Directions for Use - Med One Group › pdf › manuals › userManuals › Alari… · PCA Dose The PCA Dose enables a patient to self-administer a bolus infusion to be delivered

Directions for UsePatient Controlled Analgesia (PCA) Module, 8120 Series

ALARIS Medical Systems, Inc.Medley™ Medication Safety System

PCA

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EL8120

T H I S PA G EI N T E N T I O N A L LY

L E F T B L A N K

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GETTIN

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ALA

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TABLE OF CONTENTS

INTRODUCTIONABOUT THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

GETTING STARTEDWARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Unpacking PCA Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15ATTACHING AND DETACHING MODULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16PREPARING SYRINGE AND ADMINISTRATION SET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16ATTACHING AND DETACHING DOSE REQUEST CORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Choosing YES or NO to New Patient? and Profile? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Selecting Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

PREPARING INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Loading Syringe and Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Security Lock Key Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Selecting Syringe Type and Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Programming an Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

PCA INFUSION MODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29PCA Module Programming Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Setting Up PCA Dose Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Setting Up Continuous Infusion Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Setting Up PCA Dose + Continuous Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Setting Loading Dose Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Setting Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Stopping a Loading, PCA or Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Changing Programming Parameters During an Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Viewing Patient History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Clearing Patient History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Viewing Drug Event History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Configuring Dose Request Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Security Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Restoring Infusion Following Syringe Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Stopping Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Selecting Pressure Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Viewing and Clearing Volume Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Changing Syringe During Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Powering Off Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

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TABLE OF CONTENTS i

ALARMS, ERRORS, MESSAGESDEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Syringe Adjustment Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

MAINTENANCESPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65PCA Module Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

COMPATIBLE SYRINGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67COMPATIBLE SETS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

APPENDIXTRUMPET AND START-UP CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

ii TABLE OF CONTENTS

GENERAL CONTACT INFORMATION

Customer Care - North AmericaInstrument return, service assistance, and order placement.

United States:Phone:

(800) 482-4822

Canada:Phone:

(800) 387-8309

Customer Advocacy - North AmericaClinical and technical feedback.

Phone: (800) 854-7128, Ext. 7812E-Mail: [email protected]

Technical Support - North AmericaMaintenance and service information support; troubleshooting.

United States:Phone:

(858) 458-6003(800) 854-7128, Ext. 6003

Canada:Phone:

Eastern: (800) 908-9918Western: (800) 908-9919


L E F T B L A N K

The Medley™ Medication Safety System is a modular infusionand monitoring system intended for use in today’s growingprofessional healthcare environment, for use in adult, pediatricand neonatal care. The Medley™ Medication Safety Systemconsists of the Point-of-Care Unit (PCU) (8000 Series), theGuardrails® Safety Software, and up to four detachablemodules which provide infusion or monitoring capabilities.

The Medley™ PCU controls the Medley™ System and providesa common user interface for programming and monitoring aninfusion, which helps to reduce complexity at the point of care.

The Medley™ Patient Controlled Analgesia (PCA) Module(Model 8120) is intended for facilities that utilize syringepumps for the delivery of medications or fluids usingcontinuous or intermittent delivery through clinicallyacceptable routes of administration; such as, intravenous (IV),subcutaneous or epidural.

The Guardrails® Safety Software for the Medley™ Systembrings a new level of medication error prevention to the pointof patient care. The Guardrails® Safety Software featureshospital-defined medication dosing guidelines for up to tenpatient-specific care areas, referred to as profiles. Eachprofile contains a specific drug library and channel labels, aswell as instrument configurations appropriate for the carearea. Optional drug-specific Guardrails® Clinical Advisoriesprovide visual messages. Dosing limits for each drug entrymay be either Guardrails® Hard Limits that cannot beoverridden during infusion programming, or Guardrails® SoftLimits that can be overridden, based on clinical requirements.

A data set is developed and approved through the facility’sown multi-disciplinary team using the Guardrails® Editor, thePC–based authoring tool. A data set is then transferred to theMedley™ System by qualified personnel. The approved datasets are maintained by the Guardrails® Editor for futureupdates and reference. A data set is required prior to usingthe Medley™ PCA Module.

Information about Guardrails® Alerts that occur during use arestored within the Medley™ PCU, and can be accessed usingthe Guardrails® Continuous Quality Improvement (CQI) EventTracker and Guardrails® CQI Reporter.

INTR

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INTRODUCTION

INTRODUCTION 1

About the System

2 INTRODUCTION

This document provides directions for use for the Medley™

PCA Module. Read all instructions, for both the Medley™ PCAModule and the Medley™ PCU before using the Medley™

System.

The Medley™ PCA Module uses non-dedicated standard orpre-filled, single-use, disposable syringes (with luer-lockconnectors) and administration sets with anti-siphon valves,designed for use on syringe-type PCA devices. For specificadministration set instructions, refer to the directions for useprovided with the set. For set priming and loadinginstructions, refer to the “Preparing Infusion” section in the“Getting Started” chapter of this document.

Contraindications: None known.

About the System (Continued)

Refer to the “Alarms, Errors, Messages” chapter of this Directions for Use for the definitions of variousalerts. Refer to the Medley™ PCU Directions For Use for system features and definitions.

Auto Pressure Limit Adjustment When a bolus is delivered, the pressure alarm limits aretemporarily raised to the maximum limit.

Auto Syringe Identification The system automatically detects the syringe size andnarrows down the syringe selection list.

Bolus Dose The Bolus Dose feature enables a clinician to program anadditional amount of medication once the PCA infusion hasbegun. The current PCA infusion will resume following thedelivery of a bolus dose.

Dose Request Cord When attached, the dose request cord allows a patient to self-administer a PCA dose to be delivered according toprogrammed PCA parameters. The dose request cordfeatures an indicator light which can be configured to providefeedback to the patient on requested PCA doses. The doserequest cord is enabled in PCA only and PCA + Continuousmodes.

Drug Event History Records and displays sequential device events for a typical 12hours, subject to change upon usage and number of modules.

Event Logging Event Logging records instrument operations.

Guardrails® Clinical Advisory A Guardrails® Clinical Advisory is a visual message thatappears when a designated drug is selected, to remind aclinician of specific hospital standards of practice whenprogramming an IV medication. A specific clinical advisorycan be associated with a selected drug within any of thepatient care profiles.

Guardrails® Drug Library The Guardrails® Drug Library feature is a drug calculationmode available when the Profiles feature is enabled. Itprovides a hospital-defined list of drugs and concentrationsappropriate for use in as many as 10 profiles. Using the DrugLibrary automates programming steps, including the drugname, drug amount and diluent volume, and activates thehospital-established best-practice Guardrails® Limits. AGuardrails® Safety Software data set is required prior to usingthe Medley™ PCA Module.

INTRODUCTION 3

INTR

OD

UC

TION

Features and Definitions

4 INTRODUCTION

Features and Definitions (Continued)

Guardrails® Limit A Guardrails® Limit is a programming limit or best-practiceguideline for programming a dose limit parameter orinstrument configuration determined by the hospital/healthsystem and entered into the system’s data set. Dose limitscan be defined by the hospital/health system as either “hard”or “soft” limits.

• A Guardrails® Hard Limit is a programmed limit that cannotbe overridden.

• A Guardrails® Soft Limit is a programmed limit that can beoverridden.

Loading Dose The Loading Dose enables a clinician to program a bolusinfusion prior to initiation of the PCA infusion. The LoadingDose may be programmed from the Infusion Modes menu orapplicable PCA, PCA + Continuous or Continuous Onlyprogramming screen prior to the start of a new PCA infusionprogram.

Lockout Interval Allows the clinician to program a pre-determined interval oftime that must elapse between delivery of PCA doses.

Occlusion Pressure Downstream occlusion alarm threshold can be set to low,medium, or high.

Operating Modes The PCA Module has four operating modes available:

• PCA only

• Continuous Infusion

• PCA + Continuous Infusion

• Loading Dose Only

All programming of infusions in each of the four modes arecompleted using the Guardrails® Drug Library.

Near End of Infusion (NEOI) The NEOI option allows an alert to be configured to soundanywhere between 5 - 25% volume remaining.

INTRODUCTION 5

Features and Definitions (Continued)

INTR

OD

UC

TION

Patient History The PCA Module records and displays patient history for up to24 hours, and may be trended to the following intervals:1hr/2hr/4hr/8hr/12hr/24hr. Patient history includes thefollowing trending information:

• Total demands

• Delivered demands

• Total drug delivered

• Time and date patient history last cleared

• Average drug per hour

• Total amount of drug delivered via:

PCA Dose

Continuous Infusion

Loading Dose

Bolus Dose

PCA Dose The PCA Dose enables a patient to self-administer a bolusinfusion to be delivered at programmed lockout intervalsthrough the dose request cord. When programmed in thePCA+Continuous mode, the continuous infusion will resumefollowing the PCA dose.

Priming The Priming option allows a limited volume of fluid to bedelivered in order to prime the administration set prior to beingconnected to a patient or after changing a syringe. Whenpriming, a single continuous press of the PRIME soft keydelivers up to 2 mL of priming/fluid.

Restore To simplify programming, the Restore feature can be used torecall previous PCA programming parameters for the samepatient. This option is only available if the patient is not newand the system is powered up within 8 hours of last usage.

Syringe Empty The instrument gives an alert and stops when an emptysyringe is detected.

Syringe Volume Detection The system automatically detects the fluid volume in a syringewhen it is inserted.

6 INTRODUCTION

Symbols

Canadian 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 60601-1 and IEC 60601–2–24).

Electrical Shock Protection Rating: Type CF, Defibrillation-proof (PCA Module)

Electrical Shock Protection Rating: Type BF, Defibrillation-proof (Dose Request Cord)

Protection against fluid ingress: Drip Proof

Attention: Refer to accompanying documentation.

IUI Connector: Inter-Unit Interface connector used to establish power andcommunications between the Point-of-Care Unit and attached channels.

Manufacturing Date: Number adjacent to symbol indicates the month and year ofmanufacture.

Consult operating instructions.

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of aphysician.

Single-Use. Do not re-use.

Product contains a particular element; such as, = DEHP in fluid pathway.

Product DOES NOT contain a particular element; such as, = administration set islatex-free.

Approximate administration set priming volume.

Expiration date for product will be identified near hour glass symbol.

Do not use if package is damaged.

Administration set with filter may be used.

DEHP

� ��

IPX1

!

MM-YYYY

nlyO

� XX ml

2Single-Use

xxµm

NOTE: Although the Medley™ Medication Safety System is builtand tested to exacting specifications, it is not intended to replacethe supervision of IV infusions by medical personnel. The usershould become thoroughly familiar with the features andoperation of the Medley™ System and exercise vigilance in itsutilization.

GETTING STARTED

GETTING STARTED 7

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Warnings and Cautions

nlyO

When properly secured/snapped, the bottom latch provides avery secure connection between modules. If not properlylatched, a module can be dislodged during operation.

WARNING

Do not use the Medley™ System in close proximity of MagneticResonance Imaging (MRI).

WARNING

A is an alert describing the potential forserious consequences to the patient or user; such as, death,injury or adverse reactions.

A is an alert to take special care for the safeand effective use of the device.

For WARNINGS and CAUTIONS for the The Medley™ Point-of-Care Unit, refer to the The Medley™ Point-of-Care UnitDirections for Use.

CAUTION

WARNING

This instrument is designed to stop fluid flow under alarmconditions. Periodic patient monitoring must be performed toensure the infusion is proceeding as expected.

