Alaris Medical Systems Medley 8100 Series Manual

PUMP MODULE
8100 SERIES
ALARM
INFUSING
STANDBY
CHANNEL
SELECT
CHANNEL
OFF
RESTART
PAUSE
PUMP
Directions for Use
Pump Module, 8100 Series
ALARIS Medical Systems, Inc.
Medley™Medication Safety System

GENERAL CONTACT INFORMATION
Customer Advocacy - North America
Clinical and technical feedback.
Phone: [phone], Ext. 7812
E-Mail: [email protected]
Technical Support - North America
Maintenance and service information support; troubleshooting.
United States:
Phone:
[phone]
[phone], Ext. 6003
Canada:
Phone:
Eastern: [phone]
Western: [phone]
Customer Care - North America
Instrument return, service assistance, and order placement.
United States:
Phone:
[phone]
Canada:
Phone:
[phone]

TABLE OF CONTENTS
INTRODUCTION
ABOUT THE PUMP MODULE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
GETTING STARTED
WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Guardrails®Safety Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Epidural Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
OPERATING FEATURES, CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
ATTACHING AND DETACHING MODULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Dynamic Pressure Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Selecting New Patient and Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Modifying Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
PREPARING INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Flo-Stop®Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Priming Primary Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Loading and Removing Primary Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Setting Up Primary Administration Set for Gravity Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
PROGRAMMING
PRIMARY MODE - BASIC INFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Starting Rate/Volume Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Starting Volume/Duration Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Restarting Infusion Following Infusion Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Changing Rate or VTBI During Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Stopping Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Selecting Pressure Mode - Pump / Selectable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Viewing and Clearing Volume Infused . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Auto-Restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
SECONDARY MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Changing Primary Infusion Parameter During Secondary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Stopping Secondary Infusion and Returning to Primary Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
CHANGING PRIMARY SOLUTION CONTAINER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
CHANNEL LABELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Selecting Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Removing Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Powering Off Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
TABLE OF CONTENTS i
Pump Module, 8100 Series
Directions for Use

PROGRAMMING (Continued)
SETTING UP DRUG CALCULATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Drug Calculation Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Using Guardrails®Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Using Non-Library Drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
BOLUS DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Using Guardrails®Drug Library Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Using Non-Library Drug Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Stopping Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Restoring Bolus Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
ANESTHESIA MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Enabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Disabling Anesthesia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
DELAY OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Delaying Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Scheduling a Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Pausing Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
MULTIDOSE MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Programming with Volume/Duration Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Programming with Volume/Duration Disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
REVIEWING SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
REVIEWING SOFTWARE VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
ALARMS, ERRORS, MESSAGES
DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
MAINTENANCE
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Shared Infusion Settings (Pump Module and Syringe Module) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Pump Module Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
APPENDIX
TRUMPET AND START-UP CURVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
ii TABLE OF CONTENTS Pump Module, 8100 Series
Directions for Use

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.
The Medley™Pump Module is indicated for use on adults,
pediatrics, and neonates.
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 an 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.
Compliance with Federal Aviation Regulations: The
Medley™Pump Module has received a Statement of
Compliance with Federal Aviation Regulations for use as a
“Portable Electronic Device Aboard Aircraft”. This is pursuant
to the FAA Advisory Circular No. 91-21-1A and attested by an
FAA Designated Engineering Representative with an FAA form
8110-3, “Statement of compliance with the Federal Aviation
Regulations”.
Contraindications: None known.
This document provides directions for use for the Medley™
Pump Module.
NOTE: The Medley™Point-of-Care Unit was formerly known as
the Medley™Programming Module.
INTRODUCTION
INTRODUCTION
INTRODUCTION 1
Pump Module, 8100 Series
Directions for Use
About the Pump Module
Read all instructions, for both the
Pump Module and Point-of-Care
Unit, before using the Medley™
System.
WARNING

