Alaris Medical Systems Medley 8110 Directions For Use Manual
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Alaris Medical Systems Medley 8110 Directions For Use Manual

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Summary of Contents for Alaris Medical Systems Medley 8110

  • Page 3: Table Of Contents

    TABLE O O F C C ONTENTS INTRODUCTION ABOUT THE SYSTEM ..................FEATURES AND DEFINITIONS .
  • Page 4 GETTING STARTED (Continued) PROGRAMMING BOLUS DOSE ................Using Guardrails ®...
  • 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™ Syringe Module. Read all instructions, for both the Syringe Module and Programming Module, before using the Medley™ System. The Medley™ Syringe Module uses standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps.

  • 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. ALL Mode When is selected as the volume to be infused ( ), the VTBI entire contents of the syringe will be delivered.
  • Page 10 Features and Definitions (Continued) Drug Calculation The Drug Calculation mode allows: • entry of drug dose (Medley™ System calculates correct flow rate to achieve desired dose), • entry of flow rate (Medley™ System calculates corresponding drug dose). Dynamic Pressure Display The Dynamic Pressure Display appears on the Main Display.
  • Page 11 Features and Definitions (Continued) Multidose Mode The Multidose Mode option allows doses to be programmed at equally spaced intervals on the same Syringe Module over a -hour period. This mode is designed to allow delivery of multiple, equal doses from the same syringe at regularly scheduled intervals.
  • Page 12 Features and Definitions (Continued) Selectable KVO The Selectable option allows some infusions to automatically switch into mode upon completion. The option setting cannot be changed after the instrument is powered on and a profile selected. Syringe Empty The instrument gives an alert and stops when an empty syringe is detected.

  • Page 13: 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 14 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 15: Getting Started

    GETTING S S TARTED 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 16 Warnings and Cautions (Continued) WARNING 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. WARNING The Guardrails ® Safety Software incorporates dosing limits and instrument configuration parameters based on hospital protocol.
  • Page 17 Warnings and Cautions (Continued) WARNING Use only standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps. The use of any other syringe or administration set may cause improper instrument operation, resulting in inaccurate fluid delivery or pressure sensing, or other potential hazards.
  • Page 18 Warnings and Cautions (Continued) WARNING Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient. 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 19 Warnings and Cautions (Continued) User Precautions To ensure proper performance of the Medley™ System and to reduce potential injury to the operator, observe the following precautions: • Disconnect from main ( ) power when performing maintenance. • The instrument case should only be opened by qualified service personnel using proper grounding techniques.
  • Page 20 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 21 Warnings and Cautions (Continued) User Precautions (Continued) Operating Environment DANGER Not for use in the presence of flammable anesthetics. Explosion risk if used in the presence of flammable anesthetics. 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...

  • Page 22: Controls And Indicators

    Controls and Indicators Gripper Control / Drive Head Release ( shown in closed position Status Indicators Plunger Grippers ( shown in closed position Alarm Infusing Standby (red) (green) (yellow) IUI Connector, Left Barrel Flange Grippers Rate Display Syringe Barrel Sensor Channel Message Display Channel Identification IUI Connector, Right...

  • Page 23: 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 into use. Unpacking Syringe Module Remove Syringe Module from its carton. Verify gripper control/drive head release, plunger grippers, and syringe barrel clamp/sizer operate freely and correctly.

  • Page 24: Displays

    Displays The displays illustrated throughout this document are for illustration purposes only. The display content will vary, depending on configuration settings, type of syringe and administration set in use, hospital-defined data set uploaded using the Guardrails ® Safety Software, programmed drug calculation parameters, and many other variables.

