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1. GETTING STARTED 21 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 mE until it lines up with syringe te c Gently release clamp against syringe ipid o 0 9 a R amp 8 e Syringe Barrel Clamp Closed 5 Lower drive head and lock plunger in place with plunger Gripper Control in grippers Closed Position N a Twist gripper control clockwise and hold in position Drive Head Flush ND i NA NOTE The gripper control is spring loaded When A blange Ren 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 L n lower drive head until it makes contact with plunger EN flange amm CAUTIONS To avoid 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 c Gently release gripper control d Ensure plunger grippers lock and hold plunger in place For smaller syringes such as 1 3 or 5 cc stabilize the syri
2. 99 APPENDIX TRUMPET AND START UP CURVES sssssssssssssssssssssss Ie e sss e e ee a e 3 e e an plns 101 ii TABLE OF CONTENTS GENERAL CONTACT INFORMATION Customer Advocacy For clinical and technical questions feedback and troubleshooting assistance Phone toll free within the United States and Canada 800 854 7128 Ext 7812 E Mail CustomerFeedback alarismed com Technical Support For technical information related to maintenance procedures and service manual support United States Canada Phone Phone Toll free 858 458 6003 Eastern 800 908 9918 Toll free 800 854 7128 Ext 6003 Western 800 908 9919 For more detailed information refer to the Service Information section of this document THIS PAGE INTENTIONALLY LEFT BLANK About the System INTRODUCTION out the System a The Medley Medication Safety System is a modular infusion and monitoring system intended for use in today s growing professional healthcare environment for use in adult pediatric and neonatal care The Medley Medication Safety System consists of the Programming Module 8000 Series the Guardrails Safety Software and up to four detachable modules or channels which provide infusion or monitoring capabilities NOTE The Medley Programming Module name will be changing in the near future to Medley Point of Care Unit The Medley Syringe
3. 7 To return to main screen press EXIT soft key Al f EXIT soft key is pressed before pressure sensing disc is Ke rei Prassure Seieing i e ISC reinstalled a prompt to reinstall pressure sensing disc displays gt Press CONFIRM Gy CONFIRM d Z 6 e f Basic Infusion was selected Infusion Setup screen LY infusion Setup 4 displays and title alternates between Infusion Setup and RATE mL h E identifying syringe model and size VTBI ALL m gt Select RATE f Guardrails Drug Library was selected Guardrails Drug N Feri Library Library screen displays Aminophyline 50mg 50mL A E Bretylium 50 mg 25mL FAI Dobutamine mg mL K O Dopamine 40mg 50mL P T Dopamine 8mg 25mL U Z gt Select Drug Concentration DRUG PAGE EXIT CALC DOWN Pressure Sensing Disc Not Used Installed 1 Press OPTIONS key 2 Press Prime Set with Syringe soft key LN 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 GETTING STARTED 29 Preparing Infusion Continued Priming Continued Pressure Sensing Disc Not Used Installed Continued 3 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 So
4. 3 Verify parameters are valid and press START soft key EX vac 50 mL RATE 50 mL h NOTE To change a restored parameter viBI ALL 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 Press START PAUSE Rens START GETTING STARTED 37 Basic Infusion Continued Changing Rate or VTBI During Infusion 1 Press CHANNEL SELECT key 2 Press either RATE or VTBI soft key LY infusion Setup RATE 50 mL h vrB 40mL gt Press START Pause vous 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 f no other channel is active the system powers down when the CHANNEL OFF key is released e To interrupt the power down sequence quickly press any one of the numeric keys on the Programming Module Selecting Pressure Limit Pressure Sensing Disc Installed 1 Ensure pressure sensing disc is installed correctly 2 Press CHANNEL SELECT key 3 Press OPTIONS key LY infusion Setup _60 mL h VTBI 40 mL gt Press START PAUSE E S
5. clamp V gt Press CONFIRM CONFIRM Response Check Syringe Drive Not Engaged Plunger grippers opened during infusion and then closed Infusion stops on affected channel Syringe barrel clamp opened during infusion and then closed Infusion stops on affected channel Syringe plunger not captured while in idle state System alarms after 30 seconds to indicate potential siphoning condition Drive system disengaged during operation gt gt gt 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 90 ALARMS ERRORS MESSAGES Errors Error Meaning Response Channel Error Syringe Calibration Required Syringe Driver Head Error Error detected Operation stops on affected channel Error on infusing channel indicating calibration is required Infusion stops on affected channel CALIBRATE scrolls in Channel Message Display Noninfusing channel with plunger grippers open senses excessive pressure being applied downward on Drive Head OCCLUSION scrolls in Channel Message Display To silence alarm and continue oper
6. mL h Start Up Curve at 5 mL h initial 1 g mL 20 40 60 80 100 120 0 20 Time min Trumpet Curve at 1 mL h initial 40 60 80 100 120 Time min Trumpet Curve at 5 mL h initial Flow Rate Error Flow Rate Error a a t ica je ii t 145 dla 10 15 20 25 30 0 Observation Interval min M 10 15 20 25 30 Observation Interval min Legend WB Maximum rate error Overall rate error Minimum rate error 102 APPENDIX ALARIS MEDICAL SYSTEMS ALARIS Medical Systems Inc 10221 Wateridge Circle San Diego California 92121 U S A Mail P O Box 85335 San Diego California 92186 5335 U S A ALARIS ALARIS Medical Systems Guardrails and Medley are trademarks and registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective owners US Pat Nos 5 601 445 5 713 856 5 836 910 5 941 846 AU Patent Nos 693 662 703 178 703 203 728 366 TW Patent No NI 107963 Other Patents Pending 147967 003 Copyright 2003 ALARIS Medical Systems Inc All Rights Reserved
7. 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 ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION lt 2 Z m z gt Q m See packing inserts for international warranty if applicable MAINTENANCE 99 THIS PAGE INTENTIONALLY LEFT BLANK 100 MAINTENANCE APPENDIX Trumpet and Start Up Curves Trumpet and Start Up Curves In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual syringes and adminis
8. gt Select RATE VOLUME DURATION 2 Toenter a numeric VTBI value instead of infusing ALL press VTBI soft key and use numeric data entry keys OR To deliver entire contents of syringe leave VTBI as ALL NOTE When ALL MODE is disabled the VTBI ALL option is not available EH Attach administration set to patient s vascular access device EN intusion Setup 40 mL h VTBI ALL gt Press START PAUSE EE START A Verify correct infusion parameter entry and press START soft key NOTE The infusion may be paused by pressing the PAUSE soft key Refer to Pausing Infusion section e During infusion Green Infusing Status Indicator illuminates Rate appears in Channel Rate Display Remaining VTBI appears on Main Display When infusion is close to being completed and NEOI is enabled Main Display alternates between NEAR END and remaining VTBI NEAR END scrolls in Channel Message Display Yellow Standby Indicator flashes An audio prompt sounds Continued on Next Page Midtown Hospital Adult ICU A VIBI ALL 50 mL VOLUME AUDIO INFUSED ADJUST 32 GETTING STARTED Starting Volume Duration Infusion li Basic Infusion Continued Starting Rate Volume Infusion Continued At completion of infusion An audio prompt sounds Red Alarm Status Indicator flashes If KVO op
9. 40 GETTING STARTED 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 An audio prompt sounds to silence press SILENCE key Red Alarm Status Indicator flashes CHECK SYRINGE scrolls in Channel Message Display 3 Remove syringe and separate administration set from syringe O 4 Reattach administration set to new syringe refer to Preparing Infusion section gt A 5 Load new syringe refer to Preparing Infusion section a gt 6 Select syringe type and size refer to Preparing Infusion section 0 7 Press CONFIRM soft key 8 Prime administration set refer to Preparing Infusion section 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 GETTING STARTED 41 Channel Labels Selecting Channel Label 1 Press CHANNEL SELECT key 2 Press OPTIONS key w Press Channel Labels soft key L channe Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit High Prime Set with Syringe Channel Labels gt Select an Option or EXIT A Press soft key for desired label NOTE To view additional labels press a soft key next to a letter group to navigate through
10. Respond as indicated above for both Before and After A F E 17 Pausing Infusion zx 1 Press DELAY OPTIONS soft key E vac 50 mL 40 mL h VTBI ALL gt Press START OP TNs DURAN START 2 Press Pause soft key EX Delay Options 09 30 Pause NOTES Delay for Using the Pause function in the Delay Options screen is the Delay until same as pressing the PAUSE key on the Syringe Module ACK e The time displayed in the upper right corner of the screen is the time of day in a 24 hour clock format military time gt Select a Delay Option Ez 3 Press CONFIRM soft key Delay Options 09 30 Pause PAUSE scrolls in Channel Message Display Delay for e PAUSED appears on Main Display Delay until Yellow Standby Status Indicator illuminates E 3 After two minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Press CONFIRM Indicator flashes GETTING STARTED 77 Delay Options Continued Pausing Infusion Continued 4 To reinitiate infusion EY vac 50 mL RATE 40 mL h Press RESTART key or Ai OR Press CHANNEL SELECT key and then START soft key gt Press START DELAY oes DURATION START Multidose Mode NOTES WARNINGS Since by definition a multidose infusion will not be infusing for The Multidose feature is to be a programmed period of time it is assumed that another used only by person nel properly infusing IV lin
11. 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 System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT EXIT Bonn 68 GETTING STARTED Anesthesia Mode Continued Enabling Anesthesia Mode Continued 3 Press Enable soft key System Options Anesthesia Mode 4 Press CONFIRM soft key Disable Pump Module Change Air Detection S 75 microliters gt Select an Option or Press CONFIRM CONFIRM 5 Press Channel Select key Midtown Hospital 6 Program Anesthesia Mode infusion using same procedure as for any other continuous infusion E Qt a m a a a v 2 A m w Anesthesia Mode VOLUME AUDIO INFUSED ADJUST Disabling Anesthesia Mode The Anesthesia Mode can be disabled and normal operation resumed using either of the following three 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
12. m iw To ensure proper performance of the Medley System and to reduce potential injury observe the following precautions Epidural Administration WARNING The Medley System can be used for epidural administration Epidural administration of drugs of anesthetic and analgesic drugs This application is only other than those indicated for appropriate when using analgesics and anesthetics labeled epidural use could result in serious for continuous epidural administration and catheters injury to the patient intended specifically for epidural use Use only standard single use disposable syringes with luer lock connectors WARNING and administration sets designed for use on syringe pumps M eden A a Pump It is strongly recommended that the and without a Y connector or injection port for epidural oe syringe administration set and IRIS Syringe Module used for epidural Epidural administration of anesthetic drugs Use drug delivery be clearly differentiated indwelling catheters specifically indicated for short term from those used for other types of 96 hours or less anesthetic epidural drug delivery administration Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery GETTING STARTED 9 Warnings and Cautions Continued WARN NG This instrument is designed to stop fluid flow unde
13. Continued on Next Page Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 muh viBi 50 mL DOSE 9 mg min Conc 20 mg mL gt Press START PAUSE SETUP BOLUS START Ly Guardrails Drug Library Lidocaine Dose exceeds Yes Guardrail limit of 8 mg min No Proceed gt Press Yes or No 48 GETTING STARTED Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued r 2 p Guardrails Drug Library NOTE Ifthe programmed continuous dose infusion is outside LA fee the Guardrails Hard Limit for that care area a prompt cea Sr d reprogram appears before programming can continue The infusion limit of 8 mg min needs to be reprogrammed gt Press REPROGRAM e During infusion Midtown Flospital Green Infusing Status Indicator illuminates A VTB 50mL Rate appears in Channel Rate Display Dose and drug name scroll in Channel Message Display a m a a e v 2 A m O NOTE lf a dose outside of the Guardrails Soft Limits has been entered and verified as correct the Channel auno Message Display also shows either LLL for a low dose or 111 for a high dose Main Display alternates between VTBI and drug name with dose When infusion is close to being completed and NEOI is enabled Main Display alternates betw
