Alaris Medical Systems MEDLEY 8220 Manual

PUMP MODULE
8100 SERIES
ALARM
INFUSING
STANDBY
CHANNEL
SELECT
CHANNEL
OFF
RESTART
PAUSE
PUMP
Medley™
M
MEEDDIICCAATTIIOONNSSAAFFEETTYYSSYYSSTTEEMM
P
PUUMMPPMMOODDUULLEE
8
8110000SSeerriieess
DIRECTIONS FFOR UUSE

INTRODUCTION GETTING STARTED ALARMS, ERRORS,
MESSAGES
TABLE OF CONTENTS
INTRODUCTION
ABOUT THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
GETTING STARTED
WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Unpacking Pump Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
ATTACHING AND DETACHING CHANNELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Dynamic Pressure Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Selecting New Patient and Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Modifying Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
PREPARING INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Flo-Stop®Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Priming Primary Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Loading and Removing Primary Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Setting Up Primary Administration Set for Gravity Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
PRIMARY MODE - BASIC INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Starting Rate/Volume Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Starting Volume/Duration Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Restarting Infusion Following Infusion Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Changing Rate or VTBI During Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Stopping Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Selecting Pressure Mode - Pump / Selectable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Viewing and Clearing Volume Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
AutoRestart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
SECONDARY MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Changing Primary Infusion Parameter During Secondary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Stopping Secondary Infusion and Returning to Primary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
CHANGING PRIMARY SOLUTION CONTAINER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
CHANNEL LABELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Selecting Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Removing Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Powering Off Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
MAINTENANCE APPENDIX
TABLE OF CONTENTS i

ii TABLE OF CONTENTS
GETTING STARTED (Continued)
SETTING UP DRUG CALCULATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Drug Calculation Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Using Guardrails®Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Using Non-Library Drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
PROGRAMMING BOLUS DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Using Guardrails®Drug Library Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Using Non-Library Drug Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Stopping Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Restoring Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
ANESTHESIA MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Enabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Disabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
DELAY OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Delaying Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Scheduling a Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
MULTIDOSE MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Programming with Volume/Duration Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Programming with Volume/Duration Disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
REVIEWING SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
REVIEWING SOFTWARE VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
ALARMS, ERRORS, MESSAGES
DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
MAINTENANCE
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Shared Infusion Settings (Pump Module and Syringe Module) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Pump Module Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
APPENDIX
TRUMPET AND START-UP CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

GENERAL CONTACT INFORMATION
Customer Advocacy
For clinical and technical questions, feedback, and troubleshooting assistance.
Phone, toll-free, within the United States and Canada: [phone], Ext. 7812
E-Mail: [email protected]
Technical Support
For technical information related to maintenance procedures and service manual support.
For more detailed information, refer to the “Service Information” section of this document.
United States:
Phone:
[phone]
Toll-free: [phone], Ext. 6003
Canada:
Phone, Toll-free:
Eastern: [phone]
Western: [phone]

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INTRODUCTION
INTRODUCTION
INTRODUCTION 1
The Medley™ Medication Safety System is a modular infusion
and monitoring system intended for use in today’s growing
professional healthcare environment, for use in adult, pediatric
and neonatal care.
The Medley™ Medication Safety System consists of the
Programming Module (8000 Series), the Guardrails®Safety
Software, and up to four detachable modules (or “channels”),
which provide infusion or monitoring capabilities.
NOTE: The Medley™ Programming Module name will be changing
in the near future to Medley™ Point-of-Care Unit.
The Medley™ Pump Module (8100 Series) is intended for
facilities that utilize infusion pumps for the delivery of fluids,
medications, blood, and blood products using continuous or
intermittent delivery through clinically acceptable routes of
administration; such as, intravenous (IV), intra-arterial (IA),
subcutaneous, epidural, enteral, or irrigation of fluid spaces.
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 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 by the facility’s own multi-
disciplinary team using the Guardrails®Editor, the PC-based
authoring tool. A data set is then electronically transferred to
the Medley™ System by qualified personnel. The approved data
sets are maintained by the Guardrails®Editor for future updates
and reference.
Information about Guardrails®Alerts that occur during use is
stored within the Medley™ Programming Module, and can be
accessed using the Guardrails®Continuous Quality Improvement
(CQI) Event Tracker and Guardrails®CQI Event Reporter.
About the System