WARNING

The Guardrails® Safety Software incorporates dosing limitsand instrument configuration parameters based on hospitalprotocol. The software adds a test of reasonableness to drugprogramming based on the limits defined by the hospital.Qualified personnel must ensure the appropriateness of thedrug dosing limits, the compatibility of the drugs, and theperformance of each instrument, as part of the overallinfusion. Potential hazards include drug interactions, andinappropriate delivery rates and pressure alarms.

WARNING

8 GETTING STARTED

Warnings and Cautions (Continued)

The Medley™ PCA Module is a positive displacement deliverysystem, capable of developing positive fluid pressures toovercome widely varying resistances to flow encountered inpractice, including resistances to flow imposed by small gaugecatheters and filters. It is neither designed nor intended todetect infiltrations and will not alarm under infiltrationconditions.

WARNING

When loading a data set with the Guardrails® Safety Software,ensure the correct profile (for patient care area) is selectedprior to starting an infusion. Failure to use the appropriateprofile could cause serious consequences.

WARNING

Hospital personnel must ensure the compatibility of the drugsas well as the performance of each channel as part of theoverall infusion. Potential hazards include drug interactions,inaccurate delivery rates, inaccurate pressure alarms andnuisance alarms.

WARNING

Use only standard or pre-filled, single-use, disposablesyringes (with luer-lock connectors) and non-dedicatedadministration sets with anti-siphon valves, designed for useon syringe-type PCA devices. The use of any other syringe oradministration set may cause improper instrument operation,resulting in inaccurate fluid delivery, or other potentialhazards. For a list of compatible syringes, refer to the“Compatible Syringes” section in the “Maintenance” chapter.For a list of compatible administration sets, refer to the SetCompatibility Card (provided separately and in this Directionsfor Use).

WARNING

Before loading or unloading the syringe, always turn off fluidflow to the patient, using the tubing clamp or stopcock.Uncontrolled fluid flow can occur when the administration setis not clamped or turned off, and may cause serious injury ordeath.

WARNING

When an occlusion occurs, there is a risk of infusingpressurized buildup of infusates upon correction of theocclusion. To avoid an inadvertent bolus, relieve the pressurebefore restarting the infusion.

WARNING

GETTING STARTED 9


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When priming:

• Ensure patient is not connected.• Ensure air is expelled from line prior to beginning infusion

(unexpelled air in line could have serious consequences).Failure to prime correctly can delay infusion delivery andcause the total volume to be infused to read higher than theactual total delivered to the patient.

WARNING

Ensure the syringe manufacturer and syringe size displayedmatches the syringe manufacturer and syringe size installed inthe Medley™ PCA Module. Mismatches may cause an under-infusion or over-infusion to the patient that could result inserious injury and/or death. For a list of compatible syringes,refer to the “Compatible Syringes” section in the“Maintenance” chapter.

WARNING

References in this document to specific drugs and drug dosesare for illustration purposes only. Refer to specific drugproduct labeling for information concerning appropriateadministration techniques and dosages.

WARNING

The use of positive displacement infusion devices portedtogether with gravity flow infusion systems into a common IVsite may impede the flow of common “gravity only” systems,affecting their performance. Hospital personnel must ensurethe performance of the common IV site is satisfactory underthese circumstances.

WARNING

Each time the Medley™ System is turned on, verify and/or setthe pressure alarm limit. If the pressure alarm limit is notverified, the instrument may not operate within the desiredocclusion detection parameter(s).

WARNING

10 GETTING STARTED


Parallel Infusions

There are no contraindications regarding the use of theMedley™ System with any other positive displacementinfusion device when ported together into a common IV sitelocation.

When the Medley™ PCA Module is used with a primary IVline, use of an appropriate Y-set with a backcheck valve ishighly recommended. Failure to properly use a Y-set mayresult in retrograde analgesic flow into the primary line duringa partial or complete downstream occlusion. This maysubsequently result in an inadvertent bolus to the patientwhen the occlusion is cleared.

WARNING

User Precautions

To ensure proper performance of the Medley™ System and toreduce potential injury, observe the following precautions:

• Potent analgesic medications are used with this device.Refer to drug package insert for precautions and possibleadverse reactions.

• Refer to analgesic package enclosure for possibleincompatibility with fluid or drug being delivered through themaintenance line.

• It is recommended that highly viscous solutions and drugs,colloidal suspensions and emulsions should not bedelivered through the inline backcheck valve on themaintenance side of the PCA set. Valve functionality maybe compromised by the presence of residue.

• Disconnect from main (AC) power when performingmaintenance.

• Do not open the instrument case. The case should only beopened by qualified service personnel using propergrounding techniques.

GETTING STARTED 11


User Precautions (Continued)Epidural Administration

The Medley™ PCA Module can be used for epiduraladministration of anesthetic and analgesic drugs. Thisapplication is only appropriate when using analgesics andanesthetics labeled for continuous epidural administration andcatheters intended specifically for epidural use. Use onlystandard, single-use, disposable syringes (with luer-lockconnectors) and administration sets, designed for use onsyringe pumps and without a ‘Y’ connector or injection port,for epidural infusions.

• Epidural administration of anesthetic drugs: Use indwellingcatheters specifically indicated for short-term anestheticepidural drug delivery.

• Epidural administration of analgesic drugs: Use indwellingcatheters specifically indicated for either short-term orlong-term analgesic epidural drug delivery.

Epidural administration of drugs otherthan those indicated for epidural usecould result in serious injury to thepatient.

WARNING

It is strongly recommended that thesyringe, administration set, and theMedley™ PCA Module used forepidural drug delivery be clearlydifferentiated from those used forother types of administration.

WARNING

Administration Sets and Syringes

• For a list of compatible syringes, refer to “CompatibleSyringes” section in “Maintenance” chapter.

• For a list of compatible administration sets, refer to SetCompatibility Card (provided separately and in thisDirections for Use).

• For specific administration set instructions, refer toDirections For Use provided with set. For set priming andloading instructions, refer to “Preparing Infusion” section ofthis document.

• Before operating instrument, verify that administration setis free from kinks and installed correctly in instrument.

• The administration sets compatible with the Medley™ PCAModule are supplied with a sterile fluid path for one-timeuse. Do not resterilize.

• Fluid path is STERILE and NONPYROGENIC.• Discard if packaging is not intact or protector caps are

unattached.• For administration set replacement interval, refer to facility

protocol and/or government standards (such as, CDCguidelines in the United States).

• For IV push medication, put instrument on hold, clamptubing above the port.

• Flush port(s) per facility protocol.• Discard administration set per facility protocol.

Use only standard or pre-filled, single-use, disposable syringes (with luer-lock connectors) and non-dedicatedadministration sets with anti-siphonvalves, designed for use on syringe-type PCA devices. The use ofincompatible syringe or administrationset may cause improper instrumentoperation, resulting in inaccurate fluiddelivery, or other potential hazards.For a list of compatible syringes, referto the “Compatible Syringes” sectionin the “Maintenance” chapter. For alist of compatible administration sets,refer to the Set Compatibility Card(provided separately and in thisDirections for Use).

WARNING

Dose Request Cord Use

• Only the patient should press the dose request cordbutton.

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12 GETTING STARTED


User Precautions (Continued)

ArtifactsIt is normal for an infusion device to produce nonhazardouscurrents when infusing electrolytes. These currents varyproportional to the infusion device flow rate. When the ECGmonitoring system is not functioning under optimal conditions,these currents may appear as artifacts, simulating actual ECGreadings. To determine if ECG abnormalities are caused bypatient condition or the ECG equipment, place the infusiondevice on hold. If the ECG readings become normal, theECG equipment requires attention. Proper setup of the ECGequipment should eliminate these artifacts. Reference theappropriate ECG monitoring system documentation forinstructions on setup and maintenance.

Radio Frequency Interference

Operating the system near equipment which radiates high-energy radio frequencies (electrosurgical/cauterizingequipment, portable radios, cellular telephones, etc.) maycause false alarm conditions. If this happens, reposition theinfusion device away from the source of interference or turnoff the infusion device and manually regulate the flow with theclamp and/or monitor the vital parameters using anappropriate clinical alternative.

Electromagnetic Compatibility (EMC)

When using the Medley™ PCA Module in combination witha Medley™ Point-of-Care Unit which is interconnected tohospital data communications equipment and/or nurse callsystems (signal input and signal output ports), the externalsystems must be certified to applicable standards to ensurecorrect operation and electromagnetic compliance integrity

Interconnected data communications systems must becertified to IEC 60950 (data processing equipment) orIEC 60601–1 electromedical equipment. Nurse call systemsmust be certified to UL 1069 (hospital signaling and nursecall equipment) or comply with the requirements specifiedin IEC 60601–1.

Compliance with the electromagnetic compatibility standard(IEC 60601-1-2) is a function of all interconnectedequipment including cabling and, as such, it is theresponsibility of the hospital/facility to ensure externalequipment complies with the applicable EMC standards.Failure to verify that external equipment meets applicableEMC standards may result in degraded electromagneticcompatibility (refer to “Radio Frequency Interference”warning for additional information)

Use of accessories or cables otherthan those specified may result indegraded electromagneticcompatibility performance of thisdevice.

WARNING

GETTING STARTED 13


User Precautions (Continued)

Dropping/JarringShould an instrument be dropped or severely jarred, itshould be immediately taken out of use and inspected byqualified service personnel, to ensure its proper functionprior to reuse.

Operating EnvironmentNot for use in the presence of flammable anesthetics.

Explosion risk if used in thepresence of flammable anesthetics.

DANGER

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14 GETTING STARTED

Controls and Indicators

Rate Display

Channel Message Display

Channel Identification

Channel Release Lever

Channel Select Key - Whenpressed, selects correspondingchannel for infusion parameterentry and infusion setup.

Pause Key - When pressed during aninfusion, temporarily stops infusion onthat channel. After approximately2 minutes, a visual and audio promptbegins.

Channel Off Key - When pressed andheld for one second and then released,stops infusion on that channel, deselectsthat channel, and if only that channelhad been operating, system powersdown. Repeat for other operatingchannels to power off each channel.

Restart Key - When pressed, resumesoperation of a previously paused oralarmed infusion on that channel.

Infusing(green)

Alarm(red)

Standby(yellow)

Status Indicators

IUI Connector, Left

Gripper Control /Drive HeadRelease (shownin closed position)

PlungerGrippers (shownin closed position)

Syringe BarrelClamp / Sizer

Syringe BarrelSensor

Dose Request CordAttachment

Security Lock

Security Door

Dose Request Cord

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Installation

1. Remove the Medley™ PCA Module from its carton.

2. Verify gripper control/drive head release, plungergrippers, and syringe barrel clamp/sizer operate freelyand correctly.

3. Verify control surface and instrument housing is notdamaged.

4. Check for loose parts.

5. Perform Periodic Inspections (see “InspectionRequirements” section in “Maintenance” chapter).

6. Perform check-in procedure (provided separately; contactALARIS Medical Systems for further information). If theMedley™ PCA Module fails initial test, it must be removedfrom service and inspected by qualified personnel.

If the Medley™ PCA Module is damaged, contact ALARISMedical Systems for authorization to return the instrument forrepair.

Instruments are tested and calibrated before they arepackaged for shipment. To ensure proper operation aftershipment, it is recommended that an incoming inspection beperformed before placing the instrument into use.

Unpacking PCA Module

Attaching and Detaching Channels

Refer to the Medley™ Point-of-Care Unit Directions for Use.