14. 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 When using a 10cc or smaller syringe only the syringe size and type specified on the Main Display The ALARIS Medical Systems strongly full list of permitted syringe models is dependent on the Syringe recommends using an extension set Module s software version with a pressure disc for improved pressure monitoring and shorter times to occlusion alarm Manufacturer 1cc 3cc 5cc 6cc 10cc 12cc 20cc 30cc 35cc 50cc 60cc gt AstraZeneca x1 x m B D Plastipak x x x x x x x x IVAC x e Monoject X x x x x x Terumo x x3 x3 x x x x 1 Prefilled Diprivan 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 MAINTENANCE 97 Refer to the Medley Programming Module Directions for Use Inspection Requirements To ensure the system remains in good operating condition both regular and periodic inspections are required Regular inspections consist of a visual inspection for damage WARNING and cleanliness and performing the procedure described in the Failure to perform these inspections Start Up section of this Directions for Use before each usage may result in improper instrument of the instrument Regular inspections must b
15. Main Display alternates between NEAR END and remaining VTBI NEAR END scrolls in Channel Message Display Yellow Standby Indicator flashes a m l a e v 2 A m w An audio prompt sounds e At completion of infusion Midtown Hospital e An audio prompt sounds A COMPLETE Red Alarm Status Indicator flashes If KVO option is enabled Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO followed by SYRINGE EMPTY appears on Main Display If KVO option is disabled and Syringe is not empty INFUSION COMPLETE scrolls in Channel Message Display and COMPLETE appears on Main Display Syringe is empty SYRINGE EMPTY scrolls in Channel Message Display and appears on Main Display VOLUME AUDIO INFUSED ADJUST GETTING STARTED 55 Programming 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 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 The bolus VTBI cannot exceed the programmed continuous infusion VTBI Programming and starting a bolus dose deletes any programmed delay f no continuous rate is entered
16. Syringe Module administration sets are supplied with a sterile fluid path for one time use Do not resterilize Fluid path is STERILE and NONPYROGENIC Discard if packaging is not intact or protector caps are unattached For administration set replacement interval refer to facility protocol and or government standards such as CDC guidelines in the United States e For IV push medication put instrument on hold clamp tubing above the port Flush port s per facility protocol Discard administration set per facility protocol 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 refer to the Compatible Syringes section in the Maintenance chapter For a list of compatible administration sets refer to the Set Compatibility Card provided separately GETTING STARTED 13 a m a a e v 2 A m w Warnings and Cautions Continued User Precautions Continued 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 the ECG monitoring system is not functi
17. 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 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 a m a a e v 2 A m w Specifying by Minutes The Delay for option is used to program an infusion delay for a minimum of one minute and up to 120 minutes 1 Press DELAY OPTIONS soft key EX vc 50 mL 40 mL viBl ALL gt Press START DELAY VOLUME CRA DRAN START 2 Press Delay for soft key Delay Options 08 00 Pause Delay for Delay until gt Select a Delay Option GETTING STARTED 71 Delay Options Continued Delaying Infusion Continued Specifying by Minutes Continued 3 Toenter number of minutes up to 120 infusion is to be delayed for use numeric data entry keys A Delay Options
18. 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 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 3096 to current pressure to create a new alarm limit When a bolus is delivered the pressure alarm limits are temporarily raised to the maximum limit The system automatically detects the syringe size and narrows down the syringe selection list 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 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 The Channel Labels feature is available when the Profiles feature is enabled It provides a hospital defined list of labels displayed in the Channel Message Display and identifying the channel with the solution being infused the catheter location or other helpful information The Delay Options feature allows the system to be programmed to delay the start of an infusion a for up to 120 minut
19. Housing A Pressure JS Sensing Disc j a Patient Side c Apply firm upward pressure on pressure sensing disc not tubing until disc snaps into place Pressure Sensing Disc GETTING STARTED 23 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 bh 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 syringes refer to the Compatible Syringes section in the Maintenance chapter If the installed syringe is displayed and selected but is not recognized servicing is required refer to Service Information section in Maintenance chapter 1 Midtown Hospital Adult ICU A gt Select Channel VOLUME AUDIO INFUSED ADJUST 2 Press soft key next to installed syringe type and size Selection is highlighted Syr
20. KVO Selection Range Occlusion Alarm Thresholds Without Pressure Sensing Disc With Pressure Sensing Disc Operating Principle Flow Rate Range mL h Syringe Size mL 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 IPX1 Drip Proof Approximately 800 mmHg NOTE On a high setting the actual occlusion pressure will vary based on the syringe size and manufacturer 1060 mmHg 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 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 Three settings Low Medium High User selected from 25 to 1000 mmHg in 1 mmHg increments Positive displacement 94 MAINTENANCE Specifications Continued Rate Accuracy Rate accuracy of the Medley Syringe Module is 2 of full scale plunger travel not including syringe variation WARN NG D A3 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 Refer to Trumpet and Start
21. 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 acceptable routes of administration such as intravenous IV intra arterial IA subcutaneous epidural enteral or irrigation of fluid spaces zZ J fe J c CO d fe zZ Guardrails Safety Software for the Medley System brings a new level of medication error prevention to the point of patient care The Guardrails Safety Software features medication dosing guidelines for up to ten patient specific care areas referred to as profiles Each profile contains a specific drug library and channel labels as well as instrument configurations appropriate for the care area Optional drug specific Guardrails Clinical Advisories provide visual messages Dosing limits for each drug entry may be either Guardrails Hard Limits that cannot be overridden during infusion programming or Guardrails Soft Limits that can be overridden based on clinical requirements A data set is developed and approved by the facility s own multi disciplinary team using the Guardrails Editor the PC based authoring tool A data set is then electronically transferred to the Medley System by qualified personnel The approved data sets are maintained by the Guardrails Editor for future updates and reference Information about Guardrails Alerts th
22. Module and attached modules Manufacturing Date Number adjacent to symbol indicates the month and year of manufacture Consult operating instructions CAUTION Federal U S A law restricts this device to sale by or on the order of a physician Single Use Do not re use Product contains a particular element such as DEHP in fluid pathway Product DOES NOT contain a particular element such as administration set is latex free Approximate administration set priming volume Expiration date for product will be identified near hour glass symbol Do not use if package is damaged INTRODUCTION 7 zZ J fe J c CO d fe zZ THIS PAGE INTENTIONALLY LEFT BLANK 8 INTRODUCTION GETTING STARTED NOTE Although the Medley Medication Safety System is built R Only and tested to exacting specifications it is not intended to replace the supervision of IV infusions by medical personnel The user should become thoroughly familiar with the features and operation of the Medley System and exercise vigilance in its utilization GUGM A warning is an alert to potential serious outcomes death injury or serious adverse events to the patient or user CAUTION A caution is an alert to take special care for the safe and effective use of the device Warnings and Cautions For WARNINGS and CAUTIONS for the Programming Module refer to its Directions for Use e m a a e v 2 A
23. Press OPTIONS key 4 Press Multidose soft key LN 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 f Current time displayed is correct press CONFIRM soft key EY Muttidose otherwise press Change Time and enter correct time Time of Day Reference Setting Up Time of Day procedure in Medley Current time Change Programming Module Directions for Use NOTE lf the current time has been previously confirmed the Time of Day screen will not be displayed gt CONFIRM Time of Day CONFIRM 6 Press VOLUME DURATION soft key LQ Multidose 08 00 ____ mUh gt Enter Rate VOLUME DURATION GETTING STARTED 79 a m a a e v 2 A x m iw Multidose Mode Continued Programming with Volume Duration Enabled Continued 7 To enter volume to be infused for each dose use numeric data entry keys A Multidose 08 00 RATE mL h VOLUME DOSE mL DURA TION 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 Al Multidose 08 00 RATE mL h 10 mL CE min gt Enter Duration RATE vaike 9 To enter time interval 1 to 24 hours between doses press DOSE INTERVAL soft key a
24. and weight if used are entered bolus VTBI and concentration conc alternate in the Main Display 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 A Drug Calculation BOLUS DOSE mcg ca E 2000 mcg kg mg mg kg Conc 5000 mcg mL gt Select the Desired Dosing Units SETUP 62 GETTING STARTED Programming Bolus Dose Continued Using Non Library Drug Calculation Continued To enter bolus duration use numeric data entry keys FEY Drug Calculation BOLUS DOSE OR 2000 meg To deliver bolus dose at maximum rate possible for selected PATIENT Not Used 99 mum profile and setup and automatically calculate bolus CENE in xm duration press Max Rate soft key TOTAL DOSE 2000 mg Conc 5000 mcg mL TOTAL DOSE alternates with INFUSE AT rate gt Enter Duration SETUP O i n Verify parameters are correct and press START soft key oru Calculation m A BOLUS DOSE z During infusion O f Dose 2000 meg 7 Green Infusing Status Indicator illuminates PATIENT Not Used eonun x f j M J e Rate appears in Channel Rate Display DURATION lt 1 min J NFUSE AT gt 9999 mcg min o e Dose scrolls in Channel Message
25. and yellow Standby Status Indicator flashes EY vac so mL RATE 50 mL h vei ALL gt Press START VOLUME PAUSE EET START 2 Toreinitiate infusion Press RESTART key on Syringe Module OR Press CHANNEL SELECT key and then press START soft key on Programming Module Midtown Hospital Adult ICU A PAUSED VOLUME AUDIO INFUSED ADJUST Ey vac 50 mL 50 mL h VTBI ALL gt Press START VOLUME PAUSE ers START 36 GETTING STARTED Basic Infusion Continued Restarting Infusion Following Infusion Complete 1 If syringe requires replacement reference Preparing Infusion section to a Remove existing syringe and prepare new syringe reference Preparing Syringe and Administration Set section b Load syringe and administration set c Select syringe type and size NOTE Since the system is already in a basic infusion Gy mode the Infusion Menu screen does not appear after Ex the syringe type and size are confirmed z A d Prime v a 2 To restart infusion using stored parameters press RESTORE LY infusion Setup mi soft key and continue with next step RATE mL h S VIBI ALL OR To start a new infusion follow steps for Starting Rate Volume Infusion or Starting Volume Duration Infusion gt Select Rate or Restore Previous Infusion VOLUME eeN
