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Alaris-Medley-Pump-Module-8100-version-5

1. 30 seconds as S9 2 To view primary and secondary volume s infused press Volume Infused PRI SEC VOLUME soft key TOTAL VOLUME mL itp O A 401 1 3002 03 10 WY B 42 5 Si gt C 478 4 8s zm D 78941 Ra u gt Select Channels to Clear or Press CLEAR ALL toe CA 3 To clear volume infused Volume Infused PRI mL SEC mL NOTE If no key is pressed main screen appears after A 401 1 0 0 30 seconds B 425 0 0 e f only selected channels are to be cleared press soft key C 428 1 500 next to applicable channel s and press CLEAR CHANNEL D 7394 90 0 soft key gt Select Channels to Clear or Press CLEAR ALL Volume clears on selected channel s ruses CLEAR a e f all channels are to be cleared press CLEAR ALL soft key Volume Infused To return to main screen press MAIN SCREEN soft key PRI mL SEC mL A 0 0 0 0 B 0 0 0 0 Cc 0 0 0 0 D 0 0 0 0 gt Select Channels to Clear or Press CLEAR ALL PRI SEC CLEAR MAIN VOLUME ALL SCREEN GETTING STARTED 29 Primary Mode Basic Infusion Continued AutoRestart The AutoRestart feature is part of the Medley System s Downstream Occlusion Detection system designed to minimize nuisance patient side occlusion alarms It allows the system to automatically continue an infusion following detection of a patient side occlusion if downstream pre
2. A m A NOTES WARNINGS e Since by definition a multidose infusion will not be infusing for The Multidose feature is to be a a programmed period of time it is assumed that another used only by personnel properly w infusing IV line will keep the vein open until the beginning of trained in using multidose the first dose and between subsequent doses There is no keep infusions E bhatt a at the completion of a programmed on ao aiea Oe differentiate single dose and e he Delay Options function for multidose infusions Is similar to multidose containers must be Delay Options for continuous drug infusions with the following tilized differences Delay for when scheduling a callback option is not available Single dose piggybacking systems in Multidose Mode employing check valve sets are not designed for use with multidose e Maximum allowable delay on a multidose infusion is 8 hours containers 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 GETTING STARTED 1 Multidose Mode Continued Programming with Volume Duration Enabled Continued 2 Perform step
3. 93 APPENDIX TRUMPET AND START UP CURVES ssssssssssssssssssssII Im mI en 95 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 INTENIIONALLY LEFI BLANK About the System INTRODUCTION bout 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 l NOTE The Medley Programming Module name will be changing in the near future to Medley Point of Care Unit The Medley Pump Module 8100 Series is intended for facilities that utilize infusion pum
4. CONFIRM 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 AC power cord was connected To discontinue Anesthesia Mode press No soft key Continue ANESTHESIA MODE No Yes gt Select Yes or No GETTING STARTED 63 Delay Options Delay Options can be enabled at the time the Medley System is configured for use If Delay Options is enabled an infusion can be programmed to be delayed for a specified period of time and a callback can be scheduled as described in the following sections NOTE Since by definition an infusion with Delay Options will not be infusing for a programmed period of time it is assumed that another infusing IV line will keep the vein open until the delayed infusion begins When a delay is programmed the infusion stops when complete and no KVO is delivered Delaying Infusion The delay period for an infusion can be programmed as a specific number of minutes or a time of day as described in the following sections An infusion delay can be programmed prior to or after an infusion is initiated Specifying by Minutes The Delay for option is used to program an infusion delay for a minimum of one minute and up to 120 minutes 1 Press DELAY OPTIONS soft key FA infusion Setup 40 muh 250 mL gt Press START DELAY SECOND
5. Soft Keys UE Channel Selected Indicator F infusion Setup Inactive Soft Key rate 40 mun Nonhighlighted indicates a TB 250m nonselected okey 9 Active Soft Key C Highlighted indicates a selected E 9 soft key gt Press START Prompt Bar se GE Look here for user prompts 16 GETTING STARTED Displays Continued Dynamic Pressure Display Midtown Hospital Adult ICU A 2500mL Dynamic Pressure Display Lm C Current operating pressure is D indicated by solid bar Beds Patient side occlusion pressure set point is indicated by tick mark VOLUME AUDIO INFUSED ADJUST CAUTION Although the dynamic pressure display bars tor the Medley Syringe Module and Pump Module both use the full width of the screen for display they each represent different ranges The Pump Module s range is 50 mmHg to 525 mmHg Start Up Refer to the Medley Programming Module Directions for Use for the following procedures e m G d P JJ m UO Powering On System Responding to Maintenance Reminder Selecting New Patient and Protile Options Entering Patient ID Moditying Patient ID Preparing Infusion The primary administration set must be primed before u
6. 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 prime and load primary administration set 3 Press CHANNEL SELECT key GETTING STARTED 75 Multidose Mode Continued Programming with Volume Duration Disabled Continued 4 Press Basic Infusion soft key A Infusion Menu Guardrails Drug Library e Infusion Setup screen appears Basic infusion gt Select an Option or EXIT RESTORE EXIT 5 Press OPTIONS key EN infusion Setup mlh VTBI mL gt Select Rate or Restore Previous Infusion VOLUME RESTORE Dem 6 Press Multidose soft key FY channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit P Channel Labels gt Select an Option or EXIT EXIT 7 To enter rate use numeric data entry keys f Multidose 13 00 ____ muh gt Enter Rate 76 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Disabled Continued 8 To enter volume to be infused for each dose press EX Multidose 13 00 VOLUME DOSE soft key and use numeric data entry keys 100 mL h __ mL gt Enter Volume Dose 9 To enter time interval 1 to 24
7. To stop infusion press PAUSE key on Pump Module 2 Close roller clamp 3 Remove empty solution container 4 Insert administration set spike into prepared fluid container following accepted hospital procedure and hang container 20 inches above Pump Module 5 Press CHANNEL SELECT key 6 To enter VTBI press VTBI soft key and use numeric data entry FEY infusion Setup keys Rate 40 mL vB 240 mL 7 Open roller clamp 8 To resume infusion press START soft key gt Press START VOLUME SECOND PAUSE DURATION ARY START Channel Labels Selecting Channel Label P 2 3 Press CHANNEL SELECT key Press OPTIONS key Press Channel Labels soft key A Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit P Channel Labels gt Select an Option or EXIT EXIT 36 GETTING STARTED Channel Labels Continued Selecting Channel Label Continued 4 Press soft key for desired label PY Channel Label Display 0 9 NaCl A E NOTE To view additional labels press a soft key next to a 3 NaCl F J letter group to navigate through alphabet and or PAGE UP CVVHDF Dialysate K O and PAGE DOWN soft keys D5 1 2 NS P T e Selected label is highlighted and scrolls in Channel uS Message Display gt Select Channel Label EXIT OUR Channel Label Display Adult ICU Peripherial Art Line Replacement S
8. WEIGHT DRUG LIBRARY 10 To indicate whether or not patient weight is to be used in EA Drug Calculation Drug Calculation press either Yes or No soft key 250 mg 250 mt Yes NOTE Do not enter a patient weight if weight is not used in Soe No the calculation Note Press Yes only if Patient weight is used in the calculation For Example Dosing Units mg kg h gt Use Patient Weight in Calculation DRUG 11 To enter patient weight if required in kilograms use EQ Drug Calculation numeric data entry keys 250m 250 mL vaca kg UNIT Conc 1000 mcg mL gt Enter Patient Weight DRUG LIBRARY 46 GETTING STARTED Setting Up Drug Calculation Continued Using Non Library Drug Continued 12 Press TIME UNITS soft key F Drug Calculation 250 mg 250 mL __ 70kg TIME UNITS Conc 1000 mcg mL gt Select TIME UNITS DRUG LIBRARY 13 To select time base for drug calculation press either Min KA Drug Calculation Hour or Day soft key 250 mg 250 mL 70 kg Min gt gt gt gt Hour RI Day Conc 1000 mcg mL gt Select Time Units DRUG LIBRARY e m G d P JJ m UO 14 Press soft key next to desired DOSING UNITS FY Drug Calculation DILUENT volue 250 mL wear 7O kg ME mcg kg
9. abels 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 lt gt z zi z gt Z O 2 NO Keypad Check membrane switches for damage MAINTENANCE 91 Inspection Requirements Continued 3 Seal and Mechanical Parts e Mechanism seal is not torn or worn Mechanical parts move freely do not hang up or bind and function properly e Torsion Spring on door functions properly Open Door and ensure Door Latch stays up and does not sag Periodic inspections of the hardware are required For detailed CAUTION instructions on performing periodic inspections and maintenance refer to the Medley Medication Safety System Technical Service Manual and supplemental service bulletins and Medley Maintenance Software User Manual Periodic inspections should only be performed by qualified service personnel Service Information Refer to the Medley Programming Module Directions for Use 92 MAINTENANCE WARRANTY ALARIS Medical Systems Inc hereinafter referred to as ALARIS Medical Systems warrants that A Each new ALARIS Medical Systems Medley Pump Module is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by ALARIS Medical Systems to the original purchaser B Ea
10. 40 mun 250 mL gt Press START DELAY SECOND ETM START 2 Press Delay until soft key EX Delay Options 08 00 Pause Delay for Delay until E gt Select a Delay Option 3 f Current time displayed is correct press CONFIRM soft key Delayed Options 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 If the current time has been previously confirmed the Time of Day screen will not be displayed gt CONFIRM Time of Day 4 To enter time of day infusion is to be initiated up to FY Delay Options 08 00 23 hours 59 minutes use numeric data entry keys Pause Delay for Delay until 7 gt Enter Delay Time 66 GETTING STARTED Delay Options Continued Delaying Infusion Continued Specifying by Time of Day Continued 5 Press CONFIRM soft key FY Delay Options 08 00 Pause Delay for BEVAT 9 00 None gt Select Callback or Press CONFIRM C ai Time infusion is scheduled to start appears on Main Midtown Hospital 5g C Display A Start at 09 00 ud 2 JJ rri J VOLUME AUDIO INFUSED ADJUST e f a Before callback has not been scheduled reference Midtown Hospital agag Scheduling a Callback secti
11. 0 5 10 15 20 25 30 Observation Interval min Continued mL h Nr 09 Flow Rate Error Flow Rat Flow Rate Error Start Up at 999 ml h initial 2000 1800 1600 1400 1200 1000 800 600 400 200 200 O 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 999 mL h initial 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 999 ml h 24 hrs 0 5 10 15 20 25 30 Observation Interval min Legend B Maximum rate error m Overall rate error Minimum rate error APPENDIX 97 gt V U m Z z gt x lt THIS PAGE INTENIIONALLY LEFI BLANK 98 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 Flo Stop Guardrails Medley and SmartSite are trademarks and registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective owners US Patent Nos 4 764 166 4 690 673 5 165 873 5 601 445 5 713 856 5 800 387 5 836 910 5 941 846 AU Patent Nos 596 552 634 811 693 662 703 178 703 203 719 254 728 366 AT 0 225 158 BE Brevet Belge No 0 225 158 CA Patented Brevet 1 258 212 1 296 092 2 026 518 CH 40 225 158 DE D B P Nos 0 422 855 P3686558 3 FR Brevet Nos 0 225 158 0 422 855 GB Patent Nos 0 225 158 0 42
12. CHANNEL SELECT key e During infusion Volume Remaining displays e Between infusions Number of doses completed and when next dose starts displays Yellow Standby Status Indicator illuminates EY Multidose 12 30 Rate 100 mL h Volume _ Dose 50 mL every 06 h x 04 doses Doses completed 0 Volume remaining 25 mL gt Press START PAUSE STAR FY Multidose 12 00 Rate 100 mL h Volume _ Dose 50 mL every 06 h x 04 doses Doses completed 1 Dose 2 Starts 19 00 gt Press START 78 GETTING STARTED Reviewing Serial Number Refer to the Medley Programming Module Directions for Use Reviewing Software Version Refer to the Medley Programming Module Directions for Use e m G d P JJ m UO GETTING STARTED 79 THIS PAGE INTENIIONALLY LEFI BLANK 80 GETTING STARTED ALARMS ADVISORIES ERRORS 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 pres
