPTIONS key 2 Press Alerts Counters soft key 3 Toreturn to main display press return soft key To clear counter reset all values to zero press clear soft key To view second event counter page press page soft key Definitions GR Alerts GR Starts Log 96 Full New Patients Overrides Soft Alerts Total Starts Total number of Hard Limit and Soft Limit Guardrails alerts that occur Total starts when a Guardrails drug or Guardrails IV fluid is selected GR Start counter also increments if a rate or dose rate change occurs during a running infusion A transition to KVO rate is not counted as a start CQI log retained by pump can hold up to 300 Guardrails alerts and resolutions snapshots The full indication represents percentage of 300 available logged snapshots used Log always retains most recent 300 snapshots therefore even if this indication is 10096 full subsequent Guardrails alerts and resolution snapshots are stored and oldest ones are deleted to make space for newer ones Total number of new patients or profiles selected Counter increments when yes to New Patient screen prompt or a different profile at pump power up is selected Total number of Soft Limit Gu
87. terval from start of one dose until start of next use numeric keypad Press ENTER key Verify that all parameters are correct then press ok soft key If Dose Complete Alert Option is enabled DOSE COMPLETE ALERT OPTION page appears To select On or Off use soft keys Tocontinue programming press ok soft key To start first dose immediately press ok soft key Then press run soft key or RUN HOLD key to start infusion To delay start of first dose enter time hours and minutes using numeric keypad and ENTER key Then to advance to timer hold page press start timer soft key Changing Time Interval Until Next Dose Row Press stop timer soft key To select a value for editing press relevant soft key To enter new value use numeric keypad Press ENTER key When editing is complete press start timer soft key Resuming an Interrupted Multi Dose Pw NM gt Press yes soft key on the Return To Multi Dose page To accept set up parameters press Review Resume soft key To continue press ok soft key If infusion was in progress when interrupted press run soft key or RUN HOLD key to resume infusion If infusion was NOT in progress when interrupted edit time to delivery of next dose as necessary then press start timer soft key Quitting Multi Dose The channel must be on hold or the last dose complete 1 2 Press menu soft key To return to primary set up page press Quit Program soft key 1000DF00479 Issue 2 20 50
88. the hospital data set Downstream Occlusions which occur in Pressure or Resistance modes are indicated by a tick mark I at the top of the trend screen To view graph 1 Dual channel pumps Select desired channel as necessary Trend graph is not available while split screen is displayed Press OPTIONS key Press Pressure Trend soft key To change graph time frame press time soft key PwD A solid horizontal line represents current pressure alarm limit level Gaps in graph may indicate non infusing conditions such as turned off on hold in alarm 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 A tick mark I at top of graph indicates an occlusion To clear graph 1 Toclear graphed data press clear soft key 2 Press ok soft key To return to normal operation 1 Press return soft key SmartSite Needle Free System Instructions SmartSite Needle Free Valve is designed to permit safe gravity flow and automated flow injection and aspiration of fluids without the use of needles by utilising Luer lock and luer slip connectors Precautions Discard if packaging is not intact or protector caps are unattached Needle Free Valve contraindicated for blunt cannula system DIRECTIONS Use Aseptic Technique 1 Prior to every access swab top of Needle Free Valve port with 70 Isopropyl alcohol 1 2 se
89. ting screen If Resistance option is selected Resistance displays below bar graph while infusing If High Resistance option is selected 96 Hi Resist displays below bar graph while infusing If Adjustable Pressure option is selected pressure system accuracy can be enhanced by ensuring no occlusion or other pressure source exists in infusion set when activating RUN HOLD Each time the pump is turned on verify and or set the monitoring mode If the monitoring mode resistance alert and or pressure alarm limit are not verified the pump may not be operating with the desired occlusion detection parameter s High Resistance and Resistance alert limit may be adjusted using the soft keys located below the arrow symbols Pressure alarm limits may be adjusted when operating in Adjustable Pressure mode using the soft keys located below the arrow symbols Maximum pressure limit settings may be configured by qualified service personnel 1000DF00479 Issue 2 22 50 Options continued Monitoring Options 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
90. ue 2 17 50 Promoting Basic Infusion When the Profiles feature is set to OFF or when no data set has been transferred to the Pump Guardrails Suite MX protection is not available and this section does not apply A basic infusion may be promoted to a continuous drug infusion or a fluid infusion with Guardrails Suite MX protection while infusing A basic infusion may not be promoted to an intermittent drug If an intermittent drug is selected a Pri Running message is displayed Infusion must be running in the Basic Primary Mode Select desired channel as necessary Press Options key Press Guardrails Menu soft key Press New Guardrails Drug or New Guardrails Fluid soft key as required Set up New Guardrails Drug or New Guardrails Fluid as per previous instructions Verify that all parameters are correct and press ok soft key or ENTER key as appropriate Ov Ur ds biz Dose Rate Calculator When the Profiles feature is set to OFF this feature allows the clinician to select a drug name from a pre set list or to select a generic calculation feature by selecting Drug to calculate drug parameters for drugs not on the list If the preset list is disabled in the pump configuration settings then only generic calculation is available Parameters are calculated automatically based on concentration weight entry if required rate or dose entry Press OPTIONS soft key Press Dose Rate Calculator soft key Press Enter New Program
91. um These features are configured only within a hospital defined data set 1000DF00479 Issue 2 34 50 Configured Options Record Configurable Options Enter the pump specific information for your records on a copy of this page Air in Line Accumulator lon Air in Line threshold 100 ul Air in Line Reset O Transition Tone lon Audio Volume Low Med Hi Med Hi Hi Configuration Name Monitoring Options Trends jon Manual Pressure Baseline Pressure Alarm Pressure Display jon fone Pressure Limit Initial Pressure Limit Maximum Default Resistance Alert Resistance Alen DENEN Resistance Display Resistance Pressure Setting KVO Rate 5 ml h Bolus Off Dose Rate Calculator Off Loading Dose Multi Dose Multi Dose Alert Multi Step Panel Lock Rate Maximum peut Range If a new logic pcb is installed or the pump is set to factory defaults the pump defaults to North America English Hospital Name Serial No Software Version Approved by Configured by Date Date 1000DF00479 Issue 2 35 50 Infusion sets Alarms Battery Critical Volume Dimensions Nominal Downstream Occlusion Use only infusion sets for Alaris SE Pump Accumulated Air In Line Key Stuck Set Out Air In Line Latch Open Set Up Time Exceeded Battery Depleted No Upstream Flow Detected Pump Malfunction Channel Malfunction Occlusion Downstream Hold Time Exceeded Occlusion Upstream Computer Link Failure Flow Sensor Unp

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