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Alaris Signature Gold Infusion Pump User Manual - Med-E

Contents

1. LL 96 ADDITIONAL FEATURES Flow Sensor The optional Flow Sensor notifies users of empty containers and or upstream occlusions A handle cap accessory is available for storing the flow sensor when not in use NOTE Ifa flow sensor is not connected to the instrument 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 Flow Sensor Connectors connector on back of Instrument o0000f0 sD 2 Attach flow sensor to upper portion of drip chamber e When using flow sensor correct placement is essential for proper operation Drip chambers of some administration sets have a flange at top to which flow sensor can be attached Attachment on flange will ensure proper placement Upper surface of flow sensor should be slightly below drop forming orifice but above level of fluid in drip chamber Ensure fluid level in drip chamber is at fill line and sensor optics are clean NOTE Fluid level in drip chamber must be checked re established after each empty container condition e When using flow sensor option while ambulating or transporting a patient from one area to another use care to avoid excessive swinging of solution container s ADDITIONAL FEATURES 97 gt Zi JJ mi YN IWNOILIGGV Flow Sensor Continued 3 Attach flo
2. Multi Dose Program Continued Resuming an Interrupted Multi Dose Program Continued 3 To access setup parameters press Review Resume soft key e f infusion was in progress when interrupted proceed to If Intusion Was In Progress When Interrupted section e f infusion was not in progress when interrupted proceed to If Infusion Was Not In Progress When Interrupted section If Infusion Was In Progress When Interrupted 1 To approve and advance to main hold page press ok soft key 2 To resume infusion press p Or run soft key If Infusion Was Not In Progress When Interrupted 1 Press ok soft key 2 Edit time to delivery of next dose as necessary 3 To begin timer s countdown to delivery of next dose press start timer soft key 86 ADVANCED OPERATIONS Multi Dose Program Continued Quitting Multi Dose Program The channel must be on hold or the last dose complete 1 Press menu soft key 2 To return to primary setup page press Quit Program soft key NOTE Primary setup page parameters may be different from those of the Multi Dose program Verify all settings prior to resuming an infusion oy tol fare DIONS This feature allows the clinician to set up an Initial infusion rate WARNING for a specific volume automatically followed by a maintenance This mode is useful for loading a rate primary settings from the same c
3. gt lt a AL EY alr St lt Air in Line and Accumulated Air in Line The Air in Line Detection System provides clinicians the ability to detect inappropriate amounts of air in the IV line The instrument is configurable to allow single bubble or accumulated air detection Accumulated air detection is based on measurement of the average percentage produced by small air bubbles passing the detector Air is detected by an emitter Air in Line arm which rotates into position as the latch is closed A receiver Air in Line Detector opposite the arm and just below the Pumping Mechanism sends the Air in Line information to the main processor Qualified biomedical personnel may configure one of four possible sensitivity levels The instrument is also configurable to permit the operator to clear reset any air registered in the instrument s memory NOTE Ensure that the tubing is properly inserted into the air detector to avoid false alarms The tubing may be reshaped to ensure optimum contact with the sensors Periodically clean the a Air in Line Detector Air in Line Detector to ensure a clear signal can be received refer to Alr in Line Arm Cleaning section of this document BASIC SYSTEM OPERATION 27 Air in Line and Accumulated Air in Line Continued Single or Accumulated Air Bubble Detection NO Reset Feature 1 To place channel on hold press hold
4. Radio Frequency Interference Operating the instrument near equipment which radiates Use of accessories or cables other high energy radio frequencies electrosurgical cauterizing than those specified may result in equipment portable radios cellular telephones etc may degraded electromagnetic cause false alarm conditions If this happens reposition the compatibility performance of this instrument away trom the source of interference or turn off device the instrument and manually regulate the flow with the AccuSlide Flow Regulator regulating clamp BASIC SYSTEM OPERATION 15 Preparing an Infusion Preparing Primary Solution Container Prepare the primary solution container in accordance with the manufacturer s directions for use Preparing Primary Administration Set Use only an ALARIS Medical Systems 72 Series administration SCL e Slide AccuSlide Flow Regulator thumb clamp down until sihnumb Clamp an audible click verifies it is in Tully closed position AccuSlide Flow Regulator e Spike solution container e Fill drip chamber to 2 3 full NOTE Open the vent cap on the spike if the container requires venting e Invert AccuSlide Flow Regulator Slide up to open for priming e To prime set slide AccuSlide Flow Regulator thumb clamp to open position e When priming is complete close AccuSlide Flow Regulator clamp Verity no
5. e Adjustable Resistance Alert to provide an early warning of increases in downstream flow resistance v m S m v GADNVACV e Adjustable Pressure Alarm to provide an early warning of increases in downstream pressure e Trend Graph to display downstream pressure or flow resistance over time e Pressure Baseline to provide a starting point from which to measure changes In system pressure Monitoring Options General IV lines catheters and applications create various levels of resistance to flow Monitoring mode options are available to meet each clinical need e Resistance designed to monitor IV line site resistance providing optimum sensitivity for most IV applications e High Resistance designed to monitor IV line site resistance with optimum sensitivity where higher resistance catheters are used Resistance Monitoring ADVANCED OPERATIONS 41 Dynamic Monitoring System Continued Monitoring Options General Continued e Adjustable Pressure designed to monitor IV line site pressure and provide user adjustable pressure alarm limits Used for Precision Flow mode or for high resistance systems such as infusion through transducers into dialysis systems and through highest resistance catheters e Pressure designed to monitor IV line site pressure and alarm based on a fixed pressure limit penenang NOTE Precision Flow in fixed and adjustable pressure modes th
6. PRIMARY FLOW DETECTED Instrument detected flow from Verity Flow sensor is on U L DURING SECONDARY primary container during primary line Primary set has Zu secondary infusion check valve Secondary SNFA A Alarm ae o4 infusion is complete underfilled gt NOTE Alarm can only occur solution container Secondary when using optional flow sensor set fluid path is not blocked e Secondary settings are correct Press run soft key to restart infusion Pri Running or was pressed while Channel must be on hold to Prompt channel was running in primary change modes mode Program Lost Re Enter Settings Instrument detected a memory Press continue soft key and Prompt or power failure Existing reenter all infusion settings operating parameters have been erased NOTE Configurable options are not affected Rate Out of Range Instrument has calculated a rate Verify and reenter settings Prompt less than 0 1 mL h Resistance Alert IV line resistance has reached Check downstream line and site Alert preset alert level Raise resistance alert level if Resistance Alert feature Is app Opiate Ol on Return To Dose Rate Channel was turned off during a Press yes soft key to return to Prompt Dose Rate program NEW Dose Rate program or press no PATIENT no was selected soft key to return to primary during start up setup page BASIC SYSTEM OPERATION 37 Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMED
7. and SmartSite are registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective owners U S Patent Nos 4 898 576 5 087 245 5 096 385 5 534 691 5 537 853 5 542 826 5 563 347 5 568 912 5 575 632 5 601 420 5 603 613 5 609 576 5 712 795 5 716 194 5 719 761 5 803 917 5 827 223 6 016 044 6 211 642 6 356 225 D367 527 D367 528 D371 194 CA Patented Brevet 78 376 78 377 78 378 1 219 497 1 279 800 2 029 267 2 199 156 2 199 157 2 199 160 2 199 405 2 199 631 2 233 640 EPO78635 CH 122 210 122 211 122 212 248 632 121 931 DE D B P Nos M9501995 2 M9501996 0 M9501997 9 P3482620 3 P3778211 8 08 P69004833 5 08 P690244 923 69402231T3 FR Brevet Nos 121 931 248 632 387 724 431 310 612 004 951 426 951 427 951 428 GB Patent Nos 121 931 248 632 387 724 431 310 612 004 2 045 812 2 045 813 2 045 814 Hong Kong Nos HK1006005 HK1006006 HK1006041 JP Patent Nos 5 4498 1 003 444 5 48351 003 445 5 Bek 381 000 528 5 Het 1 743 342 5 Ke TS 1 924 062 5 REP 2 553 557 4 RET 2 802 171 5 RET HH3 025 018 amp HAT 3 025 019 5 RE 3 064 014 4 SE Sv pat nr 387 724 Other Patents Pending 147859 103 Copyright 2003 ALARIS Medical Systems Inc All rights reserved 0086
8. disappears e Day is defined as continuous delivery for 24 hours per day 4 If concentration unit is appropriate press ENTER OR To scroll through units available press and release soft key When correct unit is displayed press ENTER e Weight or height unit selections are displayed only if appropriate for dose unit selected Concentration mcg mg gm Un or mEq 5 If weight or height unit is appropriate press ENTER OR To scroll through units available press and release VAN soft key When correct unit is displayed press ENTER Weight kg or Ib Height cm or inches 60 ADVANCED OPERATIONS Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued Programming DRC When a Drug Name is Not Listed Continued 6 To approve all displayed information and advance to first setup page press ok soft key e To calculate volumetric rate proceed to Calculating Volumetric Rate section e To calculate dose rate proceed to Calculating Dose Rate section Calculating Volumetric Rate 1 To enter dose rate use numeric keypad Press ENTER e Concentration is highlighted 2 To enter desired value use numeric keypad Press ENTER e Diluent volume is highlighted 3 To enter diluent volume use numeric keypad Press ENTER e f applicable patient weight and or height is highlighted ADVANCED OPER
9. 30 mmHg range without set installed to verify pressure calibration NOTE If the reading is out of range refer to the Pressure Calibration section of Service Bulletin 490 or 495 or most current version or contact ALARIS Medical Systems Technical Support for assistance Functional Test 1 Turn instrument on without set installed Verify it beeps and red alarm light flashes but does not stay lit Set Infusion rate to 460 mL h and VTBI to 100 mL Press 9 with latch closed and rate and VTBI 0 to cause Set Out and Air In Line messages Open latch OPTIONS 110 MAINTENANCE Check In and Configuration Continued Functional Test Continued Install primed administration set with latch open Verify instrument displays Air In Line and Latch Open messages Close latch and verify display returns to setup page Perform Upstream Occlusion Test as follows a b Verify infusion rate is set to 460 mL h With instrument on hold or at start up verify primary VTBI is set to greater than 100 mL Press to begin infusion Clamp off IV line just above instrument about two inches to simulate an upstream occlusion Verity instrument stops running alarms and displays OCCLUSION UPSTREAM within 60 seconds Press to silence alarm and put instrument on hold Release or open clamp and remove from tubing Press to resume infusion Alarm
10. Applicator 4 Close latch so tip of applicator is enclosed between Air in Line Detector and Ailr in Line Arm Latch Closed g 5 Swab up and down at least three times atch Closed Cotton Tipped Applicator 6 Open latch and remove applicator 114 MAINTENANCE Inspection Requirements To ensure the instrument remains in good operating condition GZ both regular and periodic inspections are required Failure to perform these inspections may result in improper instrument operation Instruments are tested and calibrated before they are packaged for shipment To ensure proper operation after shipment it is recommended that an incoming inspection be performed by your facility before putting the instrument into use Regular inspections consist of a visual inspection for damage Regular Inspections and cleanliness and performing the procedure described in the PROCEDURE FREQUENCY Start Up Sequence section of this document before each usage of the instrument Regular inspections are not covered Cleaning As required under any contract or agreement offered by ALARIS Medical Inspect for Damage Systems and must be performed by the user Case Each usage Communication Cable Each usage Power Cord Each usage Start Up Sequence Each usage Preventive maintenance inspections are recommended at the Preventive Maintenance Inspections indicated intervals PROCEDURE FREQUENCY The preventive maintenan
11. Multi Dose Multi Dose Alert Multi Step Panel Lock Options On Off 50 100 200 or 500 mcL On Off On Off Low Med Hi Med Hi Hi 300 600 1200 1800 2400 4800 9600 Monitor Off Off Even Odd None 0 Off 1 to 9 Resistance High Resistance Pressure On Off On Off Adjustable Fixed On Off 25 600 mmHg 25 600 mmHg 600 mmHg 0 100 On Off On Off 1 600 mmHg 9 digits 4 alpha numeric 0 1 20 0 mL h 1 52 wks On Off On Off On Off On Off On Off On Off On Off Default On 100 mcL Off On Low Med H 9600 Off None 3 Pressure On On Adjustable On 600 mmHg 600 mmHg 100 On On 600 mmHg 000000000 GOLD 5 0 ml h 52 wks On On On Off Off Off On 104 MAINTENANCE Feature Pressure Sensor Self Check Interval Profiles Rate Maximum Regional Settings VTBI Configurable Options Continued Options 1 52 wks Off 0 1 999 9 ml h Region N America European Language English On Off Flow Sensor use These features are configured in the Diagnostics Mode Default 12 weeks Off 999 9 ml h North America English On Instruments manufactured for sale in Europe will be set at the factory to European English If a new logic board is installed or the instrument is set to factory defaults the instrument defaults to North America English If the language needs to be reset contact qualified service person
12. e Return To Secondary appears ry app toe 3 2 Press yes soft key Zz NOTE Pressing no soft key returns screen to primary infusion page e Secondary infusion page appears 3 Verity all settings are correct If a change is required refer to Making Changes During Secondary Infusion section 4 To resume secondary infusion press a BASIC SYSTEM OPERATION 25 Changing Primary Solution Container 1 Place channel on hold 2 Remove empty solution container 3 Spike new container e Ensure drip chamber ts filled to 2 3 full 4 Press VTBI soft key 5 To enter a new VTBI use numeric keypad Press ENTER 6 To restart infusion press channel s Ly Unloading Set 1 Place channel on hold 2 Open latch e AccuSlide Flow Regulator automatically closes to prevent accidental free flow 3 Press latch fully to right e Set is ejected from instrument To prevent free flow verity the AccuSlide Flow Regulator is closed when the set is removed trom the instrument CAUTION Do not attempt to force the set from the instrument Send the instrument to qualified service personnel 26 BASIC SYSTEM OPERATION Unloading Set Continued 4 Whenever instrument is not in use close latch es 5 Turn off power as necessary Powering Off Press and hold channel s until display turns off
13. or Version 4 08 Europe are as follows e New Patient prompt during start up Unless all power is lost previous infusion parameters are retained in memory until the instrument is powered on and New Patient Yes is selected six hour memory rule no longer applies For programming information refer to Start Up section in Basic System Operation chapter e Flashing KVO rate during KVO alert When the instrument reaches KVO status the KVO LED indicator and the KVO rate flash For further information refer to KVO Mode section in Basic System Operation chapter e Maximum rate notification A prompt displays if the programmed infusion rate exceeds the configured maximum rate For further information refer to Alarms Alerts and Prompts section in Basic System Operation chapter e Pressure limit notification In the Adjustable Pressure Mode a prompt displays if the default pressure alarm setting exceeds the configured maximum pressure The default setting is the occlusion level at power up and can be adjusted down or up to the maximum level This feature is only configurable by qualified service personnel For further information refer to Alarms Alerts and Prompts section in Basic System Operation chapter e Combined drug list in Dose Rate Calculator Mode In the Dose Rate Calculator Mode the drug list is no longer divided between short and extended lists
14. 40 to 140 F 40 to 60 C 40 to 140 F 40 to 60 C 0 1 to 270 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 102 MAINTENANCE Specifications Continued Ground Current Leakage Electrical leakage current enclosure lt 100 microamperes Electrical leakage current patient lt 10 microamperes KVO Flow Range 0 1 to 20 0 ml h in 0 1 mL h increments o Mode of Operation Continuous Power Requirements 100 240 V 50 60 HZ 40 watts 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 the time with 95 confidence under the conditions listed below For rates equal to or less than 1 ml h 6 5 95 of the time with 95 confidence under the conditions listed below Rate Accuracy Test Conditions Infusion rate range 0 1 to 999 9 mL h Head height 24 1 in 61 2 5 cm Test solution distilled water Environment temperature 68 8 F 20 4 C Back pressure O psi Needle 18 gauge Set Model 72003 Minimum collection volume 6 mL CAUTION Variations of head height back pressure time monitoring mode option pump tilt or any combination of these may affect rate accuracy Factors that can influence head height and back pressure are IV set configuration IV solution viscosity and IV solution temperature Back pressure may also
