Alaris Medical Systems Medley 8100 Series Directions For Use Manual
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Alaris Medical Systems Medley 8100 Series Directions For Use Manual

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  • Page 2 GENERAL CONTACT INFORMATION Customer Advocacy - North America Clinical and technical feedback. Phone: (800) 854-7128, Ext. 7812 E-Mail: CustomerFeedback@alarismed.com Technical Support - North America Maintenance and service information support; troubleshooting. United States: Canada: Phone: Phone: (858) 458-6003 Eastern: (800) 908-9918 (800) 854-7128, Ext.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS INTRODUCTION ABOUT THE PUMP MODULE ..................FEATURES AND DEFINITIONS .
  • Page 4 PROGRAMMING (Continued) SETTING UP DRUG CALCULATION ................Drug Calculation Parameters .

  • Page 5: Introduction

    INTRODUCTION About the Pump Module The Medley ™ Pump Module ( Series) is intended for 8100 facilities that utilize infusion pumps for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration;...

  • Page 6: Features And Definitions

    Features and Definitions Reference the “Alarms, Errors, Messages” chapter of the Medley ™ Point-of-Care Unit Directions for Use ) for the definitions of various alerts. Reference the Point-of-Care Unit for system features and definitions. Auto-Restart Part of Medley ™ System’s advanced Downstream Occlusion Detection system.
  • Page 7 Features and Definitions (Continued) Guardrails ® Drug Library 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 profiles. Drug Library use automates programming steps, including drug name, drug amount and diluent volume, and activates hospital-established best-practice Guardrails ®...

  • Page 8: Symbols

    Features and Definitions (Continued) Restore To simplify programming, 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 hours of last usage.
  • Page 9 Symbols (Continued) Product contains a particular element; such as, in fluid pathway. DEHP DEHP Product contain a particular element; such as, = administration set is DOES NOT LATEX latex-free. Drops per milliliter specification for product will be identified on drop symbol. Product incorporates SmartSite ®...
  • Page 10 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K Pump Module, 8100 Series INTRODUCTION Directions for Use...

  • Page 11: Getting Started

    GETTING STARTED Warnings and Cautions Warnings and Cautions provided throughout this Directions for Use ( ) provide information needed to safely and effectively use the Medley ™ Pump Module and accessories. Medley ™ System Warnings and Cautions, and definitions, are covered in the Point-of-Care Unit General WARNINGS...

  • Page 12: Guardrails Safety Software

    Warnings and Cautions (Continued) Guardrails ® Safety Software WARNINGS • The Guardrails ® Safety Software incorporates dosing limits and instrument configuration parameters based on hospital/facility protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital/facility.

  • Page 13: Administration Sets

    Warnings and Cautions (Continued) Administration Sets WARNINGS • 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, reference the Set Compatibility Card (provided separately).

  • Page 14: Operating Features, Controls And Indicators

    Operating Features, Controls and Indicators Front/Side View - Door Closed IUI Connector, Right Status Indicators (not visible) Alarm Infusing Standby (red) (green) (yellow) IUI Connector, Left Rate Display Channel (Module) Message Display Channel (Module) Identification Channel (Module) Select Key: When pressed, selects corresponding module for infusion parameter entry and infusion setup.
  • Page 15 Operating Features, Controls and Indicators (Continued) Front View - Door Open IUI Connector, Left not visible Upper Tubing Fitment Retainer Platen IUI Connector, Right Upper Pressure Sensor Upper Occluder Upper Pumping Finger Door Latch Cam/Slide Lower Occluder Lower Pumping Finger Lower Pressure Sensor Flo-Stop ®...

  • Page 16: Installation

    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. Prior to placing the Medley ™ System in use: Perform check-in procedure per Medley ™...

  • Page 17: Start-Up

    Start-Up Reference the Medley ™ Point-of-Care Unit for the following procedures: Powering On System Responding to Maintenance Reminder Selecting New Patient and Profile Options Entering Patient Modifying Patient Preparing Infusion Administration Set WARNING Use only Medley ™ System/Gemini The Medley ™...