13. G d P JJ m UO 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 e The bolus VTBI cannot exceed the programmed continuous infusion VTBI e Programming and starting a bolus dose deletes any programmed delay e f no continuous rate is entered the infusion will end when the bolus has been delivered No KVO infusion will follow GETTING STARTED 49 Programming Bolus Dose Continued Using Guardrails Drug Library Calculation h Set up Drug Calculation as described in Setting Up Drug Calculation Using Guardrails Drug Library section but do not start infusion Press BOLUS soft key Nonweight based example gt Weight based example gt DOSE is highlighted NOTES e f the programmed continuous dose infusion Is outside the Guardrails Soft Limit for that care area a prompt appears before programming can continue If the Yes soft key is pressed programming continues If the No soft key is pressed the infusion needs to be reprogrammed e f the programmed continuous dose infusion is outside the Guardrails Hard Limit for that care area a prompt appears before programming can continue The infusion needs to be reprogrammed Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 67 5 mL h 250 mL 9 mg min Conc 8 mg mL gt Press START PAUS
14. Histo ml h User Input Rates Device Calculated Rates 0 1 9 99 0 01 0 1 10 99 9 0 1 100 999 1 1 MAINTENANCE 87 lt gt z m m z gt Z A m Specifications Continued Fluid Ingress Protection IPX1 Drip Proof Infusion of Air Means to Protect Patient from Ultrasonic Air in Line Detection Maximum single bolus size selectable 50 75 or 250 microliters nominal 500 microliters in Anesthesia Mode Infusion Pressure Maximum 654 mmHg Maximum Occlusion Alarm Threshold plus tolerance KVO Keep Vein Open Rate Factory Default Setting is 1 mL h if set rate is 1 mL h or above or set rate if rate is 0 9 ml h or below KVO Selection Range KVO rate can be set in System Configuration from 0 1 20 mL h in 0 1 mL h increments Occlusion Alarm Thresholds Pump Mode 525 mmHg at rates 230 mL h Varying level based on rate and patient back pressure at rates 30 mL h Selectable Mode User selected from 50 to 525 mmHg in 25 mmHg increments Operating Principle Positive displacement Rate Accuracy Rate accuracy of the Medley Medication Safety System is 5 at rates between 1 and 999 ml h and 25 596 at rates 1 ml h 95 of the time with 95 confidence under the conditions listed below Infusion Rate Range 0 1 to 999 mL h Ambient Temperature 68 4 F 20 42 C Source Container Height 20 inches above the top of the Pump Module Test Solution Distilled Water Distal Back press
15. NOTE If the bolus dose infusion is not followed immediately by a continuous dose infusion BOLUS COMPLETE appears on the Main Display e m G d P JJ m UO Continuous dose infusion if programmed initiates VIBI counts down on Main Display e At completion of continuous infusion An audio prompt sounds Red Alarm Status Indicator flashes Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO 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 EY Drug Calculation DOSE is highlighted CONTINUOUS INFUSION dis 21 mL h 250 mL 5 mcg kg min Conc 1000 mcg mL gt Press START PAUSE SETUP BOLUS START GETTING STARTED 55 Programming Bolus Dose Continued Using Non Library Drug Calculation Continued 3 Toenter bolus dose use numeric data entry keys NOTE After a bolus dose 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 requir
16. D Loading and Removing Primary Administration Set esee 19 2 Setting Up Primary Administration Set for Gravity Infusion sss sse 21 S S PRIMARY MODE BASIC INEUSIODN csi pecia tuo acier ESETE LEI EALEN ds 21 O Starting Rate volume InTUSIOF sees o p redackr etitm t ruina EFE rh raodo se Ter REESE ER Raub Sars 2 y Starting Volume Duration INTUSION us oun bere narsi enake sadara IR EPe REFERRI Y eu 23 2 PAU SIO INTO ON RR TTECCE A 25 i Restarting Infusion Following Infusion Complete 0 00 00 26 Changing dale pr VIB DUNN IMTUSIOIN eederevsmtdes d etoeruridciPsreevhIep a PUPPI PI RUE sete de 27 STOO MING IDTUS DEG cosseetue ss ORE IEISS TE HE IESU HUP LUST cues D Ei REPE ePi Ue EE 27 Selecting Pressure Mode Pump Selectable sss 28 Viewing and Clearing Volume InTUsed suus ciens sancita ERphR ERE aoid i riiai 29 eis M eens 30 SECONDARY MODE TCMEEM 21 Changing Primary Infusion Parameter During Secondary Infusion sss esses 34 E Stopping Secondary Infusion and Returning to Primary Infusion sisse sss esses 35 m CHANGING PRIMARY SOLUTION CONTAINER oaaao aaeoa aeaaaee aaaea dena 36 CHANNEL LABELS Mu ER 36 Selecting Channel Label 00 0 EEEE EEE EEEE ee ees 36 Remov
17. ET START 2 Press Delay for soft key FA Delay Options 08 00 Pause Delay for Delay until CA CALL DANK BACK gt Select a Delay Option BACK 64 GETTING STARTED Delay Options Continued Delaying Infusion Continued Specifying by Minutes Continued 3 To enter number of minutes up to 120 infusion is to be FY Delay Options 08 00 delayed for use numeric data entry keys Pause minutes Delay until CALL EAS BACK gt Enter Delay Time 1 120 min 3ACK BA 4 Press CONFIRM soft key FY Delay Options 08 00 Pause BAEVA 20 minutes Delay until None G Z G ed P JJ rm UO gt Select Callback or Press CONFIRM Delay period counts down on Main Display Midtown Hospital ggo A Start in 20 min VOLUME AUDIO INFUSED ADJUST e f a Before callback has not been scheduled reference Midtown Hospital 9 00 Scheduling a Callback section infusion automatically A VTBI 259 0 mL initiates at end of delay period VOLUME AUDIO INFUSED ADJUST GETTING STARTED 65 Delay Options Continued Delaying Infusion Continued Specifying by Time of Day The Delay until option is used to program an infusion delay for a minimum of one minute and up to 23 hours 59 minutes 1 Press DELAY OPTIONS soft key FA infusion Setup
18. a communication problem Administration set is not properly installed Infusion stops on affected channel Door opened during an infusion Infusion stops on affected channel Flo Stop Device is in open position while door is open Indicates either upstream occlusion or empty container Infusion stops on affected channel Increased back pressure sensed while infusing in pump delivery mode Infusion stops on affected channel Partial occlusion of patient side of IV line detected by AutoRestart feature Blocked pump chamber detected Clear air from line To continue infusion press RESET soft key and then RESTART key Ensure tubing is properly installed in Air in Line Detector If air is present clear air from administration set Press RESTART key or press CHANNEL SELECT key and then START soft key To silence alarm and clear message from screen press CONFIRM soft key Reattach module if desired ensuring it is securely clicked into place at Channel Release Latch If alarm is still present replace channel with an operational instrument Close roller clamp remove and reinstall administration set close door open roller clamp and then press RESTART key Close door Press RESTART key or press CHANNEL SELECT key and then START soft key Close roller clamp on administration set or close door Clear occlusion on fluid side of instrument If necessary refill drip chamber Press RESTART key or p
19. hours between doses press EX Multidose 13 00 DOSE INTERVAL soft key and use numeric data entry keys 100 mL h 50 mL e m G d P JJ m UO DOSE every __h gt Enter Dose Interval 10 To enter number of doses press OF DOSES soft key and use FY Multidose 13 00 numeric data entry keys 100 mL h e f Delay Options is enabled DELAY OPTIONS soft key is appears CE NOTE Reference Delay Options section to program an infusion delay When delaying an infusion a multidose cannot ESO MMEEROE be delayed for more than 8 hours and all doses in the DOSES multidose program must be completed within a 24 hour program 11 To begin multidose infusion press START soft key FY multidose 13 00 RATE 100 mL h pose 50 mb DOSE INTERVAL Very 06 h _4 doses gt Press START Continued on Next Page GETTING STARTED Multidose Mode Continued Programming with Volume Duration Disabled Continued e Main Display shows remaining VTBI for that dose e At completion of a multidose program MULTIDOSE COMPLETE appears on Main Display Midtown Hospital Adult ICU P 13 00 A VTBI 50 0 mL VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU 8 00 A MULTIDOSE COMPLETE VOLUME AUDIO INFUSED ADJUST 12 To see detail screen during or between infusions press
20. in fluid pathway latex free Drops per milliliter specification for product will be identified on drop symbol Product incorporates SmartSite Needle Free Valve Ports and should not be accessed by a needle N Product DOES NOT contain a particular element such as administration set is x XX ml Approximate administration set priming volume Expiration date for product will be identified near hour glass symbol Q Do not use if package is damaged INTRODUCTION 5 THIS PAGE INTENIIONALLY LEFI BLANK 6 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 WARN NG l 0G A warning is an alert to potential serious outcomes death injury or serious adverse events to the patient or user CAUTION A caution is an alert to take special care for the sate and effective use of the device Warnings and Cautions For WARNINGS and CAUTIONS for the Programming Module refer to its Directions for Use e EN G d gt JJ m I To ensure proper performance of the Medley System and to reduce potential injury observe the following precautions Epidural Ad
21. mL 9 mg min Conc 8 mg mL gt Press START PAUSE SETUP BOLUS START 3 Press RESTORE soft key F A Guerdraits Drug Library Lidocaine BOLUS DOSE LL rmo wet 71k e m Z G 2 P JJ m UO Conc 8 mg mL gt Enter Bolus Dose RESTORE SETUP Lidocaine BOLUS DOSE 5 mg kg T1 kg 999 mL h 2 min INFUSE AT 133 2 mg min Conc 8 mg mL gt Press START to Begin Infusing Bolus Dose PAUSE SETUP ioous START 4 Verify dosing parameters and press START soft key EY Suerirets Drug Library Bolus Dose Completed Channel Turned Off 1 Press CHANNEL SELECT key 2 Press RESTORE soft key A Infusion Menu Guardrails Drug Library Basic infusion gt Select an Option or EXIT RESTORE EXIT GETTING STARTED 59 Programming Bolus Dose Continued Restoring Bolus Dose Continued Bolus Dose Completed Channel Turned Off Continued 3 Verify parameters and press NEXT soft key Guardrails Drug Library Lidocaine DRUG 2 gram 250 mL PATIENT WEIGHT Not Used TIME UNITS min DOSING i UNITS mg min Conc 8 mg mL gt Press NEXT to Confirm NEXT 4 Verify infusion parameters and press BOLUS soft key Guardrails Drug Library Lidocaine CONTINUOUS INFUSION 67 5 mL h 250 mL 9 mg min Con
22. min gt gt mg kg min Conc 1000 mcg mL gt Select the Desired Dosing Units DRUG LIBRARY 15 Verity correct drug calculation infusion parameters and EY Drug Calculation press NEXT soft key mount 250 mg DILUENT voume 250 mL weent 70 kg WR Min DOING mcg kg min Conc 1000 mcg mL gt Press NEXT to Confirm DRUG LIBRARY NEXT GETTING STARTED 4 Setting Up Drug Calculation Continued Using Non Library Drug Continued 16 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 EY Drug Calculation CONTINUOUS INFUSION muh VIB mL PECES mcg kg min Conc 1000 mcg mL gt Select RATE or DOSE SETUP BOLUS 17 To enter volume to be infused press VTBI soft key and use numeric data entry keys NOTES e At rates less than 10 mL h the rate is displayed to two decimal places and the VTBI can be entered and is displayed to two decimal places e The BOLUS soft key appears only if Bolus Dose is enabled within the selected profile and a VTBI is entered e n the Drug Calculation mode the system infuses at the calculated rate rounded to the nearest one hundredth of a mL per hour as displayed on the Channel Programming screen The rate shown in the Channel Rate Display will be rounded