15. 544 Sin gle Use Single Use Do not re use Product contains a particular element such as DEHP in fluid pathway Product DOES NOT contain a particular element such as set Is latex free Drops per milliliter soecification for product will be identitied on drop symbol Product incorporates SmartSite Needle Free Valve Ports and should not be accessed by a needle Kh ee O x XX mI Approximate set priming volume Expiration date for product will be identified near hour glass symbol Do not use if package is damaged wd INTRODUCTION 9 cm day gm HLD kg KVO mcg mcL mEq mg min mL mUn nan OPT PRI rev SEC Un VI VTBI wks Symbols and Terms Continued centimeter day d gram 9 hour infusion in hold mode inch kilogram keep vein open infusion rate mode pound microgram ug microliter uL milliequivalent milligram minute milliliter milliunit nanogram ng options mode orimary infusion mode revolution r secondary infusion mode unit volume intused volume to be infused weeks 10 INTRODUCTION BASIC SYSTEM OPERATION NOTE Although the Signature Edition Pump is built and tested to R Only exacting specifications it is not intended to replace the supervision of IV infusions by medical personnel The user should become thoroughly familiar with the features and operation of the syst
16. 8 5 gt BASIC SYSTEM OPERATION mA WARNINGS AND CAUTIONS o lt cscsuactes nnremvaceeenen EEEE EEEE EEEE yenbact een tteeeees 11 2 lt PRERARINGAN WME SION Jac soremcateaenh os ekegascdas oy caea sions Saaana E E p Enae MEE PENARE s EA endah ies 16 O Preparing Primary Solution COMAING sesssisrarssersisvrssrrtiaaa pee etbece sds swewere boson peebaNGe seers as 16 z Preparing Primary Administration Set 00 0 0 16 Loading Primary Administration Slain cascseua ses onsterdekseGecageriiueohsuebesdaestesacsednintasenes 43 17 ARTO E E A E E E E E E E eee dead 18 PRIVAR INFI SON 2 grsrerg iita arrr Ea ar E arIa EEN ESG e 19 Q gt Making Changes During Primary Infusion 0 0 bbe eee 20 m Resuming an Interrupted Primary Infusion n oaaae aaaea aeaaea 21 P YO MODE esr Cob sense a adage E R eee E ee de deque sent poacuta noes bauyaeneseer esas 21 O Q Resuming Primary Operation from KVO oeaan aaaea aaeeea 21 J IECONDART INFUSION gece cup ce retenue r EE was eR eN a ENEE ee EATE E R EEA 22 Making Changes During Secondary Infusion 22 0 24 Viewing or Changing Primary Settings During Secondary Infusion 0 0 0 00 0 24 Resuming an Interrupted Secondary Infusion 200 25 gt CHANGING PRIMARY SOLUTION CONTAINER 020000000000 aaea 26 an AG UNLOADING SET iE b EEEE 26 Peas PO EIN GOP ances AE AEEA EE pee enced EERE cease at fue REE pi EEEE E pp T OE RESE EEEE e eat 27 O AIR IN LINE AND ACCUMULATED AIR IN LINE onanan cece nen ne ene beeen 27 AA
17. S m Z U GADNVACV Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued 4 Press soft key corresponding to first letter of desired drug OPTIONS e A list of drug names is displayed 5 To view additional drug name selections press page soft key e f desired drug name is listed proceed to Programming DRC When a Drug Name is Listed section e f desired drug name is not listed proceed to Programming DRC When a Drug Name is Not Listed section Programming DRC When a Drug Name is Listed 1 Press soft key next to a drug name to select it e Appropriate dose units for selected drug are displayed Dose units cannot be changed 2 To approve all displayed information and advance to first setup page see Calculate Volumetric Rate press ok soft key OR next step 3 To change concentration height or weight units press soft key next to a unit to select it e Weight or height unit selections are displayed only if appropriate for drug selected VAN soft key appears 58 ADVANCED OPERATIONS Entering a New Program Continued Programming DRC When a Drug Name is Listed Continued Drug Specific Dose Rate Calculator DRC Continued 4 Toscroll through units available press and release VN soft key When correct unit is displayed press ENTER Concent
18. System Continued Resistance Trend Graphs Continued Viewing Resistance Mode Trend Graphs Continued 2 Press Resistance Trend soft key e Atrend graph appears 3 To change graph time frame press time soft key e A dashed horizontal line represents current optional resistance alert level e Gaps in graph may indicate noninfusing conditions such as turned off on hold in alarm etc e f 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 SNOILVYs4dO GADNVACV e A tick mark J at top of graph indicates an occlusion NOTE When viewing Resistance Trend Graphs in the High Resistance mode HI RESIST displays under the graph Clearing Resistance Trend Graphs 1 To clear graphed data press clear soft key 2 Press ok soft key ADVANCED OPERATIONS 4 7 Dynamic Monitoring System Continued Resistance Trend Graphs Continued Clearing Resistance Trend Graphs Continued e All data is cleared from graphs Returning to Normal Operating Screen Press return soft key e Normal operating screen appears NOTE Any of the following events will also turn off the trend graph e Pressing dual channel instrument only e Pressing R95 l e An alarm Dual channel instrument Trend Graphs will disapp
19. after one minute and be replaced with a split screen display if both channels are infusing ADVANCED OPERATIONS 55 Dynamic Monitoring System Continued Detection of Upstream Occlusions If the flow pathway between the fluid container and the AccuSlide Flow Regulator is obstructed due to kinked tubing a closed clamp or an improperly installed set then an OCCLUSION UPSTREAM condition exists Depending on where the upstream path is occluded flow may continue for a fraction of a mL before the OCCLUSION UPSTREAM alarm is produced At high infusion rates the instrument will take relatively little time to alarm At low infusion rates a longer time will elapse before the instrument detects the condition and alarms In either case some flow continues from the instrument during the time prior to the alarm due to the elastic behavior of the tubing between the occlusion site and the pumping mechanism If an OCCLUSION UPSTREAM alarm does occur investigate and remedy the cause Ensure that the upstream flow path tubing etc is free of obstructions that any clamp is open and that the blue flow control on the AccuSlide Flow Regulator is in the open up position before resuming the infusion When the instrument detects an upstream occlusion condition it will present the message OCCLUSION UPSTREAM sound the audio alarm and stop infusion In certain conditions the upstream alarm system may briefly pause the instr
20. but is combined into one list For programming information refer to Drug Specific Dose Rate Calculator DRC Entering a New Program section in Advanced Operations chapter 2 INTRODUCTION Controls and Indicators Model 7130 7131 POWER Key Turns instrument on and off Power Indicator Green Plugged in and charging Flashing Amber Battery power Z JJ J C N z Z Infusing Indicator Indicates instrument is infusing Alarm Indicator Indicates instrument is in alarm and has stopped infusing RUNeHOLD Key Starts and stops infusion OPTIONS Key Accesses additional features Secondary SEC Key Selects secondary mode Primary PRI Key Selects primary mode Soft Keys Refer to Main LCD Display in Displays section of this chapter Enter Key Accepts value or selection entered Silence Key Silences audible alarm or alert for two minutes message remains on screen New alarm or alert will reinstate audible tone Clear Key Clears selected numeric value Audio Volume Key Sets audio volume for alarms alerts and KVO tone Press key to adjust volume Numeric Keypad Enters changes values INTRODUCTION 3 Controls and Indicators Continued Model 7230 7231 Channel Select Keys Indicators Select channel A or B Light to indicate which channel is selected Alarm Indi
21. either Rate and Volume or Volume and Time At completion of the last programmed step the channel will switch to the preset KVO rate or remain at the current rate whichever is less Qualified service personnel can turn the Multi Step feature on or off ADVANCED OPERATIONS 71 SANLO AATA E s L0 GADNVACV Multi Step Program Continued Entering a New Program Select the desired channel as necessary The channel must be on hold in the primary mode secondary mode or a Loading Dose program 1 Press oPtions e Options page appears 2 Press page soft key e Second options page appears 3 Press Multi Step soft key e MULTI STEP MENU appears 4 Press Enter New Program soft key e PROGRAMMING OPTIONS page appears 5 To select setup method press a soft key e f Rate andVolume is selected instrument calculates step infusion time Proceed to Programming by Rate and Volume section e If Volume and Time is selected instrument calculates rate Proceed to Programming by Volume and Time section Programming by Rate and Volume 1 Press Rate and Volume soft key e STEP 1 of infusion profile is displayed e Rate is highlighted 72 ADVANCED OPERATIONS Multi Step Program Continued Entering a New Program Continued Programming by Rate and Volume Continued 2 To enter rate use numeric keypad Press ENTER e V
22. fluid is flowing e A gravity flow rate may be adjusted with AccuSlide Flow Regulator thumb clamp if desired 16 BASIC SYSTEM OPERATION Preparing an Infusion Continued Loading Primary Administration Set 1 Slide AccuSlide Flow Regulator thumb clamp down until an audible click verifies it is in Tully closed position sihnumb Clamp 4 2 Using both hands press top and bottom of AccuSlide Flow Regulator into instrument until it snaps into place gt GH a SU alr Si lt a Verity three gray fingers clamp arms on each side of pumping mechanism have engaged AccuSlide Flow Regulator b Let go of set A properly loaded set should stay In instrument 3 Press firmly just below blue thumb clamp on AccuSlide Flow Regulator with one hand while using other hand to close latch fully to left e f resistance is met while closing latch remove set verify AccuSlide Flow Regulator is fully closed and then reinstall set e Verify thumb clamp has moved to open up position prior to starting infusion After set installation verify no fluid is flowing through the administration set s drip chamber to avoid free flow 4 Attach set to patient s vascular access device 5 Verity tlow trom IV container after starting infusion BASIC SYSTEM OPERATION 17 Start Up 1 To turn channel on press Power e Instrument per
23. less than one third of the alarm limit within 40 seconds normal flow resumes The Adjustable Pressure mode allows the operator to control the pressure alarm limit If the condition is not cleared the OCCLUSION DOWNSTREAM alarm occurs and infusion is stopped until manually restarted Qualified service personnel can turn off this feature or program from one to nine Checking Line restarts After the programmed number of restarts has occurred or the 40 second Checking Line period has been exceeded the channel will immediately alarm OCCLUSION DOWNSTREAM when pressure conditions indicate an occlusion The programmed number of restarts become available again when or the soft key labeled run is pressed ADVANCED OPERATIONS 49 Dynamic Monitoring System 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 Qualified service personnel can turn the adjustment feature on or off set a default alarm level and set a maximum pressure limit Setting Alarm Limit Marker To numerically display present alarm limit press either or P soft key e Each additional press of either arrow soft key changes alarm limit by 25 mmHg in corresponding direction NOTE It is advisable to select an alarm limit appropriate for the flow rate At lower flow rates the alarm limit should be set
24. min NOTE The plot range has been increased to 100 to allow visualization of the graph 30 30 mL h Resistance Mode Start up at 1 mL h initial 2 0 1 8 1 6 1 4 pi M 1 Hi il i i z AOA HAI aa ne AMT tH 0 0 0 2 0 20 40 60 80 100 120 Time min Resistance Mode Trumpet Curve at 1 mL h initial o oO oO Flow Rate Error oO 5 10 15 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 1 mL h 48 hr 15 10 Flow Rate Error or ro o h h oO 0 5 10 15 20 25 30 Observation Interval min Legend M Maximum rate error m Overall rate error Minimum rate error 122 APPENDIX Trumpet and Start Up Curves Continued Resistance Mode Continued Resistance Mode Start up at 25 mL h initial ANAM AN Mall ll MAAN Al Malih 1 iV WV eo ee T Hy ny VT aT VIU HUY mL h 0 20 40 60 80 100 120 Time min Resistance Mode Trumpet Curve at 25 mL h initial Flow Rate Error 0 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 25 mL h 48 hr EN i O S o i S Flow Rate Error aa 15 0 5 10 15 20 25 30 Observation Interval min 2 1 1 1 1 1 mL h Flow Rate Error Flow Rate Error 000 800 600 400 200 000 800 600 400 200 200 Resistance Mode Start up at 999 9 mL h i
25. pressing and then ENTER Loading Dose Infusion OR Primary VTBI can be deleted from the primary mode setup page S Configurable Options SP 4 To enter a new value use numeric keypad 5 To accept new value s press ENTER Clearing Total Volume Infused During Loading Dose Infusion 1 To highlight value press Total VI soft key 2 To reset volume infused to 0 0 mL press or 0 zero key 3 To accept new value s press ENTER e Display returns to normal LOADING DOSE page after six seconds 90 ADVANCED OPERATIONS Loading Dose Continued Resuming an Interrupted Loading Dose Program 1 Follow Start Up Sequence steps and select NEW PATIENT no NOTE If resuming an infusion on a dual channel instrument with an infusion currently running NEW PATIENT screen does not appear e Return To Loading Dose page appears 2 Press yes soft key e Pressing no soft key returns screen to primary set up page 3 Verify all settings are correct If a change is required refer to Making Changes During Loading Dose Program section 4 To resume infusion press a v m S m Z U GADNVACV ADVANCED OPERATIONS 91 THIS PAGE INTENTIONALLY LEFT BLANK 92 ADVANCED OPERATIONS ADDITIONAL FEATURES NOTE All features and options are shown enabled in this section The optional featur
26. require consideration of such variables as factory overfill medication additions etc Underestimating the volume will cause the remaining secondary solution to be intused at the primary rate overestimating will result in the primary solution being intused at the secondary rate Multiple doses from a single container are not possible When the device 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 line is level with the fluid in the primary container NOTES e Prepare the secondary container and set Lower the primary container using the hanger included with the secondary set Ifa flow sensor is being used it must be placed on the primary line e The maximum rate for a secondary infusion is 270 mL h The c e The flow sensor is not used for the first 25 mL delivered when A E doa changing from secondary to primary This is to account for must be opened If the clamp is overfill of secondary containers not opened the fluid will be delivered from the primary container e The secondary set must be primed prior to beginning the secondary infusion 22 BASIC SYSTEM OPERATION Secondary Infusion Continued Follow Start Up steps e Primary setup page appears NOTE If programming a secondary from a running primary
27. set will produce a smaller variability In order to ensure overall accuracy is achieved new instruments are tested to an accuracy of 3 with the Model 80VCS set during New Instrument Check In Due to the Dynamic Monitoring Feature the rate is varied during operation For this reason ALARIS Medical Systems does not recommend using automatic testers to check rate accuracy Generally these devices collect small samples and may cause the results to be incorrect even though the instrument is accurate Do not use the Model 80VCS Calibration Set for more than 30 rate verification runs 15 rate calibration number changes Keep track of the number of times the set is used by recording each use on the 80VCS insert or on a separate record Rate Accuracy Qualification Test Setup Water Source Burette 50 ml 30 1 in 76 2 2 5 cm Burette Clamp Equipment Stand lt gt 2 mi Z gt Z A mi Table or Bench Three Way Inst t Stand iei nstrument Stan Used Fluid Receptacle MAINTENANCE 107 Check In and Configuration Continued Rate Accuracy Qualification Test Continued 1 Fill solution container with clean tap water Close AccuSlide Flow Regulator clamp on 80VCS Calibration Set and the
28. should not reoccur Perform Downstream Occlusion Test as follows Continue infusing from step 8h Verify rate is set to 460 mL h Clamp off IV line just below instrument about two inches to simulate a downstream occlusion Allow instrument to run until it alarms OCCLUSION DOWNSTREAM Verify this occurs within 60 seconds Press to silence alarm and put instrument on hold Release or open clamp and remove from tubing Press to resume infusion Alarm should not reoccur Press to stop infusion MAINTENANCE 111 lt gt 2 m Z gt Z A m Check In and Configuration Continued Flow Stop Test 1 With an administration set primed and loaded in instrument turn off power 2 With all tubing clamps open and fluid container two or more feet about instrument verify no fluid flows through set 3 Open latch and remove set Verify no fluid flows through set Ground Current Leakage Test Use a DNI Nevada Model 232D or equivalent to measure the ground leakage current Refer to the test equipment s operation manual for the proper setup and measurement technique Leakage current must be lt 100uA for normal and reversed line polarity Ground Resistance Test Use a DNI Nevada Model 232D or equivalent to measure the CAUTION ground resistance Measure resistance from the AC power plug ground pin to the screw for the power cord strap or to the screw for the battery cover on the chassis Re
29. time for two hours from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data FLOW CHARACTERISTICS UNDER VARYING DELIVERY CONDITIONS Effects of Pressure Variations Under conditions of 100 mmHg pressure the Signature Edition Pump typically exhibits a long term accuracy offset of approximately 1 4 from mean values Under conditions of 300 mmHg pressure the Signature Edition Pump typically exhibits a long term accuracy offset of approximately 1 5 from mean values Under conditions of 100 mmHg pressure the Signature Edition Pump typically exhibits a long term accuracy offset of approximately 0 8 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under these pressure conditions Effects of Negative Solution Container Heights With a negative head height of 0 5 meters the Signature Edition Pump typically exhibits a long term accuracy offset of approximately 5 8 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under negative head height conditions Effects of Rate For applications where flow uniformity is a concern use of the Pressure M
30. time may be affected by the operating mode rate monitoring options and back pressure e The gauge accuracy is based on the last refresh cycle and is affected by the number of charge discharge recharge cycles The instrument label and battery gauge are always displayed even when the instrument Is turned off however the battery gauge does not represent the battery time remaining when the instrument Is turned off ADDITIONAL FEATURES 93 Battery Management System Continued Battery Recharge The battery recharges whenever the instrument Is plugged into an AC outlet Qualified service personnel can replace the battery when charging capacity gets too low s Ky Cell NOTE All batteries gradually lose their capacity to hold a charge over time and use To maintain optimal battery performance ensure the instrument is connected to AC power whenever possible including when it is powered off or stored Nurse Call 7130 7230 Only If the instrument is equipped with the optional nurse call feature alarms and some alerts from the instrument will be relayed to the hospital s existing nurse call system No operating features of the instrument are changed The instrument will alarm with or without the nurse call installed