  • Page 25: 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 26: Preparing Infusion

    Preparing Infusion Preparing Syringe and Administration Set Prepare syringe (reference “Compatible Syringes” section in WARNING “Maintenance” chapter) in accordance with manufacturer’s Use only standard, single-use, directions for use. disposable syringes (with luer-lock connectors) and administration sets, Prepare administration set (reference Set Compatibility Card, designed for use on syringe pumps.
  • Page 27 Preparing Infusion (Continued) Loading Syringe and Administration Set (Continued) Open syringe barrel clamp. a. Pull syringe barrel clamp out and hold. b. Rotate clamp to left (clockwise or counter clockwise) until it clears syringe chamber. c. Gently release clamp. RATE (mL/h) CHANNEL SELECT Syringe Barrel Clamp Open...
  • Page 28 Preparing Infusion (Continued) Loading Syringe and Administration Set (Continued) Lock syringe in place. a. Pull syringe barrel clamp out and hold. b. Rotate clamp to right (clockwise or counter clockwise) RATE (mL/h) until it lines up with syringe. c. Gently release clamp against syringe. CHANNEL SELECT PAUSE...
  • Page 29 Preparing Infusion (Continued) Loading Syringe and Administration Set (Continued) Insert pressure sensing disc (if used), as follows: WARNING When the pressure sensing disc is not NOTE: The following are special Syringe Module features being used and an occlusion occurs, available only with extension sets fitted with a pressure there is a risk of infusing pressurized sensing disc: (Refer to the “Features and Definitions”...

  • Page 30: Selecting Syringe Type And Size

    Preparing Infusion (Continued) Selecting Syringe Type and Size At the start of an infusion program, the system prompts to WARNING select and confirm the syringe type and size. Ensure the displayed syringe manufacturer and size correctly NOTE: The system automatically detects the syringe size, and lists identifies the installed syringe.
  • Page 31 Preparing Infusion (Continued) Selecting Syringe Type and Size (Continued) To accept, press soft key. CONFIRM Syringe Selection BD 50 mL IVAC 50 mL MONO 50 mL >Confirm Syringe Size CONFIRM Press soft key next to applicable infusion type, 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 Infusion Menu or 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 .

  • Page 32: Priming

    Preparing Infusion (Continued) Priming The Priming option can be enabled at the time the Medley™ WARNING System is configured for use. The Priming selection ( soft PRIME When priming: key) is available only after the syringe and infusion type have •...
  • Page 33 Preparing Infusion (Continued) Priming (Continued) Press key. OPTIONS Press P P r r i i m m e e S S e e t t w w i i t t h h S S y y r r i i n n g g e e soft key. Channel Options 1 of 1 Guardrails Drug Library Multidose...
  • Page 34 Preparing Infusion (Continued) Priming (Continued) Pressure Sensing Disc Used/Installed (Continued) When priming is complete, release soft key. PRIME Prime Set with Syringe CAUTION: Do not prime with disposable set connected to patient! Prime Volume 2 mL >Press and Hold PRIME EXIT PRIME Syringe Module...
  • Page 35 Preparing Infusion (Continued) Priming (Continued) Pressure Sensing Disc Used/Installed (Continued) To return to main screen, press soft key. EXIT A A A • If soft key is pressed before pressure sensing disc is EXIT Re-install Pressure Sensing Disc. reinstalled, a prompt to reinstall pressure sensing disc displays.
  • Page 36 Preparing Infusion (Continued) Priming (Continued) Pressure Sensing Disc Not Used/Installed (Continued) Press and hold soft key until fluid flows and priming PRIME of syringe administration set is complete. Prime Set with Syringe CAUTION: Do not prime with disposable set NOTE: Fluid is delivered during priming only while the P P R R I I M M E E connected to patient! soft key is pressed.

  • Page 37: Basic Infusion

    Basic Infusion The following procedures should be used only when WARNING 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 . To program an infusion using When the pressure sensing disc is not the Guardrails ®...

  • Page 38: Starting Rate / Volume Infusion

    Basic Infusion (Continued) Starting Rate / Volume Infusion To enter flow rate, press soft key and use numeric data RATE Infusion Setup entry keys. _ _ _ mL/h RATE VTBI >Select RATE VOLUME DURATION To enter a numeric value (instead of infusing press VTBI Infusion Setup...

  • Page 39: Starting Volume / Duration Infusion

    Basic Infusion (Continued) Starting Rate / Volume Infusion (Continued) • At completion of infusion: Midtown Hospital Adult ICU An audio prompt sounds. ♦ Red Alarm Status Indicator flashes. ♦ option is enabled: ♦ Channel Rate Display changes to rate. scrolls in Channel Message INFUSION C C OMPLETE–KVO Display.
  • Page 40 Basic Infusion (Continued) Starting Volume / Duration Infusion (Continued) To enter a numeric value (instead of infusing press VTBI Infusion Setup soft key and use numeric data entry keys. VTBI _ _ _ mL/h RATE= VTBI DURATION _ _ h _ _ mm To deliver entire contents of syringe, leave VTBI NOTE: When ALL MODE is disabled, the VTBI ALL option is not...

