Alaris PC Unit 8000 User manual

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Page 1

Directions for Use

Alaris® System

(with PC Unit, Model 8000)

Supports Guardrails® Suite MX with Guardrails® Point-Of-Care software and v9 Operating System software.

February 2007

ONI

%SpO

PULSE (BPM)

CHANNEL

SELECT

MONITOR

CHANNEL

OFF

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

SILENCE

OPTIONS

CLEAR

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

SYSTEM

ENTER

CANCEL

OFF

RESTART

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Alaris® Products

Page 2

Each of the Alaris® product-specific Sections has its own table of contents. General Contact Information

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

PC Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Pump and Syringe Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

PCA Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

SpO2 Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

EtCO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Auto-ID Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Nurse Call Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Communications Interface Board Accessory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Appendix

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Service Information

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Regulations and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

Compliance

Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-14

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Order Numbers:

Alaris® System (with v9 Model 8000) DFU

Page 3

Cardinal Health

Alaris

10221 Wateridge Circle

Products

San Diego, California cardinal.com/alaris

Maintenance and service information support; troubleshooting.

General Contact Information

92121

Customer Advocacy - North America

Clinical and technical feedback.

Phone: 800.854.7128, Ext. 7812

E-Mail: CustomerFeedback@cardinal.com

Technical Support - North America

United States - Phone:

858.458.6003

800.854.7128, Ext. 6003

Within Canada: 800.387.8309 From United States: 800.908.9918

Canada - Phone:

Customer Care - North America

Instrument return, service assistance, and order placement.

United States - Phone: 800.482.4822 Canada - Phone: 800.387.8309

Alaris® System (with v9 Model 8000) DFU

Page 4

Introduction

The Alaris® PC unit Section of this Directions for Use ("DFU") provides procedures and information applicable to the Alaris System and the PC Unit. Each of the other major Sections provides product-specific procedures and information.

The Alaris

System is a modular system intended for adult, pediatric and neonatal care in today’s growing professional healthcare environment. It consists of the PC Unit, the

Guardrails

Suite MX, and up to 4 detachable infusion and/or monitoring modules (channels). The Auto-ID Module can be included as a fifth module.

Guardrails

Suite MX for the Alaris® System brings a new level of medication error prevention to the point of patient

care. The Guardrails

Suite MX features medication dosing, concentration delivery rate and optional initial programming guidelines for up to

15 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 Clinical Advisories provide visual messages. Dosing limits for each

Guardrails

drug entry may be a Hard Limit that cannot be overridden during infusion programming and/or a Soft Limit that can be overridden, based on clinical requirements.

WARNING

Read all instructions before using

the Alaris

System.

CAUTION

nly

A Data Set is developed and approved by the facility’s own

multi-disciplinary team using the Editor Software, the authoring tool. A Data Set is then transferred to the Alaris

based

System by qualified personnel. The approved Data Sets are maintained by the Editor Software for future updates and reference.

Information about an Alert that occurs during use is stored within the PC Unit, and can be accessed using the CQI Reporter.

Documentation provided with Alaris

System products may reference product not present in your facility or not yet available for sale in your area.



A superscript number (for example, information provided as a

NOTE at the end of the procedure.

) identifies additional

Alaris® System (with v9 Model 8000) DFU

Page 5

Introduction (Continued)

WARNINGS AND CAUTIONS:

Product-specific warnings and cautions, covered in the applicable Sections of this DFU safely and effectively use the Alaris

, provide information needed to

System. A

DANGER

is an alert to an imminent hazard which could result in serious personal injury and/or product damage if proper procedures are not followed.

WARNING

is an alert to a potential hazard which could result in serious personal injury and/or product damage if proper procedures are not followed.

CAUTION

is an alert to a potential hazard which could result in minor personal injury and/or product damage if proper procedures are not followed.

DEFINED TERMS:

The following table identifies the defined terms used throughout this document for certain products and product features.

Product / Feature Defined Term

Alaris® Auto-ID module Auto-ID Module Alaris® EtCO2 module EtCO2 Module Alaris® Mobile Systems Manager Mobile Systems Manager Alaris® PCA module PCA Module Alaris® PC point-of-care unit PC Unit Alaris® Pump module Pump Module Alaris® SpO2 module SpO2 Module Alaris® Syringe module Syringe Module Alaris® System Maintenance System Maintenance Alaris® Systems Manager Systems Manager Guardrails® alert Alert Guardrails® clinical advisory Clinical Advisory Guardrails® CQI Reporter CQI Reporter Guardrails® data set Data Set Guardrails® drug library Drug Library Guardrails® Editor Editor Software Guardrails® hard limit Hard Limit Guardrails® IV fluid IV Fluid Guardrails® limit Limit Guardrails® PCA pause protocol PCA Pause Protocol Guardrails® soft limit Soft Limit SmartSite® needle-free valve Needle-Free Valve SmartSite® positive bolus needle-free valve Needle-Free Valve

Alaris® System (with v9 Model 8000) DFU

iii

Page 6

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 Alaris

System in use:

1. Perform check-in procedure using System Maintenance

software.

2. Verify whether or not Profiles feature has been enabled

(see PC Unit Section, "System Options", "System Configurations").

NOTE:

 To enable the Profiles feature, a hospital-defined best-practice

Data Set must be uploaded to the PC Unit.



Alaris® System (with v9 Model 8000) DFU

Page 7

Alaris® PC Unit

Model 8000

SILENCE

OPTIONS

CLEAR

SYSTEM

ENTER

CANCEL

Alaris® System (with v9 Model 8000) DFU, Section

Page 8

Page 9

Table of Contents

GETTING STARTED

INTRODUCTION................................................................................................................................................................................................. 1-1

GENERAL SETUP AND OPERATION

ATTACHING AND DETACHING MODULES .......................................................................................................................................... 1-3

Attaching Module(s) ................................................................................................................................................................................ 1-3

Detaching Module(s) ............................................................................................................................................................................... 1-4

Adding Module(s) While System is Powered On

START -UP

.............................................................................................................................................................................................................. 1-5

Powering On System .............................................................................................................................................................................. 1-5

Responding to Maintenance Reminder .......................................................................................................................................... 1-6

Adjusting Display Contrast

................................................................................................................................................................... 1-6

Selecting New Patient and Profile Options ................................................................................................................................... 1-7

Adjusting Audio Volume

........................................................................................................................................................................ 1-9

Locking/Unlocking Tamper Resist .................................................................................................................................................... 1-10

POWER OFF SYSTEM .................................................................................................................................................................................... 1-11

SYSTEM OPTIONS

........................................................................................................................................................................................... 1-11

Display Contrast ....................................................................................................................................................................................... 1-11

Patient ID ..................................................................................................................................................................................................... 1-12

Clinician ID .................................................................................................................................................................................................. 1-14

Power Down All Channels

Anesthesia Mode

Battery Runtime

..................................................................................................................................................................................... 1-16

........................................................................................................................................................................................ 1-19

System Configurations

.................................................................................................................................................................... 1-15

.......................................................................................................................................................................... 1-19

Serial Numbers ......................................................................................................................................................................................... 1-21

Software Versions ................................................................................................................................................................................... 1-22

Time of Day ................................................................................................................................................................................................ 1-23

Network Status ......................................................................................................................................................................................... 1-24

Wireless Connection .............................................................................................................................................................................. 1-26

Data Set Status ......................................................................................................................................................................................... 1-27

Maintenance Due ..................................................................................................................................................................................... 1-28

........................................................................................................................ 1-4

GENERAL INFORMATION

WARNINGS AND CAUTIONS .............................................................................................................................. ........................................ 1-31

General ......................................................................................................................................................................................................... 1-31

Electromagnetic Compatibility ............................................................................................................................................................ 1-32

FEATURES AND DISPLAYS ......................................................................................................................................................................... 1-33

Features and Definitions ....................................................................................................................................................................... 1-33

Operating Features, Controls, Indicators ...................................................................................................................................... 1-35

Displays ........................................................................................................................................................................................................ 1-37

SYSTEM CONFIGURABLE SETTINGS .................................................................................................................................................. 1-38

SPECIFICATIONS AND SYMBOLS ........................................................................................................................................................... 1-39

Specifications ............................................................................................................................................................................................ 1-39

Symbols ....................................................................................................................................................................................................... 1-40

Alaris® System (with v9 Model 8000) DFU

Table of Contents i

PC Unit Section

Page 10

TROUBLESHOOTING AND MAINTENANCE

GENERAL .............................................................................................................................................................................................................. 1-43

ALARM, ERRORS, MESSAGES

Definitions

Audio Characteristics

Alarms ........................................................................................................................................................................................................... 1-45

Errors............................................................................................................................................................................................................. 1-45

Messages .................................................................................................................................................................................................... 1-46

STORAGE

BATTERY CARE AND MAINTENANCE

Battery Type and Charging .................................................................................................................................................................. 1-47

Battery Charge .......................................................................................................................................................................................... 1-48

Battery Care

............................................................................................................................................................................................... 1-48

Battery Cautions and Disposal .......................................................................................................................................................... 1-48

INSPECTION REQUIREMENTS

................................................................................................................................................................. 1-43

............................................................................................................................................................................. 1-44

.................................................................................................................................................. 1-47

................................................................................................................................................................. 1-49

ii Table of Contents

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Page 11

Introduction

Getting Started

This Section of the DFU provides PC Unit (Model 8000) and

Alaris

System instructions and information. It is used in

conjunction with:

• PC Unit / Pump Module Technical Service Manual

• Product-specific sections of this

• System Maintenance software (and its instructions) for Alaris® System check-in, maintenance, and wireless configuration

DFU

The PC Unit is the core of the Alaris® System and provides a common user interface for programming infusions and monitoring, which helps to reduce complexity at the point of care.

Alarms, Errors, Messages: See "Troubleshooting and Maintenance" for specific PC Unit alarms, errors and messages.

Contraindications: None known. Electromagnetic Environment: See "Appendix" Section of

this DFU ("Regulations and Standards", "Compliance").

WARNING

Read all instructions, including

those for the attached module(s) and applicable accessories, before using

the Alaris

System.

CAUTION

nly

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Getting Started 1-1

Page 12

THIS PAGE

INTENTIONALLY

LEFT BLANK

1-2 Getting Started

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 13

General Setup and Operation

Attaching and Detaching Module(s)

Modules can be attached to either side of the PC 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 PC Unit or another module.

Attaching Module(s)

  

1. Position free module at a 45° angle, aligning IUI

connectors.

2. Rotate free module down against PC Unit or attached

module, until release latch snaps in place.

IUI Connectors

45°

WARNING

When properly secured/snapped, the release latch provides a very secure connection between modules. If not properly latched, a module can be dislodged during operation.

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 PC Unit and modules may prevent proper latching.

 The Alaris® System is designed to operate a maximum of 4

infusion or monitoring modules. Modules added in excess of

4 are recognized by the system. The Auto-ID Module can be

included as a fifth module. 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.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Release Latch

General Setup and Operation 1-3

Page 14

Attaching and Detaching Modules (Continued)

Detaching Module(s)

1. Ensure module(s) is powered off before detaching.

2. Push module release latch and then rotate module(s) up

and away from PC Unit or attached module (opposite to motion shown above) to disengage connectors.

• Alaris module identification (

• Appropriate module position(s) ( remaining module(s) appear on Main Display.

System reidentifies and shows appropriate

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

A, B or C) for

Adding Module(s) While System is Powered On

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, C or D)

illuminates. Modules are always labeled left to right, so if a module is added to left of other modules, all modules are reidentified. Module reidentification does

NOT interrupt or

affect infusion or monitoring on active modules.

• Module positions (

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 replacement module can be substituted.

A, B, C or D) appear on Main Display.

IUI connector, it may be used until a



1-4 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 15

Start-Up

Powering On System



1. Connect PC 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, C or D) displays on attached module(s).

• An Audio tone sounds.