Displays

The displays illustrated throughout this document are forillustration purposes only. The display content will vary,depending on configuration settings, type of disposable in use,hospital-defined data set uploaded using the Guardrails®

Safety Software, programmed drug calculation parameters,and many other variables.

16 GETTING STARTED

Main Display

Preparing Syringe and Administration Set

Title Bar

Channel Status

• An outlined Channel Letterdisplay indicates channel isattached and ready for use.

• A solid Channel Letter displayindicates channel is operating.

Soft Keys

A

AUDIOADJUST

Midtown HospitalMed Surg

B VTBI = ALL (30 mL)

VOLUMEINFUSED

SYSTEM

ON

Refer to the Medley™ Point-of-Care Unit Directions for Usefor general information on the Main Display.

A

_ _30 mcg

_ _ _ _ mL

Hour

mcg

>Select DILUENT VOLUME

[Conc]:

FentanylGuardrails Drug Library

DRUGAMOUNT

DILUENTVOLUME

TIMEUNITS

DOSINGUNITS

DRUGLIBRARY

SYSTEM

ON

Channel Selected Indicator

“Active” Soft KeyHighlighted indicates a selectedsoft key.

“Inactive” Soft KeyNonhighlighted indicates anonselected soft key.

Prompt BarLook here for user prompts.

1. Prepare syringe (reference “Compatible Syringes” sectionin “Maintenance” chapter) in accordance withmanufacturer’s directions for use.

2. Prepare administration set (reference Set CompatibilityCard, provided separately and in this Directions for Use)in accordance with manufacturer’s directions for use.

3. Attach upper fitting of administration set to syringe tip.

Use only standard or pre-filled, single-use, disposable syringes (with luer-lock connectors) and non-dedicatedadministration sets with anti-siphonvalves, designed for use on syringe-type PCA devices. The use ofincompatible syringe or administrationset may cause improper instrumentoperation, resulting in inaccurate fluiddelivery, or other potential hazards.For a list of compatible syringes, referto the “Compatible Syringes” sectionin the “Maintenance” chapter. For alist of compatible administration sets,refer to the Set Compatibility Card(provided separately and in thisDirections for Use).

WARNINGNOTE: Use Aseptic Technique.

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Attaching and Detaching Dose Request Cord

The Dose Request Cord must be attached to the PCA Modulewhen delivering a PCA Dose or PCA + Continuous Doseinfusion.

To attach the Dose Request Cord:

• Insert latching connector into Dose Request Cordattachment. The red marking on the latching connectorshould be aligned with the red marking on the DoseRequest Cord attachment.

To detach the Dose Request Cord:

• Hold the body of latching connector and pull straightaway, without twisting or turning, from the Dose RequestCord attachment.

Red alignmentmarks

Latching Connector

Dose RequestCord Attachment

Entering Patient ID


Start-Up

Responding to Maintenance Reminder


Powering On System

Choosing Yes or No to New Patient? and Profile?


Selecting Profile



18 GETTING STARTED

GETTING STARTED 19

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Preparing Infusion

Loading Syringe and Administration Set

• Before loading the syringe, checkit for damage or defects.

• Ensure syringe barrel, flange,and plunger are installed andsecured correctly. Failure toinstall syringe correctly can resultin uncontrolled fluid flow to thepatient, and may cause seriousinjury or death.

• Before loading or unloading thesyringe, always turn off fluid flowto the patient, using the tubingclamp or stopcock. Uncontrolledfluid flow can occur when theadministration set is not clampedor turned off, and may causeserious injury or death.

WARNINGS

When initially loading the syringe,allow for the volume of fluidcontained in the administration setand retained in the syringe at theend of an infusion, as this “deadspace” will not be infused.

CAUTION

1. 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.

ALARM INFUSE STANDBY

CHANNELSELECT

RATE (mL/h)

Syringe Barrel Clamp Open

20 GETTING STARTED

Preparing Infusion (Continued)

Loading Syringe and Administration Set (Continued)

2. Raise drive head to its fully extended position.

a. Twist gripper control clockwise and hold in position.

NOTE: The gripper control is spring loaded. Whentwisted to the open position and then released, it (andthe plunger grippers) will return to the closed position.

b. While holding gripper control in open position, raisedrive head to full extension.

c. Gently release gripper control.

3. Insert syringe (from front of instrument) by sliding flatedge of syringe barrel flange between barrel flangegripper

NOTE: Ensure syringe is loaded to allow syringelabeling and gradation marks to face forward for easierviewing.

4. Lock syringe in place.

a. Pull syringe barrel clamp out and hold.

b. Rotate clamp to right (clockwise or counter clockwise)until it lines up with syringe.

c. Gently release clamp against syringe.

5

10

15

20

25

30

35

40

45

50

55

½

1oz

1½

2oz60

Drive Head Fully Extended

Plunger GrippersOpen

50

552oz60

Gripper Control / DriveHead Release in OpenPosition


CHANNELSELECT

PAUSE

RATE (mL/h)

20

25

301oz

oz60

35

40

45

50

1½

552

GETTING STARTED 21

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Loading Syringe and Administration Set (Continued)

5. Lower drive head and lock plunger in place with plungergrippers.

a. Twist gripper control clockwise and hold in position.

NOTE: The gripper control is spring loaded. Whentwisted to the open position and then released, it (andthe plunger grippers) will return to the closed position.

b. While holding gripper control in open position, gentlylower drive head until it makes contact with plungerflange.

c. Gently release gripper control.

d. Ensure plunger grippers lock and hold plunger inplace.


RATE (mL/h)

oz60

40

45

50

1½

552

Plunger GrippersClosed

Gripper Control inClosed Position

Drive Head Flushwith Plunger Flange

There are three key positions associated with the securitylock:

• UNLOCK unlocks the security door. The key must be in thisposition when loading or changing a syringe.

• PROGRAM allows for changes in programming the devicewithout unlocking the security door or interrupting the currentinfusion.

• LOCK locks the security door. They key must be in thisposition to start an infusion.

Security Lock Key Positions

At the start of an infusion program, the system prompts userto select and confirm the syringe type and size.

NOTE: The system automatically detects the syringe size, andlists syringe types and sizes that most closely match the installedsyringe. If the syringe is not recognized, “Syringe notrecognized” displays.

1. Press CHANNEL SELECT key. Key must be in PROGRAMposition.

Ensure the displayed syringemanufacturer and size correctlyidentifies the installed syringe.Mismatches may cause an under-infusion or over-infusion to thepatient that could result in seriousinjury and/or death. For a list ofcompatible syringes, refer to the“Compatible Syringes” section in the“Maintenance” chapter. If theinstalled syringe is displayed andselected, but is not recognized,servicing is required (refer to“Service Information” section in“Maintenance” chapter).

WARNING

Selecting Syringe Type and Size

>Select Channel

A

AUDIOADJUST



22 GETTING STARTED

GETTING STARTED 23


Selecting Syringe Type and Size (Continued)

IMS Pre-fill 30 mL

>Select Syringe Size

AA Syringe Selection

CONFIRM

>Confirm Syringe Size

AA Syringe Selection

CONFIRM

IMS Pre-fill 30 mL

2. Press soft key next to installed syringe type and size.

• Selection is highlighted.

3. To accept, press CONFIRM soft key.

• Guardrails® Drug Library screen displays.

The Priming option can be enabled at the time the Medley™System is configured for use. The Priming selection (PRIMEsoft key) is available only after the syringe type andmedication selection (prior to infusion mode selection).

When priming:

• Ensure patient is not connected.• Ensure air is expelled from line

prior to beginning infusion(unexpelled air in line could haveserious consequences).

Failure to prime correctly can delayinfusion delivery and cause the totalvolume to be infused to read higherthan the actual total delivered to thepatient.

WARNING

During priming, the pressure limitalarms are temporarily increased totheir maximum level.

CAUTION

Priming

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24 GETTING STARTED


Priming (Continued)

1. Press OPTIONS key.

2. Press Prime Set with Syringe soft key.

3. Set key to PROGRAM position.

4. Press and hold PRIME soft key until fluid flows andpriming of syringe administration set is complete.

NOTE: Fluid is delivered during priming only while thePRIME soft key is pressed. Each press of the PRIME softkey delivers up to 2 mL of priming/fluid per continuouspress. To deliver additional amounts, press the PRIME softkey again.

• Volume used during priming is displayed but not addedto VTBI.

A

>Select an Option orEXIT

EXIT

Pressure Limit - High

Channel Options 2 of 2

Prime Set with Syringe

PAGEUP

AAACONTINUOUS INFUSION

Drug CalculationHeparinA

Set the key to ‘Program’position.

>Set Key to PROGRAM

Position

PCA

EXIT

A


>Press and Hold PRIME

Prime Volume

0 mL

CAUTION: Donot prime withdisposable setconnected topatient!

PRIME EXIT

GETTING STARTED 25


2.1 mL

A


>Press and Hold PRIME

Prime Volume

CAUTION: Donot prime withdisposable setconnected topatient!

EXITPRIME

5. When priming is complete, release PRIME soft key.

6. To return to main screen, press EXIT soft key.

• Guardrails® Drug Library screen displays.

7. Select Infusion Mode.AAAA

PCA Dose only

Loading Dose Only

A

Continuous Infusion

>Select an Option or

CANCEL

MorphineGuardrails Drug Library

PCA Dose + Continuous

INFUSION MODE

SETUP DRUGLIBRARY

Programming An Infusion

The following procedures should be used when programmingan infusion.

1. Perform steps in “Preparing Syringe and AdministrationSet” section.

2. Perform steps in “Start-Up” section, to:

a. Power on system.

b. Choose Yes or No to New Patient?.

Midtown Hospital

Yes

No

NEW PATIENT ?

>Select Yes or No

“Yes” Clears PreviousPatient Data

DISPLAYCONTRST

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Priming (Continued)

26 GETTING STARTED

c. Select profile, if required.

d. Enter patient identifier, if required.

3. Press CHANNEL SELECT key.

4. Unlock security door or set key to PROGRAM position.

5. Confirm time of day or change time if necessary.


Programming An Infusion (Continued)


Yes

No

>Select Yes or No

Med Surg ?

“Yes” Confirms SameProfile

>Select Channel

A

AUDIOADJUST


VOLUMEINFUSED

A

Set key to ‘Program’position.

>Set key to PROGRAM

Position

PCA

EXIT

A

Time of Day

ChangeTime

Current time:08:00

>CONFIRM Time-of-Day

CONFIRM

PCA

EXIT

6. Perform steps in “Preparing Infusion” section, to:

a. Load syringe and administration set.

b. Select and confirm syringe type and size.

c. Prime syringe using Prime feature, if desired.

7. Press soft key next to desired drug and concentration.

• Drug/Concentration screen access confirmationappears.

NOTES:• To view additional drugs/concentrations, press PAGE UP

and PAGE DOWN soft keys.• The facility may choose to prepopulate standard drug

concentrations, or leave an open entry (_ _ / _ _ mL) andallow the clinician to enter the drug amount and diluentvolume.



EXIT

A

>Select Drug/Concentration

A

Morphine 1 mg/mL

Morphine 5 mg/mL

Meperidine 10 mg/mL

Guardrails Drug LibraryMed Surg

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GETTING STARTED 27

28 GETTING STARTED



8. Confirm the drug and concentration selection and pressYes soft key. To change selection, press No soft key.

• If Yes was selected and facility has defined a ClinicalAdvisory for that drug, a message appears. Tocontinue programming, press CONFIRM soft key.

