ALARIS Medical Systems Medley User Guide

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Programming Module, 8000 Series

Medication Safety System

Medle

™

Directions for Use

OPTIONS

SILENCE

CLEAR

CANCEL

ENTER

SYSTEM

8000 SERIES

PROGRAMMING MODULE

GENERAL CONTACT INFORMATION

Customer Advocacy - North America

Clinical and product application support.

Phone: (800) 854-7128, Ext. 7812

E-Mail: CustomerFeedback@alarismed.com

Technical Support - North America

Maintenance and service information support.

United States:

Phone:

(858) 458-6003 (800) 854-7128, Ext. 6003

Canada:

Phone:

Eastern: (800) 908-9918 Western: (800) 908-9919

Customer Care - North America

Instrument return, service assistance, and order placement.

United States:

Phone:

(800) 482-4822

Canada:

Phone:

(800) 387-8309

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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adding Module(s) While System is Powered On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

COMPUTER LINK

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

ALARMS, ERRORS, MESSAGES

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

AUDIO CHARACTERISTICS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

ALARMS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

ERRORS

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

MAINTENANCE

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

SYSTEM CONFIGURABLE SETTINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

STORAGE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

TABLE OF CONTENTS

Programming Module, 8000 Series

Directions for Use

ii TABLE OF CONTENTS

Programming Module, 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

INSPECTION REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 Programming Module (

8000 Series), the Guardrails

Safety Software, and up to four detachable modules (or “channels”) which provide infusion or monitoring capabilities.

NOTE: The Medley™Programming Module name will be changing in the near future to Medley™Point-of-Care Unit. During this transition, there will be a period of time when screen displays, software, and instrument labeling might reflect either "Programming Module" or "Point-of-Care Unit".

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.

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 drugspecific 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 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) Standard Software.

About the System

INTRODUCTION

Programming Module, 8000 Series

Directions for Use

Compliance with Federal Aviation Regulations: The Medley

™

Programming 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

™

Programming Module. For additional operating instructions, reference the Directions for Use (DFU) for the individual Medley™Module(s).

2 INTRODUCTION

Programming Module, 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 Programming Module 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.

Data Set Created using Guardrails

Editor authoring tool and then transferred to Programming Module. 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.

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.

Features and Definitions

About the System (Continued)

Read all instructions before using the Medley

™

System.

WARNING

INTRODUCTION

Programming Module, 8000 Series

Directions for Use

Features and Definitions (Continued)

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

-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 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 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 Programming Module.

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.

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).

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 Programming Module 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.

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.

4 INTRODUCTION

Programming Module, 8000 Series

Directions for Use

Symbols

IPX1

nly

MM-YYYY

GETTING STARTED

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

Programming Module, 8000 Series

Directions for Use

Explosion risk if used in the presence of flammable anesthetics.

DANGER

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

nly

6 GETTING STARTED

Programming Module, 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

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 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 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

Programming Module, 8000 Series

Directions for Use

8 GETTING STARTED

Programming Module, 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

Programming Module, 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 Programming Module.

1. Position free module at a

45°

angle, aligning

IUI

connectors.

2. Rotate free module down against Programming Module 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 Programming Module and modules may prevent proper latching.

Modules can be attached to either side of the Programming Module 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 Programming Module or another module.

Attaching and Detaching Modules

Attaching Module(s)

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

45°

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 (

B, C or 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, C or 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, C or 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

Programming Module, 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 Programming Module or attached module (opposite to motion shown above) to disengage connectors.

• Medley

™

System reidentifies and shows appropriate

module identification (A, B, C or D), from left to right.

• Appropriate module position(s) (

A, B or C) for

remaining module(s) appear on Main Display.

NOTE: The Medley™Medication Safety System is designed to operate a maximum of four infusion or monitoring modules. Modules added in excess of four will 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

Programming Module, 8000 Series

Directions for Use

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

mL/h

_250

PAUSE

SECOND-

ARY

START

VTBI

SYSTEM ON

Midtown Hospital Adult ICU

VTBI = 250.0 mL

VOLUME INFUSED

AUDIO

ADJUST

1. Connect Programming Module 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, C or D)

displays on attached module(s).

• An Audio tone sounds.

12 GETTING STARTED

Programming Module, 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.

Adjusting Display Contrast

System Options

>Adjust Display to Desired Contrast

MAIN

SCREEN

Display Contrast

Lighter

Darker

Medley

™

Medication Safety System

-- Continued on Next Page --

System Options 1 of 3

Display Contrast

Patient ID

Time of Day

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

DOWN

PAGE

GETTING STARTED

Programming Module, 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 eight (

) hours.