23. on drug selected weight entry if required e rate or dose entry and e VTBI entry 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 40 GETTING STARTED Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued 2 Perform steps in Preparing Infusion section to prime and load primary administration set Press CHANNEL SELECT key 4 Press Guardrails Drug Library soft key FEV infusion Menu Guardrails Drug Library Basic infusion e m gt Select an Option or EXIT Z Restore EXIT C ud A 5 Press soft key next to desired drug and concentration Ak Orug Library Aminophylline 500mg 250mL A E I NOTES Bretylium 500 mg 250mL F J To view additional drugs concentrations press a soft key Dobutamine 500mg 250mL K O next to a letter group to navigate through alphabet and or Dopamine 400mg 250mL P T PAGE UP and PAGE DOWN soft keys Dopamine 800mg 250mL U Z m The facility may choose to to prepopulate standard drug ENOAT concentrations or leave an open entry ml and allow the clinician to enter the desired concentration Ex ORUS PAGE 6 Tocontinue programming press Yes soft key EN ae Drug Library l Lidocaine Yes e Bol
24. see details during the bolus infusion press the EA Drug Calculation CHANNEL SELECT key BOLUS DOSE Dose Remaining 400 mcg Pt Weight Not Used 999 mL h Time Left lt 1 min ya TOTAL DOSE 500 mcg BOLUS VTBI 0 5 mL gt Press START to Continue Infusing Bolus Dose IPAUSE STOR START e 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 e m G d P JJ m UO Continuous dose infusion if programmed initiates VIBI counts down on Main Display e At completion of continuous infusion An audio prompt sounds e Red Alarm Status Indicator flashes Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO 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 GETTING STARTED 5 Programming Bolus Dose Continued Stopping Bolus Dose Continued 2 Press STOP BOLUS soft key Guardrails Drug Library
25. setup screen displays EA Infusion Setup PRIMARY T 50 mL h 240 mL gt Press START SECOND PAUSE ARY START 5 To resume secondary infusion press START soft key A Infusion Setup SECONDARY 100 mu h 55mL gt Press START PRIMARY START 34 GETTING STARTED Secondary Mode Continued Stopping Secondary Infusion and Returning to Primary Infusion 1 Press CHANNEL SELECT key 2 Press PRIMARY soft key EA infusion Setup D SECONDARY 3 Close clamp on secondary administration set RATE 100 mun OR vB 434m Disconnect secondary administration set from upper Injection port gt Press START PAUSE PRIMARY START 4 Press START soft key EN Infusion Setup PRIMARY RATE 5 mt h vB 240 mL e m G d P JJ m UO gt Press START SECOND PAUSE SER START 5 To stop secondary infusion and begin infusing primary EN infusion Setup press Yes soft key PRIMARY e Secondary infusion stops and primary infusion begins ZUR 240 mL Stop Secondary and Yes Infuse Primary No NOTE The SEC to PRI alert does NOT sound when the f gt Select Yes or No infusion is manually ended and returned to primary Main screen appears GETTING STARTED 35 Changing Primary Solution Container
26. to the nearest one tenth of a mL per hour EY Drug Calculation CONTINUOUS INFUSION 21 mL h c ill DOSE _5 mcg kg min Conc 1000 mcg mL gt Select VTBI SETUP BO LU S 18 Verify parameters are correct and press START soft key e During infusion Green Infusing Status Indicator illuminates e Rate appears in Channel Rate Display VIBI counts down on Main Display Dose scrolls in Channel Message Display Continued on Next Page EY Drug Calculation CONTINUOUS INFUSION 21 mL h 250 mL 5 mcg kg min Conc 1000 mcg mL gt Press START PAUSE sErUP BoLus START 48 GETTING STARTED Setting Up Drug Calculation Continued Using Non Library Drug Continued e At completion of infusion Midtown Hospital A COMPLETE If infusion ends in KVO An audio prompt sounds Red Alarm Status Indicator flashes Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display Mia KVO appears on Main Display e If infusion was delayed COMPLETE scrolls in Channel Message Display and appears on Main Display 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 e EN
27. 2 855 IT Brevettato Vol R A No 0 225 158 JP Patent Nos 8 1 816 872 9 2 594 604 8 NL Ned Octrooi No 0 225 158 SE Sv pat nr 0 225 158 TW Patent No NI 107963 Other Patents Pending 147029 006 Copyright 2003 ALARIS Medical Systems Inc All Rights Reserved
28. E E 68 PAUSINOGUSIOM nores 70 DATION IMME MEMEPM M 71 Programming with Volume Duration Enabled sse 71 Programming with Volume Duration Disabled uus eee 5 REVIEWING SERIAL NUMBER xus rait 13 vd aeegaues arro eder REPERI SEENEN rre Patre E ed apnd ors 79 REVIEWING SORT WARE VERSION xctaated ccneviurscheeaurendyes E raa Er a a E eet EERIEPEENESI 79 ALARMS ERRORS MESSAGES ENING M 81 AUDIO a2 572 Gi fled cd bo Gc aera eee eer eee ene ne ee eee AREE eee ee eee 82 PUI HE OP 83 4 9 L STL 84 ys ito 84 MAINTENANCE SG i Wig sp MEMMMM AM EMe 87 CONMIGURABUE SETTINGS 12 cvscseeeun apres tynoes AE a EE 4 aynend Goren e noe MEET EE UE 89 c clum Ij TM 89 Shared Infusion Settings Pump Module and Syringe Module uus 90 Pump ieeseberuds MMC 90 Bir cM Lx A A hS9 E 91 INSPECTION REOVUIREMENTS crossen petaech rae EES ra rr eTa eiaa 91 SERVICE INFORMATION rnosensrrnunnie pennie E ar EEEE EEEE T EETA eE a eis 92 aru ma
29. E SETUP BOLUS START Guardrails Drug Library Heparin CONTINUOUS INFUSION 20 0 mL h 500 mL 20 unit kg h Conc 10 units mL gt Press START PAUSE SETUP BOLUS START 50 GETTING STARTED Programming Bolus Dose Continued Using Guardrails Drug Library Calculation Continued 3 To enter bolus dose use numeric data entry keys NOTE After a bolus dose and weight If used are entered bolus VTBI and concentration conc alternate in the Main Display e f no weight has previously been programmed in system A SER and bolus dose is weight based weight entry is empty BOLUS DOSE DOSE _ _ _ _ mg kg Q EL m Conc 8 mg mL gt Enter Bolus Dose JJ l l If programmed continuous dose is weight based FX Guga Drug Library m programmed weight displays as in illustrated example BOLUS DOSE which reflects use of Heparin in Pediatrics ICU CZJ oss went 10kg DURATION Conc 10 units mL gt Enter Bolus Dose f bolus dose is not weight based Not Used displays in PATIENT WEIGHT field 4 Toenter or change patient weight if used use applicable following procedure depending on whether or not continuous dose is weight based e When continuous dose is not weight based a Press PATIENT WEIGHT soft key EA Guerdraits Drug Library BOLUS DOSE DOSE EE 5 mg kg PATIENT Fa DURATIO NI Co
30. ETTSRO9 00 Aft gt Select Callback or Press CONFIRM 68 GETTING STARTED Delay Options Continued Scheduling a Callback Continued f Delay until programming time infusion is scheduled to Midtown Hospital T oeng start appears on Main Display A Start at 09 00 OR e f Delay for programming delay period counts down on Midtown Hospital og 9o Main Display A Start in 20 min e m G d P JJ m UO VOLUME AUDIO INFUSED ADJUST e f Before option was selected Midtown Hospital 09 00 e An audio prompt sounds when delay period has A DELAY COMPLETE ended Yellow Standby Status Indicator flashes DELAY COMPLETE scrolls in Channel Message Display and appears on Main Display VOLUME AUDIO INFUSED ADJUST e f After option was selected A An audio prompt sounds when delayed infusion BE a has completes and continues to sound until responded to Yellow Standby Status Indicator flashes until audio is silenced gt Press CONFIRM Infusion completed message appears on Main Display Infusion Complete scrolls in Channel Message Display f Before and After option was selected same prompts and indicators mentioned above for both Before and After options are exhibited GETTING STARTED 69 Delay Options Continued Scheduling a Callback Continued 4 To respond
31. Enter patient identitier if required 2 Perform steps in Preparing Infusion section to prime and load primary administration set 3 Press CHANNEL SELECT key GETTING STARTED 21 Primary Mode Basic Infusion Continued 4 Press Basic Infusion soft key e Infusion Setup screen appears 5 Start an infusion as described in following Starting Rate Volume Infusion or Starting Volume Duration Infusion section Starting Rate Volume Infusion 1 Toenter flow rate press RATE soft key and use numeric data entry keys A Infusion Menu Guardrails Drug Library Basic infusion gt Select an Option or EXIT RESTORE EXIT ry Infusion Setup muh VIBI mL gt Select Rate or Restore Previous Infusion VOLUME RESTORE or 2 To enter VTBI press VTBI soft key and use numeric data entry keys 3 Attach administration set to patient s vascular access device E Infusion Setup 40 mun VTBI mL gt Select VTBI VOLUME DURATION 4 Verity 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 Continued on Next Page LY Infusion Setup RATE 40 mun _ 250m gt Press START VOLUME SECOND PAUSE te v J START 22 GETTING STARTED Primary Mode Basi
32. Gemini administration sets utilize a unique clamping device the Flo Stop Device to prevent inadvertent free flow when the administration set is removed from the instrument 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 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 INTRODUCTION 3 Z JJ e J N Z Guardrails Limit KVO Rate Adjust Multidose Mode Occlusion Pressure Restore Secondary Infusions Volume Duration Features and Definitions Continued 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 he
33. Infusion section to prime and load primary administration set Press CHANNEL SELECT key Press Guardrails Drug Library soft key FEY Infusion Menu Guardrails Drug Library Basic infusion gt Select an Option or EXIT RESTORE EXIT Press DRUG CALC soft key ey Aminophylline 500mg 250mL A E Bretylium 500 mg 250mL F J Dobutamine 500mg 250mL K O Dopamine 400mg 250mL P T Dopamine 800mg 250mL U Z gt Select Drug Concentration DRUG PAGE EXIT CALC DOWN To enter DRUG AMOUNT in IV container use numeric data FEY Drug Calculation entry keys DENN mcg OLUN mg FT unit gt Enter Amount of Drug in Container LIBRARY Press soft key for appropriate unit of measure for drug KA Drug Calculation amount KERN 250 mcg paro mg weenn gram UNIS unit kg mEq gt Select Unit of Measure DRUG LIBRARY GETTING STARTED 45 e m G d gt JJ m I Setting Up Drug Calculation Continued Using Non Library Drug Continued 8 Toenter diluent volume use numeric data entry keys E Drug Calculation DRUG 250 mg DILUENT MTS mL gt Enter Diluent Volume DRUG LIBRARY 9 Press PATIENT WEIGHT soft key FEY Drug Calculation 250 mg _ 250 mt UNITS Conc 1000 mcg mL gt Select PATIENT
34. Lidocaine BOLUS DOSE Dose Remaining 5 mg kg Pt Weight 71 kg Time Left 2 min TOTAL DOSE 355 mg BOLUS VTBI 44 4 mL gt Press START to Continue Infusing Bolus Dose PAUSE STO START 999 mL h ax Rate 3 To stop bolus and start continuous infusion press Yes soft key EY Guardrails Drug Library Lidocaine Stop Bolus and Start Yes Continuous infusion No gt Press Yes or No 4 To stop continuous infusion press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds 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 Midtown Hospital Adult ICU A VTBI 250 mL VOLUME AUDIO INFUSED ADJUST 58 GETTING STARTED 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 67 5 mL 250
35. Medley MEDICATION SAFETY SYSTEM PUMP MODULE 8100 Series DIRECTIONS FOR USE S3lidS 0018 JINGOIN diu fid TABLE OF CONTENTS INTRODUCTION BBOUT TEE SYSTENI eerren snc nsos wasn coche ssnupes SE ERENER EE ces teens FURTAT EREE P Te PE ERE Pads 1 FEATURES AND DEFINITIONS onana 3 OU M 5 2 GETTING STARTED s WARNINGS AND CAUTIONS aaaea aaa EEEE EEEE e les 7 O CONTROLS AND INDICATORS oaaae detta rie tende e ea e rebas 13 z JI EXP BEI MMEMM vV 15 Unpacking PUMP OE UB scs a esrreaerrh eo da turr E ES ETER obe EEr REE oak 15 ATTACHING AND DETACHING CHANNELS usus II een 15 5 DISPLASIA a 16 m EREE o o F 16 Dynamic Pressure Display sssssssssssssssssss e e eee en 17 UE ceo geese vee eee on oe ra pe E pene eae on ate Se pa ae ee ee 17 V POW CTI OM i Cm 17 gt Responding to Maintenance Reminder n l auauua anaana eE en 17 z Selecting New Patient and Profile Options 20 0000 17 C zUicdieblgpd MMEEHMEEMEEMT Tv 2 17 Nsenyssr u0abMMMHEMETT n 17 dusyi calde ig MM esa 17 PIGS 00dp uEM 18 gt Priming Primary Administration Set i isis ea 18