  • Page 18: Flo-Stop Device

    Preparing Infusion (Continued) Administration Set (Continued) SmartSite ® Needle-Free System • The SmartSite ® Needle-Free Valve Port is contraindicated for blunt cannula systems. • Swab the top of the SmartSite ® Needle-Free Valve Port with preferred antiseptic prior to each access. NOTES: •...

  • Page 19: Priming Primary Administration Set

    Preparing Infusion (Continued) Flo-Stop ® Device (Continued) Blue Fitment Flo-Stop ® 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).
  • Page 20 Preparing Infusion (Continued) Loading and Removing Primary Administration Set Loading Administration Set If a new set is being loaded, prime set (reference “Priming CAUTION Primary Administration Set” section). Insert upper fitment BEFORE Open Pump Module door. installing the Flo-Stop ® Fitment.
  • Page 21 Preparing Infusion (Continued) Loading and Removing Primary Administration Set (Continued) Loading Administration Set (Continued) Close door and latch, as follows: WARNINGS a. Close door and hold in a closed position by grasping • Do not touch the administration set while closing the door. door and instrument case with hand.

  • Page 22: Setting Up Primary Administration Set For Gravity Infusion

    Preparing Infusion (Continued) Loading and Removing Primary Administration Set (Continued) Removing Administration Set (Continued) Remove set, as follows: a. Gently pull tubing below Air-in-Line Detector forward and out. b. Lift upper fitment from upper fitment receptacle. If set is being removed to begin a gravity flow: a.

  • Page 23: Programming

    PROGRAMMING References throughout this chapter to specific drugs and drug doses are for illustration purposes only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages. Primary Mode - Basic Infusion The following procedures should be used only when programming a Basic Infusion.

  • Page 24: Starting Rate/Volume Infusion

    Primary Mode - Basic Infusion (Continued) Starting Rate / Volume Infusion To enter flow rate, press soft key and use numeric RATE Infusion Setup data entry keys. _ _ _ RATE mL/h _ _ _ _ VTBI >Select Rate or Restore Previous Infusion VOLUME RESTORE...

  • Page 25: Starting Volume/Duration Infusion

    Primary Mode - Basic Infusion (Continued) Starting Volume / Duration Infusion Press soft key. VOLUME DURATION Infusion Setup _ _ _ RATE mL/h _ _ _ _ VTBI >Select Rate or Restore Previous Infusion VOLUME RESTORE DURATION To enter , press soft key and use numeric data VTBI VTBI...

  • Page 26: Pausing Infusion

    Primary Mode - Basic Infusion (Continued) Starting Volume / Duration Infusion (Continued) Infusion Setup NOTE: To view infusion Time Left, press CHANNEL 125 mL/h key. To return to previous screen, press RATE SELECT START soft key. VTBI 875 mL 07 00 Time Left: >Press START VOLUME...

  • Page 27: Restarting Infusion Following Infusion Complete

    Primary Mode - Basic Infusion (Continued) Pausing Infusion (Continued) • Press key and then press CHANNEL SELECT START Infusion Setup soft key (on Point-of-Care Unit). RATE mL/h VTBI >Press START SECOND- VOLUME PAUSE START DURATION Restarting Infusion Following Infusion Complete If solution container and/or administration set require replacement, reference “Preparing Infusion”...

  • Page 28: Changing Rate Or Vtbi During Infusion

    Primary Mode - Basic Infusion (Continued) Changing Rate or VTBI During Infusion Press key. CHANNEL SELECT Press either soft key. RATE VTBI Infusion Setup RATE mL/h VTBI >Press START VOLUME SECOND- PAUSE START DURATION To enter desired parameter, use Up/Down Arrows for rate Infusion Setup titration or use numeric data entry keys.

