ALARIS Medical Systems Medley 8120 User Guide

Directions for Use

Patient Controlled Analgesia (PCA) Module, 8120 Series

ALARIS Medical Systems, Inc.

™

Medley

Medication Safety System

PCA MODULE

MODEL 8120

THIS PAGE

INTENTIONALLY

LEFT BLANK

INTRODUCTION

GETTING STARTED

ALARMS, ERRORS,

MESSAGES

TABLE OF CONTENTS

INTRODUCTION

ABOUT THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

FEATURES AND DEFINITIONS

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SYMBOLS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

GETTING STARTED

WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

CONTROLS AND INDICATORS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

INSTALLATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Unpacking PCAModule

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

ATTACHING AND DETACHING MODULES

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

DISPLAYS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Main Display

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

PREPARING SYRINGE AND ADMINISTRA TION SET

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

ATTACHING AND DETACHING DOSE REQUEST CORD

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

START-UP

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Powering On System

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Responding to Maintenance Reminder

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Choosing YES or NO to New Patient? and Profile?

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Selecting Profile

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Entering Patient ID

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

PREPARING INFUSION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Loading Syringe and Administration Set

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Security Lock Key Positions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Selecting Syringe Type and Size

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Priming

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Programming an Infusion

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

PCA INFUSION MODES

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

PCA Module Programming Parameters

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Setting Up PCA Dose Only

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Setting Up Continuous Infusion Only

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Setting Up PCA Dose + Continuous Infusion

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Setting Loading Dose Only

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Setting Bolus Dose

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Stopping a Loading, PCAor Bolus Dose

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Changing Programming Parameters During an Infusion

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Viewing Patient History

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Clearing Patient History

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Viewing Drug Event History

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Configuring Dose Request Cord

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Security Access Levels

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Pausing Infusion

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Restoring Infusion Following Syringe Empty

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Stopping Infusion

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Selecting Pressure Limit

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Viewing and Clearing Volume Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Changing Syringe During Infusion

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POWERING OFF

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Powering Off Channel

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Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

MAINTENANCE APPENDIX

TABLE OF CONTENTS i

ALARMS, ERRORS, MESSAGES

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

AUDIO CHARACTERISTICS

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ALARMS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Syringe Adjustment Alarms

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ERRORS

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MESSAGES

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MAINTENANCE

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

CONFIGURABLE SETTINGS

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System Settings

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PCA Module Settings

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COMPATIBLE SYRINGES

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COMPATIBLE SETS

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CLEANING

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INSPECTION REQUIREMENTS

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SERVICE INFORMATION

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APPENDIX

TRUMPETAND START-UP CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

ii TABLE OF CONTENTS

GENERAL CONTACT INFORMATION

Customer Care - North America

Instrument return, service assistance, and order placement.

United States:

Phone:

[phone]

Canada:

Phone:

[phone]

Customer Advocacy - North America

Clinical and technical feedback.

Phone: [phone], Ext. 7812

E-Mail: [e-mail]

Technical Support - North America

Maintenance and service information support; troubleshooting.

United States:

Phone:

[phone]
[phone], Ext. 6003

Canada:

Phone:

Eastern: [phone]
Western: [phone]

THIS PAGE

INTENTIONALLY

LEFT BLANK

The Medley™Medication Safety System is a modular infusion
and monitoring system intended for use in today’s growing
professional healthcare environment, for use in adult, pediatric
and neonatal care. The Medley

™

Medication Safety System
consists of the Point-of-Care Unit (PCU) (8000 Series), the
Guardrails

®

Safety Software, and up to four detachable

modules which provide infusion or monitoring capabilities.
The Medley

™

PCU controls the Medley™System and provides
a common user interface for programming and monitoring an
infusion, 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 syringe
pumps for the delivery of medications or fluids using
continuous or intermittent delivery through clinically
acceptable routes of administration; such as, intravenous (IV),
subcutaneous or epidural.

The Guardrails

®

Safety Software for the Medley™System
brings a new level of medication error prevention to the point
of patient care. The Guardrails

®

Safety Software features
hospital-defined medication dosing guidelines for up to ten
patient-specific care areas, referred to as profiles. Each
profile contains a specific drug library and channel labels, as
well as instrument configurations appropriate for the care
area. Optional drug-specific Guardrails

®

Clinical Advisories
provide visual messages. Dosing limits for each drug entry
may be either Guardrails

®

Hard Limits that cannot be

overridden during infusion programming, or Guardrails

®

Soft

Limits that can be overridden, based on clinical requirements.
A data set is developed and approved through the facility’s

own multi-disciplinary team using the Guardrails

®

Editor, the
PC–based authoring tool. Adata set is then transferred to the
Medley™System by qualified personnel. The approved data
sets are maintained by the Guardrails

®

Editor for future
updates and reference. Adata set is required prior to using
the Medley

™

PCA Module.