26. ri treten EE hated bant 77 MULMIDOSE MODE E 78 Programming with Volume Duration Enabled 0 0 0 0 000 00 78 Programming with Volume Duration Disabled sss 82 REVIEWING SERIAL NUMBER bees loea tenerent e ted btt ecu ahead iiie ege 85 REVIEWING SOFTWARE VERSION esce eee eee Rp E REPE d rhet dg 85 ALARMS ERRORS MESSAGES DEFINITIONS qM 87 AUDIO CHARACTERISTICS rte ete rione Ete e tenta ti Ent aaa ER enna someon ceanh Ed 88 ALARMS EET 89 Syringe Adjustment Alarms iiissssssssssssssssssssssssssssssss s sss ss sae pn n e n n nnn 90 ERRORS EMMRT 91 MESSAGES p ER x 91 MAINTENANCE SPECIFICATIONS A 93 CONFIGURABLE SETTINGS ssssusuuuuussssssssssssss sss eh eee se 3 ea a p 3 nons 96 Systemi Settiigs useceeeer eir p e nEDERC RR YRUERAR E eorr Man OE RERBA N nl pie geass gigs 96 Shared Infusion Settings Pump Module and Syringe Module o aasa 96 Syringe Module Settings n anaana aa 97 COMPATIBLE SYRIINGES er nacet s X Neige d RT E EPI dae tity E AI E CES NE TR ae E EAEE 97 Scc E 98 INSPECTION REQUIREMENTS 22 rettet rtt RETI E EF eert ania E Sce pret RISO SS ER rerteest 28s 98 SERVICE INFORMATION 3 reb bbb dedi teret eee bete debt iterato tpi cope idee ead 98 QU DamT
27. sensing disc is not the Guardrails Drug Library go to the Setting Up Drug being used and an occlusion occurs Calculation section there is a risk of infusing pressurized buildup of infusates upon correction NOTES of the occlusion To avoid an The illustrations in this section assume the following inadvertent bolus relieve the pressure ALL Mode Drug Calculation Dynamic Pressure Display Profiles before restarting the infusion and Volume Duration configurable settings are enabled Delay Options and NEOI configurable settings are disabled If Delay Options is enabled the PAUSE soft key becomes DELAY OPTIONS 1 Perform steps in Start Up section to a Power on system b Choose Yes or No to New Patient a m a a e v 2 A m iw 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 GETTING STARTED 31 Basic Infusion Continued Starting Rate Volume Infusion 1 To enter flow rate press RATE soft key and use numeric data entry keys Al Infusion Setup mL h ALL
28. to allow delivery of multiple equal doses from the same syringe at regularly scheduled intervals 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 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 To simplify programming the Restore feature can be used to recall previous rate and volume settings for the same patient This optio
29. windows may be of interest when certain drugs are being administered Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug being infused and on the degree of intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered The start up curves represent continuous flow rate versus operating time for two hours from the start of the infusion 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 Syringe Module typically exhibits a long term accuracy offset of approximately 0 296 or less from the mean value NOTE Tests conducted in accordance with IEC EN 60601 2 24 Particular requirements for safety of infusion pumps and controllers and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers using B D Plastipak 60cc Syringe and ALARIS Medical Systems Administration Set 30910 APPENDIX 101 gt ze a m zZ 9 X 2 0 Trumpet and Start Up Curves Continued Start Up Curve at 1 mL h initial 1 g mL 1 8 1 6 14 1 2 S 1 0 5 08 0 6 0 4 0 2 0 0 0 2
30. 08 00 Pause PeeWee minutes Delay until gt Enter Delay Time 1 120 min BACK 4 Press CONFIRM soft key Delay period counts down on Main Display f a Before callback has not been scheduled reference Scheduling a Callback section infusion automatically initiates at end of delay period Delay Options 08 00 Pause yAEWaied _ 20 minutes Delay until _ sack None gt Select Callback or Press CONFIRM Midtown Hospital 7 Adult ICU 08 00 A Start in 20 min VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU 09 00 A VTBI ALL 50 mL VOLUME AUDIO INFUSED ADJUST 72 GETTING STARTED Delay Options Continued Delaying Infusion Continued Specifying by Time of Day The Delay until option is used to program an infusion delay for a N vac 50 mL minimum of one minute and up to 23 hours 59 minutes 40 muh VTBI ALL 1 Press DELAY OPTIONS soft key gt Press START O FERAE start m 6 2 Press Delay until soft key Delay Options 08 00 UA Pause Delay for a m Delay until iw gt Select a Delay Option 3 f Current time displayed is correct press CONFIRM soft key EY Delayed Options otherwise press Change Time and enter correct time Time of Day Reference Setting Up Time of Day procedure
31. ALARIS MEDICAL SYSTEMS Medication Safety System Syringe Module Model 8110 Directions for Use 0LLS8 13Q0 lN 310GOIN ADNIYAS TABLE OF CONTENTS INTRODUCTION ABOUT THE SYSTEMI etre ette ohele soto om Droite nt esos temere duMh a 1 FEATURES AND DEFINITIONS rette rtp RE ERE EE IRR py sean ERA E Ree rt epis 3 Odo E eA a Ere E LENA REAN E EAE EEEE E A EE A E EEEE 7 GETTING STARTED WARNINGS AND CAUTIONS 222 20222 sce panes rebote eot madd Pea PII MERI aenaran iaie ragian 9 CONTROLS AND INDICATORS oa sess e e ee e 3 e 3 e s np 3 anon 16 INSTALLATION EE 17 Unpacking Synge Module cote teet tte shes pde tens E Redes aid dae Vd dupedt edt td 17 ATTACHING AND DETACHING CHANNELS ssssssssssssssssss sss e e e el een 17 DISPLAYS 22 c 18 Malm DISPLAY ACETUM 18 Dynamic Pressure Display 2 0 0 0 0 19 SUUM L 19 Powering On Systerm cecus oot Rr e det Rape ppt dae rails debated ite ta eb aree anne of 19 Responding to Maintenance Reminder 000 0 e ees 19 Selecting New Patient and Profile Options isssssssssssssssssssssss e ee teeeeeees 19 Entering Patient ID ci tenerse dete niorum open dd ESPERA Hen Rhen EIEEE E EEEE rH HL INR o 19 Moditying Patent ID escas deret tet A o uie pue debes cde bane dae de ded bales 19 PREPARING INFUSIO
32. DURATION SETUP OR e When continuous dose is weight based a Press SETUP soft key LA cearda Drug Library Heparin BOLUS DOSE ca EN 50 unit kg went 10 kg TOTAL DOSE 500 units Conc 200 units mL gt Select DURATION Continued on Next Page 58 GETTING STARTED Programming Bolus Dose Continued Using ECTVE Tro e T M Drug Library Calculation Continued b Press PATIENT WEIGHT soft key LA EE calidad aru 10000 units 50 mL 10 kg UNITS Hour BOSING units kg h Conc 200 units mL gt Press NEXT to Confirm DRUG NEXT c To change patient weight use numeric data entry oon Drug Library keys 10000 units vawe 50 mL __ 1w UNITS Hour BOSING units kg h Conc 200 units mL gt Press NEXT to Confirm DRUG LIBRARY NEXT P i 5 A F Guardrails Drug Library NOTE Ifa continuous infusion is running a prompt Al Heparin to confirm the weight change appears eae Adjust Dose or Rate if required Accept weight change d Press NEXT soft key a m a a e v 2 A x m iw Yes No gt Select Yes or No e Press BOLUS soft key A Esap Prus Doray CONTINUOUS INFUSION RATE 0 83 mL h VB 50 mL DOSE 15 unitkgih Conc 200 units mL gt Press START Pause setup BoLus START Continued on N
33. Display Conc 5000 meg mL Ba Press START to Begi e Bolus VTBI counts down on Main Display rasina Bolus DOR When continuous infusion is close to being PAUSE SETUP onus START completed and NEOI is enabled Midtown Hospital Main Display alternates between NEAR END and Adult ICU remaining VTBI A BOLUS VTBI 0 4 mL NEAR END scrolls in Channel Message Display Yellow Standby Indicator flashes An audio prompt sounds VOLUME AUDIO INFUSED ADJUST NOTE To see details during the bolus infusion press the 3o Calculation CHANNEL SELECT key BOLUS DOSE Dose Remaining 2000 mcg Pt Weight Not Used 999 mL h Time Left lt 4 min Mar TOTAL DOSE 2000 mcg BOLUS VTBI 0 4 mL gt Press START to Continue Infusing Bolus Dose STOP Pause STOR START Continued on Next Page GETTING STARTED 63 Programming Bolus Dose Continued Using Non Library Drug Calculation Continued At completion of bolus infusion System beeps twice BOLUS DOSE COMPLETE scrolls in Channel Message Display NOTE If the bolus dose infusion is not followed immediately by a continuous dose infusion BOLUS COMPLETE appears on the Main Display Continuous dose infusion if programmed initiates VTBI counts down on Main Display At completion of continuous infusion An audio prompt sounds Red Alarm Status Indicator flashes If KVO option is enabled Rate Displ
34. Mode gt Select an Option or EXIT EXIT B N GETTING STARTED 69 Anesthesia Mode Continued Disabling Anesthesia Mode Continued From System Options Menu Continued 3 Press Disable soft key 4 Press CONFIRM soft key Anesthesia Mode no longer appears on Main Display indicating it has been disabled Disconnecting System from AC Power While in Anesthesia Mode 1 Disconnect system from AC Anesthesia Mode is automatically disabled All currently running infusions continue A prompt 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 To continue using Anesthesia Mode press Yes soft key OR To discontinue Anesthesia Mode press No soft key System Options Anesthesia Mode Enable Disable Pump Module Change Air Detection 75 microliters gt Select an Option or Press CONFIRM CONFIRM Anesthesia mode was discontinued when AC power cord was disconnected Press CONFIRM to continue normal operation CONFIRM AC power cord was connected Continue ANESTHESIA MODE No Yes gt Select Yes or No 70 GETTING STARTED Delay Options Delay Options can be enabled at the time the Medley System is configured for use
35. N tac tit trt rentrer Pape nage S Ret ur pEE De Ue PRI TRRS SO PEPPPH IIS 20 Preparing Syringe and Administration Set sss 20 Loading Syringe and Administration Set sss 20 Selecting Syringe Type and Size sssisisssssssssssssssssssssss I nnn 24 PILI INS cir tetera cet A E E A A 26 BASIC INFUSION icc bcr ebore bd Ea sect biden n E EE Ce addee ant eevee end 31 Starting Rate Volume Infusion ssssssssssssssssssssssssss I n e nnne 32 Starting Volume Duration Infusion issssssssssssssssssssss e e eee 33 Possible End of Infusion Messages and Alerts 2 0 0 0 e 35 Pasing MEUSI REENEE 36 Restarting Infusion Following Infusion Complete 0 0 0 0 37 Changing Rate or VTBI During Infusion usao e 38 STOPPING INFUSION nd ihidade cope sr tee vas dd db eee epe tote cadant d dba died i penc 38 Selecting Pressure Limit iiiiiiisissssssssssssssssssssss sss ss e s e s n 3 s p n nini 38 Viewing and Clearing Volume Infused ssssssssssssssssssssssss e ene 40 Changing Syringe During Infusion aaao EEEE e e een 41 CHANNELLEABELS ip Eta det s agi wt eed LUN ENS pe SOR ETUR D E bep M HIS 42 Selecting Channel Label 5 5 tire e rtp e RARE EDGE RARE ONE ERVE eA LAXE Ra ARE 42 Removing Channel Label eoram euntis SEE ewes ET m Rd URDU PU Tau FUTURORUM SOS 43 POWERING OFF MT 43 Powering Off System 220 0 43 Powering Ott Channel eoo ects vaduoneetasyd apens E et M bat Vehden
36. Potential hazards include drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms GUGM Do not use the Medley System in close proximity of Magnetic Resonance Imaging MRI 10 GETTING STARTED Warnings and Cautions Continued VARNIM C 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 refer to the Compatible Syringes section in the Maintenance chapter For a list of compatible administration sets refer to the Set Compatibility Card provided separately GUGM 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 KLUB 2 D 69 amp w 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 relieve the pressure before restarting the infusion GUI When priming Ensure patient is not connected Ensure air is expelled from
37. SETUP ous START GETTING STARTED 67 Anesthesia Mode When the Medley System is operating in Anesthesia Mode a CAUTION channel can be paused indefinitely without an alarm When the Medley System is set u Anesthesia Mode also makes it possible to have additional drugs i for use in Anesthesia Mode it is in each profile which are only accessible when operating in important to select the profile that Anesthesia Mode corresponds with the care area the patient will be taken to when the NOTE When the Anesthesia Mode is disabled while a Pump Anesthesia Mode is discontinued Module is paused the Pump Module remains in an indefinite This ensures that the Medley System pause until the module is restarted will be in the correct profile following When Anesthesia Mode is enabled the use of the Anesthesia Mode All Guardrails Limits are set to Soft Dose checking mode is set to Smart Key press audio is turned off Tamper Resist Mode panel locked is not available All Guardrails Drug Library entries are available for selection Bolus dose is automatically available for e 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 channels is permanently silenced
38. T 1 gram vawe DO mL went Not Used UNITS min RN e mg min Conc 20 mg mL gt Press NEXT to Confirm NEXT 46 GETTING STARTED Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued e f hospital practice guidelines identify selected drug as weight based prompt for a patient weight in kilograms appears as in illustrated example which reflects use of Heparin in Pediatrics ICU NOTE Once a patient weight is entered for any module it is automatically entered for any subsequent weight based calculation Guardrails Drug Library Heparin DRUG 10000 units vawe 50 mL PATIENT WEIGHT kg TIME UNITS hour DOSING i pas units kg h Conc 200 units mL gt Enter Patient Weight NEXT Verify parameters are correct and press NEXT soft key to confirm I NOTE If the ALL Mode is enabled VTBI ALL displays Guardrails Drug Library Lidocaine CONTINUOUS INFUSION RATE mL h VTBI ALL DOSE mg min Conc 20 mg mL gt Select Rate or Dose SETUP Bous To make a rate or dose entry press applicable soft key RATE or DOSE and use numeric data entry keys other value is calculated and displayed Guardrails Drug Library Lidocaine CONTINUOUS INFUSION RATE ___mL h VTBI me DOSE _ ___ mg min Conc 20 mg mL gt Select Rate or Dose SETUP BOLUS To enter volum
