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Alaris Medley Syringe Module 8110 Version 7

1. 2 Press OPTIONS key 3 Press Channel Labels soft key F Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit High Prime Set with Syringe Channel Labels gt Select an Option or EXIT 4 Press soft key for desired label A hene Label Display 0 9 NaCl A E NOTE To view additional labels press a soft key next to a 3 NaCl F J letter group to navigate through alphabet and or PAGE UP CVVHDF Dialysate K O and PAGE DOWN soft keys D5 1 2 NS PT Selected label is highlighted and scrolls in Message oe i Display gt Select Channel Label Al Channel Label Display Peripherial Art Line P Replacement Solution Q Swan R Triple Lumen S gt Select Channel Label ira BACK 5 To continue infusion press START soft key EQ infusion Setup 50 mL h OR 40 mL Program infusion as previously described gt Press START PAUSE ORN 36 PROGRAMMING Syringe Module 8110 Series Direction for Use Channel Labels Continued Removing Channel Label 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Channel Labels soft key F Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit High Prime Set with Syringe Channel Labels gt Select an Option or EXIT 4 Press CLEAR LABEL soft key py c ol Display i i
2. Syringe Module 8110 Series PROGRAMMING 45 Direction for Use Setting Up Drug Calculation Continued Using Non Library Drug Continued 12 Press soft key next to desired DOSING UNITS FEY Drug Calculation G AMOUNT 250 mg DILUENT VOLUME 50 mL Weit TO kg UNS mcg kg min gt gt mg kg min Conc 5000 mcg mL gt Select the Desired Dosing Units DRUG LIBRARY 13 Verify correct drug calculation infusion parameters and FEY Drug Calcutation press NEXT soft key amount 250 mg VOLUME 50 mL FE 70 kg ONE Min urs mcg kg min Conc 5000 mcg mL gt Press NEXT to Confirm eRe NEXT NOTE If the ALL Mode is enabled VTBI ALL displays In Al Drug Calculation the following illustrated examples the ALL Mode is disabled CONTINUOUS INFUSION RAE ___mLh ALL oe mog kg min Conc 5000 mcg mL gt Select RATE or DOSE SETUP BOLUS 14 To make a rate or dose entry press applicable soft key LY Drug Calculation RATE or DOSE and use numeric data entry keys other CONTINUOUS INFUSION value is calculated and displayed RATE ml h EN uu mcg kg min Conc 5000 mcg mL gt Select RATE or DOSE SETUP BOLUS 46 PROGRAMMING Syringe Module 8110 Series Direction for Use Setting Up Drug Calculation Continued Us
3. amuwmnnamwnanamnwanawwnanawnnanuwn 38 Using Guardrails Drug LIDYA II uU RI e a a eques UxPeS Da UE UD EK 39 Using Non Library Drug sssssssssssssssssss RR e eee 43 BOLUS DOSE esae oe PP UTER ey bU EN se dee pe ee Cee enn eee eee es CPU 48 Using Guardrails Drug Library Calculation wmnaasmn 48 Using Non Library Drug Calculation 2 0 0 0 0 00 0 nnn nen nnn enn eee e enn nu 53 Stopping Bol s DOSE AI Ha 54 Restoring Bolus Dose wmnamanmwnnamanawnnawwnawwnawwnaaaanwnaawan 39 ANESHHESIA MODE wi AI WAA 58 Enabling Anesthesia Mode ummmmnnuwwnnnaa ee ees 58 Disabling Anesthesia Mode 2 02 00 0 nee hee 59 DELAY OPTION 61 Delaying IMGUSION oie orne bene SEEREN EDT SEE SED ER REE hares piseqaniacuesequcw ese RESETA 61 Scheduling Callback esteem etm brem bear ret ERE RR Reda et o E ERR Re o du dem pa 65 POUSING JIMMSION MEM E soadedewie 67 MULTIDOSE MODE amaamanmnnmanaawananmwamananamana a ob wahirat iun 68 Programming with Volume Duration Enabled ammama 68 Programming with Volume Duration Disabled
4. wwmmammmmw ees 10 Administration SEIS ii III EA WI 11 OPERATING FEATURES CONTROLS AND INDICATORS wmmamaamaamann na 13 INSTALLATION iii IIIA Ia 14 ATTACHING AND DETACHING MODULES mmnamanwannamaamananmanaaamn 14 US EAST oak case OEA deuevae hago annus si AIKA Aa 14 Main ES Nn 14 Dynamic Pressure Display ii 14 SIA p IA dt gates eee doe EIA 15 Powering On System og cciccce essa eedecnen dered dur rue PEUT optus ndexSqdtretaddiuqhora fredda cid qu Edd add 15 Responding to Maintenance Reminder nannan nannan nnn manana es 15 Selecting New Patient and Profile OptionS mamanwamana 15 Entering Patient D iles ues men Rhone etr e e UR rh rx Y pork ERR RE oto Rp den a ein cogn 15 Modifying Patient AI WA E A EAEE pieri 15 PREPARING INFUSION 4 maux tttm EEEE EEEE D IR EEEE EEEE 15 Administration Set IIIA 15 Preparing Syringe and Administration Set mmnanasnn 16 Loading Syringe and Administration Set 0 00000 nen nnn nee nee nent e ees 16 Selecting Syringe Type and Size wmanamannanawananawwaa 20 PRIMM IA tah td tea eh ea A E REG 22 PROGRAMMING BASIC INFUSION ce 27 Starting Rate Volume Infusion
5. mamama 72 REVIEWING SERIAL NUMBER ii IIIA 75 REVIEWING SOFTWARE VERSION 0 00 eee eee beeen eens 195 ALARMS ERRORS MESSAGES BizgHec4q 77 AUDIO CHARACTERISTICS wA WA 77 FAIS REE SEE AI ewe DO ET C UD TD K 77 Syringe Adjustment AlarMS ii Ai 78 UA ui ES ede teen WE AA UA LA EA Byrn ead ZI EEEE eee 79 ME SADES P 79 MAINTENANCE vigeceuelge v KEDE EER 81 CONFIGURABLE SETTINGS tit trie ER AI PE RR EDU m nU ER red Add RE E 84 System ESI AA KIE IA 84 Shared Infusion Settings Pump Module and Syringe Module 84 Syringe Module Settings IA EA 85 COMPATIBLE SYRINGES orkaner bort Eniri AA IAEA 85 CEEANING os ec AI AAA EEE ERES 86 INSPECTION REQUIREMENTS iii AAA AA R D ITE ERE 86 SERVICE INFORMATION iii HI EK 86 WARRANTY AAA EE IIIA IIIA 87 APPENDIX TRUMPETAND START UP CURVES wai Aa aaa 89 ii TABLE OF CONTENTS Syringe Module 8110 Series Direction for Use INTRODUCTION About the Syringe Module About the Syringe Module The Medley Syringe Module Model 8110 is intended for facilities that utilize infusion pumps for the delivery of fluids medications blood and blood products using continuous or intermittent delivery through clinically acceptabl
6. VOLUME AUDIO INFUSED ADJUST Ifa Before callback has not been scheduled reference Adut iey 09 00 Scheduling a Callback section infusion automatically A VTBI ALL 50 mL initiates at end of delay period VOLUME AUDIO INFUSED ADJUST 62 PROGRAMMING Syringe Module 8110 Series Direction for Use Delay Options Continued Delaying Infusion Continued Specifying by Time of Day The Delay until option is used to program an infusion delay FYIVAC 50 mL for a minimum of 1 minute and up to 23 hours 59 minutes 40 mum 1 Press DELAY OPTIONS soft key AGE gt Press START ESSE 2 Press Delay until soft key FY Delay Options os Pause Delay for Delay until LALL DACK BACK gt Select a Delay Option BACK 79 oO G D gt z G 3 If Current time displayed is correct press CONFIRM soft FEY Delayed Options key otherwise press Change Time and enter correct Time of Day time Reference Setting Up Time of Day procedure in Current time Change Medley Point of Care Unit DFU did NOTE If the current time has been previously confirmed the Time of Day screen will not be displayed gt CONFIRM Time of Day 4 To enter time of day infusion is to be initiated up to FA Delay Options 08 00 23 hours 59 minutes use numeric data entry keys Pause
7. 72 PROGRAMMING Syringe Module 8110 Series Direction for Use Multidose Mode Continued Programming with Volume Duration Disabled Continued 5 To enter rate use numeric data entry keys FY multidose 08 00 SS mh gt Enter Rate 6 To enter volume to be infused for each dose press FY multidose 08 00 VOLUME DOSE soft key and use numeric data entry keys 20 muh VOLUME pose mL E U gt Z SES le Q gt Enter Volume Dose x E Z G 7 To enter time interval 1 to 24 hours between doses FY Multidose 08 00 press DOSE INTERVAL soft key and use numeric data MER entry keys 10 mL DOSE every __h gt Enter Dose Interval 8 To enter number of doses press OF DOSES soft key and KY multidose 08 00 use numeric data entry keys 20 muh VERE 10 m If Delay Options is enabled DELAY OPTIONS soft key appears every _ 6h NOTE Reference Delay Options section to program an infusion delay When delaying an infusion a multidose gt Select NUMBER OF cannot be delayed for more than 8 hours and all doses in zie the multidose program must be completed within a 24 hour program Syringe Module 8110 Series PROGRAMMING 73 Direction for Use Multidose Mode Continued Programming with Volume Duration Disabled Continued 9 To begin multidose infusion press START soft key FY Multidose 0
8. z G Syringe Module 8110 Series PROGRAMMING 75 Direction for Use THIS PAGE INTENTIONALLY LEFT BLANK 76 PROGRAMMING Syringe Module 8110 Series Direction for Use ALARMS ERRORS MESSAGES To enhance safety and ease of operation the Medley System provides a full range of audio and visual alarms errors and messages Reference the Medley Point of Care Unit Directions for Use DFU Audio Characteristics Reference the Medley Point of Care Unit DFU Alarms Alarm Meaning Response Channel Disconnected Module s disconnected while in To silence alarm and clear operation or have a communication message from screen press problem CONFIRM soft key Reattach module if desired ensuring it is securely clicked into place at Module Release Latch If alarm is still present replace module with an operational instrument gt Occlusion Increased back pressure sensed Clear occlusion Press RESTART 5 while infusing Infusion stops on key or press CHANNEL SELECT JA affected module key and then START soft key 4 z QW Pressure Disc Installed Pressure sensing disc installed Press CONFIRM soft key and m A during an infusion Infusion stops RESTART key z on affected module o Pressure Disc Removed Pressure sensing disc removed Reinsert pressure sensing disc and Infusion stops on affected module press RESTART key Syringe Empty Syringe is empty gt Set up new infusio
9. mL h ALL gt Select Rate or Restore Previous Infusion VOLUME RESTORE BETA Verify parameters are valid and press START soft key NOTE To change a restored parameter a Press applicable soft key VTBI or RATE b Enter desired parameter using Up Down Arrows for rate titration or numeric data entry keys c Press START soft key FY vac 50 mL 50 mL h ALL gt Press START VOLUME PAUSE VOLUME START Syringe Module 8110 Series Direction for Use PROGRAMMING 31 79 oO G D gt z G Basic Infusion Continued Changing Rate or VTBI During Infusion Press CHANNEL SELECT key Press either RATE or VTBI soft key N PN infusion Setup 50 mL h 40 mL gt Press START PAUSE E START 3 To enter desired parameter use Up Down Arrows for rate titration or numeric data entry keys 4 Verify correct infusion parameter entry and press START soft key Stopping Infusion Press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds and then release to initiate power down NOTES e f no other module is active the system powers down when the CHANNEL OFF key is released To interrupt the power down sequence quickly press any one of the numeric keys on the Point of Care Unit Selecting Pressure Limit Pressure Sensing Disc Installed Ensure pres
10. NOTES e f the Bolus Dose feature is enabled the BOLUS soft key appears in the Continuous Infusion screen and becomes active when a VTBI is entered he bolus VTBI cannot exceed the programmed continuous infusion VTBI e Programming and starting a bolus dose deletes any programmed delay f no continuous rate is entered the infusion will end when the bolus has been delivered No KVO infusion will follow Using Guardrails Drug Library Calculation 1 Setup Drug Calculation as described in Setting Up Drug Calculation Using Guardrails Drug Library section but do not start infusion 2 Press BOLUS soft key Nonweight based example gt Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 mL h 50 mL 9 mg min Conc 20 mg mL gt Press START PAUSE sEruP BoLus START Weight based example gt Guardrails Drug Library Heparin CONTINUOUS INFUSION 5 25 mish 50 mL 15 unit kg h Conc 200 units mL gt Press START PAUSE SETUP BOLUS START Continued on Next Page 48 PROGRAMMING Syringe Module 8110 Series Direction for Use Bolus Dose Continued Using Guardrails Drug Library Calculation Continued e DOSE is highlighted NOTES e f the programmed continuous dose infusion is outside the Guardrails Soft Limit for that care area a prompt appears before programming can continue If t
11. gt Press START to Continue Infusing Bolus Dose STOP PAUSE EOLUE START Stopping Bolus Dose NOTE The display examples in this section represent stopping a bolus dose which was programmed using the Guardrails Drug Library Even where the displays are different when stopping a bolus dose which was programmed using a non library drug the procedure is the same 1 Press CHANNEL SELECT key 54 PROGRAMMING Syringe Module 8110 Series Direction for Use Bolus Dose Continued Stopping Bolus Dose Continued 2 Press STOP BOLUS soft key ATES Drug Library BOLUS DOSE Dose Remaining 5 mg kg Pt Weight 71 kg Time Left 2 min TOTAL DOSE 355 mg BOLUS VTBI 17 8 mL gt Press START to Continue Infusing Bolus Dose PAUSE Sa 3 To stop bolus and start continuous infusion press Yes EX Drug Morar soft key Stop Bolus and Start Yes Continuous infusion No ZU O GQ gt Press Yes or No x Z e 4 To stop continuous infusion press and hold CHANNEL Midtown Hospital OFF key until a beep is heard approximately A VTBI 50mL 1 5 seconds Restoring Bolus Dose A bolus dose can be restored after it has completed either prior to or after the module has been turned off as indicated in the following sections NOTE The display examples in this section represent restoring a bolus dose which was p
12. mammmmanamawnanawamanawwan 28 Starting Volume Duration Infusion manamananaawananawwaa 28 Possible End of Infusion Messages andAlerts 30 Pausind IIMUGION sees eNO EER ESEE EE EREE nee sons IE EPIRI LEPIDE E MEE 30 Restarting Infusion Following Infusion Complete 31 Changing Rate or VTBI During Infusion wmnamananawwnnanawwna 32 SHOPPING IMU OM sere etse merear AAA RISO EIUdUM Eddie sme iE ES 32 Selecting Pressure Limit IAE 32 Viewing and Clearing Volume Infused manamwmanaamananaw wanan 34 Changing Syringe During Infusion iiisssssssssssssssssssss III rs 35 CHANNEL LABELO eere re Phe Rb are se es pate Gee een POR Im breeders eR RIDE KELLER 36 Selecting Channel Label svucoaractoutencutcecsaganeeseweshtedcausder shes cee sie E INESENELIEE HERE DERES 36 Removing Channel Label mmmanamwnanaawwnnaawnanawnnaawawna 37 POWERING OFF ii AAA AI 37 Powering Of System AHAAA 37 Powernng OM aa AA cub rni EEEO EA EERE E EELA auanbeueuraenersennegene 37 Syringe Module 8110 Series TABLE OF CONTENTS Direction for Use PROGRAMMING Continued SETTING UP DRUG CALCULATION wi AA ou wena 38 Drug Calculation Parameters