Information about Guardrails

®

Alerts that occur during use are

stored within the Medley

™

PCU, and can be accessed using

the Guardrails®Continuous Quality Improvement (

CQI) Event

Tracker and Guardrails

®

CQI Reporter.

INTRODUCTION

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™PCA
Module and the Medley

™

PCU before using the Medley

™

System.
The Medley

™

PCA Module uses non-dedicated standard or
pre-filled, single-use, disposable syringes (with luer-lock
connectors) and administration sets with anti-siphon valves,
designed for use on syringe-type PCA devices. For specific
administration set instructions, refer to the directions for use
provided with the set. For set priming and loading
instructions, 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 various
alerts. 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 are

temporarily raised to the maximum limit.

Auto Syringe Identification The system automatically detects the syringe size and

narrows down the syringe selection list.

Bolus Dose The Bolus Dose feature enables a clinician to program an

additional amount of medication once the PCA infusion has
begun. The current PCAinfusion will resume following the
delivery 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 to
programmed PCA parameters. The dose request cord
features an indicator light which can be configured to provide
feedback to the patient on requested PCAdoses. The dose
request cord is enabled in PCA only and PCA + Continuous
modes.

Drug Event History Records and displays sequential device events for a typical 12

hours, 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 that

appears when a designated drug is selected, to remind a

clinician of specific hospital standards of practice when

programming an IV medication. Aspecific clinical advisory

can be associated with a selected drug within any of the

patient care profiles.
Guardrails

®

Drug Library The Guardrails®Drug Library feature is a drug calculation

mode available when the Profiles feature is enabled. It

provides a hospital-defined list of drugs and concentrations

appropriate for use in as many as 10 profiles. Using the Drug

Library automates programming steps, including the drug

name, drug amount and diluent volume, and activates the

hospital-established best-practice Guardrails

®

Limits. A

Guardrails

®

Safety Software data set is required prior to using

the Medley

™

PCA Module.

INTRODUCTION 3

INTRODUCTION

Features and Definitions

4 INTRODUCTION

Features and Definitions (Continued)

Guardrails®Limit A Guardrails®Limit is a programming limit or best-practice

guideline for programming a dose limit parameter or

instrument configuration determined by the hospital/health

system and entered into the system’s data set. Dose limits

can be defined by the hospital/health system as either “hard”

or “soft” limits.

• A Guardrails

®

Hard Limit is a programmed limit that cannot

be overridden.

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

Loading Dose The Loading Dose enables a clinician to program a bolus

infusion prior to initiation of the PCA infusion. The Loading
Dose may be programmed from the Infusion Modes menu or
applicable PCA, PCA + Continuous or Continuous Only
programming screen prior to the start of a new PCAinfusion
program.

Lockout Interval Allows the clinician to program a pre-determined interval of

time that must elapse between delivery of PCAdoses.

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 are
completed using the Guardrails

®

Drug Library.

Near End of Infusion (NEOI) The NEOI option allows an alert to be configured to sound

anywhere between 5 - 25% volume remaining.

INTRODUCTION 5

Features and Definitions (Continued)

INTRODUCTION

Patient History The PCA Module records and displays patient history for up to

24 hours, and may be trended to the following intervals:
1hr/2hr/4hr/8hr/12hr/24hr. Patient history includes the
following 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 bolus

infusion to be delivered at programmed lockout intervals
through the dose request cord. When programmed in the
PCA+Continuous mode, the continuous infusion will resume
following the PCA dose.

Priming The Priming option allows a limited volume of fluid to be

delivered in order to prime the administration set prior to being
connected to a patient or after changing a syringe. When
priming, a single continuous press of the

PRIME soft key

delivers up to 2 mL of priming/fluid.

Restore To simplify programming, the Restore feature can be used to

recall previous PCA programming parameters for the same
patient. This option is only available if the patient is not new
and the system is powered up within

8 hours of last usage.

Syringe Empty The instrument gives an alert and stops when an empty

syringe is detected.

Syringe Volume Detection The system automatically detects the fluid volume in a syringe

when it is inserted.