  • Page 29: Selecting Pressure Mode - Pump / Selectable

    Primary Mode - Basic Infusion (Continued) Selecting Pressure Mode - Pump / Selectable Press key. CHANNEL SELECT Press key. OPTIONS Press Pressure Limit soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit - P Channel Labels >Select an Option or EXIT EXIT Press either Pump or Selectable pressure soft key.

  • Page 30: Viewing And Clearing Volume Infused

    Primary Mode - Basic Infusion (Continued) Viewing and Clearing Volume Infused To view volume infused, press soft key. Midtown Hospital VOLUME INFUSED Adult ICU PAUSED • Total volume infused (primary + secondary), and time VTBI = 497.0 mL and date volume infused was last cleared, display for VTBI = 57.0 mL each module.

  • Page 31: Auto-Restart

    Primary Mode - Basic Infusion (Continued) Auto-Restart The Auto-Restart 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 pressure falls to an acceptable level within a -second “Checking Line”...

  • Page 32: Secondary Mode

    Secondary Mode This mode is designed to support automatic secondary WARNINGS infusions (“piggybacking”) in the same instrument. When the • Secondary applications require secondary reaches zero, an audio tone will sound VTBI the use of a check valve set on indicating completion of the secondary infusion.
  • Page 33 Secondary Mode (Continued) Attach secondary administration set to upper injection site on primary set. Lower primary fluid container using hanger provided with secondary administration set. NOTE: The secondary container should be at least ½ inches above the top of the fluid level in the primary container.

  • Page 34: Changing Primary Infusion Parameter During Secondary Infusion

    Secondary Mode (Continued) 10. To enter secondary volume to be infused, press soft VTBI key and use numeric data entry keys. Infusion Setup 11. Open clamp on secondary administration set. SECONDARY RATE mL/h VTBI >Verify Secondary Clamp is Open, then Press START PAUSE START PRIMARY...

  • Page 35: Stopping Secondary Infusion And Returning To Primary Infusion

    Secondary Mode (Continued) Changing Primary Infusion Parameter During Secondary Infusion (Continued) Verify correct primary infusion parameters and press Infusion Setup soft key SECONDARY PRIMARY RATE mL/h • Secondary setup screen displays. VTBI >Press START SECOND- PAUSE START To resume secondary infusion, press soft key.

  • Page 36: Changing Primary Solution Container

    Secondary Mode (Continued) Stopping Secondary Infusion and Returning to Primary Infusion (Continued) To stop secondary infusion and begin infusing primary, Infusion Setup press Yes soft key. PRIMARY RATE mL/h • Secondary infusion stops and primary infusion begins. VTBI • Main screen appears. Stop Secondary and Infuse Primary? NOTE: The...

  • Page 37: Channel Labels

    Channel Labels Selecting Channel Label Press key. CHANNEL SELECT Press key. OPTIONS Press Channel Labels soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit - P Channel Labels >Select an Option or EXIT EXIT Press soft key for desired label. Channel Label Display Adult ICU 0.9% NaCl...

  • Page 38: Removing Channel Label

    Channel Labels (Continued) Removing Channel Label Press key. CHANNEL SELECT Press key. OPTIONS Press Channel Labels soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit - P Channel Labels >Select an Option or EXIT EXIT Press soft key.

  • Page 39: Powering Off

    Powering Off Reference the Medley ™ Point-of-Care Unit for the following procedures: Powering Off System Powering Off Module Setting Up Drug Calculation The drug calculation can be set up for a drug stored in the WARNING Guardrails ® Drug Library or for a non-library drug, as The Drug Calculation feature is to described in the following sections.