31. to secondary mode or press no soft key to return to primary setup page Channel will automatically switch to primary infusion settings Channel must be on hold to change modes Press or and then continue with editing Load the AccuSlide Flow Regulator segment in selected channel Repeat manual pressure baseline setting Reinstall the AccuSlide Flow Regulator segment 38 BASIC SYSTEM OPERATION Alarms Alerts and Prompts Continued WTS SyANG PROBABLE CAUSE REMEDY SET OUT Set has been removed during an Reinstall set Press run soft key Q Alarm infusion Set Pressure Baseline Set Pressure Baseline has been Press ok soft key to set Pressure Prompt selected in options mode Baseline or press return soft key to go to Primary Setup page Set Pri VTBI A primary VTBI was not Enter a primary VTBI A 2 Prompt programmed D L JJ D 7a Set Pri VTBI gt Loading Dose Loading Dose VTBI entered is Raise primary VTBI or lower a a VTBI greater than primary VTBI Loading Dose VTBI as a z Prompt appropriate SETUP TIME EXCEEDED Instrument has been turned on Press hold soft key to return to B Alarm but no keys have been pressed hold mode for ten minutes Instrument will turn off if left in alarm more than five minutes If an audio alarm remains on turn instrument on and then off Stop Timer to Change An invalid key was pressed while Wait several seconds for popup Prompt timer was running in Multi Dose to fi
32. to be edited Changing Primary Infusion Rate e Current value is highlighted NOTE Ifthe flow sensor option is in use VTBI can be turned OFF by selecting VTBI pressing and then ENTER OR The primary VTBI can be deleted from the primary mode setup page Configurable Options 2 To enter a new value use numeric keypad 3 To accept new value press ENTER Clearing Volume Infused 1 Press VI soft key e Current value is highlighted 2 To reset volume infused to 0 0 mL press or 0 key 3 To accept new value press ENTER 20 BASIC SYSTEM OPERATION Primary Infusion Continued Resuming an Interrupted Primary Infusion 1 Follow Start Up steps and select NEW PATIENT no NOTE If resuming an infusion on a dual channel instrument with an infusion currently running NEW PATIENT screen does not appear e Primary infusion page appears 2 Verify all settings are correct If a change is required refer to Making Changes During Primary Infusion section 3 To resume primary infusion press oek gt a a EY alr SE lt KVO Mode The KVO keep vein open mode automatically occurs when the primary VTBI has counted down to 0 0 mL The channel switches E HF to the preset KVO rate or remains at the current rate whichever SS at KVO OPT HLD PRI SEC is less e KVO rate Is flashing in rate LED display Main LCD Dis
33. 08 MAINTENANCE 16 17 18 T9 20 ZN 22 23 24 ZS 20 Check In and Configuration Continued Rate Accuracy Qualification Test Continued Adjust fluid level in burette until meniscus is level with zero mark on burette l NOTE The instrument may need to be run to prime the line to the zero level of the burette step 13 Verify primary infusion rate is 400 mL h Reset VTBI to 40 mL and clear volume infused Press to start primary infusion Instrument will run approximately 360 seconds six minutes to complete delivery and then go into KVO mode Stop instrument within one second of its entering KVO mode Make a note of volume collected in burette Note expected volume as identified on 80VCS calibration set insert Do not remove 80VCS set from instrument until one of following is determined e Instrument has passed rate verification and calibration is not needed e Rate calibration number was changed and instrument now passes verification e Mechanism replacement is required Calculate volume accuracy as follows Volumetric Volume Accuracy Error Computation Vcollected volume in burette in milliliters Vexpected characterized volume printed on 80VCS set insert Step 1 A Vcollected Vexpected Step 2 B Ax 100 Step 3 Error round Error to nearest tenth of a percent B 100 Result should be 0 0 3 If volume accuracy does not fall within required range of 3 from expec
34. 2 84umanneees cannes hieeaese di bane POWEl Gauge chaos erinin aoe EEI evn eaten Pecan aru ses ods ated bd eo ane eee Battery Recharge 2 nee ete EEE EEEE EEEE NURSE CALL 7130 7230 ONY ccaecsertcce enn goles EEA OEREN va PRTA Se ERREEN Activating Nurse Call Feature cc nsen ther ot chunauicnad Gea anaes abn EEEE EEEE EEEE EEEE ke banangaea neues eA OCCU eede e E E E ER E EE ES EEY PINE HOCK oera E e ERE E a EE a E a E EEE E E canes Turning Panel Lock Feature ON 200 0 Turning Panel Lock Feature Off nace cary eras saeiewewes ostndl dues acackeedaienes dqneweeeee onan EERE TEDRE esas FO Rg perce ee eee EE tone badoratnsbad oe aues caupne E eeeerteeen eek sae easen ese Changing Pole Clamp Orientation 20 0000 POW DEIN SO Ren ss coeac ca uecaeeaos neue i puenrseesvous onuh neues wanes dsuean rar nanas cacy Gis aaee aegneencenaseee RS 232 COMPUTER LINK cues co ncdinde wee eiiudheeetns ependibbbens endudbnee ewe eg yabSibweeuesedeakbene seu des CONNEC toa CONU cs 22 cere aces o244050otseeaqcieennese coaqclnesenesahnatee meee es aeseaiatectees DISCONNECTING trom a COMPUTED secisiisprencsipa idr rter EET E dd RENE iI PEE TNE AREETAN MAINTENANCE SPEEA NON F nce eee ee cen oe ee ee ee ere AE oe eee oe es EEA en eee eE de eee anes CONFIGURABLE OPTIONS scuioccecedanecsaacancavueiebevenconsaasdueebeadmedanued gidanaeadane oe tacasweeaeas UNPACKING s oo een eet encase tian EEE A bcuseae aes eae ad denen AAEE AREE e EAA CHECK IN AND CONFIGURATION oo
35. ADNVACV Dynamic Monitoring System Continued Pressure Trend Graphs Continued Viewing Pressure Mode Trend Graphs NOTE For dual channel instruments select the desired channel as necessary The trend graph is not available while the split screen is displayed 1 Press otions e Options page appears 2 Press Pressure Trend soft key e A trend graph appears 3 To change graph time frame press time soft key e A solid horizontal line represents current pressure alarm limit level e Gaps in graph may indicate noninfusing conditions such as turned off on hold in alarm etc e f channel has been placed in a Resistance Monitoring mode for some portion of a trend graph window pressure data Is not available and zero values are plotted 54 ADVANCED OPERATIONS Dynamic Monitoring System Continued Pressure Trend Graphs Continued Clearing Pressure Trend Graphs 1 To clear graphed data press clear soft key 2 Press ok soft key e All data is cleared from graphs SNOILVYsdO GADNVACV Returning to Normal Operating Screen Press return soft key e Normal operating screen appears NOTE Any of the following events will also turn off the trend graph e Pressing dual channel instrument only e Pressing R95 e An alarm e Dualchannel instrument Trend Graphs will disappear
36. AL a EY alr Si lt Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY LATCH OPEN Q Alarm LATCH OPEN Prompt Load Dose Complete Alert Load Dose Running Prompt Maintenance Reminder Prompt Max Rate XXX X mL h Prompt NOTE XXX X represents the maximum flow rate configured for the instrument Multi Dose Running Prompt Multi Step Complete Alert Multi Step Running Prompt Latch was opened during an infusion Latch is open prior to starting an infusion Loading Dose program has just been completed or was pressed while running in Loading Dose program Periodic maintenance interval has elapsed User has attempted to enter a rate greater than maximum configured rate or instrument has calculated a rate greater than maximum configured rate Maintenance Reminder feature is on Default maximum rate is 999 99 mL h NOTE In the secondary mode the maximum flow rate will be 270 mL h or the maximum configured rate whichever is less or was pressed while running in Multi Dose program Multi Step program has just been completed or was pressed while running in Multi Step program Check for proper set installation Close latch Press run soft key Close latch fully to left Channel will automatically switch to primary infusion Channel must be on hold to change modes Notify Biomedical Engineering department If desired press conti
37. ARIS Medical Systems 72 Series administration sets Alarms Accumulated Air In Line Key Stuck Air In Line Latch Open Battery Depleted No Upstream Flow Detected Channel Malfunction Occlusion Downstream Computer Link Failure Occlusion Upstream Flow Sensor Unplugged Primary Flow Detected During Secondary Hold Time Exceeded Set Out Instrument Malfunction Set Up Time Exceeded Battery Rechargeable nickel cadmium A single channel instrument will operate for 4 hours nominal and a dual channel instrument will operate for 3 hours nominal under the following conditions e new fully charged battery e ambient room temperature 73 7 F 23 4 C e resistance monitoring modes e rate 100 mL h on a single channel instrument and 50 mL h on each channel of a dual channel instrument Battery run time is affected by operating mode rate monitoring options and back pressure See Battery Management System section of this document Case Impact and flame resistant plastic Critical Volume Maximum incremental volume in case of single point failure will not exceed 1 0 mL at 999 9 mL h Dimensions Nominal 7130 7131 7230 7231 Depth 5 0 in 12 7 cm 5 0 in 12 7 cm Height 8 6 in 21 8 cm 8 6 in 21 8 cm Power Cord 10 ft 3 m 10 ft 3 m Weight 6 6 b 3 0 kg 8 4 b 3 8 kg Width 7 6 1n 19 3 cm 10 7 in 26 7 cm Without pole clamp Without power cord lt gt 2 Z gt Z A MAINTENANCE 101 Downstream Occlusion Time
38. ATIONS 61 SNOILVYs4dO GADNVACV Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued Calculating Volumetric Rate Continued 4 To enter weight and or height use numeric keypad Press co e Instrument automatically calculates and displays volumetric infusion rate in mL h NOTE TTTTT or WN appears if a calculated value is outside the display s range e Use soft key to highlight value to be edited e Use numeric keypad to enter value e Press to accept change 5 Verity all values and units To approve all calculated and displayed information press ok soft key NOTE If the channel is running in the primary mode while setting up the calculation proceed to the last step in this section e Next setup page appears e VTBI is highlighted 6 To enter VTBI use numeric keypad Press ENTER NOTE If the flow sensor option is being used Dose Rate VTBI can be turned off by selecting VTBI then pressing CHAR OR Dose Rate VTBI can be deleted from VTBI VI screen and main hold page Configurable Options e VI is highlighted 62 ADVANCED OPERATIONS Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued Calculating Volumetric Rate Continued 7 To clear VI press or O zero key Press ENTR 8 To approve all displayed information and advance to main hold pag
39. Activating Nurse Call Feature RS 232 1 Plug nurse call cable into on instrument back panel NOTE A false remote alarm may occur if the nurse call plug is not properly inserted 2 Press channel s Power e Instrument beeps briefly to signal proper operation 3 Plug nurse call cable into nurse call system 4 Operate instrument as described in this document NOTE All alarms and some alerts activate the nurse call system The following alerts will not activate the nurse call system Checking Line Load Dose Complete Secondary Complete If an Alarm Occurs 1 Go to instrument 2 Use Alarms Alerts and Prompts section of this document to determine cause and appropriate corrective action 94 ADDITIONAL FEATURES Nurse Call 7130 7230 Only Continued If an Alarm Occurs Continued 3 Reset nurse call system as required NOTE Disconnecting the nurse call cable from the wall or turning off the instrument activates the nurse call system Disconnecting the nurse call cable from the instrument will not activate the nurse call system Panel Lock The panel lock feature helps prevent unauthorized changes of any instrument settings including turning the instrument off The panel lock key is located behind the handle Turning Panel Lock Feature On Press and hold until appears in lower display e Dual channel instrument only A and keys can be used to view s
40. E EEEE EEEE EEE EEEE Making Changes During DRC Program 6 esiccusicvnss co ewererneecancewe bhedsrdenneees bas atwaweeeeedeenes Resuming an Interrupted DRC Program 2 ene EEEE EEEa Quitting DRG Progra 130s s ccnyehonseuntadhnea E E EEEE dahebsuen arbagngohinien ie sddgddbene EE E as MULI TEP PROGRAM persenan ob aA Gon becapenn ees ETAN a EE EAEE NEN oat ERICHING a New Trogirani ccscencanepaccesstanciecasscsenaian EEA RAER Making Changes During Multi Step Program 20 Resuming an Interrupted Multi Step Program 0 0 0 0 cence bet ences Quitting Muni step Progra ereer etree wad REEERE ss seeped EETA TEE E ANTEE E MOLEDOSE PROGRAM ccxtcasondansracand vs cumeeweoaars a EE EEDE i a nE EES eds Entering a New Progra sessiessrrehoseidet ert sAnne EPEE r PETREL EAA A LAE A Mi nsasiees de EREN Making Changes During Multi Dose Program oonaaaaaa naana aaaeeeaa EEEE EEEE EEEE EEEa Resuming an Interrupted Multi Dose Program 20 Q it ng Muli Dose PONa 3 xeg ewes pooe were aeons odbade artes oacgen eae nee acdsee Tera mop ge ueseeesa cs LOAD INGHD E P E EEE PE E T TEE EEE E EE EEEE E E ENEE TTE Entering a New Program 2 0 nn E EEEE EEEE Making Changes During Loading Dose Program 20 6 EEEE EEEE EEEa Viewing or Changing Primary Settings During Loading Dose Infusion 0 0 00 00 20 0 c cece ee Resuming an Interrupted Loading Dose Program 0 6 cette neces ADDITIONAL FEATURES DA Wen MANAGEMENT Si SPW sertene rreren Re e a 4
41. Observation Interval min Legend E Maximum rate error m Overall rate error Minimum rate error 120 APPENDIX Trumpet and Start Up Curves Continued Pressure Mode Continued Pressure Mode Start up at 25 mL h initial Pressure Mode Start up at 999 9 mL h initial 5 2000 45 1800 40 1600 35 1400 30 1200 25 1000 E 20 Z 800 15 600 10 400 5 200 0 0 5 200 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Time min Time min Pressure Mode Trumpet Curve at 25 mL h initial Pressure Mode Trumpet Curve at 999 9 mL h initial 15 10 55 5 it it gt c 10 15 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min Pressure Mode Trumpet Curve at 25 mL h 48 hr Pressure Mode Trumpet Curve at 999 9 mL h 24 hr 15 10 o o uw in g 0 2 aa LL LL 10 15 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min Legend E Maximum rate error Overall rate error Minimum rate error gt z a a Z z x APPENDIX 121 Trumpet and Start Up Curves Continued Resistance Mode mL h 100 O O O 20 Resistance Mode Start up at 0 1 mL h initial Time min Resistance Mode Trumpet Curve at 0 1 mL h initial 5 10 15 20 25 Observation Interval min Resistance Mode Trumpet Curve at 0 1 mL h 48 hr 5 10 15 20 25 Observation Interval
42. Signature Edition GOLD INFUSION PUMP Models 7130 7131 and 7230 7231 Guardrails Safety Software Compatible DIRECTIONS FOR USE NOTE to Guardrails Safety Software Users This instrument is compatible with the Guardrails Safety Software for Signature Edition GOLD Infusion Pumps If the Profiles Feature is not enabled Off this Directions for Use applies If the Profiles Feature is enabled On with the Guardrails Software the user interfaces may be different For further information refer to the Directions for Use for the Signature Edition GOLD Infusion Pump with the Guardrails Software installed TABLE OF CONTENTS INTRODUCTION _ ABOUT TRE INSIROMENT c2secsecuaceeesescse run ceencasedeuoiininaes eunageedGuneaneaiiminesnseehsaeuneaeuecs 1 NEW USER INTERFACE FEATURES onnaa 2 O CONTROLS AND INDICATORS ooa EEEE EEEE EEEE EEEE EEEE 3 PLAS e E A E E A E E as ae eeeeaeae a 5 a Main LCD Display a s scccnoag ot aeaessaniesl aopacenesehd ages Jimena 2s ERA a EENE ETARA NPERARE TERRE 5 O Rate DIDAS suo csynuutesws cbeweiaesss aRar r aa a E E REED 6 Z LONG DIST IOY rer earen EEEE EES eee E ER A E Gene AREA E EE AREE EEE E EAEE RT 6 AROUND THE INSTRUMENTS sc co ecunseaoscosgscuonebcecsetubhadscupate nese hi doestacpbaesasetesaaysedes sas 7 SYMBOLS AND TERM S seerste rne eeann EEE R ued EAN aa peo ER rE Ben geaternsedease
43. Single or Accumulated Air Bubble Detection NO Reset Feature 20 00 0000 00 28 T Single or Accumulated Air Bubble Detection Reset Feature Available 0 0 00 00 00 0 00 ee 28 ALARMS ALERTS AND PROMPTS s cc0ccut004 conauwies phe cnesdeesydsacaesetus ohacdiweetieyhs case netersenea i 29 ADVANCED OPERATIONS DYNAMIC MONITORING SYSTEM sg lt d00 idea cechvuxdaoaduva peau aa erar rerai aa iera i Eanna as AA 41 Z Monitoring Options General c 2c2nreveevcnsaeadscanuntdaeadereaducnabhiascudethadvedeedatshareeaeser en 41 Monitoring Options Resistance Mode 0 aana aaaeeeaa 44 Resistance Alert 1 5 2446ceensecchaniaonehanasadeseansha ahaide aeann aaea haikai neadan abeta oat 45 a Resistance Trend Cie 0 2S ee ene ane et eC mn ve E a p Eiaa ai 46 m Monitoring Options Pressure Mode 2 0 EEEE EEEE EEEE EEEE EEEa 48 Adjustable Pressure Alarm 2 no25 45imitcdo aana pp dae al ed vo eee ei odd ape hws Aide a 50 Pressure BASHING 2o44cccsncnacsaahicagashedadearnusruchaaeisanbns dead pmasnahnctadannssacweeadaad ai haea de 51 Pressure rend Graphs ana te eduquaneetnas ieaerastata ere aS nRa oun ERa D p i ned 53 Detection of Upstream OcCcIUSIONS 9200 56 gt z a Y Z z x TABLE OF CONTENTS ADVANCED OPERATIONS Continued DRUG SPECIFIC DOSE RATE CALCULATOR DRG scsodsstonatentaas sano earenatesaedienendestiosecaseesies Facts About DRC 200 EEEE EEEE EEEE EEEE EEEE EE EEEE EEEE EEEE Entering a New Program 2 0 nn EEE
44. TBI is highlighted 3 To enter VTBI use numeric keypad Press ENTER e Instrument automatically calculates and displays time in hours and minutes 4 To approve all displayed information and advance to STEP 2 of infusion profile press ok soft key 5 To set up each additional step of infusion profile repeat steps 2 through 4 6 When all steps have been entered and ok d press done soft key e Review page s display three profile steps at a time 7 To approve and advance through review page s press ok soft key 8 To clear VI if desired press or 0 zero key Press ENTER ADVANCED OPERATIONS 73 SNOILVYsdO GADNVACV Multi Step Program Continued Entering a New Program Continued Programming by Rate and Volume Continued 9 To approve STEP TOTALS page press ok soft key e Main hold page is displayed 10 To start Multi Step infusion program press 9N Or run soft key Programming by Volume and Time 1 Press Volume and Time soft key e STEP 1 of infusion profile is displayed e VTBI is highlighted 2 Toenter VTBI use numeric keypad Press ENTER e Time hours is highlighted 74 ADVANCED OPERATIONS Multi Step Program Continued Entering a New Program Continued Programming by Volume and Time Continued 3 To enter hours use numeric keypad Press ENTER e Time minutes is highlighted 4 To enter minut