39. TART WARNING 9 Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient 38 GETTING STARTED Basic Infusion Continued Selecting Pressure Limit Continued Pressure Sensing Disc Installed Continued 4 Press Pressure Limit soft key LQ 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 A d 6 5 To enter a new pressure limit value press Change Value soft A vs key Pressure Limit Selection Current pressure a OR 30 mmHg o If Auto Pressure feature is enabled press Auto Pressure soft Current limit key _ 550 mmHg Bionic NOTE If Auto Pressure is selected and current pressure is 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 EQ 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 GETTING STARTED 39 Basic Infusion Continu
40. 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 AND 55 h D 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 can occur in the event of a single fault condition will not exceed 296 of nominal syringe fill volume during loading and 196 of maximum syringe travel after syringe loading Dimensions 4 5 W x 15 0 H x 7 5 D Environmental Conditions Operating Storage Transport Temperature Range 41 to 104 F 4 to 140 F g 5 to 40 C 20 to 60 C gt e gt Relative Humidity 20 to 90 5 to 85 Z Avoid prolonged exposure Noncondensing Noncondensing to relative humidity gt 85 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 Programming Module must remain in an upright position MAINTENANCE 93 Flow Rate Programming Specifications Continued 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 Fluid Ingress Protection Infusion Pressure Maximum Without Pressure Sensing Disc With Pressure Sensing Disc KVO Keep Vein Open Rate
41. Up Curves section in Appendix chapter for data on how these factors influence rate accuracy Shock Protection Type CF Defibrillator Proof Time to Alarm Maximum Pressure Limit Rate mL h No Disc With Disc Highest High 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 9096 Temperature 68 4 Volume to be Infused Programming Increments Range mL Increments mL 0 1 9 99 0 01 10 60 0 1 Weight 4 5 lbs lt 2 Z m z gt Q m NOTE Compliance to Standards The Medley Medication Safety System has been assessed and complies with the following standards UL 2601 1 including A1 and A2 CSA C22 2 No 601 1 including A1 and A2 IEC EN 60601 2 24 IEC EN 60601 1 2 and AAMI ID26 MAINTENANCE 95 Configurable Settings If the configuration settings need to be changed from the Factory Default settings refer to 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 pra
42. alphabet and or PAGE UP and PAGE DOWN soft keys Selected label is highlighted and scrolls in Channel Message Display A Channel Label Display Adult ICU 0 9 NaCl A E 3 NaCl F J CVVHDF Dialysate K O D5 1 2 NS P T Epidural U Z gt Select Channel Label PAGE EXIT DOWN Channel Label Display Adult ICU Peripherial Art Line P Replacement Solution Q Swan R Triple Lumen S T gt Select Channel Label PAGE PAGE UP BACK Al 5 To continue infusion press START soft key OR Program infusion as previously described LY infusion Setup 50 mL h 40 mL gt Press START Pause gout START 42 GETTING STARTED Channel Labels Continued Removing Channel Label 1 Press CHANNEL SELECT key 2 Press OPTIONS key w Press Channel Labels soft key L 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 A Press CLEAR LABEL soft key A ESSI fade Display Adult ICU 0 9 NaCl A E a m a a e v 2 A x m iw Label stops scrolling in Channel Message Display 3 NaCl F J CVVHDF Dialysate K O D5 1 2 NS P T Epidural U Z gt Select Channel Label CLEAR PAGE EXIT Eei DOWN 5 To b
43. at occur during use is stored within the Medley Programming Module and can be accessed using the Guardrails Continuous Quality Improvement CQ Event Tracker and Guardrails CQI Event Reporter INTRODUCTION 1 About the System Continued This document provides directions for use for the Medley Syringe Module Read all instructions for both the Syringe Module and Programming Module before using the Medley System 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 refer to the directions for use provided with the set For set priming and loading instructions refer to the Preparing Infusion section in the Getting Started chapter of this document Contraindications None known 2 INTRODUCTION Features and Definitions Refer to the Alarms Errors Messages chapter of this Directions for Use for the definitions of various alerts Refer to the Medley Programming Module Directions for Use for system features and definitions ALL Mode Auto Pressure Auto Pressure Limit Adjustment Auto Syringe Size Identification Back Off Bolus Dose Channel Labels Delay Options When ALL is selected as the volume to be infused VTBI the entire contents of the syringe will be delivered When enabled and a pressure sensing disc is in use the
44. atient 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 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 Bolus dose duration Bolus VTBI Bolus rate Bolus dose VTBI Bolus dose Drug concentration Bolus rate Bolus VTBI Duration Continued on Next Page KZXTTB 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 44 GETTING STARTED Setting Up Drug Calculation Continued Drug Calculation Parameters Continued Continuous drug dose Flow rate x Drug concentration normalized for patient weight if specified by entering a patient weight Continuous flow rate Drug dose Drug concentration normalized for patient weight if specified by entering a patient weight Drug concentra
45. ation of unaffected channels press CONFIRM soft key Replace channel with an operational instrument as required Service by qualified personnel is required To silence alarm and continue operation of unaffected channels press CONFIRM soft key Replace channel with an operational instrument as required Service by qualified personnel is required To silence alarm and continue normal operation press CONFIRM soft key UESELE Message Meaning Response After Call Back 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 Channel running in continuous infusion mode if programmed Delay time completed Current infusion completed Programmed volume to be infused delivered channel running at KVO rate Syringe almost empty 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 see Configurable Settings section ALARMS ERRORS MESSAGES 91 gt S zm Dn e uet C rg m JI Ne pe u Messages Continued Message Meaning Response Panel Locked Panel Unlocked Pa
46. ay changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO followed by SYRINGE EMPTY appears on Main Display If KVO option is disabled and Syringe is not empty INFUSION COMPLETE scrolls in Channel Message Display and COMPLETE appears on Main Display Syringe is empty SYRINGE EMPTY scrolls in Channel Message Display and appears on Main Display 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 64 GETTING STARTED Programming Bolus Dose Continued Stopping Bolus Dose Continued 2 Press STOP BOLUS soft key aE d dd BOLUS DOSE Dose Remaining 5 mg kg Pt Weight 71 kg 999 mL h Time Left 2 min Max TOTAL DOSE 355 mg BOLUS VTBI 17 8 mL gt Press START to Continue Infusing Bolus Dose STOP Pause Sos START 3 To stop bolus and start continuous infusion press Yes soft EN cuadras Drug Library key Stop Bolus and Start Yes Continuous infusion No e m a a e v 2 A m iw gt Press Yes or No 4 To stop continuous infusion press and hold CHANNEL OFF Midtown Hospital key until a beep is hear
47. ctice 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 Refer to the Medley Programming Module Directions for Use Shared Infusion Settings Pump Module 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 Bolus Dose Disabled Enabled Disabled Multidose Disabled Enabled Disabled Callback None None Before After Before and After NEOI Disabled Enabled Disabled Alert Time 60 1 60 minutes or 2596 of remaining infusion time whichever comes later Pressure Dynamic Disabled Enabled Disabled Dynamic Pressure Display Priming Disabled Enabled Disabled Volume Duration Disabled Enabled Disabled 96 MAINTENANCE 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 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 With Disc 1000 mmHg 25 1000 mmHg in 1 mmHg increments
48. d approximately 1 5 seconds A VTBI 50 mL VOLUME AUDIO INFUSED ADJUST Restoring Bolus Dose A bolus dose can be restored after it has completed either prior to or after the channel has been turned off as indicated in the following sections NOTE The display examples in this section represent restoring a bolus dose which was programmed 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 GETTING STARTED 65 Programming Bolus Dose Continued Restoring Bolus Dose Continued Bolus Dose Completed Channel Not Turned Off 1 Press CHANNEL SELECT key 2 Verify infusion parameters and press BOLUS soft key Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 mUh viBi 50 mL DOSE 9 mg min Conc 20 mg mL gt Press START PAUSE sETUP BOLUS START 3 Press RESTORE soft key Ly Guardrails Drug Library Lidocaine BOLUS DOSE pos _ _ _ mg kg mat Tia Conc 20 mg mL gt Enter Bolus Dose RESTORE SETUP 4 Verify dosing parameters and press START soft key Bolus Dose Completed Channel Turned Off 1 Press CHANNEL SELECT key 2 Press RESTORE soft key Lidocaine BOLUS DOSE DOSE 5 mg kg PATIENT WEIGHT 71 kg 999 mL h DURATION 2 min INFUSE AT 333
49. d all doses in the DOSES multidose program must be completed within a 24 hour program GETTING STARTED 83 Multidose Mode Continued Programming with Volume Duration Disabled Continued 9 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 NEO is enabled the Near End of infusion message appears near the end of the last dose A Multidose 08 00 RATE 20 mL h 10 mL DOSE INTERVAL every 06 n 0F _ 4 doses gt Press START PAUSE START Midtown Hospital z AduiCU 08 00 A VTBI 10 mL VOLUME AUDIO INFUSED ADJUST Midtown Hospital i AdutiCU 02 30 AQ MULTIDOSE COMPLETE VOLUME AUDIO INFUSED ADJUST 10 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 oun 10 mL ose every 06 h x 04 doses Doses completed 0 Volume remaining 7 mL gt Press START PAUSE START 84 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Disabled Continued e Between infusions Multidose 0535 Number of doses completed and when next dose dia mL h starts displays
50. ded 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 26 GETTING STARTED Bg DM Preparing Infusion Continued Priming Continued Press OPTIONS key Press Prime Set with Syringe soft key LN 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 A EXIT m L 4 a i z f pressure sensing disc was not removed prior to A A ressing Prim ith Syringe soft key a pressur v P e g T Set wit Sy ge B ey E It is recommended that the sensing disc removal prompt displays Pressure Sensing Disc be 2 removed during priming Press CONFIRM and o continue priming gt Press CONFIRM CONFIRM 4 Prime as follows a Orient pressure sensing disc with patient side up E zZ AA sez b Depress and hold pressure sensing disc between two Patient Side oS g fingers E Pressure Sensing Disc V ES 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 depemlest connected to patient NOTE Fluid is delivered during priming only wh
51. e performed by operation the hospital facility and if any damage is found service is required REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Exterior Surfaces Each usage Keypad Each usage Mechanical Parts Each usage CLEANING As required START UP Each usage Exterior Surfaces examine for overall condition and verify e No damage cracks or deformities Caseis clean and free from IV solution residue especially near moving parts e Labels and markings are legible No tape or other foreign material is on sides of case anything of this nature could prevent proper latching of channels UI Connectors have not been damaged 2 Keypad Check membrane switches for damage 3 Mechanical Parts Ensure mechanical parts move freely do not hang up or bind and function properly Periodic inspections of the hardware are required For detailed CAUTION instructions on performing periodic inspections and Periodic inspections should only be maintenance refer to the Medley Technical service Manual performed by qualified service and supplemental service bulletins and Medley Maintenance personnel Software User Manual Service Information Refer to the Medley Programming Module Directions for Use 98 MAINTENANCE WARRANTY ALARIS Medical Systems Inc hereinafter referred to as ALARIS Medical Systems warrants that A Each new ALARIS Medical Systems Medley Syringe Module