36. NEL SELECT key and then press PAUSE soft key on Programming Module e PAUSE scrolls in Channel Message Display e PAUSED appears on Main Display gt Press START e Yellow Standby Status Indicator illuminates PAUSE XLE SECOND START e After two minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes e m G d P JJ m UO O 2 Toreinitiate infusion Midtown Hospital Press RESTART key on Pump Module A PAUSED B VTBI 497 0 mL C VTBI 57 0mL D VTBI 249 0 mL OR vere ADJUST e Press CHANNEL SELECT key and then press START soft key KA infusion Setup on Programming Module RATE 40 mL h 500 mL gt Press START PAUSE pius SECOND START GETTING STARTED 25 Primary Mode Basic Infusion Continued Restarting Infusion Following Infusion Complete 1 If solution container and or administration set require replacement reference Preparing Infusion section to a Prepare solution container b Prime and load primary administration set 2 Press CHANNEL SELECT key 3 To restart infusion using stored parameters press RESTORE FEY infusion Menu soft key and continue with next step Guardrails Drug Library Basic infusion OR To start a new infusion follow steps for Starting Rate Volume Infusion or Starting Volume Duration Infu
37. NS Use only Medley System Gemini Series Administration Sets The use of any other set may cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard For a list of compatible sets refer to the Set Compatibility Card provided separately 8 GETTING STARTED Warnings and Cautions Continued GUIS To prevent a potential free flow condition ensure no extraneous object for example bedding tubing glove is enclosed or caught in the Medley Pump Module door ZB 7 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 EZB ll 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 User Precautions To ensure proper performance of the Medley System and to reduce potential injury to the operator observe the following precaution
38. accessed using the Guardrails Continuous Quality Improvement CQI Event Tracker and Guardrails CQI Event Reporter INTRODUCTION 1 About the System Continued This document provides directions for use for the Medley Pump Module Read all instructions for both the Pump Module and Programming Module before using the Medley System The Medley Pump Module uses a wide variety of Medley System Gemini Administration Sets The sets are designed for use with the Pump Module as well as for gravity flow stand alone use For specific administration set instructions refer to the directions for use provided with the set For set priming and loading instructions refer to the Start Up 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 AutoRestart Bolus Dose Channel Labels Delay Options Drug Calculation Dynamic Pressure Display Free Flow Protection Guardrails Clinical Advisory Guardrails Drug Library The AutoRestart feature is part of the Medley System s advanced Downstream Occlusion Detection system If enabled the AutoRestart feature minimizes nuisance patient side occlusion alarms caused by momentary kinki
39. alth system as either hard or soft limits e A Guardrails Hard Limit is a programmed limit that cannot be overridden A Guardrails Soft Limit is a programmed limit that can be overridden The KVO Rate Adjust option is used to select the KVO Keep Vein Open rate 0 1 to 20 ml h allowed This determines the rate of fluid flow after an Infusion Complete occurs The KVO rate will never exceed the infusion rate The Multidose Mode option allows 2 24 doses to be programmed at equally spaced intervals on the same Pump Module over a 24 hour period This mode is designed to allow delivery of multiple equal doses from the same IV container at regularly scheduled intervals A complete range of downstream occlusion detection options is provided e Pump mode Downstream occlusion alarm threshold is 525 mmHg at flow rates of 30 ml h or greater For rates 30 ml h the occlusion pressure is rate dependent to ensure rapid response to occlusions Selectable pressure mode Downstream occlusion alarm threshold can be adjusted in 25 mmHg increments up to the maximum occlusion pressure of 525 mmHg e AutoRestart See AutoRestart definition In addition the Medley System provides fluid side occlusion detection To simplify programming the Restore feature can be used to recall previous rate and volume settings for the same patient This option is only available if the patient is not new and the system is powered up within 8 hours
40. are 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 Six short beeps secondary switching to primary 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 volume 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 volume can be silenced and disabled in System Configuration 82 ALARMS ERRORS MESSAGES Alarms Alarm Meaning Response Accumulated Air in Line Air in Line Channel Disconnected Check IV Set Close Door Flo Stop Open Close Door Occluded Fluid Side Empty Container Occluded Patient Side Partial Occlusion Patient Side Pump Chamber Occluded A large number of air bubbles smaller than current air in line limit has recently passed detector Air has been detected in administration set during an infusion Infusion stops on affected channel Channel s disconnected while in operation or has
41. ata entry keys RATE ___ mL h VOLUME DOSE mL DURATION G G d P JJ mH UO gt Enter Volume Dose 10 To enter duration for each dose press DURATION soft key EY Multidose 13 00 and use numeric data entry keys RATE ___ mL h 50 mL NOTE RATE is calculated with each keystroke for DURATION Oh 2 min gt Enter Duration RATE VOLUME 11 To enter time interval 1 to 24 hours between doses press EX Multidose 13 00 DOSE INTERVAL soft key and use numeric data entry keys RATE 100 mL n 50 mL 00 n 30 min every h gt Enter Dose Interval RATE VOLUME GETTING STARTED 7 3 Multidose Mode Continued Programming with Volume Duration Enabled Continued 12 To enter number of doses press OF DOSES soft key and use numeric data entry keys e f Delay Options is enabled DELAY OPTIONS soft key appears NOTE Reference Delay Options 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 13 00 RATE 100 mL h eese 50 mL DURATION OQ h 30 min every Oh OF DOSES gt Select NUMBER OF DOSES RATE VOLUME 13 To begin multidose infusion press START soft key e Main Display shows remaining VTBI
42. atically The secondary solution container When the instrument is programmed and delivering in the must be higher than the primary secondary mode the primary infusion is temporarily stopped solution container and fluid is drawn from the secondary container Delivery from o The secondary VTBI settings require consideration of such variables as factory overfill medication additions etc Underestimating the volume will cause the remaining secondary solution to be infused at the primary rate overestimating will result in the primary solution being infused at the secondary rate Multiple doses from a single container are not possible the primary container resumes when the fluid level in the secondary line is level with the fluid in the primary container NOTE Prepare the secondary container and administration set Lower the primary container using the hanger included with the secondary set e m G d gt JJ mH UO The clamp on the secondary administration set must be opened If the clamp is not opened the fluid will be delivered from the primary container The secondary administration set must be primed prior to beginning the secondary infusion 1 Open secondary administration set package remove set and close clamp 2 Insert administration set spike into prepared fluid container and hang secondary container following accepted hospital procedure 3 Fil drip chamber to 2 3 fu
43. c 8 mg mL gt Press START PAUSE SETUP BOLUS START 5 Press RESTORE soft key Al Guardrails Drug Library Lidocaine BOLUS DOSE se noo wear 71 kg Conc 8 mg mL gt Enter Bolus Dose RESTORE SETUP 6 Verity dosing parameters and press START soft key Guardrails Drug Library Lidocaine BOLUS DOSE 5 mg kg T1 kg 999 mL h 2 min INFUSE AT 133 2 mg min Conc 8 mg mL gt Press START to Begin Infusing Bolus Dose PAUSE SETUP ioous START 60 GETTING STARTED Anesthesia Mode When the Medley System is operating in Anesthesia Mode a CAUTION channel can be paused indefinitely without an alarm i When the Medley System is set up Anesthesia Mode also makes it possible to have additional drugs 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 the use of the Anesthesia Mode When Anesthesia Mode is enabled e All Guardrails Limits are set to Soft Dose checking mode is s
44. c Infusion Continued Starting Rate Volume Infusion Continued e During infusion Midtown Hospital 1 1 VTBI 250 L e Green Infusing Status Indicator illuminates gl ea e Rate appears in Channel Rate Display C Remaining VTBI appears on Main Display D e At completion of infusion If infusion ends in KVO An audio prompt sounds wuss ANS Red Alarm Status Indicator flashes Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO appears on Main Display If infusion was delayed COMPLETE scrolls in Channel Message Display and appears on Main Display G EN G d P JJ m UO Starting Volume Duration Infusion 1 Press VOLUME DURATION soft key EN infusion Setup mih VIBI mL gt Select Rate or Restore Previous Infusion VOLUME RESTORE DM 2 To enter VTBI press VTBI soft key and use numeric data entry FY infusion Setup keys RATE mL h vret m DURATION h min gt Select VTBI RESTORE RATE VOLUME GETTING STARTED 23 Primary Mode Basic Infusion Continued Starting Volume Duration Infusion Continued 3 Toenter volume duration press DURATION soft key and use numeric data entry keys e Rate is automatically calculated 4 Attach administration set to patient s vascular access device A Infusion Se
45. ch 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 e a repaired by anyone other than an authorized ALARIS Medical Systems Service Representative b nN altered in any way so as to affect in ALARIS Medical Systems judgment the produc
46. diagrams component parts lists and descriptions test procedures and other technical information to assist qualitied service personnel in repair and maintenance of the instrument s repairable components Maintenance procedures are intended to be performed only by qualified personnel using the service manual and Medley Maintenance Software Specifications Accumulated Air Window Bolus Volume following Occlusion Maximum Critical Volume Single Bolus Setting Volume Window mL 96 Air that Causes Alarm 50 2 8 1096 5 8 0 20 250 8 0 30 500 12 0 30 In Anesthesia Mode only Pressure Limit mmHg Rate ml h 25 50 0 3 mL 525 lt 0 6 mL The maximum over infusion which can occur in the event of a single fault condition is 0 6 mL Dimensions 3 3 W x 8 9 H x 5 5 D Environmental Conditions Operating Temperature Range 41 to 104 F 5 to 40 C Relative Humidity 20 to 90 Avoid prolonged exposure Noncondensing Storage Transport 4 to 140 F 20 to 60 C 5 to 85 Noncondensing to relative humidity gt 85 Atmospheric Pressure 700 to 6080 hPa Equipment Orientation To ensure proper operation Electrical Classification Class 1 Type CF Defibrillator 525 to 4560 mmHg 375 to 760 mmHg 500 to 1013 hPa the system must remain in an upright position Proof Flow Rate Programming Rate Range Increments mL h
47. e 1 UJ N PI d Remove Pump Module from its carton Verify door operates freely Verify membrane covering inside surface of pumping unit is not cut or torn Check for loose parts Perform Periodic Inspection see Inspection Requirements section in Maintenance chapter e Fr G d P JJ mH UO Perform check in procedure reference Medley Maintenance Software User Manual included with 8970C or later for details If the Pump 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 15 Displays The displays illustrated throughout this document are for illustration purposes only The display content will vary depending on configuration settings type of administration set in use hospital defined data set uploaded using the Guardrails Safety Software programmed drug calculation parameters and many other variables Main Display Title Bar Midtown Hospital Adult ICU Channel Status an vrBi 2500mL 3 Asolid channel letter display E indicates channel is operating c E e An outlined channel letter TO display indicates channel is attached and ready for use
