Alaris Medical Systems Medley 8110 Manual

SYRINGE MODULE
MODEL 8110
A
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IN
FU
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CHANNEL
SELECT
CHANNEL
OFF
PAUSE
RESTART
RATE (mL/h)
Syringe Module
Syringe Module, Model 8110
Directions for Use
Medication Safety System
Medle
y
™

INTRODUCTION GETTING STARTED ALARMS, ERRORS,
MESSAGES
TABLE OOFCCONTENTS
INTRODUCTION
ABOUT THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
GETTING STARTED
WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Unpacking Syringe Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
ATTACHING AND DETACHING CHANNELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Dynamic Pressure Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Selecting New Patient and Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Modifying Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
PREPARING INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Preparing Syringe and Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Loading Syringe and Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Selecting Syringe Type and Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
BASIC INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Starting Rate / Volume Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Starting Volume / Duration Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Possible End of Infusion Messages and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Restarting Infusion Following Infusion Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Changing Rate or VTBI During Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Stopping Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Selecting Pressure Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Viewing and Clearing Volume Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Changing Syringe During Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
CHANNEL LABELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Selecting Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Removing Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Powering Off Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
SETTING UP DRUG CALCULATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Drug Calculation Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Using Guardrails®Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Using Non-Library Drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
MAINTENANCE APPENDIX
TABLE OF CONTENTS i

ii TABLE OF CONTENTS
GETTING STARTED (Continued)
PROGRAMMING BOLUS DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Using Guardrails®Drug Library Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Using Non-Library Drug Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Stopping Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Restoring Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
ANESTHESIA MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Enabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Disabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
DELAY OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Delaying Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Scheduling a Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
MULTIDOSE MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Programming with Volume/Duration Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Programming with Volume/Duration Disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
REVIEWING SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
REVIEWING SOFTWARE VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
ALARMS, ERRORS, MESSAGES
DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Syringe Adjustment Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
MAINTENANCE
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Shared Infusion Settings (Pump Module and Syringe Module) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Syringe Module Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
COMPATIBLE SYRINGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
APPENDIX
TRUMPET AND START-UP CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

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.
GENERAL CONTACT INFORMATION
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™ Syringe Module (Model 8110) 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™
Syringe Module. Read all instructions, for both the Syringe
Module and Programming Module, before using the Medley™
System.
The Medley™ Syringe Module uses standard, single-use,
disposable syringes (with luer-lock connectors) and
administration sets, designed for use on syringe pumps. 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™ Programming Module Directions for Use for system features and definitions.
ALL Mode When ALL is selected as the volume to be infused (VTBI), the
entire contents of the syringe will be delivered.
Auto Pressure When enabled and a pressure sensing disc is in use, the Auto
Pressure option is displayed in the Pressure Limit screen. Auto
Pressure automatically sets the alarm limit for a shorter time to
alarm, as follows:
• If current pressure is 100 mmHg or less, system adds
30 mmHg to current pressure, to create a new alarm limit.
• If current pressure is greater than 100 mmHg, system adds
30% to current pressure, to create a new alarm limit.
Auto Pressure Limit Adjustment When a bolus is delivered, the pressure alarm limits are
temporarily raised to the maximum limit.
Auto Syringe Size Identification The system automatically detects the syringe size and narrows
down the syringe selection list.
Back Off This feature is only available when the administration set in use
has a pressure sensing disc. When enabled, the motor reverses
plunger movement during an occlusion until the pressure
returns to preocclusion levels, automatically reducing bolus flow.
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 B
Beeffoorreean
infusion is to be initiated, A
Afftteerran infusion is completed, BBeeffoorree
a
annddAAfftteerran infusion, or no alert (NNoonnee).
INTRODUCTION 3
INTRODUCTION
Features and Definitions

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.)
Event Logging Event Logging records instrument operations.
Fast Start When Fast Start is enabled and an administration set having a
pressure sensing disc is used, the instrument runs at an
increased rate when an infusion is first started, taking-up any
slack in the drive mechanism.
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.
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.
4INTRODUCTION
Features and Definitions (Continued)

