Transcription
Directions for UseALARMSTANDBY8100 SERIESPUMP INGPump Module, 8100 SeriesALARIS Medical Systems, Inc.Medley Medication Safety System
GENERAL CONTACT INFORMATIONCustomer Advocacy - North AmericaClinical and technical feedback.Phone: (800) 854-7128, Ext. 7812E-Mail: CustomerFeedback@alarismed.comTechnical Support - North AmericaMaintenance and service information support; troubleshooting.United States:Phone:(858) 458-6003(800) 854-7128, Ext. 6003Canada:Phone:Eastern: (800) 908-9918Western: (800) 908-9919Customer Care - North AmericaInstrument return, service assistance, and order placement.United States:Phone:(800) 482-4822Canada:Phone:(800) 387-8309
TABLE OF CONTENTSINTRODUCTIONABOUT THE PUMP MODULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124GETTING STARTEDWARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Guardrails Safety Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Epidural Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .OPERATING FEATURES, CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ATTACHING AND DETACHING MODULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Dynamic Pressure Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Selecting New Patient and Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Modifying Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PREPARING INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Flo-Stop Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Priming Primary Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Loading and Removing Primary Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Setting Up Primary Administration Set for Gravity Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . INGPRIMARY MODE - BASIC INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Starting Rate/Volume Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Starting Volume/Duration Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Restarting Infusion Following Infusion Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Changing Rate or VTBI During Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Stopping Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Selecting Pressure Mode - Pump / Selectable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Viewing and Clearing Volume Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Auto-Restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SECONDARY MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Changing Primary Infusion Parameter During Secondary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Stopping Secondary Infusion and Returning to Primary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CHANGING PRIMARY SOLUTION CONTAINER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CHANNEL LABELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Selecting Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Removing Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Powering Off Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pump Module, 8100 SeriesDirections for Use1920212223242425262728303132333334353535TABLE OF CONTENTSi
PROGRAMMING (Continued)SETTING UP DRUG CALCULATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Drug Calculation Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Using Guardrails Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Using Non-Library Drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .BOLUS DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Using Guardrails Drug Library Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Using Non-Library Drug Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Stopping Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Restoring Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ANESTHESIA MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Enabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Disabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DELAY OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Delaying Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Scheduling a Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .MULTIDOSE MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Programming with Volume/Duration Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Programming with Volume/Duration Disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .REVIEWING SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .REVIEWING SOFTWARE VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .353536404444495152545556575862646566707373ALARMS, ERRORS, MESSAGESDEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7575757677MAINTENANCESPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Shared Infusion Settings (Pump Module and Syringe Module) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pump Module Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .798181828283838384APPENDIXTRUMPET AND START-UP CURVESii TABLE OF CONTENTS.85Pump Module, 8100 SeriesDirections for Use
INTRODUCTIONINTRODUCTIONAbout the Pump ModuleThe Medley Pump Module (8100 Series) is intended forfacilities that utilize infusion pumps for the delivery of fluids,medications, blood, and blood products using continuous orintermittent delivery through clinically acceptable routes ofadministration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces.The Medley Pump Module is indicated for use on adults,pediatrics, and neonates.Artifacts: It is normal for an infusion device to producenonhazardous currents when infusing electrolytes. Thesecurrents vary proportional to the infusion device flow rate.When an ECG monitoring system is not functioning underoptimal conditions, these currents may appear as artifacts,simulating actual ECG readings. To determine if ECGabnormalities are caused by patient condition or the ECGequipment, place the infusion device on hold. If the ECGreadings become normal, the ECG equipment requiresattention. Proper setup of the ECG equipment shouldeliminate these artifacts. Reference the appropriate ECGmonitoring system documentation for instructions on setupand maintenance.Compliance with Federal Aviation Regulations: TheMedley Pump Module has received a Statement ofCompliance with Federal Aviation Regulations for use as a“Portable Electronic Device Aboard Aircraft”. This is pursuantto the FAA Advisory Circular No. 91-21-1A and attested by anFAA Designated Engineering Representative with an FAA form8110-3, “Statement of compliance with the Federal AviationRegulations”.Contraindications: None known.This document provides directions for use for the Medley Pump Module.NOTE: The Medley Point-of-Care Unit was formerly known asthe Medley Programming Module.Pump Module, 8100 SeriesDirections for UseWARNINGRead all instructions, for both thePump Module and Point-of-CareUnit, before using the Medley System.INTRODUCTION1