48. ecess below mechanism with arrow pointing into Pump Module See figure at end of this section Using a finger tip firmly push tubing toward back of Air in Line Detector See figure at end of this section Close Pump Module door e Flo Stop Device is automatically disengaged Open roller clamp Verify no fluid is flowing through drip chamber CAUTION When reloading an administration set leave the Flo Stop Fitment in the closed position see Flo Stop Device section G m G d P JJ m UO GUS To prevent a potential free flow condition ensure no extraneous object for example bedding tubing glove is enclosed or caught in the Medley Pump Module door GETTING STARTED 19 Preparing Infusion Continued Loading and Removing Primary Administration Set Continued Loading Administration Set Continued 1 Load upper tubing fitment 0 9 0 0 0 0 O O L rA E y f 2 Load Flo Stop Fitment Q aaa 3 Firmly push tubing toward back of Air in Line Detector N Removing Administration Set 1 Close roller clamp 2 Open Pump Module door Set s Flo Stop Device automatically closes to prevent accidental free flow 3 Remove set by gently pulling tubing below Air in Line Detector forward and out and then lifting upper fitment vertically from upper fitment recess 4 fsetis be
49. ed EY Drug Calculation BOLUS DOSE mcg DOSE EN 500 imcg kg PATIENT WEIGHT mg DURATION mg kg Conc 1000 mcg mL gt Select the Desired Dosing Units SETUP 5 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 e TOTAL DOSE alternates with INFUSE AT rate EX Drug Calculation BOLUS DOSE 500 meg weisnt Not Used 999 mL h DURATION min Wax TOTAL DOSE 500 mcg Conc 1000 mcg mL gt Enter Duration SETUP 6 Verify parameters are correct and press START soft key e During infusion Green Infusing Status Indicator illuminates e Rate appears in Channel Rate Display Dose scrolls in Channel Message Display Bolus VTBI counts down on Main Display Continued on Next Page A Drug Calculation BOLUS DOSE 500 meg PATIENT weicHt Not Used soo mun lt 1 min INFUSE AT gt 9999 mcg min Conc 1000 mcg mL gt Press START to Begin Infusing Bolus Dose CONT PAUSE SETUP nos START Midtown Hospital Adult ICU A BOLUS VTBI 0 5 mL VOLUME AUDIO INFUSED ADJUST 56 GETTING STARTED Programming Bolus Dose Continued Using Non Library Drug Calculation Continued NOTE To
50. en Infusing Status Indicator illuminates e Rate appears in Channel Rate Display Dose and drug name scroll in Channel Message Display NOTE If 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 Main Display alternates between Bolus VTBI and drug name with dose Continued on Next Page Guardrails Drug Library Lidocaine BOLUS DOSE 9 mg kg T1 kg 999 mL h 2 min INFUSE AT 133 2 mg min Conc 8 mg mL gt Press START to Begin Infusing Bolus Dose PAUSE SETUP KOA START Midtown Hospital Adult ICU A BOLUS VTBI 44 4 mL VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU A Lidocaine 5 mg kg Bolus VOLUME AUDIO INFUSED ADJUST 54 GETTING STARTED Programming Bolus Dose Continued Using Guardrails Drug Calculation Continued NOTE To see details during the bolus infusion press the A TE did CHANNEL SELECT key BOLUS DOSE Dose Remaining 5 mg kg Pt Weight 71 kg ES Time Left 2 min Rate TOTAL DOSE 355 mg BOLUS VTBI 44 4 mL gt Press START to Continue Infusing Bolus Dose Pause STO START e At completion of bolus infusion System beeps twice BOLUS DOSE COMPLETE scrolls in Channel Message Display
51. en clamp on secondary administration set EY infusion Setup SECONDARY RATE 100 mush E 55m 12 Verify correct infusion parameters and press START soft key G EN G d P JJ m UO gt Press START PAUSE PRIMARY START e During infusion Midtown Hospital e Green Infusing Status Indicator illuminates A SEC VTBI 55 0 mL B VTBI 497 0 mL VTBI 57 0mL Secondary VTBI counts down on Main Display D VTBI 249 0 mL SECONDARY scrolls in Channel Message Display At completion of infusion Switchover alert sounds with six beeps unless INFUSED ASST disabled in system configuration Secondary rate appears in Channel Rate Display Primary rate displays Infusion continues at primary rate GETTING STARTED 33 Secondary Mode Continued Changing Primary Infusion Parameter During Secondary Infusion 1 Press CHANNEL SELECT key 2 Press PRIMARY soft key A Infusion Setup SECONDARY RATE 100 mL h 55 mL gt Press START PRIMARY START 3 To change primary infusion parameter press applicable soft key RATE or VTBI and use numeric data entry keys A Infusion Setup PRIMARY RATE 40 muh vet 240 mL gt Press START SECOND PAUSE R START 4 Verify correct primary infusion parameters and press SECONDARY soft key e Secondary
52. esia 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 Anesthesia Mode VOLUME AUDIO INFUSED ADJUST System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT 62 GETTING STARTED Anesthesia Mode Continued Disabling Anesthesia Mode Continued From System Options Menu Continued 3 Press Disable soft key System Options Anesthesia Mode 4 Press CONFIRM soft key ca e Anesthesia Mode no longer appears on Main Display ku indicating it has been disabled Pump Module Air Detection nange 75 microliters gt Select an Option or Press CONFIRM Disconnecting System from AC Power While in Anesthesia Mode 1 Disconnect system from AC e m G d P JJ m UO e Anesthesia Mode is automatically disabled e All currently running infusions continue A prompt appears as an alert that Anesthesia Mode has been discontinued 2 Press CONFIRM soft key Anesthesia mode was discontinued when AC power cord was disconnected Press CONFIRM to continue normal operation
53. et to Smart e Key press audio is turned off Tamper Resist Mode panel locked is not available e All Guardrails Drug Library entries are available for selection e EN G d P JJ m UO Bolus dose is automatically available for drugs in Guardrails Drug Library that have bolus dose limits defined and generic drug calculation setup regardless of system configuration settings Anesthesia Mode alternating with other required prompts displays in prompt bar of Main Display e Callback audio for paused channels is permanently silenced e 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 GETTING STARTED 61 Anesthesia Mode Continued Enabling Anesthesia Mode Continued 3 Press Enable soft key System Options Anesthesia Mode 4 Press CONFIRM soft key Disable P Modul pirbetesure change T5 microliters gt Select an Option or Press CONFIRM 5 Press Channel Select key NOM ospital A 6 Program Anesthesia Mode infusion using same procedure as for any other continuous infusion e D Disabling Anesthesia Mode The Anesth
54. ey to confirm Guardrails Drug Library Lidocaine 2 anim 250 mL weicht Not Used UNITS min BRAL mg min Conc 8 mg mL gt Press NEXT to Confirm NEXT A Guardrails Drug Library Heparin DRUG 5000 units 500 mL PATIENT kg TIME UNITS hour POSING units kg h Conc 10 units mL gt Enter Patient Weight NEXT 8 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 mL h ml NEMPE mg min Conc 8 mg mL gt Select Rate or Dose SETUP BOLUS 42 GETTING STARTED Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued 9 To enter volume to be infused press VTBI soft key and use E UNO numeric data entry keys CONTINUOUS INFUSION 67 5 mL h NOTES EN e At rates less than 10 mL h the rate is displayed to two E ou decimal places and the VTBI can be entered and is displayed to two decimal places Enema gt Select VTBI e The BOLUS soft key appears only if Bolus Dose is enabled UT within the selected profile the drug is bolusable and a SETUP BOLUS VTBI is entered Q e In the Drug Calculation mode the system infuses at the a calculated rate rounded to the nearest one hundredth of a mL per hour as disp
55. f Pressure Variations Under conditions of 100 mmHg pressure the Medley Pump Module typically exhibits a long term accuracy offset of approximately 0 7 from mean values Under conditions of 300 mmHg pressure the Medley Pump Module typically exhibits a long term accuracy offset of approximately 4 2 from mean values Under conditions of 100 mmHg pressure the Medley Pump Module typically exhibits a long term accuracy offset of approximately 4 4 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under these pressure conditions Effects of Negative Solution Container Heights With a negative head height of 0 5 meters the Medley Pump Module typically exhibits a long term accuracy offset of approximately 3 1 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under negative head height conditions 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 Medley System Gemini Model 2210 Administration Sets APPENDIX 95 gt aa IU Z z x Flow Rate mL h Fl
56. for that dose e At completion of a multidose program MULTIDOSE COMPLETE appears on Main Display A Multidose 13 00 RATE 100 mL h 50 mL 00 n 30 min every 06 n _4 doses gt Press START DELAY RATE ER VOLUME START Midtown Hospital Adult ICU P 13 00 A VTBI 500mL VOLUME AUDIO INFUSED ADJUST Midtown Hospital f Adult ICU P 8 00 A MULTIDOSE COMPLETE VOLUME AUDIO INFUSED ADJUST 74 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Enabled Continued 14 To see detail screen during or between infusions press Multidose 12 30 CHANNEL SELECT key Rate 100 mL h pe OO tie During infusion Volume Remaining displays Duration 00 n 30 min every 06 h x 04 doses Doses completed 0 Volume remaining 25 mL gt Press START Between infusions FY Multidose 12 00 Number of doses completed and when next dose Rate 100 mL h starts display poet DO mi Duration OO h 30 min Yellow Standby Status Indicator illuminates cue 06 f xA doses Doses completed 1 Dose 2 Starts 19 00 gt Press START G m G d P JJ m UO 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
57. g mEq or units Patient weight Weight of patient kg this is an optional parameter that is not needed unless drug dose is normalized for patient weight e Time units Time base for all calculations minute hour or day Continued on Next Page GETTING STARTED 39 Setting Up Drug Calculation Continued Drug Calculation Parameters Continued The bolus dose drug dose and flow rate parameters are calculated using the above parameters as follows e Bolus dose bolus dose x patient weight if used e Bolus dose administration rate INFUSE AT When duration is entered total dose duration in minutes When Max Rate is used Max Rate 60 x concentration e Bolus dose duration bolus VTBI bolus rate Bolus dose VTBI bolus dose drug concentration e Bolus rate bolus VTBI duration e Continuous drug dose flow rate x drug concentration normalized for patient weight if specified by entering a patient weight e Continuous flow rate drug dose drug concentration normalized for patient weight if specified by entering a patient weight e Drug concentration 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
58. ge Display NOTE lf a 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 TT for a high dose Main Display alternates between VTBI and drug name with dose e At completion of infusion Midtown Hospital e If infusion ends in KVO A COMPLETE An audio prompt sounds Red Alarm Status Indicator flashes Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO with drug name scrolls in Channel Message Display PM KVO appears on Main Display If infusion was delayed COMPLETE 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 select a new profile d Enter patient identifier if required 44 GETTING STARTED Setting Up Drug Calculation Continued Using Non Library Drug Continued Perform steps in Preparing
59. ge appears based on new weight Adjust Dose or Rate if required Accept weight change Yes No gt Select Yes or No e Press BOLUS soft key E reis Drug Library CONTINUOUS INFUSION 20 0 mL h 500 mL 18 18 unitkgh Conc 10 units mL gt Press START Pause SETUP BOLUS START e Z G 2 gt JJ mm UO f To enter bolus dose use numeric data entry keys oe D BOLUS DOSE DOSE __unit kg weient 11 kg DURATION Conc 10 units mL gt Enter Bolus Dose SETUP 5 Press DURATION soft key A Suerdraits Drug Library Lidocaine BOLUS DOSE 5 mg kg mM 1kg TOTAL DOSE 355 mg Conc 8 mg mL gt Select DURATION SETUP GETTING STARTED 53 Programming Bolus Dose Continued Using Guardrails Drug Calculation Continued 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 e TOTAL DOSE alternates with INFUSE AT rate Al Guardrails Drug Library Lidocaine BOLUS DOSE 5 mgro T1 kg 999 mL h DUNS min wa TOTAL DOSE 355 mg BOLUS VTBI 44 4 mL gt Enter Duration SETUP 7 Verify parameters are correct and press START soft key e During infusion Gre