45. TER NOTE The Loading Dose VTBI must be less than the primary VTBI 6 To start Loading Dose infusion press on 88 ADVANCED OPERATIONS Loading Dose Continued Making Changes During Loading Dose Program Select the desired channel as necessary The channel does not need to be on hold to change settings for Loading Dose Rate or VTBI 1 Press soft key next to parameter to be edited Changing Loading Dose a Infusion Rate e Current value is highlighted Changing Loading Dose Volume To Be Infused v m S mm Z V GADNVACV 2 To enter new value use numeric keypad 3 To accept new value s press ENTER Viewing or Changing Primary Settings During Loading Dose Infusion 1 Select desired channel as necessary 2 Press Primary Settings soft key e Primary rate Pri Rate primary volume to be infused Pri VTBI and total volume infused Total VI are displayed e Display returns to normal Loading Dose page after six seconds ADVANCED OPERATIONS 89 Loading Dose Continued Viewing or Changing Primary Settings During Loading Dose Infusion Continued 3 Press soft key for Pri Rate Pri VTBI or Total VI to Changing Primary Rate During Loading Dose Infusion e freeze display e highlight value NOTE If the flow sensor option is in use VTBI can be turned off by Changing Primary VTBI During selecting VTBI
46. To enter dose frequency time Interval from start of one dose until start of next use numeric keypad Press ENTER 9 To approve all information press ok soft key e f Dose Complete Alert Option is enabled DOSE COMPLETE ALERT OPTION page appears 10 To select On or Off use soft keys 82 ADVANCED OPERATIONS Multi Dose Program Continued Entering a New Program Continued To advance to time until first dose page press ok soft key NOTE All doses must be programmed to start within 24 hours e To start first dose immediately proceed to Starting First Dose Immediately After Programming section e To delay start of first dose proceed to Delaying Start of First Dose section Starting First Dose Immediately After Programming f A displayed time of 0 hours 0 minutes identifies that first dose will start immediately after programming 2 To approve and advance to main hold page press ok soft key 3 To start infusion press w or run soft key Delaying Start of First Dose P To enter number of hours until first dose use numeric keypad Press ENTER e Number of minutes is highlighted To enter number of minutes 0 to 59 until first dose use numeric keypad Press ENTER ADVANCED OPERATIONS 83 v m S am v GADNVACV Multi Dose Program Continued Entering a New Program Continued Delaying Start of F
47. Y Return To Loading Dose Prompt Return To Multi Dose Prompt Return To Multi Step Prompt Return To Secondary Prompt Secondary Complete Alert Sec Running Prompt Select Channel Prompt Dual channel instrument only Set Must Be Loaded Prompt Set Out Prompt Channel was turned off during a Loading Dose program NEW PATIENT no was selected during start up Channel was turned off during a Multi Dose program NEW PATIENT no was selected during start up Channel was turned off during a Multi Step program NEW PATIENT no was selected during start up Channel was turned off during secondary infusion NEW PATIENT no was selected during start up Secondary delivery has just been completed or was pressed while channel was running in secondary mode A key was pressed but no channel has been selected The AccuSlide Flow Regulator segment is not loaded in selected channel during a manual pressure baseline setting operation Pressure Baseline feature is O on The AccuSlide Flow Regulator segment is not installed correctly Press yes soft key to return to Loading Dose program or press no soft key to return to primary setup page Press yes soft key to return to Multi Dose program or press no soft key to return to primary setup page Press yes soft key to return to Multi Step program or press no soft key to return to primary setup page Press yes soft key to return
48. a Rate Accuracy Qualification Test 20000 Set Sensor Check Pressure Calibration Verification 00 00 c cece ete tt ee tere ene FUNCTION TOS ccc x actccasgacetaadedewaes ce auiasumdunsecewougneewnd pee aaia phd ds amedoneweciomedchewe ne FOU OW WS gee aren E E E EEE E E EEEE Ground Current Leakage Test unaandaa Il TABLE OF CONTENTS MAINTENANCE Continued CHECK IN AND CONFIGURATION Continued Ground Resistance Test 0 0 occ ccc eens Instrument Configuration 92 0 0 AORA ay r e eE EAEE SA AE oho Sadun seen sd ETE CLEANING EESE IE EESE EEE Air in Line Assembly 200000000000 occ ccc ccc eee INSPECTION REQUIREMENT Sorsi fevcuseeenenesetesiner se denezcnens SERVICE INFORMATION csusihos cee utes hen casey iss bes TEEN pEi Customer Service case cuonndanernecwhsseenenerannessaweraciuds Technical SUDDOLE iiics 2002002 b0s05eenensdddenionsesdabaseaace Product REUT ss eo caie uine sa tanne udns y eases eens aio WARRANTY ooa eea APPENDIX TRUMPET AND START UP CURVES naaa TABLE OF CONTENTS iil NOILVY 4dO TARY NSO DSS ES SNOILVYs4dO SadNlVss NOMONGOYLNI GADNVACV gt UO z 4 gt JINVNALNIVIA XIGNAddV GENERAL CONTACT INFORMATION Customer Advocacy For clinical and technical questions feedback and troubleshooting assistance Phone toll free within the United States and Canada 800 854 7128 Ext 7812 E Mail CustomerFeedback alarismed com Technical Suppor
49. ablished This may reduce maximum available pressure range User has attempted to increase pressure alarm limit to a level higher than configured maximum pressure Check administration set for probable cause kinked tubing closed clamp etc Press run soft key to restart infusion See Detection of Upstream Occlusion section for more information Verity selection and press ok soft key Turn panel lock off to access panel controls Panel lock key Is located behind handle Channel must be on hold to make changes Place instrument on hold before performing manual SET PRESSURE BASELINE operation Press and hold until display turns off Reload delivery set and verify no obstruction exists which could cause excess pressure e f Pressure Baseline feature Is on repeat manual setting of pressure baseline OTHERWISE e Restarting infusion will automatically set pressure baseline Choose a pressure alarm limit that Is less than or equal to contigured maximum pressure 36 BASIC SYSTEM OPERATION Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY Pressure Unstable Cannot Set Excessive variation In pressure Reduce or temporarily remove Baseline due to motion flow trom other sources of variation while Prompt instruments or blood pressure performing manual baseline prevents accurate setting of setting operation pressure baseline Pressure Baseline feature Is O on oP
50. al Systems service representative nN altered in any way so as to affect in ALARIS Medical Systems judgment the product s stability or reliability c subjected to misuse or negligence or accident or which has had the product s serial or lot number altered effaced or removed Or d improperly maintained or used in any manner other than in accordance with the written instructions furnished by ALARIS Medical Systems This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of ALARIS Medical Systems and ALARIS Medical Systems does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of ALARIS Medical Systems any other liability in connection with the sale or use of ALARIS Medical Systems products ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION lt gt 2 m Z gt Z A m See packing inserts for international warranty if applicable MAINTENANCE 117 THIS PAGE INTENTIONALLY LEFT BLANK 118 MAINTENANCE APPENDIX Trumpet and Start Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND START UP CURVES In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual administration sets cause short term fluc
51. arts water 4 Flow sensor should be routinely cleaned by running warm CAUTION water over it while actuating slider and then thoroughly dred Do not use solvents or cleaning agents Damage to plastic parts of the case or flow sensor could occur DO NOT use solutions containing aromatic solvents naphtha paint thinner etc chlorinated solvents Trichloroethane MEK Toluene etc alcohol or phosphoric acid DO NOT use hard or pointed objects or pressurized sprays to clean any part of instrument DO NOT steam autoclave EtO sterilize or immerse instrument DO NOT use pressurized sprays on Instrument lt gt 2 m Z gt Z A m Excluding 10 bleach solution in water MAINTENANCE 113 Cleaning Continued Air in Line Assembly It may be necessary from time to time to clean the Air in Line CAUTION Detector so that optimal contact is maintained between the detection system and the IV tubing This allows the ultrasound emitter in the Air in Line Arm to send a clear signal through the IV tubing to the receiver Cleaning can be accomplished using a cotton tipped applicator moistened with water as follows Do not use solvents or chemical cleaners 1 Open instrument latch 2 Moisten a cotton tipped applicator with warm water EEEE J a Latch Opened 3 Place cotton tip over Air in Line Detector see illustration to right Cotton Tipped
52. ation 96 hours or less anesthetic epidural drug delivery e Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery BASIC SYSTEM OPERATION 11 Warnings and Cautions Continued CAUTION Prior to use ALARIS Medical Systems recommends that users become familiar with the instrument the administration sets and any accessories that may be used ANNA This instrument is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected Itis neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions ANNA Hospital personnel must ensure the compatibility of the drugs as well as the performance of each instrument as part of the overall infusion Potential hazards include drug interactions inappropriate delivery rates and pressure alarms GUIS The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site may impede the flow of common gravity only systems affecting their performance hospital personnel must ensure the performance of the common IV site is satisfactory under these circumstances GUIS Each time the instrument Is turned on verity and or set the monitoring mode resistance alert and or pressure alarm limit I
53. be affected by catheter type Refer to Appendix Trumpet and Start up Curves for data on how certain factors influence rate accuracy Volume Infused Range 0 0 to 9999 9 mL in 0 1 mL increments Volume To Be Infused Range 0 1 to 9999 9 mL in 0 1 mL increments primary and dose rate modes 0 1 to 999 9 mL in 0 1 mL increments all other modes lt gt 2 Z gt Z A O NOTE The Signature Edition Pump has been assessed and complies with the following Technical Standards IEC 60601 1 BS 5724 including amendments A1 and A2 IEC 60601 2 24 CISPR 11 Group 1 Class B Emissions IEC 60601 T 2 MAINTENANCE 103 Configurable Options The following features can be customized by qualified service personnel in the Configuration and Diagnostics Modes Feature Air in Line Air in Line Accumulator Air in Line Alarm Threshold Air in Line Reset Audio Transition Tone Volumes Computer Link Baud Rate Mode Parity Dynamic Monitoring Auto Restart Plus Monitoring Options Trends Pressure Manual Pressure Baseline Pressure Alarm Pressure Display Pressure Limit Initial Configuration Mode Def Alarm Pressure Limit Maximum Resistance Default Resistance Alert Resistance Alert Resistance Display Resistance Pressure Setting Instrument ID Instrument Label KVO Rate Maintenance Maintenance Interval Maintenance Reminder Optional Modes Dose Rate Calculator Loading Dose
54. ble Pressure option is selected pressure system accuracy can be enhanced by ensuring no occlusion or other pressure source exists in IV line when activating RUN HOLD NOTES e Pressure alarm limits may be adjusted using the soft keys located below the arrow symbols See Adjustable Pressure Alarm section e Maximum pressure limit settings may be configured by qualified service personnel GUS Each time the instrument is turned on verity and or set the monitoring mode resistance alert and or pressure alarm limit If the monitoring mode resistance alert and or pressure alarm limit are not verified the instrument may not be operating with the desired occlusion detection parameter s ADVANCED OPERATIONS 43 SNOILVdsdO GADNVACV Dynamic Monitoring System Continued Monitoring Options Resistance Mode Detection of Downstream Occlusions In the Resistance or High Resistance monitoring mode a RESISTANCE ALERT condition occurs when the measured resistance reaches the alert limit An OCCLUSION DOWNSTREAM condition is detected when 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 will also be detected when the configured pressure limit is exceeded This limit
55. btained by calling one of the following Customer Service numbers United States Canada UK Freephone Fax Technical Support Technical support service information applications and manuals may be obtained by contacting an ALARIS Medical Systems representative United States Canada Eastern Western UK Freephone When submitting any request for service include e a description of difficulty experienced e instrument settings e administration set lot number e solution s used e message displayed at time of difficulty Product Return If it is necessary to return the instrument for service obtain a return authorization number prior to shipment Carefully package the instrument preferably in the original packaging reference the return authorization information and return it to the appropriate service or distribution center ALARIS Medical Systems does not assume any responsibility for loss of or damage to returned instruments while in transit 800 482 4822 800 387 8309 0800 917 8776 01256 330 860 800 854 7128 extension 6003 800 908 9918 800 908 9919 0800 389 6972 116 MAINTENANCE WARRANTY ALARIS Medical Systems Inc hereinafter referred to as ALARIS Medical Systems warrants that A Each new ALARIS Medical Systems Signature Edition Pump excluding the battery is free from defects in material and workmanship under normal use and service for a period of two 2 year
56. catheter wait at least five seconds after loading set before activating RA This allows pressure generated by loading process to dissipate and sensor to stabilize Very small PICC catheters such as 28 gauge 1 2 French may require 60 seconds or more for stabilization e When multiple instruments are infusing through a common small diameter catheter pressure measurement accuracy can be optimized by temporarily stopping all infusions then restarting all instruments beginning with instrument delivering at lowest rate Pressure Baseline The Pressure Baseline feature provides a real time bar graph and numeric display of line pressure Qualified service personnel can turn this feature off or on GADNVACV v m S m v NOTE The pressure limit may be reduced clipped if the pressure in the line is high or changing This results in the pressure limit being lowered from the selected setting If this occurs first try to remove or reduce the downstream pressure Following that try to reload the set wait 15 to 30 seconds and then perform a Set Pressure Baseline operation The pressure baseline may need to be set a second time after the pressure readings have stabilized If this does not work the set could be the cause of this clipping Manually Setting Pressure Baseline While Operating in Adjustable Pressure Mode NOTES e For dual channel instruments select the desired channel as necessary The press
57. cation Test Rate Verification e Set Sensor Check Pressure Calibration Verification e Functional Test e Flow Stop Test e Ground Current Leakage Test e Ground Resistance Test e Instrument Configuration References used in conjunction with this document e 710X 720X Series Technical Service Manual e Service Bulletin 490 or most current version Release of Software Version 4 06 7130 7230 e Service Bulletin 495 or most current version Release of Software Version 4 08 7131 7231 Rate Accuracy Qualification Test This procedure is to be used only for the testing of an instrument during New Instrument Check In or when just received from the Service Depot Center Rate accuracy of a properly calibrated Signature Edition Pump is 5 95 of the time with 95 confidence Refer to the Trumpet and Start Up Curves in the Appendix for additional information This test is to verify that damage or changes to the instrument did not occur during shipment and handling 106 MAINTENANCE Check In and Configuration Continued Rate Accuracy Qualification Test Continued NOTES Rate accuracy of the Signature Edition Pump should be tested using a Model 80VCS Calibration Set The system is designed to produce overall accuracy of 5 for rates greater than 1 mL h and up to 999 9 mL h and 6 5 for rates equal to or less than 1 mL h 95 of the time with 95 confidence The system performance with a calibration
58. cators Indicate a channel is in alarm and has stopped infusing Infusing Indicators Indicate a channel is infusing RUNeHOLD Keys Start and stop infusion on selected channel To restart channel must be selected Power Indicator g Green Plugged in and charging TA S A B A Flashing Amber Battery power E m i POWER Keys Turn channels on and off Primary PRI Key Selects I eee T KVO OPT HLD PRI S zoa primary mode channe za OPTIONS Key Accesses additional must be selected ATB ee AW ES SEC Key Selects secondary mode channel must be selected PRI SEC HLD OPT KVO Split Screen Key Displays information for both channels when both channels are infusing Soft Keys Refer to Main LCD Display in Displays section of this chapter entered Silence Key Silences audible alarm or alert for two minutes message remains on screen New alarm or alert will reinstate audible tone Clear Key Clears selected numeric value Audio Volume Key Sets audio volume for alarms alerts and KVO tone Press key to adjust volume Numeric Keypad Enters changes values 4 INTRODUCTION Displays Main LCD Display The Main LCD Display is backlit for easy viewing The backlight CAUTION dims when operating on battery power as an energy saving feature Pressing any key automatically turns the backlight up again Appearance of lines and or dots tha