52. e to be infused press VTBI soft key and use numeric data entry keys NOTE The BOLUS soft key appears only if Bolus Dose is enabled within the selected profile the drug is bolusable and a VTBI is entered Continued on Next Page Guardrails Drug Library Lidocaine CONTINUOUS INFUSION RATE 27 0 mL h ml ca _ __9 mg min Conc 20 mg mL gt Select VTBI SETUP BOLUS GETTING STARTED 47 e m a e v 2 pel m iw Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued NOTE When VTBI equals ALL the ALL soft key appears inactive when the VTBI soft key is pressed and active when a value is entered Guardrails Drug Library Lidocaine CONTINUOUS INFUSION RATE 27 0 muh ALL ALL DOSE 9 mg min Conc 20 mg mL gt Enter VTBI PAUSE setuP BoLus staRT Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 0 mun Mem 50m ALL DOSE 9 mg min Conc 20 mg mL gt Press START PAUSE SETUP BOLUS START 8 Verify parameters are correct and press START soft key NOTE If the programmed continuous dose infusion is outside the Guardrails Soft Limit for that care area a prompt appears before programming can continue If the Yes soft key is pressed programming continues if the No soft key is pressed the infusion needs to be reprogrammed
53. e will keep the vein open until the beginning of trained in using multidose the first dose and between subsequent doses There is no keep infusions ji KVO infusion at th letion of d i qu usion at the completion of a programme a Caution labels cwhidhiclea dy differentiate single dose and ALL Mode is not supported in Multidose Mode multidose containers must be The Delay Options function for multidose infusions is similar to utilized Delay Options for continuous drug infusions with the following differences 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 78 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Enabled Continued 2 Perform steps in Preparing Infusion section to 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
54. ed Selecting Pressure Limit Continued Pressure Sensing Disc Not Installed Continued 4 To select a pressure limit press appropriate soft key Low Med or High 5 Press CONFIRM soft key Viewing and Clearing Volume Infused 1 To view volume infused press VOLUME INFUSED soft key Total volume infused and time and date volume infused was last cleared display for each channel NOTES Date format is year month day e Ifa Pump Module is attached a PRI SEC VOLUME soft key is available to allow secondary volume infused to be displayed e f no key is pressed main screen appears after 30 seconds Pressure Limit Selection Low High CONFIRM Midtown Hospital Adult ICU A VTBI ALL 42 5 mL B VTB ALL 48 1 mL VOLUME AUDIO INFUSED ADJUST 2 To clear volume infused NOTE If no key is pressed main screen appears after 30 seconds e f only selected channels are to be cleared press soft key next to applicable channel s and press CLEAR CHANNEL soft key e Volume clears on selected channel s f all channels are to be cleared press CLEAR ALL soft key To return to main screen press MAIN SCREEN soft key Volume Infused TOTAL VOLUME mL CLEARED A 42 5 Kilen B 48 1 sio gt Select Channels to Clear or Press CLEAR ALL CLEAR MAIN ALL SCREEN
55. ed the Near End of infusion message appears near the end of the last dose VOLUME AUDIO INFUSED ADJUST 12 To see detail screen during or between infusions press Mulitidose 08 10 CHANNEL SELECT key Rate 20 mth Volume _ During infusion Volume Remaining displays Dose 10 mL Duration 00 n 30 min every 06 h x 04 doses Doses completed 0 Volume remaining T7 mL gt Press START PAUSE START Continued on Next Page GETTING STARTED 81 Multidose Mode Continued Programming with Volume Duration Enabled Continued e Between infusions Number of doses completed and when next dose starts display Yellow Standby Status Indicator illuminates 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 A Multidose 08 35 Rate 20 mL h Yolumel 10 m Duration 00 n 30 min every 06 h x 04 doses Doses completed 1 Dose 2 Starts 14 00 gt Press START PAUSE START 2 Perform steps in Preparing Infusion section to Prepare syringe and administration se
56. eel anaes 43 SETTING UP DRUG CALCULATION sssssssssssssssII e s e s s n e lens 44 Drug calculation Parameters os eie berto toon Seres bacio dle ose secas d ed adu ue NR 44 Using Guardralls Drg BIDESly s secrete et Eee petto Co b ge EE tae bete to t RP UI eve o TER ks 45 Using onm Fierro PiU PRETEREA 50 TABLE OF CONTENTS i gt S zm mis ae as m JI Ne JIJ u NOILDNGOYLNI GALYVLS ONILLAD JDNVNALNIVIN XIGNAddV GETTING STARTED Continued PROGRAMMING BOLUS DOSE noaa esses e ee ea 3l e san plns 56 Using Guardrails Drug Library Calculation isssssssssssssssssssssss I 56 Using Non Library Drug Calculation ississssssssssssssssssssss nne 62 Stopping Bolus Dose issssssssssssssssssssssssssssssssssss sess sss essa ssa y e e e e p p n nnns 64 Restoring BOLUS DOSE picin cette eee redd be be apacanddddes vend Pa o bebe bid ned ead 65 ANESTHESIA MODBE 5b rro tes pxtett ete Fecit nre Rit r bed pM eR EEEE E IEE EE EES 68 Enabling Anesthesia ModE ee tote e T e POPE PO ubi Treo Donde eeu via peat a pu da 68 Disabling Anesthesia Mode iisssssssssssssssssssss e he e e e e ees 69 DELAY OPTIONS eaaet teet ttp nid oade E A E E ted duddeds ce cenobio ete etis nid 71 Delaying Inf SIOR u aoo cerent e dettes cedex tage hme Ru EEEE pe Martane da 71 Scheduling a Callback ssssssssssssssssssssssssssssss s ses es es e s e e s n nnn 75 PAUSING INFUSIO iki ed tee e YR Etpe e debo
57. een NEAR END and remaining VTBI NEAR END scrolls in Channel Message Display Yellow Standby Indicator flashes An audio prompt sounds At completion of infusion Midtown Hospital An audio prompt sounds A COMPLETE Red Alarm Status Indicator flashes If KVO option is enabled Rate Display changes to KVO rate INFUSION COMPLETE KVO with drug name scrolls in Channel Message Display KVO followed by SYRINGE EMPTY appears on Main Display VOLUME AUDIO INFUSED ADJUST Continued on Next Page GETTING STARTED 49 Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued If KVO option is disabled and Syringe is not empty INFUSION COMPLETE scrolls in Channel Message Display and COMPLETE appears on Main Display Syringe is empty SYRINGE EMPTY scrolls in Channel Message Display and appears on Main Display 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 the drug calculation must be programmed using the DRUG CALC soft key within the Guardrails Drug Library There are no Guardrails Limits associated with any non library drug calculation 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
58. efore option was selected An audio prompt sounds when delay period has ended Yellow Standby Status Indicator flashes DELAY COMPLETE scrolls in Channel Message Display and appears on Main Display f After option was selected An audio prompt sounds when delayed infusion completes and continues to sound until responded to Yellow Standby Status Indicator flashes until audio is silenced Infusion completed message appears on Main Display Infusion Complete scrolls in Channel Message Display f Before and After option was selected same prompts and indicators mentioned above for both Before and After options are exhibited Midtown Hospital F Adult ICU gt 08 00 A Start at 09 00 VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU 08 00 A Start in 20 min VOLUME AUDIO INFUSED ADJUST Midtown Hospital 7 Adult ICU 09 00 A DELAY COMPLETE VOLUME AUDIO INFUSED ADJUST The current infusion has completed gt Press CONFIRM CONFIRM 76 GETTING STARTED 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 e After callback Press CONFIRM soft key O e Before and After callback m
59. egin infusion press START soft key EY vac 50 mL RATE 50 mL h fvrBI ALL OR Program infusion as previously described gt Press START PAUSE ans START Powering Off Refer to the Medley Programming Module Directions for Use to the following procedures Powering Off System Powering Off Channel GETTING STARTED 43 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 Drug amount Amount of drug in IV container 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 p
60. ent including cabling and as such it is the responsibility of the hospital facility to ensure external equipment complies with the applicable EMC standards Failure to verify that external equipment meets applicable EMC standards may result in degraded electromagnetic compatibility refer to Radio Frequency Interference warning for additional information 14 GETTING STARTED Warnings and Cautions Continued User Precautions Continued Operating Environment 4 DANGER Not for use in the presence of flammable anesthetics Explosion risk if used in the presence of flammable anesthetics DANGER E e le e ne e me Ae e m EXPLOSION HAZARD J Z A Nn Radio Frequency Interference CZAD gt f a Operating the system near equipment which radiates high Use of accessories or cables other m energy radio frequencies electrosurgical cauterizing than those specified may result in z equipment portable radios cellular telephones etc may degraded electromagnetic cause false alarm conditions If this happens reposition the compatibility performance of this device away from the source of interference or turn off the device device and manually regulate the flow with the clamp and or monitor the vital parameters using an appropriate clinical alternative GETTING STARTED 15 Controls and Indicators Status Indicators Alarm Infusing Standby red green yellow Ws Chan
61. es 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 INTRODUCTION 3 zZ J fe J c CO d fe zZ Features and Definitions Continued Drug Calculation Dynamic Pressure Display Event Logging Fast Start Guardrails Clinical Advisory Guardrails Drug Library Guardrails Limit The Drug Calculation mode allows entry of drug dose Medley System calculates correct flow rate to achieve desired dose OR 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 infusion is first started taking up any slack in the drive mechanism A Guardrails Clinical Advisory is a visual message that appears when a designated drug is selected to remind a clinician of specific hospital standards of
62. essage pause SOP start isplay NOTE If the bolus dose infusion is not followed immediately by a continuous dose infusion BOLUS COMPLETE appears on the Main Display Continuous dose infusion if programmed initiates VTBI counts down on Main Display Continued on Next Page GETTING STARTED 61 Programming Bolus Dose Continued Using ECTVE Tro e T M Drug Library Calculation Continued e At completion of continuous infusion An audio prompt sounds Red Alarm Status Indicator flashes If KVO option is enabled Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO followed by SYRINGE EMPTY appears on Main Display If KVO option is disabled and Syringe is not empty INFUSION COMPLETE scrolls in Channel Message Display and COMPLETE appears on Main Display Syringe is empty SYRINGE EMPTY scrolls in Channel Message Display and appears on Main Display 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 DOSE is highlighted Ly Drug Calculation CONTINUOUS INFUSION 4 2 mL h 50 m pos 5 mcg kg min Conc 5000 mcg mL 2Press START pause sEruP BoLUs START 3 Toenter bolus dose use numeric data entry keys NOTE After a bolus dose
63. ext Page GETTING STARTED 59 Programming Bolus Dose Continued Using ECTVI Tro e T M Drug Library Calculation Continued f To enter bolus dose use numeric data entry keys Guardrails Drug Library Heparin BOLUS DOSE DosE _ _ _ __unit kg west 11kg DURATION Conc 200 units mL gt Enter Bolus Dose SETUP 5 Press DURATION soft key FAX csardrails Drug Library Lidocaine BOLUS DOSE 5 mgikg _ 71kg TOTAL DOSE 355 mg Conc 20 mg mL gt Select DURATION SETUP 6 To enter bolus duration use numeric data entry keys OR To deliver bolus dose at maximum rate possible for selected profile and setup and automatically calculate bolus duration press Max Rate soft key TOTAL DOSE alternates with INFUSE AT rate Guardrails Drug Library Lidocaine BOLUS DOSE DOSE 5 mg kg Wee dkg 99min ome En TOTAL DOSE 355 mg BOLUS VTBI 17 8 mL gt Enter Duration SETUP 7 Verify parameters are correct and press START soft key During infusion Green Infusing Status Indicator illuminates Rate appears in Channel Rate Display Dose and drug name scroll in Channel Message Display NOTE lf a continuous dose outside of the Guardrails Soft Limits has been entered and verified as correct the Channel Message Display also shows either LLL for a low dose or 111 for a high dose Conti