• If any of the following conditions are observed, the Programming Module 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, C or 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 Programming Module 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

MAINTENANCE REMINDER

Module(s) due for routine

preventative maintenance:

Module A:

CONFIRM

YYYY-MM-DD

14 GETTING STARTED

Programming Module, 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).

Responding to Maintenance Reminder (Continued)

2. If “system” (Programming Module and attached modules) was powered off to replace Programming Module, reinitiate start-up process.

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.

MAINTENANCE REMINDER

Module(s) due for routine

preventative maintenance:

CONFIRM

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.

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

• Main screen appears.

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

Programming Module, 8000 Series

Directions for Use

Start-Up (Continued)

Patient ID Entry Feature Disabled

Midtown Hospital Adult ICU

Yes

>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

Midtown Hospital

NEW PATIENT ?

“Yes” Clears Previous Patient Data

>Select Yes or No

DISPLAY

CONTRST

Yes

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

soft key.

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.

To change profile, press No soft key and continue with next step.

• Profile selection screen appears.

16 GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Start-Up (Continued)

Selecting New Patient and Profile Options (Continued)

Midtown Hospital Adult ICU

Yes

>Select Yes or No

Adult ICU ?

“Yes” Confirms Same Profile

Patient ID Entry Feature Enabled

Midtown Hospital

Yes

NEW PATIENT ?

>Select Yes or No

“Yes” Clears Previous Patient Data

DISPLAY

CONTRST

Patient ID Entry

CONFIRM

A-E

F-J

K-O

P-T

U-Y

PAGE

DOWN

________________

>Enter Patient ID and Press CONFIRM

EXIT

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.

GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Start-Up (Continued)

Patient ID Entry Feature Enabled

(Continued)

Entering Patient ID

Selecting New Patient and Profile Options (Continued)

When the Patient ID Entry feature is disabled, the Patient ID Entry screen can only be accessed through the Systems Options menu. To enter a patient

ID, begin with step 1 of the

following procedure.

When the Patient

ID Entry feature is enabled, the Patient ID

Entry screen appears after responding Yes to New Patient? prompt. To enter a patient ID, begin with step 2 of the following procedure.

1. To access Patient

ID Entry screen:

a. Press

OPTIONS key.

• System Options menu appears.

b. Press Patient

ID soft key.

• Patient

ID Entry screen appears.

Midtown Hospital Profiles

>Select a Profile and Confirm

CONFIRM

PAGE

DOWN

Neonatal

Peds ICU

Neonatal ICU

Adult General Care

Adult ICU

1of2

System Options 1 of 3

Display Contrast

Patient ID

Time of Day

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

DOWN

PAGE

2. To enter patient identifier, use numeric data entry keys and/or alpha speed keys.

NOTES:

• An alphanumeric identifier, of up to 16

characters, can be

entered.

• Press the soft key next to a letter group to list letters in that group. Press the soft key next to an individual letter to enter that letter.

• To access the letter “

Z” and special characters (hyphen,

underscore, space), press the

PAGE DOWN soft key.

• To clear an entire entry, press CLEAR key.

• To back up a single character at a time, press

CANCEL

key.

3. To verify correct entry, press CONFIRM soft key.

• If accessed from New Patient? screen, last used

profile appears.

• If accessed from Systems Options menu, main

screen appears.

• Patient

ID appears on main screen, current profile

screen, and New Patient? screen.

18 GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Entering Patient ID (Continued)

EXIT

PAGE

DOWN

>Enter Patient ID and Press CONFIRM

K-O

F-J

P-T

U-Y

A-E

Patient ID Entry

123456789CD_____

CONFIRM

Start-Up (Continued)

Modifying Patient ID

1. Press OPTIONS key.

• System Options menu appears.

2. Press Patient

ID soft key.

• Patient

ID Entry screen appears.

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

Patient ID Entry

CONFIRM

A-E

F-J

K-O

P-T

U-Y

PAGE

DOWN

________________

>Enter Patient ID and Press CONFIRM

EXIT

3. To clear entire entry, press CLEAR key.

To back up a single character at a time, press CANCEL key.

4. To enter modified patient identifier, use numeric data entry keys and/or alpha speed keys.

NOTES:

• An alphanumeric identifier, of up to

16 characters, can be

entered.

• Press the soft key next to a letter group to list letters in that group. Press the soft key next to an individual letter to enter that letter.

• To access the letter “Z” and special characters (hyphen, underscore, space), press the

PAGE DOWN soft key.

5. To verify correct entry, press CONFIRM soft key.

• Patient

ID Entry verification screen appears.

6. To accept modified Patient

ID, press Yes soft key.

• Main screen appears with new Patient

ID.

To retain original (old) Patient

ID, press No soft key.

• Main screen appears with old Patient

ID.

GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Start-Up (Continued)

Modifying Patient ID (Continued)

EXIT

PAGE

DOWN

>Enter Patient ID and Press CONFIRM

K-O

F-J

P-T

U-Y

A-E

Patient ID Entry

________________

CONFIRM

EXIT

PAGE

DOWN

>Enter Patient ID and Press CONFIRM

K-O

F-J

P-T

U-Y

A-E

Patient ID Entry

234567891EF_____

CONFIRM

>Press Yes or No

Patient ID Entry

Yes

Patient ID 123456789CD will be changed to 234567891EF

Is this correct?

Patient ID Entry

123456789CD

>Enter Patient ID and Press CONFIRM

EXIT

CONFIRM

PAGE

DOWN

A-E

F-J

K-O

P-T

U-Y

1. Press Audio Adjust soft key.

2. To change volume to desired level, press either Louder or Softer soft key. To sample alarm loudness level, Test soft key may be pressed.

3. To return to Programming Module screen, press

MAIN

SCREEN soft key.

• After

30 seconds without a key press, Main Display

appears.

20 GETTING STARTED

Programming Module, 8000 Series

Directions for Use

1. Press OPTIONS key.

2. Press Time of Day soft key.

3. Press Change Time soft key.

Setting Up Time of Day

Time of Day

System Options

Current time:

__:__

Change

Time

CONFIRM

Adjusting Audio Volume

Louder

>Change Setting or Cancel

Audio Volume Adjust

Test

Softer

MAIN

SCREEN

VTBI = 250.0 mL

VOLUME

INFUSED

AUDIO

ADJUST

Midtown Hospital Adult ICU

System Options

Time of Day

Current time:

09:00

CONFIRM

Change

Time

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key.

3. Press System Configuration soft key.

4. Select Programming Module.

5. To review various system configuration settings, press

PAGE UP and PAGE DOWN soft keys.

NOTES:

• The Profiles option is listed only if it is disabled.

• The Dose Checking option is listed only if the Profiles option is enabled and a valid data set is present.

GETTING STARTED

Programming Module, 8000 Series

Directions for Use

4. Enter current Time of Day.

5. Press Confirm soft key.

NOTE: The format is a 24-hour clock (military time).

Reviewing System Configuration

Factory Default:

Yes

System Config - Module 1 of 2

Programming Module

Pump Module

SPO2 Module

>Press CANCEL or EXIT

EXIT

Shared Infusion Settings

PAGE

DOWN

Setting Up Time of Day (Continued)

>Select an Option or EXIT

PAGE

DOWN

EXIT

System Config - PM 1 of 2

Alarm audio:

Profile 1

Battery meter:

Disabled

Clock setup:

09:00

Key click audio:

Enabled

Anesthesia Mode: Disabled

>Select an Option or EXIT

EXIT

PAGE

System Config - PM 2 of 2

Profiles:

Tamper resist:

500 kg

Max Pt. weight:

Patient ID Entry:

Disabled

PM Reminder:

Disabled

6. To return to main screen, press CANCEL key or EXIT soft key.

System Options

Time of Day

Current time:

14:30

CONFIRM

Change

Time

1. Press OPTIONS key.

2. Press Page Down soft key.

3. Press Serial Numbers soft key.

• Serial numbers for Programming Module and all

attached modules display.

NOTE: “nnnn-nnnnnnnn” in the illustrated display represents a serial number.

4. To return to main screen, press EXIT soft key.

22 GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Reviewing Serial Number

System Options 2 of 3

PAGE

System Configuration

>Select an Option or EXIT

EXIT

Software Versions

Serial Numbers

Battery Runtime

PAGE

DOWN

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

PM:

>Press CANCEL or EXIT

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key.

3. Press Software Versions soft key.

4. To review software version information, press View soft key next to desired module.

To return to main screen, press EXIT soft key

5. To return to previous screen, press

EXIT soft key.

NOTE: “nn.nn” in the illustrated display represents a

software version.

GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Reviewing Software Version

Software Rev. Review

APM:

Module A:

Module B:

Module C:

Module D:

View

>Select an Option or EXIT

EXIT

>Press CANCEL or EXIT

Software Rev. Review

Module Software: A

Main processor:

nn.nn

Main boot block:

Keyboard:

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

System Options 2 of 3

Battery Runtime

System Configuration

Serial Numbers

Software Versions

>Select an Option or EXIT

PAGE

EXIT

PAGE

DOWN

1. Press OPTIONS key.

2. Press Power Down All Channels soft key.

3. Press Yes soft key.

• During power off sequence, Main Display flashes

POWERING DOWN.

24 GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Powering Off

Powering Off System

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

Press and hold CHANNEL OFF key until a beep is heard (approximately

1.5 seconds) and then release to initiate power

down.