60. icroliters 0 9 attempts Anesthesia Mode only 9 attempts 0 1 20 ml h 0 1 99 9 mL h in 0 1 ml h increments 100 999 mL h in 1 0 mL h increments 0 1 9999 mL Pump Selectable Locked Unlocked 50 525 mmHg in 25 mmHg increments adjustable only in Selectable Pressure Mode Enabled Disabled Enabled Disabled 90 MAINTENANCE 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 is S M iud apri nino in the Failure to perform these inspections art Up section of this directions for use before each usage o may result in improper instrument the instrument Regular inspections must be performed by the operation 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 Seal 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 e Case is clean and free from IV solution residue especially near moving parts Accessible areas of air in line sensor pressure transducers and latch mechanism are clean and free from IV solution residue
61. ing Channel Label 2 cnesuoo ter ur eo tre RT SEDI PTT RP EET EEEE EEEE EEEE EEEE EEEE 38 POWERING OFF MMNMEMMMEEMEMMEM A A BA memm 39 POWEnnO i MERERETUR 39 uo CHING Ol CAE M MRMETTTTE E 39 gt ve IU Z z x TABLE OF CONTENTS GETTING STARTED Continued SETTING UP DRUG GAUGUIN seeren ER eats A RESE 39 Drug Caiculatiorn ParameloiS ct caccacnenecansnectaes ceenssgsadeeadads oi ctoanddatansanghaedacaat eaekant ead 39 Using Guarorails Drug LOGY nccucxx3inbieiatchatngegdenae suse i aaaea E t dete tendu nl 40 Using NOE Naty Drug oop ces caetaned on tacnsornepove sonetaoedun aeaieie d e SERA aiaa k i dania a 44 PROGRAMMING BOLUS DOSE ooa aaea EEE EEEE EEEE pre ER ER P EEEE EEEE 49 Using Guardrails Drug Library Calculation sisse ee 50 Using Non Library Drug Calculation s B Stopping BOIS DOSE uuo rd rca terere esu eaedem ede Tide a OERLE RENEE EPERE bad 57 Restoring Bolus DOSE rsrs erat Er Pr RUIN AAEE so EREA ERAR RN AEAT E RAE EE NE a a PE 58 ANE SAE SIP MODE errr e E E EEE ES A ASRA 61 Enabiifig Anesthesia Mde os seme tbe ded E A EAE ARAA ERI 61 Disabling Anesthesia Mode 0 e ee een 62 pide De D I 64 Delaying WAU SION MRRRTRERRNCTREEETTERIUI 64 Scheduling a CONDE d M
62. ing removed to begin a gravity flow a Depress blue ridged release tab on upper side of Flo Stop Device b Slide white slide clamp into blue fitment open position c Adjust flow rate using set s roller clamp 20 GETTING STARTED Preparing Infusion Continued Setting Up Primary Administration Set for Gravity Infusion 1 Prime administration set Priming Primary Administration Set 2 Adjust container to hang 20 inches above patient s vascular access device Attach administration set to patient s vascular access device 4 Adjust flow rate with administration set roller clamp Primary Mode Basic Infusion The following procedures should be used only when programming a Basic Infusion To program an infusion using the Guardrails Drug Library go to the Setting Up Drug Calculation section G m G d P JJ m UO NOTES e The illustrations in this section assume the following e Drug Calculation Dynamic Pressure Display Profiles and Volume Duration configurable settings are enabled Delay Options configurable setting is disabled e f Delay Options is enabled the PAUSE soft key becomes DELAY OPTIONS e The RESTORE soft key appears only if a previous infusion was programmed for the same patient 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 protile d
63. layed on the Channel Programming C screen The rate shown in the Channel Rate Display will 2 be rounded to the nearest one tenth of a mL per hour s 10 Verify parameters are correct and press START soft key CERTUS Dag BR x CONTINUOUS INFUSION 67 5 mL 250 mL 9 mg min Conc 8 mg mL gt Press START PAUSE SETUP BOLUS START NOTE If the programmed continuous dose infusion is outside A ondes the Guardrails Soft Limit for that care area a prompt appears Dose exceeds Yes before programming can continue If the Yes soft key is Se A Tae pressed programming continues if the No soft key is pressed Proceed the infusion needs to be reprogrammed gt Press Yes or No EXC EES Drug Library NOTE If the programmed continuous dose infusion is outside Lidocaine the Guardrails Hard Limit for that care area a prompt NM Repregram uararais nar appears before programming can continue The infusion limit of 8 mg min needs to be reprogrammed gt Press REPROGRAM Continued on Next Page GETTING STARTED 43 Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued Ing I ion Midtown Hospital e During infusion Midtown Hospita e Green Infusing Status Indicator illuminates A VTBI 250 mL e Rate appears in Channel Rate Display Dose and drug name scroll in Channel Messa
64. ll 4 Open secondary administration set and prime set Close clamp GETTING STARTED 31 Secondary Mode Continued 5 Attach secondary administration set to upper injection site on primary set 6 Lower primary fluid container using hanger provided with secondary administration set NOTE The secondary container should be at least 91 2 inches above the top of the fluid level in the primary container 7 Setup and start primary infusion reference Primary Mode Basic Infusion section using a check valve administration Set 8 Press SECONDARY soft key and continue with next step OR To use previous secondary infusion parameters if available press RESTORE soft key and proceed to step 12 EY Infusion Setup RAE 40 mL h VTBI 240 mL gt Press START PAUSE SECOND START EN Infusion Setup SECONDARY RATE mL h VIBI mL gt Select Rate or Restore Previous Infusion RESTORE 9 Toenter secondary infusion rate press RATE soft key and use numeric data entry keys EY Infusion Setup SECONDARY _ muh mL gt Select RATE 32 GETTING STARTED Secondary Mode Continued 10 To enter secondary volume to be infused press VTBI soft key and use numeric data entry keys Al Infusion Setup SECONDARY 100 mL h DEED gt Select VTBI 11 Op
65. ministration 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 a Medley System Gemini Series administration set without a Y WARNING nn injection port for epidural infusions SSDISSIQEDIIBISCHON quo a eps It is strongly recommended that the Epidural administration of anesthetic drugs Use source container Medley System indwelling catheters specifically indicated for short term Gemini Administration Set and Pump 96 hours or less anesthetic epidural drug delivery Module used for epidural drug Epidural administration of analgesic drugs Use indwelling delivery be clearly differentiated from catheters specifically indicated for either short term or those used for other types of long term analgesic epidural drug delivery administration WARN NG 1 This instrument is designed to stop fluid flow under alarm conditions Periodic patient monitoring must be performed to ensure the infusion Is proceeding as expected GETTING STARTED Warnings and Cautions Continued ANNA The Guardrails Safety Software incorporates dosing limits and instrumen
66. nc 8 mg mL gt Select PATIENT WEIGHT SETUP GETTING STARTED 51 Programming Bolus Dose Continued Using Guardrails Drug Calculation Continued b To enter patient weight use numeric data entry keys OR E Guardrails Drug Library Lidocaine BOLUS DOSE 5 mg kg PATIENT WEIGHT o o kg Conc 8 mg mL gt Select DURATION SETUP e When continuous dose is weight based a Press SETUP soft key b Press PATIENT WEIGHT soft key C To change patient weight use numeric data entry Keys d Press NEXT soft key Continued on Next Page EY Guardrails Drug Library Heparin BOLUS DOSE DES 50uikg went 10 kg TOTAL DOSE 500 units Conc 10 units mL gt Select DURATION SETUP A ess Drug Library Heparin 5000 units 500 mL 10 kg Nfs Hour DOSING units kg h Conc 10 units mL gt Press NEXT to Confirm DRUG ERAS NEXT Guardrails Drug Library Heparin 5000 units 500 mL E 11 kg UNITS Hour POSING units kg h Conc 10 units mL gt Press NEXT to Confirm DRUG RS NEXT 52 GETTING STARTED Programming Bolus Dose Continued Using Guardrails Drug Calculation Continued Al Guardrails Drug Library NOTE lfa continuous infusion is running a prompt Heparin Dose will recalculate to confirm the weight chan
67. nd infusion setup c E Pause Key When pressed during qu an infusion temporarily stops infusion on that channel After 2 minutes PRESS START visual and audio prompt begins OO OY 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 ve channels to power off each channel Restart Key When pressed resumes operation of a previously paused or alarmed infusion on that channel UA pM y Door Handle Channel Release Latch GETTING STARTED 13 e m G d gt JJ m I Controls and Indicators Continued Front View Door Open IUI Connector Left not visible Upper Tubing me Fitment Retainer A IUI Connector Right Upper Pressure Sensor Platen Upper Occluder Upper Pumping Finger Door Latch Cam Slide Lower Occluder Lower Pumping Finger LETT Lower Pressure Sensor D I ppp sl LEA Tubing Keeper iui Ji il rri VAN Air in Line Sensor 14 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 in use Unpacking Pump Modul
68. ng of tubing IV pushes etc 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 minutes or b for a specific time up to 23 hours 59 minutes A callback for a programmed delay can be scheduled to give an alert Before an infusion is to be initiated After an infusion is completed Before and After an infusion or no alert None The Drug Calculation mode allows entry of drug dose Medley System calculates correct flow rate to achieve desired dose OR e entry of flow rate Medley System calculates corresponding drug dose The Dynamic Pressure Display appears on the Main Display If enabled it graphically displays the current patient side occlusion pressure set point and the current patient side operating pressure for that module Reference Displays section in Getting Started chapter for additional Dynamic Pressure Display information All Medley System
69. numeric keys on the Programming Module GETTING STARTED 2 Primary Mode Basic Infusion Continued Selecting Pressure Mode Pump Selectable 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Pressure Limit soft key Al Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit P Channel Labels gt Select an Option or EXIT EXIT 4 Press either Pump or Selectable pressure soft key If Selectable is pressed continue with next step otherwise proceed to step 7 Pressure Limit Selection Selectable gt Select an Option or EXIT EXIT 5 To select occlusion pressure limit press either Up or Down soft key 6 Verify correct occlusion pressure limit input and press CONFIRM soft key 7 Press START soft key Pressure Limit Selection Selectable Pressure 525 mmHg Up Down CONFIRM 28 GETTING STARTED Primary Mode Basic Infusion Continued Viewing and Clearing Volume Infused 1 To view volume infused press VOLUME INFUSED soft key Adult Use A PAUSED B VTBI 497 0 mL C VTBI 570mL D VTBI 249 0 mL e Total volume infused primary secondary and time and date volume infused was last cleared display for each channel NOTE Date format is year month day e f no key is pressed main screen appears after
70. occurred AutoRestart feature monitoring downstream pressure to determine if infusion can continue Delay time completed Current infusion completed Programmed volume to be infused delivered channel running at KVO rate Tamper Resist feature Is active and a key was pressed Response Press CONFIRM soft key None 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 If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of Programming Module 84 ALARMS ERRORS MESSAGES Messages Continued Message Meaning Response Panel Unlocked Tamper Resist feature deactivated None Pause Pause control pressed infusion To resume infusion press RESTART stopped key or press CHANNEL SELECT key and then START soft key Secondary Secondary infusion in progress on None When secondary VTBI 0 indicated channel infusion will revert to programmed primary parameters Start time for next dose has passed Start of next dose passed Press CONFIRM soft key gt Z J m a C cU rn JJ e JJ un ALARMS ERRORS MESSAGES 85 THIS PAGE INTENIIONALLY LEFI BLANK 86 ALARMS ERRORS MESSAGES MAINTENANCE The Medley System Technical Service Manual is available from ALARIS Medical Systems It includes routine service schedules interconnect