2INTRODUCTION
This document provides directions for use for the Medley™
Pump Module. Read all instructions, for both the Pump Module
and Programming Module, before using the Medley™ System.
The Medley™ Pump Module uses a wide variety of Medley™
System/ Gemini Administration Sets. The sets are designed for
use with the Pump Module as well as for gravity-flow, stand-
alone use. For specific administration set instructions, refer to
the directions for use provided with the set. For set priming and
loading instructions, refer to the “Start-Up” 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™ Programming Module Directions for Use for system features and definitions.
AutoRestart The AutoRestart feature is part of the Medley™ System’s advanced
Downstream Occlusion Detection system. If enabled, the AutoRestart feature
minimizes nuisance patient-side occlusion alarms caused by momentary
kinking of tubing, IV pushes, etc.
Bolus Dose The Bolus Dose mode allows a bolus infusion to be programmed using either
the Guardrails®Drug Library or the drug calculation feature. The bolus
infusion can be programmed with or without a continuous infusion following
the bolus.
Channel Labels The Channel Labels feature is available when the Profiles feature is enabled. It
provides a hospital-defined list of labels, displayed in the Channel Message
Display, and identifying the channel with the solution being infused, the
catheter location, or other helpful information.
Delay Options The Delay Options feature allows the system to be programmed to delay the
start of an infusion a) for up to 120 minutes or b) for a specific time up to
23 hours 59 minutes. A callback for a programmed delay can be scheduled to
give an alert Before an infusion is to be initiated, After an infusion is
completed, Before aand AAfter an infusion, or no alert (None).
Drug Calculation The Drug Calculation mode allows:
• entry of drug dose (Medley™ System calculates correct flow rate to achieve
desired dose),
OR
• entry of flow rate (Medley™ System calculates corresponding drug dose).
Dynamic Pressure Display The Dynamic Pressure Display appears on the Main Display. If enabled, it
graphically displays the current patient-side occlusion pressure set point and
the current patient-side operating pressure for that module. (Reference
“Displays” section in “Getting Started” chapter for additional “Dynamic
Pressure Display” information.)
Free Flow Protection All Medley™ System/Gemini administration sets utilize a unique clamping
device, the Flo-Stop®Device, to prevent inadvertent free flow when the
administration set is removed from the instrument.
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. A specific 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.
INTRODUCTION 3
INTRODUCTION
Features and Definitions

Guardrails®Limit A Guardrails®Limit is a programming limit or best-practice guideline
determined by the hospital/health system and entered into the system’s data
set. Profile-specific limits are defined for flow rate, patient weight, and
maximum and minimum continuous dose for each drug in a Guardrails®Drug
Library. 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.
KVO Rate Adjust The KVO Rate Adjust option is used to select the KVO (Keep Vein Open) rate
(0.1 to 20 mL/h allowed). This determines the rate of fluid flow after an
“Infusion Complete” occurs. The KVO rate will never exceed the infusion rate.
Multidose Mode The Multidose Mode option allows 2 - 24 doses to be programmed at equally
spaced intervals on the same Pump Module over a 24-hour period. This mode
is designed to allow delivery of multiple, equal doses from the same IV
container at regularly scheduled intervals.
Occlusion Pressure A complete range of downstream occlusion detection options is provided.
•Pump mode: Downstream occlusion alarm threshold is 525 mmHg at
flow rates of 30 mL/h or greater. For rates <30 mL/h, the occlusion
pressure is rate-dependent, to ensure rapid response to occlusions.
•Selectable pressure mode: Downstream occlusion alarm threshold can
be adjusted in 25 mmHg increments, up to the maximum occlusion
pressure of 525 mmHg.
•AutoRestart: (See “AutoRestart” definition.)
In addition, the Medley™ System provides fluid-side occlusion detection.
Restore To simplify programming, the Restore feature can be used to recall previous
rate and volume settings 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.
Secondary Infusions Dual rate sequential piggyback (Secondary) infusions may be infused at
delivery rates and volumes independent of the primary infusion parameters.
Automatic changeover occurs to the primary infusion parameters when the
secondary infusion is complete if a Medley™ System/Gemini Check Valve
Administration Set is used.
Volume/Duration The Volume/Duration infusion option allows a volume-to-be-infused (VTBI)
and duration (infusion time) to be programmed. The flow rate is
automatically calculated.
4INTRODUCTION
Features and Definitions (Continued)

INTRODUCTION 5
INTRODUCTION
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 2601-1 and IEC 60601–2–24).
Electrical Shock Protection Rating: Type CF, Defibrillation-proof
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 Programming Module and attached modules.
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.
Drops per milliliter specification for product will be identified on drop symbol.
Product incorporates SmartSite®Needle-Free Valve Ports and should not be accessed by a
needle.
Approximate administration set priming volume.
Expiration date for product will be identified near hour glass symbol.
Do not use if package is damaged.
LATEX
DEHP
Symbols
+75
IPX1
!
MM-YYYY
nly
O
XX ml
XX
2
Single-Use

6INTRODUCTION
THIS PAGE
INTENTIONALLY
LEFT BLANK

For WARNINGS and CAUTIONS for the Programming Module,
refer to its Directions for Use.
To ensure proper performance of the Medley™ System and to
reduce potential injury, observe the following precautions:
Epidural Administration
The Medley™ System 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 a Medley™
System/Gemini Series administration set, w
wiitthhoouutta ‘Y’
connector or injection port, for epidural infusions.
• Epidural administration of anesthetic drugs: Use
indwelling catheters specifically indicated for short-term
(96 hours or less) 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.
GETTING STARTED
GETTING STARTED 7
GETTING STARTED
NOTE: Although the Medley™ Medication Safety System is built
and tested to exacting specifications, it is not intended to replace
the supervision of IV infusions by medical personnel. The user
should become thoroughly familiar with the features and operation
of the Medley™ System and exercise vigilance in its utilization.
A warning is an alert to potential serious outcomes (death,
injury or serious adverse events) to the patient or user.
WARNING
A caution is an alert to take special care for the safe and
effective use of the device.
CAUTION
Warnings and Cautions
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
source container, Medley™ System/
Gemini Administration Set, and Pump
Module used for epidural drug
delivery be clearly differentiated from
those used for other types of
administration.
WARNING
nly
O
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