NOTE: To interrupt the power down sequence, quickly press any one of the numeric keys on the Programming Module.

• During power off sequence, Main Display flashes

Powering Down.

• Once all attached modules are powered off, Programming

Module automatically powers down.

Powering Off Module

Powering Down

System Options

Power Down All Channels?

>Press Yes or No

Yes

1. Initiate operation of desired modules.

2. Press and hold Tamper Resist Switch, on back of Programming Module, for three to four seconds. An advisory tone and a three-second

PANEL LOCKED prompt

on Main Display confirm activation. When Tamper Resist is active, keypad panel is locked; however, clinician may:

• Silence key for audio alarm.

• View volume(s) infused.

• View and test audio alarm setting.

• View selected parameters on SpO

Module.

Any other key press will result in a visual

PANEL LOCKED

prompt and, if Key Click Audio is enabled, an illegal key–press audio advisory.

3. To unlock keypad panel, press and hold Tamper Resist Switch for three to four seconds. A three-second

PANEL

UNLOCKED prompt on Main Display and, if Key Click

Audio is enabled, an advisory tone confirms Tamper

Resist is off.

GETTING STARTED

Programming Module, 8000 Series

Directions for Use

Locking/Unlocking Tamper Resist

PANEL UNLOCKED

VTBI = 250.0 mL

VOLUME INFUSED

AUDIO

ADJUST

Midtown Hospital Adult ICU

VTBI = 250.0 mL

PANEL LOCKED

VOLUME INFUSED

AUDIO

ADJUST

26 GETTING STARTED

Programming Module, 8000 Series

Directions for Use

The optional Computer Link feature allows a hospital/facility computer to interact with the instrument. The computer cannot start or stop the instrument, set the rate, or make any change in status. If the feature is off, the computer cannot communicate with the instrument.

The Computer Link option is available in the Maintenance Mode.

The computer interface uses a three wire RS-232 signal definition through an

RJ45 type connector. The table to the

right shows the pin definition. Do not connect anything to the unused pins.

Qualified service personnel can turn the Computer Link feature on or off.

Pin Number

Description

Ground

RS-232 TxD

(out of Programming Module)

RS-232 RxD

(into Programming Module)

Computer Link

Only systems that have been tested and certified in compliance to

IEC 601–1/EN 60601–1 standard

should be connected to the Medley

™

System Computer/Connections port.

CAUTION

Use of accessories or cables other than those specified may result in degraded electromagnetic compatibility performance of this device.

CAUTION

To assure continued electromagnetic compatibility performance, the communications cable which attaches to the instrument should be a category

type cable, no longer than 3 meters.

CAUTION

Advisory / Message A sequence of audio and/or visual signals indicating operating status

of Medley™Medication Safety System. Audio may be silenced for approximately two minutes by pressing SILENCE key.

Alarm An audio and visual signal that a potentially unsafe condition is

present. Immediate action is required. Audio may be silenced for approximately two minutes by pressing

SILENCE key.

Error An audio and/or visual signal that a failure has been detected.

Immediate action is required.

Guardrails

Alert A visual message to help reduce programming errors by indicating a

Guardrails®Limit (“soft” or “hard”) has been exceeded. A response is required before programming can continue.

Guardrails

Clinical Advisory A visual message when a designated drug is selected, to remind

clinician of specific hospital/facility standards of practice when programming an IV medication. A specific clinical advisory/message can be associated with a selected drug within any of the patient care profiles. Clinical Advisories will not be displayed in Anesthesia mode.

Maintenance Reminder A visual message that, when enabled, appears at module startup

when scheduled preventive maintenance is due/overdue for any part of Medley

™

System (Programming Module or attached module).

Prompt A visual message, appearing on bottom line of Main Display or in

Message Display. Message may be accompanied by an audio signal that can be silenced for twelve seconds by pressing

SILENCE key.

ALARMS, ERRORS, MESSAGES

ALARMS, ERRORS,

MESSAGES

ALARMS, ERRORS, MESSAGES

To enhance safety and ease of operation, the Medley™System provides a full range of audio and visual alarms, errors, and messages.

NOTE: 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.

Definitions

Programming Module, 8000 Series

Directions for Use

Advisory / Message

Alarm

Error (Hardware Detected)

Error (Software Detected)

Illegal Key Press

Key Click

Prompt

SpO

Alarm

Switchover

One short beep every two seconds

Choice of three alarm audio profiles, selectable in System Configuration

Pairs of long beeps

Two short beeps

One short beep

One short beep every two seconds

Unique alarm pattern.

Six short beeps: secondary switching to primary. Two short beeps: bolus switching to continuous.

Variable volume; can be silenced for two minutes.

Fixed maximum decibel volume; cannot be silenced.

