Alaris Medical Systems MEDLEY 8220 Directions For Use Manual
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Alaris Medical Systems MEDLEY 8220 Directions For Use Manual

Medication safety system pump module
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Summary of Contents for Alaris Medical Systems MEDLEY 8220

  • Page 3: Table Of Contents

    TABLE OF CONTENTS INTRODUCTION ABOUT THE SYSTEM ..................FEATURES AND DEFINITIONS .
  • Page 4 GETTING STARTED (Continued) SETTING UP DRUG CALCULATION ............... . . Drug Calculation Parameters .
  • Page 5 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:...
  • Page 6 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...

  • Page 7: Introduction

    INTRODUCTION About the System 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 ( Series), the Guardrails ®...
  • Page 8 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.

  • Page 9: Features And Definitions

    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 The AutoRestart feature is part of the Medley™ System’s advanced Downstream Occlusion Detection system.
  • Page 10 Features and Definitions (Continued) Guardrails ® Limit 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 ®...

  • Page 11: Symbols

    Symbols Canadian and Certification Mark: Products bearing this mark have been tested and U.S. certified in accordance with applicable and Canadian electrical safety and performance U.S. standards ( CSA C22.2 601.1 UL 2601-1 IEC 60601–2–24 Electrical Shock Protection Rating: Type , Defibrillation-proof Protection against fluid ingress: Drip Proof IPX1...
  • Page 12 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 INTRODUCTION...

  • Page 13: Getting Started

    GETTING STARTED NOTE: Although the Medley™ Medication Safety System is built 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™...
  • Page 14 Warnings and Cautions (Continued) WARNING The Guardrails ® Safety Software incorporates dosing limits and instrument configuration parameters based on hospital protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital. Qualified personnel must ensure the appropriateness of the drug dosing limits, the compatibility of the drugs, and the performance of each instrument, as part of the overall infusion.
  • Page 15 Warnings and Cautions (Continued) WARNING 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. WARNING The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common site may impede the flow of common “gravity only”...
  • Page 16 Warnings and Cautions (Continued) User Precautions (Continued) Administration Sets WARNING • For a list of compatible administration sets, refer to Set Use only Medley™ System/Gemini Compatibility Card (provided separately). Series administration sets. The use of any other set may cause improper •...
  • Page 17 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 monitoring system is not functioning under optimal conditions, these currents may appear as artifacts, simulating actual readings.
  • Page 18 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.

  • Page 19: Controls And Indicators

    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 Message Display Channel Identification Channel Select Key - When pressed, selects corresponding channel for infusion parameter entry and infusion setup.
  • Page 20 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 21: 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. Unpacking Pump Module Remove Pump Module from its carton. Verify door operates freely.

  • Page 22: Displays

    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.

  • Page 23: Dynamic Pressure Display

    Displays (Continued) Dynamic Pressure Display Midtown Hospital Adult ICU VTBI = 250.0 mL Dynamic Pressure Display Current operating pressure is indicated by solid bar. Patient-side occlusion pressure set point is indicated by tick mark. VOLUME AUDIO INFUSED ADJUST CAUTION Although the dynamic pressure display bars for the Medley™...

  • Page 24: Flo-Stop Device

    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 ®...

  • Page 25: Loading And Removing Primary Administration Set

    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.) ®...
  • Page 26 Preparing Infusion (Continued) Loading and Removing Primary Administration Set (Continued) Loading Administration Set (Continued) 1. Load upper tubing fitment. 2. Load Flo-Stop ® Fitment. 3. Firmly push tubing toward back of Air-in-Line Detector. Removing Administration Set Close roller clamp. Open Pump Module door. •...