• If PM Reminder option is enabled and scheduled preventive maintenance is due,

REMINDER screen appears.

MAINTENANCE

• At completion of system-on test, New Patient? screen appears.

NOTES:

 Previous infusion parameters are automatically cleared after

8 hours.

 If any of the following conditions are observed, the PC 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, 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.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-5

Page 16

Start-Up (Continued)

Responding to Maintenance Reminder

 

If the Preventive Maintenance (PM) Reminder option is enabled and the PC Unit or an attached module is due for preventive maintenance, a

MAINTENANCE REMINDER message appears

at power up.

1. Remove and, if needed, replace module requiring maintenance with a new module (see "Attaching and Detaching Modules").

2. If Alaris

System was powered off to replace PC Unit,

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

preventive maintenance:

Module A:

MAINTENANCE REMINDER

Module(s) due for routine

preventive maintenance:

YYYY-MM-DD

CONFIRM

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.

Adjusting Display Contrast

1. Press DISPLAY CONTRST soft key.

Midtown Hospital

NEW PATIENT ?

“Yes” Clears Previous Patient Data

>Select Yes or No

DISPLAY

CONTRST

Yes

1-6 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 17

Start-Up (Continued)

Adjusting Display Contrast (Continued)

2. To adjust display for optimum viewing, use Lighter/Darker soft keys.

3. To return to main screen, press CONFIRM soft key.

Selecting New Patient and Profile Options

The following procedures assume the Profiles feature is enabled.

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.



System Options

Display Contrast

Guardrails Suite MX (v8)

>Adjust Display to Desired Contrast

CONFIRM

Midtown Hospital

NEW PATIENT ?

“Yes” Clears Previous Patient Data

>Select Yes or No

DISPLAY

CONTRST

Lighter

Darker

Yes

2. Accept or change current 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.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Midtown Hospital Adult ICU

Adult ICU ?

“Yes” Confirms Same Profile

>Select Yes or No

Yes

General Setup and Operation 1-7

Page 18

Start-Up (Continued)

Selecting New Patient and Profile Options (Continued)

3. To select a profile, press corresponding left soft key.



4. To confirm profile selection, press CONFIRM soft key.

• Main screen appears.

NOTES:

 If the Profiles feature is disabled, the main menu appears.  To view additional choices, press

PAGE DOWN soft key.

Patient ID Entry Feature

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 (see "System Options").

Midtown Hospital Profiles

Adult ICU

Adult General Care

Neonatal

Peds ICU

Neonatal ICU

>Press CONFIRM

CONFIRM

1of2

PAGE DOWN

If Yes was selected to indicate programming for a new patient, perform one of following steps:

• If patient identifier is not required, press

CONFIRM or EXIT

soft key.

• To manually enter patient identifier, use numeric data entry

keys and/or alpha speed keys.

    

• To scan bar code on patient identification band, see

Auto-ID Module Section of this DFU.

1-8 General Setup and Operation

Patient ID Entry

________________

>Enter Patient ID and Press CONFIRM

CONFIRM

EXIT

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

A-E

F-J

K-O

P-T

U-Y

PAGE DOWN

Page 19

Start-Up (Continued)

Selecting New Patient and Profile Options (Continued)

Patient ID Entry Feature (Continued)

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

Adjusting Audio Volume

CANCEL key.

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, press Test soft key.

3. To return to PC Unit screen, press

MAIN SCREEN soft key.

• After 30 seconds without a key press, Main Display

appears.

Midtown Hospital Adult ICU

VTBI = 250.0 mL

VOLUME INFUSED

Audio Volume Adjust

AUDIO

ADJUST

Test

Softer

>Change Setting or Cancel

Louder

MAIN

SCREEN

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-9

Page 20

Start-Up (Continued)

Locking/Unlocking Tamper Resist

1. Initiate operation of applicable module(s).

2. Press and hold Tamper Resist Switch, on back of PC Unit,

3 to 4 seconds (see "General Information", "Features

for and Displays", "Operating Features, Controls, Indicators").

• An advisory tone (if Key Click Audio is enabled)

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 audio alarm. ♦ View volume(s) infused. ♦ View and test audio alarm setting. ♦ View selected parameters on attached modules.

Any other key press results 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

3 to 4 seconds.

• An advisory tone (if Key Click Audio is enabled) and

a three-second

PANEL UNLOCKED prompt on Main

Display confirm activation.

Midtown Hospital Adult ICU

VTBI = 250.0 mL

PANEL LOCKED

VOLUME INFUSED

Midtown Hospital Adult ICU

VTBI = 250.0 mL

AUDIO

ADJUST

1-10 General Setup and Operation

PANEL UNLOCKED

VOLUME INFUSED

Alaris

System (with v9 Model 8000) DFU

AUDIO

ADJUST

PC Unit Section

Page 21

Power Off System

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



1.5 seconds) and then release to initiate power

• During power off sequence, Main Display flashes

Powering Down.

• Once all attached modules are powered off, PC Unit

automatically powers down.

NOTE:

 To interrupt the power down sequence, quickly press any key

(except SYSTEM ON) on the PC Unit.

System Options

Display Contrast

Powering Down

1. Press OPTIONS key.

2. Press Display Contrast soft key.

3. Adjust display and return to main screen (see "Start-Up", "Adjusting Display Contrast" procedure).

SILENCE

OPTIONS

CLEAR

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

SYSTEM

ENTER

CANCEL

PAGE

DOWN

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-11

Page 22

Entering

1. Press OPTIONS key.

System Options (Continued)

Patient ID

2. Press Patient ID soft key.

3. Scan or manually enter patient identifier:

• To manually enter patient identifier, use numeric data

entry keys and/or alpha speed keys.

    

• To scan bar code on patient identification band, see

Auto-ID Module Section of this DFU.

4. To verify correct entry, press

CONFIRM soft key.

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

Patient ID Entry

123456789CD_____

>Enter Patient ID and Press CONFIRM

EXIT

CONFIRM

PAGE

DOWN

A-E

K-O

P-T

U-Y

PAGE

DOWN

F-J

1-1 2 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 23

System Options (Continued)

Patient ID (Continued)

Modifying

1. Press OPTIONS key.

2. Press Patient ID soft key.

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.

  

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

• New Patient ID Entry verification screen appears.

SILENCE

OPTIONS

CLEAR

Patient ID Entry

234567891EF_____

>Enter Patient ID and Press CONFIRM

EXIT

CONFIRM

ENTER

CANCEL

A-E

F-J

K-O

P-T

U-Y

PAGE

DOWN

SYSTEM

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-13

Page 24

Patient ID (Continued)

Modifying (Continued)

System Options (Continued)

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.

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.

Patient ID Entry

Patient ID 123456789CD will be changed to 234567891EF

Is this correct?

>Press Yes or No

Yes

Clinician ID

1. Press OPTIONS key.

2. Press Clinician ID soft key.

1-14 General Setup and Operation

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

PAG E

DOWN

Page 25

System Options (Continued)

Clinician ID (Continued)

3. Scan or manually enter clinician identifier:

• To manually enter clinician identifier, use numeric data

entry keys and/or alpha speed keys.

    

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

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 "

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.

Z" and special characters (hyphen,

Clinician ID Entry

CONFIRM

A-E

F-J

K-O

P-T

U-Y

PAGE

DOWN

123456789CD_____

>Enter Clinician ID and Press CONFIRM

EXIT

Power Down All Channels

1. Press OPTIONS key.

2. Press Power Down All Channels soft key.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

PAG E

DOWN

General Setup and Operation 1-15

Page 26

System Options (Continued)

Power Down All Channels (Continued)

3. Press Yes soft key.

• During power off sequence, Main Display flashes

POWERING DOWN.

Anesthesia Mode

When the Anesthesia Mode is enabled while a module is paused, the module remains in an indefinite pause until restarted.

When Anesthesia Mode is enabled:

• All limits are set to Soft.

• Dose checking mode is set to Smart.

• Key-press audio is turned off.

• Tamper Resist Mode (panel locked) is not available.

• Guardrails

Software as anesthesia only. All Guardrails profile can be viewed by pressing

drug list defaults to drugs designated by Editor

drugs in a

ALL DRUGS soft key.

System Options

Power Down All Channels?

>Press Yes or No

Yes

CAUTION

When the Alaris® System is set up for use in Anesthesia Mode, it is important to select the profile that corresponds with the care area the patient will be taken to when the Anesthesia Mode is discontinued.

This ensures that the Alaris

System will be in the correct profile following the use of the Anesthesia Mode.

• Bolus dose is automatically available for:

♦ Guardrails ♦ generic drug calculation setup

drugs that have bolus dose limits defined

• Anesthesia Mode, alternating with other required prompts, displays in prompt bar of Main Display.

• Callback audio for paused module is permanently silenced.

• Review of drug calculation setup page is omitted when restoring a stopped drug calculation.

• Clinical Advisories are not displayed.

• Auto-ID Module is not available.

1-16 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 27

Anesthesia Mode (Continued)

Enabling

1. Press OPTIONS key.

System Options (Continued)

2. Press Anesthesia Mode soft key.

3. Press Enable soft key.

4. Press

CONFIRM soft key.

System Options 1 of 3

Display Contrast

Patient ID

Clinician ID

Power Down All Channels

Anesthesia Mode

>Select an Option or EXIT

EXIT

System Options

Anesthesia Mode

Pump Module Air Detection = 75

microliters

>Select an Option or Press CONFIRM

CONFIRM

PAGE

DOWN

Enable

Disable

Change

Disabling

The Anesthesia Mode can be disabled, and normal operation resumed, using either of the following three methods:

• System Options menu.

• Disconnecting from

AC power.

• Connecting to AC power.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-1 7

Page 28

Anesthesia Mode (Continued)

Disabling (Continued)

From System Options Menu

System Options (Continued)

1. Press

OPTIONS key.

2. Press Anesthesia Mode soft key.

3. Press Disable soft key.

4. Press

CONFIRM soft key.

• Anesthesia Mode no longer appears on Main Display, indicating it has been disabled.

Connecting To AC Power

1. Connect system to

AC power.

2. To continue using Anesthesia Mode, press Yes soft key.

To discontinue Anesthesia Mode, press No soft key.

AC power cord was connected. Continue

>Select Yes or No

Yes

?ANESTHESIA MODE

Disconnecting from AC Power

1. Disconnect system from

AC.

• Anesthesia Mode is automatically disabled.

• All currently running infusions continue.

• A prompt appears as an alert that Anesthesia Mode has been discontinued.

2. Press

CONFIRM soft key.

1-18 General Setup and Operation

Anesthesia mode was when AC power disconnected. continue normal operation.

>Press CONFIRM

Alaris

System (with v9 Model 8000) DFU

discontinued

cord was

Press CONFIRM to

CONFIRM

PC Unit Section

Page 29

Battery Runtime

1. Press OPTIONS key.

System Options (Continued)

2. Press

PAGE DOWN soft key.

3. Press Battery Runtime soft key.

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

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or EXIT

PAGE UP

EXIT

PAGE

DOWN

System Options

Estimated battery runtime at current operating parameters

9.5

hours

>Press CANCEL or EXIT

EXIT

System Configurations

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key.

3. Press System Configurations soft key.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or EXIT

PAGE UP

EXIT

PAGE

DOWN

General Setup and Operation 1-19

Page 30

System Options (Continued)

System Configurations (Continued)

4. Press PC Unit soft key.

5. To review various system configuration settings, press

PAGE DOWN and PAGE UP soft keys.