Fixed maximum decibel volume; can be silenced for two minutes.

Variable volume; cannot be silenced.

Fixed minimum volume; can be silenced and disabled in System Configuration.

Variable volume; can be silenced.

Different sound than other alarms.

Variable volume; can be silenced and disabled in System Configuration.

28 ALARMS, ERRORS, MESSAGES

Programming Module, 8000 Series

Directions for Use

Audio Characteristics

The Programming Module and Main Display provide various types of alert information. The characteristics of the accompanying audio sounds are as follows:

Type Sound Notes

Battery Discharged

Channel Disconnected

Very Low Battery <5 minutes to system shutdown

Operation of all modules stopped due to insufficient battery charge.

Module(s) disconnected while in operation or have a communication problem.

Battery has five minutes or less of power at current power consumption rate before operation stops.

Connect AC power cord to power source; alarm will be silenced. Press RESTART key on Pump Module to continue operation of paused modules.

To silence alarm and clear message from screen, press

CONFIRM soft key. Reattach

module, if desired, ensuring it is securely “clicked” into place at Module Release Latch. If alarm is still present, replace module with an operational instrument.

Connect

AC power cord to power

source; alarm will be silenced.

ALARMS, ERRORS,

MESSAGES

ALARMS, ERRORS, MESSAGES

Programming Module, 8000 Series

Directions for Use

Alarms

Alarm Meaning Response

Channel Error

Defective Battery

Hardware Detected Error

Error detected. Operation stops on affected module.

Defective battery detected.

Error detected on Programming Module. Operation stops on all modules.

To silence alarm and continue operation of unaffected modules, press CONFIRM soft key . Replace module with an operational instrument, as required. Service by qualified personnel is required.

To power down system, press

SYSTEM OFF soft key; or to

continue temporary operation while an operational Programming Module can be located, press

SILENCE key. Service by qualified

personnel is required.

Press SYSTEM ON key to power down system. Replace Programming Module with an operational system. Service by qualified personnel is required.

Errors

Error Meaning Response

Missing Battery

Power Supply Error

System Error

Battery detected as not present or not connected.

Power supply system malfunction detected.

Error detected on Programming Module. Operation continues on all attached modules.

To power down system, press

SYSTEM OFF soft key; or to

continue temporary operation while an operational Programming Module can be located, press

SILENCE key. Service by qualified

personnel is required.

Disconnect AC power immediately. To power down system, press

SYSTEM OFF soft key; or to

continue operation under battery power while an operational Programming Module can be located, press SILENCE key. Service by qualified personnel is required.

To power down system, press

SYSTEM OFF soft key; or to

continue temporary operation while an operational Programming Module can be located, press

SILENCE key. Service by qualified

personnel is required.

30 ALARMS, ERRORS, MESSAGES

Programming Module, 8000 Series

Directions for Use

Battery Run Time = X.X hours

Low Battery

Panel Locked

Panel Unlocked

power cord is disconnected from power source. Approximate remaining battery run time under current power consumption rate is displayed.

Low battery threshold sensed; remaining battery run time is limited.

Tamper Resist feature is active and key was pressed.

Tamper Resist feature deactivated.

None. Connect AC power cord to power source as soon as possible.

Connect

AC power cord to power

source; alarm will be silenced.

If appropriate, deactivate Tamper Resist feature using Tamper Resist Control on back of Programming Module.

None.

Messages

Message Meaning Response

Errors (Continued)

Error Meaning Response

Powering Down

Replace Battery

Last module powering off. System shuts off in indicated number of seconds.

Occurs at System On. Battery has less than 50%

of original capacity.

Press any key, except

SYSTEM ON

key, to cancel power down sequence.

Press either SYSTEM OFF or

CONFIRM soft key to continue

normal operation with reduced battery capacity. Service by qualified personnel is required.

ALARMS, ERRORS,

MESSAGES

ALARMS, ERRORS, MESSAGES

Programming Module, 8000 Series

Directions for Use

Messages (Continued)

Message Meaning Response

32 ALARMS, ERRORS, MESSAGES

Programming Module, 8000 Series

Directions for Use

THIS PAGE

INTENTIONALLY

LEFT BLANK

Battery Operation: Battery run time is a function of the number of modules attached and module

activity. With a new, fully charged battery, the system will operate as follows before a "

BATTERY DISCHARGED

" message occurs:

•8hours with 1 Pump Module infusing at 25 mL/h

•

4 hours with 4 Pump Modules infusing at 25 mL/h

• 6 hours with 1 active SpO2Module

•

8 hours with 1 Syringe Module infusing at 5 mL/h

• 4 hours with 4 Syringe Modules infusing at 5 mL/h

Communication Data Port:

RS-232 with an RJ45 connector.