Multidose Mode The Multidose Mode option allows 2- 24 doses to be
programmed at equally spaced intervals on the same Syringe
Module over a 24-hour period. This mode is designed to allow
delivery of multiple, equal doses from the same syringe at
regularly scheduled intervals.
Near End of Infusion (NEOI) The NEOI option allows an alert to be configured to sound
anywhere from 1to 60 minutes before the infusion is complete.
The alert will occur at the configured time or when 25% of the
VTBI remains, whichever comes later.
Occlusion Pressure A complete range of downstream occlusion detection options is
provided.
•With pressure sensing disc: Downstream occlusion alarm
threshold is selectable between 25 and 1000 mmHg, in
1mmHg increments.
•Without pressure sensing disc: Downstream occlusion
alarm threshold can be set to low, medium, or high.
Pressure Sensing Disc When installed, the pressure sensing disc significantly improves
the instrument’s pressure sensing capabilities for a faster
occlusion detection time, and makes the following features
available:
Auto Pressure
Back-Off
Customizable Pressure Alarm Settings (see “Occlusion Pressure”)
Fast Start
Pressure Tracking
Pressure Tracking The dynamic current pressure display is only available when the
pressure sensing disc is inserted.
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 2mL of priming fluid.
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 8hours of last usage.
INTRODUCTION 5
INTRODUCTION
Features and Definitions (Continued)

Selectable KVO The Selectable KVO option allows some infusions to
automatically switch into KVO mode upon completion. The KVO
option setting cannot be changed after the instrument is
powered on and a profile selected.
Syringe Empty The instrument gives an alert and stops when an empty syringe
is detected.
Syringe Volume Detection The system automatically detects the fluid volume in a syringe
when it is inserted.
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.
6INTRODUCTION
Features and Definitions (Continued)

INTRODUCTION 7
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.
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
2
Single-Use

8INTRODUCTION
THIS PAGE
INTENTIONALLY
LEFT BLANK

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 9
GETTING STARTED
GETTING SSTARTED
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
nly
O
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 standard,
single-use, disposable syringes (with luer-lock connectors)
and administration sets, designed for use on syringe pumps
and 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.
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
Syringe Module used for epidural
drug delivery be clearly differentiated
from those used for other types of
administration.
WARNING

10 GETTING STARTED
Warnings and Cautions (Continued)
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
The Medley™ Syringe 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
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/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

Use only standard, single-use, disposable syringes (with luer-lock
connectors) and administration sets, designed for use on syringe
pumps. The use of any other syringe or administration set may
cause improper instrument operation, resulting in inaccurate
fluid delivery or pressure sensing, or other potential hazards. 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).
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
GETTING STARTED 11
GETTING STARTED
Warnings and Cautions (Continued)
When the pressure sensing disc is not being used and 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
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™ Syringe Module. Mismatches may cause an under-
infusion 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

12 GETTING STARTED
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.
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
Each time the Medley™ System is turned on, verify and/or set
the monitoring mode, resistance alert, and/or pressure alarm
limit. If the monitoring mode, resistance alert, and/or pressure
alarm limit are not verified, the instrument may not operate
within the desired occlusion detection parameter(s).
WARNING
Installing a pressure sensing disc after an infusion has started
can result in a bolus to the patient.
WARNING

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.
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).
• 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.
• Syringe 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.
GETTING STARTED 13
GETTING STARTED
Warnings and Cautions (Continued)
User Precautions
Use only standard, single-use,
disposable syringes (with luer-lock
connectors) and administration sets,
designed for use on syringe pumps.
The use of any other syringe or
administration set may cause
improper instrument operation,
resulting in inaccurate fluid delivery
or pressure sensing, or other
potential hazards. 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).
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.
Electromagnetic Compatibility (EMC)
When using the Syringe Module in combination with a
Programming Module 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 950 (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).
14 GETTING STARTED
Warnings and Cautions (Continued)
User Precautions (Continued)