  • Page 27: Setting Up Primary Administration Set For Gravity Infusion

    Preparing Infusion (Continued) Setting Up Primary Administration Set for Gravity Infusion Prime administration set (“Priming Primary Administration Set”). Adjust container to hang inches above patient’s vascular access device. Attach administration set to patient’s vascular access device. Adjust flow rate with administration set roller clamp. Primary Mode - Basic Infusion The following procedures should be used only when programming a B B a a s s i i c c I I n n f f u u s s i i o o n n .

  • Page 28: Starting Rate/Volume Infusion

    Primary Mode - Basic Infusion (Continued) Press B B a a s s i i c c I I n n f f u u s s i i o o n n soft key. Infusion Menu Guardrails Drug Library •...

  • Page 29: Starting Volume/Duration Infusion

    Primary Mode - Basic Infusion (Continued) Starting Rate / Volume Infusion (Continued) • During infusion: Midtown Hospital Adult ICU VTBI = 250.0 mL Green Infusing Status Indicator illuminates. ♦ Rate appears in Channel Rate Display. ♦ Remaining appears on Main Display. ♦...
  • Page 30 Primary Mode - Basic Infusion (Continued) Starting Volume / Duration Infusion (Continued) To enter volume duration, press soft key and use DURATION Infusion Setup numeric data entry keys. RATE = mL/h 1000 VTBI • Rate is automatically calculated. DURATION Attach administration set to patient’s vascular access device. >Select DURATION RATE VOLUME...

  • Page 31: Pausing Infusion

    Primary Mode - Basic Infusion (Continued) Pausing Infusion NOTE: To pause an infusion when Delay Options is enabled, reference “Delay Options”, “Pausing Infusion” section. Press key (on Pump Module). PAUSE Infusion Setup RATE mL/h VTBI Press key and then press soft key (on CHANNEL S S ELECT PAUSE...

  • Page 32: Restarting Infusion Following Infusion Complete

    Primary Mode - Basic Infusion (Continued) Restarting Infusion Following Infusion Complete 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. Press key. CHANNEL S S ELECT To restart infusion using stored parameters, press RESTORE Infusion Menu...

  • Page 33: Changing Rate Or Vtbi During Infusion

    Primary Mode - Basic Infusion (Continued) Changing Rate or VTBI During Infusion Press key. CHANNEL S S ELECT 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 34: Selecting Pressure Mode - Pump / Selectable

    Primary Mode - Basic Infusion (Continued) Selecting Pressure Mode - Pump / Selectable Press key. CHANNEL S S ELECT Press key. OPTIONS Press P P r r e e s s s s u u r r e e L L i i m m i i t t soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose...

  • Page 35: 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 I I NFUSED 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 channel.

  • Page 36: Autorestart

    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 pressure falls to an acceptable level within a -second “Checking Line”...

  • Page 37: Secondary Mode

    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 reaches zero, an audio tone will sound indicating VTBI use of a check valve set on the completion of the secondary infusion.
  • Page 38 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 9 ½ inches above the top of the fluid level in the primary container. Set up and start primary infusion (reference “Primary Mode - Basic Infusion”...
  • Page 39 Secondary Mode (Continued) 10. To enter secondary volume to be infused, press soft key VTBI and use numeric data entry keys. Infusion Setup SECONDARY RATE mL/h VTBI >Select VTBI 11. Open clamp on secondary administration set. Infusion Setup SECONDARY 12. Verify correct infusion parameters and press soft key.

  • Page 40: Changing Primary Infusion Parameter During Secondary Infusion

    Secondary Mode (Continued) Changing Primary Infusion Parameter During Secondary Infusion Press key. CHANNEL S S ELECT Press soft key. PRIMARY Infusion Setup SECONDARY RATE mL/h VTBI >Press START START PAUSE PRIMARY To change primary infusion parameter, press applicable soft Infusion Setup key ( ), and use numeric data entry keys.

  • Page 41: Stopping Secondary Infusion And Returning To Primary Infusion

    Secondary Mode (Continued) Stopping Secondary Infusion and Returning to Primary Infusion Press key. CHANNEL S S ELECT Press soft key. PRIMARY Infusion Setup SECONDARY Close clamp on secondary administration set. RATE mL/h 43.4 VTBI Disconnect secondary administration set from upper injection port.