  • Page 40: Using Guardrails Drug Library

    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: • Bolus dose = bolus dose x patient weight (if used). • Bolus dose administration rate ( INFUSE AT: When duration is entered = total dose / duration in minutes.
  • Page 41 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) Perform steps in “Preparing Infusion” section, to prime and load primary administration set. Press key. CHANNEL SELECT Press Guardrails Drug Library soft key. Infusion Menu Guardrails Drug Library Basic infusion >Select an Option or EXIT EXIT RESTORE...
  • Page 42 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) • If Yes was selected to continue programming, drug Guardrails Drug Library Lidocaine amount and diluent volume (if defined in Guardrails ® DRUG gram AMOUNT Drug Library) are automatically entered for selected DILUENT VOLUME drug.
  • Page 43 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) Guardrails Drug Library To enter volume to be infused, press soft key and VTBI A A A Lidocaine use numeric data entry keys. CONTINUOUS INFUSION RATE 67.5 mL/h NOTES: VTBI •...

  • Page 44: Using Non-Library Drug

    Setting Up Drug Calculation (Continued) 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...
  • Page 45 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) To enter container, use numeric data DRUG AMOUNT Drug Calculation entry keys. DRUG _ _ _ _ _ AMOUNT DILUENT VOLUME gram PATIENT WEIGHT TIME unit UNITS DOSING UNITS >Enter Amount of Drug in Container DRUG LIBRARY...
  • Page 46 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 10. To indicate whether or not patient weight is to be used in Drug Calculation Drug Calculation, press either Yes or No soft key. DRUG AMOUNT DILUENT VOLUME NOTE: Do not enter a patient weight if weight is not used in PATIENT >...
  • Page 47 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 14. Press soft key next to desired DOSING UNITS Drug Calculation DRUG AMOUNT DILUENT VOLUME PATIENT WEIGHT TIME mcg/kg/min UNITS DOSING > > mg/kg/min UNITS [Conc]: 1000 mcg/mL >Select the Desired Dosing Units DRUG LIBRARY...

  • Page 48: Bolus Dose

    Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 18. Verify parameters are correct and press soft key. START Midtown Hospital Adult ICU VTBI = 250 mL VOLUME AUDIO INFUSED ADJUST Bolus Dose A bolus dose can be programmed at the beginning of, or during, an infusion.
  • Page 49 Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) Weight-based example. Guardrails Drug Library A A A Heparin CONTINUOUS INFUSION RATE 20.0 mL/h VTBI DOSE unit/kg/h [Conc]: 10 units/mL >Press START PAUSE SETUP BOLUS START • is highlighted. DOSE NOTES: •...
  • Page 50 Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) • If programmed continuous dose is weight-based, Guardrails Drug Library A A A Heparin programmed weight displays (as in illustrated example, BOLUS DOSE which reflects use of Heparin in Pediatrics _ _ _ _ unit/kg DOSE...
  • Page 51 Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) • When continuous dose is weight-based: Guardrails Drug Library a. Press soft key. SETUP A A A Heparin BOLUS DOSE _ _ 50 unit/kg DOSE PATIENT WEIGHT DURATION TOTAL DOSE = 500 units [Conc]: 10 units/mL >Select DURATION SETUP...
  • Page 52 Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) e. Press soft key. BOLUS Guardrails Drug Library A A A A A A Heparin CONTINUOUS INFUSION 20.0 RATE mL/h VTBI 18.18 DOSE unit/kg/h [Conc]: 10 units/mL >Press START BOLUS PAUSE SETUP START...

  • Page 53: Using Non-Library Drug Calculation

    Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) Verify parameters are correct and press soft key. Guardrails Drug Library START Guardrails Drug Library A A A A A A Lidocaine Dopamine BOLUS DOSE BOLUS DOSE NOTE: If a continuous dose outside of the Guardrails ®...
  • Page 54 Bolus Dose (Continued) Using Non-Library Drug Calculation (Continued) To enter bolus dose, use numeric data entry keys. A A A Drug Calculation BOLUS DOSE NOTE: After a bolus dose and weight (if used) are entered, _ _ 500 mcg/kg DOSE bolus and concentration [conc] alternate in the Main VTBI...

  • Page 55: Stopping Bolus Dose

    Bolus Dose (Continued) 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.