13. Factory default setting is 1 mL h if set rate is 1 mL h or above or set rate if rate is 0 9 mL h or below KVO Selection Range KVO rate can be set in System Configuration from 0 01 2 5 mL h in 0 01 mL h increments NOTE Flow rates as low as 0 01 mL h are available only with 1cc and 3cc syringes For larger syringes the lower limit adjusts to 0 1 mL h Occlusion Alarm Thresholds Without Pressure Sensing Disc Three settings Low Medium High With Pressure Sensing Disc User selected from 25 to 1000 mmHg in 1 mmHg increments Operating Principle Positive displacement 82 MAINTENANCE Syringe Module 8110 Series Direction for Use Specifications Continued Rate Accuracy Shock Protection Time to Alarm Makimum Volume to be Infused Programming Increments Weight Rate accuracy of the Medley Syringe Module is 2 of full scale plunger travel not including syringe variation GUNN Syringe size and running force variations of back pressure or any combination of these may affect rate accuracy Factors that can influence back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure may also be affected by type of catheter Reference Trumpet and Start Up Curves section in Appendix chapter for data on how these factors influence rate accuracy Type CF Defibrillator Proof Rate mL h No Disc With Disc Highest High
14. G m G T gt A ar m O Press CONFIRM and continue priming gt Press CONFIRM 4 Prime as follows ai Patient Side o a Orient pressure sensing disc with patient side up s b Depress and hold pressure sensing disc between SN 2 fingers Pressure LAS Sensing Disc c Press and hold PRIME soft key until fluid flows and A priming of syringe administration set is complete Prime Set with Syringe CAUTION Do d Release pressure sensing disc d x connected to patient NOTE Fluid is delivered during priming only while the Prime Volume PRIME soft key is pressed Each press of the PRIME soft O mL key delivers up to 2 mL of priming fluid per continuous gt Press and Hold PRIME press To deliver additional amounts press the PRIME soft key again PRIME EXIT e Volume used during priming is displayed but not added to VTBI Syringe Module 8110 Series GETTING STARTED 23 Direction for Use Preparing Infusion Continued Priming Continued Pressure Sensing Disc Used Installed Continued 5 When priming is complete release PRIME soft key A Prime Set with Syringe CAUTION Do deposabeset pied le Prime Volume 2 mL gt Press and Hold PRIME PRIME EXIT 6 Reinstall pressure sensing disc as follows a
15. O a Orient pressure sensing disc as follows e fluid side up patient side down cavity forward membrane toward instrument m Slot in Pressur m Sensing Disc V Fluid Side Housing Pressure y i Sensing Disc gue Patient Side b Gently slide pressure sensing disc up into slot in pressure sensing disc housing c Apply firm upward pressure on pressure sensing disc not tubing until disc snaps into place SEDE Pressure Sensing Disc Syringe Module 8110 Series GETTING STARTED 19 Direction for Use Preparing Infusion Continued Selecting Syringe Type and Size At the start of an infusion program the system prompts to select and confirm the syringe type and size NOTE The system automatically detects the syringe size and lists syringe types and sizes that most closely match the installed syringe If the syringe is not recognized Syringe not recognized displays Use a syringe that is recognized and accepted by the system 1 Press CHANNEL SELECT key WARNING AA Ensure the displayed syringe manufacturer and size correctly identifies the installed syringe Mismatches may cause an under infusion or over infusion to the patient that could result in serious injury and or death For a list of compatible syring
16. Unit None To resume infusion press RESTART key or press CHANNEL SELECT key and then START soft key Press CONFIRM soft key Select and confirm correct syringe type and size and then press CONFIRM or use a syringe type and size that system can automatically and correctly identify 80 ALARMS ERRORS MESSAGES Syringe Module 8110 Series Direction for Use MAINTENANCE The Medley System Technical Service Manual is available from ALARIS Medical Systems It includes routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components Maintenance procedures are intended to be performed only by qualified personnel Specifications Bolus Volume following Occlusion at intermediate rate Pressure Setting Bolus g Without Pressure Sensing Disc Low 0 329 Medium 0 523 High 0 736 With Pressure Sensing Disc Back Off Disabled Back Off Enabled 300 mmHg 0 277 0 098 500 mmHg 0 416 0 136 1000 mmHg 0 764 0 137 The Medley System has a back off safety feature which when enabled and a pressure sensing disc is in use is designed to reduce bolus volume on occlusion release WARNING AAA Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient Critical Volume The maximum over infusion which
17. Volume remaining 7 mL gt Press START Syringe Module 8110 Series Direction for Use PROGRAMMING 71 79 oO Q 79 gt z G Multidose Mode Continued Programming with Volume Duration Enabled Continued Between infusions EXMutidose 08 35 Rate 20 mL n Moumei 10 m Duration 00 n 30 min Yellow Standby Status Indicator illuminates every 06 h x 04 doses Doses completed 1 Dose 2 Starts 14 00 gt Press START PAUSE START Number of doses completed and when next dose starts display Programming with Volume Duration Disabled If Volume Duration was not enabled at the time the Medley System was configured for use use the following procedure to program a multidose infusion 1 Perform steps in Start Up section to a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Perform steps in Preparing Infusion section to a Prepare syringe and administration set b Load syringe and administration set c Select syringe type and size and Basic Infusion as infusion type d Prime 3 Press OPTIONS key 4 Press Multidose soft key PN Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit 550 mmHg Prime Set with Syringe Channel Labels gt Select an Option or EXIT EXIT
18. by sliding flat edge of syringe barrel flange between barrel flange grippers lau E u jp rcu rcu a Syringe Module 8110 Series Direction for Use GETTING STARTED 17 Preparing Infusion Continued Loading Syringe and Administration Set Continued 4 Lock syringe in place a Pull syringe barrel clamp out and hold b Rotate clamp to right clockwise or counter clockwise until it lines up with syringe c Gently release clamp against syringe Syringe Barrel Clamp Closed 5 Lower drive head and lock plunger in place with plunger Gripper Control in grippers Closed Position a Twist gripper control clockwise and hold in position Drive Head Flush NA o NOTE The gripper control is spring loaded When i engen slange laa twisted to the open position and then released it and the plunger grippers will return to the closed position Plunger Grippers Closed b While holding gripper control in open position gently HE pg lower drive head until it makes contact with plunger qo flange ITETIIITI Il Gently release gripper control CAUTIONS d Ensure plunger grippers lo
19. diepossbieset nnected to m yA Prime Volume 2mL gt Press and Hold PRIME PRIME EXIT e f Basic Infusion was selected Infusion Setup screen displays and title alternates between Infusion Setup and identifying syringe model and size e f Guardrails Drug Library was selected Guardrails Drug Library screen displays A Infusion Setup mL h ALL gt Select RATE Guardrails Drug Library Adult ICU Aminophylline 50mg 50mL A E Bretylium 50 mg 25mL F J Dobutamine mg mL K O Dopamine 40mg 50mL P T Dopamine 8mg 25mL U Z gt Select Drug Concentration DRUG PAGE EXIT CALC DOWN 26 GETTING STARTED Syringe Module 8110 Series Direction for Use PROGRAMMING References throughout this chapter to specific drugs and drug doses are for illustration purposes only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages The following procedures should be used only when WARNING programming a Basic Infusion To program an infusion using Whendhenredsuecensno dice ic the Guardrails Drug Library go to the Setting Up Drug bb a g al not being used and an occlusion Calculation section occurs there is a risk of infusing NOTES pressurized buildup of infusates upon correction of the occlusion To The illustrations in this section assume
20. gt Select RATE f Guardrails Drug Library was selected Guardrails Ea coder ong Library Drug Library screen displays Aminophyline 50mg 50mL AE Bretylium 50 mg 25mL F J Dobutamine mg mL K O Dopamine 40mg 50mL P T Dopamine 8mg 25mL U Z gt Select Drug Concentration DRUG PAGE EXIT CALC DOWN Syringe Module 8110 Series GETTING STARTED 21 Direction for Use Preparing Infusion Continued The Priming option can be enabled at the time the Medley System is configured for use The Priming selection PRIME soft key is available only after the syringe and infusion type have been selected and prior to beginning an infusion If a pressure sensing disc is in use it must be removed from instrument before priming Refer to the applicable section as follows depending on whether or not a pressure sensing disc is used NOTE When manually priming per hospital facility protocol and an administration set having a pressure sensing disc is in use depress the disc between 2 fingers while priming and prime uphill distal end of pressure sensing disc tubing pointing upward Pressure Sensing Disc Used Installed 1 Remove pressure sensing disc from instrument e Using a finger apply firm downward pressure on pressure sensing disc not tubing until disc snaps loose from slot in pressure sensing disc housing GUI 1 DU When priming Ensure patient is not connected
21. Delay for gt Enter Delay Time Syringe Module 8110 Series PROGRAMMING 63 Direction for Use Delay Options Continued Delaying Infusion Continued Specifying by Time of Day Continued 5 Press CONFIRM soft key FY Delay Options 08 00 Pause Delay for ZEE oo None gt Select Callback or Press CONFIRM ime infusion is scheduled to start appears on Main Midtown Hospital 08 90 Display A Start at 09 00 VOLUME AUDIO INFUSED ADJUST fa Before callback has not been scheduled AdURICU SP 09 00 reference Scheduling a Callback section infusion A VIBI ALL 50 mL automatically initiates at end of delay period VOLUME AUDIO INFUSED ADJUST 64 PROGRAMMING Syringe Module 8110 Series Direction for Use Delay Options Continued Scheduling a Callback When programming a Delay for or Delay until infusion a callback can be scheduled for that infusion There are 3 types of callback Before gives an alert when delay is completed and infusion needs to be initiated After gives an alert when delayed infusion has completed Before and After gives an alert when delay is completed and infusion needs to be initiated and when delayed infusion has completed The default callback None or the callback for the current profile appears on the Main Display To schedule a different callback WA U 1 Prior to
22. Ensure air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient CAUTION During priming the pressure limit alarms are temporarily increased to their maximum level CAUTION The pressure sensing disc if left installed during priming can trap air that may not be totally expelled To ensure entrapped air is eliminated it is recommended that the pressure sensing disc be removed prior to priming and the membrane massaged with a finger while priming After priming is completed reinstall the pressure sensing disc IC 22 GETTING STARTED Syringe Module 8110 Series Direction for Use Preparing Infusion Continued Priming Continued 2 Press OPTIONS key 3 Press Prime Set with Syringe soft key FY channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit 550 mmHg Prime Set with Syringe Channel Labels gt Select an Option or EXIT EXIT f pressure sensing disc was not removed prior to A pressing Prime Set with Syringe soft key a pressure It is recommended that the sensing disc removal prompt displays Pressure Sensing Disc be removed during priming
23. Features and Definitions Continued Near End of Infusion NEOI Occlusion Pressure Pressure Sensing Disc Pressure Tracking Priming Rapid Bolus Restore Selectable KVO Syringe Empty The NEOI option allows an alert to be configured to sound anywhere from 1 to 60 minutes before the infusion is complete The alert will occur at the configured time or when 25 of the VTBI remains whichever comes later A complete range of downstream occlusion detection options is provided With pressure sensing disc Downstream occlusion alarm threshold is selectable between 25 and 1000 mmHg in 1 mmHg increments e Without pressure sensing disc Downstream occlusion alarm threshold can be set to low medium or high When installed the pressure sensing disc significantly improves the instrument s pressure sensing capabilities for a faster occlusion detection time and makes the following features available Auto Pressure Back Off Customizable Pressure Alarm Settings see Occlusion Pressure Fast Start Pressure Tracking The dynamic current pressure display is only available when the pressure sensing disc is inserted The Priming option allows a limited volume of fluid to be delivered in order to prime the administration set prior to being connected to a patient or after changing a syringe When priming a single continuous press of the PRIME soft key delivers up to 2 mL of priming fluid Fastest rate at which bolus
24. They display discrete accuracy data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug being infused and on the degree of intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered The start up curves represent continuous flow rate versus operating time for 2 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 Under conditions of 100 mmHg 100 mmHg and 300 mmHg pressures the Medley oyringe Module typically exhibits a long term accuracy offset of approximately 0 2 or less from the mean value NOTE Tests conducted in accordance with IEC EN 60601 2 24 Particular requirements for safety of infusion pumps