  • Page 42: Changing Primary Solution Container

    Changing Primary Solution Container To stop infusion, press key (on Pump Module). PAUSE Close roller clamp. Remove empty solution container. Insert administration set spike into prepared fluid container, following accepted hospital procedure, and hang container inches above Pump Module. Press key.
  • Page 43 Channel Labels (Continued) Selecting Channel Label (Continued) Press soft key for desired label. Channel Label Display Adult ICU 0.9% NaCl NOTE: To view additional labels, press a soft key next to a 3% NaCl letter group to navigate through alphabet, and/or P P A A G G E E U U P P CVVHDF Dialysate and P P A A G G E E D D O O W W N N soft keys.

  • Page 44: Removing Channel Label

    Channel Labels (Continued) Removing Channel Label Press key. CHANNEL S S ELECT Press key. OPTIONS Press C C h h a a n n n n e e l l L L a a b b e e l l s s soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose...

  • Page 45: Powering Off

    Powering Off Refer to the Medley™ Programming Module Directions for Use to the following procedures: Powering Off System Powering Off Channel Setting Up Drug Calculation The drug calculation can be set up for a drug stored in the WARNINGS Guardrails ®...

  • Page 46: 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 A A T: When duration is entered = total dose / duration in minutes.
  • Page 47 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 S S ELECT Press G G u u a a r r d d r r a a i i l l s s D D r r u u g g L L i i b b r r a a r r y y soft key. Infusion Menu Guardrails Drug Library Basic infusion...
  • Page 48 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) • If Y Y e e s s 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 drug.
  • Page 49 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) To enter volume to be infused, press soft key and use Guardrails Drug Library VTBI A A A Lidocaine numeric data entry keys. CONTINUOUS INFUSION 67.5 RATE mL/h NOTES: _ _ _ _ VTBI _ _ _9...

  • Page 50: Using Non-Library Drug

    Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) • During infusion: Midtown Hospital Adult ICU VTBI = 250 mL Green Infusing Status Indicator illuminates. ♦ Rate appears in Channel Rate Display. ♦ Dose and drug name scroll in Channel Message ♦...
  • Page 51 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) Perform steps in “Preparing Infusion” section, to prime and load primary administration set. Press key. CHANNEL S S ELECT Press G G u u a a r r d d r r a a i i l l s s D D r r u u g g L L i i b b r r a a r r y y soft key. Infusion Menu Guardrails Drug Library Basic infusion...
  • Page 52 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) To enter diluent volume, use numeric data entry keys. Drug Calculation DRUG AMOUNT DILUENT _ _ _ _ VOLUME PATIENT WEIGHT TIME UNITS DOSING UNITS >Enter Diluent Volume DRUG LIBRARY Press soft key.
  • Page 53 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 12. Press soft key. TIME U U NITS Drug Calculation DRUG AMOUNT DILUENT VOLUME PATIENT _ _ 70 WEIGHT TIME UNITS DOSING UNITS [Conc]: 1000 mcg/mL >Select TIME UNITS DRUG LIBRARY 13.
  • Page 54 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 16. To make a rate or dose entry, press applicable soft key, RATE A A A Drug Calculation and use numeric data entry keys (other value is DOSE, CONTINUOUS INFUSION calculated and displayed). _ _ _ mL/h RATE...

  • Page 55: Programming Bolus Dose

    Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) Midtown Hospital • At completion of infusion: Adult ICU COMPLETE If infusion ends in ♦ An audio prompt sounds. Red Alarm Status Indicator flashes. Channel Rate Display changes to rate. INFUSION C C OMPLETE–KVO scrolls in Channel Message Display.