59. ce inspections listed are recommended Battery Refresh Cycle iz monthe in accordance with ALARIS Medical Systems requirements and Flow Stop Test imoni guidelines Customers within the United States and Canada Eunctonal Test EA A should note that these inspections are also intended to T complement the intent of the Joint Commission on the Leakage Test 12 months Accreditation of Healthcare Organizations requirements Ground Restanca Tesi i manths For detailed instructions on performing preventive maintenance Pressure Calibration 12 months inspections and maintenance refer to the Technical Service Rate Accuracy Calibration 12 months Manual and supplemental service bulletins A service agreement Regular Inspection 12 months may be obtained from ALARIS Medical Systems for the Reset Time 12 months performance of all required periodic inspections lt gt 2 Z gt Z A O For more information see the Service Information section of this document MAINTENANCE 115 Service Information NOTE Ifthe instrument shows evidence of damage in transit notify the carrier s agent immediately Do not return damaged equipment to the factory before the carrier s agent has authorized repatrs If the instrument fails to respond as described in this document and the cause cannot be determined do not use the instrument Contact qualified ALARIS Medical Systems service personnel Customer Service Information or assistance may be o
60. d for a short interval Viewing or Editing Multi Step Program The channel must be on hold to view or edit the steps in the program 1 To place channel on hold press aN SNOILVdsdO GADNVACV 2 To return to review page s press setup soft key e A tick mark W next to a step on review page s indicates it has not started e Only steps having a can be edited e Completed steps or a step in progress will not have a E e A step number in progress is highlighted 3 To advance through review page s of program press ok soft key ADVANCED OPERATIONS 7 7 Multi Step Program Continued Making Changes During Multi Step Program Continued Viewing or Editing Multi Step Program Continued 4 To select a step for editing press a soft key e Step setup page is displayed 5 To select value for editing press a soft key 6 To enter new value use numeric keypad Press ENTER 7 When programming is complete and to return to review page s press ok soft key 8 To approve review page s and STEP TOTALS page press ok soft key 9 To resume infusion press or run soft key 78 ADVANCED OPERATIONS Resuming an Interrupted Multi Step Program Multi Step Program Continued The channel retains its place in the program if the instrument is turned off The program can be restarted from STEP 1 or resumed where it left off 1 Fo
61. d path is unobstructed Ensure air in line sensors are thoroughly cleaned Refer to Cleaning section in this document for further instructions Evaluate air in set Remove air It 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 verity upstream fluid path is unobstructed Ensure air in line sensors are thoroughly cleaned Refer to Cleaning section in this document for further instructions Plug power cord into an AC outlet immediately Press run soft key or FAT to resume infusion Plug power cord into an AC outlet as soon as possible Both channels must be infusing for split screen feature to operate BASIC SYSTEM OPERATION 31 gt GH AL a EY alr St lt Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY CHANNEL MALFUNCTION A Alarm Dual channel instrument only Channel Not On Prompt Dual channel instrument only Checking Line Alert Complete Entry Alert Complete or OK Setup Prompt COMPUTER LINK FAILURE Q Alarm Dose Complete Alert Dose Out of Range Prompt Channel malfunction Channel s R95 or was pressed but channel is not on Flow has been obstructed Auto Restart Plus Feature IS ON was not pressed to accept a new value was pressed before setup was completed or okayed RS 232 connection to computer was di
62. ded on the Set Compatibility Card e Before operating the instrument verify that the administration set is free from kinks and is installed correctly in the instrument e ALARIS Medical Systems 72 Series administration sets are supplied with a sterile fluid path for one time use only Do not resterilize e For set replacement interval refer to facility protocol and or government standards such as CDC guidelines in the United States e Fluid path is STERILE and NONPYROGENIC e Discard if packaging Is not intact or protector caps are unattached e For IV push medication put instrument on hold clamp tubing above the port Use only ALARIS Medical Systems 72 Series administration sets The use of any other set may cause improper instrument operation resulting in inaccurate fluid delivery or other potential hazard BASIC SYSTEM OPERATION 13 NOITAA E eLO INALSAS DISvga Warnings and Cautions Continued User Precautions Continued Administration Sets Continued e Flush port s per facility protocol e Discard administration set per facility protocol SmartSite Needle Free System e SmartSite Needle Free Valve Port is contraindicated for blunt cannula systems e Swab top of SmartSite Needle Free Valve Port with preferred antiseptic prior to each access NOTES e f applicable attach syringe to SmartSite Needle Free Valve Port and aspirate minute air bubbles e nan emergenc
63. e press ok soft key 9 To start infusion press 5 or run soft key Calculating Dose Rate 1 To move highlight to volumetric rate press Rate soft key To enter rate use numeric keypad Press ENTER e Concentration is highlighted 2 To enter concentration use numeric keypad Press ENTER e Diluent volume is highlighted ADVANCED OPERATIONS 63 SNOILVYsdO GADNVACV Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued Calculating Dose Rate Continued 3 Toenter diluent volume use numeric keypad Press ENTER e f applicable patient weight and or height is highlighted To enter weight and or height use numeric keypad Press co e Instrument automatically calculates and displays dose rate NOTE TTTTT or WY appears if a calculated value is outside the display s range e Use soft key to highlight value to be edited e Use numeric keypad to enter value e Press to accept change 5 Verity all values and units To approve all calculated and displayed information press ok soft key NOTE If the channel is running in the primary mode while setting up the calculation proceed to the last step in this section e Next setup page appears e VTBI is highlighted 64 ADVANCED OPERATIONS Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued Calculating Dos
64. e Rate Continued 6 To enter VTBI use numeric keypad Press ENTER NOTE Ifthe flow sensor option is being used Dose Rate VTBI can be turned off by selecting VTBI then pressing CLEAR OR Dose Rate VTBI can be deleted from VTBI VI screen and main hold page Configurable Options e VI is highlighted 7 To clear VI press or O zero key Press ENTER J 8 To approve all displayed information and advance to main hold page press ok soft key 9 To start infusion press or run soft key NOTE For instruments with European selected as the SP Regional Setting Dose Calculator is displayed as the channel label instead of the drug name or Drug Making Changes During DRC Program Select the desired channel as necessary The channel does not need to be on hold to change volumetric rate dose rate or VTBI to clear the VI or to view more information NOTE The instrument recalculates the program values if the volumetric or dose rate drug amount diluent volume weight or height are changed ADVANCED OPERATIONS 65 ae S mn Z U GADNVACV Drug Specific Dose Rate Calculator DRC Continued Making Changes During DRC Program Continued Press I soft key e Additional Dose Rate setup information is displayed for a short interval Changing Volumetric Rate or Dose Rate 1 To highlight value press Rate or Dose soft ke
65. e Signature Edition Pump provides enhanced flow continuity at rates below 50 mL h Selecting Monitoring Option NOTE For dual channel instruments select the desired channel as necessary The bar graph and numeric displays are not available when the split screen is displayed 1 Press oPtions e Options page appears 2 Press Monitoring Options soft key e Monitoring Options page appears 3 Press soft key for Resistance High Resistance or Adjustable Pressure NOTE lf pressure limit adjustment is available selection will read Adjustable Pressure otherwise it reads Pressure 42 ADVANCED OPERATIONS Dynamic Monitoring System Continued Monitoring Options General Continued Selecting Monitoring Option Continued 4 Press ok soft key Display automatically returns to normal operating screen NOTE While the channel is on the selected option resistance alert and pressure alarm thresholds will remain in effect until changed by the operator a If Resistance option is selected Resistance displays below bar graph while infusing NOTE Resistance alert limit may be adjusted using the soft keys located below the arrow symbols See Resistance Alert section b If High Resistance option is selected Hi Resist displays below bar graph while infusing NOTE High Resistance alert limit may be adjusted using the soft keys located below the arrow symbols c If Adjusta
66. e a 100 coverage braid foil shield attached to the connector housings around the signal conductors with the cable jacket Qualified service personnel can turn the Computer Link feature on or off 98 ADDITIONAL FEATURES RS 232 Computer Link Continued Connecting to a Computer 1 Press otions e Options page appears 2 To view additional selections press page soft key 3 Press Computer Link soft key e Computer Link page appears 4 Press Monitor soft key 5 Press ok soft key RS 232 6 Connect an RS 232 cable from hospital computer to 8 4 yy on instrument s back panel GOLD e During communication between host computer and peppa instrument MNTR Monitor Mode appears in lower LCD a gt ov ea O rs ie n gt gt e f communication is interrupted MNTR Monitor Mode flashes for 60 seconds NOTE MNTR remains in the lower display once the mode is selected and communication with the computer has been established ADDITIONAL FEATURES 99 RS 232 Computer Link Continued Disconnecting from a Computer 1 Press oPtions e Options page appears 2 To view additional selections press page soft key 3 Press Computer Link soft key e Computer Link page appears 4 Press Off soft key 5 Press ok soft key 100 ADDITIONAL FEATURES Specifications MAINTENANCE r S Pecican Administration Sets Use only AL
67. ear after one minute and be replaced with a split screen display if both channels are infusing Monitoring Options Pressure Mode Detection of Downstream Occlusions When using the Adjustable Pressure monitoring mode a pressure alarm limit may be selected in 25 mmHg increments from 25 mmHg to the maximum configured pressure limit When measured pressure exceeds this level an OCCLUSION DOWNSTREAM condition exists 48 ADVANCED OPERATIONS Dynamic Monitoring System Continued Monitoring Options Pressure Continued Detection of Downstream Occlusions Continued When a Downstream Occlusion is detected one of the following occurs e f Auto Restart Plus feature is on instrument notifies clinician with a Checking Line message and audible tone See the following section Auto Restart Plus Feature for further details e f Auto Restart Plus feature is off instrument notifies clinician with an OCCLUSION DOWNSTREAM alarm Auto Restart Plus Feature SNOILvVH JdO GADNVACV The Auto Restart Plus feature provides the ability to automatically continue an infusion if downstream pressure measurements indicate that an occlusion condition has cleared within a 40 second Checking Line period excluding High Resistance Monitoring Mode The Checking Line message and tone are presented whenever a pressure measurement exceeds the selected alarm threshold It the pressure falls to
68. em and exercise vigilance in its utilization WARN NG A warning is an alert to potential serious outcomes death injury or serious adverse events to the patient or user CAUTION A caution is an alert to take special care for the sate and effective use of the device Warnings and Cautions To ensure proper performance of the Signature Edition Pump and to reduce potential injury observe the following precautions Epidural Administration WARNING gt lt a ay EY alr am lt The instrument can be used for epidural administration of Epidural administration of drugs anesthetic and analgesic drugs This application is only other than those indicated for appropriate when using analgesics and anesthetics labeled epidural use could result in serious for continuous epidural administration and catheters injury to the patient intended specifically for epidural use Use only an ALARIS Medical Systems 72 Series administration set without a Y WARNING connector or injection port for epidural infusions The instrument s secondary features must not be used when the Ay o P Aa instrument is being used for epidural administration of e r ne T A and administration set used for anesthetic and analgesic drugs epidural drug delivery be clearly e Epidural administration of anesthetic drugs Use differentiated from those used for indwelling catheters specifically indicated for short term other types of administr
69. es 0 59 if desired use numeric keypad Press ENTER e Instrument automatically calculates and displays volumetric rate 5 To approve all displayed information and advance to STEP 2 of infusion profile press ok soft key 6 To set up each additional step of infusion profile repeat steps 1 through 4 7 When all steps have been entered and ok d press done soft key e Review page s display three profile steps at a time 8 To approve and advance through review page s press ok soft key 9 To clear VI if desired press or 0 zero key Press co ADVANCED OPERATIONS 7 5 SNOILVYs4dO GADNVACV Multi Step Program Continued Entering a New Program Continued Programming by Volume and Time Continued 10 To approve STEP TOTALS page press ok soft key e Main hold page is displayed 11 To start Multi Step infusion program press 9N or run soft key Making Changes During Multi Step Program Select the desired channel as necessary The channel does not need to be on hold to clear the VI or to view the totals remaining Clearing Volume Infused 1 Press VI soft key 2 Press or 0 zero key 3 Press ENTER 76 ADVANCED OPERATIONS Multi Step Program Continued Making Changes During Multi Step Program Continued Viewing Totals Remaining in Multi Step Program Press I soft key e Time and VTBI remaining in Multi Step program are displaye
70. es illustrated may not have been enabled on the instrument Battery Management System The Battery Management System incorporates features which enhance battery maintenance in order to maximize the life of the battery reduce associated costs and increase instrument availability The system provides e Green W lights when instrument is plugged in e Amber flashes when instrument is operating on battery power e Automatic battery power if instrument is unplugged or in the event of a power failure e Low battery alert indicates battery depletion is imminent beginning at least 30 minutes prior to a BATTERY DEPLETED alarm Maximum battery capacity as well as gauge accuracy is reached after several complete charge discharge recharge cycles in the refresh process ALARIS Medical Systems recommends that the battery be fully charged discharged recharged using the retresh cycle before placing the instrument in use Refer to the Technical Service Manual for detailed information on the refresh cycle 2 gt I T oo _ gy D ma The gauge indicates approximate battery run time remaining aA ie under current operating conditions It is located in the lower GOLD display and is always on To ensure a more accurate battery pE pap gauge reading review the remaining battery run time five minutes after starting an infusion The gauge updates for each program change while infusing NOTES e Battery run
71. ettings qo w e Panel Locked appears in Main LCD Display if any other key IS pressed E pnpa s3J NL1Vdd IWNOILIGGV Turning Panel Lock Feature Off Press and hold until 8 in lower display disappears NOTE To make changes or respond to an alarm the panel lock must be turned off pmm ADDITIONAL FEATURES 95 Pole Clamp NOTE The illustrated pole clamp knob may not reflect the knob in use on the instrument 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 e 360 rotation in 90 increments e ergonomically designed knob e accommodates diameters from 15 to 35 millimeters e no restrictions for pole mounting except physical space NOTE When using multiple instruments care should be taken to evenly distribute the instruments to ensure stability Changing Pole Clamp Orientation l NOTE The illustrated pole clamp knob may not reflect the knob in use on the instrument 1 Press and hold rotation lever p 5 P qm I w C d To ensure proper occlusion detection DO NOT operate the instrument tilted back more than 45 from the upright position Lever 2 Reposition clamp 3 Release lever at desired position
72. f the monitoring mode resistance alert and or pressure alarm limit are not veritied the instrument may not be operating with the desired occlusion detection parameter s GUIS References in this document to specific drugs and drug doses are for example only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages 12 BASIC SYSTEM OPERATION Warnings and Cautions Continued Parallel Infusions There are no contraindications regarding the use of the Signature Edition Pump with any other positive displacement infusion device when ported together into a common IV site location User Precautions To ensure proper performance of the instrument and to reduce potential injury to the operator observe the following precautions e Disconnect from main AC and battery power when performing maintenance e Do not open the instrument case There are no user serviceable parts inside The case should only be opened by qualified service personnel using proper grounding techniques When the case is opened an electrical shock hazard exists which can result in serious injury to persons and instrument component damage e The power cord must be connected to a properly grounded three wire receptacle Hospital Grade Administration Sets e A list of approved administration sets recommended by ALARIS Medical Systems for use with the Signature Edition Pump is provi
73. f current primary infusion rate is appropriate press ENTER OR To enter a new Infusion rate use numeric keypad Press ENTER e Primary VTBI is highlighted If current primary VTBI is appropriate press ENTER OR To enter a new VTBI use numeric keypad Press ENTER e VI is highlighted NOTE If the flow sensor option is in use VTBI can be turned OFF by selecting VTBI pressing and then ENTER J OR The primary VTBI can be deleted from the primary mode setup page Configurable Options If there is a VI value that needs to be cleared press or O zero key Press ENTER e If cleared volume infused is reset to 0 0 mL To start primary infusion verity programming parameters and then press channel s AD e Channel s infusing indicators light e After starting infusion verity flow from IV container NOTE Prerun prompts may appear if the start up procedures were not completed Refer to the Alarms Alerts and Prompts section of this document to determine the appropriate action BASIC SYSTEM OPERATION 19 NOIR ATA E eLO WNJ3LSAS DISvg Primary Infusion Continued Making Changes During Primary Infusion Select the desired channel A B as necessary The channel does not need to be on hold to change the settings for Rate or VTBI or to clear the VI 1 Press soft key next to parameter