25. a delay is programmed the infusion stops when complete and no KVO is delivered Delaying Infusion The delay period for an infusion can be programmed as a specific number of minutes or a time of day as described in the following sections An infusion delay can be programmed prior to or after an infusion is initiated Specifying by Minutes The Delay for option is used to program an infusion delay for a minimum of 1 minute and up to 120 minutes 1 Press DELAY OPTIONS soft key 79 oO G D gt z G PN VAC 50 mL 40 min ALL gt Press START DELAY VOLUME CARTA START 2 Press Delay for soft key FY Delay Options oso Pause Delay for Delay until SAK gt Select a Delay Option BACK Syringe Module 8110 Series PROGRAMMING 61 Direction for Use Delay Options Continued Delaying Infusion Continued Specifying by Minutes Continued 3 To enter number of minutes up to 120 infusion is to be FY Delay Options 08 00 delayed for use numeric data entry keys Pause minutes Delay until CALL EAS BACK gt Enter Delay Time 1 120 min BACK 4 Press CONFIRM soft key PN Delay Options 08 00 Pause BEVAGA 20 minutes Delay until None gt Select Callback or Press CONFIRM Delay period counts down on Main Display Midtown Hospital i35 A Start in 20 min
26. can occur in the event of a single fault condition will not exceed 2 of nominal syringe fill volume during loading and 1 of maximum syringe travel after syringe loading Dimensions 4 5 W x 15 0 H x 7 5 D Environmental Conditions Operating Storage Transport H Temperature Range 41 to 104 F 4 to 140 F gt 5 to 40 C 20 to 60 C m Relative Humidity 20 to 90 5 to 85 Z i i gt Avoid prolonged exposure Noncondensing Noncondensing Z to relative humidity gt 85 2 Atmospheric Pressure 525 to 4560 mmHg 375 to 760 mmHg 700 to 6080 hPa 500 to 1013 hPa Equipment Orientation To ensure proper operation the Point of Care Unit must remain in an upright position Syringe Module 8110 Series MAINTENANCE 81 Direction for Use Specifications Continued Flow Rate Programming The flow rate range is from 0 01 to 999 mL h and can be selected as follows Flow Rates mL Selectable Increments mL h 0 01 9 99 0 01 10 99 9 0 1 100 999 1 Rate Restriction by Syringe Size syringe Size mL Flow Rate Range mL h 50 60 0 1 999 30 0 1 650 20 0 1 500 10 0 1 250 5 0 1 150 3 0 01 100 1 0 01 30 Fluid Ingress Protection IPK1 Drip Proof Infusion Pressure Maximum Without Pressure Sensing Disc Approximately 800 mmHg NOTE On a high setting the actual occlusion pressure will vary based on the syringe size and manufacturer With Pressure Sensing Disc 1060 mmHg KVO Keep Vein Open Rate
27. disc Is in use the Auto Pressure option is displayed in the Pressure Limit screen Auto Pressure automatically sets the alarm limit for a shorter time to alarm as follows e f current pressure is 100 mmHg or less system adds 30 mmHg to current pressure to create a new alarm limit e f current pressure is greater than 100 mmHg system adds 30 to current pressure to create a new alarm limit Auto Pressure Limit Adjustment When a bolus is delivered the pressure alarm limits are temporarily raised to the maximum limit Auto Syringe Size Identification The system automatically detects the syringe size and narrows down the syringe selection list Back Off This feature is only available when the administration set in use has a pressure sensing disc When enabled the motor reverses plunger movement during an occlusion until the pressure returns to preocclusion levels automatically reducing bolus flow Bolus Dose The Bolus Dose mode allows a bolus infusion to be programmed using either the Guardrails Drug Library or the drug calculation feature The bolus infusion can be programmed with or without a continuous infusion following the bolus Channel Labels The Channel Labels feature is available when the Profiles feature is enabled It provides a hospital defined list of labels displayed in the Message Display and identifying the module with the solution being infused the catheter location or other helpful information Concentra
28. mon 250 mg _ 50 mt PATIENT WEIGHT UNITS DOSING UNI Conc 5000 mcg mL gt Select PATIENT WEIGHT DRUG LIBRARY 44 PROGRAMMING Syringe Module 8110 Series Direction for Use Setting Up Drug Calculation Continued Using Non Library Drug Continued 8 To indicate whether or not patient weight is to be used in EA Drug Calculation Drug Calculation press either Yes or No soft key 250 mg 50 mL Yes NOTE Do not enter a patient weight if weight is not used in gt gt gt No the calculation Note Press Yes only if Patient weight is used in the calculation For Example Dosing Units mg kg h gt Use Patient Weight in Calculation DRUG 9 To enter patient weight if required in kilograms use FEY Drug Calculation numeric data entry keys 250 mg 50 mL ____kg UNITS Conc 5000 mcg mL gt Enter Patient Weight DRUG LIBRARY 79 oO G D gt z G 10 Press TIME UNITS soft key FAN Drug Calculation 250 mg 50 mL __70kg UNITS DOSING Conc 5000 mcg mL gt Select TIME UNITS DRUG LIBRARY 11 To select time base for drug calculation press either Min FEY Drug Calculation Hour or Day soft key 250 mg 50 mL 70 kg Min gt gt gt gt Hour UNITS Day Conc 5000 mcg mL gt Select Time Units DRUG LIBRARY
29. patient weight if specified by entering a patient weight e Continuous flow rate Drug dose Drug concentration normalized for patient weight if specified by entering a patient weight Drug concentration Drug amount Diluent volume e Total bolus dose Bolus dose not weight based bolus dose entered Bolus dose weight based bolus dose x patient weight Using Guardrails Drug Library When using a drug listed in the Guardrails Drug Library the Guardrails Software automatically calculates the drug parameters based on drug selected weight entry if required e rate or dose entry and e VTBI entry if other than All 79 oO G D gt z G 1 Perform steps in Start Up section to a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Perform steps in Preparing Infusion section to a Prepare syringe and administration set b Load syringe and administration set c Select syringe type and size and Guardrails Drug Library as infusion type d Prime Syringe Module 8110 Series PROGRAMMING 39 Direction for Use Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued 3 Press soft key next to desired drug and concentration NOTES To view additional drugs concentrations press a soft key next to a letter group to navigate
30. performed by qualified CLEANING As required service personnel START UP Each usage Service Information Reference the Medley Point of Care Unit DFU 86 MAINTENANCE Syringe Module 8110 Series Direction for Use WARRANTY ALARIS Medical Systems Inc hereinafter referred to as ALARIS Medical Systems warrants that A Each new ALARIS Medical Systems Medley Syringe Module is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by ALARIS Medical Systems to the original purchaser B Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by ALARIS Medical Systems to the original purchaser If any product requires service during the applicable warranty period the purchaser should communicate directly with the relevant account representative 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 o
31. pressing CONFIRM soft key to initiate delay during FA Delay Options 08 00 A Delay for or Delay until programming process press Pause CALL BACK soft key Delay fo x Delay unt BK None Q gt Select Callback or Press CONFIRM 2 Press soft key corresponding to desired callback option PN Delay Options 08 00 Pause e Scheduled callback appears on Main Display Delay for p Delay until 09 00 2992 CALL After BACK 22 gt gt gt gt None gt Select a Callback Option 3 To initiate delay press CONFIRM soft key FY Delay Options 08 00 Pause Delay for aE WANT O9 00 afer gt Select Callback or Press CONFIRM Continued on Next Page Syringe Module 8110 Series BROGRAFMIMINGUBE Direction for Use Delay Options Continued Scheduling a Callback Continued f Delay until programming time infusion is scheduled Mictown Hospital apo to start appears on Main Display A Start at 09 00 OR f Delay for programming delay period counts down Midtown WA 96 00 on Main Display A Start in 20 min VOLUME AUDIO INFUSED ADJUST f Before option was selected ance 000 A DELAY COMPLETE An audio prompt sounds when delay period has ended Yellow Standby Status Indicator flashes DELAY COMPLETE scrolls in Message Display and appears on Main Display VOLUME AUDIO INFUSED A
32. site location Radio Frequency Interference Operating the system near equipment which radiates high energy radio frequencies electrosurgical cauterizing equipment portable radios cellular telephones etc may cause false alarm conditions If this happens reposition the device away from the source of interference or turn off the device and manually regulate the flow with the clamp and or monitor the vital parameters using an appropriate clinical alternative Syringe Module 8110 Series INTRODUCTION 1 Direction for Use About the Syringe Module Continued Electromagnetic Compliance When using the Syringe Module in combination with a Point of Care Unit which is interconnected to hospital facility data communications eguipment and or nurse call systems signal input and signal output ports the external systems must be certified to applicable standards to ensure correct operation and electromagnetic compliance integrity Interconnected data communications systems must be certified to IEC 950 data processing equipment or IEC 60601 1 electromedical equipment Nurse call systems must be certified to UL 1069 hospital signaling and nurse call equipment or comply with the requirements specified in IEC 60601 1 EMC Compliance with the electromagnetic compatibility EMC standard IEC 60601 1 2 is a function of all interconnected equipment including cabling and as such it is the responsibility of the hospital facility to ensur
33. the following avoid an inadvertent bolus relieve ALL Mode Drug Calculation Dynamic Pressure Display the pressure before restarting the Profiles and Volume Duration configurable settings are infusion enabled Delay Options and NEOI configurable settings are disabled If Delay Options is enabled the PAUSE soft key becomes DELAY OPTIONS 79 oO G D gt z G 1 Perform steps in Start Up section to a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Perform steps in Preparing Infusion section to a Prepare syringe and administration set b Load syringe and administration set c Select syringe type and size and Basic Infusion as infusion type d Prime 3 Start an infusion as described in following Starting Rate Volume Infusion or Starting Volume Duration Infusion section Syringe Module 8110 Series PROGRAMMING 27 Direction for Use Basic Infusion Continued Starting Rate Volume Infusion 1 To enter flow rate press RATE soft key and use numeric E infusion Setup data entry keys ml n ALL gt Select RATE 2 To enter a numeric VTBI value instead of infusing ALL PN intusion Setup press VTBI soft key and use numeric data entry keys 40 mL h OR VIBI ALL To deliver entire contents of syringe leave VTBI as ALL NOTE When A
34. 0 9 NaCl A E A Label stops scrolling in Message Display O 3 NaCl F J GQ CVVHDF Dialysate K O x D5 1 2 NS PT S Epidural U Z Z Q gt Select Channel Label Ek 5 To begin infusion press START soft key FAN vac 50 mL 50 mL h OR ALL Program infusion as previously described gt Press START PAUSE GR Powering Off Reference the Medley Point of Care Unit DFU for the following procedures Powering Off System Powering Off Module Syringe Module 8110 Series PROGRAMMING 37 Direction for Use Setting Up Drug Calculation The drug calculation can be set up for a drug stored in the Guardrails Drug Library or for a non library drug as described in the following sections To access the drug library a hospital defined best practice data set must be uploaded using the Guardrails Safety Software and the Profiles feature must be enabled Drug Calculation Parameters The Medley System uses the following parameters entered during the drug calculation setup procedure Bolus dose duration Time period over which bolus dose is to be administered Bolus dose units Units used in calculating bolus dose Bolus dose units are selected from alternatives provided Diluent volume Volume of fluid used as diluent for drug mL Dosing units Units used to calculate continuous infusion drug dose Dosing Units are selected from alternatives provided e Drug amount Amount of drug in IV container
35. 4 GETTING STARTED Syringe Module 8110 Series Direction for Use Start Up Reference the Medley Point of Care Unit DFU for the following procedures Powering On System Responding to Maintenance Reminder Selecting New Patient and Profile Options Entering Patient ID Modifying Patient ID Preparing Infusion Administration Set G m G T gt A ar m O The Medley Syringe Module uses standard single use disposable syringes with luer lock connectors and administration sets designed for use on syringe pumps e For specific administration set instructions reference the directions for use provided with the set For a list of compatible syringes reference Compatible oyringes section in Maintenance chapter For a list of compatible administration sets refer to Set Compatibility Card provided separately Syringe Module administration sets are supplied with a sterile and nonpyrogenic fluid path for one time use Do not resterilize For administration set replacement interval refer to facility protocol and or government standards such as CDC guidelines in the United States Discard administration set per facility protocol For IV push medication put instrument on hold clamp tubing above the port Flush port s per facility protocol Use aseptic techniques when handling sets and syringes Syringe Module 8110 Series GETTING STARTED 15 Direction for Use Preparing Infusion