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
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
8GETTING STARTED
Use only Medley™ System/Gemini Series Administration Sets.
The use of any other set may cause improper instrument
operation, resulting in an inaccurate fluid delivery or other
potential hazard. For a list of compatible sets, refer to the Set
Compatibility Card (provided separately).
WARNING
This Medley™ Pump 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, filters and intra-arterial infusion. It is neither designed
nor intended to detect infiltrations and will not alarm under
infiltration conditions.
WARNING
Warnings and Cautions (Continued)
Hospital/facility personnel must ensure the compatibility of the
drugs as well as the performance of each module as part of the
overall infusion. Potential hazards include drug interactions,
inaccurate delivery rates, inaccurate pressure alarms and
nuisance alarms.
WARNING
Do not use the Medley™ System in close proximity of Magnetic
Resonance Imaging (MRI).
WARNING

GETTING STARTED 9
GETTING STARTED
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/facility personnel must
ensure the performance of the common IV site is satisfactory
under these circumstances.
WARNING
Warnings and Cautions (Continued)
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
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.
User Precautions
To ensure proper performance of the Medley™ System and to
reduce potential injury to the operator, observe the following
precautions:
• Disconnect from main (AC) power when performing
maintenance.
• The instrument case should only be opened by qualified
service personnel using proper grounding techniques.
To prevent a potential free-flow condition, ensure no extraneous
object (for example, bedding, tubing, glove) is enclosed or
caught in the Medley™ Pump Module door.
WARNING

Administration Sets
• For a list of compatible administration sets, refer to Set
Compatibility Card (provided separately).
• For specific administration set instructions, refer to
directions for use provided with set. For set 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.
• Pump Module administration sets 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.
SmartSite®Needle-Free System:
• SmartSite®Needle-Free Valve Port is contraindicated for blunt
cannula systems.
• Swab top of SmartSite®Needle-Free Valve Port with preferred
antiseptic prior to each access.
NOTES:
• If applicable, attach syringe to SmartSite®Needle-Free Valve Port
and aspirate minute air bubbles.
• In an emergency, SmartSite®Valve may be accessed by a needle
and will leak if punctured. To access port with needle without
causing leakage, attach a “PRN” adapter of sufficient length to
SmartSite®Needle-Free Valve Port.
10 GETTING STARTED
Warnings and Cautions (Continued)
User Precautions (Continued)
Use only Medley™ System/Gemini
Series administration sets. The use of
any other set may cause improper
instrument operation, resulting in an
inaccurate fluid delivery or other
potential hazard.
WARNING

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.
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.
GETTING STARTED 11
GETTING STARTED
User Precautions (Continued)
Warnings and Cautions (Continued)
Explosion risk if used in the presence
of flammable anesthetics.
DANGER

12 GETTING STARTED
Radio Frequency Interference
Operating the system near equipment which radiates high-
energy radio frequencies (electrosurgical/cauterizing
equipment, portable radios, cellular telephones, etc.) may
cause false alarm conditions. If this happens, reposition the
device away from the source of interference or turn off the
device and manually regulate the flow with the clamp and/or
monitor the vital parameters using an appropriate clinical
alternative.
Warnings and Cautions (Continued)
User Precautions (Continued)
Use of accessories or cables other
than those specified may result in
degraded electromagnetic
compatibility performance of this
device.
WARNING

GETTING STARTED 13
GETTING STARTED
INFUSE
STANDBY
ALARM
CHANNEL
SELECT
CHANNEL
OFF
PAUSE
RESTART
Controls and Indicators
Front/Side View - Door Closed
Infusing
(green)
Alarm
(red)
IUI Connector, Left
Standby
(yellow)
Rate Display
Channel Message Display
Channel Identification
Channel Release Latch
Door Handle
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
≈2 minutes, “PRESS START” visual
and audio prompt begins.)
Channel Off Key - When pressed
and held until a beep is heard, 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.
Status Indicators IUI Connector, Right
(not visible)

14 GETTING STARTED
Controls and Indicators (Continued)
Front View - Door Open
Platen
Upper Tubing
Fitment Retainer
IUI Connector, Right
Door Latch Cam/Slide
Tubing Keeper
Upper Pressure Sensor
Lower Pressure Sensor
Flo-Stop®Recess
Air-in-Line Sensor
Upper Occluder
Lower Occluder
Upper Pumping Finger
Lower Pumping Finger
IUI Connector, Left
(not visible)