  • Page 56: Restoring Bolus Dose

    Bolus Dose (Continued) Restoring Bolus Dose A bolus dose can be restored after it has completed, either prior to or after the module has been turned off, as indicated in the following sections. NOTE: The display examples in this section represent restoring a bolus dose which was programmed using the Guardrails ®...
  • Page 57 Bolus Dose (Continued) Restoring Bolus Dose (Continued) Bolus Dose Completed - Module Turned Off Press key. CHANNEL SELECT Press soft key. RESTORE Infusion Menu Guardrails Drug Library Basic infusion >Select an Option or EXIT EXIT RESTORE Verify parameters and press soft key.

  • Page 58: Anesthesia Mode

    Bolus Dose (Continued) Restoring Bolus Dose (Continued) Bolus Dose Completed - Module Turned Off (Continued) Verify dosing parameters and press soft key. START Guardrails Drug Library Guardrails Drug Library A A A A A A Lidocaine Dopamine BOLUS DOSE BOLUS DOSE DOSE DOSE mcg/kg...

  • Page 59: Enabling Anesthesia Mode

    Anesthesia Mode (Continued) • Callback audio for paused modules is permanently silenced. • Review of drug calculation setup page is omitted when restoring a stopped drug calculation. Enabling Anesthesia Mode From Main Display, press key. OPTIONS Press Anesthesia Mode soft key. System Options 1 of 3 Display Contrast Patient ID...

  • Page 60: Disabling Anesthesia Mode

    Anesthesia Mode (Continued) Disabling Anesthesia Mode The Anesthesia Mode can be disabled, and normal operation resumed, using either of the following methods: • System Options menu. • Disconnecting system from power. • Connecting system to power. From System Options Menu While operating in Anesthesia Mode, press key.

  • Page 61: Delay Options

    Anesthesia Mode (Continued) Disabling Anesthesia Mode (Continued) Disconnecting System from AC Power While in Anesthesia Mode (Continued) Press soft key. CONFIRM Anesthesia mode was discontinued when AC power cord was disconnected. Press CONFIRM to continue normal operation. CONFIRM Connecting System to AC Power While in Anesthesia Mode Connect system to power.

  • Page 62: Delaying Infusion

    Delay Options (Continued) 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...
  • Page 63 Delay Options (Continued) Delaying Infusion (Continued) Specifying by Minutes (Continued) Press soft key. CONFIRM Delay Options 08:00 Pause Delay for minutes Delay until CALL None BACK >Select Callback or Press CONFIRM BACK CONFIRM • Delay period counts down on Main Display. Midtown Hospital 08:00 Adult ICU...
  • Page 64 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 minute and up to hours minutes. Press soft key. DELAY OPTIONS Infusion Setup RATE mL/h VTBI >Press START...
  • Page 65 Delay Options (Continued) Delaying Infusion (Continued) Specifying by Time of Day (Continued) Press soft key. CONFIRM Delay Options 08:00 Pause Delay for _ 9:00 Delay until CALL None BACK >Select Callback or Press CONFIRM BACK CONFIRM • Time infusion is scheduled to start appears on Main Midtown Hospital 08:00 Adult ICU...

  • Page 66: Scheduling A Callback

    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 types of callback: • Before - gives an alert when delay is completed and infusion needs to be initiated. •...
  • Page 67 Delay Options (Continued) Scheduling a Callback (Continued) • If Delay until programming, time infusion is scheduled Midtown Hospital 08:00 Adult ICU to start appears on Main Display. Start at 09:00 VOLUME AUDIO INFUSED ADJUST • If Delay for programming, delay period counts down Midtown Hospital 08:00 Adult ICU...

  • Page 68: Pausing Infusion

    Delay Options (Continued) Scheduling a Callback (Continued) To respond to a callback: • Before callback Press key and then soft key. CHANNEL SELECT START Press key. RESTART • After callback Press soft key. CONFIRM • Before and After callback Respond as indicated above for both Before and After.