36. 8 00 RATE 20 mL h pose 10 mL INTERVAL every 06 h OF 4 doses gt Press START Main Display shows remaining VTBI for that dose eer S0800 A VTBI 10 mL VOLUME AUDIO INFUSED ADJUST e At completion of a multidose program MULTIDOSE MO eee COMPLETE appears on Main Display A MULTIDOSE COMPLETE NOTE If NEOI is enabled the Near End of infusion message appears near the end of the last dose VOLUME AUDIO INFUSED ADJUST 10 To see detail screen during or between infusions press FYMultidose 08 10 CHANNEL SELECT key Rate 20 mL h CSE AO m e During infusion Volume Remaining displays iis i every 06 h x 04 doses Doses completed 0 Volume remaining 7 mL gt Press START Continued on Next Page 74 PROGRAMMING Syringe Module 8110 Series Direction for Use Multidose Mode Continued Programming with Volume Duration Disabled Continued Between infusions EXMutidose 08 35 Number of doses completed and when next dose jd ib 40n starts displays Dose Yellow Standby Status Indicator illuminates every 06 h x 04 doses Doses completed 1 Dose 2 Starts 14 00 gt Press START Reviewing Serial Number Reference the Medley Point of Care Unit DFU Reviewing Software Version Reference the Medley Point of Care Unit DFU 79 oO G D gt
37. Conc 20 mg mL gt Select Rate or Dose SETUP BOLUS T To enter volume to be infused press VTBI soft key and eae eMe use numeric data entry keys CONTINUOUS INFUSION 27 0 min NOTE The BOLUS soft key appears only if Bolus Dose is mt enabled within the selected profile the drug is bolusable CZJ 9 momin and a VTBI is entered Conc 20 mg mL gt Select VTBI SETUP BOLUS Continued on Next Page Syringe Module 8110 Series PROGRAMMING 41 Direction for Use Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued Guardrails Drug Library NOTE When VTBI equals ALL the ALL soft key appears Lidocaine inactive when the VTBI soft key is pressed and active when netu edes a value is entered 27 0 muh ALL ALL 9 mg min Conc 20 mg mL gt Enter VTBI PAUSE SETUP BOLUS START Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 0 mun _ 50 mt ALL 9 mg min Conc 20 mg mL gt Press START PAUSE setup BoLus START 8 Verify parameters are correct and press START soft key ne ney Lidocaine CONTINUOUS INFUSION 27 mL n 50 mL 9 mg min Conc 20 mg mL gt Press START PAUSE SETUP BOLUS START NOTE If the programmed continuous dose infusion is py ae outside the Guardra
38. Continued Preparing Syringe and Administration Set manufacturer s directions for use manufacturer s directions for use Loading Syringe and Administration Set Prepare syringe reference Compatible Syringes section in Maintenance chapter in accordance with Prepare administration set refer to Set Compatibility Card provided separately in accordance with Attach upper fitting of administration set to syringe tip GUI 1 Use only standard single use disposable syringes with luer lock connectors and administration sets designed for use on syringe pumps The use of any other syringe or administration set may cause improper instrument operation resulting in inaccurate fluid delivery or pressure sensing or other potential hazards For a list of compatible syringes reference the Compatible Syringes section in the Maintenance chapter For a list of compatible administration sets reference the Set Compatibility Card provided separately WARNINGS AA Before loading the syringe check it for damage or defects e Ensure syringe barrel flange and plunger are installed and secured correctly Failure to install syringe correctly can result in uncontrolled fluid flow to the patient and may cause serious injury or death Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occu
39. DJUST f After option was selected EY i Th t infusion h An audio prompt sounds when delayed infusion eee completes and continues to sound until responded to Yellow Standby Status Indicator flashes until audio is silenced gt Press CONFIRM Infusion completed message appears on Main Display Infusion Complete scrolls in Message Display f Before and After option was selected same prompts and indicators mentioned above for both Before and After options are exhibited 66 PROGRAMMING Syringe Module 8110 Series Direction for Use Delay Options Continued Scheduling a Callback Continued 4 To respond to a callback Before callback Press CHANNEL SELECT key and then START soft key OR Press RESTART key After callback Press CONFIRM soft key Before and After callback Respond as indicated above for both Before and After Pausing Infusion 1 Press DELAY OPTIONS soft key FY vac 50 mL 40 mL h ALL 79 oO G D gt z G gt Press START DELAY VOLUME FA Eid START 2 Press Pause soft key EA Delay Options 09 30 Pause NOTES Delay for Using the Pause function in the Delay Options screen is Pee the same as pressing the PAUSE key on the Syringe Module The time displayed in the upper right corner of the screen Select a Delay Option is the time of day in a 24 hour clock
40. Directions for Use syringe Module 8110 Series CHANNEL Syringe Module ALARIS Medical Systems Inc Medley Medication Safety System OLL8 TSGOIN JTINGOW 39NIHAS GENERAL CONTACT INFORMATION Customer Advocacy North America Clinical and technical feedback Phone 800 854 7128 Ext 7812 E Mail CustomerFeedback alarismed com Technical Support North America Maintenance and service information support troubleshooting United States Canada Phone Phone 858 458 6003 Eastern 800 908 9918 800 854 7128 Ext 6003 Western 800 908 9919 Customer Care North America Instrument return service assistance and order placement United States Canada Phone Phone 800 482 4822 800 387 8309 TABLE OF CONTENTS INTRODUCTION ABOUT THE SYRINGE MODULE mentior teinte IR abb cac buco ola acd Dora o x ctr ti ita ird Ri anite 1 FEATURES AND DEFINITIONS 2 rk rte rd Eoo rt REIR OUS an do YE d her det eb Qe ka stet m tr E e t otis 3 ils Ka E ek eee AA es eee E EEE E 7 GETTING STARTED WARNINGS AND CAUTIONS wmamananamanaanwnnwanan a ees 9 General a ee ee ee ee ee ee 9 Guardrails Safety Software ummnnnmwnananamnanawananawwaa 10 Epidural Administration
41. LL MODE is disabled the VTBI ALL option is not available gt Press START 3 Attach administration set to patient s vascular access PAUSE RAIS device 4 Verify correct infusion parameter entry and press START Midtown Hospital soft key A _VTBI ALL 50 mL NOTE The infusion may be paused by pressing the PAUSE soft key Reference Pausing Infusion section VOLUME AUDIO INFUSED ADJUST Starting Volume Duration Infusion 1 Press VOLUME DURATION soft key FY infusion Setup mL h ALL gt Select RATE 28 PROGRAMMING Syringe Module 8110 Series Direction for Use Basic Infusion Continued Starting Volume Duration Infusion Continued 2 To enter a numeric VTBI value instead of infusing ALL FY infusion Setup press VTBI soft key and use numeric data entry keys RATE ___ mL h OR ALL h mm To deliver entire contents of syringe leave VTBI as ALL NOTE When ALL MODE is disabled the VTBI ALL option is not available Select DURATION 3 To enter volume duration press DURATION soft key and EXivAc 50 mL use numeric data entry keys RATE 50 mL h VIBI ALL e Rate is automatically calculated _ 1 00 hh mm 4 Attach administration set to patients vascular access 3 device O GQ gt Press START x PAUSE vie Z Z GQ 5 Verify correct infusion parameter entry and press
42. Orient pressure sensing disc as follows e fluid side up patient side down N e cavity forward membrane toward instrument zx Slot in Pressur aif b Gently slide pressure sensing disc up into slot in sensing Disc 7 Fluid Side pressure sensing disc housing Housing Pressure Ys Sensing Disc Patient Side c Apply firm upward pressure on pressure sensing disc not tubing until disc snaps into place d Pressure Sensing Disc 24 GETTING STARTED Syringe Module 8110 Series Direction for Use Preparing Infusion Continued Priming Continued Pressure Sensing Disc Used Installed Continued 7 To return to main screen press EXIT soft key e f EXIT soft key is pressed before pressure sensing disc is reinstalled a prompt to reinstall pressure sensing disc displays e f Basic Infusion was selected Infusion Setup screen displays and title alternates between Infusion Setup and identifying syringe model and size e f Guardrails Drug Library was selected Guardrails Drug Library screen displays Pressure Sensing Disc Not Used Installed 1 Press OPTIONS key 2 Press Prime Set with Syringe soft key Re install Pressure Sensing Disc gt Press CONFIRM CONFIRM A Infusion Setup mbh ALL gt Select RATE VOLUME DURA
43. PX1 Protection against fluid ingress Drip Proof N Attention Refer to accompanying documentation gt IUI Connector Inter Unit Interface connector used to establish power and communications between the Point of Care Unit and attached modules Manufacturing Date Number adjacent to symbol indicates the month and year of MM YYYY manufacture I li Consult operating instructions R Only CAUTION Federal U S A law restricts this device to sale by or on the order of a physician Single Use Single Use Do not re use Product contains micron filter where XX represents filter size Product contains a particular element such as DEHP in fluid pathway Product DOES NOT contain a particular element such as administration set is latex free Q VU zXX mid Approximate administration set priming volume Expiration date for product will be identified near hour glass symbol Do not use if package is damaged wa Syringe Module 8110 Series INTRODUCTION 7 Direction for Use THIS PAGE INTENTIONALLY LEFT BLANK 8 INTRODUCTION Syringe Module 8110 Series Direction for Use GETTING STARTED Warnings and Cautions Warnings and Cautions are provided throughout this R Only Directions for Use DFU to provide information needed to safely and effectively use the Medley Medication Safety System and its accessories Medley System Warnings and Cautions and definitions are covered in
44. R A PARTICULAR PURPOSE OR APPLICATION See packing inserts for international warranty if applicable Syringe Module 8110 Series MAINTENANCE 87 Direction for Use THIS PAGE INTENTIONALLY LEFT BLANK 88 MAINTENANCE Syringe Module 8110 Series Direction for Use APPENDIX ET Trumpet and Start Up Curves In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual syringes and administration sets cause short term fluctuations in rate accuracy The following graphs show typical performance of the system as follows 1 Accuracy during various time periods over which fluid delivery is measured trumpet curves N Delay in onset of fluid flow when infusion commences start up curves Trumpet and start up curves have been provided for 1 0 mL h and 5 0 mL h Measurements for trumpet curve rates below 1 0 mL h are not provided because of the difficulty in measuring extremely small volumes over a large duration of time In this case the linear relationship of the plunger position and velocity to syringe volume and rate is verified and is a function of the accuracy of the design Measurements for trumpet curve rates above 5 0 mL h are also not provided as the volume of the syringe will be displaced in a very short time with a rate of up 999 mL h Accuracy however is assured with the design implementation Trumpet curves are named for their characteristic shape
45. START Adutt GU oP soft key A _VTBI ALL 50 mL VOLUME AUDIO INFUSED ADJUST NOTE To view infusion Time Left press CHANNEL LY infusion Setup SELECT key To return to previous screen press START 50 mL h soft key ALL Time Left OO n 45 min gt Press START PAUSE ES START Syringe Module 8110 Series PROGRAMMING 29 Direction for Use Basic Infusion Continued Possible End of Infusion Messages and Alerts KVO VTBI Delayed Point of Care Unit Display Module Display Audio Visual Alert N A All Yes Syringe Empty Syringe Empty Yes Yes On All No Syringe Empty Syringe Empty Yes Yes Off All No Syringe Empty Syringe Empty Yes Yes N A Numeric Yes Complete Infusion Complete Yes Yes if an After callback is scheduled N A Numeric Yes Syringe Empty Syringe Empty Yes Yes Off Numeric No Complete Infusion Complete Yes Yes Off Numeric No Syringe Empty Syringe Empty Yes Yes On Numeric No Syringe Empty Syringe Empty Yes Yes Pausing Infusion NOTE To pause an infusion when Delay Options is enabled N vac 50 ml reference Delay Options Pausing Infusion section 90 mL h ALL 1 Press PAUSE key on Syringe Module OR Press CHANNEL SELECT key and then press PAUSE soft key on Point of Care Unit gt Press START PAUSE scrolls in Message Display PAUSE OUR e PAUSED appears on Main Display Yellow Standby S
46. Safety Software incorporates dosing limits and instrument configuration parameters based on hospital facility protocol The software adds a test of reasonableness to drug programming based on the limits defined by the hospital facility Qualified personnel must ensure the appropriateness of drug dosing limits drug compatibility and instrument performance as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates and pressure alarms and nuisance alarms e When loading a data set with the Guardrails Safety Software ensure the correct profile for patient care area is selected prior to starting an infusion Failure to use the appropriate profile could cause serious consequences Epidural Administration e Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient e tis strongly recommended that the syringe administration set and Syringe Module used for epidural drug delivery be clearly differentiated from those used for other types of administration The Medley System can be used for epidural administration of anesthetic and analgesic drugs This application is only appropriate when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use Use only a Medley System Gemini Series administration set without a Y connector or injection port fo