• If Yes was selected to continue programming, drugamount and diluent volume (as defined in Guardrails®

Drug Library) are automatically entered for selecteddrug.

• If selected drug had “_ _ / _ _ mL” concentration, drugamount and diluent volume will need to be entered.

NOTES:• If the programmed “_ _ / _ _ mL” concentration is outside

the Guardrails® Soft Limit, a prompt appears beforeprogramming can continue. If the YES soft key ispressed, programming continues; if the NO soft key ispressed, the infusion must be reprogrammed.

• If the programmed “_ _ / _ _ mL” concentration is outsidethe Guardrails® Hard Limit for that care area, a promptappears before programming can continue. The drugamount and diluent volume must be reprogrammed.

9. Verify parameters are correct and press NEXT soft key toconfirm.

A

>Press Yes or No

Morphine1 mg/mL wasselected.Is this correct?

Yes

No


ADRUG

AMOUNT

DILUENTVOLUME

30 mg

30 mL

Hour

mg

>Press NEXT to Confirm

NEXT

TIMEUNITS

DOSINGUNITS

[Conc]: 1 mg/mL

Guardrails Drug LibraryMorphine

DRUGLIBRARY

GETTING STARTED 29

PCA Infusion Modes

PCA Module Programming Parameters

The Medley™ PCA Module uses the following programmingparameters,depending on infusion mode selected. Refer tothe Features and Definitions of this Directions for Use for thedefinitions and features of the infusion modes.

•PCA Dose: patient self-administered dose.•Lockout Interval: programmed time elapse betweenavailability of PCA doses.•Continuous Dose: basal rate dose.•Max Limit: (optional) total amount of drug which can beinfused over a specified time period.•Loading Dose: (optional) bolus dose infused prior toinitiation of PCA infusion.•Bolus Dose: (optional) additional dose programmed afterthe initiation of PCA infusion.

NOTE: When the Medley™ Point-of-Care Unit is in theInfusion Mode Selection, Infusion Setup or Bolus Setupscreens, a patient dose request from the dose request cordwill be handled as an unmet demand.

GETTIN

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Setting Up PCA Dose Only

AAAA

PCA Dose only

Loading Dose Only

A

Continuous Infusion


CANCEL



INFUSION MODE

SETUP DRUGLIBRARY

The following procedures should be used when programminga PCA Dose Only infusion.

1. Perform steps in “Preparing Infusion” section of thisDirections for Use.

2. Press PCA Dose Only soft key from Infusion Modescreen.

3. To enter PCA Dose, use numeric data entry keys.

4. To enter Lockout Interval, press LOCKOUT INTERVAL softkey and use numeric data entry keys.

5. To enter Max Limit, press MAX LIMIT soft key, press YESsoft key and use numeric data entry keys.

NOTE: Time (in hours) associated with Max Limit willautomatically be entered based on set-up in systemconfiguration.

6. To enter Loading Dose, press LOAD DOSE soft key, pressYES soft key and use numeric data entry keys.

NOTE: Loading Dose is included in VTBI but is notincluded in MAX LIMIT.

30 GETTING STARTED

PCA Infusion Modes (Continued)

Setting Up PCA Dose Only (Continued)

[Conc]: 1 mg/mL

None

_ _ _ minutes

MorphinePCA Only

LOCKOUTINTERVAL

MAXLIMIT

AAAAAAAAA

>Select LOCKOUT

INTERVAL

PCADOSE _ 20 mg

LOADINGDOSE None

CHANGEMODE

[Conc]: 1 mg/mL

_ 10 minutes

MorphinePCA Only

LOCKOUTINTERVAL

MAXLIMIT

AAAAAAAAA

>Close and Lock Door Then

Press CONFIRM

20 mg

CONFIRM

PCADOSE

LOADINGDOSE None

CHANGEMODE

None

[Conc]: 1 mg/mL

10 minutes

Guardrails Drug LibraryIMS Pre-fill 30mL

LOCKOUTINTERVAL

MAXLIMIT

AAAAAAAAA

>Enter Max Limit

2 mg

_ _ _ mg/4 h

PCADOSE

LOADINGDOSE None

CHANGEMODE

GETTING STARTED 31


GETTIN

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Setting Up PCA Dose Only (Continued)

7. Verify parameters are correct and press CONFIRM softkey.

NOTES: If the programmed PCA Dose, Lockout Interval,Max Limit or Loading Dose are outside the Guardrails®

Soft Limit, a prompt appears before programming cancontinue. If the Yes soft key is pressed, programmingcontinues; if the No soft key is pressed, the infusion mustbe reprogrammed.

If the programmed PCA Dose, Lockout Interval, MaxLimit or Loading Dose are outside the Guardrails® HardLimit for that care area, a prompt appears beforeprogramming can continue. The infusion must bereprogrammed.

8. Close and lock security door.

9. Verify parameters on second nurse summary screen arecorrect and press START key.

• Infusion mode and PCA drug name scroll in ChannelMessage Display.

• Main Display alternates between Volume Remainingand PCA drug name with infusion mode.

• When PCA dose is delivered:Green Infusing Status Indicator illuminates.Rate display flashes “_ _ _ _ _”.

DELIVERING PCA scrolls in channel message display.When PCA Dose is complete, PCA COMPLETEscrolls in Channel Message Display.

A

Close and lock the door.

>Close and Lock Door

PCA

EXIT

[Conc]: 1 mg/mL

Second Nurse SummaryMorphineAAAAAAAAA

>Press START

STARTPAUSE PRO-GRAM

10 minutesLockoutInterval:

Max Limit:

2 mgPCA Dose:

25 mg/4 h

[Conc]: 1 mg/mL

_ 25 mg/4 h

10 minutes

MorphinePCA Only

LOCKOUTINTERVAL

MAXLIMIT

AAAAAAAAA


Press CONFIRM

2 mg

CONFIRM

PCADOSE

LOADINGDOSE None

CHANGEMODE

32 GETTING STARTED


Setting Up Continuous Infusion Only

AAAA

PCA Dose only

Loading Dose Only

A

Continuous Infusion

>Select an Option



INFUSION MODE

SETUP DRUGLIBRARY

The following procedures should be used when programminga Continuous Infusion Only infusion.


2. Press CONTINUOUS INFUSION soft key from InfusionMode screen.

3. To enter continuous infusion dose, press CONT DOSE softkey and use numeric data entry keys.


NOTE: Time (in hours) associated with Max Limit willautomatically be entered based on set-up in systemconfiguration.

AA

[Conc]: 1 mg/mL

ContinuousMorphine

>Select Max Limit Option

2 mg/h

MAXLIMIT

CONTDOSE

LOADINGDOSE None

CHANGEMODE

> > > >

Yes

No

AA

>Enter Continuous Dose

MAXLIMIT

_ _ _ mg/hCONTDOSE

[Conc]: 1 mg/mL

LOADINGDOSE None

CHANGEMODE

ContinuousMorphine

None

GETTING STARTED 33


Setting Up Continuous Infusion Only (Continued)


NOTE: Loading Dose is included in the VTBI but is notincluded in the MAX LIMIT.


NOTES: If the programmed Continuous Dose, Max Limitor Loading Dose are outside the Guardrails® Soft Limitfor that care area, a prompt appears before programmingcan continue. If the Yes soft key is pressed,programming continues; if the No soft key is pressed, theinfusion needs to be reprogrammed.

If the programmed Continuous Dose, Max Limit orLoading Dose are outside the Guardrails® Hard Limit forthat care area, a prompt appears before programmingcan continue. The infusion needs to be reprogrammed.


8. Verify programming parameters are correct and pressSTART key.

• Green Infusing Status Indicator illuminates.• Infusion mode and drug name scroll in Channel

Message Display. If a Loading Dose has been entered,scrolls DELIVERING LOAD.

• Volume Infused in mL/h in Rate Display• Main Display alternates between volume remaining

and Infusion mode with drug name.

[Conc]: 1 mg/mL

30 mg/4

ContinuousMorphineAAAAAAAAA

2 mg/h

MAXLIMIT

CONTDOSE

LOADINGDOSE > > > >

Yes

No

>Select Loading Dose

OptionCHANGE

MODE

[Conc]: 1 mg/mL

30 mg/4 h

ContinuousMorphineAAAAAAAAA

>Press CONFIRM

2 mg/h

CONFIRM

MAXLIMIT

CONTDOSE

LOADINGDOSE _ _ 1 mg

CHANGEMODE

AA

[Conc]: 1 mg/mL

>Press START

Second Nurse SummaryMorphine

1 mg

STARTPAUSE PRO-GRAM

LoadingDose:

Max Limit:

2 mg/hCont. Dose:

30 mg/4 h

GETTIN

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34 GETTING STARTED


Setting Up PCA Dose + Continuous Infusion

AAAA

PCA Dose only

Loading Dose Only

A

Continuous Infusion


CANCEL



INFUSION MODE

SETUP DRUGLIBRARY

The following procedures should be used when programminga PCA Dose + Continuous Infusion.


2. Press PCA DOSE + CONTINUOUS soft key from InfusionMode screen.

3. To enter PCA Dose, press PCA DOSE soft key and usenumeric data entry keys.

4. To enter Lockout Interval, press LOCKOUT INTERVAL softkey and use numeric data entry keys. AA

[Conc]: 1 mg/mL

>Select CONT DOSE

1 mg

_ _ _ mg/h

PCADOSE

CONTDOSE

MAXLIMIT

_ 10 minutesLOCKOUTINTERVAL

LOADINGDOSE None

CHANGEMODE


None

AA

[Conc]: 1 mg/mL

1 mg

_ _ _ mg/h

PCADOSE

CONTDOSE

MAXLIMIT

_ _ _ minutesLOCKOUTINTERVAL

>Enter Lockout Interval

LOADINGDOSE None

CHANGEMODE

PCA + ContinuousMorphine

None

GETTING STARTED 35


Setting Up PCA Dose + Continuous Infusion(Continued)

5. To enter Continuous Dose, press CONT DOSE soft key,press and use numeric data entry keys.


NOTES: Time (in hours) associated with Max Limit willautomatically be entered based on set-up in systemconfiguration.


NOTE: Loading Dose is included in the VTBI but is notincluded in the MAX LIMIT.


NOTES: If the programmed PCA Dose, Lockout Interval,Continuous Dose, Max Limit or Loading Dose are outsidethe Guardrails® Soft Limit for that care area, a promptappears before programming can continue. If the Yessoft key is pressed, programming continues; if the Nosoft key is pressed, the infusion needs to bereprogrammed.

If the programmed PCA Dose, Lockout Interval,Continuous Dose, Max Limit or Loading Dose are outsidethe Guardrails® Hard Limit for that care area, a promptappears before programming can continue. The infusionneeds to be reprogrammed.


