Alaris Medical Systems Medley 8000 Series Manual

SILENCE
OPTIONS
1 4
7
CLEAR
2
5
8
0
3
6
9
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ENTER
CANCEL
SYSTEM
ON
Medley™
MEDICATION SAFETY SYSTEM
PROGRAMMING MODULE
8000 Series
DIRECTIONS FOR USE
PROGRAMMING MODULE
8000 SERIES

TABLE OF CONTENTS
INTRODUCTION
ABOUT THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
GETTING STARTED
WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Unpacking Programming Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
ATTACHING AND DETACHING CHANNELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Attaching Channel(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Detaching Channel(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Adding Channel(s) While System is Powered On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Adjusting Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Selecting New Patient and Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Modifying Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
ADJUSTING AUDIO VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
SETTING UP TIME OF DAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
REVIEWING SYSTEM CONFIGURATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
REVIEWING SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
REVIEWING SOFTWARE VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
VIEWING AND CLEARING GUARDRAILS®EVENT COUNTER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Powering Off Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
LOCKING/UNLOCKING TAMPER RESIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
COMPUTER LINK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
ALARMS, ERRORS, MESSAGES
DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
MAINTENANCE
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
SYSTEM CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
INTRODUCTION GETTING STARTED ALARMS, ERRORS,
MESSAGES
MAINTENANCE
TABLE OF CONTENTS i

ii TABLE OF CONTENTS
MAINTENANCE (Continued)
STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
BATTERY CARE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Battery Type and Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Battery Cautions and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Product Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

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 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.
The Medley™ Programming Module is the core of the Medley™
System and provides a common user interface for programming
infusions and monitoring, which helps to reduce complexity at
the point of care.
NOTE: The Medley™ Programming Module name will be changing
in the near future to Medley™ Point-of-Care Unit.
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.
This document provides directions for use for the Medley™
Programming Module. Read all instructions before using the
Medley™ System. For additional operating instructions,
indications for use and contraindications, refer to the Directions
for Use for the individual system module(s).
About the System
INTRODUCTION

2INTRODUCTION
Refer to the “Alarms, Errors, Messages” chapter of this Directions for Use for the definitions of various
alerts. Refer to the Directions for Use that applies to the attached Medley™ Module(s) for features and
definitions specific to that module.
Anesthesia Mode The Anesthesia Mode allows the anesthesiologist to access additional
drugs, in each profile, that are appropriate to anesthesiology. It also
features permanent pause.
Battery Run Time Display The Battery Run Time Display appears on the Main Display prompt bar
when the Programming Module is disconnected from AC. If enabled,
this feature provides a visual display of the estimated remaining battery
run time under the current operating conditions, when operating on
battery.
Data Set A data set is created using the Guardrails®Editor authoring tool and
then electronically transferred to the Medley™ Programming Module.
A data set reflects the facility’s best-practice guidelines for IV drug
administration and includes: profile drug libraries, clinical advisories,
instrument configurations, and channel label libraries.
Dose Checking The Always Dose Checking option causes a Guardrails®Soft Alert to
occur each time a dose limit is exceeded. The drug label in the Channel
Message Display provides an indicator (“↑↑↑” or “LLL”) that the infusion
is beyond the current Guardrails®Soft Limit.
The Smart Dose Checking option causes an initial Guardrails®Soft Alert
to occur when a dose limit is exceeded. Subsequent programming
beyond the dose limit will not receive an alert. The drug label in the
Channel Message Display provides an indicator (“↑↑↑” or “LLL”) if the
infusion is beyond the current Guardrails®Soft Limit.
Ease of Use To enhance safety and ease of operation, the Medley™ System provides
a full range of audio and visual alarms, errors, and messages.
Guardrails®Safety Software The Guardrails®Safety Software is designed to help prevent
programming errors by:
• Customizing device configurable settings to meet the need of the
selected hospital area/unit (profile).
• Comparing user programming with hospital-defined best-practice
guidelines.
• Providing a Guardrails®Prompt if an out-of-limits entry is made.
Features and Definitions