 

System Configuration - Module

Factory Default:

Shared Infusion Settings

PC Unit

Pump Module

SPO2 Module

>Press CANCEL or EXIT

EXIT

System Config - PCU 1 of 3

Alarm audio:

Anesthesia Mode: Disabled

Battery meter:

Clock setup:

Limit Checking:

>Press CANCEL or EXIT

EXIT

Yes

PAGE

DOWN

Profile 1

Disabled

09:00

ALWAYS

PAGE

DOWN

System Config - PCU 2 of 3

Key click audio:

Max Pt. BSA:

Max Pt. weight:

Patient ID Entry:

Pending IV Orders:

>Press CANCEL or EXIT

PAGE

EXIT

Enabled

500 kg

Disabled

Enabled

DOWN

PAGE

1-20 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 31

System Options (Continued)

System Configurations (Continued)

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

NOTES:

 The Profiles option is listed only if it is disabled.  The Limit Checking (or Dose Checking), Max Pt. BSA,

and Pending IV orders options are listed only if the Profiles option is enabled and a valid Data Set is loaded.

Serial Numbers

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key.

3. Press Serial Numbers soft key.

• Serial numbers for PC Unit and all attached modules

display .



System Config - PCU 3 of 3

PM Reminder:

Tamper resist:

>Press CANCEL or EXIT

PAGE

EXIT

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

Disabled

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

NOTE:

 "nnnn-nnnnnnnn" in the illustrated display represents a serial

number.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

>Select an Option or EXIT

PAGE UP

EXIT

PAGE

DOWN

Serial Number Review

PC Unit:

Module A:

Module B:

Module C:

Module D:

>Press CANCEL or EXIT

nnnn-nnnnnnnn

EXIT

General Setup and Operation 1-21

Page 32

Software Versions

1. Press OPTIONS key.

System Options (Continued)

2. Press

PAGE DOWN soft key.

3. Press Software Versions soft key.

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

To return to main screen, press EXIT soft key.

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or EXIT

PAGE UP

EXIT

Software Rev. Review

PC Unit:

Module A:

Module B:

Module C:

Module D:

>Select an Option or EXIT

EXIT

PAGE

DOWN

View

5. To return to previous screen, press EXIT soft key.

NOTE:

 "nn.nn" in the illustrated display represents a software

version.

1-22 General Setup and Operation



Alaris

System (with v9 Model 8000) DFU

Software Rev. Review

Module Software: A

Main processor:

Main boot block:

Keyboard:

>Press CANCEL or EXIT

EXIT

nn.nn

PC Unit Section

Page 33

System Options (Continued)

Time of Day



1. Press OPTIONS key.

2. Press

PAGE DOWN soft key.

3. Press Time of Day soft key.

4. If time is correct, press CONFIRM soft key.

To change time, press Change Time soft key.

System Options 2 of 3

Battery Runtime

System Configurations

Serial Numbers

Software Versions

Time of Day

>Select an Option or EXIT

PAGE UP

EXIT

PAGE

DOWN

System Options

Time of Day

Current time:

09:00

Change

Time

5. Enter current Time of Day.

>CONFIRM Time-of-Day

CONFIRM

EXIT

System Options

Time of Day

Current time:

__:__

>Enter Current Time

EXIT

CONFIRM

Change

Time

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-23

Page 34

System Options (Continued)

Time of Day (Continued)



6. Press CONFIRM soft key.

NOTE:

 The format is a

24-hour clock (military time).

Network Status

This option is available only when the Communications Interface Board Accessory is installed and the PC Unit has been flashed to support wireless communications with Alaris Server or Mobile Systems Manager. The displayed status updates immediately when a status change takes place.

System Options

Time of Day

Current time:

14:30

>Press CONFIRM

EXIT

CONFIRM

Change

Time

1. Press

OPTIONS key.

2. Press PAGE DOWN soft key 2 times.

3. To view network status and wireless status information, press Network Status soft key.

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

>Select an Option or EXIT

EXIT

PAGE UP

1-24 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 35

System Options (Continued)

Network Status (Continued)

4. Enter password (can be found in System Maintenance software instructions).

• Information based on a wireless status of

DISASSOCIATED, SCANNING, IDENTIFYING, ASSOCIATING, or ASSOCIATED is displayed.

• If wireless status is

ASSOCIATED, wireless connectivity

link quality and signal strength is identified.

5. To view network connectivity information, press NET

STATUS

• A status of

soft key.

DISABLED, DISCONNECTED,

CONFIGURING, or CONNECTED is displayed.

System Options

Viewing Network Status is only to be used by qualified personnel.

*____

>Enter Password or EXIT

CONFIRM

EXIT

System Options

Wireless Status

ASSOCIATED

Status :

AM SWEPXXXXXXXX

SSID :

XXXXXXXXXXXXXXX

BSSID :

00:0A:B3:36:9F:88

Channel :

1 (2.142 Ghz)

Authentication :

Encryption:

Speed: 11 Mbps

>Press CANCEL to Exit

OPEN 40 bit WEP

Link Quality

Signal Strength

NET

STATUS

NET

ADDRESS

35% 75%

SERVER

STATUS

6. To view network address information, press

ADDRESS soft key.

NET

System Options

Network Status

Status : Uptime :

Bytes Sent:

Bytes Recv:

>Press CANCEL to Exit

WIRELESS

STATUS

CONNECTED 03:45:35

13, 890

1,200,150

NET

ADDRESS

SERVER

STATUS

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-25

Page 36

System Options (Continued)

Network Status (Continued)

7. To view server connectivity information, press SERVER

STATUS soft key.

• Information based on a status of

SEARCHING, VERIFYING, CONNECTING, or CONNECTED is displayed.

DISABLED,

System Options

Network Address

MAC Address:

DHCP Enabled :

IP Address: Subnet Mask: Gateway:

DNS Primary: DNS Secondary:

00:0A:B3:36:9F:88

YES

192.168.0.55

255.255.255.0

192.168.0.1

192.168.0.3

>Press CANCEL to Exit

NET

WIRELESS

STATUS

System Options

Server Status

Status: Uptime:

Server Address:

TCP Port:

Local Timeout: Server Timeout: Encryption: Bytes Sent: Bytes Received: Last Disconnect:

>Press CANCEL to Exit

WIRELESS

STATUS

CONNECTED 00:00:02

192.168.0.2

65535 3612 / 4000ms 20ms

AES 128-bit

1,103,470,776 94,300 UNKNOWN

Beacons Received

NET

ADDRESS

STATUS

NET

SERVER

STATUS

20%

Wireless Connection

1. Press

2. Press

OPTIONS key. PAGE DOWN soft key 2 times.

3. Press Wireless Connection soft key.

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

>Select an Option or EXIT

EXIT

PAGE UP

1-26 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 37

System Options (Continued)

Wireless Connection (Continued)

4. To disable wireless communication, press Disable soft key.

To enable wireless communication, press Enable soft key.

Data Set Status

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key 2 times.

WARNING

To comply with FAA regulations and prevent potential interference with aircraft communications, disable wireless communication when the

Alaris

System is used in an aircraft.

System Options

Wireless Connection

>Press ENABLE or DISABLE

Enable

Disable

3. To view Data Set status, press Data Set Status soft key.

-- Continued Next Page --

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

>Select an Option or EXIT

EXIT

PAGE UP

General Setup and Operation 1-27

Page 38

System Options (Continued)

ID: 83442BB Activated:

2005-09-18 08:45

Data Set Status (Continued)

• A status of Current, Pending, Transferring, or Not

Activated displays.

Maintenance Due

1. Press OPTIONS key.

2. Press

PAGE DOWN soft key 2 times.

3. Press Maintenance Due soft key.

System Options

Data Set Status

Current:

(none available)

ID: 83442BB Activated: 2005-09-18 08:45

Midtown Hospital

Pending:

Dataset ID: 83442BB Not Activated

>Press EXIT

EXIT

System Options 3 of 3

Network Status

Wireless Connection

Data Set Status

Maintenance Due Yes

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

-- Continued Next Page --

1-28 General Setup and Operation

>Select an Option or EXIT

EXIT

PAGE UP



Alaris

System (with v9 Model 8000) DFU

System Options

Maintenance Due Dates

Module(s) due for routine

preventative maintenance:

PC Unit:

Module A:

Module B:

Module C:

Module D:

>Press CANCEL or EXIT

YYYY-MM-DD

EXIT

PAGE

DOWN

PC Unit Section

Page 39

System Options (Continued)

Maintenance Due (Continued)

NOTE:

 PAGE DOWN soft key appears only if an Auto-ID Module is

attached.

System Options

Maintenance Due Dates

Module(s) due for routine

preventative maintenance:

Bar Code:

Bar Code: (Hand held)

>Press CANCEL or EXIT

PAGE UP

YYYY-MM-DD

EXIT

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Setup and Operation 1-29

Page 40

THIS PAGE

INTENTIONALLY

LEFT BLANK

1-30 General Setup and Operation

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 41

Warnings and Cautions

DANGER

Explosion risk if used in the presence of flammable

anesthetic agents or gasses.

General

WARNINGS

• Assess patient’s condition before silencing an alarm. Do not silence alarm if patient safety might be compromised.

• Before each use, verify the alarm limits are appropriate

for the patient.

• The Alaris

up. The PC Unit should beep, no errors should occur, and if a module is connected, all the Alaris PC Unit or module from use.

System performs a self check during power

System fails the self check, remove the failing

LED segments should flash. If

General Information

• When properly secured/snapped, the release latch

provides a very secure connection between modules. If not properly latched, a module can be dislodged during operation.

• Disconnect from main (

AC) and battery power when

performing maintenance.

• Electrical shock hazard. Do not open case. Refer to

qualified service personnel.

• To comply with

FAA regulations and prevent potential

interference with aircraft communications, disable

wireless communication when the Alaris

System is used in an aircraft (see "System Options", "Network Status").

• The Alaris

System is not intended to replace supervision

by medical personnel. The user must become thoroughly

familiar with the Alaris

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.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Information 1-31

Page 42

Warnings and Cautions (Continued)

General (Continued)

CAUTIONS

• Hyperbaric Chamber Operation:

♦ The Alaris

enriched environments.

♦ The Alaris

EtCO

malfunction alarms due to the hyperbaric chamber environment or unintentional key presses when used in a hyperbaric chamber.

♦ The healthcare facility's hyperbaric safety director is

responsible for all equipment used in the hyperbaric chamber environment.

• Should an instrument or accessory 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 Cardinal Health for authorization to return it for repair.

System is not certiﬁ ed for use in oxygen-

System, with the exclusion of the

Module, has been veriﬁ ed to operate with no

Electromagnetic Compatibility

WARNINGS

• Do not use the Alaris® System near Magnetic Resonance Imaging (

• Do not use the Alaris

MRI), including Stereotaxis technology.

System near Therapeutic Radiation

equipment, such as Linear Accelerators.

• Use of any accessory, transducer or cable other than

those specified may result in increased emissions or decreased Alaris

System immunity.

CAUTIONS

• The Alaris® System should not be used adjacent to or stacked with other equipment. If adjacent or stacked

use is necessary, monitor the Alaris

System to verify it is

operating normally in that setup.

• Portable and mobile

RF communications can affect

medical electrical equipment.

1-32 General Information

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 43

Warnings and Cautions (Continued)

Electromagnetic Compatibility (Continued)

CAUTIONS

• Interconnected data communications systems must be certified to

IEC 60601–1 (electromedical equipment).

• The Alaris professionals only. This is a medical system. In a domestic environment, this system may cause radio interference. Reorienting, relocating or shielding the system, or filtering the connection to the public mains network, are examples of steps that can be taken to reduce or eliminate interference.

• Medical electrical equipment needs special precautions

regarding

according to the "Appendix" Section of this DFU (see "Regulations and Standards", "Compliance").

IEC 60950 (data processing equipment) or

System is intended for use by healthcare

CISPR 11 Class B Group 2

EMC and needs to be installed and used

EMC information provided in the

• Nurse call systems must be certified to

UL 1069 (hospital

signaling and nurse call equipment) or comply with the requirements specified in

IEC 60601–1.

Features and Displays

Features and Definitions

See the product-specific Section of this DFU that applies to the attached module(s) for features and definitions specific to that module.