74. fer to the test equipment s operation manual for the proper setup and measurement technique Resistance must be lt 0 10Q Instrument Configuration Refer to the Checkout and Configuration chapter in the service manual and Service Bulletin 490 or 495 or most current version for the procedure and options Plug the instrument into an AC outlet during storage to ensure a fully charged battery when needed Do not connect the ground resistance probe to the pressure transducer e AC indicator light will be green whenever instrument is plugged in Close the latch es whenever the instrument is not in use s ies a 112 MAINTENANCE 1 Unplug power cord trom AC outlet before cleaning CAUTION DO NOT SPRAY onto or immerse the instrument in fluids Cleaning solutions should be applied to the instrument with a soft cloth 2 Verify RS 232 connector is covered Do not spray fluid directly into any connector 3 Use a soft cloth dampened with warm water and a mild nonabrasive cleaning solution e A soft bristled brush may be used to clean narrow areas e Use light pressure when cleaning pressure transducer and air in line detector areas of pumping channels e Acceptable cleaning solutions use per manufacturers instructions Warm water Vesphene Manu Klenz cleaning only 10 Bleach Solution 7part bleach to 9 p
75. forms a self test All indicators and displays momentarily light An audio tone sounds e System start up page is momentarily displayed NOTE XX XX in the illustrated start up page represents the current software revision e Hold indicator flashes WARNING Each time the instrument is turned on verify and or set the monitoring mode resistance alert and or pressure alarm limit If the monitoring mode resistance alert and or pressure alarm limit are not verified the instrument may not be operating with the desired occlusion detection parameter s CAUTION Appearance of lines and or dots that remain on constantly when the device is powered on may Indicate improper functioning of the Main LCD Display Although the instrument Is functioning properly return it to qualitied service personnel e When self test is complete NEW PATIENT screen appears 2 To retain previous infusion parameters press no soft key NOTE Infusion parameters rate VTBI etc are retained in memory unless all power is lost no AC and a depleted battery OR To clear all infusion parameters from memory press yes soft key e Primary setup page Is displayed and instrument is ready for programming 18 BASIC SYSTEM OPERATION Primary Infusion Ti Follow Start Up steps e Primary setup page appears e Primary infusion rate Is highlighted I
76. g label The Signature Edition GOLD Infusion Pump has been tested and complies with IEC 60601 1 Amendment 2 Clause 17 h for Defibrillator Proof Equipment Explosion risk if used in presence of flammable anesthetics Flow sensor receptacle optional channel A Flow sensor receptacle optional channel B Infusing indicator Indicates degree of protection liquid ingress Manufacturing Date Number adjacent to symbol indicates month and year of manufacture Nurse Call optional for 7130 7230 Consult operating instructions 8 INTRODUCTION Symbols and Terms Continued Panel lock Green instrument plugged into AC power and battery being charged Flashing amber instrument running on battery power and battery being depleted AR RS 232 RS 232 connector Z JJ J N Z CAUTION Federal U S A law restricts this device to sale by or on the order of a physician Silence mode 078 Split screen dual channel instrument only Transition Tone A brief tone during transition from one mode to another Canadian Certification Mark Products bearing this mark have been tested and certified in UL Class accordance with applicable Canadian electrical safety and performance standards ESA C22 2 No 125 U S Certification Mark Products bearing this mark have been tested and certified in accordance with applicable U S electrical safety and performance standards UL
77. ids medications blood and blood products The ALARIS Medical Systems Infusion Pumps covered in this document 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 Signature Edition Pump uses a wide variety of AccuSlide Flow Regulator administration sets The ALARIS Medical Systems 72 Series administration sets are designed for use with the instruments as well as for gravity flow stand alone use The unique patented Accuslide Flow Regulator has an integral flow control device that minimizes accidental free flow when the set is removed from the instrument and provides accurate rate control during gravity administration Qualified service personnel can configure many features of the instrument to meet specialized needs The ol symbol is used throughout this document to indicate the configurable options Refer to the Configurable Options section in the Maintenance chapter of this document for a list of the contigurable options and their default settings Refer to the Technical Service Manual for the procedure to set selected configuration parameters INTRODUCTION 1 New User Interface Features The user interface differences between Instruments having Version 2 78 software and those having Version 4 06 North America
78. infusing Battery run time may be affected by the operating mode rate monitoring options and back pressure 6 INTRODUCTION Around the Instruments Panel Lock Key Handle RS 232 Connector Cover Z JJ J N O Z Flow Sensor Receptacle s RS 232 Connector Pole Clamp Pole Clamp Knob illustration may not reflect knob in use on the instrument Pole Clamp Rotation lever Battery Door Potential Equalization Connector 7131 7231 Power Cord Latch Flow Control Actuator Pressure Transducer Air in Line Detector Loading Guide Air in Line Arm INTRODUCTION 7 Symbols and Terms A A m Eg 0086 g Alarm indicator Attention Refer to accompanying documentation Audio volume Approximate battery time remaining under current infusing conditions Battery gauge does not represent battery time remaining when instrument is turned off Conformit Europ enne CE Marking notified body 0086 British Standards Institution Contigurable Option Electrical shock protection rating Type CF Electrical shock protection rating Type CF Detibrillation Proof NOTE Depending on manufacturing and distribution timing the Signature Edition GOLD Infusion Pump may bear either the CF or CF Defibrillator Proof symbol on the main ratin
79. irst Dose Continued 3 To advance to timer hold page press start timer soft key e Hourglass icon flashes to indicate timer is counting down to start of dose e Dose automatically starts its infusion when timer reaches 0 hours 0 minutes 4 To see Multi Dose programmed information press amp soft key Making Changes During Multi Dose Program Select the desired channel as necessary The channel does not need to be on hold to view more information Viewing More Information on Multi Dose Setup Press amp soft key e Additional Multi Dose setup information is displayed for a short interval 84 ADVANCED OPERATIONS Multi Dose Program Continued Making Changes During Multi Dose Program Continued Changing Time Interval Until Next Dose 1 Press stop timer soft key 2 To select a value for editing press a soft key 3 To enter new value use numeric keypad Press ENTER SNOILVYsdO GADNVACV 4 When editing is complete press start timer soft key Resuming an Interrupted Multi Dose Program 1 Follow Start Up Sequence steps and select NEW PATIENT no NOTE If resuming an infusion on a dual channel instrument with an infusion currently running NEW PATIENT screen does not appear e Return To Multi Dose page appears 2 Press yes soft key e Pressing no soft key returns screen to primary setup page ADVANCED OPERATIONS 85
80. larm or was pressed while running in Dose Rate program An invalid value was entered during programming Flow sensor is unplugged from back of instrument Channel has been on hold for two minutes and no keys have been pressed on either channel if dual channel VTBI has counted down to zero Channel is in KVO mode Instrument malfunction Fora dual channel instrument neither channel is functional Instrument channel has not performed self check within programmed interval Instrument has calculated a rate less than 0 1 mL h A key is stuck or was held down too long Channel must be on hold to change modes Press or 0 key to clear entry Enter appropriate value Plug tlow sensor into flow sensor receptacle Press hold soft key to return to hold mode Put channel on hold to reenter a primary VTBI Change solution container if necessary OR Terminate infusion Turn instrument off and then on It problem persists do not use instrument Contact qualified service personnel If set is loaded Eject set wait five seconds and then reload set If no set is loaded Load set wait one minute and then eject set Wait five seconds and then reload set Verity and reenter settings Release key Turn instrument off both channels if dual channel instrument and then on If problem persists do not use instrument Contact qualified service personnel BASIC SYSTEM OPERATION 33 gt GH
81. llow Start Up Sequence steps and select NEW PATIENT no NOTE If resuming an infusion on a dual channel instrument with an infusion currently running NEW PATIENT screen does not appear e Return To Multi Step page appears 2 Press yes soft key e Pressing no soft key returns screen to primary setup page 3 Press Review Resume soft key e STEP In Progress page appears 4 To resume program from point of interruption press Continue Program soft key OR To restart program at beginning of STEP 1 press Restart Program soft key e Review page s appears 5 Verity all settings are correct If a change is required refer to Making Changes During Multi Step Program section 6 To approve review page s and STEP TOTALS page press ok soft key ADVANCED OPERATIONS 79 SNOILVasdO GADNVACV Multi Step Program Continued Resuming an Interrupted Multi Step Program Continued 7 To continue or restart program press 55 or run soft key Quitting Multi Step Program The channel must be on hold 1 Press menu soft key 2 To return to primary setup page press Quit Program soft key NOTE Primary setup page parameters may be different from the MULTI STEP MENU Verify all parameters prior to resuming infusion Multi Dose Program This feature permits the clinician to preprogram 1 to 24 infusions with the same rate and volume o
82. lower to shorten time to alarm Pressure Monitoring Using Automatic Baseline Calibration NOTE The auto pressure baseline calibration will remain in effect until the instrument is turned off the latch is opened the set is reloaded or the Set Pressure Baseline function is performed e First activation of for a new infusion automatically establishes a pressure baseline based on current system pressure Instrument maintains an optimal baseline upon subsequent activations of La as follows gt If current system pressure is same or higher than original baseline pressure baseline will not change gt If current system pressure is less than original baseline system will automatically reset to new system pressure value e Pressure measurement can be optimized particularly at low flow rates less than 3 mL h by pausing and restarting at least once every two hours for example when reprogramming VTBI This allows pressure baseline to calibrate based on current system pressure e Prior to activation of ensure that pressure has not built up in IV line due to either occlusion or flow from other instruments through a common catheter This will result in a more accurate pressure measurement 50 ADVANCED OPERATIONS Dynamic Monitoring System Continued Adjustable Pressure Alarm Continued Pressure Monitoring Using Automatic Baseline Calibration Continued e When loading a set connected to a small diameter
83. ly display present alert level marker press either 4 or P 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 If Flow Resistance Exceeds Alert Level Marker It flow resistance exceeds the alert level marker a Resistance Alert message displays and an alert tone sounds The channel will continue to infuse and the message and tone will continue until one of the following occurs e Resistance of IV line site falls below Alert level marker e Resistance Alert level marker is increased above current measured resistance value e Resistance rises to 100 initiating a Checking Line or OCCLUSION DOWNSTREAM condition 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 Qualified service personnel can turn this feature off or on Downstream Occlusions are indicated by a tick mark f at the top of the trend screen Viewing Resistance Mode Trend Graphs NOTE For dual channel instruments select the desired channel as necessary The trend graph is not available while the split screen is displayed 1 Press oPtions e Options page appears 46 ADVANCED OPERATIONS Dynamic Monitoring
84. mary Settings soft key e Primary rate PriRate primary volume to be infused Pri VTBI and total volume infused Total VI are displayed e Display returns to normal secondary page after six seconds 2 Press soft key for Pri Rate Pri VTBI or Total VI to Changing Primary e freeze display Infusion Rate e highlight value 24 BASIC SYSTEM OPERATION Secondary Infusion Continued Viewing or Changing Primary Settings During Secondary Infusion Continued Changing Primary VTBI NOTE Ifthe flow sensor option is in use VTBI can be turned OFF by selecting VTBI pressing and then ENTER OR The primary VTBI can be deleted from the primary mode setup page Configurable Options 3 To enter new value s use numeric keypad 4 To accept new value s press ENTER Clearing Volume Infused 1 Press Total VI soft key gt a U SU alr St lt e Current value is highlighted NO To reset volume infused to 0 0 mL press or O zero key UJ To accept new value press ENTER e Display returns to normal secondary page after six seconds Resuming an Interrupted Secondary Infusion 1 Follow Start Up steps and select NEW PATIENT no cerns cy NOTE If resuming an infusion on a dual channel instrument oe a T a with an infusion currently running NEW PATIENT screen does not appear
85. may be set by qualified service personnel from 1 mmHg to 600 mmHg Pressure Limit Maximum When a Downstream Occlusion is detected one of the following Occurs e f Auto Restart Plus feature is on instrument notifies clinician with a Checking Line message and audible tone See the following section Auto Restart Plus Feature for further details e f Auto Restart Plus feature is off instrument notifies clinician with an OCCLUSION DOWNSTREAM alarm Resistance and High Resistance Monitoring 44 ADVANCED OPERATIONS Dynamic Monitoring System Continued Monitoring Options Resistance Mode Continued Auto Restart Plus Feature The Auto Restart Plus feature provides the ability to automatically continue an infusion if downstream resistance or pressure measurements indicate that an occlusion condition has cleared within a 40 second Checking Line period excluding High Resistance Monitoring Mode The Checking Line message and tone are presented when a resistance measurement exceeds the alarm threshold of 100 If resistance measurements initiate the Checking Line condition the channel will continue 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 will resume normal operating conditions automatically excluding High Resistance Monitoring Mode P
86. n Ensure air in line sensors are thoroughly cleaned Refer to Cleaning section in this document for further instructions Press continue soft key to allow infusion to continue An alarm occurs if air detector detects an air bubble larger than configured threshold Verity 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 Refer to Cleaning section in this document for further instructions 30 BASIC SYSTEM OPERATION Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY AIR IN LINE Q Alarm hold soft key active AIR IN LINE Q Alarm reset soft key active BATTERY DEPLETED Plug In Q Alarm Battery Low Alert Both A amp B Not Running Prompt Dual channel instrument only Air detector has detected an air bubble larger than configured threshold tolerance Air in Line Reset feature Is oft Air detector has detected an air bubble larger than configured threshold tolerance Air in Line Reset feature Is Ol on Battery is too low to operate instrument Battery has 30 minutes or less of charge remaining was pressed but both channels are not infusing Press hold soft key Open latch to remove set Clear air per hospital protocol Reinstall set Press to resume infusion At flow rates of 1 0 mL h and below verity upstream flui
87. n insert spike into solution container 2 Open AccuSlide Flow Regulator clamp and prime set Pay particular attention to ensure all air is expelled trom set Close AccuSlide Flow Regulator clamp Connect output of set to one side of three way stopcock Load set into instrument Close latch Verity there is no fluid flow or drops falling in drip chamber Plug instrument into a properly grounded AC outlet Set stopcock to output Into a class A or B burette Press to turn channel on 10 Set primary infusion rate to 400 mL h 11 Set VTBI to 20 mL SS Se 12 Ensure instrument both channels if dual channel is set to Pressure mode NOTE The factory default for the Monitoring Options mode is Pressure 13 Press to start primary infusion Infuse until tubing and burette are fully primed approximately one minute 14 Press to stop infusion 15 Adjust height of instrument and or fluid container to attain a head height of 30 1 inches 76 2 2 5 centimeters between middle of pumping mechanism and fluid level in NOTE A 30 head height was used in the initial qualification of this process and is the recommended head height for the Check In Rate Accuracy Test Based on observed field use a 24 head height was also tested and verified for the Rate Accuracy Specification e bag or vented bottle vent closed on administration set or e drip chamber unvented bottle with vent open on administration set 1