  • Page 41: Possible End Of Infusion Messages And Alerts

    Basic Infusion (Continued) Starting Volume / Duration Infusion (Continued) • At completion of infusion: Midtown Hospital Adult ICU COMPLETE An audio prompt sounds. ♦ Red Alarm Status Indicator flashes. ♦ option is enabled: ♦ Rate Display changes to rate. scrolls in Channel Message INFUSION C C OMPLETE–KVO Display.

  • Page 42: Pausing Infusion

    Basic Infusion (Continued) Pausing Infusion IVAC 50 mL NOTE: To pause an infusion when Delay Options is enabled, 50 mL/h RATE reference “Delay Options”, “Pausing Infusion” section. VTBI Press key (on Syringe Module). PAUSE Press key and then press soft key (on CHANNEL S S ELECT PAUSE >Press START...

  • Page 43: Restarting Infusion Following Infusion Complete

    Basic Infusion (Continued) Restarting Infusion Following Infusion Complete If syringe requires replacement, reference “Preparing Infusion” section to: a. Remove existing syringe and prepare new syringe (reference “Preparing Syringe and Administration Set” section). b. Load syringe and administration set. c. Select syringe type and size. NOTE: Since the system is already in a basic infusion mode, the Infusion Menu screen does not appear after the syringe type and size are confirmed.

  • Page 44: Changing Rate Or Vtbi During Infusion

    Basic Infusion (Continued) Changing Rate or VTBI During Infusion Press key. CHANNEL S S ELECT Infusion Setup 50 mL/h RATE Press either soft key. RATE VTBI 40 mL VTBI >Press START VOLUME START PAUSE DURATION To enter desired parameter, use Up/Down Arrows for rate Infusion Setup titration, or numeric data entry keys.
  • Page 45 Basic Infusion (Continued) Selecting Pressure Limit (Continued) Pressure Sensing Disc Installed (Continued) 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 46: Viewing And Clearing Volume Infused

    Basic Infusion (Continued) Selecting Pressure Limit (Continued) Pressure Sensing Disc Not Installed (Continued) To select a pressure limit, press appropriate soft key (L L o o w w , M M e e d d , or H H i i g g h h ). Pressure Limit Selection Press soft key.

  • Page 47: Changing Syringe During Infusion

    Basic Infusion (Continued) Changing Syringe During Infusion To stop infusion, press key (on Syringe Module). PAUSE Open plunger grippers and syringe barrel clamp. • An audio prompt sounds (to silence, press key). SILENCE • Red Alarm Status Indicator flashes. • CHECK S S YRINGE scrolls in Channel Message Display.

  • Page 48: Channel Labels

    Channel Labels Selecting 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 49: 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 50: Setting Up Drug Calculation

    Setting 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 trained in the administration of...

  • Page 51: Using Guardrails Drug Library

    Setting Up Drug Calculation (Continued) Drug Calculation Parameters (Continued) • Continuous drug dose = Flow rate x Drug concentration (normalized for patient weight if specified by entering a patient weight). • Continuous flow rate = Drug dose / Drug concentration (normalized for patient weight if specified by entering a patient weight).
  • Page 52 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) Press soft key next to desired drug and concentration. Guardrails Drug Library Adult ICU Aminophylline 50mg/50mL NOTES: Bretylium 50 mg/25mL • To view additional drugs/concentrations, press a soft key Dobutamine ___mg/___mL next to a letter group to navigate through alphabet, and/or Dopamine 40mg/50mL...
  • Page 53 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) • If hospital practice guidelines identify selected drug as Guardrails Drug Library Heparin weight-based, prompt for a patient weight in kilograms DRUG 10000 units AMOUNT appears (as in illustrated example, which reflects use of DILUENT VOLUME Heparin in Pediatrics...
  • Page 54 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) Guardrails Drug Library A A A NOTE: When VTBI equals ALL , the A A L L L L soft key appears Lidocaine CONTINUOUS INFUSION inactive when the V V T T B B I I soft key is pressed and active when a value is entered.
  • Page 55 Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) Guardrails Drug Library NOTE: If the programmed continuous dose infusion is outside Lidocaine Dose exceeds Reprogram the Guardrails ® Hard Limit for that care area, a prompt Guardrails hard appears before programming can continue.