2INTRODUCTION Pump Module, 8100 Series
Directions for Use
Reference the “Alarms, Errors, Messages” chapter of the Medley™Point-of-Care Unit Directions for Use
(DFU) for the definitions of various alerts. Reference the Point-of-Care Unit DFU for system features
and definitions.
Auto-Restart Part of Medley™System’s advanced Downstream Occlusion
Detection system. If enabled, it minimizes nuisance patient-side
occlusion alarms caused by momentary kinking of tubing, IV pushes,
etc.
Bolus Dose Allows a bolus infusion to be programmed using either the
Guardrails®Drug Library or drug calculation feature. It can be
programmed with or without a continuous infusion following a bolus.
Channel Labels Available when Profiles feature is enabled. It provides a hospital-
defined list of labels, displayed in Channel (Module) Message
Display, and identifies module with the solution being infused,
catheter location, or other helpful information.
Concentration Limits Limits specified for the range of concentrations allowed for a
particular drug in a profile.
Delay Options Allows system to be programmed to delay start of an infusion a) for
up to 120 minutes or b) for a specific time up to 23 hours 59 minutes.
Acallback for a programmed delay can be scheduled to give an alert
Before an infusion is to be initiated, After an infusion is completed,
Before and After an infusion, or no alert (None).
Drug Calculation 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 Appears on Main Display. If enabled, it graphically displays current
patient-side occlusion pressure set point and 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.
Features and Definitions

Guardrails®Drug Library 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. Drug
Library use automates programming steps, including drug name,
drug amount and diluent volume, and activates hospital-established
best-practice Guardrails®Limits.
Guardrails®Limit A programming limit or best-practice guideline determined by
hospital/health system and entered into system’s data set. Supports
concentration limits for all infusions that utilize concentration. 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 hospital/health system as
either “hard” or “soft” limits.
• A Guardrails®Hard Limit is a programmed limit that cannot be
overridden, except in anesthesia mode.
• A Guardrails®Soft Limit is a programmed limit that can be
overridden.
KVO Rate Adjust Used to select KVO (Keep Vein Open) rate (0.1 to 20 mL/h allowed),
which is the rate of fluid flow after an “Infusion Complete” occurs.
The KVO rate will never exceed the infusion rate.
Multidose Mode 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
maximum occlusion pressure of 525 mmHg.
•Auto-Restart: (See “Auto-Restart” definition.)
In addition, the Medley™System provides fluid-side occlusion
detection.
Rapid Bolus Fastest rate at which bolus dose should be delivered, as defined by
facility’s clinical best-practice guidelines.
INTRODUCTION
INTRODUCTION 3
Pump Module, 8100 Series
Directions for Use
Features and Definitions (Continued)

4INTRODUCTION Pump Module, 8100 Series
Directions for Use
Restore To simplify programming, 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.
Secondary Infusions Dual rate sequential piggyback (secondary) infusions may be infused
at delivery rates and volumes independent of 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 Allows a volume-to-be-infused (VTBI) and duration (infusion time) to
be programmed. The flow rate is automatically calculated.
Features and Definitions (Continued)
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 Point-of-Care Unit and attached modules.
Manufacturing Date: Number adjacent to symbol indicates month and year of
manufacture.
Consult operating instructions.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on order of a
physician.
Single-Use. Do not re-use.
Product contains micron filter, where XX represents filter size.
Symbols
+75
IPX1
!
MM-YYYY
nly
O
2
Single-Use
XX
µm

INTRODUCTION
INTRODUCTION 5
Pump Module, 8100 Series
Directions for 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
XX ml
XX
Symbols (Continued)

6INTRODUCTION Pump Module, 8100 Series
Directions for Use
THIS PAGE
INTENTIONALLY
LEFT BLANK

GETTING STARTED
GETTING STARTED
GETTING STARTED 7
Pump Module, 8100 Series
Directions for Use
Warnings and Cautions provided throughout this Directions for
Use (DFU) provide information needed to safely and
effectively use the Medley™Pump Module and accessories.
Medley™System Warnings and Cautions, and definitions, are
covered in the Point-of-Care Unit DFU.
Warnings and Cautions
General
nly
O
• The Medley™Pump Module is designed to stop fluid flow
under alarm conditions. Periodic patient monitoring must
be performed to ensure the infusion is proceeding as
expected. It 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.
• 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.
• 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.
WARNINGS