88. nel MAINTENANCE 105 lt gt 2 m Z gt Z A m Unpacking 1 Remove instrument from its carton 2 Important Plug instrument into an AC outlet a minimum ot 24 hours prior to use e Maximum battery capacity as well as gauge accuracy Is reached after several charge discharge recharge cycles in the refresh process ALARIS Medical Systems recommends that the battery be fully charged discharged recharged using the refresh cycle before placing the instrument in use 3 Perform Periodic Inspections as indicated in Inspection Requirements section of this document Failure to properly charge the battery will result in an instrument malfunction See the Configurable Options section of this document for a list of the configurable features Complete programming instructions are in the Technical Service Manual Check In and Configuration This is a quick reference procedure for check in and configuration of new and recently serviced instruments The Charge the battery for a minimum of following check in and configuration procedures are taken from 24 hours prior to performing the the current service manual and service bulletins following check in and configuration procedures Batteries without a full charge on initial use may become damaged and or cause a malfunction e Rate Accuracy Qualifi
89. nish Press stop timer soft program key to make changes Time Out of Range Programmed step time exceeds Verity and reenter settings Prompt 24 hours and 59 minutes or is less than one minute Timer Running or was pressed while Wait several seconds for popup Prompt timer was running in Multi Dose to finish Press stop timer soft program key to make changes VTBI O 7130 7230 VTBI has counted down to zero Put channel on hold to reenter a Alert Channel is in KVO mode primary VTBI Change solution container If necessary OR Terminate infusion BASIC SYSTEM OPERATION 39 THIS PAGE INTENTIONALLY LEFT BLANK 40 BASIC SYSTEM OPERATION PAN DVN Git DO H YATO NOTE All features and options are shown enabled in this section The optional features illustrated may not have been enabled on the instrument Dynamic Monitoring System The Dynamic Monitoring System provides the clinician 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 e Monitoring Options to select IV line site monitoring modes of resistance high resistance and adjustable or fixed pressure e Auto Restart Plus Feature allows instrument to automatically resume operation when specific instrument operating conditions are met
90. nitial 20 40 60 80 100 120 Time min Resistance Mode Trumpet Curve at 999 9 mL h initial 15 oa oO 1 o Ls oO uct oO 5 5 10 15 20 25 30 Observation Interval min Resistance Mode Trumpet Curve at 999 9 mL h 24 hr 10 15 20 25 30 Observation Interval min Legend mM Maximum rate error m Overall rate error Minimum rate error APPENDIX 123 gt z ag a Z z x Trumpet and Start Up Curves Continued High Resistance Mode High Resistance Mode Start up at 999 9 mL h initial 0 20 40 60 80 100 120 Time min High Resistance Mode Trumpet Curve at 999 9 mL h initial Flow Rate Error 3 ro on 3 D R oO 0 5 10 19 20 25 30 Observation Interval min High Resistance Mode Trumpet Curve at 999 9 mL h 24 hr o oa 1 o Flow Rate Error O EN oO a oO 0 5 10 15 20 25 30 Observation Interval min Legend E Maximum rate error Overall rate error Minimum rate error 124 APPENDIX ALARIS MEDICAL SYSTEMS ALARIS Medical Systems Inc 10221 Wateridge Circle San Diego California 92121 U S A Mail P O Box 85335 San Diego California 92186 5335 U S A Authorized EU Representative ALARIS Medical UK Ltd The Crescent Jays Close Basingstoke Hampshire RG22 4BS UK ALARIS Medical Systems AccuSlide Dynamic Monitoring Guardrails Signature Edition
91. nually Setting Pressure Baseline While Operating in Adjustable Pressure Mode Continued 5 Press ok soft key 6 Verify pressure readout is zero 0 mmHg NOTE 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 7 To start infusion press EH NOTES e The pressure baseline calibration will remain in effect until the instrument is turned off the latch is opened the set is reloaded or the set Pressure Baseline function is performed again e Setting the manual baseline overrides the auto baseline until the instrument is turned off the latch is opened set is loaded or another manual baseline is set e 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 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 Qualified service personnel can turn this feature off or on Downstream Occlusions which occur in Pressure or Resistance modes are indicated by a tick mark f at the top of the trend screen ADVANCED OPERATIONS 53 SNOILVYs4dO G
92. nue soft key to temporarily bypass reminder Verify and reenter settings Channel must be on hold to change modes Channel will automatically switch to KVO infusion Channel must be on hold to change modes 34 BASIC SYSTEM OPERATION Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY New Baseline Set A new Manual Pressure Baseline Baseline will remain set until a Prompt has successfully been set new manual baseline is set instrument is turned off or latch Manual Pressure Baseline has been opened feature is on No Numeric Entries A numeric key was pressed Wait several seconds for popup Prompt during nonnumeric selection to finish Press ok soft key to approve all displayed information OR Press VAN soft key to view available unit selections gt GH AL a EY alr St lt NO UPSTREAM FLOW Flow has been obstructed Check to see if container is DETECTED between container and empty flow sensor is B Alarm instrument when using a flow mispositioned or clouded tubing Sensor is kinked or air vent Is closed Verity correct 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 flo
93. ode at rates of 1 0 mL h or above is recommended NOTE Tests conducted in accordance with IEC 60601 2 24 Particular requirements for safety of infusion pumps and controllers and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers using a Model 72003 Administration Set includes AccuSlide Flow Regulator APPENDIX 119 gt V E m TA z gt x lt Trumpet and Start Up Curves Continued Pressure Mode 0 20 0 18 0 16 0 14 Pressure Mode Start up at 0 1 mL h initial 0 12 0 10 ATTAT mL h hal 0 04 0 02 0 00 0 02 0 20 40 60 80 100 120 Time min Pressure Mode Trumpet Curve at 0 1 mL h initial 100 oO O O 20 0 5 10 15 20 25 30 Observation Interval min Pressure Mode Trumpet Curve at 0 1 mL h 48 hr _ gt Deo O O O O Flow Rate Error O 0 5 10 15 20 25 30 Observation Interval min NOTE The plot range has been increased to 100 to allow visualization of the graph Pressure Mode Start up at 1 mL h initial E E 0 20 40 60 80 100 120 Time min Pressure Mode Trumpet Curve at 1 mL h initial 3 5 uw g O X z LL 0 5 10 15 20 25 30 Observation Interval min Pressure Mode Trumpet Curve at 1 mL h 48 hr n Sz o 1 gl Flow Rate Error oO as Oo an oO 0 5 10 15 20 25 30
94. ontainer The primary medication prior to the start of a VTBI and VI include the Loading Dose volumes When the continuous infusion or delivering fluid Loading Dose VTBI reaches zero a transition tone will sound challenges This feature is for delivery if the transition tone feature Is enabled Load Dose Complete from primary containers only Using message will be displayed for a few seconds and the primary this feature with two separate settings will automatically take effect containers may result in unintended flow rates U m S mn Z U GADNVACV SP Qualified service personnel can turn the Loading Dose feature on or off NOTE Verify the primary mode parameters prior to accessing the Loading Dose option Entering a New Program Select the desired channel as necessary The channel must be on hold in the primary or secondary mode 1 Press oPtions e Options page appears ADVANCED OPERATIONS 87 Loading Dose Continued Entering a New Program Continued 2 To view additional selections press page soft key 3 Press Loading Dose soft key e Loading Dose infusion rate is highlighted 4 If current value is appropriate press ENTER OR To enter a new infusion rate use numeric keypad and press co e Loading Dose VTBI is highlighted 5 If current value is appropriate press ENTER OR To enter a new VTBI use numeric keypad and press EN
95. place the channel on hold and then proceed Verity primary settings are appropriate Press sec CAUTION e Secondary setup page appears Do not access the secondary key until e Secondary infusion rate is highlighted first confirming the primary program gt lt a ena EY alr St lt If current secondary infusion rate is appropriate press ENTER OR To enter a new infusion rate use numeric keypad Press co e Secondary VTBI is highlighted NOTE The maximum rate for a secondary infusion is 270 mL h If current secondary VTBI is appropriate press ENTER OR To enter a new VTBI use numeric keypad Press ENTER To start secondary infusion press channel s La e Channel s infusing indicators light e When secondary infusion is complete instrument automatically switches to primary infusion parameters BASIC SYSTEM OPERATION 23 Secondary Infusion Continued Making Changes During Secondary Infusion Select the desired channel as necessary The channel does not need to be on hold to change the settings for Rate or VTBI 1 Press soft key next to parameter to be edited Changing Secondary Infusion Rate e Current value is highlighted 2 To enter a new value use numeric keypad 3 To accept press ENTER Viewing or Changing Primary Settings During Secondary Infusion Select desired channel as necessary 1 Press Pri
96. play continues to show programmed infusion rate e KVO flashes in infusion status bar e KVO alert tone sounds Press audio volume key to adjust e VTBI 0 7130 7230 or INFUSION IN KVO 7131 7231 message flashes and alert tone continues until channel is placed on hold Resuming Primary Operation from KVO Select the desired channel as necessary 1 To place channel on hold press channel s La 2 Press VTBI soft key e Primary VTBI is highlighted 3 To enter a new VTBI use numeric keypad BASIC SYSTEM OPERATION 21 KVO Mode Continued Resuming Primary Operation from KVO Continued 4 To accept new value press ENTER 5 To resume primary infusion press channel s La Secondary Infusion This mode is designed to support automatic secondary infusions WARNING piggybacking in the same instrument channel When the e Secondary applications require the secondary VTBI reaches zero a transition tone will sound if use of a check valve set on the the transition tone feature is enabled Secondary Complete primary IV line message will be displayed for a few seconds and the primary settings will automatically take effect Both channels of a dual channel instrument can be programmed for primary and secondary operation e The secondary solution container must be higher than the primary solution container e The secondary VTBI settings
97. ram Continued Changing Weight or Height Continued 3 To highlight weight value press Wt soft key once To highlight Ht press Wt soft key twice or press Wt soft key and then enter 4 To enter new value use numeric keypad Press ENTER e Recalculated volumetric rate is displayed 5 To approve all displayed information and advance to main hold page press ok soft key 6 To resume infusion press or run soft key Changing Concentration NOTE Any change to the drug amount or diluent volume recalculates the volumetric rate to maintain dose rate 1 To place channel on hold press La 2 To return to setup page press setup soft key 68 ADVANCED OPERATIONS Drug Specific Dose Rate Calculator DRC Continued Making Changes During DRC Program Continued Changing Concentration Continued 3 To select concentration value press Conc soft key once To highlight diluent value press Conc soft key twice or press Conc soft key and then ENTER 4 To enter new value use numeric keypad Press ENTER e Recalculated volumetric rate is displayed 5 To approve all displayed information and advance to main hold page press ok soft key 6 To resume infusion press or run soft key ADVANCED OPERATIONS 69 SNOILVYsAdO GADNVACV Resuming an Interrupted DRC Program The channel will retain its place in the program if the instrument i
98. ration mcg mg gm Un mUn or mEg Weight kg or Ib Height cm or inches 5 To approve all displayed information and advance to first setup page press ok soft key e To calculate volumetric rate proceed to Calculating Volumetric Rate section e To calculate dose rate proceed to Calculating Dose Rate section Programming DRC When a Drug Name is Not Listed 1 In alphabetic preselection menu press soft key next to T Z AB selection w Select Drug A et eer 2 To use generic dose calculation feature press Drug soft lorrroys key A e Dose concentration and weight units are displayed e First segment is highlighted To approve all displayed information and advance to first setup page press ok soft key at any time ADVANCED OPERATIONS 59 SNOILVYsdO GADNVACV Drug Specific Dose Rate Calculator DRC Continued Entering a New Program Continued Programming DRC When a Drug Name is Not Listed Continued 3 If dose unit is appropriate press ENTER OR To scroll through units available press and release BN soft key When correct unit is displayed press ENTER Repeat this step for other two dose unit segments e Concentration unit is highlighted Dose Units NOTES mcg mg gm nan MUn Un or MEW kg m2 or e f is selected for the weight units the weight field min h or day
99. ressure 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 is stopped until manually restarted Qualified service personnel can turn off this feature or program from one to nine Checking Line restarts After the programmed number of restarts has occurred or the 40 second Checking Line period has been exceeded the channel will immediately alarm OCCLUSION DOWNSTREAM when resistance or pressure conditions indicate an occlusion The programmed number of restarts become available again when or the soft key labeled run is pressed 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 NOTE To optimize the alert feature it is advisable to set the alert level 20 30 higher than the initial displayed resistance Read the resistance approximately two minutes after starting an infusion Qualified service personnel can turn this Alert feature on or off and set a power on default alert level ADVANCED OPERATIONS 45 v m S mm v GADNVACV Dynamic Monitoring System Continued Resistance Alert Continued Setting Alert Marker To numerical
100. rument some messages will also display Channel A or Channel B to s ba indicate which channel is affected Always verify the A B ml hr ml hr KVO OPT HLD PRI SEC PRI SEC HLD OPT KVO AlB 5 OPTIONS A N Rate 125 0 mL h 1 VTBI 1000 0 mL channel is selected before making any changes F VI 0 0mL Channel A Resistance Alert LA 2 5 E F 0 Hcr ao o _ aa BASIC SYSTEM OPERATION 29 Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY ACCUMULATED AIR IN LINE Q Alarm hold soft key active ACCUMULATED AIR IN LINE Q Alarm reset soft key active Air In Line Prompt Air detector has detected multiple small bubbles Air in Line Reset feature Is O off Air detector has detected multiple small bubbles Air in Line Reset feature Is O on Air detector has detected air prior to starting infusion or is in poor contact with set Press hold soft key Open latch to remove set Clear air per hospital protocol Reinstall set Press to resume infusion Ensure air in line sensors are thoroughly cleaned Refer to Cleaning section in this document for further instructions Evaluate air in set Remove air It air bubbles are clinically insignificant press reset soft key and then press run soft key to resume infusio
101. s trom the date of delivery by ALARIS Medical Systems to the original purchaser B The battery and each new accessory are free from defects in material and workmanship under normal use and service for a period of ninety 90 days trom the date of delivery by ALARIS Medical Systems to the original purchaser If any product requires service during the applicable warranty period the purchaser should communicate directly with ALARIS Medical Systems headquarters San Diego CA to determine the appropriate repair facility Except as provided otherwise in this warranty repair or replacement will be carried out at ALARIS Medical Systems expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to the repair facility shall be at purchaser s risk In no event shall ALARIS Medical Systems be liable for any incidental indirect or consequential damages in connection with the purchase or use of any ALARIS Medical Systems product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and ALARIS Medical Systems shall not be responsible for any loss or damage arising in connection with the purchase or use of any ALARIS Medical Systems product which has been a a b repaired by anyone other than an authorized ALARIS Medic
102. s turned off 1 Follow Start Up Sequence steps and select NEW PATIENT no NOTE If resuming an infusion on a dual channel instrument with an infusion currently running NEW PATIENT screen does not appear e Return To Dose Rate page appears 2 Press yes soft key e Pressing no soft key returns screen to primary setup page Verity settings prior to resuming an infusion 3 To access setup parameters press Review Resume soft key 4 To verify drug being infused and advance through Dose Rate setup pages press ok soft key 5 Verity all settings are correct If a change is required refer to Making Changes During DRC Program section 6 To resume infusion press or run soft key 70 ADVANCED OPERATIONS Drug Specific Dose Rate Calculator DRC Continued The channel must be on hold 1 Press menu soft key Drug Specific Dose Rate Calculator DRC Continued Quitting DRC Program 2 To return to primary setup page press Quit Program soft key Multi Step Program This feature allows a sequential drug delivery program up to nine steps to be set delivering volumes of fluid at different rates during each step This allows the clinician to set up the instrument parameters once and deliver a step profile eliminating the need to change the rate and VTBI after each step of the infusion The infusion may be programmed in
103. soft key 2 Remove air per hospital protocol NOTE Opening the latch or turning the channel off will clear air memory 3 To resume infusion reinstall set and then press Lay Single or Accumulated Air Bubble Detection Reset Feature Available If air volume is clinically insignificant press reset soft key or a key followed by run soft key or key to resume infusion e Subsequent air bubbles trigger alarm 28 BASIC SYSTEM OPERATION Alarms Alerts and Prompts There are three types of displayed messages The messages are listed alphabetically 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 or hospital procedure f Rate 130 5 mL h VTBI 1000 0 mL VI 0 0 mL _ Resistance Alert ALARM instrument or channel problem e infusion stops e icon illuminates alarm tone sounds e rate LED display flashes e message appears in Main LCD Display ALERT may indicate a change in infusion status gt Sa ay EY alr St lt e channel continues to operate e alert tone sounds e message appears in Main LCD Display PROMPT infusion status not changed Start up procedures were not completed or an invalid key was pressed Selected Channel NOTE When using the dual channel inst