6 INTRODUCTION

Symbols

Canadian and U.S. Certification Mark: Products bearing this mark have been tested
and certified in accordance with applicable

U.S. and Canadian electrical safety and

performance 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 and

communications between the Point-of-Care Unit and attached channels.
Manufacturing Date: Number adjacent to symbol indicates the month and year of

manufacture.

Consult operating instructions.

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

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 is

latex-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.

IPX1

!

MM-YYYY

+

75

nly

O

Single-Use

2

» XX ml

xx

µm

DEHP

NOTE: Although the Medley™Medication Safety System is built
and tested to exacting specifications, it is not intended to replace
the supervision of

IV infusions by medical personnel. The user

should become thoroughly familiar with the features and
operation of the Medley

™

System and exercise vigilance in its

utilization.

GETTING STARTED

GETTING STARTED 7

GETTING STARTED

Warnings and Cautions

nly

O

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

WARNING

Do not use the Medley™System in close proximity of Magnetic
Resonance Imaging (

MRI).

WARNING

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

A is an alert to take special care for the safe
and 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 Unit

Directions for Use.

CAUTION

WARNING

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

WARNING

The Guardrails®Safety Software incorporates dosing limits
and instrument configuration parameters based on hospital
protocol. The software adds a test of reasonableness to drug
programming based on the limits defined by the hospital.
Qualified personnel must ensure the appropriateness of the
drug dosing limits, the compatibility of the drugs, and the
performance of each instrument, as part of the overall
infusion. Potential hazards include drug interactions, and
inappropriate delivery rates and pressure alarms.

WARNING

8 GETTING STARTED

Warnings and Cautions (Continued)

The Medley™ PCA Module is a positive displacement delivery
system, capable of developing positive fluid pressures to
overcome widely varying resistances to flow encountered in
practice, including resistances to flow imposed by small gauge
catheters and filters. It is neither designed nor intended to
detect infiltrations and will not alarm under infiltration
conditions.

WARNING

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

WARNING

Hospital personnel must ensure the compatibility of the drugs
as well as the performance of each channel as part of the
overall infusion. Potential hazards include drug interactions,
inaccurate delivery rates, inaccurate pressure alarms and
nuisance alarms.

WARNING

Use only standard or pre-filled, single-use, disposable
syringes (with luer-lock connectors) and non-dedicated
administration sets with anti-siphon valves, designed for use
on syringe-type PCA devices. The use of any other syringe or
administration set may cause improper instrument operation,
resulting in inaccurate fluid delivery, or other potential
hazards. 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 Set
Compatibility Card (provided separately and in this Directions
for Use).

WARNING

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

WARNING

When an occlusion occurs, there is a risk of infusing
pressurized buildup of infusates upon correction of the
occlusion. To avoid an inadvertent bolus, relieve the pressure
before restarting the infusion.

WARNING

GETTING STARTED 9

Warnings and Cautions (Continued)

GETTING STARTED

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 and
cause the total volume to be infused to read higher than the
actual total delivered to the patient.

WARNING

Ensure the syringe manufacturer and syringe size displayed
matches the syringe manufacturer and syringe size installed in
the Medley™ PCA Module. Mismatches may cause an under­infusion or over-infusion to the patient that could result in
serious 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 doses
are for illustration purposes only. Refer to specific drug
product labeling for information concerning appropriate
administration techniques and dosages.

WARNING

The use of positive displacement infusion devices ported
together with gravity flow infusion systems into a common

IV

site may impede the flow of common “gravity only” systems,
affecting their performance. Hospital personnel must ensure
the performance of the common

IV site is satisfactory under

these circumstances.

WARNING

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

WARNING

10 GETTING STARTED

Warnings and Cautions (Continued)

Parallel Infusions

There are no contraindications regarding the use of the
Medley™ System with any other positive displacement
infusion device when ported together into a common IV site
location.

When the Medley™ PCA Module is used with a primary IV
line, use of an appropriate Y-set with a backcheck valve is
highly recommended. Failure to properly use a Y-set may
result in retrograde analgesic flow into the primary line during
a partial or complete downstream occlusion. This may
subsequently result in an inadvertent bolus to the patient
when the occlusion is cleared.

WARNING

User Precautions

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

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

• Refer to analgesic package enclosure for possible
incompatibility with fluid or drug being delivered through the
maintenance line.

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

• Disconnect from main (

AC) power when performing

maintenance.

• Do not open the instrument case. The case should only be
opened by qualified service personnel using proper
grounding techniques.

