Alaris Medical Systems Medley 8000 Series Manual

POINT-OF-CARE UNIT
8000 SERIES
SILENCE
OPTIONS
1 4
7
CLEAR
2
5
8
0
3
6
9
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ENTER
CANCEL
SYSTEM
ON
Directions for Use
Point-of-Care Unit, 8000 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]
SPECIAL PRODUCT NOTE
This document and some display screens make reference to
a module that is not currently available, the Medley™EtCO2
Module. At the time of this publication, the Medley™EtCO2
Module has not been released for commercial sale and ALARIS
Medical Systems, Inc. may never make the EtCO2Module
available for commercial sale.

TABLE OF CONTENTS
INTRODUCTION
ABOUT THE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
FEATURES AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
GETTING STARTED
WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
OPERATING FEATURES, CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
ATTACHING AND DETACHING MODULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Attaching Module(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Detaching Module(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Adding Module(s) While System is Powered On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Adjusting Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
START-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Powering On System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Responding to Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Selecting New Patient and Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Entering Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Modifying Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
ADJUSTING AUDIO VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
SETTING UP TIME OF DAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
REVIEWING SYSTEM CONFIGURATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
REVIEWING SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
REVIEWING SOFTWARE VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
POWERING OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Powering Off System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Powering Off Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
LOCKING/UNLOCKING TAMPER RESIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
ALARMS, ERRORS, MESSAGES
DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
AUDIO CHARACTERISTICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
ERRORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
MAINTENANCE
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SYSTEM CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
TABLE OF CONTENTS i
Point-of-Care Unit, 8000 Series
Directions for Use

ii TABLE OF CONTENTS Point-of-Care Unit, 8000 Series
Directions for Use
MAINTENANCE (Continued)
BATTERY CARE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Battery Type and Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Battery Cautions and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

INTRODUCTION
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. It consists of the Point-of-Care Unit (8000
Series), the Guardrails®Safety Software, and up to
4detachable modules (or “channels”) which provide infusion
or monitoring capabilities.
NOTE: The Medley™Point-of-Care Unit was formerly known as
the Medley™Programming Module.
The Medley™Point-of-Care Unit 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.
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 and concentration guidelines for up to 10 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.
Concentration limits can only be Guardrails®Soft Limits.
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 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™Point-of-Care Unit, and can be
accessed using the Guardrails®Continuous Quality
Improvement (CQI) Standard Software.
About the System
INTRODUCTION
INTRODUCTION 1
Point-of-Care Unit, 8000 Series
Directions for Use

Compliance with Federal Aviation Regulations: The
Medley™Point-of-Care Unit 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™
Point-of-Care Unit. For additional operating instructions,
reference the Directions for Use (DFU) for the individual
Medley™Module(s).
2INTRODUCTION Point-of-Care Unit, 8000 Series
Directions for Use
Reference the “Alarms, Errors, Messages” chapter of this DFU for the definitions of various alerts.
Reference the DFU that applies to the attached Medley™Module(s) for features and definitions specific
to that module.
Anesthesia Mode Allows anesthesiologist to access additional drugs, in each profile,
that are appropriate to anesthesiology. It also features permanent
pause. Clinical Advisories will not be displayed in this mode.
Battery Run Time Display Appears on Main Display prompt bar when Point-of-Care Unit is
disconnected from AC. If enabled, this feature provides a visual
display of estimated remaining battery run time under current
operating conditions, when operating on battery.
Concentration Limits Limits specified for the range of concentrations allowed for a
particular drug in a profile.
Data Set Created using Guardrails®Editor authoring tool and then transferred
to Point-of-Care Unit. A data set reflects facility’s best-practice
guidelines for IV drug administration and includes: Profile Drug
Libraries, Clinical Advisories, instrument configurations, and Channel
Label Libraries.
Features and Definitions
About the System (Continued)
Read all instructions before using
the Medley™System.
WARNING

