ALARIS Medical Systems Medley 8000 User Guide

DIRECTIONS FOR USE

MEDICATION SAFETY SYSTEM

PROGRAMMING MODULE

OPTIONS

SILENCE

CLEAR

1

4

7

5

8

0

2

9

6

.

3

CANCEL

ENTER

SYSTEM

ON

8000 Series

Medley™

8000 SERIES

PROGRAMMING MODULE

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: [e-mail]

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]

THIS PAGE

INTENTIONALLY

LEFT BLANK

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 multi­disciplinary 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

2 INTRODUCTION

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.

4 INTRODUCTION

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

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

O

nly

• 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.

6 GETTING 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 high­energy 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.

8 GETTING 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.