Dimensions: 6.9"W x 8.8"H x 9"D (including pole clamp)

Electric Classification: Class 1, Internally Powered Equipment

NOTE: Reference module specific Directions for Use for shock protection type

and defibrillation-proof rating information.

Electronic Memory: System configuration parameters stored in volatile memory will be retained for at

least 6 months by the internal backup lithium battery. Additionally, modulespecific parameters are stored for 8 hours by the Programming Module and then automatically purged by the system.

Environmental Conditions: Operating Storage/Transport

Temperature Range:

41 to 104°F

-4 to 140°F

(5 to 40°C)(-20 to 60°C)

Relative Humidity: 20 to 90% 5 to 85%

(Avoid prolonged exposure

Noncondensing Noncondensing

to relative humidity >85%)

Atmospheric Pressure: 525 to 4560 mmHg 375 to 760 mmHg

(700 to 6080 hPa) (500 to 1013 hPa)

Equipment Orientation: To ensure proper operation, the instrument must remain in an upright position.

Fluid Ingress Protection:

IPX1, Drip Proof

Leakage Current: Less than 100 microamps

Power Requirements: 100 - 240V ~, 50/60 Hz, 150 VA MAX (See Notes 1 and 2)

Weight: 7.2 lbs

The Medley™System Technical Service Manual is available from

ALARIS Medical Systems. It includes

routine service schedules, interconnect diagrams, component parts lists and descriptions, test procedures, and other technical information, to assist qualified service personnel in repair and maintenance of the instrument’s repairable components. Maintenance procedures are intended to be performed only by qualified personnel, using the service manual and Medley

™

Maintenance Software.

MAINTENANCE

Programming Module, 8000 Series

Directions for Use

Specifications

NOTES:

1. Power Cords; North America:

To ensure correct polarity and grounding reliability, use power cords that incorporate a NEMA 5-15P (125V) or NEMA 6-15P (250V) plug only.

2. Power Cords; International:

Use only cords that comply with

IEC 60245, or IEC 60227, designation #53 and local electrical codes and/or

regulations.

3. Compliance to Standards:

The Medley

™

Medication Safety System has been assessed and complies with the following standards:

UL 60601–1; CSA C22.2 No. 601.1, including A1 and A2; IEC/EN 60601–2–24; IEC/EN 60601–1–2 and AAMI ID26.

34 MAINTENANCE

Programming Module, 8000 Series

Directions for Use

Specifications (Continued)

System Configurable Settings

Profile 1, 2 or 3

Enabled - Disabled

Set date and time

Always, Smart

Enabled - Disabled

0.1 - 500 kg

Enabled - Disabled

Feature

Alarm Audio

Anesthesia Mode

Battery Meter

Clock Setup (Date and Time)

Dose Checking

Key Click Audio

Max Patient Weight

Patient ID Entry

PM Reminder (Preventive Maintenance)

Profiles

Tamper Resist

Default Setting Options

Profile 1

Disabled

N/A

Always

Enabled

500 kg

Disabled

Enabled

Disabled

If the configuration settings need to be changed from the "Factory Default" settings, reference the applicable Technical Service Manual or contact ALARIS Medical Systems, Technical Support, for technical, troubleshooting, and preventive maintenance information.

NOTE: With the Profiles feature enabled, the settings are configured independently for each profile. A hospital-defined, best-practice data set must be uploaded to enable the Profiles feature. Date and Time is a system setting and is the same in all profiles.

The Medley™Programming Module is equipped with a 12 volt,

4000 mAh nickel metal hydride battery. The battery is

charging whenever the instrument is plugged into an

receptacle. The life expectancy of the battery is dependent on the amount of use, the depth of discharge, and the state of the charge that is maintained. Generally, the battery will have the longest life if the instrument is plugged in and battery use is infrequent. Frequent use of battery power and insufficient battery charge cycles will significantly decrease the life of the battery.

The quality of the battery is also a significant factor in determining battery life and runtime. The battery cannot be repaired and should not be opened. Replace the battery with the same type, size and voltage rating. Use of any other brand may yield poor performance and is not recommended.

Batteries should be charged in a room with a temperature between

50 - 80.6

°F (10 - 27°C), to minimize charge time and

maximize battery life.

MAINTENANCE

Programming Module, 8000 Series

Directions for Use

Plug the Programming Module into an AC outlet during storage, to ensure a fully charged battery when needed.

(

AC indicator light) will be on whenever the Programming

Module is plugged in.

Battery Care and Maintenance

Battery Type and Charging

Storage

Battery Charge

• The Medley™Programming Module is shipped with the battery in a discharged condition.