INTRODUCTION 3
Features and Definitions (Continued)
INTRODUCTION
Patient ID Entry An optional alphanumeric 16-character patient identifier can be
entered and displayed.
• When enabled, the ID entry defaults to the Startup screen.
• When disabled, the ID entry is only accessible from the System
Options screen.
Pole Clamp The Medley™ Programming Module pole clamp adapts to a wide
variety of surfaces, to provide versatility. The pole clamp features
include:
• Ergonomically designed knob.
• Accommodates diameters from 5/8to 13/8inches (15.9 to 34.9 mm).
• Vertical or horizontal orientation, allowing it to adapt to both IV
poles and bed rails.
Profile A Profile is a unique set of system configuration settings and best-
practice guidelines for a specific patient population or patient type, and
consists of the following three components:
• Instrument configuration settings.
• A Guardrails®Drug Library, which includes drug names, standard
concentrations, dosing units, Guardrails®Limits, and optional
associated clinical advisories for both continuous and bolus dose
infusion.
• A Channel Label Library with text (alphanumeric) labels, that allows
identification of channels that are actively infusing nondrug
therapies (for example, saline or TPN). Channel labels can also be
used to identify the route of delivery (for example, epidural).
Profile settings are established by the facility’s own multi-disciplinary
team prior to system implementation. Profile parameters are used to
create a data set, which is then electronically transferred to the
Programming Module.
System Configuration System Configurations allow system settings to be customized. If the
Profiles feature is enabled, the system settings defined for the selected
profile are automatically activated.
Tamper Resist The Tamper Resist feature provides a quick one-touch lockout of the
front panel keypad.

Alternating Current: Indicates that device should be attached to alternating current source,
50/60 Hz only.
Attention: Refer to accompanying documentation.
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).
Communications Connector: For RS-232 attachment.
Protection against fluid ingress: Drip Proof
Fuse Replacement: Replace fuse only with same type and rating.
IUI Connector: Inter-Unit Interface connector used to establish power and communications
between the Programming Module and attached modules.
Main Power: Connected to alternating current, 100-240 VAC.
Manufacturing Date: Number adjacent to symbol indicates the month and year of
manufacture.
Potential Equalization Conductor (if so equipped). Note: If the integrity of the PEC or Hospital
Earth System is in question, operate the instrument using internal battery power.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
“SYSTEM ON”
Tamper Resist activate/deactivate switch.
4INTRODUCTION
Symbols
+75
IPX1
!
nly
O
MM-YYYY

NOTE: Although the Medley™ Medication Safety System is built
and tested to exacting specifications, it is not intended to replace
the supervision by medical personnel. The user should become
thoroughly familiar with the features and operation of the Medley™
System and exercise vigilance in its utilization.
GETTING STARTED
GETTING STARTED 5
GETTING STARTED
Warnings and Cautions
For WARNINGS and CAUTIONS for detachable module(s), refer to
the individual module’s Directions for Use.
To ensure proper performance of the Medley™ System and to
reduce potential injury, observe the following precautions:
When properly secured/snapped, the bottom latch provides a
very secure connection between modules. If not properly
latched, a module can be dislodged during operation.
WARNING
nly
O
To ensure proper performance of the Medley™ System and to
reduce potential injury to the operator, observe the following
precautions:
• Always use a grounded, three wire receptacle. Where the
integrity of the protective earth grounding system is in doubt,
operate on internal battery.
• Disconnect from main (AC) and battery power when
performing maintenance.
User Precautions
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
Do not use the Medley™ System in close proximity of Magnetic
Resonance Imaging (MRI).
WARNING

• The instrument case should only be opened by qualified
service personnel using proper grounding techniques.
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.
6GETTING STARTED
Warnings and Cautions (Continued)
User Precautions (Continued)
Explosion hazard. Do not use in the
presence of flammable anesthetics.
DANGER
Electrical shock hazard. Do not open
case. Refer to qualified service
personnel.
WARNING

GETTING STARTED 7
GETTING STARTED
Use of accessories or cables other
than those specified may result in
degraded electromagnetic
compatibility performance of this
device.
WARNING
Warnings and Cautions (Continued)
User Precautions (Continued)
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.