INTRODUCTION
INTRODUCTION 3
Point-of-Care Unit, 8000 Series
Directions for Use
Features and Definitions (Continued)
Dose Checking Always Dose Checking option causes a Guardrails®Soft Alert to
occur each time a dose limit is exceeded. Drug label in Message
Display provides an indicator (“---” or “LLL”) that infusion is beyond
current Guardrails®Soft Limit.
Smart Dose Checking option causes an initial Guardrails®Soft Alert
to occur when a dose limit is exceeded. Subsequent programming
beyond dose limit will not receive an alert. Drug label in Message
Display provides an indicator (“---” or “LLL”) if infusion is beyond
current Guardrails®Soft Limit.
Guardrails®Safety Software Designed to help prevent programming errors by:
• Customizing device configurable settings to meet need of
selected hospital/facility area/unit (profile).
• Comparing user programming with hospital-defined best-practice
guidelines.
• Providing a Guardrails®Prompt if an out-of-limits entry is made.
Patient ID Entry An optional alphanumeric 16-character patient identifier can be
entered and displayed.
• When enabled, ID entry defaults to Startup screen.
• When disabled, ID entry is only accessible from System Options
screen.
Profile A unique set of system configuration settings and best-practice
guidelines for a specific patient population or patient type, and
consists of following 3components:
• 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 modules that are actively infusing nondrug
therapies (for example, saline or TPN). Channel labels can also
be used to identify 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 transferred to the Point-of-Care Unit.
System Configuration Allow system settings to be customized. If Profiles feature is
enabled, system settings defined for selected profile are
automatically activated.
Tamper Resist Provides a quick one-touch lockout of front panel keypad.

Alarm silence (pauses audio alarm for 120 seconds).
Alternating Current: Indicates 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).
Type CF defibrillation-proof equipment.
Communications connector for RS-232 attachment.
Electrostatic discharge (ESD).
Fuse Replacement: Replace fuse only with same type and rating.
Protection against fluid ingress: Drip Proof
IUI Connector: Inter-Unit Interface connector used to establish power and communications
between Point-of-Care Unit and attached modules.
Main Power: Connected to alternating current, 100-240 VAC.
Manufacturing Date: Number adjacent to symbol indicates month and year of manufacture.
Potential Equalization Conductor (if so equipped). Note: If integrity of PEC or Hospital Earth
System is in question, operate instrument using internal battery power.
Radio frequency (RF) radiation.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on order of a physician.
“SYSTEM ON”
Tamper Resist activate/deactivate switch.
4INTRODUCTION Point-of-Care Unit, 8000 Series
Directions for Use
Symbols
+75
IPX1
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MM-YYYY

GETTING STARTED
GETTING STARTED
GETTING STARTED 5
Warnings and Cautions
• 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.
• Do not use the Medley™System near Magnetic Resonance
Imaging (MRI).
• Disconnect from main (AC) and battery power when
performing maintenance.
• Electrical shock hazard. Do not open case. Refer to
qualified service personnel.
• Use of accessories or cables other than those specified
may result in degraded electromagnetic compatibility
performance of this instrument.
WARNINGS
nly
O
Point-of-Care Unit, 8000 Series
Directions for Use
Warnings and Cautions are provided throughout this
Directions for Use (DFU) to provide information needed to
safely and effectively use the Medley™Medication Safety
System and its accessories. Module-specific Warnings and
Cautions are covered in the applicable module’s DFU.
A is an alert to an imminent hazard which
could result in serious personal injury and/or product damage
if proper procedures are not followed.
A is an alert to a potential hazard which could
result in serious personal injury and/or product damage if
proper procedures are not followed.
A is an alert to a potential hazard which could
result in minor personal injury and/or product damage if proper
procedures are not followed.
CAUTION
WARNING
DANGER
Explosion risk if used in the presence of flammable anesthetics.
DANGER

6GETTING STARTED Point-of-Care Unit, 8000 Series
Directions for Use
Warnings and Cautions (Continued)
• The Medley™System is not intended to replace
supervision by medical personnel. The user must
become thoroughly familiar with the Medley™System
features, operation and accessories prior to use.
• Always use a grounded, three-wire receptacle. Where
the integrity of the protective earth grounding system is in
doubt, operate on internal battery.
• 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.
• If an instrument appears damaged, contact ALARIS
Medical Systems for authorization to return it for repair.
CAUTIONS

SYSTEM
ON
Operating Features, Controls and Indicators
Front/Side View
IUI Connector, Left
(not visible)
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 2 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
connected to a server or
computer. When blinking,
indicates data transfer.
Module Release Latch:
When pressed, allows
module to be removed.
Clear Key: When
pressed, clears current
selected parameter setting
to “0”.
IUI Connector, Right
System On Key: When
pressed, changes Medley™
System from Standby to
Operating mode.
Up/Down Arrows: When
pressed, increases or decreases
parameter with each key press or
scrolls 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
GETTING STARTED 7
Point-of-Care Unit, 8000 Series
Directions for Use

8GETTING STARTED Point-of-Care Unit, 8000 Series
Directions for Use
Operating Features, Controls and Indicators (Continued)
Rear View
IUI Connector, Right IUI Connector, Left
Primary Audio Speaker
Connector Plug over RJ45
Communication Data Port
Tamper Resist Switch
Power Cord Strap
Option Upgrade Panel
Use this bolt to reorient
Pole Clamp 90°for
attachment to a bed rail
instead of a pole.