GETTING STARTED 11

Warnings and Cautions (Continued)

User Precautions (Continued)

Epidural Administration

The Medley™ PCA Module can be used for epidural
administration of anesthetic and analgesic drugs. This
application is only appropriate when using analgesics and
anesthetics labeled for continuous epidural administration and
catheters intended specifically for epidural use. Use only
standard, single-use, disposable syringes (with luer-lock
connectors) and administration sets, designed for use on
syringe pumps and without a ‘Y’ connector or injection port,
for epidural infusions.

• Epidural administration of anesthetic drugs: Use indwelling

catheters specifically indicated for short-term anesthetic
epidural drug delivery.

• Epidural administration of analgesic drugs: Use indwelling

catheters specifically indicated for either short-term or
long-term analgesic epidural drug delivery.

Epidural administration of drugs other
than those indicated for epidural use
could result in serious injury to the
patient.

WARNING

It is strongly recommended that the
syringe, administration set, and the
Medley™ PCA Module used for
epidural drug delivery be clearly
differentiated from those used for
other types of administration.

WARNING

Administration Sets and Syringes

• For a list of compatible syringes, refer to “Compatible

Syringes” section in “Maintenance” chapter.

• For a list of compatible administration sets, refer to Set

Compatibility Card (provided separately and in this
Directions for Use).

• For specific administration set instructions, refer to

Directions For Use provided with set. For set priming and
loading instructions, refer to “Preparing Infusion” section of
this document.

• Before operating instrument, verify that administration set

is free from kinks and installed correctly in instrument.

• The administration sets compatible with the Medley™ PCA

Module are supplied with a sterile fluid path for one-time
use. 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, CDC
guidelines in the United States).

• For IV push medication, put instrument on hold, clamp

tubing above the port.

• Flush port(s) per facility protocol.

• Discard administration set per facility protocol.

Use only standard or pre-filled, single­use, disposable syringes (with luer­lock connectors) and non-dedicated
administration sets with anti-siphon
valves, designed for use on syringe­type PCA devices. The use of
incompatible syringe or administration
set may cause improper instrument
operation, resulting in inaccurate fluid
delivery, or other potential hazards.
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 Set Compatibility Card
(provided separately and in this
Directions for Use).

WARNING

Dose Request Cord Use

• Only the patient should press the dose request cord

button.

GETTING STARTED

12 GETTING STARTED

Warnings and Cautions (Continued)

User Precautions (Continued)

Artifacts

It is normal for an infusion device to produce nonhazardous
currents when infusing electrolytes. These currents vary
proportional to the infusion device flow rate. When the ECG
monitoring system is not functioning under optimal conditions,
these currents may appear as artifacts, simulating actual ECG
readings. To determine if ECG abnormalities are caused by
patient condition or the ECG equipment, place the infusion
device on hold. If the ECG readings become normal, the
ECG equipment requires attention. Proper setup of the ECG
equipment should eliminate these artifacts. Reference the
appropriate ECG monitoring system documentation for
instructions on setup and maintenance.

Radio Frequency Interference

Operating the system near equipment which radiates high­energy radio frequencies (electrosurgical/cauterizing
equipment, portable radios, cellular telephones, etc.) may
cause false alarm conditions. If this happens, reposition the
infusion device away from the source of interference or turn
off the infusion device and manually regulate the flow with the
clamp and/or monitor the vital parameters using an
appropriate clinical alternative.

Electromagnetic Compatibility (EMC)

When using the Medley™ PCA Module in combination with
a Medley™ Point-of-Care Unit which is interconnected to
hospital data communications equipment and/or nurse call
systems (signal input and signal output ports), the external
systems must be certified to applicable standards to ensure
correct operation and electromagnetic compliance integrity

Interconnected data communications systems must be
certified to

IEC 60950 (data processing equipment) or

IEC 60601–1 electromedical equipment. Nurse call systems

must be certified to

UL 1069 (hospital signaling and nurse

call equipment) or comply with the requirements specified
in IEC 60601–1.

Compliance with the electromagnetic compatibility standard
(

IEC 60601-1-2) is a function of all interconnected

equipment including cabling and, as such, it is the
responsibility of the hospital/facility to ensure external
equipment complies with the applicable

EMC standards.

Failure to verify that external equipment meets applicable

EMC

standards may result in degraded electromagnetic
compatibility (refer to “Radio Frequency Interference”
warning for additional information)

Use of accessories or cables other
than those specified may result in
degraded electromagnetic
compatibility performance of this
device.