• Before the Programming Module is released for use, it should be plugged into a hospital grade

AC outlet and the

battery charged for at least eight hours. This will ensure proper battery operation when the Medley

™

System is first

set up for patient use.

• Whenever possible, leave the power cord connected to an external

AC power source while operating the instrument.

The battery capacity should be checked at least once every six months. Reference the Medley

™

System Technical Service

Manual for test and replacement procedures.

If the Programming Module is to be stored at temperatures in excess of

°F (30°C) for one or more months, the battery should be removed and placed in an environment of 50– 86°F (10 –

30°C).

If the batteries are to be stored for more than one year, they should be charged at least once per year to prevent leakage and deterioration in performance due to self-discharge.

When the battery is first being put into use, or has been out of use for one or more months, it will not have full capacity due to deactivation of reactants.

Restore such batteries to original performance by repeating one or two cycles of fully charging and fully discharging.

Some temporary reduction in capacity might become apparent if the battery is partially discharged repeatedly. Doing one or two cycles of full discharge and full charge can restore full performance.

36 MAINTENANCE

Programming Module, 8000 Series

Directions for Use

Battery Care and Maintenance (Continued)

Battery Care

Battery Cautions and Disposal

Battery replacement should be performed by qualified service personnel while the instrument is not in use.

DO NOT

open, incinerate or short circuit. Worn–out batteries must be disposed of properly, according to local regulations.

CAUTION

MAINTENANCE

Programming Module, 8000 Series

Directions for Use

DO NOT spray cleaning fluids directly onto the instrument or

immerse the instrument in fluids.

DO NOT use solutions containing phosphoric acid (Foamy

Q&A

*), aromatic solvents (naphtha, paint thinner,

etc.), chlorinated solvents* (Trichloroethane,

MEK,

Toluene, etc.), ammonia, acetone, benzene, xylene or alcohol, other than as specified below.

DO NOT use hard or pointed objects to clean any part of the

instrument.

Acceptable cleaning solutions are:

Warm water Mild detergent (

such as, Manu-Klenz)

10%

bleach solution (1 part bleach to 9 parts water

) Compublend II Envirocide

2% Glutaraldehyde in water

Hydrogen Peroxide

70% Isopropyl Alcohol 2%

Phenols in water (O-Syl 1:128, Pheno-Cen 1:256,

Vesphene

)

10% Providone Iodine (Betadine)

Quaternaries 1:512

WEX-CIDE

NOTE: All recommended solutions must be diluted per the Manufacturer’s recommendation.

1. Keep instrument upright and do not allow any part of instrument to become saturated with or submersed in fluid during cleaning operation.

2. Use a soft cloth dampened with warm water and a mild nonabrasive cleaning solution to clean all exposed surfaces. For sanitizing or antibacterial treatment, use 10% bleach solution and water.

NOTE: A soft-bristled brush may be used to clean hard to reach and narrow areas.

3. Use a soft cloth dampened with water to rinse off cleaning solution.

* Excluding 10% bleach solution in water.

Cleaning

Turn the instrument off and unplug the power cord from the AC power source before cleaning. Do not spray fluids directly onto the rear case of the instrument. Do not steam autoclave, EtO sterilize, immerse the instrument or allow fluids to enter the instrument case. Failure to follow these instructions may result in an electrical hazard.

WARNING

The solutions/solvents identified as

NOT to be used can damage the

surfaces of the instrument.

CAUTION

To ensure the system remains in good operating condition, both regular and preventive maintenance inspections are required. Reference the Medley™Maintenance Software/User Manual (Model 8970C, or later) for detailed instructions.

REGULAR INSPECTIONS

PROCEDURE FREQUENCY

INSPECT FOR DAMAGE:

Exterior Surface Each usage Pole Clamp Each usage Power Cord Each usage Keypad Each usage

CLEANING As required

Start-Up Each usage

38 MAINTENANCE

Programming Module, 8000 Series

Directions for Use

NOTE: If the instrument shows evidence of damage in transit, notify the carrier’s agent immediately. Do not return damaged equipment to the factory before the carrier’s agent has authorized repairs.

If the instrument fails to respond as described in this document and the cause cannot be determined, do not use the instrument. Contact qualified

ALARIS Medical Systems

service personnel.

If it is necessary to return the instrument for service, obtain a return authorization number prior to shipment. Carefully package the instrument (preferably in the original packaging), reference the return authorization information, and return it to the appropriate service or distribution center.

ALARIS Medical

Systems does not assume any responsibility for loss of, or damage to, returned instruments while in transit.

Service Information

During servicing, an instrument’s configuration settings might be reset to the factory defaults. Qualified hospital/facility personnel are responsible for checking in the instrument and ensuring the current hospital-approved data set is loaded.

WARNING

Inspection Requirements

Failure to perform these inspections may result in improper instrument operation.