  • Page 69: Multidose Mode

    Delay Options (Continued) Pausing Infusion (Continued) Press soft key. CONFIRM Delay Options 09:30 Pause • scrolls in Message Display. PAUSE Delay for • appears on Main Display. PAUSED Delay until CALL BACK • Yellow Standby Status Indicator illuminates. • After minutes: visual PAUSE...

  • Page 70: Programming With Volume/Duration Enabled

    Multidose Mode (Continued) 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. Perform steps in “Start-Up” section, to: a. Power on system. b.
  • Page 71 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) Press Multidose soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit - P Channel Labels >Select an Option or EXIT EXIT If Current time displayed is correct, press soft CONFIRM Multidose...
  • Page 72 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) 10. To enter duration for each dose, press soft key DURATION Multidose 13:00 and use numeric data entry keys. RATE = _ _ _ mL/h VOLUME/ DOSE NOTE: is calculated with each keystroke for RATE _ _ _ _ DURATION...
  • Page 73 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) 13. To begin multidose infusion, press soft key. START Multidose 13:00 RATE = mL/h VOLUME/ DOSE 00 30 DURATION DOSE every INTERVAL # OF doses DOSES >Press START DELAY RATE START OPTIONS VOLUME...

  • Page 74: Programming With Volume/Duration Disabled

    Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) • Between infusions: Multidose 12:00 Rate = mL/h Number of doses completed and when next dose ♦ Volume/ Dose starts display. 00 30 Duration = Yellow Standby Status Indicator illuminates. ♦...
  • Page 75 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) Press key. OPTIONS Infusion Setup _ _ _ RATE mL/h _ _ _ _ VTBI >Select Rate or Restore Previous Infusion VOLUME RESTORE DURATION Press Multidose soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose Pressure Limit - P...
  • Page 76 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) To enter time interval ( hours) between doses, Multidose 13:00 press soft key and use numeric data DOSE INTERVAL RATE mL/h entry keys. VOLUME/ DOSE DOSE every INTERVAL # OF DOSES >Enter Dose Interval 10.

  • Page 77: Reviewing Serial Number

    Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) • At completion of a multidose program, Midtown Hospital MULTIDOSE 8:00 Adult ICU appears on Main Display. COMPLETE MULTIDOSE COMPLETE AUDIO VOLUME ADJUST INFUSED 12. To see detail screen during or between infusions, press key.
  • Page 78 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K Pump Module, 8100 Series PROGRAMMING Directions for Use...

  • Page 79: Alarms, Errors, Messages

    ALARMS, ERRORS, MESSAGES To enhance safety and ease of operation, the Medley ™ System provides a full range of audio and visual alarms, errors, and messages. Definitions Reference the Medley ™ Point-of-Care Unit Directions for Use Audio Characteristics Reference the Medley ™...

  • Page 80: Errors

    Alarms (Continued) Alarm Meaning Response Flo-Stop Open - Close Door Flo-Stop ® Device is in open position Close roller clamp on while door is open. administration set or close door. Indicates either upstream occlusion Clear occlusion on fluid side of Occluded - Fluid Side/Empty Container or empty container.

  • Page 81: Messages

    Messages Message Meaning Response Anesthesia Mode Anesthesia Mode discontinued Press soft key. CONFIRM when disconnected from Module running in continuous Bolus Dose Complete None infusion mode if programmed. Checking Line Patient-side occlusion occurred; None Auto-Restart feature monitoring downstream pressure to determine if infusion can continue.
  • Page 82 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K Pump Module, 8100 Series ALARMS, ERRORS, MESSAGES Directions for Use...