  • Page 56: Using Non-Library Drug

    Setting Up Drug Calculation (Continued) Using Guardrails ® Drug Library (Continued) option is disabled, and: ♦ Syringe is not empty: scrolls in INFUSION C C OMPLETE Channel Message Display and appears on COMPLETE Main Display. Syringe is empty: scrolls in Channel SYRINGE E E MPTY Message Display and appears on Main Display.

  • Page 57: Getting Started (Continued)

    Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) To enter in syringe, use numeric data entry DRUG A A MOUNT Drug Calculation keys. DRUG _ _ _ _ _ AMOUNT DILUENT VOLUME gram PATIENT WEIGHT TIME unit UNITS DOSING UNITS >Enter Amount of Drug in Container...
  • Page 58 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) To indicate whether or not patient weight is to be used in Drug Calculation Drug Calculation, press either Y Y e e s s or N N o o soft key. DRUG AMOUNT DILUENT...
  • Page 59 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 12. Press soft key next to desired DOSING U U NITS Drug Calculation DRUG AMOUNT DILUENT VOLUME PATIENT WEIGHT TIME mcg/kg/min UNITS DOSING > > mg/kg/min UNITS [Conc]: 5000 mcg/mL >Select the Desired Dosing Units DRUG LIBRARY...
  • Page 60 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 15. To enter volume to be infused, press soft key and use VTBI A A A Drug Calculation numeric data entry keys. CONTINUOUS INFUSION RATE mL/h NOTE: The B B O O L L U U S S soft key appears only if Bolus Dose is _ _ _ _ VTBI enabled within the selected profile and a VTBI is entered.
  • Page 61 Setting Up Drug Calculation (Continued) Using Non-Library Drug (Continued) 16. Verify parameters are correct and press soft key. START A A A Drug Calculation CONTINUOUS INFUSION • During infusion: RATE mL/h Green Infusing Status Indicator illuminates. ♦ VTBI Rate appears in Channel Rate Display. DOSE mcg/kg/min ♦...

  • Page 62: Programming Bolus Dose

    Programming Bolus Dose A bolus dose can be programmed at the beginning of, or during, an infusion. The drug being programmed must be a bolusable drug selected from the Guardrails ® Drug Library or a non-library drug, as described in the following sections. NOTES: •...
  • Page 63 Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) • is highlighted. DOSE NOTES: • If the programmed continuous dose infusion is outside the Guardrails ® Soft Limit for that care area, a prompt appears before programming can continue. If the Yes soft key is pressed, programming continues;...
  • Page 64 Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) To enter or change patient weight (if used), use applicable following procedure, depending on whether or not continuous dose is weight-based. • When continuous dose is not weight-based: a. Press soft key.
  • Page 65 Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) Guardrails Drug Library b. Press soft key. PATIENT W W EIGHT Heparin DRUG 10000 units AMOUNT DILUENT VOLUME PATIENT WEIGHT TIME Hour UNITS DOSING units/kg/h UNITS [Conc]: 200 units/mL >Press NEXT to Confirm DRUG NEXT...
  • Page 66 Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) To enter bolus dose, use numeric data entry keys. Guardrails Drug Library A A A Heparin BOLUS DOSE _ _ _ _ unit/kg DOSE PATIENT WEIGHT DURATION [Conc]: 200 units/mL >Enter Bolus Dose SETUP Press...
  • Page 67 Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) Main Display alternates between Bolus and drug Midtown Hospital ♦ VTBI Adult ICU name with dose. BOLUS VTBI = 17.8 mL When continuous infusion is close to being ♦ completed and is enabled: NEOI...