GETTING STARTED
GETTING STARTED 9
Point-of-Care Unit, 8000 Series
Directions for Use
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:
1. Perform check-in procedure per Medley™Maintenance
Software/User Manual (Model 8970C, or later).
2. Verify whether or not Profiles feature has been enabled.
Reference “Reviewing System Configuration” section in
“Getting Started” chapter.
NOTE: To enable the Profiles feature, a hospital-defined
best-practice data set must be uploaded to the Point-of-Care
Unit.
1. Position free module at a 45°angle, aligning IUI
connectors.
2. Rotate free module down against Point-of-Care Unit or
attached module, until bottom latch snaps in place.
NOTES:
• Individual hospital/facility may choose to permanently attach
modules. To remove permanently attached modules, contact
qualified service personnel.
• Application of adhesive tape or other materials to the sides of
the Point-of-Care Unit and modules may prevent proper
latching.
Modules can be attached to either side of the Point-of-Care
Unit or to either side of another module. The process to
attach or detach is the same for either side, whether
attaching/detaching to/from a Point-of-Care Unit or another
module.
Attaching and Detaching Modules
Attaching Module(s)
45°
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 module as described in “Attaching Module(s)”.
• System tests module, causing all LED segments and
indicator lights of displays to illuminate briefly.
• Appropriate module identification display (A, B, Cor D)
illuminates. Modules are always labeled left to right, so if a
module is added to left of other modules, all modules will
be reidentified. Module reidentification does NOT interrupt
or affect infusion or monitoring on active modules.
• Module positions (A, B, Cor D) appear on Main Display.
NOTE: If any of the following conditions are observed, the
affected module must be removed from use and inspected by
qualified personnel:
•LED segments are not illuminated on displays during power-
on test.
• Indicator lights do not illuminate.
• Appropriate module identification (A, B, Cor D) is not
displayed.
If the affected module operates normally when it is attached via
the alternate IUI connector, it may be used until a replacement
module can be substituted.
10 GETTING STARTED Point-of-Care Unit, 8000 Series
Directions for Use
Adding Module(s) While System is Powered On
IUI Connectors
Detaching Module(s)
1. Ensure module(s) is powered off before detaching.
2. Push module release latch (located directly below IUI
connectors) and then rotate module(s) up and away from
Point-of-Care Unit or attached module (opposite to motion
shown above) to disengage connectors.
• Medley™System reidentifies and shows appropriate
module identification (A, B, Cor D), from left to right.
• Appropriate module position(s) (A, Bor C) for
remaining module(s) appear on Main Display.
NOTE: The Medley™Medication Safety System is designed to
operate a maximum of 4infusion or monitoring modules.
Modules added in excess of 4will not be recognized by the
system. The module(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
Attaching and Detaching Modules (Continued)

GETTING STARTED
GETTING STARTED 11
Point-of-Care Unit, 8000 Series
Directions for Use
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.
Title Bar
Module Status
• A solid letter display indicates
module is operating.
• An outlined letter display
indicates module is attached
and ready for use.
Soft Keys
SYSTEM
ON
Displays
Main Display
Module 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.
>Press START
Infusion Setup
RATE 40
mL/h
_250 mL
PAUSE
SECOND-
ARY
START
VTBI
SYSTEM
ON

1. Connect Point-of-Care Unit to an external AC power
source.
2. Press SYSTEM ON.
3. System self test begins:
• Diagnostics test causes all LED display segments and
Status Indicator lights of attached module(s) to
illuminate briefly.
• Power Indicator illuminates.
• Appropriate module identification (A, B, Cor D)
displays on attached module(s).
• An Audio tone sounds.
12 GETTING STARTED Point-of-Care Unit, 8000 Series
Directions for Use
Start-Up
Powering On System
Displays (Continued)
1. Press OPTIONS key.
2. Select Display Contrast soft key.
3. To adjust display for optimum viewing, use
Lighter/Darker soft keys.
4. To return to main screen, press MAIN SCREEN 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
®
-- Continued on Next Page --

GETTING STARTED
GETTING STARTED 13
Point-of-Care Unit, 8000 Series
Directions for Use
Start-Up (Continued)
Powering On System (Continued)
• At completion of system-on test, New Patient? screen
appears.
• If PM Reminder option is enabled and scheduled
preventive maintenance is due, MAINTENANCE
REMINDER screen appears.
NOTES:
• Previous infusion parameters are automatically cleared after
8hours.
• If any of the following conditions are observed, the Point-of-
Care Unit or the affected attached module 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 module 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 module operates normally when it is attached
via an alternate IUI connector, it may be used until a
replacement module can be substituted.
If the Preventive Maintenance (PM) Reminder option is
enabled and the Point-of-Care Unit or an attached module is
due for preventive maintenance, a MAINTENANCE REMINDER
message appears at power up.
NOTES:
• If necessary, the reminder can be temporarily bypassed by
pressing the CONFIRM soft key.
• Notify the appropriate facility personnel when a MAINTENANCE
REMINDER occurs.
1. Remove and, if needed, replace module requiring
maintenance with a new module (reference “Attaching
and Detaching Modules” section).
Responding to Maintenance Reminder
CONFIRM
B
MAINTENANCE REMINDER
Module(s) due for routine
preventive maintenance:
Module A:
YYYY-MM-DD