Clinician ID An optional alphanumeric

entered and displayed.

Data Set Created using Editor Software authoring tool and then transferred

to PC 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.

16-character clinician identifier that can be

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Information 1-33

Page 44

Features and Displays (Continued)

Features and Definitions (Continued)

Guardrails® Suite MX 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 visual and audio prompt if an out-of-limits entry is made.

Patient ID An optional alphanumeric

16-character patient identifier that can be

entered and displayed.

• When enabled,

• When disabled,

ID entry defaults to Startup screen.

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 can consist of following components:

• Instrument configuration settings.

• A Drug Library, which includes Drug names, standard concentrations, dosing units, duration limits, and optional associated Clinical Advisories for both continuous and bolus dose infusion.

• An

IV Fluid library, an optional library consisting of IV Fluids (for

example, TPN) and limits around rate of delivery.

• A Channel Label Library with text (alphanumeric) labels, which allows identification (on modules) that can be used to indicate 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 PC 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.

1-34 General Information

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 45

Features and Displays (Continued)

Operating Features, Controls, Indicators

IUI Connector, Left

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)

(not visible)

SYSTEM

IUI Connector, Right

System On Key: When

pressed, changes Alaris from Standby to Operating mode.

System

Up/Down Arrows: When

pressed, increases or decreases parameter with each key press or scrolls up and down when pressed and held.

Battery Indicator: When

illuminated, indicates Alaris® System is operating on battery power.

Power Indicator: When

illuminated, indicates Alaris® System is connected to an AC power source.

Wireless Network Indicator: When illuminated,

indicates Alaris® System is connected to Alaris® Server or Mobile Systems Manager. When blinking, indicates data transfer.

Clear Key: When

pressed, clears current selected parameter setting to "0".

Module Release Latch:

When pressed, allows module to be removed.

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

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Information 1-35

Page 46

Features and Displays (Continued)

Operating Features, Controls, Indicators (Continued)

IUI Connector, Right IUI Connector, Left

Power Cord Strap

Use this bolt to reorient Pole Clamp 90° for attachment to a bed rail instead of a pole.

Primary Audio Speaker

Connector Plug over RJ45 Communication Data Port

Tamper Resist Switch

Option Upgrade Panel

1-36 General Information

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 47

Features and Displays (Continued)

Displays

The displays illustrated throughout this document are for illustration purposes only. The display content varies, depending on configuration settings, hospital-defined Data Set uploaded using the Guardrails variables.

Main Display

Suite MX, and many other

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

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.

Midtown Hospital Adult ICU

VTBI = 250.0 mL

VOLUME INFUSED

Infusion Setup

RATE

VTBI

>Press START

PAUSE

40 mL/h

_250 mL

AUDIO

ADJUST

SECOND-

ARY

START

SYSTEM ON

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Information 1-37

Page 48

System Configurable Settings

If the configuration settings need to be changed from the Factory default settings, reference the applicable Technical Service Manual or contact Cardinal Health Technical Support, for technical, troubleshooting, and preventive maintenance information.

With the Profiles feature enabled, the settings are configured independently for each profile. A hospital-defined, bestpractice Data Set must be uploaded to enable the Profiles feature. Date and Time is a system setting and is the same in all profiles.

Feature

Alarm Audio Anesthesia Mode Battery Meter Clock Setup ( Dose Checking Key Click Audio Max Patient Weight Patient ID Entry PM Reminder

Preventive Maintenance)

( Profiles Tamper Resist

Date and Time)

Default Setting Options

Profile 1 Disabled Disabled

N/A

Always

Enabled

500 kg Disabled Enabled

Disabled Disabled

Profile 1, 2 or 3 Enabled - Disabled Enabled - Disabled Set date and time Always, Smart Enabled - Disabled

0.1 - 500 kg Enabled - Disabled Enabled - Disabled

Enabled - Disabled Enabled - Disabled

1-38 General Information

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 49

Specifications and Symbols

Specifications

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 operates as follows before a "BATTERY DISCHARGED" message occurs:

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

• 6 hours with 1 Pump Module infusing at 25 mL/h and 1 Auto-ID Module

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

• 3 hours with 4 Pump Modules infusing at 25 mL/h and 1 Auto-ID Module

• 4.5 hours with 1 active SpO2 Module

• 6 hours with 1 Syringe Module or PCA Module infusing at 5 mL/h

• 3 hours with 4 Syringe Modules, or 1 PCA Module and 3 Syringe Modules, infusing at 5 mL/h

• 4 hours with 1 active EtCO2 Module

Communication Data Port: RS-232 with an RJ45 connector. Dimensions: Electric Classification: Class 1, Internally Powered Equipment

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



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

least 6 months by internal backup lithium battery. Module-specific parameters are stored for 8 hours when system is turned off. After 8 hours of continuous off-time, or if a module is detached, module-specific trend data (if applicable) and modulespecific operating parameters are automatically purged. If a PCA, SpO2 or EtCO2 Module is detached and replaced with another PCA, SpO2 or EtCO2 Module, its module-specific trend data is purged.

Environmental Conditions: Operating Storage/Transport

Temperature Range: 41 - 104° F -4 - 140° F

(5 - 40° C) (-20 - 60° C)

Relative Humidity: 20 - 90% 5 - 85%

(Avoid prolonged exposure to relative humidity >85%)

Noncondensing Noncondensing

Atmospheric Pressure: 525 - 4560 mmHg 375 - 760 mmHg

(700 - 6080 hPa) (500 - 1013 hPa)

Equipment Orientation: To ensure proper operation, Alaris® System must remain in an upright position. Fluid Ingress Protection: IPX1, Drip Proof Mode of Operation: Continuous Power Requirements: 100 - 240V ~, 50/60 Hz, 150 VA MAX Shock Protection: Type CF, Defibrillator Proof Weight: 7.2 lbs

Alaris® System (with v9 Model 8000) DFU

PC Unit Section



General Information 1-39

Page 50

Specifications and Symbols (Continued)

Specifications (Continued)

NOTES:

 See the product-specific Section of this DFU for shock protection type and defibrillation-proof rating

information.

 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.

International: Use only cords that comply with IEC 60245, or IEC 60227, designation #53 and local electrical codes and/or regulations.

Symbols

See the product-specific Section of this DFU that applies to the attached module(s) for symbols specific to that module.

Silenced alarm. Alternating Current: Indicates device should be attached to alternating current source,

50/60 Hz only.

Battery power.

Caution: Reference 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.

Communications connector for

RS-232 attachment.

Consult operating instructions.

Type

CF defibrillation-proof equipment.

Electrostatic discharge (ESD).

1-40 General Information

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 51

Specifications and Symbols (Continued)

Symbols (Continued)

Fuse Replacement: Replace fuse only with same type and rating.

IPX1

MM-YYYY

nly

Protection against fluid ingress: Drip Proof

IUI Connector: Inter-Unit Interface connector used to establish power and

communications between PC 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 (

Caution: Federal (

SYSTEM ON"

RF) transmission.

U.S.A.) law restricts this device to sale by or on order of a physician.

Tamper Resist activate/deactivate switch.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

General Information 1-41

Page 52

THIS PAGE

INTENTIONALLY

LEFT BLANK

1-42 General Information

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 53

Troubleshoot ing and M aint enanc e

General

The Alaris® System Technical Service Manual is available from Cardinal Health. 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 System Maintenance software.

Alarms, Errors, Messages

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

Operating the system near equipment which radiates highenergy radio frequencies (such as, electrosurgical/cauterizing equipment, portable radios, cellular telephones) may cause false alarm conditions. If this happens, reposition the Alaris System away from the source of interference or turn off the system and manually regulate the flow with the clamp and/or monitor the vital parameters using an appropriate clinical alternative

Definitions

See the product-specific Section of this DFU that applies to the attached module(s) for alarm, error and message definitions specific to that module.

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

Alaris

System.

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

present. Immediate action is required.

Alarm Silence Alarms can be silenced for up to

120 seconds by pressing SILENCE

key. Alarm indicators remain on and, if applicable, alarm silence symbol (see monitoring module Section of this DFU) is displayed. Silence period can be ended by pressing

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Troubleshooting and Maintenance 1-43

CANCEL SILENCE soft key.

Page 54

Alarms, Errors, Messages (Continued)

Definitions (Continued)

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

Immediate action is required.

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

scheduled preventive maintenance is due/overdue for any part of

Alaris

Prompt An audio signal and/or a visual message appearing on bottom line of

Main Display or in Message Display. Audio signal may be silenced for

12 seconds by pressing SILENCE key.

Audio Characteristics

The Alaris® System provides various types of alert information. See the product-specific Section of this DFU that applies to the attached module(s) for audio characteristics specific to that module.

Type Sound Notes

System (PC Unit or attached module).

Advisory / Message

Alarm

Error (Hardware Detected)

Error (Software Detected)

Illegal Key Press

Key Click

Prompt

One short beep every 2 seconds

Choice of selectable in System Configuration

Pairs of long beeps

Two short beeps

One short beep

One short beep every

3 alarm audio profiles,

2 seconds

Variable volume; can be silenced

2 minutes.

for Variable volume; can be silenced

for 2 minutes. Fixed maximum decibel volume;

cannot be silenced. Fixed maximum decibel volume;

can be silenced for 2 minutes. Variable volume; cannot be

silenced. Fixed minimum volume; can be

silenced and disabled in System Configuration.

Variable volume; can be silenced.

1-44 Troubleshooting and Maintenance

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 55

Alarms, Errors, Messages (Continued)

Alarms

Alarm Meaning Response

Battery Discharged

Channel Disconnected

Very Low Battery <5 minutes to system shutdown

Error Meaning Response

Errors

Operation of all modules stopped due to insufficient battery charge.

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

Battery has of power at current power consumption rate before operation stops.

5 minutes or less

Connect AC power cord to power source (alarm silenced). To continue operation of paused modules, press affected module.

To silence alarm and clear message from screen, press

CONFIRM soft key. Reattach

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

Connect source (alarm silenced).

AC power cord to power

RESTART key on

Audio System Error

Channel Error

Defective Battery

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Main speaker failure.

Error detected. Operation stops on affected module.

Defective battery.

1. Visually check alarm status to determine whether or not an operational alarm also needs to be addressed (red Alarm Status Indicator lit).

2. Replace PC Unit with an operational instrument.

To silence alarm and continue operation of unaffected modules, press CONFIRM soft key. Replace module with an operational instrument.

To continue temporary operation, press SILENCE key. Replace PC Unit with an operational instrument.

Troubleshooting and Maintenance 1-45

Page 56

Alarms, Errors, Messages (Continued)

Errors (Continued)

Error Meaning Response

Hardware Detected Error

Missing Battery

Power Supply Error

System Error

Message Meaning Response

Battery Run Time = X.X hours

Messages

Error detected on PC Unit. Operation stops on all modules.

Battery not present or not connected.

Power supply system malfunction.

Error detected on PC Unit. Operation continues on all attached modules.

AC power cord is disconnected

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

Replace PC Unit with an operational instrument.

To continue temporary operation, press SILENCE key. Replace PC Unit with an operational instrument.

Disconnect AC power immediately. To continue operation under battery power, press SILENCE key. Replace PC Unit with an operational instrument.

To continue temporary operation, press SILENCE key. Replace PC Unit with an operational instrument.

Connect AC power cord to power source as soon as possible.

Low Battery

Panel Locked

Panel Unlocked Powering Down

1-46 Troubleshooting and Maintenance

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

Tamper Resist feature is active and key was pressed.

Tamper Resist feature deactivated. Last module powering off. System

shuts off in indicated number of seconds.

Alaris

Connect AC power cord to power source (alarm silenced).

If appropriate, deactivate Tamper Resist feature using Tamper Resist Control on back of PC Unit.

None. Press any key, except SYSTEM

key, to cancel power down

sequence.