  • Page 68: Using Non-Library Drug Calculation

    Programming Bolus Dose (Continued) Using Guardrails ® Drug Library Calculation (Continued) • At completion of continuous infusion: An audio prompt sounds. ♦ Red Alarm Status Indicator flashes. ♦ option is enabled: ♦ Rate Display changes to rate. scrolls in Channel Message INFUSION C C OMPLETE–KVO Display.
  • Page 69 Programming Bolus Dose (Continued) Using Non-Library Drug Calculation (Continued) To enter bolus duration, use numeric data entry keys. A A A Drug Calculation BOLUS DOSE 2000 DOSE To deliver bolus dose at maximum rate possible for selected PATIENT Not Used (999 mL/h) WEIGHT profile and setup, and automatically calculate bolus...

  • Page 70: Stopping Bolus Dose

    Programming Bolus Dose (Continued) Using Non-Library Drug Calculation (Continued) • At completion of bolus infusion: System beeps twice. ♦ scrolls in Channel Message BOLUS D D OSE C C OMPLETE ♦ Display. NOTE: If the bolus dose infusion is not followed immediately by a continuous dose infusion, B B O O L L U U S S C C O O M M P P L L E E T T E E appears on the Main Display.

  • Page 71: 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 = 17.8 mL >Press START to Continue Infusing Bolus Dose STOP...
  • Page 72 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 mL/h VTBI DOSE...
  • Page 73 Programming Bolus Dose (Continued) Restoring Bolus Dose (Continued) Bolus Dose Completed - Channel Turned Off (Continued) Verify parameters and press soft key. NEXT Guardrails Drug Library Lidocaine DRUG gram AMOUNT DILUENT VOLUME PATIENT Not Used WEIGHT TIME UNITS DOSING mg/min UNITS [Conc]: 20 mg/mL >Press NEXT to Confirm...

  • Page 74: 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 75: 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 76 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 77: 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 78 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 Delay for _ _ _ minutes Delay until CALL BACK >Enter Delay Time...
  • Page 79 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 IVAC 50 mL minimum of one minute and up to hours...
  • Page 80 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 81: 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 82 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 83: 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 84: Multidose Mode

    Delay Options (Continued) Pausing Infusion (Continued) To reinitiate infusion: IVAC 50 mL 40 mL/h RATE • Press key. RESTART VTBI • Press key and then soft key. CHANNEL S S ELECT START >Press START DELAY VOLUME START OPTIONS DURATION Multidose Mode WARNINGS NOTES: •...
  • Page 85 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) Perform steps in “Preparing Infusion” section, to: a. Prepare syringe and administration set. b. Load syringe and administration set. c. Select syringe type and size (and 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 as infusion type).
  • Page 86 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) To enter volume to be infused for each dose, use numeric Multidose 08:00 data entry keys. _ _ _ RATE = mL/h VOLUME/ _ _ _ _ DOSE DURATION DOSE INTERVAL # OF DOSES...
  • Page 87 Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) 11. To begin multidose infusion, press soft key. START Multidose 08:00 RATE = mL/h VOLUME/ DOSE 00 30 DURATION DOSE every INTERVAL # OF doses DOSES >Press START RATE PAUSE START VOLUME •...

  • Page 88: Programming With Volume/Duration Disabled

    Multidose Mode (Continued) Programming with Volume / Duration Enabled (Continued) • Between infusions: Multidose 08:35 Rate = Number of doses completed and when next dose mL/h ♦ Volume/ starts display. Dose 00 30 Duration = Yellow Standby Status Indicator illuminates. ♦...
  • Page 89 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) To enter rate, use numeric data entry keys. Multidose 08:00 _ _ _ _ RATE mL/h VOLUME/ DOSE DOSE INTERVAL # OF DOSES >Enter Rate To enter volume to be infused for each dose, press Multidose 08:00 soft key and use numeric data entry keys.
  • Page 90 Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) To begin multidose infusion, press soft key. START Multidose 08:00 RATE mL/h VOLUME/ DOSE DOSE every INTERVAL # OF doses DOSES >Press START START PAUSE Midtown Hospital • Main Display shows remaining for that dose.

  • Page 91: Reviewing Serial Number

    Multidose Mode (Continued) Programming with Volume / Duration Disabled (Continued) • Between infusions: Multidose 08:35 Rate = mL/h Number of doses completed and when next dose ♦ Volume/ starts displays. Dose Yellow Standby Status Indicator illuminates. ♦ every doses Doses completed = 14:00 Dose Starts...
  • 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 GETTING STARTED...