64. f 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 20 GETTING STARTED 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 ED until it clears syringe chamber lt ie c Gently release clamp Syringe Barrel Clamp Open 2 Raise drive head to its fully extended position Drive Head Fully Extended 1 Gripper Control Drive 7 Head Release in Open NOTE The gripper control is spring loaded When Boston ra twisted to the open position and then released it and the ZZ plunger grippers will return to the closed position Plunger Grippers Open b While holding gripper control in open position raise drive head to full extension a Twist gripper control clockwise and hold in position a m a a e v 2 pel m iw c Gently release gripper control 3 Insert syringe from front of instrument by sliding flat edge of syringe barrel flange between barrel flange grippers KD
65. ft key is pressed Each press of the PRIME soft key delivers up to 2 mL of priming fluid per continuous press To deliver additional amounts press the PRIME soft key again Volume used during priming is displayed but not added to VTBI Prime Set with Syringe CAUTION Do not prime with disposable set connected to patient Prime Volume Om gt Press and Hold PRIME EXIT 4 When priming is complete release PRIME soft key 5 To return to main screen press EXIT soft key f Basic Infusion was selected Infusion Setup screen displays and title alternates between Infusion Setup and identifying syringe model and size f Guardrails Drug Library was selected Guardrails Drug Library screen displays Prime Set with Syringe CAUTION Do not prime with disposable set connected to patient Prime Volume 2mL gt Press and Hold PRIME PRIME EXIT Al Infusion Setup RATE X mL h VTBI ALL gt Select RATE VOLUME DURATION Guardrails Drug Libra A Adult ICU li i 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 Lex Js 30 GETTING STARTED The following procedures should be used only when GUB programming a Basic Infusion To program an infusion using When the pressure
66. g mL gt Select PATIENT WEIGHT DRUG LIBRARY GETTING STARTED 51 a m a a e v 2 pel m iw Setting Up Drug Calculation Continued Using Non Library Drug Continued 8 To indicate whether or not patient weight is to be used in Drug Calculation press either Yes or No soft key NOTE Do not enter a patient weight if weight is not used in the calculation A Drug Calculation DRUG Ar 250 mg voume 50 mL Yes PATIENT E gt gt gt No 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 LIBRARY 9 To enter patient weight if required in kilograms use numeric data entry keys Al Drug Calculation DRUG amount 250 mg DILUENT Uoc 50 mL PATIENT fac kg TIME UNITS Di NG UNITS Conc 5000 mcg mL gt Enter Patient Weight DRUG LIBRARY 10 Press TIME UNITS soft key A Drug Calculation mount 250 mg vow DO mL 70k TIME UNITS UNI s Conc 5000 mcg mL gt Select TIME UNITS DRUG LIBRARY 11 To select time base for drug calculation press either Min Hour or Day soft key Al Drug Calculation DRUG amount 250 mg volu 50 mL weit 70 kg Min gt gt gt gt Hour DOSING Day Conc 5000 mcg mL g
67. hen 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 Q The default callback None or the callback for the current zi profile appears on the Main Display To schedule a different callback us gt 1 Prior to pressing CONFIRM soft key to initiate delay during EN Delay Options 08 00 zs Delay for or Delay until programming process press CALL Pause o BACK soft key Delay for _ 100 None gt Select Callback or Press CONFIRM 2 Press soft key corresponding to desired callback option E Delay Options 08 00 Scheduled callback appears on Main Display p Delay for Before Before Delay until 09 00 ang After CALL After gt gt gt gt gt gt None gt Select a Callback Option 3 To initiate delay press CONFIRM soft key EY Delay Options 08 00 Pause Delay for PAEWAI 09 00 Sisk After gt Select Callback or Press CONFIRM BACK CONFIRM Continued on Next Page GETTING STARTED 75 Delay Options Continued Scheduling a Callback Continued f Delay until programming time infusion is scheduled to start appears on Main Display f Delay for programming delay period counts down on Main Display f B
68. ile the PRIME soft key is pressed Each press of the PRIME soft key delivers 0 mt up to 2 mL of priming fluid per continuous press To deliver Press and Hold PRIME Prime Volume additional amounts press the PRIME soft key again PRIME EXIT e Volume used during priming is displayed but not added to VTBI GETTING STARTED 27 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 not prime with disposable set 6 connected to patient Prime Volume 2mL gt Press and Hold PRIME Prime EXIT 6 Reinstall pressure sensing disc as follows a Orient pressure sensing disc as follows fluid side up patient side down cavity forward membrane toward instrument Slot in Pressure b Gently slide pressure sensing disc up into slot in Sensing Disc pressure sensing disc housing Housing Pressure zs Sensing Disc j qu Patient Side c Apply firm upward pressure on pressure sensing disc L4 l not tubing until disc snaps into place Pressure Sensing Disc 28 GETTING STARTED Preparing Infusion Continued Priming Continued Pressure Sensing Disc Used Installed Continued
69. in Medley Current time Change Programming Module Directions for Use NOTE lf the current time has been previously confirmed the Time of Day screen will not be displayed gt CONFIRM Time of Day oneri 4 Toenter time of day infusion is to be initiated up to X Delay Options 08 00 23 hours 59 minutes use numeric data entry keys Pause Delay for PAE WA 2 gt Enter Delay Time GETTING STARTED 73 Delay Options Continued Delaying Infusion Continued Specifying by Time of Day Continued 5 Press CONFIRM soft key Time infusion is scheduled to start appears on Main Display f a Before callback has not been scheduled reference Scheduling a Callback section infusion automatically initiates at end of delay period EX Delay Options 08 00 Pause Delay for BIEN 9 00 sack None gt Select Callback or Press CONFIRM BACK CONFIRM Midtown Hospital y Adult ICU gt 08 00 A Start at 09 00 VOLUME AUDIO INFUSED ADJUST Midtown Hospital 7 Adult ICU 09 00 A VTBI ALL 50 mL VOLUME AUDIO INFUSED ADJUST 74 GETTING STARTED 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 three types of callback Before gives an alert w
70. inge Selection BD 50 mL IVAC 50 mL MONO 50 mL gt Select Syringe Size 24 GETTING STARTED Preparing Infusion Continued Selecting Syringe Type and Size Continued 3 To accept press CONFIRM soft key syringe Selection BD 50 mL IVAC 50 mL MONO 50 mL gt Confirm Syringe Size CONFIRM 4 Press soft key next to applicable infusion type Basic Infusion EY infusion Menu or Guardrails Drug Library Guardrails Drug Library Basic infusion NOTE The RESTORE soft key appears only if there had been a previous infusion programmed for the same patient a m a a a v 2 A m w gt Select an Option or EXIT RESTORE EXIT e f Basic Infusion was selected Infusion Setup screen ZY Infusion Setup displays and title alternates between Infusion Setup and RATE mL h identifying syringe model and size VIB ALL gt Select RATE f Guardrails Drug Library was selected Guardrails Drug Aire D9 Herav Library screen displays 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 GETTING STARTED 25 Preparing Infusion Continued The Priming option can be enabled at the time the Medley GUB System is configured for use The Priming select
71. ion PRIME soft When priming key is available only after the syringe and infusion type have mE been selected and prior to beginning an infusion Ensure patient is not connected If a pressure sensing disc is in use it must be removed from EC SHE alr is expelled Tm ne e prior to beginning infusion instrument before priming Refer to the applicable section as p i SUE unexpelled air in line could have follows depending on whether or not a pressure sensing disc is end serious consequences Failure to prime correctly can delay NOTE When manually priming per hospital protocol and an infusion delivery and cause the total administration set having a pressure sensing disc is in use depress volume to be infused to read higher the disc between two fingers while priming and prime uphill distal than the actual total delivered to the end of pressure sensing disc tubing pointing upward patient CAUTION During priming the pressure limit alarms are temporarily increased to their maximum level Pressure Sensing Disc Used Installed 1 Remove pressure sensing disc from instrument fef NURHLO N Using a finger apply firm downward pressure on The pressure sensing disc if left pressure sensing disc not tubing until disc snaps loose installed during priming can trap air from slot in pressure sensing disc housing that may not be totally expelled To ensure entrapped air is eliminated it is recommen
72. 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 of any ALARIS Medical Systems Product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and ALARIS Medical Systems shall not be responsible for any loss or damage arising in connection with the purchase or use of any ALARIS Medical Systems Product which has been
73. key Reattach channel if desired ensuring it is securely clicked into place at Channel Release Latch If alarm is still present replace channel with an operational instrument 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 Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key Press CONFIRM soft key and restart infusion Reinsert pressure sensing disc and press RESTART key Set up new infusion or press CHANNEL OFF key Verify appropriate pressure sensing disc is in use and functioning properly Verify syringe plunger movement is unimpeded If syringe is not empty and above actions do not correct alarm contact qualified service personnel ALARMS ERRORS MESSAGES 89 gt S zx Dri er ue C rg m JI Ne A u 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 When problem is corrected press CONFIRM soft key Alarm Meaning Syringe Installation 1 lever plunger flange clamp gt Check Syringe Syringe Installation V lever plunger flange
74. 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 VARNIM Ensure the syringe manufacturer and syringe size displayed matches the 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 refer to the Compatible Syringes section in the Maintenance chapter GETTING STARTED 11 e m Z a e v 2 A x m iw Warnings and Cautions Continued VARNIM C Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient VARNI N 2 0o 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 GUI 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 ma
75. llowed by SYRINGE EMPTY appears on Main Display If KVO option is disabled and Syringe is not empty INFUSION COMPLETE scrolls in Channel Message Display and COMPLETE appears on Main Display Syringe is empty SYRINGE EMPTY scrolls in Channel Message Display and appears on Main Display Possible End of Infusion Messages and Alerts e m a a e v 2 A x m iw KVO VTBI Delayed Programming Module Display Channel 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 umeric Yes Complete Infusion Complete Yes Yes if an After callback is scheduled N A umeric X Yes Syringe Empty Syringe Empty Yes Yes Off umeric No Complete Infusion Complete Yes Yes Off umeric No Syringe Empty Syringe Empty Yes Yes On umeric No Syringe Empty Syringe Empty Yes Yes GETTING STARTED 35 Basic Infusion Continued Pausing Infusion NOTE To pause an infusion when Delay Options is enabled reference Delay Options Pausing Infusion section 1 Press PAUSE key on Syringe Module OR Press CHANNEL SELECT key and then press PAUSE soft key on Programming Module e PAUSE scrolls in Channel Message Display e PAUSED appears on Main Display Yellow Standby Status Indicator illuminates After two minutes PAUSE RESTART CHANNEL visual and audio prompts begin
76. mg min Conc 20 mg mL Ly Guardrails Drug Library gt Press START to Begin Infusing Bolus Dose PAUSE SETUP Gcous START A Infusion Menu Guardrails Drug Library Basic infusion gt Select an Option or EXIT RESTORE EXIT 66 GETTING STARTED Programming Bolus Dose Continued Restoring Bolus Dose Continued Bolus Dose Completed Channel Turned Off Continued 3 Verify parameters and press NEXT soft key E Guaniails Drug Library Lidocaine DRUG AMOUNT 1 gram DILUENT VOLUME 50 mL PATIENT WEIGHT Not Used UNITS min Re mg min Conc 20 mg mL gt Press NEXT to Confirm Gy NEXT a z eS Nn 4 Verify infusion parameters and press BOLUS soft key Guardrails Drug Library x CONTINUOUS INFUSION zi 27 mUh iw v 50 mL DOSE 9 mg min Conc 20 mg mL gt Press START PAUSE SETUP BOLUS START 5 Press RESTORE soft key Ey Suztcrails Drug Library Lidocaine BOLUS DOSE Dose _ _ _ __ mg kg wee 71kg Conc 20 mg mL gt Enter Bolus Dose RESTORE SETUP Lidocaine BOLUS DOSE DOSE 5 mg kg WEIGHT 71 kg 999 mL h DURATION 2 min INFUSE AT 333 mg min Conc 20 mg mL gt Press START to Begin Infusing Bolus Dose 6 Verify dosing parameters and press START soft key ARE a PAUSE