WARNING

GETTING STARTED 13

Warnings and Cautions (Continued)

User Precautions (Continued)

Dropping/Jarring

Should an instrument be dropped or severely jarred, it
should be immediately taken out of use and inspected by
qualified service personnel, to ensure its proper function
prior to reuse.

Operating Environment

Not for use in the presence of flammable anesthetics.

Explosion risk if used in the
presence of flammable anesthetics.

DANGER

GETTING STARTED

14 GETTING STARTED

Controls and Indicators

Rate Display

Channel Message Display
Channel Identification

Channel Release Lever

Channel Select Key -

When
pressed, selects corresponding
channel for infusion parameter
entry and infusion setup.

Pause Key - When pressed during an

infusion, temporarily stops infusion on
that channel. After approximately
2 minutes, a visual and audio prompt
begins.

Channel Off Key - When pressed and

held for one second and then released,
stops infusion on that channel, deselects
that channel, and if only that channel
had been operating, system powers
down. Repeat for other operating
channels to power off each channel.

Restart Key - When pressed, resumes

operation of a previously paused or
alarmed infusion on that channel.

Infusing

(green)

Alarm

(red)

Standby

(yellow)

Status Indicators

IUI Connector, Left

Gripper Control /
Drive Head
Release (shown

in closed position

)

Plunger
Grippers (shown

in closed position

)

Syringe Barrel
Clamp / Sizer

Syringe Barrel
Sensor

Dose Request Cord
Attachment

Security Lock

Security Door

Dose Request Cord

GETTING STARTED 15

GETTING STARTED

Installation

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

2. Verify gripper control/drive head release, plunger

grippers, and syringe barrel clamp/sizer operate freely
and correctly.

3. Verify control surface and instrument housing is not

damaged.

4. Check for loose parts.

5. Perform Periodic Inspections (see “Inspection

Requirements” section in “Maintenance” chapter).

6. Perform check-in procedure (provided separately; contact

ALARIS Medical Systems for further information). If the

Medley™ PCA Module fails initial test, it must be removed
from service and inspected by qualified personnel.

If the Medley™ PCA Module is damaged, contact

ALARIS

Medical Systems for authorization to return the instrument for
repair.

Instruments are tested and calibrated before they are
packaged for shipment. To ensure proper operation after
shipment, it is recommended that an incoming inspection be
performed before placing the instrument into use.

Unpacking 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 for
illustration 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 Letter

display indicates channel is
attached and ready for use.

• A solid Channel Letter display

indicates channel is operating.

Soft Keys

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

Channel Selected Indicator
“Active” Soft Key

Highlighted indicates a selected
soft key.

“Inactive” Soft Key

Nonhighlighted indicates a
nonselected soft key.

Prompt Bar

Look here for user prompts.

1. Prepare syringe (reference “Compatible Syringes” section

in “Maintenance” chapter) in accordance with
manufacturer’s directions for use.

2. Prepare administration set (reference Set Compatibility

Card, 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, single­use, disposable syringes (with luer­lock connectors) and non-dedicated
administration sets with anti-siphon
valves, designed for use on syringe­type PCA devices. The use of
incompatible syringe or administration
set may cause improper instrument
operation, resulting in inaccurate fluid
delivery, or other potential hazards.
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 Set Compatibility Card
(provided separately and in this
Directions for Use).

WARNING

NOTE: Use Aseptic Technique.

Midtown Hospital
Med Surg

A

VTBI = ALL (30 mL)

B

VOLUME
INFUSED

Guardrails Drug Library

A

Fentanyl

DRUG

AMOUNT

DILUENT
VOLUME

TIME
UNITS

DOSING
UNITS

[Conc]:

>Select DILUENT VOLUME

AUDIO

ADJUST

_ _30 mcg
____mL

Hour

mcg

DRUG

LIBRARY

SYSTEM
ON

SYSTEM
ON

GETTING STARTED 17

GETTING STARTED

Attaching and Detaching Dose Request Cord

The Dose Request Cord must be attached to the PCAModule
when delivering a PCA Dose or PCA + Continuous Dose
infusion.

To attach the Dose Request Cord:

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

To detach the Dose Request Cord:

• Hold the body of latching connector and pull straight
away, without twisting or turning, from the Dose Request
Cord attachment.

Red alignment
marks

Latching Connector

Dose Request
Cord Attachment

Entering Patient ID

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

Start-Up

Responding to Maintenance Reminder

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

Powering On System

Choosing Yes or No to New Patient? and Profile?

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

Selecting Profile

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

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

18 GETTING STARTED