  • Page 93: 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 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 94: 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 95: Alarms

    Alarms Alarm Meaning Response Channel Disconnected Channel(s) disconnected while in To silence alarm and clear message operation or have a communication from screen, press soft key. CONFIRM problem. Reattach channel if desired, ensuring it is securely “clicked” into place at Channel Release Latch.

  • Page 96: Syringe Adjustment Alarms

    Alarms (Continued) Syringe Adjustment Alarms When a syringe installation problem is detected, a visual signal is Drug Calculation A A A Heparin displayed. Text in the display blinks to indicate the location of CONTINUOUS INFUSION Syringe Installation the problem. lever plunger flange clamp...

  • Page 97: Errors

    Errors Error Meaning Response Channel Error Error detected. Operation stops on To silence alarm and continue affected channel. operation of unaffected channels, press soft key. Replace CONFIRM channel with an operational instrument, as required. Service by qualified personnel is required. Syringe Calibration Required Error on infusing channel indicating To silence alarm and continue...
  • Page 98 Messages (Continued) Message Meaning Response Panel Locked Tamper Resist feature is active and a If appropriate, deactivate Tamper key was pressed. Resist feature using Tamper Resist Control on back of Programming Module. Tamper Resist feature deactivated. Panel Unlocked None. Pause control pressed; infusion Pause To resume infusion, press RESTART...

  • Page 99: 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 100 Specifications (Continued) Flow R R ate P P rogramming: The flow rate range is from mL/h and can be selected as follows: 0.01 Flow Rates (mL) Selectable Increments (mL/h) 0.01 9.99 0.01 99.9 Rate Restriction by Syringe Size: Syringe Size (mL) Flow Rate Range (mL/h) 0.01 0.01...
  • Page 101 Specifications (Continued) Rate A A ccuracy: Rate accuracy of the Medley™ Syringe Module is of full scale plunger travel (not ±2% including syringe variation). WARNING Syringe size and running force, variations of back pressure, or any combination of these may affect rate accuracy. Factors that can influence back pressure are: Administration set configuration, solution viscosity, and IV solution temperature.

  • Page 102: Configurable Settings

    Configurable Settings If the configuration settings need to be changed from the "Factory Default" settings, refer to the applicable Technical Service Manual or contact Medical Systems, Technical ALARIS Support, for technical, troubleshooting, and preventive maintenance information. NOTE: With the Profiles feature enabled, the settings are configured independently for each profile.

  • Page 103: Syringe Module Settings

    Configurable Settings (Continued) Syringe Module Settings Feature Default Setting Options Auto Pressure Disabled Enabled - Disabled Back Off After Occlusion Enabled Enabled - Disabled Fast Start Enabled Enabled - Disabled KVO ( Disabled Enabled - Disabled “Keep Vein Open” • Rate Adjust 1 mL/h 0.1 - 2.5 mL/h •...

  • Page 104: 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 105: Warranty

    Systems any other liability in connection with the sale or use of Medical Systems ® Products. ALARIS 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. MAINTENANCE...
  • Page 106 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 107: Appendix

    APPENDIX Trumpet and Start-Up Curves In this instrument, as with all infusion systems, Because the clinical impact of short-term the action of the pumping mechanism and fluctuations on rate accuracy depends on the variations in individual syringes and half-life of the drug being infused and on the administration sets cause short-term fluctuations degree of intravascular integration, the clinical in rate accuracy.
  • Page 108 Trumpet and Start-Up Curves (Continued) Start-Up Curve at 5 mL/h (initial) 1 g/mL Start-Up Curve at 1 mL/h (initial) 1 g/mL Time (min) Time (min) Trumpet Curve at 5 mL/h (initial) Trumpet Curve at 1 mL/h (initial) -0.7 -1.4 -0.3 -1.8 -1.3 -0.9...
  • Page 110 , ALARIS Medical Systems , Guardrails , and Medley™ are trademarks and registered trademarks of ALARIS Medical Systems, Inc. All other trademarks belong to their respective owners. US Pat. Nos. 5,601,445; 5,713,856; 5,836,910; 5,941,846; AU Patent Nos. 693,662; 703,178; 703,203; 728,366; TW Patent No. NI–107963. Other...

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