47. Setting 1000 mmHg Setting 1 120 minutes 105 minutes 5 30 minutes 30 minutes NOTE The Maximum Time to Alarm specifications are based on ALARIS Medical Systems standard operating conditions Atmospheric Pressure 645 795 mmHg Back Pressure 0 mmHg before producing occlusion Humidity 20 90 Temperature 68 4 F Range mL Increments mL 0 1 9 99 0 01 10 60 0 1 4 5 Ibs NOTE Compliance to Standards The Medley Medication Safety System has been assessed and complies with the following standards UL 60601 1 CSA C22 2 No 601 1 including A1 and A2 IEC EN 60601 2 24 IEC EN 60601 1 2 and AAMI ID26 Syringe Module 8110 Series Direction for Use MAINTENANCE 83 gt mr m 2 gt 2 OQ m Configurable Settings If the configuration settings need to be changed from the Factory Default settings reference the applicable Technical Service Manual or contact ALARIS Medical Systems Technical Support for technical troubleshooting and preventive maintenance information NOTE With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice data set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles System Settings Reference the Medley Point of Care Unit Directions for Use DFU Shared Infusion Settings Pump Module
48. TION ry Guardrails Drug Library Adult ICU Aminophylline 50mg 50mL A E Bretylium 50 mg 25mL F J Dobutamine mg mL K O Dopamine 40mg 50mL P T Dopamine 8mg 25mL U Z gt Select Drug Concentration CALC DOWN EXIT DRUG PAGE FA Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit High Prime Set with Syringe Channel Labels gt Select an Option or EXIT EXIT Syringe Module 8110 Series Direction for Use GETTING STARTED 25 G m G T gt A ar m O Preparing Infusion Continued Priming Continued Pressure Sensing Disc Not Used Installed Continued p Press and hold PRIME soft key until fluid flows and priming of syringe administration set is complete NOTE Fluid is delivered during priming only while the PRIME soft key is pressed Each press of the PRIME soft key delivers up to 2 mL of priming fluid per continuous Prime Set with Syringe CAUTION Do not prime with disposable set connected to patient Prime Volume press To deliver additional amounts press the PRIME soft Ont key ag ain gt Press and Hold PRIME Volume used during priming is displayed but not added PRIME EXIT to VTBI 4 When priming is complete release PRIME soft key A Prime Set with Syringe 9 To return to main screen press EXIT soft key CAUTION Do
49. and Syringe Module Feature Default Setting Options ALL Mode Disabled Enabled Disabled Delay Options Disabled Enabled Disabled e Callback None None Before After Before and After Drug Calculation Disabled Enabled Disabled e Bolus Dose Disabled Enabled Disabled Multidose Disabled Enabled Disabled e Callback None None Before After Before and After NEOI Disabled Enabled Disabled Alert Time 60 1 60 minutes or 25 of remaining infusion time whichever comes later Pressure Dynamic Disabled Enabled Disabled Dynamic Pressure Display Priming Disabled Enabled Disabled Volume Duration Disabled Enabled Disabled 84 MAINTENANCE Syringe Module 8110 Series Direction for Use Configurable Settings Continued Syringe Module Settings Feature Default Setting Options Auto Pressure Disabled Enabled Disabled Back Off After Occlusion Enabled Enabled Disabled Fast Start Enabled Enabled Disabled KVO Keep Vein Open Disabled Enabled Disabled Rate Adjust 1 mL h 0 1 2 5 mL h e Volume Adjust 5 0 5 5 Max Rate 999 mL h 0 1 99 9 mL h in 0 1 mL h increments 100 999 mL h in 1 mL h increments Occlusion Pressure Set Point e With Disc 1000 mmHg 25 1000 mmHg in 1 mmHg increments No Disc High Low Medium High Compatible Syringes The Medley Syringe Module is calibrated and labeled for use with the following single use disposable luer lock syringes Use only the syrin
50. and controllers and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers using B D Plastipak 60cc Syringe and ALARIS Medical Systems Administration Set 30910 Syringe Module 8110 Series Direction for Use APPENDIX 89 gt U U m Z z X Trumpet and Start Up Curves Continued Start Up Curve at 1 mL h initial 1 g mL Start Up Curve at 5 mL h initial 1 g mL mL h 0 2 A 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Time min Time min Trumpet Curve at 1 mL h initial Trumpet Curve at 5 mL h initial rr 15 gt 8 10 o un Pod o 5 3 LA wi 2 25 to nm ad Pa 3 S T WwW 424 10 17 br Eo 15 a a a a ee ae eT e Ot 10 15 20 25 30 0 5 10 15 20 25 30 Observation Interval min Observation Interval min Legend B Maximum rate error Overall rate error Minimum rate error 90 APPENDIX Syringe Module 8110 Series Direction for Use 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 ALARIS ALARIS Medical Systems Guardrails and Medley are trademarks and registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective ow
51. as correct the 71kg Message Display also shows either LLL for a low dose or DURATION 2 min i i for a high dose INFUSE AT 333 mg min Conc 20 mg mL gt Press START to Begin Infusing Bolus Dose CONT PAUSE SETUP SONT START 7 Verify parameters are correct and press START soft key A e Continued on Next Page 52 PROGRAMMING Syringe Module 8110 Series Direction for Use Bolus Dose Continued Using Guardrails Drug Library Calculation Continued NOTE To see details during the bolus infusion press the A TEES aaa CHANNEL SELECT key The screen title alternates between BOLUS DOSE Guardrails Drug Library drug name and identifying Remaining 5 mg kg syringe model and size Pt Weight 71 kg Time Left 2 min TOTAL DOSE 355 mg BOLUS VTBI 17 8 mL gt Press START to Continue Infusing Bolus Dose STOP PAUSE Sus START Using Non Library Drug Calculation 1 Setup Drug Calculation as described in Setting Up Drug Calculation Using Non Library Drug section but do not Start infusion 2 Press BOLUS soft key Al Drug Calculation DOSE is highlighted CONTINUOUS INFUSION ina RATE 4 2 muh 50 mL 5 meg kg min Conc 5000 mcg mL gt Press START 79 oO Q 79 gt z G PAUSE SETUP BOLUS START 3 To enter bolus dose use numeric data ent
52. ck Anesthesia Mode Bolus Dose Complete Delay Complete Infusion Complete Infusion Complete KVO NEOI Near End of Infusion Infusion completed Anesthesia Mode discontinued when disconnected from AC Module running in continuous infusion mode if programmed Delay time completed Current infusion completed Programmed volume to be infused delivered module running at KVO rate Syringe almost empty Response Press CONFIRM soft key Press CONFIRM soft key None Press RESTART key or press CHANNEL SELECT key and then START soft key Set up a new infusion or press CHANNEL OFF key Set up a new infusion or press CHANNEL OFF key None This is a timed event that can be set To set or change this option reference Configurable Settings section in Maintenance chapter Syringe Module 8110 Series Direction for Use ALARMS ERRORS MESSAGES 79 gt gt J m z o 9 gt m D p nO U o Messages Continued Message Meaning Panel Locked Panel Unlocked Pause Start time for next dose has passed syringe Not Recognized Tamper Resist feature is active and a key was pressed Tamper Resist feature deactivated Pause control pressed infusion stopped Start of next dose passed Installed syringe of unknown type and size Response If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of Point of Care
53. ck and hold plunger in place oavoid an occlusion when loading a smaller size syringe use extra care to close off administration set tubing and gently lower drive head against syringe plunger Forsmaller syringes such as 1 3 Or 5 CC stabilize the syringe plunger with thumb and index finger while carefully lowering the drive head Ensure the syringe plunger head makes contact with the small black sensor located on the bottom of the drive head between the plunger grippers 18 GETTING STARTED Syringe Module 8110 Series Direction for Use Preparing Infusion Continued Loading Syringe and Administration Set Continued 6 Insert pressure sensing disc if used as follows WARNING When the pressure sensing disc is not being used and an occlusion occurs there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion To Auto Pressure avoid an inadvertent bolus relieve Back Off Upon Occlusion the pressure before restarting the Customizable Pressure Alarm Settings see Occlusion infusion Pressure feature definition Dynamic Pressure Display see Pressure Tracking feature definition Fast Start NOTE The following are special Syringe Module features available only with extension sets fitted with a pressure sensing disc Reference the Features and Definitions section in the Introduction chapter for definitions G m G T gt A er m
54. continuous infusion is running a prompt to confirm the weight change appears Yes No gt Select Yes or No e Press BOLUS soft key E seis Drug Library CONTINUOUS INFUSION 0 83 mL n 50 mL 15 unitkg h Conc 200 units mL gt Press START Pause SETUP BOLUS START Continued on Next Page Syringe Module 8110 Series PROGRAMMING 51 Direction for Use Bolus Dose Continued Using Guardrails Drug Library Calculation Continued f To enter bolus dose use numeric data entry keys Py Gass Os tbe BOLUS DOSE DOSE _ _ __unit kg went 11 kg DURATION Conc 200 units mL gt Enter Bolus Dose SETUP 5 Press DURATION soft key A aloe ne Library BOLUS DOSE 5 mg kg 71g TOTAL DOSE 355 mg Conc 20 mg mL gt Select DURATION SETUP 6 To enter bolus duration use numeric data entry keys AA ale ong Library BOLUS DOSE OR 5 mg kg To deliver bolus dose at maximum safe rate possible for 71kg emun selected drug and setup and automatically calculate Duration min Ses bolus duration press Rapid Bolus soft key TOTAL DOSE 355 mg BOLUS VTBI 17 8 mL TOTAL DOSE alternates with INFUSE AT rate gt Enter Duration Lidocaine BOLUS DOSE NOTE If a continuous dose outside of the Guardrails Soft 9 mg kg Limits has been entered and verified
55. dose should be delivered as defined by facility s clinical best practice guidelines To simplify programming the Restore feature can be used to recall previous rate and volume settings for the same patient This option is only available if the patient is not new and the system is powered up within 8 hours of last usage The Selectable KVO option allows some infusions to automatically switch into KVO mode upon completion The KVO option setting cannot be changed after the instrument is powered on and a profile selected The instrument gives an alert and stops when an empty syringe is detected Syringe Module 8110 Series Direction for Use INTRODUCTION 5 A O O Cc i O Features and Definitions Continued Syringe Volume Detection The system automatically detects the fluid volume in a syringe when it is inserted Volume Duration The Volume Duration infusion option allows a volume to be infused VTBI and duration infusion time to be programmed The flow rate is automatically calculated 6 INTRODUCTION Syringe Module 8110 Series Direction for Use Symbols Canadian and U S Certification Mark Products bearing this mark have been tested gt ya and certified in accordance with applicable U S and Canadian electrical safety and performance standards CSA C22 2 No 601 1 UL 2601 1 and IEC 60601 2 24 gt c O G Electrical Shock Protection Rating Type CF Defibrillation proof 5 z I
56. e external equipment complies with the applicable EMC standards Failure to verify that external equipment meets applicable EMC standards may result in degraded electromagnetic compatibility Compliance with Federal Aviation Regulations The Medley Syringe Module has received a Statement of Compliance with Federal Aviation Regulations for use as a Portable Electronic Device Aboard Aircraft This is pursuant to the FAA Advisory Circular No 91 21 1A and attested by an FAA Designated Engineering Representative with an FAA form 8110 3 Statement of compliance with the Federal Aviation Regulations Contraindications None known This document provides directions for use for the Medley WARNING Syringe Module Read all instructions for both the Syringe Module and Point of Care Unit before using the Medley System NOTE The Medley Point of Care Unit was formerly known as the Medley Programming Module 2 INTRODUCTION Syringe Module 8110 Series Direction for Use Features and Definitions Reference the Alarms Errors Messages chapter of the Medley Point of Care Unit Directions for Use DFU for the definitions of various alerts Reference the Point of Care Unit DFU for system features and definitions All Mode When ALL is selected as the volume to be infused VTBI the entire contents of the syringe will be delivered A O O Cc i O Auto Pressure When enabled and a pressure sensing
57. e routes of administration such as intravenous IV intra arterial IA subcutaneous epidural enteral or irrigation of fluid spaces A O O Cc i O The Medley Syringe Module uses standard single use disposable syringes with luer lock connectors and administration sets designed for use on syringe pumps For specific administration set instructions reference the directions for use provided with the set For set priming and loading instructions reference the Preparing Infusion section in the Getting Started chapter of this document Artifacts It is normal for an infusion device to produce nonhazardous currents when infusing electrolytes These currents vary proportional to the infusion device flow rate When an ECG monitoring system is not functioning under optimal conditions these currents 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 Parallel Infusions There are no contraindications regarding the use of the Medley Syringe Module with any other positive displacement infusion device when ported together into a common IV
58. er appears on Main Display indicating it has been disabled Pump Module Change Air Detection 75 microliters gt Select an Option or Press CONFIRM Disconnecting System from AC Power While in Anesthesia Mode 1 Disconnect system from AC Anesthesia Mode is automatically disabled nme nesthesia mode was discontinued i i when AC power cord was All currently running infusions continue ear aceite Maa Aprompt appears as an alert that Anesthesia Mode has been discontinued 2 Press CONFIRM soft key Connecting System to AC Power While in Anesthesia Mode 1 Connect system to AC power 2 Tocontinue using Anesthesia Mode press Yes soft key AC power cord was OR connected Continue ANESTHESIA MODE No Yes To discontinue Anesthesia Mode press No soft key gt Select Yes or No 60 PROGRAMMING Syringe Module 8110 Series Direction for Use Delay Options Delay Options can be enabled at the time the Medley System is configured for use If Delay Options is enabled an infusion can be programmed to be delayed for a specified period of time and a callback can be scheduled as described in the following sections NOTE Since by definition an infusion with Delay Options will not be infusing for a programmed period of time it is assumed that another infusing IV line will keep the vein open until the delayed infusion begins When