System (with v9 Model 8000) DFU

PC Unit Section

Page 57

Alarms, Errors, Messages (Continued)

Messages (Continued)

Message Meaning Response

Replace Battery Occurs at System On. Battery has

less than 50% of original capacity.

Storage

Plug the PC Unit into an AC outlet during storage to ensure a fully charged battery. The

AC indicator light ( ) is on when the

PC Unit is plugged in.

Battery Care and Maintenance

Battery Type and Charging

The PC Unit is equipped with a 12 volt, 4000 mAh nickel metal hydride battery. The battery is charging whenever the instrument is plugged into an 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 has the longest life if the instrument is plugged in and battery use is infrequent. Frequent use of battery power and insufficient battery charge cycles significantly decrease the life of the battery.

AC receptacle. The life

To continue normal operation with reduced battery capacity, press CONFIRM soft key. Replace PC Unit with an operational instrument.

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.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Troubleshooting and Maintenance 1-47

Page 58

Battery Care and Maintenance (Continued)

Battery Charge

• The PC Unit is shipped with the battery in a discharged condition.

• Before the PC Unit is released for use, it should be plugged into a hospital grade at least

8 hours. This ensures proper battery operation

when the Alaris

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

AC power source while operating the instrument.

AC outlet and the battery charged for

System is first set up for patient use.

Battery Care

The battery capacity should be checked at least once every

6 months. Reference the Alaris

System Technical Service

Manual for test and replacement procedures. If the PC Unit is to be stored at temperatures in excess of

30° C) for 1 or more months, the battery should be removed

( and placed in an environment of

If the batteries are to be stored for more than

50 - 86° F (10 - 30° C).

1 year, they

86° F

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

1 or more months, it will not have full capacity due to

deactivation of reactants. Restore such batteries to original performance by repeating

1 or 2 cycles of fully charging and fully discharging.

Some temporary reduction in capacity might become apparent if the battery is partially discharged repeatedly. Doing

2 cycles of full discharge and full charge can restore full

performance.

Battery Cautions and Disposal

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

1-48 Troubleshooting and Maintenance

CAUTION

Do not open, incinerate or short

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

Alaris

System (with v9 Model 8000) DFU

PC Unit Section

Page 59

Inspection Requirements

To ensure the Alaris® System remains in good operating condition, both regular and prev entive maintenance inspections are required. Reference the System Maintenance software 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

WARNING

Failure to perform these

inspections may result in improper instrument operation.

CAUTION

Regular and preventive maintenance inspections should

only be performed by qualified service personnel.

Alaris® System (with v9 Model 8000) DFU

PC Unit Section

Troubleshooting and Maintenance 1-49

Page 60

Page 61

Alaris® Pump Module, Model 8100

Alaris® Syringe Module, Model 8110

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Alaris® System (with v9 Model 8000) DFU, Section

Page 62

Page 63

Table of Contents

GETTING STARTED

PREPARING ADMINISTRATION SET (PUMP MODULE)

.............................................................................................................. 2-3

Loading ......................................................................................................................................................................................................... 2-3

Removing .................................................................................................................................................................................................... 2-5

Priming ......................................................................................................................................................................................................... 2-5

PREPARING SYRINGE AND ADMINISTRATION SET (SYRINGE MODULE)

..................................................................... 2-6

Priming - Using Options Menu ........................................................................................................................................................... 2-11

Priming - Manual ...................................................................................................................................................................................... 2-17

PROGRAMMING

PRIMARY INFUSION - WITH GUARDRAILS® SUITE MX PROTECTION .............................................................................. 2-21

Continuous Infusion

Bolus Dose ................................................................................................................................................................................................. 2-30

Intermittent Infusion ................................................................................................................................................................................ 2-35

IV Fluid Infusion

SECONDARY INFUSION - WITH GUARDRAILS® SUITE MX PROTECTION (PUMP MODULE) ............................... 2-44

Introduction ................................................................................................................................................................................................. 2-44

Setup ............................................................................................................................................................................................................. 2-45

Infusion

Stopping Secondary and Returning to Primary

INFUSION - NO GUARDRAILS

Basic Infusion

Promoting Basic Infusion to Guardrails® Suite MX Protection Infusion ........................................................................... 2-52

Continuous Infusion - Drug Calculation ......................................................................................................................................... 2-52

SECONDARY INFUSION - NO GUARDRAILS® SUITE MX PROTECTION (PUMP MODULE) .................................... 2-55

Introduction and Setup .......................................................................................................................................................................... 2-55

Infusion ......................................................................................................................................................................................................... 2-55

Stopping Secondary and Returning to Primary .......................................................................................................................... 2-56

PAUSING, CHANGING, RESTARTING INFUSION ............................................................................................................................ 2-57

Pausing and Restarting Infusion ....................................................................................................................................................... 2-57

Changing Rate or VTBI During Infusion ........................................................................................................................................ 2-57

Restoring Infusion .................................................................................................................................................................................... 2-58

VIEWING AND CLEARING VOLUME INFUSED ................................................................................................................................. 2-58

CHANNEL LABELS ........................................................................................................................................................................................... 2-60

Selecting ...................................................................................................................................................................................................... 2-60

ANESTHESIA MODE ....................................................................................................................................................................................... 2-62

DELAY OPTIONS ............................................................................................................................................................................................... 2-63

Delaying Infusion...................................................................................................................................................................................... 2-63

Scheduling a Callback ........................................................................................................................................................................... 2-66

Pausing Infusion ....................................................................................................................................................................................... 2-67

MULTIDOSE MODE .............................................................................................................................. ............................................................ 2-68

Volume/Duration Enabled .................................................................................................................................................................... 2-70

Volume/Duration Disabled ................................................................................................................................................................... 2-71

SELECTING PRESSURE LIMIT .................................................................................................................................................................. 2-73

Pump Module ............................................................................................................................................................................................. 2-73

Syringe Module ......................................................................................................................................................................................... 2-74

................................................................................................................................................................................ 2-23

........................................................................................................................................................................................ 2-39

SUITE MX PROTECTION .......................................................................................................... 2-50

............................................................................................................................................................................................ 2-51

.......................................................................................................................... 2-49

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Table of Contents i

Page 64

GENERAL SETUP AND OPERATION

SYSTEM START-UP / SETUP ...................................................................................................................................................................... 2-77

Setting Up for Gravity Infusion (Pump Module)

Changing Solution Container (Pump Module)

Changing Syringe During Infusion (Syringe Module)

.......................................................................................................................... 2-77

............................................................................................................................. 2-77

............................................................................................................... 2-78

GENERAL INFORMATION

WARNINGS AND CAUTIONS .............................................................................................................................. ........................................ 2-79

Administration Sets

Epidural Administration

Guardrails® Suite MX ............................................................................................................................................................................. 2-82

ADMINISTRATION SET / SYRINGE INFORMATION ....................................................................................................................... 2-82

SmartSite

Infusion Set (Pump Module) ........................................................................................................................................ 2-83

Safety Clamp Fitment (Pump Module) ............................................................................................................................................ 2-84

Compatible Syringes (Syringe Module)

FEATURES AND DISPLAYS ......................................................................................................................................................................... 2-86

Features and Definitions ....................................................................................................................................................................... 2-86

Operating Features, Controls, Indicators

DRUG CALCULATION DEFINITIONS AND FORMULAS ............................................................................................................... 2-97

CONFIGURABLE SETTINGS ...................................................................................................................................................................... 2-98

Shared Infusion Pump Module Syringe Module

SPECIFICATIONS

SYMBOLS .............................................................................................................................................................................................................. 2-107

Pump and Syringe Modules ................................................................................................................................................................ 2-107

TRUMPET AND START-UP CURVES ...................................................................................................................................................... 2-108

Graphs .......................................................................................................................................................................................................... 2-111

................................................................................................................................................................................. 2-79

......................................................................................................................................................................... 2-81

......................................................................................................................................... 2-85

...................................................................................................................................... 2-93

......................................................................................................................................................................................... 2-98

............................................................................................................................................................................................. 2-99

......................................................................................................................................................................................... 2-100

.............................................................................................................................................................................................. 2-101

TROUBLESHOOTING AND MAINTENANCE

ALARMS, ERRORS, MESSAGES .............................................................................................................................................................. 2-115

Definitions ................................................................................................................................................................................................... 2-116

Audio Characteristics ............................................................................................................................................................................. 2-116

Possible End of Infusion Messages and Alerts .......................................................................................................................... 2-124

INSPECTION REQUIREMENTS ................................................................................................................................................................. 2-124

ii Table of Contents

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 65

Introduction

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Getting Started

This Section of the DFU provides Pump Module (Model 8100) and Syringe Module (Model

8110) instructions and information.

It is used in conjunction with:

• Alaris® product administration set instructions

• Drug product labeling

• PC Unit Section of this DFU

•

Pump Module Set Compatibility Card

• Pump Module Technical Service Manual

• Syringe Module Set Compatibility Card

• Syringe Module Technical Service Manual

• System Maintenance software (and its instructions) for Alaris

System check-in, maintenance, and wireless configuration

The Pump and Syringe Modules are intended for facilities that utilize infusion and/or syringe pumps for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (

IV), intra-arterial (IA),

subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump and Syringe Modules are indicated for use on adults, pediatrics, and neonates. Up to four (4) Pump and/or

Syringe Modules can be connected to the Alaris

System.

WARNING

Read all instructions, for both

the infusion modules and PC Unit,

before using the Alaris

System.

CAUTION

nly

If a procedure/information applies to a specific module, the following identifiers indicate the applicable module.

A N

RATE(mL/h)

CHANNEL SELECT

Pump Module :

PAUSE

CHANNEL OFF

RESTART

Syringe Module:

Administration Sets / Syringes: See "General Information" for specific "Administration Set / Syringe Information".

Alarms, Errors, Messages: See "Troubleshooting and Maintenance" for module-specific alarms, errors and messages.

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Getting Started 2-1

Page 66

Introduction (Continued)

Contraindications: None known. Electromagnetic Environment: See "Appendix" Section of

this DFU ("Regulations and Standards", "Compliance").

2-2 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 67

Preparing Administration Set (Pump Module)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

For instructions on how to go from checking in a Pump Module to preparing it for an infusion setup, see "General Setup and Operation".

1. If a new set is being loaded, prime set (see "Priming" procedure).

2. Open Pump Module door.

3. Load administration set, as follows: a. Hold upper fitment above fitment

recess and lower into recess.

b. Ensure tubing is not twisted.

WARNINGS

• To prevent a potential free-flow condition, ensure no extraneous

object (for example, bedding, tubing, glove) is enclosed or caught in the Pump Module door.

• Administration Sets:

♦ Use only Pump Module/

Gemini Infusion System

administration sets. The use

of any other set may cause improper instrument operation, resulting in an inaccurate fluid delivery or other potential hazard. For a list of compatible sets, reference the Set Compatibility Card (provided separately).

♦ Discard if packaging is not

intact or protector caps are unattached.

CAUTIONS

• Before operating instrument, verify that administration set is

free from kinks and installed

correctly in instrument.

• Insert upper fitment before installing safety clamp* fitment.

• When reloading an administration set, leave the

safety clamp* fitment in the closed position (see "General Information", "Safety Clamp Fitment").

* "Safety clamp" is referred to on

the device as "Flo-Stop".

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Getting Started 2-3

Page 68

Preparing Administration Set (Pump Module) (Continued)

Loading (Continued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

c. Press safety clamp fitment into recess below

mechanism.



d. Using a finger tip, firmly push tubing toward back of

Air-in-Line (

AIL) Detector.

4. Close door and latch, as follows: a. Close door and hold in a closed

position by grasping door and instrument case with one hand.

b. Gently lower latch.

• Safety clamp device is automatically disengaged.



CAUTION

To reduce the potential for nuisance

AIL alarms, ensure tubing is fully

inserted in

AIL Detector.

Safety Clamp Fitment



Push tubing toward

back of AIL Detector.