•Epidural administration of drugs other than those
indicated for epidural use could result in serious injury to
the patient.
• 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.
• The Medley™System can be used for epidural
administration of anesthetic and analgesic drugs. This
application is only appropriate when using anesthetics and
analgesics labeled for continuous epidural administration
and catheters intended specifically for epidural use. Use
only a Medley™System/Gemini Series administration set,
without a ‘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.
WARNINGS
8GETTING STARTED Pump Module, 8100 Series
Directions for Use
Warnings and Cautions (Continued)
Epidural Administration
Guardrails®Safety Software
• The Guardrails®Safety Software incorporates dosing
limits and instrument configuration parameters based on
hospital/facility protocol. The software adds a test of
reasonableness to drug programming based on the limits
defined by the hospital/facility. Qualified personnel must
ensure the appropriateness of drug dosing limits, drug
compatibility, and instrument performance, as part of the
overall infusion. Potential hazards include drug
interactions, inaccurate delivery rates and pressure alarms,
and nuisance alarms.
• 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.
WARNINGS

• 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, reference the Set Compatibility Card (provided
separately).
•Discard if packaging is not intact or protector caps are
unattached.
WARNINGS
GETTING STARTED
GETTING STARTED 9
Pump Module, 8100 Series
Directions for Use
Warnings and Cautions (Continued)
Administration Sets
Before operating instrument, verify that administration set is
free from kinks and installed correctly in instrument.
CAUTION

10 GETTING STARTED Pump Module, 8100 Series
Directions for Use
INFUSE
STANDBY
ALARM
CHANNEL
SELECT
CHANNEL
OFF
PAUSE
RESTART
Operating Features, Controls and Indicators
Front/Side View - Door Closed
Infusing
(green)
Alarm
(red)
IUI Connector, Left
Standby
(yellow)
Rate Display
Channel (Module) Message Display
Channel (Module) Identification
Door Handle
Channel (Module) Select Key: When
pressed, selects corresponding module for
infusion parameter entry and infusion
setup.
Pause Key: When pressed during an
infusion, temporarily stops infusion on that
module. After approximately 2 minutes, a
visual and audio prompt begins.
Channel (Module) Off Key: When
pressed and held until a beep is heard,
stops infusion on that module, deselects
that module, and if only that module had
been operating, system powers down.
Repeat for other operating modules to
power off each module.
Restart Key: When pressed, resumes
operation of a previously paused or
alarmed infusion on that module.
Status Indicators IUI Connector, Right
(not visible)
Module Release Latch:
When pressed, allows
module to be removed.

GETTING STARTED
GETTING STARTED 11
Pump Module, 8100 Series
Directions for Use
Operating Features, 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®Device Recess
Air-in-Line Sensor
Upper Occluder
Lower Occluder
Upper Pumping Finger
Lower Pumping Finger
IUI Connector, Left
(not visible)

12 GETTING STARTED Pump Module, 8100 Series
Directions for Use
Although the dynamic pressure
display bars for the Medley™Syringe
Module and Pump Module both use
the full width of the screen for
display, they each represent
different ranges. The Pump
Module’s range is 50 to 525 mmHg.
CAUTION
Installation
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 in use.
Prior to placing the Medley™System in use: Perform check-in
procedure per Medley™Maintenance Software/User Manual
(Model 8970C, or later).
Dynamic Pressure Display
VTBI = 250.0 mL
VOLUME
INFUSED
AUDIO
ADJUST
Midtown Hospital
Adult ICU
Dynamic Pressure Display
Current operating pressure is
indicated by solid bar.
Patient-side occlusion pressure
set point is indicated by tick
mark.
Attaching and Detaching Modules
Reference the Medley™Point-of-Care Unit DFU.
The displays illustrated throughout this document are for
illustration purposes only. The display content will vary,
depending on configuration settings, type of administration set
in use, hospital-defined data set uploaded using the
Guardrails®Safety Software, programmed drug calculation
parameters, and many other variables. Refer to specific drug
product labeling for information concerning appropriate
administration techniques and dosages.
Main Display
Displays
Reference the Medley™Point-of-Care Unit DFU.