71. of last usage Dual rate sequential piggyback Secondary infusions may be infused at delivery rates and volumes independent of the primary infusion parameters Automatic changeover occurs to the primary infusion parameters when the secondary infusion is complete if a Medley System Gemini Check Valve Administration Set is used 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 4 INTRODUCTION Symbols Canadian and U S Certification Mark Products bearing this mark have been tested and h B 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 Z JJ Ir Ji Electrical Shock Protection Rating Type CF Defibrillation proof 2 C n IPX1 Protection against fluid ingress Drip Proof O zZ N Attention Refer to accompanying documentation gt IUI Connector Inter Unit Interface connector used to establish power and communications between the Programming Module and attached modules Manufacturing Date Number adjacent to symbol indicates the month and year of MM YYYY manufacture HF i Consult operating instructions R Only CAUTION Federal U S A law restricts this device to sale by or on the order of a physician Single Use Q Single Use Do not re use Product contains a particular element such as DEHP
72. olution Swan Triple Lumen 4 0 0 7 G Fm G d P JJ mm UO gt Select Channel Label PAGE PAGE PASE Back E 5 To continue infusion press START soft key Infusion Setup OR RATE 50 mL h VTBI 240 mL Program infusion as previously described gt Press START VOLUME SECOND PAUSE ferro ARY START GETTING STARTED 37 Channel Labels Continued Removing Channel Label 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Channel Labels soft key EY Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit P Channel Labels gt Select an Option or EXIT EXIT 4 Press CLEAR LABEL soft key abel stops scrolling 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 CLEAR PAGE ee LABEL DOWN 5 To begin infusion press START soft key OR Program infusion as previously described FA infusion Setup RATE 5 mL h viB 240 mL gt Press START VOLUME SECOND PAUSE Ec ARY START 38 GETTING STARTED Powering Off Refer to the Medley Programming Module Directions for Use to the following procedures Powering Off System Powering Off Channel Set
73. on infusion automatically A VTBI 259 0 mL initiates at end of delay period VOLUME AUDIO INFUSED ADJUST GETTING STARTED 6 7 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 e Before gives an alert when delay is completed and infusion needs to be initiated e After gives an alert when delayed infusion has completed e Before and After gives an alert when delay is completed and infusion needs to be initiated and when delayed infusion has completed The default callback None or the callback for the current profile appears on the Main Display To schedule a different callback 1 Prior to pressing CONFIRM soft key to initiate delay during Delay for or Delay until programming process press CALL BACK soft key A Delay Options 08 00 Pause Delay for ZEE oo None gt Select Callback or Press CONFIRM NO Press soft key corresponding to desired callback option e Scheduled callback appears on Main Display Al Delay Options 08 00 Pause Delay for Borang Delay until 09 00 5d are CALL After BACK D 52522 None gt Select a Callback Option 3 To initiate delay press CONFIRM soft key Continued on Next Page A Delay Options 08 00 Pause Delay for Br AEW
74. otocol e Discard administration set per facility protocol SmartSite Needle Free System e SmartSite Needle Free Valve Port is contraindicated for blunt cannula systems e Swab top of SmartSite Needle Free Valve Port with preferred antiseptic prior to each access NOTES e f applicable attach syringe to SmartSite Needle Free Valve Port and aspirate minute air bubbles in an emergency SmartSite Valve may be accessed by a needle and will leak if punctured To access port with needle without causing leakage attach a PRN adapter of sufficient length to SmartSite Needle Free Valve Port 10 GETTING STARTED 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 functioning under optimal conditions these currents may appear as artifacts simulating actual ECG readings To determine if ECG abnormalities are caused by patient condition or the ECG equipment place the infusion device on hold If the ECG readings become normal the ECG equipment requires attention Proper setup of the ECG equipment should eliminate these artifacts Reference the appropriate ECG monitoring system documentation for Instructions on setup and maintenance Dropping Jarring Should an instrument be dropped o
75. ow Rate Error 96 0 02 Flow Rate Error 96 Trumpet and Start Up Curves Continued Start Up at 0 1 ml h initial 0 20 0 18 0 16 0 14 0 12 0 10 0 08 0 06 0 04 0 02 0 00 100 110 120 0 10 20 30 40 50 60 70 80 90 Time min Trumpet Curve at 0 1 ml h initial 100 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 0 1 ml h 72 hrs 0 5 10 15 20 25 30 Observation Interval min NOTE The plot range has been increased to 100 to allow visualization of the graph Start Up at 1 ml h initial 2 0 1 8 1 6 1 4 1 2 1 0 0 8 0 6 0 4 0 2 0 0 0 2 Flow Rate mL h 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 1 ml h initial e a a Flow Rate Error e 5 4 10 15 i i 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 1 mL h 72 hrs 15 a 5 Flow Rate Error e 0 9 10 15 20 25 30 Observation Interval min Legend Overall rate error B Maximum rate error Minimum rate error 96 APPENDIX Flow Rate Error 96 Flow Rate mL h Flow Rate Error Trumpet and Start Up Curves Start Up at 25 ml h initial 50 45 40 35 30 25 20 15 10 5 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 25 mL h initial 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 25 ml h 72 hrs
76. ps 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 Z JJ O J N Z 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 that occur during use is stored within the Medley Programming Module and can be
77. r severely jarred it should be immediately taken out of use and inspected by qualified service personnel to ensure its proper function prior to reuse GsALYVLS ONILLAD Operating Environment lt q DANGER amp Not for use in the presence of flammable anesthetics Explosion risk if used in the presence of flammable anesthetics EXPLOSION HAZARD GETTING STARTED 11 Warnings and Cautions Continued User Precautions Continued Radio Frequency Interference WARNING Operating the system near equipment which radiates high Use of accessories or cables other energy radio frequencies electrosurgical cauterizing than those specified may result in equipment portable radios cellular telephones etc may degraded electromagnetic cause false alarm conditions If this happens reposition the compatibility performance of this 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 12 GETTING STARTED Controls and Indicators Front Side View Door Closed IUI Connector Right Status Indicators not visible Alarm Infusing Standby IUI Connector Left red green yellow Rate Display Channel Message Display pe as ad o o a Channel Identification Channel Select Key When pressed selects corresponding channel for infusion parameter entry a
78. re enabled the settings are configured independently for each profile A hospital defined best practice data set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles System Settings Refer to the Medley Programming Module Directions for Use lt gt z mi z gt Z O mi MAINTENANCE 89 Configurable Settings Continued Shared Infusion Settings Pump Module and Syringe Module Feature Default Setting Options Delay Options Disabled Enabled Disabled e Callback None None Before After Before and After Drug Calculation Disabled Enabled Disabled e Bolus Dose Disabled Enabled Disabled Multidose Disabled Enabled Disabled e Callback None None Before After Before and After Pressure Dynamic Disabled Enabled Disabled Dynamic Pressure Display Volume Duration Disabled Enabled Disabled Pump Module Settings Feature Default Setting Options Accumulated Air in Line Air in Line Settings single bolus AutoRestart Attempts KVO Rate Adjust Keep Vein Open Max Rate Max VTBI Pressure Mode e Mode Selection e Lock Status e Max Occlusion Pressure SEC to PRI Alert Secondary Dual Rate Sequential Piggybacking Enabled 75 microliters 1 ml h 999 mL h 9999 mL Pump Unlocked 525 mmHg Enabled Disabled Enabled Disabled 50 75 or 250 microliters Anesthesia Mode only 500 m
79. ress CHANNEL SELECT key and then START soft key Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key Clear occlusion Press RESTART key or press CHANNEL SELECT key and then START soft key Open door and inspect pump chamber To open blockage as required massage tubing To continue infusion press RESET soft key and then RESTART key ALARMS ERRORS MESSAGES 83 gt Z J m a C cU rn JJ e JJ un Alarms Continued Alarm Meaning Restart Channel Door opened and closed during an gt infusion Infusion stops on affected channel Channel paused for 2 minutes gt Errors Response Close door Press RESTART key or press CHANNEL SELECT key and then START soft key Press RESTART key or press CHANNEL SELECT key and then START soft key Error Meaning Channel Error Error detected Operation stops on affected channel Response 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 Message Messages Meaning Anesthesia Mode Bolus Dose Complete Checking Line Delay Complete Infusion Complete Infusion Complete KVO Panel Locked Anesthesia Mode discontinued when disconnected from AC Channel running in continuous infusion mode if programmed Patient side occlusion
80. s e Disconnect from main AC power when performing maintenance e The instrument case should only be opened by qualified service personnel using proper grounding techniques GETTING STARTED 9 e m G d P JJ m UO Warnings and Cautions Continued User Precautions Continued Administration Sets WARNING Fora list of compatible administration sets refer to Set Use only Medley System Gemini Compatibility Card provided separately Series administration sets The use of For specific administration set instructions refer to any other set may cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard directions for use provided with set For set 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 e Pump Module administration sets are supplied with a sterile fluid path for one time use Do not resterilize e Fluid path is STERILE and NONPYROGENIC e Discard if packaging is not intact or protector caps are unattached e 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 e Flush port s per facility pr
81. s in Preparing Infusion section to prime and load primary administration set 3 Press CHANNEL SELECT key gt Press Basic Infusion soft key e Infusion Setup screen appears A Infusion Menu Guardrails Drug Library Basic infusion gt Select an Option or EXIT RESTORE EXIT 5 Press OPTIONS key EY Infusion Setup muh vTBI mL gt Select Rate or Restore Previous Infusion VOLUME RESTORE Bees 6 Press Multidose soft key Al Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit P Channel Labels gt Select an Option or EXIT EXIT 7 f Current time displayed is correct press CONFIRM soft key EY Multidose otherwise press Change Time and enter correct time Time of Day Reference Setting Up Time of Day procedure in Medley Programming Module Directions for Use NOTE If the current time has been previously confirmed the Time of Day screen will not be displayed Current time Change 13 00 Time gt CONFIRM Time of Day CONFIRM 2 GETTING STARTED Multidose Mode Continued Programming with Volume Duration Enabled Continued 8 Press VOLUME DURATION soft key EY Mutidose 13 00 ____ mlh gt Enter Rate 9 To enter volume to be infused for each dose use numeric FY Multidose 13 00 d
82. se see WARNING Priming Primary Administration Set section It can be loaded Use only Medley System Gemini into the Pump Module to deliver a large volume infusion see Series Administration Sets The use of Loading and Removing Primary Administration Set section or any other set may cause improper it can be set up to deliver a gravity infusion see Setting Up instrument operation resulting in an Primary Administration Set for Gravity Infusion section inaccurate fluid delivery or other a T potential hazard For a list of The Flo Stop Device is a tubing fitment that is part of all compatible sets refer to the Set Medley System Gemini administrations sets see Flo Stop Compatibility Card provided Device section separately GETTING STARTED 17 Preparing Infusion Continued Flo Stop Device The primary administration set s Flo Stop Fitment is a unique clamping device that prevents Inadvertent free flow when the administration set is removed from the instrument Flo Stop Device in Open Position When a new Medley System Gemini administration set Is removed from the package the Flo Stop Device is in the open position white slide clamp aligned with blue fitment In this open position flow is not occluded but is allowed as required for the priming process The roller clamp is used to control flow during the priming process see Priming Primary Administration Set section Flo S