77. n is only available if the patient is not new and the system is powered up within 8 hours of last usage INTRODUCTION 5 zZ J fe J c CO d fe zZ Features and Definitions Continued Selectable KVO Syringe Empty Syringe Volume Detection Volume Duration 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 The system automatically detects the fluid volume in a syringe when it is inserted 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 Symbols Ge MM YYYY Bu R Only Single Use OO Ex XX ml4 wa Canadian and U S Certification Mark Products bearing this mark have been tested and certified in accordance with applicable U S and Canadian electrical safety and performance standards CSA C22 2 No 601 1 UL 2601 1 and IEC 60601 2 24 Electrical Shock Protection Rating Type CF Defibrillation proof Protection against fluid ingress Drip Proof Attention Refer to accompanying documentation IUI Connector Inter Unit Interface connector used to establish power and communications between the Programming
78. nd use numeric data entry keys Al Multidose 08 00 RATE 20 mL h VOLUME DOSE 10 mL 30 hh mm DOSE INTERVAL gt Select DOSE INTERVAL RATE VOLUME 10 To enter number of doses press OF DOSES soft key and use numeric data entry keys f Delay Options is enabled DELAY OPTIONS soft key appears NOTE Reference Delay Options section 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 Al Multidose 08 00 RATE 20 mL h ose 10 mL Duration 00 h 30 min DOSE every_6h OF DOSES gt Select NUMBER OF DOSES RATE VOLUME 80 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Enabled Continued 11 To begin multidose infusion press START soft key E multidose 08 00 RATE 20 mL h ose 10 mL Duration 00 h 30 min DOSE INTERVAL every 06h EES _ 4 doses gt Press START PAUSE vB ae START Tn m G Main Display shows remaining VTBI for that dose Midtown eshte BB my E A VTBI 10 mL A e gt JI m le VOLUME AUDIO INFUSED ADJUST Atcompletion of a multidose program MULTIDOSE Midtown NETT COMPLETE appears on Main Display A MULTIDOSE COMPLETE NOTE If NEOI is enabl
79. nel Message Display Channel Identification Channel Select Key When pressed selects corresponding channel for infusion parameter entry and infusion setup Pause Key When pressed during an infusion temporarily stops d infusion on that channel After approximately 2 minutes a visual and audio prompt begins Channel Off Key When pressed and held until a beep is heard stops infusion on that channel deselects that channel and if only that channel had been operating system powers down Repeat for other operating channels to power off each channel Restart Key When pressed resumes operation of a previously paused or alarmed infusion on that channel Channel Release Latch IUI Connector Left AN m c Gripper Control Drive Head Release shown in closed position Plunger Grippers shown in closed position Barrel Flange Grippers Syringe Barrel Sensor IUI Connector Right Syringe Barrel Clamp Sizer Pressure Transducer Pressure Sensing Disc Housing 16 GETTING STARTED Installation Instruments are tested and calibrated before they are packaged for shipment To ensure proper operation after shipment it is recommended that an incoming inspection be performed before placing the instrument into use Unpacking Syringe Module 1 2 nd A LEN i N Remove Sy
80. nge 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 22 GETTING STARTED 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 avoid an Auto Pressure inadvertent bolus relieve the pressure Back Off Upon Occlusion before restarting the infusion Customizable Pressure Alarm Settings see Occlusion 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 Refer to the Features and Definitions section in the Introduction chapter for definitions a Orient pressure sensing disc as follows a m a a e v 2 A x m iw fluid side up patient side down cavity forward membrane toward instrument H b Gently slide pressure sensing disc up into slot in Slot in Pressure pressure sensing disc housing Sensing Disc
81. nician of specific hospital standards of practice when programming an IV medication A specific clinical advisory can be associated with a selected drug within any of the patient care profiles Maintenance Reminder A visual message that when enabled appears at module startup when scheduled preventive maintenance is due overdue for any part of the Medley System Programming Module or attached module gt S zm mis ue C rg m JI Ne pe u Prompt A visual message appearing on the bottom line of the Main Display or in the Channel Message Display The message may be accompanied by an audio signal that can be silenced for twelve seconds by pressing the SILENCE key ALARMS ERRORS MESSAGES 87 Audio Characteristics The Programming Module and Main Display provide various types of alert information The characteristics of the accompanying audio sounds are as follows Type Sound Notes Advisory Alarm Error Hardware Detected Error Software Detected Illegal Key Press Key Click Prompt Switchover One short beep every two seconds Choice of three alarm audio profiles selectable in System Configuration Pairs of long beeps Pairs of long beeps Two short beeps One short beep One short beep every two seconds Two short beeps bolus switching to continuous Variable volume can be silenced for two minutes Variable volume can be silenced for two minutes Fixed maximum decibel vol
82. nued on Next Page Guardrails Drug Library Lidocaine BOLUS DOSE post 5 mg kg d 71 kg 999 mL h DURATION 2 min INFUSE AT 333 mg min Conc 20 mg mL gt Press START to Begin Infusing Bolus Dose CONT PAUSE SETUP gous START 60 GETTING STARTED Programming Bolus Dose Continued Using ECTVI Tro e T M Drug Library Calculation Continued e Main Display alternates between Bolus VTBI and drug Midtown Hospital name with dose A BOLUS VTBI 17 8 mL e When continuous infusion is close to being completed and NEOI is enabled Main Display alternates between NEAR END and remaining VTBI NEAR END scrolls in Channel Message Display Yellow Standby Indicator flashes meses E An audio prompt sounds Midtown Hospital Adult ICU A Lidocaine 5 mg kg Bolus a m a a e v 2 A x m iw VOLUME AUDIO INFUSED ADJUST N Guardrails Drug Library Lidocaine NOTE To see details during the bolus infusion press the CHANNEL SELECT key The screen title alternates between BOLUS DOSE Guardrails Drug Library drug name and identifying Remaining Smgikg syringe model and size Pt Weight 71 kg oso mum Time Left 2 min Max At completion of bolus infusion TOTAL DOSE 355 mg BOLUS VTBI 17 8 mL System beeps twice gt Press START to Continue Infusing Bolus Dose ee DOSE COMPLETE scrolls in Channel M
83. oning 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 Dropping Jarring Should an instrument be dropped or severely jarred it should be immediately taken out of use and inspected by qualified service personnel to ensure its proper function prior to reuse Electromagnetic Compatibility EMC When using the Syringe Module in combination with a Programming Module which is interconnected to hospital data communications equipment 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 Compliance with the electromagnetic compatibility standard IEC 60601 1 2 is a function of all interconnected equipm
84. practice when programming an IV medication A specific clinical advisory can be associated with a selected drug within any of the patient care profiles 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 health system and entered into the system s data set 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 health system as either hard or soft limits e A Guardrails Hard Limit is a programmed limit that cannot be overridden e A Guardrails Soft Limit is a programmed limit that can be overridden 4 INTRODUCTION Features and Definitions Continued Multidose Mode Near End of Infusion NEOI Occlusion Pressure Pressure Sensing Disc Pressure Tracking Priming Restore 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
85. press VTBI soft key and use numeric data entry keys l NOTE The BOLUS soft key appears only if Bolus Dose is enabled within the selected profile and a VTBI is entered NOTE When VTBI equals ALL the ALL soft key appears inactive when the VTBI soft key is pressed and active when a value is entered Continued on Next Page Ly Drug Calculation CONTINUOUS INFUSION 4 2 muh ml L3 _ _ _ _5 meg kg min Conc 5000 mcg mL gt Select VTBI SETUP BOLUS Al Drug Calculation CONTINUOUS INFUSION RATE 4 2 mL h VB ALL DOSE 5 mcg kg min Conc 5000 mcg mL gt Press START PAUSE SETUP BOLUS START Ly Drug Calculation CONTINUOUS INFUSION RATE 4 2 mth 5O0m ALL Dose 5 mcg kg min Conc 5000 mcg mL gt Press START PAUSE SETUP BOLUS START 54 GETTING STARTED Setting Up Drug Calculation Continued Using Non Library Drug Continued 16 Verify parameters are correct and press START soft key EY Drug Calculation Durih cere CONTINUOUS INFUSION 9 i 4 2 muh Green Infusing Status Indicator illuminates 50 mL Rate appears in Channel Rate Display Dose 5 meg kg min e VTBI counts down on Main Display Conc 5000 mcg mL e Dose scrolls in Channel Message Display pee When infusion is close to being completed and NEOI Pause SETUP BOLUS START is enabled
86. r gt 6 Midtown Hospital Adult ICU Channel Selected Indicator T infusion Setup Inactive Soft Key _ 5 E 10mh Nonhighlighted indicates a 5 v ALL nonselected wie o C Active Soft Key A Highlighted indicates a selected soft key gt Press START Prompt Bar me ERE PAUSE RANN START Look here for user prompts 6666 18 GETTING STARTED Displays Continued Dynamic Pressure Display Midtown Hospital Adult ICU Dynamic Pressure Display Us Onc gt Current operating pressure Is indicated by solid bar Patient side occlusion pressure set point is indicated by tick mark wr E LJ EL Ee CAUTION 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 mmHg to 1000 mmHg a m a a e v 2 A x m iw Refer to the Medley Programming Module Directions for Use for the following procedures Powering On System Responding to Maintenance Reminder Selecting New Patient and Profile Options Entering Patient ID Modifying Patient ID GETTING STARTED 19 Preparing Infusion Preparing Syringe and Administra
87. r alarm conditions Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected WARN NG The Guardrails Safety Software incorporates dosing limits and instrument configuration parameters based on hospital protocol The software adds a test of reasonableness to drug programming based on the limits defined by the hospital Qualified personnel must ensure the appropriateness of the drug dosing limits the compatibility of the drugs and the performance of each instrument as part of the overall infusion Potential hazards include drug interactions and inappropriate delivery rates and pressure alarms GUGM 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 WARN NG 00000 The Medley Syringe Module 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 GUS Hospital facility personnel must ensure the compatibility of the drugs as well as the performance of each module as part of the overall infusion
88. ringe Module from its carton Verify gripper control drive head release plunger grippers and syringe barrel clamp sizer operate freely and correctly Verify pressure transducer membrane covering is not cut or torn Verify control surface and instrument housing is not damaged e m Z a e v 2 A x m iw Check for loose parts Perform Periodic Inspections see Inspection Requirements section in Maintenance chapter Perform check in procedure reference Medley Maintenance Software User Manual included with 8970C or later for details If the Syringe Module is damaged contact ALARIS Medical Systems for authorization to return the instrument for repair Attaching and Detaching Channels Refer to the Medley Programming Module Directions for Use GETTING STARTED 17 Displays The displays illustrated throughout this document are for illustration purposes only The display co depending on configuration settings typ ntent will vary e of syringe and administration set in use hospital defined data set uploaded using the Guardrails Safety Software programmed drug calculation parameters and many other variables DETTO PITT E Title Bar Channel Status Asolid channel letter display indicates channel is operating display indicates channel is attached and ready for use Soft Keys OL CULA VIB 250 0 mL G ANI An outlined channel lette
89. ry keys Rate is automatically calculated 4 Attach administration set to patient s vascular access device 5 Verify correct infusion parameter entry and press START soft EQWvac 50 mL key RATE 50 mL h VIBI ALL During infusion Green Infusing Status Indicator illuminates Rate appears in Channel Rate Display VTBI counts down on Main Display When infusion is close to being completed and NEOI is enabled Main Display alternates between NEAR END and remaining VTBI NEAR END scrolls in Channel Message Display Yellow Standby Indicator flashes An audio prompt sounds NOTE To view infusion Time Left press CHANNEL SELECT key To return to previous screen press START soft key Continued on Next Page E 1 00 hh mm gt Press START PAUSE Eo START Midtown Hospital Adult ICU A VTBI ALL 50 mL VOLUME AUDIO INFUSED ADJUST A Infusion Setup RATE 50 mL h VIBI ALL Time Left OO n 45 min 2Press START PAUSE ota START 34 GETTING STARTED Basic Infusion Continued Starting Volume Duration Infusion Continued At completion of infusion Midtown Hospital An audio prompt sounds A COMPLETE Red Alarm Status Indicator flashes e If KVO option is enabled Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display rm KA KVO fo