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, reference
directions for use provided with set.
• The primary set must be primed before use (reference
“Priming Primary Administration Set” section). It can be
loaded into Pump Module to deliver a large volume infusion
(reference “Loading and Removing Primary Administration
Set” section) or it can be set up to deliver a gravity infusion
(reference “Setting Up Primary Administration Set for
Gravity Infusion” section).
• Use aseptic technique when handling sets.
• Administration sets are supplied with a sterile and
nonpyrogenic fluid path for one-time use. Do not
resterilize.
• For administration set replacement interval, refer to facility
protocol and/or government standards (such as, CDC
guidelines in United States).
• Discard administration set per facility protocol.
• For IV push medication (put instrument on hold), clamp
tubing above port.
• Flush port(s) per facility protocol.
• Flo-Stop®Device is a tubing fitment that is part of all
Medley™System/Gemini sets (reference “Flo–Stop®Device”
section).
GETTING STARTED
GETTING STARTED 13
Pump Module, 8100 Series
Directions for Use
Reference the Medley™Point-of-Care Unit DFU for the
following procedures:
Powering On System
Responding to Maintenance Reminder
Selecting New Patient and Profile Options
Entering Patient ID
Modifying Patient ID
Start-Up
Preparing Infusion
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
Administration Set

When a new Medley™System/Gemini administration set is
removed from the package, the Flo-Stop®Device is in the
open position (white slide clamp aligned with blue fitment). In
this open position, flow is not occluded but is allowed as
required for the priming process. The roller clamp is used to
control flow during the priming process (reference “Priming
Primary Administration Set” section).
14 GETTING STARTED Pump Module, 8100 Series
Directions for Use
Flo-Stop®Device
The primary administration set’s Flo-Stop®Fitment is a unique
clamping device that prevents inadvertent free-flow when the
administration set is removed from the instrument.
Flo-Stop®Device in Open Position Blue Fitment
White Slide Clamp
-- OPEN --
Preparing Infusion (Continued)
Administration Set (Continued)
SmartSite®Needle-Free System
• The SmartSite®Needle-Free Valve Port is contraindicated
for blunt cannula systems.
• Swab the top of the 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.

GETTING STARTED
GETTING STARTED 15
Pump Module, 8100 Series
Directions for Use
Preparing Infusion (Continued)
Flo-Stop®Device in Closed Position
When a Medley™System/Gemini administration set is
removed from the Pump Module, the instrument automatically
engages the Flo-Stop®Device in the closed position (white
slide clamp projects out from under blue fitment). In this
closed position, flow is occluded.
Blue Fitment
White Slide Clamp
-- CLOSED --
Flo-Stop®Device (Continued)
1. Prepare primary solution container in accordance with
manufacturer’s directions for use.
2. Open administration set package, remove set, and close
roller clamp. (Reference set’s Directions For Use.)
3. Insert administration set spike into prepared fluid
container, following accepted hospital/facility procedure,
and hang container 20 inches above Pump Module.
4. Fill drip chamber to 2/3full.
5. If container requires venting, open vent cap on
administration set spike.
6. To prime tubing and clear air from injection sites and
tubing fitments, slowly open roller clamp.
7. When priming is complete, close roller clamp.
8. Verify no fluid flow.
Priming Primary Administration Set

16 GETTING STARTED Pump Module, 8100 Series
Directions for Use
c. Press Flo-Stop®Fitment into recess below
mechanism.
d. Using a finger tip, firmly push tubing toward back of
Air-in-Line (AIL) Detector.
When reloading an administration
set, leave the Flo-Stop®Fitment in
the closed position (reference “Flo-
Stop®Device” section).
CAUTION
Flo-Stop®Fitment
Push tubing toward
back of AIL Detector.
Loading and Removing Primary Administration Set
Loading Administration Set
1. If a new set is being loaded, prime set (reference “Priming
Primary Administration Set” section).
2. Open Pump Module door.
3. Load administration set, as follows:
a. Hold upper fitment above fitment recess and lower
into recess.
b. Ensure tubing is not twisted.
Insert upper fitment BEFORE
installing the Flo-Stop®Fitment.
CAUTION
Preparing Infusion (Continued)