83. sing 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 clinician 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 NOTE This feature is only available with Pump Module Versions 1 11 22 5 and greater 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 gt Z J m a C cU rn JJ e JJ un ALARMS ERRORS MESSAGES 81 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 Hardw
84. sion gt Select an Option or EXIT RESTORE EXIT 4 Verify parameters are valid and press START soft key EY infusion Setup RATE 40 mL h NOTE To change a restored parameter VIBI 500 mL 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 gt Press START PAUSE jos SECOND START 26 GETTING STARTED Primary Mode Basic Infusion Continued Changing Rate or VTBI During Infusion 1 Press CHANNEL SELECT key 2 Press either RATE or VTBI soft key FY infusion Setup RATE 40 mL h vii 240 mL gt Press START VOLUME SECOND PAUSE DURATION ARY START 3 To enter desired parameter use Up Down Arrows for rate VA Infusion Setup titration or use numeric data entry keys _50 muh vii 240mL 4 Verify correct infusion parameter entry and press START soft key e m G d P JJ m UO gt Press START VOLUME SECOND PAUSE eaa ARY START Stopping Infusion Press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds and then release to initiate power down NOTES e If 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
85. ssure falls to an acceptable level within a 15 second Checking Line period If this feature is enabled the Checking Line function will occur when downstream pressure exceeds the Pressure Limit e n Selectable Pressure Mode the Pressure Limit will be either user adjustable or locked in system configuration n Pump Pressure Mode the Pressure Limit is a function of flow rate and is automatically determined by the device If the downstream pressure decreases to a predetermined level below 50 of the Pressure Limit during the 15 second Checking Line period the infusion automatically continues If the condition is not cleared within 15 seconds a Partial Occlusion Patient Side alarm occurs Qualified Service personnel can configure the system to allow from zero 0 to nine 9 restart attempts within a rolling 10 minute period If the allowable number of restarts is exceeded or if the feature is set to zero an Occluded Patient Side alarm will occur when the system detects downstream pressure over the Pressure Limit 30 GETTING STARTED Secondary Mode This mode is designed to support automatic secondary infusions WARNINGS piggybacking in the same instrument channel When the Secondary applications require the secondary VTBI reaches zero an audio tone will sound indicating use of a check valve set on the completion of the secondary infusion The primary infusion primary IV line resumes autom
86. t 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 GUIS 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 NE This Medley Pump 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 GAINS Hospital facility personnel must ensure the compatibility of the drugs as well as the performance of each module as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms GUNNS Do not use the Medley System in close proximity of Magnetic Resonance Imaging MRI GAI
87. t s stability or reliability c subjected to misuse or negligence or accident or which has had the product s serial or lot number altered effaced or removed Or d improperly maintained or used in any manner other than in accordance with the written instructions furnished by ALARIS Medical Systems This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of ALARIS Medical Systems and ALARIS Medical Systems does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of ALARIS Medical Systems any other liability in connection with the sale or use of ALARIS Medical Systems Products ALARIS Medical Systems DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION lt gt z zi z P Z A 2 See packing inserts for international warranty if applicable MAINTENANCE 93 THIS PAGE INTENIIONALLY LEFI BLANK 94 MAINTENANCE APPENDIX Trumpet and Start Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND START UP CURVES In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual administration sets cause short term fluctuations in rate accuracy The following graphs show typical performance of the system for both Pressure and Resistance Modes in
88. ting Up Drug Calculation The drug calculation can be set up for a drug stored in the WARNINGS Guardrails Drug Library or for a non library drug as described The Drug Calculation feature is to in the following sections To access the drug library a hospital be used only by personnel properly defined best practice data set must be uploaded using the uamed Inahe administratiomot Guardrails Safety Software and the Profiles feature must be continuously infused medications enabled Extreme caution should be exercised to ensure the correct Drug Calculation Parameters entry of the drug calculation infusion parameters e Fm G d gt JJ mH UO The Medley System uses the following parameters entered during the drug calculation setup procedure e References in this document to specific drugs and drug doses are Bolus dose duration Time period over which bolus dose is for illustration purposes only to be administered Refer to specific drug product Bolus dose units Units used in calculating bolus dose labeling for information Bolus dose units are selected from alternatives provided concerning appropriate administration techniques and 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 dosages e Drug amount Amount of drug in IV container gram mg mc
89. to a callback Pausing Infusion Before callback Press CHANNEL SELECT key and then START soft key OR Press RESTART key After callback Press CONFIRM soft key Before and After callback Respond as indicated above for both Before and After 1 Press DELAY OPTIONS soft key FA infusion Setup 40 mun 250 mL gt Press START DELAY SECOND ETM START 2 Press Pause soft key NOTES e Using the Pause function in the Delay Options screen is the same as pressing the PAUSE key on the Pump Module he time displayed in the upper right corner of the screen is the time of day in a 24 hour clock format military time FA Delay Options 09 30 Pause Delay for Delay until gt Select a Delay Option BACK CONFIRM 3 Press CONFIRM soft key PAUSE scrolls in Channel Message Display PAUSED appears on Main Display Yellow Standby Status Indicator illuminates After two minutes PAUSE RESTART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes FA Delay Options 09 30 Delay for Delay until NI LALL BACK DAUR gt Press CONFIRM 70 GETTING STARTED Delay Options Continued Pausing Infusion Continued 4 Toreinitiate infusion FA Infusion Setup e Press RESTART key 40 mun 250 mL OR e Press CHANNEL SELECT key and then START soft key gt Press START DELAY SECOND ETM START
90. top Device in Closed Position When a Medley System Gemini administration set is removed from the Pump Module the instrument automatically engages the Flo Stop Device in the closed position white slide clamp projects out from under blue fitment In this closed position flow is occluded Priming Primary Administration Set 1 Prepare primary solution container in accordance with manufacturer s directions for use 2 Open administration set package remove set and close roller clamp Reference set s Directions For Use 3 Insert administration set spike into prepared fluid container following accepted hospital procedure and hang container 20 inches above Pump Module 4 Fill drip chamber to 2 3 full 5 If container requires venting open vent cap on administration set spike 6 To prime tubing and clear air trom injection sites and tubing fitments slowly open roller clamp When priming is complete close roller clamp p Verify no fluid flow 18 GETTING STARTED Preparing Infusion Continued Loading and Removing Primary Administration Set Loading Administration Set If a new set is being loaded prime set see Priming Primary Administration Set section Open Pump Module door Install administration set pumping chamber by properly positioning upper fitment into fitment recess See figure at end of this section Holding tubing below pumping segment insert Flo Stop Fitment into r
91. tup RATE mlh 1000 mL DURATION h min gt Select DURATION RATE VOLUME 5 Verify correct infusion parameter entry and press START soft key e During infusion Green Infusing Status Indicator illuminates e Rate appears in Channel Rate Display VIBI counts down on Main Display key To return to previous screen press START soft key At completion of infusion e If infusion ends in KVO An audio prompt sounds Red Alarm Status Indicator flashes Channel Rate Display changes to KVO rate INFUSION COMPLETE KVO scrolls in Channel Message Display KVO appears on Main Display If infusion was delayed COMPLETE scrolls in Channel Message Display and appears on Main Display ry Infusion Setup RATE 125 mun 1000 mL 8 00 hh mm gt Press START RATE SECOND PAUSE vel ARY START EY Infusion Setup 125 mL h 875 mL Time Left O7 n OO min gt Press START PAUSE ESTA Eca START Midtown Hospital Adult ICU A VTBI 250 0 mL D VOLUME AUDIO INFUSED ADJUST 24 GETTING STARTED Primary Mode 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 Pump Module E infusion Setup OR RATE 40 mL h VTBI 500 mL Press CHAN
92. two ways 1 Accuracy during various time periods over which fluid delivery is measured trumpet curves 2 Delay in onset of fluid flow when infusion commences start up curves Trumpet curves are named for their characteristic shape They display discrete accuracy data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug being infused and on the degree of intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered The start up curves represent continuous flow rate versus operating time for two hours from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data FLOW CHARACTERISTICS UNDER VARYING DELIVERY CONDITIONS Effects o
93. ure O mmHg 0 kPa Needle 18 gauge Administration Set Model 2210 GINS ll 00 Variations of head height back pressure or any combination of these may affect rate accuracy Factors that can influence head height and back pressure are Administration set configuration IV solution viscosity and IV solution temperature Back pressure may also be affected by type of catheter Refer to the Trumpet and Start Up Curves section in Appendix chapter for data on how these factors influence rate accuracy Time to Alarm Maximum Pressure Limit mmHg Rate mL h 50 525 1 lt 5 minutes lt 45 minutes 25 lt 15 seconds 2 minutes 88 MAINTENANCE Specifications Continued Volume to be Infused Range Increments Programming Increments mL mL 0 1 9 99 0 01 10 999 9 0 1 1000 9999 1 Weight 2 5 Ibs 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 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 featu
94. us dose units appear if Bolus Dose is enabled 2 gram 250mL was selected No OR Is this correct l UNITS mg min To change selection press No soft key BOLUSABLE BOLUS posne mg kg UNITS gt Press Yes or No e f Yes was selected and facility has defined a Clinical occae PIE Advisory for that drug a message appears To indicate Clinical Advisory information has been noted and continue programming Watch IV site carefully for press CONFIRM soft key signs of extravasation Continued on Next Page gt Press CONFIRM CONFIRM GETTING STARTED 41 Setting Up Drug Calculation Continued Using Guardrails Drug Library Continued e f Yes was selected to continue programming drug amount and diluent volume if defined in Guardrails Drug Library are automatically entered for selected drug e fselected drug had ml concentration drug amount and diluent volume need to be entered e f selected drug is not weight based Not Used displays in PATIENT WEIGHT field as in illustrated example e f hospital practice guidelines identity 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 7 Verify parameters are correct and press NEXT soft k

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