AA

[Conc]: 1 mg/mL

10 minutesLOCKOUTINTERVAL

>Dose 20 Will Exceed Max

Flow Rate

1 mg

_ _2 mg/h

PCADOSE

CONTDOSE

MAXLIMIT

LOADINGDOSE None

CHANGEMODE


None

AA

[Conc]: 1 mg/mL


MAXLIMIT

>Close and lock door then

Press CONFIRM

2 mg/h

1 mg

CONFIRM

_ _ 8 mg/4 h

PCADOSE

CONTDOSE

LOADINGDOSE None

CHANGEMODE


AA

[Conc]: 1 mg/mL


MAXLIMIT

>Press CONFIRM

2 mg/h

CONFIRM

8 mg/4 h

PCADOSE

CONTDOSE

_ 1 mg

LOADINGDOSE None

CHANGEMODE


GETTIN

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36 GETTING STARTED


Setting Up PCA Dose + Continuous Infusion(Continued)

10. Verify parameters on second nurse summary screen arecorrect and press START key.

• During PCA Dose + Continuous Infusion:Green Infusing Status Indicator illuminates.DELIVERING PCA scrolls in Channel MessageDisplay when initiated. Continuous and PCA drugname scrolls in Channel Message Display betweenPCA doses.Volume infused for continuous dose is displayed inml/h in Rate Display.Main Display alternates between volume remainingand Infusion mode with PCA drug name.When PCA Dose is complete, PCA COMPLETEscrolls in Channel Message Display and resumesContinuous dose.

AA

[Conc]: 1 mg/mL

>Press START


STARTPAUSE PRO-GRAM


Max Limit:

2 mg/h

1 mg

Cont. Dose:

PCA Dose:

8 mg/4 h

GETTING STARTED 37


Setting Loading Dose Only

The following procedures should be used when setting aLoading Dose Only using the Guardrails® Drug Library.


2. Press LOADING DOSE ONLY soft key from Infusion Modescreen.

3. Use numeric data entry keys to enter dose value.

4. Verify dose value is correct and then press CONFIRM softkey.

NOTES: Loading dose is included in the VTBI but is notincluded in the Max Limit.

If the programmed Loading Dose is outside theGuardrails® Soft Limit for that care area, a promptappears before programming can continue. If the Yessoft key is pressed, programming continues; if the Nosoft key is pressed, the infusion needs to bereprogrammed.

If the programmed Loading Dose is outside theGuardrails® Hard Limit for that care area, a promptappears before programming can continue. The infusionneeds to be reprogrammed.


Setting Loading Dose from Infusion ModeScreen

AAAA

PCA Dose only

Loading Dose Only

A

Continuous Infusion

>Select an Option



INFUSION MODE

SETUP DRUGLIBRARY

[Conc]: 1 mg/mL

AAAAAAAAA


Press CONFIRM

CONFIRM

LOADINGDOSE _ _ 1 mg

CHANGEMODE


GETTIN

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38 GETTING STARTED


Setting Loading Dose (Continued)

6. Verify parameters on summary screen are correct andpress START key.

• DELIVERING LOAD scrolls in Channel MessageDisplay.

• Infusion mode and Drug name appear in Main Display.• When Loading Dose is complete, The Loading Dose

has Completed appears on Main Display.

7. Press CONFIRM.

• Upon pressing Channel Select on PCA Module,Infusion Mode screen becomes available for selectionof Infusion Mode.

Setting Loading Dose from Infusion ModeScreen (Continued)

AA

[Conc]: 1 mg/mL

>Press START

1 mg

START


PAUSE PRO-GRAM

LoadingDose:

AA

The loading dose hascompleted.

>Press CONFIRM

CONFIRM

GETTING STARTED 39


Setting Bolus Dose

The following procedures should be used only when setting aBolus Dose using the Guardrails® Drug Library.

NOTES: The BOLUS DOSE soft key is only availableonce an infusion has begun in PCA Dose Only,Continuous Infusion, or PCA + Continuous InfusionModes.

1. Press CHANNEL SELECT on PCA Module.

2. Press BOLUS DOSE soft key.

3. Set key to PROGRAM position or enter 4 digitauthorization code and press CONFIRM.

4. Use numeric data entry keys to enter dose value.

5. Press CONFIRM.

NOTES: If the programmed Bolus Dose is outside theGuardrails® Soft Limit for that care area, a promptappears before programming can continue. If the Yessoft key is pressed, programming continues; if the Nosoft key is pressed, the infusion needs to bereprogrammed.

If the programmed Bolus Dose is outside the Guardrails®

Hard Limit for that care area, a prompt appears beforeprogramming can continue. The infusion needs to bereprogrammed.

[Conc]: 1 mg/mL

Max Limit:

AAAAAAAAA

>Press START to Close

Summary

2 mg/h

STARTBOLUSDOSE

Cont. Dose

30 mg/4 h

PRO-GRAM

SummaryMorphine

CONFIRM

>Set Key to PROGRAM

position or enter code

* * * *

Set key to ‘Program’position or enterauthorization code:

AAAAAAAAA PCA

[Conc]: 1 mg/mL

AAAAAAAAA

DOSE

>Enter BOLUS Dose

_ _ _ mg

BOLUS DOSE

Morphine

GETTIN

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40 GETTING STARTED


Setting Bolus Dose (Continued)

6. If Authorization Code is disabled, door must be lockedprior to starting Bolus Dose.

7. Verify dose value is correct and then press START softkey:

• Delivering Bolus scrolls in Channel Message Display• Bolus and drug name appears in Main Display• When Bolus Dose is complete, BOLUS COMPLETE

scrolls in Channel Message Display.• Programmed infusion resumes.

Stopping a Loading, PCA or Bolus Dose

The following procedure should be used to stop a Loading,PCA or Bolus Dose.

1. Press CHANNEL SELECT key on PCA Module.

2. Press STOP LOAD, STOP PCA or STOP BOLUS softkey as applicable.

NOTE: Soft key will reflect the type of dose that iscurrently infusing.

3. To stop dose and resume current program, press YESsoft key.

BOLUSDOSE

[Conc]: 1 mg/mL

Guardrails Drug LibraryIMS Pre-fill 30mLAAAAAAAAA

1 mgBolusDose:

Max Limit:

2 mg/hCont. Dose:

30 mg/4 h

>Press START

STARTPAUSE PRO-GRAM

GETTING STARTED 41


Changing Programming Parameters During an Infusion

The following procedures should be used only when changingprogramming parameters during an infusion.


2. Press PROGRAM soft key.

3. Set key to program position or if Authorization Code isenabled, enter 4 digit code.

A

VOLUMEINFUSED

AUDIOADJUST


PCA + Cont Morphine

[Conc]: 1 mg/mL

20 minutes

SummaryMorphine

LockoutInterval:

Max Limit:

AAAAAAAAA


Summary

2 mg

STARTBOLUSDOSE

PRO-GRAM

PCA Dose

25 mg/4 h

2 mg/hCont. Dose:

[Conc]: 1 mg/mL

20 minutes

SummaryMorphine

LockoutInterval:

Max Limit:

AAAAAAAAA

>Press START

2 mg

STARTBOLUSDOSE

PRO-GRAM

PCA Dose

25 mg/4 h

2 mg/hCont. Dose:

A PCA

>Set Key to PROGRAM

Position

Set key to ‘Program’position.

EXIT

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42 GETTING STARTED


Changing Programming Parameters During an Infusion(Continued)

4. Press CHANGE MODES softkey.

5. Select desired Infusion Mode.

6. Continue programming as outlined in Setting Up PCADose Only, PCA + Continuous Infusion or ContinuousInfusion Only sections.

NOTE: Previously programmed values are carried overto new program.

7. Verify or change program settings and press CONFIRMkey.

8. Close and lock door.

AA

25 mg/4 h

CONTDOSE

[Conc]: 1 mg/mL

MAXLIMIT

2 mg/h

CHANGEMODES



2 mgPCADOSE


Press CONFIRM

CONFIRM

AAAA

PCA Dose only

A

> Select an Option or

Cancel



Continuous Infusion

INFUSION MODE

SETUP

AA

[Conc]: 1 mg/mL

>Press START

START

Guardrails Drug LibraryMorphine

PAUSE PRO-GRAM


Max Limit:

2 mgPCA Dose:

25 mg/4 h

BOLUSDOSE

GETTING STARTED 43


Viewing Patient History

The following procedures should be used to view patienthistory.


2. From Main Display, press OPTIONS key.

A

VOLUMEINFUSED

AUDIOADJUST


Cont Morphine

[Conc]: 1 mg/mL

SummaryMorphine

Max Limit:

AAAAAAAAA


Summary

STARTBOLUSDOSE

PRO-GRAM

25 mg/4 h

2 mg/hCont. Dose:

Changing Programming Parameters During an Infusion(Continued)

AA

[Conc]: 1 mg/mL

>Press START

START


PAUSE PRO-GRAM


Max Limit:

2 mgPCA Dose:

25 mg/4 h

BOLUSDOSE

9. Verify programming parameters on summary screen arecorrect and press START key.

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44 GETTING G STARTED


Viewing Patient History (Continued)

3. Press Patient History soft key.

4. Press ZOOM soft key to select desired time period.

• Patient History contains:Total Drug Delivered.Total Demands.Delivered (demands).

NOTE: Total Drug Delivered includes applicable LoadingDose, PCA Dose, Continuous Dose, and Bolus Dose.Total Drug Delivered does not include priming volume.

5. Press DETAIL soft key to view Detailed Patient History.

• Detailed Patient History contains:Total Drug Delivered.Total Drug Delivered via:

PCA Dose.Continuous Infusion.Loading Dose.Bolus Dose.Average Drug Per Hour.

6. To return to Main Patient History, press MAIN HISTORYsoft key.

Total Demands:

Total Drug:

AAAAAAAAA

ZOOM EXIT

Delivered:

>Press ZOOM to Change

Time Scale

DETAIL

Patient History 09:01

CLEARHISTORY

LASTCLEARED

07:002003-6-10

History from 07:01 - 09:01

ZOOM: 24 12 8 4 1 hours2

SHIFT TOTALS

22 mg

52

A


EXIT

EXIT

Dose Request Setup

Infusion Modes

Patient History

PCA Guardrails Setup

Drug Event History


PAGEDOWN

Total Drug: 22 mg

Loading Dose: 2 mg

Continuous Infusion: 4 mg

Average Drug per Hr: 11 mg

AAAAAAAAA

ZOOM EXIT

PCA Dose: 14 mg

Bolus Dose: 2 mg


Time ScaleMAIN

HISTORY

Morphine1mg/mL


ZOOM: 24 12 8 4 1 hours2

Total Demands:

Total Drug:

AAAAAAAAA

ZOOM EXIT

Delivered:


Time Scale

DETAIL


CLEARHISTORY

LASTCLEARED

07:002003-6-10


ZOOM: 24 12 8 4 1 hours2

SHIFT TOTALS

22 mg

52

GETTING STARTED 45


Viewing Patient History (Continued)

[Conc]: 1 mg/mL

SummaryMorphine

Max Limit:

AAAAAAAAA


Summary

STARTBOLUSDOSE

PRO-GRAM

25 mg/4 h

2 mg/hCont. Dose:

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7. To return to Main Display, press EXIT soft key.

NOTE: The Patient History stores a rolling 24 hour log.Patient history is automatically cleared upon selection of"New Patient?", "Yes", in "Start Up" Section, or uponchanging drug selection in Guardrails® Drug Library.

Clearing Patient History

The following procedures should be used to clear patienthistory.

1. Press CLEAR HISTORY soft key.A confirmation screen appears.

2. To continue and clear patient history, press YES soft key.To cancel and return to patient history, press NO soft key.

Total Demands:

Total Drug:

AAAAAAAAA

ZOOM EXIT

Delivered:


Time Scale

DETAIL


CLEARHISTORY

LASTCLEARED

07:002003-6-10


ZOOM: 24 12 8 4 1 hours2

SHIFT TOTALS

22 mg

52

A

>Press Yes or No

Are you sure youwould like to clearthe Patient History?