59. es reference the Compatible Syringes section in the Maintenance chapter If the installed syringe is displayed and selected but is not recognized servicing is required reference Service Information section in Maintenance chapter Midtown Hospital Adult ICU A gt Select Channel VOLUME AUDIO INFUSED ADJUST 2 Press soft key next to installed syringe type and size e Selection is highlighted EYsyringe Selection BD 50 mL IVAC 50 mL MONO 50 mL gt Select Syringe Size 20 GETTING STARTED Syringe Module 8110 Series Direction for Use Preparing Infusion Continued Selecting Syringe Type and Size Continued 3 To accept press CONFIRM soft key EASyringe Selection BD 50 mL IVAC 50 mL MONO 50 mL GQ gt Confirm Syringe Size m z GQ o 4 Press soft key next to applicable infusion type Basic FA infusion Menu 2 Infusion or Guardrails Drug Library Guardrails Drug Library Basic infusion J NOTE The RESTORE soft key appears only if there had been a previous infusion programmed for the same patient gt Select an Option or EXIT RESTORE EXIT If Basic Infusion was selected Infusion Setup EE infusion Setup screen displays and title alternates between Infusion mL h Setup and identifying syringe model and size ALL
60. f 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 repaired by anyone other than an authorized ALARIS Medical Systems Service Representative b 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 mr m 2 gt 2 ie m ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FO
61. format military time 3 Press CONFIRM soft key FA Delay Options 09 30 Pause e PAUSE scrolls in Message Display e PAUSED appears on Main Display Delay until Yellow Standby Status Indicator illuminates BACK After 2 minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status gt Press CONFIRM Indicator flashes Syringe Module 8110 Series PROGRAMMING 67 Direction for Use Delay Options Continued Pausing Infusion Continued 4 To reinitiate infusion EX vac 50 mL 40 mL h Press RESTART key WA OR Press CHANNEL SELECT key and then START soft key gt Press START DELAY VOLUME ESSA E START Multidose Mode NOTES UNUS 3 e Since by definition a multidose infusion will not be infusing The Multidose feature is to be for a programmed period of time it is assumed that another used only by personnel properly infusing IV line will keep the vein open until the beginning of trained in using multidose the first dose and between subsequent doses There is no infusions keep vein open KVO infusion at the completion of a i i programmed Delay until infusion Caution labels which clearly differentiate single dose and multidose containers must be The Delay Options function for multidose infusions is similar utilized to Delay Options for continuous drug infusions with the following differences ALL Mode is no
62. ge size and type specified on the Main Display The full list of permitted syringe models is dependent on the Syringe Module s software version Manufacturer 1cc 3CC 5cc 6cc 10cc 12cc AstraZeneca B D Plastipak X X X X IVAC Monoject X x x Terumo x X x 3 1 Prefilled Diprivan 2 The Monoject SoftPack Luer Lock Syringe blister pack is the only currently supported Monoject 3cc 3 The Terumo 5cc doubles as a 6cc and the 10cc doubles as a 12cc CAUTION When using a 10cc or smaller syringe ALARIS Medical Systems strongly recommends using an extension set with a pressure disc for improved pressure monitoring and shorter times to occlusion alarm 20cc 30cc 35cc 50cc 60cc X X x x x x x x x x x x x x Syringe Module 8110 Series Direction for Use MAINTENANCE 85 gt m 2 gt 2 ie m Reference the Medley Point of Care Unit DFU Inspection Requirements To ensure the system remains in good operating condition WARNING both regular and preventive maintenance inspections are DURAS Failure to perform these inspections required Reference the Medley Maintenance Software User mavresitipimproperis rumen Manual Model 8970C or later for detailed instructions uen xs REGULAR INSPECTIONS PROCEDURE FREQUENCY CAUTION INSPECT FOR DAMAGE Exterior Surfaces Each usage Regular and preventive Keypad Each usage maintenance inspections should Mechanical Parts Each usage only be
63. gram mg mcg mEq or units Patient weight Weight of patient kg this is an optional parameter that is not needed unless drug dose is normalized for patient weight Time units Time base for all calculations minute hour or day The bolus dose drug dose and flow rate parameters are calculated using the above parameters as follows Bolus dose Bolus dose x Patient weight if used e Bolus dose administration rate INFUSE AT When duration is entered total dose duration in minutes When Max Rate is used Max Rate 60 x concentration e Bolus dose duration Bolus VTBI Bolus rate Bolus dose VTBI Bolus dose Drug concentration e Bolus rate Bolus VTBI Duration Continued on Next Page WARNINGS The Drug Calculation feature is to be used only by personnel properly trained in the administration of continuously infused medications Extreme caution should be exercised to ensure the correct entry of the drug calculation infusion parameters References in this document to specific drugs and drug doses are for illustration purposes only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages 38 PROGRAMMING Syringe Module 8110 Series Direction for Use Setting Up Drug Calculation Continued Drug Calculation Parameters Continued e Continuous drug dose Flow rate x Drug concentration normalized for
64. hannel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit High Prime Set with Syringe Channel Labels gt Select an Option or EXIT EXIT Syringe Module 8110 Series PROGRAMMING 33 Direction for Use Basic Infusion Continued Selecting Pressure Limit Continued Pressure Sensing Disc Not Installed Continued 4 To select a pressure limit press appropriate soft key Al Low Med or High Pressure Limit Selection 5 Press CONFIRM soft key sil Viewing and Clearing Volume Infused 1 To view volume infused press VOLUME INFUSED soft key Midtown Hospital Adult ICU A VTBI ALL 42 5 mL B vrB ALL 48 1 mL Total volume infused and time and date volume infused was last cleared display for each module NOTES e Date format is year month day e f a Pump Module is attached a PRI SEC VOLUME soft key is available to allow secondary volume infused to em E be displayed e f no key is pressed main screen appears after 30 seconds 2 To clear volume infused Volume Infused TOTAL VOLUME mL cL ARED NOTE If no key is pressed main screen appears after Al 42 5 J 30 seconds B 48 1 2602 10 e If only selected modules are to be cleared press soft key next to applicable module s and press CLEAR CHANNEL soft key gt Select Channels to Clear or Press CLEAR ALL Volume clea
65. he Yes soft key is pressed programming continues if the No Soft key is pressed the infusion needs to be reprogrammed e fthe programmed continuous dose infusion is outside the Guardrails Hard Limit for that care area a prompt appears before programming can continue The infusion needs to be reprogrammed 3 To enter bolus dose use numeric data entry keys E Z NOTE After a bolus dose and weight if used are entered e bolus VTBI and concentration conc alternate in the Main T Display e If no weight has previously been programmed in AA er system and bolus dose is weight based weight entry BOLUS DOSE o is empty D mg WEIGHT Conc 20 mg mL gt Enter Bolus Dose f programmed continuous dose is weight based A E programmed weight displays as in illustrated example BOLUS DOSE which reflects use of Heparin in Pediatrics ICU CZ ____ unig wacht 10kg Conc 200 units mL gt Enter Bolus Dose e f bolus dose is not weight based Not Used displays in PATIENT WEIGHT field Syringe Module 8110 Series PROGRAMMING 49 Direction for Use Bolus Dose Continued Using Guardrails Drug Library Calculation Continued 4 To enter or change patient weight if used use applicable following procedure depending on whether or not continuous dose is weight based When continuous dose is not weight based a Press PATIENT WEIGHT soft key A Ong COTON Lid
66. ils Soft Limit for that care area a Dose exceeds Yes i Guardrail limit of prompt appears before programming can continue If the 8 mg min No Yes soft key is pressed programming continues if the No Proceed soft key is pressed the infusion needs to be reprogrammed gt Press Yes or No Continued on Next Page 42 PROGRAMMING Syringe Module 8110 Series Direction for Use Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued EXE Drug Library Lidocaine NOTES Dose exceeds Reprogram e fthe programmed continuous dose infusion is outside Guardrails hard the Guardrails Hard Limit for that care area a prompt ron RIO appears before programming can continue The infusion needs to be reprogrammed fa dose outside of the Guardrails Soft Limits has been entered and verified as correct the Message Display ka USQUE also shows either LLL for a low dose or TT for a high dose Using Non Library Drug The following procedure should be used only when the drug to be infused is not listed in the Guardrails Drug Library When programming a drug not listed in the Guardrails Drug Library 3 the drug calculation must be programmed using the DRUG S CALC soft key within the Guardrails Drug Library There are s no Guardrails Limits associated with any non library drug calculation 1 Perf
67. ime Change Medley Point of Care Unit DFU NOTE If the current time has been previously confirmed the Time of Day screen will not be displayed gt CONFIRM Time of Day 6 Press VOLUME DURATION soft key FY Multidose 08 00 mL h gt Enter Rate Syringe Module 8110 Series PROGRAMMING 69 Direction for Use Multidose Mode Continued Programming with Volume Duration Enabled Continued 7 To enter volume to be infused for each dose use numeric data entry keys ry Multidose 08 00 RATE mL h VOLUME DOSE mL DURATION DOSE INTERVA HOF JOCO gt Enter Volume Dose RATE VOLUME 8 To enter duration for each dose press DURATION soft key and use numeric data entry keys NOTE RATE is calculated with each keystroke for DURATION A Multidose 08 00 RATE mL h 10 mL CR hn min DOSE gt Enter Duration RATE VOLUME 9 To enter time interval 1 to 24 hours between doses press DOSE INTERVAL soft key and use numeric data entry keys A Multidose 08 00 RATE 20 mL h 10 mL EE 30 hh mm INTERVAL gt Select DOSE INTERVAL RATE VOLUME 10 To enter number of doses press OF DOSES soft key and use numeric data entry keys e f Delay Options is enabled DELAY OPTIONS soft key appears NOTE Reference Delay Options sectio
68. infusion is first started taking up any slack in the drive mechanism The Guardrails Drug Library feature is a drug calculation mode available when the Profiles feature is enabled It provides a hospital defined list of drugs and concentrations appropriate for use in aS many as 10 profiles Using the Drug Library automates programming steps including the drug name drug amount and diluent volume and activates the hospital established best practice Guardrails Limits A Guardrails Limit is a programming limit or best practice guideline determined by the hospital facility and entered into the system s data set Supports concentration limits for all infusions that utilize concentration Profile specific limits are defined for flow rate patient weight and maximum and minimum continuous dose for each drug in a Guardrails Drug Library Dose limits can be defined by the hospital facility as either hard or soft limits e A Guardrails Hard Limit is a programmed limit that cannot be overridden except in anesthesia mode e A Guardrails Soft Limit is a programmed limit that can be overridden The Multidose Mode option allows 2 24 doses to be programmed at equally spaced intervals on the same Syringe Module over a 24 hour period This mode is designed to allow delivery of multiple equal doses from the same syringe at regularly scheduled intervals 4 INTRODUCTION Syringe Module 8110 Series Direction for Use
69. ing Non Library Drug Continued 15 To enter volume to be infused press VTBI soft key and PN Drug Calculation use numeric data entry keys CONTINUOUS INFUSION 4 2 ml n NOTE The BOLUS soft key appears only if Bolus Dose is 00 m enabled within the selected profile and a VTBI is entered FEE 5 mogkgimin Conc 5000 mcg mL gt Select VTBI SETUP BOLUS NOTE When VTBI equals ALL the ALL soft key appears LY Drug Catcutation inactive when the VTBI soft key is pressed and active when CONTINUOUS INFUSION a value is entered 4 2 muh ALL 5 meg kg min Conc 5000 mcg mL gt Press START PAUSE seTUP BoLus START 79 oO G D gt z G A Drug Calculation CONTINUOUS INFUSION 4 2 mL h 5 0m ALL 5 meg kg min Conc 5000 mcg mL gt Press START PAUSE SETUP BOLUS START 16 Verify parameters are correct and press START soft key FA Drug Calculation CONTINUOUS INFUSION 4 2 mL h 50 mL 5 meg kg min Conc 5000 mcg mL gt Press START PAUSE SETUP BOLUS START Syringe Module 8110 Series PROGRAMMING 47 Direction for Use Bolus Dose A bolus dose can be programmed at the beginning of or during an infusion The drug being programmed must be a bolusable drug selected from the Guardrails Drug Library or a non library drug as described in the following sections
70. lect an Option or EXIT 58 PROGRAMMING Syringe Module 8110 Series Direction for Use Anesthesia Mode Continued Enabling Anesthesia Mode Continued 3 Press Enable soft key System Options 4 Press CONFIRM soft key meee Enable Pump Module Change Air Detection 75 microliters gt Select an Option or Press CONFIRM 5 Press Channel Select key Midtown Hospital 6 Program Anesthesia Mode infusion using same A procedure as for any other continuous infusion G D Anesthesia Mode VOLUME AUDIO INFUSED ADJUST 79 oO G D gt z G Disabling Anesthesia Mode The Anesthesia Mode can be disabled and normal operation resumed using either of the following 3 methods e System Options menu e Disconnecting system from AC power Connecting system to AC power From System Options Menu 1 While operating in Anesthesia Mode press OPTIONS key 2 Press Anesthesia Mode soft key System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT Syringe Module 8110 Series PROGRAMMING 59 Direction for Use Anesthesia Mode Continued Disabling Anesthesia Mode Continued From System Options Menu Continued 3 Press Disable soft key System Options 4 Press CONFIRM soft key MM Enable Anesthesia Mode no long