Features and DefinitionsReference the “Alarms, Errors, Messages” chapter of the Medley Point-of-Care Unit Directions for Use(DFU) for the definitions of various alerts. Reference the Point-of-Care Unit DFU for system featuresand definitions.Auto-RestartPart of Medley System’s advanced Downstream OcclusionDetection system. If enabled, it minimizes nuisance patient-sideocclusion alarms caused by momentary kinking of tubing, IV pushes,etc.Bolus DoseAllows a bolus infusion to be programmed using either theGuardrails Drug Library or drug calculation feature. It can beprogrammed with or without a continuous infusion following a bolus.Channel LabelsAvailable when Profiles feature is enabled. It provides a hospitaldefined list of labels, displayed in Channel (Module) MessageDisplay, and identifies module with the solution being infused,catheter location, or other helpful information.Concentration LimitsLimits specified for the range of concentrations allowed for aparticular drug in a profile.Delay OptionsAllows system to be programmed to delay start of an infusion a) forup to 120 minutes or b) for a specific time up to 23 hours 59 minutes.A callback for a programmed delay can be scheduled to give an alertBefore an infusion is to be initiated, After an infusion is completed,Before and After an infusion, or no alert (None).Drug CalculationAllows: entry of drug dose (Medley System calculates correct flow rate toachieve desired dose),OR entry of flow rate (Medley System calculates corresponding drugdose).Dynamic Pressure DisplayAppears on Main Display. If enabled, it graphically displays currentpatient-side occlusion pressure set point and current patient-sideoperating pressure for that module. (Reference “Displays” section in“Getting Started” chapter for additional “Dynamic Pressure Display”information.)Free Flow ProtectionAll Medley System/Gemini administration sets utilize a uniqueclamping device, the Flo-Stop Device, to prevent inadvertent freeflow when the administration set is removed from the instrument.2 INTRODUCTIONPump Module, 8100 SeriesDirections for Use
Features and Definitions (Continued)A drug calculation mode available when the Profiles feature isenabled. It provides a hospital-defined list of drugs andconcentrations appropriate for use in as many as 10 profiles. DrugLibrary use automates programming steps, including drug name,drug amount and diluent volume, and activates hospital-establishedbest-practice Guardrails Limits.Guardrails LimitA programming limit or best-practice guideline determined byhospital/health system and entered into system’s data set. Supportsconcentration limits for all infusions that utilize concentration. Profilespecific limits are defined for flow rate, patient weight, and maximumand minimum continuous dose for each drug in a Guardrails DrugLibrary. Dose limits can be defined by hospital/health system aseither “hard” or “soft” limits.INTRODUCTIONGuardrails Drug Library A Guardrails Hard Limit is a programmed limit that cannot beoverridden, except in anesthesia mode. A Guardrails Soft Limit is a programmed limit that can beoverridden.KVO Rate AdjustUsed to select KVO (Keep Vein Open) rate (0.1 to 20 mL/h allowed),which is the rate of fluid flow after an “Infusion Complete” occurs.The KVO rate will never exceed the infusion rate.Multidose ModeAllows 2 - 24 doses to be programmed at equally spaced intervals onthe same Pump Module over a 24-hour period. This mode isdesigned to allow delivery of multiple, equal doses from the same IVcontainer at regularly scheduled intervals.Occlusion PressureA complete range of downstream occlusion detection options isprovided. Pump mode: Downstream occlusion alarm threshold is525 mmHg at flow rates of 30 mL/h or greater. For rates 30 mL/h, the occlusion pressure is rate-dependent, to ensurerapid response to occlusions. Selectable pressure mode: Downstream occlusion alarmthreshold can be adjusted in 25 mmHg increments, up tomaximum occlusion pressure of 525 mmHg. Auto-Restart: (See “Auto-Restart” definition.)In addition, the Medley System provides fluid-side occlusiondetection.Rapid BolusPump Module, 8100 SeriesDirections for UseFastest rate at which bolus dose should be delivered, as defined byfacility’s clinical best-practice guidelines.INTRODUCTION3
Features and Definitions (Continued)RestoreTo simplify programming, can be used to recall previous rate andvolume settings for the same patient. This option is only available ifthe patient is not new and the system is powered up within 8 hours oflast usage.Secondary InfusionsDual rate sequential piggyback (secondary) infusions may be infusedat delivery rates and volumes independent of primary infusionparameters. Automatic changeover occurs to the primary infusionparameters when the secondary infusion is complete if a Medley System/Gemini Check Valve Administration Set is used.Volume/DurationAllows a volume-to-be-infused (VTBI) and duration (infusion time) tobe programmed. The flow rate is automatically calculated.Symbols 75Canadian and U.S. Certification Mark: Products bearing this mark have been testedand certified in accordance with applicable U.S. and Canadian electrical safety andperformance standards (CSA C22.2 No. 601.1, UL 2601-1 and IEC 60601–2–24).Electrical Shock Protection Rating: Type CF, Defibrillation-proofIPX1!Protection against fluid ingress: Drip ProofAttention: Refer to accompanying documentation.IUI Connector: Inter-Unit Interface connector used to establish power andcommunications between Point-of-Care Unit and attached modules.MM-YYYYManufacturing Date: Number adjacent to symbol indicates month and year ofmanufacture.Consult operating instructions.OnlyCAUTION: Federal (U.S.A.) law restricts this device to sale by or on order of aphysician.Single-Use2XXµmSingle-Use. Do not re-use.Product contains micron filter, where XX represents filter size.4 INTRODUCTIONPump Module, 8100 SeriesDirections for Use