Yes

No

PCA

46 GETTING STARTED


Clearing Patient History (Continued)

3. Once patient history is cleared, the last 24 hours ofpatient history data may be retrieved and viewed.Select 24 h Totals soft key from Patient History screen toretrieve the last 24 hours.

4. Press SHIFT TOTALS soft key to return to Patient Historyview.

NOTE: The 24 h Totals soft key appears only if the shifttotal is cleared and additional patient history informationexists (up to the previous 24 hours).

ShiftTotals

Total Demands:

Total Drug:

AAAAAAAAA

ZOOM EXIT

Delivered:


Time Scale

LASTCLEARED

09:012003-6-10


ZOOM: 24 12 8 4 1 hours2

24 h TOTALS

22 mg

52

Morphine1mg/mL

Morphine1mg/mL


AAAAAAAAA

ZOOM EXIT


Time Scale

DETAILCLEAR

HISTORY

ZOOM: 24 12 8 4 1 hours2

24 hTotals

Total Demands:

Total Drug:

Delivered:

LASTCLEARED

09:012003-6-10

SHIFT TOTALS

0 mg

00

The following procedures should be used to view detaileddrug event history.



3. Press Drug Event History soft key.

4. Press PAGE DOWN soft key to scroll through history.

5. To return to Main Display, press EXIT soft key.

NOTE: The Drug Event History stores approximately 12hours of events. Drug Event History is automaticallycleared upon selection of “New Patient?”, “Yes”, in “Start-Up” section.

GETTING STARTED 47

GETTIN

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Viewing Drug Event History

[Conc]: 1 mg/mL

SummaryMorphine

Max Limit:

AAAAAAAAA

>Press START

STARTBOLUSDOSE

PRO-GRAM

25 mg/4 h

2 mg/hCont. Dose:

A

VOLUMEINFUSED

AUDIOADJUST


Cont Morphine

A


EXIT

Dose Request Setup

Infusion Modes

Patient History


Drug Event History


PAGEDOWN

A

>Press PAGE DOWN or

PAGE UP to View Events

TIMEDRUG EVENTMorphine (1mg/mL)

2003-06-10

07:08

07:08

06:10

09:01 PCA Dose, 1 mg

Continuous, 2 mg/h

Bolus Dose stopped

08:38

PCA + Cont infusion

08:08 New syringe

Unmet demands - 5

Bolus Dose, 1mg

History cleared

06:08

06:00

Drug Event History 1

EXITPAGEDOWN

48 GETTING STARTED

The Dose Request Cord can be configured to provide bothaudio and visual prompts to the patient. Visual prompts areprovided through the LED indicator on the Dose RequestCord.

Default configuration for the Dose Request Cord isestablished in the system configuration.

To change the Dose Request Cord configuration:



3. Press Dose Request Setup soft key.


Configuring Dose Request Cord

SummaryMorphine

[Conc]: 1 mg/mL


Max Limit:

AAAAAAAAA

>Press START

2 mg

STARTBOLUSDOSE

PCA Dose

25 mg/4 h

PRO-GRAM

A

VOLUMEINFUSED

AUDIOADJUST


PCA Morphine

A


EXIT

EXIT

Dose Request Setup

Infusion Modes

Patient History


Drug Event History


PAGEDOWN

GETTING STARTED 49

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4. Review and select the Profile soft key for the desiredoperation of the dose request cord.


Configuring the Dose Request Cord (Continued)

Select the desiredfunctional profile for theoperation of theDose Request Cord.

-Audio: good demandsVisual: PCA available ON

PCA delivery FLASHESLockout interval OFF

Profile 1

Profile 2

Profile 3

Profile 1

CONFIRM

>Select an Option

Dose Request SetupA

5. Press CONFIRM soft key.

PROFILE 1 PROFILE 2 PROFILE 3Dose Request CordAudio - Single Beep

Met demands only All Demands All Demands

Dose Request CordLED Indicator:PCA Available ON ON OFFPCA Delivery “ON-FLASHING” ON OFFLockout Interval OFF ON OFF

50 GETTING STARTED


Security Access Levels

The security access level can be configured to providevarying levels of access to the device. Security access isaccomplished either through the use of the key or a four-digitauthorization code.

Default configuration for the security access level isestablished for each profile or care area and can be changedin the system configuration. The four-digit authorization codeis established and can be changed in the systemconfiguration.

The four-digit authorization code is the same for all profileswith Level 2 or Level 3 security access.

Security Access Level Initial Programming Setting Bolus Dose Subsequent Programming

Level 1 Key Key Key Level 2 Key Code or Key Key Level 3 Key Code or Key Code or Key

The security code may be disabled for a specific infusion byusing the following procedure:



3 Press Security Code Access soft key.

4. Press DISABLE CODE soft key.


The security access code will remain disabled until “NewPatient? Yes” is selected in the Start-Up of an infusion or ifthe unit remains powered off for more than eight hours.

A


EXIT




Security Code Access

PAGEUP

A

Security Code Access

>Press DISABLE CODE or

EXIT

Press DISABLE CODE totemporarily turn off code accesscapabilities for current patient.

EXIT

DisableCode

CONFIRM

GETTING STARTED 51

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Pausing Infusion

1. Press PAUSE key on PCA Module.

ORFrom Second Nurse Summary screen, press PAUSE softkey.

• PAUSE scrolls in Channel Message Display.• PAUSED appears on Main Display.• Yellow Standby Status Indicator illuminates.• After two minutes, “PAUSE-RESTART CHANNEL” visual

and audio prompts begin, and yellow Standby StatusIndicator flashes.

2. To reinitiate infusion:

• Press RESTART key on PCA Module.

OR

• Press CHANNEL SELECT key and then press STARTsoft key on Main Display.

AA

[Conc]: 1 mg/mL

>Press START

START


PAUSE PRO-GRAM


Max Limit:

2 mg/h

2 mg

Cont. Dose:

PCA Dose:

20 mg/4 h

BOLUSDOSE

AA

[Conc]: 1 mg/mL

>Press START

START


PAUSE PRO-GRAM


Max Limit:

2 mg/h

2 mg

Cont. Dose:

PCA Dose:

20 mg/4 h

BOLUSDOSE

52 GETTING STARTED


Restoring Infusion Following Syringe Empty

EXIT

A

>Select Drug/Concentration

or Restore Previous Infusion

A

Morphine 1 mg/mL

Morphine 5 mg/mL

Meperidine 10 mg/mL


RESTORE

AA

[Conc]: 1 mg/mL


MAXLIMIT


Press CONFIRM

2 mg

CONFIRM

25 mg/4 h

PCADOSE

CHANGEMODE


1. If syringe requires replacement:

a. Unlock security door.

b. Remove existing syringe and prepare new syringe(reference “Preparing Syringe and Administration Set”section).

c. Load syringe and administration set (reference“Preparing Infusion” section).

d. Select syringe type and size (reference “PreparingInfusion” section).

e. Prime (reference “Preparing Infusion” section).

2. To restart infusion using restored parameters, pressRESTORE soft key and continue with next step.

OR

To start a new infusion, select drug from the Guardrails®

Drug Library and follow steps for PCA Infusion Modes.

3. For restored parameters, verify parameters are valid andpress CONFIRM soft key.

NOTE: To change a restored parameter:

a. Press applicable soft key.b. Enter desired parameter using numeric data entry keys.c. Press CONFIRM soft key.

Press and hold CHANNEL OFF key on PCA Module for 1second, until a beep is heard.

NOTE: If no other channel is active, the System powers downwhen the CHANNEL OFF key is released.

GETTING STARTED 53

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Stopping Infusion


Selecting Pressure Limit

Restoring Infusion Following Syringe Empty (Continued)


5. Verify programming parameters on summary screen arecorrect and press START key.

[Conc]: 1 mg/mL

Second Nurse SummaryMorphineAAAAAAAAA

>Press START

STARTPAUSEPRO-GRAM


Max Limit:

2 mgPCA Dose:

25 mg/4 h


2. Press OPTIONS key.

3. Press Pressure Limit soft key.

NOTE: Option can be selected to change pressurelimit:

• Before Infusion Mode is selected.• Before Infusion starts.

A


EXIT




PAGEUP

54 GETTING STARTED

Viewing and Clearing Volume Infused

1. To view volume infused, press VOLUME INFUSED soft keyfrom the Main Display.

• Total volume infused, and time and date volumeinfused was last cleared is displayed for each channel.

NOTE: Date format is year-month-day.

2. To clear volume infused:

NOTE: If no key is pressed, main screen appears after30 seconds.

• If only selected channels are to be cleared, press softkey next to applicable channel(s) and press CLEARCHANNEL soft key.

Volume clears on selected channel(s).

• If all channels are to be cleared, press CLEAR ALL softkey.

• To return to main screen, press MAIN SCREEN soft key.

NOTE: Clearing volume infused on a PCA Module does notclear patient history.


4. To select a pressure limit, press appropriate soft key(Low, Med, or High).


Selecting Pressure Limit (Continued)

A

Pressure Limit Selection

CONFIRM

Low

High

Med

A

C

D

B

CLEARALL

MAINSCREEN

Volume Infused

>Select Channels to Clear

or Press CLEAR ALL

TOTAL VOLUME (mL)LAST

CLEARED

08:001998-3-10

07:301998-3-11

08:001998-3-10

12:001998-3-10

PRI/SECVOLUME

401.10

42.50

478.10

789.10

A

VOLUMEINFUSED

AUDIOADJUST


PCA Morphine

GETTING STARTED 55

GETTIN

G STA

RTED


Changing Syringe During Infusion

1. To stop infusion, press PAUSE key on PCA Module.

2. Unlock the door.

3. Open plunger grippers and syringe barrel clamp.

• An audio prompt sounds.• Red Alarm Status Indicator flashes.• CHECK SYRINGE scrolls in Channel Message Display.

4. Remove syringe and separate administration set fromsyringe.

NOTE: If drug and/or drug concentration is different fromprevious syringe, attach and prime new administration set.

5. Reattach administration set to new syringe (refer to“Preparing Infusion” section).

6. Load new syringe (refer to “Preparing Infusion” section).

7. Select syringe type and size (refer to “Preparing Infusion”section).


9. Prime administration set (refer to “Preparing Infusion”section).

10. Press RESTORE soft key, press NEXT soft key, andconfirm programming parameters.

ORPress applicable soft key and use numeric data entrykeys.

11. Lock the door.

12. To begin infusion, press START soft key.

56 GETTING STARTED

Powering Off

Powering Off System

Powering Off Channel



ALA

RM

S, ERR

OR

S, M

ESSAG

ES

ALARMS, ERRORS, MESSAGES 57

ALARMS, ERRORS, MESSAGES

Advisory A sequence of audio and/or visual signals indicating the operatingstatus of the Medley™ Medication Safety System. The audio may besilenced for approximately two minutes by pressing the SILENCE key.

Alarm An audio and visual signal that a potentially unsafe condition ispresent. Immediate action is required. The audio may be silenced forapproximately two minutes by pressing the SILENCE key.

Error An audio and/or visual signal that a failure has been detected.Immediate action is required.

Guardrails® Alert A visual message to help reduce programming errors by indicating aGuardrails® Limit (“soft” or “hard”) has been exceeded. A response isrequired before programming can continue.

Guardrails® Clinical Advisory A visual message when a designated drug is selected, to remindclinician of specific hospital standards of practice when programmingan IV medication. A specific clinical advisory can be associated with aselected drug within any of the patient care profiles.