WARNINGS

• Do not touch the administration set while closing the door. Failure to follow this instruction may result in infusion rate inaccuracy.

• To prevent a potential free-flow condition, ensure no extraneous object (for example, bedding, tubing, glove) is enclosed or caught in the Pump Module door.

5. Open roller clamp.

6. Verify no fluid is flowing through drip chamber.

NOTE:

 "Safety clamp" is referred to on the device as "Flo-Stop".

2-4 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 69

Preparing Administration Set (Pump Module) (Continued)

Removing

1. Close roller clamp.

2. Open Pump Module door.

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

• Set’s safety clamp fitment automatically closes to prevent accidental free-flow.



3. Remove set, as follows: a. Gently pull tubing below Air-in-Line Detector forward

and out.

b. Lift upper fitment from upper fitment receptacle.

4. If set is being removed to begin a gravity flow: a. Depress blue ridged release tab on upper side of

safety clamp device.



b. Slide white slide clamp into blue fitment (open

position).

White Slide Clamp

(shown in closed position)

c. Adjust flow rate using set’s roller clamp.

NOTE:

 "Safety clamp" is referred to on the device as "Flo-Stop".

Priming

1. Prepare primary solution container in accordance with manufacturer’s directions for use.

2. Open administration set package, remove set, and close roller clamp. (Reference set’s directions for use.)

3. Insert administration set spike into prepared fluid container, following accepted hospital/facility procedure, and hang container

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

20 inches above Pump Module.

Getting Started 2-5

Page 70

Preparing Administration Set (Pump Module) (Continued)

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Priming (Continued)

4. Fill drip chamber to 2/3 full.

5. If container requires venting, open vent cap on administration set spike.

6. To prime tubing and clear air from injection sites and tubing fitments, slowly open roller clamp.

7. When priming is complete, close roller clamp.

8. Verify no fluid flow.

Preparing Syringe and Administration Set (Syringe Module)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

To decrease start-up delays when infusing at a rate less than

1.0 mL/h, the following actions are recommended:

• Enable Fast Start (with Data Set development of System

Configuration per profile).

• Use smallest syringe size possible (for example, if infusing

7.2 mL of fluid, use a 10 mL syringe).

• Prime Syringe Module as well as administration set (see

"Priming - Using Options Menu").

For instructions on how to go from checking in a Syringe Module to preparing it for an infusion setup, including how to change a syringe during infusion, see "General Setup and Operation".

1. Prepare syringe (see "General Information", "Compatible Syringes") in accordance with manufacturer’s directions for use.

2. Prepare administration set (reference Set Compatibility Card, provided separately) in accordance with manufacturer’s directions for use.

3. Attach upper fitting of administration set to syringe tip.

WARNING

Use only standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps. The use of any other syringe or administration set may cause improper instrument operation, resulting in inaccurate fluid delivery or pressure sensing, or other potential hazards. For a list of compatible syringes, see "General Information", "Compatible Syringes". For a list of compatible administration sets, reference the Set Compatibility Card (provided separately).

2-6 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 71

Preparing Syringe and Administration Set (Syringe Module) (Continued)

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

WARNINGS

• Before loading the syringe, check it for damage or defects.

• Ensure syringe barrel, flange, and plunger are installed and secured correctly. Failure to install syringe correctly can result in uncontrolled fluid flow to the patient, and may cause serious injury or death.

• Before loading or unloading the syringe, always turn off fluid flow to the patient, using the tubing clamp or stopcock. Uncontrolled fluid flow can occur when the administration set is not clamped or turned off, and may cause serious injury or death.

CAUTION

When initially loading the syringe,

allow for the volume of fluid contained in the administration set and retained in the syringe at the end of an infusion, as this "dead space" will not be infused.

1. Ensure instrument is as close to level of patient as possible (patient should be in line with key).

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

CHANNEL SELECT

RATE (mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Align with Patient

Getting Started 2-7

Page 72

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Loading (Continued)

2. Open syringe barrel clamp. a. Pull syringe barrel clamp out and hold. b. Rotate clamp to left (clockwise or counter clockwise)

until it clears syringe chamber.

c. Gently release clamp.

3. Raise drive head to its fully extended position. a. Twist gripper control clockwise and hold in position.



b. While holding gripper control in open position, raise

drive head to full extension.

c. Gently release gripper control.

4. Insert syringe (from front of instrument) by sliding flat edge of syringe barrel flange between barrel flange grippers.

RATE (mL/h)

CHANNEL

SELECT

Syringe Barrel Clamp Open

Drive Head Fully Extended

Gripper Control / Drive Head Release in Open Position

Plunger Grippers Open

2-8 Getting Started

RATE(mL/h)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

Alaris® System (with v9 Model 8000) DFU

1½

Pump and Syringe Modules Section

Page 73

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CHANNEL

SELECT

CHANNEL

OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Loading (Continued)

5. Lock syringe in place. a. Pull syringe barrel clamp out and hold. b. Rotate clamp to right (clockwise or counter clockwise)

until it lines up with syringe.

c. Gently release clamp against syringe.

6. Lower drive head and lock plunger in place with plunger grippers.

a. Twist gripper control clockwise and hold in position. b. While holding gripper control in open position, gently

lower drive head until it makes contact with plunger

flange. c. Gently release gripper control. d. Ensure plunger grippers lock and hold plunger in

place.

Syringe Barrel Clamp Closed

Gripper Control in

Closed Position



Drive Head Flush

with Plunger Flange

Plunger Grippers Closed

CAUTIONS

RATE(mL/h)

CHANNEL

1½

SELECT

PAUSE

1½

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

• To avoid an occlusion when loading a smaller size syringe, use extra care to close off administration set tubing and gently lower drive head against syringe plunger.

• For smaller syringes (such as;

1, 3 or 5 mL), stabilize the syringe

plunger with thumb and index finger while carefully lowering the drive head. Ensure the syringe plunger head makes contact with the small black sensor, located on the bottom of the drive head (between the plunger grippers).

Getting Started 2-9

Page 74

Syringe Module

SELECT

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Loading (Continued)

7. Insert pressure sensing disc (if used), as follows:



WARNING

When the pressure sensing disc is not being used and an occlusion

occurs, there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion. To avoid an inadvertent bolus, relieve the pressure before restarting the infusion.

Slot in Pressure

Sensing Disc

Housing

Pressure

Sensing Disc

Fluid Side

a. Orient pressure sensing disc, as follows:

• fluid side up (patient side down)

• cavity forward (membrane toward instrument)

b. Gently slide pressure sensing disc up into slot in

pressure sensing disc housing.

2-10 Getting Started

Patient Side

PAUSE

CHANNEL

OFF

RESTART

Pressure Sensing Disc

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 75

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Loading (Continued)

c. Apply firm upward pressure on pressure sensing disc

(not tubing) until disc snaps into place.

NOTES:

 The gripper control is spring loaded. When twisted to the

open position and then released, it (and the plunger grippers) returns to the closed position.

 The following Syringe Module features are available only

with extension sets fitted with a pressure sensing disc: (See "General Information", "Features and Displays" for definitions.)

Auto Pressure Back Off (upon occlusion) Customizable Pressure Alarm Settings (see "Occlusion

Pressure" feature definition) Dynamic Pressure Display (see "Pressure Tracking" feature

definition) Fast Start

Priming - Using Options Menu

The Priming option can be enabled at the time the Alaris® System is configured for use. The Priming selection (

PRIME

soft key) is available only after the syringe and infusion type have been selected, and prior to beginning an infusion.

If a pressure sensing disc is in use, it should be removed from the instrument before priming. See the applicable procedure (as follows) depending on whether or not a pressure sensing disc is used.



WARNING

When priming:

• Ensure administration set is not connected to patient.

• Ensure air is expelled from line prior to beginning infusion (unexpelled air in line could have serious consequences).

Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient.

CAUTION

During priming, the pressure limit

alarms are temporarily increased to their maximum level.

Alaris® System (with v9 Model 8000) DFU

Getting Started 2-11

Pump and Syringe Modules Section

Page 76

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Using Options Menu (continued)

Administration Set With Pressure Sensing Disc

1. Ensure administration set is not connected to patient.

2. If installed, remove pressure sensing disc from instrument.

• Using a finger, apply firm downward pressure on pressure sensing disc (not tubing) until disc snaps loose from slot in pressure sensing disc housing.

3. Press OPTIONS key.

CAUTION

The pressure sensing disc, if left installed during priming, can trap air that may not be totally expelled. To ensure entrapped air is eliminated, it is recommended that the pressure sensing disc be removed prior to priming and the membrane gently massaged with a finger while priming. After priming is completed, reinstall the pressure sensing disc.

SILENCE

OPTIONS

SYSTEM

2-1 2 Getting Started

CLEAR

Alaris® System (with v9 Model 8000) DFU

ENTER

CANCEL

Pump and Syringe Modules Section

Page 77

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Using Options Menu (continued)

Administration Set With Pressure Sensing

Disc (Contin ued)

4. Press Prime Set with Syringe soft key.

• If pressure sensing disc was not removed prior to pressing Prime Set with Syringe soft key, a pressure sensing disc removal prompt displays.

Channel Options 1 of 2

Guardrails Drugs

Guardrails IV Fluids

Multidose

Pressure Limit - 550 mmHg

Prime Set with Syringe

>Select an Option or EXIT

EXIT

It is recommended that the Pressure Sensing Disc be removed during priming.

Press CONFIRM and continue priming.

PAGE

DOWN

>Press CONFIRM

CONFIRM

5. Invert pressure sensing disc so that patient side is up.

6. Hold pressure sensing disc between

2 fingers.

Patient Side

Alaris® System (with v9 Model 8000) DFU

Getting Started 2-13

Pump and Syringe Modules Section

Page 78

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N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Using Options Menu (continued)

Administration Set With Pressure Sensing

Disc (Contin ued)

7. Press and hold PRIME soft key.



8. Gently massage pressure sensing disc to ensure all air is expelled. Disc must remain inverted only until air is expelled. Continue to gently massage disc throughout priming to ensure it does not become under- or over-filled.

9. Continue to prime until fluid flows and priming is complete.

10. When priming is complete, release pressure sensing disc

PRIME soft key.

and



Prime Set with Syringe

CAUTION: Do not prime with disposable set connected to patient!

Prime Volume

>Press and Hold PRIME

EXIT

PRIME

Prime Set with Syringe

CAUTION: Do not prime with disposable set connected to patient!

Prime Volume

2mL

>Press and Hold PRIME

EXIT

PRIME

2-1 4 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 79

Syringe Module

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Using Options Menu (continued)

Administration Set With Pressure Sensing

Disc (Contin ued)

11. Reinstall pressure sensing disc, as follows: a. Orient pressure sensing disc, as follows:

• fluid side up (patient side down)

• cavity forward (membrane toward instrument)

b. Gently slide pressure sensing disc up into slot in

pressure sensing disc housing.

c. Apply firm upward pressure on pressure sensing disc

(not tubing) until disc snaps into place.

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

• If EXIT soft key is pressed before pressure sensing

disc is reinstalled, a prompt to reinstall pressure sensing disc displays.

Slot in Pressure

Sensing Disc

Housing

Pressure

Sensing Disc

Patient Side

Re-install Pressure Sensing Disc.

Fluid Side

Pressure Sensing Disc

Alaris® System (with v9 Model 8000) DFU

>Press CONFIRM

CONFIRM

Getting Started 2-15

Pump and Syringe Modules Section

Page 80

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Using Options Menu (continued)

Administration Set With No Pressure Sensing Disc

1. Press OPTIONS key.

2. Press Prime Set with Syringe soft key.

3. Press and hold PRIME soft key until fluid flows and priming is complete.

4. Release PRIME soft key.





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

NOTES:

 When manually priming (per hospital/facility protocol) and an

administration set having a pressure sensing disc is in use, depress the disc between 2 fingers while priming and prime uphill (distal end of pressure sensing disc/tubing pointing upward).