71. n Status Indicators Plunger Grippers shown in closed position Alarm Infusing Standby red green yellow IUI Connector Left Barrel Flange Grippers YO ELI Syringe Barrel Sensor IUI Connector Right Channel Module Select Key When pressed selects corresponding module for infusion parameter entry and infusion qe Syringe Barrel Clamp setup SELECT Pause Key When pressed Lb during an infusion temporarily stops infusion on that module S Sizer After approximately 2 minutes a visual and audio prompt begins v ige Module Nl Channel Module Off Key When pressed and held until a beep is heard stops infusion on that module deselects that module and if only that module had been operating system powers down Repeat for other operating modules to power off each module PE Pressure Transducer Pressure Sensing Disc Housing gt Restart Key When pressed resumes operation of a previously paused or alarmed infusion on that Channel Module Release Latch module When pressed allows module to be removed Syringe Module 8110 Series GETTING STARTED 13 Direction for Use G m G T gt A er m O Installation Instruments are tested and calibrated before they are packaged for shipment To ensure proper operation after shipment it is rec
72. n or press If syringe is not empty other CHANNEL ORS KEY possibilities are Pressure sensing disc gt Verify appropriate pressure sensing inappropriate defective disc is in use and functioning properly e Syringe plunger travel gt Verify syringe plunger movement is impeded unimpeded e Pressure transducer defective gt If syringe is not empty and above actions do not correct alarm contact qualified service personnel Syringe Module 8110 Series ALARMS ERRORS MESSAGES 77 Direction for Use Alarms Continued Syringe Adjustment Alarms When a syringe installation problem is detected a visual signal is displayed Text in the display blinks to indicate the location of the problem e When problem is corrected press CONFIRM soft key Alarm Meaning Check Syringe Plunger grippers opened during infusion and then closed Infusion stops on affected module Syringe barrel clamp opened during infusion and then closed Infusion stops on affected module Syringe plunger not captured while in idle state System alarms after 30 seconds to indicate potential siphoning condition Drive Not Engaged Drive system disengaged during operation Syringe Installation Z lever plunger JD fl ange J i clamp gt Press CANCEL or Adjust Syringe Syringe Installation lever plunger flange clamp gt Press CONFIRM CONFIRM Res
73. n to program an infusion delay When delaying an infusion a multidose cannot be delayed for more than 8 hours and all doses in the multidose program must be completed within a 24 hour program A Multidose 08 00 RATE 20 mL h 10 mL 00 h 30 min every 6h DOSES gt Select NUMBER OF DOSES RATE VOLUME 70 PROGRAMMING Syringe Module 8110 Series Direction for Use Multidose Mode Continued Programming with Volume Duration Enabled Continued 11 To begin multidose infusion press START soft key e Main Display shows remaining VTBI for that dose e At completion of a multidose program MULTIDOSE COMPLETE appears on Main Display NOTE If NEOI is enabled the Near End of infusion message appears near the end of the last dose EY Multidose 08 00 RATE 20 mL h 10 mL 00 h 30 min every 06 h _ 4 doses gt Press START PAUSE ge he START Midtown Hospital Adult ICU 08 00 A VTBI 10 mL VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU 02 30 AQ MULTIDOSE COMPLETE VOLUME AUDIO INFUSED ADJUST 12 To see detail screen during or between infusions press CHANNEL SELECT key During infusion Volume Remaining displays Continued on Next Page A Multidose 08 10 Rate 20 mL h Volume _ Dose 10 mL Duration OO n 30 min every 06 h x 04 doses Doses completed O
74. ners Patents Patented Brevets Brevetti Patente Patenten Patenter Patentes Kar E 4 US 4 690 673 4 764 166 5 096 385 5 165 873 5 601 445 5 681 285 5 713 856 5 800 387 5 836 910 5 941 846 6 269 340 AU 596 552 634 811 693 662 703 178 703 203 719 254 728 366 CA 1 258 212 1 296 092 2 026 518 2 029 267 2 2125 693 DE P3686558 3 P690244923 6900700312 69329774 ES 2 154 651 HK 1 006 006 JP 1 816 872 2 594 604 7 502 678 SG 49 695 TW NI 107963 EP0225158 AT BE CH FR IT NL SE UK EP0649316 DK EP0422855 FR UK EP0431310 FR UK Other Patents Pending 10010719 RevOO 02003 2004 ALARIS Medical Systems Inc All Rights Reserved Syringe Module 8110 Series Direction for Use
75. ng Bolus Dose Continued Bolus Dose Completed Module Turned Off Continued 3 Verify parameters and press NEXT soft key FEY Suardrails Drug Library Lidocaine DRUG 1 gram DILUENT 50 mt PATIENT WEIGHT Not Used TIME UNITS min Bg mgimin Conc 20 mg mL gt Press NEXT to Confirm NEXT 4 Verify infusion parameters and press BOLUS soft key Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 mL h 50 mL 9 mg min Conc 20 mg mL gt Press START 79 oO Q 79 gt z G PAUSE SETUP BOLUS START 9 Press RESTORE soft key EXC egenum Lidocaine BOLUS DOSE Dose 02 Welch f1 kg Conc 20 mg mL gt Enter Bolus Dose CONT RESTORE SETUP NTE 6 Verify dosing parameters and press START soft key EY Sarai Drug Library Lidocaine BOLUS DOSE 5 maiko 71 kg 2 min INFUSE AT 333 mg min Conc 20 mg mL gt Press START to Begin Infusing Bolus Dose CONT Pause SETUP SEN START Syringe Module 8110 Series PROGRAMMING 57 Direction for Use Anesthesia Mode When the Medley System is operating in Anesthesia Mode a module can be paused indefinitely without an alarm Anesthesia Mode also makes it possible to have additional drugs in each profile which are only accessible when operating in Anesthesia Mode NOTE When the Ane
76. ocaine BOLUS DOSE 5 mg kg ES REG Kg DURATION Conc 20 mg mL gt Select PATIENT WEIGHT SETUP b Toenter patient weight use numeric data entry A Suardraits Drug Library keys BOLUS DOSE Dose 5 mg kg ES _ _ _ s Conc 20 mg mL gt Select DURATION SETUP OR e When continuous dose is weight based a Press SETUP soft key LY Guardrails Drug Library Heparin BOLUS DOSE DOSE __ 50 unit kg weist 10 kg TOTAL DOSE 500 units Conc 200 units mL gt Select DURATION Continued on Next Page 50 PROGRAMMING Syringe Module 8110 Series Direction for Use Bolus Dose Continued Using Guardrails Drug Library Calculation Continued b Press PATIENT WEIGHT soft key A BI A Heparin 10000 units 50 mL 10 kg Units Hour DOSING units kg h Conc 200 units mL gt Press NEXT to Confirm DRUG ee NEXT c To change patient weight use numeric data entry uda Brg Library eparin keys 10000 units d Press NEXT soft key 50 p aay EE kg WES Hour POSING units kg h Conc 200 units mL gt Press NEXT to Confirm DRUG LIBRARY NEKT 79 oO G D gt z G Al Guardrails Drug Library Heparin Dose will recalculate based on new weight Adjust Dose or Rate if required Accept weight change NOTE If a
77. ommended that an incoming inspection be performed before placing the instrument into use Prior to placing the Medley System in use Perform check in procedure per Medley Maintenance Software User Manual Model 8970C or later Attaching and Detaching Modules Reference the Medley Point of Care Unit DFU Displays The displays illustrated throughout this document are for illustration purposes only The display content will vary depending on configuration settings type of administration set in use hospital defined data set uploaded using the Guardrails Safety Software programmed drug calculation parameters and many other variables Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages Main Display Reference the Medley Point of Care Unit DFU Dynamic Pressure Display Midtown Hospital A Tl N Adult ICU P C U O VTBI 250 0 mL Although the dynamic pressure display bars for the Medley Syringe Module and Pump Module both use the full width of the screen for display they each represent different ranges The Syringe Module s range is 0 to 1000 mmHg C D Dynamic Pressure Display ag Current operating pressure is indicated by solid bar SOGGO N Patient side occlusion pressure set point is indicated by tick se pm A 1
78. orm steps in Start Up section to a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Perform steps in Preparing Infusion section to a Prepare syringe and administration set b Load syringe and administration set c Select syringe type and size and Guardrails Drug Library as infusion type d Prime 3 Press DRUG CALC soft key A Rene Drug Library Aminophylline 50mg 50mL AE Bretylium 50 mg 25mL F J Dobutamine mg mL KO Dopamine 40mg 50mL PT Dopamine 8mg 25mL vya gt Select Drug Concentration CREE Syringe Module 8110 Series PROGRAMMING 43 Direction for Use Setting Up Drug Calculation Continued Using Non Library Drug Continued 4 To enter DRUG AMOUNT in syringe use numeric data FEY Drug Calculation entry keys ER meg VOLUME mg gram TE unit gt Enter Amount of Drug in Container 5 Press soft key for appropriate unit of measure for drug FEY Drug Calculation amount KM 250 mcg E mg gram EI unit gt Select Unit of Measure DRUG LIBRARY 6 Toenter diluent volume use numeric data entry keys FA Drug Calculation DRUG 250 mg DILUENT NDS mL PATIENT WEIQUT gt Enter Diluent Volume DRUG LIBRARY 7 Press PATIENT WEIGHT soft key FEY Drug Calculation
79. ponse Securely lock plunger grippers press CHANNEL SELECT key and reselect syringe Securely lock syringe barrel clamp and press RESTART key Check for potential siphoning Ensure administration set clamp roller slide is in closed position Securely lock plunger grippers over syringe plunger Open and close plunger grippers and syringe barrel clamp Ensure syringe is properly installed 78 ALARMS ERRORS MESSAGES Syringe Module 8110 Series Direction for Use Error Meaning Channel Error Syringe Calibration Required Syringe Driver Head Error Error detected Operation stops on affected module Error on infusing module indicating calibration is required Infusion stops on affected module CALIBRATE scrolls in Message Display Noninfusing module with plunger grippers open senses excessive pressure being applied downward on Drive Head OCCLUSION scrolls in Message Display Response To silence alarm and continue operation of unaffected modules press CONFIRM soft key Replace module with an operational instrument as required Service by qualified personnel is required To silence alarm and continue operation of unaffected modules press CONFIRM soft key Replace module with an operational instrument as required Service by qualified personnel is required To silence alarm and continue normal operation press CONFIRM soft key Messages Message Meaning After Call Ba
80. r epidural infusions Epidural administration of anesthetic drugs Use indwelling catheters specifically indicated for short term 96 hours or less anesthetic epidural drug delivery Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery 10 GETTING STARTED Syringe Module 8110 Series Direction for Use Warnings and Cautions Continued Administration Sets Use only standard single use disposable syringes with luer lock connectors and administration sets designed for use on syringe pumps The use of any other syringe or administration set may cause improper instrument operation resulting in an inaccurate fluid delivery or pressure sensing or other potential hazards For a list of compatible syringes reference the Compatible Syringes section in the Maintenance chapter For a list of compatible sets reference the Set Compatibility Card provided separately Before loading or unloading the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and may cause serious injury or death When the pressure sensing disc is not being used and an occlusion occurs there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion To avoid an inadvertent bolus
81. r when the administration set is not clamped or turned off and may cause serious injury or death CAUTION When initially loading the syringe allow for the volume of fluid contained in the administration set and retained in the syringe at the end of an infusion as this dead space will not be infused 16 GETTING STARTED Syringe Module 8110 Series Direction for Use Preparing Infusion Continued Loading Syringe and Administration Set Continued 1 Open syringe barrel clamp a Pull syringe barrel clamp out and hold b Rotate clamp to left clockwise or counter clockwise until it clears syringe chamber c Gently release clamp Syringe Barrel Clamp Open 2 Raise drive head to its fully extended position a Twist gripper control clockwise and hold in position NOTE The gripper control is spring loaded When twisted to the open position and then released it and the plunger grippers will return to the closed position b While holding gripper control in open position raise drive head to full extension c Gently release gripper control G m G T gt A er m O Drive Head Fully Extended MEE Gripper Control Driv Head Release in Open Position Plunger Grippers Open 3 Insert syringe from front of instrument
82. relieve the pressure before restarting the infusion When priming Ensure patient is not connected Ensure air is expelled from line prior to beginning infusion unexpelled air in line could have serious consequences Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient Ensure the syringe manufacturer and syringe size displayed matches syringe manufacturer and syringe size installed in the Medley Syringe Module Mismatches may cause an under infusion or over infusion to the patient that could result in serious injury and or death For a list of compatible syringes reference the Compatible Syringes section in the Maintenance chapter Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient Discard if packaging is not intact or protector caps are unattached Syringe Module 8110 Series Direction for Use GETTING STARTED 11 G m G T gt A ar m O Warnings and Cautions Continued Administration Sets Continued CAUTIONS Before operating instrument verify that administration set is free from kinks and installed correctly in instrument 12 GETTING STARTED Syringe Module 8110 Series Direction for Use Operating Features Controls and Indicators Gripper Control Drive Head Release shown in closed positio