90. 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 Guardrails Drug Libra A Adult ICU i i 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 L EXIT CALC J DOWN 50 GETTING STARTED A Setting Up Drug Calculation Continued Using Non Library Drug Continued To enter DRUG AMOUNT in syringe use numeric data entry keys DRUG mcg EM on VS JILUEN r Al Drug Calculation gt Enter Amount of Drug in Container DRUG LIBRARY Press soft key for appropriate unit of measure for drug amount Al Drug Calculation Fem 250 mcg mg gram unit mEq gt Select Unit of Measure DRUG LIBRARY To enter diluent volume use numeric data entry keys Al Drug Calculation DRUG 250 mg DILUENT Wom mL gt Enter Diluent Volume DRUG LIBRARY Press PATIENT WEIGHT soft key Al Drug Calculation sour 250 mg 50 mL WEIGHT inte Conc 5000 mc
91. t 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 LN 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 82 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Disabled Continued 5 Toenter rate use numeric data entry keys LY Multidose 08 00 eae o gt Enter Rate 6 To enter volume to be infused for each dose press C Multidose 08 00 VOLUME DOSE soft key and use numeric data entry keys RATE 20 mh ml e m a a e v 2 A m O gt Enter Volume Dose 7 To enter time interval 1 to 24 hours between doses press EQ multidose 08 00 DOSE INTERVAL soft key and use numeric data entry keys RATE 20 mL h Piese 10 mL every __h gt Enter Dose Interval 8 To enter number of doses press OF DOSES soft key and use EQ Multidose 08 00 numeric data entry keys RATE 20 mL h f Delay Options is enabled DELAY OPTIONS soft key TUE appears aye Oh NOTE Reference Delay Options section to program an cess infusion delay When delaying an infusion a multidose cannot gt Select NUMBER OF be delayed for more than 8 hours an
92. t Select Time Units DRUG LIBRARY 52 GETTING STARTED Setting Up Drug Calculation Continued Using Non Library Drug Continued 12 Press soft key next to desired DOSING UNITS Boro Calculation DRUG amount 250 mg 50 mL 70 kg 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 Doro Calculation press NEXT soft key mount 250 mg DILUENT votume 50 mL weit 70 kg uns Min rg mcg kg min Conc 5000 mcg mL gt Press NEXT to Confirm DRUG LIBRARY NEXT NOTE If the ALL Mode is enabled VTBI ALL displays In the D oro Calculation following illustrated examples the ALL Mode is disabled CONTINUOUS INFUSION a m a a e v 2 A x m iw RATE ___mL h VTBI ALL Dose EE mcg 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 RATE EY drug Calculation or DOSE and use numeric data entry keys other value is CONTINUOUS INFUSION calculated and displayed RATE mh DOSE mcg kg min Conc 5000 mcg mL gt Select RATE or DOSE SETUP BOLUS GETTING STARTED 53 Setting Up Drug Calculation Continued Using Non Library Drug Continued 15 To enter volume to be infused
93. 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 Weight based example gt Continued on Next Page Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 27 mb h viBi 50 mL DOSE 9 mg min Conc 20 mg mL gt Press START PAUSE SETUP BOLUS START Guardrails Drug Library Heparin CONTINUOUS INFUSION 5 25 mun VB 50 mL DOSE 15 unit kg h Conc 200 units mL gt Press START PAUSE SETUP BOLUS START 56 GETTING STARTED Programming Bolus Dose Continued Using ECTVI Tro e T M Drug Library Calculation Continued e DOSE is highlighted NOTES e Ifthe programmed continuous dose infusion is outside the Guardrails Soft Limit for that care area a prompt appears before programming can continue If the Yes soft key is pressed programming continues if the No soft key is pressed the infusion needs to be reprogrammed e Ifthe 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 D be reprogrammed
94. tion Drug amount Diluent volume 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 rate or dose entry and VTBI entry if other than AII 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 GETTING STARTED 45 a m Z a e v 2 A x m iw Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued 3 Press soft key next to desired drug and concentration NOTES e To view additional drugs concentrations press a soft key next to a letter group to navigate through alphabet and or PAGE UP and PAGE DOWN soft keys 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 A G
95. tion Set 1 Prepare syringe reference Compatible Syringes section in Maintenance chapter in accordance with manufacturer s directions for use 2 Prepare administration set reference Set Compatibility Card provided separately in accordance with manufacturer s directions for use 3 Attach upper fitting of administration set to syringe tip Loading Syringe Ta To Administration Set WARNING A 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 refer to the Compatible Syringes section in the Maintenance chapter For a list of compatible administration sets refer to the Set Compatibility Card provided separately WARNINGS A e Before loading the syringe check it for damage or defects 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 occur when the administration set is not clamped or turned of
96. tion is enabled Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO followed by SYRINGE EMPTY appears on Main Display If KVO option is disabled and Syringe is not empty INFUSION COMPLETE scrolls in Channel Message Display and COMPLETE appears on Main Display Syringe is empty SYRINGE EMPTY scrolls in Channel Message Display and appears on Main Display Press VOLUME DURATION soft key Midtown Hospital Adult ICU A Kvo VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU A SYRINGE EMPTY VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU A COMPLETE VOLUME AUDIO INFUSED ADJUST Ly Infusion Setup RATE mL h VTBI ALL gt Select RATE VOLUME DURATION GETTING STARTED 33 a m a a e v 2 A x m iw Basic Infusion Continued Starting Volume Duration Infusion Continued 2 Toenter a numeric VTBI value instead of infusing ALL press LY infusion Setup VTBI soft key and use numeric data entry keys RATE mL h OR VIBI ALL DURATION 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 gt Select DURATION 3 To enter volume duration press DURATION soft key and use E numeric data ent
97. tolume 40 mt Yellow Standby Status Indicator illuminates every 06 h x 04 doses Doses completed 1 Dose 2 Starts 14 00 gt Press START PAUSE START Reviewing Serial Number Refer to the Medley Programming Module Directions for Use a m a a e v 2 A m iw Reviewing Software Version Refer to the Medley Programming Module Directions for Use GETTING STARTED 85 THIS PAGE INTENTIONALLY LEFT BLANK 86 GETTING STARTED 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 Advisory A sequence of audio and or visual signals indicating the operating status of the Medley Medication Safety System The audio may be silenced for approximately two minutes by pressing the SILENCE key Alarm An audio and visual signal that a potentially unsafe condition is present Immediate action is required The audio may be silenced for approximately two minutes by pressing the SILENCE key Error An audio and or visual signal that a failure has been detected Immediate action is required Guardrails Alert A visual message to help reduce programming errors by indicating a Guardrails Limit soft or hard has been exceeded A response is required before programming can continue Guardrails Clinical Advisory A visual message when a designated drug is selected to remind cli
98. tration 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 D 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 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
99. uardrails 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 4 To continue programming press Yes soft key Bolus dose units appear if Bolus Dose is enabled OR To change selection press No soft key 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 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 If selected 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 Guardrails Drug Library Adult ICU Lidocaine Yes 2 gram 250mL was selected No Is this correct DOSING units mg min BOLUSABLE BOLUS Dosa mg kg UNITS gt Press Yes or No Guardrails Drug Library Lidocaine Clinical Advisory Watch IV site carefully for signs of extravasation gt Press CONFIRM coner A Guardrails Drug Library Lidocaine AMOUN
100. ume cannot be silenced Fixed maximum decibel volume can be silenced for two minutes Variable volume cannot be silenced Fixed minimum volume can be silenced and disabled in System Configuration Variable volume can be silenced Variable volumes can be silenced and disabled in System Configuration 88 ALARMS ERRORS MESSAGES Alarms Alarm Meaning Response Channel Disconnected Check Syringe Occlusion Pressure Disc Installed Pressure Disc Removed Syringe Empty Channel s disconnected while in operation or have a communication problem Plunger grippers opened during gt infusion and then closed Infusion stops on affected channel Syringe barrel clamp opened gt during infusion and then closed Infusion stops on affected channel Syringe plunger not captured gt while in idle state System alarms after 30 seconds to indicate potential siphoning condition Increased back pressure sensed while infusing Infusion stops on affected channel Pressure sensing disc installed during an infusion Infusion stops on affected channel Pressure sensing disc removed Infusion stops on affected channel Syringe is empty gt If syringe is not empty other possibilities are Pressure sensing disc gt inappropriate defective e Syringe plunger travel impeded gt e Pressure transducer defective To silence alarm and clear message from screen press CONFIRM soft
101. use 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 If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of Programming Module 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 92 ALARMS ERRORS MESSAGES 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
102. y not operate within the desired occlusion detection parameter s G UGIN amp hh wh 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 Parallel Infusions There are no contraindications regarding the use of the Medley System with any other positive displacement infusion device when ported together into a common IV site location 12 GETTING STARTED Warnings and Cautions Continued User Precautions To ensure proper performance of the Medley System and to reduce potential injury to the operator observe the following precautions e Disconnect from main AC power when performing maintenance The instrument case should only be opened by qualified service personnel using proper grounding techniques Administration Sets and Syringes e Fora list of compatible syringes refer to Compatible Syringes section in Maintenance chapter e Fora list of compatible administration sets refer to Set Compatibility Card provided separately For specific administration set instructions refer to directions for use provided with set For set priming and loading instructions refer to Preparing Infusion section of this document Before operating instrument verify that administration set is free from kinks and installed correctly in instrument
103. z z f A 3 To enter bolus dose use numeric data entry keys n a NOTE After a bolus dose and weight if used are entered bolus VTBI and concentration conc alternate in the Main o Display e f no weight has previously been programmed in system VA Cueca Drug Library and bolus dose is weight based weight entry is empty BOLUS DOSE Dose Lo mg kg Conc 20 mg mL gt Enter Bolus Dose SETUP f programmed continuous dose is weight based EY Gaara Drug Ubray programmed weight displays as in illustrated example BOLUS DOSE which reflects use of Heparin in Pediatrics ICU C ____ unmg PATIENT WEIGHT 10 kg Conc 200 units mL gt Enter Bolus Dose SETUP f bolus dose is not weight based Not Used displays in PATIENT WEIGHT field GETTING STARTED 57 Programming Bolus Dose Continued Using KCTVI Tro e T M 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 Ly Cuadras Drug Library Lidocaine BOLUS DOSE DosE _ _ _ 5 mglkg eer kg DURATION Conc 20 mg mL gt Select PATIENT WEIGHT SETUP b To enter patient weight use numeric data entry keys PY Cuatarails Drug Library BOLUS DOSE DOSE 5 mg kg DURATION Conc 20 mg mL gt Select

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