 Fluid is delivered during priming only while the PRIME soft

key is pressed. Each press of the PRIME soft key delivers up to 2 mL of priming fluid per continuous press. To deliver additional amounts, press the PRIME soft key again.

 Volume used during priming is displayed but not added to

VTBI or VI.

Channel Options 1 of 2

Guardrails Drugs

Guardrails IV Fluids

Multidose

Pressure Limit - High

Prime Set with Syringe

>Select an Option or EXIT

EXIT

PAGE

DOWN

2-16 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 81

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N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Manual

Use the following procedures to manually prime the administration set.

Administration Set With Pressure Sensing Disc

1. Ensure administration set is not connected to patient.

2. If installed, remove pressure sensing disc from instrument.

• Using a finger, apply firm downward pressure on

pressure sensing disc (not tubing) until disc snaps loose from slot in pressure sensing disc housing.

WARNING

When priming:

• Ensure administration set is not connected to patient.

• Ensure air is expelled from line prior to beginning infusion (unexpelled air in line could have serious consequences).

Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient.

CAUTION

Alaris® System (with v9 Model 8000) DFU

Getting Started 2-1 7

Pump and Syringe Modules Section

Page 82

S T

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Manual (Continued)

Administration Set With Pressure Sensing

Disc (Contin ued)

3. Invert pressure sensing disc so that patient side is up.

4. Hold pressure sensing disc between 2 fingers.

5. Slowly prime set while gently massaging pressure sensing disc to ensure all air is expelled. Disc must remain inverted only until air is expelled. Continue to gently massage disc throughout priming to ensure it does not become under- or over-filled.

6. When priming is complete (no air exists), close set clamp.

Administration Set With No Pressure Sensing Disc

1. Prime per hospital protocol.

Patient Side

2. When priming is complete (no air exists), close set clamp.

Eliminate Mechanical Slack

To eliminate mechanical slack or free play, and minimize delays in the delivery of medication, especially when infusing at a rate lower than

1.0 mL/h, it is recommended that the

instrument be primed per the following procedure.

1. Load syringe (see "Loading" procedure). If a pressure sensing disc is being used, do not install disc until priming is complete.

2. Select syringe and infusion type (see "Programming" chapter).

2-18 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 83

S T

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Preparing Syringe and Administration Set (Syringe Module) (Continued)

Priming - Manual (Continued)

Eliminate Mechanical Slack (Continued)

3. Open administration set clamp.

4. Prime, as follows, using Priming option (see "Priming Using Options Menu"):

a. Follow applicable procedure (based on whether or

not pressure sensing disc is installed) through step to

press and hold PRIME soft key. b. Prime until fluid drips from end of tubing. c. Complete procedure (installing pressure sensing disc,

if applicable, and exiting options menu).

Alaris® System (with v9 Model 8000) DFU

Getting Started 2-19

Pump and Syringe Modules Section

Page 84

THIS PAGE

INTENTIONALLY

LEFT BLANK

2-20 Getting Started

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 85

References throughout this procedure to specific drugs and

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

drug doses are for illustration purposes only. Reference specific drug product labeling for information concerning appropriate administration techniques and dosages.

See "General Information", "Features and Displays" and the PC Unit Section of this DFU for information about:

• Displays

• Operating Features, Controls, Indicators The majority of user interface programming is identical for both

the Pump Module and Syringe Module. When referring to both modules, the term "infusion modules" is used.

Primary Infusion - With Guardrails

Suite MX Protection

Programming

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

The following procedures are to be used only when the drug to be infused is listed in the Drug Library. To access the Drug Library, a hospital-defined best-practice Data Set must be transferred using the Editor Software and the Profiles feature must be enabled.

1. Perform following steps (see PC Unit Section of this DFU, "General Setup and Operation", "Start-Up"):

a. Power on system. b. Choose Yes or No to New Patient? c. Confirm current profile or select a new profile. d. Enter patient identifier, if required.

2. Prepare and load syringe/administration set (see "Getting Started").

3. Prime (see "Getting Started").

WARNING

When the pressure sensing disc is not being used and an

occlusion occurs, there is a risk

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

of infusing pressurized buildup of infusates upon correction of the occlusion. To avoid an inadvertent bolus, relieve the pressure before restarting the infusion.

N E I

S T

N D

Alaris® System (with v9 Model 8000) DFU

Programming 2-21

Pump and Syringe Modules Section

Page 86

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

4. Press CHANNEL SELECT key.

Suite MX Protection (Conti n ued)

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

5. Syringe Module: Select syringe type and size, as



follows; otherwise, proceed to step

a. Press soft key next to installed syringe type and size.

If a default syringe list has been enabled and correct syringe cannot be found, press

ALL SYRINGES soft

key.

WARNING

Ensure the displayed syringe

manufacturer and syringe

size correctly identify the

installed syringe. Mismatches may cause an under-infusion or over-infusion to the patient that could result in serious injury and/or death. For a list of compatible syringes, see "General Information", "Compatible Syringes". If the installed syringe is displayed and selected, but is not recognized, servicing is required (see

Maintenance"

" in "Appendix" Section of this DFU

, "Service

Syringe Selection

BD 30 mL

Monoject 30 mL

Information"

>Select Syringe Size

ALL

CONFIRM

SYRINGES

2-22 Programming

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 87

S T

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

b. To accept, press CONFIRM soft key.

6. Start applicable infusion, as described in following procedures:

Continuous Infusion Bolus Dose Intermittent Infusion IV Fluid Infusion

NOTE:

 At the start of a Syringe Module infusion program, the system

prompts to select and confirm the syringe type and size. The system automatically detects the syringe size, and lists syringe types and sizes that most closely match the installed syringe. If the syringe is not recognized, Syringe not recognized displays.

Syringe Selection

BD 30 mL

Monoject 30 mL

>Confirm Syringe Size

ALL

CONFIRM

SYRINGES

Continuous Infusion

When using a drug listed in the Drug Library, the drug parameters are automatically calculated, based on:

• drug selected

• weight entry (if required)

• rate or dose entry

VTBI entry (Syringe Module: if other than All)

•

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Programming 2-23

Page 88

S T

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Continuous Infusion (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

1. Press Guardrails Drugs soft key.

2. Press soft key next to desired drug.

Infusion Menu

Guardrails Drugs

Guardrails IV Fluids

Basic infusion

>Select an Option or EXIT

RESTORE

EXIT



Guardrails Drugs

Adult ICU

Alteplase

AMIODArone

DOBUTamine

DOPamine

Heparin

A-E

F-J

K-O

P-T

U-Z

>Select Drug

DRUG

CALC

PAGE

DOWN

EXIT

• If applicable, an optional hospital-defined therapy

or clinical indication for delivery of this infusion may appear (as in illustrated example, which reflects use of Alteplase). Different limits can be defined for same drug with different therapeutic indications.

Therapy indication appears on drug or IV fluid confirmation screen. Once drug or IV fluid has been confirmed, therapy indication appears in title bar.

-- Continued on Next Page --

2-24 Programming

Guardrails Drugs

Adult ICU

Alteplase

Stroke

>Select Therapy Type

DRUG

EXIT

LIBRARY

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 89

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Continuous Infusion (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL

OFF

RESTART

• If applicable, a weight-based or non weight-based

option for delivery of this infusion may appear (as in illustrated example, which reflects use of Heparin).

• If applicable, multiple concentration listings for delivery

of this infusion may appear (as in illustrated example, which reflects use of Dopamine).

Guardrails Drugs

Adult ICU

Heparin

Non-Weight based dosing

Weight based dosing

>Select Drug Unit Type

DRUG

EXIT

LIBRARY

Guardrails Drugs

Adult ICU

DOPamine

400mg/250mL

800mg/250mL

>Select Drug Unit Type

DRUG

EXIT

LIBRARY

3. To continue programming, press Yes soft key.

• Bolus dose units appear if Bolus Dose is enabled.

To change selection, press No soft key.

-- Continued on Next Page --

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section



Guardrails Drug Setup

Adult ICU

Alteplase 100 mg in 100 mL Is this correct?

THERAPY

Stroke

DOSING

mg/kg/h

UNITS BOLUSABLE

BOLUS

mg/kg

DOSING UNITS

Yes

>Press Yes or No

Programming 2-25

Page 90

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Continuous Infusion (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

• If Yes was selected and facility has defined a Clinical

Advisory for that drug, a message appears. To indicate information has been noted and continue programming, press

CONFIRM soft key.

• If Yes was selected to continue programming, drug

amount and diluent volume (if defined in Drug Library) are automatically entered for selected drug.

• If selected drug had "_ _ / _ _ mL" concentration, drug

amount and diluent volume need to be entered.

• If selected drug is not weight-based, Not Used

displays in

PATIENT WEIGHT field.

• If hospital/facility practice guidelines identify selected

drug as weight-based, prompt for a patient weight in kilograms appears (as in illustrated example, which reflects use of Alteplase).



Alteplase

Stroke

Clinical Advisory:

This dosing is for Acute Ischemic STROKE

>Press CONFIRM

CONFIRM

Alteplase

Stroke

DRUG

AMOUNT

100 mg

DILUENT VOLUME

100 mL

PATIENT WEIGHT

Used

TIME

hour

UNITS

DOSING

mg/kg/h

UNITS

[Conc]: 1 mg/mL

>Press NEXT to Confirm

DRUG

LIBRARY

Alteplase

Stroke

DRUG

AMOUNT

100

DILUENT VOLUME

PATIENT WEIGHT

TIME UNITS

DOSING UNITS

100

____

hour

mg/kg/h

[Conc]: 1 mg/mL

>Enter Patient Weight

DRUG

LIBRARY

4. Verify parameters are correct and press NEXT soft key to confirm.

2-26 Programming

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 91

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Suite MX Protection (Conti n ued)

Continuous Infusion (Continued)

5. An optional hospital-defined and editable starting value for continuous infusion dose may already be entered.

To make a rate or dose entry, press applicable soft key,

RATE or DOSE, and use numeric data entry keys (other

value is calculated and displayed).

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

Alteplase

Stroke

CONTINUOUS INFUSION

RATE

___

mL/h

VTBI

____

DOSE

_____

mg/kg/h

[Conc]: 1 mg/mL

>Select Rate or Dose

SETUP

BOLUS

6. To enter volume to be infused, press VTBI soft key and use numeric data entry keys.

 

• BOLUS soft key appears only if Bolus Dose is enabled

within selected profile, drug is bolusable, and a

VTBI is

entered.

• Syringe Module:

♦ When VTBI ALL is enabled, VTBI soft key is

inactive and estimated available volume in syringe displays. When

VTBI soft key is pressed, a new

value can be entered.

♦ When VTBI ALL is disabled and VTBI soft key is

pressed, estimated available volume in syringe displays.

Alteplase

Stroke

CONTINUOUS INFUSION

RATE

56.7

mL/h

VTBI

DOSE

____

0.81

mg/kg/h

[Conc]: 1 mg/mL

>Select VTBI

BOLUS

SETUP

Alteplase

Stroke

CONTINUOUS INFUSION

RATE

56.7

mL/h

0.81

Available: (55.5 mL)

mg/kg/h

VTBI

DOSE

ALL

[Conc]: 1 mg/mL

>Select VTBI

PAUSE

SETUP

BOLUS

START

Alaris® System (with v9 Model 8000) DFU

Programming 2-27

Pump and Syringe Modules Section

Page 92

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Continuous Infusion (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

7. Verify parameters are correct and press START soft key.

• If programmed continuous dose infusion is outside

Soft Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. If Yes soft key is pressed, programming continues; if No soft key is pressed, infusion needs to be reprogrammed.