Maintenance Reminder A visual message that, when enabled, appears at startup whenscheduled preventive maintenance is due/overdue for any part of theMedley™ System (Point-of-Care Unit or attached module).

Prompt A visual message, appearing on the bottom line of the Main Display orin the Message Display. The message may be accompanied by anaudio signal that can be silenced for twelve seconds by pressing theSILENCE key.

To enhance safety and ease of operation, the Medley™ System provides a full range of audio and visualalarms, errors, and messages.

Definitions

58 ALARMS, ERRORS, MESSAGES

Audio Characteristics

Advisory

Alarm

Error (Hardware Detected)

Error (Software Detected)

Illegal Key Press

Key Click

Prompt

Switchover

One short beep every two seconds

Choice of three alarm audioprofiles, selectable in SystemConfiguration

Pairs of long beeps

Pairs of long beeps

Two short beeps

One short beep

One short beep every two seconds

Two short beeps (e.g. Bolusswitching to Continuous).

Variable volume; can be silencedfor two minutes.

Variable volume; can be silencedfor two minutes.

Fixed maximum decibel volume;cannot be silenced.

Fixed maximum decibel volume;can be silenced for two minutes.

Variable volume; cannot besilenced.

Fixed minimum volume; can besilenced and disabled in SystemConfiguration.

Variable volume; can be silenced.

Variable volume; can be silencedand disabled in SystemConfiguration.

The Point-of-Care Unit and Main Display provide various types of alert information. The characteristicsof the accompanying audio sounds are as follows:

Type Sound Notes


ALA

RM

S, ERR

OR

S, M

ESSAG

ES

Alarms

Attach Dose Request Cord

Channel Disconnected

Check Syringe

Lock Door

Occlusion

Syringe Empty

Unit Location Alarm

Dose Request Cord is detachedfrom device. Dose Request Cordis required for PCA only andPCA+Continuous Infusion modes.

Channel(s) disconnected while inoperation or have a communicationproblem.

Plunger grippers opened duringinfusion and then closed. Infusionstops on affected channel.

Syringe barrel clamp openedduring infusion and then closed.Infusion stops on affected channel.

Syringe plunger not captured whilein idle state. System alarmsimmediately to indicate potentialsiphoning condition.

If security door is closed andsyringe plunger is not captured, thesystem will immediately alarm.

Door unlocked during infusion.System will not infuse with doorunlocked.

Increased back pressure sensedwhile infusing. Infusion stops onaffected channel.

Syringe is empty.

If syringe is not empty, the syringe plunger travel may beimpeded.

PCA Module is not in the preferablelocation to allow locking to thePoint-of-Care Unit. Device is not ina tamper evident position.

Reattach Dose Request Cord andpress RESTART key.

To silence alarm and clearmessage from screen, pressCONFIRM soft key. Reattachchannel, if desired, ensuring it issecurely “clicked” into place atChannel Release Latch. If alarm isstill present, replace channel withan operational instrument.

Securely lock plunger grippers,press CHANNEL SELECT key, andreselect syringe.

Securely lock syringe barrel clampand press RESTART key.

Check for potential siphoning.Ensure administration set clamp(roller/slide) is in closed position.Securely lock plunger grippers oversyringe plunger.

Lock door and press RESTART key.

Clear occlusion, press RESTARTkey or appropriate select control,and then press START soft key.

Set up new infusion or pressCHANNEL OFF key.

Verify syringe plunger movement isunimpeded.

Detach PCA Module from currentposition and reattach to theimmediate right of the Medley™

Point-of-Care Unit.


When a syringe installation problem is detected, a visualsignal is displayed. Text in the display blinks to indicate thelocation of the problem.

• When problem is corrected, press CONFIRM soft key.

Check Syringe

Drive Not Engaged

Plunger grippers opened duringinfusion and then closed. Infusionstops on affected channel.

Syringe barrel clamp openedduring infusion and then closed.Infusion stops on affected channel.

Syringe plunger not captured whilein idle state. System alarms after30 seconds, to indicate potentialsiphoning condition.

If security door is closed andsyringe plunger is not captured, thesystem will immediately alarm.

Drive system disengaged duringoperation.

Securely lock plunger grippers,press CHANNEL SELECT key, andreselect syringe.

Securely lock syringe barrel clampand press RESTART key.

Check for potential siphoning.Ensure administration set clamp(roller/slide) is in closed position.Securely lock plunger grippers oversyringe plunger.

Open and close plunger grippers.Ensure syringe is properly installed.

Alarm Meaning Response

Alarms (Continued)

Syringe Adjustment Alarms



>Check Syringe

CONFIRM

Syringe Installation

plunger

flange

clamp

lever



Syringe Installation

>Press CONFIRM

CONFIRM

plunger

flange

clamp

lever

ALA

RM

S, ERR

OR

S, M

ESSAG

ES

Channel Error

Syringe Calibration Required

Syringe Driver Head Error

Error detected on infusing channel.Infusion stops on affected channel.

Error on infusing channel indicatingcalibration is required. Infusionstops on affected channel.CALIBRATE scrolls in ChannelMessage Display.

Noninfusing channel, with plungergrippers open, senses excessivepressure being applied downwardon Drive Head. OCCLUSION scrollsin Channel Message Display.

To silence alarm and continueoperation of unaffected channels,press CONFIRM soft key. Replacechannel with an operationalinstrument, as required. Service byqualified personnel is required.

To silence alarm and continueoperation of unaffected channels,press CONFIRM soft key. Replacechannel with an operationalinstrument, as required. Service byqualified personnel is required.

To silence alarm and continuenormal operation, press CONFIRMsoft key.

Errors

Error Meaning Response

Bolus Complete

Infusion Complete

Load Complete

Max Limit Reached

NEOI (Near End of Infusion)

Current Bolus Dose completed.Channel running in ContinuousDose if programmed.

Current infusion completed.

Current Loading Dose completed.Infusion mode menu available orprogrammed infusion running.

Programmed Max Limit has beenreached over time period specified.Infusion paused until time limit hasexpired.

Syringe almost empty.

None

Set up a new infusion or pressCHANNEL OFF key.

None

None. This is a timed event thatcan be set. To change Max Limit,press CHANNEL SELECT, pressSETUP soft key, and unlock door orenter Authorization Codeapplicable for current SecurityAccess Level.

None. This is a timed event thatcan be set. To set or change thisoption, see “Configurable Settings”section.

Message Meaning Response

Messages



Messages (Continued)

Message Meaning Response

Panel Locked

Panel Unlocked

Pause

PCA Complete

Syringe Not Recognized

Tamper Resist feature is active anda key was pressed.

Tamper Resist feature deactivated.

Pause control pressed, infusionstopped.

Current PCA Dose complete.Lockout interval begins. Channelrunning in Continuous Dose ifprogrammed.

Installed syringe of unknown typeand size.

If appropriate, deactivate TamperResist feature using Tamper ResistControl on back of Point-of-CareUnit.

None.

To resume infusion, pressRESTART key.

None

Select and confirm correct syringetype and size, and then pressCONFIRM; or use a syringe typeand size that system canautomatically and correctly identify.Ensure compatible syringe isloaded. For a list of compatiblesyringes, refer to Compatible Setssection of this Directions for Use.

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MAINTENANCE 63

Medley™ System Technical Service Manuals are available from ALARIS Medical Systems. They includeroutine service schedules, interconnect diagrams, component parts lists and descriptions, testprocedures and/or references, and other technical information, to assist qualified service personnel inrepair and maintenance of each instrument’s repairable components. Maintenance procedures areintended to be performed only by qualified personnel, using the service manual and Medley™

Maintenance Software.

Specifications

Bolus Dose Range Configured according to hospital best practice guidelines.

Delivery Units mg, mcg, mL, mg/h, mcg/h, mL/h

Critical Volume: The maximum over-infusion which can occur in the event of a single-fault conditionwill not exceed 2% of nominal syringe fill volume during loading and 1% ofmaximum syringe travel after syringe loading.

Dimensions: 4.5" W x 15.0" H x 7.5" D (exclusive of security door).

Environmental Conditions: Operating Storage/Transport

Temperature Range: 41 to 104°F -4 to 140°F(5 to 40°C) (-20 to 60°C)

Relative Humidity: 20 to 90% 5 to 85%(Avoid prolonged exposure Noncondensing Noncondensingto relative humidity >85%)

Atmospheric Pressure: 525 to 4560 mmHg 375 to 760 mmHg(700 to 6080 hPa) (500 to 1013 hPa)

Equipment Orientation: To ensure proper operation, the Point-of-Care Unit must remain in an uprightposition.

Flow Rate Programming: The flow rate range is from 0.1 to 999 mL/h as follows:

Flow Rates (mL) Selectable Increments (mL/h)0.10 - 9.99 0.0110 - 99.9 0.1100 - 999 1.0

Rate Restriction by Syringe Size:

Syringe Size (mL) Flow Rate Range (mL/h)50/60 0.1 - 99930/35 0.1 - 650

20 0.1 - 500

Fluid Ingress Protection: IPX1, Drip Proof

Loading Dose Range: Configured according to hospital best practice guidelines.

64 MAINTENANCE

Specifications (Continued)

Max Limit Range: Configured according to hospital best practice guidelines.

Occlusion Alarm Thresholds: Three settings:

LowMediumHigh

Operating Principle: Positive displacement

PCA Dose Range: Configured according to hospital best practice guidelines.

Rate Accuracy: The Medley™ PCA Module accuracy rate is ±2% of full scale plunger travel (notincluding syringe variation).

Shock Protection: Type CF, Defibrillator Proof (PCA Module)

Type BF, Defibrillator Proof (Dose Request Cord)

Syringe size and running force, variations of back pressure, or any combination ofthese may affect rate accuracy. Factors that can influence back pressure are:Administration set configuration, IV solution viscosity, and IV solution temperature.Back pressure may also be affected by type of catheter. Refer to “Trumpet andStart-Up Curves” section in the Appendix for data on how these factors influencerate accuracy.

WARNING

Time to Alarm, Maximum:

Occlusion Pressure Limit

Rate (mL/h) High Low

1 120 minutes 37 minutes

5 30 minutes 7 minutes

NOTE: The Maximum Time to Alarm specifications are based on ALARISMedical Systems’ standard operating conditions:

Atmospheric Pressure: 645 - 795 mmHgBack Pressure: 0 mmHg before producing occlusionHumidity: 20 - 90%Temperature: 68 ±4° F

Bolus Volume afterOcclusion, Maximum:

Weight: 5.5 lbs

MAINTENANCE 65

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Configurable Settings

If the configuration settings need to be changed from theFactory Default settings, refer to the Guardrails® EditorSoftware User Manual or contact ALARIS Medical Systems,Technical Support, for technical, troubleshooting, andpreventive maintenance information.

NOTE: With the Profiles feature enabled, the settings areconfigured independently for each profile. A hospital-defineddata set must be uploaded to enable the Profiles feature. Dateand Time is a system setting and is the same in all profiles.

Specifications (Continued)

NOTE: Compliance to StandardsThe Medley™ Medication Safety System complies with the following standards: UL 60601–1, including A1and A2; CSA C22.2 No. 601.1, including A1 and A2; IEC/EN 60601–2–24; IEC/EN 60601–1–2, and AAMI ID26.