WARNING

Regular and preventive maintenance inspections should only be performed by qualified service personnel.

CAUTION

Technical support, service information, applications, and manuals may be obtained by contacting an

ALARIS Medical

Systems representative.

When submitting any request for service, include:

• Model number

• a description of difficulty experienced

• instrument settings

• administration set/lot number

• solution(s) used

• message displayed at time of difficulty

MAINTENANCE

Programming Module, 8000 Series

Directions for Use

Service Information

(Continued)

Technical Support

ALARIS Medical Systems, Inc., (hereinafter referred to as “ALARIS Medical Systems”) warrants

that:

A. Each new

ALARIS Medical Systems

Medley™Programming Module is free from defects in material and workmanship under normal use and service for a period of one (1) year from the date of delivery by

ALARIS Medical Systems to the original purchaser.

B. The battery and each new accessory is free from defects in material and workmanship under

normal use and service for a period of ninety (

) days from the date of delivery by ALARIS

Medical Systems to the original purchaser.

If any product requires service during the applicable warranty period, the purchaser should communicate directly with the relevant account representative to determine the appropriate repair facility. Except as provided otherwise in this warranty, repair or replacement will be carried out at

ALARIS

Medical Systems’ expense. The product requiring service should be returned promptly, properly packaged and postage prepaid by purchaser. Loss or damage in return shipment to the repair facility shall be at purchaser’s risk.

In no event shall

ALARIS

Medical Systems be liable for any incidental, indirect or consequential

damages in connection with the purchase or use of any

ALARIS Medical Systems

Product. This warranty shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and

ALARIS Medical Systems shall not be responsible for, any loss or damage arising in connection

with the purchase or use of any

ALARIS Medical Systems

Product which has been:

(a) repaired by anyone other than an authorized

ALARIS

Medical Systems Service Representative;

(b) altered in any way so as to affect, in

ALARIS Medical Systems’ judgment, the product’s stability

or reliability;

number altered, effaced or removed;

(d) improperly maintained or used in any manner other than in accordance with the written

instructions furnished by

ALARIS Medical Systems.

This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of

ALARIS Medical Systems, and ALARIS Medical Systems does not give or grant, directly

or indirectly, the authority to any representative or other person to assume on behalf of

ALARIS

Medical Systems any other liability in connection with the sale or use of ALARIS Medical Systems

Products.

ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

See packing inserts for international warranty, if applicable.

40 MAINTENANCE

Programming Module, 8000 Series

Directions for Use

WARRANTY

ALARIS®, ALARIS Medical Systems®, Flo-Stop®, Guardrails®, and Medley™are trademarks and registered trademarks of ALARIS Medical Systems, Inc.

All other trademarks belong to their respective owners.

Patents, Breveté, Brevets, Brevetti, Ned. Octrooi, Patente, Patenten, , :

US – 4,690,673; 4,764,166; 5,096,385; 5,165,873; 5,601,445; 5,713,856; 5,781,442; 5,800,387; 5,836,910; 5,941,846. AT – 0,225,158. AU – 596,552; 634,811; 693,662; 703,178; 719,254; 728,366; 730,203. BE – 0,225,158. CA – 1,258,212; 1,296,092; 2,026,518; 2,029,267. CH – +0,225,158. DE – P3686558.3; P690244923; 0,422,855. FR – 0,225,158; 0,422,855; 0,431,310. HK – 1006006. IT – 0,225,158. JP – 1,816,872; 2,594,604. NL – 0,225,158. SE – 0,225,158. TW – NI–107963. UK – 0,225,158; 0,422,855; 0,431,310. Other Patents

Pending

ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, California 92121 U.S.A.

Mail: P.O. Box 85335 San Diego, California 92186-5335 U.S.A.

Programming Module, 8000 Series

Directions for Use

ALARIS Medical Systems Medley User Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

INTRODUCTION

About the System

Symbols

GETTING STARTED

Front/Side View

Rear View

Installation

Adding Module(s) While System is Powered On

Detaching Module(s)

Displays

Main Display

Start-Up

Powering On System

Adjusting Display Contrast

Responding to Maintenance Reminder

Entering Patient ID

Modifying Patient ID

Setting Up Time of Day

Adjusting Audio Volume

Reviewing System Configuration

Reviewing Serial Number

Reviewing Software Version

Powering Off

Powering Off System

Powering Off Module

Locking/Unlocking Tamper Resist

Computer Link

ALARMS, ERRORS, MESSAGES

Definitions

Audio Characteristics

Alarms

Errors

Messages

MAINTENANCE

Specifications

Storage

Battery Charge

Battery Care

Cleaning

Service Information

Inspection Requirements

Technical Support

WARRANTY