Symbols (Continued)DEHPINTRODUCTIONProduct contains a particular element; such as, DEHP in fluid pathway.Product DOES NOT contain a particular element; such as,latex-free.LATEX administration set isDrops per milliliter specification for product will be identified on drop symbol.XXProduct incorporates SmartSite Needle-Free Valve Ports and should not be accessedby a needle. XX mlApproximate administration set priming volume.Expiration date for product will be identified near hour glass symbol.Do not use if package is damaged.Pump Module, 8100 SeriesDirections for UseINTRODUCTION5
T H I S PA G EI N T E N T I O N A L LYLEFT BLANK6 INTRODUCTIONPump Module, 8100 SeriesDirections for Use
GETTING STARTEDWarnings and CautionsWarnings and Cautions provided throughout this Directions forUse (DFU) provide information needed to safely andeffectively use the Medley Pump Module and accessories.Medley System Warnings and Cautions, and definitions, arecovered in the Point-of-Care Unit DFU.OnlyGETTING STARTEDGeneralWARNINGS The Medley Pump Module is designed to stop fluid flowunder alarm conditions. Periodic patient monitoring mustbe performed to ensure the infusion is proceeding asexpected. It is a positive displacement delivery system,capable of developing positive fluid pressures to overcomewidely varying resistances to flow encountered in practice,including resistances to flow imposed by small gaugecatheters, filters and intra-arterial infusion. It is neitherdesigned nor intended to detect infiltrations and will notalarm under infiltration conditions. The use of positive displacement infusion devices portedtogether with gravity flow infusion systems into acommon IV site may impede the flow of common “gravityonly” systems, affecting their performance. Hospital/facilitypersonnel must ensure the performance of the common IVsite is satisfactory under these circumstances. To prevent a potential free-flow condition, ensure noextraneous object (for example, bedding, tubing, glove) isenclosed or caught in the Medley Pump Module door.Pump Module, 8100 SeriesDirections for UseGETTING STARTED7
Warnings and Cautions (Continued)Guardrails Safety SoftwareWARNINGS The Guardrails Safety Software incorporates dosinglimits and instrument configuration parameters based onhospital/facility protocol. The software adds a test ofreasonableness to drug programming based on the limitsdefined by the hospital/facility. Qualified personnel mustensure the appropriateness of drug dosing limits, drugcompatibility, and instrument performance, as part of theoverall infusion. Potential hazards include druginteractions, inaccurate delivery rates and pressure alarms,and nuisance alarms. When loading a data set with the Guardrails SafetySoftware, ensure the correct profile (for patient carearea) is selected prior to starting an infusion. Failure to usethe appropriate profile could cause serious consequences.Epidural AdministrationWARNINGS Epidural administration of drugs other than thoseindicated for epidural use could result in serious injury tothe patient. It is strongly recommended that the source container,Medley System/Gemini Administration Set, and PumpModule used for epidural drug delivery be clearlydifferentiated from those used for other types ofadministration. The Medley System can be used for epiduraladministration of anesthetic and analgesic drugs. Thisapplication is only appropriate when using anesthetics andanalgesics labeled for continuous epidural administrationand catheters intended specifically for epidural use. Useonly a Medley System/Gemini Series administration set,without a ‘Y’ connector or injection port, for epiduralinfusions. Epidural administration of anesthetic drugs: Useindwelling catheters specifically indicated for short-term(96 hours or less) anesthetic epidural drug delivery. Epidural administration of analgesic drugs: Useindwelling catheters specifically indicated for eithershort-term or long-term analgesic epidural drug delivery.8 GETTING STARTEDPump Module, 8100 SeriesDirections for Use
Warnings and Cautions (Continued)Administration SetsWARNINGSGETTING STARTED Use only Medley System/Gemini Series AdministrationSets. The use of any other set may cause improperinstrument operation, resulting in an inaccurate fluiddelivery or other potential hazard. For a list of compatiblesets, reference the Set Compatibility Card (providedseparately). Discard if packaging is not intact or protector caps areunattached.CAUTIONBefore operating instrument, verify that administration set isfree from kinks and installed correctly in instrument.Pump Module, 8100 SeriesDirections for UseGETTING STARTED9
Operating Features, Controls and IndicatorsFront/Side View - Door ClosedIUI Connector, RightStatus IndicatorsIUI Connector, Left(not te DisplayRMALASTANDBYINFUSEChannel (Module) Message DisplayChannel (Module) IdentificationChannel (Module) Select Key: Whenpressed, selects corresponding module forinfusion parameter entry and infusionsetup.NELC
Bolus Dose Allows a bolus infusion to be programmed using either the Guardrails Drug Library or drug calculation feature. It can be programmed with or without a continuous infusion following a bolus. Channel Labels Available when Profiles feature is enabled. It provides a hospital-