83. rogrammed using the Guardrails Drug Library Even where the displays are different when restoring a bolus dose which was programmed using a non library drug the procedure is the same Syringe Module 8110 Series PROGRAMMING 55 Direction for Use Bolus Dose Continued Restoring Bolus Dose Continued Bolus Dose Completed Module Not Turned Off 1 Press CHANNEL SELECT key 2 Verify infusion parameters and press BOLUS soft key Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 mL h 50 mL 9 mg min Conc 20 mg mL gt Press START PAUSE SETUP BOLUS START 3 Press RESTORE soft key A Ue dd Lidocaine BOLUS DOSE DOSE _ _ _ __ mg kg weient f1 kg Conc 20 mg mL gt Enter Bolus Dose Restore SETUP CONT INUOUS 4 Verify dosing parameters and press START soft key EY Sarge Drug Library Lidocaine BOLUS DOSE 5 maig 71 kg 2 min INFUSE AT 333 mg min Conc 20 mg mL gt Press START to Begin Infusing Bolus Dose CONT PAUSE SETUP CONT START Bolus Dose Completed Module Turned Off 1 Press CHANNEL SELECT key 2 Press RESTORE soft key FA infusion Menu Guardrails Drug Library Basic infusion gt Select an Option or EXIT RESTORE EXIT 56 PROGRAMMING Syringe Module 8110 Series Direction for Use Bolus Dose Continued Restori
84. rs on selected module s e f all modules are to be cleared press CLEAR ALL soft key To return to main screen press MAIN SCREEN soft key 34 PROGRAMMING Syringe Module 8110 Series Direction for Use Basic Infusion Continued Changing Syringe During Infusion 1 To stop infusion press PAUSE key on Syringe Module 2 Open plunger grippers and syringe barrel clamp e An audio prompt sounds to silence press SILENCE key e Red Alarm Status Indicator flashes CHECK SYRINGE scrolls in Message Display 3 Remove syringe and separate administration set from syringe 4 Reattach administration set to new syringe reference Preparing Infusion section in Getting Started chapter 5 Load new syringe reference Preparing Infusion section in Getting Started chapter 6 Select syringe type and size reference Preparing Infusion section in Getting Started chapter Press CONFIRM soft key 79 oO G D gt z G Prime administration set reference Preparing Infusion section in Getting Started chapter 9 Press RESTORE soft key OR To enter VTBI and rate press RATE soft key and use numeric data entry keys and then VTBI soft key and use numeric data entry keys 10 To begin infusion press START soft key Syringe Module 8110 Series PROGRAMMING 35 Direction for Use Channel Labels Selecting Channel Label Press CHANNEL SELECT key
85. ry keys FY Drug Calculation BOLUS DOSE meg NOTE After a bolus dose and weight if used are entered E 2000 mcg kg bolus VTBI and concentration conc alternate in the Main PATIENT mg Display DURATION mg kg Conc 5000 mcg mL gt Select the Desired Dosing Units 4 Press soft key for appropriate unit of measure for dose NOTE If mcg or mg is selected as the dosing unit a PATIENT WEIGHT entry cannot be made If mcg kg or mg kg is selected as the dosing unit a PATIENT WEIGHT entry is required Syringe Module 8110 Series PROGRAMMING 53 Direction for Use Bolus Dose Continued Using Non Library Drug Calculation Continued 5 To enter bolus duration use numeric data entry keys KY Drug Calculation BOLUS DOSE TOTAL DOSE alternates with INFUSE AT rate 2000 meg PATIENT DURATION min TOTAL DOSE 2000 mg Conc 5000 mcg mL gt Enter Duration SETUP 6 Verify parameters are correct and press START soft key FY Drug Calculation BOLUS DOSE 2000 meg PATIENT Not Used lt 1 min INFUSE AT gt 9999 mcg min Conc 5000 mcg mL gt Press START to Begin Infusing Bolus Dose PAUSE SETUP ius START NOTE To see details during the bolus infusion press the FAN Drug Calculation CHANNEL SELECT key BOLUS DOSE Dose Remaining 2000 meg Pt Weight Not Used Time Left lt 4 min TOTAL DOSE 2000 mcg BOLUS VTBI 0 4 mL
86. s Drug Library Lidocaine Clinical Advisory Watch IV site carefully for signs of extravasation gt Press CONFIRM CONFIRM A Guardrails Drug Library Lidocaine UG tomm DILUENT 50 mL PATIENT WEIGHT Not Used TIME UNITS min BRAL mg min Conc 20 mg mL gt Press NEXT to Confirm NEXT 40 PROGRAMMING Syringe Module 8110 Series Direction for Use Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued e f hospital facility practice guidelines identify selected Eon a drug as weight based prompt for a patient weight in 10000 units kilograms appears as in illustrated example which 50 mL reflects use of Heparin in Pediatrics ICU g Uis hour NOTE Once a patient weight is entered for any biso units kg h module it is automatically entered for any subsequent Cone 200 units mL weight based calculation ree ever 5 Verify parameters are correct and press NEXT soft key to a ca confirm CONTINUOUS INFUSION mh NOTE If the ALL Mode is enabled VTBI ALL displays ALL roe mg min Conc 20 mg mL gt Select Rate or Dose SETUP BOLUS 79 oO G D gt z G 6 To make arate or dose entry press applicable soft key EUIS Wa RATE or DOSE and use numeric data entry keys other CONTINUOUS INFUSION value is calculated and displayed mb mi aa mg min
87. sthesia Mode is disabled while a Syringe Module is paused the Syringe Module remains in an indefinite pause until the module is restarted When Anesthesia Mode is enabled e All Guardrails Limits are set to Soft e Dose checking mode is set to Smart e Key press audio is turned off e Tamper Resist Mode panel locked is not available All Guardrails Drug Library entries are available for selection Bolus dose is automatically available for drugs in Guardrails Drug Library that have bolus dose limits defined and generic drug calculation setup regardless of system configuration settings Anesthesia Mode alternating with other required prompts displays in prompt bar of Main Display Callback audio for paused modules is permanently silenced Review of drug calculation setup page is omitted when restoring a stopped drug calculation Enabling Anesthesia Mode 1 From Main Display press OPTIONS key 2 Press Anesthesia Mode soft key CAUTION When the Medley System is set up for use in Anesthesia Mode it is important to select the profile that corresponds with the care area the patient will be taken to when the Anesthesia Mode is discontinued This ensures that the Medley oystem will be in the correct profile following the use of the Anesthesia Mode System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Se
88. sure sensing disc is installed correctly Press CHANNEL SELECT key Press OPTIONS key w N EY infusion Setup 60 mL h 40 mL gt Press START PAUSE KETE START WARNING 10 Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient 32 PROGRAMMING Syringe Module 8110 Series Direction for Use Basic Infusion Continued Selecting Pressure Limit Continued Pressure Sensing Disc Installed Continued 4 Press Pressure Limit soft key V5 channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit 550 mmHg Prime Set with Syringe Channel Labels gt Select an Option or EXIT 5 To enter a new pressure limit value press Change Value A soft key Pressure Limit Selection Current pressure U OR 30 mmHg Z If Auto Pressure feature is enabled press Auto Pressure Current limit T soft key _ 550 mmig ie NOTE If Auto Pressure is selected and current pressure is 2 CONFIRM 0 e 100 mmHg or less system adds 30 mmHg to current pressure to create a new alarm limit e greater than 100 mmHg system adds 30 to current pressure to create a new alarm limit 6 Verify correct pressure limit input and press CONFIRM soft key Pressure Sensing Disc Not Installed 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Pressure Limit soft key FQ C
89. t supported in Multidose Mode Delay for option when scheduling a callback is not available in Multidose Mode e Maximum allowable delay on a multidose infusion is 8 hours Programming with Volume Duration Enabled If Volume Duration was enabled at the time the Medley System was configured for use use the following procedure to program a multidose infusion 1 Perform steps in Start Up section to a Power on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 68 PROGRAMMING Syringe Module 8110 Series Direction for Use Multidose Mode Continued Programming with Volume Duration Enabled Continued 2 Perform steps in Preparing Infusion section to a Prepare syringe and administration set b Load syringe and administration set c Select syringe type and size and Basic Infusion as infusion type d Prime 3 Press OPTIONS key 4 Press Multidose soft key FY channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit 550 mmHg Prime Set with Syringe Channel Labels gt Select an Option or EXIT EXIT 79 oO Q 79 gt Z Q 5 If Current time displayed is correct press CONFIRM soft LY multidose key otherwise press Change Time and enter correct Time of Day time Reference Setting Up Time of Day procedure in Current t
90. tatus Indicator illuminates After 2 minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes 2 Toreinitiate infusion Midtown Hospital Press RESTART key on Syringe Module By PASSER OR Continued on Next Page Syringe Module 8110 Series Direction for Use 30 PROGRAMMING Basic Infusion Continued Pausing Infusion Continued Press CHANNEL SELECT key and then press START soft key on Point of Care Unit Restarting Infusion Following Infusion Complete If syringe requires replacement reference Preparing Infusion section in Getting Started chapter to a Remove existing syringe and prepare new syringe reference Preparing Infusion Preparing Syringe and Administration Set section in Getting Started chapter b Load syringe and administration set c Select syringe type and size NOTE Since the system is already in a basic infusion mode the Infusion Menu screen does not appear after the syringe type and size are confirmed d Prime FY vac 50 mL 50 mL h ALL gt Press START VOLUME PAUSE VOLUME START To restart infusion using stored parameters press RESTORE soft key and continue with next step OR To start a new infusion follow steps for Starting Rate Volume Infusion or Starting Volume Duration Infusion PN intusion Setup
91. the Point of Care DFU ener a CUNT 0 D ln The Medley Syringe Module is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected It is a positive displacement delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice including resistances to flow imposed by small gauge catheters filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions G m G T gt A ar m O 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 facility personnel must ensure the performance of the common IV site is satisfactory under these circumstances Each time the Medley System 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 operate within the desired occlusion detection parameter s Syringe Module 8110 Series GETTING STARTED 9 Direction for Use Warnings and Cautions Continued Guardrails Safety Software CUI AAA The Guardrails
92. through alphabet and or PAGE UP and PAGE DOWN soft keys e The facility may choose to to prepopulate standard drug concentrations or leave an open entry mL and allow the clinician to enter the desired concentration Aber Guarde Drug Library Aminophylline 50mg 50mL A E Bretylium 50 mg 25mL F J Dobutamine mg mL K O Dopamine 40mg 50mL P T Dopamine 8mg 25mL U Z gt Select Drug Concentration DRUG PAGE EXIT CALC DOWN 4 To continue programming press Yes soft key e Bolus dose units appear if Bolus Dose is enabled OR To change selection press No soft key e f Yes was selected and facility has defined a Clinical Advisory for that drug a message appears To indicate information has been noted and continue programming press CONFIRM soft key e f Yes was selected to continue programming drug amount and diluent volume if defined in Guardrails Drug Library are automatically entered for selected drug e fselected drug had mL concentration drug amount and diluent volume need to be entered e f selected drug is not weight based Not Used displays in PATIENT WEIGHT field as in illustrated example Continued on Next Page EARS Wa AE Drug Library Yes 2 gram 250mL was selected No Is this correct DOSING uns mg min BOLUSABLE BOLUS posne mg kg UNITS gt Press Yes or No Guardrail
93. tion Limits Limits specified for the range of concentrations allowed for a particular drug in a profile Delay Options The Delay Options feature allows the system to be programmed to delay the start of an infusion a for up to 120 minutes or b for a specific time up to 23 hours 59 minutes A callback for a programmed delay can be scheduled to give an alert Before an infusion is to be initiated After an infusion is completed Before and After an infusion or no alert None Syringe Module 8110 Series INTRODUCTION 3 Direction for Use Features and Definitions Continued Drug Calculation Dynamic Pressure Display Event Logging Fast Start Guardrails Drug Library Guardrails Limit Multidose Mode The Drug Calculation mode allows e entry of drug dose Medley System calculates correct flow rate to achieve desired dose OR e entry of flow rate Medley System calculates corresponding drug dose The Dynamic Pressure Display appears on the Main Display If enabled it graphically displays the current patient side occlusion pressure set point and the current patient side operating pressure for that module Reference Displays section in Getting Started chapter for additional Dynamic Pressure Display information Event Logging records instrument operations When Fast Start is enabled and an administration set having a pressure sensing disc is used the instrument runs at an increased rate when an

Alaris Medley Syringe Module 8110 Version 7

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