104. splay s Indicates current infusion rate s in mL h Flashes to indicate hold or alarm condition and when in KVO mode Model 7130 7131 Status Bar Indicates which mode the Instrument Is in Optional Modes Primary Hold Secondary or KVO Model 7230 7131 Status Bars Indicate which mode each channel is in KVO Optional Modes Hold Primary or Secondary Lower Display The lower LCD display is backlit for easy viewing The display dims when operating on battery power as an energy saving feature Panel Lock Indicator Displayed if panel lock is on Audio Volume Indicator amp Indicates audio volume for alarms and alerts O e Ar a 4omy O Displayed if instrument is in computer monitor mode Instrument ID Label GOTA Ll Characters are entered by qualified service personnel to Peppo identify configuration ownership location etc A Battery Power Gauge Indicates approximate battery time remaining under current infusing conditions SP SP NOTES e The instrument label and battery gauge are always displayed even when the instrument Is turned off however the battery gauge does not represent the battery time remaining when the instrument Is turned off e To ensure a more accurate battery gauge reading review the battery gauge five minutes after starting an infusion The gauge updates for each program change while
105. srupted Computer Link feature is in monitor mode A dose delivery has just been completed Multi Dose Alert feature is Oj on Calculated dose is outside allowable range Turn channel off and then on If problem persists do not use channel Contact qualified service personnel Channel must be turned on to view or change settings Auto Restart Plus Feature must be on for downstream occlusion alerts not required tor upstream occlusion alerts Check administration set for probable cause kinked tubing clogged filter etc Press to confirm entry or press twice to return to previous settings NOTE Channel will operate as previously programmed until is pressed Complete setup Press ok soft key Check RS 232 connections Clearing this alarm automatically puts instrument in monitor mode Reestablish infusion Channel will automatically switch to timer X If Dose Complete Alert Option is activated press cancel alert soft key to silence audio signal Verify and reenter settings 32 BASIC SYSTEM OPERATION Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY Dose Rate Running Prompt Entry Invalid Prompt FLOW SENSOR UNPLUGGED Q Alarm HOLD TIME EXCEEDED Q Alarm INFUSION IN KVO 7131 7231 Alert INSTRUMENT MALFUNCTION Q Alarm Instrument Self Check Is Due Please Eject the Set Prompt Invalid Entry Rate Out of Range Prompt KEY STUCK Q A
106. t North America For technical information related to maintenance procedures and service manual support United States Canada Phone Phone Toll free 858 458 6003 Eastern 800 908 9918 Toll free 800 854 7128 Ext 6003 Western 800 908 9919 For more detailed information refer to the Service Information section of this document Technical Support and Customer Service UK For technical and service information Customer Service Technical Support Freephone 0800 917 8776 Freephone 0800 389 6972 Fax 01256 330 860 For more detailed information refer to the Service Information section of this document About the Instrument INTRODUCTION bout the Instrument The Signature Edition GOLD Infusion Pump includes Model 7130 7131 and Model 7230 7231 Infusion Pumps with Resistance Monitoring Mode Adjustable Pressure Capability and AccuSlide Flow Regulator administration sets Z JJ J N Z e The single channel Model 7130 7131 provides a full range of features in a small easy to use linear peristaltic pump e The dual channel Model 7230 7231 offers the same features while providing two independent infusion pumps in one instrument ALARIS Medical Systems Infusion Pumps are intended for use in today s growing professional healthcare environment including healthcare facilities home care and medical transport that utilize infusion pumps for the delivery of flu
107. t remain on constantly when the device Is powered on may indicate improper functioning of the Main LCD Display Although the instrument is functioning properly return the instrument to qualified service personnel Z JJ J C N z Z Channel Indicator dual channel only Indicates which channel is currently selected Highlight Indicates value is selected Values must be highlighted to be changed A flashing highlight indicates entry is incomplete Complete entry and press enteR or clear existing value enter desired value and press ENTER Soft Keys The keys on the side and bottom of the Main LCD Display serve a variety of functions What each key does is indicated by the text in the display at the time Active Soft Keys Indicated by a TICK M mark next to the key A X OPTIONS 1 Press an active key to highlight desired area in display 2 Enter a value using numeric keypad 3 Press to accept highlighted value Inactive Soft Keys Indicated by having no TICK W mark at the left and bottom edges of the display Split Screen dual channel only When both channels are infusing the split screen showing programmed information is displayed after one minute Pressing shows the split screen immediately INTRODUCTION 5 Displays Continued Rate Display s The LED rate display is easily viewed from a distance Rate Di
108. ted volume and test results were e inside a range of 5 5 to 7 0 from expected volume perform rate calibration per Preventive Maintenance section of Service Bulletin 490 or most current version Set rate calibration number to 0 0 before running rate test to determine a new calibration number Continued on Next Page MAINTENANCE 109 lt gt 2 mi Z gt Z A mi Check In and Configuration Continued Rate Accuracy Qualification Test Continued e outside a range of 5 5 to 7 0 from expected volume return instrument to ALARIS Medical Systems for repair or replace mechanism 27 Set stopcock to drain fluid in burette to zero level in preparation for next test Set Sensor Check Pressure Calibration Verification Access DIAGNOSTICS MODE by pressing and holding upper left soft key on power up Reference Troubleshooting chapter of service manual for details or contact ALARIS Medical Systems Technical Support see Service Information in this document NOTE XX XX in the illustrated display represents the current software revision Advance to D6 page and choose Cal Pressure both Channel A and Channel B for dual channel instruments Verity both 0 mmHg and 500 mmHg readings indicate Pass Install a standard set and close latch Verify reading is over 170 to confirm set sensor operation Remove standard set and verity Sensor reading is in 80 to
109. the dose rate e All drug names are generic Dual channel instrument only Drug names longer than ten letters scroll when displayed on the split screen e The Drug selection can be used for calculating when a particular drug name Is not available on the drug list e When a drug amount is greater than 10 000 units Un a K Is used to indicate a value multiplied by 1 000 for example 1 000 000 1 000k e DRC cannot be used in conjunction with secondary or other operating modes Entering a New Program Select the desired channel as necessary The channel must be infusing in the primary mode or on hold in the primary mode secondary mode or a Loading Dose program 1 Press oPtions e Options page appears Drug Specific Dose Rate Calculator DRC Continued WARNING D Ensure the correct entry of all drug calculation infusion parameters References in this document to specific drugs and drug doses are for example only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages 2 Press Dose Rate Calculator soft key NOTE For instruments with European selected as the Regional Setting proceed to step 3 of Programming DRC When a Drug Name is Not Listed section e DOSE RATE MENU appears SP 3 Press Enter New Program soft key e An alphabetic preselection menu is displayed ADVANCED OPERATIONS 5 7 ae
110. to Alarm Bolus Volume Environmental Conditions Atmospheric Pressure Relative Humidity Temperature Range Serial numbers above 3682241 Temperature Range Serial numbers below 3682242 Flow Rate Range Specifications Continued NOTE Time to Occlusion and Bolus Volume data tested to standards defined in AAMI ID26 1998 Section 51 101 b Time to Detect Monitoring Options Downstream Occlusion Pressure Resistance and minutes High Resistance 25 600 100 100 Threshold Settings mmHg mmHg 25 mmHg 600 mmHg eal Maximum 2 75 2 7 m Typical 0 6 30 0 6 4 Maximum 1 29 1 3 2 h ag Typical 0 1 1 0 1 1 When the occlusion alarm pressure limit is set to the maximum threshold setting the maximum infusion pressure generated into a hard occlusion at 25 mLyh is 11 6 3 9 psi Bolus Volume Released Upon Correcting Monitoring Options Pressure Resistance and Downstream Occlusion Hioh Resi mL Ign Resistance 25 600 100 100 TEE E EEG mmHg mmHg 25 mmHg 600 mmHg Maximum 0 5 0 5 0 5 0 5 1 ml h Typical lt 0 1 0 3 lt 0 1 lt 0 1 25 muh enue 0 5 0 5 0 5 0 5 Typical lt 0 1 0 3 lt 0 1 0 3 Testing performed using IV set model 72003 at 68 8 F 20 4 C Operating 700 to 1060 hPa 20 to 90 Noncondensing 41 to 104 F 5 to 40 C 50 to 104 F 10 to 40 C Storage 500 to 1060 hPa 5 to 95 Noncondensing
111. tuations in rate accuracy The following graphs show typical performance of the system for both Pressure and Resistance Modes in two ways 1 the accuracy during various time periods over which fluid delivery is measured trumpet curves and 2 the 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
112. ument and present the Checking Line message for ten seconds to confirm or rule out the presence of an occlusion If the occlusion condition is determined not to exist flow will resume and no alarm is produced Drug Specific Dose Rate Calculator DRC This feature allows the clinician to select a drug name to CAUTION calculate a volumetric rate or a dose rate for continuous drug infusions and is based on parameters such as drug dosage patient weight concentration etc Once calculated the instrument displays the drug name selected on the infusion screen Generic calculation Drug is provided for drugs not available on the drug list or when European is selected as the Regional Setting When the DRC VTBI has counted down to 0 0 mL the channel will switch to the preset KVO rate or remain at the current rate whichever is less Instruments with European selected as the Regional Setting do not have a drug list When Dose Rate Calculator is chosen from OPTIONS menu followed by Enter New Program the instrument goes directly to the generic dose rate calculation SP Qualified service personnel can turn the Dose Rate Calculator feature on or off 56 ADVANCED OPERATIONS Facts About DRC e The patient weight drug concentration and diluent volume cannot be changed while infusing Changes to any of these items while on hold will recalculate the volumetric rate to maintain
113. ure bar graph is not shown when the split screen display is active e For optimal results set the baseline 15 minutes after starting an infusion The pressure baseline can be optimized particularly at low flow rates less than 3 mL h by resetting the pressure baseline when the readings are negative Check periodically for negative readings for example when programming VTBI This allows the pressure baseline to calibrate based on current system pressure ADVANCED OPERATIONS 51 Dynamic Monitoring System Continued Pressure Baseline Continued Manually Setting Pressure Baseline While Operating in Adjustable Pressure Mode Continued 1 To place channel on hold press channel s key All infusions connected to the channel being base lined must be on hold 2 Press otions e Options screen appears 3 Press Set Pressure Baseline soft key e Set Pressure Baseline screen appears NOTE To return to the normal screen without setting the baseline press return soft key 4 Verify no pressure due to occlusion or other infusions through a common line is present in IV line at this time NOTE For best results verify the outlet of the set for example stopcock is located at the patient s heart level before continuing with the next step pressing ok soft key to perform baseline 52 ADVANCED OPERATIONS Dynamic Monitoring System Continued Pressure Baseline Continued Ma
114. ver a period of up to 24 hours This feature also offers a delayed start option up to 8 hours and a Dose Complete Alert Option to alert the clinician of the completion of each dose delivered 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 Qualified service personnel can turn the Multi Dose and Dose Complete Alert Option features on or off 80 ADVANCED OPERATIONS Multi Dose Program Continued Entering a New Program Select the desired channel as necessary The channel must be on hold in the primary mode secondary mode or a Loading Dose program 1 Press oPtions e Options page appears 2 To view additional selections press page soft key 3 Press Multi Dose soft key e MULTI DOSE MENU page appears 4 Press Enter New Program soft key e Setup page appears e Infusion rate is highlighted ADVANCED OPERATIONS 81 SNOILVYsAdO GADNVACV Multi Dose Program Continued Entering a New Program Continued 5 To enter infusion rate use numeric keypad Press ENTER e VTBI Dose volume to be infused per dose is highlighted 6 To enter VTBI Dose use numeric keypad Press ENTER e Number of doses to be given is highlighted 7 To enter number of doses use numeric keypad Press ENTER e Dose frequency is highlighted 8
115. w sensor from the instrument OCCLUSION DOWNSTREAM Pressure In IV line has exceeded a Check administration set for B Alarm pressure alarm threshold probable cause kinked tubing OR closed stopcock high resistance catheter etc Press run soft key Resistance has reached 100 to restart infusion Occlusion Downstream A very high pressure exists in Remove source of high pressure Prompt fluid line while baseline is being and repeat setting of pressure set baseline Pressure Baseline feature Is O on BASIC SYSTEM OPERATION 35 Alarms Alerts and Prompts Continued MESSAGE PROBABLE CAUSE REMEDY OCCLUSION UPSTREAM Q Alarm Ok Entry Prompt Panel Locked Prompt Place on Hold to Change Prompt Place on Hold to Set Pressure Baseline Prompt Press and Hold Key to Turn Off Prompt Pressure Limit XXX mmHg Prompt NOTE XXX represents the configured maximum pressure Pressure Limit Must Be Less Than or Equal to XXX mmHg Prompt NOTE XXX represents the configured maximum pressure Flow has been obstructed between fluid container and instrument User has attempted to go to another page before pressing ok soft key A key was pressed Panel lock feature Is on A key was pressed during KVO SET PRESSURE BASELINE function has been selected while running Pressure Baseline feature Is Ol on was pressed An elevated pressure was present in fluid path when pressure baseline was est
116. w sensor to instrument handle when not in use NOTES CAUTION e The flow sensor should be routinely cleaned with warm water Do not use solvents or cleaning while actuating the slider then dried thoroughly agents Damage to plastic parts of e See the Radio Frequency Interference information in the the flow sensor could occur Warnings and Cautions User Precautions section CAUTION 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 tlow sensor In this event unplug the flow sensor trom the instrument RS 232 Computer Link The optional Computer Link feature allows a hospital computer GZ to interact with the instrument The computer cannot start or Use of accessories or cables other stop the instrument set the rate or make any change in status than those specified may result in If the feature is off the computer cannot communicate with the degraded electromagnetic instrument If the feature is Monitor the computer can only compatibility performance of this receive information from the instrument device NOTE To assure continued electromagnetic compatibility performance the communications cable attached to the instrument should be no longer than one meter have fully shielded connector housings and hav
117. y NO To enter new value use numeric keypad Press ENTER e New recalculated value takes effect as soon as is pressed NOTE TTTTT or WW appears in the dose field if rate titration causes the calculated dose value to be outside the display s range Recheck the entered parameters Changing VTBI 1 To highlight value press VTBI soft key 66 ADVANCED OPERATIONS Drug Specific Dose Rate Calculator DRC Continued Making Changes During DRC Program Continued Changing VTBI Continued 2 To enter new value use numeric keypad VI temporarily disappears Press ENTER NOTE If the flow sensor option is being used Dose Rate VTBI can be turned off by selecting VTBI and then pressing co OR Dose Rate VTBI can be deleted from VTBI VI screen and main hold page Configurable Options Clearing VI 1 To move highlight to VI press VTBI soft key twice OR Press VTBI soft key and then press ENTER SNOILVYs4dO GADNVACV 2 Press or 0 zero key e VTBI temporarily disappears and VI is highlighted Press ENTER Changing Weight or Height NOTE Any change to the weight or height recalculates the volumetric rate to maintain dose rate 1 To place channel on hold press a 2 To return to setup page press setup soft key ADVANCED OPERATIONS 6 7 Drug Specific Dose Rate Calculator DRC Continued Making Changes During DRC Prog
118. y SmartSite Valve may be accessed by a needle and will leak if punctured To access port with needle without causing leakage attach a PRN adapter of sufficient length to SmartSite Needle Free Valve Port Artifacts It is normal for infusion devices to produce nonhazardous currents when infusing electrolytes These currents vary in proportion to the infusion device flow rate When the ECG monitoring system is not functioning under optimal conditions these currents may appear as artifacts simulating actual ECG readings To determine If ECG abnormalities are caused by patient condition or the ECG equipment place the infusion device on hold If the ECG readings become normal the ECG equipment requires attention Proper setup of the ECG equipment should eliminate these artifacts Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance Contraindications None known 14 BASIC SYSTEM OPERATION Warnings and Cautions Continued User Precautions Continued Dropping Jarring Should an instrument be dropped or severely jarred it should be immediately taken out of service and inspected by qualified service personnel to ensure its proper function prior to reuse Operating Environment lt q DANGER amp Not for use in the presence of flammable anesthetics Explosion risk if used in the presence of flammable anesthetics gt lt a ay EY alr St lt

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