  • Page 56: Drug Library Calculation

    Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation Set up Drug Calculation as described in “Setting Up Drug Calculation”, “Using Guardrails ® Drug Library” section, but do not start infusion. Press soft key. BOLUS Nonweight-based example. Guardrails Drug Library A A A Lidocaine CONTINUOUS INFUSION...
  • Page 57 Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) 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.
  • Page 58 Programming Bolus Dose (Continued) Using Guardrails ® Drug Calculation (Continued) b. To enter patient weight, use numeric data entry keys. Guardrails Drug Library A A A Lidocaine BOLUS DOSE DOSE mg/kg _ _ _ PATIENT WEIGHT DURATION [Conc]: 8 mg/mL >Select DURATION SETUP -- OR --...
  • Page 59 Programming Bolus Dose (Continued) Using Guardrails ® Drug Calculation (Continued) Drug Calculation Guardrails Drug Library A A A NOTE: If a continuous infusion is running, a prompt Heparin Heparin Dose will recalculate CONTINUOUS INFUSION to confirm the weight change appears. based on new weight.
  • Page 60 Programming Bolus Dose (Continued) Using Guardrails ® Drug Calculation (Continued) To enter bolus duration, use numeric data entry keys. Guardrails Drug Library A A A Lidocaine BOLUS DOSE DOSE mg/kg To deliver bolus dose at maximum rate possible for selected PATIENT WEIGHT (999 mL/h)

  • Page 61: Using Non-Library Drug Calculation

    Programming Bolus Dose (Continued) Using Guardrails ® Drug Calculation (Continued) Guardrails Drug Library A A A NOTE: To see details during the bolus infusion, press the Lidocaine BOLUS DOSE C C H H A A N N N N E E L L S S E E L L E E C C T T key.
  • Page 62 Programming 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 VTBI and concentration [conc] alternate in the Main PATIENT...

  • Page 63: Stopping Bolus Dose

    Programming Bolus Dose (Continued) Using Non-Library Drug Calculation (Continued) A A A Drug Calculation NOTE: To see details during the bolus infusion, press the BOLUS DOSE C C H H A A N N N N E E L L S S E E L L E E C C T T key.

  • Page 64: Restoring Bolus Dose

    Programming Bolus Dose (Continued) Stopping Bolus Dose (Continued) Press soft key. Guardrails Drug Library STOP B B OLUS A A A Lidocaine BOLUS DOSE Dose Remaining: mg/kg Pt. Weight: (999 mL/h) Time Left: Rate TOTAL DOSE = 355 mg BOLUS VTBI = 44.4 mL >Press START to Continue Infusing Bolus Dose STOP...
  • Page 65 Programming Bolus Dose (Continued) Restoring Bolus Dose (Continued) Bolus Dose Completed - Channel Not Turned Off Press key. CHANNEL S S ELECT Verify infusion parameters and press soft key. BOLUS Guardrails Drug Library A A A Lidocaine CONTINUOUS INFUSION RATE 67.5 mL/h VTBI...
  • Page 66 Programming Bolus Dose (Continued) Restoring Bolus Dose (Continued) Bolus Dose Completed - Channel Turned Off (Continued) Verify parameters and press soft key. Guardrails Drug Library NEXT Lidocaine DRUG gram AMOUNT DILUENT VOLUME PATIENT Not Used WEIGHT TIME UNITS DOSING mg/min UNITS [Conc]: 8 mg/mL >Press NEXT to Confirm...

  • Page 67: Anesthesia Mode

    Anesthesia Mode When the Medley™ System is operating in Anesthesia Mode, a CAUTION channel can be paused indefinitely without an alarm. When the Medley™ System is set 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.