System Settings


Bolus Volume at Intermediate Rate (5 mL/h)

Occlusion Pressure Limit Bolus Volume

High .997 mL

Low .396 mL

66 MAINTENANCE

4-digits between 0-9One code applies to all profiles

75 -500 mL/hr (limited by syringesize

Enabled - Disabled

Enabled - Disabled

Profile A, B, C

Enabled - Disabled

Min/Max 1-180 minutes

Disabled/1, 2 or 4 hour limit

0.1 - 99.9 mL/h in 0.1 mL/hincrements; 100 - 999 mL/h in

1 mL/h increments

Enabled - Disabled5 - 25% of remaining infusion

Low (200 mmHg)Medium (500 mmHg)

High (800 mmHg)

Enabled - Disabled

Enabled - Disabled

Level 1, 2, 3

Authorization Code

Bolus Delivery Rate

Bolus Dose

Bolus Dose include in Max.Limit

Dose Request CordConfiguration

Loading Dose

Lockout Interval

Max Accumulated DoseRange

Max Rate

NEOI

• Alert Time

Occlusion Pressure SetPoint:

Priming

Forced Module Location

Security Access Level

None

150 mL/hr

Enabled

Disabled

Profile B

Enabled

1 - 180 minutes in 1minute increments

1 hour limit

999 mL/h

Disabled

High (800 mmHg)

Disabled

Enabled

Level 1

PCA Module Settings

Configurable Settings (Continued)

Feature Default Setting Options

Compatible Syringes

The Medley™ PCA Module is calibrated and labeled for usewith the following single-use disposable luer-lock syringes.Use only the syringe size and type specified on the MainDisplay. The full list of permitted syringe models is dependenton the PCA Module’s software version.

1 Prefilled Morphine Sulfate 1 mg/ml.

*NOTE: Syringe variability may impact occlusion pressuresensing. The variability may reduce the device’s time toalarm and/or may require that a higher alarm pressure limitbe programmed.

20cc 30cc

1

35cc 50cc 60ccManufacturerB-D Plastipak

IMS Pump Jet*

Monoject

Terumo

Compatible Sets

Use only standard, single-use,disposable non-dedicatedadministration sets with anti-siphonvalves, designed for use on syringe-type PCA devices. The use ofincompatible administration set maycause improper instrumentoperation, resulting in inaccuratefluid delivery or other potentialhazards.

WARNINGThe following administration sets are for use with theMedley™ PCA Module. For additional configurations, contactALARIS Medical Systems Customer Care at (800) 482-4822.

MODEL SET DESCRIPTION

30843E PCA Extension Set 12" - Y-Connector with SmartSite® Needle-Free Valve Port and backcheck valve

30853 PCA Administration Set 70" - Microbore w/Anti-siphon valve, Y-Connector with backcheck valve

30863 PCA Administration Set 63" - Microbore w/Anti-siphon valve

30873 PCA Administration Set 90" - Microbore w/Anti-siphon valve, Y-Connector with backcheck valve

30883 PCA Administration Set 92" - Microbore w/Anti-siphon valve

30893 PCA Administration Set 113" - Microbore w/yellow-striped tubing and anti-siphon valve

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68 MAINTENANCE

Cleaning

Inspection Requirements

To ensure the system remains in good operating condition, bothregular and periodic inspections are required.

Regular inspections consist of a visual inspection for damageand cleanliness, and performing the procedure described in the“Start-Up” section of this Directions for Use before each usage ofthe instrument. Regular inspections must be performed by thehospital/facility and if any damage is found, service is required.

REGULAR INSPECTIONSPROCEDURE FREQUENCYINSPECT FOR DAMAGE:

Exterior Surface Each usagePole Clamp Each usagePower Cord Each usageKeypad Each usage

CLEANING As requiredSTART-UP Each usage

1. Exterior Surfaces - examine for overall condition and verify:• There is no damage, cracks or deformities.• Case is clean and free from IV solution residue.• Labels and markings are legible.• No tape or other foreign material is on sides of case;

anything of this nature could prevent proper latching ofmodules.

• IUI Connectors have not been damaged.

2. Pole ClampPole Clamp should be secure and functioning.

3. Power Cord Assembly - examine for:• Signs of damage, cuts or deformities in cord. If

damaged, replace entire cord.• Integrity of hospital-grade power plug. Attempt to wiggle

blades, to verify they are secure. If any damage issuspected, replace entire cord.

4. KeypadCheck membrane switches for damage.

Periodic inspections of the hardware are required. For detailedinstructions on performing periodic inspections and maintenance,refer to the Medley™ Medication Safety System Technical ServiceManual and supplemental service bulletins, and Medley™

Maintenance Software.

Failure to perform these inspectionsmay result in improper instrumentoperation.

WARNING

Periodic inspections should only beperformed by qualified servicepersonnel.

CAUTION

Refer to the Medley™ Point of Care Unit Directions for Use.

MAINTENANCE 69

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Technical support, service information, applications, andmanuals may be obtained by contacting an ALARIS MedicalSystems representative.

United States (800) 854-7128, extension 6003Canada:

Eastern (800) 908-9918Western (800) 908-9919

When submitting any request for service, include:

• full description of difficulty experienced• instrument settings• administration set/lot number• solution(s) used• message displayed at time of difficulty

Customer Service

Information or assistance may be obtained by calling one ofthe following Customer Service numbers:

United States (800) 482-4822Canada: (800) 387-8309

NOTE: If the instrument shows evidence of damage in transit,notify the carrier’s agent immediately. Do not return damagedequipment to the factory before the carrier’s agent hasauthorized repairs.

If the instrument fails to respond as described in thisdocument and the cause cannot be determined, do not usethe instrument. Contact ALARIS Medical Systems TechnicalSupport.

Instruments returned from theservice depot to your facility may beset to factory defaults and not havea hospital-defined data set loaded.Biomedical personnel in the facilityare responsible for checking-in theinstrument and ensuring the currenthospital-approved data set isloaded.

WARNING

Service Information

Technical Support

Product Return

If it is necessary to return the instrument for service, obtain areturn authorization number prior to shipment. Carefullypackage the instrument (preferably in the original packaging),reference the return authorization information, and return it tothe appropriate service or distribution center. ALARIS MedicalSystems does not assume any responsibility for loss of, ordamage to, returned instruments while in transit.

70 MAINTENANCE


L E F T B L A N K

APPEN

DIX

APPENDIX

APPENDIX 71

Trumpet and Start-Up Curves

In this instrument, as with all infusion systems,the action of the pumping mechanism andvariations in individual syringes andadministration sets cause short-termfluctuations in rate accuracy. The followinggraphs show typical performance of the system,as follows:

1. Accuracy during various time periods overwhich fluid delivery is measured (trumpetcurves).

2. Delay in onset of fluid flow when infusioncommences (start-up curves).

Trumpet and start-up curves have beenprovided for 0.1 mL/h, 1.0 mL/h and 5.0 mL/h.Measurements for trumpet curve rates above5.0 mL/h are also not provided, as the volumeof the syringe will be displaced in a very shorttime with a rate of up 999 mL/h. Accuracy,however, is assured with the designimplementation.

Trumpet curves are named for theircharacteristic shape. They display discreteaccuracy data averaged over particular timeperiods or “observation windows”, notcontinuous data versus operating time.

Over long observation windows, short-termfluctuations have little effect on accuracy, asrepresented by the flat part of the curve. As theobservation window is reduced, short-termfluctuations have greater effect, as representedby the “mouth” of the trumpet. Knowledge ofsystem accuracy over various observationwindows may be of interest when certain drugsare being administered.

Because the clinical impact of short-termfluctuations on rate accuracy depends on thehalf-life of the drug being infused and on thedegree of intravascular integration, the clinicaleffect cannot be determined from the trumpet

curves alone. Knowledge of the start-upcharacteristics should also be considered.

The start-up curves represent continuous flowrate versus operating time for two hours fromthe start of the infusion. They exhibit the delayin onset of delivery due to mechanicalcompliance and provide a visual representationof uniformity. Trumpet curves are derived fromthe second hour of this data.

Under conditions of -100 mmHg, +100 mmHg,and +300 mmHg pressures, the Medley™ PCAModule typically exhibits a long-term accuracyoffset of approximately 0.2% or less from themean value.

NOTE: Tests conducted in accordance withIEC/EN 60601–2–24, “Particular requirements forsafety of infusion pumps and controllers” andAAMI ID26–1998 “Medical electrical equipment -Part 2: Particular requirements for the safety ofinfusion pumps and controllers”, using B-DPlastipak 60cc Syringe and ALARIS MedicalSystems® Administration Set (30910).

72 APPENDIX

Trumpet and Start-Up Curves (Continued)

Mode Start-up at 1 mL/h ( initial )

-0.2 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0

0 20 40 60 80 100 120

time ( min )

( mL

/ h )

Mode Trumpet Curve at 1 mL/h ( initial )

-3.6 -3.2

-1.4 -1.8

-4.1 -3.1 -5.3

-2.1 0.3

-0.7 -2.6

-17

-12

-7

-2

3

8

13

0 5 10 15 20 25 30 observation interval ( min )

flow

rate

err

or (%

)

Legend:Maximum rate errorOverall rate errorMinimum rate error

Mode Start -up at 5 mL/h ( initial )

-1 0 1 2 3 4 5 6 7 8 9

10

0 20 40 60 80 100 120

time ( min )

( mL

/ h )

Mode Trumpet Curve at 5 mL/h ( initial )

-2.2 -1.9

-0.9 -1.1

-2.8 -1.8

1.1 -1.3

-4.2

-0.3 -1.6

-15

-10

-5

0

5

10

15

0 5 10 15 20 25 30 observation interval ( min )

flow

rate

err

or (%

)

mode Start-up at 0.1 mL/h ( initial )

-0.02

0.00 0.02

0.04

0.06

0.08 0.10

0.12

0.14

0.16

0.18

0.20

0 20 40 60 80 100 120

time ( min )

( mL

/ h )

mode Trumpet Curve at 0.1 mL/h ( initial )

-11.4 -9.0

-0.3 -2.5

-28.8 -7.6 -17.5

4.8 19.8

-4.1 -5.6

-120

-70

-20

30

80

0 5 10 15 20 25 30

observation interval ( min )

flow

rate

err

or (%

)

ALARIS®, ALARIS Medical Systems®,Guardrails®, and Medley™ are trademarks and registered trademarks of ALARIS Medical Systems, Inc.All other trademarks belong to their respective owners.

Patents, Brevets, Breveté, Patente, Brevetti, Brevettato, , Ned. Octrooi, Sv.:US – 5,601,445; 5,713,856; 5,781,442; 5,800,387; 5,836,910; 5,941,846. AU – 693,662; 703,178; 703,203; 719,254; 728,366.AT – 0,225,158. BE – 0,225,158. CA – 1,258,212; 2,026,518. CH – +0,225,158. DE – P3686558.3. FR – 0,225,158. GB – 0,225,158.IT – 0,225,158. JP – 1,816,872. NL – 0,225,158. SE - 0,225,158. TW – NI–107963. Other Patents Pending.

10010720 ©2004 ALARIS Medical Systems, Inc. All Rights Reserved

ALARIS Medical Systems, Inc.10221 Wateridge CircleSan Diego, California 92121 U.S.A.

Mail:P.O. Box 85335San Diego, California 92186-5335 U.S.A.

Documents

Directions for Use - Med One Group › pdf › manuals › userManuals › Alari… · PCA Dose The PCA Dose enables a patient to self-administer a bolus infusion to be delivered