8GETTING STARTED
IUI Connector, Left
(not visible)
SYSTEM
ON
Controls and Indicators
Front/Side View
Main Display
Soft Keys - When pressed,
allows selection of options or
infusion parameters appearing
on Main Display adjacent to soft
key.
Silence Key - When pressed
during an alarm, silences
audio for two minutes.
Options Key - When pressed,
allows access to available
System or Channel Options.
Soft Keys (see above).
Battery Indicator - When
illuminated, indicates Medley™
System is operating on battery
power.
Power Indicator - When
illuminated, indicates Medley™
System is connected to an AC
power source.
Computer Monitor Mode
Indicator - When illuminated,
indicates Medley™ System is
operating in Computer Monitor
mode.
Channel Release Latch -
When pressed, allows channel
to be removed.
Clear Key - When pressed,
clears current selected
parameter setting to “0”.
IUI Connector, Right
Handle
System On Key - When pressed,
changes Medley™ System from
Standby to Operating mode.
Up/Down Arrows - When
pressed, will increase or decrease
parameter with each key press or
will scroll up and down when
pressed and held.
Enter Key - When pressed,
confirms current parameter entry.
Cancel Key - When pressed,
sequentially backs out of current
setup sequence.
Decimal Key - When pressed,
inserts a decimal point in numeric
data.
Numeric Keypad

GETTING STARTED 9
GETTING STARTED
Controls and Indicators (Continued)
Rear View
IUI Connector, Right IUI Connector, Left
Pole Clamp Knob
Primary Audio Speaker
Connector Plug over RJ45
Communication Data Port
Tamper Resist Switch
AC Power Cord Safety
Retainer
Power Cord Strap
Option Upgrade Panel
(for future use)
Handle
Use this bolt to reorient Pole
Clamp 90°for attachment to
a bed rail instead of a pole.

1. Remove Programming Module from its carton.
2. Check pole clamp for freedom of operation.
3. Check AC power entry module for contamination.
4. Check for loose parts.
5. Plug module into an AC outlet for 24 hours prior to use.
Maximum battery capacity, as well as gauge accuracy, is
reached after several charge/discharge/charge cycles. For
best results, fully charge/discharge/charge battery before
placing in use.
6. Perform Periodic Inspections (see “Inspection Requirements”
section in “Maintenance” chapter).
7. Perform check-in procedure [reference Medley™
Maintenance Software User Manual (included with 8970C,
or later) for details].
If the Programming Module is damaged, contact ALARIS Medical
Systems for authorization to return the equipment for repair.
Instruments are tested and calibrated before they are packaged
for shipment. To ensure proper operation after shipment, it is
recommended that an incoming inspection be performed before
placing the instrument in use.
To enable the Profiles feature, a hospital-defined best-practice
data set must be uploaded to the Programming Module. Prior
to placing the Medley™ System in use, verify whether or not the
Profiles feature has been enabled (reference “Reviewing System
Configuration” section in “Getting Started” chapter).
10 GETTING STARTED
Unpacking Programming Module
Installation

1. Position free channel at a 45°angle, aligning IUI
Connectors.
2. Rotate free channel down against Programming Module or
attached channel, until bottom latch snaps in place.
NOTES:
• Individual hospitals may choose to permanently attach channels.
To remove permanently attached channels, contact qualified
service personnel.
• Application of adhesive tape or other materials to the sides of
the Programming Module and channels may prevent proper
latching.
Channels can be attached to either side of the Programming
Module or to either side of another channel. The process to
attach or detach is the same for either side, whether
attaching/detaching to/from a Programming Module or another
channel.
GETTING STARTED 11
GETTING STARTED
Attaching and Detaching Channels
Attaching Channel(s)
45°
Detaching Channel(s)
1. Ensure channel(s) is powered off before detaching.
2. Push channel release latch (located directly below IUI
Connectors) and then rotate channel(s) up and away from
Programming Module or attached channel (opposite to
motion shown above) to disengage connectors.
• Medley™ System reidentifies and shows appropriate
channel identification (A, B, Cor D), from left to right.
• Appropriate channel position(s) (A, Bor C) for remaining
channel(s) appear on Main Display.
NOTE: The Medley™ Medication Safety System is designed to
operate a maximum of four channels. Channels added in excess of
four will not be recognized by the system. The channel(s) can be
attached in any position; however, when mounted on an IV pole, it
is recommended that a balanced configuration be maintained.
Release Latch
When properly secured/snapped, the
bottom latch provides a very secure
connection between modules. If not
properly latched, a module can be
dislodged during operation.
WARNING