  • Page 68: Disabling Anesthesia Mode

    Anesthesia Mode (Continued) Enabling Anesthesia Mode (Continued) Press E E n n a a b b l l e e soft key. System Options Anesthesia Mode Press soft key. CONFIRM Enable Disable Pump Module Change Air Detection = microliters >Select an Option or Press CONFIRM CONFIRM Press C C h h a a n n n n e e l l S S e e l l e e c c t t key.
  • Page 69 Anesthesia Mode (Continued) Disabling Anesthesia Mode (Continued) From System Options Menu (Continued) Press D D i i s s a a b b l l e e soft key. System Options Anesthesia Mode Press soft key. CONFIRM Enable Disable • A A n n e e s s t t h h e e s s i i a a M M o o d d e e no longer appears on Main Display, indicating it has been disabled.

  • Page 70: Delay Options

    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.
  • Page 71 Delay Options (Continued) Delaying Infusion (Continued) Specifying by Minutes (Continued) To enter number of minutes (up to ) infusion is to be Delay Options 08:00 delayed for, use numeric data entry keys. Pause _ _ _ minutes Delay for Delay until CALL BACK >Enter Delay Time...
  • Page 72 Delay Options (Continued) Delaying Infusion (Continued) Specifying by Time of Day The D D e e l l a a y y u u n n t t i i l l option is used to program an infusion delay for a minimum of one minute and up to hours minutes.
  • Page 73 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 74: Scheduling A Callback

    Delay Options (Continued) Scheduling a Callback When programming a D D e e l l a a y y f f o o r r or D D e e l l a a y y u u n n t t i i l l infusion, a callback can be scheduled for that infusion.
  • Page 75 Delay Options (Continued) Scheduling a Callback (Continued) • If D D e e l l a a y y u u n n t t i i l l programming, time infusion is scheduled to Midtown Hospital 08:00 Adult ICU start appears on Main Display.

  • Page 76: Pausing Infusion

    Delay Options (Continued) Scheduling a Callback (Continued) To respond to a callback: • B B e e f f o o r r e e callback Press key and then soft key. CHANNEL S S ELECT START Press key. RESTART •...

  • Page 77: Multidose Mode

    Delay Options (Continued) Pausing Infusion (Continued) To reinitiate infusion: Infusion Setup RATE mL/h • Press key. RESTART VTBI • Press key and then soft key. CHANNEL S S ELECT START >Press START DELAY SECOND- START OPTIONS Multidose Mode WARNINGS NOTES: •...
  • Page 78 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) Perform steps in “Preparing Infusion” section, to prime and load primary administration set. Press key. CHANNEL S S ELECT Press B B a a s s i i c c I I n n f f u u s s i i o o n n soft key. Infusion Menu Guardrails Drug Library •...
  • Page 79 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) Press soft key. VOLUME D D URATION Multidose 13:00 RATE _ _ _ _ mL/h VOLUME/ DOSE DOSE INTERVAL # OF DOSES >Enter Rate VOLUME DURATION To enter volume to be infused for each dose, use numeric Multidose 13:00 data entry keys.
  • Page 80 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) 12. To enter number of doses, press soft key and use #OF D D OSES Multidose 13:00 numeric data entry keys. RATE = mL/h VOLUME/ DOSE • If Delay Options is enabled, soft key DELAY O O PTIONS 00 30...

  • Page 81: Programming With Volume/Duration Disabled

    Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) 14. To see detail screen during or between infusions, press Multidose 12:30 key. CHANNEL S S ELECT Rate = mL/h Volume/ Dose • During infusion, V V o o l l u u m m e e R R e e m m a a i i n n i i n n g g displays. 00 30 Duration = every...
  • Page 82 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) Press B B a a s s i i c c I I n n f f u u s s i i o o n n soft key. Infusion Menu Guardrails Drug Library •...
  • Page 83 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) To enter volume to be infused for each dose, press Multidose 13:00 soft key and use numeric data entry keys. VOLUME/DOSE RATE mL/h VOLUME/ _ _ _ _ DOSE DOSE INTERVAL # OF DOSES...
  • Page 84 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) Midtown Hospital • Main Display shows remaining for that dose. VTBI 13:00 Adult ICU VTBI = 50.0 mL AUDIO VOLUME INFUSED ADJUST • At completion of a multidose program, MULTIDOSE Midtown Hospital 8:00 Adult ICU...