  • Page 83: Specifications

    MAINTENANCE The Medley ™ System Technical Service Manual is available from Medical Systems. It includes ALARIS routine service schedules, interconnect diagrams, component parts lists and descriptions, test procedures, and other technical information, to assist qualified service personnel in repair and maintenance of the instrument’s repairable components.
  • Page 84 Specifications (Continued) Fluid Ingress Protection: , Drip Proof IPX1 Infusion of Air, Means to Protect Patient from: Ultrasonic Air-in-Line Detection Maximum single bolus size = selectable microliters nominal ( microliters in Anesthesia Mode) Infusion Pressure, Maximum: mmHg (Maximum Occlusion Alarm Threshold plus tolerance) KVO (Keep Vein Open) Rate: Factory Default Setting is...

  • Page 85: Configurable Settings

    Specifications (Continued) Time to Alarm, Maximum: Pressure Limit (mmHg) Rate (mL/h) ≤5 minutes ≤45 minutes ≤15 seconds ≤2 minutes Volume to be Infused Range Increments Programming Increments: (mL) (mL) 0.1 - 9.99 0.01 10 - 999.9 1000 - 9999 Weight: 2.5 lbs NOTE: Compliance to Standards The Medley...

  • Page 86: Shared Infusion Settings (Pump Module And Syringe Module)

    Configurable Settings (Continued) Shared Infusion Settings (Pump Module and Syringe Module) Feature Default Setting Options Delay Options Disabled Enabled - Disabled • Callback None None, Before, After, Before and After Drug Calculation Disabled Enabled - Disabled • Bolus Dose Disabled Enabled - Disabled Multidose Disabled...

  • Page 87: Cleaning

    Cleaning Reference the Medley ™ Point-of-Care Unit ( Inspection Requirements To ensure the system remains in good operating condition, WARNING both regular and preventive maintenance inspections are Failure to perform these inspections required. Reference the Medley ™ Maintenance Software/User may result in improper instrument Manual (Model , or later) for detailed instructions.

  • Page 88: Warranty

    Medical Systems ® ALARIS 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. See packing inserts for international warranty, if applicable. Pump Module, 8100 Series...

  • Page 89: Appendix

    APPENDIX Trumpet and Start-Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET uniformity. Trumpet curves are derived from AND START-UP CURVES the second hour of this data. In this instrument, as with all infusion systems, FLOW CHARACTERISTICS UNDER VARYING the action of the pumping mechanism and DELIVERY CONDITIONS variations in individual administration sets Effects of Pressure Variations...
  • Page 90 Trumpet and Start-Up Curves (Continued) Start-Up at 1 mL/h (initial) Start-Up at 0.1 mL/h (initial) Time (min) Time (min) Trumpet Curve at 0.1 mL/h (initial) Trumpet Curve at 0.1 mL/h (initial) Trumpet Curve at 1 mL/h (initial) Observation Interval (min) Observation Interval (min) Trumpet Curve at 0.1 mL/h (72 hrs) Trumpet Curve at 0.1 mL/h (72 hrs)
  • Page 91 Trumpet and Start-Up Curves (Continued) Start-Up at 25 mL/h (initial) Start-Up at 999 mL/h (initial) Time (min) Time (min) Trumpet Curve at 25 mL/h (initial) Trumpet Curve at 999 mL/h (initial) Observation Interval (min) Observation Interval (min) Trumpet Curve at 25 mL/h (72 hrs) Trumpet Curve at 999 mL/h (24 hrs) Observation Interval (min) Observation Interval (min)
  • Page 92 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K Pump Module, 8100 Series APPENDIX Directions for Use...
  • Page 94 SE, UK). EP0748635B1 (AT, BE, CH, DK, FI, FR, GR, IE, IT, LU, MC, NL, PT, SE, UK). EP0686405 (BE, FR, IT, LU, NL, SE, UK). EP0649316 (DK). EP0238227 (FR, UK). EP0422855 (FR, UK). EP0431310 (FR, UK). Other Patents Pending 10010716 Rev00 ©2003, 2004 ALARIS Medical Systems, Inc. All Rights Reserved Pump Module, 8100 Series...

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