Add channel as described in “Attaching Channel(s)”.
• System tests channel, causing all LED segments and Indicator
lights of channel displays to illuminate briefly.
• Appropriate channel identification display (A, B, Cor D)
illuminates. Channels are always labeled left to right, so if a
channel is added to left of other channels, all channels will be
reidentified. Channel reidentification does NOT interrupt or
affect infusion or monitoring on active channels.
• Channel positions (A, B, Cor D) appear on Main Display.
NOTE: If any of the following conditions are observed, the
affected channel must be removed from use and inspected by
qualified personnel:
• LED segments are not illuminated on channel displays during
power-on test.
• Indicator lights do not illuminate.
• Appropriate channel identification (A, B, C or D) is not
displayed.
If the affected channel operates normally when it is attached via the
alternate IUI connector, it may be used until a replacement channel
can be substituted.
12 GETTING STARTED
VTBI = 250.0 mL
VOLUME
INFUSED
AUDIO
ADJUST
Midtown Hospital
Adult ICU
The displays illustrated throughout this document are for
illustration purposes only. The display content will vary,
depending on configuration settings, hospital-defined data set
uploaded using the Guardrails®Safety Software, and many other
variables.
Attaching and Detaching Channels (Continued)
Adding Channel(s) While System is Powered On
IUI Connectors
Title Bar
Channel Status
• A solid channel letter display
indicates channel is operating.
• An outlined channel letter
display indicates channel is
attached and ready for use.
Soft Keys
SYSTEM
ON
Displays
Main Display

Channel Selected Indicator
“Inactive” Soft Key
Nonhighlighted indicates a
nonselected soft key.
“Active” Soft Key
Highlighted indicates a selected
soft key.
Prompt Bar
Look here for user prompts.
GETTING STARTED 13
GETTING STARTED
Displays (Continued)
1. Press OPTIONS key.
2. Select D
DiissppllaayyCCoonnttrraassttsoft key.
3. To adjust display for optimum viewing, use L
Liigghhtteerr//DDaarrkkeerr
soft keys.
4. To return to main screen, press MAIN SSCREEN soft key.
System Options 1 of 3
>Select an Option or
EXIT
PAGE
DOWN
EXIT
Display Contrast
Time of Day
Power Down All Channels
Anesthesia Mode
Patient ID
Adjusting Display Contrast
System Options
>Adjust Display to
Desired Contrast
MAIN
SCREEN
Display Contrast
Lighter
Darker
Medley ™
Medication Safety System
®
>Press START
Infusion Setup
RATE 40
mL/h
_250 mL
PAUSE
SECOND-
ARY
START
VTBI
SYSTEM
ON
Main Display (Continued)

1. Connect Programming Module to an external AC power
source.
2. Press SYSTEM OON.
3. System self test begins:
• Diagnostics test causes all LED display segments and
Status Indicator lights of attached channel(s) to
illuminate briefly.
• Power Indicator illuminates.
• Appropriate channel identification (A, B, Cor D) displays
on attached channel(s).
• An Audio tone sounds.
• At completion of system-on test, N
NeewwPPaattiieenntt??screen
appears.
• If PM Reminder option is enabled and scheduled
preventive maintenance is due, MAINTENANCE RREMINDER
screen appears.
NOTES:
• Previous infusion parameters are automatically cleared after eight
(8) hours.
• If any of the following conditions are observed, the Programming
Module or the affected channel must be removed from use and
inspected by qualified personnel:
♦LED segments are not illuminated during system-on test.
♦Indicator lights do not illuminate.
♦Appropriate channel identification (A, B, Cor D) is not
displayed.
♦Audio tone does not sound.
♦Main Display does not appear backlit, appears irregular, or has
evidence of a row of pixels not functioning properly.
If the affected channel operates normally when it is attached via
an alternate IUI connector, it may be used until a replacement
channel can be substituted.
14 GETTING STARTED
Start-Up
Powering On System