14 GETTING STARTED Point-of-Care Unit, 8000 Series
Directions for Use
Selecting New Patient and Profile Options
Start-Up (Continued)
The option to enter and display a 16-character alphanumeric
patient identifier is always available. The instrument may be
configured to automatically display the Patient ID Entry
screen during start up or to provide access only through the
Systems Options menu.
The following procedures assume the Profiles feature is
enabled.
NOTE: The display contrast can be adjusted at this time by
pressing the DISPLAY CONTRST soft key and following the
directions on the screen (also reference “Displays”, “Adjusting
Display Contrast” section).
CONFIRM
B
MAINTENANCE REMINDER
Module(s) due for routine
preventive maintenance:
Responding to Maintenance Reminder (Continued)
2. If “system” (Point-of-Care Unit and attached modules)
was powered off to replace Point-of-Care Unit, reinitiate
start-up process.
OR
If an “attached module” (such as, a Pump Module) was
powered off and removed, MAINTENANCE REMINDER
display reflects removal of that module. To continue
start–up process, press CONFIRM soft key.

1. Select required NEW PATIENT? option.
To indicate programming is for a new patient and clear all
stored patient parameters from memory, press Yes soft
key.
OR
To confirm programming is for same patient and retain all
stored patient parameters, press No soft key.
• Last used profile displays.
NOTE: If the Profiles feature is disabled, the main menu
appears.
2. Select correct profile.
To accept current profile, press Yes soft key and proceed
to step 5.
• Main screen appears.
OR
To change profile, press No soft key and continue with
next step.
• Profile selection screen appears.
3. To select a profile, press corresponding left soft key.
NOTE: To view additional choices, press PAGE DOWN soft
key.
4. To confirm profile selection, press CONFIRM soft key.
• Main screen appears.
5. To enter Patient ID, if desired, reference “Entering Patient
ID” section.
GETTING STARTED
GETTING STARTED 15
Point-of-Care Unit, 8000 Series
Directions for Use
Start-Up (Continued)
Patient ID Entry Feature Disabled
Midtown Hospital
Yes
No
NEW PATIENT ?
>Select Yes or No
“Yes” Clears Previous
Patient Data
DISPLAY
CONTRST
Midtown Hospital
Adult ICU
Yes
No
>Select Yes or No
Adult ICU ?
“Yes” Confirms Same
Profile
Selecting New Patient and Profile Options (Continued)
Midtown Hospital
Profiles
>Select a Profile and
Confirm
CONFIRM
PAGE
DOWN
Neonatal
Peds ICU
Neonatal ICU
Adult General Care
Adult ICU
1of2

1. Select required NEW PATIENT? option.
• To indicate programming is for a new patient and clear
all stored patient parameters from memory:
a. Press Yes soft key.
♦Patient ID Entry screen appears.
b. If patient identifier is not required, press CONFIRM
or EXIT soft key.
OR
Enter patient identifier (reference “Entering Patient
ID” section).
♦Last used profile displays.
-- OR --
• To confirm programming is for same patient and retain
all stored patient parameters, press No soft key.
♦Last used profile displays.
NOTE: If the Profiles feature is disabled, the main menu
appears.
2. Select correct profile.
To accept current profile, press Yes soft key.
• Main screen appears.
OR
To change profile, press No soft key and continue with
next step.
• Profile selection screen appears.
16 GETTING STARTED Point-of-Care Unit, 8000 Series
Directions for Use
Start-Up (Continued)
Selecting New Patient and Profile Options (Continued)
EXIT
A
B
C
D
PAGE
DOWN
>Enter Patient ID and Press
CONFIRM
E
K-O
F-J
P-T
U-Y
A-E
Patient ID Entry
________________
CONFIRM
Midtown Hospital
Adult ICU
Yes
No
>Select Yes or No
Adult ICU ?
“Yes” Confirms Same
Profile
Patient ID Entry Feature Enabled
Midtown Hospital
Yes
No
NEW PATIENT ?
>Select Yes or No
“Yes” Clears Previous
Patient Data
DISPLAY
CONTRST