  • Page 85: Reviewing Serial Number

    Reviewing Serial Number Refer to the Medley™ Programming Module Directions for Use. Reviewing Software Version Refer to the Medley™ Programming Module Directions for Use. GETTING STARTED...
  • Page 86 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 GETTING STARTED...

  • Page 87: Alarms, Errors, Messages

    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. Definitions 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 key.

  • Page 88: Audio Characteristics

    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 One short beep every two seconds Variable volume; can be silenced for two minutes.

  • Page 89: Alarms

    Alarms Alarm Meaning Response Accumulated Air-in-Line A large number of air bubbles Clear air from line. To continue smaller than current air-in-line limit infusion, press soft key and RESET has recently passed detector. then key. RESTART Air-in-Line Air has been detected in administration Ensure tubing is properly installed in set during an infusion.

  • Page 90: Errors

    Alarms (Continued) Alarm Meaning Response Restart Channel Door opened and closed during an Close door. Press key, or RESTART infusion. Infusion stops on affected press key and then CHANNEL SELECT channel. soft key. START Channel paused for 2 minutes. Press key, or press RESTART CHANNEL...
  • Page 91 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 and then soft key. START Secondary Secondary infusion in progress on None. When secondary =”...
  • 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 ALARMS, ERRORS, MESSAGES...

  • Page 93: Maintenance

    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 94 Specifications (Continued) Fluid I I ngress P P rotection: , Drip Proof IPX1 Infusion o o f A A ir, M M eans t t o Protect P P atient f f rom: Ultrasonic Air-in-Line Detection Maximum single bolus size = selectable microliters nominal ( microliters in Anesthesia Mode)

  • Page 95: Configurable Settings

    Specifications (Continued) Volume t t o b b e I I nfused Range Increments Programming I I ncrements: (mL) (mL) 9.99 0.01 999.9 1000 9999 Weight: 2.5 lbs 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 ;...

  • Page 96: 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 Enabled - Disabled • Bolus Dose Disabled Multidose Disabled...

  • Page 97: Cleaning

    Cleaning 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. R R e e g g u u l l a a r r i i n n s s p p e e c c t t i i o o n n s s consist of a visual inspection for damage WARNING and cleanliness, and performing the procedure described in the Failure to perform these inspections...

  • Page 98: Service Information

    Inspection Requirements (Continued) Seal and Mechanical Parts • Mechanism seal is not torn or worn. • Mechanical parts move freely, do not hang up or bind, and function properly. • Torsion Spring on door functions properly. Open Door and ensure Door Latch stays up and does not sag. P P e e r r i i o o d d i i c c i i n n s s p p e e c c t t i i o o n n s s of the hardware are required.

  • Page 99: Warranty

    WARRANTY Medical Systems, Inc., (hereinafter referred to as “ Medical Systems”) warrants that: ALARIS ALARIS A. Each new Medical Systems ® Medley™ Pump Module is free from defects in material and ALARIS workmanship under normal use and service for a period of one ( ) year from the date of delivery Medical Systems to the original purchaser.
  • Page 100 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 MAINTENANCE...

  • Page 101: Appendix

    APPENDIX Trumpet and Start-Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND FLOW CHARACTERISTICS UNDER VARYING START-UP CURVES DELIVERY CONDITIONS In this instrument, as with all infusion systems, Effects of Pressure Variations the action of the pumping mechanism and Under conditions of + mmHg pressure, the variations in individual administration sets cause Medley™...
  • Page 102 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 103 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 104 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 APPENDIX...
  • Page 106 IT Brevettato Vol. R.A. No. 0,225,158; JP Patent Nos. 1,816,872 ; 2,594,604 ; 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...

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