Alteplase

Stroke

CONTINUOUS INFUSION

RATE

56.7 mL/h

VTBI

100

DOSE

0.81 mg/kg/h

[Conc]: 1 mg/mL

>Press START

PAUSE

Dose exceeds Guardrail limit of

SETUP

Alteplase Stroke

BOLUS

START

Yes

0.81 mg/kg/h. Proceed?

>Press Yes or No

• If programmed continuous dose infusion is outside

Hard Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. Infusion needs to be reprogrammed.

• If a dose outside of Soft Limit has been entered and

verified as correct, Message Display also shows either

LLL" for a low dose or "↑↑↑" for a high dose.

-- Continued on Next Page --

2-28 Programming

Alteplase

Stroke

Dose exceeds

Reprogram

Guardrails hard limit of 0.82 mg/kg/h.

>Press REPROGRAM

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Page 93

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Continuous Infusion (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

• If a Soft Limit is overridden, G icon displays. When G

soft key is pressed, all applicable out-of-range limits are listed.

8. Syringe Module: Attach administration set to patient.

NOTES: (Continued)  To view additional drugs/concentrations, press a soft key next

to a letter group to navigate through alphabet, and/or PAGE UP and PAGE DOWN soft keys.

 The facility may choose to prepopulate standard drug

concentrations, or leave an open entry (_ _ / _ _ mL) and allow the clinician to enter the desired concentration.

 Once a patient weight is entered, for any module, it is

automatically entered for any subsequent weight-based calculation.

 Pump Module: At rates less than 10 mL/h, the rate is

displayed to 2 decimal places, and the VTBI can be entered and is displayed to

 Pump Module: In the Drug Calculation mode, the system

infuses at the calculated rate rounded to the nearest onehundredth of a mL per hour (as displayed on programming screen). The rate shown in the Rate Display is rounded to the nearest one-tenth of a mL per hour.

Syringe Module: Starting the infusion before attaching the



administration set to the patient minimizes any potential bolus that can be released from pressure built up in the set due to normal syringe loading and priming.

2 decimal places.

Midtown Hospital Adult ICU

VTBI = 250 mL

VOLUME INFUSED

ADJUST

AUDIO



Alaris® System (with v9 Model 8000) DFU

Programming 2-29

Pump and Syringe Modules Section

Page 94

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Suite MX Protection (Conti n ued)

Bolus Dose

A bolus dose can be programmed at the beginning of, or during, an infusion. The drug being programmed must be a bolusable drug selected from the Drug Library or a non-library drug, as described in the following procedures.

   

1. Set up infusion as described in "Continuous Infusion" procedure, but do not start infusion.

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

2. Press

BOLUS soft key.

• If programmed continuous dose infusion is outside

Hard Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. Infusion needs to be reprogrammed.

3. An optional hospital-defined and editable starting value for bolus dose and/or bolus rate duration may already be entered.

To enter bolus dose, use numeric data entry keys.

• After a bolus dose and weight (if used) are entered,

VTBI and concentration [conc] alternate in Main

bolus Display.

• If no weight has previously been programmed in

system and bolus dose is weight-based, weight entry is empty.

• If programmed continuous dose is weight-based,

programmed weight displays.

• If bolus dose is not weight-based, Not Used displays

PATIENT WEIGHT field.

Alteplase

Stroke

CONTINUOUS INFUSION

RATE

56.7

mL/h

VTBI

100

DOSE

0.81

mg/kg/h

[Conc]: 1 mg/mL

>Press START

PAUSE

Alteplase Stroke

SETUP

BOLUS

BOLUS DOSE

DOSE

PATIENT WEIGHT

DURATION

____

unit/kg

[Conc]: 1 mg/mL

>Enter Bolus Dose

CONT-

SETUP

INUOUS

START

2-30 Programming

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Suite MX Protection (Conti n ued)

Bolus Dose (Continued)

4. To enter or change patient weight (if used), use applicable following procedure, depending on whether or not continuous dose is weight-based.

• To enter a weight when continuous dose is not weight-

based: a. Press

PATIENT WEIGHT soft key.

b. To enter patient weight, use numeric data entry

keys.

• To change weight when continuous dose is weight-

based: a. Press b. Press

SETUP soft key. PATIENT WEIGHT soft key.

c. To change patient weight, use numeric data entry

keys.

d. Press

NEXT soft key.

• If a continuous infusion is running, a prompt to confirm weight change appears.

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

Alteplase

Drug Calculation

Heparin

Stroke

Dose will recalculate

CONTINUOUS INFUSION

based on new weight. Adjust Dose or Rate if required. Accept weight change?

Yes

e. Press BOLUS soft key. f. To enter bolus dose, use numeric data entry keys.

5. Press

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

DURATION soft key.

>Select Yes or No

Programming 2-31

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Bolus Dose (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL OFF

RESTART

6. To enter bolus duration, use numeric data entry keys.

To deliver bolus dose at maximum safe rate possible for selected drug and setup, and automatically calculate bolus duration, press Rapid Bolus soft key.

TOTAL DOSE alternates with INFUSE AT rate.

•

7. Verify parameters are correct and press START soft key.

• If programmed bolus dose and/or bolus dose duration is outside Soft Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. If Yes soft key is pressed, programming continues; if No soft key is pressed, infusion needs to be reprogrammed.

• If programmed bolus dose and/or bolus dose duration

is outside Hard Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. Infusion needs to be reprogrammed.

• If a bolus dose outside of Soft Limits has been entered

and verified as correct, Message Display also shows either "

LLL" for a low dose or "↑↑↑" for a high dose.

• If a Soft Limit is overridden, G icon displays. When G soft key is pressed, all applicable out-of-range limits are listed.

Alteplase

Stroke

BOLUS DOSE

DOSE

0.090 mg/kg

PATIENT

70 kg

WEIGHT

DURATION

__min

(420 mL/h)

Rapid Bolus

TOTAL DOSE = 6.3 mg

BOLUS VTBI = 6.3 mL

>Enter Duration

CONT-

SETUP

INUOUS



Alteplase

Guardrails Drug Library

Stroke

Dopamine

BOLUS DOSE

DOSE

mcg/kg

0.090 71

SETUP

min

mg/kg

min

CONT-

INUOUS

(420 mL/h)

START

PATIE NT

PATIENT

WEIGHT

DURATION

INFUSE AT: 0.09 mg/kg/min

BOLUS VTBI = 50.0 mL

[Conc]: 800 mcg/mL

[Conc]: 1 mg/mL

>Press Start to Begin

>Press START to Begin Infusing Bolus Dose

Infusing Bolus Dose

PAUSE

Midtown Hospital Adult ICU

VTBI = 250 mL

Rapid Bolus

AUDIO

ADJUST

2-32 Programming

VOLUME INFUSED

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

S T

N D

CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Bolus Dose (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL

OFF

RESTART

Syringe Module: If bolus dose was programmed at beginning of infusion, attach administration set to patient.



Stopping Bolus Dose

The display examples in this procedure represent stopping a bolus dose which was programmed using the Drug Library. Even where the displays are different when stopping a bolus dose which was programmed using a non-library drug, the procedure is the same.

1. Press

2. Press

CHANNEL SELECT key. STOP BOLUS soft key.

Alteplase

Stroke

BOLUS DOSE

Dose Remaining:

Pt. Weight:

Time Left:

TOTAL DOSE = 6.3 mg

BOLUS VTBI = 6.3 mL

>Press START to Continue Infusing Bolus Dose

STOP

BOLUS

0.090 70

min

mg/kg

STARTPAUSE

3. To stop bolus and start continuous infusion, press Yes soft key.

Alteplase

Stroke

Stop Bolus and Start Continuous infusion?

Yes

>Press Yes or No

Alaris® System (with v9 Model 8000) DFU

Programming 2-33

Pump and Syringe Modules Section

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Bolus Dose (Continued)

Stopping Bolus Dose (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL

OFF

RESTART

4. To stop continuous infusion, press and hold CHANNEL OFF key un til a beep is heard (approximately

1.5 seconds).



Restoring Bolus Dose

A bolus dose can be restored after it has completed, either prior to or after the module has been turned off, as indicated in the following procedures.

The display examples in this procedure represent restoring a bolus dose which was programmed using the Drug Library. Even where the displays are different when restoring a bolus dose which was programmed using a non-library drug, the procedure is the same.

CHANNEL

SELECT

PAUSE

CHANNEL

OFF

RESTART

1. Bolus dose completed - module not turned off: a. Press

CHANNEL SELECT key.

b. Verify infusion parameters and press BOLUS soft key. c. Press d. Verify dosing parameters and press

RESTORE soft key.

START soft key.

2. Bolus dose completed - module turned off: a. Press b. Press c. Verify parameters and press d. Verify infusion parameters and press

2-34 Programming

CHANNEL SELECT key. RESTORE soft key.

NEXT soft key.

BOLUS soft key.

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Pump and Syringe Modules Section

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Bolus Dose (Continued)

Restoring Bolus Dose (Continued)

e. Press RESTORE soft key.

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL

OFF

RESTART

f. Verify dosing parameters and press

START soft key.

NOTES:

 If the Bolus Dose feature is enabled, the BOLUS soft key

appears in the Continuous Infusion screen and becomes active when a VTBI is entered.

 The bolus

infusion

VTBI cannot exceed the programmed continuous

VTBI.

 Programming and starting a bolus dose deletes any

programmed delay.

 If no continuous rate is entered, the infusion ends when the

bolus has been delivered. No

 To see details during the bolus infusion, press the

SELECT

key.

KVO infusion follows.

CHANNEL

 Syringe Module: Starting the infusion before attaching the

administration set to the patient minimizes any potential bolus that can be released from pressure built up in the set due to normal syringe loading and priming.

 The Pump Module keypad is used in the illustration but the

key is the same for the Syringe Module.

Intermittent Infusion

When using a drug listed in the Drug Library, the drug parameters are automatically delivered, based on:

• drug selected

• weight or body surface area (

BSA) entry (if required)

• dose entry

• rate or duration dose entry

• VTBI entry

Syringe Module: The

KVO option is disabled when an

intermittent infusion is programmed.

1. Press Guardrails Drugs soft key.

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Programming 2-35

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CHANNEL SELECT

CHANNEL OFF

PAUSE

RESTART

RATE(mL/h)

Primary Infusion - With Guardrails

Intermittent Infusion (Continued)

Suite MX Protection (Conti n ued)

RATE(mL/h)

CHANNEL SELECT

PAUSE

CHANNEL

OFF

RESTART

2. Press soft key next to desired drug.



• If applicable, an optional hospital-defined therapy

or clinical indication for delivery of this infusion may appear. Different limits can be defined for same drug with different therapeutic indications.

• If applicable, a weight-based, non weight-based, or

BSA-based option for delivery of this infusion may

appear.

• If applicable, multiple concentration listings for delivery

of this infusion may appear.

3. To continue programming, press Yes soft key.



To change selection, press No soft key.

Guardrails Drugs

Peds Oncology

Amifostine

Azathioprine

Bleomycin

Cytarabine

Daunorbicin

>Select Drug

BASIC

PRIMARY

SEC

Guardrails Drug Setup

Peds Oncology

Methotrexate _ _ _ mg/_ _ _mL was selected. Is this correct?

DOSING UNITS

mg/m

BSA

>Press Yes or No

A-E

K-O

P-T

U-Z

PAGE

DOWN

Yes

F-J

• If Yes was selected and facility has defined a Clinical

Advisory for that drug, a message appears. To indicate information has been noted and continue programming, press

CONFIRM soft key.

• If Yes was selected to continue programming, drug

amount and diluent volume (if defined in Drug Library) are automatically entered for selected drug.

• If selected drug had "_ _ / _ _ mL" concentration, drug

amount and diluent volume need to be entered.

• If selected drug is not weight-based, Not Used

displays in

PATIENT WEIGHT field.

-- Continued on Next Page --

2-36 Programming

Alaris® System (with v9 Model 8000) DFU

Pump and Syringe Modules Section

Alaris PC Unit 8000 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

General Contact Information